Wintec Easy Tens User manual

ELECTROSTIMULATOR
EEAASSYYTTEENNSS
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 1
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:
SAVIA Ltd.
mail: [email protected]
Tel.: [phone]
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 restric-
tions 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 directi-
ve requirement. The number of the notified authority is
0197
This symbol means that this device is a BF pattern
Die Gerät ist aufgebauet von:
SAVIA Ltd.
mail: [email protected]
Tel.: [phone]
Die Gerät ist aufgebauet in Überainstimmung mit den EU-Verordnung über die medizini-
sche Geräte (93/42/CEE), die versichern die Sicherheit den Produkt.
Zu erhalten die Höchststand der Sicherheit, der Benutzer musst Bezug auf den Nutzen neh-
men. 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:
SAVIA Ltd.
mail: [email protected]
Tel.: [phone]
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 man-
tener el maximo nivel de seguridad, el usuario debe utilizar el equipo respetando las pre-
scripciones y los limites de empleo del manual de uso.El productor rechaza cada respon-
sabilidad 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
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
Ce produit est réalise par:
SAVIA Ltd.
mail: [email protected]
Tel.: [phone]
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 pre-
scriptions 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 médi-
caux, 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
2It 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 sen-
sation 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 humi-
dity, 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 equip-
ment is complete. If some of the above mentioned accessories are missing, you should immediately contact the shopkee-
per. 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.
3
English

It is forbidden the reproduction and the copy of this manual without written permission of producer. REV. ING. 3.0
4It 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 AAA type 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 stimula-
tion 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.
5
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 7
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.
6
DESCRIPTION OF THE PALM
ON / OFF key
-Press for three seconds for turning the stimu-
lator ON.
-Press for three seconds for turning the stimu-
lator 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, parame-
ters 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 chan-
nel.
-Press the key with the
arrow to decrease the out
intensity of the right chan-
nel.
Intensity key of the left
channel
-Press the key with the
arrow to increase the out
intensity of the left chan-
nel.
-Press the key with the
arrow to decrease the
out intensity of the left
channel.
English