Enraf-Nonius Endopress 442 User manual

Brand: Enraf-Nonius

Model: Endopress 442

Type: User manual

Endopress 442

User Manual

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

Endopress 442

User Manual


 
 
Table of Content 
FOREWORD ........................................................................................................................ 4 
1 This manual ..................................................................................................................... 4 
2 Product Liability .............................................................................................................. 4 
INTENDED USE AND INTENDED USER ............................................................................ 4 
1 The Lymphatic System ................................................................................................... 5 
1.1 Main Groups of lymph nodes of the lower limbs........................................................................ 6 
1.2 General Concepts of lymphatic circulation Casley-Smith Pump ................................................ 6 
1.3 Importance of pressure between Lymphatic and Interstitial space ............................................. 7 
2 Indications ....................................................................................................................... 8 
3 Contra-Indications .......................................................................................................... 8 
IN GENERAL ....................................................................................................................... 8 
INSTALLATION ................................................................................................................... 9 
1 Unpacking ........................................................................................................................ 9 
1.1 Standard accessories: .................................................................................................................. 9 
1.2 Optional accessories .................................................................................................................... 9 
1.3 Environmental conditions for normal use ................................................................................... 9 
2 Electrical Connection ...................................................................................................... 9 
OPERATING INSTRUCTIONS .......................................................................................... 11 
1 Operation Information ................................................................................................... 11 
2 Operation controls front panel ..................................................................................... 11 
3 Operation controls rear panel ...................................................................................... 12 
4 Turn on the apparatus .................................................................................................. 12 
5 Main Menu ..................................................................................................................... 12 
6 Installation and default setting ..................................................................................... 12 
6.1 Default settings ......................................................................................................................... 12 
7 Get Started ..................................................................................................................... 15 
7.1 Select a Program ....................................................................................................................... 15 
8 Pressure Settings .......................................................................................................... 16 
8.1 For an equal pressure in all segments ....................................................................................... 16 
8.2 Individual adjustment per segment ........................................................................................... 17 
8.3 Create personal program Step by Step ...................................................................................... 19 
MAINTENANCE AND TROUBLESHOOTING ................................................................... 22 
1 User maintenance ......................................................................................................... 22 
1.1 Cleaning the garments ............................................................................................................... 22 

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

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

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.

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.

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.

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.

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

1442.912

Endopress 442 – 115VAC

without garments

1442.810

Dummy block

1442.810

Dummy block

1442.751

User Manual English

1442.751

User Manual English

3444.298

EUR - Power cord

3444.611

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.

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.

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

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

11 12

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]

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

• 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.

• 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.

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

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

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

Enraf-Nonius Endopress 442 User manual

Enraf-Nonius Endopress 442 User manual

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