biomotum SPARK Bedienungsanleitung
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):
(800) 566-2531
Caution: Investigational device. Limited by Federal law to investigational use.
www.biomotum.com
REC-184 Version 0 Page 1 of 39
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION 3
INDICATIONS FOR USE 3
CONTRAINDICATIONS FOR USE 3
DEVICE DESCRIPTION 3
OPERATING PRINCIPLE 5
SYSTEM CALIBRATION 7
NOTATIONS USED 7
SYMBOLS USED 8
WARNINGS & CAUTIONS: 8
CHAPTER 2:PREPARE THE SPARK FOR USE 10
SAFETY CHECK PROCEDURES 10
BATTERY USE 10
CHOOSING FOOTPLATE SIZE 12
ATTACHING/REMOVING THE FOOTPLATE 13
ATTACHING AND ADJUSTING THE CALF CUFF 14
CHAPTER 3: DONNING THE SPARK 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 FEATURES 29
SESSION SUMMARY OVERVIEW 32
CHAPTER 5: ERROR MESSAGES, TROUBLESHOOTING 33
DEVICE SETUP 33
WALKING 34
SOFTWARE 35
CHAPTER 6: CLEANING & MAINTENANCE 37
CLEANING 37
MAINTENANCE 37
www.biomotum.com
REC-184 Version 0 Page 2 of 39
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
●Cable Transmission: The cables transfer torque from the motors to the
ankle actuator. The cable transmission system is worn using thigh straps to
prevent the cables from catching on the environment.
●Ankle Actuator: The ankle actuator is a lightweight, single
degree-of-freedom rotational joint that interfaces with the wearer’s shank
and foot to transfer torque from the motors to the wearer’s ankle joint. The
ankle actuator is held on the shank using a comfortable shank cuff. A
footplate attached to the ankle actuator fits in the wearer’s shoe and
moves the foot to provide assistance or resistance to the wearer’s ankle
joint. Shank cuffs and footplates are interchangeable and must be fitted to
the wearer so that they are snug yet comfortable. Sensors in the ankle
actuator measure the torque transmitted by the device; sensors on the
footplate detect whether the wearer’s foot is in contact with the ground.
Both sensors are integral to the function of the device and must be
handled with care.
●Control Interface: The control interface is an iOS/Android tablet preloaded
with a proprietary 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 meters) of the device at
all times to maintain Bluetooth connection. The device will continue to
function when disconnected, but the device settings cannot be changed,
sessions and trials cannot be ended, and data collected while the control
interface is disconnected will not be stored or saved. 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:
●2.5mm hex screwdriver, used on the safety bolt for the metal
quick-connect bracket on the footplate
●1.8mm slotted screwdriver, used on the screw for the cuff quick-release
mechanism
Materials needed but not provided:
Plastic card, key, or slot-head screwdriver, to check the tension in the actuator
cables.
www.biomotum.com
REC-184 Version 0 Page 5 of 39
An illustration of the Biomotum SPARK device is included below.
Figure 1. Biomotum Spark System Components
OPERATING PRINCIPLE
SPARK’s hybrid control system adjusts assistance or resistance across variable
terrain and walking speeds. Hybrid control uses force sensors embedded into
each footplate and provides torque that is proportional to the instantaneous
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
automatically adjusted proportional to the change in foot sensor measurement
and peak torque setting, in real time.
www.biomotum.com
REC-184 Version 0 Page 6 of 39
Hybrid control: Assist to make walking easier.
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.
Ranges for optimal peak stance phase plantarflexor 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 therapist at their
discretion after assessing the user’s gait pattern. Nominal, on-off dorsiflexor
torque can be provided during the swing phase between 0-5 Nm.
SYSTEM CALIBRATION
www.biomotum.com
REC-184 Version 0 Page 7 of 39
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.
The dynamic calibration begins after the user starts walking during a trial.
Dynamic calibration quantifies the pressure threshold used to determine the
stance and swing phases by logging the maximum and minimum pressure
sensor signal for each step taken. The dynamic calibration also quantifies the
baseline peak pressure (average peak pressure during the initial steps).
The prescribed torque profile is generated by taking the instantaneous pressure
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 torque is not applied until the dynamic calibration is complete
and the pressure sensor baseline is established.
NOTATIONS USED
Warnings & Cautions used throughout this manual:
WARNING: Describes potential safety hazards, limitations in use as a result of the
potential safety hazard, and steps that should be taken if a safety hazard occurs.
Caution: Information about any special care to be used for the safe and effective
use of the device. Not following this information could lead to damage of the
device or lead to a poor participant experience.
Note: Information that’s helpful to use the device correctly.
www.biomotum.com
REC-184 Version 0 Page 8 of 39
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.
The risk of falling can be reduced by having experienced, trained personnel
conduct the therapy sessions using manual assistance. If needed, 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 the skin at
points of contact (waist, shoulders, thighs, calves and feet) during each session.
Adjustments to the device fit and additional padding can be used to decrease the
risk of skin breakdown.
www.biomotum.com
REC-184 Version 0 Page 9 of 39
WARNING: The SPARK may cause an individual to exceed their ankle joint range
of motion, potentially leading to a tendon strain, muscle tear, or avulsion. This risk
is reduced by mechanical stops on the SPARK that prevent the device from
exceeding the normal ankle joint range of motion in the event of an electrical or
software malfunction. Software systems are also in place to further reduce range
of motion to improve fit and comfort during walking. The SPARK should only be
used on individuals who have sufficient ankle joint range of motion (see
Contraindications).
WARNING: Use of the SPARK may cause muscle spasms in participants with
hypertonicity or tight/stiff muscles. Such 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 activities.
Caution: Ensure the battery is inserted firmly into the waist pack so that no silver
label (other than the pull tab) is showing.
Caution: Do not discharge the battery completely (<15%).
Caution: Make sure the upright & calf cuff are behind the shank and not off to the
side when fitting the device.
Caution: Ensure the purple cables are not twisted when fitting the device.
Twisted cables can negatively affect device performance.
www.biomotum.com
REC-184 Version 0 Page 10 of 39
Inhaltsverzeichnis
Beliebte Robotik Handbücher anderer Marken
STEMCenter USA
STEMCenter USA Pi-Bot v2.00 Bedienungsanleitung
SunFounder
SunFounder PiDog Bedienungsanleitung
Universal Robots
Universal Robots UR5 Bedienungsanleitung
Universal Robots
Universal Robots E Series Bedienungsanleitung
YASKAWA
YASKAWA MOTOMAN-MPL80 II Bedienungsanleitung
EFORT
EFORT ECR5 Gebrauchsanweisung
