Mediblink M600 User manual

EN Mediblink Electro Therapy Device M600
INSTRUCTIONS FOR USE
Please read the instructions for use carefully before using
the product
SLO Mediblink Elektroterapevtska naprava M600
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete
navodila za uporabo
HR Mediblink Uređaj za elektroterapiju M600
UPUTE ZA UPOTREBU
Pažljivo pročitajte upute prije upotrebe uređaja

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EN
TABLE OF CONTENTS
1. Foreword 6
2. Safety Information 8
3. Getting to Know your Device 12
4. Specication 16
5. Operating Instruction 19
6. Instructions for Use 24
7. Cleaning and Maintenance 33
8. Troubleshooting 34
9. Storage 35
10. Disposal 35
11. Electromagnetic Compatibility (EMC) tables 36
12. Normalized Symbols 40
13. Warranty 41

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SLO
1. Predgovor 44
2. Varnostne informacije 46
3. Spoznavanje naprave 50
4. Specikacija 54
5. Navodila za upravljanje 57
6. Navodila za uporabo 62
7. Čiščenje in vzdrževanje 71
8. Odpravljanje napak 72
9. Shranjevanje 73
10. Odstranjevanje 73
11. Preglednice elektromagnetne združljivosti (EMC) 74
12. Normalizirani simboli 78
13. Garancija 79
KAZALO VSEBINE

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HR
SADRŽAJ
1. Predgovor 82
2. Podatci o sigurnosti 84
3. Upoznavanje s uređajem 88
4. Specikacija 92
5. Upute za rad 95
6. Upute za upotrebu 100
7. Čišćenje i održavanje 109
8. Rješavanje problema 110
9. Čuvanje 111
10. Odlaganje 111
11. Tablice elektromagnetske (EMC) kompatibilnosti 112
12. Normalizirani simboli 116
13. Jamstvo 117

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Manufacturer declares that the device complies with following
normative documents: IEC60601-1, IEC60601-1-2, IEC60601-
1-11, IEC60601-2-10, IEC62304, ISO10993-5, ISO10993-10,
ISO10993-1, ISO14971

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1. Foreword
1.1 Introduction of M600
The device M600 is a dual channel output TENS, EMS and
MASSAGE stimulator. Before using, please read all the
instructions in this user manual carefully and keep it safe for
future use.
The M600 stimulator belongs to the group of electrical
stimulation systems. It has three basic functions ‒ TENS
(Transcutaneous Electrical Nerve Stimulation), EMS
(Electronic Muscle Stimulation) and MASSAGE.
Function of the M600 stimulator: The device has 60 programs
(30 TENS programs, 27 EMS programs and 3 MASSAGE
programs) and applies electric currents in the low-frequency
range for therapy. Each program controls the generated
electric impulses, their intensity, frequency and pulse width.
Based on simulating the body’natural pulses, the mechanism
of electrical stimulation equipment is to create electric impulses
that are transcutaneous transmitted to nerves or muscle bers
through the electrode. The intensity of the dual channel can be
adjusted independently and applied individually to one body
part. This dual channel device can be used with four pieces of
electrodes, which allow you to stimulate one muscle groups
simultaneously with a wide selection of standard programs.
The electrical pulse is rstly transmitted to the tissue, then it
a󰀨ects the transmission of stimulation in nerves as well as
muscle tissues in the body parts.
1.2 Medical background
1.2.1 About pain
Pain is an important signal in the human body warning system.
It reminds us that something is wrong, without which, 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.

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Aside from its function in diagnosis, long-lasting persistent pain
serves useless purpose.
Pain does not occur until encoded message travels to the brain
where it is decoded, analyzed, and reacted to, from the injured
area along the small nerves leading to the spinal cord. There
the message is transmitted to di󰀨erent nerves that travel up the
spinal cord to the brain. Then the pain message is interpreted,
referred to and pain is felt.
1.2.2 What is TENS?
TENS (Transcutaneous Electrical Nerve Stimulation) is
e󰀨ective in relief of pain. It is daily used and clinically proven
by physiotherapists, caregivers and top athletes around the
world. High-frequency TENS currents activates the pain-
inhibiting mechanisms of the nervous system. Electrical
impulses from electrodes, placed on the skin over or near the
pain area, stimulate the nerves to block the pain signals to the
brain, causing the pain go unperceived. Low-frequency TENS
currents facilitate the release of endorphins, the body’s natural
painkillers.
1.2.3 What is 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 that causes
the muscle to exercise passively. It is a product deriving 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 System has low
frequency and this in conjunction with the square wave pattern
allows direct work on muscle groupings.
1.2.4 What is MASSAGE?
The massage function is non-medical function. The Massage
stimulation program provides relaxing muscle vibration to
loosen tight muscles.

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2. Safety Information
2.1 Intended use
TENS mode
It is used for temporary relief of pain associated with sore and
aching muscles in the neck, shoulder, back, joint, hip, hand,
abdomen, foot, upper extremities (arm) and lower extremities
(leg) due to strain from exercise or normal household work
activities.
It is also intended for symptomatic relief and management
of chronic, intractable pain and relief of pain associated with
arthritis.
EMS mode
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 device can be used in the home or hospital, using the
object (patient) must be 18 years or older of adults.
2.2 Important Safety Precautions and
Warnings
It is important that you read all the warnings and precautions included in this manual because they are
intended to keep you safe, prevent risk of injury and avoid a
situation that could result in damage to the device.

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Safety symbols used in this manual
2.2.1 Contraindication
1) Do not use this device if you are using a cardiac
pacemaker, implanted debrillator, or other
implanted metallic or electronic devices. Such
use could cause electric shock, burns, electrical
interference, or death.
2) The device should not be used when cancerous lesions or
other lesions are present in the treatment area.
3) Stimulation should not be applied over swollen,
infected, inamed areas or skin eruptions (e.g. phlebitis,
thrombophlebitis, varicose veins, etc.).
4) Electrode placements must be
avoided in the carotid sinus area
(anterior neck) or transcerebrally
(through the head).
5) This device should not be used in
overly enervated areas.
6) Do not use in case of Inguinal hernia.
7) Do not use on scarred areas following a surgery for at least
10 months after the operation.
8) Do not use with serious arterial circulatory problems in the
lower limbs.
2.2.2 Warnings
1) If you have had medical or physical treatment for your pain,
consult with your physician before use.
2) If your pain is not subdued, whice becomes more than mild,
or lasts for more than ve days, stop using the device and
consult with your physician.
3) Do not apply stimulation over your neck because this could
cause severe muscle spasms resulting in closure of your
airway, di󰀩culty in breathing, or adverse e󰀨ects on heart
rhythm or blood pressure.
4) Do not apply stimulation across your chest because the
introduction of electrical current into the chest may cause
rhythm disturbances to your heart, which could be lethal.

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5) Do not apply stimulation over, or in proximity to, cancerous
lesions.
6) Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG
alarms), which may not operate properly when electrical
stimulation device is in use.
7) Do not apply stimulation when in bath or shower.
8) Do not apply stimulation while sleeping.
9) Do not apply stimulation while driving, operating
machinery, or during any activity when electrical
stimulation can put you at risk of injury.
10) Apply stimulation only to normal, intact, clean, healthy skin.
11) The long-term e󰀨ects of electrical stimulation are unknown.
Electrical stimulation device cannot replace drugs.
12) Stimulation should not take place while the user is
connected to high-frequency surgical equipment, which
may cause burn injuries on the skin under the electrodes,
as well as problems with the stimulator.
13) Do not use the stimulator in the vicinity of shortwave or
microwave therapy equipment, since this may a󰀨ect the
output power of the stimulator.
14) Never use it near the cardiac area. Stimulation
electrodes should never be placed anywhere
on the front of the thorax (marked by ribs and
breastbone), but above all not on the two large
pectoral muscles. There it can increase the risk of
ventricular brillation and lead to cardiac arrest.
15) Never use it on the eye, head and face area.
16) Never use it near the genitals.
17) Never use it on the areas of the skin which lack
normal sensation.
18) Keep electrodes separate during treatment. It could result
in improper stimulation or skin burns if electrodes are in
contact with each other.
19) Keep the stimulator out of reach of children.
20) Consult your doctor if you are in any doubt whatsoever.
21) Discontinue it and do not increase the intensity level if you
feel discomfort during use.

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2.2.3 Precautions
1) TENS is not e󰀨ective for pain of central origin including
headache.
2) TENS is not a substitute for pain medications and other
pain management therapies.
3) TENS is a symptomatic treatment and, as such,
suppresses the sensation of pain that would otherwise
serve as a protective mechanism.
4)
E󰀨ectiveness is highly dependent upon patient selection by
a practitioner qualied in the management of pain patients.
5) Since the e󰀨ects of stimulation of the brain are unknown,
stimulation should not be applied across your head, and
electrodes should not be placed on opposite sides of your
head.
6) The safety of electrical stimulation during pregnancy has
not been established.
7) You may experience skin irritation or hypersensitivity due
to the electrical stimulation or electrical conductive medium
(silica gel).
8) If you have suspected or diagnosed heart disease or
epilepsy, you should follow precautions recommended by
your physician.
9) Caution if you have a tendency to bleed internally, e.g.
following an injury of fracture.
10) Consult with your physician prior to use the device after a
recent surgical procedure, because stimulation may disrupt
the healing process.
11) Caution if stimulation is intended to be applied over the
menstruation or pregnant uterus.
12) For single patient use only.
13) This stimulator should not be used by patients who is
noncompliant and emotionally disturbed including whom
with dementia or low IQ.
14) The instruction of use is listed and should be obeyed; any
improper use may be dangerous.
15) Rare cases of skin irritation may occur at the site of the
electrode placement following long-term application.

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16) Do not use this device in the presence of other equipment
which sends electrical pulses to your body.
17) Do not use sharp objects such as a pencil or ballpoint tip to
operate the buttons on the control panel.
18) Check the electrode connections before each use.
2.2.4 Adverse Reactions
1) Possible skin irritation or electrode burn under the
electrodes may occur.
2) On very rare occasions, rst-time users of EMS report
feeling light-headed or faint. We recommend that you use
the product while seated until you become accustomed to
the sensation.
3) If the stimulation makes you uncomfortable, reduce the
stimulation intensity to a comfortable level and contact your
physician if problems continue.
3. Getting to Know Your Device
3.1 Accessories
No. Description QTY
1 The M600 Stimulator 1 pc
2 Electrode pad (50 mm × 50 mm) 4 pcs
3 Electrode wires 2 pcs
4 USB cable 1 pc
5 USB-C connector 1 pc
6 User manual 1 pc

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3.2 LCD display
1
5
2
6
7
8
9
10
3
4
No. Function description No. Function description
1 Treatment mode 6 Treatment body part
2 Massage type 7 Program NO. or
Treatment time
3 SET symbol 8 Pulse rate and width
4 Key locking symbol 9 Intensity for Channel B
5 Low battery symbol 10 Intensity for Channel A

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3.3 Device illustration
1
3
4
8
9
10
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6
No. Description
1 LCD display
2 Charger indicator:
When the device is charging, the indicator light will be
orange.
When charging is completed, the indicator light will be
green.
3 [ON/OFF/M] button: At power saving mode, press the
[ON/OFF/M] button to turn on the device;
At standby mode, press the [ON/OFF/M] button to
select the treatment mode; press and hold the [ON/
OFF/M] button to turn o󰀨 the device; At treating mode,
press the [ON/OFF/M] button to stop the treatment.
4 [P] button:
At standby mode, press the [P] button to select the
treatment program.
At standby mode, press and hold button to enter the
setting treatment time status.
At setting mode, press [P] button to select pulse rate,
pulse width or treatment time

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5 [+] button:
At standby or treating mode, press the [+] button to
increase the intensity of CH1 and CH2, CH1 or CH2;
At setting mode, press the [+] button to increase the
corresponding data for the pulse rate, pulse width and
treatment time.
6 [B] button:
At standby mode, press the [B] button to select the
treatment body part.
At treating mode, press and hold [B] button to turn on/
o󰀨 lock function.
7 [CH] button:
At standby mode or treating mode, press the [CH]
button to select the treatment channel.
8 [–] button:
At treating mode, press the [-] button to decrease the
intensity of CH1 and CH2 , CH1 or CH2.
At setting treatment time status, press the [–] button to
decrease the treatment time.
9 Output socket
10 USB socket

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4. Specication
4.1 Technical information
Device name Electro Therapy Device
REF M600
Model/type R-C4A
Power sources 3.7 V Li-ion battery
Power supply Input: 100–240 V AC, 50/60
Hz,0.2 A; Output: 5 V DC, 300 mA
Output channel Dual channel
Waveform Bi-phase square-wave pulse
Output current Max. 120 mA (at 500 ohm load)
Output intensity 0 to 40 levels, adjustable
Treatment mode: TENS, EMS and MASSAGE mode
Operating condition 5 °C to 40 °C with a relative humidity
of 15% to 93%, atmospheric
pressure from 700 hPa to 1060 hPa
Storage condition
–10 °C to 55 °C with a relative humidity
of 10% to 95%, atmospheric pressure
from 700 hPa to 1060 hPa
Dimension 109 x 54.5 x 23 mm (L x W x T)
Weight About 82 g
Automatic shuto󰀨 1 minute
Classication BF type applied part, internal power
equipment, IP22
Electrode detection
function
The electric current level will be
reset to 0 mA, when the amplitude
level is 1 or greater and an open
circuit at either channel is detected.
Size of electrodes pad 50 x 50 mm, square
Output precision ±20% error is allowed for all the
output parameters

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M600 Program Tables
Mode Body Part Program Pulse rate
(Hz)
Pulse width
(µS) Treatment time (Min) Remark
TENS
NECK
01 80–120 120–100 Default: 30, Adjustable: (5–90) Modulation
02 4 150–200 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 35, Adjustable:
(2–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Consistent
SHOULDER
01 80–100 100 Default: 30, Adjustable: (5–90) Modulation
02 2–60 260–160 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 100, Adjustable:
(2–100)
Default: 150,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Short Pulse
groups
ARM
01 2 250 Default: 30, Adjustable: (5–90) Consistent
02 100 150 Default: 30, Adjustable: (5–90) Short Pulse
groups
U1 Default: 100, Adjustable:
(2–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Consistent
HAND
01 100 100 Default: 30, Adjustable: (5–90) Consistent
02 2–10 200 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 60, Adjustable:
(2–100)
Default: 260,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Modulation
BACK
01 60/50/45/10/
50/35 200 Default: 30, Adjustable: (5–90) Modulation
02 6/8/10 250 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 55, Adjustable:
(2–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Modulation
ABDOMEN
01 80–120 120–100 Default: 30, Adjustable: (5–90) Modulation
02 120 55 Default: 30, Adjustable: (5–90) Consistent
U1 Default: 80, Adjustable:
(2–100)
Default: 100,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Consistent
HIP
01 100 150 Default: 30, Adjustable: (5–90) Short Pulse
groups
02 40/6/50 200 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 80, Adjustable:
(2–100)
Default: 180,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Consistent
LEG
01 40/6/50 250 Default: 30, Adjustable: (5–90) Modulation
02 80 150 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 6–10, Adjustable:
(2–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Modulation
FOOT
01 80–120 100–120 Default: 30, Adjustable: (5–90) Modulation
02 2–10 200 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 2–60, Adjustable:
(2–100)
Default:
260–160,
Adjustable:
(100–300)
Default: 30, Adjustable: (5–90) Modulation
JOINT
01 100 150 Default: 30, Adjustable: (5–90) Short Pulse
groups
02 120 100–120 Default: 30, Adjustable: (5–90) Modulation
U1 Default: 80, Adjustable:
(2–100)
Default: 180,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Consistent

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M600 Program Tables
Mode Body Part Program Pulse rate
(Hz)
Pulse width
(µS) Treatment time (Min) Remark
EMS
NECK
01 30 200 Default: 30, Adjustable: (5–90) Synchronous
02 40 200 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 50, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
SHOULDER
01 45 200 Default: 30, Adjustable: (5–90) Synchronous
02 55 200 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 80, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
ARM
01 50 150 Default: 30, Adjustable: (5–90) Synchronous
02 60 150 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 80, Adjustable:
(20–100)
Default: 150,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
HAND
01 4 200 Default: 30, Adjustable: (5–90) Synchronous
02 5 300 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 20, Adjustable:
(20–100)
Default: 150,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
BACK
01 60 200 Default: 30, Adjustable: (5–90) Synchronous
02 70 200 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 80, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
ABDOMEN
01 20 200 Default: 30, Adjustable: (5–90) Synchronous
02 50 200 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 60, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
HIP
01 30 150 Default: 30, Adjustable: (5–90) Synchronous
02 60 150 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 40, Adjustable:
(20–100)
Default: 150,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
LEG
01 20 200 Default: 30, Adjustable: (5–90) Synchronous
02 80 200 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 25, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
FOOT
01 4 200 Default: 30, Adjustable: (5–90) Synchronous
02 5 300 Default: 30, Adjustable: (5–90) Synchronous
U1 Default: 20, Adjustable:
(20–100)
Default: 200,
Adjustable:
(100–300) Default: 30, Adjustable: (5–90) Synchronous
MASSA-
GE
KNEAD 01 28–44 120~250 30 Modulation
RUB 01 25–79 120~250 30 Modulation
TAP 01 49–97 100~240 30 Modulation

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5. Operating Instruction
5.1 Connect electrode pads to electrode
wires
Insert the electrode wires connector into electrode connector.
Make sure they are properly connected to ensure the good
performance. Please refer to the picture.
Warning
Always use the electrode pads which comply with the
requirements of the IEC/EN60601-1, ISO10993-1/-5/-10 and
IEC/EN60601-1-2, as well as CE and FDA 510(K) regulation.
5.2 Connect electrode pads to electrode
wires
Before proceeding to this step, ensure that the device is
completely switched OFF. Hold the insulated portion of
the electrode wire connector, and insert the plug into the
receptacle on the top of the main device.
Ensure the electrode wires are inserted correctly. The device
has two output receptacles controlled by Channel A and
Channel B at the top of the unit. You may choose to use one
channel with one pair of electrode wires or both channels with
two pairs of electrode wires.
Using both channels gives the user the advantage of
stimulating two di󰀨erent areas at the same time.
Warning
Do not insert the plug of the electrode wires into any AC power
supply socket.

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5.3 Electrode
5.3.1 Electrode options
The electrodes should be routinely replaced when they start
to lose their adhesiveness. If you are unsure of your electrode
adhesive properties, please order new replacement electrodes.
Replacing electrodes should be re-ordered under the advice
of your physician or the device manufacturer to ensure proper
quality.
5.3.2 Place electrodes on skin
Place the electrode on the body part in need of treatment,
according to the instruction of this user manual. Please make
the skin clean before use and ensure the skin and electrode
connect well.
Warning
1. Always remove the electrodes from the skin with a moderate
pull in order to avoid injury in the event of highly sensitive skin.
2. Before applying the self-adhesive electrodes, it is
recommended to wash and degrease the skin, and then dry it.
3. Do not turn on the device when the self-adhesive electrodes
are not positioned on the body.
4. To remove or move the electrodes, switch o󰀨 the device
or the appropriate channel rst in order to avoid unwanted
irritation.
5. It is recommended that, at minimum, 50 x 50 mm self-
adhesive square electrodes are used at the treatment area.
6. Never remove the self-adhesive electrodes from the skin
while the device is still on.