INSTRUCTION MANUAL

for

the original PST Personal Compact family

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

PRESENTATION
Thank you for choosing the PST Personal Compact family. PST (Pulsed Signal Therapy) treatment devices have been developed based on decades of scientic research and are now manufactured in 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)

Instruction Manual

PST Applicator Chipcard

(in plastic case) (inside the glove)

PST DVD

PST Personal Compact

Power cable (inside the glove)

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PST INDICATIONS
The PST Personal Compact was developed for the treatment of musculoskeletal disorders, particularly osteoarthritis (arthrosis), including degenerative joint diseases, and posttraumatic or postoperative disorders in jointrelated 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 benet can be derived from supplementary 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): Shoulder Neck

Wrist

Lower Back Hip

Elbow

Hand

Knee

Ankle Foot 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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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 intensication 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 treatment as prescribed by you physiotherapist, additionally to optimize the success of PST.

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 and its 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 6

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

DO NOT INTERRUPT THE TREATMENT FOR MORE THAN 48 HOURS

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

DO NOT REMOVE THE APPLICATOR FROM THE JOINT DURING THE SESSION
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USER STEPS
1 - Plug in a) Applicator jack b) Push tight

For removal press red button rmly

c) Power cable, note position

d) Connect to the mains or wall power source

2 - Position the applicator

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

Wrist

Hand

Neck
No stretched leg

Knee
No bended leg

Hip

Lower Back

Ankle

Foot

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3 - Switch ON: power I position

I = ON
CONNECT TO POWER SUPPLY

LED lights up

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

Number of sessions left

5 - Press START button Number of minutes left Please ensure that you are ready to start. Once you push the start button, one unit will be debited from chipcard 6End of session Beep signal: remove applicator from the joint 7Switch OFF: power O position* 0 = OFF
DISCONNECT FROM POWER SUPPLY

Active light start: session OK

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TROUBLESHOOTING
DESCRIPTION The green light does not light up ILLUSTRATION ACTION Ensure that the power cable is tted correctly. Check the fuses The internal safety shutdown has been triggered.Switch the device OFF for approx. 10 minutes and then ON again Put the card in the slot in the prescribed position Your sessions of treatment are complete. If you need another therapy, insert a new card

The START button does not function properly

E1 appears in the LED screen

E2 appears in the LED screen, your card is empty

EE appears in the LED screen, Applicator malfunction

Contact the After-Sales Service

E9 appears in the LED screen

Unit must be serviced by GPM (Groupe President Medical) technician

If you detect a fault that persists do not continue using the device!
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CHANGE OF FUSES
Please observe the following steps when you change the fuses
1. Switch off the PST controller 8. Carefully put the new fuses in the holder (both fuses have to be parallel but the orientation doesnt matter)

2 Disconnect from the mains or wall power source 3. Unplug applicator jack and power cable 9. Put the fuse holder back in the device a) Put the holder in place b) Press the lid down

4. Open the fuse lid (you may use a screwdriver or a pen)

5. Remove the fuse holder

10. The holder must be aligned with the surface area

11. Plug in the applicator jack and the power cable 6. Take the old fuses out and throw them away

12. Connect power cable to the mains or wall power source 7. Take 2 new fuses from the plastic bag attached to the user manual Fuse T 1.25A (250 V) / 5x20mm

13. Switch the compact on LED light up If not please repeat steps 1-13. If no positive result call the GPM after sales-service.

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TECHNICAL DATA

General: Size and Weight PST Personal Compact device Power:

(W) 220 mm (D)180 mm (H) 75 mm - weight 0,900 kg 50/60 Hz - 100/240 V AC I max: 1,25A - Fuse T 1,25A Umax : 24 V PP

Output Environmental conditions: Atmospheric pression Temperature Atmospheric humidity Storage and transport conditions: Atmospheric pression Temperature Atmospheric humidity

500 hPa ~ 1060 hPa +5 ~ +40C 35% ~ 80% not condensed 500 hPa ~ 1060 hPa -10C ~ +50C 10% ~ 90% not condensed

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). 0123
Declaration of conformity with European market standards

Symbol for Grounding/ Grounding equipment conductor connection

Device with type B application part

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

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WARRANTY - AFTER-SALES SERVICE

The PST Personal Compact product line is covered by a standard limited Groupe President Medical (GPM) 2-year standard limited-warranty from the purchase date. The warranty covers all the material defects and manufacturing faults associated with the product. Only customers who bought their product from GPM or from a GPM 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; products with removed, damaged or modied labels and safety stickers; malfunctions caused by other devices or improper use that does not comply with instructions provided in the user manual. In order to apply the warranty, please contact the GPM after-sales service either per e-mail compact-support@president-medical.com 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 it is conrmed the unit is still inside the 2-year warranty period, you will be given a case number for reference. You have to include this number with your product when you return it to GPM. The product is to be sent back to GPM packaged appropriately in the original packaging (or any other packaging which guarantees equivalent 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 to determine the root cause of the problem, and If they determine the problem is due to material defects and/or manufacturing faults the product will be repaired or replaced and shipped back to you at no cost If they determine the problem is due to conditions not included in the limited warranty, they will estimate repair charges and contact you via email or phone to get your approval for the repairs/replacements. If you authorize the repair you will be invoiced and the repaired unit will be shipped back to you on receipt of payment by GPM or an authorized agent. During the initial contact with the after-sales service if it is determined that the standard warranty period has expired, you still have the option of sending the unit back for inspection and repair. In this case you will be provided a cost estimate for 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 the cost estimate and receipt of payment. For professional use: the PST Personal Compact device should be inspected by an approved Groupe President Medical service center 2-years after purchase and every 2-years thereafter. See our Website for locations of Service Centers.
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Compliance Electromagnetic environment - guidance Group 1 The PST Personal Compact family uses RF energy only for its internal function. Therefor, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B Class A The PST Personal Compact family, is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Complies

Table 1 Guidance and manufacturers declaration electromagnetic emissions for all EQUIPMENT AND SYSTEMS (see 5.2.2.2 in EN 60601-1-2:2004)

Guidance and manufacturers declaration electromagnetic emissions

The PST Personal Compact family is intended for use in the electromagnetic environment specied below. The customer or the user of the PST Personal Compact family should assure that it is used in such an environment.

Emissions test

RF emissions CISPR 11

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage uctuations / icker emissions IEC 61000-3-3

Table 2 Guidance and manufacturers declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS (see 5.2.2.2 in EN 60601-1-2:2004)

Guidance and manufacturers declaration electromagnetic immunity

The PST Personal Compact family is intended for use in the electromagnetic environment specied below. The customer or the user of the PST Personal Compact family should assure that it is used in such an environment. Compliance level Electromagnetic environment - guidance

Immunity test

IEC 60601 test level 6 kV contact 8 kV air

Electrostatic discharge (ESD) IEC 61000-4-2 2 kV for power supply lines 1 kV differential mode 2 kV common mode

6 kV contact 8 kV air

Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

Electrostatic transient / burst IEC 61000-4-4

2 kV for power supply lines

Surge IEC 61000-4-5

1 kV differential mode 2 kV common mode

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT ) for 5 cycles 70 % UT (30 % dip in UT ) for 25 cycles < 5 % UT (>95 % dip in UT) for 5 sec

< 5 % UT (>95 % dip in UT ) for 0,5 cycle 40 % UT (60 % dip in UT ) for 5 cycles 70 % UT (30 % dip in UT ) for 25 cycles < 5 % UT (>95 % dip in UT ) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the PST Personal Compact family requires continued operation during power mains interruptions, it is recommended that the PST Personal Compact family be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a. c. mains voltage prior to application of the test level.

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Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the PST Personal Compact family including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Table 3 Guidance and manufacturers declaration electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING (see 5.2.2.2 in EN 60601-1-2:2004)

Guidance and manufacturers declaration electromagnetic immunity

The PST Personal Compact family is intended for use in the electromagnetic environment specied below. The customer or the user of the PST Personal Compact family should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 Veff

d = 1,2 P / d = 1,2 P for 80 MHz bis 800 MHz / d = 2,3 P for 800 MHz bis 2,5 GHz
where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reection from structures, objects and people.

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the PST Personal Compact family is used exceeds the applicable RF compliance level above, the PST Personal Compact family should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PST Personal Compact family.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Table 4 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 5.2.2.2 in EN 60601-1-2:2004)

Recommended separation distances between portable and mobile RF communications equipment and the PST Personal Compact family

The PST Personal Compact family is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PST Personal Compact family can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PST Personal Compact family as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 800 MHz to 2,5 GHz

Rated maximum output of transmitter W

150 kHz to 80 MHz

d = 1,2 P
0,12 0,38 1,2 3,8 12 1,2 3,8 12 0,38 0,12

d = 1,2 P

d = 2,3 P
0,23 0,73 2,3 7,3 23

0,01

0,1

10

100

For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.

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QM 21.00.10 V4

Groupe President Medical Route de Ste - BP 100 - 34540 Balaruc / France Tel. : +33 (0)4.67.46.36.96 - Fax : +33 (0)4.67.46.27.09 E-mail : compact-support@president-medical.com Website : www.pst-original.com