MyndStep 800102 User Manual

Foot drop stimulator

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Page 3: Table Of Contents
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 ...............................
Page 4: Foreword
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.
Page 5: Working Principle
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) •...
Page 6 Communication of Mobile Phone APP and Bluetooth PWM Intensity Adjustment Bluetooth Chip Pulse Processor Electrode Generating Power AC Input Battery Current Adapter Feedback Button...
Page 7: 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.
Page 8 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. Do not place the electrodes on the carotid sinus region. Do not place the electrodes over the eyes, pregnant women's waist or abdomen or other specific areas.
Page 9 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.
Page 10: Safety Instructions
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)
Page 11 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.
Page 12 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...
Page 13 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.
Page 14 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.
Page 15 ⚫ 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.
Page 16 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).
Page 17 ⚫ 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.
Page 18 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.
Page 19 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...
Page 20 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.
Page 21 ⚫ This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.
Page 22 The Bluetooth SIG, Inc. owns the Bluetooth® word mark and logos, and any use of such marks by MyndTec Inc. is under license. Communication between the main unit and the MyndStep Application on the smart phone is via Bluetooth. Bluetooth Specifications: Bluetooth Version: 4.0...
Page 23: Emc Guidance
EM disturbances is high. ⚫ Do not place MyndStep adjacent to or stacked with other equipment, or it could result in improper operation. If such use is necessary, all the devices should be observed to verify that they are operating normally.
Page 24 MyndStep could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Accessory Information: Item Cable Length Manufacturer & Part Number Shenzhen Longxc Power Supply Co., LTD Power cord with 3/f, B building, Wentao Industrial Park, Yingrenshi Yongxin Road, 1.0 m...
Page 25 Guidance and manufacture’s declaration – electromagnetic emission MyndStep is intended for use in the electromagnetic environment specified below. The customer of the user of MyndStep should ensure that it is used in such an environment. Electromagnetic environment – guidance Emission test...
Page 26 Guidance and manufacture’s declaration – electromagnetic immunity MyndStep is intended for use in the electromagnetic environment specified below. The customer or the user of MyndStep should ensure that it is used in such an environment. Electromagnetic environment - Immunity test...
Page 27 70% U ; 25/30 cycles interruptions, it is recommended input lines Single phase: at 0° Single phase: at 0° that MyndStep be powered from an IEC 61000-4-11 uninterruptible power supply or a 0% U ; 250/300 0% U ; 250/300 battery.
Page 28 Guidance and manufacture’s declaration – electromagnetic immunity (Continued) MyndStep is intended for use in the electromagnetic environment specified below. The customer or the user of MyndStep should ensure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level...
Page 29 Table: Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Immunity Test frequency Maximum Distance Band (MHz) Service Modulation TEST LEVEL (MHz) power (W) (V/m) Pulse Modulation 380 to 390 TETRA 400 18Hz ± 5 Hz 430 to 470 GMRS 460, deviation: 1 kHz FRS 460...
Page 30 1720 Pulse Modulation 1700 to 1990 GSM 1800; 1845 217 Hz CDMA 1900; 1970 GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 2450 Pulse Modulation 2400 to 2570 Bluetooth, 217 Hz WLAN, 802.11 b/g/n , RFID 2450, LTE Band 7 5240 Pulse Modulation 5100 to 5800 WLAN 802.11...
Page 31: Inspection Of The Goods
Inspection of the Goods 1. Unpacking the Unit The unit is generally delivered with the packaging material supplied by the manufacturer. Proceed as follows: ⚫ Position the transport packaging so that the arrows are pointing upward. ⚫ Remove the transport packaging upward. ⚫...
Page 32 MyndStep Self-Adhesive Electrode with Magnetic pieces Connection (800111) MyndStep Foot Drop Brace (800112) piece MyndStep User Manual (800115) piece Other parts of MyndStep are available as accessories on demand. Visit the website www.myndtec.com or call us at 1-888-363-058 to obtain more information.
Page 33: Overview Of The Unit
Overview of the Unit 1. Nomenclature Increasing intensity button ON/ OFF button Decreasing intensity button Output socket: connect electrode lead hose Micro-USB port: connect power adapter. Slide the Indicator light: see table: slider to output sockets when charging. meaning of indicator light...
Page 34 Table: meaning of indicator light Status Indicator color Way of flashing Power off None None Flash at 3Hz frequency. Flash at 1Hz Bluetooth is connecting Green after successful connection Ready Green Flash at 1Hz frequency Stimulation on Yellow Slight light (may be ＞10mA (r.m.s) or 10V (r.m.s)) Flash at 3Hz frequency for 1s, and Low battery cannot be used...
Page 35 2. Accessories 2.1 Lead Wire The side for connecting device output socket; The side for connecting electrodes. 2.2 Self-adhesive Electrode The part which contacts the patient is the backside of the electrode, and the material is a conductive hydrogel. When using, place the electrodes on the patient's skin, and connect the snap button of the electrode to the electrode lead hose.
Page 36 Model Picture Size Connector Remark 50mm×50mm Snap 800111 Standard (square) Ф 3.0 mm...
Page 37 2.3 Foot Drop Brace...
Page 38: Myndstep Application
You can download the MyndStep Application from the APP stores. Download the Android version from Google Play and the IOS version from Apple App Store. Click the MyndStep Application installation package on your phone, and follow the prompts to install the application.
Page 39 2. Connect the Device Click “click here to connect the device” at the main interface to connect the MyndStep Application on the phone and the device via Bluetooth. The APP will search the devices automatically, as shown below. When it searches, the interface will display the device found.
Page 41 Click to view the device information, such as battery percentage, hardware and software version of the device. Also, you can click “Identified Color” to select a color to distinguish other units. Select a color and confirm, then paste the same color label on the unit surface.
Page 42 3. Main Interface Open the MyndStep APP and you can see the main interface, as shown on the left. The software has the power display function; the main interface in the upper right corner shows the main unit's power. There are two modes on the MyndStep: Train Mode and Walk Mode.
Page 43 3.1 Train Mode Interface Enter the train mode interface Click Train Mode at the main interface to enter this interface, as shown on the left. The current regulation module displays the connection status. The gray circle indicates that the device did not connect. Once it connects, it will become blue, as the following picture shows.
Page 44 Set the parameters Frequency, expressed in Hz, defines the repetition rate of the pulses. Pulse duration (or pulse width), expressed in μs, defines the length of the pulse. Set frequency, pulse width (pulse duration) and treatment time Take frequency setting as an example. Click the frequency bar, and pop up the frequency setting window, as shown on the left.
Page 45 Set the Pulse Train Modulation Click the icon , and enter the Pulse Train Modulation Interface, as shown on the left picture. Set each parameter under Pulse Train Modulation. The setting method is the same as the frequency setting. After all the settings are complete, click the OK button, and the page jumps to the training mode interface.
Page 46 Table: Parameter setting of Train Mode Parameter Setting Range Default Increment Frequency Hz 10-80 Pulse Duration μs 50-500 Pulse Train Modulation * Ramp up time s 0.5-5.0 Hold time s 1.0-30.0 Ramp down time s 0.5-5.0 Interval time s 2.0-60.0 10.0 Treatment time min 1-60...
Page 47 Parameter Description of Pulse Train Modulation Ramp up time (t ): the time of the intensity gradually increases from 0 to the set level to avoid a sudden increase in intensity and make the treatment more comfortable. Hold time (t ): the time that the intensity is maintained at the set level, is the time when the electrical stimulation is activated.
Page 48 Start treatment When the parameters are set, click the start button to start the treatment. Meanwhile, the circle will turn blue. Adjust output intensity Output intensity, expressed in mA, defines the amplitude of the pulse. After clicking the start button, the output intensity can be adjusted.
Page 49 Tips to change mode If you click other modes during the treatment, the interface will automatically go to the current treatment interface and appear as shown on the left. If you want to change the mode, press and hold the stop button to stop the current treatment.
Page 50 3.2 Walk Mode Interface 1) Enter the walk mode interface Click Walk Mode at the main interface to enter this interface, as shown on the left. The current regulation module displays the units which had connected. The gray circle indicates that the device did not connect.
Page 51 4) Set the parameters Table: the parameter setting of Walk Mode Parameter Setting Range Default Increment Frequency Hz 10-80 Pulse duration μs 50-500 Output intensity mA* 0-100 The output intensity is adjustable only after starting. 5) Treatment Setup After setting the output frequency and pulse duration, click Setup.
Page 52 6) Calibrating the sensor After setup click next step to jump to the interface of Sensor calibration. At this stage, there is no electrical stimulation output. Stand upright according to the figure on the APP and click on "Calibrate" to calibrate the sensor.
Page 53 7) Enter the treatment interface of Walking Mode After the calibration is completed, it will automatically enter the walking mode treatment interface. The following parameters are displayed in real-time after startup: ITEM Description Displays the step numbers you have walking. Displays the distance you have walked.
Page 54 Knee Extension/Flexion Angle Hip Abduction/Adduction Angle NOTE: The device can trigger electrical stimulation when the patient's knee angle rises to -30°, and it can trigger electrical stimulation. When the patient's knee angle drops to -5°, the device's electrical stimulation output is turned off. The duration of electrical stimulation is 1s-3s.
Page 55 8) Start treatment Click the start button to start the treatment. The output current is the value of the previous intensity setting. The intensity can be adjusted again at this step if needed.
Page 56 9) Tips for change mode If you click on other modes during the treatment, the interface will automatically go to the current treatment interface and appear as shown on the left. If you want to change the mode, press and hold the stop button to stop the current treatment.
Page 57 4. Open Circuit Tip When the output is disconnected during treatment, the indicator on the device will flash white at 1 Hz; the treatment time stops counting down, and the APP displays a pop-up tip. At the same time, the device stops output (i.e., the output intensity is reduced to 0 mA).
Page 58 5. About Favorites 1) Add Custom Protocol MyndStep can save custom protocols in train mode. Click the train mode at the main interface to enter the interface, and set the frequency, pulse duration, treatment time and pulse train modulation parameters. Click “Favorites” in the upper right corner, then pop up the page as shown on the left, set the name of the custom protocol and click the OK button.
Page 59 2) Enter treatment from a custom protocol Click the icon in the upper right corner of the main interface, or swipe the interface in the main interface to view more. Click the icon to enter the custom protocol. Choose one custom protocol you want and click to enter the detail page, which shows the treatment parameters of the custom protocol.
Page 60 6. Help Center Click the icon in the upper left corner of the main interface, or press “more” at the bottom of the main interface to see more, click the icon and enter the help center interface.
Page 61 6.1 Using guidance There is some introduction on how to operate MyndStep to help you understand the use of the device.
Page 62 6.2 FAQ MyndStep Application includes a variety of common problems, and you can learn more about MyndStep and treatment.
Page 63: Operation Guidance
Operation Guidance 1. Preparing for Use 1.1 Charging the unit To use the device, you first have to charge the unit. One side of the power adapter connects with the unit; another side connects with the power socket. The status indicator on the unit flashes blue during charging.
Page 64 Press the ON/OFF button to turn on the unit to standby. 1.3 Open the MyndStep and connect Turn on the MyndStep Application and connect the unit to your phone via Bluetooth. Two main units can be connected simultaneously, and two units can perform electrical stimulation simultaneously.
Page 65 Select Train Mode and set parameters: Click Train Mode at the main interface to enter the Train Mode interface, set parameters such as frequency, pulse duration and treatment time according to the actual situation (see Clause 3.1 in chapter MyndStep Application). Start Treatment: Click the start button, and the treatment begins.
Page 66 Adjust output intensity: You can adjust the output intensity in the MyndStep interface or through the “+/-" buttons on the unit. The output intensity should be increased slowly from small values to avoid excessive stimulation. Because your body initially adapts to the intensity of the stimulation, you may have to adjust the intensity level after some time to ensure optimal stimulation.
Page 67 Clean the skin and place the electrodes: Use alcohol or soapy water to clean the skin, remove the grease. After the skin dries, place electrodes according to the schematic of the MyndStep APP. Place one electrode on the Common peroneal nerve and the other one at the point of tibialis anterior of the leg (Located on the outside of the calf).
Page 68 Select Walk Mode and setup: Click Walk Mode at the main interface to enter the interface, click Treatment Setup, and adjust output intensity. Fix Leg Brace: After finishing setup, fix the strap on the calf according to the schematic of the MyndStep APP, and place the unit into the pocket of the Leg Brace.
Page 69 Calibrate the sensor: click “next step” at MyndStep APP, Stand according to the schematic of the APP, and click “Adjust”. Start treatment: After calibration is completed, it is automatically transferred to the treatment interface. Click the start button, and then you can start your walking training.
Page 70 In Train Mode, the device will stop the treatment automatically after the end of the training, and the MyndStep application interface shows “the treatment is finished”. In Walk Mode, you need to stop the treatment manually. Please press and hold the stop button to stop the treatment. The unit stops output.
Page 71: Care And Maintenance
Care and Maintenance 1. Cleaning Turn off the device before cleaning and disinfection; For the main unit cleaning, what is recommended are a clean, soft damp cloth for stains, and a clean, soft dry cloth for dust on the surface of the main unit; Clean the Leg Brace: Wipe the surface with a damp cloth or antiseptic wipe after use.
Page 72 2. Routine Maintenance If it is used under the user manual's instructions, the device does not require particular regular maintenance. The manufacturer will provide circuit diagrams, component lists, descriptions, and calibration instructions to assist service personnel in parts repair. Check the unit and accessories at regular intervals. 1) Check the power line to ensure no distortion, fracture, etc.
Page 73 ⚫ Never perform unauthorized service work. All service work must be performed only by service technicians whom the manufacturer has authorized. 3. Disposal According to EC Directive – WEEE (Waste Electrical and Electronic Equipment), the equipment must not be disposed of as unsorted municipal waste and must be collected separately. Dispose of this product according to local regulations.
Page 74 This symbol indicates that batteries contain substances that may be harmful to humans or the environment. Never dispose of these batteries with household waste. Please take them to an official collection point or a service center to remove the rechargeable battery and follow the local rules for a separate collection of the batteries.
Page 75: Troubleshooting
Troubleshooting This chapter summarizes the most common problems you could encounter with MyndStep. If you are unable to solve the problem with the information below, please call your distributor. Issue Possible causes Solutions 1. The indicator does not The battery of the unit is empty.
Page 76 Issue Possible causes Solutions 3. The status indicator on The battery of the unit is empty. Charge the unit (see chapter the unit flashed white, and Preparing for use). the unit switched off. 4. There is no output. 1. Did not press the start button; 1.
Page 77 Issue Possible causes Solutions 6. The MyndStep APP on 1. The electrode lead wire is 1. Re-connect the electrode lead the mobile phone pop up poorly connected; wire; tips “electrodes fall off”, and 2. The electrodes are in poor 2. Re-connect the electrodes and the indicator of the unit contact with the skin;...
Page 78: Technical Specifications
Technical Specifications 1. Stimulator Output Parameters Channel: Single channel Output Waveform: Symmetrical biphasic pulse Treatment Mode: Train Mode and Walk Mode. Pulse Duration: Adjustable, 50-500μs, increments of 10μs Pulse Frequency: Adjustable, 10-80Hz, increments of 1Hz Pulse Train Parameter Range Stepping Modulation: Ramp up time (s) 0.5-5.0...
Page 79 When finished, the device can stop output and prompt. Output Intensity: Adjustable, 0-100mA, increments of 1mA (at 500Ω load) Maximum Output 55 V at 500 Ω Load Amplitudes (V): Maximum Current 50mA r.m.s.at 500 Ω Load (r.m.s): 2. Other Specifications Product Name MyndStep Foot Drop Stimulator Model 800102...
Page 80 Software Release Stimulator (main unit): A MyndStep Application: 1 (Android & iOS) Power Supply: Adapter model: LXCP12X-050200DG (USA) LXCP12X-050200BG (Europe) Adapter supply voltage: AC100-240V, 50/60Hz Adapter output: DC 5V, 2A. Battery: 3.7V, 1200 mAh, lithium battery. Line Current Isolation: Patient disconnected when charging.
Page 81 Weight: 60g (only main unit) Classification (IEC 60601-1): Class II, Type BF Applied Part; ⚫ Classification: ⚫ Ingress Protection: IP22; ⚫ Mode of Operation: Continuous. Environmental ⚫ Temperature: 5 to 40°C; conditions of ⚫ Rel. humidity: 15 to 80%; operation: ⚫...
Page 82: Assistance
Assistance Any intervention on the device must be performed by the manufacturer. For any assistance intervention and original spare parts, please contact the manufacturer at the following address: MYNDTEC INC. 1900 Minnesota Court, Suite 122 Mississauga, ON, L5N 3C9 Info@myndtec.com Tel: 1-888-363-0581 1-877-796-4624 Fax:...
Page 83: Warranty
Warranty Any unauthorized modifications or repairs will void this warranty. All repairs to the equipment must be performed by an authorized service center or the manufacturer. 1) Warranty for the main unit ⚫ This warranty shall remain in effect for two years (24 months) from the product's delivery date to the end customer.
Page 84 the authorized dealer will repair this product without charge. Damages due to non-adherence to the User Manual are excluded from the warranty. 3) This Warranty Does Not Cover: ⚫ Replacement parts or labor furnished by anyone other than the manufacturer, the authorized dealer or a certified company service technician.
Page 88 MyndTec Inc. 800116 Rev 1.0...