Marking; General Warnings And Precautions - Interacoustics AD226 Instructions For Use Manual

AD226 Instruction for Use - EN

2.2 Marking

The following marking can be found on the instrument:
Symbol
0123
Type plate is located beneath the instrument

2.3 General Warnings and Precautions

External equipment intended for connection to signal input, signal output or other connectors shall comply
with relevant IEC standard (e.g. IEC 60950 for IT equipment). In these situations an optical isolator is
recommended to fulfill the requirements. Equipment not complying with IEC 60601-1 shall be kept outside
the patient environment, as defined in the standard (usually 1.5 meter). If in doubt, contact qualified medical
technician or your local representative.
This instrument does not incorporate any separation devices at connections for PC's, printers, active
speakers etc. (Medical Electrical System)
When the instrument is connected to a PC and other items of equipment of a medical electrical system
assure that the total leakage current cannot exceed the safety limits and that separations have the dielectric
strength, creepage clearances and air clearances required fulfilling the requirements of IEC/ES 60601-1.
When the instrument is connected to a PC and other similar items be aware of not touching the PC and
patient simultaneously
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
Refer to instruction manual
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product,
it must be sent to separate collection facilities for recovery and recycling.
Failing to do so may endanger the environment.
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive
93/42/EEC. TÜV Product Service, Identification No. 0123,
has approved the quality system.
Year of manufacture
Do not re-use
Parts like ear-tips and similar are for single use only
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