28
Ambient conditions Operation
Temperature
+5° to +45° Celsius
Humidity
<65%
Transport and storage
Temperature
-10° to +45° Celsius
Humidity
< 65%
Requirements
Medical Devices Ordinance
EU 2017/745
Product life
7 years as medical device
Stationary training equipment
EN ISO 20957-1, ISO 20957-2
Use class according to ISO 20957-1
S/I
Risk classification
93/42/EEC
Class IIa
EU 2017/ 745
Class IIa