Summary of Contents for CALMARK NEO
- Page 1 Instructions for use Calmark POC - Neo POC - N ALMARK NSTRUCTIONS FOR USE Document no. | 3-55004-EN | Version 7.0 For in vitro diagnostic use IFU_Calmark_Neo_3-55004-EN_107 1 (15)
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Page 2: Table Of Contents
Instructions for use Calmark POC - Neo ONTENT Calmark POC - Neo Platform ...................... 3 Product description ........................ 3 Manufacturer ..........................3 Components ..........................4 Instrument ..........................5 Test cassette .......................... 5 Symbols used ..........................6 Unpacking POC-Analyzer ......................8 Start the system ......................... -
Page 3: Calmark Poc - Neo Platform
ALMARK LATFORM 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. -
Page 4: Components
Instructions for use Calmark POC - Neo OMPONENTS 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) IFU_Calmark_Neo_3-55004-EN_107 4 (15) -
Page 5: Instrument
Instructions for use Calmark POC - Neo NSTRUMENT Camera window Holder for test cassette Reset outlet USB outlet Charger outlet Screen On/Off button USB outlet EST CASSETTE IFU_Calmark_Neo_3-55004-EN_107 5 (15) -
Page 6: Symbols Used
Instructions for use Calmark POC - Neo YMBOLS 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... - Page 7 Instructions for use Calmark POC - Neo 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...
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Page 8: Unpacking Poc-Analyzer
Instructions for use Calmark POC - Neo POC-A NPACKING NALYZER 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. -
Page 9: Performing A Measurement
Instructions for use Calmark POC - Neo ERFORMING 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). -
Page 10: Troubleshooting
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. IFU_Calmark_Neo_3-55004-EN_107 10 (15) -
Page 11: Cleaning
RODUCT SPECIFICATIONS 17.1 NTENDED USE Calmark Neo-Bilirubin is a point of care instrument, which measures quantitatively bilirubin levels in whole blood. The device shall be used by medical staff inside hospital environment. 17.2 IRECTIVE FOR IN VITRO DIAGNOSTIC Calmark Neo-Bilirubin fulfills the directive 98/79/EC for medical technical devices and has a CE-mark. -
Page 12: Storage And Disposing
Instructions for use Calmark POC - Neo Although the performance of the POC is assured, random variations can lead to a misleading result. Always take into account that the result shall be used together with other indicators and parameters for clinical assessment and decision about treatment. -
Page 13: Limitations
Calmark POC - Neo 17.9 IMITATIONS Calmark Neo-Bilirubin can analyze samples with hemolysis up to 2 g/L and level of hematocrit up to 60 %. Tests that cannot be analyzed will be displayed as error code T1. 17.10 R EPEATABILITY Within-run precision found using 3 different blood samples and 20 replicates according to CLSI EP5-A, using results from the reference method. -
Page 14: Technical Specification
Product name Calmark Neo-Bilirubin Product description Calmark Neo-Bilirubin consist of a single-use test cassette combined with a portable instrument. Bilirubin concentration correlates to the yellow intensity developed in the filters inside the test cassette. The instrument software correlates the color intensity with the biomarker concentration. -
Page 15: Performance Specification
Instructions for use Calmark POC - Neo Test cassette Width 23.2 mm Depth 8.7 mm Height 42.1 mm Weight Approx. 2.79 g Instrument Width 120 mm Depth 210 mm Height 93 mm Weight Approx. 900 g 17.14 P ERFORMANCE SPECIFICATION...