Enraf-Nonius StatUS Pack 100 User manual

Type
User manual
Copyright: 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
www.enraf-nonius.com
Part number: 1629.751_40
January 8, 2015
StatUS
TM
Pack 100
User Manual
2
Contents
1
FOREWORD ...................................................................................................................................... 4
1.1
This manual ....................................................................................................................................... 4
1.2
Product liability ................................................................................................................................. 4
2
PRODUCT DESCRIPTION ................................................................................................................ 4
3
PRECAUTIONARY INSTRUCTIONS ................................................................................................ 5
3.1
WARNING: ......................................................................................................................................... 5
3.2
CAUTION: .......................................................................................................................................... 5
4
INTENDED USE ULTRASOUND THERAPY AND STATUS™ ........................................................ 6
4.1
Ultrasound ......................................................................................................................................... 6
4.1.1
Indications/Contraindications and Adverse Effects for Ultrasound .......................................................... 6
4.1.2
Parameters .............................................................................................................................................. 7
4.2
StatUS Therapy ................................................................................................................................. 7
4.2.1
Duty Cycle Modulation ............................................................................................................................. 8
4.2.2
Amplitude Modulation .............................................................................................................................. 8
5
PACKAGE CONTENTS ..................................................................................................................... 9
5.1
Standard accessories ...................................................................................................................... 9
5.2
Optional accessories ....................................................................................................................... 9
6
INSTALLATION ................................................................................................................................. 9
7
APPLICATION NOTES .................................................................................................................... 10
7.1
Ultrasound (general) ...................................................................................................................... 10
7.1.1
Contact Control ..................................................................................................................................... 10
7.1.2
The contact medium .............................................................................................................................. 10
7.1.3
Before treatment .................................................................................................................................... 10
7.1.4
During treatment .................................................................................................................................... 10
7.1.5
After treatment ....................................................................................................................................... 10
7.2
StatUS™ .......................................................................................................................................... 10
7.2.1
The StatUS™ applicator ........................................................................................................................ 10
7.2.2
Applying the fixation ring ....................................................................................................................... 11
7.2.3
Applying the gelpad ............................................................................................................................... 11
8
OPERATING INSTRUCTIONS ........................................................................................................ 12
8.1
General ............................................................................................................................................ 12
8.1.1
Basic operation ...................................................................................................................................... 12
8.1.2
Main menu ............................................................................................................................................. 12
8.2
StatUS™ Therapy ........................................................................................................................... 12
8.3
Clinical Protocols ........................................................................................................................... 13
8.4
Manual Operation ........................................................................................................................... 15
8.4.1
Setting parameters: frequencies and units ............................................................................................ 15
8.4.2
Selecting the parameters: Duty Cycle modulation ................................................................................. 15
8.4.3
Selecting the parameters: Treatment time ............................................................................................. 16
8.4.4
Selecting the parameters: Intensity ....................................................................................................... 17
3
8.5
Favourites ....................................................................................................................................... 17
8.5.1
Storing protocols ................................................................................................................................... 17
8.5.2
Loading favourites ................................................................................................................................. 18
8.5.3
Delete favourites ................................................................................................................................... 18
9
MAINTENANCE AND TROUBLESHOOTING ................................................................................ 19
9.1
Maintenance by the user ............................................................................................................... 19
9.1.1
Cleaning of apparatus ........................................................................................................................... 19
9.1.2
Cleaning display panel .......................................................................................................................... 19
9.1.3
Cleaning of the StatUS applicator ......................................................................................................... 19
9.2
Troubleshooting ............................................................................................................................. 20
9.2.1
Error code ............................................................................................................................................. 20
9.3
Technical Maintenance .................................................................................................................. 20
9.4
End of life ........................................................................................................................................ 21
10
SPECIFICATIONS ........................................................................................................................... 21
10.1
Ultrasound parameters .................................................................................................................. 21
10.2
Technical data ................................................................................................................................ 21
11
APPENDIX 1 LIBRARY ................................................................................................................... 22
4
1 Foreword
1.1 This manual
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.
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 190 with StatUS™ Pack 100 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 190 please see the Sonopuls
190 user manual. This manual (on CD-ROM; art.no.1631750) is included with the Sonopuls 190.
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 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).
5
3 Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of when using the
StatUS™ Pack 100.
3.1 WARNING:
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.
Do not operate the unit in an environment of short-wave or micro-wave diathermy use as this can
result in burns beneath the electrodes.
Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to
minimize this interference by not using other equipment in conjunction with it.
This device is not suitable for use in the presence of flammable anesthetics mixture with air,
oxygen, or nitrous oxide.
This device should be kept out of the reach of children.
3.2 CAUTION:
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.
Handle the StatUS™ applicator with care. Inappropriate handling of the StatUS applicator may
adversely affect its characteristics.
Inspect the StatUS applicator for cracks which may allow the ingress of conductive fluid before
each use.
Inspect the StatUS™ applicator cables and associated connectors before each use.
Do not operate the StatUS™ Pack 100 when connected to any unit other than Enraf-Nonius BV
devices.
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.
In the case of ingress of liquids, unplug the unit from the mains supply and have it checked by an
authorized person (see the paragraph on technical maintenance).
Before administering any treatment to a patient you should become acquainted with the operating
procedures for each mode of treatment available, as well as the indications, contraindications,
warnings and precautions. Consult other resources for additional information regarding the
application of ultrasound.
Follow the instructions in the user manual.
Read, understand and practice the precautionary and operating instructions.
6
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.
See also chapter 3, 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
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.
Potential Adverse Effects:
Cataracts.
Male sterility.
Enhanced drug activity.
Thermal stress.
7
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
8
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/cm
2
) 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/cm
2).
Both modulations of the Sonopuls 190 with StatUS™ Pack 100 are always switched on* and synchronous
(in phase). This ensures the greatest difference between the minimum and maximum level of the effective
capacity.
* 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).
9
5 Package Contents
StatUS™ Pack 100 (art.nr. 1629901)
5.1 Standard accessories
0169842 Holder for StatUS™ applicator
3442941 Gelpad StatUS™ (240x)
3442942 Fixation ring gelpad StatUS™ (3x)
1629751 User manual StatUS™ Pack 100 (CD-Rom)
1929750 Information Booklet StatUS™ Pack 100
5.2 Optional accessories
3442941 Gelpad StatUS™ (240x)
3442942 Fixation ring gelpad StatUS™ (3x)
6 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, 902 or 903).
To connect the StatUS™ Pack 100 with the Sonopuls 190 please see the "StatUS™ Pack 100
Information Booklet" (1929.751). 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. 8) via the control panel (touchscreen) of the Sonopuls 190.
* = with serial number 07 or higher. Devices with serial number 07 or higher can also be recognised by the picture in
the start screen.
[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.
Connection of accessories other than the ones specified by the manufacturer can adversely
affect the safety of the patient and correct functioning of the equipment, and is therefore not
permitted. For combined applications only use Enraf-Nonius type BF equipment. The very low
leakage current of this type of equipment ensures absolute safe therapy.
10
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.
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.
CAUTION:
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.
11
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.
The gelpads are intended for once-only use. Instructions are supplied with the gel pads. Read these
carefully.
!
Warning
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.
Connection of accessories other than the ones specified by the manufacturer can adversely affect
the safety of the patient and correct functioning of the equipment, and is therefore not permitted.
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.
12
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 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.1631.750) for the Sonopuls 190. This manual (CD-ROM) is
included with the Sonopuls 190.
8.1.2 Main menu
The Sonopuls 190 is equipped with touch screen technology. Via the menu you can 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 (see illustration above). Once a multi-frequency treatment head on channel A is
connected, the function 'Ultrasound Therapy' is clearly visible and accessible.
8.2 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.
13
8.3 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
14
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.
!
! !
!
BE AWARE:
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.
15
8.4 Manual Operation
8.4.1 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.
8.4.2 Selecting the parameters: Duty Cycle modulation
When using StatUS therapy, the Duty Cycle Modulation (as well as the Amplitude Modulation) is always
active (see 4.2). 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.
3
4
5
16
8.4.3 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.
6
17
8.4.4 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.
8.5 Favourites
8.5.1 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.
7
8
18
8.5.2 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.
8.5.3 Delete favourites
Press the button “ Favourites”. First press the Waste bin’
button [9].
Select the number in the
menu that you wish to delete
by using the buttons.
Confirm the selection with
the “OK” button.
You will hear a beep when
the program has been
deleted.
9
19
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 display panel
The display panel contains an anti-reflective coating, which needs special care when cleaned. Use a soft
and dry cotton cloth or micro fibre tissue to clean the panel. To remove fingerprints or grease, use a non-
abrasive glass cleaning agent. Apply a small amount of the cleaning agent to a soft cotton cloth and then
carefully clean the panel.
CAUTION:
Do not spray the cleaning agent directly on the glass panel.
Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or
detergents with ammonia.
9.1.3 Cleaning of the StatUS applicator
General
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).
Attention
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.)
20
Note:
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.
Figure A
Figure B Figure C
9.2 Troubleshooting
9.2.1 Error code
When the apparatus is turned on, it will first execute a self test. When an error is detected, both during the
self test and during normal operation, a pop-up screen will appear on the display. When the error is
displayed, all outputs will be disabled. When this situation occurs, remove all cables and switch the
apparatus off and on again. When the error re-appears, stop using the device and contact your supplier.
9.3 Technical Maintenance
On request a service manual can be made available containing: spare part list, descriptions, calibration
instructions and other information which will assist the user’s appropriately qualified technical personnel
to repair those parts of the equipment which are designated by the manufacturer as repairable.
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28

Enraf-Nonius StatUS Pack 100 User manual

Type
User manual

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI