phyaction c User Manual Ver 1.1 Feb 2005

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Phyaction C

© 2004, GymnaUniphy N.V. All rights reserved. Nothing from this publication may be copied, stored in an automated data file, or made public, in any form or in any way, be it electronically, mechanically, by photocopying, recordings or in any other way, without prior written permission from GymnaUniphy N.V.

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User Manual Phyaction C Device for electrotherapy, ultrasound therapy and combined therapy Manufacturer Main office Telephone Fax E-mail Website

GymnaUniphy N.V. Pasweg 6A B-3740 BILZEN +(32) (0)89-510.510 +(32) (0)89-510.511 [email protected] www.gymna-uniphy.com

Version 1.1 February 2005 3

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Abbreviations AQ CC CO CP CV DF EMC ESD EL ET HAC LP MF MTP NMES TENS US VAS

Accomodation Quotient Constant Current Combination therapy Courte Période Constant Voltage Diphasé Fixe Electromagnetic Compatibility Electrostatic Discharge Electrode Electrotherapy Hospital Antiseptic Concentrate Longue Période Medium Frequency: with unidirectional and interferential currents Monophasé Fixe: with diadynamic currents Myofascial Trigger Point Neuro Muscular Electro Stimulation Transcutaneous Electrical Nerve Stimulation Ultrasound Visual Analogue Scale

Symbols on the equipment

Read the manual.

Symbols in the manual

Warning or important information.

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TABLE OF CONTENTS 1

SAFETY ... 7 1.1 PURPOSE ... 7 1.2 SAFETY INSTRUCTIONS ... 7 1.3 MEDICAL DEVICES DIRECTIVE ... 9 1.4 LIABILITY ... 10

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INSTALLATION ... 11 2.1 RECEIPT ... 11 2.2 PLACING AND CONNECTION ... 11 2.3 PERFORMING THE FUNCTIONAL TEST ... 11 2.4 SETTING CONTRAST, LANGUAGE AND STAND-BY TIME ... 11 2.5 USE IN COMBINATION WITH AN OTHER DEVICE ... 12 2.6 TRANSPORT AND STORAGE ... 12 2.7 RESELLING ... 12

3

DESCRIPTION OF THE EQUIPMENT ... 13 3.1 PHYACTION C AND STANDARD ACCESSORIES ... 13 3.2 COMPONENTS OF PHYACTION C ... 14 3.3 DISPLAY ... 15 3.4 DISPLAY SYMBOLS ... 16 3.5 SYMBOLS FOR CURRENT SHAPES ... 16 3.6 PARAMETER SYMBOLS ... 17 3.7 CURRENT SHAPES ... 18

4

OPERATION ... 21 4.1 THERAPY SELECTION ... 21 4.2 SELECTION BY THE THERAPY MENU ... 21 4.3 SELECTION BY THE GUIDE MENU ... 22 4.4 PERFORMING THERAPY ... 24 4.5 ELECTROTHERAPY ... 26 4.6 ULTRASOUND THERAPY ... 34 4.7 COMBINATION THERAPY ... 37 4.8 DIAGNOSTIC PROGRAMS ... 38 4.9 MEMORY ... 40 4.10 SYSTEM SETTINGS ... 42

5

INSPECTIONS AND MAINTENANCE ... 47 5.1 INSPECTIONS ... 47 5.2 MAINTENANCE ... 49

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MALFUNCTIONS, SERVICE AND GUARANTEE ... 51 6.1 MALFUNCTIONS ... 51 6.2 SERVICE ... 52 6.3 GUARANTEE ... 52 6.4 TECHNICAL LIFE TIME ... 53

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TECHNICAL INFORMATION ... 55 7.1 GENERAL ... 55 7.2 ELECTROTHERAPY ... 55 7.3 ULTRASOUND THERAPY ... 58 7.4 ENVIRONMENTAL CONDITIONS ... 60 7.5 TRANSPORT AND STORAGE ... 60 7.6 STANDARD ACCESSORIES ... 61 7.7 OPTIONAL ACCESSORIES ELECTROTHERAPY ... 62 7.8 OPTIONAL ACCESSORIES ULTRASOUND THERAPY ... 63

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APPENDICES ... 65 8.1 AGENTS FOR IONTOPHORESIS ... 65 8.2 DIAGNOSTIC S-D CURVE ... 66 8.3 ELECTRODE AND US HEAD PLACEMENTS ... 67 8.4 EMC DIRECTIVE ... 70 8.5 TECHNICAL SAFETY INSPECTION ... 74 8.6 DISPOSAL ... 78

9

REFERENCE ... 79 9.1 FUNCTION OVERVIEW ... 79 9.2 LITERATURE ... 85 9.3 TERMINOLOGY ... 85

10

INDEX ... 89

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1

SAFETY

1.1

Purpose

The Phyaction C is intended solely for medical applications. You can use the Phyaction C for electrotherapy, ultrasoundtherapy and combined therapy. The device is suited for continuous use.

1.2

Safety instructions

1.2.1

General

• Only qualified people who are trained in the application of the therapies may use the appliance.

• Only a technician authorised by GymnaUniphy N.V. may open the equipment or the accessories.

• Follow the instructions and directions in these user instructions.

• Place the equipment on a horizontal and stable base. • Keep the ventilation openings at the bottom and rear of the equipment free.

• Do not place any objects on the equipment. • Do not place the equipment in the sun or above a heat source. • Do not use the equipment in a damp area. • Do not let any liquid flow into the equipment. • Do not disinfect or sterilise the equipment. Clean the equipment with a dry or moistened cloth. See §5.

• Only treat patients with electrical implants (pacemaker) after obtaining medical advice.

• The 'Directive on Medical Devices' from the European

•

•

Commission (93/42/EEG) requires that safe devices are used. It is recommended to perform a yearly technical safety inspection. See §5.1.2. For optimum treatment, a patient investigation must first be performed. On the basis of the findings of the investigation, a treatment plan with objectives will be formulated. Follow the treatment plan during the therapy. This will limit possible risks, related to the treatment, to a minimum. Always keep these user instructions with the equipment.

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1.2.2

Electrical safety

• Only use the equipment in an area with facilities that meet the applicable legal regulations.

• Connect the equipment to an outlet with a protective earth terminal. The outlet must meet the locally applicable requirements for medical areas.

1.2.3

Prevention of explosion

• Do not use the equipment in an area where combustible gases or vapours are present.

• Switch off the equipment when it is not used. 1.2.4

Electro Magnetic Compatibility

• Medical electrical equipment requires special precautions for • •

Electro Magnetic Compatibility (EMC). Follow the instructions for the installation of the equipment. See §2 Do not use mobile telephones or other radio, shortwave, or microwave equipment in the vicinity of the equipment. This kind of equipment can cause disturbances. Only use the accompanying accessories that are supplied by GymnaUniphy. See §7.6, §7.7 and §7.8. Other accessories can lead to an increased emission or a reduced immunity.

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1.2.5

Electrotherapy

• Do not use the equipment simultaneously with high frequency •

• •

• 1.2.6

surgical equipment. This combination can cause burning of the skin under the electrodes. Do not use adhesive electrodes with currents that have a galvanic component, such as galvanic, diadynamic, MF rectangular, pulsed rectangular and triangular currents. With these currents, etching of the skin can occur. Check the electrode cables and the electrodes at least once a month. Check whether the insulation is still intact. See §5.1. The safety standards for electrical stimulation advise not to exceed the current density of 2.0 mArms/cm2. However, with iontophoresis treatments, we advise a maximum current density of 0.25 mÂ/cm2, because of using the MF rectangular current. Exceeding this value can result in skin irritation and burns. Always use sterilised gauze with iontophoresis treatments.

Ultrasound therapy

• Move the US head evenly over the skin during the treatment. This prevents internal burns.

• The US treatment heads are exchangeable. The device • •

1.3

detects the characteristics and supplies the right power at the right frequency. Handle the US heads carefully. With rough handling, the characteristics can change. Test the US head if it falls on the ground or knocks against something. See §5.1.1. Check the US head at least once a month. During the check, look for dents, cracks and other damage that could allow liquids to ingress. Check whether the insulation of the cable is still intact. Check whether all pins are present and straight in the connectors. Replace the US head if the head, the cable or the connector is damaged. See §5.1.

Medical Devices Directive

The device complies with the essential requirements of the Medical Device Directive of the European Committee (93/42/EEC) as most recently changed.

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1.4

Liability

The manufacturer cannot be held liable for injury to the therapist, the patient or third parties, or for damage to or by the equipment used, if for example: • an incorrect diagnosis is made; • the equipment or the accessories are used incorrectly; • the user instructions are wrongly interpreted or ignored; • the equipment is badly maintained; • maintenance or repairs are performed by people or organisations that are not authorised to do so by GymnaUniphy. Neither the manufacturer nor the local GymnaUniphy dealer can be held liable, in any way whatsoever, for the transfer of infections via the vaginal, anal and rectal probes and/or other accessories.

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2 2.1 1. 2.

2.2

INSTALLATION Receipt Check whether the equipment has been damaged during transport. Check whether the accessories are intact and complete. See §7.6, §7.7 and §7.8. • Inform your supplier of any damage or defects by no later than within 3 working days after receipt. Report the damage by telephone, fax, e-mail or letter. • Do not use the equipment if it is damaged or defective.

Placing and connection

1.

Place the equipment on a horizontal and stable base. • Keep the ventilation openings at the bottom and rear of the equipment free. • Do not place the equipment in the sun or above a heat source. • Do not use the equipment in a wet area.

2.

Check whether the mains voltage that is stated on the rear of the equipment corresponds with the voltage of your mains supply. The equipment is suited for a nominal mains voltage from 100 V to 240 VAC / 50-60 Hz. Connect the device to an outlet with protective earth terminal.

3.

2.3 1. 2.

3.

Performing the functional test Switch the equipment on with the switch at the rear of the equipment. When the equipment is switched on, it automatically performs a test. Check whether the indicator lamps next to A and B light briefly during the test. If the lamps do not light up: See §6.

2.4

Setting contrast, language and stand-by time

1. 2. 3. 4. 5. 6. 7. 8.

Press . The System settings menu appears. See §4.10. Select Contrast with the corresponding blue key , 1st key in the row. If necessary, change the contrast with and . Select Language with the corresponding blue key . If necessary, change the language with and . Select Stand-by time with the corresponding blue key . If necessary, change the stand-by time with and . Press to return to the Guide menu. guide

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2.5

Use in combination with an other device

The Phyaction C can be used in combination with the Phyaction V. For information about the use of the Phyaction C with the Phyaction V, refer to the Phyaction V user manual.

2.6

Transport and storage

Take account of the following matters if the equipment has to be transported or stored: • Transport or store the equipment in the original packaging. • The maximum period for transport or storage is: 15 weeks. • Temperature: -20 °C to +60 °C. • Relative humidity: 10% to 100%. • Atmospheric pressure: 200 hPa to 1060 hPa.

2.7

Reselling

This medical equipment must be traceable. The equipment, the US head and some other accessories have a unique serial number. Provide the dealer with the name and address of the new owner.

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3

DESCRIPTION OF THE EQUIPMENT

3.1

Phyaction C and standard accessories 10

1

2

9

8

3

7

1. 2. 3. 4. 5. 6.

6

5

7.

4

EL sponges for rubber electrode (4 pieces) 8. Rubber electrodes (4 pieces) 9. Two-ply electrode cable (2 pieces) 10. Test connector

Phyaction C. See §3.2. Power cord Contact gel US head VAS score card Elastic fixation straps (4 pieces)

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3.2

Components of Phyaction C 1

19

20

4 5 2 3 11 10 12 9

6 7 8 13

18 15

17 14

16

21 22 23 24 25 20

A

B

26 27 28 29

17. Indicator lamp device on/off 18. Indication: Read manual 19. Connectors for US head 20. Indication: Floating patient circuit 21. On/off switch 22. Fuse holder 23. Connection to mains supply 24. Type plate 25. Ventilation opening 26. Connector for electrotherapy, channel A 27. Indicator lamp for channel A 28. Connector for electrotherapy, channel B 29. Indicator lamp for channel B

1. 2.

Display. See §3.3. Select menu option or parameter 3. Scroll through the list/numbers 4. Increase or set a parameter 5. Decrease or set a parameter 6. Therapy menu 7. Guide menu 8. Memory menu 9. System settings menu 10. Back 11. Pause 12. Stop 13. Select channel A 14. Select channel B 15. Intensity of channel A 16. Intensity of channel B

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3.3

Display

1

2

3

4

5

9 10 11

6

8

12 7

14

13 1. 2. 3. 4. 5. 6. 7. 8.

9. Remaining treatment time 10. Polarity 11. Set intensity 12. Screen for channel B (here, ultrasound therapy). See §4.6.3. 13. Numbers, selection with the blue keys below display. 14. Scroll through numbers with the blue keys and .

Selected channel Title of the screen Program number Therapy Current shape Parameters of the selected channel Explanation or recommendation Screen for channel A (here, electrotherapy). See §4.5.5.

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3.4

Display symbols

3.4.1

General Electrotherapy

SEQ

Ultrasound therapy

A

Channel A

Combination therapy

B

Channel B

Treatment time

0:00 Treatment completed

3.4.2

Sequential current shapes

A+B

Channel A and B simultaneously

A

Alternating channels

B

Current shape groups Unidirectional currents

2-pole medium frequency

Iontophoresis

Dipole vector field

Diadynamic

Isoplanar vector field

TENS currents

Diagnostic programs

NMES currents

3.5

Symbols for current shapes Medium frequency unidirectional current

Rectangular surge current

Unidirectional rectangular current

Triangular surge current

Rectangular pulse

Biphasic surge current

Unidirectional triangular current

Intrapulse interval surge current

Triangular pulse

2-pole medium frequency surge current 16

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Conventional TENS

Russian stimulation

Low frequency TENS

2-pole medium frequency

Random TENS

Dipole vector field

Burst TENS

Isoplanar vector field

CP

CP (diadynamic)

DF

DF (diadynamic)

LP

LP (diadynamic)

MF

MF (diadynamic)

S-D S-D

S/d curve rectangular S/d curve triangular S/d curve rectangular +

S-D triangular CHR AQ

Rheobase and chronaxie Rheobase and AQ

3.6

Parameter symbols

3.6.1

Electrotherapy

Red+ Red-

Polarity indication

CC

Constant Current

-

Alternating polarity

CV

Constant Voltage

Biphasic pulse shape, symmetrical

mA

mA peak

Biphasic pulse shape, asymmetrical

V

Volt peak

+

Frequency sweep mode 12

12s/12s

6

6s/6s

1

1 5

12

1

6

17

5

1s/5s -1s/5s

1

1s/1s

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3.6.2 10% 20% 30% 40% 50% 100%

set

Ppk

Ultrasound therapy US duty cycle 10%

1:10 ms US on : period time 10%

US duty cycle 20%

2:10 ms US on : period time 20%

US duty cycle 30%

3:10 ms US on : period time 30%

US duty cycle 40%

4:10 ms US on : period time 40%

US duty cycle 50%

5:10 ms US on : period time 50%

US duty cycle 100%

10:10 ms US on : period time 100%

Set US intensity

US head, ERA 4 cm2

Peak US output power

US head, ERA 1 cm2

Unit of the set US

W /cm2 intensity 3.7

Current shapes

3.7.1

Unidirectional currents

2 ms

Rectangular pulse current

Triangular pulse current

2-5 current (UltraReiz)

Medium frequency rectangular current

5 ms

3.7.2

Diadynamic currents MF

CP MF

DF

MF

DF

DF

LP

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3.7.3

Interferential currents Dipole vector field

2-pole medium frequency

Isoplanar vector field

3.7.4

3.7.5

TENS currents Conventional TENS, asymmetrical

Conventional TENS, alternating symmetrical

Conventional TENS, alternating asymmetrical

TENS burst

Conventional TENS, symmetrical

TENS burst, alternating

NMES currents Rectangular surge current

Biphasic surge current

Triangular surge current

Intrapulse interval surge current

Medium frequency surge current

Russian stimulation

Isoplanar vector field surge

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