3. 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.
4. It is recommended to install the unit in an environment that minimizes the amount of environmental noise.
5. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example,
anti-static carpeting is recommended.
6. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Spe-
cifications, Transport and storage.
7. 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.
8. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
9. 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.
10. The device should be turned off before any connections are established.
To disconnect the device from the power
supply, pull the USB plug out of the PC, or shut down the PC.
11. We recommend that an annual calibration be performed on accessories containing microphones. Furthermore, we
recommend that calibration be performed if the equipment has suffered any potential damage (e.g. microphone
dropped on the floor). Note that calibration has been performed only on the microphones supplied! If you wish to use
other microphones for testing with the device, please contact your local distributor first.
12. To prevent cross-infection, use fresh acoustic putty when you test the next hearing instrument.
13. 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.
14. Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the process
of testing or fitting a hearing instrument. 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 the device is restricted as much as possible. Like-
wise, we recommend that the device is not used in the vicinity of devices sensitive to electromagnetic fields.
15. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
16. The device can be disposed of as normal electronic waste, according to local regulations.
17. Use only the power supply specified in Technical Specifications,
When assembling a system, the person carrying out the assembly must take into account that other con-
nected equipment which does not comply with the same safety requirements as this product (e.g. PC
and/or printer) may lead to a reduction in the overall safety level of the system. The equipment must com-
ply with IEC 60950.
7.3
The OTOsuite HIT Module
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
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Otometrics - AURICAL HIT
7 Standards and Safety
