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

back to top

ArmeoPower

Indications

The ArmeoPower is intended for the rehabilitative treatment of patients with severe to moderate impairments in upper limb function. These impairments can be caused by different diseases.

Contraindications

Just as for any other therapy, the physician in charge is always responsible for the indication. Functional therapy with the ArmeoPower is not possible or indicated in every case. In general, the ArmeoPower must not be used in the following cases to avoid causing harm to the patient. The following contraindications must therefore be observed in particular:

  • Orthosis cannot be fitted to the training arm
  • Bone instability in relevant areas of the upper extremity (non-consolidated fractures, frail fractures due to osteoporosis)
  • Fixed contractures affecting the relevant extremity (e.g. frozen shoulder)
  • Shoulder instability with uncontrolled shoulder displacement during the ArmeoPower training
  • Severe pain syndromes caused or intensified by the ArmeoPower training
  • Unstable vital functions (pulmonary or cardio-circulatory)
  • Medical contraindication to bring the patient into a sitting position
  • Patients requiring isolation due to infections
  • Epileptic disorder with frequent seizures bearing the risk of experiencing a seizure during the ArmeoPower training

The above list does not claim to be exhaustive. The decision as to whether a patient is suitable for therapy always comes under the remit of the physician in charge, who has sole medical responsibility for the therapy. As part of this, he must evaluate, in each individual case, possible risks and adverse effects of the therapy against the potential benefits.

Here, the patient’s individual situation plays just as an important role as the basic risk assessment for specific patient groups.

It is the duty of the person in charge of using the system to adapt the therapy sessions and course of therapy to the patient’s abilities and best possible outcome.

Because of new discoveries and advances, medicine as a scientific discipline is subject to constant change. It is the responsibility of the responsible physician to constantly update the state of his knowledge by means of current scientific specialist literature, and to acquire new knowledge regarding therapy advances. In case anything is unclear or you have feedback, please contact Hocoma (www.hocoma.com).

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.

The ArmeoPower training has to be immediately terminated as a consequence of any potentially dangerous situation arising from any of the following risk factors:

  • Orthopedic or rheumatologic disease, severely affecting the relevant extremity
  • Open skin lesions or skin disease in relevant areas of the upper extremity
  • Osteoporosis
  • Shoulder joint subluxation
  • Spasticity
  • Epileptic disorder
  • Anesthesia or analgesia preventing sensory feedback regarding the cuff fixations or for controlling the range of motion in the relevant upper extremity
  • Need for (long-term) infusion therapy, e.g intra-venous catheter, PEG tube
  • Risk of spontaneous movements, e.g. due to myoclonus, dystonia, dyskinesia, hemiballismus
  • Postural instability
  • Visual problems (patient is not able to see displayed elements on the computer screen)
  • Cyber sickness
  • Neglect syndrome
  • Cognitive deficits
  • Confusion, somnolence, uncooperative or (self-)aggressive behavior
  • Pusher syndrome

The above list is not exhaustive. If present at a low to moderate degree and as a single factor, each one of these conditions can be a risk factor. However, these conditions can become a contraindication if present to a more marked degree and/or in combination with one or more other conditions simultaneously. The more risk factors are present and/or the more serious they are in an individual patient, the more likely it becomes that use of the device is contraindicated.

back to top

ArmeoSpring Pro

Indications

The ArmeoSpring Pro and ManovoSpring 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, including, but not limited to, neurological diseases, such as acquired brain injury (through stroke or trauma), and cerebral palsy.

Contraindications

To avoid causing harm to a patient, the ArmeoSpring Pro and ManovoSpring 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 ArmeoSpring Pro, 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.

ArmeoSpring Pro 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.

back to top

Lokomat

Intended use

The intended use of the Lokomat is to increase the strength of muscles and the range of motion of joints in order to improve walking.

Contraindications

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

  • Considerably reduced bone density (osteopenia or osteoporosis). Hereby, due to the forces exerted on the lower extremities, no Lokomat training may be conducted in patients where considerable bone density loss and an increased risk of fractures can be suspected from their history (for example in individuals who had prolonged reduced weight bearing), or in patients where considerable bone density loss has even been diagnosed.
  • Training is contraindicated if the person weighs more than 135 kg (297 lb.) or is taller than 2 m (78.7 in.) or than 1.95 m (76.7 in) (depending on the version). The Lokomat Devices are tested for persons up to 135 kg and 2 m body height. Persons taller or weighing more than this may not be trained in the devices for safety reasons.
  • Lokomat training is contraindicated if the person weighs less than 10 kg (22 lb.)
  • Non-consolidated fractures
  • Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, orthopedic conditions, cognitive deficits limiting communication, neuropsychological conditions, infections or inflammatory disorders, osteomyelitis…)
  • Fixed joint contractures that limit the range of motion of the orthosis
  • A proper fit of the harness and the orthoses is crucial. Lokomat training is therefore contraindicated in patients with an upper leg length of less than 21 cm (8.3 in.) or more than 35 cm (13.8 in.) (pediatric orthosis) or less than 35 cm (13.8 in.) and more than 47 cm (18.5 in.) (adult orthosis). Lokomat training is furthermore contraindicated in case of the inability to properly adjust the harness and/or orthoses to the respective body part due to:
    • Pregnancy
    • Colostomy bags
    • Uncorrectable differences in leg length
    • Skin lesions that cannot be protected appropriately
    • Any other reason that prevents a proper, pain-free adjustment of the harness and/or orthoses.

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.

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.

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

  • Arthroplasty (especially hip arthroplasty or arthroplasties where external hip rotation is contraindicated for the patient)
  • Uncontrolled hip, knee or ankle instability that would still pose a danger despite the body weight support (especially lateral instability when training with the FreeD module).
  • Lack of head control
  • Joint contractures or limitations in the range of motion due to spasticity that cannot be reduced
  • Differences in leg length correctable with an insole
  • Sensory impairment in the lower limbs and trunk, especially reduced pain sensation
  • Risk of autonomic dysreflexia (level at or above T6; history of AD increases the risk of having a reoccurring episode)
  • Recent history or elevated risk of seizures
  • Cardiac instable conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
  • Uncooperative or (self-)aggressive behavior (e.g., transitory psychotic syndrome)
  • Mechanical ventilation
  • Long-term infusions (e.g., baclofen pump, intrathecal pumps, PEG tube…) or stimulators (e.g. pacemakers, nerve stimulators)
  • Skin lesions (including pressure sores) in areas of contact with harness support, robotic orthosis (buttocks and along lower extremities) or lower extremity loading (feet).

There are populations with sensitive skin and comorbidities that impact the skin. Patients with Spinal Cord Injuries experience decreased sensation because of their injury or medical condition. Impaired sensation can lead to the development of pressure sores because the patient is unaware of any problem. They cannot tell the therapist if something if something hurts or does not feel right.

Older adults have gone through intrinsic changes, among them: reduction of collagen type I, elastin, fibroblasts and sebum secretion.

Pediatric patients have thinner skin that is more easily damaged.

  • Bariatric patients have less vascularization of the adipose tissue and are associated with other comorbidities.
  • HIV and AIDS patients are immuno-suppressed.
  • Comorbities that impact the skin:
    • Diabetes with microvascular and neurologic changes (prolonged wound healing)
    • Altered nutritional status
    • Altered hormone levels (estrogen, testosterone, GH)
    • Anemia
    • Atherosclerosis, decreased perfusion
    • Venous insufficiency
    • Any source of edema: lymphedema, venous stasis, hypoalbuminemia
    • Colonization of skin with fungus and pathogenic, multiple resistant bacteria
    • Pharmacologically compromised: corticosteroids, immunomodulators

These 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.
In the case of chronic patients or patients who have been immobile for a long period of time, short training sessions are recommended to begin with, using a high level of body weight support. An overreaction can be expected from these patients if the training sessions are too long. Increased development of osteoporosis in chronic patients has to be taken into account. On the other hand, some patients may have a certain euphoric reaction after the first treatment sessions, and want to have longer or more frequent training sessions. This can result, in the case of the patients described above, in excessive strain being exerted on ligaments, tendons, joints and bones, which can lead to hyperextension, tears and even spontaneous fractures.

back to top

Andago

Indications

Treating clinicians can decide to use the Andago as a therapeutic tool for patients with gait and balance impairments for which overground gait training is indicated, provided there are no product-specific contraindications and bearing in mind the risk factors.

Contraindications

As with any other therapy, the clinician in charge is always responsible for decisions regarding whether Andago V2.0 therapy is indicated or not. Specifically, therapies must only be used if the potential benefits outweigh the potential risks for the individual patient in question. When deciding whether Andago V2.0 therapy is indicated with a certain patient, the responsible clinician must carefully consider that the conditions listed below could increase the risk of harm to the patient.

In general, if the treating clinician decides that the potential benefits do not outweigh the potential harm for the respective patient, Andago V2.0 therapy is contraindicated. The clinician must also be aware that the risk/benefit profile of a certain patient could change over the duration of therapy as new information becomes available. Therefore, the clinician must continually monitor the results of therapy and periodically reconsider if Andago V2.0 therapy is still indicated.

Andago V2.0 training may not be conducted if one of the following conditions is present:

  • Andago V2.0 training may not be conducted in any case in which traditional over-ground training is contraindicated due to reduced bone density.
  • Training is contraindicated if the person weighs less than 10 kg (22 lb.) or more than 135 kg (297 lb.) or is smaller than 1.35 m (53.2 in.) or taller than 2 m (78.7 in.). Persons taller or weighing more than this may not be trained in the medical device for safety reasons.
  • Non-consolidated fractures.
  • Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, orthopedic conditions, cognitive deficits limiting communication, neuro-psychological conditions, infections or inflammatory disorders, osteomyelitis, etc.).
  • Andago V2.0 training is furthermore contraindicated in case of the inability to properly adjust the harness to the respective body part due to:
    • Pregnancy
    • Colostomy bags
    • Skin lesions that cannot be protected appropriately
    • Any other reason that prevents a proper, pain-free adjustment of the harness

Risk Factors

Arthroplasty (especially hip arthroplasty or arthroplasties where external hip rotation is contraindicated for the patient)

  • Uncontrolled knee or ankle instability that would still pose a danger despite the body weight support
  • Lack of head control
  • Joint contractures or limitations in the range of motion due to spasticity that can’t be reduced
  • Skin lesions (including pressure sores) in areas of contact with harness support or lower extremity loading (feet)
  • Sensory impairment in the lower limbs and trunk, especially reduced pain sensation
  • Risk of autonomic dysreflexia (level at or above T6; history of autonomic dysreflexia increases the risk of having a reoccurring episode)
  • Recent history or elevated risk of seizures
  • Cardiac conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
  • Uncooperative or (self-)aggressive behavior (e.g., transitory psychotic syndrome)
  • Mechanical ventilation
  • Long-term infusions (e.g., baclofen pump, intrathecal pumps, percutaneous endoscopic gastronomy tube…) or stimulators (e.g., pacemakers, nerve stimulators)

The list above represents current identified potential risks and known clinical risks. It does not claim to be exhaustive.

The clinician in charge has the sole medical responsibility for the rehabilitation treatment and decides whether a patient is fit for a specific treatment. In particular, the clinician in charge must weigh, in each individual case, the 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 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.

The maximum levels of damage which may be caused by first level failures of the Andago V2.0 or persons interacting with the system are documented in the Risk Management File (K).

It is important to bear in mind that risk factors may also be considered contraindications if they are present to a moderate degree and/or if several risk factors are presented simultaneously. The more risk factors present and the more serious they are in an individual patient, the more likely it is that use of the devices is contraindicated.

back to top

Erigo

Indications

Training with the Erigo is indicated in neurological, trauma, cardiovascular, and post-surgery patients. Neurological disorders include (but are not limited to):

  • Stroke
  • Spinal cord injury (SCI)
  • Traumatic brain injury

The Erigo can be used even in the following clinical situations that usually lead to reduced therapy options:

  • Permanent bladder catheters
  • Strong spasticity (Modified Ashworth Scale 3, considerable increase in tone – passive movement difficult)
  • Restricted lung function (e.g., artificial ventilation)
  • Patients with reduced state of consciousness (e.g., no head/trunk control)
  • Pediatric patients

Contraindications

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

  • Severe fixed contractures affecting the lower limbs (hip, knee, ankle joints)
  • Body weight greater than 135 kg (297 lb.)
  • Leg length (measured from the foot sole to the greater trochanter) less than 75 cm (29 in.) or greater than 100 cm (39 in.)
  • Patients with extremely disproportionate growth of the legs and/or spinal column (e.g. bone or cartilage dysplasia)
  • Harness and cuffs cannot be appropriately adjusted to the patient (e.g. due to patient size, shape, pain, skin conditions or others)
  • Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis, pseudarthrosis)
  • Cardiac contraindications
  • Uncooperative or (self-)aggressive behavior, such as transitory psychotic syndrome
  • In general, patients who have been ordered to remain in bed or immobile (e.g. osteomyelitis or other inflammatory/infectious disorders)
  • Vascular disorders of the lower limbs.

Additional contraindications to the use of the Erigo FES:

  • Cardiac pacemakers or other active electrical stimulators
  • Implanted medication pumps
  • Pregnancy (unknown adverse reactions)

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

  • Severe spasticity: in most cases spasticity is not an exclusion criterion; stretching exercises prior to training with the Erigo combined with individual adjustments of machine related parameters may however be necessary to reduce the likelihood of occurrence of spasticity.
  • Severe osteoporosis: in the case of an increased risk of fractures, training with the Erigo must be adjusted accordingly (milder cases in patients with spinal cord injuries do not necessarily constitute an exclusion criterion).
  • Dysesthetic pain syndrome: in some cases the pain can become so unpleasant that it is necessary to interrupt the training session.
  • Skin lesions or open wounds in areas of the body being treated
  • Autonomic dysreflexia: a potentially life threatening clinical syndrome that can develop in individuals with SCI, resulting in acute, uncontrolled hypertension.
    Additional risk factors regarding the use of the Erigo FES:
  • Implants: plates, nails, screws or other metal parts implanted less than 3 months prior to training underneath or near the group of muscles to be stimulated
  • Epilepsy: this disorder can constitute an exclusion criterion under certain circumstances, since possible adverse reactions are still unknown.
  • Allergic reaction to the gel used in the electrodes (ask your medical supplier for alternative products)

back to top