myomo MARK User manual

PN 26216 Rev 006
The Mobile Arm Rehabilitation Kit
User Manual

CONTACT INFORMATION
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UNITED STATES
EUROPE
Myomo Inc.
One Broadway, 14th Floor
Cambridge, MA 02142 USA
Tel: [phone] (Myomo Support)
Fax: [phone]
Compliance Solutions Ltd
116 Almond Road
Cumbernauld, Glasgow, G67 3LW,
Scotland, United Kingdom
Tel: [phone]
Email: [e-mail]
For sales information, email: [email protected]om
For customer support, email: [e-mail]
For more information about Myomo, visit: www.myomo.com
CAUTION: United States Federal Law restricts this device to sale by or on the order of a
physician or physical therapist.
COPYRIGHT NOTICE
© 2017 Mobile Arm Rehabilitation Kit (MARK)TM
No part of this guide may be reproduced, transmitted, transcribed, or translated without the written permission of Myomo.
Product name Mobile Arm Rehabilitation Kit (MARK), and company name Myomo, mentioned herein are trademarks of Myomo,
Inc. or their respective owners. Other product and company names are used herein for identification purposes only and may be
trademarks of their respective companies.
The information contained in this document represents the current view of Myomo as of the date of publication and is subject to
change without notice. Because Myomo must respond to changing market conditions, it should not be interpreted to be a
commitment on the part of Myomo and cannot guarantee the accuracy of any information presented after the date of
publication.
The MARK mechanical assembly has an expected life of five years. This statement is not a service warranty or a guarantee of
access to a service warranty. This information is provided to assist in planning.

CONTENTS
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Topic
Page
INTRODUCTION ..………………………………………………………………………………………………………………………. 5
WARNINGS & CAUTIONS ..………………………………………………………………………………………………………… 9
BATTERY & CHARGING ………………………………………………………………………………………………………………. 13
CONTROL PANEL & OPERATION ………………………………………………………………………………………………… 19
SETTINGS & MODES ………………………………………………………………………………………………………………….. 23
ORTHOSIS DIAGRAMS ………………………………………………………………………………………………………………. 31
PUTTING THE ORTHOSIS ON A USER (“DONNING”) ………………………………………………………………….. 35
HARNESS …………………………………………………………………………………………………………………………………… 47
HAND ADJUSTMENTS ……………………………………………………………………………………………………………….. 51
WRIST ADJUSTMENTS ……………………………………………………………………………………………………………….. 59
FOREARM ADJUSTMENTS …………………………………………………………………………………………………………. 65
UPPER ARM ADJUSTMENTS ………………………………………………………………………………………………………. 69
CHECK THE FIT …………………………………………………………………………………………………………………………… 73
TAKING THE ORTHOSIS OFF OF A USER (“DOFFING”) ………………………………………………………………… 75
MAINTENANCE & TROUBLESHOOTING ……………………………………………………………………………………… 77
TECHNICAL SPECIFICATIONS & MARKINGS …………………………………………………………………………………
87

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INTRODUCTION

INFORMATION SYMBOLS
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▲
INTENDED USE
The Mobile Arm Rehabilitation Kit (MARK), an upper limb orthosis, is a compensatory device to increase the
ability to perform functional tasks with the affected limb. The user voluntarily activates movement of the
orthotic device with their remaining electromyography (EMG) muscle signal.
INDICATIONS FOR USE
The MARK is indicated for use by adolescents and adults diagnosed with long-term muscle weakness OR
partial paralysis. Users must meet physical size specifications and demonstrate to use the device, including
sufficient cognitive abilities, per user assessment and clinician evaluation.
CONTRAINDICATIONS
MARK devices are contraindicated for use as follows:
1. Insufficient myoelectric signal output from at least one muscle group needed to activate the
desired powered joint (for example, biceps or triceps signal to extend the affected elbow).
2. Severe shoulder subluxation.
3. Excessive pain in shoulder, arm or hand during facilitated range of motion.
4. Contraindicated during recovery from acute injury such as trauma, infection, or skin condition.
5. Upper extremity contracture(s) that prevent functional movement to benefit from the orthosis.
6. Rigid spasticity in the affected muscle groups.
7. Arm circumferences and lengths that are outside build specifications required to be fit with the
orthosis.
8. Cognitive or behavioral impairment that would inhibit safe use of theorthosis.
9. Other medical issue which interferes with safe use of the device for functional improvement.
WARNING
Warns about situations involving the use of electricity and other situations that could
result in bodily harm.
CAUTION
Cautions about actions that may create unsafe conditions that could result in damage
to the equipment or loss of data.
NOTE
Note about something to be aware of at this stage of MARK use that will help
optimize performance or help avoid a common issue that new Users may face.

MARK DESCRIPTION
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The MARK consists of two custom-fabricated, adjustable upper limb orthoses (braces), one for a left arm
and one for a right arm. Each MARK device (26215) is built with a powered elbow orthosis with surface
electromyography (EMG) sensors, a powered hand orthosis with surface EMG sensors, a manually set,
multi-articulating wrist (MAW) for wrist flexion, extension, pronation and supination, as well as the
following components:
Component Part Number
A shoulder harness for added comfort, stability, and ease of supporting the
weight of the device
25781 (left)
25782 (right)
An interchangeable, lithium-ion battery pack 25626
A battery charging dock 25687
A carrying bag 25881
A size-adjustment kit 26371
An extra parts kit 26372
Each Kit also comes with a Windows laptop and laptop charger (1879) that is pre-downloaded with the device’s
software, and a laptop carrying bag (26269). A Clinical Provider can use this software to view a graphical
representation of the User’s EMG signal while operating the MARK, and to adjust the User’s settings for optimal
performance.
The EMG-control circuit of the MARK continuously monitors and senses, but does not stimulate, the User’s muscles.
The MARK filters and processes the EMG signal, and translates this information into motor movement. Based on the
User’s needs and abilities, the control parameters are adjusted by the Clinical Provider. The power assist moves the
motor with speed proportional to the User’s exertion. This system enables the MARK to assist the User to initiate and
complete desired motions.
The MARK is designed for use in a clinical environment away from areas with high flammability risk. Please reference
Warnings and Technical Specifications for additional information. It should not be warn while undergoing medical
imaging (x-ray, MRI, CT scan, etc.)

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WARNINGS &
CAUTIONS

WARNINGS
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The following statements warn against injury risk when using the MARK:
The MARK devices are certified medical devices and should
only be used as indicated under clinical supervision.
ONLY use the MARK upper limb orthosis on the prescribed
elbow, wrist and hand joints. Each device is built specifically
for a left arm or a right arm; never put the right-sided device
on a left arm, or the left-sided device on a right arm.
Do not allow the User to drive an automobile or operate
machinery while wearing a MARK device.
Do not allow the User to sleep while wearing the MARK device
as the straps may alter the user’s circulation.
DO NOT expose the MARK device to flame or excessive heat;
personal injury may occur.
The MARK device is NOT waterproof. Do not allow the User to
shower, swim, or expose the device to rain or other sources of
water. Do not allow the User to wear the device for assistance
to wash dishes by hand as risk for water exposure to the hand
motor is high.
Caution the User when operating the device in shoulder
positions where it is possible for the User to hit him or herself.
Do not allow the User to attempt to lift heavy objects withthe
MARK device; the elbow motor provides at most 5 pounds of
lifting assistance.
Tight straps may restrict the User’s circulation.Therefore,
always check that the straps are not too tight throughout the
User’s range of motion.