COMBI 200L User Manual ver 1.0 Nov 2004

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Combi 200L

© 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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Combi 200L

User Manual Combi 200L Device for electrotherapy, ultrasound therapy, combination therapy and laser 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 1.0 November 2004

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

Accomodation Quotient Constant Current Combination therapy Courte Période Constant Voltage Diphasé Fixe Electrode Electromagnetic Compatibility Electrostatic Discharge Electrotherapy Hospital Antiseptic Concentrate Laser therapy 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 Sensitive to electrostatic discharge

Read the manual Manufacturer

Symbols on the laser probe Points to laser aperture and shows direction of beam

Laser warning sign

Type B applied part

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Symbols in the manual Warning or important information.

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TABLE OF CONTENTS 1

SAFETY ... 9 1.1 PURPOSE ... 9 1.2 SAFETY INSTRUCTIONS ... 9 1.3 MEDICAL DEVICES DIRECTIVE ... 12 1.4 LIABILITY ... 13

2

INSTALLATION ... 15 2.1 RECEIPT ... 15 2.2 PLACING AND CONNECTION ... 15 2.3 PERFORMING THE FUNCTIONAL TEST ... 15 2.4 SETTING CONTRAST AND SELECTING LANGUAGE ... 15 2.5 TRANSPORT AND STORAGE ... 16 2.6 RESELLING ... 16

3

DESCRIPTION OF THE EQUIPMENT ... 17 3.1 COMBI 200L AND ACCESSORIES ... 17 3.2 COMPONENTS OF COMBI 200L ... 18 3.3 DISPLAY ... 19 3.4 DISPLAY SYMBOLS ... 20 3.5 SYMBOLS FOR CURRENT SHAPES IN MEMORY MENU ... 20 3.6 PARAMETER SYMBOLS ... 21 3.7 CURRENT SHAPES ... 22

4

OPERATION ... 25 4.1 THERAPY SELECTION ... 25 4.2 PERFORMING THERAPY ... 28 4.3 ELECTROTHERAPY ... 30 4.4 ULTRASOUND THERAPY ... 38 4.5 COMBINATION THERAPY ... 40 4.6 LASER THERAPY ... 41 4.7 DIAGNOSTIC PROGRAMS ... 43 4.8 PROGRAMS ... 45 4.9 SYSTEM SETTINGS ... 47

5

INSPECTIONS AND MAINTENANCE ... 53 5.1 INSPECTIONS ... 53 5.2 MAINTENANCE ... 55

6

MALFUNCTIONS, SERVICE AND GUARANTEE ... 57 6.1 MALFUNCTIONS ... 57 7

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Combi 200L 6.2 6.3 6.4

SERVICE ... 58 GUARANTEE ... 58 TECHNICAL LIFE TIME ... 59

7

TECHNICAL INFORMATION ... 61 7.1 GENERAL ... 61 7.2 ELECTROTHERAPY ... 61 7.3 ULTRASOUND THERAPY ... 64 7.4 LASER THERAPY ... 65 7.5 ENVIRONMENTAL CONDITIONS ... 66 7.6 TRANSPORT AND STORAGE ... 66 7.7 STANDARD ACCESSORIES ... 67 7.8 OPTIONAL ACCESSORIES ELECTROTHERAPY ... 68 7.9 OPTIONAL ACCESSORIES ULTRASOUND THERAPY ... 69 7.10 OPTIONAL ACCESSORIES LASER THERAPY ... 69

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APPENDICES ... 71 8.1 AGENTS FOR IONTOPHORESIS ... 71 8.2 DIAGNOSTIC I/T-CURVE ... 72 8.3 EMC DIRECTIVE ... 73 8.4 TECHNICAL SAFETY INSPECTION ... 77 8.5 DISPOSAL ... 82

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REFERENCE ... 83 9.1 FUNCTION OVERVIEW ... 83 9.2 LITERATURE ... 91 9.3 TERMINOLOGY ... 91

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INDEX ... 95

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1

SAFETY

1.1

Purpose

The Combi 200L is intended solely for medical applications. You can use the Combi 200L for electrotherapy, ultrasound therapy, combination therapy and laser 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. 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 • •

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.

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1.2.7

Laser therapy

The laser is a class 3b laser product and has an invisible beam.

• Make sure the laser warning sign is clearly visible outside the entrance to the therapy room.

• The radiation of a laser probe can cause a physiological effect. • Use the laser therapy only for therapeutic purposes. • Use of controls or adjustments or performance of procedures •

• • • • • •

• • 1.3

other then those specified in this manual may result in hazardous radiation exposure. Start a laser therapy only when all persons in the room wear laser goggles for eye protection. If you do not obey this warning, you can cause blindness. Use goggles with at least the characteristics: I 100 - 1000 L2 and with a clear view of the control, the display and the signal lights. See §7.10. Do not look into the laser beam during a laser therapy. Do not point the laser beam into eyes. Do not use the laser near flammable materials or liquids. Do not use the equipment if any damage shows. Regulary check the output of the laser probe with the test facility. See §4.9.8. Check the laser probe at least once a month. During the check, look for dents, cracks and other damage. Check whether the insulation of the cable is still intact. Check whether all pins are present and straight in the connectors. Replace the laser probe if the laser, the cable or the connector is damaged. See §5.1. Place the laser probe in the holder when the laser is not used. Remove the key of the laser lock when the laser therapy is not used.

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. • 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.

2.4 1. 2. 3. 4. 5. 6.

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.

Setting contrast and selecting language Press for 5 seconds. The System setting menu appears. See §4.9. Press next to Contrast, 1st key from the top. If necessary, change the contrast with and . Press next to Language. If necessary, change the language with and . Press to return to the start menu.

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2.5

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.

2.6

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

Combi 200L and accessories 12

11

1

2

10

6

3

9

4

8 5

7

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

7.

EL sponges for rubber electrode (4 pieces) 8. Elastic fixation straps (4 pieces) 9. VAS score card 10. Rubber electrodes (4 pieces) 11. Two-ply electrode cable (2 pieces) 12. Test connector

Combi 200L. See §3.2. Power cord Laser goggles. Optional accessory. See §7.10. Laser probe. Optional accessory. See §7.10. US head Contact gel

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3.2

Components of Combi 200L 1

2 3 4 5

19

6 7 8

A

A

18 17 16

B

!

B

9 10 11 12 13 14 15

20 21 22 23

24

25 26

A

B

27 28 29 30 31 32

19. Select parameter or menu 20. Connector for US head 21. On/off switch 22. Connection to mains supply 23. Type plate 24. Ventilation opening 25. Fuse holder 26. Indication: Floating patient circuit 27. Laser lock 28. Connector for laser probe 29. Connector for electrotherapy, channel A 30. Indicator lamp for channel A 31. Connector for electrotherapy, channel B 32. Indicator lamp for channel B

1. Display. See §3.3. 2. Electrotherapy 3. Ultrasound therapy 4. Combination therapy 5. Laser therapy 6. Memory 7. Start menu 8. Channel selection: A or B 9. Stop 10. Intensity of channel A 11. Pause 12. Laser test eye 13. Return to previous menu 14. Intensity of channel B 15. Enter 16. Indication: Read manual 17. Down 18. Up

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3.3

Display

1

2

3

4

5

US+Conv. TENS

9

10 11 12

15:00

Pulse time

34 40

s

red+ 0

CV

Pulse form Min. frequency

6

80 Hz

Max. frequency 100 Hz

13

set0.0

Sweep mode

0.0

Treatment time

15:00

Perceptibe, comfortable

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

8. 9.

7

Explanation or recommendation Screen for channel A (here, electrotherapy). See §4.3.5. 10. Remaining treatment time 11. Polarity 12. Set intensity 13. Screen for channel B (here, ultrasound therapy). See §4.4.2.

Channel Therapy Current shape Title of the screen Program number Parameters with selection knobs Use to go to the next parameters

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3.4

Display symbols

3.4.1

General Electrotherapy

A

Channel A

Ultrasound therapy

B

Channel B

Combination therapy

A+B

Laser therapy

SEQ 3.4.2

3.5

Channel A and B simultaneously Treatment time

Sequential current shapes

0:00 Treatment completed

Current shape groups Unidirectional currents

2-pole medium frequency

Diadynamic

4-pole Interferential

TENS currents

4-pole interferential with vector

NMES currents

Diagnostic programs

Symbols for current shapes in memory menu Medium frequency unidirectional current

Burst TENS

Unidirectional rectangular current

Rectangular surge current

Unidirectional triangular current

Triangular surge current

Conventional TENS

Biphasic surge current

Low frequency TENS

Intrapulse interval surge current

Random TENS

2-pole medium frequency surge current 20