Gymna PULSON 200 User Manual
User Manual
PULSON 200
Pulson 200
4
ABBREVIATIONS
EMC Electromagnetic Compatibility
ESD Electrostatic Discharge
HAC Hospital Antiseptic Concentrate
US Ultrasound
SYMBOLS ON THE EQUIPMENT
SYMBOLS IN THE MANUAL
Read the manual.
Warning or important information.
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TABLE OF CONTENTS
1 SAFETY................................................................................................. 7
1.1 P
URPOSE ...................................................................................... 7
1.2 S
AFETY INSTRUCTIONS................................................................... 7
1.3 M
EDICAL DEVICES DIRECTIVE ........................................................ 9
1.4 L
IABILITY ....................................................................................... 9
2 INSTALLATION................................................................................... 11
2.1 R
ECEIPT ...................................................................................... 11
2.2 P
LACING AND CONNECTION .......................................................... 11
2.3 P
ERFORMING THE FUNCTIONAL TEST ............................................ 11
2.4 S
ETTING CONTRAST AND SELECTING LANGUAGE............................ 11
2.5 T
RANSPORT AND STORAGE........................................................... 12
2.6 R
ESELLING .................................................................................. 12
3 DESCRIPTION OF THE EQUIPMENT ................................................ 13
3.1 C
OMPONENTS OF PULSON 200 .................................................... 14
3.2 D
ISPLAY ...................................................................................... 15
3.3 D
ISPLAY SYMBOLS ....................................................................... 16
3.4 P
ARAMETER SYMBOLS.................................................................. 16
4 OPERATION........................................................................................ 17
4.1 T
HERAPY SELECTION.................................................................... 17
4.2 S
ET AND START THERAPY ............................................................ 20
4.3 U
LTRASOUND THERAPY ................................................................ 21
4.4 P
ROGRAMS.................................................................................. 24
4.5 S
YSTEM SETTINGS ....................................................................... 26
5 INSPECTIONS AND MAINTENANCE ................................................ 29
5.1 I
NSPECTIONS ............................................................................... 29
5.2 M
AINTENANCE ............................................................................. 31
6 MALFUNCTIONS, SERVICE AND GUARANTEE .............................. 33
6.1 M
ALFUNCTIONS............................................................................ 33
6.2 S
ERVICE...................................................................................... 34
6.3 G
UARANTEE ................................................................................ 34
6.4 T
ECHNICAL LIFE TIME ................................................................... 35
7 TECHNICAL INFORMATION .............................................................. 37
7.1 G
ENERAL..................................................................................... 37
7.2 U
LTRASOUND THERAPY ................................................................ 37
7.3 E
NVIRONMENTAL CONDITIONS....................................................... 38
7.4 T
RANSPORT AND STORAGE........................................................... 38
7.5 S
TANDARD ACCESSORIES............................................................. 39
7.6 O
PTIONAL ACCESSORIES .............................................................. 39
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8 APPENDICES...................................................................................... 41
8.1 EMC
DIRECTIVE........................................................................... 41
8.2 T
ECHNICAL SAFETY INSPECTION ................................................... 45
8.3 D
ISPOSAL .................................................................................... 47
9 REFERENCE....................................................................................... 49
9.1 T
ERMINOLOGY ............................................................................. 49
9.2 L
ITERATURE................................................................................. 49
9.3 F
UNCTION OVERVIEW ................................................................... 51
9.4 I
NDEX .......................................................................................... 53
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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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1.2.2 Electrical safety
1.2.3 Prevention of explosion
1.2.4 Electro Magnetic Compatibility
1.2.5 Ultrasound therapy
• 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.
• Do not use the equipment in an area where combustible
gases or vapours are present.
• Switch off the equipment when it is not used.
• 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.
• 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
st
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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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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3DESCRIPTION OF THE EQUIPMENT
1. Pulson 200. See §3.1.
2. Power cord
3. Contact gel
4. US head
3
2
1
4
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3.1 Components of Pulson 200
1. Display. See §3.2.
2. Ultrasound therapy
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
14.Connector for US head
15.Indication: Floating patient circuit
16.On/off switch
17.Connection to mains supply
18.Type plate
19.Ventilation opening
20.Fuse holder
!
2
3
4
596
7
8
1
12
13
11
10
14 15
16 17 18 19
20
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3.2 Display
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
Pulse time
40 s
US+Conv
.
TENS
34
Pulse form
Min.
frequency
frequency
Max.
80
100
Hz
Hz
Sweep mode
Treatment
time
15:00
15:00
red+
0
CV
set
0
0
0
0
.
.
Perceptibe, comfortable
123 4
5
6
7
8
9
11
10
12
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3.3 Display symbols
3.4 Parameter symbols
Ultrasound therapy Treatment time
Channel A Treatment completed
US duty cycle 10% Set US intensity
US duty cycle 20% Peak US output power
US duty cycle 30%
Unit of the set US
intensity
US duty cycle 40%
US duty cycle 50%
US duty cycle 100%
A
0:00
1
10ms
10%
set
2
10ms
20%
pk
P
3
10ms
30%
W
cm
2
/
4
10ms
40%
5
10ms
50%
100%
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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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