Interacoustics Equinox2.0 Gebrauchsanweisung Seite 10

Affinity Instructions for Use - EN
5. If this apparatus is connected to one or more other devices with medical CE marking, to make up a
system or pack, the CE marking is only valid also for the combination if the supplier has issued a
declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the
combination.
6. If connection is made to standard equipment like an active speaker, special precautions must be
taken in order to maintain medical safety. If used without galvanic separation, it must be supplied
from a medical isolation transformer fulfilling the requirements of IEC/ES 60601-1.
7. Do not disassemble or modify the product as this may impact the safety and/or performance of the
device.
NOTICE
1. DO NOT connect the Affinity2.0 hardware to the computer before the software has been installed!
2. The instrument is intended for continued use. However, there is a risk of damaging the transducers if
they are operated at the highest intensities for longer periods.
3. To avoid overheating, please observe that cooling vents are unobstructed and that the air can flow
freely around the instrument.
4. 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 have to be disposed of
separately. Such products will be marked with the crossed-out wheelie-bin
image shown to the left. User cooperation is important in order 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.
No installation precautions are necessary to avoid unwanted sound radiation from the audiometer.
When connecting the Affinity2.0 to the mains supply and to a computer the following warnings must be
observed:
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