Safety and Performance Information

C-MILL

Intended purpose

The C-Mill is an instrumented treadmill intended to evaluate human gait and balance and to train (impaired) gait and balance.

Intended patient population

Intended for patients with balance or gait disabilities, caused by conditions of neurological, orthopedic, or other origin. Such conditions include but are not limited to stroke, cerebellar disorders, spinal cord injury, Parkinson’s disease, and amputation.

Intended part of the body

The operator interacts with the following parts/components:

• Safety harness

• BWS harness (C-Mill VR+)

• Handrails

• Emergency stops

• Monitor

• Keyboard

• Mouse

• Remote control (C-Mill VR+)

• Safety line

• Safety rope (C-Mill and C-Mill VR)

The patient interacts with the following parts/components:

• Emergency stops

• Handrails

• The safety harness (which is worn over the clothes)

• BWS harness (C-Mill VR+)

• Treadmill belt (through the footwear)

Intended users

Physiotherapists, physicians, and rehabilitation professionals/support employees specialized in gait and balance impairment rehabilitation. To ensure the safety of patients, users, and third parties, and to ensure successful therapy sessions, operators of the C-Mill must be trained by an instructor or trainer certified by Motek and must have read and understood the User Manual.

Other intended users are employees from Motek, the Production, Installation, Service, and Training departments who have been working on/ with the C-Mill. These users can be considered secondary users as their use does not involve working directly with patients.

User Qualification and Training

Dedicated product training by a Motek Medical B.V. certified instructor and certification by Motek is mandatory. There is no specific education level or prior experience required. These users can be considered primary users.

• Only properly trained people are authorized to use the C-Mill.

• Before someone is authorized to use the C-Mill, it is important to ensure that they have read and fully understood the User Manual and that they have been trained either by Motek
  or by others certified by Motek
  

• If necessary, clinical training on demand can be requested from Motek
  

• A list of authorized users must be kept for the C-Mill.

• Only authorized persons can have access to the device.

• Make sure that unauthorized persons do not tamper with the device.

• Only people certified or instructed by Motek
  can maintain, calibrate, troubleshoot, and repair the device.

• Any users of the C-Mill must comply with the information in the User Manual in full and without restriction.

• All people in the vicinity of the C-Mill must comply fully with the safety precautions described in the User Manual.

• The C-Mill may be used only when it has no technical faults and is safe to operate.

• Do not continue using the device and contact Motek
  Service in case of any incidents.

Obligations of the user

User’s personal responsibility:

• The user must be free of alcohol, drugs, and intoxicating medication (e.g., substances that could influence the driving ability or operation of heavy machinery).

• The user should be physically able, well-rested, healthy, and sane, fully capable of his tasks and responsibilities.

• The user should be strong enough to assist the patient.

User’s responsibility towards the patient:

• The user must make sure that the patient wears tight clothing and no loose jewelry during sessions (e.g., no loose jackets, ties, loose sleeves, wide sweaters, necklaces, bracelets, loose shoelaces, etc.)

• The user must make sure that the patient is wearing shoes.

• The user must make sure that the patient’s long hair is secured close to the head.

• The user must know the exact capabilities of the patient. Never exceed the capabilities of the patient.

• The user must not leave children unattended.

Intended environment

The indicated use environment is a professional rehabilitative environment including, but not limited to, hospitals, research institutions, rehabilitation centers, and physiotherapy clinics, that are specialized in gait and balance rehabilitation.

Contraindication

The following patient population, within the patient population indicated, has been contra-indicated:

Contraindicated for patient population

Contraindications C-Mill: Patient weighs more than 135 kg (300 lbs). Patient weighs less than 25 kg (55.2 lbs).* Patient height is more than 200 cm (79’’) for C-Mill HERO or 210 cm (83”) for C-Mill and C-Mill VR or 190 cm (75”) for C-Mill VR+. Patient height is less than 100 cm (39”). Patient has FAC** score of 1 (i.e., patient needs firm continuous support from one person who helps carrying weight and with balance). An inability to properly adjust the harness to the respective body part due to: Body shape Pregnancy Colostomy bags Skin lesions that cannot be protected appropriately Any other reason that prevents a proper, pain-free adjustment of the harness Contraindications C-Mill with BWS: Patient has FAC score of 0 (i.e., cannot walk, or needs help from 2 or more persons)

* To ensure reliable step detection for gait analysis and interactive applications.

** FAC: Functional Ambulation Categories.

• FAC 0: Patient cannot walk, or needs help from 2 or more persons.
• FAC 1: Patients needs firm continuous support from 1 person who helps carrying weight and with balance.
• FAC 2: Patient can walk with continuous or intermittent support of one person to help with balance and coordination.
• FAC 3: Patient can walk but requires verbal supervision/stand-by help from one person without physical contact.
• FAC 4: Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces.
• FAC 5: Patient can walk independently anywhere.

Risk factors

Each one of the contraindications describe above 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 products is contraindicated.

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.

• The following patient population, within the patient population indicated, is seen as risk factor:

Patient population with risk factor

Vascular, respiratory, cardiac, orthopedic, or other disorders that affect the patient’s ability to exercise safely Medication affecting exercise tolerance Sensory impairment in the lower limbs and trunk, especially reduced pain sensation A cognitive, visual, or hearing impairment that affects the patient’s ability to follow the instructions of the user Considerably reduced bone density (osteopenia or osteoporosis) Recent history or elevated risk of seizures, 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

Unacceptable Risks

None are foreseen.

Side effects

From the physical methods and/or mechanisms by which the device works to accomplish the intended purpose the following side-effect(s) have been identified:

• Discomfort due to the safety harness

• Skin irritation

• Projection-induced nausea

• This list does not claim to be exhaustive.

Before starting the session with the C-Mill, the therapist must convey the residual risks and side effects to the patient.