Milestone PRESTO PRO User manual

PRESTO PRO
Automatic processor/stainer
for next generation frozen sections
Operator Manual - MM136
MILESTONE
HELPING
PATIENTS

PRESTO PRO MM136-002 – Operator Manual
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Thank you for choosing one of our systems and welcome to the ever more crowded club of Milestone laboratory
instrumentation users.
We feel confident that you will be fully satisfied adding this new device to your laboratory.
We recommend to ready carefully this operator manual and to always keep it within reach for convenient and
quick referencing.
For any clarification or request for assistance, please contact our representative in your country:
Or contact:
Milestone s.r.l.
Via Fatebenefratelli, 1/5
24010 Sorisole (BG) Italy
Tel. +39.035.412 8264
Fax [phone]
web site www.milestonemed.com
e-mail [e-mail]
Read carefully this manual before using the instrument.
MM136-002 – PRESTO PRO – Operator Manual
2018-11

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CONTENTS
CONTENTS ....................................................................................................................................................... 4
1. INTRODUCTION ........................................................................................................................................ 6
1.1. Symbols used .................................................................................................................................... 6
1.2. Designated uses ................................................................................................................................ 7
1.3. Technical specifications..................................................................................................................... 7
1.3.1. Touch control terminal ............................................................................................................... 7
1.4. Transport and storage conditions ...................................................................................................... 8
1.5. Warning information........................................................................................................................... 9
1.6. Label ................................................................................................................................................ 10
1.7. Compatible reagents........................................................................................................................ 10
1.8. Waste disposal ................................................................................................................................ 11
2. INSTALLATION ........................................................................................................................................ 12
2.1. Space requirements......................................................................................................................... 12
2.2. Unpacking and check list................................................................................................................. 13
2.3. Fume extraction system................................................................................................................... 16
2.4. Water fitting...................................................................................................................................... 17
2.4.1. Water drain .............................................................................................................................. 18
2.5. Electrical installation ........................................................................................................................ 19
2.5.1. Power supply ........................................................................................................................... 19
2.6. Final placement ............................................................................................................................... 20
2.7. General description.......................................................................................................................... 20
2.7.1. Remove or place the reagent cover disc ................................................................................. 21
2.7.2. Add protection labels to the disc covering the reagents.......................................................... 22
2.7.3. Cover of the second loading position ...................................................................................... 22
2.7.4. Loading positions of the racks on the arm of the PRESTO PRO ............................................ 23
2.7.5. Remove or replace the caps to the reagent vessels ............................................................... 23
2.7.6. Remove or place the tray of reagent vessels .......................................................................... 24
2.7.7. Reagent positions inside PRESTO PRO................................................................................. 25
2.7.8. Connect the barcode reader .................................................................................................... 26
2.7.9. Rear panel ............................................................................................................................... 27
2.8. Remote alarm connection................................................................................................................ 28
2.9. Reagents.......................................................................................................................................... 28
2.10. Accessing and exiting the system ................................................................................................... 29
2.11. Create a new user ........................................................................................................................... 30
2.12. Changing the language.................................................................................................................... 32
2.13. Set Date and Time........................................................................................................................... 33
2.14. Fill the FineFIX reagent in the PRESTO PRO................................................................................. 33
2.14.1. Load the consumable changes................................................................................................ 33
2.14.2. Sequence of software activation.............................................................................................. 34
2.15. Load the reagents in the PRESTO PRO vessels ............................................................................ 35
2.15.1. Labels ...................................................................................................................................... 35
2.15.2. Load fixation, staining and cleaning reagents in the PRESTO PRO....................................... 36
2.15.3. FineFIX heating settings .......................................................................................................... 40
2.16. Most used programs ........................................................................................................................ 42
2.17. Owner Settings ................................................................................................................................ 44
3. USE PRESTO PRO.................................................................................................................................. 46
3.1. Loading slides in the rack ................................................................................................................ 46
3.2. Run a program ................................................................................................................................. 46
3.2.1. Run a favourite standard protocol............................................................................................ 48
3.2.2. Run a favourite “Continuous” protocol ..................................................................................... 51
3.2.3. Press the start button to run a standard protocol .................................................................... 57
3.2.4. Press the start button to run a “Continuous” protocol.............................................................. 59
3.3. Editing a program ............................................................................................................................ 60
3.3.1. Modify a standard protocol ...................................................................................................... 60
3.3.2. Modify a “Continuous” protocol................................................................................................ 62
3.3.3. Modify the temperature of the fixation reagent ........................................................................ 63
4. REAGENT MANAGEMENT ..................................................................................................................... 64
4.1. Use of FineFIX ................................................................................................................................. 64
4.2. Reuse of reagents ........................................................................................................................... 66

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4.3. Setting the configuration of reagents............................................................................................... 68
4.4. Edit reagents list .............................................................................................................................. 69
5. SAFETY PROCEDURE ........................................................................................................................... 70
5.1. Water error....................................................................................................................................... 70
5.2. Arm position lost error...................................................................................................................... 73
6. MAINTENANCE ....................................................................................................................................... 76
6.1. Introduction ...................................................................................................................................... 76
6.2. Before/after every process............................................................................................................... 76
6.3. Daily ................................................................................................................................................. 77
6.4. Weekly ............................................................................................................................................. 77
6.5. Yearly............................................................................................................................................... 77
7. DECONTAMINATION AND CLEANING .................................................................................................. 78
7.1. Safety precautions ........................................................................................................................... 78
7.2. Procedure for PRESTO PRO decontamination and cleaning ......................................................... 78
7.2.1. Detergents ............................................................................................................................... 78
7.2.2. Procedure ................................................................................................................................ 79
8. REPORTING ............................................................................................................................................ 81
8.1. Exporting saved process data ......................................................................................................... 81
8.1.1. How to delete a saved process................................................................................................ 82
8.2. Exporting the events log .................................................................................................................. 83
9. OPTIONALS ............................................................................................................................................. 84
9.1. External exhaust fume filter kit (Code 61550/F) .............................................................................. 84
9.2. FineFIX tanks................................................................................................................................... 84
A. Appendix – Hints and tips .................................................................................................................... 85
A.1. Fatty tissues..................................................................................................................................... 85
A.2. Tips to modify the staining protocol ................................................................................................. 85
B. Appendix – Alarm management .......................................................................................................... 86
B.1. Alarm management ......................................................................................................................... 86

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1. INTRODUCTION
1.1. Symbols used
The instructions marked with this symbol are important and must be read carefully.
An instruction accompanied by this WARNING symbol means you need to proceed with
caution. Failure to follow the instruction may endanger the user or cause damage to the
device.
When an instruction features this symbol, great care is required as there is the risk of
an electric shock. Carefully follow the instruction in order to avoid this kind of accident.
Biohazard: pay attention when performing a procedure marked with this symbol, as
there is a biological contamination hazard.
Pay attention: parts identified with this symbol are areas at risk of crushing hand and
or fingers.
Surfaces identified by this symbol feature a high temperature hazard.
Inflammable material.
CE Logo: this instrument complies with European Community directives.
IVD medical device according to directive 98/79/EC.
Symbol of the European WEEE directive (2002/96/EC):
electric/electronic material –do not disperse in the environment.
Fragile
Manufacturer.

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1.2. Designated uses
Milestone PRESTO PRO and its optional parts have been designed for laboratory use and are therefore able
to withstand the harshest lab conditions. They have been developed for continuous use in procedures for
fixation, processing and staining of specimens for extemporaneous diagnoses in a quick, reliable and
standardized manner.
Milestone PRESTO PRO must solely be used with the reagents listed in the “Compatible reagents” chapter,
refer to chapter 1.7.
Any other use of the instrument should be deemed as misuse and voids the manufacturer's
warranty.
1.3. Technical specifications
REF 100300: PRESTO PRO 230V~ 50/60Hz 180W
REF 100301: PRESTO PRO 115V~ 60Hz 180W
Productivity: 120 slides per hour
194 slides per hour with loading “Continuous”
Rack capacity: 6 slides
Number of stations: 10
Reagent vessel volume: 200ml
Operating Temperature: 18°C – 30°C (64.4°F – 86°F)
Humidity (relative): up to 80% non-condensing
Maximum altitude: 2000m (6561ft)
Air intake flow interval: 35-45m
3
/h (cubic meters per hour).
Weight: 42Kg (92lb)
The instrument is intended for laboratory use (indoor use) only.
1.3.1. Touch control terminal
The following picture shows the Touch Control Terminal of the PRESTO PRO unit. It is possible to operate the
unit simply by touching the icons on the screen.

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Two USB ports are at the sides of the Touch Terminal.
When the USB ports are not used, it is required to leave the port protection on, as shown
in the picture above.
Characteristics: TFT-LCD 7” widescreen color display
Resolution 800X480,
Resistive Touchscreen
Mass storage 4GB
CPU 1GHz
Windows™ Embedded Compact 7
Programs: Pre-stored and customizable user defined programs.
I/O-Interface: 2x USB ports 2.0, 1x LAN Ethernet 10/100 Mbps RJ-45.
The manufacturer reserves the right to change and/or improve the specifications with no
prior notice and without incurring any obligation.
1.4. Transport and storage conditions
Temperature: –20°C up to +60°C (-4°F up to 140°F)
Humidity: up to 80% (up to 50% at 40°C) (104°F) non-condensing.
Before switching on PRESTO PRO (when coming from a storage chamber), allow the
instrument to reach operating environment conditions (at least half an hour).

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1.5. Warning information
Any use of the instrument other than specified forfeits the warranty provided by the manufacturer.
PERSONAL DATA
The Device described herein is not intended for managing personal data of natural persons. Personal data of
natural persons shall not be inserted into the Device during the use of the Device. The organization that uses
the Device shall implement appropriate measures to ensure that no personal data of natural persons are
inserted into the Device. All the data referred to a person and inserted into the device shall use, at least, the
pseudonymization, in such a manner that the personal data can no longer be attributed to a specific data
subject without the use of additional information, provided that such additional information is kept separately
and is subject to technical and organizational measures to ensure that the personal data are not attributed to
an identified or identifiable natural person.
The main power supply plug is to be considered as disconnect device. Disconnect all plugs from the power
outlet before assembling the system, before connecting optional parts (if any) and before cleaning it.
The equipment must be connected to well visible sockets and accessible by the operator.
The instrument is supplied with replaceable fuses, but their replacement must be effected by trained and
authorized SERVICE personnel. If the system is still not properly working, please contact the local authorized
and trained SERVICE representative or the manufacturer.
All parts of the equipment and its optional parts shall be supplied only by the manufacturer.
DO NOT OPEN THE UNIT'S BODY. Failure to comply with the instructions in the
documentation might lead to a reduction in the device's safety. Should the equipment
not work correctly you are kindly requested to contact the supplier or manufacturer.
Do not remove the instrument, optional parts, panels or cover. Only authorized and
qualified personnel may repair and access the instrument's internal components.
It is important that normal standards for safety and good laboratory practices are
applied. Always use common sense and the best-known laboratory practice when
operating the instrument.
The Competent Authority who owns the instrument has the primary responsibility for
incidents due to operations on the instrument without attending personnel in charge
of use or repairs.
Only use the reagents listed in chapter 1.7 “Compatible reagents”, to avoid damage
to the instrument. Failure to follow the instructions might lead to decreased device
safety.

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1.6. Label
MILESTONE SRL
Via Fatebenefratelli, 1/5 – 24010 Sorisole (BG) – ITAL
Tel. [phone]
Fax. [phone]
PRESTO PRO
REF 100300
SERIAL NUMBER (SN)
INPUT
MANUFACTURED:
For an explanation of symbols see chapter 1.1.
1.7. Compatible reagents
Fixative
reagents
Staining
Reagents
Cleaning
Reagents
Milestone
FineFIX
Haematoxylin Ethanol >99.9%
(Ethanol)
Eosin
Acetic Acid 2% in
water
(Acetic Acid 2%)
Xylene
(Xylene)
Isoparaffin
(Isoparaffin,
MileGREEN)
Isopropanol
(Isopropanol)
Limonene
DO NOT USE REAGENTS OTHER THAN THOSE LISTED ABOVE.
In case of doubts please contact: [e-mail].
DO NOT USE HYDROCHLORIC ACID in any concentration.

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1.8. Waste disposal
This instrument is a medical in-vitro device and is usually installed in a laboratory where are specimens and
other biological tissue. For your safety, it is therefore required to clean and disinfect the instrument prior to
coming into contact with it. It is also required to wear gloves when operating the system.
In the event this instrument should be returned to Milestone S.r.l., it is required to clean and disinfect the unit
before shipping it. Non-disinfected devices shall not be accepted and you will be contacted to pay the relative
disinfection costs.
International health standards require shipments of biological hazard material to be effected in standard
containers (risk of sanctions).
Do not remove the frame panels of the unit during cleaning operations.
Disconnect the power supply before any operation.
Do not use direct or high-pressure water to clean the unit.
For safety reason, any operation without the personal protective equipment must be
avoided.
It is recommended to use polyphenolic based disinfectants to clean and disinfect the instrument.
For further information, please contact the manufacturer: [e-mail].
Complying with directive 2012/19/EC of the European Parliament and of the Council of 4 July 2012 on waste
electrical and electronic equipment (WEEE), the separate collection environmental managed of equipment is
mandatory.
It is necessary to return the used equipment to the distributor or to inquire about the presence of a local
empowered system for collection and disposal of WEEE.
The in-observance of Directive 2012/19/EC or of the local law which acknowledge it can have potential effects
on the environment and human health.
This symbol indicates separate collection
for electrical and electronic materials
If additional requirements on accident prevention and environmental protection exist in the country of
operation, this instruction manual must be supplemented by appropriate instructions to ensure compliance to
such requirements.
Waste disposal of the reagents
Handle with care and st
ore in a cool dry space using a tightly closed container.
Vapours may collect in empty containers. We therefore recommend treating empty
containers as hazardous waste.
Waste material should be disposed of in an approved incinerator or in a designated landfill
site, in compliance with all provincial and local government regulation.
Certain reagents may have effects on health and cause environmental pollution.
For further information please refer to the SDS (Safety Data Sheet) provided by your supplier.

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2. INSTALLATION
Milestone PRESTO PRO is an instrument that requires the utmost attention when unpacked and installed.
Arrange a bench at least 84cm (33in) wide and 70cm (27.5in) deep able to withstand the weight of PRESTO
PRO which is 42Kg (92.5 lbs).
Then place PRESTO PRO on the bench, ensuring the unit is level and the table is not flammable and vibration
proof. Ensure the instrument is positioned away from heat sources or from direct sunlight. Finally, ensure the
box collecting excess reagents is in the proper position.
Ensure the unit is not placed against any side surface thus restricting intake/outlet cooling
air: leave at least a 20cm (7.9in) distance on each side.
2.1. Space requirements
PRESTO PRO is shipped in a wooden case with the following dimensions:
Width: 580mm (23in) Height: 1000mm (39.4in) Depth: 1050mm (41.3in)
Unit dimensions:
Width: 440mm (17.3in) Height: 610mm (24in) Depth 525mm (20.7in)
Dimensions of the space required to place the unit
Width: 840mm (33in) Height: 900mm (35.4in) Depth: 725mm (28.5in)
PRESTO PRO is a heavy instrument. Ensure the bench can withstand it.
At least two people are necessary to move and unpack the instrument.
The MINIMUM depth required for the bench is 725mm (28.5in).
20cm
20cm
20cm
44cm
50cm
Width 440mm Depth 525mm
Height 610 mm
Maximum height 860 mm

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2.2. Unpacking and check list
On opening the package ensure all parts are present by checking the list attached with the shipment. The
utmost attention must be paid during PRESTO PRO unpacking to prevent scratches or damage to the body.
The PRESTO PRO system (REF 100300 and REF 100301) includes the following components:
•Qty.1 Main power supply cable (Code 50036 for 230V version)
•Q.ty. 1 Exhaust tube with 2 metal clamps (Code 61410)
•Qty. 1 20µm water filter (Code 100180L) with two G 1/2’’ connectors (Code 68278)
•Qty. 2 Water pipe 2m (Code 68309)
•Qty. 3 Electro-polished steel rack for 6 slides (Code 100177)

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•Qty. 10 Steel reagent container (Code 100197). Eight containers are labelled and designated for the
positions in the PRESTO PRO. The other two are for transporting the slides from the cryostat and the
stained ones to their place of assembly.
•Qty. 1 Aluminum vessel for heated reagents (Code 100344)
•Qty. 1 Reagent container cover disc (Code 100375)
Consisting of:
10 protective polyester discs (
Code
100323
)
Cover of the second position (
Code 100212
)
•Qty. 1 Safety screw of the reagent container cover disc (Code 100348)

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•Qty. 1 Tray for vessels (Code 100367)
•Qty. 1 Kit reagent labels (Code 100356)
White labels
for customization
of reagents
•Qty.1 Magnetic pen to work with the touch screen terminal (Code 50597/M)
•Qty.1 Operation manual in electronic form
•Q.ty 1 Linear barcode reader (Code 370059)

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2.3. Fume extraction system
PRESTO PRO is ventilated through the external exhaust outlet located at the rear of the instrument, with a
pipe connected to the fume extraction system (if any).
The external fume extraction system must be properly installed at all times, according to
local regulations in force on laboratory safety.
The customer is required to adapt the hose connector. The plastic hose supplied has these specifications:
•Length: 3m
•Outer diameter: 69mm
•Inner diameter: 60mm
Connect the exhaust tube (Code 61377) to the appropriate outlet on the back panel.
Use the metal strap to fasten the pipe to the fume exhaust duct. (Code 50051).
Now connect the other end of tube to the fume extractor of the laboratory.
The external fume extraction system must assure an air flow of 40m
3
/h
(cubic meter per hour).
There is no filter on the fume extraction system of the unit.
it is possible to connect an external exhaust fume extraction kit (Code 61550/F), please refer
to chapter 9.1.

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2.4. Water fitting
The PRESTO PRO unit is to be connected to the water system in order to work properly. On the back of the
unit are the ports for water inlet (left) and drain (right), pictured below.
Connect the (cold) water pipe to the water inlet at the rear of the unit. Gradually open the water "supply".
Connect the drain pipe to the water outlet at the rear of the unit.
It is mandatory to install the water filter between the tap and the
water inlet in the PRESTO
PRO. The filter prevents the formation of limestone and dirt in the water system of
PRESTO PRO.
The filter fittings are G 1/2’’.
In order to simplify the replacement of the filter cartridges, it is important to have a tap
upstream of the filter, as pictured below.
Milestone recommends working in cooperation with the hospital’s clinical engineering
department when installing the water system of PRESTO PRO.
Water connections:
Water inlet: connection for a 17mm pipe (with G 1/2’’ fitting)
Water outlet: connection for a 17mm pipe (with G 1/2’’ fitting)
The minimum difference in height between the water outlet and the water system is at
least 50cm (19.7in), otherwise the system does not drain water properly.
Ensure the drain pipe has a slope of approximately 10cm (4in) for every meter.
Incoming water pressure: maximum 2bar, minimum 1bar
Milestone recommends using a water softener.

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2.4.1. Water drain
The drain water is polluted with the reagents in which the rack is dipped before rinsing.
The amount of reagent that a fully loaded rack (6 slides) takes in is about 1 – 1.5ml. Therefore, the drain water
of a standard process, with water flow duration 30 seconds, contains about 1.5ml FineFIX, haematoxylin and
2% acetic acid. In other words, the concentration of these substances in the drain water is about 0.075%
FineFIX and haematoxylin and 0.0015% of acetic acid.
The waste water may contain pathogens and must be connected according to local
regulations.
In the interest of safety, the operator must be present throughout the entire process.

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2.5. Electrical installation
2.5.1. Power supply
The power supply line needs to be grounded. The earthing connection of the
power supply socket must be designated and come directly from the electrical distribution board of the
laboratory.
Carefully ascertain that:
•There is an earthed connection in the laboratory. Do not connect Milestone units without earthing
connection.
•The power cords (size and distance from the electric board) are compliant with the label on the back
of the unit.
•The socket is visible and accessible.
The power supply line needs to be grounded (Class I device).
Power line protection:
115V version: Miniature circuit breaker curve C, 15A, residual current device: 30mA.
230V version: Miniature circuit breaker curve C, 10A, residual current device: 30mA.
A power cord is supplied with Schuko plug.
Before connecting the plug to the laboratory’s socket, check that the power supply voltage
of the unit matches the power supply line of the laboratory.
Damage occurs if the instrument is supplied with incorrect power supply.

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2.6. Final placement
The PRESTO PRO unit may now be placed in its final position of use. Ensure the unit is level.
Then connect:
The main power supply cable to the power plug located at the rear of the unit, then plug the power supply
cable into the socket.
Now it is possible to switch PRESTO PRO on.
2.7. General description
1. Work area cover
2. Intake
3. Disc covering the reagents
4. Reagent vessels
5. Tray of the reagent vessels
6. Touch screen terminal
7. USB ports
8. Main power switch
9. Collecting tray (Code 100360) BEA
1. Arm with rack supports
2. Standard rack position (BLUE)
3. Secondary rack position (YELLOW)
4. Reagent containers
5. Water container
6. FineFIX Container
7. Tray of the reagent containers
3
1
2
4
5
6
7
8
9
1
2
3
4
5
6
7