D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN
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2.7 Use in home healthcare environment
The instrument is suited for use in home healthcare environments when protected with the enclosed carrying
case during transport
2.8 Measuring security and clinical benefit
To guarantee that the Sera
TM
works properly, the instrument should be checked and calibrated at least once
a year.
The service and calibration must be performed by an authorized service technician. If these checks are not
performed, Medical Device 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. Incorrect test results
can lead to inappropriate treatment of patients.
2.9 Miscellaneous
Please note:
DO NOT connect the Sera
TM
hardware to the computer before the software has been installed!
Storage in temperatures below 0
°
C /32
°
F and above 50
°
C /122
°
F may cause permanent damage to the
instrument and its accessories.
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 must be disposed of separately. Such products will be marked
with the crossed-out wheelie-bin image shown to the left. User cooperation is important 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 end
of life.
2.10 Use of equipment after transport and storage
Please make sure that the instrument is functioning correctly before use. If the instrument has been stored in
a cold environment (even for short period of time), please allow the instrument to become acclimatized. This
can take a long time depending on the conditions (such as environmental humidity). You can reduce the
condensation by storing the instrument in its original packaging. If the instrument is stored under warmer
conditions than the actual use conditions no special precaution is required before use. Always ensure proper
operation of the instrument by following routine check procedures for audiometric equipment
