Enraf-Nonius StatUS Pack 400 User manual

Brand: Enraf-Nonius

Model: StatUS Pack 400

Type: User manual

StatUSTM Pack 400

EN109-1629761-43 IFU

November 8, 2022

Instructions for use

Page 2 of 36 EN109-1629761-43 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............................................................................................................................. 21

12 Maintenance and troubleshooting ........................................................................................................ 23

13 Specifications ................................................................................................................................................. 26

14 Contact ............................................................................................................................................................. 29

15 Product liability ............................................................................................................................................. 29

16 Appendix 1 Library ...................................................................................................................................... 30

Page 3 of 36 EN109-1629761-43 IFU

1 Introduction

Foreword

This manual has been written for the owners and operators of the StatUS™ Pack 400.

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 StatUS™ Pack 400 is a feature (accessory) for the application of StatUS™ therapy and works only

when connected to a Sonopuls 490 / 492 device. StatUS stands for Stationary Ultra Sound: the

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

Comment: the StatUS™ Pack 400 is not designed for use in combination with the Vacotron 460.

Page 4 of 36 EN109-1629761-43 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 36 EN109-1629761-43 IFU

3 Device components

Page 6 of 36 EN109-1629761-43 IFU

4 Package contents

1629902

StatUS™ Pack 400

Standard accessories

0169990

Holder for StatUS™ applicator (pre-assembled)

0629902

StatUS™-applicator 400

3442941

Gelpad StatUS™ (240x)

3442942

Fixation ring gelpad StatUS™ (3x)

1629767

Instructions for Use - StatUS™ Pack 400 (CD-ROM)

1629769

Information booklet StatUS™ Pack 400

Optional accessories

3442941

Gelpad StatUS™ (240x)

3442942

Fixation ring gelpad StatUS™ (3x)

Ordering information

For the ordering data of the 4-series, StatUS™ Pack 400, standard accessories and additional

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

Page 7 of 36 EN109-1629761-43 IFU

5 Installation

The StatUS™ Pack 400 is a feature (accessory) for the application of StatUS™ therapy and only works

when connected to a Sonopuls 490 device (art. no. 1498901, 1498902, 1498903) or a Sonopuls 492

(art.no. 1498911, 1498912, 1498913).*

To connect the StatUS™ Pack 400 with the Sonopuls 490 / 492 place the StatUS™ Pack 400

underneath the Sonopulse 490 / 492.

Connect the StatUS™ Pack 400 connector to the Sonopuls 490 / 492 to connector port B.

The StatUS™ Pack 400 does not have its own power supply and is powered by the Sonopuls 490 / 492.

Operating the device is also done (see Ch. 10) via the control panel (touchscreen) of the Sonopuls 490

/ 492.

Comment: the StatUS™ Pack 400 is not designed for use in combination with the Vacotron 460.

* = 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 400) should be connected at the front (connection B).

The StatUS™ Pack 400 must be placed below the Sonopuls 490 / 492 device.

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 36 EN109-1629761-43 IFU

6 Intended use and intended user

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 490 / 492 with StatUSTM Pack 400 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 ultrasound therapy.

Page 9 of 36 EN109-1629761-43 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 10 of 36 EN109-1629761-43 IFU

8 Contraindications

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 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)

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.

Potential adverse effects

• Cataracts

• Male sterility

• Enhanced drug activity

• Thermal stress

Additionally some information on how the ultrasound should be applied is presented in chapter 11

“Application information” of the user manual.

Page 11 of 36 EN109-1629761-43 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 400 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 400) should be connected at the front (connection B).

The StatUS™ Pack 400 must be placed below the Sonopuls 490 / 492 device.

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.

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.

Page 12 of 36 EN109-1629761-43 IFU

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 400 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 36 EN109-1629761-43 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 490 / 492. The

parameters for StatUS therapy are entered via the (touschscreen) control panel of the Sonopuls 490 /

492.

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 490 / 492 please see the manual (art.no.1498751) for the 4-series. This manual (CD-

ROM) is included with the Sonopuls 490 / 492.

Home menu

The Sonopuls 490 / 492 devices are equipped with touch-

screen operation. Select the desired function by pushing an

icon.

Image: main menu Sonopuls 492

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

connected to terminal A and / or B. If a StatUS™ Pack 400 is connected (connection B), then the

therapy choice “StatUS Therapy” is accessible. When disconnecting the StatUS Pack 400, the function

“StatUS therapy” remains visible in the main menu, until the moment that you stop the power supply.

After switching on the device, the function “StatUS therapy” is no longer visible. Once the StatUS

applicator has been reconnected, the function will appear again in the main menu.

StatUS™ Therapy

• Select StatUS therapy from the main menu

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

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

o Under “Favorites” you can retrieve your stored protocols.

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

Page 14 of 36 EN109-1629761-43 IFU

Clinical Protocols

The Sonopuls 490 / 492 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

• Use the central controller

to scroll through the

pages.

The first page is text followed

by one or more illustrations

Note: the numbers under

Literature are referring to

relevant publications like

shown in the literature list

(Appendix 1).

Push the ✓ icon (“accept”).

The screen shows all

parameters in once glance

• The parameters can be

changed at all times.

• Press button [1] to set

vacuum pressure.

Page 15 of 36 EN109-1629761-43 IFU

• Place the StatUS applicator

on the treatment area and

increase the vacuum pressure

using the central regulator

• Once there is sufficient

contact the pause icon

disappears and treatment

time starts counting

down.

• If contact is insufficient, it

will pause the treatment

time.

• In this case, increase the

vacuum pressure until the

contact is restored.

BE AWARE:

• Once the treatment time has elapsed, the vacuum pressure will still be maintained for 1

minute max. This prevents that the StatUS applicator immediately disengages at the end of

treatment (and possibly drops). The switch-off time for the vacuum pressure can be set in

increments of 1 minute / can be changed via the “sleep setting after…” button in the menu

“System settings”.

• In general, the Amplitude Modulation and Duty Cycle Modulation are always switched on

(=standard setting) *. However, both modulations can be switched on and off manually (see

images below). Caution is advised though. The owner or user of a StatUS Pack 400 will remain

responsible and liable at all times for the use of StatUS, when one or both modulations are

switched off temporarily (also refer to chapter 6, chapter 10 paragraph Manual Operation -

Selecting the parameters: Duty Cycle modulation and Amplitude modulation, chapter 13

paragraph StatUS therapy - Amplitude modulation).

* applies when using the function "Manual" . In some protocols , the modulations are not active.

Page 16 of 36 EN109-1629761-43 IFU

Display if both modulations are

enabled ( active).

Display if Amplitude Modulation

is disabled (inactive).

Display if Duty Cycle

Modulation is disabled

(inactive).

Manual operation

Setting parameters: frequencies

• Press the "Manual

Operation" button

• Select the parameter by

pressing the relevant

button.

• Example: Press button [2]

to change the pulse

frequency

• Change the frequency by

using the central controller.

The ultrasound frequency can be set/adjusted in the same way (1 or 3 MHz).

Page 17 of 36 EN109-1629761-43 IFU

Selecting the parameters: duty cycle modulation and amplitude modulation

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

always active (see chapter 13). This means that – in general – the device is always in pulsed modus and

that the Duty Cycle (and the amplitude) vary continuously. Because of this, the button for selecting the

pulse mode [3] is not accessible.

• Press button [4] to change

the duty cycle.

• There are 7 options: 100,

80, 50, 33, 20, 10 and 5%.

• Select the duty cycle with

the central regulator.

• In this example, the duty

cycle drops from 20% to

10, then goes back up to

20%.

The icon indicates that the

Duty Cycle modulation has

been switched on (is active).

The Duty Cycle modulation and Amplitude modulation can be switched on and off manually (using

the central regulator). Caution is advised though. The owner or user of a StatUS Pack 400 will remain

responsible and liable at all times for the use of StatUS Pack 400, when one or both modulations are

switched off temporarily (also refer to chapter 6, chapter 10 paragraph Clinical protocols, chapter 13

paragraph StatUS therapy - Amplitude modulation).

Page 18 of 36 EN109-1629761-43 IFU

Selecting the parameters: treatment time

• Press button [5] to change

the treatment time.

• Change treatment time

with the central controller.

Selecting the parameters: intensity

• Press button [6] to change

the intensity.

• Change the intensity with

the central regulator.

Note: a pop-up appears if the

selected intensity exceeds the

mean value.

• Press the ✓ button to

continue or to adjust the

intensity.

Page 19 of 36 EN109-1629761-43 IFU

Favorites

Storing protocols

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

saved as 'favorites'.

• First set the desired

parameters.

• Press button [7] to store the

parameters.

• Enter a name for the

program when you save it.

• Press the ✓ button

(“confirm”).

Page 20 of 36 EN109-1629761-43 IFU

Loading favorites

• Press the button

“Favorites”.

• Select the desired

programme from the list of

favorites.

• 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.

Delete favorites

• Press the button

“Favorites”.

• First press the ‘Waste bin’

button [8].

• Press the name of the

favorite you wish to delete.

(e.g. my protocol)

• The favorite will be deleted

and removes from the list.

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Enraf-Nonius StatUS Pack 400 User manual

Enraf-Nonius StatUS Pack 400 User manual

Enraf-Nonius StatUS Pack 400 User manual

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