Milestone PRESTO Operator's Manual

PRESTO
Automatic Processor/Stainer for Frozen Sections
Operator Manual - MM115
PRESTO MM115-003 – 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 with the addition of this new instrument to your laboratory. We recommend carefully reading 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 +39.035.575498 web site www.milestonemedsrl.com e-mail marketing@milestonemedsrl.com
Carefully read this manual before using the instrument.
MM115-003 – PRESTO – Operator Manual 2018-05
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SUMMARY
SUMMARY ........................................................................................................................................................ 4
1. INTRODUCTION ........................................................................................................................................ 6
1.1. Symbols used .................................................................................................................................... 6
1.2. Intended uses .................................................................................................................................... 7
1.3. Technical specifications ..................................................................................................................... 7
1.3.1. Touch control terminal ............................................................................................................... 7
1.4. Transport and storage conditions ...................................................................................................... 8
1.5. Warnings ............................................................................................................................................ 9
1.6. Label ................................................................................................................................................ 10
1.7. Compatible reagents ........................................................................................................................ 10
1.8. Disposal ........................................................................................................................................... 11
2. INSTALLATION ........................................................................................................................................ 12
2.1. Space requirements ......................................................................................................................... 12
2.2. Unpacking and checking components ............................................................................................. 13
2.3. Fume extraction system ................................................................................................................... 16
2.4. Water fitting ...................................................................................................................................... 17
2.4.1. Water drain .............................................................................................................................. 18
2.5. Final placement ............................................................................................................................... 18
2.6. General description .......................................................................................................................... 19
2.6.1. Connect the Bar code reader ................................................................................................... 20
2.6.2. Remove or put the vessel support tray .................................................................................... 20
2.6.3. Remove or put the reagent cover disc ..................................................................................... 21
2.6.4. Remove or reposition the caps on the reagent vessels .......................................................... 23
2.6.5. Reagent positions inside PRESTO .......................................................................................... 24
2.7. Electrical installation ........................................................................................................................ 25
2.7.1. Power supply ........................................................................................................................... 25
2.7.2. Rear panel ............................................................................................................................... 26
2.8. Remote alarm connection ................................................................................................................ 26
2.9. Reagents.......................................................................................................................................... 26
2.10. Log in and Log out ........................................................................................................................... 27
2.10.1. Creating a new user ................................................................................................................. 28
2.11. Set date and time ............................................................................................................................. 30
2.12. Change the language ...................................................................................................................... 30
2.13. FineFIX tanks ................................................................................................................................... 31
2.13.1. Labels ...................................................................................................................................... 31
2.13.2. How to prepare the FineFIX working solution in tank .............................................................. 32
2.14. Charge the reagent FineFIX in the PRESTO .................................................................................. 33
2.14.1. Charge the consumables runs ................................................................................................. 33
2.14.2. Software activation sequence .................................................................................................. 33
2.14.3. Fill the FineFIX into the PRESTO ............................................................................................ 34
2.14.4. FineFIX heating settings .......................................................................................................... 36
2.15. Fill reagent vessels in the PRESTO ................................................................................................ 38
2.15.1. Labels ...................................................................................................................................... 38
2.15.2. Fill staining and cleaning reagents in the PRESTO................................................................. 38
2.16. Most used programs ........................................................................................................................ 41
2.17. Owner's settings .............................................................................................................................. 42
3. OPERATE WITH PRESTO ...................................................................................................................... 45
3.1. Loading slides in the rack ................................................................................................................ 45
3.2. Running a program .......................................................................................................................... 45
3.2.1. Run the most used program .................................................................................................... 46
3.2.2. Run a standard program .......................................................................................................... 48
3.3. Editing a program ............................................................................................................................ 51
3.3.1. Modify FineFIX loading temperature........................................................................................ 52
4. REAGENT MANAGEMENT ..................................................................................................................... 53
4.1. FineFIX use...................................................................................................................................... 53
4.1.1. FineFIX use as consumable .................................................................................................... 53
4.1.2. FineFIX use as reagent ........................................................................................................... 54
4.2. Vessel reagent reuse life ................................................................................................................. 55
4.3. Set staining and cleaning reagents ................................................................................................. 56
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4.4. Edit reagents list .............................................................................................................................. 57
5. SAFETY PROCEDURE ........................................................................................................................... 59
5.1. Water error ....................................................................................................................................... 59
5.2. Arm position error ............................................................................................................................ 61
5.3. FineFIX loading error ....................................................................................................................... 62
6. MAINTENANCE ....................................................................................................................................... 64
6.1. Introduction ...................................................................................................................................... 64
6.2. Before/after every process ............................................................................................................... 64
6.3. Daily ................................................................................................................................................. 65
6.4. Weekly ............................................................................................................................................. 65
6.5. Yearly ............................................................................................................................................... 65
7. DECONTAMINATION AND CLEANING .................................................................................................. 66
7.1. Safety precautions ........................................................................................................................... 66
7.2. Procedure for PRESTO decontamination and cleaning .................................................................. 66
7.2.1. Detergents ............................................................................................................................... 66
7.2.2. Procedure ................................................................................................................................ 67
8. PROCESS DOCUMENTATION ............................................................................................................... 70
8.1. Export saved process data .............................................................................................................. 70
8.1.1. How to remove a saved process ............................................................................................. 71
8.2. Install and operate with the LogViewer ............................................................................................ 72
8.3. Open process .................................................................................................................................. 72
8.4. Print process .................................................................................................................................... 73
8.5. Send process to customer support (Milestone) ............................................................................... 73
8.6. Export Events log ............................................................................................................................. 74
9. PRESTO OPTIONAL................................................................................................................................ 76
9.1. External exhaust fume filter kit (CODE 61550/F) ............................................................................ 76
9.2. FineFIX tanks ................................................................................................................................... 76
A.
Appendix – Tricks and advice .............................................................................................................. 77
A.1. Fatty tissues ..................................................................................................................................... 77
A.2. Suggestions for staining protocol modification ................................................................................ 77
To have better cleaned slide .................................................................................................................... 77
To modify staining .................................................................................................................................... 77
B.
Appendix – Alarm management .......................................................................................................... 78
B.1. Alarm management ......................................................................................................................... 78
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1. INTRODUCTION
1.1. Symbols used
The instructions marked by this symbol are important and require to be read carefully.
Instructions marked by this ATTENTION symbol indicate one should proceed with caution. Failure to comply with the instructions might cause damage to the user or the instrument.
Instructions marked by this symbol indicate one should proceed with caution due to the electrocution hazard. Ensure the instructions are followed carefully in order to avoid this type of incident.
Biological hazard: pay attention when performing a procedure marked with this symbol: 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.
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 to the environment.
Fragile
Manufacturer.
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1.2. Intended uses
Milestone PRESTO and its 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 samples for extemporaneous diagnoses in a quick, reliable and standardised manner.
The instrument has been conceived only for laboratory use (indoor use only). Milestone PRESTO must exclusively be used with the reagents listed in the chapter 1.7, “Compatible reagents”.
Any other use of the instrument should be deemed as misuse and forfeits the manufacturer's warranty.
1.3. Technical specifications
Power supply:
PRESTO Code 100000 230V~ 50/60Hz 500W PRESTO Code 100001 115V~ 60Hz 500W
Productivity: 90 slides per hour 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 Airflow interval: 35-45m3/h (cubic metres per hour), 20.6-26.5cfm Weight: 60Kg (132lbs)
Indoor use only.
1.3.1. Touch control terminal
The following picture shows the Touch Control TERMINAL of the PRESTO unit. It is possible to operate the unit simply by touching the icons on the screen.
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Two USB ports are fitted 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.
Features: Colour Display TFT-LCD 7” Resolution 800X480, Resistive Touch screen Mass storage 4Gb CPU 1GHz Windows™ Embedded Compact 7 Programs: Pre-set program, with user customisable programs. I/O-Interface 2 USB ports 2.0, 1 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 (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. Warnings
Any use of the instrument other than specified forfeits the warranty provided by the manufacturer.
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 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 authorised SERVICE personnel. If the system is not working correctly yet, you are kindly requested to contact the local authorised and qualified SERVICE representative or the manufacturer.
All parts of the instrument and parts must be exclusively be supplied by the manufacturer.
DO NOT OPEN THE UNIT'S CHASSIS. 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, parts, panels or cover. Only authorised and qualified personnel may repair and access the instrument's internal components.
It is essential to always follow the normal laboratory safety standards and good
practices. In using the instrument it is required to always follow the rules of common sense and best and most widespread laboratory practices.
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 comply with the instructions might lead to a decrease in the instrument's safety.
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1.6. Label
For an explanation of symbols see chapter 1.1.
1.7. Compatible reagents
Fixative
reagents
Staining reagents
Cleaning
reagents
Milestone
FineFIX
Hematoxylin Ethanol
Eosin Acetic Acid 2%
Xylene
Isoparaffin
(MileGREEN)
Isopropanol
DO NOT USE REAGENTS OTHER THAN THOSE LISTED ABOVE. In case of doubts contact: application@milestonemedsrl.com.
DO NOT USE HYDROCHLORIC ACID at any concentration.
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1.8. Disposal
This instrument is a medical in-vitro device and is usually installed in a laboratory where there 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 will no longer be accepted and you will be contacted to incur the relevant disinfection costs. International health standards require shipments of biological hazard material to be effected in standard containers (risk of sanctions).
Do not remove the instrument's structure panels during cleaning operations.
Disconnect the power supply before any operation. Do not use water directly on the instrument or at high pressure to clean the unit.
For reasons of safety any operation without personal protection equipment is to be avoided.
It is recommended to use polyphenolic disinfectants to clean and disinfect the instrument. For further information please contact the manufacturer: application@milestonemedsrl.com.
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 accident prevention and environmental protection requirements are in force in the country where the instrument is installed, this instruction manual must be supplemented with appropriate instructions to assure conformity with said requirements.
Disposal of reagents
Handle with the utmost care and store in a cool and dry area using a hermetic container.
Vapours might collect in empty containers, hence it is recommended to treat empty containers as hazardous waste. Waste materials must be disposed of in a certified incinerator or designated landfill, in compliance with provincial and local government laws. Certain reagents may have effects on health and cause environmental pollution.
For further information refer to the safety data sheets (MSDS) provided by the producer.
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2. INSTALLATION
Milestone PRESTO is an instrument that requires the utmost attention when unpacked and installed.
Arrange a bench at least 80cm (31.52in) wide and 100cm (39.4in) deep able to withstand the weight of PRESTO which is 60Kg (132.28lb). Then place PRESTO 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 directly under sunlight. Finally, ensure the tray 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 (7.88in) distance on each side.
2.1. Space requirements
PRESTO is shipped in a wood box with the following dimensions:
Width: 500mm (19.7”) Height: 950mm (37.43”) Depth: 1000mm (39.5”)
Unit dimensions:
Width: 400mm (15.76”) Height: 800mm (31.52”) Depth 920mm (36.25”)
Space dimensions required to place the unit:
Width: 800mm (31.52”) Height: 900mm (35.46”) Depth 1100mm (43.34”)
PRESTO is a heavy instrument. Check the bench for the maximum load. At least two people are necessary to move and unpack the instrument.
The MINUMUM bench depth required is 710mm (28in) BUT the unit will extend beyond the front of the bench.
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2.2. Unpacking and checking components
On opening the package ensure all parts are present by checking the list attached with the shipment. Attention must be paid during PRESTO unpacking to avoid scratches or damage to the chassis.
The PRESTO system (230V version, Code 100000 and 115V version, Code 100001) includes the following components:
Qty.1 Main power supply cable (Code 50036 for version 230V and Code 50391 for version 115V)
Qty.1 Fume extraction pipe (Code 61377) and Qty.2 Metal straps (Code 50051)
Qty. 1 Water filter of 20µm (Code 100180L) with two connectors G 1/2’’ (Code 68278)
Qty. 2 Water hose of 2m (Code 68309)
Qty. 2 Electropolished steel racks for 6 slides (Code 100177)
Qty. 10 Steel vessels for reagent (Code 100197)
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Qty. 1 Disc covering reagent vessels (Code 100068)
Qty. 2 2L Complete tanks (Code 65590)
Qty. 1 2L Tank (Code 65798)
Qty. 1 Kit Tank labels (Code 100016)
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Qty. 1 Kit Reagents labels (Code 100157)
White labels for reagents customization
Qty.1 Magnetic pen to work with the touch screen terminal (Code 50597/M)
Qty.1 Operator Manual in electronic format
Qty.1 USB key (Code 62160)
Qty.1 Bar code reader (Code 370059)
Qty. 1 Polypropylene funnel for reagents filling (Code 65628)
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2.3. Fume extraction system
PRESTO 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 installed properly, according to the local regulations in force on laboratory safety.
The customer is required to adapt the pipe connector. The plastic pipe supplied has the following features:
Length: 3m
Outer diameter: 69mm
Inner diameter: 60mm
Insert the extraction pipe (Code 61377) in the suitable outlet (rear panel).
Use the metal strap to fasten the pipe to the fume exhaust duct. (Code 50051).
Now connect the other end of the pipe to the laboratory's fume extractor.
The external fume extraction system must allow an air flow of 40m3/h (cubic metres per hour, 23.5cfm).
There is no air filter on the unit exhaust system.
It is possible to connect an external exhaust fumes filter kit (Code 61550/F), refer to paragraph 9.1.
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2.4. Water fitting
PRESTO unit, in order to work correctly, needs to be connected at the hydraulic system. The connections for the water loading (joint left IN) and unloading (joint right OUT), are present on the back side of the unit, they are showed in the following picture.
Connect the water pipe to the cold (max temperature = 35°C) water inlet (IN) located at the rear of the unit (minimum water pressure 2bar). Gradually open 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. 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.
Hydraulics Connection:
Input Water: tube connection 17mm (with connector G 1/2’’) Output Water: tube connection 17mm (with connector G 1/2’’)
The loading and unloading water pipes and other connectors are not provided with the unit.
The minimum difference height outlet permitted between the unloading of the unit and your hydraulic system is up to 50cm (19.7in), otherwise the system cannot download the water correctly.
Make sure that the output hose slope is about 10cm for every meter. Minimum input pressure 2bar. Milestone suggests to use 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. The concentration of these substances in the drain water is about 0.075% of FineFIX and Hematoxylin and 0.0015% of acetic acid.
The water discharged has to be connected following the local rules.
2.5. Final placement
The PRESTO unit may now be placed in its final use position. Ensure the unit is level.
Then connect: The main power supply cable to the power plug located at the rear of the unit then the power supply cable plug in the socket.
Now it is possible to switch PRESTO on.
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2.6. General description
1. Work area cover
2. Aspiration
3. Fresh FineFIX tank
4. Exhausted FineFIX tank
5. Reagent vessels
6. Touch control terminal
7. USB ports
8. Main switch
9. Tray for collecting excess reagents
1. Vessels cover disc
2. Reagent vessels
3. Water vessel
4. Arm with rack support
5. Slide rack
6. FineFIX vessel
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2.6.1. Connect the Bar code reader
Connect the USB of Barcode Reader to one of the USB ports on the PRESTO right side.
2.6.2. Remove or put the vessel support tray
The vessel support tray is needed for the correct positioning of the vessels. To put or remove the support tray (e.g. in case of cleaning) it is required to move the PRESTO arm in the high position, preferably in position 10UP in front of the operator (see section 2.6.5). Press the vessel reagent icon to automatically move the arm to the 10UP position (see chapter 2.15). Lift the tray and extract it from the arm.
Take out the support tray without the vessels on it.
To reposition the vessel support tray, insert the central hole in the arm, adjust the support so that the number 10 on the label is in front of you and the lateral holes fit with the fixed vessels (FineFIX and water vessels).
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2.6.3. Remove or put the reagent cover disc
Removal of the reagent cover disc is required for change of reagents operation and PRESTO cleaning and maintenance.
To remove the disc it is required to move the PRESTO arm in the high position, preferably in position 10UP in front of the operator (see section 2.6.5). For filling or changing the reagents or for PRESTO cleaning press the icon of the reagent management page: the software automatically moves the arm in the desired position (10UP, see chapter 2.15).
Before removing the reagents cover disc, unscrew the knob positioned behind the rack support and then lift the covering disc paying attention not to touch the reagent vessels and extract it from the arm.
Upon completing the operations that require disc removal, always reposition it.
Always replace the disc in position to avoid excessive evaporation of the reagents and preserve their cleanliness.
To reposition the cover disc, insert the central hole in the arm, adjust the disc so that the open part is underneath the rack support and the hole engages at the base of the arm. The hole in fact has a semi-circular shape with one straight side, which must be positioned behind the support position. The hole for the knob must match with the hole below: position the knob and screw it, holding the disc blocked.
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In case of using PRESTO in Safety Procedure (refer to chapter 5) do not move the arm, and extract the disc, passing its frontal slot through the arm piston (rotate the disc if it is necessary), as shown in the pictures below:
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2.6.4. Remove or reposition the caps on the reagent vessels
Each reagent vessel is equipped with a cap that prevents evaporation and oxidation of the reagents. The caps must be removed before any process and it is suggested to reposition them at the end of PRESTO use if it is not going to be used for a long time (more than 12 hours).
After opening the PRESTO cover and removing the vessels cover disc (see above), remove the cap while holding the vessel and with a slow and gentle motion to avoid moving the vessel and spilling the reagent. After removing the cap clean it from any reagent traces and set it aside (for instance, in the space between the two tanks).
Reposition the cap while holding the vessel and with a slow and gentle motion paying attention not to spill the reagent inside the vessel.
If desired, it is possible to put a number label on the cups, to use the same cup for each vessel. Use the Kit Reagents labels (Code 100157).
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2.6.5. Reagent positions inside PRESTO
The rack support may make two movements:
circular motion to move the rack in one of the 10 reagent positions.
vertical motion to lift the rack from one reagent and to lower it in another reagent. Moreover the vertical
movement allows the arm to do, in any position:
- dripping to move the rack up and down inside a reagent for mixing the reagent and for a better contact between sample and reagent.
- dipping to shake the rack for remove the excess of a reagent (this function is suggested after staining reagents).
There are 10 positions inside the PRESTO and they are numbered clockwise:
Position 10 The position immediately in front of the operator. It can be:
- 10UP, the position the PRESTO arm takes when it is required to remove or replace the reagents cover disc.
- 10DOWN, the position required when the tanks need to be removed or inserted. This is the idle position, when the arm goes after two minutes of inactivity.
Position 1 In this position the reagent vessel is fixed and it is designated for FineFIX which is filled and
drained automatically. Position 1DOWN, with arm lowered, is the loading position of the rack at the start of a process.
Position 3 This position is fixed and designated for the rinse water reagent, whose flow is regulated
automatically.
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Positions 2, 4, 5, 6, 7, 8, 9 These positions are designated for the staining and cleaning reagents. The
reagents set by default in these positions are those used in the default program HIGH QUALITY suggested by Milestone (refer to paragraph 3.2). The reagents in these positions are not fixed and may be set by the user, refer to paragraph 4.3 Set staining and cleaning reagents.
2.7. Electrical installation
2.7.1. Power supply
Power supply line needs to have a ground connection (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.
230V version: a schuko terminated power cord is provided. 115V version: a NEMA 5-15P terminated power cord is provided.
Before connecting the plug to the laboratory
socket, ensure the unit's power supply voltage
matches the laboratory's power supply line. Damage occurs if the instrument is supplied with incorrect power supply.
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2.7.2. Rear panel
The rear panel of the PRESTO has:
1. The power plug
2. The label with serial number
3. The water inlet/outlet connections
4. General fuses
5. External alarms connector
6. Ethernet/LAN connection
7. The connection to the fume extraction system (see below).
2.8. Remote alarm connection
Presto unit is provided with switch for external alarm devices.
For safety reasons and for preventing any damage to the internal relays, any external
devices that need to be connected to PRESTO unit must have a maximum Voltage lower than 40 VDC – 1A.
See also the instrument's label which provides some important information. Always provide the unit's S.N. to Customer Support.
2.9. Reagents
Complete the installation with the reagents, providing at least:
FIXATION/PROCESSING REAGENTS:
2L of diluted FineFIX
Reagent REQUIRED for operation: FineFIX Concentrate (5L tank: REF: 70148 or 10L tank: REF: 70149) is not included in the unit, to be ordered apart.
Output Contact Status
Identifies the PRESTO
alarm switch
1 Normally OPEN
2 COMMON
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