
obtain the List Pair score. Results are compared to normative data to
obtain the SNR Loss.
Special Tests
MLB
(User Defined)
Lombard test
Pure Tone Stenger
Speech Stenger
SAL
Communications and
Talk Forward:
Permits the tester to speak through the test microphone into the
Monitoring
selected transducer at approximately the level set by the front panel
controls.
Talk Back:
Allows the tester to listen to comments from the patient in the testing
booth.
Monitor:
The monitor headset may be used by the tester to listen to Channel 1,
Channel 2, and/or Talk Back signals.
Environmental
Temperature:
+15ºC to 40ºC (59 to 104ºF)
Requirements
Relative Humidity:
10% to 95% (non-condensing)
Ambient Pressure Range:
98 kPa to 104 kPa
Background Sound Level:
<35 dB(A)
Storage Temperature:
0ºC to + 50ºC (32ºF to 122ºF)
Transport Temperature:
-20
º
C to + 50
º
C (-4
º
F to 122
º
F)
Quality System
Manufactured, designed, developed and marketed under ISO 13485 certified quality systems
Compliance/Regulatory
Designed, tested and manufactured to meet the following domestic (USA), Canadian, European and
Standards
International Standards:
ANSI S3.6, IEC 60645-1, IEC 60645-2, ISO 389
ES 60601-1 American Standards for Medical Electrical Equipment
IEC/EN 60601-1 International Standards for Medical Electrical Equipment
CSA C22.2 # 601-1-M90
Medical Device Directive (MDD) to comply with EC Directive 93/42/EEC
Notes: * Optional configuration
** The maximum HL values are applicable to the middle frequencies only
***RETSPL values interpolated