AccuRelief ACRL-9100 User manual

Wireless 3-in-1
Pain Relief Device
User Manual
Clinically
Proven
Model ACRL-9100

This manual is valid for the Wireless 3-in-1 Pain Relief Device ACRL-9100
This instruction manual is published Carex Health Brands
Carex Health Brands reserves the right to improve and amend it at any time
without prior notice. Amendments may however be published in new editions of this manual.
The device complies with all the standards relating to Class ll electrical medical devices and
to devices which use electrical stimulation for use at home.
All Rights Reserved.Rev.V1.0 © 2017
Conformity to safety standards
Carex Health Brands declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC62366, IEC60601-1-11
ISO10993-5, ISO10993-10, ISO10993-1, ISO14971

3
TABLE OF CONTENS
Introduction ...............................................................................................................................4
Important safety precautions and warnings .................................................................................5
How TENS works for pain relief.................................................................................................12
How EMS works for muscle stimulation.....................................................................................13
Package contents.....................................................................................................................14
Know your device.....................................................................................................................15
Charging...................................................................................................................................18
Easy steps to get started with your therapy with electrode pads..................................................
19
Cleaning and storage................................................................................................................26
Specifications...........................................................................................................................28
How to control and reduce your pain.........................................................................................30
Troubleshooting .......................................................................................................................32
Product/Battery disposal...........................................................................................................34
Glossary of symbols..................................................................................................................34
Important information regarding electromagnetic compatibility (EMC) .......................................35
FCC Compliance information....................................................................................................... 42
Warranty..................................................................................................................................43

4
n EMS: The device is designed to be used to
stimulate healthy muscles in order to improve
and facilitate muscle performance.
It should be applied to normal, healthy, dry and
clean skin of adult patients. It is design to be used
at home.
INTRODUCTION
Thank you for purchasing the Wireless 3-in-1
Pain Relief Device ACRL-9100
for your pain
relief solution.
In order to use the stimulator safely, read the
complete manual carefully before using the device
for the first time.
Keep this instruction manual in a convenient place
or store with the device for future reference.
Indications for use:
n 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) and lower
extremities (leg) due to strain from exercise or
normal household work activities.
No.
Standard Parts:
DESCRIPTION QUANTITY
AACRL-9100 1PC
BElectrode pad (2 in. x 2 in) 4PCS
CInstruction manual 1PC
DMicro-USB cable 1PC
ERemote control 1PC
The package contains the following components:

5
SAFETY SYMBOLS USED IN THIS MANUAL
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
DANGER
Indicates a potentially hazardous situation
which, if not avoided, could result in death
or serious injury.
WARNING
Indicates a potentially hazardous situation
which, if not avoided, could result in serious
injury and equipment damage.
n Internally transplanted electronic
medical devices, such as a pacemaker.
n Electronic life support equipment, such
as respirators.
n Electronic medical devices attached to the body,
such as electrocardiographs.
CAUTION
Indicates a potentially hazardous situation
which, if not avoided, may result in minor
or moderate injury to the user or patient or
damage to the device or other property.
This stimulator must not be used in combination
with the following medical devices:

6
DO NOT USE THIS DEVICE DURING
THESE ACTIVITIES
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.
n When in the bath or shower;
n While sleeping;
n While driving, operating machinery, or during
any activity in which electrical stimulation can
put you at risk for injury.
WARNING
n Consult with your physician before using this
device, because the device may cause lethal
rhythm disturbances in certain susceptible
individuals.
n On open wounds or rashes, or over swollen, red,
infected, or 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 Stimulation should not take place while the user is
connected to high-frequency surgical equipment,
it may cause burn injuries on the skin under the
electrodes, as well as problems with the stimulator.
n Do not use the stimulator in the vicinity of shortwave
or microwave therapy equipment, since this may
affect the output power of the stimulator.
DO NOT USE THIS DEVICE UNDER
THESE CONDITIONS:

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
Stimulator.
7
WARNINGS AND PRECAUTIONS
REGARDING THE PADS
n Apply pads to normal, healthy, dry, clean 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.
n Pads should not touch each other when placed
onto your skin.
n Pads must be placed at least 2 in apart.
n Both sides of the thorax simultaneously
or across your chest because the
introduction of electrical current may
cause rhythm disturbances which could
be lethal.
NEVER APPLY THE PADS TO
n The head or any area of the face.
n Never apply the pads to the side
of the neck (on the carotid sinus)
or any area of the throat (front of
the neck) because this could cause
severe muscle spasms resulting in
closure of the airway, difficulty in
breathing, or adverse effects on
heart rhythm or blood pressure.
WARNING
DANGER

n Do not bend or fold because the pad may
not function properly. Place the pads onto
the plastic film and then store into 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 disrupt 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 Always place the electrodes in accordance with
illustrations provided (Refer to the Pad Placement
illustrations).
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.
8
CAUTION
DO NOT USE YOUR PADS THIS WAY
 Pads should not touch each other when placed
onto your skin. Pads should be at least 2 in apart.
 Do not place on your spine or backbone.
WARNING
 If you have suspected or diagnosed heart disease,
you should follow precautions recommended by
your physician.
 If you have suspected or diagnosed epilepsy,
you should follow precautions recommended
by your physician.
 Consult your physician if you have a tendency
to bleed internally, such as following an injury
or fracture.
 This stimulation should not be applied over
the menstruating or pregnant uterus.

 Pad should not touch any metal object, such as a
belt buckle or necklace.
 Do not share pads with another person. This may
cause a skin irritation or infection. Pads are
intended for use by one person.
 Always turn the power off before removing or
changing the pad location.
 Do not leave pads attached to the skin after
treatment.
 If the stimulator is not functioning properly or you
feel discomfort, immediately stop using the device.
 Do not use for any other purpose except for what it
is intended for.
 Do not use the device while wearing electronic
devices such as watches as this may damage the
device.
 Dispose of the device, batteries, and components
according to applicable legal regulations. Unlawful
disposal may cause environmental pollution.
 The size, shape and type of pads may affect the
safety and effectiveness of electrical stimulation.
 The electrical performance characteristics of pads
may affect the safety and effectiveness of electrical
stimulation.
 Using pads that are too small or incorrectly applied,
could result in discomfort or skin burns.
9
CAUTION WHILE USING THE STIMULATOR
CAUTION:
 The user is the intended operator.
 The long-term effects of electrical stimulation
are unknown.
 Apply stimulation to only normal, intact, clean,
dry, and healthy skin.
 TENS is not effective in treating the original
source or cause of the pain, including headache.
GENERAL PRECAUTIONS
CAUTION:

10
 TENS is not a substitute for pain medications
and other pain management therapies.
 TENS devices do not cure disease or injuries.
 TENS is a symptomatic treatment and, as such,
suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
n Keep unit away from young children. The
unit contains small pieces that may be
swallowed. Contact your physician
immediately if ingested.
n Use this device only with the electrodes and
Micro-USB cable recommended by the
manufacturer.
n Keep unit out of the reach of young
children. The cable can cause
strangulation.
nDo not use the device if it is closer than 12
inches (30.5cm) to wireless communication
equipment, such as wireless home network
routers, cell phones, cordless phones and their
base stations, and walkie-talkies. The
electromagnetic interference of this wireless
communication equipment may prevent the
device from operating properly.
nIf you have any problems with this device, such
as setting up, maintaining or using, please
contact Carex Health Brands.

You may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel).
 Consult with your physician prior to using the
device after a recent surgical procedure,
because stimulation may disrupt the healing
process.
 This stimulation should not be applied over
areas of skin that lack normal sensation.
CAUTION:

11
Possible Adverse Reactions
n Do not use to treat one region for extended
periods of time (more than 30 minutes a session,
up to 3 times/day) or muscles in that region may
become exhausted and sore.
n You may experience skin irritation and burns
beneath the stimulation electrodes applied to your
skin.
n You should stop using the device and consult with
your physician if you experience adverse reactions
from the device.
CAUTION:

12
HOW TENS WORKS FOR PAIN RELIEF
The Wireless 3-in-1 Pain Relief Device ACRL-9100
is a single output channel TENS machine and highly
effective in temporarily relieving pain. TENS therapy
is now regularly recommended by doctors,
physiotherapists and pharmacists throughout
the world.
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 cure any physiological problem;
it only helps control the pain. TENS does not work
for everyone; however, in most patients it is effective
in temporarily reducing or eliminating the pain,
allowing for a return to normal activity.
Scientific theory suggests that electrical stimulation
therapy may work in several ways:
nThe gentle electrical pulses move through the
skin to nearby nerves to block or shut out the
pain message from ever reaching the brain from
the source of the pain.
nThe gentle electrical pulses increase the
production of the body’s natural pain killer, such
as endorphins.
What is it? How TENS works?

13
HOW EMS WORKS FOR MUSCLE STIMULATION
EMS works by sending electronic pulses to the
muscle needing treatment; this causes the muscle
to exercise passively. It is a product derived from
the square waveform (ladder‐shaped). Through
the square wave pattern it is able to work directly
on muscle motor neurons. This device has low
frequency and this in conjunction with the square
wave pattern allows direct work on muscle groupings.
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.
How MASSAGE works?
The massage stimulation program is a type of low
level EMS used to loosen tight muscles. Its main
function is to mimic manual massage to promote
relaxation and reduce muscle tension.
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. Then when the pulse ceases,
the muscle relaxes and the cycle is repeated.
What is it?
How EMS works?

14
ACRL-9100 Unit Remote Controller
PACKAGE CONTENTS
Electrode Pads (2 in. x 2 in.) Instruction Manual
AAA batteries Micro-USB cable
Quick Start Guide
Wireless 3-in-1
Pain Relief Device
User Manual
Clinically
Proven
Model ACRL-9100
Model ACRL-9100
QUICK START GUIDE
Clinically
Proven
Ensure that the Bluetooth (4.0) connection is activated on your
smartphone or tablet.
Wireless 3-in-1
Pain Relief Device
Apply pads to normal, healthy,clean and dry skin of adult patients because i t may
otherwise disrupt thehealing process.
If you experience any skin irritation or redness after a session, donot continue
stimulation in that area of the skin.
KNOW YOUR DEVICE
Poweron/o button
TENS
EMS
MASSAGE
RECHARGEABLE
LITHIUMBATTARY
3 IN 1
14
PROGRAMS
Whenyou open the Wireless 3-in1 app in your
mobilephone, the app asks you to turn on
Bluetooth.Please accept.
-For iOS: Press settings to turn on Bluetooth.
-For Android: Press "allow" to turn on Bluetooth.
2
PLACE THE GEL PADS
ON THE SKIN
CONNECT THE GEL PADS
TO THE DEVICE
1TURN ON THE BLUETOOTH
Eachgel pad is pre-fixed
witha stud to connect
tothe back of the device,
andis protected by a
transparentfilm.
Attachthe gel pads
tothe back of the
device,pressing
themin place.
3
Clipexcess hair
fromthe area to be
treated.Wash with
soapand water,
anddry completely.
Removethe
protectivefilm
layerand apply
thegel pad to the
skin.Press firmly
toensure adhesion.
Seethe Recommended Gel
PadPositions on reverse page.
4
TURN ON THE ACRL-9100
UNIT AND START A SESSION
THROUGH THE USE OF THE
DEVICE APPLICATION
Pressthe on/off button so that the
applianceis put on standby mode
(Continuousgreen light : Standby
mode,ready for the session).
TheApp will detect the device
whenit is switched on. In case
ofinactivity for more than 5 min,
thedevice switches off. Simply
pressthe on/off button again to
reenterstandby mode. Press the
nameof the device on your app
screento enter main menu.
ACRL-9100---Disconnected
SELECT THE AREA
TO BE TREATED
Tostart a new session, select a program
(TENS,EMS or Massage) and using the
labelson the front and back of the body
imageselect the area you wish to treat.
5
ACRL-9100
ESTIMATE THE INTENSITY
OF PAIN (IN TENS MODE)
Ona scale of 1 to 10, evaluate the intensity of
thepain. For no pain press 0, for extremely
intensepain press 10.
6
SELECT AND START A
SESSION.
Startinga session : Click on “+” button
tobegin increasing intensity. When your
sessionis complete, estimate your
satisfactionlevel. The session will be
recordedin the History folder of the app.
Toturn off, press the power button on
theapp or device. Remove the
electrodesfrom the skin. Remove the
devicefrom the electrodes. If the device
isidle for more than 5 minutes, it will turn off.
Makesure the device is turned off before removing the electrodes.
7

KNOW YOUR DEVICE
Features
n Channels: One channel
n Treatment modes TENS: 6 programs
EMS: 5 programs
MASSAGE: 3 programs
n Output Amplitude: 0-60mA (1000 Ω Load)
n Waveform type: Symmetrical Biphasic square pulse
n Control platform APP control (ios or Android) and
Remote control
Front and Rear Panel
1
2
3
1. On/off button [ ]: Press this button to turn on
the device or turn off the device.
n Green Flashing indicator light: The device hasn't
connected with APP or the Remote Controller;
n Continuous green: The device is in standby
mode;
n Continuous Orange: The device is in treatment
mode;
n Orange flashing: The device is in paused mode;
2. Indicator light when charging:
n Continuous orange: The battery is charging;
n Continuous green: The battery is fully charged.
3. Device charging port:
n Connect the Micro-USB cable and the adaptor
to the device port to charge;
15

16
Power
ON/OFF
button
Mode select
(TENS/EMS/
MASSAGE)
LCD DISPLAY
Intensity increase
Treatment proqram
select: Neck/
Shoulder/Arm/
LBack/Joint/Leg
Tap/Knead/Rub
Intensity
decrease

LCD Display
17
Treatment time icon
Treatment time display
Treatment program
Intensity icon
Low battry icon
Lock Icon
Treatment mode
Treatment intensity display

CHARGING
NOTES:
18
nOnly use the Micro-USB cable which is
provided by the manufacturer.
nDevice must be charged prior to first use.
Typically it takes 2 hours to charge the device.
A full charge allows a battery life of about 4
hours continuously when functioning in normal
(ambient temperature) conditions.
nPlease charge the device fully before beginning
each session. If the charge is not complete at the
beginning of a program, the battery may become
depleted before the end of the session. You
cannot use the device while it is charging.
nIf batteries leak and come into contact
with the skin or eyes, wash immediately with
copious amounts of water.
nDispose of the used batteries safely according to
the local regulations.
nThe life of a rechargeable battery depends on
the number of recharging/rundown cycles it
undergoes and how these cycles are performed.
The service life of rechargeable battery is more
than 300 recharging/rundown cycles. We provide
the following suggestions to extend the life of the
battery:
nWhenever the device is not used frequently, we
recommend recharging the battery once a month.
Insert the Micro-USB plug of the
Micro-USB cable into the Micro-USB
charging port of the ACRL-9100 device,
and then connect to the Standard
USB plug of the Micro-USB cable
to the appropriate power supply
device which could output 5V d.c. ,
300mA.When the battery light goes from
continuous orange (which means that the
battery is being charged) to a continuous green
(the battery is full), remove the micro-USB plug
from the micro-USB socket of the device.
WARNING:

STEP 4
Using the APP to control main device:
Step 1 Downloading the APP
Step 2– Cleaning of skin Step 4–Placing the gel pads
Download the application to your smart phone :
nBy the Appstore or Google Play
nThen search ‘ACRL-9100’, and click the Smart
Pain Reliever ACRL-9100 icon.
The app operates on ios and Android platforms
(At least ios 8.0, Android 5.0)
Step 3– Preparation of the ACRL-9100 unit
Each gel pad is pre-fixed with a
male snap to connect to the back
of the device, and is protected
by a transparent film. Press the
male snap of the gel pad to the
female snap of the device as
shown in the picture on the right:
Clip excess hair from the treatment area and
remove any jewelry that may come in contact
with the stimulation of the device. Wash area
with soap and water, and dry completely.
EASY STEPS TO GET STARTED WITH YOUR THERAPY WITH ELECTRODE PADS
19
Place electrodes on clean, dry and healthy skin at
least 2 in. apart and do not let them touch. Make
sure there is a linear path between the two
electrodes. (See the pages 22-23).
Note: Replace the electrodes when they are
damaged or dirty, when they have lost their
adhesive power or when stimulation becomes
uncomfortable, i.e. when you experience an
unpleasant stinging or biting sensation.

20
Note: Always connect the device before you place
the electrodes on the skin.
Note: DO NOT place the electrodes on top of each
other or so close to each other that they touch each
other.
Note: It is possible that you may need external
assistance for placing the electrodes in certain areas.
Replace the electrodes if:
nthey are damaged or torn.
nthey are past the use-by date indicated on the
re-sealable bag.
nthey have lost their adhesive power. Never use
plaster or tape to attach them to your skin.
nstimulation feels less strong.
nwhen stimulation is uncomfortable, i.e. when you
experience an unpleasant stinging or biting
sensation.
Note: Always replace the electrodes with electrodes
recommended for this device by the manufacturer.
WARNING: Make sure the device is turned
off before applying electrodes.
WARNING: Place the electrode pads
according to the electrode Pad placement
illustrations, on pages 22-23.
WARNING: