XFT Medical G4 User Manual Download Page 4

 

Warning 

 

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 or menstruation has not been determined. 

 

Electrode positioning and stimulation parameters’ setting should be conducted by professionals. If you keep feeling pains or 

rash, please stop using this product. 

 

Please do not position the electrode in the area of malignant neoplasms, neck arteries (throat) or thrombus. 

 

Be careful if the electrode positioning areas show following situations: 

– 

Bleeding trend caused by serious trauma; 

– 

Muscle training might cause disorder of rehabilitation of a recent surgery; 

– 

Electrode positioning areas are not sensitive enough. 

 

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 when the output current density exceeds 10mA/cm

2

 (r.m.s). 

 

Please use with caution if the used areas have structural deformity. 

 

This product should be conducted by doctors. 

 

Patients should keep stable and not move while using this unit. 

 

Patients should not move the electrode or be touched while using this unit. 

 

Please stop using this product if the body shows any physical abnormality. 

 

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not 

cause harmful interference, and (2) this device must accept any interference received, including interference that may cause 

undesired operation. 

 

FCC warning: 

Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to 

operate the equipment. 

  

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the 

FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. 

This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the 

instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not 

occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be 

determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the 

following measures: 

-Reorient or relocate the receiving antenna. 

-Increase the separation between the equipment and receiver. 

-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 

-Consult the dealer or an experienced radio/TV technician for help. 

  

Summary of Contents for G4

Page 1: ...Foot Drop System User Manual Caution Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he she practices to use or order the use...

Page 2: ...and Safety 3 2 Overviews 8 3 Product Illustration 9 4 Operation Instruction 12 5 Attentions 17 6 Care and Maintenance 17 7 FAQ Troubleshooting 18 8 Product Configuration 18 9 Product classification 19...

Page 3: ...the device battery accessory packing in accordance with the legal obligation in your area Contraindications Powered muscle stimulators should not be used on patients with cardiac demand pacemakers Do...

Page 4: ...ds 10mA cm2 r m s Please use with caution if the used areas have structural deformity This product should be conducted by doctors Patients should keep stable and not move while using this unit Patient...

Page 5: ...ctions may put the user at undue risk of injury Adverse Reactions Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators Electromagnetic Compati...

Page 6: ...is used in such an environment Immunity test IEC60601 test level Compliance Guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8kV air 6kV contact 8kV air Floors should be wood concrete or...

Page 7: ...ermined by an electromagnetic site survey a should be less than the compliance level in each frequency range b interference may occur in the vicinity of equipment marked with the following symbol Radi...

Page 8: ...s the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord During the swing phase of walking the XFT 2001EA electrically stimulates th...

Page 9: ...for 1 4 hours a day every morning and evening 20 minutes each time 3rd week later Walk for 4 8 hours a day every morning and evening 20 minutes each time Note take off the cuff for 15 minutes after e...

Page 10: ...working states of the unit such as gait mode training mode electrode loose low battery icon electrical stimulation output icon electrical stimulation intensity etc 3 2 2 Indicators Power on indicatio...

Page 11: ...is low there will be a battery icon display battery display zero capacity at low voltage and flash at 1 second interval When the battery voltage is as low as the shutdown voltage the unit automaticall...

Page 12: ...When the Stim Unit is in the pause state press the Electrical Stimulation Intensity Adjustment Button to activate the electrical stimulation intensity press the up button to increase the electrical st...

Page 13: ...stool relax the affected leg and bend naturally Place the Stim Unit to correct position under the knee 4 1 3 3 Power on and operate Turn on Press and hold the switch mode composite button for 2 secon...

Page 14: ...it receives a reply from the Stim Unit and pauses the walk Continue The App sends the gait mode start at which time the current intensity given in the parameter setting is the current intensity before...

Page 15: ...lation stop the electrical stimulation by the release and continue to hold the electrical stimulation for continuous output The parameters that can be adjusted are the electrical stimulation intensity...

Page 16: ...pp sends an evaluation mode to start the command to the Stim Unit receives the Stim Unit reply and enters the evaluation work interface Stop After long press and stop for 2s send the evaluation mode s...

Page 17: ...in Care Before and after using the device please examine the skin it is normal that skin slightly turns red which shows faster blood flow Allergy Prevention Advice Do not position on the skin with mak...

Page 18: ...ng to use the device Remember to regularly ventilate the skin covered by the Stim Unit Q4 The unit display battery icon is turned off after 1 second interval flashing A This indicates that the Stim Un...

Page 19: ...ed 8 5 Product configuration Stim Unit 1pc Power Adapter 1set User manual 1pc 9 Product classification a Classified by type of electric shock internal power supply b The application part is classified...

Page 20: ...epaired 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 21: ...trasse 80 D 20537 Hamburg Germany US Agent Yang LingYun 605 Sherwood Forest Place Cary North Carolina Cary NC 27519 Phone 919 4751044 Ext Email Usagency 126 Com Date 2018 12 17 Doc No XFT 2001EA E Ver...

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