Interacoustics OtoRead Instructions For Use Manual page 63

6 General technical specifications
6.1 OtoRead TM hardware – Technical specifications
Medical
CE-mark
Standards
Cradle
Operation
environment
Transport &
Storage
environment
General
Dimensions
OtoRead
TM
OtoRead
TM
Weight
User Interface
Display Size
Data Interfaces
Language
Settings
Battery
Memory
Connector
D-0116684-B – 2020/03
OtoRead™ - 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 OtoRead is an active, diagnostic medical product according to the
TM
class IIa of the EU medical directive 93/42/EEC.
Safety:
EMC:
Calibration:
Test Signal:
OAE:
Safety:
Power:
Mains voltages and
frequencies:
Output:
Temperature:
Relative Humidity:
Ambient Pressure:
Max. altitude:
Boot-up time:
Warm-up Time:
Storage Temperature:
Transport Temperature:
Storage and Transport
rel. Humidity :
Type:
Rating:
Expected life time:
IEC 60601-1:2012 Internally powered, Type B
parts
IEC 60601-1-2:2014
ISO 389-2:1994
ISO 389-6:2006
IEC 60645-1:2012
IEC 60645-3:2007
IEC 60645-6 2009, Type 2
IEC 60601-1:2012 Class II
UE08WCP-050160SPA
100 – 240 VAC, 50/60 Hz, 400 mA
5.0V DC, 1.6A MAX
15 to 35°C, + 59°F to + 95°F
30 to 90 % (non-condensating)
98 kPa to 104 kPa
2000 m / 6561 ft above sea level
< 5 sec
< 1 minute
0°C to 50°C, 32°F to + 122°F
-20 to 50°C, - 4°F to + 122°F
10 to 95% (non-condensating)
6.6 x 3.1 x 14.5 cm / 2.25 x 1.23 x 5.78 inches
180 g / 6.4 oz.
OLED Display to provide user information and
progress of measurement. 4-button keypad to
control instrument functions
3.5 x 2.8 cm / 1.38 x 1.1 inches
Wireless and USB
English, English (UK), Chinese, Russian,
Spanish, Polish, Portuguese, Turkish, French,
German, Italian, Korean, Japanese, Arabic
Lithium-Ion rechargeable
3.7V / 1750mAh
500 tests per charge, minimum 20 hours on-
time
2 tests (one per ear) or 500 tests
Integrated USB communication capability for
battery charging and communication with PC-
based database programs or an optional
printer.
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