XFT Medical G4 Скачать руководство пользователя страница 6

 

  Table 1 

MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSION 

 

This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in 
such an environment.   

Emissions test   

Compliance 

Electromagnetic 

Environment - Guidance 

RF emissions,   

CISPR 11 

Group 1 

This equipment uses RF energy only for its internal function. Its RF 
emissions are very low and are not likely to cause any interference in 
nearby electronic. 

RF emissions,   

CISPR 11 

Class B 

This equipment is suitable for domestic establishments and those 

directly connected to the public low-voltage power supply network. 

Harmonic emissions,   

IEC 61000-3-2 

Class A 

Voltage fluctuations/flicker 
emissions,   

IEC 61000-3-3 

Complied   

 

Table 2 

MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSION

 

This equipment is intended for use in the electromagnetic environment specified below. User should assure that it 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 ceramic tile. 

Humidity should be at least 30% if it is synthetic 

materials. 

Electrical fast 

transient burst 

(EFT) 

IEC 61000-4-4 

±2kV power lines 

±1kV I/O electric cable 

(length>3m) 

±2kV power lines 

Main power quality should be that of a typical 

commercial or hospital environment. 

Surge 

IEC 61000-4-5 

±1kV differential mode 

±2kV common mode 

±1kV differential 

mode 

±2kV common 

mode 

Voltage dips, 

short 

interruptions and 

voltage variations            

IEC 61000-4-11 

<5% UT (>95% dip in 

UT) 0.5 cycle 

40% UT (60% dip in 

UT) 5 cycle 

70% UT (30% dip in 

UT) 25 cycle 

<5% UT (>95% dip in 

UT) 5s   

<5% UT (>95% dip 

in UT) 0.5 cycle 

40% UT (60% dip 

in UT) 5 cycle 

70% UT (30% dip 

in UT) 25 cycle 

<5% UT (>95% dip 

in UT) 5s 

Mains power quality should be typical commercial or 

hospital environment. UPS power is recommended if 

this device needs to be used continuously. 

Power frequency 

(50/60Hz) 

3 A/m 

3 A/m 

Power frequency 

magnetic fields should be at levels characteristic 

Содержание G4

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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