Table of Contents
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Product Name: Nerve and Muscle Stimulator
Model: XFT-2001D
Manufacturer: Shenzhen XFT Medical Limited
Add: Room 203, Building 1, Biomedicine Innovations Industrial Park,
#14 Jinhui Road, Pingshan District, Shenzhen, China
Tel: 86-755-29888818
Fax: 86-755-28312625
Web: www.xft-china.com
Mail: xft@xft.cn
ShangHai International Holding Corp.GmbH (Europe)
Eiffestrasse 80 D-20537 Hamburg Germany.
Date: July 15, 2019
No.: XFT-2001D-A(G)
Rev. C1
Thanks for buying our product, please read the user manual carefully before use and keep it properly.
G
3
Foot Drop System
User Manual
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Table of Contents
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Summary of Contents for XFT Medical G3 Series
- Page 1 Foot Drop System Product Name: Nerve and Muscle Stimulator Model: XFT-2001D Manufacturer: Shenzhen XFT Medical Limited Add: Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan District, Shenzhen, China Tel: 86-755-29888818 Fax: 86-755-28312625 Web: www.xft-china.com Mail: xft@xft.cn ShangHai International Holding Corp.GmbH (Europe)
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Page 2: Table Of Contents
Contents For Your Health and Safety Introduction to Your XFT-2001D 1.Introduction 2. Intended Use 3. Functions and Features Components of Your XFT-2001D 1. Components 2. Stim Unit & Cuff 3. Quick-fit Electrode 4. Remote Control Daily Use of Your XFT-2001D 1. -
Page 3: For Your Health And Safety
Distributor's information: Manufacturer Date of Manufacturer Contraindications Manufacturer: Shenzhen XFT Medical Limited Do not use on persons with implanted demand-type cardiac pacemakers or defibrillators. Add: Room 203, Building 1, Biomedicine Innovations Industrial Park, Do not place the electrodes over malignant tumors. - Page 4 Directions for Use The safety of XFT-2001D for use during pregnancy has not been established. Do not use simultaneously with high frequency hospital equipment (e.g. diathermy equipment). Warranty Statement It may result in burns at the site of the stimulator electrodes and possible damage to the stimulator. Improper or prolonged use of electrodes may result in increased risk of skin irritation or burns and decreased effectiveness.
- Page 5 Never use the XFT-2001D if it appears to be malfunctioning. If there is a change in the way it usually works (i.e. change in sensation, surging of stimulation, intermittent stimulation) do not use the XFT-2001D and contact your clinician immediately. The XFT-2001D should be used with electrodes supplied by Shenzhen XFT Medical Limited.
- Page 6 Directions for Use Table 5 The stimulator should not be used while operating potentially dangerous equipment such as automobiles, power lawn mowers or large machinery. Abrupt changes in stimulation level could Recommended separation distance between portable and mobile create a hazard. RF communications equipment and the Nerve and Muscle Stimulator The XFT-2001D should not be worn or used while sleeping or bathing.
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Page 7: Introduction To Your Xft-2001D
Directions for Use Introduction to Your XFT-2001D Table 4 1. Introduction Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment XFT-2001D Foot Drop System is an advanced functional electrical stimulation (FES) device which brings remarkable effect on foot drop patient. Dropped-foot patient due to central nervous system injuries, such as Stroke, Incomplete Spinal Cord Injury, Traumatic Brain Injury, Cerebral Test Maximum... -
Page 8: Functions And Features
Directions for Use Directions for Use 3. Functions and Features Note1: At 80MHz and 800MHz, the higher frequency range applies. Bluetooth 4.0, more stable and reliable data transmission, easy operation and setting. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refection from structures, objects and people. -
Page 9: Components Of Your Xft-2001D
Directions for Use Directions for Use Components of Your XFT-2001D Table 3 1. Components Guidance and manufacture's declaration – electromagnetic immunity XFT-2001D Foot Drop System patient kit mainly consists of the following parts: This equipment should be used in the electromagnetic environment specified below. User should assure that it is used in such an environment. -
Page 10: Stim Unit & Cuff
Directions for Use Directions for Use Table 2 2. Stim Unit & Cuff Guidance and manufacture's declaration – electromagnetic immunity Stim Unit This equipment is intended for use in the electromagnetic environment specified below. User snap button should assure that it is used in such an environment. Electromagnetic Immunity test Compliance level... -
Page 11: Quick-Fit Electrode
Directions for Use Directions for Use 3. Quick-fit Electrode Electromagnetic Compatibility (EMC) Declaration of Conformity to R&TTE Directive 1999/5/EC The Bluetooth Module in the XFT-2001D is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. The following standards were applied during the assessment of the product against the requirements of the Directive 1999/5/EC: Radio Spectrum: ETSI EN 300 328 V1.8.1 (2012-06) EMC: ETSI EN 301 489-1 V1.9.2 (2011-09) ETSI EN 301 489-17 V2.2.1 (2012-09) -
Page 12: Remote Control
Directions for Use Directions for Use Configurations 4. Remote Control OLED Screen Stim Unit 1 pc Power Button Micro USB Port Right Button Left Button Set/Enter Intensity Decrease Intensity Increase Cuff 1 pc Play/Pause/Back Mode/ Unlock Switch 1 pc Remote Control Quick-fit Electrode 2 pcs Buttons... -
Page 13: Daily Use Of Your Xft-2001D
Directions for Use Directions for Use Power adapter Daily Use of Your XFT-2001D Input AC100-240V, 50-60Hz, 0.3A 1. Charging for Stim Unit and Remote Control Output DC5V, 1.2A 1) Charging for Stim Unit Size 71 x 41 x 31.5mm When the Stim Unit is in low battery, connect it to power adapter. The indicator on Stim Unit will turn red in charging, and it will turn green when charging is complete. -
Page 14: Use With Quick-Fit Electrode Or Gel Electrode
Directions for Use Directions for Use 2. Use with Quick-fit Electrode or Gel Electrode Specifications The product has Quick-fit Electrode and Gel Electrode, patients can choose according to their needs. Communication: Bluetooth 4.0 Communication band: 2.4-2.4835 Ghz 2.1 Use with Quick-fit Electrode Modulation type: GFSK Effective radiated power: +4dBm Stim Unit... -
Page 15: Wear The Product
Directions for Use Directions for Use 3. Wear the Product Frequently Asked Questions 1) Preparation 1. The stimulation is weak. a) Skin care: to achieve an ideal effect of stimulation, please use wet towel to clean the skin of the leg. a. -
Page 16: Steps For Use
Directions for Use Directions for Use Care and Maintenance Steps for Use 1. Stim Unit and Cuff Stim Unit As the electrical components are not waterproof, please do not immerse the Stim Unit Use Foot Drop System in water.Please use a soft cloth with neutral detergent or alcohol to wipe the surface of the Stim Unit. -
Page 17: Gait Mode
Directions for Use Directions for Use Gait mode Training mode Gait mode is an active rehabilitation training mode, which provides rehabilitation electrical Training mode is suitable for patients who lack of active training, patients lay or sit down during stimulation while walking; the training.
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