General And Regulatory Information; Owner And Operator's Obligations; Manufacturer's Liability - Vatech EzRay Air VEX-P300 User Manual

General and Regulatory Information

1.
1.1

Manufacturer's Liability

The manufacturers and/or retailers of this equipment assume responsibility for the safe
and normal operation of this equipment only when:
▪ Always use genuine VATECH approved equipment and
▪ Perform all maintenance and repairs at a VATECH authorized
▪ Using this equipment properly according to the user manual.
▪ The equipment damage or malfunction is not the result of an error on the part of
the owner or operator.
1.2

Owner and Operator's Obligations

The owner of this equipment must perform constancy tests at regular intervals
▪
Eto ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.
▪ The owner of this equipment must perform regular inspection and maintenance of
the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1).
▪ The owner of this equipment must ensure inspection and cleaning work is
performed in accordance with the maintenance schedule outlined in Chapter 7
Cleaning and Maintenance.
DO NOT operate this equipment until reading this manual and reviewed
the related materials.
EzRay Air (Model: VEX-P300) User Manual
Disclaimer:
EzRay Air is sold with the understanding that the user assumes sole
responsibility for radiation safety (as well as any state, provincial, or
local regulatory compliance) and that VATECH, its agents or
representatives, do not accept responsibility for:
1) any injury or danger to personnel from X-ray exposure,
2) image over/underexposure due to poor operating techniques or
procedures,
3) equipment which has been damaged, modified, or tampered with
in any way.
1. General and Regulatory Information
parts.
distributor.
1