Shenzhen Roundwhale Technology R-C4A User manual

INSTRUCTION MANUAL
FOR
Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co., Ltd.
This manual is valid for the R-C4A Stimulator
Model: R-C4A
Be sure to read this instruction manual before operating and
keep it where safe.
This user manual is published by Shenzhen Roundwhale
Technology Co., LTD.
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Shenzhen Roundwhale Technology Co., Ltd. does not
guarantee its contents and reserves the right to improve
and amend it at any time without prior notice. However,
Amendments will be published in a new edition of this
manual.
All Rights Reserved.
R-C4A Rev.V1.1© 2019, printed in May. 6, 2019.
Declaration of conformity:
Shenzhen Roundwhale Technology Co., Ltd. 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 4
2. SAFETY INFORMATION 6
3. GETTING TO KNOW YOUR DEVICE 11
4. SPECIFICATION 14
5. OPERATING INSTRUCTION 15
6. INSTRUCTIONS FOR USE 21
7. CLEANING AND MAINTENANCE 30
8. TROUBLESHOOTING 32
9. STORAGE 33
10. DISPOSAL 34
11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES 34
12. NORMALIZED SYMBOLS 40
13. WARRANTY 41
TABLE OF CONTENS
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1. FOREWORD
Introduction
The device R-C4A is a dual channel output TENS, EMS and
MASSAGE stimulator. Before using, please read all the in-
structions in this user manual carefully and keep it safe for
future use.
The COMBO stimulator belongs to the group of electrical
stimulation systems. It has three basic functions‒ TENS
(Transcutaneous Electrical Nerve Stimulation), EMS (Elec-
tronic Muscle Stimulation) and MASSAGE.
Function of the COMBO 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 mecha-
nism of electrical stimulation equipment is to create elec-
tric impulses that are transcutaneous transmitted to nerves
or muscle fibers through the electrode. The intensity of
the dual channel can be adjusted independently and app-
lied 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 wi-
-
of stimulation in nerves as well as muscle tissues in the
body parts.
s
de
st
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1.2 Medical background
1.2.1 ABOUT PAIN
Pain is an important signal in the human body warning sys-
tem. 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.
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 ef-
fective 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-in-
hibiting mechanisms of the nervous system. Electrical im-
pulses 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-frequen-
cy TENS currents facilitate the release of endorphins, the
body’s natural painkillers.
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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 group-
ings.
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.
EMS mode
The EMS stimulation program stimulates healthy muscles
in order to improve and facilitate muscle performance.
Massage mode
The Massage stimulation program provides relaxing muscle
vibration to loosen tight muscles.
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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.
SAFETY SYMBOLS USED IN THIS MANUAL
2.2.1 Contraindication
1) Do not use this device if you are using a cardi-
ac pacemaker, implanted de󽗉brillator, or oth-
er 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, in-
fected, 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 tran-
scerebrally (through the head).
5) This device should not be used in
overly enervated areas.
6) 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 WARNING
1) If you have had medical or physical treatment for your
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pain, consult with your physician before use.
2) If your pain is not subdued, whice becomes more th-
device and consult with your physician.
3) Do not apply stimulation over your neck because this
could cause severe muscle spasms resulting in closure
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.
5) Do not apply stimulation over, or in proximity to, can-
cerous 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 electri-
cal 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 ma-
chinery, or during any activity when electrical stimula-
tion can put you at risk of injury.
10) Apply stimulation only to normal, intact, clean, healthy
skin.
11) The long-term effects of electrical stimulation are un-
known. Electrical stimulation device cannot replace
drugs.
12) Stimulation should not take place while the user is con-
nected to high-frequency surgical equipment, which
may cause burn injuries on the skin under the elec-
trodes, as well as problems with the stimulator.
an mild, or lasts for more than five days, stop using the
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13) Do not use the stimulator in the vicinity of shortwave
the output power of the stimulator.
14) Never use it near the cardiac area. Stimu-
lation 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 fibrillation 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 separated during treatment. It could re -
sult 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.
2.2.3 Precautions
1)
headache.
2) TENS is not a substitute for pain medications and other
pain management therapies.
3) TENS is a symptomatic treatment and, as such, sup-
presses the sensation of pain that would otherwise
serve as a protective mechanism.
4) Effectiveness is highly dependent upon patient selec-
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pain patients.
5) Since the effects of stimulation of the brain are un-
known, 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 conduc-
tive 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.
16) Do not use this device in the presence of other equip-
ment 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.
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18) Check the electrode connections before each use.
19) Electrical stimulators should be used only with the
electrodes recommended for use by the manufacturer.
2.2.4 Adverse Reactions
1) Possible skin irritation or electrode burn under the
electrodes may occur.
2)
feeling light-headed or faint. We recommend that you
use the product while seated until you become accus-
tomed 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 Combo Stimulator 1pc
2 Electrode pad （50mm×50mm ) 4pcs
3 Electrode wires 2pcs
4 USB cable 1pc
5 User manual 1pc
On very rare occasions, first-time users of EMS report
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3.2 LCD display
1
2
3
4
5
6
7
8
9
10
11
12
13
14 15 16
No. Function description No. Function description
1 Treatment mode 9 Program NO. or Treatment time
2 Key locking symbol 10 Massage type
3 Treatment body part 11 SET symbol.
4 Model of human body 12 Pulse rate and width symbol
5 Intensity for Channel A 13 Intensity for Channel B
6 Low battery symbol 14 Symbol of Channel A
7 Timer symbol 15
8 Program symbol 16 Symbol of Channel B
Indicator Flag of Channel selection
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3.3 Device illustration
1
2
3
7
6
5
4
8
9
No. Description
1 LCD display
2 Charger indicator:
When the device is charging, the indicator light will be yellow.
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
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 treat-
ment time status.
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.
10
At setting mode, press [P]button to select pulse rate, pulse width or
treatment time
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6 [B] button:
At standby mode, press the [B] button to select the treatment body part.
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
4. SPECIFICATION
4.1Technical information
Device name Combo Electrotherapy Device
Model/type R-C4A
Power sources 3.7 V Li-ion battery
Power supply Input: 100-240V AC, 50/60Hz,0.2A; Output: 5V
DC, 300mA
Output channel Dual channel
Waveform Bi-phase square-wave pulse
Output current Max. 120mA (at 500ohm load)
Output intensity 0 to 40 levels, adjustable
Treatment mode: TENS, EMS and MASSAGE mode
Operating condi-
tion
5° C to 40° C with a relative humidity of 15%-93%,
atmospheric pressure from 700 hPa to 1060 hPa
Storage condition -10° C to 55° C with a relative humidity of 10%-
95%, atmospheric pressure from 700 hPa to
1060 hPa
Dimension 109*54.5*23mm (L x W x T)
Weight About 82g
1 minute
BF type applied part, internal power equipment, IP22
At treating mode, press and hold [B] button turn on/off lock function.
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Electrode detec-
tion 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 50x50mm, square
Output precision ±20% error is allowed for all the output pa-
rameters
TENS mode
Number of programs 30 programs(10 treatment body parts)
P.W. (pulse width) 50-330μs
P.R. (Frequency) 2-120Hz (Hz=vibration per second)
Treatment time 5-90 minutes (adjustable)
EMS mode
Number of programs 27 programs (9 treatment body parts)
P.W. (pulse width) 150-300μs
P.R. (Frequency) 4-80Hz (Hz=vibration per second)
Treatment time 5-90 minutes (adjustable)
MASSAGE mode
Number of programs 3 programs
P.W. (Pulse width) 100-250μs
P.R. (Pulse Rate) 25-100Hz (Hz=vibration per second)
Treatment time 30 minutes
5. OPERATING INSTRUCTION
5.1 Connect electrode pads to electrode wires
Insert the electrode wires connector into electrode connec-
tor. Make sure they are properly connected to ensure the
good performance. Please refer to the picture.
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Caution
Always use the electrode pads which comply with the re-
quirements 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 re-
ceptacle on the top of the main device.
Ensure the electrode wires are inserted correctly. The de-
vice 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 ad-
at the same time.
Caution
Do not insert the plug of the electrode wires into any AC
power supply socket.
5.3 Electrode
5.3.1 Electrode options
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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 replace-
ment electrodes. Replacing electrodes should be re-or-
dered under the advice of your physician or the device
manufacturer to ensure proper quality. Follow application
procedures outlined on electrode packing when using the
new replacement electrodes to maintain optimal stimula-
tion and to prevent skin irritation.
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.
Caution
1. Always remove the electrodes from the skin with a mod-
erate pull in order to avoid injury in the event of highly
sensitive skin.
2. Before applying the self-adhesive electrodes, it is recom-
mended to wash and degrease the skin, and then dry it.
3. Do not turn on the device when the self-adhesive elec-
trodes 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 unwant-
ed irritation.
5. It is recommended that, at minimum, 1.97”x 1.97” self-ad-
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hesive square electrodes are used at the treatment area.
6. Never remove the self-adhesive electrodes from the skin
while the device is still on.
5.3.3 Electrode placement
R-C4A is a kind of OTC stimulator, suitable for home use.
You only have to use according to the user manual, place
the electrode on the position where you feel pain. Conduct
exercise, treatment and adjustment based on your own
feeling.
Position of electrode placement under TENS programs
Neck
Shoulder
Arm
Hand
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Back 1
1
2
2
Abdomen
Hip
Leg
1２
Foot
Joint
(knee)
Joint
(elbow)
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Joint
(ankle)
Joint
(wrist)
Position of electrode placement under EMS programs
Neck 1
2
1
2
Shoulder
1
1
2
2
Arm
Hand
Back
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