Enraf Nonius Sonopuls 190 User manual

Page 1 of 34 EN109-1631750-48 IFU
Sonopuls 190
EN109-1631750-48 IFU
July 9, 2020
Instructions for use

Page 2 of 34 EN109-1631750-48 IFU
Table of contents
1Introduction ......................................................................................................................................................3
2Symbols ..............................................................................................................................................................4
3Device components .......................................................................................................................................6
4Package contents............................................................................................................................................7
5Installation .........................................................................................................................................................8
6Intended use and intended user...............................................................................................................9
7Indications ...................................................................................................................................................... 10
8Contraindications......................................................................................................................................... 11
9Precautionary instructions........................................................................................................................ 12
10 Operation........................................................................................................................................................ 14
11 Application information............................................................................................................................. 23
12 Maintenance and troubleshooting........................................................................................................ 25
13 Specifications................................................................................................................................................. 27
14 Contact............................................................................................................................................................. 32
15 Product liability............................................................................................................................................. 33

Page 3 of 34 EN109-1631750-48 IFU
1Introduction
Foreword
This manual has been written for the owners and operators of the Sonopuls 190. 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.
For detailed explanation on installation and operation of the Sonopuls 190 with StatUS™ Pack 100 (for
static ultrasound), we refer you to the operating instructions StatUS™ Pack 100 (art.nr. 1629.750). This
guide (CD-ROM) can be found in the packaging of the StatUS™ Pack 100.
Specifications put forth in this manual were in effect at the time of publication. However, owing to
Enraf-Nonius BV’s policy of continual improvement, changes to these specifications may be made at
any time without obligation on the part of Enraf-Nonius BV.
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.
Device Description
The Sonopuls 190 is a multi-frequency ultrasound unit. The multi-frequency ultrasound applicators for
the 100-serie provide both 1 and 3 MHz operation. The applicators can be used with both, large and
small treatment surfaces and are suitable for subaqual treatments.
Contact control suspends the application of ultrasonic energy when acoustical contact with the
treatment area becomes insufficient.
The user can connect two ultrasound applicators. These can be activated from the ultrasound menu.

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2Symbols
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
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.
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
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.

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Pulse frequency
Continuous
Duty cycle
Pulse duration
Ultrasound frequency
Alternating current
“ON” (power)
“OFF” (power)

Page 6 of 34 EN109-1631750-48 IFU
3Device components
Numbered
Part
Description
Purpose
[1]
LCD display
Colour TFT display 4.3” with touch screen
[2]
Applicator
Ultrasound applicator Multi-frequency 1 and 3 MHz
[3]
Applicator holder
Applicator holder. Can be mounted on the right or left
side of the unit.
[4]
Mains Switch
To switch the unit on and off
When turning the unit off the display remains visible for a
few seconds (low-energy method).
[5]
Connector for mains cable
To disconnect the device from the power line, unplug the
power cord.
[6]
Type number/warning
sticker
Provides information on the apparatus, such as type and
serial number, as well as connection data such as mains
voltage and maximum current consumption.
[7]
Connection Ultrasound
Applicator A
Ultrasound applicator connection left side
[8]
Connection Ultrasound
Applicator B
Ultrasound applicator connection right side
[9]
Contact Control light ring
This LED ring emits yellow color light when the contact
between the treatment area and the applicator is poor.

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4Package contents
1631.901
Sonopuls 190 incl. multi-frequency ultrasound head of 5 cm2
1631.902
Sonopuls 190 incl. multi-frequency ultrasound head of 0,8 cm2
1631.903
Sonopuls 190 incl. 2 multi-frequency ultrasound heads
(5 cm2and 0,8 cm2)
1631.904
Sonopuls 190 incl. StatUS™ Pack 100
Standard accessories for 1631.901, 1631.902 and 1631.903
1631.810
Head holder for multi-frequency treatment head
3442.929
Contact-gel, 1 bottle of 250 ml (1)
3444.357
Mains connecting cable
1631.750
Instructions for Use - Sonopuls 190 (CD-ROM)
0167.154
Information sheet ultrasound gel
1631.761
Information booklet –Sonopuls 190
0167.278
Information sheet - Mounting US Head Holder Sonopuls 190
(1) = The Sonopuls is delivered with 1 bottle of contact-gel. The article number 3442.929 however represents a box of 12 bottles.
Standard accessories for 1631.904
0169.842
Head holder StatUS™ applicator
3442.941
Gelpad StatUS™ (240x)
3442.942
Fixation ring gelpad StatUS™ (3x)
1631.750
Instructions for Use - Sonopuls 190 (CD-ROM)
1629.750
Instructions for Use - StatUS™ Pack 100 (CD-ROM)
1929.750
Information booklet StatUS™ Pack 100
3444.357
Mains connecting cable
1631.761
Information booklet - Sonopuls 190
0167.278
Information sheet - Mounting US Head Holder Sonopuls 190
Optional accessories for Ultrasound / StatUSTM Therapy
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
3442.941
Gelpad StatUS™ (240x)
3442.942
Fixation ring gelpad StatUS™ (3x)
Ordering information
For the ordering data of the Sonopuls 190, standard accessories and additional accessories we refer to
the website www.enraf-nonius.com.

Page 8 of 34 EN109-1631750-48 IFU
5Installation
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.
Mounting the ultrasound head holder
Ultrasound head/applicator holder can be mounted on the right or left of the unit. Follow the
instructions given in the 0167.278 Information sheet - Mounting US Head Holder Sonopuls 190.
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 unit if it is not properly grounded. Make certain that the unit is
electrically grounded by connecting it only to a grounded electrical service receptacle that is
in
conformity with the applicable national and local electrical codes regarding medical
environments.
Insert the mains cable into socket [5] and connect it to a wall socket.
Connect the applicator on socket [7] or [8].

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6Intended use and intended user
The Sonopuls 190 is a unit for continuous and pulsed 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.
The Sonopuls 190 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 ultrasound therapy.

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7Indications
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.

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8Contraindications
The Sonopuls 190 MUST NOT be used for the below mentioned symptoms or medical
conditions.
Contraindications
•The established contraindications to heat therapy itself.
•In an area of the body where a malignancy is known to be present.
•Over or near bone growth centers until bone growth is complete.
•Over the thoracic area if the patient is using a cardiac pacemaker.
•Over a healing fracture.*
•Over ischemic tissues in individuals with vascular disease where the blood supply would be
unable to follow the increase in metabolic demand and tissue necrosis might result.
•In the presence of metal implants of any type.*
•Patients with sensory loss on the area to be treated.
•The gonads or pregnancy.
•The heart.
•The brains.
•The testicles.
•The eyes.
•Unconscious patients.
* = Does not apply to LIPUS (Low Intensity Pulsed Ultrasound)
Precautions and Warnings
•Precaution should be taken when using therapeutic ultrasound on patients with hemorrhagic
diatheses.
•Ultrasound treatment presents a potential safety hazard in patients whose pain response has been
decreased because of disease, previous surgery, ionizing radiation therapy, chemotherapy, or
general or regional anaesthesia. It may cause burns. Do not use on insensitive areas or in the
presence of poor circulation.
•Large thermal doses could result in regions of thermal aseptic necrosis which could not be
apparent on inspection of the skin.
•Always ensure proper hygiene. (see chapter 12 Maintenance and troubleshooting)
•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.
•See also chapter 9 of the user manual, Precautionary Instructions, for general Warnings and
Precautions.
Relevant Hazards
•Use of ultrasound in treating areas above the shoulders may pose relevant hazards. While it is
recognized that certain specific conditions involving the eyes can and have been treated by
qualified specialists, with knowledge and experience to administer such treatments, such
application carries with it recognized hazards of applying heat to the eyes.
•Treatment of the thyroid, as well as lymph nodes in the neck, may expose the patient to as yet
undetermined effects inasmuch as the safety of such treatments has not yet been established.
Additionally some information on how the ultrasound should be applied is presented in chapter 11
“Application information” of the user manual.

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9Precautionary 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!
In case of damage from transport is noticed, contact your local distributor.
DO NOT USE the device!
The device should not be used when any sort of mechanical damage is noticed.
Do not place the device in a location where the power cord could be tripped over or pulled
out during treatment!
It is recommended that the Sonopuls 190 should not be used after extreme temperature
fluctuations.
Federal law (USA only) restricts this device to sale by, or on the order of, a physician or
licensed practitioner. This device should be used only under the continued supervision of a
physician or licensed practitioner.
Make certain that the unit is electrically grounded by connecting only to a grounded electrical
service receptacle conforming to the applicable national and local electrical codes.
Do not operate the unit in an environment of short-wave or micro-wave diathermy use as this
can result in burns beneath the electrodes.
Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to
minimize this interference by not using other equipment in conjunction with it.
This equipment is not suitable for use in the presence of flammable anaesthetic mixture with
air, oxygen, or nitrous oxide.
This device should be kept out of the reach of children.
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
Handle ultrasound applicator with care. Inappropriate handling of the ultrasound applicator
may adversely affect its characteristics.
Inspect ultrasound applicator for cracks and other mechanical defects which may allow the
ingress of conductive fluid before each use.
Inspect ultrasound applicator cables and associated connectors before each use.
Do not operate the Sonopuls 190 when connected to any unit other than Enraf-Nonius BV
devices.
This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F),
with a Relative Humidity ranging from 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. Consult other resources for additional
information regarding the application of ultrasound therapy.
Always determine the dosage based on the patient’s perception of heat. Any sensation
greater than mild warmth could cause a burn.
Do not use this device in so called “Wet Rooms” (hydrotherapy rooms).
The device should be installed in such a way, that its warmth can be passed on to the
surroundings. Do not cover the ventilation openings.
Before performing any user maintenance, switch off the device and disconnect the plug from
the mains supply.

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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!
Electrical safety of the device relies on a proper earthed electrical connection via the power
cord. It is therefore necessary to have this connection checked annually.
To ensure continued compliance with the 21 CFR 1050.10 standard, this unit should be
adjusted and safety tested once each year. Procedures laid down in the service manual should
be followed. This may be carried out by your supplier, or by another agency, authorized by
the
manufacturer. It is also recommended that a service history record is maintained. In some
countries this is even obligatory.
Use of controls or adjustments or performance of procedures other than those specified in
the service manual may result in hazardous exposure to ultrasonic energy.
This unit operates with mains 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.
Medical electrical devices such as the Sonopuls 190 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 RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of the Sonopuls 190,
including cables specified by the manufacturer. Otherwise degradation of the performance of
this equipment could result.
The Sonopuls 190 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.

Page 14 of 34 EN109-1631750-48 IFU
10 Operation
Switch on
•Switch the unit On via the [4].
•The unit starts by executing the self test
•At the end of the self test the unit enters the Home menu and is ready for use.
Note:
StatUS Therapy is enabled automatically only for Sonopuls 190 (Part number 1631.904) that comes with
StatUSTM pack (Part number 1629.901).
For Sonopuls 190 (Part numbers 1631.901, 902 or 903) has to be connected to StatUSTM Pack 100 (Part
number 1629.901) in order to perform StatUS Therapy. StatUSTM Pack 100 is a feature (accessory) for the
application of StatUS Therapy. Hence for 1631.901,902 or 903, this accessory will have to be purchased
separately.
Home menu
The Sonopuls 190 is equipped with touch screen technology. Via the
menu you have access to all functions. Select the desired function by
pushing an icon.

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System Settings
Set Language
•Push the icon “System
Settings”.
Select from the list Language:
•Push icon “Language”
•Select your language via
the  icon
•Push OK to confirm and to
return to the previous
menu
Set Brightness
Select from the list Brightness:
•Push icon “Brightness”
•Adjust the brightness via the
 icon
Push OK to confirm and to
return to the previous menu

Page 16 of 34 EN109-1631750-48 IFU
Select Ultrasound Norm
Here you can select the ultrasound standard. The Sonopuls 190 offers 2 standards, the USA (FDA) and
the EU standard. Default setting is the USA standard.
To select a different standard, push the Ultrasound Standard icon and select another standard via the
 icons. Push OK icon in the screen to confirm and to return to the previous menu.
System Info
Here you can find all information about your unit. Installed software is directy displayed on the left
side of the system info icon. To view all other info’s, push the System info icon and you have all other
information about hardware on the screen.
Push OK icon in the screen to confirm and to return to the previous menu.
Load Clinical Protocols
The Sonopuls has 25 treatment
suggestions for the most
common treatments for
ultrasound.
•Push the icon “Clinical
Protocols” to activate the
list.
Select in the list the treatment
suggestion or:
•Push icon for more
therapy information about
the protocol
•Push the  icon to scroll
in the list.

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The parameter screen shows all
parameters at a glance
•Push the intensity read-out
to change the intensity
level.
Applicator and other
parameters are changeable any
time
•Adjust the intensity level
via the  icon.
•Push OK icon to return in
the previous menu
•Place the applicator on the
treatment area (with gel).
•Contact control indicator
turns off and the treatment
time start (to countdown)
•If there is insufficient
contact, the indicator will
light up and treatment
time will interrupt.

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Manual Operation
Ultrasound Frequency
•Push the action icon
“Manual Operation” to
activate this function
Select a parameter in the
screen by pushing the icon.
•Push icon [1] to change the
frequency.
Select the frequency by
pushing the icon.
•1 MHz is deep
•3 MHz is superficial
You will return to the previous
menu.
Continuous / Pulsed Mode
•Push the icon [2] to select
continuous or pulsed mode
Push A or B
•A is pulsed mode
•B is continuous mode
Push OK to confirm and to
return to the previous menu
If continuous pulse mode is
selected no other parameters
(Frequency or Duty Cycle) are
available.
1
2
A
B

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Pulse Frequency
•Push the icon [3] to select
pulse frequency
Select the pulse frequency via
the  icon.
•There are 3 frequencies
available 100, 48 and 16Hz
•Push OK to confirm and to
return to the previous menu
Duty Cycle
•Push the icon [4] to select
Duty Cycle
Select the duty cycle via the
 icon.
•There are 6 settings
available 80, 50, 33, 20, 10
and 5%
•Push OK to confirm and to
return to the previous menu
3
4

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Applicator selection
•Push the icon [5] to select
the applicator
Select the applicator A or B by
pushing the icon.
Push OK to confirm and to
return to the previous menu
•A is the left connection
•B is the right connection
Note: When no applicator is
connected on the selected
output a beeb will occur.
Units
•Push the icon [6] to select
“units”
Select the desired read-out of
the ultrasound intensity.
•There are 2 read-outs,
Watt/cm² and Watt.
•You will return to the
previous menu
5
6