RM2245 Instructions for Use Rev J June 2018

NOTE The information, numerical data, notes and value judgments contained in this manual represent the current state of scientific knowledge and state-ofthe-art technology as we understand it following thorough investigation in this field. We are under no obligation to update the present 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 as regards contents or technical details of the present Instructions for Use are not to be considered as 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 ­attached to the instrument. © Leica Biosystems Nussloch GmbH

Leica Biosystems Nussloch GmbH Heidelberger Str. 17 - 19 D-69226 Nussloch 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. Leica RM2245

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TABLE OF CONTENTS 1.

Important Information... 4 1.1 1.2 1.3 1.4

2.

Safety... 6 2.1 2.2 2.3

3.

Standard delivery... 15 Installation site requirements... 15 Unpacking and installation... 16 Assembling the handwheel... 18 Electrical connections... 18 Switching on the instrument... 20

Operation... 21 5.1 5.1.1 5.1.2 5.1.3 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10

6.

Overview - instrument components... 11 Instrument specifications... 12 Technical Data... 13

Instrument Setup... 15 4.1 4.2 4.3 4.4 4.5 4.6

5.

Safety notes... 6 Warnings... 6 Integrated safety devices... 9

Instrument Components and Specifications... 11 3.1 3.2 3.3

4.

Symbols in the text and their meanings... 4 Qualification of personnel... 5 Intended use of instrument... 5 Instrument type... 5

Operating elements and their functions... 21 Instrument control panel... 21 Control panel... 22 Display and control elements... 23 Inserting the knife holder... 30 Inserting the universal cassette clamp... 31 Adjusting the clearance angle... 32 Clamping the specimen... 33 Clamping the knife / disposable blade... 33 Cutting into the specimen (trimming)... 35 Sectioning... 35 Changing the specimen or interrupting sectioning... 36 Finishing the daily routine... 36

Optional Accessories... 37 6.1 Assembly for fixture for specimen clamps... 37 6.1.1 Rigid fixture for specimen clamps... 37 6.1.2 Directional fixture for specimen clamps... 37 6.1.3 Fine-directional fixture for specimen clamps... 38 6.1.4 Quick clamping system... 39

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Instructions for Use V 2.4 RevJ - 06/2018

TABLE OF CONTENTS 6.2 Specimen clamps and holders... 40 6.2.1 Standard specimen clamp... 40 6.2.2 Vee insert... 41 6.2.3 Foil clamp type 1... 42 6.2.4 Universal cassette clamp... 43 6.2.5 Super mega-cassette clamp... 44 6.2.6 Holder for round specimens... 45 6.3 Knife holder base and knife holder... 46 6.3.1 Knife holder base, without lateral displacement feature... 46 6.3.2 Knife holder E/E-TC... 47 6.3.3 Knife holder N/NZ... 50 6.4 Blades/knives... 52 6.4.1 Disposable blades... 52 6.4.2 Knife... 52 6.5 Section waste tray... 54 6.6 Backlighting... 54 6.7 Tray... 55 6.8 Freezer pack... 55 6.9 Universal microscope carrier ... 56 6.10 Magnifying lens ... 58 6.11 Cold light source ... 59 6.12 Fiber-optic light guide... 59 6.13 Ordering information... 60

7.

Troubleshooting... 62 7.1 7.1.1 7.1.2 7.2

8.

Cleaning and Maintenance... 66 8.1 8.2.1 8.2 8.2.2 8.2.3

9. 10.

Instrument malfunctions... 62 Error reports... 62 Malfunctions, possible causes and troubleshooting... 63 Possible faults... 64 Cleaning the instrument... 66 Replacing fuses... 68 Maintenance... 68 Maintenance instructions... 69 Lubricating the instrument... 70

Warranty and Service... 71 Decontamination Certificate... 72

Leica RM2245

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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 .

(5)

Numbers in parentheses refer to item numbers in illustrations.

RUN/ STOP

Function keys which must be pressed on the control panel are shown in the text in bold capital letters.

Manufacturer Date of Manufacture This product fulfills the requirements of the Council's Directive 98/79/EC concerning in vitro diagnostics (IVD) medical devices. In vitro diagnostics (IVD) medical device Observe the Instructions for Use Order No. Serial number It allows maximum 3 stacks layers.

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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 on the bringing into circulation, return and environmentally compatible disposal of electrical and electronic equipment. 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. Environmental protection symbol of the China RoHS directive. The number in the symbol indicates the "Environmentfriendly Use Period" of the product. The symbol is used if a substance restricted in China is used in excess of the maximum permitted limit. The package contents are fragile and must be handled with care. The package must be kept in a dry environment. Indicates the correct upright position of the package. Indicates the temperature range permitted for transporting the package. Minimum -29 °C, Maximum +50 °C Instructions for Use V 2.4 RevJ - 06/2018

1.   Important Information 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 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. In the Shockwatch system, a precision glass tube shows shocks or impacts that are above a specified intensity through red coloration. ­Exceeding a defined acceleration (g value) destroys the surface tension of the liquid in the interior of the tube. This causes the indicator tube to change color.

tions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.

1.3

Intended use of instrument

The RM2245 is a semi-motorized (motorized specimen feeding), manually operated rotation microtome specifically designed for creating thin sections of human tissue specimens of varying hardness for histological medical diagnosis, e.g. cancer diagnosis. It is intended for sectioning soft and hard human specimens, as long as they are suitable for being cut manually. Any other use of the instrument will be considered as improper use!

1.4

Instrument type

All information provided in these Instructions for Use applies only to the instrument type indicated on the title page. A nameplate with the serial number is fastened to the left side of the instrument (this figure is only symbolic).

Indicates the item can be recycled where correct facilities exist.

1.2

Qualification of personnel

• The Leica RM2245 may be operated by trained laboratory personnel only. • All laboratory personnel designated to operate the Leica instrument must read these InstrucLeica RM2245

Fig. 1

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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 instructions, 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 information related to the operating safety and maintenance of the instrument. The Instructions for Use are an important part of the product, and must be read carefully prior to startup and use and must always be kept near the instrument. These Instructions for Use must be appropriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator‘s country.

This instrument has been built and tested in accordance with the safety regulations for electrical measuring, control, regulating and laboratory devices. To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use. For current information about applicable standards, please refer to the CE declaration of conformity on our Internet site: www.LeicaBiosystems.com

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 a­ ccident prevention. Operating the instrument safely is, above all, the responsibility of the owner, as well as the designated personnel who operate, service or clean 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 2.4 RevJ - 06/2018

2.   Safety Warnings - Safety notes on the instrument itself • Safety notes on the instrument itself, which are marked with a 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 result in an accident, personal injury, damage to the instrument or accessory equipment.

Warnings - Transport and installation • Once unpacked, the instrument may be transported only in an upright position. • Never lift the instrument by the handwheels or the cassette clamp. Always remove the section waste tray before transporting the instrument. • Caution! The voltage selector has been preset at the factory. • Before connecting the instrument to the line voltage, please check that this setting complies with the local power requirements of your laboratory. • The power cable inlet is closed with an adhesive tape that indicates the actual voltage setting of the instrument upon arrival. Severe damage can be caused to the instrument if the voltage selector is set to an incorrect voltage! • When changing the voltage selector setting, ensure that the instrument is not connected to the line voltage! • The instrument must be connected to mains only with one of the supplied power cords and only to grounded sockets. • The instrument may not be operated in hazardous locations. • 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. • The protective devices located on the instrument and the accessories must not be removed or modified.

Personal safety precautions • When working with microtomes, personal safety precautions must always be taken. It is mandatory to wear work safety shoes, safety gloves, a mask and safety goggles.

Leica RM2245

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2.

Safety

Safety instructions - working with the instrument • Take care when handling microtome knives and disposable blades. The cutting edge is ­extremely sharp and can cause serious injuries! • Always remove the knife / blade before detaching the knife holder from the instrument. ­Always put the knives back into the knife case when not in use! • Never place a knife anywhere with the cutting edge facing upwards and never try to catch a falling knife! • Always clamp the specimen block BEFORE clamping the knife or blade. • Lock the handwheel and cover the knife edge with the knife guard prior to any manipulation of knife or specimen clamp, prior to changing the specimen block and during all work breaks! • ALWAYS turn the handwheel clockwise; otherwise, the brake will not work properly. • Always take appropriate safety precautions when sectioning brittle specimens! Specimens may splinter! • Ensure that liquids do not enter the interior of the instrument during work! • Do not attempt to clamp, approach or orient the specimen during the retraction phase. • If a block is oriented during retraction, the block will advance by the retraction value PLUS the selected section thickness before the next section. This involves the risk that the specimen collides with the knife/blade! Prior to sectioning, check that the specimen is securely clamped in the specimen clamp – failure to observe this poses the risk of damaging the specimen.

Hazards - servicing and cleaning • Only authorized and qualified service personnel may access the internal components of the instrument for service and repair! • Before each cleaning, switch off the instrument, disconnect the power plug, remove the knife holder completely and clean it separately. • Always remove the knife / blade before detaching the knife holder from the instrument. • Lock the handwheel before each cleaning! • Do not use any solvents containing acetone or xylene for cleaning! • Ensure that liquids do not enter the interior of the instrument during cleaning! • Do not turn the instrument on before it is completely dry! • When using cleaners, please comply with the safety instructions of the manufacturer and the laboratory safety regulations! • Turn the instrument off with the power switch and disconnect the power plug before ­replacing the fuses! Only use fuses of the same specification! For fuse specifications, refer to Chapter 3.3 - "Technical Data".

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Instructions for Use V 2.4 RevJ - 06/2018

2.   Safety 2.3

Integrated safety devices Locking the handwheel There are two ways of locking the handwheel (12): Using the lever (3) on the right side of the microtome base plate, the handwheel can be braked in almost any position. • To brake, rotate the lever in a counterclockwise direction to position .

5

Caution! The braking lever (3) must be exactly in position , so that the handwheel brake is applied correctly. If the lever is moved beyond this point, it is possible that the handwheel is no longer braked.

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• To unlock the handwheel brake turn the lever (3) back to its original position. Position . • To lock the handwheel, press the lever (5) outwards and continue to turn the handwheel slowly until it locks exactly in the 12 o'clock position.

3

In both cases the yellow LED (4) in the LOCK will be lit and the instrument cannot be started.

Fig. 2 4

When using both brake systems at the same time, always move the lever (3) to position  first. Otherwise, it may be not be possible to release the lever (5).

Fig. 3 Leica RM2245

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2.

Safety 7

Knife guard on the knife holder

Knife holder N 7

8

Each knife holder is equipped with a tightly mounted knife guard (8, 9). This makes it possible to cover completely the cutting edge in every knife or blade position. Knife holder N/NZ The knife guard (8) of the knife holder N/NZ can be easily positioned via the two handles (7) (Fig. 4). To cover the knife edge, push both cover strips of the knife guard to the center.

Fig. 4

Knife holder E/E-TC Knife holder E

10

9 11

The knife guard on knife holder E/E-TC consists of a red foldaway handle (9). To cover the cutting edge, fold the knife guard handle (9) upwards as illustrated in Fig. 5. The clamping levers on the knife holder E are not interchangeable. The two clamping levers (10, 11) must remain in the position shown at all times, as otherwise isolated malfunctions of the knife holder can occur. Clamping lever for the blade (10) at the right, clamping lever for the lateral displacement (11) at the left.

Knife holder E-TC

9 Fig. 5

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Instructions for Use V 2.4 RevJ - 06/2018

3.   Instrument Components and Specifications 3.1

Overview - instrument components

Instrument control panel

Directional specimen holder fixture with quick clamping system

Handwheel locking mechanism

Smooth-turning Handwheel Lever of Handwheel brake

Separate Control panel

Clamping lever for lateral displacement

Knife guard on the blade holder

Section waste tray

Blade holder E with lateral displacement Knife/blade holder base

Fig. 6

Leica RM2245

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3.

Instrument Components and Specifications

Rear side of instrument Vents Magnet for holding the wrench size 4 Voltage selector switch with fuses Main switch

Connecting cable for control panel

Power supply

Fig. 7

3.2

Instrument specifications

The Leica RM2245 is a semi-motorized rotary microtome with a light-action handwheel. The RM2245 supports two manual sectioning modes: rocking mode and conventional sectioning with full turns of the handwheel. All important controls are grouped in a userfriendly manner on a separate control panel with adjustable inclination. Important information on the operating status of the instrument such as retraction, locking, trimming thickness, section thickness, and counters for the total number of sections and total thickness sectioned is displayed directly on the instrument. The instrument features two independent handwheel locking systems for enhanced user safety. It also features an adjustable retraction system.

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The retraction value can be selected as required. The motorized specimen head can be moved at two speeds (300 µm/s and 800 µm/s). The coarse drive speed and direction can be controlled via buttons at any time. The minimum and maximum specimen head end positions are signaled visually and acoustically. The section thicknesses for trimming and sectioning mode can be programmed and stored independently of each other. A ruler integrated in the base of the microtome facilitates restoring a previous knife holder base position.

Instructions for Use V 2.4 RevJ - 06/2018

3.   Instrument Components and Specifications 3.3

Technical Data

General Approvals: The instrument-specific marks are located next to the identification label. Nominal supply voltages: Nominal frequency: Maximum power consumption: Protection class : Power fuses: Pollution degree : Overvoltage category : Maximum heat emission: Operating temperature range: Temperature range during storage: Relative humidity: Storage humidity: 

100/120/230/240 V AC ±10 % 50/60 Hz 70 VA I 2 x T 1.0 A UL listed 2 II 70 J/s +10 °C to +35 °C +5 °C to +50 °C max. 80 % non-condensing min. 10 % r.H., max. 85 % r.H.

according to IEC-1010, UL 3101, EN 61010

Dimensions and weight Basic instrument Width (including handwheel): Width (excluding handwheel): Depth (including waste tray): Height (total): Working height (knife blade): Working height (knife blade): Weight (without accessories):

Control panel Width: Depth: Height: Height (in inclined position): Weight (net): Leica RM2245

413 mm 300 mm 563 mm (small) / 618 mm (large) 305 mm (with tray on the hood) 100 mm (measured from the base plate) 168 mm (measured from the table) approx. 29 kg 94 mm 164 mm 50 mm 81 mm approx. 0.53 kg

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3.

Instrument components and specifications Microtome Sectioning thickness setting: Section thickness setting range: Setting values:

0.50 - 100 µm from 0.50 - 5.0 µm in from 5.0 - 20.0 µm in from 20.0 - 60.0 µm in from 60.0 - 100.0 µm in

0.5 µm increments 1.0 µm increments 5.0 µm increments 10.0 µm increments

Trimming section thickness setting range: Setting values:

1 - 600 µm from 1.0 - 10.0 µm in from 10.0 - 20.0 µm in from 20.0 - 50.0 µm in from 50.0 - 100.0 µm in from 100.0 - 600.0 µm in

1.0 µm increments 2.0 µm increments 5.0 µm increments 10.0 µm increments 50.0 µm increments

Specimen feed:

24 mm ±1 mm, feed motion via step motor

Vertical stroke: 70 mm Maximum sectioning area w/o retraction: 65 mm without specimen orientation Maximum sectioning area with retraction: 60 mm Specimen retraction: in manual sectioning mode: 5 - 100 µm in 5 µm increments; can be turned off -

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Electric coarse feed:

300 µm/s and 800 µm/s

Repositioning of knife holder base North-south:

± 24 mm

Lateral displacement function via blade holder CE clamping top: East-West:

3 positions

Maximum specimen size (L x H x W):

50 x 60 x 40 mm

Specimen orientation Horizontal: Vertical:

± 8° ± 8°

Instructions for Use V 2.4 RevJ - 06/2018

4.   Instrument Setup 4.1

Standard delivery

The Leica RM2245 standard delivery includes: 1 Leica RM2245 basic instrument, without orientation... 14 0501 38178 1 handwheel, complete ... 14 0501 38181 1 external control panel... 14 0501 38179 1 section waste tray ... 14 0502 37931 1 tool set - consisting of:... 14 0502 37965 1 Allen key with handle No. 5... 14 0194 04760 1 Allen key with handle No. 4... 14 0194 04782 1 Allen key No. 3 ... 14 0222 04138 1 screwdriver 3x50, 186 long... 14 0170 11568 1 bottle (50 ml) of oil for drives, type 405... 14 0336 06086 2 micro-fuses 1.0 AT... 14 6000 04804 1 brush w/magnet... 14 0183 40426 1 dust protective cover... 14 0212 30350 1 Instructions for Use printed (German/English, with Language CD 14 0501 80200) ... 14 0501 80001 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. The accessories ordered are included in a separate box. Carefully check the delivery against the packing list and the delivery note. Should there be any discrepancy, please contact the Leica selling unit handling your order.

4.2

Installation site requirements • Stable, vibration-free laboratory bench with horizontal, even stage plate; practically vibration-free floor. • No other instruments nearby which might cause vibrations. • Room temperature consistently between +10 °C and +35 °C. • Obstruction-free access to the handwheel. Never operate the instrument in rooms with an explosion hazard.

Leica RM2245

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4.

Instrument Setup

4.3

Unpacking and installation When the instrument is delivered, check the tilt indicators on the packaging. If the arrowhead is blue, the shipment was transported laying flat, was tilted at too great an angle or fell over during transport. Note this on the shipping documents and check the shipment for possible damage. Fig. 8

• Remove the packing strap and the adhesive tape (1). • Remove the carton lid (2). • Take the accessory carton (optional accessories) (3) and the cartons (4) from the standard scope of delivery.

1 2

1

The transport carton and included retaining elements should be kept in case a return shipment is necessary later.

3 4 5

4 4

4

Fig. 9

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Instructions for Use V 2.4 RevJ - 06/2018

4.   Instrument Setup 4.3

Unpacking and installation (cont.) •

5

6

• • 7

Take out the fixing module (5). To do so, hold it by the top edge of the module and in the recessed grip (6) and pull it out by pulling upwards. Remove the outer carton wall (7). Lift the instrument* (8) by holding it by the base plate at the front and under the instrument on the back and lift it out of the formed cushion (9).

Never hold the instrument for transport by the handwheel or the rotary knob for section thickness adjustment.

8 9

•

(*= the instrument illustration is provided as an example only.)

• Place the instrument on a stable laboratory table. The two sliding elements (10) located on the rear of the base plate make it easier to move the instrument on the table. • To move the instrument, hold it by the front of the base plate, lift it up gently and slide it on its slides.

10

Observe the correct resting angle to the table to avoid pinching your fingers.

Fig. 10 Leica RM2245

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4.

Instrument Setup

4.4

Assembling the handwheel The handwheel has to be assembled before attempting to use the instrument. The necessary parts and tools can be found in the toolkit. 4 1

2 3

5 Fig. 11

4.5

The feather key (4) is loosely placed in the handwheel shaft (1) and fixed in place with a cable tie during transport. • Remove the cable tie. Caution! Make sure not to lose the feather key! • Place the handwheel (2) on the handwheel shaft (1) as shown. • Tighten the screw (3) located in the center hole of the handwheel with an Allen key size 4 (5). • Remove the cover foil from the self-adhesive cover disk (6) and fix the cover disk on the handwheel.

Electrical connections The instrument MUST be connected to a grounded power socket. Use only the power cable provided that matches the power supply (outlets) of the country of use. Do not use an extension cable!

Checking the voltage The Leica RM2245 can be connected to various electrical power grids (depending on voltage and frequency) and, for this reason, is always delivered with a set of various power cables. New instruments are factory-set to 230 volts. This is documented by a yellow label (230 VOLT) on the rear of the instrument, which covers the power switch and power socket.

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Before connecting the instrument to the power supply, be absolutely certain to check that the voltage selector is set to the voltage in use in your area! Severe damage can be caused to the instrument if the voltage selector is set to an incorrect voltage! Never change the setting of the voltage selector while the instrument is connected to the power supply.

Instructions for Use V 2.4 RevJ - 06/2018

4.   Instrument Setup Checking the voltage (continued) 22 21

25

27

23

24

21

The voltage selector is located above the main power switch, on the left-rear side of the instrument (Fig. 7). The voltage setting is displayed in the viewing window (22). • Insert a small screwdriver into the cutout (25) and carefully pry out the insert. • Remove the voltage selector housing (21) together with the fuses (23). Remove the voltage selector block (24) (white) and insert it again such that the correct local voltage is displayed in the viewing window (22). • Reinsert the voltage selector housing with the block and fuses and push it in until it engages (audible click).

26 Fig. 12

Connecting the control panel The connecting cable (15) of the control panel is fixed to the microtome. It may not be disconnected.

14

17

15

• Insert the plug (14) of the connecting cable (15) into the connecting jack (16) on the rear of the control panel. • To fasten the plug, tighten the two screws (17).

16 Fig. 13 Leica RM2245

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