iReliev iRecover et-1313 User manual

Pain Management System
TM
Model: iReliev™
Model #: ET-1313
Operating & Instruction Manual
Read Before Using

iReliev™
Pain Management System
Intended Use
The iReliev™ Pain Management System (Model # ET-1313) is intended for
temporary relief of pain associated with sore and aching muscles in the upper and
lower extremities (arm and/or leg) due to strain from exercise or normal household
and work activities.
Safety Instructions: Contraindications, Warnings, Precautions & Adverse
Reactions ……………………………………………………………………… 1
Introduction to your Pain Management System …………………………… 4
How the iReliev™ System works ………….………………………………… 5
Conditions that may Affect Your System …………………………………… 5
Operating Instructions ………………..……..……………………….………. 6
Care and Maintenance ………………………………………………………. 9
Replacement Parts …………………………………………………………… 10
Troubleshooting Guide .……………………………………………………… 10
iReliev™ ET-1313 Stimulator Technical Specications…………………… 11
Warranty ………………………………………………………………………. 16
Table of Contents

Safety Instructions
Read operating and instruction manual before operation. Be sure to comply with all
“CAUTIONS” and “WARNINGS” in this manual. Failure to follow instructions can cause harm
to user or device.
Please read the following information carefully before using the iReliev™ Pain Management
System.
Contraindications: Do not use this System if any of the following conditions are
present.
 Do not use this System if you have a cardiac pacemaker, implanted debrillators or any
other implanted metallic or electronic device.
Do not use this System if you have undiagnosed chronic pain.
Warnings for proper use and safety
If you have numbness, tingling or loss of feeling and/or sensation in your arms, hands, legs
or feet this may represent a more serous problem like diabetic neuropathy. Consult your
physician before using the iReliev™ device or pain management system.
If you have swelling of the arm or leg, it may be more serious than simple muscle pain from
overuse. Consult your physician before using the device.
If you are under the care of a Physician, consult with your Physician before using this
system.
The long-term effects of the iReliev™ system are not known.
Do not place the electrode pads on or close to your heart.
Do not place the electrode pads around or close to your neck. Do not apply stimulation
over the neck. Severe spasm of the muscles may occur and the contractions may be
strong enough to close the airway or cause difculty in breathing.
Stimulation over the neck could also have adverse effects on hearing or blood pressure.
Do not apply stimulation across the chest because the introduction of electrical current into
the chest may cause rhythm disturbances to the heart.
Do not place the electrode pads on or around your head. The effects of stimulation on the
brain are unknown.
Do not use the electrode pads over or close to sores.
Do not use the iReliev™ system while sleeping.
Do not use if you feel numbness.
Do not use the iReliev™ system in or close to water.
Use the electrode pads only on normal, healthy, clean and dry skin. Do not use the
electrode pads on open wounds or rashes, or over swollen, red, infected or inamed skin.
If you have ever had back surgery, consult your Physician before using the iReliev™
system.
1

Precautions for the safe use of the iReliev™ Pain Management System
 Read this operating and instruction manual before using the iReliev™ system for the rst
time.
 Keep this manual available whenever you use the iReliev™ system.
The iReliev™ system is intended for individual personal use.
The iReliev™ system is not effective for pain associated with central pain syndromes, such
as headaches.
The iReliev™ system is for pain caused by muscle soreness, and should be placed only
around muscles where pain originates.
The pain may indicate that you have some other health problem. You should know the
reason and source of your pain before using the iReliev™ system. Do not rely solely on the
treatment of the iReliev™ system for pain.
The safety of using the iReliev™ system during pregnancy or birth has not been
established.
The effectiveness of the iReliev™ system depends greatly on a person’s individual
physical condition. It may not always be effective for every user.
If you have had medical or physical treatment for muscle pain, consult with your treatment
provider before using the iReliev™ system. You should contact your Physician prior to
using the System following recent surgical procedures. Stimulation may disrupt the
healing process.
Use Caution and consult your Physician before using the iReliev™ system if any of the following
conditions apply to you:
If you have suspected or diagnosed heart problem.
If you have suspected or diagnosed epilepsy.
If you have a tendency to bleed internally following an injury.
If you recently had surgery, or have ever had surgery on your back.
If areas of skin lack normal sensations, such as skin that tingles or is numb.
During menstruation or during pregnancy.
Some people may feel skin irritation or experience a very sensitive feeling in the skin due
to electrical stimulation. If this occurs, stop using your iReliev™ system and consult your
Physician.
If skin under one or more pads feels irritated after using the stimulator for a long period of
time, use the stimulator for a shorter period of time.
Minor redness at stimulation placement is a normal skin reaction. It is not considered
as skin irritation, and it will normally disappear within 30 minutes after the electrodes are
removed. If the redness does not disappear 30 minutes after the removal of the electrode
pads, do not use the iReliev™ stimulator again until after the excessive redness has
disappeared.
Turn off the iReliev™ stimulator if the stimulation feels unpleasant or does not provide pain
relief.
Keep your iReliev™ system out of the reach of children.
Use your stimulator only with the electrode pads, lead wire cables and accessories
recommended by the manufacture.
Do not use the iReliev™ system when driving, operating machinery or when swimming.
Before removing the electrode pads, be sure to turn OFF both power knobs to avoid
unpleasant stimulation.
If your pain does not improve, becomes more than mild or if it continues for four to
six days, stop using the iReliev™ system and consult your Physician.
Adverse Reactions
Skin irritation and burns under the pads have been reported by some people who have
applied electronic stimulators to their skin.
2

Important:
Do not use your iReliev™ system at the same time with any other device that transfers an
electrical current into the body (e.g. another muscle stimulator).
Stop using your iReliev™ system if you are feeling light headed or faint. Consult your
Physician if this happens.
Do not touch the electrode pads, lead connector pins and/or metal studs while the iReliev™
system is in the ON position.
Do not use iReliev™ system if you are wearing a belly button ring. Remove ring before
each session.
Note: If you are in any doubt about using the iReliev™ system for any reason, please consult
your Physician before use.
Electrode Pad Precautions
To reposition the electrode pads during a session, always pause the program currently
running, reposition the pads as directed on page 8 and then restart the program again.
Only use iReliev™ compatible electrode pads with your iReliev™ device. Other electrode
pads may not be compatible. Using non-compatible electrode pads with your device may
compromise or degrade minimum safety standards
The electrode pads are for single person use only.
Do not submerge or immerse the electrode pads into water.
Do not apply solvents of any kind to the electrode pads.
Always ensure the iReliev™ unit is OFF before removing the electrode pads.
 Apply the whole surface of the electrode pads rmly to the skin. Do not use electrode pads
which do not adhere properly to the skin.
If your skin is red under the electrode pad after a session, do not start another session in
the same area until the redness has completely disappeared.
3

Introduction to your iReliev™
Pain Management System
ABOUT THE iReliev™ DEVICE
PACKAGE CONTENTS
1. iReliev™ Device
2. 1 clip holder
3. 4 electrode pads
4. 3 AAA batteries
5. 2 lead wire cables
6. Storage bag
1. Power on / adjust / increase setting key
2. Power off / adjust / decrease setting key
3. Program / therapy time selection
4. CH1 key
5. CH2 key
6. Program number
7. Therapy time remaining
8. CH1 intensity level
9. CH2 intensity level
10. Therapy duration status
11. Lock status indicator
12. Battery status indicator
13. Batteries compartment
14. Battery cover
4
FRONT VIEW REAR VIEW

8. CH1 intensity level
9. CH2 intensity level
10. Therapy duration status
11. Lock status indicator
12. Battery status indicator
13. Batteries compartment
14. Battery cover
How Your iReliev™ System Works
The iReliev™ stimulator generates continuous stimulation pulse, which can create pain
relief. We cannot ensure that pain relief is 100% effective for everyone. However, when used
according to information within this instruction manual, it can be a safe, non-addictive and a
non-invasive pain reliever.
Conditions that may affect your iReliev™ System
Since the stimulator is a battery-operated electronic system, its output performance and
safety may be affected greatly in extreme humidity. Therefore, it is very important to keep the
iReliev™ stimulator and system dry to ensure the safety and performance.
5

Operating Instructions
Preparing the Skin Prior to Stimulation Session
Proper preparation of the skin to be covered by the electrode pads allows more stimulation to
reach targeted tissues, prolongs electrode pad life, and reduces the risk of skin irritation. After
connecting the lead wire(s) to the iReliev™ stimulator, use the following steps to prepare your
skin at the electrode pad placement sites:
1. Determine the placement sites for the electrode pads.
2. Wash the area with mild soap and water (do not use alcohol). Rinse and dry thoroughly.
3. Trim excess body hair from the area with scissors (do not shave).
4. As an option, you may apply skin prep to the area to form a protective barrier on your skin.
Apply, let dry, and apply electrode pads as directed. This will both reduce the chance of
skin irritation and extend the life of your electrode pads.
5. When removing electrode pads, always remove by pulling in the direction of hair growth.
6. It may be helpful to apply skin lotion on electrode pad placement area when not wearing
the electrode pads.
1. Open the battery compartment at the back of the device by pushing the battery cover
labelled “Open” downward (this area features raised marks for easy identication).
2. Insert 3 AAA (1.5 V) batteries in the battery compartment; make sure to match up the\
symbols (+/–).
3. Close the battery cover by carefully placing the stud into the slot in the rear area and sliding
it upward, applying slight pressure.
4. Follow the same procedure when replacing the batteries at a later date.
▲Note : for important precautions regarding the batteries ,please be informed:
• Always use only 3x1.5V(AAA) batteries.
• Keep away from children.
• Do not recharge.
• Do not short-circuit.
• Do not throw into a re.
• Please recycle. Do not dispose of old batteries with your household waste; dispose of them
safely at a recycling center or business where the batteries were purchased.
Inserting/Changing the Batteries
6

Connecting the Cable to the Device
Connect the lead wire to the electrode pads
before applying to the skin.
Turning On the Device
1. Press and hold the ON+ button for one (1) second to
turn on the device.
2. The most recently selected treatment time and program
will ash when the unit is turned on.
▲Note : Do not turn the unit on until all electrodes and
lead wires are properly attached.
▲Note : When stimulating the muscles of the arms or legs
bear in mind that the muscle contraction may
cause involuntary limb movement which could
cause injury to you or others. Always ensure the
limb is secured to prevent movement.
Turning Off the Device
1. The device turns off automatically after the therapy
session time has elapsed.
2. To turn the unit off manually, press the OFF- button for
three (3) seconds. The display will blank and the device
will turn off.
3. In an emergency you may also pull the connector(s)
from the device and then remove the belt.
▲Note : To prevent unpleasant electric shocks, never
remove the device while it is still turned on.
Selecting the Treatment Program Mode
The iReliev™ stimulator (Model # ET-1313) offers eight different preset treatment program
modes. The programs differ with respect to varying pulse widths and frequencies. The
user may choose suitable stimulation mode depending on their personal condition, as
indicated in the following steps:
1. Start from P1; only change each mode after a couple of seconds after
sensing the stimulation of that mode.
2. Choose the suitable mode in which you feel most comfortable. Set the device
on that mode.
3. In the case you don’t feel certain about the most appropriate program mode,
repeat steps 1 & 2.
7

Selecting the Therapy Intensity Level
1. Intensity is adjustable according to the channel selected. Select the channel you wish to
adjust by pressing CH1 or CH2. “CH1” or “CH2” will ash on the display.
2. To increase or decrease the intensity, press ON + (to increase) or OFF – (to decrease)
repeatedly until the desired intensity level ashes on the display.
Note: You will feel the intensity increase or decrease as you select the intensity level.
You can use this as a guide to select a level that is comfortable for you.
3. Press MODE to save your selection.
Placement of the Pads
1. Connect the lead wires to the electrode pad before applying them to the skin.
2. The electrode pad placement chart below illustrates the correct placement of the electrode
pads for a selection of targeted muscles.
Remove the protective plastic shields from the electrode pads before placing the pads onto
your skin. Replace the plastic shields after each session. This prevents the pads from drying
out prematurely.
8

Care and Maintenance
Stimulator
The iReliev™ stimulator may be wiped clean with a small amount of soapy water on a clean
cloth. Do not submerge the iReliev™ stimulator in liquids or expose it to large amounts of
water.
• Never use aggressive cleaning products or stiff brushes to clean the device.
• Remove the batteries before cleaning the iReliev™ device.
• Do not use the iReliev™ device again until it is completely dry.
• Do not expose the device to direct sunlight and protect it from dirt and moisture.
Cables
• Disconnect the cables from the iReliev™ stimulator and electrodes.
• Do not pull on the lead wire cables but on the connectors attached to the ends of the cables.
• Store the stimulator with the lead wire cables in a clean, dry place.
Electrode Pads
The electrode pads are disposable and are assembled with adhesive that will dry after
prolonged usage or storage. Electrode pads should be replaced when they lose their
adhesive quality, or you sense a change in stimulation sensation.
If you’re in doubt about the integrity of the electrode pads, buy new electrode pads from your
authorized iReliev™ distributor(s).
How to Store Your iReliev™ System
1. Store your iReliev™ system at room temperature in a dry place, out of the reach of
children.
2. If the iReliev™ stimulator will not be used for more than a week, remove the batteries from
the stimulator.
9

Replacement Parts
Be sure to use only iReliev™ Arm & Leg Pain Management System parts originally supplied.
The following replacement parts can be ordered:
Troubleshooting Guide
Always check the iReliev™ device and accessories before use to prevent damage and
defects. Check the following:
1. Make sure the batteries have sufcient charge and are not corroded.
2. Make sure the lead wire cables t tightly into the connection sockets of the device. The
table below shows some common defects. If you cannot remedy the defects as described,
contact your authorized iReliev™ distributor if it is not possible to remedy in the manner
described:
Self -adhesive Pads
(set of 4)
iReliev™ Part no. measured by length
and width of electrode size
CM5050 , size 50x50 mm , wired
Defect
The device does not
turn on
The unit does not
turn on even though
new batteries have
been inserted
The device turns on
and then off again
The device turns on,
but does not generate
electric pulses
Cause
No batteries or bad
batteries
Batteries not inserted
properly
Batteries life expired
Lead wire cable(s) not
connected properly,
treatment time has expired
Therapy intensity level
has not been set
Remedy
Replace batteries
Contact customer service
Remove batteries & re-
Insert again
Replace batteries
Connect lead wire cable(s)
properly. Switch unit to the
OFF position and turn it
back on
See section “Selecting the
Therapy Intensity Level” on
page 8
10

iReliev™ (Model # ET-1313) Stimulator Technical Specications
Channel: Dual, isolated between channels.
Pulse amplitude: Adjustable 0 – 80mA peak into 500Ω load each channel.
Pulse Rate: As pre-programming operation mode.
Pulse Width: As pre-programming operation mode.
Software ramp up feature: Pulse width ramp up when change mode.
Timer: 5~60 min. selectable.
LCD: Show modes, pulse rate, pulse width, timer, CH1/CH2, intensity level.
Program modes:
Wave Form: Symmetrical Bi-Phasic square pulse.
Max Charge per Pulse: 20.8 micro-coulombs maximum.
Power Source : 3 x AAA / 4.5 Volt batteries
All electrical specications are ±20% at 500Ω load.
Description of symbols:
(i) There are a number of technical symbols on your iReliev™ unit explained as follows:
Program Max. Phase duration Rate Function mode Wave form Type
P1 80mA 260uS 15Hz Constant A
P5 80mA 260~150uS 60Hz Modulated A
P2 80mA 260uS 60Hz Modulated A
P6 80mA 260uS 7 <->60Hz Modulated C
P3 80mA 260uS 60Hz Constant A
P7 80mA 260~156uS 60Hz Modulated A
P4 80mA 260~150uS 2 ~ 60Hz Modulated B
P8 80mA P1 ~P7 Cycle A/B/C
This symbols means “Serial number“
This symbols means “Attention” consult the
accompanying documents
This symbols means “Manufacturer“
This symbol means “used before”, represent as “YYYY-MM” (for year and month).
This symbol means type BF equipment; this device offers protection against
electrical shock by standard compliance to leakage currents of electrode pad.
(ii) Package of electrode pads are labeled as
follows:
11

Electromagnetic Compatibility
• The device complies with current specications with regard to electromagnetic compatibility
and is suitable for use in all premises, including those designated for private residential
purposes. The radio frequency emissions of the device are extremely low and in all
probability do not cause any interference with other devices in the proximity.
• It is recommended that you do not place the device on top of or close to other electronic
devices. Should you notice any interference with other electrical devices, move the device
or connect it to a different socket.
• Radio equipment may affect the operation of this device.
Electromagnetic Compatibility Information
Guidance and manufacturer’s declaration – electromagnetic emissions
The ET-1313 is intended for use in the electromagnetic environment specied below. The
customer or the user of the ET-1313 should assure that it is used in such an environment.
Emissions
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
uctuations/ icker
emissions IEC
61000-3-3
Compliance
Group 1
Class B
Class C
Complies
Electromagnetic environment - guidance
The ET-1313 uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The ET-1313 is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
12

Guidance and manufacturer’s declaration – electromagnetic immunity
NOTE: UT is the a.c. mains voltage prior to application of the test level
The ET-1313 is intended for use in the electromagnetic environment specied below. The
customer or the user of the ET-1313 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst IEC
61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic eld IEC
61000-4-8
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV line(s)
and neutral
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5s
Not applicable
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV line(s)
and neutral
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5s
3 A/m
Electromagnetic environment
— guidance
Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the ET-1313
requires continued operation
during power mains interruptions, it is
recommended that the
ET-1313 be powered from an
uninterruptible power supply or a
battery
Not applicable
13

Guidance and manufacturer’s declaration – electromagnetic immunity
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
a.) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
ET-1313 is used exceeds the applicable RFcompliance level above, the ET-1313 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the ET-1313.
b.) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
The ET-1313 is intended for use in the electromagnetic environment specied below. The
customer or the user of the ET-1313 should assure that it is used in such an environment.
Immunity test
Conducted RF IEC
61000-4-6
Conducted RF IEC
61000-4-6
Compliance level
3 Vrms
3 Vrms
IEC 60601
test level
3 Vrms
150 kHz
to 80 MHz
3 Vrms
150 kHz
to 80 MHz
Electromagnetic environment
— guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
ET-1313 , including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation Distance in metres (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity
of equipment marked with the following
symbol:
14

Recommended separation distances between portable and mobile RF
communications equipment and the ET-1313
The ET-1313 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the ET-1313 help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
ET-1313 as recommended below, according to the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects and people.
Rated maximum
output power of
transmitter
W150 kHz to 80 MHz
0.12
0.38
1.2
3.8
12
0.01
0.1
1
10
100
Separation distance according to frequency of transmitter
m
80 MHz to 800 MHz
0.12
0.38
1.2
3.8
12
800 MHz to 2.5 GHz
0.23
0.73
2.3
7.3
23
15

Warranty
This iReliev™ Arm & Leg Pain Management System carries a one-year warranty from the date
of purchase.
The warranty applies to the iReliev™ Arm & Leg Pain Management System and necessary
parts and labor relating thereto. The distributor reserves the right to replace or repair the unit
at their discretion.
The warranty does not apply to damage resulting from failure to follow the operating
instructions, accidents, abuse, alterations or disassembly by unauthorized individuals.
ExcelHealth Inc.
www.ExcelHealthInc.com
102 Trewin School Road
Park City, Montana 59063
www.iReliev.com
Pain Management System
TM
Made in Taiwan
IM-24-046RevB14
FDA-2407
16