Proactive alevia 715-425 User manual

Physiotherapy • Physiothérapie
2-in-1 Physiotherapy Device
A.M.G. Medical Inc.
8505 Dalton, Montréal, QC H4T 1V5
Canada • 1-800-363-2381
Distributed in the USA by:
AMG Medical, Inc. (USA)
8396 State Route 9, West Chazy, NY 12992
USA • 1-888-412-4992
Rev4 0722 P/N 861-715425
Manufactured in China
Instructions
Please read this manual thoroughly
before using this device for the first time.
Model: 715-425
715-425 TENS instructions EN rev3 0116
715-425 861-715425
24,811 cm x 18,81 cm
Folded: 10,5 cm x 15 cm. Open: 21 cm x 15 cm
This is a double-sided, saddle-stitched instruction booklet.
Jean--François Perron
TM
Generated by : Jean-François Perron
Special Instructions :
This is a double-sided,
saddle-stitched instruction booklet.
Flat Size : 24,811 cm x 18,81 cm
Assembled Size : Folded: 10,5 cm x 15 cm.
Open: 21 cm x 15 cm
Projet : 715-425 TENS Instructions EN Rev4 0722_original
Item No. : 715-425 Part No. : 861-715425
Colours :
B/W CMYK : Spots

2
TABLE OF CONTENTS
INTRODUCTION..................................................................................... 3
What is pain? • What is TENS and how does it work? • What is EMS and how
does it work? • Indications for use • Safety symbols used in this manual
SAFETY PRECAUTIONS AND WARNINGS ........................................... 5
General Precautions • Adverse reactions
CAUTION.................................................................................................8
DEVICE OVERVIEW ............................................................................... 9
DISPLAY SYMBOLS ............................................................................ 10
INSTRUCTIONS FOR USE................................................................... 11
Prepare the Unit • Connect electrodes to lead wires •Connect lead wires
to the device • Place electrodes on skin • Turn the device on • Select the
therapy program (mode) and site • Set the pulse width and rate • Set the
treatment time • Set the on time and relaxation time for EMS mode
•Adjust the intensity for each channel and begin treatment • After
treatment is finished • To consult the memory • To turn off the device
• Low battery indicator
CLEANING AND MAINTENANCE........................................................ 15
Cleaning the device and accessories • Maintenance
• Battery charging
THERAPY PROGRAMS ....................................................................... 17
TENS programs • EMS programs
SKIN CARE RECOMMENDATIONS .................................................... 18
TROUBLESHOOTING........................................................................... 19
STORAGE............................................................................................. 20
DISPOSAL............................................................................................ 20
SYMBOLS ............................................................................................ 21
EMC TABLES....................................................................................... 22
TECHNICAL SPECIFICATIONS ........................................................... 26
LIMITED WARRANTY.......................................................................... 26
TABLE OF CONTENTS
INTRODUCTION..................................................................................... 3
What is pain? • How does TENS work?
What is EMS • What is EMS and how does it work?
and Indications for use
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS...................... 4
Indication for use • Contraindication • Warning
Precautions • Adverse reactions
DEVICE OVERVIEW ............................................................................... 6
DISPLAY SYMBOLS............................................................................... 7
INSTRUCTIONS FOR USE ..................................................................... 8
Prepare the Unit • Connect electrodes to lead wires
Connect lead wires to the device • Place electrodes on skin
Turn the device on • Select the therapy program (mode) and site
Set the pulse width and rate • Set the treatment time
Adjust the intensity for each channel and begin treatment
After treatment is finished • To consult the memory
To turn off the device • Low battery indicator
CLEANING AND MAINTENANCE...................................................... 12
Cleaning the device and accessories • Maintenance Battery
THERAPY PROGRAMS ..................................................................... 14
TENS programs • EMS programs
SKIN CARE RECOMMANDATIONS................................................... 15
TROUBLESHOOTING ........................................................................ 16
STORAGE .......................................................................................... 17
DISPOSAL ......................................................................................... 17
WARRANTY ...................................................................................... 18
TECHNICAL INFORMATION.............................................................. 18

43
INTRODUCTION
This device can be used for pain relief and muscle stimulation. It
provides two independent, controllable output channels. A pair of
electrodes which can be connected to each output channel and the
current's parameters and intensity level can be adjusted according
to your needs.
1. What is pain?
Pain warns our body of injury to prevent additional damage. This
sensation is important because without it, vital parts of our bodies
might be injured without our knowledge. However, long-lasting,
persistent (chronic) pain, once diagnosed serves no apparent
purpose and reduces quality of life.
2. How does TENS work?
TENS (Transcutaneous Electrical Nerve Stimulation) refers to
the transmission of small electrical pulses through the skin to the
underlying peripheral nerves. The theory of TENS suggests two
different modes of operation:
In conventional (high frequency) TENS, continuous mild electrical
activity may block the pain signal traveling to the brain. If the pain
signal does not get through to the brain, the pain is not “felt”.
In low frequency TENS, short bursts of electrical activity may
stimulate the release of endorphins, the body's own pain-control
substance. Ask your physician or therapist for more details. No matter
what pain theory is used, TENS has been proven useful in pain
management for many patients in helping to make their lives better.
3. What is EMS and how does it work?
In normal muscular activity, the central and peripheral nervous
systems transmit electrical signals to the muscles, making them
contract. EMS (Electrical muscle stimulation) uses an external
source (the stimulator, via wires and electrodes) to achieve the
same effect, creating involuntary muscle contractions. This can
help improve and maintain muscle tone without actual physical
activity and therefore prevent atrophy.
4. Indications for use
• 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. And to
be used for the symptomatic relief and management of chronic,
intractable pain and relief of pain associated with arthritis.
• EMS: The device is designed to be used for stimulate healthy
muscles in order to improve and facilitate muscle performance.
This device is recommended for:
• Symptomatic relief of chronic intractable pain, acute post traumatic
pain or acute post surgical pain.
• Improving local blood circulation.
• Relief from muscle spasms.

SAFETY SYMBOLS USED IN THIS MANUAL

Contraindications
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
WARNING
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:
• Internally transplanted electronic medical devices, such as a pacemaker.
• Electronic life support equipment, such as respirators.
• 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.

5 6
SAFETY PRECAUTIONS AND WARNINGS
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS
Undiagnosed pain syndromes (until etiology is established)
• Cancerous lesions that are present in the treatment area
• Swollen, infected, inflamed areas or skin eruptions
(e.g. phlebitis, thrombophlebitis, varicose veins, etc.) • Demand
type implanted pacemaker or defibrillator • Epilepsy • Serious
arterial circulatory problems in the lower limbs • Abdominal or
inguinal hernia • Safety has not been established for use during
pregnancy • Electrical stimulation is not effective on pain that is
of central origin.
For external use only. The long-term effects of frequent electrical
stimulation are unknown. Do not apply stimulation over the thyroid
or carotid sinus regions, as this could disrupt breathing, cardiac
frequency or blood pressure. Do not use while connected to high-
frequency surgical equipment or near shortwave or microwave
therapy equipment. Never use in environments with high humidity
(ex.: bathroom). Never place the electrodes anywhere on the front
of the thorax or transthoracically as it can increase the risk of
ventricular fibrillation, cause cardiac arrhythmia and lead to
cardiac arrest. Never place the electrodes in a way that would
cause the current to flow through the head.
Do not place on your spine or backbone. Never use near the eyes,
the genitals, the heart, or on areas which lack normal sensation.
This stimulator should never be used by patients who are non
compliant or are emotionally, cognitively or mentally impaired.
Keep the stimulator out of reach of children.
WARNING
4. General Precautions
• The patient is the intended operator.
- TENS is a symptomatic treatment and, as such, suppresses the
sensation of pain.
- TENS is not a substitute for pain medications and other pain
management therapies.
- TENS devices do not cure disease or injuries.
- Do not apply electrical muscle stimulation (EMS) over painful
areas. If you have painful areas, you should consult with your
physician before using this device.
- You may experience skin irritation or hypersensitivity due to the
electrical stimulation or gel.
- If you have suspected or diagnosed heart disease and/or epilepsy
you should follow precautions recommended by your physician.
- Use caution if you have a tendency to bleed internally, such as
following an injury or fracture.
- Consult with your physician prior to using the device after a recent
surgical procedure, because stimulation may disrupt the healing
process.
TM
• Use this device only with the Proactive lead wires, gel pads and
Micro-USB cable.
• Do not use the device or an electrode if it is damaged.
The continuous use of a damaged unit may cause injury or
improper results.
• Do not adjust controls while operating machinery or vehicles.
Never use the stimulator during any activity in which involuntary
movement would represent a risk of injury.
• Do not use this device when in the bath or shower
or while sleeping.
• Turn the stimulator off before applying or removing electrodes.

7
TM
• Only use with ProActive lead wires and electrodes.
• Long-term stimulation at the same electrode site may cause
skin irritation. Use only as prescribed by a physician.
• Never use in rooms where aerosols (sprays) are used or pure
oxygen is being administered. Do not use it near
highly flammable substances, gases or explosives.
• Apply the electrodes to clean, dry, and unbroken skin only.
If you experience any skin irritation or redness after a session,
do not continue stimulation in that area of the skin.
• Keep electrodes separate during treatment. Electrodes coming
in contact with each other could result in improper stimulation
or skin burns.
• 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.
• The time required for the device to warm from the minimum
storage temperature (-10°C) between use until the device is
ready for use at ambient temperature (20 °C): about 2 hours.
• The time required for the device to cool from the maximum
storage temperature (55°C) between use until the device is
ready for use at ambient temperature (20 °C): about 2 hours.
5. Adverse reactions
Skin irritation or electrode burn under the electrodes. Allergic skin
reaction to electrode gel may also occur.
You should stop using the device and consult with your physician if
you experience adverse reactions from the device.
8
WARNINGS AND PRECAUTIONS REGARDING THE PADS
• Place the pads at least 1 inch apart on your skin.
The pads should never touch each other.
• Always place the electrodes in accordance with illustrations
provided. (Refer to the Pad Placement illustrations).
• 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
DO NOT USE YOUR PADS THIS WAY
• 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.
• Do not leave pads attached to the skin after treatment.
• Pads should not be placed simultaneously on the soles of both feet.
• Pads should not be placed simultaneously on the calves of both legs.
CAUTION WHILE USING THE STIMULATOR
• 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 pull on the connect wire during treatment.
• Do not use the device while wearing electronic devices such
as watches as this may damage the device.
• 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.
CAUTION
may not be effective.

910
DEVICE OVERVIEW
Channel 1
lead wire
socket
Channel 2
lead wire
socket
Channel 1
intensity
control
Channel 2
intensity
control
Display
screen
(LCD) Parameter
increase
Parameter
decrease
Therapy site
quick select
Mode select
Parameter
setting
Belt clip
Front
Back Top
DISPLAY SYMBOLS
Treatment mode
Pulse
rate
Program
(EMS)
Pulse
width
Memory
Timer
Channel 1
output
intensity
Channel 2
output
intensity
Therapy
site
selector
Time
remaining
Low
battery
indicator
Programs
(TENS) Ramp up
Time /
Contact time
Ramp down
Time /
Relaxatoion
time
USB Port
bottom
Item Quantity/pcs
Alevia TENS Device
Lead wires 2
1
Reusable gel electrode pad 4
Storage 1
USB Cable 1

12
11
INSTRUCTIONS FOR USE
1. Prepare the Unit
TM
Before use, charge the Alevia
with the enclosed USB cable.
It can be plugged into a computer’s
USB port or into a wall socket using
a adaptor (5v 300 mAh adaptor
not included).
When battery is fully charged
the LCD battery indicator
will stop flashing.
Charging time: 3 hours
2. Connect electrodes to lead wires
Insert the lead wire connector into
the electrodes connector, ensuring
that no bare metal remains exposed.
3. Connect lead wires to the device
This device has 2 output channels,
which can be used simultaneously
(with 2 electrode pairs) or individually
(1 channel with 1 electrode pair). After
making sure that the device is turned
off, insert the wire plugs into the sockets
at the top of the unit.
Caution: Always use the lead wires
supplied with this unit.
4. Place electrodes on skin
Ensure that the skin surface where the electrodes will be placed
is clean and dry. The electrodes should be placed firmly and evenly
on the skin to ensure good contact.
Caution:
• Always wash and dry the treatment area. Do not apply any creams
or gels as this may reduce the adhesion of the gel pads.
• Do not turn the device on when the electrodes are not
applied to the treatment area. Never adjust, reposition or
remove the electrodes while the device is still on.
•Always use this device with 4 cm self-adhesive electrodes,
or larger. If they seem to have lost their adhesive properties,
TM
replace with new ProActive electrodes.
Important note: Electrode positioning can be one of the most
important parameters in achieving success with TENS therapy.
5. Turn the device on
Carefully read the contraindications and safety information in this
manual before using for the first time. Turn the intensity control for
either channel 1 or 2 clockwise. The device will beep. Continue as
described below before increasing output intensity.
6. Select the therapy program (mode) and site
Press M until the required mode (EMS or TENS) and body part are
selected. The selected therapy mode will then flash on screen.

1413
7. Set the pulse width and rate
Press S button to enter parameter
setting mode, then use the arrow
buttons to adjust the pulse width.
Then press S again and use the
arrow buttons to adjust the pulse
rateto the value prescribed by your
doctor or therapist.
8. Set the treatment time
Press S, then use the arrow buttons
to adjust the treatment time.
9. Set the on time and relaxation
time for EMS mode
Press S, then use the arrow buttons to first adjust the ramp up time to
reach contraction gradually and smoothly. Press S again, then use the
arrow buttons to secondly adjust the contraction time. Press S again,
then use the arrow buttons to thirdly adjust the ramp down time to
reach relaxation gradually and smoothly. Press S again, then use the
arrow buttons to lastly adjust the relaxation time to reach relaxation
gradually and smoothly. The ranges are adjustable from 1 to 60
seconds depending on the selected therapy.
10. Adjust the intensity for each channel and begin treatment
Slowly turn the intensity control dials clockwise until you reach the
prescribed setting. To further increase the intensity, turn the dials
clockwise. To decrease the intensity or turn the device off, rotate the
dials counterclockwise to the desired setting or to the "OFF" position.
If treatment becomes uncomfortable, decrease the intensity to your
comfort level and contact your doctor or therapist if the problem persists.
11. After treatment is finished
Once the treatment time has elapsed, turn the intensity
control dials counterclockwise to the "OFF" position.
Unplug the lead wires from the device.
To remove the electrodes, lift one edge and gently peel
(do not pull on the lead wires because this may
damage the electrodes). Place the
electrodes on the liner and remove
the lead wire by twisting and
pulling at the same time.
12. To consult the memory
With the unit shut off, press and hold M
and turn one intensity control knob to enter
into memory mode. An M will be displayed
on the screen.
NOTE: The maximum number of
records is 30, after which the oldest one
will be deleted.
Use the arrow keys to navigate between records and S to switch
between data within one record. To clear the memory, press the
quick select button.
13. To turn off the device
Rotate both intensity controls to "0".
14. Low battery indicator
When the indicator flashes, charge the battery as soon as
possible. However, the device will continue to operate for
about one hour.

1615
CLEANING AND MAINTENANCE
1. Stimulator
Wipe the stimulator with a soft, slightly moistened cloth. If a more
thorough cleaning is needed, you can also moisten the cloth with
mild soapy water. Do not submerge the device or expose it to a large
amount of water. Do not use any chemical cleaners or abrasive
agents to clean it. After use, put the stimulator in its storage bag in
a cool, dry place to protect it.
2. Electrodes
• Use the device only with the leads and electrodes provided
with this device or sold under the ProActive brand.
• It is recommended to use at minimum 4 cm self-adhesive
electrodes.
• Inspect your electrodes before every use and replace as needed.
Reusing electrodes too many times may cause slight skin irritation,
low adhesion or ineffective stimulation.
• Between uses, store the electrodes in a resealable bag
in a cool dry place. It may be helpful, between applications,
to moisten their adhesive surface with a few drops of water
(be careful not to over-saturate) and then let them air-dry to
help them last longer.
• If electrodes seem to have lost their adhesive properties,
TM
replace with new ProActive electrodes.
Reusable, self-adhesive electrodes
4. Maintenance
• Do not attempt any repairs to the device or any of its accessories.
Contact us at 1-800-363-2381 for repair information.
• The manufacturer will not be held responsible for the results
of maintenance or repairs by unauthorized persons.
• Check the device before each use for signs of wear and/or
damage. Replace worn items (electrodes, lead wires) as required.
5. Battery charging
Turn off the device if you plug-in the USB cable for charging.
Never turn on the device when the USB cable is plugged in
because this could cause an electrical shock, damage the
device, or the power supply.
• Only use the Micro-USB cable which is provided with your
TM
Alevia device.
• Please charge the unit 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 your session.
You cannot use the unit while it is charging.
• Fully charge the battery of the unit at least every 6 months if the
unit will not be used for a long time.
3. Cleaning the electrode cords
Clean the electrode cords by wiping them with a damp cloth.

1817
THERAPY PROGRAMS
Program Time Rate Width Wave description
TENS Normal 30 100Hz 200µs Continuous
Mod. 30 100Hz 200µs First 0.5 sec.: pulse width at 50%
setting. Next 0.5 sec.: pulse rate
at 50% setting and width at 100%
setting.
Burst 30 100Hz 200µs 9 pulses/burst, 2 bursts/sec.
SD1 30 100Hz 120 ~ Set intensity goes from 100% to
(Strength 200µs 60% then back to 100% while set
duration 1) pulse goes from 60% to 100% and
back to 60%, over 10-second cycles.
SD2 30 100Hz 60 ~ Set intensity goes from 100% to
(Strength 200µs 30% then back to 100% while set
duration 2) pulse goes from 30% to 100% and
back to 30%, over 10-second cycles.
Shoulder 30 2 ~ 100 ~ 12-second cycles, span: 50%.
100Hz 200µs Rate stays in the 2-10Hz range for
1/3 of the cycle time as it modulates
down to 2Hz and back up again.
Neck 30 80Hz 180µs Continuous
Lower 30 100Hz 250/ 1-second cycles, span: 60%.
back 150µs Modulated amplitude via pulse width
0.5 sec. at 100% of set intensity and
0.5 sec. at 50%.
Elbow 30 2 ~ 100/ 12-second cycles, span: 50%
100Hz 200µs Rate stays in the 2-10Hz range for
1/3 of the cycle time as it modulates
down to 2Hz and back up again.
Knee 30 50Hz 200µs 6-second cycles (1 sec. up / 1 sec.
down) then 6 seconds rest.
EMS Alternate 30 50Hz 200µs 6-second cycles (1 sec. up / 1 sec.
down) then 6 seconds rest.
synchronous 30 50Hz 200µs 8-second cycles(2 sec. up / 2 sec.
down) then 4 seconds rest.
Delay 30 40Hz 200µs 11-second cycles (4 sec. up / 2 sec.
down) then 15 sec. rest (1 sec. delay).
THERAPY PROGRAMS (CONTINUED)
Program Time Rate Width Wave description
EMS Neck 30 20Hz 180µs Continuous
Abdomen 30 55Hz 250µs 10-second cycles (2 sec. up / 2 sec.
down) then 8 seconds rest.
Buttocks 30 50/3Hz 250µs/ 13-second cycles (1 sec. up / 2 sec.
370µs down) then 10 sec. rest.
Leg 30 40/4Hz 200µs/ 13-second cycles (1 sec. up / 2 sec.
350µs down) then 10 sec. rest.
Foot 30 55/5Hz 200µs/ 10-second cycles (2 sec. up / 2 sec.
300µs down) then 8 seconds rest.
SKIN CARE RECOMMENDATIONS
• Always clean the treatment area using a mild soap, rinse skin
thoroughly and dry well before applying the electrodes and after
removing them.
• Clip excess hair with scissors – do not shave the treatment area.
• Your doctor or therapist may recommend the use of a skin prep
solution. Let it dry thoroughly before applying the electrodes.
• Avoid stretching the electrode over the skin as this could cause
"pulling stress". Apply the electrode from the center outward to
prevent this from happening.
• When removing the electrodes, pull in the direction of hair growth.
• Never apply the electrodes over irritated or broken skin.

19 20
TROUBLESHOOTING
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.
Problem Possible cause Solution
Display fails
to light up
Low battery Battery may be low and needs
to be charged
Weak or no
stimulation
Electrodes are dried
out or dirty
Electrodes are
improperly positioned
Old / worn / damaged
lead wires
Replace and reconnect the electrodes
Replace the lead wires
Stimulation is
uncomfortable
Intensity is too high Decrease intensity
Electrodes are too
close together
Damaged or worn
electrodes or lead wires
Reposition the electrodes
Replace the lead wires
Electrode active area
is too small
Replace electrodes with ones that are
2
16 cm (4 cm x 4 cm or 1.5” x 1.5”)
or larger
The user instructions are
not being followed
Please check the manual before use
Intermittent
output
Lead wires 1) Verify connection is secure
and firmly in place
2) Turn down the intensity. Rotate lead
wires in socket 90°. If the problem
persists, replace lead wire.
3) If replacing the lead wire does not
solve this problem, contact us at:
1-800-363-2381
Program option in use Some programs will seem intermittent.
This is expected.
Reposition and reconnect
the electrodes
Problem Possible cause Solution
Stimulation
is ineffective
Improper electrode
placement
Reposition electrode
Unknown Contact your doctor
The skin
becomes
red and / or
you feel a
stabbing pain
Repetitive use of
electrodes on the
same site
Reposition the electrodes. If at any
time you feel pain or discomfort, stop
use immediately
Electrodes aren’t
applied on the skin properly
Ensure the electrodes are attached
securely to the skin
The electrodes are dirty Clean the electrode pads with a damp,
lint-free cloth or replace with new
electrodes. Clean the electrode cord
according to the description in the
user manual
The surface of the
electrode is scratched
Replace with a new electrode
Output current
stops during
therapy
The electrode pads
come off the skin
Turn off the device and attach the
electrode firmly to the skin
A cable is disconnected Turn off the device and connect the cable
Battery is low Charge the battery
STORAGE
• Store the device in a cool dry place and protect it against heat,
sunshine, and moisture.
• Never place any heavy objects on the device.
DISPOSAL
Please dispose of the device in accordance with the directive
2012/19/EU WEEE (Waste Electrical and Electronic Equipment).
Contact your local distributor for information regarding disposal
of the unit and accessories.

21 22
SYMBOLS
Type BF applied part
Refer to instruction manual
Transportation and storage temperature
from -10℃ to 55℃
Transportation and storage humidity
limits from 10% to 90%
Transportation and storage atmospheric pressure
limits from 700 hPa to 1060 hPa
Serial number
Dispose of in accordance with EC Regulations on
Waste Electrical and Electronic Equipment (WEEE)
Date of manufacture
Manufacturer
IMPORTANT INFORMATION REGARDING
ELECTROMAGNETIC COMPATIBILITY (EMC)
• This device should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, this device should be observed to verify normal
operation in the configuration in which it will be used.
• Use of accessories other than those specified or provided by the manufacturer of this
device could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
• 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 of
the device, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
• When the operating environment is relatively dry, strong electromagnetic interference
usually occurs. At this time, this device may be affected as follows:
- The device stops output - The device turns off - The device restarts
The above will not affect the basic safety and essential performance of the device,
and the user can use it according to the instructions. If you want to avoid this, please
use it according to the environment requirements specified in the manual.
Declaration - Electromagnetic Emission
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of device should assure that it is used in
such an environment.
Emmission Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Not
applicable
Not
applicable
The device 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 device is suitable for domestic and
in establishments directly connected to
the public low-voltage power supply
network that supplies buildings used
for domestic purposes.
Compliance Electromagnetic Environment - Guidance
Table 1

23 24
Declaration - Electromagnetic Immunity
Table 2
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of device should assure that it is used in
such an environment.
Immunity
Test
IEC 60601
Test level
Compliance
level
Electromagnetic Environment
Guidance
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)
Imagnetic field
30A/m
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
30A/m
± 8 kV contact
± 2 kV, ± 4 kV
± 8 kV, ± 15 kV
air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Not applicable
± 0.5 kV, 1 kV
line(s) to lines
± 0.5 kV, 1 kV,
± 2 kV, line(s)
to earth
0 % UT; 0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle
and 70 % UT;
25/30 cycles
Single phase:
at 0°
0 % UT;
250/300 cycles
Not applicable
Not applicable
± 8 kV contact
± 2 kV, ± 4 kV
± 8 kV, ± 15 kV
air
Floors should be wood, concrete or ceramic
tie. If floors 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.
Main power quality should be that of a typical
commercial or hospital environment. If the
user of the device requires continued
operation during power mains interruptions,
it is recommended that the device be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Declaration - Electromagnetic Immunity
Table 3
The device is intended for use in the electromagnetic environment specified
below.The customer or the user of device should assure that it is used in
such an environment.
Immunity
Test
IEC 60601
Test level
Compliance
level
Electromagnetic Environment
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 reflection from structures, objects and people.
10 V/m
3V
0.15 MHz to
80MHz
6 V in ISM and
amateur radio
bands between
0.15 MHz and
80 MHz
10 V/m
80 MHz
to 2.7 GHz
Not applicable
Portable and mobile RF communications
equipment should be used no closer to any
part of device, 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 meters (m).
Field strengths from fixed 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:
d = 1.2 150 KHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
d = 2.3 80 MHz to 2.7 GHz
a Field strengths from fixed RF 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 fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which device is used exceeds the applicable RF compliance level above, device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating device.
b Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m.

26
TECHNICAL SPECIFICATIONS
• Channel: Two isolated channels
• Power supply: 3.7Vd.c., 500mAh
• Suggested charger: I/P: 100-240V~, 50/60Hz, 0.2A.O/P: 5V d.c.,
300mA. charging: 5V d.c., 300mA
• Waveform: Asymmetrical biphasic square waveform
• Pulse duration: Adjustable, from 50 to 350μs.
• Pulse frequency: Adjustable, from 2 to 100Hz
• Treatment time: 5 to 60 minutes
• Amplitude: 0-40V(Vpp)(Large output 40V±10% at 500 ohm)
• Operating conditions: 0°C to 40°C with a relative humidity
of 30% - 75%, atmospheric pressure from 700 hpa to 1060 hpa
• Storage conditions: -10°C to 55°C with a relative humidity
of 10%~90%, atmospheric pressure from 700 hpa to 1060 hpa
• Dimensions: 110 x 65 x 30.2 mm
• Weight: Including battery: 107 g
• Expected service life of device: 3 years, 26,280 hours
• Expected service life of electrode: 30 times
• Classification: Internally powered equipment, continuous operation
LIMITED WARRANTY
A.M.G. Medical Inc. warrants the stimulator to be free from defects in material
and workmanship for a period of one (1) year, to be proven by means of the
sales receipt or invoice. This warranty is valid for the original purchaser only.
Any alterations, abuse, misuse or accidental damage voids this warranty.
Repairs under warranty do not extend the warranty period. For service under
warranty, call us at: 1-800-363-2381, between 8:30 AM and 5 PM EST.
• The following is excluded under the warranty:
A) All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
B) All damage which is due to repairs or tampering by the customer
or unauthorized third parities.
C) Damage which has arisen during transport from the manufacturer
to the consumer or during transport to the service centre.
D) Accessories which are subject to normal wear and tear.
• Liability for direct or indirect consequential losses caused by the unit are
excluded even if the damage to the unit is accepted as a warranty claim.
25
Recommended separation distances between portable
and mobile RF communications equipment and device
Table 4
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of device
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and device, as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
0.01
0.15 MHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.7 GHz
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 7.3
d = 2.3
d = 1.2 d = 1.2
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 higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.