Enraf-Nonius Endopress 442 User manual

Type
User manual
Endopress 442
User Manual
Copyright:
Enraf-Nonius BV
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: 1442751-43
October 11,2017
1
Endopress 442
User Manual
2
Table of Content
1 FOREWORD ........................................................................................................................ 4
1.1 This manual ..................................................................................................................... 4
1.2 Product Liability .............................................................................................................. 4
2 INTENDED USE AND INTENDED USER ............................................................................ 4
2.1 The Lymphatic System ................................................................................................... 5
2.1.1 Main Groups of lymph nodes of the lower limbs........................................................................ 6
2.1.2 General Concepts of lymphatic circulation Casley-Smith Pump ................................................ 6
2.1.3 Importance of pressure between Lymphatic and Interstitial space ............................................. 7
2.2 Indications ....................................................................................................................... 8
2.3 Contra-Indications .......................................................................................................... 8
3 IN GENERAL ....................................................................................................................... 8
4 INSTALLATION ................................................................................................................... 9
4.1 Unpacking ........................................................................................................................ 9
4.1.1 Standard accessories: .................................................................................................................. 9
4.1.2 Optional accessories .................................................................................................................... 9
4.1.3 Environmental conditions for normal use ................................................................................... 9
4.2 Electrical Connection ...................................................................................................... 9
5 OPERATING INSTRUCTIONS .......................................................................................... 11
5.1 Operation Information ................................................................................................... 11
5.2 Operation controls front panel ..................................................................................... 11
5.3 Operation controls rear panel ...................................................................................... 12
5.4 Turn on the apparatus .................................................................................................. 12
5.5 Main Menu ..................................................................................................................... 12
5.6 Installation and default setting ..................................................................................... 12
5.6.1 Default settings ......................................................................................................................... 12
5.7 Get Started ..................................................................................................................... 15
5.7.1 Select a Program ....................................................................................................................... 15
5.8 Pressure Settings .......................................................................................................... 16
5.8.1 For an equal pressure in all segments ....................................................................................... 16
5.8.2 Individual adjustment per segment ........................................................................................... 17
5.8.3 Create personal program Step by Step ...................................................................................... 19
6 MAINTENANCE AND TROUBLESHOOTING ................................................................... 22
6.1 User maintenance ......................................................................................................... 22
6.1.1 Cleaning the garments ............................................................................................................... 22
3
6.1.2 Cleaning the apparatus ............................................................................................................. 22
6.2 End of life ...................................................................................................................... 22
7 TROUBLESHOOTING ....................................................................................................... 23
7.1.1 Checklist ................................................................................................................................... 23
8 ELECTROMAGNETIC INTERFERENCE .......................................................................... 24
8.1 Electromagnetic Interference ....................................................................................... 24
9 TECHNICAL SPECIFICATIONS........................................................................................ 24
10 APPENDIX 1 .................................................................................................................. 25
10.1 Basic protocols ............................................................................................................. 25
11 DESCRIPTION-SYMBOLS USED AND DEVICE MARKINGS ....................................... 27
12 EMC TABLE ................................................................................................................... 28
4
1 Foreword
1.1 This manual
This manual has been written for the owners and operators of the Endopress 442. 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.
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.
Enraf-Nonius cannot be held liable for any consequence resulting from incorrect information
provided by its personnel, or errors incorporated in this manual and / or other accompanying
documentation (including commercial documentation)
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 Intended Use and Intended User
The Endopress 442 is a unit for compression therapy. The Endopress 442 system works with
pneumatic leg and arm garments for a non-invasion treatment of lymph edema, insufficiencies
of the veins, and some chronic not-healing wounds and ulcers.
The segments of the garments fill up with air whereby the compression rises in the arm
or leg to the adjusted pressure.
Only qualified personnel should operate Endopress 442. This is to ensure proper use and
complete safety for the patient
5
2.1 The Lymphatic System
A basic function of the lymphatic system is to supervise the maintenance of correct water tissue
balance: this action is conducted on the lymph in order to purify it from the substances
“collected” by it on the outside, and then send it back into circulation ready to perform its
functions.
This action tends to develop in places where excessive “liquid stagnation” in tissues is signalled
for various reasons.
The lymphatic system is structurally similar to the more well-known venous system. It actually
follows it branching out into peripheral channels and collection “centres” distributed at various
levels.
The surface lymph vessels differ from the deeper ones in the lower limbs.
The surface vessels run along the surface and give origin to a rich lymphatic network distributed
on the plantar and dorsal surfaces of the feet. The deeper vessels accompany the deep blood
vessels and collect the lymph that comes from the muscles and the bones of the lower limbs.
The surface lymph vessels converge in the inguinal lymph nodes that are at the surface in the
fold of the groin area.
Points of highest concentration of lymph nodes
(Elbows, knees and along the collar are slightly less).
The arrows show the direction of lymph flow.
The deep lymphatics meet the anterior tibial lymph nodes along their path, situated in the higher,
anterior part of the leg, and the lymph nodes of the popliteal cavity (4-5 in number), situated on the
posterior face of the knee. They then reach the deep inguinal lymph nodes that are located deep in
the inguinal area.
In addition to the superficial lymph vessels of the lower limb, the surface inguinal lymph nodes (18-
20 in number) collect the lymphatics of the buttocks, perineum, the anus, the external genital organs,
and lower part of the abdomen. In addition to the deep popliteal lymphatic vessels, the deep inguinal
lymph nodes (2-3 in number) mostly collect what comes from the surface inguinal lymph nodes.
The largest of these lymph nodes is called the Cloquet lymph node and is located higher up and
deeper down than the others, extruding therefore into the abdominal cavity.
6
2.1.1 Main Groups of lymph nodes of the lower limbs
These lymph node centres of the lower limbs are very important in the functioning of the whole
system, as they act as collection tanks, and also purify the lymph coming from the lower limbs. The
lymph stays in these centres as long as necessary to be filtered, i.e. purified, and is then poured
back into the renal system with increase of diuresis. This increase of the diuresis is often
encountered after therapy with pressure systems (massage pressure therapy) and confirms
activation of the lymphatic system mechanisms in the lower limb tissues.
2.1.2 General Concepts of lymphatic circulation Casley-Smith Pump
Lymphatic circulation is not just a system that intervenes in cases of “over fullness” but also permits
the rapid absorption of proteins and colloids.
Thanks to the lymphatic system, large or insoluble plasmatic protein molecules that cannot normally
be reabsorbed by the venous system are reintroduced into the blood circulation.
The molecules pass the capillary membrane in a manner that is inversely proportional to their
weight: the amount of albumin is higher in lymph, which has a lower molecular weight than globulin.
Of course variations of the capillary permeability caused by increase in intercapillary hydrostatic
pressure or toxic-anoxic factors for example, mean that there is an increase in that transfer, in a
modification of the lymph flow or its composition.
For further clarification, we provide Rossing’s findings on the matter:
1. the intravascular masses of albumin and immunoglobulin depend on the amount of synthesis
and the amount of fractionated catabolism;
2. The ratios of intravascular masses to the total masses depend on the amount of
transcapillary escape and on the amount of extravascular return;
3. the amount of transcapillary escapes are inversely related to the molecular weights of the
proteins; the amount of transcapillary escape increases with the filtration pressure in the
vessels, i.e. with the loss at microvessel level, as seen in diabetes mellitus;
4. the amount of extravascular return reflects the lymphatic protein transport and is inverse to
the extravascular transit time. It is of the same magnitude for albumin and lg.G and perhaps
a bit less for lg.M;
5. the extravascular transit time includes a wide series of transit times: short (liver, kidneys,
lungs), long (skin, muscles, with maximum deposit of extravascular proteins);
6. in most cases of hypoproteinemia, the amount of intravascular/extravascular plasmatic
protein distribution changes in favour of the intravascular space;
7. the extravascular pathological build-up of plasmatic protein occurs in a few diseases, and
when the transcapillary escape increases without a corresponding increase in the amount of
lymphatic return. This can be seen in cirrhosis with ascites, in untreated myxoedema and in
some types of cancer, particularly those with hepatopathy and ascites. If anything, the
extravascular build-up of plasmatic protein will occur in the tumoral and post-operative tissue
in the wounds.
The main function of the lymphatic system is therefore to allow its penetration by the previously
mentioned molecules, prevent escape, and encourage progression.
By way of the capillary filtration, protein molecules and water are plentiful in blood circulation,
thus causing a build-up of liquids osmotically linked to the protein in the interstitial tissue.
The liquid leads to an imbibition of the tissue, stretching the endothelial cells of the initial
lymphatics and further opening the lymphatic interendothelial junctions.
Other movements intervene in keeping the junctions “open”:
muscular movement;
rhythmic contractions of the arterial vessels
the negative interthoracic pressure;
the cells and any other elementary corpuscles that are pushed through the open
junctions in the initial lymphatics.
7
During their transit, these corpuscles act like dilators, keeping the passage free through the
junction of the initial capillary lumen. In the most active areas of the body, the products of
cellular metabolism increase blood flow and the capillary permeability, so liquid contained in the
interstitial tissue increases further, and its pressure keeps the input routes accessible to the
lymphatic capillaries.
An increase in local tissue pressure follows this initial stage, caused by muscular contraction
that compresses the initial lymphatics, and therefore pushing the lymph to close the intercellular
junctions. In this phase, a certain quantity of water spreads out from the lymphatics and the
lymph itself becomes more concentrated than the interstitial liquid.
The higher compression releases the system from fibrils attached to the lymphatic endothelium.
The lymphatics that have been compressed like this will obviously be smaller with lower
diameters, being adhesive endothelial cells and therefore overlapping with the junctions
hermetically closed.
At this point, the third phase begins: a further compression on the initial lymphatics pushes the
lymph through the first valve, the sudden lowering of pressure means that the lymphatics
expand again, and the intercellular junctions open up again.
This mechanism is called the “CASLEY-SMITH lymphatic pushing pump”. Intercellular lymphatic
junctions have been defined as “aspiration valves” while the first lymphatic valve is known as
the “escape valve”.
The initial lymphatics comprise several aspirations and pushing pumps whose function is not
strictly mechanical but can be adapted to different needs.
2.1.3 Importance of pressure between Lymphatic and Interstitial space
Mc Master measured the pressure values both of lymphatic capillaries, and of the interstitial
space, finding:
Lymphatic capillary pressure = 0.7 +/- 0.3 cm. H2O.
Interstitial space pressure = 1.9 +/- 0.5 cm. H2O.
This pressure difference explains the direction of liquid flow and of the protein molecules of the
blood capillaries to the interstitial tissue, and of the interstitial tissue to the lymphatic capillaries.
The difference found (0.3 +/- 0.5 cm. H2O), clearly shows how much pressure variation is
needed to start up the lymph. In pathological conditions, if there is an increase in interstitial
pressure, the difference will be higher. This explains the increase in production of lymph in the
presence of oedema. The variation in absorption potential also holds importance at the frontier-
zone between the basic substance and the lymphatic capillary.
The propulsion of lymph is therefore mainly due to the gradient generated between a zone of
higher pressure and a zone of lower pressure. For the entire lymphatic cycle, many other
mechanisms contribute to the progression of lymph, that carry greater or lesser importance (as
previously mentioned). Among these are the structures of the lymphatic vessel walls and the
unidirectional valves which are also antigravitational mechanisms (with the lymph nodes).
The speed of progression of the lymph varies widely according to the various zones, the
functional situation, and according to whether there are any obstacles to normal flow.
8
2.2 Indications
Hromboembolic prophylaxis
Post-thrombothic syndrome
Ulcus cruris
Venous oedema
Post-traumatic oedema
minor lymphatic oedema
Lipoedema
Mixed forms of oedema
Peripheral arterial occlusive disease under strict observation
Sensory disturbance caused by hemiplegia
2.3 Contra-Indications
Decompensated cardiac insufficiency
Extensive thrombophlebitis, thrombosis or suspected thrombosis erysipelas
severe unstabilised hypertension
Acute soft-part-trauma of extremities
Neuropathy occlusive processes in the sector of lymphatic drainage
3 In General
Enraf-Nonius BV. develops and manufactures equipment and accessories according to the
highest standards of quality making use of the latest technology and fully adhering to current
directives and norms.
Particular attention has been paid to the design, easy operation, function and safety of the
equipment and the final result is this modern, compact unit, which offers an extremely logical
operative sequence supported by a clearly legible display. A wide range of therapeutic
applications guaranteed patient and therapist safety make, the Endopress 442 of the highest
quality.
9
4 Installation
4.1 Unpacking
Endopress 442 is specially packaged for transport in a single pack complete with filling which
has been specifically studied for safe transportation and storage.
To remove the unit from the packaging, place the box on a smooth, flat surface. Open the top
of the box and remove the polystyrene filling.
Be very careful when removing the contents of the pack.
Check the contents of the package and should any of the items be missing then contact your
local authorized Enraf-Nonius BV. dealer
4.1.1 Standard accessories:
1442.911
Endopress 442 230VAC,
without garments
Endopress 442 115VAC
without garments
1442.810
Dummy block
Dummy block
1442.751
User Manual English
User Manual English
3444.298
EUR - Power cord
UL-CSA - Power cord
4.1.2 Optional accessories
Model
1442.800
Nine-segment lower limb garment
1442.801
Seven-segment arm garment
Save the original box and all the packing materials in case of return to manufacturer or your
dealer.
WARNING
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
4.1.3 Environmental conditions for normal use
Installation of the equipment is fast and simple and does not require any particular attention.
The following environmental conditions are ideal when installing the unit:
Room temperature : 10°C to 40°C
Humidity level : 10% to 80% non condensing
Atmospheric pressure : 500 to 1060 hPa
Avoid direct exposure to sunlight, chemical products and vibrations.
CAUTION
Do not use the Endopress 442 wherever there is a risk of either the external or internal parts of
the unit becoming wet.
4.2 Electrical Connection
The power entry module can be found on the back of the unit and consists of a three-pole
socket for the cord set, an extractible fuse box with two fuses (see Technical specifications) and
the main switch.
Insert correctly the three-pole plug of the cord set into the power entry module.
10
WARNINGS
Before plugging the cord set into the mains, check to make sure the equipment has not
undergone any damage during transport and make sure the voltage corresponds to that of
the unit (see the rating plate on bottom of the unit).
For safety purposes the cord set is provided with an earthed plug.
Make sure that power supply socket has been earthed.
The equipment must only be connected to the mains which are in conformity with EEC
standard directives.
When using an extension lead, make sure that this has been earthed
Failure to comply with the above instructions may lead to dangerous electrical discharge
causing hazard to persons and the machine function.
11
5 Operating Instructions
The Endopress 442 unit has a well-engineered control panel.
All working parameters are handled and controlled in real time by a sophisticated
microprocessor electronic circuit which clearly displays its functions accompanied by acoustic
signalling.
5.1 Operation Information
This chapter provides important information and instructions on how to make correct use of the
Endopress 442.
All the control functions and the machine itself are handled and coordinated by a
microprocessor: apart from making available pre-memorized programmes for application the
microprocessor ensures that the machine can be personalized and operate in a highly safe and
efficient manner. Interfacing allows for the operator to dialogue with the apparatus by means of
large, clear graphic backlit liquid crystal display screen (LCD): all the information for operation
required by the operator, work status during operation and any eventual errors are visualized.
The following paragraphs illustrate the procedures to be carried out and the technical
specifications of the Endopress 442. They also deal with the different options available from the
selection of pre-programmed protocols for use in specific treatments as well as how to
determine the correct working parameters for “personalized” application.
5.2 Operation controls front panel
The front panel of the unit, which comprises the controls and signals, can be seen in fig. 1 with
corresponding key.
[1] Selection button 1
[2] Selection button 2
[3] Selection button 3
[4] Selection button 4
[5] Display
[6] Start button
[7] Stop button
[8] Confirmation button
[9] Central controller
1
23
4
6
8
7
9
5
12
5.3 Operation controls rear panel
The rear panel contains the power entry module which consists of the main switch, the fuse box
and the socket for the cord set.
[10] On/Off switch
[11] Garment connector 1
[12] Garment connector 2
[13] Connection power cord
10
11 12
13
5.4 Turn on the apparatus
Plug the power cord on socket [13]
Use switch [10] to turn the apparatus on.
The unit starts-up with the logo on the display.
Push any button to activate the main menu.
5.5 Main Menu
ENDOPRESS 442
1
3
2
Load Program
Settings
4
5.6 Installation and default setting
5.6.1 Default settings
This enables the basic settings to be memorized and stored within the machine memory and will
automatically be displayed each time the machine is turned on.
5.6.1.1 Select Language
ENDOPRESS 442
1
3
2
Load Program
Settings
4
Select “Settings” with the push button [4]
13
Display
Various
Language
Version: 1.00.00
1
3
2
Exit
4
Choose Language function with the central controller [9]
Press the confirmation button [8] to confirm choice.
Italiano
English
Français
Español
Nederlands
Deutsch
1
3
2
Cancel
4
Select the desired language with the central controller [9]
Press the confirmation button [8] to activate the language
5.6.1.2 Display settings
Display
Various
Language
Version: 1.00.00
1
3
2
Exit
4
Select Display with the central controller [9] and confirm with button [8]
Contrast : 30
Brightness : 30
Inverted : OFF
1
3
2

Save
Exit
4
14
Choose one item from the list with the central controller [9]
Change the setting with central controller [9]
Press the confirmation button [8] to activate choice
Press save button [1] to save the setting
Push the Exit button [4] to return to the main menu
5.6.1.3 Various settings
ENDOPRESS 442
1
3
2
Load Program
Settings
4
Select “Settings” with the push button [4]
Display
Various
Language
Version: 1.00.00
1
3
2
Exit
4
Choose Various with the central controller [9]
Press the confirmation button [8] to confirm choice.
Beep : ON
Pitch Beep : 1
Free Memory space : 98%
Delete memory
1
3
2

Save
Exit
4
Select one item with the central controller [9] and follow the instructions on the screen.
o Beep: to add a beep on every push at a button.
o Pitch Beep: Select here the tone frequency of the beep
o Free memory space: Gives information about the free memory space
o Delete memory: Here you can clear the whole memory.
CAUTION
o It’s not possible to delete only one single program position by formatting the
system, you delete all programmed programs at ones.
o The pre-programmed protocols cannot be deleted.
15
Push the Save button [2] to store the settings and to return to the previous menu.
To cancel push the button [4]
5.7 Get Started
5.7.1 Select a Program
There are several programs for leg -and arm garments. See appendix 1
ENDOPRESS 442
1
3
2
Load Program
Settings
4
Push the button [2] to Load Program. In this menu you can select:
o Pre-programmed protocols. See appendix 1 for detailed information.
o The personal programs via User memory
01 THROMBOEMBOLIC PROPHYLAXIS
02 POST-THROMBOTIC SYNDROME
03 ULCUS CRURIS
04 VENOUS OEDEMA
1
Protocols
3
2
User Memory
Exit
4
Select a protocol with the central controller [9]
Push the confirmation button [8] to select the protocol
Adjust the pressure in the garment (see paragraph 5.8)
01 THROMBOEMBOLIC PROPHYLAXIS
Time: 25 min
Preview
1
Modify
Save
3
2
Pressure
Exit
4
Push the green start button [6] to start the treatment or use the modify button [1] to
change the treatment time.
16
01 THROMBOEMBOLIC PROPHYLAXIS
Time: 25 min
1
3
2
Pressure
4
5.8 Pressure Settings
The Endopress 442 guarantees the full control of the pressure applied. It allows the operator to set
different maximum pressure values for each cell, or the “Overall” setting can be used to set the same
value for all segments.
These values will be defined by the operator by examining the patient’s medical history and making
an objective analysis.
There are two different pressures settings for the protocols;
The gradient method whereby the garment is divided in 3 zones.
o Zone 1 - 100% , Zone 2 - 80%, Zone 3 - 60%
The linear method whereby the pressure equal is in all cells. (100%)
Gradient method
Linear method
5.8.1 For an equal pressure in all segments
Push the selection button [2]
Push the confirmation button [8] to change the Overall pressure
Change the value with the central controller [9]
Push the confirmation button [2] again
Push the Save button [2] to store the setting
17
01 THROMBOEMBOLIC PROPHYLAXIS
Time: 25 min
Preview
1
Modify
Save
3
2
Pressure
Exit
4
Overall: 80 mmHg
Press. 5: 80%
Press. 1: 100%
Press. 6: 80%
Press. 2: 100%
Press. 7: 60%
Press. 3: 100%
Press. 8: 60%
1
Press. 4: 80%
Press. 9: 60%
3
2

Save
Cancel
4
5.8.2 Individual adjustment per segment
Select a segment in the list with the central controller [9].
Push the confirmation button [8]
Change the value with the central controller [9]
Push the confirmation button [8] and select another segment with the central controller [9]
Repeat this for all other segments.
Push the save button to store the settings
CAUTION
Pressure therapy must be carried out by applying the correct pressure fields and not
interfering with the physiology of arterial, venous or lymphatic circulation (which is why
the arms and legs are constructed in a herringbone structure with partially overlapping
sectors). The maximum level of pressure applied to the patient is also a very important
parameter. In certain cases this value must be kept very low (for example if the pressure
therapy is used for physiological massage on patients for whom other types of active or
passive movement is impractical). The value can be higher in other applications such as
anti-cellulite applications.
The Endopress can supply a maximum pressure of 150 mmHg per segment. Treatments
are normally carried out between pressures of 40 and 80 mmHg. Higher pressures can
only be used in special cases under strict medical supervision.
The operator should limit the pressure applied in order to avoid opposing arterial flow
18
5.8.2.1 Pause Stop the treatment
Push, during the treatment, the stop button [7] ones to pause the program
Push the green start button [6] to continue the treatment
01 THROMBOEMBOLIC PROPHYLAXIS
PROGRAM IS
INTERRUPTED
1
3
2
Set. pressure
4
Push the stop button again to stop the treatment and to start the deflation of the
garment.
Push the stop button again to stop the treatment and to start the deflation of the
garment.
01 THROMBOEMBOLIC PROPHYLAXIS
PROGRAM
HAS ENDED
1
3
2
Set. pressure
4
5.8.2.2 Treatment time
01 THROMBOEMBOLIC PROPHYLAXIS
Time: 25 min
Preview
1
Modify
Save
3
2
Pressure 80 mmHg
Exit
4
Push the Modify button [1] and select Time with the central controller [9]
Confirm with the confirmation button [8] and change the time with the central controller
[9]. Push the confirmation button [8] to confirm.
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Enraf-Nonius Endopress 442 User manual

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