Introduction; Intended Use; User Profile; Test Principle - Abbott m-PIMA User Manual

1 INTRODUCTION

Intended Use

1
The m-PIMA™ Analyser is a portable automated bench-top analyser for
processing m-PIMA™ test cartridges. The m-PIMA™ Analyser is suited to be
used in laboratory as well as in non-laboratory environments.
The instrument is classified as in vitro diagnostic device.

User Profile

User profiles are described in detail in the respective Package Inserts (PI) of the
m-PIMA™ test cartridges.

Test Principle

An m-PIMA™ test consists of a disposable test cartridge containing both dried
reagents and liquid buffer and the m-PIMA™ Analyser.
Depending on the test cartridge used, appropriate volumes of test sample are
applied onto the cartridge.
During processing of the test, data is recorded, analysed and interpreted using
software embedded within the instrument. Upon completion of the test the
cartridge is removed from the m-PIMA™ Analyser and a test result is displayed.
For detailed information on the test principle of the individual assay, please
refer to the respective Cartridge Guides.

Data Handling

The m-PIMA™ Analyser provides for data entry (Operator, Sample ID), archiving
and connectivity to printers, data storage media and remote FTP servers.
You can save all results in the on-board archive and retrieve or download and
export them at any time after the test.
Additionally, you can print a Test Report using the attached external USB
Printer.

1 INTRODUCTION

6