Sakura Tissue-Tek Xpress x120 Operating Manual

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Page 1

Operating

Manual

Tissue-Tek

Rapid Tissue Processor

Xpress® x120

Operating

Manual

Page 2

Operating

Manual

Tissue-Tek

Rapid Tissue Processor

Xpress

x120

Operating

Manual

Page 3

Page 4

0004389-03 Rev.C

Manufactured for:

Printed in U.S.A.

Sakura Finetek U.S.A., Inc. Torrance, CA 90501 U.S.A.

Page 5

TABLE OF CONTENTS

Section Page

1 INTRODUCTION

Intended Use ................................................................................................................................................ 1.1

General Description ...................................................................................................................................... 1.1

Safety Precautions ....................................................................................................................................... 1.2

Location of Major Systems and Components ............................................................................................... 1.6

Specifications ............................................................................................................................................. 1.12

Safety Standards ........................................................................................................................................ 1.13

2 INSTALLATION

Turning Instrument Power On or OFF .......................................................................................................... 2.1

General Information ...................................................................................................................................... 2.1

Environmental Factors .................................................................................................................................. 2.1

Set Reagent Bottle ....................................................................................................................................... 2.2

Pre-Start Checks .......................................................................................................................................... 2.2

Unpacking and Installation............................................................................................................................ 2.3

3 CUSTOMIZATION OF SETTINGS

General Information ...................................................................................................................................... 3.1

Accessing the UTILITIES Menu .................................................................................................................... 3.1

Configuring System Settings ........................................................................................................................ 3.2

4 OPERATING INSTRUCTIONS

Initial Setup ................................................................................................................................................... 4.1

Understanding the Control Panel Display ..................................................................................................... 4.1

Preparation for Processing ........................................................................................................................... 4.2

System Start Up ........................................................................................................................................... 4.3

System Operation ......................................................................................................................................... 4.5

Special Conditions and Considerations ...................................................................................................... 4.12

Viewing Reports and Statistics ................................................................................................................... 4.13

5 RECOVERY PROCESS

Overview ....................................................................................................................................................... 5.1

Detecting an Error Condition ........................................................................................................................ 5.1

Starting a Processing Run in Retort 3 or 4 ................................................................................................... 5.2

6 CONSUMABLES AND ACCESSORIES

Consumable Materials .................................................................................................................................. 6.1

Standard Accessory Items ............................................................................................................................ 6.1

Maintenance and Service Items ................................................................................................................... 6.2

Accessory Items for Compatibility with the Tissue-Tek

AutoTEC

Embedding System ........................................ 6.2

Revised 10/02/2012 iii

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TABLE OF CONTENTS

Section Page

7 CARE OF THE INSTRUMENT

General Information ...................................................................................................................................... 7.1

On Condition Maintenance ........................................................................................................................... 7.1

Daily Maintenance ........................................................................................................................................ 7.7

Weekly Maintenance .................................................................................................................................... 7.8

Monthly Maintenance.................................................................................................................................. 7.11

Routine Maintenance Check List ................................................................................................................ 7.13

8 TROUBLESHOOTING

General Troubleshooting Procedures ........................................................................................................... 8.1

Monitored Errors ........................................................................................................................................... 8.2

9 SERVICE AND REPLACEMENT PARTS

Service Information ....................................................................................................................................... 9.1

Consumable Materials .................................................................................................................................. 9.1

Replacement Accessory Items ..................................................................................................................... 9.1

Service Accessory Items .............................................................................................................................. 9.1

Optional Accessory Items ............................................................................................................................. 9.2

APPENDIX Tissue-Tek

Overview ....................................................................................................................................................... A.1

Preparation for Processing ........................................................................................................................... A.1

Use of Tissue-Tek Xpress x120 Pre-Processing Solution or Pre-Processing Fixative ................................. A.1

Use of Tissue-Tek Molecular Fixative ........................................................................................................... A.2

Embedding of Tissue-Tek Xpress x120 Processed Tissue .......................................................................... A.4

Microtomy ..................................................................................................................................................... A.4

Staining ......................................................................................................................................................... A.4

Microscopic Evaluation ................................................................................................................................. A.5

Reprocessing of Tissue ................................................................................................................................ A.5

Tissue-Tek Xpress x120 Reagent Replacement Schedule ......................................................................... A.5

Do’s and Don’ts ............................................................................................................................................ A.6

Disposal of Tissue-Tek Xpress x120 Processing Solutions .......................................................................... A.6

Tissue-Tek Xpress x120 Processing Flow Chart for Standard Program....................................................... A.7

Tissue-Tek Xpress x120 Processing Flow Chart for Extended Program ...................................................... A.7

Xpress® x120 Rapid Tissue Processor Applications Manual

iv Revised 10/02/2012

Page 7

INTRODUCTION

Section 1

Intended Use

The Tissue-Tek® Xpress® x120 is designed for the purpose of processing human and animal tissue specimens.

The instrument, as part of the histopathology process, is intended to facilitate the in vitro examination of human and animal tissue for morphology changes by a pathologist.

General Description

The Tissue-Tek® Xpress® x120 Continuous Rapid Tissue Processor is a self-contained tissue processor employing microwave and vacuum infiltration techniques. The instrument performs automatic rapid processing (fixation, dehydration, clearing, and paraffin impregnation) of tissue specimens in preparation for histological study and examination. The instrument incorporates individual processing stations, scheduling software, and an automated transfer system that provides for continuous processing of multiple sample baskets. Processing time for a single basket is approximately 65 minutes, with a maximum throughput (during continuous processing) of 120 specimens per hour.

NOTE: Maximum throughput is based on processing 40 cassettes per basket, where processing time for all processes is equal (15 minutes). Reduction in the number of cassettes processed per basket, or an increase in processing time will lower throughput.

In order to achieve continuous processing, the instrument utilizes a Transfer System that sequentially moves baskets containing tissue specimens from a Loading Station, through the four processing retorts to an Unloading Station for removal of the basket. The instrument employs scheduling software to efficiently process and transfer sample baskets.

The Tissue-Tek Xpress x120 instrument has the following features:

• Instrument can be configured for either Manual or

Automatic start-up

• Compatible specimen types include Formalin fixed

tissue, tissue fixed in Tissue-Tek Xpress Molecular Fixative

• Supports use of standard cassettes and Tissue-Tek

Paraform

cassettes (both microwavable); compatible

cassettes include:

Standard cassette (Tissue-Tek

Brand Uni-Cassette

Cassettes)

Biopsy cassette (Tissue-Tek

Brand Uni-Cassette

Biopsy Cassettes)

Tissue-Tek

Brand Paraform® Standard cassette

Brand Paraform® Biopsy cassette

Brand Paraform® Biopsy 13 x13 cassette

Brand Paraform® Biopsy Core cassette

Brand Paraform® Biopsy Shaved cas-

sette

Tissue-Tek

Brand Paraform® Orientation cassette

• Standard cylindrical basket with lid facilitates

processing of up to 40 cassettes per basket; upper loading limit of basket is marked to aid in positioning cassettes

• Tissue-Tek

Paraform® magazines are compatible for

use with the instrument (for use in conjunction with

the Tissue-Tek

)

System

. Each Tissue-Tek Paraform magazine holds

up to 20 Paraform

AutoTEC® Automated Embedding

cassettes. Two magazines linked by a handle can be placed in the Loading Station of the Tissue-Tek Xpress x120.

• Two user-selectable automated processing programs

based on specimen thickness, Standard Program (15 minutes per retort) or Extended Program (30 minutes per retort).

• Maximum throughput of 120 cassettes per hour

(under Standard Program, where each basket or pair of magazines processed contains 40 cassettes)

• Integral fume control system to prevent fumes from

escaping the instrument

Revised 10/02/2012 1.1

Page 8

INTRODUCTION

Safety Precautions

NOTES, CAUTIONS, WARNINGS, and other safety related labeling are provided throughout this manual to indicate levels of potential hazards as defined below:

NOTE Indicates a reminder or other helpful

information.

CAUTION Indicates a potential hazard in which

failure to follow instruction may result in damage to the Tissue-Tek x120 and/or other property, or may give poor processing results.

WARNING Identifies a potential hazard in which

failure to follow instructions may result in serious injury to the operator and/or other personnel.

Xpress®

HOT SURFACE Indicates hot surfaces. Take precautions

to prevent burns.

BIOHAZARD Possibility of infections depending on

the type of specimens processed. Prevent infections by using Personal Protective Equipment (PPE) as required by OSHA and any applicable state or local regulations.

CAUTION: Do not use cassettes that contain metal or use metal lids. Do not place any metal items in Retorts #1 and #2.

CAUTION: When placing cassettes into the basket, do not allow cassettes to extend above the upper limit band.

CAUTION: The instrument uses flammable liquids. Do not use an open flame near the instrument.

CAUTION: When operating the instrument or when handling contaminated, bio-hazardous materials use Personal Protective Equipment (PPE) as required by OSHA and any applicable state or local regulations.

CAUTION: Operating the instrument for a use other than described in the operating manual could result in hazardous conditions.

CAUTION: Do not remove the Outer Panels on the instrument.

1.2 Revised 10/02/2012

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Cabinet Front (Figure 1-A)

Loading Station Access Door

the Loading Station to allow loading of tissue specimens for processing. Access to the Loading Station is permitted/ denied, under software control, depending on the current state of the instrument (see “Loading Indicator”, below, for details). A switch associated with the access door serves as an interlock to immediately remove power from the Transfer System motors (see “Transfer System (Figure 1-M)” on page 1.11 for details) in the event the door is opened while a transfer is in process. An alarm sounds any time the Loading Station access door is open, even though the Loading Indicator is off. An alarm also sounds if the Loading Station access door is left open for 30 seconds or more while the Loading Indicator is illuminated.

Loading Indicator ..

status of the Loading Station access door:

Light Off – indicates “access denied” to the Loading Station access door; the door should not be opened. The Loading Indicator is “off” whenever there is a basket in the Loading Station or when the Transferring Arm is in motion.

— provides an indication of the

..1

.. — provides access to

Light On – indicates “access permitted” to the Loading Station access door; the door can be opened. The Loading Indicator is “on” when there is no basket in the Loading Station and the Transferring Arm is stationary.

The Loading Indicator is operational only when a user is logged onto the system.

Unloading Station Access Door ..

to the Unloading Station to allow unloading of processed tissue specimens. Access to the Unloading Station is permitted/denied, under software control, depending on the current state of the instrument (see “Unloading Indicator” on page 1.4 for details). A switch associated with the access door serves as an interlock to immediately remove power from the Transfer System motors (see Figure 1-M on page 1.11 for details) in the event the door is opened while a transfer is in process. An alarm sounds any time the Unloading Station access door is open, even though the Unloading Indicator is off. An alarm also sounds if the Unloading Station access door is left open for 30 seconds or more while the Unloading Indicator is illuminated.

— provides access

Revised 10/02/2012 1.3

Figure 1-A

Page 10

INTRODUCTION

Unloading Indicator

status of the Unloading Station access door:

Light Off – indicates “access denied” to the Unloading Station access door; the door should not be opened. The Unloading Indicator is “off” whenever the Unloading Station is empty or when the Transferring Arm is in motion.

Light On – indicates “access permitted” to the Unloading Station access door; the door can be opened. The Unloading Indicator is “on” when there is a basket in the Unloading Station and the Transferring Arm is stationary.

Flashing – alerts the operator to remove the basket(s) from the unloading station or the access door is open and needs to be closed immediately.

Audible Alarm (not shown) – indicates the following:

• A tone sounds at the completion of a processing cycle

(when a basket has arrived at the Unloading Station). Tone selection (from seven available tones), volume selection (high, middle, low), and pattern selection (continuous, intermittent, 30 seconds only) are user selectable (see “Configuring System Settings” on page

3.2 for details).

• A continuous tone sounds if an abnormal condition is

detected during processing. The alarm condition must be acknowledged and/or cleared by the operator to cancel the alarm. Tone selection (from seven available tones) and volume selection (high, mid, low) are user selectable (see “Configuring System Settings” on page 3.2 for details).

Retort Access Door

Microwave and Vacuum Stations for purposes of cleaning and/or maintenance. Access to all four retorts is permitted/denied, under software control, when the instrument is processing specimens.

Retort #1 / #2 Reagent Cabinet Access Door

provides access to retort #1 / #2 Reagent Cabinet for the purposes of replacing reagents.

Retort #3 / #4 Reagent Cabinet Access Door

provides access to the paraffin oven for the purposes of replacing reagents.

Control Panel

indicators necessary to program and operate the instrument, and to monitor the instrument during processing (refer to “Control Panel (Figure 1-O)” on page 1.12 for details).

..4.

. — provides an indication of the

..5

.. — provides access to the

..6

..7

..8

.. — comprises the controls and

.. —

Fume Control System Access Door

access to the fume control system for purposes of replacing the fume filter.

Overflow Bottle Access Door

to retorts #3 / #4 overflow bottles for purposes of cleaning and servicing.

Leveling Feet/Casters

to allow for easy repositioning of the instrument. Adjustable leveling feet associated with each caster facilitate proper leveling of the instrument.

..11

..10

.. — four casters are provided

..9

.. — provides

.. — provides access

Cabinet Rear (Figure 1-B)

The power cord connector and external interface are

located at the rear of the back cabinet.

Figure 1-B

Power Cord Connector

end of the power cord; opposite end of the power cord may be connected to facility power.

..12

.. — accepts the instrument

1.4 Revised 10/02/2012

Page 11

Figure 1-C

Power Switch

the cabinet (Figure 1-C), turns the power on and off.

System Start Button

side panel above the power switch, (Figure 1-C) turns on the computer system.

Internal Light Button

Tissue-Tek Xpress x120 on or off (Figure 1-D). The light must be manually turned off. Shutting down the instrument will not turn the light off.

USB Interface

connection to a memory stick for transfer of data to an external PC (Figure 1-D).

..13

.. — Located on the right side panel of

..14

.. —A button located on the right

..15

.. — Turns the light inside the

..16

. — USB communication port for

Figure 1-D

External Alarm Output Port — allows for connection of

an external audible alarm to a switched no-voltage contact within the Tissue-Tek Xpress x120; contact is switched when an alarm condition occurs.

UPS Signal Input Port — provides for connection of the Tissue-Tek Xpress x120 to an external Uninterruptible Power Supply (UPS) or backup generator.

Revised 10/02/2012 1.5

Page 12

INTRODUCTION

Location of Major Systems and Components

The Tissue-Tek Xpress x120 instrument is comprised of the following major systems and components (Figure 1-E):

..18

..19

..20

..21

..8

..17

• Control Panel

• Loading Station

• Retort #1

• Retort #2

• Retort #3

• Retort #4

..26

..22

..23

..25

..27

..24

..28

• Unloading Station

• Transfer System

• Fume Control System

• Reagent Cabinet

• Paraffin Oven

• Overflow Bottles

• Accessory Compartment

Major systems and components of the Tissue-Tek Xpress x120 instrument are described in the following paragraphs.

1.6 Revised 10/02/2012

Figure 1-E

Page 13

Loading Station (Figure 1-F)

Figure 1-F

The Loading Station (Figure 1-F) is an unheated, reagent-filled, removable stainless steel container facilitates the loading of a single basket or two Paraform magazines, containing a maximum of 40 tissue cassettes, into the Tissue-Tek Xpress x120. The Loading Station retort holds a maximum of approximately 1.8 liters of reagent (Preprocessing Solution, product code 7115).

Access to the Loading Station is facilitated by an access door in the Cabinet Front (see “Cabinet Front (Figure 1-A)” on page 1.3 for details).

A removable lid protects the retort contents (reagent) when the instrument is not in operation.

Microwave Stations (Retorts #1 and #2)

NOTE: Retort #1 and Retort #2 are identical.

At these Mircrowave Stations (Retorts #1 and #2)

..18

( processes are performed. The reagent in the Microwave Station retorts is heated by radiating microwaves. Each Microwave Station is comprised essentially of a microwave retort and associated microwave unit (microwave applicator and power supply), preheating chamber, reagent container, and reagent cabinet.

..19

..,

.., Figure 1-G) dehydration and clearing

..17

.. that

Microwave Retorts (Figure 1-G)

Figure 1-G

Each microwave retort supports the processing of a single basket or two Paraform magazines containing a maximum of 40 cassettes. Each microwave retort has a designated reagent supply level of approximately 1.44 liters, with a maximum capacity of approximately 1.74 liters. Filing and draining of the retorts is accomplished by a reagent flow circuit operating under software control. The flow control circuit incorporates an interlock that prevents reagent from draining out of the retort if a reagent container is not in place in the reagent cabinet.

A two-level reagent level detector is provided. The lower level is used to stop supplying reagent when replenishing; the upper level is used to prevent reagent overflow. When the upper level sensor is actuated, an audible alarm sounds, and the line pump is stopped.

A software controlled temperature regulation unit allows control of reagent temperature at 51°C. The set temperature for the microwave retorts is established during installation, according to elevation of the installation site. A bubbling pump is employed to supply volatilized reagent to the microwave retort to aid in equalizing the temperature of the reagent within the retort.

A hinged lid protects the retort contents during processing. The lid is opened automatically during transfer operations, and may be opened manually when no power is applied to the motor to allow for cleaning and maintenance of the retort. Each retort lid has a sensor that prevents the associated microwave unit from being energized in the event the lid is not fully closed, and immediately turn off the magnetron in the event the lid is opened during processing.

Revised 10/02/2012 1.7

Page 14

INTRODUCTION

Preheating Chambers

Preheating chambers are used to temporarily store reagent when draining Retorts #1 and #2 prior to transferring a basket or magazines. The Preheating Chambers are located between the retorts and the reagent containers, and keep the reagents warm during basket/magazine transfers. No user access is required except when cleaning the Preheating Chamber sight tubes (see “Preheating Chamber Sight Tube” on page 7.11). Each preheating chamber has a maximum capacity of approximately 2.4 liters.

A three-sensor level detection circuit is provided for reagent level detection.

• The lower-level detector is used to stop supplying

reagent (after supplying approximately 0.6 to 0.8 liter) when replenishing reagent in Retorts #1 and #2. The sensor is also used to detect low reagent volume level for reagent replenishing.

• The mid-level sensor is used to prevent overflow from

the preheating chamber during reagent transfer from the retort to the preheating chamber. When the midlevel sensor is actuated, reagent is drained from the retort to the reagent container rather than being transferred to the preheating chamber.

• The upper sensor is used to prevent reagent

overflow. The sensor is actuated at approximately 2.5 liters. When the upper sensor is actuated, an audible alarm sounds, and the line pump is stopped.

A software-controlled temperature regulation unit maintains temperature in the preheating chamber.

Reagent Cabinet (Figure 1-H)

Figure 1-H

The reagent cabinet in the cabinet front (see “Cabinet Front (Figure 1-A)” on page 1.3 for details). The reagent cabinet provides storage space for the reagent containers used by Retorts #1 and #2. A two-position locking lever with each Retort couples the associated reagent container with the reagent flow circuit, and secures the container in place in the cabinet. The reagent cabinet also interfaces with the Tissue-Tek Xpress x120 fume control system (see “Fume Control System” on page 1.11 for details).

The reagent containers that hold the processing reagents for Retorts #1 and #2. Each reagent container is equipped with a two-piece cap/connector shipment and storage of the container. The lower cap facilitates connection of the container to the Tissue-Tek Xpress x120 system. The same reagent is used in Retorts #1 and #2. The caps and labels are color-coded blue so that the containers cannot be mistaken for other reagents.

.25c

..25

.. is accessed through a door

.25a

. associated

.25b

. are disposable containers

.. The upper cap is used during

1.8 Revised 10/02/2012

Page 15

Vacuum Stations (Retorts #3 and #4)

NOTE: Retort #3 and Retort #4 are identical.

These Vacuum Stations (Retorts #3 and #4) (..20..,

..21.., Figure 1-I) are where the paraffin impregnation

processes are performed. The vacuum in the vacuum retort increases removal of the Microwave Station reagents from the tissue specimens, and improves paraffin impregnation of the specimens. Each Vacuum Station is comprised essentially of a vacuum retort with integral retort heater, vacuum pump, paraffin oven, and overflow bottles.

Vacuum Retorts (Figure 1-I)

Vacuum pumps are used to pump reagent (melted paraffin) into the Vacuum Station retorts. The vacuum pump for Vacuum Retorts applies vacuum for 80 seconds, and then is off for 10 seconds (no vacuum applied). This cycle is repeated continuously.

Reagent is drained from the Vacuum Station retorts to the paraffin oven by gravity. Drain time is approximately five minutes.

Paraffin Oven (Figure 1-J)

Figure 1-I

Each vacuum retort supports the processing of a single basket or two Paraform magazines containing a maximum of 40 cassettes. Each vacuum retort has a maximum reagent capacity of approximately 2.0 liters. Filling of the retorts is accomplished by a vacuum pump and reagent flow circuit operating under software control. An ultrasonic sensor is provided for reagent level detection. The sensor is used to stop supplying reagent (at approximately 1.7 liters), when replenishing. The retorts utilize gravity to drain reagent to the paraffin oven.

A software-controlled temperature regulation allows control of reagent temperature at 65°C. An over temperature control (thermal fuse) prevents overheating of the reagent.

Figure 1-J

The paraffin oven

the cabinet front (see “Cabinet Front (Figure 1-A)” on page

1.3 for details). The paraffin oven is a two-compartment, drawer-mounted container that provides for the storage and heating (melting) of the Vacuum Station reagents. The oven has the capability to melt paraffin at a rate of 2.4 kg (3.0 liters) within 4 hours. Temperature of the paraffin oven is controlled at the set temperature of Vacuum Stations Retorts #3 and #4 by a software-controlled temperature regulation unit. An over temperature control (thermal fuse) prevents overheating of the reagent.

The oven incorporates separate compartments for Vacuum Station Retort #3 and Vacuum Station Retort #4 reagents. Each compartment has a capacity of approximately 3.0 liters of paraffin chips. A reagent level mark in each compartment indicates the proper reagent level inside the compartment (approximately 3.0 liters).

..26

.. is accessed through a door in

Revised 10/02/2012 1.9

Page 16

INTRODUCTION

Figure 1-J

The oven compartments are not removable, but slide in and out of the Tissue-Tek Xpress x120 cabinet for purposes of filling, draining, and maintenance. A spigot facilitates the draining of the reagents (see “Retort #3 and #4 Paraffin Replacement” on page 7.5). Each compartment is covered by a protective hinged lid

..26b

pan prevent drips of melted paraffin from falling to the floor around the unit that may occur during the filling or maintenance of the oven.

.. is provided at the front of the paraffin oven to

..26a

... A drip

overflow bottles are accessed through a door in the cabinet front (see “Cabinet Front (Figure 1-A)” on page 1.3 for details).

Unloading Station (Figure 1-L)

The Unloading Station provides for storage of baskets or magazine sets after completing tissue processing. Access to the Unloading Station is facilitated by an access door in the Cabinet Front (see “Cabinet Front (Figure 1-A)” on page 1.3 for details). The Unloading Station is comprised essentially of a dual-retort, heater, and transport tray.

Figure 1-L

Overflow Bottles (Figure 1-K)

Figure 1-K

An overflow bottle Retort serves as an overflow receptacle in the event excess reagent (paraffin) is pumped into the associated retort. Each bottle has a capacity of 250 milliliters. A proximity sensor bottle) is provided for reagent level detection. The

..27

.. associated with each Vacuum

..27a

.. (located behind each overflow

The dual-retort two processed baskets or four Paraform magazines containing a maximum of 80 tissue cassettes. The retort is removable for ease in cleaning. A software-controlled temperature regulation unit maintains the paraffin in the processed specimens in a molten state prior to transport and paraffin imbedding.

The heater allows control of retort temperature at 65°C. An over temperature control prevents overheating.

A hinged lid protects the contents of the retorts during storage. The lid is opened automatically during transfer operations, and may be opened manually when no power is applied to the motor to allow for cleaning and maintenance of the retort.

A transport tray is provided to prevent paraffin dripping when removing and manually transporting baskets from the Tissue-Tek Xpress x120 to a paraffin embedding center. The transport tray facilitates transport of two baskets or four Paraform magazines simultaneously.

..22

.. allows for temporary storage of

1.10 Revised 10/02/2012

Page 17

Transfer System (Figure 1-M)

The Transfer System performs the automated process of transferring baskets from the Loading Station to the Microwave and Vacuum Stations, and ultimately to the Unloading Station. The Transfer System is comprised of a motor-driven transfer arm ment in the X (horizontal) and Z (vertical) axes.

When the instrument is not processing specimens, the transfer arm can be moved manually.

A drip pan prevents reagent from dripping onto the top panel in the instrument when a basket is transferred between stations. A disposal tray liner rotational drive associated with the drip pan automatically retracts the drip pan to allow the transfer arm to raise or lower a basket. The drip pan is returned to its location beneath the basket while traveling horizontally between stations.

..23a

..23

.. that provides for move-

Figure 1-M

.. associated with the transfer arm

..23b

.. receives reagent drips. A

Fume Control System (Figure 1-N)

Figure 1-N

The Fume Control System ..

ly of a hood, activated carbon absorption filter, and exhaust fan. The Fume Control System is accessed through a door in the cabinet front (see “Cabinet Front (Figure 1-A)” on page 1.3 for details).

The Fume Control System hood serves to prevent hazardous fumes from leaking to the outside of the instrument. The system collects reagent fumes from inside the instrument and passes them through an activated carbon absorption filter to reduce fume emissions to acceptable levels. The filtered air is then discharged to the atmosphere. The fume control exhaust fan is active whenever power is applied to the instrument. In the event the fume control exhaust fan fails while the instrument is in operation (processing is being performed), an audible alarm sounds.

Additionally, a duct is provided on the instrument rear panel to facilitate connection of the Fume Control System to a facility exhaust system.

is comprised essential-

Revised 10/02/2012 1.11

Page 18

INTRODUCTION

Continuous Rapid

Control Panel (Figure 1-O)

The Control Panel and indicators necessary to operate the instrument, monitor system operation, configure system settings, and view status and historical reports.

Main Power Indicator ..

applied to the instrument.

System Status Indicator ..

of the current status of the system. Flashes when the WARMING UP SYSTEM mode is in process. Lights steady on when the system is ready for processing.

Auto Start / Shutdown Indicator ..

Auto Start/Shutdown function is activated (see “Section 3, Setting Ready/Shutdown Times” on page 3.7).

LCD Display ..

display. The instrument sounds a tone whenever a key, button or text field is actuated (with the exception of the 10-key keypad and alpha keyboard). When in processing mode, provides the data entry and display screens to login to the system, prepare a basket for processing, and monitor processing status (see “Section 4, Operating Instructions” for details). When in utility mode, provides the data entry and display screens to manage instrument users, configure system settings, and view statistical data (see “Section 3, Customization of Settings” and “Section 4, Operating Instructions” for details).

1.12 Revised 10/02/2012

..8

.. provides the operating controls

Figure 1-O

— lights when main power is

— provides an indication

— 800 X 600 pixel touch screen LCD

— indicates the

Specifications

Models Covered By This Manual:

Product

Code

7720 Tissue-Tek

Tissue Processor (200 VAC) (USA)

7721 Tissue-Tek

Tissue Processor (200 VAC) (Asia)

7722 Tissue-Tek

Tissue Processor (230 VAC) (Europe)

Name/Description

Xpress® x120 Continuous Rapid

Xpress® x120

Xpress® x120 Continuous Rapid

Power Requirements:

Model 7720 – 200VAC ±10%, 50/60Hz, single-phase, 20 amps

Model 7721 – 200VAC ±10%, 50/60Hz, single-phase, 20 amps

Model 7722 – 230VAC ±10%, 50/60Hz, single-phase, 20 amps

Power Ratings:

Model 7720 – 200VAC, 50/60Hz, single-phase, 15 amps

Model 7721 – 200VAC, 50/60Hz, single-phase, 15 amps

Model 7722 – 230VAC, 50/60Hz, single-phase, 13 amps

Noise Level: Less than 65 db

Hazardous Fume Control

Complies with the following requirements for acetone as fume emissions in laboratories:

1,000 ppm, Occupational Safety and Health Administration (USA); 750 ppm, Industrial Safety and Health Law (Japan); 500 ppm, Maximale ArbeitsplatzKonzentration (Europe)

Environmental Requirements:

Operating:

Temperature Range: +15°C to +35°C

Relative Humidity: 30% to 85%, non-condensing

Relative Atmospheric Pressure: 70 to 106 kPa (525 to 795 mm Hg)

Pollution Degree: 2

Page 19

Storage:

Temperature Range:-10°C to +65°C

Relative Humidity: 30% to 95%, non-condensing

Relative Atmospheric Pressure: 70 to 106 kPa (525 to 795 mmHg)

Dimensions:

Height: 162 cm (63.8 in.)

Width: 170 cm (66.9 in.)

Depth: 70 cm (27.6 in.)

Weight: 465 kg (1023 lbs)

Instrument Life Expectancy: 7 years (with

instrument powered on 24 hours a day, every day)

Safety Standards

Electrical Safety:

For Model 7720 –

cETL Certification

Complies with:

UL 61010-1: 2

CAN/CSA-C22.2 No. 61010-1: 2

CAN/CSA-C22.2 No. 61010-2-010:04, IEC61010-2-010: 2003

CAN/CSA-C22.2 No. 61010-2-081:04, IEC61010-2-081: 2001

CAN/CSA-C22.2 No. 61010-2-101: 04, IEC61010-2-101: 2002

FDA Registration (Regulation No. 864.3875)

Ed.: 2004,

For Model 7721 –

Japanese Pharmaceutical Law

Complies with:

Quality Management System- ISO 13485: 2003

Electrical Safety

JIS C 1010-1: 2005

IEC61010: 2001 (ed2)

IEC61010-2: 010: 2003

IEC61010-2-081: 2001

IEC61010-2-101: 2002

EMC- JIS C1806-1: 2001

Risk Management- JIS T 14971: 2003

For Model 7722 –

Complies with:

LVD, IVD

EN61010-1: 2001 (ed2)

EN61010-2-010: 2003 (ed2)

EN61010-2-081: 2001

EN61010-2-101: 2002

EMC

CISPR11: 1999 Group 1 Class A (EN55011)

EN50082-1: 1997

EN61000-3-3: 1994 Amendment 1&2 (2001)

EN61000-4-2: 1995 Amendment 1&2 (2001)

EN61000-4-3: 2002

EN61000-4-4: 2004

EN61000-4-5: 1995 Amendment 1

EN61000-4-6: 1996 Amendement1&2&3&correction1

EN61000-4-11: 2004

Revised 10/02/2012 1.13

Regulatory Information:

FDA Certified with ETL evaluation (USA); complies with requirements of The Pharmaceutical Affaires Law (Japan); CE Certified in compliance with the requirements of EMC Directive, LV Directive in Europe (Europe)

Page 20

INTRODUCTION

1.14 Revised 10/02/2012

Page 21

INSTALLATION

Section 2

Turning Instrument Power On or Off

The main power to the entire instrument is turned on

and off by the power switch .1. (Figure 2-A), located on the right side panel. In the up position the switch turns the power on and in the down position the switch turns the power off.

Figure 2-A

Turning the Power Off (for extended nonuse)

The Tissue-Tek® Xpress® x120 instrument has been designed to run continuously. However, if it ever becomes necessary to turn the unit off for extended periods (weeks or months), it is recommended that all reagents be drained from the instrument and the instrument processing chamber be thoroughly cleaned and disinfected. The loading station, unloading station, and retort access doors should then be left open until the interior of the instrument is completely dry. Once dry, close the access doors to keep the interior free of dust and debris.

General Information

This section provides information on determining a location for, and installing, the Tissue-Tek instrument. Installation should be performed by a qualified instrument service technician only. The Tissue-Tek Xpress x120 instrument must be installed correctly to ensure proper operation and service.

Read this operating manual carefully before attempting to operate the Tissue-Tek Xpress x120 instrument. Follow all instructions carefully.

CAUTION: The Tissue-Tek Xpress x120 is a precision instrument and must be handled accordingly. Rough handling or dropping will disturb or damage internal components. Always handle the instrument with care.

Xpress® x120

Environmental Factors

As with all sensitive electronic equipment, avoid prolonged exposure to excessive temperature and humidity. Temperature and humidity should be held relatively constant to obtain the highest degree of operating stability. The ambient operating temperature range of the instrument is 15° to 35°C (59° to 95°F). The ambient operating humidity range is 30% to 85% relative humidity, noncondensing.

Locate the instrument in a well-ventilated area, avoid- ing exposure to corrosive vapors, direct air currents, or temperature extremes. Avoid proximity to direct sunlight, open windows, sinks, ovens, open flames, hot plates, radiators, and dry ice baths. Locate the instrument away from any equipment that consumes a high voltage or large current, including large refrigerators and ovens. Since the instrument is very heavy, the floor must be solid and level.

Be sure the instrument is located near a power source that meets the electrical requirements (voltage and amperage) specified on the rating label located on the rear of the instrument. The power receptacle must be grounded and should be a clean, noise-free, dedicated line.

Ensure that the selected installation site provides sufficient clearance to allow for proper operation if the instrument, and to provide adequate ventilation for the condenser, vacuum pump, microwave units, fans, and pumps.

Revised 10/02/2012 2.1

Page 22

INSTALLATION

Set Reagent Bottle

1. Place the new reagent container in the reagent cabinet

in the appropriate position.

2. Press down on the reagent container locking lever until

it engages the “LOCKED” position, coupling the reagent container with the reagent supply system (Figure 2-B).

Figure 2-B

• Verify both reagent containers are full. Ensure

both reagent containers are in their proper positions in the cabinet, and that locking levers for both containers are in the locked position.

NOTE: If the reagent containers are not full, replace the reagents prior to starting the system (see “Reagent Replacement” on page 7.4 for details).

• Verify both paraffin ovens contain sufficient

amounts of paraffin.

If necessary, verify the Unloading Station retort contains

a sufficient amount of paraffin.

NOTE: If sufficient paraffin is not available in either paraffin oven, replace the paraffin prior to starting the system (see

“Retort #3 and #4 Paraffin Replacement” on page 7.5 and “Unloading Station Paraffin Replacement” on page 7.7 for

details).

NOTE: It is recommended to ensure proper processing of tissue specimens, reagent sets MUST be changed at the same time.

Pre-Start Checks

Prior to the first processing run each day, perform the

following pre-start checks and services:

• Verify a new drip tray liner has been placed on the

Transfer Arm drip pan.

NOTE: If necessary, replace the drip tray liner on the Transfer Arm drip pan (see “Drip Tray Liner Replacement” on page 7.7 for details).

• Verify that the Loading Station container is filled

with Pre-Processing Solution (product code 7115).

• Verify the handle of the loading station container is

resting on the rim of the container.

• Verify the Transfer Arm is not holding a basket or

magazine set, and that there are no or magazines baskets in the Loading Station, Unloading Station, or in any retort.

• Verify that all retort lids are closed. If any lids are

open, close them manually.

2.2 Revised 10/02/2012

Page 23

(Product Code 4807)

Unpacking and Installation

Description Quantity

Tissue-Tek® Xpress® x120 Accessories

Confirm that the following accessories are provided with

the instrument.

Description Quantity

Paraffin Scraper (Product Code 1550)

Trimming Knife Blades, 130mm* (Product Code 4785)

Trimming Knife Handle* (Product Code 4786)

Scalpel Handle* (Product Code 4791)

Scalpel Blades, #62* (Product Code 4793)

Grossing Wells (Product Code 4802)

1 pack of 10

1 pack of 20

1 set

Basket Transportation Tray (Product Code 7109)

Drip Tray (Product Code O71-169-01)

Reagent Bottle Tray (Product Code O71-355-00)

Retort Cleaning Pipette (Product Code D9-01-0102)

Retort Mesh Filter Removal Tool (Product Code O71-692-00)

Sight Tube Cleaning Brush (Product Code O71-697-00)

Grossing Wells, Left Handed (Product Code 4848)

Grossing Fork, 1.5mm (Product Code 4803)

Grossing Fork, 2.0mm (Product Code 4804)

Grossing Fork, 2.5mm

Basket w/ Handle and Lid, 40-cassette (Product Code 7103)

Tray Liners (Product Code 7106)

Loading Station Container w/ Lid (Product Code 7108)

1 set

1 pack of 20

Spill Tray (Product Code O71-491-00)

Unloading Station Container (Product Code F60-153-00)

Container Kit (Product Code 7190)

Operating Manual (Product Code 0004398-01)

*Not applicable to Model 7721

Missing or Damaged Items?

Check the contents of all shipping cartons and boxes carefully for all of the listed items. If any items are visibly damaged, or are missing, call 1-800-725-8723 or 1-310972-7800 (U.S. Customers only). When located outside the U.S., contact the nearest Sakura instrument distributor.

Revised 10/02/2012 2.3

Page 24

INSTALLATION

2.4 Revised 10/02/2012

Page 25

clears the

t when

displays a status listing

on page

STATISTICS

displays statistics on the

essed

Viewing

displays a log of errors that

have occurred in monitored operations,

Viewing the

tured for System

CUSTOMIZATION OF SETTINGS

General Information

The Tissue-Tek® Xpress® x120 allows for the customization of a number of system options and operating parameters to suit the user requirements of a given installation. The UTILITIES menu provides the means of viewing the current system settings, of selecting and configuring system options, and specifying the desired values for user-configurable operating parameters.

This section provides the procedures to perform initial setup of the Tissue-Tek Xpress x120 system settings. Factory default settings for each parameter are listed where applicable.

Perform the following setup procedures before routinely using the Tissue-Tek Xpress x120 system. In addition, perform these procedures as needed to reset the clock, add or remove users, change automatic, start-up, and shut-down times, etc.

NOTE: Refer to “Control Panel (Figure 1-O)” on page 1.12 for a description of the controls and indicators used in performing setup procedures.

• If the login request is successful: The WARMING

UP SYSTEM screen displays while the system warms up, then the MANUAL START or AUTO START screen displays, as appropriate. Press the UTILITIES key to display the UTILITIES menu (Figure 3-A).

Section 3

Figure 3-A

Accessing the UTILITIES Menu

NOTE: Login as an Administrator in order to modify

system settings through the UTILITIES menu. Logging in with an Operator’s password allows “read-only” access to the UTILITIES menu (current system settings may be viewed, but cannot be changed).

To access the UTILITIES menu:

1. From the WARMING UP SYSTEM screen, MANUAL

START screen or AUTO START screen, touch the LOG ON button.

• The INPUT PASSWORD dialog displays.

• Use the keypad to enter the password, then

touch the ENTER key.

NOTE: The password is displayed on the screen, as

entered, as a series of asterisks.

• If the login is unsuccessful: When password is

incorrectly entered, the message “INCORRECT PASSWORD ENTERED” displays. Reenter the password, then press the ENTER key to resubmit the login request.

2. From the UTILITIES menu, select to perform the

following operations:

REAGENT COUNT CLEAR – cumulative cassette or run coun replacing reagents (see “Reagent R placement” on page 7.4 for details).

RUN HISTORY – for each completed processing run initia ed (see “Viewing Run History”

4.14 for details).

– number of cassettes/runs/days proc for a selected time period (see “ Statistics” on page 4.14 for details).

ERROR LOG –

systems or components (see “

Error Log” on page 4.16 for details).

SHUTDOWN – facilitates manual shu

down of the instrument when config MANUAL START operation (see “ Shutdown” on page 4.10 for details).

Revised 10/02/2012 3.1

Page 26

CUSTOMIZATION OF SETTINGS

SOFTWARE VERSION

mation related to instrument software and

umber (see

on page

lectable” options and

Configuring

e addition,

and removal of system users

allows for the

and removal of assignable “identifiers” for use as sorting criteria for the Run History File and

down times

for automatic operation of the system (see

” on

allows for

tion of a “recovery process” for

cessing is interrupted (aborted) due to an

Section 5, Recovery

PROCESS RECOVERY

button is enabled only during the

– displays info

firmware versions and serial n “Viewing the Software Version”

4.14 for details).

SYSTEM SETUP – allows for the config ration of “user-se operating parameters (see “

System Settings” on page 3.2 for details).

PASSWORDS – allows for th

modification, (see “Setting Names and Passwords” page 3.4 for details).

USER DEFINED FILE – addition, modification,

for the instrument (selected parameters are indicated by a “gray” background).

Figure 3-B

Statistics (see “Managing the User D fined File” on page 3.6 for details).

READY / SHUTDOWN TIMES – esta lishes the start-up and shut-

“Setting Ready / Shutdown Times page 3.7 for details).

PROCESS RECOVERY – initia baskets in Retorts #3 and #4 when pr

error condition (see “ Process” for details).

NOTE: The

WARMING UP SYSTEM cycle.

Configuring System Settings

The SYSTEM SETUP option allows changes to “userselectable” and “user-specified” system settings and parameters.

To change system settings:

1. From the UTILITIES screen, touch the SYSTEM

SETUP button.

• SYSTEM SETUP screen, page 1, displays (Figure

3-B), showing the currently selected parameters

3.2 Revised 10/02/2012

NOTE: The SYSTEM SETUP screen is a multi-page display screen.

• Use the PREVIOUS and NEXT buttons in the

lower right-hand corner of the screen to toggle between pages.

2. Make changes to the following system settings

/parameters on SYSTEM SETUP, page 1, as desired:

• REAGENT CONTROL – sets the units by which

reagent use is calculated (a cumulative count of the selected units is shown on the WARMING UP SYSTEM screen, MANUAL START screen and AUTO START screen).

Touch the desired option field, either CASSETTES or RUN.

The factory default setting for REAGENT

CONTROL is CASSETTES.

NOTE: To not use the REAGENT CONTROL function, select the NOT IN USE option.

• COUNT LIMIT – sets the count limit for the asso-

ciated REAGENT CONTROL options (the COUNT LIMIT indicates the maximum number of cassettes/runs that may be processed before reagent replacement is necessary).

Touch the desired field to display the data entry keypad. Enter the desired value, then touch the ENTER key to close the keypad. The factory default settings for COUNT LIMIT are 1000 cassettes and 25 runs.

Page 27

• UPS – indicates whether or not an external Unin-

terruptible Power Supply (UPS) is connected to the instrument.

Touch the appropriate option field, either IN USE or NOT IN USE.

The factory default setting for UPS is IN USE.

• OUTPUT –To determine method to export vari-

ous data that Tissue-Tek Xpress x120 system recorded.

Touch the desired option field, either PRINT or

FILEOUTPUT. The factory default setting for OUTPUT is FILE OUTPUT. (See “To Print Sys-

tem Setting” on page 3.4 for more information).

• EDIT ITEM – indicates whether or not the USER

DEFINED FILE option is enabled (see “Managing the User Defined File” on page 3.6 for more information).

Touch the appropriate option field, either IN USE or NOT IN USE.

The factory default setting for EDIT ITEM is NOT IN USE.

• FILE NAME – indicates the file name for the

USER DEFINED FILE.

The factory default setting for FILE NAME is SampleItem.

3. Touch the NEXT button to display the SYSTEM

SETUP screen, page 2 (Figure 3-C). Make changes to the following system settings/parameters on SYSTEM SETUP screen, page 2, as desired:

Figure 3-C

• SOUND VOLUME - sets the volume for “key

clicks” and the audible “end of process” and “alarm” indications.

Touch the desired option field, either HIGH (audible within 100 feet of instrument), MIDDLE (audible within 50 feet of instrument) or LOW (audible within 10 feet of instrument).

The factory default setting for SOUND VOLUME is MIDDLE.

NOTE: Touch the TEST CLICK, TEST ALARM, or TEST END OF PROCESS button to test the selected SOUND VOLUME.

• SOUND SELECTION – allows for selection of

the desired “end of process” and “alarm” sounds from one of seven available options.

Touch the desired field to display a drop-down menu of available options, then select the desired option.

The factory default settings for SOUND

SELECTION are ENDOFPROC1 and ALARM1.

NOTE: Touch the TEST ALARM or TEST END OF PROCESS button to test the selected SOUND SELECTION.

• END OF PROCESS SOUND INTERVAL – se-

lects the interval at which the “end of process” sound is repeated.

Touch the desired option field, either CONTINUOUS, INTERMITTENT, or SINGLE.

The factory default setting for END OF PROCESS SOUND INTERVAL is CONTINUOUS.

• LANGUAGE – selects the display language for

the instrument display screens.

Touch the desired field to display a drop-down menu of available options, then select the desired option.

The factory default setting for LANGUAGE is ENGLISH.

• DATE FORMAT – sets the format for the date

display shown at the top of all instrument display screens.

Touch the desired option field, either YMD, MDY, or DMY.

The factory default setting for DATE FORMAT is MDY.

Revised 10/02/2012 3.3

Page 28

CUSTOMIZATION OF SETTINGS

• TIME FORMAT – sets the format for the time

display shown at the top of all instrument display screens.

Touch the desired option field, either 12 HOUR or 24 HOUR.

The factory default setting for TIME FORMAT is 12 HOUR.

• DATE AND TIME - establishes the current cal-

endar date and time-of-day shown on all instrument display screens.

Touch the desired field to display the data entry keypad. Enter the appropriate value, then touch the ENTER key to close the keypad.

NOTE: Be sure to enter the date using the same format as selected for the DATE FORMAT. For example, if YMD is selected as the DATE FORMAT, enter March 10, 2002 as “02/03/10”.

4. When all desired system settings/parameters have

been changed, touch the SAVE & EXIT button to save the new settings to memory and return to the UTILITIES screen.

NOTE: To return to the UTILITIES screen without changing the SYSTEM SETUP, press the EXIT button.

To return to the factory default settings:

1. From the UTILITIES screen, touch the SYSTEM

SETUP button.

• SYSTEM SETUP screen, page 1, displays (Figure

3-B), showing the currently selected parameters for the instrument (selected parameters are indicated by a “gray” background).

2. Touch the RESET DEFAULTS key to return system

settings to the factory default values.

3. The system returns to the UTILITIES screen.

1. From the UTILITIES screen, touch the SYSTEM

SETUP button.

• SYSTEM SETUP screen, page 1, displays

(Figure 3-B), showing the currently selected parameters for the instrument.

2. Touch the PRINT button.

Setting Names and Passwords

The PASSWORDS option performs the following func-

tions:

• Set the Institution Name shown on all Tissue-Tek

Xpress x120 display screens

• Add, edit, or delete names and passwords for up to

4 Tissue-Tek Xpress x120 system Administrators

• Add, edit, or delete names and passwords for up

to 20 Tissue-Tek Xpress x120 system Operators

Passwords determine the features and functions available to Tissue-Tek Xpress x120 users. Operator passwords limit access to routine operations of the system. Administrator passwords allow access to all system functions and user-programmable features.

NOTE: A default Administrator’s name “ADMIN 1” and password “100000” are provided to allow access to setup functions for initial configuration of the system. The default password should be replaced with a unique password to prevent unauthorized access to the system.

To print system settings:

NOTE: The PRINT option allows users to export a file to a

USB memory stick.

• FILE OUTPUT-exports a CSV file to a USB

memory stick

• PRINT-exports a PDF file to a USB memory

stick.

3.4 Revised 10/02/2012

Page 29

To access the PASSWORDS function:

1. From the UTILITIES screen, touch PASSWORDS button.

• The PASSWORDS screen displays (Figure 3-D),

showing the current Institution name, and Administrator and Operator names and passwords.

Figure 3-D

NOTE: The PASSWORDS screen is a multi-page display

screen.

2. Use the PREVIOUS and NEXT buttons in the lower

right-hand corner of the screen to scroll through other pages of the display.

To add or edit users:

1. Touch the NAME field of the user chosen for edit.

• The EDIT NAME AND PASSWORD screen dis-

plays (Figure 3-E).

NOTE: Use the backspace key to edit a currently entered name.

2. Touch the NAME field, then use the keyboard to enter

the desired user name.

3. When the desired name has been entered in the

NAME field, press the ENTER key.

NOTE: When editing the Institution name, the PASSWORD and REENTER fields are not displayed.

4. Touch the PASSWORD field, then use the keyboard

to enter the desired password. The password displays as a series of asterisks when entered.

NOTE: The password must be a six-digit numeric password. DO NOT use alphabetic characters in the password.

5. When the desired password has been entered in the

PASSWORD field, press the ENTER key.

6. Touch the REENTER field, then use the keyboard to

reenter the password as entered in step 4.

7. When the password has been reentered in the

REENTER field, press the ENTER key.

8. When the desired name and password for the user

have been entered, press the EXIT key to return to the PASSWORDS screen.

9. Repeat steps 1 through 8 to add or edit name and

passwords for other users.

10. When all desired user names and passwords have

been edited, press the EXIT button to return to the UTILITIES screen.

To delete users:

1. Touch the ADMINISTRATOR or OPERATOR button

for the user chosen for deletion, then press the delete key. The screen refreshes with the selected user NAME and PASSWORD deleted.

2. Repeat step 1 to delete other users.

3. When all desired users have been deleted, press the

EXIT button to return to the UTILITIES screen.

Figure 3-E

Revised 10/02/2012 3.5

Page 30

CUSTOMIZATION OF SETTINGS

Managing the User Defined File

The USER DEFINED FILE function allows for creating “identifiers” that can be assigned to a basket or Paraform magazines on loading. The “identifiers” can then be used as sorting criteria for the run History File and Statistics. The USER DEFINED FILE can contain any “identifiers” that are appropriate to installation and workflow (such as doctor’s names or hospital departments).

For example, specimens that are for the same doctor can be grouped in a single basket, and the doctor’s name assigned to the basket or sets of Paraform magazines during setup and loading.

NOTE: The EDIT ITEM option in SYSTEM SETUP must be set to IN USE to enable this function (see “Configuring System Settings” on page 3.2 for details).

To access the USER DEFINED FILE function:

• The EDIT USER DEFINED ITEM screen displays

(Figure 3-G).

Figure 3-G

1. From the UTILITIES screen, touch the USER

DEFINED FILE button.

• USER DEFINED FILE screen displays (Figure 3-F),

a listing of the current items (identifiers) in the file.

Figure 3-F

• Use the scrollbar to view the complete list.

• Up to 99 items can be entered.

NOTE: The USER DEFINED FILE is unsorted. Items are listed in the order in which they were entered.

To edit an item in the file:

1. Touch the name of the item chosen for edit in the

USER DEFINED FILE list, then touch the EDIT button.

NOTE: Use the backspace key to edit a currently entered name.

2. Touch the NAME field, then use the keyboard to edit

the current item (identifier) name.

3. When the item NAME has been edited as desired,

touch the ENTER key.

4. Press the EXIT key to return to the USER DEFINED

FILE screen.

5. Repeat steps 1 through 4 to edit additional items in

the list.

6. When all desired items have been edited, touch the

SAVE & EXIT button to save the changes and return to the UTILITIES screen.

NOTE: To return to the UTILITIES screen without changing the USER DEFINED FILE, press the EXIT button.

To delete an item from the file:

1. Touch the name of the item to delete from the USER

DEFINED FILE list, then touch the DELETE button.

• The screen refreshes with the selected item re-

moved from the list.

2. Repeat step 1 to delete additional items from the list.

3. When all desired items have been deleted, touch the

SAVE & EXIT button to save the changes and return to the UTILITIES screen.

3.6 Revised 10/02/2012

Page 31

NOTE: To return to the UTILITIES screen without changing the USER DEFINED FILE, press the EXIT button.

Setting Ready / Shutdown Times

The READY / SHUTDOWN TIMES option sets the automatic warm-up (ON) and automatic shutdown (OFF) times for the Tissue-Tek Xpress x120 for days on which the system will normally be used (see “Setting Days Off” on page 3.8 for more information). READY/SHUTDOWN times may be set individually for each day of the week, or the same times may be set for all days of the week. It is also possible to indicate days on which the system is not in use (automatic warm-up and shutdown is not performed).

To access the READY / SHUTDOWN TIMES function:

1. From the UTILITIES screen, touch the READY /

SHUTDOWN TIMES button.

• The READY/SHUTDOWN TIMES screen dis-

plays (Figure 3-H), showing the current system ON

TIME and OFF TIME for each day of the week.

NOTE: When entering ON / OFF TIME, be sure to enter

the desired times using the appropriate format, either 12-hour or 24-hour, as established in SYSTEM SETUP (see “Configuring System Settings” on page 3.2 for more information).

Figure 3-H

To set on/off times for a single day:

1. Touch the ON TIME or OFF TIME field for the desired

day of the week (MONDAY through SUNDAY).

NOTE: Use the backspace key to edit a currently entered time.

2. Use the keypad to enter the desired “on” time (the

time at which the instrument should be ready to begin processing) or “off” time (the time at which the instrument should normally shutdown).

3. When the desired time has been entered in the active

field, press the ENTER key.

4. Repeat steps 1 through 3 to set the ON TIME and

OFF TIME for the remaining days of the week.

5. When all desired on/off times have been entered or

edited, touch the SAVE & EXIT button to save the changes and return to the Utilities screen.

NOTE: To return to the UTILITIES screen without changing on/off times, press the EXIT button.

NOTE: On/off times will repeat weekly, unless “days off” are specified (see “Setting Days Off on page 3.8 for more information).

To set the same on/off times for all days:

1. Touch the EVERYDAY - ON TIME or EVERY DAY -

OFF TIME field

NOTE: Use the backspace key to edit a currently entered

time.

2. Use the keypad to enter the desired “on” time (the

time at which the instrument should be ready to begin processing) or “off” time (the time at which the instrument should normally shutdown).

3. When the desired time has been entered in the active

field, press the ENTER key.

4. When the desired EVERY DAY on/off times have

been entered or edited, touch the SAVE & EXIT button to save the changes and return to the Utilities screen.

NOTE: To return to the UTILITIES screen without changing on/off times, press the EXIT button.

NOTE: EVERY DAY on/off times will repeat daily, unless “Days Off” are specified (see “Setting Days Off” on page

3.8 for more information).

Revised 10/02/2012 3.7

Page 32

CUSTOMIZATION OF SETTINGS

To set A “Not In Use” day:

To use the “days off” calendar:

NOTE: “Not In Use” days should be set only for days on

which the instrument will not normally be operated.

1. Touch the ON TIME or OFF TIME field for the desired

day of the week (MONDAY through SUNDAY).

2. Touch the NOT IN USE key, then press the ENTER key.

3. When the desired “Not In Use” days have been set,

touch the SAVE & EXIT button to save the changes and return to the Utilities screen.

NOTE: To return to the UTILITIES screen without changing on/off times, press the EXIT button.

To determine the mode of operation for the TissueTek Xpress x120 system:

Touch the desired option field, either AUTO (instrument is started and shutdown automatically, according to the scheduled READY/SHUTDOWN TIMES) or MANUAL (instrument must be started manually before use and shutdown manually after use)

Setting Days Off

The DAYS OFF option overrides the normal on/off time settings for selected dates on which the instrument will not be used, such as holidays, vacation days or other scheduled days off.

To access the DAYS OFF function:

1. From the UTILITIES screen, touch the READY /

SHUTDOWN TIMES button.

• The READY/SHUTDOWN TIMES screen dis-

plays (Figure 3-H), showing the current system ON TIME and OFF TIME for each day of the week.

2. Touch the DAYS OFF button.

• The DAYS OFF screen displays (Figure 3-I),

showing the “days off” calendar for the current month. Currently specified “days off” are indicated by a red circle around the date.

• The DAYS OFF LIST lists all currently specified

“days off”, in chronological order.

• Days off can be selected by using the calendar.

• Days off can be deselected by using either the

calendar or the DAYS OFF LIST.

1. Use the PREVIOUS and NEXT buttons at the top of

the screen to scroll the calendar to the desired month.

Figure 3-I

2. To add a “day off”, touch an unselected day on the

calendar. The screen refreshes to display a red circle around the selected day, and the selected date is added to the DAYS OFF LIST.

3. To remove a “day off”, touch a selected day on the

calendar. The screen refreshes with the red circle removed from the selected day, and the selected date is deleted from the DAYS OFF LIST.

4. When all desired “days off” have been specified,

touch the SAVE & EXIT button to save the changes and return to the READY/SHUTDOWN TIMES screen.

NOTE: To return to the READY/SHUTDOWN TIMES screen without changing “days off”, press the EXIT button.

To use the DAYS OFF LIST:

The DAYS OFF LIST shows a complete listing of all

currently specified “days off.”

1. Use the scrollbar to scroll through the DAYS OFF LIST.

2. To remove a “day off”, touch the desired date in the

DAYS OFF LIST, then touch the DELETE key.

3. Touch the SAVE & EXIT button to save the changes

and return to the READY/SHUTDOWN TIMES screen.

NOTE: To return to the READY / SHUTDOWN TIMES screen without changing “days off”, press the EXIT button.

3.8 Revised 10/02/2012

Page 33

Indicates the

OPERATING INSTRUCTIONS

Initial Setup

Ensure that initial setup procedures have been performed in accordance with the requirements of Section 3, Customization of Settings, prior to operating the Tissue-

Xpress® x120 instrument.

Tek

Understanding the Control Panel Display

The Control Panel provides the controls and indicators necessary to initiate a processing cycle, monitor the status of individual baskets or Paraform processing, configure system setting, manage user, and view statistical reports.

Process Monitor Screen

The Process Monitor screen (Figure 4-A) is displayed when the system is ready for processing, and during processing cycles. The Process Monitor screen is comprised of a screen header, process monitor window, information window, and button bar.

magazines during

indicators for the Loading Station and Unloading Station access doors. The indicators show when the associated access door can be opened to load or unload baskets or Paraform magazines, as follows:

and Vacuum retorts, and Unloading Station, and provides tabular data related to the status of baskets currently being processed (see “Process Monitoring” on page 4.8 for details). The currently selected operational mode (MANUAL START or AUTO START) is shown in the upper left-hand corner of the window. The currently selected processing program (STANDARD PROGRAM or EXTENDED PROGRAM) is shown in the upper right-hand corner of the window.

The process monitor window also provides status

Section 4

Access Permitted Icon – associated access door may be opened to allow loading or unloading, as applicable.

NOTE: The Loading Station Access Permitted Icon is active only when a user is

logged on to the instrument.

Access Denied Icon – associated access door may not be opened.

When displayed for the Loading Station, one of the following conditions exists:

• A basket or magazine set is currently in

the Loading Station retort.

• The Transfer Arm is in motion.

• A reagent shortage is detected.

When displayed for the Unloading Station, one of the following conditions exists:

• The Transfer Arm is in motion.

Figure 4-A

• The screen header shows the current date and

time, the name of the hospital, laboratory, or institution where the instrument is installed, and the name of the currently logged on user (if no user is currently logged on, the field is blank).

• The process monitor window provides a pictorial

representation of the Loading Station, Microwave

Revised 10/02/2012 4.1

• The information window provides the following

information:

CASSETTE or RUN COUNT – The number of cassettes or runs processed since the last reagent change.

CASSETTE or RUN COUNT LIMIT – The total number of cassettes or runs that may be processed, as applicable, before it is necessary to replace the reagents.

LAST REAGENT CHANGE – The date and time at which the reagents were last replaced and the reagent counter was cleared.

TOTAL CASSETTES or RUNS – The total number of cassettes or runs, as applicable, that have

Page 34

OPERATING INSTRUCTIONS

been processed since the instrument was installed.

READY-SHUTDOWN – When the instrument is configured for Auto Start / Shutdown, shows the start and shutdown times for the current day. When the instrument is configured for Manual Start / Shutdown, shows the word MANUAL.

• The button bar provides the controls to log on

and log off the instrument, and to access the UTILITIES menu (see Section 3, “Customization of Settings” for details).

Preparation for Processing

The Tissue-Tek Xpress x120 instrument supports the use of standard cylindrical baskets, or Paraform magazines (for use in conjunction with the Tissue-Tek AutoTEC

Automated Embedding System).

CAUTION: Do not use cassettes that contain any metal or use metal lids. When placing cassettes into the basket, do not allow any cassettes to extend above the maximum limit rim. Cassettes placed above the maximum limit rim will not be fully immersed in the reagents, and will not be processed properly.

The Standard Basket incorporates a removable handle and lid to allow for easy loading and positioning of cassettes in the basket.

To remove the basket handle (Figure 4-C):

1. Press down on the basket handle until the handle

releases from its locking slots.

2. Turn the handle clockwise until it is aligned with the

recesses in the basket, then pull the handle free from the basket.

Using the Standard Basket

The Standard Basket (Figure 4-B) is a cylindrical basket designed to hold up to 40 cassettes. The upper band (maximum limit rim) of the basket indicates the maximum height at which cassettes in the basket may be placed.

Figure 4-C

To install the basket handle (Figure 4-C):

1. Insert the basket handle into the recesses in the basket.

2. Turn the handle counterclockwise until it stops, then

pull up on the handle to engage the locking slots.

3. The lid can be placed inside the basket prior to

processing.

Using Paraform Magazines

Figure 4-B

4.2 Revised 10/02/2012

If the embedding process is performed by the Tissue-

AutoTEC® Automated Embedding System, a special

Tek handle is supplied with the Tissue-Tek AutoTEC. This handle allows two Tissue-Tek Paraform magazines to be

Page 35

linked together by sliding the magazines into the handle slots. Each magazine can hold up to 20 Paraform cassettes.

Preparing the Tissue Specimens

The specific procedures to be used when preparing tissue specimens for processing using the Tissue-Tek Xpress x120 instrument depend on tissue type, specimen size, and other factors.

Detailed instructions for preparing tissue samples prior to processing using the Tissue-Tek Xpress x120 instrument are provided in Appendix A.

CAUTION: Failure to follow the appropriate preprocessing procedures may result in improper processing of the specimens.

System Start Up

The Tissue-Tek Xpress x120 instrument may be configured for either automatic start / shutdown at preprogrammed times, or for manual start (see “Configuring System Settings” on page 3.2 for details). Following startup, the instrument enters a WARMING UP SYSTEM cycle, where the various reagents are warmed to the appropriate temperatures for processing operations. Once the WARMING UP SYSTEM cycle is concluded, the instrument is ready to perform processing.

instrument (see Control Panel (Figure 1-O) on page 1.12 for details).

NOTE: If it is necessary to start the instrument prior to its programmed “ready” time, use the “Manual Start” procedure to manually start the instrument. Starting the instrument manually will not affect the auto shutdown cycle for the current day, and auto start will occur at its next scheduled start time.

Manual Start

When the instrument is configured for Manual start, the

instrument must be started manually.

To perform a Manual start of the instrument:

1. Make sure the “Pre-Start Checks” have been

performed, and the instrument is ready to start.

2. If necessary, apply Main Power to the instrument.

NOTE: The instrument is designed to remain powered continuously. In most cases, it will be necessary to apply Main Power to the instrument only following initial installation, or when it has been turned off for servicing or repair.

3. Press the START button on the right side panel

above the power switch. The operating software loads, and the Tissue-Tek Xpress x120 Startup screen displays (Figure 4-D). The Transfer Arm moves to its “home” position, and the instrument enters the WARMING UP SYSTEM cycle.

Auto Start

WARNING: WHEN THE INSTRUMENT IS CONFIGURED FOR AUTO START, IT IS NECESSARY TO PERFORM THE “PRE-START CHECKS” FOLLOWING SHUTDOWN OF THE INSTRUMENT IN ORDER TO ENSURE THE INSTRUMENT IS READY TO START AT ITS PREPROGRAMMED TIME.

The Auto Start / Shutdown feature allows the instrument to be configured to automatically start up and be ready for processing by a specified “ready” time. When auto start is enabled, the instrument is started prior to the desired “ready” time in order to allow the WARMING UP SYSTEM cycle to be completed by the desired time.

When the Auto Start / Shutdown feature is enabled, the Auto Start / Shutdown indicator on the User Interface is illuminated at all times that power is applied to the

Revised 10/02/2012 4.3

Figure 4-D

Page 36

OPERATING INSTRUCTIONS

System Warm Up (Figure 4-E)

Figure 4-E

right-hand corner of the screen, and the name of the user is shown at the top of the screen. The system will not allow logging on to the instrument until the current user has logged off.

1. Touch the LOG ON button located in the lower right-

hand corner of the screen. The PASSWORD dialog displays (Figure 4-F).

The WARMING UP SYSTEM cycle allows all reagents to warm to the appropriate temperature prior to automatic processing. Depending on the state of the system before starting, the time required to complete the WARMING-UP SYSTEM process may be as long as 4.5 hours. The TIME TO READY field in the upper right-hand corner of the display shows the time remaining until the cycle is complete.

During the WARMING UP SYSTEM cycle, the control panel display changes to indicate the current status of the cycle. Current temperatures for the retorts, Unloading Station, and paraffin ovens are displayed, in ºC, and are periodically updated as the cycle progresses.

Once the WARMING UP SYSTEM cycle has completed, reagents in retorts #1 and #2 are maintained at the correct temperature until a basket or magazine set is loaded and processing begins.

Logging On

Log on to the system before initiating processing operations or accessing the UTILITIES menu. Only one user may be logged on to the instrument at any time. It is possible to log on to the instrument during the WARMING UP SYSTEM cycle, or when the instrument is in the MANUAL or AUTO START process monitor mode.

Figure 4-F

2. Use the keypad to enter the six-digit password in the

INPUT PASSWORD text box.

NOTE: If needed, use the backspace key

errors when entering the password. Touch the CANCEL key to delete all characters from the INPUT PASSWORD text box.

3. When the correct password has been entered, touch

the ENTER button to complete the log on process. The PASSWORD dialog closes, and the previous screen refreshes to show the user name at the top of the screen.

NOTE: To cancel the log on process, make sure the INPUT PASSWORD text box is empty, then touch the ENTER key. The PASSWORD dialog will close and the

system will return to the previous screen.

to correct

To log on to the instrument:

NOTE: If another user is current logged on to the

instrument, the LOG OFF button is shown in the lower

4.4 Revised 10/02/2012

Page 37

Logging Off the System

NOTE: After loading a basket and initiating a processing cycle, it is recommended to log off the instrument if individual passwords have been assigned to users. This ensures that the next user must log on before initiating a processing cycle, and helps maintain an accurate history of processing by each user.

To log off of the instrument:

Touch the LOG OFF button in the lower right-hand corner of the screen. The screen refreshes, and the user name is removed from the top of the screen to confirm a successful log off.

System Operation

System operation is comprised of four phases:

Figure 4-G

• Loading Tissue Specimens – A prepared bas-

ket or magazine set of specimens is placed in the Loading Station retort, and the information necessary to initiate the processing cycle is entered using the Control Panel.

• Preprocessing –Tissue samples processed on

the Tissue-Tek preparation and handling to ensure optimal results. An optional online step is available to pretreat tissue specimens prior to tissue processing. Pre-Processing Solution (PPS) Product Code 7115 is used in the loading station. Users have

Xpress® x120 require proper

the ability to set the onboard preprocessing time between 0-60 minutes. Once a preprocessing cycle has been initiated, the preprocessing operation is performed automatically, under the control of the scheduling software and based on the selected preprocessing time. The Control Panel displays a “process monitor” screen that allows tracking the status of a basket or magazine set through the preprocessing cycle.

NOTE: Do not transport or leave specimens in PPS overnight as this is a timed solution and over exposure will compromise the tissue samples.

• Process Monitoring – Once a processing cycle

has been initiated, all processing operations are performed automatically, under control of the scheduling software, and based on the currently selected processing program. The Control Panel displays a “process monitor” screen that allows tracking the status of a basket or magazine set through the processing cycle.

• Unloading Processed Specimens – Once au-

tomated processing is completed, the processed basket is placed in the Unloading Station for unloading and for transfer to an embedding station.

NOTE: The user must be logged on to the instrument to load tissue specimens and initiate a processing cycle (see “Logging On” on page 4.4 for details). It is not necessary to log on in order to unload processed specimens.

Two programs can be selected in the program selection pull down list. The STANDARD program immerses the specimens for 15 minutes in each retort. The EXTENDED program immerses the specimens for 30 minutes in each retort. Touch the drop down arrow to view the two programs and then touch the desired selection (Figure 4-G).

NOTE: The program selection can only be made when the instrument is ready, but not processing specimens.

Revised 10/02/2012 4.5

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OPERATING INSTRUCTIONS

Setting Onboard Preprocessing Times

Loading Tissue Specimens and Initiating a Processing Cycle

If this optional online preprocessing step is selected during setup, processing times will be altered accordingly. A basket cannot move to the next retort until the set preprocessing time expires and/or a retort is available.

NOTE: Only administrators have the ability to change the onboard preprocessing times.

CAUTION: Do not transport or leave specimens in PPS overnight as this is a timed solution and over exposure will compromise this tissue samples.

1. Touch the Loading Station icon.

• A PREPROCESSING SETTINGS window dis-

plays (Figure 4-H).

Figure 4-H

Preprocessing Solution Expiration Time Range Time Range

2. Tap inside the PREPROCESSING TIME field box. Use

the keypad to enter a time between 0 and 60 minutes.

• If zero minutes are entered, the function is disabled.

3. Tap inside the SOLUTION EXPIRATION TIME field box.

Use the keypad to enter a time between 0 and 24 hours.

• If zero hours are entered, the function is disabled.

NOTE: It is recommended to change the onboard preprocessing solution every 3 hours.

4. Touch ENTER.

After the WARMING-UP SYSTEM cycle has completed, the Control Panel displays the PROCESS MONITOR screen (see “Process Monitor Screen” on page 4.1 for details). The instrument is now ready to process specimens.

To load a basket or magazine set and initiate a processing cycle:

1. Verify the instrument is ready to accept a basket or

magazine set by observing the following conditions:

• The Loading Station Access Permitted Icon is

displayed on the left-hand side of the screen.

• The Loading Indicator is illuminated.

NOTE: If the instrument is not ready to accept a basket, and a basket or magazine set is loaded into the instrument, the processing cycle will not be started, and a message will display on the Control Panel screen. Remove the basket from the Loading Station and wait until the instrument is ready to accept a basket or magazine set.

2. Log on to the instrument if necessary (see “Logging

On” on page 4.4 for details).

NOTE: The user must be logged on to the instrument to initiate a processing cycle. If the user is not logged on when a basket or magazine set is loaded into the instrument, the processing cycle will not be started, and a message will display on the Control Panel screen.

3. Open the Loading Station Access Door (Figure 4-I). If

necessary, remove the cover from the Loading Station retort.

Figure 4-I

4.6 Revised 10/02/2012

Page 39

4. Place the basket or magazine set directly into the

Loading Station retort (Figure 4-J). Close the Loading Station Access Door.

Figure 4-J

CAUTION: The Loading Station retort has slots ( Figure 4-K) positioned at the front and rear of the retort. Make sure the tabs of the basket handle engage these slots when the basket or magazine set is placed in the retort. If the basket is not positioned properly, the Transfer Arm will not be able to grasp it firmly.

Figure 4-K

5. Close the Loading Station Access Door.

• If REAGENT CONTROL is set to CASSETTES,

the CASSETTE COUNT data entry dialog displays (Figure 4-L). Use the keypad to enter the number of cassettes contained in the basket or magazine set to be processed in the INPUT

NUMBER OF CASSETTES text box.

..1

..,

Figure 4-L

NOTE: If needed, use the backspace key

errors when entering the number of cassettes. Touch the

CANCEL key to delete all characters from the INPUT NUMBER OF CASSETTES text box. If no value is

entered in the INPUT NUMBER OF CASSETTES box, the system will default to 40 cassettes.

• If REAGENT CONTROL is set to RUN or DAY,

the system counts each basket or magazine set as a run and a day is automatically accounted for; no user entry is required.

• Select the appropriate user-defined item (loca-

tion, department, or doctor’s name) for which the cassettes are being processed from the SELECT

ITEM menu.

NOTE: If the USER DEFINED FILE is not enabled (see

Configuring System Settings on page 3.2 for details), the

SELECT ITEM menu will not be available.

6. When the necessary information has been entered,

touch the ENTER button to complete the processing cycle setup. The CASSETTE COUNT dialog closes.

7. The instrument begins the processing cycle.

• If the preprocessing option is chosen, the basket

or magazine will remain in the loading station for the predetermined time before transferring to Station #1.

• Once the basket or magazine set has been trans-

ferred from the Loading Station to Retort #1, another basket or magazine set may be loaded into the instrument for processing. The start time for the next basket or magazine set depends on the

to correct

Revised 10/02/2012 4.7

Page 40

OPERATING INSTRUCTIONS

asket or

magazine set being processed is identified by a

set preprocessing time and/or the availability of Retort #1.

NOTE: If not processing additional baskets or magazine sets at this time, logging off the instrument is recommended (see “Logging Off the System” on page 4.5 for details). This ensures that the next user must log on before initiating a processing cycle, and helps maintain an accurate history of processing by each user.

NOTE: As mentioned on page 4.4, processing will not begin if no operator is logged in, there is insufficient reagent in Retort #1, an error condition is present, the robotic arm is in motion or is scheduled to move within the next 30 seconds, or all retorts are occupied. As applicable, the system will guide with prompts to take care of these conditions. Refer to Section 8 Troubleshooting for more details.

NOTE: Processing will not start if the left or right door is ajar. An audible alarm indicating the doors are open will sound to alert the user.

If the preprocessing SOLUTION EXPIRATION TIME is reached, the following message is displayed (Figure 4-M) and the Loading Station icon changes from blue to yellow.

NOTE: Overuse of Pre-Processing Solution could lead to tissue artifacts on the stained slide.

Process Monitoring

Figure 4-N

During a processing cycle, the Process Monitor screen (Figure 4-N) provides a graphical display of the status of each basket being processed. Icons shown in the graphical display are illustrated and described below

Basket/Magazine Icon – represents a b magazine set currently in processing. Each basket or

Figure 4-M

Touch REPLACE after replacing the Pre-Processing Solution, the loading station icon changes back to blue and the SOLUTION EXPIRATION TIME is reset.

Touch LATER to continue without replacing the PreProcessing Solution, the loading station icon remains yellow and the above message is displayed every 10 minutes until the solution is replaced.

4.8 Revised 10/02/2012

system-assigned sequence number to aid in tracking.

Transfer Icon – indicates a basket or magazine set is being transferred from one retort to the next.

Loading Station Icon (Empty) – indicates the Loading Station is currently empty, and is ready to accept a basket or magazine set.

Loading Station Icon (Wait) – indicates a basket or magazine set is currently in the loading station, and is undergoing preprocessing or awaiting transfer to Retort #1 under control of the instrument’s scheduling program.

Page 41

• END TIME – shows the time at which the basket

or magazine set is scheduled to be transferred

Retort Icon (Ready) – indicates the associated retort is ready to accept a basket or magazine set.

Loading Station Icon (Yellow) – indicates the Preprocessing Solution Time has expired.

Retort Icon (Emptying) – indicates reagent is being drained from the associated retort prior to receiving a basket or magazine set.

Retort Icon (Filling) – indicates a basket or magazine set has been transferred to the retort, and the retort is being supplied with reagent.

Retort Icon (Emptying) - indicates reagent is being drained from the associated retort prior to transferring the basket or magazine set to the next retort.

Retort Icon (Processing) – indicates the basket or magazine set in the retort is currently undergoing processing.

Unloading Station Icon (Empty) – indicates the associated Unloading Station is currently empty, and is ready to accept a basket or magazine set.

Unloading Station Icon (Complete) – indicates a basket or magazine set has been transferred to the associated Unloading Station, and the processing cycle for the basket or magazine set is complete.

tor touches the associated icon.

Tabular data shown below the graphical display provides additional information related to the current status of the basket(s) or magazine set(s) being processed. The following information is provided:

• START TIME – shows the time at which the bas-

ket or magazine set was picked up from the Loading Station and transferred to a retort. This field is blank if a basket or magazine set is not currently in the associated retort.

Revised 10/02/2012 4.9

into the Unloading Station, completing processing.

• STATUS – identifies the current state of the as-

sociated retort, as follows:

LOADING STATION STATUS

EMPTY

WAIT

READY

EMPTYING

EMPTY

FILLING

PROCESS

SHORTAGE

EMPTY

COMPLETE

The Loading Station is currently empty and is ready to accept a basket or magazine set.

A basket or magazine set is currently in the loading station, and is undergoing preprocessing or awaiting transfer to Retort #1 under control of the instrument’s scheduling program.

RETORT STATUS

The associated retort is ready to accept a basket or magazine set.

Reagent is being drained from the associated retort prior to receiving a basket or magazine set.

Reagent has been drained from the associated retort, and the retort is ready to receive a basket or magazine set.

A basket or magazine set has been transferred to the associated retort, and the retort is being supplied with reagent.

The basket or magazine set in the associated retort is currently undergoing processing.

Indicates there is insufficient reagent volume to process the next basket or magazine set.

UNLOADING STATION STATUS

The associated Unloading Station is currently empty, and is ready to accept a basket or magazine set.

A basket or magazine set has been transferred to the associated Unloading Station, and the processing cycle for the basket or magazine set is complete.

The following information is available when the opera-

• TIME LEFT – shows the time remaining until the

associated basket or magazine set is transferred to the next station.

• TEMPERATURE – shows the current tempera-

ture of the associated retort. This field is blank for the Loading Station.

• CASSETTES – shows the number of cassettes

contained in the basket or magazine set in the associated retort if REAGENT CONTROL is set for CASSETTES.

Page 42

OPERATING INSTRUCTIONS

NOTE: If REAGENT CONTROL is set to RUN, the

number “40” will display in this field.

Unloading Processed Specimens

When a basket or magazine set is transferred to the Unloading Station, processing is complete, and the basket or magazine set is ready for transfer to a paraffin embedding station. When a basket or magazine set is ready for unloading, the following indications are provided:

• The Unloading Station Access Permitted Icon is

displayed on the right-hand side of the screen.

• The Unloading Indicator is illuminated.

• An audible alarm sounds briefly.

NOTE: If unable to remove the basket or magazine set immediately, the Unloading Indicator will flash continuously until the basket or magazine set is removed.

To unload a basket or magazine set:

WARNING: PROCESSED BASKETS OR MAGAZINE SETS MAY CONTAIN SOME FLUID PARAFFIN RESIDUE. USE THE TRANSPORT TRAY WHEN UNLOADING AND TRANSFERRING PROCESSED BASKETS OR MAGAZINE SETS TO PREVENT PARAFFIN DRIPS FROM FALLING TO THE FLOOR.

NOTE: It is not necessary to log on to the instrument to

unload a basket or magazine set.

1. Press the Unloading Indicator to open the lid of the

unloading station.

2. Open the Unloading Station Access Door (Figure 4-O).

Figure 4-O

3. Remove the basket or magazine set from the

Unloading Station and place the basket or magazine set on the transport tray for transportation to the paraffin embedding system (Figure 4-P).

Figure 4-P

4. Close the Unloading Station Access Door. The lid of

the Unloading Station will close automatically.

NOTE: If a basket or magazine set remains in the Unloading Station, closing the Unloading Station Access Door will reopen the lid of the Unloading Station.

System Shutdown

The Shutdown process should be performed at the end of the day for efficiency. Shutting down the system saves power and reagent. If the system is not shutdown, reagents in Retorts #1 and #2 remain heated and will slowly evaporate overnight.

When the instrument is shutdown, the following processes occur:

Reagent Drainage

• Reagents in Retorts #1 and #2 and in the pre-

heating chambers are drained into the reagent bottles.

• Paraffin in Retorts #3 and #4 is drained into the

paraffin oven.

Temperature Control

• The heaters for Retorts #1 and #2, the preheat-

ing chambers, and the Unloading Station are turned off.

4.10 Revised 10/02/2012

Page 43

NOTE: The heaters for Retorts #3 and #4, the paraffin oven, and all associated plumbing remain on to keep the paraffin in a melted state.

Computer (Controller)

• The computer switches to “sleep mode” after

completing all reagent drainage.

• The Control Panel display screen powers off.

NOTE: Shutdown cannot occur until all processing cycles are completed, and all processed baskets or magazine sets have been removed from the instrument.

Auto Shutdown

The Auto Start / Shutdown feature allows the instrument to be configured to automatically shutdown at a specified time. When auto shutdown is enabled and the instrument is idle (no baskets or magazine sets are being processed), the instrument enters the Shutdown cycle at a specified time.

When the Auto Start / Shutdown feature is enabled, the Auto Start / Shutdown indicator on the User Interface is illuminated at all times that power is applied to the instrument (see “Control Panel (Figure 1-O)” on page 1.12 for details).

NOTE: If it is necessary to shutdown the instrument prior to its programmed shutdown time, use the “Manual Shutdown” procedure to manually shutdown the instrument. Shutting down the instrument manually will not affect the auto start cycle for the next day, and auto start will occur at its next scheduled start time.

Manual Shutdown

NOTE: The user must be logged on to the instrument to

perform a manual shutdown (see “Logging On” on page

4.4 for details).

To perform a manual shutdown of the instrument:

Figure 4-Q

3. Touch the YES button to initiate a shutdown of the

instrument.

• The SHUTDOWN screen displays, showing the

status of the reagent draining process (Figure 4-R).

NOTE: The reagent draining process takes approximately four minutes to complete.

Figure 4-R

1. From the Process Monitor screen, touch the

UTILITIES button.

• The UTILITIES screen displays.

2. Touch the SHUTDOWN button.

• A confirmation dialog displays the message “ARE

YOU SURE YOU WANT TO SHUT DOWN?” (Figure 4-Q).

Revised 10/02/2012 4.11

Page 44

OPERATING INSTRUCTIONS

Special Conditions and Considerations

Understanding the Process Scheduler

In order to achieve continuous processing, the instrument’s scheduling software internally calculates a process schedule to efficiently process and transfer the specimen basket or magazine set. Depending upon the immersion times and number of baskets or magazine sets simultaneously in process, the instrument’s internal process scheduler may create a delay to prevent baskets or magazine sets from immersing too long in Retorts #1 or #2 if baskets or magazine sets in the Unloading Station are not removed.

For example, if four baskets or magazine sets are processed simultaneously, and the duration of the immersion time is 15 minutes for each of the four processing stations, the start of processing for the next basket or magazine set in the Loading Station may be delayed even though Retort #1 is READY. This is not an error. The basket or magazine set in the Loading Station will be transferred within 20 minutes.

Reagent Volume Monitor

Each time a basket or magazine set is transferred, the instrument checks the reagent volume when the reagent is pumped into retort. If the instrument detects that the reagent level is not sufficient for the next basket or set, the word, “SHORTAGE” displays in the STATUS row on the Process Monitor screen. The instrument will continue processing the basket(s) or magazine set(s) that are already in process, however, the instrument will not accept any new baskets or magazine sets until the shortage is corrected.

If a “SHORTAGE” occurs, proceed as follows:

1. Allow all baskets or magazine sets currently being

processed to complete their processing.

2. Remove the baskets or magazine sets from the

Unloading Station when processing is completed.

3. Perform a manual shutdown of the instrument (see

“Manual Shutdown” on page 4.11 for details).

4. After the shutdown process has completed, replace

all reagents (see “Pre-Processing Solution Replace- ment” on page 7.3 for details).

On board Pre-Processing Solution must be replaced on condition (after a specified number of hours) to ensure proper preprocessing. The instrument can be configured to count the number of hours the solution has been in the instrument to aid in determining when to replace the PreProcessing Solution (see “System Operation”, page 4.5).

NOTE: Depending on the types of tissues processed the Pre-Processing Solution should be replaced every 3 hours.

To replace the Pre-Processing Solution:

WARNING: THE PREPROCESSING CONTAINER MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF THE CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

1. Open the Loading Station Door.

2. Remove the loading Station Container.

3. Discard the Pre-Processing Soution per local

regulations.

4. Wipe the inside of the loading station container with

gauze.

5. Perform a manual start of the instrument (see

“Manual Start” on page 4.3 for details).

6. When the WARMING UP SYSTEM cycle is complet-

ed (see “System Warm Up (Figure 4-E)” on page 4.4

for details), the user may resume processing.

Door Open

To prevent the risk of injury due to contact with the Transfer Arm while in motion, the Transfer Arm stops moving immediately when any Access Door (Loading Station Access Door, Retort Access Door or Unloading Station Access Door) is opened during processing. The instrument resumes processing when the door is closed.

4.12 Revised 10/02/2012

Page 45

Performing an Emergency Stop

The Process Monitor screen includes an emergency STOP button to stop the motion of the Transfer Arm and all processing actions in case of emergency.

To perform an emergency stop:

1. Touch the STOP button in the lower right-hand corner

of the screen.

• The Transfer Arm stops moving immediately, and

a confirmation dialog displays the message “ROBOT ARM IS TEMPORARILY DISABLED. SELECT ‘RESUME’ OR ‘ABORT’.”

2. To cancel processing, touch the ABORT button on

the confirmation dialog.

• A confirmation dialog displays the message “ALL

RUNS WILL BE ABORTED. ARE YOU SURE YOU WANT TO ABORT ALL RUNS?”

3. To abort all runs, touch the YES button on the

confirmation dialog.

• A shutdown dialog displays the message

“REMOVE ALL BASKETS FROM RETORTS. THEN SELECT ‘GO TO STANDBY’ OR ‘SHUTDOWN’.”

4. Touch the SHUTDOWN button to shut down the

instrument.

NOTE: If baskets were in Retort(s) 3 or 4, they may be reprocessed using the “recovery” process (see Section 5, “Recovery Process” for details).

UTILITIES key to display the UTILITIES menu (Figure 4-S).

Figure 4-S

Viewing Reports and Statistics

The UTILITIES menu provides access to historical and statistical reports and information screens intended to aid in monitoring instrument usage and in monitoring and maintaining the system.

NOTE: The user must log on to the system as an Administrator in order to access all features and functions available through the UTILITIES menu (see “Logging On” on page 4.4 for details).

To access the UTILITIES menu:

• From the WARMING UP SYSTEM, MANUAL

START or AUTO START screen, press the

Revised 10/02/2012 4.13

Page 46

OPERATING INSTRUCTIONS

concluded.

User Defined

in this

Viewing the Software Version

The SOFTWARE VERSION screen displays information related to instrument software and firmware versions, and the instrument’s serial number.

To view the software version:

1. From the UTILITIES screen, touch the SOFTWARE

VERSION button.

• The SOFTWARE VERSION screen displays

(Figure 4-T).

2. The SOFTWARE VERSION screen shows the main,

master CPU, slave CPU1, slave CPU2 software version numbers, and the instrument serial number.

3. Touch the EXIT button to return to the UTILITIES

screen.

Figure 4-U

To view run history:

Viewing Run History

The system records and stores historical data related to each processing run. This information is retrieved and viewed using the RUN HISTORY function. The system stores run history for the previous 30 days.

NOTE: This feature is available to System Administrators only.

To access run history:

1. From the UTILITIES screen, touch the RUN

HISTORY button.

• The RUN HISTORY screen displays (Figure 4-U).

4.14 Revised 10/02/2012

Figure 4-T

In this example, the User Defined File has been defined as “Location”.

• The RUN HISTORY screen is comprised of a

series of data lines. There is one for each run (basket or magazine set) processed by the instrument.

• The RUN HISTORY screen provides the follow-

ing information:

DATE

RUN

START

END

OPERATOR

File

(“LOCATION”

example)

CASSETTES

STATUS

The date on which the run was processed.

The system-assigned number for the run. Each basket or magazine set unique number indicating the order in which it was processed.

The time at which the processing run was initiated.

The time at which the processing run

The operator that initiated the processing run.

The location for which the run was processed, as selected from the “SELECT ITEM” menu during setup.

NOTE: If an item was not selected during setup for a given run, the LOCATION field for that run will be blank. If no items are specified in the USER DEFINED FILE for installation, or if the USER DEFINED FILE is not enabled, the LOCATION field will always be blank.

The number of cassettes processed in the run, as entered during setup.

A brief description indicating the final status for the run.

is assigned a

• Use the scrollbar to scroll through the entire report.

Page 47

• Sort the RUN HISTORY screen chronologically

by DATE, or alphabetically by OPERATOR, or LOCATION (User Defined File). To re-sort the RUN HISTORY screen, touch the column head chosen to use as a sort key.

• Touch the EXIT button to return to the UTILITIES

screen.

To print run history:

NOTE: Two PRINT options are available, MANUAL and AUTO. Both options allow users to export a CSV file to a

USB memory stick. MANUAL allows users to generate reports as needed. AUTO generates a report every time a process is completed. The factory default setting is MANUAL.

1. From the UTILITIES screen, touch the RUN

HISTORY button.

• The RUN HISTORY screen displays (Figure 4-U).

2. Touch the PRINT button.

3. Select the print period from the list.

Figure 4-V

Viewing Statistics

The system records and stores statistical data related to the number of runs and cassettes processed. This information is retrieved and viewed using the STATISTICS function. The system stores statistical information for the prior one-year period.

Statistical information can be a useful as a managerial tool to aid in evaluating operator activity, or in determining workloads for hospitals/clinics from which specimens were received for processing.

Statistics can be viewed for a selected daily, weekly, or

monthly period.

To access statistics:

1. From the UTILITIES screen, touch the STATISTICS

button.

• The STATISTICS PERIOD SELECTION screen

displays (Figure 4-V).

Revised 10/02/2012 4.15

Page 48

OPERATING INSTRUCTIONS

2. Select the period for which to view statistics, either

DAILY (for the prior seven days), WEEKLY (for the prior 7 weeks), or MONTHLY (for the prior 24 months).

• The screen refreshes to display the selected

DAILY STATISTICS (Figure 4-W), WEEKLY STATISTICS (Figure 4-X) or MONTHLY STATISTICS (Figure 4-Y) screen.

Figure 4-Y

To view statistics:

Figure 4-W

Figure 4-X

• The STATISTICS screen is comprised of a series

of data lines; one for each instrument operator (ADMIN 1 THRU 4, OPERATOR 1 thru 20) when viewing by OPERATOR, or for each user-defined item currently defined in the USER DEFINED FILE (see Configuring System Settings on page

3.2 for details) when viewing by location.

• The STATISTICS screen provides the following

information:

4.16 Revised 10/02/2012

Page 49

SHOWN ON REPORT

ITEM DEFINITION

PERIOD

MONTH

OPERATOR The operator with whom the statistics are associated. (The OPERATOR field is

User Defined File (“LOCATION” in this example)

DAYS

NUMBER OF RUNS

NUMBER OF CASSETTES

AVERAGE CASSETTES/RUN

AVERAGE CASSETTES/DAY

AVERAGE RUNS/DAY

The calendar date and day or week for which statistics are displayed. X X

The month and year for which statistics are displayed. X

shown only when viewing statistics by operator.)

The location with which the statistics are associated. (The LOCATION field is shown only when viewing statistics by location.)

The number of days included in the report period. X X

The number of processing runs initiated by the associated operator (when viewing by OPERATOR) or for the associated location (when viewing by LOCATION) for the currently selected period.

The total number of cassettes in all processing runs initiated by the associated operator (when viewing by OPERATOR) or for the associated location (when viewing by LOCATION) for the currently selected period.

The average number of cassettes-per-run processed by the associated operator (when viewing by OPERATOR) or for the associated location (when viewing by LOCATION) for the currently selected period.

The average number of cassettes-per-day processed by the associated operator (when viewing by OPERATOR) or for the associated location (when viewing by LOCATION) for the currently selected period.

The average number of runs-per-day processed by the associated operator (when viewing by OPERATOR) or for the associated location (when viewing by LOCATION) for the currently selected period.

• The STATISTICS screen initially displays statis-

tics for the current period (day, week, or month, as appropriate), by operator. To view statistics by location (in this example), touch the LOCATION button; the screen refreshes to display statistics for the current period, by location. Touch the OPERATOR button to return to the previous display.

NOTE: If the USER DEFINED FILE is not enabled (see Configuring System Settings on page 3.2 for details), the LOCATION option for viewing statistics will not be available.

• Use the scrollbar to view the entire statistics re-

port.

• To view statistics for another period, select the

desired period from the PERIOD (for DAILY or WEEKLY statistics) or MONTH (for MONTHLY

To print statistics:

NOTE: The PRINT option allows users to export a file to a

USB memory stick.

• FILE OUTPUT-exports a CSV file to a USB

memory stick

• PRINT-exports a PDF file to a USB memory stick

1. From the UTILITIES screen, touch the STATISTICS

button.

• The STATISTICS PERIOD SELECTION screen

displays (Figure 4-V).

2. Select the period for which to print statistics, either

DAILY, WEEKLY, or MONTHLY.

• The screen refreshes to display the selected

DAILY STATISTICS (Figure 4-W), WEEKLY STATISTICS (Figure 4-X) or MONTHLY STATISTICS (Figure 4-Y) screen.

statistics) drop-down menu.

• Touch the EXIT button to return to the UTILITIES

screen.

DAILY WEEKLY MONTHLY

X X X

X X

Revised 10/02/2012 4.17

Page 50

OPERATING INSTRUCTIONS

3. If necessary, use the PERIOD (for DAILY or WEEKLY

statistics) or MONTH (for MONTHLY statistics) dropdown menu to select the desired report period.

4. Touch the PRINT button to export data to a USB

stick.

Viewing the Error Log

The instrument maintains a log of errors that occur in monitored systems, subsystems or processes. This information serves as an aid in diagnosing equipment malfunctions, and in determining whether service is required.

To access the error log:

1. From the UTILITIES screen, touch the ERROR LOG

button.

• The ERROR LOG screen displays (Figure 4-Z).

Figure 4-Z

DATE & TIME

RUN

OPERATOR

The date and time at which the associated error was logged.

The identification number for the run that was in process when the associated error occurred. If the associated error occurred while the instrument was idle, this field is blank.

The name of the operator (ADMIN 1 THRU 4, OPERATOR 1 THRU 20) logged into the instrument when the associated error occurred. If the associated error occurred while no operator was logged in, this field is blank.

1. Use the scrollbar to scroll through the entire log.

2. Touch the EXIT button to return to the UTILITIES

screen.

To print the error log:

NOTE: The PRINT option allows users to export a file to a

USB memory stick.

• FILE OUTPUT-exports a CSV file to a USB

memory stick

• PRINT-exports a PDF file to a USB memory stick

1. From the UTILITIES screen, touch the ERROR LOG

button.

• The ERROR LOG screen displays (Figure 4-Z).

2. Touch the PRINT button.

To view the error log:

• The ERROR LOG screen is comprised of a se-

ries of data lines. There is one for each error that occurred in a monitored system, subsystem, or process.

• The ERROR LOG provides the following infor-

mation:

4.18 Revised 10/02/2012

Page 51

RECOVERY PROCESS

Overview

This section describes the recovery process for any operation that is suspended due to an error condition. If an error occurs during processing, the UTILITIES SCREEN provides a means of initiating the recovery procedure detailed in this section. In addition, it enables the operator to abort and restart any baskets that may have been suspended in Retorts 3 or 4. See “Section 8, Trouble- shooting” for specific troubleshooting procedures for a given error.

It is important to note that not all conditions causing an error are immediately recoverable. Some error conditions require a service technician to diagnose the problem and may require service attention. In this case, please contact the Sakura Technical Support Department at 800-7258723, option 2, (U.S. customers only), or the nearest authorized Sakura instrument distributor or representative.

Section 5

mediately recover, the error is cleared and the Xpress x120 process resumes where it left off.

NOTE: If the error that occurred is such that it prevents the system from resuming processing, it may be necessary to shutdown the instrument and provide service attention.

• If the ABORT button is pressed, a confirmation

screen displays (Figure 5-B). Press the YES button to continue with the abort process; press the

NO button to cancel the abort.

Detecting an Error Condition

When the instrument has detected an error during processing, a message window displays automatically. Write this message down. Then note the time left for the basket(s) in Retorts 3 and/or 4 for reference during recovery process setup. The window presents two options from which to choose, RESUME or ABORT (Figure 5-A).

Figure 5-A

Figure 5-B

• If the NO button is pressed, the system returns to

the prior display (Figure 5-A).

• If the RESUME button is pressed, and the error

is a condition from which the instrument can im-

Revised 10/02/2012 5.1

Page 52

RECOVERY PROCESS

• If the YES button is pressed, an advisory mes-

sage displays (Figure 5-C). All baskets must be removed from the system, and one of two options, GO TO STANDBY or SHUTDOWN can be selected.

These specimens can be reprocessed by placing them back into Retort 1 without compromising specimen integrity.

NOTE: If the Tissue-Tek Xpress x120 will be down for longer than 1 hour, place the tissue specimens in Molecular Fixative until instrument is operational. Preprocessing does not have to be repeated prior to reprocessing. If Molecular Fixative is not available place the tissue specimen in 10% NBF. Once the instrument is operational the preprocessing steps must be repeated prior to reprocessing.

To reprocess specimens starting in Retort 3 or 4:

1. From the UTILITIES screen, touch the PROCESS

RECOVERY button.

NOTE: The PROCESS RECOVERY button is enabled

only during the WARMING UP SYSTEM cycle.

• The PROCESS RECOVERY screen displays

(Figure 5-D).

Figure 5-C

• If the SHUTDOWN button is pressed, the system

will shut down. The main power switch can also be turned off if it appears that the instrument will require service.

• If the STANDBY button is pressed, the instru-

ment will revert to the standby mode and the WARMING UP SCREEN will display. The warming up screen ensures that the reagents are at the proper temperature to continue processing. It is not possible to override this procedure. Once the warming up process is completed, the instrument will go into the STANDBY mode and is again ready for processing.

Starting a Processing Run in Retort 3 or 4

It may be necessary to reprocess a specimen or group of specimens beginning in Retort 3 or 4 due to an error condition that suspended processing, or because of a technical processing issue.

NOTE: There are no special recovery methods for those specimens that may have been suspended in Retorts 1 or 2.

Figure 5-D

• The PROCESS RECOVERY provides the follow-

ing information/functions specific to process recovery:

5.2 Revised 10/02/2012

Page 53

PROCESS TIME entry dialog.

TIME TO READY

REAGENT 3 AND 4 READY

Pull down list

3 (Retort 3)

4 (Retort 4)

STOP

2. Once the reagents for Retorts 3 and 4 are at proper

temperature (the button text changes from red to black), and the Retorts are filled, touch the 3 (Retort

3) or 4 (Retort 4) button, as appropriate.

• The lid for the selected Retort opens, and the

PROCESS TIME dialog displays (Figure 5-E). The Retort for which process time is being set is shown in the upper left corner of the dialog.

Shows the time remaining until the reagents for Retorts 3 and 4 are completely melted. If the instrument was shut down following an abort, 4:00 hours will be displayed (this is the amount of time required to completely melt the reagents).

If the regents for Retorts 3 and 4 have completely melted, but the TIME TO READY timer has not expired, pressing the REAGENT 3 AND 4 READY button will override the timer and allow processing to begin immediately.

NOTE: Be certain that the reagents for Retorts 3 and 4 are completely melted before pressing the REAGENT 3 AND 4 READY button.

To select the desired program from pull down list. The process recovery program is made from this selected program.

Opens the lid for Retort 3 and displays the PROCESS TIME entry dialog.

Opens the lid for Retort 4 and displays the

Aborts the process recovery operation. The system returns to warm-up mode, then reverts to normal operation.

Figure 5-E

3. Place the basket to be processed in the Retort.

4. Use the keypad on the PROCESS TIME dialog to set

the amount of time for which processing will occur (the amount of processing time that remained when processing was aborted). Touch the ENTER key to begin processing. The Retort lid closes automatically.

NOTE: Reprocessing can be cancelled by pressing the CANCEL key. When the CANCEL key is pressed, the lid

for the corresponding Retort closes.

5. Repeat steps 2 through 4, if needed, to set process

recovery time for the remaining Retorts.

When process time for Retort 3 is completed, the basket is transferred to the Retort 4 for the programmed time. If a basket is currently in Retort 4, and the process time has not completed, the basket in Retort 3 will remain until processing for the basket in Retort 4 has completed.

When reprocessing is complete, the basket is transferred to the Unloading Station, and the system alerts the operator with an “End of Process” sound. The system performs a self check then enters into warm-up mode followed by normal operation mode.

Revised 10/02/2012 5.3

Page 54

RECOVERY PROCESS

5.4 Revised 10/02/2012

Page 55

Product Code

4295 4785

4786 4791

4792

4793

4800

4801

4802

4848 Grossing Wells, Left Handed

7730

7115

71 7120

Product Code

1550

4803

4804

4807 Grossing Fork (2.5mm)

4814

7103 7106

7107

7108

7109

7190

CONSUMABLES AND ACCESSORIES

Section 6

Consumable Materials

Description

Neutra-Pads (100/pk)

Trimming Knife Blades, 130mm

(50/pk)*

Trimming Knife Handle*

Scalpel Handle*

Scalpel Blades, #61 (20/pk)*

Scalpel Blades, #62 (20/pk)*

Grossing Board Kit

• Grossing Board

• Instruction Sheet

• Tampers (2 pcs)

• Gauge Set (4 pcs)

Grossing Board, Large

• Grossing Board

• Instruction Sheet

• Tampers (2 pcs)

• Gauge Set (4 pcs)

Grossing Wells

• Grossing Wells

• Instruction Sheet

• Tampers (2 pcs)

• Gauge Set (4 pcs)

Standard Accessory Items

Description

Paraffin Scraper

Grossing Fork (1.5mm)

Grossing Fork (2.0mm)

Grossing Fork Cleaning Brushes

(10/pk)

Basket w/ Handle, and lid,

40-Cassette (8 pcs)

Tray Liners (100/pk)

Fume Filter (2/pk)

Loading Station Container w/ Lid

• Grossing Wells

• Instruction Sheet

• Tampers (2 pcs)

• Gauge Set (4 pcs)

Reagent Set, (set of 4)

Pre-Processing Solution

17 Pre-Processing Fixative

Molecular Fixative(4 x 3.8L)

(4 x 3.8L)

Revised 10/02/2012 6.1

Basket Transportation Tray

Container Kit

*Not applicable to Model 7721

Page 56

CONSUMABLES AND ACCESSORIES

Product Code Description

O71

F60

0004389

Product Code

7006 7007

7139

7145

AI8

Maintenance & Service Items

-169-01 Drip Tray

-355-00 Reagent Bottle Tray

-01-0102 Retort Cleaning Pipette

-692-00 Retort Mesh Filter Removal Tool

-697-01 Sight Tube Cleaning Brush

-491-00 Spill Tray

Accessory Items for Compatibility with the Tissue-Tek® AutoTEC® Embedding System

Description

20-Cassette Tissue-Tek®

Tissue-Tek® AutoTEC® Magazine

Uninterruptible Power Supply (UPS)

Uninterruptible Power Supply, Extended Use (UPS)

-IF-001 Service Manual

Where to Call to Order Consumables and Accessories

If located within the United States, contact the Order Management Department of Sakura Finetek U.S.A, Inc., or by calling toll-free: 1-800-725-8723. Alternately, or in countries other than the United States, contact the nearest authorized Sakura distributor.

AutoTEC Includes 4 adapters, and 4 lids.

Handles (6/case)

Magazines (4/case)

-153-00 Unloading Station Container

-01 Operating Manual

6.2 Revised 10/02/2012

Page 57

CARE OF THE INSTRUMENT

Section 7

General Information

This section provides information on how to care for and maintain the Tissue-Tek must be maintained correctly to ensure proper operation.

Read this section carefully before attempting to perform maintenance. Follow all instructions carefully.

Proper periodic maintenance of the Tissue-Tek Xpress x120 is essential in maintaining the system in operational condition. Recommended periodic maintenance procedures are listed below along with the suggested frequency of performance. Maintenance procedures with a recommended frequency of “On Condition” should be performed whenever visual and/or functional inspection indicates the need.

NOTE: Depending on system use, it may be necessary to perform periodic maintenance procedures on a more frequent basis than recommended.

NOTE: A routine maintenance checklist can be found on the last page of Section 7.

PERIODIC MAINTENANCE

MAINTENANCE ACTION FREQUENCY

Clean Baskets or Magazines On condition

Clean Overflow Bottle On condition

Replace Pre-Processing Solution Loading Station

Replace Reagents On condition

Replace Paraffin On condition

Replace Drip Tray Liner Daily

Perform Exterior Cleaning Weekly

Perform Retort Cleaning Weekly

Clean Retort Mesh Filters Weekly

Clean Paraffin Oven Mesh Filters Weekly

Clean Retort Sight Tubes Weekly

Clean Preheating Chamber Sight Tubes Weekly

Replace Fume Control System Activated Carbon Cartridge

Xpress® x120. The system

(before each use)

On condition (0-24 hours)

Monthly

On Condition Maintenance

Basket / Magazine Cleaning

CAUTION: Using baskets or magazines with paraffin residue will cause clogging of the reagent transfer line and will result in instrument malfunction and improper processing of specimens.

A clean basket or magazine set MUST be used for

each processing run.

Cleaning of Processing Baskets and Magazines

A minimal amount of paraffin remains on Tissue-Tek Xpress x120 baskets following immersion in Retorts #3 and #4. The paraffin must be removed from the surface of the basket, basket handle, and lid prior to reuse.

If the AutoTEC 20-cassette magazines are being used on the instrument, the magazine, lid, and adapter must also be free from paraffin.

Cleaning Method #1 for Tissue-Tek Xpress x120 Processing Baskets and Magazines

The use of an automatic dishwasher with water temperature set on Hot and the use of a detergent is the recommended cleaning method. The amount of paraffin that must be removed from the processing basket(s) is minimal and should not contribute to clogging of the laboratory drain pipes.

WARNING: THE PRESENCE OF WHITE, CHALKY RESIDUE INDICATES THAT PARAFFIN REMAINS ON THE SURFACE OF THE BASKET WHICH COULD CLOG THE TISSUE-TEK XPRESS

Materials and Supplies:

• Recommended dishwasher soap (amount rec-

ommended by manufacturer)- Electrasol

Procedure:

Water temperature for washing basket must be HOT, at least 100°C or 212°F. It is recommended that hot water also be used to rinse the baskets after the hot soapy water wash.

X120 DRAIN FILTER.

Gelpac

Revised 10/02/2012 7.1

Page 58

CARE OF THE INSTRUMENT

1. Place basket(s) in to the dishwasher and place a pre-

measured amount of detergent, (1 Gelpac) or the amount recommended by the manufacturer, into the dishwasher.

2. Check that the cycle is set for normal dishwashing

(water temperature setting – HOT 100°C (212°F)).

3. Start the dishwasher.

4. The cycle time will depend on the setting selections

available on the dishwasher.

5. Remove the baskets from the dishwasher at the

completion of the dry cycle and inspect for the presence of paraffin on the surface of the basket and handle.

6. If the baskets are dry and free of paraffin, they are

ready for use.

Cleaning Method #2 for Tissue-Tek Xpress x120 Processing Baskets and Magazines

If an automatic dishwasher is not available for use in the laboratory, Tissue-Tek Xpress x120 processing baskets, magazines, cover, and handle may be cleaned by the following method, which requires the use of hot soapy water.

Materials and Supplies:

• Hot plate

• Appropriate sized metal container (leak proof)

• Detergent

• Water

Procedure:

1. Set the hot plate temperature to High or Hot.

2. Using a leak-proof metal container, fill with tap water,

and add detergent.

3. Allow the water and soap solution to heat up near

boiling point.

4. Place empty processing baskets/magazines and

handles in the container and allow to boil for at least five minutes.

5. Rinse the baskets/magazines with two changes of hot

water, then allow the baskets to air dry completely prior to reuse.

6. Check each basket/magazine for residual paraffin. If

the baskets are clean, they are ready for use.

7. Discard the soapy hot water solution down the drain.

Rinse the container with a second hot Discard soapy water down the drain.

Cleaning Method #3 for Tissue-Tek Xpress x120 Processing Baskets and Magazines

Materials and Supplies:

• 1 metal Xylene-resistant container

• Xylene or Xylene substitute

• Absolute alcohol

• Detergent

• Hot water

Procedure:

1. Fill a Xylene-resistant container with solvent (Xylene

or Xylene substitute).

2. Place empty processing baskets/magazines and

handles in the container.

3. Allow the baskets/magazines to remain in the solvent

container until the paraffin coating the surface of the baskets/magazines has been removed. The length of time required to remove any residual paraffin depends on the length of time the baskets/magazines were allowed to cool prior to cleaning. Agitating the baskets/magazines while immersed in the solvent will shorten the cleaning time required.

4. Remove the baskets/magazines from the solvent and

place in a container containing absolute alcohol, for a minimum of 30 minutes.

5. Rinse the baskets/magazines in hot water containing

detergent.

6. Rinse the baskets/magazines with two changes of hot

water, then allow the baskets/magazines to air dry completely prior to reuse.

7. Check each basket/magazine for residual paraffin. If

the baskets/magazines are clean and dry, they are ready for use.

water rinse.

7.2 Revised 10/02/2012

Page 59

Overflow Bottle Cleaning

The overflow bottles associated with Retort #3 and #4 serve as overflow receptacles in the event excess reagent (paraffin) is pumped into the associated retort. The overflow bottles should be cleaned as needed to remove any accumulated paraffin.

WARNING: THE OVERFLOW BOTTLES MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

To clean the overflow bottles:

1. Open the Overflow Bottles Access Door (Figure 7-A).

3. Discard accumulated paraffin in the overflow bottles

in accordance with local regulations for biohazardous waste.

4. Clean any paraffin residue in overflow bottles using

hot, soapy water, then rinse and wipe dry.

NOTE: The overflow bottles are labeled “#3” and “#4” to ensure reinstallation in the correct locations in the overflow bottle cabinet.

5. Reinstall the overflow bottles in the overflow bottle

cabinet. Be sure to match the labels on the overflow bottles with the labels on the overflow bottle cabinet to ensure installation in the proper locations.

6. Tighten each overflow bottle by turning to the right.

7. Close the Overflow Bottle Access Door.

Figure 7-A

2. Loosen each overflow bottle by turning to the left, and

remove the overflow bottles from the overflow bottle cabinet (Figure 7-B).

Figure 7-B

Pre-Processing Solution Replacement

Onboard Pre-Processing Solution must be replaced on condition (after a specified number of hours) to ensure proper preprocessing. The instrument con be configured to count the number of hours the solution has been in the instrument to aid in determining when to replace the PreProcessing Solution (See “System Operation”, page 4.5).

NOTE: Depending on the types of tissues processed the Pre-Processing Solution should be replaced every 3 hours.

To replace the Pre-Processing Solution:

WARNING: THE PREPROCESSING CONTAINER MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF THE CONTENTS IN ACCORDENCE WITH LOCAL REGULATIONS.

1. Open the Loading Station Door.

2. Remove the Loading Station Container.

3. Discard the Pre-Processing Solution per local

regulations.

4. Wipe the inside of the loading station container with

gauze.

5. Fill the Loading Station Container with 1.2L of Pre-

Processing Solution.

6. Place the Loading Station Container inside the

instrument.

7. Close the Loading Station Door.

Revised 10/02/2012 7.3

Page 60

CARE OF THE INSTRUMENT

Reagent Replacement

Reagent must be replaced periodically (after a specified number of runs or cassettes have been processed, or in the event an insufficient amount of reagent is available for processing) to ensure proper processing of tissue specimens. The instrument can be configured to count the number of cassettes processed, or the number of runs processed, as an aid in determining when to replace the reagents (see “Configuring System Settings” on page 3.2 for details). The “run” or “cassette” count is shown in the lower window of the WARMING UP SYSTEM, MANUAL START and AUTO START screens.

NOTE: Depending on the types of tissues processed and the hours of operation, the four-retort reagents set should be replaced after processing up to 1,500 specimens, up to about every 37 runs, or up to every 3 days, whichever comes first.

Following reagent replacement, the reagent counter status must be cleared to ensure proper tracking of the number of processed runs for the fresh reagents (see “Clearing the Reagent Counter” on page 7.7 for details).

CAUTION: To ensure proper processing of tissue specimens, reagent for Retorts #1 and #2, and paraffin for Retorts #3 and #4 MUST be replaced at the same time.

NOTE: Refer to “Section 9, Service and Replacement

Parts”, for information on obtaining replacement reagents.

Figure 7-C

NOTE: The instrument utilizes a

two-position locking lever to couple the reagent containers to the reagent supply system for Retorts #1 and #2.

3. Press each reagent container

locking lever down to the “RELEASE” (lower) position, then allow the lever to return to the “UNLOCKED” (upper) position, uncoupling the reagent containers (Figure 7-D).

Retorts #1 and #2 Reagent Replacement

NOTE: Each reagent container is equipped with a two-

piece cap/connector. The upper cap is used during shipment and storage of the container. The lower cap facilitates connection of the container to the Tissue-Tek Xpress x120 system.

WARNING: THE REAGENT CONTAINERS MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

To replace Retorts #1 and #2 reagents:

1. Perform a system shutdown.

2. Open Retort #1/#2 Reagent Cabinet Access Door

(Figure 7-C).

7.4 Revised 10/02/2012

4. Remove the reagent containers from the reagent

cabinet.

5. Invert the new reagent bottles 4-5 times to gently mix

the solution, prior to placing on the instrument.

Figure 7-D

Page 61

NOTE: Solely shaking the reagent bottle will not thoroughly mix the solution. The bottle must be inverted.

6. Remove the upper caps from the new reagent

containers, and install the caps on the used reagent containers. Discard the used reagent containers in accordance with local regulations for biohazardous waste.

7. Remove the foil seal from each reagent container.

8. Place the new reagent containers in the reagent

cabinet in the appropriate positions.

9. Press down on each reagent container locking lever

until it engages the “LOCKED” position, coupling the reagent containers with the reagent supply system (Figure 7-E).

To replace paraffin:

1. Perform a system shutdown.

2. Open the Paraffin Oven Access Door (Figure 7-F).

Figure 7-F

Figure 7-E

10. Close Retort #1/#2 Reagent Cabinet Access Door.

Retort #3 and #4 Paraffin Replacement

NOTE: Retain the shipping materials to drain used

paraffin.

WARNING: DISPOSE OF USED PARAFFIN IN ACCORDANCE WITH LOCAL REGULATIONS FOR BIOHAZARDOUS WASTE.

3. Remove the drip pan from the paraffin oven (Figure 7-

G). If necessary, remove hardened paraffin residue from the drip pan using the paraffin scraper (see “Section 6, Consumables and Accessories” for details). Replace the drip pan on the paraffin oven.

Figure 7-G

4. Press in on the paraffin oven to unlatch, then slowly

slide the oven out of the cabinet.

Revised 10/02/2012 7.5

Page 62

CARE OF THE INSTRUMENT

5. Using the shipping materials retained after the

previous paraffin replacement, line the cardboard shipping carton with the plastic bags. Place the lined cartons under the drain port for the Retort #3 paraffin oven (Figure 7-H).

6. Rotate the left drain control knob for Retort #3 paraffin

oven back, until the knob is vertical (Figure 7-I), opening the drain valve. Melted paraffin will begin to drain from the paraffin oven

paraffin in accordance with local regulations for biohazardous waste.

10. Turn the locking knob on the lid of the Retort #3

paraffin oven clockwise, then lift the lid to open (Figure 7-J).

Figure 7-H

Figure 7-I

7. After the melted paraffin has drained completely from

the paraffin oven, rotate the drain control knob to close the drain valve.

8. Repeat steps 5 and 6 for Retort #4 paraffin oven

(right drain control knob).

9. Seal the plastic bags securely. Allow the used paraffin

to harden, then seal the containers. Discard the used

Figure 7-J

11. Open the plastic shipping bag, and dispense the

entire contents into the paraffin oven (Figure 7-K), then close the oven lid.

Figure 7-K

12. Repeat steps 9 through 11 for Retort #4 paraffin oven.

NOTE: Be sure to retain the paraffin shipping cartons and plastic bags for use during the next paraffin replacement.

13. Slowly push the paraffin oven back into the cabinet

until the oven latches into place.

14. Close the Paraffin Oven Access Door.

NOTE: Following paraffin replacement, the instrument may require up to four hours to melt the paraffin and exit the WARMING UP SYSTEM cycle.

7.6 Revised 10/02/2012

Page 63

Unloading Station Paraffin Replacement

If desired, paraffin can be used in the Unloading Station retort container to ensure tissues are immersed in molten paraffin when processing is complete. Paraffin replacement should be performed at the same time the four-retort reagent set is replaced.

To replace paraffin:

1. Open the Unloading Station Access Door (Figure 7-L).

NOTE: The user must be logged on to the system as an Administrator in order to clear the reagent counter (see

NOTE: The user must be logged on to the system as an Administrator in order to clear the reagent counter (see “Logging On” on page 4.4 for details).

1. From the UTILITIES screen, touch the REAGENT

COUNT CLEAR button.

• A confirmation dialog displays (Figure 7-M).

2. Touch the OK button to clear the reagent counter.

(Touch the CANCEL button to close the confirmation dialog without clearing the reagent counter.)

• The confirmation dialog closes, and the reagent

counter is reset to “0”.

Figure 7-L

2. Grasp the container handle and lift the container out

of the Unloading Station retort.

3. Pour the used paraffin into a suitable waste container.

4. Fill the container with fresh molten paraffin, and return

the container to the Unloading Station retort.

5. Close the Unloading Station Access Door.

Clearing the Reagent Counter

The instrument can be configured to count of the number of cassettes processed, or the number of runs processed, as an aid in determining when to replace the reagents (see “Configuring System Settings” on page 3.2 for details). The “run” or “cassette” count is shown in the lower window of the WARMING UP SYSTEM, MANUAL START and AUTO START screens.

When reagent is replaced, the reagent counter must be cleared to maintain an accurate count for the next reagent replacement cycle.

To clear the reagent counter:

Figure 7-M

Daily Maintenance

Drip Tray Liner Replacement

NOTE: Depending on the number of runs performed on a given day, more frequent replacement of the drip tray liner may be necessary.

Replace the soiled drip tray liner from the transferring arm drip pan and the transport tray with a fresh tray liner daily or as needed.

If necessary, remove hardened paraffin residue using the paraffin scraper (see “Section 6, Consumables and Accessories” for details).

WARNING: MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

Revised 10/02/2012 7.7

Page 64

CARE OF THE INSTRUMENT

NOTE: Refer to “Section 6, Consumables and Accesso-

ries”, for information on obtaining drip tray liners.

Weekly Maintenance

Exterior Cleaning

Keep the exterior of the Tissue-Tek Xpress x120 cabinet free of dust and clutter. Generally, wiping with a clean cloth moistened with water is all that is needed to keep the cabinet dust free. Do not use solvents of any kind on the front of the control panel. To disinfect the keypad, wipe with 70% ~ 80% ethanol or isopropanol, and allow to air dry. The acrylic doors may be cleaned with a glass cleaner and soft cloth.

The retort mesh filters aid in ensuring that any debris generated during processing does not enter reagent containers or the paraffin ovens. If excessive debris accumulates, the filling and draining processes for the retorts may be affected.

To ensure proper filling and draining of all retorts, clean the retort mesh filters weekly.

To clean the retort mesh filters:

1. Open the Retort Access Door (Figure 7-N). The Access

Door supports will retain the door in the open position.

Retort Cleaning

WARNING: MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

NOTE: Open the retort lids manually as necessary to

facilitate cleaning operations. Be sure to close the lids when finished cleaning.

Clean the inside of Retorts #1 and #2 and the retort flanges with a lint-free cloth moistened with isopropyl alcohol, then wipe dry. After cleaning, manually close the retort lids.

WARNING: RETORTS #3, #4, AND UNLOADING RETORT HAVE HOT SURFACES.

Clean the inside of Retorts #3, #4, unloading retort, and the retort flanges with a lint-free cloth moistened with a xylene substitute, then wipe dry. After cleaning, manually close the retort lids.

Use the paraffin scraper (see “Section 6, Consumables and Accessories” for details) from the retort shelf inside the instrument. Clean excess paraffin residue from the retort shelf inside the instrument with a lint-free cloth moistened with a xylene substitute, then wipe dry.

Figure 7-N

NOTE: Open the retort lids manually as necessary to

facilitate mesh filter removal for cleaning.

2. Insert the Retort Mesh Filter Removal Tool (see

“Section 6, Consumables and Accessories” for details) into the retort and engage the hub in the center of the filter. Turn the removal tool counterclockwise to unlock the mesh filter, then pull the filter free from the retort (Figure 7-O).

Retort Mesh Filter Cleaning

WARNING: MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

7.8 Revised 10/02/2012

Figure 7-O

Page 65

CAUTION: Exercise care to avoid damaging the mesh filter during cleaning. Tears in the mesh may allow debris to enter the reagent containers or paraffin ovens, and result in improper processing of tissue specimens.

3. Clean Retorts #1 and #2 mesh filters using a soft-

bristle brush and isopropyl alcohol. Ensure that the filters are completely free of debris. Allow the filters to air dry.

4. Clean Retorts #3 and #4 mesh filters using a soft-

bristle brush and hot soapy water. Ensure that the filters are completely free of debris. Rinse the filters and allow to air dry.

5. Use the Retort Mesh Filter Removal Tool to engage

the hub in the center of the mesh filter. Insert the filter into the appropriate retort, then turn the removal tool clockwise to lock the filter in place.

6. After installation, manually close the retort lids.

7. Close the Retort Access Door.

Paraffin Oven Mesh Filter Cleaning

The paraffin mesh filters aid in ensuring that any debris generated during processing does not enter the paraffin ovens. If excessive debris accumulates, the filling and draining processes for Retorts #3 and #4 may be affected.

To ensure proper filling and draining of the retorts, clean the paraffin oven mesh filters weekly.

To clean the paraffin oven mesh filters:

1. Open the Paraffin Oven Access Door (Figure 7-P).

2. Press in on the paraffin oven to unlatch, then slowly

slide the oven out of the cabinet.

3. Turn the locking knob on the lid of Retort #3 paraffin

oven clockwise, then lift the lid to open (Figure 7-Q).

Figure 7-Q

4. Grasp the tab of the mesh filter, and pull up to remove

the filter from the paraffin oven.

CAUTION: Exercise care to avoid damaging the mesh filter during cleaning. Tears in the mesh may allow debris to enter the retorts and result in improper processing of tissue specimens.

5. Clean the filter using a soft-bristle brush and hot

soapy water. Ensure that the filter is completely free of debris. Rinse the filter and allow to air dry.

6. Hold the mesh filter by the tab, and replace the filter

in the paraffin oven. Close the oven lid.

7. Repeat steps 3 through 6 for Retort #4 paraffin oven

mesh filter.

8. When both filters have been cleaned, slowly push the

paraffin oven back into the cabinet until the oven latches into place.

9. Close the Paraffin Oven Access Door.

Figure 7-P

Revised 10/02/2012 7.9

Page 66

CARE OF THE INSTRUMENT

Remove

Retort Sight Tube Cleaning

Retort Sight Tubes should be cleaned weekly to ensure reagent in Retorts #1 and #2 is filled and maintained at the appropriate levels for proper processing of tissue specimens, and to guard against reagent overflow.

To clean the Retort Sight Tubes:

1. Open the Retort Access Door (Figure 7-R). The

Access Door supports will retain the door in the open position.

Figure 7-R

2. Remove sight tube screw (Figure 7-S)

remove debris from the wall of the sight tube (Figure 7-T).

Figure 7-T

NOTE: Debris removed from the sight tube walls during

cleaning will accumulate in the bottom of the sight tube. Be sure to use the retort cleaning pipette to extract and expel any accumulated debris.

4. Insert the retort cleaning pipette (see “Section 6,

Consumables and Accessories” for details) into the trap at the bottom of the sight tube. Draw out the remaining reagent.

5. Remove the pipette from the sight tube and discard

reagent.

6. Repeat steps 4 and 5 as needed to extract and expel

all debris from the sight tube.

7. Repeat steps 2 through 5 for Retort #2.

8. Manually close the retort lids.

9. Close the Retort Access Door.

this screw

NOTE: Open Retort #1 and #2 lids manually, as neces-

sary, to facilitate cleaning the retort sight tubes.

3. Insert the sight tube cleaning brush (see “Section 6,

Consumables and Accessories” for details) into the sight tube, and scrub up and down several times to

7.10 Revised 10/02/2012

Figure 7-S

Page 67

Preheating Chamber Sight Tube Cleaning

The Preheating Chamber sight tubes should be cleaned weekly to ensure reagent in Retorts #1 and #2 is filled and maintained at the appropriate levels for proper processing of tissue specimens, and to guard against reagent overflow.

WARNING: MAY CONTAIN BIOHAZARDOUS WASTE. DISPOSE OF CONTENTS IN ACCORDANCE WITH LOCAL REGULATIONS.

To clean the preheating chamber sight tubes:

CAUTION: Ensure the system shutdown has completed prior to opening the valve.

1. Open the preheating chamber access door on the

left-hand side of the instrument.

NOTE: Prior to opening the valves, place a small container under the valves to catch any reagent within the site tubes.

2. Turn the sight tube access valve for the Retort #1

preheating chamber counterclockwise to open the valve (Figure 7-U).

4. After cleaning, turn the sight tube access valve for

Retort #1 preheating chamber clockwise to close the valve.

5. Repeat steps 2 through 4 for the Retort #2 sight tube.

6. Close the preheating chamber access door.

Figure 7-V

Monthly Maintenance

Fume Control System Filter Replacement

WARNING: AN ACTIVATED CARBON FILTER MUST BE INSTALLED IN THE INSTRUMENT AT ALL TIMES TO ENSURE PROPER FILTERING OF FUMES GENERATED DURING PROCESSING.

The fume control system serves to reduce acetone emissions generated by the instrument to acceptable levels. To ensure proper filtering and fume control, replace

Figure 7-U

3. Insert the sight tube cleaning brush (see “Section 6,

Consumables and Accessories” for details) into the

sight tube, and scrub up and down several times to remove debris from the wall of the sight tube (Figure 7-V).

Revised 10/02/2012 7.11

the fume control system filter monthly.

To replace the fume control system activated carbon filter:

Page 68

CARE OF THE INSTRUMENT

1. Open the Fume Control System Access Door (Figure

7-W).

4. Slide the fume filter out of the instrument (Figure 7-Z).

Figure 7-W

2. Release the latch securing the fume filter access door

(Figure 7-X) and open the access door.

Figure 7-X

3. Unlock the latch securing the fume filter cover (Figure

7-Y) and lift the cover up.

5. Install a new fume filter in the instrument. Lower the

fume filter cover and secure the cover latch.

6. Close the fume filter access door and secure the door

latch (Figure 7-AA).

7. Close the Fume Control System Access Door.

Figure 7-Z

Figure 7-AA

Figure 7-Y

7.12 Revised 10/02/2012

Page 69

Daily Care Week 1

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace MF in load station

Lot#

Perform Exterior Cleaning

Perform Interior Cleaning

Replace Drip Tray Liner

Check Reagent Bottle

Check Overflow Bottle

Clean Cassette Baskets

Daily Care Week 2

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace MF in load station

Lot#

Perform Exterior Cleaning

Perform Interior Cleaning

Replace Drip Tray Liner

Check Reagent Bottle

Check Overflow Bottle

Clean Cassette Baskets

Daily Care Week 3

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace MF in load station

Lot#

Perform Exterior Cleaning

Perform Interior Cleaning

Replace Drip Tray Liner

Check Reagent Bottle

Check Overflow Bottle

Clean Cassette Baskets

Daily Care Week 4

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace MF in load station

Lot#

Perform Exterior Cleaning

Perform Interior Cleaning

Replace Drip Tray Liner

Check Reagent Bottle

Check Overflow Bottle

Clean Cassette Baskets

Daily Care Week 5

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace MF in load station

Lot#

Perform Exterior Cleaning

Perform Interior Cleaning

Replace Drip Tray Liner

Check Reagent Bottle

Check Overflow Bottle

Clean Cassette Baskets

Tissue-Tek® Xpress® x120 Tissue Processor

Routine Maintenance Check List, Daily

Proper periodic maintenance of the Tissue-Tek® Xpress® x120 Tissue Processor is essential in maintaining the system in operational condition. Recommended periodic maintenance procedures and frequencies of performance are listed below. Keeping a running log of all routine maintenance preformed

on the Tissue-Tek® Xpress® x120 Tissue Processor is advised. MONTH:__________________

Revised 10/02/2012 7.13

Page 70

Reagent Change Week 1

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace On Board Reagent Set

Lot#

Cassette Count

Clean Microwave Retort Mesh Filter

Clean Microwave Chamber Sight Tube

Clean Paraffin Retort

Clean Paraffin Retort Mesh Filter

Clean Paraffin Oven

Clean Paraffin Oven Mesh Filter

Reagent Change Week 2

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace On Board Reagent Set

Lot#

Cassette Count

Clean Microwave Retort Mesh Filter

Clean Microwave Chamber Sight Tube

Clean Paraffin Retort

Clean Paraffin Retort Mesh Filter

Clean Paraffin Oven

Reagent Change Week 3

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace On Board Reagent Set

Lot#

Cassette Count

Clean Microwave Retort Mesh Filter

Clean Microwave Chamber Sight Tube

Clean Paraffin Retort

Clean Paraffin Retort Mesh Filter

Clean Paraffin Oven

Reagent Change Week 4

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace On Board Reagent Set

Lot#

Cassette Count

Clean Microwave Retort Mesh Filter

Clean Microwave Chamber Sight Tube

Clean Paraffin Retort

Clean Paraffin Retort Mesh Filter

Clean Paraffin Oven

Reagent Change Week 5

Beginning Date___________

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Replace On Board Reagent Set

Lot#

Cassette Count

Clean Microwave Retort Mesh Filter

Clean Microwave Chamber Sight Tube

Clean Paraffin Retort

Clean Paraffin Retort Mesh Filter

Clean Paraffin Oven

Tissue-Tek® Xpress® x120 Tissue Processor

Routine Maintenance Check List, Weekly

MONTH:__________________

Replace Carbon Filter Date:______________________ Preheat Chamber Sight Tubes Date:__________________________

7.14 Revised 10/02/2012

Page 71

TROUBLESHOOTING

General Troubleshooting Procedures

CAUTION: All the processes are interrupted during an Error. Therefore, please remove all the baskets from the instrument as soon as possible and protect specimens when an error occurs. If specimens are left in the instrument for a prolonged period, detrimental effects could result.

CAUTION: If any of the Access Doors are open, the Transfer System would be disabled and the baskets will not be transferred. Keeping an access door open for a prolonged period could result in detrimental effects on specimens.

TROUBLESHOOTING CHART

PROBLEM PROBABLE CAUSE REMEDY

Power indicator is not illuminated.

Retorts #3 and #4 are not heated.

LCD display screen does not display when System Start Switch is pressed.

Retorts #3 and #4 have reached set temperature, but “warmingup” process does not proceed to the next step.

LCD screen turns on unexpectedly.

1. Line cord is not plugged. Power failure.

2. Main power switch (circuit breaker) is off.

3. UPS power switch is off.

4. UPS outputs “power failure” signal.

1. Line cord is not plugged. Power failure.

2. Main power switch (circuit breaker) is off.

3. UPS power switch is off.

4. UPS outputs “power failure” signal.

1. Line cord is not plugged. Power failure.

2. Main power switch (circuit breaker) is off.

3. UPS power switch is off.

4. UPS outputs “power failure” signal.

1. System is waiting until reagents #3 and #4 in paraffin oven

are completely melted.

1. Power failure occurred.

2. System is in “Auto Ready/Shutdown” mode.

3. “ON TIME” and “OFF TIME” are set for the day in

“READY/SHUTDOWN TIMES” screen.

Section 8

The following Troubleshooting Chart contains general problems that could occur during operation of the Tissue-

Xpress® x120 system. Probable causes and recom-

Tek mended remedies are included for each problem listed, to aid in diagnosis and correction.

If additional assistance is required concerning a Tissue-Tek Xpress x120 system problem, or if a problem cannot be corrected or is beyond the scope of this manual, contact the Sakura Finetek Technical Support Representative for information or assistance.

1. Make sure power is available at the power

source. Make sure the line cord is properly connected to the electrical power source.

2. Turn the main power switch ON

3. Turn the UPS power switch ON.

4. Contact Sakura Technical Support.

1. Make sure power is available at the power

source. Make sure the line cord is properly connected to the electrical power source.

2. Turn the main power switch ON

3. Turn the UPS power switch ON.

4. Contact Sakura Technical Support.

1. Make sure power is available at the power

source. Make sure the line cord is properly connected to the electrical power source.

2. Turn the main power switch ON

3. Turn the UPS power switch ON.

4. Contact Sakura Technical Support.

1. Ensure that reagents #3 and #4 in paraffin

oven are completely melted and that all paraffin in plumbing reach appropriate temperature; then press “REAGENTS 3 AND 4 READY” button.

1. No action is needed.

2. Change setting to “Manual Ready/Shutdown”

mode.

3. Change setting to “NOT IN USE”.

Revised 10/02/2012 8.1

Page 72

TROUBLESHOOTING

PROBLEM PROBABLE CAUSE REMEDY

Warm-up or shutdown does not begin according to “Auto Ready/Shutdown” setting.

Shutdown begins unexpectedly. 1. Instrument is in “Auto Ready/ Shutdown” mode.

1. Instrument is in “Manual Ready/Shutdown” mode.

2. “NOT IN USE” is set for the day in “READY / SHUTDOWN

TIMES” screen.

3. The day is specified as “holiday” in “DAYS OFF” screen.

4. Date setting is not correct.

5. “ON TIME” set for the day in “READY/SHUTDOWN

TIMES” screen is too late.

2. “OFF TIME” set for the day in “READY/SHUTDOWN

TIMES” screen is too early.

3. Date setting is not correct.

1. Change setting to “Auto Ready/Shutdown”

mode.

2. Set “ON TIME” and “OFF TIME”.

3. Cancel holiday setting.

4. Correct date setting.

5. Set earlier “ON TIME”.

1. Change setting to “Manual Ready/Shutdown” mode.

2. Set later “OFF TIME”.

3. Correct date setting.

Automatic warm-up operation ended approximately 30 minutes earlier than set time.

Shutdown does not begin according to Ready/Shutdown Times setting (with instrument in “Auto Ready/Shutdown” mode).

System started automatically and then shutdown began automatically after a time.

1. Since automatic warm-up begins one hour before “ON

TIME” (in consideration of various environmental temperatures), warm-up ends earlier than set time.

1. One or more baskets are currently being processed.

2. One or more baskets are unloading station.

3. Instrument was started manually following an automatic

shutdown (automatic shutdown will not begin until next “OFF TIME” occurs when the instrument has been started manually following automatic shutdown).

4. “OFF TIME” setting is not correct.

1. Power failure occurred. 1. No action is needed.

Monitored Errors

Certain components, operating parameters and system conditions are monitored while the system is powered on, and during operation, to ensure the instrument is in operational condition. When a monitored component or parameter falls outside the established limits or operating criteria, an alarm sounds continuously until the error is cleared, and an error number or warning message is shown on the Tissue-Tek Xpress x120 display. To cancel (turn off) the alarm, press the EXIT button on the warning message.

Each error that results in the display of an error number generates an entry in the system Error Log. The Error Log stores the 100 most recent errors, arranged by date, and provides a description of each error (see “Viewing the Error Log” on page 4.18 for details).

1. Use instrument as it is, or set later “ON

TIME”.

1. Continue processing; remove basket(s) from

unloading station when complete.

2. Remove basket(s) from unloading station.

3. Shut the system down manually.

4. Set correct “OFF TIME”.

8.2 Revised 10/02/2012

Page 73

SERVICE AND REPLACEMENT PARTS

Section 9

Service Information

When there is a Problem with the Instrument

When a problem occurs during operation of the Tissue-

Xpress® x120 instrument, refer to Section 8, Trouble-

Tek shooting, to determine the most likely cause of the malfunction and to obtain recommended corrective actions. (Avoid problems by carefully following the proper operation and maintenance procedures described in this manual). If the problem cannot be solved and an instrument failure is apparent, the Customer Support Department is available to assist.

Before calling for instrument service, please have model number, installation date, and warranty period ready for our Customer Support Representative. For convenience and reference, record this information in the blanks below.

Model Number ________________________________

Serial Number ________________________________

Replacement Accessory Items

Product Number Description

1550 Paraffin Scraper

4785 Trimming Knife Blades, 130mm (50/pk)

4786 Trimming Knife Handle

4791 Scalpel Handle

4792 Scalpel Blades, #61 (20/pk)

4793 Scalpel Blades, #62 (20/pk)

4800 Grossing Board Kit

4801 Grossing Board, Large

4802 Grossing Wells

4803 Grossing Fork (1.5mm)

4804 Grossing Fork (2.0mm)

4807 Grossing Fork (2.5mm)

7103 Basket with Handle, 40-Cassette

7106 Tray Liners (100/pk)

7107 Fume Filter (2/pk)

7108 Loading Station Container with Lid

7109 Basket Transportation Tray

Installation Date _______________________________

Warranty Period _______________________________

Where to Call for Service

If located within the United States, contact the Customer Support Department of Sakura Finetek U.S.A., Inc. by calling toll free:

1-800-725-8723

In countries other than the United States, contact

the nearest authorized Sakura instrument distributor or representative for service information and assistance.

Consumable Materials

Product Number Description

4295 Neutra-Pads (100/pk)

7115 Pre-Processing Solution (4 x 3.8L)

7117 Pre-Processing Fixative (4 x 3.8L)

7120 Molecular Fixative

7730 Reagent Set (set of 4)

Service Accessory Items

Product Number Description

O71-169-01 Drip Tray

O71-355-00 Reagent Bottle Tray

D9-01-0102 Retort Cleaning Pipette

O71-692-00 Retort Mesh Filter Removal Tool

O71-697-01 Sight Tube Cleaning Brush

O71-491-00 Spill Tray

F60-153-00 Unloading Station Container

0004389-01 Operating Manual

Revised 10/02/2012 9.1

Page 74

SERVICE AND REPLACEMENT PARTS

Optional Accessory Items

Product Number Description

7139 Uninterruptible Power Supply (UPS)

7145 Uninterruptible Power Supply,

Extended Use (UPS)

AI8-IF-001 Service Manual

Where to Order:

In the United States, the above Replacement Acces-

sory Items may be ordered directly from:

Order Management Sakura Finetek U.S.A., Inc. 1750 W. 214th Street Torrance, CA 90501 1-800-725-8723

Or contact the nearest authorized Tissue-Tek distributor or representative.

Outside of the United States, contact the nearest authorized Sakura instrument distributor.

9.2 Revised 10/02/2012

Page 75

TISSUE-TEK® XPRESS® X120

Appendix

RAPID TISSUE PROCESSOR APPLICATIONS MANUAL

Overview

Tissue Processing on the Tissue-

Xpress® x120 Rapid Tissue

Tek Processor

Tissue samples that will be processed on the Tissue-

Xpress® x120 Rapid Tissue Processor require proper

Tek preparation and handling to ensure acceptable results. Specimen preparation begins shortly after the specimen is excised from the patient. The tissue is sent to the pathology laboratory, either fresh or in an appropriate fixative, such as Molecular Fixative or Formalin. The Pathologist or Pathology Assistant grosses the tissue sample and places the desired selection in a cassette for processing. At the completion of the processing program, the tissue is embedded in paraffin, preparing it for microtomy and subsequent staining and coverslipping.

This Appendix provides guidelines and techniques related to the following critical areas:

• Preparation of appropriate-sized tissue samples for

Tissue-Tek Xpress x120 processing, and selection of the appropriate immersion program

• Use of Molecular Fixative and its effect on routine and

special staining and procedures

• Use of Pre-Processing Reagents

• Embedding practices for Tissue-Tek Xpress x120-

processed tissue

• Microtomy practices for Tissue-Tek Xpress x120-

processed tissue blocks

• Staining of Tissue-Tek Xpress x120-processed tissue

slides

• Microscopic evaluation of Tissue-Tek Xpress x120-

processed tissue slides

• Reprocessing of Tissue-Tek Xpress x120-processed

tissue

• Reagent replacement and frequency

• Do’s and don’ts

• Disposal of Tissue-Tek Xpress x120 processing

reagents

Revised 10/02/2012 A.1

Preparation for Processing

The Tissue-Tek Xpress x120 can be configured for operation using one of two immersion time settings for tissue processing based on the thickness of the grossed tissues: either 2 mm maximum or 3 mm maximum.

Use of Tissue-Tek Xpress x120 Pre-Processing Solution or Pre-Processing Fixative

Pre-Processing Solution is used to firm and precondition the tissue specimens prior to Tissue-Tek Xpress x120 processing. Some types of tissue (such as breast, skin, etc.) grossed at 2 mm may require a longer immersion time in the Pre-Processing Solution.

Pre-Processing Fixative is used for long term storage and transport or to precondition tissue specimens prior to Tissue-Tek Xpress x120 processing. Pre-Processing Fixative is more readily compatible with poorly formalinfixed tissue specimens. Pre-Processing Fixative is not compatible with all molecular pathology techniques, it is however compatible with IHC techniques.

Use a container capable of holding at least 500 mL of reagent. Change the Pre-Processing reagents every 3 hours. If excessive debris or cloudiness occurs, change more frequently.

Tissue Preparation for the 2 mm (15min/station) Standard Immersion Program

Tissue specimens of up to 2 mm in thickness are processed using the 2 mm (15 min/station) Standard immersion program. The total processing time, including robotic transfer of the basket between stations, is approximately 67 minutes. The 2 mm Standard program is appropriate for use only with tissue samples that are not larger than 2 mm in thickness. The length and width of the tissue should allow for space between the tissue and cassette walls.

Fixed tissues that cannot be initially trimmed to 2 mm thickness must be grossed to a thickness no greater than 3 mm, placed in a cassette, and immersed in a container filled with the Pre-Processing Solution for a minimum of 15

Page 76

APPLICATIONS MANUAL

minutes. Fatty tissue, lymphoreticular tissue and bloody tissue may require additional immersion time (30 – 60 minutes) in the Pre-Processing Solution prior to performing the final trimming of the specimen. Following the required immersion time in the Pre-Processing Solution, the cassettes are then removed from the solution, opened, and the tissue then trimmed to the final 2 mm in thickness. The tissue is then placed back in the cassette, and is immersed in 10% NBF for 1 hour.

CAUTION: Tissue Specimens are to be held in 10% NBF until they are ready to start the preprocessing step.

NOTE: It is recommended that tissue specimens are

immersed in Pre-Processing Solution for a minimum of 45 minutes or in Pre-Processing Fixative for a minimum of 30 minutes prior to being processed by the Tissue-Tek Xpress x120.

Tissue Preparation for the 3 mm (30min/station) Extended Immersion Program

The 3 mm Extended immersion program is used for processing of tissue specimens of up to 3 mm in thickness. The total processing time, including robotic transfer of the basket between stations, is approximately 127 minutes. The length and width of the tissue should allow for space between the tissue and cassette walls.

The tissue is trimmed to 3 mm maximum in thickness, placed in cassettes, and is immersed in 10% NBF for 3 hours.

NOTE: All tissue must be immersed in Pre-Processing Solution for a minimum of 15 minutes prior to being processed by the Tissue-Tek Xpress x120.

CAUTION: Tissue specimens are to be held in 10% NBF until they are ready to start the preprocessing step.

Access Permitted Icon displays on the Process Monitor

screen.

At the completion of the processing program, the basket containing the processed cassettes may be removed immediately. The processed cassettes are then transported to the embedding center. Each processing basket must be thoroughly cleaned before reuse (see “Cleaning of Processing Baskets” on page 7.1 for details).

Use of Tissue-Tek Molecular Fixative

Use of Molecular Fixative is mandatory for tissue specimens that require certain studies, such as DNA, RNA, and protein. It is recommended that specimens for RNA studies be placed into Molecular Fixative immediately upon excision from the patient. The use of Molecular Fixative:

• Stops any further degradation of RNA that normally

occurs

• Does not cause cross linking with proteins

• Preserves histomorphology

• Protects high quality DNA, RNA, and proteins at

ambient temperature

• Can be used to transport the specimen to the laboratory

• Can be used for tissue specimen storage

NOTE: Pre-Processing Fixative is not as compatible with all Molecular Pathology techniques (it is however compatible with IHC techniques, the same as Pre-Processing Solution).

Processing Tissue Specimens

CAUTION: The Loading Station retort should be filled with Preprocessing Solution to accelerate the dehydration process.

Additional processing baskets (with tissue samples) can be loaded into the Loading Station when the Loading Indicator lights steady “ON” and the Loading Station

A.2 Revised 10/02/2012

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Hematoxylin and Eosin (H&E) and Special Stains:

• Tinctorial staining is slightly more intense with

Molecular Fixative than with Formalin-fixed tissues.

• Tissue may stain more eosinophilic when using

Tissue-Tek Molecular Fixative, which may require decreasing the staining time in Eosin (approximately 40%).

• Molecular-fixed tissue and Formalin-fixed tissue

yields similar staining results for special stains.

DNA:

• Tissue treated with Molecular Fixative yields similar

results to enzyme digested DNA extracted from fresh tissue (frozen).

• Crossing Threshold for Molecular-fixed tissue is

comparable to DNA extracted from fresh tissue.

• Crossing Threshold measured after 24 hours yields

results similar to DNA from fresh tissue.

PROTEIN:

Immunohistochemistry:

• Some types of Molecular-fixed tissue may not require

Antigen Retrieval.

• Molecular Fixative does not cause cross-linking,

which occurs with Formalin.

• Increased intensity of IHC staining can be anticipated

with some types of antibodies when tissue is placed directly into Molecular Fixative.

• Tissue for Her-2 must be

with FDA approved protocols. Refer to the manufacturer’s operating protocol for specific instructions on how to fix the specimens.

fixed in Formalin to comply

RNA:

• Molecular fixative preserves RNA from degradation, if

tissue is placed directly into the solution immediately upon surgical excision.

• Finer nuclear detail can be expected with the use of

Molecular Fixative.

• Molecular fixed tissues yield amplification curves

similar to fresh specimens.

process tissue for RNA studies in Formalin or

Do not expose tissue for RNA studies to any items that have come in contact with Formalin. RNase-free conditions of paraffin embedded tissue will yield intact RNA comparable to fresh tissue. If the Tissue-Tek Xpress x120 has been used for processing Formalin-fixed tissue, the Tissue-Tek Xpress x120 must be cleaned prior to use for RNA study (see “Cleaning Instructions for RNA Tissue Processing” on page A.3 for details).

• Molecular fixed tissue yields gel electrophoresis

results similar to those seen from protein extracts from fresh tissue.

• Western Blot testing shows stronger distinct bands

when compared with Formalin-fixed material.

• Time interval between surgical excision and tissue

fixation in Molecular Fixative (usually 30 minutes), does not affect the quality of the extracted proteins.

Cleaning Instructions for RNA Tissue Processing

Description:

Processing of RNA tissue requires an RNase-free environment. If the Tissue-Tek Xpress x120 has been used for processing Formalin-fixed tissue, the Tissue-Tek Xpress x120 must be cleaned prior to use for RNA study. Failure to properly prepare the Tissue-Tek Xpress x120 prior to processing tissue specimens for RNA studies may cause the degradation of RNA.

Materials and Equipment Required:

• 0.1% diethylpyrocarbonate

• Sterile water

• Autoclave

• RNaseZap

Inc, TX, USA www.ambion.com)*

• Gloves

• Face mask

* RnaseZap

Wipes (may be purchased from Ambion,

is a registered trademark of Ambionm Inc.

Revised 10/02/2012 A.3

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APPLICATIONS MANUAL

Procedure:

WARNING: WEAR PROTECTIVE PERSONAL EQUIPMENT WHEN CLEANING THE TISSUE-TEK XPRESS X120 PRIOR TO PROCESSING TISSUES FOR RNA STUDIES. USE OF A FUME HOOD IS RECOMMENDED FOR PREPARATION OF THE DECONTAMINATION SOLUTION AND THE CLEANING OF SMALL INSTRUMENTS.

1. Rinse all baskets and small instruments that come in

contact with the tissue using 0.1% diethylpyrocarbonate dissolved in sterile water.

2. Leave items in the 0.1% diethylpyrocarbonate

solution overnight.

3. Autoclave the items in the solution for 1 hour.

4. Wipe all parts of the instrument that come in contact

with tissue using the RNAZap wipes.

5. Use gloves and a facemask when operating the

instrument.

Microtomy

Paraffin embedded Tissue-Tek Xpress x120 tissue can be sectioned on a Microtome. The tissue blocks usually do not require soaking. The blocks can be faced and allowed to cool face up on ice water for not more than 5 minutes prior to sectioning.

CAUTION: Avoid soaking of Tissue-Tek Xpress x120processed paraffin blocks. Soaking may result in a water artifact on the stained slide or in the tissue section(s) “disintegrating” when floated on the surface of the water.

If the paraffin ribbon fails to stretch out properly, the waterbath temperature may need to be increased slightly to approximately 45°- 46°C.

Compression of the ribbon may be eliminated by cooling the block by spraying the paraffin block with a freezing spray just prior to ribboning or by adjusting the knife angle.

Embedding of Tissue-Tek Xpress x120 Processed Tissue

Tissue cassettes are placed into the holding chamber of the embedding center and embedded following laboratory protocol.

Please note that an acetic acid (vinegar) odor may sometimes be noted upon removal of the lid from the processed tissue cassette. This odor is present when tissue is cut too thick for proper processing or the onboard reagens are past their useful life.

NOTE: Improperly processed Tissue-Tek Xpress x120 and traditionally processed tissue may sometimes appear as white areas on the embedded paraffin blocks, and/or may show areas that appear sunken the day after microtomy.

Staining

Tissue fixed in Formalin prior to Tissue-Tek Xpress x120 processing will stain similar to traditionally processed tissue.

Molecular-fixed tissue will stain slightly more intensely than Formalin-fixed tissue. The current laboratory staining protocols may require an adjustment to the staining time when using Hematoxylin and Eosin stains with tissue fixed in Molecular Fixative (see “Use of Tissue-Tek Molecular Fixative”on page A.2 for details).

Special stains performed on Tissue-Tek Xpress x120 processed tissue will appear similar to special stains performed on traditionally processed tissue regardless of the fixative used.

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Microscopic Evaluation

Moderate swelling of red blood cells may be noted.

Artifact - A retraction artifact that may be observed between epithelial cells and the underlying connective tissue when tissue is placed directly into Molecular Fixative or if the tissue was insufficiently fixed. The artifact may appear as a halo that surrounds the tissue cell(s). The artifact may also be noted on tissues that have been processed using Formalin fixation. This artifact may appear more prominent on Molecular-fixed tissue.

Reprocessing of Tissue

Tissue-Tek Xpress x120-processed tissue may be reprocessed, if necessary, without adverse affects on the tissue. Tissue that has been trimmed too thick for proper processing can be reprocessed using the following reprocessing procedure.

Procedure:

1. Place tissue cassette in a 60°C oven or in the Tissue

Embedding Center and allow the block to melt down.

2. Remove tissue and place in a cassette identified with

the proper accession number. It is important to note the thickness of the residual tissue.

3. Place labeled cassette in solvent (xylene or

xylene substitute) for 30 minutes (two changes).

4. Place cassette with tissue in a beaker containing

absolute alcohol for 30 minutes (two changes).

5. Remove cassettes from the alcohol.

6. Retrim tissue to the correct thickness, as necessary.

7. Place tissue in processing basket, then place the

basket in Pre-Processing container filled with PreProcessing Solution for 15 minutes.

8. Place processing basket in the Loading Station, with

the preprocessing step enabled and set for 30 minutes.

9. Depending on the thickness of the residual tissue,

select the appropriate immersion program (2mm or 3mm).

10. Enter number of cassettes loaded, as required.

11. At completion of the processing program, remove and

embed tissue as usual.

Revised 10/02/2012 A.5

Tissue-Tek Xpress x120 Reagent Replacement Schedule

It is recommended that Tissue-Tek Xpress x120 reagents be replaced after processing up to approximately 1,500 cassettes, or up to every 3 days, whichever occurs first. Reagent integrity depends on the type of tissues processed. Reagents cannot be topped off or rotated. All reagents must be replaced at the same time to ensure proper processing of tissue samples.

NOTE: The user may want to change the reagent set more frequently depending on the tissue type or shifts of operation.

Pre-processing solution in the Loading Station should

be changed every 3 hours.

Signs of reagent over-use are:

• The odor of vinegar is noted when opening the

Paraffin Ovens lids.

• Paraffin feels slippery or oily when the tissue is

embedded.

• White areas are noted on the majority of the uncut

paraffin blocks.

• Tissue “disintegrates” when ribbon is floated on the

waterbath.

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APPLICATIONS MANUAL

Do’s and Don’ts

• DO leave breast or fatty tissue in Pre-Processing

Solution 30 to 60 minutes to firm tissue prior to trimming.

• DO NOT use blue sponges for processing of tissue.

• DO use embedding bags, lens paper, etc.

• DO NOT process tissue for RNA studies with

Formalin-fixed tissue or solutions that have been used for Formalin-fixed tissue.

• DO run RNA tissue after the processor is cleaned and

solutions are all changed.

• DO NOT process tissue with O.C.T. compound (used

for Cryotomy) residue in the Tissue-Tek Xpress x120.

• DO remove all O.C.T. compound (used for Cryotomy)

from specimens by rinsing with water prior to placing in the Tissue-Tek Xpress x120.

• DO NOT process tissue thicker than 2 mm in

thickness on the Standard program.

• DO process tissue that is more than 3 mm in

thickness using the Extended program.

• DO NOT allow the faced tissue blocks to soak too

long in water.

• DO face the block and allow the block to soak/or cool

only for a short period of time.

• DO NOT use metal cassette lids.

• DO use plastic lids and remove metal staples and

sutures from tissue prior to placement in the cassette.

• DO NOT top off reagents or rotate reagents.

• DO change the reagents and solution after 1,500

cassettes or every 3 days, whichever occurs first.

• DO seal blocks after Microtomy with a thin layer of

paraffin if block will later be used for molecular studies

Disposal of Tissue-Tek Xpress x120 Processing Solutions

Refer to MSDS sheets. Disposal should be in accord-

ance with Local, State and Federal regulations.

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Tissues in cassettes sectioned at final thickness of 2 mm should be immersed for 1 hour in 10% NBF.

Alternative step to address specific

Place in Loading Station filled with PPS with

Tissues in cassettes sectioned at final thickness of 3 mm should be immersed for 3 hours in 10% NBF.

Alternative step to address specific

Place in Loading Station filled with PPS with

Immersion in PPS for 30 minutes. (offline)

Tissue-Tek Xpress x120 Processing Flow Chart for Standard Program

Pathologists’ preferences-

Immersion in PPF for 30 minutes.

Alternative step for Formalin-Free Tissue Processing-

Collect and fix tissues in Molecular Fixative, then gross to final thickness and immerse in

Molecular Fixa

tive for 1 hour.

Immersion in PPS for 30 minutes. (offline)

immersion time set for 15 minutes, and reagent usage limit set at 3 hours.

Tissue-Tek Xpress x120 Processing Flow Chart for Extended Program

Pathologists’ preferences-

Immersion in PPF for 30 minutes.

Alternative step for Formalin-Free Tissue Processing-

Collect and fix tissues in Molecular Fixative, then gross to final thickness and immerse in

Molecular Fixa

tive for 1 hour.

immersion time set for 30 minutes, and reagent usage limit set at 3 hours.

NOTES:

• As needed, tissue difficult to section, can be im-

mersed in PPS for 15 minutes to firm up.

• Some immersion times can be significantly reduced

for small biopsies. The above baseline procedure

Revised 10/02/2012 A.7

creates optimal conditions for the Xpress technology.

• Breast, placenta, lymph nodes, and other fatty tis-

sues may require longer immersion times in PPS (60 minutes).

• PPS to be changed every 3 hours.

• For Breast tissues requiring IHC testing, time in

10% NDB must be a minimum of 6 hours to satisfy the ASCO guidelines.

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A.8 Revised 10/02/2012

Sakura Tissue-Tek Xpress x120 Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual