Elite Medical Multi-Mode Stimulator User manual

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INSTRUCTION
MANUAL
STIMULATOR
REF: MMS Patient Manual 04-08-005 rev. 03 © 2018 Elite Medical Supply of NY, LLC
SPECIFICATIONS
Therapy Output Channels: 2 Therapy Channels
Therapy Output Modes: True interferential and conventional muscle stimulation
Waveform: Symmetrical biphasic square wave with zero net DC
component
Carrier Frequency: 4000 Hz
Interference Frequency (IF): 4001 Hz to 4150 Hz
Net Interferential Frequency:
Output Voltage: 22.5 volts peak / 0 - 45 volts peak-to-peak, adjustable in 1/10
volt increments
Output Current: 0 - 45 milliamps, adjustable
Pulse Width: 125 micro seconds
Power System: 2 AA batteries OR optional AC adapter
Dimensions: 3.2” W x 4.8” L x 1.1” Thick
(81mm W x 122mm L x 27mm Thick)
Weight: 6.0 oz. (167 grams) including batteries
Preset Therapy Protocols: 14 (10 Interferential Stimulation, 4 Muscle Stimulation)
Multi-Mode

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PRECAUTIONARY NOTICES
This device is ONLY
to whom it was prescribed. Use by any other person is prohibited
and could result in injury.
CAUTION: Federal Law (USA) restricts this device to sale by, or on
the order of, a practitioner licensed by the state in which he or she
practices to use or order the use of the device.
PLEASE READ THIS MANUAL BEFORE USE
Prior to use, please read and understand the contraindications,
warnings, precautions and adverse effects relating to this device.
KEEP THIS DEVICE OUT OF THE REACH OF CHILDREN
Follow your physician’s or therapist’s instructions as to which
therapy presets to use, electrode placement and suggested
amplitude levels.
TABLE OF CONTENTS
..................1
Precautionary Notices .................2
Table of Contents ........................2
Package Contents .......................3
Introduction ............................ 3-4
Indications for Use ......................4
Contraindications ........................5
Warnings ....................................5
Precautions ............................. 5-6
Adverse Effects ...........................6
Additional Features .....................7
Pre-Set Therapy Protocols ..........8
Device Controls .........................12
Operation Instructions ...............12
Quick Start Instructions .............13
Therapy Status Screen ..............13
Typical Display Screens ...... 13-14
Troubleshooting ........................14
Care and Maintenance ..............15
Warranty Information ................15
Customer Service .....................15
Manufacturer Information .........16

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PACKAGE CONTENTS
Qty. (1) Multi-Mode Stimulator
Qty. (1) Patient Lead Wire Assembly
Qty. (1) Patient Instruction Manual
Qty. (1) Electrodes
Qty. (4) AA Alkaline Batteries
Qty. (1) Carrying and Storage Case
Optional Accessory
Qty. (1) AC Wall Adapter
WARNING - Only use the supplied UL
approved AC wall adapter. Use of any other
type or brand of wall adapter may cause
damage to the device.
Please read this manual carefully to become familiar with the
before using it.
INTRODUCTION TO ELECTROTHERAPY
True interferential stimulation produces a different stimulation frequency through
“interference” frequency that does change depending on the therapy protocol. When
these two stimulation frequencies cross and “interfere” with each other within the
body, the two frequencies subtract resulting in a third frequency, which is the thera-
peutic frequency “seen” by the targeted injury site. This phenomenon of subtracting
two frequencies to create a third frequency is called “beating”.
The Multi-Mode Stimulator uses a carrier frequency of 4000Hz (hertz or cycles per
second). At this frequency the skin impedance or resistance to the stimulation is at
discomfort for the patient. Interferential stimulation is used to treat chronic and
traumatic pain.
Depending on the pre-set therapy protocol selected, the interference frequency
utilized by the Multi-Mode Stimulator may vary between 4001 to 4150Hz. The

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sophisticated, advanced electronic engineering utilized in the construction of
the Multi-Mode Stimulator produces a very precise and repeatable interference
frequency. This results in accurate therapeutic frequencies at the targeted injury site.
Neuromuscular stimulation uses low frequencies to stimulate the contraction of
muscles. This low frequency electrical current is similar to the electrical impulses
produced by the brain to perform a contraction of muscles. Neuromuscular stim-
ulation uses an electrical pulse generator (Multi-Mode Stimulator), lead wires and
electrodes to bring the electrical current to an individual muscle or muscle group.
A contraction and relaxation rhythm is created in the muscle which helps to relieve
muscle spasms, re-educates muscles, advances range of motion and resumption of
motor control, helps prevent or retard muscle atrophy from disuse and increase local
blood circulation. The treatment is safe and after the initial newness of the tingling
sensation from the electrical current, can even become relaxing for the patient. The
length of contraction and relaxation periods is a matter for discussion with your phy-
sician or therapist. The amplitude or intensity of the treatment is patient controllable.
INTRODUCTION TO THE MULTI-MODE STIMULATOR
The Multi-Mode Stimulator is a high-quality, advanced technology medical device
designed to be used as a combination interferential and muscle stimulator. The
Multi-Mode Stimulator is battery powered or power can be supplied with an AC wall
adapter. Current is generated and controlled by the Multi-Mode Stimulator circuitry
using Texas Instruments®microprocessor chips. These chips provide the Multi-
Mode Stimulator with the greatest degree of control and intelligence on the market
today. The Multi-Mode Stimulator was designed for the homecare market and many
of the Multi-Mode Stimulator features are the result of countless discussions with
patients, physicians and therapists as to what they want and need in a clinic and
home use electrotherapy device.
INDICATIONS FOR USE
Interferential Current Mode:
Symptomatic relief and management of chronic pain and/or as an adjunctive treat-
ment for the management of post-surgical and post-traumatic pain.
Neuromuscular Stimulator Mode:
Relaxationof muscle spasm, increasing local blood circulation, maintaining and increas-
ing range of motion, preventing or retarding disuse atrophy, muscle re-education, and
immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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CONTRAINDICATIONS
Cancer patients and anyone with a demand type cardiac pacemaker should not use
the Multi-Mode Stimulator.
WARNINGS
1. The long-term effects of chronic electrical stimulation are unknown.
2. Stimulation should not be applied over the carotid sinus nerves, particularly in
3. Stimulation should not be applied over the neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur, and the contractions may be
4. Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
5. Stimulation should not be applied transcerebrally.
skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to cancerous lesions.
8. Stimulation should not be used whenever pain syndromes are undiagnosed
until etiology is established.
PRECAUTIONS
1. The safety of electrical stimulation during pregnancy or delivery has not been
established.
2. Caution should be used for patients with suspected or diagnosed heart prob-
lems or epilepsy.
3. KEEP THIS DEVICE OUT OF THE REACH OF CHILDREN.
4. Electrode placement and stimulation settings should be based on the guidance
of a prescribing practitioner.
5. Precautions should be observed in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture,
b. Following surgical procedures when muscle contraction may disrupt the
healing process,
c. Over the menstruating or pregnant uterus,
d. Where sensory nerve damage is present by a loss of normal skin sensation.

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6. Some patients may experience skin irritation or hypersensitivity due to the elec-
trical stimulation or electrically conductive medium. This irritation can usually
be reduced by use of an alternate conductive gel.
7. Interferential stimulation is not effective on pain of central origin. This includes
headache.
8. Interferential stimulation devices should only be used under the continued
supervision of a physician.
9. Interferential stimulation devices have no curative value.
10. Interferential current therapy is a symptomatic treatment and as such sup-
presses the sensation of pain, which would otherwise serve as a protective
mechanism.
11. Electronic monitoring equipment (such as ECG monitors and alarms) may not
operate properly when interferential stimulation is in use.
in the management of pain patients.
14. The Multi-Mode Stimulator should only be used with the patient lead wires
provided with the device or original manufacturer replacement patient lead
wires.
15. The Multi-Mode Stimulator should not be used while driving, operating ma-
chinery or during any activity in which involuntary muscle contractions may put
the user at undue risk of injury.
ADVERSE EFFECTS
1. Skin irritation and burns beneath the electrodes have been reported with the
use of electrical stimulators.
2. Unusually high sensitivity to electrical stimulation may result in skin irritation and
burns beneath the electrodes. If this occurs, discontinue use until the source
has been determined and corrected.

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ADDITIONAL FEATURES
Auto Shut-Off - To control the maximum treatment duration received by a patient,
an automatic shut-off feature is incorporated into the Multi-Mode Stimulator. There
are 20 and 30 minute time limits (depending on the selected preset) for each partic-
ular therapy duration. After the session timer reaches zero, the output amplitude of
minutes in an idle state, the device automatically shuts off to conserve battery power
and prevent inadvertent operation.
Pause/Resume - The Multi-Mode Stimulator includes a pause and resume fea-
ture that allows the user to suspend or “pause” treatment to allow for the readjust-
ment of electrodes or any external interruption such as a phone call. If the user wish-
es to pause treatment, simply press the PAUSE/OFF button once. The screen will
display “PAUSED”. When the user is ready to resume therapy, press the ENTER/ON
button once and the previous therapy will resume where it left off with the excep-
tion that the amplitude (intensity) setting has been reset to zero for safety reasons.
Increase the amplitude to the desired amplitude setting.
Amplitude Lockout - To prevent an accidental increase or decrease of the treat-
ment amplitude (intensity), the Multi-Mode Stimulator has an intra-therapy amplitude
lock feature. Sixty seconds after the last increase or decrease of the amplitude, the
device will go into amplitude lock mode. If the device is in Amplitude Lockout mode
and the user accidentally pushes the “+” or “-” buttons (increase or decrease ampli-
tude) the LCD screen will display a message indicating the amplitude is locked. If the
device is in Amplitude Lockout mode and the user wishes to increase or decrease
the amplitude, they can press the ENTER/ON button to remove the amplitude lock
and then increase or decrease the amplitude as desired.
Quick Start - If the Multi-Mode Stimulator is placed into Therapy Protocol Lock-
out mode the Quick Start feature will be activated. The Quick Start feature is the
fastest and easiest way to start a therapy. Ask your healthcare professional to place
the device into Therapy Protocol Lockout mode.
Multilingual - The Multi-Mode Stimulator’s user interface (the information shown
on the display) is available in three common languages: English, Spanish and
French. To change the language (with the device on) hold down the ENTER/ON
button and at the same time press the “+” button. Scroll through the languages and

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PRE-SET THERAPY PROTOCOLS
Pre-set therapy protocols do not have variable adjustment parameters other than
treatment amplitude (intensity). All functions are subject to treatment time.
Dual Therapy - Output base frequency for set dwell time, then abrupt jump to high
frequency forset dwell time, then repeat. After treatment time reaches ½ total treat-
ment time, smooth ramp from 80 or 100Hz to 150Hz over set sweep time, then back.
Ramp - Smooth ramp from base frequency to high frequency over set sweep time,
then back.
Abrupt -Output base frequency for set dwell time, then abrupt jump to high fre-
quency for set dwell time, then abrupt drop to base frequency, repeat.
Relax and Contract Stimulation (muscle stimulation) - Relax = On for
set dwell time at pre-set base frequency and zero amplitude (intensity), then Con-
tract = fast amplitude ramp to amplitude (intensity) setting and maintain contraction
for set dwell time at preset base frequency of 50Hz. Contraction indicated by
asterisk on screen. The amplitude cannot be increased during the contract state.
PRE-SET THERAPY PROTOCOLS
Protocol # Function Treatment
Timer Base Freq. High Freq. Dwell Time
Protocol 1 Abrupt 2/2 30 minutes 1 Hz 10 Hz 2 seconds
Protocol 2 Abrupt 6/6 30 minutes 1 Hz 20 Hz 6 seconds
Protocol 3 Abrupt 9/9 30 minutes 1 Hz 30 Hz 9 seconds
Protocol 1 Protocol 2 Protocol 3
10Hz
1Hz
2s
2s
20Hz
1Hz
6s
6s
30Hz
1Hz
9s
9s

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PRE-SET THERAPY PROTOCOLS (Continued)
Protocol # Function Treatment
Timer Base Freq. High Freq. Sweep Time
Protocol 4 Ramp 6 sec.
“low” 30 minutes 1 Hz 30 Hz 6 seconds
Protocol 5 Ramp 12 sec.
“high” 30 minutes 80 Hz 150 Hz 12 seconds
Protocol # Function Treatment
Timer Base Freq. High Freq. Sweep Time
Protocol 6 Full Sweep
6 seconds 30 minutes 1 Hz 150 Hz 6 seconds
Protocol 7 Full Sweep
15 seconds 30 minutes 1 Hz 150 Hz 15 seconds
30Hz
1Hz
6s
6s
12s
150Hz
80Hz
12s
12s
24s
150Hz
1Hz
6s
6s
12s
150Hz
1Hz
15s
15s
30s
Protocol 4 Protocol 5
Protocol 6 Protocol 7

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PRE-SET THERAPY PROTOCOLS (Continued)
Protocol # Function
Treatment
Timer Base Freq. High Freq.
Sweep or
Dwell Time
Protocol 8
Dual LOW
Abrupt shift
Ramped shift
15 minutes
15 minutes
1 Hz
80 Hz
6 Hz
150 Hz
6 seconds
6 seconds
Protocol 9
Dual MED
Abrupt shift
Ramped shift
15 minutes
15 minutes
1 Hz
80 Hz
10 Hz
150 Hz
6 seconds
6 seconds
Protocol 10
Dual HIGH
Abrupt shift
Ramped shift
15 minutes
15 minutes
10 Hz
100 Hz
20 Hz
150 Hz
6 seconds
6 seconds
Protocol 8 Protocol 9 Protocol 10
1Hz
6Hz
80Hz
150Hz
6s
6s
6s
6s
Abrupt 15 min. Ramp 15 min.
1Hz
10Hz
80Hz
150Hz
6s
6s
6s
6s
Abrupt 15 min. Ramp 15 min.
10Hz
20Hz
100Hz
150Hz
6s
6s
6s
6s
Abrupt 15 min. Ramp 15 min.

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PRE-SET THERAPY PROTOCOLS (Continued)
Protocol # Function
Treatment
Timer Base Freq. High Freq.
Sweep or
Dwell Time
Protocol 11 Muscle
Simulation 20 minutes 50 Hz 50 Hz 3 sec. ON / 3 sec. OFF
Protocol 12 Muscle
Simulation 20 minutes 50 Hz 50 Hz 3 sec. ON / 6 sec. OFF
Protocol 13 Muscle
Simulation 20 minutes 50 Hz 50 Hz 6 sec. ON / 6 sec. OFF
Protocol 14 Muscle
Simulation 20 minutes 50 Hz 50 Hz 5 sec. ON / 10 sec. OFF
Protocol 11 Protocol 12 Protocol 13 Protocol 14
3s
3s
Contraction
State
Ramp over 1 sec.
Relax
State
6s
3s
Contraction
State
Relax
State
Ramp over 1 sec.
6s
6s
Contraction
State
Relax
State
Ramp over 1 sec.
10s
5s
Contraction
State
Relax
State
Ramp over 1 sec.
All protocol illustrations are for reference and not to scale.

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DEVICE CONTROLS
STOP! Do not use the Multi-Mode Stimulator until you have read the
entire instruction manual, especially the warnings and precautions on
pages 5-6.
STANDARD OPERATION INSTRUCTIONS
1. Begin by placing the electrodes on your skin at the treatment location. Follow
your healthcare professional’s instructions as to the correct placement of the
on the proper placement and attachment of the electrodes. Use care at this
important step.
2. Make sure the stimulator is turned OFF. Connect the lead wires to the elec-
trodes and connect the opposite end to the therapy cable connector on the top
of the stimulator.
3. Turn the stimulator ON. In a few moments, you will see a screen asking you
to make a therapy selection. Using the “+” and “-” buttons scroll through the
protocols until you locate the desired therapy protocol.
4. Press ENTER to select the therapy protocol. The therapy has begun but the
amplitude is set at zero. Increase the amplitude to the level recommended by
your healthcare professional. Use the “+” or “-” buttons to adjust the amplitude
to your desired level.
DC Power Jack
Amplitude increase
and decrease, also
menu scroll buttons
OFF / PAUSE button
Therapy Cable
Connector
LCD Display
ON / ENTER Button
DC Power Jack
Amplitude increase
and decrease, also
menu scroll buttons
OFF / PAUSE button

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QUICK START INSTRUCTIONS
Note to user: your device must be placed in therapy lockout mode by your health-
care professional before you can utilize the quick start feature.
Begin by following steps 1 and 2 in the Standard Operation Instructions section.
To use the device in Quick Start mode simply turn the device on by pressing the
ENTER/ON button.
You will now see the therapy status screen displayed. Your therapy protocol has
been pre-selected for you. Your therapy has begun. Use the “+” or “-“ buttons to
adjust the amplitude to the level recommended by your healthcare professional.
THERAPY STATUS SCREEN
TYPICAL DISPLAY SCREENS
SELECT
PROTOCOL
AMP. LOCK
PRESS
ENTER TO
UNLOCK
THERAPY
COMPLETE
A090 P12
TR 07
Amplitude Setting
(A setting of 90 equals 9 volts)
Therapy Set Number
(In this example Therapy Pre-Set is #12)
Battery Power Remaining
(In this example the battery is full)
Therapy Time Remaining
(In this example 7 minutes remain)
When this screen
is displayed,
scroll through
the 14 preset
therapy protocols
and press the ENTER button to select.
The two screens
to the left will
be displayed
alternately when
the amplitude is
locked for safety
reasons. Press
ENTER to unlock
the amplitude.
When the ampli-
tude is unlocked,
it will be at the previous setting.
This screen will
appear at the
end of a therapy.

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TROUBLESHOOTING
PROBLEM SOLUTION
Device Does Not Turn On
Remove old batteries and disconnect wall adapter. Wait 60
seconds to allow device electronics to power down. Install
fresh batteries or re-connect wall adapter.
Device Turns On, but No
Stimulation is Felt
a. Check all therapy cable connections—both at the stimulator
and electrodes.
b. Remove and reattach electrodes.
c. At a low amplitude wiggle the lead wires—if intermittent
stimulation is felt the lead wires are defective. Please contact
manufacturer for replacement lead wires.
Simulation Felt, but the
Device is Off
Device is defective—DO NOT USE—please contact
manufacturer for repair or replacement.
TYPICAL DISPLAY SCREENS (Continued)
SYSTEM
FAILURE
CONTACT
DEALER
REPLACE
BATTERY
*PAUSED*
PRESS ON
TO
RESUME
This screen
and the one
below will both
appear when
the device
operating system detects a fault.
Do not use the
device if this
screen appears.
This screen will
appear when the
batteries need
to be replaced.
Insert fresh
batteries.
When the device
is in the paused
state, the two
screens to
the left will be
displayed al-
ternately. Press
the ON button
(ON/ENTER) to
resume your
therapy. When
the therapy resumes the amplitude is set to
zero for patient safety reasons.

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CARE AND MAINTENANCE
The Multi-Mode Stimulator is easy to maintain in top condition.
Follow the simple practices below:
• Clean the device by wiping gently with a damp cloth and mild soap
• Do not use any abrasive cleaners
• Do not immerse the device in water or other liquids
• Do not allow the device to be splashed with water or other liquids
• Do not drop the device or treat it roughly
• Store the device in the provided carrying case
• Remove the batteries from the device during storage
WARRANTY INFORMATION
Elite Medical Supply of NY warrants the Multi-Mode Stimulator against any defects
in materials and workmanship for a period of one year from the date the device is
entered into service but no longer than 15 months from the date of sale. Warranty
does not cover accessories such as wall adapter or patient lead wires. Warranty
does not cover batteries or electrodesas these are considered consumables.
CUSTOMER SERVICE
To obtain warranty service please call our customer service line at [phone]
and a customer service representative will assist you.

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MANUFACTURER INFORMATION
Manufactured by Elite Medical Supply of NY, LLC
1900 Ridge Road
Suite #125
West Seneca, NY 14224
[phone]
For questions regarding proper use or to request more supplies, please contact Elite
Medical Supply of NY at: [phone]