CLINICAL CHEMISTRY ANALYSER (NycoCard II)
Valid Article
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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CLINICAL CHEMISTRY ANALYSER (NycoCard II)
Please check with your OC lab referent to ensure the appropriate choice of biochemistry equipment, depending of your context
Definition
The 'NycoCard Reader II' system is a point of care instrument for quantitative determination of CRP (C-reactive protein). Battery powered reflectrometer.
Note: other parameters (D-Dimer, U-Albumin and HbA1c) can be determined on the NycoCard Reader II system, requiring other test devices. These have not been validated.
The validated use in MSF programs is patient management in orthopedic surgical programmes.
Specifications
Reader for quantitative determination of CRP that uses specific test devices (CRP NycoCard tests) to be ordered separately
Quality standards
- EN IEC 61010-1, 2010, edition 3, +2019 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN IEC 61010-2-101, 2022, edition 3, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Technical specifications
- Reader consists of 2 units: instrument box & reader pen
- Sample type: venous whole blood, serum or plasma (heparin, citrate or EDTA)
- Volume of the sample: 5 µl
- Time tor result: 30 s to 1 min
- Measurement range: 8-200 mg/l for whole blood and 5-200 mg/l for serum and plasma
- Storage data: 60 measurements with date, time and patient/sample identification, non volatile storage
- Battery powered
- No integrated printer
- Measuring conditions:
- Temperature range: 15-35°C (recommended 18-25°C)
- Relative humidity: 0-90%
- Avoid direct sunlight or too dim light
Dimensions
- Instrument box: 200 x 170 x 70 mm
- Pen: L: 144 mm, D: 29.5 mm
- Weight: 540 g (incl. rerader, pen and batteries)
- Charger dimensions (without plug): 75x32x40mm (LxWxH) and weight: 65g
Supplied with the Article
- 1 NycoCard Reader II
- 1 Battery charger (8-18 hours)
- 3 rechargeable batteries (NiMH 1.2 V, size AA)
- 10 Calibration devices
- 10 Pen tips
- 10 Pen rings
- 1 Pad
- 1 Instruction manual + warranty card
To be Ordered Separately
Tests devices and control solutions should be ordered separately
Instructions for use
Follow the instruction manual.
Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.
https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx
For offline access, contact your laboratory advisor.
Maintenance
The reader pen has three consumables; 10 units of each are supplied with the device.
- calibration device ref. 1047782 x10 [ELAECCHC311]
- pen tip ref. 1047780 x10 [ELAECCHC312]
- pen ring ref. 1047781 x10 [ELAECCHC313]
The pen tip, the pen ring and the calibration device of the NycoCard II Reader need to be exchanged on a yearly basis or when the device is dirty or damaged or if an error message related to these accessories occurs.