XL (ST5010) Instructions for Use ver 3.1 Rev M June 2021

Note The information, numerical data, notes and value judgments contained in this Instructions for Use 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 Instructions for Use periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of this Instructions for Use. To the extent permitted in accordance with the national legal system as applicable in each individual case, we shall not be held liable for erroneous statements, drawings, technical illustrations etc. contained in this Instructions for Use. In particular, no liability whatsoever is accepted for any financial loss or consequential damage caused by or related to compliance with statements or other information in this Instructions for Use. Statements, drawings, illustrations and other information regarding the contents or technical details of the present Instructions for Use are not to be considered warranted characteristics of our products. These are determined only by the contract provisions agreed between ourselves and our customers. Leica reserves the right to change technical 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 Strasse 17 - 19 69226 Nussloch Germany Tel.: +49 - (0) 6224 - 143 0 Fax: +49 - (0) 6224 - 143 268 Web: www.LeicaBiosystems.com

Leica Autostainer XL (ST5010)

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Table of contents 1.

Important Information...6 1.1 1.2 1.3 1.4

2.

Safety... 12 2.1 2.2

3.

5.

General safety notes...12 Specific safety notes...13

Instrument Features... 15 3.1 3.2 3.3

4.

Symbols in the text and their meaning... 6 Instrument type...10 Intended purpose...10 User group...11

General description...15 Standard delivery – packing list...18 Technical Data...19

Installing the Instrument... 21 4.1 Installation site requirements...21 4.2 Setting up the instrument...22 4.3 Connections on the instrument...22 4.3.1 Power supply...22 4.3.2 Water supply...23 4.4 Battery backup – UPS (optional)...23 4.5 Remote alarm (optional)...24 4.6 Vacuum extraction system for reagent vapors...25 4.7 Oven...25

Operating the Instrument... 26

5.1 The control panel...26 5.2 Main menu...27 5.3 Menu overview...28 5.4 Editing programs...29 5.4.1 Entering program steps...29 5.4.2 Deleting program steps...30 5.4.3 Inserting a blank step into a program...30 5.4.4 Removing blank steps from a program...31 5.4.5 Saving a program...31 5.4.6 Deleting a program...31 5.4.7 Copying a program...31 5.4.8 Viewing a program...32 5.4.9 Checking the compatibility of programs...32 5.5 User-adjustable parameters...33 5.6 Oven...33 5.7 Up/down movement (dips)...34 5.8 Number of up/down movement (dips)...34

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Table of contents 5.9 Staining...35 5.9.1 Reagent vessels...35 5.9.2 Wash system...35 5.9.3 Water-saving function...36 5.9.4 Loading specimen slide holders...36 5.9.5 Unloading specimen slide holders from the exit drawer...36 5.9.6 Unloading specimen slide holders from other stations...37 5.9.7 Interrupting staining...37 5.9.8 Aborting the processing of a specimen slide holder...38 5.9.9 Operation as a workstation...38

6.

Care and Cleaning... 39 6.1 6.2 6.3 6.4 6.5 6.6

7.

Wash vessels...39 Reagent vessels...40 Specimen slide holders...40 Oven...40 Water drainage...40 Changing the active carbon filter...41

Error Messages and Troubleshooting... 43 7.1 Warning messages for instrument errors...43 7.2 More information and warnings...44 7.2.1 During staining...44 7.2.2 During editing of programs...44 7.2.3 During SetUp...44

8.

Warranty and Service... 45

9.

Decommissioning and disposal... 46

10.

Decontamination Confirmation... 47

11.

Appendix... 48 11.1 11.2 11.3 11.4

Adjustable parameters...48 Consumables and accessories...48 Compatible staining programs...50 Glossary...52

Leica Autostainer XL (ST5010)

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1 Important Information 1.

Important Information General information 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. They must be read carefully prior to startup and use, and must always be kept near the instrument. If additional requirements for accident prevention and environmental protection apply in the country of operation, these Instructions for Use must be supplemented by appropriate instructions to ensure compliance with such requirements. Make sure to read all of these Instructions for Use before you work on or operate the instrument. Warning Be sure to comply with the safety instructions and warnings in (→ p. 12 – 2. Safety). Be sure to read these notes even if you are already familiar with the operation and use of other Leica products.

1.1

Symbols in the text and their meaning

Symbol:

Title of the symbol: Description:

Warning Warnings appear in a white box and are marked by a warning triangle.

Symbol:

Title of the symbol: Description:

Note Useful tips, i.e. important information for the user, appear in white boxes and are marked by an information symbol.

Symbol: → "Fig. 7 - 1"

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Item number Numbers in parentheses refer to item numbers in illustrations or to the illustrations themselves. In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

Symbol:

Title of the symbol: Description:

Consult Instructions for Use Indicates the need for the user to consult the Instructions for Use.

Symbol:

Title of the symbol: Description:

China ROHS Environmental protection symbol of the China ROHS directive. The number in the symbol indicates the "Environment-friendly Use Period" of the product in years.

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Important Information Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbols:

Title of the symbol: Description:

1

WEEE Symbol The WEEE (Waste Electrical and Electronic Equipment) symbol, indicating separate collection of electrical and electronic equipment, consists of a crossed‑out wheeled bin (§ 7 ElektroG). CE Label The CE marking is the manufacturer's declaration that the medical product meets the requirements of the applicable EC directives and regulations. UKCA Label The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking. Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. Caution – Moving parts Label is attached on the transport arm. It indicates a risk of collision between the transport arm and any operator working within the instrument while the transport arm is moving. Caution – Toxic chemicals / Flamable substances Labels are attached inside the instrument below the fixation of the hood (in the middle). The first label indicates that toxic chemicals are inside the instrument. Do not handle solution vessels unless properly protected.

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Leica Autostainer XL (ST5010)

The second label indicates that there is a risk of fire because of flamable substances inside the instrument. Thus, avoid any source of ignition close to the instrument. Caution – Hot surface Two labels are attached close to the oven. They indicate a risk of burns because of hot surfaces. Do not touch these parts. Caution – Risk of fire Label is attached at the rear of the instrument close to the fuse. It indicates a risk of fire in case that no or inappropriate fuses are used. For continued protection against the risk of fire replace only with appropriate fuses as indicated on the instrument.

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1 Important Information Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Serial number Indicates the manufacturer's serial number so that a specific medical device can be identified.

Symbol:

Title of the symbol: Description:

Article number Indicates the manufacturer's catalog number so that the medical device can be identified.

Symbol:

Title of the symbol:

Alternating current

Symbol:

Title of the symbol: Description:

Manufacturing date Indicates the date when the medical device was manufactured.

Symbol:

Title of the symbol: Description:

Manufacturer Indicates the manufacturer of the medical product.

Symbol:

Title of the symbol: Description:

This way up Indicates correct upright position of the transport package.

Symbol:

Title of the symbol: Description:

Store dry Indicates a medical device that needs to be protected from moisture.

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Caution – Input voltage Label is attached at the rear of the instrument above the switched mains power inlet. It indicates that the unit is wired either for 100‑120 VAC or 230‑240 VAC (depending on your order). Do not change wiring or voltage selection on your own but contact qualified Leica service personnel in this case. Caution – Water supply and interfaces Labels are attached at the rear of the instrument close to the serial port and the water supply connections. They indicate that both Instructions for Use and – if applicable – any inscription on the instrument must be observed. CSA Statement (Canada/USA) The CSA test mark means that a product has been tested and fulfills the applicable safety standards.

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Important Information

1

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Symbol:

Title of the symbol: Description:

Stack limit The largest number of identical packages allowed to be stacked; "2" stands for the number of permitted packages.

Symbol:

Title of the symbol: Description:

Temperature limit for transport Indicates the transport temperature limits to which the medical device can be safely exposed.

Symbol:

Title of the symbol: Description:

Temperature limit for storage Indicates the storage temperature limits to which the medical device can be safely exposed.

Symbol:

Title of the symbol: Description:

Humidity limitation for transport and storage Indicates the range of humidity for transport and storage to which the medical device can be safely exposed.

Symbol:

Title of the symbol: Description:

Tilt indicator 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.

Leica Autostainer XL (ST5010)

Country of Origin The Country of Origin box defines the country where the final character transformation of the product has been performed. Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully.

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1 Important Information Symbol:

Symbol:

Title of the symbol: Description:

Title of the symbol: Description:

IPPC symbol The IPPC symbol includes IPPC symbol • Country code to ISO 3166, e.g. DE for Germany • Regional identifier, e.g. NW for North Rhine-Westphalia • Registration number, unique number beginning with 49. • Treatment method, e.g. HT (heat treatment) ON / STOP (Power) ON: The electronic power supply is connected upon pushing the power switch. STOP: The electronic power supply is disconnected upon pushing the power switch. Label is attached close to the electronic power supply switch.

1.2

Instrument type All information given in these Instructions for Use applies only to the instrument type indicated on the title page. A nameplate indicating the instrument serial number is attached to the rear side of the instrument. Precise data for the various versions is specified in (→ p. 19 – 3.3 Technical Data).

1.3

Intended purpose The Leica Autostainer XL (ST5010) is an automated stainer specifically designed for staining of human tissue specimens in order to contrast cell formations and their components used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The Leica Autostainer XL (ST5010) is designed for in vitro diagnostic applications. Warning Any use of the instrument that deviates from the intended purpose 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 purpose 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 Leica Autostainer XL (ST5010) carries out the specified staining steps automatically. The manufacturer assumes no liability for the staining results in the case that the staining steps and programs are entered incorrectly. Thus, the end user is independently responsible for self-created reagents or program entries.

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Important Information 1.4

1

User group • The Leica Autostainer XL (ST5010) should be operated by trained laboratory personnel only. • All laboratory personnel designated to operate the Leica Autostainer XL (ST5010) must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate the Leica Autostainer XL (ST5010). The instrument is intended for professional use only. Note To prevent damage to the instrument and specimens, only those accessories and spare parts that have been authorized by Leica may be installed or used with the instrument.

Leica Autostainer XL (ST5010)

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2 Safety 2.

Safety

2.1

General safety notes Warning • 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 instruments. • The protective devices located on the instrument and the accessories must not be removed or modified. • Only qualified service personnel authorized by Leica may repair the instrument and access its internal components. Residual risks: • This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control and laboratory use. Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or death or can cause damage to the instrument or property. • The instrument may be used only as intended and only if all of its safety features are in proper working condition. • To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use. • If malfunctions occur that can impede safety, the instrument must be put out of operation immediately and the responsible Leica service technician must be notified. • Only original spare parts and permitted original Leica accessories may be used. • In accordance with national rules and regulations, the operator may be obligated to provide longterm protection of the public water supply from contamination due to backflowing water from the building installation. In Europe, the protection device of the potable water installation to be connected is selected in accordance with the specifications of DIN EN 1717:2011-08 (information status August 2013). For current information about applicable standards, please refer to the CE Declaration of Conformity and UKCA Declaration of Conformity on our Internet site: www.LeicaBiosystems.com Warnings – Handling reagents Warning • Exercise caution 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. In addition, we highly recommend connecting the instrument to an external exhaust air extraction system. The chemicals to be used in the Leica Autostainer XL (ST5010) are flammable and hazardous to health. • Do not operate the instrument in rooms with an explosion hazard. • Use only reagents and cosumables which are within their expiration date. • When disposing of spent reagents, observe the applicable local regulations and the waste disposal regulations of the company/institution in which the instrument is being operated. • Reagent vessels must always be filled outside of the instrument in compliance with the safety information.

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Safety 2.2

2

Specific safety notes Warning Operating the instrument without adequate clothing Personal injury • Always wear protective clothing suitable for laboratory use, as well as rubber gloves and safety goggles when handling the chemicals used in this instrument. • Always follow your laboratory safety regulations. Warning Breathing in vapors dangerous to health Personal injury • Connect the instrument to a laboratory air exhaust system using the dedicated hose (lenghts of 2 m and 4 m available). Alternatively the instrument can be operated below a fume cupboard. This should be run in addition to the active carbon filter. Warning Contamination after accidential handling of reagents Insufficient staining quality or complete loss of tissue • If you have accidentially contaminated reagents, e.g., because a reagent has dripped into another vessel always follow your local regulations. Focus on saving the tissue first. Dispose any contaminated reagents and clean the affected vessels thoroughly. Warning Vessels not cleaned or cleaned insufficiently before refilling with another reagent Insufficient staining quality, tissue damage or loss of tissue • Always clean the vessels thoroughly and regularly before refilling them (→ p. 40 – 6.2 Reagent vessels). Caution

Inadequate manual loading of specimen slide holders into vessels Loss of tissue and / or property damage because of crash due to automized loading of another specimen slide holder into the same vessel • Do not manually load specimen slide holders and start any movement of the transport arm Caution

Lids not removed from vessel Loss of tissue and / or property damage because of crash due to automized loading of a specimen slide holder • Always make sure that any lids are removed before initiating any transport to the affected vessel.

Leica Autostainer XL (ST5010)

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2 Safety Caution

Specimen slide holders are loaded unintentionally into exit drawer instead of the load drawer. Delay of processing time / Damage or loss of tissue • Always pay attention to load specimen slide holders into the load drawer (→ p. 36 – 5.9.4 Loading specimen slide holders). Caution

Reagent filling level within vessels is insufficient Loss of tissue and / or property damage because of crash due to automized loading of a specimen slide holder • Check the filling level of the vessels regularly and clean and / or refill if required. • Cover unused vessels to minimize evaporation. Caution

Water drainage not cleaned or cleaned insufficiently Insufficient staining quality, loss of tissue or property damage • Check and clean the draining system regularly for correct flow. Caution

Specimen slide holders not unloaded in a timely manner from exit drawer Delay of processing time / Damage or loss of tissue • Unload the exit drawer in time, close the exit drawer and press EXIT (→ p. 36 – 5.9.5 Unloading specimen slide holders from the exit drawer). Caution

Specimen slide holder processed with wrong program parameters Damage or loss of tissue • Always double‑check program parameters of user‑specific programs before you start processing.

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Instrument Features 3.

Instrument Features

3.1

General description

3

The Leica Autostainer XL (ST5010) was developed with the goal of satisfying the quality requirements of modern laboratories: • high specimen throughput, • flexibility, • safety. The Leica Autostainer XL (ST5010) achieves its high throughput by means of a specimen slide transport system, which allows for simultaneous processing of up to 11 specimen slide holders, each with 30 slides. The flexibility of Leica Autostainer XL (ST5010) permits simultaneous processing of specimen slide holders according to various staining protocols. An oven is integrated into the instrument which accelerates drying of specimen slides. Optimized wash stations provide for rapid removal of reagent residue. The design of the specimen slide holders ensures minimal reagent displacement and prevents the reagents from being contaminated by liquid dripping into them and needing to be replaced prematurely. The Leica Autostainer XL (ST5010) is safe to use and has an integrated system for extracting reagent vapors. The specimen slide holders are loaded and unloaded using two drawers.

Leica Autostainer XL (ST5010)

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3 Instrument Features 21

1

2

20

3

19 18 4 5

17

6

16

7 8

11 15

9

14 13 10 12

Fig. 1

Front side of instrument 1

Transport arm

12

Reagent vessel

2 3 4 5 6 7 8 9 10 11

Wash stations Oven Notepad for staining protocols Recess for notepad ON/STOP switch Display screen Keypad LED indicators Specimen slide holder Container cover

13 14 15 16 17 18 19 20 21

Load drawer LED indicator and key for load drawer Exit drawer Cover with cut-outs (for vessel transportation) LED indicator and key for exit drawer Schematic diagram of the stations Cover plate Lock for hood1) Hood

The lock for the hood contains a gas pressure spring. This part can wear out. In case of weakening holding force, please contact our after-sales service and ask for replacement. 1)

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Instrument Features

3

1

7 6

5

14

9

4

10

11

3

12

13

8

2

Fig. 2

Rear side of instrument 1

Water inlet

8

Feet, adjustable

2 3 4

Drain outlet Serial port Power supply (electronics)

9 10 11

5 6 7

Voltage selector and fuses for heater Power switch (ON/OFF) Power input

12 13 14

Switched mains power inlet Nameplate Remote alarm socket, 30 V AC/1 A, 60 V DC/1 A Accessory port Exhaust air duct Switched mains power outlet

Note The Serial port (→ Fig. 2‑3) and the Accessory port (→ Fig. 2‑12) are used by the certified Leica service technician to install the optional Leica TS5015 Transfer Station which connects the Leica Autostainer XL (ST5010) with a Leica CV5030 Robotic Coverslipper (→ 5.9.9 Operation as a workstation‑12).

Leica Autostainer XL (ST5010)

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3 Instrument Features 3.2

Standard delivery – packing list Note To prevent damage to the instrument and specimens, only those accessories and spare parts that have been authorized by Leica may be installed or used with the instrument. Standard delivery: Qty.

Designation

Order No.

1

Leica Autostainer XL (ST5010) basic unit (230-240 V / 50-60 Hz) (local power cord included) - or Leica Autostainer XL (ST5010) basic unit (100-120 V / 50-60 Hz) (local power cord included) accessories kit (0456 35660) consisting of: reagent vessels with lids wash vessels, assy. specimen slide holders, metal covers with slots for reagent vessels jumper cable, power supply remote alarm connector tubing band clamp angular connecting nozzle for hose V filter 3/4. active carbon filter filter cover collecting tray for paraffin (heater) (inside the instrument) staining protocol notepad (attached to instrument) water supply hose with seal

14 0456 35136

1 1 22 5 5 2 1 1 1 1 1 1 1 1 1 1 1 1

14 0456 35340

14 0475 33659 14 0456 35268 14 0456 33919 14 0475 34486 14 0411 34604 14 6844 01005 14 0422 31972 14 0475 33669 14 0456 36101 14 0474 32273 14 0456 35240 14 0456 35216 14 0456 35459 14 0474 32325

drain hose 14 0475 35748 Instructions for Use, international bundle (including English 14 0456 80001 printout, language CD 14 0456 80200 and a reference manual as appendix, only in English (staining protocols, etc.))

If the supplied local power cord is defective or lost, please contact your local Leica representative. Note The delivered components must be carefully compared against the packing list, delivery note, and your order. Should you find any discrepancies, please contact your Leica sales office without delay.

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Instrument Features 3.3

3

Technical Data Dimensions (width x depth x height): Weight: Nominal supply voltages: Nominal frequency: Power draw: Fuses:

Means of protection according to IEC 61010-1: Overvoltage category according to IEC 61010-1: Pollution degree according to IEC 61010-1: Degree of protecion according to IEC 60529: A‑weighted noise level, measured at 1 m distance: Remote alarm socket: Performance parameters Slide throughput

Loading capacity: Capacity of one specimen slide holder: Overall number of stations: Reagent stations: Volume of reagent vessels: Overall number of water stations: Number of oven chambers: Temperature of oven chamber: Incubation time setting: Overall number of loading / unloading stations: Capacity of nonvolatile storage: Integration: Fresh water connection Hose material: Hose length: Connecting piece: Inner diameter: Outer diameter: Internal pressure: Required flow rate:

Leica Autostainer XL (ST5010)

109 cm x 67 cm x 51 cm 65 kg 100‑120V AC ± 10 % or 230‑240V AC ± 10 % 50‑60 Hz 650 VA 5 x 20 mm, VDE / UL listed 100-120 V: quick acting fuse F 6.30 A L250 VAC 230-240 V; quick acting fuse F 3.15 A L250 VAC Class 1 II 2 IP20 ≤ 70 dB (A) 30 V AC/1 A – 60 V DC/1 A depending on selected protocol: max. 600 slides /h min. 200 slides /h max. 11 specimen slide holders 30 slides 26 min. 18 450 ml max. 5 (DI water optional) 1 Ambient temperature or +30 to +65 °C 0 s to 99 min 59 s 1/1 15 programs with up to 25 steps Connection with CV5030 (coverslipper, optional) PVC 2.5 m G3/8 10 mm 16 mm Min. 1 bar / max. 6 bar Min. 12 l/ min

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3 Instrument Features Waste water connection Hose material: Hose length: Inner diameter: Outer diameter: Exhaust air Hose material: Hose length: Inner diameter: Outer diameter: Exhaust performance: Exhaust extraction: Ambient conditions Operating temperature: Operating relative humidity: Operating altitude: Storage temperature: Storage relative humidity: Transport temperature: Transport relative humidity:

20

PVC 4m 32 mm 36.8 mm PVC 2 m or 4 m 50 mm 60 mm 22.4 m3/h Active carbon filter and exhaust hose for connecting with an external exhaust system 15 to 35 °C 20 % to 80 %, non‑condensing Max. 2000 m above sea level +5 to +50 °C 10 % to 85%, non‑condensing -29 °C to +50 °C 10 % to 85%, non‑condensing

Version 3.1, Revision M

Installing the Instrument 4.

4

Installing the Instrument This chapter provides instructions on how to install the Leica Autostainer XL (ST5010). It also includes a diagram and detailed description of the instrument's components. The procedure for replacing the active carbon filter for protection against reagent vapors is outlined as well.

4.1

Installation site requirements • Required hard surface: 1.09 x 0.67 m2 • The laboratory bench must be of sufficient bearing capacity relating to the instrument and must have a rigid surface. • The device is intened for indoor use only • The next power socket must not be further away than the length of the power cord (2.5 m). Use of an extension cord is not allowed. • The instrument needs to be connected to a grounded power supply socket. • Use only the provided power cord intended for the local power supply • The instrument must not be installed below any air conditioning system • Any shaking, direct sunlight and significant current fluctuations need to be avoided • Proper function is ensured only if a minmum distance of 10 cm is respected towards all walls and any other fixtures • The instrument need to be installed in a way that allows easy access to the power switch and the power plug at the rear side. • Operation is not allowed in any areas exposed to explosion hazards • The installation site needs to be protected against electrostatic discharges • The installation site needs to be well ventilated because chemicals used within the instrument are highly flammable and unhealty • Connect the instrument to a laboratory air exhaust system using the dedicated hose (lenghts of 2 m and 4 m available). Alternatively the instrument can be operated below a fume cupboard. This should be run in addition to the active carbon filter. • Please consider that the active carbon filter supports only filtration of hazardous vapors (Xylene) • The situation at the installation site may vary significantly and depends on existing ventilation, emissions of other installed devices, the use of solvents, the volume of the room, etc. • It is the responsibilty of the laboratory owner / laboratory operator to not exceed the legal maximum permissible values and to take all measures at the working places regarding the solvent vapors. This includes also corresponding documentation. • The operator of the instrument needs to make sure that sufficient ventilation is ensured and the active carbon filter is replaced within the required interval. • The voltage selector and other internal components are preset by the manufacturer to meet the power requirements of the respective country of destination. Warning The user must not alter the voltage selector setting. • The Leica Autostainer XL (ST5010) must be connected to a laboratory water tap with a pressure reducer.

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