XFT Medical WalkAide II User Manual Download Page 1

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Technology Upgrades

Our Life

User Manual

Caution:
•

Please read the instruction manual carefully and thoroughly before operating this device.

•

Also please keep it available for future reference.

Summary of Contents for WalkAide II

Page 1: ...Technology Upgrades Our Life User Manual Caution Please read the instruction manual carefully and thoroughly before operating this device Also please keep it available for future reference ...

Page 2: ......

Page 3: ...3 Product Illustration 5 4 General Operation Instruction 10 5 Attentions 25 6 Care and Maintenance 26 7 FAQ Troubleshooting 28 8 Product Specifications 30 9 Product Classification 32 10 Electromagnetic Compatibility EMC 33 11 After sales Service 39 12 Use Specification 40 Warranty Card 41 ...

Page 4: ... Warning Non ionizing radiation Date of manufacture Manufacturer Serial Number Fragile handle with care Keep upward Keep dry The product is 1 Dust tight 2 Protected against the effects of temporary immersion in water Temperature limit Humidity limitation Atmospheric pressure limitation The number of the notified body 0123 Authorized representative in the European Community Refer to user manual Ple...

Page 5: ...oduct Please do not position the electrode in the area of malignant neoplasms neck arteries throat or thrombus Use caution when positioning electrodes in areas of altered sensation Do not apply electrodes to areas with compromised skin integrity Muscle training might cause disorder of rehabilitation of a recent surgery Electrode positioning areas are not sensitive enough Please use with caution wh...

Page 6: ...ystem detects and analyzes the patient s gait patterns in real time through the internal tilt and accelerometer sensors and then simul taneously delivers comfortable low frequency functional electrical stimulation FES to the common peroneal nerve This in turn will evoke muscle contract ion and enable the patient to actively walk with a more normalized gait The mo st common use of FES for a treatme...

Page 7: ...ct Parts XFT 2001E consists of the Stimulator Power Adapter charging cable and app software optional 3 1 1 Stimulator Stimulator 3 1 2 Parts No Parts Picture Description 1 Power Adapter The Power Adapter and Charging Cable are used to charge the device 2 Charging Cable ...

Page 8: ...his button for 2 seconds to turn off the stimulator In the working state tap this button to pause the electrical stimulation Intensity Buttons Tap one of the buttons to start electrical stimulation and increase or decrease the electrical stimulation intensity click the up button to increase the intensity and click the down button to decrease the intensity OLED Display Display various working state...

Page 9: ...ause When the stimulator is in the pause state press or to activate the electrical stimulation intensity press the up button to increase the intensity and press the down button to decrease the intensity The display will show the corresponding intensity value Stimulation Intensity Stimulation Intensity Electrical Stimulation Output Prompt When the stimulator is delivering electrical stimulation the...

Page 10: ...e mode Electrode Loose Electrode Loose Low Battery Charging Prompt When the stimulator is in low battery there will be a battery icon flashing once per second on the screen The dynamic charging icon is displayed while charging and the full battery icon is displayed when charging is completed Low Battery flash once per second Charging Charging Full Charge Automatic Screen Saver The screen saver wil...

Page 11: ...nts Data transmission between app software and device is carried out through specific Bluetooth service channel data format and data verification requirements are required at the same time which can avoid connection and control of other devices or software When the connection between app software and device is interrupted during usage app software will give a reminder of disconnection and you can ...

Page 12: ...fectant 4 2 How to Use XFT 2001E XFT 2001E can be used with or without app Please check if the stimulator is fully charged before use If necessary please charge the stimulator The display will indicate the battery icons when charging Connect charging cable to the power adapter Connect charging cable to the stimulator Connect power adapter to the power outlet How to charge the Stimulator During use...

Page 13: ... bend and relax the leg Place the stimulator in the correct position under the knee Position the cuff on the leg below the knee Align the vertical edge of the stimulator with the tibia Fasten the cuff but don t violently pull the cuff To optimize individual function the stimulator position might be adjusted slightly please consult the fitter ...

Page 14: ... press the up button to increase the intensity and press the down button to decrease the intensity The display will show the corresponding intensity value Stimulation Intensity Stimulation Intensity Note In order to allow the skin area covered by the stimulator to breath and to prevent skin irritation and redness stimulation should be suspended and the stimulator removed at regular intervals This ...

Page 15: ...e a user ID for the first time 4 4 2 Wear the Stimulator Use a wet towel to clean the skin of the leg Sit on a chair bend and relax the leg Place the stimulator to the correct position under the knee Position the cuff on the leg below the knee Align the vertical edge of the stimulator with the tibia Fasten the cuff but don t violently pull the cuff To optimize individual function the stimulator po...

Page 16: ...imulator display shows XFT LOGO for 2 seconds Tap this button to switch between Gait mode and Training mode 4 4 3 1 Login the app and connect the Stimulator to the app via Bluetooth Procedure Operation Description App Interface Step 1 Open the Bluetooth on your mobile phone and run the app Step 2 Enter your name and Password and press the Login icon to login ...

Page 17: ...I USER MANUAL 15 MNL 0023 Step 3 Press the search icon to search for the stimulator Step 4 Select the stimulator in the Equipment List and enter the home page Step 5 Select mode between Gait mode or Training mode ...

Page 18: ...ally calculates the tilt angle A to start the electrical stimulation and the tilt angle B to end the electrical stimulation according to the gait data of the first four steps of the patient The parameters hat can be adjusted are the electrical stimulation intensity frequency and pulse width in the lower level interface of the Parameter Settings 2 Normal Mode The stimulator performs electrical stim...

Page 19: ...art comma nd to the stimulator receives the stimulator s reply and enters the Training work interface 2 Pause The app sends a Training mode pause stop command to the stimulator receives the Stimulator s reply and the Training is suspended 3 Continue The app sends the Training mode start and you have to adjust the intensity again After receiving response and the training work continues 4 End After ...

Page 20: ...tion mode to start the command to the stimulator receives the Stimulator reply and enters the evaluation work interface 3 End After long press and stop for 1 5 seconds send the Evaluation mode stop commando the stimulator the App receives the stimulator s reply and the eval uation mode stops 4 The evaluation mode stops calculating the reference parameters based on the collected data The collected ...

Page 21: ...ANUAL 19 MNL 0023 4 4 3 2 The APP Consists of 3 Sections Activity Stats and Me 4 4 3 2 1 Activity Gait mode Procedure Operation Description APP Interface Step 1 Set the parameters Step 2 Adjust the stimulation intensity ...

Page 22: ...WALKAIDE II USER MANUAL 20 MNL 0023 Step 3 Press and hold the button for 1 5 seconds to end the session ...

Page 23: ...USER MANUAL 21 MNL 0023 Training mode Procedure Operation Description APP Interface Step 1 Set the session Step 2 Adjust the stimulation intensity Step 3 Press and hold the button for 1 5 second to end the session ...

Page 24: ...WALKAIDE II USER MANUAL 22 MNL 0023 4 3 3 2 2 Stats There are 4 types of statistics Day Week Month and Year Day Week Month Year 4 3 3 2 3 Me Change your profile photo ...

Page 25: ...WALKAIDE II USER MANUAL 23 MNL 0023 Edit personal information Equipment Information In the page of Equipment you can see the name of the stimulator and App version ...

Page 26: ...ng From the Setting page you can turn on or turn off the buzzer on the stimulator set the auto off time switch to Pro version restore factory setting or Exit Please note that it requires the appropriate professional knowledge and should be used by a physician or a qualified clinician for the Use of the Pro version ...

Page 27: ...t the place of the electrode and press the Power Mode Button again 5 1 2 Low Battery When the stimulator battery is low the battery icon flashing once per second on the screen 5 2 Allergy Prevention Advice Do not position on the skin with makeup or oil Remove the hair on the treatment part for better electrical conductivity Electric razor or a pair of scissors is recommended If any skin irritation...

Page 28: ...ed when not in use 6 3 Skin Care Please check your skin condition before and after use Slight redness is normal and it indicates the blood circulation is faster in this area Always add ample amounts of water to the area of skin that will be in contact with the electrodes 6 4 Skin Irritation Prevention Use water to remove all makeup unclean areas or oil from the skin Do not position the electrodes ...

Page 29: ...ly drained of power The device is designed to work for 10 hours with a full charge 6 7 Device Storage Please do not store the device in a place with direct sunlight high temperature or moist dusty or corrosive gas Please store the device in a place out of reach from children The user does not need to maintain the device please ask the seller or manufacturer Please do not throw tread on or heavy pr...

Page 30: ...electrode and the skin Q3 What should I do if the skin in the area covered by the electrode and the cuff is severely red stinging or allergic Stop using it immediately After observing for a period of time if no abnormality is found wait until the skin is completely improved before continuing to use the device Remember to regularly ventilate the skin covered by the stimulator Q4 The stimulator auto...

Page 31: ...tened well to the leg or the electrode has been placed on the current position Q7 Why can t I feel the stimulation when there should be stimulation output Normally it is because the cuff position has been changed or the Gait mode has been changed Please readjust the stimulator placement or reset the parameters of Gait mode Q8 Can I use oil or lotion on my legs No please make sure the skin is clean...

Page 32: ...0mA Wave form Asymmetric biphasic balanced wave Frequency 16 50Hz 10 Pulse Width 100 300µs 10 Output Intensity 0 90mA 10 or 2mA whichever is greater with 500Ω load Dimension 133mm 10mm 102 5mm 0 15mm 13 8mm 5mm Weight 155 109 8 3 Power Adapter The power adapter used with the unit can be purchased from our company or in the market according to the following requirements The rated output of the powe...

Page 33: ...oftware Optional 8 6 Wireless Technology Description Type of wireless technology Bluetooth V4 0 BLE Wireless function Transmission the device data and the patient data from transmission terminal equipment to receiving terminal equipment as well as ensuring the integrity and security of data during transmission Modulation Type GFSK Modulation Signal Type Digital RF Band wise 2402MHz 2480MHz Channel...

Page 34: ...y type of electric shock internal power supply b The application part is classified according to the degree of electric shock BF type c Classified by degree of protection against incoming liquid IP67 d Classification according to the degree of safety when using flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide no gas cylinder non AP and APG type...

Page 35: ...control products which might cause operation parameters beyond the standards Please shutdown these devices when you are near the equipment Operator has the responsibility to warn user or any others to comply with this rule Caution manufacturer will not responsible for any unauthorized actions that cause interference The ME EQUIPMENT or ME SYSTEM is suitable for home and healthcare environments War...

Page 36: ...ended for use in the electromagnetic environment specified below User should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This equipment uses RF energy only for its internal function Its RF emissions are very low and are not likely to cause any interference in nearby electronic RF emissions CISPR 11 Class...

Page 37: ...uality should be that of a typical commercial or hospital environment Surges IEC 61000 4 5 0 5kV 1kV line to line 0 5kV 1kV 2kV line to ground 0 5kV 1kV line to line 0 5kV 1kV 2kV line to ground Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT ...

Page 38: ...g of the transmitter in watts according to transmitter manufacturer and d is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by an electromagnetic site survey b should be less than the compliance level in each frequency range c Interfere nee may occur in the vicinity of equipment marked with the following symbol 6Vrms in ISM and amateur radio ...

Page 39: ...stance m IMMUNITY Test Level V m 385 380 390 TETRA 400 Pulse modulationb 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulationb 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 85 LTE Band 5 Pulse modulationb 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UM...

Page 40: ...F communications equipment to prevent electromagnetic interference Following recommended distance is calculated according to the maximum output power of the communication equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 7GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 ...

Page 41: ...ors Disassemble or modify the product without authorization Accidentally blow or drop the product during use or transportation Lack of reasonable maintenance Operate not according to the instruction Repaired by unauthorized repair store 3 When asking for warranty service please take with the warranty card It is charged according to the stipulation of the repair service of the warranty Please conta...

Page 42: ... No nationality or race limitation Can identify parts of body Use environment Reusable Hospital use or home use Use the EMC environment for Class 1 Group B Work conditions Work conditions Temperature 5 40 C Humidity 80 Non condensing Atmospheric pressure 86 106kPa Operation principle Place the Stimulator to correct position under the knee To optimize individual function the stimulator position mig...

Page 43: ..._ Buyer s Information ______________________________________________________________________ Distributor s Information __________________________________________________________________ Manufacturer Shenzhen XFT Medical Limited Add Room 203 Building 1 Biomedicine Innovations Industrial Park 14 Jinhui Road Pingshan New District Shenzhen China Tel 86 755 29888818 Web www xft china com Mail xft xft c...

Page 44: ... 203 Building 1 Biomedicine Innovations Industrial Park 14 Jinhui Road Pingshan New District Shenzhen China Tel 86 755 29888818 Fax 86 755 28312625 Website http www xft china com E mail xft xft cn Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany Date Oct 21 2022 Doc No ACP 2002E GB Version C3 ...

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XFT Medical WalkAide II, User Manual

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