MLT FS-16-25 Manuel utilisateur

Automated Slide Stainer FS-16-25

Instruction for Use

Read carefully before working with the stainer

Always keep this Instructions for Use near the stainer

V1.1 English – 10.02.2021

Dubna

Revision history

Revision Effective date Change Written by

1.0 22.01.2021 Draft Bezrukov A.V.

1.1 10.02.2021 For CE marking Kutepov M.V.

Bezrukov A.V.

FORBIDDEN TO OPERATE THE STAINER WITHOUT PRIOR READING THE

INSTRUCTION FOR USE.

CAUTION! ALWAYS KEEP THIS INSTRUCTION FOR USE NEAR THE

STAINER.

MLT LLC reserves the right to change technical specifications as well as

manufacturing processes without prior notice. Only this way is it possible to

continuously improve the technology and manufacturing techniques. The information

on important changes is added to the technical file of the device and is published on

the manufacturer’s website www.mlt.ru.

The latest technological programs, tutorial video materials, as well as

supplementary documents for the device FS-16-25 are available on the website

www.fastainer.com, section http://fastainer.com/resources.

Any copyrights of this document are retained by MLT LLC.

Any reproduction of text and illustrations of this document requires prior

permission in writing by MLT LLC.

For the device serial number and year of manufacture, please refer to the

nameplate at the back of the device.

MLT Limited Liability Company

Tehnologicheskaya street 7, 141981, Moscow Region, Dubna, Russia

Tel: +7 (495) 287 81 00; e-mail: [email protected], [email protected];

web: www.mlt.ru, www.fastainer.com

Table of contents

1 Important information ........................................................................................................ 5

1.1 Used symbols and indications .................................................................................... 5

1.1.1 Warning words. .................................................................................................... 5

1.1.2 Symbols. .............................................................................................................. 6

1.1.3 Stainer label. ........................................................................................................ 7

1.1.4 Designation of menu sections, touch screen buttons, and operational actions. ... 8

1.2 Intended use ............................................................................................................... 9

1.3 Compatibility with reagents and accessories of other manufacturers ......................... 9

1.4 Qualification of personnel ........................................................................................... 9

2 Safety ............................................................................................................................. 10

2.1 General safety statements ....................................................................................... 10

2.2 Special safety statements ........................................................................................ 10

3. General characteristics .................................................................................................. 12

3.1 Description of Stainer ............................................................................................... 12

3.1.1 Construction of Stainer. ......................................................................................... 12

3.1.2 Accessories: troughs and racks. ........................................................................ 15

3.1.4 Micro SD card and micro SD card slot. ............................................................. 16

3.1.5 Working principle of Stainer. .............................................................................. 16

3.2 Technical data .......................................................................................................... 18

3.3 Environmental conditions ......................................................................................... 18

3.4 Delivery set ............................................................................................................... 19

4. Unpacking and installation of Stainer ............................................................................ 20

4.1 Site requirements ..................................................................................................... 20

4.2 Unpacking of Stainer ................................................................................................ 20

4.3 Connection of Stainer ............................................................................................... 22

5. Operation and control of functioning .............................................................................. 25

5.1 Main menu, menu structure ...................................................................................... 25

5.2 Menu section «TECHNIQUES»: programming of new techniques, editing of

parameters of previously downloaded techniques.......................................................... 26

5.3 Menu section «CONFIGURATION»: programming and control of the configuration,

performing of service functions....................................................................................... 32

5.3.1 Setting the interval of the introduction of racks into the process. ....................... 36

5.3.2 Menu section «SERVICE». Performing of service functions. ............................. 38

5.4 Menu section «PROCESS»: loading and unloading of racks. Processing of racks

with slides according to a given technological program .................................................. 40

5.4.1 Automated system for loading and unloading racks through the gateway ................ 40

5.4.2 Automated loading and unloading of racks through the gateway. ...................... 41

5.4.3 Automated loading and unloading of racks through the manipulator. ................ 42

5.4.2 Loading of racks during the performance of a technological program. ............... 44

5.5 Status screen during a technological process ....................................................... 45

6. Preparing for operation .................................................................................................. 48

6.1 Switching on ............................................................................................................. 48

6.2 Check of working capacity ........................................................................................ 48

6.2.1 Positioning test. .................................................................................................. 48

7. Work sequence .............................................................................................................. 51

7.1 Before operation ....................................................................................................... 51

7.2 Switching on ............................................................................................................. 51

8 Cleaning, disinfection, and maintenance ........................................................................ 53

8.1 Cleaning and disinfection of outer surfaces and the working chamber ..................... 53

8.2 Flow-through trough and drain system ..................................................................... 53

8.3 Troughs for reagents ................................................................................................ 53

8.4 Racks ....................................................................................................................... 53

8.5 Mesh water filter ....................................................................................................... 54

8.6 Air filter ..................................................................................................................... 54

9 Troubleshooting .............................................................................................................. 55

10 Decommissioning and recycling ................................................................................... 55

11 Confirmation of performed sanitary treatment .............................................................. 56

APPENDIX A. Instruction on fire safety measures ............................................................ 57

1 General provisions ...................................................................................................... 57

2 Requirements to the room ........................................................................................... 57

3 Safety measures when handling HFL and CL ............................................................. 57

4 Actions in case of fire .................................................................................................. 58

APPENDIX B. List of reagents FS-16-25* ........................................................................ 59

APPENDIX С. Example of developing the <DEMO> program ........................................... 59

Protocol of the <DEMO> program and its configuration ................................................. 60

Listing of the <DEMO> program and its configuration .................................................... 61

APPENDIX D Template for developing a new technological program ............................ 62

( The file with the Template is available at fastainer.com/resources ) ........................... 62

APPENDIX E Recommended protocol of H&E (histology) ............................................. 63

APPENDIX F. List of adopted terms and abbreviations .............................................. 64

APPENDIX G. «FASTAINER FIRMWARE EDITOR» PC SOFTWARE ........................... 66

1 Important information

General

This instruction for use includes important information related to the operating safety

and maintenance of the automated slide stainer FS-16-25 (further – Stainer). The instruction

for use is an important part of the product. It must be read carefully and completely before

setup and prior use of the Stainer and must be kept near the device at all times. If additional

requirements on accident prevention and environmental protection exist in the country of

operation, the instruction for use must be supplemented by appropriate instructions to

ensure compliance with such requirements.

Diagnosis should not be made only with staining results obtained with Stainer.

FORBIDDEN TO OPERATE THE STAINER WITHOUT PRIOR READING THE

INSTRUCTION FOR USE. First of all, be sure to carefully read and comply with chapter 2

“Safety”.

1.1 Used symbols and indications

1.1.1 Warning words.

Warning words: CAUTION!, FORBIDDEN are marked by capital letters and white

font color on black background. The text following the warning words is marked by capital

letters.

When several warnings are standing together, they are grouped in such a way that

the first ones refer to the safety of personnel.

Symbol Description

CAUTION!

The CAUTION! sign is used to attract the attention of personnel to

the ways and methods that should be strictly followed to avoid

mistakes in operation and repair of the Stainer, or when extra

carefulness is vital in handling the device or materials.

FORBIDDEN

The FORBIDDEN sign is used to indicate that a violation of the

defined limitations or nonobservance of the requirements, referring

to the usage of materials, as well as to the ways and methods of

handling the Stainer, may lead to violation of safety measures.

1.1.2 Symbols.

Symbol Name of the symbol Location, designation

Warning, danger

Lid of the Stainer. A warning about handling of toxic

and corrosive reagents, about the necessity to use

protective equipment.

Fire hazard Lid of the Stainer. A warning about the handling of

highly flammable liquids.

Biological hazard

Lid of the Stainer. A warning about handling of

hazardous biological samples, about the necessity

to use protective equipment.

Warning, danger

Rear panel of the Stainer beside the fuses’ lid. A

warning about the risk of setting the device on fire if

fuses with the wrong rating are used.

Warning, danger

Manipulator housing in the center of the working

chamber. A warning about the risk of injuries by

moving manipulator.

Hot surface

Inside the working chamber beside the drying

station. The symbol indicate a risk of burns because

of hot surfaces. Do not touch these parts. The

symbol shown here indicates areas where the

temperature may exceed 60°C

OFF Right panel of the control unit, power switch.

ON Right panel of the control unit, power switch.

Device for IN VITRO

diagnostics

Instruction for use, label on the rear panel of the

Stainer.

Serial number Instruction for use, label on the rear panel of the

Stainer.

Catalog number Instruction for use, label on the rear panel of the

Stainer.

Manufacturer Instruction for use, label on the rear panel of the

Stainer.

Manufacture date Instruction for use, label on the rear panel of the

Stainer.

Authorized representative

in the EU

Instruction for use l, label on the rear panel of the

Stainer.

Fuse rating Instruction for use, label on the rear panel of the

Stainer.

Refer to the instruction for

use Operational documentation.

UP Labels on the packing box of the Stainer, indicating

the correct position of the cargo.

Fragile. Caution. Fragility of

the cargo. Careful handling

of the cargo.

Labels on the packing box of the Stainer, stating

the necessity of careful handling of fragile cargo.

Limit on the number of tiers

in a stack.

Labels on the packing box of the Stainer. The limit

number of tiers when piling in a stack – 2 (Two).

Protect from moisture. Labels on the packing box of the Stainer, stating

the necessity to protect the cargo from moisture.

Protect from sun radiation.

Labels on the packing box of the Stainer, stating

the necessity to protect the cargo from sun

radiation.

Open here Labels on the packing box of the Stainer.

Operational documentation.

MLT LLC logo

Instruction for use, label on the rear panel of the

Stainer, labels on the packing box of the device. A

stylized image of the manufacturing company’s

name.

1.1.3 Stainer label.

The label containing the Stainer’s name, its serial number, the year of manufacture

and other information is situated at the rear panel of the device. ( 3.1.1)

Figure 1. The appearance of the Stainer label.

1.1.4 Designation of menu sections, touch screen buttons, and operational

actions.

Menu sections are designated with capital letters between double angle quotation

marks, e.g., «PROCESS», «SERVICE», «CONFIGURATION», etc.

Touch screen buttons are designated in the text as inscriptions in capital letters

placed in a frame, e.g., ENTER, YES, STOP. The symbol  is designated a cyclic

switching of buttons.

Use of touch screen buttons with icons.

◄► – to switch between two screens with a list of names of technological programs.

▼, ▲ – to switch between screens with the same application (6 screens with a list of

reagents, screens with listings of a program).

– to erase the last entered symbol (digit).

Messages on the screen are designated with capital letters between single angle

quotation marks, e.g., <PROGRAM WAS CHANGED>, <SAVE THE CHANGES?>.

1.2 Intended use

The automated slide stainer FS-16-25 is a device for IN VITRO diagnostics. The

device is designated for the staining of biological preparations on slides. The primary

intended use is histology (particularly – H&E technique) and cytology (particularly –

Papanicolaou stain, for conventional and LBC preparations). The device also can be

successfully used for preparation staining in hematology, microbiology, parasitology.

FORBIDDEN TO USE THE STAINER FOR ANY PURPOSE OTHER THAN THE

DESIGNATED ONE.

The violation of this requirement may result in accidents, injuries, damages to the

device. The designated use comprises observance of all requirements of the instruction for

use, including observance of the control and maintenance intervals, a routine check of expiry

dates, and quality of reagents. The Stainer performs a chosen technological program

automatically. The manufacturer is not liable to respond if a mistake in programming or

during operation is made, inappropriate reagents are used, the reagents are placed

inappropriately, a program is started with closed lids of troughs, etc.

1.3 Compatibility with reagents and accessories of other manufacturers

The Stainer is an open system. The programs, supplied with the Stainer, may need

corrections of parameters or changes in programs if used with reagents of other

manufacturers. In most cases, a correction of the duration of technological treatments might

be needed. Staining kits manufactured by MLT LLC are supplied with an operational

instruction with a recommended technological program. The responsibility for independently

compiled programs, for reagents purchased from other manufacturers, or for self-

manufactured reagents is born by the end-user.

FORBIDDEN TO USE ACCESSORIES AND SPARE PARTS, NOT AUTHORIZED

BY THE MANUFACTURER.

1.4 Qualification of personnel

The FS-16-25 may be operated only by trained laboratory specialists – doctors and

lab technicians. All laboratory personnel designated to operate the Stainer must read this

instruction for use with all appendices carefully and must be familiar with all technical

features of the Stainer before attempting to operate it.

FORBIDDEN TO OPERATE THE STAINER UNLESS THE PERSONNEL HAS

COMPLETED A SAFETY TRAINING, AND UNLESS READ CAREFULLY THIS

INSTRUCTION FOR USE WITH ALL APPENDICES.

Table des matières

Autres manuels MLT Équipement de laboratoire

MLT

MLT PLYS 15 Manuel utilisateur

MLT

MLT FS-9-25 Manuel utilisateur

Manuels Équipement de laboratoire populaires d'autres marques

Qiagen

Qiagen DML 3000 Manuel utilisateur

Queensgate

Queensgate NANOSCAN OP400 Manuel de programmation

Conviron

Conviron GEN1000-GE Manuel utilisateur

Parr Instrument

Parr Instrument 4560 Mode d’emploi

IKA

IKA IC control Manuel utilisateur

Integra

Integra DOSE IT Manuel utilisateur

Agilent Technologies

Agilent Technologies 5800 ICP-OES Manuel utilisateur

Endress+Hauser

Endress+Hauser Cleanfit CPA875 Manuel utilisateur

NI PXI-5422 Manuel

Collomix

Collomix Aqix Manuel utilisateur

SPEX SamplePrep

SPEX SamplePrep 6875 Freezer/Mill Series Manuel utilisateur

Ocean Insight

Ocean Insight FLAME-NIR+ Manuel utilisateur

Parker

Parker ALIGN-MG-NA Manuel utilisateur

BD 644787 Manuel utilisateur

DENTAURUM

DENTAURUM Compact Megaplus Manuel utilisateur

Biuged Laboratory Instruments

Biuged Laboratory Instruments BGD 626 Manuel utilisateur

VWR

VWR SAS Super IAQ Manuel utilisateur

illumina

illumina MiSeqDx Manuel utilisateur