Myray ZEN-X - 1.4. Stylistic Conventions

EN
OPERATOR'S MANUAL
5
The sensor has been manufactured in compliance with the IEC standards on safety of electro-medical devices of
similar type and particularly with the following technical standards:
- IEC 60601-1:2005 + A1:2012 - General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 (4th Ed.) - General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-1-6:2010 + A1:2013 (3rd Ed.) - General requirements for safety - Collateral Standard: Usability
including IEC 62366: Application of usability engineering to medical devices.
- IEC 62304:2006 (1st Ed.) - Software life cycle processes.
- ANSI/AAMI ES60601-1: 2005 / A2:2010 - US NATIONAL DIFFERENCES Medical electrical equipment, Part 1:
General Requirements.
- CAN/CSA-C22.2 No. 60601-1:2008 - CA - CANADIAN NATIONAL DIFFERENCES to CAN/CSA-C22.2 No.
60601-1:2008.
The system is classified as Class II and Type B as far as safety is concerned, under IEC 60601-1.
1.4. STYLISTIC CONVENTIONS
The following symbols may be found on the device and in the manual:
Equipment compliant with directive 93/42/EEC as amended.
Notified body: IMQ S.p.A.
Applied part of type B, according to IEC 60601-1.
Product/equipment identification code.
Product serial number.
Manufacturer.
Date of manufacture (month / year).
It is necessary to read the user's manual before using the device.
Class II insulation.
Stand-by position, indicated on sensor support (only for the model integrated in dental unit).
Operating position, shown on the sensor support (only for the model integrated in dental unit).
Position for extraction of sensor support (only for the model integrated in dental unit).
Rest position, shown on the sensor support (only for the model integrated in dental unit).