Sonopuls 692 6-Series User Manual

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6-series

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

Part number: 1600.751_46


December 2010
6-series
User Manual
3
4
Contents
1 PRODUCT DESCRIPTION.................................................................................................. 10

1.1 Endomed electrotherapy module .................................................................................. 10

1.2 Sonopuls ultrasound module ........................................................................................ 10


1.2.1 StatUS module.........................................................................................................................................10

1.3 Vacotron vacuum module.............................................................................................. 10

1.4 EMG module.................................................................................................................... 11

2 FOREWORD........................................................................................................................ 12

2.1 This manual..................................................................................................................... 12

2.2 Product liability............................................................................................................... 12

3 PRECAUTIONARY INSTRUCTIONS.................................................................................. 13

4 INTENDED USE: ELECTROTHERAPY.............................................................................. 14

4.1 Pain Management ........................................................................................................... 14


4.1.1 Indications/Contraindications ...................................................................................................................14
4.1.2 Current Waveforms..................................................................................................................................14

4.2 Muscle Stimulation ......................................................................................................... 15


4.2.1 Indications/Contraindications and Adverse Effects for Muscle Stimulation ..............................................15
4.2.2 Current Waveforms..................................................................................................................................16

4.3 Description: Current Waveforms .................................................................................. 16


4.3.1 4 Pole Interferential Currents ...................................................................................................................16
4.3.1.a Classical Interferential..........................................................................................................................16
4.3.1.b Isoplanar Vector...................................................................................................................................17
4.3.1.c Dipole Vector Manual...........................................................................................................................17
4.3.1.d Dipole Vector Automatic.......................................................................................................................17
4.3.2 Biphasic Pulsed Currents (TENS)............................................................................................................18
4.3.2.a Asymmetrical and Alternating Asymmetrical ........................................................................................18
4.3.2.b Burst Asymmetrical and Burst Alternating Asymmetrical .....................................................................19
4.3.2.c Symmetrical .........................................................................................................................................19
4.3.2.d Burst Symmetrical................................................................................................................................20
4.3.3 Premodulated...........................................................................................................................................20
4.3.4 Russian Stimulation .................................................................................................................................21
4.3.5 Micro Current ...........................................................................................................................................21
4.3.6 High Voltage ............................................................................................................................................22
4.3.7 Diadynamic Currents ...............................................................................................................................22
4.3.7.a MF (Monophasé Fixe) ..........................................................................................................................23
4.3.7.b DF (Diphasé Fixe) ................................................................................................................................23
4.3.7.c LP (Longues Périodes) ........................................................................................................................23
4.3.7.d CP (Courtes Périodes) .........................................................................................................................23
4.3.7.e CPid .....................................................................................................................................................23
4.3.8 IG Pulsed Currents ..................................................................................................................................23
4.3.9 Galvanic Current ......................................................................................................................................23
4.3.9.a Direct Galvanic Current........................................................................................................................23
4.3.9.b MF Interrupted Galvanic Current..........................................................................................................24
4.3.10 Faradic Rectangular or Triangular pulsed current....................................................................................24
4.3.11 Träbert, 2 – 5 Current ..............................................................................................................................25

4.4 The Strength-Duration Curve (SD Curve) ..................................................................... 25

5 INTENDED USE ULTRASOUND THERAPY AND STATUS.............................................. 26

5.1
5.1.1
Ultrasound....................................................................................................................... 26
Indications/Contraindications and Adverse Effects for Ultrasound...........................................................26
5
5.1.2 Parameters ..............................................................................................................................................27

5.2 Combination Therapy ..................................................................................................... 27

5.3 StatUS Therapy ............................................................................................................... 27

6 INTENDED USE VACUUM.................................................................................................. 29

7 INTENDED USE MYOFEEDBACK ..................................................................................... 29

7.1 Parameters ...................................................................................................................... 29

7.2 Indications/Contraindications and Adverse Effects for Myofeedback ...................... 30

8 PACKAGE CONTENTS ...................................................................................................... 31

8.1 Standard Accessories electrotherapy 682 – 692 - 632 ................................................ 31

8.2 Standard Accessories electrotherapy 684 ................................................................... 31

8.3 Standard Accessories ultrasound 690 - 692 ................................................................ 31

8.4 Standard Accessories Vacuum 682V – 692V – 632V ................................................... 31

8.5 Standard Accessories Vacuum 684V............................................................................ 32

8.6 Standard Accessories StatUS ....................................................................................... 32

8.7 Standard Accessories EMG 632 .................................................................................... 32

8.8 Optional Accessories ..................................................................................................... 32

9 INSTALLATION................................................................................................................... 33

9.1 Units without a Vacotron module.................................................................................. 33

9.2 Units with a Vacotron module ....................................................................................... 33

9.3 Connection to mains supply.......................................................................................... 33

10 APPLICATION NOTES .................................................................................................... 34

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

10.2 Ultrasound ....................................................................................................................... 37


10.2.1 Contact Control ........................................................................................................................................37
10.2.2 The contact medium.................................................................................................................................37
10.2.3 Before treatment ......................................................................................................................................37
10.2.4 During treatment ......................................................................................................................................37
10.2.5 After treatment .........................................................................................................................................39

10.3 StatUS .............................................................................................................................. 39


10.3.1 Connecting the StatUS-applicator ............................................................................................................39
10.3.2 Applying the fixation .................................................................................................................................40

6 10.3.3 Applying the gel pad (gel cushion) ...........................................................................................................40


10.4 EMG.................................................................................................................................. 41
10.4.1 Connections .............................................................................................................................................41

11 OPERATING INSTRUCTIONS ........................................................................................ 42

11.1 Operator Controls........................................................................................................... 42

11.2 Basic Operation .............................................................................................................. 43


11.2.1 Turn on the apparatus..............................................................................................................................43
11.2.2 Navigation and display organization ........................................................................................................44
11.2.3 Home menu .............................................................................................................................................44
11.2.4 Therapy Wizard........................................................................................................................................45
11.2.5 Electrotherapy..........................................................................................................................................46
11.2.5.a Diagnostics .........................................................................................................................................48
11.2.6 Ultrasound therapy...................................................................................................................................52
11.2.7 Combination therapy................................................................................................................................53
11.2.8 StatUS Therapy .......................................................................................................................................54
11.2.9 Vacuum adjustment via Assist button ......................................................................................................56
11.2.9.a Vacuum pulsed mode.........................................................................................................................57
11.2.9.b Vacuum electrode selection ...............................................................................................................57
11.2.9.c Default Setting Vacuum Module .........................................................................................................58
11.2.10 Feedback Therapy ................................................................................................................................58
11.2.10.a Connecting to the MyoComBox ..........................................................................................................60
11.2.10.b Exporting Reports and Measuring Data..............................................................................................61
11.2.10.c Sensitivity setting................................................................................................................................61
11.2.10.d Threshold Setting ...............................................................................................................................62
11.2.10.e Exercise / Rest ...................................................................................................................................64
11.2.10.f Template ............................................................................................................................................65
11.2.10.g Shift ....................................................................................................................................................66
11.2.10.h Myofeedback + Stimulation ................................................................................................................66
11.2.10.i Alternating ..........................................................................................................................................67
11.2.10.j Stimulation above Threshold ..............................................................................................................69
11.2.10.k Stimulation below Threshold ..............................................................................................................71
11.2.10.l Pressure .............................................................................................................................................73
11.2.10.m EMG feedback with 2 channels ..........................................................................................................75
11.2.10.n Analyze...............................................................................................................................................75
11.2.10.o Report.................................................................................................................................................77
11.2.11 System Settings ....................................................................................................................................78
11.2.11.a Change Language ..............................................................................................................................78
11.2.11.b Backup -and restore personal data.....................................................................................................78
11.2.12 Special parameter settings ....................................................................................................................78
11.2.12.a Surge programs..................................................................................................................................79
11.2.12.b Current amplitude ...............................................................................................................................79
11.2.12.c CC/CV mode ......................................................................................................................................80
11.2.12.d Current polarity ...................................................................................................................................80
11.2.13 Ultrasound power/Amplitude .................................................................................................................80

11.3 Memory functions........................................................................................................... 80


11.3.1 Protocols via Therapy Wizard ..................................................................................................................80
11.3.1.a Loading a protocol ..............................................................................................................................80
11.3.1.b Storing a protocol ...............................................................................................................................81

12 MAINTENANCE AND TROUBLESHOOTING ................................................................. 83

12.1 User Maintenance ........................................................................................................... 83


12.1.1 Cleaning of apparatus ..............................................................................................................................83
12.1.2 Cleaning display panel .............................................................................................................................83
12.1.3 Electrodes and accessories .....................................................................................................................83
12.1.4 Patient cable ............................................................................................................................................83
12.1.5 Ultrasound applicator ...............................................................................................................................83
12.1.6 Cleaning of the StatUS Applicator (Stationary Ultrasound Head) ............................................................83
12.1.7 Water reservoir of vacuum unit ................................................................................................................85

12.2 Troubleshooting ............................................................................................................. 86


12.2.1 Error code ................................................................................................................................................86
12.2.2 Insufficient or no output current................................................................................................................86

12.3 Technical Maintenance .................................................................................................. 86 7


12.4 End of life......................................................................................................................... 86

13 ILLUSTRATIONS ............................................................................................................. 87

13.1 Biphasic Pulsed Current TENS...................................................................................... 87


13.1.1 Asymmetrical ...........................................................................................................................................87
13.1.2 Asymmetrical Alternating .........................................................................................................................87
13.1.3 Burst Asymmetrical ..................................................................................................................................87
13.1.4 Burst Asymmetrical Alternating ................................................................................................................87
13.1.5 Symmetrical .............................................................................................................................................87
13.1.6 Burst Symmetrical ....................................................................................................................................87

13.2 Premodulated / Isoplanar vector / Dipole vector ......................................................... 89

13.3 Russian Stimulation ....................................................................................................... 89

13.4 Micro Current .................................................................................................................. 89

13.5 High Voltage .................................................................................................................... 89

13.6 Diadynamic Current........................................................................................................ 89


13.6.1 MF............................................................................................................................................................89
13.6.2 DF ............................................................................................................................................................89
13.6.3 LP.............................................................................................................................................................90
13.6.4 CP ............................................................................................................................................................90
13.6.5 CPid .........................................................................................................................................................90

13.7 IG Pulsed Currents ......................................................................................................... 91


13.7.1 IG30 Monophasic .....................................................................................................................................91
13.7.2 IG30 Biphasic...........................................................................................................................................91
13.7.3 IG50 Monophasic .....................................................................................................................................91
13.7.4 IG50 Biphasic...........................................................................................................................................92
13.7.5 IG100 Monophasic ...................................................................................................................................92
13.7.6 IG100 Biphasic.........................................................................................................................................92
13.7.7 IG150 Monophasic ...................................................................................................................................93
13.7.8 IG150 Biphasic.........................................................................................................................................93

13.8 Faradic Pulsed Current .................................................................................................. 94


13.8.1 Triangular Pulsed Current ........................................................................................................................94
13.8.2 Triangular alternating current ...................................................................................................................94
13.8.3 Rectangular Pulsed current......................................................................................................................94
13.8.4 Rectangular alternating current ................................................................................................................94

13.9 Träbert, 2 – 5 Current...................................................................................................... 94

13.10 Galvanic Current ............................................................................................................. 94


13.10.1 Direct Current ........................................................................................................................................94
13.10.2 MF (medium frequency) Interrupted Current .........................................................................................94

13.11 Modulation program ....................................................................................................... 95


13.11.1 Modulation program 1/1.........................................................................................................................95
13.11.2 Modulation program 6/6 or 12/12 ..........................................................................................................95
13.11.3 Modulation program 1/30.......................................................................................................................95

13.12 Surge program parameters............................................................................................ 95

13.13 Vacuum pulsed mode..................................................................................................... 96

13.14 Ultrasound ....................................................................................................................... 96

14 SPECIFICATIONS............................................................................................................ 96

14.1 Ultrasound parameters................................................................................................... 96


8 14.2 Stimulator output parameters........................................................................................ 97
14.3 Vacuum unit (Vacotron) ............................................................................................... 101

14.4 EMG................................................................................................................................ 101

14.5 Safety and Performance standards ............................................................................ 102

14.6 EMC details ................................................................................................................... 103

14.7 Technical Data .............................................................................................................. 105

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.

1.1 Endomed electrotherapy module


The 6-series is equipped with two completely identical electrotherapy channels.
A comprehensive set of current waveforms is provided for both pain management and muscle
stimulation applications. One electro-module with 2 channel electrotherapy is mounted in the
Endomed 682, two electro-modules are mounted in the Endomed 684. In de Endomed 684 it’s
possible to work completely independent with 2+2 channels electrotherapy or 4 completely
independent channels 1, 2, 3 and 4.

1.2 Sonopuls ultrasound module


The ultrasound module has one multi-frequency ultrasound channel. The multi-frequency
ultrasound applicators for the 6-series provide both 1 and 3 MHz operation. The applicators can
be used with both, large and small treatment surfaces and are suitable for subaqual treatments.
Contact control suspends the application of ultrasonic energy when acoustical contact with the
treatment area becomes insufficient.
The user can connect two ultrasound treatment heads. These can be activated from the
ultrasound menu.
The simultaneous application of ultrasound and electrotherapy (combination therapy) is also
possible. The remaining electrotherapy channel can then be used independently.

1.2.1 StatUS module


StatUS stands for Stationary Ultra Sound: the application of ultrasound without moving the
treatment head (= stationary). In the normal course of events, ultrasound energy is administered
by moving (‘making circles’) the treatment head. This moving of the treatment head (also called
the dynamic or semi-stationary method) is essential because a few unfavourable phenomena
occur both within an ultra-sound bundle as well as in the tissue, which may lead to tissue,
damage (so-called ‘hot spots’). 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’.
These modulation forms are:
1. Duty Cycle Modulation
2. Amplitude Modulation

1.3 Vacotron vacuum module

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.

1.4 EMG module

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.

Myofeedback (or EMG-Feedback) is a method, whereby the electrical activity of a muscle is


registered and passed on as quantitative information (feedback) to:
• the patient (to influence his/her motoric activity)
• the MD/therapist (to determine and evaluation of the movement process of the patient
during voluntary movements

11
2 Foreword

2.1 This manual

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.

2.2 Product liability

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 Pain Management

Pain Management is the use of electrical stimulation for pain relief.

4.1.1 Indications/Contraindications

Indications:

• Symptomatic relief of chronic, intractable pain. Management of pain associated with


post-traumatic or postoperative conditions.

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.

4.1.2 Current Waveforms

14 For pain management the 6-series offers the current waveforms described in paragraph 4.3 -
4.3.9.b.
4.2 Muscle Stimulation

Muscle Stimulation is the use of electrical stimulation to treat muscle dysfunction.

4.2.1 Indications/Contraindications and Adverse Effects for Muscle Stimulation

Indications:

• Relaxation of muscle spasms.


• Prevention or retardation of disuse atrophy.
• Increasing local blood circulation.
• Muscle re-education.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• Maintaining or increasing range of motion.

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:

• 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:

• Adequate precautions should be taken when treating individuals with suspected or


diagnosed heart problems, or epilepsy.
• Caution should be used when there is a tendency to hemorrhage following acute trauma
or fracture.
• Caution should be used following recent surgical procedures when muscle contraction
may disrupt the healing process.
• Caution should be used over the menstruating uterus.
• Caution should be used over areas of the skin which lack normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to electrical
stimulation or electrical conductive medium. The irritation can usually be reduced by
using an alternative conductive medium, or alternate electrode placement.
• 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. 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:

• 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.

See paragraph 11.2.11.a for the available parameters.

4.3 Description: Current Waveforms

4.3.1 4 Pole Interferential Currents

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:

4.3.1.a Classical Interferential


With this therapy method four electrodes are used and two non modulated currents are
generated. The frequency of one channel is fixed at the carrier frequency, while the other
channel has a variable frequency, based on the Beat frequency and Frequency
Modulation settings. Interference occurs where the two currents intersect in the tissue.
The modulation depth (which determines the current amplitude of the stimulation)
depends on the direction of the currents, and can vary from 0 to 100%. 100% modulation
depth only occurs at the diagonals (and hence at the intersection) of the two currents.
This is of course a theoretical situation, based on the assumption that the tissue is
homogeneous. In reality, the tissue is heterogeneous, so that the current balance
between the two channels has to be used to get the 100% modulation depth (Fig. 1).
The current balance can also be used to compensate for differences in sensation
occurring under the electrode pairs.

Modulation depth is only 100% at


the diagonals.

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.

Modulation depth is 100% over the entire treatment area.

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.

4.3.1.c Dipole Vector Manual

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%.

Stimulation with 100% modulation depth only occurs into


the direction of the vector.

The advantage of this method is that the direction of the stimulation can be adjusted
electronically after positioning the electrodes.

4.3.1.d Dipole Vector Automatic

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.

4.3.2 Biphasic Pulsed Currents (TENS)

4.3.2.a Asymmetrical and Alternating Asymmetrical

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.

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 13.11 – 13.11.3 for details.

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.

4.3.4 Russian Stimulation


This current type is an intermittent alternating current with a carrier frequency around 2500 Hz.
See fig 13.3 for the current waveform. Russian Stimulation was first used by Kots, a lecturer in
sports medicine at the Moscow State Acadamy. Kots used it for muscle strengthening in
prosthesiology and in the training of Russian cosmonauts. With this technique the electro
stimulation is applied both to individual muscles and to groups (either directly or via the nerve).
In direct stimulation, a frequency of 2500 Hz was found to produce the greatest contraction,
while the optimum frequency in indirect stimulation was 1000 Hz.

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.

4.3.5 Micro Current


Micro Current is a monophasic rectangular waveform with manually selectable or alternating
polarity. See fig 13.4 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:

Frequency, expressed in Hz, is the number of cycles delivered per second.

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.

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 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.

4.3.7 Diadynamic Currents

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.a MF (Monophasé Fixe)


Is a single phase rectified sinusoidal current with a frequency of 50 Hz. See fig 12.6.1 for
details. MF is a vibrating waveform that easily induces contractions.

4.3.7.b DF (Diphasé Fixe)


Is a dual phase rectified sinusoidal current with a frequency of 100 Hz. See fig 13.6.2 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.

4.3.7.c LP (Longues Périodes)


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 13.6.3 for details. LP is smoother than CP.

4.3.7.d CP (Courtes Périodes)


Is a rapid alternation between one second of MF current and one second of DF current. See fig
13.6.4 for details. CP has a strong resorbing effect.

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.

4.3.8 IG Pulsed Currents


IG currents are triangular pulsed currents. Monophasic and biphasic versions are available.
The monophasic IG30 current consists of a single pulse with a rising slope of 30ms followed by
falling slope of 10ms. See fig 12.7 for details. The biphasic version (fig 13.7.2.1) has two such
phases with opposite polarity. The other types refer to fixed pulses of 300 + 100µs with
envelopes of 50ms for the IG50 current, 100ms for the IG100 current and 150ms for the IG150
current. See fig 13.7.3 thru 13.7.8 for details. The IG currents can be used with pain
management and blood circulation applications.

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.

4.3.9 Galvanic Current

4.3.9.a Direct Galvanic Current

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.

4.3.9.b MF Interrupted Galvanic Current

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.

4.3.10 Faradic Rectangular or Triangular pulsed current


Faradic currents are often used for muscle stimulation applications that are based on prior
diagnostics. See fig 12.8.1 and 12.8.2 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 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.

4.4 The Strength-Duration Curve (SD Curve)

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.

5.1.1 Indications/Contraindications and Adverse Effects for Ultrasound

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.

Precautions and Warnings:


• 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, or general or regional anesthesia. 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.

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.

5.2 Combination Therapy


Combination therapy is the combined application of ultrasound and electrical stimulation. With
combination therapy the metal surface of the ultrasound applicator becomes the negative
electrical stimulation electrode, while the lead wire with the red connector remains the positive
electrical stimulation electrode. Combination therapy is available with all current waveforms, but
limited to channel 2.

Combination therapy is typically used for the reduction of muscle spasm.

The combined Contraindications and Adverse Effects of paragraph 4 and 5 apply.

5.3 StatUS Therapy


StatUS stands for Stationary Ultra Sound: the application of ultrasound without moving the
treatment head (= stationary). In the normal course of events, ultrasound energy is administered
by moving (‘making circles’) the treatment head. This moving of the treatment head (also called
the dynamic or semi-stationary method) is essential because a few unfavourable phenomena
occur both within an ultra-sound bundle as well as in the tissue, which may lead to tissue,
damage (so-called ‘hot spots’). 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’.

These modulation forms are:


1. Duty Cycle Modulation
2. Amplitude Modulation

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 Intended use Myofeedback


Myofeedback is a form of feedback, in which the patient receives electronically recorded
information about his own physiological processes. The electromyographic recording used in
the diagnostics and treatment of the moving mechanism is an indispensable supplement to the
study of movement. When we place electrodes on the skin to obtain information from an EMG
signal about the underlying musculature, we must be acquainted with the development of the
EMG signal and the construction and function of the motor mechanism. Thus, properties and
mutations in the musculature, the joints system, the sensory and the neural system can be
found in the motor system and also in the EMG recording.
Surface EMG provides us with detailed information about the organ-specific properties of a
muscle, such as:
• the activation of the muscle;
• the muscle’s capacity for relaxation;
• coordination between muscles;
• the tiredness of a muscle;
• the capacity of a muscle to lengthen.
This makes Myofeedback especially suitable as a measuring instrument for charting our
locomotive operations (Figure 1).

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.

Precautions and Warnings:


Myofeedback is dangerous for diabetics and others with endocrine disorders, as it can change
the need for insulin and other medications. Please check with the doctor to see whether this is
an appropriate treatment for you.

30
8 Package Contents

6-series unit range:

1600905 Endomed 682


1600915 Endomed 682V
1600925 Endomed 684
1600935 Endomed 684V
1600945 Sonopuls 692
1600955 Sonopuls 692V
1600948 Sonopuls 692 S
1600957 Sonopuls 692V S
1600961 Sonopuls 690 S
1600965 Myomed 632
1600966 Myomed 632 X
1600968 Myomed 632 UX
1600967 Myomed 632 U
1600970 Myomed 632V
1600971 Myomed 632V X
1600972 Myomed 632V U
1600973 Myomed 632V UX

8.1 Standard Accessories electrotherapy 682 – 692 - 632

3444208 Electrode cable 2mm black


3444209 Electrode cable 2mm purple
3444129 Flexible rubber electrode 6 x 8 cm, 2 sets of 2 pc
1460266 Sponges 6 x 8 cm, 1 set of 4 pc
3444020 Fixation strap 100 x 3 cm, 1 pc
3444021 Fixation strap 250 x 3 cm, 1 pc
1600751 User manual 600-series
3444290 Power cord

8.2 Standard Accessories electrotherapy 684

3444208 Electrode cable 2mm black


3444209 Electrode cable 2mm purple
3444210 Electrode cable 2mm grey
3444216 Electrode cable 2mm light grey
3444129 Flexible rubber electrode 6 x 8 cm, 4 sets of 2 pc
1460266 Sponges 6 x 8 cm, 2 sets of 4 pc
3444020 Fixation strap 100 x 3 cm, 2 pc
3444021 Fixation strap 250 x 3 cm, 2 pc
1600751 User manual 600-series
3444290 Power cord

8.3 Standard Accessories ultrasound 690 - 692

1601901 Ultrasound applicator, 1-3 MHz, ERA 5 cm²


Ultrasound gel, bottle of 250 ml
1600810 Ultrasound treatment head holder
xxxxxxx Ultrasound Contact-gel, 1 bottle

8.4 Standard Accessories Vacuum 682V – 692V – 632V

3444507 Electrode cable red, 2 pc


3444508 Electrode cable black, 2 pc 31
3444078 Dummy
3444503 Vacuum electrode Ø 60mm, 2 set of 2 pc.
3444505 Sponges Ø 65 mm, set of 4 pc.

8.5 Standard Accessories Vacuum 684V

3444507 Electrode cable red, 4 pc


3444508 Electrode cable black, 4 pc
3444078 Dummy
3444503 Vacuum electrode Ø 60mm, 4 set of 2 pc.
3444505 Sponges Ø 55 mm, 2 sets of 4 pc.

8.6 Standard Accessories StatUS

1601921 Ultrasound treatment head 5 cm² , 1 & 3 MHz StatUS


xxxxxx x Gelpad for StatUS set of 6 pc
3442942 Fixation ring for gelpad StatUS, 3 pc

8.7 Standard Accessories EMG 632

xxxxxxx Set Adhesive Electrodes for stimulation & EMG, 0,1pc


3444673 EMG cable 6-serie, 2pc
3444674 EMG reference cable 6-serie, 1pc

8.8 Optional Accessories

1601911 Ultrasound applicator, 1-3 MHz, ERA 0.8 cm²


1600811 Ultrasound treatment head holder for 2 heads
3444128 Flexible rubber electrode 4 x 6 cm, set 2 pc
3444130 Flexible rubber electrode 8 x 12 cm, set 2 pc
1460273 Sponges, 4 x 6 cm, set 4 pc
1460275 Sponges, 8 x 12 cm, set 4 pc
3444056 Self adhesive electrodes, size 32mm Ø, 1 pack = 10 sheets of 4 pc
3444135 Self adhesive electrodes, size 50mm Ø, 1 pack = 10 sheets of 4 pc
3444143 Self adhesive electrodes, size 70mm Ø, 1 pack = 10 sheets of 4 pc
3444057 Self adhesive electrodes, size 50x50mm, 1 pack = 10 sheets of 4 pc
3444058 Self adhesive electrodes, size 50x90mm, 1 pack = 10 sheets of 4 pc
3444146 Self adhesive electrodes with double lead, size 50x100mm, 1 pack = 10 sheets of 2
1497801 Remote control 2 channels
3442940 Gelpad StatUS™ 8 x 6 pcs
3442941 Gelpad StatUS™ 40 x 6 pcs
3444118 Vaginal EMG probe
3444117 Anal EMG probe
3444042 Vaginal pressure probe
3444048 Connection hose with air-inlet for vaginal probe 3444042
3444043 Anal pressure probe
3444045 Connection hose for pressure probe 3444043
3444044 Connecting hose for vaginal pressure sensor 3444042
3442929 Contact-gel, bottle 250 ml, box of 12
1600820 EN-Point
3444222 Pregelled disposable electrodes for EMG and stim.
3444302 Pregelled disposable electrodes, 25 pcs
3444380 Silicon electrode 5x5 cm TENS
3444505 Sponges Ø 95 mm, set of 4 (for vacuum electrodes Ø 90 mm)
3444503 Vacuum electrodes Ø 90 mm, set of 2x2
3444667 Snap-connector, 2 mm female, 3 pcs
1600830 Myocombox
32
9 Installation

9.1 Units without a Vacotron module

• 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.

9.2 Units with a Vacotron module

• 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].

9.3 Connection to mains supply

• 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.

10.1.1 Before treatment

• Check the patient for contraindications and warnings as described in paragraph 4


• Test the heat sensibility of the treatment area.
• Rinse the treatment area. Shaving hairy skin is recommended.

10.1.2 Flexible rubber electrodes

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.

10.1.4 Self-adhesive electrodes

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.

CAUTION: Do not use electrodes on open wounds.

10.1.5 Electrolytic effects

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.

10.1.6 Current density

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:
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

10.2.1 Contact Control

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.

10.2.2 The contact medium

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.

10.2.3 Before treatment

• 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.

10.2.4 During treatment

• 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.

10.2.5 After treatment


• Clean the skin of the patient and the ultrasound applicator with a towel or tissue. Clean the
applicator with a 70% alcohol solution.
• Check for the effects that can be expected (for example pain, circulation and mobility).
• Ask the patient to inform the therapist of any reactions.

10.3 StatUS

10.3.1 Connecting the StatUS-applicator


Make sure that the logo of the ATUS-controller is
pointing upward.
Plug in the left plug of the ATUS-controller in
connection B of the UG-module [1].
Connect the right plug to the StatUS-module [2].

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]

10.3.3 Applying the gel pad (gel cushion)


Place a gel pad in the ring (see photograph… ). The StatUS-applicator is now ready for use.
The gel pads are intended for once-only use. Instructions are supplied with the gel pads. Read
these carefully.

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

Headphone connector, (backside of the unit) for


the raw EMG signal

The connection with the MyoComBox is wireless


via Bluetooth. This is only possible if the X
module is integrated.

!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

11.1 Operator Controls


(See jacket flap)

[1] Standby button


With this push button the 6-series is switched between On and Standby.
Pushing this button for more than two seconds will reset the device.

[2] Connector for mains cable


To disconnect the device from the power line, unplug the power cord.

Type number/warning sticker


Provides information on the apparatus, such as type and serial number, as well as connection
data such as mains voltage and maximum current consumption.

[1] Selection button for:


Electrotherapy channel 1
Push the button to view or adjust all parameters of electrotherapy channel 1.

[2] Selection button for:


Electrotherapy channel 2.
Push the button to view or adjust all parameters of electrotherapy channel 2.

[3] Selection button for:


Ultrasound channel
Push the button to view or adjust all parameters of the ultrasound channel.

[4] Selection button for:


Optional module.

[5] Central controller


Use this controller to select menu items and to adjust all parameters including current amplitude
and ultrasound intensity.

[6] Confirmation button for:


Confirmation of all settings and selections.

[7] Assist button for:


Secondary functions, such as Stop, Home, Pause, Continue and Protocol Information. The
Assist button also provides access to the Vacotron module, when one is installed.

[8] Connection for Remote Control of Electrotherapy channels

[9] Connection Electrode Cable Electrotherapy channel 1

[10] Connection for additional accessories

[11] Connection Electrode Cable Electrotherapy channel 2

[12] Connection Ultrasound applicator A

[13] Connection Ultrasound applicator B

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

[14] Status LED


This lamp can indicate one of the following device states:
• Off Not connected to power line
• Yellow blinking Initializing
• Yellow continuous Standby
• Green blinking Performing self test
• Green continuous Ready for use

[15] Connections Vacuum Cables Electrotherapy channel 1

[16] Connections Vacuum Cables Electrotherapy channel 2

[17] Interconnection cable vacuum unit to main unit

[18] Electrotherapy output to vacuum unit

[21] Adjustable foot main unit

[22] Secure Digital memory card slot

[23] Vacuum hose between vacuum unit and main unit

[24] Water separation reservoir emptying hose

[25] Adjustable foot vacuum unit

11.2 Basic Operation

11.2.1 Turn on the apparatus

• Start the unit by pushing the standby button [19].


• 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.

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.

11.2.3 Home menu


Sonopuls 692
The Home menu gives Home
access to all functions of Therapy Wizard
the unit. Select the desired
function or therapy with the Electrotherapy
central controller [5] and Ultrasound Therapy
enter the next menu by
pushing the confirmation Combination Therapy
button [6].
System Settings

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]

• Select the treatment area with


the central controller [5] and
enter with the
confirmation button [6] Í Therapy Wizard
• To return to the home
menu, push the assist Body Part
button [7] and select Shoulder
Home menu.
Upper Arm
Elbow
Forearm
Hand
Hip
Thigh

• Select the treatment


with the central
controller [5] and enter
Í Therapy Wizard
with the confirmation
button [6] Application
Arthritis / Arthrosis High actuality
• Select the current
channels in the Arthritis / Arthrosis Low actuality
“Channel Selection”
(Sub)luxation acromioclavicular High
• 1+2 channels are
linked (Sub)luxation acromioclavicular Low actuality
• 1 independent channel (Sub)luxation glenohumeral High actuality
• 2 independent channel
(Sub)luxation glenohumeral Low actuality

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

• Select the desired


choice with the central Sonopuls 692
controller [5] and enter Home
with the confirmation
button [6] Therapy Wizard
Electrotherapy
Ultrasound Therapy
Combination Therapy
System Settings

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

• Select the desired current with Therapy Wizard


the central controller [5] and Pain Management
enter with the confirmation
button Premodulated
4-Polar Interferential
Biphasic Pulsed Current (TENS)
Faradic Current
Diadynamic Current
Galvanic Current
High Voltage

• Changing parameters Í Electrotherapy 1+2


• Select the parameter
with the central Pain Management
controller [5] and enter Premodulated
with the confirmation
button [6] Treatment Time 15:00
• The range of the Carrier Frequency 4.0 kHz
parameter is shown in
the pop-up screen. Beat Frequency 80 Hz
• Push the confirmation Frequency Modulation 0 Hz
button [6] to return
• Select other parameter Modulation Program 1/1 s
or start the therapy with Surge Mode
the intensity
 ► 12:45
15.0 mA 14.3 mA

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]

• Select New Session Í Electrotherapy


Diagnostics
New Session
Stored Session

• Select channel 2 Í Electrotherapy 2


• Select Search Probe
with the central New Session
controller [5] and enter Electrode selection
with the confirmation
button [6] Select On or Phase Interval 5s
Off. Rheobase / Chronaxie
• Read the information
on in the pop-up screen S/D Curve Rectangular
concerning the return S/D Curve Triangular
electrode. (use the
negative electrode as Report
return electrode) Beep

48
11.2.5.a.1 Rheobase/ Chronaxie

• Select Rheobase / Í Electrotherapy 2


Chronaxie with the
central controller [5] Diagnostics
and enter with the Electrode selection
confirmation button [6]
Phase Interval 5s
Rheobase / Chronaxie
S/D Curve Rectangular
S/D Curve Triangular
Report
Beep

mA

• Start with the Í Diagnostics 2


Rheobase. The phase
duration is fixed on Rheobase / Chronaxie
500ms. Rheobase
• To start push the
confirmation button [6]
you activate the 500 ms
intensity setting. Use
the central controller [5]
to adjust the intensity. Chronaxie
• Confirm the value by
pushing the
confirmation button [6]
• Repeat by pushing the
confirmation button [6]
again. 5.0 mA

• Select Chronaxie with Í Diagnostics 2


the central controller [5]
and confirm with the Rheobase / Chronaxie
confirmation button [6] Rheobase
• The retrieved intensity
in the Rheobase will be
doubled automatic. 500 ms
• Adjust the Phase
duration with the
central controller [5] Chronaxie
until the muscle
contract.
1000 µs

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

11.2.5.a.2 S/D Curve


Í Electrotherapy 2

• Select S/D Curve Diagnostics


Rectangular with the
central controller [5]
Electrode selection
and enter with the Phase Interval 5s
confirmation button [6]
Rheobase / Chronaxie
S/D Curve Rectangular
S/D Curve Triangular
Report
Beep
• Select the phase
duration with the
central controller [5], mA
you can start on
highest (1000 ms) or
lowest value (50 µs) Í Diagnostics 2
• Push the confirmation S/D Curve Rectangular
button [6] you activate
the intensity setting. 1000 ms
• Use the central 700 ms
controller [5] to adjust
the intensity. 500 ms
• Every push on the 300 ms
special probe or every
beep will generate one 200 ms
pulse. 100 ms
• Confirm the value by
pushing the 70 ms
confirmation
button [6]
• Select the second the 5.0 mA
next phase duration
with the central controller in the list. To receive a correct calculation you need to select
minimum 10 different phase durations, always include 500 ms.
50 • Select “Í” (left corner) to return to the previous menu.
• Select S/D Curve Í Electrotherapy 2
Triangular with the
central controller [5] Diagnostics
and enter with the Type Electrode
confirmation button [6]
Beep
Rheobase / Chronaxie
S/D Curve Rectangular
S/D Curve Triangular
Report

mA

• Select the phase Í Diagnostics 2


duration with the
central controller [5], S/D Curve Triangular
you can start on 1000 ms
highest (1000 ms) or
lowest value (100 µs) 700 ms
• Push the confirmation 500 ms
button [6] you activate
the intensity setting. 300 ms
• Use the central 200 ms
controller [5] to adjust
the intensity. 100 ms
• Every push on the 70 ms
special probe or every
beep will generate one
pulse.
• Confirm the value by
5.0 mA
pushing the confirmation
button [6]
• Select the second the next phase duration with the central controller in the list. To receive a
correct calculation you need to select minimum 10 different phase durations, always include
500 ms.
• Select “Í” (left corner) to return to the previous menu.

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

11.2.6 Ultrasound therapy

• Using the central Sonopuls 692


controller [5], select
Ultrasound in the Home
Home menu. Therapy Wizard
• Enter the selection with
the confirmation button Electrotherapy
[6]. Ultrasound Therapy
Combination Therapy
System Settings

• Select personal Í Ultrasound Therapy


protocols or manual
settings with the central
controller [5] and enter Manual Settings
with the confirmation
button [6]. Personal Protocols
• Under personal
protocols we offer you
a range of treatment
suggestions.
• Under manual settings
you can adjust all
parameters.

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

11.2.7 Combination therapy

• Using the central Sonopuls 692


controller [5], select
Combination in the Home
main menu. Therapy Wizard
• Enter the selection with
the confirmation button Electrotherapy
[6]. Ultrasound Therapy
Combination Therapy
System Settings

• Select personal Í Combination Therapy


protocols or manual
settings with the central
controller [5] and enter Manual Settings
with the confirmation
button [6]. Personal Protocols
• Under personal
protocols you can
retrieve your stored
protocols.
• Under manual settings
you can adjust all
parameters..

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

11.2.8 StatUS Therapy

• Using the central Sonopuls 692 S


controller [5], select
StatUS Therapy in the Home
main menu. Therapy Wizard
• Enter the selection with
the confirmation button Electrotherapy
[6]. Ultrasound Therapy
Combination Therapy
StatUS Therapy
System Settings

A0:00
0.00 W/cm² 0

• Select personal Í StatUS Therapy


protocols or manual
settings with the central
controller [5] and enter Manual Settings
with the confirmation
button [6]. Personal Protocols
• Under personal
protocols you can
retrieve your stored
protocols.
• Under manual settings
you can adjust all
parameters..

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

• Using the central Í StatUS 3+4


controller [5], select a
parameter.
• Enter the selection with Treatment Time 7:00
the confirmation button
[6] Ultrasound Applicator B
• Adjust the parameter in Ultrasound Frequency 1 MHz
the pop-up with the
central controller [5] Duty Cycle 20 %
• The range of the Duty Cycle Modulation
parameter is shown in
the pop-up screen. Amplitude Modulation
• Push the confirmation Pulse Frequency 100 Hz
button to return.
• Push the selection B7:00
button [3] to adjust the
intensity from the
0.00 W/cm² 45
ultrasound

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

• Select in the pop-up Electrotherapy 1+2


with the central
controller [5] Vacuum
pressure Vacuum
Vacuum Pressure 0
Range 0
Hold Time 0.0 s

 15:00
0.0 mA 0.0 mA

• To start the vacuum Electrotherapy 1+2


unit, adjust the
pressure with the
central controller [5] Í Vacuum Pressure
• Push the confirmation
button to return

 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)

11.2.9.b Vacuum electrode selection

• Using the central Í Electrotherapy 1+2


controller [5], select
electrode selection.
• Enter the selection with Premodulated
the confirmation button
[6] Treatment Time 15:00
Carrier Frequency 4.0 kHz
Electrode selection 
Beat Frequency 80 Hz
Frequency Modulation 0 Hz
Modulation Program 1/1 s
 15:00
0.0 mA 0.0 mA

• Select in the pop-up Electrotherapy 1+2


with the central
controller [5] electrodes
or Vacuum cups. Í Electrode Selection
• Push the confirmation
button to return.

 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.

11.2.10 Feedback Therapy

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.

• 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

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

Select manual settings


using the central regulator Feedback Therapy
[5] and press the
confirmation key [6].
Manual Settings
Personal Protocols
View Session Reports

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

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

• Select Continuous with Í Feedback Therapy 4


the central controller [5]
and enter with the Myofeedback
confirmation button [6] Continuous
Exercise / Rest
Template
Continuous 1+2
Exercise / Rest 1+2
Template 1+2

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

• Using the central Í Myofeedback 4


controller [5], to select
a parameter, select by Continuous - Settings
pushing the Treatment Time 10:00
confirmation button [6].
• Change the value with Sensitivity 200 µV
the central controller Shift 0 µV
• Go to Record to start
treatment and Threshold 0 µV
registration Graph
Sound
Record
„ 0:00 • „ 0:00 E1 „10:00
0.0 mA 0.0 mA

59
• Treatment and Í Myofeedback 4
registration runs
Continuous – Record
Note!
Following parameters are
adjustable during the
treatment:
• Sensitivity
• Shift
• Threshold

• Stop the training via


the assist button or
wait until the training is
finished. „ 0:00 • „ 0:00 E1 f09:45
• Go one step back and
select analyze or 0.0 mA 0.0 mA 85 µV
report.
• Store these data via the assist button on a USB stick. This only possible in combination with
the MyoComBox

• The final result screen Myofeedback


depends on the
selected exercises Continuous - Report
parameters Minumum 304 µV
• The parameters
included can be stored Maximum 355 µV
on the internal
Average 319 µV
memory on the unit.
• Graph and figures can Total recording time 0:25
only be exported to an
USB stick via the
Myocombox.

 15:00  15:00
0.0 mA 0.0 mA

11.2.10.a Connecting to the MyoComBox


A device with a feedback therapy module has some special settings.
In order to be able to work with the MyoComBox the device has to be connected to the
MyoComBox by means of the “System Settings.”

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.

11.2.10.b Exporting Reports and Measuring Data


Prepare your USB memory stick for use on your computer. Create the files in which you wish to
save the export. We recommend that you name the folder the same name as the name of the
patient.

Insert your USB memory stick into the MyoComBox.

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.

11.2.10.c Sensitivity setting

• Using the central Í Myofeedback 4


controller [5], to select
Sensitivity and push Continuous - Settings
the confirmation button Treatment Time 10:00
[6].
Sensitivity 200 µV
Shift 0 µV
Threshold 0 µV
Graph
Sound
Record
„ 0:00 • „ 0:00 E1 „10:00
0.0 mA 0.0 mA

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

Sensitivity can also be


change during the
treatment
„ 0:00 • „ 0:00 E1 f09:45
0.0 mA 0.0 mA 85 µV

Í Myofeedback 4
Sensitivity setting during
treatment. Continuous - Record

• Push the confirmation


button [6] and change
the value with the
central controller [5]
and push the
confirmation button [6]
again to return

„ 0:00 • „ 0:00 E1 f09:45


0.0 mA 0.0 mA 85 µV
11.2.10.d Threshold Setting

• Using the central Í Myofeedback 4


controller [5], to select
Threshold and push Continuous - Settings
the confirmation button Treatment Time 10:00
[6].
Sensitivity 200 µV
Shift 0 µV
Threshold 0 µV
Graph
Sound
Record
„ 0:00 • „ 0:00 E1 „10:00
0.0 mA 0.0 mA

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

Sensitivity can also be


change during the
treatment „ 0:00 • „ 0:00 E1 f09:45
0.0 mA 0.0 mA 85 µV

Threshold setting during Í Myofeedback 4


treatment
• Select the Threshold Continuous - Record
icon with the central
controller [5]

„ 0:00 • „ 0:00 E1 f09:45


0.0 mA 0.0 mA 85 µV

• Push the confirmation Í Myofeedback 4


button [6] and change
the value with the Continuous - Record
central controller [5]
and push the
confirmation button [6]
again to return

„ 0:00 • „ 0:00 E1 f09:45


0.0 mA 0.0 mA 85 µV

63
11.2.10.e Exercise / Rest

• Select Exercise / Rest Í Feedback Therapy 4


with the central
controller [5] and enter Myofeedback
with the confirmation Continuous
button [6]
Exercise / Rest
Template
Continuous 1+2
Exercise / Rest 1+2
Template 1+2

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

• Using the central Í Myofeedback 4


controller [5], to select
Threshold and push Exercise / Rest - Settings
the confirmation button Exercise Time 0:10
[6].
Rest Time 0:05
Adjust: Cycles 5
• Exercise Time in sec
• Rest Time in sec Sensitivity 200 µV
• Cycles (amount of Shift 0 µV
repetitions)
• Sensitivity Threshold 0 µV
Graph
Go to record to start the
treatment „ 0:00 • „ 0:00 E1 „ 01:15
0.0 mA 0.0 mA

White area is the Exercise Í Myofeedback 4


time
Green area is the Rest Exercise / Rest - Record
time

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.

„ 0:00 • „ 0:00 E1 f01:05


0.0 mA 0.0 mA 65 µV
64
11.2.10.f Template

• Select Template with Í Feedback Therapy 4


the central controller [5]
and enter with the Myofeedback
confirmation button [6] Continuous
Exercise / Rest
Template
Continuous 1+2
Exercise / Rest 1+2
Template 1+2

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

• Using the central Í Myofeedback 4


controller [5], to select
Threshold and push Template - Settings
the confirmation button Template
[6].
Template Time 0:05
Adjust: Rest Time 0:05
• Template
• Template Time in sec Cycles 5
• Rest Time in sec Sensitivity 200 µV
• Cycles (amount of
repetitions) Shift 0 µV
• Sensitivity Template Height 70 %
• Template Height
(feedback on screen) „ 0:00 • „ 0:00 E1 „ 01:15

Go to record to start the


0.0 mA 0.0 mA
treatment.

The template form is Í Myofeedback 4


displayed in orange as the
guide line for the patient to Template
follow.

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.

„ 0:00 • „ 0:00 E1 f01:05


0.0 mA 0.0 mA 5 µV 65
11.2.10.g Shift

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.

The adjustment is as follow:


• Define the ideal bandwidth in the sensitivity setting screen.
• Set the sensitivity back to the ideal bandwidth, the signal will disappear in the graphic.
Go back to the setting menu and select Shift.
• Scroll with the shift until the signal is back on the screen. The sensitivity range is much
lower and only for a limited range.

Note! Í Myofeedback 4
• The shift range is
linked to the Sensitivity Continuous - Shift
setting.

„ 0:00 • „ 0:00 E1 f01:05


0.0 mA 0.0 mA 305 µV
11.2.10.h Myofeedback + Stimulation

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

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA
• Select Myofeedback Í Feedback Therapy
+stimulation with the
central controller [5]
and enter with the Myofeedback
confirmation button [6].
Myofeedback + Stimulation
Pressure
Pressure + Myofeedback
Stored Sessions

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

11.2.10.i Alternating

• Select Alternating with Í Feedback Therapy 4


the central controller [5]
and enter with the Myofeedback + Stimulation
confirmation button [6] Alternating
Stimulation above Threshold
Stimulation below Threshold
Alternating 1+2
Stimulation above Threshold 1+2
Stimulation below Threshold 1+2

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

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

„ 0:00 • „ 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 Alternating – 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 0 µV
• All stimulation
parameters. E1 • „ 0:00 E1 „ 01:15

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.

11.2.10.j Stimulation above Threshold

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.

• Select Stimulation Í Feedback Therapy 4


above Threshold with
the central controller [5] Myofeedback + Stimulation
and enter with the Alternating
confirmation button [6]
Stimulation above Threshold
Stimulation below Threshold
Alternating 1+2
Stimulation above Threshold 1+2
Stimulation below Threshold 1+2

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]

Go to record to start the treatment.

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.

11.2.10.k Stimulation below Threshold

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.

• Select Stimulation Í Feedback Therapy 4


below Threshold with
the central controller [5] Myofeedback + Stimulation
and enter with the Alternating
confirmation button [6]
Stimulation above Threshold
Stimulation below Threshold
Alternating 1+2
Stimulation above Threshold 1+2
Stimulation below Threshold 1+2

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

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

„ 0:00 • „ 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 below 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 „ 0:00 • „ 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]

Go to record to start the treatment.

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.

• 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

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

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

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA
• Select Continuous with Í Feedback Therapy 4
the central controller [5]
and enter with the Pressure
confirmation button [6] Continuous
Exercise / Rest
Template

„ 0:00 • „ 0:00 E1 „10:00


0.0 mA 0.0 mA

• Using the central Í Pressure 4


controller [5], to select
a parameter, select by Continuous - Settings
pushing the Treatment Time 10:00
confirmation button [6].
• Change the value with Sensitivity P 120 hPa
the central controller Zero
• If the setoff value is to
high or not wanted, use Threshold P 0.0 hPa
the Zero setting to Graph
reset the value to zero.
Push the confirmation Sound
button reset! Record
• Go to Record to start
treatment and „ 0:00 • „ 0:00 P „10:00
registration
0.0 mA 0.0 mA

74
• Treatment and Í Myofeedback 4
registration runs
Continuous – Record
Note!
Following parameters are
adjustable during the
treatment:
• Sensitivity P
• Shift P
• Threshold P

„ 0:00 • „ 0:00 P f09:45


0.0 mA 0.0 mA 85 µV
11.2.10.m EMG feedback with 2 channels
The adjustment for two channels is the same as the adjustment for one channel. The feedback
is always for both channels as bar, curve ore combined curve visual in the display.
The real-time value will be showing in de display (in the right tab) as follow:
• E1 is for channel 1
• E2 is for channel 2
To change the read-out value in the display between EMG channel 1 and 2:
• Push the button [4] and change the read-out with the central controller [5] between E1
and E2.

11.2.10.n Analyze

At the end of the treatment Í Pressure 4


go to Analyze with the
central controller [5] and Continuous - Settings
push the confirmation Sensitivity P 120 hPa
button [6]
Zero
Threshold P 0.0 hPa
Graph
Sound
Record
Analyze
„ 0:00 • „ 0:00 P „ 0:00
0.0 mA 0.0 mA

75
Select the cursor ef and Í Pressure 4
push the confirmation
button [6]. Continuous – Analysis

„ 0:00 • „ 0:00 P „00:00


0.0 mA 0.0 mA

Move the cursor line with Í Pressure 4


the central controller [5]
and accept with the Continuous – Analysis
confirmation button [6]

„ 0:00 • „ 0:00 P „00:00


0.0 mA 0.0 mA

Select the loupe with the Í Pressure 4


central controller [6] and
push the confirmation Continuous – Analysis
button [6].

Change the timeline with


the central controller to
zoom in on the area.

„ 0:00 • „ 0:00 P „00:00


Go back to the previous
screen to select report. 0.0 mA 0.0 mA

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

The displayed results are Í Pressure 4


from the complete session.
Continuous - Report
To transfer these Minimum 0.0 hPa
parameters you need to
have the X module and the Maximum 122.6 hPa
MyoComBox
Average
Total execution time 0:30 s

„ 0:00 • „ 0:00 P „ 0:00


0.0 mA 0.0 mA

77
11.2.11 System Settings

• Using the central Sonopuls 692


controller [5], select
System Settings in the Home
Home Menu Therapy Wizard
• Enter the selection with
the confirmation button Electrotherapy
[6]. Ultrasound Therapy
Combination Therapy
System Settings

• Select the desired Í System Settings


setting with the central
controller [5].
• Enter the selection with Language English
the confirmation button
[6]. LCD brightness 100
• Adjust the setting in the Speaker Volume 88
pop-up screen with the
central controller [5]. Default Settings
• The range of the Ultrasound Standard USA
parameter is shown in
the pop-up screen. System Info V019
• Push the confirmation Service
button [6] again to
return.
• Return to the Home
menu.

11.2.11.a Change Language


• Go to System Settings in the Home menu
• Push the confirmation button [6] and select Language with the central controller [5].
• Push the confirmation button [6] and select the desired Language in the list with the
central controller [5]. Confirm the new language by pushing the confirmation button [6]
• The unit will reboot automatically

11.2.11.b Backup -and restore personal data


• Go to System Settings in the Home menu
• Push the confirmation button [6] and select Service with the central controller [5].
• Insert a SD card in the card sleeve [2]
• Select Backup personal data with the central controller [5] to store the personal protocols
on the SD card or select restore personal protocols to restore the personal protocols
from the SD Card in the unit memory.

11.2.12 Special parameter settings


78
11.2.12.a Surge programs

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:

• A single treatment step of a protocol could contain a surge program.

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.

11.2.12.b Current amplitude


The current amplitude is adjusted using the central controller [5].
Select the channel by pushing knobs [1] or [2].
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 4.3 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].

11.2.12.c CC/CV mode


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.

11.2.12.d Current polarity


When DC currents are used, the red terminal is the positive terminal and the black one the
negative terminal.
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.

11.2.13 Ultrasound power/Amplitude


The ultrasound Amplitude is adjusted with the central controller [5]. Push the channel button [3]
and adjust the Amplitude with the central controller.
• The ultrasound Amplitude can only be adjusted when the clock has been set.

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.

11.3 Memory functions

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.

11.3.1 Protocols via Therapy Wizard

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.

11.3.1.a Loading a protocol


• In the Home menu, select Therapy Wizard with the central controller [5] and enter by
pushing the confirmation button [6]
• Select a protocol via Body Part, Applications or by a protocol number.
80 • Select a target channel in the Channel Selection menu. Select 1+2 if you want to link the
channels, causing the protocol to be run on both channels.
• The display shows the first treatment step of the selected protocol. The total treatment
time of the protocol is displayed in the channel tab.
• Optionally push the assist button [7] for information about the protocol, electrode
placement and other information.
• Start the treatment by adjusting the current amplitude with controller [5]
• Push assist button [7] and deactivate pause to start the therapy in case a surge program
was selected.

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.

11.3.1.b Storing a protocol

Prior to the execution of a Electrotherapy 1+2


modified protocol, it can be saved
for later use under Personal
protocols. Ã Assist
• Push assist button [7] and
select store with the central Stop 
controller [5] Unlink the channels
• Follow the instructions on the
screen.
Home
Store

 ► 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

12.1 User Maintenance

12.1.1 Cleaning of apparatus


To clean the unit, turn it off and unplug the power supply. Clean the unit with a damp cloth. Do
not use abrasive cleaners. A small amount of mild household detergent may be used, if needed.

12.1.2 Cleaning display panel


The display panel contains an anti-reflective coating, which needs special care when cleaned.
Use a soft and dry cotton cloth or micro fiber tissue to clean the panel. To remove fingerprints or
grease, use a non-abrasive glass cleaning agent. Apply a small amount of the cleaning agent to
a soft cotton cloth and than carefully clean the panel.

CAUTION:

• Do not spray the cleaning agent directly on the glass panel.


• Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride
or detergents with ammonia.
• Avoid touching the glass panel with your bare fingers.

12.1.3 Electrodes and accessories


Between patient uses, the rubber electrodes should be cleaned with lukewarm water. To
disinfect the electrodes or to remove stubborn stains of dirt, use a 70% alcohol solution. The
alcohol solution can cause the black color to be stained, but this does not affect the operation of
the electrodes.

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.

12.1.4 Patient cable


Clean the patient cable with a damp cloth. Use lukewarm water and a non-abrasive household
cleaner. Do not use an alcohol solution. Check the cable regularly for damages and/or bad
electrical contact. We advise, keeping a spare patient cable in stock.

12.1.5 Ultrasound applicator


To prevent corrosion, clean and dry the contact surface immediately after use. Make sure that
no ultrasound gel remains on the applicator. We further recommend cleaning the applicator and
cable daily, using lukewarm water. The applicator can be disinfected using a cloth moistened
with a 70% alcohol solution. Check the applicator and cable regularly for damage.

12.1.6 Cleaning of the StatUS Applicator (Stationary Ultrasound Head)

General
The treatment head and the cable must be regularly checked for damage such as hairline tears
which would allow fluid to penetrate.

Ultrasound Head Surface


Clean the contact surface of the stationary ultrasound head after each use.
The treatment heads may be disinfected with a moist cloth dipped in 70% alcohol solution.
83
Cable/Rubber Cup
We recommend cleaning the cable and the rubber cup daily with a moist cloth. Use lukewarm
water and a little household cleanser if necessary (no abrasives or no alcohol solutions).

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

12.1.7 Water reservoir of vacuum unit


Treatment unit
First switch off the unit and disconnect the mains. Remove the connection cable of the
electrotherapy unit. The unit can be cleaned with a damp cloth. Use lukewarm water and, if
required, a liquid household detergent. Do not use abrasive cleaners.

Electrodes and sponges


The vacuum electrodes and sponges should be cleaned with lukewarm water. In the case of
persistent dirt, and for disinfection, a 70% alcohol solution may be used.
Sponges should be replaced regularly. It is recommended to keep sponges and a spare
electrode in stock.

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.

Cleaning the water reservoir and hoses


Before you run the cleaning procedure, the peripheral ends of the vacuum tubes should be
placed in a cup with cleaning liquid (see below) so the Vacotron can be cleaned internally with
this liquid. After this turn the vacuum pump on to full power until the reservoir is full with cleaning
liquid. If the reservoir is full, empty it as described above.

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

12.2.1 Error code


When the apparatus is turned on, it will first execute a self test. When an error is detected, both
during the self test and during normal operation, a pop-up screen will appear on the display.
When the error is displayed, all outputs will be disabled. When this situation occurs, remove all
cables and switch the apparatus off and on again. When the error re-appears, stop using the
device and contact your supplier.

12.2.2 Insufficient or no output current


Insufficient or no output current is usually preceded by a blinking current display or pop-up
screen with warning messages

• Poor electrical contact or broken patient cable.


• Insufficiently moistened sponges. If necessary, use a saline solution to improve the
electrical conductivity of the water.
• Too high current amplitude with self adhesive electrodes. Try to continue the treatment
with flexible rubber electrodes.

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.

12.3 Technical Maintenance

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.

12.4 End of life

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 

13.1.4 Burst Asymmetrical Alternating 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 

13.3 Russian Stimulation 

fc Carrier frequency

fB Burst frequency




13.4 Micro Current

f Frequency

13.5 High Voltage


t Peak interval - 64 µs fixed

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

13.7.1 IG30 Monophasic

13.7.2 IG30 Biphasic

13.7.3 IG50 Monophasic

Envelope

91
13.7.4 IG50 Biphasic

Envelope

13.7.5 IG100 Monophasic

Envelope

13.7.6 IG100 Biphasic

Envelope

92
13.7.7 IG150 Monophasic

Envelope

13.7.8 IG150 Biphasic

Envelope

93
13.8 Faradic Pulsed Current

13.8.1 Triangular Pulsed Current


tp Phase duration

ti Phase interval


13.8.2 Triangular alternating current

tp Phase duration

ti Phase interval


13.8.3 Rectangular Pulsed current
tp Phase duration

ti Phase interval 

13.8.4 Rectangular alternating current

tp Phase duration

ti Phase interval I

13.9 Träbert, 2 – 5 Current 

tp Phase duration: 2 ms
ti Phase interval: 5 ms

13.10 Galvanic Current

13.10.1 Direct Current

13.10.2 MF (medium frequency)


Interrupted Current
f Carrier frequency - 8 kHz fixed

Duty cycle - 90 % fixed

94

13.11 Modulation program

13.11.1 Modulation program 1/1 fp Pulse frequency 

fm Frequency modulation 

13.11.2 Modulation program 6/6 or


12/12
6 : 6 or 12 : 12

fp Pulse frequency 

fm Frequency modulation

13.11.3 Modulation program 1/30


1 : 30

fp Pulse frequency 

fm Frequency modulation 

13.12 Surge program parameters

tr Ramp up time 

th Hold time

tf Ramp down 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:

fp Pulse frequency, 100 Hz fixed

t Pulse duration, set by duty cycle

5 – 80 % and 100 % (100% is


continuous wave)

t 0.5 – 8 ms

RTPA 20 – 1.25
14 Specifications

14.1 Ultrasound parameters


See fig 13.14 for details.

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)

Peak output power for 5 cm² applicator:


Duty cycle 5 – 50 % : 0 – 15 W
Duty cycle 80 % : 0 – 12 W
Duty cycle 100 % : 0 – 10 W (continuous wave)

Peak output power for 0.8 cm² applicator:


Duty cycle 5 – 50 % : 0 – 2.4 W
Duty cycle 80 % : 0–2W
Duty cycle 100 % : 0 – 1.6 W (continuous wave)

Output meter uncertainty : ± 20 % for any output above 10 % of maximum

Pulse frequency : 100 Hz ± 1 % fixed


Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA):20 – 1.25 ± 10 % (set by duty cycle)

Treatment timer : 0 - 30 min ± 0.1 min, linked to contact control


Contact control level : 65%

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

0.8 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 : to be determined
21 CFR 1050.10 : to be determined

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.

14.2 Stimulator output parameters

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

Dipole Vector Automatic


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
Amplitude : 0 - 100 mA
Rotation time : 1 - 10 s in steps of 1 s
Current mode : CC
Dipole Vector Manual
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
Resolution vector : 2.25° per step (160 steps over 360°)
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 Asymmetrical Alternating


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.
98 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
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 - 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

High Voltage (Twin Pulse)


Frequency : 1- 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum): 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Surge Program : Yes
Polarity : Positive or Negative
Amplitude : 0 – 500 Volt in steps of 1V

High Voltage Alternating (Twin Pulse)


Frequency : 1 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz, sum of Pulse frequency and
Frequency Modulation can not exceed 200 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Alternating Period : 10 -100 seconds in steps of 10
Ramp-in, ramp out : 0,5 seconds
Amplitude : 0 – 500 Volt in steps 1 Volt

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

Micro Current Alternating


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
Alternating Period : 0,2 – 20 seconds, 0,2 – 1 s in steps of 0,1s., 1 – 20 s in
steps of 1 s.
Ramp-in, ramp out : 0 seconds
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

MF interrupted galvanic current


Frequency : 8000 Hz
Duty cycle : 95%
Polarity : Positive or Negative
Amplitude : 0 - 40 mA

Direct Galvanic current


Polarity : Positive or Negative
Amplitude : 0 – 40 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

Faradic Triangular Pulsed Current


Phase duration : 0.1 – 1000 ms
Phase interval : 5 – 15000 ms
Surge program : Yes
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

Träbert 2-5 (Rectangular pulsed current)


Phase duration : 2 ms
Interval : 5 ms
Polarity : Positive or Negative
Amplitude : 0 - 80 mA

IG Currents (Impulse Galvanisation) Monophasic


Waveform : IG30, IG50, IG100, IG150
Polarity : Positive or Negative
Amplitude : 0 – 80 mA

IG Currents (Impulse Galvanisation) Biphasic


Waveform : IG30, IG50, IG100, IG150
Amplitude : 0 – 80 mA

14.3 Vacuum unit (Vacotron)

Vacuum pressure : 10- 90 (0 – 600 mbar), continuously adjustable


Pulsed vacuum via vacuum range: adjustable from 10 – 80%
Hold time : 0 – 2,5 seconds in steps of 0,5 second

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

Pressure : 1 channel via internal sensor


Range : 0 – 360 hPa

101
14.5 Safety and Performance standards

IEC 60601-1 : General requirements for the safety of electrical medical


systems, including Annex 1, national differences for
Australia, Canada and the United States.

Safety class according to IEC 60601-1: class I type BF

IEC 60601-2-5 : Particular requirements for the safety of ultrasonic


therapy equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and
muscle stimulators.
IEC 60601-2-40 : Particular requirements for the safety of
electromyographs and evoked response equipment.

: This equipment complies with all requirements of the


Medical Device Directive (93/42/EEC).
Medical device classification : IIa

21 CFR 1050.10 : This equipment complies with all requirements of 21


CFR 1050.10, Performance Standard for Ultrasonic
Therapy devices.

21 CFR 898 : This equipment complies with all requirements of 21


CFR 898, Performance Standard for electrode lead
wires and patient leads.

102
14.6 EMC details

Guidance and manufacturer’s declaration – electromagnetic immunity


The 6-series is intended for use in the electromagnetic environment specified below. The
customer or the user of the 6-series should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic
test level environment –
guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
discharge (ESD) ± 8 kV air ± 8 kV air concrete or
IEC 61000-4-2 ceramic tile. If floors are
covered with
synthetic material, the
relative humidity
should be at least 30 %.
Electrical fast ± 2 kV for power ± 1 kV for power Mains power quality
transient/burst supply lines supply lines should be that of a
IEC 61000-4-4 ± 1 kV for not applicable typical computer room.
input/output
Lines
Surge ± 1 kV line(s)to ± 1 kV line(s)to Mains power quality
IEC 61000-4-5 line(s) line(s) should be that of a
± 2 kV line(s)to earth ± 2 kV line(s)to earth typical computer room.
Voltage dips, short <5 %U T < 5% UT Mains power quality
interruptions and (>95 %dip in U T) for 0,5 cycle should be that of a
voltage variations for 0,5 cycle typical computer room.
on power supply 40 %U T < 5% UT If the user of the
input lines (60 %dip in U T) for 1 cycle 600-series requires
IEC 61000-4-11 for 5 cycles continued operation
70 % U T 70% UT during power mains
(30 %dip in U T) for 25 cycles interruptions, it is
for 25 cycles recommended
<5 % U T < 5% UT that the 600-series be
(>95 %dip in U T) For 5 sec. powered from an
for 5 sec uninterruptible power
supply or a battery.
Power frequency 3 A/m 3A / m Power frequency
(50/60 Hz) magnetic fields should
magnetic field be at levels
IEC 61000-4-8 characteristic of a
typical location in a
typical computer room.
NOTE U T is the a.c.mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity


The 6-series is intended for use in the electromagnetic environment specified below. The 103
customer or the user of the 6-series should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Electromagnetic environment –
level guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
6-series, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF 3 Vrms 3 V Recommended separation
IEC 61000-4-6 150 kHz to 80 MHz distance

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

d = [7/3]√P 800 MHz to 2,5 GHz

where P is the maximum output


power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b Interference
may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
A Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the 6-series is used exceeds the
applicable RF compliance level above, the 6-series should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the 6-series.
B Over the frequency range 15 kHz to 8 MHz, field strengths should be less than 3 V / m.

Recommended separation distances between portable and mobile RF communications


equipment and the 6-series
The 600-series is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 6-series can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the 6-series as recommended below,

104 according to the maximum output power of the communications equipment.


Rated Separation distance according to frequency of transmitter
maximum [m]
output power 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2,5 GHz
of transmitter d = [3,5/V1]√P MHz d = [7/E1]√P
d = [3,5/E1]√P
[W]
0,01 0,12 0,12 0,23
0,1 0,37 0,37 0,74
1 1,17 1,17 2,33
10 3,69 3,69 7,38
100 11,67 11,67 23,33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

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

14.7 Technical Data

Mains voltage : 100 – 240 V ± 10%


Mains frequency : 50 / 60 Hz

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

Environmental conditions for transport and storage:


Temperature : -10° to +50° C
Relative humidity : 10 to 100 % (contained in original packaging)
Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use:


Temperature : 10° to 40° C
Relative humidity : 10 to 90 % non condensing
Atmospheric pressure : 500 to 1060 hPa

Technical modifications reserved

105

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