MyndStep 800102 User manual

1

1
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

2
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.

3
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

4
AC Input
Processor
PWM Intensity
Adjustment
Pulse
Generating Electrode
Current
Feedback
Communication of
Mobile Phone APP
and Bluetooth
Bluetooth
Chip
Battery
Power
Adapter
Button

5
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.

6
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

7
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.

8
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)

9
Protected against solid foreign objects of 12.5 mm (0.5 in) diameter and greater;
Protected against vertically falling water drops when the enclosure tilted up to 15°.
Caution: Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices to use or order the use of
the device.
This device emits non-ionizing radiation.
This symbol indicates that this device is a Class II equipment according to IEC
60601-1 (when charging).
Refer to the instruction manual/ booklet.
ON/OFF Button

10
2. Package Symbols
Symbols
Explanation
This Way Up
Fragile, handle with care
Keep Dry
Temperature Limitation: between -20°C and +55°C
Humidity Limitation: less than 93%
Atmospheric Pressure Limitation: between 86kPa and 106kPa

11
Precautionary Definitions
Specific symbols indicate the precautionary instructions in this section and throughout this manual.
Understand these symbols and their definitions before operating this equipment. The definitions of these
symbols are as follows:
Text with a “CAUTION” indicator will explain possible safety infractions that could potentially cause
minor to moderate injury or damage to equipment.
Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause
serious injury and equipment damage.
Refer to the Instruction Manual/Booklet

12
NOTE: Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid
in the particular area or function being described.
Type BF applied part (i.e. electrodes) complying with IEC 60601-1.
Warnings and Cautions
Please carefully read and understand the following warnings and cautions to ensure the safe and
correct use of MyndStep and prevent injury.
⚫Read, understand and practice the precautionary operating instructions. Know the limitations and
hazards associated with using MyndStep. Observe the precautionary and operational decals placed
on the unit.

13
⚫Before using MyndStep, make sure you have read and understood all information provided in this
manual. Familiarity with the information included in this manual is an essential requirement to ensure
efficient and optimal system use, avoid dangers to persons and the equipment, and obtain good
treatment results.
⚫Improper installation, operation, or maintenance of MyndStep may result in malfunctions of this unit
or other devices.
⚫Do not use when there is a mixture of the flammable anesthetic gas and air, a mixture of the
flammable anesthetic gas and oxygen or nitrous oxide.
⚫In case of device failure or other obvious defects, switch the unit off immediately and notify a certified
service technician.
⚫Adjustments or replacement of components may result in the equipment failing to meet the
requirements for interference suppression.
⚫The long-term effects of electrical stimulation are unknown.
⚫Do not apply stimulation over the carotid sinus nerves, particularly in patients with a known sensitivity
to the carotid sinus reflex.
⚫Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in the closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or
blood pressure.

14
⚫Do not apply stimulation over or in proximity to cancerous lesions.
⚫Do not apply stimulation across the patient’s chest because introducing an electrical current into the
chest may cause rhythm disturbances to the heart, which could be lethal.
⚫Since the effects of brain stimulation are unknown, stimulation should not be applied across the head,
and electrodes should not be placed on opposite sides of the head.
⚫Do not apply stimulation over swollen, red, or inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins).
⚫Do not apply stimulation when the patient is in the bath or shower.
⚫Do not apply stimulation while the patient is driving, operating machinery, or during any activity in
which electrical stimulation can put the patient at risk of injury.
⚫Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted
metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or
death.
⚫Do not use this unit for purposes other than treatment indicated in this manual.
⚫Do not use MyndStep with high-frequency surgical equipment on the patient. It will cause unstable
output when the unit is close to the high-frequency equipment (in the same room and without a
shield).
⚫Do not use this device simultaneously with other therapeutic devices (such as microwave or

15
shortwave) to avoid misoperation. Operation close (e.g. 1 m) to a shortwave or microwave therapy
device may produce instability in the device output.
⚫Output current density is related to electrode size. Improper application may result in patient injury.
Proceed systematically with caution when the current density is over 2 mA/ cm².
⚫Do not modify this device without the authorization of the manufacturer.
⚫MyndStep contains built-in batteries that the user cannot remove. Do not replace it by yourself to
avoid damaging the batteries or device. If necessary, please contact the company or the company
authorized maintenance personnel to replace them.
⚫Please dispose of the equipment and other accessories according to local regulations. Do not treat
them as household waste. Do not put the device in fire or water. If the batteries are not properly
disposed of, it may cause a battery explosion.
⚫Do not use the unit when it is charging.
⚫Always check the device and the electrodes for damage before use.
⚫If the unit is not functioning properly or you feel discomfort, immediately stop using the unit. If you
feel any trouble with your body or skin, consult the doctor and follow his/her instructions.
⚫The self-adhesive electrode is limited to the same person to use, do not use in other patients to

16
prevent infection.
⚫If the electrode loses viscosity, please replace the electrode in order to maintain good electrical
properties.
⚫The safety of electrical stimulation during pregnancy has not been established.
⚫Patients with suspected or diagnosed heart disease should follow precautions recommended by
their physicians.
⚫Use caution following recent surgical procedures when stimulation may disrupt the patient’s healing
process.
⚫Use caution if stimulation is applied over the uterus when menstruating.
⚫Use caution if stimulation is applied over areas of skin that lack normal sensation.
⚫Electrode placement and stimulation settings should be based on the guidance of the prescribing
practitioner.
⚫Keep this device out of the reach of children.
⚫Do not use this unit while sleeping. The main unit may develop trouble, or the pad may move to an
unexpected region and cause ill health.
⚫Clean the device using a soft dry cloth. Do not use cleaning solvents or other chemical substances
in order to avoid any damage.
⚫Make sure that you end the treatment by switching off the unit or by setting the intensity to 0 mA

17
before you remove the unit or the electrodes. If you do not end the treatment, you may experience
an unpleasant sensation in your fingers. This sensation is not harmful but can be unpleasant.
⚫Handle the unit with care. Do not drop, knock, or shake the unit. Rough handling can damage internal
circuit boards.
⚫Use this device only with the charger, cables, electrodes, and accessories recommended by the
manufacturer.
⚫Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or
electrically conductive medium (gel).
⚫Always disconnect the power charger from the mains after use.
⚫Please charge the unit at least every three months during long-term storage.
⚫Federal law restricts this device to sale by a practitioner licensed by the law of the State.
⚫Due to a mobile phone system upgrade or cyber-security upgrade, we will update MyndStep
Application in time. If the MyndStep Application fails due to a mobile phone system upgrade or other
reasons, you can download the latest version of the application from the APP store. Please contact
MyndTec Inc. for help if the problem still exists

18
FCC
Changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device under
Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used under the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-- Consult the dealer or an experienced radio/TV technician for help.