Everyway Comfy EMS User manual

0434
Comfy EMS R
FOR THE
INSTRUCTION MANUAL
INSTRUCTION MANUAL
Distributed by:
V1.1

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

32
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.

54
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.

76
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

98
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.

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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

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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.

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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.

1918
c.SetRampTime
The ramp time controlsthe time of outputcurrent thatincrease
from0 to the setting level, and fromthe setting value to 0.
When the ramp time is set, each contraction may be ramped
up and down in order that the signals come on and comeoff
gradually and smoothly. Theramp time is adjustable from1 to
8seconds.
d.SetOnTime
The On Time controls the time of stimulation. By pressingthe
SET”control,the contractiontimecan beadjusted. Both chan-
nels’stimulation is cycled on and off by the contraction and
relaxation settings.The range is adjustable from 2to 90
seconds.
As the ON”time including the ramp up and ramp down time,
the settingof it shouldbe noless thantwo timesof the Ramp”
time. (ON TIME ≥Ramp up+ Ramp down)
e.Set Off Time
The Off Time controlsthe time of relaxation. By pressing the
SET”control, the relaxation time can be adjusted. Bothchan-
nels’stimulation is cycled on and off by the contraction and
relaxation settings.The range is adjustable from 0 to 90
seconds.
InAlternate mode, the OFF Time shouldbeequalormorethan
theONTime.(OFFTIME≥ONTIME)
7. Decrement Control
This button controlsthe decrease of parameter. When pressing
this button, the parameter willdecrease.
8. Timer
The unit has a timer of 1-60 minutes and Continue. It can be
adjusted by pressing the Set”and Increment”or Decrement”
controls.The treatment timewill countdown in one minute
decrement.Its output will be shut offwhen timeis up.
9. Low Battery Indicator
Alow battery indicator willshowup on the liquidcrystal display
when the battery need to be replaced as soon as possilbe. It
may continue tooperatefor afew more hoursdepends on the
setting intensity level.
10.Steps to Set a NewProgram
The settings can be adjusted according tothe following steps.
Each setting will be stored in 2seconds after selected.
a. Turn on the Intensity
After the electrodes are placed firmly on skin and the lead
wiresare plugged inthe socketofdevice, turn the on/off
control clockwise. The liquidcrystal display will light up.
b. Select Mode
Select a mode by pressing the Mode”control. The mode you
selected willshowup on the top ofliquid crystal display.
When Constant”mode isselected, you can setonly pulse
width, pulse rate and timer later on. All parameters are adjust-
able on the Synchronous and Alternate mode.
After amode isselected, press SET”controltoenter next
setting. You may adjust the setting onlywhen the value is
flashing. Then press the Increment”or Decrement”control to
change the settings.

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11. PatientComplianceMeter
This unit can store 60 sets of operation records. Total treatment
time up to 999 hours can be stored.
Check & Delete Individual Records
Press Mode”control and turn on the power simultaneously.
The LCD will show the number of records and operation time.
Press the Increment”and Decrement button to check each
record. Todeletearecord, press SET”controlfor 3seconds.
Check & DeleteAccumulative Record
Atthe individual records menu, press Mode”control toswitch
to accumulative record menu. Press the SET”controlfirst, then
press the Mode”control simultaneouslyfor 3 seconds and all of
the recordswill be deleted followed by abeeper sound.
12. Check/Replace the Battery:
Over time, in order toensure the functional safety of the
Comfy EMS ,changing the battery is
necessary.
1. Make sure that both intensity controls are
switched tooff- position.
2. Slide the battery compartment cover and
remove.
3.Removethe battery fromthe compartment.
4. Insert the battery into the compartment.
5. Note the polarity indicated on the battery
and in the compartment.
6. Replace the battery compartment cover
and slide to close
f. Set Pulse Width
The pulse width determines the length of time. Each electrical
signal isapplied through the skin, whichcontrolsthe strength
and sensation of the stimulation. Press SET”control to enter
this setting. The pulse widthis adjustable from50 to 300 us.
g.SetPulse Rate
The pulse rate determines howmany electricalimpulses are
applied through the skin each second. Press SET”to enter
this menu. By pressing the increment and decrement controls,
the setting can be adjusted. The pulse rate is adjustable from
2 Hz to 150 Hz.
h.SetTimer
Press SET”to enterthis setting. The treatment time is adjust-
able from1 to 60 minutes or Continuous. It is increased in 1
minute each step from1 to 15 minutes, and 5 minutes each
step from15 to 60 minutes. Press Increment”or Decrement”
control toadjustsetting.Your settings will be
stored in this unit eternally unless they are adjusted again.
You can set the timer to Continuous”mode by pressing the
Increment”control when itshows60 minutes.
Continuous

2322
batteryhasbeen discharged,rechargeit assoonas possible.
If the battery is stored more than 60 days, it may need to be
recharged.
(c) Do not short the terminals of the battery. This will cause the
battery to get hot and can cause permanent damage. Avoid
storing the batteries in your pocket orpurse where the termi-
nalsmay accidentally come into contact with coins, keys or
any metal objects.
(d) WARNINGS:
1. Do not attempt tocharge any other types ofbatteries in
your charger, other than rechargeable batteriesmade for
your charger.Other types of batteries may leakor burst.
2. Donotincineratetherechargeablebattery asitmay explode!
Chapter 21: MAINTENANCE, TRANSPORTATION
ANDSTORAGE
1. Non-flammable cleaningsolution issuitable forcleaning the device.
Note:Donot smokeorworkwithopen lights (for example,candles,
etc.) when working withflammableliquids.
2. Stains and spots can be removed with a cleaning agent.
3.Do notsubmerge thedevice in liquids or exposeittolarge amounts
ofwater.
4. Return the devicetothe carrying box with sponge foamtoen-
sure that the unitiswell-protected before transportation.
5. If thedeviceisnot to beusedfor a longperiod of time, removethe
batteries fromthebattery compartment (acid may leak fromused
batteries and damage the device).Put the device and accesso-
ries in carrying boxand keep it incool dry place.
6. The packed Device should be stored and transported under the
temperature range of -20°C ~+60°C, relative humidity 20% ~5%
Aatmosphere pressure 500hPa~1060hPa.
Chapter 20: BATTERY INFORMATION
PRECATIONS
1.Removebatteryifequipmentisnot likelyto be usedfor some time.
2. Please recycle the used battery inaccordancewithdomestic
regulation.
3. Do not throwthe used battery intofire.
Ifyou use rechargeable batteries, pleasefollowthe instructions.
RECHARGEABLE BATTERIES(NOTINCLUDED)
Prior tothe useofanew unit, the rechargeablebattery shouldbe
charged according to the battery manufacturer ’sinstructions. Be-
fore using the battery charger,read allinstructionsand cautionary
markings on the battery and in this instruction manual.
After being stored for 60 days or more,the batteries may losetheir
charge. After long periodsof storage, batteries shouldbe charged
prior touse.
BATTERY CHARGING
(1)Plug the chargerinto any working 110 or 220/240v mains electri-
cal outlet.The use of any attachment not supplied withthe
charger may resultinthe risk of fire, electricshock,or injury to
persons.
(2)Followthe battery manufacturer’sinstructions for charging time.
(3)After the battery manufacturer’srecommended charging time
has been completed, unplug the charger and remove the battery.
(4)Batteries shouldalwaysbe stored in afullycharged state.
Toensure optimum batteryperformance, follow theseguidelines:
(a) Although overcharging the batteries for up to24 hourswill
notdamagethem,repeated overcharging maydecrease use-
fulbattery life.
(b) Alwaysstore batteries intheircharged condition. After a

2524
Chapter24: CONFORMITY TO SAFETY STANDARDS
The Comfy EMS devicesarein compliancewith the following standards:
EN 60601-1-2: 2007Medical electrical equipment -
Part1-2:General requirementsfor basic safetyand essential performance
-Collateral standard:Electromagnetic compatibility-Requirementsand tests
EN 60601-1:2006 Medical electricalequipment -
Part1: General requirements forbasic safety and essential performance
Chapter 25: WARRANTY
All Comfy EMS models carry awarranty of three years fromthe
dateof delivery.Thewarranty appliestothestimulatoronlyand
covers both partsand labor relating thereto.
The warranty does not applyto damage resulting fromfailure to
followthe operating instructions, accidents, abuse, alteration or dis-
assembly by unauthorized personnel.
Manufacturer: Everyway Medical Instruments Co., Ltd.
3F., No.5, Ln. 155, Sec. 3, BeishenRd.,
Shenkeng Dist., NewTaipei City 22203,
Taiwan. (R.O.C.)
Representative in theEU:
REHABEUROPASL
SANT GERVASI DECASSOLES, 963o4a
08022BARCELONA,SPAIN.
INFORMATION FOR DISTRIBUTOR:
Pleasecontact the above mentioned manufacturer for technical
supportand documentation when necessary.
Chapter 22: SAFETY-TECHNICAL CONTROLS
For safetyreasons,check your Comfy EMS eachweek based on
the following checklist.
1. Checkthe devicefor external damage.
-deformation of the housing.
-damaged or defective output sockets.
2. Checkthe device for defective operating elements.
-legibility of inscriptions and labels.
-make sure the inscriptionsand labels are not distorted.
3. CheckLCD
-Mode and all parameters must be visible on theLCD.
4. Checkthe usabilityof accessories.
-patient cable undamaged.
-electrodes undamaged.
Please consult your distributor if there are any problems EMSwith
deviceand accessories.
C h a p t e r 2 3 : M A L F U N C T I O N S
Should any malfunctions occur while using the Comfy EMS , check
- whether the controlsor parameters are setto the appropriate
formoftherapy.Adjust thecontrolcorrectly.
-whether the cableiscorrectlyconnected to the device.The
cables should be inserted completely into the sockets.
-whether the LCD revealsthe menu.If necessary,insert anew
battery.
- for possible damage to the cable. Change the cable if any dam-
age is detected.
*Ifthereis anyotherproblem, please returnthedeviceto your
distributor. Do not try torepairadefective device. Copyright ©2011 by Everyway Medical Instruments Co., Ltd.
Edition : V1.2
Printed in March, 2011

2726
(Appendix II) Waveform of EV-805 Digital EMS
1. Constant Mode
Load: 500 ohm
Pulse Rate: 150Hz
Pulse Width: 300µs
Scope A:
VERT:10.0V/DIV
HORIZ:100µs
OUTPUT:42.2Vpk-pk
PulseRate:148Hz
Scope B :
VERT:10.0V/DIV
HORIZ:100µs
OUTPUT:42.4950Vpk-pk
Pulse width:324µs
(Appendix I) Test Environment

2928
3. Alternate Mode
Load:500ohm
PulseRate:150Hz
Pulse Width:300µs
Contraction Time:12 Sec
Relation Time:12Sec
RampTime:6Sec
2. SynchronousMode
Load: 500 ohm
Pulse Rate: 150Hz
Pulse Width: 300µs
Contraction Time:12 Sec
Relation Time:12Sec
RampTime:6Sec