Art no 1504156 September 2006

Contents
PREFACE ............................................................................................................................................ 3
Introduction ................................................................................................................................... 3

SECTION 1: SAFETY INSTRUCTIONS .................................................................................................. 5

Section Overview ........................................................................................................................... 5
1.1 Intended Use ............................................................................................................................ 5
1.2 Safety Instruction .................................................................................................................... 6
1.3 Biohazards ................................................................................................................................ 6
1.4 Emergency Procedure ............................................................................................................. 7
1.5 Warning Signs in Manual ....................................................................................................... 7
1.6 Signs on Equipment................................................................................................................. 8

SECTION 2: INSTALLATION .............................................................................................................. 10

Section Overview ......................................................................................................................... 10
2.1 Unpacking / Operating Placement & Environment ........................................................... 10
2.2 Installation Checklist and Menu ......................................................................................... 12
2.3 Analyzer Cable, Interface, and Printer Connections ......................................................... 14
2.4 Reagent Installation............................................................................................................... 15
2.5 Changing Reagents ................................................................................................................ 18
2.6 Power Supply ......................................................................................................................... 18

SECTION 3: GENERAL OVERVIEW .................................................................................................... 20

Section Overview ......................................................................................................................... 20
3.1 General Instrument Overview.............................................................................................. 20
3.2 Menu Structure...................................................................................................................... 21
3.3 System Flow ........................................................................................................................... 23
3.4 Sample Volume, Throughput, and Parameters .................................................................. 24

SECTION 4: INSTRUMENT SETUP ..................................................................................................... 25

Section Overview ......................................................................................................................... 25
4.1 Menu Selection ....................................................................................................................... 25
4.2 Initial Setup ............................................................................................................................ 26
4.3 Advanced Setup ..................................................................................................................... 27
4.4 Reagent Setup ........................................................................................................................ 31
4.5 User Interface ........................................................................................................................ 33

SECTION 5: SAMPLE ANALYSIS ......................................................................................................... 36

Section Overview ......................................................................................................................... 36
5.1 Preparations before Analysis................................................................................................ 36
5.2 Startup Sequence .................................................................................................................. 37
5.3 Background Count ................................................................................................................ 39
5.4 Sample Identification ............................................................................................................ 39
5.5 Analyzing the Sample (Open Tube) ..................................................................................... 40
5.6 Analyzing the Sample (Pre-dilution procedure) ................................................................. 42
5.7 Analyzing the Sample (Micro Capillary Inlet, MCI) ......................................................... 44
5.8 Analyzing the Sample (Cap Piercing Device)...................................................................... 47
5.9 Analyzing the Sample (Auto Sampler) ................................................................................ 48
5.10 Results................................................................................................................................... 52

SECTION 6: QUALITY CONTROL (QC) AND BLOOD CONTROL MEMORY ....................................... 54

Section Overview ......................................................................................................................... 54
6.1 Quality Control (QC) ............................................................................................................ 54
6.2 Levey-Jennings Plots ............................................................................................................. 57
6.3 Initialization and Use of Xb Function .................................................................................. 58

1
SECTION 7: CALIBRATION ................................................................................................................ 59
Section Overview ......................................................................................................................... 59
7.1 Preparations before calibration ........................................................................................... 59
7.2 Calibration ............................................................................................................................. 60

SECTION 8: CLEANING, MAINTENANCE & TRANSPORT ................................................................. 63

Section Overview ......................................................................................................................... 63
8.1 Daily Cleaning........................................................................................................................ 63
8.2 Monthly Cleaning .................................................................................................................. 64
8.3 Six (6) Month Cleaning ......................................................................................................... 65
8.4 Instrument Maintenance....................................................................................................... 65
8.5 Re-location of instrument (within the laboratory) ............................................................. 66
8.6 Short Term Shutdown (<12h) .............................................................................................. 66
8.7 Re-packaging and Long Term Transport (>12h) ............................................................... 67
8.8 Permanent Shut-Down and Storage .................................................................................... 68
8.9 Disposal Information ............................................................................................................. 68

SECTION 9: PARAMETER AND SYSTEM INFORMATION MESSAGES .................................................. 69

Section Overview ......................................................................................................................... 69
9.1 Out-of-Range and Information Message Indicators .......................................................... 69
9.2 System Information Messages .............................................................................................. 70
9.3 Parameter Limitations of Automated Blood Cell Counters .............................................. 72

SECTION 10: TECHNOLOGY .............................................................................................................. 76

Section Overview ......................................................................................................................... 76
10.1 Measuring Principles........................................................................................................... 76
10.2 Counting Time RBC & WBC ............................................................................................. 77
10.3 WBC Differentials ............................................................................................................... 78
10.4 Photometric Method – HGB Hemoglobin ......................................................................... 79
10.5 Parameter Definitions ......................................................................................................... 79

SECTION 11: SPECIFICATIONS........................................................................................................... 81

Section Overview ......................................................................................................................... 81
11.1 General ................................................................................................................................. 81
11.2 Short List of Specifications ................................................................................................. 82
11.3 Parameter Ranges ............................................................................................................... 83
11.4 Reagents and Reagent Consumption ................................................................................. 84

SECTION 12: TROUBLESHOOTING .................................................................................................... 85

Section Overview ......................................................................................................................... 85
12.1 Communication Issues ........................................................................................................ 85
12.2 General Information Displays ............................................................................................ 87
12.3 Warning Displays ................................................................................................................ 92
12.4 Aspiration Issues.................................................................................................................. 97
12.5 Troubleshooting Other Issues ............................................................................................ 98

INDEX ............................................................................................................................................... 99
APPENDIX A.................................................................................................................................... 100
APPENDIX B ................................................................................................................................... 108

2
 Preface
Introduction

Instrument Swelab Alfa 3-part hematology analyzer produced by Boule Medical for
description human application.

Serial number Serial number is located on the rear of the instrument.

Serial number

Software version

Figure 1.1 Figure 1.2

Software version The software version is displayed when starting up the instrument.

Instrument List of models

Product code Product name

1400014 Alfa Basic 16 16p
1400015 Alfa Stand. 16p CL MCI MIX QC
1400016 Alfa Stand. 20p CL MCI MIX QC
1400017 Alfa Cap 16p CL MCI QC
1400018 Alfa Cap 20p CL MCI QC
1400019 Alfa Cap 16p CL MCI QC ABR
1400020 Alfa Cap 20p CL MCI QC ABR
1400022 Alfa S BD 20p CL MCI QC
1400023 Alfa S BD 16p CL MCI QC ABR
1400024 Alfa S BD 20p CL MCI QC ABR
1400063 Alfa Basic 20p
1400069 Alfa S Sarst 16p CL MCI QC
1400070 Alfa S Sarst 20p CL MCI QC
1400072 Alfa S Sarst 20p CL MCI QC ABR

3
Additional Additional documentation is available from your authorized distributor.
Documentation Current additional documentation is listed below:
 Service Manual
 Boule Case Book
 User Definable Settings
 Basic Hematology
 Product data sheets

Operator requirements The following operator requirements must be fulfilled before operating
the Swelab Alfa hematology system.
 Basic skills in a laboratory environment.
 Basic skills in hematology.
 Awareness of IVD (EU)/FDA (US) requirements regarding laboratory
equipment.
 The operator must read and understand this manual.

Optional accessories Accessories and consumable lists are available from your local
and consumables distributor.

Manufacturer’s details Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20
Email: [email protected]

Distributor details Please contact Boule for information.

International SS-EN ISO 18113-3:2011

standards and IVD 98/79/EG
regulations SSEN 61010-2-101 (Low Voltage Directive 2006/95/EC)
EN 61326 (2006) (EMC 2004/108/EC)
2012/19/EU WEEE
Standards harmonized with FDA

Date of Issue Sept. 2014 Article no: 1504421

Software version Firmware 2.9.3

Third-party Software For information see Appendix B.

4
 Section 1: Safety Instructions
Section Overview

Introduction This section describes the safety features and warnings associated with the
Swelab Alfa.

Contents This section contains the following topics:

Topic See Page

Intended Use 5
Safety Instructions 6
Biohazards 6
Emergency Procedures 7
Warning Signs in Manual 7
Signs on Equipment 9

1.1 Intended Use

Description The Swelab Alfa is a fully automatic hematology analyzer intended for in vitro
diagnostic testing of human blood samples under laboratory conditions.

Operator Operator must have basic laboratory skills and be aware of good laboratory
Requirements practice.

Warranty  Service must be performed by Boule Medical AB (hereafter referred to as

limitations Boule) or by service personnel authorized by Boule.
 Use only original spare parts and Boule authorized reagents, blood controls,
calibrators and cleaners. (If these products are substituted it may void your
warranty)
 Operators and laboratory supervisors are responsible that Boule products are
operated and maintained according to the procedures described in manuals,
control inserts and technical bulletins.

Warranty  Each Boule system is tested using recommended reagents, blood controls,
limitations in calibrators and cleaners. All performance claims are generated as part of this
depth complete system.
 Boule products do NOT make diagnoses on patients. Boule intends its
diagnostic products (systems, software and hardware) to be used to collect
data reflecting the patient’s hematological status. This data, in conjunction
with other diagnostic information and the evaluation of the patient’s
condition, can be used by a trained clinician to establish a patient’s diagnosis
and to define clinical treatment.

5
1.2 Safety Instruction

Description Boule incorporates safety features within the instrument in order to protect the
operator from injury, the instrument from damage and the test results from
inaccuracies.

Restrictions In order to insure the safety of the operator and instrument follow the
instruction below:
 Do not use the instrument outdoors.
 Do no modify the instrument.
 Do not remove the cover. (Authorized personnel only)
 Do not use the instrument for other purposes than described in this manual.
 Do not spill blood or other fluids on the instrument in such a way that it can
leak through the instrument casing. (This might result in electrical
malfunction or personal injury)

 Unauthorized modification of the instrument might result in erroneous

results or risk for electrical shock.
 Spilling fluids into the instrument might cause electrical malfunction and/or
Important
personal injury.

Handling of  If a reagent comes in contact with eyes, rinse with running water for several
reagents minutes. If symptoms occur seek medical attention.
 If the reagent comes into contact with skin, wash affected area with water.
 If swallowed, rinse out mouth. If persistent symptoms occur seek medical
attention.

1.3 Biohazards

Description As there are no assurances of the absence of HIV, Hepatitis B or C viruses or

other infectious agents in blood samples, blood controls, calibrators and waste
these products should be handled as potentially biohazardous.

Support  Protection of Laboratory Workers From Infectious Disease Transmitted by

documentation occupationally acquired infections – 2nd Edition, Approved Guidelines
(2001) Document M29-T2 promulgated by the Clinical and Laboratory
Standards Institute, CLSI (NCCLS).
 Follow local regulatory documentation.

Handling of  Use universal precautions when handling samples and discarding waste.
biohazardous  Handle any exposure according to established laboratory protocol
material regulations.

6
1.4 Emergency Procedure

In case of If there are any obvious signs of malfunction such as smoke or liquid leaking
emergency out of the instrument proceed as follows:

Step Action
Disconnect the main power supply immediately by pulling out the
1
cord from the main supply.
2 Contact your authorized distributor.

1.5 Warning Signs in Manual

Warning Signs The following warning signs in the manual are used to identify possible
hazards and to call on the operator’s attention to this condition.

Sign Function

Indicates operation procedures that could result

in personal injury or loss of life if not correctly
followed.
Warning

Indicates operation procedures that could result

in damage or destruction of equipment if not
strictly observed.
Caution

Emphasizes operating procedures that must be

followed to avoid erroneous results.
Important

Indicates that protective clothing, gloves or gog-

gles must be used when performing described
procedures.
Mandatory Action

7
1.6 Signs on Equipment

Description Signs placed on the instrument define areas that need special attention or areas
that contain danger. See IVD Symbol Table on page 9.

Signs on equipment

Figure 1.3 Figure 1.4

Figure 1.5 Figure 1.6

8
 Batch code Serial number Catalogue number Manufacturer

Authorised*
Fragile, handle with
Representative in the Biological Risks Use by
care
European Community

In vitro diagnostic Lower limit of Upper limit of Temperature

medical device temperature temperature limitation

CONTROL L 16 CONTROL N 16

Consult instructions Low control, 16 Normal control, 16

Control
for use parameters parameters
CONTROL H 16

High control, 16
Calibrator Content Recycling
parameters
Figure 1.7 IVD Symbol Table

9
 Section 2: Installation
Section Overview

Introduction This section describes how to unpack and install the Swelab Alfa instrument.

Contents This section contains the following topics:

Topic See Page

Unpacking / Operating Placement and Environment 10
Installation Checklist and Menu 12
Analyzer Cable, Interface, and Printer Connections 14
Reagent Installation 15
Changing Reagents 18
Power Supply 18

2.1 Unpacking / Operating Placement & Environment

Description The instrument is packed in a specifically designed protective box.

Visual Checking Check the box for physical damage. If damaged notify your carrier
immediately.

Included  Instrument
Material  User’s Manual
 Quick Reference Guide
 Waste line
 Reagent Level Sensor and reagent caps for isotonic diluent (Diluent)
 Reagent Level Sensor and reagent caps for hemolyzing reagent (Lyse)
 Power adapter and cord
 Installation form
 Declaration of Conformity
 Barcode reader

Optional  Printer
Material  Printer paper
 MCI kit
 Sample wheels and control tube adapter (Auto Sampler model only)
 External Keyboard
 Boule reagents, blood controls, calibrators and cleaning kit

10
2.1 Unpacking / Operating Placement & Environment (continued)

The following procedures must be followed exactly. Boule has no

responsibility in case of faulty or erroneous installation.
Important

Installation/ The instrument should be placed in a laboratory environment according to the

Operating guidelines below:
Placement  Place the instrument on a clean horizontal surface.
 Avoid lifting the analyzer by the front cover.
 Avoid exposure to sunlight.
 Make sure the instrument has access to proper ventilation. The instrument
should have at least 5 cm (2 inches) of air above it.
 Place the rear of the instrument so it has at least 10 cm (4 inches) of free
space behind it.

5 cm

10 cm

Figure 2.1

Installation/  Indoor Use

Operating  Temperature +18 to +32 ºC (64 to 90 ºF)
Environment
 Humidity < 80% Relative
 Grounded main supply

Operating the instrument in an environment over +32 °C (90°F) increases

service needs, as well as degradation of sample specimen.
Important

11
2.2 Installation Checklist and Menu

Description Follow the quick Installation Checklist and Installation Menu step by step for
best installation results. For more detail on each step refer to Sections 2.3 – 2.6.

Installation Checklist
Complete Unpacking / Operating Placement and Environment instructions in Section 2.1.
Connect the power adapter to the back of the analyzer, but do not plug it into an electrical
socket.
Connect the printer. (If not using Distributor provided printer see Section 4.3.)
Connect the barcode reader to the back of the analyzer.
Connect the waste line to the analyzer and plumb to waste container or drain.
Connect the Diluent level sensor (red) and the electronic sensor to the analyzer.
Connect the Lyse reagent level sensor (yellow) and the electronic sensor to the analyzer.
Plug the power cord into the power adapter and the electrical socket to power up the analyzer.
After system initialization follow Installation Menu instructions below.

Installation Menu The following Installation Menu instructions were created to make
installation as quick and easy as possible. After completing the following
five steps (Step 5 is optional) on the Installation Menu, the system will be
ready for the first sample analysis.

The following Installation Menu Steps must be followed in sequential order.

Important

Step Action
Press Step 1 [SET DATE & TIME], set date and time, and press [EXIT] to return
1
to Installation Menu.

Figure 2.2 Figure 2.3

12
2.2 Installation Checklist and Menu (continued)

Step Action
Press Step 2 [ENTER REAGENT BARCODES].
 Scan barcode 1 and then barcode 2 on the Diluent container. (Press and hold the
ACTIVE or ON button each time a barcode is scanned.)
o If using a Combination pack, following instruction for scanning in Diluent
2 container.
 If using single containers of Diluent and Lyse press [ENTER ANOTHER
BARCODE] and scan barcode 1 and then barcode 2 on the Lyse container.
 Press [EXIT] to return to Reagent Barcode Input screen and then press [EXIT] again
to return to the Installation Menu.
After reagents are scanned, then loosen reagent container caps, remove factory seals, and
Note place reagent level sensors in respective containers.

Figure 2.4 Figure 2.5

Press Step 3 [ENTER CONTROL BARCODES] to enter assay value ranges into the
system for the lot of Control being used.
3  Scan barcodes 1-9, in that order, for each control level.
 Once accepted press [EXIT] to return to Installation Menu.
Press Step 4 [PERFORM FILL SYSTEM] to fill system with reagents. This cycle will
4
last for approximately 3 minutes.

Figure 2.6 Figure 2.7

Optional Press Step 5 [GO TO STARTUP]. See Section 5.2 for details on guided startup sequence.

13
2.3 Analyzer Cable, Interface, and Printer Connections

Description All connections are located on the rear panel of the instrument. The
connections available are as stated below:

2
4

6
5

Figure 2.8

Number Part Function

1 USB host ports Connects analyzer to USB devices
2 Electronic Sensors Connects Reagent level sensors to analyzer.
3 Power Supply port Connects Main power outlet to analyzer.
4 Power switch Switches power On and Off.
5 Ground Connector Connects Ground connector to analyzer.
6 USB Device Port Connects analyzer to USB host

Printer The printer is connected to the rear of the instrument with USB printer cable.
Connection (Printer is not manufactured by Boule.) See Figure 2.8.

Supported DPU 411/2 and DPU 414 (Supplied by Boule as an optional accessory).
Printers Follow the instructions in the printer user’s manual to install.

Compatible HP-PCL compatible, IBM Proprinter compatible, or supported USB printers.

Printers If using one of these printers see Section 4.3 for setup instructions.

14
2.4 Reagent Installation

Description The reagents for the instrument are delivered in cube formed boxes with
plastic caps.

Supported Hemolyzing reagent and Isotonic Diluent, hereafter referred to as Lyse and
Reagents Diluent. (Specifically designed by Boule for the Swelab Alfa system.)

This section describes placement of reagent containers.

Location of
Reagent
 It is recommended that both the Diluent and the Lyse reagents are placed at
the instrument level or below.

Placing the reagent containers above the instrument level could cause system
flow issue and is not recommended.
Caution

Connecting Reagent
This section describes how to connect the reagent containers for use.
Containers

Step Connect
The Lyse reagent level sensor (yellow) and the electronic sensor to the
1
analyzer.
2 The Diluent level sensor (red) and the electronic sensor to the analyzer.

Figure 2.9

Continued on next page

15
2.4 Reagent Installation (continued)

Step Insert
3 The reagent level sensors into the corresponding reagent containers.

Figure 2.10

Waste Connect the waste line to the analyzer. Place the other end of the waste line
directly into the drainage system or into a waste container, following local
regulations. See Section 8.9 for Disposal information.

The end of the waste line must be at a lower level than the instrument itself.
Not following this may lead to improper instrument functions and/or waste
liquid flowing backwards into the instrument.
Caution

Always use protective gloves when working with the waste container and the
waste line.
Mandatory Action

Fill System  For initial fill of analyzer, plug in analyzer and turn On/Off switch to ON.
 Press [EXIT] button upon display of Fill prompt, and follow the instructions
below to fill analyzer.

Continued on next page

16
2.4 Reagent Installation (continued)

Step Action
1 Select MENU tab.
2 Press [REAGENT SETUP] and then press [ENTER NEW REAGENTS].
Scan in barcodes on reagent containers, when all barcodes are entered a
screen will display that reagent barcodes have been accepted.

Figure 2.11 Figure 2.12

4 Return to MAIN Menu and press [ADVANCED].
5 Press [MAINTENANCE] and then [FILL SYSTEM].

Figure 2.13 Figure 2.14 Figure 2.15

The system is now filling up with reagents. This cycle will last for
6
approximately 3 minutes.

Print All After initial setup, it is recommended to print all analyzer settings and keep for
Settings personal records. Select [ADVANCED] from Main Menu, then [SETUP], and
then [PRINT ALL SETTINGS].

Factory All sample analysis modes (open tube, pre-dilute, MCI, cap piercer, sampling
Calibration device) are factory calibrated. However, calibration should always be checked
upon installation. See Section 7 for more details.

17
2.5 Changing Reagents

Description The interlocked reagent system displays indicator and warning messages to alert
the operator when reagents are running low and need to be changed. When this
occurs perform the following:
Step Action
1 Select [MENU] to access the Main menu and then select [REAGENT SETUP].
2 Select [ENTER NEW REAGENT].
Scan Barcode 1 and then Barcode 2 on the reagent container. Press and hold the
3
ON button on the barcode reader each time a barcode is scanned.
When all barcodes are entered a screen will display that reagent barcodes have
4
been accepted.
5 Select [EXIT] to return to the Main menu.
6 Remove the cap and seal on the new reagent container.
Transfer the reagent level sensor from the used container to the new reagent
7
container.
The analyzer is now ready to resume operation or analyze samples. No priming or
8 fill cycle is necessary when putting on a new reagent container, if indicator and
warning messages are followed.

A reagent alarm will display when at least one of the reagent containers is running
low, empty, or expired. Once alarm is displayed it will continue to display after
Important each sample run until the indicated container is changed.

2.6 Power Supply

Main supply The main power supply is located internally and designed to be operated
environment indoors. The power supply is safe for transient voltage as defined in
IEC 801-4.

Electrical shock hazard.

 The instrument must only be connected to a grounded mains supply.
Violating this might result in injuries and/or loss of life and/or erroneous
Warning parameter results.

Handling high If high voltage transients are expected on the main supply, please follow the
transient voltage recommendations below.

When cycling the power switch from power on – power off – power on, it is
recommended to have a delay of 3 seconds after power off. If the power
switch is cycled back to power on too quickly, sensitive components in the
Important instrument electronics may get damaged.

18
2.6 Power Supply (continued)

Electrical shock hazard.

 Installation of external electrical equipment such as CVT must only be
carried out by authorized service engineers. Violating this might result in
Warning
injuries and/or loss of life and/or erroneous parameter results.

In case of Symptom Solution

High transient -High background counts A CVT (magnetic stabilizer) should
voltage above on RBC, PLT or WBC. be implemented to keep the
15% -Defective instrument. instrument from being damaged. (In
general, avoid the use of an UPS.)

Guidelines Guidelines are given in the Service Manual, “Installation auxiliary devices”
section. Contact your authorized distributor in such a case.

Power In case of an abrupt power loss there will be no damage done to the
interruptions instrument. Calibration constants and other parameters necessary for operation
are protected against main supply loss.

Before In order to run the instrument, the frequency and main voltage needs to
connecting correspond to user’s power outlet.
 Locate the serial number plate on the rear of analyzer and check that the
main voltage and frequency corresponds to local main outlet.
 If voltage and/or frequency does not correspond, then contact your
authorized distributor

Connecting Insert power adapter into the instrument’s main power inlet and connect it to
Power Adapter the main power supply. (This should only be performed after connecting the
reagent containers.)

19
 Section 3: General Overview
Section Overview
Introduction This section contains general information about the instrument and optional
accessories.

Contents This section contains the following topics:

Topic See Page
General Instrument Overview 20
System Menu 21
System Flow 23
Sample Volume, Throughput, and Parameters 24

3.1 General Instrument Overview

9
Instrument
Overview

7 4

3 8 6
2
Figure 3.1

Part Function
TFT-LCD touch screen, color, with incorporated keyboard and
1. Display
numerical pad.
2. Whole Blood needle Aspirates whole blood.
3. Pre-dilute needle/Dispenser Aspirates pre-diluted samples and dispenses diluent.
4. MCI (optional) Micro Capillary Inlet enables the user to analyze 20 µl of blood.
5. Printer (optional) Prints sample results. (Not shown, model is user dependent)
Barcode reader enables user to quickly enter patient, control, and
6. Barcode reader
reagent pack identifications, and utilize the QC program.
7. Mixer (optional) Uniformly mixes samples.
8. Sampling Device (optional) Enables consecutive samples to be analyzed automatically.
9. Cap Piercer (optional) Analyzes samples with decreased risk of blood contact.

20
3.2 Menu Structure

Flowchart 3.1 Main Menu Structure

Select Analysis Profile

New Sample 11 possibilities of Analysis profiles
ID_______ Next
Main Menu 1,2,3..CE.. Prev
New Sample > Set Profile > Ok
Sampling Device (optional) > Next Profile
Prev Profile
Sample > Run Con/Cal > Run Con/Cal Sample
List > Operator ID > 12 possibilities of Con/Cal Lots
Menu A,B,C.. 1(4) > Next
Prime System ÅåÖö...1 (4) (optional) > Prev
Dispense Ok ¤ Cancel
Power Down Cancel <
Standby Sampling Device List
Advanced > Pos St. SEQ ID
Q/C > Sample
New Sample > Input ID
Reagent Setup >
Sampling Device (optional) > Start
ExtraMix
[GRAPH WBC] Pause
[GRAPH RBC] Stop
[GRAPH PLT]
Continue
[PARAMETER RESULT]
Exit
!
Prev ¤
1/4 ABC
Next ¤
2/4 abc
1(3) > 3/4 123...!?/...CE
List > 4/4 ÅåÖö… (optional)
Menu > Ok
Print Cancel

List Select Sample Criteria

New Sample > ID __________________
Sampling Device (optional) > Seq (fr-to) ____________
Sample Date (fr-to)____________
Search > Profile
Today
[SEQ. x-y LISTED] Select All
Previous ¤ Selected __/__
Next ¤ Exit
1(6) (param. listed) > Delete
Menu > Send
Print
Stats
Q/C Menu
View Con/Cal >
View Xb Stats >
Enter Con/Cal >
Reagent Barcode Input
View Assays >
Input manually >
Exit <
Exit >

View Reagent Statistics

Reagent Setup Menu Current Lyse/Diluent
Enter New Reagent > Cycles Left
Lot No./Pack No.
View Reagents >
Exp. Date
Inactivate Reagent > Open Date/Last Date
Print
Exit

Inactivate Reagent
Yes >
No >

21
3.2 Menu Structure (continued)

Flowchart 3.2 Advanced Menu Structure

22
3.3 System Flow

Description This section contains the system flow concerning standby and cleaning cycles.

Flowchart 3.3 System Flow

After 15 minutes*

Screen Saver
Mode**

After 2 hours* Before 2 hours*

In Standby Press anywhere on

Mode screen to view screen

Press anywhere on
screen to view screen Press [EXIT]

Press [EXIT] to exit

standby mode*** Returns user to
last displayed page

* This time amount is user adjustable.

** Possible to start directly if in View Sample,

List Sample, or Main Menu screens.

*** Default automatically runs background count.

If default is inactivated by user, background
count run recommended.

23
3.4 Sample Volume, Throughput, and Parameters

Description The Swelab Alfa is a fully automated cell counter reporting up to 20

parameters.

Sample volume  Auto Sampler: ≤ 300 µl

 Cap Piercer: ≤ 250 µl
 MCI: ≤ 20 µl
 Open Tube: ≤ 110 µl

Throughput  Open Tube: ≥ 60 samples per hour.

 Cap Piercer: ≥ 45 samples per hour.
 Auto Sampler: ≥ 43 samples per hour.

Parameters See list of parameters below:

Leukocyte parameters 20 16 10
WBC Total White Blood Cell Count Yes Yes Yes
LYM% Lymphocytes percentage Yes Yes No
LYM# Lymphocytes (absolute) Yes Yes No
MID% Mid Cell Population percentage Yes Yes No
MID# Mid Cell Population (absolute) Yes Yes No
GRAN% Granulocytes percentage Yes Yes No
GRAN# Granulocytes (absolute) Yes Yes No

Erythrocyte parameters 20 16 10
RBC Total Red Blood Cell Count Yes Yes Yes
HGB Hemoglobin Concentration Yes Yes Yes
HCT Hematocrit Yes Yes Yes
MCV Mean Cell Volume of RBCs Yes Yes Yes
MCH Mean Cell Hemoglobin Yes Yes Yes
Mean Cell Hemoglobin
MCHC Yes Yes Yes
Concentration
Red Blood Cells distribution
RDW% Yes Yes Yes
width percentage
Red Blood Cells distribution
RDWa Yes No No
width (absolute)

Thrombocyte parameters 20 16 10
PLT Total Platelet Count Yes Yes Yes
MPV Mean Platelet Volume Yes Yes Yes
PDW Platelet Distribution Width Yes No No
PCT Platelet Crit Yes No No
Large Platelet Concentration
LPCR Yes No No
Ratio

24
 Section 4: Instrument Setup
Section Overview

Introduction This section covers the initial configuration needed to customize the
instrument settings.

Contents This section contains the following topics:

Topic See Page

Menu Selection 25
Initial Setup 26
Advanced Setup 27
Reagent Setup 31
User Interface 33

4.1 Menu Selection

Main Menu upon  The List Menu will be displayed upon initialization.
initialization  From this main screen all other menus can be accessed for setup.
 By selecting the MENU tab and then pressing [ADVANCED] the
Advanced Menus will be displayed.
List and System
Menu

Figure 4.1 Figure 4.2

25
4.2 Initial Setup

Initial Setup Initial setup of the instrument, except date and time, has been factory set to
default values for the average Boule users. However, other user definable
formats may be preferred, details are provided below.

Setting up The date/time function is shown on all samples and printouts and should
date/time always be setup correctly. To set date/time follow the instruction below:

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP], then press [SETUP MENU 2].
3 Press [DATE/TIME SETUP] to enter the set date/time menu.
4 Press [DATE FORMAT] to select date specific setting.
1 = DD/MM/YY; 2 = YY/MM/DD, 3 = YY/DD/MM, 4 = MM/DD/YY
Press on the item that you want to change and enter the changes on
5
the numerical pad. See Menus below.
Menus

Figure 4.3 Figure 4.4

Activate Mixer
To activate mixer follow the instruction below:
(optional)

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP] and then [SETUP MENU 2].
3 Press [SETUP MENU 3].
4 Press [MIXER].
If the mixer is not activated the button will have empty
5
brackets ( [ ] ). To activate press button and select [X].
Upon sample aspiration mixer will discontinue rotation
Note until sample analysis is complete.
It is recommended that whole blood samples are mixed for
10 – 15 minutes and then analyzed. Mixing for more than
Important 4 hours may cause erroneous results.

Continued on next page

26
4.2 Initial Setup (continued)

Setting up
Change of display language is performed by following the instructions below:
language

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP].
3 Press [SETUP MENU 2].
4 Press [REGIONAL SETUP], a list of local settings will be displayed.
5 Press [MORE] until language button is displayed.
6 Press [LANGUAGE] to enter language screen.
Choose the number that corresponds with the language desired and press [OK]
7
to save.
Menus

Figure 4.5 Figure 4.6

If an option is not available, the number will not be accepted when operator
Note
presses [OK].

4.3 Advanced Setup

Description Initial advanced setup of the analyzer, has been factory set to default values.
However, other user definable formats may be preferred, details on how to
install and configure external components such as barcode readers, printers,
data communication, etc. are provided below.

Default Printer The analyzer has been automatically set to USB printer provided by Boule.
(Printer Type 4)

USB Printer  Contact local distributor for current list of available USB printers
 If using USB printer other than that specified by distributor, the printer
must be HP PCL 5 or IBM proprinter compatible.

27
4.3 Advanced Setup (continued)

Select Printer Follow the instruction below for interfacing analyzer to different printer
Type types. (To connect printer see Section 2.3)

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP] and then [PRINT SETUP] to enter the Print Setup menu.
Press [MORE] to view Printer type. Printer types are as follows:
4 = USB printer
3 5 = Seiko DPU 411/12 and 414
6 = IBM proprinter / Epson compatible
7 = HP PCL 3 and 5 protocol compatible
To change printer type press [PRINTER TYPE], enter the correct number and press
4
[OK] to save.

Print modes To select options for printing results.

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP].
3 Press [PRINT SETUP] to enter the printer setup menu.
To set Manual Print Mode function select from the following:
4
0 = None, 1 = Without Histograms, or 2 = With Histograms.
To select Auto Print Mode function select from the following:
5
0 = None, 1 = Without Histograms, or 2 = With Histograms.
Extended printer format settings and user definable print layouts are also available.
Note Please contact local distributor for further detailed information on how to setup user
definable formats.

Serial Setup To select options for sending results and data follow instruction below:
Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP].
3 Press [SERIAL SETUP] to enter the serial setup menu.
To set Manual Send Mode function select from the following:
4
0 = None, 1 = Without Histograms, or 2 = With Histograms.
To select Auto Send Mode function select from the following:
5
0 = None, 1 = Without Histograms, or 2 = With Histograms.
HW handshake is automatically activated to check serial port connection. To
6
inactivate change [X] to ([ ]), and then [OK] to save.
Send with Ack. is automatically activated to send an acknowledgement message with
7 each sample being transmitted to computer. To inactivate change [X] to ([ ]), and
then [OK] to save
Baud Rate sets the transfer speed on the serial port. The default is 1 (19200N81). To
8
change to slower baud rate, select 2 (9600N81), and then [OK] to save.

28
4.3 Advanced Setup (continued)

Select Serial port sets the output port for sample data, select from the following:
9 2 = USB device port, 3 = USB memory stick, or 4 = USB RS232 serial port
adapter
Select USB vendor and product ID sets the USB identity for the analyzer.
 Select 2 (Boule USB Vendor ID) if your PC application supports the Boule
USB Vendor ID.
10
 If not, select 1 (Gadget Serial USB Vendor ID).
 If unsure, please check the documentation for your PC application, or contact
the company that developed it.

Barcode Setup To setup the barcode reader follow the instructions below. (Note that the
default barcode setting is 9600N81). See barcode reader insert to determine types
of barcodes that can be scanned, if using barcodes for patient IDs.

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP].
3 Press [SETUP MENU 2].
4 Press [BARCODE SETUP] to enter the barcode setup menu.
External For serial barcode readers, set Barcode Reader Type = 1. If not, set it = 0.

To use another USB barcode reader, other than the one delivered by Boule,
together with the instrument, perform the following:
 Leave the barcode reader unconnected.
 Press the button to the right of [Set USB barcode reader].
 The display shows [Connect a USB barcode reader to enable it].
 Connect the USB barcode reader to one of the USB host connectors.
 The instrument returns to [Barcode Reader Setup].
 Check that you can input barcodes with the barcode reader.

Note: If you want to go back to using the USB barcode reader delivered by
Boule together with the instrument, follow the procedure above. The
instrument can only handle one kind of USB barcode reader at a time.
Internal An Internal barcode reader is also available on some models. To change the
factory default setup follow Steps 1-4 and choose the format that is
appropriate. (The Standard Setup is most common.)
0 No internal barcode reader
1 Standard Setup (I2of5 with checksum)
2 I2of5 without checksum
Note If Internal Barcode Reader setting is changed to Setting 1 or 2 press
[INTERNAL BARCODE INITIALIZATION] to re-initialize the barcode
reader.

Continued on next page

29
4.3 Advanced Setup (continued)

Keyboard Setup To setup the keyboard follow manufacturer instruction for setup and plug into
(optional) analyzer keyboard port. See Section 2.3 for details.

Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP], then [SETUP MENU 2].
3 Press [REGIONAL SETUP], and then [MORE].
4 Press [KEYBOARD LAYOUT], and select keyboard type.
5 Press [EXIT] until Main Menu is reached.
6 Turn analyzer OFF, and then turn ON again for changes to take effect.

Data The analyzer is equipped with three different outputs for connection to a
Communication computer (network).
1. USB output with USB device port connector.
2. USB memory stick
3. USB RS232 serial port adapter

USB connection To connect to a PC computer using a USB connector, simply plug in USB
connectors between analyzer and computer, and follow below instructions:
Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP], then [SERIAL SETUP], and then [MORE].
Menus

Figure 4.7 Figure 4.8

To activate the USB connection to a PC computer, press [SELECT SEND
3
PORT] button, then type in [ 2 ], and then [OK] to save.
To activate the USB connection to a memory stick, press [SELECT SEND
4
PORT] button, then type in [ 3 ], and then [OK] to save.
To activate the USB connection to the RS232 serial port adapter, press
5
[SELECT SEND PORT] button, then type in [ 4 ], and then [OK] to save.

Continued on next page

30
4.3 Advanced Setup (continued)

Menu

Figure 4.9
For Select Send Port activation to function correctly user must have
Note
a PC application that can receive and process reports.

To connect to a PC computer using a 9 pin RS232-USB converter see

instructions below:

Cable end converter (9pin) Cable end pc (9pin)

2 3
3 2
5 5
7 8
8 7

4.4 Reagent Setup

Description This section describes the functions of the reagent setup menu and how to
access reagent statistics.

Reagent Input The Swelab Alfa System is interlocked with specified Boule reagents for
(Enter New optimal performance. The reagent containers must be identified by the
Reagents) instrument before analysis of samples can begin. To identify reagents scan in or
manually enter the barcodes on the reagent containers. See section 2.4.

Continued on next page

31
4.4 Reagent Setup (continued)

View Reagent Reagent statistics can be viewed in two ways:

Step Action
1 Start by pressing [REAGENT SETUP] from the MENU tab.
On the lower left-hand side of the Reagent Setup Menu, both the remaining
cycles for Diluent and Lyse are displayed. (It is important to remember that
2
cycles include analyses, wash cycles, background counts, primes, exit
standbys, etc.)

Figure 4.10 Figure 4.11

The second method of viewing reagent statistics is by pressing [VIEW
REAGENTS] from the Reagent Setup Menu. This screen is divided into the
last four Lyse Reagent Statistics and the last four Diluent Reagent Statistics.
For each, the operator can view the following:
 [X] indicates which reagent is currently activated.
 The number of cycles left for specific reagent container.
4
 The Lot and Pack Numbers
 The expiration date of the specific reagent container.
 The Open Date, when the reagent container was first used on the
system.
 The Last Date, when the last time that reagent container was used to
run a cycle.

Inactivate It is possible for the operator to inactivate the current reagent box by pressing
Reagent the [INACTIVATE REAGENT] button and then [YES]. Once deactivated the
operator must scan in or manually enter another reagent container before
analysis of samples can begin. (If reagent level is adequate, an inactive reagent
can be re-activated by simply scanning the barcode on the reagent bottle again.)

Reagent The interlocked reagent system displays indicator and warning messages to
Indicators alert the operator when reagents are running low and need to be changed. See
Section 12.2 and 12.3.

32
4.5 User Interface

Description This section describes the functions of available menus in the instrument that
have not been described in any other section of this manual.

Analysis Profile It shall be possible for authorized operators to customize analysis profiles. See
following menu options:
Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP], then [ANALYSIS PROFILE] to enter the Analysis Profile Setup menu.

Figure 4.12 Figure 4.13

To set profile name press [NAME].
 Press [PREV] or [NEXT] to choose an open profile on list. (e.g. AP8, AP9, etc.)
4  Press [NAME ON DISPLAY] to enter new profile name and press [OK] when complete.
 Press [NAME ON PRINTOUT] to enter new profile name to be displayed on printout and
press [OK] when complete.
Note Remember to [ACTIVATE] the new profile in order to view it as a selection for sample analysis.
5 To set new profile as default press [DEFAULT] and select [X].
To block certain parameters press [BLOCK PARAMETERS] to see list and then [MORE] to
6
view specific parameters. Press any parameter and select [X] to block parameter.
To change RBC/PLT discriminators press [RBC/PLT SETUP] to see list and then [MORE] to
7 view specific discriminators. Press specific discriminator button to change value and then [OK]
to save.
To change WBC discriminators press [WBC SETUP] to see list and then [MORE] to view
8 specific discriminators. Press specific discriminator button to change value and then [OK] to
save.
To change normal ranges press [NORMAL RANGES] to see list and then [MORE] to view
9 specific parameter range. Press specific parameter range button to change value and then [OK] to
save.
Indicative normal ranges are provided in this instrument. It is recommended to establish local
reference ranges (normal ranges) for your laboratory. (See CLSI standard C28-A2 for guidance
Note
on how to establish these ranges and examples of normal ranges in the reference documents listed
at the end of this section.)
New profiles are automatically included in Xb functions and Stats. To not include new profile in
10 Xb functions or Stats press [MISC SETUP] and change [X] to ([ ]), respectively to inactivate
default setting.

Continued on next page

33
4.5 User Interface (continued)

To change background mode setting of the profile press [MISC. SETUP],

choose [BACKGROUND MODE PROFILE] button, choose [X] or [ ] to
11 activate or deactivate, and then [OK] to save. By enabling this setting, the
current profile will behave like the factory default BACKGROUND profile
(i.e. disable AF flagging, disable pathology messages, etc.).
The operator will be prompted to enter a 4-digit Operator ID (Operator ID is
recommended for in-house records but not required) and Authorization Code
Note
(REQUIRED) before a change or update to an analysis profile can be made.
To update or change analysis profiles input the Authorization Code [2576].

Sample Memory The following procedures explain how to search for previous sample analyses
and statistics, and print, send, and delete samples.
Step Action
To view previous analyses at a quick glance press [PREV] or [NEXT] buttons
1
to scroll through samples in either Sample or List menus.
To view a specific sample or a group of samples press [SEARCH] in List
Menu. In this menu samples can be selected by Sample ID, SEQ, Date, and
Sample profile. Press corresponding button to select, and then [EXIT] to
return to List menu and view newly selected samples.

Figure 4.14 Figure 4.15

To return to previous selection criteria either press [SEARCH], then [SELECT ALL],
Note
and then [EXIT] or analyze a new sample.
To view Sample Statistics, select sample or group of samples to view, and
3
press [STATS] to enter the Statistical Results menu.
To print or send selected sample or sample statistics press [PRINT] or
4
[SEND].
To delete selected sample or group of samples press [DELETE]. The
5
instrument will display a prompt to verify deletions, press [YES].

Continued on next page

34
4.5 User Interface (continued)

To print a summary report of every sample run press [SAMPLE REPORT] and then
6 [PRINT ALL SUMMARY REPORT].
To print a summary report of a selected group of samples, select desired criteria (See
7 #2 above), then press [SAMPLE REPORT] and then [PRINT PATIENT
SUMMARY REPORT].
 These summary reports will print on a horizontal sheet of paper.
Note  To print summary reports you can only use HP PCL 3 and 5 protocol compatible
and USB printers.

Menu

Figure 4.16

All Settings From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu.
 To print all instrument settings, verify instrument is connected to a printer and
press [PRINT ALL SETTINGS].
 To send all instrument settings, verify instrument is connected to a computer and
press [SEND ALL SETTINGS].

Change Sequence From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu. To
Number change sequence number press [SEQ NUMBER SETUP], press [NEXT SEQ
NUMBER], enter in new sequence number and press [OK] to save.

Platelet Concentrate Contact local distributor for more information on Platelet Concentrate Mode
Mode activation.

User Definable More detailed Setup Menu descriptions can also be found in the User Definable
Settings Document Settings document, which can be located at www.swelab.com > Support >
Downloads > Public > Documents.

Normal Range 1. Cheng C, Chan J, Cembrowski G, van Assendelft O. Complete Blood Count Reference
References Interval Diagrams Derived from NHANES III: Stratification by Age, Sex, and Race
Laboratory Hematology 10:42-53
2. Nordin G, et al. A multicentre study of reference intervals for haemoglobin, basic blood
cell counts and erythrocyte indices in the adult population of the Nordic countries Scand J
Clin Lab Invest 2004; 64: 385-398
3. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved
Guideline – Second Edition. CLSI C28-A2

35
 Section 5: Sample Analysis
Section Overview

Introduction This section covers the sample analysis routine, including how to analyze a
sample in the five different modes offered in the Swelab Alfa.

Contents This section contains the following topics:

Topic See Page
Preparations before Analysis 36
Startup Sequence 37
Background Count 39
Sample Identification 39
Analyzing the Sample (Open Tube) 40
Analyzing the Sample (Pre-dilution procedure) 42
Analyzing the Sample (Micro Capillary Inlet, MCI) 44
Analyzing the Sample (Cap Piercing Device) 47
Analyzing the Sample (Auto Sampler) 48
Results 52

5.1 Preparations before Analysis

Sample  Human venous blood samples should be collected in an EDTA K3 or EDTA

collection K2 tube in sufficient quantity and be gently mixed immediately after
sampling in order to obtain accurate results. Please follow the
recommendation of the EDTA tube supplier.
 Human capillary blood samples should be collected in either Boule
supplied, plastic, high precision EDTA micropipettes or BD Microtainer®
K2EDTA tubes (or equivalent).

Limitations  Samples drawn in an open tube or vacuum tube should be analyzed within 6
hours for most accurate results.
 Samples drawn into micropipettes should be analyzed within 10 minutes for
most accurate results.

Anticoagulant EDTA K3 (Ethylene Diamine Tetracetic Acid, Tri-potassium) liquid and

recommendation EDTA K2 (Ethylene Diamine Tetracetic Acid, Di-potassium) spray-dried
solution. Recommended by ICSH and NCCLS.

Handling venous  The blood should be allowed to equilibrate to the EDTA for 10-15 minutes
blood samples after sampling.
 The sample should be thoroughly and gently mixed before analysis. It is
recommended to use a mixer.
 The sample should be mixed for 10-15 minutes. A sample not correctly
handled may give erroneous results.
BD and BD Microtainer registered trademarks are the property of Becton, Dickinson and Company

36
5.1 Preparations before Analysis (continued)

Handling of  The sample in the micropipette can be analyzed directly after collection and
capillary blood for optimal results not longer than 10 minutes from collection.
samples  For capillary samples collected in Microtainer tubes follow the “Handling
of venous blood samples” section above.

The sample should be kept at room temperature. Excessive cold or heat could
cause erroneous results.
Important

 As there are no assurances of the absence of HIV, Hepatitis B or C viruses or

other infectious agents in blood samples, blood controls, calibrators and
waste these products should be handled as potentially biohazardous.
Warning  Refer to local regulations and established laboratory protocol for handling
biohazardous materials.

5.2 Startup Sequence

Startup The following sequence guides the operator through the beginning of the day
Sequence startup routine for the analyzer. There are 2 simple steps to follow which takes
the user through a background and control analysis sequence with detailed
guidance at each step. This startup sequence is optional and can be bypassed if a
different startup routine is desired.
Note The startup sequence must be activated to follow this procedure, alternatively
follow the manual background and quality control checks, see 5.3 and 6.1.

Step Action
1 Touch display or switch on power to the analyzer.
2 Press [EXIT STANDBY] or [PWRUP], depending on how the analyzer was shutdown previously.
Enter operator ID and press [OK] or press [CANCEL] to exit Standby. The analyzer will now run
3
a “wake up” sequence.
4 When “wake up” cycle is complete, press start plate to begin the first step of the startup sequence.

Figure 5.1 Figure 5.2

37
5.2 Startup Sequence (continued)

Step Action
When complete the background count results are displayed. If the results are
5 acceptable, scan in the barcode on control vial and follow directions on the
display to begin the second step of the startup sequence.
If the background count results have a H (high) indicator press [RERUN] and follow
Note the screen instructions to analyze background count again.

Figure 5.3 Figure 5.4

When complete the control results are displayed. If control results are acceptable,
press [RERUN] to run next level of control. The startup sequence is complete
6 when all control results are acceptable. Press [ANALYZE SAMPLES] to go to
the main screen, and follow instructions in the following sections to analyze
samples.
If control sample results have a H (high) or L (low) indicator press [RERUN] to
Note
analyze control sample again.

Figure 5.5 Figure 5.6

38
5.3 Background Count

Background The following sequence is performed to check that the background count is low
Check enough to run a sample. It is recommended to run a background check at the
beginning of each shift.

Step Action
1 From the main screen press [NEW SAMPLE].
2 Press [NEXT PROFILE] or [PREV PROFILE] to scroll to Background.
Press the whole blood start plate, which is located behind whole blood
3
aspiration needle. (See Figure 5.7 below)

Figure 5.7
The aspiration time is approximately 10 seconds. After ~ 10 seconds the
instrument will time out due to no detection of blood, and continue its cycle.

Accepted Background The background count should not be higher than the figures shown
values below, assuming that at least 2 “blanks” are run after a sample.

Parameters Values accepted

RBC ≤ 0.02 (1012/ L)
WBC* ≤ 0.1 (109/ L)
HGB ≤ 0.2 (g/ dL)
PLT ≤ 10 (109/ L)
*The micropipette inlets are acceptable at WBC ≤ 0.2 (109/ L) due to
potential pre-analytical contributions.

5.4 Sample Identification

Description This section describes the different methods of inputting Sample IDs
(Identification). There are two (2) ID Fields available.

ID Input The ID can be entered with the following methods:

Methods  Manually (touch screen or external keyboard)
 Barcode (Barcode entry is limited to ID 1 only)

Character Input A maximum of 16 Characters (alpha and numeric) are allowed in both ID 1
Limitations and ID 2 fields.

Continued on next page

39
5.4 Sample Identification (continued)

Step Action
From the main screen press [NEW SAMPLE] or begin sample
1
aspiration, which automatically opens NEW SAMPLE menu.
Press numerical keys to enter sample ID or scan in the ID barcode
2
from the sample tube. Press sample ID2 if a second ID is needed.
Press [NEXT PROFILE] or [PREV PROFILE] to scroll to desired
3
profile.
Press [OK] to save profile and sample ID or begin sample
4
aspiration.
Menu

Figure 5.8 Figure 5.9

5 Aspirate sample following selected procedures in sections 5.5 – 5.9.
Sample ID entry and profile selection can be performed up to 30
Note
seconds after sample aspiration.

Operator ID The Operator ID is an optional feature which can be entered prior to analyzing
a sample or when exiting Standby Mode. To enter an Operator ID press the
specified button and enter up to a 4-digit numerical or alphabetic ID. The
Operator ID will stay the same until Operator ID button is pressed again and
changed, or when the analyzer goes into Standby Mode.

5.5 Analyzing the Sample (Open Tube)

Description This section describes how to aspirate and analyze a sample with the “Open
Tube” procedure.

Starting Refer to Section 5.1 for blood sample preparation and then follow the
procedure procedure below:

Continued on next page

40
5.5 Analyzing the Sample (Open Tube) (continued)

Step Action
Choose List, Sample, or Main menu to begin sample analysis.
1
Analyzer must be in one of these operation modes to aspirate.
Aspirate the sample through the aspiration needle by gently inserting
2 aspiration needle into the sample tube, and then press the whole blood
start plate behind the left aspiration needle. (See Figure 5.10)
Follow the instruction on the menu when to remove the sample tube.
3
A beep should be heard indicating sample removal.
 Make sure that the blood sample tube is not touching the upper part of the
aspiration needle.
 Not removing the sample tube could result in incorrect washing sequence of
the aspiration needle.
Important
 Do not remove sample prior to instruction, incomplete aspiration could
occur, causing erroneous results.
Sample Aspiration

Figure 5.10
 As there are no assurances of the absence of HIV, Hepatitis B or C viruses or
other infectious agents in blood samples, controls, and calibrators these
products should be handled as potentially biohazardous.
Warning  Refer to local regulations and established laboratory protocol for handling
biohazardous materials.
Sample Aspiration Display

Figure 5.11 Figure 5.12

41
5.5 Analyzing the Sample (Open Tube) (continued)

The instrument now switches to the sample analysis screen.

Figure 5.13 Figure 5.14

7 In first screen displayed above Sample ID and profile can still be added.
Approximately 30 seconds after aspiration the display switches to that in
8
Figure 5.14 and no further ID entry is possible.
After 45 seconds results will be displayed on List or Sample menu. For more
9
information of results refer to Section 5.10.
When NEW SAMPLE button returns to green, operator can begin analysis of
10
next sample.

5.6 Analyzing the Sample (Pre-dilution procedure)

Description This section describes how to analyze a pre-diluted sample through the “pre-
dilute” aspiration needle and how to use the dispense function. There are two
ways of pre-diluting a sample. The recommended pre-dilute method is using
the dispense function, which uses the factory calibrated dilution ratio of 1:225
(20 µl sample in 4.5 ml diluent). The second method is performing an external
pre-dilution using in-house dilution procedures, dilution ratios between 1:200
– 1:300, and re-calibrating system using selected dilution ratio.

Dilution Rates Dilution Rates: 1:200 – 1:300

and Ratios Recommended: 1:225 (20 µl sample in 4.5 ml diluent)

Continued on next page

42
5.6 Analyzing the Sample (Pre-dilute procedure) (continued)

Time limitations Pre-dilute procedures are generally less precise than open and closed tube
procedures and results may vary depending on local laboratory procedures and
conditions. Blood cells may shrink and/or swell during the time between mixing
in the beaker and the actual analysis, resulting in compromised values of MCV,
MPV and the distribution between lymphocytes/mid-cells/ granulocytes (with
indirect effect on calculated parameters, e.g. HCT). Thus, the time between
mixing and analysis should be minimized and under no circumstances exceed 60
minutes, since RBC, PLT, HGB and WBC may also be affected.

Externally Pre-  Pre-dilute volumes 4.5ml – 5.0ml. The dilution ratio must always be the same
diluted volumes as the dilution it is calibrated to in order to avoid erroneous result; any dilution
and preparation variation in an externally diluted sample will affect the parameter test results.
 Prepare pre-dilute sample according to internal documentation and time
limitations section above.
Note In order to get accurate results always use the same dispenser for calibration and
sample analysis.

Dispense  This feature is to be used as a precision dispenser for dilution of blood samples.
Function  Dispense amount: 4.5 ml.
 Dilution: 20 µl sample in 4.5 ml diluent (1:225)
 Follow the instruction below:
Step Action
1 Press the [DISPENSE] button from the MENU tab.
Before pressing the pre-dilute start plate make sure that a waste beaker is placed under the
2
pre-dilute aspiration needle.
Press the pre-dilute start plate (right-side start plate) to enable dispense mode. (The
3 instrument will fill the waste beaker with a small amount of diluent, this is to be
discarded)
Fill the pre-dilute beaker by pressing the start plate again. If more than one beaker is to be
4
filled repeat this step.

Menus

Figure 5.15 Figure 5.16

Prepare pre-dilute sample according to internal documentation and time limitations
5
section above.
To re-enter analyze mode press [CANCEL] and follow instructions below to analyze pre-
6
dilute samples.

43
5.6 Analyzing the Sample (Pre-dilute procedure) (continued)

Pre-dilute
Start by selecting pre-diluted sample beaker and follow the procedure below:
procedure
Step Action
Choose List, Sample, or Main menu to begin sample analysis. Analyzer must
1
be in one of these operation modes to aspirate.
Aspirate the pre-diluted sample through the pre-dilute aspiration needle by
2 pressing and holding the pre-dilute start plate behind the right-side aspiration
needle until aspiration starts. (See Figure 5.11)

Figure 5.17
Follow the instruction on the menu when to remove the sample tube. A beep
3
should be heard indicating sample removal.
4 Refer to Section 5.5 Steps 5 - 10 for remainder of analysis sequence.

Do not analyze a whole blood sample in the pre-dilute mode, this will cause
erroneous results. If this happens following the instructions below, as soon as
possible, to return analyzer to normal operation status:
1. Use dispense mode to dispense diluent into waste beaker until diluent has
no traces of blood left. Then dispense two more times and discard waste.
Important 2. Next, dispense clean diluent into beaker and run diluent in pre-dilute mode.
3. Check background results. If results pass, instrument is now ready to use. If
results do not pass, repeat step 2 until background results pass.

5.7 Analyzing the Sample (Micro Capillary Inlet, MCI)

Description This section describes how to analyze capillary whole blood samples with the
use of the Micro Capillary Inlet (MCI).

Micropipettes ONLY Boule supplied, plastic, high precision EDTA micropipettes should be
used when running MCI. Glass micropipettes can cause damage to instrument
if inserted incorrectly.

Lancets Recommended to use BD Microtainer® Contact-Activated Lancet, Blue,

Recommendation High flow, 2.0 mm x 1.5 mm (e.g. Article number 366594).
Continued on next page
BD and BD Microtainer registered trademarks are the property of Becton, Dickinson and Company

44
5.7 Analyzing the Sample (Micro Capillary Inlet, MCI) (continued)
Collection Samples can be analyzed using the MCI from both venous and capillary blood
methodology specimens.
 For venous collection, see Section 5.1 and steps at the end of this section for details
of sample handling and preparation.
 For capillary collection, follow steps below and the procedure for optimal collection
of capillary blood specimens given in the CSLI standard H04-A6 "Procedures and
devices for the collection of diagnostic capillary blood specimens". (For latest edition
of this standard go to www.clsi.org.)

Starting procedure Follow the procedure below to operate MCI:

Step Action
Choose List, Sample, or Main menu to begin sample analysis. Analyzer must be in one
1
of these operation modes to aspirate.
Pull out the MCI adapter. (The instrument will give an instruction to put back the MCI
2
adapter to start).
3 Remove the previous sample micropipette. (If applicable)
4 Place the adapter on the table.

Puncture site preparation for capillary blood collection

Step Action
Choose site for skin puncture. (See CLSI standard for details on recommended site for
5
finger and heel punctures.)
Warm the skin site for 3 -5 minutes before puncture to increase blood flow to the site
6
(arterialization). This can be done using a warm, moist towel or other warming device.
Cleanse site with 70% aqueous solution of isopropanol or appropriate disinfectant. Allow
7
the skin to dry before puncture.

 Due to PLT adhesion to tissue and capillary walls and imprecision in preparation and
blood draw procedures, discrepancies between capillary and venous blood values
may occur on the following parameters:
o PLT may be lower in capillary blood by 5-10%
Important o WBC may be slightly elevated if PLT clumping occurs
 See “Reference Literature: Capillary vs Venous Blood Sampling” on Boule website
for further details.

Drawing blood and sample preparation:

Step Action
Follow lancet packaging insert for instructions on proper use. Puncture middle or ring
finger, using the lancet.

Figure 5.18

45
5.7 Analyzing the Sample (Micro Capillary Inlet, MCI) (continued)
Step Action
Always use gloves when in contact with potentially biohazardous materials.
After puncture, wipe away the first drop of blood with a clean tissue or
Warning 9
gauze pad. (First drop of blood often contains excess tissue fluid.)
When second drop forms, aspirate the sample as shown below, being
careful to only allow the tip of the micropipette to touch the drop of blood
(not the finger directly).

10

Figure 5.19
By holding puncture site downwards and applying gentle, intermittent
pressure above the site, the blood flow will be enhanced. Do not use
Note scooping motion or strong repetitive pressure, “milking”, to the site. (This
can cause hemolysis or contaminate sample with excess tissue fluid.)
 Fill the micropipette completely with fresh whole blood and wipe off excessive
blood on the outside surface.
Important
 Be careful not to wick blood from open ends of the micropipette.
 Ignoring these instructions might cause incorrect and non-reproducible results.
Insert the micropipette into the MCI device as shown below:

11

Figure 5.20
Insert the MCI into its holder and the instrument will automatically start
the analyzing sequence.

12

Figure 5.21
Do not remove MCI during sample aspiration or analysis. Removal prior to
completion of analysis may cause erroneous results.
13 Refer to Section 5.5 Steps 6 - 10 for remainder of analysis sequence.
Important

46
5.7 Analyzing the Sample (Micro Capillary Inlet, MCI) (continued)

Venous collection sample preparation

Step Action
1 Follow sample preparation in Section 5.1.
Use the micropipette holder to grasp a micropipette. (Holding the
2 micropipette towards one end or the other, instead of in the middle, is best
for filling and insertion.)
Tilt sample vial at a 45 degree angle until blood is near the lip of the vial, but
3
does not overflow.
Place one end of micropipette in blood column and aspirate blood until
4
entire micropipette if filled. (This filling process uses capillary action.)
Remove micropipette from vial and wipe off excessive blood on the outside
5
surface being careful not to wick blood from open ends of the micropipette.
6 Follow steps 11 – 13 above to analyze sample.

5.8 Analyzing the Sample (Cap Piercing Device)

Description This section describes how to analyze whole blood samples using the Cap
Piercing Device.

Sample tube Most standard 3.0 ml to 5.0 ml tubes, with a maximum length of 82 mm, can
description be used in the cap piercing device. The minimum volume in the closed tube
should be approximately 1 ml.

The Cap Piercer can be damaged if incorrect sized tube is used.

Caution

Starting procedure Follow the procedure below to operate the Cap Piercing Device.

Step Action
Choose List, Sample, or Main menu to begin sample analysis. Analyzer must
1
be in one of these operation modes to aspirate.
Open door to cap piercer and insert vacuum tube upside down, pressing the
2
tube in place, aligning with lower support.

Continued on next page

47
5.8 Analyzing the Sample (Cap Piercing Device) (continued)

Step Action

Figure 5.22 Figure 5.23

 Always use gloves when in contact with potentially biohazardous materials.
 Caution should be applied when handling the cap piercer. Handling and operation
by unauthorized personnel may result in injury.
 Insert the sample tube with lid facing downwards. Ignoring this instruction may
Warning damage the aspiration needle.
4 Close the door to the cap piercer to begin sample analysis.
5 Refer to Section 5.5 Steps 6 - 10 for remainder of analysis sequence.

5.9 Analyzing the Sample (Auto Sampler)

Description This section describes how to analyze whole blood samples using the Auto
Sampler (Sampling Device).

Sample tube Only standard 4.0 to 5.0 ml tubes can be used in the Sampling Device. A
description sample wheel adapted for Sarstedt tubes is available as an option. The
minimum volume in the closed tube should be approximately 1 ml.

Selecting Sample ID There are several ways to select the samples.

Step Action
The Sampling Device has a mounted internal barcode reader. If a barcode is used for
the ID number, the operator can simply place the tube in sample wheel and the ID
1
number will be read automatically. It is very important to line up barcode on tube with
barcode reader.
Another option is to manually enter in ID numbers, using the external barcode reader or
the touch screen keyboard.
 To manually enter ID number press [SAMPLING DEVICE] and then [INPUT ID].
2  Then either scan in ID number with external barcode reader or press [INPUT ID],
type in desired ID number, and then press [OK] to accept.
 After ID number is entered the next position for entry will automatically be
highlighted.

Continued on next page

48
5.9 Analyzing the Sample (Auto Sampler) (continued)

Step Action

Figure 5.24
Samples can also be analyzed without identification, but then only the
3
sequence numbers will be present on the worklist.

Selecting Profile Type To select a different profile type for a sample press [SET PROFILE
TYPE] in Sampling Device ID Input display, select desired profile, and
then press [OK].

Editing Sample ID Changing a sample ID number or position must be performed prior to

Number pressing [START] on Sampling Device List display.
Step Action
1 Press [SAMPLING DEVICE] and then [INPUT ID].
2 Press [NEXT] or [PREVIOUS] to scroll to corresponding ID number.
Manually enter in new ID number, using the external barcode reader or the
3
touch screen keyboard.

Wheel Selection When numerous samples are being analyzed an additional wheel may be
needed. Additional wheel entry can begin before or after previous wheel
has begun analysis.
Step Action
Press [WHEEL], on Sampling Device ID Input display, until position
1 numbers on display match the position numbers on the wheel the operator
is currently loading with new samples.
2 Follow steps 1-3 on Selecting Sample ID.
Wait for previous wheel to finish before placing new wheel on front
3 position of analyzer. Previous wheel is finished when [SAMPLING
DEVICE] button is highlighted green.

49
5.9 Analyzing the Sample (Auto Sampler) (continued)

Emergency Emergency (STAT) samples can be analyzed after the Sampling Device has
Sample Analysis been started or during Sampling Device ID entry. There are several ways to
analyze an emergency sample.
Step Action
Emergency sample can be analyzed through OT, pre-dilute, or MCI mode.
 Press [PAUSE], wait for [NEW SAMPLE] button to highlight green, and then
analyze sample in preferred mode.
 There may be a slight delay after pressing [PAUSE] button before emergency
1 sample can be analyzed. This is because analyzer will complete the counting cycle
of the last sample run on sample wheel before continuing with emergency sample
analysis.
 When emergency sample is complete, press [CONTINUE] to restart sampling in
next position on the wheel.
Emergency sample can also be analyzed using the sample wheel.
 Press [STOP], unlock sample wheel and place emergency sample in Position 1 or
21.
 If a sample is already occupying Position 1 or 21 and has already been analyzed,
remove sample and place emergency sample in its place.
2  If emergency sample has a barcode for ID number, align barcode correctly, lock
sample wheel and press [CONTINUE].
 See Editing Sample ID number is manual entry of sample is desired, and lock
sample wheel and press [CONTINUE].
 Analyzer will automatically analyze emergency sample and then continue
sampling where it left off prior to pressing [STOP] button.
DO NOT press [START] after sampling device has been paused or stopped unless
Note
operator wants to rerun all samples on wheel.

Control Sample If analyzing samples using the Auto Sampler mode it is recommended to also
Analysis run daily control samples using the sample wheel.

Step Action
1 Follow instruction in Section 6 for control handling and assay sheet input.
2 Firmly press capped end of control sample into control tube adapter.
Load the control sample by placing the adapter towards the outer edge of the sample
wheel and fitting it into Position 1 for all tubes except Sarstedt. Place Sarstedt control
sample in Position 40.
3
 Position control tube barcode facing TOWARDS analyzer and centered in slot.
 If using all three levels of control, add adapters to all levels of controls and fit
them into Positions 1, 2, and 3.
4 Following instruction below for Starting Sampling Device.

50
 5.9 Analyzing the Sample (Auto Sampler) (continued)

Starting Sampling Device Follow the procedure below to operate the Sampling Device.
Step Action
Unlock the center piece by turning it counterclockwise and lightly pulling it away
1
from analyzer.
Load the vacuum tube samples by placing the capped end towards outer edge of
sample wheel and fitting it into designated slot. (The first positions of sample
2
wheel (example: Position 1 and 21) are recommended to be left open for
emergency samples.)
It is important that tubes are positioned correctly.
 Position tubes with barcodes facing TOWARDS analyzer and centered in slot.
Note
 Position tubes without barcodes so that label on tube is facing AWAY from
analyzer.
3 Lock in samples by turning center piece clockwise.
4 Press [SAMPLING DEVICE] button from the List, Sample, or Main menu.
Press [START] to immediately begin analysis or press [EXTRA MIX] if extra
mixing of samples is needed. Default mix setting = 10 minutes. (Extra mixing can
5 be set from 1 to 15 minutes in Setup Menu 3 by choosing [MIXER SETUP] and
then [SET MIXING TIME (SAMPLER)].
 Do not touch sample wheels or samples during operation.
 Handling and operation by unauthorized personnel may result in injury.
Warning Sampling Device begins analysis with the sample tube placed in the lowest
6
position number.

Figure 5.25 Figure 5.26

Sample Status (St.), SEQ, and ID number will appear in Sampling Device List as
7
they are analyzed.
Sample Status has three columns:
 Column 1 is sample tube detection: (+) = Detected, (-) = Not detected, (?) =
Not yet determined.
8
 Column 2 is first analysis: (+) = Complete, (-) = Aspiration Failure, (!) =
System Information Message, (0) = No Sample in tube.
 Column 3 is Re-analysis: same as Column 2 except re-analysis is not repeated.
Press [EXIT] to view sample results. [NEXT] button will highlight when the next
9 sample being run is complete. For more information of results refer to Section
5.10.

51
5.10 Results

Description This section describes the information that can be obtained from the sample
analysis results.

After sample After a sample has been analyzed the result information can be viewed in the
analyze following three screen displays:

Sample View 1
WBC histogram
Total WBC count and
differential values

HGB parameters
RBC histogram

Total RBC count and

RBC parameters
PLT histogram

PLT count and PLT parameters

Figure 5.27

Sample View 2

Sample IDs Analysis mode and

analysis profile

Primary Diagnostic
Parameters

Operator ID
Displays date and time of
sample analysis, and WBC
and RBC counting times.

Press on to view
different views of
same sample.
Use these buttons to scroll to
previous and next samples.

Figure 5.28

Continued on next page

52
5.10 Results (continued)

Sample View 3

Normal Range display

with sample results.
Sample results

Green bar = Results within Range

Information Indicator – When

highlighted user can press
button to display system
information messages.

Red bar = Results Out-of-Range

Press to print current

sample analysis.
Figure 5.29

53
 Section 6: Quality Control (QC) and Blood
Control Memory
Section Overview

Introduction The Swelab Alfa is equipped with a QC memory capable of displaying and
printing Xb and Levey Jennings plots.

Contents This section contains the following topics:

Topic See Page

Quality Control (QC) 54
Levey-Jennings Plots 57
Initialization and Use of Xb Function 58

6.1 Quality Control (QC)

Introduction This section describes the procedures to be performed for running control
samples.

QC Menu and Follow the instruction below to access the QC menu and to input
Assay Value Control/Calibrator Assay Values from the Assay sheet.
Input

Step Action
1 Enter the QC menu by pressing [QC] from the menu tab.
2 Press [ENTER CON/CAL].
Refer to the Assay sheet for instructions on how to input Assay Values. (These pages
are delivered with authorized Boule controls).

Figure 6.1 Figure 6.2

12 different Assay Lots from Boule can be stored simultaneously.
Note When entering a new Assay Lot, the previously scanned Assay Lot will be removed in
a chronological order starting with the first entered Lot.

54
6.1 Quality Control (QC) (continued)

Control Analysis It is advisable that the performance of the Swelab Alfa system is checked daily
with a certified blood control authorized by Boule. For good laboratory
practice controls may also be used for troubleshooting purposes and when
changing to a new lot of reagents, to check for damage during transport or
storage. Comparing the analyzer results to the known values on the Boule
control assay sheet is a good assurance that the system is functioning properly.

 Handle and prepare controls in accordance to control package insert.

 Never use an open vial longer than recommended by the manufacturer or
subject any vial to excessive heat or agitation.
Important  Wipe the aspiration needle with a clean, dry lint free absorbent cloth before
each control run. Not following this technique will impact control accuracy.

 As there are no assurances of the absence of HIV, Hepatitis B or C viruses

or other infectious agents in blood samples, controls, and calibrators these
products should be handled as potentially biohazardous.
Warning  Refer to local regulations and established laboratory protocol for handling
biohazardous materials.

Step Action
1 Follow directions on Assay Sheet to scan in assay values.
Choose either List, Sample, or Main Menu to begin control
2
analysis.
Using installed barcode reader, scan the Control ID from the blood
3 control vial label or manually enter in barcode.
Aspirate the blood control and wait for the results. The Swelab
4 Alfa will identify this ID and match the results with the previously
defined control assay values.

Search Function Each blood control type can be found by control lot number, level, date or
sequence number.

Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
2 Input the search criteria to be used.
Pressing on the SEQ bar will display Figure 6.4, in which one
3
particular lot or level can be selected.

Continued on next page

55
6.1 Quality Control (QC) (continued)

Menus

Figure 6.3 Figure 6.4

4 Press the [SAMPLE] or [LIST] buttons to display the selected samples.
Once samples are displayed they can also be printed out in a Monthly QC
summary report.
 After the control lot (profile) has been selected the Monthly QC
button will become active.
5
 Press [MONTHLY QC] button, use the [PREV] and [NEXT] buttons
to scroll to desired month, and press [EXIT].
 The Monthly QC button will turn green when lot and month have
been chosen. Press [REPORT] button to print out report.

Menus

Figure 6.5 Figure 6.6

To exclude a sample from the Monthly QC or LJ Diagram summary
reports perform the following steps prior to Step 5 above:
 Scroll to the control sample to be excluded using the [PREV] and
[NEXT] buttons in the Con/Cal Sample or List tabs.
6
 Then press [EXCLUDE/INCLUDE] button. An “X” will be placed
next to excluded sample.
 To include the sample press the [EXCLUDE/INCLUDE] button
again.

56
6.2 Levey-Jennings Plots
Procedure This section describes selecting, viewing, and printing Levey-Jennings Plots.
instruction

L-J Plots Levey-Jennings (L-J) plots are used to monitor the long term stability of the
instrument using Boule blood controls.

Controls To be able to use L-J plots, the Control/Calibrator Assay Values for the
blood controls, must be scanned with the installed barcode reader or
manually entered in. Follow direction on Assay Sheet to scan in assay
values.

Displaying and
To display and print the L-J plots, follow the instructions below:
printing L-J Plots
Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
Scan the barcode label on the blood control tube, with the barcode reader, select
2
control from Select Con/Cal Sample Menu, or manually enter in value.
3 Press [L-J VIEW] to display the Levey - Jennings plots.
4 Scroll through parameters by choosing [MORE].
5 Print diagrams by choosing [PRINT].
L-J plot Image 6.7 below is constructed from several samples and will not be shown as
Diagram below until a sufficient amount of samples have been analyzed.
s

Figure 6.7 Figure 6.8

6 A Monthly QC L-J Diagram report can also be viewed and printed:
 Follow Steps 5 -6 in Section 6.1 to select control lot and month.
 Press [L-J VIEW] to view the monthly diagrams. The Monthly L-J diagrams
will differ from the normal L-J plots as the x-axis uses the expected range for
its out-of-bounds criteria and on the y-axis the points can be visibly traced to
which day of the month it was analyzed on.
 To print the diagrams on the displayed page, press [PRINT] or to print all
diagrams, scroll to the last display page without plots and press [PRINT].

Continued on next page

57
6.2 Levey-Jennings Plots (continued)

Parameters
The L-J plots are displayed for all parameters defined in the Assay Sheet
displayed on
L-J Plots
except the WBC differential parameter “MID”.

Note If a control shows a system information indicator, the parameter values of such a
control will not be included in the L-J plots.

6.3 Initialization and Use of Xb Function

Description The Xb function in the Swelab Alfa follows strictly the Bull algorithm for the
parameters MCV, MCH and MCHC. These parameters should not drift as a
function of time within a large patient population. The recommended range
setting is ± 3% from the expected mean value of these parameters.

Step Action
1 Enter the QC menu and press [VIEW Xb STATS].
2 Select Xb points by Date or by default all sample data is selected.
3 Press [LJ VIEW] to display Xb L – J diagrams.
Xb L-J The image below is constructed from several samples and will not be shown
Diagrams as below until a sufficient amount of samples have been analyzed.

Figure 6.9 Figure 6.10

4 Select [MORE] to view selected conditions and matched ranges.
5 Print diagrams by choosing [PRINT].
To change ranges on Xb Diagrams go to Setup Menu 3 and press [XB
RANGE SETUP]. Here operator can change low and high ranges on the
6
three parameters. To update or change Xb range setup input the Authorization
Code [2576].

Reference Bull BS, Hay KL. The blood count, its quality control and related methods: X-bar calibration
and control of the multichannel hematology analysers. In: Clangoring I. editor. Laboratory
Hematology: An account of Laboratory Techniques. Edinburgh.

58
 Section 7: Calibration
Section Overview
Introduction This section describes the step-by-step procedure for calibration of the Swelab
Alfa. The instrument has been calibrated by Boule prior to shipment. Good
laboratory practice, however, requires regular checks and calibration of the
measured parameters

Contents This section contains the following topics:

Topic See Page
Preparations before calibration 59
Calibration 60

7.1 Preparations before calibration

Before  It is advisable that the performance of the Swelab Alfa system is checked
Calibration daily with a certified blood control authorized by Boule.
 Analyze control blood once in the open tube mode and compare results with
the assigned values prior to calibration.
 Before recalibration of the instrument check that calibrator and reagents are
not outdated and exclude instrument failure.
 Verify that instrument maintenance/cleaning is current. (See Sections 8.1 –
8.3)
 Prior to calibration print Calibration Log. Select [ADVANCED] from Main
Menu, then [CALIBRATION], then [CALIBRATION LOG], and then
[PRINT].

 The user should be thoroughly familiar with the analyzer system and the
calibration procedure before performing calibration.
 Refer to the Calibrator Product Insert for complete instructions for handling
and use of blood calibration materials.
 Never use an open vial longer than recommended by the manufacturer or
Important subject any vial to excessive heat or agitation.
 Wipe the aspiration needle with a clean, dry lint free absorbent cloth before
each calibrator run. Not following this technique will impact control
accuracy.

 As there are no assurances of the absence of HIV, Hepatitis B or C viruses

or other infectious agents in blood samples, controls, and calibrators these
products should be handled as potentially biohazardous.
Warning  Refer to local regulations and established laboratory protocol for handling
biohazardous materials.

59
 7.2 Calibration
Input Calibrator Follow the instruction in Section 6.1 Quality Control to access the QC menu and
Assay Values to input Control/Calibrator Assay Values from the Assay sheet.

Whole Blood The following instructions calibrate Open Tube, Cap Piercer, and Sampling
Calibration Device modes. Follow the instructions below to calibrate:
Step Action
1 Follow directions on Assay Sheet to scan in calibrator assay values.
2 Choose either List, Sample, or Main menu to begin calibrator analysis.
Using installed barcode reader, scan the Calibrator ID from the calibrator
3
vial label.
To perform calibration, it is recommended that five calibration analyses
4
be performed in consecutive order through the open tube mode.
Note DO NOT use Cap Piercer or Autoloader mode to aspirate calibrator.
Important 5 When analyses are complete press [ADVANCED] from the MENU tab.
Press [CALIBRATION] and then choose [WHOLE BLOOD].

Figure 7.1 Figure 7.2

Calibration analysis must be last analysis performed on instrument for
parameter values to be shown in calibration menus. (e.g. no values will
Note
show if in the middle of calibration a patient sample analysis was
performed)
Scroll through parameter screens by using the [NEXT] button and verify
that the CVs for the following parameters are within the stated limits:
Parameter OT/CT CV% MCI/PD CV%
RBC < 2.2 < 3.2
MCV < 1.8 < 1.8
7 PLT < 5.8 < 6.2
HGB < 1.8 < 2.9
WBC < 4.2 < 4.8
MPV < 4.0 < 4.0
*CV limits are wider on the MCI/Pre-dilute calibration due to differences
in pipetting and blood collection techniques at the operator level.

60
7.2 Calibration (continued)

If CV values are not within range operator will be unable to perform calibration.
(Analyses with system information indicators will automatically inactivate that
analysis from the CV calculation and depending on flag may not be stored on
8
list at all.) If a known sample handling error or erroneous result is present, then
sample can be inactivated by pressing button to the left of that particular analysis
and changing to empty brackets [ ].
If all parameters have acceptable CVs proceed to next step, if not rerun
9
calibration following steps above.
The new calibration factor can be entered in three ways.
 The recommended method is to select the [USE CAL] button which will
automatically calculated the new calibration factor using target range from
assay values.
 The second method, if no calibrator is available, is to perform Steps 4-9 using
a sample with target values from an assay sheet or determining target values
10
using a reference analyzer or a microscope method with an in-house sample.
The target values can be entered selecting the [SET TARGET VALUE]
button and manually entering in the values.
 The third method is to manually calculate and enter in calibration factor. This
method should only be used with instruction from local distributor or
authorized service technician.
In the first and second methods the calibration factor is automatically calculated
11
once either the [USE CAL] button is pressed or target value is entered.
Once calibration factor has been entered using one of the methods above,
operator will be prompted to enter a 4-digit Operator ID (Operator ID is
12 recommended for in-house records of calibration operator but not required) and
an Authorization Code (REQUIRED) before the new value can be changed or
updated.
Authorization Code prompt is displayed only once per calibration sequence
Note when [USE CAL], [TARGET VALUE], or [NEW CAL FACTOR] buttons are
pressed
Authorized operator can update or change calibration factor by inputting the
Authorization Code [2576].

13

Figure 7.3
Continued on next page

61
7.2 Calibration (continued)

Perform steps 9-12 for RBC, MCV, PLT, HGB, MPV and WBC parameters. To
14
move to the next parameter press [NEXT].
It is recommended to not change preset calibration factors for RDW%, RDWa,
15 and PDW. If necessary, please contact local distributor or Boule service
technician for procedure.
Once parameters are calibrated, press [EXIT] and a screen will be displayed
asking operator if a calibration report is wanted, [SEND], [PRINT], or [EXIT]
can be selected. It is recommended that calibration reports be printed and
archived in case it may be needed for future reference.

16

Figure 7.4
It is recommended to run controls after calibration to verify that all parameters
17
have been calibrated correctly. See section 6.1 to perform QC.

Capillary Device To calibrate MCI follow Steps 1-17 above except select [CALIBRATION] and
Calibration then choose [CAPILLARY DEVICE] instead of Whole Blood calibration in
Step 6 and use MCI mode for analysis. (See Section 5.7 for details on capillary
device sample analysis.)

Pre-dilute To calibrate pre-dilute follow Steps 1-17 above except select

Calibration [CALIBRATION] and then choose [PREDILUTE] instead of Whole Blood
calibration in Step 6 and use pre-dilute mode for analysis. (See Section 5.6 for
details on pre-dilute sample analysis.)

Cap Piercing The closed tube device is calibrated with the calibration of the Open Tube inlet.
Device However, if the same systematic differences are seen on RBC, HGB, WBC,
Calibration and PLT when analyzing blood in the closed tube device compared to the open
tube, a calibration factor can be calculated. This method should only be used
with instruction from local distributor or authorized service technician.
Note DO NOT use Cap Piercer mode to aspirate calibrator.

62
 Section 8: Cleaning, Maintenance & Transport
Section Overview

Introduction This section contains information that is crucial for maintaining, transporting
and storing the Swelab Alfa.

Contents This section contains the following topics.

Topic See Page

Daily Cleaning 63
Monthly Cleaning 64
Six (6) Month Cleaning 65
Instrument Maintenance 65
Re-location of instrument (within the laboratory) 66
Short Term Shutdown (<12h) 66
Re-packaging and Long Term Transport 67
Permanent Shut-Down and Storage 68
Disposal Information 68

8.1 Daily Cleaning

Description The majority of the instruments cleaning procedures are automated to keep the
user maintenance to an absolute minimum.

Always use gloves when in contact with potentially biohazardous materials or

parts of the instrument that might be contaminated with blood.
Warning

Cleaning
The Daily Cleaning takes only a few minutes, the instructions are as follows:
Procedure

Step Action
Clean the aspiration and pre-dilute needles using a paper tissue with
1
a 70% alcohol solution.
Remove possible traces of salt crystals or blood at the top of the
aspiration and pre-dilute needles, probe rinse cup, and around top of
2
sampling device needle inlet (if applicable) using a paper lint free
absorbent cloth with a disinfecting solution.

63
8.2 Monthly Cleaning
Description This section describes the cleaning procedure to be used to secure the correct
function of the instrument on a monthly basis.

Cleaning The Monthly Cleaning procedure takes approximately 10 minutes, instructions

procedure are as follows:
Step Action
1 Clean the aspiration needles using a paper tissue with a 70% alcohol solution.
Fill a cup with 10 ml 2% hypochlorite (bleach), certified by Boule, and one cup with 18 ml
2 diluent. (Recommend use of dispense function for obtaining diluent, see Section 5.5:
Dispense Function.)
3 Aspirate the hypochlorite as a pre-diluted sample.
4 Run 2 blank samples by aspirating diluent as a pre-dilute sample.
Perform a background check, in pre-dilute mode, to verify all values are within range. See
5
Section 5.3 for more details.

Clot Prevention This process will decrease the risk of debris material building up in the
instrument system. This should be performed at least once a month or every
1000 samples. This procedure will take 15 minutes to complete.

 Once this procedure is started the operator will be unable to abort the cycle
until it is completed.
 Prematurely aborted the cycle could cause erroneous patient results if system
Important is not cleaned properly.

Step Action
Fill a small container with 5 ml of Enzymatic Cleaner. (Enzymatic Cleaner from the
1
cleaning kit can be used.)
If system has the optional Cap Piercer or Sampling Device, fill a CLEAN standard 4.0 – 5.0
Note
ml tube half full with Enzymatic Cleaner.
From Main Menu press [ADVANCED], then [MAINTENANCE] and then press [CLOT
2
PREVENTION].
 For Cap Piercer: Place filled cleaner tube into cap piercer, same as a normal sample
analysis, close the door, and go to Step 4.
3
 For Sampling Device: Place filled cleaner tube into Position 1 on wheel, lock wheel into
place, and go to Step 4.
Hold the container (with cleaner) under the OT needle, submerged in cleaner, press [OK] to
confirm. Do not remove container (with cleaner) for at least 5 seconds after aspiration has
4
stopped. (This is important as Cap Piercer and Sampling Devices will take a few extra
seconds to perform aspiration before the OT begins to aspirate.)
The system will then perform the cleaning process for all analysis modes simultaneously,
5
and upon completion instrument is ready for next analysis.
Perform a background check to verify all values are within range. See Section 5.3 for more
6
details.

LCD Display When necessary, gently clean the display with a soft cloth, slightly moistened
with water and a mild soap. Dry carefully.

64
8.3 Six (6) Month Cleaning
Description To increase the life of internal tubing in the instrument, the following cleaning
procedure is strongly recommended.

Cleaning  Press [ADVANCED] from Main menu, then press [MAINTENANCE], and
Procedure then press [CLEANING MENU] to enter the Cleaning Menu.
 Follow the instruction for the Boule Cleaning kit to clean the instrument.
(Instructions for use are supplied with the Boule Cleaning kit solutions).
 The Six Month Cleaning procedure takes approximately one hour and 15
minutes to complete.

Figure 8.1 Figure 8.2 Figure 8.3

Boule Cleaning The Boule Cleaning Kit contains the following items:
Kit  Hypochlorite (2%)
 Enzymatic cleaner
 Detergent cleaner

Cleaning Depending on daily sample analyses, it is recommended that the following

Interval cleaning intervals be followed:
Less than 50 samples/day = every six months
More than 50 samples/day = every three months
100 – 200 samples/day = every month

8.4 Instrument Maintenance

Description This section describes the maintenance that is required to maintain and increase
the life of the instrument. Refer to local distributor for warranty requirements.

Maintenance The maintenance should be performed at the following intervals by local

distributor or authorized service technician:
 1 year or 20,000 samples

65
8.5 Re-location of instrument (within the laboratory)
Description This section describes the procedure performed to move the instrument over
very short distances. (From table to table).

Before the re- If the instrument is in “standby” mode do not unplug instrument. Make sure
location that the instrument is in Sample or List menu before turning off.
Step Action
Do not detach the reagent level sensors or waste line, place the sensors on top of the
1
instrument when moving. (Avoid reagent level sensor contact.)
Remove the waste line from waste container or drain, but do not detach tube from
2
analyzer.
3 Disconnect all electrical connections.

Re-location Make sure that the instrument is lifted from beneath to avoid unnecessary stress
on the front cover.

After re-location
Step Action
1 Place the waste line in waste container or drain.
2 Reconnect the electrical connections.
3 Insert the level sensors back into the reagent containers.
4 Power on unit.
5 Perform Prime.
6 Verify Background.
It is recommended that the performance of the Swelab Alfa system is checked with
7
certified blood controls authorized by Boule.

8.6 Short Term Shutdown (<12h)

Description This section describes the procedure when transporting or shutting down the
instrument for a shorter period of time (< 12 hours).

Empty System
Step Action
1 Remove the reagent level sensors from the reagent containers.
2 Press [ADVANCED] button on MENU tab.
3 Press [MAINTENANCE] and then [EMPTY SYSTEM].
When empty procedure is complete, the following statement will appear on screen:
4
‘System is empty and ready for fill or power off.’
5 Switch off power and then unplug analyzer.

Before the re- After instrument is powered off, detach reagent level sensors, waste line, all
location electrical connections, and sample wheels (if applicable). Package all
components carefully for transport.

66
8.6 Short Term Shutdown (<12h) (continued)

Guidelines for  The instrument should be transported in temperature conditions between 5

transport to 32 ºC (41 to 90 ºF)
 Humidity should be less than 80%.

8.7 Re-packaging and Long Term Transport (>12h)

Description This section describes the procedure when transporting or shutting down the
instrument for a longer period of time (>12 hours).

 It is very important to follow the below instructions for preparing the

analyzer for long term transport or re-packaging, to avoid erroneous results
upon re-installation.
Important  The main difference between Section 8.6 and 8.7 is the importance of
cleaning the instrument with the Boule cleaning kit and distilled water, prior
to re-packaging to avoid contaminates.

Long term Shut-Down

Step Action
Select [EMPTY SYSTEM] from MAINTENANCE Menu. See Section 8.6
1
“Short Term Shutdown” for emptying instructions.
Remove the reagent sensors from the reagent containers and follow the
2 instructions for the Boule cleaning kit. (Instruction is supplied with the Boule
cleaning kit solutions).
After completing the cleaning of the instrument, insert the reagent sensors into
3
distilled water. Select [CLEAN CYCLE FILL] from CLEANING Menu.
When the instrument has been filled with distilled water select [CLEAN CYCLE
4
EMPTY] from CLEANING Menu.
When system is emptied, disconnect the main supply cable and other connections
5
such as reagent sensors and waste line.
6 If transporting instrument, pack securely using the original shipping container.
Mark the container with DELICATE INSTRUMENT, FRAGILE and THIS SIDE
7
UP.
8 Follow Guidelines for transport below.

Guidelines for The instrument in its export package should fulfill the following
transport transport/storage conditions:
 Does not exceed - 40°C for ≥ 24 hours.
 Does not exceed a Dry heat of + 70°C for ≥ 24 hours.
 Dramatic change of temperature between - 40°C and + 30°C.
 Does not exceed a Damp heat steady state of 90% RH and + 40°C
during 48 hours.
 Does not exceed a Damp heat cyclic of 90-100% RH and + 25°/+40°C
12+12 hours.

67
8.8 Permanent Shut-Down and Storage
Permanent Shut-
See Section 8.7 Long Term Transportation.
Down and Storing

8.9 Disposal Information

Description Customers are advised to be knowledgeable of applicable local, state and
federal requirements, and the content of effluent streams, before disposing of
waste in public sewer systems or recycling decontaminated equipment.

Disposal  Used reagents

Materials  Reagents mixed with potentially biohazardous material
 Instrument and instrument components
 Controls and calibration material

Manufacturer  Place the instrument close to a waste container or drain suitable for disposal
Guidelines for of used reagents.
waste products  Check that the drainage is suitable for disposal of chemical and biological
waste.
 Check that the waste line is securely fastened in the drain.

Always use protective gloves when working with the waste container, waste
line and when in contact with potentially biohazardous materials.
Mandatory Action

Instrument decontamination and disposal

The European Directive 2012/19/EU on Waste Electric and Electronic

Equipment (WEEE) aims to minimize the impact on the environment by
prevention of waste. The Swelab Alfa hematology analyzer has been labeled
with the WEEE symbol (as given in the margin) and there is a procedure to
allow waste collection and recycling of the equipment at the end of it's life
cycle.

 The instructions for decontamination can be found on the Swelab home

page www.swelab.com under User Support.
Important
 If there are any question on how to follow this procedure, contact your
local distributor for more information.

The analyzer should be considered as infected and the end user must follow a
decontamination procedure before it is safe to hand over to a recycler.
Warning

68
Section 9: Parameter and System Information
Messages
Section Overview
Introduction The Swelab Alfa has several parameter and system information messages
related to the measured parameters and the instrument. These messages alert
the operator of possible pathologic samples and parameter value and
instrument errors.

Contents This section contains the following topics:

Topic See Page

Out-of-Range and Information Message Indicators 69
System Information Messages 70
Parameter Limitations of Blood Cell Counters 72

9.1 Out-of-Range and Information Message Indicators

Description The instrument has several out-of-range, parameter, system information

messages related to the measured parameters and the instrument. The
messages are shown on the display and printouts.

Out-of-Range  A parameter that is outside the “Normal Range”, refer to Section 4.5 for
Indicators User Interface setup, is either marked with “H” or “L” on the printout and
display to indicate if the value is higher or lower than the pre-set
“Normal Range” values.
 #### indicates an out of displayed range parameter, the count is too high
or too low to measure. If it is expected that the parameter is too high, the
sample can be diluted and rerun, and then the dilution factor can be
multiplied with the result to calculate the correct value.

Description of For System Information Messages, the touch screen’s i-button becomes active
System when a message is present. The user has the preference to access this information
Information detail by either touching the i-button on the touch screen or reviewing the printout.
Indicators System Information Messages are outlined in detail below.

Abnormalities All samples with anomalies and /or abnormal distributions signaled by the
instrument should be analyzed manually by a blood smear. Pathological cells
may vary in their stability towards lysing of their cytoplasmic membranes
compared to normal cells, which may cause aberrations in the automated
analysis. This also applies to the presence of normal non-pathological cells
that have been subjected to chemotherapy or other treatments.

69
9.2 System Information Messages

Description The system software monitors a number of analytical and system functions and will display
information that indicates the possible attention of the operator. This information will alert the
operator to check the system or sample or institute selected troubleshooting procedures. This
information is presented on the touch screen as a code next to one or more parameters.
Additional detail and recommendations may be accessed by either pressing the i-button on the
touch screen or reviewing the printed report.

System Information Messages

Aspiration Indicators (Sample Probe)

Indicator Message Description Action
Possible reasons for AF flag include a short
sample, clogging or air bubbles in sample
Aspiration failed, check tube. Check profile type is correct and
AF
sample Note: This flag is also displayed when then re-analyze sample.
running a background count (blank) without
selecting the background analysis profile.
Distribution Indicators (RBC, PLT, WBC)
Indicator Message Description Action
The size distribution of the cell pulses
departs from the expected one. Possible
Small particle reasons might be pathological blood sample
DE Re-analyze sample.
interference; re-analyze (e.g. nRBCs), PLT clumps, air bubbles,
electrical disturbances, incomplete lysing or
incorrect gain setting.
It was not possible to find the correct
position for the floating RBC/PLT
RBC/PLT: Irregular distribution curve. This flag often occurs on
FD Re-analyze sample.
Distribution, re-analyze low PLT counts. The FD flag should only
be reported if the corresponding parameter
(PLT) value is high enough.
HGB Indicators (HGB)
Indicator Message Description Action
The instrument detected a problem during
HGB Measuring Problem
HF the filling of liquid in WBC counting
– run prime cycle
chamber during HGB blank.
Run a “Prime cycle”, before re-
HGB Measuring Problem The HGB blank or sample readings reported
HH analyzing the sample.
– run prime cycle a too high light level.
HGB Measuring Problem The HGB blank or sample readings reported
HL
– run prime cycle a light level that was too low.
HGB Measuring Problem The HGB sample reading reported more
Wait one minute, and then re-
HN – wait one minute then light than the blank reading. This gives a
analyze sample.
re-analyze negative HGB value.
Switch off the analyzer and
HGB Measuring Problem The HGB dark (offset) reading reported a
HO switch it back on after 3 seconds,
– restart system light level that was too high or too low.
and then re-analyze sample.
HGB Measuring Problem Run a “Prime cycle”, before re-
HS Individual HGB readings vary too much.
– run prime cycle analyzing the sample.
Note: If various HF, HH, HL, or HN Indicators repeatedly appear check High Altitude Compensation, mode may need to
be changed to Moderate or Maximum compensation in higher elevations. A more detailed description can also be found in
the User Definable Settings document, which can be located at www.swelab.com > Support > Downloads > Public >
Documents.

Continued on next page

70
9.2 System Information Messages (continued)

Measuring Chamber Indicators (RBC, PLT, WBC)

Indicator Message Description Action
The cell pulses arrived faster than the analyzer
could process them. Possible reasons might be air
bubbles, electrical disturbances or incomplete
Measurement warning – lysing.
OR Re-analyze sample
re-analyze Note: Filtered away cell pulses might raise the OR
flag, so it might not be possible to see them in the
histograms or the result parameters. This is a hard
limit determined by the software.
The rate of cell pulses per time unit varies too
much. Possible reasons might be clogging, air
bubbles, electrical disturbances or difficult to lyse
Measurement Statistics
SE cells. Re-analyze sample
Warning; re-analyze
Note: Filtered away cells might raise the SE flag,
so it might not be possible to see them in the
histograms or the result parameters.
Mixing Beaker Indicators (RBC, PLT, WBC)
Indicator Message Description Action
The analyzer detected an abnormality during the
Run a “Prime cycle”,
Liquid System Problem – emptying of the first dilution from the mixing
TE before re-analyzing the
run prime cycle beaker. Reasons for flagging might be timeout, or
sample.
too short of a transfer time.
Reagent and Control Indicators (RBC, PLT, WBC, LYM/MID/GRAN)
Indicator Message Description Action
EC Expired control A control blood was used past its expiry date. Use a fresh blood control
The reagent was used past its expiry date. Change
ER Expired Reagent Use a new lot of reagents
to a non-expired lot of reagent.
The analyzer’s capacity counter has gone below
zero and no reagent is detected. Reason for no
Not enough reagent left,
NR reagent may include empty reagent container or Check reagent levels
check reagent levels
reagent level sensor not inserted correctly into
reagent container.
Reagent Pipette Indicators (RBC, PLT, WBC)
Indicator Message Description Action
The instrument detected an abnormality during
Diluent system problem one of the fill cycles of the diluent pipette.
DF
– run prime cycle Reasons for flagging might be timeout, short time
or bubbles at the upper detector.
The instrument detected an abnormality during
Diluent system problem one of the empty cycles of the diluent pipette.
DP
– run prime cycle Reasons for flagging might be timeout, short time
Verify instrument is filled,
or liquid not detected at the lower detector.
run a “Prime cycle” and
The instrument detected an abnormality during the
then re-analyze sample.
Lyse system problem – fill cycle of the lyse pipette. Reasons for flagging
LF
run prime cycle might be timeout, short time or bubbles at the
upper detector.
The instrument detected an abnormality during the
Lyse system problem – empty cycle of the lyse pipette. Reasons for
LP
run prime cycle flagging might be timeout, short time or liquid not
detected at the lower detector.

Continued on next page

71
9.2 System Information Messages (continued)

Reagent Pipette Indicators (RBC, PLT, WBC)

Indicator Message Description Action
The time for the liquid meniscus to pass from
Air bubbles – run prime
ST the lower to the upper detector is
cycle
unreasonably short.
Air bubbles – run prime Air bubbles were detected by the start detector
TB
cycle in the measuring tubes. Run a “Prime cycle”, before re-
Possible orifice analyzing the sample.
The liquid meniscus in the measuring tube
TL blockage: Run prime
never passed the lower detector.
cycle and then re-analyze
Possible orifice The liquid meniscus in the measuring tube
TU blockage: Run prime passed the lower detector but never passed the
cycle and then re-analyze upper one.
WBC Differential Abnormalities (LYM, MID, GRAN)
Indicator Message Description Action
WBC DIFF: High
Incorrect entry of MID ranges, the values Re-enter MIDL and MIDH
BD interference between
overlap. values.
populations.
There was only one mode in the WBC
WBC DIFF: Only one distribution between the LYM-L and GRAN- Blood sample too old or
OM WBC population found; H settings. Often in pathological samples with pathological sample. Slide
slide review advised. granulocytosis or lymphocytosis a blood review advised.
smear is recommended.

9.3 Parameter Limitations of Automated Blood Cell Counters

Description This section describes the different factors that may interfere with HCT, HGB,
MCV, MPV, PLT, RBC, RDW, WBC and WBC differential determination.

HGB Limitations
Turbidity, in the blood sample, due to any number of physiological and/or therapeutic factors may produce
falsely elevated HGB results. The instrument however, is compensated throughout the linear range of the
instrument.
Limitation Description
Unlysed Red Blood Cells Increased turbidity may be seen in cases where the red blood cells are resistant to
lysing. This condition will cause a falsely elevated HGB result but can be detected
by monitoring the MCHC.
Leukocytosis Extremely elevated WBC may produce falsely elevated HGB results due to
turbidity. In case of extreme WBC counts, the following is recommended: The
diluted sample should be centrifuged and the supernatant fluid checked on a
spectrophotometer for turbidity.
Lipemia, Elevated lipids in the blood sample will give the plasma a “milky” appearance
hyperproteinemia and which may disturb the spectrophotometric measurement of HGB. Similar problems
hyperbilirubinemia may occur with hyperproteinemia (high protein concentration) and
hyperbilirubinemia (high bilirubin concentration). Accurate HGB determination
can be achieved by using reference methods and a plasma blank.
Fetal blood The mixing of fetal and maternal bloods may produce a falsely elevated HGB
value.

Continued on next page

72
9.3 Parameter Limitations (continued)

MCV / HCT Limitations

As HCT is the product of MCV x RBC, any erroneous result in MCV and/or RBC will produce an equal error
in the HCT parameter.
Limitation Description
Red Blood Cell Agglutination of RBC may produce an erroneous MCV value and therefore a
Agglutination false HCT.
WBC An excessive number of WBCs might cause interference within the RBC
population and therefore a false MCV value.
Thrombocytosis (elevated Excessive numbers of PLT, in most cases, do not interfere with the MCV param-
PLT) eter due to the use of the floating discriminator technology in the instrument.
PLT / MPV Limitations
Measurement of low PLT levels may influenced by circulating RBCs, which may cause falsey high results.
Measurement of high PLT levels is influenced by coincidence factors (e.g. counting of two cells as one) which
may produce falsely low results. The instrument is compensated for these effects by separate algorithms to
produce linearity ranges according to the specifications.
Limitation Description
Microcytosis (small RBC, Very small RBCs might falsely elevate a PLT count and affect the MPV. This
low MCV) effect is minimized in the instrument due to the use of a floating threshold
(discriminator). By observing the PLT and RBC histograms, this effect is seen as
an overlapping PLT/RBC area.
Agglutinated RBCs Agglutinated RBCs might trap platelets and may give an erroneous low PLT
count and affect the MPV. The presence of agglutinated RBCs is detected by
monitoring the MCHC parameter and by careful examination of the stained
blood film.
Giant platelets in excessive This may cause a low PLT count since they might fall within the RBC threshold
numbers range.
Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells,
which may cause low PLT counts. Reference (manual) methods may be
necessary to obtain an accurate platelet count.
Hemolysis Hemolyzed specimens contain red cell stroma, which may elevate platelet
counts.
A.C.D. blood Blood anti coagulated with Acid Citrate Dextrose may contain platelet
aggregates, which could depress the platelet count.
RBC inclusions Erythrocyte inclusions may also produce a spuriously increased platelet count.
(e.g. Howell-Jolly bodies, siderotic and basophilic granules)
Platelet agglutination Clumped platelets due to poor collection techniques or platelet satellitosis caused
by EDTA activation of immunoglobulins may cause a decreased platelet count
and/or an elevated WBC count. The specimen should be recollected in sodium
citrate anticoagulant and re analyzed for only the platelet count. The final PLT
result must be corrected for the sodium citrate dilution effect.
MPV Limitations
Giant platelets Large platelets counted as RBCs will fall outside the PLT range and therefore
lower the MPV.
Small erythrocytes Very small RBCs might fall into the PLT region and might be counted as PLTs
and therefore influence the MPV parameter.
Agglutinated erythrocytes This may trap platelets and therefore affect the MPV parameter. Note that
agglutinated erythrocytes may be detected by carefully examine the MCHC
parameter and/or the stained blood film.
Chemotherapy May also effect the size of the PLTs.
EDTA Note that all samples collected in EDTA will not maintain a stable MPV. The
PLTs will swell as a function of time and temperature.

73
9.3 Parameter Limitations (continued)

RBC Limitations
The red blood cell dilution contains all the cellular elements of the blood: RBC, WBC, and PLT. Platelets are
not counted since the size falls below the discriminator threshold. Leukocytes are included in the RBC count,
but since the ratio of RBCs to WBCs is approximately 1000:1, the introduced WBC count is almost negligible.
Exceptions are noted below.
Measurement of high RBC levels is influenced by coincidence factors (e.g. counting of two cells as one) which
may produce falsely low results. The instrument is compensated for this effect by an algorithm to produce a
linearity range according to the specifications
Limitation Description
Leukocytosis In samples where the WBC is very high and at the same time the RBC is low, the WBC may
with cause a false increase in the RBC count. The WBC is always included in the RBC count, but
concurrent the contribution is not significant under normal circumstances. The RBC count may be
anemia corrected by simply subtracting the WBC from RBC.
Agglutinated This might cause a falsely decreased RBC count. Blood samples containing the agglutinated
Red Blood red blood cells may be identified by observing abnormal MCH and MCHC values, as well as
Cells by examination of the stained blood film.
Cold IgM immunoglobulins which are elevated in cold agglutinin disease may lower RBC and PLT
Agglutinins counts and increase the MCV.
RDW Limitations
The red cell distribution width is a function of the RBC count and derived from the RBC histogram. In most
cases, any error introduced in the MCV may also cause the RDW to be erroneous.
Limitation Description
Blood Blood transfusions may raise the RDW significantly due to the presence of bi-modal
transfusions populations.
WBC Limitations
Measurement of high WBC levels is influenced by coincidence factors (e.g. counting of two cells as one)
which may produce falsely low results. The instrument is compensated for this effect by an algorithm to
produce a linearity range according to the specifications.
Limitation Description
Leukocytosis WBC in concentrations that exceeds the linearity limits of the system will require dilution of
the blood sample. Re-assaying the diluted sample will help to obtain the correct assay value.
Nucleated Immature, nucleated red blood cells are large and not lysed like mature RBCs, thus they will be
Red Blood classified as a WBC and may cause falsely elevated WBC and lymphocyte results. If the
Cells, NRBC number of the NRBC is sufficient to activate the DE alarm, such interference will be detected.
An overview of a stained blood film can reveal the presence of NRBCs.
Unlysed Red In particularly rare instances, the RBC in the blood sample may not completely lyse like
Blood Cells expected. These non-lysed cells may be detected on the WBC histogram with a DE alarm, or as
an elevated baseline on the side of the lymphocyte population. Non-lysed RBCs will cause a
falsely elevated WBC and lymphocyte count. (See also NRBC above)
Hemolysis Hemolyzed specimen contains red cell debris, which may falsely elevate the WBC and/or PLT
count. Hemolysis can be detected by looking at the color of the plasma in an EDTA-sample
that has been allowed to sediment.
Leukemias This disease state may result in a spurious low WBC count, if the leukocytes are more fragile
than normal and becomes destroyed in the sample. The cell fragments will also interfere with
the WBC differential parameters (LYM, GRAN and MID). A falsely low WBC count may also
be seen in patients with lymphocytic leukemias due to the presence of abnormally small
lymphocytes, which may not be counted by the instrument.

74
9.3 Parameter Limitations (continued)

Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of the
leukocytes, which may cause falsely low WBC counts.
Cryoglobulins Increased levels of cryoglobin may cause elevated levels of WBC, RBC or
PLT counts as well as HGB. Cryoglobulins may be associated with myeloma,
carcinoma, leukemias, macroglobulinemia, lymphoproliferative disorders,
metastatic tumors, autoimmune disorders, infections, idiopathic disease,
aneurism, pregnancy, thromboembolic phenomena, diabetes, etc. The
specimen can be warmed up to 37°C and re-analyzed immediately or a manual
WBC, RBC or PLT count can be performed.
Multiple myeloma The precipitation of proteins in multiple myeloma patients may give falsely
elevated WBC counts.
Large lymphocytes, The presence of large or atypical lymphocytes, blasts, or an excessive number
atypical lymphocytes, of basophils may interfere with the MID cell area which otherwise consists
blasts, and basophils in mainly of monocytes.
excessive numbers
Metamyelocytes, The presence of excessive numbers of metamyelocytes, myelocytes,
myelocytes, promyelocytes, blasts and plasma cells may interfere with an accurate
promyelocytes, blasts granulocyte count.
and plasma cells in
excessive numbers

75
 Section 10: Technology
Section Overview

Introduction This section describes the different methods and principles of measurement
and calculations.

Contents This section contains the following topics:

Topic See Page

Measuring Principles 76
Counting Time RBC & WBC 77
WBC Differentials 78
Photometric Method – HGB Hemoglobin 79
Parameter definitions 79

10.1 Measuring Principles

Description This section describes the measuring principles of the Swelab Alfa.

General
The measuring principles of the Swelab Alfa are based on impedance and
Measuring
Principles spectrophotometry principles.

Whole Blood The number of cells for determining RBC and WBC values are counted from a
Dilution suspension of 1:40,000 for the RBC and 1:400 for the WBC dilution ratio of
whole blood.

Theoretical If a sample contains 5 million red blood cells per µl, a dilution of 1:40 000
Principles will give a final concentration of 5 million divided by 40,000 = 125 cells per
(RBC Example) µl. Each µl containing 125 cells, drawn through the aperture, will generate 125
pulses.

Continued on next page

76
10.1 Measuring Principles (continued)

Measured The measured volume drawn through the aperture is 270 µl (Manufacturer
Volumes calibrated). Based on the assumption made above, the system will count
(Example) 270*125 = 33,750 pulses, which is equivalent to 5.0x106 cells/µl in the
concentrated blood.

Stop sensor

Flow
Measured
Volume

Start sensor

Figure 10.1

Theoretical The calculation principle for white blood cells is the same but with a
Principles difference in dilution ratio and cell quantity. An example of this could be as
(WBC Example) follows: 5,000 cells/ µl diluted 1:400 =12.5.

10.2 Counting Time RBC & WBC

Description The counting time is defined as being the time needed for the sample to fill the
metering unit from the start to the stop detector.

Counting Time The normal counting time limits for the RBC and WBC metering units are
Limits between 13 – 18 seconds and 10 – 13 seconds respectively. If the counting
time is below or exceeds the above mentioned limits, the flag ST, TL or TU
will be displayed.

Note The ´counting time´ is not related to the actual result. Atmospheric pressure
variations, protein built up within the orifice (aperture) and other secondary
effects that might cause pressure changes will NOT affect the counted
parameters RBC, PLT and WBC.

77
10.3 WBC Differentials

Description The Swelab Alfa uses a fixed discriminator technology.

Fixed The differentiation of the WBC cells into lymphocytes, mid-cells and granulo-
Discriminators cytes is presented in the number of cells per liter or cubic millimeter and in the
percentage of the total number of WBC cells. The MID discriminator of WBC
is set to 140 and 180 fl. The WBC histogram is automatically adjusted
depending on the number of cells, i.e. expanded for low values and
compressed for high values.

Volume lysed WBC (fl)

Figure 10.2 (Normal distribution curve)
Differential  LYM region (small size cells): Ranges from 30 to 140 fl. Cells in this area
parameters typically correlate to lymphocytes. Other cell types that could locate in this
region are nucleated red blood cells, clumped platelets, macrocyte platelets,
variant (atypical) lymphocytes or blasts.

 MID region (mid size cells): Ranges from 140 to 180 fl. Cells in this area
typically correlate to monocytes, eosinophils and basophils and also
degranulated neutrophils, precursor cells, blasts and plasmacytes.

 GRA region (large size cells): Ranges from 180 to 600 fl. Cells in this area
typically correlate to neutrophils. In approximately 20% of the samples eosi-
nophils can also locate in this region. Precursor granulocytic cells, especially
bands, have a tendency to locate close to the mid cell region.

78
10.4 Photometric Method – HGB Hemoglobin
HGB The hemoglobin is determined from the same dilution as the WBC. For each sample a
(Hemoglobin blank is measured as a reference, this means that any drift in reagent-, cuvette-
Concentration) absorption, or diode is eliminated. The photometer system consists of a photodiode, a
cuvette with a length of 15 mm and a filter at a wavelength of 535 nm (bandwidth 20
nm). The HGB readings are slightly corrected for turbidity in case of extreme WBC
counts. The diode is switched off if the instrument is in standby mode, giving it an
extended lifetime.

Figure 10.4

10.5 Parameter Definitions

Description This section describes the parameter definitions that have not been defined yet in
other sections.

MCV ( Mean  The MCV parameter is derived from the RBC distribution curve. As the
Cell Volume distribution curve has a maximum volume range of 250fl, the maximum channel
RBCs) also contains clumps of cells that are larger than this volume. Therefore this
channel is excluded from the MCV calculation. The MCV is calculated from the
volume position of the discriminator to 249 fl. Be aware that the discriminator
might be 'floating' or fixed by the user in the 'Discriminator set-up program'
 In general, RBC counts that are lower than 0.60 (displayed value) do not give a
MCV/HCT value due to low statistical significance.
 If the MCV is calibrated by using the 'calibration' procedure, in the user manual,
the whole curve is recalculated and moved in a correct way that reflects the new
calibration setting. The printed curve will therefore always be correct in respect to
the actual MCV value.

RDW (Red Cell The RDW parameter is calculated from the RBC distribution curve. The CV of the
Distribution curve is calculated. However, the CV is only calculated on a portion of the curve.
Width) This avoids that other populations might interfere. The RDW value is therefore only
measured on a portion of the RBC size distribution curve. I.e. not all particles are
included in the RDW calculation. The RDW parameter is only valid if the MCV value
is not zero.

HCT The HCT is defined as being the packed volume of red cells in whole blood and is
(Hematocrit) calculated through MCV * RBC. If no MCV is derived from a sample due to too low
a number of RBC cells, no HCT is calculated.

79
10.5 Parameter Definitions (continued)

PLT (Platelets)  Platelets are defined (for the purpose of discrimination) as cells in a range from
2.5fl to the discriminator level that is either set on a fixed volume or 'floating' and
determined by the software on each sample. The setting of the upper discriminator
is done in the setup menu.
 The platelets are determined from the same dilution as the RBC, in fact, the system
is counting just 'cells' during the RBC/PLT counting process. The determination of
which cell is a PLT or RBC is done at the end of the counting procedure and fully
determined by the setting of the user defined discriminator behavior (‘floating’ or
fixed)
 Example: Let us suppose that a sample contains 200,000 platelets/µl in whole
blood. After a dilution of 1:40,000 the sample contains 200,000 divided by 40,000
= 5 cells/µl. So, each µl drawn through the aperture gives 5 pulses. As the counting
volume (the volume of the metering glass tube) is 270 µl, the total number of cells
that are analyzed will be 5*270=1350 cells.
 In other words, the total number passing through the orifice when determining the
PLT is the value shown on the display screen without decimals multiplied by the
division factor 6.75.
 The reproducibility is directly dependent on the total number of cells entering the
orifice.
 Measuring PLT from the same dilution as RBC, the CV will be less than 3.5% for
most of the samples within normal range. A 'mean' CV of about 3.2 % is expected
for well-treated fresh EDTA whole blood samples within the range of 250-350
10e3/uL.
 As the system uses an orifice size of 80 µm diameter, coincidence losses will take
place with extreme sample RBC/PLT counts. The system has a well-balanced
mathematical correction algorithm for these effects within the software.
 Please note that if a floating discriminator is used and no well-defined minimum is
found between the RBC and PLTs the reproducibility of mainly the PLT is
affected. To check the reproducibility of the low PLTs, it might be wise to put the
analyzer in a fixed discriminator mode to exclude any error introduced by a not
well-defined RBC-PLT population.

MPV (Mean  The mean cell volume of the platelets is determined from the PLT size distribution
Platelet Volume) curve.
 The MPV is defined as being the mean value of the PLT size distribution curve
from the lower discriminator (2.5 fl) to the position of the upper discriminator
which can be programmed as 'floating' or fixed.
 MPV is not displayed in case of extreme low PLT counts due to high statistical
inaccuracy of such a population.

MCH (Mean Cell The MCH is a calculated value and is defined as HGB/RBC giving the mean HGB
Hemoglobin) concentration in the red cells.

MCHC (Mean  The MCHC is a calculated value and is defined as HGB/HCT.

Cell Hemoglobin  The MCHC is calculated from 3 measured parameters and therefore an excellent
Concentration) instrument stability check. MCHC=HGB/HCT=HGB/(MCVxRBC).
 In general it could be stated that if a daily mean value is found outside the range
32-36 g/dl, the instrument has been incorrectly calibrated. The daily mean value of
the MCHC parameter should always be 34.5 +/- 1.5 g/dl.

80
 Section 11: Specifications
Section Overview

Introduction This section describes the specifications for the Swelab Alfa and its parameters.

Contents This section contains the following topics:

Topic See Page

General 81
Short List of Specifications 82
Parameter Ranges 83
Reagent and Reagent Consumption 84

11.1 General

Description This section describes the Swelab Alfa and its parts in general.

User The operator works with a menu from which the desired program is chosen,
Environment e.g. discriminator settings.

Reagents Two external reagent reservoirs are used:

 Isotonic diluent (Diluent)
 Hemolyzing reagent (Lyse)

Technology The Swelab Alfa is a fully automatic hematology analyzer designed to

measure up to 20 parameters using whole blood from an open inlet, closed
tubes, 20µl micropipettes or pre-diluted blood.

3-Part WBC The instrument performs a 3-part WBC differential by means of a cyanide free
hemolyzing reagent.

Protected A sample memory is available and protected against main power failures. The
Sample Memory sample memory also contains a search function with selective printing and QC
Options.

81
11.2 Short List of Specifications

Specifications (Short)

Measuring principle Impedance

RBC, WBC, PLT
Measuring principle HGB Photometer, Cyanide free method 535nm ±5nm
Programmable WBC Discriminator Yes
Sampling system Closed shear valve
Parameters reported RBC, MCV, HCT, PLT, MPV, HGB, MCH, MCHC,
WBC, RDW%, LYMF abs, MID abs, GRAN abs,
LYMPH%, MID%, GRAN%, RDW abs, PDW abs,
LPCR, PCT
Size distributions printed for RBC, PLT and WBC diff.
Aspirated blood volume (Open Tube) < 110 µl
Aspirated blood volume (Cap Piercer) < 250 µl
Aspirated blood volume (Auto Sampler) < 300 µl
Sample display time (Open Tube) ≤ 50 seconds
Blood volume, Micro Capillary Inlet (MCI) 20 µl
Pre-diluted mode 1:200 to 1:300 using min. 20 µl
e.g. 20 µl to 4.5 ml diluent (1:225)
TFT-LCD display Graphical color touch screen, 240 columns x 320 rows
Keyboard Virtual incorporated keyboard (External keyboard
option)
Number of Samples per hour (Open Tube) > 60 samples
Number of Samples per hour (Cap Piercer) > 45 samples
Number of Samples per hour (Auto Sampler) > 43 samples
QC capabilities Mean, SD, CV, Levey-Jennings plots and X-B with
>10,000 samples history
Control sample memory capacity > 1000 control samples
Sample memory capacity > 1000 samples
HGB correction on high WBC counts Yes
Warning flags on parameter abnormalities Yes
Floating discriminator RBC/PLT Yes (position printed)
Automatic HGB blank on each sample Yes
Carry over HGB, PLT, RBC, WBC ≤ 1%
Barcode reader input Yes
Serial output Yes (Conformed to standard EN 60950)
Main Voltage 100 – 240 V AC
External Power Adapter 24 V DC
Power consumption Max 100VA
Power consumption (stand-by) Max 20VA
Frequency 50 / 60 HZ
Built-in test / adjustment programs Yes
Temperature 18 - 32°C (64 - 90°F)
Humidity (noncondensing) Up to 80%
Dimensions (Basic/Standard/Closed Tube) HxWxD = 410 x 290 x 460 mm
Dimensions (Auto Sampler) HxWxD = 430 x 330 x 460 mm
Instrument weight (Basic/Standard/Closed Tube) ≤ 18 kg
Instrument weight (Auto Sampler) ≤ 22 kg
Diluent Consumption Approximately 22 ml per analysis cycle.
Lyse Consumption Approximately 4.5 ml per analysis cycle.

82
11.3 Parameter Ranges
Linearity-Regression Linearity measured according to Boule I-1040 Section 8, based on Standard
and Linear Range EP6-A.

Parameter Difference (whichever is greater) Linearity Range

WBC ± 0.4 x 109/L or 3% 0.5 – 99.9 x 109/L
RBC ± 0.05 x 1012/L or 2% 0.30 – 7.00 x 1012/L
PLT ± 10 x 109/L or 3% 20 – 1800 x 109/L
HGB ± 0.2 g/dL or 2% 2.0 – 24.0 g/dL

Displayed Range Total range where results are reported, also outside of linearity range.

Parameter Displayed range

WBC 0 - 119.9 x109/L
RBC 0.00 – 14.00 x1012/L
MCV 15.0 – 250.0 fL
PLT 0 - 1999 x109/L
HGB 0.0 – 35.0 g/dL

Correlation Correlation was performed, using an Advia 120 as references. Data derived from
965 normal and abnormal fresh blood samples.

Parameter Correlation Coefficients (R2), Advia

WBC ≥ 0.98
RBC ≥ 0.97
MCV ≥ 0.98
PLT ≥ 0.98
HGB ≥ 1.00

Reproducibility Measured as an average of 10 measurements each on 9 different vein K2-EDTA

collected normal samples, on 3 instruments, in OT, MCI, Cap Piercer, and Auto
Sampler modes.

Parameter OT CV (%) MCI CV (%)

WBC 7.0 x109/L 1.8 2.5
RBC 4.59 x1012/L 0.9 1.5
MCV 86.8 fL 0.5 0.5
PLT 239 x109/L 3.0 3.0
HGB 14.3 g/dL 0.8 1.3

Total System Typical value from QC testing (n=10), using Boule Con. Calculations are based
Precision on 380 instruments, using the highest moving average value of 50 instruments
as a typical value for each parameter.
Parameter CV (%)
WBC  1.8
RBC  1.1
MCV  0.3
PLT  3.3
HGB  1.0

83
11.4 Reagents and Reagent Consumption
Description This section describes the reagent consumption for the Swelab Alfa depending
on a sample per day calculation.

Supported Reagents Use only Boule authorized reagents. Erroneous results and damage may occur if
other reagents are used.

Diluent Consumption Approximately 22 ml per analysis cycle

Lyse Consumption Approximately 4.5 ml per analysis cycle.

Consumption The consumption can be approximately calculated depending on the number of

Calculation samples per day as shown on the graphs below. The figures, presented in the
graphs, assume one exit standby and one wash per day.
The consumption relation between the Isotonic diluent and the hemolyzing
reagent is 5:1, based on 50 samples per day.

Diluent Consumption
Diluent Consumption
30

25

20
ml/sample

15

10

0
25 50 75 100 125 150 200

Samples/day

Figure 11.1

Lyse Consumption
Lyse Consumption
6

4
ml/sample

0
25 50 75 100 125 150 200

Samples/day

Figure 11.2

Additional For additional information regarding the consumption of cleaning solutions please
Information refer to the Boule Cleaning Kit instruction. (Supplied with the Boule Cleaning Kit).

84
 Section 12: Troubleshooting
Section Overview
Introduction This section contains information needed to troubleshoot the Swelab Alfa
instrument.

Contents This Section contains the following topics:

Topic See Page

Communication Issues 85
General Information Displays 87
Warning Displays 92
Aspiration Issues 97
Troubleshooting Other Issues 98

12.1 Communication Issues

Description This section contains information regarding errors associated with printers,
barcode readers and serial data communication.

Printer Issues See Section 4.3 Printer Modes for further detail.

If Then Possible cause

The printout has unusual 1. Verify that printer type 1. New printer was connected but
layout or strange matches the printer being used. not matched with analyzer
characters. 2. Verify that the correct paper setup.
format has been selected for 2. Printer may need maintenance
the printer paper. or to be reset.
Results are not printing 1. Verify that Auto Print Mode is 1. Auto Print Mode was turned
out after sample or NOT set to ‘0’. off and not reset.
control analysis.
1. Printer Alarm message is 1. The printer is not connected to
displayed. the instrument or the printer
2. Printer is not ready to print, setup is incorrect.
wait unit printer has finished 2. The printer has not completed
with previous printout. last printout.
3. Verify that printer is connected
the instrument.
4. Verify that the setup of the
instrument is correct for the
printer in use.

Continued on next page

85
12.1 Communication Issues (continued)

1. The Printer is connected to the 1. The printer has timed out.

instrument and on, but not 2. Printer paper may need to be
activated. refilled.
2. Verify that printer is not in 3. Incorrect setup for information
standby or offline. transmission.
3. Verify that printer is set to
print and not serial port only
setup.

Serial Data Issues See Section 4.3 Data Communication for further detail.

If Then Possible cause

The data sent does not 1. Make sure that the correct HW 1. Serial setup in analyzer is
seem correct handshake and Auto Send incorrect.
Mode has been selected.
Results are not being 1. Verify that Auto Send Mode is 1. Auto Print Mode was turned
sent to computer after NOT set to ‘0’. off and not reset.
sample analysis
1. Serial Output in not ready to 1. The analyzer has not
transmit. completed transmission of last
2. Wait until previous sample has sample.
finished transmitting.
3. Then resend selected sample.

1. Make sure that the HW 1. The serial output has timed

handshake has been selected. out.
2. Verify that analyzer is 2. The computer is not
connected to computer. connected to the instrument or
3. Verify that computer is turned the serial output setup is
on. incorrect.
4. Verify that analyzer is set to
serial output and not print
mode only.

Continued on next page

86
12.1 Communication Issues (continued)

1. Make sure that the Send with 1. Serial output Ack. problem.
Ack. has been selected.
2. Verify that computer is turned
on and connected to the
analyzer.
3. Verify that computer’s
receiving program is active.

12.2 General Information Displays

Description This section contains information regarding general information displays.

General General information displays are informative screen displays that appear after
Information a function has been completed. Instruction is then displayed for the operator
Displays on next step or function to be performed.

Standby, Power Down, and Power Up Informational Displays

The system is empty from all liquid The system is filled with liquid and is The system has not been used during
and prepared to be filled with other prepared for power off. Press [PWR the preset display saver time. Press
liquid or be stored away. Press UP] if you want to return the system [RESUME] to activate the
[FILL] if you want to refill system to active status or [EXIT] if you want instrument. Once activated, the
or [EXIT] if you want to return to to return to instrument menu. It is instrument is ready to perform an
instrument menu. No analyze can be recommended to use [ENTER analysis.
performed before the instrument is STANDBY] and that power is left on,
refilled with reagents. instead of using this feature.

Continued on next page

87
12.2 General Information Displays (continued)

Instrument will enter Standby mode The instrument is in the process of The system is in Standby. Press
in 2 minutes. Press [CANCEL] to going into Standby. Please wait. [EXIT STANDBY] to activate the
return to instrument menu. instrument. Once activated, the
instrument is ready to perform an
analysis.
Standby, Power Down, and Power Up Informational Displays

The system is preparing the The instrument is in process of The instrument is in process of
instrument for analysis mode. If the powering down. Please wait. powering up. Please wait.
background check is activated,
background result will be displayed.
Once activated, the instrument is
ready to perform an analysis.

Continued on next page

88
12.2 General Information Displays (continued)

Diluent Dispense Informational Displays

The instrument is preparing to The instrument is now dispensing 4.5 The instrument is exiting dispense
dispense diluent. Dispose of first ml of diluent. Please wait. function. Please wait.
dispense for best results.
Cycle In Progress Informational Display

The instrument is priming the The instrument is filling the system. The instrument is emptying the
system. Please wait. Please wait. system. Please wait.

Continued on next page

89
12.2 General Information Displays (continued)

The instrument is cleaning the Open Every twelve hour the instrument The system has finished the count of
Tube needle. Please wait. performs a wash of the system. cells and displays the results. The
During wash cycle the instrument analysis cycle in not yet completed,
can not be used for performing an as the system still needs to perform
analysis. wash cycle for an accurate next
sample result. Please wait until the
[NEW SAMPLE] button is
activated. If needle was submerged
in next sample by mistake, perform a
background count before continuing
with the next analysis.

The printer is in the process of The analyzer is in the process of Instrument displays this notice to
printing. Please wait. transmitting serial output data. inform operator that ComboPack
Please wait. reagents will soon need to be
changed. (See Section 2.5 for more
detail.)

Continued on next page

90
12.2 General Information Displays (continued)

Reagent and Control Informational Displays

Instrument displays this notice to Instrument displays this notice to Instrument displays this notice when
inform operator that Diluent reagent inform operator that Lyse reagent will reagent container or containers need
will soon need to be changed. (See soon need to be changed. (See Section to be changed. Not changing
Section 2.5 for more detail.) 2.5 for more detail.) reagents at this time could cause
erroneous results or possible damage
the instrument.

The reagent barcodes were scanned The Assay Values were scanned in
in correctly using the barcode reader correctly using the barcode reader and
and the instrument has accepted the the instrument has accepted the
values. values.

91
12.3 Warning Displays

Warning Warning displays appear after a function has been performed incorrectly or to
Displays inform the operator that further action is needed to complete the desired task.
The warning display describes the situation and instructs the operator on next
step or function to resolve issue.

System Power Down Warning Displays

The system has been switched off The system was switched off The system was manually switched
for a long time period. The incorrectly. Perform a prime to off with system emptied of reagents.
instrument has been powered down prepare the system for analysis. Check Fill the instrument with reagents to
with all valves open and filled with method for correct instrument power prepare for analysis or exit if only a
liquid. Empty and refill the system down procedure. search of instrument menus is
with reagents, and perform a needed.
background count.

The instrument has been switched The system was powered down with The regular 12 hour wash has failed.
off with power down function liquid in system and has been unused Make sure that reagent containers
before power was switched off. for long period of time. Perform the are filled and the detectors are
Perform a power up to prepare the cleaning procedure according to inserted correctly.
reagent system for analysis. cleaning kit instruction. Perform a
background check.

Continued on next page

92
12.3 Warning Displays (continued)

Reagent Warning Displays

The regular 12 hour wash has not The reagent container or containers This message is displayed if reagent
been performed. Check if reagent are empty. Check if the containers are container or containers are empty
containers are empty and if the empty and if level sensors and reagent when coming out of Standby. Check
reagent detectors are in contact with contact plugs are inserted correctly. if the containers are empty and if
reagent. level sensors and reagent contact
plugs are inserted correctly.

ComboPack container needs to be Diluent container need to be changed. Lyse container needs to be changed.
changed. Not changing reagents at Not changing reagents at this time Not changing reagents at this time
this time could cause erroneous could cause erroneous results or could cause erroneous results or
results or possible damage the possible damage the instrument. possible damage the instrument.
instrument. Connect new reagent Connect new reagent container and Connect new reagent container and
container and scan in barcode on scan in barcode on container. (See scan in barcode on container. (See
container. (See Section 2.5 for Section 2.5 for more detail.) Section 2.5 for more detail.
more detail.)

Continued on next page

93
12.3 Warning Displays (continued)

Barcode Warning Displays

No more space is available to scan Assay value input failed. The Assay Reagent barcode scanning failed.
in new Assay Values. Follow the Sheet or order of scanning in the Barcode printing or order of
recommendation or manually delete barcodes may have been incorrect. scanning in the barcodes may have
all the controls with same ID, to Verify that setups on the instrument been incorrect. Verify that setups on
free space for scanning the new match the required setup for the the instrument match the required
Control Lot. (See Section 6.1 for barcode reader. (See Section 4.3 setup for the barcode reader. (See
more detail.) and 6.1 for more detail.) Section 4.3 and 4.4 for more detail.)
Open Tube Warning Displays

The instrument was unable to wash The instrument was unable to wash The instrument is unable to wash the
the Open Tube aspiration needle. the Open Tube aspiration needle. Open Tube aspiration needle. Verify
Verify that tube is removed and Verify that tube is removed and wash that tube is removed and wash
wash device is in correct position, device is in correct position. It is device is in correct position. It is
then perform OT Wash. recommended that background count recommended that background count
is performed before next sample is performed before next sample
analysis. analysis.

Continued on next page

94
12.3 Warning Displays (continued)

Capillary Device Warning Displays

The MCI was opened during an The MCI was opened during a cycle The MCI holder was opened during
inappropriate time. It is or analysis. Re-insert holder, and an inappropriate menu. The MCI
recommended to perform a prime follow suggested recommendation. holder should only be opened in
cycle before next analysis. List, Sample or Main menu.
Cap Piercer and Auto Sampler Warning Displays

The Cap Piercer door was opened The aspiration wheel has been Three aspirations have been
before the CAP door lock had been interfered with during mixing. Press attempted. All have failed. Verify
activated. Close the Cap Piercer [OK] to return to the sample menu. To that sample tubes contain at least 1
door to continue with the analysis. proceed with the analyses press ml of blood. (See Section 5.9 for
[CONTINUE] in Auto Sampler List more detail.)
Menu.

Continued on next page

95
12.3 Warning Displays (continued)

A counting error has been detected in OT wash device was touched while Incorrect authorization code was
Auto Sampler mode. Verify that sampling device was running. See entered. See calibration section in
tubes are in correct position and Section 5.9 if emergency sample User’s Manual for entry of correct
order. (See Section 5.9 for more analysis is needed. authorization code for calibration, or
detail.) contact local distributor or
authorized service technician.for
service related authorization codes.
Authorization Code and Installation Warning Displays

No authorization code was entered. Reagent level sensors must be Instrument has detected liquid in the
See calibration section in User’s removed from the reagent containers system. The empty cycle must be
Manual for entry of correct when emptying the system. Verify run prior to a fill cycle. Run the
authorization code for calibration, or that both level sensors have been Empty function to remove any extra
contact local distributor or authorized removed. liquid remaining in the system then
service technician for service related fill the instrument with reagents.
authorization codes.

96
12.3 Warning Displays (continued)

Assay Value Input failed. The Assay The barcode scanned in is not
sheet or order of scanning in the recognized as a control sample in the
barcodes may have been incorrect. system. Verify that control sample is
Verify that setups on the instrument being scanned in. ( See Section 6.1
match the required setup for the for more detail.)
barcode reader. (See Section 4.3
and 6.1 for more detail.)

12.4 Aspiration Issues

Description This section contains information regarding errors associated with aspiration
and the aspiration needle.

If Then Possible cause

No aspiration of 1.Verify that there are no leaks and tubing is 1. Blockage of tubing or leak
sample is taking connected properly and not kinked. causes sample to not be pulled
place. 2.Perform valve check in Service Menu correctly through shear valve.
3.Perform clot prevention. See Section 8.2. 2. Valve malfunction.
4. If clot prevention cycle does not work 3. Clot in sample caused by
perform clot removal procedure. See incorrect sample handling or
Appendix A. pathologic sample.
No cleaning of 1. Suggest cleaning upper area of aspiration 1.Sample tube is touching the upper
aspiration probe needle. part of the aspiration needle
2. Verify that there are no leaks and tubing is when analyzing.
connected properly and not kinked 2.Diluent is not flowing correctly
through tubing to aspiration
needle.

97
12.5 Troubleshooting Other Issues

Description See Troubleshooting Flowchart in Appendix A for other possible issues that
may arise. Areas on Flowcharts highlighted in dark grey should only be
performed by service technician or authorized personnel.

Indication Error Indications error codes are specific instrument situations that in most cases
Codes need the attention of the operator or might need service action.
 The three number indications usually occur after the two number
indications. For example, an indication 302 will be displayed due to
interference with an OT analysis. It states that the OT cycle was aborted.
 The first indication display is the most important as it describes the issue
and how to solve the problem. The three digit indication after a two digit
one is added information for the user.
 In most cases, the instrument is stopped and the operator has to confirm
with [OK] to continue. Once [OK] is pressed and instrument returns to
display menus, user should repeat previous actions again (e.g. re-analyze
sample, printing results, etc.)
 If indication error appears again or a three digit indication was displayed
as the first indication message, contact local distributor or authorized
service technician.

Indication Series Description

1 - 19 Indication series for auxiliary errors like battery faults or similar.
20 - 29 Indication series for ‘Liquid’ errors.
30 - 39 Indication series for Communication errors between the PCBs (CAN
bus).
40 - 49 Indication series for Printer and serial output errors.
50 - 59 Indication series for General Memory errors.
60 - 69 Indication series for EEPROM/HPC (High Performance Controller)
errors.
70 - 79 Indication series for Shear Valve problems.
80 - 89 Indication series for Cap Piercer errors (Closed Tube Adaptor)
90 - 99 Indication series for Sampling device errors.
Indication series for internal hardware and software problems, and
100-255
messages during subboard firmware upgrades.
300 -399 Indication series for cycle aborted indication numbers.

98
 Index
MPV ..........................................................................24, 43, 60, 62, 72, 73, 82
A
Advanced menu ...... 17, 25, 26, 27, 28, 29, 30, 33, 35, 59, 60, 64, 65, 66, 102 N
Analysis Profile ............................................................................................. 33 NEW SAMPLE ..................................................................... 39, 40, 42, 50, 90
Aspiration Issues ........................................................................................... 97 Normal ranges ................................................................................... 33, 35, 69
Aspiration needle ............................20, 39, 41, 48, 55, 59, 63, 64, 94, 97, 101
Assay Values ............................................................. 54, 57, 60, 61, 91, 94, 97 O
Authorization code ...................................................................... 34, 58, 61, 96 Open Tube .................................. 17, 24, 36, 40, 41, 42, 59, 60, 62, 82, 90, 94
Auto Sampler10, 17, 20, 24, 48, 49, 50, 51, 60, 63, 64, 82, 83, 95, 96, 98, 102 Operator ID........................................................................................ 34, 40, 61
Out-of-range indicators ................................................................................. 69
B
Background count ........ 19, 32, 34, 37, 38, 39, 44, 64, 70, 88, 90, 92, 94, 102 P
Barcode................................................................ 13, 39, 40, 50, 51, 93, 94, 97 Parameter Limitations ........................................................... 69, 72, 73, 74, 75
Barcode reader.... 10, 12, 18, 20, 27, 29, 48, 49, 55, 57, 60, 82, 85, 91, 94, 97 Parameter Ranges .......................................................................................... 83
Barcode setup ................................................................................................ 29 PCT .......................................................................................................... 24, 82
PDW .................................................................................................. 24, 62, 82
C PLT ............... 19, 24, 33, 39, 43, 45, 60, 62, 70, 71, 72, 73, 74, 75, 77, 82, 83
Calibration ........................................................... 17, 19, 59, 60, 61, 62, 67, 96 Power Down ...................................................................................... 87, 88, 92
Calibrators ......................................................... 5, 6, 10, 37, 41, 54, 55, 59, 68 Power supply ................................................................................. 7, 14, 18, 19
Cap Piercer ......................... 17, 20, 24, 47, 48, 60, 62, 64, 82, 83, 95, 98, 102 Power Up ............................................................................... 12, 37, 87, 88, 92
Cleaning ...................................................................................... 59, 63, 64, 65 Pre-dilute .......................................................17, 42, 43, 44, 50, 60, 62, 64, 82
Cleaning kit ............................................................. 10, 64, 65, 67, 84, 92, 102 Pre-dilute needle ............................................................20, 42, 43, 44, 63, 101
Clot Prevention................................................................................ 64, 97, 101 Prime ...............................................................................32, 70, 71, 72, 92, 95
Clot Removal................................................................................. 97, 101, 102 Printer ............................................... 10, 12, 14, 20, 27, 28, 35, 85, 86, 90, 98
Control barcodes ............................................................................... 13, 38, 57
Controls 5, 6, 10, 13, 20, 37, 38, 41, 50, 54, 55, 56, 57, 58, 59, 62, 68, 71, 82, Q
94, 97, 102 QC.. ........................................................ 20, 54, 55, 56, 57, 58, 60, 62, 81, 82
CV.. ................................................................................................... 61, 82, 83
R
D RBC .............. 19, 24, 33, 39, 43, 60, 62, 70, 71, 72, 73, 74, 75, 76, 77, 82, 83
Date/time function ................................................................................... 12, 26 RDW ............................................................................................ 24, 62, 74, 82
DE.................................................................................................................. 74 Reagent barcodes.......................................................13, 17, 18, 31, 32, 91, 94
DF.. ................................................................................................................ 71 Reagent consumption .............................................................................. 82, 84
Dilution Rates................................................................................................ 42 Reagent container ..... 13, 15, 16, 17, 18, 19, 20, 31, 32, 66, 67, 81, 92, 93, 96
Dispense function ............................................................ 20, 42, 43, 44, 64, 89 Reagent level sensors ................. 10, 12, 13, 14, 15, 16, 18, 66, 67, 71, 93, 96
Disposal ................................................................................................... 16, 68 Reagent setup .............................................................................. 17, 18, 31, 32
Distributor ................................ 4, 7, 12, 19, 27, 28, 35, 61, 62, 65, 68, 96, 98 Reagents5, 6, 10, 12, 13, 15, 17, 18, 31, 32, 55, 68, 71, 81, 84, 87, 90, 91, 92,
DP.. ................................................................................................................ 71 93, 96
Results ...... 6, 20, 28, 36, 38, 42, 43, 51, 52, 55, 59, 72, 74, 85, 86, 89, 90, 98
E
EDTA .......................................................................................... 36, 44, 74, 83 S
Emergency Procedure ..................................................................................... 7 Safety features ...................................................5, 6, 7, 16, 46, 48, 63, 68, 101
Emergency sample .................................................................................. 50, 96 Sample analysis . 12, 17, 26, 33, 36, 41, 42, 44, 45, 47, 48, 50, 52, 60, 62, 64,
Empty ................................................................................................ 66, 67, 96 86, 94
Erroneous results .......... 6, 7, 18, 19, 26, 36, 37, 41, 44, 46, 64, 67, 84, 91, 93 Sample collection .............................................................................. 36, 45, 47
Sample ID ............................................................34, 39, 40, 42, 48, 49, 50, 51
F Sample memory................................................................................. 34, 81, 82
Fill 13, 16, 17, 18, 66, 67, 71, 87, 89, 92, 96 Sample menu .................. 34, 35, 40, 41, 42, 44, 45, 47, 51, 55, 56, 60, 66, 95
Fixed discriminator ....................................................................................... 78 Sample statistics ................................................................................ 33, 34, 58
Floating discriminator ................................................................................... 73 Sample View ........................................................................................... 52, 53
Send Mode............................................................................................... 28, 86
G Sequence number .................................................................. 34, 35, 49, 51, 55
General Information Displays ............................................... 87, 88, 89, 90, 91 Serial number ............................................................................................ 3, 19
GRAN.................................................................................... 24, 71, 72, 74, 82 Serial output ..............................................................28, 82, 85, 86, 87, 90, 98
Service .........................................................................4, 5, 11, 19, 97, 98, 102
H
Service technician ...............................................5, 19, 61, 62, 65, 96, 98, 101
HCT ............................................................................................. 24, 43, 73, 82
Setup ............................... 14, 17, 25, 26, 27, 28, 29, 30, 31, 69, 85, 86, 94, 97
Hemolysis ................................................................................................ 46, 74
Setup menu ............................... 17, 26, 27, 28, 29, 30, 33, 34, 35, 51, 58, 102
HGB ........................................................24, 39, 43, 60, 62, 70, 72, 75, 82, 83
Specifications .......................................................................................... 81, 82
I Standby ................................................................23, 32, 37, 66, 84, 86, 87, 88
i-button .................................................................................................... 69, 70 Startup ............................................................................................... 13, 37, 38
Indication error codes .................................................................................... 98 Storage ............................................................................................... 55, 67, 68
Installation ...............................................10, 11, 12, 13, 15, 16, 17, 19, 67, 96 Summary report ............................................................................................. 35
Instrument settings .................................................................................. 25, 35 System Information Messages .......................................................... 51, 69, 70

K T
Keyboard ........................................................................................... 10, 30, 82 Target values ................................................................................................. 61
TL.. ................................................................................................................ 72
L Transport ........................................................................................... 55, 66, 67
Language ....................................................................................................... 27 Troubleshooting .......................................................................... 55, 70, 85, 98
Levey-Jennings Plots .............................................................................. 57, 58 TU.. ................................................................................................................ 72
List menu .............................. 25, 34, 41, 42, 44, 45, 47, 51, 55, 56, 60, 66, 95
LPCR ....................................................................................................... 24, 82 U
LYM ............................................................................................ 24, 71, 72, 78 USB ....................................................................................... 14, 27, 28, 30, 35
User Definable Settings............................................................................. 4, 35
M
Main menu.......................................17, 18, 41, 44, 45, 47, 51, 60, 65, 95, 102 W
Maintenance ................................................................................ 59, 63, 65, 85 Warning Displays ............................................................92, 93, 94, 95, 96, 97
Maintenance menu ........................................................ 17, 64, 65, 66, 67, 102 Warning signs .................................................................................................. 7
MCH ............................................................................................ 24, 58, 74, 82 Warranty .................................................................................................... 5, 65
MCHC ............................................................................. 24, 58, 72, 73, 74, 82 Wash cycle ..........................................................32, 41, 84, 90, 92, 93, 94, 96
MCI ...................................... 10, 17, 20, 44, 45, 46, 47, 50, 60, 62, 82, 83, 95 Waste ................................................................................................... 6, 37, 68
MCV ........................................................24, 43, 58, 60, 62, 72, 73, 74, 82, 83 Waste container ........................................................................... 12, 16, 66, 68
Measuring principles ..................................................................................... 76 Waste line ........................................................................10, 12, 16, 66, 67, 68
Menu Structure ........................................................................................ 21, 22 WBC 19, 24, 33, 39, 43, 45, 58, 60, 62, 70, 71, 72, 73, 74, 75, 76, 77, 78, 81,
Micropipette .......................................................................... 36, 44, 45, 46, 47 82, 83
MID ....................................................................................... 24, 58, 71, 78, 82
X
Mixer ................................................................................... 20, 26, 36, 51, 102
Xb function .............................................................................................. 33, 58
Monthly QC............................................................................................. 56, 57

99
 Appendix A
Clot Removal This process will help operator to remove a clot from the system. This should only
be used when the OT aspiration needle is blocked and Clot Prevention procedure
can not be performed. THIS SHOULD ONLY BE PERFORMED BY A
SERVICE TECHNICIAN OR AUTHORIZED PERSONNEL.

Step Action
Remove outer cover:
 Press release lever on underside of cover.

Figure 13.1
 While pressing release lever, place one hand on top of analyzer to stabilize and then
gently pull bottom of cover forward (only enough to slide pass release lever).

Figure 13.2 Figure 13.3

 Place both hands on upper sides of cover and carefully pull towards you.

Figure 13.4
 Place cover aside.
 Be very careful when removing cover to not damage analyzer.
 Follow directions and do not force.
 Be aware of aspiration and pre-dilute needles.
Important  Wear protective gloves and safety goggles for this procedure.

100
CLOT REMOVAL PROCEDURE (continued)
Step Action
Disable blood mixer by selecting [ADVANCED] from Main menu, then [SETUP], then [SETUP 2],
2 then [SETUP 3], and then [MIXER SETUP]. To inactivate select button and select ( [ ] ). Press [EXIT]
four times to return to Advanced menu.
Prepare a syringe by attaching a piece of maintenance tubing to syringe tip and fill syringe with 2%
3
Hypochlorite solution. (Hypochlorite from the cleaning kit can be used.)
4 Locate the Valve 27, the lower valve directly to the left of shear valve.
Locate the L (elbow) connector on the right-hand side of this valve and disconnect the L connector from
5 ONLY the tubing that is threaded through valve. (For Cap Piercer and Sampling Device disconnect tube
from T connector between Valves 27 and 30.)
6 From Main Menu press [ADVANCED] and then press [SERVICE].

Figure 13.5 Figure 13.6

Attach prepared syringe tubing to L connector, press [CLOT REMOVAL], press [OK], and gently apply
pressure back and forth to syringe until clot is loosened. If obstruction is not removed at this point, flush
in 2% Hypochlorite solution and wait 15 minutes allowing the solution to dissolve the clot

Figure 13.7 Figure 13.8

After 15 minutes, if screen has gone blank, touch screen and select [RESUME]. Press [OK] to run clot
9 removal cycle and, using the syringe, flush again. Thoroughly flush tubing with 2% Hypochlorite
solution until all obstructions are removed.
10 Disconnect syringe and reattach L connector to valve tubing.
Replace analyzer cover:
 Carefully align top edge of analyzer and display with cover.
 Gently, partial push on upper part of cover to fit over display.
11
 Using both hands on sides of covers, slowly press on, fitting over aspiration plates.
 If aligned properly release lever will automatically click into place, there will be no spacing between
cover and display, and aspiration plates will move freely.
Once cover it replaced, press [EXIT] twice to exit out of Service menu. Select [MAINTENANCE] and
12
then perform [CLOT PREVENTION]. See Section 8.2 for more detail
Reactivate the blood mixer by following the steps in Step #2. At the mixer SETUP screen, press the
13
button and select ( [X] ). Press [EXIT] five times to return to main menu.
Run a background count and check that it is within limits (See Section 5.2), and if necessary a control to
14
verify that clot removal was successful.

101
102
 Discordant Results
Verify that sample is
mixed correctly and tube
has correct ratio of blood Questions to ask:
to anticoagulant. 1. Was sample collected and handled properly?
2. Was the same sample used for both in-house and outside lab analysis?
YES 3. Different blood draw and/or different tube?
4. Could the sample have been switched with another patient?
5. Could discordance be due to age changes during shipping or time periods
NO Is HCT low
between blood draw and analysis (RBC swelling, platelet clumping,
compared to
deterioration of WBC for differential)?
spun HCT? YES

NO Is HCT
Go to ’Are both RBC out-of-range? NO Go to control out of
Are controls Repeat using correct
and HGB low’ below. range Troubleshooting
within range? procedure
protocol
YES NO
YES NO
NO
Is RBC Is MCV
out-of-range? out-of-range?
NO YES Was calibration YES Was calibration
Are all parameters
YES recently protocol followed
discordant?
performed? correctly?

Check that sample is YES

mixed correctly and no Is MCHC NO YES
hemolysis or lipemia is out-of-range?
present.
Change out NO Are reagent
NO Were all
NO reagent and re-
levels ok? parameters low?
analyze sample.
Wait 2 minutes YES Is HGB
and then run a YES Perform
out-of-range? YES
background count Maintenance

Review differences that can be

Go to High Background NO Is monthly or 6- YES
expected when comparing
Troubleshooting protocol month maintenance
results from same system, from
due?
YES Is PLT different systems, etc.
NO
out-of-range?
Run a
background NO
count. Values
NO
Examine blood film Perform Clot Prevention
OK?
procedure and
YES Are re-analyze sample.
RBC & PLT both
1. Verify by looking at high or both
blood film. low?
2. Check sample for clots. YES
3. Review PLT histogram. NO Is sample Are results still
(verify bell-shaped curve) YES pathological? discordant?

Are
1. Check reagent level. WBC & HGB both NO NO
2. Run [Orifice Clean] cycle high or both
from Service Menu (possible YES
low?
blockage of aperture) DONE
3. Check if monthly or 6-month NO
maintenance is due.

YES Are
Contact Service
RBC and HGB
Representative
both low?
Contact Service
NO Representative
Re-analyze and/or
redraw sample. 1. Verify by looking at blood film.
Is WBC YES 2. Check sample for clots.
out-of-range? 3. Remix and check correct
sample handling followed.

103
104
105
 Noise Issues

Usual Cause:
1. Bad electrical outlet in clinic
2. Power Outage/Lightening

YES Go to user manual

Is SE flag
for SE message
present?
explanation

NO

Perform [Noise
Test], under Connect cables
Service Menu

YES

Are the values for the

Are any
Noise Test: YES
cables loose on back
RBC Ampl = 0
of analyzer?
WBC Ampl = 0

NO
NO

Try plugging
analyzer into
different outlet

Are noise NO
values above
limits?

YES

Try moving
analyzer to
another room.

Is Noise test NO
Done
positive?

YES
Contact Service
Representative

106
 TU or TL ERRORS

Re-analyze sample (system cleans and rinses the

orifice automatically when error is generated)

All highlighted areas of flowchart NO

TU/TL flag? DONE
are to be performed by trained in-
house technician ONLY.
YES
Perform a Prime, then a
DONE
background count

NO

Re-analyze
TU/TL flag? TU/TL flag?
sample
NO
YES
YES

Perform [Orifice Clean]

in Maintenance menu

Perform
background count

Check tubing to YES NO

Remove right-side
measuring chambers, TU/TL flag? DONE
cover.
re-attach if necessary.

Check tubing to air

membrane pump (SP1 &
SP2), re-attach if
necessary.

Is YES NO
Check tubing to Run a Prime cycles
liquid level above
metering units, followed by a TU/TL flag? DONE
orifice in measuring
re-attach if necessary. background count
chambers?

YES
NO

1. Perform Valve Check

2. Contact Service Representative
and give Valve Check results

107
 Appendix B
This page will not be translated from English.

This product uses some software which are distributed under the GPL and/or the LGPL licences.

Accordingly, Boule Medical AB makes the source code (including changes made by Boule Medical AB)
for the following GPL and/or LGPL licensed software available: U-boot, Linux Kernel, Busybox,
Liblockfile, Lockfile-progs, Udev, (Linux) Kbd, Mtdutils, Ghostscript, Ghostscript-Fonts, Gutenprint,
Glibc. In addition, it uses the Chinese Ghostscript font gpsn00lp.ttf which is under the Arphic Public
License. Contact [email protected] using the Subject line “BM800 GPL source code request” for
information about access to the source codes. Please refer to http://en.wikipedia.org/wiki/Gpl,
http://www.gnu.org/licenses/old-licenses/gpl-2.0.html and
http://www.gnu.org/licenses/old-licenses/lgpl-2.1.html for further info.

“This software is based in part on the work of the Independent JPEG Group.”

This product also uses fonts with the following copyrights:

Copyright 1984-1989, 1994 Adobe Systems Incorporated.

Copyright 1988, 1994 Digital Equipment Corporation.
Adobe is a trademark of Adobe Systems Incorporated which may be registered in certain jurisdictions.
Permission to use these trademarks is hereby granted only in association with the images described in this
file.
Permission to use, copy, modify, distribute and sell this software and its documentation for any purpose
and without fee is hereby granted, provided that the above copyright notices appear in all copies and that
both those copyright notices and this permission notice appear in supporting documentation, and that the
names of Adobe Systems and Digital Equipment Corporation not be used in advertising or publicity
pertaining to distribution of the software without specific, written prior permission. Adobe Systems and
Digital Equipment Corporation make no representations about the suitability of this software for any
purpose. It is provided "as is" without express or implied warranty.

Cyrillic, Euro and line drawing glyphs copyright 2000 Dmitry Yu. Bolkhovityanov, [email protected]

HR-Net fonts (c) 1995 A. Protopapas and A. Haritsis

Copyright (C) 1988 The Institute of Software, Academia Sinica.

Correspondence Address: P.O.Box 8718, Beijing, China 100080.
Permission to use, copy, modify, and distribute this software and its documentation for any purpose and
without fee is hereby granted, provided that the above copyright notices appear in all copies and that both
those copyright notices and this permission notice appear in supporting documentation, and that the name
of "the Institute of Software, Academia Sinica" not be used in advertising or publicity pertaining to
distribution of the software without specific, written prior permission. The Institute of Software,
Academia Sinica, makes no representations about the suitability of this software for any purpose. It is
provided "as is" without express or implied warranty.
THE INSTITUTE OF SOFTWARE, ACADEMIA SINICA, DISCLAIMS ALL WARRANTIES WITH
REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS, IN NO EVENT SHALL THE INSTITUTE OF SOFTWARE,
ACADEMIA SINICA, BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL
DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR
PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS
ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS
SOFTWARE.

108
 Art no 1504421 September 2014

Produced by Boule Medical AB

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