user manual pers comp family eng v4

7/29/2019 User Manual Pers Comp Family ENG V4

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INSTRUCTION MANUAL

the original PST Personal Compact family

for


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2

TABLE OF CONTENTS

PRESENTATION ..............................................................................3

PST INDICATIONS ......................................................................... 4

PST CONTRAINDICATIONS .......................................................... 5

SIDE EFFECTS - MEDICATION ...................................................... 5

TECHNICAL WARNINGS ................................................................ 6

PST TREATMENT PROCESS ........................................................ 7

SET UP FOR TREATMENT ............................................................. 7

USER STEPS ................................................................................... 8

TROUBLESHOOTING ................................................................... 12

CHANGE OF FUSES ..................................................................... 13

TECHNICAL DATA ......................................................................... 14

WARRANTY - AFTER-SALES SERVICE .......................................15

APPENDIX TABLES 1 ~ 4 ......................................................16 ~ 19

This medical device was introduced to the market in accordance with

Medical Device Directive 93/42/EEC as well as the amendment 2007/47/EC.21.00.10 User Manual PST Personal Compact family EN 21/03/2010 V4 approved


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3

PST Personal

Compact

PST DVD

Instruction Manual

Chipcard(in plastic case)

Power cable (inside the glove)

PRESENTATION

Thank you for choosing the PST Personal Compact family. PST

(Pulsed Signal Therapy) treatment devices have been developed

based on decades of scientific research and are now manufacturedin accordance with the highest quality standards that apply to the

medical industry.

Please read this instruction manual carefully before operating your

PST device to ensure proper usage and optimal results.

The case contains the following items:

Fuses(in plastic case)

PST Applicator(inside the glove)


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4

PST INDICATIONS

The PST Personal Compact was developed for the treatment of muscu-

loskeletal disorders, particularly osteoarthritis (arthrosis), including degen-

erative joint diseases, and posttraumatic or postoperative disorders in joint-

related structures. PST uses patented signals that emulate those innate in

the body and can effectively support and accelerate the bodys own natural

healing processes. A standard course of treatment entails 9 sessions, of 60

minutes each carried out on consecutive working days. If need be, one-day

pause after the 6th treatment hour is permitted. A 12 session course is only

appropriate when the

Lower back is being treated, or

Patient feels that additional benefit can be derived from supple-

mentary 3 sessions

Treatment must not be interrupted for longer than 2 days (48 hours). If

longer than 48 hours repeat course of 9-12 sessions.

Potential joint areas for treatment are highlighted in red in the following

diagram (only one joint shaded for simplicity in the case of symmetrical

joints):

NeckShoulder

Hand

Knee

Elbow

Ankle

Foot

WristHip

Lower

Back

The patented PST technology is not only effective in pain management but

also an alternative medical therapy which is non-invasive, painless and free

from known harmful side effects.


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5

PST CONTRAINDICATIONS

In general, patients with pacemakers, tumours and/or bacterial infections,

metal implants, epilepsy, angina pectoris, heart failure, arrythmias, heavy

bleeding, as well as pregnant women and children under the age of 10,

should seek advice from their PST or GPM (Groupe President Medical)

doctor, as certain parts of the body may be treated, despite the presence of

these diseases.

Treatments contraindicated during the 9 or 12 day of PST treatment, and

6 weeks thereafter, include :

intraarticular injections

invasive treatments passive manipulation of the joint (chirotherapy, osteopathy,

physiotherapeutic measures, including sling table treatment and

massage).

SIDE EFFECTS - MEDICATION

You may experience a slight tickling sensation or warmth during the treatment.

Changes or intensification in pain symptoms may also occur in the initial

phase of treatment. However, do not be concerned, as this is only temporary

and considered as a positive prognostic response to the treatment.

In general, if you are taking any medication avoid making any changes

during the treatment period, we recommend targeted exercises to tone up

the appropriate muscles in the treated area after the treatmentas prescribedby you physiotherapist, additionally to optimize the success of PST.


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6

TECHNICAL WARNINGS

Ensure that this instruction manual is always returned to its compartment! Please

observe and adhere to all warnings and instructions provided on the device andits instruction manual.

Visual inspection prior use:

Casing of the PST Personal Compact is not damaged in any way

Power cord and power plug are in good working order and not damaged

Please ensure that the safety stickers are in place

Power Cable:

Never attempt to replace the power cable yourself as it is a specially manufactured

cable. Do not continue to use the device if the power cable is damaged. Do not

clamp nor bend it.

Device usage:

The device must not be close to any hot parts or appliances (e.g., heating,lamps)

Do not put any containers with liquids on the device (e.g., drinking cups, vases)

The device should be used only in dry interior spaces. Do not use it in damp

locations (e.g., bathrooms, saunas)

Do not cover and do not insert the device in enclosed space (e.g., in a shelf)

Do not employ it under direct sunshine

Do not use simultaneously with diathermic appartus or microwaves. Observe

minimum distance according to table 4 page 19

Always switch off your device after each session

Cleaning:

Switch off the device and unplug the power cable before cleaning

Clean the applicator with a soft, slightly damp cloth

Never use petroleum-based cleaners or solvents

Storage:

When not in use, please store your PST Personal Compact device and manual

in the carrying case for safety


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7

DO NOT REMOVE THE APPLICATOR FROM THEJOINT DURING THE SESSION

DO NOT INTERRUPT THE TREATMENT

FOR MORE THAN 48 HOURS

PST TREATMENT PROCESS

Treat only one joint at a time (9 or 12 sessions see page 4)

1 treatment = 9 or 12 sessions

1 session = 1 hour 1 session per day on consecutive days

1 day off allowed after the 6th session only if needed

If you miss more than 2 sessions, start over again

After completion of 9 or 12 sessions, wait at least 2 months before retreating that

area

SET UP FOR TREATMENT

1 - Find the most comfortable position before starting a session

(quiet and relaxed)

2 - Remove all metallic objects: jewels, coins, watch, belt...

3 - The applicator is approved to touch human skin. A towel should be used

as shown in several of the following usage pictures in order to ensure

that the main body of the applicator is directly over the area to be treated

4 - Do not use the applicator on open wounds. Use a towel if needed toprotect the applicator

5 - Complete 9 or 12 treatments to the most painful joint and then proceed

to the next joint


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8

a) Applicator jack

b) Push tight

For removal

press red button

fi rmly

c) Power cable, note position

d) Connect to the mains or wall power source

USER STEPS

1 - Plug in


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9

FOR EACH SESSION

Treat only one joint at a time (9 or 12 sessions see page 4)

Always position and orient the applicator in the same way for the

complete treatment course of a single joint

Place the applicator so that the PST logo is visible, i.e. the opposite

side that touches the joint area is labeled accordingly

Stabilize the position of the applicator with a thin towel

Shoulder Elbow

HandWrist

2 - Posit ion the applicator


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10

Neck

Ankle Foot

Knee

No stretched leg No bended leg

Lower BackHip


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Number ofminutes left

Active light start:

session OK

Number of

sessions left

Beep signal: remove applicator from the joint

4 - Put the chipcard face up in the slot, insert fi rmly to end position

5 - Press START button

6 - End of session

7 - Switch OFF: power O posit ion*

LED lights up

Please ensure that you

are ready to start. Once

you push the start button,

one unit will be debited

from chipcard

0 = OFFDISCONNECT FROM

POWER SUPPLY

I = ONCONNECT TO

POWER SUPPLY

3 - Switch ON: power I posit ion


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12

TROUBLESHOOTING

DESCRIPTION ILLUSTRATION ACTION

The green light doesnot light up

The START button

does not function

properly

Ensure that the power

cable is fitted correctly.Check the fuses

E1 appears in the

LED screen

Put the card in the

slot in the prescribed

position

E2 appears in the

LED screen, your card

is empty

Your sessions of treat-ment are complete.

If you need another

therapy, insert a new

card

EE appears in the

LED screen,

Applicator malfunction

Contact the

After-Sales Service

The internal safety

shutdown has been

triggered.Switch the

device OFF for approx.

10 minutes and thenON again

E9 appears in the

LED screen

Unit must be serviced

by GPM (Groupe Pre-

sident Medical) tech-

nician

If you detect a fault that persists do not continue using the device!


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1. Switch off the PST controller

3. Unplug applicator jack and power cable

4. Open the fuse lid

(you may use a

screwdriver or a

pen)

2 Disconnect from the

mains or wall power

source

5. Remove the fuse

holder

6. Take the old fuses out and throw them away

7. Take 2 new fuses from the plastic bag attached

to the user manual

Fuse T 1.25A

(250 V) / 5x20mm

8. Carefully put the new fuses in the holder (both

fuses have to be parallel but the orientationdoesnt matter)

9. Put the fuse holder back in the device

a) Put the holder in place

10. The holder must

be aligned with the

surface area

11. Plug in the applicator jack and the power cable

12. Connect power cable to the

mains or wall power source

13. Switch the compact

on LED light up

If not please repeat steps 1-13. If no pos it ive

result call the GPM after sales-service.

CHANGE OF FUSES

Please observe the following steps when you change the fuses

b) Press the lid down


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14

TECHNICAL DATA

The PST Personal Compact is a class IIa medical device. It complies with

Medical Device Directive 93/42/EEC Appendix I, II-3 and IX rule 9, as well

as with the amendment to the Directive - 2007/47/EC.

Groupe President Medical is responsible for the proper ultimate disposal of

the device. Please return the device for disposal to GPM, headquartered in

Balaruc, France.

In addition our device complies with the norms the norms EN 60601-1:2006(German edition IEC 60601-1/A2:1995) and EN 60601-1-2:2006 (German

edition IEC 60601-1-2:2004).

General: Size and Weight

PST

Personal Compact

device

(W) 220 mm (D)180 mm (H) 75 mm

- weight 0,900 kg

Power: 50/60 Hz - 100/240 V AC

I max: 1,25A - Fuse T 1,25A

Output

Environmental conditions:

Atmospheric pressionTemperature

Atmospheric humidity

500 hPa ~ 1060 hPa+5 ~ +40C

35% ~ 80% not condensed

Storage and transport conditions:

Atmospheric pression

Temperature

Atmospheric humidity

Umax : 24 V PP

500 hPa ~ 1060 hPa

-10C ~ +50C

10% ~ 90% not condensed

0123

Symbol for Grounding/

Grounding equipment

conductor connection

Please observe and

adhere to all instructions

and warnings in this

manual and on the device

Do not throw

in the garbage.

Return to

manufacturer for

disposal

Declaration of conformity

with European market

standards

Device with type B

application part


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15

WARRANTY - AFTER-SALES SERVICE

The PST Personal Compact product line is covered by a standard limitedGroupe President Medical (GPM) 2-year standard limited-warranty from thepurchase date.

The warranty covers all the material defects and manufacturing faults associatedwith the product. Only customers who bought their product from GPM or from aGPM authorized seller are covered under this warranty.

The standard limited warranty does not cover the damages due to improper use;negligence; electrostatic shocks; incorrect installation; commercial use; productswith removed, damaged or modified labels and safety stickers; malfunctionscaused by other devices or improper use that does not comply with instructionsprovided in the user manual.

In order to apply the warranty, please contact the GPM after-sales service eitherper e-mail [email protected] or over the phone on +33(0)4 67 46 36 96. You will be asked for your name, address, phone number,e-mail address as well as the serial number of the concerned product. Once itis confirmed the unit is still inside the 2-year warranty period, you will be givena case number for reference. You have to include this number with your productwhen you return it to GPM. The product is to be sent back to GPM packagedappropriately in the original packaging (or any other packaging which guaranteesequivalent protection); the product is to be sent to the address communicated

when you get your case number.

Once the GPM technical team receives the returned product they will inspect todetermine the root cause of the problem, and

If they determine the problem is due to material defects and/or manufacturingfaults the product will be repaired or replaced and shipped back to you at nocost

If they determine the problem is due to conditions not included in the limitedwarranty, they will estimate repair charges and contact you via email or phone

to get your approval for the repairs/replacements. If you authorize the repairyou will be invoiced and the repaired unit will be shipped back to you on receiptof payment by GPM or an authorized agent.

During the initial contact with the after-sales service if it is determined that thestandard warranty period has expired, you still have the option of sending the unitback for inspection and repair. In this case you will be provided a cost estimatefor repairs once the unit is received and inspected by the GPM technical team.

Any repairs under this scenario will only be processed after your approval of thecost estimate and receipt of payment.

For professional use: the PST Personal Compact device should be inspectedby an approved Groupe President Medical service center 2-years after purchaseand every 2-years thereafter. See our Website for locations of Service Centers.


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Table1Guidanceandmanufacturer

sdeclarationelectromagneticemissions

for

allEQUIPMENTAND

SYSTEMS(see5.2.2.2inEN

60601-1-2:2004)

G

uidanceandmanufacturersdeclarationelectromagn

eticemissions

ThePSTP

erson

alCompactf

amilyisintend

edforuseintheelectromagneticenvironmentspecifiedbelow.

ThecustomerortheuserofthePSTP

ersonalCompactfamilyshouldassurethatitisusedinsuchanenvironment.

Emissionstest

Compliance

Electromagneticenvironment-guida

nce

RFemissions

CISPR11

Group1

ThePSTP

ersonalCom

pactf

amilyusesRFenergy

onlyforitsinternal

function.Therefor,itsR

Femissionsareverylowand

arenotlikelyto

causeanyinterferenceinnearbyelectronicequipment.

RFemissions

CISPR11

ClassB

ThePSTP

ersona

lCompactf

amily,issuitable

foruseinall

establishments,includingdomesticestablishmentsa

ndthosedirectly

connectedtothepubliclow-voltagepowersupplynetworkthatsupplies

building

susedfordomesticpurposes

.

H

armonicemissions

IEC61000-3-2

ClassA

Voltagefluctuations/

flickeremissions

IEC61000-3-3

Complies

1 2 3 4 6 7 8


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17

Table2

Guidanceandmanufacturersdeclarationelectromag

neticimmunity

for

allEQUIPMENTandSYSTE

MS(see5.2.2.2inEN

60601

-1-2:2004)

Gui

danceandmanufacturersd

eclarationelectromagneticimmunity

ThePSTP

erson

alCompactf

amilyisintend

edforuseintheelectromagneticenvironmentspecifiedbelow.


ersonalCom

pactf

amilyshouldassurethatitisusedinsuchanenvironment.

IEC

60601

testlevel

6kVconta

ct

8kVair

2kVforpo

wer

supplylines

1kVdifferentialmode

2kVcomm

onmode

Electromagneticenvironment

-guidance

Floorsshouldbewood,concreteorceramictile.Iffloorsare

coveredwithsyntheticmaterial,therelativehumidityshould

beatleast

30%.

Compliancelevel

6kVcontact

8kVair

2kVforpower

supplylines

Mainspowerqualityshouldbethatofatypicalcommercial

orhospital

environment.

1kVdiffer

entialmode

2kVcommonmode

Mainspowerqualityshouldbethatofatypicalcommercial

orhospital

environment.

Mainspow

erqualityshouldbethatofa

typicalcommercial

orhospitalenvironment.IftheuserofthePST

Personal

Compact

family

requirescontinued

operationduring

powerma

insinterruptions,itisrecom

mendedthatthe

PST

PersonalCompact

family

be

poweredfrom

an

uninterrupt

iblepowersupplyorabattery.

9

5%dipinUT)

for0,5cycle

40%UT(60

%dipinUT)

for5cycles

70%UT(30

%dipinUT)

for25cycles

9

5%dipinUT)

for5sec

3A/m

Powerfrequencymagneticfieldsshould

beatlevels

characteris

ticofatypicallocationinatyp

icalcommercialor

hospitalenvironment.

3

A/m

NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestleve

l.

Immu

nitytest

Electrostatic

discharge(ESD)

IEC61000-4-2

Electrostatic

transient/b

urst

IEC61000-4-4

Surge

IEC61000-4-5

Voltagedip

s,short

interruption

sandvoltage

variationso

npower

supplyinpu

tlinesIEC

61000-4-11

Powerfrequency(50/60

Hz)magneticfield

IEC61000-4-8

95%dipinUT)

for0,5cycle

40%UT(60

%dipinUT)

for5cycles

70%UT(30

%dipinUT)

for25cycles

95%dipinUT)

for5sec


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18

Table3Guidanceandmanufacturersdeclarationelectromagneticimmunity

forEQUIPMENTandSYS

TEM

th

atarenotLIFE-SUPPORTIN

G(see5.2.2.2inEN

60601-1-2:2004)

Guidanceandmanufacturersd

eclarationelectromagneticimmunity

ThePSTP

ersonalCompactf

amilyisintendedforuseintheelectromagnetic

environmentspecifiedbelow.


ersonalCompa

ctf

amilyshouldassurethat

itisusedinsuchanenvironm

ent.

IEC

60601

testlevel

3Veff

150kHzto

80MHz

3V/m

80MHzto

2,5GHz

Electromagneticen

vironment-guidance

Portableandmob

ileRFcommunicationsequipmentshouldbeusednoclose

rtoanypartofthe

PSTP

ersonalC

ompactf

amilyincludingcab

les,thantherecommendeds

eparationdistance

calculatedfromth

eequationapplicabletothefrequencyofthetransmitter.

Recommendeds

eparationdistance

P

d

2,

1

=

/

P

d

2,

1

=

for80MHzbis800M

Hz/

P

d

3,

2

=

for800MHz

bis2,5

GHz

wherepisthema

ximumoutputpowerratingof

thetransmitterinwatts(W)accordingtothe

transmittermanufactureranddistherecommendedseparationdistanceinm

etres(m).

Fieldstrengthsfro

mfixedRFtransmitters,asdeterminedbyanelectromagne

ticsitesurvey,a

shouldbelesstha

nthecompliancelevelineachfrequencyrange.b

Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowing

symbol:

Co

mpliance

level

3Veff

3V/m

Immuni

tytest

Conducted

RF

IEC61000-

4-6

RadiatedR

F

IEC61000-

4-3

NOTE1At

80MHzand800MHz,thehig

herfrequencyrangeapplies.

NOTE2Th

eseguidelinesmaynotapply

inallsituations.Electromagneticisaffectedbyabsorptiona

ndreflectionfromstructures,

objectsand

people.

aF

ieldstren

gthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephone

sandlandmobileradios,amateurradio,AMand

FMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRF

transmitters

,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichthePSTP

ersonalCompact

familyisus

edexceedstheapplicableRF

compliancelevelabove,thePSTP

ersonalCompactf

am

ilyshouldbeobservedtoverifynormaloperation.

Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingor

relocatingthePSTP

ersonalCompactf

amily.

bOverthefrequencyrange150kHzto80MHz,

fieldstrengthsshouldbelessthan3V/m.


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19

Table4RecommendedseparationdistancesbetweenportableandmobileR

Fcommunicationsequipme

nt

andtheEQUIPMENTorSYSTEM-

forEQUIPMENTandSYSTE

MSthatarenotLIFE-SUPPO

RTING(see5.2.2.2inEN60601-1-2:2004)

Fortransmittersratedatamaximumoutp

utpowernotlistedabovethe

recommendedseparationdis

tancedinmetres(m)canbeestimatedusing

theequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts

(W)accordingto

thetransmittermanufacturer.

0,01

0,12

0,12

0,23

0

,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

1

00

12

12

23

Rec

ommendedseparationdistancesbetweenportableand

mobileRF

communicationsequipmentandthePSTP

ersonalComp

actf

amily

ThePSTPersonalCompactfamilyis

intendedforuseinanelectromagneticenvironmentinwh

ichradiatedRFdisturbances

arecontrolled.The

customerortheuserofthePSTP

ersona

lCompactf

amilycanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetween

portablean

dmobileRFcommunications

equipment(transmitters)andthePST

PersonalCompactf

amilyasrecommendedbelow,accordingtothe

maximumo

utputpowerofthecommunicationsequipment.

150kHzto80MHz

80MHzto800MHz

800MHzto2,5GHz

Ratedmaximum

outputoftransmitterW

Separationd

istanceaccordingtofrequencyoftransmitterm

P

d

2,

1

=

P

d

2,

1

=

P

d

3,

2

=

NOTE1At

80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.

NOTE2Th

eseguidelinesmaynotapply

inallsituations.Electromagneticpropagationisaffectedby

absorptionandreflectionfrom

structures,

objectsand

people.


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Groupe President Medical

Route de Ste - BP 100 - 34540 Balaruc / France

Tel. : +33 (0)4.67.46.36.96 - Fax : +33 (0)4.67.46.27.09E-mail : [email protected]

Website : www.pst-original.comM

21.00.10V4

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