diapath Galileo SEMI 2 Series User manual

Galileo SEMI Series 2
Semiautomatic rotary microtome
User Manual

2
Manufacturer:
Diapath S.p.A.
Via Savoldini 71
24057 Martinengo (BG) Italy
Tel. [phone]
Fax [phone]
www.diapath.com
[e-mail]

3
Manual information
This document is protected by copyright laws; copyrights of this document belong to Diapath S.p.A.
It is strictly forbidden full or in part to modify this manual in absence of an explicit authorization.
Diapath S.p.A. is not obliged to regulate updates of this manual or to send regularly reviewed or updated versions of
this manual to its customers.
Information contained in this manual is subject to change without prior notice.
Diapath S.p.A. guarantees the accuracy of the information present in this manual as a result of thorough research; if
information is incorrect or unclear please contact Diapath S.p.A. or the distributor. Diapath S.p.A. is not responsible for
any kind of material damages or other damages related to non-compliance with indications or specific information
present in this manual.
Diapath S.p.A. continuously adopts a development policy and reserves the right to make changes and improvements to
any product described in this manual without prior notice.
The serial number and date of manufacture are reported on the registration plate attached on the rear part of the
instrument.
Inspired to:
Galileo Galilei (Pisa 15th February 1564 – Arcetri 8th January 1642) was an Italian physician
philosopher astronomer and mathematician considered the founder of modern science. His name is
associated with important theories in dynamics and astronomy such as telescope perfecting which
brought him to make important astronomic observations and to introduce the scientific method.
Fundamental were his role in the astronomic revolution support to the heliocentric system and to the
Copernican theory. His importance for the re-evaluation of science in general and of physics in particular
is connected to discoveries that he made through several experiments such as the principle of relativity
the discovery of Jupiter’s 4 moons which were called Galilean satellites the inertia principle and the
discovery that speed fall is the same for all bodies independently from material or mass
Manual Revision: Rev. 1
Edition date: 30
th
May 2018

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Contents
Preface ................................................................................................................................................................................. 5
Quality control ....................................................................................................................................................................... 6
Storage and handling ............................................................................................................................................................. 6
Safety information .................................................................................................................................................................
Definiton of adopted symbols ................................................................................................................................................ 8
1 Packaging instruction .............................................................................................................................................. 9
2 Galileo SEMI Series 2 components ......................................................................................................................... 15
2.1 Instrument overview ........................................................................................................................................... 15
2.2 Directional specimen holder fixture with quick clamping system ............................................................................. 16
2.2.1 Object clamp for Supermega cassettes (optional) ..................................................................................... 17
2.2.2 Universal clamp (optional) ....................................................................................................................... 17
2.2.3 Quick-lock kit .......................................................................................................................................... 17
2.3 Knife holder ........................................................................................................................................................ 18
2.4 Emergency stop push button ............................................................................................................................... 18
2.5 Local board ........................................................................................................................................................ 19
2.6 Remote control ................................................................................................................................................... 20
2.7 Controls before the use ....................................................................................................................................... 21
2.8 Instrument features ............................................................................................................................................ 21
2.9 Part Supplied – Packing list .................................................................................................................................. 22
2.10 Technical data .................................................................................................................................................... 23
3 Instrument setting ................................................................................................................................................. 24
3.1 Placement and installation ................................................................................................................................... 24
3.1.1 Requirements for the placement .............................................................................................................. 24
3.1.2 Unpacking .............................................................................................................................................. 24
3.2 Instrument starting up ........................................................................................................................................ 25
3.3 Quick installation guide ....................................................................................................................................... 26
4 Local board function .............................................................................................................................................. 29
4.1 Main screen ........................................................................................................................................................ 29
4.2 Alarm messages.................................................................................................................................................. 30
5 Remote control function ........................................................................................................................................ 31
5.1 Main screen ........................................................................................................................................................ 31
5.2 Configuration menu ............................................................................................................................................ 32
5.2.1 Time and date ........................................................................................................................................ 33
5.2.2 Language setting .................................................................................................................................... 33
5.2.3 Retraction configuration .......................................................................................................................... 34
5.2.4 Information screen ................................................................................................................................. 35
6 Microtome operation .............................................................................................................................................. 36
6.1 Semi-automatic sectioning mode ......................................................................................................................... 36
6.2 Semi-automatic sectioning with Remote control .................................................................................................... 36
6.3 Configuration of sectioning modes ....................................................................................................................... 37
6.4 Rock mode (Manual mode) .................................................................................................................................. 37
6.5 Handwheel calibration system .............................................................................................................................. 37
Cleaning and maintenance ..................................................................................................................................... 38
7.1 LCD display cleaning ........................................................................................................................................... 38
7.2 External surfaces ................................................................................................................................................ 38
7.3 Instrument cleaning frequency ............................................................................................................................ 38
7.4 Knife holder cleaning ........................................................................................................................................... 39
7.5 Clamp cleaning ................................................................................................................................................... 40
7.6 Section waste tray cleaning ................................................................................................................................. 40
7.7 Check orientation head........................................................................................................................................ 40
7.8 Fuses replacement .............................................................................................................................................. 40
8 Troubleshooting ..................................................................................................................................................... 41
9 WEEE Directive ....................................................................................................................................................... 42
9.1 Uninstallation and disposal .................................................................................................................................. 42
10 Diapath instrument warranty ................................................................................................................................ 42

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PREFACE
Destination of use
Galileo Series 2 is a semi-automatic rotary microtome for creating thin sections of paraffin embedded specimens. Suitable for specimens
of different hardness.
The instrument may be operated by trained and qualified staff only.
It is possible to set up all process parameters such as: specimen coarse feed cutting speed cutting and trimming thickness.
The reading of this manual and the maintenance are essential to use the equipment avoiding any dangerous situation.
The operators must be adequately trained in its use and respect all safety rules and its use limits.
Trained and authorized Diapath S.p.A. staff will perform instrument maintenance in case of failure or malfunction.
The microtome complies with CISPR 11 Class A rules: in case of domestic use it may cause radio interferences. In this case a
measurement and mitigation of such interference is necessary.
Before installing the instrument an analysis of electromagnetic interferences must be performed.
Do not use the device near sources of strong electromagnetic radiations such as radiofrequency wave generators. In this case the
radiations may interfere with the normal functioning of the instrument.
The Instrument has been designed according to the legislative decree 332/00 of 08th September 2000 “Accomplishment of 98/79/CE
directive of 27th October 1998 concerning in-vitro diagnostic medical devices” respecting electromagnetic compatibility rules:
•ISO 9001(*) quality management system. Requirements
•ISO 13485(*) quality management system requirements for medical devices. Requirements for regulatory purposes and
specific requirements of the application of ISO 9001 (*)
•UNI CEI EN ISO 14971(*) application of risks management to medical devices
•UNI EN ISO 18113-3(*) In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3: In
vitro diagnostic instruments for professional use
•UNI CEI EN ISO 15223-1(*) Symbols to be used with medical device labels labelling and information to be supplied. Part 1:
General requirements
•EN 61326-1(*) Electrical equipment for measurement control and laboratory use - EMC requirements Part 1: General
requirements
•EN 61326-2-6(*) Electrical equipment for measurement control and laboratory use - EMC requirements. Part 2-6: Particular
requirements - In vitro diagnostic medical devices (IVD)
•EN 61000-3-2(*) Electromagnetic compatibility (EMC) Part 3-2: Limits - Limits for harmonic current emissions. (equipment
with input current <= 16A per phase)
•EN 61000-3-3(*) + A1(*)+ A2(*) Electromagnetic compatibility (EMC) Part 3-3: Limits - Limitation of voltage fluctuations and
of flicker in low voltage supply systems for equipment with rated current <= 16A and not subject to conditional connection
•EN 61010-1(*) Safety requirements for electrical equipment for measurement control and laboratory use. Part 1: General
requirements
•EN 61010-2-101(*) Safety requirements for electrical equipment for measurement control and laboratory use. Part 2-101:
Particular requirements for medical equipment for in-vitro diagnostics
•The LED light according to standard EN62471 and classified in 1 Risk Group Category
(*) In the applicable edition

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Quality control
Diapath S.p.A. adopts quality management system ISO 9001(*) and ISO 13485(*) to design make and improve the technical-scientific
solution for the customer in medical and diagnostic in vitro systems assuring high quality services with the help of well-qualified
motivated staff to contribute to the improvement of Diapath S.p.A. products.
Diapath S.p.A. consistently aims for customer satisfaction trying to exceed expectations and to treat the customer without any
discrimination. Diapath S.p.A. assures the application of normative requirements.
Quality assurance of data furnished by Diapath S.p.A. is obtained through these activities:
•Use only reference material
•Execution of proofs of the whole production
•Correlation of different results
The internal quality control foresees to monitor the most difficult passages of an analytic process so as to verify their stability assuring
that quality parameters estimated during the validation or the checking of the method are valid also for real instruments and that they
will not worsen over the course of time.
Diapath S.p.A. tests its own products according to some internal procedures to reduce the possibility of anomalies during the
operation.
To identify and to service its own instruments Diapath S.p.A. uses some internal procedures which allow us to production recording
assembling recording tests recording serial number or batch code and configuration recording
Instrument information
All information present in this manual regard only the device shown on the cover.
On the instrument rear part there is the registration plate with the serial number (Picture 1).
Storage and handling
For correct conservation and functioning of the instrument all the instructions provided in this manual concerning the maintenance and
the installation must be respected. Also the environmental requirements shown below should be respected.
The instrument can work with 80% relative humidity conditions for temperatures up to 31°C with a linear decrease up to 50% at the
temperature of 40°C. Voltage variation cannot exceed +/-10% the nominal value.
The instrument is planned only for internal use and up to 2000 m o.s. altitude
Before turning on the instrument it is advisable to leave the unit until it reaches environmental conditions
Storage and transportation temperature range:
F
rom +5°C to +40°C
Storage humidity:
80%
Working temperature range:
F
ro
m +5°C to +40°C
Picture 1 – Registration plate
Due to size and weight (
4
0 Kg) the handling of the microtome must be perfo
rmed by several
people with
suitable
lifting means.

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Safety information
Mentioned agreement and graphic symbols
Danger - The danger instructions signal situations that might cause death or serious lesions.
Caution - The caution instructions signal situations that might cause physical lesions to people or damages to
things.
Biohazard - The biohazard instructions signal situations that might cause the contamination of people or parts
involved in the process.
Cutting and shearing - The cutting and shearing instructions signal situations that might cause lesions to the
operator.
Crush hazard - The crush hazard instructions signal situations where body parts might be crushed by moving
parts.
Instruction of danger
Never disassemble modify or repair the instrument or one of its parts without written authorization by Diapath
S.p.A.
Do not use any kind of different power supply from the mentioned ones
For use at voltages higher than 125V in the North American market electricity supply cables with NEMA 6-15P plug
C13 plug connector and STJ cable with nominal capacity 13A 250V must be used.
Instruction of caution
Do not place objects that are not involved in the use of the instrument.
The use of appropriated individual protection devices is recommended (For instance: gloves).
Instruction of biohazard
Pay attention to the possible biological hazard of the parts involved in the process.
Special individual safety measures should be used by operators in accordance with the safety standards in the
laboratories and product safety data sheets in relation to current rules.
Do not place objects that are not involved in the use of the instrument.

8
Safety training
All the operators must be trained to use the microtome safely. After such training the operators must have understood that:
•The microtome must be connected to a voltage source in accordance with electrical data label
•The use of the microtome differently from Diapath instructions might compromise its functioning and the safety of the operator
Users group
Galileo Series 2 must be used only by qualified and well-trained operators.
All users can proceed with the use of the device only after reading this user manual and when all technical details are familiar to them.
Compliance with safety rules
All regulations related to safety local codes and instructions that appear in the manual or on the equipment must be carefully observed
to ensure personal safety and to prevent damages to both the microtome and to the equipment connected to it. If the equipment is
used incorrectly the protection provided might be compromised.
Definiton of adopted symbols

9
1Packaging instruction
Place the pallet and put the polystyrene strip on the base (Picture 2) in central position as shown in the picture. Clearance frontal side
2 cm related to the frame (Picture 3).
Place the microtome over the polystyrene base. Instrument clearance frontal side must be at 3 cm from the frame (Picture3).
Instrument clearance lateral sides must be at 11 cm far from the pallet both right and left side.
Picture
2
Picture
3
3 cm
3
cm
11
cm
11
cm

10
Cover the instrument as shown in the picture. Avoid any kind of air bubble that may damage the instrument (Picture 4 -5 -6 -7).
Picture
4
Picture
5
Picture 6
Picture
7

11
Insert lateral side and let them adhere to the instrument (Picture 10- 11) - (Do not hit polystyrene high part).
Picture
9
Picture
1
0
Picture
1
0
Picture
1
1

12
Insert all elements as shown in the picture in the following order:
Dynamic control pedal / knife holder / remote control / waste tray / shelf (Picture 14-15-16).
Picture 13
Picture 15
Picture 12
Picture 14

13
Use the box (from the upper part) as shown in the picture (Picture 19 - 20).
Picture 20
Picture
16
Picture 19
Picture 17
Picture
18

14
Place polystyrene entirely over the closed box (Picture 21) and cover using the wood box as shown below (Picture 22).
Close the cover and fix it to the pallet (Picture 23 - 24).
Box with available accessories (Picture 24B)
Picture 22
Picture 23
Picture 24
Picture 21
Picture 24B

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2Galileo SEMI Series 2 components
2.1 Instrument overview
Picture 25 – Microtome overview
Emergency stop push button Directional specimen holder fixture
with quick clamping system
Backlit panel
Local board
Section waste tray
Knife holder with knife
guard
Handwheel with
electronic lock

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2.2 Directional specimen holder fixture with quick clamping system
To accomplish specimen orientation: loosen head release lever (n.1) using adjusting notches in order to obtain the orientation desired
and clamp the release lever. For parallel alignment it is necessary to loosen release lever (n.1) and rotate notches one at a time until a
“CLICK” sound is noted. “CLICK” sound indicates the Zero position achievement. Use both notches to obtain the resetting in both
directions (Clamp lever n.1). To quickly replace the clamp i.e. to replace the clamp for standard cassette and the one for macro-
cassettes release lever (n.1) hold the clamp with one hand and pull out the lever n.1. This procedure allows the clamp to be pulled
out through the adjustment procedure. Insert the desired clamp re-insert lever (n.1) and fix it in position.
Picture 26 – Universal cassette clamp
Adjusting setscrew with
position notch
Cassette release lever
Head release lever for
orientation
1
2
3
Picture 27 – Universal clamp cassette - Detail
ATTENTION
Before removing the clamp remove the blade holder

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NOTE: Hold the clamp and then remove the unlocking screw
2.2.1 Object clamp for Supermega cassettes (optional)
The clamp for mega-cassettes allows mega cassettes to be sectioned with maximum length of 67mm.
2.2.2 Universal clamp (optional)
Universal clamp kit is a screw-clamp that allows the application of cassettes of different dimension and shape on the directional
specimen holder.
2.2.3 Quick-lock kit
Kit applied on a second clamp that allows its installation and use of another specimen; it is necessary to loosen
unlock/orientation head lever only .
Picture
30
-
Clamp for
Supermega
-
cassette
Picture
31
–
Universal clamp
Picture 33 – Quick-lock kit - Detail
Picture 28 – Orientation system - Detail Picture 29 – Orientatation system - Detail
Picture 32 – Quick-lock kit - Detail

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2.3 Knife holder
To move the knife holder toward the specimen loosen lever 4 place the knife holder and close the loosen lever.
To insert the blade loosen lever 3 let the blade slide within its own section close the loosen lever.
Always cover cutting edge with knife guard when the instrument is not in use.
To remove the blade use the ejector after releasing lever 3.
To move the blade right and left release lever 1 mount the blade in the desired position and lock lever 1.
2.4 Emergency stop push button
The emergency stop push button is on the left side of the microtome. If it is pressed it stops movement immediately. The specimen
holder can be moved manually allowing the user to operate for safety measures.
To restore microtome functionality switch off the emergency stop push button and wait until the specimen holder completes its
placement at the beginning of horizontal feed (position 0).
ATTENTION
Always lock the specimen and then the clamp. Before any operation regarding the blade make sure that the
handwheel is locked and finger guard cover is in position.
Picture 34 – Knife holder
1-Clamping lever for
lateral displacement
2 - Knife guard with
ejector
3-Clamping lever
for the blade
4- Clamping lever
for knife holder
base
ATTENTION
Pay attention during blade handling they are very sharp and can causes serious lesions

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2.5 Local board
Local board display shows microtome status and possible alarms and messages. Also further sectioning information shown as:
•Position of specimen holder referring to horizontal feed
•Movement speed (from 0 to 150)
•Sectioning/Trimming mode and its thickness in µm
The microtome can even be used without the Remote control. It is possible to set parameters and start movements by disconnecting it
from the microtome.
The Local board is programmed with the following keys:
Set section thickness. If Trimming mode is ON changing trimming thickness; otherwise changing Sectioning in
thickness.
POSITION: specimen holder horizontal feed. If pressed moving the specimen holder in the desired position.
Pressing while is pressed the specimen holder homing at zero point
HOMING: Pressing this key the specimen holder reaches zero position (home)
TRIM/SECT: if pressed allows selection of either Sectioning (Sect) or Trimming (Trim)
LOCK/UNLOCK of microtome. When microtome is in LOCKED position the feed is mechanically locked. Press
UNLOCK icon to manually start microtome movement
Switching ON/OFF of backlit panel for an immediate backlit or overlapping section evaluation. It checks also the right
association between cassette and slide.
Picture 35 – Local board display

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2.6 Remote control
Remote control allows to set up microtome operating parameters. It displays the main parameters concerning current
sectioning/trimming session:
The Remote control is equipped with the following buttons:
•LOCK/UNLOCK of microtome. When microtome is in LOCKED position the movement is mechanically locked.
•POSITION: specimen holder horizontal feed. If pressed it allows moving of specimen holder in the desired
position
•TRIM/SECT:
oSectioning (Sect)
oTrimming (Trim)
NOTE: Active mode is displayed with a white-colored writing otherwise grey-colored writing appears.
•Set section thickness. If trimming mode is active it will modify trimming thickness; if not it will modify sectioning
thickness.
•MENU: press it to access to microtome configuration menu.
Use the following buttons to surf the menu:
o To choose the entry of the menu
o To confirm (and save) the selected entry of the menu
o To exit from current menu without saving
Picture 37 - Remote control interface
MENU key
Confirmation
MENU
Scroll MENU
Sectioning /
Trimming key
Section thickness
Approach/Retraction of
specimen
Electronic LOCK/UNLOCK
handwheel switch