Leica BIOSYSTEMS HistoCore PEARL User manual

HistoCore PEARL
Tissue Processor
Instructions for Use
English
Order No.: 14 0493 80101 - Revision D
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 1.3, Revision D - 08.2018

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HistoCore PEARL
The information, numerical data, notes and value judgments contained in this manual represent the
current state of scientific knowledge and state-of-the-art technology as we understand it following
thorough investigation in this field.
We are under no obligation to update the present manual periodically and on an ongoing basis
according to the latest technical developments, nor to provide our customers with additional copies,
updates etc. of this manual.
To the extent permitted in accordance with the national legal system as applicable in each individual
case, we shall not be held liable for erroneous statements, drawings, technical illustrations etc.
contained in this manual. In particular, no liability whatsoever is accepted for any financial loss or
consequential damage caused by or related to compliance with statements or other information in this
manual.
Statements, drawings, illustrations and other information regarding the contents or technical details of
the present Instructions for Use are not to be considered warranted characteristics of our products.
These are determined only by the contract provisions agreed between ourselves and our customers.
Leica reserves the right to change technical 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.
Warning
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Tel.: +49 - (0) 6224 - 143 0
Fax: +49 - (0) 6224 - 143 268
Web: www.LeicaBiosystems.com
Assembly contracted to Leica Microsystems Ltd. Shanghai

4Version 1.3, Revision D
Table of Contents
1. Important Information ................................................................................................................................ 7
1.1 Symbols used in the text and their meanings............................................................................................. 7
1.2 Instrument type.............................................................................................................................................. 10
1.3 Intended use................................................................................................................................................... 10
1.4 Qualification of personnel............................................................................................................................ 10
2. Safety .......................................................................................................................................................... 11
2.1 Safety notes.................................................................................................................................................... 11
2.2 Warnings......................................................................................................................................................... 12
2.2.1 Markings on the instrument itself............................................................................................................... 12
2.2.2 Transport and Installation............................................................................................................................ 12
2.2.3 Operating the instrument.............................................................................................................................. 13
2.2.4 Handling reagents ......................................................................................................................................... 14
2.2.5 Cleaning and maintenance .......................................................................................................................... 15
2.3 Safety features on the instrument .............................................................................................................. 15
2.3.1 Overpressure protection .............................................................................................................................. 15
2.3.2 Overcurrent protection................................................................................................................................. 15
2.3.3 Overheating protection ................................................................................................................................ 15
3. Instrument Components and Specifications........................................................................................ 16
3.1 Overview ........................................................................................................................................................ 16
3.2 Main features of the instrument.................................................................................................................. 17
3.3 Technical Data............................................................................................................................................... 18
3.4 Compatible reagents..................................................................................................................................... 20
3.5 Recommended reagent handling................................................................................................................ 21
3.5.1 Cycle for changing reagents........................................................................................................................ 21
4. Initial Operation ........................................................................................................................................ 23
4.1 Installation site requirements...................................................................................................................... 23
4.2 Standard delivery - packing list................................................................................................................... 23
4.3 Unpacking and installation........................................................................................................................... 24
4.4 Basic instrument/hardware......................................................................................................................... 28
4.4.1 Installing the Display..................................................................................................................................... 28
4.4.2 The retort......................................................................................................................................................... 29
4.4.3 Active carbon filter........................................................................................................................................ 30
4.4.4 External exhaust system............................................................................................................................... 31
4.4.5 Counter area................................................................................................................................................... 32
4.4.6 Cassette baskets ........................................................................................................................................... 32
4.4.7 The display...................................................................................................................................................... 33
4.4.8 The paraffin baths.......................................................................................................................................... 34
4.4.9 The paraffin drip tray..................................................................................................................................... 35

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HistoCore PEARL
Table of Contents
4.4.10 Reagent cabinet with reagent bottles........................................................................................................ 36
4.4.11 The bottom tray.............................................................................................................................................. 37
4.4.12 Adhesive labels for reagent bottles............................................................................................................ 38
4.5 Alarm functions.............................................................................................................................................. 38
4.6 Connecting the power supply...................................................................................................................... 39
4.7 Switching the instrument on........................................................................................................................ 40
4.8 Touchscreen functions................................................................................................................................. 42
4.9 Switching off the instrument........................................................................................................................ 45
4.10 Moving the instrument.................................................................................................................................. 46
5. Operation.................................................................................................................................................... 47
5.1 Access levels ................................................................................................................................................. 47
5.2 Setting up system .......................................................................................................................................... 48
5.2.1 Languages....................................................................................................................................................... 48
5.2.2 Regional Settings .......................................................................................................................................... 48
5.2.3 Date/Time........................................................................................................................................................ 50
5.2.4 Alarm................................................................................................................................................................ 51
5.2.5 Installation ...................................................................................................................................................... 52
5.2.6 System Setup.................................................................................................................................................. 53
5.2.7 Data management ......................................................................................................................................... 54
5.2.8 Maintenance .................................................................................................................................................. 56
5.2.9 Event view....................................................................................................................................................... 58
5.2.10 Network........................................................................................................................................................... 58
5.3 Reagents ......................................................................................................................................................... 59
5.3.1 Reagent status ............................................................................................................................................... 59
5.3.2 Groups ............................................................................................................................................................. 60
5.3.3 Stations............................................................................................................................................................ 61
5.3.4 RMS.................................................................................................................................................................. 62
5.4 Program........................................................................................................................................................... 66
5.4.1 Adding/Editing programs.............................................................................................................................. 67
5.4.2 Favorite programs.......................................................................................................................................... 72
5.5 Dashboard....................................................................................................................................................... 73
5.6 Reagent handling........................................................................................................................................... 76
5.6.1 Filling/draining reagents............................................................................................................................... 76
5.6.2 Filling/refilling paraffin.................................................................................................................................. 77
5.7 Starting a program......................................................................................................................................... 79
5.8 Ending a program........................................................................................................................................... 84
5.9 Pre-installed program................................................................................................................................... 84
6. Cleaning and maintenance..................................................................................................................... 87

6Version 1.3, Revision D
Table of Contents
6.1 Cleaning program .......................................................................................................................................... 87
6.2 General instrument cleaning ....................................................................................................................... 88
6.2.1 Daily cleaning and maintenance................................................................................................................. 88
6.2.2 Weekly cleaning and maintenance............................................................................................................ 90
6.2.3 Monthly cleaning and maintenance........................................................................................................... 91
6.2.4 Recommended cleaning reagents.............................................................................................................. 92
6.3 Checklist for regular maintenance ............................................................................................................. 92
7. Troubleshooting ........................................................................................................................................ 94
7.1 Troubleshooting............................................................................................................................................. 94
7.2 Power failures................................................................................................................................................ 94
7.3 Malfunctions in the program sequence..................................................................................................... 95
7.3.1 Safe reagent................................................................................................................................................... 95
7.3.2 Crash or freeze of master software............................................................................................................ 96
7.4 Replacing a fuse ............................................................................................................................................ 96
8. Ordering information................................................................................................................................ 97
9. Warranty and Service ............................................................................................................................100
9.1 Warranty ....................................................................................................................................................... 100
9.2 Service information..................................................................................................................................... 100
9.3 Decommissioning and disposal................................................................................................................. 100
10. Decontamination Confirmation............................................................................................................101

7
HistoCore PEARL
Important Information 1
1. Important Information
1.1 Symbols used in the text and their meanings
Danger:
Indicates an imminently hazardous situation which, if not avoided, will result in death
or serious injuries.
Warning:
If this danger is not avoided, then this may result in death or serious injury.
Caution:
Indicates an potentially hazardous situation which, if not avoided, could result in death
or serious injury.
Note:
Indicates information which are important but not related to any risk.
Item numbers for numbering illustrations.
→"Fig. 7 - 1"Numbers in red refer to item numbers in illustrations.
Save Software symbols that have to be pressed on the input screen are displayed as bold,
gray text.
Manufacturer
Order number
Serial number
Manufacturer date
Observe the Instructions for Use
Caution, consult the instructions for use for cautionary information.
Caution, consult the instructions for use for cautionary information.
In vitro diagnostics (IVD) medical device
This product fulfills the requirements of the EU directives.
1

8Version 1.3, Revision D
Important Information
1
Symbol for labeling electrical and electronic equipment in accordance with Section
7 of the German Electrical and Electronic Equipment Act (ElektroG). ElektroG is the
law regarding the sale, return and environmentally sound disposal of electrical and
electronic equipment.
Environmental protection symbol of the China RoHS directive. The number in the
symbol indicates the "Environment-friendly Use Period" of the product. The symbol is
used if a substance restricted in China is used in excess of the maximum permitted
limit.
Symbol for alternating current
PE terminal
Power on
Power off
This warning symbol indicates the surfaces on the instrument that are hot during
operation.
Avoid direct contact to prevent risk of burning.
Biohazard warning
Solvents and reagents that are inflammable are marked with this symbol.
IPPC symbol
• Country code in accordance with ISO 3166, e.g. DE for Germany
• Regional identifier, e.g. HE for Hessen
• Producer/treatment provider code, unique assigned number starting with 49
• Treatment code, e.g. HT (heat treatment), MB (methyl bromide), and possibly DB
(debarked).
The package contents are fragile and must be handled with care.
The package must be kept in a dry environment.
Do not stack.

9
HistoCore PEARL
Important Information 1
Maximum of 3 stacked layers (only for the accessory box).
Indicates the correct upright position of the package.
Indicates the temperature range permitted for transporting the package.
Minimum -29 °C
Maximum +50 °C
Indicates the temperature range permitted for storing the package.
Minimum +5 °C
Maximum +50 °C
Indicates the humidity range permitted for storing and transporting the package.
minimum 10 % r.H.
maximum 85 % r.H.
In the Shockwatch system, the shock dot shows impacts or shocks that are above a
specified intensity through red colouration. Exceeding a defined acceleration (g value)
causes the indicator tube to change colour.
Tip-n-Tell indicator to monitor whether the shipment has been transported and stored
in upright position according to your requirements. With a pitch of 60° or more, the
blue quartz sand flows into the arrow-shaped indicator window and sticks there
permanently. Improper handling of the shipment is immediately detectable and can be
proven definitively.
This product fulfills the requirements of the CAN/CSA-C22.2 No. 61010.
Indicates the item can be recycled where correct facilities exist.

10 Version 1.3, Revision D
Important Information
1
1.2 Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on
the cover page.
A nameplate indicating the instrument serial number is attached to the rear side of the instrument.
1.3 Intended use
The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax
infiltration. It is normally processed in sequential mode, which means that the instrument is strictly
using one bottle after the other.
The HistoCore PEARL is a tissue processor for the following laboratory applications:
• Fixation
• Dehydration
• Infiltration with intermedium
• Paraffin infiltration
of histological tissue specimens.
The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible
reagents (→P. 20 – 3.4 Compatible reagents).
Caution
Any other use of the instrument is considered Off Label use.
Failure to observe these instructions may result in an accident, personal injury, damage to the
instrument, accessories or specimens.
Proper and intended use includes compliance with all inspection and maintenance instructions,
along with the observance of all instructions in the Instructions for Use.
1.4 Qualification of personnel
• The HistoCore PEARL must be operated by trained laboratory personnel only.
• All laboratory personnel designated to operate this instrument must read these Instructions for Use
carefully and must be familiar with all technical features of the instrument before attempting to
operate it.

11
HistoCore PEARL
Safety 2
2. Safety
2.1 Safety notes
The Instructions for Use includes important information related to the operating safety and maintenance
of the instrument.
The Instructions for Use is an important part of the product, and must be read carefully prior to startup
and use and must always be kept near the instrument.
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 the Instructions for Use.
Caution
• All information messages displayed on the touchscreen must be read and observed at all times.
• The safety and caution notes in this chapter must be observed at all times.
• Be sure to read these notes even if you are already familiar with the operation and use of other
Leica Biosystems products.
• The protective devices located on the instrument and the accessories must not be removed
or modified. Only qualified service personnel authorized by Leica Biosystems may repair the
instrument and access its internal components.
• 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 other property. The instrument must be used only as intended
and only if all of its safety features are in proper working condition. Malfunctions which could
impede safety must be remedied immediately.
• Only original spare parts and permitted original accessories can be used.
• If the instrument is to be returned to Leica Biosystems for repair, it must be cleaned
and decontaminated in the appropriate manner. For details, please see (→P. 101 – 10.
Decontamination Confirmation).
Note
The Instructions for Use must be appropriately supplemented as required by the existing regulations
on accident prevention and environmental safety in the operator‘s country.
Note
The instrument complies with the emission and immunity requirements described in the IEC
61326-2-6.
Note
For current information about applicable standards, please refer to the CE declaration for the
instrument and to our Internet site:
http://www.LeicaBiosystems.com

12 Version 1.3, Revision D
Safety
2
2.2 Warnings
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, be sure to comply with the following instructions
and warnings.
2.2.1 Markings on the instrument itself
Caution
Markings on the instrument showing the warning triangle indicate that the correct operating
instructions (as defined in the Instructions for Use) must be followed when operating or replacing
the item marked. Failure to observe to these instructions may result in an accident, personal injury,
damage to the instrument, accessories or specimens.
Caution
Some instrument surfaces become hot during operation. They are marked with this warning label.
Touching these surfaces may cause burns.
2.2.2 Transport and Installation
Caution
• Once unpacked, the instrument must be transported only in an upright position.
• Follow the unpacking instructions carefully to avoid damage to the instrument!
• Prior to every transport in which it is possible for the instrument to be shaken, tilted, or lifted, it
must be cleaned including the tubing, paraffin baths and reagent bottles – otherwise the interior
of the instrument can be severely damaged.
• Plug the instrument only into a grounded power socket. Make sure an obligatory use of a CB
(Circuit breaker).
• Severe damage may occur if the instrument is connected to a power supply voltage other than
that to which it shows on the nameplate.
• The installation location must be well-ventilated; there should be no ignition sources there of any
kind. The chemicals to be used in the HistoCore PEARL are both flammable and noxious.
• Do not operate the instrument in rooms with explosion hazard.
• Extreme temperature fluctuations between storage facility and setup site as well as high humidity
may cause condensation to form. If this is the case, wait at least two hours before switching on
the instrument. Failure to comply with this may cause damage to the instrument.

13
HistoCore PEARL
Safety 2
2.2.3 Operating the instrument
Caution
• The instrument can only be operated by trained laboratory personnel. It must only be operated for
the purpose of its designated use and according to the instructions contained in the Instructions
for Use.
• Failure to observe the instructions specified by the manufacturer may result in damage to the
protection provided by the instrument.
• Pre-installed Leica Biosystems programs are validated based on Leica Biosystems consumables
and reagents.
• Before using the instrument, run the Bottle Check function to check the connections of the
reagent bottles. Make sure that they are properly connected. Prevent any leaks or blockages.
• Before opening the retort when a program is in progress, always press the pause button so that
the retort is ventilated or vented.
• After refilling/replacing reagent bottles, make sure the reagent bottles caps are closed tightly.
• The reagent bottles must be properly pushed home into the connection manifolds at the rear inner
wall of the reagent module.
• Failure to plug the reagent bottles into the manifold correctly will interrupt the program process
and may also result in spilling of reagents.
• Fixing solutions that contain mercury salts, acetic acid, or picric acid can cause corrosion on
metal components.
• When there is a potential exposure to the infective material and/or toxic vapor, please wear
chemical protective clothing, protective goggles, respirator, rubber gloves and all other necessary
personal protective equipment.
Caution
In exceptional situations (e.g. accidental reagent spills), it may be necessary to wear a respirator.
This depends on the specific local ambient temperature, room volume, additional load, ventilation
rate etc. In case of doubt, the laboratory owner/operator must carry out a local measurement
to prove that applicable maximum workplace concentrations are not exceeded. Measurements
performed of maximum workplace concentrations that occur at an air change rate of 8 times per
hour and a room temperature of 40 °C, room volume of 18 m3and reagent temperature of 45 °C have
shown that limit values are exceeded for short periods during the step when specimens are loaded
in formalin. At lower ambient temperatures and/or larger room volumes in the laboratory or higher
ventilation rates, the workplace concentration will be less. The exact concentration values can only
be measured locally. The limits were complied with in all operating states.
Caution
The electromagnetic environment should be evaluated prior to operation of the instrument. Do not
use this instrument in close proximity to sources of strong electromagnetic radiation (e.g. unshielded
intentional RF sources), as these can interfere with the proper operation.
Note
Material safety data sheets can be obtained from the supplier of the chemicals.
If using Leica branded reagents, MSDS are available on-line at
http://www.LeicaBiosystems.com

14 Version 1.3, Revision D
Safety
2
2.2.4 Handling reagents
Caution
• To prevent damage to the instrument, use only the reagents listed in Chapter 3.4 (→P. 20 – 3.4
Compatible reagents)!
• Do not use acetone, benzene, chloroform and trichlorethane on HistoCore PEARL.
• 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.
• Do not clean reagent bottles in a dishwasher; the reagent bottles are NOT dishwasher-proof.
Caution
• Reagents used for tissue processing can be both toxic and/or flammable. Take care when
handling reagents! Always wear chemical protective clothing, protective goggles, respirator,
rubber gloves and all other necessary personal protective equipment.
• Keep the instrument away from fire and heat.
Caution
Use caution when handling paraffin or removing the specimens/baskets from the retort – molten
paraffin is hot and may cause burns. Also, avoid personal contact with paraffin baths and retort walls
– they can be hot as well.
Caution
• When handling fixation, dehydration or clearing reagents (e.g. Formalin, ethanol, xylene, etc.),
wear Personal Protective Equipment (lab coat, protective goggles, respirator, rubber gloves, etc.).
• When handling infiltration reagents (e.g. paraffin, etc.), wear Personal Protective Equipment (lab
coat, protective goggles, respirator, safety gloves, etc.).
Caution
• For toxic reagents, such as fixation reagents (e.g. Formalin), clearing reagents (e.g. xylene), store
them in a cool, ventilated warehouse/safe cabinet, and keep them away from fire and heat. When
handling the toxic reagents, wear personal protective equipment (lab coat, protective goggles,
respirator, rubber gloves, etc.).
• For flammable reagents, such as dehydration reagent (e.g. absolute ethanol, diluted ethanol,
etc.), infiltration reagents (e.g. paraffin), store them in a cool, ventilated warehouse/safe cabinet,
and keep them away from fire and heat. When handling the flammable reagents, wear personal
protective equipment (lab coat, protective goggles, respirator, rubber gloves/safety gloves, etc.).

15
HistoCore PEARL
Safety 2
2.2.5 Cleaning and maintenance
Caution
• Do not clean the instrument with solvents containing acetone or xylene. No liquid may be spilled
into the internal components of the instrument – neither during operation nor during cleaning.
• When using cleaners, please comply with the safety instructions of the manufacturer and the
laboratory safety regulations.
• Check the condensate bottle at least once a week and empty it.
• If the instrument is not to be used for a long time, drain out the reagent and paraffin. Use deionized
water to clean the formalin bottle and water bottle, and dry; use ethanol to clean the ethanol
bottle, xylene bottle and paraffin baths, and dry; use ethanol to wipe clean the instrument exterior.
2.3 Safety features on the instrument
The HistoCore PEARL tissue processor is equipped with safety functions and with sophisticated
software control mechanisms. These ensure that the specimens remain undamaged in the event of a
power failure or other malfunction during the program and that the program is completed successfully.
2.3.1 Overpressure protection
• When the power is switched off, the pressure air pump and valves default to a safe condition (retort
vented, no pressure generation).
• In addition, there is a relief valve that vents all excess air pump output to atmosphere.
2.3.2 Overcurrent protection
Overcurrent conditions are protected against by the main fuse overcurrent protection.
2.3.3 Overheating protection
The heat limiter protects the instrument against the abnormally high temperature.

16 Version 1.3, Revision D
Instrument Components and Specifications
3
3. Instrument Components and Specifications
3.1 Overview
Instrument components
Fig. 1
1
9
5
13
3
11
7
15
2
10
6
14
4
12
8
16
1Active carbon filter 9Caster
2Specimen baskets 10 Condensate bottle (1)
3Retort 11 Paraffin drip tray
4Lid latch knob 12 Paraffin oven
5Paraffin baths (3) 13 Basic instrument
6Paraffin oven cover 14 Counter area
7Reagent bottles (13) 15 Display
8Bottom tray 16 Retort lid

17
HistoCore PEARL
Instrument Components and Specifications 3
Rear panel
Fig. 2
1
9
5
3
7
2
10
6
4
8
1
1Handles for moving the instrument (2) 6USB ports (2)
2Remote alarm connection 7Main power switch (ON/OFF)
3Network connection 1 (LAN 1) for service 8Power supply input
4Local alarm connection 9Fuses
5Network connection 2 (LAN 2) for
RemoteCare
10 Exhaust interface
Note
The USB ports are for memory sticks only. Do not connect any other type of USB device to the
instrument.
3.2 Main features of the instrument
• The HistoCore PEARL is equipped with an LCD touch screen. Multilingual user interface and graphic
display of the program flow (dashboard) are for clarifying all menu steps.
• The HistoCore PEARL can be operated using customized or pre-installed, validated tissue processing
programs. There are 3 pre-installed, non-editable programs available, including 1 Cleaning program, 1
Overnight and 1 Biopsy.
• 10 processing programs are freely configurable with up to 14 steps (temperature; time; reagent;
pressure/vacuum options).
• Reagent Management System (RMS) enables the users to monitor the usage of reagents per number
of cassettes, cycles or days.
• The quick start system enables the users to start each program immediately from the Favorite
program panel (max. 5 programs).
• The number of cassettes, number of processing cycles, days since the last change and the reagents
to be replaced can be displayed according to the customized settings of the RMS.

18 Version 1.3, Revision D
Instrument Components and Specifications
3
• Three paraffin baths are used for the tissue infiltration, each with a max. capacity of 3.5 L of liquid
paraffin. The paraffin baths can be easily removed for cleaning simply by pulling them out. The
paraffin drip tray is used to collect any spilled paraffin.
• Harmful reagent vapors are continuously suctioned back from the retort into the instrument and
filtered even after the retort is opened, e.g. to reload cassettes or baskets. The instrument uses an
active carbon filter. In addition, it is recommended to connect the instrument to an external vacuum
extractor via a separate port on the rear of the instrument.
• The retort is capable of holding up to 200 standard cassettes depending on whether it is operated
with one or two baskets.
• RemoteCare Internet connection between the instrument and the Service Support Team enables
optimized service through monitoring of the instrument and its functions.
• The user can transfer all processing programs and logs via USB.
• Access to the instrument can be limited via a multilevel password protection system.
• The user can utilize the Bottle Check function to ensure connecting status of reagent bottles.
• In the event of a power failure, the alarm system is triggered off. The HistoCore PEARL will provide
recovery measures after interruption.
• In the event of an error, an alarm is sound immediately. The system will retry first to recover, if this
is unsuccessful the instrument will then fill the retort with a safe reagent to ensure the safety of
specimens if no operation is taken on the display in 15 minutes.
• Three alarm modes: instrument alarm, local alarm and remote alarm, enable the customers to be
alerted whenever necessary.
3.3 Technical Data
General
Nominal supply voltages 100 to 120 V AC or
220 to 240 V AC
Nominal frequency 50/60 Hz
Main Fuses 2 melting fuses, 32 x 6.3 mm, UL-approved
T15 A 250 VAC
Nominal power 1650 VA
Operating temperature range +10 °C to +35 °C
Transport temperature range -29 °C to +50 °C
Storage temperature range +5 °C to +50 °C
Transport and storage relative humidity 10 % to max. 85 % non-condensing
IEC 61010 classification Pollution degree 2
Overvoltage installation category II
Operating elevation Up to a max. of 2000 m above sea level
A-weighted noise level < 70 dB (A)
Local/remote alarm relay 30 V DC, maximum 1 A
Air-liquid system pressure range -40 kPa to +40 kPa
Dimensions and weights
Dimensions, unpacked (W x D x H), in mm 600 x 710 x 1320
Empty weight, unpacked Max. 140 kg

19
HistoCore PEARL
Instrument Components and Specifications 3
Dimensions and weights
Weight, packed Max. 175 kg
Paraffin baths
Number of paraffin baths 3
Capacity Max. 3.5 L per paraffin bath
Support paraffin melting point 50 °C - 64 °C
Melting time 50 °C - 64 °C, 12 hours
Temperature settings range 50 °C - 70 °C
Retort
Capacity Max. 200 cassettes
Temperature (paraffin) 50 °C - 70 °C
Temperature (processing reagents) Ambient temperature or 35 °C to 60 °C
Temperature (cleaning reagents) Ethanol 62 °C, Xylene 67 °C
Reagent bottles
Reagent bottles 11 (in reagent cabinet)
Condensate bottle 1
Cleaning bottles 2
Bottle volume Max. 3.5 L
Reagent Management System (RMS)
RMS • Processing program: Cassettes/Cycles/Days
• Cleaning program: Cycles/Days
Access levels
Access levels • Standard User
• Supervisor
• Service
Password status • Supervisor
• Service
Type of password Alphanumeric, freely selectable
Hardware and Software
• Color LCD touchscreen.
• User-friendly, interactive software.
• Two USB 2.0 ports, DC 5V.
• Alarm system with two alarm sockets (for local alarm and remote alarm).
• Smart error-handling for specimen protection.

20 Version 1.3, Revision D
Instrument Components and Specifications
3
Capacities
• 10 freely configurable programs and 2 pre-installed programs, each consisting of up to 11 reagent
and 3 paraffin processing steps.
- Time per program step: 0 to 99 hours, 59 minutes.
- Delay time: max. 7 days.
• Up to 200 cassettes can be processed simultaneously.
• 1 cleaning program for the retort.
• 11 reagent bottles.
• 2 cleaning bottles.
• 1 condensate bottle.
• 3 paraffin baths.
• Reagent temperature selectable from 35 °C to 60 °C or ambient temperature, depending on the
reagent.
• Paraffin temperature selectable from 50 °C to 70 °C.
• Cleaning temperature of 62 °C (ethanol) or 67 °C (xylene).
3.4 Compatible reagents
Caution
Use of the HistoCore PEARL is permitted with the reagents specified in this section only. These
reagents must be validated before use, i.e. tissue processing with patient tissue for diagnostics, by
the laboratory itself according to the local or regional accreditation requirements.
Reagents other than these listed here may cause severe damage to the components of the
instrument.
Acetone, benzene, chloroform and trichlorethane must NOT be used.
The following reagents may be used in the HistoCore PEARL:
Fixatives Dehydration Clearing Xylene Replacement
1. Formalin 1. Ethanol 1. Xylene 1. Surgipath
(buffered or 2. Isopropanol 2. Toluene* Sub-x
unbuffered) 3. Methanol- 2. Sakura Tissue Tek
Isopropanol mixture Tissue Clear
(50% Methanol) 3. Thermo Scientific
Shandon Xylene
Substitute
* Before using these reagents, please obtain information from Leica Biosystems or the supplier about
required preventive measures.