30
D-0116492-B (OM022)
– Otosure Operating Manual
9.
TECHNICAL SPECIFICATIONS
9.1.
STANDARDS AND REGULATORY
The Otosure Audiometer complies with the relevant parts of following standards:
•
BS/EN/IEC 60601-1: Medical Electrical Equipment
– General requirements for basic safety and
essential performance
•
BS/EN/IEC 60601-1-2: Medical Electrical Equipment
– Electromagnetic Compatibility: Requirements
and Tests
•
BS/EN/IEC 60645-1: Electroacoustics
– Audiological Equipment – Part1: Pure-tone Audiometers
Degree of protection against electric
shock:
Type B applied part
Degree of protection against ingress
of water:
Not protected
Mode of operation:
Continuous operation
Equipment mobility:
Portable
The Otosure audiometer is classified as a Class IIa device under Annex IX of the Medical Devices Directive.
It is intended for transient use as a screening hearing test instrument.
9.2.
INPUT/OUTPUT
Connection to PC:
USB (version 1.0 or 2.0); type B connector
Left and Right Outputs:
6.3mm Jack Socket
Patient Response Switch:
6.3mm Jack Socket
Maximum voltage at any output:
5V peak
9.3.
AUDIOMETRIC
Audiometer type:
Type 4 (IEC 60645-1:2001 & ANSI S3.6:2004)
Frequencies:
125Hz, 250Hz, 500Hz, 1kHz, 1.5kHz, 2kHz, 3kHz, 4kHz, 6kHz, 8kHz
Frequency accuracy:
<1%
Distortion:
<2%
Output level range:
-10dB to 100dBHL (80dBHL at 125Hz)
Output level steps:
5dB
Output level accuracy:
Within 3dB
Headset static force:
4.5N
9.4.
EARPHONE SOUND ATTENUATION CHARACTERISTICS
Frequency, Hz
125
250
500
1000
2000
4000
8000
Attenuation, dB
2
5
7
15
25
31
23
9.5.
PHYSICAL & ENVIRONMENTAL
Audiometer Dimensions:
120mm (L) x 85mm (W) x 30mm (H)
Audiometer Weight:
150gm
Operating temperature:
+15
o
C to +35
o
C
Storage/transport temperature:
-20
o
C to +70
o
C
Humidity (operating):
30% to 90% (non-condensing)
Summary of Contents for Otosure
Page 1: ...Otosure Operating Manual...
