Roundwhale R-C1-K01 User manual

INSTRUCTION MANUAL
FOR
3-in-1 Combo Electrotherapy Device
Operation Manual for Model #: R-C1-K01

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-C1-K01 Rev.V1.0 © 2020, printed in Apr. 10, 2020.
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, ISO 14971

TABLE OF CONTENS
1. FOREWORD 4
2. SAFETY INFORMATION 7
3. GETTING TO KNOW YOUR DEVICE 12
4. SPECIFICATION 14
5. OPERATING INSTRUCTION 15
6. INSTRUCTIONS FOR USE 21
7. CLEANING AND MAINTENANCE 29
8. TROUBLESHOOTING 30
9. STORAGE 31
10. DISPOSAL 32
11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES 32
12. NORMALIZED SYMBOLS 36
13. WARRANTY 37

4
1. FOREWORD
1.1 Introduction
The device R-C1-K01 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 28
programs (15 TENS programs, 8 EMS programs and 5
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’s natural pulses, the mech-
anism of electrical stimulation equipment is to create
electric impulses that are transcutaneous transmitted to
the dual channel can be adjusted independently and can
be applied individually to one body part. This dual channel
device can be used with four pieces of electrodes, which
allows you to stimulate one muscle groups simultaneously
with a wide selection of standard programs. The electrical
transmission of stimulation in nerves as well as muscle tis-
sues in the body parts.
nerves or muscle fibers through electrode. The intensity of
pulse is firstly transmitted to the tissue, then it affects the

5
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
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.
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
-
-
-
-
spinal cord. There the message is transmitted to different

6
The massage function is non-medical function. The Massage
stimulation program provides relaxing muscle vibration to
loosen tight muscles.
1.2.4 WHAT IS MASSAGE ?
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.

7
2. SAFETY INFORMATION
2.1 Intended use
TENS mode
To be used for temporary relief of pain associated with
sore and aching muscles in the shoulder, waist, back,
neck, upper extremities (arm) and lower extremities (leg)
due to strain from exercise or normal household work
activities.
EMS mode
To be used to stimulate healthy muscles in order to
improve and facilitate muscle performance.
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
TENS and EMS can be used in the home, using the object
(patient) must be 18 years or older of adults.
use could cause electric shock, burns, electrical inter-
ference, or death.
2) The device should not be used when cancerous lesions
or other lesions are present in the treatment area.
1) Do not use this device if you are using a cardi-
implanted metallic or electronic devices. Such
2.2.1 Contraindication

8
3) Stimulation should not be applied over swollen, in-
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
pain, consult with your physician before use.
2) If your pain is not subdued, becomes more than mild,
and consult with your physician.
3) Do not apply stimulation over your neck because this
could cause severe muscle spasms resulting in closure
heart rhythm or blood pressure.
4) Do not apply stimulation across your chest because the
introduction of electrical current into the chest may
fected, inflamed ares or skin eruption (e.g. phlebitis,
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
of your airway, difficulty in breathing, or adverse effects on

9
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.
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.
or microwave therapy equipment, since this may affect
are in contact with each other.
17) Never use it on the areas of the skin which lack normal
sensation
18) Keep electrodes separate during treatment. It could re-
sult in improper stimulation or skin burns if electrodes

10
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) TENS
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-
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.
tion by a practitioner qualified in the management of
is not effective for pain of central origin including
9) Caution if you have a tendency to bleed internally, e.g.
following an injury of fracture.
10) Consult with your physician prior to using the device
after a recent surgical procedure, because stimulation
may disrupt the healing process.

11
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.
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) On very rare occasions, first-time users of EMS report
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.

12
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
4USB cable 1pc
5 User manual 1pc
3.2 LCD display
1
2
3
4
5
6
No.
Function description
1 Model of human body
2Treatment mode
3Program NO.
4 Treatment time
5 Intensity for Channel B
6 Intensity for Channel A

13
3.3 Device illustration
8
1
2
3
4
11
5
6
7
910
No. Description
1 Device display
2
[M] button: Select treatment mode / Pause and
resume the treatment
3
[+]/[-] button: Button to increase or decrease the
intensity level of CH1
4
[T] button: Button to increase the treatment
time
5 [S] button: Select treatment body part
6
[+]/[-] button: Button to increase or decrease the
intensity level of CH2
7 [P] button: Select treatment program
8
[ON/OFF] button: Button to power on and off / Stop
the treatment
9 Blet Clip
10
USB charging port and Battery charging indicator
light
11 Sockets for electrode pad wires

14
4. SPECIFICATION
4.1Technical information
Device name Combo Electrotherapy Device
Model/type R-C1-K01
Power sources 3.7 V Li-ion battery
Output Channel Dual channel
Waveform Bi-phase square-wave pulse
Output current 0-60mA (at 1000ohm load)
Output intensity 0 to 60 levels, adjustable
Treatment mode: TENS , EMS and MASSAGE mode
Operating conditi-
on
5℃ to 40℃ with a relative humidity of 15%-
93%, atmospheric pressure from 700 hPa
to 1060 hPa
Storage condition
-10℃ to 55℃ with a relative humidity of
10%-95%, atmospheric pressure from 700
hPa to 1060 hPa
Dimension 120.5x69.5x27 mm (L x W x T)
Weight about 140g
Automatic shutoff 1 minutes
Power supply Input: 100-240V AC, 50/60Hz,0.2A; Output: 5V
DC, 300mA
Number of programs
TENS： 15 programs
EMS： 8 programs
MASSAGE： 5 programs
P.W. (Pulse Width)
P.R. (Pulse Rate)
Treatment time 10-90 minutes (adjustable)
2-120Hz (Hz=vibration per second)
50-300us
Classification BF type applied part, internal power equip-
ment, IP22
Electrode detection
function
The electric current level will be reset to 0 mA,
when the amplitude level is 10 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
parameters

15
5. OPERATING INSTRUCTION
5.1 Charging the Battery:
Proceed as follows to recharge the battery:
• This device cannot be used while charging.
• Make sure that the device is no longer connected to the
patient (the output cables and electrodes must be dis-
connected).
• Connect the USB cable to the charging port on the device.
• Connect the USB cable to the charger.
• When the device is charging, the indicator light will be yel-
low.
• It could take up to 2 hours to reach a full charge.
• When charging is completed, the indicator light will be
green.
The life of a rechargeable battery depends on the number
of recharging/rundown cycles it undergoes and how these
cycles are performed.
The following suggestions will help prolong the life of the
battery:
•Whenever the device is not used frequently, charge the
battery once a month.
• For longer battery life, discharge the battery as much as
possible.
5.2 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.

16
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.
5.3 Connect electrodes wires to device
Before proceeding to this step, be sure the device is com-
pletely 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 de-
vice has two output receptacles controlled by Channel 1
and Channel 2 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 different
Caution
Do not insert the plug of the electrode
wires into any AC power supply socket.
5.4 Electrode
5.4.1 Electrode options
The electrodes are disposable and should be routinely re-
placed when they start to lose their adhesiveness. If you are
unsure of your electrode adhesive properties, please order
new replacement electrodes. Replacement electrodes
should be re-ordered under the advice of your physician or
the device manufacturer to ensure proper quality. Follow
application procedures outlined on electrode packings
areas at the same time.
electrode wire

17
when using the new replacement electrodes to maintain
optimal stimulation and to prevent skin irritation.
5.4.2 Place electrodes on skin
Place the electrode on the body part in need of treatm-
ent, according to the instruction of this user manual. Ple-
ase 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.
or the appropriate channel first in order to avoid un-
wanted irritation.
5. It is recommended that, at minimum, 1.97”x 1.97”
self-adhesive square electrodes are used at the treat-
ment area.
6. Never remove the self-adhesive electrodes from the skin
while the device is still on.
5.4.3 Electrode placement
R-C1-K01 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.
Conducting exercise, treatment and adjustment based
on your own feeling.
4. To remoce or move the electrodes, switch off the device

18
toms as below:
Position of electrode placement under TENS programs
Neck
Shoulder
Arm
Hand
Back 1
1
2
2
Hip
Different programs with corresponding applicable symptoms

19
Leg
1２
Foot
Joint
(Knee)
Joint
(Elbow)
Joint
(Ankle)
Joint
(Wrist)
Neck 1
2
1
2
Position of electrode placement under EMS programs

20
Shoulder
1
1
2
2
Arm
Hand
Back
Abdomen 1
2
1 2
Hip
Leg
Foot