TECHNICAL DOCUMENTATION
SERVICING INFORMATION
TECH 01.0 – 800.16
Page 2 of 4
Guidance documents
The following guidance documents will be referenced as part of the servicing activities:
• 992015 – QA3 Powered Function Stretchers Instruction for Use.
• Medicines & Healthcare products Regulatory Agency: Managing Medical Devices Guidance for
health and social care organisations.
• BS EN 62353 2014 - Medical electrical equipment — Recurrent test and test after repair of
medical electrical equipment
Calibration
A QA3™ Ophthalmic Stretcher variant does not require calibration to an accredited national standard.
Qualification of personnel
In line with the MHRA document, Managing Medical Devices, servicing should only be conducted by
suitably trained personnel following manufacturer’s guidelines.
Documented procedures
Following documented procedures as part of servicing activities is recommended.
Records
Records of servicing activities will be maintained to provide evidence of conformity and of effectiveness.
Records will remain legible, readily identifiable and retrievable. Changes to records shall remain
identifiable.
Records will be maintained for at least the lifetime of the device.
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