Milestone BoneSTATION User manual

BoneSTATION
Fixation/Decalcication System
Operator Manual - MM093

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Thank you for choosing one of our systems and welcome to the increasingly crowded club of Milestone
laboratory instrumentation users.
We feel confident that you will be fully satisfied adding this new device to your laboratory.
We recommend you read this operator manual carefully and always keep it within reach for convenient and
quick referencing.
For any clarification or request for assistance, please contact our representative in your country:
Or contact
Milestone s.r.l.
Via Fatebenefratelli, 1/5
24010 Sorisole (BG) Italy
Tel. +39.035.412 8264
Fax [phone]
web site www.milestonemed.com
e-mail [e-mail]
Read this manual carefully before using the instrument.
MM093-002 –BoneSTATION –Operator Manual
2019-09

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SUMMARY
SUMMARY ........................................................................................................................................................ 4
1. INTRODUCTION........................................................................................................................................ 6
1.1. Symbols used .....................................................................................................................................6
1.2. Designated use...................................................................................................................................7
1.3. Technical specifications......................................................................................................................8
1.3.1. LCD Touch Screen .................................................................................................................... 8
1.4. Transportation and storage conditions ...............................................................................................9
1.5. Warning information..........................................................................................................................10
1.5.1. Personal Data Safety............................................................................................................... 10
1.6. Instrument label ................................................................................................................................11
1.7. Compatible reagents.........................................................................................................................11
1.8. Waste disposal of the equipment .....................................................................................................12
1.9. Waste disposal of the reagents ........................................................................................................12
1.10. Return for repair to manufacturer .....................................................................................................13
2. SETTING UP THE INSTRUMENT........................................................................................................... 14
2.1. Space requirements..........................................................................................................................14
2.2. Unpacking and check list..................................................................................................................14
2.3. Placement.........................................................................................................................................16
2.3.1. Device overview....................................................................................................................... 16
2.4. Power supply ....................................................................................................................................17
2.4.1. Switch on the BoneSTATION.................................................................................................. 18
2.5. Reagents...........................................................................................................................................18
3. USING BoneSTATION............................................................................................................................. 19
3.1. Prepare the histomodule...................................................................................................................19
3.2. Run Fixation and Decalcification programs......................................................................................21
3.2.1. Fixation .................................................................................................................................... 21
3.2.2. Decalcification.......................................................................................................................... 29
3.3. Run only a decalcification program ..................................................................................................31
3.4. Run only a fixation program..............................................................................................................31
3.5. Sample zone.....................................................................................................................................32
4. REAGENT MANAGEMENT ..................................................................................................................... 33
5. SETTINGS................................................................................................................................................ 34
5.1. Owner ...............................................................................................................................................34
5.2. Reagent list.......................................................................................................................................35
5.3. Date/time...........................................................................................................................................35
6. MAINTENANCE ....................................................................................................................................... 36
6.1. Daily..................................................................................................................................................36
7. GOOD LABORATORY PRACTICE FOR BONE DECALCIFICATION.................................................... 37
7.1. Guideline for the bone samples fixation ...........................................................................................37
7.2. Decalcification guidelines .................................................................................................................38
7.2.1. Protocols for decalcification of bone marrow biopsies 1.8mm ................................................ 39
7.2.2. Protocols for decalcification of bone marrow biopsies 5mm ................................................... 40
7.3. How to create a decalcification protocol...........................................................................................41
8. REPORTING............................................................................................................................................ 42
8.1. Display a process on the BoneSTATION .........................................................................................42
8.2. Export processing data from the terminal.........................................................................................43
8.3. Events Log from the terminal to the USB key...................................................................................44
8.4. Install and operate with LogVIEWER ...............................................................................................45
8.4.1. Open process........................................................................................................................... 47
8.4.2. Print process............................................................................................................................ 48
8.4.3. Send process to customer support (Milestone)....................................................................... 48
8.4.4. Change settings....................................................................................................................... 49
8.4.5. Other functions......................................................................................................................... 49
9. OPTIONAL AND SPARE PARTS ............................................................................................................ 50
9.1. Decalcification/Fixation module - CODE 67710 ...............................................................................50
9.2. Rack 16 mega cassettes for BoneSTATION - REF 67850 BNS R16MC.........................................51
9.3. Rack 30 cassette for BoneSTATION –REF 67854 BNS R30C.......................................................52
9.4. Rack 6 super mega cassette for BoneSTATION –REF 67855 BNS R6SMC .................................53

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9.5. Internal Divider BoneSTATION / BoneSTATION ONE - REF 67860 BNS RIDLS...........................54
9.5.1. How to use the Internal Divider................................................................................................ 55
9.6. MoL-DECALCIFIER Tank 5L (Ready to use solution) –REF 51413...............................................56
9.7. Magnetic touch pen - CODE 50597/M..............................................................................................56
9.8. Glass containers - CODE 67724 ......................................................................................................56
9.9. Power cord for devices at 230V50/60Hz (Schuko) - CODE 50036...............................................57
9.10. Power cord for devices at 115V60Hz (NEMA 5-15) - CODE 50391 .............................................57
A. APPENDIX........................................................................................................................................... 58
A.1. How to manage an alarm..................................................................................................................58
The manufacturer reserves the right to change and/or improve specifications without
notice and without incurring any obligation.

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1. INTRODUCTION
1.1. Symbols used
Read carefully this instruction.
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.
Flammable reagent.
Potentially corrosive substance/reagent
Potentially danger for aquatic environment substance/reagent
CE logo: this instrument complies to European Community directives.
IVD medical device according to 98/79/EC directive.
Specifies the manufacturer’s serial number.
Specifies the manufacturer’s reference code.
Replaceable fuse
Fragile
WEEE European directive symbol (2012/19/EC):
Electric/electronic device do not throw out in the environment.
Manufacturer.

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1.2. Designated use
BoneSTATION and its accessories have been developed for laboratory use and can therefore withstand the
harshest laboratory conditions for continuous use in Histological sample preparation procedures.
The instrument is intended for laboratory use (indoor use) only.
BoneSTATION is specifically designed to execute these processes for histopathological applications:
•Fixation
•Decalcification
BoneSTATION must be operated exclusively with the reagents listed in section Compatible reagents chapter
1.7.
Any other use of the instrument should be deemed as misuse and voids the
manufacturer's warranty.

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1.3. Technical specifications
REF 67700 BoneSTATION Power Supply input: 230V~ 50/60Hz –340W
REF 67701 BoneSTATION Power Supply input 115V~ 60Hz –340W
- Working Temperature:15°C–30°C (59°F–86°F)
- Humidity (relative): up to 80%
- Maximum altitude: 2000m
- Dimensions: Width: 340mm (13"), Height: 410mm (16"), Depth: 495mm (19")
- Total Weight: 18kg (40lb)
- Only internal use.
1.3.1. LCD Touch Screen
BoneSTATION touch screen LCD is displayed in the image below. Simply just touch the icons on the screen
to operate the system.
- Characteristics: TFT-LCD 7” widescreen colour display
Resolution 800X480,
Resistive Touch screen
Mass storage MicroSD 4GB
CPU 1GHz
Windows™ Embedded Compact 7
I/O-Interface: 1x USB port 2.0, 1x LAN Ethernet 10/100 Mbps RJ-45.

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One USB port is located on the right side of the device (see image below).
1.4. Transportation and storage conditions
- Temperature: –20°C up to +60°C (-4°F up to 140°F)
- Humidity: up to 80% (up to 50% at 40°C (104°F)) non-condensation

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1.5. Warning information
This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may
cause radio interference; in this case you may need to take measures to mitigate the interference.
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 and before cleaning.
Equipment shall be connected to a main power socket outlet which is accessible and visible by the operator.
Equipment is provided with replaceable fuses; however, their replacement is to be performed by properly
authorized SERVICE personnel. If the system is still not properly working, contact the local authorized and
trained SERVICE representative or the manufacturer.
All parts of the equipment and all optional parts must be supplied only by the manufacturer.
DO NOT OPEN THE CHASSIS. Failure to follow the instruction in the documentation
might lead to a reduction of device safety. If the equipment is not working properly
contact your supplier or the manufacturer.
Do not remove the instrument 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.
Use only the reagents listed in chapter 1.7 Compatible reagents, to avoid damage to
the instrument. Failure to follow the instructions in the documentation might lead to
a reduction of device safety.
Use caution when handling histomodules containing hot reagents.
Be careful: exhaust reagents are toxic and carcinogenic.
Handle with care and follow the local standard regulations.
1.5.1. Personal Data Safety
The Device described herein is not intended for managing personal data of natural persons. Personal data of
natural persons shall not be inserted into the Device during the use of the Device. The organization that uses
the Device shall implement appropriate measures to ensure that no personal data of natural persons is
inserted into the Device. All the data referring to a person and inserted into the device shall use, at least, the
“pseudonymization”, in such a manner that the personal data can no longer be attributed to a specific data
subject without the use of additional information, provided that such additional information is kept separately
and is subject to technical and organizational measures to ensure that the personal data are not attributed to
an identified or identifiable natural person.

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1.6. Instrument label
MILESTONE SRL
Via Fatebenefratelli, 1/5 –24010 Sorisole (BG) –ITALY
Tel. [phone]
Fax. [phone]
BONESTATION
SERIAL NUMBER YYWWRRNNN
FUSES
XXXAT 5X20
INPUT
MANUFACTURED:
For symbols explanation see chapter 1.1.
1.7. Compatible reagents
FIXATIVES
DECALCIFIERS
Milestone FineFIX®
Ethylenediaminetetraacetic acid (EDTA) max 20%
Formalin, buffered or
unbuffered
Formic acid max 20%
Acetic acid max 10%
Hydrochloric acid max 10%
Nitric acid max 10%
Trichloroacetic acid max 10%
DO NOT USE REAGENTS DIFFERENT FROM THOSE LISTED ABOVE.
For any clarification contact: [e-mail].

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1.8. Waste disposal of the equipment
It is recommended to use polyphenolic based disinfectants or chlorine substitutes to clean and disinfect the
instrument. Alternatively use of a solution of 1:10 Bleach (recommended by the CDC for disinfecting) is also
allowed to decontaminate the instrument.
For further information, contact [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 the reagents
For further information refer to the SDS (Safety Data Sheet) provided by your supplier.
Do not remove the side panels of the device during cleaning operations.
Disconnect the power supply before any operation.
Do not use direct or high-pressure water to clean the instrument.
For safety reason, any operation without the individual protective devices must be
avoided.
Handle with care and store in a cool dry space using a tightly closed container.
Vapours may collect in empty containers. Treat empty containers as hazardous.
Waste material should be disposed of in an approved incinerator or in a designated landfill
site, in compliance with all federal, provincial and local government regulations.
Some reagents can have potential health effects and cause environmental pollution if not
correctly disposed.

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1.10.Return for repair to manufacturer
This instrument is an in-vitro medical diagnostic device and it is usually installed in a laboratory where
samples and other biological tissues are present. For your safety, it must therefore be cleaned and
disinfected before use, and gloves must be worn when using this instrument.
You must wear gloves when operating the system.
If the device needs to be returned to Milestone s.r.l. for repairs, the device must be cleaned up and
disinfected prior to shipment (refer to chapter 6). Any devices that have not been disinfected will not be
accepted and you will be contacted with regards to disinfection cost. In accordance with international health
standards, biohazard materials must be shipped in appropriate packages (risk of fines).

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2. SETTING UP THE INSTRUMENT
Before switching the device on (when coming from a storage area), allow the
instrument to reach environment operating conditions (at least 30 minutes).
2.1. Space requirements
Device dimensions:
Width: 340mm (13in)
Height: 410mm (16in)
Depth: 495mm (19in)
Space dimensions required to locate the device:
Width: 440mm (17in)
Height: 420mm (16.5in)
Depth: 590mm (29in)
Place the instrument under a fume hood, in order to protect the operator and the
environment by fumes/vapours from the fixation and decalcification reagents loaded in
the glasses.
2.2. Unpacking and check list
BoneSTATION is delivered in a wood box (weight 30kg - 66.14lb) with these dimensions:
Width 430mm (16.9in)
Depth 680mm (26.7in)
Height 680mm (26.7in)
When unpacking, check that all parts correspond to the packing list included in the shipment. Utmost care
must be made during unpacking of BoneSTATION, to avoid any scratch or damage to the acid resistant
coating.
BoneSTATION COMPLETE PACKAGE (REF 67700 230V~ - REF 67701 115V~) includes:
1. Nr. 1 BoneSTATION (CODE 67703 230V~ - CODE 67704 115V~) including the following items:

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- Nr. 1 Operator Manual in electronic format
- Nr. 2 Glass containers
- Nr. 1 Magnetic touch-pen
- Nr. 1 Power supply cable, the following pictures show:
Power cord for devices at 230V50/60Hz (Schuko).
Power cord for devices at 115V60Hz (NEMA 5-15).
2. BoneSTATION starter kit (CODE 67705) includes:
A. Nr.2 Decalcification/Fixation modules
B. Nr.1 Rack for 30 standard cassettes (REF 67854 –BNS R30C)
For optional parts see the chapter 9.
The images shown are for illustrative purposes only.

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2.3. Placement
BoneSTATION can be positioned in its final place of use. Make sure it is firmly placed and the bench is level.
During the setup, BoneSTATION must be disconnected from the main power supply.
A correct location of BoneSTATION is under a fume hood.
Provide a bench of at least 44cm (17.3”) wide and 59cm (29”) deep and place BoneSTATION on it.
A proper location of BoneSTATION is under a fume hood.
2.3.1. Device overview
The picture below shows the front view of BoneSTATION system.
The device consists of:
•A FRONT MODULE: a stainless-steel ceramic coated hot plate.
•An INFRARED TEMPERATURE SENSOR installed behind the hot plate for non-contact temperature
measurement.
•A BACK MODULE: a holding position with magnetic stirrer for a second histomodule, WITHOUT
HEATING.
•A SAMPLE ZONE including two removable Petri glass containers. These items are all fully
washable.
•An LCD TOUCH SCREEN 7” user interface.
•A WARNING LAMP to warn users when the plate is hot.
•A Brushless magnetic stirrer.
FRONT
MODULE
HOT PLATE
BACK
MODULE
HOLDING POSITION
INFRARED
SENSOR
WARNING
LAMP
LCD touch
screen
SAMPLE
ZONE
GLASS
CONTAINER
GLASS
CONTAINER

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2.4. Power supply
•A ground connection must be present in the power line available in the lab to assure the device
works correctly (yellow/green, green or bare wire). Do not connect a Milestone device without ground
connection. Do not use the blue/white wire (neutral of power line).
•Power supply neutral has to be referred to ground.
•Power supply line wires (their size and distance from the switch board) used in the laboratory are
compliant with the power supply consumption indicated in the label positioned on the back side of
our devices.
•Plug/socket is visible during the normal use and easily accessible.
The power supply must be protected by a residual current circuit breaker with over current protection,
interrupt capability equal or more than 6000A, nominal current 10A, characteristic C-curve, residual current
30mA. Power line must have potential earth connection.
Before connecting the plug to the laboratory’s socket, check that the power supply
voltage of the device matches the power supply line of the laboratory.
Damages occur when wrong power supplies the instrument.
CONNECTING CABLES: Never connect or remove cables when power to the device is
switched on, this will avoid risk of damage.
Connect the power cord socket in BoneSTATION plug (on the back) and the power cord plug to main power
supply socket of laboratory.
Connection ports are positioned on the back side of BoneSTATION:
1. Ethernet/LAN plug
2. Two replaceable fuses
3. Main power supply connector input
1
2
3

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2.4.1. Switch on the BoneSTATION
Switch BoneSTATION on using the power switch located on the right side of the device front panel.
BoneSTATION is now ready for use.
2.5. Reagents
Complete the set up with reagents, by providing at least:
FIXATION REAGENTS:
•1L Formalin 10% or FineFIX.
DECALCIFICATION REAGENTS:
•1L MoL-DECALCIFIER or Formic acid 10%.

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3. USING BoneSTATION
This instrument is an in-vitro medical diagnostic device and it is usually installed in a
laboratory where samples and other biological tissues are present. For your safety, it
must therefore be cleaned and disinfected before use, and gloves must be worn when
using this instrument.
BoneSTATION has dedicated software, controlled by the LCD touchscreen terminal.
Heating power is auto-tuned by a PID controller. The operator must only set up the desired parameters
(Time and Temperature).
The device will always reproduce the same conditions of temperature in the set times, by automatically
adjusting the power level.
The following section shows how to run and modify the program values with BoneSTATION software. Use
the touch screen to select the desired menu.
3.1. Prepare the histomodule
Load the RACK with cassettes and position the CASSETTE FIXING DISC on top.
The fixing disc must always be used, in order to avoid possible spilling out of cassettes
from the rack during decalcification/fixation.
FIXING
DISC

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At the switch-on the BoneSTATION main screen appears.
Before starting a process,check that the reagent level is adequate. The correct level of reagent depends on
the number of cassettes used: the correct level is approximately 1cm (0.4 inch) above the cassettes:
•1LAYER: reagent about 800ml
•2LAYERS: reagent about 1300ml
When the reagent level is adequate to cover all the cassettes, position the glass in the metal holder, then put
the module in the correct position on the BoneSTATION, according to your needs either hot plate or holding
position.