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 |
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1.1 |
PURPOSE ...................................................................................... |
7 |
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1.2 |
SAFETY INSTRUCTIONS................................................................... |
7 |
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1.3 |
MEDICAL DEVICES DIRECTIVE ........................................................ |
9 |
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1.4 |
LIABILITY ....................................................................................... |
9 |
2 |
INSTALLATION................................................................................... |
11 |
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2.1 |
RECEIPT ...................................................................................... |
11 |
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2.2 |
PLACING AND CONNECTION .......................................................... |
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2.3 |
PERFORMING THE FUNCTIONAL TEST ............................................ |
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2.4 |
SETTING CONTRAST AND SELECTING LANGUAGE............................ |
11 |
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2.5 |
TRANSPORT AND STORAGE........................................................... |
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2.6 |
RESELLING .................................................................................. |
12 |
3 DESCRIPTION OF THE EQUIPMENT................................................ |
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3.1 |
COMPONENTS OF PULSON 200 .................................................... |
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3.2 |
DISPLAY ...................................................................................... |
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3.3 |
DISPLAY SYMBOLS ....................................................................... |
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3.4 |
PARAMETER SYMBOLS.................................................................. |
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4 |
OPERATION........................................................................................ |
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4.1 |
THERAPY SELECTION.................................................................... |
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4.2 |
SET AND START THERAPY ............................................................ |
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4.3 |
ULTRASOUND THERAPY ................................................................ |
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4.4 |
PROGRAMS.................................................................................. |
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4.5 |
SYSTEM SETTINGS ....................................................................... |
26 |
5 |
INSPECTIONS AND MAINTENANCE ................................................ |
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5.1 |
INSPECTIONS ............................................................................... |
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5.2 |
MAINTENANCE ............................................................................. |
31 |
6 MALFUNCTIONS, SERVICE AND GUARANTEE.............................. |
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6.1 |
MALFUNCTIONS............................................................................ |
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6.2 |
SERVICE...................................................................................... |
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6.3 |
GUARANTEE ................................................................................ |
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6.4 |
TECHNICAL LIFE TIME ................................................................... |
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7 |
TECHNICAL INFORMATION.............................................................. |
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7.1 |
GENERAL..................................................................................... |
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7.2 |
ULTRASOUND THERAPY ................................................................ |
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7.3 |
ENVIRONMENTAL CONDITIONS....................................................... |
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7.4 |
TRANSPORT AND STORAGE........................................................... |
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7.5 |
STANDARD ACCESSORIES............................................................. |
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7.6 |
OPTIONAL ACCESSORIES .............................................................. |
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5 |
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Pulson 200
8 |
APPENDICES...................................................................................... |
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8.1 |
EMC DIRECTIVE........................................................................... |
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8.2 |
TECHNICAL SAFETY INSPECTION ................................................... |
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8.3 |
DISPOSAL .................................................................................... |
47 |
9 |
REFERENCE....................................................................................... |
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9.1 |
TERMINOLOGY ............................................................................. |
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9.2 |
LITERATURE................................................................................. |
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9.3 |
FUNCTION OVERVIEW ................................................................... |
51 |
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9.4 |
INDEX.......................................................................................... |
53 |
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Pulson 200
1SAFETY
1.1Purpose
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.
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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.
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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.
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Pulson 200
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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, 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.
2.4Setting contrast and selecting language
1.Press 
for 5 seconds The System setting menu appears. See §4.5.
2.Press 
next to Contrast, 1st key from the top.
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.
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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.
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Pulson 200
3DESCRIPTION OF THE EQUIPMENT
1
2
3
4
1.Pulson 200. See §3.1.
2.Power cord
3.Contact gel
4.US head
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Pulson 200
3.1Components of Pulson 200
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1. |
Display. See §3.2. |
14.Connector for US head |
2. |
Ultrasound therapy |
15.Indication: Floating patient circuit |
3. |
Memory |
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4. |
Start menu |
16.On/off switch |
5. |
Stop |
17.Connection to mains supply |
6. |
Pause |
18.Type plate |
7. |
Intensity |
19.Ventilation opening |
8. |
Return to previous menu |
20.Fuse holder |
9. |
Enter |
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10.Indication: Read manual 11.Down
12.Up
13.Select parameter or menu
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Pulson 200
3.2 |
Display |
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1. |
Channel |
8. |
Screen for channel A. See |
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2. |
Ultrasound therapy |
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§4.3.2. |
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9. |
Remaining treatment time |
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3. |
Type of US head |
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10.Îset |
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4. |
Title of the screen |
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11.Ppk |
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5. |
Program number |
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12.Contact of the US head |
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6. |
Parameters with selection knobs |
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7. |
Explanation or recommendation |
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Pulson 200
3.3Display symbols
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Ultrasound therapy |
Treatment time |
A |
Channel A |
0:00 Treatment completed |
3.4Parameter symbols
1 10ms 
10%
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2 |
10ms |
20% |
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310ms 30%
410ms 40%
510ms 50%
100%
US duty cycle 10%
US duty cycle 20%
US duty cycle 30%
US duty cycle 40%
US duty cycle 50%
US duty cycle 100%
set
Ppk
W/cm2
Set US intensity
Peak US output power
Unit of the set US intensity
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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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