2AS2I2003EANerve and Muscle Stimulator

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. 2/42 Content 1. For Your Health and Safety........................................................................................................................4 2. Overviews...................................................................................................................................................7 3. Product 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.................................................................................................................33 11. Electromagnetic Compatibility (EMC).................................................................................................34 12. After-Sale Service.................................................................................................................................40 3/42 Glossary EMG: Electromyography, it is an electro diagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal 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 the elicitation of muscle contraction using electric impulses. ETS: EMG triggered electrical stimulation. PAS: Power assistant stimulation. UE: Upper Extremity 4/42 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 injuries caused by inappropriate use and are categorized into sections of: danger, warning and attention.  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 Use with Caution 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 IPX6The protection level against water is IPX6 Temperature limit 5/42 Humidity limitation Atmospheric pressure limitation Contraindications Do not use the device where a cancerous lesion in present or suspected. Do not use the device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Use of the device in conjunction with any of the above may cause electric shock, burns, electrical interference, or death.  Do not use the device on an arm where a regional disorder, such as a fracture or dislocation, would be adversely affected by motion from the stimulation. Warning  Do not use the XFT-2003EA while receiving any MRI scan.  Do not use the XFT-2003EA while sleeping, bathing or operating a vehicle.  The long-term effects of chronic electrical stimulation are unknown.  Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation should not be applied transthoracically 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, thrombophlebitis, varicose veins, etc. Stimulation should not be applied over, or in proximity to, cancerous lesions.  The safety of usage during pregnancy has not been determined.  Electrode positioning and stimulation parameters’ setting should be conducted by professionals. If you keep feeling uncomfortable stimulation or experience a skin irritation or rash please stop using this product.  Please do not position the electrode in the area of malignant neoplasms, neck arteries (throat) or thrombus.  Please do not position the electrode on the affected skin or other affected area, such as fracture and dislocation. Please use with caution when the arteries of used area show partial occlusion, when the patient has vascular atrophy because of hemodialysis, or when the vascular system shows instability. Please use with caution if the used areas have structural defor…

Text truncated - open the document above for the full version.

2AS2I2003EA

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 6 External Photos for SZEM2007006701CR FCC ID: 2AS2I2003EA SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 6 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 6 of 6

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 6 Internal Photos for SZEM2007006701CR FCC ID: 2AS2I2003EA SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 6 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 6 Antenna SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 6 of 6

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700670103 Page: 1 of 6 Keny Xu EMC Laboratory Manager 1 Cover page SAR Evaluation Report Application No.: SZEM2007006701CR Applicant: Shenzhen XFT Medical Limited Address of Applicant: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Manufacturer: Shenzhen XFT Medical Limited Address of Manufacturer: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Factory: Shenzhen XFT Medical Limited Address of Factory: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Equipment Under Test (EUT): EUT Name: Nerve and Muscle Stimulator Model No.: XFT-2003EA FCC ID: 2AS2I2003EA Standards: 47 CFR Part 1.1307 47 CFR Part 2.1093 KDB447498D01 General RF Exposure Guidance v06 Date of Receipt: 2020-07-20 Date of Test: 2020-07-21 to 2020-08-10 Date of Issue: 2020-08-11 Test Result : Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700670103 Page: 2 of 6 2 Version Revision Record Version Chapter Date Modifier Remark 01 2020-08-11 Original Authorized for issue by: Damon Su /Project Engineer Eric Fu /Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700670103 Page: 3 of 6 3 Contents Page 1 COVER PAGE ........................................................................................................................................ 1 2 VERSION ................................................................................................................................................ 2 3 CONTENTS ............................................................................................................................................ 3 4 GENERAL INFORMATION ..................................................................................................................... 4 4.1 GENERAL DESCRIPTION OF EUT ......................................................................................................... 4 4.2 TEST LOCATION ................................................................................................................................ 5 4.3 TEST FACILITY .................................................................................................................................. 5 4.4 DEVIATION FROM STANDARDS ............................................................................................................ 5 4.5 ABNORMALITIES FROM STANDARD CONDITIONS .................................................................................... 5 4.6 OTHER INFORMATION REQUESTED BY THE CUSTOMER .......................................................................... 5 5 SAR EVALUATION ................................................................................................................................. 6 5.1 RF EXPOSURE COMPLIANCE REQUIREMENT ........................................................................................ 6 5.1.1 Standard Requirement ................................................................................................................ 6 5.1.2 Limits .......................................................................................................................................... 6 5.1.3 EUT RF Exposure ....................................................................................................................... 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700670103 Page: 4 of 6 4 General Information 4.1 General Description of EUT Test voltage: DC 7.4V Power adapter: AC/DC Adapter Model: GTM46101-1005-USB Input: AC 100-240V, 50/60Hz, 0.3A Output: DC 5V, 2.0A Battery: Rechargeable Lithium Battery 7.4V Operation Frequency: 2402MHz to 2480MHz Bluetooth Version: V4.0 Modulation Type: GFSK Number of Channels: 40 Channel Spacing: 2MHz Antenna Type: Ceramic Antenna Antenna Gain: 2.0dBi SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700670103 Page: 5 of 6 4.2 Test Location All tests were performed at: SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch No. 1 Workshop, M-10, Middle section, Science & Technology Park, Shenzhen, Guangdong, China 518057 Telephone: +86 (0) 755 2601 2053 Fax: +86 (0) 755 2671 0594 No tests were sub-contracted. 4.3 Test Facility The test facility is recognized, certified, or accredited by the following organizations: • A2LA (Certificate No. 3816.01) SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory is accredited by the American Association for Laboratory Accreditation(A2LA). Certificate No. 3816.01. • VCCI The 3m Fully-anechoic chamber for above 1GHz, 10m Semi-anechoic chamber for below 1GHz, Shielded Room for Mains Port Conducted Interference Measurement and Telecommunication Port Conducted Interference Measurement of SGS-CSTC Standards Technical Services Co., Ltd. have been registered in accordance with the Regulations for Voluntary Control Measures with Registration No.: G-20026, R-14188, C-12383 and T-11153 respectively. • FCC –Designation Number: CN1178 SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory has been recognized as an accredited testing laboratory. Designation Number: CN1178. Test Firm Registration Number: 406779. • Innovation, Science and Economic Development Canada SGS-CSTC Standards Technical Services Co., Ltd., Shenzhen EMC Laboratory has been recognized by ISED as an accredited testing laboratory. CAB identifier: CN0006. IC#: 4620C. 4.4 Deviation from Standards None. 4.5 Abnormalities from Standard Conditions None. 4.6 Other Information Requested by the Customer None. SGS-CSTC Standards Technical Services Co.,…

Text truncated - open the document above for the full version.

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 3 Setup Photos for SZEM2007006701CR FCC ID: 2AS2I2003EA SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 3 1 Photographs Radiated Emissions which fall in the restricted bands SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 3 Radiated Spurious Emissions