Milestone KOS User manual

KOS
Rapid Microwave Labstation
Operator Manual - MM073

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MM073-006 –Operator Manual
3
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 [phone]
web site www.milestonemedsrl.com
e-mail [e-mail]
Carefully read this manual before using the instrument.
MM078-006 –KOS –Operator Manual
2018-05

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MM073-006 –Operator Manual
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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. Microwave unit........................................................................................................................... 7
1.3.2. Touch control terminal ............................................................................................................... 8
1.3.3. GPR/K module........................................................................................................................... 8
1.4. Transport and storage conditions...................................................................................................... 8
1.5. Warning information........................................................................................................................... 9
1.6. Instrument labeling explanation......................................................................................................... 9
1.7. Compatible reagents........................................................................................................................ 10
1.8. Waste disposal of the equipment .................................................................................................... 11
1.9. Waste disposal of reagents ............................................................................................................. 11
2. SETTING UP THE INSTRUMENT........................................................................................................... 12
2.1. Introduction to KOS ......................................................................................................................... 12
2.2. Space requirements......................................................................................................................... 13
2.3. Unpacking and checking list............................................................................................................ 14
2.4. Final placement ............................................................................................................................... 15
2.4.1. Product overview ..................................................................................................................... 15
2.5. Fume extraction system................................................................................................................... 17
2.6. Power supply ................................................................................................................................... 18
2.7. Internet connection .......................................................................................................................... 19
2.7.1. How to start the Remote Assistance ....................................................................................... 21
2.8. Reagents.......................................................................................................................................... 22
2.9. Log IN and Log OUT........................................................................................................................ 23
2.10. Set date and time............................................................................................................................. 25
2.11. Set language.................................................................................................................................... 26
3. KOS HISTOMODULES AND OPTIONAL PARTS................................................................................... 27
3.1. Histoprocessing (up to 3mm thickness)........................................................................................... 27
3.2. Antigen retrieval............................................................................................................................... 32
3.3. Decalcification and/or fixation.......................................................................................................... 35
3.4. Special stains................................................................................................................................... 43
3.5. GHM/K Gross hardening ................................................................................................................. 44
3.6. Summary table................................................................................................................................. 45
4. OPERATE WITH KOS.............................................................................................................................. 47
4.1. Touch control................................................................................................................................... 47
4.2. Run programs.................................................................................................................................. 48
4.2.1. Histoprocessing ....................................................................................................................... 48
4.2.2. Decalcification.......................................................................................................................... 54
4.2.2.1 Decalcification with multiple module........................................................................................ 57
4.2.3. Special stains........................................................................................................................... 59
4.2.4. Antigen retrieval....................................................................................................................... 61
4.2.4.1 GPR/K Module......................................................................................................................... 64
4.2.5. Fixation .................................................................................................................................... 69
4.2.6. Gross hardening ...................................................................................................................... 70
4.3. Retrieving saved processing results................................................................................................ 71
4.3.1. How to delete a saved processing........................................................................................... 71
4.4. How to modify a program................................................................................................................. 72
4.5. Delete modified programs................................................................................................................ 75
4.6. Edit modified programs.................................................................................................................... 76
4.7. Create and modify favorite display .................................................................................................. 78
4.7.1. Delete from favorite list............................................................................................................ 79
4.8. Notes................................................................................................................................................ 80
4.9. Compliance...................................................................................................................................... 81
4.10. Help.................................................................................................................................................. 81
4.11. KOS system settings ....................................................................................................................... 82
4.11.1. Reagents management ........................................................................................................... 83
4.11.2. User management ................................................................................................................... 84

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4.11.3. Owner Settings ........................................................................................................................ 86
4.11.4. Remote Assistance.................................................................................................................. 87
5. REPORTING............................................................................................................................................ 88
5.1. Export processing from the terminal to the USB ............................................................................. 88
5.2. Install the LogViewer ....................................................................................................................... 89
5.2.1. Open process........................................................................................................................... 89
5.2.2. Print process............................................................................................................................ 91
6. MAINTENANCE ....................................................................................................................................... 92
6.1. Introduction...................................................................................................................................... 92
6.2. After each run .................................................................................................................................. 92
6.2.1. Rack cleaning procedure......................................................................................................... 93
6.3. Weekly............................................................................................................................................. 94
6.4. Monthly ............................................................................................................................................ 94
6.5. Every six month ............................................................................................................................... 94
6.6. Yearly............................................................................................................................................... 95
7. TECHNICAL TROUBLESHOOTING........................................................................................................ 96
8. GOOD PROCESSING PRACTICE.......................................................................................................... 97
8.1. Specimens....................................................................................................................................... 97
8.2. Fixation ............................................................................................................................................ 97
8.3. Beware............................................................................................................................................. 98
8.4. Reagents.......................................................................................................................................... 99
8.5. Microwave alcohols quality.............................................................................................................. 99
8.6. Tissue processing selection guidelines ......................................................................................... 100
8.7. Bone decalcification guidelines...................................................................................................... 102
A. APPENDIX......................................................................................................................................... 103
A.1. MW tissue processing troubleshooting guide................................................................................ 103
A.2. MW decalcification troubleshooting guide ..................................................................................... 110
A.3. Summary........................................................................................................................................ 111
B. APPENDIX......................................................................................................................................... 112
B.1. How to manage samples while an alarm is occurring during histoprocessing.............................. 112

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1. INTRODUCTION
1.1. Symbols used
An instruction accompanied by this symbol provides a cautionary statement: WARNING.
Failure to follow the instruction may endanger the USER 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.
Surface at danger temperature (more than 70°C, 158°F) do not touch.
Potentially flammable.
Laser source Class II.
Acid.
Aquatic pollution.
CE logo: this instrument complies with European community directives.
IVD medical device according to 98/79/EC directive.
Please read carefully this instruction.
Please read SERVICE Manual (operation for SERVICE only).
WEEE European directive symbol (2002/96/EC).
Electric/electronic device do not throw out in the environment.
Manufacturer.
Fragile.

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1.2. Intended uses
The Milestone KOS and its optional parts have been engineered 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 KOS Unit is specifically designed to semi automatically execute these processes for histopathological
applications:
Fixation, post-fixation
Dehydration and clearing
Paraffin WAX infiltration
Antigen retrieval
Special staining
Decalcification
The Milestone KOS must be operated exclusively with the reagents listed in “Compatible reagents” chapter
1.7.
Any other use of the instrument is considered improper and may void the warranty provided
by the manufacturer.
1.3. Technical specifications
Working Temperature: 15°C–30°C (59°F–86°F)
Humidity (relative): up to 80%
Maximum altitude: 2000m
This unit is developed to comply with the CAP-College of American Pathologists checklist for microwave
instruments requirements.
1.3.1. Microwave unit
Microwave Power: Max 800 Watt.
Power Emission: The Power Emission (Pulse Width) is controlled by the KOS software. The microwave
power output is regulated in 10 Watt increments. Control of microwave power is made
by modification of the In and Out phase of the Magnetron.
Power supply: 230 V ~ 50 Hz, 8A (see table below)
230 V ~ 60 Hz, 8A (see table below)
115 V ~ 60 Hz , 15A (see table below)
Safety Pack: Reagents and Organic solvent detector sensor, Humidity detection sensor, MW leakage sensor
Camera: Analogic camera 50Hz (PAL model) and 60Hz (NSTC model), front panel 5.6" color camera monitor
For more detail refer to chapter 2.6.

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1.3.2. Touch control terminal
It is possible to operate the unit by simply touching the icons on the screen.
Characteristics: TK-WIN10CEi-TFT-LCD color display
Resolution 800x600 pixels, 8’’
Touch screen
Mass storage CF 512MB
RAM 256 MB
CPU 500MHz
Windows™ CE.NET 6.0
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
The two USB PORTS are located adjacent to the main power switch, on the back side of KOS unit.
1.3.3. GPR/K module
Characteristic: Maximum solution volume: 750 ml
Slide capacity: 40 slides max.
Over pressure safety valve: to release pressure at 2 bar (130-135ºC).
Maximum working Temperature: 120ºC
1.4. Transport and storage conditions
Temperature: -20°C (-4°F) up to +60°C (140°F)
Humidity: up to 80% (up to 50% at 40°C –104°F) non-condensing
Before turning the KOS on (when coming from a storage room) please let the unit reach
working environmental conditions (at least half an hour).
The manufacturer reserves the right change and/or improve specifications without notice
and without incurring in obligation.
The manufacturer reserves the right change and/or improve specifications without notice
and without incurring in obligation.

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1.5. Warning information
Main power plugs are considered disconnecting device. Disconnect all plugs from the socket outlet before
assembling of the system and before cleaning.
Equipment shall be connected to main a 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 still not properly working, please contact the local authorized
and trained service representative of the manufacturer.
All parts of the equipment including optional parts shall be supplied only by the manufacturer.
Should the equipment be used in different ways than those specified by the manufacturer, the warranty
provided by the manufacturer may be void.
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.
Use caution when handling hot, molten WAX.
METAL PARTS
Never introduce metal parts into the MAIN CAVITY.
High voltage discharges may cause uncontrolled increases of temperature, which
could damage the unit and result in incorrect tissue processing also. 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.
Caution –laser radiation. Class II: if opening, do not fix the beam. When opening the
door, a laser beam appears to facilitate the correct positioning of the histomodule.
1.6. Instrument labeling explanation

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For symbols explanation see chapter 1.1.
Note only for Canada: this symbol indicates the compliance with the requirements of
CAN/CSA-C22.2 No. 61010-1, 2nd edition, including Amendment 1.
1.7. Compatible reagents
Fixatives
Dehydration
Clearing
Decalcification
Impregnation
Other
Milestone
FineFIX®
Milestone JFC
solution
Ethylenediaminetetraacetic acid
(EDTA) 20%
WAX, Histology
grade
Saline solution
Formalin,
buffered or
unbuffered
Milestone
Prowave®
solution
Formic acid 12%
Histochemical
stain for
histology
Formalin
saline
Ethanol
Milestone MoL-DEACALCIFIER
Sodium citrate
10mM, pH 6.0
Isopropanol
Tris/EDTA pH
9.0
Please refer to chapter 8.4 for purity grade of reagents.
DO NOT USE REAGENTS DIFFERENT FROM THOSE LISTED ABOVE.
In case of doubts please contact: [e-mail].
Reagents other than those listed above may damage some components of the instrument.
Do not use acetone, benzene or trichlorethane in the instrument!
Fixatives containing mercuric salts, acetic or picric acid will corrode metallic components
in the instrument and shorten instrument life.
If you choose to work with such fixatives, it is essential to perform a rack cleaning cycle
with multiple water rinses each time after use, to minimize damage.

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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 with the system.
It is required in case of return that the unit is cleaned and disinfected before sending it back to Milestone s.r.l.
Non-disinfected devices will be no longer accepted and you will be contacted to get 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 the use of polyphenolic based disinfectants 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 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 cold dry space using a tightly closed container.
Vapors 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 regulation.
Some reagents can have potential health effects and cause environmental pollution if not
correctly disposed.

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2. SETTING UP THE INSTRUMENT
2.1. Introduction to KOS
The KOS is a unit provided with state-of-art microwave Hardware/Software, that allows obtaining consistent
and reproducible results in the histopathology laboratory, for high throughput tissue processing and other
histological applications.
The system and its parts have been engineered for laboratory use and can therefore withstand the harshest
laboratory conditions for continuous use in Histological sample preparation procedures.
This manual refers to KOS, microwave Labstation and its application is suitable for NON vacuum processing
of tissue specimens with a maximum thickness of up to 3 mm.
The KOS concept
Microwave
Tissue
Processor
Specially
developed
Histomodules
A set of prestored
programs
Milestone KOS is a precision instrument that requires the utmost care when it is unpacked and installed.
The weight of KOS is approximately 40kg (88lb) at least 2 people should remove the
microwave unit from its box and locate it on the bench.

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Provide a vibration free bench of at least 0.55m in width and 0.8m in depth, suitable for a weight of 50kg and
place the KOS on it.
Make sure the unit is not placed against any side surface limiting the air cooling inlet/exhaust: let at least a
distance of 10cm for each side.
Never install the KOS unit under a fume hood.
The presence of acids or caustic reagents may contaminate the air flow used for ventilating
the electronic components, exposing them to possible corrosion or shorting of circuits.
CONNECTING CABLES
Never connect or remove cables when power to the unit is switched
on, to avoid risk of damage.
METAL PARTS
Never introduce metal parts into the microwave chamber.
High voltage discharges may cause uncontrolled increases
in temperature, which could damage the unit.
CLEANING CAVITY AND DOOR
Periodically inspect and clean cavity, door seals and
hinges. Do not use aggressive cleaning materials. If
microwave exposed surfaces are not kept clean, local “hot
Spots” are generated with possible corrosion of the metal
surface.
FOOD
Never heat food in a microwave oven used for laboratory procedures.
2.2. Space requirements
Unit dimensions:
UNIT
Width: 340mm (14in)
Height: 550mm (22in)
Depth: 530mm (21in)
CAVITY
Width: 240mm (10in)
Height: 265mm (11in)
Depth: 290mm (11.7in)
Space dimensions required to locate the unit:
Width: 970mm (38in)
Height: 920mm (36in)
Depth: 1090mm (43in)
NO

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2.3. 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 KOS, to avoid scratching or damage of the external coating. Check if your
KOS part number corresponds to the voltage supply of the laboratory, please refer to chapter 1.3.1.
KOS is delivered in a carton box (weight 50kg-110lb) with these dimensions:
Width
600mm (23.6in)
Height
900mm (35.4in)
Depth
800mm (31.5in)
A separate carton box (W480mm/19in-H100mm/4in-D480mm/19in) is positioned over the main carton box:
remove and keep it apart. This box contains optional parts which will be used during the installation of the
KOS.
Lift the main carton box up to facilitate KOS removal.
The KOS comes protected by a plastic bag to prevent problems of moisture infiltration during transportation.
Then open the box (or boxes) with parts (optional).
The KOS unit includes the following items:
1. Microwave unit complete with integrated Touch Control terminal
2. Power cord (x1)
3. Plastic hose + metal cable clamp
4. Operator Manual in electronic format
5. USB Data Traveler
Optional parts: Histomodules are supplied according to customer specific order (to be ordered apart).
POWER CORD
Code 67109 (115V ~ 60Hz)
Code 70304 (230V ~ 50/60 Hz)
PLASTIC HOSE and
METAL CABLE CLAMP
Code 50332
Code 64757

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2.4. Final placement
Now KOS unit can be positioned in its final place of use. When the instrument is positioned, it must be firmly
placed. Make sure that the bench is level.
Insert the positioning plate (Code 67210) in the KOS as shown below, with the mark TOP visible.
During the KOS SETUP the microwave unit should not be connected to the main power
supply.
2.4.1. Product overview
The picture below shows the front view of the KOS system.
Pull the handle towards the operator to open the door. On door opening, microwave emission is turned off by
4 safety mechanical switches.
An overview of the back side of KOS is shown in the following picture.
Main power
Switch &
USB ports
Door handle
Charcoal
filters
Terminal
& Cavity
monitor
Exhaust hose
connection
Power cord
connector
and fuses

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The KOS has dedicated software, based on Windows CE (Microsoft Windows CE is a trademark of Microsoft
Corporation). Use the touch screen pen to select the desired menu function.
The picture below shows the internal cavity of the KOS.
The KOS is neither a kitchen type nor a commercially modified kitchen type microwave unit. It is a rugged,
heavy duty professional system, designed to guarantee many years of trouble free and safe operation.
0
1
3
4
6
7
9
,
-
INFRA-RED SENSOR
Fully automatic non
contact temperature
control
100% walk-away
operation
EXHAUST FAN
No toxic vapors to
laboratory
Extraction of
vapors to fume
hood
R
E
A
R
F
R
O
N
T
AUTO START
MAGNETIC STIRRER
Homogeneous
temperature
distribution within the
solution eliminating
“Hot Spots”

All cassettes are
processed under the
same preset conditions
Touch screen
Terminal control
R
E
A
R
F
R
O
N
T

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2.5. Fume extraction system
The instrument is equipped with carbon filters (Code 67223) to avoid the releasing of fumes into the laboratory
environment. The carbon filter absorbs reagent fumes to prevent their diffusion into the laboratory atmosphere.
To ensure the filters are effectively operating, they must be periodically replaced (see chapter 6.5 for details).
The KOS is vented, according to CAP requirements, through the external exhaust outlet positioned on the
back of the instrument, with a hose dedicated to the external fume extraction system (if any).
In case of connection to an external fume extraction system, the customer is required to adapt the hose
connector. The plastic hose supplied has these characteristics:
Length: 2.5m(98in)
External diameter: 55mm(2.15in)
Internal diameter: 50mm(2in)
Connect the black exhaust hose of 2.5m (Code 50332) to the exhaust outlet located on the back panel of the
unit.
Use the metal cable clamp (Code 64757) to fix the hose to the exhaust outlet connection. Use a screw driver
to tighten the metal cable clamp.
Now connect the other side of tube the fume extractor of the laboratory.
Either the carbon filters or an external fume extraction system must be properly installed at
all times, according to local regulations in force on laboratory safety.
If the instrument is not connected to the laboratory fume extraction system, all fixation steps
must be carried out under the fumehood.
The external fume extraction system must permit an air flux of 36m3/h (cube meter per hour),
(21cfm).

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2.6. 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.
Plug/socket must be visible during the normal use and easily accessible.
Check if Voltage and Frequency on the back label of the KOS correspond to the power
supply outlet in your laboratory.
POWER SUPPLY
KOS
REF
115 V ~ 60 Hz, 15A
67050/W
230 V ~ 50 Hz, 8A
67051/W
230 V ~ 60 Hz, 8A
67052/W
Now you can connect the power supply cable and switch the KOS ON, using the main power switch located
on the back side panel of the microwave unit.
KOS is now ready for use.

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2.7. Internet connection
It is necessary to connect KOS to Internet to get Remote Assistance SERVICE.
IT IS NOT ADMITTED TO RUN PROGRAMS WITH KOS WHILE USING REMOTE
ASSISTANCE CONNECTION.
PROCESSES IN REMOTE ASSISTANCE ARE FOR TESTING USE ONLY,
NEVER PLACE SPECIMEN INSIDE KOS.
In order to access the remote assistance (as described in the chapter 4.11.4), following data are needed from
the Information Technology Department/Network ADMINISTRATOR of the laboratory:
- LAN connection with standard RJ45 Ethernet cable and connector
- Dedicated IP address and Subnet Mask (strongly preferred to DHCP SERVICE); only port 80 has to be
enabled without limitations
- LAN gateway and DNS server addresses
- At least 150kb/s real transfer rate (uploading and downloading).
When connecting KOS to remote assistance, it is necessary that Firewall, traffic data filters
and all software are disabled. Milestone s.r.l. strongly suggests not to use the DHCP
SERVICE, but fix the IP address in order to properly set up the LAN defenders.
From Log-in screen click on ADMINISTRATOR and insert the password (issued as a separate document
inserted in the Operator Manual).
The Administrator HOME PAGE appears. Press SETTINGS to access the administrator screen and then
press “OWNER SETTINGS”.

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The following screen appears. Enter the data required supplied by the Network Administrator.
For example:
A keyboard appears when clicking on any white box; insert the number required and then press directly the
green arrowed check box (in the figure below). Fill all white boxes with data network.
Press SAVE to store data, as shown below on the left and the message on the right appears.
Press Ok and restart the Unit, as indicated in the figure above.
IP Address
192.168.1.200
Subnet Mask
255.255.255.0
DNS server address
192.168.1.6
Default Gateway add.
192.168.1.1