GymnaUniphy Vaco 500 User manual
Vaco 500
English ........................................................................................ 3
Nederlands .................................................................................. 27
Français ....................................................................................... 53
Deutsch ....................................................................................... 79
Español .......................................................................................107
Português ..................................................................................133
© 2004, 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.
Alle rechten voorbehouden. Niets uit deze uitgave mag worden vermenigvuldigd,
opgeslagen in een geautomatiseerd gegevensbestand, of openbaar gemaakt, in
enige vorm of op enige wijze, hetzij elektronisch, mechanisch, door fotokopieën,
opnamen of op enige andere manier, zonder voorafgaande schriftelijke
toestemming van GymnaUniphy N.V.
Tous droits réservés. La reproduction, même partielle, de ce document, son
stockage sur fichier automatisé, publication, sous quelque forme que ce soit,
électroniquement, mécaniquement, photocopie, enregistrements ou par tout autre
procédé, sont interdits sans l’autorisation écrite de GymnaUniphy N.V.
Alle Rechte vorbehalten. Kein Teil dieser Ausgabe darf ohne die vorherige
schriftliche Genehmigung von GymnaUniphy N.V in irgendeiner Form, elektronisch,
mechanisch, durch Photokopieren, Aufnehmen oder auf eine andere Art, kopiert, in
einer automatisierten Datei gespeichert oder veröffentlicht werden.
Todos los derechos reservados. Ninguna parte de esta publicación puede ser
copiada, almacenada en un archivo de datos informático o divulgada, en cualquier
otra forma o modo, bien sea electrónica o mecánicamente, mediante fotocopia,
grabaciones o en cualquier otro modo, sin el consentimiento previo por escrito de
GymnaUniphy N.V.
Todos os direitos reservados. Nenhuma parte desta publicação pode ser copiada,
armazenada num ficheiro de dados informático, ou divulgada, de alguma forma ou
de qualquer modo, seja electrónico, mecânico, fotocópia, gravação ou outro, sem o
consentimento prévio por escrito da GymnaUniphy N.V.
2
Vaco 500 English
User Manual Vaco 500
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 info@gymna-uniphy.com
Website www.gymna-uniphy.com
Version 1.0
June 2004
3
Vaco 500 English
Abbreviations
EMC Electromagnetic Compatibility
EL Electrode
ET Electrotherapy
Symbols on the equipment
Read the manual.
Symbols in the manual
Warning or important information.
4
Vaco 500 English
TABLE OF CONTENTS
1 SAFETY ............................................................................................ 7
1.1 P
1.2 S
1.3 M
1.4 L
2 INSTALLATION .............................................................................. 10
2.1 R
2.2 P
2.3 U
2.4 T
2.5 R
3 DESCRIPTION OF THE EQUIPMENT ............................................ 11
3.1 V
3.2 C
4 OPERATION ................................................................................... 13
4.1 P
4.2 C
4.3 T
4.4 R
URPOSE ....................................................................7
AFETY INSTRUCTIONS ...................................................7
EDICAL DEVICES DIRECTIVE ...........................................9
IABILITY ....................................................................9
ECEIPT .................................................................... 10
LACING AND CONNECTION ............................................10
SE IN COMBINATION WITH ANOTHER DEVICE ...................... 10
RANSPORT AND STORAGE ............................................ 10
ESELLING ................................................................. 10
ACO 500 AND STANDARD ACCESSORIES ......................... 11
OMPONENTS OF VACO 500 ......................................... 12
ERFORMING ELECTROTHERAPY WITH THE VACO 500 ........... 13
ONNECTING THE ELECTRODES ........................................ 14
HE WATER RESERVOIR IS FULL ....................................... 16
EFERENCE ................................................................ 16
5 INSPECTIONS AND MAINTENANCE ........................................... 17
5.1 I
5.2 M
NSPECTIONS .............................................................. 17
AINTENANCE ............................................................ 18
6 MALFUNCTIONS, SERVICE AND GUARANTEE ......................... 19
6.1 M
6.2 S
6.3 G
6.4 T
ALFUNCTIONS .......................................................... 19
ERVICE ................................................................... 20
UARANTEE ............................................................... 20
ECHNICAL LIFE TIME ................................................... 21
7 TECHNICAL INFORMATION ......................................................... 22
7.1 G
7.2 E
7.3 T
7.4 S
7.5 O
ENERAL .................................................................. 22
NVIRONMENTAL CONDITIONS ......................................... 22
RANSPORT AND STORAGE ............................................ 22
TANDARD ACCESSORIES .............................................. 23
PTIONAL ACCESSORIES ................................................ 23
5
Vaco 500 English
8 APPENDICES ................................................................................. 24
8.1 T
8.2 EMC
8.3 D
8.4 L
ECHNICAL SAFETY INSPECTION ...................................... 24
DIRECTIVE .......................................................... 25
ISPOSAL .................................................................25
ITERATURE ............................................................... 25
9 INDEX ............................................................................................. 26
10 REFERENCE EMC DIRECTIVE ..................................................... 158
10.1 G
UIDANCE AND DECLARATION ....................................... 158
6
Vaco 500 English
1SAFETY
1.1 Purpose
The Vaco 500 is intended solely for medical applications. The Vaco 500 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 500 can have physiological effects. See the
‘Safety instructions’ in the user manual of the electrotherapy
device.
• Always keep these user instructions with the equipment.
7
Vaco 500 English
1.2.2 Electrical safety
• 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.
1.2.3 Prevention of explosion
• Do not use the equipment in an area where combustible
gases or vapours are present.
• Switch off the equipment when it is not used.
1.2.4 Electro Magnetic Compatibility
• 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 500
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.
1.2.5 Accessories
• 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.
8
Vaco 500 English
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.
9
Vaco 500 English
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 500 can be used in combination with:
• The Combi 500.
• The Duo 500.
• The Combi 200L.
• The Combi 200.
• The Duo 200.
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.
10
Vaco 500 English
3DESCRIPTION OF THE EQUIPMENT
3.1 Vaco 500 and standard accessories
1
6
1. Vaco 500. See §3.2.
2. Power cord
3. Vacuum hose (4 pieces)
4. Connection cable: ET device Vaco 500 (2 pieces)
5
2
3
4
5. Sponge for vacuum electrode (4
pieces)
6. Vacuum electrode (4 pieces)
11
Vaco 500 English
3.2 Components of Vaco 500
1 2 3 4
9
8
1. LED: vaco A active
2. LED: traditional output
A
active
3. LED water reservoir
4. Vacuum intensity regulator
5. Pulse regulator
6. LED traditional output
B
active
7. Push button channel B
8. Output connectors vaco A for
vacuum electrodes
9. Output connector
A
for two-ply electrode cable
10. Indication: Read manual
11. Output connector
B
5 6 7
13
11 12
10
14 15
212019181716
for two-ply electrode cable
12. Output connectors vaco B for
vacuum electrodes
13. LED: vaco B active
14. Input connector channel A for
connection cable
15. Input connector channel B for
connection cable
16. On/off switch
17. Fuse holder
18. Connection to mains supply
19. Type plate
20. Drain hose for water reservoir
21. Air exhaust
12
Vaco 500 English
4OPERATION
4.1 Performing electrotherapy with the Vaco 500
1. Connect the Vaco 500 and the electrotherapy device to the mains
supply.
2. Connect the input connector A of the Vaco 500 to the output connector
of the electrotherapy device with the connection cable. If
A
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 500 and the
electrotherapy device to on. The LEDs from the traditional channels of
the Vaco 500 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.
13
Vaco 500 English
4.2 Connecting the electrodes
• 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.
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
vaco output connectors with
the red dot.
2 Connect the black connectors from the vacuum hoses to the vaco
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 vaco B output with the push button.
The vaco B LED is lit.
14
Vaco 500 English
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 vaco A
output connector with the red dot.
4. Connect the black connector from
the vacuum hose to the vaco A
output connector with the black
dot.
5. Connect a vacuum hose for a closed vacuum system to make a shortcircuit across the vaco 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 500.
A
B
15
Vaco 500 English
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 vaco A and short-circuit vaco
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 500.
B
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 500 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.
16
Vaco 500 English
5INSPECTIONS AND MAINTENANCE
5.1 Inspections
Component Check Frequency
Electrode cables
and electrodes
Equipment Technical safety
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.
• 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.
Damage
Insulation intact
inspection. See §5.1.1.
At least 1x per month
At least 1x per year
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.
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.
17
Vaco 500 English
5.2 Maintenance
Component Check Frequency
Vaco 500 unit Cleaning. See §5.2.1. If necessary
Vacuum
electrodes
Sponges Cleaning. See §5.2.3. After every treatment
Vacuum hoses and
water reservoir
Accessories that come in contact with the body of the patient
must be washed with pure water after the disinfection to prevent
allergic reactions.
5.2.1 Cleaning the Vaco 500 unit
1. Switch the equipment off.
2. Clean the device with a lightly moistened soft cloth.
No liquid may enter the device.
Cleaning. See §5.2.2. After every treatment
Cleaning. See §5.2.4. Weekly
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.
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.
18
Vaco 500 English
6MALFUNCTIONS, SERVICE AND GUARANTEE
6.1 Malfunctions
Component Problem Solution
Vaco 500 unit Equipment cannot be
switched on
Equipment does not react to
commands
Vacuum
electrodes
Sponges Furring Replace the sponges
Contamination by ionization See §6.1.4.
Bad conduction Replace the sponges
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.
See §6.1.1.
See §6.1.3.
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.
19
Vaco 500 English
6.1.4 Remove the contamination from the vacuum electrodes
1. Clean the vacuum electrodes. See §5.2.2.
2. Use steel wool or sandpaper for metal with fine grains (‘P 400’ or
higher) to remove the contamination.
3. Replace the vacuum electrodes if the contamination is still present.
6.2 Service
Only a technician authorised by GymnaUniphy N.V. may open the
equipment or the accessories to perform repairs. The equipment
does not contain any components that may be replaced by the
user.
Service and guarantee are provided by your local GymnaUniphy dealer. The
conditions of delivery of your local GymnaUniphy dealer apply.
If you have qualified technical personnel that are authorised by
GymnaUniphy to perform repairs, your dealer can provide diagrams, spare
parts lists, calibration instructions, spare parts and other information on
request, for a fee.
6.3 Guarantee
GymnaUniphy and the local GymnaUniphy dealer declares itself to be solely
responsible for the correct operation when:
• all repairs, modifications, extensions or adjustments are performed by
authorised people.
• the electrical installation of the relevant area meets the applicable legal
regulations.
• the equipment is only used by suitably qualified people, according to
these user instructions.
• the equipment is used for the purpose for which it is designed.
• maintenance of the device is regularly performed in the way prescribed.
See §5.
• the technical life time of the equipment and the accessories is not
exceeded.
• the legal regulations with regard to the use of the equipment have been
observed.
The guarantee period for the equipment is 2 (two) years, beginning on the
date of purchase. The date on the purchase invoice acts as proof. This
guarantee covers all material and production faults. Consumables, such as
sponges, are excluded.
20
Vaco 500 English
This guarantee does not apply to the repair of defects that are caused:
• by incorrect use of the equipment,
• by an incorrect interpretation or not accurately following these user
instructions,
• by lime deposits,
• by carelessness or misuse,
• as a consequence of maintenance or repairs performed by people or
organisations that are not authorised to do so by the manufacturer.
6.4 Technical life time
The expected life time of the equipment is 10 years, calculated from the
date of manufacture. See the type plate for this information.
In so far as possible, GymnaUniphy will supply service, spare parts and
accessories for a period of 10 years from the date of manufacture.
21
Vaco 500 English
7TECHNICAL INFORMATION
7.1 General
Dimensions Vaco 500
(w x h x d) 402 x 84 x 284 mm
Weight Vaco 500 4,4 kg
Weight including accessories 5,5 kg
Mains voltage 100 - 240 VAC, 50 - 60 Hz
Maximum power
consumption 30 VA
Safety class Class I (earthed socket required)
Insulation Type BF (floating patient circuit)
Fuses 2 x T2AL250V
Volume water reservoir ± 180 ml
Working pressure continuous
vacuum
Working pressure pulsation
vacuum
Vacuum rhythm 1,5/1,5 - 1,5/4,5 s (on/off time)
7.2 Environmental conditions
38 - 320 hPa
58 - 480 hPa
Temperature: +10 °C to +40 °C
Relative humidity 30% to 75%
Atmospheric pressure 700 hPa to 1060 hPa
7.3 Transport and storage
Transport weight 6,5 kg
Storage temperature -20 °C to +60 °C
Relative humidity 10% to 100%, including condensation
Atmospheric pressure 200 hPa to 1060 hPa
Transport classification Single piece by mail
The transport and storage specifications apply to equipment in the original
packaging.
22
Vaco 500 English
7.4 Standard accessories
Quantity Description Art. no.
1Power cord
1
100.689
2 Connection cable: ET device - Vaco 500 102.032
1
1
Vacuum hose dark grey (per 2 pces:
black/red connector)
Vacuum hose light grey (per 2 pces:
black/red connector)
102.801
102.800
2 Vacuum electrode - 60 mm (per 2 pces) 114.668
1
Sponge for vacuum electrode - 60 mm
(per 4 pces)
114.689
1 User manual Vaco 500 EN/NL/FR/DE/ES/PT 325.123
1 Safety instructions
1 This power cord has a CEE 7/7 type plug. For countries with other outlets, a different
power cord with the appropriate plug is supplied.
323.011
7.5 Optional accessories
Quantity Description Art. no.
1 Clips for 2 vacuum tubes 112.457
2 Vacuum electode - 90mm 114.686
4 Sponge for vacuum electrode - 60mm 114.687
Article numbers can change in the course of time. Check the article
numbers in the most recent catalogue or ask your dealer.
The drawings are merely indicative, no rights can be derived from them.
23
Vaco 500 English
8APPENDICES
8.1 Technical safety inspection
Vaco 500 with serial number ............. is / is not1 in good working
order
Inspection performed by: Owner:
Location: Name: Name:
Date: Initials: Initials:
1 Cross out what does not apply.
If a specific test does not apply to this equipment, place a mark in the NA
(not applicable) column.
8.1.1 Test 1: General
Ye s N o NA
1. The results of earlier safety inspections are available.
2. The logbook is present.
3. The type plate and the supplier's label are legible.
4. The housing, adjusting knobs and keys are
undamaged.
5. The power connection and power cord are
undamaged.
6. The output connectors are undamaged.
7. The electrode connectors and cables are undamaged.
8. All the operation functions work.
9. The measured output signals are correct.
10. All the alarm functions work.
24
Vaco 500 English
8.1.2 Test 2: Electrical safety test (VDE 0751)
Yes N o
1. The resistance of the safety earth is less than 0.2 Ω
2. The housing leakage current is less than 1000 µA
3. The patient leakage current is less than 5000 µA
Notes:
8.2 EMC directive
The tabel at the last pages of the user manual shows the information about
the EMC properties of the equipment. See §10.1.
8.3 Disposal
Take account of the following environmental aspects when disposing of the
equipment and the accessories:
• The basic device, the cables and the electrodes fall under small
chemical waste (or electronic waste). These components contain lead,
tin, copper, iron, various other metals and various plastics, etc. Consult
the applicable national regulations.
• Sponges contain only organic material and do not require any special
processing.
• Packaging materials and manuals can be recycled. Deliver them to the
appropriate collection points or include them with the normal
household waste. This depends on the local organisation of the waste
processing.
8.4 Literature
A literature list can be sent on request. Please contact GymnaUniphy.
25
9 INDEX
Vaco 500 English
A
Abbreviations 4
Accessories 23
safety 8
C
Cleaning 18
Connection 10
Contamination
remove 20
Contra indications 16
D
Device
cleaning 18
Disposal 25
E
Electrical safety 8
Electrodes
connection 14
Electrotherapy
perform 13
EMC 8
EMC directive 25
Environmental conditions 22
G
Guarantee 20
I
Indications 16
Inspections 17
Installation 10
L
Liability 9
M
Maintenance 18
Malfunctions 19
Medical Devices Directive 9
P
Placing 10
Prevention of explosion 8
Purpose 7
R
Replacing the fuses 19
Reselling 10
S
Safety 7
instructions 7
technical inspection 17, 24
Service 20
Sponges
cleaning 18
Storage 10
conditions 22
T
Technical information 22
Technical life time 21
Transport 10
conditions 22
V
Vacuum electrode
cleaning 18
Vacuum electrodes
place 14
Vacuum hoses
cleaning 18
W
Water reservoir 16
cleaning 18
26
Vaco 500 Nederlands
Gebruikershandleiding Vaco 500
Toestel voor het toepassen van elektrotherapie met behulp van
vacuümelektroden
Fabrikant GymnaUniphy N.V.
Hoofdkantoor Pasweg 6A
B-3740 BILZEN
Telefoon +(32) (0)89-510.510
Fax +(32) (0)89-510.511
E-mail info@gymna-uniphy.com
Website www.gymna-uniphy.com
Versie 1.0
Juni 2004
27
Vaco 500 Nederlands
Afkortingen
EMC Elektromagnetische Compatibiliteit
EL Elektrode
ET Elektrotherapie
Symbolen op het apparaat
Lees de handleiding.
Symbolen in de handleiding
Waarschuwing of belangrijke informatie.
28
Vaco 500 Nederlands
INHOUDSOPGAVE
1 VEILIGHEID .................................................................................... 31
1.1 D
1.2 V
1.3 R
1.4 A
2 INSTALLATIE ................................................................................. 34
2.1 O
2.2 P
2.3 G
2.4 T
2.5 D
3 BESCHRIJVING VAN HET APPARAAT ........................................ 35
3.1 V
3.2 O
4 BEDIENING .................................................................................... 37
4.1 E
4.2 D
4.3 H
4.4 N
OEL ....................................................................... 31
EILIGHEIDSINSTRUCTIES ............................................... 31
ICHTLIJN MEDISCHE HULPMIDDELEN ................................ 33
ANSPRAKELIJKHEID .................................................... 33
NTVANGST .............................................................. 34
LAATSING EN AANSLUITEN ............................................ 34
EBRUIK IN COMBINATIE MET EEN ANDER TOESTEL ............... 34
RANSPORT EN OPSLAG ................................................ 34
OORVERKOOP ........................................................... 34
ACO 500 EN STANDAARDACCESSOIRES ........................... 35
NDERDELEN VAN VACO 500 ........................................ 36
LEKTROTHERAPIE UITVOEREN MET DE VACO 500 ................ 37
E ELEKTRODEN AANSLUITEN .......................................... 38
ET WATERRESERVOIR IS VOL ......................................... 40
ASLAG ................................................................... 40
5 INSPECTIES EN ONDERHOUD ..................................................... 41
5.1 I
5.2 O
NSPECTIES ................................................................ 41
NDERHOUD .............................................................. 42
6 STORINGEN, SERVICE EN GARANTIE ........................................ 44
6.1 S
6.2 S
6.3 G
6.4 T
TORINGEN ................................................................ 44
ERVICE ................................................................... 45
ARANTIE ................................................................. 45
ECHNISCHE LEVENSDUUR ............................................. 46
7 TECHNISCHE GEGEVENS ............................................................ 47
7.1 A
7.2 O
7.3 T
7.4 S
7.5 O
LGEMEEN ................................................................ 47
MGEVINGSCONDITIES .................................................. 47
RANSPORT EN OPSLAG ................................................ 47
TANDAARDACCESSOIRES ............................................. 48
PTIONELE ACCESSOIRES ............................................... 48
29
Vaco 500 Nederlands
8 BIJLAGEN ...................................................................................... 49
8.1 T
8.2 EMC-
8.3 A
8.4 L
ECHNISCHE VEILIGHEIDSINSPECTIE ................................... 49
RICHTLIJN .......................................................... 50
FVOEREN ................................................................. 50
ITERATUUR ............................................................... 50
9 INDEX ............................................................................................. 51
10 REFERENCE EMC DIRECTIVE ..................................................... 158
10.1 G
UIDANCE AND DECLARATION ....................................... 158
30
Loading...