Combo Electrotherapy Device Manual
Combo Electrotherapy Device Manual
FOR
Combo Electrotherapy Device
Model: CMX02T
Declaration of conformity:
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
TABLE OF CONTENS
1. FOREWORD 4
2. SAFETY INFORMATION 6
3. GETTING TO KNOW YOUR DEVICE 11
4. SPECIFICATION 14
5. OPERATING INSTRUCTION 16
6. INSTRUCTIONS FOR USE 22
7. CLEANING AND MAINTENAN CE 30
8. TROUBLESHOOTING 32
9. STORAGE 33
10. DISPOSAL 34
11. ELECTROMAGNETIC COMPATIBILITY(EMC) TABLES 34
12. NORMALIZED SYMBO LS 40
13. WARRANTY 41
1. FOREWORD
1.1 Introduction
The device CMX02T 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.
4
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.
5
2. SAFETY INFORMATION
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
6
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.
7
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, whice becomes more than
mild, or lasts for more than five days, stop using the de-
vice 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.
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 stimu-
lation are unknown. Electrical stimulation
device cannot replace drugs.
8
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 affect
the output power of the stimulator.
14) Never use it near the cardiac area. Stimulation elec-
trodes 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
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.
9
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 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
10
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.
3.1 Accessories
11
3 Electrode wires 2PCS
4 USB cable 1PC
5 User manual 1PC
12
3.3 Device illustration
11
9
8
2
3 5
4 6 10
7
No. Description
1 LCD display
2 [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 treat-
ment mode; press and hold the [ON/OFF/M] button to turn off the
device;
At treating mode, press the [ON/OFF/M] button to stop the treat-
ment.
At setting mode, press the [ON/OFF/M] button to enter the standby
mode.
3 [+] button:
At standby or treating mode, press the [+] button to increase the in-
tensity of CH1 ;
At setting mode, press the [+] button to increase the corresponding
data for the pulse rate, pulse width and treatment time.
13
4 [-] button:
At treating mode, press the [-] button to decrease the intensity of
CH1.
At setting mode, press the [-] button to decrease the corresponding
data for the pulse rate, pulse width and treatment time.
At the key locking mode, press the [-] button to unlock the keys.
5 [+] button:
At standby or treating mode, press the [+] button to increase the in-
tensity of CH2 ;
At setting mode, press the [+] button to increase the corresponding
data for the pulse rate, pulse width and treatment time.
6 [-] button:
At treating mode, press the [-] button to decrease the intensity of
CH2.
At setting mode, press the [-] button to decrease the corresponding
data for the pulse rate, pulse width and treatment time.
At the key locking mode, press the [-] button to unlock the keys.
7 [P] button:
At standby mode, press the [P] button to select the treatment pro-
gram; press and hold the [P] button to enter the setting mode.
At setting mode, press [ P] button to select pulse rate, pulse width or
treatment time
8 Charger indicator:
When the device is charging, the indicator light will be yellow.
When charging is completed, the indicator light will be green.
9 USB socket
10 Output socket
11 Blet Clip
4. SPECIFICATION
4.1Technical information
Device name Combo Electrotherapy Device
Model/type CMX02T
Power sources 3.7 V Li-ion battery
14
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
N u m b e r o f p r o - 22 programs
grams TENS : 9 programs;EMS: 8 programs;
MASSAGE: 5 programs
Pulse rate 2Hz ~ 100Hz
Pulse width 100uS ~ 300uS
Treatment time 5 minutes ~ 90 minutes
Operating condi- 5° C to 40° C with a relative humidity of 15%-93%,
tion 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 70g (without batteries)
Automatic shutoff 1 minutes
Classification BF type applied part, internal power equipment, IP22
Size of electrodes pad 50x50mm, square
Output precision ±20% error is allowed for all the output pa-
rameters
Device service life 2 years
Electrode pads re- 10-15 times
use life
Software version V1.0
15
5. OPERATING INSTRUCTION
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.
Caution
Do not insert the plug of the electrode wires into any AC
16
power supply socket.
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 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.
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.
17
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 unwant-
ed irritation.
5. It is recommended that, at minimum, 1.97”x 1.97” self-ad-
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.
Neck
Shoulder
Arm
18
Hand
Back
1 2
2
Abdomen
Hip
Leg
1 2
Foot
19
Joint
(Knee)
Joint
(Elbow)
Joint
(Ankle)
Joint
(Wrist)
Neck
2
1 2 1
1 2
Shoulder 1
20
Arm
Hand
Back
Abdomen 1
1 2
Hip
Leg
Foot
21
6. INSTRUCTIONS FOR USE
6.1 Turn on
Press the [ON/OFF/M] button to turn on the device, the LCD
will be lit. And then it goes into the standby mode as the
picture shown below.
22
6.4 Select program parameter
Press and hold [P] button to enter the setting mode.
1) In the program P1 to P6 of the TENS mode and the pro-
gram P1 to P5 of the EMS mode, press [+]/[-] button to ad-
just treatment time.
The LCD displays as follows:
23
Press [+]/[-] button to adjust corresponding data.
Treatment Program Treatment Frequency Pulse width
mode NO. time (min) (Hz) (uS)
TENS U1 Default:30 Default:50 Default:180
Adjustable: Adjustable: Adjustable:
5-90 2-100 100-300
U2 Default:30 Default:60 Default:160 -
Adjustable: Adjustable: 260
5-90 2-100 Adjustable:
100-300
U3 Default:30 Default:50 Default:100
Adjustable: Adjustable: Adjustable:
5-90 2-100 100-300
EMS U1 Default:30 Default:5 Default:300
Adjustable: Adjustable: Adjustable:
5-90 2-100 100-300
U2 Default:30 Default:60 Default:200
Adjustable: Adjustable: Adjustable:
5-90 20-100 100-300
U3 Default:30 Default:70 Default:200
Adjustable: Adjustable: Adjustable:
5-90 20-100 100-300
24
6.6 Adjust the output intensity
Press the [+] button to increase output intensity. It will be
increased to a higher level after each press. The device has
totally 40 levels of output intensity. Please adjust the inten-
sity to the condition 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 lower level each time. When the output
intensity of both channels decrease to zero, the stimulator
25
will return to the standby mode. The LCD displays as fol-
lows:
Caution:
If you feel or become uncomfortable, reduce the stimula-
tion intensity to a more comfortable level and consult with
your medical practitioner if problems insist.
26
6.9 Low battery detection
When the battery is low, the icon will twinkle to indi-
cate it, stop the device and charge the battery.
27
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.
28
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. Usage of other companies’ products could result in
injuries to the user.
29
2) If you don’t feel any discomfort during the treatment, we
advise you to use the device until the session ends. Nor-
mally, the pain relief occurs after 5~10 mins treatment;
3) Normally, we advise 1~2 treatments per day and one
week as a period of treatment;
4) After a period of treatment, if the pain relief is not
achieved or the pain gets even worse, please consult
your doctor.
30
under running water, nor submerge it in water or oth-
er liquids.
7.1.3 The COMBO stimulator is sensitive to heat and may
not be exposed to direct sunlight. And do not place it
on hot surfaces.
7.1.4 Clean the surface of the electrode pads carefully with
a damp cloth. Make sure the device is turn off!
7.1.5 For reasons of hygiene, each user should use his/her
own set of electrodes.
7.1.6 Do not use any chemical cleaners or abrasive agents
for cleaning.
7.1.7 Ensure that no water penetrates into the machine.
Should this happen, use the device again only when it
is completely dry.
7.1.8 Do not clean the device during treatment. Be sure that
the device is turned off and the battery is unloaded
before cleaning.
7.2 Maintenance
7.2.1 The manufacturer didn’t authorize any maintenance
agencies abroad. If your device has any problems,
please contact the distributor. The manufacturer will
not be responsible for the results of maintenance or
repairs by unauthorized persons.
7.2.2 The user must not attempt any repairs to the device or
any of its accessories. Please contact the retailer for
repair.
7.2.3 Opening of the equipment by unauthorized agencies is
not allowed and will terminate any claim to warranty.
31
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 changed in normal use, please con-
tact the retailer.
8. TROUBLESHOOTING
32
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
not stick well to the
Rash or tickle with a wet cotton
skin.
on the skin cloth before use.
3. The interface of the
occurs in the 4. Check your aller-
electrodes is dirty or
treatment 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.
9. STORAGE
33
~ 55℃ ; 10% ~ 90% relative humidity.
2. Do not keep in places that can be easily reached by chil-
dren
10. DISPOSAL
34
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.
RF emissions
Class B
CISPR11
Harmonic emis- The device is suitable for use in all es-
Not appli-
sions tablishments including those directly
cable
IEC61000-3-2 connected to the public low-voltage
Voltage fluctua- power supply network that supplies
tions/ to buildings power used for domestic
Not appli-
Flicker emis- purposes
cable
sions IEC61000-
3-3
35
not applicable
Surge ± 1 kV line(s) not applica- (for INTERNALLY
IEC 61000-4-5 to line(s) ble POWERED ME
EQUIPMENT)
<5% UT
(>95% dip in
UT)
for 0.5 cycle
<5% UT
(>95% dip in
UT)
for 5 sec
Power frequency mag-
Power frequency netic fields should be
(50Hz/60Hz) at levels characteristic
10V/m 10V/m
magnetic field of a typical location in
IEC 61000-4-8 typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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 device should assure
that it is used in such environment.
36
IEC
Immunity 60601 Compli- Electromagnetic environment -
test test ance level guidance
level
Portable and mobile RF communi-
cations equipment should be used
not closer to any part of the device,
including cables, than the recom-
mended separation distance calcu-
lated from the equation applicable
to the frequency of the transmitter.
Radiated Recommended separation dis-
10V/m
RF 10V/m & tance 80 MHz to 800
& table
IEC table 9 MHz 800 MHz to 2.5
9
61000-4-3 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).
37
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.
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 device is
used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If ab-
normal performance is observed, additional measures may be
necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than [Vi] V/m.
38
810
GSM800/900,
Pulse
TETRA 800,
800- modu-
870 iDEN 820, 2 0.3 28
960 lation b)
CDMA 850,
18Hz
LTE Band 5
930
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
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.
39
12. NORMALIZED SYMBOLS
Electrical devices are recyclable material and
should not be disposed of with household
waste after using! Help us to protect the en-
vironment and save resources and take this
device to the appropriate collection points.
Please contact the organization which is re-
sponsible for waste disposal in your area if any
questions.
Month
Manufacturer information
Manufacture date
40
13. WARRANTY
41
R-C4D : Treatment programs
Treatment time
Mode Program Pulse rate(Hz) Pulse width (us) Remark Applied
(min)
Neck, shoulder,
Default:30 Gate
P01 100 150 arm, elbow, back,
Adjustable:(5-90) control
hip and hand
Default:30 Gate
P02 60 200
Adjustable:(5-90) control Pain relief for low
Default:30 Low back muscles, arm
P03 15 260
Adjustable:(5-90) frequency and leg muscles
Default:30
P04 2-60 260-160 Modulation
Adjustable:(5-90)
TENS Default:30
P05 60/50/45/10/50/35 200 Modulation Neck, shoulder,
Adjustable:(5-90) arm, elbow, back,
Default:30
P06 40/6/50 200 Modulation hip and hand
Adjustable:(5-90)
Default:30 Default:50 Default:180 Gate
U1
Adjustable:(5-90) Adjustable:(2-100) Adjustable:(100-300) control Pain relief for low
Default:30 Default:60 Default:160-260
U2 Modulation back muscles, arm
Adjustable:(5-90) Adjustable:(2-100) Adjustable:(100-300)
and leg muscles
Default:30 Default:50 Default:100
U3 Acupuncture
Adjustable:(5-90) Adjustable:(2-100) Adjustable:(100-300)
Use after intense
Default:30 Active exercise to
P01 4 200
Adjustable:(5-90) Recovery promote recovery
and relaxation.
Default:30 Build
P02 20 200
Adjustable:(5-90) Endurance
Default:30 Muscle
P03 50 200
Adjustable:(5-90) Strengthen Body part muscle
Default:30 Muscle exercise
P04 60 200
Adjustable:(5-90) Strengthen
EMS
Default:30 Muscle
P05 50 200
Adjustable:(5-90) Strengthen
Use after intense
Default:30 Default:5 Default:300 Active exercise to
U1
Adjustable:(5-90) Adjustable:(2-100) Adjustable:(100-300) Recovery promote recovery
and relaxation.
Default:30 Default:60 Default:200 Muscle
U2
Adjustable:(5-90) Adjustable:(20-100) Adjustable:(100-300) Strengthen Body part muscle
Default:30 Default:70 Default:200 Muscle exercise
U3
Adjustable:(5-90) Adjustable:(20-100) Adjustable:(100-300) Strengthen
P01 30 8 300 Con.
P02 30 100 220 Con.
MASS Whole body part
P03 30 28~45 120~250 knead
AGE muscle exercise
P04 30 25~80 120~250 Rub
P05 30 50~100 100~240 Tap
文件编号:QR-12-234 版本:A/0
Manufactured for Caremax Australia by:
Le Reve Healthcare Pty Ltd AKA Caremax
Factory 28, 25-39 Cook Road
Mitcham Victoria Australia
Web: [Link]
Email: enquiries@[Link]