Important Notes; Measurement Accuracy - Labtron 847 Manual

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Important Notes

Only a physician is qualified to interpret changes in
your blood pressure.
This device is not intended to
replace regular medical examinations.
mended that your physician review your procedure for
using this monitor. Never make adjustments to your
medication unless it is the advice of a physician.
This Blood Pressure Monitor is intended for use by
adults. Children should not use this monitor unless it
is under the supervision of an adult.
Please read the entire instructions carefully before
using this Blood Pressure Monitor.

Measurement Accuracy

The blood pressure measuring device bears the CE
(conformity) label "CE 0044". The quality of the device
It is recom-
has been verified and conforms to the provisions of
the EC council directive 93/42/EEC of 14 June 1993
on medical devices, as well as the EMC directive 89
/336/EEC:
EN 1060-1
Non-invasive blood pressure measuring equipment
General requirements
EN 1060-3
Non-invasive blood pressure measuring equipment
Supplementary requirements for electro-mechanical
blood pressure measuring systems
EN 60601-1
Safety requirements for medical electrical equipment
EN 60601-1-2
Electromagnetic compatibility and safety for medical
electrical equipment
EN 14971
Risk analysis for medical devices
2

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