Leica RM2235 User manual

Instructions for Use
Leica RM2235
Rotary Microtome
Leica RM2235 V 2.3, English 05/2018
Order No.: 14 0500 80101 RevH
Always keep this manual with the instrument.
Read carefully before working with the instrument.

1
Leica RM2235
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 pres-
ent manual periodically and on an ongoing basis
according to the latest technical developments,
nor to provide our customers with additional cop-
ies, 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 illus-
trations 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 state-
ments 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 process-
es without prior notice. Only in this way is it pos-
sible 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, photo-
copy, 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
NOTE
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com
Assembly contracted to Leica Microsystems Ltd. Shanghai

2Instructions for Use V 2.3 RevH – 05/2018
Table of Contents
1. Important Information ............................................................................................................... 4
2. Safety ........................................................................................................................................... 6
2.1 Safety notes................................................................................................................................... 6
2.2 Warnings........................................................................................................................................ 6
2.3 Integrated safety devices............................................................................................................ 8
3. Instrument Components and Specifications....................................................................... 10
3.1 Overview — instrument components ..................................................................................... 10
3.2 Instrument specifications.......................................................................................................... 11
3.3 Technical Data............................................................................................................................ 12
4. Instrument Setup........................................................................................................................ 13
4.1 Standard delivery........................................................................................................................ 13
4.2 Installation site requirements................................................................................................... 13
4.3 Unpacking and installation........................................................................................................ 14
4.4 Assembling the handwheel....................................................................................................... 16
4.5 Inserting the universal cassette clamp................................................................................... 17
4.6 Inserting the knife holder .......................................................................................................... 18
5. Operation..................................................................................................................................... 19
5.1 Operating elements and their functions ................................................................................. 19
5.1.1 Section thickness setting.......................................................................................................... 19
5.1.2 Coarse driving wheel ................................................................................................................. 19
5.1.4 Mechanical trimming function ................................................................................................. 20
5.1.3 Specimen retraction................................................................................................................... 20
5.1.5 Specimen holder with precision orientation.......................................................................... 21
5.2 Adjusting the clearance angle ................................................................................................. 22
5.3 Fine adjustment of the force balance...................................................................................... 23
5.4 Clamping the specimen ............................................................................................................. 24
5.5 Clamping the knife / disposable blade .................................................................................... 24
5.6 Sectioning.................................................................................................................................... 25
5.7 Changing the specimen or interrupting sectioning .............................................................. 26
5.8 Finishing the daily routine ......................................................................................................... 26
6. Optional Accessories................................................................................................................ 27
6.1 Assembly for fixture for specimen clamps............................................................................. 27
6.1.1 Rigid fixture for specimen clamps ........................................................................................... 27
6.1.2 Directional fixture for specimen clamps................................................................................. 27

3
Leica RM2235
Table of Contents
6.1.3 Fine-directional fixture for specimen clamps........................................................................ 28
6.1.4 Quick clamping system.............................................................................................................. 29
6.2 Specimen clamps and holders................................................................................................. 30
6.2.1 Standard specimen clamp ........................................................................................................ 30
6.2.2 Vee insert..................................................................................................................................... 31
6.2.3 Foil clamp type 1 ......................................................................................................................... 32
6.2.4 Universal cassette clamp.......................................................................................................... 33
6.2.5 Super mega-cassette clamp..................................................................................................... 34
6.2.6 Holder for round specimens ..................................................................................................... 35
6.3 Knife holder base and knife holder.......................................................................................... 36
6.3.1 Knife holder base, without lateral displacement feature .................................................... 36
6.3.2 Knife holder E/E-TC..................................................................................................................... 37
6.3.3 Knife holder N/NZ....................................................................................................................... 40
6.4 Section waste tray...................................................................................................................... 42
6.5 Backlighting................................................................................................................................. 42
6.6 Tray ............................................................................................................................................... 43
6.7 Freezer pack................................................................................................................................ 43
6.8 Universal microscope carrier .................................................................................................. 44
6.9 Magnifying lens .......................................................................................................................... 46
6.10 Additional accessories ............................................................................................................. 47
6.11 Ordering information.................................................................................................................. 62
7. Troubleshooting ....................................................................................................................... 64
7.1 Possible faults................................................................................................................................... 64
7.2 Instrument malfunctions ................................................................................................................. 66
7. Troubleshooting ....................................................................................................................... 66
8. Cleaning and Maintenance...................................................................................................... 67
8.1 Cleaning the instrument............................................................................................................. 67
8.2 Maintenance instructions......................................................................................................... 69
8.3 Lubricating the instrument........................................................................................................ 70
9. Warranty and Service ............................................................................................................... 71
10. Decontamination Certificate (Master) .......................................................................................... 72

4Instructions for Use V 2.3 RevH – 05/2018
Symbols in the text and their meanings
1. Important Information
(5)
Manufacturer
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
Date of Manufacture
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 in-
formation symbol .
Numbers in parentheses refer to item
numbers in illustrations.
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.
It allows maximum 3 stacks layers.
Indicates the temperature range per-
mitted for transporting the package.
Minimum -29 °C, Maximum +50 °C
Indicates the temperature range per-
mitted for storing the package.
Minimum +5 °C, Maximum +50 °C
Indicates the humidity range permit-
ted for storing and transporting the
package.
Minimum 10 % r.H., Maximum 85 % r.H
Tip-n-Tell indicator to monitor wheth-
er the shipment has been transported
and stored in upright position accord-
ing 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.

5
Leica RM2235
Intended use of instrument
The RM2235 is a 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!
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 at the left
side of the instrument. Fig. 1 is provided as an
example only and shows a valid nameplate for
this instrument.
Qualification of personnel
• TheLeicaRM2235maybeoperatedbytrained
laboratory personnel only.
• Alllaboratorypersonneldesignatedtooperate
the Leica instrument must read these Instruc-
tions for Use carefully and must be familiar
with all technical features of the instrument
before attempting to operate it.
1. Important Information
Fig. 1
In the Shockwatch system, a precision
glass tube shows shocks or impacts
that are above a specified intensity
through red coloration. Exceeding a de-
fined acceleration (g value) destroys
the surface tension of the liquid in the
interior of the tube. This causes the
indicator tube to change color.
Indicates the item can be recycled
where correct facilities exist.

6Instructions for Use V 2.3 RevH – 05/2018
Warnings — Safety notes on the instrument itself
2. Safety
• 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.
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.
This instrument is built and inspected according
to the Safety requirements for laboratory instru-
ments.
The current EC Declarations of Conformity can be
found on the Internet:
www.LeicaBiosystems.com
To maintain this condition and ensure safe
operation, the user must observe all notes and
warnings contained in these Instructions for Use.
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 clean the instrument.
To ensure trouble-free operation of the instrument, make sure to comply with the following
instructions and warnings.
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.
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.
These Instructions for Use must be ap-
propriately supplemented as required
by the existing regulations on accident
prevention and environmental safety in
the operator‘s country.

7
Leica RM2235
Safety instructions — working with the instrument
Warnings — Transport and installation
2. Safety
Safety instructions — working with the instrument
• Once unpacked, the instrument may be transported only in an upright position.
• Do not transport the instrument by holding it by the handwheel grips, coarse driving wheel or
the knob for setting the section thickness.
• The protective devices located on the instrument and the accessories must not be removed or
modified.
• 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.
• Always lock the handwheel before 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!
• When using cleaners, please comply with the safety instructions of the manufacturer and the
laboratory safety regulations!
Hazards — servicing and cleaning
• Prior to manipulating the knife and specimen, or changing the specimen or knife, and during
breaks, always lock the handwheel and cover the cutting edge with the knife guard.
• ALWAYS turn the handwheel clockwise; otherwise, the brake will not work properly.
• Always wear safety goggles when sectioning brittle specimens. Specimens may splinter!
• Specimen blocks must NOT be oriented 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 may cause damage to both specimen and knife!
• 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.

8Instructions for Use V 2.3 RevH – 05/2018
• 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.
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 micro-
tome base plate, the handwheel can be braked
in almost any position.
• Tobrake,rotatetheleverinacounterclock-
wise direction to position .
3
5
12 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.
• Tounlockthehandwheelbraketurnthelever
(3) back to its original position. Position .
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. 2