GymnaUniphy Combi 200L User manual

User Manual

COMBI 200L

Combi 200L

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.

Combi 200L

User Manual Combi 200L

Device for electrotherapy, ultrasound therapy, combination therapy and laser therapy

Manufacturer GymnaUniphy N.V. Main office Pasweg 6A

B-3740 BILZEN Telephone +(32) (0)89-510.510 Fax +(32) (0)89-510.511 E-mail info@gymna-uniphy.com Website www.gymna-uniphy.com

Version 1.0 November 2004

Combi 200L

Abbreviations

AQ Accomodation Quotient CC Constant Current CO Combination therapy CP Courte Période CV Constant Voltage DF Diphasé Fixe EL Electrode EMC Electromagnetic Compatibility ESD Electrostatic Discharge ET Electrotherapy HAC Hospital Antiseptic Concentrate LA Laser therapy LP Longue Période MF Medium Frequency: with unidirectional and interferential currents

Monophasé Fixe: with diadynamic currents MTP Myofascial Trigger Point NMES Neuro Muscular Electro Stimulation TENS Transcutaneous Electrical Nerve Stimulation US Ultrasound VAS Visual Analogue Scale

Symbols on the equipment

Read the manual

Manufacturer

Symbols on the laser probe

Laser warning sign

Type B applied part

Sensitive to electrostatic discharge

Points to laser aperture and shows direction of beam

Symbols in the manual

Warning or important

information.

Combi 200L

TABLE OF CONTENTS

1 SAFETY ............................................................................................ 9

1.1 P

1.2 S

1.3 M

1.4 L

2 INSTALLATION .............................................................................. 15

2.1 R

2.2 P

2.3 P

2.4 S

2.5 T

2.6 R

3 DESCRIPTION OF THE EQUIPMENT ............................................ 17

3.1 C

3.2 C

3.3 D

3.4 D

3.5 S

3.6 P

3.7 C

URPOSE .................................................................... 9

AFETY INSTRUCTIONS ................................................... 9

EDICAL DEVICES DIRECTIVE ......................................... 12

IABILITY .................................................................. 13

ECEIPT .................................................................... 15

LACING AND CONNECTION ........................................... 15

ERFORMING THE FUNCTIONAL TEST ................................. 15

ETTING CONTRAST AND SELECTING LANGUAGE .................. 15

RANSPORT AND STORAGE ............................................ 16

ESELLING ................................................................. 16

OMBI 200L AND ACCESSORIES ..................................... 17

OMPONENTS OF COMBI 200L ....................................... 18

ISPLAY ................................................................... 19

ISPLAY SYMBOLS ....................................................... 20

YMBOLS FOR CURRENT SHAPES IN MEMORY MENU .............. 20

ARAMETER SYMBOLS .................................................. 21

URRENT SHAPES ........................................................ 22

4 OPERATION ................................................................................... 25

4.1 T

4.2 P

4.3 E

4.4 U

4.5 C

4.6 L

4.7 D

4.8 P

4.9 S

HERAPY SELECTION .................................................... 25

ERFORMING THERAPY .................................................. 28

LECTROTHERAPY ........................................................ 30

LTRASOUND THERAPY ................................................. 38

OMBINATION THERAPY ................................................ 40

ASER THERAPY .......................................................... 41

IAGNOSTIC PROGRAMS ................................................ 43

ROGRAMS ................................................................ 45

YSTEM SETTINGS ....................................................... 47

5 INSPECTIONS AND MAINTENANCE ........................................... 53

5.1 I

5.2 M

NSPECTIONS .............................................................. 53

AINTENANCE ............................................................ 55

6 MALFUNCTIONS, SERVICE AND GUARANTEE ......................... 57

6.1 M

ALFUNCTIONS .......................................................... 57

Combi 200L

6.2 SERVICE ................................................................... 58

6.3 G

6.4 T

UARANTEE ............................................................... 58

ECHNICAL LIFE TIME ................................................... 59

7 TECHNICAL INFORMATION ......................................................... 61

7.1 G

7.2 E

7.3 U

7.4 L

7.5 E

7.6 T

7.7 S

7.8 O

7.9 O

7.10 O

ENERAL .................................................................. 61

LECTROTHERAPY ........................................................ 61

LTRASOUND THERAPY ................................................. 64

ASER THERAPY .......................................................... 65

NVIRONMENTAL CONDITIONS ......................................... 66

RANSPORT AND STORAGE ............................................ 66

TANDARD ACCESSORIES .............................................. 67

PTIONAL ACCESSORIES ELECTROTHERAPY ......................... 68

PTIONAL ACCESSORIES ULTRASOUND THERAPY .................. 69

PTIONAL ACCESSORIES LASER THERAPY ........................... 69

8 APPENDICES ................................................................................. 71

8.1 A

8.2 D

8.3 EMC

8.4 T

8.5 D

GENTS FOR IONTOPHORESIS ......................................... 71

IAGNOSTIC I/T-CURVE ................................................ 72

DIRECTIVE .......................................................... 73

ECHNICAL SAFETY INSPECTION ...................................... 77

ISPOSAL ................................................................. 82

9 REFERENCE ................................................................................... 83

9.1 F

9.2 L

9.3 T

UNCTION OVERVIEW .................................................... 83

ITERATURE ............................................................... 91

ERMINOLOGY............................................................. 91

10 INDEX ............................................................................................. 95

Combi 200L

1SAFETY

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.

Combi 200L

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.

1.2.5 Electrotherapy

• Do not use the equipment simultaneously with high frequency

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 mA However, with iontophoresis treatments, we advise a maximum current density of 0.25 mÂ/cm the MF rectangular current. Exceeding this value can result in skin irritation and burns.

• Always use sterilised gauze with iontophoresis treatments.

1.2.6 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.

Combi 200L

/cm2.

rms

, because of using

Combi 200L

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

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.

1.3 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.

Combi 200L

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.

Combi 200L

2INSTALLATION

2.1 Receipt

1. Check whether the equipment has been damaged during transport.

2. 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.

2.2 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.

3. Connect the device to an outlet with protective earth terminal.

2.3 Performing the functional test

1. Switch the equipment on with the switch at the rear of the equipment.

2. When the equipment is switched on, it automatically performs a test. Check whether the indicator lamps next to and light briefly during the test.

3. If the lamps do not light up: See §6.

2.4 Setting contrast and selecting language

1. Press for 5 seconds. The System setting menu appears. See §4.9.

2. Press next to Contrast, 1

3. If necessary, change the contrast with and .

4. Press next to Language.

5. If necessary, change the language with and .

6. Press to return to the start menu.

key from the top.

Combi 200L

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.

Combi 200L

3DESCRIPTION OF THE EQUIPMENT

3.1 Combi 200L and accessories

1. Combi 200L. See §3.2.

2. Power cord

3. Laser goggles. Optional accessory. See §7.10.

4. Laser probe. Optional accessory. See §7.10.

5. US head

6. Contact gel

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

3.2 Components of Combi 200L

2 3 4 5

6 7

91510

13 14

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

21 22 23 24

18 17 16

292631

30 3227 28

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

3.3 Display

Combi 200L

123 4

10 11

1. Channel

2. Therapy

3. Current shape

4. Title of the screen

5. Program number

6. Parameters with selection knobs

7. Use to go to the next parameters

15:00

set

red+

US+Conv

Pulse time

Pulse form

Min.

Max.

Sweep mode

Treatment

Perceptibe, comfortable

TENS

frequency

time

8. Explanation or recommendation

9. 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.

40 s

100

15:00

3.4 Display symbols

3.4.1 General

Combi 200L

SEQ

Electrotherapy Channel A

Ultrasound therapy Channel B

Combination therapy

Laser therapy Treatment time

Sequential current shapes

A + B

0:00

Channel A and B simultaneously

Treatment completed

3.4.2 Current shape groups

Unidirectional currents 2-pole medium frequency

Diadynamic 4-pole Interferential

TENS currents

NMES currents Diagnostic programs

4-pole interferential with vector

3.5 Symbols for current shapes in memory menu

Medium frequency unidirectional current

Unidirectional rectangular current

Unidirectional triangular current

Conventional TENS Biphasic surge current

Low frequency TENS

Random TENS

Burst TENS

Rectangular surge current

Triangular surge current

Intrapulse interval surge current

2-pole medium frequency surge current

Combi 200L

CP (diadynamic) 2-pole medium frequency

DF (diadynamic) Dipole vector field

LP (diadynamic) Rheobase and chronaxie

MF (diadynamic) Rheobase and AQ

3.6 Parameter symbols

3.6.1 Electrotherapy

Red+ Red-

Sweep mode

Polarity indication Constant Current

Alternating polarity Constant Voltage

Biphasic pulse shape, symmetrical

Biphasic pulse shape, asymmetrical

CHR

mA peak

Volt peak

12s/12s 1s/5s -1s/5s

6s/6s 1s/1s

3.6.2 Ultrasound therapy

10ms

US duty cycle 10% US duty cycle 100%

10% 100%

US duty cycle 20% Set US intensity

20%

US duty cycle 30% Peak US output power

30%

US duty cycle 40%

40%

US duty cycle 50%

50%

W cm

set

Unit of the set US

intensity

3.6.3 Laser therapy

Combi 200L

Set average power

set

Energy per pulse Wear goggles

Monoprobe Clusterprobe

3.7 Current shapes

3.7.1 Unidirectional currents

Rectangular pulse current Triangular pulse current

2-5 current (UltraReiz)

5 ms

2 ms

3.7.2 Diadynamic currents

MF CP

DF LP

3.7.3 Interferential currents

tot

energy

Medium frequency rectangular current

Total administered

2-pole medium frequency

4-pole Interferential

3.7.4 TENS currents

Conventional TENS, asymmetrical

Conventional TENS, alternating asymmetrical

Conventional TENS, symmetrical

4-pole interferential with rotating vector

Conventional TENS, alternating symmetrical

TENS burst

TENS burst, alternating

3.7.5 NMES currents

Combi 200L

Rectangular surge current

Triangular surge current

Medium frequency surge current (2- and 4-pole)

Biphasic surge current

Intrapulse interval surge current

Combi 200L

4OPERATION

4.1 Therapy selection

You can select a therapy in different ways, with the therapy keys or with the parameters in the Start menu:

• Therapy keys: Quickly select a therapy with therapy keys , , and

. See §4.1.1.

• Objectives: Select a therapy on the basis of an objective. See §4.1.2.

• Indication list: Select a therapy on the basis of a medical indication.

See §4.1.3.

• Program number: Select a certain program number or a program

number that you previously saved. See §4.1.4.

• Diagnostic programs: Perform a diagnosis, for example to determine

the rheobase and the chronaxie. See §4.1.5.

• Contra indications: Display an overview with contra indications for the

different therapies. See §4.1.6.

Besides this, you can change the system settings. See §4.9.

4.1.1 Therapy keys

Electrotherapy selection

1. Press : Electrotherapy.

2. Select the current shape group with .

3. Select the current shape with

Ultrasound therapy, direct selection

1. Press : Ultrasound therapy. The Ultrasound screen appears.

Combination therapy, direct selection

1. Press : Combination therapy.

2. Select the current shape with . See §4.5.1.

Laser therapy, direct selection

1. Press : Laser therapy. The Laser therapy screen appears.

Combi 200L

4.1.2 Therapy selection via objectives

1. Press to go to the start menu.

2. Select Objectives.

3. Select Electrotherapy,

Ultrasound therapy or Laser therapy.

4. Select the desired treatment with .

4.1.3 Therapy selection via indication list

1. Press to go to the start menu.

2. Select Indication list.

3. Go to the following indications with or . See §9.1.4.

4. Select the desired indication with .

• ET: Electrotherapy

• US: Ultrasound therapy

• LA: Laser therapy

• CO: Combination therapy

4.1.4 Program number selection

1. Press to go to the start menu.

2. Select Program number.

3. Select the desired program with

or . See §9.1.

4. Press . See §4.8.

Combi 200L

4.1.5 Diagnostic program selection

With the diagnostic programs, you can localise and treat pain points, and look for stress fractures, etc.

1. Press to go to the start menu.

2. Select Diagnostic programs.

3. Select the desired diagnosis with . See §4.7.

4.1.6 Contra indication selection

1. Press to go to the start menu.

2. Select Contra indications.

3. Select the therapy for which you want to see the contra indications.

Combi 200L

4.2 Performing therapy

4.2.1 Set and start therapy

1. Press to go to the start menu.

2. Select the desired menu with until the treatment appears.

3. Select the desired parameters with . You can only change the outlined parameters.

4. Set the Treatment time as follows: Press once on to set the minutes, press twice on to set the seconds.

5. Change the value of the parameter with and . The setting range of the parameter is shown at the bottom of the screen. You can change the parameter as long as the parameter has a black background.

6. Start the therapy:

• Electrotherapy or ultrasound therapy: Rotate intensity knob A or B

to start the treatment and to set the desired intensity. The set intensity is displayed in the screen.

• Laser therapy: See §4.6.1.

4.2.2 Set channels A and B

The Combi 200L has two separated electrotherapy channels A and B. The only restriction is that both are in the CC mode or the CV mode.

The channels A and B can be used independently. You can treat two different indications simultaneously with two different treatments.

1. Press for 5 seconds. The System setting menu appears. See §4.9.

2. If necessary, change the parameter Copy parameters to OFF.

3. The selected channel has a black background. If desired, press to

change the first channel.

4. Select a treatment. See §4.1.

5. Set the parameters for the first channel. See §4.2.1.

6. Press to select the other channel.

7. Select a treatment for the second channel. See §4.1.

8. Set the parameters for the second channel. See §4.2.1.

Both channels are selected simultaneously and automatically in case of:

• 4-pole current shapes

• Combination therapy

Combi 200L

Copy channel

On the second channel, you can set the same parameters for electrotherapy as for the first set channel.

1. Press for 5 seconds. The System setting menu appears. See §4.9.

2. If necessary, change the parameter Copy parameters to ON.

3. Select a treatment. See §4.1.

4. Set the parameters for the first channel. See §4.2.1.

5. Press to select the other channel. The treatment including the

settings are copied to the other channel.

6. If desired you can change the parameters or the treatment of the selected channel.

Clear channel

1. Make sure that the intensity is set to zero.

2. Press to select the channel that you want to clear.

3. Press . The channel is cleared.

4.2.3 Opening the intensity screen

1. Set and start the treatment. See

§4.2.1.

2. Press . The intensity screen appears. The left part of the screen shows channel A. The right part of the screen shows channel B.

3. Press to return to the setting menu.

4.2.4 Temporary interruption of treatment

1. If the other channel has to pause: Select this channel with .

2. Press during the treatment. The treatment time of the selected channel is stopped. Pause appears on the screen. The parameter settings are retained.

3. Press on again to restart the treatment. The intensity now increases gradually to the set level and the treatment time continues again.

4.2.5 Immediately stop treatment

1. Press . All active treatments are stopped immediately. Stop appears on the screen. The parameter settings are retained.

2. Set the intensity of the channel again to continue the treatment.

Combi 200L

4.3 Electrotherapy

4.3.1 Performing electrotherapy with electrodes

1. Select the desired electrotherapy program.

2. Place the electrodes. See page 30: Placing rubber electrodes and page 31: Placing the adhesive electrodes. With some treatments, the Electrode placing parameter refers to the number in the placing diagrams.

3. Rotate intensity knob A or B to start the electrotherapy and to set the desired intensity. See §4.2.1.

4. Check the patient's reaction. Repeat this check regularly during the treatment.

5. The equipment stops the treatment and indicates that the treatment is completed. Remove the electrodes.

Placing rubber electrodes

1. Moisten two EL sponges. Use water with a saline solution to improve the conductivity of the EL sponges.

2. Slide a rubber electrode into each sponge.

3. Place the sponges on the part of the body that must be treated.

4. Fasten the sponges to the part of the body with the elastic fixation straps.

5. Connect the rubber electrode with the red connector to the red connector of the two-ply electrode cable.

6. Connect the rubber electrode with the black connector to the black connector of the two-ply electrode cable.

7. Connect the two-ply cable to connector or of the Combi 200L.

+ 70 hidden pages