PoC CD4 [abs],counter with start kit

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

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), easily 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 of whole blood
Enumeration range, approximately up to 2000 cells/µl
Accuracy: CV is below 10% at counts >200c/ul, and below 15% at counts <200c/ul
Test reading time: 20 min
Large backlit alphanumeric display (LCD) informs:
- Device operational status and on-going analysis
- Measured results in cells/ul, per patient ID, with date and time
- System errors or malfunctions, incl. insufficient sample volume
- Status built-in battery
Factory calibrated and built-in auto-self-test, each time the device is switched-on
Robust, easy to clean and maintain
Design of prefilled cartridge insertion port, eliminates sample cross-contamination
Fit 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 approximately 1000 test results per patient ID
Ambient operating conditions ranges:
- Operational temperature: 15 to 40°C
- Relative humidity: 10 to 95% not condensing
Built-in rechargeable battery, autonomy 8 hrs of continuous use or 20 test runs
Automatic switch built-in battery / mains
Built-in voltage surge protection
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: 260 300 003 (Alere)

Supplied with:
1 x Pima Analyser;
1 x Pima AC/DC transformer with connecting cable);
1 x Pima External Printer;
1 x User manual in English, French, Portuguese, Spanish;
1 x Pima bag
1 x Pima transport box
1 x Training in a Box Set with user guide
1 x Cartridges (100 tests)
1 x Sample collection kit (100 tests)
1 x Pima Bead Standard;
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.
·Bead Standard: 24 months. Upon delivery, the beads must have minimum 19 months of the total 24 months shelf-life remaining. Note: 6 months expiry from date of first use.
·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).

Packaging and Labeling:
Primary packaging
Unit presentation: 1 (one) PoC CD4[abs], counter, portable, with start kit and instructions for use

Packaging and labelling must meet essential requirements in conformity with international quality management system standards, norms, rules and regulations for medical devices. Refer to UNICEF Technical Provisions for Medical Devices- March 2014


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: 9.25kg
Estimated volume: 82.4cdm