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EKF Diagnostics Biosen C-Line Clinic User Manual

Glucose/lactate measuring system
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Biosen C-Line | Clinic / GP+
Glucose/Lactate Measuring System
User Manual

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Summary of Contents for EKF Diagnostics Biosen C-Line Clinic

  • Page 1 Biosen C-Line | Clinic / GP+ Glucose/Lactate Measuring System User Manual...
  • Page 3 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. Manufacturer: EKF-diagnostic GmbH Ebendorfer Chaussee 3, 39179 Barleben Germany Phone: +49 39203 511 0 Fax: +49 39203 511 171 Manual revision: 3.0 Released: 05/2024...

  • Page 4: Table Of Contents

    Contents IMPORTANT INFORMATION / SAFETY NOTES SYMBOLS SAFETY NOTES ABBREVIATIONS INTENDED USE DESCRIPTION OF DEVICE COMPONENTS DESCRIPTION OF GRAPHICAL USER INTERFACE SETTING UP PLACE OF INSTALLATION PREPARATIONS FOR DEVICE OPERATION 4.2.1 Bottles 4.2.2 Pump tube 4.2.3 Chip Sensor 4.2.4 Mains BARCODE (ONLY C-LINE CLINIC) 4.3.1 Barcode format...
  • Page 5 MEASUREMENT SAMPLING 5.1.1 Taking a sample of capillary blood 5.1.2 Other sample materials SAMPLE MEASUREMENT URGENT SAMPLES (STAT) MEMORY SCREEN MAINTENANCE SURFACE CLEANING AND DISINFECTION CLEANING / DISINFECTION OF THE FLOW SYSTEM SENSOR REPLACEMENT EXCHANGE PUMP TUBE EXCHANGER AND SAMPLE CANNULA SWITCHING THE DEVICE OFF BRIEF SEPARATION FROM THE MAINS (<72H) LONGER SEPARATION FROM THE MAINS (>72H)

  • Page 6: Important Information / Safety Notes

    0. IMPORTANT INFORMATION / SAFETY NOTES 0.1 Symbol The following symbol is used in this user manual: Caution This Symbol indicates that caution is necessary when operating the device, or to indicate that the current situation needs operator aware- ness or operator action in order to avoid undesirable consequences. 0.2 Safety Notes It is essential that you read the following notes to avoid risks to persons and damage to the device and other equipment.

  • Page 7: Abbreviations

    Only use the Biosen C-Line for the purpose described in section 1. Observe the specifications for the use, storage and transport of products. Only use equipment and consumables, which are expressly approved by EKF-diagnostic GmbH for use with the Biosen C-Line. Moving Parts The device has parts that can move unexpectedly during normal operation.

  • Page 8: Intended Use

    1. INTENDED USE The Biosen C-Line is an automated analyzer intended to be used for quantitative in-vitro diagnostic determination of chemistry analytes using the Biosen Sensors and Consumables. It is used for near-patient testing by healthcare professionals and laboratory testing by laboratory professionals.

  • Page 9: Description Of Device Components

    2. DESCRIPTION OF DEVICE COMPONENTS 15 14 15 14 3 4 5 3 4 5 Figure 1 – Front view C-Line Clinic C-Line GP+ Display with touch panel Display with touch panel Tray for 20 samples Tray for 5 samples 3, 4 Positions for standard 1 and 2 (STD1, STD2) Positions for standard 1 and 2 (STD1, STD2)
  • Page 10 Figure 2 – Rear view Description Mains connection with 2 fuses Serial interface for printer DPU-S445 Serial interface for EDP connection Ethernet...

  • Page 11: Description Of Graphical User Interface

    3. DESCRIPTION OF GRAPHICAL USER INTERFACE The touch panel is the main interface for the user. The home screen is displayed in Figure 3. You can see the status of the device (1) and use the main functions to perform measurement (2) and access the memory (3) directly from this screen. Description Status of the device + advice text Perform measurement...

  • Page 12: Menu Overview

    All functions are available in the main menu. If you look for a specific function, you can use the menu overview to navigate fast to the desired function. Menu Overview Main Menu Ready Counter Preset Device Settings Calibration required Limits Maintenance Memory Perform...
  • Page 13 Device Settings (Local) Language Power Frequency Date Format Time Format Maintenance Set Date Set Time Cleaning Emptying Device Settings (Measurement 1 of 2) Calibration Mode Sensor Selection Unit Glu Unit Lac Device Settings (Measurement 2 of 2) Sample Type Ref. Type Glu Hold last Result Device Settings (Device)

  • Page 14: Setting Up

    4. SETTING 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 •...

  • Page 15: Preparations For Device Operation

    4.2 Preparations for device operation 4.2.1 Bottles • Pour system solution into the bottle (Figure 1) and place in the appropriate opening. • Place the empty waste bottle (Figure 1) in the appropriate opening. 4.2.2 Pump tube The device is delivered with a pump tube disconnected from the pump rollers, this is in order to avoid the tube becoming stuck when at rest.

  • Page 16: Chip Sensor

    4.2.3 Chip Sensor The chip sensors are the core of the measuring system. They convert the sample concentration into an analyzable, electrical signal. 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 10.1).
  • Page 17 Push the latch further up from below to open the sensor holder completely. Figure 12 - Opening the sensor holder Sensor bracket Sensor flap Opened sensor block. Flow cell Electr. contacts Figure 13 - Sensor holder open Do not touch the electrical contacts and do not apply moisture to the electrical contacts.
  • Page 18 Hold the sensor only as illustrated in the figure. Do not touch the area with the beveled corner! Do not touch! Figure 14 - 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.

  • Page 19: Mains

    Close the sensor holder and press the latch down on the closed side until it audibly (click) engages. Figure 16 - Closing the sensor holder 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”.

  • Page 20: Barcode (Only C-Line Clinic)

    4.3 Barcode (only C-Line Clinic) If the barcode function is activated (default setting), the barcode scanner reads barcode labels of samples which are placed in the sample tray. In standard, control and STAT positions the barcode cannot be read. The internal barcode scanner can be activated or deactivated in the main menu/ device settings/barcode/Reader menu.

  • Page 21: Positioning Of The Barcode Label

    4.3.3 Positioning of the barcode label Hinge of Lid The label must be stuck centered to the Name: Name: Label must be flush hinge axis, vertically and without folds. with rim of micro test tube The label must not come off, particularly in the upper area, hence press it on firmly.

  • Page 22: Adjustment Whole Blood Glucose/Plasma Glucose (Optional)

    “Time account” The device is ready to measure for 60 minutes after a calibration. At measurement start the samples are measured immediately. In the home screen the following is displayed: “Ready Calibration valid xx min”. Once the 60 min have elapsed calibration does not take place automatically.

  • Page 23: Quality Control

    4.6 Quality control EKF-diagnostic GmbH recommends regular performance of quality control measurements. EKF-diagnostic GmbH offers different control materials (see section 10.1) to facilitate compliance with local, state and/or federal regulations or accreditation requirements. For handling the control material refer to the respective operating instructions.

  • Page 24: Prepaid Mode (Optional)

    4.7 Prepaid Mode (optional) In the prepaid mode, measurements are only possible when the device is in credit. Credit is paid to the device using a Prepaid Card. Prepaid Cards always belong to a particular device by means of the serial number and are available with different amounts of credit.

  • Page 25: Connectivity

    4.9 Connectivity A connection can be established via USB, serial or ethernet connection. Use the plugs at the rear of the device (see Figure 2). Under menu item main menu/device settings/connectivity all parameters for data exchange can be set. This menu item contains all relevant parameters for connecting the device with the hospital’s laboratory or POCT data management software and also EKF Link or EKF Link Lite.

  • Page 26: Measurement

    5. MEASUREMENT 5.1 Sampling The sample is taken up with an end-to-end capillary and hemolyzed in a micro test tube, pre-filled with a hemolyzing solution. This involves thinning the sample by 1:51. Capillary blood, venous blood, plasma or serum can be used as sample material. Refer to the instructions for use of the used chip sensor.
  • Page 27 Risk of infection, wear protective gloves! Clean and disinfect the puncture site and allow it to dry. Residues of sweat and disinfecting solution can falsify the results. Figure 19 - Disinfection Press lightly on the fingertip and puncture from the side using a suitable lancing device.
  • Page 28 a. Correctly filled capillary. b. Capillary is not completely filled and contains air bubbles. This capillary must be disposed of. c. Capillary with excess blood at the end. This capillary must be carefully wiped off. Figure 22 - Filled capillaries Remove excess blood at the end of the capillary.

  • Page 29: Other Sample Materials

    The sample prepared in this way can be measured immediately. It is recommended to measure as soon as possible. The glucose and lactate concentration in hemolyzed sample, in closed and not punctured micro test tubes, is stable at room temperature for a storage period of 5 days.

  • Page 30: Sample Measurement

    5.2 Sample measurement Place the samples to be measured in the sample positions. Pressing the Perform measurement button (2) starts the measurement process. Figure 26 – Home screen view The device recognizes and runs inserted micro test tubes automatically. Depending on the state of calibration, either the calibration of the device takes place first and then the sample measurement, or the sample measurement takes place directly.
  • Page 31 The screen shown in Figure 27 is shown at the end of the measurement process. The information that is shown is described below. Figure 27 - Measurement Screen No.. Item Description Shows the measured parameter, the current measurement value and Measuring Channel 1 the unit in channel 1.

  • Page 32: Urgent Samples (Stat)

    5.3 Urgent samples (STAT) To measure an urgent sample, put the sample in the STAT position (see Nr. 7 in Figure 1). The inserted urgent sample is automatically recognized by the device and processed as quickly as possible. 5.4 Memory screen The following figure shows the stored test results.
  • Page 33 Page Indicator Indicates can swipe to the side to switch from test results to QC test results. Result context menu. You can send and print the results here. “Sends values to EDP” Last tray Sends the last measured series Selected tray Sends the series, currently selected in the memory Selected value Sends the value, currently selected in the memory...

  • Page 34: Maintenance

    6. MAINTENANCE The device should be subject to regular maintenance. Table 1 gives an overview of the required maintenance frequency. Table 1 - Overview of required maintenance actions Action Description Surface cleaning Daily Surface disinfection If contaminated Disinfection of the flow system Before change of any maintenance part Exchange of Lactate sensor See IFU of sensor...

  • Page 35: Cleaning / Disinfection Of The Flow System

    6.2 Cleaning / Disinfection of the flow system The chip sensor is destroyed by the used solutions. However, a chip sensor has to be in the measuring channel. Only carry out this procedure if the sensor needs to be changed or an old sensor or dummy sensor is available.

  • Page 36: Exchange Pump Tube

    Insert the new sensor as illustrated in Figure 14 to 16. Once the measuring channel is equipped correctly, the “Sensor Replacement” window opens. Here, you must enter whether the sensor you just inserted is “New” or “Used”. It is very important to enter correctly as the device runs different conditioning programs.
  • Page 37 Push the tube into the constriction between the metal rod and the housing. Make sure that the red and black markings remain on the side of the tube connections. Figure 31 – push tube into the constriction The pump tube must be looped over and centered on the pump rollers.

  • Page 38: Exchanger And Sample Cannula

    6.5 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. Empty the whole flow system using the menu item main menu/maintenance/emptying and follow the instructions on the screen. Screws Pull the tube away from the sample cannula and loosen the...

  • Page 39: Switching The Device Off

    Pull the exchanger out of the tube and put on a new exchanger. Push the tube as far as it will go. Figure 36 - change exchanger Construction is in the opposite order. Turn the exchanger-tube connection in the direction of the pivot arm until it noticeably engages. Then insert the sample cannula carefully from the top.

  • Page 40: Brief Separation From The Mains (<72H)

    6.7 Brief separation from the mains (<72h) For shipment or transport, the device can be separated from the mains for a maximum period of 72 hours. The bottles for system solution and waste must be emptied. All micro test tubes must be removed. 6.8 Longer separation from the mains (>72h) If the device is not used for some days, it should be put into stand-by mode.

  • Page 41: Disposal

    6.9 Disposal Comply with the applicable local disposal regulations. The user is responsible to ensure proper disposal of the individual components. Dispose of containers of potentially infectious solutions (micro test tubes, hemolysate, control blood, etc.) in accordance with the current regulations applicable to your establishment.

  • Page 42: Troubleshooting

    7. TROUBLESHOOTING Before you call the hotline or send the device in for repair, please try to identify or solve the problem with the help of this section. Error text Explanation and rectification Please follow these steps, until the problem is solved 1.
  • Page 43 Error text Explanation and rectification Device was removed from the mains for some hours or days → Chip sensor stabilizes. Wait until device automatically goes into readiness to measure. Chip sensor has been changed → Chip sensor stabilizes. Wait until device automatically goes into readiness to measure.
  • Page 44 Error text Explanation and rectification Incorrect or unsuitable multi standard → Use a new original multi standard micro test tube, if possible from new packaging Leaky flow system. Exchanger, sample cannula or pump tube worn out or defect → Control flow system, change exchanger, sample Calibration value sensor1(2) instable cannula or pump tube if required System solution unsuitable...
  • Page 45 Error text Explanation and rectification Several attempts with manipulated Prepaid-Cards Device is locked → Service required Prepaid Card was removed without advice Smart card access interrupted → Insert Prepaid Card again Devaluated or unknown Prepaid Card Invalid smart card → Remove Prepaid Card Serial number of Prepaid Card does not match serial number of the device.

  • Page 46: Technical Data

    8. TECHNICAL DATA Measurement principle Enzymatic - amperometric Glucose: 0,5-50 mmol/l (9-900 mg/dl) Measurement range Lactate: 0,5-40 mmol/l (5-360 mg/dl) Sample material Blood, plasma or serum Sample volume 20 µl / 10 µl Expected lifetime 5 years Ambient conditions during operation +15 °C to +35 °C Temperature Relative humidity...

  • Page 47: Theoretical Principles

    9. THEORETICAL PRINCIPLES 9.1 Reference ranges For specification of reference ranges there must be differentiated between whole blood glucose and serum/plasma glucose. Based on the different content of water depending on the hematocrit (Hct: solid parts) value, the measured glucose value in hemolysed whole blood is always lower than in plasma and serum, which show the same glucose value.

  • Page 48: Calibration

    9.3 Calibration The calibration of the device takes place shortly before measurement. A glucose/lactate solution of known concentration (12 mmol/l, thinned 1:51) is measured on the device. The measured current signal and the corresponding glucose/lactate concentration are used as base for calculation of unknown concentrations. The value of the calibrator for glucose is traceable to NIST (National Institute of Standards &...

  • Page 49: Appendix

    10. APPENDIX 10.1 Replacement parts and consumer materials Order No. Designation Unit Sensors 5206-3011 Chip sensor glucose Type II 1 piece Chip sensor lactate Type II 5206-3029 1 piece 5206-3115 Dummy to insert into the sensor-block (type II) 1 piece Consumables Multi Standard Solution 12 mmol/l 5211-3015...
  • Page 50 Order No. Designation Unit Equipment 0620-0106-0070 Printer cable 1 Piece Thermal Printer DPU-S445 0620-0105-0334 1 Set Thermal printer with mains adaptor and printer Thermal paper 0203-0100-204 1 Set Suitable for DPU-S445, Set of 5 rolls 5211-8019 Transport case for Biosen C-Line 1 piece EDP serial Cable, 3 m 0720-0100-0283...

  • Page 51: Contact

    10.2 Contact If you have any questions beyond this manual, we will be pleased to help you. Here is all important contact information for you at a glance: Postal address: EKF-diagnostic GmbH Ebendorfer Chaussee 3, 39179 Barleben Germany Service hotline: +49 39203 511 414 email: support@ekf-diagnostic.de...

  • Page 52: Symbols

    10.3 Symbols Manufacturer Storage temperature Consult instructions for use Do not reuse Use-by-date Caution Dispose of electric and Biological Risks electronic devices separatelys Contains sufficient for <n> tests Reference number Lot number In vitro diagnostic medical device Serial number Control...
  • Page 53 Date of manufacture Unique Device Identifier Fuse Device for near-patient testing Alternating current Keep dry CE mark...
  • Page 56 EKF-diagnostic GmbH Tel: +49 39203 511 414 Email: support@ekf-diagnostic.de Ebendorfer Chaussee 3, ekfdiagnostics.com 39179 Barleben 5214-9014-0200 | Rev.3.0 Germany...

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Biosen c-line gp+
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