Body Clock 3-in-1 COMBO User manual

Instructions for use
3-in-1
COMBO
ELECTROTHERAPY
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Contents
1. Foreword......................................................................3
2. Safety information ................................................5
3. Getting to know your device .........................10
4. Specification ..........................................................13
5. Operating instructions ......................................14
6. Instructions for use ............................................. 21
7. Cleaning and maintenance .............................29
8. Troubleshooting ................................................... 31
9. Storage .....................................................................33
10. Disposal of device ................................................33
11. Electromagnetic compatibility
(EMC) tables ..........................................................34
12. Explanation of symbols ...................................40
13. Warranty ................................................................. 41
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1. Foreword
The 3-in-1 COMBO is a dual channel output TENS, EMS
and MASSAGE stimulator. Before using, please read all of
the instructions in this user manual carefully and keep it
safe for future reference.
The unit has three functions - TENS (Transcutaneous
Electrical Nerve Stimulation), EMS (Electronic Muscle
Stimulation) and MASSAGE.
The 3-in-1 COMBO stimulator has 22 programs (9 TENS
programs, 8 EMS programs and 5 MASSAGE programs).
Each program controls the generated electric impulses,
their intensity, frequency and pulse width.
Please see page 42 for a summary of the programs
available. The unit works by passing mild electrical
impulses through the skin, via electrode pads, into the
nerve and muscle fibres which lie below.
The intensity of the unit can be adjusted independently
and applied individually to one or more body parts. The
unit can be used with 4 self-adhesive electrodes, which
means that it will allow you to stimulate two muscle
groups simultaneously with a wide selection of standard
programs.
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1.2 GENERAL INFORMATION
1.2.1 About pain
Pain is felt in an injured area when messages travel to the
brain, along small nerves leading to the spinal cord.These
messages are then transmitted via other nerves that
travel up the spinal cord to the brain. At the brain, they
are decoded, analysed and reacted to.
1.2.2 What is TENS?
TENS (Transcutaneous Electrical Nerve Stimulation) can
be effective in the relief of pain. It can be used daily and
is clinically proven to be effective. High-frequency TENS
currents activate the pain-inhibiting mechanisms of the
nervous system. Electrical impulses from electrodes,
placed on the skin over or near the pain area, stimulate
the nerves to block the pain signals to the brain,
thus creating the perception of there being no pain.
Low-frequency TENS currents facilitate the release of
endorphins, the body’s natural painkillers.
1.2.3 What is EMS?
EMS stands for Electronic Muscle Stimulation. This
treatment consists of delivering electrical impulses
through the skin into the nerve fibres and muscles that
lie beneath. Skin contact is made via surface electrodes
placed on the body. The EMS unit will then stimulate
the muscles to contract and relax. EMS can be used
for toning and strengthening all muscle groups for
athletic training, bodybuilding and sports injuries, after
pregnancy, weight loss, cosmetic purposes, chronic back
pain and incontinence.
1.2.4 What is MASSAGE (in electrotherapy)?
This is very similar to TENS and EMS as explained above,
except the treatment consists of delivering electrical
impulses to relax muscles and decrease stress.
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2. Safety information
2.1 INTENDED USE
The 3-in-1 COMBO stimulator is specifically designed
for home use by adults. It is intended for the relief and
management of pain and the stimulation and massaging
of muscles. This unit provides the user with three modes.
1. TENS mode
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.
2. EMS mode
The EMS stimulation program stimulates muscles in order
to improve and facilitate muscle conditioning.
3. Massage mode
The Massage stimulation program provides muscle
relaxation to loosen tight muscles.
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2.2 IMPORTANT SAFETY PRECAUTIONS & WARNINGS
See page 40 for safety symbols. It is important that you
read all of 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.
2.2.1 Contraindications
1) Do not use this device if you are using a cardiac
pacemaker, implanted defibrillator, or other
implanted metallic or electronic devices. Such
use could cause electric shock, burns, electrical
interference, or death.
2) Stimulation should not be applied over swollen,
infected, inflamed areas or skin eruptions (e.g.
phlebitis, thrombophlebitis, varicose veins, etc.).
3) Electrode placements must be avoided in the carotid
sinus area (front and side of neck) or transcerebrally
(through the head).
4) Do not use if you have a suspected or diagnosed
Inguinal Hernia.
5) Do not use on scarred areas following a surgery for
at least 10 months after the operation.
6) Do not use with serious arterial circulatory problems
in the lower limbs.
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2.2.2 Warning
1) If you have had medical or physical treatment for
pain, consult with your physician before use.
2) If your pain has not lessened, or becomes more than
mild, then please consult with your physician.
3) Do not apply stimulation at the front or at the side
of your neck because this could cause severe muscle
spasms resulting in the closure of your airways,
difficulty breathing, or adverse effects on your heart
rhythm or blood pressure.
4) Do not apply stimulation across your chest because
the introduction of electrical currents into the chest
may cause rhythm disturbances to your heart, which
could be lethal.
5) Do not apply stimulation over, or in proximity to,
cancerous 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 the electrical stimulation device is in
use.
7) Do not apply stimulation when in the bath or
shower.
8) Do not apply stimulation while sleeping.
9) Do not apply stimulation while driving, operating
machinery, or during any activity when electrical
stimulation can put you at risk of injury.
10) Apply stimulation only to intact, clean, healthy skin.
11) The long-term effects of electrical stimulation are
unknown. The device cannot replace drugs.
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12) Stimulation should not take place while the user is
connected to high-frequency hospital equipment,
which may cause burn injuries on the skin under the
electrodes, as well as problems with the unit.
13) Do not use the unit in the vicinity of shortwave or
microwave therapy equipment since this may affect
the output power of the stimulator.
14) Never use the unit near the cardiac area. Stimulation
electrodes should never be placed anywhere on the
front of the thorax (marked by ribs and breastbone) or
the two large pectoral muscles due to the increased
risk of ventricular fibrillation which could lead to
cardiac arrest.
15) Never use on the eyes, head and face or genital areas.
16) Never use on skin areas lacking normal sensation.
17) Keep electrodes separated during treatment. Improper
stimulation or skin burns could result if electrodes are
in contact with each other.
18) Keep the stimulator out of reach of children.
19) Consult your doctor or supervisory medical
professional if you are in any doubt whatsoever.
20) Discontinue use if any discomfort is felt.
21) TENS must NOT be used before the 37th week of
pregnancy.
22) If you are pregnant, do NOT place the electrodes over
your abdomen.
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.
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3) TENS is a symptomatic treatment which suppresses
the sensation of pain that would otherwise serve as a
protective mechanism.
4) Effectiveness is highly dependent upon patient selection
by a practitioner qualified in the management of pain
patients.
5) Since the effects of stimulation of the brain are
unknown, 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 conductive
medium (gel). If this occurs please discontinue use.
8) If you have a 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 or fracture. Seek medical advice
before using this unit.
10) Consult with your physician prior to the use of the
device after a recent surgical procedure, because
stimulation may disrupt the healing process.
11) Proceed with caution if stimulation is intended to be
applied over the menstruating uterus.
12) Instructions for use in this manual should be followed
fully. Improper use may be dangerous.
13) Rare cases of skin irritation may occur at the site
of the electrode placement following long-term
application. Electrode pads should be re-located or use
discontinued.
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3. Getting to know your device
3.1 CONTENTS
1 x 3-In-1 COMBO unit
4 x Self adhesive electrodes
2 x Lead wires
3 x AAA Batteries
Instruction manual
14) Do not use this device in the presence of other
equipment which sends electrical pulses to your
body.
15) Do not use sharp objects such as a pencil or ballpoint
tip to operate the buttons on the control panel.
16) Check the electrode connections before each use.
17) This device should only be used with electrodes
recommended by Body Clock Health Care Ltd.
2.2.4 Adverse Reactions
1) Possible skin irritation or electrode burns under
the electrodes may occur. If so, discontinue use
immediately.
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 accustomed 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.
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No Function description No Function description
1 Treatment mode 9 Indicator of no load
(Channel 1 and Channel 2)
2 Program Identifier 10 Channel 2 indicator
3 Low battery indicator 11 Intensity for Channel 2
4Symbol of setting
function 12 Symbol of treatment time (min)
5 Program number 13 Pulse width indicator (uS)
6 Channel 1 indicator 14 Pulse rate indicator (Hz)
7 Intensity for Channel 1 15 Treatment time
8 Key locking symbol 16 Timer sign
3.2 LCD DISPLAY
3.3 DEVICE ILLUSTRATION
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No Description
1LCD display
2
[ON/OFF/M] button:
Press the [ON/OFF/M] button to turn on the device; in
standby mode, press the [ON/OFF/M]button to select the
treatment mode. Press and hold the [ON/OFF/M] button to
turn off the device; In treating mode, press the [ON/OFF/M]
button to stop the treatment.
3
CH1 [+] button:
Press the CH1 [+] button to increase the intensity of CH1;
Press the CH1 [+] button to increase the treatment time
(or to increase the pulse rate, and pulse width in the user
mode which is only relevant to the TENS and EMS treatment
modes).
4
CH1 [-] button:
Press the CH1 [-] button to increase the intensity of CH1;
Press the CH1 [-] button to increase the treatment time
(or to increase the pulse rate, and pulse width in the user
mode which is only relevant to the TENS and EMS treatment
modes).
5
CH2 [+] button:
Press the CH2 [+] button to increase the intensity of CH2;
Press the CH2 [+] button to increase the treatment time
(or to increase the pulse rate, and pulse width in the user
mode which is only relevant to the TENS and EMS treatment
modes).
6
CH2 [-] button:
Press the CH2 [-] button to increase the intensity of CH2;
Press the CH2 [-] button to increase the treatment time
(or to increase the pulse rate, and pulse width in the user
mode which is only relevant to the TENS and EMS treatment
modes).
7
[P] button:
On standby mode, press the [P] button to select the
treatment program. At standby mode, press and hold [P]
button to enter the setting mode.
8 Battery cover.
9 Jack plug socket.
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Device name 3-in-1 COMBO Electrotherapy Device
Power sources 4.5V D.C., 3x AAA batteries
Output channel Dual channel
Waveform Bi-phase square-wave pulse
Output current Max. 120mA (at 500ohm load)
Output intensity 0 to 40 levels, adjustable
Treatment mode TENS, EMS and MASSAGE mode
Operating 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 109 x 54.5 x 23mm (L x W x T)
Weight Approx 70g (without batteries)
Automatic Shut-off 1 minute
Classification BF type applied part, internal power equipment, IP22
Electrodes pads 50x50mm, square
Output precision ±20% error is allowed for all the output parameters
TENS MODE (9 PROGRAMS)
P.W. (Pulse Width) 100-300μs
P.R. (Pulse Rate) 2-120Hz (Hz=vibration per second)
Treatment time 5-90 minutes
EMS MODE (8 PROGRAMS)
P.W. (Pulse Width) 100μs-300μs
P.R. (Pulse Rate) 2-100Hz (Hz=vibration per second)
Treatment time 5-90 minutes
MASSAGE MODE (5 PROGRAMS)
P.W. (Pulse width) 5-90 minutes 100-250μs
P.R. (Pulse Rate) 8-100Hz (Hz=vibration per second)
Treatment time 30 minutes
4. Specification
4.1 TECHNICAL INFORMATION
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5. Operating Instructions
5.1 BATTERY
5.1.1 Check/replace batteries
Open the battery cover by pressing down on the flap;
insert three batteries (type AAA) into the battery
compartment. Take care when installing the batteries
noting the positive terminal (+) and negative terminal (-)
in the battery compartment of device. Ensure the unit is
switched off until you are ready to use it.
5.1.2 Disposal of batteries
Used batteries do not belong in household waste. As an
end user, you have a role to play in the recycling of used
batteries. Household batteries should be taken to your
nearest recycling centre or collection point.
1. If a battery is swallowed accidentally, please seek
medical assistance immediately!
2. In the case of battery leakage, please avoid contact
with the battery through skin, eyes and mucus
membranes. If contact occurs, please wash that body
part with plenty of clean water and contact your
doctor immediately.
3. Please do not short circuit, dismantle or throw the
batteries into fire.
4. Protect batteries from excess heat; take the batteries
out of the product if they have run out or if the
device will not be used for a long period of time. This
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can prevent the device from being damaged due to
the battery leakage.
5. Always replace the device with the same type of
batteries.
5.2 SETTING UP YOUR 3-IN-1 COMBO
Take the two black leadwires and insert each of the jack
plugs (at one end of each leadwire) into the sockets at
the top of the 3-in-1 COMBO unit.
Now insert the pins (at the other end of the leadwires)
into the sockets attached to the sticky electrodes. Each
leadwire has two pins, ensure each pin is attached to
an electrode. Do not remove the electrodes from the
backing at this stage. Please refer to picture below.
Caution
Always use the electrode pads which comply 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.
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5.2.1 Place electrodes on skin
Place the electrodes on the body parts in need of
treatment. Please ensure the skin is clean and dry before
use and ensure the skin and the electrode connects well,
see picture below.
You are now ready to commence your treatment.
Caution
Do not insert the electrode wires into any AC power
supply socket.
5.3 ELECTRODES
5.3.1 Electrode information
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
replacement electrodes. For replacement electrodes
please contact Body Clock Health Care:
108 George Lane, South Woodford, London, E18 1AD.
Telephone (+44) (0)2085329595. www.bodyclock.co.uk
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Caution
1. Before applying or removing electrodes ensure that
your device is switched off.
2. Hold electrodes at the edges.
3. Do not remove electrodes by pulling at the wires
attached to the the unit or the pads. This may cause
damage to both. Hold the electrodes and gently peel
them off your skin.
4. Do not turn on the device until the self-adhesive
electrodes are positioned on the body.
5. We recommend that electrodes no smaller than
50x50mm are used at the treatment area.
6. Never touch or remove the self-adhesive electrodes
from the skin while the device is still switched on.
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Neck
Shoulder
Arm
Hand
Back
Abdomen
Position of electrode placement
under TENS programs
5.4.3 Electrode Placement Chart
Suggested electrode placement charts for treating various
body areas can be seen below.
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Neck
Shoulder
Arm
Hand
Back
Abdomen
Hip
Leg
Foot
Joint (knee)
Joint (elbow)
Joint (ankle)
Joint (wrist
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Neck
Shoulder
Arm
Hand &
back
Abdomen
Hip & foot
Leg
Position of electrode placement
under EMS programs
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