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STA Compact - Operator's Manual

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0% found this document useful (0 votes)

5K views

STA Compact - Operator's Manual

Uploaded by

Илья Лебедев

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OPERATOR’S

MANUAL

For in vitro Diagnostic Use Only

DIAGNOSTICA
STAGO
9, rue des Frères Chausson 28217
92600 Asnières (FRANCE) 0931033J
STA COMPACT ® OPERATOR'S MANUAL Table of Contents

INTRODUCTION 1

PREPARING THE STA COMPACT ® 2

TEST SETUP 3

LOADING OF PRODUCTS AND SAMPLES 4

CALIBRATION 5

PATIENT FILE MANAGEMENT 6

QUALITY CONTROL 7

MISCELLANEOUS SCREENS 8

MAINTENANCE 9

TROUBLESHOOTING 10

V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Revision Table

Revision Table

Manual Date Software List of Modifications

Version Version

V 1.A0 September 95 - Preliminary Version

V 1.A0 November 95 - Update Version except for Chapter No.7

V 1.0 January 96 103.xxx Original Version

V 1.0 April 96 103.xxx Revision Table:

Chapter No.4 - Pages: 41 to 43

V 1.0 June 96 103.xxx Front Page

Revision Table:

Chapter No.1 - Pages: 1 and 12

Chapter No.9 - Page: 35

V 1.0 November 96 xxx.xxx Revision Table:

Chapter No.9 - Addendum (1 page)

V 1.0 November 96 104.xxx Revision Table:

Chapter No.1 - Page 19

Chapter No.2 - Pages: All and Table of

Contents

Chapter No.3 - Pages: All and Table of

Contents

Chapter No.4 - Page: 1

Chapter No.6 - Pages: All and Table of

Contents

Chapter No.9 - Pages: 66 and 67

V 1.0 January 97 104.xxx Revision Table:

Chapter No.9 - Addendum #2 (3 pages)

V 1.0 March 97 104.xxx Revision Table:

Chapter No.9 - Pages 35 and 36

Note: introduction of pages dated November

96 according to software release 104.

V 1.0 November 97 104.xxx Revision Table:

Chapter No.9 - Page 24

Note: modification of the procedure to

change the needles.

V 1.0 - February 01
®
Revision Table STA COMPACT OPERATOR'S MANUAL

Manual Date Software List of Modifications

Version Version

V 1.0 February 98 104.xxx Revision Table:

Front Page: Modification of the reference

0931033D → 0931033E

Chapter No.2 - Pages 8, 9 and 13

Chapter No.9 - Page 14

V 1.0 March 98 104.xxx Revision Table:

Front Page: Modification of the reference

0931033E → 0931033F

Chapter No.1 - Pages: 15 and 16

Chapter No.9 - Page 6

Note: Modification of the procedure to

clean the Sample and product Drawers.

V 1.0 November 98 104.xxx Revision Table:

Front Page: Modification of the reference

0931033F → 0931033G

Signification of the symbols used on the

STA Compact: Adding three symbols.

Chapter No.2 - Page: 15

Chapter No.9 - Pages: 8, 19 and 22

V 1.0 December 99 104.xxx Revision Table:

Front Page: Modification of the reference

0931033G → 0931033H

Chapter No.1 - Pages: 18 to 20, 22

Chapter No.9 - Pages: 1 and 18

Note:
- Adding of the patent numbers
- Adding of the reference number for the
filter of the new optical module

V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Revision Table

Manual Date Software List of Modifications

Version Version

V1.0 February 01 106.xxx Revision Table:

Front Page: Modification of the reference

0931033H → 0931033J

Chapter No.1 - Pages: 17, 18, 20 to 27

Chapter No.3 - Pages 3 to 8

Chapter No.9 - Pages 8, 38, 69 to 70

Note:
- Warnings concerning the test configuration
- Adding the material safety data sheet of
the cooling liquid
- Definition of the washings
- TDEX utility

V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Signification of the Symbols Used on STA Compact ®

SIGNIFICATION OF THE SYMBOLS USED ON THE STA COMPACT ®

Alternating current

Direct current

Protective earth (ground)

Attention, consult ACCOMPANYING DOCUMENTS

Off (power: disconnection from the mains)

On (power: connection to the mains)

Type B equipment

Dangerous voltage

Potentially biohazardous liquid

Mask and safety eyewear must be worn

Disposable gloves must be worn

V 1.0 - November 98
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 1

1. INTRODUCTION 1

1.1. Intended Use 1

1.2. Installation 1
1.2.1. Installation Requirements 1
1.2.2. Installation Procedure 1

1.3. Principle of Clotting Methods 2

1.4. Principle of Photometric Methods 4

1.5. System Description 6

1.6. Description of the STA Compact ® System 8

1.6.1. STA Compact ®, System View 8
1.6.2. STA Compact ®, Front View 9
1.6.3. STA Compact ®, Rear view 10
1.6.4. STA Compact ®, View from Left Side 12
®
1.6.5. STA Compact , View from Right Side 14
1.6.6. Sample Drawer 15
1.6.7. Product Drawer 16
1.6.8. Measurement Unit 17

1.7. STA Compact ® Specifications 18

1.8. Warnings 21
1.8.1. General Warnings 21
1.8.2. Warnings Concerning the Handling of Biological Products 21
1.8.3. Warnings Concerning Test Configurations 21
1.8.4. Warnings Concerning Usage of Access Codes 22
1.8.5. Warnings Concerning the Analyzer 23
1.8.6. Warning concerning the use of biohazard material 24

V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

1. INTRODUCTION
1.1. Intended Use

For in vitro Diagnostic Use Only.

The STA Compact ® is an automated laboratory instrument designed to perform in vitro tests
which aid in the diagnosis of coagulation abnormalities as well as to assist in monitoring
anticoagulant therapy. The instrument is capable of performing clotting assays as well as
chromogenic and immunological assays on plasma samples.

1.2. Installation

1.2.1. Installation Requirements

Space Requirements:

Height 996 mm 39.2 in.

Width 2530 mm 99.6 in.

Depth 1100 mm 43.3 in.

☞ Caution! Observe the ventilation space given by the two spacers fixed at the back of the
instrument.

Power Supply:

Voltage and Tolerance 95 V ~ (± 15%)

115 V ~ (± 15%)
210 V ~ (± 15%)
230 V ~ (± 15%)

Frequency and Tolerance 50/60 Hz (47 to 65 Hz)

Rating 1400 VA maximum

1.2.2. Installation Procedure

STA Compact ® has to be installed only by authorized Service Representative. Moreover, if STA
Compact ® has to be moved, this must be imperatively performed by authorized Service
Representative who has the required tools to handle the instrument.

V 1.0 - June 96 1-1

Introduction STA COMPACT ® OPERATOR'S MANUAL

1.3. Principle of Clotting Methods

The detection system for clotting-time assays on the STA Compact ® instrument is based on
the increase of viscosity of the plasma being tested. This increase of viscosity is measured
through the motion of a stainless steel ball that is made to effect pendular swings on the two
curved rail tracks provided in the bottom of the cuvette containing the test plasma.
Constant pendular swings of the ball are created by an electromagnetic field that is applied
alternately on opposite sides of the cuvette by two independent coils. The energy of the
electromagnetic field can be varied depending on the test being performed (weak clot for
Fibrinogen, normal clot for all the others).

Receiving Coil

Cuvette Ball

Driving Coil
Driving Coil

Transmitting Coil

Fig. 1 - Physical Principle of Measurement System

At constant plasma viscosity, ball motion remains constant.

1-2 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Introduction

However, as soon as the plasma starts to clot (as a result of the coagulation process being
initiated by the addition of the clot starting reagent), the viscosity of the plasma starts to increase,
and this change in plasma viscosity affects ball movement, slowing it down. As the viscosity
increases, the oscillation amplitude of the ball swing decreases. An algorithm uses these
variations in oscillation amplitude to determine the clotting time.

Clotting

Fig. 2 - Ball Motion Schema

V 1.0 -January 96 1-3

Introduction STA COMPACT ® OPERATOR'S MANUAL

1.4. Principle of Photometric Methods

The detection of chromogenic assays on the STA Compact ® is based on the absorbance
(optical density: O.D.) of monochromatic (405 nm or 540 nm) light passing through the cuvette
as a chromogenic reaction takes place.

The principle of absorbance measurement is depicted by the diagram below. Incident light (I0)
entering the cuvette is partially absorbed by the reaction mixture as it passes through. The
transmitted light (I + Ip) is measured, and converted to absorbance by the following equation:

A = - log (I1/I0) Note: decimal logarithm.

I + Ip = I1
I0

Fig. 3 - Principle of Absorbance Measurement

The effect of stray light (Ip) is eliminated by taking two fairly close measurements of the light
transmitted.

I1 = I + Ip (first measurement which includes incident light and stray light),

I2 = Ip (second measurement while blocking the incident light, corresponds to the stray light).

When I2 is substracted from I1, the result is I, which is only the light transmitted from the incident
light. Ip is assumed to remain constant between the two measurements.
Incident light is provided by a tungsten-halogen lamp, and is made monochromatic by passing
through a 405 nm, or 540 nm, interference filter. This step occurs inside the optical module. A
system of fiber optics carries the monochromatic light from the optical module to the
measurement heads. Another set of optical fibers carries the transmitted light from the
measurement head to the photometry measurement board.

1-4 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Introduction

Measuring Head

Reference Fiber

Sensor
Photometry
Measurement
Board

Harness of 5
Optical Fiber
Bundles
CPU
Measurement
Board

RS232

Main CPU
Halogen Lamp with 405 nm and
540 nm Filters

Fig. 4 - Principle of Optical Module

The Beer-Lambert law is applied to convert absorbance to concentration of the substance being
measured :

A= εlC

A = Absorbance
ε = Molecular extinction coefficient
l = Optical path length
C = Concentration

Concentration of the chromophore being measured is proportional to the absorbance.

Note: All the optical density measurements are made with regard to the reference fiber.

V 1.0 - January 96 1-5

1-6
1.5.
Introduction

System Description

1
2
3
P
4
O 5
6
N
7
8
M
9
L 10
11
K
12

J 13

14
I
15

H 16

1
G
2

F 3

4
E

1 2 3 4 5 6 7

! R !

V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL

Fig. 5 - STA Compact ®, Analytical Cycle

STA COMPACT ® OPERATOR'S MANUAL Introduction

Figure 5 Legend:

➊ Pipetting Head Equipped with 3 Needles;

➋ Needle No.1 (Samples);
➌ Needle No.2;
➍ Needle No.3;
➎ Pneumatic Jack;
➏ Washing Wells;
➐ Measurement Station;
➑ Incubation area (16 positions);
➒ Measurement area (4 positions);
➓ Cuvette Loading Station;
Suction Head;

Cuvette Roll Drawer;

Cuvette Disposal Drawer;

Product Drawer;

Sample Drawer.

The STA Compact ® is capable of performing clotting assays as well as chromogenic and
immunological assays on plasma samples.
The primary sample tubes and the dilution buffers are loaded in the sample drawer. The position
of each sample tube is automatically detected by the Positive Identification System.
The control plasma vials, the calibration plasma vials as well as the reagent vials are loaded in
the product drawer where the temperature is monitored between 15°C and 19°C by a system
based on Peltier elements. The position of each vial is also automatically detected by the Positive
Identification System.
Sample plasmas, control plasmas as well as calibrator plasmas are pipetted by needle No.1
(pipetting head), then they are added in a cuvette at an incubation position.
Reagents to be added before the first incubation are pipetted by needle No.2 of the pipetting
head, then they are distributed in the related cuvette in incubation position.
Reagents to be added after the first incubation (mainly the start reagents) are pipetted by needle
No.3 of the pipetting head. If a preheating to 37°C is necessary, the reagents are moved from
needle No.3 up to heating tube No.3 (this one being just above). Then, with or without preheating,
those reagents are added in the related cuvette in measurement area.
A level detection system on each needle ensures accurate and precise dispensing of fluid
volumes. Carry over is minimized by rinsing the interior as well as the exterior of the needles,
each in its own well.
Test cuvettes are loaded onto the STA Compact ® from a roll of 1,000 cuvettes. At the cuvette
loading station, they are placed one-by-one in a shuttle. This shuttle is then moved to the
measurement station by a system based on a pneumatic jack.
At this station, the suction head picks up the cuvette and transfers is to the incubation zone. This
same head then transfers the cuvette from the incubation zone to the measurement zone then
from the measurement zone to the cuvette disposal container.
The incubation zone and the measurement zone are included in the same block which is
monitored at 37°C ± 0.5°C by a system based on Peltier elements.
These operating principles enable the instrument to process each test independently, and offer
a throughput that is virtually independent of the test time.

V 1.0 - January 96 1-7

Introduction STA COMPACT ® OPERATOR'S MANUAL

1.6. Description of the STA Compact ® System

1.6.1. STA Compact ®, System View

Fig. 6 - STA Compact ® , System View

➊ Front Cover
➋ Right-hand Door (Access to Pipettor and Cuvette Roll)
➌ Cuvette Disposal Drawer
➍ Product Drawer
➎ Sample Drawer
➏ Barcode Reader
➐ Left-hand Door (Access to Floppy Disk Drive)
➑ Keyboard
➒ VGA Color Monitor

1-8 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Introduction

1.6.2. STA Compact ®, Front View

Fig. 7 - STA Compact ® , Front View

WARNING! Observe the universal precautions to manipulate tubes or waste

containers which contain plasma or biohazardous materials.

Do not touch the moving parts.

➊ Floppy Disk Drive

➋ Barcode Reader
➌ Pipetting Head Equipped with 3 Needles
➍ Cuvette Roll Drawer
➎ Pipettor
➏ To change the Cuvette Roll, see chapter 2. of the STA Compact ® Operator’s Manual.
To change the Syringe Teflon Tip, see chapter 9. of the STA Compact ® Operator’s Manual.
➐ Cuvette Disposal Drawer
➑ Product Drawer
➒ Sample Drawer
➓ Electronic Boards

V 1.0 - January 96 1-9

Introduction STA COMPACT ® OPERATOR'S MANUAL

1.6.3. STA Compact ®, Rear view

Fig. 8 - STA Compact ®, Rear View

➊ External Communications, see detailed view on Fig. 9, below

➋ Air Filter
➌ Air Vents

1 - 10 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Introduction

N/U

3
4

Fig. 9 - External Communications

(Details of Zone No.1, Fig. 8)

WARNING! Switch off the instruments (STA Compact ®, monitor and printer)
when connecting the STA Compact ® to the monitor, the printer or
the keyboard.

Note: All the connected devices must comply with the IEC 950 or IEC 65 standards.

➊ Monitor Connector
➋ Host Computer Connector
➌ Keyboard Connector
➍ Printer Connector
N/U: Not used

V 1.0 - January 96 1 - 11
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.6.4. STA Compact ®, View from Left Side

Fig. 10 - STA Compact ®, View from Left Side

WARNING! Switch off the instruments (STA Compact ® and monitor) when
replacing the main and secondary fuses (replace only with fuses of
the specified type and current rating).

➊ Air Vent
➋ Secondary Fuses (see Fig. 11 below)
➌ GS Sticker (only for 210/230 V Instruments)
❹ Power Cord
❺ Warning Sticker
❻ ON/OFF Switch (green Led ON = Instrument ON)
➐ Main Fuses:

- 4 A for 210 V~ /230 V~ STA Compact ®;

- 8 A for 95 V~ /115 V~ STA Compact ®.

➑ Identification Sticker
➒ CE Sticker (only for 210/230 V Instruments)
➓ Patent Sticker

1 - 12 V 1.0 - June 96
STA COMPACT ® OPERATOR'S MANUAL Introduction

Fig. 11 - Secondary Fuses (Detail of Zone No.2, Fig. 10)

WARNING! Switch off the instruments (STA Compact ® and monitor) when
replacing the secondary fuses (replace only with fuses of the
specified type and current rating).

V 1.0 - January 96 1 - 13
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.6.5. STA Compact ®, View from Right Side

Fig. 12 - STA Compact ®, View from Right Side

WARNING! Observe the universal precautions to manipulate tubes or waste

containers which contain plasma or biohazardous materials.

Do not touch the moving parts.

➊ STA®- Cleaner Solution Container

➋ Used Liquid Container
➌ Buffer Reservoir
➍ Vacuum Reservoir
➎ Optical Module (To change the lamp, see chapter 9. of the STA Compact ® Operator’s Manual)
➏ Peltier Reservoir

1 - 14 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.6.6. Sample Drawer

Fig. 13 - Sample Drawer Cassette

WARNING! Do not touch the drawer while opening or closing.

Observe the universal precautions for biohazardous material while

manipulating tubes or cleaning the sample drawer.

➊ Zone for Pediatrics Tubes

➋ Position for Dilution Buffer Bottle
➌ Position for 5-ml tube
➍ Status LED:

ON = Tube in progress
OFF = Nothing
Blinking = Tube to remove

V 1.0 -March 98 1 - 15
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.6.7. Product Drawer

Fig. 14 - Product Drawer Cassette

WARNING! Do not touch the drawer while opening or closing.

Observe the universal precautions for biohazardous material while

manipulating tubes or cleaning the product drawer.

1 - 16 V 1.0 - March 98
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.6.8. Measurement Unit

Fig. 15 - Measurement Plate

WARNING! Observe the universal precautions for biohazardous material while

cleaning the measurement plate.

➊ Incubation Zone, 16 positions

➋ Measurement Zone, 4 clotting/photometry measurement heads in parallel

V 1.0-February 01 1 - 17
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.7. STA Compact ® Specifications

Type Multi-test analyser

Random mode
Clotting time, colorimetry and immunology.

Standards Complies with the standards:

– 230 V STA Compact ® : GS mark (IEC 1010, EN55011)
and CE marking (EN 60601-1-2 and German law EMVG)
– 115 V STA Compact ® : UL 3101-1 (Underwriters
Laboratory).
Sample Management – One drawer of 96 centrifuged primary tubes
Various dimensions:
* diameter: 11mm (3 ml) (0.43 in.)
* diameter: 11.6 mm to 13.4 mm (5 ml) (0.46 to 0.53 in.)
* length: 65 to 100 mm (2.56 to 3.94 in.)
– List of recommended tubes:
Sarstedt polypropylene tube (5 ml);
Sarstedt Monovette ® (3 ml and 5 ml);
Terumo ® Venoject ® II
Becton Dickinson Vacutainer ® Hemogard TM (5 ml and
10 ml).
– Positive identification
– Barcode reader
Product Management – 45 positions for different vial sizes
– Bar code reader
– Positive Identification
– Thermostatisation between 15°C to 19°C
– Control of stability and volume
Measurement Principle – Light Source: Tungsten-halogen lamp

– Analytical modes: clotting, colorimetry and immunology

– Clotting, change in medium’s viscosity detected by
electromagnetic sensors
– Colorimetry and immunology, monochromatic
measurement of O.D. at 405 nm and 540 nm respectively
(0 to 2.50 O.D.).
Pipetting Units – Based upon 250-µl syringe.
– Pipetted volumes: 5 to 200 µl.
Cuvettes – In the form of 1,000 cuvette rolls with predispensed
stainless steel ball
– Allows swinging movement of the ball (STAGO patent)
– Maximum usable volume : 400 µl,
– Minimum volume:
* 150 µl, clotting assays;
* 250 µl, photometry assays.
Patent No. – FR 8718348
– FR 8809151
– US 4918984
– JP 1939942
– EP 0325874

1 - 18 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

Operating Conditions – Impact resistance: according to current standards

– Temperature: + 15°C to + 35°C (+ 59°F to + 95°F)
– Humidity: 20 % to 80 %
– Altitude: < 2000 m

No direct sunlight on open drawers

Storage and Transport Temperature: - 20°C to +60°C (- 4°F to + 140°F)
Conditions Relative Humidity: 20 % to 80 %

Test Performance Intra-assay Reproducibility:

with Diagnostica Stago Normal Plasma Pathological Plasma
Products PT (sec) < 1.5% < 2%
APTT (sec) < 1.5% < 2%
Fibrinogen (sec) < 4% < 5%

Sample-to-Sample Less than 0.05%

Carry-Over

Environment Sound level: 70 dBA maximum,

Heat dissipation: 1400 W electrical maximum.

Main Power – Voltage and tolerance : 230 V (± 15%), 210 V (± 15%),

115 V (± 15%), 95 V (± 15%).
– Frequency and tolerance : 50 / 60 Hz (47 to 65 Hz)
– Rating: 1400 VA maximum.
– Number and type of power sockets : One 16 A plug
– Fuse protection : YES
– Inverter needed : not for micro-cuts
– Results of sudden loss of supply : tests in hand lost,
possibility to alter the hard disk.
Classification – Type of protection against electric shock: class I
equipment.
– Degree of protection against electric shock: type B
equipment.
– Degree of protection against harmful ingress of
water: ordinary equipment (enclosed equipment without
protection against ingress of water).
– Method recommended for disinfection: see chapter 9.
(Decontamination Procedure) of the STA Compact ®
Operator’s Manual.
– Degree of safety of application: equipment not suitable
for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
– Mode of operation: continuous operation.
Data Processing Hard disk, 40 M Bytes minimum;
8 microprocessors and one central unit, industrial PC

Bar Code Reader Type:

Scanteam 3700 Series model (Welch Allyn)

Operating principle: reading by CCD (Charged Coupled

Device), lighting by LED

Dimensions Height : 640 mm (25.2 in.)

Width : 975 mm (38.4 in.)
Depth : 720 mm (top) (28.3 in.)
657 mm (base) (25.9 in.)

V 1.0 - December 99 1 - 19
Introduction STA COMPACT ® OPERATOR'S MANUAL

Monitor Type:

VGA color monitor.

Space Requirements Height: 996 mm (39.2 in.)

Width : 2530 mm (99.6 in.)
Depth : 1100 mm (43.3 in.)

Keyboard Type:

AZERTY (102 keys) or QWERTY (101 keys) keyboard

(Cherry) according to languages

Dimensions : 210 x 490 mm (8.3 x 19.3 in.)

Approved : GS, CSA, UL.

Weight 140 kg (331 lbs)

Note : All the connected devices must comply with the IEC 950 or IEC 65 standards.

1 - 20 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.8. Warnings

1.8.1. General Warnings

Diagnostica Stago shall not be held responsible if the procedures

described in this manual are not strictly observed, or if procedures not
described in this document are used. Read the STA Compact ® Operator’s
Manual carefully and respect all the instructions given therein.
Respect all the recommendations described in the administrative and regulatory
documents such as those issued by GBEA (Guide de Bonne Exécution des Analyses de
Biologie Médicale, in France) or the CLIA-88 (Clinical Laboratory Improvement Act of
1988, in the United States of America) .

With regard to the handling of test reagents, calibrator plasmas, control plasmas and patients’
plasmas, read carefully the package inserts provided in the relevant reagent kits and respect
all the instructions.

Failure to follow the recommended instructions will adversely affect the safety and
effectiveness of the STA Compact ® analyzer system.

1.8.2. Warnings Concerning the Handling of Biological Products

Exercise Biohazard Precautions When Handling All Products (reagents, calibration plasmas,
control plasmas and patients’ plasmas). In the United States, all products should be handled at
the Biosafety Level 2. See CDC/NIH manual, Biosafety in Microbiological and Biomedical
Laboratories, 1984.

• Do not eat, drink or smoke in places where products are handled.

• Use disposable gloves to handle all products.
• Contact a physician immediately if any product is ingested, or comes in contact with open
lesions, mucous membranes, or breaks in the skin.
• Disposal of infectious and/or potentially infectious materials in accordance with all applicable
laws and regulations governing disposal of infectious materials.

Any surfaces or parts of the STA Compact ® Analyzer that come in contact with STA Compact ® products
must be considered contaminated and handled accordingly. See STA Compact ® Operator’s Manual
Chapters 2 and 9.

Decontaminate the STA Compact ® Analyzer before any repair or maintenance work is
performed. See STA Compact ® Operator’s Manual Chapter 9. for decontamination procedures.

1.8.3. Warnings Concerning Test Settings

Conditions required to optimise the accuracy and quality of the results

The quality of the results depends on various factors which are not all related to the instrument
or its configuration. In order to minimise the risks of incorrect results, it is therefore important to
respect the following recommendations:
– Pre-analytic conditions concerning the sample: to preserve the activity of the various
coagulation factors, the sample must be taken carefully and according to professional
standards in citrated tubes of specified concentration.
Care must then be taken with the quality of centrifuging, and with the storage temperature
of the sample before its analysis:
• hemolised, partially coagulated plasma (presence of micro-clots), damaged by the
temperature or with bubbles on the surface may cause false results.
• plasma which has been frozen may contain interfering precipitates when thawed, which
must be separated off before measurement.
– Pre-analytic conditions concerning the products and the reagents: the laboratory
must strictly comply with the instructions given by the manufacturer in the inserts of the
products and reagents. Poor reagent preparation as regards the reconstitution volume,
stabilisation time, stirring, the presence of bubbles accidental presence of a magnetic rod,
may lead to incorrect results.

V 1.0 - February 01 1 - 21
Introduction STA COMPACT ® OPERATOR'S MANUAL

– Configuration and condition of the instrument: The laboratory must make sure that
the test configuration complies with the instructions given by the reagent manufacturer,
especially for the volumes used, the incubation times, rinsing solutions, buffers, etc. In
addition, the instrument produces results from biological materials and although these
materials are implemented and measured by highly sophisticated computer-controlled
automated systems in order to optimise reliability and safety, it is impossible to guarantee
an error rate of zero.

Note: Studies carried out using the prothrombin reagent Neoplastin Plus have demonstrated
that the inconsistency rate (difference between two results > 15 %) on duplicate tests
is less than one in ten thousand. This rate can be compared with the error rate which
could be observed for tests in single determination. Note that where the incidence of
error is below one in ten thousand, it becomes difficult to qualify an error rate
experimentally and accurately.

This data indicates that if duplicate tests are carried out on the same sample, the error rate is
mathematically of the order of one in one hundred million, which although not zero can be
considered as negligible.

Contry-specific guidelines, where applicable, should be taken into account when performing
the assays.

The laboratory must make sure that the machine is regularly maintained, according to the
instructions given in the guide.

Lastly, the results produced by the instrument must always be analysed according to the
patient’s history, the clinical examination and any other biological results.

Test configurations provided by Diagnostica Stago have been individually validated for the
STA Compact ® analyzer, and any possible interferences among the reagents themselves have
also been evaluated.

If the laboratory decides to use other reagent systems and methods that have not been
validated by Diagnostica Stago for use with the STA Compact ® analyzer, validation of the new
system will be required. Validation will ensure that the carcteristics of the method are verified
on the one hand (3, 4), and, that any possible interactions between the new and the old products
are checked on the other hand.

2: NCCLS Document H21-A2:

“Collection, Transport, and Handling of Blood Specimens for Coagulation Testing and
Performance of Coagulation Assays”. Second Edition, Approved Guideline, 11, 23, 1991.

3: VASSAULT A. et al.:
“Protocole de validation de techniques”. Ann. Biol. Clin., 44, 686 - 745, 1986.

4: Title 42, Code of Federal Regulations. 493.1213 §2. February 28, 1992.

1.8.4. Warnings Concerning Usage of Access Codes

The different functions of the STA Compact ® analyzer may be grouped in two categories:
– routine functions (example: calibration run);
– change functions (example: creation and/or modification of test configurations), see Chapter
1.8.3. of the STA Compact ® Operator’s Manual.

All these functions are protected by access codes (see Chapter 8.2.2.3. of the STA Compact®
Operator’s Manual). The use of the routine functions will not have any effects on the observed
results. However, the use of change functions can affect test results.

Therefore, it is recommended that each laboratory assesses the consequences of the use of
the different functions before deciding on access code attribution.

1 - 22 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.8.5. Warnings Concerning the Analyzer

In order to avoid all electric shocks, it is imperative that the procedures described in this
operator’s manual be scrupulously respected.

In the USA, the STA Compact ® analyzer has been tested and found to comply with the limits
for a class B digital device, pursuant to Part 15 of the FCC rules.

The STA Compact ® analyzer transparent safety cover must be kept closed during testing.
Removal of the cover will stop testing in progress. Do not interfere with the switch on the analyzer
that detects the presence of the cover.

For most of the available screens on the STA Compact ®, printing of the information is ordered
either by pressing a function key (F6) or by selecting the “Print” function.
However, in certain cases, especially when there is a malfunction, it may be necessary to obtain
a hard copy of the screen. If testing is in progress on the STA Compact ®, this type of command
can disrupt the smooth course of the test flow and may even lead to stoppage of the analyzer.
For safety reasons, screen hard copy can be accessed only by pressing the two keys : Alt and
PrtSc simultaneously. This command should only be used in case of absolute necessity, for
instance, when such a recommendation appears on the STA Compact ® and/or monitor when
such a request is made by your local authorized Service Representative.

If the instrument must be switched OFF more than one week, follow the procedure hereafter:

– Remove all the tubes and products,

– Remove the containers (used liquid container and STA-Cleaner Solution),
– Eliminate the wastes (used liquid container and cuvettes) according to all applicable laws
and regulation governing disposal of infectious materials,
– Decontaminate the instrument:
– Passing the mandrel through the needle and cleaning the washing wells, see
section 9.2.2. of the STA Compact® Operator’s Manual,
– Cleaning the sample and products drawers and the measurement plate, see
section 9.2.3. and 9.2.4. of the STA Compact ® Operator’s Manual,

Before switching the instrument ON, follow the same decontamination procedure then place the
used liquid container and the cuvette waste back in their proper place. Check the Peltier reservoir
level too, see section 9.2.5. of the STA Compact ® Operator’s Manual.

V 1.0 - February 01 1 - 23
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.8.6. Warning concerning the use of biohazard material

AMERICAN BIOPRODUCTS COMPANY

Five Century Drive
Parsippany, New Jersey 07054
Telephone: (973) 631-1200
Telecopy: (973) 631-1618

MATERIAL SAFETY DATA SHEET (MSDS)

1/PRODUCT IDENTIFICATION

Trade Name: PROCOLD T1

Manufactured by: PROFROID S.A
178, rue du Fauge
Z.I. des Paluds
B.P. 1152
13782 Aubagne Cedex (France)
Telephone: 011.33.4.42.18.05.00

2/INFORMATION ON PRODUCT AND ITS INGREDIENTS

Litre bottle containing a synthetic chemical mixture of the following composition, intended for
use as a refrigeration fluid for clinical analyzers of the STA Compact ® line:

Inhibited monoethylene glycol: CAS* 107.21.1 (*) Chemical Abstracts Service

Denatured methyl alcohol: CAS 67.56.1
Denatonium benzoate CAS 3734.33.6

3/HAZARD IDENTIFICATION

Harmful by inhalation and if swallowed (R20/22)

4/FIRST-AID MEASURES

In case of contact with skin :

Wash with copious quantities of water and soap. Remove contaminated clothings if necessary.
If irritation persists or if skin lesion is observed, consult a physician.

In case of contact with eyes:

Wash eyes immediately with copious quantities of water for at least 10 minutes. If irritation
persists or if cut is observed, consult a physician (ophthalmologist).

In case of ingestion:
Rinse mouth with water and consult a physician.

In case of excessive inhalation:

Allow individual to rest in fresh air and consult a physician.

5/ FIRE-FIGHTING MEASURES

Fire or explosion hazards: None

Fire-fighting equipment/method:
Rec ommended:carbon dioxide (CO2) or powder extinguishers
Acceptable : foam or halogen extinguishers
Do not use: direct water jet

Protective measures while fire-fighting:

avoid inhalation of emitted fumes.

Other recommendations: None

1 - 24 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

6/Containment of Accidental spillages

In case of small spillages, rinse with copious quantities of water.

In case of large spillages, call competent authorities for help, wear protective eyeglasses and
rubber gloves, wash with copious quantities of water and segregate contaminated clothings.
To protect personnel, avoid excessive contact with skin and eyes.

7/HANDLING AND STORAGE

Keep product in original bottles tightly capped, or in containers made of glass, away from heat,
air and light as well as avoiding wide temperature ranges. Do not reuse empty containers.
Open and handle bottles with care. To avoid accidental product sprays into eyes or onto mucous
membranes, wear protective eyeglasses and appropriate clothings (e.g., gloves) while handling
product.
Do not smoke, drink or eat when near this product.
Do not warm product over a naked flame, or expose its fumes to a flame or to another source
of ignition (e.g. electrical equipment).
Do not inhale the warm fumes of the product.
Discard immediately all rags, sponges, filter papers an any other materials uses to mop up
product.
Always operate in a well ventilated area.

8/EXPOSURE PREVENTION AND PERSONNEL PROTECTION

Wear protective gloves and eye/face shields.

9/PHYSICAL AND CHEMICAL PROPERTIES

Bluish liquid wih a characteristic odor; pH 7.5; flash point of >100°C (ASY%+TMD 3278-82)
Specific gravity: 1.022 g/cubic centimeter
Water solubility: completely soluble
Solubility in other solvents:soluble in some solvents
Freezing Point: -17°C
Boiling Point: 98°C

10/ STABILITY AND REACTIVITY

The solution remains stable when stored as recommended.

11/TOXICOLOGICAL INFORMATION

Effects of ingestion:
The product has such a bitter taste that any accidental ingestion makes spitting out immediate.
The ingested material may cause irritation of the gastro-intestinal mucous membrane.

Contact with the skin and/or inhalation:

May induce allergic reactions

Contact with the eyes:

May induce redness and burning sensation

According to PROFROID S.A., the manufacturer of PROCOLD T1, available data have not
demonstrated any health hazard if the product is used correctly and as intended.

12/ECOLOGICAL INFORMATION

PROCOLD T1: Studies are in progress

Denatonium benzoate: Rainbow trout LD50 = 1,000 mg/litre 96 hours in fresh water
Shrimps LD50 = 400 mg/litre 96 hours in salt water

V 1.0 - February 01 1 - 25
Introduction STA COMPACT ® OPERATOR'S MANUAL

13/DISPOSAL CONSIDERATIONS

Collect waste fluids in appropriate containers and forward the latter to authorized dumping
facilities for disposal. Respect all applicable local, regional and national regulations for disposal
of waste materials.

14/TRANSPORTATION INFORMATION

Intact containers can be shipped by land, sea and air without any particular restrictions.

15/REGULATORY INFORMATION

CEE Labelling Xn Symbol, Harmful

Risk Advice R20/22 Harmful by inhalation or if swallowed
Safety Advice Respect all safety precautions for handling of chemicals.

16/OTHER PERTINENT INFORMATION

This product is intended for use only as a refrigeration fluid for of STA Compact ® analyzers
that are manufactured and marketed by Diagnostica Stago® .

Diagnostica Stago ® assumes no responsibility in case of inappropriate use.

This Material Safety Data Sheet (MSDS) is a complement to the product insert but does not
replace it.

The information contained herein has been compiled from data and inforamtion provided by
PROFROID S.A., the manufacturer of PROCOLD T1.
Diagnostica Stago ® neither offers any guarantees nor assumes liability in connection with the
use of this information, or in case of inappropriate handling of this product. Users should strictly
respect the instructions of the product insert.

It is the user’s responsibility to determine the suitability of this information and to ensure that
all appropriate safety precautions are respected.

1 - 26 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 1

1. INTRODUCTION 1

1.1. Intended Use 1

1.2. Installation 1
1.2.1. Installation Requirements 1
1.2.2. Installation Procedure 1

1.3. Principle of Clotting Methods 2

1.4. Principle of Photometric Methods 4

1.5. System Description 6

1.6. Description of the STA Compact ® System 8

1.7. STA Compact ® Specifications 18

V 1.0 - February 01
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.7. STA Compact ® Specifications

Type Multi-test analyser

Random mode
Clotting time, colorimetry and immunology.

Standards Complies with the standards:

– Analytical modes: clotting, colorimetry and immunology

1 - 18 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.8. Warnings

1.8.1. General Warnings

Diagnostica Stago shall not be held responsible if the procedures

Failure to follow the recommended instructions will adversely affect the safety and
effectiveness of the STA Compact ® analyzer system.

1.8.2. Warnings Concerning the Handling of Biological Products

• Do not eat, drink or smoke in places where products are handled.

Decontaminate the STA Compact ® Analyzer before any repair or maintenance work is
performed. See STA Compact ® Operator’s Manual Chapter 9. for decontamination procedures.

1.8.3. Warnings Concerning Test Configurations

Conditions required to optimise the accuracy and quality of the results

The quality of the results depends on various factors which are not all related to the instrument
or its configuration. In order to minimise the risks of incorrect results, it is therefore important to
respect the following recommendations:
– Pre-analytic conditions concerning the sample: to preserve the various coagulation
factors, the sample must be taken carefully and according to professional standards in
citrated tubes of specified concentration.
Care must then be taken with the quality of centrifuging, and with the storage temperature
of the sample before its analysis:
• hemolised, partially coagulated plasma (presence of micro-clots), damaged by the
temperature or with bubbles on the surface may cause inconsistent results.
• plasma which has been frozen will be more prone to heterogeneities than fresh plasma.
– Pre-analytic conditions concerning the products and the reagents: the laboratory
must strictly comply with the instructions given by the manufacturer in the inserts of the
products and reagents. Poor product preparation as regards the reconstitution volume,
stabilisation time, stirring, the presence of bubbles accidental presence of a magnetic rod,
may lead to incorrect results.

V 1.0 - February 01 1 - 21
Introduction STA COMPACT ® OPERATOR'S MANUAL

Note: Studies carried out on the prothrombin rate have demonstrated that when the
pre-analytic conditions are respected, the inconsistency rate (difference between two
results > 15 %) on duplicate tests is less than one in ten thousand. This rate can be
compared with the error rate which could be observed for tests in single determination.
Note that below one in ten thousand, it becomes difficult to qualify an error rate
experimentally and accurately.

Each laboratory must, therefore, considering the regulations applicable in each country, the
specificities and the population of the laboratory patients and the nature of each test, select
and validate the test method used.

The laboratory must make sure that the machine is regularly maintained, according to the
instructions given in the guide.

Lastly, the results produced by the instrument must always be analysed according to the
patient’s history, the clinical examination and any other biological results.

If the laboratory decides to use other reagent systems and methods that have not been
validated by Diagnostica Stago for use with the STA Compact ® analyzer, the whole system
should be re-validated. This re-validation will allow, on the one hand, to verify the methodology’s
characteristics(3, 4), and, on the other, to control the influence that these new reagent systems
may exert on those that already exist, and vice versa.

References:
1: KOEKPE J. A., McLAREN C. E. , WIJETUNGA A. AND HOUWEN B.:
“A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests”.
Am. J. Clin. Pathol., 102, 2, 242 - 246, 1994.
2: NCCLS Document H21-A2:
“Collection, Transport, and Handling of Blood Specimens for Coagulation Testing and
Performance of Coagulation Assays”. Second Edition, Approved Guideline, 11, 23, 1991.

3: VASSAULT A. et al.:
“Protocole de validation de techniques”. Ann. Biol. Clin., 44, 686 - 745, 1986.

4: Title 42, Code of Federal Regulations. 493.1213 §2. February 28, 1992.

1.8.4. Warnings Concerning Usage of Access Codes

All these functions are protected by access codes (see Chapter 8.2.2.3. of the STA Compact
® Operator’s Manual). The use of the routine functions will not have any effects on the observed
results. However, the use of change functions can affect test results.

Therefore, it is recommended that each laboratory assesses the consequences of the use of
the different functions before deciding on access code attribution.

1 - 22 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

1.8.5. Warnings Concerning the Analyzer

In order to avoid all electric shocks, it is imperative that the procedures described in this
operator’s manual be scrupulously respected.

In the USA, the STA Compact ® analyzer has been tested and found to comply with the limits
for a class B digital device, pursuant to Part 15 of the FCC rules.

If the instrument must be switched OFF more than one week, follow the procedure hereafter:

– Remove all the tubes and products,

V 1.0 - February 01 1 - 23
Introduction STA COMPACT ® OPERATOR'S MANUAL

1.8.6. Warning concerning the use of biohazard material

AMERICAN BIOPRODUCTS COMPANY

Five Century Drive
Parsippany, New Jersey 07054
Telephone: (973) 631-1200
Telecopy: (973) 631-1618

MATERIAL SAFETY DATA SHEET (MSDS)

1/ PRODUCT IDENTIFICATION

Trade Name: PROCOLD T1

Manufactured by: PROFROID S.A
178, rue du Fauge
Z.I. des Paluds
B.P. 1152
13782 Aubagne Cedex (France)
Telephone: 011.33.4.42.18.05.00

2/ INFORMATION ON PRODUCT AND ITS INGREDIENTS

Litre bottle containing a synthetic chemical mixture of the following composition, intended for
use as a refrigeration fluid for clinical analyzers of the STA Compact ® :

Inhibited monoethylene glycol: CAS* 107.21.1 (*) Chemical Abstracts Service

Denatured methyl alcohol: CAS 67.56.1
Denatonium benzoate CAS 3734.33.6

3/ HAZARD IDENTIFICATION

Harmful by inhalation and if swallowed (R20/22)

4/ FIRST-AID MEASURES

In case of contact with skin :

Wash with copious quantities of water and soap. Remove contaminated clothings if necessary.
If irritation persists or if skin lesion is observed, consult a physician.

In case of contact with eyes:

Wash eyes immediately with copious quantities of water for at least 10 minutes. If irritation
persists or if cut is observed, consult a physician (ophthalmologist).

In case of ingestion:
Rinse mouth with water and consult a physician.

In case of excessive inhalation:

Allow individual to rest in fresh air and consult a physician.

5/ FIRE-FIGHTING MEASURES

Fire or explosion hazards: None

Fire-fighting equipment/method:
Recommended: carbon dioxide (CO2) or powder extinguishers
Acceptable : foam or halogen extinguishers
Do not use: direct water jet

Protective measures while fire-fighting:

avoid inhalation of emitted fumes.

Other recommendations: None

1 - 24 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

6/ CONTAINMENT OF ACCIDENTAL SIPILLAGES

In case of small spillages, rinse with copious quantities of water.

7/ HANDLING AND STORAGE

8/ EXPOSURE PREVENTION AND PERSONNEL PROTECTION

Wear protective gloves and eye/face shields.

9/ PHYSICAL AND CHEMICAL PROPERTIES

10/ STABILITY AND REACTIVITY

The solution remains stable when stored as recommended.

11/ TOXICOLOGICAL INFORMATION

Contact with the skin and/or inhalation:

May induce allergic reactions

Contact with the eyes:

May induce redness and burning sensation

According to PROFROID S.A., the manufacturer of PROCOLD T1, available data have not
demonstrated any health hazard if the product is used correctly and as intended.

12/ ECOLOGICAL INFORMATION

PROCOLD T1: Studies are in progress

Denatonium benzoate: Rainbow trout LD50 = 1,000 mg/litre 96 hours in fresh water
Shrimps LD50 = 400 mg/litre 96 hours in salt water

V 1.0 - February 01 1 - 25
Introduction STA COMPACT ® OPERATOR'S MANUAL

13/ DISPOSAL CONSIDERATIONS

14/ TRANSPORTATION INFORMATION

Intact containers can be shipped by land, sea and air without any particular restrictions.

15/ REGULATORY INFORMATION

CEE Labelling Xn Symbol, Harmful

Risk Advice R20/22 Harmful by inhalation or if swallowed
Safety Advice Respect all safety precautions for handling of chemicals.

16/ OTHER PERTINENT INFORMATION

This product is intended for use only as a refrigeration fluid for of STA Compact ® analyzers
that are manufactured and marketed by Diagnostica Stago® .

Diagnostica Stago ® assumes no responsibility in case of inappropriate use.

This Material Safety Data Sheet (MSDS) is a complement to the product insert but does not
replace it.

It is the user’s responsibility to determine the suitability of this information and to ensure that
all appropriate safety precautions are respected.

1 - 26 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Introduction

Fig. 16 - Notice of liquid waste management

V 1.0 - Février 01 1 - 27
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 2

2. PREPARING THE STA COMPACT ® 1

2.1. Power-on Procedure 1

2.1.1. Access the Test Panel (Continue) 2
2.1.2. Modifying the System Date 2
2.1.3. Modifying the System Time 3
2.1.4. Deleting the Working File 3

2.2. The TEST PANEL Screen 5

2.2.1. Description of the TEST PANEL Screen 5

2.3. Loading the Roll of Cuvettes 8

2.3.1. Access the CUVETTE ROLL CHANGE Window 8
2.3.1.1. Access the CUVETTE ROLL CHANGE Window
from the Error Window 8
2.3.1.2. Access the CUVETTE ROLL CHANGE Window
from the TEST PANEL 9
2.3.2. Remove the Empty Roll 10
2.3.3. Install the New Cuvette Roll 10

2.4. Cuvette Disposal Bag Replacement 13

2.4.1. Removal of the Used Cuvette Disposal Bag 13
2.4.2. Loading of the New Cuvette Disposal Bag 13

2.5. Loading the Washing Solution Bottle 15

2.5.1. Access the WASHING SOLUTION LOADING Window 15
2.5.1.1. Access the WASHING SOLUTION LOADING Window
from the Error Window 15
2.5.1.2. Access the WASHING SOLUTION LOADING Window
from the TEST PANEL 16
2.5.2. Remove the Used Liquid Container 17
2.5.3. Replace the Used Liquid Container 17
2.5.4. Install the Washing Solution Bottle 17

2.6. Power-down Procedure 18

2.6.1. Reminders 18
2.6.2. Power-Off Procedure 18

V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2. PREPARING THE STA COMPACT ®

2.1. Power-on Procedure

The STA Compact ® instrument is designed to work around the clock.

ACTIONS RESULTS

Switch the ON/OFF switch of the printer to Printer is in stand-by.

the ON position.

Switch t h e O N / OF F s w itc h of STA The ON/OFF switch lamp on the STA

Compact ® to the ON position (I). This Compact ® lights up (green color) as well
switch is located on the left side of the STA as that on the monitor.
Compact ®, (see chapter 1.6. of the STA
Compact ® Operator’s Manual). The following message pops up:

STA Compact System

Press Del to access
MAINTENANCE routine

Switch the ON/OFF switch of the monitor The STA Compact ® does a software and
to the ON position. a system check.
If the STA Compact ® finds an error, an
error window will be displayed according
to the problem which has been detected.

The STA Compact ® logo appears.

Then, the STA Compact ® displays the

following window:

GLOBAL VERIFICATION DONE

Modify the System Date

Modify the System Time

Delete the Working File

Continue

with the cursor on Continue.

Wait for 25 minutes so that the product STA Compact ® ready for use.
temperature is stabilized.

V 1.0 - November 96 2-1

Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

2.1.1. Access the Test Panel (Continue)

START: GOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

ACTIONS RESULTS

To proceed, press the ↵ key (Continue). The TEST PANEL screen is displayed (see
description, chapter 2.2. of the STA
Compact ® Operator’s Manual).

The message: “Desorb Solutions (for

cleaning the needles) are missing”
appears.

Load the Desorb Solutions (see chapter

4.5. of the STA Compact ® Operator’s
Manual).

2.1.2. Modifying the System Date

START: GLOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

Note: The date modification can also be made from the SYSTEM STATUS screen (see
description, chapter 8.1.2.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

To correct the date, press the ↑ key to The following window is displayed:
reach Modify the System Date, then
confirm with the ↵ key. TYPE NEW DATE
(Format mm * dd * yyyy)

The separator (*) and the date display

format are defined within the Global
Options menu (see chapter 8.2.3.4. of
the STA Compact ® Operator’s Manual).

The new date is displayed in the upper right

corner of the screen.

The following window is displayed:

Type the new date according to the GLOBAL VERIFICATION DONE

displayed format and separator, then
confirm with the ↵ key. In this example: Modify the System Date
type the month (2 numbers), the * key, the
day (2 numbers), the * key and the year (4 Modify the System Time
numbers), then confirm with the ↵ key.
Delete the Working File

Continue

with the cursor on Modify the System Date

2-2 V 1.0 - November 96

STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.1.3. Modifying the System Time

START: GLOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

Note: The time modification can also be made from the SYSTEM STATUS screen (see
description, chapter 8.1.2.3. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

To correct the time, press the ↑ key to The following window is displayed:
reach Modify the System Time, then
confirm with the ↵ key. TYPE NEW TIME
(Format hh * mm * ss [a/p] )

The separator and the time display format

are defined within the Global Options
menu (see chapter 8.2.3.4. of the STA
Compact ® Operator’s Manual).

Type the new time according to the The new time is displayed in the upper
displayed format and separator, then right corner of the screen.
confirm with the ↵ key. In this example:
type the hour (2 numbers) the * key, the The following window is displayed:
minutes (2 numbers), the * key and the
seconds (2 numbers), then confirm with GLOBAL VERIFICATION DONE
the ↵ key.
Modify the System Date

Modify the System Time

Delete the Working File

Continue

with the cursor on Modify the System

Time.

2.1.4. Deleting the Working File

START: GLOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

☞ Caution! Verify that all the “confirm” or “to confirm” files have been transmitted and/or printed
before doing this operation.

There is no selection available here: all the files of the Working File will be deleted if
this option is chosen. To delete partly the Working File, access the TEST PANEL,
then see chapter 6.6. To Delete Patient Files from the Working File of the STA
Compact ® Operator’s manual).

ACTIONS RESULTS

To erase the Working File, press the ↑ The following window appears:
key to reach Delete the Working File,
then confirm with the ↵ key. DELETION OF THE WORKING FILE

Please type Y to confirm

Press the Y key to confirm deletion of the The f o llo w in g w in d o w is

Working File. displayed:

V 1.0 - November 96 2-3

Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Caution ! All patient files of the Working GLOBAL VERIFICATION DONE

File will be erased.
Modify the System Date

Modify the System Time

Delete the Working File

Continue

with the cursor on Modify the System Time.

Note: Delete the Working File is

displayed in grey; this option is no
longer available.

The patient files of the Working File are

erased.

2-4 V 1.0 - November 96

STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.2. The TEST PANEL Screen

The TEST PANEL screen is one of the main screens of the STA Compact ®.
In fact, it allows to:
– see the evolution of the running of the tests for all Patient Files (tubes loaded);
– process the file selected by the cursor (validation, transmission, printout...);
– access the FILE MODIFICATION screen;
– display the Main Menu;
It is the return point for all the other menus of the STA Compact ®.

2.2.1. Description of the TEST PANEL Screen

Fig. 1 - TEST PANEL Screen

➊ Available keys:

← → Use these keys to display the following tests (→) or the previous ones (←).

↑ ¯ Use these keys to display the following files (down: ↓ or the previous ones up: ↑).
↵ Το proceed with patient file processing: to add/delete/rerun the tests, etc... (see
description, chapter 6.3. of the STA Compact ® Operator’s Manual).
/ Options; press this key to access:
- the HELP screen which describes the color codes used in the TEST PANEL screen,
- the FILE MODIFICATION screen which selects block/unblock, rerun or delete one
or more tests of the Working File (see description, chapter 6.7. of the STA Compact ®
Operator’s Manual).

F11 Download of Working Lists

With this key, it is possible for the STA to request once again to the host computer the
working lists for all tubes already loaded which have not received their list during loading
step (see description, chapter 6.9. of the STA Compact ® Operator’s Manual).
Esc To select the Main Menu display:

Status - Loading - Files - Calib./Control - Setup - Maintenance - Halt

F1 To request opening of the sample drawer so long as the Main Menu is not displayed
(Key not documented on the screen).

V 1.0 - November 96 2-5

Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

F2 To request opening of the product drawer so long as the Main Menu is not displayed
(Key not documented on the screen).
➋ Name of the screen

➌ Complementary information (Name, First name, ... see description, chapter 8.2.3.3. of the
STA Compact ® Operator’s Manual) for the file on which the cursor is positioned.

➍ Identification of patient files; a color code indicates status:

– white : OK;
– yellow: STAT sample;
– grey : File for which a tube has been loaded but the list of tests is unknown (waiting for
teleloading from the host computer);
– green : A liquid level detection error has been detected;
– red : An error has been detected on one or several tests (see description in zone ➑
below).

The patient files are classified by chronological order of creation.

➎ Position occupied by each tube within the sample drawer. The µ symbol is displayed after
the indication of the tube position if the micro tube option has been chosen.

➏ Abbreviated name of each test

➐ Primary units for reporting results defined in the TEST SETUP screens (see chapter 3.1.1.7.
of the STA Compact ® Operator’s Manual).

➑ Zone for results display: several codes indicate the test status:

– “xxx.x” displayed in black : Test requested, in stand by;

– “—-.-” displayed in black : Test in process;

– “—-.-” displayed in red : Test rerun, for example following a technical

error (no ball detected...), less than minimum
time (< V. min.) or greater than maximum time
(>V. max.);

– Result displayed in black : result is technically correct (validated or to

validate);

– Result displayed in blue : result obtained by a redilution;

– Result displayed in dark red : an error has been detected for this result;

– Result displayed in light red : result obtained with an out of range quality
control or with a quality control not done;

– Block displayed in dark red : test blocked from the FILE MODIFICATION
screen (see description, chapter 6.7. of the
STA Compact ® Operator’s Manual);

– Err. displayed in dark red : technical error;

– > V max. displayed in dark red : for clotting tests; raw measurement is greater
than the maximum time; defined in the TEST
SETUP screens (see description, chapter
3.1.1.6. of the STA Compact ® Operator’s
Manual);

2-6 V 1.0 - November 96

STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

For calibration modes: graphic 2nd order

polynomial or graphic 3rd order polynomial,
raw data (sec, ∆O.D. or O.D./min.) greater
than raw data obtained for the highest
calibration point.
For immunological tests in kinetic 2-points with
calibration mode: 2nd order polynomial or 3rd
order polynomial, after redilution with the
parameter “Dilute further” (if over limit), (see
description chapter 3.1.1.6. of the STA
Compact ® Operator’s Manual), value
obtained once again out of ranges

– < V min displayed in dark red : for clotting tests; raw measurement less than
minimum time; defined in the TEST SETUP
screens (see description, chapter 3.1.1.6. of
the STA Compact ® Operator’s Manual);
For calibration modes: graphic 2nd order
polynomial or graphic 3rd order polynomial,
raw data (sec, ∆D.O. or O.D./min.) less than
raw data obtained for the lowest calibration
point.

– Lin displayed in dark red : insufficient linearity just for the colorimetric or
immunological tests (see description, chapter
3.1.1.6. of the STA Compact ® Operator’s
Manual);

– “QNS” display in dark red : quantity of plasma not sufficient;

Note: For results displayed in TEST PANEL, the printout limits have not been applied (see
description, chapter 3.1.3.3. of the STA Compact ® Operator’s Manual).

➒ The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red background

at the foot of the screen when the sample pipetting is blocked whether:

– voluntarily by the operator (Stop Sample Pipetting function , see description in chapter
8.1.5.1. of the STA Compact ® Operator’s Manual);
– or automatically by the STA Compact ® after the consistency check; if the required
assays cannot be done.

V 1.0 - November 96 2-7

Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

2.3. Loading the Roll of Cuvettes

• Cat. No.: 26453

To change a roll of cuvettes, the operator should:
– first, access the CUVETTE ROLL CHANGE window;
– second, remove the empty roll;
– third, install the new roll of cuvettes.

☞ Caution! Loading the roll of cuvettes shall be systematically followed by cuvette disposal bag
replacement (see below, chapter 2.4. of the STA Compact ® Operator’s Manual).

2.3.1. Access the CUVETTE ROLL CHANGE Window

There are two possibilities to access the CUVETTE ROLL CHANGE window:
– from an error window;
from the Main Menu from the TEST PANEL screen.

Note: The error window will be systematically displayed when the theoretical counter for the
number of cuvettes will reach the zero value.

2.3.1.1. Access the CUVETTE ROLL CHANGE Window from the Error Window

START: The following error window is displayed:

CUVETTE FEED

Cuvette Missing

Esc = Continue F1 = Load

ACTIONS RESULTS

Press the F1 key to change the cuvette roll. The following window is displayed:

CUVETTE ROLL CHANGE

Please, remove the empty roll

Space bar: Confirm Esc: Quit

Caution! If this window is not displayed,

press the Esc key to access
the TEST PANEL.

Proceed with the cuvette roll change

(see below, copy of help diagram No.1 and
detailed explanations).

Note: Help diagram No.1 can be found inside the right side door in a plastic sleeve. For
instruments with serial number higher than xxx1219, this diagram can be found inside
the right door.

2-8 V 1.0 - February 98

STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.3.1.2. Access the CUVETTE ROLL CHANGE Window from the TEST PANEL

START = TEST PANEL screen displayed:

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status - Loading - (...) - Halt

cursor positioned on Status.

Press the L key (Loading). The sub-menu is displayed:

Or press the → key to reach Loading, Samples F1

then confirm with the ↵ key. Products F2
Cuvettes
Washing Solution

with the cursor on Samples.

Press the C key (Cuvettes). The following window is displayed:

Or press the ↓ key to reach Cuvettes CUVETTE ROLL CHANGE

then confirm with the ↵ key.
Please, remove the empty roll

Space Bar: Confirm Esc: Abort

Proceed with the cuvette roll change

(see below, copy of help diagram No.1 and
detailed explanations).

Note: Help diagram No.1 can be found inside the right side door in a plastic sleeve. For
instruments with serial number higher than xxx1219, this diagram can be found inside
the right door.

V 1.0 - February 98 2-9

Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

Fig. 2 - Help Diagram No.1

for Loading the Roll of Cuvettes

1 9, rue des Frères Chausson

92600 Asnières (France)

1 4
8
DIAGN
STAGOOSTICA

5
2
9

3
10
7

0931024

2.3.2. Remove the Empty Roll

(see figure 2 above):

– Step 1 : Open the right side door;
– Step 2 : Pull the cuvette roll drawer;
– Step 3 : Raise the catch holding the reel and the catch holding the cuvette roll;
– Step 4 : Remove the reel by sliding it off its spindle;
– Step 5 : While holding the reel with one hand, guide the plastic film under the
positioning rollers;
– Step 6 : While still holding the reel with one hand, remove the cuvette roll by sliding
it off its spindle. Throw the empty roll away. Remove the plastic foam (which
levels the cuvettes) out of the loading rail if necessary.

2.3.3. Install the New Cuvette Roll

A reel is always attached to the roll of cuvettes; the two are connected by the plastic film on
which the STA Compact ® cuvettes are attached.
(see figure 2 above).
– Step 7 : Grasp the cuvette roll so that it is on the left and the reel is on the right.
Slide the cuvette roll along its spindle, lower the catch which holds the roll;
– Step 8 : Guide the film under the two positioning rollers. Do not twist it (the film will take
up its own position in the slide).
– Step 9 : Slide the reel onto its spindle and lower the catch which holds the reel on it.
– Step 10 : Before pushing back the cuvette roll drawer, see below.

Proceed with cuvette loading (see below).

2 - 10 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

START = CUVETTE ROLL CHANGE window with the message “ Please, remove the empty
roll” is displayed.

ACTIONS RESULTS

Press the Space Bar. The following window is diplayed:

CUVETTE ROLL CHANGE

Please rotate the reel manually

until the first cuvette is engaged
in the loading rail

ESC: Abort F10 Confirm

Turn the reel (arrow direction) until the The cuvettes are in the loading rail.
cuvettes are engaged correctly in the
loading rail.

Push back the cuvette roll drawer then If the STA Compact ® is stand-by, the
close the right side door (step 10, refer to following window appears:
help diagram No.1) then confirm with the
F10 key. CUVETTE ROLL CHANGE
TESTING

↵ = Begin

Space Bar: EMERGENCY STOP

If tests are in progress, skip to the next

RESULTS box below.

Press the ↵ key to start automatically the Then, the following window is displayed:
loading test.
CUVETTE ROLL CHANGE
Note: In case of problems, press the
Space Bar to stop the roll motor.

Cuvette number = 1000

Modify if necessary
↵ Save

V 1.0 - November 96 2 - 11
Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Confirm the number of cuvettes with the The following window appears:
↵ key if using a new roll.
WARNING - BIOHAZARDOUS WASTE!
Otherwise, enter the remaining number of USE UNIVERSAL PRECAUTIONS.
cuvettes and confirm with the ↵ key.
CUVETTE ROLL CHANGE

Please change the cuvette bin

F10 Confirm

Caution! Observe the universal

precautions to manipulate
biohazardous material.

Proceed with the cuvette disposal bag

replacement (see below the detailed
explanations).

2 - 12 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.4. Cuvette Disposal Bag Replacement

☞ Caution! After each cuvette roll replacement, the cuvette disposal bag shall be systematically
replaced. This plastic bag contains potentially infectious biological materials and
must be handled of in accordance with local existing regulations: use disposable
gloves.

Note: For all the cuvette disposal bag replacement steps, see the help diagram No.2 (see
figure 3 below). This diagram can be found inside the right side door in a plastic
sleeve. For instruments with serial number higher than xxx1219, it can be found
inside the right door.

2.4.1. Removal of the Used Cuvette Disposal Bag

Procedure:

– Step 1 : Remove the cuvette disposal drawer;

– Step 2 : Pull up the folded portion of plastic bag so that the bag can be closed;
– Step 3 : Remove the red band from the plastic bag and close the top of the plastic
bag tightly by tying a knot with the red band;
– Step 4 : Lift the plastic bag completely off the cuvette disposal drawer and
discard it in accordance with local existing regulations. Incineration is
recommended in most countries.
2.4.2. Loading of the New Cuvette Disposal Bag

– Take one of the plastic bags supplied with the box containing the cuvette rolls;

Procedure:

– Step 5 : Open the plastic bag and insert it into the cuvette disposal drawer;
– Step 6 : Push the bottom of the bag so that it will reach the bottom of the
metal container;
– Step 7 : Fold the plastic bag over the edges of the cuvette disposal drawer;
– Step 8 : Place the plastic bag while avoiding folds;
– Step 9 : Push back fully home the cuvette disposal drawer.

☞ Caution! Do not interfere with the function of the switch designed to detect the presence of
the cuvette disposal drawer.

– Press the F10 key to confirm the replacement of the cuvette disposal bag.

=> Return to the TEST PANEL screen.

V 1.0 -February98 2 - 13
Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

2 9, rue des Frères Chausson

92600 Asnières (France)

1 2 4 7 8

DIAGN
STAGOOSTICA

3 5 6 9

DIAG
NOSTICA
STAG
O

0931025

Fig. 3 - Replacement of Cuvette Disposal Bag

in Cuvette Disposal Drawer
(Help Diagram No.2)

2 - 14 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.5. Loading the Washing Solution Bottle

• Cat. No.: 00973 (STA® - Cleaner Solution).

To change the Washing Solution, the operator should:
– first, access the WASHING SOLUTION LOADING window;
– second, remove the waste bottle;
– third, move the used liquid container;
– fourth, replace the bottle of STA ® - Cleaner Solution.

☞ Caution! Handling of potientially infectious biological material. Observe local existing

regulations: use disposable gloves, mask and safety eyewear.

2.5.1. Access the WASHING SOLUTION LOADING Window

There are two possibilities to access the WASHING SOLUTION LOADING window:
– from an error window;
– from the Main Menu, from the TEST PANEL screen.

2.5.1.1. Access the WASHING SOLUTION LOADING Window from the Error Window

START: The following error window is displayed:

BACKGROUND TASK
___________________________

WASHING SOLUTION EMPTY

Intermediate reservoir not full
__________________________
Esc = Retry F1 = Load

ACTIONS RESULTS

Press F1 key to change the washing The following window appears:

Solution.
WARNING - BIOHAZARDOUS WASTE!
USE UNIVERSAL PRECAUTIONS!

WASHING SOLUTION LOADING

Please remove and throw out this bottle

F10 Confirm Esc Abort

Caution! Biohazardous Waste:

observe the universal precautions
to manipulate biohazardous
material.

Caution! If this window is not displayed,

press the Esc key to access the
TEST PANEL.

Proceed with the Washing Solution loading

(see below).

V 1.0 - November 98 2 - 15
Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

2.5.1.2. Access the WASHING SOLUTION LOADING Window from the TEST PANEL

START: TEST PANEL screen is displayed.

ACTIONS RESULTS

Press the Esc Key. The Main Menu is displayed:

Status - Loading - (...) - Halt

Press the L key (Loading) The sub-menu is displayed:

Or press the → key to reach Loading, Samples F1

then confirm with the ↵ key. Products F2
Cuvettes
Washing Solution

with the cursor on Samples.

Press the W key (Washing Solution) The following window appears:

Or press the ↓ key to reach Washing WARNING - BIOHAZARDOUS WASTE!

USE UNIVERSAL PRECAUTIONS!
Solution, then confirm with the ↵ key.
WASHING SOLUTION LOADING

Please remove and throw out this bottle

F10 Confirm Esc Abort

Caution! Biohazardous Waste:

observe the universal precau-
tions to manipulate biohazar-
dous material.

Proceed with the Washing Solution loading

(see below).

2 - 16 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

2.5.2. Remove the Used Liquid Container

☞ Caution! This container contains potentially infectious biological material and should be
disposed of in accordance with the regulations in force.

– Open the right panel of the instrument;

– carefully pull up the used liquid container (the one on the right), symbolized in yellow on the
WASHING SOLUTION LOADING window;
– as soon as possible, remove the plug from this container;
– then, fully withdraw the used liquid container;
– Press the F10 key to confirm the end of this operation;
– in the waste bottle, add 5% sodium hypochlorite solution so that the final concentration is
approximately 0.5% sodium hypochlorite;
– Allow to stand at least 30 minutes;
– Refit the original plug on the used liquid container;
– dispose of it in accordance with the regulations in force locally. Incineration is recommended
in most countries.

☞ Caution! Appropriately mark this used liquid container, never use it as new STA® - Cleaner
Solution bottle. This can lead to wrong results.

2.5.3. Replace the Used Liquid Container

Note: The empty STA® - Cleaner Solution bottle becomes the new used liquid container.
The message “Please, EMPTY then displace this bottle” is displayed.

– carefully pull up the empty STA® - Cleaner Solution bottle (the one on the left);
– as soon as possible, remove the plug from the bottle. To avoid any possible contamination
of tubing, place the end of the tubing in a receptacle;
– empty the STA® - Cleaner Solution bottle;
– insert the plug of the right position into the empty bottle;
– then, replace the empty bottle into its recess (right position). The closing of the switch
detecting the presence of the bottle should be heard;

☞ Caution! Do not interfere with the function of the switch designed to detect the presence of
the used liquid container.

– press the F10 key to confirm the end of this operation.

2.5.4. Install the Washing Solution Bottle

Note: The message “Please, install a new bottle” is displayed.

– take a new STA® - Cleaner Solution bottle;

☞ Caution! Do not swallow the STA® - Cleaner Solution (in-vitro usage only) and do not modify
its formulation; this can lead to wrong results.

– remove its plug;

– insert the system plug (left position) into the STA® - Cleaner Solution bottle;
– then replace the bottle into its recess (left position). The switch which detects the presence
of the container will close audibly;
– press the F10 key to confirm the end of this operation;
– confirm the indicated volume (2500 ml) with the ↵ key if a new bottle is used. Otherwise,
enter the remaining volume, then confirm with the ↵ key;
– close the right door of the instrument.

V 1.0 - November 96 2 - 17
Preparing the STA Compact ® STA COMPACT ® OPERATOR'S MANUAL

2.6. Power-down Procedure

2.6.1. Reminders

The STA Compact ® ‘s monitor switches off automatically after 20 minutes whether the STA
Compact ® instrument is executing measurements or not. If an error is detected then, the STA
Compact ® ‘s monitor comes back on to display the error message.

When all the tests are completed, the STA Compact ® goes to stand-by. All automatic
functions stop except for the temperature regulations.
Whenever reagents are still on board, we recommend to keep the STA Compact ® in the
stand-by mode. This allows automated control of the reagent stability by the system.

To temporarily stop sample pipetting, the Stop Sample Pipetting function should be used
(see description, chapter 8.1.5.1. of the STA Compact ® Operator’s Manual).

2.6.2. Power-Off Procedure

– unload all samples from the sample drawer;

– unload all bottles from the product drawer.

For these two operations, see chapter 4.10. of the STA Compact ® Operator’s Manual.

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status - Loading - (...) - Halt

with the cursor on Status.

Press the H key (Halt). The following screen appears:

Or press the → key to reach Halt, then STOP THE PROGRAM?

confirm with the ↵ key.
Y = Yes N = No

Press the Y key. Saving of the STA’s status.

The following screen appears:

END OF APPLICATION

Saving ...
Please wait

DO NOT SWITCH OFF

Then, the screen becomes:

END OF APPLICATION

Recording complete
you can switch the system off

2 - 18 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Preparing the STA Compact ®

ACTIONS RESULTS

Switch the ON/OFF switch of the STA The STA Compact ®, the monitor and the
Compact ® to the OFF position (O). This printer are switched off.
switch is located on the left side of the
STA Compact ® (see chapter 1.6. of the
STA Compact ® Operator’s Manual).

Switch OFF the monitor.

Then, switch OFF the printer.

V 1.0 - November 96 2 - 19
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 3

3. TEST SETUP 1

3.1. Description of Test Setup Parameters 1

3.1.1. Methodology (page 1 of 3) 1
3.1.1.1. Test Identification 2
3.1.1.2. Sample Definition 2
3.1.1.3. Diluent Definition 3
3.1.1.4. Reagent Definition (Ra, Rb, Rc, Rd ) 3
3.1.1.5. Washing Definition 4
3.1.1.6. Analysis Definition 5
3.1.1.7. Results 7
3.1.1.8. Validation Section 8
3.1.1.9. Redilution Conditions 8
3.1.2. Calibration Part (Page 2 of 3) 9
3.1.2.1. Calibration mode Definition 11
3.1.2.2. View Points 12
3.1.2.3. Calibrator Definition 12
3.1.2.4. Definition of Scales 14
3.1.2.5. Choice between Single/Duplicate for the Calibrators 14
3.1.2.6. Definition of Offset Corrector Plasma 14
3.1.2.7. Calibration Control Definition 14
3.1.3. Printout/Transmission of Results and Quality Control (Page 3 of 3) 15
3.1.3.1. Printout/Transmission 16
3.1.3.2. Usual Value Definition 16
3.1.3.3. Printout Limit Definition 16
3.1.3.4. Quality Control Definition 17
3.1.4. Dependent Tests 17

3.2. Access to the Test Setup Parameters 19

3.2.1. Access to the Test Setup Menu 19
3.2.2. Description of the TEST SETUP Screen 20
3.2.3. Access to the Screens of the Main Test Setup 21
3.2.4. Access to the Dependent Test Setup Screen 21
3.2.4.1. Access to the Dependent Test Setup Screen
from the TEST SETUP Screen 21
3.2.4.2. Access to the Dependent Test Setup Screen
from the Required Main Test Setup 22
3.2.5. Access to Setup Parameters 22

3.3. Modifying a Setup Parameter 23

3.3.1. Modification Procedure 23
3.3.2. Validation Procedure 23

3.4. Creation of a New Test 26

3.4.1. Main Test Creation 26
3.4.2. Dependent Test Creation 26

V 1.0 - February 01
Table of Contents, Chapter 3 STA COMPACT ® OPERATOR'S MANUAL

3.5. Test Order on the TEST PANEL Screen 27

3.6. Test Deletion 28

3.7. Test Updating 30

3.8. Calculated Tests 32

3.8.1. Introduction 32
3.8.2. Description of the Definition Parameters for a Calculated Test 33
3.8.3. Definition of Test [1] and Test [2] 33
3.8.4. Printout / Transmission Section 34
3.8.5. Definition of Calculation Formula 34

V 1.0 - February 01
STA COMPACT OPERATOR' S MANUAL Test Setup

3. TEST SETUP
For each test, there are three screens of test setup parameters:
−
®
page 1 of 3 for methodology, (see chapter 3.1.1. of the STA Compact Operator’s
Manual);
−
®
page 2 of 3 for calibration, (see chapter 3.1.2. of the STA Compact Operator’s Manual);
− page 3 of 3 for printing, for transmitting results, and for quality control, (see chapter 3.1.3
®
of the STA Compact Operator’s Manual).
For each dependent test, there is only one screen of test Setup parameters (see chapter
®
3.1.4. of the STA Compact Operator’s Manual)

3.1. Description of Test Setup Parameters

3.1.1. Methodology (page 1 of 3)

➊ List of possible functions:

PgDn Displays next page;

F4 Access to dependent tests;

Esc Displays the EXIT OPTIONS window (see description chapter 3.3.2. of the STA
®
Compact Operator’s Manual).

➋ Date of latest modification (saved by the operator)

➌ Test Identification

➍ Sample parameter definition

➎ Diluent parameter definition

➏ Reagent parameter definition

➐ Analysis definition

➑ Result definition

➒ Definition of the range of values for automatic confirmation of the results

➓ Selection of the automatic redilution parameters

Note :The definitions of each parameter are described in the following pages.
V 1.0 - November 96 3-1
Test Setup STA COMPACT  OPERATOR’S MANUAL

3.1.1.1. Test Identification

Abbreviation Abbreviated name of test.

(8 characters)

Name Complete name of test (used for printout).

(25 characters)

Method Type of measurement method.The

following choices are available:
* Clotting
* Chromogenic:
kinetic 2 - points;
kinetic D O.D.

* Immunology:
kinetic 2 - points;
kinetic D O.D.
* Calculated Result, see chapter
®
3.8. of the STA Compact
Operator’s Manual.

3.1.1.2. Sample Definition

Volume Amount of final sample volume in

microlitres (including dilution).Possible
choices: from 25 ml to 200 ml by step of
5 ml.
☞ Warning! The total volume (sample +
reagents) should be within
the following ranges:
- 150 µl to 400 µl for clotting
tests;
- 250 µl to 400 µl for
photometric tests.
Incu Incubation time of plasma alone (from 0
sec. to 999 sec.)
0 = no incubation

Dil. Dilution Ratio.

The following options are available:

- 1/1 - 1/20
- 1/2 - 1/30
- 1/3 - 1/40
- 1/4 - 1/50
- 1/5 - 1/60
- 1/6 - 1/80
- 1/7 - 1/100
- 1/8 - 1/160
- 1/10 - 1/200
- 1/12 - 1/400
- 1/15
☞ Warning! The 1:400 dilution is not
possible for sample volumes
less than 50 µl

Reminder : 1 / 6
↓ ↓
Sample volume Total Volume
(sample + diluent)

3-2 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.1.1.3. Diluent Definition

ID Diluent’s identification.
(8 characters)

Name Diluent’s name.

(6 to 15 characters)

Vial Amount of initial diluent volume (in

ml millilitres).

Stab Stability of diluent (in hours).Stability is

h checked after loading.

Min. Volume The volume of remaining diluent at

®
ml which the STA Compact will stop
running tests.

3.1.1.4. Reagent Definition (Ra, Rb, Rc, Rd )

ID Alphanumeric identification number of each

(8 characters) reagent.

Name Name of each reagent (Ra, Rb, Rc or Rd).

(6 to 15 characters)

Incu Incubation time of each reagent (from 0 to

sec 999 sec.).
0 = no incubation.
Minimum for incubation time = 30
seconds.Depending on the exceeding of the
time authorized for incubation, the following
options can be used:
* P (critical incubation): maximum allowable
over-incubation of 5 seconds;
* Nothing : maximum allowable over-
incubation of 30 seconds.
☞ Warning! Each exceeding of the
incubation time will lead to stop
the current analysis (cuvette
drop into waste) and to rerun it
automatically. So this
procedure must be really
dedicated to critical methods.
Note: The selection of the incubation time for the sample (see chapter 3.1.1.2. of the STA
®
Compact Operator’s Manual) as well as that for each reagent must be defined in
accordance with one of the following methods:
Incubation Methods
A Sample ➩ Incubation 1 ➩+ Rd

B Sample + Ra ➩ Incubation 1 ➩+ Rd

C Sample + Ra + Rb ➩Incubation 1 ➩ + Rd

D Sample + Ra + Rb + Rc ➩ Incubation 1 ➩+ Rd

E Sample + Ra ➩ Incubation 1 ➩ + Rb ➩ Incubation 2 ➩ + Rd

F Sample + Ra + Rb ➩ Incubation 1 ➩+ Rc ➩ Incubation 2 ➩ + Rd

V 1.0 - November 96 3-3

Test Setup STA COMPACT  OPERATOR’S MANUAL

Vol Reagent volume (in microlitres).Possible

µl choices:
from 25 µl to 200 µl by step of 5 µl.
☞ Warning! The total volume (sample
+ reagents) should be
within following ranges:
- 150 µl to 400 µl for
clotting tests;
- 250 µl to 400 µl for
photometric tests.
Vial Initial reagent volume in the vial (in
ml millilitres).

Stab Stability of each reagent (in

H hours).Stability is checked after loading.

Min. volume The volume of remaining reagent at

®
ml which the STA Compact will stop
running tests.

Washing Type of washing to be carried out before

and/or after each sampling of the
reagent being used

Before There are the following options for the

prewash:
∗ No: without prewash;
∗ Special: with a Desorb Solution
which has to be defined (see below) +
®
washing with the STA Compact -
Cleaner Solution (washing solution).
After There are the following options for the
post wash:
∗
®
Normal (with the STA Compact -
Cleaner Solution);
∗ Intensive (parametring from 10 to 25
pulses, by 1 pulse apart);
∗ Special with a Desorb Solution which
has to be defined (see below) +
®
washing with the STA Compact -
Cleaner Solution).
Type of washing to be carried out after
each sampling:
∗ Normal 5 pulses (with the STA
®
Compact -Cleaner Solution - washing
solution);
∗ Intensive (parametring from 10 to 25
pulses, by 1 pulse apart);
∗ Special with a Desorb Solution which
has to be defined (see below) +
®
washing with the STA Compact -
Cleaner Solution)

3-4 V 1.0 - February 01

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.1.1.5. Washing Definition

Fig 2– Pre and Post Washing Window

Desorb Alphanumeric identification number of the

(8 characters) Desorb Solution.

Name Complete name of the Desorb Solution.

(6 to 15 characters)

Vial Initial Desorb Solution volume (in millilitres).

Stability Stability of the Desorb Solution (in hours).

Stability is checked after loading.

Min. Volume The volume of remaining Desorb Solution at

®
ml which the STA COMPACT will stop running
tests.

3.1.1.6. Analysis Definition

Note : The following parameters differ for each type of measurement.

Clotting
Min. Time Minimum time: shortest time limit below
which no result will be given.In this case
there is “< V min. ” for this result.

Max. Time Maximum time: longest time limit above

which no result will be given.In this case
there is “> V max. ” for the result.

Mean Time Estimated average clotting time of all

patients. It is used by the software to adjust
the throughput and to avoid traffic problems
in the measurement zone.In routine
conditions the risk of traffic problems is
rather low. On the other hand, for a given
test on large series of plasma with very long
clotting times (anti-vitamin K treatment for
example), the mean time must be increased
®
to allow the STA COMPACT to slow down
the throughput.

V 1.0 - February 01 3-5

Test Setup STA COMPACT  OPERATOR’S MANUAL

Clot Type Nature of clot.The following options are

available:
* Normal: PT type clot;
* Weak: fibrinogenic type clot.

Kinetic 2-point Chromogenic (or Immunology)

First Point Time (in seconds) between the

dispensing of the start reagent and the
first point of optical reading.

Second Point Time (in seconds) between the

dispensing of the start reagent and the
second point of optical reading.

Kinetic O.D./min Chromogenic (or Immunology)

Linearity Min Minimum value of linearity acceptable for

each linear regression.

First Point Time (in seconds) between the

dispensing of the start reagent and the
first point of optical reading.

Second Point Time (in seconds) between the

dispensing of the start reagent and the
last point of optical reading.

Kinetic 2-point immunology with calibration mode: 2nd or 3rd order polynomial

Dilute further (if over limit) In the special case of an immunological

method in kinetic 2-point with calibration
mode: 2nd or 3rd order polynomial,
redilution level to use for out of range
results. Out of range results are defined
as
− ∆O.D. obtained greater than ∆O.D.
obtained for the highest calibration
point;
− or difference between the points of the
initial plateau greater than 50 mO.D.
(0.05 O.D.)
Redilution 1 Possible redilutions are:
- 1/1 - 1/20
- 1/2 - 1/30
- 1/3 - 1/40
- 1/4 - 1/50
- 1/5 - 1/60
- 1/6 - 1/80
- 1/7 - 1/100
- 1/8 - 1/160
- 1/10 - 1/200
- 1/12 - 1/400
- 1/15

3-6 V 1.0 - February 01

STA COMPACT  OPERATOR’S MANUAL Test Setup

Redilution 2 Dose-Hook effect detection.

Note : The dose-Hook effect is only
activated with STAGO barcoded
reagents. It cannot be manually activated.
No Dose-Hook effect is detected: In case
of the measure is greateer than the
maximum OD Limit ,“> V max” is
generated.
No Dose-Hook effect is detected : even if
the measure is greater than the maximum
OD limit, the test will be rerun according
to the redilution criteria. If the dose-Hook
effect still remains after the redilution 2, a
technical error (err ) will be generated.

Note : The following parameters apply to all the read-out methods.

Rd Heating Type of heating for the start reagent.The

following options are available:
∗ YES: start reagent preheated to 37 °C
inthe pipetting head just before
dispensing.For incubation methods E and
F (see chapter 3.1.1.4. of the STA
®
Compact Operator’s Manual) the
reagents Rb (method E) and Rc
(method F) are also preheated.
∗ NO: no preheating.
Stirring Type of stirring for the needle No.3 during
dispensing of start reagent (Rd) into the
cuvette in measurement position.The
following options are available :
∗ YES:stirring;
∗ NO : no stirring.
Note: If intermediate reagents are dispensed
before first incubation, then the cuvette
content is systematically stirred by a
lateral movement of needle No.2 in the
cuvette.
3.1.1.7. Results

Primary Units Primary units for reporting of results.The

following options are available:
* Raw: seconds, ∆ O.D. or O.D./min;
* %: percentage;
* Ratio: ratio of time to reference time;
* g/l: grams per litre;
* mg/dl: milligrams per decilitre;
* ng/ml: nanograms per millilitre;
* U/ml: units per millilitre;
* IU/ml: International Units per millilitre;
* µl /ml: micrograms per millilitre;
* INR: International Normalized Ratio;
* AU1: arbitrary unit No. 1;
* AU2: arbitrary unit No. 2;
* AU3: arbitrary unit No. 3.

Corrector Systematic multiplying factor applied only on

results given in primary units for reporting
results. This factor is not applied on control
results.

V 1.0 - February 01 3-7

Test Setup STA COMPACT  OPERATOR’S MANUAL

Single/Duplicate Type of determination, used for the samples,

the calibration controls and the quality
controls.The following two options are
available:
* Single determination;
* Duplicate determination.

☞
®
Caution! Please, see chapter 1.8. of the STA Compact Operator’s Manual.

Precision Maximum permitted difference for a duplicate

determination.The deviation is expressed
in percent (relative deviation compared to
the mean) and applies to the raw data, either
to the clotting time or to the D O.D. or
O.D./min for colorimetry and immunology.

Precision: -  M1 – M2 x100
M
- M1, M2: raw data
- M= (M1 + M2) / 2
For immunological tests in kinetic 2-point, the
absolute deviation is used and it is expressed
in mO.D..
This parameter has to be defined even for
single determination because it is necessary
for reruns (see chapters 6.3.3. and 6.7.4. of the
STA Compact ® Operator’s Manual).

3.1.1.8. Validation Section

Min. Max. Range of values given in the primary units

of reported results for which result
validation is automatically performed.

3.1.1.9. Redilution Conditions

Definition of two other dilutions for the sample if it is outside the linearity range.

☞ Caution! Redilution conditions have to be used with great care since they are not always
compatible with the principle of the measurement.

Note : For the followings units :

− Raw (seconds, ∆ O.D. or O.D./min)
− Ratio
− INR
− only the nominal dilution of the test can be used in case of rerun
e.g.:Test in INR, 100 µl of sample at 1/20 of dilution.This test can be rerun if the
result is greater and/or lower to a limit but only the 1/20 dilution will be accepted.

Note : The rediluted result will only be given in the primary units (use of secondary units is
not allowed in this case).

< “low limit” Low limit of the linearity zone in the primary
unit for reporting results.

> “high limit” High limit of the linearity zone in the primary
unit for reporting results.

3-8 V 1.0 - February 01

STA COMPACT  OPERATOR’S MANUAL Test Setup

“Dil. 1" < For the redilutions, the following options

”Dil. 2" > are available:
- 1/1 - 1/20
- 1/2 - 1/30
- 1/3 - 1/40
- 1/4 - 1/50
- 1/5 - 1/60
- 1/6 - 1/80
- 1/7 - 1/100
- 1/8 - 1/160
- 1/10 - 1/200
- 1/12 - 1/400
- 1/15
∗ NO (no redilution, so no limits to be
defined).
Example : For Fibrinogen, the linearity zone is given from 1.5 g/l to 9 g/l (150 to 900
mg/dl) for one single dilution (1/20). The following dilution conditions are defined :

1/10 < 1.5

1/40 > 9

It means that :
− for all results lower than 1.5 g/l (150 mg/dl), the assays will be automatically rerun with
a 1/10 dilution;
− for all results higher than 9 g/l (900 mg/dl), the assays will be automatically rerun with a
1/40 dilution.
− In both cases, the results will be given taking into account the dilution change, i.e. : for a
result>9g/l (900 mg/dl),resultx2.
3.1.2. Calibration Part (Page 2 of 3)
The page 2 of Test Setup is different depending on the calibration mode selected.
Fig. 3– Page 2 of Test Setup for graphic Mode

V 1.0 - November 96 3-9

Test Setup STA COMPACT  OPERATOR’S MANUAL

Fig. 4 – Page 2 of test Setup for Bar Coded Mode

Fig .5– Page 2 of Test for Raw Mode

3-10 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

Fig. 6–Page 2 of Test Seup for Ratio Mode

➊ Available functions:

PgDn displays next page;

PgUp displays previous page;

Esc displays the EXIT OPTIONS window (see description chapter 3.3.2. of the STA
®
Compact Operator’s Manual ).

➋ Abbreviation and complete name of test

➌ Calibration mode definition

➍ Calibrator definition or view point definition

➎ Definition of calibration controls

➏ Definition of scales

➐ Choice between Single/Duplicate for the calibrators

➑ Definition of offset corrector plasma

3.1.2.1. Calibration mode Definition

Mode Choice of calibration mode.There are

seven options:

*Bar code: Data transmitted by bar code

labels reserved for Diagnostica Stago
tests;

V 1.0 - November 96 3-11

Test Setup STA COMPACT  OPERATOR’S MANUAL

Graphic:
* Graphic linear: linear regression on a
minimum of 2 points (Y = ax + b);
* Graphic 2nd order polynom.: polynomial
regression of 2nd order on a minimum of 4
pts (Y=ax²+bx+c);
* Graphic 3rd order polynom. = polynomial
regression of 3rd order on a mininum of 6
3 2
points (Y=ax +bx +cx+d, reserved for
immunological tests);
* Graphic Hyperbolic: Hyperbolic regression
of a minimum of 5 points [Y=a+b/(x-N)];
Note: depending on the scale selected, x
or y may be transformed into log x,
log y, 1
y

Non graphic:
∗ Raw: Raw data : seconds, ∆ O.D. or
O.D./min;
∗ Ratio: Ratio with a reference time.
3.1.2.2. View Points

Note: These parameters are only available within bar coded calibration mode.

View Points Selected points (in primary units for

(8 maximum) reported results) which the user chooses to
view on calibration screen (see chapter
®
5.2.1. of the STA Compact Operator’s
Manual).

3.1.2.3. Calibrator Definition

Note : These parameters are only available within graphic calibration modes (linear, 2nd
order polynom, 3rd order polynom, or hyperbolic).

I.D.(8 characters) Alphanumeric identification of the 8

calibrators.This may be identical for the 8
calibrators. In this case, only the dilution
ratios change.

Key Only for the Diagnostica Stago products,

allows to choose, in a list corresponding to
the order of the parameters printed on the
bar code labels, the test or the reagent
concerned.

Name Complete name of each calibrator.

(6 to 15 characters)

3-12 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

Dil Choice of dilutions for each

calibrator.There are the following options:
- 1/ 1 - 1/20
- 1/ 2 - 1/30
- 1/ 3 - 1/40
- 1/ 4 - 1/50
- 1/ 5 - 1/60
- 1/ 6 - 1/80
- 1/ 7 - 1/100
- 1/ 8 - 1/160
- 1/10 - 1/200
- 1/12 - 1/400
- 1/15

Vial Initial calibrator volume in each vial.

Stab Stability of each calibrator (inhours).

h Stability is checked after loading.

Min. volume The volume of remaining calibrator at which

®
ml the STA Compact will not run another
calibration.

Note: It is possible to use different calibrators or a single calibrator. In both cases, the
dilution corresponding to each calibration point must be specified.
®
Example 1 : STA Compact - Hepanorm H (Cat. No. 00684)

The identifications and the names of the calibrators are different, the dilutions are
identical.
CALIBRATOR
DILUTION
ID. Name

12363 Hepanorm H0 1/1

12364 Hepanorm H3 1/1
12365 Hepanorm H6 1/1

®
Example 2 : STA Compact - Unicalibrator (Cat. No. 00675)
The identifications and the names of the calibrators are the same but the dilutions are
different.
CALIBRATOR
DILUTION
ID. Name

12350 Unicalibrator 1/10

12350 Unicalibrator 1/20
12350 Unicalibrator 1/40
12350 Unicalibrator 1/80

V 1.0 - November 96 3-13

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.1.2.4. Definition of Scales

Note : These parameters are only available for graphic calibration modes (linear, 2nd
order polynom, 3rd order polynom, or hyperbolic) and bar coded calibration mode.

Measures Definition of scales along the measurement

Concentrations and concentration axes.There are the
following options:
* Linear;
* Inverse (only the concentration axis);
* Log.

3.1.2.5. Choice between Single/Duplicate for the Calibrators

Note : This parameter is only available for graphic calibration modes (linear, 2nd order
polynom, 3rd order polynom, or hyperbolic).

Single/Duplicate Type of determination applicable to all

calibrators. There are two possible options:
* Single,
* Duplicate. In this case, each point is taken
as an individual value.

3.1.2.6. Definition of Offset Corrector Plasma

Note : The parameters for “Offset corrector” apply only for chromogenic and
immunological tests (only for linear regression mode). This correction corrects for
Y-intercept (the slope is maintained).

I.D. Alphanumeric identification of the plasma

(8 characters) used for the offset adjustment.

Key Just for Diagnostica Stago products, allows

to choose, in a list corresponding to the order
of parameters printed on the bar code labels,
the test or the reagent concerned.

Name Complete name of plasma used for the offset

(6 to 15 characters) adjustment.

Vial Initial offset corrector plasma volume in each

ml vial.

Stab. Stability of plasma (in hours).

h Stability is checked after loading.

Min. volume The volume of remaining offset corrector

®
ml plasma at which the STA Compact stops
running tests.

3.1.2.7. Calibration Control Definition

Note : The following parameters apply to all measurement methods and to all calibration
modes.

0 or 2 calibration validation controls can be defined. When 2 controls are used, they enable
®
automatic validation of the calibration (see chapter 5.3.1. of the STA Compact Operator’s
Manual). They have to be defined for the bar coded tests and when an offset corrector
plasma is used.

3-14 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

ID Alphanumeric identification of each control.

(8 characters)

Key Just for Diagnostica Stago products,allows to

choose, in a list corresponding to the order of
parameters printed on the bar code labels,
the test or the reagent concerned.

Name Complete name of each control.

(6 to 15 characters)

Vial Initial control volume (in millilitres).

Stab. Stability of each control (in hours).Stability is

hl checked after loading..

Min. volume The volume of remaining control at which the

®
ml STA CompacT will not run another
calibration control..

3.1.3. Printout/Transmission of Results and Quality Control (Page 3 of 3)

Fig. 7 Page 3 of Test Setup

➊ Available functions:

PgUp displays previous page;

Esc displays the EXIT OPTIONS window (see description chapter 3.3.2. of the STA
®
Compact Operator’s Manual).

➋ Abbreviation and complete name of the test

➌ Definition of parameters for Printout/Transmission

➍ Definition of Usual Value range

➎ Definition of Printout Limits

➏ Definition of Quality Controls

V 1.0 - November 96 3-15
Test Setup STA COMPACT  OPERATOR’S MANUAL

3.1.3.1. Printout/Transmission

Unit Besides the primary units, three secondary

units may be defined and used for the printout
and/or transmission.

Main Reminder of the primary unit as selected in the

result portion of test setup on page 1 of 3.

Aux. 1 Definition of three secondary units. There are

Aux. 2 the following options:
Aux. 3
* None: (no secondary unit);
* Raw:Seconds, ∆ O.D. (delta of the optical
density), or O.D./min (optical density per
minute);
* %: percentage;
* Ratio: ratio of test time to reference time;
* g/l: grams per litre;
* mg/dl: milligrams per decilitre;
* ng/ml: nanograms per millilitre;
* U/ml: units per millilitre;
* IU/ml: International Units per millilitre;
* µl /ml: micrograms per millilitre;
* A.U.1: arbitrary unit No. 1;
* A.U.2: arbitrary unit No. 2;
* A.U.3: arbitrary unit No. 3;
* INR: International Normalized Ratio;
* Ref.: time of the reference plasma.
Convers. Factor Conversion coefficient between the primary
unit and the secondary unit concerned, if
applicable.

Print For the primary unit or for the secondary units,

there are two options for printing out:
* YES: unit utilized;
* NO: unit not utilized.

Transmission For transmission of primary or secondary

Test Number units, the test number corresponding to the
host computer should be given if the unit is
used. If the unit is not used, the rank is set to 0
(F1 key).

3.1.3.2. Usual Value Definition

Min. Max. Definition of the usual value range as a

function of the primary unit in which the
results are expressed.

3.1.3.3. Printout Limit Definition

Printout Limits Range of acceptable values in primary units

for reporting results.Each out of range result
min.max. is reported either as the minimum value or as
the maximum value (with an alarm code).

3-16 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.1.3.4. Quality Control Definition

One to three controls must be defined to be integrated in the quality control files: Level 1,
Level2 and Level 3

I.D Alphanumeric identification for each of the

(8 characters) three controls.

Key Just for Diagnostica Stago products,allows to

choose, in a list corresponding to the order of
parameters printed on the bar code labels,
the test or the reagent concerned.

Name Complete name of each of the three controls.

(6 to 15 characters)

Period Definition of the period of each control (in

hours).
Minimum: 1 hour;
Maximum: 24 hours.

Vial Initial control volume in the vial (in millilitres).

Stab.h Stability of each control (in hours).Stability is

checked after loading.

Min. Volume The volume of remaining control at which the

®
ml STA Compact will not run another quality
control.

3.1.4. Dependent Tests

From each main test, 8 dependent tests can be created which differ from the main test only
with respect to plasma dilution, corrector factor and transmission test number.

For measurement, all dependent tests use the same parameters as their main test except
dilution.

For calculation of results, the dependent tests use the same calibrations as the main test and
their own corrector factor.

For transmission of results, the dependent tests used their own transmission test
numbers.For instance, dependent tests can be used for determination of factor levels at
several dilutions.

Fig.8– Dependent Tests Screen

V 1.0 - November 96 3-17

Test Setup STA COMPACT  OPERATOR’S MANUAL

➊ Available function list:

↵ Access to zone 4 (see above) to create or modify a dependent test;

Esc displays the EXIT OPTIONS window (see description chapter 3.3.2. of the STA
®
Compact Operator’s Manual ).

➋ Dependent test list

➌ Reminder of some parameters of the main test

➍ Definition of the parameters of each dependent test

Abbreviation Abbreviation of the dependent test.

(8 characters)

Name Complete name of the dependent test.

(25 characters)

Dilution Choice of dilution for dependent

test.There are the following options:
- 1/1 - 1/20
- 1/2 - 1/30
- 1/3 - 1/40
- 1/4 - 1/50
- 1/5 - 1/60
- 1/6 - 1/80
- 1/7 - 1/100
- 1/8 - 1/160
- 1/10 - 1/200
- 1/12 - 1/400
- 1/15

Corrector Systematic multiplication factor for all

reported results of dependent tests
(excluding raw data).

Units Reminder of the main and secondary

units used for the dependent test and the
main test.

Transmission Test Number For the use of primary or secondary units

for transmission, the transmission test
numbers corresponding to the host
computer should be given if the unit is
used. If the unit is not used, the rank is
set to 0 (F1key).

3-18 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.2. Access to the Test Setup Parameters

3.2.1. Access to the Test Setup Menu

START: Test Panel displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status- Loading (...) - Halt

with the cursor positioned on Status.

Press the E key. The sub-menu is displayed:

Or press the → key 4 times, to move Tests

the cursor to Setup, then press the ↵ Global Options
key.
with the cursor on Tests.

If measurements are in process, you The TEST SETUP screen is displayed

can only view the test setups;then with the cursor on the first test .
press the ↵ key.
There is a yellow point in front of the
dependent test abbreviation.

If the operator views a test setup, the

following message “Reading in
process-Modification not allowed-
Space Bar: washing window” is
displayed at the foot of the screen.

®
If the STA COMPACT is in stand-by, The TEST SETUP screen is displayed
you can create test setups. To modify with the cursor on the first test.
some test setups, it is also necessary
that: There is a yellow point in front of the
* the tests concerned are not present dependent test abbreviation.
in any patient files of the working file,

* the access code is known.If not, you

can only view them.

Press the ↵ key.

V 1.0 - November 96 3-19

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.2.2. Description of the TEST SETUP Screen

Fig. 9Test Setup Screen

➊ Available function list:

↵ Access to the first TEST SETUP screen for the test on which the cursor is
positioned;

Esc displays this window:

Displace Test

Delete Test

Update

Quit

For the options: Displace Test, Delete Test, Update, please see description in
®
chapters 3.5., 3.6., and 3.7. of the STA Compact Operator’s Manual.

Please note: If measurements are in process, the available functions are:

Esc Return to TEST PANEL screen;

↵ View a test setup.

➋ Title of the screen

➌ Complete name corresponding to the cursor position. For each Dependent Test: name of the
main test it is derived from

➍ Available test list. There is a yellow point in front of the dependent test abbreviation

3-20 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.2.3. Access to the Screens of the Main Test Setup

START: TEST SETUP screen displayed with the cursor on the first test (see chapter 3.2.1.
®
of the STA Compact Operator’s Manual).

ACTIONS RESULTS

Press the↓ or the → key. Cursor moving.

Press the ↓ key to the required main Cursor on the required test.
test (without yellow point).

Confirm the choice with the ↵ key. Page 1 of 3 of the test setup displayed,
with the cursor on the first modifiable
setup parameter.

Press the PgDn key. Page 2 of 3 of the test setup displayed

with the cursor on the first modifiable
setup parameter.

Press the PgDn key. Page 3 of 3 of the test setup displayed,

with the cursor on the first modifiable
setup parameter.

Press the PgUp key twice. Return to page 1 of 3 of the test setup.

Press the Esc key. The EXIT OPTIONS window is

displayed:

EXIT OPTIONS

Save before Quitting

Quit without Saving
Do not Quit

Press the Q key. Confirmation of the exit without saving.

Or press the ↓ key, then confirm with Return to the TEST SETUP screen.
the ↵ key.
Caution! For the option Save
before Quitting (↵ key), the
user should know the
access code (see
validation procedure,
chapter 3.3.2. of the STA
®
Compact Operator’s
Manual).
Note: If the Esc key is pressed by mistake, press it again in order to cancel the
instruction toexit from the setup screens.

3.2.4. Access to the Dependent Test Setup Screen

3.2.4.1. Access to the Dependent Test Setup Screen from the TEST SETUP Screen

Reminder: There is a yellow point in front of the dependent test abbreviation.

V 1.0 - November 96 3-21

Test Setup STA COMPACT  OPERATOR’S MANUAL

START : TEST SETUP screen displayed, with the cursor on the first test (see
®
chapter 3.2.1. of the STA Compact Operator’s Manual).

ACTIONS RESULTS

Press the ↓ or the → key to reach the The cursor is on the required test
required test (with a yellow point).

Confirm the choice with the ↵ key. The screen of the dependent test setup
is displayed with the cursor on the
required dependent test of the
dependent test list side (see the
description of this screen chapter 3.1.4.
®
of the STA Compact Operator’s
Manual).

Confirm the choice with the ↵ key. Cursor on the first modifiable parameter
of the dependent test setup.

3.4.2.2. Access to the Dependent Test Setup Screen from the Required Main Test Setup

Reminder : This access is available only from page 1 of 3 of the main test setup.

START : Page 1 of 3 of the main test setup screen displayed

ACTIONS RESULTS

Press the F4 key. The DEPENDENT TESTS screen is

displayed with the cursor on the first
dependent test of the dependent test
list side (see the description of this
screen in chapter 3.1.4. of the STA
®
CompacT Operator’s Manual).

Press the ↓ key to the required Cursor on the first modifiable parameter
dependent test, then confirm with the of the dependent test setup.
↵ key or just confirm by pressing the ↵
key.

3.2.5. Access to Setup Parameters

START: A setup screen is displayed, the cursor is on the first parameter

Procedure for moving the cursor:

KEYS RESULTS

↓ Moves cursor to next line.

↑ Moves cursor to preceding line.

←,→ Moves cursor into entry field of parameter

concerned.

Tab Moves cursor to the next modifiable parameter.

Shift and Tab Moves cursor to the previous modifiable parameter.

↵ (Enter) Moves cursor from one parameter to the next.

3-22 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.3. Modifying a Setup Parameter

☞
®
Caution! Please, see chapter 1.8.3. of the STA Compact Operator’s Manual.

This procedure is only possible if:

−
®
the STA Compact is in stand-by (no measurement in process);
− the operator knows the access code.
Moreover, for some parameters, this procedure requires that none of the
concerned tests are present in the Patient files of the Working File.

Modifying certain parameters may have very important consequences:

− invalidation of calibration;
− deletion of quality controls.
®
(see description of validation procedure, chapter 3.3.2. of the STA Compact
Operator’s Manual).

Note : The fields displayed in grey are not modifiable, only the fields displayed in blue or
white are modifiable.

With the cursor positioned on the required parameter, there are two options:

1) Free entry field*. In this case no message is displayed at the foot of the screen. The
data and the cursor are displayed in blue;

2) Multiple-option field*. In this case, the message “Delete key to modify this field” is
displayed at the foot of the screen. The data and the cursor are displayed in white.

3.3.1. Modification Procedure

* Free entry field Enter the new information on the

alphanumeric keyboard. Confirm with the ↵
key. "

* Multiple-option field There are two options:

∗ Two possible choices: The Delete key
moves from one option to another.
Confirm the selection with the ↵ key;

∗ Multiple possible choices: The Delete

key allows to open a selection
window.Press the ↓ or → key to move
the cursor to the required selection and
validate with the ↵ key
3.3.2. Validation Procedure

START : One of the setup screens is displayed and all modifications have been made.

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

EXIT OPTIONS

Save before Quitting

Quit without Saving
Do not Quit

With the cursor on Save before quitting.

V 1.0 - November 96 3-23

Test Setup STA COMPACT  OPERATOR’S MANUAL

ACTIONS RESULTS

Press the ↵ key to confirm. The software checks the consistency of (and
between) the different parameters.

If an inconsistency is revealed [for instance,

total volume (sample + reagents) is higher
than 400 µl]:
* the error window is displayed giving
the number of the setup page
concerned by the inconsistency and a
description of this latter;

ERROR - Page 1

Sample + Reagents volume

Out of range [150......400] Úl

Esc: Cancel this message

* the software displays automatically

the concerned setup page.

Read carefully the displayed The cursor is automatically positioned on the

message, then press the Esc key. parameter to be modified.

Proceed with the modification(s) The software checks the consistency once
then press the Esc key once again. again.

If no inconsistency is revealed, the following

window is displayed:

Please enter
your access code:

↵ Validate Esc Quit

Enter your access code, then The software checks if critical parameters
confirm with the ↵ key. have been modified (for example, incubation
times, reagent volumes).

In this case, to alert the user of the

consequences of his modification(s), the
following window is displayed:

IMPORTANT CHANGES DETECTED

THE FOLLOWING ACTIONS WILL BE TAKEN:

Calibration ...
Quality Control

Please type YES to accept

Esc: Abort

with different statements depending on the

parameters modified:
*Calibration: invalidate (the user must rerun the
calibration of the test concerned);
*Quality Control: Delete (for all Quality Control
levels, the results will be deleted);

3-24 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

ACTIONS RESULTS

If no critical parameter has been modified:

* test setup is saved;
* then, return to the TEST SETUP screen.

In case of modification of critical Depending on modifications:

parameters, if the consequences * Invalidation of calibration for test
are accepted, type YES, then concerned;
confirm with the ↵ key. * Deletion of Quality Control results for test
concerned.

Then, test setup is saved.

And return to the TEST SETUP screen.

From the TEST SETUP screen, A message advising the operator to proceed
press the Esc key then confirm with the saving of the test configurations is
with the ↵ key. displayed.

Press the ESC key. Return to the TEST PANEL.

Proceed with the saving of the

test configurations (see chapter
®
9.7.5. of this STA Compact
Operator’s Manual).

V 1.0 - November 96 3-25

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.4. Creation of a New Test

☞
®
Caution! Please, see chapter 1.8.3. of the STA Compact Operator’s Manual.

This procedure is only possible if:

®
- the STA Compact is in stand-by (no measurement in process),
- the operator knows the access code.
Reminder : For the description of the test setup parameters (see chapter 3.1. of the STA
®
Compact Operator’s Manual).

3.4.1. Main Test Creation

−
®
access the Test Setup menu (see chapter 3.2.1. of the STA Compact Operator’s
Manual);
− move the cursor with the End key to the empty space after the last test in the
available test list;
− press the ↵ key;
− in the case of free entry fields: enter the new information for each parameter (see
®
chapter 3.3.1. of the STA Compact Operator’s Manual);
− in the case of Multiple-Option fields, use the Delete key (see chapter 3.3.1. of the STA
®
Compact Operator’s Manual);
− when the 3 pages of the test setup have been revised, validate the test setup (see
®
chapter 3.3.2. of the STA Compact Operator’s Manual).
3.4.2. Dependent Test Creation
−
®
access the Test Setup menu (see chapter 3.2.1. of the STA Compact Operator’s
Manual);
− move the cursor to the main test from which the dependent test will come;
− press the ↵ key;
− Then, press the F4 key;
− move the cursor with the ↓ key to the empty space after the last test of the
dependent test list;
− press the ↵ key;
− in the case of free entry fields: enter the new information for each parameter (see
®
chapter 3.3.1. of the STA Compact Operator’s Manual);
− in the case of Multiple-Option fields, use the Delete key (see chapter 3.3.1. of the STA
®
Compact Operator’s Manual);
− when all parameters are defined, press the F10 key, then press the Esc key and the
↵ key (Save before Quitting), then enter your access code and confirm with the ↵key:
return to the Main Test;
− press the Esc key, then the Q key: return to the TEST SETUP screen.
☞ Caution ! it is not necessary and even not recommended to save the main test since the
system will reject this request if there are still Patient files containing this main
test in the Working File.

3-26 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.5. Test Order on the TEST PANEL Screen

Each laboratory can choose the position of the tests on the TEST PANEL screen and on the
different screens where tests are listed. This procedure is executed from the Test Setup
menu.

☞
®
Caution This procedure is only possible if the STA Compact is in stand-by (no
measurement in process).

START : The TEST SETUP screen is displayed, with the cursor on the first test (see
®
chapter3.2.1. of the STA Compact Operator’s Manual)

ACTIONS RESULTS

Press the Esc key. The following window appears:

Displace Test
Delete Test
Update

Quit

with the cursor on Quit.

Press the D key. The following window appears:

Or move the cursor to Displace Test TEST DISPLACEMENT

with the ↓ key, then confirm with the ↵
key. ↵ : Select test to be moved
Esc : Quit

With the cursor on the first test.

Press the ↓ key to the test which has The following window appears:
to be moved then confirm by pressing
the ↵ key. Move cursor to the new position
↵ Insert
Esc Quit

with the yellow cursor on the test to be

moved.

Press the ↑ or the ↓ keys to move the The test order is automatically
yellow cursor to the required place, reorganized.
then confirm with the ↵ key.

Same procedure as above to move The test order is automatically

the other tests, then exit this reorganized, then return to the TEST
procedure by pressing the Esc key. SETUP screen.

V 1.0 - November 96 3-27

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.6. Test Deletion

Note : This procedure is only possible:

− for the tests defined by the operator (the tests predefined by Diagnostica Stago
are not erasable);
− if STA Compact is in stand-by (no measurement in process);
®

− if none of the concerned tests are present in the Patient Files of the Working
File;
− if the operator knows the access code.
Note : If the test deleted is a main test, then all tests dependent from this test will be also
deleted.

START : The TEST SETUP screen is displayed, with the cursor on the first test of the
®
list, (see chapter 3.2.1. of the STA Compact Operator’s Manual).

ACTIONS RESULTS

Press the ↓ key to reach the test

which has to be deleted (main test or
dependent test).

Press the Esc key. The following window appears:

Displace Test
Delete Test
Update
Quit

with the cursor on Quit.

Press the ↓ key to Delete Test, then The following window appears:
confirm with the ↵ key.
TEST DELETION

Abbrev. XXX
Name XXX
WARNING:
All dependent tests will be deleted if
the deleted test is a main test
Please type
YES to confirm ...
Esc Quit

with the yellow cursor positioned for the

confirmation

Type YES, then confirm with the ↵ The following window appears:
key.
Please enter
your access code:

↵ Validate Esc Quit

3-28 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

ACTIONS RESULTS

Type your access code, then confirm The following window appears:
with the ↵ key.
TEST DELETION

Abbrev. XXX
Name XXX
DELETING...
Please wait ... ...

When the deletion is done:Return to the

TEST SETUP screen automatically.

Caution! If you try to delete a test

which is in process, the following
window appears:

TEST DELETION

Abbrev. XXX
Name XXX
Test used in Working File
CANNOT DELETE

Esc Cancel this message

Press the Esc key to delete this last The TEST SETUP screen appears.
message.

V 1.0 - November 96 3-29

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.7. Test Updating

Note : The procedure allows to update or create tests predefined by Diagnostica Stago.
This procedure is only possible if :
− the STA Compact is in stand-by (no measurement in process);
®

− no test is present in the Patient Files of the Working File;

− the access code is known.
If tests have to be added, there should be enough empty positions, otherwise the operator
will be asked to delete the number of required tests.

☞ Caution The test update may have very important consequences:

− all dependent tests from an updated main test will be deleted;
− invalidation of calibration (depending on the modified parameters);
− Deletion of quality controls (depending on the modified parameters).
START : The TEST SETUP screen is displayed with the cursor on the first test of the test list
®
(see chapter 3.2.1. of the STA Compact Operator’s Manual ).

ACTIONS RESULTS

Press the Esc key. The following window appears:

Displace Test
Delete Test
Update

Quit

with the cursor on Quit

Press the U key. The UPDATE TRACK RECORD

screen appears with the following
Or move the cursor to Update, then window:
confirm with the ↵ key.
OPTIONS

Update
Quit

with the cursor on Quit.

The list of tests modified by previous

updates or creations appears in blue
with the modification dates.

Press the U key. The following window appears:

Or move the cursor to Update, then Please enter

confirm with the ↵ key. your access code:

↵ Validate: Esc Qui

Enter your access code then confirm The following window appears:
with ↵ key.
Please insert the diskette
TESTS UPDATE
in the floppy drive

↵ Confirm Esc Quit

3-30 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

ACTIONS RESULTS
Caution! If there are still Patient Files in the
Working File, the following window
appears:

TEST UPDATING

WORKING FILE NOT EMPTY

Updating not completed

Erase Working File

Abort

with cursor positioned on Abort.

The Working File may be erased by pressing
the ↓ and ↵ keys, then by confirming with
YES and ↵.
Insert the diskette in the floppy drive, The following window appears:
then confirm with the ↵ key.
File reading
Please wait ... ...

Then, the TEST UPDATING screen

appears. The list of tests which are going to
be updated or created is displayed in
blue.The number of tests to be added are
also displayed, as well as the number of
positions currently occupied, the number of
available positions.

Press the F10 key. The following window appears:

Test updating
Please wait ...

On the TEST UPDATING screen, the test

display change from blue to yellow during
the updating.

Then, the window changes into:

Update done
Esc Quit

Press the Esc key The UPDATE TRACK RECORD screen

appears. The tests previously updated or
created are displayed in blue, those
currently updated or created in yellow.

The following window appears:

OPTIONS

Update
Quit

With the cursor positioned on Quit.

Press the ↵ key. Return to the TEST SETUP screen

V 1.0 - November 96 3-31

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.8. Calculated Tests

3.8.1. Introduction

The calculated tests are tests for which the result is a calculation expression using one of
this 2 formulae:
(R1/R2) x k

or (R1-R2) x k

with R1, R2: Results not limited to the printout limits expressed as raw data (sec.,
∆O.D., O.D./min) for test [1] and test [2] chosen by the operator.

k: Programmable coefficient.

Thus, one result can be given either as equal to a ratio between two tests or as equal to a
difference.

The unit in which the result is given is implicit; i.e.: Ratio for a ratio calculation and raw data
for a difference calculation. The secondary units have not to be defined for calculated tests.

This type of calculation is authorized only when test [1] and test [2] are based on the same
type of measurement method: i.e.: clot-based, chromogenic or immunology.

Calculated tests as well as dependent tests can not be used as test [1] or test [2].

Results from calculated tests are given only when those for test [1] and test [2] have as
status “To Confirm”, “Confirm”, “Dev.> tol.” or “V > V max.” (equivalent to T > T max.), see
®
description of these statuses, chapter 6.3.2. and 6.3.3. of the STA COMPACT Operator’s
Manual.

Moreover, they can not be confirmed manually: their confirmation implicitly follows from
those of test [1] and test [2]. Results from calculated tests have as error code and as alarm
code, the most serious error code and the most serious alarm code among those assigned
to test [1] and test [2]. Only alarm code H (result in primary unit limited to printout limit
values) escapes this rule because it directly applies to the values obtained for the calculated
®
results, see below chapter 3.8.2. of the STA COMPACT Operator’s Manual.

Because of their particularity, calculated test can not be rerun, it exists neither calibration nor
quality control for this type of test and those can not have any dependent test.

The procedures to access, to modify and to create these tests are identical to those
®
described for the other types of test, see chapters 3.2. , 3.3. , 3.4. of the STA COMPACT
Operator’s Manual.

3-32 V 1.0 - November 96

STA COMPACT  OPERATOR’S MANUAL Test Setup

3.8.2. Description of the Definition Parameters for a Calculated Test

Fig. 10 –Calculed Test Parameters

➊ ESC displays the EXIT OPTIONS window (see description, chapter 3.3.2. of the STA
®
Compact Operator’s Manual).

➋
®
Test Identification Section, see description, chapter 3.1.1. of the STA Compact Operator’s
Manual.

➌ Definition of test [1] and test [2].

➍ Definition of parameters for Printout/Transmission.

➎ Definition of calculation formula.

➏
®
Definition of the printout limits, see description, chapter 3.1.3.3. of the STA Compact
Operator’s Manual.

3.8.3. Definition of Test [1] and Test [2]

Abbreviation Abbreviations for test [1] and test [2] to be

selected in the list of tests currently
®
available on STA Compact .
Reminder: Test [1] and test [2] must be
of the same type: clot-based,
chromogenic or immunological.

Name Names of test [1] and test [2]. They are

automatically displayed after selection of
the abbreviations.

V 1.0 - November 96 3-33

Test Setup STA COMPACT  OPERATOR’S MANUAL

3.8.4. Printout / Transmission Section

Reminder: The unit is implicit with relation to the type of calculation selected, see chapter
®
3.8.1. of the STA Compact Operator’s Manual.

Printout Utilization of the unit for printout, two

possible choices:

* YES: Unit utilized;

* NO: Unit not utilized.

Trans.: Test Number To be able to transmit the result of the

calculated test, the transmission test
number corresponding to the host
computer has to be defined. If the test has
not to be transmitted, rank has to be set to
0 (F1 key).

3.8.5. Definition of Calculation Formula

Formula Choice between two types of formula:

* (Result 1/ Result 2) x k
* (Result 1 – Result 2) x k

Reminder: Result 1 and result 2 are

expressed in raw data (sec.,
∆O.D., O.D./min.).
Constant k Coefficient programmable between 0.001
and 9999.999.

3-34 V 1.0 - November 96

STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 4

4. LOADING OF PRODUCTS AND SAMPLES 1

4.1. Generalities 1

4.2. Access to the Loading Menu 2

4.3. Description of PRODUCT LOADING Screen 4

4.4. Description of the SAMPLE LOADING Screen 5

4.5. Identification and Loading of Reagents/Desorb Solutions

(Product Drawer) 7
4.5.1. Bar Code Identification of Reagents/Desorb Solutions and Loading
(Product Drawer) 7
4.5.2. Manual Identification of Reagents/Desorb Solutions and Loading
(Product Drawer) 9

4.6. Identification and Loading of Controls/Calibrators

(Product Drawer) 11
4.6.1. Bar Code Identification of Controls/Calibrators and Loading (Product Drawer) 11
4.6.2. Manual Identification of Controls/Calibrators and Loading (Product Drawer) 13

4.7. Identification and Loading of Diluents (Sample Drawer) 15

4.7.1. Description of the Entry Zone for a Diluent 15
4.7.2. Bar Code Identification of Diluents and Loading (Sample Drawer) 15
4.7.3. Manual Identification of Diluents and Loading (Sample Drawer) 16

4.8. Sample Identification and Loading (Sample Drawer) 18

4.8.1. Introduction to Sample Identification and Test Selection 18
4.8.2. Definition of a Prefix 18
4.8.3. Definition of a Test Profile 19
4.8.3.1. Create a Test Profile 20
4.8.3.2. Modify a Profile 21
4.8.4. Sample Type 22
4.8.4.1. Generalities on Sample Type 22
4.8.4.2. Sample Type Definition 22
4.8.5. MANUAL Mode 23
4.8.5.1. Access to MANUAL Mode 23
4.8.5.2. Selecting a Prefix 23
4.8.5.3. Bar Code Identification of Samples and Tube Loading 24
4.8.5.4. Manual Identification of Samples and Tube Loading 25
4.8.5.5. Auto-incrementation of Sample Identification and Tube Loading 25
4.8.5.6. Individual Selection of Test 26
4.8.5.7. Selecting Tests by Profiles 26
4.8.5.8. Teleloading Tests from Host Computer 27

V 1.0 - January 96
Table of Contents, Chapter 4 STA COMPACT ® OPERATOR'S MANUAL

4.8.6. AUTOMATIC Mode 28

4.8.6.1. Access the AUTO Mode 29
4.8.6.2. Definitions of the Prefix and of the First Number for the AUTO Mode 29
4.8.6.3. Use of AUTO Mode 30
4.8.7. Sample Loading with Automatic Display of the List of Tests 31

4.9. Modification on Loaded Products or Samples 32

4.9.1. Modification Procedure for the Product Drawer 32
4.9.2. Modification Procedure for the Sample Drawer 33

4.10. Unloading of Samples or Products 35

4.10.1. Unloading with Positive Identification 35
4.10.2. Unloading without Positive Identification 35

4.11. Loading without Positive Identification 37

4.11.1. Sample Drawer Procedure 37
4.11.2. Product Drawer Procedure 38

4.12. Running Tests (Closing of Sample or Product Drawer) 39

V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4. LOADING OF PRODUCTS AND SAMPLES

4.1. Generalities

The samples and the various products (controls, calibrators, diluents, reagents, desorb
solutions) can be loaded, whether in the sample drawer or in the product drawer, see table below:

Loading is possible in:

Sample Drawer Product Drawer

Controls NO YES

Calibrators NO YES

Diluents YES NO

Reagents NO YES

Desorb Solutions NO YES

Samples YES NO

☞ Caution ! Before any loading, the following points have to be checked:

– for reagents or any other products (controls, standards, diluents and desorb
solutions), check for foam on surface. If foam has formed, eliminate it;
– for samples, use only tubes after centrifugation, check that the plasma
quantity is adequate and that no foam, no clot or no micro-clot is present.

For all loading and unloading operations, the proper precautions for handling
biohazardous materials should be observed in accordance with local existing
regulations: mainly use disposable gloves and incinerate waste materials as
recommended in most countries.

For all loading operations, to avoid confusion, handle only one tube or vial at once.

For all products (reagents, controls, calibrators, dilution buffers, desorb solutions),
please read carefully all the instructions provided in the package insert of each
related product kit and observe all the procedures described.

To comply with the requests of the package inserts related to the intrinsic
coagulation pathway deficient plasmas (VIII, IX, XI, XII) as well as the one
related to the reagent STA-Staclot ® Protein S, i.e.: “The factor assays of the
patients samples follow the completion of assay calibration and are performed
within the time-frame that is compatible with the stability of related factor in
plasma”, the following procedure will be observed:

– before to start loading samples, block the required test (example: factor VIII), see
procedure, chapter 6.7.3. of the STA Compact ® Operator’s Manual;
– run calibration for the required test (example: factor VIII);
– change to STAT (F12 key), any sample tube with the required test (example:
factor VIII) in its working list: whether, while loading (see procedure, chapter 4.8.4.
of the STA Compact ® Operator’s Manual) or while processing Patient files (see
procedure, chapter 6.3. of the STA Compact ® Operator’s Manual);
– as soon as calibration of the required test (example: factor VIII) is validated,
unblock this latter (example: factor VIII), see procedure, chapter 6.7.3. of the STA
Compact ® Operator’s Manual.

V 1.0 - November 96 4-1

Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.2. Access to the Loading Menu

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading - (...) - Halt

Press the L key (Loading). The sub-menu is displayed:

Samples F1
Products F2
Cuvettes
Washing Solution

with the cursor on Samples.

For the Sample Drawer, press the ↵ key. 2 possible cases:

For the Reagent Drawer, press the P key. * STA Compact® is p ip e t t in g i n t he

selected drawer or needs the drawer
(mainly the product drawer for the
cuvettes still in incubation); the message
“X d r a w e r : O p e n i ng re q u e s t ed”
appears at the foot of the TEST PANEL
screen (X= the number of the drawer).

Caution! In case of the product drawer,

the STA Compact® will stop pipetting
samples; it needs about 5 minutes to
complete the pending tests.

As soon as the STA Compact® can

l i b e r a t e t he s e le c t e d d r a w e r , a
confirmation message is displayed on the
screen. The operator must confirm his
request for opening. Thus, the message
“DRAWER OPENING” is displayed at the
foot of the screen.

* STA Compact® can immediately open

the drawer, the message “DRAWER
OPENING” is displayed at the foot of the
TEST PANEL screen.

Drawer opens automatically.

Bar code reader is switched on and beeps.

The window: “Searching...” is displayed.

For the sample drawer, the SAMPLE

LOADING screen is displayed (see
description, chapter 4.4. of the STA
Compact ® Operator’s Manual).

For the product drawer, the PRODUCT

LOADING screen is displayed (see
description, chapter 4.3. of the STA
Compact ® Operator’s Manual).

4-2 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

☞ Caution! While a drawer is open, do not insert the hand or any other object inside the STA
Compact ®.

Reminder: If the liquid level detection management has been inhibited for one or several
needles, a warning message will be displayed upon opening of the related
drawer (sample drawer for needle No.1, reagent dawer for the 3 needles).

For the sample drawer, all tubes should be decanted and the operator
must insure that the plasma quantity is sufficient to perform the request
assays.

For the product drawer, the theoretical bottle filling volumes as defined while
loading shall be consistent with the actual ones.

V 1.0 - January 96 4-3

Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.3. Description of PRODUCT LOADING Screen

Fig. 1 - PRODUCT LOADING Screen

➊ Name of the screen, current Date and Time

➋ Available keys:

Esc Returns to the TEST STATUS screen.

↑ List/Change: this key accesses to these function keys :
↵ Allows product modifications (see chapter 4.9.1. of the STA Compact ®
Operator’s Manual).
After the drawer is closed, nothing can be modified.
Del Allows removal of a product from the drawer
Esc Returns to the REAGENT LOADING

➌ Identification number for each product. It is displayed in red when the stability is overdue, when
the minimum volume is reached or when a liquid level detection problem is detected.

➍ Name of each product

➎ Remaining volume of each product.It is displayed in red when the minimum volume is reached
or when a liquid level detection problem is detected.

➏ Stability for each product.

➐ Lot number of each product

➑ Position of each product in the product drawer. The sign µ is displayed at the right side of the
position for products transferred into the microcontainers.

➒ Date and Time of the end of stability for each product. It concerns stability defined within the
Test Setup menu (see chapter 3.1. of the STA Compact ® Operator’s Manual). It is displayed
in red when the given time is within the period: stability end minus 1h and stability end. It is
replaced by the word Complete displayed in red when the stability end is reached.

➓ Upper zone = products already loaded

Entry zone for product to be loaded

➒ Indication Normal Vol./Microvolume according to the selected choice (F8 key)

4-4 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.4. Description of the SAMPLE LOADING Screen

Fig. 2 - SAMPLE LOADING Screen: MANUAL Mode

Fig. 3 - SAMPLE LOADING Screen: AUTO Mode

➊ Name of the screen

➋ Available keys:

Esc Options : this key opens the following windows:

*for MANUAL Mode: * for AUTO Mode:

Change Profiles Change Profile

Change Prefix Change Prefix/First Number
AUTO Mode MANUAL Mode

Return to Loading Return to Loading

Quit Quit

V 1.0 - January 96 4-5

Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

* Change profile(s): Creates or modifies Test Profiles (see description in chapter 4.8.3.
of the STA Compact ® Operator’s Manual).

* Change Prefix (MANUAL Mode) or Change Prefix/First Number (AUTO Mode):

- For MANUAL Mode, modifies the prefix selected by default (see chapter 4.8.5.2.
of the STA Compact ® Operator’s Manual);

- For AUTO Mode, modifies the prefix and the first number (see description in
chapter 4.8.6.2. of the STA Compact ® Operator’s Manual).

* AUTO mode: Accesses the AUTO Mode.

* MANUAL mode: Accesses the MANUAL mode.

* Return to Loading: Returns to SAMPLE LOADING with the cursor on zone of the
SAMPLE LOADING screen (see below).

* Quit: Closes the sample drawer and displays the TEST STATUS screen.

↑ List/Change : This key allows access to the following function keys :

*↵ Modifies several parameters; after closing, no more modification will be

possible;
* Del Deletes a Patient tube or a diluent from the Sample Drawer;
* Esc Returns to the SAMPLE LOADING screen.

➌ Identification of the current mode (AUTO or MANUAL mode).

➍ Selected prefix.

➎ Recall of the last six loadings.

➏ Identification (numeric or alphanumeric) of each sample or diluent. A colored code distinguishes

the different status:

– white: nothing to declare;

– yellow: STAT Sample;
– grey: Patient File without known working list (waiting for teleloading from the Host
Computer);
– green: Liquid Level Detection problem;
– red: Patient File for which one or several tests have errors; or diluent with low volume
or overdue stability.

➐ Position of each sample or diluent in the sample drawer. The sign µ is displayed at the right of
the position of samples which have been transferred into microcontainers.

➑ List of tests requested for each sample. For the diluents name as defined within the TEST SETUP
screens (see chapter 3.1. of the STA Compact ® Operator’s Manual).

➒ List of User defined profiles (MANUAL Mode).

➓ Test selection list (MANUAL Mode).

Field for entering data concerning the sample which has to be loaded. In the ID field is displayed
the Normal tube or Microtube indication in blue for non-urgent samples and in yellow for STAT
samples.

Selected parameters for AUTO Mode: test profile, prefix and first number

4-6 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.5. Identification and Loading of Reagents/Desorb Solutions

(Product Drawer)

For identification of reagents/desorb solutions, there are two options:

– Automatic identification using bar codes.
– Manual identification using the keyboard.

Note: In case of lot number change, the calibrations related to these reagents will no be longer
valid.

When a stabilization period in STA Compact ® instrument is required for some reagents,
it is necessary to block the tests using these reagents before to load them.
See the package inserts of each reagent kit and see blocking procedure, chapter 6.7.3.
of the STA Compact ® Operator’s Manual.

4.5.1. Bar Code Identification of Reagents/Desorb Solutions and Loading (Product Drawer)

START: PRODUCT LOADING s c r e e n d i s p l aye d w i t h m e s s a g e “PRODUCT

IDENTIFICATION (F8 = Normal Vol./Microvolume)” at the foot of the screen and
Normal Vol. displayed in area (see description of PRODUCT LOADING screen,
chapter 4.3. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

If the reagent/desorb solution is in its

original vial, skip the ACTIONS box below.

If the reagent has been transferred into a The mention Normal Vol. changes into
microcontainer, press the F8 key. Microvolume (area , see description of
PRODUCT LOADING screen, chapter 4.3.
of the STA Compact ® Operator’s Manual).

Scan the bar code label of the Identification (ID), name (Name), volume
reagent/desorb solution vial across the bar (Volume), stability (Stab.), and lot number
code reader. (Lot) of the reagent/desorb solution are
displayed.

In case of failure of the Bar Code Reader, The cursor is positioned on the Volume
proceed as indicated below, see chapter field for correction if any.
4.5.2. of the STA Compact ® Operator’s
Manual.

The message “INDICATE THE VOLUME

(in ml) - Esc = Correction” is displayed at
the foot of the screen.

If it is necessary to modify the volume, The new volume is displayed.

type the new value, then confirm with the
↵ key.

Otherwise, confirm directly with the ↵ key The cursor is positioned on the Stability
and skip to the RESULTS box below. field.

The message “INDICATE THE

STABILITY (hours) - Esc = Correction”
is displayed at the foot of the screen.

Modify the stability if necessary, then The volume and the stability are displayed.
confirm with the ↵ key.

Otherwise, confirm directly with the ↵ key. The message “LOAD THE LAST
IDENTIFIED VIAL - Esc = correction” is
displayed at the foot of the screen.

V 1.0 - January 96 4-7

Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Position the vial in a position On the product drawer:

corresponding to its diameter while The LED adjacent to the vial position lights
considering the positions with mixing or up and the machine beeps: position and
without. identification validated.
Note: If the vial is not properly positioned, On the screen:
the operator will be informed by an Automatic display of the position (Pos.).
error message.
If no lot change is detected, jump over the
two RESULTS boxes below.

If a lot change is detected, the following

window is displayed:

LOT NUMBER CHANGED

All related calibrations
will be definitively invalid

Accept (YES/NO) XXX

If the Lot number change is accepted, The following window is displayed:

enter YES then confirm with the ↵ key.

Please scan the code sheet

in front of the reader

Esc: Quit

Scan the bar code sheet in front of the For non-precalibrated reagent, skip to
reader. next RESULTS box.
Note! In case of failure of the Bar Code For precalibrated reagents, the 2 following
reader, type the information windows appear one after another if
printed below the bar codes and necessary:
confirm each line with the ↵ key.

BAR CODE READING

End of Data Processing

BAR CODE READING

Data Read
A0 xxx
A1 xxx
A2 xxx
A3 xxx
N xxx
ISI xxx

Esc = Cancel this message

4-8 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

ACTIONS RESULTS

Press the Esc key. Data for this reagent/desorb solution

transferred to the top part of the screen
(zone ➓, see description on chapter 4.3. of
the STA Compact ® Operator’s Manual).

Follow the same procedure for the next

vial of reagent/desorb solution.

4.5.2. Manual Identification of Reagents/Desorb Solutions and Loading (Product Drawer)

START: PRODUCT LOADING s c r e en d is p layed w it h m e s s a g e “PRODUCT

ACTIONS RESULTS

If the reagent/desorb solution is in its original

vial, skip the ACTIONS box below.

Enter the identification of the The reagent/desorb solution identification is

reagent/desorb solution as defined in the displayed.
Test Setup on page 1 of 3 and confirm
with the ↵ key.

The cursor is on the Name field.

Type the name of the reagent/desorb The name of the reagent/desorb solution
solution as defined in the Test Setup page is displayed.
1 of 3, then confirm with the ↵ key.
The cursor is on the Volume field.

The message “INDICATE THE VOLUME

(in ml) Esc =Correction” is displayed at
the foot of the screen.

Enter the reagent/desorb solution volume The volume is displayed.

and confirm with the ↵ key.
The cursor is on the Stab. field.

The message" INDICATE THE

STABILITY (hours) - Esc = Correction"
is displayed at the foot of the screen.

Type the stability, then confirm with the ↵ The stability is displayed.
key.
The cursor is on the Lot field.

The message" INDICATE THE LOT

NUMBER - Esc = Correction" is
displayed at the foot of the screen.

V 1.0 - January 96 4-9

Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Enter the lot number if necessary and For all reagents which are not from STA®
confirm with the ↵ key. line of Diagnostica Stago, the following
window is displayed:

REAGENT LOADING
Should the reagent be mixed?

Y = Yes N = No

For a reagent which needs mixing, type Y. The message “LOAD THE LAST
IDENTIFIED VIAL - Esc = Correction” is
For a reagent without mixing, type N. displayed at the foot of the screen.

Place the vial in a position corresponding On the product drawer:

to its diameter while considering the The LED adjacent to the vial position lights
positions with mixing or without. up and the machine beeps:
position and identification validated
Note: If the vial is not properly positioned, On the screen:
the operator will be informed by an Automatic display of the position (Pos.).
error message.
If no lot number change is detected,
moves directly to the RESULTS box below.

If a lot number change is detected, the

following window is displayed:

LOT NUMBER CHANGED

All concerned calibrations

will be definitively invalid

Accept (YES/NO) XXX

If the lot number change is accepted, type Data for this reagent/desorb solution
YES, then confirm with the ↵ key. transferred to the top part of the screen
(zone ➓, see description on chapter 4.3.
of the STA Compact ® Operator’s Manual).

Follow the same procedure for the next

vial of reagent/desorb solution.

4 - 10 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.6. Identification and Loading of Controls/Calibrators (Product Drawer)

For identification of controls/calibrators there are two options:

– Automatic identification using bar codes;
– Manual identification using the keyboard.

4.6.1. Bar Code Identification of Controls/Calibrators and Loading (Product Drawer)

START: PRODUCT LOADING s c r e e n d i s p l aye d w i t h m e s s a g e “PRODUCT

ACTIONS RESULTS

If the control/calibrator is in its original vial,

skip the next ACTIONS box.

If the control/calibrator has been The mention Normal Vol. changes into
transferred into a microcontainer, press Microvolume (area , see description of
the F8 key. PRODUCT LOADING screen, chapter 4.3.
of the STA Compact ® Operator’s Manual).

Scan the bar code of the control/calibrator Identification (ID), name (Name), volume
in front of the reader (i.e.: STA® - COAG (Volume), stability (Stab.), and lot number
CONT N) (Lot) of the control/calibrator are displayed.

In case of failure of the bar code reader, The cursor is positioned on the Volume
proceed as indicated below, chapter 4.6.2. field for correction if any.
of the STA Compact ® Operator’s Manual.
The message “INDICATE THE VOLUME
(in ml) - Esc = Correction” is displayed at
the foot of the screen.

If the volume has to be modified, enter the The new volume is displayed.
new value, then confirm with the ↵ key.

Otherwise directly confirm with the ↵ key The cursor is positioned on the Stability
and jump to the RESULTS box below. field.

The message “INDICATE THE

STABILITY (hours) - Esc = Correction”
is displayed at the foot of the screen.

Modify if necessary the stability, then The volume and the stability are displayed.
confirm with the ↵ key.

Otherwise confirm with the ↵ key. The message “LOAD THE LAST
IDENTIFIED VIAL - Esc = correction” is
displayed at the foot of the screen.

V 1.0 - January 96 4 - 11
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Load the vial in a position corresponding On the product drawer:

to its diameter. The LED adjacent to the vial position lights
up and the machine beeps:
position and identification validated

On the screen:
Automatic display of the position (Pos.).

If no lot change is detected, skip the two

next RESULTS boxes below.

If a lot change is detected:

* For a control, the following window is
displayed:

LOT NUMBER CHANGED

For all concerned tests:

New ranges are needed
before controls can be run

Confirm (YES / NO) XXX

* For a calibrator, the following window

appears:

LOT NUMBER CHANGED

For all concerned tests:

The new concentration
must be entered when
running calibration

Confirm (YES / NO) XXX

Enter YES then confirm with the ↵ key. The following window is displayed:

Please pass the code sheet

in front of the reader

Esc: Quit

Scan the bar code sheet in front of the At the end, the following window appears:
reader.

In case of failure of the bar code reading, BAR CODE READING

enter the data printed under the bar codes
and confirm with the ↵ key each line end.
Data Processing End

Esc: Cancel this message

4 - 12 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

ACTIONS RESULTS

Press the Esc key. Data for this control/calibrator transferred

to the top part of the screen (zone 1 0 , see
Caution! For all related tests, the values description on chapter 4.3. of the STA
of calibrators or control ranges Compact ® Operator’s Manual).
will be properly dispatched in
the various screens on
condition that the primary unit
chosen for the test will be
identical to that used on the bar
code sheet (except: Fibrinogen).

Follow the same procedure for the next

vial of control/calibrator.

4.6.2. Manual Identification of Controls/Calibrators and Loading (Product Drawer)

START: PRODUCT LOADING s c r e e n d i s p l aye d w i t h m e s s a g e “PRODUCT

ACTIONS RESULTS

If the control/calibrator is in its original vial,

skip the next ACTIONS box.

Enter the alphanumeric identification of The identification of the control/calibrator is

the control/calibrator as defined in the displayed.
TEST SETUP screens (including spaces),
then confirm with the ↵ key. The cursor is positioned on the Name field.

The product chosen for this example is the

STA® - COAG CONT N.

Enter the product name : STA - COAG The name of the control/calibrator is
CONT N (in this case) as it was defined in displayed.
the TEST SETUP screen (see chapter 3.1.
of the STA Compact ® Operator’s Manual) The cursor is on the Volume field.
then confirm with the ↵ key.
The message “INDICATE THE VOLUME
(in ml) Esc =Correction” is displayed at
the foot of the screen.

Enter the volume, then confirm with the ↵ The volume is displayed.
key.
The cursor is on the Stab. field.

The message" INDICATE THE

STABILITY (hours) - Esc = Correction"
is displayed at the foot of the screen.

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Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Enter the stability, then confirm with the ↵ The stability is displayed.
key.
The cursor is on the Lot field.

The message" INDICATE THE LOT

NUMBER - Esc = Correction" is
displayed at the foot of the screen.

Enter the lot number indicated on the vial, The message “LOAD THE LAST
then confirm with the ↵ key. IDENTIFIED TUBE - Esc = Repeat ident”
is displayed in yellow at the foot of the
screen.

Load the vial in a position corresponding On the product drawer:

to its diameter. The LED adjacent to the vial position lights
up and the machine beeps: position and
identification validated.

On the screen:
Automatic display of the position (Pos.).

If no lot change is detected, skip to the

next RESULTS box below.

If a lot number change is detected:

* For a control, the following window is
displayed:

LOT NUMBER CHANGED

For all concerned tests:

New ranges are needed
before controls can be run

Confirm (YES / NO) XXX

* For a calibrator, the following window

appears:

LOT NUMBER CHANGED

For all concerned tests:

The new concentration
must be entered when
running calibration

Confirm (YES / NO) XXX

If the lot number change is accepted, Data for this control/calibrator transferred
enter YES then confirm with the ↵ key. to the top part of the screen (zone ➓, see
description on chapter 4.3. of the STA
Caution! The values of the quality control Compact ® Operator’s Manual).
ranges must be modified in the
related screens, otherwise, the
test will be blocked.

Follow the same procedure for the next

vial of control/calibrator.

4 - 14 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.7. Identification and Loading of Diluents (Sample Drawer)

4.7.1. Description of the Entry Zone for a Diluent

Fig. 4 - Entry Zone for a Diluent

➊ Identification number for the diluent with indication of the sample type: Normal Tube or
Microtube

➋ Position within drawer

➌ Complete name of the diluent

➍ Diluent volume

➎ Diluent stability

❻ Lot number of the diluent (if used)

4.7.2. Bar Code Identification of Diluents and Loading (Sample Drawer)

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as
described in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Scan the bar code of the product in front The STA beeps and the following window
of the reader (i.e.: Owren - Koller Buffer). appears:

In case of failure of the bar code reader, Product detected

proceed as indicated below, chapter 4.7.3.
of the STA Compact ® Operator’s Manual. F1: Diluent
11361

F2: Sample
xxx C2: 6199B

xxx : Recall of the prefix if the latter has been

defined.

Press the F1 key. The diluent name is displayed as well as

the volume and the stability.

The cursor is positioned on the Volume

box (zone ➍, see description above,
chapter 4.7.1. of the STA Compact ®
Operator’s Manual).

V 1.0 - January 96 4 - 15
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

If the volume has to be modified, enter the The new volume is displayed.
new value, then confirm with the ↵ key.

Otherwise directly confirm with the ↵ key The cursor is positioned on the Stability
and jump to the RESULTS box below. box (zone ➎, see description above,
chapter 4.7.1. of the STA Compact ®
Operator’s Manual).

Modify if necessary the stability, then The message “LOAD THE LAST IDENTIFIED
confirm with the ↵ key. TUBE - Esc = Repeat ident” is displayed
in yellow at the foot of the screen..
Otherwise confirm with the ↵ key.

Load the diluent vial in the reserved On the sample drawer:

position (No. 8) or in any other position. The LED adjacent to the product position
lights up and the STA beeps = position
and identification validated.

On the screen:
Automatic display of the position and data
transferred into the zone for samples
already loaded (zone ➎, see description of
SAMPLE LOADING screen, chapter 4.4.
of the STA Compact ® Operator’s Manual).

4.7.3. Manual Identification of Diluents and Loading (Sample Drawer)

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as
described in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Enter the alphanumeric identification of The following window is displayed :

the product as defined in the TEST
SETUP screens (including spaces), then Product detected
confirm with the ↵ key.
F1: Diluent
The product chosen for this example is the 11361
Owren - Koller Buffer.
F2: Sample
11361

Press the F1 key to confirm the product The entry zone for diluent is displayed
type (F2 allows loading a sample whose (see description above, chapter 4.7.1. of
identity will be the same as that of a the STA Compact ® Operator’s Manual).
dilution buffer).
The cursor is positioned on the complete
name field (zone ➌, see description
above, chapter 4.7.1. of the STA Compact
® Operator’s Manual).

Enter the product name : Owren - Koller The cursor is positioned on the Volume
(in this case) as it was defined in the TEST field (zone ➍, see description above
SETUP screen (see chapter 3.1. of the chapter 4.7.1. of the STA Compact ®
STA Compact ® Operator’s Manual) then Operator’s Manual).
confirm with the ↵ key.

4 - 16 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

ACTIONS RESULTS

Enter the volume, then confirm with the ↵ The cursor is positioned on the Stability
key field (zone ➎, see description above,
chapter 4.7.1. of the STA Compact ®
Operator’s Manual).,

Enter the stability, then confirm with the ↵ The message “LOAD THE LAST IDENTIFIED
key. TUBE - Esc = Repeat ident” is displayed
in yellow at the foot of the screen.

Load the diluent vial in the reserved On the sample drawer:

position (No. 8) or in any other position. The LED adjacent to the position lights up
and the STA beeps = position and
identification validated.

On the screen:
Automatic display of the position and data
transferred into the zone for samples
already loaded (zone ➎, see description
of SAMPLE LOADING screen, chapter
4.4. of the STA Compact ® Operator’s
Manual).

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Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.8. Sample Identification and Loading (Sample Drawer)

4.8.1. Introduction to Sample Identification and Test Selection

• Samples can be identified in a number of ways:

– Bar code identification with or without prefix;

– Manual identification with or without prefix;
– Automatic identification (with or without test selection).

•There are also several ways of selecting tests:

– Individual selection;
– Selection by profile;
– Tele-loading from Host computer;
– Automatic display of the list of tests.

☞ Caution! The number of tests for each Patient File is limited to 12.

All pairs are possible (see below):

<————————— 1—Test Selection————————15 1—->

Host
Individual Profile Computer Automatic
Tele-loading Display

↑ Manual with prefix X X X X

Sample Manual without prefix X X X X

Identification Bar codes with prefix X X X X

↓ Bar codes without prefixes X X X X

The AUTO mode is dealt with separately because it incorporates the notions of prefix and test
selection.
For the special case of the automatic display of the test list, see chapter 4.8.7. of the STA
Compact ® Operator’s Manual.

4.8.2. Definition of a Prefix

A prefix can be defined regardless of whether identification is manual or by bar codes. It is also
possible whether for the MANUAL Mode or the AUTO Mode.
The prefix can serve to differentiate the different populations of samples according to criteria
chosen by the laboratory.

For example: POP for pre-operative, HEP for a patient treated with Heparin, AVK for a patient
treated with anti-vitamin K...

4 - 18 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.3. Definition of a Test Profile

For the MANUAL Mode, up to 7 different test profiles can be defined, and these can be modified
at any time.
For the AUTO Mode, only one profile is used, which is called AUTO profile.

☞ Caution! The number of tests per profile is limited to 6. Several profiles can be cumulated to
the amount of 12 tests per Patient file (MANUAL Mode).

Fig. 5 - PROFILE MODIFICATION Screen

➊ Name of the screen

➋ List of profiles

➌ Display zone for the list of available tests

➍ Available functions:

The ↵ key (Modify) leads to the following functions:

↵ Insert/Remove Adds or deletes one or more tests for a selected profile.

0 Teleloading Downloads tests from a central computer.

F10 Save Validates the modification or creation of a profile.

Esc Abandon Returns to the first profile of the list of profiles without
saving the modifications.

Esc Quit Returns to the SAMPLE LOADING screen.

V 1.0 - January 96 4 - 19
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.8.3.1. Create a Test Profile

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described
in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key (Options). For the MANUAL Mode, the following
window appears:

Change Profiles
Change Prefix
AUTO Mode

Return to Loading
Quit

For the AUTO Mode, the following window

appears:

Change Profile
Change Prefix/First Number
MANUAL Mode

Return to Loading
Quit

In both cases, the cursor is positioned on

Quit.

Press the C key (Change Profile). The PROFILE MODIFICATION screen

appears (see description above).
Or move the cursor to Change Profile
with the ↓ key then confirm with the ↵ key.

Move the cursor after the last profile using The list of available tests appears with the
the ↓ key, then confirm with the ↵ key cursor on the first test.

Select the desired tests by moving the The selected tests appear in area ❷ of
cursor using the cursor keys ↓,→ , ↑ and the PROFILE MODIFICATION screen
← and confirm the choice of each test (see above).
with the ↵ key.

Or press the 0 key (Teleloading). By teleloading is displayed in area ❷ of

the PROFILE MODIFICATION screen (see
above).

Save the new profile by pressing the F10 The new profile is validated.
key.

Press the Esc key. Return to the SAMPLE LOADING screen.

4 - 20 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.3.2. Modify a Profile

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as
described in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTATS

Press the Esc key (Options). The following window appears:

Change Profiles
Change Prefix
AUTO Mode

Return to Loading
Quit

For the AUTO Mode, the following window

appears:

Change Profile
Change Prefix/First Number
MANUAL Mode

Return to Loading
Quit

In both cases, the cursor is positioned on

Quit.

Press the C key (Change Profile). The PROFILE MODIFICATION screen

appears (see description above).
Or move the cursor to Change Profile
with the ↓ key then confirm with the ↵
key.

Move the cursor to the desired profile The list of available tests appears with the
using the ↓ key, then confirm the choice cursor on the first test.
with the ↵ key.

Select the desired tests by moving the The selected tests appear in area ❷ of
cursor using the cursor keys ↓, →, ↑ and the PROFILE MODIFICATION screen
← and confirm the choice of each test (see above).
with the ↵ key.

or press the 0 key (Teleloading). By teleloading is displayed in area ❷ of

the PROFILE MODIFICATION screen (see
above).

Save the profile by pressing the F10 key. The profile is validated.

Press the Esc key. Return to the SAMPLE LOADING screen.

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Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.8.4. Sample Type

4.8.4.1. Generalities on Sample Type

Several sample categories can be distinguished:

– Normal samples: loaded in standard tubes with enough plasma to perform the requested
tests and non-urgent;
– STAT samples;
– Samples transferred into microcontainers.

Whether for the MANUAL Mode of for the AUTO Mode, the sample type has to be defined while
identifying the sample, by the F8 key for samples transferred into microcontainers or by the F12
key for the STAT samples.
A STAT sample can be transferred into a microcontainer.

Note: The STAT samples are identified in yellow. For the STAT sample processing, see
chapter 4.12. of the STA Compact ® Operator’s Manual.

4.8.4.2. Sample Type Definition

START: LOADING SAMPLE screen displayed in MANUAL Mode or in AUTO Mode (see
description, chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

If the sample is normal (Non STAT, not

transferred into a microcontainer),
proceed with its identification (see below,
chapters 4.8.5. (MANUAL Mode) or 4.8.6.
(AUTO Mode) of the STA Compact ®
Operator’s Manual).

If it is a STAT sample, press the F12 key. The indication Normal tube changes from
blue to yellow (zone of SAMPLE
LOADING screen, see description of this
screen, chapter 4.4. of the STA Compact
® Operator’s Manual).

If the sample has been transferred into a The indication Normal tube changes into
microcontainer, press the F8 key. Microtube (zone of SAMPLE LOADING
screen, see description of this screen,
chapter 4.4. of the STA Compact ®
Operator’s Manual).

If the sample is a STAT sample which has The indication Microtube is displayed in
been transferred into a microcontainer, yellow (zone of SAMPLE LOADING
press both keys F8 and F12. screen, see description of this screen,
chapter 4.4. of the STA Compact ®
Operator’s Manual).

4 - 22 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.5. MANUAL Mode

4.8.5.1. Access to MANUAL Mode

This procedure is not necessary if MANUAL MODE is already displayed in zone ➌ , (see
description of SAMPLE LOADING screen, chapter 4.4. of the STA Compact ® Operator’s
Manual).

START: SAMPLE LOADING screen displayed with AUTO MODE (as described in chapter 4.4.
of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Change Profile
Change Prefix/First Number
MANUAL Mode

Return to Loading
Quit

with cursor on Quit.

Press the M key (MANUAL Mode). Return to SAMPLE LOADING with the
indication: MANUAL MODE displayed in
zone ➌ (see description of SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual).

Or move the cursor to MANUAL Mode The message “SAMPLE IDENTIFICATION (F12
with the ↓ key then confirm with the ↵ key. = in priority F8 = Normal/ Micro Tube)”
is displayed at the foot of the screen.

4.8.5.2. Selecting a Prefix

START: SAMPLE LOADING screen with MANUAL Mode is displayed (as described in chapter
4.4. of the STA Compact ® Operator’s Manual) with the message “SAMPLE
IDENTIFICATION (F12 = in priority F8 = Normal/Micro Tube)” displayed at the foot of
the screen.

ACTIONS RESULTS

Press the Esc key (Options). The following window appears:

Change Profiles
Change Prefix
AUTO mode

Return to Loading
Quit

with the cursor on Quit.

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Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Move the cursor with the ↓ key to Change The following window appears:
prefix, then confirm with the ↵ key.
New Prefix
[- ] ↵ Save
↓ Recorded Prefix
Esc Abandon

with the cursor in the entry zone for the

prefix.

To delete the current prefix, press the Go to the last RESULTS box below.
key until the prefix is completely
erased, then confirm with the ↵ key.

To define a free prefix, type the free Return to SAMPLE LOADING. The chosen
desired prefix then confirm with the ↵ key. prefix is displayed in the sample
identification area (area , see description
of the SAMPLE LOADING screen,
chapter 4.4. of the STA Compact ®
Operator’s Manual).

Any manual or bar code identification will

then be preceded by this prefix (displayed
in area ➍ of the SAMPLE LOADING screen).

4.8.5.3. Bar Code Identification of Samples and Tube Loading

Note: This can be done with or without prefix.

START: SAMPLE LOADING screen with MANUAL Mode displayed and the cursor is in the sample
entry zone (as described in chapter 4.4. of the STA Compact ® Operator’s Manual).
The sample type has been defined (see chapter 4.8.4.2. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Scan the sample tube in front of the bar The tube identification appears on the
code reader. screen in the ID zone (zone , see
description of the SAMPLE LOADING
screen, chapter 4.4. of the STA Compact
® Operator’s Manual) and the message
“LOAD THE LAST IDENTIFIED TUBE -
Esc = Repeat ident” appears in yellow at
the foot of the screen.

Place the sample tube in any position of On the sample drawer:

the sample drawer. The LED adjacent to the tube position
lights up and the machine beeps = position
and identification validated.

Caution! You have to place the tube On the screen:

within 10 seconds, otherwise Automatic display of the position within the
the tube will have to be identified drawer (example A4) and the message
again. “INDICATE TESTS TO PERFORM - F10 =
VALIDATE” is displayed at the foot of the
screen.

Proceed to test selection (see below).

4 - 24 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.5.4. Manual Identification of Samples and Tube Loading

Note: This can be done with or without prefix.

START: SAMPLE LOADING screen with MANUAL Mode displayed and the cursor is in the
sample entry zone (as described in chapter 4.4. of the STA Compact ® Operator’s
Manual).
The sample type has been defined (see chapter 4.8.4.2. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Enter the sample identification on the The message “LOAD THE LAST
keyboard and confirm with the ¿ key. IDENTIFIED TUBE - Esc = Repeat ident”
is displayed in yellow at the foot of the
screen.

Place the sample tube in any position of On the sample drawer:

the sample drawer. The LED adjacent to the tube position
lights up and the machine beeps = position
and identification validated.

Caution! You have to place the tube On the screen:

within 10 seconds, otherwise Automatic display of the position within the
the tube will have to be again drawer (example A4) and the message
identified. “INDICATE TESTS TO PERFORM - F10 =
VALIDATE” displayed at the foot of the
screen.

Proceed to test selection (see below).

4.8.5.5. Auto-incrementation of Sample Identification and Tube Loading

It is possible through the * key.

If it is used upon opening of drawer, the generated identification is 1.
If it is used during loading, the generated identification is that of the preceding patient
file plus 1.

Example: Preceding File Generated Identification

SMITH SMITH 1

100 101

MAT100 MAT101

START: SAMPLE LOADING screen with MANUAL Mode displa yed and the cursor is in the
sample entry zone (as described in chapter 4.4. of the STA Compact ® Operator’s
Manual).
The sample type has been defined (see chapter 4.8.4.2. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Press the * key. Generated identification = 1, if no tube

loaded previously.

Generated Identification = Identification of

the file previously loaded +1.

V 1.0 - January 96 4 - 25
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Confirm the generated identification with The message “LOAD THE LAST IDENTIFIED
the ↵ key. TUBE - Esc = Repeat ident” appears in
yellow at the foot of the screen.

Place the sample tube in any position of On the sample drawer:

the sample drawer. The LED adjacent to the tube position
lights up and the machine beeps = position
and identification validated.

Caution! You have to place the tube On the screen:

Proceed to test selection (see below).

4.8.5.6. Individual Selection of Test

START: Tube already in progress identified and loaded (see above). SAMPLE LOADING screen
with message “INDICATE TESTS TO PERFORM - F10 = VALIDATE” already
displayed and cursor positioned on the first test of the Selection zone (zone ➓, see
description of the SAMPLE LOADING screen, chapter 4.4. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Select the desired tests by moving the The selected tests appear in the Test
cursor to them using the cursor keys ↓, ↑, Selection zone for the sample being
← and → and confirm the choice of each loaded (zone , see description of the
test with the ↵ key. SAMPLE LOADING screen, chapter 4.4.
of the STA Compact ® Operator’s Manual).

Save the test selection with the F10 key. Data for this sample are transferred into
the zone for samples already loaded (zone
➎, see description of SAMPLE LOADING
screen, chapter 4.4. of the STA Compact
® Operator’s Manual).

4.8.5.7. Selecting Tests by Profiles

• Selecting Profiles by a Figure (1 to 7).

ACTIONS RESULTS

Press on key (1 to 7) corresponding to The selected test profiles appear in the

desired profile. Test Selection zone for the sample being
loaded (zone , see description of
SAMPLE LOADING screen, chapter 4.4. of
the STA Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

ACTIONS RESULTS

Validate the sample with the F10 key. Data for this sample are transferred into
the Samples already loaded zone (zone
➎, see description of SAMPLE LOADING
screen, chapter 4.4. of the STA Compact®
Operator’s Manual).

• Selecting Profiles by Moving the Cursor.

ACTIONS RESULTS

Press the ← key. The cursor is positioned on the first profile

of the Recorded Profiles area (area ➒,
see description of the SAMPLE LOADING
screen, chapter 4.4. of the STA Compact®
Operator’s Manual).

Move the cursor to each selected profile The selected test profiles appear in the
then save each profile with the ↵ key. Test Selection zone for the sample being
loaded (zone , see description of
SAMPLE LOADING screen, chapter 4.4.
of the STA Compact ® Operator’s Manual).

Save the sample with the F10 key. Data for this sample are transferred into
the Samples already loaded zone (zone
➎, see description of SAMPLE LOADING
screen, chapter 4.4. of the STA Compact
® Operator’s Manual).

4.8.5.8. Teleloading Tests from Host Computer

The BY TELELOADING option is chosen by means of a profile (see chapter 4.8.3. of the STA
Compact ® Operator’s Manual).
The VERIFY PATIENT DATA option is defined within Global Options menu (see chapter 8.2.3.1.
of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the key (1 to 7) corresponding to BY TELELOADING is displayed in the

the BY TELELOADING profile. Test Selection zone for the sample being
loaded (zone , see description of the
Or press the ← key,then the ↓ key to SAMPLE LOADING screen, chapter 4.4.
move the cursor to the BY TELELOADING of the STA Compact ® Operator’s Manual).
profile and confirm with the ↵ key.

V 1.0 - January 96 4 - 27
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Confirm the sample with the F10 key. If the VERIFY PATIENT DATA option is
set to NO, data for this sample are
transferred into the samples already
loaded zone (zone ➎, see description of
SAMPLE LOADING screen, chapter 4.4. of
the STA Compact ® Operator’s Manual).

If the VERIFY PATIENT DATA option is

set to YES, the following windows are
displayed:

TELELOADING

Please wait
Esc = Abandon

TELELOADED FILE

ID: XXX ➊
Patient: XXX XXX
XXX ➋ XXX

F10: Save Esc: Cancel

❶ Patient File identification

➋ Complentary Information( Name,
First name...) see definitions,
chapter 8.2.3.3. of the STA Compact ®
Operator’s Manual.

If the data sent back by the Host Data for this sample are transferred into
Computer are correct, press the F10 key. the Samples already loaded zone (zone
➎ see description of SAMPLE LOADING
screen, chapter 4.4. of the STA Compact
® Operator’s Manual).

If the data sent back by the Host The following window displays:
Computer are not correct, press the Esc
key. SAMPLE LOADING
MAINFRAME
Can you verify if the tube is removed
F10: Remove

The LED near the tube blinks.

Remove the tube and confirm with the

F10 key.

4.8.6. AUTOMATIC Mode

This mode allows fast loading of samples for which:

– the test profile requested is identical;
– the identification numbers are successive or by means of bar codes.

4 - 28 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.6.1. Access the AUTO Mode

This procedure is not necessary if AUTO MODE is already displayed in zone 3 (see description
of SAMPLE LOADING screen, chapter 4.4. of the STA Compact ® Operator’s Manual).

START: SAMPLE LOADING screen displayed with MANUAL MODE (as described in chapter
4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window appears:

Change Profiles
Change Prefix
AUTO Mode

Return to Loading
Quit

with the cursor on Quit.

Press the A key (AUTO Mode), Return to SAMPLE LOADING screen

with AUTO MODE displayed in area ➌
(see description of SAMPLE LOADING
screen, chapter 4.4. of the STA
Compact ® Operator’s Manual).

Or move the cursor to AUTO Mode with The message: “↵ = FILE EDITING - (F12 =
the ↓ key, then confirm with the ↵ key. in priority - F8 = Normal/Micro Tube)”
displayed at the foot of the screen.

4.8.6.2. Definitions of the Prefix and of the First Number for the AUTO Mode

START: SAMPLE LOADING screen displayed with AUTO Mode (as described in chapter
4.4. of the STA Compact ® Operator’s Manual) and Message “↵ = FILE EDITING (F12
= in priority F8= Normal/Micro Tube)” displayed at the foot of the screen.

ACTIONS RESULTS

Press the Esc key (Options). The following window is displayed:

Change Profile
Change Prefix/First Number
MANUAL Mode

Return to Loading
Quit

with the cursor positionned on Quit.

Move the cursor to Change Prefix/First The New Parameters window is displayed
Number with the ↓ key, then confirm with with the cursor on the entry zone for the
the ↵ key. prefix.

To delete the current prefix, press the Skip to RESULTS box below.
key until the prefix is completely
erased, then confirm with the ↵ key.

To define a free prefix, type the free The cursor is positioned on the entry zone
desired prefix, then confirm with the ↵ key. for the first number.

V 1.0 - January 96 4 - 29
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Type the first number, then confirm with Return to SAMPLE LOADING.
the F10 key.
The parameters defined for the AUTO
Mode: Profile, prefix and first number, are
displayed in the Parameters zone
(zone ,see description of the SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual).

The identification of the first sample is

displayed in the ID zone for the sample
being loaded (zone ,see description of
the SAMPLE LOADING screen, chapter
4.4. of the STA Compact ® Operator’s
Manual).

4.8.6.3. Use of AUTO Mode

START: SAMPLE LOADING screen displayed, with AUTO MODE and cursor positioned on
the entry zone for the sample (as described in chapter 4.4. of the STA Compact ®
Operator’s Manual).
The sample type has been defined (see chapter 4.8.4.2. of the STA Compact ®
Operator’s Manual).
The test profile has been defined, see chapter 4.8.3. of the STA Compact ®
Operator’s Manual.
The prefix and the first number have been selected, see procedure, chapter 4.8.6.2.
of the STA Compact ® Operator’s Manual.

ACTIONS RESULTS

Press the ↵ key. The message “LOAD THE LAST

IDENTIFIED TUBE” is displayed in yellow
Or scan the sample tube in front of the bar at the foot of the screen.
code reader.

Place the sample tube in any position of On the sample drawer:

the drawer. The LED adjacent to the tube position
lights up and the machine beeps = position
and identification validated.

Caution! You have to place the tube On the screen:

within 10 seconds, otherwise Data for this sample is transferred into the
the tube will have to be again Samples already loaded zone (zone ➎,
identified. see description of the SAMPLE LOADING
screen, chapter 4.4. of the STA Compact
® Operator’s Manual) with automatic
display of the position within the drawer
(example A4), the message “↵ = FILE
EDITING (F12 = in priority F8 = Normal
Tube/Micro Tube)” is displayed at the
foot of the screen.

Proceed to the next tube loading.

Note: at any time, the sample type can
be changed.

4 - 30 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.8.7. Sample Loading with Automatic Display of the List of Tests

The automatic display of the list of tests is only possible for Patient files already known by the
STA Compact ® because they have been already loaded, processed then removed.

This automatic display can occur for the MANUAL Mode as well as for the AUTO Mode.

Note: Modifying the sample type or the list of tests will only be possible after loading of the
sample tube by means of the ↑ key List/Change (see description, chapter 4.9.2. of
the STA Compact ® Operator’s Manual).

START: SAMPLE LOADING screen displayed (MANUAL Mode or AUTO Mode), (as described
in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Enter the sample identification on the The list of tests is automatically displayed
keyboard, then confirm with the ↵ key. in the TEST SELECTION zone for the sample
being loaded (zone , see description of
the SAMPLE LOADING screen, chapter
4.4. of the STA Compact ® Operator’s
Manual).

Or scan the sample tube in front of the bar The message “LOAD THE LAST
code reader. IDENTIFIED TUBE - Esc = Repeat ident
(ALREADY EXISTS)” is displayed in yellow
at the foot of the screen.

Place the sample tube in any position of On the sample drawer:

the sample drawer. The LED adjacent to the tube position
lights up and the machine beeps = position
and identification validated.

Caution! You have to place the tube On the screen:

within 10 seconds, otherwise Data for this sample are transferred into
the tube will have to be again the zone for samples already loaded
identified. (zone ➎, see description of SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual) with
automatic display of the position within the
drawer (example A4).

STA Compact ® ready for loading of the

next sample.

V 1.0 - January 96 4 - 31
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.9. Modification on Loaded Products or Samples

4.9.1. Modification Procedure for the Product Drawer

Note: This procedure is only possible for controls, calibrators, reagents or desorb solutions
already loaded during a loading session. The possible modifications concern:

– the volume;
– the stability;
– the indication Normal Vol./Microvolume.

START: PRODUCT LOADING s c r e e n d is p laye d w ith m es s a g e “PRODUCT

IDENTIFICATION (F8 = Normal Vol./Microvolume)”at the foot of the screen and
Normal Vol. displayed in area (see description of PRODUCT LOADING screen,
chapter 4.3. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTATS

Press the ↑ key. The cursor is positioned on the last line of

the zone of products already loaded (zone
➓, see description of the PRODUCT
LOADING screen, chapter 4.3. of the STA
Compact ® Operator’s Manual).

Move the cursor on the required control/ Cursor positioned on the required
calibrator/reagent/desorb solution with the control/calibrator/reagent/desorb solution.
↑ key.

Press the ↵ key. All control/calibrator/reagent/desorb

solution information is displayed in Entry
Zone (zone , see description of the
PRODUCT LOADING screen, chapter 4.3.
of the STA Compact ® Operator’s Manual).

The cursor is positioned on the volume

field.

The message “INDICATE THE VOLUME

(in ml) - Esc = Cancel” is displayed at the
foot of the screen.

If it is necessary to modify the volume, The new volume is displayed.

type the new value, then confirm with the
↵ key. The cursor is positioned on the Stability
field.

Otherwise, confirm directly with the ↵ key The message “INDICATE THE
and jump to the RESULTS box below. STABILITY (hours) - Esc = Cancel” is
displayed at the foot of the screen.

Modify if necessary the stability, then Volume and stability are displayed.
confirm with the ↵ key.

Otherwise, confirm directly with the ↵ key. The cursor is positioned on the field
indicating Normal Vol. or Microvolume.

The message “↵ = MODIFY (F8 = Normal

Vol./Microvolume - Esc = Cancel” is
displayed at the foot of the screen.

4 - 32 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

ACTIONS RESULTATS

Change if necessary the indication Data for this control/calibrator/reagent/

Normal Vol./Microvolume with the F8 desorb solution transferred to the top part
key, then confirm with the ↵ key. of the screen (zone ➓, see description of
the PRODUCT LOADING screen, chapter 4.3.
Otherwise, confirm modifications with the of the STA Compact ® Operator’s Manual).
↵ key.

4.9.2. Modification Procedure for the Sample Drawer

Note: This procedure is only possible for samples or diluents already loaded during a loading
session.

For samples, the possible modifications are:

– the list of tests for Manual Mode;

– the indication Normal Tube/Microtube (F8 key);
– the indication Normal/STAT (F12 key).

For diluents, the possible modifications are:

– the volume;
– the stability;
– the indication Normal Tube/Microtube (F8 key).

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as
described in chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the ↑ key. The cursor is positioned on the last line of

the zone for samples already loaded
(zone ➎ see description of SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual).

Move the cursor to the requested sample Cursor positioned on the requested
or product. sample or diluent.

Press the ↵ key. All data from this sample (diluent) are
displayed in the entry zone (zone

The cursor is positioned on the indication:

(Normal tube) or (Microtube) with
message “F12 = in priority -
F8 = Normal/ Micro Tube” displayed at
the foot of the screen.

If necessary and depending on cases, The (Normal tube) indication changes to

press the F8 key. (Microtube) or reversely.

or / and press the F12 key. The (Normal tube) or (Microtube)

indication display changes from blue
(normal sample) to yellow (STAT sample).

Then, press the ↵ key. For samples, possibility to modify the list of
tests (see procedures, chapters 4.8.5.6.,
4.8.5.7.and 4.8.5.8. of the STA Compact ®
Operator’s Manual).

V 1.0 - January 96 4 - 33
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Caution! For AUTO Mode, it is not For diluents, possibility to modify the
possible to change the list of volume and/or the stability (see
tests, automatic return to loading. procedures, chapter 4.7.of the STA
Compact ® Operator’s Manual).

For samples, validate the modifications by Return to loading procedure: cursor

the F10 key. positioned on the sample identification
entry zone.

For diluents, validate the modifications by Message “SAMPLE IDENTIFICATION

the ↵ key. (F12 = in priority F8 = Normal/ Micro
Tube) displayed at the foot of the screen.

4 - 34 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.10. Unloading of Samples or Products

4.10.1. Unloading with Positive Identification

Note: This procedure is only possible for samples or products (reagents, controls, calibrators,
desorb solutions or diluents) loaded with positive identification; i.e.: automatic
acknowledgement of loading position within drawer by STA Compact ®.

Reminder: The LEDs adjacent to tubes (vials) are blinking:

– for samples whose related Patient files are complete;

– for products which have stability overdue or insufficient liquid.

START: SAMPLE LOADING screen with MANUAL Mode or AUTO Mode displayed (as described
in chapter 4.4. of the STA Compact ® Operator’s Manual ).
or PRODUCT LOADING screen displayed (as described in chapter 4.3. of the STA
Compact ® Operator’s Manual).

ACTIONS RESULTS

Remove the tube (or vial). The LED adjacent to the tube (vial) lights
off.

The identification of the tube (vial)

disappears from the list of samples
(products) already loaded.

4.10.2. Unloading without Positive Identification

Note: This unloading procedure is only possible for products or samples present in the drawer
currently open.
It is absolutely necessary for products or samples loaded without Positive identification.

START: SAMPLE LOADING screen with MANUAL Mode or AUTO Mode displayed (as described
in chapter 4.4. of the STA Compact ® Operator’s Manual).
or PRODUCT LOADING screen displayed (as described in chapter 4.3. of the STA
Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the ↑ List/Change. The cursor is positioned on the last line of

the zone for loadings already performed:
zone ➎ (see description of SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual) or zone ➓
(see description of PRODUCT LOADING
screen, chapter 4.3. of the STA Compact ®
Operator’s Manual).

Move the cursor to the requested Patient Cursor positioned on the requested patient
file or product with the ↑ key. file or product.

V 1.0 - January 96 4 - 35
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the Delete key. For the sample drawer, the following
window is displayed:

SAMPLE LOADING

Are you sure you want to remove the

sample (product) from the drawer?

Y=YES N=NO

For the product drawer, the following

window is displayed:

PRODUCT LOADING

Are you sure you want to remove the

product from the drawer?

Y=YES N=NO

Remove the tube (or vial), then press the If the LED adjacent to the tube (vial) was
Y key. lit, it goes off.

The identification of the tube (vial)

disappears from the list of samples
(products) already loaded.

4 - 36 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.11. Loading without Positive Identification

If the positive identification is no longer functional (totally or partly) on the sample drawer or on
the product drawer, the tube or vial position can be given manually (see procedure below).

☞ Caution! - This procedure requires intensive care from the operator who shall insure that
the positions he types, are consistent with the actual loadings.

- For all tubes or vials loaded with this procedure, it is absolutely necessary to
observe the unloading procedure without positive identification (see chapter
4.10.2. of the STA Compact ® Operator’s Manual).

4.11.1. Sample Drawer Procedure

START: SAMPLE LOADING screen is displayed (with MANUAL Mode or AUTO Mode).
Sample already identified, tube ready to be loaded. Message “LOAD THE LAST
IDENTIFIED TUBE - Esc = Repeat ident” displayed at the foot of the screen and
cursor positioned on the “Pos.” box (area ➐, see description of the SAMPLE LOADING
screen, chapter 4.4. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Load the sample tube (or the sample The tube position is not displayed on the
adaptator) in any position of the sample screen.
drawer .
On the sample drawer, the LED adjacent
to the tube does not light up.

Enter the tube position on the keyboard by Position (i.e.: G4) displayed on the screen.
typing first the letter indicated at the left
side of the line occupied by the tube The LED adjacent to the tube position
(i.e.:G), then type the number indicated at lights up or does not light up.
the bottom and on the right of the columm
occupied by the tube (i.e.: 4). For the For MANUAL MODE, the message
position reserved for diluent ➑, enter “INDICATE TESTS TO PERFORM - F10
directly the figure, then confirm with the ↵ = VALIDATE” is displayed at the foot of
key. the screen.

For AUTO MODE, the message “↵ = FILE

EDITING (F12 = in priority F8 = Normal /
Micro Tube)” is displayed at the foot of
the screen.

For diluents, automatic transfer of data

into the zone for samples already loaded
(zone ➎, see description of SAMPLE
LOADING screen, chapter 4.4. of the STA
Compact ® Operator’s Manual).

For MANUAL Mode, proceed to test

selection, (see chapters 4.8.5.6. to 4.8.5.8.
of the STA Compact ® Operator’s Manual).

V 1.0 - January 96 4 - 37
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

4.11.2. Product Drawer Procedure

START: PRODUCT LOADING screen is displayed. Reagent, desorb solution, control or

calibrator already identified (Identification, Volume, Stability, Lot number) and vial
ready to be loaded. Message “LOAD THE LAST IDENTIFIED VIAL - Esc =
Correction” displayed at the foot of the screen and cursor positioned on the “Pos.”
Box.

ACTIONS RESULTS

Place the vial in a position corresponding The vial position is not displayed on the
to its diameter while considering the screen.
positions with mixing or without.
On the product drawer, the LED adjacent
to the vial does not light up.

Enter directly on the keyboard the vial On the screen, display of the position and
position, as indicated on its right side data for this reagent, desorb solution,
(i.e.: 11). Then confirm with the ↵ key. control or calibrator automatically
transferred to the top part of the screen
(zone ➓, see description of the PRODUCT
LOADING screen, chapter 4.3. of the STA
Compact ® Operator’s Manual).

4 - 38 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

4.12. Running Tests (Closing of Sample or Product Drawer)

Note: Running tests or stopping tests can also be performed from the Status menu (see
description, chapter 8.1.5.1. of the STA Compact ® Operator’s Manual).

As soon as the running of tests is confirmed by the operator, the samples are processed as
described below:
– pipetting of calibrators for all tests;
– pipetting of calibration controls for all tests;
– pipetting of quality controls for all tests;
– pipetting of STAT samples;
– pipetting of samples for all tests in chronological loading order.

START: SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (see
description chapter 4.4. of the STA Compact ® Operator’s Manual); or PRODUCT
LOADING screen displayed (see description, chapter 4.3. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. For the sample drawer, one of the
following windows is displayed:

* For the MANUAL Mode, the following

window appears:

Change Profiles
Change Prefix
AUTO Mode

Return to Loading
Quit

* For the AUTO Mode, the following

window appears:

Change Profile
Change Prefix/First Number
MANUAL Mode

Return to Loading
Quit

In both cases, the cursor is positioned on

Quit.

For the product drawer, the following

window is displayed:

Quit

YES
NO

with the cursor positioned on YES.

V 1.0 - January 96 4 - 39
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Confirm with the ↵ key. The sample drawer (product drawer)

closes automatically.

When all conditions are met (quality

controls or calibrations OK, no stability is
overdue, and no volume is insufficient) for
all reagents and products, the sample
pipetting starts again and the TEST
STATUS screen is displayed. The Esc key
allows to return to the TEST PANEL.

If one of the conditions previously

described is not met, for one or several
tests, the sample pipetting is blocked and
the TEST STATUS screen is displayed with
the message “BLOCKED SAMPLE
PIPETTING” displayed in red at the foot of
the screen (see description of TEST
STATUS screen, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

If sample pipetting has been blocked, The following window is displayed:

press the Esc key.
WARNING

New tests are delayed

Reactivate?

Y=YES N=NO

To reactivate tests, press the Y key. The authorized sample pipetting starts
again.

Caution! In this case, only tests with Return to TEST PANEL.

following conditions (correct
calibration, quality control,
volume and stability for all
requested products) will be run.
The other tests will be blocked.

To block tests, press the N key. Return to TEST PANEL.

Following needs:
- load the requested products;
- change the ranges of controls or
calibrators which are not from
Diagnostica STAGO.

4 - 40 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

Appendix A: List of code numbers for “Reagents”, to be loaded in product drawer.

Product Names Product Codes

STA - Neoplastine Ci ⑤
® ®
12209

STA - Neoplastine Ci ⑩
® ®
12300

STA® - C.K. PREST ⑤ 12207

STA® - PTT - LT ⑤ 12315

CaCI2 11851

STA® - Fibrinogen ⑤ 12321

STA® - Thrombin ➉ 12344

STA® - Desorb U 12227

STA® - Deficient II 12338

STA® - Deficient V 12337

STA® - Deficient VII 12336

STA® - Deficient VII - X (1) 12334

STA® - Deficient X 12335

STA® - Deficient VIII 12333

STA® - Deficient IX 12332

STA® - Deficient XI 12331

STA® - Deficient XII 12330

STA ®- Staclot® Protein C Deficient 12342

STA® - Staclot® Protein C Activator 12343

STA® - Staclot® Protein S Deficient 12339

STA ®- Staclot® Protein S PCA 12340

STA® - Staclot® Protein S FVa 12341

STA® - Staclot® Heparin ➊ substrate (2) 12345

STA® - Staclot® Heparin ➊ Xa (2) 12346

STA® - Staclot® Heparin ➊ Phospholipides 12347

Ca++ (2)

STA - Stachrom® PC Activator 12325

STA - Stachrom® PC Substrate 12326

STA - Stachrom® AT III Thrombin ➌ 12205

STA - Stachrom® AT III Substrate ➌ 12206

1 : Not available in the United States

2 : Not offered in the United States

V 1.0 -January 96 4 - 41
Loading of Products and Samples STA COMPACT ® OPERATOR'S MANUAL

Product Names Product Codes

STA - Rotachrom® LMWH Substrate 12312

STA® - Rotachrom® LMWH Xa 12313

STA® - Rotachrom® Hep Substrate ➃ 12367

STA® - Rotachrom® Hep Xa ➃ 12368

STA® - Liatest® vWF Buffer (1) 12224

STA® - Liatest® vWF Latex (1) 12225

STA® - Stachrom® AP Plasmin 12218

STA® - Stachrom® AP Substrate 12219

STA® - Stachrom® PLG Streptokinase 12216

STA® - Stachrom® PLG Substrate 12217

1 : Not available in the United States

4 - 42 V 1.0 - April 96
STA COMPACT ® OPERATOR'S MANUAL Loading of Products and Samples

Appendix B: List of code numbers for all “Other products” to be loaded in the product drawer.

Product Names Product Codes

STA® - Unicalibrator 12350

STA® - Coag Control N 12351

STA® - Coag Control P 12352

STA® - System Control N 12354

STA® - System Control P 12355

STA®- Heparin Control ➁ 12361

STA®- Heparin Control ➄ 12362

STA® - LMWH Control ➂ 12359

STA®- LMWH Control ➇ 12360

STA® - Hepanorm H 0 12363

STA®- Hepanorm H ➂ 12364

STA®- Hepanorm H ➅ 12365

STA®- Hepanorm LMWH 0 12356

STA® - Hepanorm LMWH ➃ 12357

STA® - Hepanorm LMWH ➈ 12358

STA® - vWF Calibrator (1) 12221

STA® - vWF Control N (1) 12222

STA® - vWF Control P (1) 12223

Appendix C: Diluent identification to be loaded in the sample drawer.

Diluent Name Product Code

Owren - Koller 11361

1 : Not available in the United States

V 1.0 - April 96 4 - 43
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 5

5. CALIBRATION 1

5.1. Access to a Given Calibration 1

5.1.1. Procedure for Access to a Given Calibration 1
5.1.2. Description of the CALIBRATION Screen 2

5.2. Description of Calibration Screens 3

5.2.1. Description of CALIBRATION Screens: Bar Coded Mode 3
5.2.2. Description of CALIBRATION Screens: Raw Mode 6
5.2.3. Description of CALIBRATION Screens: Ratio Mode 7
5.2.4. Description of CALIBRATION Screens: Graphic Mode 9

5.3. Procedures for Running and Validating a Calibration 14

5.3.1. General Principles 14
5.3.2. Loading Standards and Calibration Controls 15
5.3.3. Running and Validating Bar Coded Calibrations 16
5.3.4. Running and Validating Calibrations in Raw Mode 18
5.3.5. Running and Validating Calibrations in Ratio Mode 19
5.3.5.1. Running and Validating Calibrations in Ratio Mode
with Calibration Controls 19
5.3.5.2. Running and Validating Calibrations in Ratio Mode
without Calibration Controls 21
5.3.6. Running and Validating Calibrations in Graphic Mode 22
5.3.6.1. Running and Validating Calibrations in Graphic Mode
with Calibration Controls 22
5.3.6.2. Running and Validating Calibrations in Graphic Mode
without Calibration Controls. 24
5.3.7. Running Several Calibrations 25

5.4. Procedures to Observe in Case of Calibration not

Automatically Confirmed 27
5.4.1. Displayed Messages in Case of Calibration not Automatically Confirmed 27
5.4.2. Description of CALIBRATION NOT CONFIRMED Windows 28
5.4.2.1. Description of the CALIBRATION NOT CONFIRMED Window
(out of Range Controls) 28
5.4.2.2. Description of the CALIBRATION NOT CONFIRMED Window
(Absence of Controls) 29
5.4.3. Confirming out of Range Calibration Controls 29
5.4.4. Rerun Controls 30
5.4.5. Manually Confirming a Calibration Curve 31
5.4.6. Modifying then Confirming a Calibration Curve 31
5.4.7. Restoring Previous Calibration 32
5.4.8. Rerun Calibration 33
5.4.9. Cancelling Calibration 34

V 1.0 - January 96
Table of Contents, Chapter 5 STA COMPACT ® OPERATOR'S MANUAL

5.5. Other Possible Interventions on Confirmed Calibrations 35

5.5.1. Modification of 100% Point 35
5.5.2. Modifying Offset 37
5.5.3. Modifying Measures 38
5.5.4. Printout of a Calibration Curve 39
5.5.5. Modifying the ISI Value 40
5.5.6. Viewing the Information Screen 41

V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5. CALIBRATION
5.1. Access to a Given Calibration

5.1.1. Procedure for Access to a Given Calibration

START : TEST PANEL displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading - (...) - Halt

with the cursor positioned on Status.

Press the C key (Calib./Control). The sub-menu is displayed:

Or press the → key to move the cursor Calibration

to Calib./Control then confirm with the Quality Control
↵ key.
with the cursor on Calibration

Press the ↵ key. The CALIBRATION screen is displayed

(see below chapter 5.2.1. of the STA
Compact ® Operator’s Manual) with the
cursor on the first test of the list.

Move the cursor to the test for which The selected calibration screen is shown
calibration is required using the cursor (see description below, chapter 5.2. of
keys, ↓ , ↑ , →, and confirm with the ↵ key. the STA Compact ® Operator’s Manual).

V 1.0 - January 96 5-1

Calibration STA COMPACT ® OPERATOR'S MANUAL

5.1.2. Description of the CALIBRATION Screen

Fig. 1 - CALIBRATION Screen

➊ Title of the screen

➋ Available keys:

↵ Accesses the calibration of the selected test

F1 Select Calibrations to Run: requests calibration run for the test on which the cursor
is positioned.

F10 Run Selected Calibrations: runs the calibrations selected by the F1 key (see chapter
5.3.7. of the STA Compact ® Operator’s Manual).

Esc Quit: returns to the TEST PANEL screen.

➌ List of test abbreviations. A colored square displayed at the left of the abbreviation indicates
the calibration current status (see point 5 below).

➍ Complete name of the test on which the cursor is positioned

➎ Color code identifies the status of each calibration:

- White: validated.
- Blue: to be validated.
- Yellow: in progress.
- Red: not calibrated.

5-2 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Calibration

5.2. Description of Calibration Screens

5.2.1. Description of CALIBRATION Screens: Bar Coded Mode

Note: For this mode, there are two screens:

– a graphic screen;
– an information screen.
Graphic Calibration Screen - Bar Coded Mode:

Fig. 2 - Graphic Calibration Screen

- Bar Coded Mode -

➊ Complete test name

➋ Esc Options: this key opens the OPTIONS window:

OPTIONS

Information
Modify 100% Point - ISI
Print
Run Controls
Quit

* Information: displays the second screen (Information screen) of the calibration.

* Modify 100% Point - ISI: this option is only possible for clotting tests with % as the
primary unit and if the measurement scale is linear and the concentration scale is
inverse. It moves the calibration curve in a parallel direction to itself in such a way
that the calibration passes through the new point given in seconds and which
corresponds to 100%.

It also allows access for ISI modification (International Sensitive Index) if INR
(International Normalized Ratio) has been chosen as the unit.

* Print: (only possible if STA Compact ® is in stand-by mode). Printout of the two calibration
screens: graphic and information.

V 1.0 - January 96 5-3

Calibration STA COMPACT ® OPERATOR'S MANUAL

* Run Controls: modifies the calibration control ranges if those have been defined and
runs them (F10 key).

* Quit: returns to CALIBRATION screen (test list).

➌ Date and Time of calibration control validation

➍ Calibration control results given in the primary unit:

– xxx : waiting for calibration control results;

– —— : calibration controls are running;
– results displayed in white : calibration control results are validated in normal conditions;
– results displayed in red : calibration control results are validated although those
and preceded by an asterik were out of range.

➎ ISI value (International Sensitive Index).

It is displayed only if INR (International Normalized Ratio) has been chosen as the unit.

➏ Value in seconds for the point corresponding to 100%. It is displayed only if it has been
modified and if the modification is possible, see above, point 2 .

➐ Raw data values (sec, ∆.Ο.D., O.D./min) after interpolation from the calibration curve.

➑ View points as defined in the TEST SETUP screens (see chapter 3.1.2.2. of the STA
Compact ® Operator’s Manual).

➒ Graphic representation of the calibration curve.

➓ Equation of the calibration curve.

Reminder:The parameters come from the bar code reading performed if a lot number change
has been detected during reagent loading step (see chapter 4.5. of the STA
Compact ® Operator’s Manual).

5-4 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Calibration

Calibration Information Screen - Bar Coded Mode -

Fig. 3 - Calibration Information Screen

- Bar Coded Mode -

Complete test name

Esc Quit: returns to the graphic calibration screen

Identification of the calibration mode

Identification number of each calibration control

Complete name of each calibration control

Lot number of each calibration control used for the calibration

Minimum and maximum values for each calibration control

Original range for each calibration control

Identification number of each reagent

Complete name of each reagent

Lot number of each reagent used for the calibration. An empty box means that the reagent
has no lot number.

V 1.0 - January 96 5-5

Calibration STA COMPACT ® OPERATOR'S MANUAL

5.2.2. Description of CALIBRATION Screens: Raw Mode

Fig. 4 - CALIBRATION Screen: Raw Mode

➊ Complete test name

➋ Esc Options: this key opens the following window:

Run Controls
Print

Quit

* Run Controls: modifies the calibration control ranges if those have been defined
and runs them (F10 key).

* Print: (only possible if STA Compact ® is in stand-by mode). Printout of the calibration
screen as defined above.

* Quit: returns to CALIBRATION screen (test list).

➌ Identification of the calibration mode

➍ Date and Time of validation for the calibration controls if those are used. Otherwise, empty.

➎ Calibration control results given in the primary unit:

– None : the calibration controls have not been defined;

– xxx : waiting for calibration control results;
– —— : calibration controls are running;
– results displayed in white : calibration control results are validated in normal conditions;
– results displayed in red : calibration control results are validated although those were
and preceded by an asterisk out of range
If the calibration controls are used:
❻ Identification number of each calibration control

❼ Complete name of each calibration control

5-6 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Calibration

➑ Lot number of each calibration control used for the calibration

➒ Minimum and maximum values for each calibration control
➓ Original ranges for each calibration control

Identification number of each reagent

Complete name of each reagent.

Lot number of each reagent used for the calibration. An empty box means that the reagent
has no lot number.

5.2.3. Description of CALIBRATION Screens: Ratio Mode

Fig. 5 - CALIBRATION Screen - Ratio Mode -

➊ Complete test name

➋ Esc Options: this key opens the following window:

Modify Reference Time / Range

Quit

* Modify Reference Time / Range: modifies the Reference Time, modifies the calibration
control ranges (if used) and runs the calibration controls (if used, F10 key).

* Print: (only possible if STA Compact ® is in stand-by mode). Printout of the calibration
screen as defined above.

* Quit: returns to CALIBRATION screen (test list).

➌ Identification of the calibration mode

➍ Date and Time of validation for the calibration controls if those are used. Otherwise, empty.

➎ Reference Time Value as given by the operator

V 1.0 - January 96 5-7

Calibration STA COMPACT ® OPERATOR'S MANUAL

❻ Calibration control results given in the primary unit:

– None : the calibration controls have not been defined;

If calibration controls are used:

➐ Identification number of each calibration control

➑ Complete name of each calibration control

➒ Lot number of each calibration control used for the calibration
➓ Minimum and maximum values for each calibration control

Original ranges for each calibration control

Identification number of each reagent

Complete name of each reagent

Lot number of each reagent used for the calibration. An empty box means that the reagent
has no lot number.

ISI Value (International Sensitive Index), is only displayed if INR (International Normalized
Ratio) has been chosen as the unit.

5-8 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Calibration

5.2.4. Description of CALIBRATION Screens: Graphic Mode

Note: For this mode, there are two screens:

– graphic screen;
– information screen.

Graphic Calibration Screen - Graphic Mode -

Fig. 6 - Graphic Calibration Screen

for a Clotting Test - Graphic Mode -

V 1.0 - January 96 5-9

Calibration STA COMPACT ® OPERATOR'S MANUAL

Fig. 7 - Graphic Calibration Screen

for a Photometric Test - Graphic Mode -

➊ Complete test name

➋ Esc Options ; this key opens an OPTIONS window:

For clotting tests: For photometric tests:

OPTIONS OPTIONS

Information Information
Modify 100% Point - ISI Modify Offset
Print Print
Calibrate Calibrate
Modify Raw Data Modify Raw Data
Quit Quit

* Information: displays the second screen (Information screen) of the calibration.

* Modify 100% Point - ISI: this option is only possible for clotting tests with % as
primary unit and if the measurement scale is linear and the concentration scale is
inverse. It moves the calibration curve in a parallel direction to itself in such a way
that the calibration passes through the new point given in seconds and which
corresponds to 100%. It also gives access for ISI modification (International Sensitive
Index) if INR (International Normalized Ratio) has been chosen as the unit.

* Modify Offset: modifies if necessary the parameters of the information screen and
runs the offset correction (1-point calibration) by the F10 key.
This option is only possible for photometric tests with linear graphic mode for which
the offset corrector and the calibration controls have been defined.
It moves the calibration curve in a parallel direction to itself in such a way that it passes
through the new point defined by the offset corrector plasma.

5 - 10 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

* Print: (only possible if STA Compact ® is in stand-by mode). Printout of the two calibration
screens : graphic and information.

* Calibrate: modifies if necessary the parameters of the information screen and runs
the calibration (F10 key).

* Modify Raw Data: suppresses or modifies calibration points.

* Quit: returns to CALIBRATION screen (test list).

➌ Date and time of calibration validation

➍ Calibration control results given in the primary unit:

– none : the calibration controls have not been defined;

➎ ISI value (International Sensitive Index).

It is displayed only if INR (International Normalized Ratio) has been chosen as the unit.

➏ Value in seconds for the point corresponding to 100%. It is displayed only if it has been
modified and if the modification is possible, see above, point ➋

➐ Offset: Value in ∆ O.D. or in O.D./min for the offset corrector plasma if the latter has been
run (see description of the Modifying Offset option, chapter 5.5.2. of the STA Compact ®
Operator’s Manual)

➑ Theoretical concentration of standards in the primary unit

➒ For coagulation tests : clotting time measured in seconds. For assays in colorimetry and in
immunology : ∆ O.D. or O.D./min. A S is displayed at the left of suppressed values and a M
at the left of modified values.

➓ Value of standards after interpolation from the equation found for the calibration curve (in the
primary unit).

Graphic representation of the calibration curve.

Equation of the calibration curve.

Regression coefficient.

V 1.0 - January 96 5 - 11
Calibration STA COMPACT ® OPERATOR'S MANUAL

Calibration Information Screen - Graphic Mode -

Fig. 8 - Calibration Information Screen

for a Clotting Test - Graphic Mode -

Fig. 9 - Calibration Information Screen

for a Photometric Test - Graphic Mode -

5 - 12 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

Complete test name

Esc Quit: returns to graphic calibration screen

Identification of the calibration mode

Identification number of each standard

Complete name of each standard

Lot number of each standard used for the calibration

Dilution ratio for each standard, defined in the Test Setup menu (see chapter 3.1.2.3. of the
STA Compact ® Operator’s Manual)

Concentration of each calibration point (primary unit)

If calibration controls are used:

Identification number of each calibration control

Complete name of each calibration control

Lot number of each calibration control used for the calibration
Minimum and maximum values for each calibration control
Original ranges for each calibration control

Identification number of each reagent

Complete name of each reagent

Lot number of each reagent used for the calibration. An empty box means that the reagent
has no lot number.

Identification number, complete name and lot number of the offset corrector plasma.
For clotting tests, this box is always empty.

V 1.0 - January 96 5 - 13
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.3. Procedures for Running and Validating a Calibration

5.3.1. General Principles

Calibrations can be run:

– one by one from the calibration screen of each selected test (see chapters 5.3.3. to 5.3.6.
of the STA Compact ® Operator’s Manual);
– globally, from the CALIBRATION screen (test list), see chapter 5.3.7. of the STA Compact
® Operator’s Manual.

☞ Caution! The calibrations can be run only if the sample pipetting has not been blocked either
within the TEST STATUS screen (see description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual) or by the Stop Sample Pipetting function of the
Status sub-menu (see description, chapter 8.1.5.1. of the STA Compact ® Operator’s
Manual).
To block tests from the Global Modification menu does not block the calibrations
(see description, chapter 6.7.3. of the STA Compact ® Operator’s Manual).

The calibrations can be performed according to seven different modes:

MODE CALIBRATE

Bar coded Run the 2 calibration controls.

The reading of the parameters is performed during the
Caution: reserved to some reagent loading step (see chapter 4.5. of the STA
Diagnostica Stago tests Compact ® Operator’s Manual).

Raw Run the 2 calibration controls if those have been defined

in the TEST SETUP screens.

Ratio - Modify the Reference Time value.

- Run the 2 calibration controls if those have been
defined in the TEST SETUP screens.

Linear graphic - Run standards.

Polynomial order 2 graphic - Run the 2 calibration controls if those have been
Polynomial order 3 graphic defined in the TEST SETUP screens.
Hyperbolic graphic

To use calibration control authorizes automatic validation of calibrations. There must be 2 levels
of controls because with only one level a slope cannot be validated.

Reminder!The calibration modes as all the calibration parameters (standard definition,

calibration control definition, scales) are defined within the TEST SETUP screens
(see chapter 3.1.2. of the STA Compact ® Operator’s Manual).

Standards are run in single or in duplicate according to the determination mode chosen within
the TEST SETUP screens (see description, chapter 3.1.2. of the STA Compact ® Operator’s
Manual).

When they are defined, the calibration controls are run in single or in duplicate according to the
determination mode chosen for the sample (see Test Setup menu, chapter 3.1.1.7. of the STA
Compact ® Operator’s Manual).

5 - 14 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

As soon as calibration control results are obtained, they are compared to the acceptance range;
if those are outside of the acceptance range, STA Compact ® automatically reruns controls
according to principle described below:

First run Result(s) Automatic rerun by STA

C o n t r o l r u n in Outside the defined range Rerun of control in duplicate

single

C o n t r o l r u n in One of the 2 results is outside Rerun of control in single

duplicate the defined range

If the calibration controls are confirmed as outside the acceptance range, the calibration will
have to be validated manually.
If the operator decides to accept out of range calibration controls, the results of these will be
displayed in red, preceded by an asterisk in the related CALIBRATION screen (see chapter 5.2.
of the STA Compact ® Operator’s Manual).

Note: If the same controls are used as calibration controls and as quality controls (same
identification numbers), then the calibration control results will be integrated in the quality
control results and the clock for the quality controls will be reset while running the
calibration controls (see chapter 7.4.1. of the STA Compact ® Operator’s Manual).

If running has been requested for one or several calibrations or calibration controls, when existing
the CALIBRATION screen (test list), STA Compact ® performs a consistency check and displays
the TEST STATUS screen.
If while running a calibration, some products necessary to perform the calibration are missing
(missing or on-board but with volume or stability not usable), then the calibration will not be run,
the missing products will be displayed in red in the TEST STATUS screen and the sample
pipetting will be blocked (see description, chapter 8.1.3. of the STA Compact ® Operator’s
Manual).

5.3.2. Loading Standards and Calibration Controls

The standards and the calibration controls are loaded in the product drawer (see description,
chapter 4.6. of the STA Compact ® Operator’s Manual).

At each lot number change, the standard concentrations and the ranges of the calibration
controls for products from Diagnostica Stago are read out by means of the barcode sheets
included within each product box.
For all other products, the values have to be entered manually.

Caution! For Diagnostica Stago products, standard values and calibration control ranges are
properly dispatched in the related tests on condition that the primary unit chosen for
this test is identical to that defined on the package inserts included in each product
box (except Fibrinogen, for g/l primary unit, the values are properly dispatched even
if they are given in mg/dl on the package insert).

V 1.0 - January 96 5 - 15
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.3.3. Running and Validating Bar Coded Calibrations

The parameters of the calibration curve are read out while loading the related reagent at each
lot change. The calibration will have to be validated by two calibration controls which will insure
that your STA Compact ® has not drifted from the reference instruments.

While closing the product drawer, if the calibration controls are already loaded, in the TEST
STATUS screen, the calibration status for the related test will change to “Running”. The
calibration controls are automatically run by the STA Compact ® if the sample pipetting has not
been blocked by the operator.
Otherwise, the calibration controls will be automatically run as soon as they will be loaded and
on condition that the operator has not blocked the sample pipetting.

If the results for the two calibration controls are within the expected ranges, the calibration will
then be automatically validated, the patient assays may start. The results of the two calibration
controls are displayed in the graph part of the related calibration screen, see description, chapter
5.2.1. of the STA Compact ® Operator’s Manual.

If one or several calibration control results are outside the expected ranges, the operator will be
informed by an error message and will be offered several possibilities (see below, chapter 5.4.
of the STA Compact ® Operator’s Manual).

Note: At any time, the operator can run calibration controls on his own request, see below.

START: Screen of a bar coded calibration displayed (see description in chapter 5.2.1. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

OPTIONS

Information
Modify 100% Point - ISI
Print
Run Controls
Quit

with cursor positioned on Quit.

Press the R key (Run Controls). The following window is displayed:

Or move the cursor to Run Controls with Please enter

the ↑ key then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

Type your access code then confirm with The second screen (Information screen) is
the ↵ key. displayed (see description chapter 5.2.1. of
the STA Compact ® Operator’s Manual).

The cursor is positioned to modify if

necessary the minimum value of the range
of the first calibration control (area , see
description of this screen, chapter 5.2.1. of
the STA Compact ® Operator’s Manual).

If necessary, modify each range value, Cursor positioned on the following range
then confirm with the ↵ key. value.

Otherwise, use the ↵ key to move from a

range value to the other one.

5 - 16 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

When all range values are correct, press Back on the selected calibration screen.
the F10 key.
The calibration controls are automatically
run by STA Compact ® so long as the
consistency check does not lead to a
blocking of the sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the

abbreviation for the selected test is
d isp la ye d in y e llo w ( ca lib ra tion in
progress).

If the calibration control results are within

the expected ranges:
* automatic calibration validation;
* the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test
list)
is visualized.

If the calibration control results are not

within the expected ranges: an error
message is displayed (see chapter 5.4. of
the STA Compact ® Operator’s Manual).

V 1.0 - January 96 5 - 17
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.3.4. Running and Validating Calibrations in Raw Mode

Reminder:For raw mode, there exists no calibration; for a new lot, the only possible function is
to validate the reagent(s) of the method by running the 2 calibration controls if those
have been defined.

If both calibration control results are within the expected ranges, the calibration is
automatically validated, patient assays may start.

If calibration control results are outside the expected ranges, the operator will be
informed by an error message and will be offered several possibilities (see chapter
5.4. of the STA Compact ® Operator’s Manual).

If calibration controls are not used, the calibration status is confirmed by default.

START: Screen for a calibration in raw mode displayed (as described in chapter 5.2.2. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Run Controls
Print

Quit

with cursor positioned on Quit.

Press the R key (Run Controls). The following window is displayed:

Or move the cursor to Run Controls with Please enter

the ↓ key, then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

Type your access code then confirm with The cursor is positioned to modify if
the ↵ key. necessary the minimum value of the range
of the first calibration control (zone ➒, see
description of the screen, chapter 5.2.2. of
the STA Compact ® Operator’s Manual).

If necessary, modify each range value, The cursor is positioned on the following
then confirm with the ↵ key. range value.

Otherwise, use the ↵ key to move from a

range value to the other one.

5 - 18 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

Press the Esc key. Return to the CALIBRATION screen (test

list).

The colored square at the left of the

abbreviation of the selected test is
d isp la ye d in y e llo w ( ca lib ra tion in
progress).

If the calibration control results are within

If the calibration control results are not

within the expected ranges: an error
message is displayed (see chapter 5.4.
of the STA Compact ® Operator’s Manual).

5.3.5. Running and Validating Calibrations in Ratio Mode

Reminder:For Ratio Mode, calibrations mean entering the reference time, then validating the
reagent(s) used for the method by running the two calibration controls if they have
been defined.

If both calibration control results are within the expected ranges, the calibration is
automatically validated, patient assays may start.

5.3.5.1. Running and Validating Calibrations in Ratio Mode with Calibration Controls

START: Screen of a calibration in Ratio Mode displayed (as described in chapter 5.2.3. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Modify Reference Time / Range

Quit

with cursor positioned on Quit.

Press the M key (Modify Reference Time/ The following window is displayed:
Range).

Or move the cursor to Modify Reference Please enter

Time / Range with the ↓ key then confirm your access code:
with the ↵ key.
↵ Validate Esc Quit

V 1.0 - January 96 5 - 19
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Type your access code, then confirm with The following window is displayed:
the ↵ key.
CALIBRATION CONTROL

F10 Run
Esc Quit

The cursor is positioned to modify if

necessary the reference time (zone ➎, see
description of the screen, chapter 5.2.3. of
the STA Compact ® Operator’s manual).

Modify if necessary the value of the The cursor is positioned to modify if

reference time, then confirm with the ↵ necessary the minimum value of the range
key. of the first calibration control (zone ➓, seee
description of the screen, chapter 5.2.3 of
Otherwise, confirm with the ↵ key. the STA Compact  Operator's manual)

If necessary, modify each range value, The cursor is positioned on the following
then confirm with the ↵ key. range value.

Otherwise, use the ↵ key to move from a If INR unit has not been chosen, skip to last
range value to the other one. but one ACTIONS box below.

If INR unit has been chosen among the

secondary units, the cursor is positioned to
modify if necessary the ISI value (zone ,
see description chapter 5.2.3. of the STA
Compact ® Operator’s Manual).

Modify if necessary the ISI value, then ISI value is displayed.

confirm with the ↵ key.

When all modifications are performed, Back on the selected calibration screen.
press the F10 key.
The calibration controls are automatically
run by the STA Compact ® so long as the
consistency check does not lead to a
blocking of the sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the

abbreviation for the selected test is
di s p la y e d i n y e ll ow ( c al ib r ation in
progress).

If the calibration control results are within

If the calibration control results are not

within the expected ranges: an error
message is displayed (see chapter 5.4. of
the STA Compact ® Operator’s Manual).

5 - 20 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.3.5.2. Running and Validating Calibrations in Ratio Mode without Calibration Controls

START: Screen of a calibration in Ratio Mode displayed (as described in chapter 5.2.3. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Modify Reference Time / Range

Quit

with cursor positioned on Quit.

Press the M key (Modify Reference Time/ The following window is displayed:
Range).

Or move the cursor to Modify Reference Please enter

Time / Range with the ↓ key then confirm your access code:
with the ↵ key.
↵ Validate Esc Quit

Type your access code, then confirm with The following window is displayed:
the ↵ key.

REFERENCETIMEMODIFICATION
F10 Save
Esc Quit

The cursor is positioned to modify if

necessary the reference time value (zone
➎, see description of the screen, chapter
5.2.3. of the STA Compact ® Operator’s
Manual).

Modify if necessary the reference time If INR unit has not been chosen, jump over
value, then confirm with the ↵ key. ACTIONS box below and move to the next
one.

Otherwise, confirm with the ↵ key. If INR unit has been chosen among the
secondary units, the cursor is positioned to
modify if necessary the ISI value (zone ,
see description chapter 5.2.3. of the STA
Compact ® Operator’s Manual).

Modify if necessary the ISI value, then ISI value is displayed.

confirm with the ↵ key.

When all modifications are performed, Return to CALIBRATION screen (test list).
press the F10 key.
T h e c o l o r e d s q u a r e at le ft o f t h e
abbreviation for the selected test is
displayed in white (confirmed calibration).

V 1.0 - January 96 5 - 21
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.3.6. Running and Validating Calibrations in Graphic Mode

Reminder:For graphic mode, calibration means running standards, then calibration controls if
those have been defined.

If both calibration control results are within the expected ranges, the calibration is
automatically validated, patient assays may start.

If calibration controls are not used, the calibration validation will be done manually
(see chapter 5.4. of the STA Compact ® Operator’s Manual).

5.3.6.1. Running and Validating Calibrations in Graphic Mode with Calibration Controls

START: Screen of a calibration in graphic mode displayed (as described in chapter 5.2.4. of
the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. For clotting tests, the following window is
displayed:

OPTIONS

Information
Modify 100% Point - ISI
Print
Calibrate
Modify Raw Data
Quit

For photometric tests, the following window

is displayed:

OPTIONS

Information
Modify Offset
Print
Calibrate
Modify Raw Data
Quit

In both cases, the cursor is positioned on

Quit.

Press the C key (Calibrate). The following window is displayed:

Or move the cursor to Calibrate with the¯ Please enter

↑ key, then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

5 - 22 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

Type your access code, then confirm with The second screen (Information screen) is
the ↵ key. displayed, (see description chapter 5.2.4.
of the STA Compact ® Operator’s Manual).

The cursor is positioned to modify, if

necessary, the concentration for the first
standard (zone , see description of this
screen, chapter 5.2.4. of the STA Compact ®
Operator’s Manual).

Modify if necessary the concentration of For all standards having the same
the first standard, then confirm with the ↵ identification number, the concentrations
key. are automatically calculated and displayed.

Otherwise, confirm with the ↵ key. The cursor is positioned on the second
standard.

If other standard concentrations have to be For all standards having the same
modified, modify them, then confirm with identification number, the concentrations
the ↵ key. are automatically calculated and displayed.

The cursor is positioned on the next

standard or on the minimum value of the
range of the first calibration control.

Move the cursor to the minimum value of The cursor is positioned on the next range
the range of the first calibration control, value.
modify, if necessary, each range value,
then confirm with the ↵ key.

Otherwise, use the ↵ key to move from a

range value to the other one.

When all parameters are set, confirm with Back on the selected calibration screen.
the F10 key.
The standards, then the calibration controls
are automatically run by the STA Compact ®
so long as the consistency check does not
lead to a blocking of the sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the

abbreviation for the selected test is
d isp la ye d in y e llo w ( ca lib ra tion in
progress).

If the calibration control results are within

If the calibration control results are not

within the expected ranges: an error
message is displayed (see chapter 5.4. of
the STA Compact ® Operator’s Manual).

V 1.0 - January 96 5 - 23
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.3.6.2. Running and Validating Calibrations in Graphic Mode without Calibration Controls.

START: Screen of a calibration in graphic mode displayed (as described in chapter 5.2.4. of
the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. For clotting tests, the following window is
displayed:

OPTIONS

Information
Modify 100% Point - ISI
Print
Calibrate
Modify Raw Data
Quit

For photometric tests, the following window

is displayed:

OPTIONS

Information
Modify Offset
Print
Calibrate
Modify Raw Data
Quit

In both cases, the cursor is positioned on

Quit.

Press the C key (Calibrate). The following window is displayed:

Or move the cursor to Calibrate with the− Please enter

↑key, then confirm with the ↵ key. your access code:

¿ Validate Esc Quit

Type your access code, then confirm with The second screen (Information screen) is
the ↵ key. displayed, (see description chapter 5.2.4.
of the STA Compact ® Operator’s Manual).

The cursor is positioned to modify if

necessary the concentration for the first
standard (zone , see description of this
screen, chapter 5.2.4. of the STA Compact ®
Operator’s Manual).

Otherwise, confirm with the ↵ key. The cursor is positioned on the second
standard.

If other concentrations have to be modified, For all standards having the same
modify them, then confirm with the ↵ key. identification number, the concentrations
a r e a u t o m a t i c a l l y c a l c u l a t e d a nd
displayed.

5 - 24 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

When all parameters are set, press the Back on the selected calibration screen.
F10 key.
The standards are automatically run by the
STA Compact ® so long as the consistency
check does not lead to a blocking of the
sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the

abbreviation for the selected test is
dis play ed in y ellow (calibration in
progress).

When the calibration is complete, an

information message is displayed.

See chapter 5.4. of the STA Compact ®

Operator’s Manual.

5.3.7. Running Several Calibrations

Note: This function is reserved to tests predefined by Diagnostica Stago because it implies
that no operator’s intervention is requested to modify standard concentrations and/or
calibration control concentrations. And this is only possible for the bar coded products
(standards, controls) for which the value transfer is automatically performed.

Note: Calibration running requests are refused in the following conditions:

– raw mode without calibration controls;

– ratio mode without calibration controls or if the reference time has not been defined;
– calibration status is “in progress” or “to be validated”.

START: CALIBRATION screen (test list) displayed, (as described in chapter 5.1.2. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

For each test whose calibration is The letter S is displayed in grey at the left
requested, move t h e c u r s o r t o its of each test abbreviation for which the
abbreviation then press the F1 key. calibration has been requested.

Note: To cancel a running request, press

again the F1 key.

When all required calibrations are marked The following window is displayed:
with the letter S, press the F10 key.
Please enter
your access code:

↵ Validate Esc Quit

V 1.0 - January 96 5 - 25
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Type your access code, then confirm with On CALIBRATION screen (test list):
the ↵ key. * the S letters disappear;
* the colored squares at the left of the
abbreviations for the selected tests are
displayed in yellow (calibration in
progress).

The standards and the calibration controls

(if necessary) are automatically run by the
STA Compact ® so long as the consistency
check does not lead to a blocking of the
sample pipetting.

Press the ESC key. The TEST STATUS screen is displayed

(see description, chapter 8.1.3. of the
STA Compact ® Operator’s Manual).

If the calibration control results are within

If the calibration control results are not

within the expected ranges: an error
message is displayed (see chapter 5.4. of
the STA Compact ® Operator’s Manual).

If calibration controls are not used, please

see chapter 5.4. of the STA Compact ®
Operator’s Manual.

5 - 26 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.4. Procedures to Observe in Case of Calibration not Automatically

Confirmed

There are two cases:

– calibration not confirmed because of calibration controls out of range;

– calibration not confirmed due to absence of calibration controls.

Note: For calibrations with graphic mode, as long as the reagent lot numbers have not
changed, the new calibration curve is displayed in yellow and the previous one in grey.
Raw data, curve equation and regression coefficient are those of the new calibration
curve.

5.4.1. Displayed Messages in Case of Calibration not Automatically Confirmed

In both cases (see above), the operator is informed by a message:

– calibration controls out of range:

MEASURING MANAGEMENT

Error 05.06.06
.
CALIBRATION CONTROL
.
Control out of limits
for the test xxx

Esc = continue

xxx: Abbreviation of the related test.

– absence of controls:

MEASURING MANAGEMENT

Error 05.06.10
.
CALIBRATION
.
Calibration is ready to be confirmed
for the test xxx

Esc = continue

xxx: Abbreviation of the related test.

V 1.0 - January 96 5 - 27
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.4.2. Description of CALIBRATION NOT CONFIRMED Windows

These windows are displayed while selecting a calibration whose status is to be confirmed (blue
square displayed at the left of the test abbreviation).

5.4.2.1. Description of the CALIBRATION NOT CONFIRMED Window (out of Range Controls)

Fig. 10 - CALIBRATION NOT CONFIRMED Window

(out of Range Controls)

➊ Calibration control identification numbers

➋ Calibration control results. The primary unit is recalled.

The results out of range are displayed in red.

➌ Recall of the minimum and maximum ranges for each calibration control

➍ List of possible functions:

*Confirm: validates out of range calibration controls, (see chapter 5.4.3. of the STA Compact ®
Operator’s Manual);

*Rerun Controls: reruns calibration controls, (see chapter 5.4.4. of the STA Compact ®
Operator’s Manual);

*Restore Previous Curve: returns to previous calibration if no lot change was detected (see
chapter 5.4.7. of the STA Compact ® Operator’s Manual);

*Rerun Calibration: reruns calibration, (see chapter 5.4.8. of the STA Compact ® Operator’s
Manual);

*Cancel the Calibration: cancels calibration in case of lot change (see chapter 5.4.9. of the
STA Compact ® Operator’s Manual);

*Postpone Decision: returns to CALIBRATION screen (test list).

The name of the functions are displayed in blue when available, otherwise in grey.
The cursor is positioned on Postpone Decision.

5 - 28 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.4.2.2. Description of the CALIBRATION NOT CONFIRMED Window (Absence of Controls)

CALIBRATION NOT CONFIRMED

Absence of Controls

Confirm
Modify then Confirm
Restore Previous Curve
Rerun
Cancel the Calibration

Postpone Decision

➊ List of possible functions:

*Confirm: manually validates the calibration, (see chapter 5.4.5. of the STA Compact ®
Operator’s Manual);

* Modify then Confirm: modifies some raw data then manually validates the calibration
(see chapter 5.4.6. of the STA Compact ® Operator’s Manual);

*Restore Previous Curve: returns to previous calibration if no lot change was detected (see
chaper 5.4.7. of the STA Compact ® Operator’s Manual);

*Rerun Calibration: reruns calibration, (see chapter 5.4.8. of the STA Compact ® Operator’s
Manual);

*Cancel the Calibration: cancels calibration in case of lot change (see chapter 5.4.9. of the
STA Compact ® Operator’s Manual);

*Postpone Decision: returns to CALIBRATION screen (test list).

The name of the functions are displayed in blue when available, otherwise in grey.
The cursor is positioned on Postpone Decision.

5.4.3. Confirming out of Range Calibration Controls

☞ Caution! This procedure is only possible if the operator knows the access code to accept out
of range controls, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

Reminders: • if for a selected test, the calibration controls are confirmed while out of range,
then results of these controls will be displayed in red in the related
CALIBRATION screen (see chapter 5.2. of the STA Compact ® Operator’s
Manual).

• In the CALIBRATION NOT CONFIRMED window (out of Range Controls),

the out of range controls are displayed in red and the ranges of each control
are recalled (see description, chapter 5.4.2.1. of the STA Compact ®
Operator’s Manual).

START: Screen of the selected calibration is displayed with the CALIBRATION NOT
CONFIRMED window (out of Range Control)ioned on Postpone Decision (see
description, chapter 5.4.2.1. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Move the cursor to Confirm with the ↓ key, The following window is displayed:
then confirm with the ↵ key.
Please enter
your access code:

↵ Validate Esc Quit

V 1.0 - January 96 5 - 29
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Type your access code, then confirm with The selected calibration screen is updated
the ↵ key. for:
- the date;
- the time;
- the calibration control results.

Out of range calibration control results are

displayed in red.

Press the Esc key then confirm with the ↵ Return to CALIBRATION screen (test list).
key.
The colored square at the left of the test
a b b r e v ia t io n is d is pl ay e d in w h it e
(confirmed calibration).

5.4.4. Rerun Controls

Reminder!This function is possible only if calibration controls have been defined.

START: Screen of the selected calibration is displayed with the CALIBRATION NOT
CONFIRMED window (out of Range Controls), the cursor is positioned on
Postpone Decision (see description, chapter 5.4.2.1. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Reload if necessary, products (reagents, The following window is displayed:

standards, diluents, controls).

Move the cursor to Rerun Controls with Please enter

the ↓, then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

Type your access code, then confirm with T he C A L I B R A TI ON C ON TR O L

the ↵ key. RUNNING window appears.

Controls are rerun by STA Compact ® so

long as the consistency check does not
lead to a blocking of the sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the test

abbreviation is displayed in yellow
(calibration in progress).

Press the Esc key. The TEST STATUS screen is displayed

(see description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

5 - 30 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.4.5. Manually Confirming a Calibration Curve

☞ Caution! This procedure is possible only if calibration controls were not used.

START: Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED
window (Absence of Controls), the cursor is positioned on Postpone Decision
(see description, chapter 5.4.2.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Move the cursor to Confirm with the ↓ key, The following window is displayed:
then confirm with the ↵ key.

Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The CALIBRATION NOT CONFIRMED
the ↵ key. (A b s e n ce of C on t ro ls) w i n d ow
disappears.

Press the Esc key then confirm with the Return to CALIBRATION screen (test list).
↵ key.

The colored square at the left of the test

a bb r e v i at io n i s di s p la y e d i n w h it e
(confirmed calibration).

5.4.6. Modifying then Confirming a Calibration Curve

☞ Caution! This procedure is possible only if the operator knows the access code to critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

Reminder: This procedure is possible only if calibration controls were not used.

START: Screen of the selected calibration is displayed with the CALIBRATION NOT
CONFIRMED window (Absence of Controls), the cursor is positioned on Postpone
Decision (see description, chapter 5.4.2.2. of the STA Compact ® Operator’s
Manual).

ACTIONS RESULTS

Move the cursor to Modify/Validate with The following window is displayed:

the ↑ key, then confirm with the ↵ key.

CORRECTION Del Delete

Ins Restore
F10 Confirm
Esc Quit

The cursor is positioned on the first

calibration data point.

To delete values: A S in yellow is displayed at the left of the

Move the cursor to the value(s) to be deleted value(s).
deleted with the ↓ key, then press the
Delete key.

V 1.0 - January 96 5 - 31
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Caution! Depending on the regression The deleted value is displayed in grey.

type, a minimum number of
calibration points should
remain:
* 2 for linear regression;
* 4 for polynomial 2nd order
regression;
* 5 for hyperbolic regression;
* 6 for polynomial 3rd order
regression.

Note! A value can be restored with the

Insert key.

To modify values: The modified value(s) are displayed.

Move the cursor to the value(s) to be
modified with the ↓ key, then proceed to
the modification(s) and confirm with the ¿
key.

When all modifications are done, press the The following window appears:
F10 key.
Please enter
your access code:

↵ Validate Esc Quit

Type your access code then confirm with The new calibration is recalculated then the
the ↵ key following are displayed: the new calibration
curve, the new equation and the new
regression coefficient.

A S in yellow is displayed near deleted

value(s) and a M in yellow near modified
value(s).

Deleted values are still displayed in grey.

Press the Esc key then the ↵ key. Return to CALIBRATION screen (test list).

The colored square at the left of the test

a b b r e v ia t io n is d is pl ay e d in w h it e
(confirmed calibration).

5.4.7. Restoring Previous Calibration

☞ Caution! This procedure is possible only if the operator knows the access code to critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

Reminder: This procedure is only possible for calibration curves performed with the same
reagent lot numbers as previously used.

5 - 32 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

START: Screen of the selected calibration displayed with the CALIBRATION NOT
CONFIRMED window (out of Range Controls or Absence of Controls), the cursor
is positioned on Postpone Decision.

ACTIONS RESULTS

Move the cursor to Restore Previous The following window is displayed:

Curve with the ↑ key, then confirm with the
↵ key. Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The CALIBRATION NOT CONFIRMED window
the ↵ key. disappears.

The screen of the selected calibration is

d is p la y e d a ga in w it h t h e p r e v ious
calibration and all associated parameters
( e q u a t i o n , r e g r e s s i o n c o e f f ic ie n t ,
measured v a lu e s , i nt e r p ol at e d
concentrations).

5.4.8. Rerun Calibration

Note: This option is not available for bar coded calibrations.

START: Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED
window (out of Range Controls or Absence of Controls), the cursor is positioned
on Postpone Decision.

ACTIONS RESULTS

Load if necessary products (reagents, The following window is displayed:

controls, calibrators, diluents).

Move the cursor to Rerun Calibration with Please enter

the ↑ key, then confirm with the ↵ key. your access code

↵ Validate Esc Quit

Type your access code, then confirm with T h e CALIBRATION RUNNING window
the ↵ key. disappears.

The standards (and the calibration controls

if those are used) are rerun by STA
Compact ® so long as the consistency
check does not lead to a blocking of the
sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the test

abbreviation is displayed in yellow
(calibration in progress).

Press the Esc key. The TEST STATUS screen is displayed

(see description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

V 1.0 - January 96 5 - 33
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.4.9. Cancelling Calibration

Reminder: This option is only available if the calibration has been run with new reagent lot
numbers.

START: Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED
window (out of Range Controls or Absence of Controls), the cursor is positioned
on Postpone Decision.

ACTIONS RESULTS

Move the cursor to Cancel the Calibration The CALIBRATION NOT CONFIRMED window
with the ↑ key, then confirm with the ↵ key. disappears.

The calibration curve disappears.

The colored square at the left of the test

abbreviation is displayed in red (calibration
not calibrated).

5 - 34 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.5. Other Possible Interventions on Confirmed Calibrations

5.5.1. Modification of 100% Point

☞ Caution! This procedure is only possible if the operator knows the access code allowing critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

Reminder!This option is only possible for clotting tests with % as primary unit and if the
measurement scale is linear and the concentration scale is inverse.
It moves in a parallel direction to itself the calibration curve in such a way that the
calibration passes through the new point given in seconds and which corresponds
to 100%.

START: Screen of the selected calibration displayed with the OPTIONS window (cursor
positioned on Quit).

ACTIONS RESULTS

Move the cursor to Modify 100% Point - The following window is displayed:
ISI with the ↑ key, then confirm with the ↵
key. Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The following window is displayed:
the ↵ key.

MODIFICATION

F10 Save
Esc Quit

The cursor is positioned on the entry zone

for:

* the ISI value if INR has been chosen

as the unit (zone 5 , see descriptions of
the CALIBRATION screen (bar coded
mode)
chapter 5.2.1. of the STA Compact ®
Operator’s Manual and of the
CALIBRATION screen (graphic mode),
chapter 5.2.4. of the STA Compact ®
Operator’s Manual).

* modifying the 100% point (zone ❻, see

descriptions of the CALIBRATION
screen
(bar coded mode), chapter 5.2.1. of the
STA Compact ® Operator’s Manual and
of the CALIBRATION screen (graphic
mode), chapter 5.2.4. of the STA
Compact ® Operator’s Manual).

In this last case, skip the ACTIONS

box below.

V 1.0 - January 96 5 - 35
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

If INR has been chosen as unit, move the The cursor is positioned on the entry zone
cursor with the ↓ key. for:

* modifying the 100% point (zone ❻,

see descriptions of the CALIBRATION
screen (bar coded mode), chapter 5.2.1.
of the STA Compact ® Operator’s
Manual and of the CALIBRATION screen
(graphic mode) chapter 5.2.4. of the STA
Compact ® Operator’s Manual).

Type in seconds the time corresponding to The screen of the selected calibration is
the 100% of the lab, then confirm with the displayed with the previous calibration
↵ key. drawn in stippled yellow and the new one
in yellow.

In the curve equation, the slope is kept and

the Y intercept is recalculated.

The interpolated concentrations are

recalculated.

Save the modifications with the F10 key. If calibration controls are defined, they are
automatically run by STA Compact ® so
long as the consistency check does not
lead to a blocking of the sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

If calibration controls are defined, the

colored square at left of the abbreviation of
the selected test is displayed in yellow
(calibration in progress).

If calibration controls are not defined, the

colored square at left of the abbreviation of
the selected test is displayed in white
(confirmed calibration).

Press the Esc key. If calibration controls are defined, the TEST
STATUS s c r e e n i s d i s p la y ed (see
description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

If calibration controls are not defined, return

to TEST PANEL.

5 - 36 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

5.5.2. Modifying Offset

Reminder!This function is only possible for photometric (chromogenic or immunological) tests

with linear graphic mode and if the offset corrector plasma and the calibration
controls have been defined. It moves the calibration curve in parallel direction to itself
in such a way that it passes through the new points defined by the offset corrector
plasma.

START: CALIBRATION screen displayed for a photometric test with the OPTIONS window
(cursor positioned on Quit).

ACTIONS RESULTS

Move the cursor to Modify Offset with the The following window is displayed:
↓ key, then confirm with the ↵ key.

Please enter your

access code:

↵ Validate Esc Quit

Type your access code, then confirm with A screen similar to the information screen
the ↵ key. is displayed (see description, chapter 5.2.4.
of the STA Compact ® Operator’s Manual)
with information on the offset corrector
plasma instead of information on the
standards.

The cursor is positioned to modify if

necessary the concentration of the offset
corrrector plasma.

Modify if necessary the concentration of The cursor is positioned on the minimum

the offset corrector plasma then confirm value of the range of the first calibration
with the ↵ key. control.

Modify if necessary each range value, the The cursor is positioned on the following
confirm with then ↵ key. range value.

When all parameters are set, press the F10 Back on the selected calibration screen.
key.
The offset corrector plasma and the
calibration controls are automatically run by
STA Compact ® so long as the consistency
check does not lead to a blocking of the
sample pipetting.

Press the Esc key. Return to CALIBRATION screen (test list).

The colored square at the left of the

abbreviation for the selected test is
d i s p l a ye d in y e llo w ( ca lib ra tio n in
progress).

Press the Esc key. The TEST STATUS screen is displayed

(see description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

Note: After confirmation of the calibration:

– the new curve is displayed in yellow;
– the previous curve is displayed in stippled yellow;
– the interpolated concentrations are recalculated;
– the reading corresponding to the offset corrector plasma is displayed near
Offset (zone ➐ , see description, chapter 5.2.4. of the STA Compact ®
Operator’s Manual).

V 1.0 - January 96 5 - 37
Calibration STA COMPACT ® OPERATOR'S MANUAL

5.5.3. Modifying Measures

☞ Caution! This procedure is possible only if the operator knows the access code to critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

Reminder: This procedure is also possible on calibrations whose status is to be confirmed

(see procedure, chapter 5.4.6. of the STA Compact ® Operator’s Manual).

START: CALIBRATION screen displayed with OPTIONS window (cursor positioned on Quit).

ACTIONS RESULTS

Move the cursor to Modify Raw Data with The following window is displayed:
the ↑ key, then confirm with the ↵ key.
Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The following window is displayed:
the ↵ key.
CORRECTION Del Delete
Ins Restore
F10 Confirm
Esc Quit

The cursor is positioned on the first

calibration point.

To delete values: A S in yellow is displayed at the left of the

Move the cursor to the value(s) to be deleted value (s).
deleted with the ↑ key, then press the
Delete key.

Caution! Depending on the regression Deleted values are displayed in grey.

type, a minimum number of
calibration points should
remain:
* 2 for linear regression;
* 4 for polynomial 2nd order
regression;
* 5 for hyperbolic regression;
* 6 for polynomial 3rd order
regression.
Otherwise, the curve will
disappear.

Note! A value can be restored with the

Insert key.

To modify values: The modified value (s) are displayed.

Move the cursor to the value(s) to be
modified with the ↓ key, then proceed to
the modification(s) and confirm with the ↵
key.

5 - 38 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

When all modifications are done, validate The new calibration is recalculated then the
with F10 key. following are displayed: the new calibration
curve, the new equation, and the new
regression coefficient.

A S in yellow is still displayed near deleted

value(s) and a M in yellow appears near
modified value(s)

Deleted value(s) are still displayed in grey.

Press the Esc key, then the ↵ key. Return to CALIBRATION screen (test list).

If calibration controls are defined, they are

automatically run by STA Compact ® so
long as the consistency check does not
lead to a blocking of the sample pipetting.

Press the Esc key. If calibration controls are defined, the TEST
STATUS s c r e e n i s d i s p la y e d (see
description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

If calibration controls are not defined, return

to TEST PANEL.

5.5.4. Printout of a Calibration Curve

☞ Caution! This function is possible only if the STA Compact ® is in stand-by mode (no
measurements in progress) and if all printouts of patient files previously generated
have been performed.

Reminder:Depending on the calibration mode, one or two calibration screens are printed (for
details, see calibration screen descriptions, chapters 5.2.1. to 5.2.4. of the STA
Compact ® Operator’s Manual).

START: Screen of selected calibration displayed with OPTIONS window (cursor positioned
on Quit).

ACTIONS RESULTS

Press the P key (Print). The following window is displayed:

Or move the cursor to Print with the ↑ key, PRINTOUT

then confirm with the ↵ key.

EXECUTE

Printer Test
Form Feed

Quit

with cursor positioned on EXECUTE.

V 1.0 - January 96 5 - 39
Calibration STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the ↵ key (Execute). The “PRINTING” indication is displayed at

the foot of the screen.

Depending on the calibration mode, one or

two pages are printed as described in
chapters 5.2.1. to 5.2.4. of the STA
Compact ® Operator’s Manual.

An asterisk is printed at left of each out of

range calibration control result.

When the printout is complete, press the The printout window disappears.
Esc key.
Return to selected calibration screen.

5.5.5. Modifying the ISI Value

☞ Caution! This procedure is only possible if the operator knows the access code allowing critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual).

The modification of the ISI value (International Sensitive Index) is performed differently
depending on calibration modes:

– for Ratio modes, access is given through the Modify Reference Time function (see
description, chapter 5.3.5. of the STA Compact ® Operator’s Manual).
– for bar coded or graphic modes, see procedure below.

START: Screen of the selected calibration displayed with the OPTIONS window (cursor
positioned on Quit).

ACTIONS RESULTS

Move the cursor to Modify100% Point - ISI The following window is displayed:
with the ↓ key, then confirm with the ↵ key.
Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The following window is displayed:
the ↵ key.
MODIFICATION

F10 Save
Esc Quit

The cursor is positioned on the entry zone for

the ISI value (zone ➎, see descriptions of the
CALIBRATION screen (bar coded mode),
chapter 5.2.1. of the STA Compact ®
Operator’s Manual and of the CALIBRATION
screen (graphic mode), chapter 5.2.4. of
the STA Compact ® Operator’s Manual).

5 - 40 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Calibration

ACTIONS RESULTS

Type the new ISI value, then confirm with The new ISI value is displayed near ISI
the F10 key. Coefficient (zone ➎, see descriptions of the
CALIBRATION screen (bar coded mode),
chapter 5.2.1. of the STA Compact ®
Operator’s Manual and of the CALIBRATION
screen (graphic mode), chapter 5.2.4. of
the STA Compact ® Operator’s Manual).

5.5.6. Viewing the Information Screen

Reminder:This function is available only when there are two screens to define a calibration: bar
coded mode or graphic mode (linear, hyperbolic, polynomial 2nd order or polynomial
3rd order).

START: Screen of selected calibration displayed with the OPTIONS window, cursor is
positioned on Quit.

ACTIONS RESULTS

Move the cursor to Information with the The information screen is displayed (see
↓ key, then confirm with the ↵ key. description of this screen, chapters 5.2.1.
a nd 5 . 2 .4 . o f t he STA Com pac t ®
Operator’s Manual).

V 1.0 - January 96 5 - 41
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 6

6. PATIENT FILE MANAGEMENT 1

6.1. Generalities 1

6.2. Confirmation/Printout/Transmission Menu 2

6.2.1. Access to the Confirmation/Printout/Transmission Menu 2
6.2.2. Description of the CONFIRMATION/PRINTOUT Screen 3
6.2.3. To Select Files (CONFIRMATION/PRINTOUT Screen) 4
6.2.3.1. Access to the FILE SELECTION Window 4
6.2.3.2. Description of the FILE SELECTION Window
(CONFIRMATION/PRINTOUT Screen) 4
6.2.3.3. Change the Selection (CONFIRMATION/PRINTOUT Screen) 5
6.2.4. To Quit the CONFIRMATION/PRINTOUT Screen 6

6.3. Processing of a Patient File of the Working File 7

6.3.1. Access to a Given File 7
6.3.2. Description of the FILE PROCESSING Screen for the Working File 7
6.3.3. Description of the Possible Processings 10
6.3.4. Procedure to Process a Patient File 11
6.3.5. Add Complementary Information 11
6.3.6. Add a Non-Standard Note 12
6.3.7. Use a Standard Note 12
6.3.8. To Create or Modify Standard Notes 12

6.4. To Transmit Results 13

6.4.1. Conventions 13
6.4.2. Generalities 13
6.4.3. On-Line Transmission 13
6.4.4. Batch Uploading of Patient Files 14
6.4.4.1. Access the FILE TRANSMISSION Window 14
6.4.4.2. Description of the FILE TRANSMISSION Window 14
6.4.4.3. To Run a Transmission of Patient Files 15

6.5. Patient File Printout 16

6.5.1. Generalities 16
6.5.2. Access the PRINTOUT Window 16
6.5.3. Description of the PRINTOUT Window 17
6.5.4. Description of the Printout Parameters 17
6.5.5. To Define the Printout Parameters 18
6.5.6. On-Line Printout 18
6.5.7. Printout of a Patient File Selection 19
6.5.8. Printout Examples 20

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Table of Contents, Chapter 6 STA COMPACT ® OPERATOR'S MANUAL

6.6. To Delete Patient Files from the Working File 22

6.6.1. Access the FILE DELETION Window 22
6.6.2. Description of the FILE DELETION Window 23
6.6.3. Procedure of Deletion of the Patient Files from the Working File 24
6.6.4. Procedure to Delete the Entire Working File 25

6.7. Global File Modification 26

6.7.1. Access the FILE MODIFICATION Screen 26
6.7.2. Description of the FILE MODIFICATION Screen 26
6.7.3. To Block or to Unblock Tests 27
6.7.4. To Rerun or Delete Tests 28

6.8. Customer Printout of Validated Files 30

6.8.1. Generalities 30
6.8.2. Access to CUSTOMER PRINTOUT OF VALIDATED FILES Screen 30
6.8.3. Description of the CUSTOMER PRINTOUT OF VALIDATED FILES Screen 31
6.8.4. To Define the Customer Printout Parameters 32
6.8.4.1. Customer Printout Format 32
6.8.4.2. Access to PRINTOUT CONFIGURATION Screens 34
6.8.4.3. First PRINTOUT CONFIGURATION Screen (Customer Printout Menu) 34
6.8.4.4. Second PRINTOUT CONFIGURATION Screen (Customer Printout Menu) 35
6.8.4.5. Modification of the Customer Printout Definition Parameters 36
6.8.5. To Select Files for the Customer Printout 37
6.8.5.1. Access to the FILE SELECTION Window (Customer Printout) 37
6.8.5.2. Description of the FILE SELECTION Window (Customer Printout) 37
6.8.5.3. Change the Selection (Customer Printout) 38
6.8.6. Printout of a File Selection (Customer Printout) 39

6.9. Download of Working Lists 40

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6. PATIENT FILE MANAGEMENT

6.1. Generalities

STA Compact ® manages one file containing 600 Patient Files: the Working File.

As soon as a Patient file is created, it is stored into the Working File whether the corresponding
sample tube is loaded or not in the sample drawer.

On the Patient files of the Working File, the following operations are possible:
– confirmation of tests or file;
– file printout;
– file transmission to a host computer;
– deletion of tests within Patient files;
– rerun of tests;
– insertion of tests in files;
– change a file from non-urgent to STAT and vice versa;
– deletion of a file selection;
– addition of complementary information (name, first name, ... ) on the files.

All these operations can be performed directly from the TEST PANEL screen by positioning the
cursor on the desired file or from the Files menu, CONFIRMATION/PRINTOUT screen.

Tests may also be blocked, unblocked, deleted or rerun as a global action (see chapter 6.7.of
the STA Compact ® Operator’s Manual ).

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.2. Confirmation/Printout/Transmission Menu

Note: This menu allows access to Patient files of the Working File.

6.2.1. Access to the Confirmation/Printout/Transmission Menu

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading Files (...) - Halt

with the cursor on Status.

Press the F key (Files). The Files menu is displayed:

Confirmation /Printout/Transmission
Delete Patient Files
Customer Printout

w i t h t h e c u r s or o n Confirmation/
Printout/Transmission.

Press the ↵ key. The CONFIRMATION/PRINTOUT screen

is displayed with the list of selected files
(see description, chapter 6.2.2. of the STA
Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.2.2. Description of the CONFIRMATION/PRINTOUT Screen

Fig. 1 - CONFIRMATION/PRINTOUT Screen

❶ Available keys:

↵ Processes the file on which the cursor is positioned (see chapter 6.3. of the STA
Compact ® Operator’s Manual);
F6 Prints out a selected patient file;
Esc Options, this key opens the following window:

Change File Selection

Transmit
Print

Quit

* Change File Selection: selects a group of Patient files with filtering if necessary
(see chapter 6.2.3. of the STA Compact ® Operator’s Manual);
* Transmit: transmits the file selection (see chapter 6.4.4. of the STA Compact ®
Operator’s Manual);
* Print: prints out the file selection (see chapter 6.5.7. of the STA Compact ®
Operator’s Manual) ;
* Quit: returns to the TEST PANEL.

❷ Complementary information (name, first name ... see description chapter 8.2.3.3. of the STA
Compact ® Operator’s Manual) for the file on which the cursor is positioned.

❸ Recall of color code signification as well as the number of files corresponding to each
category for the entire Working File.

❹ Selected File List:

* Two letters (T and P) confirm if the transmission (T) or the printout (P) have been
done. The two letters may not appear at all (no transmission done nor printout) or
simultaneously (file transmitted and printed out).
* A colored square provides the status of each file:
– Blue: Confirmed file.
– White: Complete file.
– Red: Complete file with error.
– Yellow: Incomplete file (including non loaded tubes and loaded tubes not yet run).

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.2.3. To Select Files (CONFIRMATION/PRINTOUT Screen)

6.2.3.1. Access to the FILE SELECTION Window

START: CONFIRMATION/PRINTOUT screen displayed (see chapter. 6.2.1. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTATS

Press the Esc key (Options). The following sub-menu is displayed:

Change File Selection

Transmit
Print

Quit

with the cursor on Quit.

Press the C key (Change File Selection). The FILE SELECTION window is displayed
(see description, chapter 6.2.3.2. of the
Or move the cursor to Change File STA Compact ® Operator’s Manual) with
Selection with the ↓ key then confirm with cursor positioned in area ➊.
the ↵ key.

6.2.3.2. Description of the FILE SELECTION Window (CONFIRMATION/PRINTOUT Screen)

Fig. 2 - FILE SELECTION Window

❶ Identification of the first file of the file selection

❷ Identification of the last file of the file selection

❸ Available functions:

F1 Displays “Start” corresponding to the first file of the file listing in chronological order in
the Working File.

F2 Displays “End of File” corresponding to the last file of the chronological file listing in
the Working File.

F3 Selects the files with the cursor in the displayed list.

F10 Executes the selection and displays it.

Esc Returns to the CONFIRMATION/PRINTOUT screen.

↑↓ Moves the cursor to the different parameters.

❹ Filtering prefix identification

❺ Category of the required files, the ≤ key allows display or deletion of the colored square
corresponding to the category of the required file. This functions allows a better filtering.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.2.3.3. Change the Selection (CONFIRMATION/PRINTOUT Screen)

START: FILE SELECTION window displayed (see description on chapter 6.2.3.2. of the STA
Compact ® Operator’s Manual).

ACTIONS RESULTS

Type the identification of the first file of the The identification of the first file of the list is
desired selection then confirm with the ↵ displayed in area ➊ or “Start ” is displayed
key. in area ➊ and the cursor is positioned in
area ➋ (see description of the FILE
Or press the F1 key to display “Start” SELECTION window, chapter 6.2.3.2. of
(corresponding to the first file (the oldest) the STA Compact ® Operator’s Manual).
of the Working File).

Or press the F3 key to select the files with

the cursor. In this case, use the moving
cursor keys to move it to the required file,
then confirm with the ↵ key.

Caution: It is impossible to use F1/F2

keys with the F3 key.

Type the identification of the last file of the The identification of the last file of the list is
desired selection then confirm with the ↵ displayed in area ➋ or “End of File” is
key. displayed in area ➋ and the cursor is
positioned in area ➁ (see description of the
Or press the F2 key to display “End of File” F I L E S E LE C T IO N window, chapter
(corresponding to the last file (the latest) of 6.2.3.2. of the STA Compact ® Operator’s
the Working File). Manual).

To select the last file with the cursor, use

the moving cursor keys to move it to the
required file, then confirm with the ↵ key.

Caution: It is impossible to use F1/F2

keys with the F3 key.

To filter: type the prefix identification, then Filtering prefix identification displayed in
confirm with the ↵ key. (If the cursor is not the area ➁ (if defined) with the cursor
positioned in area ➁, move it with the positioned in area ➋ (see description of the
↓ key). F I L E S E LE C T IO N window, chapter
6.2.3.2. of the STA Compact ® Operator’s
Or type the first number(s) or letter(s) of the Manual).
patient files identification, then confirm
with the ↵ key.

O r leave the area empty (no prefix

definition) and confirm with the ↵ key.

To improve the filtering, use the ↵ key to The colored square appears near the type
display a colored square near the type of of desired files.
desired files. If the square is already
displayed, move the cursor with the ↓ key.

If a type of file is not desired, use the ↵ key The colored square disappears.
to remove the colored square.

When all the parameters of the desired The new selection is displayed on the
selection are set, press the F10 key. CONFIRMATION/PRINTOUT screen (see
description, chapter 6.2.2. of the STA
Compact ® Operator’s Manual).

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.2.4. To Quit the CONFIRMATION/PRINTOUT Screen

START: CONFIRMATION/PRINTOUT screen displayed, (see chapter 6.2.1. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Press the Esc key (Options). The following sub-menu is displayed:

Change File Selection

Transmit
Print

Quit

with cursor positioned on Quit.

Confirm with the ↵ key. If no test has been added in patient files,
back on the TEST PANEL screen.

If tests have been added or rerun in patient

files, TEST STATUS screen is displayed (see
chapter 8.1.3. of the STA Compact ®
Operator’s Manual) .

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.3. Processing of a Patient File of the Working File

6.3.1. Access to a Given File

There are two options:

– from TEST PANEL;
– from the CONFIRMATION/PRINTOUT screen on condition that the desired test is
present in the list of selected files, otherwise a new file selection will have to be
performed (see chapter 6.2.3. of the STA Compact ® Operator’s Manual).
START: - TEST PANEL screen displayed or;
- CONFIRMATION/PRINTOUT screen displayed with the list of selected files (see
chapter 6.2.1. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Move the cursor to the desired file with Cursor positioned on the desired file.
the ↑ and ← keys (cursor positioned on
the first file of the list).

Confirm with the ↵ key. The screen FILE PROCESSING for the
Working File is displayed (see description
below).

6.3.2. Description of the FILE PROCESSING Screen for the Working File

Fig. 3 - FILE PROCESSING Screen

(from CONFIRMATION/PRINTOUT Screen)

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

Fig. 4 - FILE PROCESSING Screen

(from TEST PANEL)

❶ Recall of the chosen filtering.

➋ Recall of the validation limits, for the test on which the cursor is positioned.

➌ Raw data (time or O.D./min. or ∆ O.D.) and final results in primary units for each
determination and for the mean, for the test on which the cursor is positioned.

In case of duplicate determination, STA Compact ® compares the difference between the
two results by means of the PRECISION parameter defined within the page 1 of 3 of the
TEST SETUP screens (see description, chapter 3.1.1.7. of the STA Compact ® Operator’s
Manual).
If the calculated difference is greater than the defined one, STA Compact ® automatically
reruns a third test, compares the three results and keeps the best result pair.

❹ Available functions (see description below, chapter 6.3.3. of the STA Compact ® Operator’s
Manual).

❺ File status:

∗ On the left of the line:

– CONFIRM: all the tests of the file are done and confirmed;
– COMPLETE: all the tests of the file are done but some of them have to be confirmed;
– COMPLETE/Error: all the tests of the file are done but some of them have an error;
– INCOMPLETE: some tests or all tests on the file have to be done, the file has no test (file
with teleloading), or file without tube;

∗ On the center of the line:

– STAT is displayed for the STAT samples.

∗ On the right of the line:

– Transmit: the file has been transmitted;
– Printed: the file has been printed;
– Transmit/Printed: the file has been transmitted and printed out.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

❻ File Identification:

* On the left of the first line:

Identification number with color codes allowing to distinguish the different status (identical to
those used on the TEST PANEL):
– White : O.K. (tube loaded or not);
– Yellow : STAT sample (tube loaded or not);
– Grey : File for which a tube has been loaded but the list of tests is unknown (waiting
for teleloading from the host computer);
– Green : A liquid level detection error has been detected;
– Red : An error has been detected on one or several tests.

* On the right of the first line:

For Patient files with loaded tube: position of the latter in the sample drawer.
For Patient files without tube: empty area.

* On the second line:

Complementary information (name, first name, ... ), see description of the Global Options
menu (chapter 8.2.3.3. of the STA Compact ® Operator’s Manual).
These information are whether transmitted by the host computer or defined by moving the
cursor to this area (see procedure, chapter 6.3.5. of the STA Compact ® Operator’s Manual).

❼ Test list of the file. An asterisk appears on the left for tests with alarm(s) (see point
hereafter).

❽ For each test, mean of the result, in the primary unit

❾ For each test, mean of the result, in the first secondary unit

❿ For each test, mean of the result, in the second secondary unit

For each test, status of the result:

– blocked;
– erased;
– waiting;
– in process;
– to confirm;
– tech. err. (technical error);
– Value > Max. (equivalent to > V max. displayed on the TEST PANEL, see description, chapter
2.2.1. of the STA Compact ® Operator’s Manual);
– Value < Min. (equivalent to < V min. displayed on the TEST PANEL, see description, chapter
2.2.1. of the STA Compact ® Operator’s Manual);
– Dev. > tol. [deviation > precision (only for double determination)];
– linearity;
– QNS (quantity of plasma not sufficient);
– rerun;
– confirm.

Note: For each test, the areas ➐, ➑, ➒, ➓, and are displayed with a specific color
depending on the result status:

– blue : confirm;
– white : to confirm;
– black : waiting;
– grey : rerun;
– red : error.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

For the test on which the cursor is positioned, type of the alarm code if necessary:

-A result validated with Time > Max. Time;

-B not used;
-C Quality controls out of range detected by STA Compact ® or not done;
-D Quality controls out of range but validated by the operator;
-E Liquid Level Detection for needle # 3 not controlled (see Global Options menu,
chapter 8.1.2. of the STA Compact ® Operator’s Manual);
-F Liquid Level Detection for needle # 2 not controlled (see Global Options
menu, chapter 8.1.2. of the STA Compact ® Operator’s Manual);
-G Liquid Level Detection for needle # 1(sample) not controlled (see Global Options
menu, chapter 8.1.2. of the STA Compact ® Operator’s Manual);
-H result in primary unit limited to printout limit values (see chapter 3.1.3.3. of the STA
Compact ® Operator’s Manual);
-I result obtained after redilution (this redilution is defined in TEST SETUP screens, see
chapter 3.1.1.9. of the STA Compact ® Operator’s Manual):
-J result rerun by the operator;
-K temperature of product drawer out of range;
-L preventive maintenance not done for the syringe.

Note: The alarms are classified by priority order (from A to L). The first one appears totally,
the other ones are represented by alphabetical codes and can be viewed by pressing
the * key.

Adds or selects a note among the standard ones by pressing the F9 key (see procedure , on
chapters 6.3.6. to 6.3.8. of the STA Compact ® Operator’s Manual).

6.3.3. Description of the Possible Processings

PgUp Page Up: the previous file is displayed, Page Down: the next file is displayed;
PgDn

Esc List: Returns to the CONFIRMATION/PRINTOUT screen (not available from TEST
PANEL);

Esc Quit: Returns to TEST PANEL, if no tests have been inserted or rerun; otherwise
displays the TEST STATUS screen if one or several tests have been inserted or rerun
(see description of this screen, chapter 8.1.3. of the STA Compact ® Operator’s Manual),
not available from CONFIRMATION/PRINTOUT screen;

F1 Confirm File - All results with status to confirm are changed to status confirm. Upon
saving (F10 key), if all result status are confirm, then the file status is changed to
CONFIRM;

F2 Accept Test - The test status on which the cursor is positioned is changed to confirm
if its original status allows it: to confirm or Dev. > tol. or Value > max. (when it is
equivalent to time > T max.);

F3 Rerun Test - The test on which the cursor is positioned will be rerun. Its status is
changed to rerun.
For duplicate determination, the tests are rerun in duplicate. The current results have
to be printed out because they will disappear.
For single determination, the previous value is stored and a new single determination
is run. The parameter PRECISION defined on the first page of the TEST SETUP screens
(see description, chapter 3.1.1.7.of the STA Compact ® Operator’s Manual) is used to
compare both results. If the difference is greater than the defined one, then the STA
Compact ® automatically reruns the test a third time, compares the three results and
keeps the best pair of results.

Notes: • While returning to the TEST PANEL, the STA Compact ® will then
automatically display the TEST STATUS screen (see chapter 8.1.3. of the
STA Compact ® Operator’s Manual).

• Rerun tests is also possible as a global option (see chapter 6.7. of the STA
Compact ® Operator’s Manual).

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F4 Delete Test - The test on which the cursor is positioned will be deleted. Its status is
changed to erased.

Note: Delete tests is also possible as a global option (see chapter 6.7. of the STA
Compact ® Operator’s Manual).

F5 Insert Test - Accesses a TEST SELECTION window. Move the cursor to the required
test and confirm with the ≤ key. This is only possible for tests which are not already
selected.

Note: While returning to the TEST PANEL, the STA Compact ® will then
automatically display the TEST STATUS screen (see chapter 8.1.3. of the
STA Compact ® Operator’s Manual).

F6 Print - The displayed patient file is printed.

F10 Save - Records all the modifications applied to the displayed patient file.

F11 Save +Transmit - Records all the modifications applied to the displayed patient file and
transmits the file. For more details on transmission, (see chapter 6.4. of the STA
Compact ® Operator’s Manual).

F12 STAT/NORMAL - Changes a non-urgent file to a STAT file or vice versa.

↑ ↓ Moves cursor.

6.3.4. Procedure to Process a Patient File

– Access to Patient file either from TEST PANEL or from CONFIRMATION/PRINTOUT

screen (see chapter 6.3.1. of the STA Compact ® Operator’s Manual).
– Use the different possible commands (see description, in chapters 6.3.3. and 6.3.5.
to 6.3.8. of the STA Compact ® Operator’s Manual).

6.3.5. Add Complementary Information

Reminder: Only the complementary information as defined in the Global Options menu
can be added (see chapter 8.2.3.3. of the STA Compact ® Operator’s Manual).

START: A FILE PROCESSING screen is displayed.

ACTIONS RESULTS

Use the ↑ key to move the cursor to area The cursor is positioned on the first area
❻, (see description, chapter 6.3.2. of the available for complementary information
STA Compact ® Operator’s Manual). (zone ❻, see description chapter 6.3.2.
of the STA Compact ® Operator’s
Manual).

Type the desired information then confirm Cursor moves to following area.
with the → key.

When all complementary information are Cursor moves back to the first test of the
defined, confirm with the ↵ key. test list (zone ➐, see description, chapter
6.3.2. of the STA Compact ® Operator’s
Manual).

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6.3.6. Add a Non-Standard Note

START: A FILE PROCESSING screen displayed.

ACTIONS RESULTS

Use the ↓ key to move the cursor to the Cursor positioned in “Note” area (zone
“Note” area (zone , see chapter 6.3.2. , see chapter 6.3.2. of the STA
of the STA Compact ® Operator’s Compact ® Operator’s Manual).
Manual).
The message “Optional notes - F9:
using standard notes” is displayed at
the foot of the screen.

Type the required note with the keyboard Cursor is positioned back on the last test
then confirm with the ↵ key. of the list of the tests of the patient file.

6.3.7. Use a Standard Note

START: A FILE PROCESSING screen displayed, with the cursor in the “Note” area (area ,
see description, chapter 6.3.2. of the STA Compact ® Operator’s Manual) and the
message “Optional notes - F9 = using standard notes” is displayed at the foot of
the screen.

ACTIONS RESULTS

Press the F9 key. The list of standard notes is displayed.

Move the cursor to the desired note with The list of standard notes disappears and
the ↓ key then confirm with the ↵ key. the chosen note is displayed in “Note”
zone (zone , see description, chapter
6.3.2. of the STA Compact ® Operator’s
Manual).

Press the ↵ key. Cursor is positioned back on the last test

of the list of the tests of the patient file.

6.3.8. To Create or Modify Standard Notes

START: A FILE PROCESSING screen displayed, with the cursor in the “Note” field (field
, see description, chapter 6.3.2. of the STA Compact ® Operator’s Manual) and the
message “Optional notes - F9 = using standard notes” is displayed at the foot of
the screen.

ACTIONS RESULTS

Press the F9 key. The list of standard notes is displayed.

Move the cursor with the ↓ key to a free Cursor positioned in the desired field.
field to create a standard note or to an
existing note to modify it.

Press the F2 key, type the required text, The new (or modified) note is now
then confirm with the ↵ key. included in the list of standard notes.

Press the Esc key. Back on the FILE PROCESSING screen.

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6.4. To Transmit Results

6.4.1. Conventions

All results are transmitted according to an ASTM protocol. For more information, see document
“User Interface RS 232-C STA Compact ® ASTM”, Cat. No. 28062.

All results are transmitted with two codes. The first one defines the result status (see description,
chapter 6.3.2. point of the STA Compact ® Operator’s Manual), and the second one the type
of alarm if necessary (see description, chapter 6.3.2. point of the STA Compact ® Operator’s
Manual).

6.4.2. Generalities

According to the conventions defined above, there are three options for transmitting results:

– Real Time Transmission: results are sent test by test as soon as they are obtained (see
description below, chapter 6.4.3. of the STA Compact ® Operator’s Manual).

– Uploading File by File with the F11 key from different FILE PROCESSING screens, access
by the CONFIRMATION /PRINTOUT screen or by the TEST PANEL screen (see chapter
6.3.3. of the STA Compact ® Operator’s Manual);

– Batch uploading (see description below, chapter 6.4.4. of the STA Compact ® Operator’s
Manual).

To check the transmission and the transmission options, see chapter 9. of the STA Compact ®
Operator’s Manual.

6.4.3. On-Line Transmission

When the On-line transmission is actuated, the results are sent test by test as soon as they are
obtained according to the conventions defined in chapter 6.4.1. of the STA Compact ® Operator’s
Manual.

Procedure to actuate the On-line transmission:

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading Files (...) - Halt

with cursor on Status.

Press the ↵ key. The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting NO
On-Line Transmission NO
On-Line Printout NO

with cursor on System.

Move the cursor to On-Line The option On-Line Transmission No

Transmission No with the ↓ key then changes to On-Line Transmission Yes.
confirm with the ↵ key.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.4.4. Batch Uploading of Patient Files

This procedure allows transmission of patient files of a given selection to the host computer.
It is first necessary to proceed to a file selection: see chapters 6.2.3. of the STA Compact ®
Operator’s Manual.

6.4.4.1. Access the FILE TRANSMISSION Window

Access this window by the Files menu from the CONFIRMATION/PRINTOUT screen (see access,
chapter 6.2.1. of the STA Compact ® Operator’s Manual).

START: CONFIRMATION/PRINTOUT screen displayed

ACTIONS RESULTS

Press the Esc key (Options). The following window is

displayed:F"Helvetica"P10

Change File Selection

Transmit
Print

Quit

with cursor positioned on Quit.

Press the T key (Transmit). The FILE TRANSMISSION window is displayed

(see description below).
Or move the cursor to Transmit with the ↓
key, then confirm with the ↵ key.

6.4.4.2. Description of the FILE TRANSMISSION Window

Fig. 5 - FILE TRANSMISSION Window

➊ Allows to choose between:

– transmits only files never transmitted (option displayed by default);

– transmits all files, including those already transmitted.

➋ Identification of the Patient file currently transmitted

➌ Number of Patient files remaining to transmit

❹ Available functions:

F10 runs the Patient file transmission (or starts it again if it was stopped)

Esc returns to list of selected files or stops the transmission

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.4.4.3. To Run a Transmission of Patient Files

START: FILE TRANSMISSION window displayed (see chapter 6.4.4.1. of the STA Compact
® Operator’s Manual).

ACTIONS RESULTS

To include patient files which have been The identification of the patient files being
already transmitted, press the Y key, then transmitted are displayed near Processed
confirm with the F10 key; otherwise, press File (zone ➋ of the FILE TRANSMISSION
the F10. window) and the number of files remaining
to transmit near Rest (zone ➌ of the FILE
TRANSMISSION window, see description
above, chapter 6.4.4.2. of the STA
Compact ® Operator’s Manual).

The message “TRANSMITTING” then

“TRANSMISSION COMPLETE” a r e
displayed above Processed File (zone ➋
of the FILE TRANSMISSION window, see
description above, chapter 6.4.4.2. of the
STA Compact ® Operator’s Manual).

To stop the current transmission, press the The message “TRANS. INTERRUPTED”
Esc key. is displayed above Processed File (zone
➋ of the FILE TRANSMISSION window,
see description, chapter 6.4.4.2. of the STA
Compact ® Operator’s Manual).

The F10 key restarts the transmission.

The Esc key returns to the list of selected

files.

When the transmission is done, press the Returns to the list of selected files.
Esc key.
The letter T is displayed in front of the
i d e n t i f i c a t i o n o f e ac h f ile ac t u a lly
transmitted.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.5. Patient File Printout

6.5.1. Generalities

There are three options for printing out patient files:

– On-Line Printout: the patient files are printed file by file as soon as they are completed
(see description, chapter 6.5.6. of the STA Compact ® Operator’s Manual);

– Printout of an individual file by the F6 key:

* directly from the CONFIRMATION/PRINTOUT screen for the file corresponding to the
position of the cursor (see chapter 6.2.2. of the STA Compact ® Operator’s Manual),

* or from the FILE PROCESSING screens accessible whether from the CONFIRMATION/
PRINTOUT screen or from the TEST PANEL screen (see chapter 6.3.3. of the STA Compact ®
Operator’s Manual);

– Printout of a selection of files (see chapter 6.5.7. of the STA Compact ® Operator’s
Manual).

For all these cases, the printout parameters are defined from the PRINTOUT window accessible
as soon as the Print option is selected (see below, chapters 6.5.2. to 6.5.5. of the STA Compact ®
Operator’s Manual).
To check the printer parameters or the printer connection, see chapter 9. of the STA Compact ®
Operator’s Manual.

In addition, patient file printout can also be custom-built (see description, chapter 6.8. of the STA
Compact ® Operator’s Manual).

6.5.2. Access the PRINTOUT Window

This window is accessible within the Files menu from the CONFIRMATION/PRINTOUT screen (see
access, chapter 6.2.1. of the STA Compact ® Operator’s Manual).

START: CONFIRMATION/PRINTOUT screen displayed.

ACTIONS RESULTS

Press the Esc key (Options). The following window is displayed

Change File Selection

Transmit
Print

Quit

with cursor positioned on Quit.

Press the P key (Print). The PRINTOUT window is displayed, see

description below.
Or move the cursor to Print by pressing
the ↓ key, then confirm with the ↵ key.

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6.5.3. Description of the PRINTOUT Window

Fig. 6 - PRINTOUT Window

❶ Prints only the unprinted files from a selection of Patient files (see procedure in chapter
6.5.7. of the STA Compact ® Operator’s Manual)

❷ Prints all the selected files (see chapter 6.5.7. of the STA Compact ® Operator’s Manual)

❸ Defines the printout parameters, (see chapters 6.5.4. and 6.5.5. of the STA Compact ®
Operator’s Manual)

❹ Returns to the list of selected files

❺ Printout parameters

6.5.4. Description of the Printout Parameters

Three parameters allow definition of the printout (area ➋ of the PRINTOUT window) :
– Mode : all files or single file;
– Quality : standard or presentation;
– Page Length : defined by a number of lines.
– All files mode: The name of the lab is printed on top of each page whose length depends
on the parameter “Page Length”. All the patient files are printed one after each another
like a table.
Single file mode: For each patient file, the name of the lab is printed.
The page change occurs according to the length defined by the “Page Length”
parameter.
– Standard Quality: Allows a rapid printout which does not print some special character
forms.
Presentation Quality: Allows a better quality printout but is much slower.
– Page Length: Defines the length of a patient file (single file mode) or the length of one
table of patient files (all files mode) without taking into account the real length of paper.
To avoid frequent cuts in files, apply the following principle :
– 1 inch = 6 lines
– 11" paper = 66 lines in a real page
– To print 2 patient files per page = set Page Length to 33 lines
– To print 3 patient files per page = set Page Length to 22 lines
If a printing file is cut:
– the message “Continued: next page” is printed on the lower right corner of the first part;
– the complete patient file identification (including the complementary information) is
recalled on top of the second part;
– the message “CONTINUED” is printed just above the patient file identification for the
second part.

Recall : The lab name is defined within the Global Options menu, (see chapter 8.2.2.2. of
the STA Compact ® Operator’s Manual).

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.5.5. To Define the Printout Parameters

START: PRINTOUT window displayed with cursor positioned on Quit (see chapter 6.5.2. of
the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the P key (Printer Setup). The following window is displayed:

Or move the cursor to Printer Setup by

pressing the ↓ key twice, then confirm with
the ↵ key.

with cursor positioned on all files or on

single file.

To modify a given parameter: move the For “Mode” parameter, definition changes
cursor on it with the ↓ key then, confirm from all files to single file or inversely.
with the ↵ key.
F or “Quality” param eter, definition
changes from standard to presentation or
inversely.

For “Page Length” parameter, cursor is

positioned on the number of lines (see
description of the printout parameters in
chapter 6.5.4. of the STA Compact ®
Operator’s Manual).

Type with the keyboard the number of Parameters are displayed.

desired lines then confirm with the ↵ key.

When all the printout parameters are set, Back on PRINTOUT window.
press the Esc key.

6.5.6. On-Line Printout

When On-Line Printout is actuated, the patient files are printed as soon as all the tests of the
file are completed whether results are concerned or not by errors or alarms.
The printing is performed according to the printer parameters defined from the PRINTOUT
window (see description, chapters 6.5.2. to 6.5.5. of the STA Compact ® Operator’s Manual).

Procedure to actuate the On-line printout:

START : TEST PANEL displayed.

ACTIONS RESULTS

Press the Esc key (menu). The Main Menu is displayed:

Status Loading Files (...) - Halt

with cursor on Status.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

ACTIONS RESULTS

Press the ↵ key. The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting NO
On-Line Transmission NO
On-Line Printout NO

with cursor on System.

Move the cursor to On-Line Printout No The option On-Line Printout No

with the ↓ key, then confirm with the ↵ changes to On-Line Printout Yes.
key.

6.5.7. Printout of a Patient File Selection

Note: If the On-Line Printout has been chosen, this option is available only if the STA Compact ®
is in stand-by mode (no measurement in progress) and if all the printouts previously
scheduled have been done.
If the On-Line Printout has not been chosen, this option is always available.

With this procedure, all patient files of a given selection are printed; it is first necessary to proceed
to file patient selection (see, chapter 6.2.3. of the STA Compact ® Operator’s Manual).

START: PRINTOUT window displayed (see procedure, chapter 6.5.2. of the STA Compact ®
Operator’s Manual), with cursor positioned on Quit.

ACTIONS RESULTS

Change t h e p r i n t o u t p a r a m e t e r s if A window is displayed in the upper left

necessary, (see chapters 6.5.4. and 6.5.5. corner of the screen. This window indicates
of the STA Compact ® Operator’s Manual). the identification of the file being processed
as well as the number of files remaining to
print.

Depending on the required patient files: At the same time, the file printout starts.
* All the files not yet printed,
press the ↓ key (Unprinted Files) then
confirm with the ↵ key.
* All the selected files:
press the ↓ key to All Files, then confirm
with the ↵ key.
To stop the current printout, press the The files already processed are being
Esc key. printed.

Then, the printout stops.

When all files are printed. Automatic return to the list of selected files.

The letter P is printed in front of the

identification of each file actually printed.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.5.8. Printout Examples

Fig. 7 - Printout of a Patient File -

Single File Mode - Presentation Quality

GENERAL HOSPITAL ➊
HAEMOSTASIS LABORATORY

20/11/1994 - 11:31:40 ➋ Page 1

ANALYSIS RESULTS CODE NORMAL RANGE

96 Garrisson Tim ➌

PTT 35.0 sec. ❺ 1.00 Ratio ❻ 35.0 Ref. T. ➐ ➑ Confirm ➒ 28.0 ... 40.0 sec.

* Fibrinogen ❹ 259 mg/dl 21.7 sec. Confirm 200 ... ➓ 400 mg/dl

ALARM Fibrinogen Result : rerun test

Fig. 8 - Printout of a Patient File -

All Files Mode - Standard Quality

GENERAL HOSPITAL ➊
HAEMOSTASIS LABORATORY

20/11/1994 - 11:35:30 ➋ Page 1

ANALYSIS RESULTS CODE NORMAL RANGE

96 Garrisson Tim ➌

PTT 35.0 sec. ❺ 1.00 Ratio 35.0 Ref. T. Ñ Confirm ➒ 28.0 ... 40.0 sec.
❻M ➐✰✘
* Fibrinogen ❹ 259 mg/dl 21.7 sec. Confirm 200 ... ➓ 400 mg/dl

ALARM Fibrinogen Result : rerun test

75 Brown Peter ➌

PTT 35.0 sec. ❺ 1.00 Ratio ➋ 35.0 Ref. T. ➐ ➑ Confirm ➒ 28.0 ... 40.0 sec.
Fibrinogen ❹ 268 mg/dl 20.9 sec. Confirm 200 ... ➓ 400 mg/dl

82 Jefferson Thomas ➌

PTT 35.0 sec. ❺ 1.00 Ratio ❻ 35.0 Ref. T. ➐ ➑ Confirm ➒ 28.0 ... 40.0 sec.
Fibrinogen ❹ 307 mg/dl 18.1 sec. Confirm 200 ... ➓ 400 mg/dl

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

❶ Name of the lab, as defined within the Global Options menu (see chapter 8.2.2.2. of the
STA Compact ® Operator’s Manual).

➋ Date and time of the printout.

➌ Patient file identification including the complementary information (name, first name, ...) if
necessary. On the second line, the standard notes if necessary.

❹ Name of the test. It is preceded by an asterisk (*) if the test is concerned by one or several
alarms.

❺ Result in primary unit

❻ Result in the first secondary unit if necessary

❼ Result in the second secondary unit if necessary

❽ Result in the third secondary unit if necessary

Note: The areas ❻, ➐, ➑, ➒ are empty if the result is not confirmable.

❾ Result status:

– blocked;
– waiting;
– in process;
– to confirm;
– error (corresponds to following results: technical error, Value > Max., Value < Min.,
Dev. > tol, linearity, quantity for plasma not sufficient);
– confirm.

❿ Usual values for each test as defined within the Test Setup menu (see chapter 3.1.3.2. of
the STA Compact ® Operator’s Manual).

List of alarms presented by test (see definition, point of chapter 6.3.2. of the STA
Compact ® Operator’s Manual).

Page Number - In “Single File” mode, the page number starts at 1 with each File printout.

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6.6. To Delete Patient Files from the Working File

Note: This option is only accessible if the STA Compact ® is in stand-by mode (no
measurements in progress) and if the printouts previously scheduled have been done.

Note: When the Working File is saturated (more than 600 records), the operator is requested
to delete the oldest file whose sample tube has been removed.

☞ Caution! The Patient file deleted by this procedure are definitively lost.

Recall: The option Delete Files from the Working File is also possible upon switching on the
STA Compact ® (see procedure, chapter 2.1.4. of the STA Compact ® Operator’s
Manual). But in this case, no selection is possible.

6.6.1. Access the FILE DELETION Window

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading Files (...) - Halt

with cursor on Status.

Press the F key (Files). The following sub-menu is displayed:

Confirmation/Printout/Transmission
Delete Patient Files
Customer Printout

w i t h t h e c u r s o r p o s itio n e d o n
Confirmation/Printout/Tran smission.

Press the D key (Delete Patient Files). The FILE DELETION window is displayed (see
description below, chapter 6.6.2. of the
Or move the cursor to Delete Patient Files STA Compact ® Operator’s Manual).
with the ↓ key then confirm with the ↵ key.

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6.6.2. Description of the FILE DELETION Window

Fig. 9 - FILE DELETION Window

➊ Identification of the first file of the selection

➋ Identification of the last file of the selection

➌ Prefix identification

❹ Category of the required files identified by a colored square:

– Blue : Confirmed file (Yes/No);

– White : Complete file (Yes/No);
– Red : Complete file with error (Yes/No)
– Yellow : Incomplete file (Yes/No).

By default, all the options are set to Yes (colored square is displayed).

❺ Available functions:

F3 selects the files with the cursor in the displayed list;

F4 deletes the entire Working File;

F10 displays the list of selected files then deletes the selection;

↓ ↑ moves the cursor to different parameters;

Esc returns to TEST PANEL screen.

❻ List of selectable files (selection procedure in progress) or list of selected files (selection
procedure done).

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6.6.3. Procedure of Deletion of the Patient Files from the Working File

START: FILE DELETION window displayed (see chapter 6.6.1. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Press the F3 key. The message “Please select the First File”
is displayed.

All the available patient files of the Working

File are displayed in zone ❻ (see above
FILE DELETION window description,
chapter 6.6.2. of the STA Compact ®
Operator’s Manual).

Use the moving cursor keys to move it to The message “Please select the Last File”
the required file, then confirm with the ↵ is displayed.
key.

Identification of the first file is recalled.

Use the moving cursor keys to move it to The FILE DELETION window is displayed with
the required file, then confirm with the the cursor positioned near Prefix (zone ➌)
↵ key. and the identifications of the first selected
file and of the last selected file displayed in
zones ➊ and ➋ (see description of the FILE
DELETION window, chapter 6.6.2. of the
STA Compact ® Operator’s Manual).

Type the prefix identification then confirm Prefix identification displayed in the area ➌
with the ↵ key. and cursor positioned on area ➁ (see
d e s c r i pt io n of th e FILE DELETION
Or type the first number(s) or letter(s) of the window, chapter 6 . 6 . 2 . o f t h e S TA
required patient file identifications, then Compact® Operator’s Manual).
confirm with the ↵ key.

Or l e a v e this area empty (no prefix

identification) and confirm with the ↵ key.

If a type of file is not desired, use the ↓ key The colored square disappears.
to move the cursor to it, then confirm with
the ↵ key to remove the colored square.

When all the parameters of the desired The following window appears furtively:
selection are set, press the F10 key.
Research in progress
Please, wait.

The list of selected files is displayed in zone 6

(see description of the FILE DELETION window,
chapter 6.6.2. of the STA Compact ®
Operator’s Manual).

The message “Please, type YES to

confirm” is displayed.

Type the letters: YES then confirm with the The patient files are deleted from zone 6
↵ key. (see description of the FILE DELETION window,
chapter 6.6.2. of the STA Compact ®
Operator’s Manual).

Press the Esc key. Return to TEST PANEL screen.

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6.6.4. Procedure to Delete the Entire Working File

START: FILE DELETION window displayed (see chapter 6.6.1. of the STA Compact ®
Operator’s Manual).

ACTIONS RESULTS

Press the F4 key. All the available patient files of the Working
File are displayed in zone ❻ (see above
FILE DELETION window description,
chapter 6.6.2. of the STA Compact ®
Operator’s Manual).

The message “Please, type YES t o

confirm” is displayed.

Type the letters: YES then confirm with the All files of the Working File are deleted from
↵ key. zone ❻ (see description of the FILE DELETION
window, chapter 6.6.2. of the STA Compact ®
Operator’s Manual).

Press the Esc key. Return to TEST PANEL screen.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.7. Global File Modification

This menu allows to block or to unblock tests, to rerun or to delete tests for a given selection.

6.7.1. Access the FILE MODIFICATION Screen

START: TEST PANEL displayed.

ACTIONS RESULTS

Press the / key (Options) of the keypad The following window is displayed:
(right side of the keyboard).
Help
File Modification

Quit

with the cursor positioned on Quit.

Press the F key (File Modification). The FILE MODIFICATION screen is displayed
(see description below, chapter 6.7.2. of
Or move the cursor to File Modification with the STA Compact ® Operator’s Manual).
the ↓ key, then confirm with the ↵ key.

6.7.2. Description of the FILE MODIFICATION Screen

Fig. 10 - FILE MODIFICATION Screen

❶ F1 Change: opens the following window which allows to choose the type of file modification
to apply:

Block
Unblock
Rerun
Delete

* Block: blocks tests in pending status:

* Unblock: unblocks blocked tests;
* Rerun: reruns tests for the selected files;
* Delete: deletes tests for the selected files.
Note: There is only one type of modification possible at one time.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

❷ Identification of the type of modification chosen. The first letter of the name of the
modification is displayed in yellow.

❸ F2 selects the patient files on which the file modification will be applied (see procedure
below, chapter 6.7.4. of the STA Compact ® Operator’s Manual). This function is not
available when the chosen file modifications are Block or Unblock.

❹ Identification of the first file of the selection.

❺ Identification of the last file of the selection

❻ Available functions:

↵ applies the chosen file modification (or cancels it) for the test corresponding to the
position of the cursor;

F10 executes the chosen file modification;

Esc returns to TEST PANEL screen.

❼ Complete name of the test corresponding to the position of the cursor.

❽ List of the abbreviations of the available tests. The letter B (Blocked) is displayed in grey at the
left of the tests currently blocked. When chosing the application of the file modification, a letter
is displayed in yellow at the left of the selected tests:

B for : block
U for : unblock
R for : rerun
D for : delete

Note: The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red

background at the foot of the screen when the sample pipetting is blocked whether:

– voluntarily by the operator (Stop Sample Pipetting function, see description in

chapter 8.1.5.1. of the STA Compact ® Operator’s Manual);
– or automatically by the STA Compact ® after the consistency check; if the required
assays cannot be done.

6.7.3. To Block or to Unblock Tests

Note: The Block or Unblock options concern the tests of all patient files present in the
Working File and the quality control automatic (periodic) running function. It does not
concern the calibrations nor the calibration controls. Consequently, the file selection is
not available.
Block is only possible for pending tests and Unblock for blocked tests.
Indeed, the operator can force any quality control running for a blocked test by using the Run
function of the Quality Control menu (see chapter 7.3. of this STA Compact ®
Operator’s Manual).

Note: After having unblocked tests, while returning to the TEST PANEL, the STA Compact®
automatically displays the TEST STATUS screen (see description, chapter 8.1.3. of
the STA Compact ® Operator’s Manual)

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

START: FILE MODIFICATION screen displayed (see procedure, chapter 6.7.1. of the STA
Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the F1 key. The following window is

displayed:

Block
Unblock
Rerun
Delete

with the cursor positioned on Block

To block, press the ↵ key. Block is displayed in the ACTION area

(zone ➋, see description of the FILE
MODIFICATION screen, chapter 6.7.2. of
the STA Compact ® Operator’s Manual).

To unblock, press the U key (Unblock) or Unblock is displayed in the ACTION area
move the cursor to Unblock with the ↓ key, (zone ➋, see description of the FILE
then confirm with the ↵ key. MODIFICATION screen, chapter 6.7.2. of
the STA Compact ® Operator’s Manual).

The cursor is positioned on the first test in

zone ➑ (see description of the FILE
MODIFICATION screen, chapter 6.7.2. of
the STA Compact ® Operator’s Manual).

Use the moving cursor keys to move it to A letter is displayed in yellow at the left of
each related test then mark each test with the marked test; B for Block or U for
the ↵ key. Unblock.

When all parameters are set, press the The file modification is applied.
F10 key.
For the Block function, the TEST PANEL is
displayed:
* The message Block appears in red
replacing results for the tests concerned
by the Block option.

For the Unblock function, the TEST

STATUS screen is displayed (see
description, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

6.7.4. To Rerun or Delete Tests

Reminder: For duplicate determination, the tests are rerun in duplicate. The current
results have to be printed out because they will disappear.

For single determination, the previous value is stored and a new single
determination is run. The parameter PRECISION defined on the first page of
the TEST SETUP screens (see description chapter 3.1.1.7.of the STA
Compact ® Operator’s Manual) is used to compare both results. If the
difference is greater than the defined one, then the STA Compact ®
automatically reruns the test a third time, compares the three results and
keeps the best pair of results.

Note: After having chosen to rerun globally several tests, while returning to the TEST PANEL,
the STA Compact ® automatically displays the TEST STATUS screen (see description,
chapter 8.1.3. of the STA Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

START: FILE MODIFICATION screen displayed (see procedure, chapter 6.7.1. of the STA
Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the F1 key. The following window is displayed:

Block
Unblock
R erun
Delete

with the cursor positioned on Block.

To rerun tests, press the R key (Rerun) or Rerun is displayed in the ACTION area
move the cursor to Rerun with the ↓ key, (zone ➋, see description of the FILE
then confirm with the ↵ key. MODIFICATION screen, chapter 6.7.2. of the
STA Compact ® Operator’s Manual).

To delete tests, press the D key (Delete) Delete is displayed in the ACTION area
or move the cursor to Delete with the ↓ key, (zone ➋, see description of the FILE
then confirm with the ↵ key. MODIFICATION screen, chapter 6.7.2. of the
STA Compact ® Operator’s Manual).

Press the F2 key. The TEST PANEL is displayed.

The message “Please select the First File”

is displayed.

Use the moving cursor keys to move it to The message “Please select the Last File”
the required file then confirm with the ↵ is displayed.
key.
The identification of the first selected file is
recalled.

Use the moving cursor keys to move it to The FILE MODIFICATION screen is displayed
the required file then confirm with the ↵ with the cursor positioned on the first test
key. of the list of available tests (zone ➑) and the
identifications of the first selected file and
of the last selected file are displayed in
zones ➁ and ➋ (see description of the
FILE MODIFICATION screen, chapter
6.7.2. of the STA Compact ® Operator’s
Manual).

Use the moving cursor keys to move it to A letter is displayed in yellow at the left of
each related test, then confirm with the ↵ each marked test: R for Rerun, D for
key. Delete.

Press the F10 key. The file modification is applied.

For the Rerun function, the TEST STATUS

screen is displayed (see description,
chapter 8.1.3. of the STA Compact ®
Operator’s Manual).

For the Delete function, the TEST PANEL

is displayed, the results are wiped out (see
description of TEST PANEL, chapter 2.2.1.
of the STA Compact ® Operator’s Manual).

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.8. Customer Printout of Validated Files

6.8.1. Generalities

This menu gives the opportunity to print the Patient Files according to each laboratory specific
needs.

The Patient Files concerned by this customer printout are all the confirmed Files present in the
Working File.
(Note: a confirmed Patient File is a Patient File for which all tests are done and confirmed).

The location and the type of information related to the Patient Files (Patient ID, test name, results)
are fixed ; only the headings or the additional remarks are defined by each laboratory.
Only one file is printed by page.

☞ Caution! By means of this menu, the results are printed out without any alarm
messages. For that reason, an important part of the information which
may influence the results are missing. Boehringer Mannheim denies
all responsibilities as for the utilization of this menu.
For customer printout of Patient Files:
– the printout parameters must be defined, see Chapter 6.8.4. of the STA Compact ®
Operator’s Manual,
– the Patient Files to be printed must be selected, see Chapter 6.8.5. of the STA Compact ®
Operator’s Manual,
– the printout must then be run, see Chapter 6.8.6. of the STA Compact ® Operator’s
Manual.

6.8.2. Access to CUSTOMER PRINTOUT OF VALIDATED FILES Screen

Note: This access is only possible if STA Compact ® is in stand-by mode (no measurements
in progress).

START: TEST PANEL displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is

displayed:

Status Loading Files (...) - Halt

with cursor on Status.

Press the F key (Files). The Files menu is displayed:

Confirmation/Printout/Transmission
Delete Patient Files
Customer Printout

with the cursor on Confirmation/ Printout/

Transmission.

Move the cursor to Customer Printout T he C U S T O M E R P R I N T O U T O F

with the ↑ key, then confirm with the VALIDATED FILES screen is displayed
↵ key. (see description, Chapter 6.8.3. of the STA
Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.8.3. Description of the CUSTOMER PRINTOUT OF VALIDATED FILES Screen

Fig. 11 - CUSTOMER PRINTOUT

OF VALIDATED FILES Screen

❶ Available functions:

F6 Prints out the confirmed Patient File on which the cursor is positioned;
Esc Options, this key opens the following window:

Change File Selection

Print Unprinted Files
Print all Files
Printout Configuration

Quit

* Change File Selection: selects a group of Patient files (see chapter 6.8.5. of
the STA Compact ® Operator’s Manual);

* Print Unprinted Files: prints only the unprinted files from a selection of Patient
files (see chapter 6.8.6. of the STA Compact ® Operator’s Manual);

* Print all Files: prints all the selected files (see chapter 6.8.6. of the
STA Compact ® Operator’s Manual);

* Printout Configuration: defines the printout parameters (see description,

Chapter 6.8.4. of the STA Compact ® Operator’s Manual);

* Quit: returns to the TEST PANEL.

❷ Complementary information (name, first name ... see description Chapter 8.2.3.3. of the
STA Compact ® Operator’s Manual) for the file on which the cursor is positioned.

❸ Selected File List. The letter (P) shows that the file has already been printed by means of the
CUSTOMER PRINTOUT OF VALIDATED FILES screen.

❹ Warning Message.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.8.4. To Define the Customer Printout Parameters

6.8.4.1. Customer Printout Format

Fig. 12 - Customer Printout Format

MAIN TITLE No.1

MAIN TITLE No.2 ➊

Secondary Title No.1

Secondary Title No.2
Secondary Title No.3 ➊
Secondary Title No.4

General Data Name No.1 POP2 ➋

General Data Name No.2 GARRISSON Tim ➌
General Data Name No.3 Surg. ➍
General Data Name No.4 10 ➎
Date 16/02/1995 ➏

<————————- ➊ ————————->

Result +
Result Title # 1 ➊ Result Title # 2 ➊ Title # 3
➊
PTT 35.0 sec. 1.00 Ratio 35.0 Ref.T. 28.0 ... 40.0 sec.
Fibrinogen 259 mg/dl 21.7 sec. 200 ... 400 mg/dl
➐ ➑ ➒ ➓

INR normal values are: ➊

Note ➊

➊ Final Title No.1

Final Title No.2

Note: To determine the length of the Patient File, the Customer Printout menu uses the
Page Length parameter defined within the Files menu (PRINTOUT window,
CONFIRMATION/PRINTOUT screen) on condition that this parameter is at least
greater than 54 (see Chapter 6.5. of the STA Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

❶ Data defined by the laboratory (Titles, data, name, notes ...). For these data definitions, see
Chapters 6.8.4.3. and 6.8.4.4. of the STA Compact ® Operator’s Manual.

❷ Patient File Identification (16 characters maximum), Field No.1 as defined within the Global
Options menu, see Chapter 8.2.3.3. of the STA Compact ® Operator’s Manual.

❸ Content of fields No.2 and No.3 as defined within the Global Options menu, see chapter 8.2.3.3.
of the STA Compact ® Operator’s Manual, (16 characters and 12 characters maximum).
The field No.2 content is printed in upper case character. The first character of the field No.3
content is printed in upper case character, the remaining in lower case character.

❹ Content of field No.4 as defined within the Global Options menu, see Chapter 8.2.3.3. of the
STA Compact ® Operator’s Manual (6 characters maximum).

❺ Content of field No.5 as defined within the Global Options menu, see Chapter 8.2.3.3. of the
STA Compact ® Operator’s Manual (4 characters maximum).

❻ Printout Date. The used format is defined within the Global Options menu, see Chapter 8.2.3.4.
of the STA Compact ® Operator’s Manual.

❼ Test complete name as defined within the Test Setup menu (see Chapter 3.1.1.1. of the STA
Compact ® Operator’s Manual).
The result table can contain an entire file, i.e.: 12 tests.

❽ Result in primary unit.

❾ Result in first secondary unit.

❿ Result in second secondary unit.

Result in third secondary unit.

Note: Results for secondary units can be printed only if YES has been selected for the Printout
within the TEST SETUP screens, see Chapter 3.1.3.1. of the STA Compact ® Operator’s
Manual.

Note: The fields ➑, ➒, ➓ and are replaced by the message “Out of Range” if the result
has been confirmed even though its status was “Time > T max”, see Chapter 6.3.3. of
the STA Compact ® Operator’s Manual.

Usual values for each test as defined with the TEST SETUP screens, see Chapter 3.1.3.2. of
the STA Compact ® Operator’s Manual.

Standard note as defined within the FILE PROCESSING screens, see Chapters 6.3.6. to 6.3.8.
of the STA Compact ® Operator’s Manual.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.8.4.2. Access to PRINTOUT CONFIGURATION Screens

START: CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed, see Chapter

6.8.2. of the STA Compact ® Operator’s Manual.

ACTIONS RESULTS

Press the Esc key. The following sub-menu is displayed

Change File Selection

Print Unprinted Files
Print all Files
Printout Configuration

Quit

with cursor on Quit.

Move the cursor to Printout Configura- T h e fir s t s c r e e n o f PRINTOUT

tion with the ↑ key, then confirm with CONFIGURATION is displayed (see below
the key ↵. Chapter 6.8.4.3. of STA Compact ®
Operator’s Manual).

6.8.4.3. First PRINTOUT CONFIGURATION Screen (Customer Printout Menu)

Fig. 13 - PRINTOUT CONFIGURATION Screen,

page 1 of 2

Note: For the customer printout format, see Chapter 6.8.4.1. of the STA Compact ® Operator’s
Manual.
❶ Available functions:

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen;

PgDn Displays the second PRINTOUT CONFIGURATION screen;

↑↓ Moves the cursor to the following line (↓ key) or to the preceding line ( ↑ key);

F10 Saves the printout parameters.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

➋ Definition of 2 main titles:

2 lines of 48 characters.

If one of the two titles contains more than 35 characters, then the 2 main titles are printed in
enlarged, bold and condensed format, otherwise (<35), they are printed in enlarged and bold
format.

Note: The first main title is an obligatory acquisition field.

➌ Definition of 4 secondary titles:

4 lines of 60 normal characters. The non-defined titles are printed out as blank lines.

➍ Definition of 5 general data names:

5 lines of 25 characters printed in normal format. The general data names have to be defined
according to their respective contents, see description Chapter 6.8.4.1. of the STA Compact ®
Operator’s Manual.

Note: General data names No.1, No.2 and No.5 are obligatory acquisition fields.

6.8.4.4. Second PRINTOUT CONFIGURATION Screen (Customer Printout Menu)

Fig. 14 - PRINTOUT CONFIGURATION Screen,

page 2 of 2

Note: For the customer printout format, see Chapter 6.8.4.1. of the STA Compact ® Operator’s
Manual.

❶ Available functions:

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen;

PgUp Displays the first PRINTOUT CONFIGURATION screen;

↓↑ Moves the cursor to the following line (↓ key) or to the preceding line ( ↑ key);

F10 Saves the printout parameters.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

➋ Definition of the titles for the result table:

3 lines of 16 characters printed in condensed and bold format.

These titles have to be defined according to the respective content of each column, see Chapter
6.8.4.1. of the STA Compact ® Operator’s Manual.

Note: The 3 result titles are obligatory acquisition fields.

➌ Constant remark:

2 lines of 60 characters printed on one line in condensed format.

➍ Definition of the optional note name:

1 line of 16 characters.
See definition, point of Chapter 6.8.4.1. of the STA Compact ® Operator’s Manual.

➎ Definition of the 2 final titles:

2 lines of 40 characters printed in bold, enlarged and condensed format.

6.8.4.5. Modification of the Customer Printout Definition Parameters

START: PRINTOUT CONFIGURATION screen displayed, see access Chapter 6.8.4.2. the
STA Compact ® Operator’s Manual.

ACTIONS RESULTS

M o ve the cursor to the requested The cursor is positioned on the requested

parameter with the ↓ key. parameter.

Enter t h e n e w in f or m a t io n o n t he The new information are displayed.

alphanumeric keyboard, then confirm with
the ↵ key. The cursor moves to the next data.

When all information are entered, press Customer printout definition parameters
the F10 key. are saved.

Back to the CUSTOMER PRINTOUT OF

VALIDATED FILES screen.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.8.5. To Select Files for the Customer Printout

6.8.5.1. Access to the FILE SELECTION Window (Customer Printout)

START: CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed, see chapter

6.8.2. of the STA Compact ® Operator’s Manual.

ACTIONS RESULTS

Press the Esc key. The following sub-menu is displayed

Change File Selection

Print Unprinted Files
Print all Files
Printout Configuration

Quit

with cursor on Quit.

Press the C key (Change File T h e FILE SELECTION w in d ow is

Selection). displayed (see description, Chapter
6.8.5.2. of the STA Compact ® Operator’s
Or move the cursor to Change File Manual).
Selection with the ↓ key, then confirm
with the ↵ key.

6.8.5.2. Description of the FILE SELECTION Window (Customer Printout)

Fig. 15 - FILE SELECTION Window (Customer Printout)

❶ Identification of the first file of the file selection;

❷ Identification of the last file of the file selection;

❸ Available functions:

F1 displays “Start” corresponding to the first file of the confirmed files listing in chronological
order in the Working File.

F2 displays “End of File” corresponding to the last file of the confirmed files listing in
chronological order in the Working File.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

F3 Selects the files with the cursor in the available files.

F10 Executes the selection and displays it.

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen.

↑ ↓ Moves the cursor to the different parameters.

❹ Filtering prefix identification.

6.8.5.3. Change the Selection (Customer Printout)

START: FILE SELECTION window displayed from CUSTOMER PRINTOUT OF VALIDATED

FILES screen, (see description on Chapter 6.8.5.1. of the STA Compact ® Operator’s
Manual).

ACTIONS RESULTS

Type the identification of the first file of the The identification of the first file of the list is
desired selection then confirm with the ↵ displayed in area ➊ or “Start ” is displayed
key. in area ➊ and the cursor is positioned in
area ➋, see description of the FILE
Or press the F1 key to display “Start” SELECTION window, Chapter 6.8.5.2. of
(corresponding to the first confirmed file the STA Compact ® Operator’s Manual.
(the oldest) of the Working File).

Or press the F3 key to select the files with

the cursor. In this case, use the moving
cursor keys to move it to the required file,
then confirm with the ↵ key.

Caution: It is impossible to use F1/F2

keys with the F3 key.

Type the identification of the last file of the The identification of the last file of the list is
desired selection then confirm with the ↵ displayed in area ➋ or “End of File” is
key. displayed in area ➋ and the cursor is
positioned in area ❹ , see description of the
Or press the F2 key to display “End of File” FILE SELECTION window, Chapter 6.8.5.2. of
(corresponding to the last confirmed file the STA Compact ® Operator’s Manual.
(the latest) of the Working File).

To select the last file with the cursor, use

the moving cursor keys to move it to the
required file, then confirm with the ↵ key.

Caution: It is impossible to use F1/F2

keys with the F3 key.

To filter: type the prefix identification, then Filtering prefix identification displayed in
confirm with the ↵ key. the area ❹ (if defined), see description of
the FILE SELECTION window, Chapter
Or type the first number(s) or letter(s) of the 6.8.5.2. of the STA Compact ® Operator’s
patient files identification, then confirm Manual.
with the ↵ key.

Or leave the area empty (no prefix

definition) and confirm with the ↵ key.

When all the parameters of the desired The new selection is displayed on the
selection are set, press the F10 key. CUSTOMER PRINTOUT OF VALIDATED
FILES screen, see description, chapter
6.8.3. of the STA Compact® Operator’s
Manual.

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STA COMPACT ® OPERATOR'S MANUAL Patient File Management

6.8.6. Printout of a File Selection (Customer Printout)

START: CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed, see access

chapter 6.8.2. of the STA Compact ® Operator’s Manual.

ACTIONS RESULTS

Press the Esc key. The following sub-menu is displayed:

Change File Selection

Print Unprinted Files
Print all Files
Printout Configuration

Quit

with cursor on Quit.

Depending on the required Patient files: A window is displayed in the upper left
corner of the screen. This window indicates
* All the files not yet printed, the identification of the file being processed
move the cursor to Print Unprinted as well as the number of files remaining to
Files with the ↓ key, then confirm with print.
the ↵ key.
At the same time, the file printout starts.
* All the selected files:
move the cursor to Print all Files with
the ↑ key, then confirm with the ↵ key.

To stop the current printout, press the The files already processed are being
Esc key. printed.

Then, the printout stops.

When all files are printed. Automatic return to the list of selected files.

The letter P is printed in front of the

identification of each file actually printed.

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Patient File Management STA COMPACT ® OPERATOR'S MANUAL

6.9. Download of Working Lists

Purpose: To request once again to the host computer the working list for all patient tubes
already loaded which have not received it during the loading step. Indeed, if the
Patient File identification is not known by the host computer while loading the tube,
the STA Compact ® receives no answer. Without this function, the only way to
perform once again the working list request is to unload the tubes and load them
again one by one.

START: TEST PANEL displayed.

ACTIONS RESULTS

Press the F11 key. The following window is displayed:

_______________________________

Downloading
File: xxxx

_______________________________

ESC = Abort

xxxx = identification of the Patient File being

downloaded.

The Patient File working lists are

received.

6 - 40 V 1.0 - November 96
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 7

7. QUALITY CONTROL 1

7.1. Generalities 1

7.2. Access to Quality Control Results 2

7.3. Description of the Quality Control Screens 3

7.3.1. Description of the QUALITY CONTROL Screen (Test List) 3
7.3.2. Description of a Quality Control Result Screen (Graphic Form) 4
7.3.3. Description of a Quality Control Result Screen (Tabular Form) 6

7.4. Procedures to Run and to Confirm Quality Controls 8

7.4.1. Main Principles 8
7.4.2. Loading of Quality Controls 9
7.4.3. Changing the Range of Acceptable Results for Quality Controls 9
7.4.4. Running One Level of Quality Control 10
7.4.5. Simplified Running for Quality Controls 11

7.5. Procedures to Observe for out of Range Quality Controls 13

7.5.1. Alarm Code and Alarm Message Displayed for out of Range Quality Controls 13
7.5.2. Description of the CONTROL OUT OF RANGE Window 13
7.5.3. Accepting out of Range Quality Controls 14
7.5.4. Rerunning out of Range Quality Controls 15

7.6. Other Available Operations on Quality Controls 16

7.6.1. Cancelling a Running Control 16
7.6.2. Deleting Today’s Controls 16
7.6.3. Deleting All Results of Quality Controls 17
7.6.4. Printing Quality Control Results 18
7.6.4.1. Printing Quality Control Results as Graphic Form 18
7.6.4.2. Printing Quality Control Results as Tabular Form 19
7.6.5. Transmitting Today’s Quality Control Results 20

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

7. QUALITY CONTROL
7.1. Generalities

For each test, at least one quality control has to be run daily if at least one patient result is
requested for this test.
Up to three quality controls can be defined for each test within the TEST SETUP screens (see
chapter 3.1.3.4. of the STA Compact ® Operator’s Manual).
Quality controls are loaded in the product drawer and are automatically run by STA Compact ®
(see details, chapter 7.4. of the STA Compact ® Operator’s Manual).

In the Quality Control sub-menu, the quality control results are treated on 3 zones:
– CONTROLS FOR TODAY zone;
– CUM DAILY zone;
– CUM MONTHLY zone.
(see description of these zones, chapters 7.3.2. and 7.3.3.of the STA Compact ® Operator’s
Manual).

In these zones, up to 2 lot numbers can be stored.

Caution! When controls from a new lot are loaded, values of the oldest lot are automatically
deleted, the preceding lot changes into the old lot and the new lot into the current
lot.

The treatment of the quality controls is based on the Levy-Jennings statistical model:

i =n

Mean: m= ∑x i xi = result in primary unit

i =1


√
i =n

∑( x − m )
i
2

Standard deviation σ= i =1
n−1

100 σ
Coefficient of variation : CV =
m

n varies depending on the treatment zone:

Zone n

CONTROLS FOR TODAY 1 to 24

CUM DAILY 1 to 31

CUM MONTHLY 1 to 31

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

7.2. Access to Quality Control Results

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading - (...) - Halt

with cursor positioned on Status.

Press the C key (Calib./Control). The sub-menu is displayed:

Calibration
Quality Control

with the cursor on Calibration.

Press the ↓ key to Quality Control, then T h e QUALITY CONTROL screen is

confirm with the ↵ key. displayed (see description, chapter 7.3.1.
of the STA Compact ® Operator’s Manual).

The cursor is positioned on the first test of

the list.

Press the ↓ or  keys to move the cursor Results of quality control for the first control
to the selected test, then confirm with the displayed in graphic form (see description,
↵ key. chapter 7.3.2. of the STA Compact ®
Operator’s Manual).

Press the F3 key. Results of quality control for the next control
displayed in graphic form (see description,
Note: If only one quality control level has chapter 7.3.2. of the STA Compact ®
been defined; with F3, the same Operator’s Manual).
level is displayed. For 2 or 3 levels,
with F3, the different levels are
looped.

Press the F2 key. Return to the results of the preceding

control in graphic form (see description
chapter 7.3.2. of the STA Compact ®
Operator’s Manual).

Press the F1 key. Results of quality control for the control in

progress displayed in tabular form (see
description, chapter 7.3.3. of the STA
Compact ® Operator’s Manual).

From the screen of quality control results Return to QUALITY CONTROL screen (test
in graphic form, press the Esc key, then list).
confirm with the ↵ key.

Press the Esc key. Return to TEST PANEL screen.

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

7.3. Description of the Quality Control Screens

7.3.1. Description of the QUALITY CONTROL Screen (Test List)

Fig. 1 - QUALITY CONTROL Screen (Test List)

➊ Available keys:

↵ Views the quality control results of the selected test.

F1 Select Controls to Run: requests running of all quality control levels for the test on
which the cursor is positioned.

F10 Run Selected Controls: runs quality controls requested by F1 option

(see procedure of simplified run, chapter 7.4.5. of the STA Compact ® Operator’s
Manual).

Esc Returns to TEST PANEL screen.

➋ Name of this screen

➌ List of test abbreviations. A colored square displayed at the left of the abbreviation indicates the
quality control current status (see point ➎ below).

➍ Complete name of the test on which the cursor is positioned

➎ Color codes identifies the status of each quality control:

– White : validated;
– Blue : to be validated;
– Yellow : in progress;
– Red : not done.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

7.3.2. Description of a Quality Control Result Screen (Graphic Form)

Fig. 2 - Quality Control Result Screen

(Graphic Form)

Available keys:

F1 Views the results in tabular form.

F2/F3 Accesses the other levels ; the results are always displayed in graphic form.

Esc Options ; this key opens the following window:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

* Print : prints of graphic screen;

* Run : runs quality control for the displayed level;
* Cancel : cancels quality control (status: “in progress”) for the
displayed level;
* Change Range : changes the range of acceptable results;
* Delete All Results : purges all the displayed values;
* Return to Result List : returns to the QUALITY CONTROL screen (test list).

Note: When an option is not available, its name is displayed in grey instead of blue.

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

➋ Level indication: 1, 2 or 3

➌ Complete name of the test

➍ Primary unit to express results

➎ Control identification number

❻ Complete name of the control

➐ Current lot number of the control

➑ CUM DAILY: zone to display the last 31 means of daily controls.

The points do not necessarily correspond to consecutive days, they may come from several
months. The day corresponding to each mean is displayed at the foot of the CUM DAILY
zone.

Adding a new point is made from the right side of the existing points; shifting those points to
the left when there are more than 31 values. In this case, visualization of the first point is lost.

The means of the daily controls are displayed according to the following color codes:

+++ (green) : daily control means obtained during preceding months which are within the
range of acceptable results.

+++ (red) : daily control means obtained during preceding months which are outside
of the range of acceptable results.

xxx (yellow) : daily control means for the current month wich are within the range of
acceptable results.

xxx (red) : daily control means for the current month which are outside of the range of
acceptable results.

∆ (red) : result out of scale.

Note: When the range of acceptable results is changed, the colors of the various points are
reviewed according to the new range of acceptable results (see description, chapter
7.4.3. of the STA Compact ® Operator’s Manual).

➒ CONTROLS FOR TODAY zone:

Zone to display the quality control results for a 24-hour period. From the day change, as soon
as a quality control is confirmed (manually or automatically), this zone is automatically emptied
and the point corresponding to the mean of the last 24-hour period is displayed in the CUM
DAILY zone.
In the CONTROLS FOR TODAY zone, points are added to the right of the existing ones.

Points of this zone are displayed according to those color codes:

– o (blue) : result within the range of acceptable results for the quality control;
– o (red) : result outside of the range of acceptable results for the quality control;
– ∆ (red) : result out of scale.

➓ Green vertical bar indicating a lot change (up to 2 lots are treated)

Range of acceptable results for the quality control. It is represented by white stippled lines which
are displayed in the 3 zones: CONTROLS FOR TODAY/CUM DAILY/CUM MONTHLY.

Mean of the range of acceptable results for the quality control, it is represented by a white line
which is displayed in the 3 zones: CONTROLS FOR TODAY/CUM DAILY/CUM MONTHLY.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

Mean ± 2 σ (σ = standard deviation) for quality control results of the CUM DAILY zone, it is
represented by yellow stippled lines.

Mean of quality control results of the CUM DAILY zone, it is represented by a yellow line.

Glossary explaining the meanings of the color codes displayed on the screen.

CUM MONTHLY zone:

Zone to display the monthly means for the quality control results. For each calendar month, the
mean ± 2 σ is shown: mean by a yellow line, mean + 2 σ and mean - 2 σ by stippled lines. Out
of scale values are displayed with a ∆ red. The month number is displayed at the foot of the CUM
MONTHLY zone.

7.3.3. Description of a Quality Control Result Screen (Tabular Form)

Fig. 3 - Quality Control Result Screen

(Tabular Form)

➊ Available keys:

Esc Back to Graph: returns to graphic form for quality control results of the selected level.

F4 Suppress Current Controls: supresses one or several results from the CURRENT
CONTROLSzone.

F6 Print: prints results as tabular form.

F11 Transmit Current Controls: Transmits all today’s quality control results to the Host
computer.

➋ Level indication: 1, 2 or 3

➌ Complete name of the test

➍ Primary unit to express results

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

➎ Control identification number

❻ Complete name of the control

➐ Current lot number of the control

CURRENT CONTROLS zone:

➑ Zone to display the results of today’s quality controls

The following indications appear:

– the result in primary units (Res.);
– the hour (Time) at which the quality control has been run.

They are displayed:

– in dark blue for values obtained with the old lot;
– in light blue for values obtained with the current lot;
– in red when the values are out of the range of acceptable results.
➒ Day when the controls have been run
➓ Range of acceptable results for the current lot of the quality control in the primary unit
Mean, Standard Deviation and coefficient of variation for the results of the today quality
controls

DAILY MEANS zone:

Zone to display the last 31 daily means

The following indications appear:

– The day (D);
– The daily mean (Mean).

They are displayed:

– in dark blue for the old lot;
– in light blue for the current lot;
– in red for daily means which are outside of the range of acceptable results.
Mean, Standard Deviation and coefficient of variation for the daily means from the old
lot (displayed in dark blue).
Mean, Standard Deviation and coefficient of variation for the daily means from the
current lot (displayed in light blue).

MONTHLY MEANS zone:

Zone to display the last 12 monthly means.

The following indications appear:

– The month (M),
– The monthly mean (Mean),
– The monthly Standard Deviation (σ),
– The monthly coefficient of variation (cv).
They are displayed:
– in dark blue for the old lot;
– in light blue for the current lot.
– in red when the monthly means are outside of the range of acceptable results.

Note: For the month corresponding to the lot change, the displayed mean corresponds to that
with the more representative points.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

7.4. Procedures to Run and to Confirm Quality Controls

7.4.1. Main Principles

The quality controls for a related test are automatically run by STA Compact ® as soon as STA
Compact ® has to perform an analysis of this test and that the time elapsed since the last control
run is greater than the period defined within the TEST SETUP screens (see chapter 3.1.3.4. of the
STA Compact ® Operator’s Manual). This period cannot exceed 24 hours. Quality controls can
also be run on operator’s request from these 2 screens:
– QUALITY CONTROL screen (test list). In this case, all quality control levels of the selected test
are run (simplified run, see description chapter 7.4.5. of the STA Compact ® Operator’s
Manual).
– screen for quality control results for a selected level. In this case, only the selected level is
run.

Note: Running controls on request is possible only if the sample pipetting has not been blocked
either from the TEST STATUS screen (see description, chapter 8.1.3. of the STA Compact ®
Operator’s Manual) or by the Stop Sample pipetting function of the Status sub-menu
(see description, chapter 8.1.5.1. of the STA Compact ® Operator’s Manual).
To block tests by means of the FILE MODIFICATION screen blocks the quality control
automatic (periodic) running function but not a running decided by the operator (see
description, chapter 6.7.3. of the STA Compact ® Operator’s Manual).

Quality controls are run in single or in duplicate depending on the determination type chosen
for the sample (see description, chapter 3.1.1.7. of the STA Compact ® Operator’s Manual).

As soon as quality control results are obtained, they are compared to the range of acceptable
results, if they are outside of the range, STA Compact ® automatically reruns the controls
according to the principle below:

Automatic Rerun
First run Result(s)
by STA Compact ®

Control run in single outside of of the defined Control rerun in duplicate

range

Control run in duplicate 1 of the 2 results outside of Control rerun in single

of the defined range

If the quality control is confirmed as outside of of the range of acceptable results, all the patient
results for the related test will be given with an alarm code: “Quality Control: out of range or
not done”; they will be displayed in light red on the TEST PANEL screen.

If the operator decides to accept quality control results declared as out of range, all patient
results for the related test will be given with an alarm code: “Quality Control: overridden”.

If quality controls have been run or rerun, when returning to the TEST PANEL screen, STA Compact ®
performs a consistency check and displays the TEST STATUS screen (see description, chapter
8.1.3. of the STA Compact ® Operator’s Manual).

If upon running quality controls (automatically or on request), those are not present in the drawer
(not present or present but with volume or stability not usable) and if the time elapsed since the
last quality control run is less than 24 hours, then STA Compact ® does not perform the control,
proceeds with the assays for the related test and all patient results for the related test are given
with an alarm code: “Quality Control: out of range or not done”. In the same case, with an
elapsed time greater than 24 hours, the sample pipetting for the related test is blocked.

If the control lot number has changed or if the quality control results have been reset, the sample
pipetting for the related test will start again only when the products necessary to perform the
first controls will have been loaded. In the same way, the sample pipetting for the related test
will be blocked as long as the range values have not been defined.

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

Reminder: When the same controls are used (same Identification Numbers) as calibration
controls and as quality controls, the results of the calibration controls are
added into the results for quality controls and the time at which the calibration
controls have been run resets the clock for the quality controls.

If the On-Line Transmission option is actuated (see chapter 8.1.5.2. of the STA Compact ®
Operator’s Manual), then all quality control results will be sent with their error codes as soon as
the measurements are obtained.

☞ Caution! No alarm codes will be sent for quality controls.

For description of the error and alarm codes, see chapter 6.3.2. of the STA Compact ® Operator’s
Manual. Each quality control result will be sent with its running date and its running time.
If the On-Line Transmission is not actuated, all today’s confirmed quality control results can
be sent from the quality control result table, see chapter 7.6.5. of the STA Compact ® Operator’s
Manual.

7.4.2. Loading of Quality Controls

The quality controls are loaded in the product drawer (see description, chapter 4.6. of the STA
Compact ® Operator’s Manual). At each lot number change, the values for the range of acceptable
results for the Diagnostica Stago controls are read out by means of the barcode sheets inserted in
each control box. For the other controls, these values have to be manually entered.

Reminder: For Diagnostica Stago controls, the values for the range of acceptable results
are properly dispatched into the related tests, on condition that for those, the
primary unit chosen is identical to that defined on the package inserts of each
control box (except Fibrinogen, for g/l primary unit, values are properly
dispatched even if on the package insert, they are given in mg/dl).

7.4.3. Changing the Range of Acceptable Results for Quality Controls

☞ Caution! This procedure is possible only if:

– the selected control is not running, its status is “to be validated” or “not done”
because of missing products;
– the operator knows the access code to critical functions, (see chapter 1.8.4.
of the STA Compact ® Operator’s Manual).

Notes: • For controls which are not from Diagnostica Stago, the range of acceptable results
has to be absolutely defined at each lot change so that controls can be run.

• For controls from Diagnostica Stago, the range of acceptable results can only be
reduced, it cannot be in any case increased.

START: Screen of quality control results (graphic form) displayed for the selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS
Press the Esc key. The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

with the cursor positioned on Return to

Result List.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS
Move the cursor to Change Range with The following window is displayed:
the ↑key, then confirm with the ↵ key.
Range Modification

New Values ➊ xxx - xxx %➌

(Original Values ➋ xxx - xxx)

F10 Save Esc Abort

with cursor positioned on the Entry zone

for new values.

➊ Entry zone for the new range values in

primary unit.
➋ For controls from Diagnostica Stago,
range values as read out from the
bar codes.
➌ Primary unit is recalled.
Type the new range values, confirm with T he Range Modification w in d o w
the ↵ key then save the new values with disappears.
the F10 key.
The following window is displayed:

Please enter
your access code:

↵ Validate Esc: Quit

Type your access code, then confirm with The screen for quality control results is
the ↵ key. displayed with the new range of acceptable
results.
In the 2 zones: CONTROLS FOR TODAY
and CUM DAILY, all points outside of the
new range are displayed in red.

7.4.4. Running One Level of Quality Control

Note: Running is impossible:

– if control is already running or if its status is “to be validated”;

– if the calibration for the selected test is not validated;
– if products necessary to perform the control are not present;
– if the values for the range of acceptable results have not been defined (see chapter
7.4.3. of the STA Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

START: Screen of quality control results (graphic form) displayed for the selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window appears:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

with the cursor positioned on Return to

Result List.

Move the cursor to Run with the ↑ key, then The following window is displayed:
confirm with the ↵ key.
Please enter
your access code:

↵ Validate Esc: Quit

Type your access code, then confirm with STA Compact ® runs the quality control
the ↵ key. level so long as the consistency ckeck does
not lead to a blocking of the sample
pipetting.

Press the Esc key then confirm with the Return to QUALITY CONTROL screen (test
↵ key. list).

7.4.5. Simplified Running for Quality Controls

Note: Running is impossible:

– for tests whose one of the controls is already running or having its status “to be
validated”;
– for tests whose calibrations are not validated;
– If products necessary to run the quality controls are not present, (see chapter 7.4.1.
of the STA Compact ® Operator’s Manual);
– for tests whose range of acceptable results of quality controls have not been defined
(see chapter 7.4.3. of the STA Compact ® Operator’s Manual).
START: CONTROL QUALITY screen (test list) displayed (see access, chapter 7.2. of the
STA Compact ® Operator’s Manual).

ACTIONS RESULTS

For each test whose quality controls are If running is possible (all products
requested, move the cursor on its necessary are loaded and the control
abbreviation, then press the F1 key. ranges have been defined), the S letter is
d i s p l a y ed a t t h e le f t o f ea c h t e s t
Note: To cancel a running request, press abbreviation for which controls have been
the F1 key again. requested.

If running is impossible, STA Compact ®

beeps and the S letter is not displayed.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

When all requested controls are selected, The following window is displayed:
press the F10 key.
Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with The S letters at the left of the abbreviations
the ↵ key. disappear.

Controls are run by STA Compact ® so long

as the consistency ckeck does not lead to
a blocking of the sample pipetting.

The colored squares at the left of the

abbreviations for the selected tests are
displayed in yellow so long as the
consistency ckeck does not lead to a
blocking of the sample pipetting.

Press the Esc key. The TEST PANEL screen is displayed (see
desciption, chapter 8.1.3. of the STA
Compact ® Operator’s Manual).

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

7.5. Procedures to Observe for out of Range Quality Controls

7.5.1. Alarm Code and Alarm Message Displayed for out of Range Quality Controls

When a quality control result is outside of of the range of acceptable results (out of range), the
operator is informed by the following message:

MEASURING MANAGEMENT

Error 05.06.09
.
QUALITY CONTROL
.
Control out of limits
for the test xxx

Esc = continue

xxx = Test Abbreviation

For the related test, all patient results are given with an alarm code: “Quality Control: out of
range or not done” and on the TEST PANEL screen, all results are displayed in light red.

7.5.2. Description of the CONTROL OUT OF RANGE Window

Fig. 4 - CONTROL OUT OF RANGE Window

➊ Test abbreviation

➋ Quality control identification number

➌ Results obtained for the quality control (in the primary unit)

➍ Recall of the range of acceptable results for the quality control (in primary unit)

➎ Recall of the mean for the CUM DAILY zone

❻ Recall of the mean for the CUM MONTHLY zone

V 1.0 - January 96 7 - 13
Quality Control STA COMPACT ® OPERATOR'S MANUAL

➐ Available functions:

Accept: accepts an out of range quality control (see description, chapter 7.5.3. of the STA
Compact ® Operator’s Manual).

Rerun: reruns the quality control (see description, chapter 7.5.4. of the STA
Compact ® Operator’s Manual).

Postpone Decision: returns to QUALITY CONTROL screen (test list).

7.5.3. Accepting out of Range Quality Controls

☞ Caution! This procedure is only possible if the operator knows the access code which allows
to accept out of range controls (see chapter 1.8.4. of the STA Compact ® Operator’s
Manual).

Reminders: • If the operator accepts quality control results although out of range, all patient
results for the related test will be given with this alarm code: “Quality Control:
overridden”.

• In the CONTROL OUT OF RANGE window, out of range results are displayed
in red and the range of acceptable results is displayed (see description, chapter
7.5.2. of the STA Compact ® Operator’s Manual).

START: Screen of quality control results displayed with the CONTROL OUT OF RANGE window,
cursor positioned on Postpone Decision.

ACTIONS RESULTS

Press the A key (Accept). The CONTROL OUT OF RANGE window

disappears.

Or move the cursor to Accept with the ↑ The following window is displayed:
key then confirm with the ↵ key.
Please enter
your access code:

↵ Validate Esc Quit

Type your access code, then confirm with Depending on the value of the out of range
the ↵ key. result, a red o or a red ∆ (out of scale) is
displayed in the CONTROLS FOR TODAY
zone.

Press the Esc key, then the ↵ key. Return to QUALITY CONTROL screen (test
list).

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7.5.4. Rerunning out of Range Quality Controls

Reminders: • When the STA Compact ® declares a quality control as out of range, the control
has already been run 3 times.
Indeed, if a control result is outside of the range of acceptable results, for a
single determination, control is rerun in duplicate and for a duplicate
determination, it is rerun in single (see description, chapter 7.4.1. of the STA
Compact ® Operator’s Manual).

START: Screen of quality control results displayed with the CONTROL OUT OF RANGE window,
cursor positioned on Postpone Decision.

ACTIONS RESULTS

Press the R key (Rerun). The following window is displayed:

Or move the cursor to Rerun with the ↑ Please enter

key, then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

Type your access code, then confirm with STA Compact ® reruns the quality control
the ↵ key. so long as the consistency ckeck does not
lead to a blocking of the sample pipetting.

Return to the quality control results of the

selected control level.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

7.6. Other Available Operations on Quality Controls

7.6.1. Cancelling a Running Control

Note: This function is not available if the control status is “confirmed”, “to be validated” or “not
done”. It is only possible for running controls (yellow square at the left of the test
abbreviation).

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window appears:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

with the cursor positioned on Return to

Result List.

Move the cursor to Cancel with the ↑ key, The quality control running for the selected
then confirm with the ↵ key. level is cancelled.

Press the Esc key. Return to QUALITY CONTROL screen (test

list).

The colored square at the left of the

abbreviation for the selected test is
displayed in red (not done).

Press the Esc key. Return to TEST PANEL.

7.6.2. Deleting Today’s Controls

☞ Caution! This procedure is possible only if the operator knows the access code to critical
functions, (see chapter 1.8.4. of the STA Compact ® Operator’s Manual). It concerns
only quality control results of the CONTROLS FOR TODAY zone (see description of
this zone, chapter 7.3.2. (point ➒) of the STA Compact ® Operator’s Manual).

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the F1 key. The quality control results of the selected

level are displayed as tabular form.

Press the F4 key. The following window is displayed:

Please enter
your access code:

↵ Validate Esc Quit

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STA COMPACT ® OPERATOR'S MANUAL Quality Control

ACTIONS RESULTS

Type your access code, then confirm with The following window is displayed:
the ↵ key.
Current DEL Suppress
Controls INS Restore
Suppression F10 Save
Esc Abandon

The cursor is positioned on the first result

of the CURRENT CONTROLS zone.

For each result to be deleted, move the Each result which has to be deleted is
cursor to it with the ↓ key, then press the displayed in grey.
Delete key.

Press the F10 key. T h e Current Controls Suppression

window disappears.
No te! As long as the F10 key has not
been selected, results can be In the CURRENT CONTROLS zone, the
restored by the Insert key. selected results disappear.

Mean, σ and cv are updated.

Press the Esc key. Return to the quality control results as

graphic form.

7.6.3. Deleting All Results of Quality Controls

☞ Caution! For this operation, the operator must know the access code to critical functions, (see
chapter 1.8.4. of the STA Compact ® Operator’s Manual). This operation deletes all
quality control results for the selected level.

Note: This function is not available if the control status is “in progress” or “to be validated”.

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

with the cursor positioned on Return to

Result List.

Press the D key (Delete All Results). The following window is displayed:

Or move the cursor to Delete All Results Please enter

with the ↑ key, then confirm with the ↵ key. your access code:

↵ Validate Esc Quit

V 1.0 - January 96 7 - 17
Quality Control STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Type your access code then confirm with The following window is displayed:
the ↵ key.
DELETE ALL CONTROL RESULTS

Accept (YES/NO) xxxx ?

Type YES then confirm with the ↵ key. All quality control results of the selected
level are deleted.

Press the Esc key, then confirm with the Return to QUALITY CONTROL screen (test
↵ key. list).

7.6.4. Printing Quality Control Results

7.6.4.1. Printing Quality Control Results as Graphic Form

Note: This operation is possible only if the STA Compact ® is in stand-by mode (no
measurement in progress) and if all printouts previously generated have been
performed.

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the Esc key. The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

with the cursor positioned on Return to

Result List.

Press the P key (Print). The following window is displayed:

Or move the cursor to Print with the ↓ key, PRINTOUT

then confirm with the ↵ key.
EXECUTE

Printer Test
Form Feed

Quit

with cursor positioned on EXECUTE.

Press the ↵ key (EXECUTE). The “PRINTING ... ” indication is displayed at

the foot of the screen.

The Quality control results are printed as

graphic form for the selected level.

7 - 18 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Quality Control

ACTIONS RESULTS

When the “PRINTING ...” indication The PRINTOUT window disappears.

disappears, press the Esc key.
Return to the screen of quality control
results for the selected level (graphic form).

7.6.4.2. Printing Quality Control Results as Tabular Form

Note: This operation is possible only if the STA Compact ® is in stand-by mode (no
measurement in progress) and if all printouts previously generated have been
performed.

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the F1 key. The quality control results of the selected

level are displayed as tabular form.

Press the F6 key. The following window is displayed:

PRINTOUT

EXECUTE

Printer Test
Form Feed

Quit

with cursor positioned on EXECUTE.

Press the ↵ key (EXECUTE). The “PRINTING ... ” indication is displayed

at the foot of the screen.

The quality control results are printed as

tabular form for the selected level.

When the “ PRINTING ...”indication disappears, The PRINTOUT window disappears.

press the Esc key.
Return to the table of quality control results
for the selected level.

Press the Esc key. Return to the screen of quality control

results as graphic form.

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Quality Control STA COMPACT ® OPERATOR'S MANUAL

7.6.5. Transmitting Today’s Quality Control Results

START: Screen of quality control results displayed (graphic form) for a selected level (see
access, chapter 7.2. of the STA Compact ® Operator’s Manual).

ACTIONS RESULTS

Press the F1 key. The quality control results of the selected

level are displayed as tabular form.

Press the F11 key. The two following windows are displayed:

TRANSMITTING

then,

TRANSMISSION
COMPLETED

________________________

ESC = Clear this message

All today’s quality control results for the

selected level are transmitted to the host
computer with their respective running date
and time.

Press the ESC key. Return to the table of quality control results
for the selected level.

Press the ESC key. Return to the screen of quality control

results as graphic form.

7 - 20 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 8

8. MISCELLANEOUS SCREENS 1

8.1. STATUS Screens 1

8.1.1. Access to the STATUS Screens 1
8.1.2. SYSTEM STATUSScreen 2
8.1.2.1. Description of SYSTEM STATUS Screen 2
8.1.2.2. Modifying the Date 3
8.1.2.3. Modifying the Time 4
8.1.2.4. Modifying the Level Detection Management 5
8.1.3. Description of TEST STATUS Screen 6
8.1.4. Description of PRODUCT STATUS Screen 9
8.1.5. Options 11
8.1.5.1. Stop Sample Pipetting 11
8.1.5.2. On-Line Transmission (YES/NO) 11
8.1.5.3. On-Line Printout (YES/NO) 11

8.2. GLOBAL OPTIONS Screens 12

8.2.1. Access to the GLOBAL OPTIONS Screens 12
8.2.2. First GLOBAL OPTIONS Screen 13
8.2.2.1. Description of the First GLOBAL OPTIONS Screen 13
8.2.2.2. Printout 13
8.2.2.3. Access Codes 14
8.2.2.4. Bar Code Reading 14
8.2.2.5. Miscellaneous 14
8.2.2.6. Arbitrary Units 14
8.2.3. Second GLOBAL OPTIONS Screen 15
8.2.3.1. Description of the Second GLOBAL OPTIONS Screen 15
8.2.3.2. Communications 15
8.2.3.3. File Acquisition 16
8.2.3.4. Miscellaneous 17
8.2.4. Modification of a Global Option Parameter 17
8.2.4.1. Generalities 17
8.2.4.2. Modification Procedure for a Free Entry Field 18
8.2.4.3. Modification Procedure for a Multiple-Option Field: Passing Method 18
8.2.4.4. Modification of the Time Display Format 18
8.2.4.5. Modification of the Date Display Format 21
8.2.5. Saving Parameters from GLOBAL OPTIONS Screens 25

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8. MISCELLANEOUS SCREENS
8.1. STATUS Screens

The various STATUS screens display on one screen all the information concerning one of the
following :

– the system;
– the tests;
– the products: reagents, diluents, desorb solutions, controls and calibrators.

8.1.1. Access to the STATUS Screens

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading (...) - Halt

with the cursor on Status.

Press the ↵ key (Status). The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting YES
On-Line Transmission YES
On-Line Printout YES

with the cursor on System.

Then press one of the following keys for

the screen required:

↵ (System) The SYSTEM STATUS screen is displayed.

T (Tests) The TEST STATUS screen is displayed.

P (Products) The PRODUCT STATUS screen is displayed.

Note: To exit from the STATUS screens, press the Esc key and the TEST PANEL screen will be
displayed again.

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Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

8.1.2. SYSTEM STATUS Screen

8.1.2.1. Description of SYSTEM STATUS Screen

Fig. 1 - SYSTEM STATUS Screen

➊ Available function list:

Esc Options, this key opens the following window:

Change Date
Change Time
Level Detection Management
Quit

Change Date: updates the date.

Change Time: updates the time.
Level Detection Management: changes the option from managed to not
managed, see below the description of these two options in point 5.
Quit: returns to the TEST PANEL screen.

➋ Current date and time

➌ Title of the screen

➍ Measured Temperatures for the needle No.3, measurement block and product drawer:

– For needle No.3 and measurement block, when the temperature is out of range (36.5°C
to 37.5°C), the STA Compact ® stops the measurements and the temperature is
displayed in red.
– For product drawer, when the temperature is out of range (15°C to 19°C), the
temperature is displayed in red and each result is printed with a warning message:
“Product drawer: Temperature out of limit”

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

➎ Level detection options for each needle: No.1 (samples), No.2 and No.3.

– not managed (displayed in red):

* The level detection works but the software does not warn the operator that the liquids
are not detected;
* The level detection does not work. The STA Compact ® works now in grated mode
without level detection (the probe goes to the bottom of the tube or the vial).

In both cases, each result is printed with a warning message to the operator that the level
detection is not managed.

– managed (displayed in black):

* The software warns the operator with error messages for all level detection problems.

The operator can change the options of the level detection from managed to not managed
(and vice versa), see chapter 8.1.2.4. of the STA Compact ® Operator’s Manual).

❻ Number of functioning hours of STA Compact ® since the last service call

➐ Number of functioning hours of STA Compact ® since the STA Compact ® installation

➑ Number of remaining cuvettes (displayed in black). When it remains 20 cuvettes or less, this
number is displayed in red.

➒ Quantity of STA®-Cleaner Solution remaining (displayed in black).

When it remains 50 milliliters or less, this number is displayed in red.

➓ For the syringe and for the light source (halogen lamp), availability before the next
maintenance (expressed in %).

When the availability reaches 0, a message warns the operator. The number becomes
negative and will be displayed in red if the maintenance is not done.

For the syringe, each result is printed with an alarm message to warn the operator that
the maintenance has not been done.

For the light source, the results have no alarm message because the light intensity level is
always controlled. It is advised to change it as a preventive measure.

Current version of the STA Compact ® software.

8.1.2.2. Modifying the Date

START: SYSTEM STATUS screen.

ACTIONS RESULTS

Press the Esc key (Options). The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit

with the cursor on Quit.

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Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the ↓ key (Change Date), then The TYPE NEW DATE window is displayed:
confirm with the ↵ key.
TYPE NEW DATE

Format mm*dd*yyyy
_

The separator key (*) and the date display

format are defined at the page 2 of 2 of the
GLOBAL OPTIONS screens, see description,
chapter 8.2.3.4. of the STA Compact ®
Operator’s Manual.

Type the new date with respect to the The date is updated.
displayed format and separator then
confirm with the ↵ key. The following window is displayed:
For this example: type the month
(2 characters), the * key, the day Change Date
(2 characters), the * key, the year Change Time
(4 characters), then confirm with the ↵ key. Level Detection Management
Quit

with the cursor on Quit

8.1.2.3. Modifying the Time

START: SYSTEM STATUS screen displayed.

ACTIONS RESULTS

Press the Esc key (Options). The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit

with the cursor on Quit.

Press the ↑ key (Change Time), then The TYPE NEW TIME window is displayed:
confirm with the ↵ key.
TYPE NEW TIME

Format hh*mm*ss

The separator key (*) and the date display

format are defined at the page 2 of 2 of the
GLOBAL OPTIONS screens, see description,
chapter 8.2.3.4. of the STA Compact ®
Operator’s Manual.

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

ACTIONS RESULTS

Type the new time with respect to the The time is updated.
displayed format and separator then
confirm with the key. The following window is displayed:
For this example: type the hour
(2 characters), the * key, the minutes Change Date
(2 characters), the * key, the seconds Change Time
(2 characters), then confirm with the ↵ key. Level Detection Management
Quit

with the cursor on Quit.

8.1.2.4. Modifying the Level Detection Management

START: SYSTEM STATUS screen displayed.

ACTIONS RESULTS

Press the Esc key (Options). The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit

with the cursor on Quit.

Press t h e ↑ k e y (Level Detection The LEVEL DETECTION MANAGEMENT window

Management) then confirm with the ↵ is displayed:
key.
LEVEL DETECTION MANAGEMENT

Needle No.1
Needle No.2
Needle No.3 ↵ Controlled/Not Ctrl.
Esc Quit

with the cursor on Needle No.1.

Press the ↵ key to inhibit the level detection The following warning window is displayed:
of needle No.1, (samples).
WARNING:
Needle No.1 Level Detection
Management
INHIBITION OF CONTROL REQUESTED
-
You must DECANT ALL THE TUBES in the
sample drawer
All results will be flagged
CANCEL CONFIRM

with the cursor on CANCEL.

Decant all the tubes in the sample drawer. The mention “not managed” appears.

Note: Primary tubes should not be used if sample level detection is not managed,
because there is a risk of picking up the cell layer.

V 1.0 - January 96 8-5

Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Then press the → key to CONFIRM then press the ↵ key to validate.

Press the ↓ key to Needle No.2, then The following warning window is displayed:
confirm with the ↵ key to inhibit the level
detection of needle No.2. WARNING:
Needle No.2 Level Detection
Management
INHIBITION OF CONTROL REQUESTED

All results will be flagged

CANCEL CONFIRM

with the cursor on CANCEL.

Press the → key to CONFIRM. then press the ↵ key to validate.

The results will be flagged with an alarm

code.

Press the ↓ key to Needle No.3, then The following window is displayed:
confirm with the ↵ key to inhibit the level
detection of needle No.3. WARNING:
Needle No.3 Level Detection
Management
INHIBITION OF CONTROL REQUESTED

All results will be flagged

CANCEL CONFIRM

with the cursor on CANCEL.

Press the → key to CONFIRM, then press The mention “not managed” appears.
the ↵ key to validate.
The results will be flagged with an alarm
code.

Note: To inform the operator that the level detection management for a needle has been
inhibited, a warning message is displayed upon opening of the sample drawer or upon
opening of the product drawer.

8.1.3. Description of TEST STATUS Screen

Reminder: This screen corresponds to a consistency check between the workload for
STA Compact ® (number of tests to perform except the blocked ones) and the
needs to complete this task:

– products (cuvettes, washing solution, controls, calibrators, diluents, reagents, ...);

– validated calibrations;
– and validated quality controls.

It is displayed:

– upon request from the Status menu;

– during closing of the drawers (sample and product), see chapter 4.12. of the
STA Compact ® Operator’s Manual;

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

– when tests are inserted in the Patient Files from the FILE PROCESSING
screens (Confirmation/Printout/Transmission menu or TEST PANEL), see
description, chapter 6.3. of the STA Compact ® Operator’s Manual;
– when rerunning tests (see chapters 6.3. and 6.7.4. of the STA Compact ®
Operator’s Manual).
– when running calibrations, see chapter 5.3.1. of the STA Compact ®
Operator’s Manual;
– when running quality controls, see chapter 7.4.1. of the STA Compact ®
Operator’s Manual.

If after the consistency check, one of the needs to complete the workload is not met,
then all the sample pipetting (sample plasma, controls and calibrators) will be blocked
and the “BLOCKED SAMPLE PIPETTING” message will be displayed in white on a red
background at the foot of the screen.

In this case, the operator can reactivate the sample pipetting for the tests which meet
all the conditions (correct calibration, quality control, volume and stability for all
requested products) by pressing the ESC key and then the Y key.

Otherwise, if after the consistency check, all conditions are met, then the sample
pipetting continues or starts again, the ESC key returns directly to the TEST PANEL
screen.

This screen is updated every 5 minutes.

Fig. 2 - TEST STATUS Screen

➊ Available functions list:

F6 Prints the data related to this screen;

Esc Returns to the TEST PANEL screen, whether:

– directly if the “BLOCKED SAMPLE PIPETTING” message is not displayed at the foot of
the screen;
– or by through a confirmation window if the “BLOCKED SAMPLE PIPETTING” message
is displayed at the foot of the screen (see description, chapter 4.12. of the STA
Compact ® Operator’s Manual).

➋ Current Date and Time

V 1.0 - January 96 8-7

Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

➌ Title of the screen

➍ For the cuvettes and the washing solution (STA® - Cleaner Solution), quantity currently
available.

➎ For the cuvettes and the washing solution (STA® - Cleaner Solution), quantities which will
theoretically remain after all the assays will be run.
When the values are positive (surplus), they are displayed in grey. When the values are
negative (missing quantity to perform all the assays), they are displayed in red.

❻ Total number of tests (including the blocked tests) that the STA Compact ® has to run
without taking into account calibrations and controls.

➐ Number of pending tests

➑ Estimated end of work (hour and minutes) for the required tests, if all necessary products
(reagents, diluents, controls, Desorb Solutions, or calibrators) have been loaded and if their
stability is not expired. The estimated end of work is updated every 5 minutes, according to
the loading of the products.

• For each product (reagents, diluents, Desorb Solutions, controls, or calibrators) necessary
to complete the required files, there is a line with:

➒ Alphanumeric identification of the product. The symbol (∗) indicates the probability of
stability end before the end of the tests.
➓ Name of the product corresponding to each alphanumeric identification
Indication of the positioning zone of the products: 1 (sample drawer for the diluents) or 2
(product drawer for all the other products). When there are more than one vial for the
same product in the same zone, the volumes of the vials are added and only the addition
will be displayed with the recall of the positioning zone.
Margin: quantity which should theoretically remain after all the assays will be run.
A positive value indicates a surplus, it is displayed in grey.
A negative value indicates missing products, it is displayed in red. These products will
have to be reloaded to allow the STA Compact ® to finish all the tests.
Note: In case of negative values, the zones: 9 (identification) and 10 (name), are also
displayed in red.

The products are sorted by priority order :

– products with negative margin (and eventually with stability problem);
– products with risk of stability overdue;
– products without problem.

When the TEST STATUS screen is displayed, the cursor is positioned on the first
product. The keys: ↓ and ↑ move the cursor from one product to the other one and
so view all of them.

• For each type of test:

Abbreviation of the test.

Current calibration status:
– Not done;
– Running;
– Confirm (to be confirmed);
– Control out (control out of range);
– Validated.

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

Current quality control status:

– Running;
– Out of range;
– Validated;
– Not done.

Note: When the TEST STATUS screen is displayed, the cursor is positioned on the first
product. The key → moves the cursor to the test status area, then the keys: ↑
and ↓ move the cursor from one test to the other one.

The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red background at the
foot of the screen when the sample pipetting is blocked whether:

– voluntarily by the operator (Stop Sample Pipetting function, see description in chapter
8.1.5.1. of the STA Compact ® Operator’s Manual);
– or automatically by the STA Compact ® after the consistency check; if the required
assays cannot be done.

8.1.4. Description of PRODUCT STATUS Screen

Fig. 3 - PRODUCT STATUS Screen

➊ Available functions:

Esc Returns to the TEST PANEL

➋ Current Date and Time.

➌ Title of the screen

➍ Alphanumeric identification of each product (reagents, diluents, desorb solutions, controls or

calibrators) as defined in the TEST SETUP screens (see chapter 3.1. of the STA Compact ®
Operator’s Manual), normally displayed in blue; it will be displayed in red in case of
insufficient volume, liquid level detection problem or expired stability. Products with problems
are listed on top of the list.

➎ Name of each product (reagents, diluents, desorb solutions, controls or calibrators) as

defined in the TEST SETUP screens (see chapter 3.1. of the STA Compact ® Operator’s
Manual).

V 1.0 - January 96 8-9

Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

❻ Position in the sample drawer (D1) or in the product drawer (D2) currently occupied by each
product (reagents, diluents, desorb solutions, controls or calibrators).

➐ Lot number of each product (reagents, diluents, desorb solutions, controls or calibrators)
currently loaded in the sample drawer or in the product drawer.
For some products whose lot number is not managed, this field will be empty.

➑ Current volume of each product (reagents, diluents, desorb solutions, controls or calibrators).

The STA Compact ® takes as starting point the volume of the vial after reconstitution as
specified within the TEST SETUP screens (see chapter 3.1. of the STA Compact ® Operator’s
Manual). Otherwise, this volume can be modified during the loading step (see chapters 4.5.,
4.6. and 4.7. of the STA Compact ® Operator’s Manual).

Subsequently, after each sample has been taken, the vial volume is decreased by the sample
volume as specified in the TEST SETUP screens (see chapter 3.1. of the STA Compact ®
Operator’s Manual).
When the volume reaches the Min. Volume specified in the TEST SETUP screens (see
chapter 3.1. of the STA Compact ® Operator’s Manual), then the Min. Volume value is
displayed in red as well as the alphanumeric identification of the product.
If, compared to the theoretical decrease in volume, the STA Compact ® does not detect the
liquid level, then the displayed volume is 0 in red; the alphanumeric identification of the
required product is displayed in red too, and the product is forbidden.

➒ Theoretical stability end for each product specified with the month, the day and the time.

To calculate this value, the STA Compact ® uses the stability (t) specified in the TEST SETUP
screens (see chapter 3.1. of the STA Compact ® Operator’s Manual). This stability can be
corrected during the loading step (see chapters 4.5., 4.6. and 4.7. of the STA Compact ®
Operator’s Manual).

From the loading of each product (t0) the STA Compact ® does the following sum:

t0 + t = T T = displayed stability end

The displayed color of the stability end and the alphanumeric identification depends on the
following parameters :

Alphanumeric
Current Date and Time Stability End (T)
Identification of Product

Up to T - (1 hour) Blue Blue

From [ T - (1 hour ) ] to T Blue Red

After T Red T changes to Finished

displayed in red

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STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.1.5. Options

8.1.5.1. Stop Sample Pipetting

This option is automatically set to YES by the STA Compact ® if after inserting new assays to
run (sample tubes, controls or calibrations), one of the following conditions is not satisfied:
– sufficient volume;
– no risk of stability overdue;
– calibration done and validated;
– quality control done.

The operator may then decide to unblock some tests (see chapter 8.1.3. of the STA Compact ®
Operator’s Manual) by changing the option to NO.

The operator may also use this option to stop the sample pipetting by changing the option from
NO to YES. In this case, all sample pipetting (including calibrators and controls) is blocked.
However, STA Compact ® finishes the assays in progress for all the cuvettes still on the
incubation plate.

8.1.5.2. On-Line Transmission (YES/NO)

When YES is chosen for this option, the results are then sent one by one to the host computer
as soon as they are obtained, with respect to the conventions described in chapter 6.4.1. of the
STA Compact ® Operator’s Manual.

8.1.5.3. On-Line Printout (YES/NO)

When YES is chosen for this option, the Patient Files are then automatically printed as soon as
all tests of the Patien File have been run.

☞ Caution! If YES is chosen for this option, the other printouts (printout of a file selection...) can
be performed only according to special conditions.

V 1.0 - January 96 8 - 11
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

8.2. GLOBAL OPTIONS Screens

These screens are used to define the parameters specific to the laboratory: address, access,
codes, type of information to be entered into patient files, communication parameters and
miscellaneous.

8.2.1. Access to the GLOBAL OPTIONS Screens

☞ Caution This access is possible only if:

Caution!

– the STA Compact ® is in stand-by mode (no measurements in progress);

– the operator knows the related access code.

START: TEST PANEL displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu is displayed:

Status Loading (...) - Halt

with the cursor on Status.

Press the E key (Setup). The Setup menu is displayed:

Or press the → key to reach Setup, then Tests

confirm with the ↵ key. Global Options

with the cursor on Tests.

Press the G key (Global Options). The following window appears:

Or Press t h e ↓ key to reach Global Please enter

Options, then confirm with the ↵ key. your access code:

↵ : Validate Esc: Quit

Type your access code, then confirm with The first sc reen of GLOBAL OPTIONS
the ↵ key. appears (see description below).

8 - 12 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.2.2. First GLOBAL OPTIONS Screen

8.2.2.1. Description of the First GLOBAL OPTIONS Screen

Fig. 4 - GLOBAL OPTIONS Screen, Page 1 of 2

➊ Available functions:

Esc Opens the EXIT OPTIONS window (see description, chapter 8.2.5. of the STA
Compact ® Operator’s Manual)
PgDn Displays the second screen of GLOBAL OPTIONS.

➋ Date of last saving of the GLOBAL OPTIONS screens.

➌ Title of the screen.

➍ Printout parameters.

➎ Definition of the access codes.

❻ Reading parameters of the bar code reader.

➐ Miscellaneous section.

➑ Definition of the arbitrary units.

Note: The definitions of each parameters are described in the following pages.

8.2.2.2. Printout

Identification of the laboratory as it appears on the printed results.

Title 1 First line for identifying the laboratory

(34 characters)

Title 2 Second line for identifying the laboratory

(34 characters)

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Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

8.2.2.3. Access Codes

The laboratory may decide to restrict access to certain program functions to specified persons.
These functions are the following:

- modification of test setups, creation or deletion of test setups, updating test setups;
- running of calibrations and quality controls, manual validation of calibrations;
- running of calibrations and quality controls, manual validation of calibrations,
acceptance of results out of range for calibration controls and quality controls (in case of
predefined limits overdue), access to critical functions : change ranges for controls,
deletion of control values, etc...
- access to the GLOBAL OPTIONS screens.

The access codes can be defined with 3 alphabetical characters.

☞ Caution! Before defining these codes, please read carefully chapter 1.8.4. of the STA Compact
® Operator’s Manual.

8.2.2.4. Bar Code Reading

If the laboratory uses bar code identification for the patient samples, it may happen that this
latter needs only a part of the bar code digits. In this case, it is possible to define which digits
can be deleted.

Non significant Digit (s) Leading Number of digits to delete on the left and/or
Ending on the right (1 character)

8.2.2.5. Miscellaneous

Default Desorb Alphanumeric identification of the Desorb

(8 characters) Solution to use by default at each STA
Compact ® startup.

Audible Alarm Definition of the required alarm.

Two choices are available:

* YES: audible alarm generated during

the error messages;
* NO: without audible alarm during the
error messages.

8.2.2.6. Arbitrary Units

The laboratory can create up to 3 new units.

Name Unit name.

(5 characters)

Decimal Definition of the number of characters after

the decimal point.
Reminder:Each result is given with 5
characters including the decimal point.
Possible choices: 1,2 or 3.

8 - 14 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.2.3. Second GLOBAL OPTIONS Screen

8.2.3.1. Description of the Second GLOBAL OPTIONS Screen

Fig. 5 - GLOBAL OPTIONS Screen, Page 2 of 2

➊ Available functions:

Esc Opens the EXIT OPTIONS window, see description chapter 8.2.5. of the STA
Compact ® Operator’s Manual;

PgUp Displays the first GLOBAL OPTIONS screen.

➋ Title of the screen

➌ Communication parameters

➍ File acquisition parameters

➎ Miscellaneous section:

– definition of the time display format;

– definition of the date display format.

Note: The definition of each parameter are described in the following pages.

8.2.3.2. Communications

The following parameters are used to define the characteristics necessary for a central computer
connection (ASTM Protocol):

Station Number (0 ... 99) Allows host computer to identify the STA
(2 characters) Compact ®.

Baud Rate Transmission speed, chosen from:

Bauds 300, 600, 1200, 2400, 4800, 9600 Bauds.

Parity Type of parity selected, 3 options: none,

even or odd.

Number of Data Bits Options: 7 or 8.

V 1.0 - January 96 8 - 15
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

Number of Stop Bits Options: 1 or 2.

Number of On Error Retries Number of times the STA Compact ® sends

each frame after receiving a NACK
message. For consistency with standard
E1381-91, this number is set to 6.

Verify Patient Data There are two options:

* YES: The first four fields to identify a

patient file are sent by the host
computer at the same time as the
work list. These fields can be
checked during sample loading (see
File Acquisition, chapter 8.2.3.3. of
the STA Compact ® Operator’s
Manual).

* NO: The first four fields to identify a

patient file are sent by the host
computer at the same time as the
work list. These fields can not be
checked during sample loading (see
File Acquisition, chapter 8.2.3.3. of
the STA Compact ® Operator’s
Manual).

8.2.3.3. File Acquisition

The civil status of patient files is defined in five fields.

The first field ID (field 1) is fixed: 16 alphanumerical characters. The laboratory may define the
other four fields as it wishes, bearing in mind that the number of alphabetical characters per field
is preset as follows:

- field 2: 16 alphanumerical characters;

- field 3: 12 alphanumerical characters;
- field 4: 6 alphanumerical characters;
- field 5: 4 alphanumerical characters.

Only the defined fields can be used.

Concerning the name of each field: it can use 12 characters.

* ID Type

There are two options:

- numeric;
- alphanumeric.

8 - 16 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.2.3.4. Miscellaneous

The following paramaters are used to define:

– the Time display format;
– the Date display format.

Time Format Possible options for the display format:

* 0 - 24 h format;
* 0 - 12 h format.

A chain of format used as acquisition help can also be

defined (example: hh: mm: ss).

Possible options for the separator:

* /
*:
*-
*.
*,

Date Format Possible options for the display format:

* day - month - year format;
* month - day - year format;
* year - month - day format.

A chain of format used as acquisition help can also be

defined (example: dd/mm/yyyy).

Possible options for the separator:

* /
* :
* -
* .
* ,

8.2.4. Modification of a Global Option Parameter

8.2.4.1. Generalities

☞ Caution! This procedure is possible only if:

– the STA Compact ® is in stand-by mode (no measurements in progress);

– the operator knows the access code to the GLOBAL OPTIONS screens.

Morever, modifying some parameters may have very important consequences on:

– reading of the bar codes used for the sample tubes;

– transmission of results to the host computer.

Note: The parameters displayed in grey cannot be modified, only those displayed in blue or in
white can be modified.

V 1.0 - January 96 8 - 17
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

With the cursor positioned on the parameter to modify, there are two options:

– free entry field: In this case, no message is displayed at the foot of the screen, the data
and the cursor are displayed in blue;
– Multiple-option field: In this case, the message “Key DEL = Modification” is displayed
at the foot of the screen. The data and the cursor are displayed in white.
The Delete key makes the possible options whether to pass or to be displayed in a
window (Time format, Date format, type of printer), see modification procedure below,
chapters 8.2.4.3. to 8.2.4.6. of the STA Compact ® Operator’s Manual.

8.2.4.2. Modification Procedure for a Free Entry Field

START: GLOBAL OPTIONS screen displayed (page 1 or page 2), the cursor is positioned on
data displayed in blue.

ACTIONS RESULTS

E n t e r t he n e w i nf o r m a t io n on the New data are displayed.

alphanumeric keyboard, then confirm with
the ↵ key. The cursor moves to the next data.

8.2.4.3. Modification Procedure for a Multiple-Option Field: Passing Method

START: GLOBAL OPTIONS screen displayed (page 1 or 2), the cursor is positioned on a white
parameter and the message “Key DEL = Modification” is displayed at the foot the
screen.

ACTIONS RESULTS

Press the Delete key. The next option appears.

When the selected option is displayed, The selected option is displayed.

press the ↵ key.
The cursor moves to the next parameter.

8.2.4.4. Modification of the Time Display Format

START: GLOBAL OPTIONS screen, page 2 of 2 is displayed with cursor positioned near Time
Format.

ACTIONS RESULTS

Press the Delete key. The TIME FORMAT window appears:

TIME FORMAT

Separator
17∗35∗24
05∗35∗24 p
International Time
17 H 35 M 24 S

with the cursor on Separator.

Display of the separator key (∗) according to

the last choice.

8 - 18 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

• Selection of the Separator Key

START: TIME FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the ↵ key to change the separator The different available separator keys are
key if necessary. displayed in the following window:

/ : - “ ‘

with the cursor on the / key.

Move the cursor to the required separator The TIME FORMAT window appears:
key, then confirm with the ↵ key.
TIME FORMAT

Separator
17∗35∗24
05∗35∗24 p
International Time
17 H 35 M 24 S

with the cursor on Separator.

The separator key (∗) is updated.

• Format: 0 - 24 h

START: TIME FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the↓ key to 17∗35∗24, then confirm T h e TIME ABBREVIATION w in d o w is

with the ↵ key. displayed:

TIME ABBREVIATION

hh∗mm∗ss
(Hours:Minutes:Seconds)

with the cursor positioned on the first

letter of the time display format

Display of the separator key (∗) according

to your last choice.

V 1.0 - January 96 8 - 19
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Check the abbreviations for hour, minute The TIME FORMAT window appears:
a n d s e c o n d , a n d change t h e m if
necessary, then press the ↵ key. TIME FORMAT

Separator
17∗35∗24
05*35*24 p
International Time
17 H 35 M 24 S

with the cursor on 17∗35∗24.

Press the Esc key. Back on page 2 of the GLOBAL OPTIONS

screen with the cursor near Time Format.

The abbreviations for the time format are

updated.

• Format: 0 - 12 h

START: TIME FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the↓ key to 05∗35∗24 p, then T he TIME ABBREVIATION w in d ow is

confirm with the ↵ key. displayed:

Note: p = p-m TIME ABBREVIATION

a = a-m
hh∗mm∗ss
(Hours:Minutes:Seconds)

with the cursor positioned on the first

letter of the time display format.

Display of the separator key (∗) according

to your last choice.

Check the abbreviations for hour, minute The TIME FORMAT window appears:
a n d s e c o n d , a n d change t h e m if
necessary, then press the ↵ key. TIME FORMAT

Separator

17∗35∗24
05∗35∗24 p

International Time
17 H 35 M 24 S

with the cursor on 05∗35∗24 p.

Press the Esc key. Back on the page 2 of the GLOBAL OPTIONS
screen with the cursor near Time Format.

The abbreviations for the time format are

updated.

8 - 20 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.2.4.5. Modification of the Date Display Format

START: GLOBAL OPTIONS screen, page 2 of 2 displayed with the cursor positioned near Date
Format.

ACTIONS RESULTS

Press the Delete key. The DATE FORMAT window appears:

DATE FORMAT

Separator

06∗08∗1993
1993∗08∗06
08∗06∗1993

For Year =1993

Month = 8
Day = 6

with the cursor on Separator.

Display of the separator key (∗) according

to the last choice.

• Selection of the Separator Key

START: DATE FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the ↵ key to change the separator The different available separator keys are
key. displayed in the following window:

/ : - . ,

with the cursor on the / key.

Move the cursor to the required separator The DATE FORMAT window appears:
key, then confirm with the ↵ key.
DATE FORMAT

Separator

06∗08∗1993
1993∗08∗06
08∗06∗1993

For Year = 1993

Month = 8
Day = 6

with the cursor on Separator.

The separator key (∗) is updated.

V 1.0 - January 96 8 - 21
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

• Day∗Month∗Year Format

START: DATE FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the ↓ key to 06∗08∗, then confirm with the T h e DATE ABBREVIATION w in d o w is
↵ key. displayed:

DATE ABBREVIATION

jj∗mm∗aaaa

Example
France jj.mm.aaaa
USA mm/dd/yyyy

with the cursor positioned on the first letter

of the date display format.

Display of the separator key (∗) according

to your last choice.

Check the abbreviations for the day, month The DATE FORMAT window appears:
year, and change them if necessary then
press the ↵ key. DATE FORMAT

Separator

06∗08∗1993
1993∗08∗06
08∗06∗1993

For Year = 1993

Month = 8
Day = 6

with the cursor on Separator.

Press the Esc key. Back on page 2 of the GLOBAL OPTIONS

screen with the cursor near Date Format.

The abbreviations of the date format have

been updated.

8 - 22 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

• Year∗Month∗Day Format

START: DATE FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the ↓ key to reach 1993∗08∗06, then T h e DATE ABBREVIATION w i nd o w is

confirm with the ↵ key. displayed:

DATE ABBREVIATION

aaaa∗mm∗jj

Example
France jj.mm.aaaa
USA mm/dd/yyyy

with the cursor positioned on the first letter

of the date display format.

Display of the separator key (∗) according

to your last choice.

Check the abbreviation for the day, month, The DATE FORMAT window appears:
year, and change them if necessary, then
press the ↵ key. DATE FORMAT

Separator

06∗08∗1993
1993∗08∗06
08*06*1993

For Year = 1993

Month = 8
Day = 6

with the cursor on Separator.

Press the Esc key. Back on page 2 of the GLOBAL OPTIONS

screen with the cursor near Date Format.

The abbreviations of the date format have

been updated.

V 1.0 - January 96 8 - 23
Miscellaneous Screens STA COMPACT ® OPERATOR'S MANUAL

• Month∗Day∗Year Format

START: DATE FORMAT window displayed with the cursor on Separator.

ACTIONS RESULTS

Press the ↓ key to reach 08∗06∗1993, then T h e DATE ABBREVIATION window is

press the ↵ key. displayed:

DATE ABBREVIATION

mm∗jj∗aaaa

Example
France jj.mm.aaaa
USA mm/dd/yyyy

with the cursor positioned on the first letter

of the date display format.

Display of the Separator key (∗) according

to your last choice.

Check the abbreviations for the day, The DATE FORMAT window appears:
m o n t h , y e a r , a nd change t h e m if
necessary, then press the ↵ key. DATE FORMAT

Separator

06∗08∗1993
1993∗08∗ 06
08∗06∗1993

For Year = 1993

Month = 8
Day = 6

with the cursor on Separator.

Press the Esc key. Back on page 2 of the GLOBAL OPTIONS

screen with the cursor near Date Format.

The abbreviations of the date format have

been updated.

8 - 24 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Miscellaneous Screens

8.2.5. Saving Parameters from GLOBAL OPTIONS Screens

START: GLOBAL OPTIONS screen (Page 1 or 2) displayed.

ACTIONS RESULTS

Press the Esc key. The EXIT OPTIONS window is displayed:

EXIT OPTIONS

Saving before quitting

Quit without saving

Do not quit

with the cursor on Save before quitting.

Press the ↵ key. The modifications have been saved.

Display ot the STA Compact ® logo and

check of several parameters: if one
problem is found, an error window will be
displayed.

Back on the TEST PANEL.

V 1.0 - January 96 8 - 25
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 9

9. MAINTENANCE 1

9.1. Preventive Maintenance Schedule 1

9.2. Weekly User Preventive Maintenance 2

9.2.1. Cleaning Air Filters 2
9.2.2. Passing the Mandrel through the Needles and Cleaning the Washing Wells 3
9.2.3. Cleaning Sample and Product Drawers 6
9.2.4. Cleaning the Measurement Plate 6
9.2.5. Peltier Reservoir Check 8
9.2.6. Cleaning the Suction Tip 8

9.3. Monthly User Preventive Maintenance:

Replacement of Syringe Teflon Tip 12

9.4. Quarterly User Preventive Maintenance: Replacing Air Filters 18

9.5. Replacing Components 19

9.5.1. Sampling Needle 19
9.5.2. Suction Tip 27
9.5.3. Halogen Lamp 30
9.5.4. Main Fuses 35
9.5.5. Secondary Fuses 36

9.6. Decontamination Procedure 37

9.7. Maintenance Utility 38

9.7.1. How to Access the User Maintenance Menu 39
9.7.2. Rinsing Pump 41
9.7.2.1. How to Access the Rinsing Pump Menu 41
9.7.2.2. Rinsing Needle No.1, No.2, No.3 41
9.7.2.3. Quit the Rinsing Pump Menu 43
9.7.3. Bar Code Test 43
9.7.3.1. How to Access the Bar Code Test Menu 44
9.7.3.2. To Test the Bar Code Reader 44
9.7.3.3. Quit the Bar Code Test Menu 45
9.7.4. Printer 45
9.7.4.1. How to Access the Printer Menu 45
9.7.4.2. Connection Checking 45
9.7.4.3. Test of the Characters 46
9.7.4.4. Graphics 46
9.7.4.5. Quit the Printer Menu 47
9.7.4.6. Printer Configuration 48

V 1.0 - February 01
Table of Contents, Chapter 9 STA COMPACT ® OPERATOR'S MANUAL

9.7.5. Saving 49
9.7.5.1. How to Access Saving Menu 49
9.7.5.2. Selection of Items 50
9.7.5.3. Load 50
9.7.5.4. Save 51
9.7.5.5. Format a diskette 53
9.7.5.6. Quit the Saving Menu 53
9.7.6. Maintenance 53
9.7.6.1. How to Access the Maintenance Menu 54
9.7.6.2. Needle Purge 54
9.7.6.3. Needle Replacement 55
9.7.6.4. Syringe Tip/Syringe Replacement 56
9.7.6.5. Suction Tip Replacement 56
9.7.6.6. Halogen Lamp Replacement 57
9.7.6.7. Dates of Recent Maintenance 58
9.7.6.8. Quit the Maintenance Menu 59
9.7.7. Photometry Graphics 59
9.7.7.1. How to Access the Photometry Graphics Menu 59
9.7.7.2. To Eliminate Points 62
9.7.7.3. STA Compact ® Calculation 62
9.7.7.4. Print the Curve 62
9.7.7.5. Print List of Measurement Values 62
9.7.7.6. Change Limits of the Window Calculation 63
9.7.7.7. Load Another Measurement File 63
9.7.7.8. Quit the Photometry Graphics Menu 63
9.7.8. Error History 64
9.7.8.1. How to access the Error History Menu 64
9.7.8.2. Parameter Selection 65
9.7.8.3. Quit the Error Message Menu 65
9.7.9. Host Computer Communications 65
9.7.10. DATA UPDATE 66
9.7.11. Return to the Main Menu 68

V 1.0 - February 01
9.
9.1.

FREQUENCY SPARE PARTS

a day:

Weekly Monthly Every 4 Month Item Qty per Package Catalog No.

V 1.0 - December 99
Teflon Tips and - Replacement - Syringe Piston Tip 6 of each 27530
O-rings for Syringe Recommended and O-ring
MAINTENANCE
STA COMPACT ® OPERATOR'S MANUAL

Air Filters Cleaning - Replacement 100L Air Filter 2 27420

(in back of STA Photometry Filter 1 26538 or
Compact ® and 38125 see p 18
Optical Module)

Mandrel Passage Cleaning - - - - -

Preventive Maintenance Schedule

through Needles and

Washing Wells

Measurement Plate, Cleaning - - - - -

Drawers

For all maintenance operations, see detailed procedure below.

Suction Tip Cleaning - - - - -

Peltier Reservoir Check - - - - -

Maintenance by - - Preventive - - -
Authorized Service Maintenance
Representative
This maintenance schedule is recommended for a laboratory performing more than 200 tests
Maintenance

9-1
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.2. Weekly User Preventive Maintenance

9.2.1. Cleaning Air Filters

Purpose: To prevent internal overheating.

Procedure:
– Switch off the STA Compact ® (see Power-off procedure, chapter 2.6.2. of STA Compact ®
Operator’s Manual);
– Remove the air filter on the back of the STA Compact ®;
– Open the right side of the STA Compact ® and remove the air filter from the optical
module.

Air Filter

Figure 1 - Location of the Air Filters

– Remove the debris from the filters;

– Vacuum the dust;
– Reinstall the air filters;

☞ Caution! Ensure that filters are correctly re-installed: the word EXTERIEUR should face
outwards.
– Switch the STA Compact ® back on.

9-2 V 1.0 -January 96

STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.2.2. Passing the Mandrel through the Needles and Cleaning the Washing Wells

Purpose: – To check the needle and unclog if necessary.

– To clean the wells and the downstream rinse circuits (Vacuum Reservoir) to
ensure perfect suction and avoid contamination on the outside of the needles.

CAUTION! Observe the proper precautions for handling biohazardous

materials in accordance with local existing regulations: use
disposable gloves and observe decontamination procedure (see
below).

START: TEST PANEL screen displayed:

ACTIONS RESULTS

Access the User Maintenance menu

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y t o r e a c h Initializing
Maintenance, then press the ↵ key to Please wait...
confirm.

T h e n , t h e User Maintenance menu

appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

Access the Maintenance menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.

Initialization in progress
Please wait...

V 1.0 - January 96 9-3

Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

Access the Needle Purge menu:

Press the ↵ key Needle Purge. The NEEDLE PURGE screen appears.

The following windows appear:

Checks in progress
Please wait...

Home position in progress

Please wait...

Positioning in well
Please wait...

Press the F6 key. The following window appears :

Open Drawer
Please wait...

The product drawer is opening.

The pipetting head moves forwards.

Raise the transparent panel. Cleaning of wells in progress.

Fill each washing well to 3/4 full with a Mandrel passed through each needle,
1:10 dilute bleach solution. This solution transparent panel lowered.
is obtained with 1 volume 5% sodium
hypochlorite and 9 volumes water. Be
careful that the wells do not overflow on
the electrical parts.

Wait for 10 minutes.

During the waiting time, p a s s t h e

mandrel (metal rod supplied with each
new needle) through each needle.

Lower the transparent panel.

9-4 V 1.0 - January 96

STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the F6 key. The following window appears :

Close Drawer
Please wait...

The product drawer is closing.

The pipetting head moves above the

washing wells and the needles go down
in their wells.

Press the F1 key. Purge of Needle No.1.

Press the F2 key. Purge of Needle No.2.

Press the F3 key. Purge of Needle No.3.

Quit the NEEDLE PURGE screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
Y/N?
Esc = Cancel

Press the Y key. Home positions of the arms.

The Maintenance menu appears.

Access the DATES OF RECENT MAINTENANCE The DATES OF RECENT MAINTENANCE screen
screen: appears.

Press the ↓ key to reach DATES OF

RECENT MAINTENANCEthen confirm with
the ↵ key.

Press the keys ALT and PrtSc. P r i n t o u t o f th e D A T E S O F R E C E N T

MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE

screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
YIN?

ESC = Cancel

Press the Y key. The Maintenance menu displays.

Press t he ↑ k e y t o Return to the Back to User Maintenance menu.

Previous Menu, then confirm with the
↵ key.

V 1.0 - January 96 9-5

Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Return to the Main Menu:

Press t h e ↑ Key to Return to the Same results as described in chapter 2.1.

Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual.
↵ key.

Run quality controls for the routine tests. If the quality control results are consistent
with the previous ones, STA Compact ®
can be used.

Compare results with the previous ones. If not, redo the procedure.
In case of problem, call your local
authorized Service Representative.

Mandrel Decontamination Procedure:

– Prepare a 1:10 dilution of 5% sodium hypochlorite;
– Dip the mandrel into this solution;
– Allow to stand at least 30 minutes;
– Remove the mandrel, rinse it and dry it.

9.2.3. Cleaning Sample and Product Drawers

Purpose: To prevent accumulation of dirt.

START: TEST PANEL screen displayed (as described in Chapter 2.1. of the STA Compact ®
Operator’s Manual.

CAUTION! Observe the proper precautions for handling biohazardous

materials in accordance with local existing regulations: use
disposable gloves.

– Open sample drawer by pressing the F1 key;

– Clean the top with a soft cloth or paper tissue slightly moistened with warm water. Wipe with
a dry cloth;
– Close sample drawer (see chapter 4.12 of the STA Compact ® Operator’s Manual);
– Open product drawer by pressing the F2 key and repeat the cleaning procedures;

☞ Caution! If a sample tube or a product vial (reagent, control, calibrator, dilution buffer) has
been broken, remove the drawer holding clip, pull the drawer cassette upwards, clean
with a 1:10 dilution of 5% sodium hypochlorite, rinse it, dry it, replace it then place
back the drawer holding clip.

9.2.4. Cleaning the Measurement Plate

Purpose: To prevent accumulation of dirt.

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

9-6 V 1.0 -March 98

STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y t o r e a c h Initializing
Maintenance, then press the ↵ key to Please wait...
confirm.

T h e n , t h e User Maintenance menu

appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

CAUTION! Observe the proper precautions for handling biohazardous

materials in accordance with local existing regulations: use
disposable gloves.

– Raise the transparent panel;

– Remove from each measurement cell and each incubation cell any debris;
– Clean each measurement cell and each incubation cell with cotton-tips soaked in ethanol.
Do not use acetone nor trichlorethylene;
– Clean the black panel of the measurement plate with a soft cloth or paper tissue slightly
moistened with warm water, then wipe with a dry cloth. Do not use ethanol on the
measurement plate.

☞ Caution! With the measurement plate, do not allow water to run into the measurement and
incubation wells.

ACTIONS RESULTS

Return to the Main Menu:

Press the ↑ key to Return to the Same results as described in chapter 2.1.
Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual.
↵ key.

Run quality controls for the routine tests. If the quality control results are consistent
with the previous ones, STA Compact ®
can be used.

Compare results to the previous ones. If not, redo the procedure.

In case of problem, call your local
authorized Service Representative.

V 1.0 - January 96 9-7

Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.2.5. Peltier Reservoir Check

Purpose: To avoid the thermal runaway of the cooling liquid circuit.

– Open the right side of STA Compact ®;
– Check that the liquid level in the Peltier reservoir is above the mark indicated on the
bottle.

Peltier
Reservoir

Fig. 2 : Location of the Peltier Reservoir

– If the liquid level is below the mark, switch off the STA Compact ®;
– Open the Peltier Reservoir;
– Fill it with the cooling liquid (Ref.: S-0091218)*;

*CAUTION! The product is harmful by inhalation or ingestion. It contains

methanol: wear protective eyeglasses and appropriate
clothings (e.g. gloves) while handling product (See security data
sheet, chapter 1.8.6.)
Elimination: This product and its waste bottle must be eliminated
in accordance with local, regional and national legislation. The
fluid must not be disposed of down the drain without checking the
legislations in force.

– Switch on the STA Compact ®.

9.2.6. Cleaning the Suction Tip

Purpose: To prevent accumulation of dirt inside the suction tip and thus to limit the suction
errors.

Note: The Suction Tip Replacement menu is used, the procedure is abandoned before
the end.

ACTIONS RESULTS

Access the User Maintenance menu:

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

9-8 V 1.0 -February 01

STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y to r e a c h Initializing
Maintenance, then press the ↵ key to Please wait ...
confirm.
The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

Access the Maintenance menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

Access the Suction Tip Replacement

menu:
The following window displays:

Press the ↓ key to reach Suction Tip Initializing...

Replacement, then confirm with the ↵
key.
T h e Suction Tip Replacement menu
appears:

Suction Tip Replacement

Suction Tip Test
Return to Previous Menu

with the cursor on Suction Tip Replacement.

V 1.0 -January 96 9-9

Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Access the Suction Tip Replacement

menu:

Press the ↵ key Suction Tip The following window displays:

Replacement.
SUCTION TIP REPLACEMENT

For this operation, you must have:

- a new suction tip

F10 : Continue - Esc : Abort

Press the F10 key. Home positions.

Suction head moves forwards.

The following screen appears:

SUCTION TIP REPLACEMENT

Once the transparent panel is raised,

you can replace the suction tip
according to the procedure described in
the manual. When this operation is
finished, validate by pressing F10.
F10 : Validate - Esc : Cancel

• Dismantling, Cleaning and Reassembly of the Suction Tip.

Procedure:

Caution! Observe the proper precautions for handling biohazardous materials

in accordance with local existing regulations: use disposable
gloves.

– Raise the transparent panel;

– Remove the cuvette disposal drawer;
– Remove the suction tip by pulling from the top;
– Clean the suction tip with warm water;
– Dry it;
– Fit the new suction tip which should fit snugly against the suction head;
– Replace the cuvette disposal drawer.

9 - 10 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the Esc key. The following window appears:

SUCTION TIP REPLACEMENT

The procedure has been aborted.

Before resuming, verify that all
is correct; if not, please
restart the procedure.

Press a key...

Press any key. The Suction Tip replacement menu

appears.

Press the ↓ key to Suction Tip Test The following window appears:
then confirm with the ↵ key.
Home position in progress

Test of the suction tip on the measurement plate.

The following window appears:

SUCTION TIP REPLACEMENT

The procedure was

successful :
Detection has succeeded
Space Bar to proceed ...

Press the Space Bar to proceed T h e Suction Tip Replacement menu

appears

Press the ↑ key to Return to Previous The Maintenance menu appears.

Menu, then confirm with the ↵ key.

Press the ↑ key to Return to Previous The User Maintenance menu appears.
Menu, then confirm with the ↵ key.

Return to the Main Menu:

Press the ↑ key to Return to the Same results as described in chapter 2.1.
Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual.
↵ key.

V 1.0 - January 96 9 - 11
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.3. Monthly User Preventive Maintenance: Replacement of Syringe Teflon Tip

• Cat. No.: 27530 (contains 6 Teflon tips and 6 O-rings).

Purpose: To optimize pipetting for each arm and prevent leaks.

☞ Caution! It is recommended that this replacement be performed monthly, although this

frequency can be adjusted depending on the laboratory workload. In any event, do
not exceed the software-controlled limits, the latter being shown in the SYSTEM STATUS
screen, see description in Chapter 8.1.2.1. of this STA Compact ® Operator’s Manual
.

If the entire syringe has to be replaced, do not use other syringes that those supplied
by Diagnostica Stago (Cat. No.: 27538); this would lead to wrong results.
START: TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

Press the M key: Maintenance. The following window appears:

Or press t h e → k e y t o r e ac h Initializing
Maintenance, then press the ↵ key to Please wait ...
confirm.

The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous
MenuF"Helvetica"P10

with the cursor on Rinsing Pump.

Access the Maintenance menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

9 - 12 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

A cc e s s t h e Syringe Tip/Syringe The following window displays:

Replacement menu:

Press the ↓ key to Syringe Tip/Syringe

Replacement menu then confirm with Initializing
Please wait...
the ↵ key.

The Syringe Tip/Syringe Replacement

menu appears:

Tip or Syringe
Return to Previous Menu

with the cursor on Tip or Syringe.

Press the ↵ key. The following window displays:

REPLACEMENT OF TIP OR SYRINGE

For this operation, you must have:

- a newTeflon syringe tip or a new
syringe

F10 : Continue - Esc : Abort

Take a new syringe tip or a new syringe The following window appears:
according to the element which has to be
changed. REPLACEMENT OF TIP OR SYRINGE

Home position in progress...

Please wait ...

Press the F10 key to proceed. REPLACEMENT OF TIP OR SYRINGE

Arm movement
towards washing well
Please wait ...

V 1.0 - January 96 9 - 13
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

The following window appears:

REPLACEMENT OF TIP OR SYRINGE

Y ou can change the tip or the syringe

according to the procedure described
in the manual.
When this operation is finished,
validate by pressing F10.
F10 : Validate - Esc : Abort

– Follow the steps shown in help diagram No. 3 (see Figure 3), this help diagram can be
found inside the right side door in a plastic sleeve. For instruments with serial number
higher than xxx1219, it can be found inside the right door.
Procedure:
– Step 1 : open the right door of the STA Compact ®;
– Step 2 : Lower the syringe piston and loosen the bottom milled screw;
– Step 3 : Unscrew the syringe from its support;
– Step 4 : Remove the syringe from its clamp;
– Step 5 : ➀ Pull the piston out of the syringe ;
➁ Remove the O-ring;
➂ Remove the Teflon tip with fingernails or a blunt instrument;
– Step 6 : Place the new tip on a flat surface as shown in the diagram and press the
syringe piston fully home into the new tip.

☞ Caution! Ensure that the tip remains vertical during this operation.

– Step 7 : ➀ Dip the Teflon tip in distilled water;

➁ Reinstall the piston in the syringe;
➂ Replace the O-ring;

☞ Caution! To forget to replace the O-ring will lead to wrong results.

– Step 8 : Reposition the bottom of the syringe in the clamp while holding it vertically;
– Step 9 : Screw the syringe on its support by hand, still holding it vertically;
– Step 10 : Once again position the piston syringe in the upper position;
– Step 11 : Retighten the milled screw by hand, while maintaining the clamp with the
other hand.
Note : Do not close the right door since a test is going to be performed on the syringe by the
software.

9 - 14 V 1.0 - February 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

3 9, rue des Frères Chausson

92600 Asnières (France)

1 2 5 6 9 10

3
DIAGN
STAGOOSTICA

3 4 7 8 11 12
3

H2O

2
0931026

Fig. 3 - Help Diagram No.3

(Replacement of the Syringe Teflon Tip)

ACTIONS RESULTS

Press the F10 key to validate this The following screen appears:
procedure.
REPLACEMENT OF TIP OR SYRINGE

You have replaced the tip or the

syringe. This is installed on its
support. To ensure that all has been
performed correctly, do a Fluidics
circuit purge.
Please monitor the syringe during this
purge. If leaks appear, press Alt-F10
to stop everything.
F10 to continue

V 1.0 -January 96 9 - 15
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the F10 key to proceed. The following window appears:

Note: Observe the syringe during the REPLACEMENT OF TIP OR SYRINGE

purge and press the Alt + F10 keys
simultaneously in case of problem. Fluidics circuit purge in process,
please monitor the syringe.
Alt-F10 : Emergency Stop

The following windows appears:

REPLACEMENT OF TIP OR SYRINGE

Hom e position in progress ...

Please wait ...

REPLACEMENT OF TIP OR SYRINGE

If a problem
occurred during circuit purge,
please perform the procedure again

Space Bar to proceed

The purge is effected.

If any problem occurs, perform once again

the fluidics circuit purge.

Press the Space Bar to proceed. The related pipettor timer is reset to zero
(see SYSTEM STATUS screen).

The Syringe Tip/Syringe Replacement

menu appears.

Press the ↓ key to reach Return to The Maintenance menu appears.

Previous Menu then confirm with the ↵
key.

Access the DATES OF RECENT MAINTENANCE The DATES OF RECENT MAINTENANCE screen
screen: appears.

Press the ↓ key to reach DATES OF

RECENT MAINTENANCEthen confirm with
the ↵ key.

Press the keys ALT and PrtSc. Printout of t h e D A T ES O F R E C ENT

MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE

screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
YIN?

ESC = Cancel

9 - 16 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the Y key. The Maintenance menu displays.

Press the ↑ key to reach Return to The User Maintenance menu appears.
Previous Menu, then confirm with the
↵ key.

Return to the Main Menu:

Press t h e ↑ k e y to Return to the Same results as described in chapter 2.1.

Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual
↵ key.

Run quality controls for the routine tests. If the quality control results are consistent
with the previous ones, STA compact ®
can be used.

Compare results to the previous ones. If not, redo the procedure.

In case of problem, call your local
authorized Service Representative.

V 1.0 - January 96 9 - 17
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.4. Quarterly User Preventive Maintenance: Replacing Air Filters

• Cat. No.: 27420, air filter for rear panel (2 per bag).

• Cat. No.: 26538, filter for optical module

• Cat. No.: S-0301262/38125, filter for optical module

– Switch off the STA Compact ® (see Power-off procedure, chapter 2.6.2. of STA
Compact ® Operator’s Manual);
– Remove all the air filters and throw them away: on the back of the STA Compact ® and in
the optical module;
– To access the optical module: open then right side.

Air Filter

Fig. 4 - Location of the Air Filters

– Fit the new filters;

☞ Caution! Ensure that filters are correctly re-installed: the word EXTERIEUR should face
outwards.
– Switch the STA Compact ® back on.

9 - 18 V 1.0 - December 99
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.5. Replacing Components

The following components should be replaced whenever they become faulty.

9.5.1. Sampling Needle

• Cat. No.: S-999BA00 for needle No.1

• Cat. No.: 27354 for needle No.2
• Cat. No.: 27307 for needle No.3

The needles are supplied with a Teflon tubing.

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y t o r e ac h Initializing
Maintenance, then press the ↵ key to Please wait ...
confirm.

The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

Access the Maintenance menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

V 1.0 -November 98 9 - 19
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

Access the Needle Replacement menu:

Press t h e ↓ k e y to r ea c h Needle The following window displays:

Replacement, then confirm with the ↵
key. Initializing
Please wait...

The Needle Replacement menu appears:

Needle No. 1
Needle No. 2
Needle No. 3
Return to Previous Menu

with the cursor on Needle No. 1.

Select the needle which has to be

changed:
The following window displays:
* Press the ↵ key for the Needle No. 1
NEEDLE REPLACEMENT
* Press the ↓ key to Needle No. 2 then
For this operation, you must have:
confirm with the ↵ key
- a new needle
* Press the ↓ key to reach Needle No.3 - the mapping cuvette

then confirm with the ↵ key. F10 : Continue - Esc : Abort

Take a new needle and the mapping Home positions in progress.

adjustment cuvette.

Then press the F10 key to proceed. The following window displays :

NEEDLE REPLACEMENT

Drawer is going to open

Press any key
to proceed

Press any key to proceed. Opening of the Product Drawer.

Pipetting head moves forwards.

9 - 20 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

The following window displays:

NEEDLE REPLACEMENT

Once the transparent panel is raised,

you can change the needle according
to the procedure described in the
manual. When this operation is
finished, validate by pressing F10.
F10 : Validate - Esc : Abort

•Dismantling of the Sampling Needle

Caution! Observe the proper precautions for handling biohazardous materials

in accordance with local existing regulations: use disposable gloves
and observe elimination procedure (see below).

Procedure
– Raise the transparent panel;
* For Needles No.1 and No.2:
– Disconnect the tubing from the junction wire at the top of the head as shown in figure 5
below.

Junction Wire

Fig. 5 - Dismantling of the Junction Wire

(Needles No.1 and No.2)

– At the bottom of the needle holder assembly, fully unscrew the milled nut and remove it
(see Fig. 6 below);
– Lower the needle-tubing assembly by gently pushing on the top of the tubing;
– Remove the needle-tubing assembly;
– Dispose of the milled nut and this assembly in accordance with the regulation applicable
locally for the collection needles. Incineration is recommended in most countries.

V 1.0 - January 96 9 - 21
Maintenance STA COMPACT ® OPERATOR'S MANUAL

* For Needle No.3:

– Do not disconnect the tubing at the top of the head;

– Fully unscrew the milled nut at the bottom of the needle holder assembly (see figure 6
below);
– Remove this nut;
– Then pull on the needle to disconnect the small tubing from the union as shown in the figure
7 below:

Fig. 6 - Needle and Milled Nut

– Remove the assembly of needle and small tubing;

– Dispose of the milled nut and this assembly in accordance with the regulation applicable
locally for the collection needles. Incineration is recommended in most countries.
• Re-Assembly of the Sampling Needle:
* For Needles No.1 and No.2:
Note: • Cat. No.: S-999BA00 for needle No.1
• Cat. No.: 27354 for needle No.2 (delivered with the milled nut)
– Push the tubing into the needle holder from below;
– Check that the tubing is not stuck in the needle holder;
– Fully retighten the milled nut by hand while holding the needle holder with the other
hand;
– Reconnect the tubing to the metal union at the top of the head (see figure 5 above).

9 - 22 V 1.0 - November 98
STA COMPACT ® OPERATOR'S MANUAL Maintenance

* For Needle No.3:

Note: • Cat. No.: 27307 for needle No.3 (delivered with the milled nut)

Heating Tube

Needle No.3

Fig. 7 - Needle No.3

– Attach the tubing of the needle to the heating tube fully home (see figure 7 above);
– Push the assembly fully home into the needle holder;
– Fully retighten the milled nut by hand.

* For all Needles:

– Check the positioning of the tubing and cables at the top to avoid any interference with arm
movements;
– Check the connections of the level detection cable from the needle holder to the electronic
circuit board;
– Remove the metal mandrel from inside the needle and keep it for future cleaning or
unclogging the needle.

=> Replacement is completed.

ACTIONS RESULTS

Press t he F10 key to validate this Needle replacement is validated.

procedure.
The following window displays only if the
level detection for the required arm is
managed:

NEEDLE REPLACEMENT

Level detection test.

Please use finger to touch the needle
you have just installed.
You have 19 seconds ...

V 1.0 -January 96 9 - 23
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Take the needle with your fingers (there The following screen displays whether
is no possible contamination: it is a new the level detection is managed or not:
needle).

☞ Caution! There are only 20 seconds to NEEDLE REPLACEMENT

perform this operation.

Please follow these instructions:

1° Place the mapping cuvette in

the incubation position No.16.

2° Lower the transparent panel.

F10 to continue

Place the mapping adjustment cuvette in Home positions.

the incubation position No.16 (see
Chapter 1. of the STA Compact ®
Operator’s Manual).

Lower the transparent panel. The following window appears:

Press t h e F10 key to validate this NEEDLE REPLACEMENT

procedure.

Please follow these instructions:

1° Raise the transparent panel.

2° Adjust the X and Y positions

of the needle with keyboard.

3° When the adjustment is finished,

validate.

↑ / ↓ : Y adjustment - ← / →: X adjustment
F10 : Validation

Raise the transparent panel.

Lower manually the selected needle The following window appears:

holder to see if the needle can enter into
the middle hole of the mapping adjustment NEEDLE REPLACEMENT
cuvette.

* If YES, press the F10 key.

*If NO, twist the needle until it can enter Manually adjust the Z position.
into the middle hole of the mapping Lower the transparent panel, then
adjustment cuvette, then confirm with validate with F10 when all is finished.
the F10 key.

Note: DO NOT USE the moving cursor

keys (↑, ↓, ←, →) to move the needle F10 : Validation
AND DO NOT MOVE the needle holder
along the X and Y axis during these
adjustments.

9 - 24 V 1.0 -November 97
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Plunge the needle to the bottom of the Home positions.

middle hole of the mapping adjustment
cuvette.

Lower the transparent panel. Then, the following window appears:

Press the F10 key to validate the above NEEDLE REPLACEMENT

operations.
Drawer is going to close,
Press any key
to proceed

Press any key to close the product The Drawer is closing

drawer.
The following window appears:

NEEDLE REPLACEMENT

P lease raise transparent panel

to retrieve mapping cuvette.
Then lower transparent panel.

F10 to proceed

Raise the transparent panel. The following window displays:

Retrieve t h e m a p pi ng a d ju s t m e n t NEEDLE REPLACEMENT

cuvette.
The procedure was
Lower the transparent panel. successful.

Press the F10 key to validate the above F10 to proceed

operations.

Press the F10 key to proceed The Needle Replacement menu appears

Press the ↑ key to Return to Previous The Maintenance menu appears.

Menu, then confirm with the ↵ key.

Access the Needle Purge menu:

Press the ↵ key Needle Purge. The NEEDLE PURGE screen appears.

Home positions.

The needles go to their own washing

wells

Needle 1 Purge:

Press the F1 key. Purge of Needle No. 1.

Needle 2 Purge:

Press the F2 key. Purge of Needle No. 2.

V 1.0 - January 96 9 - 25
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Needle 3 Purge:

Press the F3 key. Purge of Needle No. 3.

Quit the Needle Purge menu:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
Y/N ?
Esc = Cancel

Press the Y key. Home positions.

The Maintenance menu appears.

Access the DATES OF RECENT MAINTENANCE The DATES OF RECENT MAINTENANCE screen
screen: appears.

Press the ↓ key to reach DATES OF

RECENT MAINTENANCEthen confirm with
the ↵ key.

Press the keys ALT and PrtSc. Printout of t h e D A T ES O F R E C ENT

MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE

screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
YIN?

ESC = Cancel

Press the Y key. The Maintenance menu displays.

Press t h e ↑ k e y t o Return to the Back to User Maintenance menu.

Previous Menu, then confirm with the
↵ key.

Return to the Main Menu:

Press t h e ↑ key to Return to the Same results as described in chapter 2.1.

Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual
↵ key.

Run quality controls for the routine tests. If the quality control results are consistent
with the previous ones, STA Compact ®
can be used.

Compare results to the previous ones. If not, redo the procedure.

In case of problem, call your local
authorized Service Representative.

9 - 26 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.5.2. Suction Tip

• Cat. No.: 27421 (supplied in pairs).

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y t o r e ac h Initializing
Maintenance, then press the ↵ key to Please wait ...
confirm.
The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

Access the Maintenance menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

V 1.0 - January 96 9 - 27
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Access the Suction Tip Replacement

menu:
The following window displays:
Press the ↓ key to reach Suction Tip
Replacement, then confirm with the ↵ Initializing...
key.
T he Suction Tip Replacement menu
appears:F"Helvetica"

Suction Tip Replacement

Suction Tip Test
Return to Previous Menu

with the cursor on Suction Tip

Replacement.

Access the Suction Tip Replacement

menu:

Press the ↵ key Suction Tip The following window displays:

Replacement.
SUCTION TIP REPLACEMENT

For this operation, you must have:

- a new suction tip

F10 : Continue - Esc : Abort

Take a new suction tip then press the Home positions.

F10 key.
Suction head moves forwards.

The following screen appears:

SUCTION TIP REPLACEMENT

Once the transparent panel is raised,

you can replace the suction tip
according to the procedure described in
the manual. When this operation is
finished, validate by pressing F10.
F10 : Validate - Esc : Cancel

• Dismantling and Reassembly of the Suction Tip

Procedure:

Caution! Observe the proper precautions for handling biohazardous materials

in accordance with local existing regulations: use disposable
gloves.

– Raise the transparent panel;

– Remove the cuvette disposal drawer;
– Remove the suction tip by pulling from the top;
– Dispose of the suction tip. Incineration is recommended in most countries;
– Fit the new suction tip which should fit snugly against the suction head;

9 - 28 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

Fig. 8 - Replacement of the Suction Tip

– Replace the cuvette disposal drawer.

ACTIONS RESULTS

Press t h e F10 key to validate the The following window appears:

replacement.
SUCTION TIP REPLACEMENT

You have replaced the suction tip.

Please lower the transparent panel in
order to run automatic
tests that are necessary to validate
the installation.
F10 to validate the installation

Lower the transparent panel, then press The following window appears:
the F10 key to run the suction test.
Home position in progress

Test of the suction tip on the measurement

plate

The following window appears:

SUCTION TIP REPLACEMENT

The procedure was

successful:
Detection has succeeded
Space Bar to proceed ...

Note: If the test does not succeed, redo

the procedure, remove then replace the
suction tip:
* remove the suction tip;
* check that it is not damaged;
* if damaged, replace it;
* if in good shape, re-install it and redo
the test.

V 1.0 - January 96 9 - 29
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the Space Bar to proceed. T he Suction Tip Replacement menu

appears.

Press the ↑ key to Return to Previous The Maintenance menu appears.

Menu, then confirm with the ↵ key.

Access the DATES OF RECENT MAINTENANCE The DATES OF RECENT MAINTENANCE screen
screen: appears.

Press the ↓ key to reach DATES OF

RECENT MAINTENANCEthen confirm with
the ↵ key.

Press the keys ALT and PrtSc. Printout of t h e D A T ES O F R E C ENT

MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE

screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
YIN?

ESC = Cancel

Press the Y key. The Maintenance menu displays.

Press the ↑ key to Return to Previous The User Maintenance menu appears.
Menu, then confirm with the ↵ key.

Return to the Main Menu:

Press t h e ↑ k e y t o Return to the Same results as described in chapter 2.1.

Previous Menu, then confirm with the of the STA Compact ® Operator’s Manual.
↵ key.

9.5.3. Halogen Lamp

• Cat. No.: 26699

START: TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the M key: Maintenance. The following window appears:

O r press t h e → k e y t o r e ac h Initializing
Maintenance, then press the ↵ key to Please wait ...
confirm.
The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

Access the Maintenance

menu:

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

Access the Halogen Lamp Replacement

menu:

Press the ↓ key to reach Halogen Lamp The following window displays:
Replacement, then confirm with the ↵
key. Initializing ...

The Halogen Lamp Replacement menu

appears:

Lamp Replacement
Lamp Test
Return to Previous Menu

with the cursor on Lamp Replacement.

V 1.0 -January 96 9 - 31
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the ↵ key to Lamp Replacement. The following window displays:

LAMP REPLACEMENT

For this operation, you must have:

- a new halogen Lamp
- a screwdriver

F10 : Continue - Esc : Abort

Take a philips screwdriver and a new The following window displays:

halogen lamp.

Press the F10 key. HALOGEN LAMP REPLACEMENT

You can replace halogen lamp

according to the procedure described in
the manual
Caution!
The lamp may be hot!
F10 : Validate - Esc : Abort

• Dismantling of the halogen Lamp:

Procedure:

☞ Caution! The lamp holder may still be hot, allow the lamp to cool before removal.

– Open the right side of the STA Compact ®;

– Loosen the milled screw (item 2 on figure 9) by hand in order to remove the small door (item 1,
figure 9);
– Unplug the connector (item 3, figure 9);
– Slacken the two screws (items 4, figure 9) at the base of the lamp holder using a philips
screwdriver;
– Hold the lamp holder by hand and release it from the two remaining screws.

4 3

1 2

Fig. 9 - Dismantling of the Lamp Holder

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

– Use dry paper tissue or cloth to remove the lamp from its holder by hand.

Fig. 10 - Dismantling of the Halogen Lamp

• Re-assembly of the Halogen Lamp:

– Fit the new lamp to its holder (see figure 10).

☞ Caution! Do not touch the new lamp with bare fingers. Always use paper tissue or dry cloth.

– Reinstall the lamp holder, engaging the two screws remaining on the base in its openings;
– While tightening the two lamp holder mounting screws, hold the lamp in such a way as to
press it against the light “gun” (towards the bottom of the optical module);
– Plug in the connector;
– Reinstall the small door and tighten the milled screw by hand;
– Close the right side of the STA Compact ®.

ACTIONS RESULTS

Press the F10 key to validate the lamp The following window displays:
replacement.
HALOGEN LAMP REPLACEMENT

You have replaced the lamp.

Please validate in order to
perform a photometric test
F10 to start test

Press the F10 key. Halogen lamp test in process.

At the end of this test, the following window

appears:

LAMP REPLACEMENT

The procedure was

successful
Space Bar to proceed ...

The lamp timer is reset to zero (see SYSTEM

STATUS screen).

If a problem occurs during the procedure,

redo the procedure.

Press the Space Bar to proceed. The Halogen Lamp Replacement menu
appears.

Press the ↑ key to Return to Previous The Maintenance menu appears.

Menu, then confirm with the ↵ key.

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Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Access the DATES OF RECENT MAINTENANCE The DATES OF RECENT MAINTENANCE screen
screen: appears.

Press the ↓ key to reach DATES OF

RECENT MAINTENANCEthen confirm with
the ↵ key.

Press the keys ALT and PrtSc. Printout of t h e D A T ES O F R E C ENT

MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE

screen:

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
YIN?

ESC = Cancel

Press the Y key. The Maintenance menu displays.

Press the ↑ key to Return to Previous The User Maintenance menu appears.
Menu, then confirm with the ↵ key.

Return to the Main Menu:

Press t h e ↑ k e y t o Return to the Same results as described in chapter 2.1.

Previous menu, then confirm with the of the STA Compact ® Operator’s Manual.
↵ key.

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.5.4. Main Fuses

☞ * ⇒ Catalog number modification.

• Cat. No.: 0301221 (packet of ten fuses rated at 4 A for the 210V/230V instrument).
• Cat. No.: 0301241* (packet of ten fuses rated at 8 A for the 95V/115V instrument).

Caution! This operation must be done with the instrument switched off.

Main
Fuses

Fig. 11 - Replacement of Main Fuses

The main fuses are in two fuse holders, near the ON/OFF switch on the left hand panel of the
STA Compact ® (see figure 11).
– Switch off the STA Compact ® (the green indicator switched off);
– Insert a screwdriver into the slot of the fuse holder. Unscrew fully the fuse holder (in
direction shown by the arrow, counterclockwise); the fuse holder will come free;
– Remove and replace each fuse with another of the same rating (be carefull to Catalog
Numbers, see above);
– Reinstall each fuse holder by screwing it fully home (reverse arrow direction, clockwise);
– Switch ON the STA Compact ® (green indicator switched on).

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Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.5.5. Secondary Fuses

☞ *
⇒ Catalog number modification.

Cat. No. Packet of ten fuses

0301217 0.3 A
27579 1 A
0301221 4 A
27575 6.25 A
0301241* 8 A
0301178* 10 A

Caution! The instrument must be switched off for this operation.

The secondary fuses are on the left panel of the STA Compact ® (see Fig. 12).
– Switch off the STA Compact ®;
– Insert a screwdriver into the slot of the fuseholder containing the fuse to be replaced;
– Press fully home and rotate in the direction shown by the arrow (counterclockwise): the
fuseholder will come free.
– Remove and replace the fuse with another of the same rating (be carefull to Catalog
Numbers, see above).
– Reinstall the fuseholder by turning in the reverse direction (clockwise).
– Switch ON the STA Compact ®.

Fig. 12 - Secondary Fuses

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.6. Decontamination Procedure

Reminder:In accordance with the recommendations of the French Federation of Laboratory

Reagent Manufacturers (SFRL) as well as those provided in the OSHA Act (in the
USA) in regard to persons working in contact with biological substances that may
be hazardous, Diagnostica Stago requests you to ensure that the STA Compact ®
is decontaminated prior to any service intervention; otherwise, observe all applicable
legal regulation if available.

The decontamination procedure consists of the following:

– Cleaning the sample and product drawers and the measurement plate: see chapter
9.2.3. and 9.2.4. of the STA Compact ® Operator’s Manual.
– Cleaning washing wells: see chapter 9.2.2. of the STA Compact ® Operator’s Manual.

V 1.0 - February 01 9 - 37
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7. Maintenance Utility

This Maintenance Utility will help the operator to maintain the instrument in good operating
condition.
After each replacement, a test is performed automatically.
If a problem occurs, this program allows to diagnose as well as possible the problem or the
defect.
The organization of the Maintenance utility is described in the flowchart below (Fig. 13)

Fig. 13 - Organisation of the Maintenance Utility

9 - 38 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.1. How to Access the User Maintenance Menu

There are three ways to access this menu:

• START: TEST PANEL screen displayed.

ACTIONS RESULTS

Press the Esc key. The Main Menu appears:

Status - Loading (...) - Halt

with the cursor on Status.

Press the M key: Maintenance. The following window appears:

Initializing
Please wait ...

The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

• START: Switch ON the STA Compact ®.

ACTIONS RESULTS

Switch ON the STA Compact ®. The following window and message

appear:

STA Compact SYSTEM

Press Delete to access the Maintenance

menu.

Press the Delete key to access the User The following window appears:
Maintenance menu.
Initializing
Please wait ...

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Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

• START: Error message displayed.

ACTIONS RESULTS

Press the Alt + F10 keys simultaneously. The following window appears:

Initializing
Please wait ...

The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Datas Update
Return to Previous Menu

with the cursor on Rinsing Pump.

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.2. Rinsing Pump

This program enables checking the functioning of:

– the liquid level detection for the 3 needles;
– the “Valcor” pump.

9.7.2.1. How to Access the Rinsing Pump Menu

START: User Maintenance displayed.

ACTIONS RESULTS

Press the ↵ key Rinsing Pump. Home positions.

The Rinsing Pump menu appears:

Rinsing Needle No.1

Rinsing Needle No.2
Rinsing Needle No.3
Return to Previous Menu

with cursor on Rinsing Needle No.1.

9.7.2.2. Rinsing Needle No.1, No.2, No.3

START: Rinsing Pump menu displayed.

ACTIONS RESULTS

Press the ↵ key Rinsing Needle No.1. The following window appears :

Or press the ↓ key Rinsing Needle No.2

then confirm with the ↵ key.

Or press the ↓ key Rinsing Needle No.3 VOLUME PUMP TEST

then confirm with the ↵ key.
INFORMATIONS
VIAL POSITION

Needle used : 1
Vial Position :
Pulse Number :
Pump Volume :

Drawer No.2 will open.

Press a key
to continue

1: Needle Number

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Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press any key to continue. Product drawer is opening.

A new message is displayed at the foot

of the preceding window:

VOLUME PUMP TEST

INFORMATIONS
VIAL POSITION

Needle used : 1
Vial Position :
Pulse Number :
Pump Volume :

Place a vial in Drawer No.2

Place a vial (DIN 14, DIN 18 or DIN 22) The vial position is displayed.
in a position corresponding to its
diameter. A confirmation message appears at the
foot of the window:

VOLUME PUMP TEST

INFORMATIONS
VIAL POSITION

Needle used : 1
Vial Position : 33
Pulse Number :
Pump Volume :

Validate the position

Esc: Quit F10: Validate

Check the vial position then press the A message requesting the closing of the
F10 key to confirm. drawer appears at the foot of the screen:

VOLUME PUMP TEST

INFORMATIONS
VIAL POSITION

Needle used : 1
Vial Position : 33
Pulse Number :
Pump Volume :

Drawer No.2 will close.

Press a key
to continue

9 - 42 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press any key to continue. Product drawer is closing.

Test in progress.

The pulse number decrements to reach 0.

GOOD appears near Pump Volume in the

window:

VOLUME PUMP TEST

INFORMATIONS

Needle used : 1
Vial Position : 33
Pulse Number : 0
Pump Volume : GOOD

Press a key
to continue

Call your local authorized Service

Representative, if GOOD does not appear
in the window.

Press any key. Home position in progress.

Back to Rinsing Pump menu.

9.7.2.3. Quit the Rinsing Pump Menu

START: Rinsing Pump menu displayed

ACTIONS RESULTS

Press the ↑ key to reach Return to The User Maintenance menu appears.
Previous Menu, then confirm with the ↵
key.

9.7.3. Bar Code Test

This program checks for accurate reading of bar codes.

This program can be used after the bar code reader set up (see you local authorized Service
Representative for this operation) to define the characters which have to be deleted by the bar
code reader during the reading (the characters which have not to be read are defined in the
Global Options menu, section Bar Code Reading, see section 8.2.2.4. of the STA Compact ®
Operator’s Manual).
Deletion of characters is performed while using Sample Loading menu but not in this menu.

☞ Caution! To avoid Bar Code reading errors, the number of codes which can be read has to
be limited to 2:
– the code used by Diagnostica stago;
– the code used by the laboratory.

V 1.0 -January 96 9 - 43
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.3.1. How to Access the Bar Code Test Menu

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Bar Code Test, The BAR CODE READER screen appears (see
then confirm with the ↵ key. Fig. 14 below).

Fig. 14 - BAR CODE READER Screen

➊ Results of bar code readings.

A cross appears in the box “STA Codes” when bar codes from Diagnostica Stago are used.
➋ List of possible codes.
➌ Enable: Bar Code Reader is set to read the code.
Disable: Bar Code Reader is not set to read the code.

9.7.3.2. To Test the Bar Code Reader

START: BAR CODE READER screen displayed.

ACTIONS RESULTS

Take a vial of STA ® product and identify When the vial is identified:
it with the bar code reader. * audible beep;
* display of the product identification
and name;
* display of a cross in the box “STA
Codes”.

Take a label used in the laboratory. When the label is detected:

* audible beep;
* display of the identify value.

If the label is not detected:

* code not set;
* call your local authorized Service
Representative

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.3.3. Quit the Bar Code Test Menu

START: BAR CODE READER screen displayed, bar code reader waiting for a test.

ACTIONS RESULTS

Press the Esc key to return to the User The following window appears:
Maintenance menu.
Do you want to return to the
previous menu
Y/N ?
Esc = Cancel

Press the Y key. The User Maintenance menu appears.

9.7.4. Printer

This program allows to check:

– The printer connection;
– The printout of the text or graphics.
For the printer maintenance: replacement of the toner cartridge or ribbon, refer to the printer
manual.

9.7.4.1. How to Access the Printer Menu

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Printer, then The Printer menu is displayed:
confirm with the ↵ key.
Connection Checking
Test of the Characters
Graphics
Return to Previous Menu

with the cursor on Connection Checking.

9.7.4.2. Connection Checking

START: Printer menu displayed.

ACTIONS RESULTS

Press the ↵ key Connection Checking. Two messages are possible:

- Printer connected
- No answer from printer

The Printer menu appears.

Connect the printer if necessary and rerun

this test.

If Printer problems persist, call your local authorized Service Representative.

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Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.4.3. Test of the Characters

START: Printer menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Test of the The PRINTER CHARACTER SET TEST screen
Characters, then confirm with the ↵ key. appears (see figure 15 below).

Fig. 15 - PRINTER CHARACTER SET TEST Screen

ACTIONS RESULTS

Press simultaneously the Control + I keys A window displays indicating that the
to print out this screen. printer is connected.

The whole displayed screen prints out.

Check the printout. Two cases are possible:

* There is a good printout
* If problems on the printout occur, the
user should:
- check printer configuration (switches)
by means of chapter 9.7.4.6. of the
STA Compact ® Operator’s Manual.
- check printer itself (paper, ribbon
tape, cleanliness).

Press the Esc key to return to the Printer The Printer menu appears.
menu.

9.7.4.4. Graphics

START: Printer menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Graphics, then The GRAPHICS screen appears (see figure
confirm with the ↵ key. 16 below).

9 - 46 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

Fig. 16 - GRAPHICS Screen

ACTIONS RESULTS

Press simultaneously the Control + I keys A window appears indicating that the
to print out this screen. printer is connected.

The whole displayed screen prints out.

Check the printout. Two cases are possible:

*There is a good printout;
*If problems on the printout occur, the
user should:
- check printer configuration (switches)
by means of chapter 9.7.4.6.;
- check printer itself (paper, ribbon
tape, cleanliness).

Press the Esc key to return to the Printer The Printer menu appears.
menu.

9.7.4.5. Quit the Printer Menu

START: Printer menu displayed.

ACTIONS RESULTS

Press the Esc key. The following window displays:

Do you want to return to the

previous menu
Y/N ?
Esc = Cancel

Press the Y key. The User Maintenance menu appears.

V 1.0 -January 96 9 - 47
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.4.6. Printer Configuration

For an IBM or EPSON generic printer, see printer manual and observe the following
recommendations.

PARAMETER CHOICE REMARKS

Emulation Mode IBM Proprinter Primordial, any other choice will lead to
X24E unpredictable results in graphic mode.

Character Set Code Page 437 Primordial for all semi-graphic characters
(table printout).

Interface Type Parallel STA Compact ® cannot control printout

through serial mode.

Image Density H i g h D e n s it y If applicable.

(≥300dpi)

Auto Line Feed NO NO automatic line feed after a carriage

return.

Form Length 11 or 12 inches According to paper format.

Line Spacing 6 lines per inch If applicable.

Print Quality Normal mode If applicable, to speed up the printout.

Skip-Over NO If applicable.
Perforation

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.5. Saving

This program allows to save or to load the following parameters:

SAVING LOADING

Test After each modification in the Test According to the local authorized
Configuration Setup or in the Global Options. Service Representative.

After each modification of the According to the local authorized

System system parameters or after each Service Representative.
Parameters
Service call.

Error Only for Service Representative. Only for Service Representative.

Messages

☞ Caution! Before saving, format the diskette with the STA Compact ® (see below, chapter
9.7.5.5. of the STA Compact ® Operator’s Manual).
To avoid computer viruses, do not use the saving diskette on any other PC system.
The loading of the parameters has to be made by the local authorized Service
Representative.

9.7.5.1. How to Access Saving Menu

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Saving, then The SAVE/REREAD THE PARAMETERS screen
confirm with the ↵ key. appears (see figure 17 below) with the
cursor on Selection of Items.

Fig. 17 - SAVE/REREAD THE PARAMETERS Screen

V 1.0 -January 96 9 - 49
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.5.2. Selection of Items

START: SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

Press the ↵ key to select the items. T h e c u r s o r g o es to the Test

Configurations area.

A help window for selection appears at the

left bottom of the screen.

The following items can be selected:

* Test Configuration;
* System Parameters;
* Error Messages.

Select the items: Selection of Items done.

* Press the ↑ or ↓ keys to move the

cursor;

* Press the Space Bar key to select/

unselect an item;

* Press the F8 key to select/unselect all

the items;

* Press the Esc key to cancel the

selection.

Press the F10 key to confirm the selection Selection of Items validated

9.7.5.3. Load

Prior: Select the items which have to be loaded (see chapter 9.7.5.2. of the STA Compact®
Operator’s Manual).

☞ Caution! Do not load the error messages. Check that this item is not selected by mistake : this
is an option for your local authorized Service Representative.
START: SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

Press the ↓ key to Load then confirm with The following windows will be displayed
the ↵ key. according to the selected parameters:

Do you want to re-read

selected parameters ?
Return: Valid - Esc : Cancel

Caution: This operation

will erase set up
on the STA Compact
Return: Valid - Esc : Cancel

9 - 50 V 1.0 -January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Press the ↵ key to confirm. The following window appears:

SAVING/LOADING PARAMETERS

Please insert load diskette

in the drive.
Return: Valid - Esc : Cancel

Caution! This procedure deletes current data of the selected files (Test Configuration,
System Parameters or Error Messages).

Insert the required diskette into the floppy The following windows appear during the
drive then confirm with the ↵ key. loading:

Diskette Control in Progress

Please wait

Loading
Please wait

Advance %
       

Loading OK

Then, the SAVE/REREAD THE PARAMETERS

screen appears at the end of the loading.

9.7.5.4. Save

☞ Prior: Select the items which have to be saved (see section 9.7.5.2. of the STA Compact ®
Operator’s Manual).

START: SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

Press the ↓ key to reach Save, then The following window appears:
confirm with the ↵ key.
SAVING/LOADING PARAMETERS

Do you want to save

selected parameters ?
Return : Valid - Esc : Cancel

Press the ↵ key to confirm. The following window displays:

Please insert save diskette

in the drive.
Return : Valid - Esc : Cancel

V 1.0 - January 96 9 - 51
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Insert a 3 1/2", 1.44 Mo diskette into the The following window appears:
floppy drive, then confirm with the ↵ key.
Diskette Control in Progress
Please wait

If all items have been selected, the

following window is displayed:

Valid to start diskette format;

Caution! This operation will

erase all data on the diskette

If all items have been selected, press the The following windows appear during
↵ key. formatting (if all items have been selected):

Format in progress
Please wait

Advance %
       

The following windows appear in any case:

Saving
Please wait

Advance %
       

Saving OK

Then, the SAVE/REREAD THE PARAMATERS

s c r e e n a p p e a r s a t t he e n d o f t he
Parameters Saving.

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STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.5.5. Format a diskette

☞ Caution! Erase all data (all files) of the diskette. This operation enables to re-use a diskette
with full capacity.
START: SAVE/REREAD THE PARAMATERS screen displayed.

ACTIONS RESULTS

Press t h e ↓ key to reach Format a A warning indication appears in the

Diskette, then confirm with the ↵ key. displayed window:

SAVING/LOADING PARAMETERS

Please insert in the drive

the diskette to format

Caution: this operation

will erase all data
on the diskette !
Return: Valid - Esc : Cancel

Insert a 3 1/2", 1.44 Mo diskette into the The following windows appear while
floppy drive, then confirm with the ↵ key. formatting:

Format in progress
Please wait

Advance %
       

Then, the SAVE/REREAD THE PARAMETERS

screen appears at the end of the formatting.

9.7.5.6. Quit the Saving Menu

START: SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

Press t h e ↓ key to reach Return to The following window displays:

Previous Menu, then confirm with the ↵
key. Updating files
Please wait...

The User Maintenance menu appears.

9.7.6. Maintenance

This program helps the operator to the replace:

– the Needles,
– the SyringeTip and/or the Syringe;
– the Suction Tip;
– the Halogen Lamp of the optical module.

It enables also to facilitate some maintenance procedures and to have access to a history of
the recent maintenances.

V 1.0 - January 96 9 - 53
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.6.1. How to Access the Maintenance Menu

START: Maintenance menu displayed

ACTIONS RESULTS

Press the ↓ key to reach Maintenance, The following window displays:

then confirm with the ↵ key.
Initialization in progress
Please wait...

The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu

with the cursor on Needle Purge.

9.7.6.2. Needle Purge

This program allows to purge the hydraulic circuit to exclude bubbles from tubings.

A. How to Access the Needle Purge Menu

START: Maintenance menu displayed.

ACTIONS RESULTS

Press the ↵ key Needle Purge. The NEEDLE PURGE screen appears.

The following windows appear:

Checks in progress
Please wait...

Home position in progress

Please wait...

Positioning in well
Please wait...

9 - 54 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

Fig. 18 - NEEDLE PURGE Screen

B. Needle Purge

☞ Caution! In case of problem during the purge, press the Alt + F10 keys simultaneously, then
call your local authorized Service Representative.
START: NEEDLE PURGE screen displayed.

ACTIONS RESULTS

Press the F1 key. Purge of Needle No.1.

Press the F2 key. Purge of Needle No.2.

Press the F3 key. Purge of Needle No.3.

C. Quit the Needle Purge Menu

START: NEEDLE PURGE screen displayed.

ACTIONS RESULTS

Press the Esc key. The following window displays:

Do you want to return to the

previous menu
Y/N ?
Esc = Cancel

Press the Y key. Home positions.

The Maintenance menu appears.

9.7.6.3. Needle Replacement

See description in Replacing Components chapter, section 9.5.1. of the STA Compact ®
Operator’s Manual.

V 1.0 - January 96 9 - 55
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.6.4. Syringe Tip/Syringe Replacement

See description in Monthly User Preventive Maintenance chapter, section 9.3. of the STA
Compact ® Operator’s manual.

9.7.6.5. Suction Tip Replacement

START: Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Suction Tip The following window displays:
Replacement, then confirm with the ↵ key.
Initializing...

The Suction Tip Replacement menu

appears:

Suction Tip Replacement

Suction Tip Test
Return to Previous Menu

with the cursor on Suction Tip

Replacement.

A. Suction Tip Replacement

See description in the Replacing Components chapter, section 9.5.2. of the STA Compact ®
Operator’s Manual.

B. Suction Tip Test

START: Suction Tip Replacement menu displayed.

ACTIONS RESULTS

Press the ↓ key to Suction Tip Test then The following window appears:
confirm with the ↵ key.
Home position in progress

Test of the suction tip on the measurement

plate.

The following window appears:

SUCTION TIP REPLACEMENT

The procedure was

successful :
Detection has succeeded
Space Bar to proceed ...

Press the Space Bar to proceed T he Suction Tip Replacement menu

appears

9 - 56 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.6.6. Halogen Lamp Replacement

START: Maintenance menu displayed

ACTIONS RESULTS

Press the ↓ key to reach Halogen Lamp The following window displays:
Replacement, then confirm with the ↵ key.
Initializing

The Halogen Lamp Replacement menu

appears:

Lamp Replacement
Lamp Test
Return to Previous Menu

with the cursor on Lamp Replacement.

A. Lamp Replacement

See description, in the Replacing Components chapter, section 9.5.3. of the STA Compact ®
Operator’s Manual.

B. Lamp Test

START: Halogen Lamp Replacement menu displayed.

ACTIONS RESULTS

Press t h e ↓ key to Lamp Test, then Halogen lamp test in process.

confirm with the ↵ key.
At the end of this test, the following window
appears:

LAMP REPLACEMENT

The procedure was

successful
Space Bar to proceed ...

Press the Space Bar to proceed. The Halogen Lamp Replacement menu
appears.

C. Return to Maintenance Menu

START: Halogen Lamp Replacement menu displayed.

ACTIONS RESULT

Press t h e ↓ key to reach Return to The Maintenance menu appears.

Previous Menu, then confirm with the ↵
key.

V 1.0 -January 96 9 - 57
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.6.7. Dates of Recent Maintenance

This screens groups the dates and times of the recent maintenances for several parts of the
STA Compact ®;
– Rinsing of needles No.1, No.2, No.3;
– Replacement of needles No.1, No.2, No.3;
– Replacement of the syringe (Teflon tip);
– Replacement of suction tip;
– Replacement of halogen lamp.
After each replacement or maintenance procedure, it is recommended to print this screen in
order to keep it in the maintenance log books used by the laboratory.
START: Maintenance menu displayed

ACTIONS RESULTS

Press the ↓ key to reach Dates of Recent The DATES OF RECENT MAINTENANCE screen
Maintenance then confirm with the ↵ key. appears.

Press the keys Alt and Prtsc. P r i n t o u t o f th e D A T E S O F R E C E N T

MAINTENANCE screen.

Press the Esc key. The following window displays:

Do you want to return to the

previous menu
Y/N ?

Esc = Cancel

Press the Y key. Home positions.

The Maintenance menu appears.

Fig. 19 - DATES OF RECENT MAINTENANCE Screen

9 - 58 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.6.8. Quit the Maintenance Menu

START: Maintenance menu displayed

ACTIONS RESULTS

Press t h e ↓ key to reach Return to Return to the User Maintenance menu.

Previous Menu, then confirm with the ↵
key.

9.7.7. Photometry Graphics

This program allows to display/print very precise information used:

– In case of error on the colorimetry/immunology results to help the Service Representative to
solve the problem;
– To define new methodologies for the colorimetry or immunology tests.

9.7.7.1. How to Access the Photometry Graphics Menu

START: User Maintenance menu displayed

ACTIONS RESULTS

Press the ↓ key to reach Photometry The list of the last 99 files appears.
Graphics, then confirm with the ↵ key.
The following keys are available:
↵ View
↑,↓ Scroll
Esc Quit
Home Beginning of List
End End of List

Select the required file with the ↑ or ↓ keys, The required graphics appears (see figure
then confirm with the ↵ key. 21 below for example)

The following keys are available:

F2 Delete point
F3 STA Calculus
F4 Position the cursor on the points or on
the curve
F5 Change scale: zoom or normal
F6 Print graphics
F7 Print measurement values
F8 Modify window
F10 Other patient

V 1.0 - January 96 9 - 59
Maintenance STA COMPACT ® OPERATOR'S MANUAL

Fig. 20 - Colorimetry Graphics (Example)

➊ Available functions:

F2 In OD/Minute kinetic mode allows to eliminate (or reachieve) a point for regression
calculation.

F3 In OD/Minute kinetic mode allows:

F3 STA - to display in yellow the points used by the STA Compact ® for regression
Calculus calculation (the other ones will be displayed in red);

F3 Full - to display all the points recorded by the STA Compact ® during the test;
Calculus

☞ If no result has been given by the STA Compact ®, no regression curve will be displayed ; in
the area ➐ the regression coefficient will go to zero:

R = 0.000

F4 To select moving cursor on Measurement points or on regression curve.

F5 Displays the graphics between the min. and max. measurements (zoom) or between
OD min. and OD max. (normal scale).

F6 Print screen (print curve).

F7 Print list of measurement values.

The pair of points [Time(sec); Optical Density (OD)] displayed in bold are those used
by the STA Compact ® for the regression calculation.

F8 To change limits of the window calculation.

F10 To load another measurement file.

9 - 60 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

← → Move the cursor.

+- Modify step of cursor moving.

➋ Name of the screen: Colorimetry Graphics or Immunology Graphics, depending on the test.

➌ Date and Time of the results saving, name of the file, and channel used for measurement.

➍ Abbreviation of the test, type of method (OD/minute kinetics or kinetic 2 points), and file
Identification.

➎ Measurement points and regression curve:

* Point displayed in yellow: point used for the regression calculation.

* Point displayed in red: point not used for the regression calculation.
➏ Reject criteria:

Kinetic OD/Minute:

OD min. = 0 recall of the linearity range of

OD max. = 2.5 the measurement system
R = Regression coefficient for the selected test as defined in the TEST SETUP screens.
Slope = default value (-0.100) allows to control that kinetic curves are with positive
slopes.

Kinetic 2 points:

OD min = 0 recall of the linearity zone of the

OD max = 2.5 measurement system

➐ Characteristics of the curves:

OD = a + b times Time
OD = equation of the regression curve
a = offset
b = slope
R = regression coefficient

The equation of the regression curve (OD) and the regression coefficient (R) are calculated
with the yellow points which have been included in the window calculation. These values are
updated at every addition/retrieval of one point in the window calculation or after using the F3
key.

Kinetic 2 pts:
∆ OD = OD (T1) - OD (T0)
T0 = Initial Time
T1 = Final Time

OD (T1) = Optical density at the time T1 moment

OD (T0) = Optical density at the time T0 moment

The difference of the optical density (∆OD) is calculated with the points OD (T1) and OD (T0).
The calculation is updated if the limits of the window calculation are modified.
➑ Displays of the OD and the Time according to the cursor position.

➒ Window calculation.

V 1.0 - January 96 9 - 61
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.7.2. To Eliminate Points

START: Required Graphics displayed.

ACTIONS RESULTS

Press the → key to reach the point which The required point is eliminated out of the
has to be eliminated, then press the F2 key regression calculation.
to confirm the choice.

The new regression curve appears.

Repeat the operation if necessary.

9.7.7.3. STA Compact ® Calculation

START: Required Graphics displayed (F3 STA Calculus displayed).

ACTIONS RESULTS

Press the F3 key. All points used by the STA Compact ® for
the regression calculation (patient result)
appear in yellow on the screen, points not
used are displayed in red.

The regression curve appears.

9.7.7.4. Print the Curve

START: Required Graphics displayed.

ACTIONS RESULTS

Press the F6 key. The Photometry Graphics prints out.

9.7.7.5. Print List of Measurement Values

START: Required Graphics displayed.

ACTIONS RESULTS

Press the F7 key. The list of raw data for the required files
prints out.

The pair of points [Time (sec); Optical

Density (OD)] displayed in bold are those
used by the STA Compact ® for the
regression calculation (patient result).

9 - 62 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.7.6. Change Limits of the Window Calculation

START: Required Graphics displayed

ACTIONS RESULTS

Press the F8 key. The following window displays: P10

File Name : COLMES XX.DAT

Initial Time : XX (seconds)
Final Time : XX (seconds)

XX: number of the calculation file.

Change the final/initial time with the The calculation window and the regression
numerical pad, then confirm with the ↵ curve are updated.
key.

Press t h e F10 k e y to v a lid a t e the

modifications.

9.7.7.7. Load Another Measurement File

START: Required Graphics displayed

ACTIONS RESULTS

Press the F10 key. The list of the last 99 measurement files
appears.

Press the ↓ key to reach the required file The selected Photometry Graphics
in the list, then confirm with the ↵ key. appears.

9.7.7.8. Quit the Photometry Graphics Menu

START: Required Graphics displayed

ACTIONS RESULTS

Press the Esc key. The following window displays:

Do you want to return

to the previous menu
Y/N ?
Esc = Cancel

Press the Y key. The User Maintenance menu appears.

V 1.0 - January 96 9 - 63
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.8. Error History

This program examines the different error messages which have been displayed during the STA
Compact ® functioning.

9.7.8.1. How to access the Error History Menu

START: User Maintenance menu displayed

ACTIONS RESULTS

Press the ↓ key to reach Error History, The ERROR HISTORY screen appears (see
then confirm with the ↵ key. figure 21 below).

Fig. 21 - ERROR HISTORY Screen

9 - 64 V 1.0 - January 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.8.2. Parameter Selection

START: ERROR HISTORY screen displayed

ACTIONS RESULTS

Press the F2 key.# The sort criteria appear:

01: BACKGROUND TASK

02: CUVETTE FEED
03: RACK COMMUNICATION
04: MEASUREMENT BLOCK COMMUNICATION
05: SYSTEM HOST COMMUNICATION
06: MANAGEMENT OF ARM #1
07: MANAGEMENT OF ARM #2
08: START OF TEST
09: AXIS Z COMMUNICATION
10: MEASUREMENT MANAGEMENT
11: SYSTEM BOOT
49: STA COMPACT MAINTENANCE
51: SAMPLE LOADING
52: PRODUCT LOADING
53: LIQUID PRIMING

Enter the selection (2 numbers) then The ERROR HISTORY screen appears.
confirm with the F10 key.

Press the ↓ or ↑ keys to display all the The selected errors are displayed.
selected error messages

9.7.8.3. Quit the Error Message Menu

START: ERROR HISTORY screen displayed.

ACTIONS RESULTS

Press the Esc key. The following message displays:

Do you want to return

to the previous menu
Y/N ?

Esc = Cancel

Press the Y key. Return to the User Maintenance menu.

9.7.9. Host Computer Communications

This program checks for the current communications between the STA Compact ® and the host
computer. It recalls the communication parameters (see description, chapter 8.2.3.2. of the STA
Compact ® Operator’s Manual).

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach Host Computer The COMMUNICATIONS screen appears.
Communications, then confirm with the
↵ key.

V 1.0 - January 96 9 - 65
Maintenance STA COMPACT ® OPERATOR'S MANUAL

ACTIONS RESULTS

Press the F1 key to run the test. The following message appears:

Test
In progress

At the end of this test, the PASSED/FAILED

message appears at the left bottom of the
displayed screen

Check the connection between the STA

Compact ® and the host computer in case
of problems, then rerun these tests.

Press the Esc key to Exit. The following window displays:

Do you want to return

to the previous menu
Y/N ?
Esc = Cancel

Press the Y key. The User Maintenance menu appears.

9.7.10. DATA UPDATE

This program enables to load new data provided by Diagostica Stago: new software release,
introduction of new reagents or new methods,...

☞ Caution! To avoid computer viruses, do not use the diskettes provided by Diagostica Stago
on any other PC System.
Software Update

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↓ key to reach DATA UPDATE, then The following window appears:
confirm with the ↵ key.

DATA UPDATE

Insert Diskette
in Floppy Disk Drive

Esc : Quit F10 : Validate

Insert in the drive diskette #1 from the Transfer of data from diskette to hard disk.
diskettes provided by Diagnostica Stago
then confirm with the F10 key. The following message is displayed:

“Insert the floppy #2 in the floppy disk

Press ↵ to continue (SPACE : SOUND=OFF)”

Audible beep (this beep can be switched off

by means of the Space Bar).

9 - 66 V 1.0 -November 96
STA COMPACT ® OPERATOR'S MANUAL Maintenance

ACTIONS RESULTS

Remove diskette #1 from drive. Transfer of data from diskette to hard disk.

Insert in the drive diskette #2 from the The following message is displayed:
diskettes provided by Diagnostica Stago
then confirm with the ↵ key. “Insert the floppy #3 in the floppy disk
Press ↵ to continue (SPACE : SOUND=OFF)”

Audible beep (this beep can be switched off

by means of the Space Bar).

Repeat these operations of retrieval and When data of all diskettes have been
insertion as many times as requested. transferred to the hard disk, the following
window appears:

Confirmez la modification
des fichiers de données

[↵]= Oui [ Echap] =Non

Press the ↵ key. The following window appears:

INSTALLATION TERMINEE

[ ↵]= Continuer

Press the ↵ key. The following message is displayed:

“Press key to continue”

Press any key. If the last diskette has not been removed
from the drive, the following message
appears:

“Remove the floppy #4 from the floppy

disk . Press ↵ to continue
(SPACE : SOUND=OFF)”

Audible beep (This beep can be switched

off with the Space Bar).

Remove the last diskette from the drive STA Compact ® updates several files and
then confirm with the ↵ key. proceeds with a sequence loading if
necessary.

Then, the following message is displayed.

“Enter the last 4 digits of the serial

number of the STA :”

Look f o r th e s e r ia l n u m b e r o f t h e Reset of the STA Compact ®, see Chapter

instrument on the identification label (left 2.1. of the STA Compact ® Operator’s
side of the instrument, see Chapter 1.6. of Manual.
the STA Compact ® Operator’s Manual),
type the last 4 digits of this number and
confirm with the ↵ key.

V 1.0 -January 96 9 - 67
Maintenance STA COMPACT ® OPERATOR'S MANUAL

9.7.11. Utilities menu

To allow the user to save patients results, associated calibrations and information concerning
the products used.

ACTIONS RESULTS

Press the ↑ key to reach Utilities Menu, The following screen appears:
then confirm with the ↵ key. (See Fig. 22)

Fig. 22 - TDEX Utilities Screen

ACTIONS RESULTS

Enter the name of the file (8 caracters Creating a file “xxxxxxxx.txt” which can be
max.) then press the ↵ key. used in other applications.

Enter your comments, if necessary. It is

possible to enter 5 lines of comments which
can include up to 75 characters each.

Press the ↵ key.

Insert the diskette in the reader.

Press the F10 key to transfer the data. The following windows displays:

Transfer in Progress...

Transfer of data from the diskette to hard

disk

The following windows displays:

Do you want to return to the previous

menu
Y/N
Esc = Cancel

Press the Y key

9 - 68 V 1.0 - February 01
STA COMPACT ® OPERATOR'S MANUAL Maintenance

9.7.12. Return to the Main Menu

START: User Maintenance menu displayed.

ACTIONS RESULTS

Press the ↑ key to Return to the Previous Same results as described in chapter 2.1 of
Menu, then confirm with the ↵ key. the STA Compact ® Operator’s Manual.

V 1.0 -February 01 9 - 69
STA COMPACT ® OPERATOR'S MANUAL Table of Contents, Chapter 10

10. TROUBLESHOOTING 1

10.1. Messages Displayed 1

10.1.1. Error Messages Coded in the Form of a Window 1
10.1.2. Error Messages in the Form of Text or Window 6

10.2. Messages Relating to the Cuvettes 7

10.3. Problems with Results 9

10.3.1. List of Points to Be Checked 9
10.3.2. Typical Problems with Results 9

10.4. Problems Related to the Test Execution 11

10.5. Other Problems Found 12

10.5.1. Power-on Problems 12
10.5.2. Dirty Liquid Filters 12

V 1.0 - January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

10. TROUBLESHOOTING
10.1 Messages Displayed
Most possible errors are coded and displayed as a message in a window on the screen. Other
errors appear in text form and may be anywhere on the screen.
☞ Messages in window form: If there’s only the “Press Alt + F10” option, wait for the end of the
tests, otherwise the tests will be rerun. Indeed, Alt + F10 means whether access to the
Maintenance Menu or stop of the STA.

10.1.1 Error Messages Coded in the Form of a Window

Description:

Management of Arm #2 } type of problem

Error 07.30.30 } error number
Removal
. 
 cause of error
.

Missing Cuvette
.
Esc = continue } solution

Procedure when error messages appear in the form of a window:

Error messages for which the cause is clearly described are not detailled below.
®
Note : The procedure to switch the STA Compact off is described in chapter 2.6 of this
manual.
For the others error messages, procedure to follow:

Error Number Item(s) Concerned Procedure

Beginning By:
®
! 01 ! Washing Solution ! Replace the bottle of STA - Cleaner
Solution, see chapter 2.5. of this manual;
! If the problem persists, call your local
authorized Service Representative.
! 01 ! Vacuum Reservoir ! Proceed with the cleaning of the washing
wells, see chapter 9.2.2. of this manual;
! If the problem persists, call your local
authorized Service Representative.
! 01 ! Incubation ! Check the Peltier reservoir, see
Temperature out of chapter 9.2.5. of this manual;
Limit
! If the problem persists, call your local
authorized Service Representative.
! 01 ! Cleaner ! Check that the closing of the switch
SolutionReservoir detecting the presence of the bottle is
Check presence heard when it is replaced, see chapter
2.5. of this manual;
! If the problem persists, call your local
authorized Service Representative

V 1.0 – January 96 10 - 1
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

Error Number Item(s) Concerned Procedure

Beginning By:
! 01 ! Used Liquid ! Check that the closing of the switch
Container Check detecting the presence of the bottle is
presence heard when it is replaced, see chapter
2.5. of this manual;
! If the problem persists, call your local
authorized Service Representative
! 01 ! Used LiquidContainer ! Check the liquid level in the bottle of
Check used liquid, replace if necessary, see
maximumallowed chapter 2.5. of this manual;
volume
! If the problem persists, call your local
authorized Service Representative.
! 01 ! Cuvette ! Check that the cuvette disposal drawer
DisposalDrawer is pushed fully home;
Check presence
! if the problem persists, call your local
authorized Service Representative.
! 02 ! Cuvette Missing ! Replace the roll of cuvettes, see chapter
2.3. of this manual;
! If the problem persists, call your local
authorized Service Representative.
! 02 ! Loading Station ! See chapter 10.2. of this manual;
Measuring Station
Shuttle missin
! 03 ! Rack Communication ! Follow the instructions:
* Press the Esc key;
* Or Press simultaneously the ALT +
F10 keys;
®
* Switch the STA Compact off;
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.
! 04 ! Measurement Block ! Follow the instructions:
Communication
* Press the Esc key;
* Or Press simultaneously the ALT + F10
keys;
®
* Switch the STA Compact off;
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.

10 - 2 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

Error Number Item(s) Concerned Procedure

Beginning By:
! 05 ! System Host ! Follow the instructions:
Communication
* Press the Esc key;
* If an identification number is not
recognized by the central site, check the
identification numbers on the STA
®
Compact and the central site;
* In case of file error, restart the
®
transmissions from the STA Compact ;
see chapter 6.4. of this manual.
! 06 Management of Arm #1: ! Follow the instructions, depending on the
error messages:
* Movement P
X * Press the Esc Key;
Y
Z1 * Or press the ALT + F10 keys;
Z2 ®
Z3 * Switch off the STA Compact ;

Impossible movements Move manually the related axis of the

pipetting head: X (left-right movement),
* Uncompleted Y (front-rear movement), Z1 (needle #1
movement up-down), Z2 (needle #2 up-down), Z3
(needle #3 up-down);
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.
! 06 ! Management of Arm ! Follow the instructions, depending on the
#1 (Pipetting Head). error messages:
The needle must be *Press the Esc Key;
bended
*Or press the ALT + F10 keys;
Check the needle No.x ®
* Switch the STA Compact off;
* Switch it on again;
! If the problem persists, call your local
authorized Service Representative.
! 06 ! Management of Arm ! Follow the instructions:
#1 (Pipetting Head)
* Press the Esc key;
No. Level Detection
* Check the liquid level in the vial or
in the tube of plasma;
* Replace if necessary the vial or the tube
of plasma
* Inhibit liquid level detection (see chapter
8.1.2.4. of this manual).
! If the problem persists, call your local
authorized Service Representative

V 1.0 – January 96 10 - 3
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

Error Number Item(s) Concerned Procedure

Beginning By:
! 07 ! Management of Arm ! Follow the instructions, depending on the
#2 (Suction Head) error messages:
* Movement Y * Press the Esc Key;
Z
* Or press the ALT + F10 keys;
* Impossible ®
movements * Switch the STA Compact off;

* Uncompleted * Move manually the related axis on the

movements suction head: Y (front-rear movement), Z
(up-down);
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.
! 07 ! Management Arm #2 ! Follow the instructions, depending on the
(Suction Head). error messages:
The suction vacuum is * Press the Esc Key;
not operating correctly.
* Or press the ALT + F10 keys;
* Proceed with the suction tip cleaning
(see chapter 9.2.6. of this manual) or if
necessary with the replacement of the
suction tip (see chapter 9.5.2. of this
manual);
! If the problem persists, call your local
authorized Service Representative.
! 07 ! Management of Arm ! See chapter 10.2. of this manual.
#2 (Suction Head)
Cuvette Missing
! 08 ! Start of test Problem ! Follow the instructions:
reading file
* Press simultaneously the ALT + F10
Test.dat keys;
®
Calib.dat * Switch the STA Compact off;
Cq.dat * Switch it on again;
! If the problem persists, call your local
authorized Service Representative
! 08 ! Start of Test Products ! Follow the instructions:
Missing
* Press the Esc key;
* Load the missing poducts

10 - 4 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

Error Number Item(s) Concerned Procedure

Beginning By:
! 09 ! Axis Z ! Follow the instructions:
Commmunication
* Press the Esc key;
* Or Press simultaneously the ALT + F10
keys;
®
* Switch the STA Compact off;
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.
! 10 ! Measurement ! Follow the instructions:
Management
* Press the Esc key;
* Incorrect channel
reception * Or Press simultaneously the ALT + F10
keys;
* Motor too slow ®
* Switch the STA Compact off;
* Incorrect conversion ®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative
! 10 ! Measurement ! Follow the instructions:
Management
11 * Press the Esc key;
! System Boot
* Run the lamp test of the User
*Optical module lamp Maintenance menu, see chapter
does not work 9.7.6.6. of this manual;
* Optical module lamp, * Replace the lamp, see chapter 9.5.3. of
level is too low this manual.
! If the problem persists, call your local
authorized Service Representative
! 10 ! Measurement ! Follow the instructions:
Management
11 * Press the Esc key;
! System Boot
* Clean or replace if necessary the air filter
Optical of the optical module (see respectively
moduletemperature is chapters 9.2.1. and 9.4. of this manual.
too high
! If the problem persists, call your local
authorized Service Representative.
! 11 ! System Boot ! Follow the instructions:
*Software versions * Press the Esc key;
*RAM/ROM state * Or Press simultaneously the ALT + F10
keys;
*Chronometry
®
Calibration * Switch the STA Compact off;
®
*Chromogenic * Switch the STA Compact on again;
Calibration ! If the problem persists, call your local
authorized Service Representative.

V 1.0 – January 96 10 - 5
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

Error Number Item(s) Concerned Procedure

Beginning By:
! 49 STA COMPACT ! Follow the instructions:
MAINTENANCE
* Press the Esc key;
* Or Press simultaneously the ALT + F10
key;
®
* Switch the STA Compact off;
®
* Switch the STA Compact on again;
! If the problem persists, call your local
authorized Service Representative.
! 51 SAMPLE LOADING ! Follow the instructions:
Sample Drawer * Remove what is blocking the opening (or
the closing) of the drawer;
Jammed
* Press the ↵ key.

! if the problem persists, call your local

authorized Service Representative.
! 52 ! PRODUCT LOADING ! Follow the instructions:
Product Drawer * Remove what is blocking the opening (or
the closing) of the drawer;
Jammed
* Press the ↵ key. if the problem persists,
call your local authorized Service
Representative.
! if the problem persists, call your local
authorized Service Representative

10.1.2. Error Messages in the Form of Text or Window

Type 1: “Run time error ...” appears in a window.

or: “Disk error ...” appears anywhere on the screen.
or: “Fatal error...” appears anywhere on the screen.

Type 2: “HFXX error ...” appears in yellow at the foot of the screen.
“HSXX error...” is displayed in black on a grey background.

Procedure if a type 1 or type 2 message appears:

– write the error number;
– press the Alt and PrtSc key on the keyboard to produce a hard copy of the screen
display;
®
– switch off the STA Compact ;
®
– switch the STA Compact on again;
– if the problem persists, call your local authorized Service Representative and forward the
information obtained from the screen (hard copy).

10 - 6 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

10.2 Messages Relating to the Cuvettes

•Example 1
MANAGEMENT OF ARM #2

Error 07.30.30
-
Removal
Missing cuvette
-
-

Esc = Continue

Press the Esc key to delete the error message.

®
When the STA Compact goes to standby mode (no more measurement in progress), thefollowing
message is displayed :

START OF TEST

Error 08.20.00
CUVETTE ERROR
At least one cuvette is still on
the measuring block
How do you want to remove it?

F1 = Automatic F2 = Manual

Possible functions:
F1: Arm No. 2 (Suction Head) tries again to pick up the cuvette.

Caution! In case of defective suction tip or defective cuvette, this operation is impossible and
may lead to jammed situations.

F2: The operator can remove the transparent panel and manually remove the cuvette which
cannot be automatically picked up (with usual precautions to biohazardous material).

Caution! After this operation, the transparent panel must absolutely be replaced otherwise it
will be impossible to run further analyses.

PROBABLE CAUSE(S) POSSIBLE SOLUTION(S)

! suction tip defective ! Clean the suction tip (see procedure, chapter
®
9.2.6. of the STA Compact Operator’s
Manual)
! Replace it if necessary (see procedure in
®
chapter 9.5.2. of the STA Compact
Operator’s Manual).;
! Cuvette in poor condition: for ! Replace the roll of cuvettes.
example lugs broken

V 1.0 – January 96 10 - 7
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

PROBABLE CAUSE(S) POSSIBLE SOLUTION(S)

! Bead present in a measurement ! Access the User Maintenance menu (see
or incubation well, causing the chapter 9.7.1. of the panel;
cuvette to be wrongly positioned
! Remove the bead.
! Suction head incorrectly ! Call your local authorized Service
positioned on the cuvette Representative.

•Example 2: “Shuttle missing - loading station”

PROBABLE CAUSE(S) POSSIBLE SOLUTION(S)

! Cuvettes jammed in loading ! Press the Esc key;
system ®
! Switch the STA Compact off (see chapter
2.6. of this manual);
! Pull the cuvette roll drawer;
! if the cuvette roll drawer cannot be opened,
®
remove the bottle of STA - Cleaner Solution,
remove the bottle of used liquid, remove the
bottle support in order to access the cuvette
loading system;
! Remove the film roll to the rear (turn in
reverse side of the arrow);
! Remove all the cuvettes from the loading
system, using a fine screwdriver if necessary.
Do not use fingers, risk of injuries by the
pneumatic jack;
! Remove all cuvette debris;
! Replace all items;
®
! Switch the STA Compact on again;
! if the problem persists, call your local
authorized Service Representative.

! Shuttle detection switch faulty. ! Call your local authorized Service

Representative.

10 - 8 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

10.3. Problems with Results

10.1.1. List of Points to Be Checked

If a problem is found in the results, the following points should be checked:

! Check that mechanical and robotic items are operating satisfactorily.

" Check the rinsing volumes: run the function Rinsing Pump of User Maintenance menu (see
®
chapter 9.7.2. of the STA Compact Operator’s Manual).

# Execute a quality control and compare the result with the previous results.

$ Check the samples:

– poor centrifugation;
– insufficient volume;
– presence of clots or micro-clots;
– presence of bubbles, etc.

% Verify the methodology: from the Test Setup menu, see which configuration or test is causing a
problem and compare with the methodologies recommended by Diagnostica Stago.

& Check the reagents:

- reagent or reagents incorrectly reconstituted, etc.,
" In this case, load a new vial of reagent.

' Execute a quality control for a major test and compare the result to the previous results.

( Check the other routine tests run on the same sample.

®
) Check that the temperature of the STA Compact product drawer is between 15 and 19°C:
– place a vial half filled with water in the position No.29,
– wait 30 minutes,
– check the temperature with a mercury thermometer (15°C to 19°C).

* Check that the appropriate weekly and monthly maintenance has been carried out.

10.3.2. Typical Problems with Results

The examples shown below are expressed in clotting time and refer to 3 mixed routine
tests (patient by patient).

PT PTT Fibrinogen ProbableCauses Possible Solutions

(Time) (Time) - (Time)
OK Short or OK ! 1st: ! Check the rinsing of needle No.2
long (see procedure chapter 9.7.2.2. of
Needle No.2 ®
the STA Compact Operator’s
Incorrect pipetting Manual).
! Pass the mandrel through the
needle No. 2 to unblock it (see
procedure in chapter 9.2.2. of the
®
STA Compact Operator’s Manual).

V 1.0 – January 96 10 - 9
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

PT PTT Fibrinogen ProbableCauses Possible Solutions

(Time) - (Time)
(Time)
! 2nd: ! Pass the mandrel through the needle
Contamination No. 3 to unblock it (see procedure in
®
of needle No. 3 chapter 9.2.2. of the STA Compact
Operator’s Manual).
! Check the suction in washing well No.
3 (see procedure for cleaning washing
wells in chapter 9.2.2. of the STA
®
Compact Operator’s manual).
! Call your local authorized Service
Representative.

Short Short OK ! Contamination ! Pass the mandrel through the needle

of needle No. 3 No. 3 to unblock it (see procedure in
®
chapter 9.2.2. of the STA Compact
Operator’s Manual).
! Check the suction in washing well No.
3 (see procedure for cleaning washing
wells in chapter 9.2.2. of the STA
®
Compact Operator’s Manual).
®
! Replace the vial of STA - DESORB U.
! Call your local authorized Service
Representative.

®
! STA -DESORB
U contaminated
OK OK Long ! Sample ! Check the rinsing of needle No.1 (see
incorrectly pipetted procedure chapter 9.7.2.2. of the STA
®
(dilution) Compact Operator’s Manual).
! Pass the mandrel through needle No.1
to unblock it (see procedure in chapter
®
9.2.2. of the STA Compact Operator’s
Manual).
! Call your local authorized Service
Representative.

Short Short or Short or ! Needle No. 3 ! Check the rinsing of needle No.3 (see
or long long incorrect pipetting procedure chapter 9.7.2.2. of the STA
®
Compact Operator’s Manual).
long
! Pass the mandrel through needle No. 3
to unblock it (see procedure in chapter
®
9.2.2. of the STA Compact Operator’s
Manual).
! Replace the Teflon tip of the syringe:
(see procedure in chapter 9.3. of the
®
STA Compact Operator’s Manual).
! Call your local authorized Service
Representative.

10 - 10 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

10.4. Problems Related to the Test Execution

Problem Type Probable Causes Possible Solutions

! For a selected test, ! Test has been blocked by ! Unblock the test (see
analyses are not means of the File procedure, chapter 6.7.3. of
®
run. Modification menu (see the STA Compact
chapter 6.7.3. of the STA Operator’s Manual).
®
Compact Operator’s
Manual).Block is displayed in
red on the TEST PANEL
instead of the result for this
test.
! Products are missing to run ! View the TEST STATUS
the test. screen: the missing products
are displayed in red (see
chapter 8.1.3. of the STA
®
Compact Operator’s
Manual).
! For this test, the calibration is
not confirmed. ! Load the missing products if
necessary.
! View the TEST STATUS
screen, the calibration status
for the selected test is not:
Validated (see description,
chapter 8.1.3. of the STA
®
Compact Operator’s
manual).
! For the selected test, no ! Run the calibration of the
quality control has been run selected test.
for more than 24 hours.
! View the TEST STATUS
screen, the quality control
status for the selected test is
not: Validated (see
description, chapter 8.1.3. of
®
the STA Compact
Operator’s manual).
! Run a quality control for each
selected test.
! None of the assays ! The sample pipettings have ! Load if necessary the
is run. been blocked whether by the missing products (see the
Stop Sample Pipetting list in the TEST STATUS
function of the Status sub- screen)
menu (see description,
chapter 8.1.5.1. of the STA ! Run the missing calibrations
®
Compact Operator’s (see the list in the TEST
Manual) or from the TEST STATUS screen).
STATUS screen (see
description, chapter 4.12. of ! Run the missing controls
®
the STA Compact (see the list in the TEST
Operator’s Manual). STATUS screen).

V 1.0 – January 96 10 - 11
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

10.5. Other Problems Found

10.5.1. Power-on Problems

Problems Observed Probable Causes Possible Solutions

• No response ! The power cord is not ! Connect the power cord
fromkeyboard and connected. correctly.
®
STACompact does not ®
start. ! The wall socket is not ! Plug the STA Compact in
active. elsewhere.
! The main fuses have ! Replace the main fuses (see
blown. chapter 9.5.4. of the STA
®
Compact Operator’s
Manual).
! The instrument is ! Call your local authorized
defective. Service Representative.

10.5.2 Dirty Liquid Filters

Probable Causes:

®
– For the liquid filter related to the STA - Cleaner Solution bottle, inversion between the
®
STA - Cleaner Solution bottle and the used liquid bottle;
– For the liquid filter related to the suction tip, contamination due to suction of plasmas.

Procedure to Replace the Liquid Filters

•Cat. No.: 27458

CAUTION! Observe the proper precautions for handling biohazardous

materials in accordance with local existing regulations: use
disposable gloves.

® ®
– Switch off the STA Compact (see Power-off procedure, chapter 2.6.2. of STA Compact
Operator’s Manual);
– Open the right side;
®
– Remove the STA - Cleaner Solution bottle and the used liquid bottle;
– Remove the bottle support and the cover of the cable trough;
– Remove the protective plate;

10 - 12 V 1.0 – January 96
®
STA COMPACT OPERATOR’S MANUAL Troubleshooting

Fig.1- Location of the Liquid Filters

®
– Remove the old filters (avoid STA - Cleaner Solution to drop on the electrical parts), see their
location Fig. 1 above;
– Dispose of them in accordance with local existing regulations. Incineration is
recommended in most countries;
– Fit the new filters by positioning them according to figure 1, see above;
– Replace the various parts;
®
– Switch on the STA Compact and press the Delete key to access the User
Maintenance menu,
– Proceed with the needle purges (see below), those are very important to eliminate the air
bubbles.

START: User Maintenance menu displayed.

ACTIONS RESULTS
! Access the Maintenance menu:
! Press the ↑ key to reach ! The following window displays:
Maintenance, then confirm with the ↵
Initialization in progress
key. Please wait...

! The Maintenance menu appears:

Needle PurgeNeedle
ReplacementSyringe
Tip/Syringe
ReplacementSuction Tip
ReplacementHalogen Lamp
ReplacementDates of Recent
MaintenanceReturn to the Previous Menu
with the cursor on Needle Purge.

V 1.0 – January 96 10 - 13
®
Troubleshooting STA COMPACT OPERATOR’S MANUAL

ACTIONS RESULTS
! Access the Needle Purge menu:

! Press the ↵ key Needle Purge. ! The NEEDLE PURGE screen appears.
! The following windows appear:
Checks in progress
Please wait...

Home position in progress

Please wait...

Positioning in well
Please wait...

! Needle 1 Purge:
! Press the F1 key. ! Purge of Needle 1.
! Repeat Needle 1 Purge:
! Press the F1 key. ! Purge of Needle 1.
! Needle 2 Purge:
! Press the F2 key. ! Purge of Needle No. 2.
! Needle 3 Purge:
! Press the F3 key. ! Purge of Needle 3.

! Quit the Needle Purge menu:

! Press the Esc key. ! The following window displays:

Do you want to return
to the previous menu
Y/N ?

Esc = Cancel

! Press the Y key. ! Home positions of the arms.

! The Maintenance menu appears.
! Press the ↑ key to Return to the Previous ! Back to User Maintenance menu.
Menu, then confirm with the ↵ key.

! Return to the Main Menu:

! Press the ↑ key to Return to the Previous ! Same results as described in chapter 2.1. of
®
Menu, then confirm with the ↵ key. the STA Compact Operator’s Manual.

10 - 14 V 1.0 – January 96
CAP PIERCING OPTION

9, rue des Frères Chausson

92600 Asnières (FRANCE)

0931142C
Cap Piercing Option Table of contents

REVISION TABLE

VERSION OF SOFTWARE
DATE LIST OF THE MODIFICATIONS
THE MANUAL VERSION
V1.0 October 98 105.03 Original Version
V1.0 June 99 105.03 Revision Table
Chapter No.°1 – Page 3
• Modification of the preventive maintenance for
the needle No. 1 / piercing
V.1.0 March 00 105.03 Revision Table
Chapter No.1 – Pages 2 to 19

Note:
• Modifications of recommendations about the
tube using
• Development of preventive maintenance
explanation
• Development of component replacement
explanation
V1.0 November 00 106.xx
V1.0 January 01 106.xx Revision Table
Chapter 1 - pages 1 to 2
Note:
• Futher details about use of tubes
V1.1 March 02 106.06 Revision Table
Chapter 1 – All pages

Note:
• Modification of the daily preventive
maintenance
• Modification of the weekly preventive
maintenance
V1.2 November 02 106.06 Revision Table
Chapter 1.3 – page 1-2
Chapter 1.4 – page 1-3

Note:
• Indications about the minimum volume
• Modification of the daily maintenance
V1.3 February 03 From:106.06 Revision Table
Chapter 3 – pages 3-18 to 3-33

Note :
• Needle Protection

V1.3 – February 03 i
Cap Piercing Option Table of contents

1 PRESENTATION OF THE OPTION ...........................................................................1-1

1.1 BENEFITS ...................................................................................................................1-1

1.2 DESCRIPTION OF THE OPTION.....................................................................................1-1

1.3 RECOMMENDATIONS .................................................................................................1-2

2 SPECIFIC MAINTENANCE..........................................................................................2-3

2.1 DAILY PREVENTIVE MAINTENANCE ...........................................................................2-4

2.2 WEEKLY PREVENTIVE MAINTENANCE ....................................................................2-11

2.2.1 Piercing Pipetting Needle ................................................................................................................... 2-11

2.2.2 Piercing Electrovalve Tubing ............................................................................................................. 2-19

3 REPLACEMENT OF COMPONENTS ......................................................................3-20

3.1 REPLACING OF THE PIERCING NEEDLE ....................................................................3-20

3.1.1 Piercing needle decontamination ....................................................................................................... 3-21

3.1.2 Piercing needle replacing procedure.................................................................................................. 3-27

3.1.3 Preparing the decontamination solution ............................................................................................ 3-35

3.2 TUBING FOR THE CLAMPING ELECTROVALVE .........................................................3-35

V1.3 – February 03 i
Cap Piercing Option

1 PRESENTATION OF THE OPTION

1.1 Benefits

Loading of capped tubes in the instrument. This eliminates both the cap-removal procedure
as well as all other problems associated with this handling procedure, thereby reducing the
risk of contamination by the user.

1.2 Description of the option

A mechanical system is mounted on the pipetting head, ensuring the proper positionning of
the tube when piercing the cap.

The sample needle is modified in order to pierce the caps. The specific maintenance of this
modified needle, called “Piercing Needle” is described chapters 2.1 and 2.2.
The cap piercing option is managed by a specific software version.

The tube is held at its top due to a part called "Cap piercing foot" (stirrup).
There is two type of cap piercing feet, the first one for a concave tube cap and the second
one for a convex tube cap.

Convex cap piercing foot Concave cap piercing foot

(used for concave caps) (used for convex caps)

Please see the included notice No. 0931234x inter-tube compatibility.

V1.3 – February 03 1-1

Cap Piercing Option

1.3 Recommendations

Diagnostica Stago denies all responsibilities if the recommendations are not observed.

• Sample tubes which have been tested and removed from the instrument
must have their caps removed if they are going to be reloaded, otherwise
there is a risk of an erroneous result.

• Check that the tube filling conditions are observed (a misfilled tube may contain some
vacuum and may cause a wrong pipetting when the cap is pierced).

• Do not recap an uncapped tube (problem of overpressure in the tube).

• Make certain that there are no bubbles on the plasma surface.

• When a volume of reagent has been changed, you must unload the vial from the drawer
and load it back to enter the new volume figure.

• The minimum volume displayed in the methodologies is defined with a standard needle.
The cap piercing system uses another type of needle which increases this minimum
volume. The new dead volumes are:

- 2.2 ml for the diluent and the STA DESORB-U solution,

- 0.6 ml for controls and calibrators,
- 200 µl for STA-microcontainers
- 280 µl for STA-microcups.

For controls and calibrators, we recommend to use STA-microcups.

Note: Tubes which have been tested following the compatibility protocol with the cap
piercing system, are listed in the notice No. 0931234x: “Cap piercing option: List of
tubes”.

1-2 V1.3 – February 03

Cap Piercing Option

2 SPECIFIC MAINTENANCE

The maintenance described in the STA Compact Operator’s Manual remains applicable
except for the specific parts of the option i.e.: the piercing needle and the tubing of the new
electrovalve.

Warning : In the event this cleaning procedure is not followed properly, wrong results
could be obtained from diluted tests using 5 µl samples like ATIII.

FREQUENCY SPARE PARTS

Item
Daily or every 100 tubes
Weekly Qty per package
Whichever comes first
Reference

Soak the needle for 10 Soak the needle for 30 minutes Needle No. 1 / piercing
minutes in a tube filled with in a tube filled with
STA DESORB-U. STA DESORB-U. X1
Needle

S-999A718 39022

(See procedure section 2.1) (See procedure section 2.2) (See procedure section 3.1)

Displace the tubing from a few Tubing EV / Piercing

Tubing for the

millimeters .
Electrovalve

X6
Clamping

S-0051285 38581

(See procedure section 2.2.2)

V1.3 – February 03 2-3

Cap Piercing Option

2.1 Daily preventive maintenance

Purpose: Clean the outside and the inside of the piercing needle No. 1.

Observe the proper precautions for handling biohazardous materials in

accordance with local existing regulations: Use disposable gloves.

START: TEST PANEL screen displayed.

ACTIONS RESULTS
! Access the User Maintenance menu:
" Press the Esc key.
" The Main Menu is displayed:

Status - Loading -(...) - Halt

with the cursor on Status.

! Access the Rinsing Pump menu: " The User Maintenance menu is displayed:
" Press the ↵ key (Rinsing Pump) to
validate.

with the cursor on Rinsing Pump

" The following window is displayed:

with the cursor on Sample Needle Cleaning

2-4 V1.3 – February 03

Cap Piercing Option

ACTIONS RESULTS
! Access the Sample Needle Cleaning
menu:
" Press the ↵ key (Sample Needle
Cleaning) to validate. " The following windows are displayed:

" Then, the Sample needle cleaning window is

displayed:

" Type any key. " The following window is displayed:

" The sample drawer opens.

The following window is displayed:

" Place a tube filled with 5 ml of " The following window is displayed:
DESORB.

" Move the cursor with ↑, ↓ or ↵ keys, if

needed, to reach the daily maintenance.

" Press the key to tick off the

daily maintenance. ! Daily maintenance: 10 minutes
" Reach the area of time acquisition with ! Weekly maintenance: 30 minutes
↑, ↓ or ↵ keys to type in the desired
washing time.
" Press the F10 key to validate the " The following window is displayed:
washing time.

V1.3 – February 03 2-5

Cap Piercing Option

ACTIONS RESULTS
" Type any key. " The following window is displayed:

" Then, the following window is displayed:

" The piercing needle moves and goes down in

the tube filled with DESORB.
" Cleaning of the Needle No. 1.
" The following window is displayed:

" Countdown of the washing time.

Remark: To abort the washing process, press
simultaneously the Alt + F5 keys .

In case of interruption of cleaning

process followed by an emergency
stop (Alt+f10), the sampling needle
must be thoroughly wiped before
reinitializing the instrument.

" At the end of the cleaning process, the

following window is displayed:

2-6 V1.3 – February 03

Cap Piercing Option

" Type any key. " The product drawer opens and the following
message is displayed:

" The needle moves ahead and goes down.

" The following message is displayed:

" Raise the transparent panel

" Dry the piercing needle with a tissue
paper from top to bottom.
" Press the ↵ key to validate. " The following message is displayed:

" Type any key. " The following windows are displayed:

" Rinsing of the Needle No. 1.

" Type any key. " The following messages are displayed:

" Remove the tube of Desorb. " The following window is displayed:

V1.3 – February 03 2-7

Cap Piercing Option

" Type any key. " The piercing drawer closes and the following
window is displayed:

! Quit the Sample Needle Cleaning

screen.
" Go to the Return Previous Menu then
confirm with the ↵ key. " The User Maintenance screen is displayed:

! Access to the Maintenance menu: " The following window is displayed:

" Press the ↓ key to reach the
Maintenance then press the ↵ to
validate.

! Access the Dates of Recent " The Dates of Recent Maintenance screen is
Maintenance screen: displayed.
" Press the ↓ key to reach Dates of
Recent Maintenance then confirm with
the ↵ key.
" Press the keys ALT and PrtSc. " Printout of the Dates of Recent Maintenance
screen.
! Quit the Dates of Recent Maintenance
screen:
" Press the Esc key. " The following window is displayed:

" Press the Y key. " The Maintenance menu is displayed.

2-8 V1.3 – February 03

Cap Piercing Option

! Caution ! In case of low DESORB

" The following window is displayed:

" Press the Esc key.

" The following message is displayed:

" Type any key. " The following message is displayed:

" The needle moves ahead and goes down.

" The following message is displayed:

" Raise the transparent panel

" Dry the piercing needle with a tissue
paper from top to bottom.
" Press the ↵ key to validate. " The following message is displayed:

" Type any key. " The following windows are displayed:

" Rinsing of the Needle No. 1.

V1.3 – February 03 2-9

Cap Piercing Option

" Type any key. " The following messages are displayed:

" Remove the tube of Desorb. " The following window is displayed:

" Type any key. " The following windows are displayed:

with the cursor on Sample Needle Cleaning

Rerun the cleaning procedure with a tube filled with 5 ml DESORB

2-10 V1.3 – February 03

Cap Piercing Option

2.2 Weekly Preventive Maintenance

Purpose: Clean the outside and the inside of the piercing needle No. 1.

2.2.1 Piercing Pipetting Needle

Observe the proper precautions for handling biohazardous materials in

accordance with local existing regulations: Use disposable gloves.

START: TEST PANEL screen displayed

ACTIONS RESULTS
! Access the User Maintenance menu:
" Press the Esc key.
" The Main Menu is displayed:

Status - Loading -(...) - Halt

with the cursor on Status.

! Access the Rinsing Pump menu: " The User Maintenance menu is displayed:
" Press the ↵ key (Rinsing Pump) to
validate.

with the cursor on Rinsing Pump

" The following window is displayed:

with the cursor on Sample Needle Cleaning

V1.3 – February 03 2-11

Cap Piercing Option

ACTIONS RESULTS
! Access the Sample Needle Cleaning
menu:
" Press the ↵ key (Sample Needle
Cleaning) to validate. " The following windows are displayed:

" Then, the Sample needle cleaning window is

displayed:

" Type any key. " The following window is displayed:

" The sample drawer opens.

The following window is displayed:

" Place a tube filled with 5 ml of " The following window is displayed:
DESORB.

" Move the cursor with ↑, ↓ or ↵ keys, if

needed, to reach the weekly
maintenance.
! Daily maintenance: 10 minutes
" Press the key to tick off the
weekly maintenance. ! Weekly maintenance : 30 minutes
" Reach the area of time acquisition with
↑, ↓ or ↵ keys to type in the desired
washing time.
" Press the F10 key to validate the " The following window is displayed:
washing time.

2-12 V1.3 – February 03

Cap Piercing Option

ACTIONS RESULTS
" Type any key. " The following window is displayed:

" Then, the following window is displayed:

" The piercing needle moves and goes down in

the tube filled with DESORB.
" Cleaning of the Needle No. 1.
" The following window is displayed:

" Countdown of the washing time.

Remark: To stop the cleaning process, press
simultaneously the Alt + F5 keys .

In case of interruption of cleaning

process followed by an emergency
stop (Alt+f10), the piercing needle
must be thoroughly wiped before
reinitializing the instrument.

" At the end of the cleaning process, the

following window is displayed:

V1.3 – February 03 2-13

Cap Piercing Option

" Type any key. " The product drawer opens and the following
message is displayed:

" The needle moves ahead and goes down.

" The following message is displayed:

" Raise the transparent panel

" Dry the piercing needle with a tissue
paper from top to bottom.
" Press the ↵ key to validate. " The following message is displayed:

" Type any key. " The following windows are displayed:

" Rinsing of the Needle No. 1.

" Type any key. " The following messages are displayed:

" Remove the tube of Desorb. " The following window is displayed:

2-14 V1.3 – February 03

Cap Piercing Option

" Type any key. " The sample drawer closes and the following
window is displayed:

! Quit the Sample Needle Cleaning

screen.
" Go to the Return Previous Menu then
confirm with the ↵ key. " The User Maintenance screen is displayed:

! Access to the Maintenance menu: " The following window is displayed:

" Press the ↓ key to reach the
Maintenance then press the ↵ to
validate.

" The Maintenance menu is displayed:

with the cursor on Needle Purge

! Access the Needle Purge menu:
" Press the ↵ key Needle Purge.
" The following windows are displayed :

" Press the F1 key. " Purge of Needle No. 1.

V1.3 – February 03 2-15

Cap Piercing Option

! Quit the Needle Purge menu:

" Press the Esc key. " The following window is displayed:

" Press the Y key. " Home positions.

" The Maintenance menu is displayed..
! Access the Dates of Recent " The Dates of Recent Maintenance screen is
Maintenance screen: displayed.
" Press the ↓ key to reach Dates of
Recent Maintenance then confirm with
the ↵ key.
" Press the keys ALT and PrtSc " Printout of the Dates of Recent Maintenance
screen.
! Quit the Dates of Recent Maintenance
screen:
" Press the Esc key. " The following window is displayed:

" Press the Y key. " The Maintenance menu is displayed.

2-16 V1.3 – February 03

Cap Piercing Option

! Caution ! In case of low DESORB

" The following window is displayed:

" Press the Esc key. " The following message is displayed:

" Type any key. " The following message is displayed:

" The needle moves ahead and goes down.

" The following message is displayed:

" Raise the transparent panel

" Dry the piercing needle with a tissue
paper from top to bottom.
" Press the ↵ key to validate. " The following message is displayed:

" Type any key. " The following windows are displayed:

" Rinsing of the Needle No. 1.

V1.3 – February 03 2-17

Cap Piercing Option

" Type any key. " The following messages are displayed:

" Remove the tube of Desorb. " The following window is displayed:

" Type any key. " The following windows are displayed:

with the cursor on Sample Needle Cleaning

Rerun the cleaning procedure with a tube filled with 5 ml DESORB

2-18 V1.3 – February 03

Cap Piercing Option

2.2.2 Piercing Electrovalve Tubing

Purpose: To prevent a permanent deformation of the tubing

START: TEST PANEL screen displayed

ACTIONS RESULTS
! Access the User Maintenance menu:
" Press the Esc key.
" The Main Menu is displayed:

Status - Loading -(...) - Halt

with the cursor on Status.

" Press the M key: Maintenance. " The User Maintenance menu is displayed:
" Or press the → key to reach
Maintenance, then press the ↵ key to
confirm.

with the cursor on Rinsing Pump

Procedure :
− Press on the clamping electrovalve so that the tubing can be displaced from the top or
the bottom by a few millimeters. Do not position the tubing in the same place to avoid
any tubing deformation (see Figure 1).

Figure 1 – Electrovalve

V1.3 – February 03 2-19

Cap Piercing Option

3 REPLACEMENT OF COMPONENTS

These components must be changed when the original component is defective.

3.1 Replacing of the Piercing Needle

• Ref. : 39022 (for the Needle No. 1 “piercing”)

Each needle is delivered with a needle protection and a milled nut.

Figure 2 – Needle packaging

Aim : To protect the piercing needle until it is installed

WARNINGS AND STANDARD PRECAUTIONS

Never use the mandrel for the piercing needle

Avoid any contact with the needle extremity and perform a piercing needle
decontamination before replacing it

The decontamination procedure described below must be performed

prior to handling the piercing needle.

3-20 V1.3 – February 03

Cap Piercing Option

3.1.1 Piercing needle decontamination

Before replacing the piercing needle, you must perform a decontamination for your own
safety.

Observe the proper precautions for handling biohazardous materials in

accordance with local existing regulations: Use disposable gloves.

ACTIONS RESULTS
! Access the User Maintenance menu:
" Press the Esc key.
" The Main Menu is displayed:

Status - Loading -(...) - Halt

with the cursor on Status.

" Press the M key: Maintenance. " The User Maintenance menu is displayed:
" Or press the → key to reach
Maintenance, then press the ↵ key to
confirm.

with the cursor on Rinsing Pump

! Access the Rinsing Pump menu:
" Press the ↵ key (Rinsing Pump) to " The following window is displayed:
validate.

with the cursor on Sample Needle Cleaning

V1.3 – February 03 3-21

Cap Piercing Option

ACTIONS RESULTS
! Access the Sample Needle Cleaning
menu:
" Press the ↵ key (Sample Needle
Cleaning) to validate. " The following windows are displayed:

" Then, the Sample needle cleaning window is

displayed:

" Type any key. " The following window is displayed:

" The sample drawer opens.

The following window is displayed:

" Instead of using DESORB, Place a tube " The following window is displayed:
filled with 5 ml of the Decontamination
solution.

" Move the cursor with ↑, ↓ or ↵ keys to

reach the desired type of maintenance. ! Decontamination time: 15 minutes
" Press the key to tick off the
desired type of maintenance.
" Reach the area of time acquisition with
↑, ↓ or ↵ keys to type in the desired
washing time.
" Press the F10 key to validate the " The following window is displayed:
cleaning time.

3-22 V1.3 – February 03

Cap Piercing Option

ACTIONS RESULTS
" Type any key. " The following window is displayed:

" Then, the following window is displayed:

" The piercing needle moves and goes down in

the tube filled with the decontamination
solution.
" Cleaning of the Needle No. 1.
" The following window is displayed:

" Countdown of the washing time.

(Reminder: 15 minutes)
" At the end of the cleaning process, the
following window is displayed:

Remark: To stop the cleaning process, press simultaneously the Alt + F5 keys .

In case of interruption of cleaning process followed by an emergency stop (Alt+f10),

the piercing needle must be thoroughly wiped (from top to bottom) before
reinitializing the instrument.

WARNING :

IN CASE OF DECONTAMINATION PROCEDURE STOP, DO NOT PROCEED PIERCING

NEEDLE MANIPULATIONS:

RERUN THE DECONTAMINATION PROCEDURE

V1.3 – February 03 3-23

Cap Piercing Option

ACTIONS RESULTS
" Type any key. " The product drawer opens and the following
message is displayed:

" The needle moves ahead and goes down.

" The following message is displayed:

" Raise the transparent panel

" Dry the piercing needle with a tissue
paper from top to bottom.
" Press the ↵ key to validate. " The following message is displayed:

" Type any key. " The following windows are displayed:

" Rinsing of the Needle No. 1.

" Type any key. " The following messages are displayed:

" Remove the tube of Desorb. " The following window is displayed:

3-24 V1.3 – February 03

Cap Piercing Option

" Type any key. " The sample drawer closes and the following
window is displayed:

! Quit the Sample Needle Cleaning

screen.
" Go to the Return Previous Menu then
confirm with the ↵ key. " The User Maintenance screen is displayed:

! Access to the Maintenance menu: " The following window is displayed:

" Press the ↓ key to reach the
Maintenance then press the ↵ to
validate.

" The Maintenance menu is displayed:

! Access the Needle Purge menu:

" Press the ↵ key Needle Purge.
" The following windows are displayed :

V1.3 – February 03 3-25

Cap Piercing Option

" Press the F1 key. " Purge of Needle No. 1.

! Quit the Needle Purge menu:
" Press the Esc key. " The following window is displayed:

" Press the Y key. " The Maintenance menu is displayed.

3-26 V1.3 – February 03

Cap Piercing Option

3.1.2 Piercing needle replacing procedure

REMINDER:
Perform a procedure decontamination prior handling the piercing
needle (cf. section 3.1.1).

START: TEST PANEL screen displayed.

ACTIONS RESULTS
! Access the User Maintenance menu:
" Press the Esc key.
" The Main Menu is displayed:

Status - Loading -(...) - Halt

with the cursor on Status.

" Press the M key: Maintenance. " The User Maintenance menu is displayed:
" Or press the → key to reach
Maintenance, then press the ↵ key to
confirm.

with the cursor on Rinsing Pump

! Access to the Maintenance menu:
" Press the ↓ key to reach the " The following window is displayed:
Maintenance then press the ↵ to
validate.

" The Maintenance menu is displayed:

with the cursor on Purge Needle.

V1.3 – February 03 3-27

Cap Piercing Option

ACTIONS RESULTS
! Access the Needle Replacement
menu:
" The following window is displayed:
" Press the ↓ key to reach Needle
Replacement, then confirm with the ↵
key.

" The Needle Replacement menu is displayed:

Needle No. 1
Needle No. 2
Needle No. 3
Return to Previous Menu
with the cursor on Needle No. 1.
" Select the needle which has to be " The following window is displayed:
changed.
NEEDLE REPLACEMENT
" Press the ↵ key for the Needle No. 1

For this operation, you must have:

- a new needle
- the mapping cuvette

F10 : Continue - Esc : Abort

" Prepare a new needle and the mapping " Home positions in progress.
adjustment cuvette.
" Then press the F10 key to proceed.
" The following window is displayed :
NEEDLE REPLACEMENT

Drawer is going to open

Press any key
to proceed

3-28 V1.3 – February 03

Cap Piercing Option

" Press any key to proceed. " Opening of the Product Drawer.

" Pipetting head moves forwards.

" The following window is displayed:
NEEDLE REPLACEMENT

Once the transparent panel is raised, you

can change the needle according to the
procedure described in the manual.

When this operation is finished, validate by

pressing F10.

F10 : Validate - Esc : Abort

Observe the standard precautions concerning the handling of biohazardous

products in accordance with current local regulations : Wear disposable gloves
and observe the correct disposal procedure.

• Dismantling of the sampling needle:

− Raise the transparent panel.
− Place a tissue paper under the needle.

− Take the needle protection .

− Place it on the needle as indicated on the Figure 3.

Figure 3– Placing the needle protection

V1.3 – February 03 3-29

Cap Piercing Option

− Get the protection block on the low part of the milled nut.
− Remove the screw of the cap piercing foot (stirrup) - (see Figure 4).
− Remove the cap piercing foot.

Figure 4 – Needle holder assembly

− Disconnect the tubing from the metal connection the top of the head (see Figure 5).

Figure 5 - Dismantling of the metal connection

− Fully unscrew the milled nut of the needle holder assembly.

− Lower and remove the assembly : needle+tubing, milled nut and needle protection in
one action.
− Dispose this assembly (needle+tubing, milled nut and needle protection) in
accordance with current local regulations for sampling needles. Incineration is
recommended in most countries.

3-30 V1.3 – February 03

Cap Piercing Option

• Re-assembling of the Sampling Needle:

− Take a new needle+tubing assembly equipped with its protection and its milled nut.

Figure 6 - Needle and protection assembly

− Push the tubing into the needle holder from below.
− Check that the tubing is not stuck in the needle holder.
− Check that the needle base (see Figure 6) is totally inserted.
− Fully retighten the milled nut by hand.
− Reconnect the tubing to the metal connection at the top of the head.
− Remove the needle protection : Slip it from the bottom.
− Remove the tissue paper and eliminate it following the current local regulations.
− Store the needle protection in the accessories box.
− Check the positioning of the tubing and cables at the top of the pipetting head to avoid
any interference with arm movements.
− Check the connections of the level detection cable from the needle holder to the
electronic circuit board.

V1.3 – February 03 3-31

Cap Piercing Option

ACTIONS RESULTS
" Press the F10 key to validate this " Needle replacement is validated.
procedure. " The following window is displayed only if the
level detection for the required arm is
managed:
NEEDLE REPLACEMENT

Level detection test.

Please use finger to touch the needle

you have just installed.

You have 20 seconds ...

" Take the needle on its top with your " The following screen is displayed whether the
fingers : an audible “beep” is emitted. level detection is managed or not:
" Caution! There are only 20 seconds to NEEDLE REPLACEMENT
perform this operation.

Please follow these instructions:

1° Place the mapping cuvette in the

incubation position No.16.

2° Lower the transparent panel.

F10 to continue
" Place the mapping cuvette in the " Home positions.
incubation position No.16
(see chapter 3.8.1 of the
Operator's Manual).
" Lower the transparent panel. " The following window is displayed:
" Press the F10 key to validate this NEEDLE REPLACEMENT
procedure.

Please follow these instructions:

1° Raise the transparent panel.

2° Adjust the X and Y positions of the

needle with keyboard.

3° When the adjustment is finished,

validate.

↑ / ↓ : Y adjustment - ←/ →: X adjustment
F10 : Validation

3-32 V1.3 – February 03

Cap Piercing Option

ACTIONS RESULTS
" Raise the transparent panel.
" Lower manually the selected needle " The following window is displayed:
holder to see if the needle can enter into
the central hole of the mapping NEEDLE REPLACEMENT
adjustment cuvette.
Manually adjust the Z position.
* If YES, press the F10 key. Lower the transparent panel, then
* If NO, take the needle by its midle validate with F10 when all is finished.
and twist the needle until it can
enter into the middle hole of the
F10 : Validation
mapping adjustment cuvette, then
confirm with the F10 key.
Note : DO NOT USE the moving cursor
keys (↑, ↓, ←, →) to move the
needle AND DO NOT MOVE the
needle holder along the X and Y
axis during these adjustments.
" Plunge the needle to the bottom of the " Home positions.
hole of the mapping adjustment cuvette
" Lower the transparent panel. " Then, the following window is displayed:
" Press the F10 key to validate the above NEEDLE REPLACEMENT
operations.

Drawer is going to close,

Press any key to proceed

" Press any key to close the product " The drawer closes
drawer.
" The following window is displayed:
NEEDLE REPLACEMENT

Please raise transparent panel

to retrieve mapping cuvette.
Then lower transparent panel.

F10 to proceed

" Raise the transparent panel. " The following window is displayed:
" Retrieve the mapping adjustment NEEDLE REPLACEMENT
cuvette.
" Replace the cap piercing foot (stirrup)
and screw the milled nut back. The procedure was
" Lower the transparent panel. successful.
" Press the F10 key to validate the above
operations.
F10 to proceed

V1.3 – February 03 3-33

Cap Piercing Option

ACTIONS RESULTS
" Press the F10 key to proceed " The Needle Replacement menu is displayed.

" Press the ↓ key to Return to Previous " The Maintenance menu is displayed.
menu, then confirm with the ↵ key.
! Access the Needle Purge menu: " The NEEDLE PURGE screen is displayed.
" Press the ↵ key Needle Purge. " Home positions.
" The needles go to their respective washing
wells.
! Needle 1 Purge:
" Press the F1 key. " Purge of Needle No. 1.
! Quit the Needle Purge menu:
" Press the Esc key. " The following window is displayed:
Do you want to return
to the previous menu
Y/N ?

Esc = Cancel

" Press the Y key. " Home positions.

" The Maintenance menu is displayed.
! Access the Dates of Recent " The Dates of Recent Maintenance screen is
Maintenance screen: displayed.
" Press the ↓ key to reach Dates of
Recent Maintenance then confirm with
the ↵ key.
" Press the keys ALT and PrtSc " Printout of the Dates of Recent Maintenance
screen.
! Quit the Dates of Recent Maintenance
screen:
" Press the Esc key. " The following window is displayed:
Do you want to return
to the previous menu
Y/N ?

ESC = Cancel

" Press the Y key. " The Maintenance menu is displayed.

" Press the ↓ key to Return to the " Back to User Maintenance menu.
Previous Menu, then confirm with the
↵ key.
! Return to the Main Menu:
" Press the ↓ key to Return to the " See chapter 2.1. of the Operator’s
Previous Menu, then confirm with the Manual.
↵ key.
! Run quality controls for the routine tests. " If the quality control results are consistent with
! Compare results to the previous ones. the previous ones, can be used.
" If not, redo the needle adjustment procedure.
In case of problem, call your local authorized
Service Representative.

3-34 V1.3 – February 03

Cap Piercing Option

3.1.3 Preparing the decontamination solution

Prepare a decontamination solution at 0.37% of active chlorine:

For examples:
− Bleach at 9.6% of active chlorine
Mix 1 volume of 9.6% active chlorine solution with 25 volumes of water

− Bleach at 6% of active chlorine

Mix 1 volume of 6% active chlorine solution with 15 volumes of water

For other concentration, add N volumes of water to 1 volume of bleach :

N = [(Bleach concentration in % / 0.37) - 1]

3.2 Tubing for the Clamping Electrovalve

• Ref. : 38581

• Remove the tubing of the clamping electrovalve:

− Remove the tubing protection from its place.
− Push on the electrovalve in order to remove the tubing from the electovalve
(see Figure 7).
− Remove the electrovalve tubing.

Figure 7 – Electrovalve tubing

− Dispose of the tubing in accordance with the regulation applicable locally for the
collection needles. Incineration is recommended in most countries.

V1.3 – February 03 3-35

Cap Piercing Option

• Put the tubing for the clamping electrovalve into place:

− Position the tubing at the top.
− Press on the electrovalve so that the tubing can be placed inside the electrovalve,
− Position the tubing below,
− Put the tubing protection.

3-36 V1.3 – February 03

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