Silfradent MEDIFUGE CGF User manual

FT 01-MUE-MEDIFUGE_Rev10.docx Silfradent S.r.l. March 2021 age 1 of 28
ENGLISH
USER MANUAL
MEDIFUGE CGF
MEDIFUGE CGF

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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.