Silfradent MEDIFUGE CGF User manual

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ENGLISH
USER MANUAL
MEDIFUGE CGF
MEDIFUGE CGF

FT 01-MUE-MEDIFUGE_Rev10.docx Silfradent S.r.l. March 2021 age 2 of 28
TABLE OF CONTENTS
INFORMATION TO THE USER ........................................................................................................ 4
Notice ........................................................................................................................................ 4
Meaning of Pictogra s ............................................................................................................. 4
Warnings ................................................................................................................................... 5
Classification of the device ...................................................................................................... 5
Safety and safe switching off ................................................................................................... 5
Safety Warning ......................................................................................................................... 6
Electric Hazards ...................................................................................................................... 6
Mechanical Hazards ................................................................................................................. 6
Other Hazards. ........................................................................................................................ 6
Precautions ............................................................................................................................... 7
MEDIFUGE CGF Features .......................................................................................................... 7
Waste Disposal ......................................................................................................................... 8
Guarantee ................................................................................................................................. 8
Transport and Storage.............................................................................................................. 8
DESCRIPTION ................................................................................................................................ 9
Field of Application and Use ..................................................................................................... 9
Description of CGF .................................................................................................................. 9
Intended Use .......................................................................................................................... 9
General Description ................................................................................................................. 9
Equip ent of Centrifuge ........................................................................................................10
Accessories Provided with the MEDIFUGE CGF .....................................................................10
Disposable arts.................................................................................................................... 10
Sterilisable Containers ........................................................................................................... 12
Commercial Tools .................................................................................................................. 13
Instruments Specially Designed for the CGF ............................................................................. 14
Targhetta dati MEDIFUGE CGF ...............................................................................................15
Barcode of the device ............................................................................................................ 15
Codice a barre scatola ..................................................... Errore. Il segnalibro non è definito.
Rotor Label ........................................................................................................................... 16
Fuses .......................................................................................................................................16
INSTALLATION AND MAINTENANCE OF THE CENTRIFUGE ........................................................16
Installation and Use ...............................................................................................................16
Removing the Equipment from ackaging ................................................................................ 16
reparing the Centrifuge ........................................................................................................ 17
Maintenance and Cleaning .....................................................................................................17
Cleaning of the Centrifuge ..................................................................................................... 18
Disinfecting the Centrifuge ..................................................................................................... 18
Sterilization of the Centrifuge ................................................................................................. 18
Cleaning of Accessories .......................................................................................................... 18
Sterilization of Accessories ..................................................................................................... 19
Maintenance of the Centrifuge ................................................................................................ 19
Technical Support ................................................................................................................. 19
Removing the Rotor .............................................................................................................. 20
Replacement of the UV Lamp ................................................................................................. 20
Manual opening of the lid ....................................................................................................... 20
OPERATION ..................................................................................................................................21
Description of Control Panel ..................................................................................................21
Setting and Viewing Operating Data .....................................................................................21
Description of Operation ........................................................................................................ 21
General Description of CGF Preparing Process ......................................................................23
repare a Membrane with CGF K1 FM ................................................................................... 23
Use of Fibrin Injector CGF K1 INF ........................................................................................... 23
Using CGF with THE HOMOGENIZER ROUND UP ...................................................................24
SERVICE .......................................................................................................................................25
Troubleshooting .....................................................................................................................25
Safety Warning .......................................................................................................................27
ELECTROMAGNETIC ENVIRONMENT ...........................................................................................28

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Fig. 1-1 Centrifuge
Fig. 1-2 Accesories

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INFORMATION TO THE USER
NOTICE
Please note
The Italian version of this anual is the aster fro which translations derive.
In case of any discrepancy, the binding version is the Italian text.
Read these instructions for installation, use and aintenance of the device, before beginning operation,
in order to avoid i proper use and any type of da age or injury.
MEANING OF PICTOGRAMS
Both packaging of components and this booklet contain the symbols explained below.
Hazardous situations for the opera-
tor and/or the patient.
Biological hazard.
Electrical hazardous situation
Consult instructions for use or
Consult operating instructions.
Caution, consult accompanying doc-
uments.
The device has not been sterilized; it
must be sterilized before use.
Sterilized using Ethylene Oxide. Sterilized using irradiation.
Sterile medical devices processed
using aseptic techniques.
Sterilzed using steam or dry heat
Batch Code Catalogue number
Do not re-use
Date of manufacture: this symbol is
adjacent to the date that the product
was manufactured
Use by date: close to this symbol
there is the expiry date
Manufacturer’s data: this symbol is
adjacent to the name and address of
the manufacturer.
Steam sterilisable at max 135°C
This symbol is a mandatory marking
for devices entering the European
market to indicate conformity with
the essential health and safety re-
quirements set out in European Di-
rectives.
The symbol may be accompanied by
a four-digit identification number of
the notified body.
Not for general waste: this symbol is
used to mark devices that are reusa-
ble and not contaminated at the end
of the device life.
Read instruction for use

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WARNINGS
This manual is designed to the centrifuge for dental
practice and specialized outpatient clinic MEDIFUGE
CGF with its accessories, for its intended purposes
The Manufacturer of this medical device is:
Silfradent S.r.l.
VIA G. Di Vittorio N°35/37
47018 S. Sofia (FC), ITALY
Tel. [phone] Fax [phone]
WEB: www.silfradent.com E-mail: [email protected]
Silfradent S.r.l. congratulates and thanks you for
choosing this device.
Below, we provide some preliminary information to help
you in the initial use of the equipment.
It is important that you make sure that the package
contains the guarantee certificate and that this is filled
in and stamped by the retailer.
The accessories provided with MEDIFUGE CGF were se-
lected to perform each operation necessary for prepar-
ing and using CGF in a sterile ambient to avoid contam-
ination of autologous implant material.
Please note.
Before removing the equipment from packaging, check that all the components described in para-
graphs 2.2 (Centrifuge) and 2.3 (accessories suitcase) are in.
After carefully extracting the components of MEDIFUGE
CGF from the packaging, place them on a table and
check that there are no damages deriving from
transport, in this case immediately contact the retailer.
Silfradent S.r.l. has drafted this Manual with the aim to
help the user and facilitate the start-up and operation
of the equipment.
Silfradent S.r.l. accepts no responsibility for
changes to the equip ent or da ages to third
parties arising fro isuse.
Each piece of equip ent is supplied with a copy
of this booklet
Compliance with the instructions contained in this tech-
nical document is necessary for correct operation.
The use of the equipment for uses different from those
indicated in these instructions and in the brochures is
absolutely forbidden.
Non-compliance with the instructions herein contained
results in the immediate termination of the guarantee.
Please note.
For any request, always quote:
The date of purchase, device model and serial number which can be found on the data label on the
back side of the MEDIFUGE CGF.
The removal of the data plate causes the warranty to be forfeited
CLASSIFICATION OF THE DEVICE
The equip ent is classified:
According to the type of protection against electric haz-
ards. Equipment supplied by an external source of elec-
tric energy.
Class I equip ent
According to the degree of protection against direct and
indirect contacts. No applied part
According to the degree of protection against liquid pen-
etration. Console is classified as IpX0.
According to the degree of safety of use in the presence
of an anesthetic mix inflammable with air, oxygen or ni-
trous oxide.
NO PROTECTION.
According to the conditions of use. Equip ent for continuous operation, the operating
cycles are preset.
SAFETY AND SAFE SWITCHING OFF
Before using the equipment, the user must check equip-
ment status. Stop operation if there are components
that are not in perfect conditions.
Turn off the mains switch and disconnect the power
cord from mains socket before leaving the device unat-
tended.
Never use the machine in the case of damages.
Always check the expiry date of the disposable accesso-
ries and the integrity of their packaging before using.

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Please note.
Check that the power source is equal to the value on data label placed in the rear side of the machine.
SAFETY WARNING
Electric Hazards
Warning!
To avoid the risk of electric shock, this equipment must only be connected to an outlet with a protective
earthing connection.
NEVER use solvents or flammable materials near this or other electrical equipment.
When cleaning or disinfecting be careful that no liquid enters the unit.
Never extract or handle the power cord with wet hands (risk of electric shock)
Da aged power cord/ issing protective conductor.
 Check the mains cable before use.
 The socket outlet must have a protective contact and meet the respective national guidelines.
 Always completely insert the power cord into the socket of the device before connect to the
mains.
This equipment complies with EMC standards in force however as a guarantee of equipment safety,
we recommend that the use of mobile phones in the consulting room or clinic be prohibited.
aragraph 6 contains the information on electromagnetic compatibility.
Caution!
Never carry out any maintenance or cleaning without removing the power cord.
Please note.
To isolate the device from mains remove the power cord from the outlet or from the connector in the
back of the equipment.
Mechanical Hazards
Warning!
 At the end of the cycle the machine will open by itself, do not try in any way to unlock the cover
during operation, it could be dangerous for the operator and people nearby.
 In case of switching off and immediate switching on, the machine opens only when the rotor
stops, do not try to force the cover.
 Never operate Centrifuge with rotor unbalanced, the machine could be dangerous for the opera-
tor and people nearby.
 Never operate Centrifuge on an unstable or tilted surface, the machine could be dangerous for
the operator and people nearby.
Other Hazards.
Caution!
 The holders included in the rotor are used to hold the tubes of blood to be centrifuged, no other
use is allowed.
 The blood must not contact the Teflon container that, in this case, they have to be carefully
washed and sterilized.
 Never attempt to open the lid of the machine during the UV cycle could be harmful to the eyes.
 The reusable accessories provided in the kit, before use shall be washed, disinfected and steri-
lized. When packed are cleaned but not sterilized.

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PRECAUTIONS
Caution!
 Never use the centrifuge in a different mode than as specified in these instructions.
 Never operate the centrifuge without a rotor properly attached to the shaft.
 Never fill the tubes while they are in the rotor.
 Never put your hands in the rotor area without the rotor completely stopped.
 Never move the centrifuge while the rotor is spinning.
 Always load the rotor symmetrically. Another with the same weight should counterbalance each
tube.
 lace the centrifuge near an electrical outlet easily accessible.
 Use only the test tubes recommended from Silfradent .
Warning!
No odification of this equip ent is allowed..
Before each use:
 Always check the condition of the accessories
 Check the expiration date of the single use accessories indicated on the single pack.
 Avoid using parts that are not in perfect condition or expired.
The technical data, information and product features
described in the instructions for assembly and use cor-
respond to current specifications at the time of publica-
tion of this manual.
Modifications may be made to the product on the basis
of technical innovations, although this does not entitle
the user to the corresponding modifications on appli-
ances which have already been installed
MEDIFUGE CGF FEATURES
Internal code Power supply External fuses
MF 200 230 Vac +/-10%50/60 Hz 120VA 2x T 1,25 AL 250 V
MF 200 100 100-115 Vac 50/60 Hz 120VA 2x T 2 AL 250 V
Operator interface Three digits LED display two buttons
Motor DC 24 V 6500 rpm
Internal fuses replaceable only
by service personnel
1 x T 6,3 AL 250 V
1 x T 0,63 AL 250 V
Di ensions D x W x H 280 x 320 x 240
Weight 9,4 kg (only the centrifuge)
Environ ental conditions Internal use, height up to 2000 m above sea level, Humidity up to 80%
Ambient Temperature 2°C TO 40°C

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WASTE DISPOSAL
Hazardous health waste
Sanitary waste means any material contaminated by:
 human or animal blood;
 micro-organisms even if genetically modified and cell cultures that could cause infections, aller-
gies, poisonings and other damages to the human organism;
 human or animal tissues;
 human or animal organic liquids;
 carcasses of animals used for experimentation or other scientific purposes.
Disposable accessories must be disposed of as hazardous medical waste.
Reusable accessories (metal containers or tools) must be disposed of only after placed in safe con-
dition
The equipment must not be considered a solid urban waste, it is an electrical and electronic equip-
ment (WEEE).
For further information consult the office of Silfradent S.r.l. closer to you.
 No hazardous waste must be discharged into the sewers or municipal waste.
 Every person who uses, handles or eliminates hazardous biological waste materials must be in-
formed about the appropriate disposal methods.
 It is the responsibility of each user to follow the established procedures and to comply with ap-
plicable national laws and regulations.
GUARANTEE
Silfradent S.r.l. guarantees to the purchaser that it will
repair or - to its sole discretion - replace any part which
is defective with regard to construction or materials, in
normal conditions of use, for the period of one year
from the date shown on the serial number plate on the
back of the equipment.
Silfradent S.r.l. is not liable for any da age de-
pending on:
 External causes (poor quality of liquids or in-
correct installation)
 Use of the equip ent not in co pliance with
the regulations in force
 Unsuitable repair
 Changes ade by unauthorized third parties
Repairs and maintenance of the device are the respon-
sibility of Silfradent S.r.l. technicians or staff authorized
by Silfradent S.r.l.
Only original spare parts must be used to repair MEDI-
FUGE CGF.
Nota bene.
For use and repairs of MEDIFUGE CGF Centrifuge only original spare parts must be used.
Replacement of accessories must be with parts supplied or recommended by Silfradent S.r.l.
The guarantee is provided ex-factory SILFRADENT S.r.l.
The guarantee does not cover defects or da age arising fro :
 Use not in compliance with the instructions of this manual.
 Incorrect or unsuitable maintenance by the user.
 Unauthorized opening of the external casing.
 Unauthorized tampering or changes.
 Operation not in compliance with the environment specifications indicated for the product.
 Use of non original accessories.
 Cleaning with unsuitable products
TRANSPORT AND STORAGE
In the case of return shipment, wrap the product cor-
rectly by using the original package, if possible.
It is advisable to insure the package.
The customer has full responsibility for damages arising
from unsuitable packaging.
Transport and storage of the equipment MUST BE
CARRIED OUT into original packaging at a tempera-
ture range of -40 to +70 °C ", with relative humidity 10
to 90% and pressure range between 500 and 1060 H A.

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DESCRIPTION
FIELD OF APPLICATION AND USE
Description of CGF
It is every surgeon’s wish to have material that heals
wounds and prevents all the secondary effects of surgi-
cal procedures (oedema, dehiscence, infection, haema-
toma, etc.). Growth Factors are molecules that can cer-
tainly activate these processes. They can be natural or
synthetic. The distinctive feature of GFs (Growth Fac-
tors) is the excellent reactivity even at very low concen-
trations. In fact, we are in the order of μg.
It is certainly better to extract GFs directly from the pa-
tient’s tissue. Blood is the donor tissue that is the easiest
to handle.
The best-known GF extraction techniques are:
 Fibrin Sealant (Tissucol Baxter)
 c R platelet concentrate (Marx 1998)
 latelet rich plasma ( R )
 lasma rich in growth factors ( RGF E. Anitua)
 Fibrin rich plasma (2001 J. Choukroun)
 CGF (Concentrated Growth Factors 2006, IAIO)
The C.G.F. (Concentrate Growth Factors) is a reparative
biomaterial comparable to the platelet and fibrin con-
centrate, which enhances the characteristics of this
technique. The autologous matrix consists of a Fibrin
block and a platelet concentrate, with a large amount
of:
 lasma cytokines
 latelets: thrombocytes
 Activated fibrin
 Leukocytes
 GF
 Antibodies
Special biological properties of C.G.F.:
 Blood coagulation with the formation of a flexible
and elastic fibrin network.
 Neo-angiogenesis (promoting vascularization and
graft survival)
 lasma cytokine activation
 Local immune system activation
 Release of GFs from latelet disaggregation and fi-
brin concentrate.
CGF-induced processes:
 Angiogenesis
 Immunisation
 roliferation of fibroblasts and osteoblasts.
 Repair stimulation and modulation
Structural and mechanical properties of CGF:
 slow and natural polymerization leads to a concen-
tration of physiological thrombin
 Trimolecular and multiple fibrin monomer junctions
 thin, soft, elastic, and permeable network allows
for the colonization of reparative cells, red blood
cells, white blood cells, platelets, and anti-bodies.
C.G.F. is prepared by drawing the patient’s blood into
10 ml glass tubes V 200R, which are centrifuged im-
mediately with MEDIFUGE CGF by Silfradent S.r.l. up
to 8 tubes can drawing and centrifuged simultaneously.
A single centrifugation without adding any other sub-
stance gives 3 fractions in each tube. A lower part where
all the red blood cells are located, an upper part with
the platelet poor plasma ( ), and a fibrin clot between
these two fractions, which will be removed from the
tube and separated from the red fraction using scissors.
The clot can be used in form of a membrane by pressing
it or crushed into smaller fragments.
Intended Use
The centrifuges MEDIFUGE CGF by Silfradent S.r.l.
with the accessories of the kit were designed to process
blood obtaining C.G.F. in a sterile environment so as not
to contaminate the material to be implanted.
Any use other than that specified is not al-lowed.
MEDIFUGE CGF is a centrifuge for dentistry, cosmetic
surgery and general surgery.
This centrifuge must be used combined to the selected
or specially designed accessories of this kit to obtain fi-
brin clots and blood components to be used in:
 periodontology
 implantology
 Maxillo-facial surgery
 cosmetic surgery
 general surgery
 healing of ulcers
 healing of wounds.
The environment of use of the centrifuge must be at a
maximum temperature between 20 and 25 °C since the
separation of the blood to obtain the CGF must be done
inside this temperature range.
General Description
MEDIFUGE CGF is a powerful and versatile centrifuge
that offers direct operation, for maximum ease to use.
MEDIFUGE CGF is the result of a close collaboration
with experienced dentists and surgeons and of a careful
study of current technological innovations in the elec-
tromechanical and electronic field.
The rotor shape and the inclination of the tubes were
designed to obtain great results during the use.
The machine is designed to operate only with original
rotor and test tubes holder.
MEDIFUGE CGF has two operating cycles for blood
centrifugation in order to obtain fibrin concentration and
fibrin clots.
To protect the motor the control card is equipped with
a current and voltage control to avoid electrical over-
loads. When occurring a failure of the machine or of the
of the control card the lid remains closed until the stop
of the rotor.

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EQUIPMENT OF CENTRIFUGE
1 Centrifuge
1 MF2COPR Rotor
8 Tube holders ade with Tef-
lon®, to contain 10 l test
tubes
1 Power cord
1 Certificate of Guarantee
1 Declaration of Confor ity
1 User's Manual and Maintenance
The centrifuge is supplied with the rotor already fixed to motor shaft and the tube-holder inserted in their sites.
Please note!
The rotor and the tube holders supplied with the device are the only ones usable with the machine.
They were designed for the specific intended use.
ACCESSORIES PROVIDED WITH THE MEDIFUGE CGF
Please note!
The images of accessories may vary
Disposable Parts
Please note!
The aterials listed below have an expiry date indicated on the packaging. Always
check this date before use.
These materials have been sterilised by the manufacturer; therefore, on the packaging is marked
the symbol of the sterilisation method.
Always check integrity of packaging to make sure of their sterile condition
Do not dispose as solid urban waste, refer to a special waste collection centre
Disposable devices subject to expiry.

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The expiry date is beside or under this symbol.
Sterilization Methods
Device sterilized using Ethylene Oxide.
Device sterilized using irradiation.
Sterile medical devices processed using aseptic techniques.
Sterilized with steam or dry heat.
No Quantity Code Description I age
1 50 CGF K1 TMP01
Swab soaked of disinfectant liquid
to be used on the patient's blood
sampling point.
2 25 CGF K1 LCE Latex free disposable tourniquets
3 24 CGF K1 AGO SAFETY Blood Collection Set:
Needle diameter G21 for Vacuette
system.
4 30 CGF K1 CER01 Hae ostatic plasters for after-
sampling dressing.
5 100 pezzi
PV 200R Silfradent glass vacuum tube
without additives

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No Quantity Code Description I age
9 30 CGF K1 FSL 10 l vials of saline.
Each vial should be used for one
application.
20 25 CGF K1 GAR Garza topper
Sterilisable Containers
The containers in the following list have been chosen for their shape and size, in order to ensure
maximum ergonomics during the process.
Instru ents of the next table are supplied non-sterile; therefore, they ust be
cleaned and sterilised before use.
Can be steam sterilised up to 135°C
No Quantity Code Description I age
7 1 CGF K1 SPF Fibrin separator:
Stainless steel vessel used to sep-
arate the liquid part from the fi-
brin clot, in combination with the
grid CGF K1 GSP
10 1 CGF K1 DFD Dappen for fibrin:
Stainless steel container that fa-
cilitates the formation of the fibrin
clot combined with the saline.

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No Quantity Code Description I age
11 1 CGF K1 DPC Dappen for platelet:
Cylindrical stainless steel con-
tainer intended to contain red
blood clots to prevent the oxida-
tion.
12 1 CGF K1 DPT Dappen for particulate:
stainless steel container intended
to keep the fibrin clot cut into par-
ticles.
Co ercial Tools
Some components of this KITs are commercial devices already used in the medical field and they
were chosen for their features and shape. They are listed in the following.
Tools provided in non-sterile condition, before use ust be cleaned and sterilized.
Can be steam sterilised up to 135°C
No Quantity Code Description I age
13 1 CGF K1 FPS Blunt scissors
14 1 CGF K1 PAD Straight anato ic pliers
15 1 CGF K1 SPD Straight spatula
17 1 CGF K1 COM Co pactor

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Instru ents Specially Designed for the CGF
The components of the kits listed in this table, were specially designed to facilitate the operations
necessary to prepare and use the CGF.
Tools provided in non-sterile condition, before use ust be cleaned and sterilized.
Can be steam sterilised up to 135°C
No Quantity Code Description I age
16 1 CGF K1 FMP Me brane shaping pliers:
stainless steel tool designed to
form membranes by pressing fi-
brin clot
19 1 CGF K1 PMS Spatula applicator for e -
brane:
Stainless steel tool designed to
ease handling fibrin clots or mem-
branes
6 1
CGF K1 PPR Stainless steel tube holder:
this base contains the tubes while
preparing CGF
8 1 CGF K1 GSP Grid for fibrin separator:
Stainless steel grid, designed to
separate the liquid part from the
fibrin clot in combination with the
Dappen for fibrin separation.
21 1 CGF K1 TRA Tray for tools:
This is the container for tools to
be sterilised.
18 1 CGF K1 INF Fibrin injector:
Stainless steel tool designed to in-
ject the fibrin particulate in the
site of application, divided into
two parts.
Caution!
 All the operations to obtain the fibrin clots must be carried out in an environment with a con-
trolled temperature ranging between 20 and 25 °C.
 The machines and materials used must be kept at room temperature.

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TARGHETTA DATI MEDIFUGE CGF
The data plate is in the back side of the centrifuge. It contains the data listed below
Manufacturer’s address
The equipment comply to CE require-
ments verified by competent body Nr
0051 IMQ S.p.a.
Made in Italy Country of manufacture
Refer to safety regulations and to In-
struction Manual
Model
Internal code for device
supplied at 230 Vac
230 Vac
50/60Hz 120VA
ower supply and rated power
of MF 200
Fuse 2xT 1,25 A 250V Type of fuses for MF 200
Internal code for device
supplied at 100-115 Vac
100-115 Vac
50/60Hz 120VA
ower supply and rated power
of MF 200 100
Fuse 2x T 2 A 250V Type of fuses for MF 200 100
Serial number
Do not dispose as urban solid waste,
use the collection centers.
Month of manufacture Follow instruction for use
230 Vac data label 100-115 Vac data label
Barcode of the device
Label with the barcode of the MF 200 Label with the barcode of the MF 200 100

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Barcode and data on pri ary packaging
MEDIFUGE CGF label MF 200 label
MF 200 100 label
Rotor Label
Rotor label
Code of rotor
Lot number
Manufacturer
FUSES
The devices is equipped with two internal protection
fuses located on the power card which can only be re-
placed by authorized personnel and with two external
fuses which can be accessed from the back by remov-
ing the power cord from connector on the equipment
and opening the appropriate cover.
External fuses
Glass fuses Dim. Ø 5 x 20mm
accessible from the back of the console
2 x T 1,25 AL 250V for mains 230 V
2 x T 2 A L 250V for mains 100115 V
Internal fuses
Glass fuses Dim. Ø 5 x 20mm
Replaceable only by service personnel.
1x T 6,3 A L 250V
1x T 0,63 A L 250V
INSTALLATION AND MAINTENANCE OF THE CENTRIFUGE
INSTALLATION AND USE
Re oving the Equip ent fro
Packaging
Even though during the transport preparation and
packing stages all precautions were taken in order to
prevent any forwarding-related damage, it is im-
portant to check the integrity of the equipment, once
taken out from its packing.
 Make sure the outside of the package has not
been subjected to shock or deformation.
 Make sure that suitcase of accessories is not dam-
aged.
 Open the packaging and place on a plane surface
all the components and make sure they are intact.
 Check for the integrity of disposable devices pack-
aging.

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In case any damage is found, an appropriate letter of
complaint should be immediately sent to the supplier.
The equipment packing material should be kept intact
in case it is necessary to send the machine back for
control or overhauling.
In case of return to the supplier always dispatch all
components in order to allow the supplier to verify.
Preparing the Centrifuge
Make sure that in the vicinity of the point where the
device is placed there are no objects (cables, hoses
etc.) which could interfere with its stability.
Keep at least 15 cm free around the machine, this allow
a good aeration of the machine and a safe operation.
Make sure that mains socket is easy accessible
Make sure that machine is not close to excessive hot
sources or exposed to direct sunrays, the chamber of
rotor could warm up and damage the blood compo-
nents inside.
An accurate positioning facilitates the good operation
of the centrifuge.
Always check the mains voltage is the same of that
written in the data label in the back of the machine.
Make sure that the mains switch in the back of the ma-
chine is turned off (position 0) before connect the
power cable to the mains socket.
When turned on, the centrifuge automatically opens
lid.
Completely clean the centrifuge and sterilize the tube-
holders before use.
Always check the rotor is secured to the motor shaft
before start the MEDIFUGE CGF.
Always insert the tubes in pairs and in opposite holders
to balance the rotor as shown in Fig. 3-1 this avoid vi-
brations that could damage the blood components and
results in hazards.
Select the centrifugation cycle to be used as explained
in the paragraph 4 and press the START button.
Fig. 3-1 rotor loading
Wait for the end of cycle, which will be marked by a
beep every minute, at the cycle end after rotor stop-
ping will automatically open the lid.
Please note!
 The equipment should be used by qualified medical personnel only, trained in the techniques for
preparation of fibrin.
 At the end of each cycle the automatically open lid, never try to unlock it during operation, could
be hazardous for user or people nearby.
 When machine switches off and immediately switches on, the lid opens only when rotor is
stopped, never try to unlock it.
Warning!
Never unlock lid during UV cycle, could be hazardous for sight.
CAUTION!
Since it is a device powered with a voltage of 230V or 100-115V you must apply all the necessary
precautions.
Make sure that environment where machine is used comply to electric regulations in force.
Make sure that the mains socket is connected to the protective earth.
MAINTENANCE AND CLEANING
The drugs and chemicals products used in dental prac-
tice or clinic could cause damages to the surfaces of
the machine. As the extent of the damage is directly
related to the reaction time, you should immediately
clean the damaged part by using a soft cloth.
Residues of disinfectants on surfaces can be removed
with detergent or neutral detergent.

FT 01-MUE-MEDIFUGE_Rev10.docx Silfradent S.r.l. March 2021 age 18 of 28
Please note!
Never use abrasive detergents
CAUTION!
ay attention that the liquid does not leak in the equipment, during cleaning or disinfection.
Never use flammable products to clean the device or its accessories.
Never carry out any maintenance or cleaning without removing the power cord.
Cleaning of the Centrifuge
The cleaning of the external surface of the centrifuge
can be performed with a soft cloth moistened with wa-
ter and / or mild detergent.
The enclosure is not waterproof, liquid may penetrate
during cleaning.
Never use abrasive products on the outer surface of
the machine or on the inner surface of the rotor cham-
ber, could be scratched.
The Centrifuge is produced with plastic materials and
stainless steel, it can be cleaned following the
procedures used in the doctor's office or in the clinic
where it is used.
Disinfecting the Centrifuge
The disinfection of the rotor chamber can be per-
formed with alcohol solutions respecting the instruc-
tions of the manufacturer of the disinfectant. The pro-
cess is explained in the instructions of each product.
On the market there are disinfectants with different
concentrations, below we listed the maximum concen-
trations of the elements of the preparations tested and
deemed acceptable.
Attenzione a non superare i livelli indicati:
 Ethanol 96%
 ropanol
 Glutaraldehyde 25%
 Ethyl hexanol
 Formaldehyde solution
 =max 40g/100g desinf.
 =max 35g/100g desinf.
 =max 75mg/100g desinf.
 =max 10mg/100g desinf.
 =max 10mg/100g desinf.
Please note.
Silfradent S.r.l. accepts no responsibility for preparations that are different or in a greater concentration
than the above indications.
Sterilization of the Centrifuge
The tubes-holders can be removed from the rotor and
sterilized in autoclave; they are manufactured in Tef-
lon
®
.
Cleaning of Accessories
All reusable components of the KITs have their own
maintenance procedures; however, it is important to
put emphasis on the importance of sterility of the ma-
terials used in the process of preparing and using the
CGF. Immediately after use on the patient, reusable in-
struments must be disinfected by placing them in solu-
tions with recognized effectiveness even on HIV, to re-
duce the risk of infection on personnel.
It is therefore important to avoid "dry out" the residues
of the intervention on instruments to avoid compromis-
ing the effectiveness of disinfection and sterilization
and to prevent corrosion on the instruments.
Many of the products used have corrosive effects on
the patient, it would be appropriate to remove them as
soon as possible by the tools.
Residues of disinfectants on surfaces can be removed
with neutral cleaners.
The instruments that can be disassembled, or other-
wise articulated, must be opened so that the disinfect-
ant can go in contact with all their parts.
The products for pre-disinfection must be a combina-
tion of disinfectant and cleanser, in no case, the liquid
must be for example saline solution because the con-
tact with the tools could leads to corrosion or formation
of rust.
After decontamination, instruments must be rinsed
with running water and resistant residues can be re-
moved using brushes with bristles of nylon or nylon-
based sponges.
Avoid the abrasive cleaners and excessive manual pres-
sure.
ay close attention not to bump or drop tools.
Use non-corrosive detergents, preferably enzymatic
nature.
Cleaning with ultrasounds is particularly effective in re-
moving stubborn dirt, however, requires special atten-
tion because the tools placed close to one another and
containers too loaded can cause scratches on the in-
struments.
After being dried the instruments must be immersed in
a disinfectant solution different from that used imme-
diately after patient use.
After that time necessary for disinfection is passed,
should be rinsed with demineralized water, decontam-
inated, and dried immediately to avoid stain.

FT 01-MUE-MEDIFUGE_Rev10.docx Silfradent S.r.l. March 2021 age 19 of 28
Sterilization of Accessories
The next phase is the packaging that has the purpose
to maintain the sterility of the instruments until their
use.
The packaging material most widely used are bags or
rolls made with film of paper and plastic materials for
autoclave,
Do not put too many tools in the bags, so as to leave
enough space between them, and effect a smooth pas-
sage of the steam.
The sterilization system recommended is with the sat-
urated steam autoclave. The recommended steriliza-
tion cycles with saturated steam autoclaves with frac-
tionated vacuum are:
 134°C, exposure time of 7 minutes and pressure
2.1 bars or
 121°C, exposure time of 15 minutes and pressure
1.1 bars.
Exposure times refer to the machine in the regime of
temperature and pressure with values already
achieved.
It is to emphasize the importance of the drying cycle
for wrapped instruments, because if it is not done
properly could compromise the integrity of the instru-
ment triggering corrosion, and altering the mainte-
nance of sterility same because any remaining water,
could give rise to the formation of bacteria, which
would put the doctor in condition of transmit any infec-
tions to the patient without his knowledge.
Warning!
For the protection of personnel, all procedures for decontamination and cleaning of instruments must
be performed using appropriate personal protective equipment.
Reusable instruments used for cleaning must be cleaned, disinfected and sterilized after use.
Please note:
Never use metal brushes or sponges as these will damage the instruments.
Maintenance of the Centrifuge
The lid of the rotor must be intact and remain locked
with the latch when closed.
Before use, always check that rotor assembly is
properly fixed to the motor shaft and does not cause
vibration.
A slight vibration during the acceleration phase is nor-
mal.
Every two years, call technical service to check the
electrical implant.
Caution!
Before use always check that the enclosure of the MEDIFUGE CGF is intact and they are no accessible
electric parts
When enclosure is damaged contact customer service.
The power cord must not have incisions or damage that may result in a risk of electric shock
Technical Support
MEDIFUGE CGF technical support is provided by
Silfradent S.r.l. In case of technical problems, the
equipment must be either repaired by Silfradent ’s
technicians or sent back to the manufacturer.
In your request, please indicate the name and code of
the device and its serial number, found on the data la-
bel on the back of the console (fig. 3-2).
When the MEDIFUGE CGF is returned to the Manu-
facturer always send all parts to allow full verification
of the functionality.
On request of technical personnel Silfradent will pro-
vide all the technical information and spare parts re-
quired for repair the device
fig. 3-2 data label location

FT 01-MUE-MEDIFUGE_Rev10.docx Silfradent S.r.l. March 2021 age 20 of 28
Re oving the Rotor
fig. 3-3 unscrew knob
fig. 3-4 extract the rotor
To re ove the rotor:
Keep locked the rotor with a hand
Unscrew the knob over the rotor (fig. 3-3).
Remove the rotor by pulling it upwards (fig. 3-4).
To replace the rotor:
Insert the rotor until it leans at the bottom.
Lock the rotor.
securely tighten the knob
Replace ent of the UV La p
fig. 3-5 re oval of cover of the la p fig. 3-6 re oval of the la p
To replace the UV la p
Loosen the screws and remove the metal plate in the back of MEDIFUGE CGF as shown in fig. 3 5
ull the UV lamp in the direction indicated by the arrow in fig. 3 6
Insert the new UV lamp and press so as to fully insert the base
be careful not to dirty the glass of the lamp.
Replace the cover and fasten the two screws.
Manual opening of the lid
Warning!
Always, before manually open the lid:
switch off the machine
detach power cord
and wait for rotor stopped.