Milestone DecalMATE User manual

DecalMATE
Automatic Fixation/Decalcication System
Operator Manual - MM112

DecalMATE
MM112-003 - Operator Manual
3
Thank you for having selected our system and welcome to the ever growing world club of users for Milestone
laboratory instrumentation.
We are sure that you will be completely satisfied with this new tool entering your laboratory.
We invite you to read carefully this operator manual and to keep it in reach for convenient and fast
consulting.
For any possible clarification or any request for assistance please contact either 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.milestonemedsrl.com
e-mail [e-mail]
Please read the user manual before using the device.
MM112-003 –DecalMATE –Operator Manual
2017-12

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SUMMARY
SUMMARY ........................................................................................................................................................ 4
1. INTRODUCTION........................................................................................................................................ 6
1.1. Symbol used...................................................................................................................................... 6
1.2. Designated uses................................................................................................................................ 7
1.3. Technical specifications..................................................................................................................... 7
1.3.1. Touch control terminal............................................................................................................... 8
1.4. Transportation and storage conditions .............................................................................................. 8
1.5. Warning information........................................................................................................................... 9
1.6. Labelling explanation....................................................................................................................... 10
1.7. Compatible reagents........................................................................................................................ 10
1.8. Waste disposal of the equipment .................................................................................................... 11
1.9. Waste disposal of reagents ............................................................................................................. 11
2. INSTALLATION........................................................................................................................................ 12
2.1. Space requirements......................................................................................................................... 13
2.2. Unpacking and checking list............................................................................................................ 14
2.3. Placement........................................................................................................................................ 16
2.3.1. Unit overview ........................................................................................................................... 16
2.4. Fume extraction system................................................................................................................... 17
2.5. Power supply ................................................................................................................................... 18
2.6. Electrical installation........................................................................................................................ 18
2.6.1. Back side connection plate...................................................................................................... 18
2.6.2. Main power supply connection ................................................................................................ 19
2.6.3. Power supply connection (NO UPS mode) ............................................................................. 19
2.6.4. Power supply connection (Local UPS mode).......................................................................... 20
2.7. Remote alarm connection................................................................................................................ 21
2.8. Reagents.......................................................................................................................................... 22
2.9. Log in and log out............................................................................................................................ 22
2.9.1. Create a new user ................................................................................................................... 23
2.10. Set system date and time................................................................................................................ 24
2.11. Tanks............................................................................................................................................... 25
2.11.1. Labels ...................................................................................................................................... 25
2.12. Load DecalMATE with reagents...................................................................................................... 26
2.12.1. Load DecalMATE with reagents.............................................................................................. 26
2.13. Most used programs........................................................................................................................ 29
2.14. Owner settings................................................................................................................................. 31
3. OPERATE WITH DecalMATE.................................................................................................................. 33
3.1. Loading cassettes into the rack....................................................................................................... 33
3.2. Run a program................................................................................................................................. 33
3.2.1. Run a favourite program.......................................................................................................... 34
3.2.2. Run a standard decalcification program.................................................................................. 38
3.2.3. Checking Status of DECAL Rate............................................................................................. 43
3.2.4. Interval check status................................................................................................................ 45
3.2.5. Run a program using the STEP START function.................................................................... 45
3.2.6. Run a DELAYED PROGRAM.................................................................................................. 45
3.3. Retrieving saved processes............................................................................................................. 46
3.3.1. How to delete a saved process................................................................................................ 48
3.4. Modify a program............................................................................................................................. 49
4. REAGENTS MANAGEMENT................................................................................................................... 51
4.1. Reagents reuse life.......................................................................................................................... 51
4.1.1. Reagents settings.................................................................................................................... 52
4.1.2. Recommendations for reuse life.............................................................................................. 53
4.2. Reagents replacement procedure ................................................................................................... 54
5. SAFETY MODE PROCEDURE................................................................................................................ 57
5.1. Power failure.................................................................................................................................... 57
5.2. Loading time out management........................................................................................................ 59
6. REPORTING ............................................................................................................................................ 60
6.1. Export processing from the terminal to the USB key....................................................................... 60
6.2. Install and operate with the LogViewer............................................................................................ 61

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6.2.1. Open process........................................................................................................................... 61
6.2.2. Print process............................................................................................................................ 62
6.2.3. Send process to customer support (Milestone)....................................................................... 63
6.2.4. Change settings....................................................................................................................... 63
6.2.5. Other functions......................................................................................................................... 64
6.3. ReagentLog and EventsLog from the terminal to the USB key....................................................... 64
7. MAINTENANCE ....................................................................................................................................... 66
7.1. Introduction...................................................................................................................................... 66
7.2. After each run .................................................................................................................................. 66
7.2.1. Rack cleaning procedure......................................................................................................... 67
7.3. Daily................................................................................................................................................. 67
7.4. Twice a week................................................................................................................................... 67
7.5. Weekly............................................................................................................................................. 67
7.6. Yearly............................................................................................................................................... 67
8. OPTIONAL ............................................................................................................................................... 68
A. Appendix.............................................................................................................................................. 69
A.1. BONE DECALCIFICATION THROUBLESHOOTING GUIDE......................................................... 69
A.2. BONE DECALCIFICATION GUIDELINE......................................................................................... 70
B. Appendix.............................................................................................................................................. 71
B.1. HOW TO MANAGE AN ALARM...................................................................................................... 71
C. Appendix.............................................................................................................................................. 73
C.1. HOW TO MANAGE SAMPLES WHILE AN ALARM IS OCCURRING............................................ 73

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1. INTRODUCTION
1.1. Symbol used
An instruction accompanied by this symbol provides a quite important and require
more attention.
An instruction accompanied by this symbol provides a cautionary statement: failure
to follow the instruction may endanger the operator or cause damage to the
instrument.
An instruction accompanied by this symbol provides a caution against electric shock.
Be sure to follow the instruction to prevent accidents resulting from electric shock.
Biohazard: be careful when you execute the procedure marked with this symbol:
danger of biohazard contamination.
Potentially flammable.
Corrosive.
Hazardous for the environment.
Please read SERVICE Manual (operation for SERVICE only).
CE logo: this instrument complies to European Community directives.
IVD medical device according to 98/79/EC directive.
WEEE European directive symbol (2002/96/EC):
Electric/electronic device do not throw out in the environment.
Fragile.
Manufacturer.

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1.2. Designated uses
The Milestone DecalMATE and its accessories have been developed for laboratory use and can therefore
withstand the harshest laboratory conditions for continuous use in Histological sample preparation
procedures.
The instrument is intended for laboratory use (indoor use) only.
The Milestone DecalMATE is specifically designed to execute these processes for histopathological
applications:
•Fixation
•Decalcification
The Milestone DecalMATE must be operated exclusively with the reagents listed in section Compatible
reagents chapter 1.7.
1.3. Technical specifications
CODE 101002: DecalMATE Power supply input: 230V~ 50/60Hz 700W
CODE 101004: DecalMATE Power supply input: 115V~ 60Hz 700W
Working Temperature: 15°C–30°C (59°F–86°F)
Humidity (relative): up to 80%
Maximum altitude: 2000m
Fan air flow range: 30-40m
3
/h (cube meter per hour)
Indoor use only.
Any other use of the instrument is considered improper and may void the warranty
provided by the manufacturer.

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1.3.1. Touch control terminal
The following picture shows the Touch Control terminal of the DecalMATE unit. It is possible to operate the
unit by simply touching the icons on the screen.
Two USB PORTS are located on the right side of the Touch Control Terminal.
Characteristics: TFT-LCD 7” widescreen colour display
Resolution 800X480,
Resistive Touchscreen
Mass storage 4GB
1CPU 1GHz
Windows™ Embedded Compact 7
Programs: Multiple pre-stored programs, with customizable user defined programs.
I/O-Interface: 2x USB port 2.0, 1x LAN Ethernet 10/100 Mbps RJ-45.
1.4. Transportation 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
The manufacturer reserves the right to change and/or improve specifications without
notice and without incurring any obligation.
Before turning DecalMATE on (when coming from a storage room), let the unit reach
working environmental conditions (at least half an hour).

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1.5. Warning information
Should the equipment be used in different ways than those specified by the manufacturer, the warranty
provided by the manufacturer may be void.
Main power plugs are considered disconnecting device. Disconnect all plugs from the socket outlet before
assembling of the system, before connection of the accessories and before cleaning.
Equipment shall be connected to a main power socket outlet which is accessible and visible by the operator.
Equipment is provided with replaceable fuses, however their replacement is to be performed by properly
authorized service personnel. If the system is not properly working, please contact the local authorized and
trained service representative of the manufacturer.
All parts of the equipment and all accessories must be supplied only by the manufacturer.
DO NOT OPEN THE CHASSIS! Failure to follow the instruction in the documentation
might lead to a reduction of device safety. If the equipment is not working properly,
please contact your supplier or the manufacturer.
Do not remove the instrument, accessories, panels or cover. Only authorized and
qualified SERVICE personnel may repair the instrument 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 practice when operating the
instrument. Failure to follow the instructions in the documentation might lead to a
reduction of device safety.
The Competent Authority owning the instrument has primary responsibility for
accident-free operation together with designated personnel who operates SERVICE
or repair it.
To avoid damage to the instrument, use only the reagents listed in section 1.7
Compatible reagents. Failure to follow the instructions in the documentation might
lead to a reduction of device safety.
Be careful: exhaust reagents are toxic and carcinogenic.
Handle with care and follow the local standard regulations.

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1.6. Labelling explanation
For symbols explanation see Chapter 1.1.
1.7. Compatible reagents
Fixatives
Decalcification
Other
Milestone FineFIX Ethylenediaminetetraacetic acid (EDTA) 20% Water
Formalin, buffered or
unbuffered Formic acid 20%
Hydrochloric acid 10%
Nitric acid 7%
Trichloroacetic acid 10%
Acetic acid 20%
DO NOT USE REAGENTS DIFFERENT FROM THOSE LISTED ABOVE.
In case of doubts please contact: [e-mail].

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1.8. Waste disposal of the equipment
This instrument is an in-vitro medical device and it is usually installed in a laboratory where specimens and
other biological tissues are present. For your safety, it is therefore required to clean and disinfect before
entering in contact with it. You must also wear gloves when operating the system.
In case of return it is required that the unit is cleaned and disinfected before sending it back to Milestone.
Non-disinfected devices will be no longer accepted and you will be contacted to pay the relative disinfection
cost.
International health rules require that shipments of biohazard materials are not done in standard packages
(risk of sanctions).
It is recommended to use enzymatic detergents and polyphenolic based disinfectants or chlorine substitutes
to clean and disinfect the instrument. In alternative, to decontaminate the instrument, the use of a solution of
1:10 Bleach (recommended by the CDC for disinfecting) is also allowed.
For further information, please contact the manufacturer: [e-mail].
In addition, complying with directive 2002/96/EC of the European Parliament and of the Council of 27
January 2003 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 2002/96/EC or of the local law which acknowledges it can have potential
effects on the environment and human health.
This symbol indicates separate collection
for electrical and electronic equipment
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.
1.9. Waste disposal of reagents
For further information please refer to the MSDS (Material Data Safety Sheet) provided by your supplier.
Do not remove the side panels of the unit during the cleaning operations.
Before doing any operation disconnect the power supply.
Do not use direct or high-pressure water to clean the instrument.
For safety reason, any operation without the individual protective devices must be
avoided.
Handle with care and store
in a cool dry space using a tightly closed container.
Vapours may collect in empty containers. Treat empty containers as hazardous.
Waste material should be disposed of in an approved incinerator or in a designated landfill
site, in compliance with all federal, provincial and local government regulations.
Some reagents can have potential health effects and cause environmental pollution if not
correctly disposed.

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2. INSTALLATION
Milestone DecalMATE is a precision instrument that requires the utmost care when it is unpacked and
installed.
DECALMATE Weight (read carefully):
The weight of DecalMATE is approximately 60kg (132lb) when empty; at least 2 peo
ple
should remove the unit from its box and locate it on the bench.
DecalMATE FULL weight: 70kg (154lb) (all reagents loaded in proper tanks).
Provide a bench of at least 82cm (32in) in width and 114cm (45in) in depth and that can stand a weight of
70kg (154lb), DecalMATE FULL weight (all reagents loaded in proper tanks).
Then place DecalMATE on the bench. Make sure that the unit is level and the bench is made of non-
flammable material and is vibration free.
Make sure the unit is not placed against any side surface limiting the air cooling inlet/exhaust: allow
at least a distance of 20cm (8in) for each side.
The following pictures show the dimensions of DecalMATE and the space required:
Height: 740mm (29in)
Width: 420mm (16.5in)
Width max: 510mm (20in)
Depth: 940mm (37in)

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2.1. Space requirements
DecalMATE is delivered in a wood box with these dimensions:
Width: 770mm (30in) Height: 1340mm (53in) Depth: 1020mm (40in)
Unit dimensions:
Width: 420mm (16.5in) Height: 740mm (29in) Depth: 820mm (32in)
940mm (37in) with fumes tube
Space dimensions required to locate the unit:
Width: 600mm (24in) Height: 840mm (33in) Depth: 870mm (34in)
990mm (39in) with fumes tube
DecalMATE is a heavy instrument. Check the bench for the maximum load.
The MINUMUM bench depth required is 710mm (28in) BUT the unit will came out frontally
from the bench.

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2.2. Unpacking and checking list
When unpacking, check that all parts correspond to the packing list included in the shipment. Utmost care
must be made during unpacking of DecalMATE, to avoid any scratch or damage of the external coating.
The DecalMATE unit (CODE 101002-230V or 101004-115V, with power supply cable) including the
following items:
CODE
DESCRIPTION
Qty
IMAGE
101022
Complete
processing tanks
4
101086
labels for the
tanks
1
101035
BLUE plastic work
area 1
62160
USB Data
Traveller
containing the
LogViewer
Software
1
61410
Exhaust Tube
complete 1

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67854
Rack 30
cassettes 1
65798F
Spare tank
(without tube) 2
65628
Polypropylene
Funnel for loading
of reagents
1
DecalMATE
Operation Manual
(MM112) with
Maintenance
Instructions
1

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2.3. Placement
DecalMATE unit can now be positioned in its final place of use. Make sure that the unit is level.
Check that the metal tray used to collect the eventual overflow of reagents is in the right position.
During the setup, the DecalMATE must be disconnected from the main power supply.
2.3.1. Unit overview
To open the CAVITY cover: flip up the cover.
To close the CAVITY cover: place white cover lid over the cavity, aligning the BLUE ARROW HEAD etching
on the cover with the external linear marker (Magnetic safety switch for unit to function).
A
location of the DecalMATE is near and connected to any
fume
extractor system using
the hose supplied. Make sure the unit is not placed against any back surface limiting the
air flow inlet/exhaust.
It is important that the arrow on the cover matches the pit on the tray otherwise the sensor
that checks the perfect closing of the cover doesn’t function.

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2.4. Fume extraction system
DecalMATE is vented, to comply with CAP regulations, through the external exhaust outlet positioned on the
back of the instrument, with a hose dedicated to the external fume extraction system.
The customer is required to adapt the hose connector. The plastic hose supplied has these characteristics:
•Length: 3m (110”)
•External diameter: 69mm (2.72”)
•Internal diameter: 60mm (2.36”)
Insert the exhaust tube on the proper outlet (back panel).
Use the metal cable clamp to fix the hose to the exhaust fume pipeline.
Now connect the other side of tube to the fume extractor of the laboratory.
The external fume extraction system allows the extraction from the front fans:
TANKS FAN CAVITY FAN
The DecalMATE must be connected to the external fume extraction system.
The external fume extraction system must be properly installed at all times, according to
local regulations in force on laboratory safety.
The external fume extraction system must permit an air flux of 40 m3/h (cube meter per
hour).

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2.5. Power supply
Power supply line must have a ground connection (yellow/green, green or bare wire).
Do not use the blue/white wire (neutral of power line). Power supply neutral has to be referred to ground.
Carefully check that:
•A strong ground connection is made available in the lab to assure the unit works correctly. Do not
connect a Milestone unit without ground connection.
•A dedicated ground connection direct from the main electric box (cabinet) of the laboratory to our unit
is ideal to eliminate any possible interference/electronic noise originated by other instruments
supplied with the same line.
•Power supply line wires (their size and distance from the switch board) used in the laboratory are
compliant with the label positioned on the back side of our units.
•Plug/socket is visible during the normal use and easily accessible.
Power line protection:
115V: Miniature circuit breaker curve C, 16A, interruption more than 6000A.
230V: Miniature circuit breaker curve C, 10A, interruption more than 6000A.
Residual current device: 30mA (Class I device).
230V version: a schuko power cord is provided.
The 115V a NEMA 5-15P power cord is provided.
Before connectin
g the plug to the laboratory’s socket CHECK that the power supply
voltage of the unit matches the power supply line of the laboratory.
Damages occur when wrong power supplies the instrument.
2.6. Electrical installation
2.6.1. Back side connection plate
Description:
1. Ethernet/LAN plug
2. Remote/external alarm connector
3. Main power supply connector input 230V – 115V
4. UPS side supply (controller power supply input)
5. UPS supplier socket (energy output to local UPS unit)
6. Speaker
4
3
5
2
1
6

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2.6.2. Main power supply connection
FOR 230V VERSION, connect the cable CODE 50036 (left figure below) to connector (main power supply).
FOR 115V VERSION, connect the cable CODE 50391 (right figure below) to connector (main power supply).
Finally connect the plug of main power supply to socket: now it is possible to turn the DecalMATE ON.
2.6.3. Power supply connection (NO UPS mode)
See also the Label of the instrument that provides some important information.
Always communicate the S.N. (Serial Number) of the unit to Customer Support.
As separable power cord, it is strictly required to use power cord with wire size at least of
1.5mm² (equal to minimum AWG12). A size less of 1.5mm² (AWG12) cannot guarantee a
proper functionality of the unit and overheating of the power cord.
Characteristic:
this is the easier way to supply DecalMATE, but it does NOT protect the unit from power
supply failure.
In fact, in case of power failure, user cannot remove samples from DecalMATE nor perform any
other operations.
For this reason, Milestone s.r.l. does NOT suggest this type of connection.
Make sure to inform the customer that in this way a power supply failure inhibits any operation with
DecalMATE.

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Connect the by-pass cable (CODE 66643) from (5) UPS supplier socket to (4) UPS side supply.
Finally connect the socket to main power supply connector input (3): now it is possible to turn DecalMATE
ON.
Do not connect UPS supplier socket (4) directly to the laboratory socket power supply:
this input power supply complies to CISPR 11 class A and may cause electromagnetic
interference to other devices.
2.6.4. Power supply connection (Local UPS mode)
Milestone can supply only UPS at 230V~ 50/60Hz (CODE 66100) with the following technical specifications:
230V version (CODE 66100)
•Voltage input 230V~ 50/60Hz according to your power supply
•Power 1000VA/600W (minimum)
•Capacity 15 minutes @ 500W (minimum)
•Output 230V~±10% 50/60±1Hz
•Transfer time 6ms (max)
•With cord set for connections
•Space 405×205x145mm
•Weight 10kg (22lb)
UPS unit at 115V~ 60Hz must be provided locally with the following minimum technical specifications:
Characteristic:
Milestone s.r.l. strongly recommends this type of connection as it protects DecalMATE
from power supply failure. In this case, in fact, DecalMATE cannot process, but can execute all others
procedures. In fact “UPS side supply” provides energy at logic circuits.
Even when DecalMATE is directly plugged into the main hospital UPS line or power emergency line, we
observed occurring of delays or discontinuity of a few seconds/minutes of the power supply. In this case
DecalMATE stops working and the standard power failure procedure, that puts tissues in safety, is not
activated. For this reason, we highly recommend to install a UPS module on any DecalMATE unit.
4
3
5
2
1
6