bonestation - total tissue...

BoneSTATIONFixation/Decalci� cation System

Operator ManualMM093-001 (August 2013)

MILESTONEH E L P I N GP A T I E N T S

Milestone s.r.l. MM093-001 – BoneSTATION – Operation Manual

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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 [email protected]

Please read the user manual before using the device .


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SUMMARY SUMMARY ........................................................................................................................................................ 4

1. INTRODUCTION ........................................................................................................................................ 5

1.1. Symbols used ..................................................................................................................................... 5

1.2. Designated uses ................................................................................................................................. 5

1.3. Technical specifications ...................................................................................................................... 6

1.3.1. LCD Touch Screen .................................................................................................................... 6

1.4. Transportation and storage conditions ............................................................................................... 7

1.5. Warning information ............................................................................................................................ 8

1.6. Instrument label .................................................................................................................................. 9

1.7. Compatible reagents ........................................................................................................................... 9

1.8. Waste disposal of the equipment ..................................................................................................... 10

1.9. Waste disposal of the reagents ........................................................................................................ 10

2. SETTING UP THE INSTRUMENT ........................................................................................................... 11

2.1. Space requirements .......................................................................................................................... 11

2.2. Unpacking and check list .................................................................................................................. 11

2.3. Placement ......................................................................................................................................... 13

2.3.1. Unit overview ........................................................................................................................... 13

2.4. Power supply .................................................................................................................................... 14

2.4.1. Switch on the BoneSTATION .................................................................................................. 15

2.5. Reagents........................................................................................................................................... 15

3. OPERATE WITH BONESTATION ........................................................................................................... 16

3.1. Prepare the histomodule ................................................................................................................... 16

3.2. Run Fixation and Decalcification programs ...................................................................................... 18

3.2.1. Fixation .................................................................................................................................... 18

3.2.2. Decalcification .......................................................................................................................... 25

3.3. Run only a decalcification program .................................................................................................. 27

3.4. Run only a fixation program .............................................................................................................. 27

3.5. Working area .................................................................................................................................... 28

4. REAGENT MANAGEMENT ..................................................................................................................... 29

5. SETTINGS ................................................................................................................................................ 30

5.1. Owner ............................................................................................................................................... 30

5.2. Reagent list ....................................................................................................................................... 31

5.3. Date/time........................................................................................................................................... 31

6. MAINTENANCE ....................................................................................................................................... 32

6.1. Daily .................................................................................................................................................. 32

7. GOOD LABORATORY PRACTICE FOR BONE DECALCIFICATION .................................................... 33

7.1. Decalcification guidelines ................................................................................................................. 33

7.2. Bone marrow 1.8mm DECALCIFICATION PROTOCOLS ............................................................... 34

8. REPORTING ............................................................................................................................................ 35

8.1. Display a process on the BoneSTATION ......................................................................................... 35

8.2. Export processing data from the terminal ......................................................................................... 36

9. BONESTATION OPTIONAL ACCESSORIES ......................................................................................... 37

A. APPENDIX ........................................................................................................................................... 38

A.1. How to manage an alarm .................................................................................................................. 38


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1. INTRODUCTION

1.1. Symbols used

Please carefully read this instruction.

An instruction accompanied by this symbol provides a cautionary statement: WARNING. Failure to follow the instruction may enda nger 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 accide nts resulting from electric shock.

Biohazard.

Surfaces identified with this symbol are at danger temperature (more than 70°C/158°F).

CE logo: this instrument complies to European Commu nity directives.

IVD medical device according to 98/79/EC directive.

WEEE European directive symbol (2002/96/EC): Electric/electronic device do not throw out in the environment.

Potentially corrosive substance/reagent

Potentially danger for aquatic environment substanc e/reagent

Potentially flammable substance/reagent

1.2. Designated uses The Milestone 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. The Milestone BoneSTATION is specifically designed to execute these processes for histopathological applications:

• Fixation • Decalcification

The Milestone BoneSTATION must be operated exclusively with the reagents listed in section Compatible reagents chapter 1.7.

Any other use of the instrument is considered impro per and void the warranty provided by the manufacturer.


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1.3. Technical specifications Ref. P/N (67700) Power Supply input: 230V~ 50/60 Hz – 340W Ref. P/N (67701) Power Supply input: 115V~ 60 Hz – 340W Working Temperature: 15°C–30°C (59°F–86°F) Humidity (relative): up to 80% Maximum altitude: 2000m Only internal use. Dimensions: Width: 340mm (13"), Height: 410mm (16"), Depth: 495mm (19") Total Weight: 18 Kg – 40 lb

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 color display Resolution 800X480, Resistive Touch screen Mass storage MicroSD 4 Giga CPU 1GHz Windows™ Embedded Compact 7 I/O-Interface: 1x USB port 2.0, 1x LAN Ethernet 10/100 Mbps RJ-45.

The manufacturer reserves the right to change and/o r improve specifications without notice and without incurring any obligation.


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One USB port is located on the right side of the unit (see image below).

1.4. Transportation and storage conditions Temperature: -20°C (-4°F) up to +60°C (140°F) Humidity: up to 50% (at 40°C–104°F) non–condensing

Before turning BoneSTATION on (when coming from a s torage room), let the unit reach working environmental conditions (at least half an hour).


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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, please contact the local authorized and trained SERVICE representative or the manufacturer. All parts of the equipment and all accessories must be supplied only by the manufacturer.

DO NOT OPEN THE CHASSIS! Failure to follow the inst ruction 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 panels or cover. Only authorized and qualified SERVICE personnel may repair the instrument and acc ess the instrument’s internal

components.

It is important that normal standards for safety an d good l aboratory practices are applied. Always use common sense and the best known practice when operating the

instrument. Failure to follow the instructions in t he documentation might lead to a reduction of device safety.

The Competent Authority owning the instrument has p rimary responsibility for accident-free operation together with designated pe rsonnel 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 h ot reagents.

Be careful: exhaust reagents are toxic and carcinog enic. Handle with care and follow the local standard regu lations.


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1.6. Instrument label

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 ABO VE. For any clarification please contact: [email protected] .


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1.8. Waste disposal of the equipment In case this system needs to be returned to the manufacturer for any repair, it is necessary to clean and disinfect the unit before return. Non-disinfected devices will be no longer accepted and you will be contacted to pay the relative disinfection cost. International health rules require that shipments of biohazard materials are not done in standard packages (risk of sanctions).

It is recommended to use enzymatic detergents and polyphenolic based disinfectants or chlorine substitutes to clean and disinfect the instrument. 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, please contact the manufacturer: [email protected]. 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 verify the presence of a local empowered system for collection and disposal of WEEE. The in-observance of Directive 2002/96/EC or of the local law which acknowledges it can have potential effects on the environment and human health.

This symbol indicates separate collection for electrical and electronic equipment

If additional requirements on accident prevention and environmental protection exist in the country of operation, this instruction manual must be supplemented by appropriate instructions to ensure compliance to such requirements.

1.9. Waste disposal of the reagents

For further information please refer to the MSDS (Material Data Safety Sheet) provided by your supplier.

Do not remove the side panels of the unit during cl eaning operations.

Disconnect the power supply before any operation. Do not use direct or high-pressure water to clean t he instrument.

For safety reason, any operation without the indivi dual protective devices must be avoided.

Handle with care and store in a cool 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 an d local government regulations.

Some reagents can have potential health effects and cause environmental pollution if not correctly disposed.


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2. SETTING UP THE INSTRUMENT

2.1. Space requirements Unit dimensions:

Width: 340mm (13in) Height: 410mm (16in) Depth: 495mm (19in) Space dimensions required to locate the unit:

Width: 440mm (17in) Height: 420mm (16.5in) Depth: 590mm (29in)

Place the instrument under a fume hood, in order to protect the operator and t he environment by fumes from the fixation and decalcif ication 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. The BoneSTATION COMPLETE PACKAGE (Ref P/N 67700 230V~- Ref P/N 67701 115V~) includes: 1. Nr. 1 BoneSTATION unit (Ref P/N 67703 230V~- Ref P/N 67704 115V~) including the following items:


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Nr. 1 MM093 Operation Manual Nr. 2 Glass container Nr. 1 Power supply cable, the following pictures show:

A) Ref. P/N 50036: Power cord for units at 230 Vac 50/60Hz (Schuko). B) Ref. P/N 50391: Power cord for units at 115 Vac 60Hz (NEMA 5-15).

2. The BoneSTATION starter kit (Ref P/N 67705) includes:

A. Nr.2 Decalcification/Fixation modules (Ref. P/N 67710)

B. Nr.1 Rack for 30 standard cassette (Ref. P/N 67854)

REF. P/N 50036 REF. P/N 50391 A B


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2.3. Placement BoneSTATION unit can be positioned in its final place of use. Make sure it is firmly placed and the bench is level.

During the setup, the BoneSTATION must be disconnec ted from the main power supply.

Provide a bench of at least 44cm (17.3”) wide and 59cm (29”) deep and place the BoneSTATION on it. A proper location of the BoneSTATION is under a fume hood.

2.3.1. Unit overview The picture below shows the front view of the BoneSTATION system. The unit 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 WORKING AREA including two removable Petri glass containers. These items are all fully

washable. • A LCD TOUCH SCREEN 7” user interface. • A WARNING LAMP to warn users when the plate is hot. • A Brushless magnetic stirrers.

FRONT MODULE

HOT PLATE

BACK MODULE

HOLDING POSITION

INFRARED SENSOR

WARNING LAMP

LCD touch screen

WORKING AREA

GLASS CONTAINER

GLASS CONTAINER


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2.4. Power supply

• A ground connection is available in the lab to assure the unit works correctly (yellow/green, green or bare wire). Do not connect a Milestone unit 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 label positioned on the back side of our units. • Plug/socket is visible during the normal use and easily accessible.

Before connecting the plug to the laboratory’s sock et, check that the power supply voltage of the unit matches the power supply line o f the laboratory.

Damages occur when wrong power supplies the instrum ent.

The power supply must be protected by a residual cu rrent circuit breaker with over current protection, interrupt capability equal or m ore than 4500A, nominal current 10A,

characteristic C-curve, residual current 30mA. Powe r line must have potential earth connection.

CONNECTING CABLES: Never connect or remove cables w hen power to the unit is switched on, this will avoid risk of damage.

Connect the power cord socket in the BoneSTATION plug and the power cord plug to main power supply socket.

Connection ports are positioned on the back side of BoneSTATION:

1. Ethernet/LAN plug 2. Aux power outlet 3. Two replaceable fuses 4. Main power supply connector input

1 2 3

4


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2.4.1. Switch on the BoneSTATION Switch the BoneSTATION on using the power switch located on the right side of the unit 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 EDTA 10% or Formic acid 10%.

The above reagents must be onsite and available at time installation of unit.


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3. OPERATE WITH BONESTATION

Being an in -vitro medical device, used in labora tories where specimens and other biological tissues are handled, this system needs t o be cleaned and disinfected

before use. To assure operator’s safety gloves and eye protecti on are required when operating the

unit. The BoneSTATION unit 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 unit 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 the 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.

At the switch-on the BoneSTATION main screen appears.

The fixing disc must always be used, in order to av oid possible spilling out of cassettes from the rack during processing.

FIXING DISC


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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.

Both the front and back modules have particular accommodations to perfectly host the metal holders. See next figure for the accommodations.


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The two METAL HOLDERS have different labels: one for FIXATIVE and one for DECALCIFIER.

For good laboratory practice and to avoid any mistake, keep the beaker with fixative reagent in the FIXATIVE metallic holder and the beaker with decalcifier in the DECALCIFIER metallic holder.

3.2. Run Fixation and Decalcification programs

3.2.1. Fixation This phase is composed by:

1. PRESOAKING: carried out in the HOLDING POSITION and with fixative NOT heated but just agitated.

2. HEATED FIXATION: carried out in the HOT PLATE, with fixative heated and agitated. It is possible to skip the pre-soaking step if samples have already been fixed out of the BoneSTATION unit. Otherwise, if samples have not been fixed yet, include the pre-soaking step putting the FIXATIVE metal holder with glass containing fixative in the HOLDING POSITION (as shown in the picture).

Select “New Run” on the “Back Module” side on the touchscreen:


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In this screen user can modify:

• The Run ID of the process (RUN ID). • The reagent used in this phase (REAGENT). • Time duration of the PRE-SOAKING (TIME).

Click on the white fields “Run ID” and “Time” to modify them. A keyboard will appear, insert the Run ID and the time of the process (the hours in the left box and the minutes in right box), then press “Enter” to confirm.

Click on the drop-down menu to select the reagent from the list (see image below).

Then press “Start” to start the cycle. The pre-soaking phase is now running.


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On completion of the pre-soaking step, the heated fixation phase can be performed. Move the same FIXATIVE metal holder, with glass containing fixative, from the BACK MODULE to the FRONT MODULE.

On the Touch Screen, select “New Run” on the “Front Module” side to set up the Fixation Time and Temperature. Refer to the picture below.

In this screen, user can modify: • The Run ID of the process (RUN ID). • The Reagent used in this phase (REAGENT) • Time duration of the FIXATION (TIME) • Temperature during the FIXATION (TEMPERATURE). Each time a white box is clicked, a number pad appears; enter the number required and press “Enter”. Fill all the white boxes with data.


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Click on the drop-down menu to select the reagent from the list (see image below).

Click on the other fields to set the values: a keypad appears, set the values then press “Enter”.

Now press “Start” on the main screen to start the cycle.

FIXATION is now running. The software automatically warms up the solution to the desired temperature. It is possible to continuously monitor the real temperature of the solution in the field “TEMPERATURE”.

The processing time displayed by the system include s the heating time (necessary to warm up the solution to the selected temperature) p lus the time entered by the operator.


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During the heating time the system will show an orange box with the label “Warming up”. At the completion of this phase, the system will show a yellow box with the label “Time left”.

During all process of the “Front Module” the device will display a graph with a blue line that represents the preset temperature and a red line that represents the real temperature of the reagent. During each process it is possible to extend the duration of the process itself by clicking on the button

. The software will display a screen (see image below) where the user can set the minutes and the hours to extend the process.

While the extend screen is displayed, the system will automatically pause the process, until the operator clicks on “Continue”. If no extension time is entered, after 2 minutes, the system will continue with the process.


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If necessary, it is possible to press STOP to abort the program, and extract the rack with the cassettes

Confirm run cancelation by pressing “Abort front run”. The system will display that the run was succesfully aborted.

Then click “Confirm end” to return to the home screen.


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When one minute is left to complete the cycle an audio alarm warns the operator. On completion of the

process a different audio alarm sounds, the operator can silence both alarms pressing the icon on the main screen. At the end of the cycle press “Confirm End”.

The safety handles on the metal holders prevent possible burning.

Surfaces identified with this symbol are at a dange rous temperature (more than 70°C/158°F).

The warning light is ON when the temperature of the front plate is more than 70°C. This warning light works independently from the software, it remains ON also if the unit is OFF, disappearing only when temperature of the front plate decreases to a non-dangerous value.


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3.2.2. Decalcification At the end of fixation, it is recommended that tissue be thoroughly rinsed in running water prior to moving the rack with samples from the FIXATIVE metal holder, to DECALCIFIER metal holder, with glass containing decalcifier.

Put the DECALCIFIER metal holder, on the FRONT MODULE if heated decalcification is needed.

On the Touch Screen, select “NEW RUN” from the Front Module screen to set up the Decalcification Time and the Temperature. Follow the previous instructions (paragraph 3.2) on how to set the values for fixation.


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Now press “Start” to start the cycle.

While running a Heated decalcification protocol it is possible to start a new presoaking phase of other bone samples on the BACK MODULE. Simply put the FIXATIVE module on the Back Plate (see image below), then press “NEW RUN” from the screen of the Back Module (see the circle in the image above).

On completion of Decalcification an audio alarm sounds, the operator can silence it by pressing the icon

, then click “Confirm end” to confirm the end of the process.


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3.3. Run only a decalcification program If tissues have been previously fixed, it is possible to SKIP the fixation phase and proceed directly to the DECALCIFICATION phase. Put the DECALCIFIER metal holder, with glass containing decalcifier, on the FRONT MODULE if heated decalcification is needed. Then follow the instructions of chapter 3.2.2 on how to set program values and start a program. Put the DECALCIFIER metal holder, with glass containing decalcifier, on the BACK MODULE if NOT heated decalcification is needed. Then follow the instructions of chapter 3.2.2 on how to set program values and start a program.

3.4. Run only a fixation program If tissues need only to be fixed, it is possible to perform just a FIXATION phase. Put the FIXATIVE metal holder, with glass containing fixative, on the BACK MODULE no heating of fixation is needed (PRESOAKING). Then follow the instructions of chapter 3.2.1 on how to set program values and start a program. Put the FIXATIVE metal holder, with glass containing fixative, on the FRONT MODULE, if heated fixation is required. Then follow the instructions of chapter 3.2.1 on how to set program values and start a program.


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3.5. Working area

Place the instrument under a fume hood, in order to protect the operator and the environment from fumes generated by fixation and de calcification reagents loaded in

the glass vessels. The right side of the BoneSTATION is a working area on which are positioned two removable glass petri plates. The operator can use this area to place cassettes, pliers, needles, histomodule covers and racks in order to work more comfortably. Both glass petri plates are fully washable.


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4. REAGENT MANAGEMENT Replace the fixation and decalcification reagents following routine laboratory practices. The correct reagent management depends on the number of cassettes used in each run.

It is suggested to use the same fixative for 6 full racks. It is suggested to use the same decalcifier for 3 f ull racks.


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5. SETTINGS Clicking on the Settings Icon, the following screen appears:

In this section users can access the following areas:

A) Owner : Owner settings. B) Reagent list : add or remove reagents. C) Date/time : To set system date and time. D) Service : (only for SERVICE personnel, password is required).

5.1. Owner Select “Owner” from the “Settings” screen. The following screen appears as shown in the picture below.

Select this field to modify the name of the institute and the department where the unit is installed. User can also enable or disable the run ID by ticking the relative box.


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5.2. Reagent list From the “Settings” screen select “Reagent List” icon: the list of the preset reagents appears.

User can “Add” or “Delete” new reagents by clicking on icons on the right of the screen. Default reagents cannot be deleted.

Press the icon to go back to the “settings” and save any modification.

5.3. Date/time From the “Settings” screen select “Date/Time” (see figure below).

In the Time setting window it is possible to set the TIME ZONE, thus activating the automatic update of time during the year.

After changing the date/time please reboot the syst em (switch off, then then switch on).


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6. MAINTENANCE Minimal maintenance is required for laboratory personnel using a BoneSTATION in order to prevent the onset of more serious problems. The following procedure is recommended to ensure optimum performance of the unit.

6.1. Daily Make sure BoneSTATION is kept clean after each use. Do not use abrasive or sharp tools which can damage the coatings. Please follow the instruction below, to perform a correct cleaning procedure of the Bone Station.

It is recommended to use enzymatic detergents and polyphenolic based disinfectants or chlorine substitutes to clean the tool. In alternative the use of a solution of 1:10 bleach (recommended by the CDC for disinfecting) is also allowed to decontaminate the BoneSTATION. For further information, please contact the manufacturer: [email protected] Keep clean:

• BoneSTATION unit surfaces • Pyrex beakers • Metal holders • PTFE covers • Glass container • BoneSTATION racks

FOR CLEANING DO NOT USE PROCEDURES OTHER THAN THOSE EXPLAINED IN THIS MANUAL. Do not use direct or high-pressure water to clean t he instrument.


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7. GOOD LABORATORY PRACTICE FOR BONE DECALCIFICATIO N

7.1. Decalcification guidelines

EDTA 10%(pH 7.2-7.4) 37°C

EDTA10% (pH7.2-7.4) 50°C

FORMIC 10% 37°C

FORMIC 10% 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 recommends the checking of the bone samples during a decalcification program at half of the above time, so that users can better define optimum protocols for their samples. EDTA 10% (pH 7.2-7.4): recommended solution for optimal morphology, IHC and molecular biology. Heated 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 the checking of the bones’ status must be consistently performed. When users decide to set their own protocols, temperatures above 50°C should be avoided.

DECALCIFICATION GUIDELINES

PARTIALLY FIXED BONE MARROW

BIOPSY

FIXED BONE MARROW BIOPSY

FRESH BONE MARROW BIOPSY

Soaking in Formalin with agitation

30’: Small biopsy (1.8mm)

Heated Fixation complete phase 30’ 50°C: Small biopsy (1.8mm)

55’ 37°C: Small biopsy (1.8mm)

Heated decalcification


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7.2. Bone marrow 1.8mm DECALCIFICATION PROTOCOLS EDTA 10%

PHASE TEMPERATURE TIME PRESOAKING R/T 1 hour FIXATION 37°C 1 hour EDTA 10% 37°C 18 hours

TOTAL TIME: 20 hours

PHASE TEMPERATURE TIME PRESOAKING R/T 1 hour FIXATION 50°C 30 minutes EDTA 10% 50°C 4 hours

TOTAL TIME: 5 hours 30 minutes FORMIC 10%

PHASE TEMPERATURE TIME PRESOAKING R/T 1 hour FIXATION 37°C 1 hour FORMIC 10% 37°C 1 hour

30 minutes TOTAL TIME: 3 hours 30 minutes

PHASE TEMPERATURE TIME PRESOAKING R/T 1 hour FIXATION 50°C 30 minutes FORMIC 10% 50°C 1 hour

TOTAL TIME: 2 hours 30 minutes


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8. REPORTING

8.1. Display a process on the BoneSTATION It is possible to display a saved process directly on the BoneSTATION. Select “Log Book” from the main screen and then select “Autosaved Programs”.

Then select the date and the hour on which the process to display ended. Push the button “Open” and the system will display the graph of the selected process. A process executed on the front plate will be marked with the letter “F”, while a process executed on the back plate with the letter “B”.

Choose “Delete” or “Delete All” if you want to eliminate one file only or every file saved, respectively. Before deleting, we suggest to apply the step in next chapter.


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8.2. Export processing data from the terminal BoneSTATION 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 and the Events Log. Insert the USB memory stick into its slot placed on the right side of the instrument (figure below).

Select “Log Book” from the main screen and then select “Autosaved Programs”.

The following screen appears:

This allows you to export all the saved processed graphics: select the file of interest and press “Export” or “Export All” (arrow above) to copy the whole hard disk content.


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9. BONESTATION OPTIONAL ACCESSORIES Not included, to be ordered separately.

• Ref. P/N 67850 – Rack 16 megacassette for BoneSTATION

• Ref. P/N 67854 – Rack 30 cassette for BoneSTATION

• Ref. P/N 67855 – Rack 6 supermega cassette for BoneSTATION

• Ref. P/N 51413 – 5L tank MolDecal (Ready to use solution) • Ref. P/N 51412 – 1L bottle MolDecal (Ready to use solution)


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A. APPENDIX

A.1. How to manage an alarm

CODE DESCRIPTION WHAT TO DO

1 Communication fault 1. Press “Clear” to reset the alarm. 2. Reboot the system (wait 2 minutes before the

rebooting). 3. Contact your customer service if the issue cannot be

fixed or persists 11 Stirrer not running (Front

module) 1. Press “Clear” to reset the alarm. 2. Press “Silent” to hide the alarm. 3. Contact your customer service if the issue cannot be

fixed or persists. 12 Stirrer not running (Back

module) 1. Press “Clear” to reset the alarm. 2. Press “Silent” to hide the alarm. 3. Contact your customer service if the issue cannot be

fixed or persists. 21 Temperature too high 1. Press “Silent” to hide the alarm.

2. Check the presence and rotation of the stirrer. 3. Wait at least 10 minutes and then press “Clear” to

continue the program. 4. Contact your customer service if the issue cannot be

fixed or persists. 22 Temperature too low 1. Press “Silent” to hide the alarm.

2. Check the presence and the correct level of reagent inside the module. The reagent level must be above the MINIMUM marker in the module.

3. Verify if nothing is interposed between the infrared temperature sensor and the module.

4. Check the power line voltage of the laboratory and compare it with the voltage required by the instrument (see back label). Voltage must be the same (±10%) of that indicated on this label.

5. Contact your customer service if the issue cannot be fixed or persists.

Milestone Srl - via Fatebenefratelli 1/5 - 24010 Sorisole (BG) - ItalyPhone +39 035 4128264 - Fax +39 035 575498e-mail: [email protected] - web: www.milestonemedsrl.com

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