Introduction - Accu-Chek Active GB User Manual

Introduction

Introduction
The Accu-Chek Active Blood
Glucose Meter
The Accu-Chek Active blood glucose meter
is intended to be used for quantitative blood
glucose tests in fresh capillary blood. The
meter may only be used together with the
Accu-Chek Active test strips. Consult the
package insert of the test strips if you
intend to use different sample material.
The blood glucose monitoring system
comprises the meter and test strips and is
suitable for self-testing and for professional
use. People with diabetes can use this
system to self-test their blood glucose.
Healthcare professionals can use this
system to check patients' blood glucose
values and they can use it in suspected
cases of diabetes and in emergency
diagnostics.
The system is suitable for testing blood
glucose with blood obtained from alternative
sites.
The system must not be used to diagnose or
rule out diabetes.
The system is only suitable for use outside
the body.
Visually impaired persons must not use the
meter.
The system does not require a code chip.
The meter must only be used for its
intended purpose; if used otherwise
preventive measures could be ineffective.
WARNING
W
• Choking hazard. Small
• Keep new and used batteries away from
children. Ingestion or insertion into the
body may cause chemical burns,
perforation of soft tissues, and death.
Severe burns may occur within 2 hours
of swallowing. If you think a battery
might have been swallowed or placed
inside any part of the body, seek
medical attention immediately.
• If the battery compartment does not
close securely, stop using the product
and keep it away from children. Contact
Roche.
• 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).
• Healthcare professionals must also read
the instructions and notes in the Testing
in More Than One Patient chapter.
• There is a risk of infections (e.g.
hepatitis B, hepatitis C, HIV) being
transmitted if the meter is used by other
people, even family members, or if
healthcare professionals use the same
meter to test blood glucose in more than
one person.
• Only use the Accu-Chek Active meter
with Accu-Chek Active test strips that
are approved by Roche. Other test strips
deliver incorrect results.
2
parts. Keep away from
children under the age of
3 years.