Proxomed 10350100, Руководство пользователя

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User Manual Page 2 Version 05
1.3 Classification
According to the Medical Product Law (in German MPG) the tergumed ® 710 machine is a Class 1 medical device
with a measurement function.
The machines are compliant with the requirements of EN ISO 20957-1 / ISO 20957-2-class S (= Studio) or I (=
Rehab) and are intended for use in industrial facilities. Compliance with the Directive 93/42 EEC annex V for medical
machines is regularly monitored by the TÜV SÜD Product Service according to ISO 13485 Medical Devices - Quality
Management Systems. Each machine is uniquely identified by a corresponding type plate.
Note:
The machines are subject to an annual technical safety check (TSC) and every two years a technical
measurement check (TMC).
The tergumed ® 710 frame assemblies consist of welded steel structures and are coated with a high-quality powder
coating to protect against moisture and perspiration and are thus also protected from rust. Finally, the machines are
completely assembled in the Assembly Department and equipped with high-quality measurement and tested
according to defined criteria.
Through the use of ground rods, guides made from plastic and special ball bearings, the machines are largely
maintenance-free. There is however some maintenance necessary, please refer to information in section 8 of this
User Manual.
2 Identification and Specification
This User Manual is valid for the following machines:
Item number Identifier User weight Weight block
10350100
tergumed
®
710 Extension 180 kg 84 kg
10350200 tergumed ® 710 Flexion 180 kg 84 kg
10350300 tergumed ® 710 Rotation 180 kg 84 kg
10350400 tergumed
®
710 Lateral flexion 180 kg 84 kg
10350500 tergumed ® 710 Cervical Trainer 180 kg 12.5 kg