Madsen Zodiac User Manual page 51

OTOsuite Immittance 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.
15.2 Warning notes
This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.
1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care pro-
fessional.
2. MADSEN Zodiac is intended for diagnostic and clinical use by audiologists and other trained health care professionals
in testing the hearing of their patients.
3. If you suspect infection in one ear, exchange the eartip and use a clean probe tip before you continue testing on the
other ear.
4. To prevent cross-infection, use new eartips when you test the next client.
5. Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your
supplier for advice.
6. For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should
be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any
defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.
7. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example,
anti-static carpeting is recommended.
Otometrics - MADSEN Zodiac
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.
OR
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1
(2014) and CAN/CSA-C22.2 No. 60601-1-6 (2011).
In France, it is only permitted to use the device indoors.
This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:
• This device must not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired
operation.
The term"IC" before the certification/registration number signifies that the Industry Canada technical spe-
cifications were met.
User Guide
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