Enraf Nonius 6 Series User manual

6-series
User Manual

Copyright:
Enraf-Nonius B.V.
Vareseweg 127
3047 AT Rotterdam
The Netherlands
Tel: [phone]
Fax: [phone]
[email protected]
www.enraf-nonius.com
Part number: 1600.751_4D
November 27th, 2019

6-series
User Manual

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1600751-4D

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Contents
1PRODUCT DESCRIPTION ...............................................................................................9
1.1 Endomed electrotherapy module...................................................................................9
1.2 Sonopuls ultrasound module.........................................................................................9
1.2.1 StatUS module ........................................................................................................................................9
1.3 Vacotron vacuum module...............................................................................................9
1.4 EMG module ..................................................................................................................10
2FOREWORD...................................................................................................................11
2.1 This manual ...................................................................................................................11
2.2 Product liability .............................................................................................................11
3PRECAUTIONARY INSTRUCTIONS .............................................................................12
3.1 WARNING: .....................................................................................................................12
3.2 CAUTION: ......................................................................................................................12
3.3 Symbols.........................................................................................................................14
4INTENDED USE: ELECTROTHERAPY..........................................................................15
4.1 Pain Management..........................................................................................................15
4.1.1 Indications/Contraindications.................................................................................................................15
4.1.2 Current Waveforms ...............................................................................................................................15
4.2 Muscle Stimulation........................................................................................................16
4.2.1 Indications/Contraindications and Adverse Effects for Muscle Stimulation............................................16
4.2.2 Current Waveforms ...............................................................................................................................17
4.3 Description: Current Waveforms .................................................................................17
4.3.1 4 Pole Interferential Currents.................................................................................................................17
4.3.1.a Classical Interferential ........................................................................................................................17
4.3.1.b Isoplanar Vector .................................................................................................................................18
4.3.1.c Dipole Vector Manual .........................................................................................................................18
4.3.1.d Dipole Vector Automatic .....................................................................................................................18
4.3.2 Biphasic Pulsed Currents (TENS) .........................................................................................................19
4.3.2.a Asymmetrical and Alternating Asymmetrical.......................................................................................19
4.3.2.b Burst Asymmetrical and Burst Alternating Asymmetrical....................................................................20
4.3.2.c Symmetrical........................................................................................................................................20
4.3.2.d Burst Symmetrical ..............................................................................................................................21
4.3.3 Premodulated ........................................................................................................................................21
4.3.4 Russian Stimulation...............................................................................................................................22
4.3.5 Micro Current.........................................................................................................................................22
4.3.6 High Voltage..........................................................................................................................................23
4.3.7 Diadynamic Currents.............................................................................................................................23
4.3.7.a MF (Monophasé Fixe) ........................................................................................................................24
4.3.7.b DF (Diphasé Fixe) ..............................................................................................................................24
4.3.7.c LP (Longues Périodes).......................................................................................................................24
4.3.7.d CP (Courtes Périodes)........................................................................................................................24
4.3.7.e CPid....................................................................................................................................................24
4.3.8 IG Pulsed Currents................................................................................................................................24
4.3.9 Galvanic Current ...................................................................................................................................24
4.3.9.a Direct Galvanic Current ......................................................................................................................24
4.3.9.b MF Interrupted Galvanic Current ........................................................................................................25
4.3.10 Faradic Rectangular or Triangular pulsed current .................................................................................25
4.3.11 Träbert, 2 –5 Current............................................................................................................................26

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4.4 The Strength-Duration Curve (SD Curve).................................................................... 26
5INTENDED USE ULTRASOUND THERAPY AND STATUS.......................................... 27
5.1 Ultrasound..................................................................................................................... 27
5.1.1 Indications/Contraindications and Adverse Effects for Ultrasound ........................................................27
5.1.2 Parameters............................................................................................................................................28
5.2 Combination Therapy ................................................................................................... 28
5.3 StatUS Therapy ............................................................................................................. 28
6INTENDED USE VACUUM............................................................................................. 30
7INTENDED USE MYOFEEDBACK ................................................................................ 30
7.1 Parameters .................................................................................................................... 30
7.2 Indications/Contraindications and Adverse Effects for Myofeedback...................... 31
8PACKAGE CONTENTS ................................................................................................. 32
8.1 Standard Accessories electrotherapy 682 –692 - 632 ............................................... 32
8.2 Standard Accessories electrotherapy 684 .................................................................. 32
8.3 Standard Accessories ultrasound 690 - 692 ............................................................... 32
8.4 Standard Accessories Vacuum 682V –692V –632V .................................................. 32
8.5 Standard Accessories Vacuum 684V .......................................................................... 33
8.6 Standard Accessories StatUS...................................................................................... 33
8.7 Standard Accessories EMG 632 .................................................................................. 33
8.8 Optional Accessories ................................................................................................... 33
9INSTALLATION ............................................................................................................. 34
9.1 Units without a Vacotron module ................................................................................ 34
9.2 Units with a Vacotron module...................................................................................... 34
9.3 Connection to mains supply ........................................................................................ 34
10 APPLICATION NOTES .................................................................................................. 35
10.1 Electrotherapy............................................................................................................... 35
10.1.1 Before treatment....................................................................................................................................35
10.1.2 Flexible rubber electrodes .....................................................................................................................35
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.......................................................................................................................................38

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10.3 StatUS ............................................................................................................................38
10.3.1 Connecting the StatUS- StatUS applicator / ultrasound treatment head ...............................................38
10.3.2 Applying the fixation ..............................................................................................................................39
10.3.3 Applying the gel pad (gel cushion).........................................................................................................39
10.4 EMG................................................................................................................................40
10.4.1 Connections ..........................................................................................................................................40
11 OPERATING INSTRUCTIONS .......................................................................................41
11.1 Operator Controls .........................................................................................................41
11.2 Basic Operation.............................................................................................................42
11.2.1 Turn on the apparatus ...........................................................................................................................42
11.2.2 Navigation and display organization......................................................................................................43
11.2.3 Home menu...........................................................................................................................................43
11.2.4 Therapy Wizard .....................................................................................................................................44
11.2.5 Electrotherapy .......................................................................................................................................45
11.2.5.a Diagnostics.........................................................................................................................................47
11.2.6 Ultrasound therapy ................................................................................................................................51
11.2.7 Combination therapy .............................................................................................................................52
11.2.8 StatUS Therapy.....................................................................................................................................53
11.2.9 Vacuum adjustment via Assist button....................................................................................................55
11.2.9.a Vacuum pulsed mode.........................................................................................................................56
11.2.9.b Vacuum electrode selection................................................................................................................56
11.2.9.c Default Setting Vacuum Module .........................................................................................................57
11.2.10 Feedback Therapy.................................................................................................................................57
11.2.10.a Connecting to the MyoComBox..........................................................................................................59
11.2.10.b Exporting Reports and Measuring Data..............................................................................................60
11.2.10.c Sensitivity setting................................................................................................................................60
11.2.10.d Threshold Setting ...............................................................................................................................61
11.2.10.e Exercise / Rest ...................................................................................................................................63
11.2.10.f Template.............................................................................................................................................64
11.2.10.g Shift ....................................................................................................................................................65
11.2.10.h Myofeedback + Stimulation ................................................................................................................65
11.2.10.i Alternating ..........................................................................................................................................66
11.2.10.j Stimulation above Threshold ..............................................................................................................68
11.2.10.k Stimulation below Threshold...............................................................................................................70
11.2.10.l Pressure .............................................................................................................................................72
11.2.10.m EMG feedback with 2 channels ..........................................................................................................74
11.2.10.n Analyze...............................................................................................................................................74
11.2.10.o Report.................................................................................................................................................76
11.2.11 System Settings ....................................................................................................................................77
11.2.11.a Change Language ..............................................................................................................................77
11.2.11.b Backup -and restore personal data.....................................................................................................77
11.2.12 Special parameter settings ....................................................................................................................77
11.2.12.a Surge programs..................................................................................................................................77
11.2.12.b Current amplitude ...............................................................................................................................78
11.2.12.c CC/CV mode ......................................................................................................................................79
11.2.12.d Current polarity ...................................................................................................................................79
11.2.13 Ultrasound power/Amplitude .................................................................................................................79
11.3 Memory functions .........................................................................................................79
11.3.1 Protocols via Therapy Wizard................................................................................................................79
11.3.1.a Loading a protocol ..............................................................................................................................79
11.3.1.b Storing a protocol ...............................................................................................................................80
12 MAINTENANCE AND TROUBLESHOOTING ................................................................82
12.1 User Maintenance .........................................................................................................82
12.1.1 Cleaning of apparatus ...........................................................................................................................82
12.1.2 Cleaning display panel ..........................................................................................................................82
12.1.3 Electrodes and accessories...................................................................................................................82
12.1.4 Patient cable..........................................................................................................................................82
12.1.5 Ultrasound treatment head....................................................................................................................82
12.1.6 Cleaning of the StatUS Applicator (Stationary Ultrasound Treatment Head).........................................82
12.1.7 Water reservoir of vacuum unit..............................................................................................................84
12.2 Troubleshooting............................................................................................................85

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12.2.1 Error code .............................................................................................................................................85
12.2.2 Insufficient or no output current.............................................................................................................85
12.3 Technical Maintenance................................................................................................. 85
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
13.3Russian 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

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14 SPECIFICATIONS ..........................................................................................................96
14.1 Ultrasound parameters .................................................................................................96
14.2 Stimulator output parameters ......................................................................................97
14.3 Vacuum unit (Vacotron)..............................................................................................101
14.4 EMG..............................................................................................................................101
14.5 Safety and Performance standards ...........................................................................101
14.6 EMC details..................................................................................................................102
14.7 Technical Data.............................................................................................................104

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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 treatment heads for the 6-series provide both 1 and 3 MHz operation. The ultrasound
treatment heads can be used with both, large and small treatment surfaces and are suitable for
subsequent 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
ultrasound treatment head (= stationary). In the normal course of events, ultrasound energy is
administered by moving (‘making circles’) the ultrasound treatment head. This moving of the
ultrasound 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.

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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

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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.

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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.
3.1 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.
Keep portable radios and mobile phones at a distance of at least 1 meter from the device
during ultrasound therapy treatment.
3.2 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 the StatUS applicator / ultrasound treatment head with care. Inappropriate
handling of the StatUS applicator / ultrasound treatment head may adversely affect its
characteristics.
Inspect the StatUS applicator / ultrasound treatment head for cracks which may allow the
ingress of conductive fluid before each use.
Inspect the StatUS applicator / ultrasound treatment head cables and associated
connectors before each use.
Do not operate the 6-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,

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contraindications, warnings and precautions. Consult other resources for additional
information regarding the application of electrotherapy.

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3.3 Symbols
Follow the instructions in the Instructions for Use.
It is important that you read, understand and observe the precautionary and
operating instructions
Warning or Caution:
Indicates a hazardous situation which, if not avoided, could result in:
a. Death or serious injury to the patient (or)
b. Minor to moderate injury to the patient (or)
c. Damage to the equipment
No activated mobile phone.
Keep portable radios and mobile phones at a distance of at least 1 meter from the
device during ultrasound therapy treatment.
Type BF applied part.
Temperature Range.
Indicates acceptable temperature range
Humidity Limits.
Indicates acceptable relative humidity
Atmospheric Pressure.
Indicates the range of atmospheric pressure to which the medical device can be
safely exposed.
Keep the device dry.
Manufacturer name, address and date of manufacture.
Reference Number or Part Number.
Serial Number.
Indicates the serial number so that a specific medical device can be
identified.
Waste electrical items that can be recycled.
Indicates the electrical and electronic components of the device can be recycled
and has to be disposed separately.

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

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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.
•Dysphagia.
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 sinus carotid region (anterior neck) must
be avoided. However the application area for the treatment of Dysphagia is distant
enough from the sinus carotis area, when the therapist follows the guidelines as
described in the therapybook "Dysphagia (by H.C.A. Bogaardt SLP, PhD)"
•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:

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•Skin irritation and burns beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
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.

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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.