Sakura Tissue-Tek Xpress x120 Operating Manual

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Operating

Manual

Tissue-Tek

Rapid Tissue Processor

Xpress® x120

Operating

Manual

Operating

Manual

Tissue-Tek

Rapid Tissue Processor

Xpress

x120

Operating

Manual

0004389-03 Rev.C

Manufactured for:

Printed in U.S.A.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

INTRODUCTION

1.14 Revised 10/02/2012

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

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

(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

INSTALLATION

2.4 Revised 10/02/2012

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

+ 57 hidden pages

Sakura Tissue-Tek Xpress x120 Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual