General Technical Specifications - Interacoustics OtoRead Instructions For Use Manual

OtoRead™ Instructions for Use - US

6 General technical specifications

TM
OtoRead hardware – Technical specifications
Medical CE- The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical
mark Device Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
The Sera
directive 93/42/EEC.
Standards Safety:
EMC:
Calibration:
Test Signal:
OAE:
Cradle Safety:
Power:
Mains voltages and
frequencies:
Output:
Operation environment Temperature:
Relative Humidity:
Ambient Pressure:
Max. altitude:
Boot-up time:
Warm-up Time:
Transport & Storage Storage Temperature:
environment
Transport Temperature:
Storage and Transport rel.
Humidity :
General
TM
Dimensions OtoRead
TM
OtoRead Weight
User Interface
Display Size
Data Interfaces
Language Settings
Battery Type:
Rating:
Expected life time:
Memory
Connector
Micro-Probe Microphone System Noise:
Dimensions and Weight:
Connector:
TM
is an active, diagnostic medical product according to the class IIa of the EU medical
IEC 60601-1, Internally powered, Type B parts
IEC 60601-1-2
ISO 389-2
ISO 389-6
IEC 60645-1
IEC 60645-3
IEC 60645-6 2009, Type 2
IEC 60601-1, 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
Wireless and USB
Lithium-Ion rechargeable
3.7V / 1750mAh
500 tests per charge, minimum 20 hours on-time
Integrated USB communication capability for battery charging
and communication with PC-based database programs or an
optional printer.
HDMI Connector for connection to the Micro-Probe
Integrated Wireless (Bluetooth® Class 2) + EDR with SPP
Protocol for communication with optional printer
-20 dB SPL at 2 kHz (1 Hz bandwidth)
-13 dB SPL at 1 kHz (1 Hz bandwidth)
Length: 1.0 meter (40 in.)
Weight: 28 g (1.00 oz.)
HDMI
Page 47