Manual Tens - PDFA

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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 ¡s a portable electrotherapy device, featuring three therapeutic
modes: Transcutaneous Electrical Nerve Stimulator (TENS), Electrical
Muscle Stimulation (EMS) and Massage, which are used for pain relief and
electrical muscle stimulation. The stimulator sends gentle electrical current
to underlying nerves and muscle group vía electrodos 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 eliminating the pain, allowing for a retum 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 elimínate the pain sensation the patient feels. Pain
relief varíes by individual patient, mode selected for therapy, and the type
of pain. In many patients, the reduction or elimination of pain lasts longer
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.

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EXPLANATION OF EMS
Electrical Muscle Stimulation (EMS) is an intemationally 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 pattem 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.

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
contraéis 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 then 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 signáis
to the muscles. EMS works similariy but uses an extemal source (the
stimulator) with electrodos attached to the skin for transmitting electrical
impulses into the body. The impulses stimulate the nerves to send signáis
to a specifically targeted muscle, which reacts by contracting, just as it
does with normal muscular activity.

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.

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EMS:
The device ¡s designed to be used to stimulate healthy muscles In order to
improve or facilítate 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.

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, thrombophlebitis, vaneóse veins, etc.).
4) Electrodos must not be applied to sites that might cause current/stimu-
lation to flow through the carotid sinus región (anterior neck) or trans-cere-
brally (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.
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, cáncer or any other health
condition should not use this device without first Consulting a physician.

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1.5 Warnings, Cautions, and Adverse Reactions
Warnings
1. Apply stimulation only to normal, intact, olean, 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 cióse 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, particulariy
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.
11. Do not recharge, use or leave the battery and device in any high
temperatura environment such as a location near fice or in direct sunlight.
Doing so may cause the battery to overheat, ignite or ruptura.
12. There is potential hazard from simultaneous connection of a patient to a
high frequency surgical equipment and the stimulator that may result in bums
and possible damage to the stimulator.
13. Operat¡on 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, televisión, communication, 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 manufacturar of the equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

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17. Portable RF Communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part oí the equipment including cables specified by the
manufacturen Otherwise, degradation of the performance of this equipment
could result.
18. The device delivers a current density, in order to mitígate potential
adverse events:
1) Please Do not tum on the device before connecting the wires, electrodo
pads, device and body.
2) The electrodo pads have been pasted to the appropriate part,and the
mainframe and wire have been properiy connected before it can be tumed
on.
3) During normal use,do not touch the hydrogel on the electrodo pads,do not
pulí out the wire plug, do not pulí out the electrodo pads. AH these actions
must be performed after shutting down.

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, cióse
to water or during any activity in which involuntary mustíe contractions may
put the user at undue risk for injury.
5. Never use the device in rooms where aerosols (sprays) are used or pura
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 electrodo cables and contacts with your headphones
or other devices, and do not connect the electrodos to other devices.
8. Do not use sharp objects such as pencil point or ballpoint pen to opérate
the buttons on the control panel.
9. Inspect applicator cables and associated connectors before each use.
10. Tum the device off before applying or removing the electrodos.
11. Electrical stimulators should be used only with the leads and electrodos
recommended for use by the manufacturar.
12. Do not use it in the presence of explosivo atmosphere or flammable
mixture.

OS
Adverse Reactions
1. Potential allergic reactions due to the electrical stimulation or gel
including skin irritation, redness, buming or hypersensitivity. If skin
irritation occurs, discontinué use and consult your physician.
2. Discomfort occurs due to improper stimulation levels, reduce the
stimulation intensity or tum 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
compiles with ANSI/AAMI/ES60601-1 or IEC 60950 standards.

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2. DEVICE PRESENTATION
2.1 lllustration of the Device

1. CH1/CH2 output connector 9. Belt dip


2. Charging port 10. CH1 intensity adjustment
3. LCD screen CH2 intensity adjustment
4. Press P: built-in mode selector II. Lead wire
5. Set data ¡n DIY mode 12. Electrode pads
6. Time adjustment
7. On/offbutton;unlockbutton
8. Press M: 4 main modes
(TENS/EMS/MASS/DIY)

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2.2 lllustration of the Accessories

Features of the Device


• LCD display
• Ch1/ch2dualoutput
• Adjustable timer up to 90 minutes
• 25 mode TENS, EMS, MASS.DIY
• Rechargeable intemal Li-on battery
• 40 level intensity settings
• Allows 2- 4 pads to be applied to the different targeted areas at the same
time
• Applied part: self-adhesive electrodo pads

Important Information
Degraded sensors and electrodos, or loosened electrodos, can degrade
performance or cause other unsafe issues.

Included in this package

• Tens Device x 1 pe
• 2"*2" Tens pads x 4 pes
• USB cable x 1 pe
• Lead wire x 2 pes
• HardTravelCasex 1 pe
• Instruction manual x 1 pe

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3 DUAL POWER SOURCES
Rechargeable Battery
Input voltage: DC5V
Rated current: s 50mA
Rated power: s 0.25W
LMon battery: 3.7 VDC

4 INSTRUCTIONS FOR USE


How to Use the Device

I.Environmental operating conditions: Temperatura: -5-+40C Humldity:


Does not exceed 85% Atmospheric pressure range of 800 hPa to 1060
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. Place pads on your skin before turning on the device. Use at least one
pair of pads, one pad alone will not work.

Before using the device, please check following carefully:

1 .Check the electrode wires for any damages or irregularities.


2 .Check the electrode pads for any damages or irregularities.
3 .Check for any physical damage on the unit.

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Step 1: Connect the electrode wire to the device

The KRES1010 equipped with two isolatedchannels CH1 &CH2 (only isolated
in intensities). This will allow you to set same modes but sepárate ¡ntensities
on each channel using the 2 outputs CH1 CH2. Before connecting the wires
to the unit, decide which channel you wish to use (channel CH1 or CH2). To
use CH1 channel only, connect the electrode wire(s) to outputs CH1. To use
CH2 channel only, connect the electrode wire(s) to outputs CH2. To use both
CH1, CH2 channels, connect the electrode wires to all outputs.

1. Plug the electrode wire into the output located at the head of the device.
2. Ensure that the electrode wires are fully inserted into the output and
secured. Make sure the wires are not loose. A loose connection will lower the
power output of your device, potentially causing unreliable connection.
Repeat 1 &2 to connect another wire.

CAUTION:
Do not insert the plug of the patient lead wire into any AC power supply
socket.

Step 2: Connect the electrode pads to the wires


I .Each wire has two leads with button-in connectors. Insert the wire
connectors into the pads. Make sure that at least one pair (2 pieces) of
pads is attached to the same wire. One pad alone will not work.
2 .Make sure at least one pair of pads is attached to the same wire.
3 .Check the connections to ensure they are fastened

CAUTION:
I.PIease make sure the device is on the OFF status when setting up theunit,
adjusting the pads, or making a new connection.

2 .DO NOT tum on the unit before you put pads on your skin.
Use at least one pair of pads. One pad alone will not work.

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Step 3: Place electrodes on skin
1. Remove the plástic films on the pads.
2. Check if the adhesive side of on the pad is clean after removing the
plástic film.
3. Place pads on the muscle you wish to treat. Make sure your skin has
been cleaned of all dirt, oil, or lotions.
4. Be sure to place the adhesive side of pad on your skin.
5. We recommend keeping the plástic films for storing the pads after
usage.
6. Make sure that you use at least one pair of pads on the same wire at the
same time ,one pad alone wlll not work.
7. Make sure the pads are stick adhered closely on your skin.

CAUTION:
1. Do not overiap pads or place one pad on top of another one.
2. Never remove the self-adhesive electrodes from the skin while the
device is tumed on. You will feel an uncomfortable electrical shock.

Electrodo Placement
The placement of electrodes can be one of the most important parameters
in achieving success with this therapy. Of utmost importance is the
willingness of the physician to try the various styles of electrodo placement
to find which method best fits the needs of the individual patient.
Once an acceptable location has been achieved, mark down the electrodo
sites and the device settings, so the patient can easily continué treatment
on them.

Step 4: Turn on the device


Long Press the ON/OFF switch button «TiQ to start the device.
Verify the channel indicator on the screen to make sure the device is on
the same channel you wish to use.

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CAUTION:
Before using the device for the first time, you are strongly advised to take
careful note of the contraindications and safety measures detailed at the
beginning of this manual (Safety information).

Step 5: Select mode or program number


There are 4 mode selectora (TENS, EMS, MASS & DIY). In TENS, EMS, MASS
mode, and then press the P key to select the pulse rate, there are 8 settings
pulse rates, from P01 to P08. In addition, in DIY mode, the default is P01 on
the screen, and press the button DIY + and DIY - to adjust the output
frequency must be in the DIY mode. (Pulse rate range: 2-150 rate HZ setting)

Press the mode selector button M to select the mode,the selected ¡con will
flash and press P button to select program number.

© 88“* ® " Sü)


TENS EMS MASS DIY
Adjust the output frequency
P88 |888-." Press D*, ¿ button to Adjust
the output frequency,must be
in the DIY mode.

CAUTION:
1. Intensity level defaults to zero when starting unit or when changing
modes for your safety.
2.Refer to Mode Indicator illustration of the device to confirm what kinds of
mode you choose, TENS ,EMS or MASS.

Step 6: Select intensity


There are 40 intensity Settings. Adjust Channel Intensity for channel CH1,
use output(s)CH1:
1 .CH1 and CH2 are two independent control channels. CH1 is the output
intensity control for CH1 channel, and CH2 is the output Intensity control for
CH2 channel.

2 .Confirm channel CH1 is working, revolve left coder to increase/decrease the


intensity. When changing the mode, the intensity level will automatically reset
zero.

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3 .Confirm channel CH2 is working, revolve right coder to increase/decrease
the intensity.When changing the mode, the intensity level will automatically
reset zero.

CAUTION:
1. We recommend starting at the lowest level of intensity and gradually
increase to a level that is comfortable
2. The intensity should be set at a level where you will experience somed
muscular vibration and involuntary muscle movements.
3. If the stimulation levels become uncomfortable, reduce the stimulation
intensity to a comfortable level or turn it off directly.

Step 7: Adjust timer


The timer will increase in the increment of 10. Adjust timer from 10 minutes
up to 90. Keep pressing the timer button 0 to set to 90 minutes. The default
timer is 30MIN.

Step 8: Deblocking
After the device starts to work, it will automatically lock if no operation within
30s, and a lock icón £ will appear on the screen accordingly. Press the button
to unlock the keyboard.

Step 9: Turn off the device


Long Press the iTlO switch button to off the device.

SteplO: Remove the pads from your skin


Lift the comer of the electrode and gently remove it from the skin, and place
them back on the provided pad holder or the protective plástic film.

CAUTION
DO NOT remove the pads before you turn off the equipment.

Step 11: Take off the pads from wires.Unplug wires from device.
Maintain the device in accordance with maintenance requirements.

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5 CLEANING AND CARE
5.1 Tips for Skin Care
Follow these suggestions to avoid skin irritation, especially if you have
sensitiva skin:
1. Wash the area of skin you will be placing the electrodos on with soap.
Rinse thoroughly and dry the area completely before and after placing
electrodos.
2. Excess hair may be clipped with scissors; do not shave stimulation area.
3. Many skin problems arise from the “pulling stress" from adhesive patches
that are excessively stretched across the skin during application. To prevent
this, apply electrodos from center outward; avoid stretching over the skin.
4. To minimíze "pulling stress", tape extra lengths of lead wires to the skin in
a loop to prevent tugging on electrodos.
5. When removing electrodos, always remove by pulling in the direction of
hair growth.
6. It may be helpful to rub skin lotion on electrode placement area during
treatment down time when you are not wearing electrodes.
7. Never apply electrodes over irritated or broken skin.

5.2 Cleaning the Device


1. Remove the battery from the device before you clean the device.
2. Clean the device after use with a soft, slightly moistened cloth.
3. Do not use any Chemical cleaners or abrasive agents for cleaning.

5.3 Electrodes
1. Use this device only with the leads and electrodes provided by the
manufacturar.
2. Inspect your electrodes before every use. Replace electrodes as needed.
Reusable electrodes can cause slight skin irritation, lose adhesión
properties and deliver less stimulation if overused.
3. The ordering Information of the electrodes pads: Available for purchasing
on Amazon, or other e-commerce platforms. But it specifies the manufactur-
er of the electrode pads, the manufacturar is the best choice for you. Be free
to contad the seller if you need.
4. The electrode type: It is a kind of hydrogel and medical silicone.

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Warning:
1. The electrode size, shape, and type may affect the safety and
effectiveness of treatment and that a risk associated with use of the wrong
size electrode is thermal bum.
2. We advises you to obtain replacement electrodes that are the same type,
have the same dimensions and same connectors as those you distribute with
your device.

TO REMOVE YOUR ELECTRODES:


1. Lift the comer of the electrode and gently remove it from the skin.
2. It may be helpful to improve repeated electrode application by spreading a
few drops of coid water over the adhesive side and tum the surface up to air
dry. Over saturation with water will reduce the adhesive properties.
3. Between uses, place the electrodes back onto the protective sleeve and
inserí them into the re-sealable bag and store In a cool dry place.

CAUTION:
1. Do not pulí on the electrode wire. Doing so may damage the wire and
electrode.
2. The electrodes should be discarded when they are no longer adhering to
the skin.

5.4 Cleaning the Electrode’s Cords


Clean the electrode cords by wiping them with a damp doth.
Coating then lightly with talcum powder will reduce tangles and prolong their
life.

5.5 Maintenance
1. Maintenance and all repairs should only be carried out by an authorized
agency. The manufacturar will not be held responsible for the results of
maintenance or repairs by unauthorized persons.
2. The user must not attempt any repairs to the device or accessories.
Please contad the seller if you have any problems.
3. Opening of the equipment by unauthorized agencies is not allowed and
will termínate any claim to warranty.
4. Check the unit before each use for signs of wear and/or damage. Replace
wom ítems as required.

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5. Please clean the main machine frequently. Use a piece of soft dry cloth to
wipe the dirt on the main machine. Don't wash with water or clean with the
detergent, thinner, volatile oil, etc. that contains Chemical substances.
6. The gel surface of the massage pad should be kept clean and avoid dirt
like dust, oily substances, sticky substances, etc., otherwise the stickiness
will be decreased.
7. Please put the massage pads back to the pad holders or paste the
protective films back onto the pads after use.
8. When the stickiness of the massage pad becomes weak due to dirt or if
there is a tingling sensation in the skin, please use a piece of damp cloth
dipped in a little water to gently wipe the gel surface. After drying, the
stickiness will recover, but if water is overused, the stickiness will be
decreased.
9. Please dont wipe the gel surface with a paper towel.
10. Please Do not scrape the gel surface with nail, brush, etc.
11. Massage pads are consumables with the Service Ufe of generally 20-30
times. If the pads are not sticky or the stimulator becomes weak, please
change the pads in time.
12. The batteries for this product are built-in polymer batteries. If it is not used
for a long time, please charge it every 6 months.

Safekeeping
1 .Please do not put the main machine in the place exposed to sunlight, high
temperatura, humidity, lots of dust, or the place cióse to fire, easy to víbrate
or shock.
2 .Please put where children can't reach it.

Cleaning and Storage


Environmental conditions of transport and storage:
Temperatura: -20 ~ +60 C,
Humidity: Humidity does not exceed 85%
Use a lightly moistened cloth to clean the device and wipe gently.
• Make sure the device is off when you clean it.
• Do not let water to get into the device.

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Cleaning and Storing Pad
Clean: After using pads on your body, please drop a little olean water on
the sticky side and use fingertips to clean it softly
• Please tum off the device and disconnect the pads with wires first
before you clean the pad.
• Do not use nails or other Sharp objects on the sticky side.
• Do not use Chemical liquids on sticky side.
Storage: Place pads on pad holder or place plástic film on the sticky side
of pad to keep the gel moisture.
Wires: You can wrap wires on pad holder.

DISPOSAL
Please dispose of the device in accordance with the laws in your area.
6 TROUBLE SHOOTING
If your device does not seem to be operating correctly, refer to the chart
below to determine what may be wrong. Should none of these measures
correct the problem, the device should be serviced.

PROBLHM CAUSE SOLUTION


One pad feels stronger This Is normal Difieren 1 Nothing needs lo be done Make sute the
ttian the dhv. ateas ofyour body wlll pads ate moist and are making good
read dlfferenlly contad
Adheslve gel pads are Apply a few ckops of water to adheslve
Ourtng the massage, the
not adherlng firmly to the surface of each pad and make sute the
skin feels a pakiftl bumlng
skin pads are press ed lirrrty lo the skin duiing
sensabon or the simulatlon
The gel pads are too dty appUcation
b ecomes weakened
wires ate damaged Use anewsetofpads.

Both pacto are not firmly Make sute both pads are firmly pressed to
on the skin the skin. (two pads mínimum) One pad
unit is on. bul no There is a loase alone will not work
sensation Is felt in the connecSon. Make sute all comedions are se cure
pads The mtensity leve! needs from the un i to the wses and Ihe wires to
to be lacrea sed the pads

Adhesiva gel pads Do not


stfc* to skin even altor Adheslve material ran out. Adheslve gel pads need to be replaced
deanlng and molstening

Unit does not tum on or Battery is low iecharge Ihe battery


___ the aereen is dm_____
Uní does not charge Mil adaptar or USB cord Charge your unit using USB cord only uslng
sny USB powor outlet
• Your device features • Try to setthe modo and/orthe intensity
Only feel stimulation one
the AB Independen! on each chame l
ctiannel
chamel • Try to use a new set of wires

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RECOMMEND USE POSITION

Arm Elbow
OHip

Waistl Waist2 Abdomen

MO O
Thlgh Calf/Foot Hand Jolnt

©' l w
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Medical Disclaimer

AH Information is intended for you general knowledge only and is not a


substituto for medical advice or treatment for specific medical conditions. The
Information contained here is intended to provide broad consumer
understanding and knowledge of product offered.
The Information should not be considerad complete and should not be used
in place of a visit, cali, consultation or advice or your health cara provider.

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