Tremetrics RA660, Operation Manual

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RA660 Operation Manual
8509790 Rev. 2 55 18/04/2018
6 Technical Specifications
6.1 Technical Data
The touchTymp is an active, diagnostic medical product
according to the class IIa of the EU medical directive
93/42/EEC.
ITEM SPECIFICATION
Standards:

ANSI S3.6-2010: Type 4

IEC 60645-1 : Type 4

ISO 389

ES 60601-1 class I protection, class B applied parts,
American Standards for Medical Electrical Equipment

IEC 60601-1 class I protection, class B applied parts,
International Standards for Medical Electrical
Equipment

IEC 60601-1-2, Electromagnetic compatibility
–
Requirements and tests

CSA C22.2 # 60601-1-08

Medical Device Directive (MDD) to comply with “EC
Directive” 93/42/EEC
Test Frequencies:

250 Hz
– 8000 Hz
Maximum Test Levels:

100 dB
HL
250 Hz
– 8000 Hz

90 dB
HL
IP 30 6 kHz & 8 kHz
Headset

AC with Earphone TDH-39P or DD45
Insert Earphones

RADIOEAR IP 30
Attenuator Range:

-10 to 100 dB
HL
in 5 dB
HL
Steps
Test Signal:

Pure tone
Modulation:

Pulse Tone 200 mS on 200 mS off
Subject Response:

Handheld response switch
Response Window:

1.8 s from presentation of tone
Communication:

Talk over
Data Connection:

USB
Stimulus Functions:

Tone Presenter
Bio-acoustic Simulator

Response at 65 dBHL +/- 10 dB at 250 to 8000 Hz
Room Monitor

Octave band measurements 125 to 8000 Hz
Warm-up Time:

Less than 10 min after power on
Mode of Operation:

Continuous
Environment Conditions: Operation +15 °C
… +35 °C / +59 °F … +95 °F
Humidity: 30 %
… 90 %, non-
condensing
Air pressure: 80 kPa ... 104 kPa