17. Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the per-
formance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We
recommend that the use of such devices in the vicinity of AURICAL Aud be restricted.
Likewise, we recommend that the instrument is not used in the vicinity of devices sensitive to electromagnetic fields.
18. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
19. The device can be disposed of as normal electronic waste, according to local regulations.
20. Use only the specified power supply.
See the Technical Specifications, Power Supply.
When assembling an electro-medical system, the person carrying out the assembly must take into account
that other connected equipment which does not comply with the same safety and EMC requirements as this
product (e.g., cables, PC and/or printer) may lead to a reduction in the overall safety level or EMC compliance
level of the system. The equipment must comply with IEC 60950.
When selecting accessories connected to the device, the following points must be considered:
• Use of connected equipment in a patient environment
• Proof that connected equipment has been tested in accordance with IEC60601-1 and/or IEC60601-1-1
and UL60601-1 and CAN/CSA-C22.2 NO 601.1-90.
21. To comply with EN 60601-1-1 computer and printer must be placed out of reach of the client, i.e. not closer than
approx. 1.5 meters/5 ft.
22. The charger unit should be kept away from the client area.
23. There are no user-serviceable parts inside the charger unit cabinet. For the sake of safety, and in order not to void the
warranty, the cabinet should only be opened and serviced by authorized service personnel. In case of defects, please
make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument.
24. The charger unit can be disposed of as normal electronic waste, according to local regulations.
20 Manufacturer
GNOtometricsA/S
Hoerskaetten 9, 2630 Taastrup
Denmark
( +45 45 75 55 55
7 +45 45 75 55 59
www.otometrics.com
20.1 Responsibility of the manufacturer
The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:
Otometrics - AURICAL Aud
37
20 Manufacturer
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