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USER MANUAL
Biomotum SPARK
This user manual is provided as a comprehensive guide and reference for using
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
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Table of Contents
Summary of Contents for biomotum SPARK
- Page 1 Biomotum SPARK This user manual is provided as a comprehensive guide and reference for using 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.
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Page 2: Table Of Contents
DEVICE DESCRIPTION OPERATING PRINCIPLE SYSTEM CALIBRATION NOTATIONS USED SYMBOLS USED WARNINGS & CAUTIONS: CHAPTER 2: PREPARE THE SPARK FOR USE SAFETY CHECK PROCEDURES BATTERY USE CHOOSING FOOTPLATE SIZE ATTACHING/REMOVING THE FOOTPLATE ATTACHING AND ADJUSTING THE CALF CUFF CHAPTER 3: DONNING THE SPARK... - Page 3 REC-184 Version 0 Page 3 of 39...
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Page 4: Chapter 1: Introduction
. 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. - Page 5 Normal operations will resume once the device is within range of the control interface. The Investigational Use SPARK device includes an iOS tablet pre-loaded with the Biomotum application (app). The SPARK device is also provided with the following tools: ●...
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Page 6: Operating Principle
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... -
Page 7: System Calibration
Resist for precision ankle therapy Figure 2. SPARK Control System The SPARK has two modes of operation (“hybrid control”): ● Assistance: Assistance mode provides ankle joint plantarflexion torque during stance and dorsiflexion torque during swing. ● Resistance: Resistance mode provides ankle joint dorsiflexion torque during stance. -
Page 8: Notations Used
The SPARK performs both a static and dynamic calibration each time the SPARK is donned and used. The static calibration is performed while the user is standing still, after donning the SPARK. Device torque is measured by the torque sensors in each ankle actuator, and is tared during the static calibration to eliminate bias in the measured torque signal that can affect control of the SPARK system. -
Page 9: Symbols Used
SYMBOLS USED WARNINGS & CAUTIONS: WARNING: The SPARK is not waterproof. Do not use it if there is a risk of the device being exposed to water or other liquids. WARNING: Risk of falling. Falling could be caused by a loss of control of ambulation by the participant or therapist as well as malfunction of the SPARK. - Page 10 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.
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Page 11: Chapter 2: Prepare The Spark For Use
● Ensure the footplate is securely attached to the ankle actuator and 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. - Page 12 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.
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Page 13: Choosing Footplate Size
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 the user. www.biomotum.com REC-184 Version 0 Page 13 of 39... -
Page 14: Attaching/Removing The Footplate
NOTE: Avoid using oversized shoes as the foot and footplate will move within the shoe and affect the quality of exoskeleton assistance or resistance. NOTE: The SPARK is designed for use with low-top footwear and will not work with high-top styles that go above the ankle. -
Page 15: Attaching And Adjusting The Calf Cuff
The right cuff size is too large for the user and the user has excess space between the side of the user’s leg and the cuff. www.biomotum.com REC-184 Version 0... - Page 16 If the cuff moves with the quick-release lever secured, refer to the Troubleshooting Guide. NOTE: Calf cuff height adjustment can also be done when donning the SPARK (after the footplate is in the shoe and the foot is inserted).
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Page 17: Chapter 3: Donning The Spark
Figure 9. Calf cuff aligned with the largest part of the calf musculature CHAPTER 3: DONNING THE SPARK The SPARK is designed to contact the participant at the foot, lower leg, and around the waist. Avoid direct contact of the device with the skin by using the system with socks and pants. -
Page 18: Putting On The Ankle/Foot Assembly
The calf cuff should be snug. ● Confirm that the ankle/foot assembly is comfortable and the participant can plantarflex and dorsiflex the ankle. ● Repeat with the other foot. www.biomotum.com REC-184 Version 0 Page 18 of 39... -
Page 19: Donning The Waist Pack
● While the participant is standing, check the tension in the actuator cables by inserting a rigid object (e.g., key, plastic card, small flathead screwdriver or similar) in the slot near the top of the pulley covers. www.biomotum.com REC-184 Version 0 Page 19 of 39... -
Page 20: Securing The Thigh Straps
● Connect the thigh straps to the purple cables by opening up the Velcro on each thigh strap (left image) and enclosing the cables securely (right image), repeat for both legs. (Figure 13) www.biomotum.com REC-184 Version 0 Page 20 of 39... - Page 21 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...
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Page 22: Using The Shoulder Harness (Optional)
● Place the participant’s foot on the footplate and attach the elastic loop fastener to the hook fasteners on the bottom of the footplate. NOTE: Useful wrapping techniques are shown in Figures 15 and 16. www.biomotum.com REC-184 Version 0 Page 22 of 39... -
Page 23: System Check
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. -
Page 24: Chapter 4: Settings, Calibrations And Use
CHAPTER 4: SETTINGS, CALIBRATIONS AND USE TURNING ON AND PAIRING THE SPARK ● The power button for the SPARK is located on the bottom of the waist pack (Figure 17). Turn on the SPARK by toggling the switch to the ON position. -
Page 25: Input User Settings
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 are participant visits (i.e., intervention sessions) and trials are the individual walking trials completed during a visit/session. - Page 26 Enter the Study/Clinic Name, the Participant’s ID#, and weight (lbs). These fields are required. b. Once user data is saved, press “Start New Session”. See Input Walking Settings (below) for next steps. www.biomotum.com REC-184 Version 0 Page 26 of 39...
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Page 27: Input Walking Settings
See Input Walking Settings (below) for next steps. INPUT 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). - Page 28 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.
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Page 29: Calibrating The System
Static Calibration: Once the device is on the participant and the device settings have been entered, have the participant stand still. Select the calibration button at the bottom of the New Session screen. The SPARK will conduct a quick (<1 second) static calibration. - Page 30 Select Begin Session to start a trial. Dynamic Calibration: Once a participant begins walking, it takes about 7 steps before the SPARK produces torque. During 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.
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Page 31: Using In-Trial Features
If it seems difficult for the participant to exceed the threshold, you can press retake baseline to ensure the baseline values are appropriate. If it’s still difficult for the participant to exceed the threshold, reducing the threshold value may be necessary. www.biomotum.com REC-184 Version 0 Page 31 of 39... - Page 32 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-184 Version 0 Page 32 of 39...
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Page 33: Session Summary Overview
Moving two fingers away from each other will zoom in on the charts. This page can be closed by selecting New Trial or End Session. Figure 26. Session summary overview www.biomotum.com REC-184 Version 0 Page 33 of 39... -
Page 34: Chapter 5: Error Messages, Troubleshooting
CHAPTER 5: ERROR MESSAGES, TROUBLESHOOTING This chapter describes issues that occur while using the SPARK app and actions to take to resolve the issue. DEVICE SETUP BEHAVIOR POSSIBLE REASONS SOLUTION Footplate does not lock into Footplate is on the Check footplate and device place wrong side. -
Page 35: Walking
User feels like torque is applied when no torque was prescribed. An issue (e.g., mis-step) Recalibrate baseline. Did it occurred during the improve? If not, see below. walking calibration. www.biomotum.com REC-184 Version 0 Page 35 of 39... -
Page 36: Software
Application slowing down. Bluetooth error. Close the app, power off the SPARK device. Then power the SPARK on and open the app.. Try connecting to the device again. Make sure you fully quit the application by double clicking the iPad home button and swiping up on the application. - Page 37 Device is connected to If you have multiple software another application. devices to control the SPARK, ensure all applications are closed. If the SPARK LED light is purple, it is already connected to another device. Application has Force quit the application. To crashed.
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Page 38: Chapter 6: Cleaning & Maintenance
MAINTENANCE Complete the following maintenance/service checks at the indicated times. Consult the User Manual for detailed instructions. Contact Biomotum if clarification is needed. Biomotum will alert each customer by phone or email when each step-count milestone has been reached. Milestone/Frequency... - Page 39 first · Visually check system for signs of excessive wear 100,000 steps or after · Conduct video chat with Biomotum engineering team; schedule first 100 sessions, via website Contact Us link whichever comes first · Check cable tension ·...
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