Gymna VACO 200 User manual

VACO 200
User Manual
Gebrauchsanweisung
Manuel d'utilisation
Gebruikershandleiding
Manual de usuario
Manual do Utilizador
Manuale d'uso
0344
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 / Uw dealer / Votre
distributeur / Ihr Fachhändler / Su
distribuidor / O seu fornecedor / Il
distributore
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Vaco 200
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English .......................................................................... 3
Nederlands .................................................................... 29
Français ......................................................................... 55
Deutsch ......................................................................... 81
Español ........................................................................ 109
Português .....................................................................135
Italiano ..................................................................... 161
© 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
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con qualunque altro metodo, senza previa autorizzazione scritta da parte di GymnaUniphy N.V.
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Vaco 200
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User Manual Vaco 200
Device for the application of electrotherapy using vacuum
electrodes
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
June 2007
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Abbreviations
Symbols on the equipment
Symbols in the manual
EMC Electromagnetic Compatibility
EL Electrode
ET Electrotherapy
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 ................................................................ 10
2.1 RECEIPT .................................................................... 10
2.2 PLACING AND CONNECTION ............................................ 10
2.3 USE IN COMBINATION WITH ANOTHER DEVICE ...................... 10
2.4 TRANSPORT AND STORAGE ............................................ 10
2.5 RESELLING ................................................................. 10
3 DESCRIPTION OF THE EQUIPMENT .................................... 11
3.1 VACO 200 AND STANDARD ACCESSORIES ......................... 11
3.2 COMPONENTS OF VACO 200 ......................................... 12
4 OPERATION ..................................................................... 13
4.1 PERFORMING ELECTROTHERAPY WITH THE VACO 200 ........... 13
4.2 CONNECTING THE ELECTRODES ........................................ 14
4.3 THE WATER RESERVOIR IS FULL ....................................... 16
4.4 REFERENCE ................................................................ 16
5 INSPECTIONS AND MAINTENANCE .................................... 17
5.1 INSPECTIONS .............................................................. 17
5.2 MAINTENANCE ............................................................ 18
6 MALFUNCTIONS, SERVICE AND GUARANTEE ..................... 20
6.1 MALFUNCTIONS .......................................................... 20
6.2 SERVICE ................................................................... 21
6.3 GUARANTEE ............................................................... 21
6.4 TECHNICAL LIFE TIME ................................................... 22
7 TECHNICAL INFORMATION ............................................... 23
7.1 GENERAL .................................................................. 23
7.2 ENVIRONMENTAL CONDITIONS ......................................... 23
7.3 TRANSPORT AND STORAGE ............................................ 23
7.4 STANDARD ACCESSORIES .............................................. 24
7.5 OPTIONAL ACCESSORIES ................................................ 24
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8 APPENDICES .................................................................... 25
8.1 TECHNICAL SAFETY INSPECTION ...................................... 25
8.2 EMC DIRECTIVE .......................................................... 26
8.3 DISPOSAL ................................................................. 26
8.4 LITERATURE ............................................................... 26
9 INDEX ............................................................................. 27
10 REFERENCE EMC DIRECTIVE ........................................... 189
10.1 GUIDANCE AND DECLARATION ....................................... 189
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1SAFETY
1.1 Purpose
The Vaco 200 is intended solely for medical applications. The Vaco 200
is a vacuum suction device for fast and efficient electrode placement.
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.
•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.
•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 §5.1.1.
•Disconnect the equipment from the patient before
switching the power on or off.
•Be careful, in combination with an electrotherapy device
the output of the Vaco 200 can have physiological effects.
See the ‘Safety instructions’ in the user manual of the
electrotherapy device.
•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 Accessories
•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.
•When the device operates in the vicinity of equipment
other than those mentioned in §2.3, verify that the Vaco
200 operates normally.
•Only use the accompanying accessories that are supplied
by GymnaUniphy. See §7.4 and §7.5.
Other accessories can lead to an increased emission or a
reduced immunity.
•Check the electrode cables and the electrodes at least once
a month. Check whether the insulation is still intact. See
§5.1.
•Use always demineralized water with vacuum electrodes to
avoid lime deposits in the watertank, the tubes and the
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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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 via
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 §7.4.
•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.
•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 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 Use in combination with another device
The Vaco 200 can be used in combination with:
•The Combi200.
•The Combin200L.
•The Duo200.
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 and some
accessories have a unique serial number. Provide the dealer with the
name and address of the new owner.
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11
Vaco 200
3DESCRIPTION OF THE EQUIPMENT
3.1 Vaco 200 and standard accessories
1. Vaco 200. See §3.2.
2. Power cord
3. Vacuum hose (4 pieces)
4. Connection cable: ET device -
Vaco 200 (2 pieces)
5. Sponge for vacuum electrode
(4 pieces)
6. Vacuum electrode (4 pieces)
3
4
2
5
6
1
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3.2 Components of Vaco 200
1. Vacuum intensity regulator
2. Pulse regulator
3. LED water reservoir
4. Indication: Read manual
5. Indication: Floating patient
circuit
6. LED: vacuum output channel
A active
7. Output connectors
for vacuum electrodes
8. LED: traditional output
channel A active
9. Output connector
for two-ply electrode cable
10. LED traditional output channel
B active
11. Output connector
for two-ply electrode cable
12. LED: vacuum output channel
B active
13. Output connectors
for vacuum electrodes
14. Push button channel B
15. Input connector channel B for
connection cable
16. Input connector channel A for
connection cable
17. On/off switch
18. Fuse holder
19. Connection to mains supply
20. Drain hose for water reservoir
21. Air exhaust
22. Type plate
VAC O 200
9 1411654
21 2220191817
7
1
1615
2
3
13
810 12
A
A
B
B
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4OPERATION
4.1 Performing electrotherapy with the Vaco 200
1. Connect the Vaco 200 and the electrotherapy device to the mains
supply.
2. Connect the input connector A of the Vaco 200 to the output
connector A of the electrotherapy device with the connection cable.
If necessary, do the same for channel B.
3. Turn the vacuum intensity regulator to the position.
4. Use the switch on the rear panel to set the Vaco 200 and the
electrotherapy device to on. The LEDs from the traditional channels
of the Vaco 200 light up. The LEDs show which output channel is
connected with the electrotherapy device.
5. Select the desired electrotherapy program.
6. Connect, adjust and place the electrodes. See §4.2.1, §4.2.2, §4.2.3
and §4.2.4.
7. Turn the intensity knob A or B of the ET device to start the
electrotherapy and to set the desired intensity.
8. Check the patient's reaction. Repeat this check regularly during the
treatment.
9. The electrotherapy device stops the treatment and indicates that
the treatment is completed.
10. If vacuum is used, turn the vacuum intensity regulator to . For
safety, the vacuum stops automatically two minutes after the
treatment stops and the vacuum channel LEDs flash. Turn the
vacuum intensity regulator to to make a new treatment
selection possible.
11. Remove the electrodes. If necessary put your finger under the rim of
the vacuum electrode for air inled.
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4.2 Connecting the electrodes
4.2.1 Using four vacuum electrodes
1. If present disconnect the vaginal,
anal and rectal stimulation
probes.
2. Connect the vacuum electrodes
to the vacuum hoses.
3. Connect the four vacuum hoses.
Select two cables with the same
hose colour for each channel.
1 Connect the red connectors
from the vacuum hoses to
the output connectors with
the red dot.
2 Connect the black connectors from the vacuum hoses to the
output connectors with the black dot.
4. Moisten the round sponges.
5. Put the sponges in the vacuum electrodes.
6. Turn the vacuum intensity regulator to and regulate the desired
suction force.
7. Place the vacuum electrodes on the part of the body that must be
treated. The vacuum electrodes stay in place by the underpressure.
Too high suction cause patient discomfort.
8. Turn the pulse vacuum suction power regulator to for patient
comfort.
9. Select the stimulaton signal on the vacuum output with the push
button. The LED vacuum channel B is lit.
•Use always demineralized water with vacuum electrodes to
avoid lime deposits in the watertank, tubes and sponges.
Add a saline solution to improve the electrical conduction.
•Use moist sponges only. Too dry sponges can cause a bad
electrical contact and burn the skin.
•Do not use vacuum electrodes with DC current. The DC
current causes damage to the vacuum cups by ionization.
B
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4.2.2 Using two vacuum electrodes
1. If present disconnect the vaginal,
anal and rectal stimulation
probes.
2. Connect two vacuum electrodes
to the vacuum hoses. Select two
cables with the same hose
colour.
3. Connect the red connector from
the vacuum hose to the channel
A output connector with the red
dot.
4. Connect the black connector from the vacuum hose to the channel
A output connector with the black dot.
5. Connect a vacuum hose for a closed vacuum system to make a
short-circuit across the channel B output connectors.
6. Moisten the round sponges.
7. Put the sponges in the vacuum electrodes.
8. Turn the vacuum intensity regulator to and regulate the desired
suction force.
9. Place the vacuum electrodes on the part of the body that must be
treated. The vacuum electrodes stay in place by the underpressure.
Too high suction cause patient discomfort.
10. Turn the pulse vacuum suction power regulator to for the
patient comfort.
4.2.3 Using traditional electrodes
1. Prepare the traditional
electrodes. See the User
Manual of the ET device.
2. Connect the two-ply cable to
the corresponding output
connector or of the
Vaco 200.
A
B
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4.2.4 Using a combination of vacuum and traditional electrodes
Use channel A for the stimulated vacuum electrodes and use channel B
for the traditional electrodes.
1. Connect two vacuum
electrodes to channel A and
short-circuit channel B. See
§4.2.2.
2. Prepare the traditional
electrodes. See the User
Manual of the ET device.
3. Connect the two-ply cable to
the output connector of
the Vaco 200.
4.3 The water reservoir is full
1. The LED of the water reservoir light up. Finish the present
treatment. After you turn the vacuum off, you can not restart the
vacuum.
2. Empty the water reservoir with the drain hose. The start of a
vacuum treatment is possible.
3. Clean the water reservoir. See §5.2.4.
4.4 Reference
4.4.1 Indications
The Vaco 200 can be used for the pathologies from the indication list of
the electrotherapy device. See the User Manual of the ET device.
4.4.2 Contra indications
•The contra indications from the electrotherapy device. See the User
Manual of the ET device.
•Internal infections
•Hemorrhagic risk in the part of the body where the electrodes are to
be placed.
B
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5INSPECTIONS AND MAINTENANCE
5.1 Inspections
5.1.1 Technical safety inspection
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. If the legislation in your
country or your insurer prescribes a shorter period, you must adhere to
this shorter period.
Inspection points
The technical safety inspection include the following tests:
1. Test 1: General: Visual inspection and check on the operating
functions
2. Test 2: Electrical safety inspection: measurement of the earth
leakage current and patient leakage current according to DIN/VDE
0751-1 ed. 2.0.
Inspection result
1. A registration must be maintained of the technical safety
inspections. Use the inspection report in the appendix for this
purpose. See §8.1.
2. Copy this appendix.
3. Complete the copied appendix.
4. Keep the inspection reports for at least 10 years.
Component Check Frequency
Electrode cables
and electrodes
Damage
Insulation intact
At least 1x per month
Equipment Technical safety
inspection. See §5.1.1.
At least 1x per year
•Only a technician authorised by GymnaUniphy N.V. may
open the equipment or the accessories.
•The inspection may only be performed by a suitably
qualified person. In some countries this means that the
person must be accredited.
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The inspection is successful if all inspection items are passed.
Repair all faults on the equipment before the equipment is put back into
operation.
By comparing the registered measurement values with previous
measurements, a possible slowly-deteriorating deviation can be
ascertained.
5.2 Maintenance
5.2.1 Cleaning the Vaco 200 unit
1. Switch the equipment off.
2. Clean the device with a lightly moistened soft cloth.
5.2.2 Cleaning the vacuum electrodes
1. Clean the vacuum electrodes (metal electrodes and rubber suction
cups) in a non-aggressive soap solution or in a 70% alcohol
solution.
2. Rinse the vacuum electrodes thoroughly with water.
3. Dry the vacuum electrodes.
5.2.3 Cleaning the sponges for vacuum electrodes
1. Rinse the sponges thoroughly with water or clean the sponges with
a 70% alcohol solution.
2. Rinse the sponges thoroughly with water.
Component Check Frequency
Vaco 200 unit Cleaning. See §5.2.1. If necessary
Vacuum
electrodes
Cleaning. See §5.2.2. After every treatment
Sponges Cleaning. See §5.2.3. After every treatment
Vacuum hoses
and water
reservoir
Cleaning. See §5.2.4. Weekly
Accessories that come in contact with the body of the patient
must be washed with pure water after the disinfection to
prevent allergic reactions.
No liquid may enter the device.
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5.2.4 Cleaning the vacuum hoses and the water reservoir
1. Empty the water reservoir with the drain hose.
2. Connect the vacuum hoses.
3. Put the ends of the vacuum hoses in a 70% alcohol solution.
4. Turn the vacuum unit on.
5. Suck the liquid up until the LED of the water reservoir lits.
6. Turn the vacuum unit off.
7. Empty the water reservoir.
8. Repeat steps 3 until 7 with pure water.
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6MALFUNCTIONS, SERVICE AND GUARANTEE
6.1 Malfunctions
6.1.1 Equipment cannot be switched on
1. Check if the mains voltage has failed.
2. Check if the main switch is switched on (“I”).
3. Check if the power cord and the fuses are in order. If necessary,
replace the fuses. See §6.1.2.
4. Contact your dealer if the equipment still cannot be switched on.
6.1.2 Replacing the fuses
1. Switch the main switch off (“O”).
2. Unplug the power cord from the equipment.
3. Pull the fuse holder carefully out of the equipment. If necessary, use
a screwdriver.
4. Replace both fuses. If necessary, order new fuses from your dealer.
5. Install the fuse holder and plug in the power cord.
6. Switch the main switch on again (“I”).
6.1.3 Equipment does not react to commands
The safety system of the equipment has ascertained a fault. You cannot
continue to work.
1. Disconnect the connection to the patient.
2. Switch the main switch off (“O”).
3. Wait 5 seconds and switch the main switch on again (“I”).
4. Contact your dealer if the fault reappears.
Component Problem Solution
Vaco 200 unit Equipment cannot be
switched on
See §6.1.1.
Equipment does not react to
commands
See §6.1.3.
Vacuum
electrodes
Contamination by ionization See §6.1.4.
Sponges Furring Replace the sponges
Bad conduction Replace the sponges
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