The Pulson 200 is intended solely for medical applications. You can use the
Pulson 200 for ultrasoundtherapy. 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 'Medical Devices Directive' 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
Pulson 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.
1.2.4Electro Magnetic Compatibility
•Medical electrical equipment requires special precautions
for Electro Magnetic Compatibility (EMC). Follow the
instructions for the installation of the equipment. See §2.
•Do not use mobile telephones or other radio, shortwave,
or microwave equipment in the vicinity of the equipment.
This kind of equipment can cause disturbances.
•Only use the accompanying accessories that are supplied
by GymnaUniphy. See §7.6.
Other accessories can lead to an increased emission or a
reduced immunity.
1.2.5Ultrasound 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.
8
Pulson 200
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.
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 by accessories.
9
Pulson 200
10
Pulson 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.
•Inform your supplier of any damage or defects by no later than within
3 working days after receipt. Report the damage by telephone, fax, email 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.
2.4Setting contrast and selecting language
1. Press for 5 seconds The System setting menu appears. See §4.5.
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
Pulson 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
Pulson 200
3DESCRIPTION OF THE EQUIPMENT
1
2
4
1. Pulson 200. See §3.1.
2. Power cord
3. Contact gel
4. US head
3
13
Pulson 200
3.1Components of Pulson 200
1
2
3
4
596
1. Display. See §3.2.
2. Ultrasound therapy
14 15
16 17 1819
13
12
11
10
!
7
8
20
14.Connector for US head
15.Indication: Floating patient circuit
3. Memory
4. Start menu
5. Stop
6. Pause
7. Intensity
8. Return to previous menu
9. Enter
10.Indication: Read manual
11.Down
12.Up
13.Select parameter or menu
16.On/off switch
17.Connection to mains supply
18.Type plate
19.Ventilation opening
20.Fuse holder
14
3.2Display
Pulson 200
8
9
10
11
12
1234
.
TENS
frequency
frequency
time
15:00
set
red+
0
.
0
0
0
US+Conv
Pulse time
CV
.
0
Pulseform
Min.
Max.
Sweepmode
Treatment
Perceptibe, comfortable
7
40 s
80
100
15:00
5
34
Hz
6
Hz
1. Channel
2. Ultrasound therapy
3. Type of US head
4. Title of the screen
5. Program number
6. Parameters with selection knobs
7. Explanation or recommendation
8. Screen for channel A. See
§4.3.2.
9. Remaining treatment time
10.Îset
11.Ppk
12.Contact of the US head
15
3.3Display symbols
Ultrasound therapyTreatment time
Pulson 200
A
Channel ATreatment completed
3.4Parameter symbols
1
10ms
2
10ms
3
10ms
4
10ms
5
10ms
US duty cycle 10%Set US intensity
10%
US duty cycle 20%Peak US output power
20%
US duty cycle 30%
30%
US duty cycle 40%
40%
US duty cycle 50%
50%
US duty cycle 100%
100%
W
0:00
set
P
pk
cm
/
Unit of the set US
2
intensity
16
Pulson 200
4OPERATION
4.1Therapy selection
You can select a therapy in different ways, with the therapy key or with the
parameters in the Start menu:
•Therapy key: Quickly select a therapy with the therapy key . 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. See §4.1.5.
•Contra-indications: Display an overview with contra-indications for the
ultrasound therapy. See §4.1.6.
Besides this, you can change the system settings. See §4.5.
4.1.1Therapy key
Press : Ultrasound therapy. The
Ultrasound screen appears.
4.1.2Therapy selection via objectives
1. Press to go to the start menu.
2. Select Objectives.
3. Select the desired treatment with
.
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Pulson 200
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 §9.3.4.
4. Select the desired indication with
.
•US: Ultrasound 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 §9.3.
4. Press .
See §4.4.
4.1.5Diagnostic program selection
With the diagnostic programs, you can search for stress fractures.
1. Press to go to the start menu.
2. Select Diagnostic programs.
3. Select Stress fracture search
with .
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Pulson 200
4.1.6Contra indication selection
1. Press to go to the start menu.
2. Select Contra indications.
19
Pulson 200
4.2Set 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.
Set the Treatment time as follows:
Press once on to set the
minutes, press twice on to
set the seconds.
4. 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.
5. Rotate intensity knob to start the treatment and to set the desired
intensity. The set intensity is displayed in the screen.
4.2.1Opening the intensity screen
1. Set the treatment. See §4.2.
2. Rotate intensity knob to start the
treatment.
3. Press . The intensity screen
appears.
4. Press to return to the setting
menu.
4.2.2Temporary interruption of treatment
1. Press during the treatment. The treatment time of the selected
channel is stopped. Pause appears on the screen. The parameter
settings are retained.
2. Press on again to restart the treatment. The intensity now increases
gradually to the set level and the treatment time continues again.
4.2.3Immediately 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.
20
Pulson 200
4.3Ultrasound therapy
4.3.1Performing ultrasound therapy
Move the US head evenly over the skin during the treatment.
This prevents internal burns.
1. Plug the connector of the US head
into the connector of the
Pulson 200.
2. Select the desired ultrasound
therapy. With some treatments,
the parameter Head placement
refers to the number in the placing
diagrams.
3. Apply contact gel to the skin to be
treated and to the US head.
4. Place the head on the skin.
5. Rotate intensity knob to start the ultrasound therapy.
6. Move the US head evenly over the skin during the treatment. This
prevents internal burns.
7. Check the patient's reaction and the effect of the treatment. Repeat this
check regularly during the treatment.
8. The equipment stops the treatment and indicates that the treatment is
completed.
4.3.2Read-out values
1. Channel
123
2. Ultrasound therapy
3. Type of US head
4. Remaining treatment time
5. Îset
6. Ppk
4
5
6
7. Contact of the US head
7
21
Pulson 200
Contact of US head
The contact of the US head with the skin:
•: Bad contact, US head switched off (0 W).
•: Bad contact.
•: Sufficient contact.
•: Good contact.
•: Very good contact
Test the US head if its conduction is bad. See §5.1.1.
Îset (W/cm
The power (W) of the US head per cm².
Ppk (W)
The peak power of the US head (Îset * ERA). The peak power delivered
therefore depends on the size of the US head and the contact with the skin.
This value is 0.0 W if the contact with the skin is bad. In this case, the
ultrasound treatment of the equipment is stopped to prevent overheating of
the transducer.
2
)
4.3.3Parameters
Treatment time (mm:ss)
The duration of the treatment.
Duty cycle (10, 20, 30, 50%, continuous)
Ratio of the pulse duration to the period duration.
•Continuous: Continuous ultrasound (100%).
•10, 20, 30, 50%: Pulsating ultrasound.
Select a high duty cycle for an intensive treatment. Select a low duty cycle
for a mild treatment.
ERA (cm2)
The effective radiating area expressed in cm² of the treatment head
connected. This area equals the cross-sectional area of the beam at the
treatment surface. The ERA depends on the frequency. This parameter
remains empty if no US head is connected.
Head placement
Instructions for placing the US head. Consult the placement diagrams.
22
Pulson 200
US frequency (MHz)
The frequency of the US head. The absorption at a US frequency of 3 MHz
is three times higher and the penetration depth is three times less than at a
US frequency of 1 MHz. Use 3 MHz for superficial tissue and 1 MHz for
deeper tissue.
23
Pulson 200
4.4Programs
You can save 20 of your own programs for later use: programs 500 up to
and including 519. You can modify these programs for much-used settings
for a certain patient.
4.4.1Saving a program
1. Select a therapy. See §4.1.
2. Change the settings for the
patient. See §4.2.
3. Press .
4. Select Save,
5. Select a free program number
with .
If desired, go to the following
programs with or .
6. Enter the name of the program.
Use the name or the number of
the patient, for example.
•Select a character with and
.
•Select Cursor to left/right to
move the cursor.
7. Press to save the program.
4.4.2Selecting a saved program
4.4.2.1Selecting a program by the name list
1. Press .
2. Select Open by name list.
3. Go to the desired program with
or .
4. Select this program with .
24
Pulson 200
4.4.2.2Selecting a program by the number
1. Press .
2. Select Open by number.
3. Select the desired program with
or .
4. Press .
4.4.3Clear a program
1. Press .
2. Select Clear program.
3. Select the program that must be
deleted with .
If desired, go to the following
programs with or .
4. Press to clear the program.
4.4.4Editing a standard program
Standard programs have a program
number that is lower than 50. You can
only edit standard programs with the
therapy key.
1. Select a program with the therapy
key .
2. Press .
3. Select Change default program.
4. Press to edit the
standardprogram.
You can also save an edited standard program under a free program
number. See §4.4.1.
You can reset the standard settings of the standard programs with Reset Menu. See §4.5.2.
25
Pulson 200
4.5System settings
With the system settings, you can adapt the Standard settings of the
equipment. You cannot change the system settings during a therapy.
4.5.1Changing the system settings
1. Press for 5 seconds. The
screen appears with the system
settings.
2. Change the desired
systemsetting. See §4.2.
4.5.2Parameters
Contrast (1 - 20)
The contrast of the display.
Language
The language selection: select the language with which the read-out must
work.
Sound settings
Sound settings. See §4.5.3.
Text start up screen
The text that appears in the top of the start up screen, after the equipment
is switched on. See §4.5.4.
System information
System information of the equipment
Always have this information available when you contact the technical
service department.
Error history
The total number of error reports that the equipment has had and details
about the last 10 error reports.
Always have this information available when you contact the technical
service department.
26
Pulson 200
Reset menu
•Reset working hours: Set the number of working hours of an US head to
zero.
•Reset programs 1-50: This restores the standard settings of the standard
programs. See §4.4.4.
•Erase total memory: Restores the standard settings of the standard
programs and of the edited programs.
Press again to confirm.
Stopping time with bad US contact
On: The treatment stops during a bad contact of the US head.
Counter working hours (hours, minutes, sec.)
The time that the accessories for ultrasound therapy have been in use. For
this, the output of the channel must have been higher than zero.
4.5.3Setting the sound
1. Press for 5 seconds.
2. Select Sound settings,
3. Change the desired sound setting.
See §4.2.
End of treatment
On: A sound signal will be heard at the end of the treatment.
Pressing a key
On: A sound signal will be heard every time a key is pressed.
Beep volume (min.1, standard 5, max.10)
The volume of the sound signals.
US bad contact
On: A sound signal will be heard if the US head does not make good contact
with the skin.
27
Pulson 200
4.5.4Set text for start up screen
You can set your own text for the start up screen. For example, you can put
your name or address information here.
1. Press for 5 seconds, select
Text start up screen.
2. Enter the name for the start up
screen.
•Select a character with and
.
•Select Cursor to left/right to
move the cursor.
3. Press to confirm the name.
28
Pulson 200
5INSPECTIONS AND MAINTENANCE
5.1Inspections
ComponentCheckFrequency
US headDents, cracks or other damageAt least 1x per
month
Test US head See §5.1.1.With bad operation
or at least 1x per
year
Cable of US headDamage
Pins in connector straight
EquipmentTechnical safety inspection.
See §5.1.2.
At least 1x per
month
At least 1x per year
5.1.1US head test
Test the US head if its conduction is bad. This is the case when the
indication bar for the Ppk value displays or .
1. Select an ultrasound therapy.
2. Place the US head in a bowl with water.
3. Rotate intensity knob to start the treatment.
4. Check in the screen of the channel to see if the Ppk value is increasing.
5. Contact your local GymnaUniphy dealer if the indication bar still displays
or .
5.1.2Technical safety inspection
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. If the legislation in your country or your
insurer prescribes a shorter period, you must adhere to this shorter period.
•Only a technician authorised by GymnaUniphy N.V. may
open the equipment or the accessories.
•The inspection may only be performed by a suitably
qualified person. In some countries this means that the
person must be accredited.
5.1.2.1Inspection points
The technical safety inspection contains the following tests:
1. Test 1: General: Visual inspection and check on the operating functions
2. Test 2: Ultrasound therapy
3. Test 3: Electrical safety inspection: measurement of the earth leakage
current and patient leakage current according to DIN/VDE 0751-1
ed. 2.0.
29
Pulson 200
5.1.2.2Inspection result
A registration must be maintained of the technical safety inspections. Use
the inspection report in the appendix for this purpose. See §8.2. Copy this
appendix. Complete the copied appendix. Keep the inspection reports for at
least 10 years.
The inspection is successful if all inspection items are passed.
Repair all faults on the equipment before the equipment is put back into
operation.
By comparing the registred measurement values with previous
measurements, a possible slowly-deteriorating deviation can be
ascertained.
30
Pulson 200
5.2Maintenance
ComponentMaintenanceFrequency
US headCleaning. See §5.2.1.After each use
Accessories that come in contact with the body of the patient
must be washed with pure water after the disinfection to
prevent allergic reactions.
5.2.1Cleaning the US head
1. Clean the US head with a lightly moistened soft cloth.
2. Disinfect the treatment surface with a cotton bud that is soaked in a
10% HAC solution.
3. Rinse the US head thoroughly with clean water.
31
Pulson 200
32
Pulson 200
6MALFUNCTIONS, SERVICE AND GUARANTEE
6.1Malfunctions
ComponentProblemSolution
Pulson 200Equipment cannot be
switched on
Equipment does not react to
commands or a fault report
appears
Foreign language on the
screen
See §6.1.1.
See §6.1.3.
Change the language. See
§4.5.2.
6.1.1Equipment cannot be switched on
1. Check if the mains voltage has failed.
2. Check if the main switch is switched on (“I”).
3. Check if the power cord and the fuses are in order. If necessary, replace
the fuse. See §6.1.2.
4. Contact your dealer if the equipment still cannot be switched on.
6.1.2Replacing a fuse
1. Switch the main switch off (“O”).
2. Unplug the power cord from the equipment.
3. Pull the fuse holder carefully out of the equipment. If necessary, use a
screwdriver.
4. Replace the fuse. Only use the fuses supplied. If necessary, order new
fuses from your dealer.
5. Install the fuse holder and plug in the power cord.
6. Switch the main switch on again (“I”).
6.1.3Equipment does not react to commands or an error
message appears
The safety system of the equipment has ascertained a fault. You cannot
continue to work. An instruction usually appears on the screen.
1. Disconnect the connection to the patient.
2. Switch the main switch off (“O”).
3. Wait 5 seconds and switch the main switch on again (“I”).
4. Contact your dealer if the error message reappears.
33
Pulson 200
6.2Service
•Only a technician authorised by GymnaUniphy N.V. may
open the equipment or the accessories to perform
repairs. The equipment does not contain any components
that may be replaced by the user.
•If possible, open the screen with the system settings
before you contact the technical service department. See
§4.5.
Service and guarantee are provided by your local GymnaUniphy dealer. The
conditions of delivery of your local GymnaUniphy dealer apply.
If you have qualified technical personnel that are authorised by
GymnaUniphy to perform repairs, your dealer can provide diagrams, spare
parts lists, calibration instructions, spare parts and other information on
request, for a fee.
6.3Guarantee
GymnaUniphy and the local GymnaUniphy dealer declares itself to be solely
responsible for the correct operation when:
•all repairs, modifications, extensions or adjustments are performed by
authorised people;
•the electrical installation of the relevant area meets the applicable legal
regulations;
•the equipment is only used by suitably qualified people, according to
these user instructions;
•the equipment is used for the purpose for which it is designed;
•maintenance of the device is regularly performed in the way prescribed.
See §5.;
•the technical life time of the equipment and the accessories is not
exceeded;
•the legal regulations with regard to the use of the equipment have been
observed.
The guarantee period for the equipment is 1 (one) year, beginning on the
date of purchase. The date on the purchase invoice acts as proof. This
guarantee covers all material and production faults. Consumables do not fall
under this guarantee period.
34
Pulson 200
This guarantee does not apply to the repair of defects that are caused:
•by incorrect use of the equipment,
•by an incorrect interpretation or not accurately following these user
instructions,
•by carelessness or misuse,
•as a consequence of maintenance or repairs performed by people or
organisations that are not authorised to do so by the manufacturer.
6.4Technical life time
The expected life time of the equipment is 10 years, calculated from the
date of manufacture. See the type plate for this information.
In so far as possible, GymnaUniphy will supply service, spare parts and
accessories for a period of 10 years from the date of manufacture.
35
Pulson 200
36
Pulson 200
7TECHNICAL INFORMATION
7.1General
Dimensions Pulson 200 (w x h x d)266 x 275 x 100 mm
Weight Pulson 2003,650 kg
Weight including accessories4,6 kg
Mains voltage100 - 240 VAC, 50-60 Hz
Maximum power, in operation85 VA
Safety classClass I (earthed socket required)
InsulationType BF (floating patient circuit)
Fuses2 x T2AL250V
Accuracy of intensity± 10% of maximum at set values
above 10% of this maximum
Treatment time0 - 30 min.
Deviation of time clock< 0,5%
Modulation frequency100 Hz
Modulation typeCW (rectangular on/off)
Repetition period of pulses10 ms
7.2.2Modulation and pulse duration
Modulation duty cycle 1005040302010%
Pulse time
Ratio of p
f
- p122,50 3,33510
tm
5 4 3 2 1 ms
37
Pulson 200
7.2.3US heads
US head, model 204
Acoustic operating frequency1,13,2MHz
Output power8,19,5W
Effective intensity of output voltage2,02,0W/cm²
Effective Radiating Area (ERA) 4,14,7cm²
Beam Non-uniform Ratio (BNR)4,55,8
Maximum intensity of beam 9,011,7W/cm²
Beam type
US head, model 201
Acoustic operating frequency1,13,2MHz
Output power3,82,8W
Effective intensity of output voltage2,02,0W/cm²
Effective Radiating Area (ERA) 1,91,4cm²
Beam Non-uniform Ratio (BNR)5,23,3
Maximum intensity of beam 10,56,6W/cm²
Beam type
CollimatingCollimating
CollimatingCollimating
7.3Environmental conditions
Temperature:+10 °C to +40 °C
Relative humidity30% to 75%
Atmospheric pressure700 hPa to 1060 hPa
7.4Transport and storage
Transport weight5.5 kg
Storage temperature-20 °C to +60 °C
Relative humidity10% to 100%, including
condensation
Atmospheric pressure200 hPa to 1060 hPa
Transport classificationSingle pieces, by post
The transport and storage specifications apply to equipment in the original
packaging.
38
Pulson 200
7.5Standard accessories
QuantityDescriptionArt. no.
1US head, 1/3 MHz - ERA 4 cm²
117.122
incl. holder
1Contact gel, 150 ml100.018
1Power cord*100.689
1User instructions
NL: 117.124
FR: 117.125
EN: 117.126
DE: 117.127
1US placing diagrams117.128
*) This power cord has a CEE 7/7 type plug. For countries with other outlets, a
different power cord with the appropriate plug is supplied.
7.6Optional accessories
DescriptionArt. no.
US head, multi-frequency,1/3 MHz - ERA 1 cm²
117.123
incl. holder
Contact gel, bottle 500 ml100.016
Contact gel, can 5 l100.019
Pump for can, 5 l100.020
Article numbers can change in the course of time. Check the article numbers in the
most recent catalogue or ask your dealer.
The drawings are merely indicative, no rights can be derived from them.
39
Pulson 200
40
Pulson 200
8APPENDICES
8.1EMC directive
Use only US heads that are specified in this manual. See §7. The use of
other accessories can have a negative effect on the electromagnetic
compatibility of the equipment.
If you use the Pulson 200 in the vicinity of other equipment, you must
check that the Pulson 200 is functioning normally.
The following paragraphs contain information about the EMC properties of
the equipment.
8.1.1Guidance and declarations
Guidance and manufacturer’s declaration - electromagnetic emissions
The 200-series devices are intended for use in the electromagnetic
environment specified below. The custumer or the user of a 200-series
device should assure that it is used in such an environment.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Group 1
Class B
Class B
Complies
Therefore, their RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
200-series devices are suitable
The
for use in all establishments, including
domestic establishments and those
directly connected to the public lowvoltage power supply network that
supplies buildings used for domestic
purposes.
41
Pulson 200
Guidance and manufacturer’s declaration - electromagnetic immunity
The 200-series devices are intended for use in the electromagnetic environment specified
below.The custumer or the user of a 200-series device should assure that it is used in
such an environment.
Immunity testIEC 60601
test level
Electrostatic
Discharge
±6 kV contact
±8 kV air
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
±2 kV for power
supply lines
±1 kV for input/
IEC 61000-4-4
Surge
output lines
±1 kV differential
mode
IEC 61000-4-5
±2 kV common
mode
Voltage dips,
short interruptions and voltage variations
on power supply input lines
IEC 61000-4-11
<5% U
dip in U
(>95%
T
for 0,5
T
cycle
40% UT (60% dip
in U
for 5 cycles
T
70% U
in U
(30% dip
T
for 25
T
cycles
<5% UT (>95%
dip in U
for 5
T
sec
Power
3 A/mNot
frequency
(50/60 Hz)
magnetic field
Compliance
level
±6 kV
contact /
±8 kV air
No loss of
performance
±2 kV power
/ ±1 kV I/O
No loss of
performance
±1 kV diff. /
±2 kV
comm.
No loss of
performance
U
- 100%
T
(0,5 period)
No loss of
performance
U
- 60%
T
(5 periods)
No loss of
performance
U
- 30%
T
(25 periods)
No loss of
performance
U
- 100%
T
(5 seconds)
Device
resets to a
safe state.
(60601-1
§ 49.2)
applicable
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
must be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of a 200-series
device requires continued operation during
power mains interruptions, it is
recommended that the 200-series device
be powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
IEC 61000-4-8
NOTEU
is the a.c. mains voltage prior to application of the test level
T
42
Pulson 200
Guidance and manufacturer’s declaration - electromagnetic immunity
The 200-series devices are intended for use in the electromagnetic environment specified
below.The custumer or the user of a 200-series device should assure that it is used in
such an environment.
Immunity testIEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of a 200-series device, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz - 80 MHz
3 V/m
80 MHz - 2,5 GHz
[V
[E
] V
1
] V/m
1
35
d
-------- -
V
P=
1
80 MHz to 800 MHz:
35
d
-------- -
E
P=
1
800 MHz to 2,5 GHz:
7
d
----- -
E
P=
1
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey
compliance level in each frequency range
Interference may occur in the vicinity of
equipment marked with the following symbol:
a
, should be less than the
b
.
.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 The guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
and mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey can be considered. If the measured field strength in the location in which a
200-series device is used exceeds the applicable RF compliance level above, the 200-series devices
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the 200-series device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths must be less than [V1] V/m.
43
Pulson 200
Recommended separation distances between portable and mobile RF
communications equipment and the 200-series device
The 200-series device is intended for use in the electromagnetic environment in which
radiated RF disturbances are contolled. The custumer or the user of a 200-series device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the 200series devices as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2,5 GHz
35
d
-------- -
V
1
P=
d
35
-------- -
E
1
P=
d
7
----- -
E
P=
1
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
44
Pulson 200
8.2Technical safety inspection
Pulson 200 with serial number ............. is / is not1 in good working
order
Inspection performed
Owner:
by:
Location:Name:Name:
Date:Initials:Initials:
1
Cross out what does not apply.
If a specific test does not apply to this equipment, place a mark in the NA
(not applicable) column.
8.2.1Test 1: General
YesNoNA
1. The results of earlier safety inspections are
available.
2. The logbook is present.
3. The type plate and the supplier's label are legible.
4. The housing, adjusting knobs, keys and display are
undamaged.
5. The power connection and power cord are
undamaged.
6. The output connectors are undamaged.
7. The cables and connectors of the US head(s) are
undamaged.
8. The US head(s) do not display any cracks or other
damage that can endanger the insulation.
9. The automatic self-test at switch-on does not give
an error message.
10.The display does not show any defective points or
lines.
45
Pulson 200
8.2.2Test 2: Ultrasound
1. Connect the treatment head and place it in an ultrasound
measurement device. Press to select the
ultrasoundtherapy.
2. Select 1 MHz, continuous (duty cycle 100%), 2 W/cm²
The measured value is within ±20% of the Ppk value in the
channel window.
3. Select 1 MHz, duty cycle 50%, 3 W/cm²
The measured value is within ±20% of half the Ppk value
in the channel window.
4. Select 3 MHz, continuous (duty cycle 100%), 2 W/cm²
The measured value is within ±20% of the Ppk value in the
channel window.
YesNo
5. Select 3 MHz, duty cycle 50%, 3 W/cm²
The measured value is ±20% of half the Ppk value in the
channel window.
6. Select 3 MHz, duty cycle 50%, 0.5 W/cm²
With a dry treatment surface, the Ppk value becomes 0.
7. Select 1 MHz, duty cycle 50%, 0.5 W/cm²
With a dry treatment surface, the Ppk value becomes 0.
The maximum power transfer takes place at the operating frequencies. If the
equipment does not function at the correct frequency, this results in a too low
output power. It is therefore not necesary to check the operating frequencies.
8.2.3Test 3: Electrical safety test (VDE 0751)
YesNo
1. The resistance of the safety earth is less than 0.2
2. The housing leakage current is less than 1000 µA
:
3. The patient leakage current is less than 5000 µA
Notes:
46
Pulson 200
8.3Disposal
Take account of the following environmental aspects when disposing of the
equipment and the accessories:
•The basic device en the cables fall under small chemical waste (or
electronic waste). These components contain lead, tin, copper, iron,
various other metals and various plastics, etc. Consult the applicable
national regulations.
•Gels contain only organic material and do not require any special
processing.
•Packaging materials and manuals can be recycled. Deliver them to the
appropriate collection points or include them with the normal household
waste. This depends on the local organisation of the waste processing.
47
Pulson 200
48
Pulson 200
9REFERENCE
9.1Terminology
trophic: The state of nourishment.
9.2Literature
A literature list can be sent on request. Please contact GymnaUniphiphy.
49
Pulson 200
50
Pulson 200
9.3Function overview
9.3.1Therapy key
The numbers refer to the program numbers.
Ultrasound therapy
Ultrasound therapy......................31
9.3.2System settings
Press for 5 seconds
Contrast
Language
Sound settings
Text start up screen
System information
Error history
Counter working hours
Reset menu
Stopping time if bad US
9.3.3Objectives
The numbers refer to the program numbers.
Ultrasound therapy
Trophic condition
Tendinitis
Subacute ........................... 63
Chronic.............................. 62
Ligament lesions
Subacute ........................... 64
Chronic............................ 144
Muscle lesions
Subacute ........................... 64
Chronic............................ 144
Osteo-chondral lesions......... 144
Neurogenic lesions................. 64
Increase extensibilty
Superficial contracture ........... 65
Part. joint contracture .......... 145
Improve cell function
Acute joint lesions ................. 66
Acute muscular lesions.......... 66
Acute neurogenic lesions ...... 66
Fracture healing ..................... 67
9.3.4Indications
US: Ultrasound therapy
The numbers refer to the program numbers.
Arthrosis, US
Subacute ................................ 64
Chronic.................................144
Bechterew, US ........................... 62
Bursitis, US ................................62
Contractures, US
Superficial .............................. 65
Deep ...................................... 62
Decubitus, US............................ 88
Dupuytren, US........................... 65
51
Pulson 200
Epicondylitis, US
Subacute ................................ 63
Chronic................................... 62
Fractures, US .............................67
Frozen shoulder, US................145
Myalgia, US..............................144
Neuropathy, US.........................66
Posttraum. diseases, US
Acute...................................... 66
Subacute ................................ 64
9.3.5Diagnostics
Stress fracture search ...............112
9.3.6Contra indications
Ultrasound therapy
General
High fever
Severe cardiovascular problems
Psychological problems
Cancer with tumor metastasis
Generalised tuberculosis
Scar tissue, US
Acute ..................................... 66
Subacute................................ 65
Sprain, US
Acute ..................................... 66
Subacute................................ 64
Tendinitis, US
Subacute................................ 63
Chronic................................... 62
Ulcus Cruris, US ........................ 88
Specific relative for pulsing
ultrasound
Pacemaker
Pregnancy
Specific relative for continuous
ultrasound
Infections
Acute inflammations
Thrombosis, thrombophlebitis
Varices
Increased risk to haemorrhage
Pacemaker
Epiphyseal disc (children)
Decreased sensibility
Menses
Cement of endoprosthesis
Diabetes mellitus
52
9.4Index
Pulson 200
A
Accessories 39
C
Cellular function improvement 51
Change default program 25
Cleaning 31
Condition trophic 51
Connection 11
Contra indication
selecting 19
Contra indications 52
Contrast 11, 26
Counter working hours 27
D
Diagnostic program
selecting 18
Diagnostics 52
Directive on Medical Devices 9
Display 15
symbols 16
Disposal 47
Duty cycle 22
E
Elasticity improvement 51
Electrical safety 8
EMC 8
EMC directive 41
ERA 22
Error history 26