Standards And Regulations - Vatech EzRay Premium VEX-S100W User Manual

1. General and Regulatory Information
Symbols
1.5

Standards and Regulations

Standards:
The EzRay Premium is designed and manufactured to meet the following standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3,
IEC/EN 60601-2-7, IEC/EN 60601-2-28, IEC/EN 60601-2-32,
ISO 9001, ISO 13485
4
Description
This symbol indicates that electrical and
electronic equipment must not be disposed
of as unsorted municipal waste and must be
collected separately.
ESD susceptibility symbols indicate that an
item is susceptible to damage from
electrostatic discharges.
This symbol indicates that this equipment is
classified as a CLASS 1 LASER PRODUCT
in accordance with IEC 60825-1 ED.1
regulations.
Date of manufacture
Refer to the Instruction manual
Caution:
Federal law restricts this device to sale by or
on the order of a licensed healthcare
practitioner.
Indicates the manufacturer's serial number
so that the specific equipment can be
identified.
The CE symbol grants this equipment complies with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
Location
Label
Board
package
Label
Label
Label
Label
Label
EzRay Premium User Manual