6300.

ai 1 2011/11/25 下午 06:09:13

INSTRUCTION MANUAL
FOR THE
Premier Combo Plus
DIGITAL TENS/EMS

CM

MY

CY

CMY

Distributed by:

0434
V1.0
 INDEX
Chapter Contents
1. General Description ................................................2
2. Introduction .............................................................2
3. Cautions ...................................................................4
4. Warnings ..................................................................6
5. Contraindications ....................................................6
6. Adverse Reactions ..................................................6
7. Construction ............................................................7
8. Technical Specifications.........................................9
9. Replacement Parts ..................................................15
10. Accessories .............................................................15
11. Graphic Symbols .....................................................16
12. Operating Instructions ............................................16
13. Parameter Controls .................................................17
14. Attachment of Electrode Lead Wires.....................20
15. Lead Wire Maintenance ..........................................21
16. Electrode Options ...................................................21
17. Electrode Placement ...............................................21
18. Tips for Skin Care....................................................22
19. Application of Reusable self adhesive
electrodes ................................................................22
20. Adjusting the Controls............................................24
21. Battery Information ................................................32
22. Maintenance, Transportation, and Storage ..........34
23. Safety-Technical Controls ......................................34
24. Malfunctions ...........................................................35
25. Conformity to Safety Standards ............................35
26. Warranty ...................................................................36
Manufacturer............................................................36
Representative in the EU ........................................36
27. Appendix ..................................................................37

1
 Chapter 1: GENERAL DESCRIPTION HOW TENS WORKS
There is nothing “magic” about Transcutaneous Electrical Nerve
The Premier Combo Plus TENS/EMS is a fully digital battery oper- Stimulation (TENS). TENS is intended to be used to relieve pain.
ated pulse generator that sends electrical impulses to the nerves The TENS unit sends comfortable impulses through the skin that
and underlying muscle groups. This unit is a combination stimulator stimulate the nerve (or nerves) in the treatment area. In many cas-
of TENS and EMS which can be used for pain relief and muscle es, this stimulation will greatly reduce or eliminate the pain sensa-
stimulation. The device is provided with two controllable output tion the patient feels. Pain relief varies by individual patient, mode
channels, each independent of the other. A pair of electrodes can selected for therapy, and the type of pain. In many patients, the
be connected to each output channel. The intensity level and set- reduction or elimination of pain lasts longer than the actual period of
tings are controlled by press buttons stimulation (sometimes as much as three to four times longer). In
others, pain is only modified while stimulation actually occurs. You
Chapter 2 : INTRODUCTION may discuss this with your physician or therapist.
EXPLANATION OF EMS
EXPLANATION OF PAIN
Electrical Muscle Stimulation is an accepted and proven way of
Pain is a warning system and the body’s method of telling us that treating muscular injuries. It works by sending electronic pulses to
something is wrong. Pain is important; without it abnormal condi- the muscle needing treatment; this causes the muscle to contract.
tions may go undetected, causing damage or injury to vital parts of It is derived from the square waveform, originally invented by John
our bodies. Faraday in 1831. It works by directly stimulating motor neurons
Even though pain is a necessary warning signal of trauma or mal- which causes muscle contraction. It is widely used in hospitals and
function in the body, nature may have gone too far in its design. sports clinics for the treatment of muscular injuries and for the re-
education of paralyzed muscles, to prevent atrophy in affected mus-
Aside from its value in diagnosis, long-lasting persistent pain serves
cles and improve muscle tone and blood circulation.
no useful purpose. Pain does not begin until coded messages
travel to the brain where they are decoded, analyzed, and reacted HOW EMS WORKS
to. The pain message travels from the injured area along the small
1. Relaxation of muscle spasms
nerves leading to the spinal cord. Here the message is switched to 2. Prevention or retardation of disuse atrophy
different nerves that travel up the spinal cord to the brain. The pain 3. Increasing local blood circulation
message is interpreted and pain is perceived. 4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent
EXPLANATION OF TENS
venous thrombosis
Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug- 6. Maintaining or increasing range of motion
free method of controlling pain. TENS uses tiny electrical impulses The EMS units send comfortable impulses through the skin that
sent through the skin to nerves to modify your pain perception. stimulate the nerves in the treatment area. When the muscle re-
TENS does not cure any physiological problem; it only helps control ceives this signal it contracts. As the signal strength increases,
the pain. TENS does not work for everyone; however, in most pa- the muscle contracts as in physical exercise. Then when the pulse
tients it is effective in reducing or eliminating the pain, allowing for a ceases, the muscle relaxes and the cycle starts over again, (Stimu-
return to normal activity. lation, Contraction and Relaxation.) Powered muscle stimulators
2 3
should only be used under medical supervision for adjunctive thera- 9. Turn the TENS off before applying or removing electrodes.
py for the treatment of medical diseases and conditions. 10. Isolated cases of skin irritation may occur at the site of electrode
placement following long term application. If this occurs,
IMPORTANT SAFETY INFORMATION discontinue use and consult your physician.
11. If TENS therapy becomes ineffective or unpleasant, stimulation
Read instruction manual before operation. Be sure to comply with should be discontinued until its use is re-evaluated by a physician
all “CAUTIONS” and “WARNINGS” in the manual. Failure to follow 12. Keep this device out of the reach of children.
instructions can cause harm to user or device. 13. The device has no AP/APG protection.
Do not use it in the presence of explosive atmosphere and
flammable mixture.
Chapter 3 : CAUTIONS
EMS
TENS 1. Federal law (USA) restricts this device to sale by or on the
1. Federal law (USA) restricts this device to sale by or on the order of a physician
order of a physician. 2. Safety of powered muscle stimulators for use during pregnancy
2. Do not use this device for undiagnosed pain syndromes until has not been established.
consulting a physician. 3. Caution should be used for patients with suspected or diagnosed
3. Patients with an implanted electronic device, such as a cardiac heart problems.
pacemaker, implanted defibrillator, or any other metallic or 4. Caution should be used for patients with suspected or diagnosed
electronic device should not undergo TENS treatment without epilepsy.
first consulting a doctor. 5.  Caution should be used in the presence of the following:
4. Patients with heart disease, epilepsy, cancer or any other health a. When there is a tendency to hemorrhage following acute
condition should not undergo TENS treatment without first trauma or fracture;
consulting a physician. b. Following recent surgical procedures when muscle
5. Stimulation delivered by this device may be sufficient to cause contraction may disrupt the healing process;
electrocution. Electrical current of this magnitude must not flow c. Over the menstruating or pregnant uterus; and
through the thorax or across the chest because it may cause a d. Over areas of the skin which lack normal sensation.
cardiac arrhythmia. 6. Some patients may experience skin irritation or hypersensitivity
6. Do not place electrodes on the front of the throat as spasm of due to the electrical stimulation or electrical conductive medium.
the Laryngeal and Pharyngeal muscle may occur. Stimulation The irritation can usually be reduced by using an alternate
over the carotid sinus (neck region) may close the airways, conductive medium, or alternate electrode placement.
make breathing difficult, and may have adverse effects on the 7. Electrode placement and stimulation settings should be based
heart rhythm or blood pressure. on the guidance of the prescribing practitioner.
7. Do not place electrodes on your head or at any sites that may 8. Powered muscle stimulators should be kept out of the reach of
cause the electrical current to flow transcerebrally (through the children.
head). 9. Powered muscle stimulators should be used only with the leads
8. This device should not be used while driving, operating and electrodes recommended for use by the manufacturer.
machinery, close to water, or during any activity in which 10. Portable powered muscle stimulators should not be used while
involuntary muscle contractions may put the user at undue risk driving, operating machinery, or during any activity in which
of injury. involuntary muscle contractions may put the user at undue risk
of injury.
4 5
 Chapter 4 : WARNINGS Chapter 7 : CONSTRUCTION

1. The long-term effects of chronic electrical stimulation are

unknown.
2.  Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid
sinus reflex.
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 strong enough to close the airway or
cause difficulty in breathing.
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.
6. Stimulation should not be applied over swollen, infected, or
inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,
varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to,
cancerous lesions.
   

Chapter 5: CONTRAINDICATION

Electrical stimulators should not be used on patients with cardiac

demand pacemakers. FRONT
(1) LEAD CONNECTOR
(2) ON/OFF/PAUSE CONTROL
Chapter 6: ADVERSE REACTIONS (3) LIQUID CRYSTAL DISPLAY
(4) MODE CONTROL
(5) SET CONTROL
On rare occasions skin irritation and burns beneath the electrodes
(6) SETTING INCREMENT CONTROL
have been reported with the use of electrical stimulators. If irritation
(7) SETTING DECREMENT CONTROL
occurs, discontinue use and consult your physician.
(8) INTENSITY INCREMENT CONTROL
(9) INTENSITY DECREMENT CONTROL

6 7
 BACK SIDE Chapter 8 : TECHNICAL SPECIFICATIONS

The technical specification details of Premier Combo Plus Digital

TENS/EMS are as follows:
MECHANISM TECHNICAL DESCRIPTION
01 Channel Dual, isolated between channels
02 Pulse Amplitude Adjustable, 0-100 mA peak into 500 ohm
load each channel.
03 Wave Form Asymmetrical Bi-Phasic Square Pulse
04 Voltage 0 to 50V (Load: 500 ohm)
05 Power source One 9 Volt Battery.
06 Size 11.8cm(L) x 6 cm(W) x 3.1cm(H)
07 Weight 157 grams with battery.
08 Pulse Rate Adjustable, from 2 to 150 Hz, 1 Hz/step
09 Pulse Width Adjustable, from 50 to 300 microseconds,
10 µs/step
10 On Time Adjustable, 2~90 seconds , 1 Sec./ step
11 Off Time Adjustable, 2~90 seconds , 1 Sec./ step
12 Ramp Time Adjustable, 1~8 seconds, 1 Sec./ step, The
BACK “On” time will increase and decrease in
(10) BELT CLIP the setting value.
(11) BATTERY STRIP 13 Mode Six TENS Modes: B(Burst), N(Normal),M
(Modulation Rate & Width),S1( Modulation
(12) BATTERY CASE
Width), S2 (Modulation Width) and P
Three EMS Modes:C(Constant), S
SIDE (Synchronous), A(Alternate)
(13) KEY LOCK FACILITY 14 Burst Mode Burst rate: Adjustable, 0.5 – 5Hz
Pulse width adjustable, 50~300µs
Frequency fixed = 100 Hz
Liquid Crystal Display 15 Normal Mode The pulse rate and pulse width are
1. INTENSITY LEVEL adjustable. It generates continuous
2. MODE stimulation based on the setting value.
16 Modulation Mode Modulation mode is a combination of pulse
3. SETTINGS rate and pulse width modulation. The pulse
4. STIMULATION TYPE rate and width are automatically varied in
5. LOW BATTERY INDICATOR a cycle pattern. The pulse width is
decreased by 50% from its original setting
6. LOCK
8 9
 in 0.5 second, then the pulse rate is time. The OFF Time should be equal to or
decreased by 50% from its original setting greater than the ON Time.
in 0.5 second. Total cycle time is 1 second. ON TIME ≥Ramp up + Ramp down
In this mode, pulse rate(2-150Hz) and OFF TIME ≥ON TIME
pulse width(50-300µs) are fully adjustable. 22 Mode P The pre-set parameters of the 24
17 S1 Mode Pulse width is automatically varied in a programs are as given below:
cyclic pattern over a nominal 10 second
period. Pulse width decreases over a Program The pre-set parameters of the TENS 1-12
period of 4 seconds from the initial setting Details programs are as given below:
to a value 40% less.
The narrower pulse width continues for 1 Program Mode Pulse Rate Pulse Width Timer
second. It then increases over a period of P1 Constant 80Hz 180µs Continue
4 seconds to its initial setting. The cycle is P2 Burst 2Hz 180µs Continue
then repeated. Pulse rate and pulse width P3 -70% P.W. 80Hz 70µs -180µs Continue
are fully adjustable. Modulation
18 S2 Mode Pulse width is automatically varied in a P4 Mixed 15Hz in 3 Sec / 180µs Continue
cyclic pattern over a nominal 10 second Frequency 2Hz in 3 Sec
period. Pulse width decreases over a
period of 4 seconds from the initial setting P5 Mixed 80Hz in 3 Sec / 280µs Continue
to a value 70% less. Frequency 2Hz in 3 Sec
The narrower pulse width continues for 1 P6 Constant 10Hz 180µs Continue
second. It then increases over a period of P7 Constant 80Hz 60µs Continue
4 seconds to its initial setting. The cycle is
P8 Constant 10Hz 200µs 30 Minutes
then repeated. Pulse rate and pulse width
are fully adjustable. P9 Burst 50Hz 200µs 30 Minutes
19 Constant The pulse rate and pulse width are P10
Mode(C) adjustable. It generates continuous on Time Pause Time Frequency Pulse Width Sub- Active Pulse
stimulation is delivered . (sec) (sec) (Hz) (µs) Pulse Channels Polarity
20 Synchronous Output from both channels occurs 2 0 5 120 No CH1 & CH2 Positive
Mode(S) synchronously. The "ON" time includes 1.5 0 8 120 No CH1 & CH2 Positive
"Ramp Up" and "Ramp Down" time. 1.4 0 10 120 No CH1 & CH2 Positive
Therefore, the setting of ON Time should 1 0 15 120 No CH1 & CH2 Positive
be no less than two times of the "Ramp" 0.8 0 20 120 No CH1 & CH2 Positive
time in this mode. 0.7 0 30 120 No CH1 & CH2 Positive
21 Alternate The stimulation of the CH2 will occur after 0.7 0 40 120 No CH1 & CH2 Positive
Mode(A) the 1st contraction of CH1 is completed. In 0.7 0 50 120 No CH1 & CH2 Positive
this mode, the setting of ON Time should 1 0 75 120 No CH1 & CH2 Positive
be no less than two times of the "Ramp"

10 11
 0.7 0 100 120 No CH1 & CH2 Positive P20 Muscle training SYN 50 250 2 10 10 20
1 0 125 120 No CH1 & CH2 Positive
1 0 125 120 No CH1 & CH2 Positive P21 Muscle training SYN 50 250 2 14 14 20
0.7 0 100 120 No CH1 & CH2 Positive P22 Muscle training SYN 35 400 2 10 10 20
1 0 75 120 No CH1 & CH2 Positive
P23 Muscle training ALT 50 250 2 10 10 20
0.7 0 50 120 No CH1 & CH2 Positive
0.7 0 40 120 No CH1 & CH2 Positive P24 Muscle training ALT 50 250 2 10 14 20
0.7 0 30 120 No CH1 & CH2 Positive
0.8 0 20 120 No CH1 & CH2 Positive 23Timer Adjustable, from 5 to 60 minutes minutes
1 0 15 120 No CH1 & CH2 Positive and continue(C), 5 minutes each step
1.4 0 10 120 No CH1 & CH2 Positive
24 Patient This unit can store 60 sets of operation
1.5 0 8 120 No CH1 & CH2 Positive
Compliance Meter records. Total recorded time is 999 hours.
P11 Modulation 2-100Hz 260µs-150µs Continue
25 Low Battery A low battery indicator will show up when
Rate & width
over 6 seconds Indicator the battery is low.
P12 Modulation 80< - >7Hz 260µs Continue 26 Operating Temperature:0°~40°C
Rate & width Condition Relative Humidity: 30%~75%
over 6 seconds Atmosphere Pressure : 700Hpa~1060Hpa
27 Remark There may be up to a +/-10% tolerance of
Program The pre-set parameters of the EMS 13-12
all parameters and +/-20% tolerance of
Details programs are as given below:
output amplitude & voltage.
Mode SYN/ Rate Width Ramp ON Time Off Time Timer
ALT (Hz) (µs) (sec) (sec) (sec) (sec)
P13 ACL repair/joint SYN 35 300 3 8 24 20
protection back muscle
P14 Spasm small SYN 80 300 3 10 5 20
muscle
P15 Spasm SYN 80 250 2 8 4 20
Postoperative
P16 Arthroscopy SYN 25 200 2 6 30 15

P17 Disuse atrophy SYN 35 300 2 5 15 30

P18 Shoulder SYN 50 300 5 15 50 15

Subluxation
P19 Range of motion SYN 40 250 3 6 21 30
muscle re-education of hips

12 13
The waveforms of the TENS modes are as follows. Chapter 9 : REPLACEABLE PARTS
1. Burst
The replaceable parts and accessories of Premier Combo Plus
DIGITAL TENS/EMS devices are as given below - Except leads,
electrodes, battery and battery case cover, please do not try to re-
place the other parts of a device.

2. Normal PARTS
01 LEAD WIRES
02 ELECTRODES
03 9V BATTERY ,TYPE 6F22
04 BELT CLIP
3. Modulation 05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAIN PCB
08 INTENSITY KNOB

4. S1 (Strength-Duration) Chapter 10 : ACCESSORIES

Each Premier Combo Plus Digital TENS/EMS comes complete with

standard accessories and the standard labels as given below:

I. Accessories
REF. NO. DESCRIPTION Q’TY
5. S2 (Strength-Duration) 1. SP4040 40 X 40 mm Adhesive Electrodes 4 pieces
2. KE-24 Electrodes Leads 2 pieces
3. GC-01 9 V Battery, type 6F22 1 piece
4. Instruction Manual 1 piece
5. Carrying Case 1 piece

14 15
II. LABEL their corresponding terminals in the device. Make sure that the
The label attached to the back of device con- unit is turned off.
tains important information about this device- 2) Insert the lead wires into the lead wire sockets on top of the
model, supply voltage, CE number and cau- device.
tion. Please do not remove. 3) Open the electrode package. Then insert each lead wire pin
into the pig tail of the electrodes
4) Place the electrode on your body as
directed by your physician.
Chapter 11 : GRAPHIC SYMBOLS 5) Turn on the power by pressing the
power On/Off/Pause button.
1. Degree of Electrical Protection BF 6) Select the mode and settings as
directed by your physician.
2. Do not insert the plug into AC power supply socket. 7) Slowly increase or decrease the
3. Timer intensity by pressing the intensity
control buttons.
4. Increment 8) You may press the On/Off/Pause
button if you want to stop treatment
5. Decrement for a while.
7. Consult Instructions for use 9) After treatment, turn the device off
by pressing the On/Off/Pause button.
8. Manufacturer
9. Serial Number
Chapter 13 : PARAMETER CONTROLS
10. Lock
11. Low Battery PULSE DURATION

12. Pause Wider pulse duration settings will deliver stronger stimulation for
any given intensity setting. As mentioned in the Controls section, by
13. DC Current(DC Power source) using a combination of intensity and pulse duration different nerve
fibres are stimulated.
14. Comply with MDD 93/42/EEC requirements as amended
by 2007/47/EC. Notify body Det Norske Veritas(DNV). The wider pulse duration is needed to recruit motor fibres, whereas
15. Power the narrow pulse duration is used on the more sensory fibres. The
choice of which pulse duration to use is partially dependent upon
the Treatment Mode and Protocol selected.
Chapter 12: OPERATING INSTRUCTIONS PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends great-
1) Insert the 9V battery into the device's battery compartment. ly upon the type of electrode placement given to the patient.
Make sure that the plastic seal on the 9V battery is removed.
Line up the positive and negative terminals on the battery with When using contiguous and dermatome electrode placements (i.e.

16 17
stimulating directly through the area of pain or localized innnerva- higher pulse rates there will simply be increased muscle tension.
tion), a higher pulse rate (setting greater than 80Hz on the Pulse Strong muscular contraction is typically not used in TENS therapy.
Rate Control) is required. The patient should not perceive individual
However, muscular contraction may be useful if the pain involves a
pulses but rather have the sensation of steady continuous stimulation.
cramped or spastic muscle. The TENS can be used as a traditional
When using point treatments, it has been suggested that lower muscle stimulator in the circumstances to quickly break the spasm.
pulse rates be utilized (less than 10Hz). With this setting the patient Use a higher pulse rate, wide pulse duration and set the intensity
should be able to perceive individual pulses. to visible contraction (still within patient tolerance). Twenty or thirty
When using multiple electrode placement strategies, such as com- minutes of such a tetanized muscular contraction will generally
binations of point and contiguous electrode placements, the higher break the spasm. In all cases, if the patient complains that the stim-
pulse rates are suggested. ulation is uncomfortable, reduce intensity and/or cease stimulation.
Despite the above recommendations, individual patients may re-
quire slight variations of the above settings, according to the nature TIME DURATION
of their condition.
The onset of pain relief should occur shortly after the intensity set-
TREATMENT MODE ting has been determined. However, in some cases, pain relief may
take as long as 30 minutes to achieve, especially when using point
Normal or Conventional TENS offers the practitioners complete con- electrode placements and slow pulse rates.
trol over all the various treatment parameters of the instrument.
TENS units are typically operated for long periods of time, with a
Burst Mode is analogous to the Low Rate TENS technique except minimum of 20 ~ 30 minutes and in some post-operation protocols,
the low frequency individual pulses are replaced by individual “bursts” as long as 36 hours.
of 7-10 individual pulses. It is thus a combination of Conventional
In general, pain relief will diminish within 30 minutes of the ces-
TENS and Low Rate TENS. In Burst Mode, the treatment frequency
sation of stimulation. Pain relief obtained through point electrode
is adjustable at the range between 0.5Hz ~ 5Hz.
placements may last longer (perhaps because of the presence of
Modulated Mode attempts to minimise nerve accommodation by endorphins).
continuously cycling the treatment intensity. Advise the patient to
increase the intensity very slowly when using modulation mode.
CONTRACTION / RELAXATION
INTENSITY
The contraction time and relaxation time of EMS is adjustable.
Each patient responds differently to different levels of intensity, due Stimulation will commence at the contraction setting time and cease
to varying degrees of tissue resistance, enervation, skin thickness, at the relaxation setting time. Then the cycle starts over again -
etc. Intensity instructions are therefore limited to the following set- Stimulation, Contraction and Relaxation.
tings: RAMP
Perception – The intensity is increased so that the patient can feel
In order to achieve a comfortable exercise and avoid discomfort be-
the stimulation, but there is not any muscular contraction.
cause of immediate current onset, each contraction may be ramped
Slight Contraction – Intensity is increased to a barely visible muscu- so that the signal comes on gradually and smoothly. The intensity of
lar contraction that is not strong enough to move a joint. When us- electrical current will reach the set level within the Ramp time. It will
ing low pulse rate settings, this will show as individual twitches. At
18 19
NOT reach the desired level if the ramp time is greater than the total CAUTION
contraction time.
Do not insert the plug of the patient lead wire into any AC power
OUTPUT MODE supply socket.
Chapter 15: LEAD WIRE MAINTENANCE
The output of both channels are adjustable. Stimulation can be
synchronous or alternate. Stimulation of both channels will occur at
Clean the wires by wiping with a damp cloth. Coating them lightly
the same time when synchronus pattern is selected. In alternating
with talcum powder will reduce tangling and prolong life.
mode, the stimulation from CH2 will occur after contraction of Ch1 is
finished.

Chapter 16 : ELECTRODE OPTIONS

Chapter 14 : ATTACHMENT OF ELECTRODE
The electrodes are disposable and should be routinely replaced
LEAD WIRES when they start to lose their adhesive nature. If you are unsure of
your electrode adhesive properties, order replacement electrodes.
The wires provided with the system insert into the jack sockets Replacement electrodes should be re-ordered through or on the
located on top of the device. Holding the insulated portion of the advice of your physician to ensure proper quality. Follow application
connector, push the plug end of the wire into one of the jacks (see procedures outlined in electrode packing, to maintain optimal stimu-
drawing); one or two sets of wires may be used. lation and to prevent skin irritation.

Chapter 17: ELECTRODE PLACEMENT

The placement of electrodes can be one of the most important

parameters in achieving success with TENS or EMS therapy. It
is important that the physician experiments to determine optimum
electrode placement.

Every patient responds to electrical stimulation differently and their

needs may vary from the conventional settings suggested here. If
the initial results are not positive, speak to your physician about al-
ternative stimulation settings and/or electrode placements. Once an
After connecting the wires to the stimulator, attach each wire to an acceptable placement has been achieved, mark the electrode sites
electrode. Use care when you plug and unplug the wires. Jerking and the settings, so that effective treatment may effectively continue
the wire instead of holding the insulated connector body may cause at home.
wire breakage.

20 21
 Chapter 18: TIPS FOR SKIN CARE Removal

1. Turn off the unit prior to removing the electrodes.

To avoid skin irritation, especially if you have sensitive skin, follow 2. Lift at the edge of electrodes and peel; do not pull on the lead
these suggestions: wires because it may damage the electrodes.
1. Wash the area of skin where you will be placing the electrodes, 3. Place the electrodes on the liner and remove the lead wire by
using mild soap and water before applying electrodes, and after twisting and pulling at the same time.
taking them off. Be sure to rinse soap off thoroughly and dry
skin well.
2. Excess hair may be clipped with scissors; do not shave
stimulation area.
3. Wipe the area with the skin preparation your physician 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 Care and Storage
outward; avoid stretching over the skin.
1. Between uses, store the electrodes in the resealable bag in a
5. To minimize “pulling stress”, tape extra lengths of lead wires to
cool dry place.
the skin in a loop to prevent tugging on electrodes.
2 . It may be helpful to improve repeated application by spreading a
6. When removing electrodes, always remove by pulling in the
few drops of cold water over the adhesive and turn the surface
direction of hair growth.
up to air dry. Over Saturation with water will reduce the adhesive
7. It may be helpful to rub skin lotion on electrode placement area
properties.
when not wearing electrodes.
8. Never apply electrodes over irritated or broken skin.
Important

Chapter 19: APPLICATION OF RE-USABLE SELF 1. Do not apply to broken skin.

2. The electrodes should be discarded and re-ordered from your
ADHESIVE ELECTRODES physician when they are no longer adhering.
3. The electrodes are intended for single patient use only.
Application 4. If irritation occurs, discontinue use and consult your physician.
1. Clean and dry the skin at the prescribed area thoroughly with 5. Read the instructions for use of self-adhesive electrodes before
soap and water prior to application of electrodes. application.
2. Insert the lead wire into the pin connector on the pre-wired
electrodes.
3. Remove the electrodes from the protective liner and apply the
electrodes firmly to the treatment site. Make sure that the unit is
turned off prior to applying the electrodes.
22 23
 Chapter 20 : ADJUSTING THE CONTROLS 3 Mode Control
There are 5 TENS modes(B, N, M, S1, S2) and 3 EMS modes
1. Power On/Off/Pause Button (C, S, A) available. The mode is selected by pressing the “Mode”
control. When a TENS mode is selected, the LCD shows
The power of unit can be turned on by pressing the On/Off/ "TENS". When EMS mode is selected, the LCD shows "EMS"
Pause button. You may start to adjust the settings when the
liquid crystal is light up. Press and hold for 2 seconds to switch
off. To pause stimulation press the button once. To resume
stimulation press the button again and stimulation will be restored
in 2 seconds.
If the unit is not used (buttons not pressed or output level at 0)
for 5 minutes, the power will be shut off automatically.

Pause 4. Set Control

By pressing the "Set" control you select the
setting you intend to adjust. The value is set
by pressing the "Increment" or "Decrement"
controls when the "Set" value is flashing.

5. Increment Control
If the unit is not used(buttons not pressed or output level at 0) for 5 This button controls the increase of settings.
minutes, the power will be shut off automatically
6. Decrement Control
2. Lead Connector
This button controls the decrease of settings.
Connection of the electrodes is made with the two-lead connector
(lead wires) on the top of unit. The device must be turned off 7. Intensity Increase Control
before connecting
the cables. The intensity level can be increased by pressing this button.
Electrodes must be in There are 99 steps of intensity adjustment control. Press the
firm contact button until the desired intensity level is reached.
with the skin. 8. Intensity Decrease Control

The intensity level can be decreased by pressing this button.

There are 99 steps of intensity adjustment control. Press the
button until the desired intensity level is reached.
9. Key Lock Facility
Pressing the "Lock" buttons prevents the settings
24 25
 being changed but the output may be stopped by c. Set Pulse Width
pressing the "On/Off/Pause". Pulse Width is adjustable from 50 µs to 300 µs. Press “SET”
control to enter this menu, then press “ ” or “ “
10. Steps to Set a TENS Program to adjust the setting. If no instructions regarding the pulse
The settings can be adjusted as follows width are given in therapy, set the control to the suggested
70-120 µs setting.
a. Turn on the Power
After the electrodes are placed firmly on skin and
the lead wires are plugged in the socket of device,
turn the unit on by pressing the On/Off/Pause
button. The settings will be displayed on the LCD
screen.

b. Select a Mode d. Set Pulse Rate
Select a mode by pressing the "Mode" control. Pulse rate is adjustable from 2Hz to 150 Hz . Press "SET"
The mode you selected will show up on the top of liquid control to enter this menu, then press " " or " "
crystal display. There are 5 modes of your option including - to adjust the setting. Unless otherwise instructed, set the
B(Burst), M(Normal), M(Modulation), S1, S2 and P. When a pulse rate l to the 70-120 Hz range.
TENS mode is selected, it shows "TENS" on the liquid crystal
display.

e. Set Timer
The treatment time is adjustable between 5 - 60 minutes and
After a mode is selected, always press "Set" to enter next Continue(C). Press "SET" control to enter this menu, then
setting, and press " " or " " to adjust its value. press " " or " " to adjust the setting. The liquid
The settings will be stored immediately after selected. crystal will show the balance treatment time after the
There are 12 preset programs of your option on P mode. stimulation is started. Output will be terminated when time
is up. Turn off the unit when the output is off.
Press " " or " " to select a program desired

after P mode is selected. These programs are not adjustable. Continuous End of Treatment

26 27
 f. Adjust Intensity setting, and press “ “ or “ “ to adjust its value.
There are 99 steps within the intensity range. Set the desired The settings will be stored immediately after selected.
level by pressing the " " or " " controls. Press the There are 12 preset programs of your option on P mode.
"Lock" button to prevent accidental changes. Press “ “ or “ “ to select a program desired
after P mode is selected. These programs are not adjustable.

11. Steps to Set a EMS Program

c. Set Ramp Time
The settings can be adjusted according to the following steps.
The ramp time controls the time taken to reach maximum and
a. Turn on the Power
the time taken to fall to zero I order to make the contraction
After the electrodes are placed firmly on skin and the lead
more comfortable. The ramp time is adjustable between 1 - 8
wires are plugged in the socket of device, turn the unit on by
seconds.
pressing the On/Off/Pause button. The settings will show
up on LCD for your further adjustment.

b. Select a Mode
Select a mode by pressing the "Mode" control. The mode you
selected will show up on the top of liquid crystal display.
There are 3modes of your option including -
d. Set On Time
C(Constant), S(Synchronous), A(Alternate). When an EMS
The On Time controls the length of stimulation. By pressing
mode is selected, it shows "EMS" on the liquid crystal display.
the "Set" control, the contraction time can be adjusted. Both
After a mode is selected, always press "Set" to enter next
channels' stimulation is cycled on and off by the contraction
setting, and press " " or " " to adjust its value.
and relaxation settings. The range is adjustable from 2
The settings will be stored immediately after selected. seconds to 90 seconds.
The total "ON" time must be at least twice the "Ramp" time

After a mode is selected, always press “Set” to enter next

28 29
 e. Set Off Time h. Set Timer
The Off Time controls the length of relaxation. By pressing The treatment time is adjustable between 5 - 60 minutes and
the "SET" control, the relaxation time can be adjusted. Both Continue(C). Press "SET" control to enter this menu, then
channels' stimulation is cycled on and off by the contraction press "Increment" or "Decrement" to adjust the setting. The
and relaxation settings. The range is adjustable from 2 liquid crystal will show the balance treatment time after the
seconds to 90 seconds. stimulation is started. Output will be terminated when time is
In Alternate mode, the OFF Time should be equal or more than up. Turn off the unit when the output is off.
the ON Time. (OFF TIME ≥ ON TIME)
Continuous End of Treatment

f. Set Pulse Width i. Adjust Intensity

Pulse Width is adjustable from 50 µs to 300 µs. Press "SET" There are 99 steps within the intensity range. Set the desired
control to enter this menu, then press " " or " "

to adjust the setting. If no instructions regarding the pulse level by pressing the " " or " " controls. Press the
width are given in therapy, set the control to the suggested "Lock" button to prevent accidental changes.
70-120 µs setting

g. Set Pulse Rate 12. Compliance Meter

Pulse rate is adjustable from 2Hz to 150 Hz . Press "SET" The individual treatment time and total treatment time can be
control to enter this menu, then press " "or " " checked and deleted by the following steps. Sixty sets of
to adjust the setting. treatment records can be stored. Total recorded time is 999
Unless otherwise instructed, set the pulse rate to the 70- hours.
120 Hz range.
Check & Delete Treatment Record
Press "Mode" control and turn on the power simultaneously.
The LCD will show the individual operation time. Press "Mode"
control to check the accumulated treatment time. The record
can be deleted by pressing the "SET" button for two seconds.

30 31
 RECHARGEABLE BATTERIES(NOT INCLUDED)
Prior to the use of a new unit, the rechargeable battery should be
charged according to the battery manufacturer’s instructions. Be-
fore using the battery charger, read all instructions and cautionary
markings on the battery and in this instruction manual.
Individnal Record Accumulated
After being stored for 60 days or more, the batteries may lose their
charge. After long periods of storage, batteries should be charged
13. Check/Replace the Battery: prior to use.
Over time, in order to ensure the functional safety of TENS/
EMS, changing the battery is necessary. BATTERY CHARGING
1. Make sure that both intensity controls (1) Plug the charger into any working 110 or 220/240v mains
are switched to off
electrical outlet. The use of any attachment not supplied with
position.
the charger may result in the risk of fire, electric shock, or
2. Slide the battery compartment cover
and open. injury to persons.
3. Remove the battery from the (2) Follow the battery manufacturer’s instructions for charging time.
compartment. (3) After the battery manufacturer’s recommended charging time
4. Insert the battery into the has been completed, unplug the charger and remove the battery.
compartment. Note the polarity (4) Batteries should always be stored in a fully charged state.
indicated on the battery and in the To ensure optimum battery performance, follow these guidelines:
compartment. (a) Although overcharging the batteries for up to 24 hours will
5. Replace the battery compartment not damage them, repeated overcharging may decrease
cover and press to close. useful battery life.
(b) Always store batteries in their charged condition. After a
battery has been discharged, recharge it as soon as
possible. If the battery is stored more than 60 days, it may
Chapter 21: BATTERY INFORMATION need to be recharged.
(c) Do not short the terminals of the battery. This will cause the
PRECATIONS battery to get hot and can cause permanent damage. Avoid
1. Remove battery if equipment is not likely to be used for some storing the batteries in your pocket or purse where the
time. terminals may accidentally come into contact with coins,
2. Please recycle the used battery in accordance with domestic keys or any metal objects.
regulation. (d) WARNINGS:
3. Do not throw the used battery into fire. 1. Do not attempt to charge any other types of batteries in
If you use rechargeable batteries, please follow the instructions. your charger, other than rechargeable batteries made
32 33
 for your charger. Other types of batteries may leak or 3. Check the usability of accessories.
burst. - patient cable undamaged.
- electrodes undamaged.
2. Do not incinerate the rechargeable battery as it may
- Battery is not corroded
explode!
Please consult your distributor if there are any problems with device
and accessories.
Chapter 22 : MAINTENANCE, TRANSPORTATION
AND STORAGE
Chapter 24 : MALFUNCTIONS
1. Non-flammable cleaning solution is suitable for cleaning the
device.
Should any malfunctions occur while using the Premier Combo Plus
Note: Do not smoke or work with open lights (for example,
Digital TENS/EMS, check
candles, etc.) when working with flammable liquids.
2. Stains and spots can be removed with a cleaning agent.
3. Do not submerge the device in liquids or expose it to large - whether the parameters are set to the appropriate form of therapy.
amounts of water. Adjust the control correctly.
4. Return the device to the carrying box with sponge foam to - whether the cable is correctly connected to the device. The
ensure that the unit is well-protected before transportation. cables should be inserted completely into the sockets.
5. If the device is not to be used for a long period of time, remove - whether the LCD reveals the menu. If necessary, insert a new
the batteries from the battery compartment (acid may leak from battery.
used batteries and damage the device). Put the device and - for possible damage to the cable. Change the cable if any damage
accessories in carrying box and keep it in cool dry place. is detected.
6. The packed TENS device should be stored and transported under
the temperature range of -20°C ~ + 60°C, relative humidity 20% * If there is any other problem, please return the device to your
~95%, atmosphere pressure 500 hPa ~ 1060 hPa. distributor. Do not try to repair a defective device.

Chapter 23: SAFETY-TECHNICAL CONTROLS

Chapter 25: CONFORMITY TO SAFETY
For safety reasons, review the following checklist before using your STANDARDS
Premier Combo Plus DIGITAL TENS/EMS.
1. Check the device for external damage.
- deformation of the housing. The Premier Combo Plus DIGITAL TENS/EMS devices are in com-
- damaged or defective output sockets. pliance with the EN 60601-1-2:2001 and EN 60601-1:1990+A1:199
2. Check the device for defective operating elements. 3+A2:1995+A13:1996 safety standards.
- legibility of inscriptions and labels.
- make sure the inscriptions and labels are not distorted.
34 35