Interacoustics Eclipse ABRIS, Instructions For Use Manual, Page: 14 / 149

D-0120588-B
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2019/03
Eclipse
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Instructions for Use - EN Page 6
1. Never insert, or in any way use, the insert headset without a new clean and non-defective test tip.
Always make sure that the foam or ear-tip is mounted correctly. Ear tips and foam are for single use
only.
2. The instrument is not intended for use in environments exposed to fluid spills.
3. The instrument is not intended for use in oxygen rich environments or for use in conjunction with
flammable agents.
4. Check calibration if any parts of the equipment are exposed to shock or rough handling.
5.
Components marked for “single use” are intended
for a single patient during a single procedure, and
there is a risk of contamination if the component is re-used.
6. Do not switch the power on/off for the Eclipse device while a patient is connected.
7. The specifications for the device are valid if the device is operated within the environmental limits.
8. When connecting the device to its accessories, use only the dedicated socket as described in the
section “
Eclipse back panel
”. If the wrong socket is selected for the transducer, the stimulus sound
pressure level (SPL) will not meet the calibrated level as set in the user interface and this could lead to
an incorrect diagnosis.
9. To ensure safe operation and valid measurements, the Eclipse device and its accessories must be
checked and calibrated at least once a year or more frequently, if required by local regulations or if
there is any doubt about correct Eclipse device function.
10. Use only sound stimulation intensities that will be acceptable to the patient.
11. It is recommended that parts which are in direct contact with the patient (e.g. the probe) are subjected
to standard infection control procedures between testing patients. Please refer to cleaning section
12. Ensure that the right/left transducer is connected to the corresponding ear of the patient and that the
correct test ear is selected from within the user interface.
NOTICE
1. To prevent system faults take appropriate precautions to avoid PC viruses and similar.
2. Use only transducers calibrated with the actual instrument. To identify a valid calibration, the serial
number for the instrument will be marked on the transducer.
3. 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 monitored to ensure that there is no mutual disturbance.
Please also refer to EMC considerations in section 11.7
4. Use of accessories, transducers and cables other than specified, with the exception of transducers
and cables sold by Interacoustics or representatives, may result in increased emission or decreased
immunity of the equipment. For a list of accessories, transducers and cables that fulfil the
requirements please refer to section 1.3
5. Within the European Union, it is illegal to dispose of electric and electronic items in unsorted municipal
waste. Electric and electronic waste may contain hazardous substances and therefore has to be
collected separately. Such products will be marked with the crossed-out wheeled bin symbol,
shown below. The cooperation of the user is important in order to ensure a high level of
reuse and recycling of electric and electronic waste. Failing to recycle such waste products in
an appropriate way may endanger the environment and consequently the health of human
beings.
6. Outside the European Union, local regulations should be followed when disposing of the product after
end of life.
7. The LBK15 unit is not valid for performing a functional check of ASSR and ABRIS due to the nature of
ASSR algorithms. For functional testing (detection of false passes), a patient must be connected with
electrodes, in the absence of a stimulus (disconnected transducer).