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INDEX
Index
1. General Description ............................................... 2
2. Introduction ............................................................ 2
3. Cautions.................................................................. 8
4. Warnings ................................................................. 10
5. Contraindications .................................................. 11
6. Precaution/Adverse Reactions… ......................... 12
7. Construction… ....................................................... 13
8. TechnicalSpecications ....................................... 15
9. Replaceable Parts .................................................. 24
10. Accessories… ........................................................ 24
11. Graphic Symbols………… ..................................... 26
12. Operating Instructions .......................................... 26
13. Parameter Controls................................................ 35
14. Attachment of Electrode Lead Wires ................... 38
15. Lead Wire Maintenance ......................................... 38
16. Electrode Options .................................................. 38
17. Electrode Placement.............................................. 39
18. Tips for Skin Care .................................................. 39
19. Application of Reusable Self Adhesive
Electrodes............................................................... 40
20. Adjusting the Controls .......................................... 41
21. Battery Information ................................................ 51
22. Maintenance, Transportation, and Storage
of the Device........................................................... 53
23. Safety-Technical Controls ..................................... 54
24. Malfunctions ........................................................... 54
25. Conformity to Safety Standards ........................... 55
26. Warranty/Manufacturer/Representative
in the EU ................................................................. 55
27. Electromagnetic Compatibility Information ........ 57
28. Appendix: Test environment .................................. 61
Chapter Contents Page
32
sent through the skin to nerves to modify pain perception. TENS
does not cure any physiological problem; it 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.
HOW TENS WORKS
There is nothing “magic” about Transcutaneous Electrical Nerve
Stimulation (TENS). TENS is intended to be used to relieve pain.
The TENS unit sends comfortable impulses through the skin that
stimulate the nerve (or nerves) in the treatment area. In many cas-
es, this stimulation will greatly reduce or eliminate the pain sensa-
tion the patient feels. Pain relief varies by individual patient, mode
selected for therapy, and the type of pain. In many patients, the
reduction or elimination of pain lasts longer than the actual period of
stimulation (sometimes as much as three to four times longer). In
others, pain is only modied while stimulation actually occurs. You
may discuss this with your physician or therapist.
EXPLANATION OF EMS
Electrical Muscle Stimulation is an accepted and proven way of
treating muscular injuries. It works by sending electronic pulses to
the muscle needing treatment; this causes the muscle to contract.
It is derived from the square waveform, originally invented by John
Faraday in 1831. It works by directly stimulating motor neurons
which causes muscle contraction. It is widely used in hospitals and
sports clinics for the treatment of muscular injuries and for the re-
education of paralysed muscles, to prevent atrophy in affected
muscles and improve muscle tone and blood circulation.
HOW EMS WORKS
1. Relaxation of muscle spasm
2. Prevention or retardation of disuse atrophy
Chapter 1: GENERAL DESCRIPTION
The ULTRA 9000 Multi-function Combo Stimulator is a fully digital,
battery operated, pulse generator that sends electrical impulses to
the nerves and underlying muscle groups. This unit is a combination
of TENS, EMS, Interferential, Pelvic and Facial stimulator which can
be used for pain relief, muscle stimulation, Incontinence treatment
and facial nerve palsy treatment. The device is provided with two
controllable output channels, each independent of the other. A pair
of electrodes can be connected to each output channel. The inten-
sity level and settings and selection of programs are controlled by
press buttons.
Chapter 2 : INTRODUCTION
EXPLANATION OF PAIN
Pain is a warning system and the body’s method of telling us that
something is wrong. Pain is important; without it abnormal condi-
tions may go undetected, causing damage or injury to vital parts of
our bodies.
Even though pain is a necessary warning signal of trauma or mal-
function in the body, nature may have gone too far in its design.
Aside from its value in diagnosis, long-lasting persistent pain serves
no useful purpose. Pain does not begin until coded messages
travel to the brain where they are decoded, analyzed, and reacted
to. The pain message travels from the injured area along the small
nerves leading to the spinal cord. Here the message is switched to
different nerves that travel up the spinal cord to the brain. The pain
message is interpreted and pain is perceived.
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug-
free method of controlling pain. TENS uses tiny electrical impulses
54
Pelvic Stimulation
Bladder Control for Women
Urinary incontinence is an inability to hold urine and/or faeces until
able to reach a toilet. It is often temporary, and it always results from
an underlying medical condition.
Women experience incontinence twice as often as men. Pregnancy,
childbirth, the menopause and the structure of the female urinary
tract account for this difference. Either sex can become incontinent
due to neurological injury, birth defects, strokes, multiple sclerosis,
and physical problems associated with ageing. The problems are
generally seen to increase with age. It should be noted that inconti-
nence is not inevitable with advancing age.
Incontinence in females often occurs due to problems with the
muscles that help to hold or release urine. The urine is stored in the
bladder until urination occurs.
Incontinence in women usually occurs because of problems with
muscles that help to hold or release urine. The kidneys excrete
the urine which is stored in the bladder. Urine exits from the blad-
der via the urethra. Urination occurs when muscles in the wall of
the bladder contract forcing urine out into the urethra. At the same
time sphincter muscles surrounding the urethra relax, letting urine
pass out of the body. Incontinence may occur when the sphincter
muscles surrounding the urethra become less effective.
Incontinence is treatable and in many cases
may be cured irrespective of age.
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to
prevent venous thrombosis
6. Maintaining or increasing range of motion
The EMS units send comfortable impulses through the skin that
stimulate the nerves in the treatment area. When the muscle re-
ceives this signal it contracts. As the signal strength increases,
the muscle contracts as in physical exercise. Then when the pulse
ceases, the muscle relaxes and the cycle starts over again, (Stimu-
lation, Contraction and Relaxation.) Powered muscle stimulators
should only be used under medical supervision for adjunctive thera-
py for the treatment of medical diseases and conditions.
What is Interferential (IF)?
Interferential uses the principle of interference, hence its name. In-
terferential Therapy devices use two separate electrical frequencies,
which work together to stimulate nerve bres. These frequencies
are able to interfere with the onward transmission of pain signals in
the spinal cord and reduce the degree of pain that is perceived.
How does IF work?
The Interferential stimulator is a dual-channel electronic unit. It in-
corporates a digital display that indicates the operational modes and
the output. It is equipped with an 8-bit microcomputer for controlling
the system. The intensity, duration, frequency and modulation of the
electrical impulses can all be adjusted.
The stimulator uses 4 electrodes producing deeper stimulation when
compared to other types of electrical stimulation. The degree of
pain relief varies from individual to individual and also depends on
the type of pain. The stimulation may reduce the level of perceived
pain or eliminate it altogether. Pain relief may only be felt during the
stimulation period but in many patients the pain relief persists once
the stimulator has been switched off.
76
Facial Nerve Paralysis
Acute
The condition is in the rst 6 weeks of onset. A realistic prognosis
is not always possible at this stage as the degree of nerve dam-
age has not yet been ascertained. Treatment may be initiated and
patients with a neuropraxia will soon undergo a full recovery. Use
the stimulator daily for 1 hour per day. Electrode placements may
need to change on a daily basis to match the changing needs of the
recovering face.
Sub- acute
Paralysis has persisted for 6-12 weeks without full recovery. It is
most likely to be an axonotmesis and nerve regeneration may be
anticipated at a rate of 1mm per day. Treatment may be initiated
at this stage to minimise the complications which occur with nerve
muscle mismatch. Use the stimulator daily for 1 hour the general
order would be:
Risorius/Zygomaticus Major – until mouth is in midline at rest
Risorious/Levator Labii - until movement occurs in cheek
Frontalis & Depressor Labii - prolonged treatment until the face
achieves balance.
Once recovery of forehead and lower lip are achieved further
stimulation may take place to the cheek or lips as required
Chronic (3 – 12 months post-onset)
The principals of treatment as for sub- acute above will be used
from 3-12 months if full recovery is not achieved.
Chronic (1 year+ post-onset)
If after 12 months post-onset, examination of the face still reveals
a degree of denervation, stimulation will result in an improvement
in movement which will become functionally appropriate with use of
exercises.
Long treatments for both the above are required, possibly 3 hours
per day. Stimulation may be through the night whilst asleep. Exer-
cise as soon as new movement is achieved.
Types of Incontinence
There are a number of different types, the
most common being stress incontinence,
urge incontinence and mixed incontinence.
Stress Incontinence
This is associated with the leakage of small
amounts of urine during sneezing, coughing
and other activities which increase the pres-
sure in the abdomen. It is more common in
females and occurs when the bladder neck
and other control mechanisms are not working correctly.
Urge Incontinence
An overactive bladder cause leakage of large amounts of urine at
unexpected times, including sleep. Sufferers experience a sudden
strong urge to go to the toilet and are often unable to retain the
urine. The frequency of urination also increases causing problems
for everyday life.
Mixed Incontinence
It is a combination of the above two types.
Electrical Stimulation
Brief courses of electrical stimulation can strengthen muscles in the
lower pelvis in a similar way to exercising the muscles. Electrodes
are temporarily placed in the vagina or rectum to stimulate nearby
muscles. This helps to stabilise overactive muscles and stimulate
contraction of urethral muscles. Electrical stimulation can be used to
reduce both stress and urge incontinence.
The Stress Incontinence programme is based on strengthening the
muscles of the pelvic oor. Once strength has been improved, the
muscles are better able to resist urinary leakage caused by external
pressures applied to the bladder.
Low frequency currents used in this programme increase the blood
ow to the muscles increasing their resistance to fatigue and reduc-
ing the involuntary contractions of the bladder.
98
Following Nerve or Muscle Grafting
The use of stimulation will improve circulation and help with the pro-
duction of spontaneous movement patterns.
Treat for 1 hour per day with specic focus on reinnervating areas.
NB. Following surgical damage to the nerve e.g acoustic neuroma
or parotid tumou r re m oval the natural reco very process of
axonotnemesis will take longer. Maximum recovery potential may
take between 2 -3 years in the former case.
Chapter 3 : CAUTIONS
Read the operation manual before using the device.
Federal law (USA) restricts this device to sale by or on
the order of a physician/practitioner.
Indications
The device is a TENS, EMS, Interferential, Pelvic and Facial
stimulator used for symptomatic relief, management of chronic
intractable pain, muscle training, incontinence treatment and facial
nerve stimulation. It is intended for use on the order of a physician
only.
TENS,IF
1. Federal law (USA) restricts this device to sale by or on the order
of a physician.
2. Do not use this device for undiagnosed pain syndromes until
consulting a physician.
3. Patients with an implanted electronic device, such as a cardiac
pacemaker, implanted debrillator, or any other metallic or
electronic device should not undergo the treatment without rst
consulting a doctor.
4. Patients with heart disease, epilepsy, cancer or any other health
condition should not undergo the treatment without rst
consulting a physician.
5. Stimulation delivered by this device may be sufcient to cause
electrocution. Electrical current of this magnitude must not ow
through the thorax or across the chest because it may cause a
cardiac arrhythmia.
6. 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 difcult, and may have adverse effects on the heart
rhythm or blood pressure.
7. Do not place electrodes on your head or at any sites that may
cause the electrical current to ow transcerebrally (through the
head).
8. 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.
9. Turn the device off before applying or removing electrodes.
10. Isolated cases of skin irritation may occur at the site of electrode
placement following long term application. If this occurs, discontinue
use and consult your physician.
11. If the electrical therapy becomes ineffective or unpleasant,
stimulation should be discontinued until its use is re-evaluated by
a physician
12. Keep this device out of the reach of children.
13. The device has no AP/APG protection.
Do not use it in the presence of explosive atmosphere and
ammable mixture.
EMS, Pelvic and Facial stimulation
1. Federal law (USA) restricts this device to sale by or on the order
of a physician
2. Safety of powered muscle stimulators for use during pregnancy
has not been established.
3. Caution should be used for patients with suspected or diagnosed
heart problems.
4. Caution should be used for patients with suspected or diagnosed
epilepsy.
5. 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
1110
may disrupt the healing process;
c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation.
6 Some patients may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive medium.
The irritation can usually be reduced by using an alternate
conductive medium, or alternate electrode placement.
7. Electrode placement and stimulation settings should be based
on the guidance of the prescribing practitioner.
8. Powered muscle stimulators should be kept out of the reach of
children.
9. Powered muscle stimulators should be used only with the leads
and electrodes recommended for use by the manufacturer.
10.Portable powered muscle stimulators should not be used while
driving, operating machinery, or during any activity in which
involuntary muscle contractions may put the user at undue risk
of injury.
Chapter 4 : WARNINGS
1. The long-term effects of chronic electrical stimulation are unknown.
2. The devices should be used only under the continued supervision
of a physician.
3. This device is a symptomatic treatment and as such suppresses
the sensation of pain, which would otherwise serve as a protective
mechanism.
4. The device has no curative value.
5. This device is not effective for pain of central origin. (This may
include headache.)
6. Electronic monitoring equipment (such as ECG monitors and
ECG alarms) may not operate properly when stimulation is in use.
7. Caution should be used in applying the device to patients sus-
pected of having heart disease. Further clinical data is needed
8. Electrodes should not be placed over the eyes, in the mouth, or
internally.
9. Do not use while sleeping
10. The interferential stimulator is for external use only.
11. Do not place the electrodes over the carotid nerve, particularly in
patients with a known sensitivity to the carotid sinus reex.
12. Electrical stimulation safety has not been established during
pregnancy. Do not use the device during pregnancy.
13. Stimulation should not be applied over swollen, infected, or
inamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,
varicose veins, etc.
14.Stimulation should not be applied over, or in proximity to,
cancerous lesions.
15.Do not immerse the stimulator into water or other liquids.
Chapter 5: CONTRAINDICATION
TENS/EMS/IF/Facial
1. Do not use the device over the carotid sinus (neck) region.
2. The devices can affect the operation of demand type cardiac
pacemakers.
3. Do not use the device if you have heart disease without consulting
your physician.
4. Do not stimulate on the site that may cause current to ow
transcerebrally – (through the head).
5. Do not apply the device for undiagnosed pain syndromes until
aetiology is established.
Pelvic Stimulation
1. Do not use incontinence stimulator if suffering from a muscle dis-
order.
2. Do not use incontinence stimulator if a bladder or vaginal
infection is present.
3. Do not use the incontinence stimulator if you have been
diagnosed or treated for cervical cancer.
4. Do not use incontinence stimulator if you have, or have had, epilepsy.
1312
Chapter 6: PRECAUTIONS/ADVERSE REACTIONS
1. Isolated cases of skin irritation may occur at the site of electrode
placement during long-term application.
2. Effectiveness is dependent upon patient selection by a person
qualied in the management of pain patients.
3. On rare occasions skin irritation and electrode burns are
potential adverse reactions. If irritation occurs, discontinue use
and consult your physician.
Chapter 7 : CONSTRUCTION
FRONT
(1) LEAD CONNECTOR
(2) ON/OFF/PAUSE CONTROL
(3) LIQUID CRYSTAL DISPLAY
(4) MODE CONTROL(FORWARD)
(5) MODE CONTROL(BACKWARD)
(6) SET CONTROL
(7) SETTING INCREMENT CONTROL(PROGRAM SELECTOR)
(8) SETTING DECREMENT CONTROL(PROGRAM SELECTOR)
(9) INTENSITY INCREMENT/DECREMENT CONTROL
(10) AC POWER CONNECTOR
(11) LED
TOP
Front
Bottom
1514
Liquid Crystal Display
1. Intensity Level
2. Modality
3. Mode
4. Setting
5. Lock
6. Low Battery Indicator
7. Waveform
BACK
(12) BELT CLIP
(13) BATTERY CASE
Chapter 8 : TECHNICAL SPECIFICATIONS
The technical specification details of ULTRA 9000 Digital MULTI-
FUNCTION COMBO STIMULATOR are as follows:
MECHANISM TECHNICAL DESCRIPTION
01. Channel Dual, isolated between channels
02. Pulse Amplitude TENS , EMS: 0-100mA (500 ohm), each
channel can be adjusted separately in 99
steps of intensity control.
IF, Pelvic,Facial: 0-60mA (500 ohm), both
channel can be adjusted simultaneously in
60 steps of intensity control.
03. Wave Form TENS, EMS, Pelvic & Facial: Asymmetrical
Bi-Phasic Square Pulse
IF: Symmetrical Balanced Sine Wave
04. Voltage TENS, EMS : 0 to 50V (Load: 500 ohm)
IF,Pelvic,Facial: 0-30V(Load: 500ohm)
05. Power source
TENS, EMS, Pelvic, & Facial :One 9 Volt Battery
or AC power source IF: AC power source only
06. Size 135mm(L) x 69mm (W) x 32mm(H)
07. Weight 215 grams with battery.
08 Modality Five modalities, TENS, EMS, IF, Pelvic and
Facial selectable by press buttons.
09 Timer TENS, EMS: Adjustable, from 1 to 60
minutes and continuous(C), 1 minute each
step from 1 to 15 minutes, 5 minutes each
step from 15 to 60 minutes.
IF: Adjustable, from 1 to 30 minutes and
continuous(C), 1 minute each step from 1
to 15 minutes, 5 minutes each step from 15
to 30 minutes.
The timer of preset programs for the units
is not adjustable.
10 Low Battery A low battery indicator will show up on the
Indicator LCD when the battery is low.
11 Patient
The individual treatment time can be recorded.
SIDE
(15) LOCK FACILITY
(16) SIDE STRIP
1716
Compliance Meter
Sixty sets of treatment records can be
stored. Total recorded time is 999 hours.
12 Operating Temperature:0°~40°C
Condition Relative Humidity: 30%~75%
Atmosphere Pressure : 700Hpa~1060Hpa
13 Lock The intensity level and settings can be
locked by press button. Prevents the patient
from accidentally changing any of the set
parameters .
14.
Audio Adjustment
The beep sound of the device can be adjusted
or turned off by press buttons.
15. Remark There may be up to a +/-10% tolerance of
all parameters and +/-20% tolerance of
amplitude & voltage.
TENS/EMS
1. Pulse Rate Adjustable, from 2 to 150 Hz, 1 Hz/step
2. Pulse Width Adjustable, from 50 to 400 microseconds,
10 μs/step
3. On Time Adjustable, 2~90 seconds , 1 Sec./ step
4. Off Time Adjustable, 0~90 seconds , 1 Sec./ step
5. Ramp Time Adjustable, 1~8 seconds, 1 Sec./ step, The
“On” time will increase and decrease in the
setting value.
6. Mode Six TENS Modes: B(Burst), N(Normal),
M(Modulation Rate & Width),
S1( Modulation Width), S2(Modulation
Width), P(P1-12)
Four EMS Modes:C(Constant),
S(Synchronous), A(Alternate), P(P1-12)
Six Pelvic Floor Stimulation Programs:
P(P1-P6)
Six Facial Nerve Paralysis Treatment
Programs : P(P1-P6)
7. Burst Mode Burst rate: Adjustable, 0.5 – 5Hz
Pulse width adjustable, 50~400μs
Frequency xed = 100 Hz
8. Normal Mode
The pulse rate and pulse width are adjustable.
It generates continuous stimulation based
on the setting value.
9.
Modulation Mode
Modulation mode is a combination of pulse
rate and pulse width modulation. The pulse
rate and width are automatically varied in a
cyclic pattern. The pulse width is decreased
by 50% from its original setting in 0.5 second,
then the pulse rate is decreased by 50%
from its original setting in 0.5 second. Total
cycle time is 1 second. In this mode, pulse
rate(2-150Hz) and pulse width(50-300µs)
are fully adjustable.
10. S1 Mode Pulse width is automatically varied in a
cyclic pattern over a nominal 10 second
period. Pulse width decreases over a period
of 4 seconds from the initial setting to a
value 40% less. The narrower pulse width
continues for 1 second. It then increases
over a period of 4 seconds to its initial setting.
The cycle is then repeated. Pulse rate and
pulse width are fully adjustable.
11. S2 Mode Pulse width is automatically varied in a
cyclic pattern over a nominal 10 second
period. Pulse width decreases over a period
of 4 seconds from the initial setting to a
value 70% less. The narrower pulse width
continues for 1 second. It then increases
over a period of 4 seconds to its initial setting.
The cycle is then repeated. Pulse rate and
pulse width are fully adjustable.
12.
Constant Mode(C)
T
he pulse rate and pulse width are adjustable.
Continuous stimulation is delivered
13. Synchronous
Output from both channels occurs synchronously.
Mode(S) The “ON” time includes “Ramp Up” and
“Ramp Down” time. Therefore, the setting
1918
of ON Time should be no less than two
times of the “Ramp” time in this mode.
14. Alternate The stimulation of the CH2 will occur after
Mode(A) the 1st contraction of CH1 is completed. In
this mode, the setting of ON Time should
be no less than two times of the “Ramp”
time. The OFF Time should be equal to or
greater than the ON Time.
OFF TIME ≥ON TIME
15. P Mode(P) Preset programs with xed settings and
timer, selected by press buttons.
Only intensity level is adjustable.
16. Preset Programs Twelve preset programs selectable by
of TENS(P Mode)
press buttons from P1 to P12.
Mode Rate Width Timer
(Hz) (μs) (Min)
P1 Constant 80 180 Continue
P2 Burst 100 180 Continue
(Burst Rate: 2Hz)
P3 Modulation 80 70-180 Continue
P4 Mixed Frequency 15-2 180 Continue
P5 Mixed Frequency 80-2 180 Continue
P6 Constant 80 60 Continue
P7 Modulation 80 60 Continue
P8 Constant 10 200 Continue
P9 Burst 50 250 Continue
P10 Modulation 5-125 120 Continue
P11 Modulation 2-100 260-150 Continue
P12 Modulation 7-80 260 Continue
17. Preset Programs Twelve preset programs selectable by
of EMS(P Mode) press buttons from P1 to P12.
SYN/ALT Rate Width Ramp On Time Off Time Timer
(Hz) (μs) (Sec) (Sec) (Sec) (Min)
P1 Synchronous 35 300 3 8 24 20
P2 Synchronous 80 300 3 10 5 20
P3 Synchronous 80 250 2 8 4 20
P4 Synchronous 25 200 2 6 30 15
P5 Synchronous 35 300 2 5 15 30
P6 Synchronous 50 300 5 15 50 15
P7 Synchronous 25 260 1 5 2 30
P8 Synchronous 25 280 2 10 3 30
P9 Synchronous 35 400 2 6 10 30
P10 Synchronous 8 400 2 6 10 30
P11 Alternate 50 350 2 10 10 20
P12 Alternate 50 350 2 14 4 20
Interferential Stimulation
1.
Carrier Frequency
4000Hz xed (CH1)
2. Modulating 4004-4160Hz, Adjustable (CH2)
Frequency
3. IF Frequency 10 Modes Selectable by press buttons.
Mode Constant Mode(C): Constant stimulation,
4-160bps, Adjustable
Frequency Shift: Five modes, 1/1 abrupt
shift, 6/6 abrupt shift, 6/6 ramped, 10/10
abrupt shift, 10/10 ramped, bps can be
adjusted.
Auto Sweep: Three modes, 4-45
bps(SW1), 80-145 bps(SW2) & 4-SET
bps(R)
Sweep Time: 15 seconds
Frequency Shift Percent: Frequency shifts
from 30% below the set frequency to 60%
above and then return to 30% below the set
frequency.
Preset programs: P(P1-P6)
4.
Programs Details
There are six preset IF programs selected
by the increment and decrement buttons on
the P mode.
Mode Frequency Sweep or Timer(Min)
Dwell Time
P1 Abrupt 1-10 Hz 2 Sec 30
P2 Abrupt 1-20 Hz 6 Sec 30
P3 Abrupt 1-30 Hz 9 Sec 30
2120
P4 Sweep 1-30 Hz 8 Sec 30
P5 Sweep 80-150 Hz 15 Sec 30
P6 Sweep 1-150 Hz 8 Sec 30
5. Output Quad polar (4 electrodes)
Conguration
6.
Interference Pulse
4-160 bps, Adjustable, 4 bps/step
Freq
7. Pulse Duration 125μs maximum
8. Output There are nine modes: On constant mode,
Parameters ve modes with frequency shift and three
modes with Auto sweep. The mode name
on the liquid crystal display will be ashing
when selected.
9.
Constant Mode(C)
This mode gives constant stimulation at set
pulse frequency. The interference pulse
frequency(bps) is adjustable at 4-160 bps
10 Frequency Shift There are ve modes of Frequency Shift.
The interference pulse frequency (bps)is
adjustable.
1. 1/1 abrupt shift: The pulse frequency varies from –30% to
+60% of the set pulse frequency. One second at the lower
frequency and one second at the higher frequency.
The transition from one frequency to the other is abrupt
(square wave).
2. 6/6 abrupt shift: The pulse frequency varies from –30% to
+60% of the set pulse frequency. Six seconds at the lower
frequency and six seconds at the higher frequency.
The transition from one frequency to the other is abrupt
(square wave).
3. 6/6 ramped shift: The pulse frequency sweeps from –30% to
+60% of the set pulse frequency. Over a period of 6 seconds
the frequency changes from low to high and then changes
from high to low over another period of 6 seconds. The
transition is ramped (triangular wave).
4. 10/10 abrupt shift: The pulse frequency varies from –30% to
+60% of the set pulse frequency. Ten seconds at the lower
frequency, and ten seconds at the higher frequency.
The transition from one frequency to the other is abrupt
(square wave).
5. 10/10 ramped shift: The pulse frequency sweeps from –30%
to +60% of the pulse frequency. Over a period of 10 seconds
the frequency changes from low to high and then changes
from high to low over another period of 10 seconds. The
transition is ramped (triangular wave).
: Abrupt Shift
: Ramped Shift
11. Auto Sweep (R ) The frequency is modulated through the
selected range. There are three ranges
available:
1. 4-45 bps.( Not adjustable)
2. 80-145 bps.(Not adjustable)
3. 4-SET : Modulated between 4 bps and
User Dened bps.
The sweep time is 15 seconds.
Pelvic Stimulation
1. Programmes Six preset programmes selected by press
buttons from P1 to P6
2. Programmes The programme details are as follows.
Details Parameters are preset at xed values. The
(P1,2,3,5) 2 seconds ramp time includes 1 second
ramp up, and 1 second ramp down. Each
programme is repeated in a constant cyclic
pattern.
Rate Width Contract Relax Ramp Cycle Timer
(Hz) (µs) (Sec.) (Sec.) (Sec.) (Sec.) (Min.)
1 35 250 4 8 2 14 30
2 40 200 6 15 2 23 30
3 10 250 5 3 2 10 30
5 20 250 5 5 2 12 30
3. Programme Programme 4 is composed of 12 sections
Details(P 4) with varied pulse rates. Each section
contains 30 contractions. The 2 seconds
ramp time includes 1 second ramp up, and
2322
1 second ramp down. It is repeated in a
constant cyclic pattern. The details of the
programme are given below.
Section Rate Width Contract Relax Ramp Cycle
(Hz) (µs) (Sec.) (Sec.) (Sec.) (Sec.)
1 7 150 4 4 2 10
2 8 150 4 4 2 10
3 9 150 4 4 2 10
4 10 150 4 4 2 10
5 11 150 4 4 2 10
6 12 150 4 4 2 10
7 13 150 4 4 2 10
8 14 150 4 4 2 10
9 15 150 4 4 2 10
10 16 150 4 4 2 10
11 12 150 4 4 2 10
12 7 150 4 4 2 10
Timer: 60 min.
4. Programme 6 For overall Pelvic Floor exercise
Section Time Pulse Rate Pulse Width Ramp On Tim Off Time
(Min) (Hz) (μs) (Sec) (Sec) (Sec)
1 5 10 220 0.8 6 8
2 10 20 275 0.8 6 8
3 10 35 220 0.8 5 10
4 10 10 250 0.8 6 10
Timer: 35 min.
Facial Stimulation
1. Programmes Six preset programmes selected by press
buttons from P1-P6
2. Palsy Programme 1
Output: Synchronous
Pulse Width: Fixed
Pulse Rate: Modulated from 5 to 10Hz
Contraction/Relaxation Time: Fixed
Treatment Time: Fixed at 60 min.
3. Palsy Programme 2
Output: Synchronous
Pulse Width: Fixed
Pulse Rate: Fixed at 10Hz
Contraction /Relaxation Time: Fixed
Treatment Time: Fixed at 180 min.
4. Muscle Programme 3
Strengthing Output: Synchronous
Pulse Width: Fixed
Pulse Rate: Fixed at 20Hz
Contraction /Relaxation time: Fixed
Treatment Time: Fixed at 180 min.
5. Facial Programme 4
Synkinesis Output: Alternate
Pulse Width: Fixed
Pulse Rate: Fixed at 5 Hz
Contraction /Relaxation Time: Fixed
Treatment Time: Fixed at 30 min.
6. Facial Programme 5
Synkinesis Output: Synchronous
Pulse Width: Fixed
Contraction /Relaxation Time: Fixed
Pulse Rate: Modulated from 14 to 5 Hz
Treatment Time: Fixed at 30 min.
7. Facial Programme 6
Skynkinesis Output: Synchronous
Pulse Width: Fixed
Pulse Rate: Modulated from 5 to 14 Hz
Contraction/Relaxation Time: Fixed
Treatment Time: Fixed at 30 min.
2524
Chapter 9 : REPLACEABLE PARTS
The replaceable parts and accessories of ULTRA 9000 DIGITAL
MULTI-FUNCTION COMBO STIMULATOR devices are as given
below –Except leads, electrodes, battery and battery case cover,
please do not try to replace the other parts of a device.
PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9V BATTERY ,TYPE 6F22
04 BELT CLIP
05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAIN PCB
08 PRESS BUTTONS
09 LCD
10 PANEL COVER
12 LOCK BUTTON
13 SIDE STRIP
14 LED LAMP
15 AC POWER CORD
Chapter 10 : ACCESSORIES
Each ULTRA 9000 Digital MULTI-FUNCTION COMBO STIMULATOR
comes complete with standard accessories and the standard labels
as given below:
I. Accessories
REF. NO. DESCRIPTION QTY
1. KF5050 50 X 50 mm Self Adhesive Electrodes 4 pieces
2. KB-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
6. AC Power Adapter 1 piece
The optional accessories for the device are available by order.
Please contact your distributor for buying the products if needed.
Please use only legally approved accessories for your device.
Optional Electrodes for Pelvic Stimulation
A. Vaginal and Rectal Probes for Pelvic Floor Stimulation
Model # Type Diameter Model # Type Diameter
PR-02A Vaginal 28mm PR-06A Rectal 14mm
PR-03A Vaginal 25mm PR-09A Rectal 24mm
PR-04A Vaginal 20mm PR-13A Rectal 19.6mm
PR-08A Vaginal 34mm PR-17A Rectal 18mm
PR-16A Vaginal 33mm PR-19A Rectal 18mm
PR-20A Rectal 15.8mm
B. Adhesive Electrodes for Pelvic Floor Stimulation
Model # Size
KF100 40x53mm
KF200 65x70mm
Optional Electrodes for Facial Nerve Stimulation
A. Adhesive Electrodes
Model # Shape Size
KF25D Round 2.5cm Diameter
B. Metal Electrodes
Model # Description
D20 Facial electrodes w/2mm red pigtail connection
D21 Facial Electrodes w/2mm black pigtail connection
II. LABEL
The label attached to the back of the device contains important in-
formation about this device- model, supply voltage, CE number and
caution. Please do not remove.
2726
Chapter 11 : GRAPHIC SYMBOLS
1. Degree of Electrical Protection BF
2. Do not insert the plug into AC power supply socket
3. Timer
4. Consult Operation Instructions
5. Manufacturer
6. Serial Number
7. Lock
8. Low Battery
9. DC Current(DC Power source)
10. Comply with MDD 93/42/EEC requirements as
amended by 2007/47/EC.
Notify body Det Norske Veritas(DNV).
Chapter 12: OPERATING INSTRUCTIONS
General Instructions for TENS, EMS AND IF
1) Clean the skin.
2) Insert the 9V battery into the device’s battery compartment. Make
sure that the plastic seal on the 9V battery is removed. Line up
the
positive and negative terminals on the battery with their
corresponding
terminals in the device. Make sure that the unit is
turned off.
Remark: The IF can only be used when the AC power adapter is
connected because of large consumption of power.
Please remove the 9V battery when the AC power adapter
is connected. We suggest to use the IF device 15
minutes each session to avoid over-heating. Unplug the
power cord and stop using the unit for 15 minutes after
each session is completed.
3) Insert the lead wires into the lead wire sockets on top of the
device. Both wires must be connected when IF is used.
4) Open the electrode package. Then insert each lead wire pin
into the pig tail of the electrodes
5) Place the electrode on your body as directed by your physician.
6) Turn on the power by pressing the power On/Off/Pause button.
7) Select the mode and settings as directed by your physician.
8) Slowly increase or decrease the intensity by pressing the
intensity control buttons.
(The intensity level of IF of both channels can be adjusted
simultaneously when one of the channels is adjusted. Individual
adjustment for intensity of IF is not possible.)
9) You may press the On/Off/Pause button if you want to stop
treatment for a while.
10) Press “lock” button to lock the settings.
11) After treatment, turn the device off by pressing the On/Off/
Pause button.
12) Remove the electrodes and put them back into the sealed bag.
13) Remove the lead wires connecting the device.
14) Remove the AC power cord. Put the device and accessories
back in the carrying case
Pelvic Floor Stimulation
1. Use the toilet before beginning the treatment if necessary
2. Clean the probe as per the instructions.
3. Make sure the stimulator is turned off before use.
2928
4. Connect the cable of probe to the device as per the instructions.
5. Apply a thin coating of lubricating gel on the vagina opening or
apply a small amount of gel on the tip of the probe.
6. Insert the probe into the vagina, (make sure the metal contacts
are facing sideways) until the ange at the base of the probe is
just on the outside and is vertical.
7. Lay down or sit in a comfortable position with
your knees up and your back supported by a
cushion or pillow.
8. Press the “On/Off” button for 2 seconds to
switch the unit on
9. Press the “On/Off” button to select a programme.
There are 5 programmes available. The details of each
p r o g r a m m e a r e d e s c r i b e d i n t h e s p e c i c a t i o n s .
10. Press the “Intensity Increase” button to increase the amplitude
11. Press the “Intensity Decrease” button to decrease the amplitude.
12. After use, press the “On/Off” button to switch off the unit.
13. Disconnect the lead from the control unit.
14. Remove the probe from the vagina by holding the ange.
15. Clean the probe as per the instructions.
Optional Anal Probe
The stimulator can also be used with an anal probe.
Place probe as shown below and proceed as for
continence stimulation
Optional Surface Electrodes
The stimulator can also be used with surface electrodes. Place the
electrodes as shown below and proceed as for continence stimula-
tion.
Treatments of the Pelvic Programs
P1: Stress Incontinence
P2: Stress Incontinence
P3: Urge Incontinence
P4: Enduring Building
P5: Maintenance of Pelvic Floor
P6: Overall Pelvic Floor exercise
Palsy Treatment
1. Clean the skin.
2. Insert the 9V battery into the device’s battery compartment.
Make sure that the plastic seal on the 9V battery is removed.
Line up the positive and negative terminals on the battery with
their corresponding terminals in the device. Make sure that the
unit is turned off.
3. Insert the lead wires into the lead wire sockets on top of the
device.
4. Open the electrode package. Then insert each lead wire pin
into the pig tail of the electrodes
5. Place the electrode on your face as directed by your physician.
6. Turn on the power by pressing the power On/Off/Pause button.
7. Select the program by pressing the “Increment” or “Decrement”
buttons as directed by your physician.
8. Slowly increase or decrease the intensity by pressing the
intensity control buttons.
9. You may press the On/Off/Pause button if you want to stop
treatment for a while.
10. Press “lock” button to lock the settings.
11. After treatment, turn the device off by pressing the On/Off/Pause
button.
12. Make sure the power is off before removing electrodes.
13. Remove the electrodes and put them back in the sealed bag.
14. Remove the lead wires connecting the device.
3130
Facial Treatment Guidelines
Facial Muscles
Facial Electrical Stimulations
Electrical stimulation is sometimes given to patients with facial
palsy.
The facial nerve normally emits electrical impulses to give muscles
their tone and shape. When the facial nerve is damaged the muscle
no longer receives these messages and as a result the muscles
become weak and oppy. External electrical stimulation can try and
mimic these electrical impulses and help restore muscle tone.
It should only be used under the guidance of a therapist with spe-
cialist training in the management of facial palsy. Use of electrical
stimulation should be closely monitored by the therapist. Patients
should not try this treatment without supervision as there are some
indications that it may cause harm when used incorrectly.
If there is every possibility that the nerve will recover spontane-
ously, albeit incompletely, then it may be better to let nature take
its course. The person should massage their face twice daily which
helps to maintain circulation and mobility of the facial muscles and
also maintains the feeling of movement (which cannot be gained via
electrical stimulation). The main focus in the early weeks of recov-
ery is protecting the eye and facial massage.
As the facial nerve recovers it will start to re electrical impulses
back into the facial muscles and you will see the muscle tone return.
If you continue to use external electrical stimulation at this point
the muscles will become over stimulated. The result is short, tight,
stiff muscles that cannot move. Tight muscles become painful and
may spasm or twitch. It may also cause unwanted movement in the
muscles on the affected side of your face, (synkinesis).
The image at left illustrates
the parotid gland area, where
the facial nerve divides into its
major branches after exiting
the skull at the stylomastoid
foramen. The major branches
then continue to divide into
thousands of microscopic
nerve bers.
3332
There are many physical symptoms associated with facial paralysis,
but the effects will differ between individuals. They can vary in
accordance with the degree of nerve damage, and the location of
the damage.
GENERAL
EYE RELATED
Muscle weakness or paralysis
Forehead wrinkles disappear
Overall droopy appearance
Impossible or difcult to blink
Nose runs
Nose is constantly stuffed
Difculty speaking
Difculty eating and drinking
Sensitivity to sound (hyperacusis)
Excess or reduced salivation
Facial swelling
Diminished or distorted taste
Pain in or near the ear
Drooling
Eye closure difcult or impossible
Lack of tears
Excessive tearing
Brow droop
Tears fail to coat cornea
Lower eyelid droop
Sensitivity to light
ADDITIONAL SYMPTOMS WITH
RAMSEY HUNT SYNDROME
Hearing decit
Severe pain
Long lasting pain
Vertigo
Blisters in ear or other areas
Nausea
Facial Programmes
There are six Facial programmes
P1 Facial Palsy
P2 Facial Palsy
P3 Muscle Strengthening
P4 Facial Synkinesis
P5 Facial Synkinesis
P6 Facial Synkinesis
Adjust the output until you can feel the facial muscle just moving.
Do not overstimulate as this will cause muscle fatigue and
discomfort. It may also reduce the benets of stimulation. During
treatment the chosen programme may fell more or less intense,
this is quite normal and no adjustment should be made unless it is
uncomfortable.
Programmes P1-P4 are used for the treatment of facial palsy.
Programmes P5-P6 are used for the treatment of synkinesis.
Please speak to your health care professional in relation to the
correct choice of programme.
3534
Electrode Placement
Electrode placement is crucial when treating facial palsy with
stimulation. As most facial muscles are small it is important to treat
individual muscles, and use only the electrodes provided. Treatment
of a group of muscles with larger electrodes may well have the
opposite effect. Please speak to a health care professional for
further advice on the correct electrodes placement.
Chapter 13 : PARAMETER CONTROLS
PULSE DURATION
Wider pulse duration settings will deliver stronger stimulation for any
given intensity setting. As mentioned in the Controls section, by
using a combination of intensity and pulse duration different nerve
bres are stimulated.
The wider pulse duration is needed to recruit motor bres, whereas
the narrow pulse duration is used on the sensory bres. The choice
of which pulse duration to use is partially dependent upon the Treat-
ment Mode and Protocol selected.
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends upon
the type of electrode placement given to the patient.
When using contiguous and dermatome electrode placements (i.e.
stimulating directly through the area of pain or localized innnerva-
tion), a higher pulse rate (setting greater than 80Hz on the Pulse
Rate Control) is required. The patient should not perceive individual
pulses but rather have the sensation of steady continuous stimula-
tion.
When using point treatments, it has been suggested that lower
pulse rates be utilized (less than 10Hz). With this setting the patient
should be able to perceive individual pulses.
When using multiple electrode placement strategies, such as com-
binations of point and contiguous electrode placements, the higher
pulse rates are suggested.
Despite the above recommendations, individual patients may re-
quire slight variations of the above settings, according to the nature
of their condition.
3736
TREATMENT MODE
Normal or Conventional TENS offers the practitioners complete con-
trol over all the various treatment parameters of the instrument.
Burst Mode is analogous to the Low Rate TENS technique except
the low frequency individual pulses are replaced by individual “bursts”
of 7-10 individual pulses. It is thus a combination of Conventional
TENS and Low Rate TENS. In Burst Mode, the treatment frequency
is adjustable in the range between 0.5Hz – 5Hz.
Modulated Mode attempts to minimise nerve accommodation by
continuously cycling the treatment intensity. Advise the patient to
increase the intensity very slowly when using modulation mode.
INTENSITY
Each patient responds differently to different levels of intensity, due
to varying degrees of tissue resistance, innervation, skin thickness,
etc. Intensity instructions are therefore limited to the following set-
tings:
Perception – The intensity is increased so that the patient can feel
the stimulation, but there is no muscular contraction.
Slight Contraction – Intensity is increased to a barely visible muscu-
lar contraction that is not strong enough to move a joint. When us-
ing low pulse rate settings, this will show as individual twitches. At
higher pulse rates there will simply be increased muscle tension.
Strong muscular contraction is typically not used in TENS therapy.
However, muscular contraction may be useful if the pain involves a
cramped or spastic muscle. The TENS can be used as a traditional
muscle stimulator in the circumstances to quickly break the spasm.
Use a higher pulse rate, wide pulse duration and set the intensity
to visible contraction (still within patient tolerance). Twenty or thirty
minutes of such a tetanized muscular contraction will generally
break the spasm. In all cases, if the patient complains that the stim-
ulation is uncomfortable, reduce intensity and/or cease stimulation.
TIME DURATION
The onset of pain relief should occur shortly after the intensity set-
ting has been determined. However, in some cases, pain relief may
take as long as 30 minutes to achieve, especially when using point
electrode placements and slow pulse rates.
TENS units are typically operated for long periods of time, with a
minimum of 20 – 30 minutes and in some post-operation protocols,
as long as 36 hours.
In general, pain relief will diminish within 30 minutes of the ces-
sation of stimulation. Pain relief obtained through point electrode
placements may last longer (perhaps because of the presence of
endorphins).
CONTRACTION / RELAXATION
The contraction time and relaxation time of EMS is adjustable.
Stimulation will commence at the contraction setting time and cease
at the relaxation setting time. Then the cycle starts over again –
Stimulation, Contraction and Relaxation.
RAMP
In order to achieve a comfortable exercise and avoid discomfort be-
cause of immediate current onset, each contraction may be ramped
so that the signal comes on gradually and smoothly. The intensity of
electrical current will reach the set level within the Ramp time. It will
NOT reach the desired level if the ramp time is greater than the total
contraction time.
OUTPUT MODE
The output of both channels are adjustable. Stimulation can be
synchronous or alternate. Stimulation of both channels will occur at
the same time when synchronus pattern is selected. In alternating
mode, the stimulation from CH2 will occur after contraction of CH1
is nished.
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