Interacoustics Luna - General technical specifications; Technical specifications

D-0128842-E – 2023/10
Luna - Instructions for Use - US Page 35
5 General technical specifications
Medical CE-mark:
The CE-mark in combination with MD symbol indicates that Interacoustics A/S
meets the requirements of the Medical Device Regulation (EU) 2017/745. Approval
of the quality system is made by TÜV – identification no. 0123.
Standards: Safety:
IEC 60601-1 2005/EN 60601-1 2006 and A1 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Type B applied parts
EMC:
IEC 60601-1-2 (2014)+AMD1:2020
Audiometer Tone:
Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2018),
Type 4
Construction:
Plastic cabinet.
Power: USB-powered
Average: 300mA (Max: 500mA)
Operation environment:
Ambient noise: The Luna audiometer should be used in a quiet place such
as a separate room
Rel. Humidity:
Temperature:
Ambient Pressure:
15 – 90%
10-35°
98 kPa – 104 kPa
Transport
temperature:
-20-50 °C
Storage
temperature:
0-50 °C
Humidity
transportation &
storage:
10% to 95% RH. Noncondensing