Biosen C Line. Operator's Manual

BIOSEN C_line
GP
Operator’s Manual
The copyright of this document is protected! Copying and distribution to
third parties only by written permission of EKF-diagnostic GmbH.
Subject to modifications. Errors excepted.
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Phon.: +49 (0) 39203 / 785 - 0

Fax.: +49 (0) 39203 / 785 - 16
Stand: 11/2005
Revision: 1.1
Software-Version: HMIC-1.01.00 / PIC-1.01.00

CONTENTS
1. INTENDED USE ..............................................................4
2. IMPORTANT INFORMATION .........................................4
2.1. EXPLANATION OF THE SYMBOLS USED .............................4
2.2. SAFETY NOTES ..............................................................5
2.2.1. General notes .....................................................5
2.2.2. Moving parts........................................................6
3. DESCRIPTION OF COMPONENTS................................7
4. SETTING UP....................................................................8
4.1. UNPACKING THE DEVICE .................................................8
4.2. INSTALLING THE DEVICE..................................................8
4.3. ELECTRIC POWER SUPPLY AND INTERFACE ......................9
4.4. CONSUMABLES REQUIRED ..............................................9
4.5. PUMP TUBE..................................................................10
4.6. SWITCHING THE DEVICE ON AND OFF .............................10
5. DESCRIPTION OF TOUCHPANEL ..............................11
5.1. BUTTON SYMBOLS USED ...............................................11
5.2. NAVIGATION AND OPERATION ........................................13
5.3. DEVICE MESSAGES.......................................................13
6. PREPARATION FOR MEASUREMENT OPERATION 14
6.1. CHIP SENSORS.............................................................14
6.1.1. Fitting sensors...................................................14
6.1.2. Changing sensors .............................................15
6.2. PREPARATION OF SAMPLES ..........................................18
6.3. CALIBRATION SOLUTIONS..............................................19
6.4. CONTROL SOLUTIONS ...................................................20
6.5. FITTING OF SAMPLES ....................................................20
6.6. BARCODE (OPTIONAL) ..................................................20
6.6.1. Barcode format .................................................20
6.6.2. Specification of the barcode label .....................21
6.6.3. Positioning of the barcode label........................21
7. MEASUREMENT OPERATION ....................................22
7.1. “READY TO MEASURE” DISPLAY WINDOW .......................22
7.2. SAMPLE MEASUREMENT ...............................................23
7.3. CONTROLS ..................................................................24
7.4. STAT..........................................................................25
BIOSEN C_line Clinic - operator`s manual -1-

8. MEMORY ...................................................................... 25
9. INFO MENU .................................................................. 26
10. MENU........................................................................ 26
10.1. STAND-BY ................................................................... 26
10.2. NUMBERING ................................................................ 26
10.2.1. Sample positions .............................................. 26
10.2.2. Special positions .............................................. 26
10.3. DEVICE SETTINGS........................................................ 27
10.3.1. Calibration mode .............................................. 27
10.3.2. Sensor selection............................................... 27
10.3.3. Units ................................................................. 28
10.3.4. Test type........................................................... 28
10.4. W ARNING LIMITS ......................................................... 28
10.4.1. Samples ........................................................... 28
10.4.2. Control 1........................................................... 28
10.4.3. Control 2........................................................... 28
10.4.4. Breach of limits................................................. 29
10.5. DATE / TIME ................................................................ 29
10.6. SELECTING PRINTER TYPE ........................................... 29
10.7. EDP........................................................................... 29
10.7.1. Transfer protocol .............................................. 29
10.7.2. Transmission parameters................................. 29
10.7.3. Preamble / Postamble...................................... 30
10.7.4. Device identifier................................................ 30
10.7.5. Method number ................................................ 30
10.7.6. Request operation ............................................ 30
10.7.7. Sending a test telegram ................................... 30
10.8. REGION ...................................................................... 31
10.9. BARCODE ................................................................... 31
10.10. SERVICING THE DEVICE ........................................... 31
10.10.1. Cleaning/ disinfection................................... 31
10.10.2. Empty system .............................................. 31
10.11. MENU TYPES .......................................................... 32
10.12. EXTRAS .................................................................. 32
10.12.1. Contrast / Tone ............................................ 32
10.12.2. Histories ....................................................... 32
10.12.3. Device control .............................................. 33
10.13. CONTACT ............................................................... 33
11. CONNECTION TO OTHER DEVICES ..................... 33
11.1. PROTOCOL PRINTER .................................................... 33
11.1.1. Serial printer ..................................................... 33
-2- BIOSEN C_line-Clinic operator`s manual

11.1.2. Parallel printer ...................................................34
11.2. EDP CONNECTION .......................................................34
11.2.1. Connector pin assignment ................................34
11.2.2. Structure of data protocol..................................35
12. PUTTING OUT OF SERVICE ...................................36
12.1. EXPLANATION ..............................................................36
12.2. BRIEF SEPARATION FROM POWER SUPPLY (< 72 H)........36
12.3. LONGER SEPARATION FROM POWER SUPPLY (>72 H) .....37
13. SERVICING THE DEVICE ........................................37
13.1. CLEANING AND DISINFECTION .......................................37
13.2. MAINTENANCE PARTS ...................................................39
13.2.1. Pump tube.........................................................39
13.2.2. Exchanger and sample cannula .......................40
14. TROUBLESHOOTING ..............................................41
15. TECHNICAL DATA ...................................................43
16. LIST OF CONSUMABLES AND MAINTENANCE PARTS 45
17. THEORETICAL PRINCIPLES ..................................48
18. STATEMENT OF CONFORMITY .............................49

1. Intended Use
The BIOSEN C_line system is designed for quantitative determination of
glucose and lactate concentration in human blood, plasma and serum.
The test sample is collected via an end-to-end capillary, transferred to a
pre-filled micro test tube and then measured by the device.
As potentially infectious waste material, the consumable products must be
disposed of according to the regulations in force in your establishment.
The BIOSEN C_line is designed for professional use in doctors‘ practices,
in clinics, in clinical laboratories, as a support for doctors‘ diagnoses and for
use in sports medicine.
The taking of blood and operating of BIOSEN C_line must be carried out
exclusively by medically trained personnel with a sound knowledge of in-
vitro diagnostic procedures and this device.
2. Important information
2.1. Explanation of the symbols used

The following symbols are used in this operator’s manual:
The DANGER symbol

This symbol warns of situations or actions which could
DANGER! lead to serious damage to the health of the user or a patient.
The WARNING symbol

This symbol warns about false handling which could cause
WARNING! Measuring errors or damage to the instrument or any
accessories used
The TIP symbol

Alongside this symbol we provide useful additional information
about the current matter.
TIP

2.2. Safety notes
2.2.1. General notes

It is essential that you read the following instructions in order to avoid the
possibility of danger to persons and damage to the device and other
objects. EKF-diagnostic GmbH is not liable for damages arising from non-
observance of the following instructions.
Follow the operator`s manual!

Every operation of the device requires exact knowledge of
WARNING! and adherence to this operator`s manual. Use the device only
for the purpose described in pt. 1, p.4.
Danger of fatal electric shock!

• Do not open the device under any circumstances.
DANGER! • Never use a mechanically damaged device.
• The device is not splash-proof. Avoid major contact
with fluids. Instructions for cleaning and disinfection
are under pt. 13.1, p.37.
• When a fluid spillage is suspected you should pull the
plug immediately.
• The device should only be operated at a power
connection with a correctly installed ground
Check whether the connection values given on the label

agree with that on the power connection.
WARNING!
Do not operate the device in areas where there is a risk

of explosion!
DANGER! It is not permitted to operate the device in areas where there
is a risk of explosion.
Allow the device to reach room temperature!

Particularly on changing from a cold into a warm
WARNING! environment (e.g. after storage or transport) condensation
can form inside and on the outside of the instrument. Hence
wait an approprate time (approx. 1h), before you connect to
the mains or switch on the device.

Use only original accessories!
Use only accessories and consumables which are expressly
WARNING! approved for use with the BIOSEN C_line.
Danger of infection
The device processes blood samples. This involves potential
WARNING! danger of infection. Particularly the sample cannula, the
exchanger, the chip sensors, the tray and the waste container
can be contaminated. Gloves should always be worn when
operating the device.
Maintenance
The device should be subjected to yearly inspections and
WARNING! servicing. It is recommended that you make a service
contract. Maintenance and repairs to the device can only be
carried out by EKF-diagnostic GmbH or other services
authorised by EKF. Further instructions on servicing can be
found in pt. 13, p.37.
2.2.2. Moving parts

The device contains parts which can move unexpectedly during normal
operation. The forces applied are structured in such a manner that any
danger of injury is out of the question. The device also has a mechanism
which immediately stops the appropriate components in case of blockage.
It is nonetheless recommended that you do not touch these parts during
operation, since the device may then immediately abort a measurement
operation in progress.

3. Description of components
Front view:
Figure1
1 Display with Touchpanel

2 Position for sample
3,4 Positions for Control 2 and 1 (C2, C1)
5,6 Positions for Standard 2 and 1 (STD2, STD1)
7 Exchanger (maintenance part)
8 Sample cannula (maintenance part)
9,10 Lifter, pivot arm
11 Tube (maintenance part)
12 Pump with pump flap
13 Sensor lid - measuring channel 1
14 Sensor lid - measuring channel 2
15 Opening for bottle containing system solution
16 Opening for waste bottle
17 Waste bottle with lid, colour code black
18 Bottle for system solution with lid, colour code red

Rear view:
1 Parallel interface
for printer - general
2 Serial interface
for printer - DPU 414
3 Serial interface
for EDP connection
4 Power connection with
2 fuses
Figure 2
4. Setting up
4.1. Unpacking the device

The delivery scope includes the following components:
• BIOSEN C_line device

• Bottles for system solution and waste
• Power cable
• Operator`s manual
• Optional printer DPU414 with printer cable and mains adapter
• Optional EDP cable
4.2. Installing the device

Allow the device to adjust to the surrounding temperature for
approx. 1 hr without the power connection.
WARNING!
Conditions at location of installation:

• Ambient temperature 15°C – 35°C
• Relative humidity 20% - 85%
• No direct exposure to damp
• No direct exposure to sunlight
• No strong electromagnetic fields
• No ionising radiation

• No rapid temperature changes caused by windows, doors, air
conditioning systems or similar
• A flat, water-proof base
• Free space on the ground required across the whole of the
installation area for ventilation.
4.3. Electric power supply and interface

The device has the following electrical connection specifications:
• 100V AC – 230V AC
• 50Hz – 60Hz
• approx. 20VA
• Socket with ground wire connection essential
Do not connect the device yet – first further preparations must

be made.
TIP
The following accessory parts can optionally be connected to the device:
• Protocol printer, currently only DPU414 (serial connection) with

printer cable. The printer is connected to serial outlet 2
(see Figure 2 – p. 8).
• EDP connection. The laboratory computer is connected to serial
outlet 3 (see Figure 2 – p. 8).
Further important instructions regarding the connection of the

printer and the computer can be found under pt. 11 – p.33.
TIP
4.4. Consumables required

The following consumables are required (see pt. 16 – p. 45):
• System solution – pour into the system solution bottle

(see Figure1 (19) – p. 7) and place in the appropriate opening
(see Figure1 (16) – p. 7).
• Place the empty waste bottle (see Figure1 (18) – p. 7) in the
appropriate opening (see Figure1 (17) – p. 7).
• Insert chip sensors for glucose or lactate measurement.
• Keep pre-filled micro test tubes ready to receive the sample.

• Place the micro test tubes with the calibration solution in position
STD1 and / or STD2 (see Figure1 – p. 7 - no. 3,4).
• If required place the micro test tubes with control solution in C1 and
/ or C2 (see Figure1 – p. 7 - no. 5,6).
4.5. Pump tube

The device is delivered from the factory with a pump tube which is
connected but hung externally, in order to avoid the tube becoming stuck
when at rest. When setting the device up for the first time the tube must be
hung on again. Figure 3 shows the pump with pump flap open (turn up from
right to left) and Figure 4 shows the tube being hung on.
State on delivery
Figure 3
The tube must be hung on again. A

rounded pair of tweezers is useful for
this. The tube must lie in the middle
over the pump rollers. Do not use
sharp objects for this. Next turn the
pump flap down from left to right.
Figure 4
4.6. Switching the device on and off

The device is designed for continuous operation. The chip sensor and the
flow system need to carry out internal device functions which can only be
realised with a power supply. For this reason the device has no separate
- 10 - BIOSEN C_line-Clinic operator`s manual

power switch, but is separated from the power supply or connected to it
(cold start) via the socket.
It is possible to place the device in Stand-by mode. This reduces the
consumption of system solution and energy to a minimum.
Separating the device from the power supply is only

recommended if the device will not be needed for a long period
TIP of time (over 4 weeks). However, the device cannot be simply
separated from the power supply, but must be put out of service
properly. Important notes on this subject can be found under pt.
12 – p. 36.
5. Description of Touchpanel
The Touchpanel (see Figure1 (1) – p. 7) replaces a traditional keyboard
and allows the device to be operated intuitively.
• Only apply light pressure when pressing

• Do not use sharp objects
WARNING! • Do not use solvents for cleaning
In order to avoid undesired operation of the device when

cleaning the Touchpanel, the system solution bottle should be
TIP removed.
5.1. Button symbols used
In the Menu:
Moves the menu bar up and down.
In the Settings Menu:
Changes figures or settings.
In the Memory:
Scrolls to the previous or next measurement stored including
calibrations and controls.
In the Memory:
Scrolls to the previous or next measurement stored without
displaying calibrations or controls.
BIOSEN C_line Clinic - operator`s manual - 11 -

When ready to measure:
Calls up the Menu.
In the Menu, in sub-menus:

Calls up the next, deeper menu level.
Quits the Settings Menu having applied changes.
In the Menu, in sub-menus:

Moves back to the next highest menu level.
Quits the Settings Menu without applying changes.
When ready to measure, during measurement operation:

Provides information on device settings.
When ready to measure, during measurement operation:

Calls up the readings memory.
During measurement operation:

Interrupts a measurement or calibration in progress. The tick
confirms the button press. The device nonetheless first finishes
the current measurement or calibration.
When ready to measure, during measurement

operation:
A STAT can be set. The STAT is automatically recognised and
confirmed by the tick. By pressing the
button the quick test can be deregistered again (the tick
disappears).
During measurement operation:

Measurement is started.

In Stand-by:
The device is in Stand-by mode and can be started by pressing a
button (warm start).
During the warm start:

The device is in the warm start phase (switched on).
If the button is pressed once more, the device reverts to Stand-
by.
The tick denotes acceptance of the button press.
5.2. Navigation and operation
• A position bar shows the currently selected menu option. If an

arrow is shown to the right of this menu option, this menu option
contains further sub-options.
• In the Settings Menu values or settings can be changed using the
arrow keys.
• If there are several changeable values or settings within one option
in the menu (including the Settings Menu), the value to be changed
must first be activated by touching the key area. The frame
surrounding becomes darker when it is activated and indicates the
activation in this way. Now this value can be changed using the
arrow buttons. Other values to be changed within the menu option
can be treated in the same way.
• If figures in the menu (date, limits etc.) need to be changed by a
large amount, it is advisable to keep the arrow buttons pressed
down continuously.
5.3. Device messages

Device messages are always shown in a separate window. There are
basically the following windows:
Advice window – with corresponding instruction text

• Advice windows cannot be confirmed. The instruction
displayed must be followed, and then the window
disappears automatically.

• Example:
"Please insert sensor"
Question window – with corresponding question text

• Set device to Stand-by? "Yes" or "No".
• Example:
"Switch device to Stand-by?"
Error window – with corresponding error text

• There are error texts which have to be confirmed.
• Example:
"Lifter error, lifter is blocked"
After confirmation the device attempts to remove the fault.
• There are error texts which cannot be confirmed.
• Example:
"No system solution"
To remove this fault the bottle with system solution has to
be refilled.
• There are system errors which cannot be confirmed and
which prevent measurement operation. When such errors
occur, you must consult service personnel.
• Example:
"System error"
6. Preparation for measurement operation
6.1. Chip sensors

EKF chip sensors are the core of the measuring system. They transform
the sample concentration (glucose, lactate) into an evaluable electrical
signal. Further information on this subject can be found under pt. 17 p.48.
6.1.1. Fitting sensors

EKF-diagnostic GmbH offers chip sensors for glucose and lactate
measurement for the device.
Only chip sensors of type II (glucose or lactate) from EKF-

diagnostic GmbH may be used (see pt. 16 – p. 45).
TIP
Automatic recognition: The device recognises the chip sensor (glucose

or lactate) automatically. It is not possible to make manual settings.

Measuring channels: The device has at least 1 measuring channel,
optionally 2 measuring channels. In the latter case glucose and lactate can
be measured simultaneously from one sample.
Equipping measurement channels: it is immaterial which sensor

(glucose, lactate) is placed in which measuring channel. In theory it is also
possible to use the same parameter on both measuring channels. It is
recommended to always equip measuring channel 1 with glucose and
measuring channel 2 with lactate.
Blind sensor: If a device with two measuring channels is operated with

only one sensor, there needs to be a blind sensor (accessory) in measuring
channel 2. In this case fitting the active sensor in measuring channel 1 is
recommended (higher measuring speed).
If there is no blind sensor at hand, an old measurement sensor can be
used. In this case, however, the device cannot recognise that
measurement channel 2 is meant to be inactive. It is necessary to
additionally deactivate this sensor in the “Sensors“ menu option.
6.1.2. Changing sensors

Chip sensors are subject to ageing and so must be changed regularly.
Pay attention to the storage conditions and the expiry date on

the packaging.
TIP
Check chip sensors regularly with appropriate control

solutions. A change of sensors must happen at least every 60
WARNING! days.
We recommend using EasyCon and EasyCon Pat for

the daily check, as well as the sensor test solution
TIP for checks on the chip sensors (see pt. 16 – p. 45).
Only change the sensors when the device is connected to the

power.
WARNING!

Procedure:
Connect the device with the power. When setting up for the first time or
when there is no chip sensor, the message "No sensor found"
appears. Now open the sensor lid in the following way:
Figure 5 Figure 6
• Press down the lid on the open side

(see Figure 5).
• Lid is now open (see Figure 6).
• Push lid further up from below until
the sensor lid opens completely
(see Figure 7).
Figure 7
Figure 8
View of opened
sensor cells and
sensors

• Do not touch the electric contacts.
• Do not allow any damp on the electric contacts.
WARNING! • Carefully wipe off damp on the flow cell and the sensor
holder with a lint-free cloth.
• Push the sensor into the sensor holder as shown in
Figure 8 and Figure 10. The arrow facing you must be
on the back and point in the direction of insertion.
• If the sensor is inserted incorrectly and the sensor lid is
pushed down by force, the result will be at least the
destruction of the sensor.
• Hold the sensor only as shown in Figure 9. Do not touch
the area with the truncated corner!
Figure 9 Figure 10
• Push the sensor into the sensor holder as far as it will

go, see Figure 11
• Next close the sensor lid and press the lid down at the
point marked closed, see Figure 12, until it audibly
engages.
Figure 11 Figure 12
If required this procedure can be repeated for the second measuring

channel.

When all measuring channels have been equipped correctly,
the "Sensor change" window appears.
Here you must enter for each newly inserted sensor whether it is “new“ or
“used“. It is very important to make a correct entry, as the device carries
out different entry procedures for the two types. Sensors count as “used“
when they have already been inserted into the device, and were then
removed and correctly stored.
If a sensor is removed for later use, it must be stored correctly

(see storage conditions on packaging). This procedure must not
TIP be repeated more than twice per sensor.
After each sensor change the device requires a period of time for sensor
conditioning. This time is shown in the display and counts down. During this
time the device is not ready for measuring.
6.2. Preparation of samples

The samples are collected via 20µl end-to-end capillaries and hemolysed in
a pre-filled micro test tube. This involves thinning the sample by 1:51.
Blood from the capillaries, venous / arterial blood, plasma or serum can be
used as sample material.
Errors in capturing and preparing the samples lead directly to

incorrect measurements. Please pay attention to the
WARNING! following instructions.
Taking samples from capillary blood:
• Clear, disinfect and dry the site of the aspiration. Remnants of

sweat and disinfectant solution can distort the measurement.
• Squeeze out a drop of blood which is large enough to fill the
capillary on its own. Fill the capillaries according to Figure 13-a.
a - View of a correctly filled capillary

b - View of a capillary which contains air bubbles
and is not filled to the end. This capillary must be
discarded.
c - View of a capillary with excess blood at the end.
This capillary must be wiped down carefully, see
Figure 14. The capillary must at the same time
remain full.
Figure 13

Figure 14 Figure 15
• Insert the capillary into a pre-filled micro test tube, close it securely
and shake it approx. 10 times. The capillary must be fully emptied
and the hemolysis solution must have coloured it evenly, see
Figure 15. The sample can now be measured.
When opening or closing the micro test tube make sure that
you do not splash or spill any of the solution. The result would
WARNING! be an incorrect measurement.
Taking a sample of venous/ arterial blood, plasma and serum:
• Using a pipette, lay a drop of sufficient size onto a base of clean,

non-soak material, e.g. PE film.
• Fill the end-to-end capillary according to the previous directions.
• Insert the capillary into the pre-filled micro test tube according to
the previous directions.
The sample can also be taken up directly with a 20µl pipette

and placed in the pre-filled micro test tube. For this a very
TIP accurate pipette must be available, and it can only be attempted
by someone with the appropriate experience.
6.3. Calibration solutions

The device must calibrate itself with the help of a solution
(standard) with a known concentration. All measurements are
related to this calibration. Hence high demands are made on the
concentration and stability of this solution.
This standard solution can be obtained from EKF-diagnostic GmbH
in ready-to-use form as a consumable product (see pt. 16 – p. 45).

• Keep to storage conditions and expiry date.
• Use opened micro test tube for a maximum of 8 hrs
WARNING! and then do not use them again.
• Do not combine the contents of opened
micro test tubes.
6.4. Control solutions

To carry out a quality control of the device various control materials can be
used. Normally control materials are treated like samples, i.e. they are
taken up using end-to-end capillaries and thinned in the micro test tube
pre-filled with hemolysis solution. EKF-diagnostic GmbH offers a variety of
control materials, including ready-to-use samples (pre-thinned). Further
notes can be found in pt. 16, p. 45.
6.5. Fitting of samples

The basic fitting arrangement for samples can be seen in Figure1, p. 7.
• The standard positions STD1 and STD2 can be

equipped in any way, including together.
TIP • Micro test tubes which have been inserted are
automatically recognised and taken up. No difference
is made between empty and full micro test tubes.
6.6. Barcode (optional)

The optional barcode scanner reads barcode labels of samples. In
standard, control and STAT positions the barcode cannot be read.
6.6.1. Barcode format

All usual barcode formats are supported, with a maximum of 12 characters.
The length of the barcode must be correctly set under the “barcode“ menu
option (see pt.10.9– p.31). A barcode test can be carried out under the
"Device control" menu option (pt. 10.12.3 – p. 33).

6.6.2. Specification of the barcode label
Example of a correct barcode

label. The name is optional.
* if the name does not appear
then the borderline and the upper
empty area of 4mm need not
appear, hence the barcode can be
extended.
Figure 16
• The gap between the barcode and the upper edge of the sheet
must be at least 7mm.
• The gap between the barcode and the lower edge of the sheet
must be at least 4 mm.
• The barcode must be at least 12mm wide.
• The label dimensions must not exceed 35 x 30.
6.6.3. Positioning of the barcode label
Figure 17
• The label must be stuck vertically and without folds.

• Stick the label sideways to the hinge.
• The label must not come off, particularly in the upper area, hence
press it on firmly.

7. Measurement operation
7.1. “Ready to measure” display window
Figure 18
Status text: Describes the current state of the device. (e.g. ready, in
calibration, in Stand-by etc.)
Advice text: This field is normally empty. When required it is used to
display messages
(e.g. surrounding temperature too high, etc.)
This display window is the ready window of the device. From here all of the
device‘s functions can be accessed.
The message "with calibration" can vary depending on the
calibration mode selected.
• You can find the individual symbols and their

meanings listed in pt. 5.1, p. 11.
TIP • If the status window displays the message "Ready
with (new) calibration", the next time
measurement is started (even STAT measurement) a
filled standard micro test tube is required in position
Std1 or Std2.

7.2. Sample measurement
The measuring can be started by pressing the Start button. Depending on
the calibration mode selected (see pt. 10.3.1 – p. 27) either the calibration
of the device comes first and then the sample measurement, or the sample
measurement takes place straight away. This mode can be set in the
Menu under "Calibration mode". The following figure shows the
“Measurement“ display window.
Figure 19
Tray no.:
The current tray number, this is raised by 1 every time measurement starts.
This can be pre-allocated in the menu, and is automatically set to 1 with
every cold start or change of date (at midnight).
Tray position:
This is always 1 for sample measurements. In calibration or controls /
STAT the corresponding position is displayed.
Measurement channel 1:
This displays the results for the parameter in measurement channel 1 (in
the example above this was the glucose measurement).
"+" or "-" next to the unit designates a value higher or lower than the
warning limits set. In the example above the glucose measurement
exceeds the upper warning limit (this can be set under the “Warning limits“
menu option).
"+++" or "---" instead of a value indicates a value higher or lower than the
measurement range (see technical data, pt. 15–p.43).

Measurement channel 2:
This displays the results for the parameter in measurement channel 2 (in
the example above this was the lactate measurement).
"+" or "-" next to the unit designates a value higher or lower than the
warning limits set. In the example above the glucose measurement
exceeds the upper warning limit (this can be set under the “Warning limits“
menu option).
"+++" or "---" instead of a measurement indicates a value higher or lower
than the measurement range (see technical data, pt. 15– p.43).
Barcode (optional):
Gives the barcode read for this sample position.
Serial sample number:

Serial numbering of the measurement tests, the STAT and the control
tests. Each type of test has its own circle of numbers which can be pre-
allocated respectively. These circles of numbers are set to 1 with each cold
start and with each change of date (at midnight).
A star next to the serial test number indicates that this

measurement is a double check of the current test, a setting
TIP which can be made under the "Warning limits" menu
option.
7.3. Controls
In principle control samples can be measured in any position (apart from
standard positions). However, internal device handling is set for the
positions C1 and C2.
Measurement of controls:
• Basically all equipped control positions are measured and

evaluated after every successful calibration.
• The control value limits, as well as the action taken when these
limits are exceeded, can be set under the “Warning limits“ menu
option.
• The device display during control measurements corresponds to
the display for sample measurement, Figure 19 – p. 23.
Difference: C1 or C2 appear instead of tray position.
If control measurements are not desired after every calibration,

the controls must be removed from C1 and C2!
TIP

7.4. STAT
STAT are automatically recognised by the device. A STAT, when
set, is designated by a tick on the STAT button, and is processed
as quickly as possible. Once the STAT has been processed the
tick is deleted again. If the STAT has to be processed again, the STAT
button should be pressed. The STAT button only has any effect when a
micro test tube is in the STAT position. A STAT can also be measured in
the "Ready" state. Depending on calibration mode, in some cases no
calibration takes place.
8. Memory
The memory can be called up in the states “Ready” and “Measurement”.
The following figure shows the "Memory" window.
Figure 20
The information displayed is identical with pt. 7.2 – p. 23, and is explained
there. The following provides some further details.
Tray no. / Position:
• Successful calibrations are designated with "Std". The

measurement displayed is the expected concentration and must
agree with the concentration given on the standard packaging.
• Measurements in the special positions C1 and C2 are designated
with "C1" or "C2".
• STAT measurements are designated with "STAT".

Previous / next tray:
The display changes to the previous or next saved value without displaying
calibrations or controls.
9. Info Menu
The Info Menu contains 4 windows which can be reached via the
arrow keys and which contain important information about the
device in a brief format.
10. Menu
The Menu can be called up at any time, apart from in the
measurement state (see pt. 7.1 – p. 22). All settings are retained
in the event of a power cut.
10.1. Stand-by
The device is put into Stand-by mode. The device can be activated again
with the warm start button (pt 5.1, p. 11_ff).
10.2. Numbering
All current meter readings described can be viewed in the Info

Menu, in the "Info" window.
TIP
10.2.1. Sample positions

Setting of the current tray number and the serial test number (if required).
The tray number is raised by 1 with every measurement start.

The test number is raised by 1 with every sample
TIP measurement.
10.2.2. Special positions

Here serial numbers for control-1(C1), control-2(C2) and STAT can be set if
required.
For each special position there is a separate number circle which is raised
by 1 with each measurement in this position.

10.3. Device settings
10.3.1. Calibration mode

There are 3 calibration modes which can be set:
• "By starting"
A calibration takes place first before every measurement. Controls
set are measured and evaluated. This also applies to STAT
measurements. In the "Ready" window the following is always
displayed:
"Ready with calibration"
• "Periodic"
The device calibrates itself automatically every 60 min. At
measurement start the samples (including STAT) are measured
immediately. In the Ready to measure window the following is
displayed: "Ready calibration in xx min", where xx
stands for the time until the next automatic calibration. If the
calibration time runs out while samples are still being measured,
the sample measurement is interrupted, calibration is executed
and the sample measurement continues (after successful
calibration). If a calibration was not successful (e.g. empty
standard micro test tube), an error message appears (this needs to
be confirmed) and the device changes to the ready to measure
state.
The display now shows
"Ready with new calibration".
At measurement start a calibration now takes place.
• "Time account"
The device is ready to measure for 60 minutes after a calibration.
After measurement start the samples (including STAT) are
measured straight away. In the Ready to measure window the
following is displayed:
"Ready xx min without calibration ".
Once the 60 min have elapsed calibration does not take place
automatically. The “Ready” window displays "Ready with
calibration". At the next measuring start a calibration takes
place again.
10.3.2. Sensor selection

This is only possible with a device with two measuring channels and two
active sensors.

Either one of the two chip sensors installed can be deactivated.
"Sensor 1" indicates measuring channel 1, and "Sensor 2" indicates
measuring channel 2, see also Figure1 – p. 7.
Please note the following:

• The life of a chip sensor is not extended by deactivation.
• A blind sensor, when inserted, deactivates the measuring
TIP appropriate channel automatically.
• With measuring channel 2 (sensor 2) deactivated, the
measuring time is shortened by approx. 8 seconds.
• With measuring channel 1 (sensor 1) deactivated the
measuring time is only shortened by approx. 4 seconds.
10.3.3. Units
The unit desired can be selected separately for each measuring channel.
10.3.4. Test type

This menu option has no effect at present.
10.4. Warning limits
10.4.1. Samples
Setting of warning limits for sample measurements, for both measuring
channels. The range in which the sample measurements are expected to
fall can be entered via the upper and lower limits. If the sample
measurements are above or below this limits, a "-" or "+" is displayed
next to the value displayed.
The limits which can be set are as follows:
glucose 0,5mmol/l ( 9mg/dl ) – 50mmol/l ( 900mg/dl )
lactate 0,5mmol/l ( 9mg/dl ) – 40mmol/l ( 720mg/dl )
10.4.2. Control 1
Here the special position C1 is evaluated, otherwise the procedure is
identical to pt.10.4.1. The upper/lower limits must agree with the permitted
limits of the control material used.
10.4.3. Control 2
Here the special position C2 is evaluated, otherwise the procedure is
identical to pt.10.4.1. The upper/lower limits must agree with the permitted
limits of the control material used.

10.4.4. Breach of limits
These settings control how the device should proceed when set limits have
been breached.
• "Controls – continue measurement?"

If set limits have been breached in Control 1 (C1) or Control 2 (C2),
measurement of the samples (tray) can be aborted or continued.
• "Samples – double determination?"
If set limits have been breached during sample measurement, a
second measurement of this sample can be carried out (double
check).
10.5. Date / Time

Date and time settings.
10.6. Selecting printer type

At present the serial DPU 414 printer is available.
10.7. EDP
This menu option contains all relevant parameters for connecting the
device with the hospital computers. Changes should only be made by
informed personnel.
10.7.1. Transfer protocol

Here the structure of the transfer protocol can be set. At present the
"BIOSEN" protocol is supported. For protocol structure see also
pt. 11.2.2 – p. 35.
10.7.2. Transmission parameters

Adjustable Baud rates and parameters (length, start/stop, parity)
Possible Baud rates: 1200, 2400, 4800, 9600
Possible parameters: 8, 1, Even 7, 1, Even 7, 2, Even

8, 1, Odd 7, 1, Odd 7, 2, Odd
8, 1, No 7, 1, No 7, 2, No

10.7.3. Preamble / Postamble
Adjustable start and end identification code of the data protocol.
Possible preambles:
{CR}, {CR LF}, {STX}, {STX CR}, {STX CR LF}, {STX DEL}
Possible postambles:
{CR}, {CR LF}, {ETX}, {CR ETX}, {CR LF ETX}, {DEL ETX}
10.7.4. Device identifier

Setting of the name which the device uses to identify itself to the computer.
The name is transmitted in the first part of the data protocol
(see pt. 11.2.2 – p. 35).
Possible device identifiers: 5030, 5040, 5130, 5140, BIOS, 6664,

EBIO, CARE, SG01, SGL2.
Moreover, a device number between 01 and 99 can be assigned.
10.7.5. Method number

Method numbers can be assigned for glucose in hemolysate and in serum,
as well as for lactate in hemolysate and in serum. These numbers are also
transferred into the data protocol. Since at present the device does not
distinguish between hemolysate and serum, the respective hemolysate and
serum method numbers should be the same.
Method numbers can be set between 000 and 999.
10.7.6. Request operation

This setting controls whether the device sends each new measurement to
the computer immediately, or does so only on request. A request is a
logical "1" signal at the device‘s RxD inlet.
Only the most recent measurement can be requested. If several
measurements take place between two requests, they are lost.
TIP The setting to be preferred is without requests (no tick).
10.7.7. Sending a test telegram

This menu option is for testing the computer setting selected. A data
telegram is sent to the computer.

10.8. Region
• "Language"
Here the desired language can be set.
• "Format"
Here the format of date and time can be selected.
•
The power frequency must also be set. This setting has
an effect on the measurement precision, and must be
WARNING! correct. In case of doubt ask your house technician or
dealer.
10.9. Barcode
The barcode can be activated or deactivated. The barcode length used is
also adjustable. For reliable barcode recognition the barcode length used
must be set correctly. The length can be adjusted between 0 and 12, where
0 corresponds to a setting with variable barcode length (this setting is not
recommended).
10.10. Servicing the device
10.10.1. Cleaning/ disinfection

In order to maintain the high precision of measurement, it is recommended
that the flow system of the device should be treated with a cleaning solution
approx. every 3 months. This cleaning solution should be obtained from
EKF-diagnostic GmbH (see pt. 16 – p. 45) and prepared according to the
instructions enclosed in the packaging. Next you should place the micro
test tube in position C1 and follow the instructions on the display.
Warning: all chip sensors situated in the device are destroyed

by this process. You should only carry out this procedure if the
WARNING! sensors need to be changed anyway. Old or blind sensors
must be contained in all measuring channels.
10.10.2. Empty system

With this function the flow system can be fully emptied, which is important
when the device needs to be stopped for long periods of time
(see pt. 12 – p. 36).

10.11. Menu types
The following menu types are available:
• "Complete"
Here the complete array of menu items is available.
• "Routine"
For the sake of easier handling in daily routine, the following
greatly-reduced Menu is offered:
"Stand-by" (see pt. 10.1 – p. 26)
"Numbering" (see pt. 10.2–p.26)
"Warning limits" (see pt. 10.4– p.28)
"Menu type" (see pt. 10.11 – p. 32)
10.12. Extras
10.12.1. Contrast / Tone

Here display contrast and tone can be set. Normally a contrast value of 50
is a good mid-range value, but with higher or lower surrounding
temperatures changes may be necessary.
When changing the contrast, tap the arrow keys rather than holding them
down, as otherwise the display becomes much too dark or much too light
very quickly.
10.12.2. Histories
Here the device writes down important internal events of the most recent
weeks of operation. You can navigate using the arrow keys.
• "Calibration"
All calibration measurements of the last 4 – 8 weeks are listed
according the following scheme:
"Date – Time – Channel 1 – Channel 2"
• "Error"
All errors of the last 4 – 8 weeks are listed according to the
following scheme:
"Date – Time – Error code"
The error code is only of importance for service personnel.

10.12.3. Device control
• "Reset to factory settings"
When the command is given the device resets all parameters
which can be set in the menu back to factory default settings. The
WARNING!
device can measure, but the computer transmission and the
barcode may no longer work.
• "Barcode test"
A test is carried out to determine whether the device can correctly
read the barcodes used, and whether barcode stickers have been
stuck on the sample tubes correctly (see pt. 6.6.3 – p. 21).
For this the sample tube is put into the sample position and the test
is commenced. Further directions appear in the display.
10.13. Contact
Here you can find a contact for any questions which may come up.
11. Connection to other devices

See Figure 2 – p. 8 for the position of the interfaces.
11.1. Protocol printer
11.1.1. Serial printer

For serial protocol printing, printer type DPU414 is used exclusively. The
connection to the device is made via a serial printer cable. Normal printer
cables are not compatible. Printers and cables can be obtained from EKF-
diagnostic GmbH (see pt. 16 – p. 45).
The printer software switches are normally pre-set correctly. If printer
problems arise they should be checked (see also the manual for the DPU-
414 printer):
SW1 SW2 SW3

1-OFF 1-OFF 1-ON
2-OFF 2-ON 2-ON
3-ON 3-ON 3-ON
4-OFF 4-ON 4-ON
5-ON 5-ON 5-OFF
6-OFF 6-ON 6-ON
7-ON 7-OFF 7-ON
8-ON 8-ON 8-ON

The device has a serial printer interface according to V.24
Standard. By contrast with standard interface allocation,
WARNING! only TxD and DSR are assigned. Please keep to the following
interface assignment.
Pin Assignment
3 TxD
6 DSR
5 GND
11.1.2. Parallel printer

The device is prepared for the connection of A4 standard printers with
Centronics interface. This interface will be used at a later point in time. Find
out more from your dealer or from EKF-diagnostic GmbH.
11.2. EDP connection

Under the "EDP" menu option (see pt. 10.7– p.29) all parameters for data
exchange can be set.
11.2.1. Connector pin assignment

The device has a serial interface according to V.24 Standard.
By contrast with standard interface occupancy only the
WARNING! transmission and reception connections (TxD, RxD) are
occupied. Please keep to the following interface assignment.
Pin Assignment
2 RxD
3 TxD
5 GND

11.2.2. Structure of data protocol
Field name Description Length Content
PREAMBLE Start of data block 1 to 4 see pt. 10.7.3 – p. 30
DEVID Device identifier 4 see pt. 10.7.4 – p. 30
DEVNO Device number (00-99) 2 see pt. 10.7.4 – p. 30
SEL Selector 1 D
TYPE Test type 1 P = Patient
Q = Control
S = STAT
SAS Sample assignment 4
for Type = P Tray number / Position 0213 (Tray 2 / Pos 13)
for Type = Q Control position C1 0001 (fixed)
for Type = Q Control position C2 0002 (fixed)
for Type = S Quick test position STAT 0000 (fixed)
NOM Number of measurement 12
With barcode deactivated: 000-999 +9 spaces
Separate numbering for
Type: P,Q(1),Q(2), S
With barcode activated, 1 - 12 characters filled
Type = P and barcode with read barcode
read successfully
With barcode activated 1 - 12 characters filled
and barcode reading error with spaces
or Type = Q or Type = S
MET Method number 3 see pt. 10.7.5 – p. 30
DATE Date of measurement 8 DD.MM.YY
TIME Time of measurement 5 HH:MM
RES Result of measurement 6 ###.##
##.## +1 space
#.## +2 spaces
UNIT Selected unit 6
mmol/L mmol/L
mg/dL 1 space + mg/dL
RFL Results flag 1
no error 0
>= warning limits for samples 1
<= warning limits for samples 2
>= warning limits for controls 3
<= warning limits for controls 4
>= measurement range 5
<= measurement range 6
MC Measuring channel 1
Channel 1 (sensor 1) 0
Channel 2 (sensor 2) 1
POSTAMBLE End of the data block 1 to 4 see pt. 10.7.3 – p. 30

• With each measurement a complete data telegram is transmitted per
measuring channel. The distinction between them is made via the
telegram field MK. Hence for a 2-channel device two data telegrams
are transmitted with a gap of approx. 1000ms.
• Warning: if one measuring channel is switched off on a 2-channel
device, from that point on only one data telegram per measurement
is transmitted (important for the computer).
12. Putting out of service
12.1. Explanation
The device contains a flow system and a sensitive biochemical

chip sensor. You are strongly advised to leave the device
WARNING! continually connected to the power supply. The following
problems can occur when the device is removed from the
power supply without taking the necessary precautions:
• Chip sensor stability

After every power cut the chip sensor needs a new warm-up period
in order to stabilise.
• Flow system
If the device is separated from the power supply for more than
approx. 72 hrs, the system solution crystallises entirely. This may in
some cases lead to the flow system becoming congested.
• Tube
If the device is separated from the power supply for longer than 72
hrs, the tube may in some cases become stuck such that it can no
longer be used for transportation.
If the device is not required any more, it should be switched to

"Stand-by" mode. This reduces consumption of energy and
TIP system solution to a minimum.
12.2. Brief separation from power supply (< 72 h)

For the purpose of dispatch or transport, the device can be removed from
the power supply for a maximum period of 72 hrs without additional action.

The containers for system solution (buffer) and waste must be
emptied. Additionally all micro test tubes must be removed.
WARNING!
12.3. Longer separation from power supply (>72 h)

If measurement is only to stop for a few days, for the reasons
above it is better to keep the device in stand-by mode. Only
TIP if no measurements are planned in the next 4 weeks is a
complete putting out of service advisable.
Procedure:
• Select "Emptying System" option and execute
• Empty bottles containing system solution and waste
• Empty samples and special positions
• Remove chip sensor(s)
• Hang the tube externally in the following way:
Figure 21 Figure 22
• If possible, hold with a rounded pair of tweezers and hang over the
pump wheel. Next close the pump flap again.
The tube must not be completely removed!
• Remove the device from the power supply.
13. Servicing the device
13.1. Cleaning and disinfection

In the cleaning and disinfection of the device a distinction is to be drawn
between normal surface cleaning and disinfection and cleaning and
disinfection of the flow system.

Cleaning / disinfection of the device:
• For cleaning and disinfection use a common alcohol-free cleansing
agent which is common in the trade.
• You should only clean the external surfaces of the device using a
cloth which has been dampened with this cleaner.
• Do not clean the interior of the sensor cell (see Figure 8- p.16), and
in particular do not clean the electric contacts. The flow cell can be
cleaned carefully with a lint-free cloth.
• You should wipe the display only with a moderately damp cloth. You
should remove the bottle with system solution beforehand, so that no
buttons are pressed through the action of cleaning.
Cleaning / Disinfection of the flow system:

• Cleaning the flow system is recommended approx. every 3 months
(see pt. 10.10.1 – p. 31).
• Disinfection of the flow system is recommended before the
maintenance parts (sample cannula, exchanger or tube) are changed
(see pt. 10.10.1 – p. 31).
• Only cleaning and disinfectant solution from EKF-diagnostic GmbH
may be used (see pt. 16 – p. 45).
Warning, the chip sensors are destroyed by these solutions.
WARNING!

13.2. Maintenance parts
Warning! There is a danger of infection when changing the

maintenance parts!
WARNING!
13.2.1. Pump tube

The tube should be changed in a 6-month cycle.
Procedure:
• Hang the tube externally according to Figure 21, Figure 22 – p. 37

and pull the ends of the tube out of the pump connections.
• Insert the new tube into both pump connections first (this is easier
when both tube ends are first slightly dampened with system
solution). You should pay attention to the red markings on the tube
and the pump: see Figure 23, Figure 24– p.39.
• Press the tube ends as far as they go into the pump connection: see
Figure 23 – p. 39.
• As shown in Figure 24 – p. 39 you should lay the tube at the stopper
into the duct and push it as far as it goes (until there is a notch in the
duct).
• Hang the tube externally again according to pt. 4.5– p.10.
Figure 23 Figure 24

13.2.2. Exchanger and sample cannula
The exchanger should be changed in a 6-month cycle. The sample cannula
should be changed in a 12-month cycle.
Procedure:
• Empty the tube system (see pt. 10.10.2– p.31).
• Pull the tube away from the sample cannula and loosen the fastening
screws, see Figure 25.
• Pull out the sample cannula, see Figure 26.
Figure 25 Figure 26
• As in Figure 27 turn the exchanger at the tube connection until it is at

right angles to the pivot and then pull it out forwards.
• Pull the exchanger out of the tube and put on a new exchanger.
Push the tube as far as it will go, see Figure 28.
Figure 27 Figure 28
• Construction is in the opposite order. You should turn the exchanger-

tube connection in the direction of the pivot arm until you can feel it
engage.

14. Troubleshooting
Error message Explanation and rectification

HMIC default parameter
System error, ask for service personnel, no measurement possible
has been loaded
PIC is unknown System error, ask for service personnel, no measurement possible
HMIC CRC Code of
System error, ask for service personnel, no measurement possible
ROM is wrong
PIC does not response System error, ask for service personnel, no measurement possible
System error – with error
number and without System error, ask for service personnel, no measurement possible
confirmation
System error – with error
Non-critical system error, measurement operation is possible again
number and with
after confirmation
confirmation
This error occurs after removal from power supply, after change of
sensor or during operation, and cannot be confirmed. The current
sensor currents are shown in the window and are refreshed approx.
every 50 seconds by the device. The sensor currents must drop to
below a certain value for the device to automatically return to
readiness to measure. The following are possible causes:
• The device has been removed from the power supply for several
hours or days (e.g. for transport)
⇒ The chip sensor needs to become stable again. Leave the
Sensor current too high device in this state until it automatically goes into readiness to
measure
• The chip sensor has just been changed
⇒ The chip sensor needs to become stable. Leave the device in
this state until it automatically goes into readiness to measure
• The chip sensor is faulty or too old
⇒ Change the chip sensor
• The system solution is used up or is unsuitable
⇒ Add fresh system solution
The device wants to calibrate itself at the start of measurement or
automatically and cannot find any standard micro test tube, or the
standard micro test tube inserted has been designated as empty.
No standard ⇒ Insert standard micro test tube
⇒ Replace empty standard micro test tube with a full one
⇒ Remove standard micro test tube briefly and insert it again
After each action begin measurement again.

The minimum required calibration value has not been reached. The
following are possible causes:
• The standard micro test tube is empty
⇒ Exchange standard micro test tube
• Incorrect or unsuitable standard
⇒ Use a new original standard micro test tube, if possible from new
Calibration value
packaging
sensor1(2) too low
• The chip sensor is faulty
• The flow system leaks. Exchanger, cannula or tube are worn or
faulty
⇒ Check the tube system and if necessary change the exchanger
or the tube
The maximum permitted calibration value has been exceeded. The
following are possible causes:
• An incorrect or unsuitable standard
Calibration value
⇒ Use a new original standard micro test tube, if possible from
sensor1(2) too high
different bag
• The chip sensor is faulty or too old
Even after 5 tries the required precision in calibration has not been
attained. The following are possible causes:
• Incorrect or unsuitable standard
⇒ Use a new original standard micro test tube, if possible from
different bag
• The flow system leaks. Exchanger, cannula or tube are worn or
Calibration value faulty
sensor1(2) instable
⇒ Check the tube system and if necessary change the exchanger
or the tube
• The system solution is unsuitable
⇒ Add fresh system solution
• Chip sensor is faulty
No chip sensor fitted in devices with a measuring channel.
⇒ Insert chip sensor
No sensor found No chip sensors or only one chip sensor fitted in devices with two
measuring channels
⇒ Insert a second chip sensor or a blind sensor
The system solution bottle is empty.
No system solution
⇒ Fill the bottle with system solution
Waste bottle is full ⇒ Empty the waste bottle
The pump does not turn correctly. The following are possible causes:
• The tube is not inserted correctly
Pump error, pump is
⇒ Examine the position of the tube
blocked
• Faulty pump
⇒ Ask for service personnel

The pivot arm was blocked in its movement and was unable to reach
its position.
Pivot arm error, pivot ⇒ Remove the cause and confirm error with ok.
arm is blocked The device tries to remove the error and if it manages goes into
readiness to measure. If the attempt is not successful, the device
returns to the error message.
The lifter was blocked in its movement and was unable to reach its
position.
Lifter error, lifter is ⇒ Remove the cause and confirm error with ok.
blocked The device tries to remove the error and if it manages goes into
readiness to measure. If the attempt is not successful, the device
returns to the error message.
15. Technical data

Measurement principle Enzymatic/ amperometric
Electrode Chip sensor
Measurement range glucose: 0.5-50 mmol/L (9-900 mg/dL)

lactate: 0.5-40 mmol/L (5-360 mg/dL)
Accuracy CV ≤ 1.5% at 12 mmol/L
Stability (drift) ≤ 3% over 10 tests, based on 12 mmol/L
Lifetime of the sensor glucose: 60 days or 7500 tests
(on average) lactate: 50 days or 6000 tests
Sample material Blood, plasma or serum
Sample volume 20 µL (10 µL)
Reaction vessels 1.5 ML or 2.0 ML micro test tubes
Ambient temperature +15 to +35 °C
during operation
Storage temperature device: -20°C to + 50°C
glucose sensor: +4°C to +8°C (fridge)
lactate sensor: -18°C (deep freezer)
Relative Air humidity 20 – 85 %
Mains power 100 – 230 VAC / 50 – 60 Hz
Power consumption ≤ 20 VA (according to specification)
Dimensions (LxWxH) 280 x 280 x 95 mm
Weight approx. 3 - 5 kg (according to specification)
EDP RS 232C (V.24) interface
Printer Parallel interface, RS 232 C (V.24)
Display / keyboard Graphic touchpanel (320 x 240 Pixels)
Memory 500 readings with position, date and time
Languages German, English, Russian, other languages on
request

16. List of consumables and maintenance parts
Sensors
Order number Description Notes
5206-3011 Chip sensor glucose type II For C_line
5206-3029 Chip sensor lactate type II For C_line
5206-3135 Dummy sensor For C_line
Standard solutions – for calibration, ready-to-use

50 x 2ML
5211-3015 Multi-Standard 12mmol/L
micro test tubes
100 x 2ML
micro test tubes
1 x 50ML
bottle
Sensor test solutions– for regular testing of the sensors, ready-to-use.

Sensor test solution 20 x 1ML
5130-6055
for glucose / lactate micro test tubes
Each contains
Set Linearity Test for
0209-0102-391 3 x 1ML
glucose / lactate, (2-7-18mmol/L)
micro test tubes
Control solutions – for quality management according to RiliBäk, in

other words for regular device checks.
EasyCon control solution,
6 x 1ML
0201-0005-012P6 for glucose and lactate
micro test tubes
(for thinning in test tubes)
EasyConPAT control solution,
6 x 1ML
0201-0005-013P6 for glucose and lactate
micro test tubes
(for thinning in test tubes)
ReadyConnorm test serum,
25 x 1ML
5130-6152 for glucose and lactate
micro test tubes
(thinned 1:51 ready to use)
Control solution ReadyConPAT,
25 x 1ML
5130-6162 for glucose and lactate
micro test tubes
(thinned 1:51 ready to use)

Pre-filled micro test tubes – for taking of samples, ready to use
Glucose/lactate-hemolyzing 200 micro test
0209-0100-013 solution with tubes a 1ML
20µL end-to-end capillaries 2 x 100 capillaries
Glucose/lactate-hemolyzing 5 x 200 micro test
Glucose/lactate-hemolyzing 1000 micro test
System solution – ready to use

0201-0002-025 Glucose/lactate system solution 0.5L bottle
0201-0002-024 Glucose/lactate system solution 2.5L canister
0201-0002-026 Glucose/lactate system solution 5.0L canister
Printer
5211-7012 DPU 414Thermal printer Protocol printer, serial
Thermal paper for DPU 414
0203-0100-204 5 rolls
Thermal printer
Printer cable for DPU 414 Cable connecting
0720-0100-003
Thermal printer printer to the device
0750-0100-002 Battery pack for DPU 414
Mains adapter for Thermal
0711-0600-001
printer
Cleaning and disinfection

for cleaning and disinfection of the flow system (every 3 months) and when
changing the tube, sample cannula or exchanger.
0201-0003-001 Disinfectant solution 5 x 100µL
(not ready to use) micro test tubes
0201-0004-001 Cleaning solution 5 x 30µL
(not ready to use) micro test tubes

Maintenance parts
5208-1094 Pump tube Change every 6 months
5211-1735 Exchanger Change every 6 months
5211-1719 Sample cannula Change every 12 months
Bottle connector for 200ML
5211-1383 Lid with tube connection
bottle system solution
Bottle connector for 200ML
5211-1391 Lid with tube connection
bottle waste
Accessories
5212-1815 Sample tray for C_line Sport Only for C_line Sport
5214-1811 Sample tray for C_line Clinic Only for C_line Clinic
Sample holder for C_line
5213-1820 Only for C_line GP+
GP+
5211-8019 Aluminium transport case For C_line
5211-7209 Car adapter 12V / 230V
Connecting cable
0720-0100-012 EDP cable between EDP and
BIOSEN, 3m long
0901-0200-002 Capillary holder For end-to-end capillaries
For setting down micro
0690-0200-101 Stand
test tubes
Thermo-transport box made
0901-0200-001 For 100 micro test tubes
of Styrofoam
0204-0700-211 Lancets Quantity 200
0204-0700-212 Lancets Quantity 500
7201-3071 Cellulose swabs 4 x 5 Quantity 2 x 200

17. Theoretical principles
The measurement of glucose and lactate is based on an electro-chemical
measuring principle with a chip sensor specially developed for this purpose.
The sample is automatically collected by the device and led into the
system. Here the ß-D glucose / L-lactate contained in the sample is
converted enzymatically with the help of the immobilised enzyme glucose
oxidase / lactate oxidase. The products of the reaction are gluconic acid/
pyruvate and hydrogen peroxide. The hydrogen peroxide is detected at the
electrode.
Additionally it is important, indeed essential, for the sensor system to be
calibrated with a solution of known concentration. The current which results
is proportional to the glucose concentration. Unknown glucose
concentrations can be determined relative to this calibration. After each
measurement the chip sensor is automatically cleaned with a buffer
solution. This washes out the old sample substance. The sensor system is
then ready for the next measurement.
Amperometric
O2
Glucoce oxidase
: Current signal
H O - Determination
2 2
ß-D-Glucose + O2 + H 2O
D-Gluconic acid + H 2 O 2 2 H + + O 2 +2 e
H2O2
Glucose
Other substances in blood
Immobilised Amperometric
O2
Lactate oxidase
: Current signal
H O - Determination
2 2
L-Lactate + O2
Pyruvat + H2O2 H 2 O 2 2 H + + O 2 +2 e
L-Lactate
Other substances in blood

18. Statement of Conformity

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BIOSEN C_line

Phon.: +49 (0) 39203 / 785 - 0

Software-Version: HMIC-1.01.00 / PIC-1.01.00

BIOSEN C_line Clinic - operator`s manual -1-

-2- BIOSEN C_line-Clinic operator`s manual

BIOSEN C_line Clinic - operator`s manual -3-

2.1. Explanation of the symbols used

The DANGER symbol

The WARNING symbol

The TIP symbol

-4- BIOSEN C_line-Clinic operator`s manual

2.2.1. General notes

Follow the operator`s manual!

Danger of fatal electric shock!

Check whether the connection values given on the label

Do not operate the device in areas where there is a risk

Allow the device to reach room temperature!

BIOSEN C_line Clinic - operator`s manual -5-

2.2.2. Moving parts

-6- BIOSEN C_line-Clinic operator`s manual

1 Display with Touchpanel

BIOSEN C_line Clinic - operator`s manual -7-

4.1. Unpacking the device

• BIOSEN C_line device

4.2. Installing the device

Conditions at location of installation:

-8- BIOSEN C_line-Clinic operator`s manual

4.3. Electric power supply and interface

Do not connect the device yet – first further preparations must

The following accessory parts can optionally be connected to the device:

• Protocol printer, currently only DPU414 (serial connection) with

Further important instructions regarding the connection of the

4.4. Consumables required

• System solution – pour into the system solution bottle

BIOSEN C_line Clinic - operator`s manual -9-

4.5. Pump tube

The tube must be hung on again. A

4.6. Switching the device on and off

- 10 - BIOSEN C_line-Clinic operator`s manual

Separating the device from the power supply is only

• Only apply light pressure when pressing

In order to avoid undesired operation of the device when

5.1. Button symbols used

BIOSEN C_line Clinic - operator`s manual - 11 -

In the Menu, in sub-menus:

In the Menu, in sub-menus:

When ready to measure, during measurement operation:

When ready to measure, during measurement operation:

During measurement operation:

When ready to measure, during measurement

During measurement operation:

- 12 - BIOSEN C_line-Clinic operator`s manual

During the warm start:

5.2. Navigation and operation

• A position bar shows the currently selected menu option. If an

5.3. Device messages

Advice window – with corresponding instruction text

BIOSEN C_line Clinic - operator`s manual - 13 -