sanowell Life TENS, Instructional Manual

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10.3. Safety-technical control measures, STC
According to the medical products operator’s regulation (MPBetreibV), § 6 (safety-
technical control measures), the user is obliged to have regular safety-technical
controls conducted. hofmann gmbh prescribes these controls in accordance to
MPBetreibV § 6 in a 24-months turn.
The safety-technical control may only be delegated to persons, who are able to
conduct controls in an orderly fashion based on their education, knowledge, and
experience achieved by practical work, and who also have suitable measuring and
proofing tools available.
Standards for safety-technical control are to be requested from the quality manage-
ment agent of hofmann gmbh.
Prior to each application of the sanowell Life Tens device the following controls are
to be conducted:
1. Inspect device for surface damage:
• Deformation of casing?
• Damaged or defect electrode sockets?
2. Inspect device for damaged control elements:
• Imprints still legible?
3. Inspect display elements:
• When the corresponding chanel is working the related LED needs to be illumina-
ted.
4. Inspect accessories for usability:
• Electrode wires non-damaged?
• Electrodes non-damaged (no fissures, no worn material)?
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