Accu-Chek Compact Plus Reference Manual page 2

On the packaging, on the type plate of the meter and on the finger
pricker you may encounter the symbols shown below. They have the
following meanings:
Please consult instructions for use
Catalogue number
IVD
For in vitro diagnostic use
Store at
Use by/ Expiry date
Lot number
Blood glucose meter and test strips: These products fulfil
0088
the requirements of Directive 98/79/EC on in vitro diag-
nostic medical devices.
Finger pricker and lancets: These products fulfil the re-
quirements of Directive 93/42/EEC on medical devices.
Manufacturer
Caution (refer to accompanying documents). Please refer
to safety-related notes in the manual accompanying this
instrument.
For single use only
Sterilized using irradiation
Last update: November 2005
Intended Use
Blood glucose meter for the quantitative determination of blood glucose
in fresh capillary blood using Accu-Chek Compact test strips.
Suitable for self-testing.
The Accu-Chek Compact Plus meter may be used by people with diabe-
tes to test their own blood glucose as well as for blood glucose determi-
nation by healthcare practitioners in a professional setting.
Healthcare professionals must observe additionally the directions
in Chapter 8 "Blood glucose testing in a multi-patient setting".
The Accu-Chek Softclix Plus finger pricker is intended for patient
self-monitoring by a single person.
It must not be used to collect blood in a multi-patient setting as it
does not incorporate any features to guard against cross-infec-
tion.
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 – Third Edition; CLSI
document M29-A3, 2005").
1