Sonuplus 492 Operator Manual

4-SERIES
It is important to read the following instructions carefully before using this device
properly and safely. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
If the use of this device may have caused or contributed to an undesirable event such as
death or serious injury to the user, the manufacturer AND the competent authority of the
Member State MUST be notified immediately!
EN109-1498751-47 IFU
January 16, 2020
Instructions for use
Page 1 of 72 EN109-1498751-47 IFU

Table of contents
1 Introduction ...................................................................................................................................................... 3
2 Symbols .............................................................................................................................................................. 5
3 Device components ....................................................................................................................................... 7
4 Package contents ......................................................................................................................................... 10
5 Installation ...................................................................................................................................................... 13
6 Intended use and intended user ............................................................................................................ 15
7 Indications ...................................................................................................................................................... 16
8 Contraindications ......................................................................................................................................... 17
9 Precautionary instructions ........................................................................................................................ 20
10 General instructions .................................................................................................................................... 21
11 Operation ........................................................................................................................................................ 23
12 Application information............................................................................................................................. 39
13 Description – Current waveforms and Ultrasound parameters .................................................. 42
14 Maintenance and troubleshooting........................................................................................................ 63
15 Specifications ................................................................................................................................................. 68
16 Contact ............................................................................................................................................................. 70
17 Product liability ............................................................................................................................................. 70
Page 2 of 72 EN109-1498751-47 IFU

1 Introduction
Foreword
Welcome to the growing family of new 4-series owners. This product is designed and manufactured
by Enraf-Nonius B.V. and is delivered to you with confidence. It was produced using the latest
techniques and strict quality control.
This manual has been written for the owners and operators of the 4-series. It contains general
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become
familiar with the controls as well as the accessories before operating the unit.
Device Description
The 4-series is a family of products for physical therapy. The devices share an identical control panel
equipped with a full colour touch panel. The devices are mains powered and can optionally be
equipped with a battery for mains independent operation. The family comprises the products
described below.
Endomed 482
The Endomed 482 is equipped with two completely identical electrotherapy channels. The
electrotherapy channels can be used in combination (linked) or independent. A comprehensive set of
current waveforms is available, targeting both pain management and muscle stimulation applications.
Protocol driven operation is available, providing both factory or user defined sequences of treatment
steps. Protocols can run on linked or independent channels. With independent channels two different
protocols can be performed simultaneously.
Sonopuls 490
The Sonopuls 490 is an ultrasound therapy device. The device provides two positions for attachment
of an ultrasound applicator. Depending on the device configuration ordered, the Sonopuls 490 comes
with an ultrasound head with a large contact area, an ultrasound treatment head with a small contact
area or with both applicators. The ultrasound head can operate in continuous or pulsed mode at an
ultrasound frequency of 1 MHz or 3 MHz Contact control suspends the application of ultrasonic
energy when acoustical contact with the treatment area becomes insufficient. The ultrasound heads
are suitable for subaqual treatments.
Sonopuls 492
The Sonopuls 492 is a combination device, combining the functions of the Endomed 482 and the
Sonopuls 490 in a single device. With the Sonopuls 492 the simultaneous application of ultrasound
and electrotherapy (combination therapy) is also possible. The remaining electrotherapy channel can
then be used independently.
StatUSTM Pack 400

For a detailed explanation about the installation and operation of the Sonopuls 490/492 in
combination with StatUS Pack 400 (for the application of static ultrasound), please refer to the
instructions for use StatUS Pack 400 (art. no. 1629.767). This manual (CD-ROM) is located in the
packaging of the StatUS Pack 400.
Vacotron 460
Electrotherapy can be applied through standard or vacuum electrodes. With vacuum electrodes, the
Vacotron 460 generates the vacuum through which the vacuum electrodes are attached to the patient.
Page 3 of 72 EN109-1498751-47 IFU

The device is placed beneath the Endomed 482 or Sonopuls 492, from which its power is derived and
through which it is also operated.
Page 4 of 72 EN109-1498751-47 IFU

2 Symbols
Symbol used Description
Follow the instructions in the Instructions for Use.

It is important that you read, understand and observe the precautionary and
operating instructions
General Prohibition Sign.

Prohibition is used to mean “You MUST NOT”
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
General mandatory action sign.

Mandatory action is used to mean, “You must…”
Type B applied part complying with the specified requirements to provide

protection against electric shock, particularly regarding allowable patient
leakage current and patient auxiliary current.
Type BF applied part complying with the specified requirements to provide a

higher degree of protection against electric shock than that provided by type B
applied parts.
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.
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.
Keep the device dry
Manufacturer name, address and date of manufacture.
Reference Number or Part Number
Page 5 of 72 EN109-1498751-47 IFU

Serial Number
Indicates the serial number so that a specific medical device can be
identified.
CE Mark along with number indicates conformity with European Council of

directive concerning Medical Devices and this device is under the direct
supervision of the Notified Body.
Connection electrode cable electrotherapy
Connections vacuum cables electrotherapy
Remote control connection
On/Off push button
Page 6 of 72 EN109-1498751-47 IFU

3 Device components
Parts of the device
Parts description
Numbered Description Purpose
Part
[1] Power line switch 0 Device disconnected from mains supply
1 Device connected to mains supply
[2] Connector for mains cable Connect supplied mains cable here to power the
device.
Type number/warning label Provides information on the apparatus, such as type

and serial number, as well as connection data such
as mains voltage and maximum current
consumption.
[3] Remote Control connection This connection has two functions.

1 Attachment of optional remote-control
unit. Used to remotely adjust the output
current on the electrotherapy channels or
to stop the treatment on all channels.
2 Attachment of a USB-stick. Used for
software updates and to backup and
restore user data.
Page 7 of 72 EN109-1498751-47 IFU

Part
Do not connect externally powered USB devices or

other information technology equipment as this can
adversely affect the safety of the patient.
The supply current of this connection is limited to

100 mA. Do not connect USB mass storage devices
such as USB powered hard disks, as this might result
in data loss. Only USB-sticks are allowed.
[4] On/Off push button: This button is used to turn the device On or Off.
[5] Power LED indicator: Green: Device connected to mains supply.

When a battery is present, it is
charged.
Orange: Device operating from battery
[6] Display with Touch screen User Interface that allows the operator to control the
technology: device and change parameters of treatment
protocols.
[7] Central controller with light ring Use this controller to scroll through the pages and
to adjust the parameters. The light ring is
illuminated when the controller is ready to use.
[8] Connection for Electrode Cable Connection point for the patient cable for Channel
Electrotherapy channel 1 1.
[9] Connection for Electrode Cable Connection point for the patient cable for Channel
Electrotherapy channel 2 2.
[10] Multifunctional Connector for Connection point to connect accessories such as
accessories Channel A Ultrasound head or StatUSTM Pack 400
[11] Multifunctional Connector for
accessories Channel B
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. For
combined applications only use Enraf-Nonius
Ultrasound Applicators. 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,
Page 8 of 72 EN109-1498751-47 IFU

Part
and must therefore be avoided.
[12] Connections Vacuum Cables Connection point for the Vacuum Patient leads for
Electrotherapy channel 1 Channel 1.
[13] Connections Vacuum Cables Connection point for the Vacuum Patient leads for
Electrotherapy channel 2 Channel 2.
[14] Interconnection cable vacuum Connection cable to connect the Vacuum unit with
unit to main unit the main unit.
[15] Upper hose nipple Air inlet for draining the Vacuum Tank. See
instructions Vacuum Unit.
Connections [8] [9] [12] [13] are intended for the connection of type BF applied parts
complying with the leakage current requirements of IEC 60601-1.
Connections [10] [11] are intended for the connection of type B applied parts complying with
the leakage current requirements of IEC 60601-1.
Page 9 of 72 EN109-1498751-47 IFU

4 Package contents
Device
The package contents depend on the device model ordered. The following models are available:
Part Number Description
1498.901 Sonopuls 490 with large ultrasound treatment head
1498.902 Sonopuls 490 with small ultrasound treatment head
1498.903 Sonopuls 490 with large and small ultrasound treatment head
1498.911 Sonopuls 492 with large ultrasound treatment head
1498.912 Sonopuls 492 with small ultrasound treatment head
1498.913 Sonopuls 492 with large and small ultrasound treatment head
1498.920 Endomed 482
1498.950 Vacotron 460
1629.902 StatUSTM Pack 400
Ultrasound treatment head

The ultrasound models can be supplied with one or two ultrasound treatment heads:
1630.905 Ultrasound Head Large
1630.915 Ultrasound Head Small
Standard accessories for 4-series

1498.010 Device base (inclination support) (not for Vacotron 460)
3440.001 Screwdriver
3444.290 Power cord 250V/10A Europe 2.5 meter black
1498.756 4-series Information Booklet
1498.757 4-series Instructions for Use (CD-ROM)
Standard accessories ultrasound

0167.154 Information sheet ultrasound gel
0167.314 Information sheet Mounting US Head Holder(s)
1498.011 Holder for Ultrasound Head 4-series - 1 for each ultrasound treatment head
3442.929 (*) Contact-gel, bottle 250 ml, 1x
(*) = The Sonopuls is delivered with 1 bottle of contact-gel. The article-number 3442.929 however
represents a box of 12 bottles.
Standard accessories electrotherapy

1460.266 Moist pads for rubber electrodes 6x8 cm, set of 4 pcs.
3444.020 Strap 100x3 cm
3444.021 Strap 250x3 cm
2 x 3444.129 Rubber electrodes 6x8 cm, 2 mm female, set of 2 pcs.
Page 10 of 72 EN109-1498751-47 IFU

2 x 3444.211 Patient cable 2-core & 2 mm male plugs - black, with coloured clips
Standard accessories vacuum

3444.505 Sponges Ø 65 mm, set of 4 (for vacuum electrodes Ø 60 mm)
2 x 3444.503 Vacuum electrodes Ø 60 mm, set of 2 pcs.
2 x 3444.507 Vacuum lead hose red
2 x 3444.508 Vacuum lead hose black
Optional accessories
Ultrasound contact-gel
3442.929 Contact-gel, bottle 250 ml, box of 12
3442.930 Contact-gel, bottle 850 ml, box of 12
3442.931 Contact-gel, canister of 5 L
3442.932 Dispenser-set for 5 L canister
Adhesive electrodes
3444.222 Adhesive electrodes Ø 2.0 cm, 2 mm female, 10 sheets of 8 (also for EMG)
3444.056 EN-Trode Ø 3.2 cm, 2 mm female, 10 sheets of 4
3444.135 EN-Trode Ø 5.0 cm, 2 mm female, 10 sheets of 4
3444.057 EN-Trode 5x5 cm, 2 mm female, 10 sheets of 4
3444.058 EN-Trode 5x9 cm, 2 mm female, 10 sheets of 4
Rubber electrodes
3444.128 Rubber electrodes 4x6 cm, 2 mm female, set of 2
Moist pads for rubber electrodes

1460.273 Moist pads for rubber electrodes 4x6 cm, set of 4
Fixation straps
3444.020 Strap 100x3 cm
3444.021 Strap 250x3 cm
3444.022 Strap 100x5 cm
Page 11 of 72 EN109-1498751-47 IFU

3444.023 Strap 250x5 cm
Point electrodes
3444.180 Point Electrode (pen model), 5 mm Ø, 2 mm female, incl 10 conductive rubber caps
Adapters
2523.524 Adapter plug, 2 mm female, 4 mm male, red
2523.523 Adapter plug, 2 mm female, 4 mm male, black
Patient cable
3444.211 Patient cable 2-core & 2 mm male plug - black, with colored clips
Remote control
1498.800 Remote control 4-series
Bag
3444.675 Carrierbag 4-series
Battery
2501.016 Battery 12.0V 1.8AH
Vacuum accessories Vacotron 460

3444.509 Vacuum electrodes Ø 30 mm, set of 2
3444.507 Vacuum lead hose, red
3444.508 Vacuum lead hose, black
Ordering information
For the ordering information of the 4-series, standard accessories and optional accessories we refer to
the website www.enraf-nonius.com.
Page 12 of 72 EN109-1498751-47 IFU

5 Installation
Inspection
In case of damage from transport is noticed, contact your local distributor.
DO NOT USE the device!
Immediately upon unpacking the device, perform the following steps:

• Verify the delivery documents to make sure that the delivery is complete.
• Verify that the packaging contains all the items listed in the standard accessories list.
• Check the external components and accessories for possible damage due to transport.
System without a Vacotron

• Remove the 4-series device and any additional items ordered from the carton and inspect for
damage that may have occurred during shipment.
• Place the device on a desk or EN-Car. Ensure that there is sufficient air flow below the device (do
not place the device on a table-cover).
• If required, place the unit on the supplied inclination foot to improve display legibility.
System with a Vacotron

• Remove the vacuum unit and any additional items ordered from the carton and inspect for
• Place the vacuum unit on a desk or EN-Car. Ensure that there is sufficient air flow below the device
(do not place the device on a table-cover).
• Remove the 4-series device and any additional items ordered from the carton and inspect for
• Place the main device on top of the vacuum unit.
• Carefully lift the main device at the front and insert flat cable [17] into connector [18].
Connection to mains supply

Use of any other cable other than the supplied cable is strictly PROHIBITED as it
affects patient safety and the proper function of the device.
Do not place the device in a location where the power cord could be tripped over or pulled
out during treatment!
Do not attempt to use the device if it is not properly grounded. Make certain that the device
is electrically grounded by connecting it only to a grounded electrical service receptacle
conformable with the applicable national and local electrical codes regarding medical
environments!
• Insert the mains cable into socket [1] and connect it to a wall socket.
• Set power line switch [1] to On (1)
• Power LED indicator [5] is lit green indicating that the device is connected to the mains supply.
• Turn on the device with push button [4]
• The device will initialize and perform a self-test. This may take a while.
• At the end of the self-test the device enters the Home menu and is ready for use.
Placing the optional battery

Do not interchange the black and red wires as this will damage your device!
The battery contains material that is noxious to the environment. Observe the local
regulations when disposing of the battery!
Due to the high current demand of ultrasound applications, we recommend to explicitly use
batteries supplied by Enraf-Nonius B.V. (part number 2501.016).
Page 13 of 72 EN109-1498751-47 IFU

• Remove the mains cable from the power line connector [1].
• Place the 4-series device upside down and on a soft surface.
• Remove the two screws from the battery cover using the supplied screwdriver.
• Slide and lift the battery cover.
• Align the battery on the bottom of the main unit with the polarity of battery terminals in the
correct position. The polarity is marked at the bottom of the battery compartment.
• Locate the black wire and attach it to the – terminal of the battery.
• Locate the red wire and attach it to the + terminal of the battery.
• Slide the battery upside down into the battery compartment taking care that the wires do not get
jammed.
• Place and slide the battery cover back into position.
• Secure the battery cover with the two screws using the supplied screwdriver.
• Place the device back on its feet.
• Reconnect the mains cable to the power line connector [1].
Operation from battery

• Leave power line switch [1] in the Off position (0) and turn on the device on using push button [4].
• Power LED indicator is lit orange, indicating that the device is operating from the battery.
• The charge status of the battery is indicated in the right hand top corner of the display.
• When you have finished the treatments, turn off the device using push button [4].
With the power line switch [1] to On (1), the battery is automatically charged, independent of the state
of the on/off push button [4]. We recommend to use the apparatus from the powerline whenever
possible. This will increase the service life of the battery.
Disconnection of mains supply

Systems without a battery
• When you have finished treatment, turn the device off by setting the power line switch [1] to Off
(0). The device is now disconnected from the mains supply.
Systems with a battery

• Turn off the device with push button [4].
• Power indicator LED [5] is still lit green, indicating that the device is still connected to the mains
supply and that the battery is being charged.
• Set power line switch [1] Off (0) to stop charging and to disconnect the unit from the mains
supply.
Page 14 of 72 EN109-1498751-47 IFU

6 Intended use and intended user
Ultrasound therapy
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.
Electrotherapy
Pain Management
Pain Management is the use of electrical stimulation for pain relief.
Muscle Stimulation
Muscle Stimulation is the use of electrical stimulation to treat muscle dysfunction.
Combination therapy
Combination therapy is the combined application of ultrasound and electrical stimulation. With
combination therapy the metal surface of the ultrasound treatment head 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.
Intended user
The 4-series device is intended to be used, and shall only be used, by or under the supervision of
professional users in the field of physical therapy and rehabilitation, who understand the benefits and
limitations of electrotherapy and ultrasound therapy.
Page 15 of 72 EN109-1498751-47 IFU

7 Indications
The 4-series can be used for the below mentioned symptoms or medical conditions.
Electrotherapy
Pain Management
• Symptomatic relief of chronic, intractable pain. Management of pain associated with post-
traumatic or postoperative conditions.
Muscle Stimulation
• 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
Ultrasound therapy
• 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.
Combination therapy
• Reduction of muscle spasm
Page 16 of 72 EN109-1498751-47 IFU

8 Contraindications
The 4-series MUST NOT be used for the below mentioned symptoms or medical conditions.
Electrotherapy
Pain management
• 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 trans cerebrally (through the head) must be avoided.
• Electrode placements that apply current trans thoracically (the introduction of electrical current
into the heart may cause cardiac arrhythmias) must be avoided.
Muscle stimulation
• 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 (*)
• Electrode placements that apply current trans cerebrally (through the head) must be avoided.
• Electrode placements that apply current trans thoracically (the introduction of electrical current
into the heart may cause cardiac arrhythmias) must be avoided.
Note (*) 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 therapy book "Dysphagia (by H.C.A.
Bogaardt SLP, PhD)"
Ultrasound therapy
• The established contra-indications 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 foetus
• The heart
• The brains
• The testicles
• The eyes
• Ultrasound should not be used on unconscious patients
*= Does not apply to LIPUS (Low Intensity Pulsed Ultrasound)
Page 17 of 72 EN109-1498751-47 IFU

Combination therapy
The combined Contra-indications of ultrasound therapy and electrotherapy apply.
Precautions and warnings

Ultrasound therapy
Precaution should be taken when using therapeutic ultrasound on patients with hemorrhagic
diathesis.
Ultrasound treatment presents a potential safety hazard in patients whose pain response has
been decreased because of disease, previous surgery, ionizing radiation therapy,
chemotherapy, general or regional anaesthesia. It may cause blisters. 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.
Always ensure proper hygiene (see chapter 14 for cleaning). Only apply the applicator on intact
skin. When treating damaged skin (for example ulcers), only place the applicator on the edges
of the wound, never on the wound itself.
Dual Channel Ultrasound is intended for a single patient only.
See also chapter 9 for general warnings and precautions.
Electrotherapy – Pain management

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.
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.
Electrotherapy – Muscle stimulation

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.
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
Page 18 of 72 EN109-1498751-47 IFU

conductive medium, or alternate electrode placement.
Combination therapy
Combination therapy is only allowed with a single ultrasound head connected.
Relevant hazards
Ultrasound therapy
• Use of ultrasound in treating areas above the shoulders may pose relevant hazards. While it is
recognized that certain specific conditions involving the eyes can and have been treated by
specialists qualified by training, knowledge and experience to administer such treatments, such
application carries with it recognized hazards of applying heat to the eyes.
• Treatment of the facial sinus exposes the eyes to the same hazards.
• Treatment of the thyroid, as well as lymph nodes in the neck, may expose the patient to as yet
undetermined effects, in as much as the safety of such treatments has not yet been established.
Potential adverse effects

Electrotherapy
When treated for Muscle Stimulation:
• Skin irritation and etching beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
When treated for Pain Management:
• Skin irritation and etching beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
Ultrasound therapy
• Cataracts
• Male sterility
• Enhanced drug activity
• Thermal stress
Combination Therapy
The combined adverse effects of ultrasound therapy and electro therapy apply.
Page 19 of 72 EN109-1498751-47 IFU

9 Precautionary instructions
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.
Keep yourself informed of the contra-indications.
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.
This device should be kept out of the reach of children.
This equipment is not suitable for use in the presence of flammable anesthetic mixture with air,
oxygen, or nitrous oxide.
Use of controls or adjustments or performance of procedures other than those specified herein
may result in hazardous exposure to ultrasonic energy.
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.
It is recommended that the 4-series should not be used after extreme temperature
fluctuations.
The device should not be used when any sort of mechanical damage is noticed.
Do not operate the unit in an environment of short-wave or micro-wave diathermy.
Caution!
Always determine the dosage based on the patient’s perception of heat. Any sensation greater
than mild warmth could cause a burn.
Do not operate the 4-series when connected to any unit other than Enraf-Nonius B.V. devices.
Do not use this device in so called “Wet Rooms” (hydrotherapy rooms).
This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F), with
a Relative Humidity ranging from 10 - 90 % (non-condensing).
Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive
amounts of dust, moisture, vibrations and mechanical shocks.
In the case of ingress of liquids, unplug the unit from the mains supply and have it checked by
an authorized person (see the paragraph on 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.
Handle ultrasound treatment head with care. Inappropriate handling of the ultrasound
treatment head may adversely affect its characteristics.
Inspect ultrasound treatment head for cracks and other mechanical defects which may allow
the ingress of conductive fluid before each use.
Page 20 of 72 EN109-1498751-47 IFU

10 General instructions
Ultrasound therapy
During treatment, the patient may not feel unpleasant sensations amounting to pain. A mild
sensation of excitation is permissible.
If, as result of treatment, headache, vertigo, fatigue and/or other (autonomic nervous)
reactions develop, subsequent treatment should be given at a lower intensity.
With continuous and pulsed ultrasound at high intensity a sensation of heat may be felt.
Only a mild sensation of warmth is acceptable.
Before treatment
Please make sure you have read and understood the content of this manual before you start
treatment.
Check the patient for any possible contra-indications.
Test the thermal sensitivity of the treatment area.
The skin of the area in question is cleaned (removal of grease) with soap or 70 % alcohol to permit
optimal transmission of the ultrasound.
Starting treatment
Position the treatment head (do not forget to apply gel on the patient).
When adequate contact is made, the timer will start.
When the contact between the treatment head and the patient is not adequate, LED ring (contact
control indicator) in the treatment head will turn on.
During treatment
The treatment head is kept in slow continuous motion, also for the semi-static method.
During treatment, the displayed ultrasound amplitude can vary around the set value, caused by
fluctuations in acoustical coupling. The patient is regularly asked to report any sensations felt. If
necessary, the treatment is modified;
The intensity can be reduced or a switch is made from continuous to pulsed ultrasound.
If there are indications of poor transfer of the ultrasound energy the contact medium can be reviewed
if necessary, add more contact gel or spread it with the ultrasound treatment head.
Important!
In order to ensure efficient transfer of energy, a contact medium is required between the treatment
head and the body. Air reflects virtually all of the ultrasound energy. The best medium for the transfer
of ultrasound energy is a gel.
• For preference, use Enraf-Nonius Contact-Gel®, as this allows the excellent characteristics of the
treatment heads to be used to their full advantage.
• The gel should be applied to the part of the body to be treated and then spread out with the
treatment head.
Ending treatment
Treatment can be stopped by taking off the treatment head from the patient and setting the timer to
zero. Treatment stops automatically when the treatment time has elapsed.
After treatment
The patient’s skin and the ultrasound treatment head are cleaned with a towel or tissue.
The ultrasound treatment head must be cleaned as described in chapter 14.
The expected effects are checked (e.g. pain, circulation, and mobility).
The patient is asked to comment subsequently on any reactions that may occur.
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Electrotherapy
During treatment, the patient may not feel unpleasant sensations amounting to pain. A mild
sensation of excitation is permissible.
If, as result of treatment, headache, vertigo, fatigue and/or other (autonomic nervous)
reactions develop, subsequent treatment should be given at a lower intensity.
Before treatment
Please make sure you have read and understood the content of this manual before you start
treatment.
The skin of the area in question is cleaned (removal of grease) with soap or 70 % alcohol. Shaving
hairy skin is recommended.
Test the sensitivity of the treatment area.
Position the electrodes and/or sponges (do not forget to moisten).
During treatment
Intensity is set at the desired level.
The patient is regularly asked to report any sensations felt. If necessary, the treatment is modified.
Ending treatment
Treatment can be stopped by pressing the stop icon on the touchscreen or setting the timer to zero.
Treatment stops automatically when the treatment time has elapsed.
After treatment
Remove the electrodes and/or sponges.
Clean the patient’s skin with a towel or tissue.
The expected effects are checked (e.g. pain, circulation, and mobility).
The patient is asked to comment subsequently on any reactions that may occur.
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11 Operation
Set up
Turn on the apparatus
Switch the unit ON via the push button [4].
The unit starts by executing the self-test.
At the end of the self-test a beep sound can be heard and the unit enters the Home menu and is
ready for use.
Display screen
The display is organized as a spreadsheet of 4 sheets, one for each channel. The channels refer to the
patient connector groups accessible at the front of the unit. A sheet can be selected by touching its
tab. The tab shows important information, such as the output amplitude and the remaining treatment
time. This information is continuously visible, also when the sheet is not selected.
[A] Device name.

[B] Navigation level. Shows where you reside in
the navigation.
[C] Battery indicator (only visible when operating
from the battery).
[D] Navigation bar. Provides screen dependent
buttons for several functions. See paragraph
Navigation Bar for details.
[E] Screen header. Shows the name of the screen,
such as Manual Operation or the name of the
selected Clinical Protocol.
[F] Parameters are indicated with icons. When a
parameter is selected, its name appears here.
[G] Screen body. Shows the parameters of a
selected channel or, when no channels are
selected, the menu buttons.
[H] Channel tab. Used to select a channel and to
display and adjust the output amplitude of
that channel. See paragraph Channel tab
information for details.
FIGURE 1
A selected sheet gives an overview of the parameters belonging to that channel. A parameter can be
selected by touching it, which causes its colour to be changed into white and the light ring around the
central controller [7] to be illuminated. The parameter can now be adjusted with the central controller
[7]. The parameter can be closed by touching it again or by touching another parameter.
To adjust the output amplitude of a channel, touch the tab of the selected channel again. Its colour
will change into orange. The output amplitude can now be adjusted with the central controller [7].
For some applications, such as interferential therapy and combination therapy, two adjacent channels
can be linked. Linked channels are indicated by a combined tab. The tab halves show the output
amplitude of each channel, while the parameters on the remainder of the sheet apply to both
channels.
When you turn on the unit, you will first enter the Home menu. In the Home menu, none of the
channels are selected. The Home menu provides a structured access to all therapies available within
the unit, with appropriate parameter defaults. Just select a menu item by touching the button to
Page 23 of 72 EN109-1498751-47 IFU

navigate to the next screen. You can navigate back to the previous screen by touching the back arrow
at the top of the screen. Anywhere in the navigation, you can jump back to the Home menu, by
touching the home button.
Navigation bar
The following buttons can appear in the navigation bar [D].
Button Meaning
Back, return to previous screen.
Home, return to Home screen.
Page number / number of pages in multi-page menu screens or treatment step

number / number of treatment steps in sequential protocols.
Store therapy settings or a programmed sequential protocol in a favorite.
Delete favorite.
Pause treatment. The output current decreases to 0 and the treatment timer
suspends counting down.
Start/Continue treatment. The output current increases to the previous value and the
treatment timer resumes counting down.
Accept the selected option.
Stops treatment on all channels simultaneously.
Channel tab information
[I] [J] [K]

Channel Tab Illustration
[L] [M]
[I] Output Indicator Standard electrodes
Vacuum electrodes
Ultrasound treatment head A
Ultrasound treatment head B
Combination Therapy
[J] Channel Status Channel stopped
Channel paused
Channel running
[K] Remaining treatment time. When a sequential protocol has been loaded, the value indicates
the total remaining treatment time of the sequential protocol.
[L] Output value
Page 24 of 72 EN109-1498751-47 IFU

[M] Unit of Output value: µA, mA, V, W, W/cm2
Adjusting current amplitude

To adjust the output current, touch the tab of the selected channel. Its colour will change to orange,
after which the current amplitude can be set with the central controller [7].
The current amplitude can only be adjusted when the clock has been set.
With 4 polar interferential current waveforms, the current amplitude operates on both channels
simultaneously. In this case, a balance facility is available for the classical interferential current
waveform (see paragraph Classical interferential for details).
The unity of the displayed current amplitude depends on the previously selected current waveform
and can be expressed in mA, µA or V.
A treatment is started by adjusting the current amplitude, unless a surge program has been selected.
To start a surge program, touch the Start/Continue button in the navigation bar.
CC/CV mode
Depending on the selected current waveform, the electrotherapy channels can be used in the
Constant Current (CC) or Constant Voltage (CV) 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.
Current polarity
When DC currents are used, the red connection is the positive connection and the black one the
negative connection.
Manually changing the polarity during a treatment will result in a current decaying to 0, followed by a
current with the opposite polarity, rising to a value equal to 80% of the previous value.
Surge programs
Surge programs allow you to program sequential increases and decreases in current amplitude. See
Figure 30 for details. Surge programs should not be confused with protocols:
• A single treatment step of a protocol could contain a surge program.
With independent channel operation, the surge programs run independently over both channels. They
can independently be enabled and their parameters can individually be set. When the current
channels are linked, the surge programs are also linked, which implies that their parameters have
identical values. In this case, a delay time can be set between the start of the surge on channel 1 and
channel 2.
A treatment with a Surge Program is started by first finding the desired current amplitude. During this
time, the system pauses. When the current amplitude has been established, the treatment can be
started by touching the Start/Continue button in the navigation bar.
Parameters:
See Figure 30 for details.
Ramp up time, expressed in seconds, defines the time in a surge program during which the current is
increased from 0 to the adjusted level. See Figure 30 for details. The Ramp up time can be adjusted in
increments of 0.1 second.
Hold time, expressed in seconds, defines the time in a surge program during which the current is kept
at the adjusted level. See Figure 30 for details. The hold time can be adjusted in increments of 1
second.
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Ramp down time, expressed in seconds, defines the time in a surge program during which the
current is decreased from the adjusted level to 0. See Figure 30 for details. The ramp down time can
be adjusted in increments of 0.1 second.
Interval time, expressed in s, defines the time in a surge program during which the current is kept at
0. See Figure 30 for details. The interval time can be adjusted in increments of 1 second.
Delay time, expressed in seconds, defines the time delay between the start of the surge program on
channel 1 and channel 2. See Figure 30 for details. The delay time can be adjusted in increments of 0.1
second.
Beep, if enabled, generates a short beep at the start of each surge.
Navigation
Electrotherapy
Home
The Home menu gives access to all functions of the unit. Select
the desired function or therapy by touching the button.
The next screen appears.
Electrotherapy “Clinical Protocols”
The electrotherapy menu gives access to functions

• Clinical Protocols
• Favorites
• Manual Operation
• Programming
Select Clinical Protocols by touching the button.

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Use the central controller to scroll through the list and select the
clinical protocol by touching the button.
The channel selection screen appears.
For therapy information touch the info button on the left side of
the protocol and the therapy info will appear.
Therapy information
Use the central controller to scroll through the pages, in most

cases the first page is text followed by one or more illustrations.
Touch the accept button ✓ in the navigation bar.
The channel selection screen appears.
Channel Selection
Here you can select the channels for electrotherapy.

When channel 1 is selected, channel 2 is still available for another
therapy.
When Channel 1+2 is selected both channels have the same
parameters. Only the intensity can be set differently.
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Parameter screen (therapy screen)
In this screen, the user can adjust the intensity or change the
parameter by touching the button and changing the value with
the central controller.
If there is a vacuum unit available the user can set the vacuum
settings direct from the menu.
Intensity setting
To set the intensity, touch sheet 1 (Channel 1).

Read-out change to orange colour and adjust with the central
controller.
Timer starts count-down.
Electrotherapy “Manual Operation”
The electrotherapy menu gives access to functions

• Favorites
• Programming
Select Manual Operation by touching the button.
Page 28 of 72 EN109-1498751-47 IFU

Select from the list a current waveform
Scroll to the next page with the central controller [7] or select
the current waveform by touching the button.
Note: some of these selections are groups and in the next

screen another list appears from which the current waveform
can be selected.
Channel Selection
Here you can select the channels for electrotherapy.

When channel 1 is selected, channel 2 is still available for
another therapy.
When Channel 1+2 is selected both channels have the same
parameters. Only the intensity can be set differently.
Parameter screen
Adjust the parameters by touching the button and change the

value with the central controller [7].
Note: some parameters are grouped and in the next screen the
settings can be changed the same way as above.
Page 29 of 72 EN109-1498751-47 IFU

Treatment time adjustment
Touch the timer button, the colour changes into white and
adjust the treatment time with the central controller [7].
Repeat this for all other parameters.
Start the therapy by adjusting the intensity with the central

controller [7].
• To pause the treatment, touch the pause button in the

navigation bar.
• To continue the treatment, touch the run button in the
navigation bar.
• To Stop the treatment, touch the STOP button in the
navigation bar.
Ultrasound Therapy
The Home menu gives access to all functions of the unit.
Select in the Home menu ultrasound therapy by touching the

button “Ultrasound Therapy”.
Page 30 of 72 EN109-1498751-47 IFU

Ultrasound Therapy “Clinical Protocols”
The Ultrasound Therapy menu gives access to functions

• Favorites
Select Clinical Protocols by touching the button.
Use the central controller to scroll through the list and select
the clinical protocol by touching the button.
For therapy information touch the info button left of the

protocol and the therapy info will appear.
Therapy information
Use the central controller [7] to scroll through the pages, in

most cases the first page is text followed by one or more
illustrations.
The parameter screen appears.
Page 31 of 72 EN109-1498751-47 IFU

The parameter screen appears.
Channel Selection
Here you can select the channels for Ultrasound.

When channel A is selected, channel B is still available for
another therapy. (Functionality may be limited if the dual
channel mode is not activated.)
The count-down starts when there is sufficient contact between

the applicator and the treatment surface.
Parameters can always be changed, before or during the
treatment.
Note: the light ring on the ultrasound treatment head will turn
off when sufficient contact is established.
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Combination Therapy
This therapy combines ultrasound and electrotherapy.
in the Home menu combination therapy by touching the button
“Combination Therapy”.
The Combination menu gives access to functions

• Favorites
Select Manual Operation by touching the button.
Select in this menu the current waveform by touching the

button.
Page 33 of 72 EN109-1498751-47 IFU

Channel Selection
Here you can select the channels for Ultrasound.
Note: A notification may appear if there are more than 1

Ultrasound treatment head connected. Follow the instructions
of the notification.
Adjust the current parameters and treatment time

• Touch the parameter button and adjust with the central
controller [7].
Page 34 of 72 EN109-1498751-47 IFU

• Select the ultrasound button to adjust the ultrasound
parameters.
• Touch the electrotherapy button to return to the previous
electrotherapy screen.
• Touch the ultrasound read-out and adjust the intensity

with the central controller [7].
• Touch the current read-out channel 2 to adjust the
current intensity. (Electrode and treatment head need to
be in contact with the patient when in CC mode.)
Vacuum
If a unit is equipped with a Vacotron it’s possible to select either

rubber electrodes or vacuum cups.
• Touch the – button and adjust the pressure using the
central controller [7]. The vacuum cups are automatically
selected when the pump starts to run.
Page 35 of 72 EN109-1498751-47 IFU

Continuous – Pulsed mode
• Touch the – button and select the desired massage
rhythm using the central controller [7]. You can choose
between Continuous, Pulsed mode 1 s and Pulsed mode
2 s.
Storing Favorites
When a treatment screen is completely set as required, its

settings can be stored in a Favorite for later use:
• As long as the treatment has not been started, a Store
button is available on the navigation bar. To store your
settings, touch the Store button in the Navigation bar.
• Enter the name of your Favorite using the keyboard.

• Touch ✓ to store your Favorite under the name just
entered.
Note:
• Once saved, Favorites can be retrieved from the

Electrotherapy, Ultrasound Therapy, and Combination
Therapy menus.
• 4-polar treatments are automatically saved and loaded as
a dual channel treatment.
• Vacuum settings are not saved.
• Stored Favorites can be sorted alphabetically (via the
System Settings menu).
Page 36 of 72 EN109-1498751-47 IFU

Programming a Sequential Protocol
A sequential protocol consists of a series of treatment steps

that are executed in a sequence until the end of the protocol is
reached.
• Select Programming in the electrotherapy menu.
• When a treatment screen is completely set as required,

touch the “next” button to add a next step.
• Continue with the remaining treatment steps until you
have reached the end of your protocol.
• Touch the Store button in the navigation bar.
• Enter the name of your sequential protocol as described
in paragraph Storing Favorites.
Sequential protocols are stored under the Favorite menu.
System Settings
in the Home Menu System Settings by touching the button
“System Settings”.
Page 37 of 72 EN109-1498751-47 IFU

In this screen, you can personalize the unit. Several settings can
be changed or adjusted. Touch the Back arrow in the
navigation bar to return to the Home menu.
• Language, touch the language button and select the
desired language using the central controller [7]. Touch
the language button again or touch another button to
confirm.
• LCD Brightness, here you can change the intensity of the
backlight of the screen.
• Speaker volume can be adjusted in 5 levels.
• Energy Saver after, allows the user to select the duration
until energy saving activities are enabled.
• End of Treatment – Sound, allows the user to select 5
different type of EOT sound each with 4 additional signal
beeps.
• Sort Favorites, when enabled will automatically sort the

Favorites alphabetically.
• Ultrasound Standard, determines the ERA calculation
model (USA or IEC).
• System Info, the current installed system version
• Notifications, sub-menu where various notifications can
be changed.
• Maintenance, sub-menu where maintenance routines can
be accessed.
Shut down the device

Turn off the device as described in “Disconnection of mains supply”.
Page 38 of 72 EN109-1498751-47 IFU

12 Application information
Before starting the treatment please make sure:
You have read and understood the content of this manual.
You strictly follow the WARNINGS and CAUTIONS mentioned under precautionary instructions.
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.
Electrotherapy
Do not use electrodes on open wounds.
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. Preferred is to use a saline solution
instead because of the improved 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 good
in poor electrical conductivity. 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 (close to dripping when lightly squeezed) during treatment,
especially with DC currents. Remoisten when treatment exceeds 10 minutes. If the current display
starts blinking, it is an indication of poor electrical contact.
• After use clean the sponge pads as described under “cleaning and disinfection”.
Page 39 of 72 EN109-1498751-47 IFU

Vacuum electrodes
There is a choice of large and small electrodes. The areas of the electrodes correspond to those of the
4 x 6 cm and 6 x 8 cm 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 (close to dripping when lightly squeezed) during treatment.
Remoisten when treatment exceeds 10 minutes. After use clean the sponge pads as described under
Cleaning and Disinfection.
Self-adhesive electrodes
Self-adhesive electrodes have higher series impedance than flexible rubber electrodes. This can cause
the stimulator to terminate treatment at higher current amplitudes. When this occurs, it is
recommended to continue the treatment with flexible rubber electrodes, combined with properly
moistened sponge pads.
Self-adhesive electrodes are not recommended for use with currents that contain a DC component.
Ultrasound therapy
Contact control
The ultrasound head has a contact control function that suspends treatment when the acoustical
contact with the body drops below a certain level. The indicator light on the ultrasound head is turned
on to signal this situation, the ultrasound channel status icon changes to pause and the treatment is
resumed at the set Amplitude.
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 ultrasound head only partially contacts the body. When contact
restoration is sensed the treatment is resumed at the set Amplitude.
Note: The contact control function does not work at Amplitudes below 0.2 W/cm².
The contact medium

Never apply the gel directly 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.
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.
Vacuum
Vacuum electrodes make good contact with the skin, which means that effective use is made of the
whole electrode area. The massage effect resulting from the pulsed vacuum ensures a good blood
flow through the skin under the electrodes. This reduces the resistance of the skin and increases he
effectiveness of the stimulation current.
Page 40 of 72 EN109-1498751-47 IFU

• See paragraph Vacuum electrodes for the application of the vacuum electrodes.
• When you use only one vacuum channel, close the other channel with one of the vacuum cables
not in use.
Electrolytic effects
Electrolysis occurs under the electrodes when current types with a DC component are applied.
Because the largest concentration of electrolytic by-products caused by ion migration occur under the
electrodes, we recommend the use of the supplied sponges to keep the effects to a minimum. Make
sure that the sponges are kept well moistened and place the thick side of the sponge between the
flexible rubber electrode and the patient.
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
etching 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:
𝐼𝑅𝑀𝑆 = 𝐼𝑝𝑒𝑎𝑘 √𝑝ℎ𝑎𝑠𝑒 𝑑𝑢𝑟𝑎𝑡𝑖𝑜𝑛 [µ𝑠] ∗ 𝑝𝑢𝑙𝑠𝑒 𝑓𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦 [𝐻𝑧] ∗ 106
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.
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.
Page 41 of 72 EN109-1498751-47 IFU

13 Description – Current waveforms and Ultrasound parameters
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, of which the following are available in the 4-series:
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 obtain the 100% modulation depth (fig 2). The current balance can also be
used to compensate for differences in sensation occurring under the electrodes.
FIGURE 2
Modulation depth is only 100% at the diagonals.
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.
FIGURE 3
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.
Page 42 of 72 EN109-1498751-47 IFU

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%.
FIGURE 4
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.
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.
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 (figure 26-28).
• 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 seconds, defines the time elapsed during one revolution of the
vector in automatic dipole vector mode.
Biphasic pulsed currents (TENS)

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 figure 6 for a graphical representation.
Page 43 of 72 EN109-1498751-47 IFU

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 (figure 7). 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 (figure
26-28).
Parameters:
• Phase duration, expressed in microseconds (µs), is the elapsed time from the beginning to the
end of the initial pulse phase.
• Pulse frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses.
• 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
• Modulation program, defines the time and sequence in which the frequency will sweep through
the Frequency modulation range.
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. 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 last 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 microseconds (µs), is the elapsed time from the beginning to the
• Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the
TENS pulses.
• Burst Frequency, expressed in Hz, defines the repetition rate of bursts of pulses. A burst consists
of a train of pulses. Each burst last 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.
Symmetrical
TENS current pulses can also be used for muscle stimulation applications. Often the symmetrical
biphasic pulsed current waveform is used. 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:
end of a pulse phase. The phase duration applies to each pulse phase.
TENS pulses.
• 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
• Modulation Program defines the time and sequence in which the frequency will sweep through
Page 44 of 72 EN109-1498751-47 IFU

• Surge Program can be used to adjust repeated sequences of contraction and rest periods.
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 Figure 12 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 last 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:
TENS pulses.
• Burst Frequency, expressed in Hz, defines the repetition rate of bursts of pulses. A burst consists
of a train of pulses. Each burst last 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.
Premodulated
As with Interferential currents, a medium carrier frequency is used to pass the low frequency
stimulation (beat) frequency through the skin. ‘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
the Frequency modulation range. See for the available Modulation programs.
Russian stimulation
This current type is an intermittent alternating current with a carrier frequency around 2500 Hz. See
Figure 6 for the current waveform. Russian Stimulation was first used by Kots, a lecturer in sports
medicine at the Moscow State Academy. 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 largest contraction, while the optimum frequency in indirect
stimulation was 1000 Hz.
Page 45 of 72 EN109-1498751-47 IFU

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 20 ms, 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 kHz, is the base frequency of the alternating current.
• 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 = 3.3
ms and the interval duration will be 20 * 5/6 = 16.7 ms.
Micro current
Micro Current is a monophasic rectangular waveform with manually selectable or alternating polarity.
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 per second.
• Alternation mode defines whether the polarity of the wave is automatically alternating or not.
• Alternation Period, 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. Surge
programs are only available in the non-alternating mode.
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:
twin pulses.
Page 46 of 72 EN109-1498751-47 IFU

• 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.
• Alternation Mode defines whether the polarity of the pulses is automatically alternating or not.
• Alternation Period, expressed in seconds, defines the polarity reversal time in the alternating
mode.
programs are only available in the non-alternating mode.
Diadynamic currents
Diadynamic currents are monophasic currents that produce electrolysis by-products. These by-
products can result in etching beneath the electrodes. Always use properly moistened sponge /
electrode combinations to absorb these by-products during treatment.
The Diadynamic currents were introduced by Bernard (*) and have won a significant position in the
history of European physiotherapy. 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.
(*) Bernard, Pierre D. La thérapie diadynamique, Paris, Editions ‘Physio’, 1962.
The following variations are available:
MF (Monophasé Fixe)
MF is a single phase rectified sinusoidal current with a frequency of 50 Hz. MF is a vibrating waveform
that easily induces contractions.
DF (Diphasé Fixe)
DF is a dual phase rectified sinusoidal current with a frequency of 100 Hz. DF is usually experienced as
a slight vibration. It is a pleasant waveform that is often used as an introduction to CP or LP.
LP (Longues Périodes)
LP is a slow alternation between six seconds of MF current and a six-second DF current. In the DF
phase the intervals between the MF pulses are filled with additional pulses with gradually increasing
and decreasing amplitude. LP is smoother than CP.
CP (Courtes Périodes)
CP is a rapid alternation between one second of MF current and one second of DF current. CP has a
strong resorbing effect.
CPid
CPid is identical to CP, except that the current amplitude during the MF phase is 12.5% lower than
during the DF phase. Normally a lower frequency is experienced to be more aggressive than a higher
frequency. CPid prevents this difference in sensation.
Page 47 of 72 EN109-1498751-47 IFU

Parameters:
programs are only available with MF and DF.
Galvanic current
Continuous galvanic current
The Direct Galvanic Current is a monophasic current that produces electrolysis by-products.
These by-products can result in etching beneath the electrodes. Always use properly
moistened sponge / electrode combinations to absorb these by-products during treatment.
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.
Interrupted galvanic current

The MF interrupted galvanic current is a monophasic current that produces electrolysis by-
products. These by-products can result in etching beneath the electrodes. Always use properly
moistened sponge / electrode combinations to absorb these by-products during treatment.
The medium frequency interrupted galvanic current is a monophasic rectangular waveform with a
pulse frequency of 8000 Hz and a duty cycle of 90%. As opposed to direct galvanic current, the pulsed
waveform provides increased patient comfort.
Faradic current
Faradic rectangular or triangular pulsed current
Faradic currents are monophasic currents that produce electrolysis by-products. These by-
Faradic currents are often used for muscle stimulation applications that are based on prior diagnostics.
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
1000 milliseconds) 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.
Parameters:
• Phase Duration, expressed in milliseconds or seconds, is the elapsed time from the beginning to
the end of the pulse phase.
current pulses.
Page 48 of 72 EN109-1498751-47 IFU

Träbert, 2 – 5 Current
Faradic currents are monophasic currents that produce electrolysis by-products. These by-
The 2-5 or ‘Ultra-Reiz’ current was introduced by Träbert (*). 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 2
milliseconds and a phase interval of 5 milliseconds. These settings are the default settings for the
faradic rectangular current waveform and result in a pulse frequency of approximately 143 Hz. Träbert
offered no explanation for the choice of these parameters. Nevertheless, many specialists have
adopted the therapy and it is still applied with success.
(*) Träbert, H. Ultra-Reizstrom, ein neues therapeutisches Phänomen, Elektromedizin 2, 1957 (7).
Parameters:
• Phase Duration, expressed in milliseconds or seconds, is the elapsed time from the beginning to
the end of the pulse phase. The default setting is 2 milliseconds.
• Phase Interval, expressed in milliseconds or seconds, is the elapsed time between successive
pulse phases. The default setting is 5 milliseconds.
Illustrations current waveforms

Premodulated / isoplanar vector / dipole vector FIGURE 5
fc Carrier frequency
fb Beat frequency
Russian stimulation FIGURE 6 
fc Carrier frequency
fB Burst frequency




Page 49 of 72 EN109-1498751-47 IFU

Biphasic pulsed current TENS
Asymmetrical FIGURE 7 
t Phase duration
fp Pulse frequency


Asymmetrical alternating FIGURE 8 

t Phase duration
fp Pulse frequency



Burst asymmetrical FIGURE 9 

fB Burst frequency

Burst asymmetrical alternating FIGURE 10
fB Burst frequency

Symmetrical FIGURE 11 

t Phase duration
ti Phase interval
fp Pulse frequency

Page 50 of 72 EN109-1498751-47 IFU

Burst symmetrical FIGURE 12 
fB Burst frequency






Faradic Current
Träbert, 2 – 5 current FIGURE 13 
tp Phase duration: 2 ms
ti Phase interval: 5 ms

Rectangular pulsed current (ms) FIGURE 14 
tp Phase duration
ti Phase interval
Rectangular pulsed current (Hz) FIGURE 15
tp Phase duration
fp Pulse frequency
Page 51 of 72 EN109-1498751-47 IFU

Triangular pulsed current (ms) FIGURE 16
tp Phase duration
ti Phase interval
Triangular pulsed current (Hz) FIGURE 17
tp Phase duration
fp Pulse frequency
Galvanic current
Galvanic interrupted FIGURE 18
f Carrier frequency - 8 kHz fixed
Duty cycle - 90 % fixed


Galvanic continuous FIGURE 19
High voltage FIGURE 20


t Peak interval - 64 µs fixed
fp Pulse frequency

Micro current FIGURE 21
f Frequency
Page 52 of 72 EN109-1498751-47 IFU

Diadynamic current
MF
FIGURE 22
DF
FIGURE 23
LP
FIGURE 24
CP
FIGURE 25
CPid
FIGURE 26
Modulation program
Modulation program 1/1 FIGURE 27
fp Pulse frequency 
fm Frequency modulation 
Page 53 of 72 EN109-1498751-47 IFU

Modulation program 6/6 or 12/12 FIGURE 28
6:6 or 12:12
fm Frequency modulation
Modulation program 1/30 FIGURE 29
1:30
fm Frequency modulation 
Surge program
Surge program parameters FIGURE 30
tr Ramp up time 
th Hold time
tf Ramp down time
ti Interval time
td Delay time 
Page 54 of 72 EN109-1498751-47 IFU

Current waveforms – Pain management
For pain management, the following current waveforms are recommended.
• 4-Polar Interferential Currents
• Biphasic Pulsed Currents (TENS)
• Premodulated
• Micro Current
• High Voltage
• Diadynamic Currents
• Galvanic Current
• Träbert, 2 – 5 Current
Current waveforms – Muscle stimulation

For muscle stimulation, the following current waveforms are recommended.
• Biphasic Pulsed Currents (TENS)
- Asymmetrical and Alternating asymmetrical
- Symmetrical
• Premodulated
• Russian Stimulation
• High Voltage
• Faradic Current
- Faradic Rectangular or Triangular pulsed current
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.
Current waveforms – Combination therapy

Combination therapy is available with all current waveforms, but limited to channel 2.
Page 55 of 72 EN109-1498751-47 IFU

Stimulator output parameters
Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV), except for
High Voltage (CV) and Microcurrent (CC).
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.2 mA
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, in steps of 1s
Hold time : 0 – 60 s, in steps of 1 second
Ramp down time : 0 – 9 s, in steps of 1s
Interval time : 0 – 120 s, in steps of 1 second
Delay time : 0.1 – 80 s, below 10s in steps of 0.1s, otherwise in steps of 1s
Interferential, 4 polar
Carrier Frequency : 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10 kHz
Beat Frequency (AMF) : 0 – 200 Hz in steps of 1 Hz
Frequency Modulation (spectrum) : 0 – 180 Hz in steps of 1 Hz
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Amplitude : 0 – 100 mA
Isoplanar vector
Modulation program : 1/1, 6/6, 12/12, 1/30/1/30 s
Dipole Vector Automatic

Rotation time : 1 – 10 s in steps of 1 s
Dipole Vector Manual

Modulation Program : 1/1, 6/6, 12/12, 1/30/1/30 s
Resolution vector : 2.25° per step (160 steps over 360°)
Asymmetrical
Phase Duration : 10 – 400 µs in steps of 5 µs
Page 56 of 72 EN109-1498751-47 IFU

Pulse Frequency : 1 – 200 Hz, in steps of 1 Hz
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Surge Program : Yes
Amplitude : 0 - 140 mA
Asymmetrical Alternating
Frequency Modulation : 0 – 180 Hz, in steps of 1 Hz
Surge Program : Yes
Burst Asymmetrical
Burst Frequency : 1 – 9 Hz, in steps of 1 Hz
Burst Asymmetrical Alternating

Symmetrical
Surge Program : Yes
Burst Symmetrical
Premodulated
Beat Frequency : 0 – 200 Hz in steps of 1 Hz
Surge Program : Yes
Russian Stimulation
Burst Frequency : 0 – 100 Hz in steps of 1 Hz
Page 57 of 72 EN109-1498751-47 IFU

Burst / Pause : 1:1, 1:2, 1:3, 1:4, 1:5
Surge Program : Yes
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 cannot exceed 200 Hz
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 cannot exceed 200 Hz
Alternating Period : 10 – 100 seconds in steps of 10 s
Ramp up, ramp down : 0.5 seconds
Amplitude : 0 – 500 Volt in steps of 1 Volt
Micro Current
Frequency : 0 – 1000 Hz
Surge Program : Yes
Amplitude : 10 µA – 1 mA in steps of 10 µA
Micro Current Alternating

Frequency : 0 – 1000 Hz, 0 – 100 Hz in steps of 0.1 Hz, 10 – 100 Hz in steps
of 1 Hz, 100 – 1000 Hz in steps of 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 up, ramp down : 0 seconds
Amplitude : 10 µA – 1 mA in steps of 10 µA
Diadynamic current
Settings : MF, DF, CP, LP and CPid
Surge Program : on MF and DF
MF interrupted galvanic current

Frequency : 8000 Hz
Duty cycle : 95%
Direct Galvanic current

Page 58 of 72 EN109-1498751-47 IFU

Faradic Rectangular Pulsed Current (ms)
Phase Duration : 0.02 – 1000 ms
Phase Interval : 5 – 50 ms in steps of 5 ms, 50 – 100 in steps of 10 ms, 100 –
1000 ms in steps of 100 ms, 1 – 5 seconds in steps of 1 second
Surge Program : Yes
Faradic Triangular Pulsed Current (ms)

Phase Interval : 5 – 50 ms in steps of 5 ms, 50 – 100 in steps of 10 ms, 100 –
1000 ms in steps of 100 ms, 1 – 5 seconds in steps of 1 second
Surge program : Yes
Faradic Rectangular Pulsed Current (Hz)

Pulse Frequency : 0.2 – 1 Hz in steps of 0.1 Hz, 1 – 200 in steps of 1 Hz
Surge Program : Yes
Faradic Triangular Pulsed Current (Hz)

Pulse Frequency : 0.2 – 1 Hz in steps of 0.1 Hz, 1 – 200 in steps of 1 Hz
Surge program : Yes
Träbert 2-5 (Rectangular Pulsed Current)

Phase Duration : 2 ms
Interval : 5 ms
Page 59 of 72 EN109-1498751-47 IFU

Ultrasound 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 by the Duty Cycle.
Continuous ultrasound Explanation of symbols:
f Ultrasonic radiation with an

acoustic working frequency of 1
or 3 MHz
fp Pulse repetition rate
dc Duty cycle
t Pulse duration
Pulsed ultrasound Ultrasound parameters:
f Acoustic working frequency: 1MHz or

3MHz
fp Pulse repetition rate: 16, 48 and 100 Hz
dc Duty cycle: 5 – 80 %
t Pulse duration: 0.5 – 8 ms, set by duty

cycle
RTPA 20 – 1.25
Page 60 of 72 EN109-1498751-47 IFU

Amplitude Duty cycle Pulse RTPA Amplitude Duty cycle Pulse RTPA
modulation duration modulation duration
16Hz 5% 3.1ms 20 48Hz 50% 10.4ms 2
16Hz 10% 6.3ms 10 48Hz 80% 16.7ms 1.25
16Hz 20% 12.5ms 5 48Hz 100%* 20.8ms 1
16Hz 33% 20.6ms 3 100Hz 5% 0.5ms 20
16Hz 50% 31.3ms 2 100Hz 10% 1ms 10
16Hz 80% 50ms 1.25 100Hz 20% 2ms 5
16Hz 100%* 62.5ms 1 100Hz 33% 3.3ms 3.33
48Hz 5% 1ms 20 100Hz 50% 5ms 2
48Hz 10% 2.1ms 10 100Hz 80% 8ms 1.25
48Hz 20% 4.2ms 5 100Hz 100%* 10ms 1
48Hz 33% 6.9ms 3.33
* = continuous mode
Generator
Peak output Amplitude:
Duty cycle 5 – 50 % : 0 – 3 W/cm²
Duty cycle 80 % : 0 – 2.5 W/cm²
Duty cycle 100 % : 0 – 2 W/cm² (continuous wave)
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 : 16, 48 and 100 Hz ± 1 %

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 ± 5 %
3 MHz : 3.1 MHz ± 5 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm2
21 CFR 1050.10 : 5 cm2
Page 61 of 72 EN109-1498751-47 IFU

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 ± 5 %
3 MHz : 3.1 MHz ± 5 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 0.6 cm2
21 CFR 1050.10 : 0.8 cm2
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 area

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 to 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 can be set
under System Settings and depends on the ultrasound standard used:
• International: IEC 60601-2-5:2000
• USA: 21 CFR 1050.10
The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.
Page 62 of 72 EN109-1498751-47 IFU

14 Maintenance and troubleshooting
Cleaning and disinfection
Before performing any user maintenance, switch off the device and disconnect the plug from
the mains supply.
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.
Use no liquid detergents, these can damage the device.
Do not allow any liquids to penetrate the device or its accessories while cleaning and
disinfecting!
Dry all sockets and connectors that have become wet before any further use!
Check the applicator and cable regularly for damage.
Device To clean the unit, turn it off and unplug the power supply. Clean the unit with a
damp cloth. Do not use abrasive cleaners.
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
then carefully clean the panel.
Ultrasound To prevent corrosion, clean and dry the contact surface immediately after use.
applicator 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.
Electrodes and Between patient uses, the rubber electrodes should be cleaned with lukewarm
accessories water. To disinfect the electrodes or to remove stubborn stains of dirt, use a
70% alcohol solution. The alcohol solution can cause the black colour to be
stained, but this does not affect the operation of the electrodes.
Between patient uses, the sponge pads should be washed in running tap
water, thoroughly drained, and then dried. Damaged sponge pads should be
replaced.
Patient cable Clean the patient cable with a damp cloth. 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.
Vacuum The vacuum electrodes and sponges should be cleaned with lukewarm water.
electrodes and In the case of persistent dirt, and for disinfection, a 70% alcohol solution may
sponges 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.
Vacuum cables Clean the vacuum cable with a damp cloth. Do not use an alcohol solution.
Check the cable regularly for damages and/or bad electrical contact. We
advise, keeping a spare vacuum cable in stock.
Page 63 of 72 EN109-1498751-47 IFU

Cleaning the • Detach the vacuum cups from the vacuum cables.
water reservoir • Place a container filled with a cleaning liquid (*) below the system.
and hoses • Place the peripheral ends of the cables in the container.
• Go to System Settings and select Tank Cleaning.
• The water reservoir will be filled with the cleaning liquid until the water
reservoir is full.
• Empty the water reservoir as described below (water reservoir full).
(*) 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%.
Troubleshooting
When the device 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.
Errors and warnings indicate an internal problem with the device that must be tested by a field
service technician certified by Enraf-Nonius B.V. before any further operation or use of the
system. Use of a device that indicates an error or warning may pose a risk of injury to the
patient, user, or extensive internal damage to the system. In case of display failure or other
obvious defects, unplug the device immediately and notify a certified service technician.
Patient circuit interrupted

There is insufficient or no output current available at the outputs. Possible causes:
• 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 solved.
If none of the above scenarios appear to be the problem, stop using the device and contact your
supplier.
Battery low
The battery is insufficiently charged to complete the treatment at the currently set therapy levels.
Reduce the therapy levels or connect the apparatus to the mains supply.
Water reservoir full

The water separation tank of the Vacotron is full. Continue the treatment with the standard electrodes
or empty the tank as follows:
• Set power line switch [1] Off (0).
• Detach the hose from the upper hose nipple [15] and empty the reservoir.
• Reattach the hose to the hose nipple.
• Set power line switch [1] On (1).
Page 64 of 72 EN109-1498751-47 IFU

Vacuum leak
There probably is a leak in the vacuum system. This error is usually preceded by a continuously
running pump trying to reach the set vacuum. To protect the system, the pump is automatically
stopped after a certain amount of time. Inspect the vacuum cables and electrodes, set the vacuum
back to zero and try again. If the failure persists, stop using the device and contact your supplier.
Ultrasound applicator error

The ultrasound applicator has reported an error. Disconnect the device, wait some time and reconnect
it. If the error persists, stop using the device and contact your supplier.
Insufficient DC supply
This problem can sometimes occur with the small ultrasound applicator when operating from the
battery. If possible, continue the treatment with reduced therapy levels or connect the apparatus to
the mains supply.
Device needs to cool down before you can proceed

The temperature of the device is too high to start treatment. Remove the device from any potential
heat sources (such as direct sunlight) and let the device cool down. Restart the device to continue.
Possible risk of skin irritation

This notification is shown when operating a waveform that contains a DC component. Operator
should proceed with caution.
The intensity you have set is above the recommended maximum

When increasing the dosage of a StatUS device above the recommended maximum of 1.5W/cm 2 this
notification is shown. Operator should proceed with caution.
StatUS applicator error

The StatUS applicator has reported an error. Disconnect the device, wait some time and reconnect it. If
the error persists, stop using the device and contact your supplier.
The modulation is OFF. Higher risk of cavitation and/or hotspots

This notification is shown when operating a StatUS with modulations turned off. Turning off the
modulation increases the risk of cavitation and / or hotspots. Operator should proceed with caution.
Battery empty. Use power cord

The battery has been completely drained and operation of the device is disabled. Please connect the
power cord and charge the battery. Restart the device when connected to mains power to continue
operation.
Combination Therapy is only allowed with one US head connected

The notification will be shown when there is more than 1 ultrasound head connected to the device.
Combination therapy is only allowed with a single ultrasound head connected. Disconnect the inactive
ultrasound head to continue.
Combination therapy is not allowed with StatUS

The notification will be shown when there is a StatUS applicator connected to the device. Combination
therapy is not allowed with a StatUS applicator connected. Disconnect the StatUS applicator to
continue.
Page 65 of 72 EN109-1498751-47 IFU

Intended use of dual channel ultrasound therapy is for one patient only
This notification is shown when activating the Dual Channel functionality of the device. The purpose is
to remind the operator that the intended us of Dual Channel Ultrasound is for a single patient only.
Favorite is in use on a channel. Please restart the device and try again
This notification is shown when trying to delete a favorite that is currently loaded on one of the
channels. Restart the device to clear the loaded favorite or load a different waveform on the blocking
channel.
Permitted channels are in use, to free up channel stop active treatment

This notification is shown when trying to use a therapy when all the available channels are already in
use. Stop the active treatment by pressing the STOP icon or set the Timer to 0:00 on the blocking
channel.
Connected applicator(s) incompatible with chosen therapy. Please connect compatible

applicator
This notification is shown when trying to use a therapy when an incompatible applicator is connected.
Please disconnect and connect a suitable connector and try again.
Firmware update are not allowed when running on battery. Please connect to mains power
This notification is shown when trying to use upgrade the Firmware of the device while operating on
battery power. Firmware upgrades are only allowed when operating on mains power.
Maintenance
Optimize contact control ultrasound applicator
When you experience difficulties with the contact control function of the ultrasound applicator you
can try to resolve the problem as follows:
• Ensure that the surface of the ultrasound applicator is clean and dry.
• Place the ultrasound treatment head in the holder.
• Go to System Settings -> Maintenance and select Optimize Applicator A or B.
• Touch the OK-button when the operation is complete.
Back-up and restore favourites

When you have programmed and stored several Favorites, you might want to make a back-up on an
external storage device. To store your favorites, proceed as follows:
• Attach a USB-stick to the remote-control connection [3]. Read and obey the warnings and
cautions.
• Go to Systems Settings -> Maintenance and select Back-up Favorites.
• If an error occurs during the back-up operation, i.e. USB-stick full, this will be displayed in a pop-
up message.
• Detach the USB-stick
To restore your favorites

• Attach the USB-stick containing your Favorites to the remote-control connection [3]. Read and
obey the warnings and cautions.
• Go to Systems Settings -> Maintenance and select Restore Favorites.
• If an error occurs during the restore operation, i.e. no favorites found, this will be displayed in a
pop-up message.
Page 66 of 72 EN109-1498751-47 IFU

Technical maintenance
Electrical safety of the device relies on a properly earthed electrical connection via the power
cord. It is therefore necessary to have this connection checked annually.
To ensure continued compliance with the 21 CFR 1050.10 standard, this unit should be
adjusted and safety tested once each year. Procedures laid down in the service manual should
be followed. This may be carried out by your supplier, or by another agency, authorized by
the manufacturer. It is also recommended that a service history record is maintained. In some
countries this is even obligatory.
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
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.
On request a service manual can be made available containing: spare part list, descriptions, calibration
instructions and other information which will assist the user’s qualified technical personnel to repair
those parts of the equipment which are designated by the manufacturer as repairable.
All other technical maintenance is restricted to authorized Enraf-Nonius maintenance personnel.

Authorized service personnel can make use of 1498.770 Service manual 4-series.
Firmware update
If your system requires a Firmware Update, contact your supplier to obtain a USB-stick containing the
latest firmware version. Your current firmware version can be viewed under System Settings. To
update your firmware, proceed as follows:
• Attach the USB-stick containing the firmware to the remote-control connection [3]. Read and
obey the warnings and cautions.
• Go to Systems Settings -> Maintenance and select Update Firmware.
• If an error occurs during the update operation, i.e. no firmware found, this will be displayed in a
pop-up message.
Expected service lifetime

This device will remain suitable for its intended use as long as it is subjected to yearly maintenance by
a qualified service engineer as described in the service manual.
The service engineer will decide whether the device is suitable for use according to the specifications.
End of life
Your 4-series contains materials which can be recycled and/or are noxious for the environment.
Please ensure that you are well informed of the local rules and regulations regarding
the removal of equipment and accessories.
Page 67 of 72 EN109-1498751-47 IFU

15 Specifications
Technical data
Mains voltage: 100 - 240 Volt
Frequency: 50/60 Hz
Max. power input: 100 VA
Patient leakage current: typically, 1 μA
idem single fault condition: typically, 2 μA
Main Unit
Dimensions stand alone 24 x 32 x 12 cm (w x d x h)
Dimensions on inclination foot 24 x 30.5 x 18.2 cm (w x d x h)
Dimensions on Vacotron 24 x 30.5 x 21.6 cm (w x d x h)
Weight 2 kg
Weight including optional battery 3 kg
Vacotron
Dimensions 24 x 28.6 x 9.3 cm (w x d x h)
Weight 2 kg
Vacuum continuous and pulsed,
0 – 800 mbar, continuously adjustable
Pulsed Vacuum pulse : pause = 0.5 : 0.5 seconds, 1 : 1 second
Technical modifications reserved
Safety and performance standards

Medical device classification IIa; Rule 9 Annex IX of 93/42/EEC
This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).
IEC 60601-1 General requirements for the safety of electrical medical
systems, including Annex I, national differences for
Australia, Canada, and the United States.
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.
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.
Safety class according to IEC 60601-1 I
Applied parts
Type B applied part (ultrasound applicator)
Type BF applied part (electrodes)
Page 68 of 72 EN109-1498751-47 IFU

Environmental conditions
Environmental conditions for transport and storage
Environmental temperature: –20° to +70° C
Relative humidity: 10 to 90% (non-condensing)
Atmospheric pressure: 500 to 1060 hPa
Environmental conditions normal use

Environmental temperature: 10° to 40° C
Relative humidity: 10 to 90 % (non-condensing)
Atmospheric pressure: 500 to 1060 hPa
EMC details
Medical electrical devices such as the 4-series are subject to special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and commissioned in accordance
with the EMC advice given in the instructions for use.
Portable and mobile RF communication systems (e.g. mobile phones) may interfere with
medical electrical devices.
The 4-series should only be operated with the original power cable specified in the list of
contents delivered. Operating the device with any other power cable can lead to increased
emissions or reduced interference immunity of the device.
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
The main features of the 4-series devices are as follows: interference-free delivery of shockwaves,
interference-free control of all functions. Uninterrupted operation is not required with the use
intended.
Page 69 of 72 EN109-1498751-47 IFU

16 Contact
For assistance, please visit our website http://www.enraf-nonius.com
The latest version (in electronic or printed format) of this Instructions for Use can be obtained free of
charge from our website www.enraf-nonius.com or by contacting distributor or by calling the
telephone number: +31-(0)10-2030600.
The Instructions for Use will be sent (free of charge) to you within 7 (seven) calendar days.
17 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 entire liability under any
provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this
product and fees for support of the product received by Enraf-Nonius under a separate support
agreement (if any), with the exception of death or personal injury caused by the negligence of Enraf-
Nonius to the extent applicable law prohibits the limitation of damages in such cases. Enraf-Nonius
cannot be held liable for any consequence resulting from incorrect information provided by its
personnel, or errors incorporated in this manual and / or other accompanying documentation
(including commercial documentation).
The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims
arising from third parties, whatever nature or whatever relationship to the opposing party.
Page 70 of 72 EN109-1498751-47 IFU

Page 71 of 72 EN109-1498751-47 IFU
Copyright: Enraf-Nonius B.V.
Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands
Tel: +31 (0)10-20 30 600 | [email protected]
EN109-1498751-47

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4-SERIES

Instructions for use

Page 1 of 72 EN109-1498751-47 IFU

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StatUSTM Pack 400

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Symbol used Description

Follow the instructions in the Instructions for Use.

General Prohibition Sign.

General mandatory action sign.

Type B applied part complying with the specified requirements to provide

Type BF applied part complying with the specified requirements to provide a

Waste electrical items that can be recycled.

Keep the device dry

Manufacturer name, address and date of manufacture.

Reference Number or Part Number

Page 5 of 72 EN109-1498751-47 IFU

CE Mark along with number indicates conformity with European Council of

Connection electrode cable electrotherapy

Connections vacuum cables electrotherapy

Remote control connection

On/Off push button

Page 6 of 72 EN109-1498751-47 IFU

Type number/warning label Provides information on the apparatus, such as type

[3] Remote Control connection This connection has two functions.

Page 7 of 72 EN109-1498751-47 IFU

Do not connect externally powered USB devices or

The supply current of this connection is limited to

[5] Power LED indicator: Green: Device connected to mains supply.

The ultrasound applicator is a precision instrument.

Page 8 of 72 EN109-1498751-47 IFU

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Ultrasound treatment head

Standard accessories for 4-series

Standard accessories ultrasound

Standard accessories electrotherapy

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Standard accessories vacuum

Moist pads for rubber electrodes

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Vacuum accessories Vacotron 460

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Immediately upon unpacking the device, perform the following steps:

System without a Vacotron

System with a Vacotron

Connection to mains supply

Placing the optional battery

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Operation from battery

Disconnection of mains supply

Systems with a battery

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*= Does not apply to LIPUS (Low Intensity Pulsed Ultrasound)

Page 17 of 72 EN109-1498751-47 IFU

Precautions and warnings

Electrotherapy – Pain management