ProMed ProM-660 User manual

ULTRASOUND THERAPY DEVICE
PersonalBeauty / Diathermy / HealthCareProduct
MODEL NO:ProM-660
USER MANUAL
BEFOREUSING THE DEVICE, PLEASE READ OPERATING INSTRUCTION CAREFULLY.
INTENDED FOR USE
The ProM-660generatesdeepheatwithinbodytissues for the treatment of
selectedmedicalconditionssuch as relief of pain, musclespasms, and joint
contractures, butnotforthe treatment of malignancies.
CONTRAINDICATIONS
1. Donotuse over or nearbonegrowthcentersuntilbonegrowth is complete.
2.Donotuse over a healingfracture.
3. Donotuse over the eyes.
4.Donotusefor patientswithimplantedneurostimulationsystemsbecausetissue
damage can occur atthe location ofthe implantedelectrodesresulting in severe
injury or death.This can alsodamage the systemcomponents.
5.Donotuseto treatmalignancies norinthe regionwithmalignanttumors.
6.Donotusefor patientswithdemandtypecardiacpacemakers.
7.Donotuseon someone whois pregnant.
8.Donotuse overischemictissues in patientswithvasculardiseasewhere the
bloodsupplywould be unable to follow the increase in metabolic demand and
tissuenecrosismightresult.
9. Donotuse over the carotidsinusnerves or arteries,laryngeal or pharyngeaf
muscles.
PRECAUTIONS
1. Donotuseon patientswithhemorrhagicdiatheses.
2. Donotuse over an area ofthe spinalcordfollowing a laminectomy, i.e.,when
majorcoveringtissueshavebeenremoved.
3.Donotuse overanestheticareas.
4. Avoid bony prominences.
5. Whenusingultrasound,keep the soundheadmovingwhilemaintainingcontact
withskin.
6. If treatmentbecomesuncomfortable,inform or contactyourphysician.
7.Donot immerse the Ultrasounddevice in water or othersolvent.
8.Donotuse overmetallicimplants,especiallyprostheses with a cement-matrix.
EXPLANATION OF ULTRASOUND STIMULATOR EFFECT
Ultrasoundequipmentgenerates high frequencysoundwaves (1 MHz) that are
transferred toa specificbodyarea viaa round-headedprobe. The soundwaves
traveldeepintotissue and create gentleheat. Asthe probeglides over the skin's
surface, soundwavespenetrate the skin'ssurfacecausingsofttissues to creating
deep heat. In turn, the heatinducesvasodilatation:drawingbloodinto the target
tissues. The generateddeepheat is found to helprelievepain and reducemuscle
spasms.

SPECIAL FEATURES
1. The precise parts are assembled and testedunderstrictprocess.
2. Designedwithsinglechipmicro-processor, the quality is assured.
3. Precious alloy round-headedprobecreatessmooth,nice-touchingsurface to
theskin.
4. Attractiveexteriorfits tothe humanbody and easy to hold and convenient touse
5. Micro-computer single button,veryuser friendly.
6. On/Offbuttonalsofunctions toset outputintensity.
7. Threeoutputintensityselections to meetdifferentrequirements.
CAUTIONS
A Always use this device under the directions of professional physician.
A Patients with following diseases or symptoms should notusethe device.
• Pregnancy or Mensesperiod.
• Acutedisease,Heartdisease,Tubercledisease,Facialneuralgia,
Pernicioustumor,Hemophilia, High fever,abnormalbloodpressurepatient,
or underabnormallyhealthyconditions.
• PatientswithSensitivephysicalcondition,Ringworm,Dermatitis,Infectious
disease.
• Person who can'texpressthemselvesclearlysuch as infants, mental
disables,afteralcoholicdrinking or under extreme fatigues.
• Don't applythisproduct on followingspots:Gash,Mucousmembrane in
the mouth,neuralgiaspot,surgeryarea,skinwith sun burnproblem,
sensitive skinirritated by cosmetic,skinimplantedwithmetal,plastic and
silicone material.
•Donotuse withotherelectronicequipmentssuch as EGG machine...etc.,
eventhisdeviceconforming totheEMC requirements.
ADONOTuseonthe thoracicregion ifyouarea pacemakeruser.
ADONOTuseonthe regionwith malignant tumors.
ADONOTuseonthe region of blood-lackingtissue,becausethere isnot enough
bloodsupplied to meet the metabolicdemand, so that the tissueswouldresult
in necrosis.
AForthe patientwithbleedingphysique, DONOTuse ProM-660.
ADONOTuseonthe anesthesiaregions.
'* Warning*
The devicecompliescompletelywith all parts of 21CFR1050.10 of the
performancestandard for sonic,infrasonic and ultrasonicradiation-emitting
product.
Cautions- useof controls or adjustments or performance of proceduresother
thanthosespecifiedherein may result in hazardousexposure to ultrasonic
energy.
PARTS OF THE DEVICE
LED INTENSITY
ALLOY PROBE
SPEC.LABLE
DC RECEPTACLE
STEPS TO CONNECT THE ADAPTOR
1. Insert theDC plug oftheadaptor
into theDC receptacle onthe main
unit.( asthe picture )
2. Pleasehold the main unit tightly ,
wheninsert theDC pluginto the
DC. Insertand pull outtheDC
plug in correctdirection.
3. There are manydifferentadaptors
(specification & shape ofthe plug)
used by differentcountries.
4. Insert the adaptorinto the power
supply socket, (asthe picture)
Be sure the powervoltage is
appropriate.
— ATTENTION —
Please usethe original adaptor. The user cannot re-assemble or
change the specification ofthe adaptor. Personal injury or damage
to the unit maybe caused ifyoudonot follow the above instructions.

FUNCTION TEST OF ULTRASOUND ACTION
Intensity LOW:The waterdropsvibrateslightly.
MED : The waterdropsvibratestronger, and withatomization.
HI :The waterdropsvibratevery strongly, and withatomization
phenomenon.
TROUBLESHOOTING
The device is manufacturedthroughcompletequalityassurancesystem. If there
is any performanceproblem,pleasecheck the chartbelow for problems youcan
fix. Performanceproblemsoftenresultfromlittlethingsthat youcan find andfix
at homewithouttools. This can save youthe cost ofa service call.
PROBLEM
LEDdoes notlighton.
LED is performingnormally,
but no outputfunctionoccurs
CHECKPOINTS
• The plug of adaptor isnot
insertedinto the socket
properly.
•TheDC plug of the adaptor
is not insertedinto theDC
receptacle onthe device
correctly.
•Didnot press ontheON/
OFF button.
• Outputintensitybutton
setting is incorrect.
POSSIBLE SOLUTION
• Insert the plug of the
adaptorinto the socket
again.
• Connect the adaptorwith
the deviceagaincorrectly.
• Press the ON/OFFbutton
again.
• Pleasemakesure and set
it again.
For technical documentation or support,pleasecontactyourlocal
distributor or the manufacturer as shown onthe label.
HOW TOUSETHE DEVICE
Connect the adaptorwith the main unit.
Plug the adaptorinto DC powersupplysocket.
Applyappropriateamount of getonthe probe andonthe treated area.
Press On/Offbutton to turn onthe power, theLED will light upin green.
To adjust the outputintensity,pushOn/Offbuttonslightly.
When theLEDisin greencolor, the vibrating isinLow lever;pressOn/Offbutton
again, theLED will turn to orangecolor, the vibrating isin Mediumlever;press
On/Offbuttononce again, theLED will turn tored color, the vibratingbecome in
High level.
To returnoutput tolow level,justpressOn/Offbutton one moretime.
Ifyou need to turn the power off prior tothe autotimershutdown:Press the On/
Off button and hold it down for just over 3 seconds, the device will then turn off.
Usinggentleupward or circularmotionswith the probe on treatedarea.
Keep the probegliding over the skin, DO NOT stop the motion atthe sameplace
too long.
CAUTION —
!\ONOT hold the motion atthesame place too long.
MAINTENANCE
Don't put intowater,neither fall down or throw to groundfromheight.
Donotuse volatile solutionsuch as turpentine orgasolinetorubthedevice.
Please clean the devicehousing & afloy probe bywet towel or tissue.
Do not use coarse or usedfabric torubthe surface ofthe alloyprobe.
Store at room temperature ina dry place.

Prescription Statement
PRODUCT POST SALES QUESTIONNAIRE
Caution: Federal law restricts this device to sale byoronthe order ofa practitioner
licensed bythelawofthe State in whichhe/shepractices,according to
21 CFR801.109.
UNIT SPECIFICATION
1. Power: Switchadaptor
Input: AC100-240V, 50/60HZ
Output: DC 24V
2. Frequency: 1 MHz ±10%
3. Type: Non focusing
4. Pulse width: 2ms ±10%
5. Repetition rate: 150 Hz± 10%
6. Waveform;Pulse
7. Temporal maximum power: 4W± 10%
8. Temporal maximum effective intensity: 1,57W/cm2 ±10%
9. Effectivemaximumtemporal intensity/
Effective average effective intensity: 1.571 0.47=3.34 ±10%
10. ERA: 6.16 square centimeter ± 5%
11. BNR: Max.5.6:1
12. Auto-time setting: 30 minutes ±10%
13. Outputintensity:Low,Medium,High
14. Size of main unit: 172(L)x 54(W)x42(H) mm
15. Weight of main unit: 120 grams
ProductModel: PrpM-660 product Series NO.: —
Customer'sName:
Purchasing Place: Date'
1. Does there exit any unclear printing, words not easy to understand, or
other confusion inthe operation instruction?
No D
Yes .
2. Is there any damaged parts to threatenpersonal safety?
DNO D
Yes .
3. Is there any important message tobe omitted?
CDNo HH Yes
4. Doestherehave any improper action that different from the instruction
manual?
STORAGE CONDITIONS
Operating Conditions:
Conditions for Storage/Transportation:
10t-40°C, 40%~90%r.H.
-100O60aC, 30%~95%r.H.
X
5.1s there any problem about this product that can't be solved by local
distributor?
QNO D Yes .
Please send the completedquestionnaire tothe followingaddress:
1800 Byberry Road, unit 905, Huntingdon Valley, PA. 19006
TEL:[phone]
Ordropyoursuggestioninto our E-mail:[email protected]m