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Geratherm UniqueTemp° can be identified as follows:
Manufacturer’s designation:
Geratherm Medical AG
Fahrenheitstrasse 1
98716 Geschwenda
Model:
Geratherm UniqueTemp° Patient Warming System
Device/software version:
Version 1.80
Serial number:
The serial number of the control unit is to be found on the
back of the casing, on the commercial invoice and in the
attached documentation.
MPG classification:
Geratherm UniqueTemp° has been categorised as a Class
IIb device.
Geratherm UniqueTemp° meets the requirements of Coun-
cil Directive 93/42 EEC of 14.06.93 on Medical Devices
and of the standard DIN EN 60601-1 (Medical electrical
equipment, Part 1: General requirements for safety), DIN
EN 60601-1-2 (Medical electrical equipment Part 1-2: Ge-
neral requirements for safety – Collateral standard: Elec-
tromagnetic compatibility – Requirements and Tests), DIN
EN 12470-4 and DIN EN 60601-2-35 (Medical electrical
equipment, Part 2: Particular requirements for the safety
of blankets, pads and mattresses intended for the warming
of patients in medical use). A DIN EN ISO 13485 certified
quality management system ensures that these require-
ments are met and entitles the manufacturer to use the CE
0118 label.
1 Identification
