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table of contents

1.0

Intended Use

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Contraindications

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Warnings

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5.0

Precautions

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6.0

Adverse Reactions

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7.0

Unit Description

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8.0

Specifications

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TENS Stimulation Mode Descriptions

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Waveform Reference

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EMS Treatment Functions Descriptions

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Instructions For Use

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Patient Compliance Timer

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Care and Maintenance

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Troubleshooting

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Declarations-EMC

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Содержание FLEX-MT PLUS

Страница 1: ...Instruction Manual Please read the Instruction Manual prior to use CAUTION Federal law requires a prescription from your physician before use of this product ...

Страница 2: ...3504 Cragmont Dr Suite 100 Tampa FL 33619 P 800 588 8383 813 931 2369 F 800 588 9282 E customerservice wecontrolpain com ...

Страница 3: ...CAUTION Federal law requires a prescription from your physician before use of this product ...

Страница 4: ... Reactions 9 7 0 Unit Description 10 8 0 Specifications 13 9 0 TENS Stimulation Mode Descriptions 14 16 0 Waveform Reference 33 10 0 EMS Treatment Functions Descriptions 17 11 0 Instructions For Use 18 12 0 Patient Compliance Timer 24 13 0 Care and Maintenance 25 14 0 Troubleshooting 27 15 0 Declarations EMC 28 ...

Страница 5: ...retardation of disuse atrophy Prevention of venous thrombosis of the calf muscles immediately after surgery Maintaining or increase range of motion 2 0 page will show you how to use and care for your device in the general manner You should be particularly familiar with the prescription information and precautions before proceeding You should consult with your clinician if you have specific questio...

Страница 6: ...sinus reflex 3 Stimulation should not be applied over the front of neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may occur and may be strong enough to close the airway or cause difficulty in breathing 4 Stimulation should not be applied trans thoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias ...

Страница 7: ...such as ECG monitors and ECG alarms may not operate properly when TENS is in use 12 Apply the electrodes to clean dry and unbroken skin only 13 involuntary muscle contractions may put the user at undue risk of injury 14 15 16 17 TENS is a symptomatic treatment and as it suppresses the sensation of pain which would otherwise serve as a protective mechanism 7 ...

Страница 8: ...hen muscle contraction may disrupt the healing process c Over the menstruating or pregnant uterus and d Over areas of the skin which lack normal sensation 4 Some patients may experience skin irritation of hypersensitivity due to the electrical stimulation or medium or alternate electrode placement 5 Electrode placement and stimulation settings should be based on the guidance of the prescribing pra...

Страница 9: ...which themselves conform to the EMC regulations may influence the proper functioning of the device if such equipment is operated in close proximity and with relatively high transmitting power Flex MT Plus meets EMC requirements and is designed in such a way that under normal conditions there is no risk of malfunction caused by electromagnetic interference However in the case of signals from high f...

Страница 10: ...ENS or EMS stimulation modes SET Button Set the pulse width pulse rate ramp time on time and off time TIMER Button Sets the timer INCREASE DECREASE Button Increase and decrease pulse width pulse rate ramp time on time off time and choose the timer LOCK UNLOCK Button Locks or unlocks the unit Symmetric Asymmetric Button Choose symmetric or asymmetric waveform ...

Страница 11: ...LCD Display 11 Recharger Receptacle ...

Страница 12: ...female connection are provided with the Flex MT Plus Each output jack of the device is designed to accept a lead wire whose connector complies with FDA 21 CFR Part 898 requirements The Flex MT Plus is recommended for use with the previously cleared Everlife self adhesive electrodes Re order information on page 26 Battery Charger Input AC 110V 50 60Hz 0 2A Output DC 4 8V 400mA Accessories 12 ...

Страница 13: ...ding 1000Ω Level 1 Level 20 Each level increases 3 25V 0 65V Loading 1000Ω 65mA Loading 1000Ω Level 1 20 Each level increases 3 25V Variable 50 400 µs Variable 2 150 Hz 1 99 seconds 1 99 seconds Output Peak Pulse Output Level Output Peak Pulse Output Level Channel Power Source Output waveform Symmetric Asymmetric Pulse Width Pulse Frequency All values or 10 On Time Off Time EMS only ...

Страница 14: ...total time max with 999 hrs Operation ambient Temperature range 10 C 35 C Humidity range 20 90 RH Storage transportation Temperature Range 0 C 70 C Humidity Range 20 90 RH Timer 5 90 minutes auto shutoff or Constant Size L 120mm x W 54mm x H 33mm Weight 156 grams including battery 9 0 TENS Stimulation Mode Descriptions button Be sure that when adjusting these stimulation modes the intensity output...

Страница 15: ...nd pulse width form 50 to 400μs are fully adjustable The normal Modulated Rate Width MRW massage like sensation It s believed that nerves can become accustomed to or ac commodated to the same electrical stimulus after a period of time and thus would produced to offer a variety of different electrical stimulation thus preventing nerve accommodation so that less intensity is required for long and ef...

Страница 16: ...s 6 seconds Pulse rate from 2 to 150Hz and pulse width from 50 to 400µs are fully adjustable Bi Pulse Bi Pulse pulse rate of Channel 1 is fixed at 4Hz while delivering 100 pulses per second to Channel 2 i e the pulse rate of Channel 2 is fixed at 100Hz Stimulation vertical line Pulse width from 50 to 400 µs is fully adjustable 9 0 TENS Stimulation Mode Descriptions continued TENS Mode ...

Страница 17: ...MODE Interpretations Alternative A vated Channel 2 will be inactivated and vice versa Synchronous S duration is controlled by ON TIME and OFF TIME 10 0 EMS Treatment Functions Descriptions 17 ...

Страница 18: ...nate and alternately flash as it is being charged If red or flashing red check battery for proper placement If not solved call customer serviec When charging is done usually 3 4 hours on a fully discharged battery a green steady light will illuminate Typical charge may last several hours of use depending on frequency and intensity of treatment NOTE The device will NOT work if the charger is plugge...

Страница 19: ...r both channels with two pairs of lead wires Caution Always use leadwires that came with the unit Using other leadwires may render the unit non operable and void the warranty 2 The Flex MT Plus is compatible and recommended for use with EMSI electrodes or comparable Always use electrodes and leadwires that came with the unit Using other electrodes and leadwires may render the unit non operable ine...

Страница 20: ...rn unit on Activated Controls will be visible on LCD screen Press Mode to select appropriate stimulation mode 5 TENS Options 2 EMS options Press Set to select unit output for the following as directed by clinician pulse width pulse rate ramp time on time and off time adjust to the desired setting by pressing the triangular increase decrease button Choose Symmetric or Asymmetric waveform by pressin...

Страница 21: ... the treatment by pressing and holding the key button for 3 seconds a beep if enabled will confirm device is locked The device also automatically locks if no treatment button is pressed for 1 minute Once locked other than the power button no buttons are active To disable the Lock during treatment session for adjustment or stoppage press and hold the key button for 3 seconds a beep will confirm dev...

Страница 22: ...il you canfeel the tingling sensation high pulse rates or pulsing sensation low pulse rates of the stimulation Your prescr bingclinicianwilltell you how far they wish you to turn up the intensity If at any time the electrical stimulation begins to feel uncomfortable reduce the stimulation amplitude to a comfortable level and contact your physician if the problem persist possibility of electromagne...

Страница 23: ...vel Start to Operate Choose MODE TENS or EMS Choose Symmetric or Asymmetric waveform Press MODE Button Press and hold both Negative Amplitude Button SET ADJUST CLOCK ADJUST Amplitude Control BEEP OPTION press and hold SET button to activate deactivate Set Parameter Rate Width etc Press Symmetric Asymmetric Button 23 ...

Страница 24: ...and hold Set button for 3 seconds to delete the displayed record After the displayed record is deleted the unit will acknowledge with an audible response Bi NOTE a If the treatment time is under one minute it will not be recorded For example if your treatment time is 10 minutes and 30 seconds the patient compliance timer will record 10 minutes not 11 minutes use the stimulator for over 999 minutes...

Страница 25: ...treatment time record The patient compliance timer will keep the records even when the battery has no charge Only when users press and hold Set or Mode Set the records will be deleted 13 0 Care and Maintenance 1 Low Battery Indicator When the low battery indicator flashes the battery should be recharged as soon as possible 2 Cleaning Clean the housing by wiping with clean damp cloth only To avoid ...

Страница 26: ...ease contact EMSI Customer Service at Phone 800 588 8383 813 931 2369 E mail customerservice wecontrolpain com Specify the unit type is Flex MT Plus Stimulator and the electrode size recommended by your ordering clinician 26 13 0 Care and Maintenance continued ...

Страница 27: ...properly Low Battery indicator flash 2 Are electrodes in proper position and adhering to the skin See Section 11 Instructions for Use and the electrode manufactures instruction for applying the electrodes 3 Check lead wires Be sure all connectors are firmly sealed See Section 11 Instructions for Use Item 3 4 Replace cord set with another to check for broken wires Recharge battery pack 1 Check all ...

Страница 28: ...stomer or the user of the Flex MT Plus should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance The Flex MT Plus is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes The Flex MT Plus uses RF e...

Страница 29: ...unity The Flex MT Plus is intended for use in the electromagnetic environment specified below The customer or the user of the Flex MT Plus should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 29 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity s...

Страница 30: ...l Electromagnetic environment guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the Flex MT Plus requires continued operation during power mains interruptions it is recommended that the Flex MT Plus be powered from an uninterruptible power supply or a battery 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT ...

Страница 31: ...rs as determined 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 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from s...

Страница 32: ...communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 32 0 01 0 1 1 10 100 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the ...

Страница 33: ...33 TENS 500Ω Loading 1 B Burst Symmetric Asymmetric Multi Pulse Waveform 16 0 Waveform Reference ...

Страница 34: ...34 2 N Normal Symmetric Single Pulse Waveform Multi Pulse Waveform Asymmetric ...

Страница 35: ...35 3 MRW Modulated Rate Width Symmetric Single Pulse Waveform MAX Rate min Width Asymmetric Multi Pulse Waveform MAX Rate min Width ...

Страница 36: ...36 4 SD Strength Duration Symmetric Single Pulse Waveform Max Width min Intensity Multi Pulse Waveform Max Width min Intensity Asymmetric ...

Страница 37: ...37 5 Bi Bi Pulse Symmetric Single Pulse Waveform Channel 1 Multi Pulse Waveform Channel 1 Asymmetric ...

Страница 38: ...38 Symmetric Single Pulse Waveform Channel 2 Multi Pulse Waveform Channel 2 Asymmetric ...

Страница 39: ...39 Multi Pulse Waveform EMS 500Ω Loading A Alternate Symmetric Single Pulse Waveform Asymmetric ...

Страница 40: ...S Synchronous Symmetric Single Pulse Waveform Multi Pulse Waveform Asymmetric 40 ...

Страница 41: ...arranted against defect or workmanship for this period This warranty is voided if this product has been damaged by misuse abuse neglect or otherwise used in a manner not suited or prescribed for this product This warranty is voided with use of unapproved electrodes lead wires chargers or batteries This warranty does not cover what is considered to be normal wear and tear replacement of batteries l...

Страница 42: ...a prescription from your physician before use of this product 3504 Cragmont Dr Suite 100 Tampa FL 33619 P 800 588 8383 813 931 2369 F 800 588 9282 E customerservice wecontrolpain com Copyright 2016 by EMSI All Rights Reserved REV B ...

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