UNPACKING AND INSTALLATION
11
OTOWAVE 302+ INSTRUCTION FOR USE
2.3.4.
ELECTRICAL AND ELECTROSTATIC SAFETY
Before performing any service to the contra earphone or probe, you must remove them
from the patient.
Do not touch the contacts on the back of the instrument and the patient at the same
time. The consequence could be a leakage current to the patient.
Do not open the case of the instrument. Refer servicing to qualified personnel.
This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External
equipment intended for connection to signal input, signal output or other connectors must comply with the relevant
product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In
addition, all such combinations
–
Medical Electrical Systems
–
must comply with the safety requirements stated in the
general standard IEC 60601-1, (edition 3.1), clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 must be kept outside the patient environment i.e. at least 1.5m from the patient support
or must be supplied via a separation transformer to reduce the leakage currents. Any person who connects external
equipment to signal input, signal output or other 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 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 the Amplivox Mains Power Adaptor.
2.3.5.
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.
2.3.6.
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 Otowave 302+ in a highly oxygen-enriched environment, such as a
hyperbaric chamber, oxygen tent, etc.
2.3.7.
MEASURING ACCURACY
CAUTION
WARNING
CAUTION
WARNING
