Electrical And Electrostatic Safety; Electromagnetic Compatibility (Emc); Explosion Hazards; Measuring Security - Interacoustics OtoRead Instructions For Use Manual

OtoRead™ Instructions for Use - US

Electrical and electrostatic safety

CAUTION

Electromagnetic compatibility (EMC)

CAUTION

Explosion hazards

WARNING

Measuring security

To guarantee that the OtoRead
once per year.
The service and calibration must be performed by an authorized service technician. If these checks are not
done, EU Medical Device Directive (MDD) and other regulations may be violated and warranties may be
void.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.

Miscellaneous

Please note:
DO NOT connect the OtoRead
Do not place the instrument next to a heat source of any kind.
Great care should be exercised when handling transducers, as rough handling, for example dropping
onto a hard surface, may break or damage the parts.
Within the European Union it is illegal to dispose of electrical and electronic waste as
unsorted municipal waste. Electrical and electronic waste may contain hazardous
substances and therefore have to be disposed of separately. Such products will be marked
with the crossed-out wheelie-bin image shown to the left. User cooperation is important in
order to ensure a high level of reuse and recycling of electrical and electronic waste. Failure
to recycle such waste products in an appropriate way may endanger the environment and
consequently the health of human beings.
Outside the European Union, local regulations should be followed when disposing of the product after its
useful life.
Before performing any service to the insert earphones you must detach
TM
the OtoRead transducers from the patient.
Although the instrument fulfills 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 checked that no mutual disturbance appears. Please also refer to the
appendix regarding EMC.
Risk of explosion.
Do not use in the presence of flammable anesthetics or other gases.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the OtoRead
a hyperbaric chamber, oxygen tent, etc.
TM
works properly, the instrument should be checked and calibrated at least
TM
hardware to the computer before the software has been installed!
TM in a highly oxygen-enriched environment, such as
Page 9