Reer Colour SoftTemp Notice D'utilisation page 32

cleaning agents on the sensor. Clean the housing and display using a soft, dry
cloth or an alcohol pad. The device is not waterproof and must therefore not be
allowed to be immersed in water or directly exposed to moisture. Remove the
batteries from the unit if it is to be out of use for a longer period. This product
does not require any special maintenance. Any repairs made to the unit must be
carried out by a qualified professional.
Metrological control
As a rule, checking the thermometer's precision is not required. For devices used
in Germany for medical practice, the Medical Products Operator Ordinance of
29 June 1998 (in the version announced on 21 August 2002, last amended by
Article 4 of the law of 29 July 2009) requires metrological control after 2 years.
Legal basis for placing on the market in the EU
The manufacturer has been certified by the EU notified body TÜV SÜD Produkt
Service GmbH in line with the 93/42/EEC Directive on Medical Devices. This de-
vice complies with the European standard EN60601-1-2 for electromagnetic com-
patibility and ASTM E 1965 "Standard Specification for Infrared Thermometers for
Intermittent Determination of Patient Temperature".
This product complies with the following standards for medical electrical
equipment:
• IEC 60601-1-2:2014
• IEC 60601-1:2012
• ISO 80601-2-56: 2009
• IEC 61000-4-2
• IEC 61000-4-8
• IEC 61000-4-3
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