●
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.
REC-184 Version 0
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