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SCHWIND Amaris 500E - Technical Security Check (TSC)

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USER MANUAL (Instruction for Use) SW 6.1
Maintenance
Version 6.1.6 dated 2020-01-31 EN Page 183 of 201
10.5 Changing of the ArF Premix Gas Bottle or Helium Gas Bottle
Changing of gas bottles is only allowed to be carried out by service technicians authorized by
SCHWIND eye-tech-solutions.
After the replacement of every two premix gas bottles, the halogen filter (scrubber) has to be
replaced also.
IMPORTANT NOTE
Used halogen filters have to be disposed in a professional way as special
refuse.
10.6 Technical Security Check (TSC)
In order to ensure the error-free functioning of the excimer of laser, please ensure that an annual
technical security check (TSC) is performed.
The Service Representatives of SCHWIND eye-tech-solutions or service technicians specifically
authorized by SCHWIND eye-tech-solutions will carry out a technical safety inspections (TSC) in
yearly intervals and document it in the Medical Device Logbook (Medical Apparatus Book).
When the TSC comes due, it will be indicated by the software. Additionally, the date for the next
TSC is displayed on a label applied to the Panel PC.
Please contact SCHWIND eye-tech-solutions in order to coordinate the inspection date.
The safety inspections contain the exchange of components, wearing parts, disposable articles
and the device interfaces used in connection with the deployment of the device whenever the
safety of system use can be significantly influenced by these secondary components.
IMPORTANT NOTE
If inadequacies are found during the technical inspection, which can affect
the safety of patients, users or third parties, the device may not be used until
the deficiencies have been eliminated.
The service technicians will complete the test protocol during the corresponding service intervals
of the entire system.

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