Sonopuls 692 6-Series User Manual
Sonopuls 692 6-Series User Manual
Sonopuls 692 6-Series User Manual
User Manual
Copyright:
Enraf-Nonius B.V.
P.O. Box 12080
Vareseweg 127
3004 GB Rotterdam
The Netherlands
Tel: +31 (0)10 – 20 30 600
Fax: +31 (0)10 – 20 30 699
[email protected]
www.enraf-nonius.com
2 FOREWORD........................................................................................................................ 12
3 PRECAUTIONARY INSTRUCTIONS.................................................................................. 13
5.1
5.1.1
Ultrasound....................................................................................................................... 26
Indications/Contraindications and Adverse Effects for Ultrasound...........................................................26
5
5.1.2 Parameters ..............................................................................................................................................27
9 INSTALLATION................................................................................................................... 33
10.1 Electrotherapy................................................................................................................. 34
10.1.1 Before treatment ......................................................................................................................................34
10.1.2 Flexible rubber electrodes........................................................................................................................34
10.1.3 Vacuum electrodes ..................................................................................................................................36
10.1.4 Self-adhesive electrodes..........................................................................................................................36
10.1.5 Electrolytic effects ....................................................................................................................................36
10.1.6 Current density.........................................................................................................................................36
10.1.7 Connection and disconnection reactions..................................................................................................37
13 ILLUSTRATIONS ............................................................................................................. 87
14 SPECIFICATIONS............................................................................................................ 96
9
1 Product Description
The 6-series is based on a modular system. This means that a number of modules are
integrated within a single structure.
The base module consists of a user interface and an Endomed electro therapy module, which
has two independent current channels.
The 6-series offers protocol driven operation, providing either factory or user defined sequences
of treatment steps. Protocols can run on linked or independent channels.
With independent channels, two different protocols can be run simultaneously. All settings can
easily be adjusted via the user interface, which is shown on the graphical colour display.
The therapy modules, - Endomed electro therapy, Sonopuls ultrasound and Vacotron vacuum -
are described below.
WARNING (USA only): The 600-series is a prescription device that should only be used under
the supervision or by the order of a physician or other licensed healthcare provider.
The continuous and pulsed vacuum module allows vacuum electrodes to be positioned quickly
and easily. Furthermore, it is extremely simple to switch between the treatment with vacuum
electrodes and treatment with flexible rubber electrodes. This makes the vacuum module an
ideal aid for electrode placement.
10
Vacuum electrodes make good contact with the skin which means that effective use is made of
the whole electrodes area. The massage effect resulting from the pulsed vacuum ensures a
good flow of blood through the skin under the electrodes. This reduces the resistance of the skin
and increases the effectiveness of the stimulating current.
The EMG module is equipped with 2 EMG channels for surface electrodes, vaginal and anal
electrodes. The pressure sensor can be used in combination with vaginal and anal pressure
probes.
Several measure methods are applicable via de EMG channels and these channels can be
used in combination with the stimulation current wave forms from the electrotherapy module.
11
2 Foreword
This manual has been written for the owners and operators of the 600-series. It contains
general instructions on operation, precautionary practices, maintenance and parts information.
In order to maximize the use, efficiency and lifespan of your unit, please read this manual
thoroughly and become familiar with the controls as well as the accessories before operating
the unit.
Specifications put forth in this manual were in effect at the time of publication. However, owing
to Enraf-Nonius BV’s policy of continual improvement, changes to these specifications may be
made at any time without obligation on the part of Enraf-Nonius BV.
A law on Product Liability has become effective in many countries. This Product Liability law
implies, amongst other things, that once a period of 10 years has elapsed after a product has
been brought into circulation, the manufacturer can no longer be held responsible for possible
shortcomings of the product.
To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its
suppliers or resellers be liable for any indirect, special, incidental or consequential damages
arising from the use of or inability to use the product, including, without limitation, damages for
loss of goodwill, work and productivity, computer failure or malfunction, or any and all other
commercial damages or losses, even if advised of the possibility thereof, and regardless of the
legal or equitable theory (contract, tort or otherwise) upon which the claim is based. In any case,
Enraf-Nonius’s entire liability under any provision of this agreement shall not exceed in the
aggregate the sum of the fees paid for this product and fees for support of the product received
by Enraf-Nonius under a separate support agreement (if any), with the exception of death or
personal injury caused by the negligence of Enraf-Nonius to the extent applicable law prohibits
the limitation of damages in such cases.
The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all
claims arising from third parties, whatever nature or whatever relationship to the opposing party.
12
3 Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of when
using the 6-series. See also chapter 4 for Warnings and Precautions that are application
specific.
WARNING:
• Federal law (USA only) restricts this device to sale by, or on the order of, a physician or
licensed practitioner. This device should be used only under the continued supervision of
a physician or licensed practitioner.
• Make certain that the unit is electrically grounded by connecting only to a grounded
electrical service receptacle conforming to the applicable national and local electrical
codes.
• Do not operate the unit in an environment of short-wave or micro-wave diathermy use as
this can result in burns beneath the electrodes.
• Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to
minimize this interference by not using other equipment in conjunction with it.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not
operate properly when electrical stimulation is being utilized.
• This equipment is not suitable for use in the presence of flammable anesthetics mixture
with air, oxygen, or nitrous oxide.
• This device should be kept out of the reach of children.
CAUTION:
• Read, understand and practice the precautionary and operating instructions. Know the
limitations and hazards associated with using any electrical stimulation device. Observe
the precautionary and operational decals placed on the unit.
• Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
• Handle ultrasound applicator with care. Inappropriate handling of the ultrasound
applicator may adversely affect its characteristics.
• Inspect ultrasound applicator for cracks which may allow the ingress of conductive fluid
before each use.
• Inspect ultrasound applicator cables and associated connectors before each use.
• Do not operate the 600-series when connected to any unit other than Enraf-Nonius BV
devices.
• This unit should be operated, transported and stored in temperatures between 10 °C
and 40 °C (50 °F and 104 °F), with a Relative Humidity ranging from 10%-90%.
• Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive
amounts of dust, moisture, vibrations and mechanical shocks.
• In the case of ingress of liquids, unplug the unit from the mains supply and have it
checked by an authorized person (see the paragraph on technical maintenance)
• Before administering any treatment to a patient you should become acquainted with the
operating procedures for each mode of treatment available, as well as the indications,
contraindications, warnings and precautions. Consult other resources for additional
information regarding the application of electrotherapy.
13
4 Intended Use: electrotherapy
4.1.1 Indications/Contraindications
Indications:
Contraindications:
• This device should not be used for symptomatic pain relief unless etiology is established
or unless a pain syndrome has been diagnosed.
• This device should not be used on patients with demand-type cardiac pacemakers.
• This device should not be used over cancerous lesions.
• Electrode placements that apply current to the carotid sinus region (anterior neck) must
be avoided.
• Electrode placements that apply current transcereberally (trough the head) must be
avoided.
• Electrode placements that apply current transthoracically (the introduction of electrical
current into the heart may cause cardiac arrhythmias) must be avoided.
Warnings:
• Benefits of TENS currents have not been established for pain of central origin.
• This device is to be used as a symptomatic treatment for pain and has no curative value.
Patients should be cautioned and their activities regulated if pain that would otherwise
serve as a protective mechanism is suppressed.
• The long-term effects of chronic electrical stimulation are unknown.
• Safety has not been established for the use of therapeutic electrical stimulation during
pregnancy.
• Stimulation should not be applied over swollen, infected, or inflamed areas of skin
eruptions e.g., phlebitis, thrombophlebitis, varicose veins, etc.
• See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Precautions:
• Isolated cases of skin rash may occur at the site of electrode placement following long-
term applications. The irritation may be reduced by use of an alternate conductive
medium or an alternative electrode placement.
• Effectiveness of this treatment is dependent upon patient selection.
• See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Adverse Effects:
• Skin irritation and burns beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
14 For pain management the 6-series offers the current waveforms described in paragraph 4.3 -
4.3.9.b.
4.2 Muscle Stimulation
Indications:
Contraindications:
• This device should not be used on patients with demand-type cardiac pacemakers.
• This device should not be used over cancerous lesions.
• Electrode placements that apply current to the carotid sinus region (anterior neck) must
be avoided.
• Electrode placements that apply current transcereberally (through the head) must be
avoided.
• Electrode placements that apply current transthoracically (the introduction of electrical
current into the heart may cause cardiac arrhythmias) must be avoided.
Warnings:
Precautions:
Adverse Effects:
• Skin irritation and burns beneath the electrodes have been reported with the use of
therapeutic electrical stimulation. 15
4.2.2 Current Waveforms
For muscle stimulation the 6-series offers the current waveforms described in paragraphs 4.3.3
- 4.3.6. These waveforms are often applied in combination with a surge program, which consists
of a sequence of exercise and rest periods. Two options are available here:
With the interferential current type a medium frequency carrier frequency is used to pass the low
frequency stimulation (beat) frequency through the skin. The relatively low resistance of the skin
to the carrier frequency contributes to the patient comfort that is often associated with this
current type. Interferential currents are all AC currents without any residual DC components.
Several variations of the interferential current type are known, the following of which are
available in the 600-series:
16
4.3.1.b Isoplanar Vector
The isoplanar vector technique is intended to increase the area where effective
stimulation occurs. Amplitude modulation occurs in the equipment and a special phase
relation between the two channels ensures a 100% modulation depth between the four
electrodes in all positions.
The advantage of this method is that the positioning of the four electrodes to effectively
treat the affected tissue is less critical. The sensation of the Isoplanar vector mode is soft
and equally divided over the treatment area.
With the dipole vector technique the currents from the two electrode pairs are vectorially
summed in the tissue. The effect is that stimulation only occurs into the direction of the
resulting vector, which can be adjusted over a range of 360º. Amplitude modulation
occurs in the equipment and the modulation depth is 100%.
The advantage of this method is that the direction of the stimulation can be adjusted
electronically after positioning the electrodes.
With the automatic dipole technique the dipole vector described above is rotated at an
adjustable speed. If the current amplitude is increased exceeding the motorial threshold,
the tissue will contract and relax rhythmically. The automatic dipole vector current is
ideally suited for areas where mechanical pressure (massage) is not desirable.
17
Parameters:
Carrier frequency, expressed in kHz, is the base frequency of the alternating current.
Beat frequency, expressed in Hz, defines the channel frequency difference in classical
interferential mode and the rate at which the amplitude is internally modulated in the vector
modes.
Frequency Modulation, expressed in Hz, defines a variable frequency range that is summed to
the Beat frequency i.e when the Beat frequency is set to 80 Hz and the Frequency modulation is
set to 40 Hz, the final frequency will vary from 80 – 120 Hz. Frequency modulation is often used
to prevent accommodation to stimulation or to improve patient tolerance.
Modulation Program defines the time and sequence in which the frequency will sweep through
the Frequency modulation range. See for the available Modulation programs fig 13.11– 13.11.3.
Balance defines the difference in current amplitude between the two channels. Only available in
classical interferential mode.
Vector position adjustment defines the angle of the dipole vector with respect to the position
of the electrodes.
Rotation Speed, expressed in s, defines the time elapsed during one revolution of the vector in
automatic dipole vector mode.
The asymmetrical biphasic pulsed current waveform is often used in TENS (Transcutaneous
Electrical Nerve Stimulation) applications. This waveform is characterized by variable phase
duration and variable pulse frequency. Its typical amplitude, duration, and rate of rise and decay
are unequal for each phase with respect to the baseline. The waveform is fully balanced, i.e. the
phase charges of each phase are equal. See fig 13.1 for a graphical representation.
A variation to the standard biphasic asymmetrical pulsed current is the alternating one, in which
the successive pulse phases alternate with respect to the baseline. See fig 13.1.2 for details.
This waveform is also fully balanced.
Parameters:
Phase Duration, expressed in µs, is the elapsed time from the beginning to the termination of
the initial pulse phase. See fig 13.1 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses. See fig 13.1 for details.
Frequency Modulation, expressed in Hz, defines a variable frequency range that is summed to
the Pulse frequency i.e when the Pulse frequency is set to 80 Hz and the Frequency modulation
is set to 40 Hz, the final frequency will vary from 80 – 120 Hz.
Modulation Program, defines the time and sequence in which the frequency will sweep
through the Frequency modulation range. See for the available Modulation programs 13.11 –
18 13.11.3.
4.3.2.b Burst Asymmetrical and Burst Alternating Asymmetrical
The burst biphasic and burst biphasic alternating asymmetrical pulsed currents are variations to
their non burst counterparts, in which the continuous train of pulses is interrupted by pulse
pauses. See fig 13.1.3 and fig 13.1.4 for details. A burst frequency can be set for treating
chronic pains, where the use of continuous stimulation with a low pulse frequency would be too
painful. Each burst lasts for 100ms and the burst rate can be adjusted separately. With this
milder TENS waveform it is easier to exceed the motorial threshold stimulus.
Parameters:
Phase Duration, expressed in µs, is the elapsed time from the beginning to the termination of
the initial pulse phase. See fig 13.1 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses. See fig 13.1 for details.
Burst Frequency, expressed in Hz, defines the repetition rate of bursts of pulses. A burst
consists of a train of pulses. Each burst lasts for 100ms and the number of pulses in a burst
depends on the selected Pulse frequency i.e at a Pulse Frequency of 100Hz, 10 pulses are
available in each burst. Burst mode can not be selected when Frequency modulation is active.
See fig 13.1.3 for details.
4.3.2.c Symmetrical
TENS current pulses can also be used for muscle stimulation applications. Often the
symmetrical biphasic pulsed current waveform is used. See fig 13.1.5 for a graphical
representation. The specified phase duration applies to both pulse phases, which doubles the
amount of available energy with respect to the asymmetrical pulsed current waveform. This
waveform is fully balanced (no residual DC components are present).
Parameters:
Phase Duration, expressed in µs, is the elapsed time from the beginning to the termination of a
pulse phase. The phase duration applies to each pulse phase. See fig 13.1.5 for details.
Phase Interval, expressed in µs, is the elapsed time between the positive and the negative
pulse phase. See fig 13.1.5 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses. See fig 13.1.5 for details.
Frequency Modulation, expressed in Hz, defines a variable frequency range that is summed to
the Beat frequency i.e when the Beat frequency is set to 80 Hz and the Frequency modulation is
set to 40 Hz, the final frequency will vary from 80 – 120 Hz.
Modulation Program defines the time and sequence in which the frequency will sweep through
the Frequency modulation range. See for the available Modulation programs fig 13.11 –
13.11.3.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a for details.
19
4.3.2.d Burst Symmetrical
The burst biphasic symmetrical pulsed current is a variation to its non burst counterpart, in
which the continuous train of pulses is interrupted by pulse pauses. See fig 13.1.3.6 for details.
A burst frequency can be set for treating chronic pains, where the use of continuous stimulation
with a low pulse frequency would be too painful. Each burst lasts for 100ms and the burst rate
can separately be adjusted. With this milder TENS waveform it is easier to exceed the motorial
threshold stimulus.
Parameters:
Phase Duration, expressed in µs, is the elapsed time from the beginning to the termination of
the initial pulse phase. See fig 13.1.5 for details.
Phase Interval, expressed in µs, is the elapsed time between the positive and the negative
pulse phase. See fig 13.1.5 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses. See fig 13.1.5 for details.
Burst Frequency, expressed in Hz, defines the repetition rate of bursts of pulses. A burst
consists of a train of pulses. Each burst lasts for 100 ms and the number of pulses in a burst
depends on the selected Pulse frequency i.e at a Pulse Frequency of 100Hz, 10 pulses are
available in each burst. Burst mode can not be selected when Frequency modulation is active.
See fig 13.1.3 for details.
4.3.3 Premodulated
As with Interferential currents, a medium carrier frequency is used to pass the low frequency
stimulation (beat) frequency through the skin. See fig 13.2 for the current waveform.
‘Premodulated’ implies that amplitude modulation occurs in the equipment, allowing it to be
applied with a single electrode pair.
The Premodulated alternating current is often used where the objective is to strengthen the
muscle and change the distribution of muscle fibers (twitch speed). The Beat frequency is used
to affect the muscle fiber distribution. The optimum carrier frequency for this purpose varies
between 2000 – 4000 Hz.
At a low Beat frequency (up to about 20 Hz) the muscle becomes ‘red’, while at a higher Beat
frequency (up to about 150 Hz) the muscle becomes ‘white’. This can be used to increase the
explosive release of energy in high-jumpers, provided that is supplemented by functional
exercises. The most comfortable tetanic contractions are obtained at a Beat frequency between
40 and 80 Hz.
Muscle stimulation is normally applied with a Surge program, allowing the muscles to rest
between exercise cycles.
Parameters:
Carrier Frequency, expressed in kHz, is the base frequency of the alternating current.
Beat Frequency, expressed in Hz, defines the rate at which the amplitude is internally
modulated.
Frequency Modulation, expressed in Hz, defines a variable frequency range that is summed to
the Beat frequency i.e. when the Beat Frequency is set to 80 Hz and the Frequency modulation
is set to 40 Hz, the final frequency will vary from 80 – 120 Hz.
20
Modulation Program defines the time and sequence in which the frequency will sweep through
the Frequency modulation range. See for the available Modulation programs fig 13.11 –
13.11.3.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a6 for details.
A specific feature of this type of muscle stimulation is that the alternating current is interrupted
50 times per second. This results in a pulse train, comparable to the ‘burst’ in TENS. The total
duration of the pulse train is 20ms, giving a phase duration/phase interval ratio of 1:1. Kots uses
a Burst frequency of 50 Hz, approximately in the middle of the frequency spectrum used to
produce tetanic contraction (40-80 Hz). In addition to the 1:1 ratio, Kots also describes a phase
duration/phase interval ratio of 1:5.
The amplitude should be increased until a powerful contraction is produced (from the motor
stimulation level up to the limit of tolerance). As with all muscle stimulation applications a Surge
program can be used, allowing the muscles to rest between exercise cycles.
Parameters:
Carrier Frequency, expressed in kHz, is the base frequency of the alternating current.
Burst Frequency, expressed in Hz, defines the repetition rate of the bursts.
Burst / Interval Ratio, defines the ratio of the burst length to the interval between the bursts.
The sum of the burst and interval duration is the reciprocal of the burst frequency i.e. with a
burst frequency set at 50 Hz and a burst / interval ratio of 1:5, the burst duration will be 20 * 1/6
= 3.3ms and the interval duration will be 20 * 5/6 = 16.7ms.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a for details.
Parameters:
Alternation mode defines whether the polarity of the wave is automatically alternating or not.
Alternation Sequence, expressed in s, defines the polarity reversal timing in the alternating
mode.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a for details. Surge programs are only available in the non alternating mode. 21
4.3.6 High Voltage
This current type has a twin peak monophasic waveform with a fixed duration of 64 µs between
the two voltage peaks. The amplitude is adjusted in volts rather than in mA. The short rise time
and short duration of each voltage peak (approximately 7 µs) is well suited to nerve stimulation
and efficient discrimination between sensory, motor and pain responses. The very short pulse
duration of high voltage creates a stimulation which is quite comfortable, and one which most
patients can tolerate. The very short pulse duration followed by a very long interpulse interval
eliminates the formation of any appreciable chemical or thermal effects in the tissue. High
voltage is used for stimulating nerves and muscles, causing muscle contractions. Examples for
clinical use are to treat acute or chronic pain, edema absorption and ulcer healing. Muscle
contraction or motor response of isolated muscle groups, superficial or deep, can be easily and
comfortably stimulated. The relative comfort and depth of penetration may be the key for the
usefulness of high voltage stimulation in clinical conditions such as tendon transplants, joint
mobilization and muscle re-education.
Parameters:
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
twin pulses. See 13.5 for details.
Modulation Program defines the time and sequence in which the frequency will sweep through
the Frequency modulation range. See for the available Modulation programs fig 13.11 –
13.11.3.
Alternation Mode defines whether the polarity of the pulses is automatically alternating or not.
Alternation Sequence, expressed in seconds, defines the polarity reversal timing in the
alternating mode.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a for details. Surge programs are only available in the non alternating mode.
The Diadynamic currents were introduced by Bernard(2) and they have won a significant position
in the history of European physiotherapy. They are now somewhat unfairly dismissed as
outdated when compared with Interferential currents or TENS. Diadynamic currents are mainly
used for pain reduction and the improvement of blood circulation.
Bernard uses the term ‘Diadynamic Current’ to refer to a monophase (MF – Monophasé Fixe) or
double-phase (DF – Diphasé Fixe) rectified alternating current. The frequency was directly
derived from the mains supply, resulting in sinusoidal pulses with a duration of 10ms. This
phase time of 10ms will mainly depolarize thick fibers. Stimulation of thin fibers can only be
obtained at higher current amplitudes.
2 Bernard, Pierre D.
La thérapie diadynamique,
Paris, Editions ‘Physio’, 1962.
CAUTION:
• Diadynamic currents are monophasic currents that produce electrolysis by-products.
These by-products can result in burns beneath the electrodes. Always use properly
22 moistened sponge / electrode combinations to absorb these by-products during
treatment. See paragraph 10.1.5 for details.
The following variations are available:
4.3.7.e CPid
Is identical to CP, except that the current amplitude during the MF phase is 12.5% lower than
during the DF phase. See fig 13.6.5 for details. Normally a lower frequency is experienced to be
more aggressive than a higher frequency. CPid prevents this difference in sensation.
Parameters:
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 11.2.11.a for details. Surge programs are only available with MF and DF.
CAUTION:
• The monophasic IG currents are, as their name implies, monophasic currents that
produce electrolysis by-products. These by-products can result in burns beneath the
electrodes. Always use properly moistened sponge / electrode combinations to absorb
these by-products during treatment. See paragraph 10.1.5 for details.
Galvanic current works when combined with the correct ionized/electrically charged solutions,
(i.e. they are ions carrying either a positive or negative electrical charge, or will ionize with
electricity).
This makes it possible to influence the skin's ability to absorb serums into the intracellular
spaces in the dermis. The absorption process is called iontophoresis because the electrical
currents literally carry ions into the tissues between the cells (see fig 12.10.1 for details).
23
CAUTION:
• The Direct Galvanic Current is a monophasic current that produces electrolysis by-
products. These by-products can result in burns beneath the electrodes. Always use
properly moistened sponge / electrode combinations to absorb these by-products during
treatment. See paragraph 10.1.5 for details.
The medium frequency interrupted galvanic current is a monophasic rectangular waveform with
a pulse frequency of 8000 Hz and a duty cycle of 90%. See fig 13.10.2 for details. As opposed
to direct galvanic current, the pulsed waveform provides increased patient comfort.
CAUTION:
• The MF interrupted galvanic current is a monophasic current that produces electrolysis
by-products. These by-products can result in burns beneath the electrodes. Always use
properly moistened sponge / electrode combinations to absorb these by-products during
treatment. See paragraph 10.1.5 for details.
CAUTION:
• Faradic currents are monophasic currents that produce electrolysis by-products. These
by-products can result in burns beneath the electrodes. Always use properly moistened
sponge / electrode combinations to absorb these by-products during treatment. See
paragraph 10.1.5 for details.
Parameters:
Phase Duration, expressed in ms or s, is the elapsed time from the beginning to the
termination of the pulse phase. See fig 12.8.1 and 12.8.2 for details.
Phase Interval, expressed in ms or s, is the elapsed time between succeeding pulse phases.
See fig 12.8.1 and 12.8.2 for details.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 10.2.9 for details.
24
4.3.11 Träbert, 2 – 5 Current
The 2-5 or ‘Ultra-Reiz’ current was introduced by Träbert.1 It is often used to treat headaches
and neck pain. The 2-5 current is a faradic rectangular pulsed current with a phase duration of
2ms and a phase interval of 5ms. These settings are the default settings for the faradic
rectangular current waveform and result in a pulse frequency of approximately 143 Hz. Träbert
offered no explanation for the choice of these parameters. Nevertheless, many workers have
adopted the therapy and it is still applied with success. A remarkable effect is the freedom from
pain which can appear from just the first treatment and which can last for several hours. See fig
12.9 for a graphical representation.
1 Träbert, H.
Ultra-Reizstrom, ein neues therapeutisches Phänomen,
Elektromedizin 2, 1957 (7).
CAUTION:
• Faradic currents are monophasic currents that produce electrolysis by-products. These
by-products can result in burns beneath the electrodes. Always use properly moistened
sponge / electrode combinations to absorb these by-products during treatment. See
paragraph 10.1.5 for details.
Parameters:
Phase Duration, expressed in ms or s, is the elapsed time from the beginning to the
termination of the pulse phase. The default setting is 2ms. See fig 12.9 for details.
Phase Interval, expressed in ms or s, is the elapsed time between succeeding pulse phases.
The default setting is 5ms. See fig 12.9 for details.
To achieve a better understanding of the excitability of nerves and muscles, we must consider
the strength (amplitude) an de duration (ON time) of the applied current, since a relation exist
between the strength and the duration necessary to elicit a threshold response from nerve and
muscle. By varying the strength and duration of the electrical stimulus, it is possible to plot a
curve called the strength-duration (SD) curve that gives a graphic illustration of the excitability of
nerve and muscle. The strength-duration curves for nerve muscle are very characteristic and
are readily reproducible.
Although the shape of the SD curve is similar for both nerve and muscle, the position of the
curve on the graph will vary according to the innervation status of the muscle (innervated,
partially denervated, or completely denervated).
Two important numerical values that can be determined from the SD curve are the rheobase
and the Chronaxie.
The rheobase (threshold) is the minimal strength of an electrical stimulus of infinite duration that
is capable of exciting a tissue (nerve or muscle).
Chronaxie is the duration of an electrical stimulus of twice the rheobase value that will cause a
minimal response (ie, muscle twitch).
The Chronaxie of an intact nerve (healthy, innervated muscle) is much lower (approximately
0.03 ms) that that of a denervated muscle (approximately 10 ms). These values illustrate the
fact that healthy, innervated muscle is much more excitable than is unhealthy, denervated
muscle. Therefore, healthy, innervated muscle will respond best to a stimulus of sufficient
amplitude and of short duration, whereas an impulse of long duration and of greater amplitude is
required to effectively stimulate denervated muscle. Therefore, the SD curve illustrates the
relationship between the time (duration) that an electrical stimulus required to produce a
threshold response (muscle twitch)
25
5 Intended Use Ultrasound therapy and StatUS
5.1 Ultrasound
Ultrasound is a mechanical energy consisting of high-frequency vibrations applied by means of
an ultrasound applicator. These vibrations pass through the tissue of the body and are gradually
absorbed and transformed into heat. The resulting temperature increase triggers biological
changes to occur in the tissue for the relief of pain, relaxation of muscle spasms and reduction
of joint contractures.
Indications:
• Ultrasound is indicated for conditions that benefit from the application of deep heat: relief
of pain, muscle spasms and joint contractures. The objective of therapeutic ultrasound in
the treatment of selected medical conditions associated with the chronic and sub chronic
conditions of bursitis/capsulitis, epicondylitis, ligament sprains, tendinitis, scar tissue
healing and muscle strain is to reduce pain.
Contraindications:
• The established contraindications to heat therapy itself.
• In an area of the body where a malignancy is known to be present.
• Over or near bone growth centers until bone growth is complete.
• Over the thoracic area if the patient is using a cardiac pacemaker.
• Over a healing fracture.
• Over ischemic tissues in individuals with vascular disease where the blood supply would
be unable to follow the increase in metabolic demand and tissue necrosis might result.
• In the presence of metal implants of any type.
• Patients with sensory loss on the area to be treated.
• The gonads or to the developing fetus.
• The heart.
• The brains.
• The testicles.
• The eyes.
• Facial sinus as this exposes the eyes to the same hazards.
• Ultrasound should not be used on unconscious patients.
Relevant Hazards:
• Use of ultrasound in treating areas above the shoulders may pose relevant hazards.
While it is recognized that certain specific conditions involving the eyes can and have
been treated by specialists qualified by training, knowledge and experience to administer
such treatments, such application carries with it recognized hazards of applying heat to
the eyes.
• Treatment of the facial sinus exposes the eyes to the same hazards.
• Treatment of the thyroid, as well as lymph nodes in the neck, may expose the patient to
26 as yet undetermined effects inasmuch as the safety of such treatments has not yet been
established.
Potential Adverse Effects:
• Cataracts.
• Male sterility.
• Enhanced drug activity.
• Thermal stress.
5.1.2 Parameters
Ultrasound Frequency, expressed in MHz, is the frequency of the ultrasound waves. The
ultrasound frequency determines the penetration depth, which has the largest value at 1 MHz.
The ultrasound frequency can be set at 1 MHz or 3 MHz.
Duty Cycle, expressed in %, defines the ratio of the pulse duration to the pulse repetition time.
Ultrasound can be applied in pulsed or in continuous mode. When the Duty Cycle is set to
100%, the apparatus operates in continuous mode.
Effective Radiation Area (ERA) expressed in cm², defines the cross-sectional area of the
ultrasound beam (See technical specifications for details). The Effective Radiation Area is fixed
and defined by the size of the ultrasound applicator.
Ultrasound Power is the ultrasound output expressed in W. The ultrasound output display can
be toggled between W and W/cm². In pulsed mode the power during the pulse is displayed. The
time averaged power can be obtained by multiplying this value with the Duty Cycle.
Ultrasound Amplitude, expressed in W/cm², is the quotient of Ultrasound Power and Effective
Radiation Area. The ultrasound output display can be toggled between W and W/cm². In pulsed
mode the Amplitude during the pulse is displayed. The time-averaged Amplitude can be
obtained by multiplying this value with the Duty Cycle.
27
Duty Cycle Modulation
Duty cycle can be described as the proportion between the duration of the pulse and the
duration of the interval. The duty cycle is expressed in a percentage (%). The device is working
in a continuous modus when the duty cycle is 100%.
Duty cycle modulation implies that the duty cycle fluctuates automatically in a flowing pattern.
The modulation is characterised by a fixed duration of a total of 12 seconds, during which time
the (pre) set duty cycle goes to 5% and back again. So, if the duty cycle is set at 50%, then it
will gradually drop to 55 in 6 seconds and then increase again from 5% to 50% in 6 seconds as
well. And so the modulation actually ensures that the pulse duration is automatically reduced or
increased.
Duty Cycle Modulation with text 'example of the modulation when Duty Cycle is set at 50%’
Amplitude Modulation
Amplitude Modulation involves varying the ultra-sound intensity. This form of modulation is also
characterised by a rhythmic period of 12 seconds. The intensity (W/cm2) is set at 100%. The
intensity will gradually drop from 100% to 85% in the first 6 seconds, after which it will increase
back up to 100% in the next 6 seconds.
2
Amplitude Modulation with text ‘example of the modulation when intensity is set at 1.0 W/cm
Both forms of modulation can be switched on and off independent of one another. This (de)
activation is achieved by selecting the desired function on the parameter display (see page ….).
The standard (factory) setting for both modulation forms is ‘modulation on’.
When both modulations are activated, they run synchronous (in phase) and they start ‘from high
to low’. The difference between the minimum and the maximum level of the effective output is
the greatest in this way.
!CAUTION:
StatUS-therapy, on the other hand, makes use of two special forms of modulation that ensure
that the peaks in intensity in the ultra-sound bundle are strongly reduced, diminishing the risk of
cavitation and preventing the occurrence of ‘hotspots’.
28
6 Intended use Vacuum
The continuous and pulsed vacuum module allows vacuum electrodes to be positioned quickly
and easily. Furthermore, it is extremely simple to switch between treatment with vacuum
electrodes and treatment with flexible rubber electrodes. This makes the vacuum module an
ideal aid for electrode placement.
Vacuum electrodes make good contact with the skin, which means that effective use is made of
the whole electrodes area. The massage effect resulting from the pulsed vacuum ensures a
good blood through the skin under the electrodes. This reduces the resistance of the skin and
increases he effectiveness of the stimulation current.
7.1 Parameters
Sensitivity, allows changing the sensitivity from the measurement range. For surface EMG the
read-out is in µV and the pressure read-out is in hPa.
Shift, this parameter makes it possible to zoom-in on a specific area in the graphic to have a
better feedback for the patient.
Threshold can be used as target function in feedback therapy. In combination with electro
stimulation the threshold triggers the start, or end of the stimulation.
Graph, here you can select the graphical feedback on the screen. There are 2 feedback
possibilities, by bar or curve. The colours are not changeable.
Sound, is the acoustic feedback during the treatment. Several settings are possible.
Record, this parameter need to be use as start en registration of the treatment.
Analyze, at the end of the treatment time or after the use of the Stop you can analyze the whole
session. Select the icon ef in the analysis menu to move the cursor in the curve. The value
from that position will be displayed on the screen. To zoom-in on that area you can use the loop
icon.
Report, here you can find the result of the last session in figures.
Cycles, here you can set the repetitions of the training. This parameter is only applicable in
Myofeedback mode; Excerice/ Rest and Template and the Myofeedback + Stimulation mode.
Template, select here the curve type. There are six different training curves available .
29
7.2 Indications/Contraindications and Adverse Effects for Myofeedback
Indications
• Loss of coordination (voluntary muscles)
• Craniomandibular dysfunction
• Tension headache / Migraine
• Stress-related disorders
• Low-Back Pain
• Respiratory diseases
• Orthopedic, post-traumatic and post-surgical disorders
• Peripheral nerve lesions
• Mimic (Facial) Rehabilitation
• Pelvic Floor Reeducation (Incontinence)
Contraindications
Because Myofeedback therapy does not “do” anything to the body, few contraindications exist.
Myofeedback therapy is not recommended for persons with severe psychosis, depression, or
obsessional neurosis, nor for debilitated patients or those with psychopathic personalities.
However, because resulting functional improvements can require strenuous physical effort,
individuals interested in Myofeedback may need to be aerobically fit.
30
8 Package Contents
• Remove the 6-series unit and any additional items ordered from the carton and inspect
for damage that may have occurred during shipment.
• Place the unit on a desk or EN-Car. Ensure that there is sufficient air flow below the unit
(do not place the unit on a table-cover).
• If necessary, adjust the adjustable foot [21], so that the unit does not wobble.
• Remove the 6-series unit and any additional items ordered from the carton and inspect
for damage that may have occurred during shipment.
• Place the vacuum unit on a desk or EN-Car.
• If necessary adjust the vacuum unit's adjustable foot [25], so that the vacuum unit does
not wobble.
• Place the main unit on top of the vacuum unit.
• If necessary adjust the main unit's adjustable foot [21], so that the main unit does not
wobble.
• Push the vacuum hose [23] over the hose nipples on both units.
• Carefully lift the main unit at the front and insert flat cable [17] into connector [18].
• Insert the mains cable into socket [20] and connect it to a wall socket. Status indicator
LED [14] indicates that the unit is connected to the mains supply.
!CAUTION:
• Do not place the unit in a location where the power cord could be tripped over or
pulled out during treatment.
• Do not attempt to use the unit if it is not properly grounded. Make certain that the
unit is electrically grounded by connecting it only to a grounded electrical service
receptacle conforming to the applicable national and local electrical codes
regarding medical environments.
• The unit will initialize. This may take a while. During initialization LED [14] blinks yellow.
• At the end of the initialization the unit enters standby mode. LED [14] is now
continuously yellow.
• Start the unit by pushing the standby button [19] 1.
• The unit starts by executing the self test, during which LED [14] blinks green.
• At the end of the self test the unit enters the Home menu and is ready for use. LED [14]
is now continuously green.
• When you have finished treatments push the standby button [19] 1 again to leave the
unit in standby mode.
1
When you push the standby button for more than two seconds, the unit will completely
reinitialize and enter standby mode.
33
10 Application Notes
10.1 Electrotherapy
!CAUTION:
• Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
• To prevent infection, electrodes and sponge pads should not be used on broken skin.
We recommend using the flexible rubber electrodes in combination with the supplied sponge
pads. When properly moistened, the sponge pads ensure low impedance between the skin and
the stimulator during treatment and they are easily cleaned afterwards. Follow the guidelines
below when using these electrodes.
• Prior to initial use thoroughly rinse the sponge pads in warm tap water to remove the
impregnating agent.
• Before application saturate the sponge pads with tap water. In areas with soft tap water
use a saline solution instead. This will improve electrical conduction.
• The supplied sponge pads have three layers. With AC currents, apply one sponge layer
between the skin and the electrode for minimum resistance.
• With DC currents, apply two sponge layers between the skin and the electrode. Two
layers provide more absorbing capacity for electrolysis by-products.
• Fix the electrode/sponge pad assembly to the patient using the supplied fixation straps.
Depending on the electrode size, use two or three wraps to maximize the contact
surface. See the illustrations below.
Wrong application of fixation straps, resulting Correct application of fixation straps, resulting
in poor electrical conductivity. in good electrical conductivity.
• Use the stimulator in the Constant Current (CC) mode. This will maintain the set current
amplitude, even when the impedance of the sponge pads increases during treatment
caused by water evaporation.
• Keep the sponge pads well moistened during treatment, especially with DC currents. If
the current display starts blinking, it is an indication of poor electrical contact.
• After use clean the sponge pads as described in the User Maintenance instructions.
34
CAUTION: Do not use electrodes on open wounds
35
10.1.3 Vacuum electrodes
There is a choice of large and small electrodes. The areas of the electrodes correspond to those
of the 4 x 6cm and 6 x 8cm flexible rubber electrodes. The vacuum electrodes are sufficiently
flexible to ensure optimum contact with the skin, but rigid enough to prevent any changes in the
contour of the part being treated, allowing full advantage to be taken of the massage effect of
the pulsed vacuum.
Keep the sponge pads well moistened during treatment.
After use clean the sponge pads as described in the User Maintenance instructions.
Self-adhesive electrodes have higher series impedance then flexible rubber electrodes. This
can cause the stimulator to terminate treatment at higher current amplitudes. When this occurs
it is recommended to continue the treatment with flexible rubber electrodes, combined with
properly moistened sponge pads.
Self-adhesive electrodes are not recommended for use with currents that contain a DC
component.
Electrolysis occurs under the electrodes when current types with a DC component are applied.
Because the greatest concentration of electrolytic by-products caused by ion migration occur
under the electrodes, we recommend the use of the supplied sponges to keep the effects to a
minimum. Make sure that the sponges are kept well moistened and place the thick side of the
sponge between the flexible rubber electrodes and the patient.
In the particular standard for Electrical Nerve and Muscle Stimulators, IEC 60601-2-10, it is
recommended not to exceed a current density of 2 mA r.m.s. / cm², otherwise skin irritations or
burns can occur. For current types that contain a DC component we recommend not to exceed
a current density of 0.2 mA / cm².
For a precise calculation of the r.m.s. value of a pulsed current waveform the following formula can be used:
6
IRMS = Ipeak √ ( Phase duration [µs] * pulse frequency [Hz] * 10 )
For symmetrical TENS currents, the Phase duration should be multiplied by 2. The value of the peak current Ipeak
can be taken from the current display.
Electrodes should be placed with care, ensuring good electrical contact over the entire electrode
surface.
36
10.1.7 Connection and disconnection reactions
Constant Current (CC) output characteristics may cause unpleasant connection and
disconnection reactions if the electrodes are not securely placed or lose contact with the skin.
Make sure the current amplitude is set to 0 mA when you apply or remove the electrodes. Use
the Constant Voltage (CV) output mode with dynamic electrode applications.
10.2 Ultrasound
The ultrasound applicator has a contact control function that suspends treatment when the
acoustical contact with the body drops below a certain level (see paragraph 14.1). The indicator
light on the applicator is turned on to signal this situation, the ultrasound Amplitude display will
start blinking and the treatment timer will stop counting down. During this situation the applicator
emits a small amount of energy to sense restoration of acoustical contact. You may experience
this when the applicator only partially contacts the body. When contact restoration is sensed the
treatment is resumed at the set Amplitude.
The contact control function does not work at Amplitudes below 0.2 W/cm².
To ensure efficient transfer of energy, a contact medium is required between the ultrasound
applicator and the body. Air causes virtually total reflection of the ultrasound energy. The best
medium for the transfer of ultrasound energy is a gel.
• The gel should be applied to the part of the body to be treated and then spread out with the
ultrasound applicator.
• Never apply the gel to the ultrasound applicator. The applicator will register this as acoustical
contact and may emit ultrasound energy, which could damage the applicator.
If the body surface is very irregular, making it difficult to obtain good contact between the
ultrasound applicator and the body, or if direct contact must be avoided (e.g. due to pain), the
affected area may be treated under water (subaqual method). The water should be degassed
(by previous boiling) in order to prevent air bubbles arising on the ultrasound applicator and the
body.
• Check the patient for contraindications. See section 5.1.1 for details.
• Test the warmth sensibility of the treatment area.
• To optimize ultrasound transmission, clean the skin of the treatment area with soap or a 70%
alcohol solution.
• Strong hair growth has to be shaved.
• The ultrasound applicator has to be moved constantly, also with the semi-static method.
During treatment the displayed ultrasound Amplitude can vary around the set value, caused
by fluctuations in acoustical coupling.
• Ask the patient regularly for his/her findings. If necessary the treatment will have to be
adapted. The Amplitude can be reduced or the continuous mode can be changed to pulsed
mode or vice versa. 37
• When there are signs that the ultrasound transmission is bad, add more contact gel or
spread it with the applicator.
38
CAUTION:
• The ultrasound applicator is a precision instrument. Great care has been taken during
the development and in production to obtain the best possible beam characteristics.
Rough treatment (jarring or dropping) can adversely affect these characteristics, and
must therefore be avoided.
10.3 StatUS
A special gel cushion (gel pad) is placed on the head for a proper transfer of the ultra-sound
energy. Do not use regular (fluid) Sonogel, as it is sucked into the vacuum pump.
The gel pad is held in position using a fixation. The vacuum pressure ensures that the head can
be placed on the body quickly and easily and that the head remains in contact with the body
surface.
39
10.3.2 Applying the fixation
Press the fixation included across the treatment head (see photograph hereunder)
Make sure that the ridge on the inner side of the fixation [A] falls in the groove of the treatment
head [B]
You are also referred to chapter 10.3 for instructions on operating the device.
Warning: only use the original Enraf-Nonius gelpads! Do not use liquid gel as this will be
sucked into the vacuum tubes and pump, causing malfunction!
Any warranty claim will be rejected if liquid gel residue if found in any of these components.
Warning: since the StatUS-applicator transfers ultrasound energy into the tissue at a most
efficient and effective way, we advise you to use lower intensity settings than the usual intensity
settings for 'traditional' (semi-stationary or dynamic) ultrasound.
40
10.4 EMG
10.4.1 Connections
E1 : EMG channel 1
REF : Reference cable
E2 : EMG channel 2
P : Pressure channel
!CAUTION
• Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
41
11 Operating Instructions
42
!CAUTION:
• Connection of accessories other then the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted. For combined applications only use Enraf-Nonius type BF
equipment. The very low leakage current of this type of equipment ensures absolute
safe therapy.
• The ultrasound applicator is a precision instrument. Great care has been taken during
the development and in production to obtain the best possible beam characteristics.
Rough treatment (jarring or dropping) can adversely affect these characteristics, and
must therefore be avoided.
• Connection of accessories other then the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
• The selection for activating the output is in the ultrasound menu
43
11.2.2 Navigation and display organization
The display is organized as a spreadsheet of four sheets, one for each channel. The channels
refer to the application modules accessible at the front of the unit. A sheet can be selected with
the channel selection button [1, 2, 3, 4] and shows the parameters belonging to that channel.
Each sheet has a tab, in which the output amplitude of that channel is displayed, as well as
other important information, such as the remaining treatment time. The tab information is
continuously visible.
Each sheet contains a list of therapy parameters. A parameter can be selected with the central
controller [5] and opened by pressing the confirmation button [6]. When opened, a pop-up
window appears, in which the parameter can be changed, using the central controller [5].
Pressing the confirmation button [6] again takes you back to the parameter list. To adjust the
output amplitude, first press the channel selection button [1, 2, 3, 4] and then adjust the
amplitude with central controller [5]. Pressing the confirmation button [6] takes you back to the
parameter list.
For some applications, such as interferential therapy and combination therapy, two adjacent
channels can be linked. Linked channels are indicated by a combined tab. The tab halves show
the output amplitude of each channel, while the parameters on the remainder of the sheet apply
to both channels.
When you turn on the unit, you will first enter the Home menu. In the Home menu none of the
channels are selected. The Home menu provides a structured access to all therapies available
within the unit, with appropriate parameter defaults. Just select a menu item using the central
controller [5] and press the confirmation button to navigate to the next screen. You can navigate
back to the previous screen by directing the cursor to the back arrow at the top of the screen
and pressing the confirmation button [6]. Anywhere in the navigation, you can jump back to the
Home menu, by pressing the Assist button [7] and selecting the Home entry in the pop-up list
that appears.
44
11.2.4 Therapy Wizard
The Therapy Wizard guides you Í Therapy Wizard
through a wide range of treatment
suggestions. You select either Body
Part or Application. Under the Body Part
personal protocols you can retrieve
your personal stored protocols. Applications
• Select the desired choice with Protocol List
the central controller [5] and
enter it with the confirmation Personal Protocols
button [6]
45
The display is showing the Í Pain Management 1+2
select protocol and pre-
programmed parameter (Sub)luxation acromioclavicular High
setting.
Use the Assist button [7]
Premodulated
for: Treatment Time 20:00
• Therapy information Carrier Frequency 6.0 kHz
• Electrode placement by
picture Beat Frequency 100 Hz
• Storing Frequency Modulation 0 Hz
• Pause
Modulation Program 1/1 s
It’s always possible to Surge Program
change parameter setting.
► 19:50
15.0 mA 14.3 mA
11.2.5 Electrotherapy
• Select electrotherapy with the central controller [5] in the main menu.
• Enter the selection by pushing the confirmation button.
• For easy and simple access to Current Waveforms we divided them in different groups.
o Pain management here you can find all Current Waveforms for pain
management
o Muscle stimulation here you can find all Current Waveforms for muscle
stimulation
o Quick access to all Current Waveforms
o Diagnostics here you enter the diagnostic part to generate S/D curves
46
• Select the desired application
with the controller [5] and enter
Í Home
with the confirmation button [6] Electrotherapy
Pain Management
Muscle Stimulation
All Current Waveforms
Diagnostics
47
11.2.5.a Diagnostics Í Electrotherapy
• Select Diagnostics
application with the Pain Management
controller [5] and enter
with the confirmation Muscle Stimulation
button [6] All Current Waveforms
• Select new session
• Select channel 1 or 2. Diagnostics
Channel 2 offers
additional to channel
one the use of a
Search Probe.
• Connect the special
probe on connector
[10]
48
11.2.5.a.1 Rheobase/ Chronaxie
mA
10.0 mA
49
• Push the confirmation Í Diagnostics 2
button [6] to accept and
to see the complete Rheobase / Chronaxie
curve Rheobase
• Return to the previous
menu via the central
controller [5] 500 ms
• Select Report to see
the results by figures.
Chronaxie
1000 µs
10.0 mA
mA
51
• Select report Í Diagnostics 2
• You can store the
results by pushing the Report
assist button [7] Rheobase 1.6 mA
• Select store
• Push the confirmation Chronaxie 10 ms
button [6]. Effective Phase Duration 1000 ms
• The results will be
stored under: Accommodation Threshold 4.2 mA
o Diagnostics Accommodation Quotient 2.6
o Stored sessions
Optimal Phase Duration 30.0 ms
Amplitude 2.8 mA
A0:00
0.00 W/cm²
52
• Changing parameters Í Ultrasound 3
• Select the parameter
with the central
controller [5] and enter Treatment Time 06:00 min
with the confirmation
button [6] Applicator
• Adjust the setting in the Ultrasound Frequency 1 MHz
pop-up screen
• The range of the Duty Cycle 100 %
parameter is showing Pulse Frequency 100 Hz
in the pop-up screen.
• Push the confirmation Units W/cm²
button [6] to return
• Select other parameter
or start the therapy with A06:00
the intensity
1.50 W/cm²
A0:00
0.00 W/cm²
53
• Using the central Í Combination Therapy 2
controller [5], select a
parameter.
• Enter the selection with Premodulated
the confirmation button
[6] Treatment Time 7:00
• Adjust the parameter in Carrier Frequency 4.0 kHz
the pop-up with the
central controller [5] Beat Frequency 80 Hz
• The range of the Frequency Modulation 0 Hz
parameter is shown in
the pop-up screen. Modulation Program 1/1 s
• Push the confirmation Output Mode CV
button to return.
07:00 A
0.0 mA 1.50 W/cm²
A0:00
0.00 W/cm² 0
A0:00
0.00 W/cm² 0
54
• Push the selection Í StatUS 3+4
button[4] and adjust the
pressure with the
central controller [5] Treatment Time 0:00
Ultrasound Applicator B
Ultrasound Frequency 1 MHz
Duty Cycle 20 %
Duty Cycle Modulation
Amplitude Modulation
Pulse Frequency 100 Hz
B7:00
0.00 W/cm² 45
Warning: only use the original Enraf-Nonius gelpads! Do not use liquid gel as this will be
sucked into the vacuum tubes and pump, causing malfunction!
Any warranty claim will be rejected if liquid gel residue if found in any of these components.
Warning: since the StatUS-applicator transfers ultrasound energy into the tissue at a most
efficient and effective way, we advise you to use lower intensity settings than the usual intensity
settings for 'traditional' (semi-stationary or dynamic) ultrasound.
55
11.2.9 Vacuum adjustment via Assist button
Electrotherapy
• Push the Assist
button [7]
• Select in the pop-up Assist
with the central
controller [5] Vacuum Stop
• Push the confirmation Unlink Channels
button to return.
Home
Store
Vacuum
15:00
0.0 mA 0.0 mA
15:00
0.0 mA 0.0 mA
15:00
0.0 mA 0.0 mA
56
11.2.9.a Vacuum pulsed mode
The underlining reason for vacuum pulsation is creating a massage effect during a treatment
session. This is achieved by rhythmically varying the amount of suction under the electrode
cups. To allow pulsation the range must be set between 10-30%. Ideally the setting should be
between 50-70%. The minimum vacuum setting that allows pulsation is 15. If during treatment
the vacuum setting is reduced below 15 then the pulsation range will also automatically be
reduced to insure that the amount of suction does not drop below the minimum needed for
preventing the cup to fall off. The pressure under the cup will rhythmically pulse between the
vacuum setting and the selected range. The rhythm cycle can be adjusted with the parameter
“Hold time” and can be adjusted from 0 to 2.5 seconds in steps of 0.5 seconds.
The hold time setting is applied when the lower vacuum limit is reached. (Please see par.12.13)
15:00
0.0 mA 0.0 mA
57
11.2.9.c Default Setting Vacuum Module
Frequent users of vacuum therapy can change the default setting for this module. Go to the
System Setting to change the default settings for the default vacuum Pressure and the electrode
selection.
To activate the new default settings switch the unit on/off with the reset button.
1. Place the reference electrode on the skin and connect it with the unit.
2. Place the EMG electrodes on the skin and connect these with the unit.
!CAUTION
• Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
58
• Select Myofeedback Í Feedback Therapy
with the central
controller [5] and enter
with the confirmation Myofeedback
button [6].
Myofeedback + Stimulation
Pressure
Pressure + Myofeedback
Stored Sessions
59
• Treatment and Í Myofeedback 4
registration runs
Continuous – Record
Note!
Following parameters are
adjustable during the
treatment:
• Sensitivity
• Shift
• Threshold
15:00 15:00
0.0 mA 0.0 mA
1. Turn on the MyoComBox (make sure that the Bluetooth antenna is in one of the USB
connections of the MyoComBox).
2. Go to the “System Settings” via the Home menu. Select the MyoComBox and then
select “Search.” The device will show the serial numbers of the available
MyoComBox(es) in a list. Connect the device to the MyoComBox of your choice by
selecting the serial number from the list. Check that the serial number corresponds to
the number on the left in the LCD screen of the MyoComBox.
3. Set the time and date of the MyoComBox.
4. Designate a system name if desired. This name will be displayed in the selected
MyoComBox.
60 In addition to these settings there is also the option of setting a notch filter. The notch filter
removes artifacts from the EMG signal that are the result of the power supply frequency. Set the
notch filter to 60 Hz if the power supply frequency is 60 Hz. The default is 50 Hz (this is the
power supply frequency in most countries). It is also possible to completely turn off this filter, but
we do not recommend this.
Once the measurement has been completed the data can be exported from the MyoComBox to
the USB memory stick. To do this go to the analysis screen, press on the orange “Assist” key
and select “Save.” Then select the file from which you want to write the data to the USB memory
stick.
When you then insert this USB memory stick into your computer you can open the data files.
You can import them as a .txt file (text file with tab-separated data) or create a report from the
data with the aid of the MyoComBox Data Viewer by Enraf-Nonius (article number1600840). It is
easy to make a standard report with this program; in addition, up to five measuring sessions can
be compared. The program can be downloaded from www.enraf-nonius.com.
61
• Change the value with Í Myofeedback 4
the central controller [5]
and push the Continuous - Settings
confirmation button [6]
to return
Note!
During this setting the
measurement is active
without any registration
Í Myofeedback 4
Sensitivity setting during
treatment. Continuous - Record
62
• Change the value with Í Myofeedback 4
the central controller [5]
the line will move Continuous - Settings
during the setting.
• Push the confirmation
button [6] to return
Note!
During this setting the
measurement is active
without any registration
63
11.2.10.e Exercise / Rest
Note!
• Stop the treatment via
the assist button
• Use the pause under
the assist button to
interrupt the treatment.
Use the same button to
start again.
Note!
• Stop the treatment via
the assist button
• Use the pause under
the assist button to
interrupt the treatment.
Use the same button to
start again.
Shift is a special tool only available in the Myomed 6- series. The function of this parameter is to
zoom-in on a specific area in the graphic to have a better feedback for the patient. This is useful
for patient with muscle Hypertonia.
Note! Í Myofeedback 4
• The shift range is
linked to the Sensitivity Continuous - Shift
setting.
1. Place the reference electrode on the skin and connect it with the unit.
2. Place the EMG electrodes on the skin and connect these with the unit.
!CAUTION
• Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
66
• Using the central Sonopuls 692 M
controller [5], select
Feedback Therapy in Home
the main menu. Therapy Wizard
• Enter the selection with
the confirmation button Electrotherapy
[6]. Ultrasound Therapy
Combination Therapy
Feedback Therapy
System Settings
11.2.10.i Alternating
67
• Select a current wave Í Feedback Therapy 4
form with the central
controller [5] and enter Myofeedback + Stimulation
with the confirmation Premodulated
button [6]
Russian Stimulation
Biphasic Pulsed Current (TENS)
Faradic Current
Diadynamic Current
High Voltage
Note!
0.0 mA 0.0 mA
Previous to the start via record we advise to adjust the stimulation level first.
Push the button [1] to activate the stimulation setting for channel 1 and adjust with the central
controller [5].
The current indications for the EMG channels will be displayed as usual in current channel 1
and 2. The electrode indication will change to E1 for channel 1 end E2 for channel 2
Go to record to start the treatment.
68
White area is the Exercise Í Myofeedback + Stimualtion 4
time
Green area is the Rest Alternating - Record
time
Orange is the stimulation
time; in that field is during
the stimulation time no
extra feedback, only the
colour background
Note!
• Stop the treatment via
the assist button
• Use the pause under
the assist button to E1 • 0:00 E1 f01:05
interrupt the treatment.
Use the same button to 0.0 mA 0.0 mA 65 µV
start again.
In this mode the stimulation will be activated automatically when the contraction is above the
threshold during the exercise time. The stimulation time will be followed by a rest time.
E1 • 0:00 E1 10:00
0.0 mA 0.0 mA
69
• Select a current wave Í Feedback Therapy 4
form with the central
controller [5] and enter Stimulation above Threshold
with the confirmation Premodulated
button [6]
Russian Stimulation
Biphasic Pulsed Current (TENS)
Faradic Current
Diadynamic Current
High Voltage
E1 • 0:00 E1 10:00
0.0 mA 0.0 mA
• Using the central Í Myofeedback + Stimulation 4
controller [5], to select
a parameter and push Stimulation above Threshold – Settings
the confirmation button Rest Time 0:05
[6].
Exercise Time 0:05
Adjust: Stimulation Time 0:05
• Rest Time in sec
• Exercise Time Cycles 5
• Stimulation Time Sensitivity 200 µV
• Cycles (amount of
repetitions) Shift 0 µV
• Sensitivity Threshold 80 µV
• Threshold
• All stimulation E1 • 0:00 E1 01:15
parameters. 0.0 mA 0.0 mA
Note!
Previous to the start via record we advise to adjust the stimulation level first.
Push the button [xx] to activate the stimulation setting for channel 1 and adjust with the central
controller [5]
70
White area is the Exercise Í Myofeedback + Stimualtion 4
time
Green area is the Rest Stimulation above Threshold - Record
time
Pink is the stimulation
time, in that field is during
the stimulation time no
extra feedback, only the
pink background
Note!
• Stop the treatment via
the assist button
• Use the pause under
the assist button to E1 • 0:00 E1 f01:05
interrupt the treatment.
Use the same button to 7.0 mA 0.0 mA 65 µV
start again.
In this mode the stimulation will be activated automatically when the contraction is below the
threshold during the exercise time. The stimulation session will always be followed by a rest
time.
71
• Select a current wave Í Feedback Therapy 4
form with the central
controller [5] and enter Stimulation below Threshold
with the confirmation Premodulated
button [6]
Russian Stimulation
Biphasic Pulsed Current (TENS)
Faradic Current
Diadynamic Current
High Voltage
Note!
Previous to the start via record we advise to adjust the stimulation level first.
Push the button [xx] to activate the stimulation setting for channel 1 and adjust with the central
controller [5]
72
White area is the Exercise Í Myofeedback + Stimualtion 4
time
Green area is the Rest Stimulation below Threshold - Record
time
Orange is the stimulation
time, in that field is during
the stimulation time no
extra feedback, only the
pink background
Note!
• Stop the treatment via
the assist button
• Use the pause under
the assist button to E1 • 0:00 E1 f01:05
interrupt the treatment.
Use the same button to 10.0 mA 0.0 mA 65 µV
start again.
11.2.10.l Pressure
!CAUTION
• Connection of accessories other than the ones specified by the manufacturer can
adversely affect the safety of the patient and correct functioning of the equipment, and is
therefore not permitted.
73
• Select Pressure with Í Feedback Therapy
the central controller [5]
and enter with the
confirmation button [6]. Myofeedback
Myofeedback + Stimulation
Pressure
Pressure + Myofeedback
Stored Sessions
74
• Treatment and Í Myofeedback 4
registration runs
Continuous – Record
Note!
Following parameters are
adjustable during the
treatment:
• Sensitivity P
• Shift P
• Threshold P
75
Select the cursor ef and Í Pressure 4
push the confirmation
button [6]. Continuous – Analysis
76
11.2.10.o Report
Í Pressure 4
Go to report with the Continuous - R
central controller [5] and
push the confirmation Zero
button [6] Threshold P 0.0 hPa
Graph
Sound
Record
Analyze
Report
0:00 • 0:00 P 0:00
0.0 mA 0.0 mA
77
11.2.11 System Settings
Surge programs allow you to program sequential increases and decreases in current amplitude.
See fig 13.12 for details. Surge programs should not be confused with protocols:
The surge program options that are available depend on whether the 600-series is operating
with independent or linked channels.
With independent channel operation the surge programs run independently over both channels.
They can independently be enabled and their parameters can individually be set. When the
current channels are linked, the surge programs are also linked, which implies that their
parameters have identical values. The following options are available in this case:
• Synchronous
• Asynchronous
• Alternating
In the Synchronous mode the surge pattern runs synchronously on both channels.
In the Asynchronous mode a delay time can be set between the start of the surge program on
channel 1 and channel 2.
In the Alternating mode the stimulation period (ramp-up + hold + ramp-down) on one channel
coincides with the rest period on the other channel.
To start the program push the Assist button and deactivate the pause symbol by selecting
Continue with the central controller and the confirmation this with confirmation button [6].
Parameters:
Ramp-up time, expressed in s, defines the time in a surge program during which the current is
increased from 0 to the adjusted level. See fig 13.122 for details. The ramp-up time can be
adjusted in increments of 0.1s.
Hold time, expressed in s, defines the time in a surge program during which the current is kept
at the adjusted level. See fig 13.122 for details. The hold time can be adjusted in increments of
1s.
Ramp-down time, expressed in s, defines the time in a surge program during which the current
is decreased from the adjusted level to 0. See fig 13.122 for details. The ramp down time can be
adjusted in increments of 0.1s.
Interval time, expressed in s, defines the time in a surge program during which the current is
kept at 0. See fig 13.122 for details. The interval time can be adjusted in increments of 1s.
Delay time, expressed in s, defines the time delay between the start of the surge program on
channel 1 and channel 2. See fig 13.122 for details. The delay time can be adjusted in
increments of 0.1 s.
With 4 polar interferential current waveforms the current amplitude operates on both channels
simultaneously. In this case a balance facility is available for the classical interferential current
waveform (see paragraph 4.3 for details).
79
The unity of the displayed current amplitude depends on the previously selected current
waveform and can be expressed in mA, µA or V.
A treatment is started by adjusting the current amplitude, unless a surge program has been
selected. To start a surge program, push the Assist button and deactivate the pause symbol with
the central controller and the confirmation button [6].
The ultrasound Amplitude can be displayed in W or . You can change this setting in the
ultrasound parameter menu.
During treatment the displayed ultrasound Amplitude can vary around the set value, caused by
fluctuations in acoustical coupling. A blinking display indicates insufficient acoustical coupling.
The 600-series is equipped with a memory to store protocols. Push the Assist button [7] and
select store in the pop-up with the central controller [5]. Follow the instruction on the screen.
The 600-series provides a number of pre-programmed protocols available via Body Part or
Application. These protocols only serve as a guide and you should use your own expertise in
applying them.
A protocol consists of one or more treatment steps that are sequentially executed. Each
treatment step has its own current waveform, parameter settings and treatment time.
Electrotherapy protocols can constitute either single or dual channel applications. Prior to
loading a single channel protocol, the target channel must first be specified. When a single
channel protocol is executed, a completely different single channel protocol can be executed at
the other channel. It is also possible to link the current channels, which causes the protocol to
be executed on both channels. Dual channel protocols can only be loaded when the current
channels are linked.
When a protocol is executed, the display shows the remaining treatment time of the running
treatment step, while the total treatment time of the protocol is displayed in the channel tab.
When the selected protocol consists of only one treatment step, both times displayed are
identical. Each treatment step is terminated with a short beep. When the end of the protocol has
been reached, a standard “end-of-treatment” beep is given.
► 12:45
15.00 mA 14.30 mA
• The setting will be
stored under Electrotherapy 1+2
Personal setting by
number
• Push the confirmation à Store
button [6] to accept
• To change the name,
select WX with the
central controller [5]
E N 0 0 0 4
► 12:45
15.00 mA 14.30 mA
81
• Remove the cursor Electrotherapy 1+2
with the central
controller [5] to the
desired position à Store
• Push the confirmation
button [6] to modify
the first character D
• Note: Store the
settings before E N 0 0 0 4
starting the F
treatment.
► 12:45
15.00 mA 14.30 mA
82
12 Maintenance and Troubleshooting
CAUTION:
Between patient uses, the sponge pads should be washed in warm water, using a household
cleaner. After washing they must be rinsed with clear water, thoroughly drained and then dried.
Damaged sponge pads should be replaced.
General
The treatment head and the cable must be regularly checked for damage such as hairline tears
which would allow fluid to penetrate.
Note!
• Do not rinse the head under running water!
• Never immerse the head in water or other (cleaning) liquids!
• For proper cleaning of the head’s contact surface, the rubber cuff may be folded back
on one movement (see Figure A).
If necessary, you can push up the head a bit from beneath (see Figure B).
ATTENTION: Never fold the entire cuff ! (See Figure C.)
Note:
In order to guarantee good transmission of the ultrasound energy, you must use original Enraf-
Nonius gelpads.
Do not use regular (liquid) sonogel because this will be sucked up into the vacuum pump!
Warranty claims in which the remnants of regular ultrasound gel are found in the pump, hoses
or connections will be rejected by Enraf-Nonius.
Figure A
Figure B
84
Figure C
Calcium scale can be deposited on the metal surfaces of the electrodes. This has an insulating
effect. In order to maintain optimum conductivity, these surfaces should be regularly cleaned
and polished.
Electrode cables
Check the cables regularly for damage and/or poor contacts. It is recommended to keep a spare
electrode cable in stock.
Water reservoir
If the water reservoir is full a pop-up screen will appear. The unit should than be switched off
and the water reservoir should be emptied by removing the hose [23] outside the unit, opening
the valve and letting the liquid run out. After this the valve should closed and stored back into
the unit. The unit can be turned on again.
The following registered products may be used for disinfecting the water reservoir:
BAKTOLAN to 5%, CHINOSOL to 1%, CHLORAMIN solution, ELMOCID Gamma to 2%
MEFAROL to 1%, MERCKOJOD to 1%, MERFEN, PERHYDROL, PERODIN, SAGROTAN to
2%, ZEPHIROL to 5%.
85
12.2 Troubleshooting
If the problem occurs in CC mode, the current amplitude will ramp down to 0 and will have to be
readjusted when the problem has been removed.
If none of the above scenarios appear to be the problem, stop using the device and contact your
supplier.
On request a service manual can be made available containing: spare part list, descriptions,
calibration instructions and other information which will assist the user’s appropriately qualified
technical personnel to repair those parts of the equipment which are designated by the
manufacturer as repairable.
CAUTION:
• Electrical safety of the device relies on a proper earthed electrical connection via the
power cord. It is therefore necessary to have this connection checked annually.
• To ensure continued compliance with the 21 CFR 1050.10 standard, this unit should be
adjusted and safety tested once each year. Procedures laid down in the service manual
should be followed. This may be carried out by your supplier, or by another agency,
authorized by the manufacturer. It is also recommended that a service history record is
maintained. In some countries this is even obligatory.
• Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
WARNING:
• This unit operates with high voltages. No attempt should be made to disassemble the
unit. Maintenance and repair should be carried out by authorized personnel only. The
manufacturer will not be held responsible for the results of maintenance or repairs by
unauthorized persons.
The 6-series contains materials that can be recycled and/or are noxious to the environment.
Specialized companies can dissemble the unit and sort out these materials. When you dispose
of the unit, find out about local regulations concerning waste management.
86
13 Illustrations
13.1 Biphasic Pulsed Current TENS
13.1.1 Asymmetrical t Phase duration
fp Pulse frequency
13.1.2 Asymmetrical Alternating
t Phase duration
fp Pulse frequency
13.1.3 Burst Asymmetrical
fB Burst frequency
13.1.5 Symmetrical t Phase duration
ti Phase interval
fp Pulse frequency
13.1.6 Burst Symmetrical fB Burst frequency
87
88
13.2 Premodulated / Isoplanar vector / Dipole
vector
fc Carrier frequency
fb Beat frequency
fc Carrier frequency
fB Burst frequency
13.4 Micro Current
f Frequency
fp Pulse frequency
13.6 Diadynamic Current
13.6.1 MF
13.6.2 DF
89
13.6.3 LP
13.6.4 CP
13.6.5 CPid
90
13.7 IG Pulsed Currents
Envelope
91
13.7.4 IG50 Biphasic
Envelope
Envelope
Envelope
92
13.7.7 IG150 Monophasic
Envelope
Envelope
93
13.8 Faradic Pulsed Current
ti Phase interval
tp Phase duration
ti Phase interval
13.8.3 Rectangular Pulsed current
tp Phase duration
ti Phase interval
tp Phase duration
ti Phase interval I
tp Phase duration: 2 ms
ti Phase interval: 5 ms
94
fm Frequency modulation
fp Pulse frequency
fm Frequency modulation
fp Pulse frequency
fm Frequency modulation
tr Ramp up time
th Hold time
ti Interval time
td Delay time
95
13.13 Vacuum pulsed mode
p Vacuum pressure
r Range
th Hold time
13.14 Ultrasound Ultrasound parameters:
t 0.5 – 8 ms
RTPA 20 – 1.25
14 Specifications
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)
5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
96 3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : to be determined
21 CFR 1050.10 : to be determined
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum
Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum
Description of ultrasound field
The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm²
applicator at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance
from the applicator surface. This field distribution applies for the radiation emitted into the
equivalent of an infinite medium of distilled, degassed water at 30 ºC and with line voltage
variations in the range of ± 10% of the rated value. The ultrasonic beam is characterized by the
Effective Radiation Area (ERA) and the Beam Non-uniformity Ratio (BNR).
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value
depends on the ultrasound standard used: - International: IEC 60601-2-5: 2000
- USA: 21 CFR 1050.10
The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the
average ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is
indicative for the absence of high and potentially dangerous energy concentrations.
Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV)
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.1 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual
The maximum current amplitude within the specification is achieved up to a load of 500 Ω (CC).
Surge program
With some current waveforms a surge program is available.
The parameters and their range are as follows:
Ramp-up time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, below 1s in steps of 0.1s, otherwise in steps of 1s
Interval time
Delay time
: 0 - 120 s, in steps of 1 second
: 0.1 - 80 s, below 1s in steps of 0.1s, otherwise in steps of 1s
97
Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC
Isoplanar vector
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 100 mA
Current mode : CC
Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.
Asymmetrical Alternating
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 - 140 mA.
Burst Asymmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.
Burst Symmetrical
Phase Duration : 10 - 1000 µs in steps of 5 µs
Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz
Phase Interval : 0 – 255 µs, in steps of 5 µs
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Amplitude : 0 - 140 mA.
Premodulated
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency : 0 - 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Amplitude : 0 - 100 mA
99
Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burstfrequency : 0 - 100 Hz in steps of 1 Hz
Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
Amplitude : 0 - 100 mA
Micro Current
Frequency : 0 – 1000 Hz, 0 – 10 Hz in steps of 0,1 Hz, 10 -100 Hz in
steps of 1Hz., 100 – 1000 Hz in steps op 10 Hz
Polarity : Positive or Negative
Amplitude : 10 µA - 1 mA
Diadynamic current
Settings : MF, DF, CP, LP en CPid
Surge Program : on MF and DF
Polarity : Positive or Negative
Amplitude 0 - 70 mA
100
Faradic Rectangular Pulsed Current
Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 15000 ms
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA
14.4 EMG
E.M.G. Channels : 2
Sensitivity : 0,5 µV – 10.000 µV
Raw EMG signal : 1.500 Hz
Sample frequency : 160 Hz
Bandwidth : 5 – 1.500 Hz
Filtering : digital
101
14.5 Safety and Performance standards
102
14.6 EMC details
Radiated RF 3 V/ m 3 V/ m d = [3,5/3]√P
IEC 61000-4-3 80 MHz to 2,5 GHz
d = [3,5/3]√P 80 MHz to 800 MHz
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people
Main unit:
Dimensions : 39 x 37 x 12 cm (w x d x h)
Weight : 4,75 Kg
Vacotron reservoir :
Dimensions : 39 x 37 x 6 cm (w x d x h)
Weight : 1,5 Kg
105