Giotto - Ope Man Rev 1.0 Eng

Automatic Blood Components Extractor
Instruction and Maintenance Manual
Man. Rev. 1.0

Delcon s.r.l.
Via Matteucci 25/27
20043 Arcore (MI) +39-039617670 Fax +39-039617677
business e-mail: info@delcon.it
service e-mail: service@delcon.it
Website: www.delcon.it
For assistance or additional purchases, contact us at the above.
Quality System in conformity with UNI EN ISO 9001:2000, UNI EN ISO13485:2004
Manufacturer’s Responsibility
The instructions may contain a declaration of responsibility regarding safety and correct use of this device
only if:
the operations of assembly, setting, change, and repair must be performed by authorised personnel.
the electrical installation has been carried out in conformity with the instructions.
the device is used in accordance with this manual.
COPYRIGHT & NOTES

All rights reserved. No part of this document is to be reproduced, stored, or transmitted in any form without
the prior written permission of Delcon s.r.l. Despite every care being adopted during preparation of the
document Delcon s.r.l. shall not assume any responsibility for atrocities or negligence. Nor shall it assume
any responsibility for damages caused by use of the information contained herein. These same rights are
reserved for any person(s) or company involved in the creation and production of this manual. All trademarks
mentioned in this manual are property of the respective companies.
Man. Rev. 1.0 Page 2 of 44

INDEX
Section Description
Special warnings
Environmental risks and disposal
Warranty
Symbols and conventions
1 Introduction and use
2 Description
3 Installation
4 Separation Programs
5 Control Menu
6 How to change a Program
7 How to load the bags
8 Warnings, Alarms and Anomalies
9 Maintenance
10 Technical particulars

SPECIAL WARNINGS
CAUTION!
Before using the equipment, read this manual carefully.
This instrument is not designed for use in the presence of flammable mixtures, such as anaesthetics, oxygen,
or nitrous oxide with air.
Avoid water or other liquids from entering the equipment: this can cause short circuits and corrosion with
subsequent damages.
Before cleaning or overhauling GIOTTO, always disconnect the power supply cable.
GIOTTO must only be used for the purposes for which it is designed, as described in this manual.
Delcon s.r.l. shall not assume any responsibility in the following cases:
- Any use of GIOTTO different from those described in this manual.
- Damages to the operator or patient due to incorrect installation, use, or maintenance or carried out by
personnel not authorised by Delcon s.r.l.
- Electrical or mechanical changes carried out during or after installation and not authorised by Delcon s.r.l.
- Use of the press system for purposes different from those indicated in this manual.
- Improper use of the sealer heads (for ex. Sealing plastic materials other than the bag’s tube).
- Improper use of the optical systems for any purpose different then the one written in this manual.
Only personnel authorised by Delcon s.r.l are authorised to remove the machine’s exterior safety
guards and carry out maintenance .
WARNINGS FOR STAFF SAFETY
GIOTTO can be dangerous should you fail to take into consideration several precautions for use:
a. Never insert anything other than a disposable bag for storing blood or its derivatives inside
the press system.
b. Before inserting a bag containing blood or its derivatives inside the GIOTTO press system,
make sure the bag is intact: never process bags that show signs of damage, it is dangerous
for you and the machine.
c. Watch your fingers: both press systems (main and optional side systems) can generate such
a force that can crush fingers. While GIOTTO is switched ON, never insert your hands or
fingers between the press plates.
d. The machine weighs approx. 35Kg: never attempt to move the machine alone, you may
damage your spine and drop the machine! At least two people are required and use the
special handles on the base of the machine: one hand on the handle and the other on top to
counterbalance the weight.
ELECTROMAGNETIC EMMISION WARNINGS
Manufacturer’s guide and declaration – Electromagnetic emissions
The GIOTTO automatic blood component extractor can be used in electromagnetic environments as
specified on the following page. The customer or user of the GIOTTO automatic blood component extractor
must make sure the equipment is used in this environment.

SPECIAL WARNINGS
Guide to the electromagnetic

Emissions Test Compliance environment
Group 1 The GIOTTO automatic blood
Emissions Radiated /Conducted component extractor uses RF
CISPR11 energy only for the internal
functioning of the equipment itself.
Therefore the RF emissions are
very low and do not cause
interference when near any
electronic equipment.
Emissions Radiated /Conducted Class [B] The GIOTTO automatic blood
CISPR11 component extractor is suitable for
Harmonics Class [A] use in all environments, including
IEC/EN 61000-3-2 domestic environments and those
Voltage fluctuations and flicker [Meets] connected directly to the national
IEC/EN 61000-3-3 electricity network that supplies
power to buildings for domestic
purposes.
Manufacturer’s Guide and Declaration – Electromagnetic Immunity
The GIOTTO automatic blood component extractor can be used in electromagnetic environments specified
here below. The customer or user of the GIOTTO automatic blood component extractor must make sure that
the equipment is used in such environment.
Guide to the electromagnetic
Emission Test Compliance environment
Electrostatic discharge immunity ±6kV contact All floors must be wood, cement, or
(ESD) ±8kV air ceramic. If the floor is covered in
IEC/EN61000-4-2 synthetic materials, the relative
humidity should be a maximum of
30%.
Electrical fast transient immunity ±2kV power The power supply should be typical
IEC/EN61000-4-4 of a business or hospital
environment.
Surge immunity ±1kV differential The power supply should be typical
IEC/EN61000-4-5 of a business or hospital
environment.
Voltage dips, Short Interruptions <5%UT for 0.5 cycle The power supply should be typical
and Voltage Variations 40%UT for 05 cycle of a business or hospital
IEC/EN61000-4-11 70%UT for 25 cycle environment. If the user of the
<5%UT GIOTTO automatic blood
for 5 sec component extractor requires the
equipment to operate continuously,
it is advisable to use it under
uninterruptible power supplies.
Pulse Magnetic Field 3A/m The magnetic field should be
IEC/EN61000-4-8 typical of a business or hospital
environment.
Immunity to Conducted 3Vrms 150kHz to 80MHz (for --
Disturbances equipment that is not life-
IEC/EN61000-4-6 supporting)
Radiated Immunity 3V/m 80MHz to 2.5GHz (for --
IEC/EN61000-4-3 equipment that is not life-
equipment)
Note UT is the electric voltage value

ENVIRONMENTAL RISKS AND DISPOSAL
GIOTTO contains materials, which at the end of the working life of the apparatus, must be disposed at one of
the recycling centres nominated by your Local National Health Department or as specified by the laws in
force.
In particular, the apparatus contains the following materials:
- Iron
- Copper
- Aluminium
- Non-biodegradable plastics
- Fibre glass for printed circuits
- Ferrite
- Lithium batteries
Delcon S.r.l. shall not be chargeable for disposal of the apparatus at the end of its working life, just as it not
chargeable for any costs regarding machine disposal.
In line with EU Directive 2002/96/EC for waste electrical and electronic equipment (WEEE),
this electrical product must not be disposed of as unsorted municipal waste. Please dispose
of this product by returning it to the point of sale or to your local municipal collection point for
recycling.

WARRANTY
Delcon S.r.l. provides a 24-month guarantee for GIOTTO from the date of sale. The guarantee is free only at
Delcon premises, spare parts, and labour included. The guarantee only covers faulty parts during the validity
period. GIOTTO is not covered by the guarantee for damages caused by negligence, tampering, or any
intervention that is not authorised by Delcon S.r.l. The LCD and the load cell for the scales are not covered
by the guarantee.
To use the guarantee service, the customer must abide by the following rules:
1. GIOTTO should be delivered for repair to Delcon S.r.l. or to your nearest authorised Technical
Assistance Centre and in its original packaging. Any damages suffered during transport with
unoriginal packaging are not covered by the guarantee.
2. Deliveries are chargeable to the customer.
3. GIOTTO must be accompanied by a copy of the invoice stating the purchase date and by a
detailed account of the fault.
For further information on the guarantee procedure, contact Delcon S.r.l.

SYMBOLS AND CONVENTIONS
The list below is a summary of the symbols and conventions used in this manual.
Please read carefully
Watch your hands, risk of crushing.
Earth
Type B apparatus
Before use the equipment, read carefully the instruction
PL Plasma
PRP Platelet-Rich Plasma
RP Recovered Plasma
PPP Platelet-Poor Plasma
RBC Red Blood Cell Concentrate or Erythrocyte
PdRBC Partially Leukoreduced Red Blood Cell Concentrate
BC Buffy-Coat
PLTS or PC Platelet Concentrate
pdPC Partially Leukoreduced Platelet Concentrate
RL Residual Leukocytes
Cryo Cryoprecipitated (Factor VIII)
WB Whole Blood
MTH Mother Bag and therefore the bag inside the main press.
SAG-M Solution for Erythrocyte
T&B or TAB Top and Bottom bags
DMS Data Management Software (GIOTTO programming software to install

in the computer in Windows 2000 or XP)
OPT1 Upper Main Optical Sensor
OPT2 One of the optical sensors on the main press.

SECTION 1 INTRODUCTION & USE
1.1 Purpose of use

GIOTTO must only be used with sterile disposable bags for storing blood and its derivatives, in
compliance with International Standard ISO 3826 and European Regulation 93/42 MDD.
GIOTTO is an apparatus used to transfer haematic/blood fractions from a main bag to several, duly
centrifuged, satellite bags.
1.2 A few concepts about the preparation of blood components
Irrespective of the choice of technology for the preparation of any component, the principle that allows you to
reach the final result is the same: a quick and controlled sedimentation of whole blood through centrifugation.
The centrifuge machines for bags are used to separate the blood components into fractions. Following
suitable centrifugation curves and knowledge of the average blood component density it is possible to
prepare accurate layers of different products inside common blood storage bags.
EXAMPLE
Density 450 ml of whole blood
Plasma 1.026 g/ml centrifuged for 10
Platelets 1.058 g/ml minutes at 3800 g.
Monocytes 1.062 g/ml
Lymphocytes 1.070 g/ml
Basophils 1.075 g/ml
Neutrophils 1.082 g/ml
Eosinophils 1.087 g/ml
Erythrocytes 1.100 g/ml
GIOTTO is a machine that, after the bags of WB are duly centrifuged, automatically and quickly prepares
most blood components using the most common blood bags available on the market, both standard and Top
& Bottom types. By means of the controlled movement of a press used to press the bag of centrifuged whole
blood, a network of clamps fitted with sealer heads, two or more weighing scales (depends by the chosen
configuration) and a series of optical sensors, GIOTTO automatically and accurately extracts and transfers
blood fractions from the main bag to the satellite bags and in some cases vice versa. Even SAG-M, if
available, can be transferred. This manual also describes the many other possibilities this system offers.
The best performance in terms of component quality and quantity can only be reached by means of an
optimum relation between the centrifugation curve and the GIOTTO settings: two closely connected
parameters.
The true means to obtain good results are the acceleration in total gravity applied to the bags by the
centrifugation, together with good manual ability when handling the bags and good management of the
GIOTTO machine.
As a general indication for the most common preparations using 450ml bags, the following page summarises
some figures regarding the G-forces of centrifugation applicable to whole blood:

SECTION 1 INTRODUCTION & USE
PROCEDURE VALUE IN Gxs (integral force or AFC)

st
PRP 1 centrifugation with standard bag 550,000
nd
PRP 2 centrifugation 3,000,000
st
BC 1 centrifugation with standard bag 1,500,000
nd
BC 2 centrifugation with single BC standard bag 100,000
nd
BC 2 centrifugation POOL of 3 BC 180,000
nd
BC 2 centrifugation POOL of 6 BC 240,000
st
BC 1 centrifugation Top & Bottom bag 2,700,000
The above figures is only approximate, but useful for defining a starting point. Some centrifuge machines can
automatically calculate the total integral force, in this way you can use the table above as a standard to which
you can make appropriate variations. It is always advisable to have an average acceleration and a very low
deceleration, irrespective of the type of centrifuge, to avoid the re-suspension or remixing of layers.
The main components that can be prepared with GIOTTO are as follows:
After the first centrifugation of WB:
PRODUCTS FROM PLASMA

1. Platelet-poor plasma (PPP)
2. Plasma from filtered whole blood (PPP)
3. Platelet-rich plasma (PRP)
4. Filtered platelet-rich plasma (PRP)
PRODUCTS FROM BUFFY COAT

1. Dry Buffy Coat
2. Buffy Coat with Platelets
3. Buffy Coat with Platelets for subsequent preparation of PLTS from single BC.
PRODUCTS FROM RBC

1. RBC with SAG-M
2. RBC BC depleted with SAG-M
3. RBC BC depleted with added Plasma
4. RBC with SAG-M from filtered WB
After the second centrifugation of the fractions:
PRODUCTS FROM PLASMA

1. Platelet Concentrate from PRP
2. Cryoprecipitate
PRODUCTS FROM BUFFY COAT

1. Platelet Concentrate from single Buffy Coat unit
2. Platelet Concentrate from pool of Buffy Coat
PRODUCTS FROM RBC

1. Removal of the washing solution from washed erythrocytes concentrate
In addition, it is also possible to use GIOTTO to:

a. Share a component stored in one bag, in smaller volumes in up to three bags. This function is useful
for example when preparing paediatric doses.
b. Remove excess air from one bag and transfer it to another bag.

SECTION 2 DESCRIPTION
2.1 Description of GIOTTO
GIOTTO – automatic blood component extractor
GIOTTO is an automatic extractor for preparing blood components from centrifuged whole blood in
disposable blood bags in conformity with International Standard ISO 3826 and Regulation 93/42MDD. It can
also prepare high quality blood components with any type of blood bag available on the market, both the
conventional and Top & Bottom types.
Different separation programs are pre-loaded in the system to meet most preparations requested by Blood
Components Laboratories. The programs with their relevant settings are stored in the memory even after the
machine has been switched off and can be partially changed directly by GIOTTO or completely changed via
computer (if a data network is available with the specific DMS software installed, see the next pages for
details about the DMS).
The back panel of GIOTTO includes the following interfaces: serial port for barcode reader, port for data
network, port for additional external scales, port for an additional external sealer.
A dedicated microprocessor constantly controls GIOTTO and in particular, the press, which is the
operational heart. The press is controlled by the system during the entire separation process as regards
movement speed, position, internal bag pressure, and type of movement that can be with parallel levels or
with the exclusive inclined level system. The press is electronically controlled and operated, does not
require compressed air, is extremely quiet, and uniformly controls the pressure applied inside the blood bag
without producing the re-suspension of product layers from the centrifugation process.
GIOTTO is fitted with a series of optical sensors situated on the main press (OPT2) to identify the PL –
BC interface, as well as an additional optical sensor (OPT1) situated on the tube near the main bag,
necessary to completely remove air and/or PL should this be necessary.
GIOTTO can be fitted with an additional side press system (see optionals) with accessory scales. The
exclusivity of this option is extremely useful for speeding-up certain applications such as for example
transferring SAGM to conventional bags or for some processing that requires the use of in-line filters.
At the end of each extraction, GIOTTO automatically, or after confirmation by the operator, seals the
connection tubes, arranging them with a centre break line for easy separation. There are five sealers
that can be enabled or disabled one by one, to seal automatically, manually or not to seal at all with each
specific program.
GIOTTO Standard Equipment:

- main press electronically controlled and powered with parallel moving or with the exclusive slanted
movement.
o adjustable pressure on the bag during separation,
o adjustable press speed for the set N profiles,
o fine adjustment of the press position along the entire stroke for the set N profiles.
- five programmable sealer clamps, one of which has proportional control for better accuracy
during processing of TOP & BOTTOM bags.
- Two weighing scales to read the weights of all the components:
o vertical: for the PL, PLTS, SAGM.
o side: for the BC, RBC in the preparations of T&B or the PRP in certain applications.
o each of the two scales can be used, by choice, to read the weight of the preparation left
inside the press (RBC, BC dry or wet). An optional third weighing scale is available to
install inside the press to automatically read the weight a fourth scale with the option
GIO.DB.30 and a fifth external scale with tray for RBC in the preparations of T&B bags
GIO.DB.40. In both cases, the management software automatically memorises the weight so
it can then be sent to the DMS.
- LCD graphic display white – blue backlighted with guided menu and membrane keyboard.
- Separation programs. GIOTTO is supplied with 16 separation programs as standard.
Each of these programs can be partially changed directly by GIOTTO or completely changed via
computer if a network is available and the DMS is installed.

A FUNCTIONAL DESCRIPTION OF GIOTTO:
SYSTEM
1. compatible with all bags available on the market.
2. includes 16 preloaded separation programs with the possibility of generating and storing additional
programs up to a maximum of 40.
3. continuous control of the internal bag pressure and outflow speed.
4. intelligent system for simultaneous extraction of PL and RBC during preparation of T&B bags with
accurate control to keep the BC in the desired position.
5. automatic regulation of the final BC volume to leave in the bag during preparation of T&B bags.
6. automatic excess air extraction (for example: for the preparation of air-free PL).
7. five programmable and independent sealers with correct tube position control and easy-to-remove
protective cover without tools.
8. eight optical sensors on the main press (OPT2) in addition to a ninth external sensor (OPT1), all with
independent adjustable sensitivity.
9. automatic system to calculate the optical zero point for all the sensors. Used to keep the extraction
processes consistent independently from the type of bag used or the colour of the tube.
10. GIOTTO can operate autonomously without the need of a computer or with network data
management in Windows® (2000 o XP).
PROCESS CONTROL
1. GIOTTO comes with comprehensive and intuitive management software: DMS or Data
Management Software (option: code GIO.DB.10). With DMS, you can customise existing
separation programs or generate new ones, while directly from the machine you can only make
certain changes to existing programs stored in the memory. You can store up to 40 programs in each
GIOTTO machine. A new program can easily be generated in the computer via DMS and then
transferred to any system in your network. Each new separation program has an OPEN type
preparation and only requires a minimum understanding of computers and data network
management.
2. A separation program is made up of a DESCRIPTION, a HEAD, a MAP of weights, a barcode
FILTER system, and a certain number of operational PHASES.
a. The HEAD defines how and which parts of GIOTTO to use from the start to the end of the
program, for example: whether to use the press with parallel level movement or inclined level
movement.
b. The MAP of weights defines the composition of the final weights that GIOTTO must store.
c. The barcode FILTERS define which label to read for that PRG and, if necessary, whether to
apply suitability filters to allow the separation to continue.
d. A PHASE is a complete sequence of instructions given to the machine to move one or more
components from one bag to another. A program can include one or more PHASES
according to the type of preparation. GIOTTO has four types of independent PHASES, but
each one can be interlinked.
i. PHASE A: extraction of a single component by means of the press.
ii. PHASE B: transfer of a single component by weight or by means of the additional
press (if installed).
iii. PHASE C: differential extraction of predetermined weight by the press (typically for
preparing PLTS from PRP after a second centrifugation).
iv. PHASE D: simultaneous extraction of two components (typically only for T&B bags)
by means of the press.
3. The first PHASE of the PRG starts automatically after the START. The end of a PHASE is instead
linked to one or more events, the first one that occurs. When one of these events occurs, the PHASE
will end and if there is a next phase this one will then start. When all program PHASES have ended,
the separation program will also end. Typical events that can cause a PHASE to end are:
a. The main sensor detects the approach of a new product that could be PL if it is drawing out
air or BC if it is extracting PL.
b. The optical sensor on the press (if enabled) switches on because of the approach of BC.
c. The weighing scale enabled for that procedure reaches the weight preset by the program.
d. The press reaches the STOP position for that program.
DATA MANAGEMENT AND ONBOARD SOFTWARE

1. If GIOTTO is not connected to the computer, it will be possible to manually measure the weights of
the blood components at the end of the separation, which will be displayed on screen.
2. When GIOTTO is connected to the computer and DMS is running, it will be very easy to transfer the
data available for each separation as well as organise new programs, see option code: GIO.DB.10
for further details.
3. It is not possible to create new separation programs from the machine you will need the DMS.
4. GIOTTO will not record the separation data if the DATA NETWORK is disabled (see DMS Manual).
OPTIONAL ACCESSORIES
SOFTWARE
Code: GIO.DB.10
- DMS: Data Management Software. DMS is a software with bi-directional communication to
remotely manage the machines. This software comes with a CD-Rom and includes a NETWORK
ADAPTER for computer connection (a private GIOTTO network cannot be interfaced with existing
LAN networks). DMS must be installed on a computer with Windows® 2000 o XP with at least one
RS232 port and a free USB port (computer not included). Via the DMS you can carry out the
following operations:
o change existing programs in the network of GIOTTO machine(s),
o generate new separation programs and transfer them to the machines,
o update the system software (option reserved for the technical service),
o download, process and print out data from the network of GIOTTO machine(s) for each
individual separation (printer not included, a manual printing procedure is required).
- Data transferred from GIOTTO to DMS for each separation:
1. Serial number of the GIOTTO machine that carried out the separation
2. Description of the program carried out
3. Number of the program carried out
4. Net weight of Plasma extracted in satellite bag 1
5. Net weight of Buffy Coat
6. Net weight of Whole Blood
7. Net weight of PL transferred in BC
8. Net weight of SAG-M transferred in RBC
9. Net weight of PL transferred in RBC
10. Net weight of PL transferred in satellite bag 2
11. Net weight of PLTS concentrate
12. Net weight of RBC
13. Separation data
14. Separation time
15. Separation duration
16. Error code, if present
17. Operator barcode label
18. First bar code label: ID1
19. Second bar code label: ID2
20. Third bar code label: ID3
21. Fourth bar code label: ID4
! IMPORTANT NOTES about the data and how to manage it !
- The list above shows the all the data available from GIOTTO.
- The completion of these fields is based on the job in-progress; therefore, they are not all active and
available.
- Via the DMS, it is possible to enable or disable data and change the saving sequence. This feature is
extremely useful to save GIOTTO data in a suitable TXT file, in order to make data easily available
when interfacing with existing management software (see DMS Manual).

HARDWARE
Code: GIO.DB.20
Additional scale for the main press. To measure the weight of the bag inside the press; it is necessary to
set the tare of the empty bag. The weight is only read when the press is not pressing the bag. Based on the
type of procedure it is possible to read the weight of WB, PLTS, or BC. This option must be purchased at the
same time as the GIOTTO machine.
Code: GIO.DB.30
Additional left press with incorporated scale. Can be used for certain applications, it is suitable for making
the separation process quicker, such as for example quick transfer of SAGM or processing bags with in-line
filters. This option must be purchased at the same time as the GIOTTO machine.
Code: GIO.DB.40
External tray scale. To connect to the auxiliary port situated at the back. Can be used to measure the weight
of any one of the blood components, before, during or after separation.
Code: GIO.DB.50
Additional handgun sealer. Supplied with a 2m long coaxial cable and connects to the specially provided
port at the back of the machine. Used to seal standard PVC tubes.
Code: GIO.DB.60
Barcode label CCD Reader. Standard reader with handle, software, and its own cable. Can read any type of
barcode.
Code: GIO.DB.70
Network cable. Necessary to connect each individual GIOTTO machine to the network. You must buy
one for each GIOTTO machine (see diagram below).
NETWORK CONNECTION DIAGRAM
Computer
with DMS
USB installed
GIOTTO GIOTTO GIOTTO RS232

no…
Network
adapter 2
1 1
1
NOTES:
A. A network cable must be purchased separately for each individual GIOTTO machine you wish to
connect. See code GIO.DB.70 (1): purchase one for each GIOTTO machine you wish to connect to
the network.
B. The network adapter (2) is supplied with DMS code GIO.DB.10. Purchase one DMS for each network
you wish to activate and therefore one for each computer you wish to connect to your GIOTTO
machine(s).

DESCRIPTION OF PARTS
Vertical scale rod

(Scale 1)
Upper sealer clamp
Sealer clamp with

proportional control.
Main sensor (OPT1) Upper sealer clamp

Optional press scale Clamp ON LEDs
(Scale 3)
Side scale (Scale 2).
Optional side press
with integrated Keyboard and display
scale(Scale 4).
Press compartment
Press sensors (OPT2) door.
Barcode reader Top & Bottom Clamp
2.1 Keyboard
The keyboard has six multifunction keys:
1. PAUSE: to pause the procedure
2. SEAL: to manually enable the sealer clamps from

main menu.
3. ESC: to exit the function or procedure in progress.
4. UP Arrow: to move upward for Menu selection.
5. DOWN Arrow: to move downward for Menu selection.
6. ENTER: to confirm the selected parameter or function,

start/continue a separation procedure.

Clamps and optical sensor panel
- Includes six LEDs, five of which are numbered for

each clamp and one is for the main optical
sensor.
- The LED have three positions: OFF, ON green,
ON red.
- When the program is started, the LED
corresponding to the clamps enabled for that
specific program will light-up RED. The tubes
should be inserted appropriately, inside the
devices indicated by the LED.
- When the tubes are correctly placed inside the
devices, the corresponding LEDs will light-up
GREEN.
2.2 Display
LCD display with BLUE – WHITE graphics and backlighted. All the menus are visible on screen. Follow the
instructions to easily access work protocols and use or program the machine.
2.3 Back panel
The back panel is fitted with the following elements:

- Main switch with safety fuses and voltage selector
- Network connectors
- Additional external scale connector
- Radio frequency output connector for optional sealer handgun
- Connector for barcode reader
- Machine rating plate.
2.4 Optical sensors
GIOTTO is equipped with eight optical sensors situated vertically on the main press (OPT2) in addition to a
ninth sensor (OPT1) situated on the upper part of the machine near clamp number 3.
Press sensors OPT2.

For each program, it is possible to set any of the eight sensors to start when the buffy coat is approaching,
also determining sensitivity: number 1 is the first at the top. In this way, you can set the exact point at which to
stop the buffy coat, or use the sensor to determine the moment in which the press must switch to the next
velocity profile. You can also define the sensitivity of each sensor (1 – 999).
Upper main sensor OPT1

This sensor can also be programmed for each type of separation. It can function in connection with the press
sensors or autonomously. Its function is to identify the approach of a fraction different from the previous one
and therefore detect a change in the state of the fluid flowing inside the tube: from air to plasma or from
plasma to buffy coat. There is a series of red-coloured LEDs on the cover of the main sensor that
automatically light up when the separation has ended or when an error occurs. The sensitivity of the sensor
can be programmed from 1 to 999.
2.5 Sealer Clamps
GIOTTO is equipped with five sealer clamps, one of which has proportional control. These clamps are
electromechanical components with a double function: to close and /or seal tubes. According to the program
in progress, the clamps can be activated to automatically or manually seal at the end of processing. Each
clamp has a tube control sensor that checks the correct position of the tube: this avoids performing
incorrect operations due to wrongly inserted tubes.

Clamp no.3 situated immediately after the upper optical sensor (OPT1)is a proportional movement
clamp. This clamp is very useful, above all when working with TOP & BOTTOM bags. The proportional
regulation allows to system to accurately check the position of the buffy coat, regulating the upper outflow
from the T&B bag. Clamp no.3 is slower compared to the other clamps, and therefore should not be used to
quickly close a tube.
2.6 Scales
Electronic scales are used to weigh the blood components. These scales, although delicate pieces of
equipment are designed to withstand forces up to 2.5Kg, this value should guarantee a good safety margin.
The weight read by the scales is the net weight of the blood components in question unless stated
otherwise in the program PHASES.
2.7 Press
The GIOTTO press has electronic control and moves by PHASES connected according to the program in
progress. Inside each one of these PHASES, it is possible to set the velocity profile of the press (up to 5
profiles according to the PHASE) to manage four essential parameters:
1. movement velocity (0-120 rpm)

2. internal bag pressure (10 – 600 millibar)
3. final press position (0-650 in tenths of a millimetre where 0 = completely closed)
4. positions in which to switch the velocity to the next profile (0-650 expressed in tenths of a millimetre)
In addition, at the start of each program, it is possible to select the type of movement and therefore whether
to use parallel levels or inclined levels. As a rule, it is advisable to use the parallel movement whereas the
inclined levels are useful for several special separations.

SECTION 3 INSTALLATION
3.1 Removing GIOTTO from its packaging
CAUTION!
GIOTTO weighs approximately 35Kg: never attempt to lift the machine alone; you may
damage your spine! Should you need to move GIOTTO, at least two people are required and
use the special extractable handles situated underneath the machine: one hand on the handle
and the other on top of the machine to counterbalance the weight.
Remove the machine carefully from its packaging with all the other parts.
Check that all machine parts are intact.
The standard GIOTTO equipment is composed of:
- Power supply cable

- Support for side scale
- Rod for vertical scale
- Operator Manual
- Any accessories if purchased.
3.2 Where to install GIOTTO
To achieve the best performance in complete safety it is important that GIOTTO is positioned on a
2
flat and stable surface, capable of supporting at least 50Kg/m . Should you have more than one
machine to install on the same table, leave enough space around the machines so you can work
easily.
Never position GIOTTO on an unstable surface. Vibrations can compromise the weight
readings of the weighing scales and the machine could fall with consequent danger to staff.
Never position GIOTTO too near the centrifugal machines. The vibrations generated by the
large centrifugal machines for the bags can create operational problems.
It is advisable to position GIOTTO in a dry place, free from humidity and away from direct sunlight,
radiators or other heat sources.
3.3 Installing the parts supplied
Follow the instructions described in this paragraph:

• Insert the vertical rod that holds the bags in the threaded hole on top of the machine and screw it
down. If necessary turn the upper support until the word: Plasma is to the left and SAG-M is to
the right.
• Install the side scale support, screw down the two rods in the corresponding threaded holes.
Firmly, but carefully tighten the two upper security dowels, taking care that the transparent pan is
at least 2cm from the side panel.
3.4 Switching on GIOTTO
Before everything else, check that the mains are earth wired correctly. If the earth cable is
damaged this may reduce effectiveness, NEVER switch on the machine and resolve the
problem.

SECTION 3 INSTALLATION
CAUTION!
GIOTTO requires a supply voltage of 230V or 115V 50/60Hz +/-10% !
At the factory, the voltage is set at 230V. Check that the supply voltage is the same as the
voltage selected with the voltage selector situated at the back of the machine before you
switch the machine on.
Make sure the main switch at the back of the machine is switched OFF before you connect the
machine to the mains.
With no bags inserted in GIOTTO, with the door firmly closed and without touching the scales, insert
the power supply cable and switch on the machine using the main switch at the back.
GIOTTO will start the initialisation and calibration procedure of all its components (approx. 1 minute)
At the end of this initialisation procedure, the GIOTTO screen will display:
MAIN MENU
-----------------------
< GIOTTO R: xxx >
< date and time >
< 1- Programs >
< 2- Bilances >
< 3- Settings >
< 4- Send Dato to PC >
< 5- Tech Service >
<Select: >
-----------------------
Each menu contains sub-menus relating to the selected context. The controls are intuitive and will not
be listed other than in this phase.
In order to improve the heat stability of GIOTTO and therefore the accuracy of the scale readings, it is
advisable to wait at least 30 minutes before starting any separations.
3.5 Switching off GIOTTO
You may switch off GIOTTO at any time using the main switch situated at the back.

SECTION 4 Separation programs
4.1 Standard separation procedures
GIOTTO offers several extraction possibilities based on the type of bags and the procedure you wish to
perform. As a base, 16 programs are installed that can be partly customised from the machine or completely
changed via the DMS (see DMS Manual, this requires a computer with an RS232 serial port and free USB).
Here below is a list of the 16 programs pre-installed at our factory:
EXTRACTION FROM WHOLE BLOOD TO STANDARD BAGS

st
AFTER 1 CENTRIFUGATION
DESCRIPTION OF THE BASIC PROCEDURES:
Program 1: Double bags.

Procedure:
1. Extraction of Plasma.
2. Reinsertion of Plasma by weight in WB bag (enabled or disabled) for erythrocyte
dilution.
Final result:
Plasma
Erythrocytes with BC diluted in Plasma.
Program 2: Triple bags with SAG-M.

Procedure:
1. Possibility to transfer extra Plasma (enabled or disabled) after optical sensors
detect BC.
2. Transfer of SAG-M in the erythrocytes.
Final result:
Plasma with or without platelets.
Erythrocytes with BC diluted in SAG-M.
Possibility of subsequent processing of PLTS from PRP.
Possibility of subsequent processing of cryoprecipitations.
Program 3: Triple bags with SAG-M (with air removed).

Procedure:
1. Extraction of air from WB bag to SAG-M bag.
2. Continues as per PROGRAM 2.
Final result:
Plasma with or without platelets in air-free bags.

Program 4: Triple bags with SAG-M (Plasma of predetermined weight)
Procedure:
1. Extraction of Plasma by weight (stops at xx grams).
2. Extraction will stop before the set weight is reached if the optical sensors detect
the approach of BC.
3. Transfer of SAG-M.
Final result:
Plasma
Program 5: Triple bags with SAG-M (Plasma of predetermined weight + air removal)
Procedure:
1. Extraction of air from WB bag and transfer to SAG-M bag.
Final result:
Plasma in an air-free bag.
Program 6: Triple bags without SAG-M.

Procedure:
2. Extraction of dry BC by weight.
3. Return by weight of Plasma in WB for erythrocyte dilution.
Final result:
Plasma
Erythrocytes without BC diluted in Plasma.
Program 7: Quadruple bags with Plasma free BC.

Procedure:
2. Extraction of dry BC or with platelets.
3. Possibility to return Plasma to WB bag for line washing by weight.
4. Transfer of SAG-M in erythrocytes.
Final result:
Plasma with or without platelets.
BC with or without platelets.
Erythrocytes stripped of BC and diluted in SAG-M.
Possibility of subsequent processing of PLTS from BC pool.

Program 8: Quadruple bags with Plasma free BC (with air removed).
Procedure:
1. Extraction of air from WB bag and transfer to SAG-M bag.
Final result:
As per PROGRAM 7 but with Plasma in air-free bags.
Program 9: Quadruple bags with BC and added Plasma.

Procedure:
1. Extraction of plasma.
2. Extraction of BC by weight.
3. Dilution of BC with Plasma by weight.
4. Possibility to return Plasma to WB bag for line washing by weight.
5. Transfer of SAG-M in erythrocytes.
Final result:
Plasma
BC with added Plasma.
Erythrocytes stripped of BC and diluted in SAG-M.
Possibility of subsequent processing of PLTS from single BC.
EXTRACTIONS FROM WHOLE BLOOD IN TOP & BOTTOM BAGS

st
AFTER 1 CENTRIFUGATION
Program 10: Triple T&B bags

Procedure:
1. Extraction of N g of PL.
2. Extraction of Plasma and Erythrocytes.
3. Regulation of residual BC hematocrit with sensors and press position.
4. Possibility to reinsert Plasma in WB bag (enabled or disabled) for line washing or
for further BC dilution.
Final result:
Plasma
Dry BC or with PL
Erythrocytes without BC diluted in SAG-M.
Possibility of subsequent processing of PLTS from BC pool.

Program 11: Quadruple T&B bags
Procedure:
1. Extraction of N g of PL in the satellite bag containing PLTS (after agitating the
single BC, used to wash the tube and valve: reducing RBC contamination)
2. Extraction of Plasma and erythrocytes.
3. Regulation of residual BC hematocrit in WB bag with sensors and press position.
4. Possibility to reinsert Plasma in WB bag (enabled or disabled) for line washing or
for extra BC dilution for subsequent processing of platelets from BC.
Final result
Plasma
Dry BC, with platelets, with or without added Plasma.
Erythrocytes without BC diluted in SAG-M.
Possibility of subsequent processing of PLTS from single BC or BC pool.
Possibility of subsequent processing of cryoprecipitate.
nd
EXTRACTIONS AFTER 2 CENTRIFUGATION
Program 12: Extraction by weight of Platelets from PRP or cryoprecipitate

Procedure:
1. Weighing of initial bag gross weight.
2. Automatic subtraction of the tare (tare value to be entered in advance)
3. Extraction of Plasma by weight difference.
4. Procedure ends upon reaching weight set for the PLTS or cryoprecipitate.
Final result:
Plasma
Platelet concentrate or cryoprecipitate at predetermined weight.
Program 13: Extraction of Platelets from PRP or cryoprecipitate, with press in fixed
position.
Procedure:
1. Extraction of Plasma until pre-set press position is reached.
Final result:
Plasma
Platelet concentrate or cryoprecipitate.
Program 14: Extraction of platelet concentrate from single BC (bag 100ml)

Procedure:
1. Extraction of platelet concentrate until optical sensors detect BC.
2. Possibility to transfer extra PC (enabled or disabled)
Final result:
Platelet concentrate from single BC
Dry BC
Program 15:

Program 15: Extraction of platelet concentrate from single BC (bag 450ml)

Procedure:
3. Possibility to transfer extra PC (enabled or disabled) after optical sensors detect
BC.
Final result:
Platelet concentrate from single BC
Dry BC
Program 16: Extraction of platelet concentrate from BC pool

Procedure:
5. Possibility to transfer extra PC (enabled or disabled) after optical sensors detect
BC.
Final result:
Platelet concentrate from BC pool
Dry BC
4.1.1 How to use a Program in the memory
From the main menu, select 1 – Programs and press ENTER. Use the arrows to select the Program
and press ENTER. Follow the instructions on screen.
IMPORTANT NOTES:
1. All the Programs pre-installed in our factory have the following functions disabled:
tube sealing, barcode reading, automatic sending of data to the computer, initial and
final component weighing. See Section 6.2 to enable these functions.
2. Open the breakable valves on the bags only when requested by the machine.
3. Follow the instructions on screen and do not touch the scales or the tubes during
processing.
4. If you make a mistake press PAUSE to suspend the PRG: press ESC to exit the
procedure for good or press ENTER to resume the procedure.
To change the Program parameters see Section 6.
4.1.2 How to generate a new program
It is not possible to generate a new separation program from the machine: please refer to the DATA
MANAGEMENT SOFTWARE (DMS) Manual to create a new one from scratch (sale option code
GIO.DB.10).

SECTION 5 Control Menu
5.1 How to use the control menu
Main menu:
-----------------------
< GIOTTO R: xxx >
< date and time >
< 1- Programs >
< 2- Balances >
< 3- Settings >
< 4- Send Data to PC >
< 5- Tech Service >
< Select: >
-----------------------
1. Programs: to access the programs stored in the memory to start a procedure.

2. Balances: to access the menu to use the scales manually.
3. Settings: to access the main menu for machine settings to set the language, date and time, enable
the network and change programs in the memory.
4. Send Dato to PC: to send the computer the data regarding the separations stored in the memory,
this operation is necessary if the automatic sending function is not set. This function requires the
computer switched on and the DMS enabled and ready to receive data: also refer to DMS Manual.
5. Tech Service: to access several functions pertaining exclusively to the technical service or to set the
machine to receive new configurations and/or Programs via the computer (DMS required).
NOTES:
- If the NETWORK is disabled, the machine will not record the separation data.
- Most of the main menu functions are intuitive and easy-to-understand therefore no further details are
required. However, the CHANGING PROGRAMS function does require further explanation:
please see next Section.

SECTION 6 How to change a program
6.1 Changing a Program from the GIOTTO keyboard
CAUTION!
To change a Program without any problems, you must have good knowledge of all the processing
procedures as well as the complete structure and functional logic of GIOTTO. Setting incorrect
parameters can worsen the final result or even compromise the entire procedure. Before making any
changes, carefully read the section that follows and make one change at a time, so that you can reset
the initial conditions in case the result is the opposite to the one you hoped for.
To change a Program from the INITIAL menu, use the arrows to select 3 – Settings then press ENTER to
confirm. The following window will appear:
-----------------------
< 1- Language >
< 2- Date and Time >
< 3- Enable data Net >
< 4- Change programs >
< >
<Selezione:-- -- >
<ENTER per Continuare.>
<ESC per uscire. >
-----------------------
use the arrows to select 4 – Change programs and press ENTER to confirm.
Use the arrows to identify the Program you want to change and press ENTER to confirm.
CAUTION!

From GIOTTO you can only change part of the parameters regarding a specific Program, whereas
complete access is only possible via DMS.
The parameters of a specific Program that you can change from the GIOTTO keyboard are:
- the HEAD of the PRG that determines the general functions from start to finish
- the Program PHASES (1 – n) that determine the movements of the blood components.
- the enabling of the barcode reading
To access the Program HEAD, press ENTER again.
6.2 PROGRAM HEAD
Legend: 0 = disabled, 1 = enabled, or enter a value from 1 to xxx by arrows

-----------------------
<Modify Prg Head: >
< Plate Type : - > - type of reduction plate (not supplied as standard)
< Bar Code : - > - number of bar barcode labels to read
< OP Barcode Enab.: - > - read or not read operator barcode label
< Tube Check Enab.: - > - enable tube control in the clamps + optical sensor
< Start Wei.Enab. : - > - enable component weighing before separation
< End weight Enab.: - > - enable component weighing after separation
<ENTER to Continue. >
---------------------
-----------------------
<Modify Prg Head: >
< >
< Bag Tare : --- g> - empty bag tare for initial or final weighing
< Open Clamps : - > - 1 = open clamp automatically at end of PRG
< > 0 = request confirmation before opening clamp at end
< > of PRG
< >
-----------------------

-----------------------
<Modify Prg Head: >
< >
< Automatic Sealing >
< CL1: - CL2: - > - selects and enables the sealer clamps
< CL3: - CL4: - > automatically at the end of the PRG.
< CL5: - >
< >
-----------------------
-----------------------
<Modify Prg Head: >
< >
<****Manual Sealing***>
< CL1: - CL2: - > - selects and enables the sealer clamps
< CL3: - CL4: - > after confirmation at the end of the PRG (among those
< CL5: - > that are not already set to seal automatically)
< >
-----------------------
Once you have checked and confirmed the Program HEAD, you may now access the PHASES.
CAUTION!
The sequence and number of PHASES in a Program is not fixed, but varies based on the type of
Program. From the GIOTTO machine, it is not possible to cancel or add PHASES; this can only be
performed via the DMS. There are four types of PHASES and can each be interlinked:
- Phase A: Extraction of a single component or air
- Phase B: Transfer of a single component by weight or even air if the optional side press is
installed.
- Phase C: Extraction of a component by differential weight (initial weight known)
- Phase D: Simultaneous extraction of two components (T&B processing)

6.3 DESCRIPTION OF PHASES
PHASE A: Extraction of a single component or air
This phase manages the extraction of a single component or air from the main bag to a satellite bag:
uses the main press. PHASE A: ends due to one of the following conditions, the first one that occurs in
chronological order:
1. The operator has set a fixed weight to extract and this weight has been reached
2. The main sensor OPT1, if enabled, has switched on due to the approach of BC.
3. Sensor OPT2 (Sensor selected on the press), if enabled, has switched on due to the approach of BC.
4. The press has reached the final position set in the last velocity profile of the program.
When a PHASE ends, the machine automatically proceeds to the next phase in the program, otherwise if
there are no more phases the program will end.
-----------------------
<Phase Exc. : xx > Fixed Weight = ends the PHASE when the enabled scales
< Fixed weight: - > measures the weight entered in this field (0-600)
< > First velocity profile
< V1: - D1: - > V1 = the press motor velocity in rpm (1 - 120)
< L1: - S1: - > L1 = press optical sensor enabled for end of the
< V2: - D2: - > velocity profile (1-8 of which 1 = first at the top)
< L2: - S2: - > D1= Distance between the door and press in tenths of mm to
< > end the velocity profile (0-650)
<ENTER to Continue. > S1 = sensitivity of selected press optical sensor (0-999)
-----------------------
Subsequent velocity profiles (up to 5)
follows from window above V2, L2, D2, S2 ...: repeat the same controls, but for the
following velocity profiles.
-----------------------
<Phase Exc.: xx > NOTE:
< V3: - D3: - > - The end of a velocity profile is determined by the first
< L3: - S3: - > of the following events that occur chronologically:
< V4: - D4: - > o Switched on of a LED on the press (BC intercepted)
< L4: - S4: - > o The set distance has been reached
< V5: - D5: - > - When a velocity profile ends, the machine automatically
< L5: - S5: - > moves on to the next profile.
-----------------------
-----------------------
<Phase Exc.: xx >
< T.max Phase: - > - Maximum execution time of the PHASE then alarm (5-900 sec)
< OPT1 Weight: - > - sets weight to activate the zero of the main sensor (0-200)
< OPT1 Sens_ : - > - sets sensitivity of main optical sensor (0 – 999)
< L_OPT2_OPT1: - > - press sensor that must activate at main sensor zero (0-8)
< OPT2 Sens : - > - sets sensitivity of the selected press sensor (0 – 999)
< >
-----------------------
NOTES:
1. GIOTTO is equipped with an automatic auto-zero system for the main optical sensor (OPT1). Each time
a PHASE begins that requires the use of the OPT1 sensor, the sensor’s optical zero is activated. This
serves to set at zero the optical differences among the various tubes available on the market or more
simply between different coloured Plasmas (automatic linearisation process) allowing high reproducibility
of the processes.
2. The moment in which the system performs the optical zero during execution of a PHASE is determined
by one of the following events:
a. The enabled scales have measured a weight in field: OPT1_Weight.
b. The sensor selected in field: L_OPT2_OPT1 has switched on.
3. The two options for the zero of OPT1 (a. & b.) are mutual excluding and cannot both be enabled.
4. When the PHASE must extract air, it is necessary that the zero of OPT1 is activated on the air and
therefore immediately, so you must zero set the function OPT1_Weight

PHASE B: Transfer by weight of a single component
(even air if the optional side press is installed)
This phase manages the transfer by weight of a component from one satellite bag to another or even
the extraction of air if the secondary press is installed (optional). Transfer can occur by gravity or using
the optional press: the main press is not used. PHASE B: will end due to one of the following conditions, the
first one that occurs in chronological order:
1. The weight to be transferred set by the Operator has been reached (typical example PL in BC)
2. The normal maximum execution time of the PHASE has been reached (if function is enabled)
3. The scales have read the total transferred weight of the solution for the RBC (SAG-M).
4. The side press (optional) if set, has reached the final profile without any previous events.
5. The side press (optional) if set, has completely closed without any previous events.
When the PHASE ends, the machine automatically proceeds to the next phase in the program, otherwise if
-----------------------
<Transf.Phase: xx >
< >
< Wei.to transf. : - > - sets the weight of the component to transfer (0 – 600)
< Solut. Weight : - > - sets total solution weight (enter SAG-M value on the label)
< T max Phase : - > - max. phase execution time, after which alarm comes on (5-900)
< Phase End Time : - > - ends the PHASE upon reaching the value set (0-<T max)(0 disab.)
< En. Auto Reins : - > - automatically transfers 1, asks first to transfer = 0
-----------------------
NOTES:
- Wei. To transf.: set the weight you want to transfer from one bag to another in grams
- Solut.weigtht: generally used to check the successful total transfer of SAG-M: enter the value on the
SAG-M label (normally 100ml).
- T max Phase : Maximum execution time of the PHASE then alarm (5-900 sec)
- Phase End time: when the time has lapsed it forcedly ends the transfer even if the weight has not
been duly reached (function active if enabled).
- The first two Weight fields are mutual excluding (one cancel each other out).
-----------------------
<Transf.Phase: xx > Function enabled only if (optional) side press installed.
< -- Lateral Press -- >
< V1: - D1: - > - V1,D1: velocity and distance prof.1 (0-120RPM, 0-650 1/10th mm)
< Profiles End Pha: -> - The PHASE ends when the velocity profiles have ended (0-1)
< Close End Phase: -> - The PHASE ends when the press is completely closed (0-1).
-----------------------

PHASE C: Extraction of a component by differential weight (initial weight known)
PHASE C must always be used as the first PHASE of the PRG. This phase is useful for preparing the
second centrifugation of PLTS from PRP or CRYO from PL. The basic GIOTTO version is not supplied with
scales inside the main press (this is an optional) therefore, it is not possible to weigh the initial bag in the
press compartment. The basic version can nevertheless accurately determine the volume of a component
you want to leave in the bag as a residual, but this requires that you weigh the initial bag manually on one of
the other scales.
The procedure is as follows

1. weigh the centrifuged bag on one of the scales when requested by the PRG W_Tot.
2. the system measures the total weight and displays it on screen; subtract the set tare value and store
the data.
3. set a residual volume for the component you wish to leave inside the original bag (W_residual).
4. position the bag in the press if not already done and close the door.
5. the bag is pressed until the scales set for the extracted component measures the weight by
difference: W_diff. = [(W_Tot – W_Tare) – W_residual]
-----------------------
<Transf.Phase: xx >
< xxx >
< >
< T.max Phase : - > - sets the maximum PHASE execution time then the alarm comes on
< Bag Tare : - g> - tare in grams of the empty bag
< Residual Wei: - > - the weight you want to leave inside the main bag
< > (the one in the press)that determines the end of the PHASE
-----------------------
-----------------------
<Fase estr.: xx >
< xxx >
< >
< Res. wei. 3 : - > - 1st weight that determines the change of press velocity profile
< Res. wei. 2 : - > - 2nd weight that determines the change of press velocity profile
< Res. wei. 1 : - > - 3rd weight that determines the change of press velocity profile
< >
-----------------------
NOTES:
- if using the optional scales on the press, take great care when confirming the weight reading
with the ENTER key: read the weight with the door open, the bag must not touch the press
plate, nor must it sway and the tubes must not be stretched.
- To get the best weighing accuracy and to optimise the execution time, you may use more than one
velocity profile. The first profile must have a high velocity, in order to reduce the transfer time
whereas the last profile must have a very low velocity to improve the weighing accuracy. The end of a
velocity profile and transition to the next one, if present, is determined when the enabled weights
entered in the field shown above are reached.
- The residual weight must be < than residual weight 3, which must be < than residual weight 2, which
must be < than residual weight 1.
- The three fields are disabled if the transition of velocity profiles occurs by press position instead of by
weight.

-----------------------
<Fase estr.: xx >
< xxx >
< Main Press >
< V1: - D1: - > - main press velocity and distance with profile 1
-----------------------
If available, it is possible to use the side press instead of the main press.
-----------------------
<Fase estr.: xx >
< >
< Lateral Press >
< V1: - D1: - > - Lateral press velocity and distance with profile 1
-----------------------

PHASE D: Simultaneous extraction of two components
This PHASE is typically used when processing TOP & BOTTOM bags, in which the extraction of
erythrocytes and Plasma occurs simultaneously. The simultaneousness of the extraction considerably
speeds up the process, but maintains a high quality procedure.
PHASE D ends when the press reaches the position indicated by the last velocity profile.
-----------------------
<Transf.Pase: PL >
< RBC >
< LED BC Posit.: - > - sets the ref. press LED to hold still the BC (1 – 8)
< BC POS. Sens.: - > - sensitivity of selected press optical sensor (0 – 999)
< BC Emerg. LED: - > - sets the press emergency LED (above the BC position LED)
< Emer.LED Sens: - > - sensitivity of selected emergency LED sensor (0 – 999)
< >
-----------------------
-----------------------
<Fase estr.: PL >
< RBC >
< T.max Phase: - > - Maximum PHASE execution time (after which the alarm comes on)
< OPT1 weight: - > - weight on enabled scales to activate OPT1 zero (0-200)
< OPT1 Sens. : - > - sensitivity of main optical OPT1 (0 – 999)
< L_OPT2_OPT1: - > - Press LED that should switched on at main optical zero (0-8)
< OPT2 Sens. : - > - sensitivity of selected press optical (0 – 999)
-----------------------
NOTES:
1. GIOTTO is equipped with an automatic auto-zero system for the main optical sensor (OPT1). Each time
a PHASE begins that requires the use of the OPT1 sensor, the sensor’s optical zero is activated. This
serves to set at zero the optical differences among the various tubes available on the market or more
simply between different coloured Plasmas (automatic linearisation process) allowing high reproducibility
of the processes.
5. The moment in which the system performs the optical zero during execution of a PHASE is determined
by one of the following events:
a. The enabled scales has measured a weight in field: OPT1_Weight.
a. The sensor selected in field: L_OPT2_OPT1 has switched on.
2. The two options for the zero of OPT1 are mutual excluding and cannot both be enabled.
-----------------------
<Fase estr.: PL >
< RBC >
< >
< OPT1 End Phase : - > - ends the PHASE when OPT1 switches on (1 = YES, 0 = NO)
< OPT1 Speed Chang: - > - if OPT1 switches on, it changes to final Speed profile
< > enabled to allow the extraction of erythrocytes as planned
< > (1 = YES, 0 = NO)
-----------------------
-----------------------
<Fase estr.: PL >
< RBC >
< V1: - D1: - > - press Speed and distance with profile 1
-----------------------

IMPORTANT NOTE: The Right distance set in the final velocity profile determines the end of the
PHASE and the total volume of the bag (main bag in the press). To regulate the BC hematocrit and
therefore the PL / BC ratio inside the bag, you must set one of the eight press LEDs available with
control LED BC Posit.: where 1 = first LED at the top, 8 = last LED at the bottom. The sensor set in
LED BC Posit. is used by GIOTTO to block the BC in that position.
Graphic representation of the regulation of

the PL / BC ratio inside a bag.
1 1
2 2 1. the residual total volume is determined

3 3 by distance D* and that is the distance
4 4
set in the final velocity profile of the
PL PHASE.
5 5
2. the PL / BC ratio is instead determined
6 6 by the press LED (the black one) set by
7 7 function LED BC Posit. : You can see
8 BC 8 from the drawings the difference in
height of BC based on the selected
LED.
RBC The PL / BC ratio is crucial in order to
achieved the desired result when preparing
PLTS concentrates. It will vary if the PLTS
are produced from a single BC or BC pool.
See overleaf for further details.
= LED BC Posit. :
D*
D*
! IMPORTANT WARNINGS for TOP & BOTTOM bags !
1. to avoid errors due to the TOP breakable valve failing to open, which would mean the bag
could no longer be used (the RBC and a large part of the PL would all go in the SAG-M and
therefore it would not be possible to re-centrifuge), a PHASE A with transfer by fixed weight is
entered in the T&B Programs before starting the following PHASE D. By using this clever action,
the system is able to check whether the PL line is free and then pass automatically to PHASE D
without any problems. Vice-versa, if the valve remains closed due to an oversight by the Operator,
the system will detect this and signal an error caused by the set weight not being transferred.
2. PHASE D ends when the set distance is reached in the final velocity profile, but also when
sensor OPT1, if enabled, switches on: the first of these two events to occur will cause the
PHASE to end.
3. OPT1 is used when preparing dry BC, since the PL can be completely extracted until the main
sensor switches on.
4. If however, you are preparing wet BC for subsequent pools or other, sensor OPT1 should never
switch on. It is possible to enable this sensor for safety reasons.
5. To regulate the PL / BC ratio (BC hematocrit) in addition to setting the distance that regulates the
total volume you must also set sensor LED BC Posit. :.The BC is therefore held in the position
corresponding to the sensor that determines the final BC hematocrit.

PROGRAM 10 – TRIPLE BAGS:
PROCESSING WITH DRY BC OR FOR SUBSEQUENT BC POOLS (PLTS FROM BC POOL)
1. First - PHASE A: used for the reason described above. With PHASE A, 20 grams of PL are
extracted before moving on to the following PHASE D.
2. Second - PHASE D: simultaneous extraction of two components. The procedure ends when the
press reaches the preset distance.
3. Third - PHASE B (entered in Program 10 to transfer 3 grams): transfer of a single component by
weight. If necessary, it can be used to transfer a part of the previously extracted PL in the BC. This is
useful for washing the PL line or to transfer additional PL in the BC.
PROGRAM 11 – QUADRUPLE BAGS:

PROCESSING FOR SUBSEQUENT PLTS FROM SINGLE BC
1. First - PHASE A: used for the same reason described above, but with an additional aim. Since the
BC are not processed immediately, but agitated for several hours before the second centrifugation, it
occurs that part of the BC tends to rise in the tube making the valve dirty and therefore increasing the
contamination of the PLTS concentrate. To remedy this problem and at the same time to check that
the breakable valve opens correctly, before starting PHASE D you should use one PHASE A to
extract a small quantity of PL (20 grams) in the second satellite bag (not in the PL bag). At this point,
after the agitation process of BC, before inserting them again in the centrifuge, the PL inside the
satellite bag is made to flow in the BC, washing the entire line.
This process can considerably reduce the contamination of RBC in the PLTS.
2. Second - PHASE D: simultaneous extraction of two components. The procedure is the same as the
one describe above for the triple bags.
3. Third - PHASE B (entered in Program 11 to transfer 3 grams): transfer of a single component by
weight. If necessary, it can be used to transfer a part of the previously extracted PL in the BC. This is
useful for washing the PL line and to subsequently recover a higher number of PLTS from a single
BC.
FINAL NOTES ABOUT CREATING ANY PROGRAM
REMEMBER THAT:
1. The HEAD of a Program determines how and which hardware components are used from the
start to the end of that specific Program.
2. Every single movement of a component from one bag to another always requires execution of
an exclusive PHASE.
3. The extraction of air from a bag situated in the main press must be managed as an exclusive
PHASE A.
4. The extraction of air from a bag situated in the optional side press must be managed as an
exclusive PHASE B.
5. It is possible to move two components simultaneously only using TOP & BOTTOM bags and
only using PHASE D.

SECTION 7 How to load the bags
Once you have chosen the separation program, the machine will ask you to place the bags in position.
When this occurs, MAKE SURE that:
1. The bags and tubes are positioned correctly and properly inserted inside the clamps and optical
sensor.
2. The tubes have no blockages, excessive bending and are not stretched.
3. Once you have started the procedure NEVER TOUCH the tubes, bags or weights: you could
distort the weight readings or the optical system and jeopardise the extraction.
4. If you make any positioning errors or you want to pause the separation, press PAUSE, resolve the
problem, then press ENTER to restart the procedure or ESC to end it.
There are several ways in which to position the bags in the machine. This depends on the type of
procedure you intend carrying out and on the type of bag available, but always remember that the
bag in the press
MUST ALWAYS HAVE ITS LABEL FACING THE DOOR!
7.1 Tube positioning mask
In order to help the Operator correctly position the tubes, GIOTTO is equipped with a mask of luminous lights
for the clamps and main sensor. When a Program is selected, the corresponding clamp lights and the sensor
to use with that PRG will light-up RED. When the Operator correctly inserts the tubes the LED will light-up
GREEN.
7.2 Loading a set of STANDARD BAGS
This paragraph describes the correct way to load the bags on the system (example with standard quadruple
bags).
1. The bag containing centrifuged whole
blood must be inserted in the press
compartment with the label facing the
door.
2. If the needle on the tube of the bag is
facing upward, push it through the top
otherwise if it is facing downward through
the bottom.
3. The bag of plasma is normally hung on
the left on the vertical scales using clamp
no.1, while the bag of SAG-M is hung to
the right using clamp no.4.
4. The bag of BC is hung on the right side
scales using clamp no.2.
5. Thread the tube of the main bag inside
the optical sensor and the remaining part
in the relevant clamps.
Remember that:
- The example shows a standard
quadruple bag.
- Arrangement of the bags varies
according to the type of procedure and
bag available.

CAUTION !
When inserting the tubes, check that
they are positoned correctly inside
the clamps and the optical sensor !
The photo shows the correct
procedure to insert the tube in sensor
OPT1 and in clamp no.3: pull in
direction of the arrows as shown !
Close the press door and follow the instructions on screen.
Open the breakable valve(s) on the bag(s) ONLY when asked by the machine!
To break the valve on the main bag, hold the valve firmly and pull upwards gently whilst moving it to the right
and left to break the valve.
If you are using a SAG-M bag, remember to also break its valve.
Your GIOTTO machine is now ready for the first extraction with standard bags.
7.2 Loading a set of TOP & BOTTOM BAGS
The same recommendations for positioning standard bags and tubes are also valid for Top & Bottom bags.
1. The bag of whole blood must be

inserted in the press
compartment with the label facing
the door.
2. If the needle on the tube of the bag
is facing upward, push it through the
top otherwise if it is facing downward
through the bottom.
3. The bag of plasma is normally hung
on the left on the vertical scales
using clamp no.1, whereas if you are
using a second satellite bag this
should be placed on the right using
clamp no.4
4. The bag of SAG-M must be hung on
the right side scales with the tube in
lower clamp no.5.
5. Thread the main bag tube inside the
upper optical sensor and the
remaining tube(s) in the relevant
clamp.
Remember that:
- The example shows a triple bag.
- Arrangement of the bags can vary
according to the type of procedure
and bag available.

IMPORTANT NOTES
1. The use of the sensors is based on the type of procedure adopted and the settings for that
program. For example, if you are preparing PLTS from PRP, the sensors are irrelevant since
the quantity of PLTS concentrate is determined either by weight or by the press stopping in a
certain position.
2. THE BAG INSIDE THE PRESS MUST ALWAYS BE POSITIONED WITH ITS LABEL FACING
OUTWARDS!!

SECTION 8 Warnings, Alarms and Anomalies
8.1 INTRODUCTION
The GIOTTO software controls all the actions performed by the program in progress: when the machine
recognises an unforeseen condition it will generate a warning. These warnings are classified in three types:
WARNINGS, ERRORS and ANOMALIES.
WARNINGS are part of the normal interaction between operator and machine: procedure in progress, on-line
weight reading, and various signals.
ERRORS inform the operator about a problem that has occurred during the processing of a bag, for example
the impossibility to transfer, for some reason, the component from one bag to another or the accidental
escape of a tube from a clamp. Some errors suggest the operator should perform a corrective action, while
others cause a program interruption. In rare cases, you may require the help of the Technical Assistance
Service.
ANOMALIES inform the operator that a possible fault has been detected and that the machine is not able to
perform the operation planned. The help of the Technical Assistance Service is often necessary.

SECTION 9 MAINTENANCE
The operator is responsible for the maintenance of GIOTTO, which has been reduced to a few essential
clever actions: how to keep the front panel and press compartment clean and the six-monthly check of the
clamps and scales. A qualified technician authorised by the manufacturer should check the press system and
sensor calibration on a yearly basis.
9.1 Daily maintenance
9.1.2 Cleaning
Remove all the bags and clean the front panel and press compartment using a soft, clean cloth
dampened with detergent of disinfectant, taking care not to spill any liquid inside the machine or
scratch the transparent window of the optical sensors.
Before restarting the machine, thoroughly dry the parts using a dry cloth.
NEVER use abrasive products, acetone, trichloroethylene or other solvents.
9.1.3 Decontamination
NOTE: decontamination is an emergency procedure and must only be performed when necessary.
Generally, decontamination is only necessary after leakages following the breakage of a tube
or a bag.
In these cases:
- Switch off the machine and disconnect the supply cable.
- Carefully remove the bags wearing protective clothing (gloves, overalls, protective
glasses, etc)
- Using a disinfecting solution, clean all the machine’s exterior parts and the press
compartment, taking care not to spill liquid inside the electronic equipment. Using a
damp cloth, rinse the machine parts and dry them.
- If a tube breaks in a clamp:
• Remove the protective cover by pressing down on its axis and rotating it at the same
time in a counter clockwise direction: carefully extract it from the housing.
• Carefully clean the electrodes and all the surrounding area, taking care not to spill
any liquid inside the clamp: use damp pieces of gauze and if necessary cotton buds.
• Dry and check to make sure there is no dirt left in the clamp.
- Before switching on the machine again, wait at least 30 minutes so all the parts are
completely dry.
- Before using GIOTTO again, check the clamps following the procedure described in
Section 9.2.2.
Never use acetone, trichloroethylene or other solvents. Remember that the bleaching solution
tarnishes even steel, therefore use as little as possible and always dry using a cloth
dampened with clean or even better distilled water.
9.2 Six-monthly maintenance
The six-monthly maintenance is restricted to calibrating the weighing scales and checking the clamp-sealer
system and optical system.
9.2.1 Checking the weighing scales

To check the scales, you will need a calibrated weight of 500g (+/- 0.1g).
This check should be performed 30 minutes after switching on the machine, to allow the heat of
the electronics to stabilise.

From the main menu indicated here:

-----------------------
< GIOTTO R: xxx >
< date and time >
< 1- Programs >
< 2- Bilances >
< 3- Settings >
< 5- Tech Service >
< Select: >
-----------------------
select 5-Tech.Service + ENTER:

-----------------------
< Service Menu >
< >
< 1: CALIBRATIONS >
< 2: DIAGNOSTIC >
< 3: PROGRAMMING >
< Select: >
<ENTER to continue >
<ESC to Exit >
-----------------------
select 2: Diagnostic + ENTER and use the arrows to select the menu of the scales concerned
-----------------------
< Balances wiew >
< >
< g e bit >
< >
<.....................>
<UP/DOWN selection >
<ENTER to continue >
<ESC to Exit >
-----------------------
-----------------------
Press ENTER
----------------------- -----------------------
< Balance Manag. Menu > < Balance Manag. Menu >
< > < >
< B1= - g - bit> < B1= - ml - bit>
< B2= - g - bit> < B2= - ml - bit>
< B3= - g - bit> < B3= - ml - bit>
< B4= - g - bit> < B3= - ml - bit>
< B5= - g - bit> < B3= - ml - bit>
<ESC to Exit > <ESC to Exit >
----------------------- -----------------------
NOTE: weight can be displayed in ml or in grams according to the way in which the machine is set.
Therefore, place the sample weight on the scales and check that the machine reads the weight correctly.
Remember that, if you have a weight of 500gr this is equal to a value of 476ml (500g/1.051 = 476ml).
If the values read differ from the real ones by a value higher than ± 2%, please call the tech. service.
9.2.2 Checking the sealer clamps
Items necessary for this operation:

• One of your standard PVC bags with tubes full of water or physiological solution.
From the main menu indicated below:

-----------------------
< GIOTTO R: xxx >
< date and time >
< 1- Programs >
< 2- Bilances >
< 3- Settings >
< 5- Tech Service >
< Select: >
-----------------------
Select 5- Tech.Service + ENTER:
-----------------------
< Service Menu >
< >
< 1: CALIBRATIONS >
< 2: DIAGNOSTIC >
< 3: PROGRAMMING >
< Select: >
<ENTER to Continue >
<ESC to Exit >
-----------------------
select 2: Diagnostic + ENTER + use the arrows until you see:
-----------------------
< Verify Clamp >
< Close / Open >
< Sealing. >
< >
< >
<ESC to Exit >
-----------------------
press ENTER to continue:

-----------------------
<Select CLAMP: >
< >
<UP/DOWN Select.Clamp!>
< >
< >
<ENTER Open/Close >
<SEAL Start Sealing >
<ESC to Exit >
-----------------------
Use the arrows to select a clamp. Insert the tube and then use ENTER to open and close, SEAL to seal, ESC
to exit.
Should the tests not provide satisfactory results, you must contact the Technical Assistance Service.
9.2.3 Checking the main optical system OPT1
Items necessary for this operation:

• Black cardboard completely opaque to insert in the slot of the optical system OPT1.
From the main menu indicated below:
-----------------------
< GIOTTO R: xxx >
< date and time >
< 1- Programs >
< 2- Bilances >
< 3- Settings >
< 5- Tech Service >
< Select: >
-----------------------
select 5- Tech.Service + ENTER:

-----------------------
< Service Menu >
< >
< 1: CALIBRATIONS >
< 2: DIAGNOSTIC >
< 3: PROGRAMMING >
< Select: >
<ESC to Exit >
-----------------------
select 2: Diagnostico + ENTER and use the arrows to select the menu of the main optical system
-----------------------
< Display Main >
< OPTICAL ! >
< >
< >
< >
<ESC to Exit >
-----------------------
press ENTER to continue:
-----------------------
< OPTICAL 1 Value >
< >
< Value: bit >
< >
< >
<.....................>
< >
<ESC to Exit >
-----------------------
The optical value in free condition (No item inserted in the slot) should be 3000 ± 500 bit.
Now insert the black and opaque cardboard and the value should be 300 ± 200 bit.
Should the tests not provide satisfactory results, you must contact the Technical Assistance Service.

SECTION 10 TECHNICAL PARTICULARS
TECHNICAL PARTICULARS
Trade name:
Product code: GIO.DB.00
Manufacturer: DELCON s.r.l.

Via Matteucci, 25/27
20043 Arcore (MI) - Italy
Reference standard: EN60601-1 and EN EN60601-1-2
CE Classification: Class 1 Medical Device according to Directive 93/42

MDD and DL.vo n. 46/97.
Electrical supply: 115/230V AC ± 10% 50/60 Hz
Power consumption: 330 VA
Fuses: Two 1.60 AT - 230V

Two 3.20 AT - 115V
Supply cable: disconnectable type
Ambient operational conditions: Temperature: +10° ~ +35°C

Relative humidity: 30 ~ 85% without condensate
Storage conditions: Temperature: +10° ~ + 40° C

Relative humidity: 10 ~ 95% without condensate
Weighing scale accuracy: ± 2% at the bottom of the scale
Optical sensors: Class 1 equipment with LED, invisible

infrared radiation.
Maximum power emitted: <1 mW
Wave length λ : 880 nm
Reference standard: CEI EN 60825-1:2003
Average separation time of quadruple bag: 1.30 min in standard bag

2.30 min T&B bag
Alarms: acoustic and optical
Error and alarm codes: displayed on screen with description
Languages: Italian, English, Spanish (German and

French upon request)
In case of an electrical blackout: System reset (cancellation of single operation in

progress)
Measurements: mm. 400 H without scales vertical bar (+250mm. For

the bar)
mm. 330 D
mm. 400 L
Net weight: 35Kg for basic version without accessories
Size and weight with packaging: 560H x 520D x 500L mm – 50Kg.

SECTION 10 TECHNICAL PARTICULARS
Optional Equipment
- GIO.DB.10 DMS: data management software complete with network adapter
- GIO.DB.20 Additional scales for main bag (installed on the press)
- GIO.DB.30 Additional left scales with press
- GIO.DB.40 External scales with pan
- GIO.DB.50 External sealer handgun with 2m cable
- GIO.DB.60 CCD bar code reader
- GIO.DB.70 Network cable (connects one GIOTTO to another or to the DMS adapter)

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Automatic Blood Components Extractor

Instruction and Maintenance Manual

Man. Rev. 1.0

For assistance or additional purchases, contact us at the above.

Quality System in conformity with UNI EN ISO 9001:2000, UNI EN ISO13485:2004

COPYRIGHT & NOTES

Man. Rev. 1.0 Page 2 of 44

 Environmental risks and disposal

 Symbols and conventions

1 Introduction and use

6 How to change a Program

7 How to load the bags

8 Warnings, Alarms and Anomalies

Man. Rev. 1.0 Page 3 of 44

 WARNINGS FOR STAFF SAFETY

 ELECTROMAGNETIC EMMISION WARNINGS

Manufacturer’s guide and declaration – Electromagnetic emissions

Man. Rev. 1.0 Page 4 of 44

Guide to the electromagnetic

Man. Rev. 1.0 Page 5 of 44

In particular, the apparatus contains the following materials:

Man. Rev. 1.0 Page 6 of 44

2. Deliveries are chargeable to the customer.

For further information on the guarantee procedure, contact Delcon S.r.l.

Man. Rev. 1.0 Page 7 of 44

 Please read carefully

 Watch your hands, risk of crushing.

Before use the equipment, read carefully the instruction

PRP Platelet-Rich Plasma

PPP Platelet-Poor Plasma

RBC Red Blood Cell Concentrate or Erythrocyte

PdRBC Partially Leukoreduced Red Blood Cell Concentrate

PLTS or PC Platelet Concentrate

pdPC Partially Leukoreduced Platelet Concentrate

Cryo Cryoprecipitated (Factor VIII)

SAG-M Solution for Erythrocyte

T&B or TAB Top and Bottom bags

DMS Data Management Software (GIOTTO programming software to install

OPT1 Upper Main Optical Sensor

OPT2 One of the optical sensors on the main press.

Man. Rev. 1.0 Page 8 of 44

1.1 Purpose of use

1.2 A few concepts about the preparation of blood components

Man. Rev. 1.0 Page 9 of 44

PROCEDURE VALUE IN Gxs (integral force or AFC)

After the first centrifugation of WB:

PRODUCTS FROM PLASMA

PRODUCTS FROM BUFFY COAT

PRODUCTS FROM RBC

After the second centrifugation of the fractions:

PRODUCTS FROM PLASMA

PRODUCTS FROM BUFFY COAT

PRODUCTS FROM RBC

In addition, it is also possible to use GIOTTO to:

Man. Rev. 1.0 Page 10 of 44

2.1 Description of GIOTTO

GIOTTO – automatic blood component extractor

GIOTTO Standard Equipment:

Man. Rev. 1.0 Page 11 of 44

A FUNCTIONAL DESCRIPTION OF GIOTTO:

DATA MANAGEMENT AND ONBOARD SOFTWARE

! IMPORTANT NOTES about the data and how to manage it !

Man. Rev. 1.0 Page 13 of 44

Environmental risks and disposal

Symbols and conventions

WARNINGS FOR STAFF SAFETY

ELECTROMAGNETIC EMMISION WARNINGS

Please read carefully

Watch your hands, risk of crushing.