CALMARK NEO User manual

Instructions for use Calmark POC - Neo
IFU_Calmark_Neo_3-55004-EN_107 1 (15)
CALMARK POC -NEO
INSTRUCTIONS FOR USE
Document no. | 3-55004-EN | Version 7.0
For in vitro diagnostic use

Instructions for use Calmark POC - Neo
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1CONTENT
2 Calmark POC - Neo Platform ...................................................................................................... 3
2.1 Product description................................................................................................................ 3
3 Manufacturer ............................................................................................................................. 3
4 Components ............................................................................................................................... 4
4.1 Instrument ............................................................................................................................. 5
4.2 Test cassette .......................................................................................................................... 5
5 Symbols used.............................................................................................................................. 6
6 Unpacking POC-Analyzer............................................................................................................ 8
7 Start the system ......................................................................................................................... 8
8 Set the date ................................................................................................................................ 8
9 Set time ...................................................................................................................................... 8
10 Set unit ....................................................................................................................................... 8
11 Performing a measurement ....................................................................................................... 9
12 Show previous test result........................................................................................................... 9
13 Battery indicator......................................................................................................................... 9
14 Reset the system ........................................................................................................................ 9
15 Troubleshooting ....................................................................................................................... 10
16 Cleaning.................................................................................................................................... 11
17 Product specifications .............................................................................................................. 11
17.1 Intended use ........................................................................................................................ 11
17.2 Directive for in vitro diagnostic............................................................................................ 11
17.3 Principal for tests ................................................................................................................. 11
17.4 Calibration............................................................................................................................ 11
17.5 Safety precautions ............................................................................................................... 11
17.6 Storage and disposing .......................................................................................................... 12
17.6.1 Storage and operating conditions ................................................................................. 12
17.6.2 Disposing ....................................................................................................................... 12
17.7 Quality control ..................................................................................................................... 12
17.8 Results and measuring concentration ranges...................................................................... 12
17.9 Limitations............................................................................................................................ 13
17.10 Repeatability ........................................................................................................................ 13
17.11 Warrant................................................................................................................................ 13

Instructions for use Calmark POC - Neo
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17.12 Service.................................................................................................................................. 13
17.13 Technical specification......................................................................................................... 14
17.14 Performance specification ................................................................................................... 15
18 References................................................................................................................................ 15
2CALMARK POC -NEO PLATFORM
Thank you for choosing Calmark POC - Neo. The product platform provides a fast and easy way to
measure biomarker levels in newborns. Venous whole blood should be used. The system is adapted
to hospital environment and is intended for in vitro diagnostics.
Read this instructions for use before using the device.
2.1 PRODUCT DESCRIPTION
Calmark POC - Neo consists of an instrument and a single-use test for measurement of bilirubin
levels. The test cassette is constituted by four filters with different functions. The first two filters
which are in contact with the blood are responsible for the blood filtration. Further the plasma will
be separated and migrate through the third filter into the fourth (detection filter) by lateral flow. A
color will appear in the detection filter. A camera, inside the instrument, will take photos during the
test. The color in the detection filter will be analyzed and converted through a software into the
corresponding numeric value of the bilirubin concentration in the blood sample and presented on
the screen. All components are developed and manufactured for maximal security. If the system is
used in a different way than recommended the safety and performance can be compromised.
3MANUFACTURER
Calmark Sweden AB
Sommargatan 101A
656 37 Karlstad
Sweden
For assistance please consult:
www.calmark.se
[email protected]

Instructions for use Calmark POC - Neo
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4COMPONENTS
1. Instrument
2. Test cassette
3. Inner packaging test cassette
4. Charger
5. Outer packaging for 20 test cassettes
6. Instructions for use (this document)
5.
1.
3.
4.
6.
2.

Instructions for use Calmark POC - Neo
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4.1 INSTRUMENT
4.2 TEST CASSETTE
On/Off button
Screen
Lid
Holder for test
cassette
Camera
window
Charger outlet
USB outlet
USB outlet
Reset outlet

Instructions for use Calmark POC - Neo
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5SYMBOLS USED
In vitro diagnostic device
CE Marking
Manufacture
On/Off
Settings
Setting date and time
Setting date
Return, go back
Setting time
Setting units
Caution
Fill cavity completely
Do not underfill cavity
Do not overfill cavity
Apply blood sample here
Error, check section 15
Shows last 25 test results
Battery indicator

Instructions for use Calmark POC - Neo
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Battery too low to run a test
Battery charging
Battery empty, connect a charger
Date of manufacture
Last day for use
Catalogue number
Batch number
Do not use if the package is broken
Temperature limit
Humidity limit
Test is for single use only, do not reuse
Read the instructions for use

Instructions for use Calmark POC - Neo
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6UNPACKING POC-ANALYZER
1. Open the box and unpack the parts on a plain surface. Check that the components are
complete.
2. Make sure that there are no visible cracks or damages to the instrument.
3. Connect the charger to the instrument and to the wall outlet. Use only the charger provided.
Using a different charger might harm the instrument.
4. Charge the POC-Analyzer for at least 2 hours before it is used on battery power.
7START THE SYSTEM
Press the button while keeping the lid closed and wait until below picture is shown on the
display.
8SET THE DATE
Press the symbol on the display. Then press the symbol followed by . Set the date by
pressing the arrows up or down. Finish by pressing the symbol return until you reach the desired
menu.
9SET TIME
Press the symbol on the display. Then press the symbol followed by . Set the time by
pressing the arrows up or down. Finish by pressing the symbol return until you reach the desired
menu.
10 SET UNIT
Press the symbol . Press . Choose unit µmol/L or mg/dL. Finish by pressing the symbol return
until you reach the menu you wish.

Instructions for use Calmark POC - Neo
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11 PERFORMING A MEASUREMENT
1. Open the lid of the instrument and put
the cassette in the holder.
2. Apply a sample of venous whole blood
in the intended cavity of the test
cassette. Fill the cavity completely with
approximately 2-3 drops (at least 70
μL). Do not under- or overfill.
3. Close the lid within one minute. The
measurement starts automatically, and
a bar is shown on the display.
4. A numeric value will be presented on
the display in the end of the
measurement.
Do not open the lid during the
measurements, that will cause an
abortion of the test. If an error code
appears, read section 15 for
troubleshooting.
12 SHOW PREVIOUS TEST RESULT
Press the symbol . The system shows the last 25 test results with the latest on top of the list.
When the memory is full the oldest test result will be erased.
13 BATTERY INDICATOR
Symbol shows the instrument battery level. When the indicator is marked red , the
instrument needs to be charged before running a test.
If the symbol appears on the display, the instrument needs to be charged.
When a lightning is shown over the indicator, the battery is charging.
The instrument will turn off after 15 minutes of inactivity.
14 RESET THE SYSTEM
If the software does not respond to the user, the system can be reset by the reset outlet on the left
side of the instrument.Press with a sharp object into the outlet and wait for the instrument to
restart.

Instructions for use Calmark POC - Neo
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15 TROUBLESHOOTING
Problem
Description Cause
Action suggested
The instrument shows an
error code
Can be a temporary problem
Turn the system off, wait 30 seconds
and turn the system on again. If the
error code remains, see respective error
code.
The instrument does not
start
Battery uncharged
Connect the adapter to the instrument
and to the wall outlet. If this does not
solve the problem, contact your
distributor.
W60
Temporary malfunction of the
instrument
Turn off the instrument and wait 60
minutes, then turn the instrument on
again. If the problem persists even after
a few attempts, contact your
distributor.
R0
Malfunction of the instrument
Contact your distributor.
R1
Instrument glass surface dirty
Open the lid, remove the test cassette
and discard it. Lift up the cassette
holder.
Take a clean paper with water and soap
and/or 70% isopropyl alcohol and clean
the glass surface. Repeat test with a
new cassette. Make sure that the
cassette bottom is clean and detection
filter has no visible defects.
R100
Malfunction of the instrument
Contact your distributor.
T1
Invalid test
Open the lid, remove the test cassette
and discard it. Redo the test with a new
cassette.
Possible issues:
•detection area not filled
properly/completely due to
insufficient sample volume
•sample hemolysis
•sample level of hematocrit above
product specifications
•slow filling time (above 75 sec)
•failed blood separation – blood
leakage into the detection filter
C100
Use of an expired test cassette
Open the lid, remove the test cassette
and discard it. Redo the test with a new
cassette from a valid batch.
C101
Use of a used test cassette
Open the lid, remove the test cassette
and discard it.
Redo the test with a new cassette.
C102
Unknown test cassette
Open the lid, remove the test cassette
and discard it. Redo the test with a valid
cassette intended for Calmark Neo.