Leica Microsystems HistoCore CHROMAX ST User manual

HistoCore CHROMAX ST
Automated Slide Stainer
Instructions for Use
English
Order No.: 14 0486 87101 - Revision A
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 1.0, Revision A - 09.2022

产品名称：染色机 产品型号： HistoCore CHROMAX ST 生产日期：见标签
备案人名称：徕卡显微系统（上海）有限公司
备案人住所：中国（上海）自由贸易试验区金藏路258号T20-1幢1层、2层、3层A区、4层A
区、6层、T20-5幢301室
联系方式： 021-58994990
生产企业名称：徕卡显微系统（上海）有限公司
生产企业住所：中国（上海）自由贸易试验区金藏路258号T20-1幢1层、2层、3层A区、4层A
区、6层、T20-5幢301室
生产地址：中国（上海）自由贸易试验区金藏路258号T20-1幢1层、2层、3层A区、4层A区、6
层、T20-5幢301室
联系方式：021-58994990
生产备案凭证编号： 沪浦食药监械生产备20010623号
医疗器械备案凭证编号：沪浦械备 20210139 号
产品技术要求编号： 沪浦械备 20210139 号
售后服务提供商名称：徕卡显微系统（上海）贸易有限公司
售后服务提供商地址：中国（上海）自由贸易试验区富特北路 127 号3 楼C 部位
售后服务提供商电话：[phone]
售后服务提供商传真：[phone]

3
HistoCore CHROMAX ST
The information, numerical data, notes and value judgments contained in this Instructions for Use
represent the current state of scientic knowledge and state-of-the-art technology as we understand it
following thorough investigation in this eld.
We are under no obligation to update the present Instructions for Use periodically and on an ongoing
basis according to the latest technical developments, nor to provide our customers with additional
copies, updates etc. of this Instructions for Use.
To the extent permitted in accordance with the national legal system as applicable in each individual
case, we shall not be held liable for erroneous statements, drawings, technical illustrations etc. contained
in this Instructions for Use. In particular, no liability whatsoever is accepted for any nancial loss or
consequential damage caused by or related to compliance with statements or other information in this
Instructions for Use.
Statements, drawings, illustrations and other information regarding the contents or technical details of
the present Instructions for Use are not to be considered warranted characteristics of our products.
These are determined only by the contract provisions agreed between ourselves and our customers.
Leica reserves the right to change technical specications as well as manufacturing processes without
prior notice. Only in this way is it possible 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Microsystems Ltd. (Shanghai).
Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy,
microche, web cam or other methods – including any electronic systems and media – requires express
prior permission in writing by LeicaMicrosystems Ltd. (Shanghai).
For the instrument serial number and year of manufacture, please refer to the nameplate on the back of
the instrument.
Leica Microsystems Ltd. (Shanghai)
Floor 1, 2, 3A, 4A, and 6, Building T20-1 & Room 301, Building T20-5, 258 Jinzang Road,
China (Shanghai) Pilot Free Trade Zone, Shanghai, 201206
PEOPLE'S REPUBLIC OF CHINA
Tel.: [phone]
Fax: [phone]
Web: www.LeicaBiosystems.com
Note

4Version 1.0, Revision A
Table of contents
1. Important Information ..................................................................................................6
1.1 Symbols and their meanings....................................................................................................... 6
1.2 Instrument type ........................................................................................................................10
1.3 Intended use.............................................................................................................................10
1.4 Qualicationofpersonnel .........................................................................................................10
2. Safety...................................................................................................................... 11
2.1 Safety notes .............................................................................................................................11
2.2 Warnings..................................................................................................................................11
2.2.1 Markings on the instrument itself ..............................................................................................12
2.2.2 Transport and installation..........................................................................................................12
2.2.3 Operating the instrument...........................................................................................................12
2.2.4 Handling reagents.....................................................................................................................14
2.2.5 Cleaning and Maintenance ........................................................................................................15
3. InstrumentComponentsandSpecications ................................................................... 16
3.1 Overview ..................................................................................................................................16
3.1.1 Instrument components ............................................................................................................16
3.1.2 Rear panel ................................................................................................................................17
3.2 Main features of the instrument.................................................................................................17
3.3 Technical data ..........................................................................................................................18
4. Setting up the Instrument ........................................................................................... 21
4.1 Installation site requirements ....................................................................................................21
4.2 Standard delivery - packing list ..................................................................................................21
4.3 Unpacking instructions..............................................................................................................22
4.4 Water connections ....................................................................................................................23
4.5 Air exhaust system for reagent vapors .......................................................................................24
4.6 Oven ........................................................................................................................................24
4.7 Battery backup – UPS (optional)................................................................................................24
4.8 Remote alarm (optional)............................................................................................................25
4.9 Switching on/off.......................................................................................................................26
4.10 Moving the instrument ..............................................................................................................27
5. Operation ................................................................................................................. 28
5.1 User interface - overview ...........................................................................................................28
5.1.1 Elements of the Status screen ..................................................................................................28
5.1.2 Process Status screen ..............................................................................................................29
5.1.3 Keyboards ................................................................................................................................29
5.2 User management.....................................................................................................................30
5.2.1 Access levels............................................................................................................................30
5.2.2 Initial log-in ..............................................................................................................................31
5.2.3 Adding/Editing/Deleting a user account.....................................................................................31
5.2.4 Logout......................................................................................................................................31
5.2.5 Locking/Unlocking the screen....................................................................................................31
5.3 Settings....................................................................................................................................32
5.3.1 General setting .........................................................................................................................32
5.3.2 Slide counting report.................................................................................................................33
5.3.3 Reagent exchange report...........................................................................................................34
5.3.4 User run log report ....................................................................................................................34

5
HistoCore CHROMAX ST
Table of contents
5.3.5 Service.....................................................................................................................................34
5.4 RMS (Reagent Management System) .........................................................................................34
5.4.1 Reagent information .................................................................................................................34
5.4.2 Station management.................................................................................................................35
5.4.3 Reagent management ...............................................................................................................36
5.5 Programs .................................................................................................................................37
5.5.1 Leica staining programs (pre-installed) ......................................................................................38
5.5.2 User-denedstainingprograms .................................................................................................39
5.5.3 Adding/Viewing/Editing/Copying/Deleting a program .................................................................39
5.5.4 Setting favorite programs..........................................................................................................41
5.5.5 Checking the compatibility of programs .....................................................................................41
5.6 Staining....................................................................................................................................42
5.6.1 Reagent containers ...................................................................................................................42
5.6.2 Filling reagents.........................................................................................................................43
5.6.3 Wash system ............................................................................................................................44
5.6.4 Water-saving function ...............................................................................................................44
5.6.5 Loading racks...........................................................................................................................44
5.6.6 Viewing the running information during staining.........................................................................46
5.6.7 Unloading racks from the EXIT drawer .......................................................................................46
5.6.8 Unloading racks from other stations ..........................................................................................47
5.7 Interrupting staining..................................................................................................................47
5.8 Aborting the processing of a rack ..............................................................................................48
5.9 Replacing reagents ...................................................................................................................48
5.10 Pre-installed program................................................................................................................49
6. Cleaning and Maintenance .......................................................................................... 50
6.1 Wash containers .......................................................................................................................50
6.2 Reagent containers ...................................................................................................................50
6.3 Racks.......................................................................................................................................50
6.4 Oven ........................................................................................................................................50
6.5 Water drainage .........................................................................................................................51
6.6 Cleaning and Maintenance Schedule..........................................................................................51
7. Troubleshooting........................................................................................................ 52
7.1 Warning messages for instrument errors....................................................................................52
7.2 More information and warnings .................................................................................................53
7.2.1 During staining .........................................................................................................................53
7.2.2 During SetUp ............................................................................................................................53
7.3 Power failures ..........................................................................................................................53
8. Ordering Information.................................................................................................. 54
A1. DecontaminationConrmation .................................................................................... 55
A2. Warranty and Service ................................................................................................. 56
A3. Information on Hazardous Substances.......................................................................... 57

6Version 1.0, Revision A
1Important Information
1. Important Information
1.1 Symbols and their meanings
Symbol: Title of the symbol: Danger
Description: Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injuries.
Symbol: Title of the symbol: Warning
Description: If this danger is not avoided, then this may result in death or
serious injury.
Symbol: Title of the symbol: Caution
Description: Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Symbol: Title of the symbol: Note
Description: Indicates information which are important but not related to
any risk.
Symbol: Title of the symbol: Item number
→Fig. 7-1Description: Item numbers for numbering illustrations. Numbers in red
refer to item numbers in illustrations.
Symbol: Title of the symbol: Software designations
Admin Description: Software designations that have to be displayed on the
input screen are displayed as bold, gray text.
Symbol: Title of the symbol: Function key
Save Description: Function keys to be pressed on the instrument are
displayed as bold, gray and underlinded text.
Symbol: Title of the symbol: Keys and switches on the instrument
Power switch Description: Keys and switches on the instrument that are supposed to
be pressed by the user in various situations are displayed
as bold, gray and underlinded text.
Symbol: Title of the symbol: Manufacturer
Description: Indicates the manufacturer of the medical product.
Symbol: Title of the symbol: Manufacturing date
Description: Indicates the date when the medical device was
manufactured.
Symbol: Title of the symbol: Article number
Description: Indicates the manufacturer's catalog number so that the
medicaldevicecanbeidentied.
Symbol: Title of the symbol: Serial number
Description: Indicates the manufacturer's serial number so that a
specicmedicaldevicecanbeidentied.
Symbol: Title of the symbol: Consult Instructions for Use
Description: Indicates the need for the user to consult the Instructions
for Use.
Symbol: Title of the symbol: Caution

7
HistoCore CHROMAX ST
1Important Information
Description: 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.
Symbol: Title of the symbol: Caution – Moving parts
Description: Label is attached on the transport arm. It indicates a risk
of collision between the transport arm and any operator
working within the instrument while the transport arm is
moving.
Symbol: Title of the symbol: Caution – Toxic chemicals/Flammable substances
Description: Labelsareattachedinsidetheinstrumentbelowthexation
of the hood (in the middle).
Therstlabelindicatesthattoxicchemicalsareinside
the instrument. Do not handle solution containers unless
properly protected.
Thesecondlabelindicatesthatthereisariskofre
becauseofammablesubstancesinsidetheinstrument.
Thus, avoid any source of ignition close to the instrument.
Symbol: Title of the symbol: Caution – Hot surface
Description: Two labels are attached close to the oven. They indicate a
risk of burns because of hot surfaces. Do not touch these
parts.
Symbol: Title of the symbol: Biohazard
Symbol: Title of the symbol: Caution – Risk of crushing
Description: Reminds users to be careful to open/close the hood.
Symbol: Title of the symbol: Caution–Riskofre
Description: Label is attached at the rear of the instrument close
tothefuse.Itindicatesariskofreincasethatnoor
inappropriate fuses are used. For continued protection
againsttheriskofrereplaceonlywithappropriatefuses
as indicated on the instrument.
Symbol: Title of the symbol: Caution – Input voltage
Description: Label is attached at the rear of the instrument above the
switched mains power inlet. It indicates that the unit is
wired either for 100-120 VAC or 230-240 VAC (depending
on your order). Do not change wiring or voltage selection
onyourownbutcontactqualiedLeicaBiosystemsservice
personnel in this case.
Symbol: Title of the symbol: Caution – Water supply and interfaces
Description: Labels are attached at the rear of the instrument close
to the serial port and the water supply connections. They
indicate that both Instructions for Use and – if applicable –
any inscription on the instrument must be observed.

8Version 1.0, Revision A
1Important Information
Symbol: Title of the symbol: Caution - Laser light
Description: Label is attached close to the slides counting sensor.
Symbol: Title of the symbol: China ROHS
Description: 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.
Symbol: Title of the symbol: PE terminal
Symbol: Title of the symbol: ON/OFF (Power)
Description: In position of power on/off
"I" = ON
"O" = OFF
Symbol: Title of the symbol: Stand-by
Symbol: Title of the symbol: Fragile, handle with care
Description: The package contents are fragile and must be handled with
care.
Symbol: Title of the symbol: Store dry
Description: The package must be kept in a dry environment.
Symbol: Title of the symbol: Stacking limitation
Description: Maximum number of identical packages that may be
stacked, where 1 stands for the number of permitted
packages.
Symbol: Title of the symbol: This way up
Description: Indicates the correct upright position of the package.
Symbol: Title of the symbol: Temperature limit for transport
Description: Indicates the temperature range permitted for transporting
the package.

9
HistoCore CHROMAX ST
1Important Information
Symbol: Title of the symbol: Temperature limit for storage
Description: Indicates the temperature range permitted for storing the
package.
Symbol: Title of the symbol: Humidity limitation for transport and storage
Description: Indicates the humidity range permitted for storing and
transporting the package.
Symbol: Title of the symbol: Shockdot Impact Indicator
Description: In the Shockwatch system, the shock dot shows impacts
orshocksthatareaboveaspeciedintensitythroughred
colouration.Exceedingadenedacceleration(gvalue)
causes the indicator tube to change colour.
Symbol: Title of the symbol: Tilt indicator
Description: Tip-n-Tell indicator to monitor whether the shipment has
been transported and stored in upright position according
to your requirements. With a pitch of 60° or more, the blue
quartzsandowsintothearrow-shapedindicatorwindow
and sticks there permanently. Improper handling of the
shipment is immediately detectable and can be proven
denitively.
Symbol: Title of the symbol: Recycle symbol
Description: Indicates the item can be recycled where correct facilities
exist.
1.2 Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on
the cover page. A nameplate indicating the instrument serial number is attached to the rear side of the
instrument.
1.3 Intended use
The HistoCore CHROMAX ST Automated Slide Stainer is an IVD (in-vitro diagnostics) instrument.
The HistoCore CHROMAX ST Automated Slide Stainer is a stainer for laboratory applications and
intended for the preparation of histological tissue samples. This product is used for staining of cells,
tissue samples, etc. before pathological analysis.

10 Version 1.0, Revision A
1Important Information
Warning
• Any use of the instrument that deviates from the designated use is considered improper.
Failure to adhere to these instructions may result in an accident, personal injury, damage to
the instrument or accessory equipment. Proper and intended use includes compliance with
all inspection and maintenance instructions, along with the observance of all instructions in
the Instructions for Use as well as the constant inspection of the reagents for storage life and
quality.TheHistoCoreCHROMAXSTAutomatedSlideStainercarriesoutthespeciedstaining
steps automatically. The manufacturer assumes no liability for the staining results in the case
that the staining steps and programs are entered incorrectly. Thus, the end user is independently
responsible for self-created reagents or program entries.
1.4 Qualicationofpersonnel
The HistoCore CHROMAX ST Automated Slide Stainer must be operated by trained laboratory personnel
only. The instrument is intended for professional use only.
All laboratory personnel designated to operate this instrument must read these Instructions for Use
carefully and must be familiar with all technical features of the instrument before attempting to operate
it.