Enraf-Nonius StatUS Pack 100 User manual

Page 1 of 38 EN109-1629751-43 IFU

StatUSTM Pack 100

EN109-1629751-43 IFU

August 18, 2022

Instructions for use

Page 2 of 38 EN109-1629751-43 IFU

Table of contents

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

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

3 Device components ....................................................................................................................................... 5

4 Package contents ............................................................................................................................................ 6

5 Installation ......................................................................................................................................................... 7

6 Intended use and intended user ............................................................................................................... 8

7 Indications ......................................................................................................................................................... 9

8 Contraindications ......................................................................................................................................... 10

9 Precautionary instructions ........................................................................................................................ 11

10 Operation ........................................................................................................................................................ 13

11 Application information............................................................................................................................. 22

12 Maintenance and troubleshooting ........................................................................................................ 24

13 Specifications ................................................................................................................................................. 27

14 Contact ............................................................................................................................................................. 30

15 Product liability ............................................................................................................................................. 31

16 Appendix 1 Library ...................................................................................................................................... 32

Page 3 of 38 EN109-1629751-43 IFU

1 Introduction

Foreword

This manual has been written for the owners and operators of the StatUS™ Pack 100.

It contains general instructions on operation, precautionary practices, maintenance and parts

information. In order to maximize the use, efficiency and lifespan of your unit, please read this manual

thoroughly and become familiar with the controls as well as the accessories before operating the unit.

Specifications put forth in this manual were in effect at the time of publication. However, owing to

Enraf-Nonius BV’s policy of continual improvement, changes to these specifications may be made at

any time without obligation on the part of Enraf-Nonius BV.

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.

The StatUS™ Pack 100 is a feature (accessory) for the application of StatUS™ therapy and works only

when connected to a Sonopuls 190 device. StatUS stands for Stationary Ultra Sound: the application

of ultrasound without moving the ultrasound treatment head (= stationary).

Page 4 of 38 EN109-1629751-43 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.

Page 5 of 38 EN109-1629751-43 IFU

3 Device components

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4 Package contents

1629901

StatUS™ Pack 100

Standard accessories

0169842

Holder for StatUS™ applicator

0629900

StatUS™-applicator 100

3442941

Gelpad StatUS™ (240x)

3442942

Fixation ring gelpad StatUS™ (3x)

1629757

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

1929750

Information booklet StatUS™ Pack 100

Optional accessories

3442941

Gelpad StatUS™ (240x)

3442942

Fixation ring gelpad StatUS™ (3x)

Ordering information

For the ordering data of the Sonopuls 190, StatUS™ Pack 100, standard accessories and additional

accessories we refer to the website www.enraf-nonius.com.

Page 7 of 38 EN109-1629751-43 IFU

5 Installation

The StatUS™ Pack 100 is a feature (accessory) for the application of StatUS™ therapy and only works

when connected to a Sonopuls 190 * device (art. no. 1631901, 1631902 or 1631903).

To connect the StatUS™ Pack 100 with the Sonopuls 190 please see the "StatUS™ Pack 100

Information Booklet" (1929750). This document is included with the StatUS™ Pack 100.

The StatUS™ Pack 100 does not have its own power supply and is powered by the Sonopuls 190.

Operating the device is also done (see Ch. 10) via the control panel (touchscreen) of the Sonopuls 190.

* = with software V009 or higher.

[A] Connection for (traditional) ultrasound treatment head (left side)

[B] Connection for StatUS™ applicator (right side)

The StatUS applicator / StatUS™ Pack 100) should be connected to the right side

(connection B) only.

The StatUS™ Pack 100 must be mounted on the Sonopuls 190 device in such a way that the

mounting holes are covered at all times.

Do not remove the StatUS™ Pack 100 once it has been mounted on the Sonopuls 190. The

materials are designed for one-time assembly.

The StatUS applicator/ultrasound treatment head is a precision instrument. Effective pooling

of properties was an important focus during development and production. Careless

handling (jarring or dropping) may have a negative effect on these properties and should

therefore be avoided.

A maximum of one channel can be active. You can not work simultaneously with applicator

A and B.

Page 8 of 38 EN109-1629751-43 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.

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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 10 of 38 EN109-1629751-43 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 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.

Page 11 of 38 EN109-1629751-43 IFU

9 Precautionary instructions

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.

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.

This device should be kept out of the reach of children.

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.

This device is not suitable for use in the presence of flammable anesthetics mixture with air,

oxygen, or nitrous oxide.

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).

Do not operate the StatUS™ Pack 100 when connected to any unit other than Enraf-Nonius

BV devices.

Inspect the StatUS™ applicator cables and associated connectors before each use.

The StatUS applicator / StatUS™ Pack 100) should be connected to the right side (connection

B) only.

The StatUS™ Pack 100 must be mounted on the Sonopuls 190 device in such a way that the

mounting holes are covered at all times.

Do not remove the StatUS™ Pack 100 once it has been mounted on the Sonopuls 190. The

materials are designed for one-time assembly.

The StatUS applicator/ultrasound treatment head is a precision instrument. Effective pooling

of properties was an important focus during development and production. Careless handling

(jarring or dropping) may have a negative effect on these properties and should therefore be

avoided.

A maximum of one channel can be active. You can not work simultaneously with applicator A

and B.

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, and must therefore

be avoided.

Use only the original Enraf-Nonius gelpads! Do not use liquid gel as this will be sucked into

the vacuum tubes and pump, causing malfunction! Any warranty claim will be rejected if

liquid gel residue if found in any of these components.

The gelpads are intended for once-only use.

Since the StatUS™ applicator / ultrasound treatment head transfers ultrasound energy into

the tissue at a most efficient and effective way, we advise you to use lower intensity settings

than the usual intensity settings for 'traditional' (semi-stationary or dynamic) ultrasound.

The StatUS applicator and the cable should be regularly inspected for damage, such as cracks,

which could cause fluid to penetrate.

Do not rinse the StatUS applicator under running water!

Never immerse the StatUS applicator in water or other (cleaning) liquids!

For proper cleaning of the StatUS applicator’s contact surface, the rubber cuff may be folded

back on one movement.

Page 12 of 38 EN109-1629751-43 IFU

If necessary, you can push up the StatUS applicator a bit from beneath.

Never fold the entire cuff!

In order to guarantee good transmission of the ultrasound energy, you must use original Enraf-

Nonius gelpads.

Do not use regular (liquid) Sonogel because this will be sucked up into the vacuum pump!

Warranty claims in which the remnants of regular ultrasound gel are found in the pump, hoses

or connections will be rejected by Enraf-Nonius.

To perform well the StatUS™ Pack 100 should be checked this once a year by a service

technician.

No attempt should be made to disassemble the unit. Maintenance and repair should be carried

out by authorized personnel only. Enraf-Nonius will not be held responsible for the results of

maintenance or repairs by unauthorized persons.

Page 13 of 38 EN109-1629751-43 IFU

10 Operation

Basic operation

The parameters for the application of static ultrasound (StatUS therapy) conform for the most part to

the parameters for conventional ultrasound therapy as provided by the Sonopuls 190. The parameters

for StatUS therapy are entered via the (touschscreen) control panel of the Sonopuls 190.

The following is an overview of the specific operating instructions for the application of static

ultrasound therapy with the StatUS applicator. For a general description of the settings and operation

of the Sonopuls 190 please see the manual (art.no.1631750) for the Sonopuls 190. This manual (CD-

ROM) is included with the Sonopuls 190.

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.

Note: The available therapy choices may vary by model and are depending on the accessories

connected to terminal A and / or B. If only a StatUS™ Pack 100 is connected (connection B), then only

the therapy choice “StatUS Therapy” is accessible. The therapy choice 'Ultrasound Therapy” is grayed

and the function is not active. Once a multi-frequency treatment head on channel A is connected, the

function 'Ultrasound Therapy' is clearly visible and accessible (see illustration above).

StatUS™ Therapy

• Select StatUS therapy from the main menu

• Then you can choose from “Clinical Protocols”, “Favourites” and “Manual”.

o Under „Clinical Protocols“ you can retrieve the 52 pre-programmed treatment protocols.

o Under the personal protocols “Favourites” you can retrieve your stored protocols.

o Under manual settings 'Manual', you can set all the parameters.

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Clinical Protocols

The Sonopuls has 52 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.

Note: the numbers under

Literature are referring to

relevante publications like

shown in the literature list

(Appendix 1).

The blocks (see [1]) indicate

where you are in the list.

Confirm the selection with the

“OK” button.

The screen shows all

parameters in once glance

• The parameters can be

changed all time.

• Press button [2] to set

vacuum pressure.

1

2

Page 15 of 38 EN109-1629751-43 IFU

• Place the StatUS applicator

on the treatment area and

increase the vacuum pressure

using the  buttons.

• Once there is sufficient

contact the pause icon

disappears and treatment

time starts counting down.

• Confirm the selection with

the „OK“ button.

• If contact is insufficient, it

will pause the treatment

time.

• In this case, increase the

vacuum pressure until the

contact is restored.

• A small cube, which

rhythmically increases

and decreases, indicates

that the modulations are

active.

Once the treatment time has elapsed, the vacuum pressure will still be maintained for 2 minutes. This

prevents that the StatUS applicator immediately disengages at the end of treatment (and possibly

drops). Before the vacuum pressure definitely closes, there will be an audible beep in the last 15

seconds.

Page 16 of 38 EN109-1629751-43 IFU

Manual operation

Setting parameters: frequencies and units

Press the "Manual Operation"

button

• Select the parameter by

pressing the relevant

button.

• Example: Press button [3]

to change the frequency

• Use the  buttons to

change the frequency.

• Confirm the selection with

the "OK" button.

3

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Selecting the parameters: duty cycle modulation

When using StatUS therapy, the Duty Cycle Modulation (as well as the Amplitude Modulation) is

always active (see chapter 13). This means that the device always operates in pulsation mode with

continuous variation of the Duty Cycle. Because of this, the button for selecting the pulse mode [4] is

not accessible and is greyed out.

• Press button [5] to change

the duty cycle.

Use the  buttons to select

the duty cycle.

• There are 6 options: 100,

80, 50, 33, 20, 10%.

• Confirm the selection with

the "OK" button. This will

automatically take you

back to the previous

screen.

In this example, the duty cycle

drops from 10% to 5%, then

goes back up to 10%.

A rhythmically increasing and

decreasing cube indicates that

the modulations are active.

4

5

Page 18 of 38 EN109-1629751-43 IFU

Selecting the parameters: treatment time

• Press button [6] to change

the treatment time.

• Change treatment time

with the  buttons.

• Confirm the selection with

the “OK” button.

You will automatically return to

the previous screen.

Selecting the parameters: intensity

• Press button [7] to change

the intensity.

Use the  buttons to change

the intensity.

• Confirm the selection with

the "OK" button. This will

automatically take you

back to the previous

screen.

Note: a pop-up appears if the

selected intensity exceeds the

mean value.

• Press "Continue" to keep

going or to adjust the

intensity.

6

7

Page 19 of 38 EN109-1629751-43 IFU

Favourites

Storing protocols

Prior to the implementation of an appropriate protocol or a manually set treatment settings can be

saved as 'favourites'.

• Press button [8] to store

the parameters.

Select a program number using

the  buttons and confirm

the selection with the „ OK“

button.

Note:

Program number 0 Program

number is the preset menu

with which starts the device.

• Enter a name for the

program when you save it.

• Confirm the selection with

the "OK" button.

8

Page 20 of 38 EN109-1629751-43 IFU

Loading favourites

• Press the button

“Favourites”.

Select a program number using

the  buttons.

• The parameter screen with

the stored parameters

appears.

• Next, enter the vacuum

pressure and position the

StatUS applicator.

• The treatment starts

automatically when there is

sufficient contact.

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Enraf-Nonius StatUS Pack 100 User manual

Enraf-Nonius StatUS Pack 100 User manual

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