10
6 Miscellaneous
GB
6.3 Cleaning and maintenance
• 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 it is 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 mois-
ture.
• 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 recalibrated
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 accor-
dance with the regulations for users of medical equipment.
6.4 Disposal
This product must not be disposed of together with 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 commercial collection point so that they can be dis-
posed of in an environmentally acceptable manner. Remove the
batteries before disposing of the device/unit. Do not dispose of old
batteries with your household waste, but at a battery collection
station at a recycling site or in a shop. Consult your municipal authority or your
dealer for information about disposal.
6.5 Guidelines / Standards
This blood pressure monitor meets the requirements of the EU standard for non-
invasive blood pressure monitors. It is certified in accordance with EC Guidelines
and carries the CE symbol (conformity symbol) “CE 0297”.
The blood pressure monitor corresponds to European standards EN 60601-1,
EN 60601-1-2, EN 1060-1/-3/-4, EN ISO 14971 and EN 980.
The specifications of EU Guideline “93/42/EEC of the Council Directive dated 14
June 1993 concerning medical devices” are met.
Clinical trial results:
Clinical trials for this unit were carried out in the USA and Germany according to
EN 1060-4 and according to the AAMI – Standard (US).
Electromagnetic compatibility:
The device complies with the EN 60601-1-2 standard for electromagnetic com-
patibility. Inquire at MEDISANA for details on this measurement data.
Intended use:
This unit is suitable for non-invasive blood pressure measurement in adults (i.e.,
suitable for external use).
51047_MTP_MiniFormat_NEUSS19.qxd:OA-Blutdruckmessgerät 06.06.2012
