Leica Biosystems Nussloch SPECTRAST User Manual
4-
08-21
Instructions for Use
Leica HistoCore SPECTRA ST
Staining machine
V 0.5 RevC - 08/2014
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.
4-
08-21
NOTE
p
p
-entific knowledge and sta
as we understand it following
gg
gg
tdetails of the present Inst
no be considered warran
TE
The information, numerical data, notes and value
judgments contained in this manual represent the
current state of scientific knowledge and state-ofthe-art technology as we understand it following
thorough investigation in this field.
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.
entific knowledge and state-of
as we understand it following
Statements, drawings, illustrations and other
information regarding the contents or technical
details of the present Instructions for Use are not
details of the present Ins
to be considered warranted characteristics of
to be considered warra
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.
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
© Leica Biosystems Nussloch GmbH
1
Table of Contents
Name
nt Name
sand their meanin
....................................................................
nt type
1. Important Information ................................................................................................................. 5
1.1 Instrument Name .......................................................................................................................... 5
1.2 Symbols and their meanings....................................................................................................... 5
1.3 Instrument type ........................................................................................................................... 13
1.4 Qualification of personnel ......................................................................................................... 13
1.5 Intended use of instrument ....................................................................................................... 13
2. Safety ......................................................................................................................................... 14
2.1 Safety notes ................................................................................................................................. 14
2.2 Warnings ...................................................................................................................................... 16
2.3 Safety features on the instrument ........................................................................................... 20
3. Instrument Components and Specifications ......................................................................... 21
3.1 Standard delivery—packing list............................................................................................... 21
3.2 Technical Data ............................................................................................................................ 22
3.3 Overview ...................................................................................................................................... 24
4. Installation and Starting Up ..................................................................................................... 27
4.1 Installation site requirements ................................................................................................... 27
4.2 Running water connection ........................................................................................................ 28
4.2.1 Joint connection of all 6 rinsing water stations .................................................................... 29
4.2.2 Combined connection 4+2 rinsing water stations ................................................................. 30
4.2.3 Wastewater connection ............................................................................................................ 31
4.3 Electrical Connection ................................................................................................................. 32
4.3.1 Using an external uninterruptible power supply (UPS) ........................................................ 33
4.4 Exhaust air connection .............................................................................................................. 33
4.5 Switching the instrument on and off ....................................................................................... 34
and their meaning
nt type
........................................................................................
...........................................................................................
.....................................................................
5. Operation ..................................................................................................................................... 35
5.1 User interface – overview ......................................................................................................... 35
5.2 Status bar elements ................................................................................................................... 36
5.3 Process status display ............................................................................................................... 37
5.4 Displaying the drawers .............................................................................................................. 39
5.5 Main menu-overview ................................................................................................................. 40
5.5.1 The keyboard ............................................................................................................................... 41
5.6 User settings ................................................................................................................................ 43
5.7 Basic settings .............................................................................................................................. 45
5.7.1 Language settings ...................................................................................................................... 46
5.7.2 Country-specific settings .......................................................................................................... 46
5.7.3 Date and time .............................................................................................................................. 47
2
Instructions for Use V 0.5 RevC - 08/2014
Table of Contents
the oven
g the oven
............................................................................
)ement speed - up/down movement (agitatio
............
managemen
............................................................................
5.7.4 Alarm and signal tones .............................................................................................................. 47
5.7.5 Setting the oven .......................................................................................................................... 49
5.7.6 Movement speed - up/down movement (agitation) .............................................................. 50
5.7.7 Data management ...................................................................................................................... 51
5.7.8 Service access ............................................................................................................................ 54
5.7.9 Event view .................................................................................................................................... 54
5.7.10 Network settings ......................................................................................................................... 55
5.8 Reagent list .................................................................................................................................. 56
5.8.1 Define heated reagent (optional) ............................................................................................. 57
5.8.2 Creating a new reagent ............................................................................................................. 58
5.8.3 Process classes .......................................................................................................................... 60
5.9 Staining program ........................................................................................................................ 63
5.9.1 Staining program - general settings ........................................................................................ 64
5.9.2 Leica staining programs (preinstalled) ...................................................................................65
5.9.3 Adapting the Leica H&E staining program ............................................................................. 66
5.9.4 User-defined staining programs ............................................................................................. 66
5.9.5 Creating a new staining program............................................................................................. 67
5.9.6 Inserting a new program step (continued) ............................................................................. 69
5.9.7 Resorting a program step .......................................................................................................... 70
5.9.8 Prioritizing programs .................................................................................................................. 71
5.9.9 Creating a bathlayout ................................................................................................................. 72
5.9.10 Adjusting a bathlayout ............................................................................................................... 75
ment speed - up/down movement (agitation
management
................................................................................
........................
6. Daily Instrument Setup ........................................................................................................... 78
6.1 Preparing the instrument for daily setup ................................................................................ 78
6.2. Daily setup of the instrument .................................................................................................... 79
6.2.1 Preparation and handling of reagent cuvettes ...................................................................... 79
6.2.2 Automatic fill level scan ............................................................................................................ 81
6.3 Reagent management system (RMS) ...................................................................................... 82
6.4 Station features ........................................................................................................................... 84
6.5 Prepare slide rack ...................................................................................................................... 89
6.6 The staining process .................................................................................................................. 91
6.6.1 Start the staining process ......................................................................................................... 91
6.7.2 Monitoring the staining process .............................................................................................. 93
6.7.3 Staining process completed ..................................................................................................... 94
6.7.4 Canceling the staining program ............................................................................................... 95
6.7.5 Operation as a workstation ....................................................................................................... 96
Leica HistoCore SPECTRA ST
3
Table of Contents
notes about this instrument cleaning
t notes about this instrument cleani
............
nhscreen
......................................................................................
7. Cleaning and Maintenance ....................................................................................................98
7.1 Important notes about this instrument cleaning ................................................................... 98
7.1.1 Exterior surfaces, varnished surfaces, instrument cover.................................................... 98
7.1.2 TFT touchscreen ......................................................................................................................... 98
7.1.3 Interior and drain pan ................................................................................................................ 99
7.1.4 Transport arms ............................................................................................................................ 99
7.1.5 Reading module for specimen slides ...................................................................................... 99
7.1.6 Input and output drawers ........................................................................................................ 100
7.1.7 Dry transfer station ................................................................................................................... 100
7.1.8 Transfer station (optional) ....................................................................................................... 100
7.1.9 Reagent cuvettes, rinsing water cuvettes and heated cuvettes (optional) .................... 101
7.1.10 Rack and clip ............................................................................................................................. 102
7.1.11 Water drain ................................................................................................................................ 103
7.1.12 Water drain hose ...................................................................................................................... 104
7.1.13 Water intake filter – changing the filter cartridge .............................................................. 104
7.1.14 Replacing the active carbon filter.......................................................................................... 105
7.1.15 Cleaning the ovens ................................................................................................................... 106
7.1.16 Oven air filter ............................................................................................................................. 107
7.2 Recommended maintenance and cleaning intervals ......................................................... 108
8. Malfunctions and Troubleshooting ...................................................................................... 111
8.1 Fault remedies for instrument malfunctions ........................................................................ 111
8.2 Power failure scenario ............................................................................................................ 114
8.3 Replace main fuses .................................................................................................................. 115
surfaces, varnished surfaces, instrument cover
hscree
.........................................................................................
...................................
....................
9. Instrument Components and Specifications ..................................................................... 116
9.1 Optional instrument components ........................................................................................... 116
9.2 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
4
Instructions for Use V 0.5 RevC - 08/2014
1.1 Instrument Name
name of the device is HistoCore SPECTRA ST. The device is ca
he Instructions for Use are well legible.
The full name of the device is HistoCore SPECTRA ST. The device is called SPECTRA ST to ensure that the Instructions for Use are well legible.
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: Title of the symbol: Caution
Description: Indicates the need for the user to consult the instruc-
tions for use for important cautionary information
such as warnings and precautions that cannot, for
a variety of reasons, be presented on the medical
device itself.
Symbol: Title of the symbol: Notes
Description: This symbol indicates important information for the
user. The notes appear in a gray and are marked by
this symbol.
1. Important Information
Symbol: Title of the symbol: Item numbers
Description: Numbers and parentheses refer to item numbers in
the illustrations.
Symbol: Title of the symbol: Function keys
Description: Function keys that must be pushed on the touch-
screen or activated in the software are shown in
BOLD.
Symbol: Title of the symbol: Leica Biosystems GmbH company logo
Description: Indicates the trademark of the company.
Leica HistoCore SPECTRA ST
5
1. Important Information
tle of the symb
eWarning, hot surface
:Description
mument surfaces which becom
1.2 Symbols and their meanings (continued)
Symbol: Title of the symbol: Warning, hot surface
Symbol: Title of the symbol: Manufacturer
Symbol: Title of the symbol: Date of Manufacture
Symbol: Title of the symbol: CE Compliance
Symbol: Title of the symbol: In vitro diagnostic medical device
Title of the symbol:
Description: Instrument surfaces which become hot during opera-
escription
Description: Indicates the medical device manufacturer, as de-
Description: Indicates the date when the medical device was
Description: The CE marking is the manufacturer's declaration
Description: Indicates a medical device that is intended to be used
Warning, hot surfac
Instrument surfaces which beco
tion are marked with this symbol. Avoid direct contact
to prevent risk of burning.
fined in EU Directives.
manufactured.
that the medical product meets the requirements of
the applicable EC directives.
as an in vitro diagnostic medical device.
Symbol: Title of the symbol: China ROHS
6
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
1.2 Symbols and their meanings (continued)
lWEEE Symbo
:Descript
he WEEE symbol, indicating s
1. Important Information
Symbol: Title of the symbol: WEEE Symbol
Symbol: Title of the symbol: Alternating current
Symbol: Title of the symbol: PE terminal
Symbol: Title of the symbol: Earth (Ground) terminal
Symbol: Title of the symbol: Article number
Title of the symbol:
Description: The WEEE symbol, indicating separate collection for
escription
Description:
Description:
Description:
Description: Indicates the manufacturer's catalogue number so
WEEE Symbo
The WEEE symbol, indicating
WEEE - Waste of electrical and electronic equipment, consists of the crossed-out wheeled bin (§ 7
ElektroG).
that the medical device can be identified.
Symbol: Title of the symbol: Serial Number
Symbol: Title of the symbol: Consult instructions for use
Leica HistoCore SPECTRA ST
Description: Indicates the manufacturer's serial number so that a
specific medical device can be identified.
Description: Indicates the need for the user to consult the instruc-
tions for use.
7
1. Important Information
tle of the symb
)(Power)
pply i
dpower supply is connected
1.2 Symbols and their meanings (continued)
Symbol: Title of the symbol: ON (Power)
Symbol: Title of the symbol: OFF (Power)
Symbol: Title of the symbol: Caution, possibility of electronic shock
Symbol: Title of the symbol: Caution: danger of crushing
Symbol: Title of the symbol: IPPC symbol
Title of the symbol:
Description: The power supply is connected upon pushing the
escription:
Description: The power supply is disconnected upon pushing the
Description Instrument surfaces or areas which become ener-
Description: The IPPC symbol includes
ON (Power
e power su
power switch.
power switch.
gized during operation are marked with this symbol.
Therefore, direct contact is to be avoided.
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)
s connecte
Symbol: Title of the symbol: Fragile, handle with care
8
Description: Indicates a medical device that can be broken or
damaged if not handled carefully.
Instructions for Use V 0.5 RevC - 08/2014
1.2 Symbols and their meanings (continued)
:Descript
handicates a medical device tha
1. Important Information
Symbol: Title of the symbol: Keep dry
Symbol: Title of the symbol: Do not stack
Symbol: Title of the symbol: This way up
Symbol: Title of the symbol: Temperature limit for transport
Title of the symbol:
Description: Indicates a medical device that needs to be protected
escription
Description: Stacking of the transport package is not allowed and
Description: Indicates correct upright position of the transport
Description: Indicates the temperature limits for transport to
eep dry
ndicates a medical device t
from moisture.
no load should be placed on the transport package.
package.
which the medical device can be safely exposed.
Symbol: 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
9
1. Important Information
tle of the symb
ycates the range of humidity
1.2 Symbols and their meanings (continued)
Symbol: Title of the symbol: Humidity limitation for transport and storage
Title of the symbol:
Description: Indicates the range of humidity for transport and
escription:
Humidity limitation for transport
Indicates the range of humidit
storage to which the medical device can be safely
exposed.
Appearance: 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.
Appearance: 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.
10
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.
Instructions for Use V 0.5 RevC - 08/2014
1. Important Information
1.2 Symbols and their meanings (continued)
US/Canada only:
This device complies with Part 15 of the FCC Rules and with Industry Canada
This device complies with Part 15 of the FCC Rules an
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
FCC ID: 2AAPD-SPECTRAST
IC: 12028A-SPECTRAST
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.
that may cause undesired operation.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables
aux appareils radio exempts de licence. L'exploitation est autorisée aux
deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique
subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
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
1. Important Information
nese Radio Law and Japanese Te
1.2 Symbols and their meanings (continued)
Japan only:
Japanese Radio Law and Japanese Telecommunications
apanese Radio Law and Japanese 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:
12
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
Instructions for Use V 0.5 RevC - 08/2014
1.3 Instrument type
cion provided in these Ins
ue applies only to the instru
1. Important Information
All information provided in these Instructions for Use applies only to the instru-
ion provided in these Instru
e applies only to the instr
ment type indicated on the title 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
The Leica HistoCore SPECTRA ST must only be operated by authorized personnel compre-
hensively 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).
Fig. 1
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
safety and caution notes in this chapter must be observed at
ad these notes even if you are already familiar with the operat
2.1 Safety notes
The safety and caution notes in this chapter must be observed at all times. Be sure to
The protective devices located on the instrument and the accessories must not be re-
Only qualified service personnel authorized by Leica may repair the instrument and
Residual risks
The instrument has been designed and constructed with the latest state-of-the-art
The instrument may be used only as intended and only if all of its safety features are
If malfunctions are to occur that can impede safety, the instrument must be put out of
Only original spare parts and permitted original Leica accessories may be used.
read these notes even if you are already familiar with the operation and use of other
Leica products.
moved or modified.
access its internal components.
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.
in proper working condition.
operation immediately and the responsible Leica service technician must be notified.
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 Safety notes (continued)
yment has been built and tested in accordance with the safety
nment for measurement, control, and laboratory use. To main
2. Safety
This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control, and laboratory use. To maintain this condition and
ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use.
ent has been built and tested in accordance with the safet
ent for measurement, control, and laboratory use. To mai
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.
Leica HistoCore SPECTRA ST
LASER RADIATION - DO NOT
STARE INTO BEAM
EN 60825-1: 2007
P<1 mW, O= 630 to 670 nm
Pulse duration = 500 μs
Class 1 laser product
15
2. Safety
tstrumen
2.2 Warnings
Warnings on the instrument
trumen
The safety devices installed in this instrument by the manufacturer only 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 Warnings (continued)
nsport and installation
2. Safety
Warnings - Transport and installation
port and installatio
The instrument must only be transported in an upright position.
The empty weight of the instrument is 185 kg; therefore, four qualified persons are re-
quired 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 posi-
tion.
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 be-
ing operated.
Reagent cuvettes must always be filled outside of the instrument in compliance with
the safety information.
Leica HistoCore SPECTRA ST
17
2. Safety
tng the instrume
2.2 Warnings (continued)
Warnings – Operating the instrument
ng the instrumen
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 m
an air exchange rate of 8 (25 m
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!
3/m2
h) in the lab.
3
/h and
18
Instructions for Use V 0.5 RevC - 08/2014
2.2 Warnings (continued)
)(continued)
2. Safety
Warnings – Operating the instrument (continued)
ating the instrument
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 tempera-
ture 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.
continued
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
2. Safety
erizontal plane (x and y-axis) for safety reasons to eliminate
.n with moving part
2.3 Safety features on the instrument
As soon as the hood of the instrument is opened, the movements of the transport arms are
stopped in a horizontal plane (x and y-axis) for safety reasons to eliminate specimen damage
due to collision with moving parts.
hood of the instrument is opened, the movements of the
rizontal plane (x and y-axis) for safety reasons to eliminat
with moving parts
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
3.1 Standard delivery—packing list
p
on
3. Instrument Components and Specifications
.
Instrument Com
Qty Designation Order No.
1 SPECTRA ST basic instrument 14 0512 47567
1 Power cable country-specific
46 Reagent cuvettes, assembly, including reagent cuvette cover 14 0512 47086
6 Water flow cuvettes, assembly 14 0512 47087
6 O-rings 7x2, for water flow cuvette connecting piece 14 0253 47088
Sanitation and water supply equipment accessories:
1
2
1 Pressure hose, 1.5 m extension 14 0512 49334
1 Y piece 14 3000 00351
2 Double nipple G3/4 G3/8 14 3000 00350
1 Water filter housing 14 0512 49331
1 Filter cartridge 14 0512 49332
1
1 Exhaust hose, 2 m 14 0475 35762
2 Active carbon filter 14 0512 47131
tion
ST basic instrument
Outlet hose, length: 2 m 14 0475 35747
Inflow hoses, Ø 10 mm, length: 2.5 m 14 0474 32325
Bushing G 3/4 14 3000 00360
3 Rack for 30 specimen slides (3 pcs. per package) 14 0512 52473
1 Clip for rack for 30 specimen slides (yellow, 3 pcs. per package) 14 0512 52576
1 Clip for rack for 30 specimen slides (dark blue, 3 pcs. per package) 14 0512 52478
1 Clip for rack for 30 specimen slides (red, 3 pcs. per package) 14 0512 52480
1 Clip for rack for 30 specimen slides (white, 3 pcs. per package) 14 0512 52484
1 Instructions for Use, printed (German/English, with
Language CD 14 0512 80200)
Leica HistoCore SPECTRA ST
14 0512 80001
21
3. Instrument Components and Specifications
s
ts and Specification
p
es:
000-240 AC
0/60
ts and Specification
3.2 Technical Data
Nominal supply voltages: 100-240 V AC +10 %
Nominal frequency: 50/60 Hz
Power draw: 1350 VA
Fuses: 2 x T16 A H 250 V AC
IEC 1010 classification: Protection class 1
Pollution degree: 2
Overvoltage category: II
Fresh water connection:
Hose material: PVC
Hose length:
Connecting piece: G3/8
Inner diameter: 10 mm
Outer diameter: 16 mm
Internal pressure: Minimum: 2 bar
Required flow rate:
Required water quality: Type 1, ISO 3696
ges:
Maximum: 6 bar
100-24
0/60
2500 mm
Min. 1,7 l/minute
10%
z
Waste water connection:
Hose length:
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 m
22
2000 mm/4000 mm
3
/h
Instructions for Use V 0.5 RevC - 08/2014
3.2 Technical data (continued)
p
hctive carbon filter and exh
uing with an external exhau
3. Instrument Components and Specifications
.
Instrument Com
Exhaust extraction: Active carbon filter and exhaust hose for connect-
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)
Ambient conditions:
Operation:
Temperature:
Relative humidity: 20 % to 80 %, non-condensing
Operating elevation: Up to a max. of 2000 m above sea level
Storage:
n: Active carbon filter and ex
ng with an external exha
ing with an external exhaust system
1 x RJ45 Ethernet (front): Only for service purposes
2 x USB 2.0:
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.
5 V/500 mA (service & data storage)
+18 °C to +30 °C
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):
Empty weight (without reagents and accessories): 185 kg
Leica HistoCore SPECTRA ST
Hood closed: 135.4 x 78.5 x 58.5 cm
Hood open: 135.4 x 78.5 x 94.3 cm
23
3. Instrument Components and Specifications
s
ts and Specification
p
ts and Specification
3.3 Overview
Front view
6
1
9
5
2
3
4
1 Insert for active carbon filter 6 Screen with user interface
2 Read-in area for Leica reagents 7a USB sockets (2 pcs.),
3 Input drawer 7b Service access
4 Output drawer 8 ON/OFF switch
5 Screen holder with interior lighting 9 Lid
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
7a/b
8
Fig. 2
3.3 Overview(continued)
p
Rear view
3. Instrument Components and Specifications
.
Instrument Com
1
2
1 Network connection (RemoteCare/LIS)
2 Power supply
3 Waste outlet
3
5
4
Fig. 3
4 Running water connections
5 Exhaust air connection
Leica HistoCore SPECTRA ST
25
3. Instrument Components and Specifications
s
ts and Specification
p
3.3 Overview(continued)
Inside view
ts and Specification
-
910
1
-
78
6
2345
1 Left transport arm 6 Transfer station for SPECTRA CV (optional)
2 Specimen slide reader module 7 Right transport arm
3
Load station, 5 pcs. 8 Rinsing water stations, 6 pcs.
4 Dry transfer stations, 2 pcs. 9 Heated reagent stations, 4 pcs. (optional)
5 Unload station, 5 pcs. 10 Drying oven stations, 6 pcs
26
Fig. 4
Instructions for Use V 0.5 RevC - 08/2014
4. Installation and Starting Up
n
nstallation and leveling are carried out as part of the instrum
. I
4.1 Installation site requirements
Installation and leveling are carried out as part of the instrument installation by per-
sonnel authorized by Leica only!
Use 4 qualified persons when lifting the device; grab under the frame at all corners
and lift evenly.
It must be ensured that there is a mostly vibration-free floor and sufficient clear space (ap-
prox. 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 tempera-
ture 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/m
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 connec-
tion 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.
2
, vibration-free
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
4. Installation and Starting Up
p
p
s the option of choosing between two connection variants.
device must be programmed to the connection variant used
ee
ng U
4.2 Running water connection
There is the option of choosing between two connection variants.
The device must be programmed to the connection variant used (see Chap. 6.5).
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.
28
Fig. 5
Instructions for Use V 0.5 RevC - 08/2014
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