Aoralscan 3_Manual_V1.0.0.30 - 12 -
basic safety and essential performance-Collateral Standard: Electromagnetic disturbances–
Requirements and tests
⚫ IEC 60601-1: 2015/A1: 2012 (ed 3.1) Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
⚫ IEC 60601-1-6: 2013.Con Ed 3.1 Rev. October 29. 2013. Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance – Collateral standard:
Usability
⚫ IEC 62366-1: 2015 Medical devices–Part 1: Application of usability engineering to
medical devices
2.5.2. Classification
⚫ Type of protection against electric shock: Class II
⚫ The degree of protection against electric shock: Type BF
⚫ Enclosure protection: IPX0
⚫ Degree of protection against incoming liquids: Common device.
⚫ Level of safety when used with flammable anesthetic gas mixed with air or flammable
anesthetic gas mixed with oxygen or nitrous oxide: Non-AP/APG equipment.
⚫ The mode of operation: Continuous operation
⚫ Pollution degree 2
WARNINGS
⚫ Shock hazards exist if the power adapter is damaged or is not properly grounded. Use
only the supplied medical grade power adapter.
⚫ To meet waterproof requirements, the sockets should not be placed on the ground.
⚫ Do not use grounding type plugs for other purposes.
⚫ Only authorized service labs can make internal replacements of the scanner and modify
the software.
⚫ Do not use the scanner if its head or cable is damaged. Contact technical support for
replacement of the damaged equipment (see Contact information on chapter 1).
⚫ To avoid risk of electrical shock hazards, always inspect the scanner and cable
connections before use.
⚫ Check the cable housing before use. Do not use the scanner if the housing is damaged
or the cable is abraded.
⚫ All devices connected to the Aoralscan 3 shall comply with IEC 60601-1 and IEC 60950.
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