GymnaUniphy Myo 200 User manual

Myo 200
User Manual
Pasweg 6A
B-3740 Bilzen
Tel.: (+32) (0) 89/510.510
Fax: (+32) (0) 89/510.511
www.gymna-uniphy.com
E-mail: [e-mail]
Your dealer:
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© 2006, 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 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 [e-mail]
Website www.gymna-uniphy.com
Version 1.1
November 2008
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Abbreviations
Symbols on the equipment
Symbols in the manual
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
Read the manual
Manufacturer
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 .................................................................................. 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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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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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.
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1.2.2 Electrical safety
1.2.3 Prevention of explosion
1.2.4 Electro Magnetic Compatibility
•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.
•Do not use the equipment in an area where combustible
gases or vapours are present.
•Switch off the equipment when it is not used.
•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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1.2.5 Electrotherapy
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.
•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 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.
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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, 1st key from the top.
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.
A B
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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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Myo 200
3DESCRIPTION OF THE EQUIPMENT
3.1 Myo 200 and standard accessories
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 PC-
software
11. USB connection cable
12. Reference cable
13. Two-ply EMG electrode cable (2
pieces) and two-ply EMG-
incontinence electrode cable
13
12
11
10
3
4
5
2
9 8
7
1
6
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3.2 Components of Myo 200
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
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
A
AB
B
!
A
P
B
REF
2
3
4
5
6
7
8139101112
1
16
15
14
25 26 27 28
29 30
31
1918
21
2220 23 24
17
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Myo 200
3.3 Display
3.3.1 Display for electrotherapy
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
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
Pulse time 40 s
US+Conv.TENS 34
Pulse form
Min. frequency
frequency
Max.
80
100
Hz
Hz
Sweep mode
Treatment time 15:00
15:00
red+
0CV
set
00
00
.
.
Perceptibe, comfortable
123 4 5
6
7
8
9
10
12
11
13
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3.3.2 Display for re-education
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)
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
123 7
10
16
17
18
20
19
21
46 985
1415 12 1113
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Myo 200
3.4 Display symbols
3.4.1 General
3.4.2 Current shape groups
3.5 Symbols for current shapes in memory menu
Electrotherapy
stimulation Channel A
Feedback Channel B
Electrotherapy
stimulation and feedback
Channel A and B
simultaneously
Treatment time Channel P
Treatment completed ET: Sequential current
shapes
FB: Number of
sequences
Unidirectional currents 2-pole medium frequency
Diadynamic 4-pole Interferential
TENS currents 4-pole interferential with
vector
NMES currents Diagnostic programs
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
A
B
A + B
P
0:00 SEQ
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3.6 Parameter
3.6.1 Electrotherapy
Sweep mode
Random TENS 2-pole medium frequency
surge current
CP (diadynamic) 2-pole medium frequency
DF (diadynamic) 4-pole interferential with
rotating vector
LP (diadynamic) Rheobase and chronaxie
MF (diadynamic) Rheobase and AQ
Polarity indication Constant Current
Alternating polarity Constant Voltage
Biphasic pulse shape,
symmetrical mA peak
Biphasic pulse shape,
asymmetrical Volt peak (Vpk)
12s/12s 1s/5s -1s/5s
6s/6s 1s/1s
CP
DF
LP CHR
MF AQ
Red+
Red- CC
+-CV
mA
V
12
12
55
11
6
6
1
1
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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
Zoom function
Feedback channel A Phase time menu
Feedback channel A
and B Myo settings menu
Feedback channel A
and P (pressure) Expert menu
Feedback P Capture target menu
Start Electrotherapy
parameters menu
Maximum capture target
method Step size target change
Mean capture target
method Adjust target channel A
Minimum capture target
method Adjust target channel B
Time for the automatic
capture target Adjust target channel P
Manual capture target
method
Zoom channel A Zoom channel P
Zoom channel B
A
AB
AP
P
A
B
sP
AP
B
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State symbols
3.7 Current shapes
3.7.1 Unidirectional currents
3.7.2 Diadynamic currents
3.7.3 Interferential currents
3.7.4 TENS currents
Stimulation phase Capture target
Rest phase Stimulation assessment
Feedback phase Warning no reference
electrode
Rectangular pulse current Triangular pulse current
2-5 current (UltraReiz) Medium frequency
rectangular current
MF CP
DF LP
2-pole medium frequency 4-pole interferential with
rotating vector
4-pole Interferential
Conventional TENS,
asymmetrical
Conventional TENS,
alternating symmetrical
Conventional TENS,
alternating asymmetrical TENS burst
Conventional TENS,
symmetrical TENS burst, alternating
z
z
z
REF
2 ms 5 ms
MF DF
MF DF
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