10
D-0116492-B (OM022)
– Otosure Operating Manual
No parts of the equipment can be serviced or maintained while in use with the patient.
Connect only accessories purchased from Amplivox Ltd. to the Otosure. Only accessories which have been
stated by Amplivox Ltd. to be compatible are allowed to be connected to the device or cradle.
3.3.3.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the instrument
be operated within an ambient temperature range of 15 °C / 59 °F to 35 °C / 95 °F
and in relative humidity between 30 % and 90 % (non-condensing).
Do not use the device in the presence of fluid that can come into contact with any of the electronic components
or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician.
3.3.4.
ELECTRICAL AND ELECTROSTATIC SAFETY
Before performing any service to the insert earphones you must uncouple the
Otosure transducers 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 too high 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 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.
CAUTION
WARNING
CAUTION
Summary of Contents for Otosure
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