Leica SM2010 R User manual

Leica SM2010 R
Sliding Microtome
Instructions for Use
English
Order No.: 14 0508 80101 - Revision I
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 1.8, Revision I - 04.2021

3
Leica SM2010 R
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.
Note
Leica Biosystems Nussloch GmbH
Heidelberger Strasse 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 1.8, Revision I
Table of contents
1. Important Information ................................................................................................................................ 6
1.1 Symbols and their meanings.......................................................................................................................... 6
1.2 Qualification of personnele............................................................................................................................ 7
1.3 Intended purpose............................................................................................................................................. 7
1.4 Instrument type................................................................................................................................................ 7
2. Safety ............................................................................................................................................................ 8
2.1 Safety notes...................................................................................................................................................... 8
2.2 Warnings........................................................................................................................................................... 8
2.3 Integrated safety devices............................................................................................................................. 10
3. Instrument Components and Specifications........................................................................................ 12
3.1 Overview - instrument components ........................................................................................................... 12
3.2 Technical data................................................................................................................................................ 14
3.3 Instrument specifications............................................................................................................................. 15
4. Instrument Setup....................................................................................................................................... 16
4.1 Standard delivery........................................................................................................................................... 16
4.2 Site requirements .......................................................................................................................................... 16
4.3 Unpacking....................................................................................................................................................... 16
4.4 Setup................................................................................................................................................................ 17
4.5 Assembling the knife holder SN.................................................................................................................. 19
4.6 Assembling the blade holder SE ................................................................................................................. 23
4.7 Inserting the universal cassette clamp...................................................................................................... 28
5. Operation.................................................................................................................................................... 30
5.1 Operating elements and their functions .................................................................................................... 30
5.1.1 Section thickness setting............................................................................................................................. 30
5.1.2 Coarse driving wheel .................................................................................................................................... 30
5.1.3 Manual feed.................................................................................................................................................... 31
5.1.4 Automatic feed............................................................................................................................................... 32
5.1.5 Directional fixture for specimen clamps.................................................................................................... 32
5.2 Clamping the specimen in the universal cassette clamp (UCC)............................................................ 34
5.3 Clamping a disposable blade....................................................................................................................... 35
5.4 Replacing the pressure plate....................................................................................................................... 37
5.5 Inserting the knife.......................................................................................................................................... 39
5.6 Sectioning....................................................................................................................................................... 40
5.7 Changing the specimen or interrupting sectioning ................................................................................. 41
5.8 Finishing daily routine................................................................................................................................... 41
6. Cleaning and maintenance..................................................................................................................... 42
6.1 Cleaning the instrument................................................................................................................................ 42
6.2 Maintenance instructions............................................................................................................................ 43
7. Optional accessories ............................................................................................................................... 44
7.1 Ordering information..................................................................................................................................... 44
8. Troubleshooting ........................................................................................................................................ 51
8.1 Possible faults................................................................................................................................................ 51
8.2 Instrument malfunctions............................................................................................................................... 51

5
Leica SM2010 R
Table of contents
9. Warranty and Service .............................................................................................................................. 52
10. Decontamination Confirmation.............................................................................................................. 53

6Version 1.8, Revision I
Important Information
1
1. Important Information
1.1 Symbols and their meanings
Caution
Leica Biosystems GmbH assumes no liability for consequential loss or damage due to failure to
observe the following instructions, particularly in relation to transportation and package handling,
and failure to observe the instructions for handling the instrument carefully.
Symbol: Title of the symbol: Warning
Description: If this danger is not avoided, then this may result in
death or serious injury.
Symbol: Title of the symbol: Caution
Description: Indicates a potentially hazardous situation which, if
not avoided, could result in death or serious injury.
Symbol: Title of the symbol: Note
Description: Indicates a situation with the potential for property
damage which, if not avoided, could result in damage
to the machine or something in its vicinity.
Symbol: Title of the symbol: Item number
→"Fig. 7 - 1"Description: Item numbers for numbering illustrations. Numbers in
red refer to item numbers in illustrations.
Symbol: Title of the symbol: Function key
Start Description: Software symbols that have to be pressed on
the input screen are displayed as bold, gray and
underlined text.
Symbol: Title of the symbol: Manufacturer
Description: Indicates the manufacturer of the medical product.
Symbol: Title of the symbol: Manufacturing date
Description: Indicates the date when the medical device was
manufactured.
Symbol: Title of the symbol: CE Compliance
Description: The CE marking is the manufacturer's declaration
that the medical product meets the requirements of
the applicable EC directives and regulations.
Symbol: Title of the symbol: In vitro diagnostics (IVD) medical device
Description:

7
Leica SM2010 R
Important Information 1
Symbol: Title of the symbol: Observe the Instructions for Use
Description: Indicates the need for the user to consult the
instructions for use.
Symbol: Title of the symbol: Country of Origin
Description: The Country of Origin box defines the Country where
the final character transformation of the product has
been performed.
Symbol: Title of the symbol: UKCA Label
Description: 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.
Symbol: Title of the symbol: Order No.
Description: Indicates the manufacturer's catalog number so that
the medical device can be identified.
Symbol: Title of the symbol: Serial number
Description: Indicates the manufacturer's serial number so that a
specific medical device can be identified.
1.2 Qualification of personnele
• The Leica SM2010 R may be operated by trained laboratory personnel only. The instrument is
intended for professional use only.
• All laboratory personnel designated to operate the Leica instrument must read these Instructions for
Use carefully and must be familiar with all technical features of the instrument before attempting to
operate it.
1.3 Intended purpose
The Leica SM2010 R is a manually operated sliding microtome specifically designed for creating
thin sections of formalin fixed, paraffin embedded human tissue specimens of varying hardness
used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. It is intended for
sectioning soft and hard human specimens, as long as they are suitable for being cut manually. The
Leica SM2010 R is designed for in vitro diagnostic applications.
Any other use of the instrument is considered improper!
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 indicating the instrument serial number is attached to the rear side of the
instrument.

8Version 1.8, Revision I
Safety
2
2. Safety
Warning
Be sure to comply with the safety instructions and warnings provided in this chapter. 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 instruction manual is an important part of the product, which must be read carefully prior to
Instrument Setup 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.
Note
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.
Note
For current information about applicable standards, please refer to the CE Declaration of Conformity
and UKCA Certificates on our Internet site:
http://www.LeicaBiosystems.com
Warning
The protective devices on both instrument and accessories may neither be removed nor 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. Primarily responsible for accident-free operation is above all the owner of the instrument
and, in addition, the designated personnel who operates, services or cleans the instrument.
To ensure trouble-free operation of the instrument, make sure to comply with the following instructions
and warnings.

9
Leica SM2010 R
Safety 2
Warnings - Safety instructions / warning labels attached to the instrument
Warning
• 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
Warning
• Once unpacked, the instrument may be transported only in an upright position.
• Before transporting the instrument, the knife sledge must be locked with the locking knob
(→Fig. 1-2)!
• Do not transport the instrument by holding it by the knife sledge, coarse driving wheel or the knob
for setting the section thickness.
Warnings - Working at the instrument
Warning
• Be very careful when handling microtome knives or blades. The cutting edge is extremely sharp
and can cause serious injuries!
• Always wear work safety shoes and safety gloves!
• Never place a knife anywhere with the cutting edge facing upwards and never try to catch a falling
knife! Always put the knives back into the knife case when not in use!
• Always clamp the specimen block BEFORE clamping the knife.
• Lock the knife sledge and cover the knife edge with the knife guard prior to any manipulation of
knife/blade or specimen, prior to changing the specimen block and during all work breaks.
• Always wear protective glasses and a mask when sectioning brittle specimens!
• Risk of splintering!
Warnings - Cleaning and maintenance
Warning
• Before each cleaning, remove the knife or disposable blade!
• Do not use solvents that contain acetone or xylene!
• Ensure that liquids do not enter the interior of the instrument during cleaning!
• When using cleaners, please comply with the safety instructions of the manufacturer and the
laboratory safety regulations!

10 Version 1.8, Revision I
Safety
2
2.3 Integrated safety devices
The instrument is equipped with the following safety devices:
• Knife guard (→Fig. 1-1)on the blade/knife holder.
• Knife sledge locking knob (→Fig. 1-2)for the knife sledge.
Fig. 1
1
2
3
4
5
6
Knife sledge locking knob
The knife sledge is locked in place using the locking knob (→Fig. 1-2)that engages in the notch points
on the bar (→Fig. 1-3), thus holding the knife sledge securely. The bar has 11 notch points, with a
distance of 10 mm between each.
» Knife sledge locked (→Fig. 1-5)
» Knife sledge is movable (→Fig. 1-6)
Warning
Prior to changing the specimen or knife and before transporting the instrument, lock the knife sledge
(→Fig. 1-4)using the locking knob (→Fig. 1-2).

11
Leica SM2010 R
Safety 2
Knife guard on the blade holder
The blade holder is equipped with a tightly mounted knife guard (→Fig. 2-1). This makes it possible to
cover completely the cutting edge of the blade (→Fig. 2).
Fig. 2
1 1
Warning
Prior to any manipulation of the knife or specimen, or each change of specimen, and during breaks,
always cover the cutting edge of the blade/knife with the knife guard (→Fig. 2-1)!
Caution
When the knife guard is pushed over the blade, do not reach into the blade from below!

12 Version 1.8, Revision I
Instrument Components and Specifications
3
3. Instrument Components and Specifications
3.1 Overview - instrument components
Fig. 3
1
2
7
3
4
5
6
8
9
11
12
10
13
1Clamping lever for lateral displacement 8Lever for clamping the blade
2Universal cassettes clamp 9Blade holder SE
3Setscrew for orientation in cutting direction 10 Knife guard on the blade holder
4Specimen cylinder 11 Quick clamping system for holding the
specimen clamps
5Scaled adjusting knob for setting the section
thickness
12 Clamping lever for specimen orientation
6Coarse driving wheel 13 Adjustable instrument feet
7Lever for manual feed

13
Leica SM2010 R
Instrument Components and Specifications 3
Fig. 4
1
2
3
4
5
6
7
8
9
10
1Knife holder SN 7Knife sledge lock
2Knife guard on the knife holder 8Ergo handle for moving the knife sledge
3HN40 tensioning clamp 9Adjusting knob of automatic feed
4Setscrew for orientation perpendicular to
cutting direction
10 Knife sledge
5Removable section waste tray 11 Magnetic knife sledge immobilizer
6Clearance angle scale

14 Version 1.8, Revision I
Instrument Components and Specifications
3
3.2 Technical data
General
Approvals: The instrument-specific marks are located on the
name plate.
Operating temperature range: +18 °C to +30 °C
Operating relative humidity: 20% to max. 80% non-condensing
Operating altitude: Up to 2000 m above sea level
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
Microtome
Section thickness range: 0.5 - 60.0 μm
Section thickness settings: from 0.5 - 5.0 μm in 0.5 μm increments
from 5.0 - 10.0 μm in 1.0 μm increments
from 10.0 - 20.0 μm in 2.0 μm increments
from 20.0 - 60.0 μm in 5.0 μm increments
Automatic specimen feed: from 0 to 30 μm
Total specimen stroke: approx. 50 mm
Clearance angle adjustment: –3° to 10°
Maximum specimen size: 50 x 60 x 40 mm
Specimen orientation in cutting direction: ± 8°
perpendicular to cutting direction: ± 8°
Declination: 0° - 45° in cutting direction
Dimensions and weight
Width (with coarse driving wheel and Ergo
handle):
390 mm
Width (base plate): 256 mm
Depth: 430 mm
Height (total): 343 mm (with blade holder)
Working height (knife blade): 255 mm (measured from the table)
Weight (without accessories): Approx. 20 kg

15
Leica SM2010 R
Instrument Components and Specifications 3
3.3 Instrument specifications
• The Leica SM2010 R is a manually operated sliding microtome, designed as a low-maintenance
tabletop instrument with roller-guided knife sledges and automatic section thickness feed.
• Stable, torsion-free basic design with micrometer feed system in a closed housing, protected from
ingress of paraffin waste.
• The vertical cross roller bearings have a cover which provides reliable protection from ingress of
section waste.
• The instrument has an ergonomically optimized specimen head position; the smooth-running knife
sledge can be securely locked in 10 mm increments.
• Precise 8° XY orientation with defined zero position.
• Individually adjustable Ergo handle for easily moving the sledge.
• The sectioning window can be adjusted to the specimen size.
• The cutting thickness can be adjusted within the range of 0.5 μm to 60 μm; the automatic feed
functions in the range of 0.5 μm to 30 μm.
• Manual feed by pulling or pushing the feed lever.
• Depending on the version, the instrument is either fitted with a blade holder SE for disposable
blades or a knife holder SN for conventional knives. The blade holder and knife holder each have an
integrated knife guard. In the knife holder SN a blade rail can also be inserted for holding disposable
blades.
• The knife or disposable blade holder does not need to be removed for the clearance angle
adjustment.
• The smooth-turning, coarse driving wheel can be chosen with clockwise or counterclockwise
rotation.
• Different specimen clamps can be inserted in the quick clamping system.
• The instrument has an antistatic waste tray for holding a large volume.

16 Version 1.8, Revision I
Instrument Setup
4
4. Instrument Setup
4.1 Standard delivery
The Leica SM2010 R standard delivery includes:
Qty Designation Order No.
1 Leica SM2010 R basic instrument 14 0508 42258
1 Section waste tray 14 0508 42328
1 Tool set consisting of 14 0508 42983
1 Allen key size 6 14 0194 43634
1 Allen key with handle, size 4 14 0194 04782
1 Allen key T 25 14 0194 45250
1 Open-end wrench, size 10 14 0330 04158
1 Spare magnet 14 0508 44762
1 Dust protection cover 14 0212 18961
1 Pair of safety gloves, size S 14 0340 40859
1 Instructions for Use (printed English with language CD 14 0508 80200). 14 0508 80001
Note
The accessories ordered are included in a separate box.
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.
4.2 Site requirements
• Stable, vibration-free laboratory table with horizontal, flat table top, as far as possible vibration-free
ground.
• No other instruments nearby which might cause vibrations.
• Room temperature consistently between + 10 °C and + 40 °C.
• Free access to coarse driving wheel and knife sledge.
• The instrument is suitable for operation in enclosed rooms only.
4.3 Unpacking
Note
First check the shipment for external damages upon arrival.
If it is evident that the shipment was damaged during transport, please make a claim to the carrier
immediately.
• Open the packaging.
• Remove all foam material.
• Take out all accessories and the instruction manual.

17
Leica SM2010 R
Instrument Setup 4
4.4 Setup
Warning
Do not transport the instrument by holding it by moving parts, on the knife sledge, coarse driving
wheel or the knob for setting the section thickness.
• To lift the instrument from the box, hold it on the left and right of the housing (→Fig. 5), lift it out of
the foam cushion of the package and place it on a stable lab table.
• Remove all adhesive tape used as transport anchors.
Fig. 5
Loosening the transport locking screw of the knife sledge
Note
The locking knob (→Fig. 6-1)secures the knife sledge during transport.
In daily operation, it is also used to lock the knife sledge in place.
Fig. 6
1

18 Version 1.8, Revision I
Instrument Setup
4
Horizontal alignment
For safe and accurate work, it is important that all instrument feet are in uniform contact with the
installation surfaces.
The microtome is horizontally aligned at the factory. If a completely level or horizontal surface is not
available at the installation site, the instrument must be realigned.
To do so, the two instrument feet (→Fig. 7-1)on the right side of the instrument are height-adjustable.
• For alignment, loosen the locknuts (→Fig. 7-2)using a size 10 open-end wrench.
• Adjust the instrument feet (→Fig. 7-1)until the microtome is in a stable position at the installation
location according to requirements.
• Retighten the locknuts.
Fig. 7
2
1

19
Leica SM2010 R
Instrument Setup 4
Setting the Ergo handle
The Ergo handle (→Fig. 8-1), which is used to move the knife sledge, can be set individually to an
ergonomic gripping position.
• To do this, loosen the fastening screw (→Fig. 8-2)using a size 6 Allen key (→Fig. 8-3).
• Turn the handle (→Fig. 8-1)to the desired position and retighten the screw (→Fig. 8-2).
Fig. 8
3
1
2
4.5 Assembling the knife holder SN
Installing the intermediate plate
Warning
Important!
The mounting table must be absolutely clean and dry. There must not be any foreign particles on it.
Otherwise, sections could become contaminated.
• Lock the knife sledge (→Fig. 9-1)in place using the locking knob (→Fig. 9-2)so that it cannot be
moved.
• The intermediate plate (→Fig. 9-3)intended for the knife holder SN, is mounted on the mounting
table (→Fig. 9-4)of the knife sledge (→Fig. 9-1).
• As shown in (→Fig. 9), place the intermediate plate on the mounting table. Make sure that the two
index markings (→Fig. 9-5)are at the top and point towards the back.

20 Version 1.8, Revision I
Instrument Setup
4
Fig. 9
1
2
3
4
5
• Insert the five countersunk screws (→Fig. 10-1)(→Fig. 10-2) (→Fig. 10-3) (→Fig. 10-4)
(→Fig. 10-5)into the bores and tighten them crosswise (in the sequence shown in (→Fig. 10)) using
an Allen key T25 (→Fig. 10-6).
Fig. 10
6
3
5
2
1
4