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OMNIHI5

USER MANUAL

MNL-0022

1. For Your Health and Safety

• To avoid any danger or injury caused by inappropriate use, please read this manual

carefully.

• Safety precautions include danger or injury caused by inappropriate use and are

categorized into sections of: Contraindications, Warning and Precautions.

• Please read this manual carefully.

List of Symbols

Contraindications, that may cause danger

Mandatory requirement or may cause an injury or physical discomfort

Type BF Equipment

Warning

Non-Ionizing Radiation

Date of Manufacture

Manufacturer

This product must not be disposed of with other household waste

Refer to user manual

Serial Number

The number of the notified body (0123)

European Authorized Representative

Fragile

Keep upward

Keep dry

Degree of Ingress Protection (for Control Unit)

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Consult instructions for use

Medical device

Single Patient-multiple use

Содержание XFT-2003E

Страница 1: ...User Manual Nerve and Muscle Stimulator Trade Name Hand Rehab System XFT 2003E MNL 0022 Caution Thanks for choosing our product Please read this manual before use and keep it carefully...

Страница 2: ...ustration 8 4 Setup Instruction 12 5 Operation Instruction 14 6 Care and Maintenance 38 7 Product Configuration 39 8 Product Specifications 40 9 Troubleshooting 43 10 Frequently Asked Questions 44 11...

Страница 3: ...es sEMG Surface EMG uses electrode like sensors to assesses muscle function by recording muscle activity from the surface above the muscle on the skin FES Functional Electrical stimulation NMES Neurom...

Страница 4: ...tions that may cause danger Mandatory requirement or may cause an injury or physical discomfort Type BF Equipment Warning Non Ionizing Radiation Date of Manufacture Manufacturer This product must not...

Страница 5: ...y in 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...

Страница 6: ...dures when muscle contraction may disrupt the healing process c Over the belly of a pregnant women d Over areas of the skin which lack normal sensation Some patients may experience skin irritation or...

Страница 7: ...omize evidence based objective and effective rehabilitation treatment programs for each patient Innovations Collection and processing technology that records the patient s EMG signals EMG triggered st...

Страница 8: ...ction and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury Neuromuscular Electrical Stimulation NMES 1 Increase or maintain hand ra...

Страница 9: ...el Electrodes optional 3 1 1 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 3 Electrode wire Op...

Страница 10: ...eration Panel 3 2 1 Operation button instruction Mode Button Wristband OLED Screen Down Selection Button Play Pause Button Intensity Button USB Port Power Button Upper Selection Button Intensity Butto...

Страница 11: ...e available Play Pause Button Start or pause in NMES ETS PAS and EMG mode Intensity Buttons Adjust the stimulation intensity during operation Press to increase intensity or to decrease intensity Inten...

Страница 12: ...red when user contacts the muscle EMG Mode It displays when you choose EMG mode The columnar and parameter represent the EMG power train by following the instruction 3 second relax for 3 times and 6 s...

Страница 13: ...de button to choose the mode NMES mode ETS mode PAS mode EMG mode GAME mode to start the treatment 6 After the treatment is complete press the power button to turn off the device 7 Take off the device...

Страница 14: ...of the charging cable to the charging port of the Stimulator 4 The battery icon will display on the screen of the Stimulator to indicate charging 5 The battery icon will display on the screen of the...

Страница 15: ...infectant is a 75 medical alcohol Wipe the electrode 3 times with a sponge or a soft cloth dampened with disinfectant Before using the device please use water to clean and wet the skin area where elec...

Страница 16: ...g NMES ETS PAS EMG and GAME mode 5 1 3 Mode Selection 5 1 3 1 NMES Press the Play Pause button to start the treatment and press or to adjust the intensity 5 1 3 2 ETS Press the Play Pause button to st...

Страница 17: ...the Play Pause button to start EMG signal test The stimulator will test the EMG signal in 3 cycles of 3 seconds relax and 6 seconds flex and then comes the average value 5 1 3 5 GAME GAME mode is not...

Страница 18: ...2 5 2 Uses with the app 5 2 1 Download or update app 1 Connect to WIFI Check in Settings to see if your iPad is connected to a Wi Fi network If not connected select the WiFi that can be connected and...

Страница 19: ...p named as SEMG 2003E system App for iOS iOS iOS 9 0 or above iPad Recommend iPad 4 and later iPad WIFI support No Network Bluetooth SSD storage more than 16G Network requirements when using the APP T...

Страница 20: ...earing the Stimulator Wear the device at the correct location See 5 1 1 Wear the Stimulator according to your need and corresponding motor response Add ample amounts of water to the area of skin that...

Страница 21: ...o select the GAME mode on the stimulator 2 Run SEMG 2003E app on the iPad 3 Account registration is required for the first use 4 Enter the account number password and confirmation password as required...

Страница 22: ...OMNIHI5 USER MANUAL 21 MNL 0022 3 Register an Account 4 Log in the account Confirm Password 5 Change Password 6 Enter Password and Confirm Password 7 Log in on the iPad 8 Search device...

Страница 23: ...reate Patient Information 1 Click the patient icon to enter patient list page 2 Click icon to add patient record 3 Edit the patient information and Save 1 Click the patient icon to enter patient list...

Страница 24: ...a pop up window will show 4 Click OK to send the selected prescription to the Stimulation 5 Another pop up window will display to indicate that the prescription is sent successfully click OK to retur...

Страница 25: ...r the home page of ETS PAS mode 2 Click ETS icon to switch to ETS mode 3 Click Setting icon to pop up the window of parameters 4 Adjust the parameters by sliding the finger on the screen for each para...

Страница 26: ...OMNIHI5 USER MANUAL 25 MNL 0022 3 Click the setting icon 4 Set the parameters 5 Click OK to send the parameters 6 Press Start icon to start the treatment 7 Intensity value 8 EMG ranges...

Страница 27: ...d 2 1000uV Pulse width 50 450 us 10ps increment Frequency 2 100Hz 1 Hz increment Ramp up 0 5s 0 1s increment Ramp down 0 5s 0 1s increment Duration 1 10s 0 1s increment Delay 0 5s 0 1s increment 3 dif...

Страница 28: ...mode 3 Click Start icon to start the treatment 4 Press or on the stimulator to adjust the intensity and the intensity value will display on the iPad 5 User can click icon of LOW MED or HIGH to display...

Страница 29: ...page of EMG mode 2 Click Start icon to start EMG test and the whole process will last 15 seconds 3 User can click icon of LOW MED or HlGH display different range of EMG 4 When the EMG test is complet...

Страница 30: ...ation training Patients control the games by contracting certain muscles while enjoying the fun of a rehabilitation game mode format 1 1 Click icon to enter the home page of EMG mode 2 Six games are n...

Страница 31: ...G Set the appropriate threshold by sliding the finger on the screen Press Start icon to start the game 3 Contact and relax the muscles to control the game Once the EMG value exceeds the threshold the...

Страница 32: ...MG 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 value exceeds the threshold t...

Страница 33: ...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 value exceeds the threshold...

Страница 34: ...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 value exceeds the thresh...

Страница 35: ...ow will show the threshold of the EMG Set the appropriate threshold by sliding the finger on the screen Press Start icon the start the game 4 Contract and relax the muscles to control the game Once th...

Страница 36: ...f 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 value exceeds the thre...

Страница 37: ...e to be limited then the limit value can be set as 0 5 3 2 Treatment Intensity Limit The user can set up an intensity limit by using the application for example if the user sets up the maximum intensi...

Страница 38: ...ctrodes loose indicator will display and the stimulator will stop when the electrodes and the skin have poor contact Please adjust the electrodes and press Play Pause button again to restart 5 3 5 Aut...

Страница 39: ...etergent or hot water Electrodes should be covered with the film when not in use Keep it clean and restore it carefully 6 3 Skin Care Please check your skin condition before and after use Slight redne...

Страница 40: ...ile charging The XFT 2003E Nerve and Muscle Stimulator has a rechargeable battery that can only be replaced by an XFT Battery cycle times 500 times The device needs about 3 hours to charge when comple...

Страница 41: ...ance 5M Common mode rejection ratio 100dB Power frequency notch 50Hz 100uV Peak to valley after attenuation 5uV Peak to valley Indication accuracy 10 2uV whichever is greater Feedback threshold accura...

Страница 42: ...Rate 0 1 Packet Loss Not available Signal to noise Ratio 88dBm The wireless QoS need XFT 2003E Nerve and Muscle Stimulator was designed and tested to have a response rate of 10 100ms latency depending...

Страница 43: ...0 10 5 10 17 2 1 40 200 11 6 15 11 2 1 60 200 12 6 8 13 2 2 40 200 13 3 2 5 0 0 5 300 14 6 6 25 2 1 25 150 15 8 12 25 2 1 35 100 16 6 5 21 2 2 40 50 17 3 2 5 0 0 5 300 18 6 6 25 2 1 25 200 19 8 12 25...

Страница 44: ...of the electrodes Stimulator cannot power on 1 Confirm that the power button is in good contact Release the power button gently wipe the button and finger with water then press the power button again...

Страница 45: ...a Stop using the device immediately b Continue to use the device only after the skin completely recovers to normal c If the skin irritation continues cease use of the device and notify your physician...

Страница 46: ...ice will back up your data and system setting automatically 10 7 How to keep my device safe from Cyber Threats a Only buy smartphones from vendors who authorized ensure your mobile phone operation sys...

Страница 47: ...ts which might cause operation parameters beyond the standards Please shutdown these devices when you are near the equipment The clinician has the responsibility to warn user or any others to comply w...

Страница 48: ...wer quality should be that of a typical commercial or hospital environment Surge 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 V...

Страница 49: ...VP E At RF wireless communications equipment bands Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches...

Страница 50: ...strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theor...

Страница 51: ...A 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulationb 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse Modulationb 217 Hz 2 0 3 28 5240 5100 5800...

Страница 52: ...ommunications equipment to prevent electromagnetic interference Following recommended distance is calculated according to the maximum output power of the communication equipment Rated maximum output p...

Страница 53: ...ators they are required to meet below requirement at least Ability to read and understand user manual and follow the instruction to operate device Are healthy or use the device under doctor s directio...

Страница 54: ...nctions caused 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 us...

Страница 55: ...uyer s Information ______________________________________________________________________ Distributor s Information __________________________________________________________________ Manufacturer Shen...

Страница 56: ...l Limited Room 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...

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