4. Do not immerse the unit in any fluids. See the operation manual for proper cleaning
procedures.
5. Do not drop or otherwise cause undue impact to this device. If the instrument is dropped or
otherwise damaged, return it to the manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
6. Use and store the instrument indoors only. Do not use this instrument or its accessories in
temperatures below 4°C /40°F or above 38°C /100°F, or in relative humidity of more than
90%.
7. Do not attempt to open or service the instrument. Return the instrument to the manufacturer
for all service. Opening the instrument case will void the warranty.
8. Do not operate the printer if the power supply has a damaged cord or plug. See the
instructions below.
9. Be sure to use only stimulation intensities, which will be acceptable for the patient.
10. The transducers (headphones, bone conductor, etc.) supplied with the instrument are
calibrated to this instrument - exchange of transducers require a recalibration.
11. Please note that the CE Marking is only legal if this Instruction is translated into the national
language of the user no later than at the delivery to him, if the national legislation demands a
text in the national language according to MDD article 4.4.
12. Although the instrument fulfils the relevant EMC requirements precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the
device is used adjacent to other equipment it must be observed that no mutual disturbance
appears.
13. Disposal of batteries must be made according to national regulations.
OtoRead™ – Instructions for Use - EN
If this apparatus is connected to one or more other devices with medical CE
marking, to make up a system or pack, the CE marking is only valid also for
the combination if the supplier has issued a declaration stating that the
requirements in the Medical Device Directive article 12 are fulfilled for the
combination.
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