Medisana MTM Manual page 22

Upper arm blood pressure measuring device
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6 Miscellaneous
6.3
Care and
maintenance
6.4
Disposal
6.5
Directives /
Norms
18
• Remove the batteries before cleaning the unit.
• Never use strong detergents or hard brushes.
• Clean the unit with a soft cloth, moistened with mild soapy water. Do not let
water enter the unit. After cleaning, only use the unit when completely dry.
• Remove the batteries from the unit if you do not wish to use it for an
extended period of time, otherwise there is a risk of battery leakage.
• Do not expose the unit to direct sunlight, and protect it from dust and
moisture.
• Only inflate the cuff when it is in position around the upper arm.
• Servicing and calibration:
The unit has been calibrated by the manufacturer for a period of two years'
use. In the case of commercial use, the unit must be serviced and recali-
brated at least once every two years. This calibration will be charged for and
can be carried out by an appropriate authority or an authorised service
centre - in accordance with the regulations for users of medical equipment.
This product must not be disposed together with the domestic waste.
All users are obliged to hand in all electrical or electronic devices, regardless
of whether or not they contain toxic substances, at a municipal or commer-
cial collection point so that they can be disposed of in an environmentally
acceptable manner.
Please remove the battery before disposing of the equipment. Do not dispose
of old batteries with your household waste, but dispose of them at a battery
collection station at a recycling site or in a shop.
Consult your municipal authority or your dealer for information about disposal.
This blood pressure measuring unit complies with the European regulations
EN 1060 Section 1 / 1995 and EN 1060 Section 3 / 1997. DIN 58130,
NIBP – Clinical trials EANSI / AAMI SP10, NIPB requirements. The unit conforms
to the requirements of the European Norm standard EN 60601-1-2.
Clinical trial results:
Clinical trials for this unit were carried out in the USA and Germany according
to the norm DIN 58130 / 1997 proce-dure N 6 (sequential) and according to
the AAMI – Standard (US).
The requirements of the EEC Directives 93 / 42 / EEC for Class II a medical
products have been fulfilled.
The CE-mark of this device refers to the EC- Directive 93 / 42 EEC.
Device classification:
Intended use:
This unit is suitable for non-invasive blood pressure measurement in adults
(i.e., suitable for external use).
Class BF

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