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18.1.3
The OTOsuite Immittance module
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.
18.2
Warning notes
18.2.1
MADSEN OTOflex 100 warning notes
MADSEN OTOflex 100 should only be provided with prescribed battery types. See Technical Specifications.
Place the batteries as indicated in the battery compartment, see
for further
details.
Use only rechargeable batteries when MADSEN OTOflex 100 is placed in the charger unit. If you are using
alkaline batteries, do not attempt to charge your MADSEN OTOflex 100. Your alkaline batteries may be
damaged and leak, and this may in turn cause damage to MADSEN OTOflex 100.
Batteries should be removed if equipment is not likely to be used for some time.
MADSEN OTOflex 100 should only be connected to charger type 1012 Charger from GN Otometrics A/S.
1. 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.
2. Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your
supplier for advice.
3. 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.
4. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Spe-
cifications, Transport and storage.
5. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
6. 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.
7. Unwanted noise may occur if the instrument is exposed to a strong radio field. Such noise may interfere with the pro-
cess of recording correct measurements. 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 this instrument be restricted as much as possible.
8. Unwanted interference may occur from other equipment, even if the equipment complies with CISPR emission
requirements.
Otometrics - MADSEN OTOflex 100
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18 Standards and safety