GymnaUniphy Myo 200 User manual

User Manual

Myo 200

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.

Myo 200

User Manual Myo 200

Device for electrotherapy stimulation and feedback

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 1.1 November 2008

Myo 200

Abbreviations

AQ Accomodation Quotient CC Constant Current CP Courte Période CV Constant Voltage DF Diphasé Fixe EL Electrode EMC Electromagnetic Compatibility EMG Electromyography ESD Electrostatic Discharge ET Electrotherapy FB Feedback HAC Hospital Antiseptic Concentrate 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 P Pressure TENS Transcutaneous Electrical Nerve Stimulation VAS Visual Analogue Scale

Symbols on the equipment

Read the manual

Manufacturer

Symbols in the manual

Warning or important information.

Myo 200

TABLE OF CONTENTS

1 SAFETY ............................................................................................ 7

1.1 P

1.2 S

1.3 M

1.4 L

2 INSTALLATION .............................................................................. 11

2.1 R

2.2 P

2.3 P

2.4 S

2.5 T

2.6 R

3 DESCRIPTION OF THE EQUIPMENT ............................................ 13

3.1 M

3.2 C

3.3 D

3.4 D

3.5 S

3.6 P

3.7 C

URPOSE .................................................................................. 7

AFETY INSTRUCTIONS .............................................................. 7

EDICAL DEVICES DIRECTIVE .................................................... 9

IABILITY .................................................................................. 9

ECEIPT .................................................................................. 11

LACING AND CONNECTION .................................................... 11

ERFORMING THE FUNCTIONAL TEST ........................................ 11

ETTING CONTRAST AND SELECTING LANGUAGE ...................... 11

RANSPORT AND STORAGE ..................................................... 12

ESELLING ............................................................................. 12

YO 200 AND STANDARD ACCESSORIES .................................. 13

OMPONENTS OF MYO 200 .................................................... 14

ISPLAY ................................................................................. 15

ISPLAY SYMBOLS .................................................................. 17

YMBOLS FOR CURRENT SHAPES IN MEMORY MENU ................. 17

ARAMETER ............................................................................ 18

URRENT SHAPES ................................................................... 20

4 OPERATION ................................................................................... 23

4.1 T

4.2 P

4.3 E

4.4 F

4.5 E

4.6 D

4.7 P

4.8 S

HERAPY SELECTION ............................................................... 23

ERFORMING THERAPY ............................................................ 26

LECTROTHERAPY ................................................................... 27

EEDBACK .............................................................................. 37

LECTROTHERAPY STIMULATION IN COMBINATION WITH

FEEDBACK ............................................................................... 44

IAGNOSTIC PROGRAMS ......................................................... 45

ROGRAMS ............................................................................. 47

YSTEM SETTINGS .................................................................. 50

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

5.1 I

5.2 M

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

AINTENANCE ........................................................................ 54

Myo 200

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

6.1 M

6.2 S

6.3 G

6.4 T

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

ERVICE ................................................................................. 58

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

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

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

7.1 G

7.2 E

7.3 F

7.4 E

7.5 T

7.6 S

7.7 O

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

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

EEDBACK .............................................................................. 64

NVIRONMENTAL CONDITIONS ................................................. 64

RANSPORT AND STORAGE ..................................................... 64

TANDARD ACCESSORIES ........................................................ 65

PTIONAL ACCESSORIES ......................................................... 66

8 APPENDICES ................................................................................. 69

8.1 A

8.2 D

8.3 EMC

8.4 T

8.5 D

GENTS FOR IONTOPHORESIS .................................................. 69

IAGNOSTIC I/T-CURVE ........................................................... 70

DIRECTIVE ...................................................................... 71

ECHNICAL SAFETY INSPECTION ............................................... 76

ISPOSAL ............................................................................... 80

9 REFERENCE ................................................................................... 81

9.1 F

9.2 L

9.3 T

UNCTION OVERVIEW ............................................................... 81

ITERATURE ............................................................................ 87

ERMINOLOGY ......................................................................... 87

10 INDEX ............................................................................................. 91

Myo 200

1SAFETY

1.1 Purpose

The Myo 200 is intended solely for medical applications. You can use the Myo 200 for electrotherapy and re-education. For re-education the feedback signal is measured, if chosen in combination with an electrotherapy stimulation. 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 device 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 §5.1.1.

• 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.

Myo 200

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.

• Because the Myo200 is intended to measure extreme small

potentials, its immunity level for electromagnetic radiation is lower then 3V/m. See §8.3.1 for detailed information.

• Only use the accompanying accessories that are supplied by

GymnaUniphy. See §7.6 and §7.7. Other accessories can lead to an increased emission or a reduced immunity.

Myo 200

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.

• Application of electrodes near the thorax may increase the risk

of cardiac fibrillation.

• Check the electrode cables, the electrodes and the probes 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.

/cm2.

rms

, because of using

• Always use sterilised gauze with iontophoresis treatments.

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. The device contains no human or animal tissue, no medical substances, and no blood or blood products from human or animal origin.

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.

Myo 200

2INSTALLATION

2.1 Receipt

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

2. Check whether the accessories are intact and complete. See §7.6 and

§7.7.

• 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 device 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 §4.8.

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 next to Mains frequency.

7. If necessary, change the setting with and to the local mains frequency.

8. Press to return to the start menu.

key from the top.

Myo 200

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 and some of the accessories have a unique serial number. Provide the dealer with the name and address of the new owner.

Myo 200

3DESCRIPTION OF THE EQUIPMENT

3.1 Myo 200 and standard accessories

9 8

1. Myo 200. See §3.2.

2. Power cord

3. VAS score card

4. Vaginal probe ‘Novatys’

5. Vaginal pressure probe

6. Vaginal pressure pipe

7. Test plug

8. Adhensive electrodes (4 pieces)

9. Adhensive electrodes round (4 pieces)

10. CD-ROM with Myo 200 PCsoftware

11. USB connection cable

12. Reference cable

13. Two-ply EMG electrode cable (2 pieces) and two-ply EMGincontinence electrode cable

Myo 200

3.2 Components of Myo 200

2 3 4

5 6

8139101112

1. Display. See §3.3.1.

2. Electrotherapy stimulation

3. Feedback

4. Electrotherapy stimulation and feedback

5. Memory

6. Start menu

7. Channel selection: A or B

8. Stop

9. Intensity of channel A

10. Pause

11. Return to previous menu

12. Intensity of channel B

13. Enter

14. Indication: Read manual

15. Down

16. Up

17. Select parameter or menu

REF

1918

2220 23 24

25 26 27 28

16 15 14

29 30

18. Connector for pressure feedback, channel P

19. Indicator lamp for channel A

20. Connector for electrode, channel A

21. Indication: Type BF applied part

22. Indicator lamp for channel B

23. Connector for electrode, channel B

24. Connector for reference electrode

25. On/off switch

26. Connection to mains supply

27. Type plate

28. Ventilation opening

29. Fuse holder

30. USB connector

31. Speaker grill

Myo 200

3.3 Display

3.3.1 Display for electrotherapy

123 4

10 11

1. Channel

2. Electrotherapy

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. See

§4.3.6.

10. Remaining treatment time

11. Polarity

12. Set intensity

13. Screen for channel B

40 s

100

15:00

Myo 200

3.3.2 Display for re-education

123 7

19 20

1. Channel

2. Therapy (ET, FB or ET-FB)

3. Current shape

4. Bar graph of channel A

5. Target value of channel A

6. Remaining phase time (in seconds)

7. Remaining phase time (diagram)

8. Target value of channel P (B)

9. Bar graph of channel P (B)

10. Settings with selection knobs

11. Feedback value of channel P (B)

985

1415 12 1113

12. Phase symbol

13. Warning no reference electrode

14. Resolution, value of one bar graph segment

15. Zoom function active

16. Feedback value of channel A

17. Screen for channel A.

18. Remaining number of sequences or remaining treatment time

19. Polarity

20. Set intensity

21. Screen for channel B

3.4 Display symbols

3.4.1 General

Myo 200

Electrotherapy stimulation

Feedback Channel B

Electrotherapy stimulation and feedback

Treatment time Channel P

Treatment completed ET:

0:00

3.4.2 Current shape groups

Unidirectional currents 2-pole medium frequency

Diadynamic 4-pole Interferential

TENS currents

NMES currents Diagnostic programs

A + B

SEQ

Channel A

Channel A and B simultaneously

Sequential current shapes

Number of

FB:

sequences

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

Burst TENS

Rectangular surge current

Triangular surge current

Intrapulse interval surge current

Myo 200

Random TENS

CP (diadynamic) 2-pole medium frequency

DF (diadynamic)

LP (diadynamic) Rheobase and chronaxie

MF (diadynamic) Rheobase and AQ

3.6 Parameter

3.6.1 Electrotherapy

Red+ Red-

Polarity indication Constant Current

Alternating polarity Constant Voltage

Biphasic pulse shape, symmetrical

Biphasic pulse shape, asymmetrical

CHR

2-pole medium frequency surge current

4-pole interferential with rotating vector

mA peak

Volt peak (V

)

Sweep mode

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

6s/6s 1s/1s

Myo 200

3.6.2 re-education

To maintain the overview on the re-education display, the settings symbols disappear after a while. The settings symbols appear again by pressing on a random .

Capture target

Feedback channel A Phase time menu

Feedback channel A

and B Feedback channel A

and P (pressure)

Feedback P Capture target menu

Start

Maximum capture target method

Mean capture target method

Minimum capture target method

Time for the automatic

capture target Manual capture target

method

Myo settings menu

Expert menu

Electrotherapy parameters menu

Step size target change

Adjust target channel A

Adjust target channel B

Adjust target channel P

Zoom function

Zoom channel A Zoom channel P

Zoom channel B

State symbols

Stimulation phase Capture target

Rest phase Stimulation assessment

Myo 200

Feedback phase

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

2-pole medium frequency

4-pole Interferential

REF

Warning no reference electrode

Medium frequency rectangular current

4-pole interferential with rotating vector

3.7.4 TENS currents

Conventional TENS, asymmetrical

Conventional TENS, alternating asymmetrical

Conventional TENS, symmetrical

Conventional TENS, alternating symmetrical

TENS burst

TENS burst, alternating

3.7.5 NMES currents

Myo 200

Rectangular surge current

Triangular surge current

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

Biphasic surge current

Intrapulse interval surge current

Myo 200

4OPERATION

4.1 Therapy selection

You can select a therapy in different ways, with the therapy key 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

electrotherapy. See §4.1.6.

Besides this, you can change the system settings. See §4.8.

4.1.1 Therapy keys

Electrotherapy selection

1. Press : Electrotherapy.

2. Select the current shape group with .

3. Select the current shape with

Myo 200

Feedback selection

1. Press : Feedback. The Feedback screen appears.

Electrotherapy in combination with feedback selection

1. Press : Electrotherapy and feedback.

2. Select the current shape with

4.1.2 Therapy selection via objectives

1. Press to go to the start menu.

2. Select Objectives.

3. Select Electrotherapy, Pelvic

re-education or Muscle reeducation.

4. Select the desired treatment with .

Myo 200

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

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 §4.7.

4.1.5 Diagnostic program selection

With the diagnostic programs, you can localise and treat pain points, etc.

1. Press to go to the start menu.

2. Select Diagnostic programs.

3. Select the desired diagnosis with . See §4.6.

Myo 200

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.

4.2 Performing therapy

4.2.1 Channel settings

The Myo 200 has the possibility to select a therapy individual or in combination. The following channel settings are possible.

Channel A Channel B Channel P

ET - - §4.3.1 and §4.3.2

-ET-§4.3.1 and §4.3.2 ET ET - §4.3.1, §4.3.2 and §4.3.5 FB - - §4.4.1

- - FB (pressure) §4.4.2 FB FB - §4.4.1 and §4.4.3 FB - FB (pressure) §4.4.1, §4.4.2 and §4.4.3 FB ET - §4.4.1, §4.3.1 and §4.3.2 FB ET FB (pressure) §4.4.1, §4.3.1, §4.3.2,

§4.4.2 and §4.4.3 ET+FB - - §4.5.1 ET+FB FB - §4.5.1, §4.4.1, §4.4.3 and

ET+FB - FB (pressure) §4.5.1, §4.4.2, §4.4.3 and

ET+FB ET+FB - §4.5.1 and §4.5.3

See

§4.5.3

Myo 200

Channel A Channel B Channel P

See

ET+FB ET - §4.5.1, §4.3.1, §4.3.2 and

§4.5.3

ET+FB ET FB (pressure) §4.5.1, §4.3.1, §4.3.2,

§4.5.3, §4.4.2 and §4.4.3

4.2.2 Set parameters

1. Select the desired parameters with after the therapy is selected. See §4.1. You can only change the outlined parameters. In the reeducation display the small outlined parameters disappear during treatment after a while to keep the overview on the screen. Press a random first to see the parameters.

2. 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.

4.2.3 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.

4.2.4 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.

4.3 Electrotherapy

4.3.1 Performing electrotherapy with electrodes

1. Select the desired electrotherapy program. See §4.1.

2. Place the electrodes. See page 28: Placing rubber electrodes and page

28: Placing 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 §4.1.2.

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.

Myo 200

Placing adhesive electrodes

Do not use adhesive electrodes with currents that have a galvanic component, such as galvanic, diadynamic, MF rectangular, pulsed rectangular and triangular currents. These currents can cause skin etching.

1. If possible, disinfect the parts of the body where the adhesive electrodes are to be placed.

2. Place the electrodes on the part of the body that must be treated.

3. Connect the connectors of the adhesive electrodes to the two-ply EMG electrode cable (black and red connector).

4. Connect the two-ply EMG electrode cable to connector or of the Myo 200.

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 red connector of the rubber electrode to the red connector of the two-ply (EMG) electrode cable (4 mm).

6. Connect the black connector of the rubber electrode to the black connector of the two-ply (EMG) electrode cable (4 mm).

7. Connect the two-ply (EMG) electrode cable to connector or of

the Myo 200.

Myo 200

4.3.2 Performing electrotherapy with a probe

• Considering the hygiene and the very personal and intimate

character of these treatments, a probe may only be used for one patient.

• Never disinfect the probes in an autoclave. The probes can be

damaged by the extreme temperature.

1. Clean the probe carefully with soap and water. See §5.2.4.

2. Select the desired electrotherapy program.

3. Make sure the intensity is zero.

4. Place the probe. See page 29: Placing a vaginal or an anal probe and page 30: Placing a rectal probe.

5. Rotate intensity knob A or B to start the treatment and to set the desired intensity.

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

7. The equipment stops the treatment and indicates that the treatment is completed.

8. Make sure the intensity is zero.

9. Remove the probe.

10. Clean the probe. See §5.2.4.

Placing a vaginal or an anal probe

1. Connect the probe to the two-ply EMG-incontinence electrode cable (white connectors).

2. Connect the two-ply EMGincontinence electrode cable to connector or of the Myo

200. The probe is immediately detected by the equipment. To prevent unpleasant stimulations, you can only set alternating currents with a Constant Voltage (CV) setting, such as TENS, NMES, and 2-pole interferential currents.

3. Apply, if necessary, an antiseptic lubricant to the probe.

4. Place the probe.

+ 66 hidden pages

GymnaUniphy Myo 200 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual