Ultima NEO User manual

User's Manual
User Manual For Ultima Neo

PRESCRIBING INFORMATION
FOREWORD
Read this manual carefully before using your Ultima NEO
unit.
The manufacturer strongly recommends carefully reading
the “Warnings and Cautions”, and subsequent chapters
of this manual.
WARNINGS AND CAUTIONS
Prescription labeling:
Federal law restricts this device to sale or use by or on
the order of a practitioner appropriately licensed by the
state or province.
Contraindications:
1. Do not use this device on patients who have a
cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device, because this
may cause electric shock, burns, electrical
interference, or death.
2. Do not use this device on patients whose pain
syndromes are undiagnosed.
WARNINGS
1. Do not apply stimulation over the patient’s neck or
mouth because this could cause severe muscle
spasms resulting in closure of the airway, difficulty in
breathing, or adverse effects on heart rhythm or
blood pressure. - 1 -

2. Do not apply stimulation across the patient’s chest,
because the introduction of electrical current into the
chest may cause rhythm disturbances to the
patient’s heart, which could be lethal.
3. Do not apply stimulation over open wounds or
rashes, or over swollen, red, infected, or inflamed
areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins).
4. Do not apply stimulation over, or in proximity to,
cancerous lesions.
5. Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG
alarms), which may not operate properly when the
electrical stimulation device is in use.
6. Do not apply stimulation when the patient is in the
bath or shower.
7. Do not apply stimulation while the patient is sleeping.
8. Do not apply stimulation while the patient is driving,
operating machinery, or during any activity in which
electrical stimulation can put the patient at risk of
injury.
9. Consult with the patient’s physician before using this
device, because the device may cause lethal rhythm
disturbances to the heart in susceptible individuals.
10. Apply stimulation only to normal, intact, clean,
healthy skin.
- 2 -

PRECAUTIONS
1. TENS is not effective for pain of central origin,
including headache.
2. TENS is not a substitute for pain medications and
other pain management therapies.
3. TENS devices have no curative value.
4. TENS is a symptomatic treatment and, as such,
suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
5. Effectiveness is highly dependent upon patient
selection by a practitioner qualified in the
management of pain patients.
6. The long-term effects of electrical stimulation are
unknown.
7. Since the effects of stimulation of the brain are
unknown, stimulation should not be applied across
the head, and electrodes should not be placed on
opposite sides of the head.
8. The safety of electrical stimulation during pregnancy
has not been established.
9. Some patients may experience skin irritation or
hypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).
10. Patients with suspected or diagnosed heart disease
should follow precautions recommended by their
physicians.
11. Patients with suspected or diagnosed epilepsy
should follow precautions recommended by their
physicians. - 3 -

12. Use caution when the patient has a tendency to
bleed internally, such as following an injury or
fracture.
13. Use caution following recent surgical procedures
when stimulation may disrupt the patient’s healing
process.
14. Use caution if stimulation is applied over the
menstruating or pregnant uterus.
15. Use caution if stimulation is applied over areas of
skin with less than normal sensitivity.
16. Keep this device out of the reach of children.
17. Use this device only with the leads, electrodes, and
accessories recommended by the manufacturer.
18. Use this device only under the continued supervision
of a Professional Healthcare Provider.
ADVERSE REACTIONS
·Patients may experience skin irritation and burns
beneath the stimulation electrodes applied to the skin.
·Patients may experience headache and other painful
sensations during or following the application of
electrical stimulation near the eyes and to the head
and face.
·Patients should stop using the device and should
consult with their physicians if they experience
adverse reactions from the device.
- 4 -

GENERAL WARNINGS
1. Do not immerse any part of the unit in water.
2. Do not place the unit close to excessive heat.
3. Do not use any electrodes which are less than
50mm X 50mm.
4. Do not use the unit while asleep.
5. Keep the unit away from sources of high magnetic
fields such as TV’S, microwave ovens, and hi-fi
speakers, as these may affect the LCD screen.
6. Environmental Condition:
Operation temperature and humidity requirements:
Temperature range: +5ºC to + 40ºC
Humidity: 15%to 90% RH non-condensing
Atmospheric pressure: 700hPa to 1060hPa
Storage and transportation temperature and humidity
requirements:
Temperature range: -10ºC to + 60ºC
Humidity: 15% to 75% RH non-condensing
Atmospheric pressure: 700hPa to 1060hPa
- 5 -

CONTENTS
Prescribing Information………………………..…… 1
Contents …...……………………….…………..….. 6
Operating Instructions for Healthcare Provider…. 7
Instruction for Use……………….…………..…….. 9
How toAssemble Your Unit…………….….……… 10
After Use…....……………………….….…..….…… 13
Operation of the ULTIMA NEO Unit……....…… 15
Specifications……………….…..………..…..…….. 19
Other Features…………………………...…....…… 21
Electrodes Placement…………………...………… 24
- 6 -

OPERATING INSTRUCTIONS
FOR HEALTHCARE PROVIDER
INTENDED USE
The Ultima NEO combines the treatment capabilities of a
TENS device, an EMS or NMES device, a MIC stimulator,
and an IFT stimulator all in one unit.
TENS stands for Transcutaneous Electrical Nerve
Stimulation. The TENS settings are used to provide
symptomatic pain relief for chronic, acute or
post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation.
The EMS settings are used to provide a muscular training
for localized regeneration and muscular hypertrophy.
MIC stands for MicroCurrent Stimulation. The MIC
settings are used to provide symptomatic pain relief for
chronic, acute or post-operative pain.
IFTstands for Interferential Stimulation. The IFT settings
are indicated for symptomatic relief of chronic intractable
pain.
How does TENS/EMS/MIC/IFT work?
For the TENS treatment:
Transcutaneous Electrical Nerve Stimulation (TENS)
is believed to work by stimulating your body's own natural
defenses against pain. The unit produces a gentle
stimulus that is communicated through electrodes
normally placed over the area of pain. This stimulus helps
the body to produce natural pain relievers called
endorphins.
The correct positioning of the electrodes is important and
we recommend correct placement through
- 7 -

experimentation. Some people feel immediate benefit
from EMS/TENS, however some may only achieve
benefit after repeated treatment sessions and over an
extended period of time.
For EMS treatment:
Electrical Neuromuscular Stimulation (EMS) is
believed to work by stimulating the muscles with electrical
impulses. When the muscle receives impulses, it
contracts as if the brain has sent the signal itself. As the
pulse strength increases, the muscle flexes as in physical
exercise. Then when the pulse ceases, the muscle
relaxes and the cycle is repeated.
For MIC treatment:
MicroCurrent Stimulation (MIC) is a type of therapy
where very low current is sent into the cells of the body.
MIC is a very faint current that is so small it is measured
in millionths of an amp (Microamps). Human cells
generate a current that is in the micro amp range which is
why some can’t feel it – the current is so low it doesn’t
stimulate the sensory nerves.
MIC is a physiological electric modality that increases
ATP (energy) production in the cells of your body. This
dramatically increases the tissue’s healing rate. The
immediate response to the correct MIC frequency
suggests that other mechanisms are involved as well.
The exact effects or changes in the tissue can be
noticeable; scars can suddenly soften; trigger points often
become less painful when the “correct” frequency is
applied. In many situations the changes can be long
lasting and even permanent in some cases.
For IFT treatment:
Interferential Stimulation (IFT) is an anti-inflammatory
based treatment modality characterized by two
- 8 -

alternating-current sine waves or square waves of
differing frequencies that “work” together to produce an
IFT current that is also known as a beat pulse or
alternating modulation frequency. One of the two currents
is usually held at 4,000 Hz or 8,000 Hz, and the other can
be held constant or varied over a range of 4,000 to 4,150
Hz or 8160Hz. Because of the interference between the
two frequencies, IFT waves create low impedance when
crossing the skin into soft tissues. The IFT currents can
stimulate sensory, motor, and pain fibers. These large
impulse fibers interfere with the transmission of pain
messages at the spinal cord level. This deep tissue
penetration stimulates parasympathetic nerve fibers for
increased blood flow and edema reduction. It utilizes the
low electric-current to stimulate muscle nerves to achieve
the symptomatic relief of chronic intractable pain,
post-traumatic pain, and post-surgical pain.
INSTRUCTIONS FOR USE
Your Ultima NEO has been designed to be simple and
easy to use.
CONTENT IN THE PACK
Your Ultima NEO pack should contain the following:
•1 Ultima NEO Unit
•2 Leads
•4 Self Adhesive Electrodes with Connectors
(Size: 50mm 50mm)
•1 Power adaptor
•1 User Manual
- 9 -

HOW TO ASSEMBLE YOUR UNIT
Assembly of the Ultima NEO Unit is very simple and
requires only four steps.
STEP 1 LEADS
If only using one lead, insert into one jack. If using two
leads, insert into both jacks.
Step A Step B
A: Insert the lead wires
B: Turn the plug on the lead wire 90° to lock it between
the main body and handle of the unit. This prevents
accidental disconnection during treatment.
CH2 CH1
- 10 -

STEP 2 ELECTRODES
Remove electrodes from the bag and connect to the
leads.
5
6
7
- 11 -

STEP 3 PLACEMENT OF ELECTRODES
Ensure wherever you intend to place the electrodes, the
skin is clean and thoroughly dry. Remove the electrodes
from the clear plastic shield and position on your body as
required.
8
9
STEP 4 READING
Read “Operation of the Ultima NEO Unit” on page 15,
and decide how to use the unit for the treatment.
- 12 -

NOTE: AFTER USE
Always ensure that the unit is switched OFF before
removing the electrodes. After use, return the electrodes
to the clear plastic shields. There is no need to separate
the lead wires from the electrodes.
10
Life of the electrodes: When the electrodes initially lose
their adhesive quality, it is possible to reactivate their
adhesiveness by applying a fine spray of water. Replace
the electrodes when they lose their adhesive quality in
order not to affect the efficiency of the unit.
- 13 -

CHARGING THE BATTERY
The Ultima NEO is powered by a built-in rechargeable
polymer battery or directly from the power adaptor.
Separate power adaptor is included in the kit.
When the battery is running low, the battery symbol on
the screen is empty and keep flashing. It is time to charge
the battery. Turn off the unit and connect with the adaptor
to start charging.
Please make sure the unit is off during charging.
Because when the unit is on, it would recognize to
operate with the power adaptor directly, the bulit-in
battery would be disconnected accordingly and could not
be charged.
When charging is in progress, the battery indicator bar
cycles from zero to the max. When the battery charging
has completed, the bar stops cycling and remains at
maximum to indicate full capacity. Remove the adapter
from the device when charging is completed. Once the
adapter is removed from the device, the device will turn
off automatically.
If the rechargeable battery is not used for a long time,
please preserve with electricity (the standard is not less
than 50% of the capacity ). That means it’d better to
charge the battery every 3 months.
NOTE
1. When the battery is running low, it has to be charged
with the power adaptor.
- 14 -

2. Use only the provided power supply adapter that
certified to IEC 60601-1 and IEC 60601-1-11.
3. Only factory provided cords are approved for use.
USE OF OTHER ACCESSORIES OR
OTHTER TYPE OF CHARGER
COULD BE HAZARDOUS
OPERATION OF THE ULTIMA NEO UNIT
Ultima NEO Unit is easy to operate using the buttons
shown in the following diagram.
WHAT DOES EACH BUTTON DO
This button switches the unit on or off. Press once
and the unit is on, the LCD display located at the front of
the unit will light up, there will be no feeling from either
lead at this point as the intensity always starts at zero.
Press this button again and the unit will switch off.
There are four stimulation types available with the
Ultima NEO (TENS, EMS, MicroCurrent and Interferential
- 15 -

stimulation).
Press and hold the “PROG” button at least 3 seconds, to
switch between TENS – EMS –Micro– IFT. The symbol
“TENS”, “EMS”, “Micro” and “IFT” will display on the LCD
accordingly.
Once the stimulation type is selected, press the “PROG”
button to select the related programs as below.
1) TENS Mode
P1 --- Preset program, Endorphin release
P2--- Preset program, Gate control
M--- Manual program
2) EMS Mode
P1 --- Preset program, Rehab
P2--- Preset program, Strengthening
M--- Manual program
3) Micro Mode
P1 --- Preset program,ATP
P2--- Preset program, ATP+
M--- Manual program
4) IFT Mode
P1 --- Preset program, XFreq
P2--- Preset program, XFreq +
M--- Manual program
- 16 -

Press this button to select the following
parameters one by one:
TENS /Micro Preset Mode (P1-P2):
Treatment Timer (min)
TENS Manual Mode (M):
FREQUENCY (Hz)
PULSE WIDTH (μs)
Waveform
Treatment Timer (min)
EMS Manual Mode (M):
FREQUENCY (Hz)
PULSE WIDTH (μs)
Waveform
Treatment Timer (min)
SYNCHRONOUS/ALTERNATING
ON TIME (sec)
OFF TIME (sec)
RAMP UP TIME (sec)
RAMP DOWN TIME (sec)
Micro/IFT Mode (M):
FREQUENCY (Hz)
Treatment Timer (min)
- 17 -

Press these buttons to increase or decrease the
value of the parameter, which has been selected
by MENU button.
Press these buttons to adjust the intensity of
channel 1 and channel 2. Left side is for channel 1;
right side is for channel 2.
Pause button: Press this button to make the unit
pause; to continue treatment, press and hold down
this button again.
Press and hold this button for at least 3 seconds to
LOCK or UNLOCK parameters. When the unit is locked,
only intensity and treatment timer can be adjusted.
The symbol displayed on the LCD screen indicates
that the unit is locked.
Press this button to select different body parts in
TENS/EMS Mode (11 body parts in TENS and 10 body
parts in EMS).
Press this button to enable or disable the backlight
of the device. When the backlight is enabling, each time
when a button is pressed, the backlight is lighted and last
20 seconds.
- 18 -

SPECIFICATIONS
Model: Ultima NEO
Channel Dual, isolated
TENS:
Intensity 0-100mAzero to peak at 500ohm load
Frequency 1-150 Hz
Pulse width 50-250μs in steps of 10μs
Waveform Symmetrical bi-phase rectangular,
Asymmetrical bi-phase rectangular,
Mono-phase rectangular
Treatment timer Continuous, 15, 30, 45, 60, 90min
EMS:
Intensity 0-100mA zero to peak at 500ohm load
Frequency 1-120 Hz
Pulse width 50-400μs, in steps of 50μs
Waveform Symmetrical Bi-Phasic rectangular,
Alternated Bi-Phasicrectangular
Ramp up time 0-8s in steps of 1s
Ramp down time 0-8s in steps of 1s
On time 1-60s in steps of 1s
Off time 0-60s in steps of 1s
Treatment timer Continuous, 10, 20, 30, 45, 60, 90min
Program M– When using ALTERNATIING Frequency,
ensure that the “Ramp Up Time”, “On Time”, and “Ramp
DownTime” equals “Off Time”.
Ramp Up + On Time + Ramp Down = OffTime
- 19 -
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