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Combo Electrotherapy Device Manual

The instruction manual for the Combo Electrotherapy Device Model CMX02T provides essential information on its operation, safety precautions, and specifications. It details the device's capabilities in TENS, EMS, and massage modes, along with important safety warnings and contraindications for use. The manual emphasizes the need for careful reading and adherence to instructions to ensure safe and effective use of the device.

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0% found this document useful (0 votes)
30 views45 pages

Combo Electrotherapy Device Manual

The instruction manual for the Combo Electrotherapy Device Model CMX02T provides essential information on its operation, safety precautions, and specifications. It details the device's capabilities in TENS, EMS, and massage modes, along with important safety warnings and contraindications for use. The manual emphasizes the need for careful reading and adherence to instructions to ensure safe and effective use of the device.

Uploaded by

alidalegg25
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

INSTRUCTION MANUAL

FOR
Combo Electrotherapy Device
Model: CMX02T

Be sure to read this instruction manual before operate and


keep it where safe.
Caremax Australia 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.


CMX02T Rev.V1.0© 2022, printed in July. 14, 2022.

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.

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 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-

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.

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.

1.2.4 WHAT IS MASSAGE ?


The massage function is non-medical function. The Mas-
sage stimulation program provides relaxing muscle vibra-
tion to loosen tight muscles.

5
2. SAFETY INFORMATION

2.1 Intended use


TENS mode
It is used for temporary relief of pain associated with sore
and aching muscles in the neck, shoulder, back, joint, hip,
hand, abdomen, foot, upper extremities (arm) and lower
extremities (leg) due to strain from exercise or normal
household work activities.

It is also intended for symptomatic relief and management


of chronic, intractable pain and relief of pain associated
with arthritis.

EMS mode
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to
prevent venous thrombosis
6. Maintaining or increasing range of motion

The device can be used at home or hospital, using the ob-


ject (patient) must be 18 years or older of adults.

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.

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 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, 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 transcerebrally
(through the head).
5) This device should not be used in overly enervated ar-
eas.
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.

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.

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 TENS 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.

3. GETTING TO KNOW YOUR DEVICE

3.1 Accessories

No. Description QTY


1 Combo Electrotherapy Device 1PC
2 Electrode pad (50mm×50mm ) 4PCS

11
3 Electrode wires 2PCS
4 USB cable 1PC
5 User manual 1PC

3.2 LCD display

No. Function description No. Function description


1 Treatment mode 9 Indicator of no load ( Channel 1
and Channel2 )
2 Symbol of Program 10 Intensity for Channel2

3 Low battery symbol 11 Symbol of Channel 2

4 Symbol of SET 12 Symbol of treatment time


(min)
5 Program number 13 Symbol of pulse width (uS)

6 Symbol of Channel 1 14 Symbol of pulse rate (Hz)

7 Intensity for Channel 1 15 Treatment time

8 Key locking symbol 16 Timer sign

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

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.

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 advantage of stimulating two
different areas at the same time.

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.

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.

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.

5.3.3 Electrode placement


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

18
Hand

Back
1 2
2

Abdomen

Hip

Leg

1 2

Foot

19
Joint
(Knee)

Joint
(Elbow)

Joint
(Ankle)

Joint
(Wrist)

Position of electrode placement under EMS programs

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.

6.2 Select treatment mode


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

6.3 Select treatment program


Based on your need, press [P] button to select the treat-
ment program. The LCD displays as follows:

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:

2) In the program U1 to U3, press [P] button to adjust pulse


rate -> pulse width -> treatment time by setting the param-
eter.
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

Press [ON/OFF/M] button to return to the standby mode.

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:

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:

The lock function automatically activates after there is no


operation in the panel for 20 seconds while in treatment
status. The indicator “ ” will display on the LCD. This
is a safety feature to prevent accidental changes to your
settings and to prevent accidentally increasing the output
intensity level. Press [CH1-] or [CH2-] button to unlock..

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.

6.7 Stop the treatment and turn off the device


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

6.8 Load detection


It will automatically detect the load if the intensity is above
level 5. If it hasn’t detected the load or the electrode con-
tacts the skin not well enough, the intensity will automat-
ically return to level 0 and the symbol ‘ ’ twinkles. And
the stimulator returns to the standby mode.

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.

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.

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.

6.10 Usage of electrode pads


1. 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.
2. If you want to reposition the electrode during the appli-
cation, turn the device off first.
3. The usage 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.
4. Electrode pads are private and intended for single person
use. Please avoid using them by different persons.
5. The electrode must connect entirely to the skin surface
to prevent hot spots, which may lead to skin burns.
6. Do not use the electrode pads for more than approx. 10
times, as connection between the electrodes and the
skin deteriorates over time.
7. 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

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.

6.11 Where do I attach electrode pads?


1. Each person reacts differently to electric nerve stimu-
lation. 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.
2. Do not use any adhesive electrodes with a size smaller
than those the original manufacturer attached. Other-
wise the current density may be too high and cause inju-
ries.
3. The size of the adhesive pads may not be changed, e.g.
by clipping off parts of them.
4. Make sure that the region radiating the pain is enclosed
by the electrodes. In case of painful muscle groups, at-
tach the electrodes in such a way that the affected mus-
cles are also enclosed by the electrodes.

Usage advice for TENS:


1) If you feel the output intensity too strong, you can press [-]
button to decrease it;

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.

Usage advice for EMS:


1) Place the electrodes on the body part you want to treat
referring to the picture on Section 5.3.3;
2) 1~2 treatment per day, about one week as a period of
treatment;
3) We advise you to 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 output.

7. 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..

7.1 Cleaning and care for the device


7.1.1 Pull the electrodes out of the stimulator, clean the
device with a soft, slightly damp cloth. In case of
heavier dirt build-up, you may also apply a mild dete
rgent.
7.1.2 Do not expose the COMBO stimulator to moisture or
dampness. And do not hold the COMBO stimulator

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.

Each product in manufacturing has been through the sys-

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

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
The battery is exhaust- Charge in time
No display
ed
1. The electrode does
not connect well to 1. Check and re-paste it
the skin. on skin.
No sensation 2. If the connection 2. Check the connec-
of stimulation between electrode tion.
or weak connects well to the 3. Charge.
stimulation stimulator. 4. Wipe the electrode
3. The battery is used and the skin with a
up. wet cotton cloth.
4. The skin is too dry.
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. Charge
up.

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

9.1 Storing the Electrode Pads and Lead Wires


1. Turn the device off and remove the lead wires from the
unit.
2. Remove the electrodes from your body and disconnect
the lead wires from the electrodes.
3. Place the electrodes into the plastic film and then store
into the sealed package.
4. Wrap the lead wires and store into the sealed package.

9.2 Storing the Unit


1. Place the unit, electrodes, lead wires and manual back
into the gift box. Store the box in a cool, dry place, -10℃

33
~ 55℃ ; 10% ~ 90% relative humidity.
2. Do not keep in places that can be easily reached by chil-
dren

10. DISPOSAL

Spent batteries do not belong to the household


wastes. Disposal of the battery according to the
current regulations. As a consumer, you have
the obligation to dispose of batteries 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.

11. 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

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

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.
IEC 60601 Compliance Electromagnetic
Immunity test
Test level level environment-guidance
Floors should be
±8kV direct ±8kV direct wood, concrete or
Electrostatic & indirect & indirect ceramic tile. If floors
discharge (ESD) contact; contact; are covered with
IEC61000-4-2 ±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)

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

Voltage dips, 40% UT


short interrup- (60% dip in 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 UT)
IEC 61000-4-11 for 25 cycles

<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).

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:

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.

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
704- LTE Band 13, modu-
745 0.2 0.3 9
787 17 lation b)
780 217Hz

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.

Applied part of type BF

Refer to instruction manual

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.

Month

Manufacturer information

Manufacture date

40
13. WARRANTY

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


claim under the warranty. If you have to return the unit, en-
closing a copy of your receipt with clear statement of defect
description.

The warranty terms are as 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-
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 damages 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.

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]

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