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Instructions for use

Calmark POC - Neo

IFU_Calmark_Neo_3-55004-EN_107

1 (15)

C

ALMARK

POC

-

N

EO

I

NSTRUCTIONS FOR USE

Document no. | 3-55004-EN | Version 7.0

For

in vitro diagnostic

use

1
2
3
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»

Summary of Contents for NEO

Page 1: ...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...

Page 2: ...ng 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...

Page 3: ...r 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...

Page 4: ...lmark POC Neo IFU_Calmark_Neo_3 55004 EN_107 4 15 4 COMPONENTS 1 Instrument 2 Test cassette 3 Inner packaging test cassette 4 Charger 5 Outer packaging for 20 test cassettes 6 Instructions for use thi...

Page 5: ...ns for use Calmark POC Neo IFU_Calmark_Neo_3 55004 EN_107 5 15 4 1 INSTRUMENT 4 2 TEST CASSETTE On Off button Screen Lid Holder for test cassette Camera window Charger outlet USB outlet USB outlet Res...

Page 6: ...gnostic 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 overfil...

Page 7: ...y 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 Humidi...

Page 8: ...is used on battery power 7 START THE SYSTEM Press the button while keeping the lid closed and wait until below picture is shown on the display 8 SET THE DATE Press the symbol on the display Then press...

Page 9: ...n 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 f...

Page 10: ...der 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...

Page 11: ...the feces and urine present high levels of unconjugated bilirubin leading to jaundice1 More than 60 of the newborns will be diagnosed with jaundice the first week after birth Frequently it disappears...

Page 12: ...n safe use make sure to 1 Always place the instrument on a stable and flat surface 2 Never disassemble the instruments housing 3 Use only the supplied battery charger for the instrument 17 6 STORAGE A...

Page 13: ...ilable bilirubin controls according to CLSI EP5 A Sample ID CV Days Low Control 14 0 20 Medium Control 11 8 20 Bias the mean values have been calculated and grouped into three concentration groups The...

Page 14: ...ulatory status CE marked Operating environment Temperature 18 28 C 64 4 82 4 F Humidity 20 80 RH Storage environment instrument Temperature 10 40 C 50 104 F Humidity 10 90 RH Safety classification Acc...

Page 15: ...nce levels No interference with hemolysis in samples up to 2 g L Sample hematocrit Handles samples with hematocrit up to 60 Anticoagulants interference The product can handle up to 18 U L lithium hepa...

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