Enraf-Nonius CD-ROM Sonopuls 190 Manuale utente

Page 1 of 34 EN109-1631750-4A IFU

Sonopuls 190

EN109-1631750-4A IFU

October 26, 2022

Instructions for use

Page 2 of 34 EN109-1631750-4A IFU

Table of contents

1 Introduction ...................................................................................................................................................... 3

2 Symbols .............................................................................................................................................................. 4

3 Device components ....................................................................................................................................... 6

4 Package contents ............................................................................................................................................ 7

5 Installation ......................................................................................................................................................... 8

6 Intended use and intended user ............................................................................................................... 9

7 Indications ...................................................................................................................................................... 10

8 Contraindications ......................................................................................................................................... 11

9 Precautionary 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 EN109-1631750-4A IFU

1 Introduction

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. 1629757). 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.

Page 4 of 34 EN109-1631750-4A 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

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.

Pulse frequency

Continuous

Page 5 of 34 EN109-1631750-4A IFU

Duty cycle

Pulse duration

Ultrasound frequency

Alternating current

“ON” (power)

“OFF” (power)

Page 6 of 34 EN109-1631750-4A IFU

3 Device 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.

Page 7 of 34 EN109-1631750-4A IFU

4 Package contents

1631901

Sonopuls 190 incl. multi-frequency ultrasound head of 5 cm2

1631902

Sonopuls 190 incl. multi-frequency ultrasound head of 0.8 cm2

1631903

Sonopuls 190 incl. 2 multi-frequency ultrasound heads

(5 cm2 and 0.8 cm2)

1631904

Sonopuls 190 incl. StatUS™ Pack 100

Standard accessories for 1631901, 1631902 and 1631903

1631810

Head holder for multi-frequency treatment head

3442929

Contact-gel, 1 bottle of 250 ml (1)

3444357

Mains connecting cable

1631750

Instructions for Use - Sonopuls 190 (CD-ROM)

0167154

Information sheet ultrasound gel

1631761

Information booklet – Sonopuls 190

0167278

Information sheet - Mounting US Head Holder Sonopuls 190

(1) = The Sonopuls is delivered with 1 bottle of contact-gel. The article number 3442929 however represents a box of 12 bottles.

Standard accessories for 1631904

0169842

Head holder StatUS™ applicator

3442941

Gelpad StatUS™ (240x)

3442942

Fixation ring gelpad StatUS™ (3x)

1631750

Instructions for Use - Sonopuls 190 (CD-ROM)

1629757

Instructions for Use - StatUS™ Pack 100 (CD-ROM)

1929750

Information booklet StatUS™ Pack 100

3444357

Mains connecting cable

1631761

Information booklet - Sonopuls 190

0167278

Information sheet - Mounting US Head Holder Sonopuls 190

Optional accessories for Ultrasound / StatUSTM Therapy

3442929

Contact-gel, bottle 250 ml, box of 12

3442930

Contact-gel, bottle 850 ml, box of 12

3442931

Contact-gel, canister of 5 l

3442932

Dispenser-set for 5 l canister

3442941

Gelpad StatUS™ (240x)

3442942

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 EN109-1631750-4A 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.

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 0167278 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].

Page 9 of 34 EN109-1631750-4A IFU

6 Intended 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.

Page 10 of 34 EN109-1631750-4A IFU

7 Indications

Ultrasound is indicated for conditions that benefit from the application of deep heat: relief of pain,

muscle spasms and joint contractures. The objective of therapeutic ultrasound in the treatment of

selected medical conditions associated with the chronic and sub chronic conditions of

bursitis/capsulitis, epicondylitis, ligament sprains, tendinitis, scar tissue healing and muscle strain,

is to reduce pain.

Page 11 of 34 EN109-1631750-4A IFU

8 Contraindications

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 could 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.

Page 12 of 34 EN109-1631750-4A IFU

9 Precautionary instructions

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.

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.

Page 13 of 34 EN109-1631750-4A IFU

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 EN109-1631750-4A 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 1631904) that comes with

StatUSTM pack (Part number 1629901).

For Sonopuls 190 (Part numbers 1631901, 1631902 or 1631903) has to be connected to StatUSTM Pack

100 (Part number 1629901) in order to perform StatUS Therapy. StatUSTM Pack 100 is a feature

(accessory) for the application of StatUS Therapy. Hence for 1631901, 1631902 or 1631903, 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.

Page 15 of 34 EN109-1631750-4A IFU

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 EN109-1631750-4A 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.

Page 17 of 34 EN109-1631750-4A IFU

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.

Page 18 of 34 EN109-1631750-4A IFU

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

Page 19 of 34 EN109-1631750-4A IFU

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

Page 20 of 34 EN109-1631750-4A IFU

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

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