BT3600 & derivates OPERATOR MANUAL REV 04

Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY

OPERATOR MANUAL
BT3600 & derivates
P/N: MO7500-00ING

Rev. 04
Apr 2019
Software 1.0.6.0

This manual is valid for the BT3600 family analyzers and derivates.
The differences among the analyzers are highlighted where necessary.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079

E-mail: [email protected] Website: www.biotecnica.it

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BT3600 & derivates OPERATOR MANUAL REV 04
Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY

IMPORTANT NOTICES
1. USE OF THE UPS DEVICE

ATTENTION!
BIOTECNICA INSTRUMENTS ANALYZERS MUST OPERATE ONLY IF
CONNECTED TO AN UPS DEVICE.

BIOTECNICA WILL NOT BE RESPONSIBLE FOR ANY DAMAGE TO THE

ANALYZER OR INJURY TO PERSONS IF THE ANALYZERS ARE
OPERATED WITHOUT THE PROPER CONNECTION TO THE UPS DEVICE
OR WITHOUT THE UPS ITSELF.

2. ALL SYSTEMS

DO NOT CHANGE WINDOWS® THEME, DESKTOP OR OTHER

ELEMENTS. LEAVE THE SETTINGS AS RELEASED FROM THE FACTORY.
Some graphical elements may not be visible. Some OS settings may create
problems with the operative program visualization.
For instance, you can't see the arrows in the Parameters page:

Or, in certain conditions the Operative Program is reduced to icon and cannot
be opened again.

3. IMPORTANT NOTICE - SHORT DATE SETTING

In international settings -> Short Date Format, do not use entries that
transform the month number into a string because the date-to-date data
transformation functions only works with numbers and generates an access
violation in the Patient Archive, QC, Population and Standard archive. It also
does not allow the correct selection of the date in logs.
Only for the short date format
It must be a number, eg. 01.12.2017 and not 01-Dec-2017.
Set the two-character date, click Apply, and verify that the short date is only
numeric (check the displayed example). More than two characters usually do
not give a numeric string (use the MM option and not MMM or MMMM and
verify).

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BT3600 & derivates OPERATOR MANUAL REV 04
Biotecnica Instruments S.p.A. Via Licenza, 18 00156 Rome – ITALY

4. CLEANING OF THE ANALYZER AND SORROUNDING AREAS

The analyzer, the surrounding areas and the floor must not be cleaned or put
in contact with any detergent or other substance containing chloride. This will
cause damages to the analyzer external and internal structure.

5. IMPORTANT NOTICE ON THE PC USE

- all Biotecnica analyzers, all serial numbers, are closed systems

- all Biotecnica analyzers must not be internet-connected
- all Biotecnica analyzers do not need any Operative System update
- all Biotecnica analyzers are released from Factory virus-free and the
Manufacturer cannot be responsible for any virus or malware introduced by
the use of unauthorized or uncontrolled devices such as USB external
archives or by the connection to an unprotected or unsafe network
- for all Biotecnica analyzers, it is responsibility of the Owner to grant the
network to be safe when an analyzer is connected to it
- for all Biotecnica analyzers, the Manufacturer does not guarantee the correct
performances and considers the Warranty void if external programs are
installed
- for all Biotecnica analyzers, the Manufacturer does not guarantee the correct
performances and considers the Warranty void if any unauthorized or
uncontrolled device is connected to the analyzer.

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SUMMARY

CHAPTER 1 .......................................................................................................................... 9
GENERAL INFORMATION & SYSTEM DESCRIPTION ...................................................... 9
1. MANUFACTURER .......................................................................................................... 10
2. ANALYZER IDENTIFICATION AND INTENDED USE ................................................... 10
3. STORAGE, HANDLING AND OPERATING CONDITIONS............................................ 11
4. WARNINGS AND PRECAUTIONS ................................................................................. 11
5. ANALYZER INTRODUCTION......................................................................................... 15
6. BASIC OPERATING PRINCIPLES OF THE ANALYZER .............................................. 16
7. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS ........................ 17
8. BRIEF DESCRIPTION OF THE SYSTEM....................................................................... 21
8.1. Front view of the analyzer.......................................................................................... 21
8.2. Rear panel ................................................................................................................. 22
8.3. Modules ..................................................................................................................... 23
CHAPTER 2 ........................................................................................................................ 24
INSTALLATION .................................................................................................................. 24
1. UNPACKING INSTRUCTIONS ....................................................................................... 24
2. INSTALLATION .............................................................................................................. 26
2.1. Electrical connections ................................................................................................ 26
2.2. External PC and peripherals connection.................................................................... 26
2.3. Fluidic connections .................................................................................................... 27
3. STARTING THE INSTRUMENT...................................................................................... 28
3.1. Turning on the instrument for the first time ................................................................ 28
3.1.2. Preliminary checks ......................................................................................................... 29
3.1.3. Used solutions/detergents .............................................................................................. 30
CHAPTER 3 ........................................................................................................................ 31
FUNCTIONS........................................................................................................................ 31
1. BASIC THEORY ............................................................................................................. 31
1.1. Methods description................................................................................................... 33
2. DESCRIPTION OF THE PROGRAM MENU ................................................................... 35
2.1. Printing interface ........................................................................................................ 38
3. APPLIED MATHEMATICAL FUNCTIONS ..................................................................... 40
3.1. Initial Computation ..................................................................................................... 42
4. HOW TO PROGRAM THE ANALYSES ......................................................................... 43
4.1. Creating a new code .................................................................................................. 43
4.2. Relation tests ............................................................................................................. 43
4.3. Introduction to the clinical chemistry tests ................................................................. 45
4.4. Calculation and use of cycles .................................................................................... 46
5. ANALYSES PROGRAMMING ........................................................................................ 48
5.1. GENERAL ................................................................................................................. 48
5.2. REACTION ................................................................................................................ 50
5.2.1. REAGENTS.................................................................................................................... 50
5.2.2. TIMES ............................................................................................................................ 52
5.2.3. REACTION ..................................................................................................................... 52
5.2.4. BLANK ........................................................................................................................... 56
5.3. SAMPLE .................................................................................................................... 57
5.4. CHECK ...................................................................................................................... 63
5.5. SUPPLEMENTARY ................................................................................................... 68
5.6. AUTOMATIC REPETITIONS..................................................................................... 69
6. CALIBRATIONS ............................................................................................................. 70
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7. CONTROLS .................................................................................................................... 75
8. PROFILES ...................................................................................................................... 75
9. APPENDIX ..................................................................................................................... 77
CHAPTER 4 ....................................................................................................................... 80
PERFORMANCES & TECHNICAL SPECIFICATIONS ..................................................... 80
1. PERFORMANCE AND LIMITS ...................................................................................... 80
2. TECHNICAL SPECIFICATIONS .................................................................................... 81
CHAPTER 5 ....................................................................................................................... 83
OPERATIVE PROCEDURE ............................................................................................... 83
1. TURNING ON PROCEDURE ......................................................................................... 83
1.1. Automatic procedures, reminders & special errors ................................................... 84
1.1.1. Automatic procedures ..................................................................................................... 84
1.1.2. Reminders ...................................................................................................................... 84
1.1.3. Special errors ................................................................................................................. 84
1.2. ACCESS PASSWORDS ........................................................................................... 85
2. REAGENTS MANAGEMENT ......................................................................................... 88
2.1. Make tray .................................................................................................................. 88
2.2. Insert / Remove Reagents and volumes check ......................................................... 91
2.2.1. Inserting reagents "in run"............................................................................................... 93
2.3. Reagents swap procedure ........................................................................................ 93
3. CALIBRATIONS & CONTROLS .................................................................................... 95
3.1. Calibrations ............................................................................................................... 95
3.1.1. Programming Standards (Immediate) ............................................................................. 97
3.1.2. Linear calibrations with or without automatic dilution....................................................... 98
3.1.3. Non linear calibrations with or without automatic dilution ................................................ 99
3.1.4. Running calibrations ..................................................................................................... 100
3.1.5. Programming Standards (Timed) .................................................................................. 101
3.2. Controls .................................................................................................................. 102
3.2.1. Programming Controls (Immediate) .............................................................................. 103
3.2.2. Running controls........................................................................................................... 105
3.2.3. Programming Controls (Timed) ..................................................................................... 108
4. SAMPLES & SAMPLES TRAY .................................................................................... 109
4.1. Batch entry .............................................................................................................. 110
4.2. Patients entry .......................................................................................................... 112
4.2.1. Programming patients................................................................................................... 113
4.2.2. Programming STATs .................................................................................................... 121
4.3. Running samples .................................................................................................... 121
4.4. Current and Extra work-lists .................................................................................... 124
4.5. Samples Performed work-list .................................................................................. 125
4.6. Patients Management Options ................................................................................ 128
4.6.1. Repetitions for analyses ............................................................................................... 128
5. TURNING OFF PROCEDURE ..................................................................................... 129
5.1. Long-term Turning Off Procedure ........................................................................... 129
CHAPTER 6 ..................................................................................................................... 130
QUALITY CONTROLS ..................................................................................................... 130
1. QUALITY CONTROLS ................................................................................................. 130
1.1. New data ................................................................................................................. 131
1.2. Manage data ........................................................................................................... 132
1.2.1. Westgard graph ............................................................................................................ 133
1.2.2. Levey-Jennings graph .................................................................................................. 134
1.2.3. Daily chart .................................................................................................................... 135
1.3. Youden graph ......................................................................................................... 136
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1.4. Utility ........................................................................................................................ 137
2. QUALITY CONTROLS IN REAL TIME ......................................................................... 138
CHAPTER 7 ...................................................................................................................... 139
EXTERNAL ARCHIVES .................................................................................................... 139
1. EXTERNAL ARCHIVES ................................................................................................ 139
2. PATIENTS ARCHIVE .................................................................................................... 139
2.1. Manage data............................................................................................................ 139
2.1.1. Functions and Sort Order ............................................................................................. 141
2.2. Utility and Data menu .............................................................................................. 142
3. POPULATION ............................................................................................................... 143
3.1. New data ................................................................................................................. 144
3.2. Manage data............................................................................................................ 144
3.3. Principal Statistics Formulas Used In Population .................................................... 148
3.4. Utility and Data menu .............................................................................................. 150
4. CALIBRATIONS ARCHIVE .......................................................................................... 151
4.1 Manage Data ............................................................................................................ 152
4.2. Utility and Data menu .............................................................................................. 153
CHAPTER 8 ...................................................................................................................... 154
DISPLAYING AND PRINTING RESULTS ........................................................................ 154
1. DISPLAYING AND PRINTING RESULTS .................................................................... 154
1.1. Results page............................................................................................................ 154
1.2. Results RT page ...................................................................................................... 159
1.3. Graphs page ............................................................................................................ 160
1.4. Flags list .................................................................................................................. 162
CHAPTER 9 ...................................................................................................................... 163
SETUP .............................................................................................................................. 163
ANALYZER SETUP .......................................................................................................... 163
1. SYSTEM ........................................................................................................................ 163
1.1. Language................................................................................................................. 163
1.2. Printer ...................................................................................................................... 163
1.3. Access Passwords .................................................................................................. 164
1.4. Bar-code .................................................................................................................. 164
1.4.1. Bar-code on samples.................................................................................................... 164
1.4.2. Bar-code on reagents ................................................................................................... 165
1.5. I.S.E. Module ........................................................................................................... 166
1.6. Temperature ............................................................................................................ 166
1.7. Clot Sensors ............................................................................................................ 166
1.8. Administrator ........................................................................................................... 167
1.9. General Options ...................................................................................................... 167
2. Patients ........................................................................................................................ 167
2.1. Samples' Groups ..................................................................................................... 167
2.2. Communication ........................................................................................................ 168
2.3. Sort Results ............................................................................................................. 169
2.4. Diluents Identification............................................................................................... 170
CHAPTER 10 .................................................................................................................... 171
TECHNICAL FUNCTIONS ................................................................................................ 171
TECHNICAL FUNCTIONS ................................................................................................ 171
1. ANALYZER UTILITIES ................................................................................................. 171
2. MECHANICAL CALIBRATIONS .................................................................................. 172
3. DIAGNOSTICS.............................................................................................................. 175

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3.1. Maintenance ........................................................................................................... 176
CHAPTER 11 ................................................................................................................... 177
I.S.E. MODULE – 2P - SOLID STATE ............................................................................ 177
1. I.S.E. MODULE 2P ....................................................................................................... 177
1.1. Operating Principles ................................................................................................ 178
1.2. Applied Mathematical Functions ............................................................................. 179
1.3. Precautions For I.S.E. Module-2P Usage .............................................................. 180
2. PERFORMANCE AND LIMITS - I.S.E. MODULE-2P ................................................. 181
3. GENERAL INFORMATION ON THE I.S.E. MODULE-2P ............................................ 182
4. ANALYZER UTILITIES & OTHER I.S.E. FUNCTIONS ................................................ 183
4.1. Analyzer Utilities ..................................................................................................... 183
5. PROGRAMMING THE I.S.E. ........................................................................................ 184
5.1. PARAMETERS ....................................................................................................... 184
5.2. PROGRAMMING STANDARDS AND CONTROLS................................................ 186
6. REPLACING AND INSTALLING ELECTRODES ........................................................ 187
7. PRELIMINARY STEPS BEFORE STARTING THE SYSTEM ..................................... 188
7.1. Calibration Procedure ............................................................................................. 188
7.2. Measuring Unknown Samples ................................................................................ 189
8. MAINTENANCE AND TROUBLESHOOTING ............................................................. 189
8.1. Suggestions For Performance Maintenance. .......................................................... 189
8.2. I.S.E. Maintenance.................................................................................................. 190
9. TROUBLESHOOTING ................................................................................................. 191
10. I.S.E. MODULE-2P CONSUMABLES ........................................................................ 193
CHAPTER 12 ................................................................................................................... 194
ANALYZER DISPOSAL ................................................................................................... 194
1. RETURNING THE ANALYZER TO THE TECHNICAL ASSISTANCE SERVICE ....... 194
1.1. Operating Analyzer ................................................................................................. 194
1.2. Not Operating Analyzer ........................................................................................... 195
2. ANALYZER SAFE DISPOSAL .................................................................................... 196
3. ELECTRIC AND ELECTRONIC DEVICES DISPOSAL ............................................... 197
CHAPTER 13 ................................................................................................................... 198
MAINTENANCE & TROUBLESHOOTING ...................................................................... 198
1. MAINTENANCE AND CARE ....................................................................................... 198
1.1. Cleaning Of The Instrument .................................................................................... 198
1.2. Preventive Maintenance ......................................................................................... 198
1.3. Maintenance ........................................................................................................... 199
2. MALFUNCTIONS ......................................................................................................... 201
2.1. TROUBLESHOOTING ............................................................................................ 201
2.2. SCREEN MESSAGES ............................................................................................ 202
2.2.1. Screen Messages - Causes And Remedies .................................................................. 202
2.2.2. Screen Messages Requiring Technical Assistance ....................................................... 203
2.2.3. Optical System Verification Messages .......................................................................... 204
CHAPTER 14 ................................................................................................................... 205
SHORT INSTRUCTIONS ................................................................................................. 205
1. UNPACKING INSTRUCTIONS .................................................................................... 205
1.2. External PC and peripherals connection ................................................................. 206
1.3. Fluidic connections ................................................................................................. 206
1.4. Turning on the instrument for the first time ............................................................. 207
CHAPTER 15 ................................................................................................................... 208
COMMUNICATION AND SOFTWARE INSTALLATION ................................................. 208
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IMPORTANT NOTICE & WARNING ................................................................................. 208
1. ASTM PROTOCOL: INTRODUCTION ......................................................................... 209
1.1. Protocol Details ....................................................................................................... 209
1.2. Messages Sequence ............................................................................................... 210
1.3. Analyzer Programming ............................................................................................ 212
1.4. Receive Report ........................................................................................................ 213
1.5. Host Query .............................................................................................................. 215
1.6. Report Request ....................................................................................................... 216
2. INTERNAL COMMUNICATION .................................................................................... 217
2.1. General .................................................................................................................... 217
2.2. Wiring Diagram Of Interface Cable .......................................................................... 217
2.3. Internal communication: variable protocol ............................................................... 218
2.4. CALCULATION OF CHECK-SUM ........................................................................... 227
3. SOFTWARE INSTALLATION ....................................................................................... 228
CHAPTER 16 .................................................................................................................... 229
SUPPLEMENTARY INFO ................................................................................................. 229
1. WARRANTY CONDITIONS .......................................................................................... 229
2. ORDERING INFORMATION ......................................................................................... 231
2.1. General Terms And Conditions For Sale ................................................................. 231
2.2. Consumables........................................................................................................... 232
3. TECHNICAL ASSISTANCE .......................................................................................... 233
4. BIBLIOGRAPHY OF ALLIED SUBJECTS ................................................................... 234

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CHAPTER 1
GENERAL INFORMATION & SYSTEM DESCRIPTION

IMPORTANT NOTICE
The introduction of access passwords has been rendered
mandatory since 2004 for safeguarding sensitive data.
See chapter 5, par. 1.1

Pictures and images in the present manual may change without notice,

BT3600 & derivates OPERATOR MANUAL REV 04

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Chapter 1 General Information & System Description Page 10 of 234

1. MANUFACTURER
The analyzer and its derivates are produced by Biotecnica Instruments S.p.A., in its factory located
in Rome, Italy.
Biotecnica was founded in 1972, based on a lot of technical expertise and manufacturing know-how
in the design, production, sales and technical assistance of Biotecnica and OEM clinical chemistry
equipment and relevant reagent products destined for private and state clinical laboratories
(hospitals, clinics, day hospitals, and universities etc.). Since that time the company has developed
and produced the instruments of uncompromising performance characteristics, which has enabled
Biotecnica to become one of Europe’s leading manufacturers of clinical chemistry instruments.
Biotecnica is headquartered in Rome (Italy) and markets products both domestically and
internationally through a network of distributors.
Our actual range of instruments is composed basically of:
- Automatic analyzers for clinical chemistry.
- Flame photometers
- I.S.E. analyzers
Biotecnica has over 3000 square meters of manufacturing facility, which houses the latest in
engineering, manufacturing, testing and quality control equipment and is staffed by highly
experienced personnel.
The company supplies more than just products – it provides highly efficient technical and
manufacturing support based on the requirements of its customers supported by ongoing training
programs to keep you current on advances in technology. With a global network of distributors and
sales engineers, you can be assured of the most comprehensive customer support wherever you
are in the world.
For more information about Biotecnica, visit the Biotecnica web site at w w w . b i o t e c n i c a . i t
Please do not hesitate to contact us and we will be only too pleased to assist with any inquiries you
may have.

2. ANALYZER IDENTIFICATION AND INTENDED USE

The analyzer and its derivates are automatic analyzers for clinical chemistry and I.S.E.
determination in serum, urine, plasma, CSF for clinical chemistry - serum and urine for I.S.E..
The analyzers are equipped with an external computer for the operative program and data
management.
Note: This equipment is classified as IVD device (In vitro Diagnostic medical device) and it is subject
to each National Regulations for the IVD equipments.

Operating Principles
Generally, adding a sample to its reagent determines a chemical reaction (involving enzymes and/or
substrates) whose effect is to increase (or decrease) the solution color and thus the optical density
in the cuvette. As the reaction proceeds, it is "read" by the analyzer in terms of "absorbance" ("A" or
"Abs" for absorbance).
As every analyte has its own reagent with its proper characteristics, it becomes necessary to use
different methodologies (preparation and reading) based upon different wavelengths for each test.
Many tests are based on similar principles, hence they will have in common the method and the
wavelength, but not necessarily the incubation and reading times.
To obtain the concentration of an analyte in a sample, the analyzer multiplies the absorbance (or the
absorbance delta ∆A = absorbance variation) developed by that sample reaction with a
multiplication factor.
Besides some analyses for which a theoretical factor is used, usually the factor is calculated by
means of a calibration. During the calibration the analyzer reads the reaction obtained with a known
concentration sample called "standard". The factor is calculated by dividing the known concentration
value by the absorbance read for the standard.
For the non-linear analyses (e.g. immunoturbidimetric tests) it is necessary to create an interpolation
curve by means of several standards at different concentrations.
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3. STORAGE, HANDLING AND OPERATING CONDITIONS

STORAGE
- room temperature range 18°C - 32°C
- humidity 10% to 85% RH, non condensing.
HANDLING
For moving the analyzer at least two persons are necessary. The analyzer is equipped with four
handles for easier transportation.
For Indoor use only
OPERATING CONDITIONS
- room temperature range 18°C - 32°C
- humidity 10% to 85% RH, non condensing.
- altitude: max 2000mt
- supply voltage: 100-240 Vac (± 10%), 50/60Hz, 750W
- overvoltage category: II
- sound level: 55 dBA

4. WARNINGS AND PRECAUTIONS

Although the BT analyzers use high performance components, which provide a high degree of
safety, it is essential that the user takes the usual precautions to safeguard himself and to ensure a
safe working environment.
Biotecnica Instruments S.p.A. only guarantees the workmanship and materials of its products. It is
the duty of the user to take care of safe operation and no amount of warnings can take place of
such care.
To avoid accidental contamination, use suitable guards and/or personal protection, such as overall
and gloves.
The following warnings will aid the user to provide adequate safeguards to assure safe trouble-free
performance:
1 Before operating this system, be sure to read the operator manual thoroughly and carefully.
Afterwards, keep it handy for future reference.
2 Take special care to follow the warnings and cautions indicated on the system rear panel as
well as in the operator manual.
3 The use of the system must be restricted only to qualified laboratory personnel who have
been trained for the use of this analyzer model.
4 The safety of the device is compromised if it is used out of the specifications indicated by the
manufacturer. Do not use the system or any part of it for any other purpose than those which
are designated by the Manufacturer.
5 Service, maintenance and repair of any type must be performed by Biotecnica's technical
assistance personnel or by qualified service personnel trained by the Manufacturer's
technical assistance.
6 Pay the utmost attention when handling reagents and solutions dedicated to the analyzer.
Carefully read each kit / reagent / solution insert before using it.
7 Pay close attention when handling samples, standards, controls, calibrators, and any other
material to be used with the analyzer. Read the inserts of each product carefully before using
it.
8 Always wear personal protective equipment (gown, gloves, goggles, etc.) when working with
the analyzer.
9 Keep suitable devices (disinfectants, detergents, cloths, containers, solid/liquid suction
devices, etc.) at hand for the removal of any leaks of liquid or solid material, whether it may
be at risk of biological contamination or not. Have materials used to collect any leaks
disposed according to local regulations. Consult and keep safety data sheets (MSDS) handy
for information on the handling, treatment and disposal of liquid or solid materials,
substances, solutions, etc ...
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10 Keep suitable devices (disinfectants, detergents, cloths, containers, solid/liquid suction
devices, etc.) at hand to remove any solution leaks from the analyzer tanks (system solution,
waste liquid, detergent solution, washing solutions, etc.). Ensure that the materials used to
collect any leaks are disposed of according to local regulations. Consult and keep safety
data sheets (MSDS) handy for information on the handling, treatment and disposal of liquid
or solid materials, substances, solutions, etc ...
11 Do not use with or on the system any product beyond the expiry date or not included in the
Manufacturer's price lists (kits, reagents, solutions, controls, standards, calibrators,
consumables, etc...)
12 Slots and openings in the case, back panel, and bottom are provided for ventilation. This
ensures reliable operation of the system and protects it from overheating. Do not block or
cover these openings.
13 Before using the system, check that the voltage on the rear panel label matches the local line
voltage.
14 Do not replace the power supply cord if another with adequate specifications is not available.
In case of replacement, contact the Manufacturer to order a new power cord (see Ordering
Information)
15 To reduce power to the system, disconnect the power supply cord from the wall electric
power (unplug directly from the wall).
16 Ensure that the power supply cord is always easy to reach, to ensure a fast disconnection if
necessary.
17 To guarantee safety the system must be properly grounded. In case of doubts contact the
nearest qualified electrician. The wires in the mains power cordset are colored in accordance
with the following codes:
Green and yellow: earth
Blue: neutral
Brown: live
18 In case of need, replace fuse as marked (see Ordering Information). Prior to the removal of
any fuse, turn power off and unplug the cord from the wall.
19 Under no circumstances is this instrument case to be opened. This instrument is not user
serviceable, unless where stated in this manual. Dangerous high voltages inside the
instrument case. In event of difficulty, please notify your dealer for prompt service.
20 For operating safety, do not install the system in a location where it will be exposed to
heating equipment or radiators, direct sun light, or any other source of extremely high
temperatures.
21 Do not operate the system in the presence of flammable fluids or gaseous atmosphere,
disinfecting agents, cleaning agents, etc., due to possible fire or explosion.
22 Do not kink, bend, lay object on, or otherwise damage or restrict cables and tubes.
23 Be sure that the power switch of system is OFF when plugging in, or removing the power
cordset from a wall outlet.
24 Turn off the mains power switch whenever the system is not in use. This prevents damages
due to surge in the mains power.
25 Do not attempt to alter the shape of any part of the system.
26 if the system is not operating properly and the trouble-shooting section (Maintenance -
troubleshooting) does not provide a satisfactory solution to the problem, then do not use the
system until the defects are remedied.
27 Inspect all accessories and system cords. Do not use if damage can be seen such as cut
insulation or outer covering, frayed or broken wires, corroded or broken connectors etc.
28 To reduce the risk of fire or electric shock, do not allow fluids or any foreign object to enter
the system. Wipe off spills immediately.
29 Do not use benzene, thinner, any kind of solvents, or abrasive detergents to clean the case.
Clean with soft dusting cloth dampened with distilled water. If necessary use only neutral
detergent.
30 Do not stick objects of any kind into the system through back panel or case slots as they may
touch dangerous voltage points or short out parts that could result in fire or electric shock.
31 Install the system in such a way that adequate ventilation is provided all around to properly
dissipate the heat.
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32 Install the system in such a way that adequate space is provided all around to have easy
access and allow easy disconnection of all hydraulic, electric and electronic connectors.
33 Before operating the system, make sure that the waste probe is correctly positioned and
stable inside the waste container, that the water/detergent container is correctly placed and
stable, that all connectors (hydraulic and electronic, including the vacuum pump connectors
and tubes) all well inserted, that no electrical part or power cord may accidentally get in
contact with any liquid.
34 For operators' safety, do not operate the system if all covers are not in place (samples tray,
cuvettes tray, reagents chamber, …) and if the panels' and chassis fixing screws are not in
place.
35 The sampling arms have a special device that stops them in case of impact, to prevent
damages to the operator and the system itself. If lightly bumped, the arms will try to restart
their movement for three times, then the system will enter in fatal error. For these reasons it
is highly recommended to avoid any operation next to the moving arms.
36 Use only original Manufacturer's replacements. Do not use conventional tubing. This will
cause malfunction of the system.
37 Do not operate the system with any other liquid/solution/item other than those specified by
the Manufacturer and suitable for the specified use.
38 The system must never be used/operated with flammable substances/liquids.
39 The system must never be used/operated if flammable substances/liquids are nearby.
40 The system does not release dangerous vapors, if used under the manufacturer
specifications. When operating the system always wear suitable protective devices (gloves,
garment, eyes protective shield…) and follow the GLP precautions and warnings, for a safe
use.
41 Pay the maximum attention to avoid possible contamination and take all necessary safety
measures to avoid personal injury, risks for the environment, risks for the system, other risks
and biological contamination.
42 make sure all fluid lines are free of kinks, nicks, sharp bends, punctures, or occlusions before
installing on system.
43 As regards the moving parts in the analyzer, these have been appropriately protected to
avoid any potential risks to the user during the normal activity. When operating the
maintenance with cover in open position, attention must be paid to avoid the contact with
parts that the operator may have required to move.
44 If the system remains unused, empty the hydraulic circuit and make sure the system solution
and detergent containers are well closed. Dispose of the waste liquids in accordance to the
local regulations.
45 The halogen lamp must be replaced some minutes after the instrument has been turned off
and power cord unplugged (see Maintenance chapter)
46 When operating near the lamp, always wear UV-protecting glasses and personal protective
equipment.
47 Always allow the burnt out lamp to cool down before handling or attempting replacement.
48 Never touch the lamp or the reflector with bare fingers. Use a rag when changing.
49 If the lamp is touched inadvertently during installation, clean the lamp or reflector with alcohol
and dry with a clean, soft cloth before burning. Contamination of the lamp or reflector may
reduce lamp performance.
50 This lamp (when lit) emits UV (ultraviolet) radiation. Prolonged exposure to this lamp may
cause skin and eye irritation.
51 When opening the panels near the lamp, or when operating in the presence of the exposed lit
lamp, always wear UV-protecting glasses and personal protective equipment.
52 The analyzer system must not be dismantled or repaired by anyone who has not been
qualified by the Manufacturer. Incorrect work may cause fire or irreparable damage to the
system.
53 Do not overload accessories power outlets and extension cords as this can result in fire or
electric shock.
54 Do not place the system on an unstable cart, stand, or table; the system may fall, causing
serious injury to user, and serious damage to the appliance. Place the system on a stable,
vibration-free, level table or cart.
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55 Use only secure power source to protect the analyzer system against power surges.
Disconnect temporarily the analyzer power cord from the wall outlet in case of bad
atmospheric conditions.
56 do not oil any part of the system.
57 Empty waste containers whenever they are full. Ensure that the containers are
inserted/closed tightly to prevent leakage or dispersion into the environment.
58 The safe disposal of the analyzer waste material with minimal environmental impact is the
responsibility of the user and will have to meet the local laws and dispositions.
59 Do not attempt to remove any panels or coverings of the analyzer system while the system is
in operation.
60 After operation/servicing, cover the system with a protective plastic or cloth sheet.
61 When the system is not used, disconnect the power supply cord from the wall outlet.
62 Do not use software disks/usb mass storage or any other device of unknown origin in the
analyzer computer as they may introduce viruses.
63 Do not install in the analyzer's computer any software, except those required/authorized by
the Manufacturer.
64 The analyzers must not be internet-connected
65 The analyzers do not need any Operative System update
66 The analyzers are released from Factory virus-free and the Manufacturer cannot be
responsible for any virus or malware introduced after the release from factory.
67 It is responsibility of the Owner to grant the network to be safe when an analyzer is
connected to it
68 The modification of the computer settings (WINDOWS® THEME, DESKTOP, ETC..) may
cause system malfunctions. Do not change the settings released from the factory.
69 Do not use the computer of the analyzer for any other purpose than the one for which it is
designed by the Manufacturer.
70 Be particularly cautious that no parts of your body (e.g. fingers hair, etc.) or loose objects
(e.g. cables, tubing, etc.) can be trapped by any moving or rotating parts (e.g. sampling arm,
plates, washer module, pump rollers etc.) of the analyzer system.
71 System solution (double distilled water + surfactant)/detergent must be placed in an external
container (preferably on the floor under the analyzer) into which the supplied water tube is to
be inserted. The analyzer aspires the solution through a membrane pump. Do not connect to
hydraulic system under pressure.

NOTE:
the careful observation of the proceeding warnings should result in a long and satisfactory
performance. If the above-mentioned notices are not fully observed, then any form of warranty is no
longer valid and Biotecnica Instruments S.p.A. will not be responsible for any subsequent damage
or loss. (see warranty conditions).
the information in this manual is based upon the hardware and software currently in use. Biotecnica
Instruments S.p.A. reserves the right to make software and hardware changes or improvements for
product enhancement without notice and without imposing any obligation upon itself to install these
changes or improvements on its products previously manufactured.

WASTE DISPOSAL
To ensure environment health and safety, it is recommended not to discard the used consumables,
waste liquids or disposable maintenance kits into the environment.
Insure that the disposal of waste material is done according to all applicable laws and regulations.

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5. ANALYZER INTRODUCTION
This instrument is an automatic analyzer for Clinical Chemistry, I.S.E. and Immunoturbidimetry
manufactured by Biotecnica Instruments S.p.A. Rome, Italy.
The analyzer software is based on Windows 7 Professional operative system. The external PC
allows easy management of the operative system and of the stand alone operative program.
The software is easy to learn and offers the operator the maximum flexibility.
MAIN FEATURES
- throughput up to 240 tests/h
- I.S.E. alone, throughput up to 180 tests/h
- sequential access
- routine, urgent samples (STAT – Single Test in Actual Time) and batch programming
- calibrations and quality controls, immediate or time-programmable
- 18 normality classes: 3 fixed (male, female and children) and 15 editable
- dedicated auto-diagnostic function to help the operator in the maintenance of the analyzer
- operative 24h/24
- equipped with the solid state I.S.E. (Ion Selective Electrodes) module
- analytical parameters are flexible and open
- can work with up to four reagents, ready to use or concentrated
- every reagent can have its duplicate on board, for backup purposes
- refrigerated reagents chamber (40+40 positions) ensures a longer stability of the products in use.
- positive barcode identification of reagents and samples position reduces the possible errors
- repetitions (Re-run) upon operator's request or automatically (pathological and hyperactive results)
- sample pre- and post-treatment
- pre-analytical treatment of samples
- connection to the Host Computer
- internal software for managing quality control (statistics of control sera and population) and
patients’ archive with data display and printouts
- 60 positions sample tray (for cups, eppendorf or primary tubes) divided in 6 sectors of 10 positions
each + other 60 inner positions (cups or eppendorf only) for standard, controls and pre- treatment of
samples.
- auxiliary solutions in dedicated containers (three containers: two for sample dilution and one for
pre-treatment)
- reading tray of 64 circular 6mm special glass cuvettes
- one single cycle allows two dispensations per arm (two fixed phases – R1 and sample, two
variable phases – R2), two readings of the cuvettes and the related washings. The readings take
place every 15 seconds: one after the R1+S phase and the other after R2.
- washing is done in stages over several cuvettes simultaneously, each of which is subject to a
particular stage of washing
- sampling arms are equipped with a new mechanic for the detection of a crash and new devices for
quick movement of the needle for efficient mixing of reagents and solutions
- the samples arm has clot sensors and vacuum sensors which can monitor the operations of each
cycle of the machine indicating hydraulic malfunctions
- the control PC is connected to the analyzer via USB port. This allows to use external computers as
laptop or desktop with the specific settings of each country
The methods programming is fully open. The operator can program the mostly used methodologies,
which are already in memory, or brand new methodologies. The most common methods are: End
Point, Fixed Time, Kinetic, Sample Blank. It is possible to store up to 500 different test codes, plus
Relation Tests with no limit. In the stored analyses list the operator can generate customized test
codes sequence for the reagent tray in use, including the relation tests.

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6. BASIC OPERATING PRINCIPLES OF THE ANALYZER

The automatic analyzer is based upon the spectrophotometry principles.
The light absorption laws rule the performance of spectrophotometers.
The amount of light radiation that passes through a homogeneous absorbing medium is defined as
transmittance, T, where:
T = I / I0
I0 = incident light radiation intensity
I = transmitted light radiation intensity
The absorbance, A, (or extinction, E) is defined as:
A = log (1/T) = log I0/I
The Lambert-Beer law states the relation between absorbance, concentration of a compound
absorbing light and sample thickness:
A=εcd
ε = molar extinction coefficient of the compound absorbing light at a certain (λ) wavelength.
c = molar concentration of the compound absorbing light
d = optical path of the radiation into the solution
The absorbing spectrum of a compound is represented by a graph where the absorbed light (=
absorbance) is related with the wavelength. For a colored solution, the graph will show one or more
absorbance peaks. These may be in the visible part of the spectrum (400-700 nm) as in the
ultraviolet (200-400 nm) region.
The analyzer uses a photometric system specially designed by the R&D Dept. of the Biotecnica
Instruments S.p.A.
A light beam is sent through a cuvette that contains the solution that has to be read. The exiting light
beam is transmitted to a photometer containing 14 interference filters of different wavelengths. The
signal is amplified and then processed by the specific electronics and by the computer. The program
then makes all the necessary calculations and controls, so that it can finally present the
concentration of the compound in the sample and the any irregularities found in the reaction.
The general principle upon which the photometry in clinical chemistry is based is the following: the
increasing or the decreasing of the color intensity in a specific solution is proportional to the
searched compound concentration. Generally speaking, when a sample is added to a specific
reagent, it starts a reaction carried out by specific enzymes or substrates. This reaction causes the
increasing (or decreasing) of the solution color inside the cuvette. During the reaction process, the
instrument “reads” it by means of its absorbance. The final data processing is done with reference to
a calibration or a theoretical factor, so as to give at the end the concentration of the compound into
the sample.

The I.S.E. (Ion Selective Electrodes) module is a device dedicated to the determination in the
samples of the electrolytes (see chapter 11). This device is defined as ion selective as the used
sensors react with the corresponding ions in accordance with the following Nernst law:
E = E0 + RT/nF log aM+
aM+ = M+ ion activity
E = potential in Volt
E0 = constant (H+ electrode redox semi-reaction std potential)
R = gas constant
F = Faraday’s constant
T = temperature expressed in Kelvin degrees
n = ion charge
The sensors life is dependent upon the number of sample runs and the routine maintenance
procedures outlined in this manual.

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7. SYMBOLS: EXPLANATION OF THE USED OR APPLIED SYMBOLS

As the analyzer software is based upon Windows, it uses the Windows style, buttons, quick
commands, function keys and curtain-shaped menus.
Every screen has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up, the program will display the following main window:

Figure 1-1

① Main menu: each menu generates other commands and/or options

② Direct access buttons: selecting each button the relative command is directly activated
③Vertical Bar - Commands: Direct access to function commands
④ Program code: operative program software version
⑤ Access level: is the access level of the operator: it is password dependent
⑥ Messages bar: clicking here opens a window showing the messages received by the program
 Status bar: double click to open a window with the following information:
Ambient temperature
Cuvettes tray temperature
Reagents tray temperature
 Time and date

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BUTTONS BAR

Patients: gives access to the routine entry page

Batch: gives access to the batch entry page
Analyses: opens the analyses list with the analytical parameters for each test
Profiles: opens the profiles page
Tray: shows the reagents tray with volumes and related commands
Standard: allows calibrations programming and run
Controls: allows controls programming and run
Results: shows results per patient, calibrations and controls run
Results RT: shows results per test as soon as ready
Graph: shows the reaction graphs
Status: shows the analyzer (cuvettes status)

GENERAL BUTTONS

It is used to clear a page

It is used to delete

It is used to close a window

It is used to start a run

It is used to modify editable fields

It is used to enter into the print preview page

It is used to save data to the archive

As far as the analyzer program runs under Windows O.S., almost all Windows short-cuts are
available. For instance, in the editable fields it is possible to right click to copy and paste the text, or
it is possible to use CTRL+C to copy and CTRL+V to paste.

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IVD SYMBOLS: PRINTED PACKAGING ITEMS*

List of symbols and labels

Caution, consult instructions for use

In vitro Diagnostic Medical Device

Catalog number

Manufacturer Date of manufacture

Lot number or Batch code

Storage temperature

Expiry date

Biological hazard

Risk symbols

CE Logo (Directive 98/79/CE)

Caution: Cutting risk

Caution: Corrosive substances

Caution: Biohazard

Caution: Hot surfaces

Electrical and electronical devices: collect and dispose separately.

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A compilation of the main nameplate and warning symbols used for the IEC standards based on
Table 1 of IEC 61010-1 Second Edition.

Direct current

Alternating current

Both direct and alternating current

Earth (ground) Terminal

Protective earth conductor terminal

Frame or chassis (ground) terminal

Equipotentiality

ON (Main supply)

OFF (Main supply)

Equipment protected by double insulation or reinforced insulation

Caution, risk of electric shock (black on yellow background)

Caution, refer to accompanying documents
(black on yellow background)

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8. BRIEF DESCRIPTION OF THE SYSTEM

The analyzer is a compact instrument: in the upper protected part, there are the moving sampling
arms and the washing station. On the left side are the covers that give access to the samples tray
and the reagents tray. On the front there are the accesses to diluters and I.S.E. module. On the right
side, there are the unified waste pumps. Below the analyzer, the system solution tank, detergent
containers and waste containers are to be placed. A set of supplied fittings allows the use of
containers of various sizes.

8.1. Front view of the analyzer

Figure 1-2

1 ON/OFF BUTTON
2 ISE MODULE
3 REFRIGERATED REAGENT COMPARTMENT
4 SAMPLES TRAY
5 SAMPLING ARM SAMPLE (& I.S.E.)
6 SAMPLING ARM REAGENTS

7. Samples tray: primary tubes ring (and cups)

8. Samples tray: dilution cups ring
9. Reagents tray: reagents sector and bottles

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8.2. Rear panel

Figure 1-3

This label indicates all the items present on the rear side of the analyzer.
Read carefully the warnings and keep the air openings free to dissipate heat produced by the
analyzer.

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8.3. Modules
The analyzer is made up of three main blocks:
Analyzer main plane, intermediate drawers and containers base.

Figure 1-4

1. Reading station assy

2. Samples tray (rotating tray, bar-code, electronics), including Standards & Controls
3. Reagents chamber (rotating tray, refrigerating system, bar-code)
4. Samples arm assy (mechanical system, electronics)
5. Reagent arm assy (mechanical system, electronics)
6. I.S.E. module (sensors/electrodes, reagents, I.S.E. module)
7. Washing module (system solution and detergent)
8. Optical group
9. Dilutors

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CHAPTER 2
INSTALLATION
1. UNPACKING INSTRUCTIONS
The crates can be easily opened by applying the lever action, with a large screwdriver, to remove all
the spring clips at the base of the crate as shown in the figure below. Carefully remove the covering.
Remove the analyzer and place it on a stable vibration-free surface. Carefully unpack all the
accessories and place them in a protected place. Store the empty crate in a safe place for future
use.

Figure 2-1

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Verification of the contents of the wooden crates

Verify upon receipt of the analyzer system that all parts are present and intact when opening the
wooden crates and packaging. Please use Mod. 05_28spr, which is included in the shipment. This
document is specific for each analyzer and lists in detail which items are present in the packages.
The analyzer and accessories are contained in boxes adequate for the shipment.

Verifying eventual damages occurred during shipment

It is highly recommended to accurately verify the instrument and its accessories for any damages
that could have occurred during shipment. In case there is a damage or missing items then please
fill out all the sections of the Mod. 05-35a in this manual in the WARRANTY CONDITIONS. Send it
to your nearest sales/service office or directly to Biotecnica Instruments S.p.A. Rome, Italy. After
appropriate evaluation, Biotecnica or its branch office will provide the best solution to the problem.

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2. INSTALLATION
The analyzer and its derivates are IVD automatic analyzers dedicated to laboratory use only.
The analyzer should be easily accessible to allow the operator to load samples, consumables,
reagents, etc. Avoid exposure to direct light, heat, air streams and draught. The instrument’s left,
right and rear sides must be left free (min. 20 cm from the wall) to ensure the produced heat
dispersion and easy tubes and cables connection. Room temperature must not exceed 32°C. It is
very important to place the analyzer away from strong electromagnetic fields, such as centrifuges,
electric motors, big refrigerators, X-ray instruments, etc.
The analyzer refrigerator produces water condensation in the reagent chamber. This is important for
cooling the reagents in the bottles.
Warning: Please read and apply the warnings and precautions indicated in the first chapter of this
manual before continuing with the installation.
NOTE:
All the components, when present, shown in the following figures may undergo modifications over
the time. Therefore, it is recommended to verify them accurately prior to any repair or installation
(refer to eventual specific manuals included).

THE ANALYZER MUST BE IN OFF POSITION AND UNPLUGGED DURING

THE INSTALLATION PHASES.

2.1. Electrical connections

The analyzer and its PC must be connected to an UPS unit to avoid damages in case of electrical
spikes. This is important also to let the operator know when there is a power failure in order to take
the necessary actions.
Connect main power cable from the instrument to the UPS and connect the latter to the main wall
outlet. Power circuit should respect current laws and have a good earth connection.

The printer and peripheral devices should be connected to

the appropriate accessory power connectors on the analyzer
rear panel (adjacent to main power inlet) or to the UPS.
Laser printers should never be powered directly to the
analyzer.

Figure 2-2

2.2. External PC and peripherals connection

For the external PC, keyboard, mouse and printer installation, refer to the appropriate manuals.

The analyzer must be connected to the external PC by means of the

supplied USB cable.
One of the available USB ports on the PC should be connected to the
USB port on the right side of the analyzer.

The analyzer must be turned on (button on the rear side) before

loading the analyzer operative program.

Figure 2-3

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2.3. Fluidic connections

The analyzer has rear connection to four liquid containers: one for system solution, one for the
detergent solution, one for biological waste and one for clean waste. The containers should be
placed below the analyzer’s table.
On the rear panel there are the connectors to the analyzer’s
hydraulic circuit.
Refer to the analyzer’s rear label for details.

Figure 2-4

Figure 2-5

CAUTION: In case of malfunctioning liquids may spill on the floor by the overflow tubes.
These liquids do not show biological hazard. Carefully read Biotecnica’s solutions inserts for
information on the products.

SOLUTIONS USED (see also Chapter 16, Par. 2.2 for ordering information)

- SYSTEM SOLUTION: double distilled water + surfactant (see par. 3.1.3. Used
solutions/detergents for more details on solutions)
- DETERGENT SOLUTION: double distilled water + detergent (see par. 3.1.3. Used
solutions/detergents for more details on solutions)

NEEDLES
The needles are shipped separately from their arms, to prevent any damage. To assembly the
needles, just carefully screw them in place. The needles are different:

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The needles containers are identified with a dedicated label to prevent installing them in the wrong
way.
The arms are placed all way down in their home position. Lift the arms and remove the soft plastic
from underneath the arm head. Open the needles tube and screw each needle into ist arm head.

3. STARTING THE INSTRUMENT

Before starting the analyzer, make sure that the peripherals and the external PC are correctly
connected. It is advisable to connect the analyzer and the PC to the UPS. The other peripherals
may be connected to the analyzer accessory power connections as well as to the PC/UPS.

Before turning the analyzer on, it is necessary check the presence or to put in seat some items that
may be shipped separately.

DILUENT BOTTLES
The analyzer is equipped with three diluent bottles (50ml) for diluting the samples, placed at the
right of the sampling arms.

Figure 2-6

The three diluent bottles, for convenience, have been defined in the software
as follows:
 Saline solution
 Diluent
 Sample treatment
( I.S.E. sample diluent)
The operator can fill these bottles with any necessary working solution and
change the definitions as necessary (see Setup, chapt. 9 par. 2.4)

The I.S.E. 2P is usually in place. Only the electrodes and working solutions must be placed in their
own seats (see Chapter 11).
Before turning the analyzer on, verify also that all necessary parts are in place (covers, trays, etc…)

BLUE COOLANT
The blue coolant is usually already in place. It needs to be refilled. For instructions
and coolant code, please contact Biotecnica.

3.1. Turning on the instrument for the first time

Turn on the UPS device as described in the appropriate manual.
Verify that the PC and peripherals are turned on and that the PC is connected to the analyzer via
USB cable.

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Verify that the liquids (system solution and detergent) and the waste containers are in place.
Turn the analyzer on by means of the button on the rear side of the analyzer.
Load the analyzer operative program from the PC.

With the first start-up the analyzer will load also all microprocessors programming. This process will
take some minutes and it is performed only at the first start-up or in case of an upgrade.
The start-up process includes the loading of the operating system (bootstrap) into the memory. At
the end of the boot (loading of the operating system), the instrument activates all the devices and
performs mechanical, hydraulic and electronic checks.
Once turning on procedure has completed (lasting few minutes), wait for the system to warm up.
In the meanwhile, it will be necessary to perform a series of primes to make sure all the hydraulic
circuits are filled and there are no bubbles left. From the menu Analyzer, select Analyzer Utilities.
Alternatively, open the Special functions menu on the side bar and select Analyzer Utilities.
Perform the following:
- Needles prime
- Washing station prime

During warm-up phase the temperature indicator flashes on the bottom right of the display until the
appropriate temperature is reached. The instrument reaches the steady state after approximately 30
minutes (from switching the analyzer on).

3.1.2. Preliminary checks

Before using the analyzer, it is recommended to perform the preliminary checks outlined below.
Some of these checks should be performed daily and others are periodical.

DESCRIPTIVE TABLE

See Chapter 67, Par. 2.2. Consumables for product codes.

OPERATIVE CONTROL When

Verify system solution container Daily
Verify that there is sufficient system solution in the external tank for the needs of the working
day. The system solution is prepared by adding to double distilled H2O the Surfactant -
1ml per liter of water (i.e. ratio 1:1000). See technical specifications regarding double distilled
water in the next paragraph.
Verify the detergent container Daily
Verify that there is sufficient detergent solution in the external tank.
Verify the waste container Daily
Note: Check that the waste container is empty or that there is sufficient capacity for at least
containing system solution corresponding to the daily waste liquid volume.
Zeroing of the photometer (see chapter 10, par.
Twice a day
1)
Wash the cuvettes with the proper solution Daily
When: Before turning off or at the end of the working day (see chapter 10, par. 1)
Extra wash of the cuvettes with proper solutions Weekly
When: once a week (see chapter 10, par. 1)
I.S.E. wash Daily
When: once a day (see chapter 10, par. 1)

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3.1.3. Used solutions/detergents

See also Chapter 16, for ordering information

- SYSTEM SOLUTION: The product is prepared with 1000ml of double distilled water + 1ml of
Surfactant. Carefully read the product instructions. The solution has to be placed in the external
dedicated tank. It is used for the system washing of needles and cuvettes during working phases
and for the following functions: Wash cuvettes, Wash and fill up cuvettes, Zeroing on water, part of
the FCC procedure. The external tank should be replaced every time a new solution is prepared, to
avoid environmental contamination.

- CLEANING SOLUTION: Carefully read the product instructions. The product is ready to use and
has to be placed in a reagent bottle in the reagents tray. The solution is used for the following daily
functions: Shut down procedure (shut down wash of the cuvettes), daily cuvettes wash performed
with the Daily Wash Cuvettes procedure. A procedure with messages on the display will guide the
Operator to correctly place the solution. The reagent bottle should be replaced every time a new
solution is prepared, to avoid environmental contamination.
It is better to close the reagent bottle, remove it from the analyzer and store as indicated in the
instructions.

- DETERGENT SOLUTION: Carefully read the product instructions. The product is prepared by
adding 1000ml of Detergent Solution to 9000ml of double distilled water (1L bottle of detergent to 9L
of double distilled water). The solution has to be placed in the external detergent dedicated tank. It
is used for the system washing of needles and cuvettes during working phases. The external tank
should be replaced every time a new solution is prepared, to avoid environmental contamination.

- WASHING SOLUTIONS: Carefully read the product instructions. The products are ready to use
and have to be placed in reagent bottles in the reagents tray. The two solutions are used for the
following weekly function: Extra Wash Cuvettes. A procedure with messages on the display will
guide the Operator to correctly place the solutions. The reagent bottles should be replaced every
time a new solution is prepared, to avoid environmental contamination.
Always remove the solution bottles from the analyzer and store as indicated in the instructions.

DOUBLE DISTILLED WATER SPECIFICATIONS:

Resistivity: > 5 M Ω/m
Conductivity: < 1μS/cm
pH: 6,4
Residual Ions: < 1μg/l

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CHAPTER 3
FUNCTIONS
1. BASIC THEORY
The basic operating principles of the analyzer are described in chapter 1, par. 6.
The analyzer operates with fixed cycles of 30 seconds. Each cycle allows four dispensations: two
for R1+S and two for R2 + two reading phases (see chapt. 3, par 4.4). The cuvettes are
automatically washed with system solution and a special detergent solution to avoid possible cross
contamination.
Every test can be freely programmed, with the following limitations:
1. the first reagent is always inserted at cycle 1
2. the sample is always inserted at cycle 5 (120 seconds)
3. the minimum total cycles is of 6 (150 seconds)
4. the maximum total cycles is of 26 (750 seconds)

In the software, the programming of some of the basic test methods is already available (end point,
fixed time, kinetic and sample blank).
As far as every method can be freely programmed (with the above limitations), it is very easy to
create all possible tests using the already available formulas.
For instance the end point test formula is:
Point[Final]-Blank, i.e. the analyzer will use the last cycle absorbance subtracted of the blank
absorbance.
For what concerns the reagent blank, it can be read on the same cuvette used for the reaction. In
this case every sample will have its own blank. On the other hand, it is possible to perform the
reagent blank on a separated cuvette. In this case, the reagent blank will be calculated on the basis
of a specific formula, that can be for instance Point[Serum-1], i.e. the analyzer will use as blank the
cycle before the sample insertion (see chapt. 3, par 4.4).
For all those tests in which the reaction starts with the sample insertion (R1, then R2, then Sample),
the blank can be performed on the same cuvette as the test. For the tests in which the reaction
starts with the second reagent (R1, then Sample, then R2), it will be necessary to perform the blank
in a second cuvette.

The analyzer works with couples of cuvettes. At the beginning of every working session, the
analyzer will wash the first series of cuvettes, then it will go on washing until the last sampling. If in
the run there are only I.S.E. tests, the analyzer will anyway start a the first washing series. The
cuvettes wash is performed in a sequence that starts with the aspiration of the cuvettes content and
the dispensing of detergent solution, followed by the rinsing with system solution and drying of the
cuvettes.
Once the cuvettes are washed, the sampling starts, using the cuvettes in couples. After the
reagents and sample dispensing, the analyzer will wait the end of the incubation and reading times,
will acquire the absorbances for the results calculation and will then wash again the cuvettes so that
the cycle can continue. The analyzer can work 24h/24, therefore the samples can be loaded
continuously.
The test results are then displayed in the real time results pages. In the Results RT page, the single
results are displayed as soon as ready, while in the Results page, the results are displayed as soon
as the whole patient is completed. Then results can be printed or saved into the Archive.
All results, archives pages as well as reaction graphs can be also saved as *.pdf files. Archives can
also be exported in *.csv or *.rtf formats.

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The calibrations, as well as the Quality Controls, have dedicated archives. The QC has also a real
time archive where the controls results can be verified in real time.

In the analyses programming page, there are the analytical parameters, the standards and the
controls. In the same page it is possible to display only the tests on line or all the tests.
The position of the reagents, as well as the positions of the standards or controls on the tray are
programmed in different dedicated windows.

Samples can be programmed in Routine mode (which includes running of STATS or controls) or in
batch mode.
In Routine it is possible to select the type of sample (serum, urine, CSF or other) and eventually the
automatic pre-dilution. Batch runs can be performed on serum or on urine.

Before every run, it is possible to perform a reagents volume check (the analyzer will present the
question) to allow the analyzer to use the backup reagents.

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1.1. Methods description

End Point
Once the sample has been added to its reagent, a reaction occurs first causing a variation in the
solution’s color i.e. the absorbance, followed by a phase in which the reaction’s color is stable,
defined as "plateau".
Generally, the absorbance value (A) is read at the beginning of the plateau or is the first point after
the incubation time. This value is then multiplied by the factor computed during calibration, to obtain
the concentration of the analyte in the sample.
Conc. in sample = Factor x (Final absorbance - Reagent Blank)

Figure 3-1

Fixed Time
In this type of reaction, there is an increase (or decrease) of the absorbance during both
incubation’s and reading’s phases. However, the slope of the line may not be the same during the
two phases. The reaction graph displayed to the user is not always linear, but can also appear as
piecewise linear. During reading time, the absorbance delta (∆A) is computed, which is used for
calculating the final concentration for the analyte in the sample.
Concentration is calculated by multiplying the absorbance delta by the factor obtained from the
calibration:
Conc. in Sample = Factor x (Abs delta)

Figure 3-2

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Kinetics
This kind of reaction is very similar to the previous one, with the difference that the reaction and the
graph derive both from the computation of regression lines. The regression line for the reading
phase is then scaled to minutes to compute absorbance delta (∆A/min.). This value is then
multiplied by the factor to compute the concentration of the analyte in the sample:

Conc. in Sample = Factor (Abs delta)

Figure 3-3

Sample Blank
This method is used whenever it is required to eliminate the photometric interference of the sample
(for example turbid sera) from the reaction. These are double-reagent End Point reactions. The
reaction and the computation are performed during two distinct phases: in the first phase (sample
blank) the reaction between the first reagent and the sample (R1+S) takes place, while in the
second phase the second reagent is added to R1+S (R1+S+R2). The final absorbance used for
computing the concentration of the analyte is obtained from the difference in absorbance between
the two phases:
Conc. in sample = Factor x {Abs(R1+S+R2) – [Abs(R1+S) x k]} where k is the volumetric factor

Figure 3-4

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2. DESCRIPTION OF THE PROGRAM MENU

The analyzer operative program is built to work under Windows O.S., therefore it works with the
same philosophy. The access to the operating commands is possible trough menus and icons.

There are five main menus: Patients, Analyses, Analyzer, Utility and Archives.

Patients
Routine/STAT Management & Batch Management: these commands
are used to enter samples in Routine/STAT and Batch mode.
Delete Work list: deletes the entire memorized patients list. The analyzer
will request confirmation before deleting.

Analyses
Parameters: with this command the analyzer will open the analyses page
where it is possible to enter and program new analyses or to modify the
existing ones.
Manage Reagents: this icon gives access to the reagents map, where it is
possible to create the on-line map and to have general information on reagents,
such as residual volume, position, lot number and expiry date.
Profiles: is used to create the analyses lists (profiles) which can be used for
programming patients.
Manage Standard: gives access to the standard page, where the standard
positions and lot number can be viewed. From this page it is possible to run
calibrations.
Manage Controls: gives access to the controls page, where the assigned
positions and lot number can be viewed. From this page it is possible to run the controls.
Export: copies in any desired location, the analytical parameters, optionally with the profiles and the
analyses tray. There are two available options: Back-up (for exporting all the analyses) and Single
Test (exports a selection of single tests).
Import: copies the above-mentioned parameters from any location into the analyzer memory. There
are two available options: Restore (will import all parameters) and Single test (imports the exported
single tests).
NOTE: when a back-up is imported, all data will be overwritten. When a single parameter is
imported, it will be placed in the list of available analyses, not in the "in tray" list. The operator will
have then to correctly place it in the analyses tray.

Analyzer
Mechanical Calibrations: gives access to the page dedicated to the
mechanical devices adjustment (arms and trays).
Analyzer Utilities: this command opens a page where the operator can
select to perform one or more of the available utilities, such as washing the
cuvettes or zeroing the photometer.

Diagnostic: this line gives access to further options as viewing the FCC or the optical transmission.
It also gives access to the general diagnostic page, which is normally used only by the well-qualified
technical assistance personnel.

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Utility
Setup: it is used to define the system parameters, such as the language,
the communication, the bar-code, etc. This command is disabled during
analyzer operation.
View Reaction Graph: this command displays the reaction’s curves on a
graph, with all reaction information and print capability.
Suspend Activity: this function can be used to switch the analyzer
partially off and let it turn on automatically at the desired date and time.
The analyzer will display a window where
it is possible to enter the desired date
and the time. Once the selection is made,
click on Accept. The analyzer will ask for
the washing of the I.S.E. and of the
cuvettes. Follow the instructions to proceed. Then the analyzer
motors, lamp and cuvettes heating will be turned off, while the
refrigerators will remain on. One hour before the desired time expires, the turned off devices will turn
on again for the pre-heating phase. At the desired time the analyzer will fully turn on and the users
log-on window will be displayed.
Log-Off: this command is used for logging off and on the different users. When logging off, a
window will appear where the user must enter the user name and password
Switch-off analyzer + PC: with this command it is possible to turn off the analyzer program
together with the PC operative program. The analyzer itself will remain turned on. Press the
ON/OFF button to turn also the analyzer off.
Note: The analyzer’s program will guide the operator through screen messages in the analyzer
turning off procedures. He will be invited to place the solutions when needed and to ensure the
correct execution of washing procedures. Bear in mind that it is not possible to ensure data
precision and accuracy if the normal washing and maintenance procedures are not observed.
Serial: this option allows the analyzer to send data to the host computer, upon operator’s request.
The type of data transportation can be selected in the Setup.
Log Files: this read-only area is very important for the Technical Assistance/service personnel.
Under this option there are the following:
- View Logs: gives access to the files where the operations performed by the analyzer are stored,
together with the logged users.
- View Test Counter: in this page it is possible to view the total of the tests performed by the
analyzer, divided into blanks, controls, standards, etc.
- Lot's management: shows all the reagents' lots with the expiry dates. The positions on the tray,
as well as if the reagent is the 1st or 2nd are not displayed.

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Archives
This menu gives access to all the archives: patients archive, population
archive, quality control archive, calibrations' archive and real time QC
archive. The latter gives information in real time on the performed
controls.

MAIN ICONS BAR

In this bar are presented the most common and most useful icons.
Opens the routine programming page

Opens the batch programming page

Gives access to the analyses analytical parameters, standard and controls

Opens the profiles programming window

Gives access to the reagent tray pages (volumes information, make tray function)

Opens the page for programming positions and running standards

Opens the page for programming positions and running controls

Opens the real time results page (per patient)

Opens the real time results page (per test)

Gives access to the reaction graphs pages

Gives information on the analyzer status.

Figure 3-1 Analyzer Status

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2.1. Printing interface

In many parts of the analyzer program it is possible to find a Print function. The Print button will
open a printing interface, which allows many different choices.

Click on the printer icon to print the document. The printer interface will allow the operator to select
the printer, the copies, the number of pages, etc….

Figure 3-2
Click on the "paper " icon to export the document in different type of file formats. The available
file formats are:
*.pdf => will save the document as Adobe document.
*.rtf => will save the document in rich text format. This can be opened
with Word, Notepad, Wordpad, etc…
*.csv => will save the document in comma separated values format.
This can be opened with Excel. The older versions of Excel will
correctly open (in columns ) these files only following this procedure.
Open Excel, the click on "Open" or "Open a file". In the "Open" window
select "All files (*.*)" at the line "File type". Then browse for the *.csv file and open it.
Text (matrix printer) *.prn => will save the document in a text file for dot-matrix printers.
HTML file => will save the document as *.html file (web page).

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Click on the Adobe icon to export the document directly to *.pdf.

The analyzer will open the Export to PDF interface and
then will allow the operator to save the file in any
location in the HD.

Figure 3-3

Click on the "binoculars" icon to find a text in the open document.

Figure 3-4

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3. APPLIED MATHEMATICAL FUNCTIONS

Correlation Coefficient

∑ (T
n
− T )( Li − L)
CC = 1 i
n n

∑ ( Li − L) 2 ∑ (Ti − T ) 2
1 1

where:
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings

Linear Regression

n n

n ∑ ( Li ) 2 ∑ (T ) i
2

∑ (T L ) − n i i
1
n
1
n
M= 1
n

n 2 (∑ Ti ) 2
∑ (T )
1
i − 1
n

n
 n n

∑ Li  n

∑1 Li ∑ T  i
1
− ∑ (Ti Li ) − n 1

n  1 n n 
 
Q=  
M
where:
M : Angular coefficient for the line
Q : Final point for the line
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings

Distance point-line

D =| Y − MX − Q |

where:
M : Angular coefficient for the line
Q : Final point for the line
X : Point Abscisse
Y : Point Ordinate

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Distance between two points

X − x0
Y= ( y1 − y 0 ) + y1
x1 − x0

where:
X : X axis
Y : Y axis
x0 : First Point X Axis
x1 : Second Point X Axis
y0 : First Point Y Axis
y1 : Second Point Y Axis

MATHEMATICAL FUNCTIONS FOR CLINICAL CHEMISTRY

Volumetric factor (used in sample blank tests)

K=
∑ R1 _ Volume + Sample _ Volume
∑ R1 _ Volume + R 2 _ Volume + Sample _ Volume

Sum of (reagents + sample) volumes (at cycle 5)

Sum of all (reagents + sample) volumes

I.S.E. Module Functions, see I.S.E. dedicated chapter.

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3.1. Initial Computation

The initial computation is important for transforming the microprocessor data into compatible data
for the program to generate the single absorbance value, which will be used afterwards for the final
absorbance computation.

Clinical Chemistry

 F − Fz1 
Z − Log  1 
 F2 − Fz2 
V= Op
Of
where:
Z : Zeroing with water
F1 : First Filter’s Value
F2 : Second Filter’s Value
Fz1 : First Filter’s Zero-Value
Fz2 : Second Filter’s Zero-Value
Op : Optical path
Of : F.C.C.

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4. HOW TO PROGRAM THE ANALYSES

The analyses programming page can be accessed from the main menu (Analyses) or from the
specific icon that gives direct access (Analyses) to the Analyses Management page.
To set out new analyses it is necessary first to create the code and then to assign the parameters,
the standards and the controls.

The analyzer can store virtually endless analysis codes (with parameters). It is possible to view only
the analyses which are on the tray (Only in tray), only the analyses which are not on the tray (Only
not in tray) or all programmed codes (All Codes). To create the working tray it is possible to use
the Make Tray command in the Reagents Management window (Tray icon).

4.1. Creating a new code

Open the analyses management page and select New. Enter the test’s code
and select the test type between Clinical Chemistry and Relation (click on
the button ""). The test type defines whether the programmed test is a
Clinical Chemistry test or a relation test (mathematical computation). Use
the button Save to memorize the test, or press Cancel to exit and abort
programming. Any code can be deleted by using the Delete option in the
Utility menu of the Analyses management page.
For every code the Parameters, Standard and Controls pages are opened
together. Click on the corresponding tag to change among these pages.

4.2. Relation tests

Once the code has been created, the relation test will be placed in the All Codes list, but it will be
automatically moved into the Only in tray list, after having moved to the tray also the analyses
belonging to the formula.. Select the code by clicking on it (it becomes red, bold and underlined) to
program its general parameters and the related mathematical function. The Parameters page is the
first displayed.

Figure 3-5

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In the General parameters page enter the following information:

Name: complete test name
Units: measurement unit.
Primary: write the primary measurement unit.
Secondary: write here the secondary unit, if necessary. In the Factor field, write the conversion
factor from the primary unit to the secondary one.
Limits: insert the min. and max. values of the normal range with reference to the selected group
(male, female, etc).
Decimals: here it is possible to decide whether to use the floating point algorithm (see par. 5.5) for
the decimals in the results, or to have them fixed. In this last case, disable the Automatic check and
set the number of fixed decimals desired (max 3).
Instrumental Factor: this function introduces a constant correction of the final data of the
calculated test. It may be used for making adjustments to test data obtained from analytical methods
or different type of instruments. Calculation: final result = value x instrumental factor
Shift: this function introduces a constant quantitative correction of the final data. It may be used for
making adjustments to test data obtained through analytical methods or instruments of different
types. Calculation: final result = value + shift.
To enter the mathematical function select Formula

A window divided in two parts will be displayed: one for the calculator and one for the analyses list.
The mathematical function can be composed of simple values and operations or can recall sample
results acquired by the analyzer on other tests (complex function). To enter a simple mathematical
function avail yourself of the displayed calculator. To enter a complex function, select the code of
the test to be inserted into the function. A small field will appear, where it is possible to select the
type of sample (among serum, urine, CSF and Other) result for that test. Then complete the function
with the needed operations.
To create more complex functions (involving more than one test’s result) it is advisable to use the
parenthesis as for all normal mathematical functions. Ex. For the creatinine clearance with urine/24h
= 900ml [(urine CRE x urine ml 24/h)/(serum CRE x 1440)] the formula would be: ( [CRE&U] * 900) /
([CRE&S] * 1440).
NOTE: use only the numbers and symbols on the screen, by clicking on each and remember that
the same operators on the keyboard are disabled.

NOTE TO RELATION TESTS: when running samples with relation tests, bear in mind that all tests
that are present in the relation test formula will be automatically assigned to that sample, no matter
if the same is a master, a clone, a repetition or a normal sample. In any case, the analyses in the
formula are assigned to the patient and performed again. Only in case the same analyses are
already assigned to the patient, these will not be assigned twice. The analyses are assigned
accordingly to the sample type (analyses on serum to serum samples, analyses on urines on urine
samples), therefore, for a relation test having both analyses on serum and on urine, it will be
necessary to create a Master patient for serum and a Clone patient for urine, both having the same
relation test programmed (see also Chapt. 5, par. 4.2.1).

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4.3. Introduction to the clinical chemistry tests

Open the analyses management page and select New. Enter the test’s code, select the test type
Clinical Chemistry and save. Once the code
has been created it is possible to program its
parameters. The newly created code will be
saved in the All Codes list. To move it to the
working tray it is possible to use the Make
Tray command in the Reagents Management
window (Tray icon)
In the analyses list click on the code and the
parameters window will be displayed. In this
window there are three tags: Parameters,
Standard and Controls. Each tag gives access
to dedicated pages. The Parameters page is
the first displayed. The analyses programming
is fully described in the next paragraph.

Figure 3-6

There are some commands which are in common for all the analyses and these commands are
available in the menu bar.

Print menu. From this menu it is possible to print the analytical parameters, the calibrations and the
controls. It gives access to other choices: it is possible to print the actual test, the selected tests (if
more than one test is checked) or the whole area (depending on the area that has been visualized:
only in tray, only not in tray or all codes).
Utility: with the options in this menu it is possible to Rename an already created test and Delete
one or more selected codes (with all parameters). To select a test code it is necessary to click on
the checkbox near the code and put the check sign. In this menu it is also possible to Import and
Export parameters.
Export: copies, in any desired location the analytical parameters (with standard and controls),
optionally with the profiles and the analyses tray. There are two options: Back-up (for exporting all
the analyses) and Single Test (exports a selection of single tests).
Import: copies the above-mentioned parameters from any location into the analyzer memory. There
are two options: Restore (will overwrite the present parameters and import all parameters, the
profiles and the analyses tray – if these information were exported) and Single test (imports the
exported single tests). When importing the Single test, these will not be place in the analyses tray:
the operator will have to set again the reagents positions, bottles volumes, etc.

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4.4. Calculation and use of cycles

In each cycle of the analyzer two readings and two dispensations will take place (two fixed phases –
R1 and sample, two variable phases – R2), plus two readings of the cuvettes and the corresponding
washings. Readings take place every 15 seconds: one after R1+S and one after R2. Dispensations
are timed to 30 seconds.
As a consequence, the dispensing cycles must be calculated one every 30 seconds, while
the reading cycles must be calculated one every 15 seconds.
This difference is very important and must be kept in mind when writing formulas or entering times.
NOTE: the sample insertion cycle, set at the 5th cycle, corresponds to 120 seconds, as there is no
'0' cycle

CYCLE DIAGRAM

The dispensing of R1 and Sample are the ‘fixed phases’ as in these phases the analyzer is also
washing the cuvettes and therefore cannot move the tray. The dispensing of R2 is, instead, free
from the cuvettes wash.
In the formulas, the pre-set functions must be used, always considering that:
1. the intervals in the cycles graphs (times) correspond to 30 seconds
2. any point inserted with a numerical value corresponds to a 15 seconds interval

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In this example, the cycles intervals correspond to

30 seconds.
Cycle #10 corresponds to 9x30=270 seconds (bear
in mind that the first insertion cycle - R1- is not
cycle zero, but cycle #1).

Examples of functions and readings in formulas:

Point[LastInsert], considering the above picture, corresponds to cycle #10, therefore to 270
seconds. The corresponding reading will take place in the 15 seconds immediately after the last
element of the reaction has been added in cuvette.

Point[Sample-1], again considering the below picture, corresponds to cycle #5 (120 seconds), minus
1, which is 15 seconds, therefore the analyzer will read at a total of 105 seconds.

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5. ANALYSES PROGRAMMING
The first page shown is the Parameters page. In this page there are
five buttons: General, Reaction, Sample, Check and Supplementary.
Each of these choices opens a different dedicated page. For the
I.S.E., see chapter 11.

Figure 3-7

5.1. GENERAL
In this page the operator must give some general information on the test.
Putting the check in the bar-code checkbox, the bar-code field will be displayed. By means of the
Bar-Code it is possible to assign a numerical code for positive identification of the reagents. It
enables, if activated in the Setup, the bar-code scanning to correctly identify the bottle during
reagent’s insertion phase.
Method: write in this field the reaction principle used for the test (for example: Jaffè, IFCC, etc.).
This option is useful when recalling the tests from the Quality Control archive, in accordance with
different principles.
Filters: the operator can select the desired filter value for the Filter 1 and the Filter 2 (normally
used as reference filter) from the available filter wavelengths.
The analyzer and its derivates have the following available wavelengths: 340, 380, 405, 436, 478,
510, 546, 578, 600, 630, 660, 700, 740, 800 and Ref.
For the tests in dichromatic, click on the Filter 1 and select the desired filter from the cascading
window and then go to Filter 2 and select the desired filter from its cascading window.
For the tests in monochromatic, select the desired filter in the Filter 1 cascading window. Since the
second filter is not used in this type of test, therefore select the last position, Ref, in the cascading
window of Filter 2. In this case the analyzer will use a reference filter only to stabilize the readings.
Process: defines the kind of test’s calibration: with factor, linear, or with curve. The following
choices are available: cubic spline, polynomial, best fit, multi points, log-logit 4, log-logit 5 and semi-
log.
linear: this function is used for linear reactions, it requires analytical test calibration to process the
computing factor;
with factor: it is used for linear reactions whenever the computing factor used is theoretical;
with curve: non-linear tests, distinguished in:
cubic spline: the typical cubic interpolation is used. There is a good connection between subsequent
point couples. Approximation is perfect on single points, but is not flex point free;
polynomial: a third degree polynomial function is used. It has a very good approximation, but
sometimes it may show anomalies;
best fit: a second or third degree polynomial interpolation is used. It gives the best approximation to
the minimum squares. It is a very simple curve, but sometimes may be distant from the standard
points;
Multi-point: Linear interpolating function for several standard concentrations (max 6);

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log-Logit 4 and log-Logit 5. It is a logarithmic approximation on four or five points, used for non-
linear tests;
Semi-log: a second degree curve is used, which is function of the concentration logarithm, and gives
the best approximation to the standard points minimum squares. It is asymptotical on the last point,
has no flex points and well approximates the standard points. It may be used for highly non linear
processes.

NOTE: check the Standard curve inverted for those curves where the absorbance decreases as
the concentration increases (see also par. 5.3 Samples and at the end of par. 6 Calibrations).

Always bear in mind that the serum parameters will be used for the calibrations, regardless of the
sample that is going to be used.

Analyses With Factor

Calibration executed by the analyzer is not required for these tests, but a theoretical factor for
calculation needs to be entered. This is a parameter to convert the absorbance values (ABS),
determined by the analyzer, in final concentration values. A box appears where it is possible to
enter a known factor value, declared in the method.

Analyses with Linear Calibration

In this type of test the analyzer executes a calibration with a known concentration standard. Based
on the absorbance values detected for the standard, the analyzer calculates the factor, which will be
used to convert the absorbance values (ABS) of samples to final concentration values. After each
new calibration the analyzer calculates and updates the factor. Alternatively, it is possible to directly
enter a known value in the Factor field.

The used calibrators or standards must be placed in the positions assigned in the
page Manage Standard.
In linear analysis it is possible to use up to 6 different standard concentrations or execute up to a
maximum of 6 repetitions on a single point. It is possible to program the same positions for various
analyses if a multi-calibrator is used.
In analyses with curve, the standard positions available are:
- cubic, polynomial, best fit, multi point and semi-log 3 to 6 positions.
- log logit4: 4 positions
- log logit5: 5 positions

Multipoint calibrations
In the multipoint calibration it is possible to make multiple replicate of one of the calibration points.
To replicate one point it is necessary to give the same concentration to multiple positions. The
analyzer will calculate the mean absorbance for those points and will use it as a single point.
Example:
Point 1 2 3 4 5 6
Concentration 100 100 200 200 300 400
Abs 0.010 0.012 0.020 0.022 0.030 0.040

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For the above example, the analyzer will create a graph with four points being:
Point 1 2 3 4
Concentration 100 200 300 400
Abs 0.011 0.021 0.030 0.040

Inverted standard curve: check this option for those analyses in which the absorbance decreases
as the concentration increases.

Use only odd/even cuvettes: these functions can be used to avoid cross contamination between
two tests. One can be programmed in even cuvettes, the other in odd
cuvettes. In this case the throughput will decrease as the analyzer
needs to work with couple of cuvettes, while this function splits the
couples and uses single cuvettes.
ATTENTION: When the odd/even cuvettes are selected, but the sample is to be diluted in the
cuvette (Sample management dilutions), the use of the separate cuvettes in the run-test phase is
automatically disabled, because the predilution does always take place in one cuvette, while the
following is usedfor the actual reaction

5.2. REACTION
In the Reaction page the operator must give those parameters that are necessary to define the
reaction, from the number reagents, to the type of calculation to be used for the test itself.

5.2.1. REAGENTS
Number of reagents: enter the number of reagents the methodology requires, max. 4. Use
up/down arrow keys "" or move the cursor directly on the box and enter the value. Remember that
the number of reagents is the only parameter that must be defined before moving the test into the
on line tray.

Figure 3-8
The selected number of reagents will appear at the page base with one tag for each reagent. For
every reagent the operator must enter the following information.

Reagent Quantity (µl): insert the volume of each reagent (in micro liters) by selecting the
corresponding table (Rgt 1, Rgt 2, Rgt 3 & Rgt 4) in accordance with number of reagents
programmed. Always bear in mind that there are some limits for the final solution (reagent +
sample) as well as for sample or reagents (for limitations see table 1 at the end of par. 5.3).

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Dilution: this field refers to concentrated reagents. If ready-to-use reagents are used the Type field
should be set to None. If the reagent has to be diluted, in the Type field it is necessary to select
Diluent. Then insert in the Diluent Quantity (µl) text box the volume of the diluent to be added to
the concentrated reagent. For example: for a dilution ratio of 1:3 write 100µl for the concentrated
reagent and 200µl for the diluent. The dedicated diluent is considered by the analyzer as a further
reagent and will therefore take a position of its own in the reagents’ tray.

In case the test is already in the tray, selecting the dedicated diluent will cause the test to be
removed from the tray in order to program the position for the dedicated diluent.

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5.2.2. TIMES
The times are expressed in cycles. Every cycle is 30 seconds.
The max number of programmable cycles is 26, corresponding to 750 seconds.
As far as the reagent 1 and sample insertion cycles are fixed (respectively to cycle 1 and cycle 5),
the only programmable times are for the total reaction time and the other reagents insertion.

Figure 3-9

One single cycle allows two dispensations per arm (two fixed phases – R1 and S, two variable
phases – R2 and following), two readings of the cuvettes and the related washings.

End Cycle: use the arrows to enter the final cycle of the reaction.
Reagent 1 & Sample: these fields are fixed as the first reagent's and the sample's cycles are fixed
by the program, respectively at the first and fifth cycle.
Depending on the number of reagents, the following fields will appear.
Reagent 2, Reagent 3 and Reagent 4. In these fields it is necessary to enter the number of cycle at
which the corresponding reagent must be introduced in the reaction cuvette. Using the mouse
cursor, click on the arrows until it reaches the correct value. In case of cycles overlapping with other
reagents, the cycle number will become red, and in case of overlapping with sample cycle, the
number will become red on yellow background.
NOTE: in every reagent cycle it is possible to insert two reagents. If one of the reagents is diluted,
the reagents become three, so it will be necessary to move the insertion of one reagent to the next
semi-cycle. The sample cycle allows the insertion of the sample and of two reagents.

5.2.3. REACTION

Figure 3-10

Calculation type: the type of calculation may be quantitative, qualitative or mixed: a combination
of these two. Select the desired calculation and, except for the quantitative calculation, enter the
cut-off value. In the qualitative calculation, the patients results will be expressed as <[cut-off] or
>[cut-off].
In the mixed calculation, results will be expressed as <[cut-off] when below the cut-off and with the
numerical value when above the cut-off. Bear in mind that the stored results (all archives) will
always be a numerical value.

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Formula: the final absorbance, to be used in the result concentration calculation, will be calculated
on the basis of the given formula. It is possible to select one of the already present calculations, or it
is possible to introduce brand new calculations. Use only round parenthesis when entering the
formula, as the square parenthesis are used by the program for the already available formulas.
For instance, an End point test formula will be: Point[Final]-Blank, thus meaning that the analyzer
will use the last read point absorbance subtracted of the reagent blank. A Fixed time test formula
will be: Point[Final]-Point[LastInsert+X], thus meaning that the analyzer will calculate the delta
between the absorbance read at a point after the last insertion cycle (defined by the methodology)
and the absorbance read at the final point. The same formula could be written Point[Final-X]-
Point[LastInsert].
When using the cycles, bear in mind that the analyzer will, in the same cycle, perform the insertion
first, followed by the reading phase. The reading phase will always be the last thing performed in a
cycle.
Clicking on the f(x) icon, it is possible to display the available Functions or the
formula parameters (Help).

Figure 3-11
Generally speaking, the formula can contain the following elements:

Blank: reagent blank value

Point[X]
[X] definition "X" meaning
[LastInsert] absorbance read at the last insertion cycle
[Final] absorbance read at the final cycle
[n] Number of the corresponding semi-cycle (15sec). Where min. n=1
IMPORTANT: numerical values correspond to semi-cycles, therefore
to intervals of 15 seconds

Eg:
Point[LastInsert]: uses the absorbance read when the last item (reagent or sample)
was introduced in the reaction
Point[LastInsert-1]: uses the absorbance read 15” before the last item (reagent or
sample) was introduced in the reaction
Point[Final]: uses the absorbance read at the final cycle of the reaction

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Regress[Lastinsert, Lastinsert+2], with the same definitions as above for ’n’: is the linear
regression calculated from the insertion point of the last reagent to the same point +2 semi-cycles of
15 sec.
RegrxMinute[Lastinsert, Lastinsert+2], with the same definitions as above for ’n’: is the linear
regression calculated per minute, from the insertion point of the last reagent to the same point +2
semi-cycles of 15 sec..
Mean[Lastinsert, Lastinsert-3]: with the same definitions as above for ’n’: is the mean value
calculated from the insertion point of the last reagent to the same point -3 semi-cycles of 15 sec.
Sample: uses the absorbance read in the same cycle when introducing the sample in the reaction.
Reagent[n]: uses the absorbance read in the same cycle when introducing reagent number "n" in
the reaction.

Other elements that can be added to the formula are:

µlSerum: indicates the sample volume in µl
µlReagent[n]: indicates the reagent "n" quantity in µl
These elements can be used for instance for calculating the volumetric factor when needed.

The reaction formulas already present are:

End Point: Point[Final]-Blank
Fixed Time: Point[Final]-Point[LastInsert+1]
Kinetic: RegrxMinute[LastInsert+1,Final]
Sample Blank: Point[Final]-(Point[LastInsert-1]*VolumetricFactor)

The "0" or “1” in the formula must be changed by the operator with the necessary number of semi-
cycles (reading cycles of 15”).
These formulas are only examples and should be used only as guidelines to start the reaction
programming. The above mentioned formulas may also be different from the presented ones.

When programming formulas, bear in mind the absorbance sign that is expected for the calculation.
This and other info will be very important when programming the checks page.

Note on the Shift and Slope functions: these two functions are to be used only in those analyses
responding to the following conditions:
Process is Multi points
Standard points are only two (also if duplicated) and have different concentration.
Under these conditions, the final result is not calculated by means of the calibration factor, but by
means of a straight line, using in the formula its slope and shift.
For instance, an End point test formula under these conditions would be:
(Point[Final]*Slope+Shift) - Blank
In all other cases, with the exception of the above mentioned, and including standards, the slope
and shift will have respectively the default values of 1 and 0.

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Some examples of applied formulas are in this chapter appendix.

NOTE: the Volumetric factor formula is:

K=
∑ R1 _ Volume + Sample _ Volume
∑ R1 _ Volume + R2 _ Volume + Sample _ Volume

Sum of reagents + sample volumes (at cycle 5)

Sum of all reagents + sample volumes

The Blank volumetric factor formula is:

Kb =
∑ RGT _ Volume
( Sample _ Volume *1.16 + 16) + ∑ RGT _ Volume

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5.2.4. BLANK

Figure 3-12
This page is dedicated to the reagent blank calculation. As for the final absorbance in the test, also
the blank must be calculated by means of a specific formula.
The reagent blank, when performed in the same cuvette where the reaction will also take place, will
be automatically read for every single sample. The blank can be read in this way when all of the
reagents needed for the calculation of the reagent blank are dispensed into the cuvette prior to the
sample (prior to cycle 5) and no more than 4 incubation cycles are required between the reagents
themselves. The formula can be written: Point [Sample-1], that means reading 15” before
dispensing the sample. The absorbance value of the blank is then displayed in the reaction graph.
In the standard page will only be displayed the last blank read.
Use another cuvette: click on this checkbox to let the analyzer use a second cuvette for performing
the reagent blank. This option is useful every time the blank must calculated with a dynamic
different from the sample, or when the reagent blank must be calculated with reagents that are
inserted after the sample. In this case it is necessary to introduce the formula for calculating the
absorbance. The formula is based on the same criteria as the one for the reaction.

Figure 3-13

End cycle: use the arrow to select the number of the last cycle to be used.
Reagents used: use this option when more reagents are used for the test, considering that not all
of them are necessary to calculate the reagent blank. Just select by means of the checkbox the
reagents that participate to the blank calculation, then move the corresponding arrows until the
correct insertion cycle is displayed. In case of cycles overlapping with other reagents, the cycle
number will become red.
Repetition: when the reagent blank is performed in the same cuvette as the test, it does not need
to be repeated as it is read for every sample, but when it is performed in another cuvette, the
operator should decide when to perform the reagent blank reading.
The reagent blank, depending on the reagent itself, may need to be performed once a week, as well
as every four hours, for instance. This option gives the possibility to select when to perform the
blank.

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Every run: the absorbance determination for the reagent will be performed at every work start-up
for the analyses that are going to be run.
Every day at: the absorbance determination for the reagent will be performed every day at the
specified hour. For example, setting "03" "15"
determination will be performed every day at
03:15 in the morning.

Days + hours interval: the absorbance determination for the reagent will be performed at the time
intervals as programmed into the Days +
Hours boxes. For example, setting "02 + 8"
determination will be performed every two
days and eight hours. Setting "00 + 8" the
blank determination will be performed every eight hours.

Every "n" samples: the absorbance determination for the reagent will be performed every "n"
samples. For example, setting 15, the analyzer
will perform the reagent blank at the first and
every 15 samples. In a work-list of 50
samples, if the 16th sample is missing, the
th
bank will be moved to the 30 sample. Alternatively, the blank will be performed at the first sample
of the next run.
If the reagent blank is programmed in another cuvette with respect to the analyses and there is a
lack of sample, the blank is not completed, it is flagged with the No serum flag (S) and forcedly set
to 0.0.

5.3. SAMPLE

Figure 3-14

This page is dedicated to the sample parameters, necessary for the reaction. At the bottom left of
the page there are the four tags with the various type of samples: serum, urine, CSF and Other.
The "Other" tag is left free for any other type of sample that the operator will use. For every type of
sample, it will be necessary to fill the fields described below, in order to allow the analyzer to
correctly perform the necessary calculations and to use the correct references.
Name: write here the full name of the test. The name written here will be used in the real time pages
and in the final report. DO NOT ENTER THE SAME NAME FOR DIFFERENT TESTS TO AVOID
CONFUSION IN REPORTS.
Quantity (µl): write the sample volume, expressed in µl.

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Limits: the limits that have to be selected here are the normal range and the panic range, each
defined for every group: male, female, children and the other 15 available groups that have been
defined in the Setup (see chapter 9, par. 2.1 ).
Group: select the desired group for assigning the ranges.
Normal values: enter the minimum and maximum values for the normal range of the selected
group. All results falling within this range will be considered as normal and will not be flagged.
Results below the minimum or above the maximum, will be considered as pathological and will
be flagged with "-" and "+" respectively.
Panic values: enter the minimum and maximum values of the panic range for the selected
group. Extremes are not included. All results falling within this range will be simply considered as
pathological and will not be repeated when pathological repetition is active. Results below the
minimum or above the maximum, will be repeated if the pathological repetition is active (and the
sample result is not inside the normal range). In this case, samples can be automatically
repeated with or without dilution. Attention: the pathological repetition criteria are selected in the
sample page, but the check and the automatic repetition are selected in the Check page.
Use only undiluted sample: the analyzer will always use the whole, undiluted sample from the
samples tray external circle. This option allows the sampling, for the selected test, to be performed
on the whole sample, even if in the patient’s data the special preparation (sample pre-dilution) is
active (in case of sample treatmet with lysing solution, this cannot be applied).
The type of sample treatment is set in the Sample management page, explained hereafter.
Sample management: the sample can be pre-diluted as well as post-treated. The sample handling
performed after the first result of the test (post-treatment) can be a sample dilution or a sample
"concentration". The sample pre-treatment, which is the only automatic pre-dilution, is applied to all
samples undergoing the test. It is also possible to program the pre-dilution of a single sample, but
this can be done in the Routine programming of the sample. See also Note on the samples
management with special preparation and pre-dilution at the end of the paragraph and the
Special preparation in chapt. 5, par. 4.2.1.
First it is necessary to select the type of treatment, then to set the correct treatment parameters and
to activate the sample management by clicking the Active checkbox. This procedure will only
activate the sample management parameters. Then, to allow the analyzer to perform the
corresponding check and eventually the repetition, it will be necessary to separately activate also
these other options (see par. 5.4).

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Example
Sample Parameters:

Check Parameters:

The analyzer will perform the pathological check (with respect

to the panic values), but the automatic repetition is not active.

The analyzer will perform the pathological check and if

necessary, the automatic repetition with the above parameters.

The different types of sample management can be

selected, and the corresponding parameters set,
one by one. The Pre-treatment, the Pathological
High, the Hyperactive and Out of curve Above
will give place to a sample repetition with dilution.
The Pathological Low or Out of curve Below will
give place to a "concentration" of the sample.

Pre-treatment: this parameter is set when all samples need a pre-dilution and this is the only type
of pre-treatment, as all the other options are treatments performed after the first sampling result and
are activated only in certain conditions. See also Note on the samples management with special
preparation and pre-dilution at the end of the paragraph.
Pathological High: when a result is higher than the max value of the panic range, it may be useful
to repeat it with dilution.
Hyperactive: when a result is hyperactive (out of Test Limit, Max Abs Delta and/or Final Abs), it is
necessary to repeat the diluted sample in order to bring the absorbance back into the linearity
range.
Out of curve Above: in analyses with non linear calibration, the absorbances falling out of the
calibration curve may be misinterpreted. For this reason, it is necessary to dilute the sample and
repeat the test.

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Dilution: the preparation of the diluted sample may be performed with water, i.e. system solution
(from the reservoir) or any other diluent as
necessary. The type of diluents can be edited
in the Setup page (see chapt. 9, par. 2.4) as
every lab may need different and specific
diluents. The default diluents are defined as
follows: saline solution, diluent and sample
teatment. Select the Type of solution to be
used, then write in the corresponding fields the
Sample volume and the Diluent volume. These two volumes will be mixed in a dedicated cuvette
from which the analyzer will withdraw the sample volume as set in the sample Quantity field. This
diluted sample will then be used for the reaction. The minimum volume for Sample+Diluent is 120µl.

For instance, setting the parameters as follows:

Type: saline
Sample volume: 30µl
Diluent volume: 90µl

Sample Quantity 16µl

The analyzer will dilute 30µl of original sample with 90µl of saline solution (1:4), then will
withdraw 16µl of the diluted sample for performing the reaction. The read absorbance
will be then multiplied by 4 to give the final result already included of the performed
dilution.

The minimum volume for Sample+Diluent is 120µl if the Sample Quantity is less than 120µl. If the
Sample Quantity is more than 120µl, the minimum volume for Sample+Diluent would be "Sample
Quantity" + 5µl.

Pathological Low & Out of curve Below: in case of a result below the minimum panic range or
below the minimum point of the calibration curve, it may be useful to increase the sample volume to
bring the sample absorbance back into the range or the curve. Pay attention that in this case the
reaction stoichiometric ratio will be changed.
Enter the Sample volume to be withdrawn in place of the volume set in the Quantity field.

The analyzer will calculate the multiplication factor (which will be <1) in order to correctly calculate
the result.

For instance, setting the parameters as follows:

Original Sample Quantity: 2µl
Sample volume: 4µl
The analyzer will take 4µl instead than 2µl of sample, then will read the absorbance.
The result will be then multiplied by 1/2 to give the final result already included of the
performed "concentration".

ATTENTION: when enabling the pre-dilution in the patient acquisition (in routine), all the
sample treatments in the Sample Management will be ignored. If the pre-treatment (lysing
solution), instead, is enabled, the Sample Management options will be used.

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SAMPLE MANAGEMENT FOR INVERTED CURVES

In the analyses with inverted calibration curves, the absorbance increases as the concentration
decreases, therefore the sample management has to be different. When a sample is below the
calibration curve, it must not be "concentrated" as in normal analyses, but its absorbance will be
high and it will be necessary to dilute it. The opposite will happen for a sample above the calibration
curve.
The Pre-treatment programming remains unchanged: it will allow the sample pre-dilution by
selecting the sample and diluent volumes.
The other treatment parameters will change as shown in the following table.

Normal calibration curves Inverted calibration curves

Pre-treatment Dilution Dilution

Pathological High Dilution Sample increment

Pathological Low Sample increment Dilution

Hyperactive Dilution Sample increment

Out of curve Above Dilution Sample increment

Out of curve Below Sample increment Dilution

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SUMMARY OF THE SAMPLE MANAGEMENT

Sample management Action Check to activate Flag
Before sampling
Pre-treatment pre-dilution
After sampling
Pathological High dilution Pathological +
Pathological Low concentration Pathological -
Hyperactive dilution Test limit I
Max Abs Delta d
Final Abs A
Hook H
Out of curve Above dilution Out of curve Above >
Out of curve Below concentration Out of curve Below <

NOTE ON THE SAMPLES MANAGEMENT WITH SPECIAL PREPARATION AND PRE-

DILUTION
When pre-dilution from Routine in Patient Entry (Special Preparation) is enabled, the pre-treatment
in the Analytical Parameters - Sample Management is ignored. If, however, the Use undiluted
sample (in the Sample Parameters Settings page) option is enabled, the Analyzer ignores the
Special Preparation from Routine (performed in a dedicated cup) and applies only the pre-treatment
set in the Sample Management. This type of programming is useful for those patients who need to
be pre-diluted, i.e. they must perform all the given assays with a certain pre-dilution. In this case it is
convenient to have a dedicated cup where to pre-dilute the sample and then perform the sampling
from this. However, if the same sample is also assigned with analyses that have a pre-dilution other
than that set in patient entry, for these it is possible to enable in the Sample Parameters the Use
undiluted sample option. In this way, only for the selected analyses, the analyzer performs the pre-
dilution (in cuvette) only from the whole sample and not from the already diluted cup (prepared
according to the Special preparation) (for more info, see Chap. 5, par. 4.2.1)
When the pre-treatment (lysis) is selected in the Patient Entry (Routine), the treated cup will be
considered as primary cup, therefore any sampling will be performed from the inner circle cup.
The sample pre-treatment (lysis) can be programmed only in the Patient Entry window.

INDICATIVE VOLUME LIMITS – Table 1

Min Max
Sample volume 1.8* 200
Reagent volume 1.0 380
Reagent diluent volume 1.0 380
Reagent + diluent volume 180 380
Volume in cuvette (reagents and sample) 180 380

SAMPLE MANAGEMENT
Sample 1 200
Diluent 1 300
Sample + diluent 120 300
The minimum volume for sample + diluent in sample management is
"Sample quantity" + 5µl when the Sample quantity is higher than 120µl
* it is advisable to use a minimum of 2µl of sample
NOTE: all preparations, including calibrations dilutions, sample pre- and post-dilutions, etc, are
performed in cuvettes tray.

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5.4. CHECK

Figure 3-15

The check parameters page contains a list of checks that are necessary and useful to verify the
correct reaction evolution and end.
As for the other parameters, there is the possibility to set the checks in different ways for serum as
well as for urines, CSF and other liquids.

In the Check list there are two columns: on the left side there are
the checkboxes to activate the automatic repetitions, on the right
side there are the checkboxes to activate the checks themselves.
On the right side of the page there are the check tags, one for each
check. Click on the tags to set the parameters for every control that
the analyzer will have to perform. Once the limits have been set for
one of the sample types (for instance "serum"), it is possible to copy
the same information to the other sample types by clicking on the
Copy these data to other types button (when the displayed page
is the one for the already programmed sample type).

Reagent Limit
The reagent limit verifies the good quality of the reagent.
For every test it is possible to set an Upper limit and a Lower
limit. Usually for an increasing reaction it may be expected that the
reagent blank increases, while it may decrease for a decreasing
reaction. In some cases it may be useful to set both upper and
lower limits. If the reagent’s absorbance is beyond these limits, the
analyzer will check the results with O flag (Reagent out of limit).
This parameter allows monitoring reagents quality, as well as
checking any variation from the specific techniques.

Note:
This control has the highest priority on all the other check flags and inhibits the automatic repetition
functions. In case of reagent out of limit, the blank will be repeated every time the test is performed
in a run.

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Final Abs Sign

This check verifies the sign of the final absorbance as calculated with the
Reaction Formula. For instance a decreasing fixed time test will have a negative
sign if the delta is calculated as (Point[Final]-Point[LastInsert+1]), but if it is
calculated as (Point[LastInsert+1]-Point[Final]), it will be positive. All depends on the way the
formula is written. In case of discrepancy between the programming and the calculated abs, the
result will be flagged with ! (exclamation mark). Keep in mind that, by definition, the delta is always
calculated between the last point and the first one, in this order. As a result, the delta of a
decreasing analysis will be negative and an increasing analysis’ delta will be positive.

ATTENTION: in decreasing tests formula, the final absorbance is usually negative. In this case it is
absolutely necessary to set this control, to put the Final Abs Sign as negative and to enable the
check. This because the internal default value for this check is positive. If the check is not enabled
and the final absorbance sign is negative, the results will all be <NC> and flagged with (--) which
means negative concentration.

Form
This check is performed at three levels: reaction form, reaction direction and tolerance within the
previously selected options.
Select the kind of absorbance variation to be verified during reaction.
First of all select the Reaction type among Straight line (kinetic and
fixed time), Logaritmic (End point) and Exponential.
In a Straight line reaction, the analyzer is expecting the absorbance
points to be distributed approx on a straight line. The user can enter a
tolerance in %, that will prevent the analyzer from giving an error every
time there is a small variation in the reaction points.
Tolerance %: at the end of the reaction the analyzer calculates the
correlation coefficient in percentage among the points of the reaction. If
the tolerance is set to 100%, the analyzer will accept every variation and no flag will be given. If the
tolerance is set to 10%, the analyzer will accept a correlation coefficient of 0.9 or 90%.
In a Logaritmic reaction, the analyzer is expecting the final reaction points to be distributed approx
on a flat line. In an Exponential reaction the analyzer is expecting the reaction points to increase
after a relatively flat starting. In this case (both end point and exponential), the Tolerance (mABS)
is expressed in mAbs. After the last dispensing cycle the analyzer will verify the delta read between
every two readings (one cycle). The calculated delta should be consistent: always>0 or always<0
(depending on the reaction direction).

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In case the delta calculation results in an inverted sign, the analyzer will verify whether this inverted
delta is within the stated tolerance. If not, the result will be flagged with F.

Figure 3-16
In the above example, the delta are always increasing up to point o, then the two couples p-q and
q-r have a decreasing delta. The delta calculated for the two couples must remain within the given
tolerance.

Test Limit
This parameter is used in all methodologies and it allows verification
of the final concentration of the analyses. It represents a threshold
value beyond which the analyzer detects an out-of-linearity condition
(hyperactivity). The concentration should be expressed with the same units used for the standard.
When the test result exceeds this value, the analyzer will flag the result as hyperactive (I flag =
Hyperactive Sample – out of Test Limit). If the Repeat check is enabled, the analyzer will also
automatically repeat the sample with the criteria expressed in the Sample Management page for
hyperactive situations.

Max Abs Delta

The Max ABS Delta represents the maximum
acceptable delta, expressed in mABS, calculated
during the reaction.
This parameter is calculated with the Formula
entered in the dedicated field. When this parameter
is exceeded, the analyzer will flag the result as
hyperactive (d flag = Hyperactive Sample – out of Max Abs Delta). If the Repeat check is enabled,
the analyzer will also automatically repeat the sample with the criteria expressed in the Sample
Management page for hyperactive situations. The Max Abs Delta is usually verified in the first phase
of the reaction. The reaction starts when adding the sample or when adding the last reagent,
therefore in terms of formula, it is possible to establish a delta between the Point[LastInsert] and
another point 60" or more, after it. For instance, the formula can be Point[LastInsert+4]-
Point[LastInsert].

Sample Interference
The sample interference is used to verify whether there is any
interference in the absorbance reading due to the sole sample (ex.
lipemic sample). The reading is performed after sample insertion,
therefore at cycle 7. The absorbance expected for this cycle is supposed to be a sum of the reagent
absorbance + a normal sample absorbance. If the absorbance read exceeds this value, the sample
will be flagged with i flag.

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Hook
In this check the analyzer verifies the whole reaction with relation to
the reaction direction. The analyzer will verify the delta read between
every two readings (one cycle). The calculated delta should be
consistent: always>0 or always<0 (depending on the reaction direction). In case the delta
calculation results in an inverted sign (delta<0 in an increasing reaction or delta >0 in a decreasing
reaction), the analyzer will keep in memory the absorbance of the first inverted absorbance delta
point. Then it will go on calculating the delta between every couple of readings until the delta is
inverted again. The analyzer will then calculate the total delta between the first inverted absorbance
delta point and the last one, when the absorbance delta is again normal.

Figure 3-17

In the above example, the Hook will be calculated between points o and r. If this delta exceeds the
given value, the result will be flagged with H flag (= Hyperactive Sample). If the Repeat check is
enabled, the analyzer will also automatically repeat the sample with the criteria expressed in the
Sample Management page for hyperactive situations.

Final Abs
This check verifies the final reaction absorbance (upper limit for
increasing analyses, lower limit for decreasing ones). If the set
absorbance is exceeded, the analyzer will detect an out-of-linearity
situation and will flag the result with A flag (= Hyperactive Sample – out of Final ABS). This check
can be selected only if also the Form check is selected, this to allow the analyzer to know which is
the reaction direction. If the Repeat check is enabled, the analyzer will also automatically repeat the
sample with the criteria expressed in the Sample Management page for hyperactive situations.

Pathological
The results falling outside the normal range are flagged with + if above the range and with – if below
the range. The pathological check will verify if the results fall within the normal range.
If the Repeat check is enabled, the analyzer will also automatically repeat
the samples outside the panic range, with the criteria expressed in the
Sample Management page for Pathological situations.

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Out Of Curve Above

With this check, the analyzer verifies the absorbances falling outside the calibration curve on the
high side. The corresponding results will be flagged with > flag.
If the Repeat option is enabled, the analyzer will automatically repeat the sample with the criteria
already selected in the Sample Management for the out of curve above condition. If, after the
repetition, the absorbance is still outside the calibration curve, the result will be flagged with >> flag.

Out Of Curve Below

With this check, the analyzer verifies the absorbances falling outside the calibration curve on the low
side. The corresponding results will be flagged with < flag.
If the Repeat option is enabled, the analyzer will automatically repeat the sample with the criteria
already selected in the Sample Management for the out of curve below condition. If, after the
repetition, the absorbance is still outside the calibration curve, the result will be flagged with << flag.

NOTE 1: the available checkboxes must be enabled to allow the analyzer to correctly flag the
results. If programmed but not checked, the analyzer will not perform any check. Only for the Final
Abs Sign the analyzer will use the internal default value, Positive, thus giving the wrong flag in
case of negative Abs and the result would be <NC> (!).

NOTE 2: when the Repeat check is enabled, but the corresponding Check is not, the automatic
repetition does not take place.

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5.5. SUPPLEMENTARY
The supplementary parameters are used to define the measurement units, the decimals, the
instrumental factor and shift.

Figure 3-18
UNITS: the measurement units will be used to report the sample's final result in the correct
concentration unit. Enter for the Primary unit the Dimension. The units may be the same as used
for the standard or may be different. In this case it is necessary to enter the Std Conv. Factor,
which is a factor by which the concentration, calculated with the standard units, will be converted
into the Primary unit.
For instance:
The standard is expressed in mmol, the desired dimension is in µmol. The analyzer must be
programmed as follows:
DIMENSION [µmol] - STD CONV FACT [0.001]
The relation is:
STD DIMENSION X STD CONV FACT = RESULT DIMENSION
If necessary, a second unit can be used. In the Secondary part, check Present, then enter the
secondary unit dimension and a multiplication factor to convert the primary unit into the secondary.
In the Decimals field it is possible to decide whether to use the floating point algorithm for the
decimals in the results, or to have them fixed. In this last case, disable the Automatic check and set
the number of fixed decimals desired (max 3).
Principle of the floating point:
for values like 0.XXX three decimals
for values up to 9.XX two decimals
for values up to 99.X one decimal
for values over 100 no decimals

The Supplementary parameters must be programmed for every type of sample independently.
For instrumental factor and shift, see the Relation tests.

NOTE ON URINE UNITS

Many chemistries are run on serum and also on urines. The calibration is normally performed with a
standard or calibrator which has the same dimensions of the serum.
The urines dimensions may be different and are in any case linked to the urine/24H volume. These
two factors must be verified and, if necessary, used to correctly calculate the results.

Example 1: units are mg/dl both for serum and for its calibrator. For urines the dimension is mg/24h.
This value is calculated as follows:
mg dl
( sample) x (diuresis )
dl 24 H => mg/24H

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therefore if the diuresis is given (see patient entry – see chapter 5 par. 4.2.1.) in dl, the dimensional
equation will turn out correctly. But if the diuresis is given in a different unit, such as liters, the
dimensional equation must be corrected and the same is for the Std Conv. Factor.
(dl=l*10)
mg lx10(= dl )
( sample) x (diuresis ) => 10 * l/24H => the correction factor is 10.
dl 24 H
Example 2: units are mg/dl both for serum and for its calibrator. For urines the dimension is g/24h.
This value is calculated as follows:
(mg=gr*0.001)
grx0.001(= mg ) dl
( sample) x (diuresis ) => 0.001 * g/24H => the correction factor is 0.001.
dl 24 H
To print the analytical parameters, go to the menu bar, select print and then select what to print.
The printout is updated only if parameters have been saved.

NOTE: When the following parameters are used at the same time: Instrumental factor and Shift (in
secondary analytical parameters), External dilution factor and Urine 24/h (in the patient’s data), the
calculation made by the analyzer will be as follows: [(test result x External factor x Instrumental
factor) + Shift] x Urine 24/h

ATTENTION: if the calculation of the result (with instrumental factor and shift) gives a value less
than zero, <NC> (not calculable) will be displayed instead of the result and the associated flag will
be M: Error in the parameters (instrumental factor and shift): By opportunely correcting the
instrumental factor and shift parameters and running the calculation again (with the Adjust
function) it is possible to convert the <NC> result to a valid number.

5.6. AUTOMATIC REPETITIONS

As already seen, some check parameters can be used to perform the repetition of the test under
specified conditions.
These parameters are:
- Test Limit I
- Max Abs Delta D
- Final Abs A
- Hook H
- Pathological High +
- Pathological Low -
- Out of Curve Above >
- Out of Curve Below <
In case more than one of the above listed flags occurs at the same time on the same test, there is a
priority list that the analyzer will follow to perform the repetitions.
Below is the list, starting from the highest priority:
- Hook H
- Out of Curve Above >
- Out of Curve Below <
- Test Limit I
- Max Abs Delta d
- Final Abs A
- Pathological High +
- Pathological Low -

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6. CALIBRATIONS
The calibration parameters are accessible from the same page of the analytical parameters,
selecting the Standard tag.
The standard parameters must be programmed for all type of processes: with factor, linear, with
curve, to allow the analyzer to correctly calculate the results on the basis of the read absorbance.

PROCESS WITH FACTOR

According to the analytical parameters, the calibration may be linear or with
curve. It is also possible to calculate the result by means of a theoretical
factor. In this case, in the analytical parameters the process selected should
be With Factor. In these type of analyses the standard page would be as
the one presented here on the right. In the Factor field, simply type the
value of the theoretical factor that the analyzer will use to calculate the final
result for the test. The Last Blank field is updated by the analyzer with the
latest reagent blank read.

LINEAR PROCESS
The analyses with linear process will display a standard page as the following.

Figure 3-19

Factor
In the Factor section there are three fields that must be programmed.
Value: in this field the analyzer will automatically update the factor value calculated in the calibration
(the factor is the mean value among the single factors, each one calculated for one standard).
Min: enter the minimum acceptable value of the calculated factor.
Max: enter the maximum acceptable value of the calculated factor.
The Min and Max factor fields are necessary to verify the validity of the calibration. In case of out of
range factor value, a warning is given and the calibration is not saved, keeping the previously
memorized factor.

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Calculation: if known concentration and absorbance values are available, it is possible to

mathematically process the factor using the Calculation button.
The Last Blank field is updated by the analyzer with the latest reagent blank read (this might be a
standard as well as the last sample read).

Standard: in this section it is possible to program the standard parameters, but not
the standard positions on the standard tray. This setting is possible only from the
Manage Standard page.

Figure 3-20

N. of points: select the number of points to use in the calibration, from 1 to 6.

When assigning the positions on the tray's standard positions to the standards, remember that
every standard has a sequential number that corresponds to a certain concentration. The same
sequential number is present also in the Manage Standard page, to allow a correct positioning of
the cups.

Figure 3-21
Serial dilution: if desired, a serial dilution can be
automatically performed by the analyzer. Type the
concentration value of the highest standard in the
Conc field, then select a serial dilution value, ex.
1:2. The analyzer will automatically update the other
Conc fields with the serial concentrations and the
Dilution 1: fields with the corresponding dilution
ratio. This parameter is only necessary to perform
calculations and update fields. To activate the serial
dilution, see below (Automatic Serial Dilution). When opening the standard page again, after saving
the changes, the Serial dilution field will be again set to 1:1, while the Dilution 1:… field will
maintain the dilution ratio that will be used for future calibrations.

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Diluent type: if the serial dilution has been programmed, select also the type of diluent to be used
for the standard dilution. Bear in mind that the diluent solutions names are user-defined (see Setup,
chapt. 9, par. 2.4).
Dilution 1: : if the standard is diluted, but not serially, it is possible to assign the specific dilution
ratio in this field, together with the corresponding concentration in the Conc fields.
Conc: the standard concentration that the analyzer will use to calculate the factor must be typed in
these fields.
ABS: the absorbance read by the analyzer, for every standard will be updated in these fields.

AUTOMATIC SERIAL DILUTION: the automatic serial dilution is always performed directly in
cuvette, therefore there is no need to put three cups on the tray's standard positions. Only the
highest standard must be placed on the tray. The serial dilution is automatically activated when, in
the standard parameters page, the dilution ratio is different from 1:1.

Standard parameters page

Std#1 Std#2 Std#3
Dilution 1:1 1:2 1:4
Manage Standard page
Automatic pre-dilution performed by the
Case A Tray pos. A1 A1 A1 analyzer in cuvette taking three times the
standard from pos A1.
Automatic pre-dilution performed by the
analyzer in cuvette taking the standard from
Case B Tray pos. A1 A2 A3
position A1, then from position A2 and then
from position A3..

ATTENTION: the dilution ratio (both Serial dilution 1: and Dilution 1: ) allows the
use of the floating point. It is therefore possible to type a dilution such as Dilution
1: 3.22. The arrows will increment or decrement by 0.5.

MULTIPLE STANDARDS: when more than one standard is used, its position on the tray's standard
positions must be defined in the Manage Standard page. In the following example it is possible to
see that the analyzer can take the standard three times from the same cup or one time each from
three different cups.

Standard parameters page

Std#1 Std#2 Std#3
Dilution 1:1 1:1 1:1
Manage Standard page
No pre-dilution. The analyzer will take the
Case A Tray pos. A1 A1 A1
standard three times from pos A1.
No pre-dilution. The analyzer will take the
Case B Tray pos. A1 A2 A3
standards from the three different positions.

Use sample pre-dilution: enable this check if you want the analyzer to pre-dilute the standard in
the same as it pre-dilutes the sample (see par. 5.3 Sample – Sample management – Pre-treatment)

Variance %: this parameter allows the good quality of the calibration verification. It represents the
acceptable difference (in percentage) among the factors calculated if various standards are used or
if replicates are executed on a single point. After a variation above the programmed limit, a warning
is given and the previously memorized factor is not changed.

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Last Calibration: in this field it is updated the date for the last positive
calibration performed for the test.

The calibrations have a dedicated archive (menu Archives – Calibrations' Archive) where all the
performed calibrations are stored. Here it is possible to view whether the calibration had a positive
result or not and the type of error. The calibrations that had problems of no reagent or no standard
are not stored.
Calibrations can also be time-programmed in order to let the analyzer remember the operator when
to run them. This feature is in the Manage Standard page (see chapt. 5 par. 3.1).

NON LINEAR PROCESS

See also chapt. 5, par. 3.1.3.
Non Linear analyses require from 3 to 6 standards. In the analyses with Log logit 4 & 5 curve,
programming is the same but the required positions are 4 and 5, respectively.
Select the number of standards to be used to construct the curve. The fields for entering the dilution
and concentration of the various standards appear automatically. The values in the ABS boxes are
automatically updated during the calibration phase, if known they can be entered by the operator.
Programming is similar to that for analyses with factor.
To use the standard pre-dilution function, program the standards and enter the calibrator
concentration (the most concentrated point of the curve) at the first position. Then click in the Serial
Dilution box the desired dilution ratio.

Figure 3-22

The analyzer will automatically calculate and update the scalar concentrations starting from the
highest concentration value already present in the fields. In the Dilution fields the dilution ratio will
be automatically updated for each point.

ATTENTION: the dilution ratio (both Serial dilution 1: and Dilution 1: ) allows the
use of the floating point. It is therefore possible to type a dilution such as Dilution
1: 3.22. The arrows will increment or decrement by 0.5.

Zero: used to automatically reset the concentration of the lowest point of the curve to zero. The
analyzer will dispense the saline solution in this position. In case the analyzer finds in the same
calibration parameters, more than one point with the same concentration, dilution and position as
the zero point, it will automatically consider it as another zero point.

Use sample pre-dilution: some analyses are programmed with the automatic sample pre-dilution.
It is possible to use the same pre-dilution also for the standards. The standards will be diluted as set
in the Sample Management page at the Sample pre-treatment option.

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Clicking on the button Graph the analyzer will display the calibration graph for the test.

Figure 3-23

For all the tests with calibration curve, the

analyzer will warn the operator if samples
(patients) have results above or below the
calibration curve. The associated flag, next to
the result, will be: below curve "<" and above
curve ">". It is possible to select automatic re-
running of samples outside the calibration curve
in the Check parameters (see par. 5.4)
considering also that the repetition parameters
are set in the Sample Management page.

Figure 3-24

ANALYSES WITH INVERTED CURVE

Some analyses may have an inverted calibration curve.

Figure 3-25
As the concentration decreases, the absorbance increases, therefore, the highest concentration will
have the lowest absorbance. For these tests, the Sample Management parameters must be dealt
with in the opposite way (see par. 5.3).

To print the calibrations, go to the menu bar, select print and then select what to print.

Calibrations as well as controls can be programmed in order to let the analyzer remember to the
operator when a timed repetition is necessary. The programming is performed in the same pages
where the physical positions for the standards & controls are assigned: Manage Standard pages
(see chapter 5, par. 3.1).

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IMPORTANT: the calibrations can also be programmed to be partially performed with automatic
dilution (therefore directly diluted in the cuvettes) and partially to be withdrawn from the cups in the
standard positions (see chapter 5, par. 3.1.3.)

7. CONTROLS
The controls are divided into Known and Unknown. For every type there are three levels.
Known: Level 1, 2, 3
Unknown: Level 1, 2, 3

Figure 3-26

Enter the Lot ID# both for known and unknown controls, then complete the fields for the known
control, assigning the minimum, theoretical and maximum values of the lot in use.

To print the controls, go to the menu bar, select print and then select what to print.

The physical positions for the controls as well as the timed repetitions are programmable in the
Manage Controls page (see chapter 5, par. 3.2).

8. PROFILES
Analyses can be grouped in coherent lists which are called profiles. Having these
lists already programmed can make the
patients programming easier. Click on the
Profiles icon on the main icon bar. The following page will be
displayed.
The list of available profiles is displayed in the left column,
while the tests belonging to each profile are listed in the right
column.

Click on the button New Entry to enter a new profile. The

following window will appear.

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Figure 3-27

In the Name filed, write the name of the profile, then select a number to be assigned to this profile
(for instance for bar-coded programming). All possible tests, available or not on the tray, can be
added to a profile.

INSERT/MODIFY PROFILES: this function creates/modifies analyses groups, useful when

checking-in patients. It can be accessed from Tests menu or from the specific icon that allows direct
access.
It is possible to delete, update and print an already existing profile.

Creating a profile: click over New button: the Profile Name textbox will appear. Enter the name for
the profile and click on Analyses: this will open a window where it will be possible to select the
analyses for the profile. Click "Save" to store the selected analyses. It is possible to enter in the
Code for Bar-Code field a numerical code. The analyzer, when reading the bar-code labels of
Patients, will recognize it. This code is used for completely computerized acquisition of the analyses
assigned to the patient. The bar-code settings are explained in chapter 9, par. 1.4.
To update an existing profile, select it from the list and click on Modify, and then proceed as
outlined previously. To delete an existing profile, select its name and press Erase, confirmation is
requested prior to erasing.

Attention: during the patient acquisition, only the analyses present on the tray are displayed for
each profile.

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9. APPENDIX
In the following pages are presented some examples on how to program the times of an end point,
a fixed time and a kinetic test, starting from the BT3500 parameters.

End Point:

Insert R1+S Reading 10"

BT3500 Inc. R1+S= 360"

Insert R1 Insert S

Inc. R1= 4 cycles=120" Incubation + Reading=12 cycles=360"

BT3600
Reading = Point[Final]-Blank

Cy. 5 Cy. Final (17)

In a mono-reagent test, the blank is read automatically in the same cuvette where the reaction will
take place, therefore every single sample will have its own blank value.

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This type of test can be programmed in the analyzer as R2 starter

or Sample starter. When programmed as sample starter, the
reagent blank can be performed in the same cuvette where the
reaction will take place. When programmed as R2 starter, the
reagent blank will have to be performed in a second cuvette (see
par. 5.2.4).

Insert R1+S Insert R2

BT3500 Inc. R1+S= 120" Inc. R1+S+R2=60" Reading 120"

BT3600
R2 starter
Insert R1 Insert S Insert R2

Inc. R1+S= 4 cycles=120" Inc. R+S= 2 cycle=60" Reading=4 cycles=120"

Reading = Point[Final]-Point[Final-8]

Cy. 5 Cy. 9 Cy. 11 Cy. Final (15)

The reaction formula can also be written as: Reaction: Point[Final]-Point[LastInsert+4]

The reagent blank must be set on a second cuvette. It is possible to program R1 and R2 times at
cycles 1 and 2 respectively and set Point[Sample-2] as formula for reading the blank itself.

BT3600
Sample starter
Insert R2

Insert R1 Insert S

Inc. R1= 2 cycles=30"

Inc. R1+R2= 3 cycle=90" Incubation + Reading=6 cycles=180"
Total Inc. R1+R2= 4 cycles=120" Incubation Reading = Point[Final]- Point[LastInsert+4]

Cy. 2 Cy. 5 Cy. 7 Cy. Final (11)

The reaction formula can also be written as: Reaction: Point[Final]-Point[Final-8]

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This type of test can be programmed in the analyzer as R2 starter

or Sample starter. When programmed as sample starter, the
reagent blank can be performed in the same cuvette where the
reaction will take place. When programmed as R2 starter, the
reagent blank will have to be performed in a second cuvette (see
par. 5.2.4).

Insert R1+S Insert R2

BT3500 Inc. R1+S= 60" Inc. R1+S+R2=60" Reading 120"

BT3600
R2 starter

Insert R1 Insert S Insert R2

Inc. R1+S=2 cy.=60" Inc. R+S= 2 cy.=60" Reading=4 cycles=120"

Reading = RegrxMinute[LastInsert+4,Final]

Cy. 5 Cy. 7 Cy. 9 Cy. Final (13)

The reaction formula can also be written as: Reaction: RegrxMinute[Final-8,Final]

The reagent blank must be set on a second cuvette. It is possible to program R1 and R2 times at
cycles 1 and 2 respectively and set Point[Sample-2] as formula for reading the blank itself.

BT3600
Sample starter
Insert R2

Insert R1 Insert S

Inc. R1= 2 cycles=30"

Inc. R1+R2= 3 cycle=90" Incubation + Reading=6 cycles=180"
Total Inc. R1+R2= 4 cycles=120" Incubation Reading = RegrxMinute[Final-8, Final]

Cy. 2 Cy. 5 Cy. 7 Cy. Final (11)

The reaction formula can also be written as: Reaction: RegrxMinute[LastInsert+4,Final]

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CHAPTER 4
PERFORMANCES & TECHNICAL SPECIFICATIONS
1. PERFORMANCE AND LIMITS
GENERAL INFO
Operating Mode: Sequential access
Methods: Clinical Chemistry, I.S.E., Immune-Chemistry, DOA
Test Mode: Routine, Batch, Emergencies (STAT), Profiles
Tests in memory: 500 + unlimited Relation Tests
Test Re-runs: automatic or on demand
Calibrations and Controls: With time-programmable notification or on demand
Quality Control: 3 known levels and 3 unknown levels

TIME REQUIRED TO REACH STEADY STATE

Ambient conditions: 21 °C R.T., 33% RH
Time required for the cuvettes to reach steady state (from OFF status): Approx. 30 min
Time required for refrigerated bottles to reach steady state (from OFF status): Approx. 1 hour
The time required to reach the steady state may vary, as these are dependent on many factors,
among which the ambient conditions.

OPERATING AMBIENT TEMPERATURE: 18 °C to 32 °C, 10% to 90% RH, Non condensating

MAX HEIGHT: 2000m

PERFORMANCES
Tests on line: 80 refrigerated reagents + relation test (40 large + 40 small bottles)
Measurement: direct reading of 64 cuvettes in optical glass
Samples Tray: 60 samples refrigerated positions divided in 6 sectors
Standard & Controls: 60 refrigerated positions divided in 6 sectors, on the samples tray
1 arm for Samples
Sampling arms:
1 arm for Reagents
Bar code scanner: one barcode scanner for positive identification of samples and reagents
I.S.E. Module 2P: indirect potentiometry on serum and urine (K, Na, Cl)
Up to 240 Test/h clinical chemistry, double reagent
Analytical Throughput:
I.S.E. Up to 120 Test/h

VOLUMES - WORKING SOLUTIONS Min µl Max µl

Sample volume 1.8* 200
Single reagent volume 1.0 300
Reagent diluent volume 1.0 300
Reagent blank 180 380
Volume in cuvette (reagents and sample) 180 380

SAMPLE MANAGEMENT
Sample 1.8 150
Diluent 1.0 320
Sample + diluent 120 320
NOTE: the minimum volume for sample + diluent in sample management is = (Sample quantity +
5µl), when the Sample quantity is lower than 120µl
* it is advisable to use a minimum of 2µl of sample

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SYSTEM SOL. DETERGENT SOL.

UTILITY TIME
(approx) (approx)
DEDICATED SOL. (approx)

Wash cuvettes 6’ 250ml 80ml ---

Wash and fill up 7' 600ml 80ml ---
Daily wash 10’ 350ml 70ml 29ml
Extra wash cuvettes 30' 900ml 200ml 29ml + 29ml (acid + basic)
Zeroing on water 14’ 300ml 80ml ---
FCC Function 20’ 600ml 80ml 29 ml
NOTE: stated times and liquid consumptions should be considered only as indicative as they may
vary in different conditions

2. TECHNICAL SPECIFICATIONS
Transport and storage temperature: From 5°C to 50°C
Transport and storage humidity: From 10% to 90%
Transport and storage pressure: From 0.2bar to 1bar
Overvoltage: type:II
Pollution Degree: 2
Power supply tolerance: 100-240 Vac (± 10%)
Noise level: 55 dbA

CUVETTE OPERATING TEMPERATURE OFF / 37 °C

Precision: ± 0,2°C
Accuracy: ± 0,2°C
Dry heating system

REAGENT CHAMBER TEMPERATURE

Nominal Temperature: Between 5°C and 15°C Approx. (depending upon the setting)
Temperature Monitoring Device based on Peltier Effect

DILUTORS - TECHNICAL SPECIFICATIONS

Max Volume: Long life ceramic: 1x470µl (reagents) and 1x340µl (sample)
Accuracy: ± 0.1% F.S. (Full Scale)
Resolution: ± 0.1µl %
Maintenance: Every 300,000 operating cycles (O-ring seal replacement)

PHOTOMETER
Optical System Solid state 14 channels 340-800nm + reference channel
(patented by Biotecnica Instruments S.p.A.)
Detectors 14 UV/VIS photodiodes + reference channel
Photometric accuracy: ± 1% from 0 to 2.000 O.D.
Photometric Sensitivity: ± 0.001 ABS
Absorbance range: Up to 3.0 O.D. (cuvette path conversion 10mm)
Photometric Lamp: Tungsten Halogen Lamp with Dichroic Reflector
Beam Angle: 9º
Power: 50 Watts
Input voltage: 12 VDC
Avg Rated Life: Approximately 2500 hours
NOTE: The long-term use will result in the gradual deterioration of the UV emission.

ANALYZER POWER REQUIREMENTS

Universal Input: 100-240 V~ 50/60 Hertz
Power: 750 Watt
PFC Unit (Power Factor Correction) included.
Power supply tolerance: 220Vac ±10% and 110Vac ±10%

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EXTERNAL PC MINIMUM REQUIREMENTS

Operative system: Windows 10 Professional, English
Computer: IBM compatible
Processor: Pentium Quad core
RAM: 2Gb (4Gb with Windows 10)
Video: SVGA or compatible, 32K colors
Display: Color min. resolution 1280x1024
Mouse: Serial, PS2 or USB, 2+1 buttons
Host communication: RS232, TCP/IP
USB: version 2.0
Printer: Windows compatible Inkjet or Laser
CD ROM: DVD reader

DIMENSIONS & WEIGHT

Dimensions Height 58cm (22.8"), Width 84 cm (33.0”), Depth 47cm (18.5”)
Weight 60 kg (132.3 lb)

Packed analyzer – without accessories 237Kg (522.5 lb)

Packed accessories – (complete) 113Kg (249 lb)

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The product is compliant with the essential requirements of the following EC Directives:
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical instruments;
European Community Council Directive 2006/95/CE Concerning on electrical equipment designed
for use within certain voltage limits;
European Community Council Directive 2004/108/CE Electromagnetic Compatibility Directive;
It also conforms to Italian Regulations CEI EN 61010-01 and CEI EN 61326-1 (EMC).
The conformity is attested when the equipment is installed in accordance with the conditions
outlined in the manual

Operating Limits
The instrument cannot guarantee its performances in the following conditions:
- Ambient conditions beyond the specified range.
- Use of non-conformant clinical chemistry products such as washing solution, distilled water, and
etc.
- Maintenance schedule and expiry date ignored.
- Non-conformant electrical system
- Use of non-original spare parts and consumables.
The manufacturer does not guarantee the correct instrument performances in case of
implementation of unanticipated methodologies. Consult your nearest sales/service office or factory
for the use of different methodologies.
NOTE:
1. As regards the technical specifications for the system "instrumentation + reagent" used in the
applications of kit, these are the responsibility of kit’s manufacturer and will be stated in the
applications (refer to the instructions accompanying the kits).
2. The analyzer does not require (after sales) any routine electrical or mechanical readjustments.
There are mechanical and electronic adjustments performed by the manufacturer (Biotecnica
Instruments S.p.A.) during assembly and quality controls. These adjustments may be performed
again in case required by a particular technical service and in any case are at the discretion of the
authorized technical personnel only. However, It is highly recommended to check the system
periodically to prevent any faults or malfunction of the analyzer.

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CHAPTER 5
OPERATIVE PROCEDURE
1. TURNING ON PROCEDURE
Turn on the analyzer by pressing the on/off switch (see chapter 2, paragraph 3.1. Turning on the
instrument for the first time): this will turn on the analyzer itself and does not load the program. To
properly turn on all the analyzer system, turn on the external PC and load the analyzer program.
Once the analyzer program is fully loaded, the following main screen will appear.

On the lower bar right side there will be a number blinking. This number is the cuvettes temperature
read by the analyzer. This number will blink until the correct cuvettes temperature is reached.

The analyzer displays also the room temperature, the reagents

chamber and the cuvettes temperature. To see the temperatures
in an enlarged window, double click on the temperatures bar.
The analyzer is not ready to work until it has reached the steady
state and the cuvettes temperature stops blinking.

On the lower bar left side there is the messages area. Double click
on this area to view the messages displayed by the analyzer.
At the center of the lower bar there is the software version of the main program and the authorized
protection level.
After the turning on procedure, allow the analyzer to warm-up. The instrument is ready for use after
approx 30 minutes, when the temperature in the cuvettes tray has reached the proper value and the
photometric lamp is stable. At this point it will be necessary to run a zeroing of the photometer.

RUN CONDITIONS FOR PATIENTS, CALIBRATION AND CONTROLS

Patients, calibrations and controls cannot be run together. The available running conditions are:
Patients Calibrations Controls
In run can not be run can not be run
can not be run In run can be run
can not be run can be run In run
If a standard is run in the same position of the tray in which a control is already running, the
standard execution will be interrupted and vice versa if the standard is running and an attempt is
made to launch a control.

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1.1. Automatic procedures, reminders & special errors

1.1.1. Automatic procedures

Initial primes
At the analyzer start-up, it will perform the washing station and the needles primes, together with the
mechanical reset of the whole system.
Sleep mode
If the analyzer is left idle for more than 40 minutes, it will wash and fill up the cuvettes, then a
screen-saver will appear. Press any key or click with the mouse to exit from the screen-saver mode.
The automatic wash will not take place if no sampling has been performed after the previous
(positively ended) washing.

1.1.2. Reminders
Zeroing of the photometer
The zeroing of the photometer is necessary and mandatory at least once a day and only after the
steady state has been reached (the cuvettes temperature icon on the bottom right of the main
screen stops red-blinking).
In any case, every four hours the analyzer will automatically ask for the zeroing of the photometer.
The message will remain on the screen for 5 minutes, then it will disappear but it will still be present
in the Messages bar.
The zeroing reminder does not appear if:
- The analyzer is in the Diagnostic or Mechanical calibrations pages
- The analyzer is turning off
- The analyzer is in stand-by
- The analyzer is running (calibrations, tests, ...)
- The analyzer is under fatal error
- The analyzer is under optical group error
- The analyzer is under errors such as no water, no pressure, waste full....
- The analyzer is performing a washing (wash cuvettes, wash and fill up,..., prime ISE, ISE wash,
FCC, empty fluidics
- Four hours have not elapsed from the last zeroing.
In case one of the above conditions is present, the analyzer will wait other 5 minutes before
checking if the zeroing is necessary.
When the question appears, but is not answered after 5 minutes, the message is again delayed for
4 hours.
Standard & Controls
If programmed, the analyzer can remind the operator if there are calibrations or controls to run (see
par. 3.1.5. & 3.2.3.)
Maintenance
In the Diagnostics menu, there is the Maintenance table, where the ordinary maintenance items are
listed, together with their expiry date. When one of these items needs the operator's attention, the
analyzer will display a message on the screen inviting to check the Maintenance status.

1.1.3. Special errors

There are some special errors that may cause the interruption of the dispensing or the complete
stop of the analyzer.
Errors that stop the dispensing:
NO WATER IN THE EXTERNAL CONTAINER
NO DETERGENT IN THE EXTERNAL CONTAINER
EXTERNAL WASTE CONTAINER FULL
In all these conditions, the analyzer will stop dispensing, but will go ahead with the reading of all
fully dispensed tests.

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Errors that stop the analyzer:

NO PRESSURE
RESET ERROR
CRASH ERROR:
MECHANICAL ERROR
REAGENT OR SAMPLE NEEDLE OBSTRUCTED (only during the prime)
In all the above conditions the analyzer will completely stop, to avoid further damages to the system.
For instance, if there is no pressure, the system liquids may leak causing damages to critical parts
as the boards or the photometer.
It will be absolutely necessary to find and solve the problem before starting again the analyzer.

1.2. ACCESS PASSWORDS

To comply with the European law on privacy (processing of sensitive data) enacted with Italian
Legislative Decree no. 196 of 30/6/2003 passwords have been implemented for the analyzer. This
makes it possible to keep a record of the activity of each authorized operator.

To have access to the analyzer program, a sequence of USERNAME and PASSWORD needs to be
entered.

When the analyzer is installed or first used, the Administrator or lab manager must assign each
operator with a Username and password combination, associated with his own access level to the
program.

The first window that appears is dedicated to the Administrator (a manager who takes care of
archiving as well as password management of the users who have access to the analyzer).

The Administrator needs to enter the following in the Username field: ADMIN
The Administrator needs to enter the following in the Password field: Administrator

Figure 5-1

After pressing the Log-on button, a window will open where the Administrator enters his new
personal password.

Figure 5-2
The Administrator password does not have an expiration date, while those assigned to operators
need to be renewed every three months.

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Do not forget the Username and Password sequence. If this happens, the Administrator will have to
delete the operator profile and create a new one. If the Administrator forgets his own password, it
will be necessary to delete the entire list of passwords. If necessary, submit a request to the
Technical Assistance Service.
Once access to the password entry page is obtained, the Administrator must assign each operator
with his Username and Password combination. Press on New User. A window opens for typing the
Username and password and confirming the password. Next, the Administrator needs to assign the
access level allowed for the individual operator.

Figure 5-3

Each level allows access to normal analyzer operations (acquisition and running of patient lists,
Calibrations, Q.C. program and Population, etc.) plus some specific functions that would otherwise
not be available. Access to the patient archive is allowed by putting a check in the specific box.

0 1 2 3 4
Import parameters ok ok ok ok no
Modify Parameters no no ok no no
Export Parameters ok ok ok ok no
Create Tray ok ok ok ok no
Adjust Function no ok no no no
View Patients Archive ok ok ok ok no
Delete RT page no ok no no no
Reset mechanical calibrations no no no ok no
Special Functions in General Diagnostic no no no ok no

Setup I.S.E. present/not present no no no ok no

Setup – Clot: Water pressure control ok ok ok ok no
Setup – Clot: Aspiration control no no no ok no
Setup – Clot: Clot control ok ok ok ok no
Setup – Clot: Clot control - Sensitivity no no no ok no
Setup – Communication: Transport parameters no no no ok no
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Setup – Communication: Scripts no no no ok no

View QC in store selected data no ok no no no

Test counter: delete single lot no no no no ok

Test counter: delete all no no no no ok
Modify I.S.E. slope range no no no no ok
Setup – Administrator: Lot's control no no no no ok
View user in Patients archive no no no no ok
View user in QC no no no no ok

To be able to allow a user to have an access level other than 0 it is necessary to know the system
password that allows access to the same level. This is requested after selecting a level.
The system passwords can be changed in the analyzer Setup. Access is only allowed to the third
level.
ATTENTION: if the new system passwords are forgotten, it is necessary to format the hard disk and
reinstall the program. In this case any unsaved data will be lost. Biotecnica shall not be held liable
for system passwords that are changed by the user.

NOTE: the users password MUST be at least of eight characters. It is advisable to use alpha-
numeric passwords. Avoid using 8-times repeated characters such as YYYYYYYY or 33333333.
It is advisable to test the password every time a new password is programmed.

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2. REAGENTS MANAGEMENT
This function is accessed either by pressing F10 key or by clicking on the specific icon.
In the management pages it is possible to view the reagent volumes, insert and remove reagents,
create the current analyses tray, assign the reagent lot and expiry date and duplicate the reagents.

First of all it is necessary to create the on-line tray.

Remember that the number of reagents for every
test must have been already defined, before
creating the on-line tray.

Then assign the position on the tray to every test,

together with lot number and expiry date.
Figure 5-4

ATTENTION: the analyzer gives its best performances if the working phases are never
interrupted. This may happen, for instance, to insert a new reagent bottle.

The software provides a certain number of options to avoid any interruption:

1. backup reagents
2. before every run the analyzer asks for a volumes check and then warns the operator if there
is not enough reagent for completing the work-list. Answering yes to the analyzer's question will
ensure the uninterrupted completion of the work in progress.

2.1. Make tray

To create the on line reagents tray, it is necessary to move the reagent codes from the general to
the current tray list, assigning the physical position on the tray, as well as the lot number and expiry
date. In the same pages it is possible to decide if a reagent must have its duplicate on board (for
backup purposes).
Remember that the number of reagents for each test has to be defined before moving it into the on
line tray.
For what concerns duplicates, every reagent can be duplicated only once for a total of two bottles:
one master and one duplicate. Remember that the duplicates must be placed in higher positions
respect to the master (i.e. if the master is in position 12, the duplicated can be placed in any position
from 13 to 40).

To create the on line tray, select from the Available list the code or codes to move. Keep pressed
the CTRL key while clicking on the codes, to select codes randomly. Keep pressed the SHIFT key
while clicking on the first and the last code of a series to select them all.

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Figure 5-5

Use the dedicated icons to move the codes.

Click here to move only the selected code or codes to the on line tray.

Click here to move all available codes to the on line tray.

Click here to remove only the selected code or codes from the on line tray.

Click here to remove all codes from the on line tray.

When moving the codes, the analyzer will use the following criteria:
- empty positions will be filled first and in order
- for the type of bottle, the analyzer will first place the reagents in the large/small order, then
large/large, then small/small.

REAGENT INFO
Once all the codes have been moved, it is possible to customize the tray.

Figure 5-6
Click on this icon to enter the reagent info. The following page will be displayed.

The upper section is dedicated to the reagents, while the lower is

dedicated to the possible reagent diluents.
When some reagents or diluents are not used, the corresponding
area will be completely blank.

For every code, enter the following information.

Figure 5-7

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Position: select the physical position on the tray for the corresponding reagent.
Type: set the type of bottle, among those presented by the analyzer. The reagent bottles may be of
80ml, 50ml, 20ml, 10ml. Beside these, there are also the 22ml and 6ml bottles that can be used with
the special adapter.

Lot ID#: type the reagent lot number.

Expiry: type the reagent expiry date.

ATTENTION
Every time a reagent is removed from the current tray, its lot and expiry date will be deleted.

REAGENT DUPLICATION
It is possible to duplicate a reagent in order to have a backup bottle on board, already available. A
reagent can be duplicated max one time, for a total of two bottles on board. The analyzer will
automatically switch from the first to the second as soon as the reagent is finished. Note that the
analyzer will not switch from the second to the first bottle. Before every run the analyzer will ask if
the operator would like to perform a volumes check. This will update the reagent volume in the
bottles and enable the analyzer to use a backup bottle if necessary. The samples performed with
the backup bottle will be marked with the K flag, meaning that a new calibration is necessary for the
test.
Click on the + (plus sign) to duplicate a code or on the – (minus sign) to delete the
duplicates.
The duplicated reagents will be added on the list after the master and will be
identified as BAK and colored in light green.

Figure 5-8

The duplicated reagents must be programmed in higher positions respect to the master. To set lot
number and expiry date, proceed as for the other reagents.
With the bar code active, to insert the backup reagents, proceed as follows: insert the master and
have the bar code read, then insert the backup reagent and read the bar code. If the master was
already in position, insert only the backup reagent: the analyzer will check the presence of the
master in its position.
NOTE: in calibrations the backup reagents are not used to avoid the standard points to be
performed partially with the master and partially with the backup reagent.
Once all necessary settings have been made, click on the Save button, or click on Cancel to abort
all modifications made. Click on the Print button to print the reagents map.

Figure 5-9

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2.2. Insert / Remove Reagents and volumes check

This function helps the user to correctly position the reagent bottles, as programmed in the current
tray.

Figure 5-10
The reagent tray is divided into sectors, identified by the letters A, B, C, D and E. Each sector has 8
positions.

Figure 5-11

The screen displays the representation of 8+8 bottles. The analysis codes of large bottles are
displayed on the lower positions, while the upper positions indicate the codes used for small bottles.
The diluents and I.S.E. reagents are displayed below the chemistry reagents.

The symbols 1.XXX and 2.XXX can be displayed inside the bottles. The symbols 1.XXX, 2.XXX,
3.XXX and 4.XXX indicate the position of the first, second, third and fourth bottle pertaining to a
multi-reagent code.
Click on the Check volumes button to verify the solutions in the bottles. The analyzer will then
update the graphical representation.
Click on the Print Button to print the reagents tray
information, including the lot number.

NOTE: The refrigerated reagent compartment helps maintain the stability of the reagents, but
can not replace the function of a refrigerator at 2-8 ° C, so the reagents must be removed
from the analyzer and placed in the refrigerator as soon as possible.

SECTORS
In the Sector area, the five sectors are represented on a rotating wheel. Click
on the letter corresponding to the sector and this will be presented in the
reagents page. The letter indicating the present sector is in capital letters and it
is placed at the bottom center of the wheel.

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To insert a sector, select it first as explained above, then click on the Insert Sector button. Open
the reagents cover and introduce the sector, then answer to the analyzer's question. Click on the
Check sector volumes button. The analyzer will now verify the volumes present in the sector's
bottles and will update the graphical representation. When using the bar-code, it is possible to
identify the reagent bottles by scanning the sector. Click on the Scan sector button. The bar-code
settings are explained in chapter 9, par. 1.4.
The analyzer will read the bar-code labels and assign the reagent positions automatically. In case of
errors or misreading a window will appear listing the occurred errors.

BOTTLES
To insert a single bottle, right click on it and the analyzer will display the following options.
Insert bottle: allows the operator to enter a reagent in the correct position. The
requested bottle will be presented right in front of the reagents chamber. Open
the cover and opportunely answer the analyzer's question. Then the analyzer will
verify the volume present in the bottle and will update the graphical
representation.
Present position: the analyzer will only present the required position, without
performing any control.
Check volume: the analyzer will check the volume inside the bottle.
Scan position: the analyzer will read the bar-code label and assign the correct code and analytical
parameters to the selected position. The bar-code settings are explained in chapter 9, par. 1.4.
ATTENTION: to insert the 80ml bottle, it is necessary to remove the corresponding sector,
insert the bottle and place the sector back.
Manual bar-code entry: in case it is not possible to rad the reagent’s bar-code, click this option to
enter manually the bar-code. In case of double reagents, type both
bar-codes with a space in between. To exit without saving, press the
Save button when the editable filed is empty.

INSERT REAGENTS: This functions allows entering a series of reagents one after the other. This
special function puts the analyzer in STAND-BY. The
stand-by is opened only AFTER all dispensations are
terminated (both serum and reagents – max 9 min). A
second window is opened.
The final check of the reagents, including the bar-
code reading will be performed only when closing
the secondary window. This allows the operator to
save time when entering more than one reagent
and avoid the annoying procedure of checking
every single reagent one by one.

INSERT SPECIAL REAGENTS (DILUENTS)

This options allows the insertion of the special reagents, i.e. the diluents.
Right clicking on the diluents bottles a small window appears, with two options:
Check volume: will simply check the volume inside the selected diluents bottle.
Insert bottle: will put the analyzer in STAND-BY and allow the Operator to
remove/insert the diluents bottles in order to refill them. In this case the analyzer will terminate all
the serum dispensations before entering in stand-by.

The special characteristic of the above features is that the analyzer is put in STAND-BY. So, the
reagents insertion can be done during the working phases. The limitation is that the reagents
insertion is allowed only after all dispensations are performed, so it can be useful in case of
continuous loading of samples, but not if the initial volumes check has not been performed and the
reagent is not enough to complete the run. The special reagents insertion is less limitative and can
be performed after all samples have been dispensed. Therefore, when the Operator has finished,
the stand-by is terminated and the analyzer restarts its working phases.

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DILUENTS AND I.S.E. SOLUTIONS

In the lower part of the Reagents Management window there is the graphical representation of the
diluents and I.S.E. solutions bottles. Right clicking on one of the diluent bottles or on the I.S.E.
sample diluent, it is possible to let the analyzer verify the volume in the single bottle.

VOLUMES
For every reagent and diluent bottle is graphically indicated the remaining volume in a green to red
fading scale.
To see the remaining volume and tests available in the chemistry bottles, left-click on the
corresponding position.
The upper bottle corresponds to a 10ml or a 20ml bottle, while the
lower bottle corresponds to a 50ml or 80ml bottle.
When clicking on the desired bottle, a small window will appear
showing the test name, the remaining reagent volume (Quantity)
and the number of tests which can be performed with the remaining
volume in that single bottle (Samples), according to the set
parameters. The Max Samples column indicates the max number
of tests that is possible to perform with the reagents combination.
Figure 5-12

2.2.1. Inserting reagents "in run"

It is possible, but not advisable to insert reagents when the analyzer is already in run. This
procedure may stop the analyzer work for a period of time minimum of 32 seconds and maximum of
9 minutes, depending on the phase the analyzer was when the reagent insertion was required.
The analyzer will stop dispensing R1, will continue all necessary R2, R3, R4 dispensations, then will
let the new reagent to be inserted. If the reagent position is not "in run", the analyzer will read the
bar-code and then will go ahead with the normal working phases.

2.3. Reagents swap procedure

When backup reagents are programmed, the analyzer will swap to the backup bottle when the
volume in the reagent bottle has reached the volume limit with the following criteria:
1. the volume limit will be different for every test as it is dependent upon the programmed reagent
volume and the bottle size
2. the volume limit for the swapping procedure is given when there are 5 samples left
The analyzer works with couples of cuvettes and the arms receive the sampling command in
advance for four cuvettes. The analyzer will give the swap command when there are 5 samplings
left for the reagent. In this way it is possible to ensure the sampling in the four cuvettes that have
received the sampling command in advance.
Sampling swap procedure:

Figure 5-13

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The analyzer asks for a volumes check before starting every run in order to update the volumes in
the bottles. If a reagent bottle has already reached the percentage limit, the analyzer will start the
sampling directly with the backup bottle. A reagent can be duplicated a max of one time, for a total
of two bottles on board. The analyzer will automatically switch from the first to the second bottle as
soon as the reagent is finished. Note that the analyzer will not switch from the second to the first
bottle. If the percentage limit is reached during a run, the analyzer will swap to the backup bottle
automatically. In case, for any reason, a reagent gives the No reagent alarm, the analyzer will
automatically swap to the backup bottle, but a max of four samples may be lost. In this case the
results will be flagged with the R flag and it will be possible to repeat the sampling with the
Repetition for analyses procedure (see par. 4.6.1).
When using the backup reagents, pay attention to the following:
- the master bottle must have a position lower than the backup bottles
- the analyzer must know that the reagents are present, i.e. the analyzer must have detected the
reagent volumes at the beginning of the run and these must be actual and updated
- before a run it is always advisable to let the analyzer verify the volume of the reagents.
- the analyzer will use the master reagent, then will swap to the following backup reagent.
- ATTENTION: the swap will not take place in the following cases:
- the backup reagent is empty or it has already reached the minimum percentage
- in a double (or more) reagent test with R2 dispensed after the sample, the analyzer will not swap if
one reagent (of the master couple) has already been dispensed. This because a test can not be
performed with reagents belonging only partially to the master couple and partially to the backup.
Example 1: test with R2 starter - 20 samples. The analyzer will dispense the R1 for all samples,
then dispenses the sample and then it can dispense only 10 R2 with the master. In this case, the
first 10 samples are all performed with the master couple of reagents so all 10 will be correctly
performed. The remaining tests will not be sampled with R2 backup after having dispensed the R1
master, because they belong to different matching couples, so they will be flagged with "R".
Example 2: test with R2 starter - 20 samples. The analyzer will dispense the R1 for 15 samples (at
this point R1 master is finished and the analyzer will swap to R1 backup), then dispenses the
sample and then it dispenses 15 R2 with the master reagent. In this case, the first 15 samples are
all performed with the master couple of reagents so all 15 will be correct. The remaining tests will be
sampled with the R1 backup + R2 backup. Same dynamic will take place for serum starters.

CAUTION:
DYNAMIC IN SAMPLES AND VOLUMES CALCULATION
At the beginning of a run the number of samples that can be performed with the initial volume of a
reagent is calculated by the analyzer and is stored as an internal information: it is not displayed in
the reagents information window. Then, during the run, the analyzer uses and decreases this
internal number, without using the read volume in the bottle anymore for the same calculation.
When the limit dead volume (2.5 mm from the bottom) is reached, the volumes map will show the
following flag "<" and the residual number of samples will be 0. This situation will correspond to
approx 4ml (or less) for the 50ml bottle and 1ml (or less) for the 20 ml bottle.
The number of available samples in this countdown is created at the beginning of the run
with the reagents which are present in that moment on the tray.
It is therefore very important to let the analyzer verify the volumes and, when possible, to
place new reagent bottles when the volume is not enough.
When a insert reagent/sector is performed during a run, the backup reagents list is recreated
in order to keep it updated.
When the analyzer is using the backup reagent and the master reagent is inserted, the
analyzer will finish the run using the backup reagent, but will use the master for the next run.
It does not matter if the backup reagent was empty or not.
In these conditions, if a calibration with the backup reagent is necessary, it has to be
performed while the backup reagent is still in use, then the results have to be adjusted and
stored into the archive before running the calibration with the new master reagent. Otherwise
a new ‘general’ adjust may recalculate all results (performed with the backup reagent and
with the new master).

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3. CALIBRATIONS & CONTROLS

As already seen, the calibrators and controls parameters are programmed in the analytical
parameters pages.

The positions on the standard & controls tray’s positions are programmed by clicking on the
dedicated icons on the main icons bar.

Click on these icons to access the calibrations/controls pages.

Figure 5-14

3.1. Calibrations
In the Manage standard page it is possible to select all the codes stored in memory, as well as only
those that are not in the tray or only those that are on line. Click on the corresponding button on the
top icon bar.

The selected code type list will be displayed in the page. In this page there are two tags: one is for
the Immediate standards, the other is for the Timed standards. The only difference between the
two pages is in the timed standards programming, which appears in the last column on the right and
will be explained afterward.
If the Lot ID# is not assigned, the analyzer will not run the calibration.
The buttons on the right side of the window are in common for both tags.
Select/deselect: allows simultaneous selection/deselection of all listed codes.
Modify lot name: allows the modification of the lot name for multiple codes simultaneously. Use the
CONTROL or SHIFT keys and the mouse to select random or sequential codes respectively, then
press the button, write the lot number and select the expiry date. These will be assigned to all the
highlighted tests.
Print: opens the printing interface (see
chapt. 3, par. 2.1). From this page it is
possible to print the calibrations, to save
the file in pdf format or to export it in other
formats.
The printout will list the codes, the positions
on the tray and the Lot ID. The codes
selected to run the calibration will be marked with an X.

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The Positions Map will open a map where is displayed a

summary of the analyses and the used positions. In the
example, GGT has three standards, in position C1, C2 and C3;
GOT has threes standards, all in position A1.

Run: click on this button to run the calibrations. See also par. 3.1.4. Running calibrations.

Import and Export: this function allows to export and import the Calibration
parameters.

It is necessary to select the codes of the analyses for which the backup is desired, then to add a
Description and to select the location for the backup file. The Description is mandatory and it is
necessary to identify the backup file when it will be imported again.

Select the folder where backup file was saved and select the file you want to import, using its
description in the right side of the window. Double click on the file description. The analyzer will ask
for confirmation before overwriting the data.

The Import/Export function saves the calibration parameters. It will not save the analytical
parameters or the positions on the tray of calibrators & standards. The original positions on the tray
as well as the timing for timed calibrations will remain unchanged.

Exit: click on this button to close the Manage standard window.

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3.1.1. Programming Standards (Immediate)

In this page it is possible to select which tests will have to be calibrated and in which position on the
tray. The tray allows a total of 60 positions freely shared between standards and controls.
The first column in the page, Select, is dedicated to the check-boxes for selecting the calibrations to
be performed. In the second column there is the list of the codes.

The following columns are identified as #1, #2, #3, #4, #5 and #6. These numbers correspond to the
same numbers in the standard analytical parameters page.

Immediate standard

Std. analytical parameters

It is necessary to respect the above described relationship between numbers, in order to correctly
assign the positions on the tray.

In the above picture there are the analyses programmed. The ALBC test has a calibration curve on
positions from D1 to D6 of the inner ring tray’s positions. The test
GOT is a linear test programmed to repeat three times the calibrator
in position A1. Tests GGT and CRE are programmed to perform the
calibration on three different points. It is possible to notice that the
positions assigned concomitantly to more than one test are
highlighted in bold red. The same character format is used also if the
same test is repeated three times in the same position: again the
position will be in bold red. To change the position assigned to a
standard, click on the number field and select the desired position,
starting from the sector, then select the number.
Figure 5-15
NOTE: when the analyzer is already running calibrations (or
controls) and the operator runs controls (or calibrations) which are in
the same physical positions on the tray, the analyzer will not run all
of those controls which are in the same positions of the already in run calibrations.

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3.1.2. Linear calibrations with or without automatic dilution

The way standards are programmed in the analytical parameters and in the Manage standard page
will automatically give the analyzer the necessary information to perform the calibrations in different
ways.

LINEAR CALIBRATION WITH THREE SAMPLINGS FROM THE SAME POSITION

In the standard analytical parameters page, the test must

have no dilution and the same concentration repeated
three times.

In the calibrations page, the three standard must be in the same position on the tray’s standard
positions.

With this programming the analyzer will take the calibrator three times from the same cup.
The positions on the tray are in bold red, thus meaning that the same position is used for all the
three standards.

LINEAR CALIBRATION WITH THREE SAMPLINGS FROM DIFFERENT POSITIONS AND NO

AUTOMATIC DILUTION

In the standard analytical parameters page, the test must

have no dilution and three different concentrations.

In the calibrations page, the three standard must be in different positions on the tray’s standard
positions.

With this combination, the analyzer will take the standards from the three different cups, without
performing any automatic dilution and will calculate the factor as a mean of the three factors
calculated each on every single point.

LINEAR CALIBRATION WITH THREE SAMPLINGS FROM THE SAME POSITION AND WITH
AUTOMATIC DILUTION
In the standard analytical parameters page, all three
standards must have their dilution, manually entered or
automatically calculated by means of the serial dilution.
The three standards must also have three different
concentrations, according to the respective dilution.
In the calibrations page, the three standard must be in
the same position on the tray.

With this combination, the analyzer will take the

standard from the cup in position 1 of the tray for three
times. For the standard #1 and #2, the analyzer will also
perform an automatic dilution.

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It is also possible to program the analyzer to take the standards from three different cups,
performing the programmed dilution for each, but usually this is only a waste of calibrator.

The automatic dilution is performed as follows. The analyzer will take the standard from the cup and
will dilute it into a first cuvette, then it will take the diluted standard from the first cuvette and use it
for the reaction in a second cuvette. The separated preparation of every standard allows the
analyzer to dilute the standards (or the samples) with the maximum flexibility.

3.1.3. Non linear calibrations with or without automatic dilution

The same descriptions seen above for the linear calibrations apply to the non linear calibrations.
CALIBRATION WITHOUT DILUTION

In the calibrations page, every of the six standards must be in a different position. In the standard
parameters page, the dilution for each point must be set to 1:1 and each point must have its own
different concentration.
The analyzer will simply take the standard from each cup to perform the reaction.

CALIBRATION WITH DILUTION

In the standard analytical parameters page, all six standards must have their dilution, manually
entered or automatically calculated by means of the serial dilution.
The six standards must also have different concentrations, according to the respective dilution.

In the Manage standard page, the six standards must be programmed in the same position.
The analyzer will take the standard from the cup six times, performing every time the necessary
dilution in a separated cuvette.
It is also possible to mix the two methods, if necessary, by opportunely programming the standard
and positions as follows.

For standard #4, #5 and #6 the Dilution 1: field must be set to 1. Then the standard positions can
be programmed as:

In this case the analyzer is expecting a whole standard in position #1. It will take the standard three
times from the same position and will dilute it on the basis of the Standard programming. Standard
#4, #5 and #6, will be placed in positions #4, #5 and #6. In this case, the analyzer will not perform
any dilution on standards in position #4, #5 and #6.

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Always remember that the analyzer will perform, for every standard, the dilution set in the field
Dilution 1:, therefore the positions on the tray must be assigned to the standards accordingly.
ATTENTION: the same above explained is applied also to linear calibrations.

3.1.4. Running calibrations

To run the calibrations it is necessary to select the codes by checking the desired check-boxes.
Remember that in the Manage standard window it is possible to view the codes that are on-line,
the codes that are not on-line or all codes. Select one of these options and then proceed.

Verify that the selected codes have their Lot ID#. To assign a Lot name or number select single or
multiple codes and clock on Modify Lot Name. To assign simultaneously the same ot name, click on
scattered codes keeping the CTRL key pressed or click on the first and last code in a sequence
keeping the SHIFT key pressed. Then click on the Modify lot name button.
Enter the lot name, the expiry date (pay attention: the date loaded by default
is today’s date) and press Save.

To run the calibrations, it is possible to select or deselect all codes clicking on

the dedicated buttons on the top right of the window..
Once all desired codes have been selected, press on the Run button. The
analyzer will display the following question.

In case of positive answer, the analyzer will start the sampling. In case of negative answer, the
analyzer will display the standard positions map.

Clicking on every position number, the analyzer will rotate the tray to present the correct position
where the operator can insert the standard cup. The already inserted standards will turn background
color from white to green.

Once finished, click on the button Accept to run the calibrations. Press Exit to abort the procedure.

The analyzer calculates the number of available tests with the volume in each reagent bottle by
checking the volume at the beginning of the run, so it is very important to answer YES when the
analyzer asks “Do you want to perform a volumes check?” (see also 2.3. Reagents swap procedure
- DYNAMIC IN SAMPLES AND VOLUMES CALCULATION)

When there are calibrations in run, these will

have a different background color in the
Manage standard page.

Attention: when a code is in run in the

Immediate standards, it will be of the same
color also in the Timed standards page.

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3.1.5. Programming Standards (Timed)

The timed calibrations page is similar to the immediate calibrations page, with the only difference of
the last column, where it is possible to program the calibration repetition parameters.
For all other info, please refer to the previous pages.

Figure 5-16

The timed calibrations programming window will be opened by double clicking on the Program
column field corresponding to every code. The programming will only activate a warning reminder
message: the calibrations will not run automatically. It will be on the user responsibility to verify the
presence of the cups and reagents and then to run the determination.

Every day at: the reminder message will be presented every day at the specified hour. For
example, setting "08" "30" the message will be
displayed every day at 08:30 in the morning.

Days + hours interval: the reminder message will be displayed at the time intervals as
programmed into the Days + Hours boxes. For
example, setting "02 + 8" the reminder will be
presented every two days and eight hours.
Setting "00 + 8" the message will be displayed
every eight hours. Setting "1 + 0" the reminder
will be presented 24 hours after the last determination. In the Timed Standard page the
programmed timers will be displayed synthetically in the Program column as follows.

Every day at 8:30 in the morning

Every eight hours
Every 3 days and 5 hours
Every two days
Every day (24 hours after the last time the calibration was run)

ATTENTION! In the Timed page, the positions are not the same as in the Immediate page. All
positions for timed calibrations must be newly programmed in the dedicated page.

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3.2. Controls
All the Controls pages are very similar to the same pages dedicated to the standards.

Figure 5-17
In the Manage controls page it is possible to select all the codes stored in memory, only those that
are not in the tray or only those that are on line. Click on the corresponding button on the top icon
bar.

The selected code type list will be displayed in the page. In this page there are two tags: one is for
the Immediate controls, the other is for the Timed controls. The only difference between the two
pages is in the timed controls programming, which appears in the last column on the right and will
be explained afterward.
If the Lot ID# is not assigned, the analyzer will not run the control.

The buttons on the right side of the window are in common for both tags.
Select/deselect: allows simultaneous selection/deselection of all listed codes.
Modify lot name: allows the modification of the lot name for multiple codes simultaneously.
Print: opens the printing interface (see chapt. 3, par. 2.1). From
this page it is possible to print the controls, to save the file in pdf
format or to export it in other formats.
The printout will list the codes, the positions on the tray and the
Lot ID. The codes selected to run the control will be marked with
an X.

Click on the Positions Map, to see the positions occupied by the controls in the tray

Run: click on this button to run the controls. See also par. 3.2.2. Running controls.
Exit: click on this button to close the Manage control window.

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3.2.1. Programming Controls (Immediate)

In this page it is possible to select which tests will have to be run and in which position on the tray’s
dedicated positions. The tray allows a total of 60 positions freely shared between standards and
controls. The first column in the page, Select, is dedicated to the check-boxes for selecting the
controls to be performed. In the second column there is the list of the codes.
The following columns are identified as Known #1, Known #2, Known #3, Unknown #1, Unknown
#2 and Unknown #3. These definitions correspond to the same in the control analytical parameters
page.
In the controls analytical parameters both the
known and unknown sections offer three levels
(#1, #2 and #3).

Because of the limited space, the definitions

have been shortened and the correlation
between the analytical parameters and the
Manage controls page definition is explained
here below.

Analytical parameters Manage controls

Known Level 1 Known 1
Known Level 2 Known 2
Known Level 3 Known 3
Unknown Level 1 Unknown 1
Unknown Level 2 Unknown 2
Unknown Level 3 Unknown 3

To allow the analyzer to correctly elaborate the results, it is necessary to respect the above
described relationship between numbers, in order to correctly assign the positions on the tray.

Figure 5-18
In this picture it is possible to see some programming conditions.
Test GOT: as it is possible to see from the Info column, both known and unknown controls are
programmed and the test is selected, but the three unknown controls are correctly programmed in
three different positions, while the three known controls are programmed all in the same position.
Controls of different levels can not be assigned to the same position and the same is for controls of
different type. The analyzer will display an error message.

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Test CURV: the positions are correctly assigned, even if not all six levels will be performed.
Test CRE: all controls (type and levels) are programmed in the same position: this will generate an
error.
Test GLU: the first two levels of the known controls and all unknown levels are correctly
programmed. Level 3 of the known control is programmed in position 1 and this will cause an error.
Test I.S.E.: all type of controls are correctly programmed and positions are all correctly assigned.
Test PTO: this test has no controls programmed, therefore the analyzer will highlight this situation
writing ** ERROR ** on red background. This control can not be run.
For all controls, double-clicking on the corresponding line in the Info column, will automatically open
the analytical control parameters page, which lets you enter the missing data or update the existing
ones. All positions used for more than one control are in bold red.
To change the position assigned to a control, click on the
number and use the arrows or type a different number.
The field in editing will be the only white one in a line with
blue background.

For all controls the different levels are selected by means of the following checks.

Once the Known Level 1 is selected, the analyzer will

perform it for all selected codes.

If usually the known and unknown third level are not used, it is simply possible to program the
analyzer as in this picture.
The analyzer will ignore the positions programmed for these two levels and will not perform them.

In case the operator does not want this type of simultaneous running, it is possible select, for each
test, only some levels per type (see in the next paragraph the list optimization)

NOTE: the standard & controls tray positions are shared between standard and controls. When the
analyzer is already running controls (or standards) and the operator runs standards (or controls)
which are in the same physical positions on the tray, the analyzer will not run all of those standards
which are in the same positions of the already in run controls.

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3.2.2. Running controls

To run the controls it is necessary to select the codes by checking the desired check-boxes.
Remember that in the Manage control window it is possible to view the codes that are on-line, the
codes that are not on-line or all codes. Select one of these options and then proceed.

Verify that the selected codes have their Lot ID# programmed for all selected levels. To assign a Lot
name or number, double click on the Info field of the desired code.

The controls analytical parameters page

will be displayed. Type the necessary info
and then save.

Figure 5-19

It is also possible to select multiple codes to assign simultaneously the lot

name. Click on scattered codes keeping the CTRL key pressed or click on
the first and last code in a sequence keeping the SHIFT key pressed. Then
click on the Modify lot name button. Enter the lot name and press Save.

To run the controls, it is possible to select or deselect all codes clicking on

the dedicated buttons on the top right of the window..

Once all desired codes have been selected, press on the Run button. The
analyzer will display the following question.

Controls list optimization

Answering yes, the analyzer will give the possibility to further decide what to run and what not.
For instance, for the following Controls programming map:

Figure 5-20

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The analyzer will display the following window:

Figure 5-21
Here it is possible to remove or add the check to the desired checkboxes.

Figure 5-22

There is also the possibility to Select/Deselect all using the dedicated buttons on the right side of
the window.

Once done, click on Run to proceed or on Abort to go back without saving.

Clicking on Run, the analyzer will first display the following question,

Then it will proceed with this question.

The analyzer calculates the number of available tests with the volume in each reagent bottle by
checking the volume at the beginning of the run, so it is very important to answer YES when the
analyzer asks “Do you want to perform a volumes check?” (see also 2.3. Reagents swap procedure
- DYNAMIC IN SAMPLES AND VOLUMES CALCULATION)

In case of positive answer, the analyzer will start the sampling. In case of negative answer, the
analyzer will display the control positions map.

Figure 5-23

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Clicking on every position number, the analyzer will rotate the control tray to present the correct
position where the operator can insert the control cup. The already inserted controls will turn
background color from white to green.

Figure 5-24
Once finished, click on the button Accept to run the controls. Press Exit to abort the procedure.
When there are controls in run, these will have a different background color in the Manage control
page.

Attention: when a code is in run in the Immediate controls, it will be of the same color also in the
Timed controls page.

If even for one programmed test, all the lots (known or unknown)
of the selected controls were missing, the analysis could not be
executed and the run would be aborted. If, on the other hand,
one of the lots of the selected controls was
missing, all the tests would be performed, but
without the corresponding controls for the
missing lots.

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3.2.3. Programming Controls (Timed)

The timed controls page is similar to the
immediate controls page, with the only
difference of the last column, where it is
possible to program the control repetition
parameters.
For all other info, please refer to the previous
pages.

The timed controls programming window will be

opened by double clicking on the Program
column field corresponding to every code. The
programming will only activate a warning reminder message: the controls will not run automatically.
It will be on the user responsibility to verify the presence of the cups and reagents and then to run
the determination.
Every day at: the reminder message will be presented every day at the specified hour. For
example, setting "08" "30" the message will be
displayed every day at 08:30 in the morning.

Days + hours interval: the reminder message will be displayed at the time intervals as
programmed into the Days + Hours boxes.
For example, setting "01 + 6" the reminder will
be presented every one day and six hours.
Setting "00 + 8" the message will be displayed
every eight hours. Setting "1 + 0" the reminder
will be presented 24 hours after the last determination.

Every "n" samples: the controls determination will be performed every "n" samples. For example,
setting 20, the analyzer will remind to run the
controls every 20 samples.

In the Timed Controls page the programmed timers will be displayed synthetically in the Program
column as follows.

Every day at 8:30 in the morning

Every eight hours
Every 3 days and 5 hours
Every day (24 hours after the last time the control was run)
Every 20 samples

ATTENTION! In the Timed page, the positions are not the same as in the Immediate page. All
positions for timed controls must be newly programmed in the dedicated page.

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4. SAMPLES & SAMPLES TRAY

The samples, i.e. the patients can be programmed easily in batch mode or in a better detailed way
using the routine mode (Patients menu).
It is possible to program STAT samples at any moment in the Patients work-list.

SAMPLES TRAY
The analyzer’s sample tray is made of six sectors, each identified by a letter (A, B, C, D, E and F)
and carrying each 10 positions in the external ring and other 10 positions in the internal ring. The six
sectors provide great flexibility in sample loading, as they are independent from each other. The
sectors can be inserted singularly, each in its own position, since the required software procedures
are followed.
Each sector has its own letter printed and has 10 positions, numbered from 01 to 10 in the space
between the two rings. It is possible to work (run tests) even if not all sectors are inside the
analyzer, but it is not possible to exchange the sectors’ position. This means that sector A must be
in its position, as well as all other sectors.

Figure 5-25
The analyzer can distinguish the different sectors, therefore, if the samples are programmed on
sector A, but then the sector B is run, the analyzer will give an error message.

The external ring of the samples sector allows the use of primary tubes or cups and is dedicated to
samples (whole). The inner ring houses the controls, the standards and the sample pre-dilution cups
(special preparation) programmed in routine (Sample data). When a special preparation is required,
it will be performed in the cup of the inner ring corresponding to the same position of the external
ring, where the whole sample is located. There will therefore always be a numerical
correspondence: external ring position A1 => whole sample, inner ring position A1 => cup for the
dilution of the sample in A1.

In the Routine worklist, the Insert sectors command is present under the
Options menu. This function allows the operator to introduce the desired sector
(or sectors) in the housing and is followed by a routine for recognizing the
sectors' presence. The same routine takes place before a run and before a bar-
code reading.

In the Routine worklist, when clicking on the New Entry button or after saving a programmed
sample, the analyzer will search for the first next position free. If a sector is missing, the analyzer
will automatically switch to the next present sector.

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Click on the Patients or Batch icon to enter in the dedicated pages.

4.1. Batch entry

Figure 5-26
As in other parts of the program it is possible to display all test codes, only codes in the current tray
or only codes not in the current tray. Select the desired list by clicking on the button.
The list of the codes is displayed. Click on a code to program the batch. The samples tray has 60
positions available divided into four sectors: A-B-C-D-E and F, of 10 positions each. To make the
programming easier, use the Select and Deselect buttons after having entered a numerical Range
to operate with.

Figure 5-27

After having selected the positions on the tray, it is necessary to confirm which tests
will have to be performed. This is done by clicking on the checkbox near each
analysis code. When the check is present, the test will be performed.

The type of sample used in the batch is by default the serum. It is possible
to select a whole batch to be on urine by clicking on the checkbox Batch
on urine.
In this case all samples will be dealt with as urines.

When the batch has been selected (positions, codes and sample type) click on the Run button to
perform the tests selected.

The analyzer will display the following question.

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The patients already programmed in the current work-list will not be lost, but will be moved to the
extra list. Only Routines with ID code and Autobatch samples will be moved to the Extra list: a Batch
already present in the worklist will not be moved. The extra list is an additional list, where the
positions on the tray are not assigned. In a second moment it will be possible to move again the
programmed patients to the current list (see par. 4.4). Answering no, the procedure will be aborted.
Answer yes if the current list is empty or if there are no problems in moving the patients. The
analyzer will display the following question.

Answer yes if the cups are already positioned in the tray, or answer no to let the analyzer guide you
in the cups insertion. In this case the analyzer will display the batch list as below.

Click on a single position and the analyzer will rotate the tray in order to insert easily the cup in the
correct position. The inserted cups' positions will turn from red to blue background.

Once all selections are done, click on the Accept button to let the analyzer start the run.
To start the run immediately, skipping on the above mentioned procedure, answer Yes to the
question "Do you have already inserted the samples?.
The analyzer will display the following question.

The analyzer calculates the number of available tests with the volume in each reagent bottle by
checking the volume at the beginning of the run, so it is very important to answer YES when the
analyzer asks “Do you want to perform a volumes check?” (see also 2.3. Reagents swap procedure
- DYNAMIC IN SAMPLES AND VOLUMES CALCULATION)
With the check the analyzer will update all reagents volumes and will be therefore able to swap to
the backup reagent when necessary.
The running samples are always loaded into Current list. To view these, click on the Patients icon.
There it will be possible to view all the work-lists: Current list, Extra list and Samples performed.
The samples programmed in batch will be identified as Batch XX.

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4.2. Patients entry

Clicking on the Patients icon all the work-list will be displayed.

Each sector is identified by its letter as A01 to A10, B01 to B10 and so on. The sector's positions will
be alternated in colors, to make it easier to distinguish one sector from the following.

Figure 5-28

There are three work-lists:

Samples performed: here are listed all the performed samples, which are present also in the Real
time pages. Once data are stored, the samples listed here will be archived and will not be available
any more.
Current list: here it is possible to program the routine and are shown all programmed and running
samples.
Extra list: in this list it is possible to store samples which has been already programmed, but do not
have a position on the samples tray already assigned.

These buttons are available for easy access to the functions.

New entry: to program a new sample.

STAT: to program a new STAT sample.
Run all samples: to run all programmed samples.
Close: to close the patients programming and go back to the main page.

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4.2.1. Programming patients

The positions are color-coded.
Green: free and available for programming
Blue: already programmed
Red: programmed and running
Beside every position number there is a small cup. These cups indicate the type of sample and are
color-coded.
Gray: free and available for programming
Yellow: normal sample
Red: STAT
Blue: control

The small test tubes next to the color code indicate if, during the acceptance, a sample pre-
treatment (special preparation) with one of the diluent solutions was selected for that sample. Pre-
treatment will take place in the inner ring capsules, in the same positions as the sample, when
available and free.
Sample without special preparation

Sample with special preparation

To program new patients it is possible to click on the New Entry button or to click on the number of
any free position in the list. The Sample's Data window will be displayed.

On the right and bottom sides of this window there are respectively the Profiles and Analyses
fields. Click on these fields to open/close the corresponding lists. When the Sample's Data window
is opened, by default it will have the analyses list open and the profiles list closed as in the picture
below.
Samples can be saved only if a code is assigned. If analyses have not been assigned, the analyzer
will warn the operator with a message, but the sample can be saved and completed later.

Figure 5-29

In this page the number of the position in programming is reported in the header.

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Code: type in this field the ID code for the patient. This ID# can be used for fast search in the
archives. It is the only mandatory information for saving the
sample. The user can also enter the code of a patient saved in the
work list, even if in execution. In this case, a message asks the
user to confirm patient’s data cloning. All the data relevant to the patient are instantly displayed and
are linked to the current position. The cloning of a patient’s code allows the user to link different
samples such as serum and urines when running relation tests (see Note on Clones at the end of
the paragraph).
The "plus" symbol allows the duplication of the patient. A duplicate can be changed in every part of
its programming. Clicking on this symbol the following window will appear.
Enter the Number of duplicates as desired, considering that the
final number will be "master+duplicates". The ID code can be auto-
assigned (Autobatch XX) or can be assigned by the operator.
Enter in this case the Start code ID#. It is possible to use numbers
and letters. The codes assigned by the analyzer will follow these
criteria:
Numeric code: it is increased by 1 unit
Alphanumeric code: one character is added, starting from 1.
The "0" at the beginning of the numeric codes will be deleted.

Examples:
Start code ID# is 001 – four duplicates

Start code ID# is 20 – four duplicates

Start code ID# is 0A10 – three duplicates

Start code ID# is 0 – five duplicates (codes from 1 to 5 have been skipped as already present in the
work-list)

When entering the Start code ID# and the Number of duplicates in an already existing work-list,
remember that the already present codes will be skipped. For instance if codes 10-11-12 and 13 are
already present and the starting code for duplication is 9, the analyzer will create code 9, followed
by 14-15-16, etc.

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PATIENT DATA
Surname and Name: enter the patient's data. Then enter in the Note field the necessary
information to complete the patient's clinical situation. These information will also be saved into the
Patients Archive.
Then it is necessary to select the following.

Element: select the type of processing for the sample. It may be a normal Routine, a STAT or a
Control.
In case the operator wants to run a control among the samples, it is possible to set
here the control parameters. Select the Type if known or unknown and the Level if
Level 1, Level 2, or Level 3.

Group: select one of the available groups. Remember that groups are user-defined (see Setup,
chapt. 9, par. 2.1). The group definition is necessary to correctly assign the
pathological flags and to allow the automatic repetitions (when programmed) for
the samples that fall outside the panic range.

Type: in this field select the type of sample. As every type of sample has separated parameters, it is
necessary to correctly assign this option to allow the analyzer to correctly
process the sample.

When the Urine are selected, the analyzer will display an

additional field where the operator should enter the urine volume
in the 24 hours.
Always remember that the volume unit used here and the units
entered in the analytical parameters must be related (see
chapter 3, par. 5.5. Supplementary – Note on urine units.

Birth date: entering the patient's birth date in this field, the analyzer will automatically calculate and
update the Age field (the age date field will be updated when saving, passing
with TAB or clicking on it). It is also possible to write the Age, in this case the
analyzer will calculate the Birth date (the year, day and month will be the
current). The birth date field will be updated when saving, passing with TAB or
clicking on it.

Draw date: the current date is automatically updated here. Click on the calendar icon to select a
different date or type it in the field.

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External pre-dilution factor: this field has two functions:

- allows entering a dilution factor for externally pre-diluted
samples, to correctly recalculate the result.
- allows the automatic sample pre-dilution.
These two functions are used alternatively, depending on the
programming.
If the programming is as in the picture, none of the two functions
is enabled. When ‘None or External’ is selected and External factor = 1 it means that no action will
be taken.

Total volume (µl): the total final volume that will be dispensed in the dilution cup after the automatic
dilution has to be written in the dedicated field (min 100µl – max 900µl). This field is not used in
case of no dilution or external manual dilution.
The dilution takes place with a maximum of three dispensations of diluent and sample (based on the
final volume), taking the sample first.
Ex: 1:3 dilution with final volume of 600μl
1st dispensing: 100μl diluent + 200μl sample
2nd dispensation: 300μl diluent
When the ‘Sample treatment’ is selected as diluent (verify that the Special preparation time in the
Setup is set), the diluted sample present in the dilution cup will be taken and treated as if it were the
whole sample (the programming present in the Sample Management will be regularly performed).
When saving the settings, the analyzer will check if the programmed volume is enough to perform
all tests programmed for the patient.

Inactive
Programming in this way, there is no pre-dilution and no result
recalculation

With External Factor (pre-diluted externally, manually)

In this condition, the analyzer will manage the sample for every
test as programmed in the analytical parameters (Sample
management), but the final result will be multiplied by the
external predilution factor.

With automatic Pre-dilution

Pre-dilution is performed with the programmed pre-dilution factor,
using the selected diluent among the available.
When this option is activated, the analyzer will disregard all other
sample treatments programmed in the analytical parameters of the
assigned tests. If a repetition of the sample is necessary, the
analyzer will again use only the dilution programmed in the patient
data and will skip on the Sample Management parameters. In this
example, the analyzer will dilute the sample 1:2 before performing the tests.

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Special preparation: the special preparation allows the preparation of a single cup with diluted
sample (on the basis of the set parameters), which is placed in the inner ring of the samples’ sector.
From this cup the analyzer will withdrawn the requested volumes for each programmed analysis. In
this example, the analyzer will dilute the sample 1:2 before performing the tests.

The automatic predilution (special preparation) is always performed in the inner ring of the samples
tray, in the dedicated dilution cup, which corresponds, internally, to the same patient. I.E. a sample
in A1 will have its dilution cup internally in A1.

CHARACTERISTICS OF THE SPECIAL PREPARATION

Manual repetitions with special preparation active:
If a manual repetition of the sample is necessary, the analyzer will ask whether or not to use the cup
containing the pre-dilution already performed. In case of new predilution, the cup is placed following
the guided procedure at the moment of the run test: see par. 4.3.
Also in this case any programming of the Sample Management will be ignored.
For this to happen, the following conditions are required:
1. repetition is required for a single sample (not repetition for analysis)
2. the sample had previously been pre-diluted in the cup
3. there are no sample errors
Analyzer reset with special preparation active:
At the beginning of each run, the dilution cups are prepared.
If the instrument is reset and then tests are run again, all the cups already prepared before the reset
will not be prepared again, but used.
The cups are prepared again if:
1. a patient is moved out of the worklist
2. a patient is moved from one position to another of the worklist
3. the special preparation dilution parameters are modified
The conditions described above also apply in case of manual repetition, when the operator decides
to re-use the previously prepared cups.

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SPECIAL PREPARATION DIAGRAM

SPECIAL PREPARATION ACTIVE

Diluent selection

System
solution Lysing sol.

Saline

Diluent
Running Samples

YES: samples and supplementary cups for pre-dilution and pre-treatment are already in place
NO: samples and supplementary cups for pre-dilution and pre-treatment will be placed following a guided
procedure
Following actions
Preparation of the pre-treated sample cup in the
Preparation of the pre-diluted sample cup in the samples tray inner circle.
samples tray inner circle. Incubation of the pre-treated sample (lysis) as per
Withdrawal of the sample for each analysis from the the Setup setting.
supplementary pre-diluted cup Withdrawal of the sample for each analysis from the
supplementary pre-treated cup

Use of the Sample Management Parameters

Not used (the sample is already diluted) Used normally

Automatic Repetitions
Per analyses: if the analyzer finds the sample Active
already in the cups, it stops as it doesn’t know if the
remaining sample is enough or not to perform the
repetitions.
Manual Repetitions
(per single patient) Select between the already Select between the already prepared pre-treated cup

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prepared pre-diluted cup or a new supplementary or a new supplementary cup preparation
cup preparation
Cups placamento for repetitions
Same procedure used for running samples.
In case of new preparations in supplementary cups, the already prepared cups must be removed from the
tray and replaced with a new and clean cup.
Exceptions
Some analyses assigned to the pre-diluted patient Not applicable: the untreated sample is whole blood
should not be performed with pre-dilution or should that can not be sampled by the analyzer.
be performed with pre-dilution different from that
assigned in patient entry.
In the Sample Management, check the 'Use
undiluted sample only' option: this option excludes
the programmed dilution in patient entry and
reactivates the options in Sample Management.
In the pre-treated samples (lysis) the Sample
Management does not change and is always used.

No pre-dilution is performed for this analysis (there

are no active options), regardless of the
programming performed during patient entry.

The analyzer performs a pre-dilution 1:3 (60 + 120) • In case of pre-treated samples, the
with saline solution (in cuvette) from the whole sample withdrawal capsule is
sample, only for the analysis in programming. always the treated one (inner ring)
and never the one with the whole
sample (outer ring): the check on
'Use only undiluted sample' is not
necessary.
• Pre-dilutions can be activated with
the available diluents and will be
carried out in a cuvette starting from
the treated capsule, as done for all
the other options of the Sample
Management.

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ANALYSES
As already seen for the analytical parameters, it is possible to display, when programming the
patient, the current analyses tray or all the programmed codes.
To assign the analyses to a patient, click on the test code button or on the checkbox.
Selected tests will have the check next to the code, in the check-box. To deselect the
assigned analyses, click again.

Right click on a test code to open a Description window. In this window it is possible to enter a brief
description of the test, or a note.

Figure 5-30

Right click on the I.S.E. test code to open the Select sensors/Description window.

Figure 5-31
In this window it is possible to enter a note and, only for the patient under programming, it is
possible to differently select the sensors in use.

To assign the profiles, first open the profiles list by clicking on the right side of the window, on the
Profiles bar. Click once on each profile to see the analyses belonging to it,
or double click to assign the profile to the patient.

Once profiles are assigned it is still possible to change the patient's

analyses by clicking singularly on each.
It is also possible to restart all the patient's analyses programming by
clicking on the Deselect all button. This will deselect all assigned analysis,
without changing anything in the patient data.

To move back and forth inside the work-list it is possible to use the two arrows.

When a patient programming is finished, click on the Save button and the analyzer will automatically
show the next free position.
Press Cancel to abort the programming and to go back to the work-list.

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Note on Clones
When programming clones, bear in mind that all the patient information entered in the Master
Patient will be copied in the Cloned Patients. Code, surname, name and group will be automatically
assigned. To run a relation test having in the formula analyses on serum and on urines, it will be
necessary to clone a patient and to select the relation test both for the Master patient and for the
clone patient. In the Archive every patient will have a single report, therefore Master and Clone will
not be merged in a single report.

4.2.2. Programming STATs

The urgent patients programming is done exactly as for the normal routine. A STAT patient can be
entered in two ways.
Click on an empty position and then select STAT from the Element options,
Or click on the STAT button on top on the work-list.
The same window as for the routine is displayed.
After having programmed the urgent sample, press the Save button. The analyzer will display the
following question.

The user can run immediately the sample or save it in the work-list.
If the sample is run immediately, the analyzer will ask if the sample has already been inserted in the
tray, if not, the analyzer will guide the operation in placing the cup in the correct position on the
samples tray (see par. 4.3. Running samples).
After the STAT sample has been run, the analyzer will have to complete the R1+S phases that were
already started. This means a waiting time that may vary from 0 to 6 cycles, for a maximum of 90".
After the STAT sampling is completed, the analyzer will go back to the normal routine work.

4.3. Running samples

There is more than one way to run the programmed samples.
If all programmed samples are ready to be run simultaneously, then simply
press the Run all samples button.

Alternatively it is possible to select the samples one by one, clicking on each check-box.

Figure 5-32

Then click on the Options menu, go to Selected samples and select Run.

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As already seen for batches, the analyzer will display the following message.

Answer yes if the patients’ cups and the cups for the special preparation (pre-dilution) are already
positioned in the tray, or answer no to let the analyzer guide you in the cups insertion. In this case
the analyzer will display the work-list as below.

Click on a single position and the analyzer will rotate the tray in order to insert easily the cup in the
correct position. The inserted cups' positions will turn from red to blue background. When there are
patients with the special preparation active, the analyzer will ask to place the patient cup and also
the supplementary cup for the special preparation.
It is also possible to insert/check a whole samples sectorpressing the button ‘Present sector’::

The analyzer will display a window with one button for each sector, in order to let the operator
insert/check the sectors, if necessary. Once finished, press the button ‘Accept’ to close the window
and proceed with the samples inserting.

Once all selections are done, click on the Accept button to let the analyzer start the run.

ATTENTION: After having pressed ‘Accept’, the analyzer will perform a reset of the samples tray to
verify the presence of all sectors where patients are programmed to be run. In case of failure in
recognizing a sector’s presence, the procedure will be repeated.
There may be the following conditions:
a. in the unrecognized sector there were already tests in run, all having the sample dispensing
phase completed: all the completed tests will be saved, but automatic repetitions, in case of need,
will not be performed, as the sector is not available.
b. in the unrecognized sector there were already tests in run, but the sample dispensing phase was
not completed: all tests will be ended and flagged with S (no sample).
c. in the unrecognized sector there were not tests in run: the analyzer will prevent from performing
programmed tests in the missing sector.
If a sector is present, but it is placed in the wrong position (sector B in position for sector C), the
analyzer will allow the run for the correctly placed sectors, but not for those in the wrong place.
To start the run immediately, skipping on the above mentioned procedure, answer Yes to the
question "Do you have already inserted the samples?.
The analyzer will display the following question.

The analyzer calculates the number of available tests with the volume in each reagent bottle
by checking the volume at the beginning of the run, so it is very important to answer YES
when the analyzer asks “Do you want to perform a volumes check?” (see also 2.3. Reagents
swap procedure - DYNAMIC IN SAMPLES AND VOLUMES CALCULATION)

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With the check the analyzer will update all reagents volumes and will be therefore able to swap to
the backup reagent when necessary.
The current work-list will appear in this way: the red colored samples are in run, while the blue
colored samples are already programmed, but not in run.

When the bar-code reading is active (see bar-code settings in chapter 9, par. 1.4), the patients
samples can be placed directly on the tray for positive identification.
When the tubes are positioned, click on the Options menu of the Current list, select Bar-code and
then one of the available commands for running samples: see next par. 4.4.

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4.4. Current and Extra work-lists

When entering the patients, it may be useful to have a supplementary list where these can be stored
until the sample cup or tube is available. In the Extra list it is possible to move all the patients
programmed in the Current list and also to add many more samples. The characteristic of the
samples in the Extra list, is that they do not have an assigned position on the samples tray,
therefore, when receiving the sample tube, it can be placed anywhere and in the most convenient
position among the available free.
The patients present in the Current list can be moved to the Extra list and vice versa.
Samples in the Current worklist are programmed 10 per sector. It is possible to run one sector (or
more) at a time, while other sectors are removed from the samples chamber to be loaded with cups
or tubes. In the Current list Options menu, there are the following functions.
Select and Deselect All: these two functions allow the operator to
select or deselect all programmed patients.
Print all samples: this line opens the printing interface (see chapt.
3, par. 2.1). From this interface it is possible to print on paper, export
or save in a pdf the current list. Here also the minimum required
sample volume, calculated on the programmed analyses, is
indicated.
Insert sectors: allows entering one or more sectors, in the samples
chamber. This option is useful to program patients in any position,
then run one sector at a time as soon as each sector has been
loaded with the samples. Once the function is activated, the analyzer will ask to insert the sector,
then will perform a samples tray reset to read which sector has been inserted. At this point it will be
possible to run the patients programmed in the present sectors.
If a run is launched but not all sectors already programmed are present, the analyzer will warn the
Operator that only some sectors are present.
Selected samples: this option opens another menu where there are the functions dedicated only to
the selected samples.
The already selected samples (all together or one by one) can do one of the following.
Move to extra list: the samples are moved to the extra work-list for future use.
Print: opens the printing interface (see chapt. 3, par. 2.1).
Run: the selected samples are run.
Delete: the selected samples are deleted. A question will ask for confirmation before deleting.

Bar-code: when the bar-code on samples is enabled, clicking on this line will open another menu
with the following functions.
Scan all tray: starts a reading of all bar-coded tubes on the samples
tray.
Scan single position: reads the bar-code in a position selected by the
operator.
Scan all tray and run: makes a bar-code reading and starts the run of
the positively identified samples. Errors, if present, will be displayed on
the screen.
Scan single position and run: makes the bar-code reading of a
selected position and runs the sample.

Extra list Options. In the Extra list options, the functions are similar to those seen for the Current
list. The Run line is not available as the extra is a storage list with no
position assigned.
When using the bar-coded tubes and the Host computer, it is
possible to send the work-list from the Host and to use it immediately
or to store it into the Extra list. When the tubes are introduced into
the samples tray they are read with the bar-code reader. The
analyzer will match every read code ID with those present in the
Extra list and will move only these samples to the current list for running.
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Selecting the function Move to current list, it is possible to select the position of the current list
from which to start placing the list of selected patients of the
extra list. First put the check on the samples to be moved, then
select the Move to current list function. After confirming the
command, a window will appear where it is possible to select
the starting sector and position.

4.5. Samples Performed work-list

While the analyzer is working, the samples results are available in the real time pages.
The Results RT page displays all test results as they arrive.
The Results page displays the results per sample as soon as the
whole sample is finished. In this page it is also possible to save results into the archive. Once
results are archived, the Samples performed list will be cleared (see also chapt. 8).
The Samples performed list stores all the information of the performed tests, including the reaction
graph which is not available in the archive.
Every patient is color-coded. The red background means that there are flags, the yellow background
means that something was missing during the sampling (sample, reagent), the blue background
means that all sample results are correct. The text in italic means that the sample is in repetition or
that it is a clone.

It is possible also to view all the test results and reaction graphs by double clicking on the sample's
code. In this case, the analyzer will open a window like the following.

Figure 5-33
On the left side there are the patient's data, while on the right side are listed the performed tests
with their own result. The red background indicates the presence of flags for the test.
From this page it is also possible to program the repetition of some of the patients’ analyses. See
following text for further information.

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Next to each code there is also a small icon representing a graph. Click on this icon to view the test
graph.

Figure 5-34

The same information that are shown clicking the Graph icon in the main icons bar are shown here,
but these info refer strictly to the selected test belonging to a specific patient. In the upper part of the
window there is the reaction graph. On the left there are the absorbances read, with the cycle they
were read at. On the lower part of the window there is a summary of the reaction the information
and the information used for calculation. The Print button opens the printing interface (see chapt. 3,
par. 2.1).

To repeat a single sample, there are two options:

1. click on the numerical position of the tray

2. double click on the patient’s code

In the first case, the analyzer will show the original position of the sample, if available, or the first
free position. The operator has the possibility to change the position if necessary.

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Once the position is saved, the analyzer will open the sample data window. Patient's private data
fields will be closed. It is possible to add or remove tests or change
the external pre-dilution field.
Make the necessary changes and save. The patient will be copied
into the current list and identified in italics (repetition).
When running already performed samples, the analyzer will ask ‘Do
you want to perform also the completed tests?’. Answering Yes, the
analyzer will repeat also the tests which have already a result in the
Performed patients list; answering no, the analyzer will run only the
remaining tests and the tests that have been added to the patient
when requesting the repetition.

In the second case, after having doubled clicked on the patient’s ID code, it is first necessary to put
the check on the desired
analyses, then click on
Repetition. The analyzer will ask
for confirmation, then will show
the patient's original position, if
available, or the first free position
on the current list (sector and
position). Once the position is
selected and saved, the analyzer
will show the patient’s data window as in the first case. The analyses already selected for the
repetition will have the check mark. It is possible to add or remove tests or change the external pre-
dilution field.
Make the necessary changes and save. The patient will be copied into the current list and identified
in italics (repetition).

Once samples are performed, it is also possible to repeat a group samples all together, using the
Options command in the Patients Management main menu bar. See following par. 4.6.1.
Repetitions for analyses.

On the left side of the Samples Performed bar, there is a search box. This can be used to easily
search for a performed code. Just type the first characters (or the whole code) of the code you're
searching for and click on the small "gears" button. All codes starting with the typed characters will
be displayed.

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4.6. Patients Management Options

The Patients Management window has an Options menu, where a few commands are available.

New Entry: this command will open the Samples Data window for
programming a new patient.
Close: this command will close the whole Patients management window.

4.6.1. Repetitions for analyses

This option allows the repetition of the patients, selecting the test codes and then selecting which of
the samples will have to be repeated. This function is useful, for instance, when a test runs out of
reagent and the corresponding patients are all flagged with "R".
After clicking on the command, the analyzer will
display the following window. Here are listed all the
already performed test codes.
Select the test codes to be repeated by clicking on
the checkboxes.
It is also possible to Select / Deselect all the codes
by clicking on the appropriate buttons.
Once finished the codes selection, click on the
Accept button.

The analyzer will display the codes window.

Here are listed the patient's codes available for the

already selected tests.
Click on the checkboxes to select the codes or use
the Select / Deselect commands.
Once finished, click on the Accept button.
At this point the analyzer will ask the following
question:

Answering YES, the analyzer will place the

selected samples again into the Current list, in the
positions the same samples occupied in the first
run.
In case the positions are already programmed with other samples, the analyzer will place the
repetitions in the first free positions.

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5. TURNING OFF PROCEDURE

To turn off the instrument, the shut down procedure must be performed. It is a software guided
procedure. Once the analyzer program has been turned off, it is also possible to turn off also the
analyzer by means of the ON/OFF button. This will fully turn off the analyzer, including the
refrigeration. If the analyzer program is closed, but the analyzer is still turned on, the lamp will be
turned off as well as the cuvettes heating. The refrigeration and the I.S.E. will still be on.
The shut down procedure proposes the daily washes with appropriate solutions before turning off.
Follow the analyzer instructions. Daily as weekly washes, as well as the normal maintenance must
be performed on the operator's responsibility.

Switch-off analyzer + PC: with this command, the analyzer

program will be closed, but it will also close the operative system
and the whole PC.

Exit from the program: with this command, only the analyzer
program will be closed. The PC will remain turned on.

(Suspend activity and Log-off have been described at Chapter 3, par. 2, at Utility menu)

NOTE: if cuvettes are not properly washed at the shut-down, at the following start up the analyzer
will ask for the cuvettes extra wash. Performing the normal cuvettes wash (with the proper solution)
will not prevent the analyzer from warning again that the extra wash is needed.

5.1. Long-term Turning Off Procedure

If the analyzer has to be turned off for more than three days, it is advisable to perform one of the
following procedures instead of the normal shut-down procedure, followed by an Empty fluidics.
- perform an Extra wash cuvettes
- perform a Wash cuvettes followed by a Wash and fill-up with system solution
At the end of these procedures, run an Empty Fluidics procedure, then turn off the analyzer and
take care to put in place all covers (reagents tray cover, samples tray cover, cuvettes cover). Unplug
the analyzer and disconnect all peripherals, disconnect the UPS and turn it OFF, cover the analyzer
with a suitable cloth.
This procedure will leave the cuvettes and the hydraulic circuits dry and clean.

For the I.S.E. systems, a wash is always advisable. Read the dedicated chapters for further
instructions.

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CHAPTER 6
QUALITY CONTROLS
1. QUALITY CONTROLS

This is an external program used to enter, change and process quality

controls. The program can process data from the analyzer (controls run in
routine or dedicated positions) and from other instruments (with the New
function). The Quality Controls (Real Time) is the archive where the newly
performed controls (not yet saved) can be displayed, together with the already
saved QCs, using the QC statistical elaboration.

Figure 6-1

As all the external archives, the QC has a backup function. It is advisable to perform a periodical
backup of the archive, every 3 or 6 months, depending on the amount of data which are present in
every archive. The backup file format is not readable by a program different from the Analyzer.
It is also possible to export the archives in different file formats as pdf, rtf and csv (see Chapter 3,
par. 2.1 Printing interface) that can be easily read with an appropriate program on the PC.

From the Data menu it is possible to enter external QC data, view the QC stored
data and also the Youden graph.

In the Utility menu, there are the Backup and Restore functions, together
with the Manage external data and Delete data functions.

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1.1. New data

Here it is possible to process data obtained externally from the analyzer. It requests a series of
information used to statistically process the inserted
values.

To enter a new name in the Analyses, Lot and

Method field, click on the button.

In the appearing field, type the requested

information and save.

Analyses: insert a name for analysis or select one

from the existing list.
Method: insert a method or select one from the
existing list.
Lot ID#: insert the lot number or select one from the
existing list.
Level: select the level to assign the correct range.
Type: select if the control is a known or unknown
type.

Test date: enter the date in which the test was performed.
Test time: enter the time when the test was performed.
Result: enter the known data.

When the button Save is pressed, the control range window will appear. Type the control range for
the selected type and level and save with the button Yes.

At this point statistical processing of the data becomes available.

Data inserted manually will be managed exactly like the data from the analyzer.

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1.2. Manage data

In this page it is possible to view, make searches with, and print the QC data.
To obtain data processing it is necessary to
provide the analyzer with all the information
related to the control: Analysis, Method, Lot
ID#, Level and Type – Known/Unknown.
If the All option is left in the Lot and Method
fields, the search will be done for all the lots
and all the methods relative to the test
selected in the Analyses field. In this
condition the Range and Westgard Decision
values will not be displayed.
Data searches can be run for a single date or
for an interval of dates. Use the From date
and To date fields to select a single date or a date interval.
Select ‘Cumulative’ to see the mean of the values for each date.
Make all the selections necessary for processing the data, then press the Search button.
The results will be displayed as a list. The data are ordered by date and time. Out of range controls
are indicated with an asterisk and have red background.

Figure 6-2

In the QC in Real Time, the new controls have green background.

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To delete a record, refer to the Delete data at paragraph 1.4.

When the search is run on unknown controls the range and Westgard classes are not displayed.

1.2.1. Westgard graph

Click on the dedicated button.

Figure 6-3

The Westgard graph provides a global vision of a given lot by plotting data on a diagram having the
origin at 0 line representing the lot mean value, calculated as (lot min + lot max)/2, which usually
corresponds to the lot theoretical value. As division, are reported values such as Mean±1S ±3S. All
data within the given range will be displayed with a green circles while the out of range data will be
plotted using red circles.
It is a procedure for classifying values of a Known lot taken into consideration for processing.
Mean: mean between the maximum and minimum lot value
S: (Maximum lot value – Minimum lot value) / 6
The following procedure is observed for classification:

Class A (1-2S): One result exceeds Mean by +/- 2S.

Class B (1-3S): One result exceeds Mean by +/- 3S.

Class C (2-2S): Two consecutive results exceed mean by 2S in the same direction.

Class D (R-4S): Difference between two consecutive results is higher than 4S and at least one
result exceeds mean by +/- 2S.

Class E (4-1S): Four consecutive results exceed mean by more than 1S in the same direction
and at least one result exceeds mean by +/-2S.

Class F (10x): Ten consecutive results are all in the same direction of the mean value and at
least one result exceeds the mean by +/- 2S.

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Classes are controlled from F to A. The classes are mutually exclusive, that is, if a given value is
mapped to one class then it can't be part of another class.

Example:
2 E classes means that 5 consecutive results exceed Mean by more than 1S in the same direction
and at least one result exceeds mean by +/-2S; alternatively two groups of 4 consecutive results
exceed the mean by more than 1S in the same direction and at least one result exceeds mean by
+/-2S.

Click on the Print button to print the graph and/or to export it (see printing interface chapt. 3, par.
2.1).

1.2.2. Levey-Jennings graph

Click on the dedicated button.

Figure 6-4

The Levey-Jennings graph provides a global vision of a given lot, plotting data on a diagram having
the following information represented all together in the same graph:
- Mean: calculated controls mean (continuous line in the center)
- Control Lot mean value (dashed line in the center)
- calculated standard deviations intervals (dotted lines)
- Control lot Minimum and Maximum values (red dashed lines at the extremes)
All data within the range will be represented by a green circle, while the out of range data will be
plotted using red circles.
The Levey-Jennings graph displays the same information as the Daily Chart, with the addition of the
Control lot Mean value. In this graph the query can be for one single lot at a time only and is not
available for unknown controls.
Click on the Print button to print the graph and/or to export it (see printing interface chapt. 3, par.
2.1).

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1.2.3. Daily chart

Click on the dedicated button.

Figure 6-5

The Daily Chart graph provides a global vision of a given lot, plotting data on a diagram having the
origin represented by the actual mean (not by the theoretical value) of the same lot and as divisions
values such as Mean+Standard Deviation*1, Mean+Standard Deviation*2 to Mean+Standard
Deviation*4. In addition the red dashed lines indicate the upper and lower limits of the lot. All data
within the range will be represented by a green circle, while the out of range data will be plotted
using red circles.
Click on the Print button to print the graph and/or to export it (see printing interface chapt. 3, par.
2.1).

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1.3. Youden graph

Figure 6-6

After selecting the general search parameters Analyses, From Date, To Date, choose the specific
Level, Lot ID#, Method for the X and Y axes. Data processing and visualization is performed
pressing the button Search. The controls are ordered by date and in case of known controls the Out
of limit condition is indicated.
This function relates two different levels for the same lot displaying distribution of controls within the
limits of lots.
Click on the Print button to print the graph and/or to export it (see printing interface chapt. 3, par.
2.1).

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1.4. Utility
The UTILITY menu contains a few functions: the backup, the restore
Backup: it is used to make a backup copy of the present archive. The
exported archive can be restored in any moment, but it will overwrite the
existing QC archive. The backup function will keep a copy of the archive in
a safe place (the files can be copied in any other location or PC). It is
advisable to make a backup every 3 to 6 months and to delete completely
the QC archive every time a backup is performed. An important alternative
is to use the export functions available in the printing interface chapt. 3, par.
2.1

To perform a backup it is first necessary to

select the desired criteria for listing the
controls. If a backup of the whole archive is
desired, open the Backup and then click on
the button Search, leaving in all fields the
default values.
The selected controls will be listed in the
window. Click on the Backup data button. A
window will
appear where it
will be possible to
select the location
for saving the QC
archive backup.

Figure 6-7

Restore: the restore function will import and overwrite the present archive with one of the available
backup.

The backup and restore functions are very important as every PC may face memory or hard disk
problems. In this cases it is possible that the archives are lost or damaged. A copy of the archives
stored in another PC or any other device, different from the analyzer's PC may allow the total
restoration of data.

Manage external data: this function allows to view an exported archive (backup) without restoring it
into the analyzer's HD.
Select the location where the archive was saved and open it.
The Manage external data sentence will be displayed on the
main title bar and in the Utility
menu there will be the check
sign indicating that the analyzer
is dealing with the External
data. Once the external archive
has been loaded, just click on
the Manage data button to view
it, exactly as is normally done
with the internal archive. To go
back to the internal archive, just remove the check sign by clicking again on the Manage external
data line.

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Delete data: data in the archive can be deleted with the same search criteria already seen in the
backup search. It is possible to delete the whole archive
performing a search leaving in the criteria fields all the
default values. Otherwise it is possible to perform a
search by lot number, by date, etc..

Exit: this function will close the QC archive.

2. QUALITY CONTROLS IN REAL TIME

The QC in real time allows to view the just performed controls, together with the controls already
stored in the QC archive. This program has the same functions as the QC archive, but does not
allow entering new data, deleting data, exporting or importing data, etc…
In the QC in Real Time, the new controls have green background.

Figure 6-8

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CHAPTER 7
EXTERNAL ARCHIVES
1. EXTERNAL ARCHIVES
The External Archives are: Patients Archive, Population Archive, Quality
Controls, Calibrations Archive and Quality Controls in Real Time. The
two Quality Controls archives are explained in Chapter 6.
With the exception of the QC in real time, all the external archives have a
backup function. It is advisable to perform a periodical backup of the
archive, every 3 or 6 months, depending on the amount of data which
are present in every archive. The backup file format is not readable by a
program different from the Analyzer.
The backup and restore functions are very important as every PC may
face memory or hard disk problems. In this cases it is possible that the archives are lost or
damaged. A copy of the archives stored in another PC or any other device, different from the
analyzer's PC may allow the total restoration of data.
It is also possible to export the archives in different file formats as pdf, rtf and csv (see Chapter 3,
par. 2.1 Printing interface) that can be easily read with an appropriate program on the PC.

2. PATIENTS ARCHIVE
The Patients Archive module stores the
patients reports. For every patient the given
personal information are saved together with the
analyses results, possible flags and notes.
It is possible to perform searches in the archive,
based on different criteria.
The archive can be exported, copied as internal
backup, viewed as external archive, deleted and
printed.
In the archive main page there are two main
menu: Utility and Data. Two buttons allow:
entering in the Manage page and Exit from the
archive.

2.1. Manage data

In this page it is possible to view all performed
patients or to make a patient search using the
available criteria.
The Manage Data page has also the following
menu: Functions and Sort Order (see
following paragraphs).

Figure 7-1

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The patients in the Archive can be searched for, with a certain number of criteria:
From code / To code: indicate the first code and the last code within which the search must be
performed.
Surname / Name: these options are useful when searching for a known patient.
From date / To date: allows to select a range of dates within which the analyzer can search
patients data.
Once the criteria are specified, click on the button Search. To repeat the search with different
criteria, click on Clear search.

Leaving all fields unchanged (default values), and clicking on the Search button, the analyzer will list
all available patients.

When patients are listed, click on one line to view that patient's data and results in the right side of
the window. The tests with red background also have an asterisk to remember there is a flag.
Double click on one of these red lines to read the flag.

Select a patient from the list.

View the patient's data.

Figure 7-2

Double click on one red background test.

For printing reports, see the following paragraph.

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2.1.1. Functions and Sort Order

Print: allows the operator to print a single patient or all the
patients belonging to the present query. The print function
introduces to a number of other options, as already explained in
Chapt. 3, par. 2.1 Printing interface. Among these options there is
the possibility to export the patient/archive as csv or pdf file
formats.

Example of a patient printout.

Figure 7-3

Send to host: this function allows the operator to send to the

host computer the selected patient or all the patients belonging to
the performed search.
NOTE: this function may be very slow. Sending more than 30
patients may require some minutes to be completed.

Administrator: this function is under password. The Administrator

can view the users that have performed the tests.

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Sort order: the patients can be listed in a specific order, that can be
decided by the operator.
The available options are: by code (alphanumeric order), by Draw date
or by Surname. With the None option, patients will be listed by date.

2.2. Utility and Data menu

The UTILITY menu contains a few functions: the backup, the restore and the
delete data.
Backup: it is used to make a backup copy of the present archive. The exported
archive can be restored in any moment, but it will overwrite the existing archive.
The backup function will keep a copy of the archive in a safe place (the files can
be copied in any other location or PC). It is advisable to make a backup every 3 to
6 months and to delete completely the archive every time a backup is performed.
An important alternative is to use the export functions available in the printing
interface chapt. 3, par. 2.1

To perform a backup it is first necessary to

select the desired criteria for listing the patients.
If a backup of the whole archive is desired,
open the Backup and then click on the button
Search, leaving in all fields the default values.
The selected patients will be listed in the
window. Click on the Backup data button. A
window will appear where it will be possible to
select the location for saving the archive
backup.

Restore: the restore function will import and

overwrite the present archive with one of the
available backup (see also Data menu for
viewing external archives).

The backup and restore functions are very important as every PC may face memory or hard disk
problems. In this cases it is possible that the archives are lost or damaged. A copy of the archives
stored in another PC or any other device, different from the analyzer's PC may allow the total
restoration of data.

Delete data: data in the archive can be deleted with the same
search criteria already seen in the backup search. It is possible to
delete the whole archive performing a search leaving in the criteria
fields all the default values. Otherwise it is possible to perform a
search by code, by date, etc..

Exit: this function will close the archive.

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The DATA menu offers, besides the possibility to open the Manage data
window, also the Manage external data option. This function allows to
view an exported archive (backup) without restoring it into the analyzer's
HD.

Select the location where the archive was saved and open it.
The Manage external data sentence will be displayed on the
main title bar and in the Data menu there will be the check
sign indicating that the analyzer is dealing with the External
data.
Once the external archive has been loaded, just click on the
Manage data button to view it, exactly as is normally done with
the internal archive. To go back to the internal archive, just
remove the check sign by clicking again on the Manage
external data line.

3. POPULATION

The Population module stores all test

results performed by the analyzer.
New tests can be manually entered and
the Population archive can perform the
desired statistical elaboration also on
these data.
It is possible to perform searches in the
archive, based on different criteria.
The archive can be exported, copied as
internal backup, viewed as external
archive, deleted and printed.
In the archive main page there are two
main menu: Utility and Data. Three
buttons allow: entering in the Manage page, entering in the New page and Exit from the archive.

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3.1. New data

With this option it is possible to process data obtained
externally from the analyzer. It requests a series of
information used to statistically process the inserted
values.

To enter a new name in the Analyses and Method field,

click on the button.

In the appearing field, type the requested information

and save.

Analyses: insert a name for analysis or select one from

the existing list.
Method: insert a method or select one from the existing
list.
Figure 7-4

Group: select the correct one from the existing list.

Type: select sample type.
Test date: enter the date in which the test was performed.
Result: enter the known data.
Press the Save button and go ahead with the following result. Close when finished. At this point
statistical processing of the data becomes available.
Data inserted manually will be managed exactly like the data from the analyzer.

3.2. Manage data

In this page it is possible to view all performed tests
or to make a data search using the available criteria.
The Population can be searched for, with a certain
number of criteria:
Analyses: choose one of the analyses available in
the list
Method: select the method.
Group: choose a group among those available.
Type: choose a sample type
From date / To date: allows to select a range of
dates within which the analyzer can search data.
Use numeric range: this field is optional. Activate
the checkbox to enable also a search performed
between the extremes of a numerical range.

Once the criteria are specified, click on the button Search. To repeat the search with different
criteria, click on Clear search.

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Leaving all fields unchanged (default values), and clicking on the Search button, the analyzer will list
all available data.
The statistics related to the search will be displayed in the
colored area on the right side of the window. The analyzer will
calculate:
Number of (selected) records
Minimum result
Maximum result
Mean
Standard Deviation
Correlation coefficient
Variation coefficient
Variance
Deviance
Median

The performed search can be printed or exported (see printing interface chapt. 3, par. 2.1), by
clicking on the Print button.

It is possible to print only the statistics or these and the search data, as in the above example.

The search can also be plotted on a graph.

Click on the Graph button. The analyzer will freeze all the search criteria fields and will show the
following buttons for selecting the type of graph to be displayed.

Figure 7-5

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The Data Sequence graph simply shows the data in a sequence.

The Trender graph shows the data sequence together with its related minimum square line in the
lower part of the graph the equation for the line is shown.

The L. Jennings graph shows data plotted with the mean and the standard deviation.

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The Histogram graph shows a simple histogram of the selected data.

The Statistic Histogram graph shows the histogram for the selected data with respect to the mean
value, used as origin line.

The graphs, with the related statistical data,

can be printed with or without the List of data.

Figure 7-6

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In every search it is possible to delete one or more records. It is also

possible to delete the whole search.

3.3. Principal Statistics Formulas Used In Population

Mean:

X: X1 ..Xn selected elements; being "n" the number of elements:

X1 + X2 + … + Xn
X=
n

Standard Deviation:
SD: is a quantity that measures the spread of data across its mean value. If data is mostly located
near the mean SD assumes a small value, otherwise a large value indicates large data spread.
Σn (X – X) 2
DS = i
i=
n-1

Variation coefficient:
CV%: is computed as the ratio between mean square error and arithmetic mean. CV% is a relative
quantity and independent from the measurement unit used.

DS*100
CV=
X

Minimum square line y = ax + b

Where: Σ XY-nΣxΣy
a=
Σ X2 - n(ΣX)2
b= ΣY-aΣx
Correlation Coefficient:

Σ[(Y-Y)*(X-X)]
CC =
Σ(X-X)*(Y-Y)
Variance:

[ΣX*ΣX]
ΣΧ2 -
n
V=
n-1

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Deviance:
(ΣX) 2
2
D =Σ X - n

Median:
The Median for an ordered ser of data is the central value or the arithmetic mean of the two central
values, depending on the fact that the number of elements in the set be odd or even. In particular
the median for N odd elements, is the X[(N+1)/2]th element.
Example.: given the following 9 elements set
1, 2, 2, 17, 21, 34, 34, 34, 67

Median = [X (N+2)]/2 = X[(9+1)/2] = X[5] = 21

median is 21, the fifth element.

The median for N even elements, is the { X(N/2) +X[(N+2)/2] }/2 element.
Ex.: be given the following 8 elements set
1, 2, 12, 24, 26, 45, 45, 46
{X[4]+X[5]}/2 = (24+26)/2 = 25
median is 25.

By comparing the median and the arithmetical mean, one can assume the existence of a
measurement error or an asymmetry in the distribution function, in case these two quantities differ
greatly.

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3.4. Utility and Data menu

The UTILITY menu contains a few functions: the backup, the restore
Backup: it is used to make a backup copy of the present archive. The exported
archive can be restored in any moment, but it will overwrite the existing archive.
The backup function will keep a copy of the archive in a safe place (the files can
be copied in any other location or PC). It is advisable to make a backup every 3 to
6 months and to delete completely the archive every time a backup is performed.
An important alternative is to use the export functions available in the printing
interface chapt. 3, par. 2.1

To perform a backup it is first necessary to

select the desired criteria for listing data. If a
backup of the whole archive is desired, open
the Backup and then click on the button
Search, leaving in all fields the default
values.
The selected data will be listed in the
window. Click on the Backup data button. A
window will appear where it will be possible
to select the location for saving the archive
backup.

Restore: the restore function will import and

overwrite the present archive with one of the
available backup (see also Data menu for
viewing external archives).

The backup and restore functions are very important as every PC may face memory or hard disk
problems. In this cases it is possible that the archives are lost or damaged. A copy of the archives
stored in another PC or any other device, different from the analyzer's PC may allow the total
restoration of data.

Delete data: data in the archive can be deleted with the same
search criteria already seen in the backup search. It is possible to
delete the whole archive performing a search leaving in the criteria
fields all the default values. Otherwise it is possible to perform a
search analyses, by date, etc..

Exit: this function will close the Population archive.

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The DATA menu offers, besides the possibility to open the New Data and
Manage data windows, also the Manage external data option. This
function allows to view an exported archive (backup) without restoring it into
the analyzer's HD.

Select the location where the archive was saved and open it.
The Manage external data sentence will be displayed on the
main title bar and in the Data menu there will be the check
sign indicating that the analyzer is dealing with the External
data.
Once the external archive has been loaded, just click on the
Manage data button to view it, exactly as is normally done
with the internal archive. To go back to the internal archive,
just remove the check sign by clicking again on the Manage
external data line.

4. CALIBRATIONS ARCHIVE
The Calibrations archive stores all the
performed chemical calibrations,
including I.S.E.
In the archive main page there are two
main menu: Utility and Data. Two
buttons allow: entering in the Manage
page and Exit from the archive.

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4.1 Manage Data

Clicking on the Manage Data button, the search window will be displayed.

Figure 7-7

It is possible to search for a specific calibration using the available search fields.
Analyses: select, among the available, the desired test.
Lot ID#: select the specific lot number
User: select the user that was logged on at the time the calibration was performed.
From date / To date: select the range of dates you want the search to be performed in.
If no search criteria is selected, the analyzer will display the full list of performed calibrations.
The list of the performed calibrations will be displayed on the left side of the window, with the
following information.
Analyses: test codes
User: is the user name of the operator that was logged on when the calibration was performed.
Lot ID#: is the calibrator / standard lot number as assigned at the moment of the calibration.
Test date: is the date when the calibration was performed.
State: indicates if the calibration was passed or not passed. The asterisk indicates the calibration
with errors.
The not passed calibrations will also have red background.

Click on one line and the analyzer will display, on the right side of the window, the corresponding
calibration data, including the calibration factor, the standard concentrations and the absorbances
read for each calibration point.

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4.2. Utility and Data menu

The UTILITY menu contains the backup and the delete data functions.
Backup: it is used to make a backup copy of the present archive. The backup function will keep a
copy of the archive in a safe place (the files can be copied in any other location or PC). It is
advisable to make a backup every 3 to 6 months and to delete completely the archive every time a
backup is performed. An important alternative is to use the export functions available in the printing
interface chapt. 3, par. 2.1
To perform a backup it is first necessary to select the
desired criteria for listing the patients. If a backup of the
whole archive is desired, open the Backup and then
click on the button Search, leaving in all fields the
default values.
The selected patients will be listed in the window. Click
on the Backup data button. A window will appear where
it will be possible to select the location for saving the
archive backup.
The backup function is very important as every PC may
face memory or hard disk problems. In this cases it is
possible that the archives are lost or damaged. A copy
of the archives stored in another PC or any other device, different from the analyzer's PC may allow
the total recollection of data.

Delete data: data in the archive can be deleted with the same
search criteria already seen in the backup search. It is possible to
delete the whole archive performing a search leaving in the criteria
fields all the default values. Otherwise it is possible to perform a
search by code, by date, etc..

Exit: this function will close the archive.

The DATA menu offers, besides the possibility to open the Manage data window, also the Manage
external data option. This function allows to view an exported archive
(backup) without restoring it into the analyzer's HD.

Select the location where the archive was saved and open it.
The Manage external data sentence will be displayed on the
main title bar and in the Data menu there will be the check
sign indicating that the analyzer is dealing with the External
data.
Once the external archive has been loaded, just click on the
Manage data button to view it, exactly as is normally done
with the internal archive. To go back to the internal archive,
just remove the check sign by clicking again on the Manage
external data line.

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CHAPTER 8
DISPLAYING AND PRINTING RESULTS
1. DISPLAYING AND PRINTING RESULTS
In the analyzer main page, there are three buttons
dedicated to the displaying of results.

Results: this button will open the pages where the patients results in real time are displayed. This
page is updated every time a patient is completed and is the only RT page that includes other
commands.
Results RT: in this page all results, independently from the patient to whom they belong, are
updated as soon as every test is completed.
Graph: this page shows all the available test graphs.
Calibrations and controls are listed in these pages together with the test results. Calibrations are
written with green text and controls are written with blue text.

1.1. Results page

Figure 8-1

In this pages are updated the information related to patients, calibrations, controls and possible
errors that occurred during execution.
If there is no data the page appears blank. A color code makes it possible to quickly identify the
information:
red text: presence of flags in at least one test of the sample
blue text: controls
green text: calibrations
black text: no anomaly in the test or the entire sample
It is a brief representation of data and allows visualization of results of patient in execution as the
tasks for the single patients are completed.
Once the results are archived, the information present in this page will no longer be available.

At the bottom of this page there are the following buttons:

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The following information are displayed for each sample:

a) Sample Position (#XX) Physical position of the sample in the samples tray or in the standard
& controls tray.
b) Sample Code Patient ID#, batch or autobatch number, standard or control code..
c) Surname, Name Patient’s personal data.
d) Sample Type Between parenthesis it is indicated the type of sample, whether
Routine, STAT, control or standard type.
e) Date and time Indicates when (date and time) the sample was performed.
f) Results The patients results are represented as follows:

- full name of the analysis

- method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)
For automatic re-runs the values of the first and second determination are represented.

<NC> WRITTEN INSTEAD OF THE RESULT

Sometimes it is possible to read <NC> “not calculable” in place of the value. This refers to values
that cannot be calculated for one of the following errors during the result elaboration:
- no serum
- no reagent
- no washing solution
- no diluent
- no solution (I.S.E.)
- incorrect parameters
- expired reagent
- inverse curve
<NC> results can normally be archived (only in the patient archive) with the other results (see
chapter 9, par. 2.2.) or they can be stored in the work lists to let the operator re-run the sample as
soon as possible. In this case, the patient with the <NC> result will be regularly archived and a copy
will be left in the work lists.
<NC> only appears on the result page in real time, it will be replaced by a series of dots “….” in the
patient archive.

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At the top right of the Results page there is a small button Info flags.
Click here to see a summary of the flags that are used in the Results page (see also par. 1.4).

Figure 8-2

At the bottom of the Results page there are more useful buttons.

Print: click here to print the Results page. This button will open a printing interface as already
described in Chapter 3, par. 2.1 Printing interface. It is possible to print per single sample, but it is
not in report format.

For Analyses: with this button the analyzer will arrange the results per test instead than per patient.

Adjust: this function allows results recalculation. Note that recalculated results will be flagged with
the additional flag E.
The Adjust button gives the following choices.
With standard: this function will re-calculate the results in case there is a new calibration available.
The analyzer runs the recalculation starting from the absorbance memorized for the test, thus the
various analytical parameters and the last valid
calibration are taken into consideration. In this
case, if the instrumental factor and shift have
been set in the analytical parameters, they will
be used in calculating the new value.

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With factor: this correction is performed in percentage and may be increasing as well as
decreasing.
Once the type of correction, with factor, has been selected,
the analyzer will display the analyses that can be re-
calculated.
Click on one code to open the correction window.

Select the percentage of the re-calculation and then if it

has to be in increment or in decrement.
On the right side of the window are shown the available
type of tests: routine, STAT, control. It is possible to decide
the re-calculation for one or all of them.
Once all decisions are taken, click on the Accept button.
The analyzer will re-calculate the results and will flag them
with the E flag.

With standard (only if performed with backup reagent): this type of correction is performed when
a certain number of tests have been performed with the backup reagent and a calibration with the
backup reagent was not performed before using the backup bottle itself. In this case it is possible to
run a calibration, after the test results, and to recalculate the results (flagged with K – performed
with backup reagent) with this new calibration.

Store data: Click this button to save the results into the patients archive. Bear in mind that once the
results are archived, the graphs are not available anymore. Therefore, it is a good idea to print any
pertinent graph before archiving data.
It is possible to save all results or to save data for a selected group of samples.

In the same way, it is possible to decide whether to archive also the not completed samples.

If the uncompleted samples are not stored, they will remain in the work-list (with all analyses
programmed, not only the not completed) in order to be run and completed in a second moment.
NOTE: before storing data, verify that the not completed samples are effectively in the routine
worklist. If not, move them into the routine worklist from the Performed patients list (see chapt. 5
Par. 4.5). Once these samples are completed, they can be stored into the archive, but bear in mind
that the repetitions are stored as separate reports, having the same ID number (unless the operator
has changed it).

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Clicking on the Select samples line, the analyzer will show the following window. Here it is possible
to select the single patients by means of the check sign next to the ID code. There is also a small
arrow near each code. Click on this arrow to view the list of tests performed for that sample. With
this option it is possible to select, not only the sample, but also the single test, per patient, that has
to be stored.

Figure 8-3

Attention: the analyses results, belonging to a single patient, which have not been selected, will not
be stored and will be deleted. All pertinent information will be lost. The entire patient which has not
been selected for being stored, will remain in the RT pages and in the Performed Patients list.

Clear: click on this button to delete all results in this page. All data will be definitively lost.

Sort: click on this button to arrange the results with the criteria selected in the Setup (see chapter 9,
par. 2.3.).

Close: click here to close the results window.

NOTE: once the results are archived, the information present in the results page will no longer be
available.

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1.2. Results RT page

Figure 8-4

The data refer to the results obtained by the analyzer in real time, i.e. as the tests are completed.
For this reason the results of tests with a shorter incubation and reading time may appear first even
if they belong to later patients. The results are not sorted in any way, not per patient, not for type of
test. The data display is synthetic.
Once the results are archived, the information present in this page will no longer be available. The
results of tests associated to flags are shown in red.

The following information are displayed for each single test:

a) Sample Position (#XX) Physical position of the sample in the samples tray or in the standard
& controls tray.
b) Sample Code Patient ID#, batch or autobatch number, standard or control code..
c) Sample Type Between parenthesis it is indicated the type of sample, whether
Routine, STAT, control or standard type.
e) Date and time Indicates when (date and time) the sample was performed.
f) Results The patients results are represented as follows:

- full name of the analysis

- method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets)

With the Print button it is possible to print this page, and with Close it is possible to close the page.

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1.3. Graphs page

The page that opens displays the first available graph. The graphic pages are available only after
test runs and before data are stored in the archives.
Graphs pages are divided into three parts: one shows the reaction graph, one shows the
absorbance read per each cycle and the last one, on the lower part of the page, summarizes the
reaction information.
It is possible to print the graphs or export the data (see Chapter 3, par. 2.1 Printing interface).

When opening the graphs page, the analyzer will show the first available graph.
Use the left/right arrows to see the other reaction graphs of
the same patient.
Use the up/down arrows to select the preceding or the
following sample.
It is also possible to click on the Code line to choose one of
the available sample codes and view its graphs.

Also the reagent blank graphs are reported in this pages. The reaction graph is the same as for the
test, but the Result line is not present. The number of blanks graphs present in these pages
depends on the way the analysis blank was programmed in the parameters.

Figure 8-5

The reaction graphs are divided into parts by dashed red axes, each of which indicates an
absorbance value used in the result calculation (in the reaction formula set in the parameters). The
above example is a fixed time test. In this case the result is calculated by means of an absorbance
delta, which is determined between the two cycles (17th and 6th) corresponding to the red dashed
lines. Between the two red dashed lines the analyzer calculates a regression line using the first and
last absorbance point. The regression line is indicated by a green line and is drawn for every test,
including blanks, for which there are at least two points between which it is possible to calculate the
regression line.
The X axe indicates the cycles (time) and the Y axe indicates the absorbance.
The single absorbance per cycle is indicated in the two columns at the right of the graph.

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Figure 8-6

In the Statistic area, there are the most important information concerning the reaction. This area is
divided in two parts. The left part lists the absorbances in relation to the whole reaction, while the
right part refers only to the absorbances used in the result calculation.
The last lines in this area give the final reaction result, i.e. the Value, the absorbance calculated with
the reaction formula mAbs (upon which the result is calculated) and the reagent Blank value.

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1.4. Flags list

The analyzer uses flag symbols to properly check analyses result. These symbols are printed
adjacent to the result.
The following priority exists for the flags indicating hyperactivity:
I (Test Limit),
A (Reaction Limit)
d (Max ABS Delta)
The flags and their meanings are tabulated below:

O Reagent Limit
! Final Abs Sign
F Form (and Tolerance)
I Test Limit
d Max Abs Delta
A Final Abs
i Sample Interference
H Hook
+ Path High - Range Normal Values >Max
- Path Low- Range Normal Values <Min
> Out Of Calibration Curve – Above
< Out Of Calibration Curve – Below
>> Out Of Calibration Curve After Repetition - Above
<< Out Of Calibration Curve After Repetition - Below
K Test performed with backup reagent
S No Sample
R No Reagent
-- Negative Concentration
P No Data To Calculate – data are not enough
E Sample Recalculated
d No Diluent (saline, diluent, etc)
N Reagent Expired
M Error In Instrumental Fact/Shift
Z Impossible to aspirate the sample
z Problem during the dispensing of the sample
RELATION TESTS
? Relation test - Not Calculable – one or more of the built-in analyses is missing
* Relation Test - Error In Built-In Analyses – there are error flags
X Relation test - Result Impossible – negative value
I.S.E.
Y I.S.E. Hydraulic Malfunctioning – funnel does not empty
B Bubbles In I.S.E.
D Drift On I.S.E.
Concentration Too High (calculated concentration is 20 times higher of the high standard
++
concentration)
s No I.S.E. Sample Diluent
e No Reference (I.S.E.)
t Calibration probably not accurate

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CHAPTER 9
SETUP
ANALYZER SETUP
The analyzer setup is used to customize certain aspects of the analyzer program, such as the report
format.
To open the Setup, click on the Utility main menu and select the command Setup.
The Setup window is divided in two parts. On the left there are the two main menus, System and
Patients which can be alternatively selected. On the right there is a window where all the details
dedicated to each setting are available.

1. SYSTEM

In this menu are available all of those settings generally applied to the whole
system.

Figure 9-1

1.1. Language
In this window it is possible to select the desired language
among those available. To select a language it is first
necessary to have saved the external translations.
The external translations are text files that can be easily
translated in other languages, therefore it is virtually possible to
translate the analyzer software in every language. The only
limitation is that the computer Operative System should
support the same language. The available languages are
loaded during the software installation: just select the desired
one. If it is necessary to load new translations, click on the
button Load external translations. Select the folder where
these translations are stored and click OK. The available translations will be visible in the list Stored
Translations. Double click on the desired language and save the Setup.

1.2. Printer
The Printer page can be used to customize the analyzer
reports with the name and address of the Lab and the name of
the Lab responsible. There are two areas where it is possible
to add the text: the header and the footer. The text character
can be formatted as desired.

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1.3. Access Passwords

This windows allows the operator to change the
system passwords. Bear in mind that, once
changed, the passwords must be stored in a safe
place. In any case, it is not advisable to change
these passwords, since if they are forgotten or lost
it will no longer be possible to access the system.

1.4. Bar-code
This option enables the bar-code scanning. It can be
separately enable on samples or on reagents or on both.
The bar-code on reagents can simply be enabled or
disabled, with no further settings.

1.4.1. Bar-code on samples

The bar-code can start with the patient ID as well as with another type of information. Therefore it is
necessary to tell the analyzer from which position the information starts.
Patient ID#: enter here the information concerning the patient ID#. In the N. Digits field, type the
length of the patient ID#, i.e. how many digits it will be from 1 to max 20. In the Digit position field
enter the position to start from, among those composing the bar-code (see below the example).
In the Supplementary information it is possible to activate/deactivate the use of one or more digits
to identify the sample type or to assign a profile number.
Sample type: the analyzer allows four type of samples: each has a single digit to identify it.
0 for serum
1 for urine
2 for CSF
3 for Other
When this field is active, it is also necessary to indicate which, among the bar-code digits, gives this
information.
Profile: the profile number can be identified by 1,2 or max 3 digits. Select the N. Digits and then
type the position, within the bar-code, where the profile code starts from.
Here are some examples.
Example number 1: 20 digits bar-code.
1 2 0 9 8 7 6 5 4 0 1 0 0 1 3 0 2 0 1 2
Lab code Patient ID# sample profile date
The bar-code starts with the Lab code: 120
The Patient ID# is made: N. digits = 6 and the Digit position = 4.
The Sample type is Active and the sample is serum, therefore the Sample type = 0 and the Digit
position = 10.
The Profile is active and the profile code is made of two digits, therefore: N. digits = 2 and the Digit
position = 11.
The date expressed as mmddyyyy uses the last 8 digits of the code.

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Example number 2: 30 digits bar-code.

1 2 6 5 1 1 2 3 4 5 6 7 8 9 0 1 2 3 5 2 1
Lab code Patient ID Profile Other info
The bar-code starts with the Lab code: 1265
The Sample type is Active and the sample is urine, therefore the Sample type = 1 and the Digit
position = 5.
The Patient ID# is made: N. digits = 13 and the Digit position = 6.
The Profile is active and the profile code is made of three digits, therefore: N. digits = 3 and the Digit
position = 19.
The last digits are available for other information.

ENTERING PATIENTS
Tests to be run can be acquired from the Host Computer, from those stored after manual input and
through barcode scanning (see chapt 5, par. 4.2.1, 4.3 and 4.4).
Manual programming: the patient is programmed manually (code and analyses), then his position
on the sample tray is checked by barcode reading. In this case the samples can be inserted
randomly on the tray, since the barcode reader will assign the position on the tray to the patient
corresponding to each code read which has the same ID code.
Programming via Host Computer: The patient is programmed (code and analyses) on the Host
Computer and transferred to the analyzer. The position on the sample tray is checked by barcode
reading as described above.
Entering patients with and without bar-code on the same tray
Patients with barcode and those without can be run together. Patients without barcode must be
inserted exactly into the positions assigned during programming. Patients with bar-code can be
freely placed in any of the free position with no need to respect the assigned position number.
In case a bar-coded sample is found in the same position where a manually programmed patient is
stored, the analyzer will move the manually programmed patient to the Extra list.

NOTE: two identical barcodes are read in two different positions. In this case the analyzer will
save only the last read code and will delete the previous one.

Supported Symbologies
- Barcode (1D): JAN/UPC/EAN incl. add on, Codabar/ NW-7, Code 11, Code 39, Code 93, Code
128, GS1-128 (EAN-128), GS1 DataBar (RSS), IATA, Industrial
- 2of5, Interleaved 2of5, ISBN-ISMN-ISSN, Matrix 2of5, MSI/Plessey, S-Code, Telepen, Tri-Optic,
UK/Plessey
- Postal code: Chinese Post, Korean Postal Authority code
- 2D code: Composite codes, MicroPDF417, PDF417
EAN13
If the bar-code used is an EAN13, there are some limitations: the first number must not be 0 and the
actual number of digits is 12 as the last digit is the checksum X (automatically created).

1.4.2. Bar-code on reagents

The main objective of the reagent bottle barcode is the positive identification of the bottle to avoid
positioning errors. The barcode can be used only with specific labels produced by the manufacturer
of the reagents.
The instrument can be configured in the following different modes of operation
Use of reagent bottles without barcode, independent use.
Use of reagent bottles with barcode (analysis code), only for positive identification of the bottle.

NOTE: when the analyzer reads the same bar-code on different positions, it will consider these as
duplicates, i.e. as backup reagents.

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1.5. I.S.E. Module

This function is available only with the 3rd level password.
The I.S.E. Module can be enabled or disabled by means of the checkbox.

1.6. Temperature
There are three devices that are temperature-controlled. The cuvettes, the samples tray and the
reagents trays. All the three devices can be separately enabled or disabled.
Cuvettes tray: the cuvettes are kept at a temperature of 37°C. The heating of
the cuvettes can be disabled if necessary. For instance when the room
temperature is higher than the cuvettes temperature. It makes no sense to
have the system heating the cuvettes at 37°C when the room temperature is
at 40°C.
Reagents tray: the reagents are normally stored at controlled temperatures.
To ensure a longer life to the reagents on board is useful to have the
reagents chamber at a relatively low temperature. The choice of the
temperature depends on many factors: the room temperature, the time the
reagents will remain on board, etc… The lower the temperature is set, the more will be the analyzer
effort to keep it down. If the reagents will last only a few days on board, there is no need to keep the
temperature too low. Samples, standards and controls are located in the reagents tray, so they will
be at the same temperature.

1.7. Clot Sensors

The clot sensors page includes the clot sensors themselves and their sensitivity.
Clot Control: this check will allow the analyzer to verify the presence of an obstruction (in aspirating
or dispensing) in the samples arm needle. The Sensitivity can be used to better adjust the Control
clot. Increasing the value, the sensitivity will increase and vice-versa when decreasing.
When the analyzer detects a problem in aspirating, the sample is aborted and flagged with "Z".
When the analyzer detects a problem in dispensing, the sampling goes ahead and the sample is
flagged with "z".
The default value for the sensitivity is 10.

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1.8. Administrator
The Administrator has the possibility to use or not the reagents Lots' control. When this option is
disabled, the analyzer will not perform any control on the reagents lot or expiry date. On the other
side, when this option is enabled, it is possible to enable also the following checks.
Check dates: this check will allow the analyzer to warn the user when
a reagent has reached its expiry date. An expired reagent will be
automatically removed from the reagents tray and will not be useable
anymore. In the Reagents Lot Management are listed all the
analyses with the Expiry date.

1.9. General Options

In this page it is possible to set the number of remaining samples that will activate the reagent
volume limit alarm.

2. Patients
In this menu are available those settings applied generally to the
patients and patients results.

Figure 9-2

2.1. Samples' Groups

In the analyses parameters, as well as in the patients entry, there is a
field dedicated to the Group. In the analyses analytical parameters it
is necessary to define the values normal range for each group, while
in the patients entry it is necessary to select the group for every
patient in order to correctly refer each result to its normal range.
The analyzer provides automatically the three basic groups: Male,
Female, Children. Beside these, the user can define other 15 groups.
Simply click on the group and type the new definition for it.
For certain analyses it may be useful to have a specific group and
specific normal values range, for instance, for newborns.
In this case the group can be defined as Baby<1.
The same applies to groups under specific therapies e.g. Male therapy xxx or to limited populations
with normal values different from the rest of the population, such as people living in high mountains,
whose diet is different from people living by the coasts.

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2.2. Communication
The Communication page allows to set the
parameters for the communication between the
analyzer and a host computer.
Once the communication is activated, all the
parameters will be displayed. These parameters are
different for the two type of Transport. This can be
Serial or TCP/IP.
NOTE: when changing from TCP/IP to Serial or vice-
versa, or when changing the TCP/IP port number, it is
advisable to turn the PC and the analyzer OFF and
ON again to avoid possible problems with the OS.
Selecting TCP/IP it will be necessary to select the
Port.
The default communication port is 8888. It can be set
by the technical assistance personnel with their password. If the communication port is changed, it
will be necessary to turn the external PC off and then on to activate the new port.
The TCP/IP protocol version used is version 4 (not version 6).
Then set the other parameters as explained below.
Selecting Serial, the appropriate parameters will be displayed. The default parameters are listed
below. If necessary, seek the advice of the technical personnel who has interfaced the analyzer.

COM Port: select the appropriate communication port. (for example COM 1, COM 2 etc.)
Baud-Rate: Sets data transmission speed between the analyzer and the host
computer. Click  to view all the possible transmission speeds. To select,
click on the desired value.
Parity: None
Word Length: 8
Stop Bits: 1
Hand-Shake: Enables Data Flow Control to be used during data
transmission. Click  to view the available options. To select, click on the
desired option.

Protocol: it is possible to use the ASTM protocol or a variable protocol. When choosing the variable
protocol, it will be possible to set the protocol options by clicking on the
dedicated button Modify Scripts. Only expert operators should set the
variable protocol.

ONLY WITH ASTM PROTOCOL. In case the analyzer, after having read the bar-code on the tray,
does not find in its programmed work-lists the patient corresponding to that code, it will require this
information to the host computer.
Use Query Mode: the Query Mode allows two functions:
- to send to the Host computer the patient data and related analyses
when an unknown patient bar-code is read
- to send to the Host computer a message containing the sending
patients outcome, which may be positive or can contain errors.
The Disable auto answer mode option is to disable the sending of the message with the patients
outcome.

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Only one header/terminator frame: in the ASTM protocol, in case of a package of more than 240
characters, it is possible to divide it in sub-messages each with its header/terminator, or it is
possible to send the header for the first message and the terminator for the last one.
If the option Only one header/terminator frame is disabled, the Header and Terminator frames will
be present for each single sub-message. Otherwise (Only one header/terminator frame enabled)
the Header will be present only for the first message and the Terminator only for the last one. See
also the Communication, chapter 16, par. 1.2.

These options concern the real time results

Send results without validation: when this option is enabled,
all results from the analyzer are sent automatically and
immediately to the communication buffer (it will be then the host
computer to require the data). If the option is not enabled, then
the operator will decide when to send the data.
Send partial results: with this option it is possible to send to the communication buffer also the
partially performed patients. This may happen when some patients have been programmed with
tests that are on the tray and tests that are not. After the first run, it is possible to put the remaining
tests on the tray and run again the patient. In this case, the communication buffer will receive twice
the same patient. It will be the host computer to eventually merge it.
Send results without value: by selecting this option the non-calculable results will also be sent to
the communication buffer, if the option is not enabled the <NC> results will not be sent . In this case
the <NC> results can be run again and if there are valid results, they will then be sent to the
communication buffer.

These options concern the patients sent via host computer

Send on supplementary list: when the check is enabled, the
analyzer will load the patients sent via host computer in the
supplementary list, in order to place them in the work-list only
upon receiving the sample. It is possible to decide between two
options. Only if not empty: the analyzer will send the patients to
the supplementary list only if this one is not empty. In all cases: the patients will always be sent to
the supplementary list.

NOTE: if the communication port is changed, it is always better to switch the PC OFF and ON again
to ensure the modification has been correctly saved.

2.3. Sort Results

This window allows the operator to select the way to arrange the results in the real time results
page. Select the desired combination of options and save. To let the analyzer sort the results in the
real time Results page, click on the Sort button.
It is possible select the sorting criteria for Patients, Analyses, I.S.E. results and Relation tests
results.
Selecting NONE for all options, the analyses will not be sorted, but will be listed as they arrive to the
Real Time pages.

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PATIENTS
BY CODE: sorting is done by alphanumerical order of the ID code. The alphanumerical order means
that codes can be ordered as follows: CODE1, CODE10, CODE2, or as follows, depending on the
way numbers are written, CODE01, CODE02 AND CODE10
BY POSITION: patients are ordered by their position on the tray. In case of patients programmed in
the same position, the analyzer will insert them in the new order as it finds them in the Result page.
BY TIME: patients are ordered upon the execution date and time. Within every date, patients are
ordered by time.

ANALYSES
Within every patient, analyses can be sorted with their own criteria.
BY CODE: analyses are sorted by the alphanumerical order of the code. If codes are all
alphabetical, the codes will be ordered in alphabetical order, but if there are alphanumerical codes,
these will be ordered as for patients.
BY POSITION: analyses are ordered upon their position on the tray.
BY TIME: analyses are ordered upon the execution time.
SPECIAL ANALYSES: I.S.E. & Relation tests
Both I.S.E. and Relation tests can be ordered specifically. If set to NONE, the tests will be inserted
in the list in the order as the analyzer finds them in the Result page.
AT TOP: the special tests will be placed in the new order at the beginning of the list.
AT BOTTOM: the special tests will be placed in the new order at the end of the list.

2.4. Diluents Identification

The analyzer has three available positions for the use of diluents
dedicated to the samples. These positions allow 30ml bottles
that may contain any necessary solution. By default these
bottles are named as follows:
#1 saline solution
#2 diluent
#3 samples treatment
Next to the sample teatment there is the Time for special
preparation button: type here the time (from 3 to 10 minutes)
that the sample will incubate with the treatment solution before being sampled.
The special preparation is done in the samples’ tray inner ring. If it is activated during a run, the
sample dispensing phases will be suspended until the preparation incubation time is elapsed.
As far as every Lab may have or use special solutions for different needs, these three bottles’
definitions have been left "open", to let the operator name them as necessary.
To assign a definition, simply click on the editable field and type the solution's name.

ATTENTION: remember that the saline solution is often automatically used by the analyzer (zero
point in calibration curves, external dilution, etc).

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CHAPTER 10
TECHNICAL FUNCTIONS
TECHNICAL FUNCTIONS
In this chapter are first explained the analyzer utilities, the mechanical calibrations and then the
available diagnostic functions.
In the normal routine use, there are only a few adjustments that may become necessary. On the
other side, there are many utility functions that are commonly used. The diagnostic pages are
normally reserved to the technical assistance personnel.

1. ANALYZER UTILITIES
The analyzer utilities can be accessed by the main menu Analyzer or from the side bar, under the
option Special Functions. Refer to the Used solutions/detergents for any information concerning
the solutions/detergents to be used and the Ordering information.

Figure 10-1

To activate any of the following commands click on the corresponding button.

Wash cuvettes: is used for complete washing of the hydraulic circuit and reading cuvettes with the
system solution. At the end of the procedure, cuvettes are left dry.
Wash and fill up cuvettes: washes, with the system solution from the external tank, the cuvettes
and leaves them filled with system solution. This function is recommended when a work session has
ended and the analyzer is not going to be used again immediately.
If the analyzer is left idle it will wash and fill up the cuvettes (see Automatic procedures), then a
screen-saver will appear. Press any key or click with the mouse to exit from the screen-saver mode.
The analyzer will ask again for the user log-on.
Daily wash cuvettes: is used for complete washing of the needles and reading cuvettes. Once the
command is given, a guiding message appears asking to insert the bottle (50ml bottle) containing
the dedicated solution in the indicated position. The analyzer will wash the cuvettes with system
solution, then will fill them with the proper solution (from the reagents tray) and will leave the
solution in the cuvettes. This function must be used at the end of the day if the analyzer is not
turned off. The shut-down procedure (guided washing function at the shut-down) uses the same
washing procedure already explained.
Extra wash cuvettes: is used for complete washing of the needles and reading cuvettes with two
dedicated solutions: one basic and one acid. Once the command is given, a guided procedure
appears asking to insert the bottles in the indicated positions (50ml bottles). The analyzer will wash
the cuvettes with system solution, then will fill them with the proper solutions (from the reagents tray,
acid solution first, followed by a wash cycle with system solution and then basic solution). At the end
the analyzer will fill the cuvettes with system solution and will leave it in the cuvettes.

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This wash is necessary at least once a week or if the analyzer returns inconsistent results for no
apparent reason. This wash will reset the Diagnostic page maintenance counter.
Needles prime: performs a filling-up cycle with system solution of the hydraulic circuit and sampling
system.
Prime I.S.E.: starts the I.S.E. prime. See chapter I.S.E.
Wash I.S.E.: This function activates the washing of the I.S.E. module. For more details, See chapter
I.S.E.
Zeroing on water: Performs photometer zeroing with system solution. It is important to remember
that zeroing is necessary to avoid any drift of the photometer zero and has to be performed after the
analyzer has reached the steady state (approx 30 minutes after turning on).
If one cuvette is out by 15% (identified in bold red), there will be an error in the zeroing, but likely
there is no serious problem. If a cuvette is out by 40%, there is a serious problem (the cuvette is
empty and possibly broken). If all cuvettes are out by 15%, there may be a dispensation problem.
A cuvette out by 40% or all out by 15%, will cause a block of the analyzer.
F.C.C. calculation: This procedure is for calculating the optical correction factor for the reading
cuvettes. A screen message invites to insert a bottle with appropriate solution (supplied by
Biotecnica – ask to the Technical Assistance Service) into the reagents tray. Generally a solution
with absorbance in the range between 0.500 and 1.000 Abs (read at 340/700nm) is used. The
analyzer guides the user through the procedure. This function is password protected.
It is performed only when one or more cuvettes are replaced or after a thorough service is
performed on the instrument computer (e.g. hard disk substitution) where correction factors may be
lost.
Lamp Setup: this function is only necessary after the photometric lamp has been changed. It is
used to align the new lamp to preset internal values. It also carries out photometer zeroing at the
same time. It is advisable that only technical assistance personnel use this function.
Washing station prime: with this function the analyzer performs a fill-up of the washing station
hydraulic circuit.
Enzymatic wash: See chapter I.S.E..
Empty Fluidics: This command completely empties the fluidic circuit. It is to be used exclusively as
preliminary operation for maintenance or eventual moving of the instrument.
Safe removal of the I.S.E. rack: See chapter I.S.E.
I.S.E. Long Term Empty: See chapter I.S.E..

2. MECHANICAL CALIBRATIONS
This function allows mechanical centering and adjustments for the different positions of the
sampling arm, cuvettes plate, sample and reagents tray. Bear in mind that the analyzers are already
factory-calibrated and a new adjustment is seldom necessary.
The mechanical calibrations are divided into two
main sections: Arms and Trays
Each section, once opened gives access to the
specific and dedicated functions.
To perform calibrations, click on the desired
function: the Left and Right command keys will be
enabled on the screen, which determine the
movement of the selected object either clockwise or
counterclockwise, step by step. The [!] Test key
lowers and lifts the sampling needle or the wash
piston to check centering.
Figure 10-2

NOTE:
It is highly recommended to calibrate the trays first and then the positions of sampling arm.

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ARMS
There are two sampling arms. One for the reagents and one dedicated to the samples. Each arm
must be calibrated in all positions. Click on the line corresponding to each position, then use the
arrow buttons to adjust the needle, which has to be centered above the selected position. To test
the centering, use the Test button. The Height adjustment is normally performed in factory. Please
read carefully the dedicated paragraph before using this function.

Arm on sample
The sampling arm must be centered on the
wash position, on the two samples positions
rings, on the I.S.E. positions, on the
cuvettes and on the diluent bottles.

Arm on reagent
The arm must be centered on the washing
position, the reagent bottles and on the
cuvettes. The arm must be centered on the
neck of the large and small bottles.

Samples tray
Click on every arm position: the needle will
move to that position to allow the tray
adjustment.
The samples tray must be adjusted in order
to have the needle centered on the two
samples rings. Then it has to be set the
position of the tray respect to the bar-code
readers and the insert positions (see
pictures below). The Bar-code: samples
position has to be calibrated by the technical
assistance.

Insert position: calibrate the position for the

manual inserting of the samples/standards.
The pointing arrow indicates the position
where the indication is placed.

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Click on the reagent positions: the needle
Reagents tray will move above that position to allow the
tray adjustment. It has also to be centered
to the reagent insertion position and on the
bar-code reader position.
Insert sector: see below picture, ref. #1
Insert position: see below picture, ref. #2
Insert reagents: see below picture, ref. #3

Ref. #1: center the reagents sector in the

opening that allows the insertion/removal of
the sector.
Ref. #2: center the single reagent bottle on
the opening in the samples tray, placed in
front of it (samples gap)
Ref. #3: center the samples gap in the
center of the opening of the chassis. In the
left picture the samples gap is not centered,
while it is centered in the right picture.

Cuvettes
The cuvettes tray is adjusted when the
washing station descends straight and
correctly into the cuvettes.

HEIGHT ADJUSTMENT: this button is used to memorize the maximum descent of the needle in the
selected position. For the reagents positions, including the I.S.E. sampling diluent, an empty bottle
must be in place. For samples positions a primary tube and a cup (for the dilution positions) must be
in place. The needle will go fully down until the crash sensor is activated. In this way the analyzer
memorizes the maximum possible descent in every position.

RESET CALIBRATIONS AND RESET HEIGHT ADJUSTMENT: these buttons are used to reset
the mechanical positions calibration for the arms and to reset the maximum descent of the needle in
the selected position.

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3. DIAGNOSTICS
Diagnostic pages are accessible from Analyzer’s main menu. The
Diagnostic functions are partially reserved for approved service personnel
only. Therefore the access to some of the functions is password protected.
It contains the following options: View F.C.C., View Optical Transmission,
maintenance and General Diagnostics.

View F.C.C.: It shows the optical correction factor calculated for all the reading cuvettes. For each
cuvette, the mABS and the F.C.C. values are
reported. It also indicates the cuvettes with
correction factor exceeding the preset limits
(± 3%). It is possible to print this page.

View Optical Transmission: After each photometric zeroing, it indicates the

percentage transparency of the cuvettes. The cuvettes with poor
transparency are highlighted. If the optical transmission of a cuvette falls
below a specific percentage (40% less than the mean of the calculated O.T.),
the analyzer will highlight it in red it and will go on working. If it becomes
necessary to eliminate four or more cuvettes, the analyzer generates an
alarm and will not allow work to continue. It is possible to continue to work
with three damaged cuvettes.Optical transmission of the cuvettes tends to
decrease due to a series of factors, including lamp performance, opaque
cuvettes etc.

Maintenance: see the following paragraph.

General Diagnostic: This function is reserved for the Technical Assistance

personnel for diagnosing problems that cause analyzer malfunction. There is
no free access to this program: it is password protected.

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3.1. Maintenance
In the maintenance page there is the list of the parts of the system that require periodical
maintenance. Among these, there are the I.S.E. electrodes, the peristaltic pumps, the sampling
needles, the lamp, the hydraulic kits.

Clicking on the grey buttons on the left side of each line it is possible to see a picture of the item.
The Validity column indicates the life of the item, i.e. the time between two replacements.
The Expiry column indicated the calculated date for the replacement, starting from the moment the
item was replaced (see Reset).
The Reset button will reset the expiry date. After the item is replaced, click on this button to let the
analyzer recalculate the expiry date.

The only maintenance required to the user is the electrodes replacement (see I.S.E. chapt.). For the
rest of the maintenance, call your technical assistance service (see Maintenance and
troubleshooting).

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CHAPTER 11
I.S.E. MODULE – 2P - SOLID STATE

1. I.S.E. MODULE 2P
In addition to the Clinical Chemistry and Immune-chemistry tests, the BT analyzers allow tests for
the Na+, K+ and Cl- ions with ion selective electrodes (I.S.E. module) with indirect potentiometry
method.
The device consists of a reading module with a partially dedicated sampling arm and therefore can
be considered as a stand-alone module of the instrument.
The system is called Ion Selective as the electrodes used respond to their respective ions in
accordance with the Nernst equation:

E = E0 + RT/nF log aM+

aM+ = M+ ion activity
E = observed potential in Volts
E0 = constant (standard potential for a redox semi-reaction referred to hydrogen electrode)
R = gases’ constant
F = Faraday’s constant
T = temperature in Kelvin degrees
n = ion’s charge

It is highly recommended to carefully read this chapter before using the system. The user should
also keep in mind that all the ISE components must be maintained in optimal operating conditions to
ensure precise and accurate determination of results.
The correct use by the well-qualified personnel, assures quality test results as well as a longer
duration of the electrodes. Lifetime for electrodes is about 1 year for sodium and reference, 3
months for potassium and chloride.
However, the electrodes lifetime depends upon the number of samples determined, and the
observation of routine maintenance at proper intervals.
For a correct use of the system, the user must observe some
basic functions such as initial restoring for electrodes conditioning,
calibrations repeated every 4 hours or at any temperature
variation that is greater than 3°C and at the substitution of working
solutions (Buffer & Reference). When turning off the analyzer it is
necessary to perform a washing procedure with appropriate
detergent solutions.

This chapter gives some operating suggestions and GLP to help

assure precision and accuracy of the system.
The ISE module is located on the right side of the analyzer under
its cover. The ISE reagents are positioned near the ISE module.
The buffer is placed in its seat next the I.S.E. funnel and the
reference solution in an apposite lodging next to the I.S.E. panel.

Figure 11-1

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Schematic description of the I.S.E. Module.

1. Funnel – K electrode interconnection tube

2. Cl electrode – Ground electrode interconnection
tube
3. Reference electrode – distributor interconnection
tube
4. Distributor – funnel interconnection tube

Figure 11-2

1.1. Operating Principles

The I.S.E. Module-2P works with the indirect potentiometry method, which means a work method
where samples are diluted before the reading. With respect to the direct potentiometry, which
requires a large amount of sample, the indirect potentiometry can work with a minimum sample
volume. The sampling system provides the dilution of sample in the desired ratio using the sample
diluent solution.
The prediluted sample is then dispensed into the I.S.E. funnel (or bowl), from where it flows through
the electrodes and then through the ground electrode to the waste.
Each reading is alternated with a reference reading.
The bubble sensors indicate to the system when there are bubbles in the liquid path or there is no
more solution left.

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1.2. Applied Mathematical Functions

COMPUTING THE SLOPE

(mVh − BLh ) − (mVl − BLl )

Si =
 C + BSF 
Log  h 
 l
C + BSF 

where:
S : Slope
i : Electrodes
BSF : Base Line Factor
mVh : mV High Standard
mVl : mV Low Standard
BLh : Base Line High Standard
BLl : Base Line Low Standard
Ch : High Standard Concentration
Cl : Low Standard Concentration

COMPUTING THE RESULT

  
 ( mVi − BLi ) − ( mVsl − BLsl ) 

 
Conc = Csl + BSF ⋅10 − BSF
Si
 
 

where:
S : Slope
i : Electrode
BSF : Base Line Factor
mVi : mV Electrode
mVsl : mV Low Standard
BLi : Base Line Electrode
Blsl : Base Line Low Standard
Csh : Low Standard Concentration

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1.3. Precautions For I.S.E. Module-2P Usage

CAUTIONS
1. Before operating this system, be sure to read the operator manual thoroughly and carefully.
Afterwards, keep it handy for future reference
2. Use only original Manufacturer’s products (reagents, washing solutions, maintenance kits,
etc…).
3. Never remove the electrodes while the analyzer is working. This may cause malfunctioning
of the system.
4. The ambient conditions play an important role in the correct use of the I.S.E. Module. Room
temperature must be between 20°C and 26°C, and the humidity between 35% and 75%.
5. If the room temperature varies (even by 2°C or 3°C) during a working day, then it will be
necessary to repeat the calibration of the I.S.E. Module just before running tests to avoid
errors during next readings.
6. It is suggested to insert the solutions (at room temperature) at least 30 minutes before
operating phases begin. If the thermal equilibrium is not reached, then the phenomenon of
drift and erroneous results may occur.
NOTE:
I.S.E. Module should be calibrated only after the above-mentioned equilibrium has been
reached.
7. It is recommended to run the standardization twice a day, in the morning and in the
afternoon or in any case every four hours. Standards and samples should be at room
temperature before they can be used.
8. When using the chemical standards, bear in mind that they are altered by air exposition.
Therefore, it is recommended to fill the cups ¾ full (to minimize evaporation effect) and run
the calibration immediately afterwards and then discard the remaining standard. In any case,
do not leave standards exposed to air for longer than 15 minutes.
9. Bear in mind that the samples are altered if exposed to air for more than 30 minutes.
10. The buffer bottle must always be closed (in case only a few samples per day are performed)
after the ISE determinations.
11. If the working solutions are replaced, then the calibration should be performed again to avoid
possible incorrect results.
12. If the electrodes are removed for any reason, then carefully note down the electrodes
sequence positions. The potassium electrode (K) must be immediately detached (by
disconnecting the tube) from the next electrode (Na) in the stack and maintained in vertical
position, because even a small reflux of liquid from other electrodes can destroy it.
13. The electrodes should be washed every day. This makes the electrodes more stable and
guarantees a longer life.
14. If only a few samples are run during the day, all the bottles containing I.S.E. solution should
be closed and stored as directed in the single reagent instructions (insert), in order to
minimize contamination and evaporation.

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2. PERFORMANCE AND LIMITS - I.S.E. MODULE-2P

Method: Indirect potentiometry
Number of electrodes: 3 plus Reference Electrode
Analytes: K+, Na+, Cl-, (By-Pass)
Analytical throughput: up to 225 tests/h (K+, Na+, Cl-)
Reagents: Buffer (concentrated) and Reference Solution
Sample Type: Serum, Urine (whole)
Sample Volume: 21µl
Concentrated Reagents Dilution: 1/10 with H2O (automatically)
Dilution of Serum/ Buffer: 1/14 (automatically)

Precision
Serum Urine
K ± 1 % ± 2 %
Na ± 1 % ± 2 %
Cl ± 2 % ± 2 %

Linearity
Serum Urine
K 1 - 20 mEq/l 2 - 200 mEq/l
Na 50 - 200 mEq/l 20 - 400 mEq/l
Cl 50 - 400 mEq/l 40 - 400 mEq/l

Accuracy
Intra-run (C.V.) Inter-run (C.V.)
Serum Urine Serum Urine
K < 1 % < 2 % < 2 % < 2.5 %
Na < 1 % < 2 % < 2 % < 2.5 %
Cl < 2 % < 2 % < 2.5 % < 2.5 %

SOLUTION VOLUMES (approx)

SAMPLE/STANDARD : 21µL
WATER (system solution): 245.7 µL
BUFFER: 27.3µL
WATER (system solution) + BUFFER: 273µL
REFERENCE: 320µl

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3. GENERAL INFORMATION ON THE I.S.E. MODULE-2P

I.S.E. PRIME
The I.S.E. prime is necessary to ensure that the hydraulic circuit is full, that there are no bubbles
and it is also necessary to calibrate the bubble electrodes.

CALIBRATION
It is necessary to calculate the slopes upon which the analyzer will then calculate the samples
results. The calibration requires two standards that have to be placed in the tray’s standard
positions.

SAMPLE ANALYSIS
The determination of a sample is always followed up by a reading phase of reference solution. The
sample is dispensed into the funnel by the sampling arm: it picks up the water (system solution) +
the sample diluent + the sample and dispenses into the funnel (mixing chamber) for successive
mixing.

WASHING
The washing of the electrodes is necessary to ensure the good performances of the I.S.E. system.
There are two type of washings: the enzyme wash and the I.S.E. wash.
Both washing solutions must be placed in cups in the inner ring of the samples tray.
The enzyme wash is necessary to remove the possible protein clots that form inside the very small
tubes inside the electrodes, especially the Cl electrode. It must be performed weekly.
When running many I.S.E. samples (more than 20-30 samples), it is advisable to run it daily.
The I.S.E. wash is used to daily wash the whole I.S.E. system and keep the electrodes conditioned.

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4. ANALYZER UTILITIES & OTHER I.S.E. FUNCTIONS

4.1. Analyzer Utilities

Some of the analyzer utilities (see chapter 10, par. 1.) are dedicated to the I.S.E. module

Figure 11-3

Prime I.S.E.: starts the I.S.E. prime. An I.S.E. prime is necessary every time the system has been
left unused for a few days, after any I.S.E. maintenance, after having replaced the reagents, every
time there are bubbles in the I.S.E. hydraulic path.
I.S.E. Wash: This function activates the washing of the I.S.E. module, which has to be performed
daily when using the I.S.E. module. In case the analyzer is never switched off, this procedure must
be activated by means of this command, otherwise, the procedure will be automatically required
when turning the analyzer off or when activating the Suspend Activity mode. In this procedure it is
necessary to put a cup with the I.S.E. washing solution in the tray. The analyzer will display a
message for guiding the operator.
I.S.E. Enzymatic wash: this procedure is normally necessary only once a week. The analyzer will
guide the operator with proper messages on the display. The two washing solutions will have to be
placed in cups in the tray. The enzymatic solution is especially necessary to remove the protein
clots that may form in the Cl electrode when performing a large number of tests.
Safe removal of the I.S.E. rack: with this option it is possible to empty the I.S.E. fluidic path to
safely remove the electrodes without liquid spillage.

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5. PROGRAMMING THE I.S.E.

The I.S.E. module must be operated as every other chemistry test.
The ready-to-use reference solution is placed at the right side of the I.S.E. module. The
concentrated buffer is placed in its dedicated seat near the I.S.E. bowl and the other solutions are
placed, when necessary, in cups in the standard tray.

5.1. PARAMETERS
As all other analyses, the I.S.E. test can be found in the Analyses Management page.
In the General page, there are the general parameters for all the samples type.

Figure 11-4

Sample quantity: enter in this space the volume for the sample, expressed in µl.
Dilution - Sample: enter here the sample dilution ratio. The sample will be diluted with the
dedicated Sample diluent solution (in a 10ml bottle next the I.S.E. funnel).
Dilution – Reagent: enter here the reagent dilution ratio, the analyzer will use the system solution.
Incubation time: enter the incubation time expressed in seconds.
Reading time: as for the incubation time, enter the reading time in seconds.
Wash solution: enter the volume of the solution used for the wash between samples. The analyzer
will use the reference solution. The solution volume should be at least the same volume of the
dispensed sample. If the sample is 90µl, diluted 1:2, the dispensed volume will be 180µl and the
wash volume should be minimum the same.
Electrodes in use: select the electrodes for which the analyzer will return the results. When an
electrodes is not used or is expired, it is necessary to deselect it to prevent continuous errors during
calibration (until it is replaced).
Decimals: select the number of desired decimals or leave the automatic check: the analyzer will
use the floating point algorithm.
Enter all necessary parameters for serum and urine, then go to the Supplementary page.

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Figure 11-5

Limits: as for the clinical chemistry, enter for each Group, the Normal values and the Panic
values. This must be done for every electrode, selecting each with the corresponding tag on the
side of the page.
Enter the necessary parameters for all the sample types (serum, urine, etc).
Select the Pathological repetition if you want the values outside the panic range to be
automatically repeated.
Units: enter here the Primary unit and, if necessary, the Conversion factor from the standard unit
in case the primary unit is different. If desired, enter also a Secondary unit and its conversion
Factor from the primary unit.
Instrumental factor: introduces a correction of the final datum of the executed test; it can be used
to adjust the data of the test with different types or analytical methods or instruments. Calculation:
final result = value x instrumental factor.
Shift: the function introduces a quantitative correction of the final datum of the executed test; it can
be used to adjust the data of the test with different types or analytical methods or instruments.
Calculation: final result = value + shift.

The following are the suggested parameters - Table 1

Serum
Sample volume µl 21
Sample dilution 1: 14
Reagent dilution 1: 9
Incubation time 4
Reading time 4
Wash quantity 150

At the end of programming press the Save button.

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5.2. PROGRAMMING STANDARDS AND CONTROLS

Figure 11-6

For the I.S.E. calibration, two known standards are required. These standard have to be placed in
the standard positions of the samples tray.
In the analytical parameters (General standard) page it is only necessary to enter the standard
concentrations for each electrode.
The standard values are usually always the same, but every time the lot is changed, verify the new
values and correct if necessary.
The Slope range is set by Biotecnica for all electrodes.
The calculated Slope is updated automatically at the end of a positive calibration.
To assign the positions on the tray’s standard positions, go to the Manage Standard page:
Select the physical position on the tray’s standard positions for the two standard and enable the
calibration selecting the checkbox, as done also for the chemistry tests.

The following are the usual values for the standards and the slopes.
K Na Cl
Std Low 3.10 94 78
Std High 10.2 162 126

Slope min 40 50 -70

Slope max 70 80 -18

CONTROLS
For what concerns Controls, these are programmed exactly as the chemistries.

Figure 11-7

Select the electrode with the proper tag and enter all necessary information.

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6. REPLACING AND INSTALLING ELECTRODES

The analyzer is shipped with the I.S.E. module already in place. Electrodes and reagents must be
placed before starting the analyzer.
To replace or install the electrodes the analyzer must be turned off and then the following steps
must be observed. Make sure all not necessary items are removed from inside the I.S.E. Module
(protective labels or other items).

WARNING
Do not touch with bare hands the metallic pins of the electrodes, or the electrodes electronics, in
order to avoid electrostatic discharges that may cause system malfunctioning for several hours.

Figure 11-8

1. Detach all tubes from the electrodes

2. Release the screws that fix the electrodes’ supports
3. Slide the left electrodes support to remove it from the panel and immediately detach the K
electrode. Remove also the right electrodes support to replace the REF or the Ground
electrodes.
4. Install or remove and replace the electrodes as necessary.
5. Pay attention to the correct order of the electrodes, connect each other by means of the
small interconnection tubes and place them back on the support.
6. Slide the supports back in place carefully, inserting gently each contact pin in its electrode.
7. Fix the screws that secure the supports.
8. Once all maintenance is done, place back the hydraulic tubes
9. Perform one or more I.S.E. prime.
10. Perform an I.S.E. calibration.

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7. PRELIMINARY STEPS BEFORE STARTING THE SYSTEM

This procedure is necessary when installing the system or after replacing the electrodes. For
normal operating functions, observe the following procedure:
a) Place the working solutions in their respective lodgings
b) Make sure that the contents of the working solutions are sufficient for the necessary workload.
This verification of volumes is highly recommended. Whenever reference or buffer solutions are
changed, a new calibration of the system must be performed.
c) Run a Prime I.S.E. and repeat it for at least three times.
d) Verify that programmed values for the standards (high level/low level) correspond to the used lot.
e) To reduce the risk of contamination of reference and buffer solutions through ambient air, it is
suggested to remove and close the two bottles at the end of daily working sessions. Remember to
open and replace these bottles at the beginning of every new working session.

NOTES: if the device has just been installed, the electrodes have been replaced or if the I.S.E.
module has not been used for some time, various system primes should be run. Wait around 30
minutes before using the I.S.E. module to let the electrodes be conditioned by prior passage of the
reference solution.

The I.S.E. module should be considered by the user as an ordinary test for Clinical Chemistry
requiring a programming of its own for standards and controls. Calibration should be performed
every four hours and it is essential for precise and accurate results. In addition, it is recommended
to execute repeated calibrations until a stable slope value is obtained.

7.1. Calibration Procedure

Standards are automatically diluted with buffer solution with a ratio of 1:14. The mixed product is
aspirated into the electrodes through the peristaltic pump. After an incubation period, the reading is
performed.
At the end of calibration phase, the slope is calculated in accordance with Nernst equation:
Slope (s) = ΔE/(log STD high - log STD low)
where ΔE = difference in mV between STD high and STD low
After calibrating each electrode, optimal slopes are obtained which should be within the following
acceptance range:

Optimal slopes Range of slopes

K: 50 / 60 mV K 40 / 70 mV
Na: 55 / 65 mV Na 50 / 80 mV
Cl: -45 / -35 mV Cl -70 / -18 mV

In addition to the acquired slopes values, it is important to observe also the potential of the
standards in the calibration printout.
The potential values are related to standards, thus by changing standard’s lot with another
concentration, the different potentials will be observed with the same slope values.
In case the slope values are out of range, an on-screen error message is displayed, even if there is
an incorrect response from only one electrode. A check is also performed on the slopes
reproducibility. The values obtained during current calibration are compared to the values of
previous calibration. An error message appears during serum calibration if there is a variation
greater than 3% for K and Na, 5% for Cl

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After an incorrect calibration or in case of a calibration beyond the preset limits, the analyzer
automatically performs a new calibration, with up to 3 calibrations maximum.
If an I.S.E. sample is performed between the repetition of two calibrations, it will be flagged with the
"t" flag to indicate that the calibration is probably not accurate. The same "t" flag is given also if a
single electrode has given an "out of linearity" alarm during the last calibration, i.e., when the slope
is unstable.

NOTE:
If slopes and potentials are constantly out-of-range, this indicates that the electrodes are exhausted,
or there is an aspiration error of the reference solution in the reference electrode or the working
solutions are contaminated or degraded. In case of contamination or degradation, replace the
solutions and repeat the calibration procedure. In the other cases such as exhausted electrodes or a
reference aspiration error in the reference electrode, refer to the Troubleshooting guide.

7.2. Measuring Unknown Samples

After a correct calibration, the samples are determined, which are prepared and read in similar
manner to standards: aspiration into the electrodes, potential reading, and the reference aspiration.
The samples are calculated applying Nernst equation:
E - E0 = s log (Cx / C Std)
Considering the fact that the system requires a calibration, the measurement method is defined as
comparative.
I.S.E. tests are programmed in the same way as any other analysis of clinical chemistry.

Precision and accuracy errors when determining samples

Determined results can be associated to a flag that indicates eventual problems occurred during
measurement.
The presence of D flag near a result, relevant to one or more electrodes, indicates drift during
sample reading, i.e. the drift has exceeded ±2mV and thus the electrode may be unstable.
The flag R near the results indicates the absence of reagents.
The flag B adjacent to results indicates the presence of air (bubbles) in the hydraulic circuit during
the transfer of the sample into the electrodes.
The sign <NC> in place of the results, indicates abnormal values (for example 9999999,999) or
erroneous values (ex. No sample or reagent). Abnormal values may result from an interruption of
the liquid flow into the electrodes during the test reading phases.

8. MAINTENANCE AND TROUBLESHOOTING

8.1. Suggestions For Performance Maintenance.

To eliminate any problems during I.S.E. operation, observe the following suggestions.

Once a week perform a washing of the funnel. Simply use some gauze soaked with distilled
water to clean the funnel internally. Apply a little pressure with rotating movement.

Before a long period of system’s inactivity, proceed as follows:

a) Perform an Enzyme wash even if no I.S.E. determination has been performed.
b) Run an I.S.E. Prime.

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After a long period of system’s inactivity, perform the following:

Run a Prime I.S.E. and repeat this procedure for three times. Run a calibration. Repeat the
calibration until slopes are stable.

8.2. I.S.E. Maintenance

The I.S.E. maintenance involves the electrodes as well as the peristaltic pumps with their tubes.

ELECTRODES
The I.S.E. electrodes maintenance consists in the replacement of the electrodes as follows:
K: every 3 months
Na: every 12 months
Cl: every 3 months
Ref: every 12 months
If a large amount of tests are performed daily, it might be necessary to replace the electrodes more
often.
In the normal maintenance is also necessary to wash the electrodes daily and weekly with the
proper solutions.

For the electrodes maintenance, refer to par. 6 in this chapter.

PERISTALTIC PUMPS

Remove the reference (upper pump) and waste (lower pump) pumps separately.
Detach all the pump tubes from their connectors.
Remove the screws that fix the peristaltic pump. Then pull the pump and remove it.
Place a new pumps by inserting the pump axe in the hole at the center of the pump,
then push the pump in place and fix it again with its screws.
Connect again the pump tubes to the proper connectors.

Figure 11-9

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9. TROUBLESHOOTING
If the routine maintenance is performed regularly, the I.S.E. Module functions correctly. The most
common problems encountered in the I.S.E. Module are as follows:
a) Calibration errors.
b) Unreliable sample results with flags.
c) Error messages of air bubbles.
d) Occlusions in the I.S.E. bowl (funnel)
e) no I.S.E. solutions

a) CALIBRATION ERRORS
The causes may be due to various reasons and can be diagnosed through close examination of mV
values of slopes.
Typical values of calibration potentials in mV for new electrodes and fresh reagents:
K around 30 mV
Na around 15 mV
Cl around 10 mV
The above-mentioned values are indicative and may deviate due to the aging of the electrodes.
In addition to the acquired slopes values, it is important to observe also the potential of the
standards in the calibration printout.
In the optimal conditions, these values can be reproduced quite easily with slight variations around
nominal value. The potential of the standards in association with the obtained slope values, are
useful for evaluation of a correct calibration. When electrodes are not efficient, for example, when
poor or no maintenance has been performed, or in case of contamination or degradation of the
working solutions, the potential values vary considerably. This results in erroneous slopes indicating
that the operating conditions are not optimal. However, in some cases, the potentials have incorrect
values, but the slopes are apparently acceptable. Be cautious with this situation as the precision
and accuracy of tests results will be affected by an incorrect calibration.
The potential values are related to standards, thus by changing standard’s lot with another
concentration, the different potentials will be observed with the same slope values. To optimize
system performance it is fundamental that both the slope and potential values are always around
established levels.

b) UNRELIABLE SAMPLE RESULTS WITH FLAGS

This problem may be determined by one of the following causes:
- Defective electrode. Check and replace.
- Electrode to be reconditioned. Perform an I.S.E. wash.
- Contaminated reagents. Replace.
- No washing after a consistent run. Perform an Enzymatic wash.
- Air in the hydraulic system. Inspect the sampling tube for possible leaks.
- Sampling imprecision due to reagent or sample residues on the external surface of the needle,
with consequent contamination during preparation. Remove Needle and clean externally using
gauze soaked with alcohol.
- Partial occlusion of the electrode. Check there are no occlusions in the electrodes stack. To
perform this operation always wear protective devices (gloves, glasses, etc). Remove the electrodes
stack. Load a syringe with reference solution, remove the needle, insert the tip into the small
interconnection tube and flush the electrodes. If the solution does not flow correctly, inspect the
electrodes singularly.
When running many I.S.E. samples per day, the electrodes, specifically the Cl, may be periodically
obstructed. In this case, one observes an increase in the slopes of K & Na, and decrement in the
slope of Cl.
A similar error may also be caused by a partially occluded Ground electrode. Generally, the
obstructions in the ground electrode are caused by the foreign matter and not by protein. To clean
use the Cl tool and a siringe with water.

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ATTENTION: never use the Cl tool on other electrodes than Cl or Bypass, or it will damage them
and make them useless.

- Partial occlusion of the needle: remove the needle and clean it internally with the supplied tool.

Results with flag D

During the reading, the flag D on one or more electrodes indicates a drift of potential greater than 2
mV.
Results with flag R
The flag R indicates no ISE solutions. Verify and replace if necessary.

c) ERROR MESSAGES, AIR BUBBLES, FLAGS

During a calibration or a run an error message warning for "bubbles" may appear. The error may be
momentary and not appear afterwards. In this case, it means a casual formation of bubbles.
If the bubble error persists then it may be due to problems of hydraulic nature. First of all verify there
are no leaks in the hydraulic circuit. Then also verify that the electrodes chain is well tightened and
there are no possible air infiltrations.

d) I.S.E. BOWL (FUNNEL)

The I.S.E. funnel takes long time to empty. It may be caused by defective or worn peristaltic pump
for draining or an obstruction in the electrodes stack. Repair or replace.
When running many serum samples it may happen an occlusion in the I.S.E. bowl, causing many
calibration errors. In this case it is enough to remove the bowl (unscrew it from the support) and
wash it with water and a clean piece of cloth. Rinse with distilled water and place it back into its seat
fixing with the screw.

e) verify the presence of the I.S.E. solutions. Replace if necessary.

In case one or more of the above error conditions appears and it is not possible to solve the
problem, it will be necessary to call the technical assistance.

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10. I.S.E. MODULE-2P CONSUMABLES

PRODUCT PART NO. SIZE
I.S.E. Low Calibrator 943 2x20 ml
I.S.E. High Calibrator 944 2x20 ml
I.S.E. Buffer (concentrated) 947A 3x10 ml
I.S.E. Reference 948 2x125ml
I.S.E. Washing Solution 947C 3x10 ml
I.S.E. Enzymatic Solution 947D 3x10 ml
Potassium Electrode (K) 980 1
Sodium Electrode (Na) 981 1
Chloride Electrode (Cl) 982 1
Reference Electrode 984 1
By-Pass Electrode 985 1
Reference 50ml bottle with perforated cap 08-07143-01 1
Reference 50ml bottle with cap 669.9663 1
Cleaning tool for Chloride Electrode 03254 1

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CHAPTER 12
ANALYZER DISPOSAL
1. RETURNING THE ANALYZER TO THE TECHNICAL ASSISTANCE
SERVICE
The Technical Service Assistance (S.A.T.) may intervene locally, at the Lab, or at Biotecnica
Instruments S.p.A. for analyzers returned for repair.
In all cases it is necessary to decontaminate the analyzer and its parts to protect the health of
technical assistance employees.
To decontaminate the analyzer follow the procedure below, bearing in mind that any part of the
analyzer may come into contact, even accidentally, with potentially infected samples: therefore set
up adequate protection using the necessary individual protection devices.
Be very careful of any splashing of residual decontaminant when disconnecting the various tubes or
touching the various parts of the hydraulic system, after decontamination.
The procedure described below is not considered to be complete and any other action taken by the
Lab to ensure the safety of Biotecnica’s technicians is appreciated.

1.1. Operating Analyzer

1. Remove all the consumable parts, still present, from the analyzer (sample cups, test tubes,
reagent bottles etc.).
2. Put a suitable decontaminant (e.g. HCl 1N hydrochloric acid diluted at 3%) in a reagent
bottle and place it in position no. 40.
3. Start a cuvette extra wash cycle.
4. Wait five minutes after the washes have finished and then remove the decontaminant bottle
from the reagent tray.
5. Run a normal wash cycle with system solution (wash and fill up).
6. Empty the hydraulic circuit (Empty fluidics).
7. Shut down the analyzer.
8. Clean off the entire sample tray with decontaminant and a clean cloth, as well as its housing
and all the accessible surfaces of the analyzer.
For assistance at the Lab: in addition to the above, clean an area with decontaminant which is
large enough for the Technician to work.

For shipping the analyzer to Biotecnica:

In addition to the instructions seen above, carry out the following:
1. Disconnect the waste tube from the waste container.
2. Decontaminate the discharge probe by soaking it for five minutes in HCl 1N diluted at 3%,
wind the ending part up and close it in a plastic bag.
3. Disconnect the system solution tube from the system solution container.
4. Push the sampling needles all the way down into their wash wells.
5. Put the cover trays back in their places (cuvettes, reagents and samples).
6. Make sure that all moveable parts are secured tightly.
7. Pack up the peripheral devices and analyzer in their original packing

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1.2. Not Operating Analyzer

1. Remove all the consumable parts, still present, from the analyzer (sample cups, test tubes,
reagent bottles etc.).
2. Clean off the entire sample tray with decontaminant (hydrochloric acid HCl 1N diluted at 3%)
and a clean cloth, as well as its housing and all the accessible surfaces of the analyzer.
3. Push the sampling needles all the way down into their wash wells.
4. Decontaminate the discharge probe by soaking it for five minutes in HCl 1N diluted at 3%.
5. Make sure the cuvettes are empty and then fill them manually with the decontaminant
solution. After five minutes remove the solution and replace it with bidistilled water.
6. Remove the distilled water from the cuvettes.
For assistance at the Lab: in addition to the above, clean an area with decontaminant which is
large enough for the Technician to work.

For shipping the analyzer to Biotecnica:

In addition to the instructions seen above, carry out the following:
1. Disconnect the waste tube from the container, wind the ending part up and close it in a
plastic bag.
2. Disconnect the system solution tube from the container.
3. Push the sampling needles all the way into their wash wells.
4. Put the cuvettes, standard and serum cover trays back in their places.
5. Make sure that all moveable parts are secured tightly.
6. Make sure the cuvettes are empty.
7. Make sure there is no residual liquid in the hydraulic circuit or any other part of the
instrument.
8. Pack up the peripheral devices and analyzer in their original packing.

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2. ANALYZER SAFE DISPOSAL

When the instrument is no longer useable or needs to be decommissioned, follow the procedure
below, bearing in mind that any part of the analyzer may come into contact, even accidentally, with
potentially infected samples: therefore set up adequate protection using the necessary individual
protection devices.
Be very careful of any splashing of residual decontaminant when disconnecting the various tubes or
touching the various parts of the hydraulic system, after decontamination.
ATTENTION: this procedure will damage the I.S.E. sensors/electrodes, after the procedure
discharge the electrodes.

1. Remove all the consumable parts, still present, from the analyzer (sample cups, test tubes,
reagent bottles etc.).
2. Empty the hydraulic circuit (empty fluidics).
3. Remove the system solution tube from the external container and put it in a container with at
least two liters of suitable disinfectant or decontaminant (e.g. hydrochloric acid HCl 1N
diluted at 3%). Put disinfectant also in a bottle in position 40 of the reagent tray
I.S.E.: replace the reference solution bottle with the decontaminant solution
4. Fill the hydraulic circuit again by running a reset and a series of primes of the washing
station and the needles.
5. Run a prime of the I.S.E. module.
6. Run a wash of the cuvettes.
7. Wait five minutes. Remove the disinfectant from all the containers and replace it with water.
Put the water tube back in the container which has just been filled.
8. Run a wash of the cuvettes and I.S.E. again, this time with water, and then empty the
hydraulic circuit again.
9. Shut down the analyzer.
10. Remove all the cords connecting the UPS to the mains and peripheral devices from the
analyzer.
11. Remove all connections to the peripheral devices (keyboard, mouse, printer and UPS).
12. Carefully clean off the entire sample tray with decontaminant (hydrochloric acid HCl 1N
diluted at 3%) and a clean cloth, as well as its housing and all the accessible surfaces of the
analyzer.
13. Carefully clean the peripheral devices using a clean cloth and a disinfectant.
14. Remove the waste probe from the container and soak it for five minutes in disinfectant (HCl
1N diluted at 3%). Then rinse it in water, wind the ending part up and close it in a plastic bag.
15. Remove all the tubes which are part of the washing, distribution and sampling hydraulic
circuit and the I.S.E. circuit. Remove the I.S.E. sensors as well.
16. Sort the material from decommissioning the instrument so that they can be recycled or
disposed of as special waste in accordance with local laws.

If the analyzer is going to be returned to the Distributor, make sure all the removal parts of the
system are bagged and separated after decontamination so that they can be disposed of as special
waste.

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3. ELECTRIC AND ELECTRONIC DEVICES DISPOSAL

ATTENTION:
Waste Electrical and Electronic Equipment, called WEEE must be disposed of in
accordance with European Directive 2012/19/EU and 2011/65/UE.

The points below provide some instructions related to disposal of WEEE, however we recommend
consulting the aforesaid Legislative Decree for additional information.

1. WEEE must not be disposed of as urban waste, it must be recycled.

2. Municipalities guarantee operation, access and suitability for recycling systems for WEEE,
so that end users and distributors can return to collection centers all waste produced within
their territories, at no cost.
3. WEEE can be returned to the distributor when new equipment is purchased, without
prejudice the provisions of Legislative Decree 151/05.
4. The distributor has the obligation to take the WEEE, however pick up may be refused when
there is a risk of contamination of personnel assigned to this job.
5. The presence of hazardous substances in electrical and electronic equipment requires
separate disposal due to the potential effects on the environment and humans. Improper use
of the same equipment or its parts may be potentially hazardous.
6. The symbol that indicate separate disposal of electrical and electronic equipment is a trash
container on wheels with a cross over it as indicated below: the symbol is printed in a visible,
readable and indelible manner

Editor’s note: The picture is only for the purposes of example: see the printed version in the Italian Official
Gazette no. 175 of 29-7-2005

7. Legislative Decree 151/05 includes a list of fines for illegal disposal of WEEE.

NOTE:
The manufacturer shall not be held liable for any failure to comply with regulations regarded to
delivery of the instrument to third parties. Check the pertinent lists at specialized waster disposal
centers.

Constraint: It is left to the responsible laboratory organization to determine whether electric and
electronic components are contaminated or not. If contaminated, treat them in the same way
as the instrument and analyzer, before disposal.

For more information about disposal of your product, please contact your city office, waste disposal
service.

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CHAPTER 13
MAINTENANCE & TROUBLESHOOTING
1. MAINTENANCE AND CARE
MAINTENANCE
It is of extreme importance that the instrument is fully turned off and the power cord unplugged from
the wall outlet to safely perform any maintenance or service procedure.
During maintenance procedures, the safety and warning precautions must be observed as outlined
in this manual.
The exterior of the analyzer casing may be cleaned periodically to remove dust, grease and other
contamination. It is not necessary to clean the inside. Use soft cloth dampened with a mild solution
of a neutral detergent with water.
The owner shall be responsible for maintenance of the analyzer. Wear or damage caused by lack of
normal maintenance or by misuse of the analyzer shall not be considered as defective workmanship
and material.

1.1. Cleaning Of The Instrument

It is a Good Laboratory Practice (GLP) to maintain the instrument in optimal operating conditions.
The instrument should be fully turned off and the power cord unplugged from the wall outlet prior to
performing any cleaning procedure. Always wear suitable protective devices such as protective
gloves, protective glasses, white coat, etc.
The exterior of the analyzer casing may be cleaned periodically to remove dust, grease and other
contamination. Use soft dusting cloth dampened with distilled water or a mild solution of a neutral
detergent with water. Do not use alcohol, solvents, or abrasives.
Use appropriate soft lint less cloth or tissues for LCD Display cleaning. Clean gently and avoid
excessive rubbing to prevent damage to the LCD surface. Do not use any liquid that may damage
the invisible matrix of the touch screen, where present.
Protective gloves and laboratory coats/gowns should be worn to prevent contamination when
cleaning the inside of the reagent chamber or serum plate chamber because of liquid contaminants.
Use appropriate disinfectant for the thorough cleaning and elimination of biological residues.
Clean the cuvettes thoroughly with approved dedicated solution.
Immediately eliminate any traces of serum drops or liquid contaminants using appropriate
disinfectant to avoid difficulties associated with removal of dry and tenacious contaminations.

1.2. Preventive Maintenance

Washing the cuvettes daily and weekly is part of the analyzer maintenance.
When the analyzer is turned off, it will ask to wash the cuvettes with the dedicated solution.
If the analyzer is never turned off, it will be the operator's responsibility to perform the necessary
cuvettes wash every day with the appropriate solution.
Washing the cuvettes helps guarantee efficiency and long life for the reading cuvette.

Exercise extreme care to ensure that the system is regularly provided with proper maintenance and
care to avoid any problems and malfunctions, which can potentially generate erroneous results. This
will give longest life at lowest overall cost.
The maintenance is normally performed at regular intervals or whenever the operating conditions
dictate it. Failure to follow proper maintenance and replacement procedures may result in system
malfunction.

The software programmed maintenance does not exonerate the user from neglecting any
unexpected problems.

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For the reasons just mentioned, we recommend that the operator follows the suggestions below.
The following simple steps serve as practical guidelines in establishing your care and maintenance
program.
1. Review the various items expiry dates, in order to have the necessary replacement parts
available when necessary.
2. Replace the worn out component soon after the on-screen message from the maintenance
software has been displayed.
3. Any consumable part showing signs of wear or damage should be immediately replaced,
even if the appropriate on-screen message is not already displayed.
4. Use only original Manufacturer’s parts. Do not replace defective parts with non-original parts
as this will cause malfunctioning of the analyzer. In case of any doubt, contact the
Manufacturer or nearest service center.
5. Use only bi-distilled water for the system solution used for the washes performed during
working phases.
6. Use only Manufacturer approved wash solution for the routine washing procedures and at
the end of working session.
7. During routine maintenance, exercise extreme caution to avoid any contamination. When
handling waste container etc. accidental contact with potentially contaminating liquid is
possible. For individual safety, use suitable protective garments, such as overalls and
gloves.

1.3. Maintenance
For the I.S.E. items, refer to the dedicated chapter.

The maintenance should be performed only by well qualified personnel.

Hereafter are presented some guidelines to help the operator in case of urgent replacements. In this
case the operator can replace the necessary items, but then it will be anyway necessary to call the
technical assistance service.
Peristaltic pump cartridge: remove both ends of the peristaltic pump tubing from the manifold.
Squeeze the locking catches and remove the defective cartridge. Place the new cartridge on the
drive shaft and gently press to snap-fit. Carefully attach the pump tubing to both fittings in the
manifold. If available in the Kit, follow the instructions in the corresponding P.O. (operative
procedure).

Photometric Lamp
The analyzer verifies lamp efficiency and stability, and alerts the user through appropriate
messages in case of fault.
Precautions for handling the halogen lamp:
Turn off power and remove the power cord from the wall outlet before servicing. The replacement of
the halogen lamp can be done by removing its cover panel.
Always allow the burnt out lamp to cool down.
Never touch the reflector or the lamp with bare fingers. Use a rag when changing.
If the lamp is touched inadvertently during installation, clean the lamp or reflector with alcohol and
dry with a clean, soft cloth before burning. Contamination of the lamp or reflector may reduce lamp
performance.
It is recommended to initially burn the new lamp for about 40 minutes before analyzer operation.
Release the lamp assembly by gently sliding upwards (ref. 1), then detach the lamp from the socket
and remove the burnt out lamp.
Insert a new halogen lamp fully into the socket.

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Slide the lamp assembly onto the light cone, orienting the lamp socket connectors in the vertical
position (ref. 2 - the socket spring clips will be horizontal). NOTE: after having replaced the lamp, it
is mandatory to run a Lamp setup from the Analyzer Utilities.

Note: the reading cuvettes are also part of the reading station, but they do not need to be replaced
unless it is impossible to wash them correctly or they break. If they need to be replaced contact the
Technical Assistance Service.

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2. MALFUNCTIONS

2.1. TROUBLESHOOTING
The risk of encountering system malfunctions is very low if the routine care and maintenance
procedure and the instructions in the operating manual are strictly observed. Refer to the
troubleshooting guide below and the subsequent text regarding symptoms and corrective actions.

The instrument or one of its peripheral devices does not turn on

Verify that the UPS group is turned on, the electrical cables are correctly connected and check the
fuses. If fuses need replacement then observe the following procedure:
1) Turn off the instrument by pressing the main switch on the rear panel and unplug power cord.
2) Extract the fuse-holder, discard the old fuses and replace with new fuses, which match the
selected voltage rating indicated on the rear panel label. Insert the fuse-holder into the compartment
and push until its latch snaps back into the position.

NOTE: the following troubleshooting guide is only to give hint a of the possible malfunctioning.
In many cases it is possible to solve the problem simply resetting the analyzer.
Any maintenance and malfunction diagnosis should be performed by the technical assistance
service.

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2.2. SCREEN MESSAGES

2.2.1. Screen Messages - Causes And Remedies

The BT analyzers software has a built in Auto-diagnostic function, which is enabled during normal
working sessions. This function allows verification of any system malfunction or lacking of any
solution necessary for running the tests.
In presence of any system malfunction, an appropriate message is displayed on the screen
indicating the type of error and the suggested solution. The system stops until the causes of error
are eliminated and then the operation can be resumed from where it stopped.
When anything necessary for test run is lacking (for example reagent or sample) an appropriate
message is displayed on the screen, sampling procedure for the missing element is interrupted
while the analyzer continues with the next working phases.

The error SAMPLE IS MISSING is displayed when the

SAMPLE IS MISSING
analyzer detects the absence of sample through a built-
in liquid sensor. It is subdivided into NO ROUTINE, NO
NO ROUTINE #XX
STAT, NO STANDARD, NO CONTROL. After this
NO STAT #XX
message the sampling of the missing sample is
NO STANDARD #XX
interrupted. It is possible to run remaining tests using the
NO CONTROL #XX
rerun commands after the problem is solved.
The error REAGENT IS MISSING is displayed when the
REAGENT IS MISSING analyzer detects the absence of reagent needed for test
run. After this message the sampling of the missing
NO REAGENT XXX reagent is interrupted. It is possible to run remaining
POSITION XX tests using the rerun commands after the problem is
solved.
The error message NO SAMPLE DILUENT is displayed
when the analyzer detects the absence of sample
NO SAMPLE DILUENT diluent solution. The testing of samples to be pre-diluted
is interrupted. To solve the problem add fresh diluent
solution and re-run the sample.
NO I.S.E. SOLUTIONS Refer to the dedicated chapter.
The message No Water appears when system solution
does not reach the analyzer because the external
system solution container is empty or defective loading
pump. When this message is displayed, the sampling
- WARNING -
procedure for programmed tests is stopped. Fill the
NO WATER
external system solution container to continue the tests.
If the error message persists, because of defective
loading pump, contact the approved technical
assistance.
The message is displayed when, during a prime, the
REAGENT NEEDLE analyzer detects an obstruction in one of the two
OBSTRUCTED...! sampling needles. Following this message the analyzer
SAMPLE NEEDLE goes into fatal error. It will be necessary to remove the
OBSTRUCTED...! needle and clean it with the supplied tool or replace it.
If the error message persists call Technical Assistance.

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2.2.2. Screen Messages Requiring Technical Assistance

VACUUM SYSTEM: This message appears when the vacuum pump inside
the analyzer has lost efficiency and the vacuum level is
- WARNING – below the internal limit. Call the technical assistance
LOW PRESSURE
The message is generated by an incorrect home
position of the sample tray. This error can be caused by
ERROR RESETTING a defective position sensor. Press F5 (Reset) key to
SAMPLE TRAY restore correct analyzer operation. In case of defective
position sensor contact qualified technical assistance to
solve the problem.
The message is activated by an incorrect zero
positioning of the reagent tray. This error can be caused
ERROR RESETTING REAGENT by a defective position sensor. Press F5 (Reset) key to
TRAY restore correct analyzer operation. In case of defective
position sensor contact qualified technical assistance to
solve the problem.
The message is generated by an incorrect zero
positioning of the dilutor piston. This error can be caused
either by an excessive piston friction or a defective
position sensor. In the event of friction it is sufficient to
ERROR RESETTING DILUTOR disassemble and clean the piston with a soft cloth
dampened with alcohol, reassemble and then press F5
(Reset) key to restore correct analyzer operation. In
case of defective position sensor contact approved
technical assistance to solve the problem.
The message is generated by a position sensor error of
the cuvette tray. Press F5 (Reset) key to try to restore
ERROR RESETTING CUVETTE
the correct operation of the analyzer. If this does not
TRAY
solve the problem, then it will be necessary to contact
approved technical assistance.
The message is generated by a defective position
ERROR RESETTING ARM sensor of the arm. Press F5 (Reset) key to restore the
ARM (HORIZONTAL) correct analyzer operation. If the problem persists, then
contact approved technical assistance.
The message is generated by an error during up/down
motion the sampling needle. This error may be caused
by a deformed needle, obstructions (i.e. improper
ERROR RESETTING ARM placing of the reagent bottles) or a defective position
(VERTICAL) sensor. As regards obstructions, just place the bottles
correctly. Afterwards press F5 (Reset) key to restore
correct analyzer operation. In case of defective position
sensor or if the needle is deformed, contact approved
technical assistance.

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A defective position sensor of the washer module

ERROR RESETTING WASHING generates this message. Press F5 (Reset) key to restore
STATION correct analyzer operation. If the message persists,
contact approved technical assistance.
This message indicates a system error. It does not allow
IMPOSSIBLE TO RESET the continuing of working phases. Turn off and then on
ANALYZER the analyzer. If the message persists, contact approved
technical assistance.
This occurs if the analyzer responded to the hardware
reset but failed to complete the initial reset procedure
within 45 seconds. It usually means that the master has
PROBLEM RESETTING THE
lost programming or some device has blocked the I2C
ANALYZER: Time-Out! Bus. Turn the system off and on to try to restore the
situation. If the message persists, call technical
assistance.
This message indicates a system error. It does not allow
the continuing of working phases. Turn off and then on
SYNCH ERROR
the analyzer. If the message persists, contact approved
technical assistance.
This message indicates a total blockage of the system.
SYSTEM BLOCKED
Turn off and then on the analyzer. If the message
CALL ASSISTANCE
persists, contact approved technical assistance.

2.2.3. Optical System Verification Messages

The message is displayed after a photometric zeroing,
when the analyzer detects that the optical system has a
lower efficiency than the minimum value stored. When
- WARNING -
this message is displayed it is not possible to continue
LAMP PROBABLY OFF
sampling tests. Replace photometric lamp and perform
Photometric Zeroing. In case the error message still
persists, contact approved technical assistance.
The message is displayed after a photometric zeroing,
when the analyzer detects that the optical system has at
340nm a lower efficiency than the minimum value
stored. The sampling tests are not stopped after this
- WARNING - message. It is necessary to replace the lamp and repeat
LAMP PROBABLY EXHAUSTED the Photometer zeroing. If after observing these steps,
the message no longer appears, then it is possible to
continue testing.
In case the error message still persists, contact
approved technical assistance.
The message is displayed after resetting the analyzer
ERROR IN OPTICAL GROUP and indicates an optical group malfunction. Contact
approved technical assistance.
The message is displayed after a photometric zeroing,
CUVETTES TRANSMISSION when the analyzer detects optically unusable cuvettes.
OUT OF LIMITS In this case the immediate intervention of the specialized
technical personnel is required.

IMPORTANT NOTICE:
The above-mentioned messages are only a partial representation of all the possible warnings that
the analyzer may output to the user. In case of any messages that are not covered here or are not
clear, please contact the nearest Technical Assistance Dept..

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CHAPTER 14
SHORT INSTRUCTIONS
1. UNPACKING INSTRUCTIONS
The crates can be easily opened by applying the lever action, with a large screwdriver, to remove all
the spring clips at the base of the crate as shown in the figure below. Carefully remove the covering.
Remove the analyzer and place it on a stable vibration-free surface. Carefully unpack all the
accessories and place them in a protected place. Store the empty crate in a safe place for future
use.

Figure 14-1

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1.2. External PC and peripherals connection

THE ANALYZER MUST BE IN OFF POSITION AND UNPLUGGED DURING
THE INSTALLATION PHASES.

The analyzer and its PC must be connected to an UPS unit to avoid damages in case of electrical
spikes. This is important also to let the operator know when there is a power failure in order to take
the necessary actions.
Connect main power cable from the instrument to the UPS and connect the latter to the main wall
outlet. Power circuit should respect current laws and have a
good earth connection.

The printer and peripheral devices should be connected to

the appropriate accessory power connectors on the analyzer
rear panel (adjacent to main power inlet) or to the UPS.
Laser printers should never be powered directly to the
analyzer.

Figure 14-2

1.3. Fluidic connections

The analyzer has rear connection to four liquid containers: one for system solution, one for the
detergent solution, one for the clean waste (system solution and detergent) and one for the
biological waste from cuvettes and needles. The containers should be placed below the analyzer’s
table.
On the rear panel there are the connectors to the analyzer’s hydraulic circuit.

Figure 14-3
CAUTION: In case of malfunctioning liquids may spill on the floor by the overflow tubes.
These liquids do not show biological hazard. Carefully read Biotecnica’s solutions inserts for
information on the products.

SOLUTIONS USED (see also Chapter 16, Par. 2.2 for ordering information)

- SYSTEM SOLUTION: double distilled water + surfactant (see Used solutions/detergents for more
details on solutions)
- DETERGENT SOLUTION: double distilled water + detergent (see Used solutions/detergents for
more details on solutions)

FOR THE COMPLETE INSTALLATION OF THE ANALYZER AND ITS PARTS, REFER TO THE
DEDICATED CHAPTER IN THIS MANUAL.

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1.4. Turning on the instrument for the first time

1. Turn on the UPS device as described in the appropriate manual.
2. Verify that the PC and peripherals are turned on and that the PC is connected to the analyzer via
USB cable.
3. Verify that the liquids (system solution and detergent) and the waste containers are in place.
4. Turn the analyzer on by means of the button on the rear side of the analyzer.
5. Load the analyzer operative program from the PC.

With the first start-up the analyzer will load also all microprocessors programming. This process will
take some minutes and it is performed only at the first start-up or in case of an upgrade.
The start-up process includes the loading of the operating system (bootstrap) into the memory. At
the end of the boot (loading of the operating system), the instrument activates all the devices and
performs mechanical, hydraulic and electronic checks.
Once turning on procedure has completed (lasting few minutes), wait for the system to warm up.
In the meanwhile, it will be necessary to perform a series of primes to make sure all the hydraulic
circuits are filled and there are no bubbles left. From the menu Analyzer, select Analyzer Utilities.
Alternatively, open the Special functions menu on the side bar and select Analyzer Utilities.
Perform the following:
- Needles prime
- Washing station prime

During warm-up phase the temperature indicator flashes on the bottom right of the display until the
appropriate temperature is reached. The instrument reaches the steady state after approximately 30
minutes (from switching the green ON/OFF button).

NOTE: Refer to the installation chapter to correctly start the analyzer.

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CHAPTER 15
COMMUNICATION AND SOFTWARE INSTALLATION
IMPORTANT NOTICE & WARNING

Important Notice:
Any modification to the internal serial protocol is restricted to qualified personnel only. Biotecnica
Instruments warrants the correct operation of the internal serial protocol, but does not assume any
responsibility for any changes made by any third party. The responsibility for any malfunction arising
out of any modifications to the scripts of the internal serial protocol rests with the customer.

WARNING
This information regards the setting up of the barcode for sample tubes identification. The reading of
the sample barcode label has the same progression as patient code.
For example: Once a patient code of 15 characters has been entered, then a code of 8 characters
followed by 7 empty spaces to reach the 15 characters is sent.
The code read on the barcode label must have the same sequence 8 + 7 for correct detection.

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1. ASTM PROTOCOL: INTRODUCTION

This chapter explains the standard ASTM protocol developed to allow bidirectional interface
between LIS and the analyzer.
The communication standard refers to the ASTM E1381-95 protocol.
The standard protocol refers to the ASTM E1394-91 protocol.
To purchase, consult or further info on the ASTM protocol, you can visit the website www.astm.org.
Specifically see:
ASTM E1381-02 Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems
https://www.astm.org/DATABASE.CART/WITHDRAWN/E1381.htm
ASTM E1394-97 Standard Specification for Transferring Information Between Clinical Instruments
and Computer Systems (Withdrawn 2002)
https://www.astm.org/DATABASE.CART/WITHDRAWN/E1

The communication can be obtained both with RS-232 serial interface, and with TCP/IP version 4.

The LIS may be a computer system as well as any applicative software to which the analyzer is
connected.
A message is intended as the "information unit" to be received/transmitted with the ASTM protocol,
therefore the whole set of characters composing the sequence to be sent/received.
In the representative tables are outlined only the fields used by the analyzer. All the other
information are not archived or processed.

1.1. Protocol Details

Communication phases:
As specified in the ASTM E1381-95 standard, the communication takes place in four phases:

1. The transmitting unit establishes the communication sending an ENQ (0x05) and waits
an ACK (0x06) to proceed or a NAK (0x15) if the receiver is not available.
2. All messages composing a pack are sent
3. Wait for an ACK (0x06) to proceed with the following sending or a NAK (0x15) to re-
transmit in case of error.
4. Transmission of the character EOT (0x04) to terminate the communication and go back
to the waiting status.

Structure of the messages:

All messages are structured as per the ASTM E1381-95 specifications.
• The first character is an STX (0x02)
• The second character is a Frame cyclic counter between 0 and 7. The first message
after ENQ, will always start with the counter set at 1. The counter will increase at every
frame, and, after having reached the value 7, will be set to 0 and the sequence will start
again.
• The terminator is the character ETX (0x03) if the single frame length is less or equal to
240 characters. Otherwise the frames are divided in sub-messages of 240 characters
max, terminating with ETB (0x17), except the last one which will terminate with ETX
(0x03).
• After the ETX or ETB characters, two checksum characters will follow.
• The message terminates with the sequence CR (0x13) LF (0x10)

Checksum calculation:
The calculation is performed upon the ASTM specifications, starting from the frame number to
the ETX or ETB characters included. The sum of every ASCII character value must be
performed. The 256 module of the sum must be calculated and transformed into hexadecimal of
length 2 (00 to FF).

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Messages composition
• The messages part is structured in fields divided by the character '|' (pipe).
• The fields can be divided into sub-fields separated by the character '^'.
• The field information may be repeated in a single message using the character '\'.
• The fields content may be:
o Null
o Numerical value expressed in decimal numbering and using as separator the
character '.'
o Text, i.e. an ASCII characters sequence, without any formatting, tabulation or other.
The single characters will be comprised between the ASCII 0x20 and the ASCII
0xFF.
o Date/time always expressed as YYYYMMDD, YYYYMMDDHHMMSS or HHMMSS.

1.2. Messages Sequence

Messages sequence in sending:

HEADER
PATIENT 1
ORDER 1
COMMENT 1
......
ORDER n
COMMENT n
......
PATIENT n
ORDER 1
COMMENT 1
......
ORDER n
COMMENT n
TERMINATOR
Or:
HEADER
PATIENT 1
ORDER 1
COMMENT 1
......
ORDER n
COMMENT n
TERMINATOR
…....
HEADER
PATIENT n
ORDER 1
COMMENT 1
......
ORDER n
COMMENT n
TERMINATOR

Note: It is advisable to send every single patient as single block (second example) because if this is
not accepted, the following will not be discarded. On the contrary, when samples are sent all in one
block, if one is not accepted, the following will be discarded.

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Messages sequence in receiving:

HEADER
PATIENT 1
RESULT 1
......
RESULT n
......
PATIENT n
RESULT 1
......
RESULT n
TERMINATOR

In the Setup there is the option: Only one header/terminator frame.

If the option Only one header/terminator frame is disabled, the Header and Terminator
frames will be present for each single sub-message. Otherwise (Only one
header/terminator frame enabled) the Header will be present only for the first message
and the Terminator only for the last one.
For instance, the analyzer must send the following message:
HEADER
PATIENT 1
RESULT 1
RESULT 2
RESULT 3
TERMINATOR

And this message has to be divided into sub-messages, it will be possible to have the
following options:
Option Only one header/terminator frame disabled (default)
First message
HEADER
PATIENT 1
RESULT 1
TERMINATOR

Second message
HEADER
RESULT 2
RESULT 3
TERMINATOR
Option Only one header/terminator frame enabled
First message
HEADER
PATIENT 1
RESULT 1

Second message
RESULT 2
RESULT 3
TERMINATOR

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1.3. Analyzer Programming

Header [H]
This message contains only the identification data of the message sender. None of these
information is memorized in the analyzer software. The only used fields are the delimiter
ones.
Rif. ASTM Field Field Name Length Content Note
E1394-91 Number
7.1.1 1 Record Type ID 1 H Identifies the message Header (fix)
7.1.2 2 Delimiter definition 4 |^\& Delimiter (fixed)

Patient [P]
Single patient basic information memorization.
Rif. ASTM Field Field Max Content Note
E1394-91 Number Name Length
8.1.1 1 Record 1 P Identifies the message Patient (fix)
Type ID
8.1.3 3 Patient ID 30 Patient code It is the patient's unique ID code
8.1.6 6 Patient 60 Surname^Name Patient's Surname and name
Name
8.1.8 8 Birth Date 8 YYYYMMDD Patient's date of birth
8.1.9 9 Patient Sex 3 M, F, C, G1, G2, Sex (group) of the patient
G3, G4, G5, G6, • Groups from G1 to G15 are the user-defined
G7, groups
G8, G9, G10, G11, • If it is sent Unknown or null the default Man will
G12, G13, G14, be used
G15
8.1.15 15 Clone 5 CLONE, REPEAT If the string 'CLONE' is inserted, the patient is a clone of a
or nothing sample already present on the analyzer. If the string
'REPEAT' is inserted, the patient is a repetition of a
sample already performed.

8.1.16 16 Specimen 1 or S, U, C, O Type of element (Serum, Urine, CSF, Other)

Type more If urine is passed, it is possible to add the diuresis with a
float value (the decimal point must be '.'), spaced by the
field separator ^
Example: U^10.3

8.1.23 22 Note (line 40 Patient’s note Lab notes

1)
8.1.23 23 Note (line 40 Patient’s note Lab notes
2)
8.1.24 24 Admission 8 YYYYMMDD Admission date
Date

Order [O]
Memorization of the information related to one or more analyses that have to be assigned to
the patient
Rif. Field Field Name Max Content Note
ASTM Number Length
E1394-91
9.4.1 1 Record Type ID 1 O Identifies the message Order (fix)
9.4.5 5 TestCode1^TextCode2^{..} 50 Test Analyses test code
Code/Codes
9.4.6 6 Test priority 1 Patients list (R, Identifies the list where the patient must be
S) memorized
9.4.16 16 Specimen Type 1 S, U, C, O Type of element (Serum, Urine, CSF, Other)

Comment [C]
Memorization of the comment related to the last analysis sent for the patient
Rif. ASTM Field Field Name Max Content Note
E1394-91 Number Length
11.1.1 1 Record Type ID 1 C Identifies the message Comment (fix)
11.1.4 4 Comment Text 200 Comment Comment text for the last inserted analysis

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Terminator [L]
This message terminates the communication
Rif. ASTM Field Field Name Max Content Note
E1394-91 Number Length
13.1.1 1 Record Type ID 1 L Identifies the message Terminator (fix)
13.1.3 3 Terminator Code 1 F Closes the data pack (fix)

Note:
• Even thou the system allows sending of more analyses with the Order pack, if a comment is
necessary for one single analysis, this must be sent as sole analysis for the pack, followed
by the related comment.
• If the Speciment Type is passed, both on the patient pack and on the analyses pack, then
only the last specimen is taken into consideration. For example, if urine passes on the
patient and serum passes on the analysis package, the final patient will be on serum and not
urine.
• If a CLONE is passed and no patient is present on the instrument with that code, the entire
package will be discarded
• If a REPEAT is passed and the patient with that code does not exist on the instrument, the
whole package will be discarded - Warning: it is not possible to repeat a Clone patient as the
instrument does not know which sample to refer to, since for cloned patients there are more
records with the same code
• If more Order packs are sent for a single patient and only one contains as Test priority the
identification as urgent, the whole patient (with all the related analyses) will be placed in the
STATs list.

1.4. Receive Report

Header [H]
This message contains only the identification data of the message sender.
Rif. ASTM Field Field Name Length Content Note
E1394-91 Number
7.1.1 1 Record Type ID 1 H Identifies the message Header (fix)
7.1.2 2 Delimiter definition 4 |^\& Delimiters (fixed)
7.1.5 5 Sender ID Max 50 Program ID^Version Analyzer name and software version
7.1.14 14 Date Time 8+2 YYYYMMDD^Time Zone Sending date + time zone if different from 0

Patient [P]
Sends a single patient basic information
Rif. ASTM Field Field Name Max Content Note
E1394-91 Number Length
8.1.1 1 Record Type 1 P Identifies the message Patient (fix)
ID
8.1.3 3 Patient ID 30 Patient code It is the patient's unique ID code
8.1.6 6 Patient Name 60 Surname^Name Patient's surname and name
8.1.8 8 Birth Date 8 YYYYMMDD Patient's date of birth
8.1.9 9 Patient Sex 3 M, F, C, G1, G2, Patient's sex (group) (Groups from G1 to G15 are the
G3, G4, G5, G6, user-defined groups)
G7,
G8, G9, G10, G11,
G12, G13, G14,
G15
8.1.16 16 Specimen 1 S, U, C, O Type of element (Serum, Urine, CSF, Other)
Type
8.1.23 22 Note (line 1) 40 Patient’s note Lab notes
8.1.23 23 Note (line 2) 40 Patient’s note Lab notes
8.1.24 24 Admission 8 YYYYMMDD Admission date
Date

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Result [R]
Sends a single test result
Rif. ASTM Field Field Name Max Content Note
E1394-91 Number Length
10.1.1 1 Record Type ID 1 R Identifies the message Result (fix)
10.1.3 3 Test Code 4 Analysis code Analysis unique identification code
10.1.4 4 Result 10 Result Result expressed in concentration
10.1.5 5 Units 30 Units Units
10.1.6 6 Range 20 Min^Max Normal values range
10.1.7 7 Flag 10 Flags Analysis flags separated by ^
10.1.9 9 Status 1 F Result status (fix)
10.1.11 11 Operator 30 Operator Operator name
10.1.12 12 Start Date 8+2 YYYYMMDD^Time Zone Test start date + time zone if different from 0

Terminator [L]
This message terminates the communication
Rif. ASTM Field Field Name Max Content Note
E1394-91 Number Length
13.1.1 1 Record Type ID 1 L Identifies the message Terminator (fix)
13.1.3 3 Terminator Code 1 N Closes the data pack (fix)

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1.5. Host Query

With the Host Query option enabled, when an unknown patient bar-code is read (patient data not
present in the software) a request is sent to the Host computer to send the patient data and related
analyses for that unknown code. Moreover the analyzer can send to the Host computer a message
containing the sending patients outcome, which may be positive or can contain errors.
The latter can be disabled in the Setup (see chapt. 9, par. 2.2)

Request for patient data + analyses data:

To the host is sent a request as follows:

HEADER
INFORMATION
TERMINATOR

Where Header and Terminator are the same used in 1.4. Receive report, while Information
has the following format.

Information [Q]
Information request related to a specific code

Rif. ASTM Field Field Name Max Content Note

E1394-91 Number Len
12.1.1 1 Record Type ID 1 Q Identifies the message Information (fix)
12.1.5 3 Patient ID 30 Patient code It is the patient's unique ID code
12.1.13 13 Type 1 O Patient data request + test

As answer, the LIS will send a pack containing the patient data and the test to be performed for that
code, as specified in 1.3. Analyzer Programming
.
Sending errors/status to LIS:

A request as follows is sent to the host:

HEADER
TERMINATOR

Where Header and Terminator are the same used in 1.4. Receive report. Only the
Terminator Information field is modified (Rif. 1394-91 13.1.3) as it may contain one of the
following codes:

Code Type
F Sending result OK
T The sender has aborted the communication
R The receiver has aborted the communication
Q Last pack had an error in contents (usually an error in the analyses codes – too many analyses or unknown analysis
code)

ATTENTION: when the query mode is activated, make sure that the host is connected, as the
operative program has a 60 seconds timeout for each single request. In case the host is not
connected, the analyzer might stop working for a long time.

When sending a patient in host query mode (Q+P), the error/state messages are not sent in order to
make the work faster.
Sending of the error/state messages can be disabled in the Setup (Setup/Protocol ASTM/Use Query
Mode/Disable auto answer mode).

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1.6. Report Request

The analyzer does not automatically transmit, but always waits for a specific request from LIS.

Reports request:

A request as follows is sent to the analyzer:

HEADER
INFORMATION
TERMINATOR

Where Header and Terminator are the same used in 1.3. Analyzer Programming, while
Information has the following format.

Information [Q]
Report request for a single code or a range of codes
Rif. Field Field Name Max Content Note
ASTM Number Length
E1394-91
12.1.1 1 Record Type 1 Q Identifies the message Information (fix)
ID
12.1.5 5 Universal ID 15+15 Start Code/codes that identify the patient/patients (see table
code^EndCode 7.1)
12.1.13 13 Type 1 F Request for the final results (fix)

Tabella 7.1
Start Code End Code Note
ALL_PATIENTS - Request for all available reports
NEXT_PATIENT - Request for report of the next patient to be sent to LIS
Patient ID - Request for the patient report with patient ID equal to the sent patient ID
Patient ID Start Patient ID Stop Request for all patients reports with ID included between Patient ID Start e Patient ID Stop
(extremes included)

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2. INTERNAL COMMUNICATION

2.1. General
The analyzer allows bi-directional communication through RS 232C serial connection or via TCP-IP
transport with any host computer.
For the transport please refer to the Setup dedicated paragraph (chapter 9, par. 2.2).
The particular feature of the dialog is that it is always the host computer, which initiates the
communication for either transmitting patient list or for receiving the results.
To initiate any communication the host computer will have to send to analyzer the character STX
(0x02) and expect the character ACK (0x06) as a response. At this point the host computer will send
data to the analyzer and terminate the communication by sending the character EOT (0x04).
It is important to remember that any communication is followed by a response from the analyzer.

IMPORTANT NOTICE ON DATA TRANSMISSION

Any character below the "space" (value 32 decimal or 0x20 hexadecimal) in a String or Stringn will
be deleted.

2.2. Wiring Diagram Of Interface Cable

BT analyzer

BT analyzer

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2.3. Internal communication: variable protocol

Introduction
The variable serial protocol has been designed to provide the user with possibility to personalize the
transmitted and received data from the analyzer.

ATTENTION: WHEN A VARIABLE COMMUNICATION PROTOCOL IS CREATED OR MODIFIED

IT IS ABSOLUTELY NECESSARY TO SAVE SCRIPS AND TO COMPILE AGAIN, EVEN IF ONLY
ONE HAS BEEN MODIFIED.

The user can transmit or receive in addition to preset data (patient code, analysis code, results etc.),
also the simple text strings and/or characters in order to meet the personal requirements.

Not only the user can decide to send or receive numerical information (for example number of tests)
not as single byte but as a preset numerical string or vice versa.

For example the user can decide to receive something like:

"Initiate analysis data"

<Analysis data true and typical>
"End analysis data"

Where the phrases "Initiate analysis data" and "End analysis data" do not refer to any preset data
by the analyzer but serve only for monitoring communication process (can be useful for inserting
specific markers on those programs which obtain information from text files).

It is obvious that the protocol of initiation and end of communication, the commands for the request
of report, and the analyzer responses in case of error or success remain identical to the usual
preset serial communication.

To ask for the next report, the host will send the 'R' pack (preceded by the <STX>/<ACK> sequence
and followed by the <EOT> character. If no data is available, the analyzer will send the <NAK>
character, otherwise will send the report (both <NAK> and the report are preceded by the
<STX>/<ACK> combination and are followed by the <EOT> character).

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Notes regarding Scripts

A script is a text document. Each one of the single commands must each reside in a different line
and be complete. In other words a single command cannot be divided into more lines.

String ‘Name’|$10 -> Valid line

String ‘Name’|$10 char ‘A’ -> Invalid line

String ‘Name’
|$10 -> Invalid Command

An editor for writing, modificating, saving and compiling of one or more scripts is accessible inside
the program (setup chapter 9, par. 2.2). In any case it is possible to write a script with any text editor
(DOS or Windows) like Notepad of Windows or the EDITOR of the DOS. It is not possible to import
documents written with UNIX as the characters used for going to the next line are different from the
ones used by the DOS or Windows.

TYPE OF DATA
Character: Identifies a single character, can pass as printable character (enclosed between single
apostrophes), as decimal ASCII value (preceded by symbol $) or else hexadecimal ASCII value
(preceded by 0x).
If for example we want to identify the character A (decimal value 65 or hexadecimal value 41) then
we can write 'A', $65 or 0x41.
String: Identifies a sequence of printable characters enclosed in single apostrophes, for example:
'this is a string'.
Comment: Identifies a portion of test (preceded by a character ; which will not be compiled but will
serve as note only for the programmer.
Variables: These are particular sequence of characters preceded by the symbol #, which will be
used by the program for storing internal information (patient code, analysis name and etc.), refer to
"TABLE 1/2 - TRANSMISSION/RECEPTION".

There are also variables for direct uses, which allow for identification of any character below ASCII
32 (space) to facilitate the writing of the script (for example, one can use the variable #EOT to
identify the character $4), see "TABLE 3 - INTERNAL VARIABLES".

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SCRIPT FUNCTIONS
String: Identifies a string of fixed length

Syntax:
String <String>|<Length>

Where
<String> Transmit/receive string
<Length> String length

Note:
If the length of the text strings is less than the data length, then a series of spaces will be
added on the right to reach the data preset length. In case the text string is longer than the
data length, then the string end will be cut off to match the data length.

If the length of the numerical values is less than the data length, then a series of characters '0'
will be added to the left to reach the preset data dimension. In case the length of the
numerical values string is longer than the data length, then the string will be truncated to
match the data length.
It is not possible to use variables as parameter <Length>.

Example:
String ‘Hello Word’|$40
String #Variable1|0x10

Stringn: Identifies a string of variable length ending with a particular character.

Syntax:
Stringn <string>I<Terminator>

Where
<String> Transmit/receive string
<Terminator> End character

Note:
It is not possible to use the variables like parameter <Terminator>

Example:
Stringn ‘Hello Word’|$0
Stringn ‘My String’|’@’
Stringn #Variable1|0x10

Float: identifies a number in floating point and it is presented as String with valid characters
'0'..'9', '+', '-', '.'

FloatN: identifies a number in floating point and it is presented as a StringN with valid
characters ‘0’..’9’, ‘+’, ‘-‘, ‘.’

Integer: identifies an integer number and it is presented as String with valid characters '0'..'9'

IntegerN: identifies an integer number and it is presented as a StringN with valid characters
‘0’..’9’

Boolean: identifies a single bit (true or false) and it is presented as a Char with valid
characters ‘1’, ‘T’, ‘Y’ as true value and ‘0’, ‘F’, ‘N’ as false value

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Char: Identifies a single character (or single byte)

Syntax:
Char <Character>

Example:
Char ‘H’
Char $20
Char 0x10
Char #STX

Set: Identifies the beginning and the end of the group of repetitive commands
Syntax

Set Begin<Name of group>

Begin repetitive group
Set End<Name of group>
End repetitive group

Note:
Actually the ANALYSESDATA is the unique SET present, which identifies the analysis in
transmission/reception.
Only one command SET BEGIN and one command SET END can be present in a script.
A script must always contain the command SET.
The variable PATIENTNUMBERTEST must be present before the command SET.

COMPILATION ERRORS
One or more errors due to incorrect script writing or the system error may show up during
compilation of a script. The compiler shows the error code, the description of error, and the line
where it has been detected.
The following table shows the error codes, description, and the possible causes:
Error Codes:
01 error in Check-Sum
02 out of range numerical field
03 wrong character/command
04 datum is not numerical
05 datum is not boolean
06 UNKNOWN: program error
07 too many analyses for the patient
08 unknown analysis code
09 patient group not valid (male/female/...)
10 patient element not valid (routine/STAT/...)
11 yes/no check not valid
12 sample type not valid (serum/urine/...)
13 control level not valid (1/2/3)
14 known/unknown control not valid
15 clone yes/no not valid
16 sample tray position not valid (0..100)
17 repetition yes/no not valid
18 analyses number not valid (1..80)
19 Clone not possible (patient is missing)
20 repetition not possible (patient is missing)
21 patient position already used
22 patient position in run
23 patient already present
24 less data than the expected have been received

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TABLE 1 – TRANSMISSION

The following variables are used for the transmission of a report from analyzer to the host computer:
Variable Usage Type of valid data
PATIENTID Patient Code ID# String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
(1)
PATIENTGROUP Group String
(2)
PATIENTISROUTINE Patient List String Character
(3)
PATIENTTYPE Method Type String Character
PATIENTNOTE Descriptive Note String
PATIENTNUMBERTEST Number of Results String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
ANALYSENAME Analysis name String
ANALYSESCONCENTRATION Concentration String
ANALYSESFLAGS Flag Result String
ANALYSESMINVALUE Minimum Value String
ANALYSESMAXVALUE Maximum Value String
ANALYSESUM Unit of Measurement String
(3)
ANALYSESSERUMTYPE Method Type String Character
ANALYSESABS Absorbance String
(1)
Identifies Male, Female, Child or one of the groups (Select one of these):
‘M’ : Male
‘F’ : Female
‘C’ : Child
‘G01’ : User group 1
‘G02’ : User group 2
‘G03’ : User group 3
‘G04’ : User group 4
‘G05’ : User group 5
‘G06’ : User group 6
‘G07’ : User group 7
‘G08’ : User group 8
‘G09’ : User group 9
‘G10’ : User group 10
‘G11’ : User group 11
‘G12’ : User group 12
‘G13’ : User group 13
‘G14’ : User group 14
‘G15’ : User group 15
(2)
Identifies Routine or STAT (Select one of these):
‘R’ : Routine
‘S’ : STAT
Transmitting patient from archive will always have identifier of Routine.
(3)
Identifies the type of sample (Select one of these):
‘S’ : Serum
‘U’ : Urine
‘C’ : CSF
‘O’: OTHER

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TABLE 2 – RECEPTION

The following variables are used for reception of a patient by the analyzer:
Variable Usage Type of valid data
PATIENTID Patient Code ID# String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
(1)
PATIENTISROUTINE Patient List String Character
(2)
PATIENTGROUP Group String
(3)
PATIENTTYPE Method Type String Character
PATIENTNOTE Descriptive Note String
(4)
PATIENTISCONTROL If the patient is a control String Character
(5)
PATIENTCONTROLKNOK If it is a known control String Character
(6)
PATIENTCONTROLLEVEL Control Level String Character
(7)
PATIENTISCLONE If it is a clone String Character
(8)
PATIENTPOSITION Vial (Cup) position String Character
PATIENTNUMBERTEST Number of test String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String

(1)
Identifies Routine or STAT (Select only one of these):
$0 : Routine
$1 : STAT
‘0’ : Routine
‘1’ : STAT
‘R’ : Routine
‘S’ : STAT
‘ROUTINE’ : Routine
‘STAT’ : STAT
(2)
Identifies Male, Female or Child (Select only one of these):
'M' : Male
'F' : Female
'C' : Child
'G01' : User group 1
'G02' : User group 2
'G03' : User group 3
'G04' : User group 4
'G05' : User group 5
'G06' : User group 6
'G07' : User group 7
'G08' : User group 8
'G09' : User group 9
'G10' : User group 10
'G11' : User group 11
'G12' : User group 12
'G13' : User group 13
'G14' : User group 14
'G15' : User group 15
(3)
Identifies the type of sample (Select one of these)
$1: SERUM
$2: URINE
$3: CSF
$4: Other
'1': SERUM
'2': URINE
'3': CSF
'4': Other
'S': SERUM
'U': URINE
'C': CSF
'O': Other
'SERUM': SERUM

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'URINE': URINE
'CSF': CSF
'OTHER': OTHER
(4)
Identifies a Control or a Sample (Select only one of these):
$0 : Sample
$1 : Control
‘0’ : Sample
‘1’ : Control
‘N’ : Sample
‘Y’ : Control
‘S’ : Sample
‘C’ : Control
‘NO’ : Sample
‘YES’ : Control
‘SAMPLE’ : Sample
‘CONTROL’ : Control
(5)
Identifies a Known or Unknown Control (Select only one of these):
$0 : Unknown
$1 : Known
‘0’ : Unknown
‘1’ : Known
‘N’ : Unknown
‘Y’ : Known
‘U’ : Unknown
‘K’ : Known
‘NO’ : Unknown
‘YES’ : Known
‘UNKNOW’ : Unknown
‘KNOW’ : Known
(6)
Identifies Control Level (Select only one of these):
$1 : Level 1
$2 : Level 2
$3 : Level 3
‘1’ : Level 1
‘2’ : Level 2
‘3’ : Level 3
‘L’ : Level 1
‘N’ : Level 2
‘A’ : Level 3
‘LOW’ : Level 1
‘NORMAL’ : Level 2
‘ABNORMAL’ : Level 3
(7)
Identifies if it is a Clone (Select only one of these):
$0 : Normal
$1 : Clone
‘0’ : Normal
‘1’ : Clone
‘N’ : Normal
‘Y’ : Clone
‘NOCLONE’ : Normal
‘CLONE’ : Clone
(8)
If this field has value 0, the position is automatically assigned by the analyzer

Note:
It is not possible to repeat the patient if:
1. It is not present among the executed patients
2. No free position exists on the plate
3. The patient has already been inserted in the current list
4. The lists of execution are different
5. The Serum/Urine field is different
6. It is also selected as clone

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TABEL 3 – INTERNAL VARIABLES

Variables Decimal Hexadecimal

NUL $00 0x01
SOH $01 0x02
STX $02 0x03
ETX $03 0x04
EOT $04 0x05
ENQ $05 0x06
ACK $06 0x07
BEL $07 0x08
BS $08 0x09
TAB $09 0x0A
LF $10 0x0B
VF $11 0x0C
FF $12 0x0D
CR $13 0x0E
SO $14 0x0F
SI $15 0x10
DLE $16 0x11
DC1 $17 0x12
DC2 $18 0x13
DC3 $19 0x14
DC4 $20 0x15
NAK $21 0x16
SYN $22 0x17
ETB $23 0x18
CAN $24 0x19
EM $25 0x1A
SUB $26 0x1B
ESC $27 0x1C
FS $28 0x1D
GS $29 0x1E
RS $30 0x1F
US $31 0x20

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SCRIPT EXAMPLES

This example shows the default script in receiving patients

StringN #PatientID|$13
Integer #PatientPosition|2
Integer #PatientNumberTest|3
BeginAnalyses
String #AnalysisCode|4
EndAnalyses
Integer #CheckSum|3

The following are the details of the above Scripts:

Stringn #PatientCode|$13
Patient Code of variable length terminating with the character <Return> (13 in decimal)

Integer #PatientPosition|$2
Position of serum cup (string of fixed length equal to 2 characters)

Integer #PatientNumberTest|$2
Number of tests to be executed (string of fixed length equal to 2 characters)

Set #BeginAnalysesData
Beginning of analysis codes

Stringn #AnalysesCode|$4
An analysis code of fixed length equal to 4 characters. It must be entered for each type of test as
per quantity indicated in the #PatientNumberTest.

Set #EndAnalysesData
End of analysis codes

Integer #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)

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This example shows the default script in transmitting reports

StringN #PatientID|$13
Integer #PatientNumberTest|3
BeginAnalyses
String #AnalysisCode|4
Float #AnalysisABS|$6
Float #AnalysisConcentration|6
EndAnalyses
Integer #CheckSum|3

The details of the above scripts are as follows:

Stringn #PatientCode|$13
Patient Code of variable length terminating with the character <Return> (13 in decimal)

Integer #PatientNumberTest|$3
Number of results to be sent (a string of fixed length equal to 3 characters)

Set #BeginAnalysesData
Beginning of zone repeated for the number of results to be sent (see #PatientNumberTest)

Stringn #AnalysesCode|$04
An analysis code of fixed length equal to 4 characters

Float #AnalysesABS|$6
ABS referred to the analysis code as per #AnalysesCode (a string of fixed length equal to 6
characters)

Float #AnalysesConcentration2|$6
Concentration referred to the analysis code as per #AnalysesCode (a string of fixed length equal to
6 characters)

Set #EndAnalysesData
End of zone repeated for the number of results to be sent

Integer #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)

2.4. CALCULATION OF CHECK-SUM

This procedure calculates a control code in accordance with the transmitted or received data. An
algebraic sum of ASCII values of all the sent characters (except control characters <STX> <ACK>
and <EOT>) is executed. For example the character "A" has ASCII value 65 - 0x41.
Consequently the module 256 of the found value is executed (balance of dividing the value by 256).
This is the Check-Sum to be sent.

IMPORTANT NOTE
THE TERMINATING CHARACTERS OF VARIABLE LENGTH STRINGS DO NOT ENTER INTO
THE CHECKSUM CALCULATION

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3. SOFTWARE INSTALLATION

CD/DVD INSTALLATION
Insert the installation disk into the drive and wait for the installation program loading.
Click NEXT to start the installation
At the end of the installation click on CLOSE

USB MEMORY OR CD/DVD INSTALLATION, WITHOUT AUTORUN

Insert the installation USB or the disk
Open Explore and select the inserted device unit
Double click on the INSTALL file (answer yes to the possible question posed by Windows)
Click NEXT to start the installation
At the end of the installation click on CLOSE

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CHAPTER 16
SUPPLEMENTARY INFO
1. WARRANTY CONDITIONS
The Manufacturer, after having accurately tested this analyzer, guarantees the instrument for 1
(one) year starting from invoice or goods delivery.
The warranty includes the repairing and the replacement for free of the faulty parts due to wrong
manufacturing. Warranty is not extended to the normally consumable parts of the system.
The warranty is not valid in case of improper use, negligence, improper or lack of maintenance and
cleaning, tampering or repairing by third parties not authorized by the Manufacturer and in any case
when the cause cannot be stated as original manufacturing fault.
The costs of shipment and transport to the Manufacturer for repair or substitution, and the risks
deriving from this is the responsibility of the buyer, including all the costs of onsite technical service
at client's location (transport, board and lodging) as well.
If the stated defects will result to be out of warranty limits, the buyer will pay repair or replacement
costs.
The Manufacturer is not responsible for any unforeseen technical problem that might occur. If the
requested technical assistance is outside the terms of warranty a charge will be made to the
customer as per current rates in force.
The Manufacturer is an internationally known for its high quality standards in production. The
Manufacturer is thus responsible for providing to the customer clear and effective information for
use of its products, including all the precautions and warnings for a secure and risk-free use.
Service personnel must also refer to the warnings and cautions notices in this manual. It is the duty
of the service engineer of the Manufacturer to instruct the customer’s personnel to take all
necessary precautions during repair and handling of products.
The Manufacturer is not responsible for any damage that may be caused directly or indirectly to
persons or things due to a lack of observance of all the warnings and cautions outlined in the user's
manual, and concerning the warnings and cautions during the different working phases of the
instrument (see Warnings and precautions). Direct, indirect, incidental, special, moral damages as
well as other damages of any type (including, with no limitation, those deriving from profit’s loss,
business interruption or information loss) cannot be ascribed to the Manufacturer even in the case in
which the possibility of the event had been explicitly stated.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079
E-mail: [email protected]
Web: www.biotecnica.it

NOTES FROM THE MANUFACTURER

The Manufacturer reserves the right to revise this manual without notice, for any reason. This
includes but is not limited to, utilization of advance in the state-of-the-art and changes thereof.
Product enhancement resulting from our continuing quality improvement effort may necessitate
changes in specifications without notice. This fact doesn’t oblige the company to inform its actual
customers because the information included in the present manual refers to state of the product
when shipped, thus no warranty about notification of future changes is given.
The information contained in this manual is proprietary with Biotecnica Instruments S.p.A.
Reproduction of any part or whole may only be performed with written permission from Biotecnica
Instruments S.p.A.

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Page 1 of 1

Mod.05-35a-ing Rev. 1
Parts / Instruments Return Authorization
DATE: ______/______/____

From:
To: Technical Assistance – Export Manager
Client information
Instrument model: Serial number:

Defective part
Part description:

Code: Serial number:

Bar-code number: Quantity:
Under warranty: Yes  No  Invoice number: Date:
Description of the problem:

Request for:
Repair  Exchange  Quotation  Urgent 

Name: Signature:

Biotecnica Instruments response

Return authorization number: / 20__ Date:

Approved: Yes  No 
Repair  Exchange  Destroy  Quotation:
Note:

Approved by: Technical Assistance Dept. Signature:

Checked by: Quality Assurance Manager Signature:
NOTE: No parts or instruments will be accepted for repair or replacement without a Return Authorization number that can
be obtained from Biotecnica Instruments S.p.A. Fax this Return Authorization form to +39 06 410 3079 to the attention of
Technical Assistance/Export Manager, who will then evaluate and issue a Return Authorization number.

WARRANTY EXCTRACT: Biotecnica Instruments S.p.A. warrants its instruments to be free from defective parts and
workmanship for a period of one (1) year from the date of purchase. Liability under this warranty is expressly limited to
repair or replacement of defective parts at the option of Biotecnica Instruments S.p.A. This warranty does not cover the
results of misuse, accident or abuse of any parts of its instruments which have been repaired, tampered with or altered by
anyone other than personnel authorized by Biotecnica Instruments S.p.A. This warranty does not apply to fluid handling
devices, consumables or reagents.
Products returned to Biotecnica Instruments S.p.A. for repair or replacement shall be sent with transportation prepaid.
If found not to be defective under the terms of warranty, a charge will be made for repair or replacement and freight costs
will be at customer’s expense.

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2. ORDERING INFORMATION
For technical or ordering assistance start with our convenient ordering check list located in the
ensuing paragraph. For further assistance, don't hesitate to call your local sales/representative
office.
To obtain accessories/spare parts, address order or enquiry to your sales/service representative
and supply the following Information:
a) Instrument Model and Serial Number
b) Quantity of parts desired
c) Part Number
d) Description

If no local sales/service representative is available, order to:

Biotecnica Instruments S.p.A.
Via Licenza, 18
00156 - Rome (ITALY)
Phone: +39 06 411 2316 Fax: +39 06 410 3079 E-mail: [email protected]

NOTE:
DUE TO IMPROVEMENTS IN DESIGN AND/OR SPECIFICATIONS, SOME PRODUCTS MAY
DIFFER SLIGHTLY FROM THE DESCRIPTION.

2.1. General Terms And Conditions For Sale

ORDERS: All telephone or written orders placed by the customer are considered a binding contract
created with the Company, when a written order acceptance has been sent by the Company or the
ordered goods have been shipped. For orders with a value over Euro 250,00, the goods including
the packing cases are shipped carriage paid. All prices listed exclude VAT and all similar taxes and
the purchaser will be liable for such taxes if applicable.

SHIPMENTS: In accordance with the general provisions of law, the goods are shipped at the
customer's risk even where shipped carriage free.
The goods with cold storage temperature between 2 - 8° are shipped at controlled temperature.

CLAIMS: Any claims must be made within 10 days from the receipt of goods.

PAYMENT TERMS: The terms of payment indicated on the invoice are valid. In the event of
overdue account, interest and expenses will be applied as per the regulations introduced by Italian
Legislative Degree 231/2002 of 7 November 2002 implementing EC directive 35/2000 (official ECB
rate plus the rate established annually by the Italian government).

JURISDICTION: For any judicial contest, legal venue for both parties is Rome (Italy).

For additional information please visit our website at the following URL: www.biotecnica.it

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2.2. Consumables

PRODUCT PART NO. SIZE

Surfactant 392T 2x50ml
Cleaning Solution 395C 1x1000ml
Detergent Solution 395D 1x1000ml
Washing Solution 395W 2x100ml
Fuse RVT 10A, 250 Volt (2xT10 A L 250 V - for Analyzer) 330.6342B 1
Power Cord (for analyzer) 330.6391 1
Power Cord (for peripheral devices) 330.6400 1
Halogen Lamp 12V/50W for Photometer 330.9384 1
Cleaning Tool for Arm Needle 662.0629A 1
10 lt Cubitainer 662.1010 1
Sample Cup 2 ml 667.1040 1 (min. 1000)
Reagent Bottle 30 ml (for diluents) with cap 669.9664 1
Reagent Bottle 80 ml (white) 667.1083 1
Reagent Bottle 50 ml (white) 667.1084 1
Reagent Bottle 20 ml (white) 667.1085 1
Reagent Bottle 10 ml (white) 667.1086 1
Reagent bottle cap 667.1075 1
For I.S.E. consumables, see the dedicated chapter.

ADDITIONAL CONSUMABLES/SPARE PARTS (ONLY FOR TECHNICAL ASSISTANCE)

PRODUCT CODE SIZE

GND electrode 662.0705 1

Six-monthly maintenance kit 11-07710-01 1

Annual maintenance kit 11-07711-01 1

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3. TECHNICAL ASSISTANCE
In case of need for the Technical Assistance Service, before calling Biotecnica, please make sure
that the following information is available:

- analyzer model
- serial number
- program code (at the center of the main screen)
- analyzer configuration (printable from the External programs menu, with third level password)

For operative and applications problems, make sure all possible information is available (in addition
to the above mentioned), such as:

- analytical parameters printout

- calibration parameters printout
- calibration results in RT printout
- calibration reaction graphs printout
- samples reaction graphs printout
- real time pages printout
- possible errors or messages from the analyzer printout

Please do not return any equipment or part of the system to the Manufacturer before discussing
your problem with an authorized technical assistance representative or with the Manufacturer own
technical assistance. The Technical Assistance Service will provide a Return Authorization
Number for the Parts/Instruments Return Authorization module available in this chapter.

Reference numbers for Biotecnica Instruments S.p.A. Technical Assistance Service:

 BIOTECNICA INSTRUMENTS S.p.A.

Via Licenza, 18
00156 – ROME
ITALY

 Tel. +39.06.4112316 Fax +39.06.4103079

Technical Assistance E-mail [email protected]

Biotecnica E-mail [email protected]

 www.biotecnica.it

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4. BIBLIOGRAPHY OF ALLIED SUBJECTS

NOTE:
The following bibliography is given to supplement this manual, whose scope as an operator manual
permits only the mention or brief explanation of some subjects.

Burtis C.A., Ashwood E.R.: “Tietz Textbook of Clinical Chemistry” IInd Ed. W.B. Saunders Company,
1994

Press W.H., Flannery B.P., Teukolsky S.A., Vetterling W.T.: “Numerical Recipes” - The Art Of
Scientific Computing -, Cambridge Univ. Press, 1986

International Standard: IEC 61010-1: 2001; IEC 61010-2-081:200+ A1:2003; IEC 61010-2-
101:2002; IEC 61010-2-010:2003

International Standard CEI EN 61326-2-6 (EMC).

Directive 98/79/EC on in vitro diagnostic medical devices (1998)

2011/65/UE: Restriction of the use of certain hazardous substances in electrical and electronic
equipment

Decreto Legislativo 30 giugno 2003, n. 196 Codice in materia di protezione dei Dati Personali
(Privacy and sensitive data dispositions).

EN ISO 18113-1:2011: In vitro diagnostic medical devices - Information supplied by the

manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

EN ISO 18113-3:2011: In vitro diagnostic medical devices - Information supplied by the

manufacturer (labeling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-
3:2009)

Directive 2012/19/EU

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