Leica Biosystems Nussloch SPECTRAST Multistainer User Manual

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DRAFT
2014-08-21
Instructions for Use
Leica HistoCore SPECTRA ST
V 0.5 RevC - 08/2014
Staining machine
Leica HistoCore SPECTRA ST V 0.5 RevC, English 08 /2014
Order No.: 14 0512 80100 RevC
Always keep this manual with the instrument.
Read carefully before working with the instrument.
DRAFT
2014-08-21
DRAFT
2014-08-21
NOTE
The information, numerical data, notes and value
judgments contained in this manual represent
the
current state of scientific
entific knowledge and state-ofsta
the-art technologyy as we understand it following
ation in this field.
thorough investigation
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 these 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 these Instructions for Use. In
particular, no liability whatsoever is accepted for
any financial loss or other consequential damage
caused by or related to compliance with statements or other information in these instructions
for use.
Statements, drawings, illustrations and other
g the contents or technical
information regarding
details of the present Instructions
for Use are not
Inst
too be considered warranted
characteristics of
warran
our products. These are determined only by the
contract provisions agreed between ourselves
and our customers.
Leica reserves the right to change technical specifications 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 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 – including any electronic systems and media – requires
express prior permission in writing by Leica Biosystems Nussloch GmbH.
For the instrument serial number and year of
manufacture, please refer to the nameplate on
the back of the instrument.
Š Leica Biosystems Nussloch GmbH
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
Leica HistoCore SPECTRA ST
Table of Contents
1.
Important Information ................................................................................................................. 5
1.1
1.2
1.3
1.4
1.5
2.
Installation site requirements ................................................................................................... 27
Running water connection ........................................................................................................ 28
Joint connection of all 6 rinsing water stations .................................................................... 29
Combined connection 4+2 rinsing water stations ................................................................. 30
Wastewater connection ............................................................................................................ 31
Electrical Connection ................................................................................................................. 32
Using an external uninterruptible power supply (UPS) ........................................................ 33
Exhaust air connection .............................................................................................................. 33
Switching the instrument on and off ....................................................................................... 34
Operation ..................................................................................................................................... 35
5.1
5.2
5.3
5.4
5.5
5.5.1
5.6
5.7
5.7.1
5.7.2
5.7.3
Standard delivery—packing list............................................................................................... 21
Technical Data ............................................................................................................................ 22
Overview ...................................................................................................................................... 24
Installation and Starting Up ..................................................................................................... 27
4.1
4.2
4.2.1
4.2.2
4.2.3
4.3
4.3.1
4.4
4.5
5.
Safety notes ................................................................................................................................. 14
Warnings ...................................................................................................................................... 16
Safety features on the instrument ........................................................................................... 20
Instrument Components and Specifications......................................................................... 21
3.1
3.2
3.3
4.
Instrument
ent
nt Name .........................................................................................
.......................................................................................................................... 5
meanings......................................................................
....................................................................
Symbols and their meanin
meanings.......................................................................................................
Instrument
........................................................................................................................... 13
ent
nt type ............................................................................................
Qualification
ation of personnel ......................................................................................................... 13
Intended use of instrument ....................................................................................................... 13
Safety ......................................................................................................................................... 14
2.1
2.2
2.3
3.
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2014-08-21
User interface – overview ......................................................................................................... 35
Status bar elements ................................................................................................................... 36
Process status display ............................................................................................................... 37
Displaying the drawers .............................................................................................................. 39
Main menu-overview ................................................................................................................. 40
The keyboard ............................................................................................................................... 41
User settings................................................................................................................................ 43
Basic settings .............................................................................................................................. 45
Language settings ...................................................................................................................... 46
Country-specific settings .......................................................................................................... 46
Date and time .............................................................................................................................. 47
Instructions for Use V 0.5 RevC - 08/2014
5.7.4
5.7.5
5.7.6
5.7.7
5.7.8
5.7.9
5.7.10
5.8
5.8.1
5.8.2
5.8.3
5.9
5.9.1
5.9.2
5.9.3
5.9.4
5.9.5
5.9.6
5.9.7
5.9.8
5.9.9
5.9.10
6.
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Table of Contents
Alarm and signal tones .............................................................................................................. 47
Setting
..........................................................................................................................
49
ngg the oven .....................................................................................
............................................................................
Movement
..............................................................
50
ement speed - up/down movement (agitation)
(agitatio .........................
............
Data management
......................................................................................................................
51
managemen .................................................................................
............................................................................
Service
ce access............................................................................................................................ 54
Event view .................................................................................................................................... 54
Network settings......................................................................................................................... 55
Reagent list .................................................................................................................................. 56
Define heated reagent (optional) ............................................................................................. 57
Creating a new reagent ............................................................................................................. 58
Process classes .......................................................................................................................... 60
Staining program ........................................................................................................................ 63
Staining program - general settings ........................................................................................ 64
Leica staining programs (preinstalled) ................................................................................... 65
Adapting the Leica H&E staining program ............................................................................. 66
User-defined staining programs ............................................................................................. 66
Creating a new staining program............................................................................................. 67
Inserting a new program step (continued) ............................................................................. 69
Resorting a program step .......................................................................................................... 70
Prioritizing programs .................................................................................................................. 71
Creating a bathlayout ................................................................................................................. 72
Adjusting a bathlayout ............................................................................................................... 75
Daily Instrument Setup ........................................................................................................... 78
6.1
6.2.
6.2.1
6.2.2
6.3
6.4
6.5
6.6
6.6.1
6.7.2
6.7.3
6.7.4
6.7.5
Preparing the instrument for daily setup ................................................................................ 78
Daily setup of the instrument .................................................................................................... 79
Preparation and handling of reagent cuvettes ...................................................................... 79
Automatic fill level scan ............................................................................................................ 81
Reagent management system (RMS) ...................................................................................... 82
Station features........................................................................................................................... 84
Prepare slide rack ...................................................................................................................... 89
The staining process .................................................................................................................. 91
Start the staining process ......................................................................................................... 91
Monitoring the staining process .............................................................................................. 93
Staining process completed ..................................................................................................... 94
Canceling the staining program ............................................................................................... 95
Operation as a workstation ....................................................................................................... 96
Leica HistoCore SPECTRA ST
Table of Contents
7.
Cleaning and Maintenance.................................................................................................... 98
7.1
7.1.1
7.1.2
7.1.3
7.1.4
7.1.5
7.1.6
7.1.7
7.1.8
7.1.9
7.1.10
7.1.11
7.1.12
7.1.13
7.1.14
7.1.15
7.1.16
7.2
8.
Important
ntt notes about this instrument cleaning
cleani ....................................
................................................................... 98
.....................
............
Exterior surfaces, varnished surfaces, instrument ccover
cover....................................................
98
TFT touchscreen
.........................................................................................................................
98
chscreen
hscreen ..........................................................................................
......................................................................................
Interior and drain pa
pan ................................................................................................................ 99
Transport arms ............................................................................................................................ 99
Reading module for specimen slides ...................................................................................... 99
Input and output drawers ........................................................................................................ 100
Dry transfer station................................................................................................................... 100
Transfer station (optional) ....................................................................................................... 100
Reagent cuvettes, rinsing water cuvettes and heated cuvettes (optional) .................... 101
Rack and clip ............................................................................................................................. 102
Water drain ................................................................................................................................ 103
Water drain hose ...................................................................................................................... 104
Water intake filter – changing the filter cartridge .............................................................. 104
Replacing the active carbon filter.......................................................................................... 105
Cleaning the ovens ................................................................................................................... 106
Oven air filter ............................................................................................................................. 107
Recommended maintenance and cleaning intervals ......................................................... 108
Malfunctions and Troubleshooting ...................................................................................... 111
8.1
8.2
8.3
9.
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2014-08-21
Fault remedies for instrument malfunctions ........................................................................ 111
Power failure scenario ............................................................................................................ 114
Replace main fuses .................................................................................................................. 115
Instrument Components and Specifications..................................................................... 116
9.1
9.2
Optional instrument components ........................................................................................... 116
Optional Accessories ............................................................................................................... 118
10. Garantie und Service ............................................................................................................ 124
11. Decommissioning and Disposal ......................................................................................... 125
12. Decontamination Certificate (master) ............................................................................... 126
Appendix 1 ......................................................................................................................................... 128
A1
Compatible reagents ................................................................................................................ 128
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
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1.
1.1
Important Information
Instrument Name
The full name of the device is HistoCore SPECTRA ST. The device is called
ca
SPECTRA ST to enhe Instructions for Use are well legible.
sure that the
1.2
Symbols and their meanings
Leica Biosystems GmbH assumes no liability for consequential loss or damage due to failure
to observe the following notes, particularly in relation to transportation and package handling,
and failure to observe the notes for handling the instrument carefully.
Symbol:
Symbol:
Symbol:
Symbol:
Symbol:
Title of the symbol:
Caution
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.
Title of the symbol:
Notes
Description:
This symbol indicates important information for the
user. The notes appear in a gray and are marked by
this symbol.
Title of the symbol:
Item numbers
Description:
Numbers and parentheses refer to item numbers in
the illustrations.
Title of the symbol:
Function keys
Description:
Function keys that must be pushed on the touchscreen or activated in the software are shown in
BOLD.
Title of the symbol:
Leica Biosystems GmbH company logo
Description:
Indicates the trademark of the company.
Leica HistoCore SPECTRA ST
DRAFT
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1.
Important Information
1.2
Symbols and their meanings (continued)
Symbol:
Symbol:
Symbol:
Symbol:
Symbol:
Symbol:
Title
tle of the symbol:
symb
Warning, hot surface
Description
Description:
Instrument
ument surfaces which becom
become hot during operation are marked with this symbol. Avoid direct contact
to prevent risk of burning.
Title of the symbol:
Manufacturer
Description:
Indicates the medical device manufacturer, as defined in EU Directives.
Title of the symbol:
Date of Manufacture
Description:
Indicates the date when the medical device was
manufactured.
Title of the symbol:
CE Compliance
Description:
The CE marking is the manufacturer's declaration
that the medical product meets the requirements of
the applicable EC directives.
Title of the symbol:
In vitro diagnostic medical device
Description:
Indicates a medical device that is intended to be used
as an in vitro diagnostic medical device.
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.
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
1.
1.2
Important Information
Symbols and their meanings (continued)
Symbol:
Symbol:
Title of the symbol:
WEEE Symbol
Symbo
Descript
Description:
The
he WEEE symbol, indicating sseparate collection for
WEEE - Waste of electrical and electronic equipment, consists of the crossed-out wheeled bin (§ 7
ElektroG).
Title of the symbol:
Alternating current
Description:
Symbol:
Title of the symbol:
PE terminal
Description:
Symbol:
Title of the symbol:
Earth (Ground) terminal
Description:
Symbol:
Symbol:
Symbol:
Title of the symbol:
Article number
Description:
Indicates the manufacturer's catalogue number so
that the medical device can be identified.
Title of the symbol:
Serial Number
Description:
Indicates the manufacturer's serial number so that a
specific medical device can be identified.
Title of the symbol:
Consult instructions for use
Description:
Indicates the need for the user to consult the instructions for use.
Leica HistoCore SPECTRA ST
DRAFT
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1.
Important Information
1.2
Symbols and their meanings (continued)
Symbol:
Title
tle of the symbol:
symb
ON (Power)
Description
Description:
The power supply is connected upon pushing the
power switch.
Title of the symbol:
OFF (Power)
Description:
The power supply is disconnected upon pushing the
power switch.
Title of the symbol:
Caution, possibility of electronic shock
Description
Instrument surfaces or areas which become energized during operation are marked with this symbol.
Therefore, direct contact is to be avoided.
Symbol:
Title of the symbol:
Caution: danger of crushing
Symbol:
Title of the symbol:
IPPC symbol
Description:
The IPPC symbol includes
 IPPC symbol
 Country code to ISO 3166, e.g. DE for Germany
 Regional identifier, e.g. HE for Hesse
 Registration number, unique number beginning
with 49.
 Treatment method, e.g. HT (heat treatment)
Title of the symbol:
Fragile, handle with care
Description:
Indicates a medical device that can be broken or
damaged if not handled carefully.
Symbol:
Symbol:
Symbol:
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
1.
1.2
Important Information
Symbols and their meanings (continued)
Symbol:
Symbol:
Symbol:
Symbol:
Symbol:
Title of the symbol:
Keep dry
Descript
Description:
Indicates
ndicates a medical device tha
that needs to be protected
from moisture.
Title of the symbol:
Do not stack
Description:
Stacking of the transport package is not allowed and
no load should be placed on the transport package.
Title of the symbol:
This way up
Description:
Indicates correct upright position of the transport
package.
Title of the symbol:
Temperature limit for transport
Description:
Indicates the temperature limits for transport to
which the medical device can be safely exposed.
Title of the symbol:
Temperature limit for storage
Description:
Indicates the temperature limits for storage to which
the medical device can be safely exposed.
Leica HistoCore SPECTRA ST
DRAFT
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1.
Important Information
1.2
Symbols and their meanings (continued)
Symbol:
Appearance:
Appearance:
Title
tle of the symbol:
symb
Humidity limitation for transport and storage
Description
Description:
Indicates
cates the range of humidity for transport and
storage to which the medical device can be safely
exposed.
Indication:
ShockWatch Impact Indicator - Red - 50G
Functional description
In the Shockwatch system, a precision glass tube
shows shocks or impacts that are above a specified
intensity through red coloration. Exceeding a defined
acceleration (g value) destroys the surface tension
of the liquid in the interior of the tube. This causes
the indicator tube to change color.
Indication:
Tilt indicator
Functional description
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 flows into the arrow-shaped indicator window and sticks there permanently. Improper
handling of the shipment is immediately detectable
and can be proven definitively.
When delivering the instrument, the recipient must check that the ShockWatch impact
indicator and tilt indicator are intact. The responsible Leica representative must be notified in the case that one or all indicators have been triggered.
10
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
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1.
1.2
Important Information
Symbols and their meanings (continued)
US/Canada only:
FCC ID: 2AAPD-SPECTRAST
IC: 12028A-SPECTRAST
This device complies with Part 15 of the FCC Rules an
and with Industry Canada
licence-exempt RSS standard(s).
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference
that may cause undesired operation.
Le prĂŠsent appareil est conforme aux CNR d'Industrie Canada applicables
aux appareils radio exempts de licence. L'exploitation est autorisĂŠe aux
deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radioĂŠlectrique
subi, mĂŞme si le brouillage est susceptible d'en compromettre le fonctionnement.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio
or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
 Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications made to this equipment not expressly approved by Leica Biosystems
Nussloch GmbH may void the FCC authorization to operate this equipment.
Leica HistoCore SPECTRA ST
11
DRAFT
2014-08-21
1.
Important Information
1.2
Symbols and their meanings (continued)
Japan only:
Japanese
nese Radio Law and Japanese Telecommunications
Te
Business Law Compliance.
This device is granted pursuant to the Japanese Radio Law
(電波法) and the Japanese Telecommunications Business
Law (電気通信事業法)
This device should not be modified (otherwise the granted
designation number will become invalid)
CSA Statement (Canada/USA)
The CSA test mark means that a product has been tested and
fulfills the applicable safety standards:
CAN/CSA-C22.2 No. 61010-1-04;
CAN/CSA-C22.2 No. 61010-2-010-04;
CAN/CSA-C22.2 No. 61010-2-101-04
Product is listed under Master Contract Number: 217333
12
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
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08-21
1.
1.3
Important Information
Instrument type
All information
tion
ion provided in these Instruc
Ins
Instruc-see applies only to the instruinstrutions for Use
ndicated on the title pa
page
ment type indicated
page. A
nameplate indicating the instrument serial number is attached at the left side of
the instrument. The accompanying Fig. 1
is provided as an example only and shows
a valid nameplate for this instrument.
The exact data of the different instrument versions are specified in
Chap. 3.2.
1.4
Qualification of personnel
Fig. 1
 The Leica HistoCore SPECTRA ST must only be operated by authorized personnel comprehensively trained in using lab reagents and their application in histology.
 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.
1.5
Intended use of instrument
The Leica HistoCore SPECTRA ST is a staining machine for laboratory applications. It is intended for the preparation of histological and cytological tissue samples.
The Leica HistoCore SPECTRA ST is also suitable for IVD (in vitro diagnostics).
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 SPECTRA ST carries out the specified staining steps automatically. Thus, 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.
Leica HistoCore SPECTRA ST
13
2.
Safety
2.1
Safety notes
DRAFT
2014 08 21
 The safety and caution notes in this chapter must be observed at all times. Be sure to
ad these notes even if you are already familiar with the operation
operat
read
and use of other
Leica
eica products.
prod cts
 The protective devices located on the instrument and the accessories must not be removed or modified.
 Only qualified service personnel authorized by Leica may repair the instrument and
access its internal components.
Residual risks
 The instrument has been designed and constructed with the latest state-of-the-art
technology and according to recognized standards and regulations with regard to
safety technology. Operating or handling the instrument incorrectly can place the
user or other personnel at risk of injury or can cause damage to the instrument or
property.
 The instrument may be used only as intended and only if all of its safety features are
in proper working condition.
 If malfunctions are to occur that can impede safety, the instrument must be put out of
operation immediately and the responsible Leica service technician must be notified.
 Only original spare parts and permitted original Leica accessories may be used.
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.
These Instructions for Use must be appropriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator‘s country.
The instrument's CE certificate can be found on the Internet at:
http://www.leicabiosystems.com
14
Instructions for Use V 0.5 RevC - 08/2014
2.1
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2014-08-21
2.
Safety
Safety notes (continued)
This instrument
ment has been built and tested in accordance with the safety requirements for elecment for measurement, control, and laboratory use. To main
trical equipment
maintain this condition and
e operation,
operation the user must observe all notes and warnings contained in these Inensure safe
structions for Use.
 You must make sure that any data loaded onto the instrument is free of viruses. No
anti-virus software is provided.
 The instrument is only suited for integration in a firewall-protected network. Leica
shall not assume any liability for errors due to integration in an unprotected network.
 ONLY technicians trained and permitted by Leica can connect a USB input device
(mouse/keyboard, etc.). This also applies to the network connection, which is to be
used only together with RemoteCare (service diagnostics) and/or a LIS connection.
In the interest of specimen safety, the SPECTRA ST indicates when it is necessary for
the user to interfere using text messages and audible signals. Therefore, the SPECTRA
ST staining machine requires that the user is within hearing distance during operation.
The product uses a class 1 laser source.
Caution, laser radiation! Do not look into the beam! This can cause injury to the conjunctiva.
LASER RADIATION - DO NOT
STARE INTO BEAM
EN 60825-1: 2007
P<1 mW, O= 630 to 670 nm
Pulse duration = 500 Îźs
Class 1 laser product
Leica HistoCore SPECTRA ST
15
2.
Safety
2.2
Warnings
DRAFT
2014-08-21
Warnings on the instrument
strumen
strument
The safety devices
iinstalled
t ll d iin thi
this iinstrument
t bby th
the manufacturer
f t
only
l constitute the basis
for accident prevention. Operating the instrument safely is, above all, the responsibility of the
owner, as well as the designated personnel who operate, service or repair the instrument.
To ensure trouble-free operation of the instrument, make sure to comply with the following
instructions and warnings.
Please note that electrostatic discharges can result due to direct or indirect contact with the
SPECTRA ST.
Markings on the instrument surface showing the warning triangle indicate that the correct operating instructions (as defined in these Instructions for Use) must be followed
when operating or replacing the item marked. Failure to adhere to these instructions
may lead to accidents causing personal injury and/or damage to the instrument or accessories or destroyed, unusable specimens.
Certain surfaces of the instrument are hot during operation under normal conditions.
They are marked with this warning sign. Touching these surfaces without suitable safety measures can cause burns.
Safety notes on the instrument itself, which are marked with a round prohibitory sign,
indicate that the situation described by the symbol must be avoided and the correct operating instructions (as defined in these Instructions for Use) must be followed when
operating the instrument marked. Failure to adhere to these instructions may lead to accidents causing personal injury and/or damage to the instrument or accessories or destroyed, unusable specimens.
16
Instructions for Use V 0.5 RevC - 08/2014
2.2
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2014
08 21
2.
Safety
Warnings (continued)
Warnings - Transport
sport and installation
 The instrument must only
l be
b transportedd in
i an upright position.
 The empty weight of the instrument is 185 kg; therefore, four qualified persons are required to lift or carry the instrument!
 Use non-skid gloves to lift the device!
 Leica recommends commissioning a transport company to transport, install or (where
applicable) relocate the instrument.
 Place the instrument on a sturdy laboratory bench and adjust it to a horizontal position.
 Prevent the instrument from being exposed to direct sunlight!
 Only connect the instrument to a grounded power socket. Do not interfere with the
grounding function by using an extension cord without a ground wire.
 Exposure to extreme temperature changes between storage and installation locations
and high air humidity may cause condensation inside the instrument. If this is the
case, wait at least two hours before switching on the instrument.
 The instrument must only be installed at the area of use with and under direction of
Leica-trained staff. This also applies to the potential transport to a new area of use.
We recommend using personnel trained by Leica to recommission the instrument.
Warnings – Handling reagents
 Take care when handling solvents!
 Always wear protective clothing suitable for laboratory use, as well as rubber gloves
and safety goggles when handling the chemicals used in this instrument.
 The installation site must be well-ventilated. Alternatively, the instrument can be
connected to an external exhaust air extraction system. The chemicals to be used in
the SPECTRA ST can be easily flammable and hazardous to health.
 Do not operate the instrument in rooms with an explosion hazard.
 When disposing of spent reagents, observe the applicable local regulations and the
waste disposal regulations of the company/institution in which the instrument is being operated.
 Reagent cuvettes must always be filled outside of the instrument in compliance with
the safety information.
Leica HistoCore SPECTRA ST
17
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2014-08-21
2014
08 21
2.
Safety
2.2
Warnings (continued)
Warnings – Operating
ing
ng the instrume
instrument
 The instrument may be operated by trained laboratory personnel only. It must only be
operated for the purpose of its designated use and according to the instructions contained in these Instructions for Use. Antistatic protective clothing made from natural
fibers (e.g. cotton) should be worn when working with the instrument.
 In the event of an emergency, switch off the power switch and unplug the instrument
from the power supply (circuit breaker in accordance with EN ISO 61010-1).
 There is a fire hazard if work with an exposed flame (e.g. Bunsen burner) is carried
out in the direct vicinity of the instrument (solvent vapors). Therefore, keep all ignition
sources at least 2 meters away from the instrument!
 Be absolutely certain to operate the instrument either with the active carbon filter,
technical ventilation system and an exhaust hose, as even when the instrument is
used according to its designated use, solvents arise that are both hazardous to health
and inflammable!
 For the instrument fume control, Leica recommends a delivery volume of 50 m3/h and
an air exchange rate of 8 (25 m3/m2h) in the lab.
 Opening the hood when one or more staining program(s) are active causes delays
in the respective processing steps since no transport movements take place for this
time frame. This can result in changes to the staining quality.
 Make sure to keep the hood closed if the staining programs are active. Leica assumes
no liability for loss of quality for staining programs caused by opening the hood during the staining process.
 CAUTION when closing the hood: Crushing hazard! Do not reach into the swivel range
of the hood!
18
Instructions for Use V 0.5 RevC - 08/2014
2.2
DRAFT
2014-08-21
2014
08 21
2.
Safety
Warnings (continued)
Warnings – Operating
rating the instrument (continued)
 No liquid may reach behind covers and in columns when working and cleaning. This
also applies for transport arms.
 CAUTION for programs that start with an oven step! In this case, the load station from
which the specimen slide is removed with the transport arm must NOT be filled with
a flammable reagent (e.g. xylene, xylene substitute or alcohols). The oven temperature can be up to 70 °C. This can result in the reagent igniting and can cause damage
to the instrument and specimens.
 CAUTION when filling the heated reagent cuvettes. Flammable reagents (e.g. xylene,
xylene substitute or alcohols) must not be added to the heated reagent cuvettes.
Warnings – Maintenance and cleaning
 Before any maintenance, switch off the instrument and unplug it from power supply.
 When using cleaners, please comply with the safety instructions of the manufacturer
and the laboratory safety regulations.
 The plastic reagent cuvettes of the rinsing water and reagent stations can be cleaned
in a dishwasher at a maximum temperature of +65 °C. Any standard cleaning agent
for laboratory dishwashers may be used. Never clean the plastic reagent cuvettes at
higher temperatures since it can cause the reagent cuvettes to become deformed!
 Do not use any of the following for cleaning the outside surfaces of the instrument:
alcohol, detergents containing alcohol (glass cleaners), abrasive cleaning powders,
solvents containing acetone, ammonia, chlorine, or xylene!
 Wear suitable protective clothing when cleaning the instrument (lab coat and
gloves). Clean the hoods and housing using mild commercial, pH-neutral household
cleaners. The finished surfaces are not resistant to solvents and xylene substitute!
Leica HistoCore SPECTRA ST
19
DRAFT
2014-08-21
2.
Safety
2.3
Safety features on the instrument
As soon as the
e hood of the instrument is opened, the movements of the transport arms are
orizontal
rizontal plane (x and y-axis) for safety reasons to eliminate specimen damage
stopped in a horizontal
due to collisionn with moving parts.
part
 Make sure to keep the hood closed if the staining programs are active. Leica assumes
no liability for loss of quality for staining programs caused by opening the hood during the staining process.
 Opening the hood when one or more staining program(s) is/are active causes delays
in the respective processing steps since no transport movements take place for this
time frame. This can result in changes to the staining quality.
20
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
3.
3.1
Instrument Components
Com
Comp
and Specifications
Standard delivery—packing list
Qty
Designation
ation
on
Order No.
A ST basic instrum
SPECTRA
instrument
14 0512 47567
Power cable
country-specific
46
Reagent cuvettes, assembly, including reagent cuvette cover
14 0512 47086
Water flow cuvettes, assembly
14 0512 47087
O-rings 7x2, for water flow cuvette connecting piece
14 0253 47088
Sanitation and water supply equipment accessories:
Outlet hose, length: 2 m
14 0475 35747
Inflow hoses, Ø 10 mm, length: 2.5 m
14 0474 32325
Pressure hose, 1.5 m extension
14 0512 49334
Y piece
14 3000 00351
Double nipple G3/4 G3/8
14 3000 00350
Water filter housing
14 0512 49331
Filter cartridge
14 0512 49332
Bushing G 3/4
14 3000 00360
Exhaust hose, 2 m
14 0475 35762
Active carbon filter
14 0512 47131
Rack for 30 specimen slides (3 pcs. per package)
14 0512 52473
Clip for rack for 30 specimen slides (yellow, 3 pcs. per package)
14 0512 52576
Clip for rack for 30 specimen slides (dark blue, 3 pcs. per package)
14 0512 52478
Clip for rack for 30 specimen slides (red, 3 pcs. per package)
14 0512 52480
Clip for rack for 30 specimen slides (white, 3 pcs. per package)
14 0512 52484
Instructions for Use, printed (German/English, with
Language CD 14 0512 80200)
14 0512 80001
Leica HistoCore SPECTRA ST
21
DRAFT
2014-08-21
3.
Instrument Components
ts and Specification
Specifications
3.2
Technical Data
Nominal supply voltages:
ages:
es:
100-240
00-240 V AC +10 %
Nominal frequency:
50/60
0/60 Hz
Power draw:
1350 VA
Fuses:
2 x T16 A H 250 V AC
IEC 1010 classification:
Protection class 1
Pollution degree:
Overvoltage category:
II
Fresh water connection:
Hose material:
PVC
Hose length:
2500 mm
Connecting piece:
G3/8
Inner diameter:
10 mm
Outer diameter:
16 mm
Internal pressure: Minimum:
2 bar
Maximum:
6 bar
Required flow rate:
Min. 1,7 l/minute
Required water quality:
Type 1, ISO 3696
Waste water connection:
Hose length:
2000 mm/4000 mm
Inner diameter:
32 mm
Outer diameter:
36.8 mm
Exhaust air:
Hose length:
2000 mm
Inner diameter:
50 mm
Outer diameter:
60 mm
Exhaust performance:
27.3 m3/h
22
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
3.
3.2
Instrument Components
Com
Comp
and Specifications
Technical data (continued)
Exhaust extraction:
on:
Active
ctive carbon filter and exh
exhaust hose for connecting with an external exhau
exhaust system
Heat emission:
1350 J/s
A-weighted noise level:
< 70 dB (A)
International protection class:
IP20
Sockets
1 x RJ45 Ethernet (rear):
RJ45 - LAN (external data management)
1 x RJ45 Ethernet (front):
Only for service purposes
2 x USB 2.0:
5 V/500 mA (service & data storage)
When using an external uninterruptible power supply (UPS), it should be designed for a
capacity of at least 1350 VA and secure operation over a time frame of at least 10 minutes.
Ambient conditions:
Operation:
Temperature:
+18 °C to +30 °C
Relative humidity:
20 % to 80 %, non-condensing
Operating elevation:
Up to a max. of 2000 m above sea level
Storage:
Temperature:
+5 °C to +50 °C
Relative humidity:
10 % to 85 %, non-condensing
Transport:
Temperature:
-29 °C to +50 °C
Relative humidity:
10 % to 85 %, non-condensing
Dimensions and weight
Dimensions (length x depth x height):
Hood closed: 135.4 x 78.5 x 58.5 cm
Hood open: 135.4 x 78.5 x 94.3 cm
Empty weight (without reagents and accessories): 185 kg
Leica HistoCore SPECTRA ST
23
DRAFT
2014-08-21
2014
08 21
3.
Instrument Components
ts and Specification
Specifications
3.3
Overview
Front view
7a/b
Insert for active carbon filter
Read-in area for Leica reagents
7a USB sockets (2 pcs.),
Input drawer
7b Service access
Output drawer
ON/OFF switch
Screen holder with interior lighting
Lid
Fig. 2
Screen with user interface
The service access (7b, Fig. 2) may only be used by service technicians certified by Leica!
The cover of the read-in area (2, Fig. 2) may only be removed by a service technician certified
by Leica.
24
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014 08 21
2014-08-21
3.
3.3
Instrument Components
Com
Comp
and Specifications
Overview(continued)
Rear view
Network connection (RemoteCare/LIS)
Power supply
Waste outlet
Running water connections
Exhaust air connection
Leica HistoCore SPECTRA ST
Fig. 3
25
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2014 08 21
2014-08-21
3.
Instrument Components
ts and Specification
Specifications
3.3
Overview(continued)
Inside view
10
Fig. 4
26
Left transport arm
Transfer station for SPECTRA CV (optional)
Specimen slide reader module
Right transport arm
Load station, 5 pcs.
Rinsing water stations, 6 pcs.
Dry transfer stations, 2 pcs.
Heated reagent stations, 4 pcs. (optional)
Unload station, 5 pcs.
10
Drying oven stations, 6 pcs
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014 08 21
4.
4.1
Installation
In
and Starting Up
Installation site requirements
 Installation
nstallation and leveling are carried out as part of the instrum
instrument installation by personnel authorized by Leica only!
 Use 4 qqualified
device;
alified persons when
hen lifting the de
ice grab under
nder tthe frame at all corners
and lift evenly.
 It must be ensured that there is a mostly vibration-free floor and sufficient clear space (approx. 1.10 cm) above the laboratory bench to allow unobstructed opening of the lid.
 Condensation water may form in the instrument if there is an extreme difference in temperature between the storage location and the installation site and if air humidity is high at the
same time. A waiting time of at least two hours must be observed each time before switching
on. Failure to comply with this may cause damage to the instrument.
 Stable, exactly horizontal and level laboratory bench at least 1.40 m wide and 0.80 m deep.
 The counter area must be designed for handling loads of at least 150 kg/m2, vibration-free
and level.
 Fume hood at a max. 2.0 m distance from the instrument.
 The instrument is suitable for operation in indoor areas only.
 The operating location must be well-ventilated and have an air exhaust.
 A running water connection must be available at a maximum distance of 2.5 m. This connection must also be easily accessible after installing the instrument.
 A waste water connection must be available at a maximum distance of 2 m. This connection
must be connected to the instrument with constant outlet hose slope.
 A connection to an external exhaust system, a technical room ventilation system and
an integrated exhaust system with an active carbon filter reduce the concentration of
solvent vapor in the room air. The active carbon filters must be used for connecting to
an external exhaust system as well. Compliance with this is mandatory.
 The instrument operator bears responsibility for complying with workplace limits in
accordance with the hazardous substances ordinance and the measures necessary
for this, including documentation.
 A grounded power supply socket must be available at a maximum distance of 3 m.
Leica HistoCore SPECTRA ST
27
DRAFT
2014-08-21
4.
Installation and Starting
ng Upp
4.2
Running water connection
There iss the option of choosing between two connection variants.
ee Chap. 6.5).
The device must be programmed to the connection variant used (see
The following installation instructions apply for both types of connections:
 Remove the rinsing water supply hose (7) from the packaging, being careful of the two
gaskets (4).
 Insert one gasket (4) into the screw connection (6) on the instrument.
 Keep other gaskets as replacements.
 Insert the filter screen (3), as shown in Fig. 5, into the retaining ring (5) that is fastened to
the water tap. Do not use another gasket since the filter screen acts as a sealing simultaneously.
Fig. 5
28
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
4.
In
Installation and Starting Up
4.2.1 Joint connection of all 6 rinsing water stations
If all water flow
low cuvettes (6 running water stations) are to be connected to a joint running water
(see Fig. 66)) are used at the same ttime:
connection,, both supply hoses (see
Fig. 6
Rinsing water supply hose 1 (2.5 m)
Order No.: 14 0474 32325
Pressure hose (1.5 m)
Order No.: 14 0512 49334
Rinsing water supply hose 2 (2.5 m)
Order No.: 14 0474 32325
Y piece
Order No.: 14 3000 00351
Filter
Order No.: 14 0512 49331
Leica HistoCore SPECTRA ST
29
4.
DRAFT
2014-08-21
Installation and Starting
ngg Upp
4.2.2 Combined connection 4+2 rinsing water stations
If the main connection
nection (4 rinsing water stations) is to be connected to fresh water and the secction
tion (2 rinsing water stations) is to be connected to a supp
ondary connection
supply in the laboratory
with distilled orr desalinated water (aqua dest.
in accordance
dest or demineralized water),
water) proceed
pro
with the following connection diagram:
Fig. 7
30
Rinsing water supply hose 1 (2.5 m)
Order No.: 14 0474 32325
Pressure hose 3 (1.5 m)
Order No.: 14 0512 49334
Rinsing water supply hose 1 (2.5 m)
Order No.: 14 0474 32325
Filter
Order No.: 14 0512 49331
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
4.
In
Installation and Starting Up
4.2.3 Wastewater connection
 The instrument
rument
ument has a passive wastewater outflow. The lab outflow siphon
si
must therefore be
5 cm under the wastewater connection of the instrument.
instr
located att least 50
The outlet hose (1, Fig. 8) must be routed at a constant slope and must not be elevated.
Fig. 8
Leica HistoCore SPECTRA ST
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2014-08-21
4.
Installation and Starting
ng Upp
4.3
Electrical Connection
Use only
ly the power cable provided, which is intended for the local ppower supply.
Before connecting the instrument to the power supply, make sure that the main switch
on the front right side of the instrument is in the OFF ("0") position.
 Connect the power cable to the power input
socket on the rear panel of the instrument
(Fig. 9).
 Plug the power plug into a grounded power
socket.
Fig. 9
 Switch on the power switch (1, Fig. 10).
 After a short period of time, the operating
switch lights up orange (2, Fig. 10); once the
software has completely started, it lights up
red and the instrument is in standby mode.
 The operating switch can then be operated
(see Chap. 4.5).
Fig. 10
32
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2014-08-21
201
4.
In
Installation and Starting Up
4.3.1 Using an external uninterruptible power supply (UPS)
An interruption of the staining process can be avoided in the
event
nt of a temporary power failure by connecting a batterybuffered uninterruptible power supply (UPS). The UPS should
enable an output of at least 1350 VA for the duration of 10 minutes. The UPS must be designed for operating voltage at the
installation location. The connection is carried out by connecting the SPECTRA ST power cable to the UPS power output
socket. The UPS is connected to the power socket in the lab.
Fig. 11
4.4
The UPS power cable must always remain in the
power socket in the lab, even in the event of a power
outage. Otherwise grounding of the instrument cannot be ensured!
Exhaust air connection
 Connect one end of the exhaust hose (1, Fig. 12) to the exhaust port (2, Fig. 12) on the top
side of the instrument. Connect the other end to an exhaust air device installed in the lab.
Fig. 12
Leica HistoCore SPECTRA ST
A connection to an external exhaust system
and an integrated exhaust system with an
active carbon filter reduce the concentration
of solvent in the room air and must be used.
The cuvettes must be covered when not using the instrument to prevent the unnecessary evaporation of the reagents.
When working with hazardous materials,
compliance with the workplace limit values
according to the ordinance on protection
from hazardous substances must be inspected by the operator.
33
DRAFT
4.
Installation and Starting
ng Upp
4.5
Switching the instrument on and off
The instrument must be connected to a grounded power socket. For additional
electrical
fuse protection,
residual current circuit
rotection, connecting the SPECTRA ST to a socket with a res
breaker
aker (RCCB) is recommended.
recommended
 Switch the power switch on the front right side at the bottom of
the instrument to ON ("I"). (See 1, Fig. 13)
 A few seconds after switching on the power switch, the operating switch is illuminated in orange (Fig. 14). The software's start
process ends when the operating switch illuminated in red.
Fig. 13
Fig. 14
Fig. 15
Pushing the operating switch in the orange phase does
not start the instrument.
 To start the instrument, press the operating switch illuminated
in red.
 During initialization, a verification of all stations ("fill level scan")
is carried out automatically.
 The operating switch is illuminated in green whenever the instrument is ready to start.
 After completing the initialization phase, the main menu appears
on the screen (see Fig. 15).
Switching off the instrument
 To switch the instrument into standby mode (e.g. overnight), press
the operating switch. It then illuminates in red.
 For cleaning and maintenance, also switch off the instrument on
the power switch (see 1, Fig. 13).
During the instrument setup or if no reagents are added, non-filled stations are identified and highlighted on the screen (see Chap. 6.2.2)
If using the oven is programmed in the staining program as the first step, the program
can be marked "not startable" after switching on the instrument since the oven has not
yet reached operating temperature. As soon as the operating temperature is attained,
the program is displayed as startable.
34
Instructions for Use V 0.5 RevC - 08/2014
5.1
DRAFT
2014-08-21
5.
Operation
User interface – overview
 The SPECTRA
CTRA ST is programmed and operated using a color touchs
touchscreen. The screen appears ass follows after switching on if there is no staining process (p
(program) running.
Fig. 16
Status bar
Button for the SPECTRA CV process display
Process status display
Input drawer status display
Output drawer status display
Main menu (see Chap. 5.5)
Leica HistoCore SPECTRA ST
35
DRAFT
2014 08 21
5.
Operation
5.2
Status bar elements
Fig. 17
36
Current date
Local time
The "Remote Care access" symbol indicates that this instrument is connected to the
Leica Remote Care Service via a network connection.
The "process" symbol indicates that staining processes are currently active.
This "user" symbol indicates that the instrument is in user mode, which enables simplified operation of the instrument without a password.
The operation of this instrument in "Supervisor Mode" is displayed by this symbol. This
mode provides additional operation and adjustment options for trained staff. Access
to this mode is password-protected.
If warnings and notes are displayed during operation, the symbol depicted appears.
Pressing this symbol allows the last 20 messages to be called up again.
If alarms and error messages are displayed during operation, this alarm symbol appears.
Pressing this symbol allows the last 20 messages to be called up again.
Instructions for Use V 0.5 RevC - 08/2014
5.3
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5.
Operation
Process status display
Fig. 18
 All slide racks located in the process (3) are displayed in the main window (Fig. 18).
To display an active staining process, the upper part of the clip is displayed symbolically in the respective color (3, Fig. 18). If the number of racks in the process exceeds
the maximum that can be displayed in the main window (max. 9), you can scroll through
the display area vertically using the keys (1, Fig. 18). If one of the buttons is grayed out,
it is disabled and there are no other elements in an area that is not shown.
 The title bar of the main window (2, Fig. 18) indicates the instrument type [SPECTRA ST] and
lists the currently bootable staining programs with the defined abbreviations and the color
assigned to the slide racks.
Leica HistoCore SPECTRA ST
37
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201 08
2014-08-21
8-21
5.
Operation
5.3
Process status display (continued)
Each ongoing stai
staining process is illustrated by a rac
rack clip symbol. It is
shown
in
i the
th same color as the actual
rack clip. Various information is displayed on the clip symbol (see Fig. 19).
Fig. 19 shows the status display on the
SPECTRA ST without connected robotic coverslippers. For displaying the
status display in workstation operation, see Chap. 6.7.5.
Fig. 19
38
Abbreviation of the program
Current position of the slide rack in
the instrument
Progress display of the entire staining process
Estimated remaining time at the
current station (hh:mm)
Remaining time until the end of the
program (hh:mm)
If the SPECTRA ST staining machine is connected to the SPECTRA CV robotic coverslipper permanently, the combination of both instruments
represents an instrument unit (workstation).
This enables an interruption-free workflow from
the staining process up to the removal of the finished cover slipped slides.
The current process status of both instruments
can be shown on the screen of the SPECTRA ST
staining machine.
Pressing the "SPECTRA CV" (3, Fig. 20) or "SPECTRA ST" button allows you to change between
the status displays of the staining machine and
robotic coverslipper.
The progress display is divided into two sections
in workstation mode with a connected SPECTRA
CV. The upper section displays the progress in
the stainer.
The lower area shows the coverslipping progress in the SPECTRA CV (see Chap. 6.7.5).
Instructions for Use V 0.5 RevC - 08/2014
5.4
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2014-08-21
08 21
5.
Operation
Displaying the drawers
The lower area
rea of the main window illustrates the status of the input and
an output drawers.
Fig. 20
 The stations displayed using the direction of the arrow pointing into the instrument (1, Fig. 20)
symbolize the input drawer. The stations displayed using the direction of the arrow pointing
out of the instrument (2, Fig. 20) symbolize the output drawer with five positions each.
 The respective drawer is opened or closed automatically by pressing the drawer button (4
or 5, Fig. 20).
 The device automatically recognizes if slide racks are inserted or removed when the drawer
is closed.
 The slide racks located in the input or output drawer are shown on the screen with the
respective slide rack handle color and the assigned program abbreviation.
 Available positions are shown in white and without a label.
Leica HistoCore SPECTRA ST
39
DRAFT
2014-08-21
5.
Operation
5.5
Main menu-overview
The main menu
u is located on the left side of the display ((see
see Fig. 18)
18),
), which is divided into secbed below. This menu is visible in all submenus and allows switching
tions as described
to another
submenu at anyy time.
time
The "process status display" displays the current status of all racks
located in the process. Here, the respective clip of the rack is displayed
symbolically with the respective color.
This display shows the standard display.
The "bathlayout" displays the top view of all stations within the instrument. The individual reagent stations are displayed with reagent names,
station numbers and slide racks located in the process.
After activating the "program list", all staining programs available in the
instrument are displayed in list form. The menu enables re-entering and
changing staining programs, their prioritization and the creation of the
bathlayout.
After activating the "reagent list", all previously entered reagents are
displayed in list form. The menu enables the modification or re-entering
of staining reagents, e.g. for integrating new staining programs. The
reagents must be entered before creating the program.
Basic settings can be configured in the "Settings" menu. The language
version, date and time as well as oven temperature and other parameters
can be adjusted to the local requirements here.
In the "User Settings" menu, a password can be set up to prevent
modifications to the programs and reagent lists by unauthorized persons
("Supervisor mode"). However, the instrument can be used without a
password in "User Mode".
40
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014 08 21
5.
Operation
5.5.1 The keyboard
A keyboard
eyboard appears (Fig.
Fig. 221) for required entries (e.g. for prog
programming, creating prorams or password entry). It is operated using the touch screen.
grams
keyboard
display depends on the config
configured
language.
Note that the ke
board displa
red lang
1 Title bar
Fig. 21
8 Cancel (entries are not saved!)
2 Input field
3 Delete most recently entered character
4 Confirmation
5 Move cursor to left or right
9 Upper and lowercase (holding the button
activates caps lock, displayed by coloring
the button red. Pressing again re-activates
lowercase.)
6 Space key
7 Special character toggle button (Fig. 22)
Leica HistoCore SPECTRA ST
41
5.
Operation
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2014-08-21
5.5.1 The keyboard (continued)
Special character
cter keyboard
Fig. 22
Other special characters
Fig. 23
 To enter a special character or umlaut, etc. not included in the special character keyboard
(Fig. 22), hold the corresponding normal button on the keyboard.
 Example: Holding the normal character "a" opens the selection options displayed in Fig. 23.
 Select the required character from the new single-line keyboard by pressing it.
The following lengths are possible for passwords and designations:
 Reagent names: max. 24 characters / reagent abbreviations: max. 10 characters
 Program names: max. 24 characters / program abbreviations: max. 10 characters
 Passwords: min. 4 to max. 10 characters
42
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5.6
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2014-08-21
5.
Operation
User settings
This menu can be used to configure the appropriate acces
access level. A distinction is
between
made betwe
  
 
        
          
Fig. 24
Standard user:
The standard user does not need a password and can use the completely
configured instrument for all routine applications. It is not possible for this user
group to modify programs and settings.
Leica HistoCore SPECTRA ST
43
DRAFT
2014-08-21
5.
Operation
5.6
User settings (continued)
Supervisor:
pervisor:
Supervisors
user, but can
pervisors have the same access options as the standard us
also
functions. Therefore,
o create programs and perform the instrument setup functi
supervisor access is password-protected.
The password configured at the factory should be changed during the initial
setup.
To activate supervisor mode, proceed as follows:
Fig. 25
 Press the "Supervisor" button (1, Fig. 24).
 Then, a keyboard (Fig. 25) is displayed which
can be used to enter the password.
 The entry is finished by hitting "OK" and the
entered password is checked for validity.
 The current user status is displayed with the
respective symbol in the status bar on the
top right.
To change the password, press the "Change password" (2, Fig. 24) button and enter the
old password. Then, enter the new password twice using the keyboard and confirm by
hitting "OK".
A password must have at least 4 characters and may have up to 10 characters.
44
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2014-08-21
5.
Operation
Basic settings
Service technicia
technician:
The service technician can access system files and carry out basic settings and
ttests.
Access to this service menu is only possible for technicians trained by
Leica and certified for this instrument type.
Changing the settings, for example when setting up the instrument for the
first time, is only possible in supervisor mode (see Chap. 5.6).
Touching the gear symbol (1, Fig. 26) opens the "Parameters"
menu (Fig. 26). Basic instrument and software settings can
be configured in this menu.
 Touching one of the symbols (e.g. 2, Fig. 26) selects it and
labels it with a red frame.
 The respective settings window is displayed in the right
area of the screen.
 The individual submenus are described below.
Fig. 26
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5.7.1 Language settings
 The
he language selection menu is displayed by pushing the symbol for the lan26).
languages installed in
guage ((2,
2, FFig. 26
6). This menu contains an overview of all la
the instrument and allows the desired display language to be selected.
 Select the desired language and confirm by hitting "Save".
 The screen display and all messages and labels are displayed immediately in
the currently configured language.
A Leica service technician can add other languages using Import (see
Chap. 5.7.7).
5.7.2 Country-specific settings
Basic display settings can be carried out in this menu.
Unit of temperature:
 Configure the temperature unit (1, Fig. 27) in
Celsius or Fahrenheit. To do so, position the
slider to the desired unit.
Time format:
 The time display (2, Fig. 27) can be changed
from a 24-hour display to a 12-hour display
(a.m. = morning/p.m. = afternoon) using the
slider.
Date format:
 Configure the date display (3, Fig. 27) to international, ISO or US format by pushing the
corresponding radio button next to the sample
format.
 The activated setting is labeled by a red border
(4, Fig. 27)
 Pushing the "Save" button saves the settings
Fig. 27
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5.7.3 Date and time
The current date and local time can be configured in thi
this menu by rotating the
individual rollers
rollers.
In the 12-hour display, a.m. (morning)
and p.m. (evening) is displayed under
the hour digits to enable a correct setting.
The time and date settings cannot deviate more than 24 hours from the system time configured at the factory.
 Pushing the "Save" button saves the settings
Fig. 28
5.7.4 Alarm and signal tones
This menu can be used to select the alarm and signal tones and adjust the volume. The current setting for alarm and signal tones is displayed after calling up
the menu.
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5.7.4 Alarm and signal tones (continued)
Fig. 29
Alarm type 1 - Note:
Signal tones are issued if a notification is displayed on the screen. You can select from a list of
6 sounds. To change the settings, press the "Edit" button (3, Fig. 29) .
Alarm type 2 - Error:
Alarm sounds are output if a warning or error message is displayed on the screen. This requires
immediate intervention from the user. You can select from a list of 6 sounds. To change the settings, press the "Edit" button (4, Fig. 29).
 The volume setting for alarm sounds is adjusted using the "Volume" roller. Six different
sounds are available for the alarm types. The "Test" button (7, Fig. 29) can be used to listen
to the respective sound.
 Pressing the "Save" (8, Fig. 29) button saves the settings. The "Cancel" button (6, Fig. 29) is
used to close the selection window without applying the settings.
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5.7.5 Setting the oven
The temperature of the oven and its operation mode can be cconfigured in this menu.
The current oven settings are displayed after calling up the menu.
Changing the oven temperature will always have a potential impact on the
staining result.
Fig. 30
Temperature:
Rotating the roller can configure the target temperature of the oven from 40 °C to 70 °C in 5 ° increments.
Operation mode:
For the operation mode, you can choose between:
 Heating the oven when starting a product
("Program start") or
 Starting the oven when switching on the instrument ("Permanent").
 The slider can be brought to the corresponding
position to change the settings.
 Settings are saved by pressing the "Save"
button.
The password-protected user mode "Supervisor" is required to save the changes. In the
simple user mode, the "Save" button is shown in gray and is inactive.
 Validated Leica programs can be operated both with and without an oven step (see
Chap. 5.9.2). If an oven step is activated in a validated Leica program, the oven temperature cannot be changed for all other programs and remains preset at 70 °C.
 We recommend using "Permanent" as a setting to prevent repeated waiting times
caused by heating the oven.
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5.7.6 Movement speed - up/down movement (agitation)
This
is menu is used to configure the movement speed of the retaining frame for
de racks. The slide rack clips are on the retaining frame wh
slide
which moves back and
forth
(agitation).
rth in the staining process (agitation
(agitation)
The current setting is displayed after calling up the menu.
Agitation helps stir the added reagents during ongoing staining processes.
Speed:
 Rotating the "Speed" roller can be used to
configure the agitation frequency in 5 steps (0=
agitation disabled, 5= highest speed). Higher
values mean a higher agitation frequency.
 Settings are saved by pressing the "Save"
button.
Fig. 31
The agitation speed for user-defined programs can only be changed if no validated Leica program is active. In this case, the roller is displayed in black and active. Agitation is
the default for validated Leica programs and cannot be changed. The roller is grayed out
and inactive.
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5.7.7 Data management
In this menu, the data, settings and event logs (log files) ccan be exported. A USB
memory stick connected to one of the USB sockets on the front side of the instrument ((7a,
7a Fig
FFig. 2)) is required for all exports and imports (exc
(except for remote software
updates).
User export (1, Fig. 32)
The "User export" function is used to save
various information on a connected USB
memory stick (see 7a, Fig. 2). The following
files are transferred:
 All defined programs and reagent lists as
a packed and encrypted Zip file
 Event log (of the last 30 working days)
 RMS information in CSV format
User-defined programs and the reagent list
can be transfered to another SPECTRA ST by
the "Import" function (3, Fig. 32).
Fig. 32
After successfully setting up the instrument, we recommend exporting the data to be
able to access it if the instrument has to be set up again.
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5.7.7 Data management (continued)
Fig 32
332))
2 Fig.
2,
Service exportt ((2,
Along with the files named below, this function also saves technical infor
information for error log
i d ffor ttechnical
h i l iinstrument
t di
ti
analysis and is required
diagnostics.
The data is stored encrypted and cannot be read out on a PC.
Two files are also stored that are merged into a zip file. These files are packed in a ZIP folder
unencrypted. They can be read out and used by a service technician authorized by Leica:
Error log (of the last 30 days)
Content of the ZIP folder:
1. Run-Log-Datei mit allen Statusmeldungen in der eingestellten Sprache
2. Information from the reagent management system (RMS), in CSV format.
Import (3, Fig. 32)
The password-protected user mode "Supervisor" is required for importing.
This function enables the data import of the encrypted program and reagent list, additional
validated Leica programs and additional language packages from a connected USB memory
stick. This data can also be used to equip another SPECTRA ST with the same data using the
Export/Import function.
 To do this, insert the USB memory stick with the previously exported data into one of the
USB sockets on the front side of the instrument.
 Then, select the "Import" function. The data is scanned.
When importing data from a USB memory stick, all programs and reagents previously
located on the instrument are overwritten.
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5.7.7 Data management (continued)
Software update
pdate (4,
4, Fig.
g. 32
32)
2)
Software updates
pdates and additional language packages may only be run by a service technician
i e.g. ffor iinstalling.
t lli
authorized bby LLeica,
Lab-specific settings are not deleted when updating the software for the SPECTRA ST.
Remote software update (5, Fig. 32)
This function makes it possible to update the software using a connected network. To do so,
the instrument must be integrated into the Leica Remote Care maintenance and diagnostic
system.
 The new software version is loaded automatically as soon as it is available for this instrument. Once the loading procedure has concluded, the button (5, Fig. 32) is shown in black
and is activated.
 Pressing the "Remote software update" button starts the automatic update process when
the instrument is idle.
The user will be notified about an available software update via a message.
The SPECTRA ST software is updated; lab-specific settings are not deleted.
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5.7.8 Service access
This
his menu gives Leica authorized service technicians acces
access to technical funcons
ns for diagnostics and repairs to the SPECTRA ST.
tions
Access to the service software is
locked for all other user groups.
Fig. 33
5.7.9 Event view
A separate log file is created for each day that the instrument was switched on.
This file can be called up by selecting the "DailyRunLog" file in the event view.
 In the event view, an event log can be selected
from a list of available logs and called up by
hitting the "Open" button.
The file name is supplemented by the
respective creation date in ISO format,
which makes it easier to organize. The
file is created in the configured language.
Fig. 34
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5.7.9 Event view (continued)
 Alll event entries

ent
begin with a time
(1, Fig.
Fig
ig 37), which indicates
stamp (1,
the
e date and time when the entry
was created.
 You can scroll up and down in the list
and the log file using the arrow keys
(2, Fig. 35).
Fig. 35
5.7.10 Network settings
This menu allows you to set the network parameters for connecting to a network.
Data can be transferred to a lab information system (LIS) via this network.
Leica service organizations can access the instrument's technical data via a service
network (Remote Care) for diagnostic purposes and install software updates.
The device may only be connected to an available network, for example during the initial installation, by Leica-authorized service technician in cooperation with the local IT
department.
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5.8
Reagent list
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Open
pen the reagent list by pressing the adjacent button. This dis
displays all defined regents
ents in alphabetical order. Furthermore, a suitable reagent of a heated reagent
agents
cuvette
Fig. 36
37).
uvette (optional) (12
((12,
1 Fig
336)) can be assigne
assigned ((Fig.
Fig
g 37
37)
14
10
11
14
12
13
56
Fig. 36
Reagent name
Edit selected reagent
Abbreviation of the reagent name
Create a new reagent
Process class
10
Copy selected reagent
Maximum number of slides
11
Delete selected reagent
Maximum period of use
12
Edit settings of heated cuvettes for the selected reagent
Heated reagent cuvette yes/no
13
Activate/deactivate RMS
Insert for special dye yes/no
14
You can scroll through the reagent list using
the arrow keys.
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Reagent list (continued)
 When setting up the instrument, the reagent list only contains rreagents from the preinstalled Leica programs.
 Additional reagents can be added or properties of the reage
reagents can be changed as
needed in the reagent list.
 Creating or editing a reagent requires "Supervisor" mode. The "User" status only allows reagent data to be displayed.
 The "RMS: On – Off" (13, Fig. 36) allows the reagent management system = RMS to be
switched on or off. This system controls the reagent consumption monitoring. We always recommend keeping the RMS switched on and following the instructions for replacing a reagent (see Chap. 6.3). It is not possible to switch off reagent monitoring
for the Leica staining kit reagents.
 Failure to adhere to the specified intervals can have a negative effect on the staining
quality. The RMS only works reliably if the data has been stored by the user correctly
in advance.
 The manufacturer assumes no liability for the staining results in case of errors when
entering the reagent data. The user cannot edit Leica-validated reagents.
5.8.1 Define heated reagent (optional)
Fig. 37
 Select the desired reagent in the reagent list by touching it.
 Press the "Heated reagent station" (12, Fig. 36) button
to open the settings menu (Fig. 37).
 Set the slider (1, Fig. 37) to "Yes" to activate the heated
reagent station.
 Select the operation mode (2, Fig. 37).
 Configure the temperature using the roller (3, Fig. 37).
 Save the entries with the "Save" button or close the
menu with the "Cancel" button to close the menu without
applying the entries.
Reagents like xylene, xylene substitute, alcohols and solutions containing alcohol may
not be defined as a heated reagent!
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5.8.2 Creating a new reagent
Creatingg or editing a reagent requires "Supervisor" mode. The "User"
"User status only allows
ent data to be displayed.
reagent
Fig. 38
 To add a new reagent to the reagent list, press the "New" (see 9, Fig. 36) button.
 It opens the entry window for the new reagent to be created (see Fig. 38).
 The following parameters can be entered:
Reagent name
Push the "Reagent name" (1, Fig. 38) button and enter a unique reagent name that has not yet
been used using the onscreen keyboard. You can enter up to 24 characters (including spaces).
Abbreviation
The "Abbreviation" (2, Fig. 38) button can be pressed to enter a unique reagent name that has
not yet been used using the onscreen keyboard (maximum 10 characters, including spaces).
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5.8.2 Creating a new reagent (continued)
Max. specimen
men slides:
8) is used to configure the maximum number of slides that can be processed
The roller (3,
38)
3,, Fig. 38
iis requested.
t d B
t ti th
with this reagentt bbefore
a reagentt change
By rotating
the rollers, values between
1 through 3999 are permitted.
Max. days:
The maximum number of days (4, Fig. 38) that the reagent can remain in the instrument is configured by rotating the roller. Values from 1 through 99 are permitted when entering figures.
Holder for 5 specimen slides:
If a reagent cuvette is equipped with an element for special staining to enable a smaller reagent volume, using the slide rack for 5 slides only is possible in this cuvette. Then, you must
set the slide switch to "Yes".
Using a slide rack for 30 slides in this cuvette is now disabled.
Using the element for special staining in one or more reagent cuvette(s) requires
switching to the "Yes" position. If the switch is not set correctly for the affected reagent
cuvette(s), it can cause a slide rack for 30 slides to be used in this cuvette, which inevitably leads to a serious equipment failure with possible specimen loss.
Process class:
Assigning the reagents to process classes (6, Fig. 38) is required since, along with the prioritization of programs, it is essential for calculating the individual positions of the bathlayout (see
Chap. 5.8.2).
 Save the entries with the "Save" (7, Fig. 38) button or close the entry window without applying
the entry using the "Cancel" (8, Fig. 38) button.
Subsequently changing a process class is no longer possible after the initial save. The
reagent can only be deleted and re-created or copied and then changed.
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5.8.3 Process classes
Processs classes must be assigned correctly since it can otherwise
otherw
cause delayed
kflows in the staining processes and deviating or inadequate staining
sta
workflows
results.
The reagent process classes of preinstalled Leica programs are already defined and
cannot be changed.
Fig. 39
60
The preferred zone for dewaxing reagents is the left side of the bathlayout.
The preferred zone for staining solutions or differentiating solutions are the two rows to
the left and right of the rinsing water stations.
The preferred zone for draining reagents is the right side of the bathlayout.
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5.8.3 Process classes (continued)
No two successive rinsing water steps can be programmed (rins
(rinsing water step for aqua
est. or vice versa). If the sequence of the program steps is to ooccur in this way, one of
dest.
he steps has to be defined as a reagent assigned to a process cl
the
class (e.g. neutralizing).
Process class
Description
Dewaxing
(Dewaxing)
 Solvents that remove the paraffin and,  Xylene
following the paraffin removal, the  Xylene substitute
subsequent graded alcohol series, at the  Graded alcohol sebeginning of a staining program.
ries: 100 %, 95 %, 70 %
alcohol
Neutralizing
(Neutralizing)
 Reagents that have little or no effect on the  Aqua dest. (deminstain application or the stain development
eralized)/fresh water
(not in rinsing water
and that have a roughly neutral pH value.
 Example: Aqua dest. step before a stainstations!)
 Thinning with aqua
ing step.
dest.
 Aqueous alcoholic
solutions (e.g. 70 %
ethanol)
Staining
(Staining)
 All staining solutions
 Staining solutions
 Wood stains and oxi Wood stains
 Oxidizing agents (e.g. Periodic acid of the
dizing agents
PAS dye)
Differentiating
(Differentiating)
 Reagents that remove excess color from Low pH value:
 HCL solution (alcoholic
the product.
or aqueous)
 Reagents that are required for the stain
development or a color change.
 Acetic acid
High pH value:
 Ammonia water
 Scott's tap water
 Blueing Solution
 Blue Buffer
 Lithium Carbonate
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5.8.3 Process classes (continued)
Process class
Description
Example
Examp of reagents
Dehydrating
(Dehydrating)
 Reagents of the ascending alcohol series,
at the end of a staining program.
 Subsequent solvent steps (xylene or xylene substitute), at the end of a staining
program, for preparing the coverslipping
operation.
Dehyd
Dehydration:
 Ascending alcohol series: 70 %, 95 %, 100 %
alcohol
Preparing the coverslipping operation:
 Xylene
 Xylene substitute
The following must be observed for preparing the coverslipping operation:
 The solvent used at the end of the program and in the following coverslipping process
must be compatible with the mountant.
No class
(no class)
Reagents that do not require any special assignment in the bathlayout
(see information below).
The correct assignment of the process classes is necessary so that the optimal bathlayout can be calculated and long transport paths and times can be avoided.
Basic rules of automatic creation of the bathlayout include:
 The transfer from the left cuvette field to the right cuvette field should occur via a
rinsing water station whenever possible.
 Programs that do not contain a rinsing water station as a step use the dry transfer station for this transfer.
 Staining reagents that require a subsequent rinsing water step are positioned adjacent to the water flow cuvettes (Zone 2, Fig. 39).
 Reagents for which "No class" has been assigned as a process class are set at any
position during the automatic creation of the bathlayout.
 Instead of the "No class" assignment, we recommend assigning these reagents to either the "Differentiating" or "Neutralizing" project class so that adjacent stations in
the bathlayout can be taken into account for series.
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Staining program
The list of the staining programs installed on the SPECTRA ST is opened by pushing the "Programs"
rogram button.
A distinction is made between two types of staining progra
programs:
 Leica staining programs (preinstalled) (see Chap. 5.9.2)
 User-defined staining programs (see Chap. 5.9.4)
10
11
Fig. 39
The program is taken into account 7
in the current bathlayout.
Create a new program
Assigned program color
Copy selected program
Program abbreviation
Delete selected program
Program name
10
Assign a color to the selected program
Preinstalled Leica program
11
Define bathlayout
Edit program
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5.9.1 Staining program - general settings
 A slide rack handle color can be assigned to each program.
ting the staining intensity and rack handle color assignment re
 Editing
requires the "Supervior" user status.
status
sor"
 In the program list (Fig. 40), select the program that is to be
assigned a slide rack handle color by touching the corresponding entry.
 Pressing the "Color" (10, Fig. 40) button is used to display a
selection field (Fig. 41) that allows assigning the slide rack
handle color to the selected program.
Fig. 41
 All available colors are displayed in Fig. 41. If an abbreviation is entered in the color field, this color has
already been assigned to a program.
 If an already assigned color is selected, a dialog box
appears with a security prompt indicating that the
existing assignment will be undone. This can be confirmed with "OK" or aborted with "Cancel".
 Select a color that has not been assigned previously.
 "Save" is used to assign the color and close the dialog.
 "Cancel" is used to close the dialog without applying the changes.
The color white is a wildcard color. When selecting a white clip for the slide rack, a
program selection window opens in which a color has to be assigned to the white clip.
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5.9.2 Leica staining programs (preinstalled)
 Leica staining
aining
ning programs are preinstalled at the factory and have had ttheir function and stainerties tested. They ensure a uniform staining quality for a specified
spe
ing properties
number of slides.
 Leica staining
with
i i programs are labeled
l b l d in
i the
h last
l column
i h a cursive
i Leica "L" (5, Fig. 40).
Fig. 42
 Leica staining programs require the use of the specific Leica reagent kit.
 The individual program steps of the Leica staining program cannot be shown, edited,
copied or deleted.
 If the Leica staining program provides for it, the oven step can be enabled or disabled.
 Likewise, the last program step for unloading the racks into the output drawer or for
transferring them to the SPECTRA CV robotic coverslipper can be programmed.
If a paraffin removal step is not provided as the first step for the Leica staining program,
then the oven step (see 1, Fig. 42) must not be enabled, as otherwise the specimens
could be destroyed!
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5.9.3 Adapting the Leica H&E staining program
With thee Leica H&E staining program, the staining intensity can be adjusted for hemalin and eosin. Other Leica staining programs do not allow for any
an adjustments to the
toxylin
ning intensiti
staining
intensities.
After the user adjusts the staining intensity, the staining result has to be checked with
a specimen cycle (trial sections) before the settings are used for patient specimens for
clinical diagnostics.
Fig. 43
If "Edit" (6, Fig. 40) is selected in the program list,
a dialog opens that enables the staining intensity
to be set.
 The staining intensity values can be set by
turning the rollers. Smaller numerical values
cause a lower staining intensity; higher numerical values cause a larger staining intensity.
 A rack handle color can be assigned to the
program (see Chap. 5.9.1).
 Use "Save" to save the settings and close the
dialog.
 Use "Cancel" to close the dialog without saving changes.
5.9.4 User-defined staining programs
Creating a new staining program or editing an existing staining program requires the
"Supervisor" user status.
The "User" status only allows program steps to be displayed.
 Leica can provide neither testing nor a warranty for user-defined programs.
 Testing of these staining programs, with the respectively used reagents, must be carried out in the lab by the user. To do so, the staining result has to be checked with a
specimen cycle (trial sections) before the program is used for patient specimens for
clinical diagnostics.
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5.9.5 Creating a new staining program
 In thee list view of the programs, press
butto
o (1, Fig. 44).
the "New" button

 A new
w program w
window opens.
Fig. 44
Two empty buttons are shown in the upper
area of this window. They are intended for
the program name and its abbreviation.
 Press the "--" button behind the "Program Name" designation.
 An input mask with keyboard appears.
 Enter the program name.
 Press the "OK" button to finish.
Proceed as described above to enter the
"Abbreviation".
Fig. 45
To create a new staining program, multiple program steps are added to the program in
sequence.
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5.9.5 Creating a new staining program (continued)
Fig. 46
 After a new program has been created, press the "New" button (see 1, Fig. 45).
 A window opens for defining the program step (Fig. 46).
 The reagents already predefined by the user are listed in the area on the left (1, Fig. 46). This
is marked by selecting a reagent.
 The reaction time (hh/mm/ss) of the specimens in the reagent is defined in the area on the
right by turning the rollers (2, Fig. 46).
 The valid setting range goes from 1 second up to 23 hours 59 minutes and 59 seconds.
 The permitted "Tolerance" (3, Fig. 46) of the step is set under this. If an accurate program step
is needed that does not allow chronological expansion of the specified time, the tolerance
0 % must be selected. The tolerance can be selected in 25 % increments up to a maximum
expansion of 100 %, i.e. the instrument can extend the step to twice the length of the configured time, if needed.
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5.9.6 Inserting a new program step (continued)
A large
rge time tolerance setting is recommended if no negative effects
eff
on the staining reult are to be expected. This gives the instrument more room tto synchronize steps of
sult
multiple programs running at the same time
time.
 If a check mark is in the "BL" column (4, Fig. 46), it means that this reagent is already integrated into the bathlayout.
 To limit the display to reagents that are already actively used in the bathlayout, enable the
radio button "Show only reagents of current bathlayout" (5, Fig. 46).
 If the "Exclusive" box (6, Fig. 46) is enabled, the selected reagent can be used only for the
created program and no other program is available for selection.
 The program step entry is completed with "OK" (7, Fig. 46).
 Depending on need, other program steps can be added in the same way until all staining
process steps are illustrated in the program.
A program must always be concluded with a final target station step. Either the output
drawer (Unloader UNL) or the transfer station (Transfer Station TRA – only in workstation mode) can be selected for transfer to the SPECTRA CV robotic coverslipper
A warning message indicates that saving the program
without defining the target station as the last step is not
possible.
Fig. 47
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5.9.7 Resorting a program step
 The program step is highlighted in red
pon selection. Now the "Move" buttons
upon
(1-4,
(1 4 Fig.
Fig 48)
48) are active.
ac
Press to move the selected program
step to the first row.
Press to move the selected program
step one row up.
Press to move the selected program
step one row down.
Press to move the selected program
step to the last row.
Fig. 48
 The "Save" button saves the current
status.
If an oven step is used as a first program step, a flammable solvent must not be present
in the load station of the input drawer under any circumstances.
This can cause a detonation in the oven, which can cause the operator to be burned,
specimen loss and damages to the instrument and equipment.
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5.9.8 Prioritizing programs
 After all des
desired staining programs
have been entered,
the bathlayout
has
generated. To do so, proas to be ge
ceed as follows:
 In the first step, the supervisor
should define which programs are
to be taken into the bathlayout. The
programs are activated via the radio
button (see 1, Fig. 49).
 The position of the program determines its priority for the integration
into the bathlayout
Fig. 49
Priority:
 Leica staining programs are always placed at the beginning of the program list. The
positions of the Leica staining programs cannot be changed.
 The positions of the user-defined programs can be moved.
 The user-defined programs with low position numbers are easier to take into account
when creating the bathlayout than programs with high position numbers.
 We recommend positioning user-defined programs with high specimen throughput at
the beginning of the program list, following the Leica staining programs.
If a higher priority is to be assigned to a staining program, it must be moved higher in the list
using the "Move" button:
 The program is moved to the first row (2, Fig. 49)
 The program is moved one row up (3, Fig. 49)
 The program is moved one row down (4, Fig. 49)
 The program is moved to the last row (5, Fig. 49)
 Due to the new prioritization, the bathlayout has to be newly created (see Chap. 5.9.9).
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5.9.9 Creating a bathlayout
The arrangement
angement of the reagent stations in the instrument is calcula
calculated using the prioriee Chap. 5.9.8)
tizedd staining programs (see
5.9.8).
se are some things to be observed when doing so:
These
 Leica staining programs are taken into account first,
 Staining and differentiation solutions are placed as close as possible to the water
flow cuvettes,
 The program prioritization and process class assignment are observed,
 Sequential process steps must be located close to each other.
 To start calculating the bathlayout, press the
"Define bathlayout" button (6, Fig. 49).
 Press the "Create bathlayout" button to proceed
or the "Cancel" button to return to the program
selection.
Fig. 50
Be sure to observe the warning message displayed after pressing the "Define
bathlayout" button (Fig. 50)!
Integration of Leica staining programs
If the software detects that a Leica staining program is integrated into the bathlayout, an
information message (Fig. 51) opens, prompting the user to scan the Leica reagent kit in
the next step.
Procedure for scanning the Leica reagent kit
 When prompted by an information message (Fig. 52) on the screen, stop the carton's packaging label in front of the RFID sensor on the front of the instrument (1, Fig. 53) to scan it.
 Likewise, scan the labels of the individual reagent bottles when prompted.
 The user has 3 minutes to scan the reagents for the carton's packaging label and
1 minute per reagent bottle.
 If the time is not used, the user is prompted to restart or resume the scanning process.
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5.9.9 Creating a bathlayout (continued)
Fig. 52
Fig. 51
Fig. 53
The reagent management system (RMS) automatically takes over the following data for
the Leica reagents: The use-by date (onboard shelf life), remaining number of slides,
max. number of slides, expiration date and the batch number.
 After scanning each individual reagent bottle, the instrument prompts
the user to fill this into a reagent
cuvette and to place it into the instrument at the specified position
(1, Fig. 54).
Reagent cuvettes must always be filled outside of the
instrument in compliance
with the safety information.
Fig. 54
 Confirm the correct insertion by
touching the specified position on
the screen.
 Repeat these steps for all reagents
of the Leica reagent kit.
The arrangement of the bathlayout is to be followed exactly. Any deviation can lead to
undesired staining results.
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5.9.9 Creating a bathlayout (continued)
After scanning
canning and inserting the Leica reagents, the further reagents
reagent of the Leica staining program (e.g. xylenes, alcohols) and those of the user-defined programs are prosed in the next step.
step
cessed
Integration of user-defined programs
 To create the bathlayout, press the "Create bathlayout" button (6, Fig. 49).
Be sure to observe the warning message displayed after pressing the "Create
bathlayout" button (Fig. 55)!
Fig. 55
Fig. 56
 Press the "Continue" button to proceed
or the "Cancel" button to return to the
program selection.
 An overview of the bathlayout (Fig. 56)
is displayed.
 The reagent stations to be filled are
outlined in orange (Fig. 56).
 One by one, take the reagent cuvettes
out of the instrument, fill them with the
respective reagent outside of the instrument and return them to the correct
position.
 Touch the corresponding station on the
screen to confirm the respective reagent
change or refilling.
 Repeat these steps for all displayed,
marked stations.
The arrangement of the assignment plan is to be followed exactly. Any deviation can
lead to undesired staining results.
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5.9.10 Adjusting a bathlayout
The automatically
atically and optimally created bathlayout should be adjusted only if special user reents were not taken into account
quirements
account.
Each adjustment of the bathlayout can have a negative effect on the specimen throughput and
staining result!
The following rules must be observed when adjusting the bathlayout:
 Reagent stations must not be moved from one side of the cuvette field to the other because
this causes unnecessarily long transfer times.
 Duplicate stations should be inserted adjacent to the original station in the bathlayout.
Fig. 57
If you need to adjust the bed layout
created by SPECTRA ST, which takes
into account all optimized regulations, this can be done by means of
the function "Adapt Bathlayout".
Using this function, station placements can be moved to their positions within the bathlayout and/or
duplicated.
To do so, proceed as follows:
 In the station assignment view,
press the "Adapt Bathlayout" (1,
Fig. 57) button.
 Observe the messages that follow
(Fig. 58+Fig. 59) and confirm or
press "Cancel" (Fig. 59) to return to
the station assignment view.
Fig. 58
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5.9.9 Adapt Bathlayout (continued)
Fig. 59
Fig. 60
 After confirmation, the "Clipboard"
(Fig. 60)
will open, to which up to 6 reagent stations
(1 Fig.
Fig
ig 60)
60 can be moved.
moved
(1,
There are two options for changing the bathlayout:
Move the reagent stations to connect them:
 To move reagent stations, select them individually in the bathlayout by touching the
screen and then tapping an available position
in the clipboard.
 This moves the reagent station to the clipboard.
 Finally, select the reagent station in the
clipboard by tapping and dragging it to the
desired (available) station (e.g. 2, Fig. 57) in
the bathlayout.
 To save your changes, press the "Finish"
button and confirm the subsequent message
with a "Yes" or "No" to return to the clipboard.
 To delete the changes, press "Cancel" and
answer the subsequent message with a "Yes".
Duplicate a reagent station
 To duplicate a reagent station, select it in the
bathlayout by touching the screen.
 Finally, press the "Duplicate" (5, Fig. 60) button.
 The clipboard can be closed only if no more reagent stations are in it.
 After changes have been made using the "Adapt Bathlayout" function, an automatic
fill level scan is performed!
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5.9.9 Adapt Bathlayout (continued)
Leica
ca reagent stations, marked by an "L" before the reagent name
nam (3, Fig. 57), cannot be
duplicated
 Then, the reagent station will appear in the clipboard with an equivalence symbol () (4,
Fig. 57).
 After this, select the duplicate reagent station in the clipboard by touching the screen and
place it in the desired (available) station, near the original station in the bathlayout.
 To save your changes, press the "Finish" button and confirm the subsequent message with
a "Yes" or "No" to return to the clipboard.
 To delete the changes, press "Cancel" and answer the subsequent message with a "Yes".
Duplicated reagent stations make sense for program steps with a long dwell time in a reagent.
Duplicated stations make two equivalent reagent stations available for a program step, which
ensures getting a high specimen throughput.
Duplicated reagent stations can be deleted using the "Delete" button (4, Fig. 60). To do
so, mark them in the bathlayout by touching them and pressing the "Delete" button.
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6.1
Preparing the instrument for daily setup
 Fig. 61 shows
ows an overview of the various stations in the cuvette field.
field
r, the cuvette field consists of 36 reagent stations and 6 rinsing w
 Altogether,
water stations.
 The max. capacity of each reagent cuvette is 380 ml.
 When using the optional module with four reagent cuvettes that can be individually heated,
32 reagent stations are available.
78
Fig. 61
6 oven stations
5 unloading stations,
4 heated reagent stations (optional)
Dry transfer station
Left reagent cuvette field
Rinsing water stations (group of two)
Rinsing water stations (group of four)
5 loading stations
Right reagent cuvette field
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6.2.
Daily Instrument Setup
Daily setup of the instrument
Before
ore setting up the instrument every day, check the water inle
inlet to the instrument and
turn
urn it if necessary.
 Open the instrument cover and remove the covers from the reagent cuvettes.
 Switch on the instrument.
Automatic fill level scan when initializing the instrument
During the initialization, fill level scans are automatically carried out in the following areas:
 Reagent cuvettes
 Water flow cuvettes
 Reagent cuvettes of the loading and unloading stations
 Oven station
 Heated reagent cuvettes (optional)
If there are still racks, reagent cuvettes that are insufficiently filled or still covered, and/
or water flow cuvettes that are not ready to use in the instrument, this is determined
during the automatic fill level scan and displayed when finished.
6.2.1 Preparation and handling of reagent cuvettes
To ensure that everything runs smoothly in the instrument, observe the following notes and
proceed as follows.
Attaching the reagent cuvette clip
Check whether the reagent cuvette clip is correctly attached to the reagent cuvette. If this is
not the case, fasten the clip according to Fig. 62.
Filling and draining reagent cuvettes
The reagent cuvettes are always to be filled or drained outside of the instrument to
avoid or reduce the risk of spilling reagents into other reagent cuvettes and onto interior instrument components. Proceed carefully and thoroughly when filling or draining
the reagent cuvettes and follow the respectively applicable laboratory specifications.
If reagents were spilled or another reagent station has been contaminated, it must be
cleaned and re-filled.
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6.2.1 Preparation and handling of reagent cuvettes (continued)
Correct fill level
el of the reagent cuvettes
eagent cuvettes, observe the fill level marks inside the rea
 To fill the reagent
reagent cuvettes (see
marks in Fig. 62 and Fig. 63).
 A sufficient filling level is ensured if the level of the reagents is between the maximum and
minimum fill level marks (see marks in Fig. 62).
 If the insert for special dyes (Fig. 63) is to be used in the reagent cuvettes (also heated), first
put it into the reagent cuvette and then fill the reagent at least up to the displayed minimum
filling level (see mark in Fig. 63).
Inserting the reagent cuvette into the bathlayout
 Select "Bathlayout" in the main menu (see Chap. 5.5) and insert the reagent cuvette into the
correct position according to the arrangement of the bathlayout.
Carefully insert the reagent cuvette with clip into the cuvette field so that the clip is on
the right side of the reagent cuvette when looking at the cuvette field.
This orientation of the clip is recommended also for placing the reagent cuvettes in the
loading or unloading station and in heated reagent cuvettes (see Optional Accessories).
Correct fill level of the reagent cuvettes
Maximum fill level
Correct fill level when using the insert for
special dyes
Minimal fill level
Minimal fill level
Fig. 62
80
Fig. 63
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Daily Instrument Setup
6.2.2 Automatic fill level scan
After filling and inserting the reagent cuvettes, the automatic fill level sc
scan (1, Fig. 64) should be
carried out for verifying that all reagents used have the correct fill leve
level.
 The load and unload stations are not taken into account when creating the bathlayout. Reagents in the load and unload stations have to be defined and monitored by the
user.
 The reagents in the loading and unloading stations are not monitored by the reagent
management system. Therefore the user is responsible for making sure the reagents
in these stations are in flawless condition.
To start the fill level scan, proceed as follows:
 Call up "Bathlayout" in the main menu (see
Chap. 5.5).
 The "Fill Level Scan" button (1, Fig. 64) is in the
lower part of the menu screen.
 Press this button to start the fill level scan.
Irregularities during the fill level scan
are displayed on the screen. Follow
the information messages and, for example, correct the fill level, remove
the cover, add reagent cuvettes, etc.
Fig. 64
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6.3
Reagent management system (RMS)
The bathlayout in the instrument is illustrated by pressing the ad
adjacent menu button.
Thiss display shows the current layout of the reagent stations, th
the rinsing water stationss and the loading and unloading stations in the instrument
instrument.
Fig. 65
The bathlayout is empty when the instrument is delivered, because reagents still have not been
defined and a bathlayout has not yet been created.
If reagents and programs were defined (see Chap. 5.8.1) and the bathlayout was created, the
overview shows all stations in the instrument in their real order.
Each reagent cuvette shown in the bathlayout contains additional information:
 Station number
 Reagent name
 A background color
 Equivalence symbol for a duplicated reagent station
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6.3
Daily Instrument Setup
Reagent management system (RMS) (continued)
The background color shows the consumption status of the reag
reagent (Fig. 66). When use
cha
progresses from bottom to top, the color column grows and changes
color, depending
on the consumption status:
Green:
Consumption status between 0-80 % of the maximum use limit
Yellow: Consumption status between 80-95 % of the maximum use limit
Red:
Consumption status between 95-100 % of the maximum use limit
As soon as the "Red" consumption status has been reached, but no later than when the
station flashes red, the reagent in question has to be replaced. If this is not done, Leica
staining programs are no longer able to start.
Fig. 66
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6.4
Station features
tion in the bathlayout will display more information (station details). The followTouching a station
ess are distinguished by their abbreviatio
abbreviation:
ing station types
L01-L05
Load stations
SID
Slide reading module and title block identification (optional)
O01-O06
Oven stations for drying the slides and starting to melt the paraffin
R01-R42
Reagent stations
W08-W09
W22-W23
Rinsing water stations (group of four)
W36-W37
Rinsing water stations (group of two)
H01-H02
H15-H16
Heated reagent stations (optional)
D01-D02
Dry transfer stations
U01-U05
Unloading stations in the output drawer
Slide reader module (SID):
When this station is touched, a note appears
saying that this station is the slide reader module. The "Close" button is used to close the display.
Fig. 67
Oven stations:
The detail view of an oven station shows:
 The current temperature,
 The target temperature adjustment and
 The operation mode of the 6 oven stations.
The "Close" button is used to close the display.
Fig. 68
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6.4
Daily Instrument Setup
Station features (continued)
Rinsing water stations (g
(group of four):
rinsing water station shows
The detail view of a rinsin
all other rinsing water stations that are connected to the same water circuit. The "Close" button
is used to close the display.
Fig. 69
Fig. 70
Rinsing water stations (group of two):
When you touch a group-of-two rinsing water station, an information window opens that
shows the 2 water stations, which are connected to the second water circuit with, for example,
distilled water or demineralized water (1, Fig. 70)
or rinsing water (2, Fig. 70) .
 Depending on the connected supply, the corresponding selection will have to be made in
this menu.
To install an additional running water
connection, see Chap. 4.2.
The correct assignment and connection of the water flow cuvettes is absolutely necessary for achieving good
staining quality.
 To take over the setting, press the "Save" (3,
Fig. 70) or "Cancel" button (4, Fig. 70) to close
the display.
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6.4
Station features (continued)
Fig. 71
The load and unload stations
are not taken into account
when creating the bathlayout.
Reagents in the load and unload stations have to be defined
and monitored by the user.
The slide racks are transported
into any free unload station at
the end of a program. Therefore, all unload stations must
be filled with the same reagent.
The samples can potentially
become damaged if this is not
observed.
86
Load and unload stations in the drawers:
No reagents have been assi
assigned yet to the load
d unload
and
stations in the ffactory condition of
the instrument.
To assign a reagent, run the following steps:
 Select the corresponding load or unload station in the bathlayout (see Fig. 20) by touching
it.
 In the newly opened "Station details" window,
press the black "Reagent name" button to
open the list of available reagents (see Fig. 36,
Chap. 5.8).
 Select the desired reagent by touching it and
then hit "Apply".
 To apply the settings, press the "Save" button
or press "Cancel" to close the display.
The assigned reagent name is displayed in the
bathlayout.
 If a reagent is no longer required in the load
or unload station, the assignment to the respective reagent can be removed using the
"Delete" and "Save" buttons in the "Station
details" window.
Reagent stations:
An information window opens when the reagent
station is touched. It displays additional relevant
data regarding the station type.
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6.4
Daily Instrument Setup
Station features (continued)
Leica reagent station
tion
io
Reagent station
Heated
eated reagent
re
station
Fig. 72
Fig. 73
Fig. 74
Reagent name/abbrevia- See Chap. 5.8.1
tion
Consumption status
See Chap. 6.3
Remaining slides/max. Displays the number of remaining processable slides. When inserting a
slides
slide rack into the instrument, the slides contained in it are counted by the
slide reading module and subtracted from the number of remaining slides.
Onboard shelf life
Displays the shelf life of the reagent filled into the reagent cuvette (see
Chap. 5.8.1).
Expiry date/batch number is applied automatically when scanning the packaging of the Leica
reagent kit.
Insert yes/no
"Yes" indicates that the insert for special dyes and the slide rack for 5
slides is used. This station cannot be used for programs with slide racks
for 30 slides (see Chap. 5.5).
Exclusive Yes/No
The setting "Yes" defines that the reagent is only assigned to one program. "No" allows use by multiple programs (see Chap. 5.9.6).
Target temperature
Indicates the user-defined temperature for a heated reagent station.
Operation mode
Indicates the user-defined setting for a heated reagent station (activated
continuously or only when starting the program).
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6.4
Station features (continued)
Reagent replacement
cement
 If the RMS indicates
ndicates that a reagent is almost or completely consumed, a rreagent change must
b confirmed
fi
d by
b pushing
hi the
tth "Update
"U d t Reagent"
occur. This changeover
mustt be
(1, Fig. 72) button.
 When replacing the Leica reagents, first press the "Update Reagent" button and follow the
instructions for scanning and filling on the screen.
 The "Close" (2, Fig. 72) button is used to close the display.
 Updating the reagent status without replacing the corresponding reagent will inevitably affect the staining quality negatively.
 NEVER press the "Update Reagent" button if the reagent has not been replaced.
Each Leica reagent kit can only be scanned once!
Already added Leica reagents expire before their use-by date if a bathlayout is newly
created.
If the newly created bathlayout is subject to a final verification by the user or is to be
adapted and the Leica reagents have not yet been scanned and added, the following
procedure is recommended:
 After creating the bathlayout, cancel the prompt to scan the Leica reagent kits.
 Do not carry out any fill level scan.
Make up the Leica reagent kit scan and a fill level scan later.
This is used to prevent the Leica reagent kit from expiring early.
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Daily Instrument Setup
Prepare slide rack
Each slide rac
rack clip contains 2 RFID
chips. Therefor
Therefore, the slide rack clips
l bbe attached
tt
may only
to the slide rack
after a potential microwave step for
specimen preparation.
Fig. 75
Fig. 76
Leica HistoCore SPECTRA ST
Two different types of slide racks with compatible clips are available for use in the SPECTRA
ST staining machine:
 Slide rack for 30 specimen slides routine stainings (Fig. 75).
 Slide rack with layered clips for 5 slides for
special dyes (Fig. 76).
The colored clips must be correctly attached
prior to using the slide rack in the device.
The rack clips must be attached corresponding
to the previously defined program color (see
Chap. 5.9.1).
The specimen slide clips are available in 9 colors
(8 program colors & white) (see Chap. 9.2).
Special function of the white clip:
The white clip cannot be permanently
assigned to a staining program.
Corresponding to a "wildcard function", the white clip has to be reassigned to a program color each time
the program is started.
For this purpose, a selection menu
opens on the screen automatically after inserting the slide rack.
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6.5
Prepare slide rack (continued)
Ø
Ø
Proceed as follows
ows to attach or replace the slide rack clip
clips:
Fig. 77
Detach the clip from the slid
slide rack:
 Slightly pull the clip apart so that the clip wire
can be pulled from the bore in the holder.
Attaching a clip to a slide rack:
 Slightly pull apart the clip so that the clip wire
can snap into the respective bore in the holder.
 Be sure that the clip is correctly positioned in
the upper position, centered above the slide
rack (Fig. 77).
For a stable placement for filling, fold
the clip to the side as far as it goes
(Fig. 78) so it can be used for additional protection from tipping.
Fig. 78
When inserting the slides, be absolutely certain that the slide label is
pointing upwards and toward the user.
The side of the slide with the specimen must point toward the front side
of the slide rack.
The front side of the slide rack is labeled with the Leica logo. With the
clip attached, "Front" can be read
when looking at the clip (Fig. 79).
If the slides are not inserted correctly,
the samples can become damaged in
the further process sequence.
Fig. 79
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Daily Instrument Setup
Rack and preparatory work (continued)
 When using printable labels or manual labels on the slide ra
rack clips and the slides,
they must be checked for solvent resistance in advance.
 When inserting the slide into the slide rack, you have to make sure that the slides are
inserted into the respective slide rack for the desired staining program. The colored
slide rack clips allow secure assignment for the respective staining program.
 Make sure that only one slide each is put into the insert and that the slides are not
jammed.
6.6
The staining process
The following requirements must be met to carry out the staining process:





All settings are optimized (parameters for oven, heated cuvettes, etc.).
The programs required for staining have been created (see Chap. 5.9.5).
The reagent stations are filled with the correct reagents (see Chap. 6.2.1).
A fill level scan has been carried out (see Chap. 6.2).
The slide racks intended for staining are filled and the correct clips are attached to the slide
racks (see Chap. 6.5).
6.6.1 Start the staining process
The slide rack can be inserted using the input drawer only. Directly inserting it into any
reagent or oven station by opening the instrument cover is not permitted. These slide
racks cannot be recognized by the instrument and can cause collisions!




Fold the slide rack clip into the upright position (see Fig. 78).
If the input drawer is illuminated in green, press it and open the drawer.
As shown in Fig. 80, insert the slide rack into an available input drawer position.
Insert the slide rack so that both the Leica logo on the front side of the slide rack and the
"Front" label on the top of the colored clip are pointing toward the user. The arrow on the top
of the colored clip must point into the instrument.
 Press the input drawer button again to close it again.
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6.7.1 Start the staining process (continued)
Exercisee caution
cautio when opening or
closing the draw
drawers! Crushing hazTh drawers
ard! The
are motorized and
open automatically when the button
is pressed. Do not block the extension range of the drawers.
 After closing the input drawer, the instrument detects the RFID chip in the colored
clip.
 The identified color of the clip and the assigned program abbreviation are displayed
in the bathlayout at the respective station
(Fig. 81).
 An incorrectly oriented slide rack
is detected and displayed by the
instrument and must be corrected
by the user.
 The system detects if a slide rack
has been inserted into the input
drawer with a slide rack handle
color, for which no program is
specified in the bathlayout and
the user is informed by a information message. The slide rack must
be removed from the instrument.
Corresponding to the bootable
programs (see Fig. 82), attach the
correct colored clip to the slide
rack and re-insert it into the input
drawer.
Fig. 80
Fig. 81
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6.7.1 Start the staining process (continued)
Fig. 82
For the inserted slide racks, the instrument calculates throughput-optimized start times
that can deviate from the order of the inserted slide rack.
 Before the first program step, the instrument counts the slides used in the slide rack in the
slide reading module (see 2, Fig. 4).
 The determined number of slides is recorded and processed in the RMS and the consumption
status of the respective reagents is updated.
 Afterwards, the rack is transported into an oven station or reagent station, depending on
the defined first program step.
 The slide racks are now integrated into the staining process.
6.7.2 Monitoring the staining process
Using the following menu, the user can call up or monitor details for ongoing programs:
 Bathlayout with station details (Fig. 81).
 Process status display with calculated remaining program times and step times (see
Chap. 5.3).
 The status bar (see Chap. 5.2) with date, time and symbols that refer to messages and
warnings that occurred.
The last 20 messages and warnings can be called up by touching the corresponding
symbol in the status bar (see 7+8, Fig. 17). This gives the user the opportunity to become informed about past and current situations after the instrument is absent and initiate the required actions, if necessary.
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6.7.3 Staining process completed
Fig. 83
 After a slide rack has run through tthe staining process,
it is transported into the output dr
drawer and placed in
an available
position (Fig.
ilable posit
(Fig
ig 83).
83))
83
 To remove the slide rack from the unload station, press
the button on the output drawer for opening and remove
the slide rack.
 Press the button again after removal to close the output
drawer.
The output drawer must be opened and the slide
racks removed at the latest when the warning
message is received indicating that the output
station is completely occupied (Fig. 84). Failure
to comply with the warning message results in
not being able to transport further slide racks
into the output stations. Deviating step times
and delays in the staining process can change
the staining results.
Fig. 84
 The user receives a message if the output drawer is
open for longer than 60 seconds (Fig. 85).
Fig. 85
The warning message requests the user to close
the output drawer to prevent potential delays.
When the output drawer is open, the instrument
cannot place completely processed slide racks
into the unload stations. Deviating step times
and delays in the staining process can change
the staining results.
 Press the button on the output drawer for closing.
94
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Daily Instrument Setup
6.7.4 Canceling the staining program
 Staining programs ca
can only be canceled via
the process status dis
display.
select the cor To cancel a staining program,
responding slide rack in the process status
display (see x, Fig. xx front) by touching it.
 A list of program steps appears (Fig. 86), the
current step is marked in red.
 The frame of the window displays the color
assigned to the program, the program name
and the stored abbreviation.
 Press the "Cancel program" button.
 In the following message, confirm the program
termination with the "Yes" button or return to
the process status display with "No".
The message notes (Fig. 87) are absolutely necessary to observe.
Fig. 86
Fig. 87
Leica HistoCore SPECTRA ST
 The bathlayout is displayed after pressing the
"Yes" button. The position of the slide rack
is highlighted in orange in the instrument (1,
Fig. 88).
 Open the instrument cover; remove the slide
rack from the highlighted station.
 Close the hood again immediately.
 Confirm the removal of the slide rack by pressing the marked station (1, Fig. 88).
95
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Daily Instrument Setupp
6.7.4 Canceling the staining program (continued)
When removing th
the slide rack, proceed quickly and make sure that the
hhoodd only
l remains
i open for a short
amount of time. After opening the
hood, for safety reasons, all movements are interrupted until the hood is
closed again. Deviating step times, delays and changed staining results can
be caused each time the hood opens in
the staining process.
Fig. 88
Remaining staining programs are continued after a program termination.
6.7.5 Operation as a workstation
Fig. 89
96
The SPECTRA ST can be operated as a
workstation together with the SPECTRA CV robotic coverslipper. This allows an uninterrupted workflow from
entering into the staining machine up
to removing the completely stained
and covered specimen slides. An optional transfer station for the SPECTRA
CV is available for the SPECTRA ST
(see Optional Accessories). The optional transfer station and connection
of a SPECTRA CV to the SPECTRA ST
may only be installed by a Leica-certified service technician.
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66.
Daily Instrument Setup
6.7.5 Operation as a workstation (continued)
The user must adhere to the following in workstation operation!
 The SPECTRA ST unload stations must be filled with the same reagent (xylene or Leica ST Ultra xylene substitute) as the SPECTRA CV load station(
station(s).
 Each reagent added must be compatible with the mountant used.
 Filling the load and unload station with the same reagent is absolutely necessary in
order to prevent sample losses due to drying out in the case of instrument faults.
Fig. 90
Leica HistoCore SPECTRA ST
The current process status of both instruments
can be shown on the screen of the SPECTRA ST.
 To switch between the SPECTRA ST and
SPECTRA CV displays, press the "SPECTRA
CV" button in the process status (5, Fig. 16).
 The view then changes to the SPECTRA CV
status display (Fig. 89).
 In addition to the SPECTRA CV process status, messages are also shown on the screen
that pertain to the workstation operation or
SPECTRA CV.
 To return, press the "SPECTRA ST" (1, Fig. 89)
button.
 The illustration of individual racks in the
workstation operation displays the process
sequences in both the SPECTRA ST and SPECTRA CV. This display is illustrated in two parts.
 The upper section (1, Fig. 90) shows the process sequence in the SPECTRA ST.
 The lower range (2, Fig. 90) shows the process
sequence in the SPECTRA CV.
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Cleaning and Maintenance
nance
7.1
Important notes about this instrument cleaning
General
eral instructions
efore each cleaning, shut down the instrument using the operating
operat
 Before
switch and then
witch it off using the power switch!
switch
 No liquid may come into contact with the electrical connections or spill into the interior of the instrument or the housing below the transport arms!
 When using cleaning agents, observe the manufacturer's safety instructions and the
laboratory regulations valid in the country of use.
 Dispose of spent reagents in accordance with the laboratory guidelines in force in
your country!
The following applies to all instrument surfaces:
 Wipe up spilled solvents (reagents) without delay! The lid surfaces only have moderate resistance in the event of prolonged contact with solvents!
 Do not use any of the following for cleaning the outside surfaces of the instrument:
alcohol, detergents containing alcohol (e.g. window cleaner), abrasive cleaning powders, solvents containing acetone or xylene.
7.1.1 Exterior surfaces, varnished surfaces, instrument cover
The surfaces can be cleaned with a mild, pH-neutral, commercially available cleaning agent.
After cleaning the surfaces, wipe them off with a cloth moistened with water.
Varnished instrument surfaces and plastic surfaces (e.g. an instrument cover) may not
be cleaned with solvents like acetone, xylene, toluene, xylene substitutes, alcohol, alcohol mixtures and abrasives! In case of long-term exposure, the surfaces and instrument hood are only conditionally resistant to solvents.
7.1.2 TFT touchscreen
Clean the screen using a lint-free cloth. A suitable screen cleaner can be used in compliance
with the manufacturer information.
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Cleaning
and Maintenance
7.1.3 Interior and drain pan
7.1.5 Reading module for specimen slides
To clean the interior
or and the drain pan, remove
remov the
reagent cuvettes andd water flow cuvettes. Use a
ommercially available cleaning
clea
mild, pH-neutral, commercially
agent to clean these areas. After cleaning the
drain pan, rinse it thoroughly with water.
Check the recess of the sspecimen slide reading
module for dirt and reag
reagent residue. When using specimen slides that already have damaged
edges, it is possible that (1, Fig. 91) small glass
shards and splinters have collected. Therefore,
all dirt in this area must be carefully removed to
prevent injury.
7.1.4 Transport arms
To clean the surfaces of the transport arms,
these are to be wiped off with cloth moistened
with water.
Ensure that no liquids spill underneath the housing of the transport
arms because there are sensitive
parts here.
Fig. 91
Leica HistoCore SPECTRA ST
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Cleaning and Maintenance
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7.1.6 Input and output drawers
 Remove reagent cuvettes
uvettes from both drawe
drawers
and store them outside
instrument.
tside
de of the instrument
 Check the inside of the drawers for reagen
reagent
residue and remove where appropriate.
 Finally, insert the reagent cuvettes into the
correct positions again.
 Observe the existing labeling (1, Fig. 92) for
stations in the drawers.
Fig. 92
7.1.7 Dry transfer station
After inserting the dry transfer station, the
reagents can drip down. This residue must be
removed regularly.
 To do so (1, Fig. 93), remove the insert of the
dry transfer station by pulling upwards, check
for contamination and clean if necessary.
 Then, re-insert the insert and make sure it
snaps in correctly.
7.1.8 Transfer station (optional)
 Check the transfer station regularly for reagent
residue and clean if necessary.
Fig. 93
Fig. 94
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7.
Cleaning
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7.1.9 Reagent cuvettes, rinsing water cuvettes and heated cuvettes (optional)
 Remove the cuvettes
uvettes individually from the
hat
at the clip is in the correct
clip. Ensure that
position (see Chap
Chap. 66.2.1)
2 1)
1) to prevent spilling
sp
the reagent.
 The sealing ring (1, Fig. 95) must remain attached to the water flow cuvette.
 Dispose of reagents in accordance with the
local laboratory specifications.
 All cuvettes can be cleaned in a dishwasher,
at a maximum temperature of 65 °C, using a
standard, commercially available detergent
for lab dishwashers. In doing so, the clip can
remain attached to the various cuvettes.
Fig. 95
Never clean the plastic reagent cuvettes at temperatures higher than 65 °C since it can cause
the reagent cuvettes to become deformed!
 The water flow cuvettes are to be regularly checked for calcification, visible, microbiological deposits of bacteria, fungi, algae and permeability. Lime residue can be removed using a
mild vinegar-based cleaning solution. Finally, rinse off the cuvettes with clear water until the
cleaning agent residue has been removed.
 After cleaning the water flow cuvettes and before inserting them into the instrument again,
the connecting piece to the water supply system must be checked for correct positioning on
the black O-ring (see 1, Fig. 95).
 If an O-ring is missing or not positioned correctly, the water flow cuvettes may not be put
back into position after cleaning, because otherwise there is a danger of the rinsing function
being defective during the staining process.
 After attaching the O-ring or correcting its position, the water flow cuvettes can be put back
into position.
If the cleaned and filled reagent cuvettes need to be put back into the instrument, they need to
be put in the correct position in accordance with the displayed arrangement of the bathlayout
(see Fig. 56 in Chap. 5.9.9). To do so, switch on and initialize the instrument.
Leica HistoCore SPECTRA ST
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7.1.10 Rack and clip
 The rack is to be checked regularly for staining residue and other poss
possible contamination.
 The stained clip must be removed from the rack for cleaning.
 To remove staining reside from the rack
rack, immerse it in a bath of lukewar
lukewarm water and a mild,
pH-neutral lab cleaner and let the cleaner take effect. When doing so, carefully observe
the additional manufacturer information regarding cleaning agents and the recommended
application area.
 Then, strong staining contamination can be removed using a brush.
 Now, take your time to thoroughly rinse off the racks with fresh water until no more staining
and cleaning agent residue remains.
 If residue from the mountant remains on the racks, these can be placed in a bath of solvent.
The rack and clip may not remain in the solvent for a long time frame (e.g. several hours
or overnight), because this can lead to deformities!
It is essential to ensure that the solvent being used is compatible with the mountant.
Xylene or toluene-based mountants can be removed using a xylene bath. Xylene substitute-based mountants are removed using a bath containing a corresponding xylene
substitute.
The maximum exposure time in a solvent bath is 1-2 hours. The solvent can be washed
off with alcohol. Completely rinse the rack racks with water, then dry. If an additional
drying oven is used, a temperature of 70 °C may not be exceeded.
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Cleaning
and Maintenance
7.1.11 Water drain
The draining
aining system within the instrumentt must be regularly cleaned
ecked for correct flow
and checked
flow. If this
measure is not completed, the water
draining system must become clogged,
which could lead to interruptions or
malfunctions in the staining process.
 To clean the water draining system, remove
the 4 rear water flow cuvettes and all surrounding reagent cuvettes.
 The remaining cuvettes must be covered.
 Remove the drainage sieve and clean if necessary Fig. 97.
 Place one to two cleaning tablets with active
oxygen (e.g. a denture cleanser) into the drainage and dissolve in water to remove various
residue (reagents, bacteria, fungi, algae).
 Then, clean the entire curved drainage inside
the instrument with a long, flexible brush
Fig. 96.
 Check the flow by flushing thoroughly with
water.
 Insert the drainage sieve again, and put the cuvettes back in their original, defined positions.
e!
du
eo
ro
Im
Fig. 96
Fig. 97
Leica HistoCore SPECTRA ST
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Cleaning and Maintenance
nance
7.1.12 Water drain hose
The water drain hose must be checked
hecked once a year by a service technician auth
authorized by Leica.
7.1.13 Water intake filter – changing the filter cartridge
The integrated water intake filter included with
the instrument protects instrument's internal
water circuit components from damage due to
sediments and mineral deposits.
The water intake filter should therefore be
checked regularly and, when discolorations are
visible due to deposits, washed out or replaced
if necessary.
 To do so, shut off the water inlet.
 Unscrew the upper filter housing by rotating
the filter housing.
 Pull out the filter insert and wash it out or insert
a new filter insert if necessary.
 Re-attach and screw the filter housing.
 Reopen the water inlet.
104
Filter housing
Filter cartridge
Order No.: 14 0512 49332
Fig. 98
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7.
Cleaning
and Maintenance
7.1.14 Replacing the active carbon filter
The active carbonn filters installed in the instru
instruin
e the amount of reagent vapors
ment helps reduce
in the exhaust air. The life cycle of the filte
filter can
fluctuate strongly depending on intensity of use
and the reagent configuration of the instrument.
Therefore, replace the active carbon filter regularly (every 2-3 months) and dispose of it properly in accordance with the laboratory regulations
applicable in the country of use.
 The filter unit consists of two individual filter
elements (Fig. 99), which are accessible to the
user on the front of the instrument.
 They can be accessed without tools and removed by pulling on the pull tabs.
 Insert the new filter elements in an inverted
direction and in the same way so that the pull
tabs can also be seen and reached after pushing in completely and the printed-on arrow
points upwards.
 Both active carbon filters must be pushed in
until you feel them make contact with the rear
panel of the instrument.
Fig. 99
If inserted incorrectly, the active carbon filters can extend into the range
of movement of the two transport arms,
impeding or interrupting the staining
process.
Leica HistoCore SPECTRA ST
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Cleaning and Maintenance
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7.1.15 Cleaning the ovens
Beware of hot surfaces: After using the oven in the staining process, first sswitch the instrument
efore cleaning and wait for it to cool off. Only hold the oven inserts at the described posioff before
tions.
Regularly clean the sheet metal inserts for catching paraffin residue in the oven for dirt.
 Fold the moving oven cover up and to the left,
(1, Fig. 100) then pull it towards the front of the
instrument.
 Grasp both connected oven chambers in the
center (2, Fig. 100+101) and pull them upwards.
Fig. 100
For safe transport, after pulling out the
two oven chambers that are still connected, stabilize them on the bottom
by grasping them with your flat hand.
 Disconnect the two oven chambers by pulling
them up in opposite directions.
 You can then pull out the insert for catching
paraffin residue from the respective oven
chamber (3, Fig. 101).
 Check the sheet metal inserts for paraffin residue and dirt. To melt the paraffin, the inserts
can be placed in an external laboratory oven.
 After heating, wipe off the paraffin residue
with a lint-free cloth.
 Check the ventilation flaps in the oven chambers for proper function. If they are visibly
dirty, carefully clean them with a lint-free
cloth.
 Push the sheet metal insert into the respective
oven chamber, facing the right way.
106
Fig. 101
 Put both oven chambers back together and
insert them into the instrument.
The interior of the oven must not be
cleaned using solvents, as there is a
risk that solvent residues will get into
the oven and evaporate in the oven
when the process begins.
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7.
Cleaning
and Maintenance
7.1.16 Oven air filter
The air filter of thee oven should be checked and
cleaned regularly.
 To do so, remove
ove the filter insert
inser (1,
(1 Fig.
Fig
g 102)
and shake it out.
 After checking and cleaning, re-insert into the
oven in the same way.
The installation is carried out in reverse order.
Fig. 102
Leica HistoCore SPECTRA ST
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7.
Cleaning and Maintenance
nance
7.2
Recommended maintenance and cleaning intervals
To ensure trouble-free
ble-free operation of the instrument over a long period of ttime, the following is
mended
mended:
strongly recommended:
 You must carry
below.
arry out the maintenance and cleaning tasks listed belo
below
 Have the instrument checked at least once a year by a qualified service technician authorized by Leica.
 At the end of the warranty period, enter into a service contract. For more information, contact
the relevant customer service organization.
Daily cleaning and maintenance
If sensitive instrument parts and areas get very dirty or if reagents are spilled,
they must be cleaned immediately, as otherwise a reliable workflow is not
guaranteed.
Task
Refer also to
 Checking and filling/refilling the reagent cuvettes.
Chap. 6.2.1
 Covering the reagent cuvettes and, if necessary, storing them with
covers in the refrigerator.
108
 Checking the rack and clips for paraffin or dye residue and broken glass.
Chap. 7.1.10
 Check the slide reader module for reagent residue and clean it if
necessary.
Chap. 7.1.5
 Check the housing in the area of the input and output drawers for solvent
residue and clean it if necessary.
Chap. 7.1.6
 Check the transfer station (optional workstation) (Fig.) for solvent residues and clean if necessary.
Chap. 7.1.8
 Clean the insert of the dry transfer station and clean if necessary.
Chap. 7.1.7
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7.
Cleaning
and Maintenance
Cleaning and maintenance as necessary
Task
Refer also to
 Clean the
used
he screen using a lint-free cloth. A screen cleaner can be us
according to manufacturer instructions.
Chap. 7.1.2
 Cleaning outer/painted surfaces
Chap. 7.1.1
 Instrument cover
Chap. 7.1.1
Weekly cleaning and maintenance
Task
Refer also to
 Checking/cleaning the water flow cuvettes for bacterial contamination
and checking the sealing rings to make sure that they are present
Chap. 7.1.9
 Cleaning the reagent cuvettes
Chap. 6.2.1
 Checking/cleaning the heated reagent cuvettes
Chap. 7.1.9
 Cleaning the racks and clips.
Chap. 7.1.10
 Check the water drain and sieve within the instrument for proper function and clean it if necessary.
Chap. 7.1.11
 Checking transport arms for dirt and clean if necessary.
Chap. 7.1.4
Monthly maintenance and cleaning
Task
Refer also to
 Checking the water intake filter and changing it if necessary.
Chap. 7.1.13
 Checking and cleaning the air filter of the drying oven.
Chap. 7.1.16
 Cleaning the drip tray.
 Checking the drying oven insert and catch tray for paraffin residue
and cleaning it.
Leica HistoCore SPECTRA ST
Chap. 7.1.3
Chap. 7.1.15
109
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Cleaning and Maintenance
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Quarterly cleaning and maintenance
Task
 Changing the
he active carbon filter.
Refer also to
Chap. 7.1.14
Cleaning and maintenance every six months
Task
Refer also to
 Replace the water intake filter.
Chap. 7.1.13
Annual maintenance and cleaning
Task
Refer also to
 Checking and maintenance of the instrument by a service technician
authorized by Leica.
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8..
8.1
Malfunctions
Malfu
Malfunc
and Troubleshooting
Fault remedies for instrument malfunctions
Error/problem
Cause
Cau
Troubleshooting
Troubleshoot
ater drain partially or comcom Checking
hecking and maintaining the water
Rising water levell in the drain Water
pan with alarm.
pletely blocked
drain hose. For this purpose, contact
the responsible Leica service.
Water drainage system inside the instrument and/or
the drainage sieve partially or
completely blocked.
Checking and maintaining the water
drain system in the instrument.
Observe the cleaning instructions in
Chap. 7.1.11.
Observe regular maintenance intervals.
If the blockage remains, the water
inflow to the water flow cuvettes is
stopped and the staining process is
interrupted. Therefore, the specimens have to be removed from the
instrument and brought to a safe
position or temporary storage (see
warning message in Chap. 8.2).
Decreased flushing during the Water inlet in water flow custaining cycles with possibly vettes attenuated/blocked.
inconsistent staining results. Possible causes:
 Water flow cuvettes fit incorrectly (note O-ring).
 Calcification of the water
flow cuvette.
Monitoring and maintaining the
water flow cuvettes.
Observe the cleaning instructions
in Chap. 7.1.9.
Observe regular maintenance intervals.
Water flow cuvettes do not
drain automatically during
breaks in operation of the instrument. Standing water can
be a source for microbiological contamination in the water
flow cuvette and the samples.
Monitoring and maintaining the
water flow cuvettes.
Observe the cleaning instructions
in Chap. 7.1.9.
Observe regular maintenance intervals.
Leica HistoCore SPECTRA ST
The additional water drain hole
at the base of the water flow
cuvettes is blocked by calcification/dirt.
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8.
Malfunctions and Troubleshooting
ubleshooting
8.1
Fault remedies for instrument malfunctions (continued)
Error/problem
Cause
Troubleshooting
Insufficient flushing during the Water pressure too low in the
staining processes may yield intake drainage system of the
inconsistent staining results. lab or fluctuations at different
times of the day
The specified minimum
requirements for water pressure (see
Chap. 3.2) must be fulfilled (even
for possible deviations during the
daytime).
Plastic cuvettes are deformed. Use of reagents that are not
permitted (ex. phenol in ZiehlNeelson dye or Gram dye, etc.).
Incorrectly applied cleaning
procedure.
Monitoring the used reagents using
the list of permitted reagents (see
Appendix 1).
Observe the cleaning instructions
in Chap. 7.1.9.
Inconsistent staining results
The tolerance of the program Inspecting the staining protocols
step for staining reagents is not and reagents.
correctly defined.
Most short program steps demand
exact compliance with the staining
step. The tolerance of the reagent
must be set to 0 %.
Varying staining results
The process classes (paraffin Inspecting and correcting the asremoval, stainers, differentia- signed reagent classes based on
tion, etc.) for reagents were not Chap. 5.8.1
correctly assigned. This means
that the bathlayout might not
have been optimally created.
Reagents that are only to be Inspecting and correcting the proused by one program are used gramming of respective reagents.
by other programs. The reagent
is dirty because it was not programmed as "Exclusive".
112
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8..
8.1
Malfunctions
Malfu
Malfunc
and Troubleshooting
Fault remedies for instrument malfunctions (continued)
Error/problem
Cause
Cau
Troubleshooting
Troubleshoot
ue does not
After drying, tissue
adhere well enough to the
slide, and floats away during
the staining process.
Forr customer-defined program
protocols, the selected firing
time and oven temperature (or
both) are too low.
specting and
a correcting inforInspecting
mation about firing time and oven
temperature for customer-defined
protocols.
The staining processes are
complete, but repeated or
additional programming (supervisor mode) cannot be
completed.
Programming can only be com- Remove racks from the output drawpleted when the instrument is in er, then carry out programming.
sleep mode; in other words, no
racks may be in the process;
this also includes the positions
of the output drawer.
Initialization of the instrument Arms are blocked.
cannot be completed.
Leica HistoCore SPECTRA ST
Check that the active carbon filter
is in the correct position.
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8.
Malfunctions and Troubleshooting
ubleshooting
8.2
Power failure scenario
Im
tra age
ns , r
fe em
ra o
rm val
du of
rin ra
g p ck
ow fro
er m
fa the
ilu
re
 In case of a temporary power failure (under 5 seconds), the instrument
instrumen will continue to be
ithout
thout interruption via an internal output buffering.
operated without
 However, allll staining programs are canceled if there is a longer-term
failure for more
longer term power
po
than 5 seconds. A rack located in the transfer is attached to the closest possible secure
position between the reagent stations. This is done to prevent accidental lowering into a
reagent not compatible with the program.
 Afterwards, the rack must be removed from the transfer arm (Fig. 104).
Fig. 104
 This occurrence is saved in the results protocol (see Chap. 5.7.9).
 All racks within the process must be removed from the instrument by hand. Also be sure to
check the following positions on the rack and remove if necessary:
- Reader module for specimen slides (see 2, Fig. 4)
- Oven (see 10, Fig. 4)
- Transfer station for SPECTRA CV (see 6, Fig. 4)
 Make sure that the specimens are stored outside of the instrument in a suitable reagent
and that the steps of the current staining protocol are continued to the end of the protocol
manually. The user shall be responsible for further processing of the samples.
 After the power supply is restored, the instrument can be restarted and loaded with new
specimens.
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8.3
Malfu
Malfunc
Malfunctions and Troubleshooting
Replace main fuses
The instrument should be switched off using the
power switch and disconnected
discon
from the power
supply in the case of a instrument failure. The
main fuses can then be inspected.
 To do so, open the hood and unscrew the
two fuse holders on the top of the right cover
(1, Fig. 103) with a flat-head screwdriver and
check for damage.
Fig. 103
A suitable flat-head screwdriver must
be used to prevent damage to the fuse
holder.
Beware of defective fuses! Potential
risk of injury due to broken glass!
 If the fuse is defective, remove it from the fuse
holder and replace it with a new fuse.
 Installation occurs in the reverse sequence
of operations.
Only fuses with a T16 A H 250 V AC
fuse rating can be used.
Leica HistoCore SPECTRA ST
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9.
Instrument Components
ts and Specification
Specifications
9.1
Optional instrument components
The SPECTRA ST slide stainer can be equipped with the following optiona
optional modules. A subsent configuration with one or more of the options listed belo
quent equipment
below is possible. Note
that retrofitting also incurs a fee for a service call that can result in additional
additio costs along with
the option costs.
The component(s) must only be subsequently installed by Leica certified service technicians. This can result in additional costs.
Reader module for specimen slides
Fig. 105
Using the slide reader module, specimen slides
with printed barcodes can be read out and the
information can be sent to a LIS network system
connected to the instrument.
Note that specimen slide labels can be read using this module only if they contain the following
properties:
Barcode types:
 1D barcode: Code 128, up to 8 characters
 1D barcode: CODABAR, up to 8 characters
 2D barcode: Datamatrix, 17 mil. resolution, up
to 30 characters
 2D barcode: QR code, min. 21x21, max. 30x30
elements
The print quality of the specimen slide label must
at least conform to the quality level 2 (C) in accordance with ISO 15416 and EN797.
Order No.
116
14 0512 47193
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9.
9.1
Instrument Components
Com
Comp
and Specifications
Optional instrument components (continued)
Heated reagent cuvettes
Module
d l with
ith ffour iindividually
di i
heated reagent
cuvettes, 380 ml
Heated reagent cuvettes can individually heat up
to 4 reagents used for special dyes.
The module includes 4 heatable reagent cuvettes
that replace 4 unheated plastic reagent cuvettes.
The list of usable reagents (see Appendix 1) must
be observed.
Order No.
14 0512 47509
Fig. 106
Transfer module for racks
Leica SPECTRA CV: for use in the SPECTRA ST,
transferring samples to a connected robotic
coverslipper
When integrating a SPECTRA CV robotic coverslipper, this module is used as a workstation. It
transfers the specimen slide automatically from
the staining machine into the robotic coverslipper.
Order No.:
14 0512 47395
Fig. 107
Leica HistoCore SPECTRA ST
117
9.2
DRAFT
2014-08-21
Optional Accessories
Designation
Order No.
Outlet hose, length: 2 m
14 0475 35747
Supply hose for rinsing water
14 0474 32325
Water connection kit with filter
Supply hose 3, length: 1.5 m extension
Y piece
Double nipple G3/4 G3/8
Water filter housing
Filter cartridge
Bushing G3/4
14 0512 49324
14 0512 49334
14 3000 00351
14 3000 00350
14 0512 49331
14 0512 49332
14 3000 00360
Exhaust hose, length 2 m
14 0475 35762
Active carbon filter
14 0512 47131
Reagent cuvette, assembly, including reagent cuvette cover
14 0512 47086
Water flow cuvette assembly
14 0512 47087
Used for special dyes (only for racks designed for up to 5 specimen slides)
14 0512 49261
Rack for 30 specimen slides* (3 pcs. per package)
14 0512 52473
Rack 5 specimen slides* (3 pcs. per package)
14 0512 52475
Clip for rack 30 specimen slides* (yellow, 3 pcs. per package)
14 0512 52476
Clip for rack 30 specimen slides* (light blue, 3 pcs. per package)
14 0512 52477
Clip for rack 30 specimen slides* (dark blue, 3 pcs. per package)
14 0512 52478
Clip for rack 30 specimen slides* (pink, 3 pcs. per package)
14 0512 52479
Clip for rack 30 specimen slides* (red, 3 pcs. per package)
14 0512 52480
Clip for rack 30 specimen slides* (light green, 3 pcs. per package)
14 0512 52481
Clip for rack 30 specimen slides* (black, 3 pcs. per package)
14 0512 52482
Clip for rack 30 specimen slides* (gray, 3 pcs. per package)
14 0512 52483
Clip for rack 30 specimen slides* (white, 3 pcs. per package)
14 0512 52484
Clip for rack 5 specimen slides* (yellow, 3 pcs. per package)
14 0512 52494
Specimen slide*
118
Instructions for Use V 0.5 RevC - 08/2014
Designation
DRAFT
2014-08-21
Order No.
ecimen slides* (light blue, 3 pcs. per package)
packag
Clip for rack 5 specimen
14 0512 52495
Clip for rack 5 specimen slides* (dark blue, 3 pcs. per package)
14 0512 52496
Clip for rack 5 specimen slides* (pink, 3 pcs. per package)
14 0512 52497
Clip for rack 5 specimen slides* (red, 3 pcs. per package)
14 0512 52498
Clip for rack 5 specimen slides* (light green, 3 pcs. per package)
14 0512 52499
Clip for rack 5 specimen slides* (black, 3 pcs. per package)
14 0512 52500
Clip for rack 5 specimen slides* (gray, 3 pcs. per package)
14 0512 52501
Clip for rack 5 specimen slides* (white, 3 pcs. per package)
14 0512 52502
Specimen slide*
Leica HistoCore SPECTRA ST
119
9.
DRAFT
-08-21
Instrument Components
ts and Specification
Specifications
Outlet hose,
Length: 2 m
Order No.
No
14 0475 35747
Fig. 108
Supply hose for rinsing water,
Length: 2.50 m assembly with 3/4" connection for
water tap, incl. replacement seal
Order No.
14 0474 32325
Fig. 109
Water connection kit with filter
Order No.
14 0512 49324
Supply hose 3,
Length: 1.5 m extension
Y piece
2x G3/4 G3/8 double nipple
Walter filter housing
POROPLAST filter cartridge
Bushing G3/4
14 0512 49334
14 3000 00351
14 3000 00350
14 0512 49331
14 0512 49332
14 3000 00360
Fig. 1110
120
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
9.
Instrument Components
Com
Comp
and Specifications
Exhaust hose,
Length 2 m, assembly,
semb
fume hood
including
ncluding adapter for fum
Order
No.
d N
14 0475 35762
Fig. 111
Active carbon filter
Order No.
14 0512 47131
Fig. 112
Reagent cuvette
assembly, incl. reagent cuvette cover
Order No.
14 0512 47086
Fig. 113
Leica HistoCore SPECTRA ST
121
9.
DRAFT
2014-08-21
Instrument Components
ts and Specification
Specifications
Water flow cuvette assembly,
Order No.
14 0512 47087
Fig. 114
Used for special dyes
(only for racks designed for up to 5 specimen
slides),
Ø 10 mm, length: 2.5 m
Order No.
14 0512 49261
Fig. 115
Rack
30 specimen slides* (3 pcs. per package)
Order No.
14 0512 52473
Fig. 116
122
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
9.
Instrument Components
Comp
Com
and Specifications
Rack
slides* (3 pcs
pcs. per package)
5 specimen slides
Order No
No.
14 0512 52475
Set of slide racks for 5 slides, pack of 3
Fig. 117
Fig. 118
Fig. 119
Leica HistoCore SPECTRA ST
Clip for rack,
30 specimen slides*, (3 pcs. per package)
yellow
14 0512 52476
light blue
14 0512 52477
dark blue
14 0512 52478
pink
14 0512 52479
red
14 0512 52480
light green
14 0512 52481
black
14 0512 52482
gray
14 0512 52483
white
14 0512 52484
Clip for rack,
5 specimen slides*, (3 pcs. per package)
yellow
14 0512 52494
light blue
14 0512 52495
dark blue
14 0512 52496
pink
14 0512 52497
red
14 0512 52498
light green
14 0512 52499
black
14 0512 52500
gray
14 0512 52501
white
14 0512 52502
123
10.
DRAFT
2014-08-21
Garantie und Service
Warranty
Leica Biosystems Nussloch
ssloch GmbH guarantees that the contractual product deliv
delivered has been subjected to a comprehensive
in-house testing standards,
nsive quality control procedure based on the Leica in-hous
and that the product is faultless and complies with all technical specifications and/or
agreed chara
acteristics warranted.
The scope of the warranty is based on the content of the concluded agreement. The warranty terms
of your Leica sales organization or the organization from which you have purchased the contractual
product shall apply exclusively.
Service information
If you are in need of technical customer support or spare parts, please contact your Leica representative or the Leica dealer where you purchased the instrument.
Please provide the following information:
 Model name and serial number of the instrument.
 Location of the instrument and name of a contact person.
 Reason for the service call.
 The delivery date of the instrument.
124
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
11.
Deco
Decommissioning
and Disposal
The
he instrument or parts of the instrument must be disposed of ac
according to existing applicable, local regulations. All objects contaminated with spille
spilled reagents must be disfected immediately with a suitable disinfectant to prevent spre
infected
spreading to other areas of
the
he lab or to lab personnel.
Please comply with the Cleaning chapter for notes on cleaning the SPECTRA ST staining machine.
The instrument can be contaminated when using biohazardous specimens. Thorough disinfecting is required before re-commissioning or disposal (e.g. multiple cleaning steps, disinfection or sterilization). Dispose of the instrument in compliance with the applicable laboratory
specifications.
Contact your Leica representative for more information.
Instrument components such as the computer, monitor, etc. that are labeled with the crossed-out dust bin are affected by the European Directive
2002/96/EC for Waste Electrical and Electronic Equipment (WEEE) of the
European Parliament and the Council of January 27, 2003.
These objects must be disposed of via the collection points in accordance
with the local regulations. More information on disposal of the instrument
can be obtained from your local disposal company or your local Leica support staff.
Leica HistoCore SPECTRA ST
125
DRAFT
AFT
2014-08-21
12.
Decontamination Certificate
ificate (master)
Dear Customer,
o be returned to Leica Biosystems or serviced on site, must be cle
Any product which is to
cleaned and decontaminated
ner.
er. Since it is not possible to decontaminate against diseases ccaused by prions such
in the appropriate manner.
as CJD, BSE or CWD, instruments that have come into contact with prion-contaminat
prion-contaminated specimens cannot
be returned to Leica Biosystems for repairs. Prion-contaminated instruments will only be repaired after the
service technician has been made aware of the potential risks, informed about the applicable directives and
procedures for the respective institution, and provided with personal protective equipment. Please complete
this certificate carefully and place a copy with the instrument, attach it to the outside of the transport case or
hand it directly to the service engineer. If packages are returned, they will not be opened or have maintenance
measures begun until the Company or service technician has received confirmation of decontamination. Should
returned goods be considered a hazard by the Company, they will be returned immediately to the customer at
his/her expense.
Designation
Name/Model
Fabr. No.
KAT No.
Quantity
Check box A if applicable. Otherwise please complete all parts of B, providing further information as requested or appropriate.
A Yes
B 1
This equipment has not been in contact with unfixed biological samples.
Innere o. äußere Bereiche des Gerätes waren folg. gefährl. Substanzen ausgesetzt:
Additional information
Yes No
Blood, bodily fluids, pathological samples
Other biohazards
Chem. Stoffe/gesundheitsgefähr. Substanzen
Other hazards
Yes No
This equipment has been cleaned and decontaminated:
If yes, give details of the method:
Additional information
If no*, please indicate why not:
* Such equipment must not be returned without the written agreement of Leica Biosystems.
126
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
12.
Yes No
Decontamination
Deconta
Decontami
Certificate (master)
The
he equipment has been prepared to ensure safe handling/tr
handling/transportation.
Whenever
henever possible, please use the original packaging.
packaging
Important - to avoid refusal of shipment:
Place one copy in the unit prior to packaging or hand it over to the service engineer. Customer assumes all responsibility for the immediate return shipment of articles sent to Leica without proper
decontamination documentation.
If you have any further questions, please call your local Leica branch office.
Leica Internal Use: If applicable, note corresponding Job and RAN/RGA numbers:
Job Sheet No.:
____________________
SU Return Goods Authorization:
____________________
BU Return Authorization Number: ____________________
Signature/Date
Institute
Department
Name
Address
Position
E-mail
Phone
Fax
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17-19
69226 Nussloch, Germany
Phone: +49 (0) 6224 143 0
Fax:
+49 (0) 6224 143 268
Web: www.LeicaBiosystems.com
Leica HistoCore SPECTRA ST
127
Appendix 1
A1
DRAFT
2014 08 21
Compatible reagents
 Usingg non-listed reagents (e.g. acetone or solutions containing phenol) or reagents
nd acids in higher concentration than described can cause sp
and
specimens to be destroyed,
ro ed operators to be injured
inj red or the instrument
instr ment to be damaged.
damaged Use the instrument
in this way at your own risk. Leica Biosystems or affiliated sales and service organizations shall not assume any warranty claims or liability.
 Flammable reagents and solvents must not be heated for fire and explosion protection reasons. Keep away all ignition sources when handling flammable solvents and
reagents.
All Leica reagents for preinstalled Leica programs are tested with the instrument for
staining quality and compatibility of materials.
Staining method or reagent group
Reagent name
H&E kit
ST Hemalast
Leica Infinity
Notes
ST Hematoxylin
ST Differentiator
ST Bluing
ST Eosin
Leica SelecTech
560 Hematoxylin
560MX Hematoxylin
Define MX-aq
Blue Buffer-8
Y515 Alcoholic Eosin
Y515LT Alcoholic Eosin
515 Eosin Trichrome
Eosin Phloxine
128
Instructions for Use V 0.5 RevC - 08/2014
A1
DRAFT
2014-08-21
014
4 08 21
4-08-2
21
Appendix 1
Compatible reagents (continued)
Staining method or reagent group
Reagent name
O t h e r H & E r e - Leica
agents
Gill II Hematoxylin
Notes
Note
Gill III Hematoxylin
Harris Hematoxylin
Mayer's Hemalaun
Leica
Alcoholic Eosin
Aqueous Eosin (1 %)
Leica
Scott's Tap Water Solution
Leica
Acid Alcohol 0.5 %
Leica
Acid Alcohol 1.0 %
Customer/User- Hydrochloric Acid 2 %
defined
PAS
Leica
Periodic Acid 0.5 %
Customer/User- Periodic Acid (up to 10 %)
defined
Diastase-PAS
Leica
Schiff's Reagent
Leica
Diastase-Solution (37 °C)
Leica HistoCore SPECTRA ST
 Use in heated reagent
cuvette: 37 °C
129
Appendix 1
A1
DRAFT
2014 08 21
2014-08-21
2014-08-2
Compatible reagents (continued)
Staining method or reagent
agent group
grou
Reagent name
na
Alcian Blue-PAS
Alcian
cian Blue-Solution
Alcian Blue
Leica
Notes
Leica
Alcian Blue and Leica
other Staining
Methods
Nuclear fast Red
Gomori Trichrome Leica
Blue and Green
Collagen Staining
Weigert Hematoxylin
(A+B Solution)
Gomori Trichrome Blue Stain
1 % Acetic Acid
Light Green
Perl's Iron
Staining
Leica
Potassium-Ferrocyanide
Solution
Hydrochloride Acid Solution
Giemsa
Leica
 Must not come into contact with metal ions
 Only for use with coated
5 series rack clips
Methanol Solution A
Stain 1 Solution B
Stain 2 Solution C
Buffer Solution D
Congo Red
Amyloid Stain
Leica
Congo Red Solution
Leica
1 % Potassium Hydroxide
Solution
Customer/User- Saturated Lithium Carbonate
defined
Solution
130
Instructions for Use V 0.5 RevC - 08/2014
A1
DRAFT
2014-08-21
014
4 08 21
4-08-2
21
Appendix 1
Compatible reagents (continued)
Staining method or reagent group
Reagent name
Alcian Yellow
for Helicobacter
Pylori
Alcian Yellow-Solution
(0.25 %Alcian Yellow)
Leica
Notes
Note
5 % Periodic Acid
5 % Sodium Metabisulfite
6.8 pH Sorensen Buffer
Toluidin Blue Solution
Elastic Stain/Ver- Leica
hoeff's van Gieson
5 % Alcoholic Hematoxylin
10 % Ferric Chloride
Lugol's Iodin Solution
2 % Ferric Chloride
Verhoeff's Staining Solution
Van Gieson's Stain
Leica HistoCore SPECTRA ST
131
Appendix 1
A1
DRAFT
2014 08 21
2014-08-21
2014-08-2
Compatible reagents (continued)
Staining method or reagent
agent group
grou
Reagent name
na
Notes
Gomori Methena- Leica
mine Silver Stain
Modified
odified Chromic Acid (up 
 Usee in heated reagent
to 5 %)
cuvette: 55 °C

Must
not come into conMethenamine Borax
tact with metal ions
0.5 % Silver Nitrate
 Only for use with coated
5 series rack clips
1 % Sodium Bisulfate
1 % Gold Chloride
2 % Sodium Thiosulfate
Light Green
Papanicolaou
(PAP)
132
Leica
EA-50
Leica
Orange G-6
Leica
EA-65 (Secondary Counter
Stain)
Instructions for Use V 0.5 RevC - 08/2014
A1
DRAFT
2014-08-21
014
4 08 21
4-08-2
21
Appendix 1
Compatible reagents (continued)
Staining method or reagent group
Reagent name
Notes
Note
Schmorl's
Reduction
Schmorl's Solution
 Only
O for use with coated
5 series rack clips
(MĂźller) Colloidal
Iron
Other reagents
Colloidal Iron Solution
 Only for use with coated
5 series rack clips
Ferrocyanide-Hydrochloric
Acid Solution
Customer/User- Anilin Blue
defined
Customer/User- Methylene Blue
defined
Customer/User- Fast Green
defined
Customer/User- Carmin
defined
Customer/User- Southgate or Mayer's Micidefined
carmine
Customer/User- Neutral Red
defined
Customer/User- Safranin
defined
Leica HistoCore SPECTRA ST
133
Appendix 1
A1
DRAFT
2014 08 21
2014-08-21
2014-08-2
Compatible reagents (continued)
Staining method or reagent
agent group
grou
Reagent name
na
Solvent
Leica/Customer
Leica/Custom
Xylene,
ene, Toluene
Leica
Leica ST Ultra
Xylene Substitute based on
Alipahtic Hydrocarbons
Leica
Leica Clearene
Limonene based Xylene
Substitute
Merck
Merck Neo-Clear
Xylene Substitute based on
Alipahtic Hydrocarbons
Carl Roth
RotiÂŽ-Histol
Limonene based Xylene
Substitute
Alcohol
Notes
Richard-Allen Sci./ Clear-Rite 3
Thermo Sci.
Xylene Substitute based on
Alipahtic Hydrocarbons
Richard-Allen Sci./ Citrus Clearing Solvent
Thermo Sci.
Limonene based Xylene
Substitute
Leica/Customer
2-Propanol (Isopropanol)
Leica/Customer
Ethanol
Methanol
Richard-Allen Sci./ Dehydrant
Thermo Sci.
Ethyl Alcohol, Methyl Alcohol
Richard-Allen Sci./ Flex
Thermo Sci.
Isopropyl, Alcohol, Methyl
Alcohol
Usual Acids (Max. Customer/User- Acetic Acid (up to 15 %)
Concentration)
defined
Hydrochloric Acid (up to 5 %)
Picric Acid (up to 3 %)
134
Instructions for Use V 0.5 RevC - 08/2014
DRAFT
2014-08-21
DRAFT
2014-08-21
www.LeicaBiosystems.com
ms com
Leica Biosystems Nussloch GmbH
Heidelberger Strasse 17–19
D- 69226 Nussloch
Phone: +49 - (0) 6224 - 143 0
Fax: +49 - (0) 6224 - 143 268
Web: www.LeicaBiosystems.com

---

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xmp.iid:BEC7E13C567CE311983BB6B8231A4CB0, xmp.iid:7877D8AE5A7CE311983BB6B8231A4CB0, xmp.iid:389A2996067DE311836AF490B1F11ACD, xmp.iid:0F469796067DE311836AF490B1F11ACD, xmp.iid:F800048A227DE311836AF490B1F11ACD, xmp.iid:B41480A7D27DE311A85FB0AB56A71202, xmp.iid:84E816E3E07DE311A85FB0AB56A71202, xmp.iid:CB481210E57DE311A85FB0AB56A71202, xmp.iid:DF42B7AAEB7DE311A85FB0AB56A71202, xmp.iid:ABA4BBB5F07DE3118126BD545BD61288, xmp.iid:1689F6B9907EE311964F9D466C2AF736, xmp.iid:5FCBB4649D7EE311964F9D466C2AF736, xmp.iid:D2C097FCAB7EE311964F9D466C2AF736, xmp.iid:1F3D5CAEB57EE311964F9D466C2AF736, xmp.iid:8EA9FCA0B77EE311964F9D466C2AF736, xmp.iid:8FA9FCA0B77EE311964F9D466C2AF736, xmp.iid:FEBFE92FBA7EE311964F9D466C2AF736, xmp.iid:AA0231BA3D7FE311AE37E8975F6DAA01, xmp.iid:2F409CBA3D7FE311AE37E8975F6DAA01, xmp.iid:03C72E0A557FE311AE37E8975F6DAA01, xmp.iid:2868B0A8707FE311AEBF8360928E9785, xmp.iid:95EDF5187A7FE311AEBF8360928E9785, xmp.iid:335F62B2BB81E3118784B119EC5B197E, xmp.iid:A7D15CC6D181E3118784B119EC5B197E, xmp.iid:4D8430ADD881E3118784B119EC5B197E, xmp.iid:CC2730F4DA81E3118784B119EC5B197E, xmp.iid:FFAFF8F9DA81E3118784B119EC5B197E, xmp.iid:96753949DB81E3118784B119EC5B197E, xmp.iid:297456FADB81E3118784B119EC5B197E, xmp.iid:F17B54A47D82E3118A0DE61B960160C9, xmp.iid:1633C8DB8982E3118A0DE61B960160C9, xmp.iid:8B998CDF9E82E3118A0DE61B960160C9, xmp.iid:BA53D45CA782E3118A0DE61B960160C9, xmp.iid:691AD4E4A982E3118A0DE61B960160C9, xmp.iid:3F35298B3183E311B3299E51950EF9BC, xmp.iid:69E6E5425983E311B3299E51950EF9BC, xmp.iid:E14BCF1E7083E311B3299E51950EF9BC, xmp.iid:BC95435B0384E311A8B3CF9F37AF9A76, xmp.iid:B055A55B0384E311A8B3CF9F37AF9A76, xmp.iid:A9D75A4C0884E311A8B3CF9F37AF9A76, xmp.iid:EB9DC8413684E311A8B3CF9F37AF9A76, xmp.iid:6C072520D884E311B390B5EBFC0BEF7C, xmp.iid:E0648420D884E311B390B5EBFC0BEF7C, xmp.iid:6AC49D99DC84E311B390B5EBFC0BEF7C, xmp.iid:6015DB9BF287E311A1DBB85AF502D60F, xmp.iid:17C2C59E0D88E311A1DBB85AF502D60F, xmp.iid:2604B9592588E311A1DBB85AF502D60F, xmp.iid:C6C3BCE9AE88E311ABABC06F489946EA, xmp.iid:398CBFC4E388E311ABABC06F489946EA, xmp.iid:75D7DA57EB88E311ABABC06F489946EA, xmp.iid:5917053AF188E311ABABC06F489946EA, xmp.iid:C88A90417889E311BCBAE8F914DB96D6, xmp.iid:7E5C62427889E311BCBAE8F914DB96D6, xmp.iid:352EFAE0A889E311BCBAE8F914DB96D6, xmp.iid:A565AD6D6F8AE311A0C4EA88D40F4889, xmp.iid:640D1C6D7E8AE311A0C4EA88D40F4889, xmp.iid:1576B4CABE8CE311AD7B9A376AC48221, xmp.iid:2E7111CBBE8CE311AD7B9A376AC48221, xmp.iid:306B8A1EC28CE311AD7B9A376AC48221, xmp.iid:E6C8F740DF8CE311A51EA8BFACE978E9, xmp.iid:01360484AA8DE311853DB821065120FF, xmp.iid:802F8084AA8DE311853DB821065120FF, xmp.iid:5DFECE5F628EE311B99BC4DCD42BDCAE, xmp.iid:9E0F5260628EE311B99BC4DCD42BDCAE, xmp.iid:5C9FE024748EE311B99BC4DCD42BDCAE, xmp.iid:260B3C04378FE3118119C016C8AD424D, xmp.iid:432E8140FC8FE311A74DC1F6E9FC3A62, xmp.iid:4963F840FC8FE311A74DC1F6E9FC3A62, xmp.iid:3FE3EC7B6192E311BBC4DF894C45DCCA, xmp.iid:097E0FCE2B93E3119E6EEC8ACBC549DA, xmp.iid:055265CE2B93E3119E6EEC8ACBC549DA, xmp.iid:8B9F21CAE093E311B6EFD465324967CE, xmp.iid:516F50E4BB94E31181FCF513AB78912B, xmp.iid:5B566B5B5A95E311985DFCB9D52DAC37, xmp.iid:2B2CC15B5A95E311985DFCB9D52DAC37, xmp.iid:B7A4AC236E95E311985DFCB9D52DAC37, xmp.iid:9D4EC3D06F95E311985DFCB9D52DAC37, xmp.iid:87A503957095E311B5918705A4119DBF, xmp.iid:E4E9F7F5B597E311B118F58137232D7F, xmp.iid:7C4576F6B597E311B118F58137232D7F, xmp.iid:276073AFCA97E311A49383EEE36E426B, xmp.iid:34C12505E297E31186A1DB63DD46B55E, xmp.iid:E0DFB85AAB98E311BB6E878FA69CCBA2, xmp.iid:89C8025BAB98E311BB6E878FA69CCBA2, xmp.iid:932184C2209EE3118D19931EF58D5D0D, xmp.iid:95DA64772A9EE3118D19931EF58D5D0D, xmp.iid:89392EBC2A9EE3118D19931EF58D5D0D, xmp.iid:619CA5FAF29EE31184D5FB3FB61654B7, xmp.iid:680EF9FAF29EE31184D5FB3FB61654B7, xmp.iid:3F20902C9E9FE3118F0CA6F2BE04A0DA, xmp.iid:3807F92C9E9FE3118F0CA6F2BE04A0DA, xmp.iid:445EE14CB59FE3118F0CA6F2BE04A0DA, xmp.iid:A335C1B27AA0E311A2D7FC1D6F7908D3, xmp.iid:B90655B37AA0E311A2D7FC1D6F7908D3, xmp.iid:F1AB51F3CDA2E311B3E983304B2B223C, xmp.iid:0BA7AEF3CDA2E311B3E983304B2B223C, xmp.iid:4A6C8210DCA2E311B3E983304B2B223C, xmp.iid:F0EF652F9AA3E311A181DE97823A84A9, xmp.iid:2DAC470646A4E3119DBBDCD8EC22C663, xmp.iid:98F2F00646A4E3119DBBDCD8EC22C663, xmp.iid:1AA339FC42A8E31186CC920556928202, xmp.iid:4DD8B0FC42A8E31186CC920556928202, xmp.iid:FA1C50D556A8E31186CC920556928202, xmp.iid:09C29F575FA8E31186CC920556928202, xmp.iid:F4F5CD7AEFA8E311AC41AC7307B55945, xmp.iid:AFE5ED5B1EA9E311B2E8C67FE1903B30, xmp.iid:267AA55C1EA9E311B2E8C67FE1903B30, xmp.iid:28C9B82E27A9E311B2E8C67FE1903B30, xmp.iid:CF92A9F928A9E311B2E8C67FE1903B30, xmp.iid:18F0E746D2A9E311B2F2C016A8F5153E, xmp.iid:D69C5547D2A9E311B2F2C016A8F5153E, xmp.iid:D79C5547D2A9E311B2F2C016A8F5153E, xmp.iid:6014A6CCD4A9E311B2F2C016A8F5153E, xmp.iid:96814CE9D8A9E311B2F2C016A8F5153E, xmp.iid:8FE98573D9A9E311B2F2C016A8F5153E, xmp.iid:A3DFA291E8A9E311B2F2C016A8F5153E, xmp.iid:DB286FE6F2A9E311B2F2C016A8F5153E, xmp.iid:99E010887BAAE311BF62FDBF49521BCD, xmp.iid:233F42D07CAAE311BF62FDBF49521BCD, xmp.iid:243F42D07CAAE311BF62FDBF49521BCD, xmp.iid:030FCECABBAAE311BF62FDBF49521BCD, xmp.iid:389A333A54ABE311AF40B657127FD723, xmp.iid:399A333A54ABE311AF40B657127FD723, xmp.iid:072396F75FABE311AF40B657127FD723, xmp.iid:5082D6F75FABE311AF40B657127FD723, xmp.iid:97BBE0AA6EABE311AF40B657127FD723, xmp.iid:40C725C785ABE311AF40B657127FD723, xmp.iid:D9BF5847B8ADE311B4A8D78A3EB48C35, xmp.iid:2143DE47B8ADE311B4A8D78A3EB48C35, xmp.iid:ADDCAE64DEADE311B4A8D78A3EB48C35, xmp.iid:2DCC29C064AEE311A9DAEA9B4ED88D43, xmp.iid:0D8A8BC064AEE311A9DAEA9B4ED88D43, xmp.iid:3B459F33A2AEE311A9DAEA9B4ED88D43, xmp.iid:25A2B1BEA2AEE311A9DAEA9B4ED88D43, xmp.iid:216203EF60AFE31191AFE36849AB2B75, xmp.iid:0ACED2EF60AFE31191AFE36849AB2B75, xmp.iid:9B9D9FED6CAFE31191AFE36849AB2B75, xmp.iid:ED05793D6EAFE31191AFE36849AB2B75, xmp.iid:26A22F776EAFE31191AFE36849AB2B75, xmp.iid:08FA225273AFE31191AFE36849AB2B75, xmp.iid:688966FAF5AFE311BC3E9E83BF0480AC, xmp.iid:DE65EEFAF5AFE311BC3E9E83BF0480AC, xmp.iid:800240C3FCAFE311BC3E9E83BF0480AC, xmp.iid:8B65118502B0E311BC3E9E83BF0480AC, xmp.iid:9F6E37BD02B0E311BC3E9E83BF0480AC, xmp.iid:A06E37BD02B0E311BC3E9E83BF0480AC, xmp.iid:DA20894C29B0E311BC3E9E83BF0480AC, xmp.iid:226F810434B0E311BC3E9E83BF0480AC, xmp.iid:78790107F7B0E311957DAE0EC672F863, xmp.iid:EDD39E07F7B0E311957DAE0EC672F863, xmp.iid:29FD771EF9B0E311957DAE0EC672F863, xmp.iid:74B366370CB4E311B223A6295CD2B719, xmp.iid:44970D380CB4E311B223A6295CD2B719, xmp.iid:D5EB08AC20B4E311B223A6295CD2B719, xmp.iid:DE849DD1EAB4E3119C01E99985668986, xmp.iid:2EE059D2EAB4E3119C01E99985668986, xmp.iid:CE100575EDB4E3119C01E99985668986, xmp.iid:8386D71D9AB5E311B5439AF90383BF57, xmp.iid:BCD28B1F9AB5E311B5439AF90383BF57, xmp.iid:BDD28B1F9AB5E311B5439AF90383BF57, xmp.iid:A48C093E70B6E3118330E61AEB3E7FFA, xmp.iid:BBACCA3E70B6E3118330E61AEB3E7FFA, xmp.iid:7DA74ADC85B9E311BA5A84594D09EADA, xmp.iid:2BF1B5DC85B9E311BA5A84594D09EADA, xmp.iid:3B8E6C338BB9E311BA5A84594D09EADA, xmp.iid:921DD5838DB9E311BA5A84594D09EADA, xmp.iid:6E2CF38C8DB9E311BA5A84594D09EADA, xmp.iid:CD61AA5593B9E311BD4FACEA6385F7E9, xmp.iid:AB3C7BE995B9E311BD4FACEA6385F7E9, xmp.iid:68A9CA8A96B9E311BD4FACEA6385F7E9, xmp.iid:12BF7521CFD9E311A24BF3A318806941, xmp.iid:9ACD4D23CFD9E311A24BF3A318806941, xmp.iid:A6EA2134CFD9E311A24BF3A318806941, xmp.iid:2FF6715E82DAE3119BEE927A1191B66C, xmp.iid:243EFC5E82DAE3119BEE927A1191B66C, xmp.iid:253EFC5E82DAE3119BEE927A1191B66C, xmp.iid:33C84528A1DAE3119BEE927A1191B66C, xmp.iid:70DF10488BE1E311BAEBE65726103676, xmp.iid:EC31AE2C9CE1E311BAEBE65726103676, xmp.iid:1A26FB959CE1E311BAEBE65726103676, xmp.iid:740056D171E2E311B631F9E9067C2635, xmp.iid:C870C8D171E2E311B631F9E9067C2635, xmp.iid:70E692C5D8E4E311BCBDDD388FB49849, xmp.iid:A1AEC1C6D8E4E311BCBDDD388FB49849, xmp.iid:BD40160485E5E3119E3D9C4914D2EFE0, xmp.iid:BE40160485E5E3119E3D9C4914D2EFE0, xmp.iid:55839BA893E5E3119E3D9C4914D2EFE0, xmp.iid:473BA8FD98E5E3119E3D9C4914D2EFE0, xmp.iid:9807EBDD44E6E311BFF2B803225817E3, xmp.iid:DD757CDE44E6E311BFF2B803225817E3, xmp.iid:6028E23B56E6E311A0A9BD5AE913A01D, xmp.iid:6128E23B56E6E311A0A9BD5AE913A01D, xmp.iid:967678A257E6E3118189C37471556D9D, xmp.iid:977678A257E6E3118189C37471556D9D, xmp.iid:3C5C3ED263E6E311B429DB440BD582AE, xmp.iid:2379FFD263E6E311B429DB440BD582AE, xmp.iid:67318E144DEAE31189FEF30026AE5914, xmp.iid:CF1273154DEAE31189FEF30026AE5914, xmp.iid:32F7EC1A4DEAE31189FEF30026AE5914, xmp.iid:D86B1B0855EAE31189FEF30026AE5914, xmp.iid:93D8174106EBE3118D36C0D8471A8553, xmp.iid:1647A94106EBE3118D36C0D8471A8553, xmp.iid:E96ADF9C14EBE3118D36C0D8471A8553, xmp.iid:8A10F64E1DEBE3118D36C0D8471A8553, xmp.iid:4BCE68CD1DEBE3118D36C0D8471A8553, xmp.iid:1C8E523F1EEBE3118D36C0D8471A8553, xmp.iid:3BBA980495F0E311AA5EAB079C03488C, 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History When                    : 2013:11:26 10:44:20+01:00, 2013:11:28 07:41+01:00, 2013:12:02 12:39:56+01:00, 2013:12:02 12:39:56+01:00, 2013:12:02 13:02:20+01:00, 2013:12:02 13:04:16+01:00, 2013:12:02 13:04:19+01:00, 2013:12:02 16:00:20+01:00, 2013:12:03 08:51:46+01:00, 2013:12:03 09:02:07+01:00, 2013:12:03 09:02:08+01:00, 2013:12:03 09:09:45+01:00, 2013:12:03 09:09:45+01:00, 2013:12:03 10:19:08+01:00, 2013:12:05 11:35:07+01:00, 2013:12:05 13:08:54+01:00, 2013:12:05 13:08:54+01:00, 2013:12:05 13:42:41+01:00, 2013:12:05 13:42:42+01:00, 2013:12:05 13:44:49+01:00, 2013:12:05 13:44:49+01:00, 2013:12:05 13:52:46+01:00, 2013:12:09 07:50:12+01:00, 2013:12:09 08:29:04+01:00, 2013:12:09 08:29:04+01:00, 2013:12:09 08:32:13+01:00, 2013:12:09 08:54:48+01:00, 2013:12:09 08:54:48+01:00, 2013:12:09 08:58:13+01:00, 2013:12:09 11:37:11+01:00, 2013:12:09 12:07:32+01:00, 2013:12:09 12:07:32+01:00, 2013:12:09 12:18:09+01:00, 2013:12:09 13:14:40+01:00, 2013:12:09 15:12:35+01:00, 2013:12:11 13:22:10+01:00, 2013:12:11 13:22:11+01:00, 2013:12:11 13:42:43+01:00, 2013:12:11 14:25:40+01:00, 2013:12:11 15:11:06+01:00, 2013:12:11 15:11:58+01:00, 2013:12:11 15:48:06+01:00, 2013:12:12 12:42:53+01:00, 2013:12:12 15:36:42+01:00, 2014:01:10 12:43:39+01:00, 2014:01:10 12:43:40+01:00, 2014:01:13 14:25:58+01:00, 2014:01:13 14:57:47+01:00, 2014:01:14 11:28:19+01:00, 2014:01:14 11:28:20+01:00, 2014:01:14 14:48:24+01:00, 2014:01:15 11:49:05+01:00, 2014:01:15 13:30:58+01:00, 2014:01:15 14:00:52+01:00, 2014:01:15 14:48:08+01:00, 2014:01:15 15:24:14+01:00, 2014:01:16 10:29:41+01:00, 2014:01:16 12:00:21+01:00, 2014:01:16 13:44:49+01:00, 2014:01:16 14:54:13+01:00, 2014:01:16 15:08:09+01:00, 2014:01:16 15:26:27+01:00, 2014:01:16 15:26:28+01:00, 2014:01:17 07:08:04+01:00, 2014:01:17 07:08:05+01:00, 2014:01:17 09:54:57+01:00, 2014:01:17 13:12:39+01:00, 2014:01:17 14:20:13+01:00, 2014:01:20 11:14:50+01:00, 2014:01:20 13:52:52+01:00, 2014:01:20 14:42:17+01:00, 2014:01:20 14:58:35+01:00, 2014:01:20 14:58:44+01:00, 2014:01:20 15:00:57+01:00, 2014:01:20 15:05:54+01:00, 2014:01:21 10:23:09+01:00, 2014:01:21 11:50:36+01:00, 2014:01:21 14:21:01+01:00, 2014:01:21 15:21:48+01:00, 2014:01:21 15:39:55+01:00, 2014:01:22 07:50:56+01:00, 2014:01:22 12:35:14+01:00, 2014:01:22 15:18:52+01:00, 2014:01:23 08:52:50+01:00, 2014:01:23 08:52:50+01:00, 2014:01:23 09:28:12+01:00, 2014:01:23 14:57:11+01:00, 2014:01:24 10:15:53+01:00, 2014:01:24 10:15:54+01:00, 2014:01:24 10:47:55+01:00, 2014:01:28 12:16:22+01:00, 2014:01:28 12:16:23+01:00, 2014:01:28 15:06:15+01:00, 2014:01:29 13:49:18+01:00, 2014:01:29 13:49:19+01:00, 2014:01:29 14:43:32+01:00, 2014:01:29 15:25:39+01:00, 2014:01:30 07:32:14+01:00, 2014:01:30 07:32:15+01:00, 2014:01:30 13:20:17+01:00, 2014:01:31 14:48:54+01:00, 2014:01:31 14:48:55+01:00, 2014:02:03 11:34:42+01:00, 2014:02:03 11:34:42+01:00, 2014:02:03 11:58:31+01:00, 2014:02:03 15:27:04+01:00, 2014:02:04 15:42:05+01:00, 2014:02:04 15:42:05+01:00, 2014:02:05 13:38:11+01:00, 2014:02:05 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