Gymna PULSON 200 User manual

PULSON 200
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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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 PURPOSE ...................................................................................... 7
1.2 SAFETY INSTRUCTIONS................................................................... 7
1.3 MEDICAL DEVICES DIRECTIVE ........................................................ 9
1.4 LIABILITY ....................................................................................... 9
2 INSTALLATION................................................................................... 11
2.1 RECEIPT ...................................................................................... 11
2.2 PLACING AND CONNECTION .......................................................... 11
2.3 PERFORMING THE FUNCTIONAL TEST ............................................ 11
2.4 SETTING CONTRAST AND SELECTING LANGUAGE............................ 11
2.5 TRANSPORT AND STORAGE........................................................... 12
2.6 RESELLING .................................................................................. 12
3 DESCRIPTION OF THE EQUIPMENT ................................................ 13
3.1 COMPONENTS OF PULSON 200 .................................................... 14
3.2 DISPLAY ...................................................................................... 15
3.3 DISPLAY SYMBOLS ....................................................................... 16
3.4 PARAMETER SYMBOLS.................................................................. 16
4 OPERATION........................................................................................ 17
4.1 THERAPY SELECTION.................................................................... 17
4.2 SET AND START THERAPY ............................................................ 20
4.3 ULTRASOUND THERAPY ................................................................ 21
4.4 PROGRAMS.................................................................................. 24
4.5 SYSTEM SETTINGS ....................................................................... 26
5 INSPECTIONS AND MAINTENANCE ................................................ 29
5.1 INSPECTIONS ............................................................................... 29
5.2 MAINTENANCE ............................................................................. 31
6 MALFUNCTIONS, SERVICE AND GUARANTEE .............................. 33
6.1 MALFUNCTIONS............................................................................ 33
6.2 SERVICE...................................................................................... 34
6.3 GUARANTEE ................................................................................ 34
6.4 TECHNICAL LIFE TIME ................................................................... 35
7 TECHNICAL INFORMATION .............................................................. 37
7.1 GENERAL..................................................................................... 37
7.2 ULTRASOUND THERAPY ................................................................ 37
7.3 ENVIRONMENTAL CONDITIONS....................................................... 38
7.4 TRANSPORT AND STORAGE........................................................... 38
7.5 STANDARD ACCESSORIES............................................................. 39
7.6 OPTIONAL ACCESSORIES .............................................................. 39

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8 APPENDICES...................................................................................... 41
8.1 EMC DIRECTIVE........................................................................... 41
8.2 TECHNICAL SAFETY INSPECTION ................................................... 45
8.3 DISPOSAL .................................................................................... 47
9 REFERENCE....................................................................................... 49
9.1 TERMINOLOGY ............................................................................. 49
9.2 LITERATURE................................................................................. 49
9.3 FUNCTION OVERVIEW ................................................................... 51
9.4 INDEX .......................................................................................... 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, 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 Setting 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.