BFT* II Analyzer

Instruction Manual

– Instructions for Use –

Manual Version: 3.1

Date of Issue: 2008/09

We reserve the right to make changes in the course of technical development without previous notice.

© 2008 Siemens Healthcare Diagnostics Products GmbH (formerly Dade Behring). All rights reserved.

Emil-von-Behring-Str. 76
35041 Marburg
Germany

Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval
of Siemens Healthcare Diagnostics Products GmbH.

SMN 10465104

Manual, Order Number: 1 000 893.0908

Updating
Version Date Changes
Manual Software
1.1 1.08 1996/12 Corrections
1.2 1.10 1997/08 Corrections
1.2 1.10 1998/07 Corrections
1.2 1.10 1999/10 Corrections
2.0 2.01 2000/06 New Software Version
2.1 2.01 2003/06 Ivd conformity
3.0 2.02 2005/05 New Software Version 2.02
3.1 2.02 2008/09 Name change

Trademarks *BFT II is a trademark of Siemens Healthcare Diagnostics. The BFT* II

Analyzer in the following will be called BFT* II.

Software Copyrights Software of Siemens Healthcare Diagnostics Products GmbH is the

copyright property of Siemens. All rights to this software are retained by
Siemens. You are entitled to use this software as well as the printed
documentation relating to it on one single, non-transferable workstation.

Disclaimer Siemens Healthcare Diagnostics has validated the provided instructions,

reagents, instrument, software and customizable features for this system to
optimize product performance and meet product specifications. User
defined modifications are not supported by Siemens as they may affect
performance of the system and test results. It is the responsibility of the user
to validate any modifications made to these instructions, instruments,
reagents or software provided by Siemens.

Siemens Healthcare Diagnostics Products GmbH

Emil-von-Behring-Str. 76
35041 Marburg
Germany
www.siemens.com/diagnostics
 Table of Contents

Table of Contents

1 Introduction 1-1

1.1 Intended Use 1-1

1.2 Instrument Description 1-1

1.3 Installation 1-5

1.4 Measuring Principle 1-6

1.5 Reagents 1-7

2 Operation 2-1

2.1 Operating Steps 2-1

2.1.1 Switch on BFT* II 2-1

2.1.2 STANDBY Mode 2-3

2.1.3 Measuring 2-4

2.1.4 Change Method 2-7

2.2 Change Paper 2-8

3 BFT* II Parametrization 3-1

3.1 Method Parameter 3-1

3.1.1 Menu <general> 3-4

3.1.1.1 Define Method Name 3-4
3.1.1.2 Load Preset Method 3-6
3.1.1.3 Copy Method 3-7
3.1.1.4 Exchange Method Place 3-8
3.1.1.5 Delete Method 3-9

3.1.2 Menu <1st conversion> 3-10

3.1.3 Menu <2nd conversion> 3-11

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3.1.4 Menu <measurement> 3-11

3.1.5 Method Configuration 3-12

3.1.5.1 PT Parameter 3-12
3.1.5.2 APTT Parameter 3-21
3.1.5.3 Thrombin Time Parameter1 3-21
3.1.5.4 Batroxobin Time Parameter1 3-21
3.1.5.5 Fibr. g/l Parameter 3-21
3.1.5.6 Fibr. mg/dl Parameter 3-22
3.1.5.7 Extr. Factor Parameter1 3-22
3.1.5.8 Intr. Factor Parameter1 3-22
3.1.5.9 PT-Innovin Parameter 3-22
3.1.5.10 ProC G PCAT Parameter1 3-22
3.1.5.11 ProC G PCAT/0 Parameter1 3-23
3.1.5.12 ProC FV PCAT Parameter1 3-23
3.1.5.13 ProC FV PCAT/0 Parameter1 3-23
3.1.5.14 none 3-23
3.1.5.15 none 3-23

3.2 Utilities 3-24

3.2.1 Menu <printer> 3-24

3.2.2 Menu <beeper> 3-25

3.2.3 Menu <reagent-stirrer> 3-25

3.2.4 Menu <secret number> 3-25

3.2.5 Menu <cuvette test> 3-26

4 Errors 4-1

4.1 Application Errors 4-1

4.2 Non-fatal Errors 4-1

4.3 Fatal Errors 4-3

4.4 Troubleshooting 4-5

4.5 Change Fuses 4-7

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5 Software 5-1

5.1 Software Overview 5-2

5.2 Connection to Host 5-3

5.3 Method Parameters 5-3

6 Appendix 6-1

6.1 Hazards and Precautions 6-1

6.2 Maintenance and Hygiene 6-4

6.3 Disposables 6-4

6.4 Materials provided 6-5

6.5 General Specifications 6-5

6.5.1 Disposal of BFT* II 6-7

6.6 Specifications for Safety 6-7

6.7 Meanings of the symbols on the adhesive labels of the accessories 6-8

6.8 Mathematics 6-9

6.9 Print-outs 6-10

6.10 Description of Interfaces 6-12

6.11 Terminology & Abbreviations 6-14

Index

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 1 Introduction

1 Introduction

1.1 Intended Use

1
The BFT* II is a semi-automated device intended for use to determine PT,
APTT, TT1, BT1, Fibrinogen, and single factors1.

Only for in-vitro diagnostics!

1.2 Instrument Description

The BFT* II is constructed in modular units. For visual communication a
liquid crystal display with two rows and 20 characters each has been
integrated. A membrane keypad is located below the display. The following
keys are available:
<- ->, 0 - 9, Esc, and Enter for the entry of parameters.

The measuring channels are addressed with the following keys: Incub for
the sample incubation timer, Reset for the adjustment and Start for a
manual start of measurements.
Since these keys are specific to the appropriate measuring channel, they
are placed adjacent to the measuring channel in the form of a membrane
keypad.

The arrow keys <- -> allow the operator to select the next menu from the
menu field. The numbers are used to enter method parameters. A selection
is confirmed by pressing Enter; a submenu will be displayed if appropriate.
The Esc-key cancels any operation in the parameter menu. The method
parameter menu can be accessed via the Cal-key.

Up to 15 methods can be installed. The method names may be edited freely

with the character generator.
The measuring channels are integrated in the heating block at 37.4 °C with
4 positions for reagent bottles and 15 positions for cuvettes per measuring
channel.

By adding a reagent with a pipette into the sample cuvette the measure-
ment is automatically started. The light protection cap is equipped with a
guide, designed specially for Eppendorf pipette tips, for correct positioning
of the pipette.
The light protection cap has a red tongue that allows the pipette tip to be
introduced into the cuvette once the cuvette has been inserted. This tongue
prevents anything from being pipetted directly into the measuring channel
prior to a cuvette being inserted.

A power jack, is located on the back of the instrument. The power switch is
located next to the power supply
- I switch ON
- O switch OFF
together with the fuse holder in a housing. For data output a RS 232 C 6-
pin interface port is located on the back of the instrument.

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 1 Introduction

External paper roll with removable, axial brackets

1 Power switch ON I, OFF 0

Fuse holder

Paper ejection slot / Printer

Display 2 lines, 20 characters each. The display is

refreshed every minute to avoid that incorrect data will
be displayed.

Membrane keypad with keys 0 - 9, Cal,

Enter, ESC, <--, -->

1 2 3 Cal
< >
4 5 6 Incubation block 37 °C: The incubation block is
Esc
7 8 9 0
Enter
temperature-controlled by the software after the instru-
ment has been switched on.
- 3 x 10 positions for cuvettes

- T = Position for temperature determination

T
- 4 positions for reagent bottles, left position with
magnetic stir function

- 2 measuring channels with light protection cap for

Eppendorf pipette tips.
Incub Incub Both measuring channels are equipped with speed-
controlled stirrer motors.
Reset Start Reset Start - Membrane keypad for function keys for test
processing.

Figure 1 Overview functions of BFT* II

NOTE
The light protection caps have been specially constructed for Eppendorf
pipette tips. Ordering information for pipette tips that have been approved
for use on the BFT* II can be found in the current BFT* II Reference
Guide.

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 1 Introduction

BFT* II type plate (located on the underside of the instrument)

it contains:
- the type 1
- serial number / date of production
- voltage and fuses
- technical specifications
- manufacturer and distributor

Made in Germany

Type: BFT* II Analyzer

SN X 00 0 0000

Input: 90 - 264V 50/60Hz 145VA Fuse: 1,6AT IVD

Dade Behring Marburg GmbH
35041 Marburg, Germany

Figure 2 Example for BFT* II type plate

Key Description

1 2 3 Cal
< >
4 5 6
Esc Enter
7 8 9 0

Figure 3 Membrane Keypad Calculator

Enter - Confirm selection, printer paper advance

Cal - Calibration
Menu selection, Instrument setting and method parameter,
function to save data that has been entered.

Esc - Switch from measuring mode into STANDBY.

Cancel entries.
0 - Parameter print-out only during measuring mode
0-9 - for parameter entries.

< - Selection according to display, backwards.

>. - Selection according to display, forward, set decimal point.
- both arrow keys can be used for setting characters with the type
generator.

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 1 Introduction

1 Incub Incub

Reset Start Reset Start

Figure 4 Membrane Keypad at Measuring Channels

Incub. = Incubation:
Incub. - Start of sample incubation timer with respect to measuring
channel.

Reset - Cancel current measurement. Display: break

Start - Manual test start - measurement stop - result conversion - next

conversion - result printout.

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 1 Introduction

1.3 Installation
Remove BFT* II from its packaging and verify that the accessories kit is
complete. Please notify Dade Behring Service immediately in the event that 1
the shipment was incomplete. Refer to Chapter 6.4 for more details.

To install the BFT* II proceed as follows:

• Prior to installation of the analyzer, read the instructions in chapter 6.1

Hazards and Precautions.

• Position the BFT* II so that it is not exposed to excess humidity, any

explosive gases, or magnetic influences.

• Connect the power cable between the BFT* II and a power supply free
from interferences by large power users such as elevators and
centrifuges.

NOTE
Outside the US the BFT* II are delivered without main cables. The main
cables used must meet the local regulations (e.g. VDE, CSA-C22.2, No
21 and No 49). The cable has to be designed with NYLHY. The recom-
mended length is 1.5 m, and the minimum cross-section is 3 x 0.75 mm2.
A cold device plug is used at the BFT* II end.

Switch ON/OFF
• Turn on the BFT* II by switching the power supply switch to position I.
Refer to Figure 5.

• Use only original cuvettes and stir bars which will assure proper operation
of the instrument. Stir bars are mandatory for correct measurements.
Fuse housing

Main switch
230 V

Figure 5 BFT* II Rear of Instrument

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 1 Introduction

1.4 Measuring Principle

1 The BFT* II operates according to the opto- mechanical measuring
principle. This measuring principle is especially suited for lipemic and/or
icteric or colored samples as well as reagents with kaolin.
A light beam passes through the cuvette containing the test plasma onto a
photodetector. Any change in the intensity of the transmitted light, that is
light increase or decrease, is converted into an electric signal.

The period from adding the starting reagent until clot formation is observed.
It then can be converted into the appropriate units (%, INR, mg/dl, g/l).

Once the start reagent has been added the measuring channel is
repeatedly adjusted, that is the lamp intensity automatically adjusts up or
down depending on the turbidity of the test sample. In this process the tur-
bidity of the sample plasma and the reagent are adjusted for.

A stir bar is located in each cuvette. During the measuring process the stir
bar provides homogeneity of the reagent-plasma medium. At the same time
a small whirl emerges through the stir bar movement which assures that
even the smallest fibrin clot is formed in front of the photodetector.

This stirring action combined with the optical measurement constitute the
basic features of the patented "turbodensitometric measuring principle".

test cuvette

Lamp Detector

permanent magnet

stirrer motor

ELECTRONICS
DISPLAY

Figure 6 Measuring Principle

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 1 Introduction

1.5 Reagents
Various assays to determine PT, APTT, many factors1, etc. are available
from Dade Behring Service. 1
Informations about the Application Sheets of the reagents can be found in
the current BFT* II Reference Guide.

Contamination
When different reagents are applied and especially reagents containing
thrombin, the danger exists that reagents are spread.
When the reagent is added, the light protection cap will be moistened with
reagent and therefore constitutes a point of contamination.

CAUTION After each method change, this contamination point must be cleaned
with an appropriate thrombin inactivator (Washing Solution
for Coagulation Analyzers) and a cotton bud.

Additional requirements and

recommendations

NOTE
- Use a pipette that is regularly checked.

- Use a tip that properly fits onto the pipette and has been approved for
use on the BFT* II.

- Avoid air bubbles when pipetting.

- Prior to the use of reagents, read the Application Sheets and follow the
instructions.

- Only use cuvettes and stir bars from the original manufacturer. These
cuvettes are subject to strict quality control. Cuvettes and mixers are
for single use only!

- Perform an analytical quality control on a regular basis.

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 2 Operation

2 Operation

2.1 Operating Steps

Communication with the BFT* II is performed via the Liquid Crystal Display.
At this point the user should be familiar with the key functions introduced in
chapter 1.2. 2
Bullets
A bullet • draws your attention to an instruction.
Example: • Press Enter-key to confirm selection.

User qualification

CAUTION It is absolutely necessary that only skilled personnel will access the
parameter menu with a secret number as improper handling of the
BFT* II might cause inaccurate measuring results. (see chapter 3.2.4
<secret number>)

All settings in the parameter menu must be done in accordance with

Dade Behring requirements. Upon alteration a parameter protocol must
be printed in order to check all settings again.

2.1.1 Switch on BFT* II

NOTE

Before switching on the instrument, remove the dust cover.

The instrument must never be operated with the dust cover on.

• Set the power switch to position I.

The following information will appear in a flow display:

reading parameters
from internal

BFT II V 02.02. floating text

Display of instrument name, program version number, and manufacturer.

*** Selftest *** memory test

ROM: OK RAM: OK

Should the message ERROR appear, you must contact Dade Behring
Service to have the fatal error corrected.

Then you will be asked if printer paper has been inserted.

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 2 Operation

Printerpaper Esc: NO
inserted? Enter:Yes

2 Has enough paper been installed?

If YES,
• press the Enter-key, the paper will advance 5 lines and the printer will
stay on.
If NO, press the Esc-key, the printer will be off.

The printer can be activated by ...

- set to ON in the menu UTILITIES
- restart of BFT* II with enough paper in the printer.

Change Paper
To change printer paper refer to chapter 2.2 Change Paper.

The BFT* II requires approximately 30 min. to warm up the heating block to

an operating temperature of 37.4 °C (deg). The current temperature of the
heating block is displayed in the upper right hand corner of the display. The
lower line shows the current method with its memory number.

WARM UP 35.6 deg start WARM UP

< 1 PT > Memory position 1: PT

WARM UP 15:00 timer will display the last

< 1 PT > 15 min. to release BFT* II

The last 15 min. of the warm up phase will be supported with a timer count
down. After count down the BFT* II is ready for operation.

NOTE

Use the warm-up phase to load the BFT* II cuvettes and reagents for
the tests that will be performed. Each cuvette must contain a stir bar.
Follow the instructions by the reagent manufacturer. Verify the method
parameters with those that have been saved to the BFT* II.
For your own safety follow the instructions with respect to hygiene.

Once the operating temperature has been reached, the following request
will appear:

remove all cuvettes

then press any key

• Remove any existing cuvettes from the measuring channels.

• Press any key (e.g. Enter) to confirm the operation.

In the following display the measuring channels for automatic cuvette

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 2 Operation

recognition will be adjusted (self-adjustment).

auto blanking
keep channels clear
2
The STANDBY mode will be displayed automatically.

STANDBY 37.4 deg

< PT >

The method selected last prior to restarting the analyzer, such as PT, is
displayed.

If you want to start with analytics, press the Enter-key to change to the
measurement mode (see chapter 2.1.3 Measurement).

Printer
If the printer is set to ON in the menu UTILITIES the current parameter
status will be printed out after the first measurement has been performed
and the Start-key has been pressed for conversion of the result.

The results from the left channel will be printed left justified and the results
from the right channel will be printed right justified.

Press the Enter-key for line feed. For more information and change of
paper refer to chapter 2.2 Measuring.

2.1.2 STANDBY Mode

In STANDBY-mode you can
- use the arrow-keys to select a method
- change to measuring mode
- access the parameter menu for the method on the display.

STANDBY 37.4 deg

<1 PT >

The temperature of the heating block and the selected method are
displayed.

Change to STANDBY Mode

• Press the Reset-key after a measurement. The request Incubat/cuv in or
Incubat/cuv out will appear on the display.

• Press the Esc-key to access the STANDBY mode.

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 2 Operation

Change to Operation Mode

• Press Enter. The request for sample incubation will be displayed.

incubat. incubat.
2 cuv in cuv in

2.1.3 Measuring
Both measuring channels can only operate in one selected method as for
example PT. It is not possible to select a method for a specific measuring
channel.

Cuvettes and reagents can be placed in the incubation block for one spe-
cific measuring channel.

The function keys Incub, Reset, and Start which are used to address the
measuring channels, are located to the side of the measuring channel.

Single determination
For all defined tests you can do single determination tests. A mean value
calculation from two single values is not supported by the software.

Sample incubation
• Pipette a plasma sample without air bubbles in a cuvette that has been
prewarmed in the Incubation block to 37 °C.

• Press the Incub-key; the incubation time as selected in the setup will run
and begins counting down. At 5 sec. remaining incubation time a signal is
heard.

NOTE

If a result is displayed during an incubation the result will be marked with

a flashing asterisk "*".

For methods you can enter a second sample incubation phase. See
chapter 3.1.5.1. By the display of incubat 1 and incubat 2 the incubation
phases will be shown.

Follow the same procedure for the other measuring channel.

5 s incubat.
cuv in cuv in

• Push light protection cap back.

• Once the incubation has been completed a long beep can be heard, then
place the cuvette in the appropriate measuring channel. Please make
sure that knob in cuvette fits into notch in measuring channel. Close light

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 2 Operation

protection cap to avoid outside light penetration.

NOTE

If the cuvette has not been inserted into the measuring channel and
liquid is inadvertently pipetted on the red tongue of the light protection
cap, the cap should be removed by unscrewing the two front screws
2
from the thermoblock.

To clean the light protection cap, move the slider of the cap back and
forth to allow the liquid collected for protection to drain from the red
tongue. Then, disinfect the light protection cap, rinse it with distilled
water and let it dry.
After cleaning, fasten the light protection cap back on the thermoblock
by tightening both screws evenly. Ensure that the light protection caps
are aligned correctly.

CAUTION When cleaning the light protection cap, do not push the red tongue too
far back inside the cap, otherwise, the spring with the red tongue may
come off.

Figure 7 Assembly/disassembly of the light protection cap

The BFT* II will automatically recognize the placement of a cuvette.

A turbidity adjustment of the sample will be performed. Next the pipetting of

100 µl starting reagent to start the measurement will be requested with GO
100 ul (example).

incubat. incubat. Example:

GO 100 ul GO 100 ul 100 ul = 100 µl

• Pipette the requested quantity of 100 µl starting reagent through

the opening of the light protection cap vertically into the measuring
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 2 Operation

cuvette.

Due to the change in turbidity the measuring process will be started auto-
matically.

2 As soon as the clot formation has been recognized the measuring timer
displays the measured clotting time.

incubat. incubat.
t= 12.4 s t= 11.8 s

If conversions have been programmed for the selected method, these

conversions can be displayed.

• Press the Start-key to display %

% %
93.0 101.1

The results will be printed out automatically. Measuring time, errors and all
conversions will be printed out. An identification can be entered manually
under Patient: _______

Sequential numbers will be assigned in the order of print-outs and not in the
order of started measurements.

• Press the Start-key for the display of INR.

INR INR
1.05 0.98

• Press the Start-key for the display of time.

time time
12.4 s 11.8 s

• Press the Reset-key to clear the memory for the next measurement.

incubat. incubat.
cuv out cuv out

• Remove the cuvettes from the measuring channels.

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Continue as described above.

NOTE

The measuring timer can be started or stopped manually by pressing

the Start-key.
This function is only possible after adjust- and lag-time.
Advantage: next measurement can start at once.
2
2.1.4 Change Method
A method can only be changed from the STANDBY mode.

STANDBY 37.4 deg

< 1 PT >

• Press the Esc-key in order to change to STANDBY.

You can select a method from the method list by pressing the:

- arrow key right, to select a method with a higher memory number.

- arrow key left, to select a method with a lower memory number.

Following methods can be selected with their memory numbers:

<1 PT >
<2 APTT >
<3 Thrombin Time1 >
<4 Batroxobin Time1 >
<5 Fib. g/l >
<6 Fib. mg/dl >
<7 Extr. Factor1 >
<8 Intr. Factor1 >
<9 PT-Innovin >
< 10 ProC G PCAT1 >
< 11 ProC G PCAT/01 >
< 12 ProC FV PCAT1 >
< 13 ProC FV PCAT/01 >
< 14 none >
< 15 none >
< UTILITIES >

• Select the desired method.

• Press Enter to activate the method selection.

writing parameters
to internal

The newly selected method has been initialized. Incubation for the first
measurements can be performed.

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 2 Operation

incubat. incubat.
cuv in cuv in

2 Continue as previously described.

<none>
The method memory positions 14 and 15 -none- are free positions where
new methods can be entered manually or installed and modified by copying
existing methods.
See chapter 3.1 Method Parameter.

UTILITIES
The menu UTILITIES is not a method but a group of menus. As soon as a
secret number. has been entered, selected global settings can be accessed
more quickly.

The sub-menus are as follows: <printer>, <beeper>,

< reagent-stirrer >, <secret number>, and <cuvette test>.

Refer to chapter 3.2 Utilities.

2.2 Change Paper

The paper roll is held by brackets on either side. To add a new roll of paper,
proceed as follows:

- Set the BFT* II to measuring.

incubat incubat
cuv in cuv in

• Remove the old paper tube by slightly bending the brackets to the outside.

• Add the new paper roll. Make sure that the paper roll fits properly onto the
brackets and that the paper can be inserted into the printer paper channel
below.

• Cut the end of the paper with scissors and do not tear! Then guide the
paper into the printer paper channel until you feel some resistance.

• Press the Enter-key several times to advance the paper.

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 3 BFT* II Parametrization

3 BFT* II Parametrization

3.1 Method Parameter

Method parameters in the BFT* II are preset by the manufacturer. You will
find an overview of the BFT* II Software and the preset parameters
in chapter 5.1 Software Overview.

The accessible method parameters are only for the selected method in
STANDBY. 3
The Secret number is necessary to access the method
parameters.

User qualification

CAUTION Operation of the BFT* II by unskilled personnel might cause incorrect

measuring results. Therefore, it is absolutely necessary that
skilled personnel only will have access to parametrization via the secret
number (see chapter 3.2.4 Menu <secret number>)

All parameter settings must be in accordance with Dade Behring. After

each entry a parameter protocol must be printed in order to check the
entry again.

Please remember that you will be responsible for quality control

and validation of all tests not supplied by Dade Behring.
Dade Behring does not ensure warranty for these tests.

Direct parameter access

Only the following parameters can be accessed from Standby/incubation
(cuv in) directly without entering the secret number:

- 1st conversion/calibration curve

- 2nd conversion (Ratio/ISI)
- reagent lot no.

The activated kind of conversion (<reference curve>, <quick with factor>,

<INR>) will be shown.

How can I access this menu?

• Change to STANDBY.
• Select the desired method.
• Press the Cal-key.
• Enter the secret number to access the method parameter menu.

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 3 BFT* II Parametrization

STANDBY 37.4 deg

<1 PT >

Cal
Enter >

Method parameter Test run Method list

secret no.: Cal
incubat incubat STANDBY 37.4 deg
.....

3
cuv in cuv in <1 PT >

Direct access to special parameter

1) method parameter STANDBY 37.4 deg
< general > <2 aPTT >

1) method parameter STANDBY 37.4 deg

< 1st conversion > < 3 Thrombin Time > 1

1) method parameter STANDBY 37.4 deg

< 4 Batroxobin Time > 1
< 2nd conversion >

1) method parameter
< measurement >

Figure 8 Direct Parameter Access

Method parameter groups

The parameters of each method memory position are grouped together.
The groups are: <general>, <1st conversion>, <2nd conversion>
and <measurement>.

Menu <general>
1) method parameter method parameter group
< general> selection

In this menu you can

<methodname> enter the name of the method
<load preset> load a preset method
<copy method> copy a preset method
<exchange methods> exchange the method memory positions
<delete method> delete a method

To optimize the BFT* II to your special requirements, you can

- change a method name. Follow the instructions as per chapter 3.1.1.1

Define Method Name.

- load a preset method from a memory position. Follow the instructions as

per chapter 3.1.1.2 Load Preset Method.

- copy a method. Follow the instructions as per chapter 3.1.1.3 Copy

Method.

- exchange memory positions of one method with another.

Follow the instructions as per chapter 3.1.1.4 Exchange Method Place.

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- delete a method. Follow the instructions as per chapter 3.1.1.5 Delete

Method.

Menu <1st conversion>

1) method parameter
< 1st conversion>

In this menu you can enter:

<reference curve> a 9-point calibration curve
3
<quick with factor> calibration curve with gradient
<none> no conversion

To change or verify parameters refer to chapter 3.1.2 Menu

<1st conversion>.

Menu <2nd conversion>

1) method parameter
< 2nd conversion>

In this menu you can enter:

<INR> ISI factor

<none> no conversion

To change or verify parameters refer to chapter 3.1.3 Menu <2nd conver-

sion>.

Menu <measurement>

CAUTION Parameters in this menu marked with an number symbol "#" may be
changed in accordance with Dade Behring only!

1) method parameter
< measurement>

In this menu you can enter:

- volume of starting reagent#, Lot number
- 1st- and 2nd incubation time#
- start number of print-out
- starting speed# and final speed# of the stirrer transition period# between
starting and final speed
- min value# minimum value (Digits) before clotting
- adjustment time#, learning time#, lag time#

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To change or verify parameters refer to chapter 3.1.4 Menu <measure-

ment>.

Save parameters
After finishing parametrization following display appears:

3 1) checking parameters
please wait

At the end of parametrization "checking parameters - please wait" is dis-

played automatically to check whether parameters have been changed. The
following display will appear:

- "parameters are unchanged" if no difference could be found.

- "save new parameters" if parameters have been changed.

save new parameters?

ENTER= yes, ESC= no

You can either select ENTER = yes or ESC= no. Press the Enter-key to
save the new parameters or press the Esc-key to keep the
former parameters. In both cases a higher menu level can be accessed.

3.1.1 Menu <general>

3.1.1.1 Define Method Name

The method name and the conversion unit for the method displayed in
STANDBY can be edited with the character generator.

The character generator has the following characters:

! " § $ % & /= ? + * # < > , . : _ A B C D E F G H I J K L M N O P Q R S T U
VWXYZabcdefghijklmnopqrstuvwxyz

The digits 0...9 must be entered by the number keys.

For a method name up to 15 characters can be entered of which the first 14

characters can be edited. The 15th character is empty if a method parame-
ter has been loaded from the preset memory position, e.g. after delivery of
the BFT* II from the manufacturer, or if it is identical to the preset parame-
ters.
The 15th character will automatically become a point if a parameter
influencing the clotting time has been changed and is no longer identical to
preset parameters. Thus, the preset parameters can be differentiated from
an edited version in the print-out protocol.

See chapter 3.1.4 Menu <measurement> for a list of parameters possibly

influencing the clotting time.

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In general it is possible to enter new method parameters. However, this is

rather time-consuming.
We recommend to load a preset method similar to the desired method and
edit it with <change parameter>.
• Select <general>

1)method parameter
< general >
3
• Press the Enter-key to confirm.
• Select <methodname> in menu general.

1) general
< methodname >

• Press the Enter-key to confirm selection.

1) methodname:
PT >

The cursor marks the first position of the method name.

To write the method name use:

- the arrow-key right/left to set the desired character.

- the Enter-key to change the character position.

NOTE
If you keep the arrow-key pressed the characters will be displayed
faster and you can speed up your selection.

If you keep the Enter-key pressed the cursor will move faster.

• Follow the instructions to enter the method name.

When the last character has been entered

• press the Enter-key several times until the cursor has reached the final
position.

1) methodname:
PT .

• Press the Enter-key to confirm the method name.

Delete character
Use the Esc-key to set a blank character. The cursor will go forward one
step.

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3.1.1.2 Load Preset Method

The method memory positions 1-13 of the BFT* II have been preset com-
pletely by the manufacturer. In chapter 5 Software you will find an overview
of the preset methods. These parameters are saved in the preset (ROM) of
the BFT* II and can be reloaded.

Follow the instructions below to load a method from the preset to a method
memory position. For example, method <6 Fibr. mg/dl> shall be loaded to

3
method memory position <14 none>

• Select <14 none> in STANDBY mode.

• Press the Cal-key to access the parameter menu after having entered the
secret number.

The message writing parameters to internal appears for a while then

menu <general> appears.

• Press the Enter-key to confirm selection.

• Select the function <load preset> in the <general> menu.

14) general
< load preset >

• Press the Enter-key to confirm selection. The following display appears:

14) load preset:

< 14 none >

• Press the arrow-key to select the desired method

<6 Fibr. mg/dl>).

14) load preset:

< 6 Fibr. mg/dl>

• Press the Enter-key to confirm the selection. The following display

appears:

14) overwrite?
ENTER: Yes,Esc: No

• Press the Enter-key to save the desired method or press the Esc-key to
leave the menu without saving. With overwrite the new parameters will
be saved.

Automatically the next menu will be displayed:

14 general
< copy method>

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Since the complete method including calibration curve parameter was

saved all parameters for the reagent lot must be updated.

• Press the Esc-key to reach the upper menu to change parameter under
<1st- or 2nd conversion> or <measurement>.

• Press the Cal-key to reach the STANDBY-mode.

The message "checking parameters please wait" appears:

3
save new parameters?
ENTER=Yes,Esc= No

• Press the Enter-key to save parameters or press Esc to

leave the menu without saving.

3.1.1.3 Copy Method

If you want to install a method which is rather similar to an
existing method you can copy it to the desired method memory position and
modify the parameters where necessary.

Follow the instructions below to copy an existing method to a

method memory position. For example, method <2 APTT> shall be loaded
to method memory position <14 none>:

• When in STANDBY mode select the method memory position (14 none).

• Press the Cal-key to access the parameter menu after having entered the
secret number.

• Select the function <copy method> in the <general> menu.

14) copy from:

< 14 none >

• Press the arrow-key several times to select the desired

method <2 APTT>.

14) copy from:

< 2 APTT >

• Press the Enter-key to confirm the selection. The following display

appears:

14) overwrite?
ENTER= Yes,Esc= No

• Press the Enter-key to save the desired method or press the Esc-key to
leave the menu without saving. With overwrite the new parameters will
be saved.
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Automatically the next menu will be displayed.

14 general
<exchange method>

• Press the Esc-key to reach the upper menu.

3 • Press the Cal-key to reach the STANDBY.

At last the software will check if parameters have changed (checking

parameters).

save new parameters?

ENTER=yes,Esc=no

• Press the Enter-key to save parameters or press Esc to leave the menu
without saving.

3.1.1.4 Exchange Method Place

Sometimes it might be useful to exchange method memory positions.

Follow the instructions below to exchange two method memory positions.

For example, the method on position <3 Thrombin time>1 shall be
exchanged with method <9 PT-Innovin>:

• When in STANDBY mode select the method memory position <3 Throm-
bin Time>1.

• Press the Cal-key to access the parameter menu after having entered the
secret number.

• Select the function <exchange method> in the <general> menu.

3) exchange with:
< 3 Thrombin Time >1

• Press the arrow-key several times to select the desired method <9 PT-
Innovin>1.

3) exchange with:
< 9 PT-Innovin >

• Press the Enter-key to confirm the selection. The following display

appears:

3) exchange?
ENTER: Yes,Esc: No

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• Press the Enter-key to save the desired method or press the Esc-key to
leave the menu without saving.

No parameters will be deleted when exchanging the method memory

positions.

Automatically the next menu will be displayed.

14 general
3
< delete method>

• Press the Esc-key to reach the upper menu.

• Press the Cal-key to reach the STANDBY.

At last the software will check if parameters have changed

(checking parameters).

save new parameters?

ENTER=yes,Esc=no

• Press the Enter-key to save parameters or press Esc to leave the menu
without saving.

3.1.1.5 Delete Method

In order to delete a method memory position follow the
instructions below:

• When in STANDBY mode select the method memory position to be

deleted.

• Press the Cal-key to access the parameter menu after having entered the
secret number.

• Select the function <delete method> in the <general> menu.

x) delete method?
ENTER: Yes,Esc: No

• Press the Enter-key to delete the method memory position or press the
Esc-key to leave the menu without deleting.

Automatically the next menu will be displayed.

14 general
< methodname>

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 3 BFT* II Parametrization

After deletion of method in memory position 14 the method

menu will show < none >

• Press the Esc-key to reach the upper menu.

• Press the Cal-key to reach the STANDBY.

At last the software will check if parameters have changed

(checking parameters).

3
save new parameters?
ENTER=yes,Esc=no

• Press the Enter-key to save parameters or press Esc to leave the menu
without saving.

3.1.2 Menu <1st conversion>

You have two options to do the <1st conversion>:

- press the Cal-key from STANDBY-mode of a method and enter the secret
number.

- press the Cal-key from "incubat/cuv in" directly without entering the secret
number.

You can select one of the following options:

Display Meaning
<reference curve> entering a 9-point reference curve
<rising>/<falling> rising or falling reference curve
<unit> unit of reference curve to be edited by the
text generator
<decimal place> number of digits after decimal point (format
xxx.x)
<min/max value> ranges of activity/concentration
<time interpolation> linear - reciprocal- logarithmic
<value interpolation> linear - reciprocal- logarithmic
<quick with factor> reference value and factor of curve gradi-
ent
<none> no conversion

See chapter 3.1.5.1 PT Parameter

NOTE

If complete data have been entered under <reference curve> and

<quick with factor> the reference curve entered last will be active for the
conversions in the measuring mode.

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3.1.3 Menu <2nd conversion>

You have two options to do the <2nd conversion>:

- press the Cal-key from STANDBY-mode of a method and enter the secret
number.
- press the Cal-key from "incubat/cuv in" directly without entering the secret
number.

In this menu you can enter a 2nd conversion by selecting

<INR>: 3
- INR by entering the ISI value additionally
- <none> for no conversion

NOTE

If <none> has been selected under first conversion an input field for the
reference value will be displayed automatically for the INR conversion
under <2nd conversion>

See chapter 3.1.5.1 PT Parameter

3.1.4 Menu <measurement>

In general, inputs in the <measurement> menu can be done only from
STANDBY mode of a method by pressing the Cal-key and entering the
secret number.
Exception:
Only the reagent lot number can be accessed from incubation mode
<incubat/cuv in> of a method directly by pressing the Cal-key without enter-
ing the secret number.

CAUTION All parameters marked with an number symbol "#" except the reagent lot
number may be modified only after consultation with Dade Behring.
Any modification will cause different measuring times.

The following parameters influence the measuring times:

Selection meaning
<mixer> stirrer starting speed - period of reduction until
final speed is reached - stirrer final speed
<min value> minimum measuring value in digits before clotting
<adjust> adjustment time / learning time / lag time
<time interpolat> evaluation reciprocal - linear - logarithmic
<incubation> first and second incubation time
<Start Reag> volume of starting reagent
<methodname> connection with parameters if the method-name
changed

The following selection can be accessed:

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Selection Meaning

x) Start reag 100 # Enter: starting reagent volume

lot no. 505719 (µl)
Enter: reagent lot number

x) incubat (0= off) Sample incubation time (sec)

3 1st=0 s#, 2nd=60 s# 0 s = no incubation/display
1st = 1. incubation time (sec)
2nd = 2. incubation time (sec)

x) printout number Starting number for serial

start-no. xx1 print-out
Enter a xxx digit number

x) mixer: xxx s# period of reduction until final

xxx rpm #xxx rpm # speed is reached, starting
speed (sec)
Starting revolutions / final
revolutions

x) min value: constant factor

xxx digits#

x) adjust: xx s# adjustment time after starting

learn:xx s#, lag: xx s# learning time / lag time (sec)

For further information see chapter 3.1.5.1 PT Parameter.

3.1.5 Method Configuration

In the following the parametrization of a preset method will be explained.

3.1.5.1 PT Parameter
Method parameters in the BFT* II are preset by the manufacturer. Before
you start with your analysis the method parameters must be updated for the
respective reagent.

• Set BFT* II to STANDBY.

STANDBY 37.4 deg

< 1 PT>

• Press the Cal-key; the system will request an up to 5-digit secret no. (No.

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 3 BFT* II Parametrization

from manufacturer: 11111) (For further information refer to chapter 3.2.4

Menu <secret number>)

secret no.:
_ _ _ _ _

3
The following display will appear, provided the correct secret number was
entered:

1) method parameter
< general >

If the number was incorrect the previous display appears.

When pressing the arrow-key --> the menus <general>

<1st conversion>, <2nd conversion>, <measurement> will be displayed in
this group of menus.

<1st conversion>
• Select the 1st conversion
• Press Enter; the following display appears:

1) 1st conversion
< reference curve >

If no reference curve is to be entered, press the arrow-key -->. <none> will

be displayed. As soon as the Enter-key has been pressed, the selection will
be confirmed.

<reference curve>
• Press Enter; the following display appears:

rising/falling

1) reference curve:#
< falling >

You can select a falling reference curve. If a rising reference curve is

desired, press the arrow key to select <rising>.

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 3 BFT* II Parametrization

% %

time time
rising falling
3 Figure 9 Curve rising / falling

Calibration curves must be entered in such a way that you start with the
highest % values and shortest measuring times in seconds for falling
curves (coagulation factors). For rising curves (inhibitors or INR-Cal) you
have to start with the lowest % / INR values and the longest measuring
times in seconds. The software will support this procedure only.

• Press the Enter-key to confirm <falling>. The following display to enter

the unit appears.

unit

1) unit: max. charact. format:

%____ (mg/dl) for example

Each conversion unit can be composed of 5 characters.

As described in chapter 3.1.1.1 Define Method Name the character genera-

tor is used for the input. The fraction bar is fixed.

• Select the characters for the unit and confirm them by pressing the
Enter-key.

decimal place
The display to enter the digits (decimal place:) appears:

1) decimal place:
< format xxx.x >

There are 4 alternatives

<format xxx.x> or <format xx.xx> or <format x.xxx> or
< format xxxx. >

• Select the format desired and press the Enter-key to confirm.

conversion limits
You can enter the minimum and maximum values for the calibration curve
and conversion now:

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 3 BFT* II Parametrization

1) min/max value:
5.0 /150.0 %

NOTE
Use extrapolated sample results only if accepted by local authorities.
3
An error message appears if the values are outside the ranges. These
parameters show the number of digits after the decimal point and the unit.

• Type in minimum value and maximum value and confirm setting

by pressing the Enter-key.

calibration points
A 9-point reference curve can be entered with this menu.
Points on the reference curve that are not to be used, must have the entries
0.0 % and 0.0 s. A minimum of 2 points must be defined. We recommened
to define at least 3 points. Before you leave this menu, enter all calibration
points to control or change the settings. All following calibration points are
for example.

1) 1. point:
97.0 % 11.5 s

• Confirm an activity of 97.0 % by pressing the Enter-key, or overwrite the

previous information by pressing the appropriate number keys. The entry
will be confirmed by pressing Enter. The cursor changes to a time setting.

• Enter the clotting time for the respective activity of 97.0 %.

• Press Enter to confirm the entry.

The field for the next point on the reference curve appears.

1) 2.point:
43.0 % 20.1 s

• Verify or update the second calibration point as previously described.

• Proceed as described above to enter the remaining calibration points.

interpolation
As soon as the last point on the reference curve has been confirmed
the following display will appear:

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 3 BFT* II Parametrization

#
1) time interpolat.
< linear >

For the interpolation of the time axis the following options can be selected:
<linear> <reciprocal> <logarithmic>.

3 • Select <linear> and press the Enter-key to confirm.

In the following display you can select interpolation modes for the activity/
concentration: <linear><reciprocal><logarithmic>.

1) value interpolat#
< reciprocal >

For example, select <reciprocal> and

• press the Enter-key to confirm.

Following display appears:

select:ESC= work
ENTER= more param.

• Press the Esc-key to access measuring or press Enter to set or verify

more parameters.

<quick with factor>

By entering the 100%-time value and the factor for the slope of
the reference curve, the PT-reference curve can be entered.
• Press the Enter-key to confirm selection.

conversion limits
You can enter the minimum and maximum values for the
calibration curve and conversion now:

1) min/max value:
5.0 / 150.0 %

NOTE

Use extrapolated sample results only if accepted by local authorities.

An error message will be displayed if the values are outside the range.

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These parameters show the number of digits after the decimal point and the
unit as described under < reference curve >.

• Enter the conversion limits and press the Enter-key to confirm.

The following display appears:

reference value/factor

1) 100% = 12.0 s Example

3
factor= 54

The value factor is currently not supported for the BFT* II.
The factor has two digits. Internally the value will be multiplied by 10 (see
6.8 Mathematics).

NOTE
If complete entries have been made for <reference curve> and <quick
with factor>, the type of reference curve selected last will be active for
the conversions in the measuring mode.

<none>
No conversion under 1st conversion.

<2nd conversion>
Following menus can be selected if <reference curve>, <quick with factor>
or <none> was selected under 1st conversion:

- <INR> for INR conversion

- <none> for no conversion.

Only the last selection under 2nd conversion is active for 2nd conversion.

1) method parameters
< 2nd conversion >

<INR>
• Press Enter; the following display will appear:

1) 2nd conversion
< INR >

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If a reference curve has been entered under <1st conversion> in menu

<reference curve> or <quick with factor> the 100% time value will be used
for the evaluation of INR.

If under <1st conversion> <none> is selected for no conversion the

following display will appear to enter the 100% value.

• Press Enter to confirm selection.

3
1) 100% = 11.8 s Example

• Press Enter to enter the ISI-value.

1) ISI= 1.09 Example

• Enter the ISI-value for the respective reagent as indicated on the table of
values.

• Press Enter to confirm the entry.

select:ESC= work
ENTER= more param.

• Press the Esc-key to access measuring or press Enter to enter or verify

more parameters.

<none>
No conversion under 2nd conversion.

<measurement>

1) method parameter
< measurement >

• Press the Enter-key. The next display appears:

Reagent volume / lot no.

1) Start reag 100# ul

lot.no. 505714

• Enter the volume for the starting reagent, for example 100 µl.
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 3 BFT* II Parametrization

• Press Enter to confirm the entry.

• Enter the reagent lot number.
• Press Enter to confirm the entry.

The next display will appear:

Incubation time

3
1) incubat. (0=off) 0= no incubation
1st= 0 s# 2nd= 60 s# max.: 600 s

• Enter the appropriate 1st. sample incubation time for 1st=xxx s and
2nd=xxx s.

1st incubat. 2nd incubat. Display

0s 0s no incubation
>0 s 0s incubation
0s >0 s incubation
>0 s >0 s 1st + 2nd incubation

• Press the Enter-key to confirm the entry.

The next display will appear:

Print-out number

1) printout number maximum: 3 characters

start-no.1

• Press the Enter-key to confirm.

• Enter the starting number for print-out numbering, for example: 1.

• Press the Enter-key to confirm setting.

The next display will appear:

mixer function

1) mixer: 40 s# Time: speed reduction

Start/end speed
500 rpm# --> 250 rpm#

• Enter the time (sec) of speed reduction to end speed in seconds.

• Enter the starting speed (200 - 500 rpm).
• Enter the end speed (200 - 500 rpm).

As explained the measurement will start with 500 rpm mixer revolutions.

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 3 BFT* II Parametrization

The final revolutions of 250 rpm will be reached after 40 seconds until the
clot has been found. Thus the sample will be blended well and even
unstable clots will be detected.

• Press the Enter-key to confirm. The next display appears.

min value

3 1) min value:
150 digits#

Here a constant factor depending on the method can be

entered. Before modification consult Dade Behring!

• Press the Enter-key to confirm. The next display will appear:

adjust/ learn- / lag time

1) adjust: 1 s #
learn: 3 s#,lag: 1 s #

Here you can enter parameters for the optical detection of the sample.
Before modification consult Dade Behring.

• Press the Enter-key to confirm. The next display will appear:

select:Esc= work
ENTER= more param.

• Press the Esc-key to access measuring.

checking parameters
please wait

If parameters changed the following display appears:

save new parameters?

ENTER=yes,ESC=no

• Press the Enter-key to save parameters or press Esc to leave the menu

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 3 BFT* II Parametrization

without saving. The display changes to measuring.

You will be asked to perform a sample incubation.

incubat incubat
civ in cuv in

Continue as described.
3
3.1.5.2 APTT Parameter
Before you start with your analysis, the method parameters must be
updated for the respective reagent.

The preset method on the method memory position <2APTT> has the
same structure as the method described in 3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for APTT tests with Dade Behring reagents
have been preset.

3.1.5.3 Thrombin Time Parameter1

The preset method on the method memory position
<3 Thrombin Time>1 has the same structure as the method described in
3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for Thrombin Time1 tests with
Dade Behring reagents have been preset.

3.1.5.4 Batroxobin Time Parameter1

The preset method on the method memory position
<4 Batroxobin Time>1 has the same structure as the method described in
3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for Batroxobin Time1 tests with Dade Behring
reagents have been preset.

3.1.5.5 Fibr. g/l Parameter

The preset method on the method memory position
<5 Fibr.g/l> (Fibrinogen Test) has the same structure as the method
described in 3.1.5.1 PT Parameter.

Conversion parameters have been preset.

Reliable method parameters for Fibrinogen tests with Dade Behring
reagents have been preset.

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3.1.5.6 Fibr. mg/dl Parameter

The preset method on the method memory position
<6 Fibr. mg/dl> (Fibrinogen Test) has the same structure as the method
described in 3.1.5.1 PT Parameter.

Conversion parameters have been preset.

Reliable method parameters for Fibrinogen tests with Dade Behring
reagents have been preset.

3 3.1.5.7 Extr. Factor Parameter1

In this menu you can select a factor (Factor II1, Factor V1, Factor VII1, or
Factor X1).

The preset method on the method memory position <7 Extr. Factor>1 =
extrinsic factors = exogenous coagulation factors has the same structure as
the method described in 3.1.5.1 PT Parameter.

Conversion parameters have been preset.

Reliable method parameters for factors II, V, VII, X tests1 with Dade Behring
reagents have been preset.

3.1.5.8 Intr. Factor Parameter1

In this menu you can select a factor1 (Factor VIII, Factor IX, Factor XI, or
Factor XII).

The preset method on the method memory position <8 Intr. Factor> = intrin-
sic factors = endogenous coagulation factors has the same structure as the
method described in 3.1.5.1 PT Parameter.

Conversion parameters have been preset.

Reliable method parameters for factors VIII, IX, XI, XII tests1 with Dade
Behring reagents have been preset.

3.1.5.9 PT-Innovin Parameter

The preset method on the method memory position <9 PT-Innovin> has the
same structure as the method described in 3.1.5.1 PT Parameter.

Conversion parameters have been preset.

Reliable method parameters for PT with Dade Behring Innovin reagent have
been preset.

3.1.5.10 ProC G PCAT Parameter1

The preset method on the method memory position <10 ProC G PCAT>1
(Protein C activity dependent clotting time) has the same structure as the
method described in 3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for PC AT tests1 with Dade Behring reagents
have been preset.

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3.1.5.11 ProC G PCAT/0 Parameter1

The preset method on the method memory position <11 ProC G PCAT/0>1
(Protein C activity dependent clotting time - blank value) has the same
structure as the method described in 3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for PC AT/0 tests1 with Dade Behring reagents
have been preset.

3.1.5.12 ProC FV PCAT Parameter1

3
The preset method on the method memory position <12 ProC FV PCAT>1
(Factor V Leiden activity dependent clotting time) has the same structure
as the method described in 3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for ProC FV PC AT tests1 with Dade Behring
reagents have been preset.

3.1.5.13 ProC FV PCAT/0 Parameter1

The preset method on the method memory position <13 ProC FV PCAT/0>1
(Factor V Leiden activity dependent clotting time - blank value) has the
same structure as the method described in 3.1.5.1 PT Parameter.

Conversion parameters have not been preset.

Reliable method parameters for ProC FV PC AT/0 tests1 with Dade Behring
reagents have been preset.

3.1.5.14 none
The method memory position can be defined.

3.1.5.15 none
The method memory position can be defined.

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BFT* II Analyzer - Instruction Manual - Version 3.1 3 23

 3 BFT* II Parametrization

3.2 Utilities
The menu UTILITIES comprises a group of submenus which allow quick
access to the settings in the following menus:
<printer>, <beeper>, <reagent-stirrer>, <secret number > and
< cuvette test >.

• Select menu UTILITIES.

• Press the Cal-key to access the UTILITIES menu.

3 • Enter the appropriate secret no. The following menu appears:

Menu Overview Settings

< printer > ON - parameter protocol - OFF
< beeper > ON - OFF - CLICK
< reagent-stirrer> ON: 250 rpm, OFF: no stirring
< secret number > Input of individual secret number.
< cuvette test > Verification of automatic cuvette recognition.

After a selection has been made in one of the listed menus, the following
display will appear:

select:ESC= work
ENTER= more param.

Press Esc to access the measuring mode or press Enter to access more
menu options.

checking parameters
please wait

If parameters changed the following display appears:

save new parameters?

ENTER=yes,ESC=no

You have the choice to press the Enter-key to save parameters or press
Esc to leave the menu without saving. In both cases an upper menu
appears.

3.2.1 Menu <printer>

In this menu you can select between <ON>, <OFF>, and <parameter-proto-
col>.

To activate the printer, select ON

Printout of:
- Test results and conversions
- Method parameters
- General Parameter list and BFT* II serial number
(example: B1770711)

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3 24 BFT* II Analyzer - Instruction Manual - Version 3.1
 3 BFT* II Parametrization

- Error messages

To deactivate the printer, select OFF

To print-out all stored parameters for the documentation of settings select

parameter-protocol.
• The arrow keys are used to make a selection in the display.
• A selection is confirmed by pressing Enter.

3
3.2.2 Menu <beeper>
The beeper acoustically confirms the key functions and beeps in case of
error.
In this menu you can select between <ON>, <OFF>, and <CLICK>.

The beeper is activated by selecting ON. Each action is confirmed by the

beeper.

The beeper is deactivated by selecting OFF.

If CLICK is selected only keystrokes will be confirmed by the beeper.
• The arrow keys are used to make a selection in the display.
• A selection is confirmed by pressing Enter.

3.2.3 Menu <reagent-stirrer>

At the standard setting ON the stirring speed is 250 rpm in the reagent
position (see figure 1).
After selecting OFF there is no stirring function.

3.2.4 Menu <secret number>

This menu allows you to select a secret number up to 5 digits for access of
the parameter menu.

Numbers from 00001 to 65535 can be used.

After <secret number> has been selected, the following display appears:

enter new secret no.

>11111< (0=none)

The preset number by the manufacturer can be overwritten at this point.

- Press Enter to confirm the entry. A print out will follow (printer mode: ON).
-----------------------------------------------------------
BFT II
ser. no. B1770711 Example
secret no=xxxxx x= count
-----------------------------------------------------------

If a zero is entered and saved, the secret number will not be asked for when
selecting the parameter menu. It will be printed out as “secret no=00000“.

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BFT* II Analyzer - Instruction Manual - Version 3.1 3 25

 3 BFT* II Parametrization

3.2.5 Menu <cuvette test>

This menu checks the function of the automatic cuvette
recognition.

After <cuvette test> has been selected, the following display appears:

123/622 122/597
3 --- cuv

In case no cuvette was set in the measuring channel, a horizontal line

( ------ ) will be displayed.

If a cuvette was placed in the measuring channel, the display reads cuv.
When removing and inserting the cuvette, the display must show the
appropriate status.
The upper display shows lamp values. Lamp values inform
about the liquid turbidity. The information is for Dade Behring Service only.

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3 26 BFT* II Analyzer - Instruction Manual - Version 3.1
 4 Errors

4 Errors
Possible errors can be categorized in:

- Application errors: can be corrected with key functions

- non-fatal errors: can be corrected by the user
(see chapter 4.2 Non-fatal Errors)

- fatal errors: can only be corrected by Dade Behring Service

- analytical errors: refer to chapter 4.4 Troubleshooting

4.1 Application Errors 4

Cancel incubation
If the key Incub is pressed repeatedly, the current incubation will be
cancelled.

Cancel preparation to measure

• Press the Reset-key. The message "break" will appear for the respective
measuring channel.

Too many print-outs affected

The printer buffer is full. The print-out shows **PR-Buffer-Overflow**

4.2 Non-fatal Errors

Analyzer does not respond

• Verify that the BFT* II is connected to a power supply.
• Check fuses and proceed as described in chapter 4.5 Change Fuses.

Messages with respect to turbid-

ity in sample - too dark, bot lim,
top lim
Display:
break too dark: Sample preparation too turbid; plasma possibly
lipemic.
The sample cannot be measured!
Print-out: channel x break too dark

break bot lim: Sample preparation too turbid; the sample has been
adjusted but cannot be measured!
Print-out: channel x break bot lim

break top lim: Sample preparation very light; the sample has been
adjusted but cannot be measured!
Print-out: channel x break top lim

break drift: Fast drifting of measuring curve by particles in test

probe.
The sample cannot be measured!
(Air bubbles?)
Print out: channel x break drift

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 4 Errors

break
jump: When detecting a jump within a measuring signal the
measurement will be stopped and "break jump" will
be displayed. Air bubbles in the sample might cause
this.

Result: In all cases the measurement will be cancelled.

Display and print-out as described above.

False cuvette recognition

4 • Switch BFT* II OFF and ON (see chapter 2.1.1)

Measuring channel error

Monitoring of rpms:
Message:
break motor: Speed difference is >50 rpm from predetermined-
stirrer-speed
Print-out: t=8.0s, s/i=500/446rpm
channel x: break motor

t=meas. time;
s/i=predetermined- / real-stirrer-speed
x=measuring channel 1 or 2

Consequence: Message causes measurement to be cancelled.

Display and print-out as described above.

Important: Should this message appear frequently, please

contact Dade Behring Service.

Monitoring of the light path:

Message:
break range Turbidity is out of range.
Print-out: channel x: break range!

Consequence: Message causes measurement to be cancelled.

Display and print-out as described above.

break
readjust Message is displayed if the light value is too dark
during the adjustment phase.
Print-out: channel x: break readjust

Consequence: Message causes measurement to be cancelled.

Display and print-out as described above.

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4 2 BFT* II Analyzer - Instruction Manual - Version 3.1
 4 Errors

The following units will be monitored

during a measurement:
Measured
time: If 6000 s will be exceeded, an error message "time-
out" will be displayed.

Thresholds: If the thresholds of the optical control range exceed

a range of 1 - 700 digits, an error message "top lim"
/ "bot lim" will be displayed.

Measured
value: If liquid is too turbid the message "too dark" will be
displayed.
4
Consequence: Sample cannot be measured and may possibly be
too turbid.

Remedy: Should this message appear frequently, please

contact Dade Behring Service.

Temperature fluctuations
If temperature fluctuates during the measurement, the following information
will be included in the print-out: WARN: temp. unstable

Important: Avoid significant temperature fluctuations in your

working environment!

Remedy: Wait until the temperature fluctuations have been

corrected. Then switch to STANDBY mode to
monitor the temperature. Repeat previous measure-
ment.

4.3 Fatal Errors

Temperature error
Internal defects are continuously monitored. Hardware and software are
controlled.
If the temperature is too low, the information WARM UP will be displayed in
the STANDBY mode.

WARM UP 35.6 deg

< 1 PT >

Should the operating temperature of 37.4 °C not be achieved within

40 minutes even in a cool working environment, an error may have
occurred in the temperature control. Should the temperature exceed 37.4
°C the heat will be switched off.

Display: Cool down

Cool down 38.6 deg

< 1 PT >

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BFT* II Analyzer - Instruction Manual - Version 3.1 4 3

 4 Errors

In case the temperature is significantly higher, switch off the BFT* II.

CAUTION Fatal errors can only be corrected by Dade Behring Service.

Message:
Display: ERROR | xxx(xxx=error number)
4 Print-out: >>>ERROR<<< | xxx

The error message is sent via the serial interface. The beeper will send a
signal every second.

Result: The operation of the BFT* II is blocked!

Error in check sum

Message on
display only: parameter error! press any key

Read or write error occurred in EEPROM!

Result: The operation of the BFT* II is blocked!

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4 4 BFT* II Analyzer - Instruction Manual - Version 3.1
 4 Errors

4.4 Troubleshooting

Please check BFT* II, reagents, and accessories as described below prior
to contacting Dade Behring Service.

Difference of more than 1 second

between the two channels:
Verify that you are using the correct pipette and tips. Only use pipette tips
that have been approved for use on the BFT* II (see the current
BFT* II Reference Guide)

Was pipetting performed correctly? 4

Figure 10 BFT* II - Pipetting

When adding the reagent, make sure that

- the pipette is held vertically
- the reagent is pipetted quickly by pressing the plunger with a quick motion

Have the samples been carefully pipetted onto the bottom of the cuvette?

Has the reagent fully dissolved after resuspension?

Has the reagent been properly mixed prior to application? This is especially
important for reagents containing Kaolin.

Was the correct incubation time maintained for each measurement?

Was citrated plasma used (as required)?

Are the pipette guidance of the BFT* II or the red tongue of the light protec-
tion cap contaminated, possibly with Thrombin?
Clean with Dade Behring Washing Solution and a cotton tip.

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BFT* II Analyzer - Instruction Manual - Version 3.1 4 5

 4 Errors

Results deviate from expected

results:
Was the reagent dissolved correctly with distilled water of good quality?

Were reagents used before expiration?

Was the correct incubation time maintained?

Does the applied calcium chloride have the correct molar concentration for
the type of analysis?

Has the reagent been sitting for a longer time period at 37 °C without being
4 closed so that its concentration may have changed due to evaporation? See
package insert.

Was the correct reference curve applied for the reagent lot?

Was the reference curve entered correctly into the analyzer?

Has the patient plasma been tested within four hours after taking the blood
(as recommended in the package insert)?

Test timer stops sporadically

during analysis:
Is the surrounding temperature of the instrument extremely high? (>30°C)

Was citrate plasma used as required?

Are there any air bubbles in the cuvette?

Has the reagent dissolved properly?

Have possible interferences from other laboratory equipment, such as

centrifuges, been excluded?

Test timer stops at 5 to 8

seconds:
Was plasma pipetted without air bubbles?

Was the measurement carried out immediately after the display of xxx ul
GO?

Measuring timer does not start

after reagent has been added:
Was starting reagent pipetted correctly?

Is the plasma reagent mixture clear?

Measuring timer does not stop:

Is a stir bar located in the cuvette?

Was the pipetting procedure performed correctly?

Does the plasma contain additional anticoagulants, such as heparin?

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4 6 BFT* II Analyzer - Instruction Manual - Version 3.1
 4 Errors

Problems with Fibrinogen

analysis:
Has the correct reference curve been entered?

Have the reference curve points been correctly defined and entered?

If recommended, has Kaolin been added to the Thrombin reagent? By

adding Kaolin, the clot formation can be optically better presented and
hence optically read more easily.

4.5 Change Fuses

The main input filter on the rear of the instrument contains both the main
switch and the fuse holder. The instrument features a multi-use power pack
4
for main voltage between 90 and 264 V AC. There is no need to modify the
main voltage manually.

You may need to change the fuses if the BFT* II does not operate even
though it is properly connected.

NOTE

Use only Fuses 1.6 AT from Dade Behring.

• Switch off BFT* II.

• Disconnect BFT* II from power supply and remove cable.
• Carefully lift open the cover of the fuse holder. The use of a screwdriver
will be helpful. Refer to figure 11.

A red fuse holder becomes visible.

• Set the screwdriver in the upper slot of the fuse holder and drive the car-
rier out of the housing.

• To check for blown fuses remove the fuses from the fuse holder and see if
wires have melted. Replace fuses accordingly.

• Close the fuse holder cover.

• Reconnect BFT* II to power supply and check proper operation.

NOTE

Contact Dade Behring Service in case the exchange of fuses has been
unsuccessful.

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BFT* II Analyzer - Instruction Manual - Version 3.1 4 7

 4 Errors

pull
1 pull
2

a b
4
c

Figure 11 Change Fuses

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4 8 BFT* II Analyzer - Instruction Manual - Version 3.1
 5 Software

5 Software
The software for the BFT* II is stored in a flash memory and is activated as
soon as the analyzer is switched on.
It controls the analyzer via start functions for the analytic program.

Visual communication between the BFT* II and the user is accomplished via
a Liquid Crystal Display with two rows and 20 characters.

The display will lead you in a dialog through all measurement steps. The
user will confirm these steps either by key strokes or by pipetting start
reagent. Thus correct handling of the system will be guaranteed.

An overview of the BFT* II Software can be seen in Figure 12, chapter 5.1
Software Overview

A list of abbreviated terms and further explanations can be referred to in

chapter 6.11 Terminology & Abbreviations.
5
The menu UTILITIES has been integrated into the method menu so that
system settings can be performed.
Authorized personnel can access this group of menus by entering a secret
code number.

Without entering a secret code number, the user can

- perform tests
- change the test method
- change conversion parameter and reagent lot number

Once the secret code number has been entered, the user can
- change the method menu
- access all method parameters
- access all parameters in the menu UTILITIES

The preset methods in ROM memory cannot be changed by the user. They
are fixed together with the operating program.

The menu UTILITIES can only be exited by pressing Cal.

A submenu can be exited with Esc; a different submenu can be selected
next.

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BFT* II Analyzer - Instruction Manual - Version 3.1 5 1

 5 Software

5.1 Software Overview

BFT II
Power ON - Initialising
WARM UP
Software Version 2.01
remove all cuvettes
then press any key

auto blanking
keep channels clear

STANDBY 37.4 deg

<1 PT >

Cal
Enter >

5 Method parameter
secret no.:
Test run Method list

Cal
incubat incubat STANDBY 37.4 deg
..... cuv in cuv in <1 PT >
Direct access to special parameter

1) method parameter 42 s 54 s STANDBY 37.4 deg

< general > cuv in cuv in <2 aPTT >

1) method parameter incubat. incubat. STANDBY 37.4 deg

< 1st conversion > GO 100 ul GO 100 ul < 3 Thrombin Time > 1

1) method parameter incubat incubat STANDBY 37.4 deg

t= 6.2 s t= 7.4 s < 4 Batroxobin Time > 1
< 2nd conversion >

1) method parameter time time STANDBY 37.4 deg

< measurement > t= 12.5 s t= 12.7 s <5 Fib. g/l >

% % STANDBY 37.4 deg

93.0 90.4 <6 Fib. mg/dl >

INR INR STANDBY 37.4 deg

1.05 1.06 <7 Extr. Factor > 1

incubat incubat STANDBY 37.4 deg

cuv out cuv out <8 Intr. Factor > 1

STANDBY 37.4 deg

<9 PT-Innovin >
Cal
STANDBY 37.4 deg
General parameter < 10 ProC G PCAT > 1

secret no.:
STANDBY 37.4 deg
.....
< 11 ProC G PCAT/0 > 1

UTILITIES select:
STANDBY 37.4 deg
< printer >
< 12 ProC FV PCAT > 1

UTILITIES select: STANDBY 37.4 deg

< beeper > < 13 ProC FV PCAT/0 > 1

UTILITIES select: STANDBY 37.4 deg

< reagent-stirrer > 1 not available in the US. < 14 none >

UTILITIES select: STANDBY 37.4 deg

< secret number > < 15 none >

UTILITIES select: STANDBY 37.4 deg

< cuvette test > < UTILITIES >

Figure 12 Software Overview

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5 2 BFT* II Analyzer - Instruction Manual - Version 3.1
 5 Software

5.2 Connection to Host

The BFT* II has not been designed for connection to a host.

5.3 Method Parameters

The settings on the BFT* II are preset by the manufacturer.

Before routine tests can be performed, the user must change certain
reagent specific parameters such as lot number and reference curve
parameter.

The following parameters are preset:

Program version: 2.02
Method parameter: completely preset
Printer: ON/OFF question while power up
Beeper:
Reagent stirrer revolutions:
on/off/click
250 rpm
5
Security code: 11111
Cuvette recognition: ON
Preset: in ROM memory
Single determinations: only, for all methods

For a full list of available method parameters contact Dade Behring Service.

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BFT* II Analyzer - Instruction Manual - Version 3.1 5 3

 5 Software

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5 4 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

6 Appendix

6.1 Hazards and Precautions

The cautions and safety regulations in this instruction

manual meet international classifications.

DANGER Warns of a risk of injury or of a risk to life (for example, by electrical

shock).

Danger!

CAUTION Warns of a risk of injury or of the instrument being severely damaged.

The measuring result can be influenced.

6
NOTE
Introduces rules to be observed.

The following caution and safety regulations must be observed at all

times:

A Electrical Safety

DANGER Check the operating voltage before you connect the device to the main
power supply.

To connect the device to the power supply, use only sockets which are
Danger! grounded in order to keep the risk of an electrical shock as low as
possible. Use only grounded extension cables.

Never intentionally disconnect the grounding contacts.

There is the risk of electrical shock if:
- the protective conductor is interrupted within or outside the device,
and/or
- the grounded contact has been disconnected from the line.

Other than the light protection cap, never remove screwed-in casing
parts, protective guards or secured components since this could
expose electrically live parts.

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BFT* II Analyzer - Instruction Manual - Version 3.1 6 1

 6 Appendix

Electrical connection contacts (plugs, sockets etc.) can be electrically

live.
Even after the device has been switched off, components (e.g.
capacitors) can be under voltage as the result of an electrical charge.
All current carrying parts are sources of danger for an electrical shock.

Surfaces (floors, work table) must not be moist when you are working
with any electrical device.

Do not use the device on a moist surface.

Carry out only the maintenance work and/or the replacement of

parts described in these operating instructions.
Unauthorized work on the device can lead to the guarantee obligation
becoming null and void with necessary expensive service work to
correct it.

6 All work which requires the instrument to be opened may only be

carried out by a technician who is familiar with the risks related
thereto.

Use only replacement fuses of the stated type and with the stated
nominal current.
Never use fuses which have been "repaired".
Never short-circuit the fuse holder.

B Fire and Explosion Hazards

CAUTION Do not place any flammable or hazardous explosive material in the
proximity of the BFT* II.
Electrical sparks could cause fire or explosions.

C Mechanical Safety
(BFT* II in operation)

CAUTION Never open screw-attached housing parts while the instrument is ON.
There is a risk of injury due to moving parts (fan, motor drives).

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6 2 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

D Samples

DANGER Risk of infection

Avoid any direct contact with samples which are potentially infectious or
which may generate other risks to the human body.
If sample material is spilled onto the BFT* II, wipe it off immediately and
decontaminate the analyzer (refer to chapter 6.2 Maintenance and
Hygiene).

E Reagents

CAUTION Observe the suggestions in the package inserts for a correct use of the
reagents. Wear gloves.

6
F Waste Solution

CAUTION Dispose of used plasmas and reagents in compliance with biohazard

and legal provisions. Wear gloves. Risk of infection!

G Accuracy and Precision of the

Results

CAUTION In order to ensure flawless operation of the BFT* II measure control

samples and watch the function of the instrument closely.
Faulty measurement results may result in an incorrect diagnosis or
therapy.

H Operator Qualification

CAUTION The BFT* II should be operated only by trained personnel.

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BFT* II Analyzer - Instruction Manual - Version 3.1 6 3

 6 Appendix

I Room Temperature

CAUTION Avoid significant temperature changes in your working environment so

the temperature in the incubation block remains constant. If the
incubation block does not have the correct temperature, measured
results can be faulty.

6.2 Maintenance and Hygiene

CAUTION No alcohol or organic acid based cleaning substances should be

applied. Instead use cleaners designed for cleaning and disinfecting
laboratory instruments. Only use a dampened cloth to clean the instru-
ment. Never spray or pour cleaning solution directly onto the instrument.

6
Keep the instrument clean and do not spill liquids onto the analyzer.
To protect the instrument from dust, cover it with the supplied dust cover or
store instrument in a cabinet when not in use.

In case liquids were spilled onto the instrument, immediately absorb liquid
with an appropriate cloth.

If liquid has accidentally run or was pipetted onto the red tongue of the light
protection cap or into the measuring channel, remove the liquid with a
pipette and clean the light protection cap and/or the measuring channel with
a lint-free cloth (refer to chapter 2.1.3 Measuring).

NOTE

Contact Dade Behring Service if your measurement does not produce

the expected results.

6.3 Disposables
NOTE

To order disposables, please contact your Dade Behring Service.

Cuvettes
5 x 500 cuvettes and 500 x mixers
or
500 cuvettes with mixers („Dispo System“)

Thermo paper
Printer paper for BFT* II

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6 4 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

Eppendorf pipette tips

Ordering information for pipette tips that have been approved for use on the
BFT* II can be found in the current BFT* II Reference Guide.

6.4 Materials provided

1x BFT* II
1x 100 cuvettes (Dispo-System)
3x Reagent bottle adapter GW 5 for 5 ml reagent bottles
1x Teflon reagent stir bar
1x Dust cover
2x Replacement fuses 1.6 A
1x BFT* II Analyzer Instruction Manual
1x Printer paper
1x Paper rail (one set)

6.5 General Specifications

Instrument type Analyzer for determination of plasmic clotting.
6
Application coagulometric tests such as PT, APTT, TT1,
Fibrinogen, Batroxobin time1, single factors FII -
FXII1. Contact Dade Behring for all applicable
methods and reagents

Restrictions Only for traditional, coagulometric clotting tests

(no chromogenic substrates)

Operation manual

Measuring channels 2 measuring channels with light protection cap

Light protection cap for protection against foreign light plus guide for
Eppendorf pipette tips.

Measuring principle turbodensitometric, opto-mechanical with auto-

matic zero adjustment and magnetic stir bar for
homogenizing of the test suspension and
increased sensitivity.

Measuring timer max. 6000 s, error < 0.1 s

Lag phase 2 - 15 s depending on method

Sensitivity PT> 5 % of norm

Test throughput / hour PT 60, APTT 30, +/- 20

Cuvette volume 150 µl - 225 µl (test suspension)

Calibration manual input of reference curve points, method

dependent

Reagent vials 4 positions GW 15 - bottles or GW5 bottles using

reducer rings

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BFT* II Analyzer - Instruction Manual - Version 3.1 6 5

 6 Appendix

Software loaded in memory

Programmed methods can be reloaded from Preset (ROM)

Reference curve Reference curves programmable with 9 reference

curve points each

Light source light emitting diode, light intensity according to

turbidity of sample

Display 2 lines with 20 characters each liquid crystal dis-

play

Processor MC68331 (micro controller)

Incubation block controlled at 37.4 °C +/- 1.0 °C

1 reagent mixer function with a preset speed of
250 rpm
6 Cuvette positions 30 - 2 x 3 rows with 5 positions each

Disposables Cuvettes/stir bars, printer paper

Interface RS 232 C, Mini-DIN

Power requirements average power consumption of 63 VA

Voltage 90 - 264 VAC

Fuses Fuse 1.6 AT

Type 5 x 20 mm glass tube fine-wire fuse according to

DIN 41571
0.197" x 0.787" UL listed 314F CSA
Replacement US-norm 6.3 x 32 mm fine-wire fuse

Environmental Temperature: +10 - 30 °C

conditions Relative humidity: less than 85%,
no condensation

Printer 58 mm thermo-printer with external paper roll

(50 m)
Dimensions 20 cm x 30 cm x 10 cm (WxDxH)
Weight 3.8 kg

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6 6 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

6.5.1 Disposal of BFT* II

NOTE

Please contact Dade Behring Service regarding disposal of the instru-

ment or instrument components.

The following features should be observed when disposing of the BFT* II:

- the top and bottom housing are made of polyurethane foam.

- mechanical parts are mostly made of aluminum and precious metals.
- electronic parts must be disposed of in accordance with the guidelines for
the disposal of electronic parts

• Make sure that the BFT* II has been decontaminated before disposal.

6.6 Specifications for Safety

The instrument conforms to the relevant European regulations.

The instrument described in this manual bears a CE mark which confirms

6
the compliance with the essential requirements of the following European
directives:

If the instrument's typeplate bears an IVD symbol it complies with the

following directive:
- 98/79/EC In-Vitro Diagnostics directive

If the instrument bears no IVD symbol on the typeplate it complies with the
following directives:
- 73/23/EEC Low-voltage directive
- 89/336/EEC-EMC directive

Interference suppression
The instrument was checked according to EN 50081-1, EN 50082-1 and EN
61000-4-2 to EN 61000-4-5 and meets the requirements of limit value class
B. The use of screened data cables is a precondition for compliance with
the relevant regulations. The user is responsible for ensuring that screened
data cables are used.

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BFT* II Analyzer - Instruction Manual - Version 3.1 6 7

 6 Appendix

6.7 Meanings of the symbols on the adhesive labels of the accessories

Several symbols are printed on the adhesive labels of the accessories
which have the following meanings:

Manufacturer

In vitro diagnostic device

Batch code

6
CE mark

Catalogue number

Consult instructions for use

Do not reuse

Best before

Temperature limitation

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6 8 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

6.8 Mathematics
Computations for coagulation methods:

Computation of Factor for PT

refer. curve:
Determine the 100 % value in seconds (e.g. 12.2 s) and the 25 % value in
seconds (e.g. 29.3 s) from regular plasma in double determination and
proceed as follows.

Computation of Factor:
( 25 % Value in sec ) - ( 100 % Value in sec )
———————————————————— = Factor
(1/25) - (1/100 %)

or

29.3 - 12.2 17.1

——————— = ————— = Factor = 570
1/25 - 1/100 0.04 - 0.01 6
Computation of PT %
1
---------------------------------------------------------- = PT %
(( meas. time - 100% time) / factor) + 0.01)

Conversion limits:
In general the tolerances for the conversion can be programmed. See chap-
ter 3.1.5.1 PT Parameter conversion limits min/max values.

Interpolation
Linear from reference point to reference point.

Extrapolation
PT: >100 % extrapolation over the last two higher points.
Extrapolation factor: 1.5
PT: < 10 % extrapolation over the last two lower points.
Extrapolation factor: 0.5

Fibrinogen: Extrapolation respectively over the last two points.

Conversion to INR:
INR = RATIO ISI
(International Normalized Ratio)

ISI = International Sensitivity Index according to the table of assigned

values

1 not available in the US

BFT* II Analyzer - Instruction Manual - Version 3.1 6 9

 6 Appendix

6.9 Print-outs

General print-outs
After a method has been selected the programmed reference curve param-
eters are printed prior to printing the results.

The print-out is performed automatically as soon as the measuring channels

have produced a result.

NOTE

Sequential numbers will be assigned in the order of print-outs and not in

the order of measurements started.

Each method has its own counter. As soon as the BFT* II has been
switched on, the counter starts with "1". This feature can be set in menu
method parameter / measurement - printout number.

Print-out of all parameters

6 As described in chapter 3.2 Utilities, a print-out of all programmed test
parameters can be initiated.

Print-out of method parameters

By pressing the 0-key in the measuring mode, a method specific parameter
print-out can be generated for the selected method. The printer must be set
to ON in UTILITIES <printer>.

Print-out for PT
PT documentation
Example: conversions via a 4 point reference curve
(max 9 point) in %, INR as an example

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6 10 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

-- method store 1 ----

´PT´
cuvette ON

start-reagent:
Lot 505400
reagent = 100 ul
(0=off)

incub.1= 0s
(0=off)
incub.2= 60 s
(0=off)

1st convers INTERPOLAT.

2nd convers INR
ISI = 1.14
(-> 100% = 11.5 s) the 100% value will only be cal-
culated and printed if it is not 6
97.0% 11.5 s typed in.
43.0% 20.1 s
23.0% 31.9 s
12.0% 57.0 s

------------------------------
results
left channel

results
right channel
PT . Point = diff. to preset method
patient _____________ patient name entry
No. = 1 print-out number 1 .....
time = 24.5 s measured time in seconds
INR = 2.20 conversion in INR
% = 36.4% conversion in PT %

Additional:

% > 150 upper conversion limit

% <5 lower conversion limit

ERR div0 calculation error -

Division through 0

1 not available in the US

BFT* II Analyzer - Instruction Manual - Version 3.1 6 11

 6 Appendix

6.10 Description of Interfaces

The following section will describe how measured results can be received
by the BFT* II via an asynchronous serial interface. Other data types of the
BFT* II will not be described.

Hardware
Mini-DIN round connector on the back of the BFT* II.
Assignment:
-Pin 1= do not use, for manufacturer only !
-Pin 2= GND
-Pin 3= CTS
-Pin 4= TXD
-Pin 5= do not use, for manufacturer only !
-Pin 6= RXD

Send and receive with 9600 Baud, 8 data bits, 1 stop bit, without parity bit.
Handshake possible with CTS-input, but the connected instrument should
be able to receive without handshake with 9600 Baud.

6 6 5

4 3

2 1

Figure 13 Mini-DIN round connector on the back of the BFT* II

Software
Transmission format:
The BFT* II transmits each message in the following format:
STX <code><data> ETX <BCC><CR><LF>

whereby:
- STX byte $02
- <code> byte to label the type of message
- <data> a sequence from 1 - 256 bytes
- ETX byte $03
- <BCC> 2 bytes from the character set ‘0’..’9’, ‘A’..’F’.

These bytes compose a hexadecimal representation of a number in the

range 0...255. This number constitutes the checksum of the message and is
computed as follows: Modulo-256-sum over all bytes of the message,
except for STX, CR, LF and <BCC> itself.

The receiving unit (e.g. a PC) must confirm each message:

- with ACK (byte $06), if a message has been received correctly, or
- with NAK (byte $21), if a message has been received incorrectly.

If a message has been confirmed with NAK or the BFT* II did not receive a
confirmation within approximately 300 ms, the BFT* II will send the
message again. The same message can be sent up to three times.
Depending on the number and priority of other messages to be sent, fewer
repeats or even no repeats may be possible.

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6 12 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

Message for measured result

The code for the message "measured result" is ‘E’ and consists only of
visible ASCII-characters.
The code is followed by a channel number with ‘1’ for the left channel and ‘2’
for the right channel.

All other data is separated from the channel number by a space. The data
consists of:
-measured time in seconds with one decimal
-first conversion
-second conversion
-alarm code

Example (without transmission format):

E1 12.5 98.0 1.17 0

The message for a measured result means:

-measured result from channel 1
-measured time 12.5 seconds
-first conversion 98.0
-second conversion 1.17
6
-alarm code 0

If conversions are set to off, '0' will be shown in the respective places.

The following alarm codes can occur at this time:

- 0: no alarm, everything O.K.
- 21: result from first or second conversion not within normal range
- 22: temperature error during incubation or measurement

Procedure
A program that wants to receive measured results from the BFT* II can
ignore all messages whose code is not ‘E’ but must confirm them
immediately with ACK.

1 not available in the US

BFT* II Analyzer - Instruction Manual - Version 3.1 6 13

 6 Appendix

6.11 Terminology & Abbreviations

Term Meaning

A
auto blanking automatic adjustment
activation activation period

B
beeper acoustic signal
break too dark refer to chapter 4.2
break bot lim refer to chapter 4.2
break top lim refer to chapter 4.2
break jump refer to chapter 4.2
break motor refer to chapter 4.2
break readjust refer to chapter 4.2
break range refer to chapter 4.2
break drift refer to chapter 4.2

C
6 Cal
cuv in
calibration
insert cuvette into measuring channel
cuv out remove cuvette from measuring channel
calibrate temp temperature adjustment
cool down Temperature is > 37°C, refer to 4.3

D
deg degree, °C

E
Esc escape
extr. extrinsic system (Factor II, V, VII, X)1
ERROR I xxx Technical error, see chapter 4.3

F
factor factor for PT reference curve

G
Go continue, next step
g/l grams / liter

I
incub incubating
incubat. incubation time
INR (inr) International Normalized Ratio
ISI International Sensitivity Index
intr. Intrinsic System (Factor VIII, IX, XI,XII)1

K
Keep channels-
clear keep channels empty

L
lot no. Lot number

1 not available in the US

6 14 BFT* II Analyzer - Instruction Manual - Version 3.1
 6 Appendix

M
more param. more parameters
mixer stir bar speed

O
on active
off not active

P
point point on the reference curve
parameter error write/read error, refer to chapter 4.2

R
ROM read-only-memory
RAM random access memory

S
secret no. secret number, secret code
s (60 s in display) seconds
StartReag starting reagent
6
T
t time
timeout refer to chapter 4.2
top lim / bot lim refer to chapter 4.2
too dark refer to chapter 4.2

U
ul µl = Microliter

W
writing para-
meters to internal saving parameters
work measuring mode

WARN:
temp. unstable warning, temperature unstable
refer to chapter 4.2

other:
% activity in percent

1 not available in the US

BFT* II Analyzer - Instruction Manual - Version 3.1 6 15

 6 Appendix

1 not available in the US

6 16 BFT* II Analyzer - Instruction Manual - Version 3.1
 Index

Index curve axes 6-9

cuvette recognition 3-24

Cuvettes 6-4

activity 3-10 D
Additional requirements and recommendations 1-7 decimal place 3-14

arrow - keys 1-1 Declaration of conformity 6-9

Delete character 3-5

B Direct parameter access 3-1

blank character 3-5 Disposal of BFT II 6-7

Bullets 2-1

C Electrical Safety 6-1

Calibration curve Eppendorf pipette tips 6-5

axes 6-9 Extrapolation 6-9

points 3-15

Cancel incubation 4-1

F
Cancel preparation to measure 4-1
Factor 6-9
Change paper 2-2
factor 3-17
Change to Operation Mode 2-4
falling curve 3-13
Change to STANDBY Mode 2-3

character generator 3-4

H
cleaning substances 6-4

colored samples 1-6 Host connection 5-3

concentration 3-10

Contamination 1-7 I
conversion example 6-10
INR 6-9
conversion limits 3-14, 3-16
Installation 1-5

BFT* II Analyzer - Instruction Manual - Version 3.1 IX 1

 Index

interpolation 3-15 Q
ISI-value 3-18
quality control 1-7

quick with factor 3-10, 3-16

L

Light protection flap 6-5 R

lipemic 1-6
RAM/ROM memory 2-1

ranges 3-10
M
ready for operation 2-2

Measuring 2-4 Reagent volume 3-18

Measuring Principle 1-6 Reagents 1-7

Mechanical Safety 6-2 reference curve 3-10

Menu 3-10 reference value 3-10, 3-17

Method rising curve 3-13

Parameter 3-1
Room Temperature 6-4
parameter groups 3-2
Parameters 5-3 RS 232 1-1

min value 3-20

mixer function 3-19 S

Sample incubation 2-4

P Save parameters 3-4

photodetector 1-6 Security code 5-3

power jack 1-1 Selftest 2-1

power supply 1-5 Single determination 2-4

Printer 2-3 STANDBY Mode 2-3

Print-out stir function 3-19

of all parameters 6-10 end speed 3-19

of method parameters 6-10 starting speed 3-19

stir bars 1-6, 2-2
Program version 5-3
stiring 1-6
PT 3-12

IX 2 BFT* II Analyzer - Instruction Manual - Version 3.1

 Index

Switch ON/OFF 1-5

Temperature
error 4-3
fluctuations 4-3

Thermo paper 6-4

turbidity 1-6

turbodensitometric measuring principle 1-6

unit 3-14

User qualification 2-1, 3-1

UTILITIES 2-8

WARM UP 2-2

Waste Solution 6-3

BFT* II Analyzer - Instruction Manual - Version 3.1 IX 3

Index

IX 4 BFT* II Analyzer - Instruction Manual - Version 3.1