schwa-medico TENStem eco basic - Classification; Reporting Obligation; Warranty; Care and Cleaning

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6.6 Classication
The TENStem eco basic is classied as class IIa according to Annex IX of Directive 93/42/
EEC or according to Annex VIII of the Medical Devices Regulation (EU) 2017/745 on medical
devices.
6.7 Reporting obligation
Any serious incident occurring in connection with this device is to be reported to the man-
ufacturer and to the competent authority of the Member State in which the user and/or
patient is established.
6.8 Warranty
The manufacturer grants a warranty of twelve months on the TENStem eco basic device
from the date of acceptance by the end customer.
The guarantee does not apply:
• to wear parts and consumables such as electrodes, batteries and connection cables
• in the event of damage resulting from improper operation
• for defects that were already known to the customer
• in the event of the customer's own fault
6.9 Care and cleaning
No special care or cleaning products are required for the TENStem eco basic. If the device
and/or the cables are soiled, clean them using a soft, lint-free cloth. See "Accessories" for
electrode care.
6.10 Combining
The TENStem eco basic may only be combined with the articles listed in the scope of deliv-
ery and under "Accessories".
6.11 Technical safety controls (Section 11 MPBetreibV)
The technical safety controls include:
1. Inspection of accompanying documents for the presence of the instructions for use
and the medical devices book
2. Check of equipment for completeness
3. Visual inspection
– for mechanical damage
– all cables and connectors for damage