MyndStep 800102 User manual

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TABLE OF CONTENTS
Foreword ...................................................................................................................................................2
Working Principle ......................................................................................................................................3
Clinical Instructions ...................................................................................................................................5
Safety Instructions.....................................................................................................................................8
EMC Guidance ........................................................................................................................................21
Inspection of the Goods ..........................................................................................................................29
Overview of the Unit ................................................................................................................................31
MyndStep Application..............................................................................................................................36
Operation Guidance ................................................................................................................................61
Care and Maintenance ............................................................................................................................69
Troubleshooting.......................................................................................................................................73
Technical Specifications ..........................................................................................................................76
Assistance ...............................................................................................................................................80
Warranty..................................................................................................................................................81

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Foreword
Thank you for purchasing the MyndStep Foot Drop System from MyndTec.
This manual is intended for the owners and operators of MyndStep. It contains general information
on the instructions for safety, intended use, working principle, operation, maintenance, troubleshooting,
and warranty. In order to maximize the use, efficiency, and working life of your unit, please read this
manual thoroughly and become familiar with the controls, as well as the accessories, before operating
the unit.
Specifications put forward in this manual were effective at the time of publication. However, owing to
the continually improving policy of MyndTec Inc., any changes to these specifications may be made at
any time without obligation on the part of MyndTec Inc.
Before administering any treatment to a patient, the user of this equipment should read, understand,
and follow the information contained in this manual for each mode of treatment available, as well as the
indications, contraindications, warnings, and precautions.

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Product Description
MyndStep is a functional electrical stimulation (FES) system indicated for the treatment of foot drop
as a consequence of upper motor neuron (UMN) injury to include and not limited to:
•Stroke
•Spinal Cord Injury (SCI)
•Traumatic Brain Injury (TBI)
•Multiple Sclerosis (MS)
•Cerebral Palsy (CP)
The MyndStep system uses an accelerometer and an inclinometer to signal stimulation of the
common peroneal nerve which stimulates the anterior tibialis muscle. The motor output – ankle
dorsiflexion - will lift the foot to clear the ground’s surface during ambulation; and, manage a step, curb,
doorsill and stairs.
Working Principle

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AC Input
Processor
PWM Intensity
Adjustment
Pulse
Generating Electrode
Current
Feedback
Communication of
Mobile Phone APP
and Bluetooth
Bluetooth
Chip
Battery
Power
Adapter
Button

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Clinical Instructions
A correct examination and diagnosis should be performed before treatment with MyndStep.
Indications for Use
MyndStep is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a
consequence of upper motor neuron injury. Detect the swing phase of gait and appropriate electrical
stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or
impaired function.
Contraindications
1) Do not use it on persons with implanted demand-type cardiac pacemakers or defibrillators.
2) Do not use it on persons with severe heart failure or arrhythmia.
3) Do not use on persons with histories of seizure disorder.
4) Do not use it on persons in the acute or critical stage of important organ disease.

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5) Do not use it on persons who cannot provide sensory feedback for stimulation (unable to express or
have difficulty in the communication), such as mental disease.
6) Do not place the electrodes on the carotid sinus region.
7) Do not place the electrodes over the eyes, pregnant women's waist or abdomen or other specific
areas.
8) Do not use it on persons whose treatment area with bleeding tendency, metal matter or tuberculous
lesions.
9) Do not place the electrodes over areas in which symptoms of existing thrombosis or thrombophlebitis
are present.
10) Do not place the electrodes over areas with acute suppurative inflammation symptoms.
11) Do not place the electrodes over areas of skin allergy, infection, rash, wound or scars.
12) Do not place the electrodes over malignant tumors.
13) Do not place the electrodes over areas of fracture or dislocation.
14) Other specific conditions or diseases that doctors deem at risk.
Adverse Effects

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You should stop using the device and consult your doctor if you experience adverse reactions to the
device. Possible adverse reactions may include the following:
⚫skin irritation beneath the electrodes;
⚫burns beneath the electrodes;
⚫headaches or other painful sensations.

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Safety Instructions
Symbols
1. Medical Device Symbols
Symbols
Explanation
Manufacturer
Date of Manufacture
Proper waste disposal for electrical and electronic equipment (WEEE)
(See disposal for instructions.)
Type BF Applied Part(s)