11
D-0116493-B (OM015)
– PC850 Operating Manual
connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with
these requirements. If in doubt, contact a qualified medical technician or your local representative. When the
instrument is connected to a PC, or other similar items, beware of not touching the PC and patient
simultaneously.
A Separation Device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a Separation Device
is required when a network connection is made. The requirement for the Separation Device is defined in IEC
60601-1 clause 16.
Do not use any additional multiple socket-outlet or extension cord.
Use only UES12LCP Power Supply.
3.3.5.
ELECTROMAGNETIC COMPATIBILITY (EMC)
Although the instrument fulfills 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 observed that no mutual disturbance appears. Please also refer to the
appendix regarding EMC.
3.3.6.
EXPLOSION HAZARDS
Risk of explosion.
Do not use in the presence of flammable anesthetics or other gases.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the PC850 in a highly oxygen-enriched environment, such as a
hyperbaric chamber, oxygen tent, etc.
3.3.7.
MEASURING SECURITY
To guarantee that the PC850 works properly, the instrument should be checked and calibrated at least once
a year. The transducers supplied with the audiometer are specifically calibrated with it; if these transducers
are changed recalibration will be required.
The service and calibration must be performed by an authorized service technician. If these checks are not
performed, EU Medical Device Directive (MDD) and other regulations may be violated and warranties may be
void.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.
3.3.8.
MISCELLANEOUS
Please note:
DO NOT connect the PC850 hardware to the computer before the software has been installed!
Storage in temperatures below 0
C /32
F and above 50
C /122
F may cause permanent damage to the
instrument and its accessories.
Do not place the instrument next to a heat source of any kind.
CAUTION
WARNING
Содержание PC850
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