Operator Manual: Rapid Microwave Labstation
Operator Manual: Rapid Microwave Labstation
Operator Manual: Rapid Microwave Labstation
H E L P I N G
P A T I E N T S
KOS
Rapid Microwave Labstation
Operator Manual
MM073-004 (June 2012)
Milestone s.r.l. MM073-004 – KOS – Operation Manual
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 +39.035.575498
web site www.milestonemedsrl.com
e-mail medical@milestonesrl.com
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
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 ....................................................................................................... 10
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 ACCESSORIES ........................................................................................ 27
3.1. Histoprocessing (up to 3mm thickness)........................................................................................... 27
3.2. Antigen retrieval ............................................................................................................................... 29
3.3. Decalcification and/or fixation .......................................................................................................... 32
3.4. Special stains ................................................................................................................................... 37
3.5. GHM/K Gross hardening ................................................................................................................. 38
3.6. Summary table ................................................................................................................................. 39
4. OPERATE WITH KOS.............................................................................................................................. 40
4.1. Touch control ................................................................................................................................... 40
4.2. Run programs .................................................................................................................................. 41
4.2.1. Histoprocessing ....................................................................................................................... 41
4.2.2. Decalcification .......................................................................................................................... 47
4.2.3. Special stains ........................................................................................................................... 50
4.2.4. Antigen retrieval ....................................................................................................................... 52
4.2.5. Fixation .................................................................................................................................... 60
4.2.6. Gross hardening ...................................................................................................................... 61
4.3. Retrieving saved processing results ................................................................................................ 62
4.3.1. How to delete a saved processing ........................................................................................... 62
4.4. How to modify a program................................................................................................................. 63
4.5. Delete modified programs................................................................................................................ 66
4.6. Edit modified programs .................................................................................................................... 67
4.7. Create and modify favorite display .................................................................................................. 69
4.7.1. Delete from favorite list ............................................................................................................ 70
4.8. Notes ................................................................................................................................................ 71
4.9. Compliance ...................................................................................................................................... 72
4.10. Help .................................................................................................................................................. 72
4.11. KOS system settings ....................................................................................................................... 73
4.11.1. Reagents management ........................................................................................................... 74
4.11.2. User management ................................................................................................................... 75
4.11.3. Owner Settings ........................................................................................................................ 77
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
1. INTRODUCTION
Biohazard.
Potentially flammable.
Acid.
Aquatic pollution.
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The Milestone KOS and its accessories 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.
This unit is developed to comply with the CAP-College of American Pathologists checklist for microwave
instruments requirements.
VALID ONLY FOR KOS COMPLETE KIT (NOT FOR KOS BASIC):
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The manufacturer reserves the right change and/or improve specifications without notice
and without incurring in obligation.
The two USB PORTS are located adjacent to the main power switch, on the back side of KOS unit.
The manufacturer reserves the right change and/or improve specifications without notice
and without incurring in obligation.
Before turning the KOS on (when coming from a storage room) please let the unit reach
working environmental conditions (at least half an hour).
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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 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 and all accessories shall 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.
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.
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.
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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.
Dehydration
Fixatives Decalcification Impregnation Other
Clearing
Milestone Milestone JFC Ethylenediaminetetraacetic acid WAX, Histology
Saline solution
Finefix® solution (EDTA) 20% grade
Formalin, Milestone Histochemical
buffered or Prowave® Formic acid 12% stain for
unbuffered solution histology
Formalin Sodium citrate
Ethanol Hcl 10%
saline 10 mM, pH 6.0
Tris/EDTA pH
Isopropanol
9.0
Methanol
Industrial
Methylated
Spirits
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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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).
Do not remove the side panels of the unit during the cleaning operations.
For safety reason, any operation without the individual protective devices must be
avoided.
It is recommended the use of 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: medical@milestonesrl.com.
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.
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.
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.
For further information please refer to the MSDS (Material Data Safety Sheet) provided by your supplier.
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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 accessories 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.
Microwave Specially
A set of prestored
Tissue developed
programs
Processor Histomodules
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
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.
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.
NO
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.
Unit dimensions:
UNIT Width: 340mm (14in) Height: 550mm (22in) Depth: 530mm (21in)
CAVITY Width: 240mm (10in) Height: 265mm (11in) Depth: 290mm (11.7in)
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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 (or KOS BASIC) part number corresponds to the voltage supply of the laboratory, please refer to
chapter 1.3.1.
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 accessories 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.
The KOS (or KOS BASIC) part number includes the following items:
1. Microwave unit complete with integrated Touch Control terminal
2. Power cord (x1)
3. Plastic hose + metal cable clamp
4. Operation Manual
5. USB Data Traveler
Accessories: Histomodules are supplied according to customer specific order (to be ordered apart).
Ref. P/N 67109 (115V ~ 60Hz) Ref. P/N 70304 (230V ~ 50/60 Hz)
POWER CORD
MM073
Ref. P/N 62160
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
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 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.
Door handle
Charcoal
filters
Power cord
connector
Exhaust hose and fuses
connection
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
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.
Touch screen
Terminal control
0
F R F
R E R
O A O
N R N
T 1
7
3
9
T
,
-
R
E
A
R
AUTO START
MAGNETIC STIRRER
• Homogeneous
temperature
distribution within the
solution eliminating
“Hot Spots”
• All cassettes are
processed under the
same preset conditions
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
The instrument is equipped with carbon filters (Ref. P/N 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).
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.
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)
3
The external fume extraction system must permit an air flux of 36m /h
(cube meter per hour), (21cfm).
Connect the black exhaust hose of 2.5m (Ref. P/N 50332) to the exhaust outlet located on the back panel of
the unit.
Use the metal cable clamp (Ref. P/N 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.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
Power supply line needs to have a ground connection (yellow/green, green or bare wire), do not use the
white wire (neutral of power line). Power supply neutral has to be referred to ground.
Power line protection: 115V: Miniature circuit breaker curve C, 15A, interruption more than 6000A.
230V: Miniature circuit breaker curve C, 16A, interruption more than 6000A.
Residual current device: 30mA (Class I device).
Check if Voltage and Frequency on the back label of the KOS correspond to the power
supply outlet in your laboratory.
POWER SUPPLY KOS BASIC RED KOS BASIC BLUE KOS BASIC GREEN
Ref. P/N Ref. P/N Ref. P/N
115 V ~ 60 Hz, 15A 67000/R 67000/B 67000/G
230 V ~ 50 Hz, 8A 67001/R 67001/B 67001/G
230 V ~ 60 Hz, 8A 67002/R 67002/B 67002/G
Milestone supplies the power cable, either for 115Vac or one for 230Vac, according to the
correct voltage of your country.
Both versions are provided with ground connection.
During the installation, our distributor will check the compatibility of our cable plugs with
the local electrical socket to guarantee the correct ground connection of the unit.
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.
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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:
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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Milestone s.r.l. MM073-004 – KOS – Operation Manual
The following screen appears. Enter the data required supplied by the Network Administrator.
For example:
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
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.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
The following screen appears and on selecting the REMOTE ASSISTANCE button, the icon turns in pink
and is automatically activated. See below.
Once activated, do not press the REMOTE ASSISTANCE icon again (to avoid multiple activations) until you
reboot the machine. Now remote service works with your instrument.
Do not disconnect nor restart the instrument during the remote connection.
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2.8. Reagents
PROCESSING REAGENTS:
DECALCIFICATION REAGENTS:
FIXATION REAGENT:
The above reagents must be onsite and available at time installation of unit.
The above reagents quantities are just a guideline, real quantities to be determined during
process, according to number of cassettes placed in the rack, samples type/size used.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
When the system is switched on, the LOG IN screen appears. Log in as Administrator is necessary to use
the main functions. Therefore press “Administrator” button, insert the password (issued as a separate
document inserted in the Operator Manual) and press the green arrowed check box (see below).
The Administrator HOME PAGE appears. As default, it shows the main programs.
From any screen, click on the Home icon circled in red (figure below) to go back to the home page.
SERVICE Log-in is available for authorized personnel only (ADMINISTRATOR can access
to a restricted SERVICE functions. SERVICE has complete access to the unit
functionalities).
Administrator and Service can customize the HOME PAGE under the Users management, choosing
between “Favorites” and “Main functions” (see below).
Go into the SETTINGS screen and select USER MANAGEMENT to create a new user.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
The User setting screen appears. Select CREATE A NEW USER; then press the NEW USER icon.
Enter the user name and password in the fields circled below (right).
In this page, select (all icons turn GREEN when activated):
Click on the icon circled in red, as shown below to return to the Main Programs screen
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
The SET CLOCK screen is accessed only by ADMINISTRATOR. Select SETTINGS icon from the MAIN
MENU, then SET CLOCK button.
Use the +/- buttons to set the right date and clock, after selection of these parameters touch SAVE to make
changes valid.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
Select SETTINGS icon from the MAIN MENU, then LANGUAGE SELECTION as indicated below.
After selection of the language, touch SAVE to make changes valid. See below figure left.
A message appears advising that the language will be changed at the first system reboot, as shown below.
Press Ok and restart the Unit.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
4 CASSETTES
4/K HISTOMODULES KIT for histoprocessing of up to 4 cassettes. Ref. P/N
Includes A-B-C 67390
Histomodule 4K for fixation, JFC, ethyl
alcohol and isopropanol (qty. 3)
Glass container 250ml
includes A1-A2-A3
Ref. P/N 60578
A1
Cover complete
Ref. P/N 67311
A
A3
Ref. P/N 67300
C
Ref. P/N 67301
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
45 CASSETTES
45/K HISTOMODULES KIT for histoprocessing of up to 45 cassettes. Ref. P/N
Includes A-B-C 67391
Histomodule 45K for fixation, JFC,
ethyl alcohol and isopropanol (qty. 1) Glass container 135mm
includes A1-A2-A3 Ref. P/N 67336L
A1
Cover complete
A Ref. P/N 67330
Ref. P/N 67320 A3
C
Ref. P/N 67325
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
16 SLIDES
Histomodule 16KS for up to 16 slides complete. Ref. P/N
Includes A-B-C 67350
A
Cross magnetic stirrer
B Ref. P/N 67344
C1
Safety carrier
Ref. P/N 67405
C2
C
Ref. P/N 67373 Stirrer with base mounted
Ref. P/N 67402
C3
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
40 SLIDES
Histomodule 40KS for up to 40 slides complete, with N 2 racks for 20 slides. Ref. P/N
Includes A-B-C-D-E 67355
Glass container 3L
Ref. P/N 67336
Cover complete
Ref. P/N 67330
Rack 20 slides
Ref. P/N 40156/2 (qty. 2).
D
Ref. P/N 67371/A
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
It is possible to order the rack Ref. P/N 40156/2 in quantity 4 to run up to 80 slides.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
Cooling tube
Ref. P/N 60103
A
Rack 20 slides
Ref. P/N 40156/2 (qty. 2).
Glass vessel
Ref. P/N 67425
Cover complete
Ref. P/N 67422
Stirring plate
Ref. P/N 67429
F
To be used with positioning plate GHM-KOS multifunctional Ref. P/N 67384 (supplied with the KIT GPR/K).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
4 CASSETTES
Decalcification and fixation of up to 4 cassettes.
Includes A-B
Histomodule 4K for fixation and
decalcification (qty. 1)
Glass container 250ml
includes A1-A2-A3
Ref. P/N 60578
A1
Cover complete
Ref. P/N 67311
A
A3
Ref. P/N 67300
Rack 4K complete (qty. 1)
B
Ref. P/N 67301
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
45 CASSETTES
Decalcification and fixation of up to 45 cassettes.
Includes A-B
Histomodule 45K for fixation and
decalcification (qty. 1) Glass container 135mm
includes A1-A2-A3 Ref. P/N 67336L
A1
Cover complete
A Ref. P/N 67330
Ref. P/N 67320 A3
Rack 45K complete (qty. 1)
includes B1
B
Ref. P/N 67325
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
60 MEGA CASSETTES
Starter Kit for mega cassettes for decalcification. Ref. P/N
Includes A-B 67410
Holder GHM-KOS
Histomodule 60 mega cassettes Ref. P/N 67385
includes A1-A2-A3
A1
A2
A
Ref. P/N 67409
Glass container 5 litres
Ref. P/N 67388
A3
B
Ref. P/N 60430
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate GHM-KOS multifunctional Ref. P/N 67384 (not included, to be ordered
apart).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
Positioning plate
Ref. P/N 67384
C2
C C3
Ref. P/N 67407
PTFE plate and new magnetic
stirrer complete
Ref. P/N 60380
C4
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate GHM-KOS multifunctional Ref. P/N 67384 (supplied with the KIT).
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
INTERNAL DIVIDER
Internal divider suitable for histomodule Ref. P/N 67320 for decalcification of large Ref. P/N
specimens. 67443
Internal divider complete (qty. 1)
includes A1
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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A
Cross magnetic stirrer
B Ref. P/N 67344
C1
Safety carrier
Ref. P/N 67405
C2
C
Ref. P/N 67373 Stirrer with base mounted
Ref. P/N 67402
C3
To be used with positioning plate Ref. P/N 67210 (supplied with unit).
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Holder GHM-KOS
Ref. P/N 67385
E
Gross Hardening Module GHM-KOS
complete includes C1
C
Ref. P/N 67375
When required, remove the built-in stirrer by rotating the screw clockwise.
To be used with positioning plate GHM-KOS multifunctional Ref. P/N 67384 (supplied with unit).
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It’s possible to run EM processing of samples by ordering the Starter Kit for EM
processing and polymerization for KOS Unit (Operation manual MM078).
To operate your KOS for EM processing, ask for authorization to Milestone s.r.l, mail:
medical@milestonesrl.com
customersupport@milestonemedsrl.com
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The KOS is controlled by an integrated touch control terminal, which is based on Windows CE operating
system.
The system has numerous pre-stored programs for tissue processing, high temperature procedures,
decalcification, fixation, gross hardening and special stains, with ability to store numerous customer defined
programs.
Power output is automatically controlled by a PID (Proportional Integrative Derivative) algorithm, which
allows the operator to set up the desired parameters (Time and Temperature) by simply drawing a curve. If a
pre-stored program is used, it is only required to adjust the time of the procedure in relation to the
specifications of the application.
The KOS allows the user to gain consistency and reproducibility of high quality results thanks to the working
procedures based on the concept of TIME at TEMPERATURE. The unit will always reproduce the same
conditions of temperature in the set times, by automatically adjusting the power level.
The KOS also allows the use of procedures based on the concept of TIME at POWER. The unit will always
reproduce the same conditions of power in the set times, by automatically adjusting the temperature level.
The following sections will show how to run, modify and create a program with the Touch Control terminal.
If additional information is required on the operation of the software for each of the sections below, contact
your local application support from your distributor.
On switching the power to KOS, the unit will run through a system check and enter the main login screen
user mode. The operator is required to log-in by touching the icon that relates to login (as an operator), either
as a USER, ADMINISTRATOR or SERVICE, then entering the password using the numeric keyboard.
On accepting the numeric entry login code, the MAIN MENU will appear consisting of touch screen icons that
are for specific applications, along with a number of ancillary functions.
For added security, the system enables different authorized users to logon by having a LOGOUT function
key at the bottom right of the screen and to prevent unauthorized use.
Milestone s.r.l recommends that these instructions are kept near the instrument to
facilitate operations and better understanding of the software functions, especially when
operating the unit for the first time.
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THICKNESS: 1mm
Now select the active green “GO” icon: a REMINDER screen appears (see the image below on the left).
The histomodule must match the positioning plate to be in proper position inside the cavity (left circle figure
below). For further confirmation, check that the laser beam centers the rack (right circle).
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4C: the correct level is approximately 1cm (0.39 15C: the correct level is labeled on the Histomodule
inch) above the cassettes (reagent about 200ml). (reagent about: 900ml 1 cassette-
850ml 15 cassettes)
30C: the correct level is labeled on the Histomodule 45C: the correct level is labeled on the Histomodule
(reagent about: 1400ml 16 cassettes- (reagent about: 1900ml 31 cassettes-
1350ml 30 cassettes) 1850ml 45 cassettes)
Load the RACK with cassettes and position the CASSETTE FIXING DISK on top. The fixing disk must
always be used, in order to avoid possible spilling out of cassettes from the rack during the processing.
Position the module to fit with the positioning plate, when the module is correctly positioned, the reagent
level is adequate and the magnetic stirrer is present, select OK in the REMINDER screen. See left figure
next page.
The screen on the right (next page) appears displaying a keypad: ENTER the number of cassettes to
process.
The Reagent Management System will be automatically updated and the number of cassettes selected will
be added to the cassettes already processed, so that also the status of the different reagents is kept
automatically updated up to their expiration time. For further information see also the chapter 4.11.1.
The yellow circle below displays the status of reagents. In this example, it is shown as READY, in other
cases it can be NEAR LIMIT or EXPIRED.
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After entering the number of cassettes to process, press the green arrowed check box. A display of the
processing phases appears.
ICONS explanation:
START: highlighted in green will start the selected phase. When highlighted in gray color, it is not
active.
SKIP: will advance the START icon to the next reagent phase: this allows manually start of a
program at any phase required, if wishing to bypass a reagent phase. Note that the SKIP
function will deactivate the previous phase by displaying COMPLETED, so do not use this
function unless certain that this is what is required.
<< >>: to scroll the screen and see all reagent phases.
-/+: to SUBTRACT/ADD time to a selected phase, either running or to be run.
EXIT: to cancel and exit an application. A message appears requiring confirmation to abort the
process or not. By choosing OK, user is required also to save any data up to the point of
exiting.
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FIXATION
Start the tissue processing by first loading the cassettes into the rack and begin from FIXATION.
Fixation must be preceded by a Pre-soaking step at room temperature in formalin.
If the samples have been already fixed out of the KOS, bypass the pre-soaking step selecting the SKIP icon.
Otherwise, if samples have not been fixed yet, include the pre-soaking step pressing the START icon.
On completion of the Pre-soaking step, the Fixation phase will automatically start.
During the microwaving phase in formalin, a RED line, representing the real time temperature curve, will
follow the BLUE preset temperature curve.
On completion of Fixation an audio alarm will sound (the operator can silence it on the screen).
ETHANOL
The screen now displays the GREEN START icon to the Ethanol phase. Transfer cassette rack to the
ethanol module.
Select START for the Ethanol phase. The GREEN START icon will advance to a REMINDER screen,
advising the operator to rinse the fixed samples in two changes of 100% ethanol, to remove formalin and
water residue carryover.
On completion of the RINSING step, select DONE. See below right figure.
The screen will advance the GREEN START icon to the Ethanol Phase. On completion of DEHYDRATION
and AUDIO ALARM sounds, cancel it.
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ISOPROPANOL
The screen now advances the GREEN START icon to the Isopropanol phase. Transfer cassette rack to the
Isopropanol module.
On completion of the Isopropanol phase an audio alarm sounds, cancel it. The GREEN START icon will
advance to the WAX phase.
WAX Impregnation
Now move the WAX module, currently sitting in your paraffin oven, to the KOS unit and transfer the cassette
rack into the WAX module.
For WAX phase, remember to insert the HEATING DISK in the glass container before
positioning the rack, as shown below, figure on the left. Failure to do this will damage the
samples. For further information, see the chapter 3.
When using rack 15K, 30K or 45K the paraffin level must be ready for use with up to 3
layers of cassettes (figure below on the right).
The level of WAX should reach the limit indicated on the glass (rack included, for any
number of cassettes processed) but not exceed it.
Put approximately 0.7 kg of paraffin to reach the proper level of paraffin.
When using rack 4K, the correct level of paraffin is approximately 1cm (0.39 inch) above
the cassettes.
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Now START the WAX program: on completion of the WAX phase, an audio alarm sounds and this screen
appears, asking to SAVE a report of the process. This report can be accessed later.
On completion of run and removal of rack, top up WAX level (the loss is due to tissue absorption and carry
over from rack).
The WAX module is removed and taken to the embedding center where the cassettes are embedded.
The processing procedure is now complete and another processing run can be started.
SCREENSAVER
Touch the graphical display of a running program to activate the SCREENSAVER, that displays the time
remaining of the currently running phase. To exit screensaver and go back into the graphical display, touch
the screen and the user name appears, enter the login PASSWORD in the white box by touching it.
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4.2.2. Decalcification
From the MAIN MENU screen select the DECALCIFICATION icon to be used. Note that BONE MARROW
PROCESSING includes tissue processing after the decalcification, whereas DECALCIFICATION for larger
bones will do ONLY the decalcification phase.
Select the BONE MARROW PROCESSING icon, the screen on the left appears.
The correct sequence is: first select the TEMPERATURE, second the HISTOMODULE, then the
DECALCIFICATION REAGENT to use.
Press GO to reveal the program or select the EDIT icon, to copy and customize the parameters needed.
Press GO and the system will automatically show the entire sequence. Several screen prompts advise the
action to take at each phase and step.
At the beginning this message appears (see below left figure). Check and confirm.
Then user is requested to enter the number of cassettes to be decalcified (right figure).
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If tissues have been previously fixed, it is possible to SKIP the fixation phase and proceed to the
DECALCIFICATION phase, by using the SKIP icon on the bottom of the screen.
Otherwise press the START icon to begin the fixation phase.
On completion of pre-soaking time in fixative, the system will AUTOMATICALLY START the microwave
FIXATION phase.
On completion of FIXATION an AUDIO ALARM sounds, cancel the alarm. A screen appears reminding to
perform a rinse in water before commencing the DECALCIFICATION phase (left figure below).
On completion of the rinsing time in water, an AUDIO ALARM sounds, cancel it. Now select the START icon
for DECALCIFICATION (right figure below).
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On completion of DEHYDRATION an AUDIO ALARM sounds, cancel it. Select the ISOPROPANOL clearing
phase and press START (figure below left).
On completion of clearing in ISOPROPANOL an AUDIO ALARM sounds, cancel it.
Get the WAX module out from the paraffin oven. Please refer to the WAX phase described in the chapter
4.2.1 for proper use of WAX Histomodule. Then START the WAX phase (figure below right).
On completion of the last phase (WAX phase), the AUDIO ALARM sounds and a screen appears asking
whether to SAVE a report for this process or not.
This report is essential for documenting the entire procedure just completed, which can be retrieved for
review and printing at a later date.
Now transfer the cassettes to the embedding center and return the WAX module to the paraffin oven.
On completion of embedding, clean the cassette rack, so it is ready for the next run (see the Rack cleaning
procedure chapter 6.2.1).
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Select a stain, in the example below ELASTIC ORCEIN (figure left). A reminder screen appears (figure right).
Select OK to go into the working program screen, showing the FULL STEP BY STEP PROCEDURE, from
dewaxing to mounting of slides.
This detailed procedure is ideally suited for junior techs under training in the procedure.
For the experienced user the procedure can be customized to show only the MAIN steps.
For more details see the chapter 4.4.
Please remember that:
• all non-microwave steps are performed outside the KOS unit
• all microwave steps are performed inside the KOS unit.
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In the screen below, move through each step by pressing DONE when completed, resulting in a green
arrowed check box. By pressing the SKIP icon, the step is bypassed resulting in a red crossed check box.
In both cases, the program will advance to the next step.
Go through all steps until the procedure is completed; a screen will appear asking to SAVE a report of this
process, essential for documenting the entire staining procedure performed.
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Use of rack for 20 slides inside histomodule 40KS or GPR/K requires a slight modification
of the handle of these racks in order to have them perfectly fit inside the glass container.
These racks are supplied entire, with the long handle.
Pictures below indicate the height user had to cut the handle of the racks:
Histomodule 40KS
Entire
13.5cm
11cm
(5.32in)
(4.33in) 7.5cm
(2.96in)
1° 2° 3° 4°
1. First rack is put on the bottom of the glass, no need of cutting the handle.
2. Second rack requires cutting at 13.5cm (5.32in) from the bottom.
3. Third rack requires cutting at 11cm (4.33in) from the bottom.
4. Fourth rack requires cutting at 7.5cm (2.96in) from the bottom.
Histomodule GPR/K
7.5cm 5cm
(2.96in) (1.97in)
1° 2°
From the MAIN MENU screen, select ANTIGEN RETRIEVAL, the screen on the right appears.
The duration (5min or 15min) refers to the Time at Temperature (93°C, 95°C, 98°C, 100°C,
110°C, 120°C).
When using more than 40 slides but less than 80 slides, select the program relating to the
Histomodule 80S.
The default protocols for Antigen Retrieval are reported in the table below.
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Press GO to reveal the program or select the EDIT icon, to copy and customize the parameters needed.
Press GO and the system will automatically show the confirmation screen (see above right figure).
On selecting OK on the REMINDER screen, the working program screen opens.
The correct level of reagents corresponds approximately to 1 cm (0.39 inch) above the slides.
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GPR/K MODULE
Under Pressure High Temperature Antigen Retrieval up to 120°C.
DO NOT run programs with a maximum temperature set higher than 120°C.
Never open the locking nuts of the pressure reactor unless it has been
cooled down: without proper cooling a sudden pressure release of hot vapors will occur.
DO NOT open the pressure release valve of the unit unless it has been cooled
down: risk of hot vapors leakage that can affect operators safety.
When operating with the GPR/K, wear suitable laboratory grade coat,
gloves, safety eye glasses.
OPERATING PROCEDURE
1. Remove cover of GPR/K by first removing the pressure locking nuts by hand.
Proceed as follows: slightly unscrew ALL the nuts, make sure NOT to totally unscrew or remove any of them;
when all nuts are partially unscrewed, proceed with taking them away one by one.
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3. Insert slide rack with appropriately cut handle, add sufficient ER solution to cover the slides
(approximately 550 ml for 20 slides and 750 ml for 40 slides).
4. Reposition the cover on the glass vessel and the pressure locking nuts into position and secure by
hand. Proceed as follows: slightly screw ALL the nuts, make sure NOT to totally screw any of them;
make sure that all nuts are totally screwed.
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5. Insert positioning plate (Ref. P/N 67384) in the cavity. It should rest firmly against the back wall of the
cavity.
6. Lift the GPR/K using the safety handles and insert it into the cavity, firmly against the positioning
plate to fit perfectly; the right position is shown in the picture below.
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For example:
Run the program by pressing the GO icon and the system automatically shows the confirmation screen (see
above right figure).
Select OK to go to the working program screen.
On completion of Antigen program, the system warns the operator to SAVE a report of the Antigen program
just completed.
8. Open the door, take the GPR/K out and slide in the cooling tube, turn on the water flow.
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9. After cooling carefully lift the over pressure safety valve up. This assures the pressure is back to
normal. Then it is possible to open the locking nuts.
10. Utmost attention must be paid when opening the GPR/K. If glass container does not separate from
the cover (because of the vacuum generated during the cooling phase), do not force it but lift the
over pressure safety valve up to let air in.
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4.2.5. Fixation
From the MAIN MENU screen, select FIXATION icon shown below.
The following screen appears: choose the fixation temperature and the histomodule to be used.
Press GO to reveal the program or select the EDIT icon to copy and customize the parameters needed.
On selecting GO the reminder screen appears (figure below left), press OK and the working program screen
is displayed (figure below right).
Pressing START, the system screen reminds a PRE-SOAKING penetration step, if required.
On completion of the pre-soaking time, the program will AUTOMATICALLY START the microwave fixation
phase.
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On completion of FIXATION, the system will display the screen requesting the operator to SAVE a report of
the fixation program just completed.
The following screen appears: select the process temperature, the histomodule and the duration.
Press GO to reveal the program or select the EDIT icon to copy and customize the parameters needed.
On selecting GO the reminder screen appears (figure below left), press OK and the working program screen
is displayed (figure below right).
On completion of GROSS HARDENING, the system will display a screen requesting the operator to SAVE a
report of the program just completed.
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Select a date and the relative list of results is displayed on the right. To view a specific file, select it and
press View Log: the process executed is shown.
More detailed viewing information, as well as printing features, can be accessed using the
Export function displayed below.
The exported files can then be viewed using our LOG VIEWER Software (supplied apart).
For further information see chapter 5.2.
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Modified applications are not listed under the corresponding icons of origin, but in a
separate list under User Programs icon. For this reason it is severely recommended that
any modified program is named appropriately.
To create a program irrespective of the application, select an existing program from the main menu below.
On selecting the application, for example Histoprocessing Transplant, choose the processing protocol to be
used as template. This procedure is similar to tissue processing procedure, but YELLOW “EDIT” icon must
be selected instead of GREEN “GO” icon. See below.
Click on EDIT icon, the following edit screen appears. To change the program name, enter the new one with
the keyboard and press the green arrowed check box. Otherwise press directly the check box, if the name
displayed is correct, as shown in the figure below.
Do not use keyboard symbols to create a new program name (for example *, /, #).
Use numbers, letters and only the symbol “-“.
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Then the following edit screen appears. See the image below.
2
1
3
7
6 4
8
5
10 11
9
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The following edit screen is visible when viewing phases with microwave steps.
13
12
14
15
12. Name of current reagent in use. Touch the icon to display a list of reagents and choose one, as
shown in the figure below.
Before changing any program, please remember never to change the ramping times, the
heating rate (max power) and the default stirrer speed.
Should any of these parameters be modified, contact your local application support from
your supplier.
15. This icon allows setting up a TIME at POWER procedure. It is possible to set: Stirrer Speed, Fixed
Power and Max Temperature, as shown in the figure above. Let default value set to 0°C, if control of
Max Temperature parameter is not required. Entering of any value causes starting of an audio alarm
if this value is exceeded during a test/run.
Leaving the Max Temperature parameter set to 0°C, i t is equivalent to letting the unit run at
the default value of 120°C.
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Select the program to be deleted by touching and holding the touch until a new screen appears.
In this screen cancel a program by pressing “Delete Program”, resulting in removal of the stored user
program.
In this screen it is also possible to edit programs that have been already modified or
created. Any change made to an existing program will not be overwritten, but will create
an additional program, as indicated in the next chapter.
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Here are the instructions how to MODIFY an existing application already customized and listed under the
USER PROGRAMS icon.
First select the USER PROGRAMS icon. This will open the list of customized application programs.
Now select and keep holding the touch on the program to be delete (in this example Elastica Orcein icon),
until the EDIT screen appears.
If required, it is also possible to change the color of the TEXT and the BACKGROUND.
Now select the EDIT PROGRAM text box, as indicated above, to go into the EDIT SCREEN for changes to
the application.
The edit window in the next page shows extensive editing capabilities.
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3
1
2 4
6
5
8 9
Milestone s.r.l recommends that these instructions are kept near the instrument to
facilitate operations and better understanding of the software functions, especially when
operating the unit for the first time.
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Select OK to go to the application startup, showing the keyboard to enter the number of cassettes to be
processed.
Do NOT enter cassette numbers now, but select the HEART black icon positioned on the top left of the
screen.
The following screen appears, asking for confirmation that the application has to be added to the
FAVORITES. See below.
Selecting YES, the system goes back to the program ready to continue it, if required. If NOT, select the EXIT
icon and go to the Favorites screen. That adds the selected USER PROGRAM to the FAVORITES list.
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Select OK to go to the application startup, showing the keyboard to enter the number of cassettes to be
processed. Do NOT enter cassette numbers now, but select the HEART icon positioned on the top left of the
screen.
The following screen appears, asking for confirmation that the application is to be deleted from the
FAVORITES. See below.
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After deletion from the FAVORITES screen, the system goes back to the program ready to continue it, if
required. If NOT, select the EXIT icon and go to the Favorites screen.
Another way to delete a program from the FAVORITES screen is to enter into USER PROGRAM and follow
the instructions indicated in chapter 4.5 and delete as indicated.
If you DELETE any user PROGRAM as indicated above, this will delete that program from the FAVORITES.
4.8. Notes
This screen allows writing any notes required.
From the main screen below select NOTES, as indicated below.
The screen on the right appears and notes can be entered by using the keyboard.
Click on Home icon to go back to MAIN SCREEN on completion of notes, as shown above.
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4.9. Compliance
This function allows viewing that KOS complies with the CAP regulations.
From the main screen below select COMPLIANCE and the following messages appear.
4.10. Help
HELP function provides a series of useful information. From the main screen below select HELP.
The screen on the right appears showing:
Unit name, Serial Number, Software version (Engine, User Interface and Board) and other details (Technical,
Application and Sales Assistance and website), where available.
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If a USER is logged and is enabled to manage reagents, the following screen appears.
A User is allowed to open only:
• Reagent management, if authorized (see left figure).
If a USER is logged but is not enabled to manage reagents, the SETTINGS icon disappears in Main screen,
see right figure.
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1 2
3 4 5 6
8 9
1. Reagent: list of reagents available, touch the reagent icon to change the text display, if required.
2. Manage: touch this square icon to activate the reagent management for that reagent (indicated by
the color change to GREEN). Press this icon again to deactivate this management function
(indicated by the color change to grey).
3. Max Cassettes: this feature is activated by touch and opens the numeric keypad to enter the max
number of cassettes/slides to be processed.
4. Used Cassettes: when the number of cassettes/slides processed reaches the maximum value set,
the system alerts you to change the reagent required.
5. Reset: to be carried out by the operator when the max number of cassettes/slides processed has
been reached and the reagent has been changed. The operator is required to reset the value to zero
using the numeric keypad.
6. Delete: it is displayed as active, as shown below, when NEW reagents are added to the listing of
reagents. It is not active for preset reagents, as they are protected.
7. V and Λ: is the upward and downward scroll function of the reagent listing.
8. UNDO: to restore previous values in case a correction/editing is no more required.
9. SAVE: to save all changes made in the REAGENT MANAGEMENT screen.
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Select CREATE NEW USER icon: a New User is added to the User Management screen.
Select NEW USER icon: a keyboard is displayed on the screen.
Administrator has to enter NAME and PASSWORD for the New User (see JIM user in the example below).
Selecting the USERNAME box, enter the New User NAME, for example “JIM” using the numeric keyboard
and press the green arrowed check box to confirm.
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Selecting the PASSWORD box, enter the ACCESS CODE value, for example “123” using the numeric
keypad and press the green arrowed check box to confirm.
By selecting the three grey icons in the figure below, the ADMINISTRATOR can also give the user the
access to reagents management, to programs management and to set the user’s Favorites page as First
Page (icons turn GREEN when activated).
Select CLOSE EDIT PANEL in the figure above to exit the USER MANAGEMENT screen. In the following
screen select SAVE to make all the changes active.
On selecting SAVE the system will exit to the SETTINGS screen. This completes the process of creating a
users list.
Administrator is authorized to delete an existing user: go to USER MANAGEMENT screen, select the USER
icon to cancel and touch on DELETE USER icon, as indicated in the next figures.
On completion the system goes to USER MANAGEMENT screen. Select SAVE , as shown below.
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Touching any of the two dialogue boxes, a keyboard emulator appears, enter the text required.
3. Pre-soaking note: when activated (GREEN color), a reminder screen appears before any fixation
phase, reminding to perform pre-soaking in fixative (for example, see the chapter 3.1).
Touch this button to inactivate it (GRAY color); in this case the pre-soaking reminder screen will never
appear.
4. Rinsing Note: when activated (GREEN color), a reminder screen appears before any ethanol and
decalcification phase, reminding to perform a rinse (for example, see the chapter 4.2.2).
Touch this button to inactivate it (GRAY color); in this case the rinsing reminder screen will never appear.
5. Zip logs: when activated (GREEN color), all programs are stored in zip format. Touch the button to
inactivate it (GRAY color). In this case all programs are stored in xml format.
See the chapter 5.1 Export processing from the terminal to the USB.
6. For how to set the Network settings see the chapter 2.7.
When you make changes, the SAVE icon must be pressed before exiting the OWNER SETTINGS screen.
A message appears, press Ok and restart the Unit, as indicated in the figure below.
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Once activated it is not possible to press the REMOTE ASSISTANCE icon again (to avoid multiple
activations) until you reboot the machine.
At this point remote service works with your instrument.
Do not disconnect nor restart the instrument during the remote connection.
5. REPORTING
KOS provides the documentation necessary for the report activity of the Laboratory. In fact it is possible to
export a document including all necessary information like the real time and temperature performed by the
unit.
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From the MAIN SCREEN select LOG BOOK, selecting LOG BOOK the screen on the right appears.
This allows to export all the saved processed graphics: select the logs of interest and press the “Export
Saved processing” button.
Alternatively choose Delete selected or Delete ALL if you want to definitely eliminate one
file only or every file saved, respectively.
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If you have Microsoft Windows Vista or better installed on your PC, the ReportViewer
software is not needed.
• Plug the USB memory stick where the processes are stored and copy them on the key.
• Open the LogViewer software (going to “Start Menu\All programs\Milestone srl\Milestone LogViewer”
or clicking on the “LogViewer” icon created on your desktop).
HELP FILE: select “Help” and “How to” from the menu to view detailed instructions about
the software.
• Plug the USB key in your PC and select ”Open” icon to import a single process.
• Selecting ”Open” icon appears the following screen. Select the USB key with the process stored 1,
select the single process 2, then press “Open” 3.
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• The fields describe the data of interest such as: phases done, starting time, reagent used and
number of cassettes. Click directly on one curve to enlarge it, or on the arrows to view next phases.
• Once the file has been opened, preview/printing of the curves is possible by selecting the
appropriate buttons as below:
Printing of Process Data, Current Phase, All Phases in full or compact view is possible by pressing the
respective button.
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• Modification of the heading of the pages, edit of the label is also possible under “Printing options”
menu.
• Select one run and press “Print process data” or “Print current phase” to print out the curve (red
Circle). Press “Print ALL phase “ icon, choose the “complete” (one phase – one page) or the
“compact” (one page) format to print out the whole processing.
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Milestone s.r.l. MM073-004 – KOS – Operation Manual
6. MAINTENANCE
6.1. Introduction
Maintenance of KOS is carried out at two levels:
The FIRST is at laboratory level: a simple routine maintenance can prevent the likelihood of more serious
problems. Minimal routine maintenance is required by laboratory personnel that use KOS. The following
procedure is recommended to ensure optimal performance of KOS.
The SECOND level of maintenance is technically more detailed and is beyond the scope of normal
laboratory personnel. The unit requires once a year a technical preventive maintenance to maintain the high
performance and prevent any malfunction.
The paraffin level volume must be ready for use with up to 3 layers of cassettes.
The level of wax should reach the limit indicated on the glass (rack included, for any number of cassettes
processed) and it must not exceed that level. To achieve the proper level of paraffin, you must enter
approximately 0.7kg (1.54lb) of paraffin.
If you use the rack 4K, the correct level of paraffin is approximately 1cm (0.39 inch) above the cassettes.
On completion of run and removal of rack, top up wax level due to tissue absorption and carry over loss from
rack.
4. Check the reagent quality and change them when expired or dirty.
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Fill it up with approx. 2 liters of cleaning solution (ex. Iso-Paraffin such as Regenx®, or
MicroClean® in Europe or Clear Rite3® in USA or xylene or equivalent WAX cleaning as a
sort of aromatic alternative) enough to cover all the three layers.
2. Now agitate the rack by moving it up and down until it is completely clean.
3. Take the rack out from the container and dry it using normal laboratory wipes.
4. Alternatively, let the solution evaporate from the rack placing it under the fume hood.
5. Check that the rack is clean and, if required, repeat the sequence as described above.
6. Afterwards rinse the rack into alcoholic solution.
It is possible to clean the rack inside the HistosMATE instrument (Milestone s.r.l.).
XYLENE to clean the rack is NOT allowed when using the HistosMATE.
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6.3. Weekly
Check that the infra-red temperature sensor surface is not dirty.
Wipe out the inner surface of the Microwave unit with Isopropanol to remove any residues of dirt.
6.4. Monthly
Replace wax if severely contaminated by reagent or physically dirty
In case your KOS is connected to an external fume extractor or to a fume hood, these two filters should be
changed EVERY YEAR.
Otherwise, if there is no external fumes extractor, we recommend to change them EVERY 6 MONTHS.
How to proceed:
• The charcoal filters are positioned on the lateral side of KOS (see the figure below).
• Remove the panel by hand and then the two filters.
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6.6. Yearly
Call your SERVICE support for preventive maintenance contract.
Replace (yearly or whenever the ring shows signs of damage) the red sealing ring (Ref. P/N 67424) of the
GPR/K cover.
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7. TECHNICAL TROUBLESHOOTING
The following table provides the KOS operator and service technician with possible causes in the event a
problem develops with the unit.
PROBLEM DIAGNOSIS
Difficulties in switching on the Touch Control: -Repeat switching Off/On the MAIN Kos SWITCH on
display dark or fully lightened or crossed by the unit.
vertical and horizontal lines.
The unit does not switch on. -2 Fuses 8AT-250V power mains grid or 2 Fuses
15AT-125V (6.3 x 32mm).
-Check if you power to the unit from the power line.
Main Switch broken. (Service technician).
There is no microwave emission. -The door of the unit is not well closed.
-Heating transformer. (Service technician).
-Door-handle switches. (Service technician).
-The magnetron or its fan is malfunctioning which
causes magnetron overheating and activation of the
temperature sensor located on it. (Service
technician).
After 5 seconds magnetron heating time the -The door is not perfectly closed.
program does not start and the display shows -Door-handle switches. (Service technician).
“DOOR NOT CLOSED”.
Temperature Alarm Display. -Check the correct positioning of Histomodule.
-Check the presence of the stirrer.
-Check the correct reagent volume level in use.
Humidity Vapor Alarm Display. -Check the presence of the histomodule lid and that
is in correct position.
-Check the presence of the stirrer.
Solvent Vapor Alarm Display. -Check the presence of the histomodule lid and that
is in correct position.
-Check the presence of the stirrer.
Here is a list of errors that may appear during KOS processing. You will be asked to ignore any warning that
appears or not, to decide whether to continue or stop the phase of the process.
ERRORS DESCRIPTION
COM error Shut down and restart the machine. If the problem
persists, contact your Service support.
Communication error, please reboot Shut down and restart the machine. If the problem
persists, contact your Service support.
Communication error, the application is running Shut down and restart the machine. If the problem
without the Engine component. If this is not intended persists, contact your Service support.
for administration purposes, please restart.
Delta T Limit Reached The difference between the preset temperature
and the real temperature exceeds 10°C.
Temperature exceeds tolerance limits The temperature measured during a process
exceeds the tolerance limit of 130°C.
Door open, close and click Ok to continue The door of KOS is open and it is necessary to
close it to continue the process.
Humidity Sensor Alarm The humidity measured during a process exceeds
the setting limit.
MW Leakage Sensor Alarm The MW leakage measured during a process
exceeds the setting limit.
Organic Solvent Sensor Alarm The organic solvent concentration measured
during a process exceeds the setting limit.
The exhaust fan speed is too low Shut down and restart the machine. If the problem
persists, contact your Service support.
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2. As a general rule, user must take in consideration that each additional 1mm thickness will require about 1
hour processing (for example: 1mm takes 1 hour; 2mm takes 2 hours, 3mm takes 3 hours).
Universal biopsy cassette can accommodate up to 5mm thick samples. Make sure that the thickness is
the one specified for the processing protocol selected.
Milestone has developed the CheckLITE, a user-friendly, non-contact device that automatically signals
with a green light when the specimen is cut at the desired thickness. For further information on CheckLite,
contact Milestone s.r.l. at medical@milestonesrl.com or your local distributor.
1. With Milestone technology, different types of specimens can be simultaneously processed (kidney, heart,
colon, liver) in the same run. The time at temperature pre-stored protocols are suited for the most
sensitive tissue.
2. Specimens with different thickness but all up to 3mm can be simultaneously run. While the temperature is
set for the most sensitive tissue, the processing time is set for the thickest specimen. This means that, if
1, 2, 3mm thick specimens are to be processed together, the 3mm protocol must be selected.
3. Biopsies of ≤ 1mm thickness (like renal or gastric biopsies) require separate processing, because of their
small size, for that purpose we have developed the Transplant programs.
Fatty tissues
Fatty tissues are some of the most difficult tissues to process. Milestone s.r.l. has patented a very effective
reagent, the JFC solution (Ethanol, Isopropanol and long chain Hydrocarbon) which, in combination with
microwaves technology, assures best results. For further information on JFC Solution, contact Milestone s.r.l.
at medical@milestonesrl.com or your local distributor.
8.2. Fixation
Fixation is the all important first step of tissue processing. Tissues that have not been optimally fixed can
give bad morphology and processing artifacts.
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8.3. Beware
The use of inserts like sponges or thick paper or the use of small mesh cassette negatively influences the
correct flow of the reagent through the cassette. Use only insert of lens paper or cassette with large mesh to
allow proper unobstructed flow of reagent.
In the case sponges are used, increasing of the Ethanol, JFC Isopropanol and WAX
processing time by half of the preset time is recommended.
YES
NO
The use of Nylon made cassettes (like Mesh Cassettes shown in the picture below) in our microwave units
must be avoided.
NO
If you are already using particular kind of cassettes, please contact either our application
support: application@milestonemedsrl.com with details of the type of cassettes utilized,
so that we can check whether they are suitable to be used in our microwave units.
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8.4. Reagents
Make sure to follow the software reagents’ reuse settings (please refer to chapter 4.11.1). Check them daily
to minimize inconsistent results.
Purity of reagents:
1. When the water concentration in the reagents is more than 3% volume, a progressive loss of dehydrating
effect takes place. This problem can be caused by an overshooting limit of “maximum number of cassette
to process” or “Max number of processing cycle to use” for the respective reagents.
2. Insufficient cleaning of the rack after processing can contaminate reagents with traces of WAX.
WAX:
1. Can be reused several times because is left uncontaminated after every protocol.
Make sure to follow the software WAX’ reuse settings.
Milestone s.r.l. has collected some cause/effect scenarios that affect tissue quality. For further information
see MW tissue processing troubleshooting guide and MW decalcification troubleshooting guide pag. 93 and
100.
1. Ethanol-Isopropanol recommended as the standard routine method for small to medium-large size
biopsies.
2. Fat content of the tissue is kept to a minimum (< 2mm thickness).
3. Very Cost effective for general tissue-processing.
4. Strongly recommended for processing of Renal/Gastric, breast core biopsies and equivalent tissue
size.
JFC-Isopropanol-WAX
1. JFC-ISO sequence is strongly recommended for high fat content such as Breast / Lipoma up to full
size cassette in less than 4 hours.
PROWAVE-WAX
1. PROWAVE is a “one step” solution that can be used for tissues where overnight fixation time is
uncertain, since PROWAVE can also act as a secondary fixative.
2. Ideally suited for non-fatty tissues (up to 5mm thick) or moderate lipid content tissues (up to 3mm
thick).
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FRESH TISSUE
One step
Microwaving in Formalin JFC routine Ethanol
5 min. ramping time to 50°C
10 min. holding at 50°C
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DECALCIFICATION GUIDELINES
PARTIALLY FIXED
BONE MARROW
BIOPSY
Microwave Fixation
complete phase 30’ 50°C: Small biopsy (1.8mm)
Microwave decalcification
EDTA 10%(pH 7.2-7.4) EDTA10% (pH7.27.4) FORMIC 10% 37°C FORMIC 10% 50°C
37°C 50°C
18 hours 3.5 hours 1.5 hours 1 hour
All above are indicative time-range for generic small biopsies of 1.8mm.
Milestone anyway recommends that checking of the bone samples during a decalcification program is done
at least at half of the above time. So that user can better define optimum protocols for its samples.
EDTA 10% (pH 7.2-7.4): recommended solution for optimal morphology, IHC and molecular biology.
Microwave decalcification with both EDTA and Formic acid leads to satisfactory morphology, IHC and
molecular biology but it’s of paramount importance not to over-decal tissue, hence check of the bones’ status
must be consistently performed.
When the users decide to make their own protocols, temperature above 50°C should be avoided.
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A. APPENDIX
A.1. MW tissue processing troubleshooting guide
Pyknotic nuclei and 1. Tissue has been poorly fixed and 1. Tissues to be fixed overnight in formalin, if
severe cytoplasmic processed exclusively with JFC using JFC exclusively. Introduce an ethanol
solution (JFC is NOT a fixative). microwave step to post fix tissues with
distortion of the tissue ethanol, prior to using JFC.
section. OR
Use Ethanol-Isopropanol processing.
Poor dehydration.
2. Water contamination of microwave 2. Replace used microwave ethanol with fresh
Tissue sections have the ethanol step due to carry over of water 100% ethanol (pure or reagent grade).
microscopic appearance of from rinsing alcohols or the quality of AND
pyknotic nuclei and severe ethanol in use with microwave is less Implement regular checks of ethanol with a
cytoplasmic distortion than 100% (poor dehydration). Hydrometer, to ensure that microwave
(overheated appearance). ethanol is 100% quality (water free).
Opaque white surface 3. Water carry over is increased in rinsing 3. Introduce an extra (third) ethanol rinse to
appearance and softness of alcohols by the use of sponge biopsy ensure sponge pads are well cleansed.
some areas of the block after pads (poor dehydration).
the trimming.
4. For small biopsy samples: inadequate 4. For small biopsies with biopsy wraps: do not
dehydration due to use of paper wraps use the small biopsy run but instead increase
that restricts the flow of reagents. the processing time in the ethanol and
For larger biopsies: processing time Isopropanol to compensate for the wraps
selected is inadequate for dehydration. restricting reagent flow.
AND
For larger samples sizes: increase the
processing time.
Specimens partially or 1. Processing time is inadequate for the 1. Select the correct processing time, or
tissue size selected, resulting in select longer processing time for the
completely detached incomplete dehydration/clearing and sample size.
from surrounding WAX impregnation.
WAX.
Tissues that retain any of the solvent will
Tissue block surface appears escape by next day, producing this effect,
to collapse “Dry back” and varying according to the size.
samples appear partially or
completely detached from
surrounding WAX when the
tissue is observed the next
day.
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Inadequate Clearing of 1. Processing time for tissue is 1. Select the correct processing time, or select
fat. inadequate for the size selected, longer processing time for the sample size.
resulting in incomplete removal of fats, AND
The block face has a especially from fatty specimen blocks, Reduce tissue thickness when preparing wet
“greasy” feeling. such as breast. This can be seen when tissue blocks, if reducing processing times is
processing the larger blocks, where not desired.
Tissue block difficult to processing times become more critical
section. to accommodate the larger sizes.
When section placed on 2. Use of isopropanol as clearing agent 2. Use JFC as the alternative clearing agent.
water bath the section for fatty tissues is inefficient for the AND
breaks up. removal of fats, especially the larger Significantly reduce tissue block thickness
blocks of breast. (50%) as well as increase WAX impregnation
Softness of some areas of time (compromise method, not recommended
the block after the trimming. as it may be impractical to implement
routinely).
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Collapse of block 1. Tissue has been sufficiently 1. Retrospectively increase WAX impregnation
upper face after dehydrated and cleared (dry tissue) time by melting the block down and placing it
allowing sections to be cut, however into molten WAX in a WAX oven for
sectioning. WAX impregnation is not entirely convenience. At least an hour.
complete with residual amounts of the AND
Tissue block surface appears previous solution remaining. Prospectively increase standard WAX
to collapse “Dry back” when impregnation times. Approx. 30 minutes for
the tissue is observed the Indicated by continued bubbling originating the longest processing program. For the
next day. from the tissue blocks in the final stage (near shorter processing programs approximately
the end) of the WAX program. 15 minutes increase in WAX time.
This occurs even though you
have easily cut a section of Does not occur in smaller blocks, but may
the block from the previous appear as tissues increase in size. The
day. result is that tissues that retain any of the
solvent will escape by next day, producing
Tissue block not difficult to this effect, varying according to the size.
section the same day.
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White appearance of 1. Tissue has been sufficiently 1. Retrospectively increase WAX impregnation
block face. dehydrated and cleared (dry tissue), time by melting the block down and placing it
however WAX impregnation is not into molten WAX in a WAX oven for
Tissue block surface looks complete. convenience.
unprocessed after trimming AND
the block (opaque white Indicated by continued bubbling originating Increase standard WAX impregnation times
surface). from the tissue blocks in the final step of the for future processing runs.
WAX program.
Section can be easily cut and
when placed on water bath it Can be seen when processing larger blocks,
does not explode. where times become more critical to
accommodate the larger sizes.
“DRY” feel of block face in
unprocessed areas, usually in
the centre of the larger
blocks.
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Pigment deposits in 1. Hemorrhagic tissue that has not been 1. Confirm that the pigment is actually formalin
microscopic section. adequately fixed (stabilized) will display pigment and not hemosiderin (Iron break
deposits of formalin pigment at sites down products of red blood).
Microscopic picture shows where there are abundant red blood AND
pigment deposits cells. To remove pigment retrospectively, if it
(black/brown) at sites of interferes with diagnosis, then use the
hemorrhagic deposits (Blood Present in tissues with hemorrhagic sites standard formalin pigment removal treatment
vessels, Spleen and products such as major blood vessels, where there method that uses Picric Acid.
of conception). are abundant red blood cells and related AND
breakdown deposits, this especially includes Prospectively, to avoid this from occurring is
the Spleen. to ensure that hemorrhagic tissue is well fixed
before by microwave fixation or conventional
fixation, before microwave processing.
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Fatty tissue collapses BEFORE 1. Tissue size is too large for adequate 1. Ensure that tissue fixation for the larger tissue
in block and fixation to occur and stabilize the tissue blocks has been performed conventionally for
to withstand subsequent exposure to at least overnight, or with microwave fixation
microscopic section. reagents, such as JFC. prior to microwave processing: don’t assume
tissue is well fixed when dealing with larger
Macro: fatty tissue block size samples.
structure size looks much AND
smaller than the original piece If using JFC as the only processing agent,
placed in the cassette then change to a program that utilizes JFC
(appears collapsed). followed by Isopropanol, where Isopropanol
helps stabilize fatty cell structure.
Micro: the fatty section does AFTER
not that honeycomb 2. Present in larger fatty tissue blocks 2. Use of Isopropanol as the last reagent step
appearance of fatty cells and where there is an absence of before WAX infiltration will reduce the risk of
instead the fat cells are connective tissue parenchyma to hold fatty cell collapse, so a preset protocol for
collapsed into themselves fat cells in place: connective tissue fatty tissue should employ Isopropanol or
(squashed together). provides a framework to support fatty ProWave as the last reagent step prior to
cells in place. WAX infiltration
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Inadequate 1. Section was not placed in decalcifying 1. Ensure that tissues containing calcium are
decalcification: solution before processing. placed in decalcifying solution.
Areas of the tissue section 2. Section was left in decalcifying solution 2. Surface decalcification by carefully facing the
containing unremoved for too little time. block and then treating the exposed face with
calcium. the decalcifying solution. The block after must
be rinsed well and the first ribbon taken.
Appearance of dark blue AND
areas in the trabeculae. Check the end point of decalcification
carefully, use radiography if necessary to
determine completeness of decalcification. A
manual instrument can be a needle.
AND
Increase standard DECALCIFICATION times
for future decalcifications.
1. Section left in decalcifying solution for 1. Rigorously monitor the end point of
Excessive too long time. decalcification using radiography if necessary
Decalcification: or a manual needle.
Loss of nuclear detail and 2. Section not well fixed before placing in 2. Ensure good fixation before placing sections
nuclear staining. decalcifying solution. in decalcifying solution.
Decrease in basophilic
staining properties.
A.3. Summary
Problem Cause Remedy
Pyknotic nuclei and severe cytoplasmic Poorly fixed. Extend fixation time.
distorsion Poor fixation/JFC reaction. Use JFC/Isopropanol program.
Poor Dehydration Alcohol contamination (water). Replace alcohol.
Use of sponge Pads/ inefficient biopsy Pads. Extend processing time.
Use sponge alternatives.
Processing cycle too short. Use appropriate size processing cycle.
Specimens detached from surrounding WAX Processing cycle too short. Use appropriate size processing cycle.
Reduce tissue block thickness.
Incomplete Clearing of fat Processing cycle too short. Use appropriate size processing cycle.
Reduce tissue block thickness.
Isopropanol inefficient for fat clearing. Use JFC as alternate clearing agent.
Reduce tissue block thickness.
Dehydration/Clearing agent reuse life exceeded. Replace Dehydration or Clearing reagent.
Collapse of block face after sectioning WAX infiltration not entirely complete. Increase WAX infiltration time.
White appearance of block face WAX infiltration not entirely complete. Increase WAX infiltration time.
Pigment deposit in sections Incomplete fixation of blood. Perform pigment test to exclude whether formalin
pigment or hemosiderin deposits.
Include MW fixation or extend conventional fixation time.
Fatty tissue collapse in blocks & microsections Inadequate fixation of tissue, reacting with JFC. Fix tissue conventionally overnight or include MW
fixation.
Use JFC followed by Isopropanol protocol for processing.
Absence of connective tissue parenchyma to Use JFC followed by Isopropanol protocol for processing.
support delicate fatty network structure.
Inadequate decalcification Not decalcified before processing. Use decalcifying solution for bones
Decalcification time too short. Surface decalcification of blocks.
Check the end point of decalcification.
Extend decalcification time.
Excessive Decalcification Decalcification time too short Check the end point of decalcification.
Poorly fixed. Extend fixation time.
B. APPENDIX
B.1. How to manage samples while an alarm is occurring during histoprocessing
1. Never leave samples in open air or under fume hood, to avoid drying.
2. Put samples as quickly as possible into an external container with one of the following reagent in a
quantity sufficient to cover all samples:
3. Check the wetness level of at least 10% of samples (in different parts of the rack). If wetness level
appears: