Interacoustics Affinity 2.0 Gebrauchsanweisung Seite 10

1. Never insert, or in any way use, the insert headset without a new clean and non-def ective test tip.
Always make sure that the f oam or ear-tip is mounted correctly. Ear tips and f oam are f or single use
only.
2. The instrument is not intended f or use in environments exposed to f luid spills.
3. The instrument is not intended f or use in oxygen rich environments or f or use in conjunction with
f lammable agents.
4. Check calibration if any parts of the equipment are exposed to shock or rough handling.
5. Components marked f or "single use" are intended f or 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/of f f or the Af f inity2.0/Equinox2.0 device while a patient is connected.
7. The specif ications 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 "Af f inity2.0/Equinox2.0back panel". If the wrong socket is selected f or the transducer, the
stimulus sound pressure level (SPL) will not meet the calibrated level as set in the user interf ace and
this could lead to an incorrect diagnosis.
9. To ensure saf e operation and valid measurements, the Af f inity2.0/Equinox2.0 device and its
accessories must be checked and calibrated at least once a year or more f requently, if required by
local regulations or if there is any doubt about correct Af f inity2.0/Equinox2.0 device f unction.
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 inf ection control procedures between testing patients. Please ref er to cleaning
section
12. Ensure that the right/lef t transducer is connected to the corresponding ear of the patient and that the
correct test ear is selected f rom within the user interf ace.
13. To prevent electrical shock the equipment needs to be switched of f and disconnected f rom mains
when the enclosure is opened by service personnel.
NOTICE
1. To prevent system f aults, take appropriate precautions to avoid PC viruses and similar.
2. Using operating systems where Microsof t have discontinued sof tware and security support will
increase the risk f or viruses and malware, which may result in breakdowns, data loss and data thef t
and misuse.
Interacoustics A/S cannot be held liable f or your data. Some Interacoustics A/S products support or
may work with operating systems unsupported by Microsoft. Interacoustics A/S recommends you to
always use Microsof t supported operating systems that are kept f ully security updated.
3. Use only transducers calibrated with the actual instrument. To identif y a valid calibration, the serial
number f or the instrument will be marked on the transducer.
4. Although the instrument f ulf ils the relevant EMC requirements, precautions should be taken to avoid
unnecessary exposure to electromagnetic f ields, e.g. f rom 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 ref er to EMC considerations in section 11.7
5. Use of accessories, transducers, and cables other than specif ied, except f or 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 f ulf il the requirements please
ref er to section 1.3
6. Within the European Union, it is illegal to dispose of electric and electronic items in unsorted
Affinity2.0/Equinox2.0 – Instructions for Use - EN
municipal waste. Electric and electronic waste may contain hazardous
substances and theref ore must be collected separately. Such products
will be marked with the crossed-out wheeled bin symbol, shown below.
The cooperation of the user is important 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.
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