Globus Wintec Easy Tens User Manual

ELECTROSTIMULATOR

EE AA SS YY TT EE NN SS

USER MANUAL GEBRAUCHSANWEISUNG

MANUAL DE UTILIZACION

MANUEL D’UTILISATION

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0

SUMMARY

INDEX

-Accessories 2

-Precautionary measures 3

-Palm technical features

-Electrode and battery removal

-Description of the Palm 6

-Display 7

-How to use the Palm 8

-First use

-How to pause the program

-Automatic function

-Automatic switching-off

-Electrode contact

-Empty battery

-Memory function

-Intensity of stimulation

-Special functions

-Keyboard lock key

-Battery replacement 10

-How to connect the cables 10

-How to place the electrodes 10

-Common questions 11

-Guarantee terms 12

English

ENGLISH

This product as been manufactured by:

SAVIALtd. mail: info@savie.com Tel.: +852-23432318

This product has been manufactured according to the technical regulations in force and it has been subjected to certifications according to 93/42/CEE directiv for medical devices in order to assure the product’s security. The user must follow all prescriptions and restrictions shown in the operating manual in order to keep the maximum security level of the product. The manufacturer declines all responsibility for every different use from what indicated in this operating manual. All complete or partial reproductions of texts and/or pictures of this operating manuals made by any electronic or mechanic equipments are strictly forbidden without written permission of the manufacturer.

0197

This symbol warns you to read the operating instruction prior to use

Accordance with 72/23/CEE low voltage and 89/336/CEE , 93/42/CEE with the medical device directive requirement. The number of the notified authority is 0197

This symbol means that this device is a BF pattern

Die Gerät ist aufgebauet von:

SAVIALtd. mail: info@savie.com Tel.: +852-23432318

Die Gerät ist aufgebauet in Überainstimmung mit den EU-Verordnung über die medizinische Geräte (93/42/CEE), die versichern die Sicherheit den Produkt. Zu erhalten die Höchststand der Sicherheit, der Benutzer musst Bezug auf den Nutzen nehmen. Der Hersteller ist verboten die Reproduktion von der Texte und der Foto dieses Nutzen ohne die HerstellerGenehmigung.

0197

Dies Symbol bedeutet Actung, schlagen in den Dokumenten nach

Es ist normgereicht mit dem Verordnungen 72/23/CEE über Niederspannung, 89/336/CEE über die elektromagnetische Vereinbarkeit und it dem Verordnung über die medizinische Geräte (93/42/CEE) die versichern die Sicherheit den Produkt.Der Nummer von Köperschaft ist 0197.

Dies Symbol bedeutet Gäratmodel BF

Este producto está:

SAVIALtd. mail: info@savie.com Tel.: +852-23432318

El equipo fue construido en conformidad a normativas tecnicas vigentes, y fue sometido a certificaciones a sentidos de la directiva 93/42/CEE sobre dispositivos medicos.Para mantener el maximo nivel de seguridad, el usuario debe utilizar el equipo respetando las prescripciones y los limites de empleo del manual de uso.El productor rechaza cada responsabilidad en merito al uso diferente del que se indica y prescribe en el presente manual.Sin el permiso escrito del productor se prohibe la reproducción tambien parcial en cualquier forma o con cualquier metodo electrónico o mecanico de los textos y/o fotos contenidos en este manual.

0197

Dies Symbol bedeutet Actung, schlagen in den Dokumenten nach

Dies Symbol bedeutet Gäratmodel BF

Ce produit est réalise par:

SAVIALtd. mail: info@savie.com Tel.: +852-23432318

L’appareil a été construit en conformité aux normes techniques en vigueur, et a été soumis à certification selon la directive 93/42/CEE sur les dispositifs medicaux. Puor maintenir le niveau maximum de suretée l’utilisateur doit utiliser l’appareil dans le respect des prescriptions et des limites d’emploi du manuel d’utilisation. Le producteur décline toute responsabilité en cas d’utilisation difforme de ce qui est indiqué et prescrit dan ce manuel.Sans l’autorisation écrite par le producteur toute reproduction, meme partielle sous toute forme ou à l’aide de moyens électroniques ou mécaniques des textese et des photos contenues dans ce manuel est interdite.

0197

Attention: line les instructions annexes

Conforme aux directives 72/23/CEE sur la basse tension et 89/336/CEE sur la compatibilité électromagnétique, à la directive 93/42/CEE concernant les dispositifs médicaux, par l’Organiseo Notifié Cermet N° 0197, à garantie de lasuretée du produit.

Parties appliqées BF

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0

PRECAUTIONARY MEASURES

Contraindications

-Do not stimulate the neck region (carotid sinus).

-Patients who have a demand type cardiac pacemaker.

-Stimulation should be not used on cancer patients (previous permission received by the oncologist).

-Do not stimulate the cerebral zone.

-Do not use on undiagnosed pains until aetiology is established.

-Do not use on sores and dermatological diseases.

-Do not use on acute traumas.

-Do not stimulate recent cicatrix.

-Do not use during pregnancy.

-Do not use driving car.

-It is absolutely forbidden to stimulate the ocular and genital zone

-It is also forbidden the use of the stimulator in the water ( it is not protected against the water seepage). Not to use the stimulator in environment where combustible gas, inflammables, or oxygen are present.

-It is also required to use with caution in case of capillary fragility because an excessive stimulation could cause the break of more quantity of capillaries. Anyway it is always preferable to contact your doctor befo re using.

Adverse possible effects

Skin irritation can occur in rare case. In case of allergic reactions by the use of gel, stop the treatment and contact the specialist doctor. If during the stimulation treatment tachycardia or extrasistolia should appear, it is better to stop the treatment the sensation will pass immediately.

Precautions for using

-Do not make any modifications or repairs by yourself. Authorized centres can only execute the repairs.

-Do not give a shock to the product by clashing, overturning or shaking. It may cause a trouble or accident in a long run although no immediate trouble occurs.

-Store the electro stimulator at a place free from a splash or water. Avoid installing at places subject to undue humidity, temperature, dust or places exposed to direct sunbeam.

-Do not use thinner, gasoline, kerosene, cleaning powder or chemicals; for cleaning the machine it is sufficient a soft duster

-Take away the battery from the electro stimulator in case of prolonged no use.

-After a long period of no use it is advisable to check the correct working.

-For cleaning the machine and the cables, it is sufficient a soft duster lightly humid.

This symbols warns you to read the operating instructions prior to use

ACCESSORIES

Accessories on request

-Ball pen

-Kit splitter (2 connectors + 2 connection cables) (4 channels with 8 electrodes)

-Conductive band for legs

-Face electrodes

-Y cables

-Gel

Accessories

-Electro stimulator

-Carry case

-2 connection cables

-Case of 4 reusable adhesive electrodes (5 x 5 cm)

-Case of 4 reusable adhesive electrodes (5 x 9 cm)

-3 battery stylos 1,5 V AAA

-Operating manual

This stimulator is supplied complete of cables and electrodes. When you open the packing verify that the simulator equipment is complete. If some of the above mentioned accessories are missing, you should immediately contact the shopkeeper. Also check the stimulator and electrodes integrity. Electrodes: The electrodes are usable by only one user they are self-adhesive and do not need gel. The electrode cable is female. They are branded CE complied with MDD 93/42/EEC requirements. All the information can be subject to changes without notice.

The symbols mean that the apparatus is in accordance with medical CE requirements type BF.

English

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0

TECHNICAL FEATURES

Number of channels: 2. Out current: 90 mA Wave form: Square, biphasic, symmetrical, compensated impulse Running frequency: 1-110Hz. Impulse amplitude: 50-300 µs. Supply: 3 batteries of 1,5V AAAtype LR03. Caution for storage and shipping: Temperature: 10-40°C. Air humidity: 20-65%. Air pressure: 700hPa-1060hPa. Weight: 95 gr. Classification: Power supply type BF. Certification: Certificate CE MDD (Medical Device Directive)

The name of producer is reported in the last page.

Device removal

Don't throw the battery or electrodes out but recycle or get rid of them appropriately following the removal rules in force in your country.

Warnings

- The stimulator must be used only for transcutaneous neuro-stimulation.

- The neurostimulation apparatus should be used only under the continued supervision of a physician.

- The stimulator should be only used with skin electrodes intended for nerve and muscle stimulation.

- The user must keep the device out of reach of children.

- Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when stimulation is in use

- Stimulus delivered by this device may be sufficient to cause electrocution: Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.

- Do not use the apparatus in case of any health problem without consulting your doctor.

- In case of damage of the covering apparatus, this has to be replaced.

- It is advisable not to use the apparatus together with other electronic equipment above all those used for support of vital functions.

- The device must be used only by person with mental competence.

- Do not use the stimulator near short wave devices.

Use destination

Read the operating manual carefully in order to avoid to carry out installation, use and maintenance non adequate that could damage the apparatus the operator and the user. The stimulators are used in the following operating enviromment and field:

- home;

- surgeries hospital;

- physiotherapic surgery;

- rehabilitation centres;

- treatments of pain in general

- in any type of sequential electro stimulation,

- Aesthetic and sports use,

The use of the stimulator is allowed to patients (rightly informed about the methods), doctors and paramedic. The presence of clinic stimulation, makes this product a medical device. The certification cover the clinic applications.

English

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0 It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0

DISPLAY

The device has a big display, which continuously gives information about the different parameters in use.

A Timer:

Shows the remaining time in minutes. The timer zone consists of a circular graph representation, which moves during the performance.

B Performance indicator:

The figures of small man and impulses, indicate the correct execution of the program. The represen ted graphic impulses are animated in different ways for each program. When this zone is light, it means that a program is in progress.

C Intensity graphic indicator:

The graphic bar shows the intensity level in use.

D Intensity numerical indicator:

Shows the used intensity level included from 0 to 20 scale.

E Program indicator:

Shows the selected program.

F Lock key indicator:

It shows that the keyboard is locked except for the ON/OFF switch.

G Battery indicator:

The indicator lightens when the batteries are almost empty.

DESCRIPTION OF THE PALM

ON / OFF key

-Press for three seconds for turning the stimulator ON.

-Press for three seconds for turning the stimulator OFF

-This switch can be used during the treatment as a stop button

LOCK key

-To lock all keys, except for the ON / OFF key, press for 3 seconds.

-To unlock the keys press for 3 seconds again.

Display

-Indicates mode, parameters etc.

Program key

-Press this key to select the program.

Intensity key of the right

channel

-Press the key with the arrow to increase the out intensity of the right channel.

-Press the key with the arrow to decrease the out intensity of the right channel.

Intensity key of the left

channel

-Press the key with the arrow to increase the out intensity of the left channel.

-Press the key with the arrow to decrease the out intensity of the left channel.

English

How to pause the program

You can pause the program by pressing the ON / OFF switch. Start the stimulation by pressing the On / OFF switch again. The program continues where the stimulation was shut off.

Automatic functions Automatic Switching-off

If the electric stimulator is not in use for more than 5 minutes and the intensity in both channels is on 0, the stimulator automatically switches-off.

Electrode contact

If the electrodes are not correctly placed on the skin or the cables are not well connected, the intensity of channels is automatically shut off to 0. In case the electrodes are not correctly placed before starting a treatment, it is not possible to increase the channel intensity. This is a security measure to preserve the user from unpleasant possible effects.

Empty battery

The battery indicator lights up on the display when the batteries are almost empty. As long as stimulation feels the same as usual you can continue the treatment. It is time to replace the batteries when stimulation starts diminishing or the stimulator shuts off.

Memory function

The electric stimulator keeps on the memory the last performed program which is repurposed when you turn on the stimulator again. The memory function takes back the unit to the first program every time you change the batteries.

Intensity of stimulation

The intensity value for obtaining a special contraction is completely subjective. It can depend on a series of factors like as the electrode position, the adipose stratum, the perspiration etc. For these reasons the same current intensity value can give different sensations from a person to another from a day to another or furthermore you could feel more contraction on the left limb rather than the right one. You have to regulate it on the bases of your sensations.

Special Functions Keyboard lock key

When you have reached the wished intensity level, you can lock the keys except for the ON / OFF switch, by pressing the LOCK key for 3 seconds. This function will avoid you the accidental use of switches during the treatment. The keyboard lock is released when the key is pressed for three seconds again.

Note: You cannot change the intensity value during the rump up and ramp down in all intermittent programs, which foresees cycles of work and recovery.

First use

1. Attach the electrodes to the cable and place them on the skin.

(See Placement of Electrodes chapter of this manual).

2. Turn the stimulator ON by pressing for three second the

ON/OFF key. The stimulator automatically shows the last used program. The intensity indicator is positioned on 0 in both channels.

3. Select the program you want to perform pressing the Pkey.

4. Increase the used channel intensity by pressing the arrow

of (L) switches Increase the intensity until the wished level, maintaining a pleasant feeling. To decrease the intensity press the arrow .

5. Increase the used channel intensity by pressing the arrow

of (R) switches Increase the intensity until the wished level, maintaining a pleasant feeling. To decrease the intensity press the arrow .

6. Every time you want to turn-off the stimulator, press the

ON / OFF key. It can be used as an emergency button.

NOTE: Each program has a predefined duration time. The intensity resets to 0 when the program ends.

HOW TO USE THE PALM

English

COMMON QUESTIONS

Why does the intensity return immediately to 0 when increasing its value?

The unit has a control of current supply. In case the circuit is open the intensity is automatically shut off. It is therefore necessary, before starting any treatment, to be sure that the cables are well connected and the electrodes completely placed on the skin.

What to do when the discharged battery indicator appears?

You can continue your stimulation until it starts diminishing; then turn off the unit, disconnect the electrode cables and change the batteries.

Is it possible to use the electric stimulator during the menstrual cycle?

Possible interferences, like anticipations, delays, accentuations or reductions of the cycle can be subjective and variable. It is however advisable to avoid treatments in the abdominal zone during the cycle.

Is it possible to use the electric stimulator during lactation?

Until now it has not found collateral effects in relation to the electric stimulator use during the lactation. It is however advisable not to treat the thoracic zone.

Does the presence of dermatological diseases like psoriasis, urticaria, etc. prevent the electric stimulator use?

Yes, it is advisable not to treat epidermic zones, which present important dermatological diseases.

How long after is it possible to see the first results?

The aesthetic results obtained are always subjective. It is however possible to state that you can achieve good results about tonicity after 15 days with 3 or 4 sessions a week; for lypolisis and drainage treatment it is necessary at least 40 days. Better and speeder results are obtained if treatments are combined with a good physical activity and a correct life style.

Battery replacement

Shut off the stimulator. Remove the battery cover by sliding it downwards and take out the batteries. Placed 3 alkaline batteries of 1,5V AAA type LR03 and close the cover. Make sure that the new batteries are correctly placed with respect to the polarity (note marks for + and-)

Electrode and battery removal

Don't throw the batteries or electrodes out but recycle or get rid of them appropriately following the removal rules in force in your country.

How to connect the cables

It is possible to use one or two cables depending on use of one or two channels. Connect the cable connector to the relative output placed on the inferior part of the unit. The outputs are exactly below the correspondent channel (left or right).

How to place the electrodes

Remove the electrodes from the original wrapping and connect the cable plugs to them. Place the electrodes on the skin following the images present in this manual. At the end of the treatment put back the electrodes in their special seat. Note: The new electrodes have a hermetic wrapping, therefore check that they are new and supplied together with the unit.

ATTENTION: Don't remove the electrodes when the unit is working.

English

SOMMAIRE

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0

GUARANTEE TERMS

This product is warranted to the first user for a 24-month period from the purchase date against material defects or manufacturing, provided that it is used properly and maintained in the normal efficiency conditions.

To enjoy the warranty service, the user must observe the following warranty articles: 1-The products must be delivered for repairing by the User in their original packaging, the expenses are charged to the

User. 2-The product warranty depends on the presentation of fiscal document (cash voucher, fiscal receipt or selling invoice)

and certifying the purchase date of the product. 3-The repairing will not have effect on the original date of warranty expiration and will not mean the renewing or exten-

sion of the warranty. 4-When during the repairing will not be found any defect, will be in any case charged the expenses related to the chec-

king time. 5-The warranty doesn't have effect in case of damages by bits, falls, improper or incorrect use, not original external

supply, accidents, alterations, changes / removal of warranty seals and / or product infringement. The warranty doesn't cover the damages caused during the transportation due to the use of inadequate boxing (see art. 1).

6-The warranty doesn't cover the impossibility of using the product, other occasional or consequential expenses or other purchaser expenses.

ATTENTION: Before returning the machine to be repaired, it is recommended to carefully read the user manual instructions. In case of device breakdowns contact the shopkeeper before. The fabricant can make at any moment all the necessary modifications to improve the product aesthetic and quality.

Manufactured by:

DOMINO s.r.l. Tel. +390438793052 Fax +390438796463 info@domino.tv.it

Tuote reproduction ou copie est interdite sans l’autorisation du producteur. REV. FRA. 3.0

FRANÇAIS

SOMMAIRE

- Accessoires 14

- Précautions d’emploi 15

- Caractéristiques techniques de l’appareil palmaire 17

- Ecoulement des électrodes et des piles

- Description de l’appareil palmaire 18

- Description du display palmaire 19

- Guide pour une simple utilisation du palmaire 20

- Première utilisation

- Mettre en pause un programme

- Fonctions automatiques

- Eteignement automatique

- Relèvement du contact électrique

- Relèvement de batterie déchargée

- Fonction de mémoire

- Intensité de stimulation

- Fonctions spéciales

- Bloquage des touches

- Positionnement des batteries 22

- Connexion des cables 22

- Application des électrodes 22

- Questions courantes 23

- Conditions de garantie 24

Français

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PRECAUTIONS D’EMPLOI

Contre-indications

- Stimulation de la partie antérieure du cou (sein carotidien).

- Porteurs de stimulateur cardiaque (pace maker).

- Malades de tumeur (consulter le médecin).

- Stimulation de la région cérébrale.

- Utilisation sur douleurs d’origine inconnue.

- Plaies et pathologies dérmatologiques.

- Traumatismes aigus.

- Stimulation sur cicatrices récentes.

- Femmes enceintes.

- Pendant la conduite de véhicules.

- L’utilisation de l’électrostimulateur dans la zone oculaire et génitale est absolument interdite.

- Utilisation de l'electrostimulateur dans l’eau (l'appareil n’est pas protégé contre la pénetration des liquides) et dans

milieux avec gas combustibles, vapeurs inflammables ou dans des chambres oxygenées. Il est conseillé de recourir à l’electrostimulation avec beaucoup d’attention en cas de fragilité des capillaires, vu qu’une stimulation eccessive pourrait ammener à la rupture d’un nombre majeur de cappillaires. Il est toujours préférable consulter un médecin avant de commencer un traitement.

Possibles effets indésirables

Cas isolés d’irritation cutanée peuvent se vérifier en sujets avec une sensibilité épidermique particulaire. En cas de réaction allergique au gel des électrodes suspendre le traitement et consulter un médecin spécialiste. Si en cours de traitement se présentent des signes de tachicardie ou extrasystolie, il est opportun interrompre l’electrostimulation: tout reviendra à la normalité.

Entretien et nettoyage de l’appareil

- Ne pas intervenir, ouvrir l’appareil. Les réparations peuvent etre effectuées seulement par un centre specialisé et autorisé.

- Pour le nettoyage de l'appareil il suffit d’une serviette souple et légerement humide.

- Eviter les chocs violents qui pourraient endommager l’appareil et déterminer des malfonctionnements meme pas dans l’immédiat.

- Tenir l’électrostimulateur loin de jets d’eau, sources de chaleur, poussière, milieux humides et en directe exposition aux rayons du soleil.

- Ne pas nettoyer l’appareil à l’aide de diluents, gazole, chérosène, alchool , eau ou produits chimiques.

- Après une longue période d’inutilisation, vérifier le correct fonctionnement de l’ appareil.

- En cas de détéroriation du boitier dell'appareil, celuici va substitué et ne plus utilisé.

- On déconseille l’utilisation de l'appareil en concommitance avec d’autres appareils électroniques, en particulier d’instruments employés pour le soutien des fonctions vitales.

Ce symbole signifie “Attention, consulter les documents”

ACCESSOIRES

Dotation

- Electrostimulateur palmaire

- Sac pour le transport

- 2 cables de connection

- Enveloppe électrodes 45 X 45 mm.

- Enveloppe électrodesi 45 X 90 mm.

- 3 Batteries stylo 1,5 V AAA

- Manuel d’instructions

Accessoires non en dotation (supplément payant)

- Stylo pour la recherche des points poteurs

- Kit Splitter (2 connecteurs + 2 cables de connection) (4 canaux-8 électrodes)

- Bandes conductrices pour jambes

- Electrodes pour le visage

- Kit cables dédoubeurs en Y

- Gel

L'appareil pour l’electrostimulation est fourni avec cables et électrodes pour l'utilisation: pour autant, une fois l’emballage ouvert , vérifier que la dotation de base soit complète. Au cas où quelque élément manquerait, contacter immediatement le magasin autorisé où à été effectué l’achat. Controler à vue l’intégralité de lìappareil et des électrodes. Electrodes: Les électrodes en dotation sont utilisables par une seule personne, autoadhésifs, avec Gel et fiche femelle. Marqués CE aux sens de la directive 93/42/ CEE dispositifs médicaux. Toutes les informations fournies peuvent etre sujettes à modification sans préavis.

Les marques indiquent que l’appareil est à norme CE medicale type BF

Français

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Globus Wintec Easy Tens User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual