USER MANUAL

eva sp® 7

Version 2.7 of 19th June 2018

 User manual eva sp® 7

Table of Contents
1 IMPORTANT SAFETY NOTES FOR THE USE OF THE EVA SP® 7 DEVICE .................. 5
2 IMPORTANT NOTES FOR THE EVA SP® 7 USERS ............................................................. 8
2.1 WARNING ...........................................................................................................................................8
2.2 PRECAUTIONS ..................................................................................................................................8
3 DESCRIPTION .............................................................................................................................. 9
3.1 EXPLANATION ..................................................................................................................................9
3.2 CHARACTERISTICS .........................................................................................................................9
4 LOGO ............................................................................................................................................... 9
5 LABELLING ................................................................................................................................. 10
6 EVA SP® 7 DESCRIPTION AND ASSEMBLY INSTRUCTIONS......................................... 11
6.1 DESCRIPTION OF THE EVA SP® 7 FRONT PANEL ......................................................................... 11
6.2 DESCRIPTION OF THE EVA SP® 7 REAR PANEL .............................................................................. 12
6.3 EVA SP® 7 ASSEMBLY INSTRUCTIONS ............................................................................................. 13
6.4 ASSEMBLY INSTRUCTIONS AND DESCRIPTION OF THE FAT HARVESTING CONTAINER ................. 15
6.4.1 Assembly instructions ................................................................................................................... 15
6.4.2 fat discharge tubING ..................................................................................................................... 16
6.4.3 Medi-vac canister and MEDI-VAC BAG ................................................................................. 16
7 DESCRIPTION OF THE EVA SP® 7 FUNCTIONING ........................................................... 18
7.1 START-UP ............................................................................................................................................ 18
7.2 LANGUAGE SELECTION ....................................................................................................................... 19
7.3 PATIENT FILE...................................................................................................................................... 19
8 NOTES........................................................................................................................................... 22
9 INFILTRATION........................................................................................................................... 23
9.1 INSTALLATION OF THE SYRINGES AND THE INFILTRATION KIT .................................................. 24
9.2 CONNECT THE INFILTRATION KIT TUBING ....................................................................................... 29
9.3 INFILTRATION CYCLE ......................................................................................................................... 31
10 SUCTION .................................................................................................................................. 33
11 “SNAPSHOT” AND "CONTINUOUS” MODE .................................................................... 34
11.1 SNAPSHOT MODE ........................................................................................................................... 34
11.2 CONTINUOUS MODE ...................................................................................................................... 34
12 SERVICING, STORAGE AND MAINTENANCE OF THE EVA SP® 7............................ 35
12.1 SERVICING ...................................................................................................................................... 35
12.2 STORAGE ............................................................................................................................................. 37
12.3 MAINTENANCE ................................................................................................................................... 37
12.4 POSSIBLE FAILURES ......................................................................................................................... 39
12.5 TECHNICAL CHARACTERISTICS OF THE ASPIRATOR ........................................................................ 39
12.6 FAT IN THE EVA SP®7 ...................................................................................................................... 39
13 LIST OF ACCESSORIES FOR THE EVA SP® 7 ................................................................. 41
14 CONTACT OUR TECHNICAL DEPARTMENT ................................................................. 42
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 User manual eva sp® 7
15 CANNULAS .............................................................................................................................. 42
16 LIPOMATIC / EVAMATIC ................................................................................................... 42
17 INDICATIONS – PURPOSES ................................................................................................ 43
19 CONTRAINDICATIONS ............................................................................................................... 43
20 STUDIES ON THE N.I.L. TECHNIQUE® — REFERENCES ............................................ 44
21 WARRANTY CERTIFICATE ....................................................................................................... 45
22 SATISFACTION SURVEY ..................................................................................................... 46

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 User manual eva sp® 7

Foreword
The eva sp® 7 completes the Lipomatic® / evamatic® range of products.
The eva sp® 7 combines, in a single casing, various functions for infiltration and
aspiration using the N.I.L.1® technique.
This device is used to infiltrate the fatty tissues with physiological fluid before a
liposuction but it can also be used independently from the other devices
manufactured by Euromi S.A.

1 Nutational Infrasonic Liposculpture

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 User manual eva sp® 7

1 IMPORTANT SAFETY NOTES FOR THE USE OF THE EVA sp® 7

DEVICE

 Any use of the device outside of its intended use described in this manual is
not the responsibility of Euromi S.A.

 The eva sp® 7 is a Class IIa product according to the Medical Devices
Directive (93/42/EEC).

 Using accessories OTHER than those supplied by Euromi S.A. is the

responsibility of the user. Unauthorized accessories do not comply with the
quality requirements of the eva sp® 7. In addition, using these unauthorized
accessories can be dangerous and may compromise the safety of both the
user and the patient.

 Never open the casing. Repairs or maintenance of the eva sp® 7 must only be
carried out by the Technical Department of Euromi S.A. or by a technician
authorized by Euromi S.A. It is highly recommended to perform the
maintenance once a year.

 Tubing kits are sterile and single-use. Change the tubing kit before each
operation. Each used tubing kit must be discarded.

 Before each operation, sterilize all reusable components of the device (the
Lipomatic® / evamatic® handpiece, tightening tool and cannulas) and
replace all disposable components.

 Using an air source that does not provide medical air is the responsibility of
the user.

 This device is designed to operate at a room temperature of 0–40°C and in a

relative humidity of 40–70% (ideally, it should be used in an operating
theatre). Do not use the device in a hazardous environment (risk of
explosion, etc.).

 Ideally, the eva sp® 7 should be used at an atmospheric pressure of 950–

1050 kPa.

 This symbol indicates that the instructions for use must be read
before using the device.

 CE conformity marking and notified body number.

 For safety reasons, the socket to which the device is connected must be fitted
with an earth connection according to regulations.

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 User manual eva sp® 7
 This device is designed for a 200/240V∼ 50/60Hz supply voltage with a
maximum power rating of 3.17A or a 100/115V∼ 50/60Hz supply voltage
with a maximum power rating of 6.35A.

 If a fuse fails, always use a replacement fuse of the same value, intensity and
type. Never bridge a defective fuse.

 The eva sp® 7 has a 10-year service life providing that the maintenance is
done annually. This service life has been determined based on the service
life of the components and their replacement at a reasonable price. Using the
eva sp® 7 during more than 10 years is the responsibility of the user.

 The treatment, collection, recycling and disposal or decommissioning of the

device and electrical and electronic equipment must be performed in
accordance with current national legislation.

 The eva sp® 7 meets the requirements of the Medical Devices Directive
93/42/EC and the standard for electromagnetic compatibility of medical
electrical equipment IEC 60601-1. However, the risk of magnetic disturbance
to a nearby device cannot be excluded if it does not meet the current
standards.

 The EVA sp® 7 device shouldn’t be touched by the patient and must be
placed at minimum 1.5 meters from him/her. This distance between the
patient and the device is mandatory. Only a non-sterile person who is not in
contact with the patient can control the eva sp® 7 during an operation.

 The classification of the device depending on the level of protection against

water entry is rated IPX0.

 No electrical parts should be in direct contact with the patient.

 Any modification of the eva sp® 7 is strictly prohibited.

 The eva sp® 7 can operate continuously for a period of 8 hours.

 The eva sp® 7 device can only be sold to qualified doctors or surgeons who
received a specific and adequate training given by the Euromi S.A. company
or a person (technician or sales person) approved by it and who have read
the user manual carefully.

 Anyone using the device must follow a specific training given by a person
(technician or sales person) approved by Euromi S.A. and can ask for an
additional training if needed by contacting the Euromi company. Each
training
must be given either at the Euromi S.A. company during a workshop, either at
the hospital where the device is used.

 The eva sp® 7 can only be used by medical professionals and the physician
using this device is responsible for selecting the physiological fluid.
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 User manual eva sp® 7

 When the eva sp® 7 is turned off, the air contained in the device is vented out.

 The eva sp® 7 is a class I medical device that provides a protection against
electric shock.

 The eva sp® 7 device should be used in operating rooms only, in zones
where flammable anaesthetics are used. Explosion hazards can exist if
anaesthetics are mixed with air or oxygen.

 Any use other than that specified in this manual is strictly prohibited.

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2 IMPORTANT NOTES FOR THE EVA SP® 7 USERS

2.1 WARNING
 The device itself does not result in significant weight reduction.

 It should be used with extreme caution on patients suffering from chronic diseases
such as diabetes, cardiovascular diseases, lung diseases or obesity.

 The lost quantity of blood and endogenous body fluid can affect the hemodynamic
stability intra and/or post-operative as well as endanger the patient safety. To
preserve the patient safety, it is essential to compensate this loss in an adequate and
timely manner.

2.2 PRECAUTIONS
 This device is designed for body sculpting, removing localized fat deposits through
small incisions.

 The use of this device is limited to physicians or surgeons who, according to

professional training programmes or authorized continuous medical training
(including supervised operative experience), have reached the required level of
competence in lipoplasty.

The eva sp® 7 can only be used by medical professionals who have followed a
training and have read the user manual carefully.

The results of this procedure can be permanent or temporary and can vary
depending on the age of the patient, on the parts of the body being operated on as
well as on the experience of the surgeon.

The volume of fat removed should be limited to what is necessary in order to obtain the
desired aesthetic or therapeutic effect.

Before each operation, sterilize all reusable components of the device and replace all
disposable components.

Any use of the device outside of its intended use described in this manual is not the
responsibility of Euromi S.A.

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 User manual eva sp® 7

3 DESCRIPTION
3.1 EXPLANATION
The eva sp® 7 is a non-sterile device used to infiltrate, prior to liposuction, infiltration
liquid previously prepared by the user into the fat tissue.
The eva sp® 7 is used for cosmetic and/or therapeutic purposes (see section 18
INDICATIONS – PURPOSES).

It is designed to complete the Lipomatic® / evamatic® range of products. Nevertheless,

the eva sp® 7 can also be used independently from the other devices manufactured by
Euromi S.A.

The eva sp® 7 combines, in a single casing, various functions for infiltration and
aspiration using the N.I.L.2® technique.

This device should be installed vertically on its four wheels and on a flat surface.

3.2 CHARACTERISTICS
 Indication of the quantity of fluid infiltrated per area on a 15“ touch screen
 Digital touch screen providing access to various system controls
 Four operating modes: Infiltration / Suction and snapshot / Continuous
 Physiologic serum (saline solution) bag, connected to the infiltration tubing kit
 Compact control panel
 Easily transportable
 Improvement of the working environment
 Noise reduction
 Overpressure control

4 LOGO

Non-ionizing radiation

2 Nutational Infrasonic Liposculpture

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 User manual eva sp® 7

5 LABELLING

Please note that the label differs depending on the type of voltage used.
200/240V∼ version:

100/115V∼ version :

Manufacturer

Please read the user manual carefully before using the device

Device serial number

Reference

Fuse

Notified body number

Precautions to be taken

Product should be discarded at a suitable recovery and recycling facility

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6 EVA SP® 7 DESCRIPTION AND ASSEMBLY INSTRUCTIONS

6.1 DESCRIPTION OF THE EVA SP® 7 FRONT PANEL
The front panel includes:

1. Control panel:
a. Infiltration / Suction
b. Snapshot / Continuous
2. Connectors for air tubing
3. Syringes for infiltration
4. MEDI-VAC bags and canisters
5. Infiltration bags
6. Pedal connectors
7. Connectors to connect
the MEDI-VAC canister to the
aspirator

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 User manual eva sp® 7
6.2 DESCRIPTION OF THE EVA SP® 7 REAR PANEL

1. ON/OFF power switch to turn on (symbol “I”) and turn off the device (symbol “O”).
2. Power supply of 200/240V∼ or 100/115V∼.
3. Two fuses (of 4A for power supply of 200/240V∼ or of 8A for power supply of
100/115V∼).
4. AIR SOURCE connection (max. 10 bars, min. 5 bars) supplying the eva sp® 7 with
compressed air.
5. “SPEED INFILTRATION” button controlling the infiltration speed.
6. A small valve is located at the rear panel of the device, bottom left. It is used to
drain oil from the silencer oil trap. Open it once a month to drain the oil.

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6.3 EVA SP® 7 ASSEMBLY INSTRUCTIONS

 Connect the electrical power cord supplied by Euromi S.A. with the eva sp® 7 to the
power socket (see item 2 of the picture in paragraph 7.2).

 Connect the compressed air supply (max. 10 bars, min. 5 bars) to the AIR SOURCE
socket using the braided hose supplied by Euromi S.A. with the eva sp® 7.
The air can be supplied from a wall socket, an air cylinder or a compressor.

Warning: Before removing the eva sp® 7 air hoses, disconnect the air from its source. To
remove the hose, first press the blue ring and, while keeping it pressed, remove the hose.

 Install and secure the serum holder by inserting the rod vertically in the hole on the
top cover.

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 User manual eva sp® 7
 Connect the two pneumatic pedals to the connectors on the bottom of the eva sp® 7
(see item 6 of the picture, paragraph 7.1).

Warning : To remove the tube of the pedal input, first press the blue ring and, while
keeping it pressed, remove the hose.

 Connect the Lipomatic®/evamatic® double AIR tubing to both the IN and the OUT
connectors (see item 2 of the picture, paragraph 7.1).
 The small tubing goes into the “IN’” connector (air inlet).
 The large tubing goes into the “OUT” connector (air outlet).

Tubings are delivered sterile and can only be unpacked in operating rooms.

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 User manual eva sp® 7
6.4 ASSEMBLY INSTRUCTIONS AND DESCRIPTION OF THE FAT HARVESTING
CONTAINER

6.4.1 ASSEMBLY INSTRUCTIONS

 Attach the canister holder using the mounting bracket on the eva sp® 7 side rail
provided for this purpose.
 Place the MEDI-VAC bag canister inside the MEDI-VAC canister.
 Connect the white silicone tube to the valve connector located under the mounting
bracket (see item A on the picture above).
Make sure to push the tube deep enough into the connector.
 Connect the end of the red tube from the connector of the canister holder located
on the mounting bracket (see item B on the picture above) to the “VACUUM”
connector on the MEDI-VAC bag canister inside the MEDI-VAC canister. This bag
has a filter that prevents fat to rise upwards towards the pump (see item C on the
picture above).
 Clip the MEDI-VAC canister cover on and check that it is fitted over its entire
circumference.
Make sure to hold the bottom of the MEDI-VAC canister during this
operation.
 Repeat the operation with the second canister.

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6.4.2 FAT DISCHARGE TUBING
The fat discharge tubing HPF 1780 connects the handpiece to the MEDI-VAC canister.
This tube is sterile and single-use. It should not be reused and should be replaced before
each operation.

Warning : a single-use sterile equipment should never be used if its packaging is

torn or damaged.

6.4.3 MEDI-VAC CANISTER AND MEDI-VAC BAG

The MEDI-VAC canister has two orifices: one allowing to create a vacuum in the MEDI-
VAC bag (red tube connected to the bag vacuum connector) and the second one allowing
to create a vacuum around the MEDI-VAC bag providing two equal but opposite forces on
the bag walls so that it is perfectly deployed.

To obtain suction at the end of the cannula, it is important to "clip on" the canister
bag on the MEDI-VAC canister (perfect sealing is provided by the blue cover in
contact with the MEDI-VAC canister).

It is strictly forbidden to block one or both orifices allowing to create the vacuum
and connect a positive pressure to the canister bag as well as to the MEDI-VAC can-
ister because it might lead the canister to implode.

It is important to:
 Replace the MEDI-VAC canister bag when it is filled to 90% of its capacity.
 Do not modify the canister bag in order to prevent fat from penetrating into
the motor (this could severely damage the device that could even be
rendered unusable).
 Do not reuse MEDI-VAC bags because, when emptying them, the fat comes
into contact with the filter and, therefore, the proper functioning of this
filter is no longer guaranteed.

Any modification and/or reuse of the MEDI-VAC bag is the responsibility of the user.

ASSEMBLY INSTRUCTIONS:
 Connect the green connector of the aspiration tubing to the “PATIENT” connector
on the MEDI-VAC bag.
 Connect the white connector of the aspiration tubing to the central connector of
the Lipomatic®/evamatic® handpiece.
 All the blue cover connectors should be closed.

Warning : the MEDI-VAC canister has a small “ON-OFF” tap which is used when several
MEDI-VAC canisters are used simultaneously.

 When in “ON” position: the tap is open and suction is turned “on”. The aspirated fat
will be drained into this bag.
 When in “OFF” position: the tap is closed and the suction is blocked at the entrance
of the canister.

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 User manual eva sp® 7

Therefore, the MEDI-VAC canister used for operation should always be set to the
“ON” position and the other canister to the “OFF” position.

If fat enters into the eva sp® 7, please contact the Euromi S.A. company immediately
(see 14-CONTACT OUR TECHNICAL DEPARTMENT).

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 User manual eva sp® 7

7 DESCRIPTION OF THE EVA SP® 7 FUNCTIONING

7.1 START-UP

Before starting up the device, check that the following actions have been done :
1. Connect the electrical power cord and the compressed air hose at the rear of the
device.

Important note: Using an air source not providing medical air is the responsibility
of the user.
2. Connect the two pedals to the connectors at the bottom of the eva sp® 7 front panel.
3. Check that the serum holder is fixed on the eva sp® 7.
4. Make sure that the canister holder as well as the canister are installed on the eva
sp® 7.
5. Connect the Lipomatic®/evamatic® tubing to the “IN” and “OUT” connectors.
Before starting up the eva sp® 7, check that all the connections have been made.
6. Switch on the eva sp® 7 by pressing the “ON” button on the rear panel of the device.
When switched on, the device shows the Homepage.

Picture 1: Homepage

This page allows the user to access to all information about the patient, the operation, the
device maintenance and the language selection.

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7.2 LANGUAGE SELECTION
The default language is the language of the country where the device was supplied, but it
is possible to change it by clicking on the icon in the top right corner (1). A pop-up
window appears. Click on the arrow in the drop down menu (2) and choose one of the five
available languages: French, English, Spanish, Dutch and Portuguese.

Picture 2: Language selection

7.3 PATIENT FILE

This page allows the user to enter the patient file with all details. To access this page,
press the “PATIENT FILE” button in the menu on the left.

Picture 3: Patient file

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You can enter the following data into the programme:

- Surname (25 characters)
- First name (25 characters)
- Birth date (25 characters)
- Gender (tick as appropriate)
- Weight (10 characters)
- Height (10 characters)
- Type of operation (choose the type in the list)

Press the corresponding field defined by a rectangle: a keyboard appears for data entry.
The keyboard has the following keys:
- Standard characters.
- Caps lock key (double-click to stay in upper-case) [1].
- Backspace key [2] to delete the last character entered in the selected field.
- Enter key [3] to confirm and save the data entered in the selected field. The
keyboard then disappears.
- A key to access digital characters and special characters [4].
- The special characters keyboard has a key to switch between QWERTY and AZERTY
keyboards [5].

Picture 4: Entering data into the patient file

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The “New Patient” button is used to create a new file.

Caution, all data (patient file, notes, infiltration and suction) will be
overwritten and it won’t thus be possible to save them anymore. You will
be asked to confirm your selection and validate data overwriting.

Picture 5: Confirmation message to create a new patient record

“Yes” button: The data is deleted and no data will be saved.

“No” button: No data is deleted, and this data can then be saved.

Then enter the information for the new patient.

The “Register” button allows you to export data to a USB stick.

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8 NOTES
The “NOTES” page is used to enter the data you want to keep. To access this page, press
the “NOTES” button in the menu on the left.

Picture 6: Notes page

Data can be entered in a text box using the usual keyboard.

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9 INFILTRATION

The physician using this device is responsible for selecting the physiological fluid.

This page is dedicated to the infiltration part of the operation. To access this page, press
the “INFILTRATION” button in the menu on the left. The gender of the model depends on
the data entered into the patient file.

Pictures 7 and 8: Infiltration page with male and female models

First select the body area on which you are going to work. If the area is located on the
other side of the body, the model can be turned over by using the button at the top right
corner of the page.

Pictures 9 and 10: Infiltration page with the model turned over and a zoom on the upper
body

The body is separated into three parts: the upper body, the lower body and the legs. Press
on one of these parts to zoom it; all selectable zones then appear in grey. The “magnifying
glass” icon with a minus sign is used to zoom out to select a different body zone. Two
other “magnifying glass” icons with arrows are used to move between the three body
zones on the same side.

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When a zone is selected, it becomes green and its name appears in the highlighted zone
on the bottom right. The quantity of fluid infiltrated and the infiltration time are displayed
below the name of the highlighted zone. The total quantity of fluid infiltrated and the total
infiltration time are displayed underneath (all zones combined).

To change from one zone to another, simply select the other zone that will, then, appear in
grey. This zone can be located in a different zone of the body. On the left side of the page,
you can select the infiltration pressure by pressing the button on the right of the display
and then enter the required value (a keypad will appear): the set pressure is displayed
below this text box.

The following pop-up message will appear on the infiltration page: “You can safely install
the syringes and the tubing kit” prompting you to install the syringes and the tubing kit.

Pictures 11 and 12: Adjusting the infiltration pressure and pop-up message prompting the
user to install the syringes and the tubing kit.

9.1 INSTALLATION OF THE SYRINGES AND THE INFILTRATION KIT

The message “You can safely install the syringes and the tubing kit” shows that you can
safely install the two syringes on the two syringe holders.

Important notes:

 Install the syringes and the tubing kit when the “You can safely install the
syringes and the tubing kit” message appears on the screen. Any
manipulation of the syringe pumps in the absence of this message is
dangerous and, therefore, not allowed.

 When placing the syringes on the syringe pumps, do not open the syringe to
prevent any aspiration of air.

 When installing syringes on the syringe holders, do not move the syringe
plunger independently from the syringe. To correctly position the base of the
syringe plunger into the syringe pump, move the syringe pump and not the
syringe itself!

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 User manual eva sp® 7
 It is mandatory to always use the Euromi eva sp® infiltration kit with the eva
sp® systems. This kit is the only one that is compliant and fully compatible
with the devices and that is equipped with the infiltration mode, allowing the
use of one or two bags of physiological liquid.

Now follow the steps hereafter:

1) Place the tubing kit and infiltration fluid bags on the IV stand provided for this
purpose.

The infiltration kit is composed of the following items:

 Infiltration tubing (HPF 8310) (ref.: 1201HPF8310)

Connect to the
IV line bubble
trap (HPF
Connect to
9626).
one of the
infiltration
fluid bags.

 IV line (HPF 9626) (ref.: 1201HPF9626)

IV line bubble
trap

Luer-lock

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 Air tubing for Lipomatic® / evamatic® (HPF 4817) (ref.: 1201HPF4817)

Connect to the
“IN” (I) and “OUT”
(O) connectors of
the eva sp® and
Lipomatic®/
evamatic®

 Fat discharge tubing (HPF 1780) (ref.: 1201HPF1780)

Connect to the central

connector of the
Lipomatic®/
evamatic®

Connect to the “PATIENT”

connector on the fat
canister bag.

Important notes:

 The tubing kits are sterile and single-use. Change the tubing kit
before each operation. Used tubing kits must be discarded.

 The tubing kits are packed following the appropriate procedures. The
tubing kits remain sterile until the protective packaging is opened or
damaged.

 Using tubing kits OTHER than those supplied by Euromi S.A. is the
responsibility of the user. These unauthorized tubing kits do not
comply with the quality and safety requirements of the eva sp® 7
system.

 Do not use any single-use sterile equipment with torn or damaged

packaging.

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2) Install syringes on the syringe pumps and syringe holders

Syringe holder

Syringe

Syringe bracket

Syringe plunger
Syringe pump

Picture of syringes installed into the syringe pumps and syringe holders.

- To install a syringe, open the syringe bracket.

- Using your finger, push the syringe pump up and adjust the base of the syringe plunger
in the syringe pump recess. Gently push the syringe into the syringe holder.

- Place the syringe in both recesses of the syringe holder. For better visibility turn
the graduated scale so that it can be seen.

- Secure the syringe bracket holder to prevent the syringe from falling out of its
recess.

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- Repeat the procedure for the other syringe.

When placing syringes on the syringe pumps, do not open the syringe to prevent any
aspiration of air.

When installing syringes into the syringe holders, do not move the
syringe plunger independently from the syringe. To correctly position
the base of the syringe plunger into the syringe pump, move the syringe
pump and not the syringe itself!

3) Open the three-way valve on the infiltration fluid bag.

The infiltration kit has a device equipped with 2 three-way valves.

To the 2 infiltration fluid bags

To the left To the

syringe right
syringe

The infiltration kit is adapted to use two infiltration fluid bags.

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The valve works in the following way:

O
P
E
N

OPEN OPEN

C
L
O
S
E
D

9.2 CONNECT THE INFILTRATION KIT TUBING

When using the infiltration kit, close the valve of the spare bag and open the valve of the
infiltration fluid bag that you are going to use.

 Connect the blue connector of the infiltration tubing to the bubble trap connector
on the IV line.

 Connect the other connector of this IV line (Luer-lock) to the infiltration cannula
connector.

 Press the “OK” button to confirm that the installation of the syringes and the
tubing kit has been completed.

Any manipulation of the syringe pumps is dangerous and prohibited.

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 Provide a container to purge the syringes, then press the “OK” button in the pop-
up window to confirm the installation of the syringes and the tubing kit.

Pictures 13 and 14: Message for installing the equipment and waiting for initialization

 Please wait while the device is initializing. The purging cycle will start
automatically. It is used for emptying the air from the syringes using the pedal.
 After starting the purging cycle and when the pedal is not active, the “Infiltration”
button will appear.

Picture 15: Activating the infiltration

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9.3 INFILTRATION CYCLE
After purging, press the "Infiltration" button to go to the actual infiltration.
The syringes are completely filled with saline solution.
Press the pedal to infiltrate the saline solution from the first syringe.
The eva sp® 7 is able to calculate not only the total amount of fluid infiltrated, but also the
amount infiltrated in the various zones. It is therefore possible to change the infiltration
zone and know at any time the amount of fluid infiltrated into the zone.
It is also possible to increase or decrease the speed of filling and emptying the syringes
using the black “INFILTRATION SPEED” button at the back of the device.

Picture 16: Rear panel of the device

The minimum speed is +/- 120 ml per min.

The maximum speed is +/- 360 ml per min.

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 User manual eva sp® 7
To select the infiltration pressure, go to the left side of the page, press the button to the
right of the ‘Pressure’ text box and enter the required value (a keypad will appear): the
set pressure is displayed below this text box.

The process is controlled with the pedal according to the selected mode (snapshot or
continuous) using the button in the bottom left corner. The current operating mode is
displayed on a screen; you can change the mode at any time by pressing the same button.

Picture 17: Infiltration Page

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10 SUCTION

This page is dedicated to the suction part of the operation. To access this page, press the
“SUCTION” button in the menu on the left. The page has the same format as the
Infiltration one. In the same way as for infiltration, first select the zone for suction, on
which you will work. When this zone has been infiltrated, the information (amount and
time) is summarized on the lower right corner of the screen. You can adjust the pressure
and the vacuum for suction. (The “–” sign differentiates the vacuum from the pressure).

Picture 18: Suction Page

To start the suction, press the "Suction" button in the top left corner. The process is
always controlled with the pedal according to the selected mode (snapshot or
continuous).

Before starting the suction, perform the following steps:

- Set the fat harvesting container valves:
 The valve is in “ON” position: suction is turned ‘on’ in the aspiration
canister bag.
 The valve is in “OFF” position: the suction is closed at the inlet of the
canister.
Therefore, the MEDI-VAC canister used for the operation must always be set to the
“ON” position.
- Remove the Lipomatic® / evamatic® infiltration cannula.
- Connect the green connector of the fat tubing on the handpiece to the canister
cover and connect the white connector of the tubing to the handpiece.
- Screw the aspiration cannula onto the Lipomatic® / evamatic® (carefully and with
a slightly tightening movement).

Before changing zone (after suction) enter the total amount aspirated into the text box in
the top right corner (under the magnifying glass). Once the total amount is entered, the
amount of fat aspirated for the current zone will be calculated automatically and
displayed in the appropriate zone.

A button next to the input box of the total amount aspirated will appear. This button is
used to correct the total amount (and consequently in the selected zone) if an error was
made when entering the value.
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11 “SNAPSHOT” AND "CONTINUOUS” MODE

There are two operating modes for infiltration/suction: snapshot and continuous mode. It
is possible to choose between these two modes by selecting one or the other using the
“Snapshot” and “Continuous” buttons on the front panel of the eva sp® 7 console.

11.1 SNAPSHOT MODE

The infiltration (or purging) / suction (depending on the current operation mode) and the
Lipomatic®/ evamatic® start when the pedal is pressed and stop when it is released.
These operations resume when you press the pedal again.

11.2 CONTINUOUS MODE

The infiltration (or purging)/suction and the Lipomatic® / evamatic® start when the
pedal is pressed and continue until the pedal is released.
Pressing the pedal again stops the Lipomatic®/ evamatic® and the infiltration (or
purging)/suction.

Note: The eva sp® 7 is supplied with two pedals. They have the same functions and can
operate independently from each other.

 The aspiration time is indicated on the bottom right corner of the page
 Enter the amount by pressing the corresponding grey field (a keypad will appear).
 Change the zone to be aspirated at any time by pressing a zone in the grey area
(provided that the control pedal is not activated and that the suctioned amount is
entered).

Use the green switch I/O (ON/OFF) situated at the back of the device to turn the eva
sp®7 off. When in “O” position, the signal lamp of the switch goes out. It is important to
disconnect the compressed air supply.

The device can, then, be cleaned and disinfected using a cloth soaked with methyl or
denatured alcohol. The device should not be sterilized.

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12 SERVICING, STORAGE AND MAINTENANCE OF THE EVA SP® 7

12.1 SERVICING
In case of failure of the device, all the information related to this device can be recovered
on the maintenance page and may be useful for the after-sales service. To access this
page, press the icon with a question mark, on the top right corner of the homepage.

Picture 19: Software Information

On the maintenance page, you can find the following information:

- Name of the software
- Version of the evamatic® software : 1.0.1.2
- Copyright
- Manufacturer

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 The eva sp® 7 and the MEDI-VAC canister can be cleaned and
disinfected on the surface using a cloth soaked with denatured alcohol
or disinfectant.

The canister bags are single-use only. Reusing them is the sole
responsibility of the user.

 Before cleaning the eva sp® 7:

 Switch off the device
 Disconnect the compressed air supply
 Remove and discard all consumables

 Clean the outer surface of the eva sp® 7 using a cloth soaked with
denatured alcohol or disinfectant.

 The eva sp® 7 should not be sterilized.

 Once a month, open the small valve located at the bottom left of the
device rear panel to drain the oil from the silencer oil trap.

 Replace the syringes kit after each infiltration.

 Under normal operating conditions (clean room, well ventilated, dust-

free, at a maximum ambient temperature of 40°C and with an
acceptable pressure) after about 10,000 hours of service and not later
than after 2 years, the piston seal and the pump sleeve seal have to be
changed.

 Never open the casing, the inside maintenance of the eva sp®7 device
should be done exclusively by a Euromi S.A. technician or a technician
approved by it. The maintenance must be done once a year, when the
device is not used on a patient.

 The temperature of some parts inside the device (the aspirator motor)
can reach more than 80°C. There is, therefore, a burn hazard so never
open the casing.

 Refer to the Lipomatic® / evamatic® user manual for information on

maintenance and servicing.

 The maintenance of the eva sp® 7 system should be done annually by

the Technical Department of Euromi S.A. or by a technician authorized
by Euromi S.A.

Important note: The periods of time given above are guidelines only. They are closely
related to the operation and storage conditions and are, therefore, likely to vary. Contact
Euromi S.A. for more information.

The maintenance procedure is available for Euromi S.A. technicians or technicians

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approved by it.

12.2 STORAGE

 Between uses, store the eva sp® 7 in a dry place, away from dust and
vibrations.

 The device must be kept in a place where the temperature ranges from 0° to
40°, with a relative humidity between 40 and 70%. Do not keep the device
in a place where the atmosphere is unstable (explosion hazards, etc.).

 Ideally, the eva sp® 7 must be kept at an atmospheric pressure ranging

from 950 KPa to 1050 KPa.

 When moving or storing the eva sp® 7 between two operations, grip
the EVA sp®7 with two hands and move it using its wheels. Move the
device carefully in order not to make it fall.

 If the storage period exceeds 4 years, the eva sp® 7 system should be fully
serviced by the Technical Department of Euromi S.A. or by a technician
authorized by Euromi S.A.

 Remove the dust from the air vents to allow free air circulation in the casing
and check that nothing obstructs it. Be careful that there should be enough
space for air circulation behind the casing. Avoid hot air blowing onto the
eva sp® 7.

During transportation, the eva sp® 7 must be kept upright and handled with care.
The room temperature must range from 0 to 40°C and relative humidity must be
between 40 and 70%. Ideally, the eva sp® 7 should be used at an atmospheric
pressure of 950–1050 kPa.

12.3 MAINTENANCE

 The maintenance of the eva sp® 7 system should be done once a year by the
Technical Department of Euromi S.A. or by a technician authorized by Euromi
S.A.

Important note: The periods of time given above are guidelines only. They are closely
related to the operation and storage conditions and they are, therefore, likely to vary.

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 Fuse replacement:

 Remove the plug from the power socket.

 Using a screwdriver, unscrew the fuse compartment cover located in the
power supply unit.
 Remove the blown/defective fuse and replace it with a fuse of the same
rating and type. (Never bridge a fuse).
- Note 1: There are two fuses in the eva sp® 7 power supply unit (4A
for 200/240V∼ supply voltage or 8A for 100/115V∼supply voltage).
- Note 2: Two spare fuses are provided in the rear panel.
- It is important to only use the fuses provided by the Euromi S.A.
company

 If the system performance decreases, contact the Technical Department of

Euromi S.A., see the contact information in section 15.

 Refer to the Lipomatic®/ evamatic® user manual for information on

maintenance and servicing.

 Do not obstruct the air inlets at the back of the device in order to avoid
overheating.

 The eva sp® 7 has a 10-year service life. This service life has been determined
based on the service life of the components and on the possibility to replace
them at a reasonable price.

 If the eva sp® 7 unexpectedly stops during an operation, the manually operated
handpiece is available to complete the current operation.

Never open the casing. Repairs or maintenance of the eva sp® 7 must only be carried out
by the Technical Department of Euromi S.A. or by a technician authorized by Euromi S.A.
It is highly recommended to perform the maintenance once a year.

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12.4 POSSIBLE FAILURES

You will find below some of the possible failures that can happen and that can be resolved
by the user:

 The eva sp® 7 does not turn on:

Check that the electrical power cord is fully plugged into the device and into the
wall socket. If the problem persists, replace the fuse and contact Euromi S.A.

 The aspirator does not work:

Check that the canister bags are secured on the canister and that the white
silicone tube located beneath the canister holder and connecting the canister to
the device is not damaged, torn or clamped.

 The pedal does not work:

Check that the pedal is properly connected to the connector at the base of the
device and that the black hose of the pedal is not damaged or torn.

12.5 TECHNICAL CHARACTERISTICS OF THE ASPIRATOR

The vacuum pump:

Type Voltage (V∼) / Final Power Noise level Weight

Frequency vacuum (W) dB (A) (kg)
(Hz) (mbar)
Series 2660 115/60 - 914 530 56 6.7

The aspirator is a suction device that has a high depression level as well as a high
flow.

You can work simultaneously with the aspirator and with the
Lipomatic®/evamatic®

When using the Lipomatic® / evamatic® in suction mode, check the

aspiration on the end of the cannula. Otherwise, contact the Technical
Department of Euromi S.A. (see contact details in section 15).

12.6 FAT IN THE EVA SP®7

If, despite our recommendations, fat enters into the eva sp®7 and therefore goes
into the aspirator, please contact Euromi S.A. immediately (see section 14, -
CONTACT OUR TECHNICAL DEPARTMENT).

Aspiration pump:
Use it according to its intended use: vacuum pumps are suitable only for aspiration of air
or non-aggressive gases that does not contain more than 22% of oxygen. The gas should
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never be toxic nor explosive. Vacuum pumps are also suitable for fluids that are free from
explosive gases.

The aspiration of gas or fluids not defined above can lead to serious injury
or death as well as substantial property damage. For more information,
please contact Euromi S.A.

Frequent stop/starting and/or high ambient temperatures can lead the motor to reach its
temperature limits. For detailed information, contact Euromi S.A.

For optimal safety, the MEDI-VAC bag is equipped with a safety device in order not to
exceed the maximum capacity level.

This device is designed to operate at a room temperature of 0–40°C and with a relative
humidity of 40–70% (ideally, it should be used in an operating theatre).

Do not use the device in a hazardous environment (risk of explosion).

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13 LIST OF ACCESSORIES FOR THE EVA SP® 7

1- eva sp® 7 (ref.: 1114sp7)

2- Pedal (2) (ref.: 5914E123456-005)
3- Air tubing for Lipomatic (HPF 4817) (ref.: 1201HPF4817)
4- Fat discharge tubing (HPF 1780) (ref.: 1201HPF1780)
5- IV line (HPF 9626) (ref.: 1201HPF9626)
6- Infiltration tubing (HPF 8310) (ref.: 1201HPF8310)
7- Compressed air supply hose (5 meters) (ref.: 5915ATL)
8- Electrical power cord (ref.: 5911BD12E123456-001)
9- MEDI-VAC Canisters (ref.: 1752-65652631)
10- MEDI-VAC bags (ref.: 1752-65651930)
11- IV stand (ref.: 5914E6-020)
12- User manual (available on the website:
www.euromi.com)
13- USB stick (containing the manual, packing list, videos
and pictures of operations, ...)
If you are missing one or more accessories, contact Euromi S.A. or your distributor:

This list of accessories may be subject to change.

These accessories are also included in the packing list accompanying the shipment.
Using accessories OTHER than those supplied by EUROMI S.A. is the sole
responsibility of the user. These unauthorized accessories do not comply with
the quality requirements of the EVA sp® 7.

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14 CONTACT OUR TECHNICAL DEPARTMENT

For any questions, please contact the Technical Department of Euromi S.A.:

n.v. Euromi S.A.

Zoning Industriel de Lambermont
Rue des Ormes 151
B-4800 VERVIERS
Tel.: +32 (0)87 29 22 22
Fax: +32 (0) 87 29 22 23
sav@euromi.com
info@euromi.com

15 CANNULAS
Refer to the cannula user manual for information on cleaning and decontamination
procedure.

The cannulas compatible with the Lipomatic® / evamatic® are listed in the cannula user
manual.

16 LIPOMATIC / EVAMATIC
Refer to the Lipomatic® / evamatic® user manual for information on the Lipomatic® /
evamatic® cleaning and decontamination procedure.

The accessories compatible with the Lipomatic® / evamatic® are listed in the Lipomatic®
/ evamatic® user manual.

Any use of the device outside of its intended use described in this manual is not the
responsibility of Euromi S.A.

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17 INDICATIONS – PURPOSES

The eva sp® range systems – Lipomatic® / evamatic® – cannulas are used for the
following purposes:

1. The therapeutic indications:

 Treatment of obesity, gynaecomastia, ptosis, macromastia or heart disease
and/or diabetes complications.
 Treatment of lymphoedema, lipomas, lipomatosis (including congenital li-
pomatosis of the face) and haemangiomas.
 Treatment of various disorders such as axillary sweat hypersecretion.
 Adipocyte grafting as part of reconstructive surgery.

2. Aesthetic indications:
 Figure liposculpture.
 Liposculpture of the gluteal region.
 Remodelling the face and re-injection in the face including the restoration of
volume and shape of a thinned face, filling and attenuation of some wrinkles,
improving facial harmony, …
 Remodelling and re-injecting the breast (such as the increase in breast size,
potential alternative to breast implants).

3. Additional indications:
 Prospects offered by the adipocyte grafts (both from an aesthetic and thera-
peutic point of view).

It is important to note that liposuction, liposculpture and lipofilling are surgical

procedures that should be performed by a competent and qualified physician or surgeon
specifically trained for this type of technique and working in a surgical environment.

19 CONTRAINDICATIONS

There are only few contraindications against lipoaspiration.

According to the article:
http://liposuccion.comprendrechoisir.com/comprendre/liposuccion_contre_indications,
and the publication of Venkataram Mysore : « Tumescent liposuction : Standard
guidelines of care », Indian J Dermatol Venereol Leprol 2008 page S54 to S60, we were
able to identify the contraindications hereafter :

- People with diabetes

- People with leukemia
- People with hypertension
- Pregnant and breast-feeding women (precaution)
- Heavy smokers
- People on anti-depressant medication
- People on a medication causing bleeding

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20 STUDIES ON the N.I.L. TECHNIQUE® — REFERENCES

This list is not exhaustive. Each article confirms the benefits of this device when used for
liposuction.
- Abboud MH, Dibo SA. (2015, March 30). “Immediate Large-Volume Grafting of
Autologous Fat to the Breast Following Implant Removal”. Aesthet Surg J., 35(7),
pp. 819-829.
- Abboud MH, Dibo SA. (2015, July 24). “Power-Assisted Liposuction Mammaplasty
(PALM): A New Technique for Breast Reduction.” Aesthet Surg J., pp. 1-13.
- Abboud MH, Dibo SA, Abboud NM. (2015, September 15). “Power-Assisted
Gluteal Augmentation: A New Technique for Sculpting, Harvesting, and
Transferring Fat.” Aesthet Surg J., pp. 1-8.
- Benito-Ruiz J., Raigosa M., Manzano M., Salvador L. (2009, July). ”Assessment of
a Suction-Assisted Cartilage Shaver Plus Liposuction for the Treatment of
Gynecomastia.” Aesthetic Surgery Journal, 29(4), pp. 302-309.
- Brorson H. ; Svensson H. (1997). “Complete reduction of lymphoedema of the
arm by liposuction after breast cancer.” Scandinavian Journal of Plastic and
Reconstructive Surgery and Hand Surgery, 31, pp. 137-146.
- Brorson H. ; Svensson H. (1998). “Liposuction combined with controlled
compression therapy reduces arm lymphedema more effectively than controlled
compression therapy alone.” Plastic and reconstructive surgery, 102(4), pp. 1058-
1067.
- Brorson, H. (2003). “Liposuction in arm lymphedema treatment.” Scandinavian
Journal of Surgery, 92, pp. 287-295.
- Heymans O. ; Castus P. ; Grandjean F.X. ; Van Zele D. (2006). “Liposuction:
review of the techniques, innovations and applications.” Acta Chirurgica Belgica,
106(6), pp. 647-653.
- Heymans O. and Ronsmans C. (2005) “Congenital infiltrating lipomatosis of the
face” European Journal of Plastic Surgery; Springer-Verlag, pp. 1-7.
- Moreno Gallent I., Ribera Pons M., Tiravanti B. (2012, July - December).
“Treatment of gynecomastia with vibroliposuction.” European Aesthetic Plastic
Surgery Journal, 2, pp. 21-26.
- Dr Otteni Francis (2001, Mei) “Le lipomatic (étude comparative de la
vibrolipoaspiration et de la lipoaspiration classique)” La revue de chirurgie
esthétique de langue française, 25(103), pp. 9-16
- Rebelo Angelo, M.D. (2003, November 1) “Vibroliposuction:
Liposuction/Liposculpture Assisted by Compressed Air” International Journal of
Cosmetic Surgery and Aesthetic Dermatology, 5 (1), pp. 77-82.
- Rebelo Angelo, M.D. (2006, January) “Power-Assisted Liposuction” Clinics in
plastic surgery: Elsevier Sauders, 33(1), pp.91-105.
- Tonini D. and Calvisi L. (2014) “The medical/Surgical minilifting : association of
volumizing hyaluronic acid and neck counturing for the rejuvenation of the
medium/inferior third of the face.” Journal of Plastic Dermatology, 10(1), pp.57-60.
44
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21 WARRANTY CERTIFICATE

Warranty Certificate

This form must be returned to Euromi S.A. within 30 days after installation or receipt of
the product.

I, the undersigned, ……………………………………………………………………………………...

Company: …………………………………………………………………………………….

Address:
………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………

Declare having received the eva sp® 7 N°. ………………………………….. in working condition.

I have received all the necessary instructions for its use, maintenance, service, etc. and I
have followed a specific a training.

I confirm having understood this training :

Yes  No 

In the event that Euromi S.A. or its distributors have not received this form duly filled in
and signed within one month after delivery with a copy of the purchase invoice, Euromi
S.A. will be discharged from all liability regarding the warranty and after-sales service or
any further consequences due to improper use of the device.

Signed in …………………………..…………. on …………………………………………

Signature:

User:

Return to:
Euromi S.A
ZI de Lambermont
Rue des Ormes 151
B-4800 Lambermont
Fax: 0032/87 29 22 23
sales@euromi.com

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22 SATISFACTION SURVEY

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