background image

1

/

42

XFT-2003EA
Nerve and Muscle Stimulator (trade name: Hand Rehab System)

User Manual

Caution

: This is a class II FDA cleared medical device. Federal regulations restricts the order or delivery of this medical

device to certified clinicians licensed by the law of the State in which he/she practices to use as indicated within their scope
of practice. Order and delivery of this medical device for patient home use must be accompanied by a physician
prescription. Thanks for choosing our product. Please read this manual before use and keep it carefully.

Summary of Contents for XFT-2003EA

Page 1: ...rder or delivery of this medical device to certified clinicians licensed by the law of the State in which he she practices to use as indicated within their scope of practice Order and delivery of this...

Page 2: ...t Illustration 8 4 Setup Instruction 11 5 Operation Instruction 13 6 Care and Maintenance 29 7 Product Configuration 30 8 Product Specifications 30 9 Troubleshooting 32 10 Frequently Asked Questions 3...

Page 3: ...muscles EMG Surface EMG uses electrode like sensors to assesses muscle function by recording muscle activity from the surface above the muscle on the skin NMES Neuromuscular electrical stimulation is...

Page 4: ...carefully List of Symbols Contraindications that may cause danger Mandatory requirement or may cause an injury or physical discomfort Type BF Equipment Use with Caution Non Ionizing Radiation Date of...

Page 5: ...n that the introduction of electrical current into the heart may cause cardiac arrhythmias Stimulation should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thr...

Page 6: ...ference received including interference that may cause undesired operation Precautions Do not use near within one meter of short wave technology or a microwave Patients with heart disease severe hyper...

Page 7: ...tation progress to help medical professionals customize evidence based objective and effective rehabilitation treatment programs for each patient Innovations Collection and processing technology that...

Page 8: ...tion 2 4 Indications for Use The Nerve and Muscle Stimulator is an electrical stimulation device indicated for the following uses Functional Electrical Stimulation FES Improvement of hand and upper ex...

Page 9: ...ure 1 Power Adapter The Power Adapter and Charging Cable are used to charge the device 2 Charging Cable 3 2 Operation Panel 3 2 1 Operation button instruction OLED Screen Play Pause Button Mode button...

Page 10: ...at the same time Hold for 5 seconds to restore factory setting Play Pause Button press to start or pause the treatment or confirm the language Intensity Buttons Adjust the stimulation intensity durin...

Page 11: ...ng cycle the stimulator will change the ETS threshold to the average value of 3 times measuring data GAME mode The stimulator can connect to the APP under this mode Bluetooth indicator When you need t...

Page 12: ...s the mode Button 6 Press the power button 7 Remove the Stimulator 8 Clean the metal electrodes 4 2 Charging the XFT 2003EA Nerve and Muscle Stimulator 1 Take out the Power Adapter and the Charging Ca...

Page 13: ...h to avoid splashing into the inside of the device causing malfunction or danger The disinfectant is a 75 ethyl alcohol Wipe the electrode 3 times with a sponge or a soft cloth dampened with disinfect...

Page 14: ...1 3 Mode Selection 5 1 3 1 NMES Press Play Pause button to start the treatment and press or to adjust the intensity 5 1 3 2 ETS Press Play Pause button to start the treatment and press or to adjust t...

Page 15: ...PP 5 2 Use with the APP 5 2 1Download or update APP 1 Connect to WiFi Check in Settings to see if your iPad is connected to a WiFi network If not connected select the WiFi that can be connected and en...

Page 16: ...is limited to internal storage access in the APP It neither accesses patient information data from other systems or software nor imports patient information data into other systems or software The in...

Page 17: ...on the iPad Account registration is required for the first use Enter the account number password and confirmation password as required If you forget your password you can click to change it Enter and...

Page 18: ...atient record 3 Edit the patient information and Save 5 2 6 Mode Selection 5 2 6 1 NMES Mode 1 Click icon to enter the home page of NMES mode 2 Click the prescription number to enter the prescription...

Page 19: ...user can choose different prescription based on his her needs According to the international standard for electrical stimulation we have provided 42 preset prescription and 8 customizable prescription...

Page 20: ...5 300 22 6 6 25 2 1 25 300 23 8 12 25 2 1 35 300 24 7 10 17 5 0 40 150 25 5 4 10 2 1 5 300 26 6 15 11 2 1 60 50 27 6 12 17 2 2 40 100 28 6 4 19 2 2 40 200 29 3 2 5 0 0 5 400 30 5 8 22 2 1 30 400 31 8...

Page 21: ...the screen for each parameter 5 After all the parameters are set click OK to return to the home page of ETS mode 6 Click Start icon to start the treatment 7 Press or on the stimulator to adjust the in...

Page 22: ...1s increment Duration time It can be adjusted start from 1 s to 10s with 0 1s increment Interval time It can be adjusted start from 0 s to 5s with 0 1s increment 5 2 6 3 PAS Mode 1 Click icon to ente...

Page 23: ...the patient s spontaneous EMG intensity 5 2 6 4 EMG Mode 1 Click icon to enter the home page of EMG mode 2 Click Start icon to start EMG test and the whole process will last 15 seconds 3 User can clic...

Page 24: ...he games by contracting certain muscles enjoying the fun in rehabilitation 1 Click GAME icon 2 Home page of GAME mode Global Trip 1 Click the game icon of Global Trip and it will enter the game page 2...

Page 25: ...to move on 4 Click the to return to the home page of GAME mode 1 Click the game icon of Zombie Avenger 2 Game page 3 Threshod setting 4 Return to home page Funnies 1 Click the game icon of Funnies an...

Page 26: ...ll show the threshold of the EMG Set the appropriate threshold by sliding the finger on the screen Press Start icon the start the game 3 Contract and relax the muscles to control the game Once the EMG...

Page 27: ...racter will be triggered to move on 5 Click the to return to the home page of GAME mode 1 Click the game icon of Jigsaw Show 2 Game page 3 Threshod setting 4 Start game 5 Return to home page Clever Ba...

Page 28: ...and once the time is up The stimulator will be unavailable until another treatment time limit is set Note If user doesn t want the treatment time to be limited then the limit value can be set as 0 5 3...

Page 29: ...15 minutes if there is no operation 6 Care and Maintenance 6 1 Maintenance for Stimulator Always handle the stimulator carefully Do not expose the stimulator to water excessive heat or vibration Keep...

Page 30: ...tely place the electrodes as it could cause discomfort If any skin irritation or allergy occurs please stop using the stimulator immediately and follow doctor s instructions 6 5 Product Service Life T...

Page 31: ...ation 5 V Peak to valley Indication accuracy 10 2 V whichever is greater Feedback threshold accuracy 10 central frequency Type of stimulation output constant current Electrical stimulation intensity 0...

Page 32: ...ting Signal Digital Data Rate Frequency of Modulating Signal 1Mbps Receiver Bandwidth 2402 2480MHz Maximum transmission distance 10 meters Wireless QoS I U intended to unintended Ratio 1dB Throughput...

Page 33: ...red by the electrode and the stimulator band is severely red stinging or allergic Stop using the device immediately Continue to use the device only after the skin completely recovers to normal If the...

Page 34: ...d susceptibility requirements at a level of RF immunity testing from IEC 61000 4 3 of 60601 1 2 e g level of 10 volts per meter at frequencies from 80 MHz to 2 7 GHz However even at this level of devi...

Page 35: ...EC 61000 4 2 8 kV contact 2kV 4kV 8kV 15 kV air 8 kV contact 2kV 4kV 8kV 15 kV air Floors should be wood concrete or ceramic tile Humidity should be at least 30 if it is synthetic materials Electrical...

Page 36: ...voltage prior to application of the test level Table 3 Guidance and manufacture s declaration electromagnetic immunity The XFT 2003EA Nerve and Muscle Stimulator is intended for use in the electromag...

Page 37: ...MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz b Field stren...

Page 38: ...would be worst case Table 5 Recommended separation distances between portable and mobile RF communications equipment and the XFT 2003EA Nerve and Muscle Stimulator The device is intended for use in an...

Page 39: ...be estimated using the equation applicable to the frequency of transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer Note1 At 80M...

Page 40: ...d by the following behaviors Dismantle or modify the product without authorization Accidentally blow or drop the product during use or transportation Lack of reasonable maintenance Not using the devic...

Page 41: ...urn authorization number and specific instructions on the process Remove or copy this form and include it with the unit s Include copy of original invoice and return the device to the address in the R...

Page 42: ...3 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 US Age...

Reviews: