Instruction Manual FOR 3-In-1 Combo Electrotherapy Device: Model: R-C1

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The manual provides instructions for using a 3-in-1 electrotherapy device that has TENS, EMS and massage functions. It details the various programs and settings that can be used for therapy and treatment.

The three main functions of the device are TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electronic Muscle Stimulation) and MASSAGE.

Section 2 of the manual provides important safety information about using the device properly and the precautions that need to be followed.

INSTRUCTION MANUAL

FOR
3-in-1 Combo Electrotherapy Device
Model: R-C1

Shenzhen Roundwhale Technology Co., Ltd.


This manual is valid for the R-C1 Stimulator

Be sure to read this instruction manual before operate and


keep it where safe.
This user manual is published by Shenzhen Roundwhale
Technology Co., LTD.
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 Rev.V1.1 © 2018, printed in Sep.11, 2018.

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 6
3. GETTING TO KNOW YOUR DEVICE 11
4. SPECIFICATION 13
5. OPERATING INSTRUCTION 14
6. INSTRUCTIONS FOR USE 20
7. Program 26
8. Cleaning and maintenance 28
9. Troubleshooting 30
10. Storage 31
11. Disposal 32
12. Electromagnetic compatibility (EMC) tables 32
13. Normalized symbols 37
14. WARRANTY 38
1. FOREWORD

Introduction
The device R-C1 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 36
programs (18 TENS programs, 15 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. The parameters for each program are list-
ed in clause 7.1.
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
nerves or muscle fibers through electrode . The intensity of
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
pulse is firstly transmitted to the tissue, then it affects the
transmission of stimulation in nerves as well as muscle tis-
sues in the body parts.

1.2 Medical background


1.2.1 ABOUT PAIN
Pain is an important signal in the human body warning sys-

4
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 different
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.

1.2.3 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

5
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 shoulder, low back, joint, hip,
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.

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 defibrillator, or other
implanted metallic or electronic devices. Such
6
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.
3) Stimulation should not be applied over swollen, in-
fected, inflamed 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
pain, consult with your physician before use.
2) If your pain is not subdued, becomes more than mild,
or lasts for more than five 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, difficulty in breathing, or adverse effects
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.

7
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.
13) Do not use the stimulator in the vicinity of shortwave
or microwave therapy equipment, since this may affect
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 separate during treatment. It could re-
sult in improper stimulation or skin burns if electrodes

8
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) TENS is not effective 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, sup-
presses the sensation of pain that would otherwise
serve as a protective mechanism.
4) Effectiveness is highly dependent upon patient selec-
tion by a practitioner qualified in the management of
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 using the device
after a recent surgical procedure, because stimulation
may disrupt the healing process.

9
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.

10
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 Ordinary batteries (1.5V, AAA) 4pcs
5 User manual 1pc

3.2 LCD display

No. Function description No. Function description


1 Treatment mode 10 Timer sign
2 Treatment body part 11 Standby mode: program num-
ber;
Working mode: treatment time
3 Low battery indicator 12 Key locking symbol
4 SET Sign 13 intensity of Channel2

5 PAUSE Sign 14 Unit of treatment intensity for


Channel 2
6 Symbol of Channel 1 15 AUTU Sign
7 Indicator of no load 16 Symbol of Channel 2
(Channel 1)
8 intensity of Channel1. 17 Indicator of no load (Channel 2)
9 Unit of treatment in-
tensity for Channel 1

11
3.3 Device illustration

No. Description
1 LCD display
2 [ON/OFF] button:
At power saving mode, press the [ON/OFF] button to turn on the de-
vice;
At standby mode, press the [ON/OFF] button to turn off the device;
At treating mode, press the [ON/OFF] button to stop the treatment.
At query mode, press the [ON/OFF] button to standby mode.
3 [M] button: At standby mode, press the [M] button to select the treat-
ment mode.
4 [B] button: At standby mode, press the [B] button to select the treat-
ment body part.
5 [P] button: At standby mode, press the [P] button to select the treat-
ment program.
6 [Q] button: At standby mode, press the [Q] button to query the treat-
ment records.
7 [+] button: At standby mode, press the [+] button to increase the CH1
and CH2 output intensity;

12
8 [-] button: At standby mode, press the [-] button to decrease the CH1
and CH2 output intensity;
At the key locking mode, press the [-] button to unlock the keys.
9 Battery cover
10 Battery compartment
11 Rating label
12 Output socket

4. SPECIFICATION

4.1Technical information
Device name 3-in-1 Combo Electrotherapy Device
Model/type R-C1
Power supply 6.0 V D.C., 4x AAA batteries
Output Channel Dual channel
Waveform Bi-phase square-wave pulse
Output voltage Max. 120Vpp (at 1000ohm load)
Output current Max. 60mA (at 1000ohm load)
Output intensity 0 to 60 levels, adjustable
Treatment mode: TENS , EMS and MASSAGE mode
Output characteristics Constant Current (CC)
Operating condition 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 120.5x69.5x27 mm (L x W x T)
Weight about 104g (without battery)
Automatic shutoff 3 minutes
Classification BF type applied part, internal power equip-
ment, IP22
Electrode detection The electric current level will be reset to 0
function mA, when the amplitude level is 1 or great-
er 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
13
TENS mode
Number of program 18 programs
P.W. (pulse width) 100-330μs
P.R. (Frequency) 2-125Hz (Hz=vibration per second)
Burst frequency 2Hz
Treatment time 30 minutes

EMS mode
Number of program 15 programs
P.W. (pulse width) 200-380μs
P.R. (Frequency) 1-110Hz (Hz=vibration per second)
Treatment time 28, 30 and 32 minutes

MASSAGE mode
Number of program 3 programs
P.W. (pulse width) 30-220μs
P.R. (Frequency) 25-290Hz (Hz=vibration per second)
Treatment time 30 minutes

5. OPERATING INSTRUCTION

5.1 Battery
5.1.1 Check/ replace batteries
Open the battery cover, insert
four batteries (type AAA) into the
battery compartment. Make sure
you are installing the batteries
properly. Be sure to place the
batteries according to the markings of positive end(+) and
negative end (-) in the battery compartment of device.

5.1.2 Disposal of battery


Spent batteries do not belong to the household
waste. Dispose of the battery following the current

14
regulations. As a consumer, you have legal obligation to
return spent battery to the Recycle Bin.

Caution
1. If a battery was swallowed accidentally, please seek med-
ical assistance immediately !
2. In case of battery leakage, please avoid contact with the
battery through skin, eyes and mucus membranes. Once
it occurs , please wash the contacted part with plenty of
clean water and contact your doctor immediately.
3. Battery cannot be dismantled, thrown into fire or
short-circuited.
4. Protect battery from excess heat; Take the battery out
of the product if they are spent or you don’t use it for
a long time. This can prevent device damage due to the
battery leakage.
5. Replace all of the batteries simultaneously!
6. Always replace the device with the same type battery.

5.2 Connect electrode pads to electrode wires


Insert the electrode wires connector into electrode con-
nector. Make sure they are properly con-
nected to ensure the good performance.
Please refer to the picture.

Caution
Always use the electrode pads which com-
ply 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.

5.3 Connect electrodes wires to device


Before proceeding to this step, be sure the
device is completely switched OFF.
Hold the insulated portion of the elec-
trode wire connector, and insert the plug

15
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 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
different areas at the same time.

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
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 treatment, according to the
instruction of this user manual. Please
make the skin clean before use and
ensure the skin and electrode connect
well.

16
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 off the device
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 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.

Different programs with corresponding applicable symp-


toms as below:
Position of electrode placement under TENS programs

Shoulder

17
Back

Arm
Palm

Top
of
hand

Leg

Joint

18
Joint

Hip

Position of electrode placement under EMS programs

Arm

Back

Leg

Shoulder

Hip

19
6. INSTRUCTIONS FOR USE

6.1 Turn on
When use it for the first time, open the battery cover and
load four new batteries (Please kindly review Section 5.1.1
for the operating steps and schematic diagram)
Press the [ON/OFF] button to turn the device on, the LCD
will be lit. And then it goes into the standby mode as below
picture shows.

6.2 Select treatment mode


Press the [M] button to select which treatment mode (TENS
–-MASS- EMS) you will use. The LCD displays as follows:

6.3 Select treatment body part


Based on your needs, press [B] button to select the current
treatment body part. Press each [B] button to switch body
part. The LCD displays as follows:

20
6.4 Select treatment program
Based on your needs, press [P] button to select the treat-
ment program. For each body part , it has 3 treatment pro-
grams. The LCD displays as follows:

6.5 Start treatment


Press the [+] button of CH1 to increase the channel 1 inten-
sity, press the [+] button of CH2 to increase the channel 2
intensity. The LCD displays as follows:

6.6 Adjust the output intensity


Place the electrodes on the body parts, press the [+] button
to increase output intensity. It will be increased to a higher
level after each press .The device has totally 60 levels of
output intensity. Please adjust the intensity to the condi-
tion that you feel comfortable. The level of output intensity
will be shown on the LCD:

If you feel it too strong, you can press [-] button to decrease
the intensity to a lowere level each time. When the output
21
intensity of both channels decrease to zero, the stimulator
will return to the standby mode. The LCD displays as fol-
lows:

Caution:
If you feel or become uncomfortable, reduce the stimu-
lation intensity to a more comfortable level and consult
with your medical practitioner if problems insist.

6.7 Pause the treatment


On the treating mode, press the [Q] button to pause the
treatment, and the LCD will display the icon . Press the [Q]
button again to regain the treatment.

6.8 Stop the treatment and turn off the device


Press the [ON/OFF] button to stop treatment during the
treating mode. Press the [ON/OFF] button again to turn off
the stimulator, and the LCD will be blank.

22
6.9 Load detection
It will automatically detect the load if the intensity is above
Level 9.If it haven’t detected the load or the electrode con-
tacts the skin not well enough ,the intensity will automati-
cally return to Level 0 and the symbol twinkles. And the
stimulator returns to the standby mode.

6.10 Query the treatment records


If you want to query the treatment records, press the [Q]
button to check the details. The LCD will show as follows:

Press the [+] button or [-] button to view the treatment his-
tory.
Press the [on/off] button to return to the standby mode.

6.11 Low battery detection


When the battery is low, the icon will twinkle to indi-
cate it. You should follow the Section 5.1.1 to replace bat-
teries.

23
Notice of batteries:
a. Batteries may be fatal if swallowed. Therefore, keep the
batteries and the product out of the reach of children. If a
battery is swallowed, go to a hospital immediately.
b. If there’s battery leakage, avoid contact with skin, eyes
and mucus membranes. Rinse the affected spots with
plenty of clear water immediately and contact a physi-
cian right away.
c. Batteries must not be charged, dismantled, thrown into
fire or short-circuited.
d. Protect batteries from excess heat. Take the batteries out
of the device if they are spent or in case that you will no
longer use the them. This prevents damage caused by
leaking batteries.

6.12 Sound prompt function


a. In the waiting state, when the sound prompt function
is on, press and hold the [B] button, and the device will
emit a long ‘DI’ to turn off the sound prompt function.
b. In the waiting state, when the sound prompt function
is off, press and hold the [B] button, and the device will
make two short “DI” to turn on the sound prompt
function.
Note: Reinstall the battery and the sound prompt func-
tion is turned on.

6.13 Usage of electrode pads


a. The electrode may only be connected with the COMBO
stimulator. Make sure that the device is turned off when
attaching or removing the electrode pads.
b. If you want to reposition the electrode during the appli-
cation, turn the device off first.
c. The use of electrode may lead to skin irritations. If you
experience such skin irritations, e.g. redness, blistering or
itching, discontinue using them. Do not use the COMBO
stimulator permanently on the same body part, as this
may also lead to skin irritations.

24
d. Electrode pads are private and intended for single per-
son use. Please avoid use them by different persons.
e. The electrode must connect entirely to the skin surface
to prevent hot spots, which may lead to skin burns.
f. Do not use the electrode pads for more than approx. 10
times, as connection between the electrodes and the
skin deteriorates over time.
g. The adhesive force of the electrodes depends on the
skin properties, storage condition, and the number of
applications. If your electrode pads no longer fully stick
to the skin’s surface, replace them with new ones. Stick
the electrode pads back onto the protective foil after use
and store them in the storage bag to prevent them from
drying out. This retains the adhesive force for a longer
period.

Caution:
1) Before applying the electrode, it is recommended for us-
ers to wash and degrease the skin, and then dry it.
2) Never remove the electrode from the skin while the de-
vice is still on.
3) Only use the electrode pads provided by the manufac-
turer. Use of other companies’ products could result in
injuries to the user.

6.14 Where do I attach electrode pads?


a. Each person reacts differently to electric nerve stimula-
tion. Therefore, the placement of the electrodes may
deviate from the standard. If application is not success-
ful, contact your physician to find out which placement
techniques are best for you.
b. Do not use any adhesive electrodes with a size smaller than
those the original manufacturer attached.Otherwise the
current density may be too high and cause injuries.
c. The size of the adhesive pads may not be changed, e.g.
by clipping off parts of them.
d. Make sure that the region radiating the pain is enclosed
by the electrodes. In case of painful muscle groups, at-

25
tach the electrodes in such a way that the affected mus-
cles are also enclosed by the electrodes.

Usage advice for TENS:


a) If you feel the output intensity too strong, you can press
【-】button to decrease it;
b) During the treatment if you don’t feel any discomfort,
we advise you use the device until the session ends. Nor-
mally, the pain relief occurs after 5~10 mins treatment;
c) Normally, we advise 1~2 treatments per day and one
week as a period of treatment;
d) After a period of treatment, if the pain relief is not
achieved or the pain gets even worse, please consult
your doctor.

Usage advice for EMS:


a) Place the electrodes on the body part you want to treat
referring to the picture on Section 5.4.3;
b) 1~2 treatment per day, about one week as a period of
treatment;
c) We advise you use the device for one session per time.
If you feel discomfort during treatment, you can either
pause the session or decrease the intensity of the out-
put.

7. Program

7.1 Treatment program


In TENS mode

Appli- Pro- Wave- Pulse Treat


Frequency
cable gram form Width time
parts (Hz) (uS) (Min.)
P1 FM 2/4/6 250 30
Shoul-
P2 FM 4/5/6/8 250 30
der
P3 FM&PM 2-125 100-200 30

26
P1 FM 60/50/45/35/10 200 30
Back P2 FM 6/8/10 250 30
P3 Han 55 330/150 30
P1 Normal 2 250 30
Arm P2 Han 2/100 200/150 30
P3 Normal 100 200 30
P1 Normal 100 150 30
Hip P2 FM 4/6/50 250 30
P3 Normal 100 200 30
P1 FM 4/6/50 250 30
Leg P2 Burst 100 150 30
P3 FM 6/8/10 250 30
P1 Han 2/100 200/150 30
Joint P2 Normal 100 150 30
P3 Burst 80 150 30

In EMS mode
Frequency (Hz)
Applica- Pro- Pulse Treatment
ble parts gram Prepare Work Relax width (uS) time (min.)
stage stage stage

P1 5 55/6 3 280 28
Shoul-
P2 5 75/4 3 280 32
der
P3 5 110/1 3 280 30

P1 5 55/6 3 300 28

Back P2 5 75/4 3 300 32

P3 5 110/1 3 300 30

P1 5 55/6 3 200 28

Arm P2 5 75/4 3 200 28

P3 5 110/1 3 200 28

27
P1 5 55/6 3 300 28
Hip P2 5 75/4 3 300 32
P3 5 110/1 3 300 30
P1 5 55/6 3 380 28
Leg P2 5 75/4 3 380 32
P3 5 110/1 3 380 30

In massage mode

Applica- Pro- Frequency Pulse Treatment


ble parts gram (Hz) width (uS) time (min.)
Knead P1 83-132 50-220 30
Rub P2 25-80 30-220 30
Tap P3 150-290 30-220 30

8. Cleaning and maintenance

Fully comply with the following necessary daily mainte-


nance requirements to make sure the device is intact and
guarantee its long term performance and safety.
8.1 Cleaning and care for the device
8.1.1Pull the electrodes out of the stimulator, remove the
batteries and clean the device with a soft, slightly
damp cloth. In case of heavier dirt build-up, you may
also apply a mild detergent.
8.1.2 Do not expose the COMBO stimulator to moisture or
dampness. And do not hold the COMBO stimulator
under running water, nor submerge it in water or oth-
er liquids.

28
8.1.3 The COMBO stimulator is sensitive to heat and may
not be exposed to direct sunlight. And do not place it
on hot surfaces.
8.1.4 Clean the surface of the electrode pads carefully with
a damp cloth. Make sure the device is turn off!
8.1.5 For reasons of hygiene, each user should use his/her
own set of electrodes.
8.1.6 Do not use any chemical cleaners or abrasive agents
for cleaning.
8.1.7 Ensure that no water penetrates into the machine.
Should this happen, use the device again only when it
is completely dry.
8.1.8 Do not clean the device during treatment. Be sure that
the device is turned off and the battery is unloaded
before cleaning.

8.2 Maintenance
8.2.1 The manufacturer didn’t authorize any maintenance
agencies abroad. If your device has any problem,
please contact the distributor. The manufacturer will
not be responsible for the results of maintenance or
repairs by unauthorized persons.
8.3.2 The user must not attempt any repairs to the device or
any of its accessories. Please contact the retailer for
repair.
8.3.3 Opening of the equipment by unauthorized agencies
is not allowed and will terminate any claim to warran-
ty.

Each product in manufacturing has been through the sys-


tematic validation. The performance is stable and does not
need to undertake calibration and validation.
If your product can’t reach the expected performance and
the basic function has changes in normal use, please con-
tact the retailer.
29
9. Troubleshooting

Should any malfunction occur while using the device,


check whether the parameters are set appropriately for
therapy, and adjust the control correctly. Please see the fol-
lowing table:

Malfunction Common reasons Countermeasure

1. Check and clean the


1.There’s foreign body
compartment.
in the battery com-
partment.
2. Replace the new
2.The battery has been
battery or install the
used up or installed
battery correctly.
oppositely.
3. Check and clean the
No display af- 3. There is foreign body
interface.
ter replacing in the battery inter-
the battery. face.
4. The battery is not the 4. Replace the battery
right model or some- with the right model.
thing goes wrong
with the battery
interface
5. Exception reset

1. The electrode does 1. Check and re-paste it


not connect well to on skin.
the skin.
No sensation 2. If the connect 2.Check the connec-
of stimulation between electrode tion..
or weak connect well to the
stimulation stimulator. 3. Replace the battery.
3. The battery is used 4. Wipe the electrode
up. and the skin with a
4. The skin is too dry. wet cotton cloth.

30
1. The electrode loses
1. Check and place the
Automatic connection with the
electrode properly
halt in the skin.
on the skin.
treatment 2. If the battery is used
2. Replace the battery.
up.

1. Do the treatment
once a day and
shorten the treat-
ment time.
1.The treatment time 2. Check and stick the
lasts too long. electrode well.
2.The electrode does 3. Wipe the electrode
Rash or tickle not stick well to the with a wet cotton
on the skin skin. cloth before use.
occurs in 3. The interface of the 4. Check your aller-
treatment electrodes is dirty or gic history. Please
dry. change the sticking
4. The skin is sensitive place or shorten the
to the electrode. treatment time .If
your skin is over-sen-
sitive, you should
stop the treatment
or go to see a doctor.

10. Storage

Remove the batteries from the device if you are not going
to use it for a long period. Battery leakage can damage the
unit. Do not make any sharp pull-out between the con-
nection of the leadwires and the electrodes. After use, put
the electrode away in the original package. Do not expose
the device to direct sunlight and protect it against dirt
and moisture. Store the machine in a cool, well-ventilated
place. Never place any heavy objects over the machine.
31
11. Disposal

Spent batteries do not belong to the household wastes.


Dispose of the battery according to the current regulations.
As a consumer, you have the obligation to dispose of bat-
teries correctly. Consult your municipal authority or your
dealer for information about disposal.
At the end of the product lifecycle, do not throw this prod-
uct into the normal household garbage, but bring it to a
collection point for the recycling of electronic equipment.
Obsolete electrical and electronic equipment may have
potentially harmful effects on the environment. Incorrect
disposal can cause toxins to build up in the air, water and
soil and jeopardize human health.

12. Electromagnetic compatibility (EMC)


tables
Guidance and manufacture’s declaration - electromagnetic emis-
sions
The device is intended for use in the electromagnetic environment
specified below. The customer or the user has to assure that it is
used in such environment.
Emissions test Compliance Electromagnetic environment - guidance
The device uses RF energy only for
its internal function. Therefore, its RF
RF emissions
Group 1 emissions are very low and are not
CISPR11
likely to cause any interference in
nearby electronic equipment.

32
RF emissions
Class B
CISPR11
The device is suitable for use in all es-
Harmonic emis-
Not appli- tablishments including those directly
sions
cable connected to the public low-voltage
lEC61000-3-2
power supply network that supplies
Voltage fluctua-
to buildings power used for domestic
tions/ Not appli-
purposes
Ficker emissions cable
lEC61000-3-3
Guidance and manufacture’s declaration — electromagnetic
immunity
The device is intended for use in the electromagnetic environment
specified below. The customer or the user of the device should
assure that it is used in such environment.
Electromagnetic
IEC 60601 Compliance
Immunity test environment-guid-
Test level level
ance
Floors should be
±8kV direct ±8kV direct wood, concrete or
Electrostatic & indirect & indirect ceramic tile. If floors
discharge (ESD) contact; contact; are covered with
lEC61000-4-2 ±15kV air ±15kV air synthetic material,
discharge discharge the relative humidity
should be at least 30%
not applicable
Electrical fast ±2 kV for
not applica- (for INTERNALLY
transient/burst power
ble POWERED ME
IEC 61000-4-4 supply lines
EQUIPMENT)
not applicable
Surge ± 1 kV line(s) not applica- (for INTERNALLY
IEC 61000-4-5 to line(s) ble POWERED ME
EQUIPMENT)

33
<5% UT
(>95% dip in
UT)
for 0.5 cycle

40% UT
Voltage dips, (60% dip in
short interrup- UT)
not applicable
tions and volt- for 5 cycles
not applica- (For INTERNAL-
age variations
ble LY POWERED ME
on power supply 70% UT
EQUIPMENT
input lines (30% dip in
IEC 61000-4-11 UT)
for 25 cycles

<5% UT
(>95% dip in
UT)
for 5 sec
Power frequency mag-
netic fields should be
Power frequency
at levels characteristic
(50Hz/60Hz)
10V/m 10V/m of a typical location in
magnetic field
a typical commercial
IEC 61000-4-8
or hospital environ-
ment.
NOTE   UT is the a.c. mains voltage prior to application of the test
level.
Guidance and manufacture’s declaration – electromagnetic im-
munity
The device is intended for use in the electromagnetic environment
specified below. The customer or the user of device should assure
that it is used in such an environment.
IEC
Immunity 60601 Compli- Electromagnetic environment -
test test ance level guidance
level

34
Radiated 10V/m 10V/m & Portable and mobile RF communi-
RF & table table 9 cations equipment should be used
IEC 9 not closer to any part of the Blood
61000-4-3 Pressure Monitor, including cables,
than the recommended separation
distance calculated from the equa-
tion applicable to the frequency of
the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation distance
in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the compliance
level in each frequency range.b
Interference may occur in the vicin-
ity of equipment marked with the
following symbol:

NOTE 1       At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2       These guidelines may not apply in all situations. Elec-
tromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

35
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If
the measured field strength in the location in which the
Blood Pressure Monitor is used exceeds the applicable RF
compliance level above, the Blood Pressure Monitor should be
observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as
reorienting or relocating the Blood Pressure Monitor.
b Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than [Vi] V/m.
Test specifications for ENCLOSURE PORT IMMUNITY to RF
wireless communications equipment (Table 9)
Maxi- Immu-
Test fre- Dis-
Band a) Modula- mum nity Test
quency Service a) tance
(MHz) tion b)
power Level (V/
(MHz) (m)
(W) m)
Pulse
380- modu-
385 TETRA 400 1.8 0.3 27
390 lation b)
18Hz
FM c)
430- GMRS 460, ±5kHz
450 2 0.3 28
470 FRS 460 deviation
1kHz sine
710 Pulse
745 704- LTE Band 13, modu-
0.2 0.3 9
787 17 lation b)
780 217Hz
810 GSM800/900,
Pulse
870 TETRA 800,
800- modu-
iDEN 820, 2 0.3 28
960 lation b)
930 CDMA 850,
18Hz
LTE Band 5
1720 GSM1800;
1845 CDMA 1900; Pulse
1700- GSM 1900; modu-
2 0.3 28
1990 DECT; LTE lation b)
1970 Band 1,3, 217Hz
4,25; UMTS

36
Bluetooth,
Pulse
WLAN,
2400- modu-
2450 802.11 b/g/ 2 0.3 28
2570 lation b)
n, RFID 2450,
217Hz
LTE Band 7
5240 Pulse
5500 5100- WLAN 802.11 modu-
0.2 0.3 9
5800 a/n lation b)
5785 217Hz
NOTE If it is necessary to achieve the IMMUNITY TEST LEVEL,
the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m.The 1 m test
distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are in-
cluded.
b) The carrier shall be modulated using a 50 % duty cycle
square wave signal.
c) As an alternative to FM modulation, 50 % pulse mod-
ulation at 18 Hz may be used because it does not rep-
resents actual modulation. It would be worst case.

13. Normalized symbols


Electrical devices are recyclable material and
should not be disposed of with household
waste after use! Help us to protect the environ-
ment and save resources and take this device
to the appropriate collection points. Please
contact the organization which is responsible
for waste disposal in your area if any question.

Applied part of type BF

Refer to instruction manual

37
The first number 2: Protect against solid for-
eign objects of 12,5 mm Ф and greater. The
second number: Protect against vertically
IP22 falling water drops when enclosure titled up to
15º. Vertically falling drops shall have no harm-
ful effects when the enclosure is titled at any
angle up to 15º, on either side of the vertical.

Manufacturer information: The manufacturer


Shenzhen Roundwhale Technology Co., LTD.

Manufacture date

14. WARRANTY

Please contact your dealer or the device centre in case of a


claim under the warranty. If you have to return the unit, en-
close a copy of your receipt with clear statement of defect
description.
The warranty terms is below:
1. The warranty period for this device is 1 year from date of
purchase. In case of a warranty claim, the date of pur-
chase has to be proven by means of the sales receipt or
invoice.
2. Repairs under warranty should be in the warranty period
either for the device or for the replacement parts.
3. The following cases are excluded under the warranty
• All damages that arise due to improper operation, e.g.
nonobservance of the user instruction.
• All damages due to repairs or tampering by the cus-

38
tomer or unauthorized third parities.
• Damage which has arisen during transport from the
manufacturer to the consumer or the service centre.
• Accessories which are subject to normal wear and tear.
• Device damage due to privately dissembling devices.
4. Liability for direct or indirect consequential losses
caused by the unit is excluded even if the damage to the
unit is accepted as a warranty claim

39
Shenzhen Roundwhale Technology Co., Ltd.
Add: 202, 2/F, Building 27,Dafa Industrial Park,longxi
community, longgang street, longgang district,
Shenzhen, China.
Tel: +86-755-23212776
Fax: +86-755-23212776
E-mail: info@roovjoy.com

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