MAYOLY SPINDLER Kibion Dynamic Base User manual

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Instruction for Use
Kibion®Dynamic
Kibion®Dynamic Base Kibion®Dynamic Pro
Article. No 8031 Article. No 8032

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TABLE OF CONTENTS
PRODUCT................................................................................................................................................................... 3
1. SYMBOLS.......................................................................................................................................................... 3
2. PRODUCT DESCRIPTION ................................................................................................................................... 4
2.1 INTENDED USE AND INTENDED USER.............................................................................................................................4
2.2 CLASSIFICATION .......................................................................................................................................................4
2.3 COMPONENTS .........................................................................................................................................................4
2.4 ASSECCORIES...........................................................................................................................................................4
3. PRINCIPLES OF OPERATION .............................................................................................................................. 5
4. KIBION DYNAMIC SOFTWARE........................................................................................................................... 5
5. USER INFORMATION ........................................................................................................................................ 5
5.1 SAFETY AND PRECAUTIONS .........................................................................................................................................5
5.2 GENERAL USE AND DISINFECTION................................................................................................................................. 6
5.3 MOVING AND TRANSPORT ......................................................................................................................................... 6
6. INSTALLATION .................................................................................................................................................. 6
6.1 INSTALLATION OF KIBION DYNAMIC BASE......................................................................................................................6
6.2 INSTALLATION OF KIBION DYNAMIC PRO.......................................................................................................................6
7. WARMING UP –TARGET TEMPERATURE .......................................................................................................... 7
8. INITIAL OPERATION .......................................................................................................................................... 7
8.1 INTERFACES.............................................................................................................................................................7
8.2 OPERATION OVERVIEW..............................................................................................................................................8
8.3 LOG-IN..................................................................................................................................................................8
9. MEASUREMENT.............................................................................................................................................. 10
9.1 CALIBRATION.........................................................................................................................................................10
9.2 PERFORM CALIBRATION ...........................................................................................................................................10
9.3 MEASURING SAMPLES .............................................................................................................................................13
9.4 RESULTS ...............................................................................................................................................................17
10. SAMPLE COLLECTION FOR MEASUREMENT .................................................................................................... 18
10.1 BREATHBAG SAMPLE COLLECTION .........................................................................................................................18
10.2 GLASS VIAL SAMPLE COLLECTION ..........................................................................................................................19
11. TROUBLESHOOTING ....................................................................................................................................... 19
11.1 ERROR MESSAGES..............................................................................................................................................19
12. SERVICE AND MAINTENANCE ......................................................................................................................... 20
13. TECHNICAL INFORMATION ............................................................................................................................. 20
13.1 ANALYTIC DATA.................................................................................................................................................20
13.2 TECHNICAL DATA ...............................................................................................................................................21
13.3 ENVIRONMENTAL WORKING AND STORAGE CONDITIONS............................................................................................ 21
14 DISPOSAL ....................................................................................................................................................... 21
15 ADDENDUM ................................................................................................................................................... 22
15.1 „DELTA“AND “DOB” –VALUE;DEFINITION AND COMMENTS ....................................................................................22
15.2 EVALUATION AND EXPLANATION OF DATA............................................................................................................... 22
16 CUSTOMER SUPPORT AND CONTACT INFORMATION ..................................................................................... 23

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PLEASE NOTE
To preserve the protection afforded by the equipment, please read this Instruction for
use prior to any handling of the equipement.
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.
PRODUCT
Kibion®Dynamic Base
Article No. 8031
Kibion®Dynamic Pro
Article No. 8032
MANUFACTURER
Kibion GmbH Contact information
Haferwende 31 E-mail [email protected]
28357 Bremen Phone [phone]
Germany www.kibion.com
1. SYMBOLS
Conformite Europeenne
Read the instructions for use
Manufacturer
Warning
Disposed as electronical waste

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2. PRODUCT DESCRIPTION
2.1 Intended use and intended user
Kibion Dynamic is an InfraRed ISotop Analyser for 13 CO2in breath test samples.
(Infrarot Isotopen Analysator für 13C Atemgasanalyse).
Kibion Dynamic devices is used for measurement and comparison of the isotope
ratio 13 CO2/12 CO2in breath test samples for In vitro diagnostic purposes.
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.
2.3 Components
Kibion Dynamic Base
•Power cable
•Instruction for use
Kibion Dymanic Pro
•Power cable
•Tube
•Ethernet cable
2.4 Asseccories
Article
Article No
DoubleBreathbag, 2x 0,1L volume, 200 mm x 170 mm. with
connecting hose, for single use, disposal as packaging garbage.
8005
Single Breathbag, 1.3 L volume, 300 mm x 150 mm with
connecting hose, for single use, disposal as packaging garbage.
8004
MouthPiece
with one-way valve as hygiene barrier for single use (material
PE, hygienically packed), disposal as a packaging garbage.
8007
Glas vials for breath samples
with fixed cap (up to 17 mm in diameter with at least 10 mL
volume). Supplied in the Diabact® UBT kit
Not supplied
separately
Fuses, T2AH250VAC, IEEC/EN60127-2/5, 5*20mm
Not supplied by
Kibion

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3. PRINCIPLES OF OPERATION
Kibion Dynamic is using non-dispersive IR-spectroscopy (NDIR) a broad-band light
source and acoustic-optical detectors which are sensitive only to those wavelengths
at which the gases to be measured are IR-absorbing. With two such detectors,
individually sensitive to the absorption spectra for 12CO2and 13CO2, the
concentrations of these two gas components to be related to each other for 13C/12C-
isotope ratio determination are measured. The IR-absorption spectra of the
asymmetrical stretch oscillation modes of both the 13CO2–and 12CO2-molecules are
separated almost completely.
The concentrations of 13CO2in breath gas are in the range of 50 to 500 ppm, where
12CO2accordingly is at concentrations of 0,5 to 4,5 Vol.%. Within that device, every
measurement of the gas components IR-absorption is related to a full energy
measurement of the IR-light source, available by a reference gas cell filled with a
non-IR-absorbing gas.
4. KIBION DYNAMIC SOFTWARE
Kibion Dynamic Software is based on WINDOWS operating systems and provides
routines for calibrations, for sample definitions and measurement control.
The database provides standardized procedures for breath and records for patient
data and test results.
5. USER INFORMATION
5.1 Safety and precautions
Kibion Dynamic must only be used with Kibion Breathbag or glass vial.
Protective gloves should be used while handling human samples.
Do not disassemble or alter any part of the unit.
Do not place anything on the top of the Kibion Dynamic devices.
Installation must be conducted by Kibion or by trained staff from the local distributor.
Kibion Dynamic devices must be placed and installed on a stable surface without
any vibrations.
Kibion Dynamic devices must be handled with care and do not expose to any shocks
or outer damage.
Service and repair must only be conducted by Kibion or by trained staff from the
local distributor.
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.
The device should not be used in the presence of explosive gases, flammable,
anesthetic gases mixed with air, oxygen or nitrous oxide.

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Do not use the device in proximity to sources of strong electromagnetic radiation as
these may interfere with the proper operation.
5.2 General use and disinfection
The device is intended for the exclusive use with breath test samples.
The outer casing of the device can be cleaned using a dry cloth.
Disinfection of the outer casing and sample ports can be done using a cloth wetted
in 70 % ethanol. Do NOT spray ethanol on the device.
After mains failure, the device can be disturbed in function. To overcome this, restart
the device and wait 12 hours till temperature stability is assured.
5.3 Moving and transport
Turn off and unplug the device.
Any moving of the device must be done in horizontal position.
Handle the device with care and avoid any shocks.
If the device must be transported contact you local distributor for information.
Re-installation of moved or transported device should be performed according to
installation instruction (see chapter 5).
6. INSTALLATION
NOTE:
Kibion Dynamic devices should be installed for stationary use.
Ensure the power plug is accessible for disconnection in case of emergency.
Kibion Dynamic devices should be operated at laboratory indoor conditions
(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.
b) Connect the device to a grounded power supply using the supplied power cable.
6.2 Installation of Kibion Dynamic Pro
c) Kibion Dynamic Pro should be placed on a solid and stable table or rack on an
even surface to avoid any vibrations or disturbance.
d) Place the Kibion Dynamic Pro within 50 cm distance to the Kibion Dynamic Base.

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e) Connect the device to a grounded power using the supplied power cable.
f) Connect the gas tube to the connector on the backside of the Kibion Dynamic Pro.
g) 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.
NOTE:
Target temperature must be reached to ensure measurement specifications. To
preserve the reached target temperature the Kibion Dynamic devices should be kept
ON when it is in routine use.
8. INITIAL OPERATION
8.1 Interfaces
Kibion Dynamic Base has two USB ports for multiple usages. HID-Devices can be
connected if they are plug & play compatible to Windows 7. Printers can be
connected directly to the device.
Kibion Dynamic Base has two RJ-45 connectors for connection to local LIS-systems.
Please contact your local distributor for assistance.
Kibion Dynamic Pro has one Ethernet connector for communication with the Base
unit and one connector for gas connection to the Base unit.

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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.
Print.
Print the viewed screens by pressing the printer button.
Export
Export data to a conncted USB-stick by pressing the export button.
Restart
Restart the device bt pressing the restart button.
Switch
Switch OFF by pressing the swich button.
8.3 Log-In
Switch ON
A log-in view appear.
Default user name is “Max Mustermann”
Enter the password “1234567”.
Press the arrow symbol for next step
The main menu view appears from where all main functions are accessed.

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Fig. 1 Log-in view
Fig. 2 The main menu view from where all main functions are accessed.

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9. 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.
There are two types of required calibrations, daily and monthly calibration. The daily
calibration must be performed every day prior the first test of the day. The monthly
calibration should be performed every 30 days.
9.2 Perform calibration
Press the Calibration button in the main menu.
The calibration view appears.
Fig. 3 Calibration view from where the calibration is operated.
Daily calibration
1. Press the Daily calibration button.
2. The view shows a guide for how to perform daily calibration (Fig. 4).
3. Exhale into a Breathbag and fill it with “normal” breath air (single or double bags
works for this purpose).
4. Connect the Breathbag to Sample Port 1 (on the left side).
5. Press the arrow to start the daily calibration.

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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.

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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. Exhale into a 1L single Breathbag and fill the bag with “normal” breath air.
5. Connect the Breathbag to Sample Port 1 (on the left side).
6. Press the arrow to start the monthly calibration.
The calibration takes about 35 minutes and a progress bar shows the calibration
progress (similar as in Fig. 5)
“Calibration successful” is shown when the calibration is completed (Fig.6)

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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.
2. Enter the patient ID (optionally).
3. Select the defined test types from a drop-down menu.
4. Select whether to run the analysis on the Base unit or the Extension Unit (Pro).
5. Press the arrow to the right to continue.
The patient set-up view appears (Fig 9).
6. Enter specific patient data for the internal database (if applicable, not
mandatory).
NOTE: All fields are optional.
7. Press the right arrow to continue.

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Fig. 8. The view for analysis set-up.
Fig. 9. Patient set-up view.

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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. For connection, the glass vial should be pushed upon the needle until the
end of the duct.
8. Connect the samples according to the instruction in the view.
9. Press the arrow to the right to start the measurement.
Additional tests can be added during the ongoing measurement by setting-up tests
for analysis as described above.
If you are using the Extension unit (Pro) press the to open the analysis main
menu for adding more tests.
Fig. 10. View showing the sample connection to the Base unit.

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Fig. 11. View showing the sample connection to the Extension unit.
The 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”to start the same sample again or
“OK” to go on with the next sample.

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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.
4. Press the” Print” symbol for printing the results at the connected printer.
5. Individual detailed result can be shown by pressing on a selected result row.
Fig. 14 Result view. Filter the result by Day, Week, All all or Search for a specific
result.

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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.
10. Press the “Print” symbol to print the selected result on the connected printer.
11. Press the “Export” symbol to export data to as a pdf.file.
10. SAMPLE COLLECTION FOR MEASUREMENT
Breath test samples can be collected using breathbags or glass vials. Breathbags
are supplied as 0,1 L double bags 1,3 L single bags (see 2.4). Glass vials are
currently only provided with the Diabact® UBT kit.
10.1 Breathbag sample collection
1. Ensure the BreathBag is completely empty and do not have any air inside.
2. Remove the blue stopper cap from the BreathBag hose and connect a MouthPiece
to the hose.
3. Exhale into the Mouthpiece and fill the Breathbag with breath air.
4. Remove the Mouthpiece and plug in the blue stopper cap in the hose or connect the
Breathbag to the sample port for measurement.
NOTE:
Handle sampled breathbags and vials with care and avoid any damage which may
cause leakage.

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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. Follow the information stated in the chapter 7,
“Warming up”.
11.1 Error messages
Errors
Description and actions
Temperature too low,
continues
automatically
•Wait until the system continues automatically.
•If the message is still on the screen after one hour or
more please contact your local distributor.
No connection to
internal IOBoard
•Ask for changes at the network adapter-settings.
•Restart the complete system and wait at least 10
minutes without touching it.
•If the message still appears please contact your local
distributor.
No connection to
external IOBoard
•Cheeck the power cord and that the Pro-unit is
switched on
•Check the network-cable connection between Base-
and Pro-unit.
•Ask for changes at the network adapter-settings.
•Restart the complete system and wait at least 10
minutes without touching it.
•If the message still appears please contact your local
distributor.
Connection to analyser
lost
•Ask for changes at the network adapter-settings.
•Restart the complete system and wait at least 10
minutes without touching it.
•If the message still appears please contact your local
distributor.
Self test failed
•Restart the complete system and wait at least 10
minutes without touching it.
•If the message still appears please contact your local
distributor
The device is not
calibrated. Are you
sure you want to
continue?
•No valid calibration exists.
•Check the calibration status displayed at the menu-
screen in the lower right corner and perform the
required calibration.
Sample flushing
timeout
•Restart the complete system and wait at least 10
minutes without touching it.

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•If the message still appears please contact your local
distributor
Low CO2
•Check that the sample is correctly connected to the
right port.
•Restart the complete system and wait at least 10
minutes without touching it.
•If the message still appears please contact your local
distributor.
Passwords do not
match, please try
again
•First password and confirmation are not matching,
please repeat.
Password should be at
least 5 characters long
•Password to short.
Service of the device is
needed
•The service interval is defined in the settings.
•Contact your local distributor or Kibion for service by
a certified service technician.
Filter replacement is
needed
•The filter replacement interval is defined in the
settings.
•Contact your local distributor or Kibion for filter
replacement by a certified service technician.
12. SERVICE AND MAINTENANCE
Kibion recommend to perform service with an interval of 12 months to ensure safe
use and flawless function of the Kibion Dynamic devices. The service must only be
carried out by a 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
Reproducibility
<0,5‰
(standard deviation)
<0,5‰
(standard deviation)
URAS analyzer
URASmed
N/A
Sample measurement
2
(min/sample)
2
(min/sample)
Sample ports
4
16
Stability
<0,5‰
(standard deviation)
<0,5‰
(standard deviation)