ProMed ProM-500 User manual

ProM-500 EMS
Electrical MuscleS t i m u l a t o r
INSTRUCTION MANUAL

INDEX
Chapter Contents Page
Index 1
1. Introduction 2
2. Cautions 3
3. Warnings 4
4. Contraindication 4
5. AdverseReactions 4
6. GeneralDescription 5
7. Construction 5
8. TechnicalSpecification 6
9. Replaceable Parts 7
10. Accessories 8
11. GraphicSymbols 8
12. Attachment of ElectrodeLeadWires 9
13. L e a dWireMaintenance 9
14. ElectrodeOptions 10
15. Electrode Placement 10
16. Tips For Skin Care 10
17. Application of Re-usableSelfAdhesiveElectrodes 11
18. Adjusting The Controls 12
19. BatteryInformation 15
20. Maintenance,Transportation and Storage of
EMS Device 17
21 .Safety-technical Controls 18
22. Malfunctions 18
23. Conformity to SafetyStandards 19
24. Warranty 19
Manufacturer 19
Representative intheEU19

ChaeterUJNTBQDUCIlQM
EXPLANATION OFEMS
ElectricalMuscleStimulation isan internationallyaccepted and proven
wayof treating muscular injuries. It works by sending electronic
pulses tothe muscle needing treatment;this causes the muscle to
exercise passively.
It isa productderivedfrom the squarewaveform,originally invented
by John Faraday in 1831. Through the squarewave pattern itis able
to work directly on muscle motor neurons. EMShaslow frequency
and this in conjunctionwith the squarewave pattern allows direct
work on muscle groupings. This is being widely used in hospitals
and sportsclinics forthe treatment of muscular injuries andforthe
re-education of paralyzed muscles, to prevent atrophy in affected
muscles and improvingmuscletone and blood circulation.
HOW EMS WORKS
1. Relaxation of musclespasms
2. Prevention or retardation of disuse atrophy
3. Increasinglocalblood circulation
4. Muscle re-education
5. Immediate post-surgicalstimulation of calf muscles to prevent
venous thrombosis
6. Maintaining or increasingrange of motion
TheEMS unitssend comfortable impulses through the skinthat
stimulate the nerves inthe treatmentarea.When the muscle
receivesthissignal it contracts asifthe brain has sent the signal
itself. Asthe signalstrength increases, the muscle flexes asin
physical exercise. Then when the pulseceases, the muscle
relaxes andthe cyclestartsover again,(Stimulation, Contraction
and Relaxation.) Poweredmusclestimulatorsshouldonly be used
undermedicalsupervision for adjunctivetherapy forthe treatment
of medical diseases and conditions.
Chapter 2 : CAUTIONS
1. Safety of powered muscle stimulators foruse during pregnancy
hasnot been established.
2. Caution should be used for patients withsuspected or diagnosed
heart problems.
3. Caution should be used for patientswithsuspected or diagnosed
epilepsy.
4. Caution should be used inthe presence ofthe following:
a. Whenthere isa tendency to hemorrhagefollowing acute
trauma or fracture;
b. Following recentsurgical procedureswhen muscle
contraction may disrupt the healing process;
c. Over the menstruating or pregnant uterus; and
d. Overareas ofthe skin whichlack normal sensation.
5. Some patients may experienceskinirritation or hypersensitivity
duetothe electrical stimulation or electricalconductivemedium.
The irritation can usually be reduced by using an alternate
conductive medium, or alternateelectrode placement.
6. Electrode placement and stimulation settingsshould be based on
the guidance ofthe prescribing practitioner.
7. Poweredmusclestimulatorsshould be kept outofthe reach of
children.
8. Powered musclestimulators should be usedonlywith the leads
and electrodes recommended forusebythe manufacturer.
9. Portable powered muscle stimulators should notbe usedwhile
driving, operating machinery, or during any activity in which
involuntary musclecontractions mayputthe user at unduerisk of
injury.

Chapter 3 iWABNJNGS
1. Cautionshould be used in applying EMSto patients suspected of
having heart disease. Further clinical data is needed to show
there areno adverse results.
2. Electricalstimulationsafety has not been establishedduring
pregnancy.
Do notuseEMS during pregnancy.
3. Donot placeelectrodes onthe front ofthe throat as spasm ofthe
Laryngeal and Pharyngeal muscle may occur. Donot stimulate
over the carotid nerve,particularly withpatientswithknownsinus
reflex sensitivity.
4. Careshould be taken so thatwhenoperatingpotentiallydangerous
machinery the stimulator controls arenot changed abruptly.
5. Cases of skinirritation atthe electrodesitehavebeen reported.
Stimulationshould be stopped and electrodesremoved until the
cause ofthe irritation canbe determined.
6. Electrodes should notbe placedover the eyes, inthe mouth, or
internally.
7. Keepthisdevice outofthe reach of children.
Chapter 4: CONTRAINDICATION
Powered muscle stimulators should notbe used on patientswith
cardiac demand pacemakers.
Chapter 5: ADVERSEREACTIONS
Skin irritation and burnsbeneath the electrodeshavebeenreported
with theuseof powered musclestimulators.
o
Chapter 6 : GENERALDESCRIPTION
The ProM-500 isa battery operated pulse generatorthat sends
electrical impulsesthroughelectrodes tothe body and reaches the
underlying nerves or muscle group. The device is provided with two
controllable output channels,each independent of each other. An
electrode pair canbe connected to each outputchannel.
The electronics ofthe ProM-500 createelectrical impulseswhose
Intensity,PulseWidth,Pulse Rate, Contraction,Relaxation and Ramp
maybe alteredwith the switches.Dialcontrols are veryeasy touse
andthe slidecoverpreventsaccidental changes inthe setting.
Chapter 7 : CONSTRUCTION
fQCAF
(2)].EAD CONNECTOR
(3)INTENSITY CONTROL
(ON/OFF SWITCH)
(4)LED
p)CONTRACTION(ON) CONTROL
(6)RELAXATION(OFF) CONTROL
(7)RAMP CONTROL
(8)RATE CONTROL
(9)MODE CONTROL
(IQ)FULSE WIDTH SELETOR SWITCH
(ll)BATTERY STRIP
(12)BATTERY COMPARTMENT

Chapter 8: TECHNICALSPEClFiCATiQN
The terhniral specification details of ProM-500 are as follows.
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MECHANISM
Channel
Pulse Amplitude
Voltage
Wave Form
Power supply
Size
Weight
PulseRate
PulseWidth
ContractionTime
Relaxation Time
Ramp Time
Mode
Constant
Synchronous
Alternate
Operating Condition
Remark
TPHHIHAI DFRCRIPTION
Dual, isolated between channels
Adjustable,0-80mA
Max output 80mA(peak to peak)into
SOOohm load eachchannel.
Adjustable, 0-40V
Max output 40V(peak to peak ) into
SOOohm loadeachchannel.
Asymmetrical Bi-Phasic SquarePulse
One9 Volt Battery,type6F22
95(H) x 65(W) x 23.5(T) mm
115 grams (battery included)
Adjustable, 2 Hz~150 Hz
Selectable, 100us, 200us, 300ns
Adjustable, 1-30 seconds
Adjustable, 1-45 seconds
Adjustable, 1-8 seconds
S(Synchronous), C(Constant), A(Alternate)
Constantstimulationbased on setting value.
Stimulation of both channelsoccurs
synchronously.
The stimulation oftheCH2 willoccur
after the1st contraction ofCH1is completed.
Temperature : 0°~40°C
Relative Humidity : 30%~75%
Atmosphere Pressure :
700Hpa~1060Hpa
There maybeuptoa +/-20% tolerance
of all parameters.
o
Chapter 9 : REPLACEABLEPARTS
The replaceable parts and accessories ofEMS devices areas given
below Except leads, electrodes and battery, batterycase cover,
please donottryto replace the other parts ofa device.
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PARTS
LEADWIRES
ELECTRODES
9V BATTERY,TYPE6F22
BELT CLIP
BATTERY CASECOVER
LEADCONNECTOR
MAINPCB
INTENSITYKNOB
CONTRACTIONKNOB
RELAXATIONKNOB
PULSEWIDTHKNOB
PULSE RATEKNOB
RAMP KNOB
MODE KNOB

ChapteMO: ACCESSORIES
Each set ProM-500 are completedwith standard accessories and
standard label as given below
I. Accessories
REF. NO. PRODUCT
1. ProM-010 40X40 MM AdhesiveElectrodes
2. KE-26ElectrodesLeads
3. GC-01 9V Battery,type6F22
4. InstructionManual
5. CarryingCase
II. LABEL
QTY
4 pieces
2 pieces
1 piece
1 piece
1 piece
MODEL :
Serial No.
SUCPLV VOtI*OE
HlMM^'to,"
3roM-500 """ ""•*•
lAffl
.'.vl-:'!^,,..-..'":.'. :,!.',.?. ' JnlVl v. '"•»•
^1 T h e labelattached tothe back of device
contains importantmessageabout this
device- model, serial number, supply
voltage, the name of manufacturer and classification.Please donot
remove.
Chapter 11: GRAPHICSYMBOLS
1. /j\e Operating Instructions
2. •*• Degree of Electrical Protection BF
3. ^W^ Donot insert the pluginto AC power supply socket
4. DirectCurrent (DC powersource)
Chapter 12: ATTACHMENT OF ELECTRODELEAD
WIRES
The wires providedwith the system insertinto the jack sockets
located ontopofthe device. Holding the insulated portion ofthe
connector,push the plug endofthe wireinto oneofthe jacks(see
drawing); oneortwo sets of wires maybe used.
V^-^J LEADWBi
After connecting the wires tothe stimulator, attacheachwire toan
electrode. Use carewhen you plug and unplug the wires. Jerking
the wireinstead of holding the insulated
connector body may cause wire breakage.
CAUTION
Do not insert the plug ofthe patientleadwireinto theAC power
supply socket.
Chapter 13 : LEADWIREMAINTENANCE
Clean the wires by wipingwith a damp cloth. Coatingthem lightly
withtalcum powder will reducetangling and prolong life.
O

Chapter 14: ELECTRODE OPTIONS
You should usethe samesize and type of electrodesthat was
suppliedwithyour EMS device,unlessyour clinician instructs you to
usea differentelectrode.Follow application procedures outlined in
electrodepacking, to maintain stimulation and preventskinirritation.
Usethe legallymarketed EMS electrode is recommended. The device
is completedwithstandard carbonfilmadhesiveelectrodes in size
4x4cm.
Chapter 15: ELECTRODE PLACEMENT
The placement of electrodes canbeoneofthe most important
parameters in achievingsuccesswith EMS therapy. Of utmost
importance isthe willingness ofthe clinician totrythe variousstyles
of electrodeplacement to find which method best fits the needs of
the individualpatient.
Every patient responds to electricalstimulationdifferently and their
needs may varyfrom the conventional settingssuggested here. If
the initial results arenot positive,feelfree to experiment.Once an
acceptable placement has beenachieved,markdown the electrodes
sites and the settings on the patient'sReferencesheet of this manual,
so the patient can easilycontinuetreatment at home.
Chapter 16 : TIPS FOR SKIN CARE
To avoidskinirritation, especially ifyou have sensitiveskin,follow
these suggestions:
1. Wash the area of skinwhere you will be placing the electrodes,
usingmild
soap and waterbeforeapplying electrodes, and aftertakingthem
off. Be sure to rinsesoap off thoroughly anddry skin well.
2. Excess hair maybe clippedwithscissors; donot shavestimulation
area.
3. Wipe the areawith the skinpreparationyourclinician has
recommended. Let thisdry. Applyelectrodes as directed.
4. Manyskinproblems arisefrom the "pullingstress"fromadhesive
patchesthat are excessivelystretchedacross the skin during
application. To preventthis,applyelectrodesfromcentreoutward;
avoid stretchingover the skin.
5. To minimize "pulling stress", tape extra lengths of lead wires to
the skin ina loop to preventtugging on electrodes.
6. Whenremovingelectrodes,alwaysremove by pulling inthe
direction of hair growth.
7. Itmaybe helpful torub skinlotion on electrodeplacementarea
when not wearing electrodes.
8. Neverapplyelectrodesoverirritated or brokenskin.
Chapter 17 : APPLICATION OF RE-USABLE SELF
ADHESIVE ELECTRODES
Application
1. Clean anddrythe skin atthe prescribedareathoroughlywith
soap and waterprior to application of electrodes.
2. Insert the lead wire into thepin connector onthe pre-wired
electrodes.
3. Remove the electrodesfrom the protectiveliner and apply the
electrodes firmly tothe treatmentsite.
Removal
1. Lift atthe edge of electrodes and peel; donot pull onthe lead
wires because itmay damage the electrodes.
2. Place the electrodes onthe liner and remove the leadwire by
twisting and pulling atthe sametime.

1. Donot apply to brokenskin.
2. The electrodes should be discardedwhenthey are no longer
adhering.
3. The electrodes are intended for single patient use only.
4. If irritationoccurs, discontinue use and consultyourclinician.
5. Read the instruction foruseof self-adhesiveelectrodes before
application.
Chapter 18 : A D JUS T I NG THE CONTROLS
1. SlideCover:
A slide-on panelcovers the controls for
Contraction Time,RelaxationTime ,RampTime,
Pulse Width, and Pulse Rate. Your medical
professional may wish toset these controls
for youand requestthat you leave the cover
in place.
2. Display Led
Each ofthe leds illuminates whenever the electronics ofthe device
create a currentimpulse at contraction time and does not illuminate
when the stimulation is ceased at relaxationtime. Duetothe capacity
of the human eye, the illumination ofthe lamp can only be
recognized uptoa frequency of approximately 30Hz.At higher
frequencies, the lampwillappear tobe constantly illuminated.
3. On/OffSwitch and Intensity Controls:
If bothcontrols are in the off-position(whitemarkings on the
housing), the device is switched o f f .
By turning the controlsclockwise, the appropriate channel is
switched onandthe impulsedisplay led will illuminate and begin
to pulse according tothe frequency s e t .
The currentstrength ofthe impulsestransmitted tothe electrodes
increasesfurtherwhen the control is turned clockwise.
To reduce the currentstrength or switch the deviceoff,turn the
control counterclockwise tothe requiredsetting or off-position,
respectively.
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4. Lead Connector
Connection ofthe electrodes is madewith two-leadconnector.
The devicemust be switched off beforeconnecting the cables.
Both intensitycontrols must beattheOff position. Electrodes
must be pressedfirmly onthe skin.
5. Pulse Rate Control:
Thisdialdetermines how manyelectricalimpulses are applied
through the skineach second. By turning thesecontrols, the
number of currentimpulses per second (Hz) f o r both channels
can be continually adjusted.Unlessotherwiseinstructed,turn
the pulse rate control to the 70-120 Hz range.
6. PulseWidthControl:
Thisdialadjusts the length of time.Eachelectricalsignal is applied
through the skin, whichcontrols the strength and sensation of

the stimulation.There are3 PulseWidths of options 100, 200and
300us, Push the dialuntil the desiredposition is reached.
7. Contraction(On)TimeControl
The contractiontime control adjusts the time of stimulation. By
turning this control, the contraction time canbe pre-set. The
range is adjustablefrom 1 second to30 seconds. The contraction
time ofEMS device canbe adjusted by turningthisdial.
Relaxation(Off) Time Control
This dialdetermines the time of relaxation. The stimulationceases
at settingrelaxationtime and thenre-start ina cycle pattern. The
relaxationtime of both channels is changed by turningthis dial.
The range ofitis adjustablefrom 1 second to45 seconds.
9. RampTimeControl
Thisdialcontrols the time intensity of currentoutputthatincreases
from 0 to the settinglevel.When the ramptime is set,each
contraction maybe ramped in orderthatsignalscome on gradually
and smoothly. The ramp time is adjustable from 1to8 seconds by
turningthis switch.
t ]
L'..V i
10. Mode Control
Thisdial controls the outputmode ofthe unit.There are three
mode of options, S(Synchronous), C(Constant) and A(Alternate).
Push the dial to select a mode which is needed.
r
11. Check/Replace the Battery:
Overtime, in order to ensure the functional
safety of EMS, changing the battery is
necessary.
1. Makesurethatbothintensity controls are
switched tooff position.
2. Slide the battery compartment cover and
remove.
3. Remove the batteryfrom the compartment.
4. Insert the batteryinto the compartment.
Note the polarityindicated onthe battery andthe comartment.
5. Replace the battery compartment cover and slide to close.
Chapter 19: BATTERY INFORMATION
PRECATIONS
1. Remove battery if equipment isnot likely tobe used for some time.
2. Please recycle the usedbattery in accordancewith domestic
regulation.

3. Do not throw the used batteryinto fire.
If youuse rechargeable batteries, pleasefollow the instructions.
RECHARGEABLE BATTERIES:
Prior totheuseofa new unit, the rechargeable battery should be
charged according tothe battery manufacturer's instructions. Be-
fore using the batterycharger,read all instructions and cautionary
markings onthe battery andin thisinstruction manual.
After beingstored for60 days or more, the batteries may losetheir
charge. After longperiods of storage,batteries should be charged
prior to use.
BATTERY CHARGING
(1) Plug the charger into any working 110 or 220/240vmainselectrical
outlet. Theuseofany attachment not suppliedwith the charger
may result inthe risk of fire, electric shock, or injury to persons.
(2) Follow the batterymanufacturer'sinstructions for charging time.
(3) After the battery manufacturer's recommended charging time has
beencompleted,unplug the charger and remove the battery.
(4) Batteriesshould always be stored ina fullychargedstate.
To ensureoptimum batteryperformance,followthese guidelines:
(a) Althoughovercharging the batteries forupto24 hourswill not
damage them,repeated overcharging may decreaseuseful
battery life.
(b)Always storebatteries in theircharged condition. After a
battery has beendischarged, recharge itas soon as possible.
If the battery is storedmore than 60 days, itmay need tobe
recharged,
(c) Donot short the terminals ofthe battery.Thiswillcause the
battery togethotandcan causepermanentdamage. Avoid
storing the batteries in your pocket or purse where the terminals
may accidentallycomeintocontactwithcoins,keys orany
metalobjects.
(d) WARNINGS:
1. Donot attempt to charge any othertypes of batteries in your
charger,other than the nickel-cadmium rechargeable
batteries. Othertypes of batteries may leak or burst.
2. Donot incinerate the rechargeablebattery asitmay explode!
Chapter 20: MAINTENANCE. TRANSPORTATION
AND STORAGE OFEMS DEVICE
1. Non-flammablecleaningsolution is suitable for cleaning the device.
Note: Donot smoke or workwithopenlights(forexample,candles,
etc.)
whenworkingwith flammable liquids.
2. Stains and spots canbe removedwith a cleaning agent.
3. Donot submerge the device in liquids or expose itto largeamounts
of water.
4. Return the device tothe carrying box withspongefoam to ensure
that the unit is well-protectedbeforetransportation.
5. Ifthe device isnottobe used fora longperiod of time,remove the
batteries from the batterycompartment(acid may leakfromused
batteries and damage the device). Putthe device and accessories
in carrying boxand keep itin cool dry place.
6. The packed EMS devicecould be stored and transportedunder
the temperaturerange of -20°C - +60°C,relativehumidity 20% -
95% Aatmospherepressure 500hPa~1060hPa.

Chapter 21: S A F E T Y - T E C H N I C A L CONTROLS
For safetyreasons,checkyour ProM-500eachweekbased onthe
following checklist.
1. Check the device for external damage,
-deformation ofthe housing.
- damaged or defectiveoutput sockets.
2. Check the device for defectiveoperating elements.
- legibility of inscriptions and labels.
- makesure the inscriptions and labels arenot distorted.
3. Check Led
- led must be illuminated whenswitched on.
4. Check the usability of accessories.
- patientcable undamaged.
- electrodesundamaged.
Pleaseconsultyourdistributor if there areany problemswith device
and accessories.
Chapter 22: MALFUNCTIONS
Should any malfunctionsoccurwhile using the EMS, check
- whether the switch/control issettothe appropriateform of therapy.
Adjust the controlcorrectly.
- whetherthecableiscorrectlyconnectedtothedevice.Thecables
should be inserted completelyinto the sockets.
- whether the impulse display ledis illuminated. If necessary, insert
anew battery.
- for possibledamage tothe cable.Change the cable ifany damage
is detected.
- If there is any other problem,please return the device to your
distributor. Donottryto repair a defectivedevice.
Chapter 23: CONFORMITY TO SAFETY
STANDARDS
CONFORMITY TO MOD REQUIREMENTS
The ProM-500 EMS devices arein compliancewith theEN 60601-1-
2:1993 andEN 60601-1:1990+A1:1993+A2:1995+A13:1996 safety
standards.
Chapter 24: WARRANTY
All ProM-500 models carry a warranty ofone yearfrom the date of
delivery. The warrantyapplies tothe stimulatoronly and coversboth
parts and labour relatingthereto.
The warrantydoes not apply to damage resultingfrom failure to
follow the operating instructions, accidents, abuse, alteration or
disassembly by unauthorized personnel.