Enraf Nonius 4 Series User manual

Page 1 of 72 EN109-1498751-47 IFU
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 2 of 72 EN109-1498751-47 IFU
Table of contents
1Introduction ......................................................................................................................................................3
2Symbols ..............................................................................................................................................................5
3Device components .......................................................................................................................................7
4Package contents......................................................................................................................................... 10
5Installation ...................................................................................................................................................... 13
6Intended use and intended user............................................................................................................ 15
7Indications ...................................................................................................................................................... 16
8Contraindications......................................................................................................................................... 17
9Precautionary 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 3 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 4 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 5 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

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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 7 of 72 EN109-1498751-47 IFU
3 Device components
Parts of the device
Parts description
Numbered
Part
Description
Purpose
[1]
Power line switch
0 Device disconnected from mains supply
1 Device connected to mains supply
[2]
Connector for mains cable
Type number/warning label
Connect supplied mains cable here to power the
device.
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 8 of 72 EN109-1498751-47 IFU
Numbered
Part
Description
Purpose
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
technology:
User Interface that allows the operator to control the
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
Electrotherapy channel 1
Connection point for the patient cable for Channel
1.
[9]
Connection for Electrode Cable
Electrotherapy channel 2
Connection point for the patient cable for Channel
2.
[10]
Multifunctional Connector for
accessories Channel A
Connection point to connect accessories such as
Ultrasound head or StatUSTM Pack 400
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,
[11]
Multifunctional Connector for
accessories Channel B

Page 9 of 72 EN109-1498751-47 IFU
Numbered
Part
Description
Purpose
and must therefore be avoided.
[12]
Connections Vacuum Cables
Electrotherapy channel 1
Connection point for the Vacuum Patient leads for
Channel 1.
[13]
Connections Vacuum Cables
Electrotherapy channel 2
Connection point for the Vacuum Patient leads for
Channel 2.
[14]
Interconnection cable vacuum
unit to main unit
Connection cable to connect the Vacuum unit with
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 10 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:
Part Number
Description
1630.905
Ultrasound Head Large
1630.915
Ultrasound Head Small
Standard accessories for 4-series
Part Number
Description
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
Part Number
Description
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
Part Number
Description
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 11 of 72 EN109-1498751-47 IFU
Part Number
Description
2 x 3444.211
Patient cable 2-core & 2 mm male plugs - black, with coloured clips
Standard accessories vacuum
Part Number
Description
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
Part Number
Description
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
Part Number
Description
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
Part Number
Description
3444.128
Rubber electrodes 4x6 cm, 2 mm female, set of 2
3444.129
Rubber electrodes 6x8 cm, 2 mm female, set of 2
3444.130
Rubber electrodes 8x12 cm, 2 mm female, set of 2
Moist pads for rubber electrodes
Part Number
Description
1460.273
Moist pads for rubber electrodes 4x6 cm, set of 4
1460.266
Moist pads for rubber electrodes 6x8 cm, set of 4
1460.275
Moist pads for rubber electrodes 8x12 cm, set of 4
Fixation straps
Part Number
Description
3444.020
Strap 100x3 cm
3444.021
Strap 250x3 cm
3444.022
Strap 100x5 cm

Page 12 of 72 EN109-1498751-47 IFU
Part Number
Description
3444.023
Strap 250x5 cm
Point electrodes
Part Number
Description
3444.180
Point Electrode (pen model), 5 mm Ø, 2 mm female, incl 10 conductive rubber caps
Adapters
Part Number
Description
2523.524
Adapter plug, 2 mm female, 4 mm male, red
2523.523
Adapter plug, 2 mm female, 4 mm male, black
Patient cable
Part Number
Description
3444.211
Patient cable 2-core & 2 mm male plug - black, with colored clips
Remote control
Part Number
Description
1498.800
Remote control 4-series
Bag
Part Number
Description
3444.675
Carrierbag 4-series
Battery
Part Number
Description
2501.016
Battery 12.0V 1.8AH
Vacuum accessories Vacotron 460
Part Number
Description
3444.509
Vacuum electrodes Ø 30 mm, set of 2
3444.503
Vacuum electrodes Ø 60 mm, set of 2
3444.504
Vacuum electrodes Ø 90 mm, set of 2
3444.516
Sponges Ø 30 mm, set of 4 (for vacuum electrodes Ø 30 mm)
3444.505
Sponges Ø 65 mm, set of 4 (for vacuum electrodes Ø 60 mm)
3444.506
Sponges Ø 95 mm, set of 4 (for vacuum electrodes Ø 90 mm)
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 13 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
damage that may have occurred during shipment.
•Place the vacuum unit on a desk or EN-Car. Ensure that there is sufficient air flow below the device
(do not place the device on a table-cover).
•Remove the 4-series device and any additional items ordered from the carton and inspect for
damage that may have occurred during shipment.
•Place the main device on top of the vacuum unit.
•Carefully lift the main device at the front and insert flat cable [17] into connector [18].
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 14 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 15 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.

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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 17 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 18 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.
See also chapter 9 for general warnings and precautions.
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 19 of 72 EN109-1498751-47 IFU
conductive medium, or alternate electrode placement.
See also chapter 9 for general warnings and precautions.
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 20 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.