Interacoustics Affinity 2.0 Manual De Instrucciones página 10

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 Affinity 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 "Affinity 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 Affinity 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 Affinity 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.
13. To prevent electrical shock the equipment needs to be switched off and disconnected from mains
when the enclosure is opened by service personnel.
NOTICE
1. To prevent system faults take appropriate precautions to avoid PC viruses and similar.
2. Using operating systems where Microsoft have discontinued software and security support will
increase the risk for viruses and malware, which may result in breakdowns, data loss and data theft
and misuse.
Interacoustics A/S cannot be held liable for 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 Microsoft supported operating systems that are kept fully security updated.
3. 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.
4. 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
5. 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
6. Within the European Union, it is illegal to dispose of electric and electronic items in unsorted
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.
Affinity2.0 – Instructions for Use - EN
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
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