Environmental Factors - Interacoustics OtoRead Instructions For Use Manual

OtoRead™ Instructions for Use - US
No parts of the equipment can be serviced or maintained while in use with the patient.
Connect only accessories purchased from Interacoustics to the OtoRead
been stated by Interacoustics to be compatible are allowed to be connected to the device or cradle.
WARNING
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 shall comply
with the relevant product standard e.g. IEC 60950-1 for IT equipment (ITE) and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations – Medical Electrical Systems – shall comply
with the safety requirements stated the general standard IEC 60601-1, edition 3, clause 16. Any equipment
not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient
environment i.e. at least 1.5 m from the patient support or shall be supplied via a separation device 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 the requirements. If in doubt, contact a qualified medical technician or your local representative. If the
instrument is connect to a PC (IT equipment forming a system) do not to touch the patient while operating
the PC.
If the instrument is connected to a PC (IT equipment forming a system), assembly and modifications shall be
evaluated by a qualified medical technician according to safety regulations in IEC 60601.
Please note: The USB connection on the instrument has an insulation protection on the cable. To prevent
potential leakage of electrical current to the patient, it is recommended that only the cable supplied is used.
The instrument is not protected against harmful ingress of water or other liquids. If any spillage occurs check
the instrument carefully before use or return for service.
No part of the equipment can be serviced or maintained while in use with the patient.
This instrument contains a lithium battery. The battery can only be changed by service personnel. Batteries
may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures. Do not short-
circuit. Please also refer to section 2.6.2.2.

Environmental factors

CAUTION
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 been in contact with the system components or
accessories, the unit should not be used until deemed safe by an authorized service technician.
Use and store the instrument indoors only. It is recommended that the
instrument be operated within an ambient temperature range of 0 °C / -32 °F to
50 °C / 122 °F and in relative humidity of between 30 % and 90 % (non-
condensing).
Transport and store the instrument in temperatures between -20 °C / -4 °F 1 to
+50 °C / +122 °F and in relative humidity of between 10 % and 95 % (non-
condensing).
TM
. Only accessories which have
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