Interacoustics OtoRead - Page 63

D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 57
6 General technical specifications
6.1 OtoRead
TM
hardware – Technical specifications
Medical
CE-mark
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
TM
is an active, diagnostic medical product according to the
class IIa of the EU medical directive 93/42/EEC.
Standards
Safety:
IEC 60601-1:2012 Internally powered, Type B
parts
EMC:
IEC 60601-1-2:2014
Calibration:
ISO 389-2:1994
ISO 389-6:2006
Test Signal:
IEC 60645-1:2012
IEC 60645-3:2007
OAE:
IEC 60645-6 2009, Type 2
Cradle
Safety:
Power:
Mains voltages and
frequencies:
Output:
IEC 60601-1:2012 Class II
UE08WCP-050160SPA
100 – 240 VAC, 50/60 Hz, 400 mA
5.0V DC, 1.6A MAX
Operation
environment
Temperature:
Relative Humidity:
Ambient Pressure:
Max. altitude:
Boot-up time:
Warm-up Time:
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
Transport &
Storage
environment
Storage Temperature:
Transport Temperature:
Storage and Transport
rel. Humidity :
0°C to 50°C, 32°F to + 122°F
-20 to 50°C, - 4°F to + 122°F
10 to 95% (non-condensating)
General
Dimensions
OtoRead
TM
6.6 x 3.1 x 14.5 cm / 2.25 x 1.23 x 5.78 inches
OtoRead
TM
Weight
180 g / 6.4 oz.
User Interface
OLED Display to provide user information and
progress of measurement. 4-button keypad to
control instrument functions
Display Size
3.5 x 2.8 cm / 1.38 x 1.1 inches
Data Interfaces
Wireless and USB
Language
Settings
English, English (UK), Chinese, Russian,
Spanish, Polish, Portuguese, Turkish, French,
German, Italian, Korean, Japanese, Arabic
Battery
Type:
Lithium-Ion rechargeable
Rating:
3.7V / 1750mAh
Expected life time:
500 tests per charge, minimum 20 hours on-
time
Memory
2 tests (one per ear) or 500 tests
Connector
Integrated USB communication capability for
battery charging and communication with PC-
based database programs or an optional
printer.