GymnaUniphy Combi 500 User manual
COMBI 500
ELECTROTHERAPY ULTRASOUND LASER UNIT
OPERATING INSTRUCTIONS
Your supplier is:
The COMBI 500 is made in Belgium by GymnaUniphy
At the beginning of these Operating Instructions you will find an exploded view of the
Combi 500 and its accessories.
The numbers on the drawings correspond to the numbers
in these Operating Instructions.
We advise you to go through these Operating Instructions,
while you get familiar with your new Combi 500.
2 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
1 TABLE OF CONTENTS
1 TABLE OF CONTENTS........................................................................................ 3
2 SAFETY REGULATIONS.................................................................................... 10
2.1 Electrical safety.................................................................................................. 10
2.2 Explosion prevention......................................................................................... 10
2.3 Operational safety.............................................................................................. 10
2.3.1 Operational safety - Generalities ......................................................................... 10
2.3.2 Operational safety – while using lasers ............................................................... 11
2.4 Transportation and storage............................................................................... 11
2.5 Use of the Combi 500......................................................................................... 11
2.6 Medical Device Directive ................................................................................... 12
2.7 Technical Control............................................................................................... 12
2.7.1 Inspection interval................................................................................................ 12
2.7.2 Inspection results................................................................................................. 13
3 INSTALLATION................................................................................................... 14
3.1 Introduction ........................................................................................................ 14
3.2 On receipt of your Combi 500 unit.................................................................... 14
3.3 Connecting and starting.................................................................................... 14
3.4 Language selection............................................................................................ 15
3.5 Hooking up accessories on the connectors.................................................... 15
3.5.1 Electrotherapy-connectors
3.5.1.1 Vaginal, anal or rectal stimulating probes..................................................... 15
3.5.2 The ultrasound connectors
20 21
........................................................................... 15
22 23
.......................................................................... 16
3.5.3 The laser-connector 24......................................................................................... 16
3.6 Functional test.................................................................................................... 17
3.7 New owner .......................................................................................................... 17
3.8 Liquidation.......................................................................................................... 17
4 CONTROLS......................................................................................................... 18
4.1 Introduction ........................................................................................................ 18
COMBI 500 – Operating instructions - version 1.1 – 12/2001
3
4.2 Controls, connectors, standard accessories ................................................... 18
5 SELECTION OF A TREATMENT ........................................................................20
5.1 Different therapeutic possibilities - generalities..............................................20
5.2 Start menu............................................................................................................20
5.3 Therapeutic keys.................................................................................................21
5.4 Selection of a treatment method by means of OBJECTIVES..........................21
5.4.1 Objective Electrotherapy, example of a selection.................................................22
5.4.2 Objective Laser therapy, example of a selection..................................................24
5.4.3 Objective ET Iontophoresis or Ultrasound therapy, example of a selection.........27
5.5 Selecting a treatment method through INDICATION LIST...............................27
5.6 Selecting a treatment method through a PROGRAM-NUMBER......................29
5.7 Selecting programs for DIAGNOSTICS.............................................................30
5.8 Direct selection of a CURRENT SHAPE ............................................................32
5.9 Direct selection of the ULTRASOUND THERAPY ............................................33
5.10 Direct selection of the COMBINED THERAPY..................................................33
5.11 Direct selection of the LASER THERAPY .........................................................35
5.12 Selection of a treatment out of the MEMORY...................................................35
6 GENERAL OPERATING INSTRUCTIONS..........................................................36
6.1 Introduction .........................................................................................................36
6.2 Electrotherapy – Display ....................................................................................36
6.3 Ultrasound therapy – Display.............................................................................37
6.4 Laser therapy – Display......................................................................................37
6.5 Combined therapy – Display..............................................................................38
6.6 Green keys – select menu or select parameter / modify.................................39
6.7 The UP- and DOWN-keys and ..................................................................40
6.7.1 Browsing with the keys and .......................................................................40
6.7.2 Modifying parameters with the help of the keys and ..................................41
6.8 Return key .....................................................................................................41
6.9 Help key ? - Request detailed explanation....................................................41
4 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
6.10 Channel selection key A or B ...................................................................... 43
6.11 Enter key - call intensity display ................................................................ 44
6.12 Intensity buttons and - content of the channel windows ............. 45
6.12.1 Electrotherapy 4-poles – adjust intensity......................................................... 45
6.12.2 Bursts – adjust intensity.................................................................................... 45
6.12.3 Alternating channels - adjust intensity.............................................................. 46
6.12.4 Iontophoresis – adjust intensity ........................................................................ 46
6.12.5 Sequential programs – adjust intensity............................................................. 47
6.12.6 Ultrasound therapy - adjust intensity ................................................................ 47
6.12.6.1 Contact-control – graphical representation...............................................47
6.12.6.2 Multi-frequent Ultrasound head in the case of a US therapy.................... 48
6.12.7 Combined therapy - adjust intensity ................................................................. 48
6.12.7.1 Multi-frequent Ultrasound head used during the combined therapy......... 49
6.12.8 Laser therapy - total energy dissipated ............................................................ 49
6.12.8.1 Laser probe............................................................................................... 50
6.12.8.2 Testing the Laser probe –during the treatment......................................... 50
6.12.9 Intensity - end of treatment, content of the channel windows...........................51
6.13 Pause key - interrupt the treatment temporarily....................................... 51
6.14 Stop key - interrupt the treatment immediately......................................... 52
6.15 Starting up the unit out of STAND-BY.............................................................. 53
7 SOME PARTICULAR THERAPEUTICAL AND PARAMETER POSSIBILITIES 54
7.1 Introduction ........................................................................................................ 54
7.2 CONTRA-INDICATIONS on the display ............................................................ 54
7.3 The option INFORMATION................................................................................. 55
7.4 Electrode placement, ultrasound heads and laser probes............................. 55
7.5 Iontophoresis...................................................................................................... 58
7.6 Sequential current shapes................................................................................. 61
7.6.1 Sequential current shapes – advantages............................................................ 61
7.6.2 Sequential current shapes – intensity.................................................................. 61
7.6.3 Sequential current shapes – selection................................................................. 61
7.7 Constant Current - Constant Voltage............................................................... 63
7.7.1 Generalities..........................................................................................................63
7.7.2 Pelvic re-education .............................................................................................. 64
7.8 Setting different current or therapy forms per channel (A + B).................... 64
7.9 Both channels (A + B) – automatic copying of the same current shape ...... 65
7.10 Modify Standard programs................................................................................ 66
COMBI 500 – Operating instructions - version 1.1 – 12/2001
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7.11 Expert Mode & Expert Times..............................................................................67
7.11.1 NMES-currents – special mode........................................................................67
7.11.1.1 Active rest (REST).....................................................................................67
7.11.1.2 Use of the second ON period (ON2) .........................................................68
7.11.1.3 Frequency variation ( )...................................................................68
7.12 Alternating channels ( )................................................................................68
7.13 NMES-currents and 4-pole interferential currents - graphical representation
of the current
.......................................................................................................68
8 DIAGNOSTIC PROGRAMS.................................................................................70
8.1 Introduction .........................................................................................................70
8.2 Determine Rheobase and Chronaxie.................................................................70
8.3 Determine Rheobase and Accommodation Quotient......................................72
8.4 Record S-D curve................................................................................................73
8.4.1 S-D curve – Adjust intensity..................................................................................74
8.5 Storing data in the memory ................................................................................75
8.6 Pain points...........................................................................................................75
9 TREATMENT MEMORY ......................................................................................76
9.1 Introduction .........................................................................................................76
9.2 Save Therapy program / Diagnostic program ..................................................76
9.3 Open saved programs ........................................................................................78
9.3.1 Opening through a list of names...........................................................................79
9.3.2 Opening through a number...................................................................................80
9.4 Erasing data.........................................................................................................81
9.4.1 Erasing through list of names...............................................................................81
10 SYSTEM SETTINGS AND BASIC SETTINGS....................................................83
10.1 Introduction .........................................................................................................83
10.2 Language selection.............................................................................................83
10.3 Sound...................................................................................................................83
10.3.1 Acoustic signal at the end of treatment .............................................................83
10.3.2 Acoustic signal when pressing a key.................................................................84
10.3.3 Sound during ET Stimulation.............................................................................84
10.3.4 Sound volume ...................................................................................................84
10.3.5 Beep ET (Electrotherapy) contact .....................................................................84
10.3.6 Beep US (Ultrasound) contact-control...............................................................84
10.3.7 Beep laser power ..............................................................................................84
6 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
10.4 ‘Stand-by’ time.................................................................................................... 84
10.5 Starting window text .......................................................................................... 85
10.6 Copying parameters into another channel ...................................................... 85
10.7 System information............................................................................................ 86
10.8 Testing Electrode cables and electrodes......................................................... 86
10.8.1 Testing Electrode cables .................................................................................. 86
10.8.2 Testing Electrodes............................................................................................ 87
10.9 Testing Laser probes......................................................................................... 87
10.10 Error history........................................................................................................ 88
10.11 Working hours.................................................................................................... 89
10.12 Reset working hours.......................................................................................... 89
10.13 Restoring standard programs........................................................................... 90
11 INDICATIONS AND CONTRA-INDICATIONS.................................................... 91
11.1 Electrotherapy - indications.............................................................................. 91
11.2 Ultrasound therapy - indications ...................................................................... 94
11.3 Combined therapy - indications........................................................................ 94
11.4 Laser therapy - indications................................................................................ 94
11.5 Electrotherapy - contra-indications.................................................................. 95
11.5.1 Electrotherapy monophasic pulses / iontophoresis - contra-indications........... 95
11.5.2 Electrotherapy biphasic pulses - contra-indications ......................................... 95
11.6 Ultrasound therapy - contra-indications.......................................................... 96
11.7 Combined therapy - contra-indications............................................................ 96
11.8 Laser therapy - contra-indications.................................................................... 97
12 INTERFERENCES, WARRANTY, LIABILITY, SERVICE ................................... 98
12.1 Interferences....................................................................................................... 98
12.2 Warranty and Liability........................................................................................ 98
12.2.1 Guarantee conditions ....................................................................................... 98
12.2.2 Liability.............................................................................................................. 99
12.3 Service................................................................................................................. 99
13 MAINTENANCE AND CLEANING.................................................................... 101
COMBI 500 – Operating instructions - version 1.1 – 12/2001
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13.1 Cleaning the device...........................................................................................101
13.2 Cleaning electrodes and sponges...................................................................101
13.3 Cleaning the incontinence treatment probes.................................................102
13.4 Cleaning the Ultrasound head .........................................................................102
13.5 Cleaning Laser probes......................................................................................103
14 SPECIFICATIONS..............................................................................................104
14.1 Rectified currents..............................................................................................104
14.2 Diadynamic currents.........................................................................................104
14.3 TENS currents ...................................................................................................105
14.4 NMES currents...................................................................................................105
14.5 Interferential currents.......................................................................................107
14.6 Diagnostic programs ........................................................................................108
14.7 Generalities........................................................................................................109
14.8 Ultrasound therapy ...........................................................................................109
14.9 Combined therapy.............................................................................................109
14.10 Laser therapy .....................................................................................................110
15 TECHNICAL SPECIFICATIONS........................................................................111
15.1 Appliance...........................................................................................................111
15.2 Specifications safety.........................................................................................112
15.2.1 Appliance.........................................................................................................112
15.2.2 Ultrasound heads ............................................................................................112
15.2.3 Laser probe .....................................................................................................113
16 ACCESSORIES..................................................................................................114
16.1 Standard accessories.......................................................................................114
16.2 Optional accessories........................................................................................114
17 EXPLANATION OF THE SYMBOLS.................................................................115
17.1 Symbols at the front side of the appliance.....................................................115
17.2 Symbols on the side and back of the appliance ............................................116
17.3 General symbols ...............................................................................................117
8 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
17.4 Symbols groups of current shapes................................................................ 117
17.5 Symbols current shapes.................................................................................. 117
17.6 Parameter symbols .......................................................................................... 119
17.7 Drawings of the current shapes...................................................................... 121
18 INDEX................................................................................................................ 123
COMBI 500 – Operating instructions - version 1.1 – 12/2001
9
2 SAFETY REGULATIONS
2.1 Electrical safety
The Combi 500 may only be used in a room equipped with conveniences meeting the legal
requirements in force. The Combi 500 must be connected to a
that meets the locally applicable requirements for medical rooms.
2.2 Explosion prevention
Do not operate the Combi 500 in a room where inflammable gases or fumes might be
present. Switch off the device before starting to disinfect or decontaminate the room where it
is placed, for instance.
2.3 Operational safety
2.3.1 Operational safety - Generalities
− The Combi 500 is suitable for continuous use.
− Using the Combi 500 together with a short wave or microwave appliance might have an
influence on the output of the Combi 500.
− Using the Combi 500 simultaneously with a high-frequency surgery apparatus might
lead to burns under the electro-stimulating electrodes.
− Patients with electrical implants (e.g. pacemaker) may only be treated after gaining
medical advice.
− Do not operate the Combi 500 in a wet room.
− Do not disinfect or sterilize the Combi 500.
− Regularly check if the insulation of the electrode cables and the electrodes themselves
is still intact. If this is not the case, replace the wiring and/or the electrodes.
− An appropriate and safe use of the Combi 500 is only guaranteed if one uses the
standard and/or optional accessories, mentioned in these Operating Instructions (
Chapter 16: ACCESSORIES)
− In order to warrant the safety of the Combi 500 for a longer period of time, we advise
you to have the unit itself and the accessories checked at least once a year during a
safety and technical control (
− The safety standards for
2.0 mArms/cm2. During iontophoresis treatments, however, we recommend not to
exceed the current density of 0.2 mArms/cm2. Overstepping might cause skin irritation
and burns.
− An optimal treatment starts with an examination of the patient. Based upon these
findings a treatment plan and treatment objectives can be established. One has to
control these plans and objectives very thoroughly during the treatment itself. In that
way, possible risks linked to the treatment can be minimized.
− Always keep these Operating Instructions in the vicinity of the appliance.
refer also to paragraph 2.7).
electrotherapy recommend not exceeding the current density of
properly grounded wall plug
see
10 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
2.3.2 Operational safety – while using lasers
− The radiation of a laser probe can cause a physiological effect. The laser beam is
invisible; the use of the laser by unauthorized persons or a longer exposure to the
radiation might cause injuries. That is the reason why any non-therapeutic exposure
should be avoided.
−
Never look into the laser probe during a laser therapy, and never point the probe to
somebody else’s eyes (e.g. the patient).
− The therapist as well as the patient must
GymnaUniphy furnishes 2 laser spectacles together with each laser probe 52. These
spectacles have an attenuating effect of more than 100. It is still possible to see the
controls and lights of the laser probe through the glasses. One may also use laser
spectacles having at least the following characteristics: I 100 – 1000 L2.
− Do not hold the laser probe in the vicinity of inflammable materials or liquids during the
treatment.
− The Combi 500 is equipped with an ignition lock to start the laser emission. In the event
that the Combi 500 is not used for laser therapeutical purposes, this locking key is to be
set in the “OFF” position (= horizontal). To avoid inexpert use when the Combi 500 unit
is not under the supervision of the therapists, it is strongly advised to switch the locking
key to “OFF” and to extract the key from the unit.
− The application of checks, modifications, operations or procedures deviating from those
mentioned in these Operating Instructions can lead to irresponsible exposures to laser
radiations.
wear laser spectacles all the time.
− The warning symbol Laser
laser will be operated.
must be affixed at the entrance of the room where the
2.4 Transportation and storage
The way it is packed up in its original wrapping, the Combi 500 unit is suitable for
transportation and storage (for a maximum period of 15 weeks) within the following limits:
- Temperature from –20 °C to +60 °C;
- Relative humidity from 10 % - 100 %, inclusive condensation;
- atmospheric pressure from 500 hPa - 1060 hPa.
2.5 Use of the Combi 500
The Combi 500 was exclusively designed to administer the following therapies:
electrotherapy, ultrasound therapy, combined therapy and laser therapy. The use of the
unit is strictly limited to authorised and expert personnel (trained in the application of the
therapies mentioned above). It is mandatory to follow the directives in these Operating
Instructions as closely as possible.
NOTE:
The ambient temperature for operating the Combi 500 is between +10
ºC and +40 ºC.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
11
2.6 Medical Device Directive
The Combi 500 meets the most recent adapted essential requirements of the Medical
Device Directive of the European Commission (93/42/CEE).
See Chapter 12: INTERFERENCES, WARRANTY, LIABILITY, SERVICE concerning the liability of the
manufacturer.
2.7 Technical Control
The Medical Device Directive of the European Commission (93/42/CEE) makes it
mandatory for the user of the Combi 500 to have the unit checked during a safety and
technical control at least once a year, and especially after all repairs. This is in accordance
with the directive mentioned above.
This safety and technical control consists of:
1. a visual control,
2. a safety check,
3. the examination of all the operating functions and the measurement of the output
signals,
4. the control of the alarm functions,
5. the measurement of the over current protective device,
6. the measurement of the ground leakage current and the patient leakage current, in
accordance with the EN 60601 safety standard,
7. the calibration of the laser detector,
8. the examination of the output of the laser probes.
The results of these checks must be recorded in the service logbook.
The service logbook can be found in the back of the “Treatment Guide” under the tab
SERVICE.
NOTE:
Safety and technical inspections may only be conducted by a recognized safety inspection body or by a
technician approved and qualified as thus by GymnaUniphy.
2.7.1 Inspection interval
The unit is designed in such a way that an annual inspection is sufficient. In the event that
the local legislation in the user’s country (or his insurer) imposes shorter intervals, one has
to comply with them.
2.7.2
12 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
Inspection results
The inspection has been carried out completely when al the topics of the annexed
inspection report (see tab SERVICE in the Treatment Guide) have been checked.
Abnormalities have to be adjusted (or repaired if necessary) before using the unit again.
The intention is that the user makes a certain number of copies of the inspection report, so
that there are a sufficient number of copies available for several controls.
NOTE:
Technicians authorized to do so by GymnaUniphy may only carry out r epairs. Contact your local G ymna dealer
to know their addresses.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
13
3 INSTALLATION
3.1 Introduction
At the beginning of these Operating Instructions you will find an exploded view of the Combi
500 and its accessories. The numbers in these Operating Instructions correspond to the
numbers on the drawings.
3.2 On receipt of your Combi 500 unit
Check if the Combi 500 was not damaged during the shipment.
Also check if the accessories are intact and complete.
(See Chapter 16: ACCESSORIES).
In the event of any damage and/or malfunction notify your supplier
working days after the delivery) by means of telephone, fax, e-mail or letter.
In the case of damage, the unit may
not be operated.
Mains voltage:
The Combi 500 is suitable for a rated mains voltage of 110, 115, 127, 220, 230 or 240 Volt
AC / 50-60 Hz. Check if the mains voltage matches the voltage on your own circuitry and
electricity supply system. The mains voltage of the unit can be easily adjusted by means of
a coin through the mains voltage selector switch
33
(on the bottom of the unit).
immediately (= within 3
3.3 Connecting and starting
− Carefully check the mains voltage
power point (input mains
29
at the backside of the appliance).
− Place the Combi 500 horizontally and stable.
− The ventilation opening
31
may not be covered.
− No objects may be put on the Combi 500.
− Do not let any liquid drop over the Combi 500.
− Do not put the Combi 500 in direct sunlight and do not put it above a heat source.
If there is no text on the display after switching it on, adjust the contrast by slightly turning
the contrast control
34
(at the backside of the unit).
(see paragraph 3.2) before connecting the plug to the
14 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
3.4 Language selection
− There is a choice between four languages: English, German, French and Dutch.
− The setting of a language is only possible if there is no treatment in progress.
− One has to proceed as follows: on the display Start menu, the key Return
must be
pressed and held during 3 seconds.
− Select the language (Green Keys).
− A selected language can be changed with the aid of the keys and .
3.5 Hooking up accessories on the connectors
3.5.1 Electrotherapy-connectors
1) The double-wired electrode cable
adhering electrode
ATTENTION:
• When using currents with a galvanic component, such as galvanic and diadynamic
currents, pulsating rectangular and triangular currents, the application of adhering
electrodes is strongly discouraged because of the danger of cauterisation and etching
effects (see also Chapter 14: SPECIFICATIONS)
2) One vaginal or anal stimulating probe, to be coupled directly to the electrotherapy
connectors
20 21
3) One rectal stimulating probe, to be connected through one cable of the double-wired
electrode cable
ATTENTION:
• Electrotherapy on the display at channel A = Output signal on the A output
• Electrotherapy on the display at channel B = Output signal on the B output
43
(the latter have to be connected by means of an adaptor 42).
.
37
.
20 21
37
has at each output a rubber electrode 38 or an
21
20
.
.
3.5.1.1 Vaginal, anal or rectal stimulating probes
For the treatment of e.g. several incontinence problems.
The Combi 500
recognizes the vaginal and the anal probes (= probes equipped with a DINconnector). As soon as one of these probes is connected, the unit will only select
alternating currents (TENS, NMES, and bipolar interferential currents) with a Constant
Voltage (CV) setting. All other current shapes may not be selected at that time
Chapter 14: SPECIFICATIONS.)
. (See also
COMBI 500 – Operating instructions - version 1.1 – 12/2001
15
WARNING:
The Combi 500 DOES NOT RECOGNIZE THE RECTAL PROBE and thus allows in
principle the use of all sorts of current shapes whenever connected.
In order to avoid unpleasant sensations and cauterisation or etching we advice to utilize
exclusively selected Constant Voltage settings (TENS, NMES, and bipolar intermediate
frequency currents) when using a rectal probe
See paragraph 7.7 for more information about the Constant Voltage.
3.5.2 The ultrasound connectors
Connect the multi-frequent ultrasound (US) head(s)
22 23
45
to an arbitrary US-connector
22 23
.
The Combi 500 automatically selects the US head that was connected last.
The lights on the US heads indicate which US head has been selected.
(see also paragraph 6.12.6)
3.5.3 The laser-connector 24
Either the Mono-probe
connected.
OPERATIONAL SAFETY OF THE LASER:
• The radiation of a laser probe can cause a physiological effect. The laser beam is
invisible; the use of the laser by unauthorized persons or a longer exposure to the
radiation might cause injuries. That is the reason why any non-therapeutic exposure
should be avoided.
• Never look into the laser probe during a laser therapy, and never point the probe to
somebody else’s eyes (e.g. the patient).
• The therapist as well as the patient must wear laser spectacles all the time.
GymnaUniphy furnishes 2 laser spectacles together with each laser probe 52. These
spectacles have an attenuating effect of more than 100. It is still possible to see the
controls and lights of the laser probe through the glasses. One may also use laser
spectacles having at least the following characteristics: I 100 – 1000 L2.
• Do not hold the laser probe in the vicinity of inflammable materials or liquids during the
treatment.
• The Combi 500 is equipped with an ignition lock to start the laser emission. In the event
that the Combi 500 is not used for laser therapeutical purposes, this locking key is to be
set in the “OFF” position (= horizontal). To avoid inexpert use when the Combi 500 unit
is not under the supervision of the therapists, it is strongly advised to switch the locking
key to “OFF” and to extract the key from the unit.
• The application of checks, modifications, operations or procedures deviating from those
mentioned in these Operating Instructions can lead to irresponsible exposures to laser
radiations.
48
(model 543) or the quadruple probe 53 (model 545) can be
• The warning symbol Laser must be affixed at the entrance of the room where the
laser will be operated.
16 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
3.6 Functional test
− During production the Combi 500 is thoroughly checked for electrical safety.
− When switching on the Combi 500, the microprocessor is performing an extensive test
In order to verify the correct functioning of the unit.
− Check if the display is functioning properly. If this is not the case, do not continue to use
the device and inform the repair services of your local Gymna dealer.
3.7 New owner
The ‘Medical Device Directive’ of the European Commission (93/42/CEE) prescribes that
this type of medical equipment should be traceable. That is why we are kindly requesting
every (new) owner to urgently give to the local Gymna dealer the name, address and other
relevant data of the
heads and laser probes >> important: these devices have their own serial number.
new owner, of the Combi 500 as well as its specific accessories US-
3.8 Liquidation
Turn in the Combi 500 and all its accessories to a company specialised in the liquidation
and recycling of electronic products and components. In those countries where there is a
“take back” option in force, please contact your local Gymna dealer.
In the event that the owner is willing to destroy the unit himself or if he is willing to take the
responsibility for doing this, the following information concerning environmental
consequences might be interesting.
The parts of the Combi 500 can be classified into three categories:
1) The basic units, wiring, electrodes, US heads, laser probes and the Treatment Guide
are to be considered as electronic or as small chemical waste. They consist of,
amongst others, lead, tin, copper, iron, a diversity of other metals and several manmade materials. In most of the countries this waste is classified as “small chemical
waste”. Refer to the national regulations in force in your country for that matter.
2) Sponges, sponge sachets and gels only hold organic material and therefore do not
need any special attention.
3) Packaging materials and the Operating instructions can be recycled. Depending on
the local organization of the waste disposal, they have to be turned in at dedicated
collecting points or they have to be evacuated with the regular dustman/ garbage
man.
NOTE:
In most of the countries it is not allowed any more to dispose off these kinds of appliances through the regular
garbage disposal channels (because of the man-made plastics and of the electronic components).
COMBI 500 – Operating instructions - version 1.1 – 12/2001
17
4 CONTROLS
4.1 Introduction
At the beginning of these Operating Instructions you will find an exploded view of the unit
and its standard accessories. The figures below correspond to those on that plan.
4.2 Controls, connectors, standard accessories
1. Display, screen.
2. Selecting a Menu or a Parameter (green keys).
3. Increasing and setting of a Parameter; browsing in the lists.
4. Decreasing and setting of a Parameter; browsing in the lists.
5. Key for the Channel selection between A or B.
6. Intensity control for Channel A.
7. Intensity control for Channel B.
8. Key Menu Electrotherapy.
9. Key Start Menu.
10. Key memory.
11. Key Ultrasound.
12. Key Combined therapy.
13. Key Laser therapy.
14. Key Help.
15. Key Return.
16. Key Enter
17. Key Pause.
18. Key Stop.
19. Testing eye Laser emission.
20. Connector Electrotherapy - Channel A.
21. Connector Electrotherapy – Channel B.
22. Connector Multi-frequent Ultrasound head 1.
23. Connector Multi-frequent Ultrasound head 2.
24. Connector Laser probe.
25. Indicator lights (yellow) Current passage per channel.
26. Locking key Laser.
27. Mains voltage switch.
28. Fuse holder.
29. Input mains voltage.
30. Label with data of the unit.
31. Ventilation opening.
32. Connector RS 232 for service purposes.
33. Selection Mains voltage (at the bottom of the unit).
34. Contrast adjustment of the screen.
35. Indicator light Stand-by (yellow).
36. Mains voltage cable.
37. Two-wire electrode cable.
38. Rubber electrodes.
39. Electrode sachets, alvose.
40. Elastic fixations.
18 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
41. Test plug V/V - 4mm.
42. Adapter cables 4 mm to 2 mm to connect adhering electrodes.
43. Adhering electrodes.
44. Stimulating electrode with sponge.
45. Treatment head Ultrasound 4 cm² (multi-frequency).
46. Contact gel - 150 ml.
47. Treatment Guide with Operating Instructions
48. Mono-probe Laser.
49. On/Off push button Laser probe.
50. Green LED: Laser probe.
51. Yellow LED: Laser probe.
52. Laser protecting glasses I 100 – 1000 L2 (TX = 0.01 @ 904 nm)
53. Quadruple probe Laser.
54. On/Off push button Laser probe
55. Green LED: Laser probe
56. Yellow LED: Laser probe
57. Label Quadruple probe Laser (type 545).
58. Label Mono probe Laser (type 543).
RECOMMENDATION:
CAREFULLY preserve the parts you do not use immediately (e.g. probe holder, bolts, socket head
wrench, key switch of the laser, set of spare fuses, …).
COMBI 500 – Operating instructions - version 1.1 – 12/2001
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5 SELECTION OF A TREATMENT
5.1 Different therapeutic possibilities - generalities
The Combi 500 is equipped with two channels separated from each other and serving for
electrotherapeutic purposes, one channel for ultrasound and one channel for laser
applications.
These channels can be adjusted independently from each other, this means that one can
treat two different indications simultaneously and administer two different therapies.
A concise overview of the therapeutic possibilities that can be administered
is given below.
Channel A Channel B
Electrotherapy Electrotherapy
Electrotherapy Ultrasound therapy
Electrotherapy Laser therapy
Ultrasound therapy Electrotherapy
Laser therapy Electrotherapy
Laser therapy Ultrasound therapy
Ultrasound therapy Laser therapy
Exceptional: not possible
Electrotherapy Laser therapy 545 probe
simultaneously
5.2 Start menu.
There are three different methods to adjust the unit.
1. By means of the Start menu
Via the Start menu the treatment possibilities are represented step by step.
These possibilities are the following: Objectives
Indication list
Program number
Diagnostic programs
2. By means of direct selection of the Therapeutic method.
See paragraph 5.3.
3. Recall the own designed programs by means of the treatment memory.
See Chapter 9 : TREATMENT MEMORY.
20 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
5.3 Therapeutic keys
The Therapeutic keys are at the left hand side of the screen and they constitute a rapid
way to come to a treatment method.
Key Start menu
Objectives, Indication list, Program number, Diagnostic programs and the list with
Contra-indications are now available.
Key Menu Electrotherapy
The current shapes can be directly selected.
Key Ultrasound therapy
The treatment display appears now immediately.
Key Combined therapy
The current shapes for the Combined therapy can be directly selected.
Key Laser therapy
The treatment method appears immediately.
Key Memory
Store the program, open it or erase it.
The different possibilities are described in detail in the following paragraphs.
See Chapter 6: GENERAL OPERATING INSTRUCTIONS for more details about the operation of the Combi
500 unit.
5.4 Selection of a treatment method by means of OBJECTIVES
The Start menu appears automatically the moment the unit is switched on.
The Start menu also appears when pushing the Start menu
In the Start menu select Objectives in order to select a specific therapy method.
Select Objectives
key.
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21
5.4.1 Objective Electrotherapy, example of a selection
Due to the fact that the objectives of the four proposed therapeutic methods Electrotherapy,
Iontophoresis, Ultrasound therapy or Laser therapy often are essentially different from each
other, one gets the choice out of a list of therapeutic
Select Electrotherapy
Subsequently a list with Objectives for Electrotherapy follows.
Select Pain relief
Followed by a list of specifications
Select Acute
methods first of all.
22 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
Select ET Conventional
See paragraph 7.6 for more information about the difference between ET Conventional and ET Sequential.
Subsequently a window appears with the recommended Therapy method
screen)
(lower line of the screen).
, together with the parameters (see both displays below) and the advice for the intensity
(upper line on the
When a parameter is selected, one is able to
using the keys
and . The advice about the intensity disappears for a while and
modify the value of the selected parameter by
instead one sees the adjusting range of the selected parameter.
5.4.2
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23
Objective Laser therapy, example of a selection
The Start menu appears automatically when the unit is switched on.
The Start menu also appears when pushing the key Start menu
Select Objectives out of the Start menu in order to select a specific Therapy method.
Select Objectives
Select Laser therapy
Select Pain relief
Subsequently one can make a choice between Myogene and Neurogene pain points.
24 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
Select Neurogenic pain points
The screen
probe
53
(type 545) for the treatment.
(see below) now proposes either the Mono probe
48
(type 543) or the Quadruple
Make a selection of the type of probe and connect the correct probe (when connecting the
wrong probe, a message will appear in the lower part of the screen).
Select Mono probe - type 543
The parameter Probe type is never outlined
(see below). This means that this parameter
cannot be selected. The Combi 500 detects the connected probe automatically.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
25
OPERATIONAL SAFETY OF THE LASER
• The radiation of a laser probe can cause a physiological effect. The laser beam is
invisible; the use of the laser by unauthorized persons or a longer exposure to the
radiation might cause injuries. That is the reason why any non-therapeutic exposure
should be avoided.
• Never look into the laser probe during a laser therapy, and never point the probe to
somebody else’s eyes (e.g. the patient).
• The therapist as well as the patient must wear laser spectacles all the time.
GymnaUniphy furnishes 2 laser spectacles together with each laser probe 52. These
spectacles have an attenuating effect of more than 100. It is still possible to see the
controls and lights of the laser probe through the glasses. One may also use laser
spectacles having at least the following characteristics: I 100 – 1000 L2.
• Do not hold the laser probe in the vicinity of inflammable materials or liquids during
the treatment.
• The Combi 500 is equipped with an ignition lock to start the laser emission. In the
event that the Combi 500 is not used for laser therapeutic purposes, this locking key
is to be set in the “OFF” position (= horizontal). To avoid inexpert use when the
Combi 500 unit is not under the supervision of the therapists, it is strongly advised to
switch the locking key to “OFF” and to extract the key from the unit.
• The application of checks, modifications, operations or procedures deviating from
those mentioned in these Operating Instructions can lead to irresponsible exposures
to laser radiations.
• The warning symbol Laser must be affixed at the entrance of the room where
the laser will be operated.
Introduce the locking key into the contact, or in the event that the key is in the wrong
position, the following message appears on the screen.
26 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
5.4.3 Objective ET Iontophoresis or Ultrasound therapy, example of a
selection
In order to select the treatment method ET Iontophoresis or Ultrasound therapy through
Objectives, one can proceed in the same manner as was done in the representations above
‘Objectives > Electrotherapy'
paragraph 5.4.2)
(see paragraph 5.4.1) and 'Objectives > Laser therapy' (see
5.5 Selecting a treatment method through INDICATION LIST
The Start menu appears automatically when the unit is switched on.
The Start menu also appears when pushing the key Start menu
.
Out of the Start menu, one selects Indication list
(see below).
Select Indications
An alphabetical list is displayed showing all the Indications on screen.
Behind a specific Indication, there is an abbreviation of the advised Therapy method,
That is to say ET = Electrotherapy, IO = Iontophoresis, LA = Laser therapy, US = Ultrasound
therapy, CO = Combined therapy.
It is possible to browse through the indications by using the keys
and .
Select Arteriosclerosis
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27
After having selected one of the Indications one can either further specify it (e.g. acute), or
choose from the desired therapy methods
(see below).
Select Intensive, local
The display shows the recommended Therapy method, together with the parameters and
the advice for the intensity, where both are tailored to the Indication.
See paragraph 6.6 for more explanation about the modification of a parameter.
28 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
5.6 Selecting a treatment method through a PROGRAM-
NUMBER
The Start menu appears automatically when the unit is switched on.
The Start menu also appears when pushing the key Start menu
All treatment programs have their
Out of the Start menu one selects a Program number
This is the quickest way to enter into the desired program.
The second line (
the correct program number through the keys
see below) gives concise information about the selected program. Select
own program number.
(see below).
Select Program number
and
Push the key
COMBI 500 – Operating instructions - version 1.1 – 12/2001
29
When the desired number is reached, one pushes the key Enter
Press the Enter key
The parameter display appears immediately.
See paragraph 6.6 for more explanation about the modification of a parameter.
5.7 Selecting programs for DIAGNOSTICS
A certain number of current shapes can be applied diagnostically.
Hereby different possibilities are opened enabling the therapists to determine in a simple
way the Rheobase and the Chronaxie or dressing up an S-D curve.
Through a certain number of programs one can localize and treat pain points.
The Start menu appears automatically when the unit is switched on.
The Start menu also appears when pushing the key Start menu
30 COMBI 500 – Operating Instructions - version 1.1 - 12/2001
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