Markings; General Warnings And Precautions - Interacoustics EyeSeeCam vHIT Manual De Instrucciones

EyeSeeCam vHIT Instructions for Use - EN
2.2

Markings

The following markings can be found on the instrument:
Symbol
0123

2.3 General warnings and precautions

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 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
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 the requirements. If in doubt, contact qualified medical technician or your local
representative.
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, edition 3, clause 16.
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
Follow instructions for use
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.
This product is laser class 1. This means the maximum permissible
exposure (MPE) cannot be exceeded when viewing a laser with the naked
eye.
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