Instruction for Use IRIS Dynamic

Instruction for Use
IRIS Dynamic
Base unit and the extension unit Pro
REF 8031
REF 8032
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 1(18)
TABLE OF CONTENTS
1.
INSTALLATION ......................................................................................................... 3
2.
PREFACE .................................................................................................................. 4
2.1
2.2
2.3
2.4
2.5
INTENDED USE AND CLASSIFICATION ............................................................................... 4
INFORMATION CONCERNING GENERAL USE, CAUTION, DISINFECTION .................................. 4
SCOPE OF SUPPLY ........................................................................................................ 4
ACCESSORIES .............................................................................................................. 5
MOVING ....................................................................................................................... 5
3.
INITIAL OPERATION ................................................................................................ 6
3.1 INTERFACES ................................................................................................................. 6
3.2 OPERATION/HANDLING .................................................................................................. 6
4.
MEASUREMENT ....................................................................................................... 7
4.1 CALIBRATIONS .............................................................................................................. 7
4.2 MEASURING SAMPLES ................................................................................................. 11
4.3 RESULTS ................................................................................................................... 14
5.
SAMPLE COLLECTION .......................................................................................... 15
6.
TROUBLESHOOTING ............................................................................................. 15
7.
SERVICE AND MAINTENANCE ............................................................................. 15
8.
DISPOSAL ............................................................................................................... 15
9.
TECHNICAL INFORMATION .................................................................................. 16
9.1 ANALYTIC DATA .......................................................................................................... 16
9.2 TECHNICAL DATA ........................................................................................................ 16
9.3 ENVIRONMENTAL WORKING CONDITIONS (LABORATORY CONDITIONS) .............................. 16
10. ADDENDUM ............................................................................................................ 17
10.1 „DELTA“ AND “DOB” – VALUE; DEFINITION AND COMMENTS: ............................................ 17
10.2 EVALUATION OF DATA AND EXPLANATION ...................................................................... 17
11. CONTACT DETAILS ............................................................................................... 18
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 2(18)
PLEASE NOTE:
In order to preserve the protection afforded by the equipment, please read this
IfU prior to any handling of the equipement.


1.
If the equipment is used in a manner not specified in this IfU, the protection
provided by the equipement may be impaired.
INSTALLATION
0B
 The IRIS Dynamic must be placed on stable and even surface.
 Connect the IRIS Dynamic with the delivered power cable to a grounded power
supply.
 The power plug must be accessible to disconnect power in a case of emergency.
 The IRIS Dynamic must not be covered to assure circulation of fresh air around the
instrument. To assure this a space of 20 cm should be left to all sides, the back and
top of the instrument.
 IRIS should be operated under laboratory conditions - see details in „Technical
information“.
 Protect the unit against vibration during calibration and measurement by placing the
IRIS Dynamic on a solid table or rack in an area where no disturbances occur.
 IRIS must be used stationary.
 Only applicable for the IRIS Dynamic pro:
o Place the IRIS Dynamic pro within 50 cm distance to the IRIS Dynamic base.
o Connect the IRIS Dynamic pro with the delivered power cable to a grounded
power supply.
o The power plug must be accessible to disconnect power in a case of
emergency.
o Connect the gas tube to the connector on the backside of the IRIS Dynamic
pro. Connect it then to the middle tube connector on the IRIS Dynamic base.
o Connect the delivered network cable to the Ethernet port on the IRIS Dynamic
pro and the Ethernet port next to the center of the IRIS Dynamic base.
WARM-UP PHASE
After turning on the power supply, the system needs at least 12 hours before it has
reached a constant temperature.
PLEASE NOTE
The Iris device may not be switched off after the "warm-up phase" any more, when
in routine use.
The specifications can be reached only if the device has reached the final
temperature.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 3(18)
2.
PREFACE
1B
2.1 Intended use and classification
10B
IRIS is an InfraRed ISotop Analyser for 13C breath gas. (Infrarot Isotopen
Analysator für 13C Atemgasanalyse).
IRIS is used for comparison of the isotope ratio 13C/12 C in breath samples for IVDpurposes.
Intended user
The device is used by trained staff, mostly in hospital and or laboratory environment.
Classification
The device is classified according to the Medical Devices Directive on in vitro
diagnostic medical devices (MDD 98/79/EC) as “IVD-other” type.
IRIS Dynamic Pro (if applicable)
Intended use:
IRIS Dynamic pro is used to extend the capacity of the IRIS Dynamic base.
Classification:
The IRIS Dynamic pro unit is an accessory to the base unit and shall be treated as in
vitro diagnostic medical devices in their own right.
(Ref in DIRECTIVE 98/79/EC)
2.2 Information concerning general use, caution, disinfection
1B
The device is intended for the exclusive use with Breath samples.
Protective gloves should be used while handling human samples.
The device is not suitable for use in the presence of explosive gases, flammable,
anesthetic gases mixed with air, oxygen or nitrous oxide.
The device can be cleaned and disinfected from the outside with a dry cloth. No
disinfectant containing ammonia or acetone should be used.
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.
2.3 Scope of supply
12B




IRIS Dynamic base (checked and prepared for operation)
Power cable
Instruction for use
If applicable:
o IRIS Dynamic pro
o Power cable
o Tube
o Network cable
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 4(18)
2.4 Accessories
13B
 IRIS Breath bag; REF. No. 8005; with 2 x ca. 0,1 l volume with connecting hose
for single use; disposal as packaging garbage.
 IRIS Breath bag; REF. No. 8004; with 1 x ca. 1,0 l volume with connecting hose
for single use; disposal as packaging garbage.
 Mouthpiece for the IRIS breathbag; REF. No.8007; with one-way valve as hygiene
barrier for single use (material PE, hygienically packed), disposal as a packaging
garbage.
 Glas vials for breath samples with fixed cap (up to 17 mm in diameter with at least
10 mL volume).
 IRIS Dynamic Fuses: T2AH250VAC, IEEC/EN60127-2/5, 5*20mm
2.5 Moving
14B
Turn off the system and unplug it.
Transportation of the system must be done in horizontal position.
No physical shocks should occur.
After moving, the device should be installed like a new system.
If the IRIS Dynamic has to be transported, please contact your local distributor for
further information.
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Doc. No; Br-328/09
Date; 2016-01
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3.
INITIAL OPERATION
2B
3.1 Interfaces
15B
The IRIS Dynamic base holds 2 USB ports for multiple usages. It is possible to
connect HID-Devices, if these are plug & play compatible to Windows 7. Also it is
possible to connect printers directly to the instrument.
The IRIS Dynamic base also has 2 RJ-45 connectors. These are for connections to
local LIS-systems. Please contact your local distributor for assistance.
The IRIS Dynamic pro holds one Ethernet connector for communication with the
base-unit and one gas connector for being connected with the base unit as well.
3.2 Operation/handling
16B
The IRIS Dynamic GUI is touchscreen based. All user inputs are conducted directly
via the screen.
For inputs the GUI offers an on-screen keyboard, which can be opened by pressing
the symbol below.
Printing can be conducted from various screens by pressing the symbol below.
If applicable the following symbol will conduct an export of the shown content to an
attached standard USB-stick.
After switching the IRIS Dynamic on, a log-in-screen will appear. The default user is
“Max Mustermann” with the password “1234567”.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
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After logging in the central menu-screen will appear.
From this screen all major functions of the instrument can be accessed.
4.
MEASUREMENT
3B
4.1 Calibrations
17B
Before conducting measurements calibrations have to be performed. An automatic
calibration of the system is conducted automatically on every first use after 24 or
more hours and will be performed without further notice.
The operator has to perform 2 different kinds of calibration which are:
 The daily calibration – every day
 The monthly calibration every 30 days
Without valid calibrations the system will reject to measure and will show a message,
pointing at the missing calibrations.
For performing the reference calibrations the operator has to select “Calibration” on
the main screen. The system will switch to the calibration screen.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
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To perform the daily calibration the user has to exhale normal breath into a breath
bag and connect it to sample port 1 – which is the port on the left side. After
selecting the daily calibration button from the calibration menu the system will show
a pictogram to guide the operator in performing the daily calibration.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 8(18)
After connecting the breath bag to port one, pressing the arrow will start the
calibration process, showing a progress bar.
After finishing the calibration successful the system will show a message.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
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The monthly calibration works in a similar way, with the difference, that the operator
needs to hold her or his breath for about 30 seconds before exhaling into a breath
bag (preferably a big breath bag with 1 litre volume), which is then also connected to
port 1.
This calibration will take about 35 minutes and will also show the aforementioned
message after finish.
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Doc. No; Br-328/09
Date; 2016-01
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4.2 Measuring samples
18B
After selecting “analysis” in the main menu, the following screen will appear.
This screen allows to enter a test identifier either via the on-screen keyboard or by
scanning with a bar code scanner.
Also a sample ID can be optionally assigned.
The lower line allows to select defined test types from a drop-down menu.
If applicable here it can be chosen whether to run the analysis on the base unit or
the Extension Unit IRIS Dynamic pro.
Pressing the right arrow key opens the patient screen.
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Doc. No; Br-328/09
Date; 2016-01
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This screen allows to enter specific patient data for the internal database. All fields
are optional. Pressing the right arrow opens a pictogram, showing on which sample
ports the system expects the breath bags. Below shows the screen for tests on the
base unit:
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Doc. No; Br-328/09
Date; 2016-01
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On the IRIS Dynamic Pro this screen shows another pictogram:
After pressing the right arrow, the measurement starts and a status screen is
showing the progress.
While the measurement is running, additional analysis can be initiated the same way
as described above.
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Date; 2016-01
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4.3 Results
19B
Pressing the result-button in the main menu will open the result database.
By pressing “Day”, “Week” or “All” the shown results can be filtered. A search can be
conducted in the upper right corner. Pressing the second button in the top right
corner will print the results to a connected printer.
Selecting a result will open a detailed view of it.
This screen shows either graphical or listed (selectable on top) the details of the
specific selected result. It also allows printing out the details to a connected printer.
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Doc. No; Br-328/09
Date; 2016-01
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5.
SAMPLE COLLECTION
4B
Breath bag should be emptied completely. Connect a mouthpiece to the bag, the
patient should blow up the bag, then keep the bag filled by connecting the small blue
stopper to the hose or connect the bag directly to the corresponding hose port. The
mouthpiece can be used for other samples of the same patient and has to be
disposed after usage. Bags can be stored for up to 1 week.
6.
TROUBLESHOOTING
5B
In case of a malfunction, please call your local distributor.
In case of a power black-out, please make sure to let the IRIS Dynamic warm up for
at least 12 hours before use.
SERVICE AND MAINTENANCE
7.
6B
Kibion recommends a service every 12 months for the flawless function of the Iris
device. The service should only be carried out by a Kibion technician or a technician
certified and authorized by Kibion.
Projected lifetime of the device is 10 years.
8.
DISPOSAL
7B
The device contains electronic printed circuit assemblies. It should be disposed in
accordance with any applicable national or local policies relating to obsolete
electronic equipment.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
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9.
TECHNICAL INFORMATION
8B
9.1 Analytic data
20B
Reproducibility
URAS analyzer
Sample measurement
Sample ports
Stability
IRIS Dynamic base
<0,5‰
(standard deviation)
URASmed
2
(min/sample)
4
<0,5‰
(standard deviation)
IRIS Dynamic pro
<0,5‰
(standard deviation)
N/A
2
(min/sample)
16
<0,5‰
(standard deviation)
IRIS Dynamic base
280 * 320 * 380 (mm)
IRIS Dynamic pro
500 * 320 * 380 (mm)
13 (kg)
11,5 (kg)
100-120/200-240 (VAC)
50-60 (Hz)
0,12(kW)
100-120/200-240 (VAC)
50-60 (Hz)
0,12(kW)
2x2A
2x2A
1 gas connection
1 gas connection
2 RJ-45, 2 USB
1 RJ-45
9.2 Technical data
21B
Width * Height * Depth
Weight
Electrical connections
Power consumption
Mains switch with two
fuses
Gas connections
Data transfer
9.3 Environmental working conditions (laboratory conditions)
2B
Temperature
IRIS Dynamic base
and pro
15 - 35 (°C)
Humidity rH
<70 (% rH)
At the place where the IRIS system is installed there should be no vibrations or
other movements (shock).
Please do not place anything on top of the system.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 16(18)
10. ADDENDUM
9B
10.1 „Delta“ and “DOB” – value; definition and comments:
23B
The „Delta“-value of a breath sample Rs describes the 13C/12C-ratio at the carbon
dioxide of the particular breath sample in relation to the 13C/12C-isotope ratio of the
world wide accepted carbon isotope standard X „PD-Belemnite“ (PDB) - carbonate
material with its 13C/12C-ratio stated as RPDB = 0,0112372 .
“Delta“ = (( RS / RPDB) - 1) x 1000 ( ‰ ) “Delta per mille”
The “Delta Over Base”- value = “DOB”-value describes the change of the „Delta“value at the CO2 of the breath gas, which at a certain time after the ingestion of a
13
C-labelled substrate will develop, related to that Basal-Delta-value, which was
measured at the individuals breath prior to the ingestion of the 13C-labelled
substrate.
Basal-Delta-values at the CO2 in human breath worldwide are between - 28.0 and 23.0 Delta per mille. In essence, these 13C/12C-ratios are by 28.0 to 23.0 per mille
lower than the 13C/12C-ratio of the PDB-carbon isotope standard.
„DOB“ = deltasample – deltabasal
10.2 Evaluation of data and explanation
24B
A test should not be evaluated if the sign “too low CO2” is shown in the result
window.
Values shown in the database should be plausible, discard the particular test
otherwise.
Plausible values:
In case of implausible values, the correct placement of samples to the connectors
should be checked.
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 17(18)
This instruction for use is valid for a device with the following label;
(only applicable for the IRIS Dynamic pro)
11. CONTACT DETAILS
Local Distributor contact details
(if applicable)
Kibion GmbH
Haferwende 31
28357 Bremen
Germany
E-Mail: support @kibion.com
Tel.: +49 (0) 421 27 86 5-0
Fax: +49 (0) 421 27 86 5-20
Doc. Title; Instruction for Use
Doc. No; Br-328/09
Date; 2016-01
Page 18(18)
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