GymnaUniphy Pulson 200 User manual

User Manual
PULSON 200
Pulson 200
ABBREVIATIONS
EMC Electromagnetic Compatibility ESD Electrostatic Discharge HAC Hospital Antiseptic Concentrate US Ultrasound
SYMBOLS ON THE EQUIPMENT
Read the manual.
SYMBOLS IN THE MANUAL
Warning or important information.
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Pulson 200
TABLE OF CONTENTS
1 SAFETY................................................................................................. 7
1.1 P
1.2 S
1.3 M
1.4 L
URPOSE ...................................................................................... 7
AFETY INSTRUCTIONS................................................................... 7
EDICAL DEVICES DIRECTIVE ........................................................ 9
IABILITY ....................................................................................... 9
2 INSTALLATION................................................................................... 11
2.1 R
2.2 P
2.3 P
2.4 S
2.5 T
2.6 R
ECEIPT ...................................................................................... 11
LACING AND CONNECTION .......................................................... 11
ERFORMING THE FUNCTIONAL TEST ............................................ 11
ETTING CONTRAST AND SELECTING LANGUAGE............................ 11
RANSPORT AND STORAGE........................................................... 12
ESELLING .................................................................................. 12
3 DESCRIPTION OF THE EQUIPMENT ................................................ 13
3.1 C
3.2 D
3.3 D
3.4 P
OMPONENTS OF PULSON 200 .................................................... 14
ISPLAY ...................................................................................... 15
ISPLAY SYMBOLS ....................................................................... 16
ARAMETER SYMBOLS.................................................................. 16
4 OPERATION........................................................................................ 17
4.1 T
4.2 S
4.3 U
4.4 P
4.5 S
HERAPY SELECTION.................................................................... 17
ET AND START THERAPY ............................................................ 20
LTRASOUND THERAPY ................................................................ 21
ROGRAMS.................................................................................. 24
YSTEM SETTINGS ....................................................................... 26
5 INSPECTIONS AND MAINTENANCE ................................................ 29
5.1 I
5.2 M
NSPECTIONS ............................................................................... 29
AINTENANCE ............................................................................. 31
6 MALFUNCTIONS, SERVICE AND GUARANTEE .............................. 33
6.1 M
6.2 S
6.3 G
6.4 T
ALFUNCTIONS............................................................................ 33
ERVICE...................................................................................... 34
UARANTEE ................................................................................ 34
ECHNICAL LIFE TIME ................................................................... 35
7 TECHNICAL INFORMATION .............................................................. 37
7.1 G
7.2 U
7.3 E
7.4 T
7.5 S
7.6 O
ENERAL..................................................................................... 37
LTRASOUND THERAPY ................................................................ 37
NVIRONMENTAL CONDITIONS....................................................... 38
RANSPORT AND STORAGE........................................................... 38
TANDARD ACCESSORIES............................................................. 39
PTIONAL ACCESSORIES .............................................................. 39
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8 APPENDICES...................................................................................... 41
8.1 EMC
8.2 T
8.3 D
DIRECTIVE........................................................................... 41
ECHNICAL SAFETY INSPECTION ................................................... 45
ISPOSAL .................................................................................... 47
9 REFERENCE....................................................................................... 49
9.1 T
9.2 L
9.3 F
9.4 I
ERMINOLOGY ............................................................................. 49
ITERATURE................................................................................. 49
UNCTION OVERVIEW ................................................................... 51
NDEX .......................................................................................... 53
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Pulson 200
1SAFETY
1.1 Purpose
The Pulson 200 is intended solely for medical applications. You can use the Pulson 200 for ultrasoundtherapy. The device is suited for continuous use.
1.2 Safety instructions
1.2.1 General
Only qualified people who are trained in the application of the therapies may use the appliance.
Only a technician authorised by GymnaUniphy N.V. may open the equipment or the accessories.
Follow the instructions and directions in these user instructions.
Place the 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.
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Pulson 200
1.2.2 Electrical 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.
1.2.3 Prevention 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.
1.2.4 Electro 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.
1.2.5 Ultrasound 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.
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1.3 Medical Devices Directive
The device complies with the essential requirements of the Medical Device Directive of the European Committee (93/42/EEC) as most recently changed.
1.4 Liability
The manufacturer cannot be held liable for injury to the therapist, the patient or third parties, or for damage to or by the equipment used, if for example:
an incorrect diagnosis is made;
the equipment or the accessories are used incorrectly;
the user instructions are wrongly interpreted or ignored;
the equipment is badly maintained;
maintenance or repairs are performed by people or organisations that are not authorised to do so by GymnaUniphy.
Neither the manufacturer nor the local GymnaUniphy dealer can be held liable, in any way whatsoever, for the transfer of infections by accessories.
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2INSTALLATION
2.1 Receipt
1. Check whether the equipment has been damaged during transport.
2. Check whether the accessories are intact and complete. See §7.6.
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.
2.2 Placing 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.
2.3 Performing the functional test
1. Switch the equipment on with the switch at the rear of the equipment.
2. When the equipment is switched on, it automatically performs a test.
2.4 Setting 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.
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2.5 Transport and storage
Take account of the following matters if the equipment has to be transported or stored:
Transport or store the equipment in the original packaging.
The maximum period for transport or storage is: 15 weeks.
Temperature: -20 °C to +60 °C.
Relative humidity: 10% to 100%.
Atmospheric pressure: 200 hPa to 1060 hPa.
2.6 Reselling
This medical equipment must be traceable. The equipment, the US head and some other accessories have a unique serial number. Provide the dealer with the name and address of the new owner.
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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
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3.1 Components of Pulson 200
1
2
3 4
596
1. Display. See §3.2.
2. Ultrasound therapy
14 15
16 17 18 19
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
3.2 Display
Pulson 200
8
9 10 11 12
123 4
.
TENS
frequency
frequency
time
15:00
set
red+
0
.
0
0
0
US+Conv
Pulse time
CV
.
0
Pulse form
Min.
Max.
Sweep mode
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
3.3 Display symbols
Ultrasound therapy Treatment time
Pulson 200
A
Channel A Treatment completed
3.4 Parameter 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
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Pulson 200
4OPERATION
4.1 Therapy 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.
4.1.1 Therapy key
Press : Ultrasound therapy. The Ultrasound screen appears.
4.1.2 Therapy selection via objectives
1. Press to go to the start menu.
2. Select Objectives.
3. Select the desired treatment with
.
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4.1.3 Therapy 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
4.1.4 Program 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.
4.1.5 Diagnostic 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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4.1.6 Contra indication selection
1. Press to go to the start menu.
2. Select Contra indications.
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4.2 Set 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.
4.2.1 Opening 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.
4.2.2 Temporary 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.
4.2.3 Immediately 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.
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4.3 Ultrasound therapy
4.3.1 Performing 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.
4.3.2 Read-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
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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
)
4.3.3 Parameters
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.
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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.
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4.4 Programs
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.
4.4.1 Saving 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.
4.4.2 Selecting a saved program
4.4.2.1 Selecting 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 .
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4.4.2.2 Selecting a program by the number
1. Press .
2. Select Open by number.
3. Select the desired program with
or .
4. Press .
4.4.3 Clear 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.
4.4.4 Editing 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.
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4.5 System settings
With the system settings, you can adapt the Standard settings of the equipment. You cannot change the system settings during a therapy.
4.5.1 Changing the system settings
1. Press for 5 seconds. The screen appears with the system settings.
2. Change the desired systemsetting. See §4.2.
4.5.2 Parameters
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.
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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.
4.5.3 Setting 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.
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Pulson 200
4.5.4 Set 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.
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Pulson 200
5INSPECTIONS AND MAINTENANCE
5.1 Inspections
Component Check Frequency
US head Dents, cracks or other damage At least 1x per
month
Test US head See §5.1.1. With bad operation
or at least 1x per year
Cable of US head Damage
Pins in connector straight
Equipment Technical safety inspection.
See §5.1.2.
At least 1x per month
At least 1x per year
5.1.1 US 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 .
5.1.2 Technical 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.
5.1.2.1 Inspection 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.
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5.1.2.2 Inspection 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.
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Pulson 200
5.2 Maintenance
Component Maintenance Frequency
US head Cleaning. 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.
5.2.1 Cleaning 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.
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6MALFUNCTIONS, SERVICE AND GUARANTEE
6.1 Malfunctions
Component Problem Solution
Pulson 200 Equipment 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.
6.1.1 Equipment 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.
6.1.2 Replacing 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”).
6.1.3 Equipment 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.
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Pulson 200
6.2 Service
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.
6.3 Guarantee
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.
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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.
6.4 Technical 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.
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Pulson 200
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Pulson 200
7TECHNICAL INFORMATION
7.1 General
Dimensions Pulson 200 (w x h x d) 266 x 275 x 100 mm Weight Pulson 200 3,650 kg Weight including accessories 4,6 kg Mains voltage 100 - 240 VAC, 50-60 Hz Maximum power, in operation 85 VA Safety class Class I (earthed socket required) Insulation Type BF (floating patient circuit) Fuses 2 x T2AL250V
7.2 Ultrasound therapy
7.2.1 General
Insulation classification Type BF Peak power 0 - 2 W/cm², duty cycle = 100%
0 - 3 W/cm², duty cycle < 100%
Accuracy of intensity ± 10% of maximum at set values
above 10% of this maximum Treatment time 0 - 30 min. Deviation of time clock < 0,5% Modulation frequency 100 Hz Modulation type CW (rectangular on/off) Repetition period of pulses 10 ms
7.2.2 Modulation and pulse duration
Modulation duty cycle 100 50 40 30 20 10 %
Pulse time Ratio of p
f
- p 1 2 2,50 3,33 5 10
tm
5 4 3 2 1 ms
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7.2.3 US heads
US head, model 204
Acoustic operating frequency 1,1 3,2 MHz
Output power 8,1 9,5 W Effective intensity of output voltage 2,0 2,0 W/cm² Effective Radiating Area (ERA) 4,1 4,7 cm² Beam Non-uniform Ratio (BNR) 4,5 5,8 Maximum intensity of beam 9,0 11,7 W/cm² Beam type
US head, model 201
Acoustic operating frequency 1,1 3,2 MHz
Output power 3,8 2,8 W Effective intensity of output voltage 2,0 2,0 W/cm² Effective Radiating Area (ERA) 1,9 1,4 cm² Beam Non-uniform Ratio (BNR) 5,2 3,3 Maximum intensity of beam 10,5 6,6 W/cm² Beam type
Collimating Collimating
Collimating Collimating
7.3 Environmental conditions
Temperature: +10 °C to +40 °C Relative humidity 30% to 75% Atmospheric pressure 700 hPa to 1060 hPa
7.4 Transport and storage
Transport weight 5.5 kg Storage temperature -20 °C to +60 °C Relative humidity 10% to 100%, including
condensation Atmospheric pressure 200 hPa to 1060 hPa Transport classification Single pieces, by post
The transport and storage specifications apply to equipment in the original packaging.
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Pulson 200
7.5 Standard accessories
Quantity Description Art. no.
1 US head, 1/3 MHz - ERA 4 cm²
117.122
incl. holder
1 Contact gel, 150 ml 100.018
1 Power cord* 100.689
1 User instructions
NL: 117.124 FR: 117.125 EN: 117.126 DE: 117.127
1 US placing diagrams 117.128
*) 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.
7.6 Optional accessories
Description Art. no.
US head, multi-frequency,1/3 MHz - ERA 1 cm²
117.123
incl. holder Contact gel, bottle 500 ml 100.016
Contact gel, can 5 l 100.019
Pump for can, 5 l 100.020
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.
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Pulson 200
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Pulson 200
8APPENDICES
8.1 EMC 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.
8.1.1 Guidance 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.
Emission test Compliance Electromagnetic environment - guidance
200-series devices use RF
The energy only for their internal function.
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-3
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.
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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 test IEC 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/m Not 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 NOTE U
is the a.c. mains voltage prior to application of the test level
T
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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 test IEC 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.
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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 MHz 80 MHz to 800 MHz 800 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.
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Pulson 200
8.2 Technical 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.
8.2.1 Test 1: General
Yes No NA
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.
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Pulson 200
8.2.2 Test 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.
Yes No
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.
8.2.3 Test 3: Electrical safety test (VDE 0751)
Yes No
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:
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Pulson 200
8.3 Disposal
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.
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Pulson 200
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Pulson 200
9REFERENCE
9.1 Terminology
trophic: The state of nourishment.
9.2 Literature
A literature list can be sent on request. Please contact GymnaUniphiphy.
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Pulson 200
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Pulson 200
9.3 Function overview
9.3.1 Therapy key
The numbers refer to the program numbers.
Ultrasound therapy
Ultrasound therapy......................31
9.3.2 System 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
9.3.3 Objectives
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
9.3.4 Indications
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
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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
9.3.5 Diagnostics
Stress fracture search ...............112
9.3.6 Contra 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
9.4 Index
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
F
Function overview 51 Functional test 11
G
Guarantee 34
I
Indications 18, 51 Inspection 29 Installation 11 Intensity screen 20 Interruption 20 Îset 22
L
Language 11, 26 Liability 9 Literature 49
M
Maintenance 31 Malfunctions 33
N
Name list 24
O
Objectives 17, 51
P
Placement 11
US head 22 Ppk 22 Prevention of explosion 8 Program 24
clear 25
number selection 18
saving 24
selecting 24 Purpose 7
R
Replacing a fuse 33 Reselling 12 Reset menu 27
S
Safety 7 Select therapy 17 Service 34 Sound settings 26
set 27 Stop 20 Stop treatment 20 Storage 12
conditions 38 System settings 26
changing 26
T
Technical information 37 Technical life time 35
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Pulson 200
Technical safety inspection 29, 45 Terminology 49 Text start up screen 26
set 28
Therapy
direct selection 17 program selection 18 selecting 17, 20 selection via indication list 18
start 20 Therapy key 51 Transport 12
conditions 38 Treatment
interruption 20
stop 20 Treatment time 22 Trophic 49
U
Ultrasound therapy 21
parameters 22
perform 21
read-out values 21
safety 8 US frequency 23 US head
cleaning 31
contact 22
test 29
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Pulson 200
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Pulson 200
56
Pasweg 6A B-3740 Bilzen
Tel.: (+32) (0) 89/510.510 Fax: (+32) (0) 89/510.511
www.gymna-uniphy.com E-mail: info@gymna-uniphy.com
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