all new features · 2019-02-16 · uni en iso 9001: 2008 / uni en iso 13485:2004 certified •...

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www.milestonemed.com MILESTONE H E L P I N G P A T I E N T S FixSTATION 1RH Optimization, standardization and documentation of the fixation step All new features

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Page 1: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

www.milestonemed.com

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

FixSTATION 1RHOptimization, standardization and documentation of the fixation step

All newfeatures

Page 2: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

Accurate control of all steps of the preanalytical process is a prerequisite for precise, reliable and consistent diagnostic

assays. Recent publications1 have evidenced that standardization and documentation of the all important fixation

step will lead to improved I.H.C. assays.

Leaving the specimens in a plastic container with formalin overnight does not fulfill the requirements for controlled

fixation. No standardization, no documentation.

Small enought to fit any grossing station or ventilated hood, the FixSTATION 1RH is a game changer in controlling

the fixation process. Fixation of racks takes place in a close environment, outside the tissue processor, according to

specific protocols with full documentation readily available.

NEED GOOD RESULTS? START WITH GOOD PREPARATION

TODAY’S FIXATION

Until now, documented fixation protocols could only be obtained by placing specimens in an automatic tissue

processor. This means holding a high performance instrument almost idle for hours/days waiting for the fixation

process to be completed and documented.

1Consensus Recommendations on Estrogen Receptor Testing in Breast Cancer By Immunohistochemistry. Hadi Yaziji, MD et al.Applied Immunohistochemistry & Molecular Morphology - volume 16, Number 6, December 2008

2ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast CancerA. C. Wolff et al. Arch Pathol Lab Med - Vol. 131, January 2007/2013

THE GAME CHANGER. FixSTATION 1RH

CONTROL OF FIXATION

Fixation | FixSTATION 1RH

How many hours/minutes is overnight?

Is stirring available for temperature homogeneity?

What is the temperature of the fixative? Is the pH constant?

After how many cassettes is formalin substituted?

What kind of documentation is available?

Page 3: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

Formalin exit drain

USB port Touch screen terminal (4.3”)

Automatic stirring

Steel wire mesh fi lter

Protection cover

Formalin fi lling inlet

FixSTATION 1RH. AUTOMATIC TISSUE FIXATION SYSTEM

Suitable for racks of Milestone and racks from other manufacturers. Suitable for all kinds of fi xation reagents.Temperature range: up to 55 °C (131 °F).Time for pre-soaking: up to 99 hours 59 minutes.Time for fi xation: up to 99 hours 59 minutes.Stainless steel tank (AISI304) with 4.5L capacity.Steel wire mesh fi lter of fi xstation solution for protection againts contaminants.Automatic stirring of solution.Constant pH of solution during process (closed system).Full reagent management.

WHAT SETS US APART?

THE UNIQUE COMBINATION OF FULLY PROGRAMMABLE TIME/TEMPERATURE FIXATION PROTOCOLS COMBINED WITH REAGENT FILTERING FEATURES.

Fixation | FixSTATION 1RH

Full compliance to ASCO/CAP guideline recommendations

for HER2, ER testing2

Page 4: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

SIMPLICITY AT BEST. ICON DRIVEN SOFTWARE

Reagent management.Type of reagent. Life of reagent.

Store events log and saved program.

Defi ne setup of the unit according to your fi xa-tion requirements.

Enter your fi xation pro-tocol and press “Start”.

An audible alarm will sound when step is completed.

Fixation | FixSTATION 1RH

30 May 17

Reagents

Run ID

# Cassettes

Pre-soaking Time

Fixation Time

Hours

Hours

°C

Minutes

Minutes

Fix. Temperature

Run will end at

09:005302017

12:00, May 30-2017

Start

100

1

2

30

30

37

30 May 17

Reagents

08:50

30 May 17

Reagents

10:30Level 1

Service

ScreenSaver

Run IDPhase

Run will end at:

12:00, May 30-2017

Abort

Temperature (°C)

6070

5040302010

0 25min 50min 75min 100min 125min 150min 175min

5302017Fixation

Actual Temperature

37 °C

Reagents

Services

Log Book Settings

Help

30 May 17

Reagents

Run ID

# Cassettes

Pre-soaking Time

Fixation Time

Hours

Hours

°C

Minutes

Minutes

Fix. Temperature

Run will end at

09:005302017

12:00, May 30-2017

Start

100

1

2

30

30

37

30 May 17

Reagents

08:50

30 May 17

Reagents

10:30Level 1

Service

ScreenSaver

Run IDPhase

Run will end at:

12:00, May 30-2017

Abort

Temperature (°C)

6070

5040302010

0 25min 50min 75min 100min 125min 150min 175min

5302017Fixation

Actual Temperature

37 °C

Reagents

Services

Log Book Settings

Help

30 May 17

Reagents

Run ID

# Cassettes

Pre-soaking Time

Fixation Time

Hours

Hours

°C

Minutes

Minutes

Fix. Temperature

Run will end at

09:005302017

12:00, May 30-2017

Start

100

1

2

30

30

37

30 May 17

Reagents

08:50

30 May 17

Reagents

10:30Level 1

Service

ScreenSaver

Run IDPhase

Run will end at:

12:00, May 30-2017

Abort

Temperature (°C)

6070

5040302010

0 25min 50min 75min 100min 125min 150min 175min

5302017Fixation

Actual Temperature

37 °C

Reagents

Services

Log Book Settings

Help

Page 5: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

Rinse filter cage over a suitable sink to remove all tissue residues. This operation keeps the fixation solution free from all kind of matters (tissues, mucus) improving the processing step.

FLOATER AND CONTAMINANT CONTROL

EASY OPERATION

SAFE HANDLING

Place rack in the unit and enter fixation protocol.

1

Place rack in transfer tray.For safe handling a cover is placed on the tray.

4

6

Transfer the now clean rack to tissue processor.Skip processor fixation stepand process specimens in a shorter time.

5

After completion of run extract filtering cage from tank.The solution is filtered and residues are trapped in the steel wire mesh filter.

2 Eliminate excess reagent by placing filtering cage on the built-in front hinges.

3

Fixation | FixSTATION 1RH

UNIQUE FEATURE

Page 6: All new features · 2019-02-16 · UNI EN ISO 9001: 2008 / UNI EN ISO 13485:2004 CERTIFIED • CAT378EN-001 6475 Technology Avenue, Suite F Kalamazoo, MI 49009 - USA Tel: 269-488-4950

www.milestonemed.com UNI E

N ISO

9001

: 200

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485:2

004 C

ERTIF

IED • C

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MILESTONE MEDICAL TECHNOLOGIES, INC.6475 Technology Avenue, Suite FKalamazoo, MI 49009 - USATel: 269-488-4950 - Toll-free: 866-995-5300Fax: 269-488-4949email: [email protected]

US O� iceHeadquarters

MILESTONE SrlVia Fatebenefratelli, 1/524010 Sorisole (BG) - ItalyTel: +39 035 4128264Fax: +39 035 575498email: [email protected]

HIGH FLEXIBILITY

The FixSTATION 1RH will accept Milestone racks from

the PATHOS and LOGOS family as well as racks from the

most common conventional tissue processor of other

manufacturers.

Small enought to fi t any

grossing station or ventilated

hood. Dimensions shown are

during operation of the unit.

MANUAL

With the FixSTATION 1RH, documentation of every factor infl uencing the fi xation process is stored in a log book

for easy retrieval. Fixation protocols can be transferred to a USB stick and then printed for Quality Assurance and

Compliance regulations. Full compliance to ASCO/CAP recommendations for HER2, ER testing2.

FULL DOCUMENTATION

Type of fi xative

Pre-soaking timeTemperature of fi xative

Time and date of fi xation run

Event logLength of fi xation time

Saved runs

MANUAL

LIMITED FOOTPRINT

SUITABLE FOR ALL TYPE OF RACKS

26 cm (10,2”)26 cm (10,2”)

52 cm(20,4”)

30 cm(11,8”)

26 cm (10,2”)26 cm (10,2”)

24 cm(9,4”)

52 cm(20,4”)