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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PN 26216 Rev 006 5
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.

WARNINGS, CONTINUED
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Each component of the device is supplied for safety and best
performance. Use all provided components for optimal
operation.
No modification or disassembly of the mechanical or electrical
components of the MARK device is allowed as it may expose
other dangers.
If storing the MARK for more than one month, removethe
battery from the battery compartment.
Make any size or component swapping of the devicebefore
the MARK is on the User. Acceptable adjustments to make
after it is on the User are Forearm Bar length, Multi-
Articulating Wrist tensioning, and Thumb Saddlesize.
Some adjustments, such as retracting the Forearm Bar,
increase the amount of excess wire around the User’s arm.
Before powering the MARK on, ensure that any excess wire is
not at risk of catching on other objects in the environment.
Also check if there is enough wire slack to allow all movement
of the MARK device.
If at any time during the use of this device, the Clinician orthe
User notices any of the following, discontinue use, and
contact Myomo Support.
• Movement does not match the User’s desired motion.
• Persistent redness, swelling, or skin breakdown
(bleeding, chafing, etc.)
• Rash on the arm, hand, or fingers.
• Pain associated with wearing the MARK orthosis.
• Unusual noises from the orthosis (popping,clicking,
etc.)
• Smells from the orthosis (smoking, burning plastic, etc.)
• Odor from the orthosis (sour smells or other indications
of bio-contamination.)
Icon Credits
Medical Shield by Josy Dom Alexis, Weight: Deadlift by Scott Lewis, Single Person: Person by Alexander Smith, Group of People: Group Men by Peter van Driel,
Arm: Muscle by Jurjen Versteeg; the Noun Project

CAUTIONS
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The following cautions apply to the MARK device and accompanying components:
▲
Do not expose to flame or excessive heat.
▲Do not incinerate the Lithium Ion batterypack.
▲Do not use a hairdryer to dry components.
▲Use only the battery and battery charger provided with the MARK.
▲Insert only the battery pack that came with the MARK into thebattery
compartment.
▲Charge the battery indoors only. The battery and battery charger should only
be operated in temperatures ranging from 0-40 °C (32-104 °F).
▲The MARK and accessories are not waterproof. Take care to protect the
device from coming in contact with liquids. Never immerse, pour, orspray
water or other liquids directly onto the device. For proper cleaning
instructions, see Page 71.
▲Excess force applied to rotate the motors in either direction will
permanently damage the motors.
▲ The MARK is not suitable for use in the presence of flammable anesthetic
mixtures with air, or flammable anesthetic mixtures containing oxygen or
nitrous oxide.
▲If fumes, flames, or melting of components around the battery or battery
charger is detected, or the device is hot to touch, TURN THE DEVICE OFF
IMMEDIATELY, remove the device from the User, and contact Myomo
support.
▲Protect the MARK devices from damage; always use the carrying bag
provided with the unit to store or ship the MARK.
Icon Credits
Trees: Forest by Simone Fernandes, House: House by Numero Uno; the Noun Project

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BATTERY &
CHARGING

BATTERY & CHARGING
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▲CAUTION: Do not expose to flame or excessive heat.
▲CAUTION: If fumes, flames, or melting of components around the battery or battery charger is
detected, or the device is hot to touch, TURN THE DEVICE OFF IMMEDIATELY, remove the
device from the User, and contact Myomo support.
NOTE: Charge the battery before using the device.
CHARGE THE BATTERY BEFORE FIRST USE
It is customary for lithium-ion batteries to be put into “Shipping Mode” for transport. This is necessary for
air shipping, but not for ground shipping. To get the MARK device battery out of Shipping Mode, set up the
battery charger, and put the battery in the charging dock. The MARK will not turn on if the battery is still in
Shipping Mode.
SETTING UP THE CHARGER
▲CAUTION: Charge the battery indoors only. The battery and battery charger should only be
operated in temperatures ranging from 0-40 °C (32-104 °F).
▲CAUTION: Use only the battery and battery charger providedwith the MARK.
▲CAUTION: Do not expose to flame or excessive heat.
Step 1. Plug the charging cable into the charging
dock.
Step 2. Plug the 3-prong end
into a wall outlet.

CHARGING THE BATTERY
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NOTE: Charging time for a battery with <10% capacity is approximately 3hours.
Step 1. Locate the row of metal prongs inside the
charging dock.
Step 2. Locate the “teeth” on the battery.
Step 3. Align the teeth with the prongs inside the
charging dock and push down gently to sit the
battery fully onto the prongs.
Step 4. Check the light on the charging dock.
Flashing (blinking)
between RED & GREEN
The charger is detecting
the battery.
Illuminated
ORANGE
The battery is
charging.
Illuminated
GREEN
The battery is
charged.
Illuminated
RED
There is a problem with
the battery. Remove
the battery from the
charger and contact
Myomo Support.

OPENING AND CLOSING THE BATTERY COMPARTMENT
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To open the 1battery compartment, press the eject button.
To close the battery compartment, push firmly in the center of the compartment door until the door clicks
shut.
EJECT BUTTON
PUSH TO
CLOSE

INSERTING THE BATTERY INTO THE DEVICE
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▲CAUTION: Insert only the battery pack that came with the MARK into the battery
compartment.
To insert a charged battery into the MARK’s battery compartment:
1. Remove the battery from the charging port & unplug the Charging Dock from the wall outlet.
2. Open the battery compartment.
3. The battery only engages fully in the battery compartment in ONE DIRECTION. Locate the
“myopro” sticker on the battery – position the logo so that it faces toward the wearer’s arm
(medial), with the battery tab pointing up. This will line it up properly for step 4.
4. Gently insert the battery into the batterycompartment.
5. Close the battery compartment.

NOTES ON BATTERY HEALTH
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WARNING: If storing the MARK device for more than one month, remove the battery from the
battery compartment.
NOTE: If a battery is unused (stored), it should be recharged at least once every 6 months. If
uncharged for more than 6 months, the battery could get so depleted that it could be unable
to be recharged.
NOTE: Best practices for charging the battery:
• The battery is rated for 300 “charge cycles.” A charge cycle is from less than 10%charge
to 100% charge. If you charge once a day, the battery should last for 10 months.
• Lithium ION batteries deteriorate faster when the depth of discharge is higher.
Therefore, it is better to NOT fully deplete the battery before charging. Mid-cycle
charging (between 40-60% battery charge) will provide the bestlongevity.
NOTE: Batteries do not last forever. If the battery is not holding a charge for more than 30
minutes, or you have been using the battery consistently for more than 12 months, it may be
time for a new battery. Contact Myomo to order a new battery.
NOTE: The battery charger has an expected life of 3 years.
CHECK CHARGE LEVEL ON THE BATTERY
Press the black dot on the battery icon to see the
battery’s charge level. A light scale (1 to 4 lights) will
indicate the battery’s current charge range.
Visual
Indicator
One light blinks
for 1 second
and repeats
four times
One light
illuminated for
4 seconds
Two lights
illuminated for
4 seconds
Three lights
illuminated for
4 seconds
Four lights
illuminated for
4 seconds
Percent Charge Less than 10% 10-25% 26-50% 51-75% 76-100%
Icon Display

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CONTROL PANEL &
OPERATION

CONTROL PANEL BUTTONS & LIGHTS DIAGRAM
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Power Button
Elbow Mode Button
Biceps Light
Power Light &
Battery Capacity
Indicator (color)
Bluetooth Light
Triceps Light
Close Light
Open Light
Hand Mode Button