Veinoplus V.I. User manual

EN
INSTRUCTION MANUAL
HOW IT WORKS
WELCOME
INDICATIONS
VEINOPLUS® V.I. electrically stimulates the muscles to cause their contractions. VEINOPLUS® V.I.
is more eective on the calf muscle pump (“the Second Heart®”) but it can be used on other
peripheralmuscularpumps.Themuscle contractionscompressdeep andsupercialveins,as well as
lymphatic vessels and improve venous blood and lymph ows.
VEINOPLUS® V.I. is indicated for:
n Increase of blood circulation,
n Improvement of venous return,
n Reduction of venous stasis,
n Treatment of symptoms ofVenous Insuciency or Post-Thrombotic Syndrome,
n Reduction of pain sensations in legs,
n Reduction of leg swelling (edema),
n Improvement in the healing of venous ulcers,
n Decrease of restless legs and night cramps.
VEINOPLUS®V.I.isalsorecommendedfor use in situations wherethereisarisktothevenoussystem,
in order to improve or facilitate venous return such as:
n Presence of varicose veins,
n Prolonged sitting or standing (oce, long haul travel, standing jobs…),
n Lack of physical activity (walking), leg immobilisation,
n Excessive weight or obesity,
n Pregnancy,
n Family history of Venous Insuciency
Results are not guaranteed, and can vary from person to person. If symptoms persist, consult your
doctor.
Dear Customer,
We thank you for your condence inVEINOPLUS® stimulators.
VEINOPLUS® is a patented technology as a result of several years of Research & Development to
oer you a very eective yet comfortable and safe stimulation.
VEINOPLUS® V.I. is a Medical Device, according to the Medical Device Directive 93/42/EEC, that can
relieve your pain and help you in your daily life.
Please read carefully this Instruction Manual before using the device.
Ad RemTechnology and its distributors decline any responsibility for any use of theVEINOPLUS®V.I.
that does not comply with this Instruction Manual.
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EN
CONTRAINDICATIONS AND WARNINGS
WHEN TO USE VEINOPLUS® V.I.?
Daily, preferably at the end of the day, or whenever there is swelling or pain in the aected limbs.
VEINOPLUS® V.I. is especially recommended during and for 7 days after long-haul ights.
For recommended treatment modalities based upon symptoms in the legs, please refer to the table
on next page.
Themoreyouuse VEINOPLUS®V.I.,themoreeectiveitbecomes.Thereis no riskof overuse.
Each treatment lasts 30 minutes and the device stops automatically. You can have several sessions
in a row. There is no minimum rest time between sessions.
Contra-indications:
VEINOPLUS®V.I. must not be used on patients with implanted cardiac pacemakers or debrillators.
Warnings:
n If you are suering from the following conditions or in case of doubt, consult a physician before using
VEINOPLUS® V.I.:
- Venous thrombosis.
- Tendency to bleed induced by anti-clotting treatment.
n Do not apply electrodes on skin with a lesion of any kind (cancerous lesions, etc), inammation,
infection, or severe varicose veins.
n Should a skin rash or a skin burn occur, immediately discontinue use and if this persists, contact your
health practitioner.
Precautions and limitations:
n Simultaneous connection from a patient to a high-frequency electrosurgical equipment may result in
skin burns at the site of electrodes and possible damage to the stimulator.
n Application of the electrodes across the thorax may increase the risk of cardiac brillation.
n Do not use VEINOPLUS®V.I. while operating powered machinery or operating a vehicle.
n Keep out of reach of children.
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EN
RECOMMENDEDTREATMENT MODALITIES*BASED UPON SYMPTOMS
n1 session = 1 treatment = 30 mn
*Indicative modalities
Most
frequent
symptoms
Lead-in Treatment
(minimum number
of sessions)
Sustaining
Treatment
(minimum number
of sessions)
Comments
«Heavy» or Aching
Legs 1 session/day 1 session when there’s pain
Stimulate preferably at
the end of the day
Night Cramps 1 session before going
to bed
1 session before
going to bed
2 sessions in the evening
if symptoms persist
Restless Legs
(Disconfort/pain causing
an uncontrollable urge to
move the legs)
1 session before going
to bed
1 session before
going to bed
2 sessions in the evening
if symptoms persist
Acute Edema (appea-
ring occasionally or in hot
season)
- if light :
1 session/day
- if important:
2-3 sessions/day
1 session/day Sessions in the evening
are recommended
Chronic Edema
3 sessions/day for
15 days then 2 ses-
sions/day for 15 days
1 session/day Sessions in the evening
are recommended
Non Healing Ulcer
under medical
monitoring only
6 sessions (3h)/day
spread over the day
of which 2 sessions in
the evening
Ideally carry on the
same
treatment until com-
plete healing
Respect carefully the
prescribed modalities.
Electrodes can be put
under compression
garnments
Post-Thrombotic
Syndrome
Pleaser refer to the
above mentioned
symptoms
Stimulate more in
risky situations (long
sitting position,
long-haul ight,
overweight...)
Increase number of
sessions in case of
overweight
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EN
Please read the instructions and refer to the drawings from the cover page.
1 -The battery compartment is located on the back of the device. Do not use any tools to open the
battery compartment.
2 - 3 - Insert the battery into the device according to the +/- signs and close the battery compart-
ment rmly.
4 - Remove the electrodes from the plastic shields without pulling on the cable.
5- Place both electrodes on one calf if symptoms are unilateral (5a) or one electrode on
each calf if symptoms are bilateral (5b).
6 - DO NOT switch on the device before connecting the electrodes.
7 - Plug the electrodes in the cable and then plug the cable in the device.
8 - Turn on VEINOPLUS® V.I. by pressing the central key marked once.
9 - 10 - The stimulation is best performed when in sitting or semi recumbent position. SLOWLY
increase the intensity of stimulation by pushing the key, until you see and feel deep contrac-
tions of calves. The higher the intensity, the better the results of treatment with VEINOPLUS® V.I.
If contractions become too strong and/or uncomfortable you may reduce the intensity by short
pushes on the key.
11 - VEINOPLUS® V.I. will switch OFF automatically after 30 minutes of treatment but you can stop
the treatment at any time by pushing ON/OFF button.
12 - Always disconnect the electrodes after the device has been turned OFF.
13 - Remove the electrodes from the skin without pulling on the cable.
14 - Apply the electrodes onto the side ON of the plastic shields and store them in the sealed bag
provided.
HOW TO USE VEINOPLUS® V.I.?
ACCESSORIES
VEINOPLUS® V.I. is supplied with all the accessories required for an easy, safe and eective treat-
ment. These include self-adhesive skin electrodes (VEINOPLUS® PACK), one cable, one 9 V alkaline
battery and one instruction manual.
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EN
SAFETY
To ensure safe and eective usage of VEINOPLUS® V.I., please follow the instructions of this
manual. VEINOPLUS® V.I. complies with the IEC 60601-1 standard on general safety require-
ments for electro-medical devices, the IEC 60601-1-2 standard on Electromagnetic Com-
patibility and IEC 60601-2-10 standard on particular safety requirements for nerve and
muscle stimulators. The impulses from VEINOPLUS® V.I. carry a very low quantity of electricity.
This quantity is below the limits established by any international safety standards including
United States AAMI/ANSI NS-4 Standard (ANSI = American National Standard Institute).
Electrodes:
The VEINOPLUS® V.I. produces electrical impulses and delivers energy to the surface of the skin by
means of a pair of bio-compatible electrodes (VEINOPLUS® PACK).
For eective and safe treatment, use only VEINOPLUS® PACK electrodes in their sealed original
package. It is possible to use the electrodes several times. It is recommended that only one person
uses the same set of electrodes. Before applying the electrodes, the skin must be clean and free
from grease and lotion.
Used electrodes should be replaced as soon as they become dry or are no longer adhesive. When
electrodes begin losing adhesion, you can gently rub one or two drops of water onto the gel sur-
face to extend usage. Specic instructions for use and maintenance of the electrodes are included
in their packages.
Batteries:
The battery should be changed when the icon on the screen blinks intermittently. To change the
battery, follow the drawings from the cover page. Use only alkaline or rechargeable (contact
your dealer for the availability of rechargeable option) 9 V batteries type 6LR61 (or equivalent
e.g. 6LF22, AM6, MN1604 or GP1604). Don’t use rechargeable lithium batteries. If other batteries
are used, the VEINOPLUS® V.I. may temporarily stop functioning.
Precautions concerning the handling of batteries:
n Do not recharge alkaline batteries.
n Do not short-circuit the batteries by contact with metallic objects.
n Do not dispose of batteries in re.
n Store batteries in temperatures ranging from +5 to +27 °C.
n When your device is not used for a long period of time, remove the battery.
n Waste batteries must be disposed properly, to preserve the environment.
Cable:
Use only cable supplied withVEINOPLUS®V.I. device.
Cable is 135 cm long.
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EN
VEINOPLUS® V.I. is an internally powered (9 V battery) electrical muscle stimulator that delivers
specic low frequency and low voltage stimulation impulses.The device is intended for continuous
use and the degree of protection against ingress of water is IPX0. Input power is below 0.5 W and
output power ofVEINOPLUS® V.I. is below 0.05 W.
Output parameters of VEINOPLUS® V.I.:
n The voltage waveform of theVEINOPLUS® V.I. is rectangular monopolar and balanced with ZERO net
d.c. component.
n The time duration of output impulses ranges from 25 to 240 microseconds.
n During impulses, the instantaneous output voltage reaches a peak value of 50Vp ± 5%, when loaded
with impedance in a range from 250 Ω to 10,000 Ω.
Maximum ratings of theVEINOPLUS® V.I. output when loaded with 500 Ω resistance:
The current intensity may reach a peak value of 100 mA ± 5 % during impulses.
The waveform is modulated in a special pattern resulting in muscle contractions ranging from 2
to120 beats-per-minute.
TECHNICAL DESCRIPTION
ENVIRONMENTAL : CONDITIONS FOR USE, STORAGE AND TRANSPORT
n VEINOPLUS® V.I. need special precautions regarding EMC and need to be installed and put into
service according to the EMC information provided in the Instruction Manual.
n Portable and mobile RF communications equipment can aect medical electrical equipment.
n The use of accessories, electrodes and cables other than recommended by Ad Rem Technology
may result in increased Emissions or decreased Immunity of VEINOPLUS® V.I.
n VEINOPLUS® V.I. does not produce excessive electromagnetic interference (EMI) in test accord-
ing to IEC 60601-1-2 standard. It may be used during air travel but not during take-o and
landing. (see EMC tables)
n VEINOPLUS® V.I. should not be used adjacent to or stacked with other equipment.
n Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy equipment may
produce instability in the stimulator output (see EMC tables)
n VEINOPLUS® V.I. is not intended for use in sterile environments.
n VEINOPLUS® V.I. and accessories must be used/ stored/ transported in temperatures from +5 to
+27°C and with Relative Humidity (RH) 0~50%, pressure 850 to 1060 hPa and altitude <3000m.
n At the end of their life the VEINOPLUS® V.I. devices should be disposed of properly
with respect to environmental regulations.
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EN
INTERNATIONAL WARRANTY
TROUBLESHOOTING
VEINOPLUS® V.I. is manufactured according to high-quality standards.
VEINOPLUS® V.I. is guaranteed for 12 months from the date of the purchase against any manu-
facturing defect, except for the battery, glass breakage, normal wear and tear of electrodes and
cable, as well as any damage due to abusive handling or removing parts of VEINOPLUS® V.I. by
unauthorised third parties.
This International Warranty does not aect your consumer statutory rights under applicable local
Laws, nor your rights against the seller arising from your purchase transaction. Please contact Ad
Rem Technology or your local distributor.
Problem: Device non-functioning, blank screen.
Solution: Insert a fresh alkaline battery.
Problem: Screen functioning but there is no sensation in legs.
Solution: Check that both electrodes are correctly applied to the skin and that both are connected
to the device. Increase the intensity of stimulation by single short pushes on the key.
Problem: Stimulation is less eective or less pleasant.
Solution: Check that your skin is clean and free from grease and lotion. Improve stimulation
eectiveness and comfort by gently rubbing one or two drops of water onto the gel surface. If the
problem persists, you need to change the electrodes.
Problem: When electrodes are applied to each leg i.e. one electrode per leg, there is a weaker
sensation in one leg compared to the other, or the sensation is absent in one leg, but not in the
other.
Solution: Calf muscles do not necessarily respond symmetrically. Continue treatment until the less
responsive leg starts to level out with the other. If one leg is still not responsive, while the other has
neared maximum bearable stimulation, please stop stimulation and consider stimulating each leg
individually. That means one session with both electrodes on one calf then another session with
both electrodes on the other.
If your problem is not solved by following the above instructions, please contact Ad Rem Technol-
ogy or an authorised representative.
n VEINOPLUS® V.I. requires neither routine maintenance nor calibration. If necessary, the device can be
cleaned by alcohol-impregnated wipes.
n The electrodes VEINOPLUS® PACK and the cable supplied with VEINOPLUS® V.I. can be replaced
through your local VEINOPLUS® distributor.
n All services are handled either by Ad RemTechnology or by authorised representatives.To obtain this
service, please contact your vendor.
SERVICE
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EN
DEFINITION OF SYMBOLS ON THE DEVICE
Follow instructions for use
The device has one applied part type BF (electrodes)
Adjustments of intensity buttons
ON/OFF switch button
This symbol means that VEINOPLUS® is in conformity with the requirements of the
Medical Device Directive 93/42/EEC, 0535 is the number of notied body.
KEY TO DIAGRAM ON INTERNAL COVER PAGE
1ON / OFF 4Remaining time 7Cable jack
2Intensity control 5Battery replacement
display 8Electrodes
3Intensity of stimulation 6Usage counter 9Positioning of electrodes
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NÁVOD K POUŽITÍ
JAK PŘÍSTROJ PRACUJE
VÍTÁME VÁS
INDIKACE
VEINOPLUS® V.I. elektricky stimuluje svaly, což způsobuje jejich kontrakci. VEINOPLUS® V.I. je
efektivnější na lýtkové svalové pumpě (“Druhé srdce Heart®”), ale může být použit i na jiných
periferních svalových pumpách. Svalové kontrakce stahují hluboké a povrchové žíly a lymfatické
dráhy a zlepšují tak proudění venózní krve a lymfy.
VEINOPLUS® V.I. je indikován pro:
n Zvýšení cirkulace krve,
n Zlepšení venózního návratu,
n Redukci venózní zástavy,
n Léčení symptomůVenózní Insucience nebo Post-trombolického syndromu,
n Redukci citlivosti nohou na bolest,
n Redukci otékání nohou (edemů),
n Zlepšení léčby bércových vředů,
n Snížení pocitu neklidných nohou a nočních křečí.
VEINOPLUS® V.I. je také doporučován pro používání v situacích, které jsou rizikové pro venózní
systém, jako jsou:
n Přítomnost varixových žil,
n Dlouhé sezení nebo stání (kancelář. nebo stojavé práce, dlouhé cestování),
n Nedostatek fyzické aktivity (chůze), znehybnění nohou,
n Nadměrná váha nebo obezita,
n Těhotenství,
n Rodinné dispozice venózní insucience
Účinky nejsou garantovány u všech a mohou se od osoby k osobě lišit. Pokud symptomy přetrvávají,
konzultujte to s Vašim lékařem.
Vážený zákazníku,
děkujemeVám za nákup přístrojeVEINOPLUS® .
VEINOPLUS® je patentovaná technologie, která je výsledkem řady let výzkumu a vývoje a nabízí
Vám velmi efektivnía, pohodlnou a bezpečnou stimulaci dolních končetin.
VEINOPLUS®V.I. je zdravotnický přístroj podle Medical Device Directive 93/42/EEC, který ulevuje od
bolesti a zlepšuje kvalitu života.
Před zahájením používání si pečlivě přečtěte, prosím, tento Návod k použití.
Ad RemTechnology and its distributors decline any responsibility for any use of theVEINOPLUS®V.I.
that does not comply with this Instruction Manual.
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KONTRAINDIKACE A VAROVÁNÍ
KDY POUŽÍT VEINOPLUS® V.I.?
Denně, převážně na konci dne nebo kdykoliv při otocích nebo bolesti nohou.
VEINOPLUS® V.I. se zvlášť doporučuje používat během dlouhého letu a týden po něm.
Varianty způsobu použití podle druhu symptomů jsou uvedeny v tabulce na následující stránce.
Čím častěji VEINOPLUS® V.I. budete používat, tím efektivnější léčba bude. Neexistuje
žádné riziko nadměrného používání. Každá aplikace trvá 30 minut a přístroj se po uplynutí doby
automaticky vypne. Můžete provádět několik aplikací za sebou bez jakékoliv nutné přestávky mezi
nimi.
Kontraindikace:
VEINOPLUS® V.I. nesmí být používán u pacientů s implantovaným kardiostimulátorem nebo de-
brilátorem.
Varování:
n Pokud trpíte následujícími potížemi nebo v případě pochybností, konzultujte použitíVEINOPLUS® V.I.
s Vašim lékařem:
- Venózní thrombóza.
- Zvýšená krvácivost v důsledku antikoagulační léčb.
n Nepřikládejte elektrody na pokožku s jakýmkoliv poškozením (rakovinné léze, atd.), zánětem, infekcí
nebo s vážnými křečovými žilami.
n Pokud se objeví podráždění nebo popálení pokožky, okamžitě ukončete aplikaci, a pokud toto
přetrvává, kontaktujte svého obvodního lékaře.
Opatření a omezení:
n Současné spojení pacienta s vysokofrekvenčním elektrochirurgickým přístrojem může mít za násle-
dek popálení kůže v místě elektrod a poškození stimulátoru.
n Aplikace elektrod na hrudníku může zvýšit riziko srdečních brilací.
n NepoužívejteVEINOPLUS®V.I. , pokud ovládáte nějaké zařízení nebo řídíte vozidlo.
n Udržujte přístroj mimo dosah dětí.
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