Med-Fit 3 Plus User manual

Patient Instructions & User Manual
Instrucciones para el paciente y manual del usuario
Patientenanweisungen & Benutzerhandbuch
Instructions pour le patient et manuel d’utilisation
Tel: [phone] email [email protected]
Med-Fit 3 Plus
medfit
2460
Alivio del dolor - Máquina TENS - Estimulación muscular.
Schmerzlinderung - TENS Machine - Muskelstimulation.
Soulagement de la douleur - Machine TENS - Stimulation musculaire.
Med-Fit 3 Plus (Comfy Stim EV806)
Pain Relief
TENS Machine
Muscle Stimulation.
Med-Fit 3 Plus (Comfy Stim EV806)

2
Contents
WHAT’S IN THE BOX ...................................................................................................... 3
STEP BY STEP GUIDE .................................................................................................... 4
GENERAL DESCRIPTION ................................................................................................ 6
INTRODUCTION TO TENS ............................................................................................... 6
ADJUSTING THE CONTROLS IN TENS MODE................................................................... 7
INTRODUCTION TO EMS .............................................................................................. 10
ADJUSTING THE CONTROLS IN EMS MODE.................................................................. 11
TENS CAUTIONS.......................................................................................................... 14
EMS CAUTIONS........................................................................................................... 15
WARNINGS AND CAUTIONS ........................................................................................ 16
SAFETY-TECHNICAL CONTROLS .................................................................................. 17
MALFUNCTIONS.......................................................................................................... 17
CONFORMITY TO SAFETY STANDARDS ....................................................................... 17
GRAPHIC SYMBOLS..................................................................................................... 18
medfit
Skin Patch Test
It is recommended that you carry out a patch test before applying your rst treatment, To do this, remove one
electrode from the packaging and place it on a part of your body that is both visible and easy to inspect.
After 30 minutes, remove the electrode and inspect the area for any redness or irritations. If no change is
noticed, proceed with your rst TENS treatment following the User Guide and Instructions provided. If skin
irritation has been noticed, we recommended the use of sensitive gel electrodes.

3
12
4
3
1
5
1. TENS unit
2. User manual
3. 2 9v Battery
4. 16 5x5 self-adhesive electrodes.
5. 2 Patient Leads
Carry Case
What’s in the box?

4
To access the controls, open the front cover (opens from the left hand side see Fig B) for control
functions.
Step by Step Guide
On/Off and intensity controls
Up and
down keys
Set Button
Mode button

5
Install the PP3 9V battery supplied into the compartment at the rear of the device.
Step by Step Guide
To switch on the device turn either one of the intensity controls at the top of your unit
You are now ready to use your device. It is recommended to now turn off the device and connect
the patient leads to the sockets as shown in Fig C.
Depending on the condition and treatment area, you may use any number of electrodes up to a
maximum of 4 electrodes and 2 channels.

6
GENERAL DESCRIPTION
The Med-Fit 3 Plus TENS/EMS is a battery operated pulse generator that sends electrical impulses electrodes
to the body and reach the nerves and underlying muscle group. This unit is a combination stimulator of
TENS and EMS which can be used for muscle stimulation and pain relief. The device is provided with four
controllable output channels, each independent of each other. An electrode pair can be connected to each
output channel. The intensity level is controlled by press buttons.
INTRODUCTION TO TENS
EXPLANATION OF PAIN
Pain is a warning system and the body ’s method of telling us that something is wrong. Pain is important;
without it abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies.
Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone
too far in its design. Aside from its value in diagnosis, long-lasting persistent pain serves no useful purpose.
Pain does not begin until coded message travels to the brain where it is decoded, analysed, and then reacted
to. The pain message travels from the injured area along the small nerves leading to the spinal cord. Here the
message is switched to different nerves that travel up the spinal cord to the brain. The pain message is then
interpreted, referred back and the pain is felt.
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug-free method of controlling pain. TENS uses
tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure
any physiological problem; it only helps control the pain. TENS does not work for everyone; however, in most
patients it is effective in reducing or eliminating the pain, allowing for a return to normal activity.
HOW TENS WORKS
There is nothing “magic” about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to be
used to relieve pain. The TENS unit sends comfortable impulses through the skin that stimulate the nerve
(or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain
sensation the patient feels. Pain relief varies by individual patient, mode selected for therapy, and the type of
pain. In many patients, the reduction or elimination of pain lasts longer than the actual period of stimulation
(sometimes as much as three to four times longer). In others, pain is only modied while stimulation actually
occurs. You may discuss this with your physician or therapist.

7
1. Panel Cover: A lid covers the controls for selecting mode and adjusting settings. Your medical professional
may wish to set these controls for you and request that you leave the cover in place.
2. Power On/Off Switch and Intensity Controls: If both controls are in the off position, the device is switched
off. By turning the controls clockwise, the appropriate channel is switched on and the indicator of power
(CH1 or CH2) will reveal on the LCD.
The current strength of the impulses transmitted to the electrodes increases further when the control is
turned clockwise.
To reduce the current strength or switch the device off, turn the control counterclockwise to the required
setting or off-position, respectively. The controls are protected by a cap to avoid an unintentional change of
intensity.
3. Mode Control
There are 5 TENS modes(B, N, M, SD1, SD2) and 2 EMS modes (S, A) available. The mode can be selected by
pressing the “Mode” control. When a TENS mode is selected, the LCD shows “TENS” on the top. When EMS
mode is selected, the LCD shows “EMS” on the top.
ADJUSTING THE CONTROLS IN TENS MODE

8
4. Set Control
By pressing the “Set” control, you may enter the setting you intend to make adjustments. You may start to
set the value by pressing the “Increment” and “Decrement” controls when the value is ashing.
5. Increment Control
This button controls the increase of settings. When pressing this button, the parameter will increase.
6. Decrement Control
This button controls the decrease of parameter. When pressing this button, the parameters will decrease.
7. Timer
The unit has a timer of 1-60 minutes and is Continuous. It can be adjusted by pressing the “Set” and
“Increment” or “Decrement” controls. The treatment time will countdown automatically in one-minute
increments. Its output will be shut off when time is up.
8. Low Battery Indicator
A low battery sign will show up on the liquid crystal display when it needs to be replaced as soon as
possible. The unit may continue to operate for a few more hours depending on the setting intensity level.
9. Steps to Set a TENS Program
The settings can be adjusted according to the following steps.
a. Turn on the Intensity
After the electrodes are placed rmly on the skin and the lead wires are plugged into the socket of the
device, turn the on/off control clockwise. The menu will reveal on LCD. Notice the indication of power and
function on the LCD.
b. Select a Mode
Select a mode by pressing the “Mode” control. The mode you selected will show up on the top of the liquid
crystal display. There are 5 modes of your option including – B (Burst), M(Normal), M (Modulation), SD1,
and SD2. When a TENS mode is selected, it shows “TENS” on the top of the liquid crystal display.
After a mode is selected, always press “Set” to enter the next setting, and press “Increment or “Decrement”
to adjust its value.
ADJUSTING THE CONTROLS IN TENS MODE

9
ADJUSTING THE CONTROLS IN TENS MODE
c. Set Pulse Width
Pulse Width is adjustable from 50 us to 300 us. Press the “SET” control to enter this menu, then press
“Increment” or “Decrement” to adjust the setting. If no instructions regarding the pulse width are given in
therapy, set the control to the suggested 70-120 us setting.
d. Set Pulse Rate
The pulse rate is adjustable from 2Hz to 150Hz. Press the “SET” control to enter this menu, then press
“Increment” or “Decrement” to adjust the setting. Unless otherwise instructed, turn the pulse rate control to
the 70-120 Hz range.
e. Set Timer
The treatment time is adjustable from 1 to 60 minutes or C (Continuous). Press the “SET” control to enter
this menu, then press “Increment” or “Decrement” to adjust the setting. Press the “Increment” control when
the timer shows 60 minutes, it will be switched to continuous stimulation.

10
INTRODUCTION TO EMS
There is nothing “magic” about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to be
used to relieve pain. The TENS unit sends comfortable impulses through the skin that stimulate the nerve
(or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain
sensation the patient feels. Pain relief varies by individual patient, mode selected for therapy, and the type of
pain. In many patients, the reduction or elimination of pain lasts longer than the actual period of stimulation
(sometimes as much as three to four times longer). In others, pain is only modied while stimulation actually
occurs. You may discuss this with your physician or therapist.
EXPLANATION OF EMS
Electrical Muscle Stimulation is an internationally accepted and proven way of treating muscular injuries.
It works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise
passively.
It is a product derived from the square waveform, originally invented by John Faraday in 1831. Through the
square wave pattern it is able to work directly on muscle motor neurons. The EMS has low frequency and this
in conjunction with the square wave pattern allows direct work on muscle groupings. This is being widely used
in hospitals and sports clinics for the treatment of muscular injuries and for the re-education of paralyzed
muscles, to prevent atrophy in affected muscles and improving muscle tone and blood circulation.
HOW EMS WORKS
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion
The EMS units send comfortable impulses through the skin that stimulate the nerves in the treatment area.
When the muscle receives this signal it contracts as if the brain has sent the signal itself. As the signal
strength increases, the muscle exes as in physical exercise. Then when the pulse ceases, the muscle relaxes
and the cycle starts over again,
(Stimulation, Contraction and Relaxation.) Powered muscle stimulators should only be used under medical
supervision for adjunctive therapy for the treatment of medical diseases and conditions.

11
ADJUSTING THE CONTROLS IN EMS MODE
10. Steps to Set a EMS Program
The settings can be adjusted according to the following steps.
f. Turn on the Intensity
After the electrodes are placed rmly on skin and the lead wires are plugged in the socket of device, turn the
on/off control clockwise. The menu will reveal on LCD. Notice the indication of power and function on the
LCD.
g. Select Mode
There are two EMS modes of option, S(Synchronous) or A (Alternate). Select a mode by pressing the “Mode”
control. When an EMS mode is selected, the LCD shows “EMS” on the top. After a mode is selected, press
“SET” control to enter the next setting. You may adjust the setting only when it is ashing. Then press the
“Increment” or “Decrement” control to change the settings.
h. Set Ramp Time
The ramp time controls the time of output current that increase from 0 to the setting level, and from the
setting value to 0. When the ramp time is set, each contraction may be ramped up and down in order that
the signals come on and come off gradually and smoothly. The ramp time is adjustable from 1 to 8 seconds.
i. Set On Time
The On-Time controls the time of stimulation. By pressing the “Set” control, the contraction time can be
adjusted. Both channels’ stimulation is cycled on and off by the contraction and relaxation settings. The
range is adjustable from 2 seconds to 90 seconds.
As the “ON” time includes the ramp up and ramp down time, the setting of it should be no less than two
times the “Ramp” time. (ON TIME ≥Ramp up + Ramp down)

12
j. Set Off Time
The Off Time controls the time of relaxation. By pressing the “SET” control, the relaxation time can be
adjusted. Both channels’ stimulation is cycled on and off by the contraction and relaxation settings. The
range is adjustable from 0 seconds to 90 seconds.
In Alternate mode, the OFF Time should be equal to or more than the ON Time. (OFF TIME≥ON TIME)
k. Set Pulse Width
Pulse Width is adjustable from 50 us to 300 us. Press “SET” control to enter this menu, then press
“Increment” or “Decrement” to adjust the setting. If no instructions regarding the pulse width are given in
therapy, set the control to the suggested 70-120 us setting.
m. Set Timer
The treatment time is adjustable from 1 to 60 minutes or C (Continuous). Press “SET” control to enter this
menu, then press “Increment” or “Decrement” to adjust the setting. Press the “Increment” control when the
timer shows 60 minutes, and it will be switched to continuous stimulation.
ADJUSTING THE CONTROLS IN EMS MODE

13
ADJUSTING THE CONTROLS IN EMS MODE
11. Compliance Meter
This unit can store 60 sets of operation records. A total treatment time of up to 999 hours can be stored.
Check & Delete Individual Records
Press the “Mode” control and turn on the power simultaneously. The LCD will show the number of records
and operation time. Press the “Increment” and “Decrement buttons to check each record.To delete a
record, press “SET” control for 3 seconds.
Check & Delete Accumulative Record
At the individual records menu, press the “Mode” control to switch to the accumulative record menu. Press
the “SET” control rst, then press the “Mode” control simultaneously for 3 seconds and all of the records
will be deleted followed by a beeper sound.

14
TENS CAUTIONS
IMPORTANT SAFETY INFORMATION
1. Read instruction manual before operation. Be sure to comply with all “CAUTIONS” and “WARNINGS” in the
manual. Failure to follow instructions can cause harm to user or device.
2. Do not use this device for undiagnosed pain syndromes until consulting a physician.
3. Patients with an implanted electronic device, such as a cardiac pacemaker, implanted debrillator, or any
other metallic or electronic device should not undergo TENS treatment without rst consulting a doctor.
4. Patients with heart disease, epilepsy, cancer or any other health condition should not undergo TENS
treatment without rst consulting a physician.
5. Stimulation delivered by this device may be sufcient to cause electrocution. Electrical current of this
magnitude must not ow through the thorax or across the chest because it may cause a cardiac arrhythmia.
6. Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may
occur. Stimulation over the carotid sinus (neck region) may close the airways, make breathing difcult, and
may have adverse effects on the heart rhythm or blood pressure.
7. Do not place electrodes on your head or at any sites that may cause the electrical current to ow
transcerebrally (through the head).
8. This device should not be used while driving, operating machinery, close to water, or during any activity in
which involuntary muscle contractions may put the user at undue risk of injury.
9. Turn the TENS off before applying or removing electrodes.
10. Isolated cases of skin irritation may occur at the site of electrode placement following long term
application. If this occurs, discontinue use and consult your physician.
11. If TENS therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is re-
evaluated by a physician
12. Keep this device out of the reach of children.
13. The device has no AP/APG protection.
Do not use it in the presence of explosive atmosphere and ammable mixture.

15
EMS CAUTIONS
1. Safety of powered muscle stimulators for use during pregnancy has not been established.
2. Caution should be used for patients with suspected or diagnosed heart problems.
3. Caution should be used for patients with suspected or diagnosed epilepsy.
4. Caution should be used in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the healing process;
c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation.
5. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical
conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or
alternate electrode placement.
6. Electrode placement and stimulation settings should be based on the guidance of the prescribing
practitioner.
7. Powered muscle stimulators should be kept out of the reach of children.
8. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the
manufacturer.
9 Driving, operating machinery, or during any activity in which involuntary muscle contractions may put the
user at undue risk of injury.
CONTRAINDICATIONS
Electrical stimulators should not be used on patients with cardiac demand pacemakers.
ADVERSE REACTIONS
Skin irritation and burns beneath the electrodes have been reported with the use of electrical stimulators. If
irritation occurs, discontinue use and consult your physician.

16
WARNINGS
1. The long-term effects of chronic electrical stimulation are unknown.
2. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known
sensitivity to the carotid sinus reex.
3. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal
muscles may occur and the contractions may be strong enough to close the airway or cause difculty in
breathing.
4. Stimulation should not be applied transthoracically in that the introduction of electrical current into the
heart may cause cardiac arrhythmias.
5. Stimulation should not be applied transcerebrally.
6. Stimulation should not be applied over swollen, infected, or inamed areas or skin eruptions, e.g., phlebitis,
thrombophlebitis, varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to, cancerous lesions.
MAINTENANCE, TRANSPORTATION AND
STORAGE OF THE DEVICE
1. Non-ammable cleaning solution is suitable for cleaning the device. Note: Do not smoke or work with open
lights (for example, candles, etc.) when working with ammable liquids.
2. Stains and spots can be removed with a cleaning agent.
3. Do not submerge the device in liquids or expose it to large amounts of water.
4. Return the device to the carrying box to ensure that the unit is well-protected before transportation.
5. If the device is not to be used for a long period of time, remove the batteries from the battery compartment
(acid may leak from used batteries and damage the device). Put the device and accessories in carrying box
and keep it in cool dry place.
6. The packed TENS/ EMS device should be stored and transported under the temperature range of -20°C ~ +
60°C, relative humidity 20%~ 95%, atmosphere pressure 500 hPa~ 1060 hPa.

17
SAFETY-TECHNICAL CONTROLS
For safety reasons, review the following checklist before using your Med-Fit 3 Plus TENS/EMS
1. Check the device for external damage.
- deformation of the housing.
- damaged or defective output sockets.
2. Check the device for defective operating elements.
- legibility of inscriptions and labels.
3. Check the usability of accessories.
- patient cable undamaged.
- electrodes undamaged.
- Battery is not corroded
MALFUNCTIONS
Should any malfunctions occur while using the Med-Fit 3 Plus TENS/EMS, check
- whether the parameters are set to the appropriate form of therapy. Adjust the control correctly.
- whether the cable is correctly connected to the device. The cables should be inserted completely into the
sockets.
- whether the LCD reveals the menu. If necessary, insert a new battery.
- for possible damage to the cable. Change the cable if any damage is detected.
CONFORMITY TO SAFETY STANDARDS
The Med-Fit 3 Plus TENS/EMS devices are in compliance with the following standards:
EN60601-1:2006/A1:2013 Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
EN60601-1-2:2015 Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance –Collateral
Standard: Electromagnetic disturbances - Requirements and tests

18
Degree of Electrical Protection BF
Do not insert the plug into AC power supply socket
Timer
Increment
Decrement
Consult instructions for use
Manufacturer
Serial number
Degrees of protection provided by enclosures (IP Code)
Low battery
Notied Body Number of DNV GL Presafe AS
Indicates the Authorized
Representative in the European Community.
GRAPHIC SYMBOLS
II. LABEL
The label attached to the back of device contains important information abou t this device -
model name,serial number(started with manufacturing year and week of the device), supply
voltage, name of the manufacturer, CE number and classication. Please do not remove.

19
Contenido
QUÉ HAY EN LA CAJA ................................................................................................. 20
GUÍA PASO A PASO ..................................................................................................... 21
DESCRIPCIÓN GENERAL ............................................................................................. 23
INTRODUCCIÓN A TENS .............................................................................................. 23
AJUSTE DE LOS CONTROLES EN MODO TENS .............................................................. 24
INTRODUCCIÓN AL SGA .............................................................................................. 27
AJUSTE DE LOS CONTROLES EN MODO EMS ............................................................... 28
TENS PRECAUCIONES ................................................................................................. 31
PRECAUCIONES EMS .................................................................................................. 32
ADVERTENCIAS Y PRECAUCIONES .............................................................................. 33
CONTROLES TÉCNICOS DE SEGURIDAD ....................................................................... 34
MAL FUNCIONAMIENTO ............................................................................................. 34
CONFORMIDAD CON LAS NORMAS DE SEGURIDAD ...................................................... 34
SYMBOLES GRAPHIQUES............................................................................................. 35
medfit
Prueba de parche cutáneo
Se recomienda realizar una prueba de parche antes de aplicar su primer tratamiento. Para ello, extraiga un
electrodo del embalaje y colóquelo en una parte de su cuerpo que sea visible y fácil de inspeccionar.
Después de 30 minutos, retire el electrodo e inspeccione el área en busca de enrojecimiento o irritación.
Si no se nota ningún cambio, continúe con su primer tratamiento TENS siguiendo la Guía del usuario y las
Instrucciones proporcionadas. Si se ha notado irritación en la piel, recomendamos el uso de electrodos de gel
sensibles.

20
12
4
3
1
5
1. Unidad DECENAS
2. Manual de usuario
3. 2 baterías de 9v
4. 16 electrodos autoadhesivos de 5x5.
5. 2 derivaciones de pacientes
Estuche
¿Qué hay en la caja?