ASP6025 S Instructions for Use Rev D V1.3 Sept 2020

NOTE 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 Instructions for Use periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of these Instructions for Use. To the extent permitted in accordance with the national legal system as applicable in each individual case, we shall not be held liable for erroneous statements, drawings, technical illustrations etc. contained in these Instructions for Use. In particular, no liability whatsoever is accepted for any financial loss or other consequential damage caused by or related to compliance with statements or other information in these Instructions for Use.

Statements, drawings, illustrations and other 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 documentation 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

Leica Biosystems Nussloch GmbH Heidelberger Strasse 17 - 19 D-69226 Nussloch, Germany Germany Phone: +49 62 24 143-0 Fax: +49 62 24 143-268 Internet: http://www.LeicaBiosystems.com Assembly contracted to Leica Microsystems Ltd. Shanghai ASP6025 S Tissue Processor

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Table of Contents 1.   Important Information...7 1.1 1.2 1.3 1.4

2.

Safety... 12 2.1 2.2 2.3

3.

Safety notes... 12 Warnings... 12 Safety features on the instrument... 17

Instrument Components and Specifications... 18 3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.4.3

4.

Symbols in the text and their meanings... 7 Instrument type... 10 Qualification of personnel... 10 Intended use of instrument... 11

Standard delivery - packing list... 18 Technical data... 20 Compatible reagents... 23 Overview... 24 Instrument components and accessories... 25 Instrument rear panel - terminals... 26 Instrument specifications... 27

Instrument Setup... 30 4.1 Unpacking the instrument... 30 4.2 Basic instrument/hardware... 37 4.2.1 Installation site requirements... 37 4.3 Installing the tube for external exhaust air (optional)... 38 4.4 Connecting the power supply... 40 4.4.1 The retort... 41 4.4.2 Counter area... 45 4.4.3 Specimen baskets... 46 4.4.4 The monitor ... 47 4.4.5 The paraffin station... 48 4.4.6 The paraffin baths... 49 4.4.7 Drawer with RTU-bottles... 51 4.4.8 Reagent cabinet with system bottles... 54 4.4.9 The drip tray... 55 4.4.10 Adhesive labels for system bottles and RTU-bottles... 56 4.5 Switching the instrument on... 58 4.6 Alarm functions... 60

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Instructions for Use V 1.3 RevD – 09/2020

Table of Contents 4.7 4.8

5.

Touchscreen functions... 63 Switching off the instrument correctly... 67

Operation... 68 5.1 System configuration - configuring the instrument parameters ... 68 5.1.1 The Installation menu... 68 5.1.2 System settings... 71 5.1.3 User profiles... 80 5.1.4 The System monitor menu... 82 5.1.5 The Service functions menu... 84 5.1.6 System status... 86 5.1.7 The Run log... 89 5.1.8 The Long-term error log... 91 5.1.9 Saving or loading data... 92 5.1.10 The Smart Screen... 97 5.2 Reagents... 100 5.2.1 Editing the reagent list... 100 5.2.2 The RMS system - adjusting warning threshold values... 102 5.2.3 The reagent status... 106 5.2.4 Configuring the stations... 108 5.2.5 The Reagent groups menu... 109 5.2.6 Ethanol rotation... 110 5.2.7 Adjusting the threshold value for ethanol rotation... 113 5.2.8 Replacing xylene... 114 5.3 Infiltration programs... 115 5.3.1 Display of the program list... 115 5.3.2 Adding and modifying programs... 116 5.4 Reagent handling... 119 5.4.1 Filling/draining reagents... 119 5.4.2 Refilling paraffin... 125 5.4.3 Draining a paraffin bath ... 127 5.5 Running programs... 129 5.5.1 User-defined programs... 129 5.5.2 Favorites... 130 5.5.3 Defining Favorite programs... 131 5.5.4 Starting a program... 134 5.5.5 Ending a program... 138 5.6 Permanently installed infiltration programs... 139

ASP6025 S Tissue Processor

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Table of Contents 5.6.1 5.6.2 5.6.3

Programs with automatic ethanol rotation... 139 Preinstalled xylene infiltration programs... 143 Xylene-free infiltration programs... 149

6.   Cleaning and Maintenance... 155 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.2 6.3 6.3.1 6.3.2 6.4

Cleaning programs... 155 View cleaning programs... 155 Running cleaning programs... 156 Cleaning protocols... 159 SMART cleaning... 160 General instrument maintenance... 166 Maintenance overview... 168 Daily cleaning and maintenance... 170 Periodic cleaning and maintenance... 173 Taking the instrument out of service temporarily... 174

7.   Troubleshooting... 175 7.1 7.1.1 7.1.2 7.2 7.3 7.4 7.4.1 7.4.2

Troubleshooting... 175 Power failures... 175 Instrument procedure in case of power failure... 176 Malfunctions in the program sequence... 179 Typical fill or drain problems... 180 Emergency unlock... 181 Electrical standard emergency unlock... 181 Mechanical emergency unlock... 182

8.   Optional Accessories... 183 9.

Warranty and Service... 184

10.   Log for Instrument Status... 185 11.

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Decontamination Confirmation... 186

Instructions for Use V 1.3 RevD – 09/2020

1.   Important Information 1.1

Symbols in the text and their meanings Warnings appear in a gray box and are marked by a warning triangle . Notes, i.e. important user information appears in a gray box and is marked by an information symbol .

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. ON position of a key with click stop

OFF position of a key with click stop Inflammable solvents and reagents are ­identified using this symbol. Instrument surfaces which become hot during operation are marked with this symbol. Avoid direct contact with these surfaces – they may cause burns. Warning – Dangerous electrical voltage.

(5) START

Numbers in parentheses refer to item ­numbers in illustrations. The instrument is controlled and operated ­using a touch-sensitive screen. Function keys to be pressed on the instrument touchscreen are written in bold-print capital letters. Warning instructions on the dust cover of the instrument.

ASP6025 S Tissue Processor

Manufacturer: Indicates the manufacturer of the medical product. Date of Manufacture: Indicates the date when the medical device was manufactured.

Observe the Instructions for Use!

In vitro diagnostics (IVD) medical device. This product fulfills the requirements of the Council’s Directive 98/79/EC concerning in vitro diagnostics (IVD) medical devices. 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.

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1.

Important Information

Symbols in the text and their meanings The CSA test mark means that a product has been tested and fulfills the applicable safety and/or performance standards, including the relevant standards defined or administered by the American National Standards Institute (ANSI), Underwriters Laboratories (UL), the Canadian Standards Association (CSA), the National Sanitation Foundation International (NSF) and others. 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.

~

Symbol for alternating current

REF

Order number for standard delivery or accessories.

SN

Designates the serial number of the instrument. The package contents are fragile and must be handled with care.

Indicates the correct upright position of the package.

The package must be kept in a dry environment.

It is not permitted to stack packages, and no loads may be placed on top of the package.

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Instructions for Use V 1.3 RevD – 09/2020

1.   Important Information Example of labeling in accordance with IPPC 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) Indicates the temperature range permitted for storing and handling the package. Minimum +5 °C Maximum +50 °C

Indicates the temperature range permitted for transporting the package. Minimum -40 °C Maximum +55 °C

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 arrowshaped indicator window and sticks there permanently. Improper handling of the shipment is immediately detectable and can be proven definitively.

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1.

Important Information

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. The ASP6025 S Tissue Processor is available in two voltage variants, 120 V and 230 V.

1.3 • •

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Qualification of personnel The ASP6025 S Tissue Processor may be operated by trained laboratory personnel only. The instrument is intended for professional use only. All laboratory personnel designated to operate this instrument must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.

Instructions for Use V 1.3 RevD – 09/2020

1.   Important Information 1.4

Intended use of instrument The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory ­applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use. The ASP6025 S modular tissue processor can be operated only with the reagents listed in Chapter 3.3 - "Compatible reagents".

Any other use of the instrument is considered improper. 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.

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2.

Safety 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 products.

2.1

Safety notes

These Instructions for Use include important instructions and information related to the operating safety and maintenance of the instrument.

This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control, and laboratory use.

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.

To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use.

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 protective devices located on the instrument and the accessories must not be removed or modified. Only service personnel qualified by Leica may repair the instrument and access the instrument’s internal ­components.

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, make sure to comply with the following instructions and warnings.

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Instructions for Use V 1.3 RevD – 09/2020

2.   Safety Warnings – Markings on the instrument itself Markings on the instrument itself 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. Some instrument surfaces become hot during operation. They are marked with this warning label. Touching these surfaces may cause burns.

Transport and Installation • Once unpacked, the instrument may be transported only in an upright position. Follow the unpacking ­instructions carefully to avoid damage to the instrument! • Before each transport, the drawer must be secured (e.g. using adhesive tape) so that it cannot open by itself. • Electromagnetic compatibility, emitted interference and immunity to interference are applicable, as are the requirements in accordance with IEC 61326‑1. The requirements in accordance with IEC 61010‑1, IEC 61010‑2‑101, IEC 61010‑2‑010 and ISO 14971 with regard to safety information are applicable. It is the user's responsibility to make sure that a compatible electromagnetic environment is maintained so that the instrument can work as intended. • 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. Make sure to observe the voltage settings! The set voltage CANNOT be changed by the user. Severe damage may occur if the instrument is connected to a power supply voltage other than that to which it was originally set. • The installation location must be well ventilated, and must contain no sources of ignition of any kind. The chemicals to be used in the ASP6025 S Tissue Processor are easily inflammable and hazardous to health. • Do not operate the instrument in rooms with explosion hazard. • 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. Failure to comply with this may cause damage to the instrument. • After the instrument has been put into service, a SMART cleaning must be carried out before each sub­ sequent transport – otherwise, the interior of the instrument can be severely damaged (see Chapter 6.1.4).

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2.

Safety

Warnings – Operating the instrument • The instrument may be operated by trained laboratory personnel only. It must only be operated for the ­purpose of its designated use and according to the instructions contained in these Instructions for Use. • Antistatic protective clothing made from natural fibers (e.g. cotton) should be worn when working with the instrument. • In an emergency, the instrument can be switched off via the ON/OFF switch located on the rear of the ­instrument. • Before opening the retort when an infiltration process is in progress, always press the unlocking mechanism switch below the screen, so that the retort is ventilated or vented. • The hose for remote filling/draining is cleaned with compressed air after the filling or draining process. ­Therefore, never remove the hose before a filling or draining process has been completed. • After refilling/replacing system bottles, close the container covers again tightly. The system bottles must be properly pushed home into the connection manifolds at the back panel of the reagent cabinet. Failure to plug the system bottles into the manifold correctly will interrupt the infiltration 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 and thus may never be used. • After every filling with paraffin, the retort must be cleaned with a retort cleaning program. • Never start a program without baskets in the retort. Otherwise, problems can occur in the air system, which lead to malfunctions in the instrument function. • NEVER lean on the drawer when it is pulled out. The instrument could tilt forwards and lead to personal injury or damage to the instrument. • When fully loaded, the drawer is very heavy. Therefore, always close it carefully. • Always close the spigot on the drip tray in the drawer. Liquid that has spilled in the drawer could end up on the hot paraffin bath oven, evaporate, and produce hazardous vapors. • Connection of an external alarm system is absolutely necessary for preventing damage to or loss of tissue samples in the event of a malfunction.

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Instructions for Use V 1.3 RevD – 09/2020

2.   Safety Warnings – Operating the instrument (continued) • 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 3.4 times per hour and a room temperature of 40 °C, room volume of 18 m3 and reagent temperature of 45 °C have shown that limit values are exceeded for short ­periods during the step when specimens are reloaded 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.

Warnings – Handling reagents • Take care when handling solvents and reagents! • To prevent damage to the instrument, only the reagents listed in Chapter 3.3 may be used! • Some of the reagents used in tissue infiltration are toxic, highly flammable and combustible and hazardous to health. Therefore, always wear rubber gloves and safety goggles when handling the chemicals used in this instrument. The gloves must be resistant to all reagents listed in the reagent list. • Use caution when handling paraffin wax or removing baskets – molten paraffin is hot and may cause burns. Also, avoid personal contact with paraffin containers and retort walls – they can be very hot as well. Observe the warning symbols for hot surfaces! • 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. • Never replace reagents or fill empty system bottles or RTU-bottles while a process is running. • This can result in severe damage to the instrument.

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2.

Safety

Warnings – Maintenance and cleaning • Do not use solvents that contain acetone for cleaning. Liquid must not get into the instrument while ­operating or cleaning it. • When using cleaners, comply with the safety instructions of the manufacturer and the safety regulations of your laboratory! • Check the condensate container at least once a week and, if necessary, drain it. • System bottles and Leica RTU-bottles must not be cleaned in a dishwasher - the containers are NOT dishwasherproof.

Material safety data sheets can be obtained from the supplier of the chemicals. Alternatively, they can be downloaded from the following website: http://www.msdsonline.com

Problem solution for hazard warning Warning! Misuse of the emergency unlock function and improper opening of the retort Injuries to hands, arms and head when opening the retort and/or injuries due to spraying reagents! • Only use the mechanical emergency unlock function if the standard emergency unlock (see Chap. 7.4.1) did not work and you absolutely must get to the specimens. • Wear special protective clothing, gloves and safety goggles. • Grasp the bolt handle of the retort firmly in your hand. • Ensure that no part of the body is located in the opening area of the retort lid. • Since the retort may be under pressure, open the bolt handle very carefully and slowly.

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Instructions for Use V 1.3 RevD – 09/2020

2.   Safety 2.3

Safety features on the instrument

Overpressure protection

The ASP6025 S tissue processor is equipped with numerous 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 infiltration process and that the infiltration is completed successfully. • •

Overcurrent protection

• •

Overheating protection

When power is switched off the pressure air pump and valves default to a safe condition (retort vented, no pressure generation). If the pump is not stopped at the correct moment during the pressurization, the power supply is interrupted by a separate electronic circuit. In addition, there is a safety relief valve that vents all excess air pump output to atmosphere. Overcurrent conditions are protected against by both the main fuse and the separate heating power fuses.

An error is indicated and all heating is stopped by the microprocessor control if the instrument detects any of the following conditions: • Abnormally high temperature (>75 °C), • Contradictory results of the temperature sensors. • Failure of one or more heating power control components. • If the microprocessor fails to interrupt heating power, independent temperature limiting hardware circuits limit the temperature rise to a safe level. • If the temperature limiting circuits malfunction, an independent hardware thermal fuse circuit cuts power to the heating elements. Over vacuum protection •

ASP6025 S Tissue Processor

The vacuum system is not capable of generating a dangerous vacuum condition.

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3.

Instrument Components and Specifications

3.1

Standard delivery - packing list

The ASP6025 S Tissue Processor is available in two voltage variants, each of which have a different scope of delivery. The country specific power cord needs to be ordered separately. Please find a list of all power cords available for your device on our website www.LeicaBiosystems.com within the product section. Immediately after taking delivery, check the delivery against the packing list below to ensure that it is complete. 230 V variant 1 ASP6025 S Tissue Processor Basic instrument 230 V

Order No. 14 0495 59058

120 V variant 1 ASP6025 S Tissue Processor Basic instrument 120 V

14 0495 59068

Both instrument variants of the ASP6025 S Tissue Processor also come with the following accessories:  1 Basket handle 3 Cassette basket assemblies, with lid, handle, separating wall and spiral inserts 1 Filling and draining hose for remote filling and draining of reagents 1 Filling and draining hose for remote draining of paraffin 7 RTU-bottles with cover, plastic 10 System bottles, plastic  1 Condensate bottle, plastic  2 Active carbon filters (1 x already installed in the instrument) 3 Paraffin baths 1 Flange kit for connection to external ventilation 1 Molykote 111 lubricant, 100 g, for valves and O-rings 1 Stirrer

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Order No. 14 0476 34713 14 0476 34193 14 0495 44794 14 0495 46467 14 0495 43542 14 0495 43329 14 0495 43537 14 0495 43860 14 0495 45423 14 0495 43827 14 0336 35460 14 0495 46070

Instructions for Use V 1.3 RevD – 09/2020

3.   Instrument Components and Specifications Standard delivery - packing list (continued) 

Order No.

1 1 1 1

14 0476 35923 14 0495 43593 14 0495 45243 14 0495 48279 14 0476 39720 14 0253 45880 14 0495 44976 14 0461 36136

Paraffin scraper, plastic Drip tray for system bottle cabinet  Sieve holder for retort Maintenance kit consisting of: 2 spare covers for system bottles 9 O-rings 2 Spare covers for RTU-bottles 1 Replacement seal for cover (set of 10) 1 Set of adhesive labels for system bottles consisting of differently colored adhesive labels 1 Set of adhesive labels for RTU-bottles consisting of differently colored adhesive labels with Min - Max 1 Paraffin station sieve 1 Paraffin station lid 3 Perforated trays for drawer 2 Compartment dividers for drawer 1 USB memory stick 1 Instructions for Use (printed in English with additional languages on data carrier 14 0495 8A200) 1 Allen key, size 3.0 1 Hexagon key, with handle 90 mm x 166 mm 1 Cleaning tool for prisms of the level sensors 1 Microfiber cloth 1 Shield for retort level sensors  1 Connector male 3-pole (remote alarm)  2 O Ring 24 x 1.5

14 0495 59781 14 0495 59083 14 0495 43987 14 0495 44021 14 0495 43602 14 0495 43603 14 6000 03467 14 0495 8A001 14 0222 04138 14 0194 58333 14 0495 47955 14 0495 47736 14 0495 46048 14 6000 04778 14 0253 45704

You will find these as well as other accessories you may have ordered packed in a separate carton. Carefully check the delivery against the packing list and the delivery note. Should you find any discrepancies, please contact your Leica sales office without delay.

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3.

Instrument Components and Specifications

3.2

Technical data

Nominal supply voltages: Two factory-preset voltages (not user-adjustable): 120 V or 230 V Nominal frequency: 50 to 60 Hz Main fuses: 2 melting fuses, 32 x 6.3 mm, UL-approved • for 120 V; T 15 A 125 VAC • for 230 V; T 10 A 250 VAC Nominal power: 1700 VA for both versions Dimensions, (L x W x H), in mm: 680 x 750 x 1500 Empty weight, unpacked: Max. 210 kg Weight, packed: Max. 235 kg Operating temperature range: +15 °C to +40 °C Storage temperature range: +5 °C to +50 °C Relative humidity: 10 % to max. 80 % non-condensing IEC 61010-1 classification: Protection class 1 Pollution degree 2 Overvoltage installation category II: Ambient pressure: 740 to 1100 hPa Operating elevation: Up to a max. of 2000 m above sea level A-weighted noise level: < 70 dB (A) Local/remote alarm: 0-30 V DC/AC, 0-1 A 2 terminals for 6.3 mm stereo jack. Each with isolated switching contact (operable both as normally-open and normally-closed circuit) Paraffin containers Paraffin melting station: Number of paraffin baths: Capacity: Melting time: Temperature:

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1 3 4.9 l per paraffin bath / 5.0 l in paraffin melting station In paraffin station: max. 6.0 h, in paraffin bath max. 12.0 h 50 to 65 °C (+6 K - 0 K) Instructions for Use V 1.3 RevD – 09/2020

3.   Instrument Components and Specifications 3.2

Technical data (continued)

Retort Capacity: max. 300 cassettes Reagent volume: 4.8 l (up to fill level of 3rd sensor, without specimen filling) Temperature (paraffin): 50 °C to 65 °C (+6 K - –2 K) Temperature (processing reagents): Ambient temperatures or 35 °C to 60 °C (+4 K / -2 K) Temperature (cleaning reagents): 50 °C to 67 °C (+4 K - –0 K)

General System bottles: RTU-bottles: Condensate bottle: Cleaning solution bottles: Maximum bottle volume: Pretest check:

9 (in reagent cabinet) 6 (in drawer) 1 3 (not additional) 5.0 l ON/OFF

System setup Password status: Type of password: Reagent management system (RMS): Software interlock:

Supervisor/Operator alphanumeric, freely selectable Toggle between RMS and concentration measurement ON/OFF

Network protocols used Remote Care uses the TCP/IP network protocol and, at the user level, https (128-bit encrypted). No other network protocols are used.

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