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 (
Chapter16: 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
− 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:
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.
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
− 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 theB 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, itis 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
− 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).
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.
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.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
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.
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, itis 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.
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 .
SelectArteriosclerosis
COMBI 500 – Operating instructions - version 1.1 – 12/2001
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.
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
In order to determine for instance the Rheobase and the Chronaxie, one starts in the Start
menu
and one chooses Diagnostic programs.
Select Diagnostic programs
The display shows a list with program options for Diagnostics
.
Select Rheobase and Chronaxie
Subsequently the parameter window Rheobase is displayed.
See Chapter 8: DIAGNOSTIC PROGRAMS for detailed information about the diagnostic possibilities of the
Combi 500 unit and paragraph 6.6 for more information on how to adjust the param eters.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
31
5.8 Direct selection of a CURRENT SHAPE
Push the key Electrotherapy
The display shows several main groups of the current shapes
In this manner one finds and selects the desired current shape very quickly.
Select Unidirectional
The display shows a list of current shapes from which one can choose.
Select Direct current
The display immediately shows the parameters of the selected current shape.
See Chapter 14: SPECIFICATIONS for an overview of the current shapes and their parameters and paragraph
6.6 for more information on how to adjust the parameters.
Push the key Ultrasound therapy
The display immediately shows the treatment screen
The treatment is started immediately after turning open the intensity.
ATTENTION:
• Before starting a US treatment, one must first apply GymnaUniphy Contact-Gel to the
treatment surface of the US head.
• Move the US head dynamically on the skin during the treatment, in order to prevent too
high intensities on one single spot (which could cause burns!).
NOTE:
not possible to select 2 US treatments at the same time. When there is no US head connected, the
It is
parameter ‘ERA’ remains empty. In the channel window, no US head symbol is displayed. In the lower part of
the screen, a message is displayed.
(see below).
5.10 Direct selection of the COMBINED THERAPY
Push the key Combined therapy
The display shows a list of 6 different current shapes for the Combined therapy. One has to
make a choice out of this list
wants to apply the Combined therapy.
(see below). One has to select the current shape by which one
Select Conventional TENS
COMBI 500 – Operating instructions - version 1.1 – 12/2001
33
The control button for the intensity of channel A
is always for the Electrotherapy part.
The control button for the intensity of channel B
is always for the Ultrasound part.
See paragraph 6.12.7 for further explanation.
ATTENTION:
• The safety standards for the Combined therapy recommend a current density of 2.0
mA
/cm2. Exceeding this limit might cause skin irritation and burns.
rms
• Before starting a US treatment, one must first apply GymnaUniphy Contact-Gel to the
treatment surface of the US head.
• Move the US head dynamically on the skin during the treatment, in order to prevent too
high intensities on one single spot (which could cause burns!).
NOTE:
When a therapy is already administered through one channel, it is not possible to select the Combined therapy.
The ongoing treatment has to be terminated first in such a case.
Press the key Laser therapy
The display immediately shows the treatment screen
the moment one activates the pushbutton on the laser probe.
See paragraph 6.6 for more information about the modification of the parameters.
OPERATING SAFETY OF THE LASER THERAPY:
• See paragraph 2.3.2.
NOTE:
If there is no laser probe connected, then the parameter Probe type remains empty.
There is no representation of a symbol Probe in the channel window.
(see below). The treatment is started
5.12 Selection of a treatment out of the MEMORY
One can store treatments in the memory
See Chapter 9: TREATMENT MEMORY for a detailed discussion about this principle.
and recall the stored treatments.
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35
6 GENERAL OPERATING INSTRUCTIONS
6.1 Introduction
The Combi 500 offers numerous possibilities and still remains very easy to operate. The
operating principle is logical and consistent. As soon as one gets acquainted with the
functions of the various keys and controls, the operational use of the unit is self-explanatory.
In this chapter, the functions of the keys and controls not yet treated previously will be
discussed.
See Chapter 4: CONTROLS for a short and concise description of the controls, the numbers of these controls
correspond to the numbers of the exploded view of the Combi 500 unit and its accessories in the beginning of
these Operating Instructions.
See Chapter 7: SOME PARTICULAR THERAPEUTICAL AND PARAMETER POSSIBILITIES.
See Chapter 18: INDEX for the alphabetical index. Here one can quickly find out on what pages of the Operating
Instructions the specifically searched reference is discussed.
6.6 Green keys – select menu or select parameter / modify
The function of the green keys is different from program to program and from menu to
menu. This function corresponds to the item next to the green key.
Through these keys:
a) one selects a menu;
After this selection one is automatically guided into the next display.
That way, one is guided step by step to a program display/treatment display.
b) one selects a parameter;
c) one modifies the selected parameter;
In order to modify the selected parameter one proceeds as follows:
• parameters subject to modifications are outlined.
• A selected parameter remains
As long as the parameter remains in this reverse image, one can modify the
parameter by means of the keys
NOTE:
At the lower side of the screen one can see the setting range of the selected parameter (in 'reverse/ negative
image').
Specific parameters are outlined and cannot be modified anyhow. Such a parameter can be
selected however for the function HELP
If in the event of Interference
frequency, the modulation time is not relevant, and it cannot be modified either.
during 3 seconds into ‘reverse or negative image’.
and
?
(see below), the minimum frequency is equal to the maximum
264-pole IF
15:00
CC 0
Carrier wevekHz4
Hz100Min. frequency
Hz100Max. frequency
Parameter that can be
Sweep mode
Treatment time15:00
selected, but that cannot
be adjusted now because
of the actual parameter
setting
Parameters that cannot be selected (and that cannot be modified) are not outlined
(exception is the Electrode Placement).
COMBI 500 – Operating instructions - version 1.1 – 12/2001
39
In the case of a Laser therapy, the parameter «type probe» (see below) is not subject to be
selected.
Without outlining (boxing),
this means that the parameter
cannot be selected
1:00
LASER THERAPY
Probe type
32
.00
0
.00
0
FrequencykHz8
Sweep modeON
1:00Treatment time
6.7 The UP- and DOWN-keysand
These keys have a double function:
1) they allow browsing through a list,
2) they make it possible to modify the value of parameters.
6.7.1 Browsing with the keys and
In the event that the screen shows more than 6 menus or parameters to make a selection,
one can be transferred into different menus or parameters with the help of these keys. The
browsing direction is indicated in the lower right corner of the display.
NOTE:
This is only possible when
Browsing can be done up or down. The browsing direction is visualised by the signs
σ and τ in the lower right corner of the display
6.7.2 Modifying parameters with the help of the keys and
One can modify the value of a selected parameter with the help of these keys.
The longer one presses the key, the quicker the values modify.
NOTE
When releasing a key and subsequently pressing the key again, the values will modify very slowly again. When
pushing the key even longer, the modifications will be carried out at a higher speed a gain.
The lower line of the display gives the setting range of the selected parameter.
The parameter TREATMENT TIME
- press 1 x the Green Key: time modifies by the
- press 2 x the Green: time modifies by the
(see below) can be modified using the keys and
minute.
second.
6.8 Return key
This key allows you to return to the previous window.
EXCEPTION : one can browse through a list (e.g. an Indication list) by using the keys
and .
If one is inside a list, one can always go back to the previous menu by pressing the Return
key
6.9 Help key ? - Request detailed explanation
The Combi 500 assists to the maximum extent possible when setting up therapeutic
treatment.
Depending on the menu one is working in, it is possible to request some background
information with the aid of the Help key
?
COMBI 500 – Operating instructions - version 1.1 – 12/2001
41
If no parameter is selected (see below), one receives background information concerning the
?
current shape by pressing the Help key
In the event that a parameter has been selected
information concerning the parameter by pressing the Help key
(see below), one receives background
?
NOTE:
If the
parameter cannot be selected (and is thus not outlined), information about this parameter is offered
through the parameters that can be selected (they are outlined) and that are in direct relation to the envisaged
parameter.
By means of the Return key
one goes back to the previous display starting from the Help
6.12 Intensity buttons and - content of the channel
windows
With the intensity buttons- channel A by means of button
of button
one can adjust the intensity of the envisaged channels.
and the channel B by means
The left hand side of the display shows as to what the envisaged channel windows is
concerned:
• the set intensity
− at Constant Current* in milliampères (below at the left hand side)
− at Constant Voltage* in Volts (below at the right hand side)
• the treatment time.
In both cases the intensity bar represents the adjusted and set current in a symbolic way.
* Also refer to paragraph 7.7
CV30
The preset peak intensity
In the amplitude bar the
actual current is
displayed symbollically
35:00
red-
35:00
CC 40
The set value of the
open circuit voltage
In the amplitude bar
the actual current is
displayed symbollically
red-
6.12.1 Electrotherapy 4-poles – adjust intensity
In the case of 4-pole current shapes, both the channels A and B are active simultaneously.
Presetting the intensity is in this case
always carried out by means of the LEFT intensity
button
The display then shows the preset intensity in the envisaged channel window.
6.12.2 Bursts – adjust intensity
In the case of burst currents there is a certain serial interval (stimulus time) and a serial
pause (stimulus pause). As soon as one turns at the intensity button in the case of bursts a
new serial interval is started automatically. That is the reason why one does not have to
take into account the serial interval and pause, when opening up the dose.
6.12.3
COMBI 500 – Operating instructions - version 1.1 – 12/2001
45
Alternating channels - adjust intensity
Refer to paragraph 7.12 for more information about the alternating channels.
They are bursts too and thus one can speak of a certain serial time and pause.
The conduct is the same as the one described in
paragraph 6.12.2.
NOTE:
Due to the fact that the channels are operating alternatively, there is
stimulation on both channels.
never a question of simultaneous
How does the Combi 500 unit react if the intensity control button of the channel is turned,
that is in a serial pause at that very moment (the stimulation is than present on the other
channel) ?
The active channel is switched back to zero as expeditiously as possible. After that, the
channel that the therapist wants to become active is adjusted with a new intensity,
which is immediately sensed by the patient. In the event that no new dose is set, the
Combi 500 unit proceeds the treatment according to the preset parameters.
6.12.4 Iontophoresis – adjust intensity
In a certain number of programs for Diagnostics and in the case of programs for
Iontophoresis, the intensity is modified:
• in steps of 0.1 mÂ, from 0 to 20 mÂ;
• in steps of 1 mÂ, above 20 mÂ.
• For safety reasons we strongly recommend a maximum intensity per electrode-surface:
• Intermediate frequent rectified rectangular current: 0.25 m x electrode-surface area in
cm2.
• Rectified direct current: 0.20 m x electrode-surface area in cm2.
• If the maximum recommended intensity is exceeded, the message 'Risk for skin
deterioration' will be displayed.
IMPORTANT:
Before boosting the intensity, one has to fill in oneself the electrode surface area. This is
not done automatically!
For Iontophoresis a sterilised gauze has to be used. For more information you can select
the parameter INFORMATION in the Iontophoresis program.
WORK IN A SAFE WAY:
When applying Iontophoresis, the intensity is adjusted between 0 - 20 m in steps of 0.1
mÂ. In that manner a very accurate dosing is possible.
In order to prevent cauterisation or burns we recommend the use of a maximum intensity of
This is a sequence with a pre-programed succession of current shapes following each other
in a “step by step” mode, after a preset time frame. The desired intensity is adjusted during
the first sequential step.
NOTE:
In order to protect the patient, switching to the next sequential step is not always possible at the same intensity
level. Every now and then it is necessary to adjust the intensity manually or to restart at the very beginning.
See paragraph 7.6 for more elaborate information about Sequential programs.
6.12.6 Ultrasound therapy - adjust intensity
7:30
0.0
0
.00
- The Îset indicates the preset ultrasound intensity.
- The Ppk indicates the real peak ultrasound output power.
When adjusting the intensity by means of the intensity control buttons
and the
Iset-value will change on screen.
If there is sufficient contact with the skin, the peak output power is displayed.
If there is an insufficient contact with the skin, the peak output power is 0.0 W.
ATTENTION:
• Before starting the US treatment, one has to apply GymnaUniphy Contact-Gel upon the
area to be treated.
• The US head must be moved dynamically during the treatment in order to prevent a high
The Combi 500 unit gives a feedback of the contact-control of the US head to the patient’s
skin. Here below, you see an overview of the graphical representation.
1. Contact detection bar I = zero
2. Contact detection bar: bad contact
3. Contact detection bar : sufficient contact
4. Contact detection bar: good contact
5. Contact detection bar: very good contact
NOTE:
In the event of a bad contact (2), the treatment time and the Ppk will go to 0.0 Watt. Whenever there is sufficient
contact again (3), the treatment time resumes its course and the peak output power is displayed once again.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
47
6.12.6.2 Multi-frequent Ultrasound head in the case of a US therapy
One can connect two US heads to the Combi 500 unit. The Combi 500 always selects the
head that was connected in the last position. The other US head connected is selected by
modifying the parameter ERA.
The parameter ERA can only be adjusted if there are two US heads connected (see below).
ERA can be modified by means of this parameter, that is to say that one changes the US
head.
In order to test the US head before starting a treatment, one can immerse the US head in a
bowl of water (18 °C). Increase the intensity and check in the channel window if the Ppk
increases.
With this parameter, one can modify the ERA.
This means a swapping of the US heads
There are two indicator lights on the US head. They give information about the US emission.
Blinking green light The US head is properly connected.
Continuous green light The US head is selected.
Continuous yellow light There is US -emission.
Blinking yellow/green light There is no contact with the skin.
Blinking yellow light End of the treatment.
6.12.7 Combined therapy - adjust intensity
During the Combined therapy both channels A and B are active simultaneously. The setting
of the Intensity for the Electrotherapy is in this case always done by means of button
The setting of the Intensity of the Ultrasound than always happens with button
On screen one can read the adjusted values on the relevant channel windows.
ATTENTION:
• The safety standards of the Combined therapy recommend a current density of 2.0
mA
/cm2. Exceeding this limit can cause skin irritation and burns.
rms
• Before starting the US treatment, one has to apply GymnaUniphy Contact-Gel upon the
area to be treated.
• The US head must be moved dynamically during the treatment in order to prevent a high
intensity at one spot (burns!).
6.12.7.1 Multi-frequent Ultrasound head used during the combined therapy
Refer to paragraph: 6.12.6.2. for the behaviour of the multi-frequent US head during the ultrasound therapy.
Whenever there is a bad contact between the US head and the skin,
− The adjusted intensity (in Volts) for the Electrotherapy remains unchanged,
− The intensity (visible on the intensity bar) remains unchanged,
− The treatment time stops,
− The Ultrasound peak power Ppk goes to 0.0 Watt.
As soon as there is again sufficient contact, the intensity for the electrotherapy as well as for
the Ultrasound (peak power) increases. The treatment time also resumes its course.
NOTE:
The contact detection bar represents the contact situation graphically (see paragraph 6.12.6.2).
ATTENTION:
• The safety standards of the Combined therapy recommend a current density of
2.0 mA
/cm2. Exceeding this limit can cause skin irritation and burns. Before starting
rms
the US treatment, one has to apply GymnaUniphy Contact-Gel upon the area to be
treated.
• The US head must be moved dynamically during the treatment in order to prevent a high
intensity at one spot (burns!).
6.12.8 Laser therapy - total energy dissipated
During the laser therapy no
The treatment time and the frequency are filled in; the treatment is
0:30
.00
0
0
.00
started by pressing the push button on the laser probe. The push
button must be pressed and held during the complete treatment.
Only under these conditions is there laser emission and the
treatment time is running as well.
As the treatment time passes by, the Etot-value increases in
nominal value every second with a value called P
: this is the preset average laser power.
It is the product of the energy per impulse and the frequency and it is expressed in
microWatt (µW) or milliWatt (mW).
: it is the total of administered laser energy of the current treatment.
It is the product of Pset and the treatment time and it is expressed in milliJoules (mJ) or
Joules (J).
use is made of an intensity regulator.
set.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
49
6.12.8.1 Laser probe
One laser probe can be connected to the Combi 500 unit. The Combi 500 always displays
the connected Laser probe on the screen if the Laser therapy has been selected. There are
two indicator lights on the Laser probe representing the activity of the probe.
The following activities are possible:
Continuous yellow light The laser probe is active and there is emission.
Continuous green light The laser probe is detected but there is no emission.
6.12.8.2 Testing the Laser probe –during the treatment
One can test if the Laser probe actually emits with the Laser eye
19
.
The Laser probe is tested as follows:
Go to the parameter- or intensity screen for the Laser therapy.
− Put the Laser probe in its upright position just straight on the Laser testeye
19
.
− Press the key on the Laser probe.
− The symbol Laser test
appears in the intensity window.
A
20:00
Symbool
Lasertest
80.5
Pset
Etot
50.5
mW
mJ
If one wants to test the Laser probe in a more specific way, this should be done by means of
System settings
6.12.9 Intensity - end of treatment, content of the channel windows
If the treatment time is set, its countdown starts until the intensity is tuned open. In the case
of Laser therapy the treatment time is counted down until the push button is pressed on the
probe itself. As soon as the treatment time is over, the units gives a beep signal; the
intensity is automatically running back to zero. In the intensity bar, a symbol indicates that
the treatment is over
value.
NOTE:
In the case of a Laser therapy this symbol ‘end of treatment’ will not appear. The Etot-value remains on screen
(total of the administered laser energy of the current treatment), and this until a new laser treatment can be
started.
If the treatment time is set to 0:00, (only possible for Electrotherapy programs), one
determines oneself the moment when the treatment should be finished and this by turning
the intensity back (to zero).
(see below) For the Ultrasound this symbol is coinciding with the Ppk
6.13 Pause key - interrupt the treatment temporarily
If - during a current treatment – one presses the Pause key
selected channel (in the case of 4-pole current shapes both channels) the treatment time
will stop, while the intensity runs back to zero.
There are no changes to the parameter setting of that specific channel.
When one presses the Pause key
a second time start, the treatment is started up again.
The intensity gradually increases up to the preset level before and the treatment time starts
running again.
In order to put the other channel that is active at that very moment, into the pause position,
this channel must be selected first before pressing the Pause key
COMBI 500 – Operating instructions - version 1.1 – 12/2001
, in the at that very moment
51
For the Electrotherapy (see below) the intensity bar indicates that the channel is in the Pause
state.
In the case of Ultrasound the Pause comes instead of the Ppk value.
NOTE:
The Laser therapy cannot
laser is than in a sort of pause state. The Etot-value remains indicated in the relevant channel window.
be set in pause. In the case of Laser therapy it is sufficient to release the probe, the
6.14 Stop key - interrupt the treatment immediately
As soon as the patient or the therapist presses the Stop key during the treatment, the
intensity is immediately reset to zero for all active channels
have changed the parameter settings of the current shapes for instance, the modified
parameter setting would remain on screen. In order to proceed with the treatment, one must
adjust the intensity once again.
During the Electrotherapy
(see below) the intensity bar indicates that the channel is in the
Stop position.
In the case of Ultrasound, the stop comes instead of de Ppk value.
NOTE:
The Laser therapy cannot
probe, the laser is than in a sort of pause or stop state. The Etot-value remains indicated in the relevant channel
window.
be set in the stop mode. In the case of Laser therapy it is sufficient to release the
If the Combi 500 unit is not used during 10 minutes, the appliance automatically switches to
the ‘Stand-by’
35
mode.
The screen and the background lighting distinguish and the yellow indicator light
illuminated. A simple push on any key makes the unit ready for use again.
See Chapter 10: SYSTEM SETTINGS AND BASIC SETTINGS to modify the Stand-by time.
remains
COMBI 500 – Operating instructions - version 1.1 – 12/2001
53
7 SOME PARTICULAR THERAPEUTICAL AND
PARAMETER POSSIBILITIES
7.1 Introduction
In Chapter 6 The general Operating Instructions of the Combi 500 unit have been treated.
The Combi 500 unit offers a certain number of particular current shapes and/or
parameters.
When having questions about certain current shapes or parameters, we recommend
the use of the HELP key ?. The questions are answered in an expeditious and
simple manner.
7.2 CONTRA-INDICATIONS on the display
The Start menu offers the option Contra-indications at the lowest line of the display.
During the selection of the Contra-indications the screen gives a certain number of
therapeutical possibilities
Subsequently, a list with Contra-indications follows with reference to the Electrotherapy
See Chapter 11: INDICATIONS AND CONTRA-INDICATIONS for more information.
one returns back to the Start menu.
7.3 The option INFORMATION
When selecting a treatment by means of the input Objectives or Indications list, one
encounters the option Information on the parameter screen.
When selecting Information, the display indicates the following information:
− motivation of the selection of the recommended treatment methodology and the
parameter setting;
− advise about the frequency of the treatment;
− possible alternative treatments.
When pressing the key Return
one comes back into the previous screen.
7.4 Electrode placement, ultrasound heads and laser probes
When selecting a program via the Indication list, one gets - if so desired - a recommendation
about the exact emplacement of the Electrodes, Ultrasound heads Laser probes, with a
reference to a clear and detailed colour picture in the TREATMENT GUIDE
47
.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
55
The next 6 displays show how one can find for instance via Electrode Placement the
corresponding picture numbers in the Treatment Guide.
Select the Start menu from the input Objectives, subsequently select the Therapy method
(see below, see also paragraph 5.4).
Select Iontophoresis
A list with objectives for Iontophoresis follows
(see below).
See Anti-inflammation
In a certain number of cases one can now make a selection for oneself out of a number of
appropriate medications in accordance with the selected objective
(see below).
Select Hydrocortisone
COMBI 500 – Operating instructions - version 1.1 – 12/2001
59
During the applications for Iontophoresis a recommendation for the intensity appears in the
lower part of the display
(see below).
• For safety reasons we recommend a maximum intensity per electrode-surface area.
• Rectified continuous current: 0.20 m x electrode surface area in cm2.
• If one exceeds the maximum recommended intensity, the message 'risk for skin
deterioration' appears.
IMPORTANT:
Before opening the intensity, one must fill in the electrode surface area used. This is not
done automatically!
For Iontophoresis one must use a sterilised gauze. For more information: select the
parameter INFORMATION of a program for Iontophoresis.
WORK SAFELY:
In the case of Iontophoresis the intensity is set between 0 - 20 m in steps of 0.1 mÂ. This
allows very accurate dosage.
In order to prevent cauterising or burns we recommend using a maximum intensity of 0.1
mA
/cm².
rms
NOTE:
When selecting Iontophoresis via the input Rectified Currents (in the menu Electrotherapy) one selects the
medication oneself out of the recommended list.
When selecting a therapy via the input Objectives, in most of the cases one gets the choice
of a conventional
A SEQUENCE is a pre-programd succession of current shapes following up each other in a
“step by step” way, after a previously set time.
Advantages:
• in an Electrotherapy treatment some logically ordered objectives can be realised;
• if the objectives are identical, one can lay different accents;
• a build up is given that joins <preparation- most important effect – cooling>.
7.6.2 Sequential current shapes – intensity
Every sequential step is characterized by its own parameter settings and its own treatment
time. Recommendations are given concerning the intensity to be applied.
What does the intensity do when switching to the next sequential step?
− If safety conditions permit doing so, the intensity, set in the previous step, is maintained.
− Or one has to apply a new intensity turning up the appropriate button from zero on.
If there is an automatic intensity transfer for all
displayed on screen just behind the sequential program number.
In the other case ‘MANUAL’ is displayed, meaning that the therapist himself must adjust
once or several times to the recommended intensity during the treatment.
simple therapy shape of a sequential therapy method.
sequences, the message ‘AUTO’ is
7.6.3 Sequential current shapes – selection
A sequential current shape can be adjusted:
− by using the input Objectives;
− or directly via the Program number.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
61
In this example (see below) a sequential current shape is set via Objectives > Electrotherapy
> Muscle training > Pelvic re- education
(see paragraph 5.4.for the setting of the Objectives).
Select Mixed incontinence
Subsequently follows the choice between Conventional and Sequential
(see below), and the
mentioning of the treatment duration and the program number. (Sequential programs
display whether or not the intensities are adjusted automatically or not when switching
steps; <auto> or <manual>).
Select ET Sequential
The overview of the selected sequence appears on screen
OR in this specific case the option Sequential step
next sequence (e.g. when one wants to skip the preparatory part of the treatment).
(see below) can be selected to choose the
Select Sequence step number
One can set a bigger step number by means of the
The option Step parameters gives detailed information about the parameters of the selected
step.
The example
Parameters of sequential current shapes cannot
beginning from this window and turning open the intensity.
With the aid of the Return key
of the Sequences.
(see below) shows the parameters of Sequence step 1.
be modified. The treatment can also start
one is transferred back again into the overviewing display
key.
7.7 Constant Current - Constant Voltage
7.7.1 Generalities
The Combi 500 unit offers for a certain number of current shapes Constant Current as well
as Constant Voltage. When applying a dynamic electrode technique, we recommend the
use of the setting Constant Voltage. This prevents unpleasant sensations for the patient
when moving back and forth with the electrode.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
63
7.7.2 Pelvic re-education
The Combi 500 unit can be equipped with some probes for the treatment of incontinence
complaints.
As soon as the vaginal or the anal probe is connected to the Combi 500 unit, the device will
recognize this probe. In order to prevent unpleasant sensations the unit will only apply
alternating currents with a Constant Voltage setting (TENS, NMES and 2-pole interferential
currents) from now (this is done automatically). All other current shapes are inaccessible at
that moment.
ATTENTION:
The unit does not recognize the rectal probe. The device basically allows all kind of current
shapes. However, we strongly advise the sole use of a Constant Voltage setting when working with the rectal probe.
NOTE:
The application CC or CV is clearly indicated in the channel window.
7.8 Setting different current or therapy forms per channel (A +
B)
The Combi 500 unit is equipped with two
other. Thus, two indications, even with two different therapies, can be treated
simultaneously. The manner if setting is very simple.
First, one has to adjust the first channel.
Then, by means of the Channel selection key
below).
If the treatment of Channel B was prepared already by means of a (former) current shape
applied onto the channel B, the adjusted current shape will appear on screen.
If this is not the case
still can be set for Channel B.
(see below) the window Start menu will pop up so that the therapy mode
IMPORTANT:
In the other channel an other therapy mode might be selected via the selection of
Electrotherapy , Ultrasound therapy, Combined therapy , Laser therapy, the Start menu or
the Memory menu.
7.9 Both channels (A + B) – automatic copying of the same
current shape
It is possible to set the same parameters for the second channel as they are for the settings
of the first adjusted channel. In that case we recommend to switch the parameter Automatic
Copying to ON in the System settings
After having copied these parameters, they still can be adapted if necessary, or even
another therapy method might still be selected according to the same manner as described
above.
In the example
(see below) a 2-pole current shape is applied to channel A.
In the System settings the option Copy parameters to another channel is in the ON position.
(see chapter 10: SYSTEM SETTINGS AND BASIC SETTINGS).
Select channel B via key
COMBI 500 – Operating instructions - version 1.1 – 12/2001
65
The parameters set for channel A are automatically copied in channel B (see below). Result:
identical programs are set in both channels (whilst the parameters themselves can still be
modified).
NOTE:
When pressing the key Channel selection
selected channel will be emptied.
and subsequently the Return key the channel window of the
7.10 Modify Standard programs
One has immediate access to the menu via the therapy keys (at the left hand side of the
screen):
Electrotherapy
In these menus the entire standard programs of the current shapes and the therapy
methods are defined. The program number of a standard program is always smaller than
50, so that they are easy to recognize. The recommended parameter values can be
modified very easily.
Attention: modifying the standard programs is only possible by means of the direct keys (at
the left hand side of the screen).
The modified standard programs can be stored with the same program number, if
desired so.
Permanent parameter modifications in a standard program are stored in the menu Memory
by means of the Memory key
A message is displayed to confirm this.
When pressing the Enter key
program number remains in effect.
the standard program is modified and the original
7.11 Expert Mode & Expert Times
NMES current shapes offer an option called Expert Mode. There is a certain number of
particular parameter possibilities ‘hidden’ behind this option. They represent specialistoriented parameters that most probably will not be set for all the treatments. After having
selected the option Expert Mode, the specialist-oriented parameters are displayed on
screen and they can be adjusted according to the specific preferences.
By means of the Return key
Any explanation about the different parameter possibilities can simply be called while
selecting the envisaged parameter and subsequently pressing the Help key
By means of the Return key
We will elucidate some Expert Modes now and their functions in the paragraphs below.
one is sent back to the previous parameter screen.
?
one is sent back to the parameter screen.
7.11.1 NMES-currents – special mode
Generally speaking, NMES-currents are utilised in applications of muscle stimulation. In the
case of NMES-currents, the parameter Special
The default setting of the parameter Special Mode is the OFF position.
One can select three Special Modes with the Combi 500 unit.
7.11.1.1 Active rest (REST)
Whenever selecting the option Rest, there is still stimulation at a lower frequency (this one
being adjustable) during then OFF periods. The Rest intensity is adjustable (in % of the
intensity set already) as well.
Advantage: during the ‘rest period’ one reaches the ‘muscle pumping effect’; hereby the
blood circulation is activated and the patient’s convalescence is stimulated.
Mode can be adjusted via the Expert Mode.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
67
7.11.1.2 Use of the second ON period (ON2)
As soon as ON2 is set, two independent ON periods are applied alternatively (ON and
ON2).
The frequency and the intensity of both periods can be set independently (for ON2 in
% of the value set for the ON-intensity).
Advantage: prevents adaptation and stimulates ‘slow twitch’ as well as ‘fast twitch’ tissue
alternatively.
7.11.1.3 Frequency variation (
Whenever this parameter is selected, during the ON-time, the set frequency is automatically
varied. Per ON-time, there is a diminution of 5 % until a minimum of 50 % of the originally
set frequency. After that the frequency increases in steps of 5 % per ON-time until the
originally set frequency is reached again. These frequency variations remain in force during
the complete duration of the treatment.
Advantage: since a constant frequency leads to a relatively rapid exhaustion and diminution
of the muscular activities, such a frequency variations are preventing this, thus ameliorating
the healing effect of the treatment.
)
7.12 Alternating channels ()
A special application of the two channel method with the help of the so called NMES burst
currents, is the treatment using alternating channels, where the current is running
alternatively through the channel A and the channel B.
Advantage: extremely suitable for changing stimulation of the agonistic and the anti
agonistic muscle group, for instance during stabilising exercises. One can also change per
extremity, for instance for alternating stimulation of the left and the right Quadriceps.
7.13 NMES-currents and 4-pole interferential currents graphical representation of the current
In the case of NMES currents the development of these currents is represented graphically.
In such a way one gets a clear picture in what phase the current is at a particular moment.
That way the therapist can guide the patient in an optimal manner through the execution of
the exercises.
In the event of the simultaneous application of 2 NMES currents, the current is only
represented graphically on the intensity screen.
The intensity screen is reached in that case by pressing the Enter
key starting at the
parameter screen.
NOTE:
The evolution of the 4-pole current shapes is also graphically represente d in the lower part of the channel
window.
Above, one can see the dynamic representation of the NMES current shape “Biphasic Burst
current”, where the special option ON2 is set.
COMBI 500 – Operating instructions - version 1.1 – 12/2001
69
8 DIAGNOSTIC PROGRAMS
8.1 Introduction
With the help of the Combi 500 unit the therapist can find out in many different ways to what
degree the electrical irritability of the neuro-muscular system is affected.
The Rheobase, the Chronaxie and the Accommodation Quotient can be measured quite
rapidly.
The recording of a complete S-D curve is also possible; the graph appears on the screen
and it can be stored in memory.
In addition to this the Combi 500 unit offers a number of current shapes that can be utilised
to localise pain points.
NOTE:
This Chapter does not give any explanation about a number of specific topics in relation to the measuring
procedures.
Refer to Chapter 6: GENERAL OPERATING INSTRUCTIONS for more information about the general operation
of the Combi 500 unit.
8.2 Determine Rheobase and Chronaxie
Select Rheobase + Chronaxie
While determining the Rheobase one automatically starts with a rectangular impulse of 1000
ms and an impulse pause of 1000 ms. both parameter conditions cannot be modified. The
intensity is turned open (this is done in steps of 0.1 mÂ) until one detects a barely visible or
sensible contraction.
Leave the intensity regulator in that position and press the Enter key
The Combi 500 unit stores the measured Rheobase in its memory
(see below).
Press the Enter key
As soon as the Rheobase (in mÂ) is determined, the Combi 500 doubles the Rheobase and
the parameters on screen are modified automatically to a pulse time of 0.1 ms. and a pulse
pause of 1000 ms. The parameter Pulse time
reverse image’; one can modify these parameters with the help of the keys
(see below) remains visible in the ‘negative or
and
As soon as one detects a barely sensible or visible contraction, one presses the Enter key
in order to memorize the measured Chronaxie (in ms.).
Press the Enter key
After the measurement procedure, the Result screen is displayed (see below) and these
results can be stored into the memory,
if so desired.
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71
8.3 Determine Rheobase and Accommodation Quotient
The Rheobase is determined as described in the previous paragraph.
Press the Enter key
After saving the Rheobase the Combi 500 unit automatically selects a triangular pulse of
1000 ms and a pause pulse of 1000 ms.
Now, the intensity of the channel A is turned open (this is done in steps of 0.1 mÂ) until a
barely sensible or visible contraction is detected
Leave the intensity regulator in this position and press the key
After this the Combi 500 calculates the Accommodation Quotient and displays it on the
result screen
(see below an example of the result window).
This result window can be stored into the memory if so desired (see Chapter 9: TREATMENT
MEMORY).
8.4 Record S-D curve
An S-D curve can be generated with a rectangular pulse, a triangular pulse or with both at
the same time. The principle of the measurement is the same in the three cases.
Select S-D rectangle + triangle
After the selection of the desired measurement of the S-D curve, there is first an
intermediate screen
(see further), where a certain number of parameters such as the
Recording mode, the Polarity and the Stimulation beep can still be modified.
If the option Recording mode is in the AUTO position, the cursor will automatically jump
from the selected pulse time to the next pulse time to be measured after the measurement.
If the option Recording mode is in the MANUAL position, the cursor also automatically
jumps from the selected pulse time to the next pulse time to be measured afterthe
measurement. However, under MANUAL conditions one still can choose another pulse time.
In that manner one can return if there is doubt in order to repeat a specific measurement, if
necessary.
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Select Start recording S-D curve
When recording the S-D curve one starts with a pulse time of 1000 ms.
After that the pulse time is decreased to the value of 0.1 ms in 17 fixed steps.
As a function of the measurement the screen also displays information about the Rheobase
(Rh), the Chronaxie (Ch), the Accommodation Quotient (AQ) and the optimal pulse time
(OPT).
This window is a results screen, which can be stored in the memory
TREATMENT MEMORY).
(see Chapter 9:
Every once and a while one detects a minimal contraction at a specific pulse time, one
stores the relevant intensity by just pressing the Enter key
(see below).
After that the same procedure must be repeated for the next pulse time.
Press the Enter key
8.4.1 S-D curve – Adjust intensity
When recording an S-D curve with nothing else than a triangular pulse
the next pulse time with an intensity of 0 mÂ,- because a shorter triangle pulse time does
not
always need a higher intensity.
When recording an S-D curve with nothing else than a rectangular pulse,
higher intensity for a shorter pulse time. That is the reason why one always starts here with
the same intensity as the one measured with the previous pulse time.
When recording a combined
measured with the previous rectangular pulse in effect, after changing from the rectangular
to the triangular pulse. When switching over from the triangular pulse to the rectangular
pulse, one starts at the same intensity as the one measured with the previous rectangular
pulse in effect.
S-D curve, one starts at the same intensity as the one
8.5 Storing data in the memory
It is possible to store and save the measurements (Rheobase + Chronaxie, Accommodation
Quotient, S-D-curve) in the memory under a well-determined number.
In the course of time, several curves of the same patient can be saved in order to follow up
and monitor the healing process.
See Chapter 9: TREATMENT MEMORY in order to store data in the program memory.
8.6 Pain points
The Combi 500 unit offers the possibility to diagnose and treat pain points, with the help of
Electrotherapy or Combined therapy (dependant on the predicted localisation of these pain
points. The diagnostic program for pain points Electrotherapy is accessible from the
Electrotherapy menu as well as from the Start menu. In the case of the Combined therapy
the pain points programs are only accessible starting from the Start menu.
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9 TREATMENT MEMORY
9.1 Introduction
The Combi 500 unit has a programmable memory that can be called via the Memory key
. In this menu one can save data for later use and reference.
Often used or specific current shapes for a well-determined patient can be stored in the
memory.
The transfer of treatment data to an observer is also simplified.
Together with the diagnostic programs other data (e.g. an S-D curve) can be stored.
In total there are 500 memory addresses available (memory numbers 500 - 999).
All programs can be stored in an arbitrary order of succession or in other words, the
available memory addresses between the numbers 500 and 999 can be arranged as one
wishes.
9.2 Save Therapy program / Diagnostic program
The saving of a Therapy program or of a Diagnostic program is carried out in an identical
manner.
It is only possible to store a program in the memory if the intensity is at the zero level
further)
screen can be stored in the memory).
(For the programs Rheobase + Chronaxie, AQ and the S-D curves, only the result
• The selections Save and Modify standard program are two options that are not always
visible in the memory display; this is indeed depending on the followed input.
• The option Save is only accessible if one selected the Memory key out of a parameter
window or out of a Results window.
• The option Modify Standard program is only displayed if a standard program was
selected via a direct selection of one of the therapy keys (at the left hand side of the
screen). (Standard programs = program number smaller than 50).
Subsequently the program is linked automatically to the following empty number
number 501).
(see below
Press the Green Key next to 501 in order to
save this free position
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One can browse the memory list with the help of the keys and
With the relevant Green Key, one selects the number under which one wishes to save the
program.
One can save items in an empty address or overwrite an already filled in address.
In the next screen
characters.
(see below) one can store a name and/or a number of maximum 6
The characters are selected with the keys
character, the cursor has to be moved to the next character in order to select that one.
Press the Enter key
If one does not want to fill in a text
is then saved and one leaves the Memory menu. Now, one automatically returns to the
parameter screen and the treatment can start.
An existing program can always be overwritten. There will be a message on screen asking
to confirm the selection once again. In order to confirm one has to press the appropriate
Green Key again.
in order to definitely save the program.
, one can directly press the Enter key . The program
and . Once one detects a searched
Select the characters using the keys
and
Press the Enter key
9.3 Open saved programs
When pressing the Treatment memory key
the stored treatment can be opened in two ways.
The Combi 500 offers a number of System settings, presenting the possibility to adapt the
unit in a very detailed manner to the needs of the user (customer settings).
We recommend having a thorough look at these settings before the first use of the device,
and altering these settings where it is deemed necessary.
Calling up the menu System settings can be carried out as follows: in the screen Start menu
the Return key
running on both channels).
The different menu options will be described successively
must be pressed and held during 3 seconds (there may be no treatment
10.2 Language selection
.
There is a selection of 4 languages: English, German, French and Dutch
of the language).
(see 3.4 for the setting
10.3 Sound
10.3.1 Acoustic signal at the end of treatment
The acoustic signal that one can hear at the end of the set treatment time, can be switched
on or off.
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10.3.2 Acoustic signal when pressing a key
The acoustic signal that one can hear when pressing a key, can be switched on or off.
10.3.3 Sound during ET Stimulation
If the stimulation beep is in the ON position, the start of the stimulus can be accompanied
with an acoustic signal as standard.
10.3.4 Sound volume
To adjust the volume of the acoustic signal.
10.3.5 Beep ET (Electrotherapy) contact
In order to be warned auditively in the event that there is a bad and insufficient contact
between the electrode and the patient’s skin, this parameter must be set to ON.
10.3.6 Beep US (Ultrasound) contact-control
In order to be warned auditively in the event that there is a bad and insufficient contact of
the US head and the patient’s skin, this parameter must be set to ON.
10.3.7 Beep laser power
In order to signal the laser detection of the unit.
10.4 ‘Stand-by’ time
When the Combi 500 unit is not utilised during 10 minutes, it is automatically switched into
the STAND-BY position. The yellow light
will render the device operational again.
If so desired, the Stand-by time can be altered using the System settings.
It is possible to display one’s own text data, e.g. name- or address, in the starting window.
Every time the unit is switched on, these data will be displayed on the starting screen.
Select Text start up screen
The input of the text is self-explanatory.
By means of the keys
When the complete text is filled in, confirm it by pressing the Enter key
and the characters can be set and the cursor can be moved.
10.6 Copying parameters into another channel
If this option is active (ON)
automatically whenever the second channel is selected.
If this option is not active (OFF), you will be transferred automatically to the Start screen if
the second channel is selected. From the start screen one can adjust a therapy
paragraph 7.8 and 7.9).
(see below), the parameters, set for the first channel, will be copied
(see also
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10.7 System information
System information provides information about serial numbers, software versions, last
calibration dates, hardware versions
Always mention the SYSTEMINFO in the event of a FAILURE WARNING to the technical
services; it constitutes a great deal of GAIN OF TIME.
(see below).
10.8 Testing Electrode cables and electrodes
Using the cable and electrode test, one can check the condition of the wiring and the
electrodes.
Tip: check the wiring first, if the cables are in a good condition, proceed to the test of the
electrodes.
10.8.1 Testing Electrode cables
The mode of operation is clearly explained on screen.
The mode of operation is clearly explained on screen.
10.9 Testing Laser probes
In order to arrive at reliable measurements, it is absolutely necessary to carry out the
measurement only in the case that the option Laser therapy has not yet been used on that
very day.
Go to the screen System Settings
Go to the next screen
Select Laser energy measurement
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This measurement is measuring the pulse energy.
Compare the energy per pulse in the channel window with the supplied control report.
If the quadruple probe is tested, one must use yellow protection caps. In this manner one
can test every individual Laser diode. Compare the sum of the four individual energy
measurements with the total energy of the supplied control report.
10.10 Error history
The screen ‘error history’ gives information on the total number of errors registered by your
device during its lifetime. Details over the last 10 errors are also given.
In case of an error message, it is always useful to know these data. Always mention the
system information in the event of a failure warning to the technical services; it constitutes a
great deal of gain of time.
The total number of hours during which the channel for electrotherapy or ultrasound has
been used will be displayed on the screen ‘working hours’. This is the time for which the
amplitude of intensity of the corresponding channel has been higher than 0.
With this screen, you have information on the total number of hours the accessories have
been used.
10.12 Reset working hours
In this screen you can reset the counter for working hours. This may be useful when you
bought new accessories and you want to know the total number of working hours of the
accessories.
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10.13 Restoring standard programs
Here the possibility exists to restore modified standard settings (default) or standard
programs simultaneously to the original standard settings
for the standard settings).
Restore programs 1-50
Press once again to confirm your choice
All
presettings of the modified standard programs have now been changed to their initial
conditions.
NOTE:
The Standard programs are easily recognisable because of their program number between 1 and 50.
Continuous direct current
(Effect: electro-chemical effects leading to an improvement of the blood circulation,
influencing the skin charge and a diminution of the pain awareness).
∗ Superficial circulatory disturbances.
∗ Neuralgia.
∗ Myalgia.
∗ Artralgia.
∗ Bad healing skin injuries (Ulcus cruris, Decubitus).
∗ Bad healing injuries of the soft parts of the bone (chronic tendon lesions, fractures).
∗ As an introducing treatment for electro stimulation (improvement of the electrical
irritability).
∗ As a current shape to apply iontophoresis.
Pulsated rectangular and triangular current
(Effect: in most of the applications monophasic pulses are applied; so see: continuous direct
current effects, further: generation of action potentials at the membrane of the nerve fibres).
∗ See: indication for the continuous direct current.
∗ As current shape for diagnosis in order to detect what the condition is of the peripheral
motor neuron.
∗ As electro stimulation in the case of peripheral paresis.
∗ As electro stimulation for smooth muscular tissue in the event of constipation.
2-5 current - Ultra Reiz current
(Effect: diminution of the pain awareness, improvement of the blood circulation, and
detonisation of the muscular tonus).
Intermediate frequency rectangular current
(Effect: see the effects of the continuous direct current).
∗ See the indications in the case of continuous direct current.
∗ As current shape to apply iontophoresis (advantage: less probability for skin irritation).
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Diadynamic currents
(Effect: improvement of the blood circulation locally superficial as well as intra-muscular,
diminution of the pain awareness, detonisation of the muscular tonus).
∗ Posttraumatic diseases.
∗ Rheumatic diseases.
∗ Superficial circulatory disturbances.
∗ Artralgia (posttraumatic, degenerative).
∗ Neuralgia.
∗ As current shape in order to apply a segmental therapy.
∗ As current shape to detect segmental deregulations (through the examination of the
dermatomes).
TENS current shapes
(Effect: diminution of the pain awareness, improvement of the local, segmental and central
blood circulation, detonisation of the muscular tonus, normalisation of the sympathetic reflex
activity).
∗ Acute and chronic pain (pain in the lower back, headaches, pain in the neck,
dysmenorrhoea, pain in the arms, pain in the legs, phantom pain).
∗ Arthralgia (posttraumatic, degenerative, rheumatic).
∗ Circulatory disturbances.
∗ Post-surgical pains.
∗ Neuralgia.
∗ Myalgia.
∗ Posttraumatic dystrophy (Südeck dystrophy, sympathetic reflex dystrophy).
∗ Active myofascial trigger points.
∗ Actual segmental deregulations.
∗ Disturbed sympathetic reflex activity.
∗ Urgency incontinence.
∗ As current shape to look for active specific stimulus points.
NMES current shapes with low-frequent current
(Effect: improvement of the neuromuscular functions such as the absolute muscular
strength, stamina (endurance), explosive muscular strength, improvement of the activity
daily life (ADL) functions, improvement muscle awareness, decrease spasticity).
∗ Atrophy or imminent atrophy.
∗ Decreased muscular stamina (endurance).
∗ Decreased function of the pelvic floor muscles (stress-incontinence for urine and/or
∗ Circulatory disturbances.
∗ Oedema interstitial tissue.
∗ Cellulites.
∗ Loss of muscle awareness, disturbed locomotive image.
∗ As current shape to improve the activity daily life (ADL): functional electro stimulation
(FES) to improve walking (peroneus stimulator) or stretching.
NMES current shapes with intermediate-frequency current
(Effect: improvement of the neuromuscular functions such as the absolute muscular
strength, stamina (endurance), explosive muscular strength, improvement of the activity
daily life (ADL) functions, improvement muscle awareness, decrease).
∗ Atrophy or imminent atrophy.
∗ Decreased muscular stamina (endurance).
∗ Decreased function of the pelvic floor muscles (stress-incontinence for urine and/or
∗ Circulatory disturbances.
∗ Loss of muscle awareness, disturbed locomotive image. Atrophy or imminent atrophy.
Intermediate-frequency electrotherapy applied by means of interference
(Effect: decreased pain awareness, improvement blood circulation, detonisation of the
muscular tonus, normalisation of the sympathetic reflex activity).
∗ Acute and chronic pain (pain in the lower back, headaches, pain in the neck,
dysmenorrhoea, pain in the arms, pain in the legs, phantom pain).
∗ Arthralgia (posttraumatic, degenerative, rheumatic).
∗ Blood circulation disturbances.
∗ Post-surgical pains.
∗ Neuralgia.
∗ Myalgia.
∗ Posttraumatic dystrophy (Südeck dystrophy, sympathetic reflex dystrophy).
∗ Active myofascial trigger points.
∗ Actual segmental deregulations.
∗ Disturbed sympathetic reflex activity.
∗ Urgency incontinence.
∗ As current shape to look for active specific stimulus points.
Iontophoresis indications
∗ Arthralgia.
∗ Arthritis.
∗ Superficial calcium deposits in soft parts (myositis ossificans, bursitis calcarea, tendinitis
∗ Skin diseases.
∗ Skin infections.
∗ Thrombosis , thromboflebitis.
∗ Varicose.
∗ Increased probability of bleedings.
∗ Superficially implanted materials.
∗ Heart diseases with rhythm disorders (for thoracic applications).
∗ Decreased sensibility.
∗ Around sinus caroticus (deregulation of the nervus vagus).
∗ Menstruation (during the first days abdominal and lumbar).
∗ Pregnancy (during the first days abdominal and lumbar).
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Specific, relative contra-indications:
∗ Skin infections.
∗ Thrombosis, thromboflebitis.
∗ Heart diseases with rhythm disorders (for thoracic applications).
∗ Decreased sensibility.
∗ Around sinus caroticus (deregulation of the nervus vagus).
∗ Pregnancy (during the first days abdominal and lumbar).
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12 INTERFERENCES, WARRANTY, LIABILITY,
SERVICE
12.1 Interferences
A MISTAKE HAS BEEN MADE WHILE OPERATING THE UNIT.
Information is displayed on screen about what exactly is going on. One can repair the
failure oneself by following the instructions on screen.
IT IS IMPOSSIBLE TO SWITCH ON THE COMBI 500 UNIT
keys. In this case the yellow warning light
Check if the mains voltage is present, if the main switch is in the ON position, if the mains
voltage cable is in good condition and finally if no fuses have blown. If the main fuses have
blown, one can replace them by intact ones. Take the power cable out of the mains voltage
wall plug and pull the fuse holder out of the mains voltage switch, if necessary with the aid
of a screwdriver, in order to replace the fuses. Make sure you use the appropriate fuses
that come with the unit exclusively. It is possible to order these fuses at your local Gymna
dealer (type as mentioned on the sticker, affixed next to the mains voltage switch). If it is
still impossible to switch on the Combi 500 unit after having replaced the fuses, please
contact the repair services of your local Gymna dealer.
THE COMBI 500 UNIT DOES NOT REACT TO THE COMMANDS OF THE CONTROLS
and an error message is displayed on screen.
The protective device of the Combi 500 unit has detected an error. It is impossible to
continue the operations. In most of the cases an instruction will be displayed on the screen.
Detach the links to the patient and switch off the unit by means of the mains voltage switch.
Wait for a while and switch back on the appliance. If the error is recurrent, please contact
the repair services of your local Gymna dealer.
There is a FOREIGN LANGUAGE
Set the desired and appropriate language via the menu System settings. If the error is
recurrent, please contact the repair services of your local Gymna dealer.
After having switched on the device, ERROR MESSAGE
the device and switch it back on. Please contact the repair services of your local Gymna
dealer, if the error is recurrent.
on screen.
is not illuminated.
appears on the display. Turn off
when pressing one of the
12.2 Warranty and Liability
12.2.1 Guarantee conditions
The guarantee period for theCOMBI 500 is 1 (one) year, counting from the purchase date
(the date on the purchase invoice counts as evidence). This guarantee covers all defects in
material and workmanship.
The above-mentioned one-year guarantee does not apply in case of repairs of failures or
defects caused by:
− injudicious use of the device;
− an incorrect interpretation of or failure to comply with the directions in this Operating
Instructions;
− negligence or accidents;
− maintenance or repairs by persons not authorised thereto by the manufacturer.
12.2.2 Liability
The manufacturer cannot be held liable for any consequences, either for the therapist, or
for the patient, or for the equipment used, of, for example:
− an incorrect diagnosis;
− improper use of the device or any of its accessories;
− misinterpretation or disregard of the user manual;
− bad maintenance of the device;
− maintenance and/or repairs of the device carried out by persons not authorised
thereto by the manufacturer.
Neither the manufacturer, nor your local Gymna supplier can in any way whatsoever be
held liable, in the event of transfer of infections via the probes or the electrodes.
12.3 Service
GymnaUniphy declares that he is responsible for the proper functioning only when:
− all repairs, modifications, extensions or adjustments have been carried out by
persons authorised thereto;
− the electric installation of the relevant room satisfies the applicable statutory
regulations;
− the device is used by authorised persons according to the instructions in this
Operating Instructions;
− the device is used for the purpose for which it has been designed;
− the maintenance of the device is carried out regularly and in the manner prescribed;
−
See also paragraph 2.7: Technical Control;
− the statutory regulations relating to the use of the device are complied with.
With the exception of the fuses in the mains input there are no components in the device
that can be replaced by the user. Improper use or failure to maintain the device according
to the regulations shall release GymnaUniphy and its representatives from all liability for
any damage, injuries, defects or malfunctioning arising there from.
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Service and guarantee will be provided via your Gymna supplier.
The terms of delivery of your Gymna supplier shall apply.
The guarantee shall lapse when the device is not used in accordance with the above
points.
The expected lifetime of the device is 10 years.
Ten years after having put the Combi 500 device (or any of its accessories) into circulation,
the manufacturer of the device cannot be held liable anymore for not supplying spare parts
or accessories.