PoC CD4[abs] counter w/start kit & acces

General Description:
Point-of-Care (PoC) CD4 [absolute] counter, portable, with start kit and accessories

Technical Specifications:
Functionally complete table top counter, portable for CD4 absolute count with start kit. Mainly used for ART initiation and monitoring of adults, adolescents and children living with HIV/AIDS.

Single-test processing automatic CD4 enumerator
Compact, light (2.54kg), portable to the point of patient care
Technology: fixed volume fluorescence activated cytometry
Provides absolute CD4 T-lymphocyte counts, per unit of volume
Accommodates dedicated prefilled single-use testing cartridges
Sample volume, for analysis: 25µl whole blood
Enumeration range: up to 2000 cells/µl
Accuracy: CV is below 10% at counts >200c/µl, and below 15% at counts <200c/µl
Test reading time: 20min
Large backlit alpha-numeric display (LCD) informs:
- Device operational status and on-going analysis
- Measured results in cells/µl, per patient ID, with date and time
- System errors or malfunctions, incl. insufficient sample volume
- Status built-in battery
Automated calibration with dedicated prefilled calibration cartridges
Robust and easy to clean and maintain
Design of prefilled cartridge insertion port eliminates sample cross-contamination
Cartridge insertion port fits with barcode reader
Fits with USB data interface to thermal printer
Reports: Measured CD4 results in cells/µl, per patient ID, with date and time and system errors
Memory for storage: up to 1000 test results per patient ID
Ambient operating conditions ranges:
- Operating temperature: 15 to 40C
- Relative humidity: 10 to 95% no condensing
Built-in rechargeable battery, autonomy 8hrs of continuous use or 20 test runs
Recharge time built-in battery, maximum: 8hrs
Automatic switch built-in battery / mains
Built-in voltage surge protection
Robust shock-proof housing, minimal vents enhance resistance to dust
Power requirements: Built-in battery and 100-240 (A/C) at 47-63Hz
Consumption, approximately 20W
Warranty policy: 24 months. Warranty regulations applicable to the portable PoC CD4 [abs] counter and its accessories

Manufacture product reference: 260 300 004 (Alere)

Supplied with:
1x Power adaptor/ charger with connecting cable
1x Printer
1x Instruction manual/leaflet in English, French and Spanish/Portuguese
1x Carry bag
1x Training poster, pictogram-based step-by-step CD4 count testing procedures
1x Pima CD4 100X Cartridge kit
1 x Finger Stick Sample Collection Kit for 100 Pima CD4 tests
1x Communication (connectivity pack 1)
1x External battery/cable
1 x Package insert (instructions for assembly, use and maintenance in English, French and Spanish)

Shelf life
·Cartridges: Min. 8 months - max. 12 months. Upon delivery, the cartridge kits must have minimum 8 months of the total 12 months shelf-life remaining. Do not use beyond its expiry date
·Sample collection kit: Min. 12 months -max. 24 months. Upon delivery, the sample collection kits must have minimum 12 months of the total 24 months shelf-life remaining.
·Do not use beyond its expiry date.

Storage and transportation
Between 2-30ºC, protected against humidity and direct sunlight. Do not freeze.
Do not substitute reagents from other kits/batches.
Follow strictly manufacturer instructions of the test procedure.

Note:
Follow strictly manufacturer instructions for the test procedure
***Contains hazardous materials in limited quantities. For more information refer to manufacturers Material Safety Data Sheet (MSDS).

Shipping
The manufacturer shall be responsible to comply with full extend to the most current edition of Dangerous Goods Regulations (DGR), as applicable. UNICEF shall be provided with the relevant MSDS hazardous goods shipping code in the event the quantity of hazardous materials exceeds the tolerance limit.

***Transport as per Material Safety Data Sheet***
UN number: 3481
Danger Class: 9.67
Pack. Grp: II
Proper shipping name: Lithium ion batteries contained in equipment

Weight and Volume:
Estimated weight: 11.15kg
Estimated volume: 91.9cdm