Asra Curve User Guide V9
27/05/2021
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1.
ASRA Curve Audiometer Important Safety Information
Read this Operating Manual before attempting to use the Instrument.
Warnings
This Instrument is for indoor use only and it should only be used as described in this manual.
The system must not be used in the presence of flammable gases or in an environment, which is
susceptible to explosions. (Beware of oxygen, dust, and anaesthetic gases)
This unit is powered by the mains adaptor supplied and is specified as part of the equipment. It is
advisable not to touch the patient while using the equipment.
The equipment should be positioned in such a way that it can be easily disconnected from the mains
supply. The operation of the system can be safely terminated by switching off or removing the mains
plug.
If your desktop PC or printer does not have a power supply approved for a patient environment,
then an isolation transformer, which is in compliance with BS EN 60601, should be used to power
the PC, printer, and the ASRA Curve. You must use the isolation transformer to ensure that the ASRA
Curve is in compliance with BS EN 60601.
Applied Parts. The Applied Parts are the headset and the response button.
CAUTIONS
Federal (USA) law restricts this device to sale by or on the order of a physician.
The use of the ASRA Curve near to sources of electromagnetic radiation, such as mobile phones,
radio transmitters, x-ray equipment etc, may prevent it from functioning correctly. Appendix 1
provides guidance on the Electromagnetic environment in which to operate the instrument.
This is a medical instrument, which has an electrical classification of Class 2 Type B and a Medical
Device Directive classification of Class IIa.
A Class II Type B device categorisation is used to describe an instrument which: -
a) Electrical equipment in which protection against electric shock does not rely
on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE
INSULATION or REINFORCED INSULATION are provided, there being no provision for protective
earthing or reliance upon installation conditions and
b) Applied parts offer protection to the subject against electrical shock and in the event of a single
fault condition arising, leakage current will be limited to less than 0.5 mA.
