Myo 200 User Manual Ver 1.1 Nov 2008

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Myo 200

User Manual Myo 200 Device for electrotherapy stimulation and feedback 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 November 2008

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Myo 200

Abbreviations AQ CC CP CV DF EL EMC EMG ESD ET FB HAC LP MF MTP NMES P TENS VAS

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

Symbols on the equipment

Read the manual Manufacturer

Symbols in the manual

Warning or important information.

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Myo 200

TABLE OF CONTENTS 1

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

2

INSTALLATION ... 11 2.1 RECEIPT ... 11 2.2 PLACING AND CONNECTION ... 11 2.3 PERFORMING THE FUNCTIONAL TEST ... 11 2.4 SETTING CONTRAST AND SELECTING LANGUAGE ... 11 2.5 TRANSPORT AND STORAGE ... 12 2.6 RESELLING ... 12

3

DESCRIPTION OF THE EQUIPMENT ... 13 3.1 MYO 200 AND STANDARD ACCESSORIES ... 13 3.2 COMPONENTS OF MYO 200 ... 14 3.3 DISPLAY ... 15 3.4 DISPLAY SYMBOLS ... 17 3.5 SYMBOLS FOR CURRENT SHAPES IN MEMORY MENU ... 17 3.6 PARAMETER ... 18 3.7 CURRENT SHAPES ... 20

4

OPERATION ... 23 4.1 THERAPY SELECTION ... 23 4.2 PERFORMING THERAPY ... 26 4.3 ELECTROTHERAPY ... 27 4.4 FEEDBACK ... 37 4.5 ELECTROTHERAPY STIMULATION IN COMBINATION WITH FEEDBACK ... 44 4.6 DIAGNOSTIC PROGRAMS ... 45 4.7 PROGRAMS ... 47 4.8 SYSTEM SETTINGS ... 50

5

INSPECTIONS AND MAINTENANCE ... 53 5.1 INSPECTIONS ... 53 5.2 MAINTENANCE ... 54

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Myo 200 6

MALFUNCTIONS, SERVICE AND GUARANTEE ... 57 6.1 MALFUNCTIONS ... 57 6.2 SERVICE ... 58 6.3 GUARANTEE ... 58 6.4 TECHNICAL LIFE TIME ... 59

7

TECHNICAL INFORMATION ... 61 7.1 GENERAL ... 61 7.2 ELECTROTHERAPY ... 61 7.3 FEEDBACK ... 64 7.4 ENVIRONMENTAL CONDITIONS ... 64 7.5 TRANSPORT AND STORAGE ... 64 7.6 STANDARD ACCESSORIES ... 65 7.7 OPTIONAL ACCESSORIES ... 66

8

APPENDICES ... 69 8.1 AGENTS FOR IONTOPHORESIS ... 69 8.2 DIAGNOSTIC I/T-CURVE ... 70 8.3 EMC DIRECTIVE ... 71 8.4 TECHNICAL SAFETY INSPECTION ... 76 8.5 DISPOSAL ... 80

9

REFERENCE ... 81 9.1 FUNCTION OVERVIEW ... 81 9.2 LITERATURE ... 87 9.3 TERMINOLOGY ... 87

10

INDEX ... 91

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Myo 200

1

SAFETY

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.

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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.

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Myo 200

1.2.5

Electrotherapy

• Do not use the equipment simultaneously with high frequency •

• • •

• 1.3

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 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.

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.

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Myo 200

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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 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.

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

3.

2.3 1. 2.

3.

2.4 1. 2. 3. 4. 5. 6. 7. 8.

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 §4.8. 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 next to Mains frequency. If necessary, change the setting with and to the local mains frequency. 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 and some of the 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

Myo 200 and standard accessories 1

13

2

12

3

11

4

10 7

5 9

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

8

6

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. See §3.2. Power cord VAS score card Vaginal probe ‘Novatys’ Vaginal pressure probe Vaginal pressure pipe Test plug Adhensive electrodes (4 pieces)

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Myo 200

3.2

Components of Myo 200 21 1 A

B

REF

P

2 3 4

17

5 6 7

A

A

16 15 14

B

!

B

8

18 19 20 22 23 24 25 26 27 28

29

30

9 10 11 12 13 31

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

1. 2. 3. 4.

Display. See §3.3.1. Electrotherapy stimulation Feedback 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

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3.3

Display

3.3.1

Display for electrotherapy

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

. set00

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. See §4.3.6. 10. Remaining treatment time 11. Polarity 12. Set intensity 13. Screen for channel B

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

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3.3.2

Display for re-education

1

17

2

3

4 5 6 7

89

18 19 20

10

21

16 15 14 13 12 11 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

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

Channel Therapy (ET, FB or ET-FB) Current shape Bar graph of channel A Target value of channel A 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)

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Myo 200

3.4

Display symbols

3.4.1

General Electrotherapy stimulation

A

Channel A

Feedback

B

Channel B

Electrotherapy stimulation and feedback

A+B

Treatment time

P

0:00 Treatment completed

SEQ

3.4.2

3.5

Channel A and B simultaneously Channel P ET: Sequential current shapes Number of FB: sequences

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 17

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Myo 200

Random TENS

2-pole medium frequency surge current

CP

CP (diadynamic)

2-pole medium frequency

DF

DF (diadynamic)

4-pole interferential with rotating vector

LP

LP (diadynamic)

MF

MF (diadynamic)

3.6

Parameter

3.6.1

Electrotherapy

CHR AQ

Rheobase and chronaxie Rheobase and AQ

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 (Vpk)

+

Sweep mode 12

12s/12s

6

6s/6s

1

1 5

12

1

6

18

5

1s/5s -1s/5s

1

1s/1s

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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 .

A

Feedback channel A

Phase time menu

Feedback channel A

A

B and B

A

P and P (pressure)

Expert menu

P

Feedback P

Capture target menu

Start

Electrotherapy parameters menu

Myo settings menu

Feedback channel A

Capture target Maximum capture target method

Step size target change

Mean capture target method

A Adjust target channel A

Minimum capture target method

B Adjust target channel B

Time for the automatic

P Adjust target channel P

s capture target

Manual capture target method Zoom function

A Zoom channel A

P Zoom channel P

B Zoom channel B

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Myo 200 State symbols

z zz

Stimulation phase

Capture target

Rest phase

Stimulation assessment

REF

Feedback phase

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

3.7.3

Warning no reference electrode

LP

Interferential currents 4-pole interferential with rotating vector

2-pole medium frequency 4-pole Interferential

3.7.4

TENS currents Conventional TENS, asymmetrical

Conventional TENS, alternating symmetrical

Conventional TENS, alternating asymmetrical

TENS burst

Conventional TENS, symmetrical

TENS burst, alternating

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Myo 200

3.7.5

NMES currents Rectangular surge current

Biphasic surge current

Triangular surge current

Intrapulse interval surge current

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

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