Gymna Combi 400 User manual

User Manual
Pasweg 6A
B-3740 Bilzen
Tel.: (+32) (0) 89/510.510
Fax: (+32) (0) 89/510.511
www.gymna.com
E-mail: [e-mail]
Your dealer:

400-Series
2
© 2010, 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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User Manual 400-Series
Devices for electrotherapy, ultrasound therapy, combination
therapy and laser therapy with GTS2
Electro
therapy
Ultrasound
therapy
Combination
therapy
Laser
therapy
Vacuum
(optional)
Combi
400
xx xxx
Duo 400 x x
Pulson
400
x
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.com
Version 0.1
September 2010

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Symbols on the equipment
Abbreviations
Symbols in the manual
Attention, read the
manual
Points to laser aperture
and shows direction of
beam
Manufacturer
AQ Accomodation Quotient
CC Constant Current
CO Combination therapy
CP Courte Période
CV Constant Voltage
DF Diphasé Fixe
EL Electrode
EMC Electromagnetic Compatibility
ESD Electrostatic Discharge
ET Electrotherapy
HAC Hospital Antiseptic Concentrate
LA Laser therapy
LP Longue Période
MF Medium Frequency: with unidirectional and interferential
currents
Monophasé Fixe: with diadynamic currents
MTP Myofascial Trigger Point
NMES Neuro Muscular Electro Stimulation
TENS Transcutaneous Electrical Nerve Stimulation
US Ultrasound
VAS Visual Analogue Scale
Â, Î A circumflex on a symbol indicates a peak value
Warning or important information.

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TABLE OF CONTENTS
1 SAFETY ............................................................................. 9
1.1 PURPOSE .................................................................... 9
1.2 SAFETY INSTRUCTIONS ................................................... 9
1.3 CONTRAINDICATIONS .................................................... 13
1.4 DIRECTIVES ............................................................... 15
1.5 LIABILITY .................................................................. 15
2 INSTALLATION ................................................................ 17
2.1 RECEIPT .................................................................... 17
2.2 PLACING AND CONNECTION ............................................ 17
2.3 PLACE THE VACO 400 OPTION ....................................... 17
2.4 USE IN COMBINATION WITH ANOTHER DEVICE ...................... 17
2.5 PERFORMING THE FUNCTIONAL TEST ................................. 17
2.6 SETTING LANGUAGE, TIME AND PREFERENCES ...................... 18
2.7 TRANSPORT AND STORAGE ............................................ 18
2.8 RESELLING ................................................................. 18
3 DESCRIPTION OF THE EQUIPMENT .................................... 19
3.1 COMBI 400 WITH STANDARD ACCESSORIES ....................... 19
3.2 DUO 400 WITH STANDARD ACCESSORIES .......................... 20
3.3 PULSON 400 WITH STANDARD ACCESSORIES ...................... 21
3.4 VACO 400 WITH STANDARD ACCESSORIES ........................ 22
3.5 COMPONENTS OF 400-SERIES ........................................ 23
3.6 DISPLAY ................................................................... 24
3.7 DISPLAY SYMBOLS ....................................................... 27
3.8 PARAMETER SYMBOLS .................................................. 27
3.9 CURRENT SHAPES ....................................................... 28
4 OPERATION ..................................................................... 33
4.1 THERAPY SELECTION .................................................... 33
4.2 PERFORMING THERAPY .................................................. 36
4.3 ELECTRO THERAPY ...................................................... 37
4.4 ULTRASOUND THERAPY ................................................ 42
4.5 COMBINATION THERAPY ............................................... 44
4.6 LASER THERAPY ......................................................... 45
4.7 ACCESSING THE ANATOMICAL LIBRARY ............................. 47
4.8 DIAGNOSTICS ............................................................. 48
4.9 MEMORY .................................................................. 50
4.10 SYSTEM SETTINGS ....................................................... 54
4.11 VACUUM ................................................................. 58

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5 INSPECTIONS AND MAINTENANCE .................................... 61
5.1 INSPECTIONS .............................................................. 61
5.2 MAINTENANCE ............................................................ 64
6 MALFUNCTIONS, SERVICE AND GUARANTEE ..................... 67
6.1 MALFUNCTIONS .......................................................... 67
6.2 SERVICE ................................................................... 68
6.3 GUARANTEE ............................................................... 68
6.4 TECHNICAL LIFE TIME ................................................... 69
7 TECHNICAL INFORMATION ............................................... 71
7.1 GENERAL .................................................................. 71
7.2 ELECTRO THERAPY ...................................................... 71
7.3 VACUUM OPTION ........................................................ 74
7.4 ULTRASOUND THERAPY ................................................ 74
7.5 LASER THERAPY ......................................................... 76
7.6 ENVIRONMENTAL CONDITIONS ......................................... 76
7.7 TRANSPORT AND STORAGE ............................................ 77
7.8 STANDARD ACCESSORIES .............................................. 77
7.9 OPTIONAL ACCESSORIES ............................................... 79
8 APPENDICES .................................................................... 83
8.1 AGENTS FOR IONTOPHORESIS ......................................... 83
8.2 DIAGNOSTIC S-D CURVE ............................................... 84
8.3 ELECTRODE, US HEAD AND LASER PROBE PLACEMENTS ......... 84
8.4 EMC DIRECTIVE .......................................................... 85
8.5 TECHNICAL SAFETY INSPECTION ...................................... 90
8.6 DISPOSAL ................................................................. 95
9 REFERENCE ..................................................................... 97
9.1 LITERATURE ............................................................... 97
9.2 Terminology ............................................................. 97

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1SAFETY
1.1 Purpose
The 400-Series is intended solely for medical applications. A trained
professional can use the 400-Series for electro therapy, ultrasound
therapy, combination therapy and laser 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 §5.2.1.
•The Council directive 93/42/EEC concerning medical
devices, requires medical devices to be safe. Therefore it is
necessary to perform each year a technical safety
inspection. See §5.1.3.
•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
•Only use the equipment in an area with facilities that meet
the applicable legal regulations.
•Connect the equipment to an outlet with an earth terminal.
The outlet must meet the locally applicable requirements
for medical areas. The device is Class II with a functional
earth for EMC purposes
•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 accessories that are specified by
GymnaUniphy. See §7.
Other accessories can lead to an increased emission or a
reduced immunity.

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1.2.5 Electro therapy
1.2.6 Ultrasound therapy
•Do not use the equipment simultaneously with high
frequency surgical equipment. This combination can cause
burning of the skin under the electrodes.
•Patients with electrical implants (e.g. a pacemaker) may
only be treated after obtaining specialist medical opinion.
•Do not use adhesive electrodes with currents that have a
galvanic component, such as galvanic, diadynamic, MF
rectangular, pulsed rectangular and triangular currents.
With these currents, etching of the skin can occur.
•Application of electrodes near the thorax may increase the
risk of cardiac fibrillation.
•Check the electrode cables and the electrodes at least once
a month. Check whether the insulation is still intact.
•Check the conductivity of rubber electrodes at least once a
a week. See §4.10.4.
•The safety standards for electrical stimulation advise not to
exceed the current density of 2.0 mArms/cm2.
However, with iontophoresis treatments, we advise a
maximum current density of 0.25 mÂ/cm2, because of
using the MF rectangular current. Exceeding this value can
result in skin irritation and burns.
•Always use sterilised gauze with iontophoresis treatments.
•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 §5.1.2.
•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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1.2.7 Laser therapy
The laser is a class 3B laser product which emits invisible infrared light.
•Make sure the laser warning sign is clearly visible outside
the entrance to the therapy room.
•The radiation of a laser probe can cause a physiological
effect.
•Use the laser therapy only for therapeutic purposes.
•Use of controls or adjustments or performance of
procedures other then those specified in this manual may
result in hazardous radiation exposure.
•Start a laser therapy only when all persons in the room
wear laser goggles for eye protection. If you do not obey
this warning, you can cause blindness. Use goggles with at
least the characteristics: I 100 - 1000 L2 and with a clear
view of the control, the display and the signal lights. See
§7.5.
•Do not look into the laser beam during a laser therapy.
•Do not point the laser beam into eyes.
•Do not use the laser near flammable materials or liquids.
•Do not use the equipment if any damage shows.
•Regulary check the output of the laser probe with the test
facility. See §4.10.8.
•Check the laser probe at least once a month. During the
check, look for dents, cracks and other damage. Check
whether the insulation of the cable is still intact. Check
whether all pins are present and straight in the connectors.
Replace the laser probe if the laser, the cable or the
connector is damaged. See §5.1.
•Place the laser probe in the holder when the laser is not
used.
•Lock the laser function when the laser therapy is not used.

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1.2.8 Vacuum accessories
1.3 Contraindications
1.3.1 Electro therapy
General
•High fever
•Severe cardiovascular problems
•Psychological problems
•Cancer with tumor metastasis
•Generalised tuberculosis
Specific absolute
•On demand pacemakers
Specific relative for monophasic
pulses
•Skin lesions
•Skin infections
•Thrombosis, thrombophlebitis
•Varices
•Increased risk to haemorrhage
•Superficially implanted materials
•Heart disease, rhythm disorder
•Decreased sensibility
•Locat. near sinus caroticus
•Menses
•Pregnancy
•Check the electrode cables and the electrodes at least
once a month. Check whether the insulation is still intact.
See §5.1
•Always use slightly salinated demineralized water to
moisturize the vacuum sponges to prevent lime deposits in
the watertank, hoses, cups and sponges.
•Use only moisten sponges. Too dry sponges can cause
burning of the skin under the electrodes.
•Do not use vacuum electrodes with DC currents. The DC
currents cause damage to the vacuum cups by ionization.

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Specific for relative biphasic pulses
•Skin infections
•Thrombosis, thrombophlebitis
•Heart disease, rhythm disorder
•Decreased sensibility
•Locat. near sinus caroticus
•Pregnancy
1.3.2 Ultrasound therapy
General
•High fever
•Severe cardiovascular problems
•Psychological problems
•Cancer with tumor metastasis
•Generalised tuberculosis
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
1.3.3 Combination therapy
See contraindications §1.3.1 Electro therapy, page 13 and §1.3.2
Ultrasound therapy, page 14.

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1.3.4 Laser therapy
General
•High fever
•Severe cardiovascular problems
•Psychological problems
•Cancer with tumor metastasis
•Generalised tuberculosis
Specific absolute
•Looking into the laser beam
•Thyroid gland (local applications)
•Increased connective tissue production
•Hypertrophic scars
•Pregnancy
•Photo-allergy
1.4 Directives
1.4.1 Medical Devices Directive
The device complies with the essential requirements of the Council
directive 93/42/EEC concerning medical devices (MDD) as most recently
changed.
The device contains no human or animal tissue, no medical substances,
and no blood or blood products from human or animal origin.
1.4.2 Directive on waste electrical and electronic equipment
The device complies with the requirements of directive 2002/96/EC of
the European parliament and of the council on waste electrical and
electronic equipment (WEEE) as most recently changed.
1.5 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 via the
vaginal, anal and rectal probes and/or other 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.
•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 an earth terminal.
2.3 Place the Vaco 400 option
The Vaco 400 is designed to be placed underneath a 400-Series device.
See §3.5.
1. Connect the 5-pin connection cable (4).
2. Connect the 6-pin connection cable (5).
2.4 Use in combination with another device
The Vaco 400 can only be used in combination with:
•The Combi 400
•The Duo 400
2.5 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.
3. If the display does not light up: See §6.1.1.

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2.6 Setting language, time and preferences
1. Press on the home screen. The System settings menu appears.
See §4.10.1.
2. Select Touch panel calibration.
3. Press Start and follow the instructions on the screen.
4. Select Language and select the language with which the read-out
must work.
5. Select Date & Time.
6. Select Day.
7. Set the day with and .
8. Repeat steps 6 and 7 for the Month, Year, Hour, Minutes and
Seconds
2.7 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.
2.8 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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400-Series
3DESCRIPTION OF THE EQUIPMENT
3.1 Combi 400 with standard accessories
1. Combi 400. See §3.5.
2. Touchscreen pen
3. CD-ROM User manual
4. Safety instructions
5. Power cord
6. Contact gel
7. US head large incl. holder
8. VAS score card
9. Elastic fixation straps (4
pieces)
10. EL sponges for rubber
electrode (4 pieces)
11. Rubber electrodes (4 pieces)
12. Two-ply electrode cable (2
pieces)
13. Quickstart guide
12
11
6
5
10 9
1 2
8
4
3
7
13

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3.2 Duo 400 with standard accessories
1. Duo 400. See §3.5.
2. Touchscreen pen
3. CD-ROM User manual
4. Safety instructions
5. Power cord
6. Contact gel
7. VAS score card
8. Elastic fixation straps (4
pieces)
9. EL sponges for rubber
electrode (4 pieces)
10. Rubber electrodes (4 pieces)
11. Two-ply electrode cable (2
pieces)
12. Quickstart guide
11
10
6
5
98
1 2
7
4
3
12