Legal notes

1     INTRODUCTION

The physician in charge has the sole medical responsibility for a rehabilitation treatment and decides whether a patient is fit for a specific treatment. In particular, the physician must weigh in each individual case possible risks and side-effects of the treatment against the expected benefit. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups. The person in charge of using the system is responsible to adapt the training sessions and the course of therapy to the patient’s abilities.

Being a scientific discipline, medicine is subject to constant advances of knowledge and treatment principles. The physician in charge must continually keep his knowledge up-to-date by reading the latest scientific literature and must monitor changes in use recommendations during the course of treatment.

2    PRODUCT DISCLAIMERS

2.1    Medical Devices

The Hocoma products listed below are medical devices and must be used in strict adherence to the User Manual; failure to do so may result in serious personal injury. It is strongly recommended that you regularly consult Hocoma’s website (www.hocoma.com) for the latest available information. Please contact Hocoma should you have any questions.

Use only under the supervision of qualified medical personnel. However, certain Hocoma products are marketed for home use and must be strictly used according to the recommendations of your medical care provider who is knowledgeable about your specific needs. Consult the User Manual and Hocoma’s website (www.hocoma.com) for appropriate product designation. Failure to obtain and follow the recommendations of your medical care provider may result in serious personal injury.

This information provides details about medical products which may not be available in all countries and may not have received approval or market clearance by all governmental regulatory bodies throughout the world. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any specific use for any product which is not authorised by the laws and regulations of the country where the reader of this information resides.

For more detailed information about the application of our medical devices please refer to these sections:

2.2 Health Software (Non-Medical Device) HocoNet®

HocoNet must be used in strict adherence to the HocoNet User Manual. It is strongly recommended that you regularly consult Hocoma’s website (www.hocoma.com) for the latest available information. Please contact Hocoma should you have any questions. Consult the User Manual to verify that you are using the product as intended.

Although not a medical device, HocoNet may not be available in all countries and may not have received approval or market clearance by all governmental regulatory bodies throughout the world. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any specific use for any product which is not authorised by the laws and regulations of the country where the reader of this information resides.

2.3 Partner Devices

3rd party products that may be mentioned by Hocoma are not covered by Hocoma legal notes and customers and visitors should visit the respective 3rd party websites for more information.

For products manufactured by Motek Medical B.V. please visit www.motekmedical.com