DR - Azad.enraf - Sonopuls 490
DR - Azad.enraf - Sonopuls 490
DR - Azad.enraf - Sonopuls 490
Operating Instructions
2
9.1.8 Cleaning the water reservoir and hoses: .................................................................................. 42
9.2 Warning Messages, Error Messages and Troubleshooting ..............................................42
9.2.1 Error code ................................................................................................................................. 42
This manual has been written for the owners and operators of the 4-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.
This device is designed to only be used by or under the supervision of persons using the medical device
in the course of their work and in the framework of a professional healthcare activity, who understand the
benefits and limitations of electrotherapy and ultrasound therapy. I.e.“professional users”.
Specifications put forth in this manual were in effect at the time of publication. However, owing to Enraf-
Nonius her policy of continual improvement, changes to these specifications may be made at any time
without obligation on the part of Enraf-Nonius.
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. Enraf-Nonius cannot be held liable for any
consequence resulting from incorrect information provided by its personnel, or errors incorporated in this
manual and / or other accompanying documentation (including commercial documentation)
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.
2 Product Description
The 4-series is a family of products for physical therapy. The devices share an identical control panel
equipped with a full colour touch panel. The devices are mains powered and can optionally be equipped
with a battery for mains independent operation. The family comprises the products described below.
Endomed 482:
The Endomed 482 is equipped with two completely identical electrotherapy channels. The electrotherapy
channels can be used in combination (linked) or totally independent. A comprehensive set of current
waveforms is available, targeting both pain management and muscle stimulation applications. Protocol
driven operation is available, providing both factory or user defined sequences of treatment steps.
Protocols can run on linked or independent channels. With independent channels two different protocols
can be performed simultaneously.
Sonopuls 490:
4 The Sonopuls 490 is an ultrasound therapy device. The device provides two positions for attachment of
an ultrasound applicator. Depending on the device configuration ordered, the Sonopuls 490 comes with
Sonopuls 492:
The Sonopuls 492 is a combination device, combining the functions of the Endomed 482 and the
Sonopuls 490 in a single device. With the Sonopuls 492 the simultaneous application of ultrasound and
electrotherapy (combination therapy) is also possible. The remaining electrotherapy channel can then be
used independently.
Vacotron 460:
Electrotherapy can be applied through standard or vacuum electrodes. With vacuum electrodes the
Vacotron 460 generates the vacuum through which the vacuum electrodes are attached to the patient.
The device is placed beneath the Endomed 482 or Sonopuls 492, from which its power is derived and
through which it is also operated.
3 Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of when using the
4-series. See also chapter 4.1 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.
• This 4-series 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 stickers 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 the ultrasound applicator with care. Inappropriate handling of the ultrasound applicator
may adversely affect its characteristics.
• Inspect the 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 4-series when connected to any unit other than Enraf-Nonius BV devices.
• This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F), with
a Relative Humidity ranging from 20%-90% non condensing.
• 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 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, contra-indications,
warnings and precautions. Consult other resources for additional information regarding the
application of electrotherapy and ultrasound therapy.
Note (1)
However the application area for the treatment of Dysphagia is distant enough from the sinus
carotis area, when the therapist follows the guidelines as described in the therapybook
"Dysphagia (by H.C.A. Bogaardt SLP, PhD)"
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:
• Reciprocal application, where stimulation alternates between agonists and antagonists. This is
accomplished through asynchronous stimulation over two current channels with an appropriate
delay between the two channels.
• Co-contract application, where two channels operate synchronously to co-contract agonist and
antagonist or different sections of a larger muscle group.
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, of which the following are available in the 4-series:
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
8 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.
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 4.1.4.12.
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 4.1.4.4.1 for a graphical representation.
9
To prevent accommodation to stimulation or to improve patient tolerance, the pulse frequency can be
varied through frequency modulation. Several frequency modulation programs are available. See fig
4.1.4.12 for details.
Parameters:
Phase Duration, expressed in µs, is the elapsed time from the beginning to the end of the initial pulse
phase. See fig 4.1.4.4.1 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the TENS
pulses. See fig 4.1.4.4.1 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 4.1.4.12.
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
4.1.4.4.3 and fig 4.1.4.4.4 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 end of the initial pulse
phase. See fig 4.1.4.4.3 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the TENS
pulses. See fig 4.1.4.4.3 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.
See fig 4.1.4.4.4 for details.
4.1.3.2.3 Symmetrical
TENS current pulses can also be used for muscle stimulation applications. Often the symmetrical
biphasic pulsed current waveform is used. See fig 4.1.4.4.5 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 end of a pulse phase.
The phase duration applies to each pulse phase. See fig 4.1.4.4.5 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the TENS
pulses. See fig 4.1.4.4.5 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
10 final frequency will vary from 80 – 120 Hz.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 8.2.5.6 for details.
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 4.1.4.4.6 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 end of the initial pulse
phase. See fig 4.1.4.4.5 for details.
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the TENS
pulses. See fig 4.1.4.4.5 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.
See fig 4.1.4.4.6 for details.
4.1.3.3 Premodulated
As with Interferential currents, a medium carrier frequency is used to pass the low frequency stimulation
(beat) frequency through the skin. See fig 4.1.4.1 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.
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 .
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 8.2.5.6 for details.
This current type is an intermittent alternating current with a carrier frequency around 2500 Hz. See fig
4.1.4.2 for the current waveform. Russian Stimulation was first used by Kots, a lecturer in sports medicine
11
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 8.2.5.6 for details.
Micro Current is a monophasic rectangular waveform with manually selectable or alternating polarity. See
fig 4.1.4.10 for a graphical representation. Many therapists prefer Micro Current therapy because of the
low current amplitudes used. Alternating polarity can be used to average out the DC component, thereby
reducing the formation of electrolysis by-products.
Parameters:
Alternation mode defines whether the polarity of the wave is automatically alternating or not.
Alternation Period, 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 8.2.5.6 for details. Surge programs are only available in the non alternating mode.
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.
12
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the twin
pulses. See 4.1.4.9 for details.
Frequency Modulation, expressed in %, defines a variable frequency range that is subtracted from the
Pulse frequency i.e. when the Pulse frequency is set to 80 Hz and the Frequency modulation is set to
50%, the final frequency will vary from 40 – 80 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 4.1.4.12.
Alternation Mode defines whether the polarity of the pulses is automatically alternating or not.
Alternation Period, expressed in seconds, defines the polarity reversal time in the alternating mode.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 8.2.5.6 for details. Surge programs are only available in the non alternating mode.
The Diadynamic currents were introduced by Bernard(2) and 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 moistened sponge /
electrode combinations to absorb these by-products during treatment. See paragraph 7.1.5 for
details.
Is a single phase rectified sinusoidal current with a frequency of 50 Hz. See fig 4.1.4.11.1 for details. MF
is a vibrating waveform that easily induces contractions.
Is a dual phase rectified sinusoidal current with a frequency of 100 Hz. See fig 4.1.4.11.2 for details. DF is
usually experienced as a slight vibration. It is a pleasant waveform that is often used as an introduction to
CP or LP.
Is a slow alternation between six seconds of MF current and a six-second DF current. In the DF phase
the intervals between the MF pulses are filled with additional pulses with gradually increasing and
decreasing amplitude. See fig 4.1.4.11.3 for details. LP is smoother than CP.
Is a rapid alternation between one second of MF current and one second of DF current. See fig 4.1.4.11.4
for details. CP has a strong resorbing effect.
13
Is identical to CP, except that the current amplitude during the MF phase is 12.5% lower than during the
DF phase. See fig 4.1.4.11.5 for details. Normally a lower frequency is experienced to be more
aggressive than a higher frequency. CPid prevents this difference in sensation.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 8.2.5.6 for details. Surge programs are only available with MF and DF.
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 4.1.4.8 for details).
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
7.1.5 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 4.1.4.7 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 7.1.5 for details.
Faradic currents are often used for muscle stimulation applications that are based on prior diagnostics.
See fig 4.1.4.5.2 and 4.1.4.5.3 for the current waveforms. The diagnostic objective is to obtain information
on the sensitivity of the neuromuscular apparatus to electrical stimulation. This gives an indication of the
degree of denervation of the muscle tissue. With this technique the relationship between the current
amplitude and phase duration of a rectangular and triangular pulse is plotted in a strength/duration curve.
The strength/duration curve is recorded by observing the current amplitude required at various phase
duration values (ranging from 0.01 to 1000ms) that produce a just perceptible (i.e. just visible or palpable)
contraction of a muscle or muscle group. The values observed can be plotted on graph paper with a
logarithmic scale. In the case of reduced or absent sensitivity to electrical stimulation, the
strength/duration curve gives an indication of the current waveform, phase duration and current amplitude
of the electrical stimulus to be used in any therapy that may be applied.
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 7.1.5 for
details.
Parameters:
14
Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the current
pulses. See fig 4.1.4.5.2 and 4.1.4.5.3 for details.
Surge Program can be used to adjust repeated sequences of contraction and rest periods. See
paragraph 8.2.5.6 for details.
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 specialists have adopted the therapy and it is still applied with
success. A remarkable effect is that patienst are free from pain which can appear from just the first
treatment and which can last for several hours. See fig 4.1.4.5.1 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 7.1.5 for
details.
Parameters:
Phase Duration, expressed in ms or s, is the elapsed time from the beginning to the end of the pulse
phase. The default setting is 2ms. See fig 4.1.4.5.1 for details.
Phase Interval, expressed in ms or s, is the elapsed time between successive pulse phases. The default
setting is 5ms. See fig 4.1.4.5.1 for details.
15
fc Carrier frequency
fb Beat frequency
fc Carrier frequency
fB Burst frequency
fp Pulse frequency
4.1.4.4.2 Asymmetrical Alternating
t Phase duration
fp Pulse frequency
4.1.4.4.3 Burst Asymmetrical
fB Burst frequency
16
4.1.4.4.5 Symmetrical
t Phase duration
ti Phase interval
fp Pulse frequency
tp Phase duration: 2 ms
ti Phase interval: 5 ms
tp Phase duration
fp Pulse frequency
tp Phase duration
fp Pulse frequency
17
fp Pulse frequency
f Frequency
4.1.4.11.1 MF
4.1.4.11.2 DF
18
4.1.4.11.4 CP
4.1.4.11.5 CPid
19
fp Pulse frequency
fm Frequency modulation
6 : 6 or 12 : 12
fp Pulse frequency
fm Frequency modulation
1 : 30
fp Pulse frequency
fm Frequency modulation
tr Ramp up time
th Hold time
ti Interval time
td Delay time
20
• 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.
• Precaution should be taken when using therapeutic ultrasound on patients with hemorrhagic
diatheses.
• Ultrasound treatment presents a potential safety hazard in patients whose pain response has
been decreased because of disease, previous surgery, ionizing radiation therapy, chemotherapy,
general or regional anaesthesia. It may cause burns. Do not use on insensitive areas or in the
presence of poor circulation.
• Large thermal doses may result in regions of thermal aseptic necrosis which may not be apparent
on inspection of the skin.
• See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
• 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 as yet
undetermined effects, in as much as the safety of such treatments has not yet been established.
21
• Cataracts
• Male sterility
• Enhanced drug activity
• Thermal stress
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 by the Duty Cycle.
The combined Contra-indications and Adverse Effects of paragraph 4.1 and 4.2 apply.
5 Package Contents
Device model:
The package contents depend on the device model ordered. The following models are available:
22
1630905 Ultrasound Head Large - NCS S7010-R90B
1630915 Ultrasound Head Small - NCS S7010-R90B
1460266 Moist pads for rubber electrodes 6x8 cm, set of 4 pcs.
3444020 Strap 100x3 cm
3444021 Strap 250x3 cm
2 x 3444129 Rubber electrodes 6x8 cm, 2 mm female, set of 2 pcs.
2 x 3444211 Patient cable 2-core & 2 mm male plugs - black, with coloured clips
6 Installation
6.1 Systems without a Vacotron
• Remove the 4-series device and any additional items ordered from the carton and inspect for
damage that may have occurred during shipment.
• Place the device on a desk or EN-Car. Ensure that there is sufficient air flow below the device (do
not place the device on a table-cover).
• If required, place the unit on the supplied inclination foot to improve display legibility
• Remove the vacuum 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. Ensure that there is sufficient air flow below the
device (do not place the device on a table-cover)..
• Remove the 4-series device and any additional items ordered from the carton and inspect for
damage that may have occurred during shipment.
• Place the main device on top of the vacuum unit.
• Carefully lift the main device at the front and insert flat cable [17] into connector [18].
• Insert the mains cable into socket [1] and connect it to a wall socket.
23
• When you have finished treatments turn the device off by setting the power line switch [1] to Off
(0). The device is now disconnected from the mains supply.
• Remove the mains cable from the power line connector [1].
• Place the 4-Series device upside down and on a soft surface.
• Remove the two screws from the battery cover using the supplied screwdriver.
• Slide and lift the battery cover.
• Align the battery on the bottom of the main unit with the polarity of battery terminals in the correct
position. The polarity is marked at the bottom of the battery compartment.
• Locate the black wire and attach it to the – terminal of the battery.
!CAUTION:
• Do not interchange the black and red wires as this will damage your device.
• The battery contains material that is noxious to the environment. Observe the local
regulations when disposing of the battery. See also chapter 9.5.
• Due to the high current demand of ultrasound applications, we recommend to explicitly
use batteries supplied by Enraf-Nonius B.V. (part number 2501016).
• Locate the red wire and attach it to the + terminal of the battery.
• Slide the battery upside down into the battery compartment taking care that the wires do not get
jammed.
• Place and slide the battery cover back into position.
• Secure the battery cover with the two screws using the supplied screwdriver.
• Place the device back on its feet.
• Reconnect the mains cable to the power line connector [1].
• Leave power line switch [1] in the Off position (0) and turn on the device on using push button [4].
24 •
•
Power LED indicator is lit orange, indicating that the device is operating from the battery.
The charge status of the battery is indicated in the right hand top corner of the display.
With the power line switch [1] On (1), the battery is automatically charged, independent of the state of the
on/off push button [4]. We recommend to use the apparatus from the powerline whenever possible. This
will increase the service life of the battery.
7 Application Information
7.1 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.
• 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.
• 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.
Wrong application of fixation straps, resulting Correct application of fixation straps, resulting
25
in poor electrical conductivity. in good electrical conductivity.
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 than 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 largest 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
electrode 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.
To find the maximum recommended current amplitude in mA for the Interferential, Premodulated and
Russian Stimulation current waveforms, multiply the electrode surface in cm² by two. For all other current
waveforms the stimulator output current can never exceed 50 mA r.m.s. This implies that with an
electrode surface of 25 cm² the current density can never exceed 2 mA r.m.s. / cm². As a rule of thumb
for smaller electrodes, such as the 3.2mm self adhesives, the maximum current setting available on the
stimulator for a given current waveform should proportionally be reduced.
For a precise calculation of the r.m.s. value of a pulsed current waveform the following formula can be used:
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.
26
The contact control function does not work at Amplitudes below 0.2 W/cm².
• 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.
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.
7.3 Vacuum
Vacuum electrodes make good contact with the skin, which means that effective use is made of the whole
electrode area. The massage effect resulting from the pulsed vacuum ensures a good blood flow through
the skin under the electrodes. This reduces the resistance of the skin and increases he effectiveness of
the stimulation current.
27
8 Operating Instructions
! WARNING:
• Do not connect externally powered USB devices or other information technology equipment as
this can adversely affect the safety of the patient.
28
!CAUTION:
Connections [8] [9] [10] [11] [12] [13] are intended for the connection of type BF applied parts
complying with the leakage current requirements of IEC 60601-1.
29
The display is organized as a spreadsheet of 3 sheets, one for each channel. The channels refer to the
patient connector groups accessible at the front of the unit. A sheet can be selected by touching its tab.
The tab shows important information, such as the output amplitude and the remaining treatment time.
This information is continuously visible, also when the sheet is not selected.
A selected sheet gives an overview of the parameters belonging to that channel. A parameter can be
selected by touching it, which causes its colour to be changed into silver and the light ring around the
central controller [7] to be illuminated. The parameter can now be adjusted with the central controller [7].
The parameter can be closed by touching it again or by touching another parameter.
30
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 by touching the button to navigate to the next
screen. You can navigate back to the previous screen by touching the back arrow at the top of the
screen. Anywhere in the navigation, you can jump back to the Home menu, by touching the home button.
8.2.3 Navigation
8.2.3.1 Electrotherapy
Home
The Home menu gives access to all functions of the unit. Select the
desired function or therapy by touching the button
The next screen appears
Use the central controller to scroll through the list and select the
clinical protocol by touching the button.
For therapy information touch the info button on the left side of the
protocol and the therapy info will appear.
31
Use the central controller to scroll through the pages, in most cases
the first page is text followed by one or more illustrations.
Channel Selection
In this screen the user can adjust the intensity or change the
parameter by touching the button and changing the value with the
central controller.
If there is a vacuum unit available the user can set the vacuum
settings direct from the menu.
Intensity setting
32
Channel Selection
Parameter screen
Adjust the parameters by touching the button and change the value
with the central controller [7]
Note: some parameters are grouped and in the next screen the
settings can be changed the same way as above
33
Touch the timer button, the color changes into silver and adjust the
treatment time with the central controller [7]
Start the therapy by adjusting the intensity with the central controller
[7]
Use the central controller to scroll through the list and select the
clinical protocol by touching the button.
For therapy information touch the info button left of the protocol and
the therapy info will appear.
34
Use the central controller [7] to scroll through the pages, in most
cases the first page is text followed by one or more illustrations.
The Home menu gives access to all functions of the unit. Select in
the Home menu combination therapy by touching the button
“Combination Therapy”
35
36
8.2.3.4 Vacuum
If a unit is equipped with a Vacotron it’s possible to select either
rubber electrodes or vacuum cups.
• Touch the – button and adjust the pressure using the central
controller [7]. The vacuum cups are automatically selected when
the pump starts to run.
37
Notes:
• Once saved, favorites can be retrieved from the
Electrotherapy, Ultrasound Therapy and Combination
Therapy menus.
• 4-polar treatments are automatically saved and loaded as a
dual channel treatment.
• Vacuum settings are not saved.
The Home menu gives access to all functions of the unit. Select in
the Home menu System Settings by touching the button “System
Settings”
38
Button Meaning
Page number / number of pages in multi page menu screens or treatment step number /
number of treatment steps in sequential protocols.
Delete Favorite.
Pause treatment. The output current decreases to 0 and the treatment timer suspends
counting down.
Start/Continue treatment. The output current increases to the previous value and the
treatment timer resumes counting down.
Vacuum electrodes
Ultrasound Applicator A
39
Channel paused
Channel running
[i] Remaining treatment time. When a sequential protocol has been loaded, the value indicates the
total remaining treatment time of the sequential protocol.
[j] Output value
[k] Unit of Output value: µA, mA, V, W, W/cm2
To adjust the output current, touch the tab of the selected channel. Its colour will change to orange, after
which the current amplitude can be set with the central controller [7].
The current amplitude can only be adjusted when the clock has been set.
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 4.1.3 for details).
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, touch the Start/Continue button in the navigation bar (8.2.5.6).
Depending on the selected current waveform, the electrotherapy channels can be used in the Constant
Current or Constant Voltage mode. It is advised to use the CV mode with dynamic electrode applications.
In CV mode the output current depends on the electrical contact with the patient and can therefore vary.
You can change the CC/CV setting in the parameter menu.
When DC currents are used, the red connection is the positive connection and the black one the
negative connection.
Manually changing the polarity during a treatment will result in a current decaying to 0, followed by a
current with the opposite polarity, rising to a value equal to 80% of the previous value.
Surge programs allow you to program sequential increases and decreases in current amplitude. See fig
4.1.4.13 for details. Surge programs should not be confused with protocols:
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. In
this case a delay time can be set between the start of the surge on channel 1 and channel 2.
A treatment with a Surge Program is started by first finding the desired current amplitude. During this time
the system pauses. When the current amplitude has been established, the treatment can be started by
touching the Start/Continue button in the navigation bar.
40 Parameters:
Hold time, expressed in s, defines the time in a surge program during which the current is kept at the
adjusted level. See fig 4.1.4.13 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 4.1.4.13 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 4.1.4.13 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 4.1.4.13 for details. The delay time can be adjusted in increments of 0.1 s.
CAUTION:
Between patient uses, the sponge pads should be washed in warm water, using a household cleaning
agent. After washing they must be rinsed with clear water, thoroughly drained and then dried. Damaged
sponge pads should be replaced.
41
solution. Check the applicator and cable regularly for damage.
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.
Clean the vacuum cable with a damp cloth. Use lukewarm water and a non-abrasive household cleaning
agent. Do not use an alcohol solution. Check the cable regularly for damages and/or bad electrical
contact. We advise, keeping a spare vacuum cable in stock.
(1)
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%.
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 solved.
If none of the above scenarios appear to be the problem, stop using the device and contact your supplier.
The battery is insufficiently charged to complete the treatment at the currently set therapy levels. Reduce
the therapy levels or connect the apparatus to the mains supply.
42
The water separation tank of the Vacotron is full. Continue the treatment with the standard electrodes or
empty the tank as follows:
• Set power line switch [1] Off (0).
• Detach the hose from the upper hose nipple [15] and empty the reservoir.
• Reattach the hose to the hose nipple.
• Set power line switch [1] On (1).
There probably is a leak in the vacuum system. This error is usually preceded by a continuously running
pump trying to reach the set vacuum. To protect the system, the pump is automatically stopped after a
certain amount of time. Inspect the vacuum cables and electrodes, set the vacuum back to zero and try
again. If the failure persists, stop using the device and contact your supplier.
The ultrasound applicator has reported an error. Disconnect the device, wait some time and reconnect it.
If the error persists, stop using the device and contact your supplier.
This problem can sometimes occur with the small ultrasound applicator when operating from the battery.
If possible, continue the treatment with reduced therapy levels or connect the apparatus to the mains
supply.
When you experience difficulties with the contact control function of the ultrasound applicator you can try
to resolve the problem as follows:
• Ensure that the surface of the ultrasound applicator is clean and dry.
• Place the ultrasound applicator in the holder.
• Go to System Settings -> Maintenance and select Optimize Applicator A or B.
• Touch the OK-button when the operation is complete.
When you have programmed and stored several Favorites, you might want to make a back-up on an
external storage device. To store your favorites, proceed as follows:
• Attach a USB-stick to the remote control connection [3]. Read and obey the warnings and
cautions mentioned in paragraph 8.1.
• Go to Systems Settings -> Maintenance and select Back-up Favorites.
• If an error occurs during the back-up operation, i.e. USB-stick full, this will be displayed in a pop-
up message.
• Touch the OK-button when the operation is complete.
• Detach the USB-stick
• Attach the USB-stick containing your Favorites to the remote control connection [3]. Read and
obey the warnings and cautions mentioned in paragraph 8.1.
• Go to Systems Settings -> Maintenance and select Restore Favorites.
• If an error occurs during the restore operation, i.e. no favorites found, this will be displayed in a
43
pop-up message.
• Touch the OK-button when the operation is complete.
If your system requires a Firmware Update, contact your supplier to obtain a USB-stick containing the
latest firmware version. Your current firmware version can be viewed under System Settings. To update
your firmware proceed as follows:
• Attach the USB-stick containing the firmware to the remote control connection [3]. Read and obey
the warnings and cautions mentioned in paragraph 8.1.
• Go to Systems Settings -> Maintenance and select Update Firmware.
• If an error occurs during the update operation, i.e. no firmware found, this will be displayed in a
pop-up message.
• Touch the OK-button when the operation is complete.
• Detach the USB-stick
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 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 properly 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 4-series contains materials that can be recycled and/or are noxious to the environment. Specialized
companies can dismantle the unit and sort out these materials. When you dispose of the unit, find out
about local regulations concerning waste management.
44
Continuous ultrasound
Explanation of symbols:
dc Duty cycle: 5 – 80 %
RTPA 20 – 1.25
Amplitude Duty cycle Pulse RTPA Amplitude Duty cycle Pulse RTPA
modulation duration modulation duration
16Hz 5% 3.1ms 20 48Hz 50% 10.4ms 2
16Hz 10% 6.3ms 10 48Hz 80% 16.7ms 1.25
16Hz 20% 12.5ms 5 48Hz 100%* 20.8ms 1
16Hz 33% 20.6ms 3 100Hz 5% 0.5ms 20
16Hz 50% 31.3ms 2 100Hz 10% 1ms 10
16Hz 80% 50ms 1.25 100Hz 20% 2ms 5
16Hz 100%* 62.5ms 1 100Hz 33% 3.3ms 3.33
48Hz 5% 1ms 20 100Hz 50% 5ms 2
48Hz 10% 2.1ms 10 100Hz 80% 8ms 1.25
48Hz 20% 4.2ms 5 100Hz 100%* 10ms 1
48Hz 33% 6.9ms 3.33
* = continuous mode
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 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2
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
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value can be set
under System Settings (8.2.3.7) and 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), except for
High Voltage (CV) and Microcurrent (CC).
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.2 mA
46 Treatment timer
Polarity reversion direct currents
: 0 - 60 minutes
: manual
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, in steps of 1s
Hold time : 0 - 60 s, in steps of 1 second
Ramp-down time : 0 - 9 s, in steps of 1s
Interval time : 0 - 120 s, in steps of 1 second
Delay time : 0.1 - 80 s, below 10s in steps of 0.1s, otherwise in steps of 1s
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
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
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
Surge Program : Yes
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
Surge Program : Yes
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
Symmetrical
Phase Duration : 10 - 400 µs in steps of 5 µs
Pulse Frequency : 1 - 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 - 140 mA
Burst Symmetrical
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
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 - 140 mA
Russian Stimulation
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Burst frequency : 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
Polarity : Positive or Negative
Surge Program : Yes
Amplitude : 10 µA - 1 mA in steps of 10 µA
48 Diadynamic current
Settings : MF, DF, CP, LP en CPid
Main unit:
Dimensions stand alone : 24 x 32 x 12 cm (w x d x h)
Dimensions on inclination foot : 24 x 30.5 x 18.2 cm (w x d x h)
Dimensions on Vacotron : 24 x 30.5 x 21.6 cm (w x d x h)
Weight : 2 Kg
Weight including optional battery : 3 Kg
Vacotron:
Dimensions : 24 x 28.6 x 9.3 cm (w x d x h)
Weight : 2 Kg
49
21 CFR 898 : This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.
Medical electrical devices such as the 4-series are subject to special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and commissioned in accordance with the
EMC advice given in the instructions for use and accompanying documents.
Portable and mobile RF communication systems (e.g. mobile phones) may interfere with medical
electrical 4-series.
The 4-series should only be operated with the original mains cable specified in the list of contents
delivered.
Operating the device with any other mains cable can lead to increased emissions or reduced interference
immunity of the device.
RF emissions according to CISPR 11 ClassB The 4-series device is suitable for use
in all installations including those in a
Harmonic emissions according to Class B residential environment and those
IEC 61000-3-2 which are directly connected to the
public mains network which also
Voltage fluctuation emissions and Conforms supplies buildings which are used for
50 flicker according to IEC 61000-3-3 residential purposes.
The 4-series device is intended for use in the electromagnetic environment specified below. The
customer or the user of the 4-series device should assure that it is used in such an environment.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient / burst to supply lines supply lines that of a typical commercial or
IEC 61000-4-4 hospital environment.
± 1 kV for input / not applicable
output lines
70% UT 70% UT
(30% dip in UT for (30% dip in UT for 25
25 cycles) cycles)
<5% UT <5% UT
(>95% dip in UT for (>95% dip in UT for 5
5 seconds) seconds)
51
The 4-series device is intended for operation in the electromagnetic environment specified below. The
customer or user of the 4-series should ensure that it is used in such an environment.
Conducted RF 3 Veffective value 3 Veffective value Portable and mobile radio should not
disturbance variables 150 kHz to 80 150 kHz to 80 MHz be used any closer to the 4-series
according to IEC MHz devices, including cables, than the
61000-4-6 recommended separation distance
calculated from the equation
Radiated RF 3 V/m 3 V/m applicable to the transmission
disturbance variables 80 MHz to 2.5 80 MHz to 2.5 GHz frequency.
according to IEC GHz
61000-4-3 Recommended separation
distance:
d= 1.2 √P
NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
NOTE 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Theoretically, it is not possible to exactly predict the field strengths of fixed transmitters such as
base stations for radio telephones and land mobile radios, amateur radio stations, AM and FM radio and
TV broadcasting. To determine the electromagnetic environment in relation to the fixed transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location where
the 4-series device is to be used exceeds the above compliance levels, the 4-series device should be
monitored in order to ensure that it is functioning as intended. If unusual features are noticed, additional
measures may be necessary such as re-orienting or relocating the 4-series device.
b
Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V/m.
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d= 1.2 √P d= 0.35 √P d= 0.7 √P
100 12 3.5 7
For transmitters rated at a maximum output which is not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the respective column, whereby P is the maximum
rated output of the transmitter in Watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
NOTE 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
11 Ordering information
Model numbers:
Optional accessories:
Ultrasound contact-gel
3442929 Contact-gel, bottle 250 ml, box of 12
3442930 Contact-gel, bottle 850 ml, box of 12
3442931 Contact-gel, canister of 5 l
3442932 Dispenser-set for 5 l canister
Rubber electrodes
3444128 Rubber electrodes 4x6 cm, 2 mm female, set of 2.
3444129 Rubber electrodes 6x8 cm, 2 mm female, set of 2
3444130 Rubber electrodes 8x12 cm, 2 mm female, set of 2
Fixation straps
3444020 Strap 100x3 cm
3444021 Strap 250x3 cm
54 3444022
3444023
Strap 100x5 cm
Strap 250x5 cm
Adapters
2523524 Adapter plug, 2 mm female, 4 mm male, red
2523523 Adapter plug, 2 mm female, 4 mm male, black
Patient cable
3444211 Patient cable 2-core & 2 mm male plug - black, with coloured clips
Bag
3444675 Carrierbag 4-series
Battery
2501016 Battery 12.0V 1.8AH
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