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The Myomo™ e100 NeuroRobotic System™ is intended for clinical use by patients with their treating medical professional. The device has not been shown to be safe or effective as a functional aid for use in the home.
Indications and Contraindications
Observe the following indications and contraindications for using the Myomo e100 NeuroRobotic System.
Indications
The Myomo e100 NeuroRobotic System is indicated for use by stroke patients undergoing rehabilitation to facilitate the
following:
- Stroke rehabilitation by muscle re-education
- Maintain or increase range of motion
Contraindications
The Myomo e100 NeuroRobotic System should not be used by patients with any of the following conditions:
- Shoulder dislocation or patients who cannot safely support the weight of their arms plus 3 lbs(1.36 kg) (the weight of the device)
- Unable to safely bear a torque of 14 Newton Meters (Nm) or less on their elbow
- Recent history of muscle spasms
- Rigid contracture in the upper arm
- Elbow flexor or extensor (biceps or triceps, respectively) that is greater than 3 on the Modified Ashworth Scale (MAS) for spastic hypertonia, which may impair passive motion
- Passive range of motion (PROM) not greater than zero degrees of extension
If, at any time during the use of this device, the patient notices any of the following, he or she should immediately discontinue use and seek guidance from his or her physician or therapist:
- Persistent redness, swelling, or skin breakdown (bleeding, chafing, etc.) in the region around the sensors or in the regions around the edge of the device
- Rashes on the arm
- Shoulder pain correlated with wearing the Myomo e100 NeuroRobotic System
- Frequent uncontrolled and unintentional movement
Warnings
The following warnings apply to using the Myomo e100 NeuroRobotic System:
- Standard therapy precautions should be taken when using the device on a patient with shoulder subluxation.
- The Myomo e100 NeuroRobotic System is a prescription device and should only be used under direct clinical supervision.
- When prescribing exercises that use the Myomo e100 NeuroRobotic System, the standard therapeutic judgment in regards to shoulder strength and stability should be used to pick appropriate exercises. Use of this device on patients without consideration of the stability and strength of the patient's shoulder may cause shoulder pain or discomfort.
- When using the device in shoulder positions where it is possible for the patient to hit him or herself, use caution.
- Therapy should be discontinued immediately if device torque does not match patient's desired motion.
- Repairs should be made only by authorized personnel or by the manufacturer. Any attempt to open or repair control unit or brace will void the warranty.
- The Myomo e100 NeuroRobotic System should only be operated in temperatures ranging from 32°F to 104°F (0°C to 40°C).
- DO NOT submerge device in liquid. The device may be cleaned using a soft cloth lightly dampened with Isopropyl Alcohol or with a sanitary wipe only. The pads are machine washable, in cold water. Air dry after washing.
- Allow for adequate ventilation of the control unit. If control unit is placed into a gas-tight container, collection of battery fumes may cause explosion.
- Ship the Myomo e100 NeuroRobotic System, postage prepaid, to the Myomo™ Service Center for proper disposal or recycling. Please enclose a note indicating that the system is being returned for disposal or recycling.
- The control unit contains a NiMH battery pack that MUST NOT be incinerated.
- DO NOT expose control unit or battery to flame or excessive heat; personal injury may occur.
- The Myomo e100 NeuroRobotic System is not suitable for use in the presence of flammable anaesthetic mixtures with air, or flammable anaesthetic mixtures with oxygen or nitrous oxide.
- Tight straps may restrict the patient's circulation. Therefore, always check that the straps are not too tight throughout a patient's range of motion.
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