Applicable standards
EN 980:
Symbols for use in the labelling of medical device
EN 60601-1:
Medical electrical equipment - Part 1: General
requirements for safety
EN 60601-1-2:
Medical electrical equipment - Part 1: General
requirements for safety. Collateral standard.
Electromagnetic compatibility
Operation
Temperature range
+10° C to +40° C
Relative humidity
30 % to 75 %, non condensing
Air pressure
70 kPa to 106 kPa
During transportation
Temperature range
-20° C to +60° C
Relative humidity
10 % to 90 %, non condensing
Air pressure
70 kPa to 106 kPa
Environmental conditions for use
11
10
13
Summary of Contents for HearCheck Screener
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