Legal notes

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.

PRODUCT DISCLAIMERS

Medical Devices

The Motek Medical B.V. 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 our website (www.motekmedical.com/) for the latest available information. Please contact Motek Medical B.V. should you have any questions. Use only under the supervision of qualified personnel.

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 following sections.

GRAIL and M-Gait

Indications

The M-Gait and GRAIL can be used for patients with balance or gait disabilities, caused by conditions of neurological, orthopedic, muscular, cardiovascular or other origin, as well as able-bodied individuals. Indication for assessment and training with the M-Gait must be judged on a case by case basis by a certified operator.

The M-Gait and GRAIL can be used for patients with the following conditions in particular:

· Stroke

· Cerebral Palsy

· Lower limb amputees

· Knee ostheoartritis

· COPD

· Healthy older adults

· Healthy young adults

Contraindications

As with any other therapy, the clinician in charge is always responsible for decisions regarding indications and contraindications. Functional therapy with the GRAIL or M-Gait is not possible or indicated in every case. In general, the GRAIL or M-Gait must not be used in the following conditions to avoid causing harm to the patient:

· A severe cognitive, visual or hearing impairment where the subject is not able to follow the instructions of the operator

· Less than 20kg total bodyweight

· More than 135kg total bodyweight

· Open skin lesion or bandage in the area of harness contact

· Patients with FAC score of 1 (i.e. patient needs frim continuous support from one person who helps carrying weight and with balance) or lower

The above list does not claim to be exhaustive. The clinician 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 clinician must, in each individual case weigh possible risks and side effects against 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 therapist is responsible for adapting the training sessions and the course of therapy to the patient’s status.

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

Risk Factors

In addition to the above list of contraindications, there are several risk factors that do not necessarily lead to an exclusion of a patient from training but require increased caution during the planning and execution of training.

The training should be stopped immediately as a consequence of any potentially dangerous situation arising from any of the following risk factors:

· Severe reduced bone density

· Spinal instability or unstable fractures

· Severe cardiovascular disorders or cardiac abnormalities that affect the ability to exercise safely

· Running for patients with FAC score of 4 (i.e. patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces) or lower

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CAREN Extended and CAREN High-End

Indications

The CAREN Extended and CAREN High-End (hereafter CAREN) can be used for patients with balance or gait disabilities, caused by conditions of neurological, orthopedic, muscular, cardiovascular or other origin, as well as able-boedied individuals. Indication for assessment and training with the CAREN must be judged on a case-by-case basis by a certified operator. The CAREN can be used for patients with the following conditions in particular:

· Vestibular disorders

· Traumatic brain injury

· Lower limb amputees

· Stroke (chronic and subacute)

· Multiple sclerosis

· Parkinson’s disease

· Post Traumatic Stress Disorder

Contraindications

CAREN training may not be conducted if one of the following conditions is present:

· A severe cognitive, visual or hearing impairment where the subject is not able to follow the instructions of the operator

· Less than 20kg total bodyweight

· More than 135kg total bodyweight

· Open skin lesion or bandage in the area of harness contact

· Patients with FAC score of 1 (i.e. patient needs frim continuous support from one person who helps carrying weight and with balance) or lower

Risk Factors

In addition to the above list of contraindications, there are several risk factors, which do not have to exclude a patient from training but require increased attention of the person in charge of using the system with respect to the applicable risk factors.

· Severe reduced bone density

· Spinal instability or unstable fractures

· Severe cardiovascular disorders or cardiac abnormalities that affect the ability to exercise safely

· Running for patients with FAC score of 4 (i.e. patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces) or lower

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C-Mill

Indications

The C-Mill can be used for elderly with increased fall risk and patients with neurological, cardiovascular or orthopedic conditions affecting balance and gait.

Contraindications

C-Mill training may not be conducted if one of the following conditions is present:

· A severe cognitive, visual or hearing impairment where the patient is not able to follow the instructions of the therapist.

· More than 135 kg total bodyweight

· More than 2.00 meter body height

· Open skin lesion or bandage in the area of harness contact.

· < FAC 2

When using the C-Mill with BWS the following contraindications apply:

· A severe cognitive, visual or hearing impairment where the patient is not able to follow the instructions of the therapist.

· More than 135 kg total bodyweight

· More than 1.90 meter body height

· Open skin lesion or bandage in the area of harness contact.

· < FAC 1; i.e. cannot walk, or needs help from 2 or more persons

· Pregnancy

Risk Factors

C-Mill:

· Severe reduced bone density

· Spinal instability or unstable fractures.

· Severe vascular disorders or cardiac abnormalities that affect the ability to exercise safely

· Running < FAC 5

C-Mill with BWS:

· Severe reduced bone density

· Spinal instability or unstable fractures

· Severe vascular disorders or cardiac abnormalities that affect the ability to exercise safely

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RYSEN^TM

Indications

The RYSEN™ is intended for treatment of patients with gait and/or balance impairment, caused by conditions of neurological, orthopedic or other origin.

Contraindications

RYSEN™ training may not be conducted if one of the following conditions is present:

– Patient weights more than 135 kg (300lbs) or less than 15 kg (34lbs)

– Patient height is more than 200 cm (79’) or is less than 100 cm (39’)

– Risk Factors

Risk factors for training with the RYSEN™ are:

– Medication affecting exercise tolerance

– Subjects with vascular, respiratory, cardiac or orthopedic disorders that affect the subject’s ability to exercise safely

– Sensory impairment in the lower limbs and trunk, especially reduced pain sensation

– Spasticity

– A cognitive, visual or hearing impairment where the subject is not bale to follow the instructions of the operator

– Considerably reduced bone density (osteopenia or osteoporosis)

– Joint contractures

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 or the use of a brace or an insole. 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 devices is contraindicated.

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Legal notes

INTRODUCTION

PRODUCT DISCLAIMERS

Medical Devices

GRAIL and M-Gait

CAREN Extended and CAREN High-End

C-Mill

RYSEN^TM

Products

Clinical practice

Research

Training Material

User Manual

Expert section

Contact us

Motek is a proud partner of:

Legal notes

INTRODUCTION

PRODUCT DISCLAIMERS

Medical Devices

GRAIL and M-Gait

CAREN Extended and CAREN High-End

C-Mill

RYSENTM

Products

Clinical practice

Research

Training Material

User Manual

Expert section

Contact us

Motek is a proud partner of:

RYSEN^TM