Leica AutoStainerXL Manual de usuario

Instructions for Use

Leica AutoStainerXL

Automated slide stainer

Leica AutoStainerXL, V2.5, English – 01/2017

Order No.: 14 0456 80101 RevH

Always keep this manual with the instrument.

Read carefully before working with the instrument.

Leica AutoStainer XL – Automated slide stainer

Leica Biosystems Nussloch GmbH

Heidelberger Str. 17 - 19

D-69226 Nussloch

Germany

Phone: +49 6224 143-0

Fax: +49 6224 143-268

Internet: http://www.LeicaBiosystems.com

These are determined only by the contract

provisions agreed between ourselves and our

customers.

Leica reserves the right to change technical spec-

ifications as well as manufacturing processes

without prior notice. Only in this way is it pos-

sible to continuously improve the technology and

manufacturing techniques used in our products.

This document is protected under copyright laws.

All copyrights to this documentation are held by

Leica Biosystems Nussloch GmbH.

Any reproduction of text and illustrations (or of

any parts thereof) by means of print, photocopy,

microfiche, web cam or other methods – includ-

ing any electronic systems and media – requires

express prior permission in writing by Leica Bio-

systems Nussloch GmbH.

For the instrument serial number and year of

manufacture, please refer to the nameplate on

the back of the instrument.

The information, numerical data, notes and value

judgments contained in this manual represent

the current state of scientific knowledge and

state-of-the-art technology as we understand it

following thorough investigation in this field. We

are under no obligation to update the present

manual periodically and on an ongoing basis ac-

cording to the latest technical developments, nor

to provide our customers with additional copies,

updates etc. of this manual.

To the extent permitted in accordance with the

national legal system as applicable in each indi-

vidual case, we shall not be held liable for errone-

ous statements, drawings, technical illustrations

etc. contained in this manual. In particular, no

liability whatsoever is accepted for any financial

loss or consequential damage caused by or

related to compliance with statements or other

information in this manual.

Statements, drawings, illustrations and other infor-

mation regarding the contents or technical details

of the present Instructions for Use are not to be con-

sidered warranted characteristics of our products.

Note

4Instructions for Use V2.5 – 01/2017

Table of Contents

1. Important Information ............................................................................................................... 6

1.1 Symbols in the text and their meanings.................................................................................... 6

1.2 Intended use/improper use......................................................................................................... 8

1.3 User group ..................................................................................................................................... 8

2. Safety........................................................................................................................................... 9

2.1 General safety notes.................................................................................................................... 9

2.2 Specific safety notes.................................................................................................................... 9

3. Instrument Features................................................................................................................. 10

3.1 Overview and instrument components................................................................................... 12

3.2 Standard delivery – packing list............................................................................................... 14

3.3 Technical data............................................................................................................................. 15

4. Installing the Instrument ........................................................................................................ 16

4.1 Installation site requirements................................................................................................... 16

4.2 Connections on the instrument ................................................................................................ 16

4.2.1 Power supply............................................................................................................................... 16

4.2.2 Water supply ............................................................................................................................... 17

4.3 Battery backup – UPS (optional).............................................................................................. 18

4.4 Remote alarm (optional) ............................................................................................................ 19

4.5 Vacuum extraction system for reagent vapors ..................................................................... 19

4.6 Oven.............................................................................................................................................. 19

5. Operating the Instrument........................................................................................................ 20

5.1 The control panel........................................................................................................................ 21

5.2 Main menu................................................................................................................................... 22

5.3 Menu overview ........................................................................................................................... 23

5.4 Editing programs......................................................................................................................... 24

5.4.1 Entering program steps ............................................................................................................. 25

5.4.2 Deleting program steps ............................................................................................................. 26

5.4.3 Inserting a blank step into a program ..................................................................................... 26

5.4.4 Removing blank steps from a program ................................................................................... 27

5.4.5 Saving a program........................................................................................................................ 27

5.4.6 Deleting a program..................................................................................................................... 27

5.4.7 Copying a program ..................................................................................................................... 28

5.4.8 Viewing a program ..................................................................................................................... 29

5.4.9 Checking the compatibility of programs................................................................................. 29

5.5 User-adjustable parameters..................................................................................................... 31

5.6 Oven.............................................................................................................................................. 31

Leica AutoStainer XL – Automated slide stainer

Table of Contents

5.7 Up/down movement (dips) ........................................................................................................ 32

5.8 Number of up/down movement (dips)..................................................................................... 33

5.9 Staining......................................................................................................................................... 33

5.9.1 Reagent containers.................................................................................................................... 34

5.9.2 Wash system............................................................................................................................... 34

5.9.3 Water-saving function............................................................................................................... 35

5.9.4 Loading specimen slide holders............................................................................................... 35

5.9.5 Unloading specimen slide holders from the exit drawer..................................................... 36

5.9.6 Unloading specimen slide holders from other stations ....................................................... 36

5.9.7 Interrupting staining................................................................................................................... 37

5.9.8 Aborting the processing of a specimen slide holder............................................................ 38

6. Care and Cleaning ................................................................................................................... 39

6.1 Cleaning the instrument............................................................................................................. 39

6.1.1 Wash containers......................................................................................................................... 39

6.1.2 Reagent containers.................................................................................................................... 39

6.1.3 Specimen slide holders ............................................................................................................. 39

6.1.4 Oven.............................................................................................................................................. 39

7. Error messages and troubleshooting................................................................................... 40

7.1 Warning messages for instrument errors .............................................................................. 41

7.2 More information and warnings............................................................................................... 42

7.2.1 During staining............................................................................................................................ 42

7.2.2 During editing of programs ....................................................................................................... 43

7.2.3 During SetUp ............................................................................................................................... 44

8. Warranty and Service............................................................................................................. 45

APPENDIX 1......................................................................................................................................... 46

Adjustable parameters.......................................................................................................................... 46

APPENDIX 2......................................................................................................................................... 47

Consumables and accessories............................................................................................................ 47

APPENDIX 3......................................................................................................................................... 50

Compatible staining programs............................................................................................................. 51

Glossary................................................................................................................................................ 52

6Instructions for Use V2.5 – 01/2017

General information

These Instructions for Use include important instructions and information

related to the operating safety and maintenance of the instrument.

The Instructions for Use are an important part of the product, and must be

read carefully prior to startup and use and must always be kept near the

instrument.

If additional requirements for accident prevention and environmental protection

apply in the country of operation, these Instructions for Use must be supplement-

ed by appropriate instructions to ensure compliance with such requirements.

Make sure to read all of these Instructions for Use before you work on or

operate the instrument.

1.1 Symbols in the text and their meanings

Warnings appear in a gray box and are marked by a warning

triangle .

Useful tips, i.e. important information for the user, appear in

gray boxes and are marked by an .

(5)

(Fig. 5) Numbers in parentheses refer to item numbers in illustrations

or to the illustrations themselves.

Instrument type:

All information in these Instructions for Use applies only to the Leica Auto-

Stainer XL described here.

A nameplate indicating the instrument serial number is attached to the rear

side of the instrument.

Fig. 1 is provided as an example only and shows a valid name-

plate for this instrument with the necessary information about

instrument type and power requirement. The precise data for the

various versions is specified in Chapter 3.3 "Technical data".

Be sure to comply with the safety instructions and warnings

in Chapter 2. Be sure to read these notes even if you are already

familiar with the operation and use of other Leica products.

1. Important Information

Leica AutoStainer XL – Automated slide stainer

1. Important Information

Symbol Title of the symbol Description

In vitro diagnostic

medical device

Indicates a medical device that is intended to be used as an in

vitro diagnostic medical device.

Consult Instructions

for Use

Indicates the need for the user to consult the Instructions for

Use.

China ROHS Environmental protection symbol of the China RoHS directive.

The number in the symbol indicates the "Environment-friendly

Use Period" of the product in years. The symbol is used if a

substance restricted in China is used in excess of the maximum

permitted limit.

WEEE Symbol The WEEE symbol, indicating separate collection for WEEE -

Waste of electrical and electronic equipment, consists of the

crossed-out wheeled bin (§ 7 ElektroG).

Caution Indicates the need for the user to consult the Instructions for

Use for important cautionary information such as warnings and

precautions that cannot, for a variety of reasons, be presented

on the medical device itself.

CE Compliance The CE marking is the manufacturer's declaration that the

medical product meets the requirements of the applicable EC

directives.

Fig. 1

8Instructions for Use V2.5 – 01/2017

1. Important Information

Symbol Title of the symbol Description

Serial number Indicates the manufacturer's serial number so that a specific

medical device can be identified.

Article number Indicates the manufacturer's catalog number so that the medi-

cal device can be identified.

Date of manufacture Indicates the date when the medical device was manufactured.

Manufacturer Indicates the manufacturer of the medical product.

When making inquiries, it is important to specify the instrument type and

serial number correctly.

1.2 Intended use/improper use

- The AutoStainer XL has been designed for staining in medical, biological

and industrial applications.

- The instrument must be used exclusively according to the instructions

contained in these Instructions for Use.

- Any other use of the instrument is considered improper.

1.3 User group

- The AutoStainer XL should be operated by trained laboratory personnel

only.

- All laboratory personnel designated to operate the AutoStainer XL must

read these Instructions for Use carefully and must be familiar with all

technical features of the instrument before attempting to operate the

AutoStainer XL.

To prevent damage to the instrument and specimens, only

those accessories and spare parts that have been authorized

by Leica may be installed or used with the instrument.

Leica AutoStainer XL – Automated slide stainer

2. Safety

2.1 General safety notes

This instrument has been built and tested in accordance with the safety

requirements for electrical equipment for measurement, control, and labo-

ratory use.

To maintain this condition and ensure safe operation, the user must observe

all notes and warnings contained in these Instructions for Use.

For current information about applicable standards, please refer to the CE

Declaration of Conformity on our Internet site:

www.LeicaBiosystems.com

2.2 Specific safety notes

In accordance with national rules and regulations, the opera-

tor may be obligated to provide long-term protection of the

public water supply from contamination due to backflowing

water from the building installation. In Europe, the protec-

tion device of the potable water installation to be connected

is selected in accordance with the specifications of DIN EN

1717:2011-08 (information status August 2013).

10 Instructions for Use V2.5 – 01/2017

3. Instrument Features

General description

The AutoStainer XL was developed with the goal of satisfying the quality

requirements of modern laboratories:

• highspecimenthroughput,

• flexibility,

• safety.

The AutoStainer XL achieves its high throughput by means of a specimen

slide transport system, which allows for simultaneous processing of up to

11 specimen slide holders, each with 30 slides.

The flexibility of AutoStainer XL permits simultaneous processing of speci-

men slide holders according to various staining protocols.

An oven is integrated into the instrument for quickly drying specimen slides.

Optimized wash stations provide for rapid removal of reagent residue. The

design of the specimen slide holders ensures minimal reagent displacement

and prevents the reagents from being contaminated by liquid dripping into

them and needing to be replaced prematurely.

The AutoStainer XL is safe to use and has an integrated system for extract-

ing reagent vapors. The specimen slide holders are loaded and unloaded

using two drawers.

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