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CHAPTER 1: INTRODUCTION

Caution

: Investigational device. Limited by Federal law to investigational use.

INDICATIONS FOR USE

The Biomotum SPARK orthotically fits the lower limbs and trunk.  The SPARK is
intended for use in rehabilitation institutions under the supervision of a trained
healthcare professional to assist ambulatory functions, and to temporarily help
improve ambulation upon completion of a gait training intervention.  The device
is intended for adolescents with Cerebral Palsy (ages between 12-21 years old) who
are able to walk for 6 minutes with or without a walking aid (e.g., AFO and/or
walker), and who do not have a musculoskeletal condition that would prevent the
safe use of ankle assistance or resistance .

The Biomotum SPARK is not intended to be used on participants under 12 years
old or over 21 years old; it has not been tested in these populations.

The Biomotum SPARK is not intended to be used for running or other sport
activity.

The Biomotum SPARK is not intended to be used in individuals with hypertonicity
or stiff muscles

.

CONTRAINDICATIONS FOR USE

●

Musculoskeletal conditions that would prevent the safe use of ankle
assistance or resistance, including:

○

<20 degrees of passive ankle plantarflexion range of motion

○

Knee extension or ankle dorsiflexion contractures >15 degrees

●

Orthopedic surgery on foot, ankle, or leg completed in the prior 6-months

●

Diagnosis of severe osteoporosis (low bone density)

●

Body mass index <5th percentile or >95th percentile

●

Cardiovascular disease that prevents mild-moderate physical activity

DEVICE DESCRIPTION

The Biomotum SPARK consists of the following components:

●

Waist Pack

: The waist pack houses the

motors

,

battery

, and

control

hardware

(motor drivers, microcontroller, Bluetooth hardware, and

measurement hardware) and is worn using  a comfortable

belt and

harness

with magnetic clasps. The

power button

to turn the device on and

off is located on the bottom of the waist pack.

www.biomotum.com

REC-184  Version 0

Page 4 of 39

Summary of Contents for SPARK

Page 1: ...g the Biomotum SPARK System If you need further assistance please contact the Biomotum clinical technical support team M F 8 am 4 pm Pacific Time support biomotum com 800 566 2531 Caution Investigational device Limited by Federal law to investigational use www biomotum com REC 184 Version 0 Page 1 of 39 ...

Page 2: ...16 PUTTING ON THE ANKLE FOOT ASSEMBLY 17 DONNING THE WAIST PACK 18 TENSIONING THE ACTUATOR CABLES 18 SECURING THE THIGH STRAPS 19 USING THE SHOULDER HARNESS OPTIONAL 21 USING THE FOOTPLATE STRAPS OPTIONAL 21 SYSTEM CHECK 22 CHAPTER 4 SETTINGS CALIBRATIONS AND USE 23 TURNING ON AND PAIRING THE SPARK 23 INPUT USER SETTINGS 24 INPUT WALKING SETTINGS 26 CALIBRATING THE SYSTEM 28 USING IN TRIAL FEATURE...

Page 3: ...www biomotum com REC 184 Version 0 Page 3 of 39 ...

Page 4: ... is not intended to be used for running or other sport activity The Biomotum SPARK is not intended to be used in individuals with hypertonicity or stiff muscles CONTRAINDICATIONS FOR USE Musculoskeletal conditions that would prevent the safe use of ankle assistance or resistance including 20 degrees of passive ankle plantarflexion range of motion Knee extension or ankle dorsiflexion contractures 1...

Page 5: ... application that controls the device wirelessly over Bluetooth The application stores wearer information and data starts and stops device sessions and trials performs device calibration allows the clinician researcher to adjust device settings and uploads collected data to a cloud service The device cannot be used without the control interface The control interface must remain within 30 feet 9 me...

Page 6: ...taneous demand placed on the ankle joint i e the net moment generated by muscles and other biological tissues crossing a joint The peak maximum torque that can be applied by the SPARK is set by the user In simple terms walking faster or slower results in a greater or smaller registered foot sensor force The amount of assistance or resistance provided to the user by the SPARK device is automaticall...

Page 7: ... assistance and resistance levels 0 25 0 30 Nm kg for assistance and 0 10 0 15 Nm kg for resistance were established during clinical walking testing The default settings are 0 30 Nm kg and 0 12 Nm kg for assistance and resistance respectively For example peak default assistance torque for a participant with a body mass of 75 lbs 34 kg would be 8 5Nm These settings can be customized by the therapis...

Page 8: ...e sensor signal and normalizing it by the baseline peak pressure value The resulting normalized signal is bounded by values 0 and 1 5 with the value 1 0 corresponding to the peak torque setting For example if a value of 30 or 15 Nm is entered in the app the controller will specify a peak prescribed torque of 15 Nm when the normalized pressure sensor signal is equal to 1 0 Assistive resistive torqu...

Page 9: ...eded an overhead attachment with a safety harness and or gait belt can be used during treadmill or over ground walking If a participant falls the device automatically powers off WARNING Use of the SPARK may cause discomfort skin irritation bruising pain or unusual swelling which may lead to skin breakdown or abrasions This risk can be minimized by proper initial adjustment and regularly checking t...

Page 10: ...ch individuals should not use the SPARK see Contraindications WARNING Use of the SPARK could result in bone fractures in individuals with severe osteoporosis Individuals with this condition should not use the SPARK Caution Do not use the SPARK on children under 12 years or in adults over 21 years It has not been tested in these populations Caution Do not use the SPARK for running or other sport ac...

Page 11: ...nd there are no visible signs of cracking BATTERY USE The Biomotum SPARK uses rechargeable lithium ion batteries designed to last up to 45 minutes Follow the charging and use instructions below to optimize the performance and safety of the system Fully charge the battery prior to use To confirm if the battery is fully charged check the battery charge indicator The charge indicator displays 5 charg...

Page 12: ...the battery completely as this may damage the battery and cause it to fail prematurely Caution Do not discharge the battery completely 15 Ensure the SPARK is turned off when not in use as leaving it on will drain the battery NOTE To conserve the battery life during a session turn off the SPARK if an individual will not be using it for more than 5 minutes www biomotum com REC 184 Version 0 Page 12 ...

Page 13: ...re 5 The footplate should be about the length of the foot but it can be slightly smaller than the foot if between sizes Figure 4 Footplate sizing chart Figure 5 Footplate fitting guide where the pink lines indicate foot sensor placement with respect to the user s foot The left footplate size is too large for the user The middle footplate size fits the user The right footplate size is too small for...

Page 14: ...m hex screwdriver to unscrew the safety bolt from the metal quick connect bracket by rotating the screw counter clockwise 1 2 revolutions Figure 6 NOTE Do not remove the screw It only needs to be loosened to insert the footplate Align the footplate with the studs on the quick connect bracket then push the footplate onto the quick connect bracket it will lock in place using magnets NOTE If the foot...

Page 15: ...f Figure 7 NOTE If the participant is between sizes use a larger calf cuff and pad the inside of the cuff with foam to create a snug fit Figure 7 Calf Cuff fitting guide The left cuff size fits the user The middle cuff size is too small for the user and has excess space between the user s calf and the cuff The right cuff size is too large for the user and the user has excess space between the side...

Page 16: ...iding the calf cuff up or down to the appropriate height Figure 9 Tighten the quick release lever on the calf cuff to secure it in place Secure the purple cables by snapping them into the clips on both sides of the cuff bracket When the quick release lever on the cuff is secured the cuff should not slide up and down If the cuff moves with the quick release lever secured refer to the Troubleshootin...

Page 17: ...xcess material and bulky seams which may cause skin irritation To don the SPARK Have the participant sit in a chair The participant must not be wearing shoes Have the participant move forward and sit on the front edge of the chair Put the waist unit behind them on the chair but do not attach it to the waist yet Bring the cables and ankle foot assemblies around the waist so that they are beside eac...

Page 18: ...f applicable so that the foot is secure If the foot moves in the shoe after tying untie and tighten the laces and tie again Tighten the shoelaces as much as comfortably possible NOTE The sock liner can be placed over the footplate if there is enough room in the shoe to accommodate it It s better to have the shoe be snug than loose Move the calf cuff forward until it touches the back of the calf Ad...

Page 19: ...d and tighten the waist strap so that the waist pack is snug NOTE Raise or lower the waist pack so that the purble cables have just enough slack to allow the participant to move without the cables becoming fully extended and pulling on the waist pack Use the shoulder harness straps if necessary see page 22 for instructions TENSIONING THE ACTUATOR CABLES While the participant is standing check the ...

Page 20: ... adjusters are located at the top of the pulley covers Figure 12 NOTE To rotate pull up on the barrel adjusters so the extruded gear features clear the surface When you are done tensioning the system make sure the extruded gear features are properly meshed with the surface so the barrel adjusters cannot loosen To loosen the cables lift and tighten the barrel adjusters turning clockwise SECURING TH...

Page 21: ...sers thighs using magnetic latches The latches snap together when you bring both sides close to each other To release push both sides of the buckle toward each other using a sliding motion Figure 14 Figure 14 Operation of the thigh strap latches www biomotum com REC 184 Version 0 Page 21 of 39 ...

Page 22: ...ATE STRAPS OPTIONAL Use footplate straps during walking trials where the participant s foot needs to be secured to the footplate such as in resistance mode To use footplate straps follow the steps outlined below Attach the adhesive hook fastener dots provided with the device to the bottom side of the footplate as seen in Figures 15 and 16 NOTE There are only enough adhesive hook fasteners in the b...

Page 23: ...ositioning for Velcro hook tabs and 2 footplate straps LARGE Figure 16 Positioning for Velcro hook tabs and 1 footplate straps SMALL SYSTEM CHECK Now that the SPARK is on the participant have them move around and take a few steps to confirm that it is comfortable and does not interfere with movement www biomotum com REC 184 Version 0 Page 23 of 39 ...

Page 24: ...sition The LED light on the face of the waist unit will illuminate green Figure 17 Power button and LED Indicator Using the tablet provided with the SPARK ensure Bluetooth is on and open the Biomotum app The app will automatically pair with the SPARK and the LED on the waist unit will turn purple A Bluetooth icon in the upper right corner of the app will appear www biomotum com REC 184 Version 0 P...

Page 25: ... and re open the app in the correct sequence of actions BT pairing is done automatically there is nothing for the user to do to start BT pairing NOTE Ensure Bluetooth is enabled on the tablet being used to control the SPARK NOTE If the battery charge level is 50 charge the battery prior to use INPUT USER SETTINGS All user information and walking settings are entered using the Biomotum app Sessions...

Page 26: ...using two fingers to zoom in or out Press done when finished ii View Last Session Displays last session Press done when finished iii Start New Session Starts a new session checks Bluetooth connection See Input Walking Settings below for next steps iv Edit the participant data displayed by selecting the pencil icon in the upper right corner of the screen 2 Add New User Used to input participant inf...

Page 27: ...WALKING SETTINGS The SPARK settings for a walking session are entered from the New Session screen on the app This screen lets you select the peak torque settings Prior Default Custom or Advanced mode Assistance or Resistance and values as percentage of body mass or N m Figure 20 Input user settings Peak Torque Settings the maximum torque that will be delivered to the participant www biomotum com R...

Page 28: ...orque values you want the system to use Note Settings can be different for each leg Figure 21 Device peak torque input Peak Torque Inputs Left and Right These values are the peak torque that will be applied by the SPARK Torque inputs can only be entered if you select Custom or Advanced buttons above Custom Peak Torque Percentage of Body Weight Enter appropriate left and right peak stance torques 3...

Page 29: ...footplate The torque is directed in dorsiflexion during stance brings shank towards the foot In swing phase either dorsiflexion assistance to assist drop foot or no torque can be applied during Resistance mode Once Settings are selected start the trial by having the participant stand perfectly still and then press the calibration button while they remain standing still CALIBRATING THE SYSTEM Stati...

Page 30: ... those initial steps the system performs the dynamic calibration NOTE If a trial is paused the pause symbol is shown in the upper left corner of the image below the motors stop producing torque immediately Torque is applied once the Play button is pressed and the trial is resumed Figure 24 In Trial screen www biomotum com REC 184 Version 0 Page 30 of 39 ...

Page 31: ...being produced State Mode displays whether the leg is in stance or swing Biofeedback Selecting biofeedback will open a new window where you can set a biofeedback threshold e g percentage of body weight that the clinician wants the participant to achieve This can be set individually for the right and left leg This can be helpful to encourage push off during late stance Once a threshold has been set...

Page 32: ...igure 25 Change settings Recalibrate FSRS Baseline Pushing the Recalibrate FSRs Baseline button will reset the dynamic calibration of the fore foot sensors The fore foot sensor uses Force Sensitive Resistors FSRs to transition between gait phases and control stance phase torque output Keep in mind it will take several steps for the new dynamic calibration to be complete Torque www biomotum com REC...

Page 33: ...It also includes trial summary information If there was more than one trial in a session you can select which trial to review from the trial dropdown menu Trial data displayed includes duration number of steps mode i e assistance or resistance torque settings and charts displaying either the torque or state data depending on the selection Moving two fingers away from each other will zoom in on the...

Page 34: ...again Cuff slides freely on upright even though the quick release is engaged Cuff may be on the wrong side Check that the cuff is on the correct side of the device Cuffs are directional and have different sized sliders Cuff slider may be too loose If cuffs are on the correct side of the device in the correct orientation rotate the quick release handle clockwise 1 2 rotations Try attaching the cuff...

Page 35: ...Settings page If the device does not transition to stance phase quickly enough enter a lower e g 20 FSR threshold for the affected leg and click Send FSR Thresholds under the Change Settings page Device torque does not reach peak torque Desired torque is above the upper limit Recalibrate FSRs Baseline Plantarflexion dorsiflexion bias in zero torque control OR User feels like torque is applied when...

Page 36: ...ical Support for next steps Torque application is lagging Purple cables twisted Ensure the cables are not twisted around each other If cables are not twisted see below Cables are not adequately tensioned Check the cable tension and tension as required SOFTWARE BEHAVIOR POSSIBLE REASONS SOLUTION Application slowing down Out of date software Update application through the app store Device not connec...

Page 37: ...tap the home button and swipe up on the app Internet Connection Alert Not connected to WiFi Connect the device running the app to a WiFi network Make sure the WiFi network is connected to the internet Graph not plotting Poor Connection End the current session Turn off the SPARK device Close the mobile application Turn on the device Re open the application Application has crashed Turn off the SPARK...

Page 38: ...omotum will alert each customer by phone or email when each step count milestone has been reached Milestone Frequency Maintenance Description At the start of each use Check cable tension Visually check system for signs of excessive wear 25 000 steps or after first 25 sessions whichever comes first Check cable tension Check ankle bolts for loosening Balance battery per provided battery manufacturin...

Page 39: ...uct video chat with Biomotum engineering team schedule via website Contact Us link Check cable tension Check ankle bolts for loosening Balance battery per provided battery manufacturing instructions Gently clean ankle quick connect terminal pads with an alcohol swab Visually check system for signs of excessive wear 175 000 steps or after first 175 sessions whichever comes first Check cable tension...

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