otometrics AURICAL Aud, Reference Manual

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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.
12.3 The OTOsuite Audiometry Module
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
Used in error message dialogs if software program fails. See the detailed information in the dialog box.
12.4 Manufacturer
GN Otometrics A/S
Hoerskaetten 9, 2630 Taastrup
Denmark
(
+45 45 75 55 55
7
+45 45 75 55 59
www.otometrics.com
12.4.1 Responsibility of the manufacturer
The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:
• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man-
ufacturer or personnel authorized by the manufacturer.
• The electrical installation to which the equipment is connected complies with EN/IEC requirements.
• The equipment is used in accordance with the instructions for use.
The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of
equipment serviced or repaired by other parties.
118 Otometrics - AURICAL Aud
12 Standards and Safety