Environmental Factors; Electrical And Electrostatic Safety; Electromagnetic Compatibility (Emc); Explosion Hazards - Interacoustics Sera Instructions For Use Manual

Environmental factors

Do not use the device in the presence of fluid that can come into contact with any of the electronic
components or wiring. Should the user suspect fluids have contacted the system components or
accessories, the unit should not be used until deemed safe by an authorized service technician.

Electrical and electrostatic safety

Electromagnetic compatibility (EMC)

Explosion hazards

D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
Use and store the instrument indoors only. It is recommended to operate the
instrument within an ambient temperature range of 5 °C / 41 °F to 40 °C / 104 °F
and in a relative humidity between 15 % and 93 % (non-condensing).
For transport and storage conditions, please refer to section 6.
Before performing any service to the insert earphones, you must uncouple the
Sera transducers and electrodes from the patient.
TM
Do not touch the contacts on the bottom of the instrument and the patient at
the same time. The consequence could be a too high leakage current to the
patient.
Do not open the case of the instrument. Refer servicing to qualified personnel.
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 observed 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 near
flammable anesthetic gases.
Do NOT use the Sera
hyperbaric chamber, oxygen tent, etc.
in a highly oxygen-enriched environment, such as a
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