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Onyx may also be used by children over 11 years old, but only on
the approval of their optician. Children wearing the device must be
supervised at all times by a responsible adult.
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Onyx is compliant with IEC/EN 60601-1 with additional test
facilities for IEC/EN 61010 (Laboratory Equipment) including
Touch Leakage, Voltage Measurement and dedicated IEC 61010
Measuring Device (Body Model).
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Onyx is compliant with IEC 60601-1-2 which applies to the basic
safety and essential performance of Medical Electrical equipment
and Medical Electrical systems in the presence of electromagnetic
disturbances and to electromagnetic disturbances emitted by
Medical Electrical equipment and Medical Electrical systems.
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IEC 60601-1-2:2007, Clause 5.1.1
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Medical electrical equipment — Part 1-2: General
requirements for basic safety and essential performance
— Collateral standard: Electromagnetic compatibility —
Requirements and tests.
Summary of Contents for Onyx
Page 1: ...User Guide v2 5 O N Y X ...
Page 2: ......
Page 16: ...Page 14 Features Headset 1 Camera 2 Control buttons page 16 ...
Page 29: ...Page 27 ...
Page 59: ......
Page 60: ... OXSIGHT Ltd 2021 ...