EMSI FLEX-MT PLUS User manual

Instruction Manual
Please read the Instruction
Manual prior to use.
CAUTION: Federal law requires a prescription from your physician before use of this product.

3504 Cragmont Dr. Suite #100 |Tampa, FL 33619
P: 800.588.8383 |813.931.2369 |F: 800.588.9282 | E: [e-mail]

CAUTION: Federal law requires a prescription from your physician before use of this product.

table of contents
1.0 Intended Use.......................................................... 5
2.0 ........................................................ 5
3.0 Contraindications .................................................. 6
4.0 Warnings................................................................ 6
5.0 Precautions............................................................. 8
6.0 Adverse Reactions................................................... 9
7.0 Unit Description.................................................... 10
8.0 Specifications.......................................................... 13
9.0 TENS Stimulation Mode Descriptions.................. 14
16.0 Waveform Reference................................................ 33
10.0 EMS Treatment Functions Descriptions............... 17
11.0 Instructions For Use............................................... 18
12.0 Patient Compliance Timer..................................... 24
13.0 Care and Maintenance........................................... 25
14.0 Troubleshooting..................................................... 27
15.0 Declarations-EMC................................................. 28

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1.0 | Intended Use
e EMSI Flex-MT® Plus is design for the following:
TENS- Transcutaneous Nerve Stimulation
> Symptomatic relief of chronic intractable pain
>Post traumatic and post surgical pain relief
EMS- Electrical Muscle Stimulation
> Relaxation of muscle spasm
> Increasing local blood circulation
> Muscle re-education
> Prevention or retardation of disuse atrophy
> Prevention of venous thrombosis of the calf muscles immediately after surgery
> Maintaining or increase range of motion
2.0
page will show you how to use and care for your device in the general manner. You should be particularly
familiar with the prescription information and precautions before proceeding.
You should consult with your clinician if you have specific questions or problems regarding the use of your device.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

3.0 | Contraindications
1. Any electrode placement that applies current to the carotid sinus (front of neck) region.
2. Any electrode placement that causes current to flow transcerebrally (through the head).
3. Any use of this device on patients who have a demand-type cardiac pacemaker.
4.0 | Warnings
1.
2. Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reex.
3. Stimulation should not be applied over the front of neck or mouth. Severe spasm of the laryngeal
and pharyngeal muscles may occur and the contractions may occur and may be strong
enough to close the airway or cause diculty in breathing.
4. Stimulation should not be applied trans-thoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
5. Stimulation should not be applied over swollen, infected, or inamed areas or skin eruptions,
e.g., phlebitis, thrombophlebitis, varicose veins, etc.
6. Stimulation should not be applied over, or in proximity to, cancerous lesions.
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7. For external use only.
8. Do not use device on the eye area.
9.
10. Safety for use during pregnancy or delivery has not been established.
11. Electronic equipment such as ECG monitors and ECG alarms may not operate properly
when TENS is in use.
12. Apply the electrodes to clean, dry and unbroken skin only.
13.
involuntary muscle contractions may put the user at undue risk of injury.
14.
15.
16.
17. TENS is a symptomatic treatment, and as it suppresses the sensation of pain which would otherwise
serve as a protective mechanism.
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5.0 | Precautions
1. Caution should be used for patients with suspected or diagnosed heart problems.
2. Caution should be used for patients with suspected or diagnosed epilepsy.
3. Caution should be used in the presence of the following:
(a) When there is a tendency to hemorrhage following acute trauma or fracture;
(b) Following recent surgical procedures when muscle contraction may disrupt the healing process.
(c) Over the menstruating or pregnant uterus; and
(d) Over areas of the skin which lack normal sensation.
4. Some patients may experience skin irritation of hypersensitivity due to the electrical stimulation or
medium, or alternate electrode placement.
5. Electrode placement and stimulation settings should be based on the guidance of the
prescribing practitioner.
6.
the manufacturer.
7. Isolated cases of skin irritation may occur at the site of the electrode placement following
long-term application.
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8. Eectiveness is highly dependent upon patient selection by a person qualified in the management
of pain patients.
9. If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation
amplitude to a comfortable level and contact your physician if problems persist.
6.0 | Adverse Reactions
1. Possible skin irritation or electrode burn under the electrodes may occur.
2. Possible allergic skin reaction to tape or gel may occur.
3.
transmitters, e.g. mobile phones or similar mobile radio equipment, airport security systems, or
metal detection devices (which themselves conform to the EMC regulations), may influence the
proper functioning of the device if such equipment is operated in close proximity and with relatively
high transmitting power.
Flex-MT® Plus meets EMC requirements and is designed in such a way, that under normal conditions,
there is no risk of malfunction caused by electromagnetic interference. However, in the case of signals
from high frequency transmitters, the risk of electromagnetic incompatibility when operated in close
proximity to electronic apparatus cannot be totally ruled out. In unusual circumstances, unintended
functions of the Flex-MT® Plus could be initiated, possibly giving rise to undesirable risks for the patient or
user such as a surge in energy level or ineective treatment parameters.

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7.0 | Unit Description
ON/OFF Button: Turns the unit ON and OFF.
Amplitude Controls: Controls the “INTENSITY” level of stimulating pulses.
MODE Button: Choose the TENS or EMS stimulation modes.
SET Button: Set the pulse width, pulse rate, ramp time, on time and o time.
TIMER Button: Sets the timer.
INCREASE & DECREASE Button: Increase and decrease pulse width, pulse rate, ramp time, on
time, o time and choose the timer.
LOCK/UNLOCK Button: Locks or unlocks the unit.
Symmetric/Asymmetric Button: Choose symmetric or asymmetric waveform.

LCD Display
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Recharger Receptacle

7.0 | Unit Description continued
Function Mark
Electrode Leadwires: Two sets of 1100mm (43 inch)
electrode leadwires which are compatible with commercially
available electrodes (standard 0.08 inch female connection)
are provided with the Flex-MT® Plus. Each output jack of
the device is designed to accept a lead wire whose connector
complies with FDA 21 CFR Part 898 requirements.
e Flex-MT® Plus is recommended for use with
the previously cleared Everlife self adhesive
electrodes. (Re-order information on page 26)
Battery Charger:
Input: AC 110V, 50~60Hz, 0.2A
Output: DC 4.8V, 400mA
Accessories
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8.0 | Specifications
EMS/TENS Specifications
Dual, isolated between channels
700 mAh 4.8V Ni-MH rechargeable battery pack
Symmetric or Asymmetric waveform
0~±65V (Loading: 1000Ω)
65mA (Loading: 1000Ω)
Level 1~Level 20: Each level increases ± 3.25V
0~65V (Loading: 1000Ω)
65mA (Loading: 1000Ω)
Level 1~20: Each level increases 3.25V
Variable, 50~400 µs
Variable, 2~150 Hz
1~99 seconds
1~99 seconds
Output
Peak Pulse Output
Level
Output
Peak Pulse Output
Level
Channel:
Power Source:
Output waveform:
Symmetric
Asymmetric
Pulse Width:
Pulse Frequency:
* All values + or - 10%
On Time:
O Time:
EMS only

Ramp
(Ramp Up & Ramp Down)
e time required to reach the pulse width value and amplitude
setup value or from setup value to zero can be selected to be 1~8
seconds. (Ramp up value = Ramp down value).
Patient Compliance Timer Operation count: record of 60 sets (min.), max with 999 mins.
Operation total time: max with 999 hrs.
Operation ambient: Temperature range: 10°C ~ 35°C
Humidity range: 20 ~ 90%RH
Storage & transportation: Temperature Range: 0°C ~ 70°C
Humidity Range: 20 ~ 90%RH
Timer: 5~90 minutes auto-shuto or Constant
Size: L (120mm) x W (54mm) x H (33mm)
Weight 156 grams (including battery)
9.0 | TENS Stimulation Mode Descriptions
button. Be sure that when adjusting these stimulation modes, the intensity output controls should be set
to the minimum output first.
8.0 | Specifications continued
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TENS Mode
MODE Interpretations
Burst
(B)
delivered per second. Positive pulse and negative pulse iterate continuously at fixed
100Hz. Pulse width are adjustable from 50~400µs
Normal
(N)
are not automatically interrupted nor varied in any way. In this mode, the pulse rate
mode is quite versatile because it may be applied with a variety of rate and width settings.
(from 2 to 150Hz) and pulse width (form 50 to 400μs) are fully adjustable. e normal
Modulated
Rate & Width
(MRW)
massage-like sensation. It’s believed that nerves can become accustomed to, or “ac-
commodated” to the same electrical stimulus after a period of time and thus would
produced to oer a variety of dierent electrical stimulation, thus preventing nerve
accommodation so that less intensity is required for long and eective treatment. In
this mode, during the beginning of 05 second period, the WIDTH decreased to
50% of its original setting and then during the next 0 5 second period, the RATE is

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MODE Interpretations
Modulated
Intensity and
Pulse Width
(SD)
so that the intensity is always increasing while the pulse width is decreasing and
-
sity equal to setting). Total cycle time is 6 seconds. Pulse rate (from 2 to 150Hz)
and pulse width (from 50 to 400µs) are fully adjustable.
Bi-Pulse
(Bi-Pulse)
pulse rate of Channel 1 is fixed at 4Hz) while delivering 100 pulses per second
to Channel 2 (i.e. the pulse rate of Channel 2 is fixed at 100Hz). Stimulation
vertical line. Pulse width (from 50 to 400 µs) is fully adjustable.
9.0 | TENS Stimulation Mode Descriptions continued
TENS Mode

MODE Interpretations
Alternative
“A”
-
vated, Channel 2 will be inactivated and vice versa.
Synchronous
“S”duration is controlled by ON TIME and OFF TIME.
10.0 | EMS Treatment Functions Descriptions
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1. Check Battery:
Proceed to insert battery pack into the battery compartment. BE SURE TO MATCH THE
POSITIVE AND NEGATIVE ENDS OF THE BATTERY PACK TO THE MARKINGS IN THE
BATTERY COMPARTMENT OF THE UNIT.
NOTE: Before first and consequent uses, charge battery using the supplied battery charger.
To charge: Plug male end of charger to the socketlocated on theright side of the LCD screen.
Make sure the plug fitssnugly into the socket. PERMANENT DAMAGE MAY OCCUR IFFORCE IS
USED TO PLUG THE MALE END OF THE CHARGER INTO THE SOCKET. A green indicator
light will illuminate and alternately ash as it is being charged. If red or ashing red, check battery for
proper placement. If not solved, call customer serviec. When charging is done (usually 3-4 hours
on a fully discharged battery), a green steady light will illuminate. Typical charge may last several hours of
use depending on frequency and intensity of treatment.
NOTE: e device will NOT work if the charger is plugged into the device. Nor will the device work if
the charger plug is plugged into an outlet. Use of unapproved charger (not issued byEMSI) may cause
damage to device and will void any warranty.
e Specications of Charger:
Input: AC 110V, 50~60Hz, 0.2A
Output: DC 4.8V, 400mA
11.0 | Instructions For Use
NOTE: Always read this instruction manual before use.
PREPARATION FOR USE

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Caution:
1. Always use 1 5” x 1.5” (16cm²) electrodes or larger.
3. Connect lead wires to unit:
Before proceeding to this step, be sure the unit is turned OFF.
Holding the insulated portion of the lead wire connector, insert the angled-“L” plug into the
receptacle on the top of the main unit. Please ensure the lead wires are inserted securely.
Control buttons on the front of the unit. You may choose to use one channel with one pair of lead
wires or both channels with two pairs of lead wires.
Caution: Always use leadwires that came with the unit. Using other leadwires may render
the unit non-operable and void the warranty.
2. e Flex-MT® Plus is compatible and recommended for use with EMSI electrodes
(or comparable). Always use electrodes and leadwires that came with the unit. Using other
electrodes and leadwires may render the unit non-operable, ineective, and void the warranty.
CONNECTING THE STIMULATOR
2. Connect electrodes to lead wires:
Insert the lead wire connector into electrodes connector (standard 0.08 inch female connection).
MAKE SURE THAT NO BARE METAL OF THE PINS IS EXPOSED

4. Place electrodes on skin:
Before applying electrodes, be sure that the skin surface over which electrodes are placed is thor-
oughly cleaned and dried. Apply electrodes to the exact site indicated by your physician following
the instruction included with the electrodes labeling. Make sure that the electrodes are placed firmly
11.0 | Instructions For Use continued
to skin and make good contact between the skin and the electrodes. Place the electrodes over the
skin; attach them properly, firmly and evenly.
5. Treat as directed by prescribing clinician:
• Press the ON/OFF button to turn unit on. Activated Controls will be visible on LCD screen.
Press Mode to select appropriate stimulation mode (5 TENS Options, 2 EMS options).
• Press Set to select unit output for the following as directed by clinician:
- pulse width, pulse rate, ramp time, on time and o time
- adjust to the desired setting by pressing the triangular increase/decrease button.
• Choose Symmetric or Asymmetric waveform by pressing waveform button in lower right
corner of the unit.
• Press the Timer button to set time. Adjust in increments of 5 minutes up to 90, or continuous
by repeatedly pressing the triangular increase/decrease button.
• Adjust the Amplitude (pulse intensity) of Channel 1 and/or Channel 2 as directed by
your clinician.
• To discontinue treatment for any timer setting, press the ON/OFF button.
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