EKF Diagnostics Biosen C-Line Clinic User manual

User Manual
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User Manual
Biosen C-Line
Clinic / GP+
Biosen C-Line - Clinic / GP+

BIOSEN C_line
Clinic / GP+
Glucose/Lactate Measuring System
User Manual

This document is protected by copyright. It may not be reproduced or
distributed to third parties without the prior written consent of
EKF-diagnostic GmbH.
Subject to alteration. Errors excepted.
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben / Magdeburg
Germany
Phone: [phone]
Fax: [phone]
Manual revision:
Released: 2.02 01/2021

Contents
User Manual Biosen C_line Clinic / GP+
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0. Contents
0. CONTENTS .....................................................................1
1. IMPORTANT INFORMATION .........................................4
1.1 SAFETY NOTES ..............................................................4
1.2 ABBREVIATIONS.............................................................5
2. INTENDED USE ..............................................................6
3. DESCRIPTION OF DEVICE COMPONENTS.................7
4. DESCRIPTION OF TOUCH PANEL................................8
4.1 USED BUTTON SYMBOLS AND FUNCTION..........................8
4.2 NAVIGATION AND OPERATION .......................................10
4.3 DEVICE MESSAGES ......................................................11
5. SETTING UP..................................................................12
5.1 SETTING UP AND INITIAL START-UP................................12
5.2 PREPARATIONS FOR DEVICE OPERATION.......................13
5.2.1 Consumables.........................................................13
5.2.2 Pump tube.............................................................13
5.2.3 Chipsensor ............................................................14
5.2.3.1 Sensor insert ...Fehler! Textmarke nicht definiert.
5.2.3.2 Sensor replacement ............................................ 16
5.2.4 Switching the device on and off.............................17
6. SAMPLING ....................................................................19
6.1 TAKING A SAMPLE OF CAPILLARY BLOOD .......................19
6.2 OTHER SAMPLE MATERIALS ..........................................21
6.3 BARCODE (OPTIONAL,ONLY C_LINE CLINIC)..................22
6.3.1 Barcode format......................................................22
6.3.2 Specification of the barcode label..........................22
6.3.3 Positioning of the barcode label ............................23
7. MEASUREMENT OPERATION.....................................24
7.1 READINESS FOR MEASUREMENT ...................................24
7.1.1 Measurement control mode .................. ...............24
7.2 SAMPLE MEASUREMENT ...............................................25
7.2.1 Calibration .............................................................25
7.2.2 Sample preselection..............................................26

Contents
User Manual Biosen C_line Clinic / GP+
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2
7.2.3 Adjustment whole blood glucose/plasma glucose (optional)
26
7.3 RESULT SCREEN..........................................................28
7.4 QUALITY CONTROL.......................................................29
7.5 URGENT SAMPLES (STAT)...........................................29
7.6 MEASURED VALUE MEMORY..........................................30
8. INFO MENU...................................................................32
9. DEVICE MENU ..............................................................33
9.1 STAND BY....................................................................33
9.2 COUNTER PRESETTING.................................................33
9.2.1 Sample positions ...................................................33
9.2.2 Special positions....................................................33
9.3DEVICE SETTINGS ........................................................33
9.3.1 Calibration mode....................................................33
9.3.2 Sensor selection....................................................34
9.3.3 Unit ........................................................................34
9.3.4 Sample type...........................................................34
9.3.5 Sample preselection..............................................35
9.3.6 Tray identification ..................................................35
9.4 WARNING LIMITS..........................................................35
9.4.1 Samples.................................................................35
9.4.2 Control 1................................................................35
9.4.3 Control 2................................................................35
9.4.4 Range violation......................................................35
9.5 DATE /TIME.................................................................36
9.6 PRINTER TYPE .............................................................36
9.7 EDP............................................................................36
9.7.1 Protocol type..........................................................36
9.7.2 Interface parameter...............................................36
9.7.3 Preamble / Postamble ...........................................36
9.7.4 Device ID...............................................................37
9.7.5 Method number......................................................37
9.7.6 Request mode.......................................................37
9.7.7 Send test telegram ................................................37
9.8 REGION.......................................................................37
9.8.1 Language...............................................................37
9.8.2 Format...................................................................37
9.9 BARCODE (OPTIONAL,ONLY C_LINE CLINIC)..................38
9.10 MAINTENANCE .............................................................38
9.10.1 Cleaning / Disinfection.......................................38
9.10.2 Emptying system...............................................38

Contents
User Manual Biosen C_line Clinic / GP+
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9.11 MENU TYPE .................................................................38
9.12 OPTIONS .....................................................................39
9.12.1 Contrast / Tone .................................................39
9.12.2 Histories............................................................39
9.12.3 Device control ...................................................39
9.13 CONTACT ....................................................................39
10. ACCESSORIES AND CONNECTIONS ....................40
10.1 SERIAL PROTOCOL PRINTER .........................................40
10.2 EDP CONNECTION .......................................................41
10.2.1 Connector pin assignment ................................41
10.2.2 Structure of data protocol..................................41
11. SHUTDOWN..............................................................43
11.1 BRIEF SEPARATION FROM THE MAINS (<72H).................43
11.2 LONGER SEPARATION FROM THE MAINS (>72H).............43
12. MAINTENANCE ........................................................44
12.1 CLEANING AND DISINFECTION .......................................44
12.1.1 Cleaning and Disinfection of the device............44
12.1.2 Cleaning and Disinfection of the flow system....44
12.2 MAINTENANCE PARTS...................................................45
12.2.1 Pump tube.........................................................45
12.2.2 Exchanger and sample cannula........................45
12.3 DISPOSAL....................................................................47
13. TROUBLESHOOTING..............................................48
14. TECHNICAL DATA...................................................51
15. THEORETICAL PRICIPLES .....................................52
15.1 REFERENCE RANGES ...................................................52
15.2DESCRIPTION OF MEASURING PROCEDURE....................52
15.3 CALIBRATION...............................................................53
16. APPENDIX.................................................................54
16.1 REPLACEMENT PARTS AND CONSUMER MATERIALS........54
16.2 CONTACT ....................................................................56
16.3 SYMBOLS ....................................................................57

Important Information
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1. Important Information
1.1 Safety notes
The following symbols are used in this user manual:
This symbol warns of conditions or handling, which may in certain
circumstances lead to serious injury or even death.
This symbol warns of conditions or handling, which may in certain
circumstances lead to health impairments.
This symbol warns of conditions or handling, which may in certain
circumstances lead to damage to the device or consumables.
It is essential that you read the following notes in order to avoid risks to
persons and damage to the device and other equipment. The handling
of the device requires full understanding and strict observance of this
manual. EKF-diagnostic GmbH does not accept any responsibility for
damage arising from non-observance of the following notes.
The device processes samples of human origin. This
involves potential risk 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.
Danger of fatal electric shock!
Under no circumstances should you open the device. There are no
components inside which require servicing or maintenance. Repairs
must only be performed by authorized service staff.
Never use a mechanically damaged device.
An isolated ground receptacle is mandatory for operating the device.
Check whether the mains voltage and frequency printed on the type
label match your mains socket.
The device is not insulated against fluid ingress. Note
the maintenance instructions in section 12, page 44. If a fluid spillage is
suspected pull the mains plug immediately.

Important Information
User Manual Biosen C_line Clinic / GP+
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The device is not approved for use in areas where there
is a risk of explosion.
Only use the Biosen device for the purpose described in
section 2 on page 6. Observe the specifications for the use, storage and
transport of products.
Only use equipment and consumables, which are
expressly approved for use with the Biosen device.
The device should be subject to yearly inspections and
servicing. It is recommended to make a service contract. Repairs to the
device must only be performed by EKF-diagnostic GmbH or an
authorised service partner. For further maintenance instructions refer to
section 12, page 44.
The device has parts that can move unexpectedly during
normal operation. The occurring forces are designed to exclude any risk
of injury. In addition, the device has a mechanism which immediately
stops the appropriate component when blocked. Nevertheless, it is
recommended not to touch these parts during operation because the
device may immediately abort a running measurement operation.
1.2 Abbreviations
STD Standard
C1 / C2 Control 1 and 2
STAT Urgent sample
G Glucose
L Lactate
QC Quality control
IFCC International Federation of Clinical Chemistry and
Laboratory Medicine
Hct Hematocrit

Intended Use
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2. Intended Use
The Biosen C_line measuring system is intended to be used
for the quantitative determination of glucose and lactate concentration
in human blood, plasma and serum. It consists of a tabletop
device and the consumables, necessary for measurement.
The sample is taken up with an end-to-end capillary, hemolyzed
and diluted in a micro test tube, pre-filled with a hemolyzing solution and
then measured by the device.
The consumables must be disposed of after their use as
potentially infectious waste in accordance with the current regulations
applicable to your establishment
The Biosen C_line is a closed system and is intended for use in
medical practices, in clinical laboratories and wards to assist in
medical diagnostic investigations as well as for use in sports medicine.
Only qualified personnel with profound skills in
handling in-vitro diagnostic devices and this system should be
allowed to take blood samples and operate the Biosen C_line.
Use only original spare parts, consumables and test
materials approved by EKF-diagnostic GmbH for use with the BIOSEN
C_line.

Description of device components
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3. Description of device components
Figure 1 –Front view
Nr.
Description
C_line Clinic
C_line GP+
1
Display with touch panel
2
Tray for 20 samples,
removable
Tray for 5 samples,
removable
3, 4
Positions for standard 1 and 2 (STD1, STD2)
5, 6
Positions for control 1 and 2 (C1, C2)
7
Positions for urgent sample (STAT)
8
Exchanger (maintenance part)
9
Sample cannula (maintenance part)
10
Lifter
11
Pivot arm
12
Pump tube (maintenance part)
13
Pump with pump flap
14
Sensor lid measuring channel 1
15
Sensor lid measuring channel 2 (optional)
16
Opening for bottle of system solution
17
Opening for waste bottle
18
Waste bottle with lid, color code black + symbol Biohazard
19
Bottle for system solution with lid, color code red
20
Card reader
19
18
17
16
15
14
13
12
10
9
8
7
11
2
3
4
5
6
1
20
19
18
17
16
2
15
14
13
12
10
9
8
7
6
5
4
3
11
20
1

Description of touch panel
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Figure 2 –rear view
Nr.
Description
1
Serial interface for printer DPU-414
2
Serial interface for EDP connection
3
Mains connection with 2 fuses
4. Description of touch panel
The touch panel replaces a traditional keyboard and allows the device to
be operated intuitively.
Only apply light pressure and do not use sharp objects
for operation.
4.1 Used button symbols and function
When ready to measure:
Measurement is started.
When ready to measure:
Calls up device menu.
When ready to measure, during measurement
operation:
Calls up info menu.
1
2
3

Description of touch panel
User Manual Biosen C_line Clinic / GP+
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When ready to measure, during measurement
operation:
Calls up measured value memory.
When ready to measure, during measurement
operation:
Advises an urgent sample.
An urgent sample advised is indicated by a checkmark. By
pressing the button the urgent sample can be deregistered
again (the checkmark disappears).
In memory:
Scrolls to the first available position of the previous or
following tray.
In device menu, in info menu:
Moves the menu bar up and down, scrolls to next page.
In settings menu:
Changes figures or settings.
In memory:
Scrolls to the previous or next stored value.
In menu, in sub-menu:
Calls up the next, deeper menu level.
In settings menu:
Quits the settings menu incorporating any alterations.
In menu, in sub-menu:
Moves back to the next, higher menu level.
In settings menu:
Quits the settings menu without incorporating any
alterations.
During measurement operation:
Interrupts a running measurement or calibration. The
button press is indicated by a checkmark.
However the device first finishes the running operation.

Description of touch panel
User Manual Biosen C_line Clinic / GP+
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In measured value memory:
Calls up memory options.
In Stand By:
The device is in Stand By mode and can be switched on
by pressing the button (warm start).
During warm start:
The device is in warm start phase (switched on).
If the button is pressed again, the device reverts to the
Stand By mode. The button press is indicated by a
checkmark.
4.2 Navigation and operation
A position bar shows the currently selected menu item. If an arrow is
shown to the right of this menu item, this menu item contains further
sub-items.
In the settings menu values or settings can be changed using the arrow
buttons. If there are several changeable values or settings within one
(settings) menu item, the value to be changed must first be activated by
touching the button area. The frame surrounding becomes darker after
touching and indicates the activation in this way. Now this value can be
changed. Other values to be changed within the menu item 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 recommended to keep the arrow buttons pressed down
continuously.

Description of touch panel
User Manual Biosen C_line Clinic / GP+
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4.3 Device messages
Device messages are always shown in a separate window. There are
basically the following windows:
Advice window –with corresponding advice text
Advice windows cannot be confirmed. The instruction
displayed must be followed then the window disappears
automatically.
Example: "Please insert Sensor"
Question window –with corresponding question text
Question windows have to be confirmed with "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
error.
There are error texts which cannot be confirmed.
Example: "No system solution"
To remove this error 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"

Setting Up
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5. Setting Up
5.1 Setting up and initial start-up
Before you set up and connect the device, check that you have received
all components belonging to the product free of mechanical damage.
Device Biosen C_line
Sample tray (Clinic) respectively sample receptacle (GP+)
Bottles for system solution and waste
Power cable
Allow the device to reach room temperature!
When changing from a cold into a warm environment condensation can
form inside the device. Wait for about one hour before you connect the
device to the mains.
Select a suitable place for setting up the device and make sure to:
Ambient temperature: 15 - 35°C
humidity: 20 - 85%
avoid direct influence of damp
avoid direct sunlight
avoid strong electromagnetic fields
avoid direct influence from ionizing radiation
avoid rapid temperature variations (keep away from heaters,
open windows, ventilators, extraction or air conditioning
systems, etc.)
operate the device in dry rooms on a flat, waterproof surface
free space on the ground required across the whole of the
installation area for ventilation
The device is designed for a mains voltage of
100-240 Volt and a frequency of 50 or 60 Hz. Set the mains frequency in
the device menu (Section 9.8, page 37) to the correct value of your
region. For further enquiries contact your technical consultant or dealer.

Setting Up
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5.2 Preparations for device operation
5.2.1 Consumables
The following consumables are needed:
Pour system solution into the bottle (see Section 3 (19), page 7)
and place in the appropriate opening.
Place the empty waste bottle (see Section 3 (18), page 7) in the
appropriate opening.
Chip sensors for glucose and / or lactate measurement
Pre-filled micro test tubes for sampling
Micro test tubes with calibration solution (standard)
5.2.2 Pump tube
The device is delivered with a pump tube which is hung externally, in
order to avoid the tube becoming stuck when at rest. For initial start-up
the pump tube must be hung on.
State on delivery
Open pump flap (raise up from
right to left).
Figure 3 –Pump tube hung externally
The pump tube must be hung on
and centered on the pump rollers.
A rounded pair of tweezers is
recommended for this. Do not use
sharp objects.
Then close the pump flap from left
to right.
Figure 4 –hanging on pump tube

Setting Up
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5.2.3 Chipsensor
The chip sensors are the core of the measuring system. They convert
the sample concentration into an analysable, electrical signal. For further
information, see Section 15, page 52.
Only type II chip sensors from EKF-diagnostic GmbH may be used.
EKF-diagnostic GmbH offers chips sensors for glucose and lactate
determination as well as dummy sensors (see Section 16, page 54).
The device has at least one or optionally two measuring channels. With
two measuring channels, glucose and lactate can be measured from
one sample at the same time. The device recognizes the chip sensors
(glucose, lactate, dummy sensors) automatically. No manual settings
are required
It does not matter which sensor is placed in which measuring channel.
The same parameter can be measured on both channels. It is
recommended to equip measuring channel 1 with glucose and
measuring channel 2 with lactate. If a device with two measuring
channels is operated with only one sensor, there needs to be a dummy
sensor (accessory) in measuring channel 2. In this case it is
recommended to place the active sensor in measuring channel 1 (higher
measuring speed).
5.2.3.1 Sensor insert
Connect the device to the mains supply. The display will read "No
sensor found".
Open the sensor latch by pressing
it down on the open side.
Figure 5 - Opening the sensor latch

Setting Up
User Manual Biosen C_line Clinic / GP+
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Push the latch further up from
below to open the sensor flap
completely.
Figure 6 - Opening the sensor flap
Opened sensor block
Figure 7 - Sensor flap open
Do not touch the electrical contacts and do not apply
moisture to the electrical contacts. Carefully dab away moisture on the
flow cell and sensor bracket using a lint-free cloth.
Hold the sensor only as illustrated
in the figure. Do not touch the
area with the beveled corner!
Figure 8 - Sensor
Insert the sensor into the sensor
bracket and press down until it
stops. The arrow on the reverse
side must be visible and pointing
in the direction of insertion.
Figure 9 - Inserting the sensor
Sensor
bracket
Sensor flap
electr.
contacts
Flow cell
Do not
touch!

Setting Up
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If the sensor is inserted incorrectly and the sensor flap
is forced down, the sensor will be damaged.
Close the sensor flap and press
the latch down on the closed side
until it audibly engages.
Figure 10 - Closing the sensor flap
Repeat this procedure for the second measuring channel if applicable.
Once the measuring channel is equipped correctly, the "Sensor
Replacement" window opens where the inserted sensors has to be
identified as "New".
After the sensor is inserted, the device needs some time for sensor
conditioning. This time is shown on the display and counts down. The
device is not ready for measurement during this period.
5.2.3.2 Sensor replacement
Chips sensors are subject to deterioration and must be replaced at
regular intervals. The sensor should be replaced at the latest after 60
days for glucose and after 50 days for lactate. Dummy sensors can be
used as long as there are no leaks in the flow system
It is possible to check the chip sensors with a sensor test solution or a
linearity solution (see section 16, page 54).
If adjustment of whole blood-/plasma glucose is
activated (see Info Menu "Info-4 Options") the sample type
must be set as Serum for measurement of sensor test solution or
linearity solution.
Only Replace sensors when then device is connected to the mains
supply.
Risk of infection, wear suitable gloves!