D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN
Page
69
7
General technical specification
7.1 Sera
TM
instrument – 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 no. 0123.
Standards
Safety:
IEC 60601-1:2012, Internally powered, Type B and BF
applied parts
EMC:
IEC 60601-1-2:2014
IEC 60601-2-40:2016
Calibration:
ISO 389-2:1994
ISO 389-6:2007
Test Signal:
IEC 60645-3:2007
OAE:
IEC 60645-6:2009, Type 2
ABR:
IEC 60645-7:2009, Type 2
Cradle
Safety:
Power
Mains voltages and
frequencies:
Output:
IEC 60601-1:2012, Class II
UES12LCP-050160SPA Item number 8515473
100 – 240 V~, 50/60 Hz, 400 mA
5.0V DC, 1.6A MAX
Operation
environment
Temperature:
Relative Humidity:
Ambient Pressure:
Boot-up time:
Warm-up Time:
5 – 40
°
C, + 41°F... + 104°F
15 – 93% (non-condensing)
98 kPa – 104 kPa
< 5 sec
Nil
Transport & Storage
environment
Storage Temperature:
Transport
Temperature:
Storage and Transport
rel. Humidity:
0
°
C – 50
°
C, - 4°F... + 122°F
-25 – 70
°
C, - 13°F... + 158°F
Max 93% (non-condensing)
Altitude rating
Max. operating altitude:
2000 m / 6561 ft above sea level
Markings
IP02
IP20
IP marking is an ingress protection marking. The marking specifies the protection
provided against ingress of particle matter and liquids. This instrument has
different IP marking with the follow impact:
IP02: To protect the instrument against rain and water always use the carrying bag
during transport.
IP20: This marking can be found on the instrument parts meaning that the parts
are not protected against water
NOTE: The charger, power supply and cradle are not to be used in home
healthcare environments.
