Introduction - Accu-Chek Performa Instrucciones De Uso

Introduction

The Accu-Chek Performa System
The Accu-Chek Performa meter is designed to be used with the Accu-Chek Performa test strip to
quantitatively measure glucose in fresh venous, arterial, neonatal, and capillary whole blood as an aid in
monitoring the effectiveness of glucose control. Capillary whole blood for testing of blood glucose can be
obtained from fingertip and approved alternative sites (for example, forearm). Refer to the Alternative Site
Testing (AST) section of this manual for approved alternative sites and associated limitations. The Accu-Chek
Performa meter with the Accu-Chek Performa test strips provide a complete test system that is meant for in
vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The
system is not for use in diagnosis or screening of diabetes mellitus. Healthcare professional blood sample
collection and preparation is described in the test strip package insert.
For use only with the Accu-Chek Performa test strips and control solutions
Suitable for self-testing
The system includes:
• Accu-Chek Performa meter with battery
• Accu-Chek Performa test strips*
• Accu-Chek Performa control solutions*
*Some items may not be included in the kit. They are a separate purchase.
w
WARNING
Any object coming into contact with human blood is a potential source of infection
(see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline – Fourth Edition, CLSI document
M29-A4, May 2014).
w WARNING – KEEP BATTERIES OUT OF REACH OF CHILDREN
In Australia: If you suspect your child has swallowed or inserted a button battery, immediately
call the Australian 24-hour Poisons Information Centre on 13 11 26 for fast, expert advice.
Document Name: ART-07022590007
Document Number: 0000109119
Version: 1.0
This copy will not be updated. Verify the validity of this version in the appropriate electronic repository.
78120_07022590007_EN.indb 3
Introduction
Lifecycle Status: Effective
4/23/2019 1:56:35 PM
Valid from: 02-Aug-2019
Page 5 of (180) page(s)
3
Confidential