1. Manuals
  2. Brands
  3. myomo Manuals
  4. Medical Equipment
  5. MARK
  6. User manual

myomo MARK User Manual

The mobile arm rehabilitation kit
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
The Mobile Arm Rehabilitation Kit

User Manual

PN 26216 Rev 006

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the MARK and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for myomo MARK

Summary of Contents for myomo MARK

  • Page 1: User Manual

    The Mobile Arm Rehabilitation Kit User Manual PN 26216 Rev 006...
  • Page 2 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.

  • Page 3: Table Of Contents

    CONTENTS Topic Page INTRODUCTION ..………………………………………………………………………………………………………………………. WARNINGS & CAUTIONS ..………………………………………………………………………………………………………… BATTERY & CHARGING ………………………………………………………………………………………………………………. 13 CONTROL PANEL & OPERATION ………………………………………………………………………………………………… SETTINGS & MODES ………………………………………………………………………………………………………………….. ORTHOSIS DIAGRAMS ………………………………………………………………………………………………………………. PUTTING THE ORTHOSIS ON A USER (“DONNING”) ………………………………………………………………….. HARNESS …………………………………………………………………………………………………………………………………… HAND ADJUSTMENTS ……………………………………………………………………………………………………………….. WRIST ADJUSTMENTS ……………………………………………………………………………………………………………….. FOREARM ADJUSTMENTS ………………………………………………………………………………………………………….
  • Page 4 PN 26216 Rev 006...

  • Page 5: Introduction

    INTRODUCTION PN 26216 Rev 006...

  • Page 6: Intended Use

    Users may face. 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.
  • Page 7 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.
  • Page 8 PN 26216 Rev 006...

  • Page 9: Warnings & Cautions

    WARNINGS & CAUTIONS PN 26216 Rev 006...
  • Page 10 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;...
  • Page 11 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, remove the battery from the battery compartment.
  • Page 12 ▲ Use only the battery and battery charger provided with the MARK. ▲ Insert only the battery pack that came with the MARK into the battery 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).

  • Page 13: Battery & Charging

    BATTERY & CHARGING PN 26216 Rev 006...
  • Page 14 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.

  • Page 15: Charging The Battery

    RED & GREEN GREEN There is a problem with The charger is detecting The battery is The battery is the battery. Remove the battery. charging. charged. the battery from the charger and contact Myomo Support. PN 26216 Rev 006...
  • Page 16 OPENING AND CLOSING THE BATTERY COMPARTMENT To open the 1battery compartment, press the eject button. EJECT BUTTON To close the battery compartment, push firmly in the center of the compartment door until the door clicks shut. PUSH TO CLOSE PN 26216 Rev 006...
  • Page 17 INSERTING THE BATTERY INTO THE DEVICE ▲ 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.
  • Page 18 NOTES ON BATTERY HEALTH 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.

  • Page 19: Control Panel & Operation

    CONTROL PANEL & OPERATION PN 26216 Rev 006...
  • Page 20 CONTROL PANEL BUTTONS & LIGHTS DIAGRAM Power Light & Battery Capacity Power Button Indicator (color) Bluetooth Light Elbow Mode Button Triceps Light Biceps Light Close Light Open Light Hand Mode Button PN 26216 Rev 006...
  • Page 21 CONTROL PANEL LIGHTS, DESCRIBED POWER LIGHT & BATTERY CAPACITY INDICATOR COLOR NOT Illuminated (off) The device is powered OFF. The device is powered ON. Illuminated Green The battery has greater than 15% charge remaining. The device is powered ON. Illuminated Yellow The battery has between 15% and 5% charge remaining.
  • Page 22 WARNING: Do not allow the User to attempt to lift heavy objects with the MARK device; the elbow motor provides at most 5 pounds of lifting assistance.

  • Page 23: Settings & Modes

    SETTINGS & MODES PN 26216 Rev 006...
  • Page 24 SENSITIVITY SETTINGS, OVERVIEW Each MARK User will have unique sensitivity settings. These settings correspond to how the device detects and responds to the User’s muscle signal. The sensitivity may need to be adjusted over time as the User continue to use the device. The different sensitivity settings are described below.
  • Page 25 MODES EXPLAINED WARNING: Use caution when using the device in shoulder positions where it is possible for the User to hit him or herself. The device may be operated in a variety of modes. The different modes allow the device to respond to different muscles, either by way of activation or by way of relaxation.
  • Page 26 ELBOW MODES In this mode, neither the Biceps or Triceps Light will be illuminated. The elbow motor will not respond to EMG signal from either muscle group. Though the device is powered on, no assistance is being given to the User’s elbow, and the arm will neither flex nor Standby mode extend.
  • Page 27 ELBOW MODES, CONTINUED In this mode, the Triceps Light will be illuminated. The elbow motor will respond to triceps EMG signal. Triceps mode Actions: • When User relaxes triceps, the elbow will flex. • When User contracts triceps, the elbow will extend. In this mode, both the Biceps and Triceps Light be will illuminated.
  • Page 28 HAND MODES In this mode, neither the Close or Open Light will be illuminated. The hand motor will not respond to EMG signal. Though the device is powered on, no assistance is being given to the User’s hand, and the hand will neither open nor close.
  • Page 29 HAND MODES, CONTINUED In this mode, the Open Light will be illuminated. The hand motor will respond to wrist extensor EMG signal. Open mode Actions: • When User relaxes wrist extensors, the fingers will close. • When User contracts wrist extensors, the fingers will open. In this mode, both the Close and Open Light will be illuminated.
  • Page 30 The elbow mode button cycles through the 4 modes, moving to the next mode each time you press the mode button. When the MARK device is turned ON, the elbow will be in Standby mode. Press the elbow mode button one time to put the elbow into Biceps mode...

  • Page 31: Orthosis Diagrams

    DIAGRAMS PN 26216 Rev 006...
  • Page 32 MARK ORTHOSIS DIAGRAM Harness Attachment Upper Cuff Points Closure Multi-Articulating Wrist (MAW), Rotational Ring Upper Upper Arm Sensor Cuff Shell Forearm Sensor Cuff Hand Motor Forearm Closure Battery Compartment Hand Carrier Forearm Elbow Motor Forearm Multi-Articulating Wrist Support Shell (MAW), Flexion Joint...
  • Page 33 FINGER SUPPORT DIAGRAM Hand Support Shell Latch Loop Anvil Stem Dorsal Finger Hand strap Piece Finger Saddle Pinchers Thumb Saddle PN 26216 Rev 006...
  • Page 34 TOOL KIT Large Hex Key 2.5 mm Philips Head Screwdriver Medium Hex Key 3/32 inch Flat Head (2.38 mm) Screwdriver Small Hex Key 2.0 mm PN 26216 Rev 006...

  • Page 35: Putting The Orthosis On A User ("Donning")

    PUTTING THE ORTHOSIS ON A USER (“DONNING”) PN 26216 Rev 006...
  • Page 36 User’s range of motion. WARNING: Do not allow the User to sleep while wearing the MARK device Do not allow the User to sleep while wearing the MARK device as the straps may alter the user’s circulation.
  • Page 37 NOTE ON SIZING The MARK devices and the additional size components of the kit are currently built to adjust to the following arm measurements: Measurement Min (inches) Max (inches) Forearm circumference Biceps circumference Upper arm length none Wrist thickness (Anterior-Posterior) None 2.25...

  • Page 38: Sensor Placement

    SENSOR PLACEMENT Sensors for the biceps and triceps muscles are built into the Upper Sensor Cuff. They are attached with Velcro so they can be repositioned, but will stay in place for the User. The Velcro is color coded. Generally, optimal sensor place will be on the muscle belly.
  • Page 39 STEPS FOR PUTTING THE ORTHOSIS ON 1. POWER OFF: The device should remain turned OFF until it is fully on the arm and adjusted to the User. Check that it is OFF before starting this process. NOTE: Pads and straps should be fully air-dried from the previous use. ▲...
  • Page 40 STEPS FOR PUTTING THE ORTHOSIS ON, CONTINUED 8. UPPER ARM: Wrap the Upper Sensor Cuff around the User’s upper arm, keeping attention on the Biceps and Triceps sensors; when the Upper Sensor Cuff is properly fit, the sensors should be centered over the biceps and triceps muscles.
  • Page 41 STEPS FOR PUTTING THE ORTHOSIS ON, CONTINUED 9. FOREARM SENSOR: Slide the Forearm Sensor Cuff onto the forearm. Tuck the Forearm Sensor Cuff’s Velcro strap under the forearm bar and secure the Velcro. NOTE: The sensor with the GREEN Velcro goes on the inner side of the forearm (aligned with the palm), and the sensor with the YELLOW Velcro goes on the outer side of the forearm...
  • Page 42 STEPS FOR PUTTING THE ORTHOSIS ON, CONTINUED FINGER SUPPORT Start with the finger support Work the Finger Saddle under your fingers while detached from the Anvil. holding the Stem and Loop. If helpful, you can also push Line up the loop over the Lift up on the Stem or down on the back of the anvil.
  • Page 43 MyoPro 2 Prehensile Pinchers Prehensile Pinchers are provided with each MyoPro 2 to aid grasping light weight (under 1 lb) objects. Use of the Prehensile Pinchers is optional (not required) and they may be attached or removed as desired. NOTE: if used, it is recommended to limit use for therapy sessions and then remove for routine daily activities. Please note the angle between the thumb and index finger may require adjustment to ensure contact between the Prehensile Pinchers.
  • Page 44 Align the Dorsal Prehensile Pincher with the Dorsal Finger Piece. Ensure the holes of each align. If the surfaces of the Prehensile Pincher and Dorsal Finger Piece do not align, try the other Prehensile Pincher. Insert the provided Thumb Screw into the aligned holes. Turn clockwise to tighten until secure. Repeat steps for the Palmar Prehensile Pinchers.
  • Page 45 Prehensile Pinchers may be stored in the MyoPro carrying case. Upon removal, the Prehensile Pinchers should be inspected for wear and tear, fatigue cracking, and damage. Contract Myomo Customer Support for replacement if needed as they are a serviceable item. ▲...
  • Page 46 PN 26216 Rev 006...

  • Page 47: Harness

    HARNESS PN 26216 Rev 006...
  • Page 48 HARNESS DIAGRAM Anterior Fine- Adjustment Closure (Velcros to the Chest Strap) Chest Strap Axilla Pad Main Adjustment Quick Closure Release Tab (loops through the plastic ring attached to the shoulder saddle and Velcros to the Chest Strap) Anterior Shoulder Suspension Saddle Extra Strap...
  • Page 49 Suspension Straps: • Off-load the weight of the MARK device and the User’s arm by abducting the User’s arm for them while tightening the suspension straps. This will ensure that the straps distribute the full weight of the device to the Shoulder Pad and Check strap, and ensure that the device will not migrate down the arm during use.
  • Page 50 STEPS FOR PUTTING THE HARNESS ON The Anti-Rotation Strap (A-R strap) is added if shoulder tone, weakness, or instability prevents a patient from being able to externally rotate their arm away from their chest. 1. Locate the D-rings on the humeral shell which are used for the harness. The anterior attachment point has two D-rings.

  • Page 51: Hand Adjustments

    HAND ADJUSTMENTS PN 26216 Rev 006...
  • Page 52 HAND SUPPORT SHELL PAD With Pad Without Pad The Kit includes an additional pad for the hand shell. This pad can fill up extra space and allow better fit for smaller patients for whom the Hand Support Shell may be oversized. PN 26216 Rev 006...
  • Page 53 HAND SUPPORT SHELL POSITION Be sure the hand is all the way into the supporting plastic around the palm. The web-space of the thumb should be flush with the plastic. Check Forearm Bar Length (see page 59) ADJUST Check MAW: Proximal/Distal Position (see page 53) Check Elbow Center Alignment (see page 62) INCORRECT CORRECT...
  • Page 54 THUMB SADDLE SIZE There are two sizes of Thumb Saddle; use the Philips Head screwdriver to ADJUST interchange them. Shorter Longer The saddle is more proximal The saddle is more distal PN 26216 Rev 006...
  • Page 55 THUMB ANGLE The User’s thumb and finger tips should be positioned however it is most comfortable for the User. Some Users may prefer to have their thumb and finger tips touch; others may prefer a wider grip. The thumb linkage can pivot in the channel by the MCP joint. Use the Phillips Head screwdriver to loosen the more proximal of the two ADJUST screws which hold the thumb onto the hand support shell, then pivot...
  • Page 56 FINGER SADDLE POSITION INCORRECT CORRECT Too far forward (fingers slipping out) Comfortable joint support The Finger Saddle can slide back and forth along the Stem for proper placement and mobility through the Users range of motion. PN 26216 Rev 006...
  • Page 57 PREHENSILE PINCHERS Thumbscrews For certain tasks, some Users may find additional dexterity with the Prehensile Pincher attachments. Others may prefer to have these removed. They attach and reattach easily with thumbscrews. PN 26216 Rev 006...
  • Page 58 PN 26216 Rev 006...

  • Page 59: Wrist Adjustments

    WRIST ADJUSTMENTS PN 26216 Rev 006...
  • Page 60 MAW: PROXIMAL/DISTAL POSITION The MAW position along the User’s forearm (proximal-distal) can be adjusted by changing the length of the forearm bar. If additional position adjustment is needed, you can slide the MAW along this section of the forearm bar by loosening and retightening this screw with the small hex key (2.0 mm). PN 26216 Rev 006...
  • Page 61 MAW: PRONATION/SUPINATION RESISTANCE Using the flat head screwdriver, LIGHTLY tighten or loosen the screw to increase ADJUST or decrease the tension for pronation and supination. NOTES: A. Only turn the screw one half turn at a time. It takes minimal adjustment to change the tension. B.
  • Page 62 MAW: FLEXION/EXTENSION RESISTANCE Use the large hex key (2.5 mm) to tighten or loosen the screw by the ADJUST hand flexion joint. NOTES: A. Turn the screw one half turn at a time. It takes minimal adjustment to change the tension. B.
  • Page 63 HAND CARRIER BAR There are two lengths of hand carrier bar: one longer, and one shorter. Use the Philips Head screwdriver to detach and reattach as shown with the components below. This end attaches to the Hand Support Shell This end attaches to the Wrist Flexion Joint...
  • Page 64 PN 26216 Rev 006...

  • Page 65: Forearm Adjustments

    FOREARM ADJUSTMENTS PN 26216 Rev 006...
  • Page 66 FOREARM SUPPORT SHELL PAD The forearm pad can be removed for laundering. Two pads are included with each device, one slightly thicker than the other. PN 26216 Rev 006...
  • Page 67 FOREARM BAR LENGTH The Forearm Bar lengthens or retracts by loosening the thumb screw. Tighten the screw to hold the bar at a set distance. PN 26216 Rev 006...
  • Page 68 FOREARM SUPPORT SHELL POSITION The Forearm Support Shell slides up and down the Forearm Bar for optimal positioning. PN 26216 Rev 006...

  • Page 69: Upper Arm Adjustments

    UPPER ARM ADJUSTMENTS PN 26216 Rev 006...
  • Page 70 ELBOW CENTER ALIGNMENT • Align the point of elbow rotation of the device with the User’s elbow center. • Double check by passively flexing and extending the User’s arm in the device while the device is turned OFF. • Ensure that the harness is supporting the full weight of the device, and the straps are tight, so that the device does not slide down the User’s arm.
  • Page 71 UPPER SENSOR CUFF & CLOSURE ADJUSTMENTS The Upper Cuff Closure attachment point can be moved up or down on the lateral side, using the Philips Head screwdriver. Outside Inside The Upper Sensor Cuff can be moved up or down inside the Upper Arm Shell using the Philips Head screwdriver.
  • Page 72 PN 26216 Rev 006...

  • Page 73: Check The Fit

    CHECK THE FIT PN 26216 Rev 006...
  • Page 74 CHECKING THE FIT • Passively (and slowly) open and close the fingers; ensure that knuckles are not rubbing on the plastic edges of hand or finger supports. • Passively flex and extend the wrist to check alignment; wrist should not hit hand plastic or MAW. •...

  • Page 75: Taking The Orthosis Off Of A User ("Doffing")

    TAKING THE ORTHOSIS OFF OF A USER (“DOFFING”) PN 26216 Rev 006...
  • Page 76 STEPS FOR TAKING THE ORTHOSIS OFF WARNINGS REVIEW WARNING: If at any time during the use of this device, you notices any of the following, discontinue use and contact Myomo Support. • Movement does not match the User’s desired motion.

  • Page 77: Maintenance & Troubleshooting

    MAINTENANCE & TROUBLESHOOTING PN 26216 Rev 006...
  • Page 78 SIZE ADJUSTABLE COMPONENTS Size 1 Component (comes build onto Size 2 the orthosis) Hand Carrier Bar Shorter Longer Forearm Pad Thicker Thinner Thumb Saddle Shorter Longer PN 26216 Rev 006...
  • Page 79 EXTRA PARTS Component Used For… An extra finger Loop with Finger Finger Support Saddle (one size) Extra hold on any screws that are NOT part of the Hand Carrier Bar Lock Washers attachment to the Hand Support Shell (this is supposed to rotate) Black Philips head screw Thumb Saddle Weld nut...
  • Page 80 MARK device is allowed as it may expose other dangers. To ensure absolute safety of device and personnel, only Myomo staff may address repairs to the mechanical or electrical components of the device. If such a repair is needed, contact Myomo support. The estimated turnaround time for repairs of this nature is 1-2 weeks.
  • Page 81 It is best to store the battery with a state of charge between 50-80%, particularly for longer term storage. WARNING: If storing the MARK for more than one month, remove the battery from the battery compartment. NOTE: Even if it is in storage, the battery should be recharged every 6 months.
  • Page 82 AVOIDING DAMAGE TO THE MARK The MARK device is designed to facilitate voluntary movements. It can be damaged by excessive force, either from a User forcibly moving the motor too hard, or if something (such as the arm of a chair) restricts the device’s movement as it is trying to assist the User.

  • Page 83: Troubleshooting

    TROUBLESHOOTING BEST PRACTICES FOR SMOOTH PERFORMANCE Several factors can result in erratic movement of the orthosis. NOTE: The metal components of each sensor must have contact with the User’s skin in order to properly read EMG signal. FACTOR A: STRAP TENSION Make sure the Upper Sensor Cuff and Upper Cuff Closure are comfortably snug –...

  • Page 84: Troubleshooting Tips

    TROUBLESHOOTING TROUBLESHOOTING TIPS For additional clinical or technical questions or issues relating to the device, contact Myomo. See Page 2 for contact information. SYMPTOM POSSIBLE CAUSE SOLUTION Inappropriate sensitivity settings Adjust sensitivity settings Check that cuffs and closures are snug,...
  • Page 85 User, and contact Myomo support. RECOGNIZING WHEN THE MARK IS EXPERIENCING AN ERROR When the MARK device detects and error and initiates and error code, it will not function normally. An electrical or mechanical failure is indicated by the following: The Bluetooth light will be flashing (blinking).
  • Page 86 LOCATION OF IDENTIFYING NUMBERS Elbow Motor Unit The primary identifying number for each individual MARK device is located on the back of the battery and electronics case: it is the serial number for the elbow motor. It is written as “M000” followed by a 3 or 4 digit number.

  • Page 87: Technical Specifications & Markings

    TECHNICAL SPECIFICATIONS & MARKINGS PN 26216 Rev 006...

  • Page 88: Technical Specifications

    TECHNICAL SPECIFICATIONS WARNING: The MARK is not suitable for use in the presence of flammable anesthetic mixtures with air, or flammable anesthetic mixtures with oxygen or nitrous oxide. ENVIRONMENTAL REQUIREMENTS MARK Device Temperature Operating: 0 to 40 °C (32 to 104 °F) Storing: -10 to 60 °C (14 to 140 °F)
  • Page 89 Only Myomo personnel may inspect or repair mechanical or electrical components of the MARK in order to maintain basic safety and essential performance with regard to electromagnetic disturbances. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
  • Page 90 ON-DEVICE MARKINGS Symbol Description Attention – Refer to the accompanying instructions Power “On/Off” (push-push) IEC 60417-5010 The product should be disposed of according to local guidelines Complies with FCC Part B Standards- Medical Equipment Safety Tested to 60601-1 3rd Edition as amended 1 and 60601-1-2 electromagnetic disturbances.

  • Page 91: Additional Information

    Ingress Protection rating 21 40C° Operating Temperature Range: 0 to 40 °C (32 to 104 °F) 0C° Operating Humidity Range: 10% to 90% non-condensing 1060 hPa Operating Atmospheric Pressure Range:700 hPa to 1060 hPa 700 hPa Manufacturer: Myomo Inc. PN 26216 Rev 006...
  • Page 92 BATTERY AND CHARGER MARKINGS Symbol Description General warning sign Instructions for use For indoor use only The battery and battery charger comply to the current regulations of the EU guidelines The battery complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Table of Contents