Interacoustics Equinox2.0 Gebrauchsanweisung Seite 10

Affinity Instructions for Use - EN
Device is required when a network connection is made. The requirement for the Separation Device is
defined in IEC 60601-1 clause 16.
3. To avoid the risk of electric shock, this equipment must only be connected to supply mains with a
protective earth.
4. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to section
2.3
5. No modification of this equipment is allowed without the authorization of Interacoustics.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information. This will assist service personnel to repair, the parts of this
audiometer that are designated by the Interacoustics service personnel as repairable.
6. For maximum electrical safety, turn off the power to a mains- powered instrument when it is left unused.
7. The instrument is not protected against ingress of water or other liquids. If any spillage occurs, check the
instrument carefully before use or return for service.
8. No part of the equipment can be serviced or maintained while in use with the patient.
9. Do not use the equipment if it is showing visible signs of damage.
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. Toprevent electrical shock the equipment needs to be switched off and disconnected from mains
when the enclosure is opened by service personnel.
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