THERA-Trainer toro
medica - Medizintechnik GmbH · Model 01.YY.XX · UDI-DI 04041925006193
Description
The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The system is used in a seated position, e.g. in a wheelchair or suitable therapy chair. The movement is managed by the therapy drive unit and is limited in extent by the selected crank radius. The upper and lower extremities are driven by the same drive unit. The extremity arms and legs are never moved simultaneously by the therapy drive unit. The therapy drive unit drives a support device for legs (footrest) and arms (therapy grips) in a circular motion. The different positioning devices should be easily interchangeable by the operator. With the base frame and the electronic pivoting therapy drive unit, the therapy drive unit can be positioned individually in front of the user. Suitable devices guarantee a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The device can be easily transported to different places of use or storage by means of castors. The interfaces of the arm/leg accessory are designated in such a way that options from the current CL product portfolio can be used. This is intended to provide optimum protection for the user. The requirements are derived from the degree of disability of the user. Especially in clinics the point hygiene is very important, so an easy disinfection and cleaning is possible.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-01 | Btt Health Gmbh | Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic |
| 2019-07-29 | MOTEK MEDICAL B.V. | The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu |
| 2013-06-12 | Accelerated Care Plus Corporation | An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. |
| 2012-11-12 | BioMotion Medical Systems, LLC | BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin |
| 2011-07-15 | Alter-G, Incorporated | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
| 2009-05-27 | Hocoma AG | Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation |
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