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.
14.2
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.
8. We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as
this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.
9. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Spe-
cifications, Transport and storage.
10. Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the
instrument and it may result in a risk of electrical shock to the user or patient.
11. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
12. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use
section of this manual.
13. Choking hazard! Do not leave eartips unsupervised within the reach of children.
14. The device and any device to be connected which has its own power supply should be turned off before any con-
nections are established.
To disconnect the device from the mains supply, pull the mains plug out of the wall mains
outlet. Do not position the unit so that it is difficult to pull the mains plug out of the wall mains.
15. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
Otometrics - MADSEN Zodiac
User Guide
38
