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 the pertaining user manuals.

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

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Armeo®Spring Pro, Armeo®Spring, Manovo®Spring, and Armeo®Spring Pediatric

Indications

The ArmeoSpring Pro, ArmeoSpring, ManovoSpring, and ArmeoSpring Pediatric are intended for the rehabilitative treatment of patients with mild to moderate impairments in upper limb function. These impairments can be caused by different diseases.

Contraindications

To avoid causing harm to a patient, the ArmeoSpring Pro, ArmeoSpring, ManovoSpring, and ArmeoSpring Pediatric must not be used if the following contraindications are present:

  • Orthosis cannot be fitted to the relevant upper extremity.
  • Bone instability in the relevant upper extremity (non-consolidated fractures, severe osteoporosis).
  • Non-stable vital functions that require external instrumental support for cardiac or pulmonary circulation (e.g. mechanical ventilation, external pacemaker).
  • Medical contraindication to bring the patient into a sitting position.
  • Before starting therapy with the Armeo®Spring Pro, Armeo®Spring, Manovo®Spring, and Armeo®Spring Pediatric, the therapist must convey the contraindications to the patient.

Risk Factors

In addition to the above list of contraindications, there are several risk factors, which do not necessarily preclude a patient from training, but require the therapist or treating clinician to evaluate the benefit of continuing treatment vs. the risk.

Each one of these conditions can be a risk factor if present to a low to moderate degree and as a single factor but can also become a contraindication if present to a more marked degree and/or if several conditions are present simultaneously.

If any or several of these conditions are present, additional safety measures are required, for example regular monitoring of vital signs during training. The more risk factors present and/or the more serious they are in an individual patient, the more likely it becomes that the use of the device is contraindicated.

The training should be immediately terminated as a consequence of any potentially dangerous situation arising from the below-listed risk factors.

  • Open skin lesions in the relevant areas of the upper extremity
  • Paresthesia
  • Shoulder joint subluxation or pain in the shoulder joint
  • Severe spasticity
  • Severe spontaneous movements, e.g. ataxia, dyskinesia, myoclonic jerks
  • Severe postural instability
  • Severe visual problems (patient is not able to see displayed elements on the computer screen)
  • Severe cognitive deficits
  • Confused or non-cooperative behaviour
  • Need for long-term infusion therapy, (e.g. intra-venous catheter, PEG tube)
  • Patients requiring isolation due to infections
  • Epilepsy
  • Pronounced, fixed contractures affecting the relevant upper extremity
  • Anesthesia or analgesia preventing sensory feedback regarding the cuff fixations or for controlling the range of motion in the relevant upper extremity
  • Cybersickness
  • Pusher syndrome

The above lists do not claim to be exhaustive. The clinician in charge has the sole medical responsibility for the rehabilitation treatment and for deciding whether a patient is fit for a specific treatment. In particular, the clinician must weigh in each individual case the possible risks and side effects against the expected benefits. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups. The treating clinician is responsible for adapting the training sessions and the course of therapy to the patient’s abilities.

Due to the constant advances in medical knowledge and treatment, the clinician in charge must continually keep up to date by reading the latest scientific literature and being informed of changes in treatment recommendations.

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