Manual Select Combo
Manual Select Combo
INSTRUCTION MANUAL
This manual is valid for the InTENSity Select
TM
1. SAFETY INFORMATION…..…………………………................ 4
1.1 General description
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2. PRESENTATION…………………………………………………..14
2.1 Front and Rear panel
2.2 LCD display
3.SPECIFICATION………………………………………………...…17
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4.INSTRUCTIONS FOR USE ………………………………...…… 23
4.1 Battery
4.2 Connect electrodes to lead wires
4.3 Connect lead wires to device
4.4 Electrodes
4.5 Turn ON
4.6 Select the Therapeutic Mode
4.7 Steps to set a new program
4.8 Adjust Channel Intensity
4.9 Safety Lock Feature
4.10 Stop the treatment
4.11 Turn OFF
4.12 Low battery indicator
5.PROGRAM……………………………………..........................… 33
6.CLEANING AND CARE……………….................................….. 33
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrode cables
6.5 Maintenance
7.TROUBLESHOOTING………………………………….………… 37
8.STORAGE……………………………………………................… 38
9.DISPOSAL………………………………………………….........… 38
10.ELECTROMAGNETIC COMPATIBILITY(EMC)TABLES........ 39
11.GLOSSARY OF SYMBOLS ….............................................. 41
12.WARRANTY………………….................................................. 42
1. Safety information
1.1 General
EXPLANATION OF PAIN
EXPLANATION OF TENS
4
only helps control the pain. TENS does not work for everyone;
however, in most patients it is effective in reducing or eliminating
the pain, allowing for a return to normal activity.
EXPLANATION OF EMS
5
HOW EMS WORKS
The EMS units send comfortable impulses through the skin that
stimulate the nerves in the treatment area. When the muscle
receives this signal it contracts as if the brain has sent the signal
itself. As the signal strength increases, the muscle flexes as in
physical exercise. Then when the pulse ceases, the muscle relaxes
and the cycle is repeated.
The goal of electrical muscle stimulation is to achieve contractions
or vibrations in the muscles. Normal muscular activity is controlled
by the central and peripheral nervous systems, which transmit
electrical signals to the muscles. EMS works similarly but uses an
external source (the stimulator) with electrodes attached to the skin
for transmitting electrical impulses into the body. The impulses
stimulate the nerves to send signals to a specifically targeted
muscle, which reacts by contracting, just as it does with normal
muscular activity.
WHAT IS IF?
6
WHAT IS MICROCURRENT?
7
IMPORTANT SAFETY INFORMATION!
1.4 Contraindications
1.5 Warnings, Cautions and Adverse Reactions
WARNINGS:
9
CAUTIONS:
1) Federal law (USA) restricts this device to sale by or on the
order of a physician.
2) For single patient use only.
3) Keep yourself informed of the contraindications.
4) This stimulator not intended for unattended, personal use by
patients who have noncompliant, emotionally disturbed,
dementia, or low IQ.
5) Read, understand, and practice the warnings, cautions and
operating instructions. Know the limitations and hazards
associated with using any device. Observe the cautionary and
operational decals placed on the unit. Always follow the
operating instructions prescribed by your healthcare
practitioner.
6) The instruction of use was listed; any improper use may be
dangerous.
7) Do not use this device for undiagnosed pain syndromes until
consulting a physician.
8) Patients with an implanted electronic device, such as a cardiac
pacemaker, implanted defibrillator, or any other metallic or
electronic device should not use this device without first
consulting a doctor.
9) Stimulation delivered by this device may be sufficient to cause
electrocution. Electrical current of this magnitude must not flow
through the thorax or across the chest because it may cause a
cardiac arrhythmia.
10) Do not place electrodes on the front of the throat as spasm of
the Laryngeal and Pharyngeal muscle may occur. Stimulation
over the carotid sinus (neck region) may close the airways,
make breathing difficult, and may have adverse effects on the
heart rhythm or blood pressure.
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14) Electrode placement and stimulation settings should be based
on the guidance of prescribing practitioner.
15) Effectiveness is highly dependent upon patient selection by a
person qualified in the management of pain afflicted patients.
16) Isolated cases of skin irritation may occur at the site of the
electrode placement following long-term application. If this
occurs, discontinue use and consult your physician.
17) The electrodes are only to be placed on healthy skin. Avoid
skin irritation by ensuring that good contact is achieved
between electrodes and skin.
18) If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation Intensity to a
comfortable level and contact your physician if problems persist.
19) This device should not be used while driving, operating
machinery, close to water, or during any activity in which
involuntary muscle contractions may put the user at undue risk
of injury.
20) Never use the device in rooms where aerosols (sprays) are
used or pure oxygen is being administered.
21) Do not use it near any highly flammable substances, gases or
explosives.
22) Do not use this device at the same time as other equipment
which sends electrical pulses to your body.
23) Do not confuse the electrode cables and contacts with your
headphones or other devices, and do not connect the
electrodes to other devices.
24) Do not use sharp objects such as pencil point or ballpoint pen
to operate the buttons on the control panel.
25) Inspect Applicator cables and associated connectors before
each use.
26) Turn the device off before applying or removing electrodes.
27) Electrical stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
28) This device has no AP/APG protection. Do not use it in the
presence of explosive atmosphere and flammable mixture.
12
Adverse Reactions:
1) Skin irritation from the electrode gel and electrode burns are
potential adverse reactions. If skin irritation occurs,
discontinue use and consult your physician.
Note: Always use electrodes that are legally marketed and
sold in the United States under 510K guidelines.
2) If the stimulation levels are uncomfortable, reduce the
stimulation Intensity to a comfortable level and contact your
physician if any problems persist.
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2. Presentation
14
8) Decreasing the output intensity of channel 2 [▼]. Use to set
the application program and the parameter of the waveform
in the setting state. Use to unlock the current treatment
program.
9) Parameter Selection: press the button to enter setting state;
you can select the different parameters in conjunction with
[▲] and [ ▼].
10) Press [ ] to turn ON. Press [ ] button and hold for
approximately 3 seconds to turn off the device.
11) Belt Clip.
12) The battery compartment cover for user access.
13) Adapter Receptacle.
3.1 Accessories
18
Technical specifications for Electrical Muscle Stimulation
(EMS) mode
20
3.3 The waveforms of the stimulation programs
Burst (B)
Normal (N)
Alternate (A)
Delay (D)
Interferential
Microcurrent (Constant)
22
4. Instructions for use
4 .1 Battery
4.1.1 Check/Replace the battery
Over time, in order to ensure the
functional safety of device, the battery
must be periodically changed.
1) Slide the battery compartment cover
and open.
2) Insert the 9V battery into the battery
compartment.
3) Make sure you are installing the battery properly. Be sure to
match the positive and negative ends of the battery to the
marking in the battery compartment of the device.
4) Press and pull down following the direction of the arrow
indicated on the photo.
5) Replacing the battery compartment cover and press to close
6) If replacing the battery, you should slide the battery compartment
cover and open. Pull up the battery following the direction of
the arrow indicated on the photo. And insert the 9V battery
according to the above steps 2 - 5.
Caution:
Always use the electrodes with the
requirements of the IEC/EN60601-1,ISO10993-1/-5/-10 and
IEC/ EN60601-1-2, such as with CE mark, or which are legally
marketed in the US under 510(K) listing.
Caution:
Do not insert the plug of the patient
lead wire into any AC power supply
socket.
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4.4 Electrode
Caution:
1) Before applying the self-adhesive electrodes, it is
recommended to wash and degrease and dry the skin.
2) Do not turn on the device when the self-adhesive
electrodes are not positioned on the body.
3) Never remove the self-adhesive electrodes from the skin
while the device is turned on.
4) It is recommended that, at minimum, 1.5” x 1.5” self-
adhering based, square electrodes are used at the
treatment area
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4.4.3 Electrode placement
4.5 Turn on
Caution:
Consult your physician for your suitable therapeutic mode
4.7 Steps to Set a New Program
3) Set Timer
Press [S] button cycle to enter this setting. The treatment time is
adjustable from 1 to 60 minutes or Continuous. Press [▲] or [▼]
button control to adjust setting. You can set the timer to
“Continuous” mode by pressing the [▲] control when it shows 60
minutes. The output will be shut off when time is up.
27
4.7.2 EMS Setting
Press the [S] button cycle to enter the setting state. The settings
can be adjusted according to the following steps:
2) Set Timer
Press [S] button cycle to enter this setting. The treatment time is
adjustable from 1 to 60 minutes or Continuous. Press [▲] or [▼]
control to adjust setting. You can set the timer to “Continuous”
mode by pressing the [▲] button when it shows 60 minutes. The
output will be shut off when time is up.
Caution:
Contract time does not include the ramp up and ramp down
time, ON time=Ramp up + Contract time + Ramp down.
4.7.3 IF Setting
Press the [S] button to enter the setting state. The settings can be
adjusted according to the following steps:
2) Set Timer
Press [S] button cycle to enter this setting.The treatment time is
adjustable from 1 to 60 minutes or Continuous.
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Press [▲] or [▼] control to adjust setting. You can set the timer to
“Continuous” mode by pressing the [▲] button when it shows 60
minutes. Its output will be shut off when time is up.
2) Set Timer
Press [S] button cycle to enter this setting. The treatment time is
adjustable from 1 to 60 minutes or Continuous. Press [▲] or [▼]
button control to adjust setting. You can set the timer to
“Continuous” mode by pressing the [▲] control when it shows 60
minutes. Its output will be shut off when time is up.
Press the intensity control button ([▲] and [▼]) to control the
intensity output. Slowly press the intensity button control until you
reach the setting recommended by your physician or therapist.
Repeat for the other channel, if both channels are to be used.
Caution:
1) If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a
comfortable level and contact your medical practitioner
if problems persist.
2) TENS, EMS and IF therapeutic mode. If the electrodes are
not placed firmly on skin or the device is not connected to
the electrodes and the stimulator’s output intensity
surpasses 12mA, the intensity will automatically reset to
0mA.
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4.10. Stop the treatment
When you have activated the treatment timer,you can press the [M]
button or the [▼] button to control stop the treatment.
Caution:
Default state, if the button is locked, you can press only one of
the [▼] buttons to unlock, and then press the [M] button or the
[▼] button to control stop the treatment.
Caution:
1) If there is no operation in the panel for 2 minutes in the
waiting state, the device turns off automatically.
2) In shutdown state, keep pressing the channel 2 [▼] first,
and then press [ ] button at the same to restore factory
parameter settings
When the low power indicator flashes, the device will be turns off
automatically, the battery should be replaced with a new one as
soon as possible. However, the unit may continue to operate for an
extended period of time depending on the setting and intensity
level.
5. Program
50-300us 1-60min,continuous
TENS 1-150Hz 50-300us 1-60min,continuous
33
3) Wipe the area with the skin preparation your clinician has
recommended. Let this dry. Apply electrodes as directed.
4) Many skin problems arise from the “pulling stress” from
adhesive patches that are excessively stretched across the skin
during application. To prevent this, apply electrodes from center
outward; avoid stretching over the skin.
5) To minimize “pulling stress”, tape extra lengths of lead wires to
the skin in a loop to prevent tugging on electrodes.
6) When removing electrodes, always remove by pulling in the
direction of hair growth.
7) It may be helpful to rub skin lotion on electrode placement area
when not wearing electrodes.
8) Never apply electrodes over irritated or broken skin.
1) Remove the battery from the device every time when you clean
the device.
2) Clean the device after use with a soft, slight moistened cloth.
In case of more extreme soiling you can also moisten the
cloth with mild soapy water.
3) Do not use any chemical cleaners or abrasive agents for
cleaning.
6.3 Electrodes
1) Use the device only with the leads and electrodes provided by
the manufacturer. Use only the electrode placements and
stimulation settings prescribed by your physician or therapist.
2) It is recommended that, at minimum, 1.5” x 1.5” self-adhering
electrodes should be used at the treatment area.
3) Inspect your electrodes before every use. Replace electrodes
as needed. Reusable electrodes may cause slight skin irritation,
lose adhesion properties and deliver less stimulation if
overused.
34
To use these electrodes:
1) Lift the corner of the electrode and gently remove it from the
skin.
2) It may be helpful to improve repeated application by
spreading a few drops of cold water over the adhesive and
turn the surface up to air dry. Over Saturation with water
will reduce the adhesive properties.
3) Between uses, store the electrodes in the resealable bag in a
cool dry place.
Caution:
1) Do not pull on the electrode wire. Doing so may damage
the wire and electrode.
2) Do not apply to broken skin.
3) The electrodes should be discarded when they are no
longer adhering.
4) The electrodes are intended for single patient use only.
5) If irritation occurs, discontinue use and consult your
clinician.
6) Read the instructions for use of self-adhesive electrodes
before application.
35
7) Always use the electrodes with the requirements of the
IEC/EN60601-1, ISO10993-1/-5/-10 and IEC/ EN60601-1-2,
such as with CE mark, or are legally marketed in the US
under 510(K) procedure.
Clean the electrode cords by wiping them with a damp cloth. Coating
them lightly with talcum powder will reduce tangles and prolong the
life.
6.5 Maintenance
37
8. Storage
9. Disposal
38
10. Electromagnetic Compatibility (EMC) Tables
39
Guidance and manufactu
m urer’s decllaration. Electromag
E gnetic immmunity
The de
evice is inte
ended for use in the electromagnetic envvironment sspecified below.
b
The cu
ustomer or the
Immunnity IEC 60501
6 Commpliance Electroma
agnetic environment - guidance
e
test test le
evel Levvel
Portable and
a mobile e RF comm munications
equipmen nt should be
b used no o closer to any
part of the
e device, in
ncluding ca ables, thann the
recomme ended sepa aration disttance calcu ulated
from the equation
e a
applicable tto the frequ
uency
of the tran
nsmitter.
Recomme ended sep paration disstance.
Conduucted 3 Vrm
ms 3 Vrrms
RF lEC
C 150 kHz
k to
61000--4-6 80 MHHz
Radiatted 3 V/mm80 3 V//m 800MHz to 2,5MHz
RF lEC MHz to
t t
61000--4-3 2.5 GHz
80MHz to 800MHz
NOTTE I At 80 MHz
M ends 800 MHz. the higherr frequencyy range applies.
NOTTE 2 These e guideliness may not apply in alll situationss. Electrom
magnetic
propa
agation is affected byy absorptio
on and reflection from m structurees, objects
and people.
p
1. Field
d strengthss from fixed transmittters, such as base sttations for radio
(cellu
ular/cordlesss) telepho ones
and land
l mobile radios, amateur
a radio, AM annd FM radio broadcast and TV
broad dcast cann not be pred dicted theo w accuraccy. To assess the
oretically with
electtromagnetic environm ment due to o fixed RF transmitte ers, an elecctromagnetic site
surve ey should beb conside ered. If the measured d field stren
ngth in the location in
n which
the device
d is ussed exceed ds the appplicable RFF compliancce level ab bove, should be
obse erved to verify
normmal operatio on. If abnoormal perfoormance is observed, additiona al measures may
be ne ecessary, such
s as re
eorienting or
o relocatin
ng the device.
2. Oveer the frequuency rang ge 150 kHzz to 80 MHz, field stre engths sho ould be less than
[Vi] V/m.
V
40
Recomm mended se eparation distances
d b
between
portable and mobille RF communication ns equipme ent and thee device
The device
d is intended forr use in an electromaagnetic envvironment iin which ra
adiated
RF dissturbancess are contrrolled. The customer or the useer of the de
evice can help
h
prevent electrommagnetic innterferencee by maintaaining a minimum disstance betw ween
portab
ble and mo obile RF coommunicattions equip pment (trannsmitters) a
and the ass
recom
mmended below,
b acco ording to the maximuum output power of th he
commmunicationss equipmen nt.
Rate
ed maximum Separattion distanc
ce according to frequ
uency of
outtput powerr transmitter
t r
of tra
ansmitter 15
50 kHz to 8 MHz
M to 800
0 800 M
MHz to 2,5 GHz
MHHz MH
Hz
W
0,0
01 0.12 0.12
0 0.23
0,,1 0.38 0.38 0.73
1 1.2 1.2 2.3
100 3.8 3.8 7.3
10
00 12 12 23
For tran
nsmitters raated at a maximum
m o
output pow
wer not liste
ed above, tthe
recomm mended separation distance d in meters (m) can be estimated d using the
equation applicab ble to the frrequency of o the trans
smitter, where P is th he maximum
output power
p ratin
ng of the trransmitter in watts (WW) accordaable to the transmitterr
manufa acturer.
NOTE I At 80 MHz and 800 MHz. the separation n distance for the higher freque ency
range applies.
a NOOTE 2 These guidelin nes may noot apply in all situatio
ons.
Electrommagnetic propagatio
p n is affecte
ed by
absorpttion and reeflection fro
om structurres, objects and peop ple.
ossary of Symbols
11. Glo S
Batch code……..0
c 01000001
Serial number……
n …50000001
Attentio
on: Read th
he operatin
ng instruction for use!
Electricaal devices are recyclable material and sh hould not be
disposeed of with household
h waste afteer their use
eful life! He
elp us
to prote
ect the enviironment and
a save re esources a and take thhis
device to
t the apprropriate collection pooints. Pleasse contact the
organizaation whichh is respon
nsible for waste
w dispo
osal in youur area
if you ha
ave any qu uestions.
42
Manufactured for:
Current Solutions LLC
TM