Gymna Pulson 100 User manual

Pulson 100
User Manual
Pasweg 6A
B-3740 Bilzen
Tel.: (+32) (0) 89/510.510
Fax: (+32) (0) 89/510.511
www.gymna-uniphy.com
E-mail: [e-mail]
Your dealer:
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© 2007, GymnaUniphy N.V.
All rights reserved. Nothing from this publication may be copied, stored in
an automated data file, or made public, in any form or in any way, be it
electronically, mechanically, by photocopying, recordings or in any other
way, without prior written permission from GymnaUniphy N.V.
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Pulson 100
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User Manual Pulson 100
Device for ultrasound therapy
Manufacturer GymnaUniphy N.V.
Main office Pasweg 6A
B-3740 BILZEN
Telephone +(32) (0)89-510.510
Fax +(32) (0)89-510.511
E-mail [e-mail]
Website www.gymna-uniphy.com
Version 1.0
September 2007
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Abbreviations
Symbols on the equipment
Symbols in the manual
EMC Electromagnetic Compatibility
ESD Electrostatic Discharge
HAC Hospital Antiseptic Concentrate
US Ultrasound
Read the manual
Manufacturer
Warning or important information.
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TABLE OF CONTENTS
1 SAFETY ............................................................................................ 5
1.1 PURPOSE .................................................................... 5
1.2 SAFETY INSTRUCTIONS ................................................... 5
1.3 MEDICAL DEVICES DIRECTIVE ........................................... 7
1.4 LIABILITY .................................................................... 7
2 INSTALLATION ................................................................................ 9
2.1 RECEIPT ...................................................................... 9
2.2 PLACING AND CONNECTION .............................................. 9
2.3 PERFORMING THE FUNCTIONAL TEST ................................... 9
2.4 TRANSPORT AND STORAGE .............................................. 9
2.5 RESELLING ................................................................... 9
3 DESCRIPTION OF THE EQUIPMENT ............................................ 11
3.1 PULSON 100 AND STANDARD ACCESSORIES ....................... 11
3.2 COMPONENTS OF THE PULSON 100 ................................. 12
3.3 DISPLAY ................................................................... 13
3.4 DISPLAY SYMBOLS ....................................................... 13
3.5 PARAMETER SYMBOLS .................................................. 14
4 OPERATION ................................................................................... 15
4.1 POWER UP ................................................................. 15
4.2 PARAMETER SETTING .................................................... 15
4.3 PERFORMING ULTRASOUND THERAPY ................................ 16
4.4 READ OUT VALUES ...................................................... 17
4.5 SYSTEM SETTINGS ....................................................... 18
5 INSPECTIONS AND MAINTENANCE ........................................... 21
5.1 INSPECTIONS .............................................................. 21
5.2 MAINTENANCE ............................................................ 22
6 MALFUNCTIONS, SERVICE AND GUARANTEE ......................... 23
6.1 MALFUNCTIONS .......................................................... 23
6.2 SERVICE ................................................................... 24
6.3 GUARANTEE ............................................................... 24
6.4 TECHNICAL LIFE TIME ................................................... 25
7 TECHNICAL INFORMATION ......................................................... 27
7.1 GENERAL .................................................................. 27
7.2 ULTRASOUND THERAPY ................................................. 27
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7.3 ENVIRONMENTAL CONDITIONS ......................................... 28
7.4 TRANSPORT AND STORAGE ............................................ 28
7.5 STANDARD ACCESSORIES .............................................. 29
7.6 OPTIONAL ACCESSORIES ............................................... 30
8 APPENDICES ................................................................................. 31
8.1 EMC DIRECTIVE .......................................................... 31
8.2 TECHNICAL SAFETY INSPECTION ...................................... 35
8.3 DISPOSAL ................................................................. 37
9 REFERENCE ................................................................................... 39
9.1 Function overview ..................................................... 39
9.2 LITERATURE ............................................................... 40
10 INDEX ............................................................................................. 41
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1SAFETY
1.1 Purpose
The Pulson 100 is intended solely for medical applications. You can use the
Pulson 100 for ultrasound therapy. 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 'Directive on Medical Devices' from the European
Commission (93/42/EEG) requires that safe devices are used.
It is recommended to perform a yearly technical safety
inspection. See §5.1.2.
•For optimum treatment, a patient investigation must first be
performed. On the basis of the findings of the investigation, a
treatment plan with objectives will be formulated. Follow the
treatment plan during the therapy. This will limit possible risks,
related to the treatment, to a minimum.
•Always keep these user instructions with the equipment.
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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 §7.5 and §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 §7.5
and §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.
2.2 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 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.
2.5 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 100
3DESCRIPTION OF THE EQUIPMENT
3.1 Pulson 100 and standard accessories
1. Pulson 100. See §3.2.
2. Power cord
3. Contact gel
4. US head
3
2
1
4
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3.2 Components of the Pulson 100
1. Display. See §3.3.
2. Decrease the selected
parameter
3. Increase the selected
parameter
4. Indication: Read manual
5. Enter
6. Timer
7. Connector for US head
8. Indication: Floating patient
circuit
9. On/off switch
10. Connection to mains supply
11. Type plate
12. Ventilation opening
13. Fuse holder
!
23
1
5
6
4
78
9 10 11 12
13
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Pulson 100
3.3 Display
1. Treatment mode
2. Program number/System
settings number
3. System settings mode
4. Intensity symbol
5. Treatment time symbol
6. Timer on/off during bad US
contact
7. Timer value
8. Ultrasound frequency
9. Ultrasound output indication
10. Type of US head
11. Ultrasound output power
12. Duty cycle symbol
13. Ultrasound intensity value
14. Duty cycle value
3.4 Display symbols
1
657
2
4
3
9
8
10
11
12 1413
Program number Treatment time
System settings Ultrasound output
Timer Off during bad
contact US head 1 cm2
US head 4 cm2
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3.5 Parameter symbols
Intensity Output power
Duty cycle Ultrasound frequency
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4OPERATION
4.1 Power up
The Pulson 100 starts up in
program number 00 with the
following parameters:
•Treatment Time: 7:30
•Intensity 0.1 W/cm2
•Duty cycle: 100%
The type of US head will be detected automatically by the Pulson 100.
If no US head is connected, the symbols and are displayed
alternating.
The Ultrasound frequency is fixed at 1 MHz.
4.2 Parameter setting
The parameter symbol blinks to indicate which parameter can be
changed (program number, time, intensity, duty cycle).
•Press or to decrease or increase the parameter value.
•Press to confirm the value and select the next parameter.
4.2.1 Parameters
Program number (0 - 11)
The selected program number. See §9.1.2.
Every program number is related to an indication (See §9.1.2.) and
contains advised parameter values. The parameter values of each
program can still be changed.
Treatment time (mm:ss)
The duration of the treatment.
The value can be set in steps of 15 seconds.
Intensity (W/cm2)
The power (W) of the US head per cm2.
The value can be set in steps of 1.0 W/cm2.
Duty cycle (10, 20, 30, 40, 50, 100%)
Ratio of the pulse duration to the period duration.
•100%: Continuous ultrasound.
•10, 20, 30, 40, 50%: Pulsating ultrasound.
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4.3 Performing ultrasound therapy
If no USTH is connected, the symbols and are displayed
alternating. The treatment can not be started.
1. Plug the connector of the US
head into the connector of
the Pulson 100.
2. Select the desired program
number. For the US head
placement see §9.1.2. for 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. Press . The Ultrasound
treatment starts.
6. Move the US head evenly over
the skin during the treatment.
This prevents internal burns.
7. Check the patients 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.
Move the US head evenly over the skin during the treatment.
This prevents internal burns.
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4.4 Read out values
1. Remaining treatment time.
2. Ultrasound frequency.
3. Ultrasound output symbol.
4. Output power.
Remaining treatment time (mm:ss)
Counts down during treatment
Ultrasound frequency
Fixed value: 1 MHz.
Ultrasound output symbol
•wave animation: good US contact.
•blinks: bad US contact.
Test the US head if the conduction is bad. Refer to §5.1.1.
Output power (W)
The output power is the calculated value of Iset x ERA x duty cycle. The
power 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.
1
3
2
4
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4.5 System settings
•Press and hold for 3 seconds to enter or leave the system
settings menu.
•Press to confirm the value and to select the next system setting.
4.5.1 01: Stop time if bad US
1. Press or to switch the
parameter ON or OFF.
•ON: the dashed arrow is
visible. During bad US
contact the timer will stop
countdown (the arrow is
only visible in system
setting mode).
•OFF: the dashed arrow is
invisible. During bad US
contact the timer will
continue countdown.
4.5.2 02: Automatic Frequency tuning
The stored default frequency (kHz)
is displayed.
•US headsize or is
displayed if a head is
connected.
•If no US head is connected, the
symbols and are
displayed alternating.
1. Press to start frequency tuning if a US head is connected. The
%-value of the duty cycle counts up to 100%.
2. The tuned frequency value (kHz) is displayed.
4.5.3 03: HW code
The hardware code of the main
PCB is displayed.
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