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Markings
This is the labelling of Humantechnik GmbH for a medical product according to EU 2017/745.
This is the marking for the product identification number to identify the medical device.
This is the marking for the serial number to identify the medical device. This is indicated
on the device and the packaging.
This is the identification for the manufacturer's item number.
This is the marking for manufacturer of the medical device.
This symbol indicates the production date of the medical device.
This is the marking of the country of production of the medical device. This is shown on
the device and the packaging.
This symbol indicates distributors for the medical device.
This symbol indicates that the user should read these operating instructions attentively.
This sign indicates warnings that are important for the user as well as important information on use and
operational safety.
Temperature range for transport and storage: -5°C to 40°C
Temperature range for operation: 10°C to 30°C, i optimum ambient temperature: 25°C
Humidity during transport and storage: < 90% (non-condensing)
Operating humidity: 15% to 90% (non-condensing)
Atmospheric pressure range during transport, storage and operation: 700 hpa to 1060 hpa
This mark indicates that this appliance does not require sterilisation.
The CE mark on the device confirms conformity with the European requirements of the
Medical Device Regulation (2017 / 745 / EU Medical Device Directive (MDR)).
- 2011 / 65 / EC + 2015 / 863 / EC RoHS-Directive
- 2012 / 19 / EC WEEE-Directive
- 2014 / 53 / EC RED-Directive
Complete declarations of conformity are available on the Internet at www.humantechnik.com in the service area.
Hereby, Sarabec Ltd declares that this device complies with all relevant UK Statutory Instruments. The full
declarations of conformity for this device are available from:
Sarabec Ltd., 15 High Force Road, MIDDLESBROUGH TS2 1RH. UK.
Sarabec's EU authorised representative: HUMANTECHNIK GmbH, Im Wörth 25, D-79576 Weil am Rhein, Germany
All serious incidents must be reported to the manufacturer and the according local
authority)!
Technical specifications may be subject to change without prior notice.
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