General Technical Specification; Sera Tm Instrument - Technical Specifications - Interacoustics Sera Instructions For Use Manual

7 General technical specification

Sera TM instrument – technical specifications
Medical CE-
mark
Standards
Cradle
Operation
environment
Transport & Storage
environment
Altitude rating
Markings
IP02
IP20
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II
of the Medical Device Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
The Sera is an active, diagnostic medical product according to the class IIa of
TM
the EU medical directive 93/42/EEC.
Safety:
EMC:
Calibration:
Test Signal:
OAE:
ABR:
Safety:
Power
Mains voltages and
frequencies:
Output:
Temperature:
Relative Humidity:
Ambient Pressure:
Boot-up time:
Warm-up Time:
Storage Temperature:
Transport
Temperature:
Storage and Transport
rel. Humidity:
Max. operating altitude: 2000 m / 6561 ft above sea level
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.
IEC 60601-1:2012, Internally powered, Type B and BF
applied parts
IEC 60601-1-2:2014
IEC 60601-2-40:2016
ISO 389-2:1994
ISO 389-6:2007
IEC 60645-3:2007
IEC 60645-6:2009, Type 2
IEC 60645-7:2009, Type 2
IEC 60601-1:2012, Class II
UE08WCP-050160SPA Item number 8029254
100 – 240 V~, 50/60 Hz, 400 mA
5.0V DC, 1.6A MAX
5 – 40°C, + 41°F... + 104°F
15 – 93% (non-condensing)
98 kPa – 104 kPa
< 5 sec
Nil
0°C – 50°C, - 4°F... + 122°F
-25 – 70°C, - 13°F... + 158°F
Max 93% (non-condensing)
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