Asra Curve User Guide V9
27/05/2021
Page
6
of
40
Any incident, which results in actual or potential injury or death to a subject while using the ASRA
Curve should be immediately communicated to GM Instruments at the address below.
The ASRA Curve should only be connected to other mains powered devices such as computers and
printers, which comply with EN 60950-1 and we also advise the use of a separating transformer.
Unless computers and printers built to EN 60950 are used, patient safety might be compromised.
Non-medical equipment such as computers and printers should be kept out of reach of subjects
being tested as such equipment does not comply with medical safety standards. Refer to clause 16
of EN 60601-1:2006 to ensure compliance.
If the PC is allowed to go in to sleep mode, the USB interface is powered down. When brought out of
sleep mode, the PC does not re-initialise the USB interface, and it is effectively not present. A solution is
to remove the USB connection at the PC or instrument side then reconnect. That may be sufficient, but
if not, save any results, close down the instrument software, and restart it
Servicing can only be carried out by GMI approved and authorised
personnel. No modifications are allowed
.
2.
Technical Specification
Factory-trained personnel or engineers familiar with the standard EN 60601 can only undertake
servicing of the ASRA Curve Audiometer. Circuit diagrams will be made available to competent
persons on request.
Medical CE
Mark
The CE mark indicates that the device meets the requirement of Annex V & VII of
the Medical Device Directive 94/42/EEC. Approval of the Quality System is made
by BSi whose notified body number is 2797
Standards
Safety
BS EN 60601-1 Class 2 Type B applied parts
EMC
BS EN 60601-1-2
Audiometer
BS EN 60645 -1, Type 4
Categorisation
UK & Ireland H&SE
Operation
Environment
Temperature
15°C to 35°C
Relative Humidity
30% to 90%
Ambient Pressure
98kPa to 104kPa
Warm up time
5 Minutes
Transport &
Storage
Storage
&Transport
Temperature
-40°C to +60°C
Relative Humidity
30% to 90%
Supply Power
Supplied PSU
Use only specified PSU
VEP15US09 *
Line Voltage
100V to 240 V at 50-60 Hz
Consumption
12.6W
Tone Type
Tone switching
-Tone Presentation
-Tone Interruption
Automatic Mode
