Carex AccuRelief ACRL-9000 User Manual
Clinically
Proven
This manual is valid for the AccuRelief™ Wireless TENS Pain Reliever ACRL-9000.
This instruction manual is published by Carex Health Brands.
Carex Health Brands reserves the right to improve and amend this manual at any time without prior notice.
Amendments may however be published in new editions of this manual.
All Rights Reserved. Rev. V2.0 © 2014, 20140513
Conformity to safety standards
Carex Health Brands declares that the device complies with the following normative documents:
IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC62366, IEC60601-1-11
ISO10993-5, ISO10993-10, ISO10993-1, ISO7010
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TABLE OF CONTENTS
Introduction .............................................................................................................................. 4
Important safety precautions and warnings ............................................................................... 6
Package contents ................................................................................................................... 13
Product structure .................................................................................................................... 14
Know your device ................................................................................................................... 15
Battery information ................................................................................................................. 16
Treatment information ............................................................................................................. 17
Gel pad positioning ................................................................................................................ 18
Maintenance and cautions ..................................................................................................... 21
Storage................................................................................................................................... 21
Technical specifications ........................................................................................................... 22
Program ................................................................................................................................. 23
Disposal.................................................................................................................................. 23
Troubleshooting ...................................................................................................................... 24
Important information regarding electromagnetic compatibility (EMC) ....................................... 25
Explanation of symbols ........................................................................................................... 32
Warranty ................................................................................................................................. 33
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not work for everyone. However, in most patients,
it is effective in reducing or eliminating the pain,
allowing for a return to normal activity.
How does TENS work?
Scientific theory suggests that electrical stimulation
therapy may work in several ways:
n The gentle electrical pulses move through
the skin to nerves nearby the source of pain,
shutting out the pain message from ever
reaching the brain.
n The gentle electrical pulses increase the
production of endorphins, the body’s natural
pain killer.
What conditions can TENS help relieve?
TENS provides pain relief for a number of different
pain conditions associated with exercise, normal
INTRODUCTION
Thank you for purchasing the AccuRelief™
Wireless TENS with Remote (Model ACRL-9000)
for your pain relief solution.
Please read the complete manual carefully before
using the device for the first time, and keep this
instruction manual in a convenient place or store
with the device for future reference.
The pain reliever ACRL-9000 is a TENS stimulator.
What is TENS?
TENS stands for Transcutaneous Electrical Nerve
Stimulation. It is a noninvasive, drug-free method of
controlling pain. TENS uses tiny electrical impulses
sent through the skin to the nerves to modify pain
perception. TENS does not cure any physiological
problem. It only helps control the pain. TENS does
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work and household activities. This product is
designed for temporary relief of muscle and joint
pain in the:
n Neck n Waist
n Shoulder n Upper Extremities (arms)
n Back n Lower Extremities (leg)
The pain reliever should be applied to
normal, healthy, clean and dry skin of
adult patients.
What can I treat?
The Pain Reliever can treat many different types of
pain. Refer to diagrams on page 20 for the ideal
locations to place the gel pads for the treatment of
the most common forms of pain. For other areas
of pain, place the gel pads on either side of the
pain area.
PLEASE NOTE: Never place the gel pads on the
head, face, heart, chest area, eyes, oral cavity,
carotid arteries, sexual organs or over the spine
or bony premises.
How long can I use the Wireless TENS unit?
You may use the Wireless TENS unit for at least 30
minutes a day. However, initially, you may need to
wear it for longer. Please seek medical advice. If
you wear it for longer periods, please check your
skin where the gel pads have been placed to ensure
your skin does not become sore.
PLEASE NOTE: The gel pads are designed for
temporary use for approximately 10 days when
used for 30 minutes a day.
The Wireless TENS ACRL-9000 contains the
following components:
n 6 x AAA battery n 2 x Gel pads with
n 1 x Remote control snap connector
n Quick start guide n 1 x User manual
n Draw-string carry bag n Gel pad units (A & B)
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SAFETY SYMBOLS USED IN THIS MANUAL
Indicates a potentially hazardous situation
which, if not avoided, could result in death
or serious injury.
Indicates a potentially hazardous situation
which, if not avoided, could result in
serious injury and equipment damage.
Indicates a potentially hazardous situation
which, if not avoided, may result in minor
or moderate injury to the user, or damage
to the device or other property.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
It is important that you read all the warning and precautions included in this manual because they
are intended to keep you safe, prevent injury and avoid a situation that could result in damage to
the device.
DANGER
This stimulator must not be used in
combination with the following medical
devices:
n Internally transplanted electronic medical
devices, such as pacemakers.
n Electronic life-support equipment, such as
respirators.
n Electronic medical devices attached to the body,
such as electrocardiographs.
Using this stimulator with other electronic medical
devices may cause erroneous operation of those
devices.
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WARNING
Consult with your physician before using
this device, because the device may
cause lethal rhythm disturbances in certain
susceptible individuals.
DO NOT USE THIS DEVICE UNDER
THESE CONDITIONS:
n If you have a cardiac pacemaker, active
implanted defibrillator, or other implanted
metallic or electronic device. Such use
could cause electric shock, burns, electrical
interference, or death.
n Together with a life-supporting medical
electronic device such as an artificial heart, lung
or respirator.
n 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.
n On open wounds or rashes, over swollen, red,
infected, inflamed areas, or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins); or
on top of, or in proximity to, cancerous lesions.
n Over areas of skin that lack normal sensation.
n On the opposite sides of your head since the
effects of stimulation of the brain are unknown.
DO NOT USE ON THESE INDIVIDUALS:
n Pregnant women, because the safety of
electrical stimulation during pregnancy has not
been established.
n Children or infants, because the device has not
been evaluated for pediatric use.
n Persons incapable of expressing their thoughts
or intentions.
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DO NOT USE THIS DEVICE DURING
THESE ACTIVITIES:
n Bathing or showering;
n Sleeping;
n Driving, operating machinery or any activity in
which electrical stimulation can put you at risk
for injury.
PAIN MANAGEMENT WARNINGS
n If you have had medical or physical treatment
for your pain, consult with your physician before
using this device.
n If your pain does not improve, becomes
seriously chronic or severe, or continues for
more than five days, stop using the device and
consult with your physician.
n The mere existence of pain functions as a very
important warning telling us that something
is wrong. Therefore, if you suffer from any
serious illness, consult your physician in order
to confirm that it is advisable for you to use this
TENS unit.
WARNINGS AND PRECAUTIONS
REGARDING THE PADS
n Apply pads to normal, healthy, clean, dry skin
(of adult patients) because it may otherwise
disrupt the healing process.
n If you experience any skin irritation or redness
after a session, do not continue stimulation in
that area of the skin.
NEVER APPLY THE PADS TO:
n The head or any area of the face.
n Any area of the throat because this can cause
severe muscle spasms resulting in closure
of the airway, difficulty breathing, or adverse
effects on heart rhythm or blood pressure.
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n Both sides of the thorax simultaneously (lateral
or front and back), or across your chest
because the introduction of electrical current
may cause rhythm disturbances, which could
be lethal.
CAUTION
WARNINGS AND PRECAUTIONS
REGARDING THE PADS
n Do not bend or fold because the pad may
not function properly. Place the pads onto the
plastic film and then store in the sealed package
when not in use.
n Do not apply ointment or any solvent to the
pads or to your skin because it will keep the
pads from functioning properly.
n The pads are already pre-gelled and will adhere
to your skin.
n To avoid damage to the adhesive surface of the
pads, put the pads only on the skin or on the
plastic film provided.
n Place the pads at least 2 inches apart on your
skin. The pads should never touch each other.
n Always place clean pads in accordance with
the illustrations provided (Refer to page 20 for
electrode placement).
n Make sure the components are connected well
and the pads are fixed on the part of the body
you wish to treat or the therapy may not be
effective.
DO NOT USE YOUR PADS THIS WAY:
n Pads should not touch each other
when placed onto your skin.
n Do not place on your spine or backbone.
n Pad should not touch any metal object, such as
a belt buckle, necklace or other jewelry made
from metal.
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n Pads should not be placed simultaneously on
the soles of both feet.
n Pads should not be placed simultaneously on
the calves of both legs.
n Do not share pads with another person. This
may cause a skin irritation or infection. Pads are
intended for use by one person.
n Do not place or relocate the pads while the
device is on.
n Always turn the power off before removing or
changing the pad location.
n Do not leave pads attached to the skin after
treatment.
CAUTION WHILE USING THE TENS UNIT
n If the TENS unit is not functioning properly or
you feel discomfort, immediately stop using the
device.
n Do not use for any other purpose except as
described in this manual.
n Do not mix alkaline and manganese batteries, as
this will shorten the battery life.
n Do not use the TENS device while wearing
electronic devices such as watches as this may
damage the device.
n Do not throw the batteries into a fire. The
batteries may explode.
n Dispose of the device, batteries, and
components according to applicable legal
regulations. Unlawful disposal may cause
environmental pollution.
n The size, shape and type of pads may affect the
safety and effectiveness of electrical stimulation.
Use only the AccuRelief™ brand electrodes
(AccuRelief™ Supply Kit – ACRL-0003) designed
specifically for the ACRL-9000 Wireless
TENS device.
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GENERAL PRECAUTIONS
n The long-term effects of electrical stimulation are
unknown.
n Apply stimulation to only normal, intact, clean,
dry, and healthy skin.
n TENS is not effective in treating the original
source or cause of the pain, including
headache.
n TENS is not a substitute for pain medications
and other pain management therapies.
n TENS devices do not cure diseases or injuries.
n TENS is a symptomatic treatment and, as such,
suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
n Effectiveness is highly dependent upon patient
selection by a practitioner qualified in the
management of pain patients.
n You may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel) on the
electrodes.
n If you have suspected or diagnosed heart
disease, you should follow precautions
recommended by your physician.
n If you have suspected or diagnosed epilepsy,
you should follow precautions recommended by
your physician.
n Use caution if you have a tendency to bleed
internally, such as following an injury or fracture.
n Consult with your physician prior to using
the device after a recent surgical procedure,
because stimulation may disrupt the healing
process.
n This stimulation should not be applied over the
menstruating or pregnant uterus.
n This stimulation should not be applied over
areas of skin that lack normal sensation.
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