Enraf-Nonius StatUS Pack 400 User manual

Brand: Enraf-Nonius

Model: StatUS Pack 400

Type: User manual

StatUSTM Pack 400

Operating Instructions

Enraf-Nonius B.V.

Vareseweg 127

3047 AT Rotterdam

The Netherlands

Tel: +31 (0)10 – 20 30 600

Fax: +31 (0)10 – 20 30 699

[email protected]

www.enraf-nonius.com

Part number: 1629.761-42

November 10, 2016

Table of contents

1FOREWORD ......................................................................................................................................... 5

1.1This manual ...................................................................................................................................... 5

1.2Product liability ................................................................................................................................ 5

2PRODUCT DESCRIPTION ................................................................................................................... 5

3PRECAUTIONARY INSTRUCTIONS ................................................................................................... 6

4INTENDED USE ULTRASOUND THERAPY AND STATUS™ ........................................................... 8

4.1Ultrasound ........................................................................................................................................ 8

4.1.1Indications/Contraindications and Adverse Effects for Ultrasound ............................................................. 8

4.1.2Parameters ................................................................................................................................................ 9

4.2StatUS Therapy ................................................................................................................................ 9

4.2.1Duty Cycle Modulation ............................................................................................................................... 9

4.2.2Amplitude Modulation .............................................................................................................................. 10

5PACKAGE CONTENTS ...................................................................................................................... 10

5.1Standard accessories .................................................................................................................... 10

5.2Optional accessories ..................................................................................................................... 10

6INSTALLATION .................................................................................................................................. 11

7APPLICATION NOTES ....................................................................................................................... 11

7.1Ultrasound (general) ...................................................................................................................... 11

7.1.1Contact Control ........................................................................................................................................ 11

7.1.2The contact medium ................................................................................................................................ 11

7.1.3Before treatment ...................................................................................................................................... 12

7.1.4During treatment ...................................................................................................................................... 12

7.1.5After treatment ......................................................................................................................................... 12

7.2StatUS™ .......................................................................................................................................... 12

7.2.1The StatUS™ applicator .......................................................................................................................... 12

7.2.2Applying the fixation ring .......................................................................................................................... 12

7.2.3Applying the gelpad ................................................................................................................................. 12

8OPERATING INSTRUCTIONS ........................................................................................................... 14

8.1General ............................................................................................................................................ 14

8.1.1Basic operation ........................................................................................................................................ 14

8.1.2Main menu ............................................................................................................................................... 14

8.2StatUS™ Therapy ........................................................................................................................... 14

8.3Clinical Protocols ........................................................................................................................... 15

8.4Manual Operation ........................................................................................................................... 17

8.4.1Setting parameters: frequencies .............................................................................................................. 17

8.4.2Selecting the parameters: Duty Cycle modulation and Amplitude modulation ......................................... 17

8.4.3Selecting the parameters: Treatment time .............................................................................................. 18

8.4.4Parameters instellen: Intensity ................................................................................................................ 18

8.5Favorites ......................................................................................................................................... 19

8.5.1Storing protocols ...................................................................................................................................... 19

8.5.2Loading favorites ...................................................................................................................................... 19

8.5.3Delete favorites ........................................................................................................................................ 20

9MAINTENANCE AND TROUBLESHOOTING .................................................................................... 20

9.1Maintenance by the user ................................................................................................................ 20

9.1.1Cleaning of apparatus .............................................................................................................................. 20

9.1.2Cleaning of the StatUS applicator ............................................................................................................ 20

9.2Troubleshooting ............................................................................................................................. 21

9.2.1Error code ................................................................................................................................................ 21

9.3Technical Maintenance .................................................................................................................. 21

9.4End of life ........................................................................................................................................ 22

10SPECIFICATIONS ........................................................................................................................... 22

10.1Ultrasound parameters .................................................................................................................. 22

10.2Technical data ................................................................................................................................. 22

11APPENDIX I LIBRARY .................................................................................................................... 23

1 Foreword

1.1 This manual

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.

This medical equipment is intended exclusively for use by or under the supervision of individuals who use

the equipment as part of their work in the context of professional healthcare, who understand the benefits

and limitations of electro and ultrasound therapy. In other words, "professional users".

WARNING (USA only):

The Sonopuls 490 / 492 with StatUS™ Pack 400 device should be used only under the continued

supervision of a physician or licensed practitioner.

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.

For a detailed explanation of the installation and operation of the Sonopuls 490 / 492 please see the 4-

series user manual. This manual (on CD-ROM; art.no.1498757) is included with the Sonopuls 490 / 492.

1.2 Product liability

A law on Product Liability has become effective in many countries. This Product Liability law implies,

amongst other things, that once a period of 10 years has elapsed after a product has been brought into

circulation, the manufacturer can no longer be held responsible for possible shortcomings of the product.

To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or

resellers be liable for any indirect, special, incidental or consequential damages arising from the use of or

inability to use the product, including, without limitation, damages for loss of goodwill, work and

productivity, computer failure or malfunction, or any and all other commercial damages or losses, even if

advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or

otherwise) upon which the claim is based. In any case, Enraf-Nonius’s entire liability under any provision

of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for

support of the product received by Enraf-Nonius under a separate support agreement (if any), with the

exception of death or personal injury caused by the negligence of Enraf-Nonius to the extent applicable

law prohibits the limitation of damages in such cases.

The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims

arising from third parties, whatever nature or whatever relationship to the opposing party.

2 Product 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.

3 Precautionary Instructions

In this section general Warnings and Precautions are listed, that you should be aware of when using the

StatUS™ Pack 400.

DO’S: 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.

Read, understand and practice the precautionary and operating instructions. Know the limitations

and hazards associated with using any electrical stimulation device. Observe the precautionary

and operational decals placed on the unit. Use of controls or adjustments or performance of

procedures other than those specified herein may result in hazardous exposure to ultrasonic

energy.

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.

DONT’S:

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.

WARNING:

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 anesthesia. It may cause burns. Do not use on insensitive areas or in the

presence of poor circulation.

Large thermal doses may result in regions of thermal aseptic necrosis which may not be apparent

on inspection of the skin.

Use of ultrasound in treating areas above the shoulders may pose relevant hazards. While it is

recognized that certain specific conditions involving the eyes can and have been treated by

specialists qualified by training, knowledge and experience to administer such treatments, such

application carries with it recognized hazards of applying heat to the eyes.

Treatment of the 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.

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.

Always ensure proper hygiene (see 9.1 for cleaning). Only apply the ultrasound treatment head

on intact skin. When treating damaged skin (for example ulcers), only place the treatment head

on the edges of the wound, never on the wound itself.

CAUTION:

This unit should be operated, transported and stored in temperatures as indicated in section 10.4

(technical data).

Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive amounts of

dust, moisture, vibrations and mechanical shocks.

The ultrasound treatment head 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.

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.

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.

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!

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

which could cause fluid to penetrate.

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.

The StatUS™ applicator / StatUS™ Pack 400 should be connected at the front (connector B).

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

and B.

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

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

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.

Find out what the local regulations for waste management are before disposing of the unit.

SYMBOLS

General warning sign

Warning is used to mean, “There is certain danger”

A Warning explains dangers that might result in personal injury or death.

General caution sign

Caution is used to mean, “There is certain danger”

A Caution explains hazards that could damage a product, including data loss.

General prohibition sign

Prohibition is used to mean, “You must not…”

General mandatory action sign

Mandatory action is used to mean, “You must…”

Follow the instructions in the user manual.

Read, understand and practice the precautionary and operating instructions.

4 Intended Use ultrasound therapy and StatUS™

4.1 Ultrasound

Ultrasound is a mechanical energy consisting of high-frequency vibrations applied by means of an

ultrasound treatment head. 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.

4.1.1 Indications/Contraindications and Adverse Effects for Ultrasound

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.

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 fetus.

 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 anesthesia. It may cause burns. Do not use on

insensitive areas or in the presence of poor circulation.

Large thermal doses may result in regions of thermal aseptic necrosis which may not be

apparent on inspection of the skin.

Always ensure proper hygiene (see 9.1 for cleaning). Only apply the ultrasound treatment head

on intact skin. When treating damaged skin (for example ulcers), only place the treatment head

on the edges of the wound, never on the wound itself.

Use of ultrasound in treating areas above the shoulders may pose relevant hazards. While it is

recognized that certain specific conditions involving the eyes can and have been treated by

specialists qualified by training, knowledge and experience to administer such treatments, such

application carries with it recognized hazards of applying heat to the eyes.

Treatment of the 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.

See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.

Potential Adverse Effects:

 Cataracts.

 Male sterility.

 Enhanced drug activity.

 Thermal stress.

4.1.2 Parameters

Ultrasound Frequency, expressed in MHz, is the frequency of the ultrasound waves. The ultrasound

frequency determines the penetration depth, which has the largest value at 1 MHz. The ultrasound

frequency can be set at 1 MHz or 3 MHz.

Duty Cycle, expressed in %, defines the ratio of the pulse duration to the pulse repetition time.

Ultrasound can be applied in pulsed or in continuous mode. When the Duty Cycle is set to 100%, the

apparatus operates in continuous mode.

Effective Radiation Area (ERA) expressed in cm², defines the cross-sectional area of the ultrasound

beam (See technical specifications for details). The Effective Radiation Area is fixed and defined by the

size of the ultrasound applicator.

Ultrasound Power is the ultrasound output expressed in W. The ultrasound output display can be

toggled between W and W/cm². In pulsed mode the power during the pulse is displayed. The time

averaged power can be obtained by multiplying this value with the Duty Cycle.

Ultrasound Amplitude, expressed in W/cm², is the quotient of Ultrasound Power and Effective Radiation

Area. The ultrasound output display can be toggled between W and W/cm². In pulsed mode the

Amplitude during the pulse is displayed. The time-averaged Amplitude can be obtained by multiplying this

value with the Duty Cycle.

4.2 StatUS Therapy

StatUS stands for Stationary Ultra Sound: the application of ultrasound without moving the ultrasound

treatment head (= stationary). In the normal course of events, ultrasound energy is administered by

moving (‘making circles’) the treatment head. This moving of the treatment head (also called the dynamic

or semi-stationary method) is essential because a few unfavourable phenomena occur both within an

ultra-sound bundle as well as in the tissue, which may lead to tissue, damage (so-called ‘hot spots’).

StatUS-therapy, on the other hand, makes use of two special forms of modulation that ensure that the

peaks in intensity in the ultra-sound bundle are strongly reduced, diminishing the risk of cavitation and

preventing the occurrence of ‘hotspots’.

These modulation forms are:

1. Duty Cycle Modulation

2. Amplitude Modulation

4.2.1 Duty Cycle Modulation

Duty cycle can be described as the proportion between the duration of the pulse and the duration of the

interval. The duty cycle is expressed in a percentage (%). The device is working in a continuous modus

when the duty cycle is 100%.

Duty cycle modulation implies that the duty cycle fluctuates automatically in a flowing pattern. The

modulation is characterised by a fixed duration of a total of 12 seconds, during which time the (pre) set

duty cycle goes to 5% and back again. So, if the duty cycle is set at 50%, then it will gradually drop to 55

in 6 seconds and then increase again from 5% to 50% in 6 seconds as well. And so the modulation

actually ensures that the pulse duration is automatically reduced or increased.

Duty Cycle Modulation (example of the modulation when Duty Cycle is set at 50%).

4.2.2 Amplitude Modulation

Amplitude Modulation involves varying the ultra-sound intensity. This form of modulation is also

characterised by a rhythmic period of 12 seconds. The intensity (W/cm2) is set at 100%. The intensity will

gradually drop from 100% to 85% in the first 6 seconds, after which it will increase back up to 100% in the

next 6 seconds.

Amplitude Modulation (example of the modulation when intensity is set at 1.0 W/cm2).

In general, both modulations are always engaged (standard setting) * and synchronised (in phase) for the

Sonopuls 490 / 492 with StatUS™ Pack 400. This ensures the greatest possible difference between the

minimum and maximum level of the effective output. However, both modulations can be switched on and

off manually. Caution is advised though. The owner or user of a StatUS Pack 400 will remain responsible

and liable for the use of StatUS when one or both modulations are switched off temporarily (also refer to

1.1, 8.3 and 8.4.2).

* Applies to the use of the "Manual Operation" function. In a few of the protocols the modulations are not active. .

NB: You can find more information about StatUS™ therapy and LIPUS (Low Intensity Pulsed Ultrasound)

in the "StatUS™ Therapy Guide". This therapy manual (pdf) is available for downloading at: www.enraf-

nonius.com/status (English, German and French only).

5 Package Contents

StatUS™ Pack 400 (art.nr. 1629902)

5.1 Standard accessories

0169990 Holder for StatUS™ applicator (pre-assembled)

0629902 StatUS™-applicator 400

3442941 Gelpad StatUS™ (240x)

3442942 Fixation ring gelpad StatUS™ (3x)

1629760 Instructions manual StatUS™ Pack 400 (CD-Rom)

1629769 Information Booklet StatUS™ Pack 400

5.2 Optional accessories

3442941 Gelpad StatUS™ (240x)

3442942 Fixation ring gelpad StatUS™ (3x)

6 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. 1498.901, 902, 903) or a Sonopuls 492 (art.no.

1498.911, 912, 913).*

To connect the StatUS™ Pack 400 with the Sonopuls 490 / 492 please see the "StatUS™ Pack 400

Information Booklet" (1629769). This document is included with the StatUS™ Pack 400.

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. 8) 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.

* = Devices with software version 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 (connector 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

7 Application Notes

7.1 Ultrasound (general)

7.1.1 Contact Control

The StatUS applicator has a contact control function that suspends treatment when the acoustical contact

with the body drops below a certain level. The display will show the symbol “Pause” ” ( ▌▌) and you will

hear an accoustic sound. When contact restoration is sensed the treatment is resumed at the set

amplitude.

7.1.2 The contact medium

To ensure efficient transfer of energy, a contact medium is required between the ultrasound treatment

head and the body. Air causes virtually total reflection of the ultrasound energy. A gelpad should be used

to transfer ultrasound energy via the StatUS applicator.

7.1.3 Before treatment

• Check the patient for contraindications.

• Test the warmth sensibility of the treatment area.

• To optimize ultrasound transmission, clean the skin of the treatment area.

• Strong hair growth has to be shaved.

7.1.4 During treatment

• During treatment the displayed ultrasound amplitude can vary around the set value, caused by

fluctuations in acoustical coupling.

• Ask the patient regularly for his/her findings. If necessary the treatment will have to be adapted. The

amplitude can be reduced.

The ultrasound treatment head 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.

7.1.5 After treatment

• Clean the skin of the patient and the ultrasound treatment head with a towel or tissue.

• Clean the treatment head with a 70% alcohol solution. We recommend the cleaning agent Dismozon®

(Art 3,442,438) in a solution of 0.25 to 1.5%.

• Check for the effects that can be expected (for example pain, circulation and mobility).

• Ask the patient to inform the therapist of any reactions.

7.2 StatUS™

7.2.1 The StatUS™ applicator

A special gelpad is placed on the head for a proper transfer of the ultra-sound energy. Do not use regular

(fluid) Sonogel, as it is sucked into the vacuum pump.

The gelpad is held in position using a fixation ring. The vacuum pressure ensures that the head can be

placed on the body quickly and easily and that the head remains in contact with the body surface.

7.2.2 Applying the fixation ring

Press the fixation included across the treatment head (see photograph hereunder).

Make sure that the ridge on the inner side of the fixation [A] falls in the groove of the StatUS™ applicator

[B].

7.2.3 Applying the gelpad

Place a gelpad in the ring (see photograph). The StatUS™ applicator is now ready for use. Instructions

are supplied with the gel pads. Read these carefully.

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.

8 Operating Instructions

8.1 General

8.1.1 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 (touchscreen) 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.1498.750) for the 4-series. This manual (CD-ROM) is

included with the Sonopuls 490 / 492.

8.1.2 Main menu

The Sonopuls 490 / 492 devices are equipped with touch-screen operation.

De Sonopuls 490 / 492 apparaten zijn uitgevoerd met een touch-screen bediening. 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.

8.2 StatUS™ Therapy

 Select StatUS therapy from the main menu

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

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

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

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

8.3 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 regulator to

scroll through the pages.

The first page is text followed by

one or more illustrations

Note: the numbers under

Literature are referring to

relevante 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 all time.

 Press button [1] to set

vacuum pressure.

 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 1.1, 4.2 and 8.4.2).

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

Display if both modulations are

enabled ( active).

Display if Amplitude Modulation is

disabled (inactive) .

Display if Duty Cycle Modulation is

disabled (inactive).

8.4 Manual Operation

8.4.1 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

regulator.

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

8.4.2 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 4.2 and 8.3). 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 1.1, 4.2 and 8.3).

8.4.3 Selecting the parameters: Treatment time

 Press button [5] to change

the treatment time.

 Change treatment time with

the central regulator.

8.4.4 Parameters instellen: 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.

8.5 Favorites

8.5.1 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”).

8.5.2 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.

8.5.3 Delete favorites

 Press the button “ Favorites”.  First press the ‘Waste bin’

button [8].

 Press the name of the

favorite you wish to delete.

(f.e. my protocol).



The favorite will be deleted

and removes from the list.

9 Maintenance and Troubleshooting

9.1 Maintenance by the user

9.1.1 Cleaning of apparatus

To clean the unit, turn it off and unplug the power supply. Clean the unit with a damp cloth. Do not use

abrasive cleaners. A small amount of mild household detergent may be used, if needed.

9.1.2 Cleaning of the StatUS applicator

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

which could cause fluid to penetrate.

Surface StatUS applicator

To prevent corrosion, clean and dry the contact surface immediately after use. Make sure that no

ultrasound gel remains on the applicator. We recommend cleaning the applicator and cable daily, using

lukewarm water. To disinfect the treatment applicator we advice to use Dismozon® pur. in a solution

between 0,25 and 1,5%. This product can be ordered at Enraf-Nonius under the number 3442438, or with

a cloth moistened with a 70% alcohol solution.

Cable/Rubber Cup

We recommend cleaning the cable and the rubber cup daily with a moist cloth. Use lukewarm water and a

little household cleanser if necessary (no abrasives or no alcohol solutions).

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 (see Figure A). If necessary, you can push up the StatUS applicator a bit from

beneath (see Figure B). Never fold the entire cuff ! (See Figure C.)

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.

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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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