AQAccomodation Quotient
CCConstant Current
COCombination therapy
CPCourte Période
CVConstant Voltage
DFDiphasé Fixe
ELElectrode
EMCElectromagnetic Compatibility
ESDElectrostatic Discharge
ETElectrotherapy
HACHospital Antiseptic Concentrate
LPLongue Période
MFMedium Frequency: with unidirectional and interferential currents
Monophasé Fixe: with diadynamic currents
MTPMyofascial Trigger Point
NMESNeuro Muscular Electro Stimulation
TENSTranscutaneous Electrical Nerve Stimulation
USUltrasound
VASVisual Analogue Scale
The Combi 200 is intended solely for medical applications. You can use the
Combi 200 for electrotherapy, ultrasound therapy and combination therapy.
The device is suited for continuous use.
1.2Safety instructions
1.2.1General
• Only qualified people who are trained in the application of the
therapies may use the appliance.
• Only a technician authorised by GymnaUniphy N.V. may open
the equipment or the accessories.
• Follow the instructions and directions in these user
instructions.
• Place the equipment on a horizontal and stable base.
• Keep the ventilation openings at the bottom and rear of the
equipment free.
• Do not place any objects on the equipment.
• Do not place the equipment in the sun or above a heat source.
• Do not use the equipment in a damp area.
• Do not let any liquid flow into the equipment.
• Do not disinfect or sterilise the equipment. Clean the
equipment with a dry or moistened cloth. See §5.
• Only treat patients with electrical implants (pacemaker) after
obtaining medical advice.
• The 'Directive on Medical Devices' from the European
Commission (93/42/EEG) requires that safe devices are used.
It is recommended to perform a yearly technical safety
inspection. See §5.1.2.
• For optimum treatment, a patient investigation must first be
performed. On the basis of the findings of the investigation, a
treatment plan with objectives will be formulated. Follow the
treatment plan during the therapy. This will limit possible risks,
related to the treatment, to a minimum.
• Always keep these user instructions with the equipment.
7
Combi 200
1.2.2Electrical safety
• Only use the equipment in an area with facilities that meet the
applicable legal regulations.
• Connect the equipment to an outlet with a protective earth
terminal. The outlet must meet the locally applicable
requirements for medical areas.
1.2.3Prevention of explosion
• Do not use the equipment in an area where combustible
gases or vapours are present.
• Switch off the equipment when it is not used.
1.2.4Electromagnetic Compatibility
• Medical electrical equipment requires special precautions for
Electro Magnetic Compatibility (EMC). Follow the instructions
for the installation of the equipment. See §2
• Do not use mobile telephones or other radio, shortwave, or
microwave equipment in the vicinity of the equipment. This
kind of equipment can cause disturbances.
• Only use the accompanying accessories that are supplied by
GymnaUniphy. See §7.6, §7.7 and §7.8.
Other accessories can lead to an increased emission or a
reduced immunity.
8
1.2.5Electrotherapy
• Do not use the equipment simultaneously with high frequency
surgical equipment. This combination can cause burning of
the skin under the electrodes.
• Do not use adhesive electrodes with currents that have a
galvanic component, such as galvanic, diadynamic, MF
rectangular, pulsed rectangular and triangular currents. With
these currents, etching of the skin can occur.
• Check the electrode cables and the electrodes at least once a
month. Check whether the insulation is still intact. See §5.1.
• The safety standards for electrical stimulation advise not to
exceed the current density of 2.0 mA
However, with iontophoresis treatments, we advise a
maximum current density of 0.25 mÂ/cm
the MF rectangular current. Exceeding this value can result in
skin irritation and burns.
• Always use sterilised gauze with iontophoresis treatments.
1.2.6Ultrasound therapy
• Move the US head evenly over the skin during the treatment.
This prevents internal burns.
• The US treatment heads are exchangeable. The device
detects the characteristics and supplies the right power at the
right frequency.
• Handle the US heads carefully. With rough handling, the
characteristics can change. Test the US head if it falls on the
ground or knocks against something. See §5.1.1.
• Check the US head at least once a month. During the check,
look for dents, cracks and other damage that could allow
liquids to ingress. Check whether the insulation of the cable is
still intact. Check whether all pins are present and straight in
the connectors. Replace the US head if the head, the cable or
the connector is damaged. See §5.1.
Combi 200
/cm2.
rms
2
, because of using
1.3Medical Devices Directive
The device complies with the essential requirements of the Medical Device
Directive of the European Committee (93/42/EEC) as most recently
changed.
9
Combi 200
1.4Liability
The manufacturer cannot be held liable for injury to the therapist, the
patient or third parties, or for damage to or by the equipment used, if for
example:
•an incorrect diagnosis is made;
•the equipment or the accessories are used incorrectly;
•the user instructions are wrongly interpreted or ignored;
•the equipment is badly maintained;
•maintenance or repairs are performed by people or organisations that
are not authorised to do so by GymnaUniphy.
Neither the manufacturer nor the local GymnaUniphy dealer can be held
liable, in any way whatsoever, for the transfer of infections via the vaginal,
anal and rectal probes and/or other accessories.
10
Combi 200
2INSTALLATION
2.1Receipt
1.Check whether the equipment has been damaged during transport.
2.Check whether the accessories are intact and complete. See §7.6, §7.7 and §7.8.
•Inform your supplier of any damage or defects by no later than
within 3 working days after receipt. Report the damage by
telephone, fax, e-mail or letter.
•Do not use the equipment if it is damaged or defective.
2.2Placing and connection
1.Place the equipment on a horizontal and stable base.
•Keep the ventilation openings at the bottom and rear of the
equipment free.
•Do not place the equipment in the sun or above a heat source.
•Do not use the equipment in a wet area.
2.Check whether the mains voltage that is stated on the rear of the
equipment corresponds with the voltage of your mains supply. The
equipment is suited for a nominal mains voltage from 100 V to 240 VAC
/ 50-60 Hz.
3.Connect the device to an outlet with protective earth terminal.
2.3Performing the functional test
1.Switch the equipment on with the switch at the rear of the equipment.
2.When the equipment is switched on, it automatically performs a test.
Check whether the indicator lamps next to and light briefly
during the test.
3.If the lamps do not light up: See §6.
A
B
2.4Setting contrast and selecting language
1.Press for 5 seconds. The System setting menu appears. See §4.8.
2.Press next to Contrast, 1
3.If necessary, change the contrast with and .
4.Press next to Language.
5.If necessary, change the language with and .
6.Press to return to the start menu.
st
key from the top.
11
Combi 200
2.5Transport and storage
Take account of the following matters if the equipment has to be
transported or stored:
•Transport or store the equipment in the original packaging.
•The maximum period for transport or storage is: 15 weeks.
•Temperature: -20 °C to +60 °C.
•Relative humidity: 10% to 100%.
•Atmospheric pressure: 200 hPa to 1060 hPa.
2.6Reselling
This medical equipment must be traceable. The equipment, the US head
and some other accessories have a unique serial number. Provide the
dealer with the name and address of the new owner.
12
Combi 200
3DESCRIPTIONOFTHEEQUIPMENT
3.1Combi 200 and standard accessories
10
9
8
76
1.Combi 200. See §3.2.
2.Power cord
3.Contact gel
4.US head
5.VAS score card
6.Elastic fixation straps (4 pieces)
1
54
7.EL sponges for rubber
electrode (4 pieces)
8.Rubber electrodes (4 pieces)
9.Two-ply electrode cable (2
pieces)
10. Test connector
2
3
13
Combi 200
3.2Components of Combi 200
1
2
3
4
5
6
7
A
B
AB
8139101112
1.Display. See §3.3.
2.Electrotherapy
3.Ultrasound therapy
4.Combination therapy
5.Memory
6.Start menu
7.Channel selection: A or B
8.Stop
9.Intensity of channel A
10. Pause
11. Return to previous menu
12. Intensity of channel B
13. Enter
14. Indication: Read manual
15. Down
16. Up
18
17
19 21 2223
16
15
14
!
20
A
242627
2528
B
17. Select parameter or menu
18. Connector for US head
19. On/off switch
20. Fuse holder
21. Connection to mains supply
22. Type plate
23. Ventilation opening
24. Connector for electrotherapy,
channel A
25. Indicator lamp for channel A
26. Indication: Floating patient
circuit
27. Connector for electrotherapy,
channel B
28. Indicator lamp for channel B
14
3.3Display
Combi 200
1234
10
11
9
12
13
1.Channel
2.Therapy
3.Current shape
4.Title of the screen
5.Program number
6.Parameters with selection
knobs
7.Use to go to the next
parameters
15:00
set
red+
0
.
0
0
0
.
0
US+Conv
Pulse time
Pulseform
CV
Min.
Max.
Sweepmode
Treatment
Perceptibe, comfortable
5
.
TENS
frequency
frequency
time
8
8.Explanation or recommendation
9.Screen for channel A (here,
electrotherapy). See §4.3.5.
10. Remaining treatment time
11. Polarity
12. Set intensity
13. Screen for channel B (here,
ultrasound therapy). See §4.4.2.
40 s
80
100
15:00
Hz
Hz
34
6
7
15
3.4Display symbols
3.4.1General
Combi 200
SEQ
ElectrotherapyChannel A
Ultrasound therapyChannel B
Combination therapy
Sequential current
shapes
A
B
A + B
0:00
Channel A and B
simultaneously
Treat me nt tim e
Treatment completed
3.4.2Current shape groups
Unidirectional currents2-pole medium frequency
Diadynamic4-pole Interferential
TENS currents
NMES currentsDiagnostic programs
4-pole interferential with
vector
3.5Symbols for current shapes in memory menu
Medium frequency
unidirectional current
Unidirectional rectangular
current
Unidirectional triangular
current
Conventional TENSBiphasic surge current
Low frequency TENS
Random TENS
16
Burst TENS
Rectangular surge
current
Triangular surge current
Intrapulse interval surge
current
2-pole medium frequency
surge current
Combi 200
CP
DF
LP
MF
CP (diadynamic)2-pole medium frequency
DF (diadynamic)
LP (diadynamic)Rheobase and chronaxie
MF (diadynamic)Rheobase and AQ
3.6Parameter symbols
3.6.1Electrotherapy
Red+
Red-
+
Sweep mode
Polarity indicationConstant Current
Alternating polarityConstant Voltage
-
Biphasic pulse shape,
symmetrical
Biphasic pulse shape,
asymmetrical
CHR
AQ
CC
CV
mA
V
4-pole interferential with
rotating vector
mA peak
Volt peak
12
12
6
12s/12s1s/5s -1s/5s
6
6s/6s1s/1s
3.6.2Ultrasound therapy
1
2
3
4
5
10ms
10ms
10ms
10ms
10ms
US duty cycle 10%US duty cycle 100%
10%100%
US duty cycle 20%Set US intensity
20%
US duty cycle 30%Peak US output power
30%
US duty cycle 40%
40%
US duty cycle 50%
50%
11
W cm
17
5
5
1
1
set
P
pk
Unit of the set US
2
/
intensity
Combi 200
3.7Current shapes
3.7.1Unidirectional currents
Rectangular pulse currentTriangular pulse current
2-5 current (UltraReiz)
5 ms
2 ms
3.7.2Diadynamic currents
MFCP
DFLP
3.7.3Interferential currents
2-pole medium frequency
4-pole Interferential
3.7.4TENS currents
Conventional TENS,
asymmetrical
Conventional TENS,
alternating asymmetrical
Conventional TENS,
symmetrical
Medium frequency
rectangular current
DF
MF
DF
MF
4-pole interferential with
rotating vector
Conventional TENS,
alternating symmetrical
TENS burst
TENS burst, alternating
3.7.5NMES currents
Rectangular surge
current
Triangular surge current
Medium frequency surge
current (2- and 4-pole)
Biphasic surge current
Intrapulse interval surge
current
18
Combi 200
4OPERATION
4.1Therapy selection
You can select a therapy in different ways, with the therapy keys or with the
parameters in the Start menu:
•Therapy keys: Quickly select a therapy with therapy keys , and .
See §4.1.1.
•Objectives: Select a therapy on the basis of an objective. See §4.1.2.
•Indication list: Select a therapy on the basis of a medical indication.
See §4.1.3.
•Program number: Select a certain program number or a program
number that you previously saved. See §4.1.4.
•Diagnostic programs: Perform a diagnosis, for example to determine
the rheobase and the chronaxie. See §4.1.5.
•Contra indications: Display an overview with contra indications for the
different therapies. See §4.1.6.
Besides this, you can change the system settings. See §4.8.
4.1.1Therapy keys
Electrotherapy, direct selection
1.Press : Electrotherapy.
2.Select the current shape group
with .
3.Select the current shape with
.
Ultrasound therapy, direct selection
1.Press : Ultrasound therapy. The Ultrasound screen appears.
Combination therapy, direct selection
1.Press : Combination therapy.
2.Select the current shape with . See §4.5.1.
19
Combi 200
4.1.2Therapy selection via objectives
1.Press to go to the start menu.
2.Select Objectives.
3.Select Electrotherapy or
Ultrasound therapy.
4.Select the desired treatment
with .
4.1.3Therapy selection via indication list
1.Press to go to the start menu.
2.Select Indication list.
3.Go to the following indications
with or . See §9.1.4.
4.Select the desired indication
with .
•ET: Electrotherapy
•US: Ultrasound therapy
•CO: Combination therapy
4.1.4Program number selection
1.Press to go to the start menu.
2.Select Program number.
3.Select the desired program with
or . See §9.1.
4.Press . See §4.7.
20
Combi 200
4.1.5Diagnostic program selection
With the diagnostic programs, you can localise and treat pain points, and
look for stress fractures, etc.
1.Press to go to the start menu.
2.Select Diagnostic programs.
3.Select the desired diagnosis
with . See §4.6.
4.1.6Contra indication selection
1.Press to go to the start menu.
2.Select Contra indications.
3.Select the therapy for which you
want to see the contra
indications.
21
Combi 200
4.2Performing therapy
4.2.1Set and start therapy
1.Press to go to the start menu.
2.Select the desired menu with
until the treatment appears.
3.Select the desired parameters
with . You can only change the
outlined parameters.
4.Set the Treatment time as
follows: Press once on to set
the minutes, press twice on
to set the seconds.
5.Change the value of the parameter
with and . The setting range of the parameter is shown at the
bottom of the screen. You can change the parameter as long as the
parameter has a black background.
6.Rotate intensity knob A or B to start the treatment and to set the
desired intensity. The set intensity is displayed in the screen.
4.2.2Set channels A and B
The Combi 200 has two separated electrotherapy channels A and B. The
only restriction is that both are in the CC mode or the CV mode.
The channels A and B can be used independently. You can treat two
different indications simultaneously with two different treatments.
1.Press for 5 seconds. The System setting menu appears. See §4.8.
2.If necessary, change the parameter Copy parameters to OFF.
3.The selected channel has a black background. If desired, press to
A
B
change the first channel.
4.Select a treatment. See §4.1.
5.Set the parameters for the first channel. See §4.2.1.
6.Press to select the other channel.
A
B
7.Select a treatment for the second channel. See §4.1.
8.Set the parameters for the second channel. See §4.2.1.
Both channels are selected simultaneously and automatically in case of:
•4-pole current shapes
•Combination therapy
22
Combi 200
Copy channel
On the second channel, you can set the same parameters for
electrotherapy as for the first set channel.
1.Press for 5 seconds. The System setting menu appears. See §4.8.
2.If necessary, change the parameter Copy parameters to ON.
3.Select a treatment. See §4.1.
4.Set the parameters for the first channel. See §4.2.1.
5.Press to select the other channel. The treatment including the
A
B
settings are copied to the other channel.
6.If desired you can change the parameters or the treatment of the
selected channel.
Clear channel
1.Make sure that the intensity is set to zero.
2.Press to select the channel that you want to clear.
A
B
3.Press . The channel is cleared.
4.2.3Opening the intensity screen
1.Set the treatment. See §4.2.1.
2.Rotate intensity knob A or B to
start the treatment.
3.Press . The intensity screen
appears.
The left part of the screen
shows channel A. The right part
of the screen shows channel B.
4.Press to return to the setting
menu.
4.2.4Temporary interruption of treatment
1.If the other channel has to pause: Select this channel with .
2.Press during the treatment. The treatment time of the selected
channel is stopped. Pause appears on the screen. The parameter
settings are retained.
3.Press on again to restart the treatment. The intensity now increases
gradually to the set level and the treatment time continues again.
A
B
4.2.5Immediately stop treatment
1.Press . All active treatments are stopped immediately. Stop appears
on the screen. The parameter settings are retained.
2.Set the intensity of the channel again to continue the treatment.
23
Combi 200
4.3Electrotherapy
4.3.1Performing electrotherapy with electrodes
1.Select the desired electrotherapy program.
2.Place the electrodes. See page 24: Placing rubber electrodes and page 25: Placing the adhesive electrodes. With some treatments, the
Electrode placing parameter refers to the number in the placing
diagrams.
3.Rotate intensity knob A or B to start the electrotherapy and to set the
desired intensity. See §4.1.2.
4.Check the patient's reaction. Repeat this check regularly during the
treatment.
5.The equipment stops the treatment and indicates that the treatment is
completed. Remove the electrodes.
Placing rubber electrodes
1.Moisten two EL sponges. Use
water with a saline solution to
improve the conductivity of the EL
sponges.
2.Slide a rubber electrode into each
sponge.
3.Place the sponges on the part of
the body that must be treated.
4.Fasten the sponges to the part of
the body with the elastic fixation
straps.
5.Connect the rubber electrode with the red connector to the red
connector of the two-ply electrode cable.
6.Connect the rubber electrode with the black connector to the black
connector of the two-ply electrode cable.
7.Connect the two-ply cable to connector or of the Combi 200.
A
B
24
Combi 200
Placing the adhesive electrodes
Do not use adhesive electrodes with currents that have a
galvanic component, such as galvanic, diadynamic, MF
rectangular, pulsed rectangular and triangular currents.
These currents can cause skin etching.
1.If possible, disinfect the parts of
the body where the adhesive
electrodes are to be placed.
2.Place the electrodes on the part of
the body that must be treated.
3.Connect the connectors of the
adhesive electrodes to the adapter
cables.
4.Connect the adapter cables to the
two-ply electrode cable.
5.Connect the two-ply electrode
cable to connector or of the Combi 200.
A
B
4.3.2Perform electrotherapy with vaginal, anal or rectal
stimulation probe
• Considering the very personal and intimate character of these
treatments, a probe may only be used for one patient.
• Never disinfect the probes in an autoclave. The probes can be
damaged by the extreme temperature.
1.Clean the probe carefully with
soap and water.
2.Select the desired electrotherapy
program.
25
Combi 200
3.Connect the probe to the Combi 200. The vaginal and anal probes are
immediately detected by the equipment. To prevent unpleasant
stimulations, you can only set alternating currents with a Constant
Voltage (CV) setting, such as TENS, NMES, and 2-pole interferential
currents.
The rectal stimulation probe is not detected by the equipment.
With a rectal stimulation probe, select only alternating currents
with a Constant Voltage (CV) setting, such as TENS, NMES, and
2-pole interferential currents. This prevents skin etching and
unpleasant stimulations.
4.Apply an antiseptic lubricant to the probe.
5.Place the probe.
6.Rotate intensity knob A or B to start the treatment and to set the
desired intensity.
7.Check the patient's reaction. Repeat this check regularly during the
treatment.
8.The equipment stops the treatment and indicates that the treatment is
completed. Remove the stimulation probe.
9.Clean the stimulation probe. See §5.2.4.
4.3.3Electrotherapy with sequential steps
A treatment with sequential steps consists of a succession of the same
current form, but additional with different parameter settings. You can set
the time between the steps.
Advantages
Electrotherapy with sequential steps has several advantages:
•In one electrotherapy, you can realise several objectives.
•In a treatment with one objective, you can place different accents in the
objective.
•You can distinguish between different phases in a treatment, for
example preparation, core effect and cooling.
Set new intensity between sequential steps
The intensity determines the peak value during the treatment. When
changing to a following step, the intensity is retained if safety allows.
Sometimes, it is necessary to increase the intensity for the following step.
If the intensity cannot be maintained for safety reasons, the intensity
returns to zero. In this case, the treatment is stopped. You must now set
the intensity again.
26
Combi 200
Setting a treatment with sequential steps
1.Select a treatment whereby you
can set sequential steps, for
example with Objectives,
Electrotherapy, Muscular
training, Specific muscle
functions, Endurance.
You can also select a program
directly with the program number.
2.Set the Step time and
Stimulation beep parameters for
the different steps.
Select Seq. step. nr. to select a different step.
3.Rotate intensity knob A or B to start the treatment and to set the
desired intensity.
Skip step in treatment
1.Press to temporarily interrupt the treatment.
2.Select Seq. step nr. and select the desired step.
3.Rotate intensity knob A or B to continue the treatment again and to set
the desired intensity.
4.3.4Performing iontophoresis
1.Apply the medicament on a sterile gauze. See §8.1. Care must be taken
in administering medicaments (allergies, contra indications, ... ).
2.Place the gauze on the electrode. Make sure that the polarity
corresponds with the medicament used.
3.Place the electrodes. See page 24: Placing rubber electrodes and page
25: Placing the adhesive electrodes.
4.Select Electrotherapy, Unidirectional, Medium freq. constant.
5.Set the intensity between 0.1 and 0.25 mÂ/cm
depends on the surface area of the electrodes. With electrodes of
6x8cm (=48cm
2
), the current setting must be between 4.8 and 12
mÂ.
2
. The intensity
To prevent etching or burns, never exceed 0.25 mÂ/cm2.
27
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