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.
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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.
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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.
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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
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• 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.
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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
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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
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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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