Composition Conformity Statement; Technical Maintenance; End Of Life; Safety And Electrical Standards - Winback Back4 Manuel Utilisateur

8.2 COMPOSITION CONFORMITY STATEMENT

The BACK4 device does not incorporate, as an integral part, any medicinal product, human blood or derivatives.
The device does not incorporate tissue of animal origin.

8.3 TECHNICAL MAINTENANCE

If any parts or accessories are defective, please contact SWIMS S.A.S./WINBACK after-sales service (sav@
swims.team).
The life expectancy of the BACK4 device is 5 years. However, to guarantee maximum efficiency, maintenance
must be carried out every 2 years.
During this maintenance, output power and general performance will be checked to ensure the efficiency and
safety of the device are still compliant with the manufacturer's standards.

9. END OF LIFE

Reflecting prevailing regulations, SWIMS S.A.S./WINBACK supports the DEEE Pro ecosystem recycling
program, which collects used medical material free of charge.
At the end of its life, return your BACK4 to: SWIMS S.A.S./WINBACK - Les Bureaux du Parc - 2474 RD 6007 -
06270 Villeneuve-Loubet, France. If you are located outside Europe, contact SWIMS S.A.S company – for details
of the address to return your device to.

10. SAFETY AND ELECTRICAL STANDARDS

The BACK4 device is a Class IIa medical device with Class C software.
To ensure optimal safety and efficiency, the BACK4 has been developed and manufactured in accordance with
the following standards:
Name
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971:2014
93/42/EEC
ISO 13485:2016
2014/53/EU
In accordance with Directive 93/42/EEC, the following tables provide information regarding the EMC
characteristics of this electromedical equipment.
For details of all the tests carried out on BACK4, refer to the electrical safety and EMC testing report with regard
to ISO 60601-1 and ISO 60601-1-2.
48
Description
General requirements for the safety of medical electrical systems
Electromagnetic compatibility for medical devices
Medical electrical equipment – Part 2-10: specific requirements for basic safety and essential
performance of nerve and muscle stimulators
Application of risk management to medical devices
Essential requirements for medical devices
Quality management systems for medical devices
Radio equipment directive (RED)