Brilnurse FM-B2404 User manual

FM-B2404/PRO15AB
Nerve Muscle Stimulators
Pain Relief Anywhere and Anytime
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Table of contents
1. SAFETY INFORMATION
1.1 General Introduction
1.2 Medical Background
1.3 Intended for Use
1.4 Contraindications
1.5 Warnings, Cautions, and Adverse Reactions
1.6 Patient Population
1.7 Potential Electromagnetic and Other Interference
1.8 Explanation of figures, symbols, warning statements
and abbreviations on the device
2. DEVICE PRESENTATION
2.1 Illustration of the Device
2.2 Illustration of the Accessories
3 SPECIFICATION
4 INSTRUCTIONS FOR USE
5 CLEANING AND CARE
5.1 Tips for Skin Care
5.2 Cleaning the Device
5.3 Electrodes
5.4 Cleaning the Electrode’s Cords
5.5 Maintenance
6 TROUBLE SHOOTING
7 RECOMMEND USE POSITION
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1. SAFETY INFORMATION
1.1 General Introduction
Thank you very much for using our Nerve Muscle Stimulator. For
you use this device safely, please read this user manual
carefully before your first use.
Please keep this user manual with your device for future
reference.
This device is a portable electrotherapy device, featuring two
therapeutic modes: Transcutaneous Electrical Nerve Stimulator
(TENS) and Electrical Muscle Stimulation (EMS), which are
used for pain relief and electrical muscle stimulation. The
stimulator sends gentle electrical current to underlying nerves
and muscle group via electrodes applied on the skin. The
parameters of the device are controlled by the buttons on the
touch screen panel. The intensity level is adjustable according
to the needs of the individual user.
1.2 Medical Background
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation (TENS) is a
noninvasive, drug free method of controlling pain. TENS uses
tiny electrical impulses sent through the skin to nerves to modify
your pain perception. TENS does not work for everyone.
However, in most patients it is effective in reducing or eliminat-
ing the pain, allowing for a return to normal activity.
HOW TENS WORKS
The TENS unit sends comfortable impulses through the skin that
stimulate the nerve (or nerves) in the treatment area. In many
cases, this stimulation will greatly reduce or eliminate the pain
sensation the patient feels. Pain relief varies by individual
patient, mode selected for therapy, and the type of pain. In many
patients, the reduction or elimination of pain lasts longer
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EXPLANATION OF EMS
Electrical Muscle Stimulation (EMS) is an internationally
accepted and proven way of treating muscular injuries. It works
by sending electronic pulses to the muscle needing treatment;
this causes the muscle to exercise passively. This device has
low frequency and in conjunction with the square wave pattern
allows direct work on muscle groupings. This is widely used in
hospitals and sports clinics for the treatment of muscular injuries
and for the reeducation of paralyzed muscles, to prevent
atrophy in affected muscles and improving muscle tone and
blood circulation.
than the actual period of stimulation (sometimes as much as
three to four times longer). In others, pain is only modified while
stimulation actually occurs.
HOW EMS WORKS
The EMS units send comfortable impulses through the skin that
stimulate the nerves in the treatment area. When the muscle
receives this signal, it contracts as if the brain has sent the
signal itself. As the signal strength increases, the muscle flexes
as in physical exercise. When the pulse ceases, the muscle
relaxes and this cycle is repeated until therapy is completed.
The goal of electrical muscle stimulation is to achieve
contractions or vibrations in the muscles. Normal muscular
activity is controlled by the central and peripheral nervous
systems, which transmit electrical signals to the muscles. EMS
works similarly but uses an external source (the stimulator) with
electrodes attached to the skin for transmitting electrical
impulses into the body. The impulses stimulate the nerves to
send signals to a specifically targeted muscle, which reacts by
contracting, just as it does with normal muscular activity.
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1.3 Indication for use (IFU)
TENS:
The device is designed to be used for temporary relief of pain
associated with sore and aching muscles in the shoulder, waist,
back, neck, upper extremities (arm), lower extremities (leg),
abdomen and bottom due to strain from exercise or normal
household work activities.
1.4 Contraindications
1) This device should not be used for symptomatic local pain
relief unless etiology is established or unless a pain syndrome
has been diagnosed.
2) This device should not be used when cancerous lesions are
present in the treatment area.
3) Stimulation should not be applied over swollen, infected,
inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebi-
tis, varicose veins, etc.).
4) Electrodes must not be applied to sites that might cause
current/stimulation to flow through the carotid sinus region
(anterior neck) or trans-cerebrally (through the head).
5) Patients with an implanted electronic device, such as a
cardiac pacemaker, implanted defibrillator, or any other metallic
or electronic device should not use this device without first
consulting a doctor.
EMS:
The device is designed to be used to stimulate healthy muscles
in order to improve or facilitate muscle performance:
IMPORTANT SAFETY INFORMATION
Read instruction manual before operating. Be sure to comply
with all “Contraindications”, Warnings”, “Cautions” and “Adverse
reactions” in the manual. Failure to follow instructions may
cause harm to user or device.
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6) This device should not be used over poorly enervated areas.
7) This device should not be used on patients with serious
arterial circulatory problems in the lower limbs.
8) This device should not be used on patients with abdominal or
inguinal hernia.
9) Patients with heart disease, epilepsy, cancer or any other
health condition should not use this device without first
consulting a physician.
1.Apply stimulation only to normal, intact, clean, healthy skin.
2.Do not apply stimulation when in the bath or shower.
3.Do not apply stimulation while sleeping.
4.Do not use this device during pregnancy unless directed by
your physician.
5.Stimulation should not be applied over the neck, mouth or
eyes. Severe spasm of the laryngeal and pharyngeal muscles
may occur, and the contractions may be strong enough to close
the airway or cause difficulty in breathing.
6.Stimulation should not be applied across the chest in that the
introduction of electrical current into the heart may cause
cardiac arrhythmias.
7.Stimulation should not be applied across the head.
8.Stimulation should not be applied over the carotid sinus nerve,
particularly in patients with a known sensitivity to the carotid
sinus reflex.
9.Replacement of a component could result in an unacceptable
risk. Please contact us if you have any problem with the device.
10.Keep this device out of the reach of infants, toddlers, and
children.
1.5 Warnings, Cautions, and Adverse Reactions
Warnings
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11.Do not recharge, use or leave the battery and device in any
high temperature environment such as a location near fire or in
direct sunlight. Doing so may cause the battery to overheat,
ignite or rupture.
12.There is potential hazard from simultaneous connection of a
patient to a high frequency surgical equipment and the
stimulator that may result in burns and possible damage to the
stimulator.
13.Operation in proximity (e.g. 1 m) to a shortwave or
microwave therapy equipment may produce instability in the
stimulator output.
14.When the device is transferred to another patient,replace
used pads with new pads.
15.Please avoid the use of the equipment as much as possible
in the following occasions or conditions, as it may result in
incorrect operation: talking on a mobile phone; near the signal
emission base station for broadcasting, television, communica-
tion, radar, navigation, etc.; near active HF SURGICAL
EQUIPMENT and the RF shielded room of an ME SYSTEM for
magnetic resonance imaging.
16.Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of the equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
17.Portable RF communications equipment (including peripher-
als such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the
equipment including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
18.The device delivers a current density 0.612 mA/cm2, In order
to mitigate potential adverse events:
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Cautions
1. This device is for single patient use only.
2. Keep yourself informed of the contraindications.
3. This device is not intended for use on an unattended patient
who is noncompliant, emotionally disturbed, has dementia, or a
low IQ.
4. This device should not be used while driving, operating
machinery, close to water or during any activity in which
involuntary muscle contractions may put the user at undue risk
for injury.
5. Never use the device in rooms where aerosols (sprays) are
used or pure oxygen is being administered.
6. Do not use this device at the same time as other equipment
which sends electrical pulses to your body.
7. Do not confuse the electrode cables and contacts with your
headphones or other devices, and do not connect the electrodes
to other devices.
8. Do not use sharp objects such as pencil point or ballpoint pen
to operate the buttons on the control panel.
9. Inspect applicator cables and associated connectors before
each use.
10. Turn the device off before applying or removing the
electrodes.
1)Please do not turn on the device before connecting the wires,
electrode pads, device and body.
2)The electrode pads have been pasted to the appropriate part,
and the mainframe and wire have been properly connected
before it can be turned on.
3)During normal use, do not touch the hydrogel on the electrode
pads, do not pull out the wire plug, do not pull out the electrode
pads. All these actions must be performed after shutting down.
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Adverse Reactions
1. Potential allergic reactions due to the electrical stimulation or
gel including skin irritation, redness, burning or hypersensitivity.
If skin irritation occurs, discontinue use and consult your
physician.
2. Discomfort occurs due to improper stimulation levels, reduce
the stimulation intensity or turn the device off directly.
3. Headache and other painful sensations during or following the
application of electrical stimulation near your eyes, to your head
and face.
*** You should stop using the device and consult with your
physician if you experience any adverse reactions from the
device. ***
Notes
1. Please note that the original recognized accessories,
detachable parts and material which are approved by standard.
2. Please note that the adapter you choose for battery charging
must complies with ANSI/AAMI/ES60601-1 or IEC 60950
standards.
11. Electrical stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
12. Do not use it in the presence of explosive atmosphere or
flammable mixture.
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1.6 Patient Population
1.7 Potential Electromagnetic and Other Interference
The “Patient” is an intended user.
Adults who suffer from sore and aching muscles in the shoulder,
waist, back, neck, upper extremities (arms), and lower extremities
(leg) due to strain from exercise or normal household work
activities can use this Device.
However, it should not be used by children, pregnant women, or
anyone who has an implanted metallic or electronic device. Ask
your physician if you have any questions related to your health.
Notes
1. This part is about the safety information. It is intended to help
you use it safely, prevent injury and avoid situation which could
result in damage on the device. It is important for you to read this
information carefully.
2. Please note that the original recognized accessories,
detachable parts and material which are approved by standard.
3. Please note that the adapter you choose for battery charging
must complies with ANSI/AAMI/ES60601-1 or IEC 60950
standards.
This product is sensitive to the electromagnetic interference, and
the following cases may interfere with normal use:
● When talking on the mobile phone.
● Near the base station for signal transmission (broadcast,
television, communications, radar, navigation, etc.).
● Near high radiation medical instruments such as nuclear
magnetic resonance.
The operator should be away from the equipment or occasion as
soon as possible if the essential performance of the equipment is
degraded or lost due to EM DISTRUBANCES. The essential
performance of the equipment should be restored. If not, please
contact your local dealer.
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1.8 Explanation of figures, symbols, warning statements
and abbreviations on the device
Caution!
Meanings of symbols used for marking described in
instructions for use
Type BF applied part
Direct current
Refer to instruction manual
Serial Number
Manufacture date
Manufacture information
Authorized representative in the European Community
WEEE Label
Protected against solid foreign objects of 12,5 mm Ø
and greater; Protection against vertically falling water
drops when ENCLOSURE tilted up to 15°
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2. DEVICE PRESENTATION
2.1 Illustration of the Device
ON/Off Switch: When the switch is turned to the "ON" position,
the device is turned on, and when it is turned to the "Off"
position, the device is turned off.
USB Port: AC adapter connecting port, when used for charging,
the interface between the charging cable and the device.
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Battery indicator
On/Off switch
LCD
AB
USB port
Time indicator
Mode indicator
Output A Output B
Mode select
B Intensity adjustment(+)
Mode adjustment
B Intensity adjustment(-)
AIntensity adjustment(+)
AIntensity adjustment(-)
A/B / Pause
Time adjustment
A/B Intensity indicator
Mode select

Battery Indicator: Used for battery level display. When the
battery is about to run out, a flashing battery symbol will appear
on the display. It should be charged as soon as possible.
However, depending on the settings and intensity level, the
machine may continue to operate for a longer period of time.
Time Indicator: Display the remaining working time after being
ON(Min).
Mode Indicator: There are 24 modes in total, in the middle area
of the display, touch the mode adjustment button, the control
area corresponding to the mode will flash. Then press the mode
select button to select the mode.
There are 12 TENS modes:
There are 12 EMS modes:
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Simulation of Tuina is a
hands-on body treatment
which help with pain relief and
relaxation
Stimulate pain points in the
hand area for pain relief or
muscle relaxation.
It is a type of alternative
medicine consisting of finger
and palm pressure, stretches,
and other massage
techniques.
Stimulate pain points in the
lumbar area for pain relief or
muscle relaxation.
Stimulating tapping is intended
to produce a hard thumping
sensation that massages your
muscles, which can give you
an invigorated and revitalized
feeling.
Random combination of basic
modes. Full body relaxation
after workout, exercises &
fitness after a hard day
working.
Tuina
Hand
Kneading
Back
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2Blend
Tapping
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Stimulate pain points in the
hip, sciatica nerve for pain
relief or muscle relaxation.
Stimulate pain points in the
Foot area for pain relief or
muscle relaxation.
Simulation of acupuncture
provides the same sensation
without needles, by utilizing
electronic pulses to achieve
the sensation of differing
needle depths.
Combination of acupuncture. It
helps lose weight or tone,
strengthen and firm muscles
at abs, back,thighs and arms
etc.
It is the manipulation of
superficial and deeper layers
of muscle and connective
tissue using various
techniques.
Stimulate pain points in the
knee area for pain relief and
muscle relaxation.
Stimulate pain points in the
elbow area for pain relief or
muscle relaxation.
Hip
Foot
Acupunc-
ture
Weight
Loss
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Knee
Pressure
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Stimulate pain points in the
lumbar area for pain relief or
muscle relaxation.
Shiatsu is simulation of a type
of finger and palm pressure,
stretches, and other massage
techniques.
Stimulating with a low
frequency setting provides the
user with a scratching and
kneading sensation.
Mimic the sensation of suction
created on the skin. Cupping
is a traditional Chinese
therapy in which heated glass
cups are applied to the skin,
creating suction as a way of
stimulating the flow of energy.
Mimic the sensation of suction
created on the skin. Cupping
is a traditional Chinese
therapy in which heated glass
cups are applied to the skin,
creating suction as a way of
stimulating the flow of energy.
Stimulate pain points in the
elbow area for pain relief or
muscle relaxation.
Hip
Foot
Acupunc-
ture
Cupping
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4
1
2
3Elbow
Shoulder
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M Select Button: Mode select button, When the type of mode is
determined (Mode Adjustment), you can select the specific
mode by pressing the M button.
< and > Button: Mode adjustment button, used to select the
type of mode(6 types, please to see the mode indicator).
Intensity Indicator: A and B, A only shows the intensity of A
channel, B only shows the intensity of B channel. When you
repeatedly click the A/B button at the bottom of the device, A or
B Intensity Indicator will switch and flash.
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Stimulate pain points
specifically in the ankle for
pain relief or muscle
relaxation.
Random combination of basic
modes
Deep tissue massage therapy
is similar to Swedish
massage, but the keeper
pressure is beneficial in
releasing chronic muscle
tension.
It helps muscle reduction,
relaxation of muscle spasms,
increase range of motion,
injury recovery post surgery
recovery.
Stimulate pain points in the
body area for pain relief or
muscle relaxation.
Ankle
Combina-
tion
Deep
Tissue
Massage
Fibrillation
massage
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2.2 Illustration of the Accessories
Features of the Device
Important Information
+ / - Button: Intensity adjustment button, Select the A channel or
the B channel by the A/B button, to touch once + button, the
strength will increase by one, and touch once – button, the
strength will decrease by one.
A/B Button: A/B channel switch button, the default is channel A
when power on, click the A/B button once to switch to channel B,
click repeatedly to switch repeatedly.
Pause Button: Used to pause the device during use.
T Button: Used to adjust the device working time, the default
time is 30 minutes. User are able to adjust the time from 10
minutes to 90 minutes by the T button. The timer could be
increased by 10 minutes intervals.
A and B: Output A and Output B, are output socket, electrical
signal output after connection of the cable with adhesive
electrodes channel A or channel B.
● LCD display
● 2 independent channels
● Adjustable timer up to 90 minutes
● 24 different operating modes
● Rechargeable internal polymer bazttery
● 30 level intensity settings
● Allows 2- 4 pads to be applied to the different targeted areas
at the same time
● 2 outputs are isolated, so both channel A and channel B has
the same 100% power
● Applied part: self-adhesive electrode pads
Degraded sensors and electrodes, or loosened electrodes, can
degrade performance or cause other unsafe issues.
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3. SPECIFICATION
Power
4. INSTRUCTIONS FOR USE
How to Use the Device
Included in this package
● Tens Device × 1pc
● Oval pads × 2 pcs
● Palm pads × 6 pcs
● Rectangular pads × 2 pcs
● Electric wire × 2 pcs
● USB cable × 1 pc
● Instruction manual × 1pc
● lanyard × 1pc
● Storage Bag × 1pc
Input voltage: DC5V
Rated current: ≤ 50mA
Rated power: ≤ 0.25W
Li-ion battery:3.7 V dc
1.Environmental operating conditions: Temperature: -5 ~ +40°C
Humidity: Does not exceed 85% Atmospheric pressure range of
800 hPa to 1 060 hPa
2.Please make sure the device is on the OFF position when
setting up the unit, adjusting the pads, or making a new
connection.
3.Do not turn on the device before you place pads on your skin.
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This manual suits for next models
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