m-PIMA Analyser

General description:
m-PIMA analyser is a fully automated nucleic acid testing platform. This portable analyzer enables point-of-care access to a suite of molecular assays, bypassing issues with centralized testing and reducing patient loss to follow up.

Technical specifications:
·Technology: Real Time PCR for qualitative detection of unspliced RNA for HIV-1 (M/N, O) and HIV-2.
·Runs both the m-PIMA HIV-1/2 VL and m-PIMA HIV-1/2 Detect cartridges
·Accommodates dedicated prefilled single use testing cartridges.
·Sample volume for analysis: less than 25 ul µl of capillary whole blood from finger or heel prick (neonates), venous EDTA whole blood or EDTA plasma
·Range, approximately HIV-1 (M/N, O) and HIV-2 Detected or Non-Detected
·Test reading time: Less than 70 minutes
·Built in LCD Screen graphical:
-Display with the date, time, operational status and battery status.
-Able to display result per patient ID, operator ID, error messages and warnings, malfunctions.
·Factory calibrated with autofocus of the optics each time a test is run. Quality checks include sample volume control; reagent control; automatic control of cartridge expiry date; internal process controls; automatic test identification
·Internal Controls performed with each test run. Device control checks multiple QC parameters for functionality of Alere Q system. Internal process and amplification controls. Multiple QC parameters for the analysis process
·The system has capacity to store 1000 tests in the analyser archive: unlimited tests in the data point connectivity solution.
·Single use cartridge that is capped and sealed after sample collection to contain infectious materials and eliminate the possibility of accidental reuse or cross contamination with other samples
·Power requirements: Mains Power 100-240V (A/C) at 50 - 60 Hz.
·Internal battery as back up to ensure 1 test run. External battery pack allows 8 hrs operation
·Maintenance free with no user serviceable parts. Instrument needs to be protected from dust, humidity and direct light.
·Training and Installation included
·Included Warranty: 1-year
·Extended warranty for 1 or 4 years can be purchased at any time.

Manufacture product reference: 27030R001 (Abbott Rapid Diagnostics Jena GmbH)

Items required but not included, and available separately:
·S0001274 - USB Printer (Product code: 27040R007)
·S0001298 - Connect Universal Gateway (Modem) (Product code: AC-EU-01) + UG Universal Gateway Interface (provided with Connect Universal Gateway) (Product code: 270400216)
·S0001234 - Printer Paper I (Product code: 26040R009)
·S0001299 - Energy.case 05.24V (Product code: 5100643)

Storage and transportation instructions:
2-30°C

Weight and volume:
Estimated weight: 6.00kg
Estimated volume: 0.048m3

Transport as per Material Safety Data Sheet (MSDS):
UN number: 3481
Danger Class: 9
Pack. Grp: II
Proper shipping name: Lithium-ion batteries contained in equipment