45
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9. REFERENCE TO STANDARDS
Device standard: Device corresponds to the requirements of the
European standard for non-invasive
blood-pressure monitor
EN1060-1 / 12:95
EN1060-3 / 09:97
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP - requirements
Electromagnetic compatibility: Device fulfils the stipulations of the European
standard EN 60601-1-2
Clinical testing: The clinical performance test was carried out in
Germany according to the DIN 58130 / 1997
procedure N6 (sequential).
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa
have been fulfilled.
This device is validated by a protocol (Protocol for the evalua-
tion of blood pressure measuring) created by the British
Hypertension Society.
MEDEL CHECK has obtained, thanks to its accuracy, the
highest evaluation level:
Systolic pressure - A Degree
Diastolic pressure - A Degree
8. CARE AND MAINTENANCE, RECALIBRATION
a) Do not expose the device to either extreme temperatures,
humidity, dust or direct sunlight.
b) The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid
all types of straining through twisting or buckling.
c) Handle the tube carefully. Do not pull on it. Likewise, this is not to
be buckled or laid over sharp edges.
d) Clean the device with a soft, dry cloth. Do not use
petrol, thinners or similar solvent. Spots on the
cuff can be removed carefully with a damp cloth
and soapsuds. The cuff must not be washed!
e) Do not drop the instrument or threat it roughly
in any way. Avoid strong vibrations.
f) Never open the device! Otherwise the
manufacturer calibration becomes invalid!
Periodical recalibration
Sensitive measuring devices must from time to time be checked for accuracy. We
therefore recommend a periodical inspection of the static pressure display every 2
years.
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