Everyway Comfy EMS Manual de usuario

0434

Comfy EMS R

FOR THE

INSTRUCTION MANUAL

Distributed by:

V1.1

INDEX

1. Introduction .......................................................... 1

2. Cautions ................................................................ 3

3. Warnings ............................................................... 4

4. Contraindication ................................................... 5

5. Adverse Reactions ............................................... 5

6. General Description ............................................. 5

7. Construction ......................................................... 6

8. Technical Specifications ...................................... 8

9. Replaceable Parts................................................. 10

10. Accessories.......................................................... 10

11. Graphic Symbols .................................................. 11

12. Operating Instructions......................................... 11

13. AttachmentofElectrodes Lead Wires ............... 12

14. Lead Wire Maintenance ....................................... 13

15. Electrode Options ................................................. 13

16. Electrode Placement ............................................ 13

17. Tips For Skin Care ................................................ 14

18. Application of Re-usable Self

Adhesive Electrodes ............................................ 15

19. Adjusting the Controls ........................................ 16

20. BatteryInformation .............................................. 22

21. Maintenance, Transportation and Storage ......... 23

22. SafetyControl ....................................................... 24

23. Malfunctions ......................................................... 24

24. Conformityto SafetyStandards.......................... 25

25. Warranty ................................................................ 25

Manufacturer ....................................................... 25

Representative in the EU..................................... 25

Appendix .............................................................. 26

Chapter Contents Page

IMPORTANT SAFETY INFORMATION

Read instruction manual beforeoperation. Be suretocomplywith all

CAUTIONS”and WARNINGS”in the manual. Failure to followin-

structionscan cause harmtouser or device.

Chapter 2: CAUTIONS

1. Federal law(USA) restricts this device to sale by or on the order

ofaphysician

2. Safety of powered musclestimulators for use during pregnancy

has notbeen established.

3. Caution shouldbe used for patientswith suspected or diagno-

sed heart problems.

4. Caution shouldbe used for patientswithsuspected or diag no-

sed epilepsy.

5. Caution shouldbe used in the presenceof the following:

a.Whenthereisa tendencytohemorrhage followingacutetrauma

orfracture;

b.Following recentsurgicalprocedureswhen musclecontrac-

tion may disrupt the healing process;

c.Over the menstruating or pregnant uterus; and

d.Over areas of the skin whichlack normal sensation.

6. Somepatients may experience skin irritation or hypersensitivity

due to the electrical stimulation or electrical conductive medium.

The irritation can usually be reduced by using an alternate con-

ductive medium, or alternate electrode placement.

7. Electrode placement and stimulation settings shouldbebasedon

the guidanceof the prescribing practitioner.

8. Powered muscle stimulators shouldbe kept out of the reachof

children.

Chapter1: INTRODUCTION

EXPLANATION OF EMS

ElectricalMuscleStimulationisan internationally accepted and proven

wayoftreatingmuscularinjuries. Itworks bysendingelectronic

pulses tothe muscle needing treatment; thiscauses the muscleto

exercise passively.

It is a product derived fromthe square waveform, originally invented

by John Faraday in 1831. Through the square wave pattern it is able

towork directly on muscle motor neurons. TheComfy EMS has low

frequencyand this in conjunction with the square wave pattern

allows direct work on musclegroupings. This is being widely used in

hospitals andsports clinicsfor the treatmentofmuscular injuries

and for the re-education of paralyzed muscles, to prevent atrophy in

affected muscles and improving muscle tone and blood circulation.

HOW EMS WORKS

1. Relaxation of muscle spasms

2. Prevention or retardation of disuse atrophy

3. Increasing local blood circulation

4. Musclere-education

5. Immediate post-surgical stimulation of calf muscles to prevent

venousthrombosis

6. Maintaining or increasing range of motion

TheEMSunits send comfortableimpulsesthrough the skinthat stimu-

late thenerves in the treatment area. When the muscle receives this

signalit contractsasifthe brainhas sentthe signalitself. Asthe

signal strength increases, the muscle flexes as in physical exercise.

Then when the pulse ceases, the muscle relaxesand the cycle

starts over again,(Stimulation,Contraction and Relaxation.)Pow-

ered muscle stimulators should only be used under medical supervi-

sion for adjunctivetherapy forthetreatment of medicaldiseases

and conditions.

Chapter4: CONTRAINDICATION

Poweredmusclestimulatorsshould not beused on patientswith

cardiacdemand pacemakers.

Chapter 5:ADVERSE REACTIONS

Skin irritation and burns beneath the electrodes have been reported

with the use of powered muscle stimulators. If skin irritation occurs,

discontinue useand consultyour physician

.Chapter 6:GENERAL DESCRIPTION

The Comfy EMS is a battery operated pulse generator that sends

electrical impulses through electrodes tothe body and reaches the

underlying nerves or muscle group. The device isprovided with two

controllableoutputchannels, eachindependent ofeachother.An

electrode pair can be connected to eachoutput channel.

The electronics of the Comfy EMS create electricalimpulseswhose

Intensity, Pulse Width, Pulse Rate,Contraction,RelaxationandRamp

may be altered withthe switches.Press buttonsare very easyto

use and the panelcover prevents accidental changes in the setting.

9. Powered muscle stimulators shouldbe used only with the leads

and electrodes recommended for useby the manufacturer.

10.Portable powered muscle stimulators shouldnot be used while

driving, operating machinery, or during any activityinwhichin-

voluntary muscle contractions may putthe user at undue risk of

injury.

Chapter 3: WARNINGS

1. The long-term effects of chronic electrical stimulation are

unknown.

2. Stimulation should not be applied over the carotid sinus nerves,

particularlyinpatientswithaknown sensitivity to the carotid

sinusreflex.

3. Stimulation should not be applied over the neck or mouth. Severe

spasm of the laryngeal and pharyngeal musclesmay occur and

the contractionsmay be strong enough toclose the airway or

cause difficulty in breathing.

4. Stimulation should not be applied transthoracically in that the in-

troduction of electrical current intothe heart may causecardiac

arrhythmias.

5. Stimulation should not be applied transcerebrally.

6. Stimulation should not be applied over swollen, infected, or in-

flamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,

varicoseveins, etc.

7. Stimulation should not be applied over, or in proximity to, cancer-

ouslesions.

BACK

(9) BATTERYSTRIP

(10) BATTERYCASE

(11) BELTCLIP

SIDE

(12) PROTECTIVE COVER

BACK SIDE

FRONT

(1)LIQUIDCRYSTICALDISPLAY

(2)PANELCOVER

(3)LEADCONNECTOR

(4)INTENSITY CONTROL

(ON/OFF SWITCH)

(5)MODECONTROL

(6)SET CONTROL

(7)INCREMENTCONTROL

(8)DECREMENTCONTROL

Chapter 7 : CONSTRUCTION

16 Synchronous Stimulation of both channelsoccurs

synchronously. The ON”time including

Ramp Up”and Ramp Down”time.

Therefore,the setting of ONTime shouldbe

noless thantwotimes ofthe Ramp”time in

this mode.

ONTIME ≥Rampup+Rampdown

17 Alternate The stimulation ofthe CH2 will occur after

the 1st contraction of CH1 is completed. In

this mode, the setting of ONTime shouldbe

no less than two times of the Ramp”time.

TheOFFTime should beequalormorethan

theONTime.

ONTIME ≥Rampup+Rampdown

OFFTIME≥ONTIME

18 ComplianceMeter This unitcan store 60 sets of operation

records.Total recorded timeis999 hours.

19 LowBattery A low battery indicator willshow up on the

Indicator LCD when battery is low.

20 Operating Temperature:0°~40

Condition RelativeHumidty:30%~75%

Atmosphere Pressure : 700Hpa~1060Hpa

21 Tolerance There may be a +/-5% tolerance of all

settings and +/-20% tolerance of output

amplitudeand voltage.

Chapter 8: TECHNICAL SPECIFICATION

The technicalspecification details of Comfy EMS are as follows.

MECHANISM TECHICALDESCRIPTION

01 Channel Dual,isolated between channels

02 PulseAmplitude Adjustable 0-100mA into500 ohmload each

channel.

03 Output Voltage Adjustable0-50V, Maxoutput 50V peak to

peak into 500ohmload each channel.

04 Wave Form Asymmetrical rectangular biphasic pulse.

05 Power Supply One 9 VoltBattery,type 6F22

06 Size 10.1cm(L) x6.1cm(W)x2.45cm(H)

07 Weight 150 grams (battery included)

08 OnTime Adjustable, 2~90 seconds ,1Sec./step

09 Off Time Adjustable, 0~90 seconds ,1Sec./step

10 RampTime Adjustable, 1~8 seconds, 1 Sec./ step, The

On”time will increase and decrease in the

setting value.

11 Pulse Rate Adjustable, 2~150 Hz , 1Hz / step

12 PulseWidth Adjustable,50~300µs , 10µs/ step

13 Timer Adjustable, 1-60 minutes or Continuous.

Adjustable in 1 minute each step from

1 to 15 minutes, and 5 minutes each step

from15 to 60minutes. Treament time

countdown automatically.

14 OutputMode Constant,Synchronous,Alternate

15 Constant Constantstimulationbased on settingvalue.

Only pulse width, pulse rate and timer are

adjustable inthismode. Constant”is equal

tothe Normal”mode of a TENSunit.

1110

II. LABEL Thelabel attachedto theback of de-

vicecontains important information

abou tthisdevice-model name,serial

number(started withmanufacturing

year and weekof the device),supplyvoltage, nameof the

manufacturer, CE number and classification. Please do not remove.

Chapter 11: GRAPHIC SYMBOLS

1. Degreeof Electrical Protection BF

2. Do notinsert the plug intoAC power supply socket

3. Direct Current(DC power source)

4. Timer

5. LowBattery

6. Increment

7. Decrement

8. Consult Instructions for use

9. Manufacturer

10. Serial Number

Chapter 12: OPERATING INSTRUCTIONS

1) Insert the 9V battery into the device’sbattery compartment.

Make sure to remove the plastic seal on the 9V battery. Line up

the positive and negative terminals on the battery with their cor-

responding terminals in the device. Make sure that both Intensity

control (ON/OFF Switch) knobs are inthe off position.

2) Insert the lead wiresintothe lead wire socketson top of the

device.

3) Open the electrode package. Then insert each lead wire pin into

the pigtail of the electrodes

Chapter 9: REPLACEABLE PARTS

The replaceable parts and accessories of ComfyEMS devices are

asgivenbelow:

Except leads, electrodes,battery and battery case cover,please do

nottry toreplacethe other partsof adevice.

PARTS

01 LEADWIRES

02 ELECTRODES

03 9VBATTERY ,TYPE 6F22

04 BELTCLIP

05 BATTERYCASECOVER

06 LEADCONNECTOR

07 MAINPCB

08 INTENSITY KNOB

09 LCDCOVER

10 INTENSITY CONTROLCOVER

Chapter 10: ACCESSORIES

Each Comfy EMS comes complete with standard accessories and

the standard labelsas given below:

I. Accessories

REF.NO. PRODUCT Q’TY

KF4040 40 X40 mm Adhesive Electrodes 4 pieces

KB-24 Electrodes Leads 2 pieces

GC-01 9 VBattery 1 piece

Instruction Manual 1 piece

Carrying Case 1 piece

1312

CAUTION

Donot insert theplugofthepatient leadwireintotheACpower

supplysocket.

Chapter 14: LEAD WIRE MAINTENANCE

Clean the wiresby wiping with adampcloth.Coating them lightly

withtalcumpowder willreducetangling and prolong life.

Chapter 15: ELECTRODE OPTIONS

Theelectrodes aredisposableandshould beroutinely replaced

when they starttolosetheiradhesive nature.If you are unsure of

your electrode adhesive properties, order replacementelectrodes.

Replacement electrodes shouldbere-orderedthrough oronthe

advice of your physician to ensure proper quality. Follow application

proceduresoutlined inelectrode packing,to maintain optimal stimula-

tion and to prevent skin irritation.

Chapter16:ELECTRODEPLACEMENT

The placementof electrodes can be one of the mostimportant pa-

rameters in achieving success with EMS therapy. Of utmost impor-

tanceisthe willingnessof the physician to try the various styles of

electrode placement to find which method best fitsthe needs of the

individual patient.

Every patientresponds to electrical stimulation differentlyand their

needsmay vary from the conventionalsettings suggested here. If

theinitialresults are notpositive, speak toyourphysicianabout

alternative stimulation settings and/or electrode placements. Once

an acceptable placement has been achieved, mark down the elec-

trodes sitesand the settings,so thepatientcaneasily continue

treatment at home.

4) Placethe electrode on your body as directed by your physician.

5) Slowlyturn on the device by rotating the Intensitycontrol

(ON/OFF Switch) knobs.

6) Select the mode and settings as directed by your physician.

7) Slowlyincreaseor decreasethe intensityasdirected by your

physician by rotating the Intensity control (ON/OFF Switch) clock

wise toincrease,counter clockwisetodecrease. After

Treatment, Turn the device off by rotating the Intensity control

(ON/OFF Switch) counter clockwisetothe zero setting.

Chapter 13: ATTACHMENT OF ELECTRODE

LEAD WIRES

The wires provided with the system insert into the jack sockets

located on top ofthe device.Holding the insulatedportion of the

connector, pushthe plug end of the wire into one ofthe jacks (see

drawing);one or two setsofwires maybeused.

After connecting the wiresto the stimulator, attacheachwire to

an electrode. Use care when you plug and unplug the wires.

Jerking the wire instead of holding the insulated connector body

may causewire breakage.

1514

Chapter 18: APPLICATION OF RE-USABLE SELF

ADHESIVEELECTRODES

Application

1. Clean and dry the skin at the prescribed area thoroughlywith

soap and water prior toapplication ofelectrodes.

2. Insertthe lead wire intothe pinconnector on the pre-wired

electrodes.

3. Remove the electrodes fromthe protective liner and apply the

electrodes firmlyto the treatment site. Make surethat the unit is

turned offprior toapplying the electrodes.

Removal

1. Turn off the unit prior to removing the electrodes.

2. Lift at the edge of electrodesand peel; do not pullon the lead

wires becauseit may damage the electrodes.

3. Place the electrodes on the liner and remove the lead wire by

twisting and pulling at the same time.

Care and Storage

1. Between uses,store the electrodesinthe resealablebag ina

cool dry place.

2. It may be helpful to improve repeated application by spreading a

few drops of coldwater over the adhesive and turn the surface

up to airdry.Over Saturation withwater willreduce the adhe-

sive properties.

Chapter 17: TIPS FOR SKIN CARE

Toavoidskinirritation,especiallyif you have sensitive skin, follow

thesesuggestions:

1. Washthe area of skin where you will be placing the electrodes,

using mild soap and water before applying electrodes,and after

taking themoff. Be sure to rinse soap off thoroughly and dry skin

well.

2. Excesshairmay be clipped withscissors;do not shave stimula-

tion area.

3. Wipe the area withthe skin preparation your clinician has

recommended. Letthisdry.Apply electrodes as directed.

4. Many skin problems arisefromthe pulling stress”fromadhesive

patchesthatare excessivelystretched across the skinduring

application. Toprevent this, applyelectrodesfromcenteroutward;

avoidstretching over the skin.

5. Tominimize pulling stress”,tape extra lengths of lead wires to

the skinin a loop to prevent tugging on electrodes.

6. When removing electrodes, always remove by pulling in the di-

rection of hairgrowth.

7. It may be helpful to rub skin lotion on electrode placement area

whennotwearingelectrodes.

8. Never applyelectrodes over irritated or broken skin.

1716

3. Lead Connector

Connection ofthe electrodesismade withthe two lead wires.

The devicemustbe switched offbefore connecting the cables.

Both intensity controls must be at the Off -position. Electrodes

must be pressed firmly on the skin.

4. Mode Control

There are 3modes available –Constant,Synchronous and

Alternate.Amodecan be selectedbypressingthe Mode”control.

5. Set Control

By pressing the SET”control,you may enter the setting you

intend to make adjustment. You may start to set the value by

pressing the Increment”and Decrement”controlswhen the

value is flashing.

6. IncrementControl

This buttoncontrols theincreaseof settings. When pressing this

button, the parameter will increase.

Important

1. Do not apply to broken skin.

2. The electrodes should be discarded when they are no longer

adhering.

3. The electrodes are intended for single patientuseonly.

4. If irritation occurs, discontinue use and consultyour clinician.

5. Read the instructions for useofself-adhesive electrodes before

application.

Chapter 19: ADJUSTING THE CONTROLS

1. Panel Cover:

Alid coversthe controlsforselecting mode and adjustingsettings.

Your medical professional may wish to set these controlsfor you

and request that you leave the cover in place.

2. Power On/Off Switchand IntensityControls:

Ifbothcontrols are in the off-position, the device is switched off.

Byturning the controls clockwise, the appropriate channel is

switched on and the indicator ofpower (CH1 or CH2) will reveal

on the LCD.

The current strength of theimpulses transmitted to the electrodes

increasesfurther whenthe controlis turned clockwise.

Toreduce the current strengthor switchthe deviceoff, turn the

control counter clockwisetothe required setting or off-position,

respectively.The controls are protected by acap toavoid

unintentional change of intensity.

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