Summary of Contents for MAYOLY SPINDLER Kibion Dynamic Base
- Page 1 Instruction for Use ® Kibion Dynamic ® ® Kibion Dynamic Base Kibion Dynamic Pro Article. No 8031 Article. No 8032 Ref. Br 328-10, March 2017, Kibion GmbH Page 1(23)
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Page 2: Table Of Contents
TABLE OF CONTENTS PRODUCT................................... 3 SYMBOLS ................................3 PRODUCT DESCRIPTION ........................... 4 ..........................4 NTENDED USE AND INTENDED USER ............................... 4 LASSIFICATION ................................. 4 OMPONENTS ................................4 SSECCORIES PRINCIPLES OF OPERATION ..........................5 KIBION DYNAMIC SOFTWARE ........................... 5 USER INFORMATION ............................5 ............................ -
Page 3: Product
If the equipment is used in a manner not specified in this Instruction for use, the protection provided by the equipement may be impaired. This Instruction for Use is valid for Kibion Dynamic Base and Pro running software version 1.5.0.4. -
Page 4: Product Description
Kibion Dynamic devices are intended to be used by trained staff, mostly in hospital and or laboratory environment. 2.2 Classification Kibion Dynamic Base and Pro are classified as general/other In Vitro Diagnostic medical devices and CE-marked according to the European In Vitro Diagnostic medical device directive 98/79 EC. -
Page 5: Principles Of Operation
Do not use disinfections containing ammonia or acetone. The filtermaterial in the Kibion Dynamic Base filter contain sodalime which should be handled as a corrosive chemical. Please, contact you local distributor or Kibion in case of any filter damage or leakage of LiOH. -
Page 6: General Use And Disinfection
(temp15-25 °C, humidity < 70% rH). 6.1 Installation of Kibion Dynamic Base a) Kibion Dynamic Base should be placed on a solid and stable table or rack on an even surface to avoid any vibrations or disturbance. The devices must be placed so that there is at least 20 cm space around the device to assure enough air circulation and to avoid overheating. -
Page 7: Warming Up - Target Temperature
Connect to the middle tube connector on the Kibion Dynamic Base. h) Connect the delivered network cable to the Ethernet port on the Kibion Dynamic Pro and the Ethernet port next to the center of the Kibion Dynamic Base. 7. WARMING UP – TARGET TEMPERATURE Turn on the device and keep it ON for at least 12 hours for warming up and reach constant target temperature. -
Page 8: Operation Overview
8.2 Operation overview Kibion Dynamic is easily operated from a touch screen. User inputs are added using a key-board, screens can be printed and shown content exported to an USB-stick directly by touching buttons with symbols on the screen. Key-board Open the key-board by pressing the key-board button. - Page 9 Fig. 1 Log-in view Fig. 2 The main menu view from where all main functions are accessed. Ref. Br 328-10, March 2017, Kibion GmbH Page 9(23)
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Page 10: Measurement
MEASUREMENT 9.1 Calibration The device must be regularly calibrated for correct measurement function. A valid calibration must exist before a test can be started. If the calibration has not been performed accordingly the measurement will be rejected and the device shows an error message for missibg calibration. - Page 11 A progress bar shows the calibration progress (Fig. 5) “Calibration successful” is shown when the calibration is completed (Fig. 6). Fig. 4. The view for daily calibration guides you how to take a sample and connect the BreathBag. Fig. 5. The calibration progress is shown. Ref.
- Page 12 Fig. 6. Calibration susseccful is shown when the calibration is completed. Monthly Calibration 1. Press the Monthly calibration button. 2. The view shows a guide for how to perform a monthly calibration (Fig 7). 3. Hold your breath for at least 30 seconds. 4.
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Page 13: Measuring Samples
Fig. 7. The view for monthly calibration guides you how to take a sample and where to connect the Breathbag. 9.3 Measuring samples Select and press the “Analysis”button in the main menu. The analysis set-up view appears (Fig 8). 1. Type patient name or identity using the key-board on the screen or scan the identity using a bar code reader connected via USB to the Base-unit. - Page 14 Fig. 8. The view for analysis set-up. Fig. 9. Patient set-up view. Ref. Br 328-10, March 2017, Kibion GmbH Page 14(23)
- Page 15 A view appears showing which sample ports the breath bags or glass vials should be connected to. Depending on which unit is selected, Base or Extension unit (Pro), the connection looks different (Fig 10 and Fig 11). NOTE: Glass vials with a fixed cap can only be used on Kibion Dynamic equipped and with needles.
- Page 16 Fig. 11. View showing the sample connection to the Extension unit. is used for adding more tests. A view showing the progress of the maesurment appears (Fig. 12). Fig. 12. The view of measurement progress. The measurement can be stopped anytime by pressing the “Cancel” button. Please choose in the pop-up window by clicking “Retry”...
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Page 17: Results
9.4 Results 1. Press the “Result” button in the main menu to view the results from the analysis (Fig 1). 2. The results can be filtered by selected by pressing Day”, “Week” or “All”. 3. Search for an ID or Test-Type can be done by the “search” symbol in the upper right corner. -
Page 18: Sample Collection For Measurement
Fig. 15. Graphic view of a selected result. 8. Press on a row in the result list to view detailed results from the selected test. 9. The result from a selected test can be shown either as listed DOB value by pressing Data or as a graph by pressing Graph. -
Page 19: Glass Vial Sample Collection
10.2 Glass vial sample collection Perform the breath sampling according to the instruction provided with the kit. 11. TROUBLESHOOTING In case of any malfunction of Kibion Dynamic devices, please contact your local distributor for support. In case of a power failure please, make sure that Kibion Dynamic has been warmed up for at least 12 hours before use. -
Page 20: Service And Maintenance
Kibion service technician or by certified service technician authorized by Kibion. Life time of the Kibion Dynamic devices are 10 years. 13. TECHNICAL INFORMATION 13.1 Analytic data Kibion Dynamic Base Kibion Dynamic Pro <0,5‰ <0,5‰ Reproducibility... -
Page 21: Technical Data
13.2 Technical data Kibion Dynamic Base Kibion Dynamic Pro Width * Height * Depth 280 * 320 * 380 (mm) 500 * 320 * 380 (mm) Weight 13 (kg) 11,5 (kg) Electrical connections 100-120/200-240 (VAC) 100-120/200-240 (VAC) 50-60 (Hz) 50-60 (Hz) -
Page 22: Addendum
ADDENDUM 15.1 „Delta“ and “DOB” – value; definition and comments The „Delta“-value of a breath sample R s describes the C-ratio at the carbon dioxide of the particular breath sample in relation to the C-isotope ratio of the world wide accepted carbon isotope standard X „PD-Belemnite“ (PDB) - carbonate material with its C-ratio stated as R = 0,0112372 . -
Page 23: Customer Support And Contact Information
16 CUSTOMER SUPPORT AND CONTACT INFORMATION Please contact your local distributor or Kibion for any support. Local Distributor contact details (if applicable) Kibion GmbH Haferwende 31 28357 Bremen Germany www.kibion.com E-Mail: support.kibion@mayoly.com Phone +49 (0) 421 27 86 5-0 Fax+49 (0) 421 27 86 5-20 a company of Ref.
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