Canova SDSCV9000 User manual

Product name: Canova embedding module
Code: SDSCV9000
Manual revision: 1
st
emission
Edition date: 03
rd
November 2011
Canova
Operating
Manual

Preface
Canova embedding module is a modern workstation for embedding histological specimens
in paraffin.
This manual describes instrument operating, safety and maintenance information.
The first section is “safety information” in which adopted symbols, warnings and precautions
are described.
The following section “specifications and installation” contains all information concerning
installation instructions and features.
The maintenance section is dedicated to cleaning, periodic requirements, disinfecting and
system controls.
Please read, understand and follow all manual sections carefully.

Index
MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
1.0 PREFACE ..........................................................................................- 1 -
1.1 Destination of use......................................................................- 1 -
2.0 SAFETY INFORMATION ...................................................................- 3 -
2.1 Mentioned agreement and graphic symbols...............................- 3 -
2.2 Instructions of danger ................................................................- 3 -
2.3 Instructions of warning...............................................................- 3 -
2.4 Instructions of biocontamination.................................................- 3 -
2.5 Safety training............................................................................- 4 -
2.6 Safety compliance .....................................................................- 4 -
3.0 STORAGE AND HANDLING..............................................................- 5 -
4.0 INSTRUMENT PLACEMENT AND INSTALLATION..........................- 6 -
4.1.1 Unpacking.....................................................................- 6 -
4.1.2 Before installing.............................................................- 6 -
4.1.3 Operating......................................................................- 7 -
5.0 INSTRUMENT SETTING....................................................................- 8 -
5.1 Destination of use......................................................................- 8 -
5.2 Operating procedure..................................................................- 8 -
5.2.1 Controls before operating..............................................- 8 -
5.2.2 Filling with paraffin in grain............................................- 9 -
5.2.3 Filling with liquid paraffin...............................................- 9 -
6.0 INSTRUMENT PARTS.....................................................................- 10 -
6.1 Paraffin reservoir .....................................................................- 10 -
6.2 Liquid paraffin dispenser..........................................................- 10 -
6.3 Paraffin collecting hot plate......................................................- 11 -
6.4 Paraffin collecting drawer.........................................................- 11 -
6.5 Cold spot .................................................................................- 12 -
6.6 Cassette warmer......................................................................- 12 -
6.7 Mold warmer............................................................................- 12 -
6.8 Workspace suction ..................................................................- 13 -
6.9 Heated forceps & tamper connection.......................................- 13 -
6.10 Foot pedal switch connection...................................................- 13 -
6.11 Control panel...........................................................................- 14 -
7.0 OPERATING PROCEDURE.............................................................- 17 -
7.1 CONTROL PANEL FUNCTIONS.............................................- 18 -
7.2 HEATED FORCEPS MENU.....................................................- 19 -
7.3 SETTING MENU......................................................................- 21 -
7.4 DATE and HOUR MENU.........................................................- 21 -
7.5 TEMPERATURE SETTING MENU..........................................- 22 -
7.6 PLANNING CALENDAR MENU...............................................- 23 -
7.7 ALARM MENU.........................................................................- 24 -
7.8 FILTER EXPIRY ALARM.........................................................- 25 -
7.9 EXPIRED FILTER ALARM ......................................................- 26 -

Index
MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
7.10 OVERHEATING ALARM .........................................................- 27 -
8.0 SWITCHING OFF PROCEDURE .....................................................- 27 -
9.0 PERFORMANCES AND LIMITATIONS...........................................- 28 -
10.0 QUALITY CONTROL .......................................................................- 29 -
11.0 SPECIFICS AND INSTALLATION...................................................- 30 -
12.0 CLEANING AND MAINTENANCE...................................................- 31 -
12.1.1 LCD display cleaning...................................................- 31 -
12.1.2 External surfaces ........................................................- 31 -
12.2 Instrument cleaning frequency.................................................- 31 -
13.0 FUSE REPLACEMENT....................................................................- 32 -
14.0 SCHEDULED MAINTENANCE........................................................- 33 -
14.1 Filter expiry..............................................................................- 33 -
14.2 Heated forceps & tamper expiry...............................................- 33 -
15.0 WEE DIRECTIVE .............................................................................- 34 -
16.0 TROUBLESHOOTING .....................................................................- 35 -
17.0 Spare part list..................................................................................- 37 -
18.0 MANUAL INFORMATION................................................................- 38 -
19.0 DEFINITION OF ADOPTED SYMBOLS...........................................- 39 -
20.0 Warranty..........................................................................................- 40 -
21.0 GENERAL INFORMATION..............................................................- 41 -
Inspired by:
Antonio Canova (Possagno, November,1,1757 – Venice, October,13,1822) was an talian sculptor,
considered the greatest exponent of Neoclassicism.
His art and his genius had a great and decisive influence in the sculpture of the era and was identified as
the "poet" of the ideal feminine beauty: it is enough to recall his works inspired by the Three Graces and
the The bathing Venus.
He studied how to follow the techniques of the ancient Greek sculptors: from drawing to sketch in baked
clay, earth or wax, materializing at once the real shape of the work.
Another special feature of his talent was work dressing, always refined at best, giving a gloss effect, that
accentuated their natural and splendid beauty; a beauty radiant of purity, according to the standards of the
most orthodox classicism, the representation of the idealized, universal and eternal beauty.
Antonio Canova worked for popes, kings, emperors and princes from all over the world, and was under the
influence and charm of the seventeenth-century sculptor Gian Lorenzo Bernini, the undisputed master of
the Baroque style.
n his sculptures he used to use the white marble that, with incredible skill, was able to make smooth and graceful.
The anatomical forms of his works are perfectly unique, the gesture motion always contained and measured, and this feature is shown in
one of his most famous sculptures: Cupid and Psyche.

Preface
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
1.0 PREFACE
1.1 Destination of use
Canova embedding module is a modern workstation for embedding histological specimens
in paraffin. It is equipped with an electronic system for the constant working temperature
control. IVD certified. Professional use of product.
Designed and built for embedding histological specimens in paraffin blocks, Canova
embedding center is intended for use in Anatomic Pathology laboratories for the following
tasks:
-
Melt solid paraffin and keep it liquid at pre-set temperatures
-
Fill the embedding molds with liquid paraffin, taken from the dispenser
-
Preserve the cassettes with specimens at the pre-set temperature.
The reading of this manual and the maintenance are very important for the product use in
order to avoid dangerous situations.
The operators shall be adequately trained about its use and must observe all safety rules
and its use limits.
Instrument maintenance, due to trouble or malfunctioning, shall be performed only by
trained and authorized Diapath S.p.A. staff.
The instrument complies with the rules CISPR 11 Class A: in case of domestic use, it may
cause radio interferences. In this case, it is necessary a measurement and mitigation of
such interference.
Before installing the instrument, perform an analysis of electromagnetic interferences.
Do not use the device near sources of strong electromagnetic radiations, such as radio
frequency generators. In this case the radiations may interfere with the normal instrument
functioning.
Instrument has been projected according to the legislative decree 332/00 of 08
th
September
2000 “Accomplishment of 98/79/CE directive of 27
th
October 1998 concerning in vitro
diagnostic medical devices” respecting electromagnetic compatibility rules:
Directive 2007/47/CEE concerning the update of directives 93/42/CEE on medical
devices 98/79/CEE and on in vitro medical devices, enter into force on 21/03/2010
with Legislative Decree 25/2010.

Preface
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
Legislative decree 27
th
January 2010 n.17, implementation of Directive 2006/42/EC
on machinery and amending Directive 95/16/EC on lifts
ISO9001:2008 Quality management systems - Requirements
ISO13485:2003 Medical devices -- Quality management systems -- Requirements for
regulatory purposes
UNI CEI EN ISO14971:2009 Application of risk management to medical devices.
UNI EN 591:2001 Instructions For Use For In Vitro Diagnostic Instruments For Professional
Use
UNI CEI EN 980:2009 Graphic symbols used for the medical devices labelling.
EN 61326-1:2006 Electrical Equipment for Measurement, Control, and Laboratory
Use - EMC Requirements. Part 1: General Requirements
EN 61326-2-6 :2006 Electrical equipment for measurement, control and laboratory use -
EMC requirements. Part.2- 6 : Particular requirements - In vitro diagnostic (IVD) medical
equipments
EN 61000-3-2:2006 Electromagnetic compatibility (EMC). Limits. Limits for harmonic current
emissions (equipment input current ≤16 A per phase)
EN 61000-3-3:1995 + A1:2001 + A2:2005 Electromagnetic compatibility (EMC) - Part
3-3: Limits-Limitation of voltage changes, voltage fluctuations and flicker in public low-
voltage supply systems, for equipment with rated current ≤16A per phase and not
subject to conditional connection
EN 61010 -1 (2001) Safety ordinances concerning measure electrical equipment, control and
for laboratory use. Part 1: General requirements
EN 61010 – 2 -101 Safety requirement for electrical equipment for measurement, control,
and laboratory use. Part 2-101 : Particular requirements for in vitro diagnostic (IVD) medical
equipment
EN61010-2-010:2003 Safety requirements for electrical equipment for measurement, control
and laboratory use.
EN62471 LED light classified according to rule and belonging to the Risk Group 1
category

Safety information
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
2.0SAFETY INFORMATION
2.1 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 or things damages.
Biocontamination – The caution instructions signal situations that might
cause parts or people contaminations.
2.2 Instructions 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.
2.3 Instructions of warning
– Do not place any foreign body on the instrument.
2.4 Instructions of biocontamination
– Keep attention to the possible biocontamination of the parts involving in the
process.
– We suggest using suitable individual protective media (for ex. gloves, etc..).

Safety information
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
2.5 Safety training
All the operators must be trained to use the instrument safely. After such training, the
operators have understood that:
•The instrument must be connected to a voltage source in accordance with
electrical data label.
•The use of the instrument differently from Diapath instructions might
compromise the supplied protections.
2.6 Safety compliance
All safety related regulations, local codes and instructions that appear in the manual
or on equipment must be observed to ensure personal safety and to prevent
damage both for the instrument and the equipment connected to it.
If equipment is used in a way not specified by the manufacturer, the protection
provided by the equipment might be impaired.

Storage and handling
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
3.0 STORAGE AND HANDLING
For a correct maintenance and instrument working, it is necessary to observe all the
instructions of this manual, and the environmental requisites below.
Storage temperature range Working temperature range
Storage humidity 80%
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
changes can’t exceed +/-10% the nominal value.
The instrument is projected only for internal use and up to 2000 m.o.s altitude.

Instrument placement and installation
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
4.0 INSTRUMENT PLACEMENT AND
INSTALLATION
4.1.1 Unpacking
Unpack instrument parts taking care to not damage them: each instrument part is
checked before the shipping.
Make sure about any serious damages to the packaging and to the instrument due to
the transport. In case of damages, please contact Diapath or the local distributor.
4.1.2 Before installing
Before the installation, please verify if the electrical supply sources are set according
to the data supplied by the manufacturer (see instrument features on Chapter 11.0
Chart 1).
Place the instrument on a plane, very stable, vibration-free surface, able to support
product weight (see instrument features on Chapter 11.0 Chart 1)
(for example a laboratory table with the following minimum dimensions 750x700 mm.
WxD)
A trouble-free working is guaranteed only when the instrument is installed at a
minimum distance of 20 cm from the walls and furnishings.
Make sure that the power cable is easily accessible and reachable.

Instrument placement and installation
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
4.1.3 Operating
Move the instrument safely (at least two people) considering its weight of about 40
kg. Use lifting devices if necessary.
Perform the following installation steps:
•Place the instrument. Make sure it is installed on a plane surface.
•Connect the instrument supply cable (Pic. 2). Be sure to perform this
operation with the instrument switched off (Pic. 1).
•
Switch on the instrument by pressing the key located in its rear part (Pic. 2)
and then the power key on the control panel.
Important!
Instrument must be connected to a ground socket!
DON’T use extension cords!
Pic. 2
Pic. 1

Instrument setting
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
5.0 INSTRUMENT SETTING
5.1 Destination of use
Canova embedding module has been designed and built for use in Anatomic Pathology
laboratories for embedding histological specimens in paraffin blocks and for the following
tasks:
-
Melt solid paraffin and keep it liquid at pre-set temperatures
-
Fill the embedding molds with liquid paraffin, taken from the dispenser
-
Preserve the cassettes with specimens at the pre-set temperature.
5.2 Operating procedure
5.2.1 Controls before operating
It is a good practice to perform the following operations, before starting up the
instrument:
•Verify if the power cord is in good conditions
•Check paraffin presence inside the melting reservoir
.

Instrument setting
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
5.2.2 Filling with paraffin in grain
Before switching on the instrument (even in Standby
mode), it is necessary to load in the reservoir about 3.5
kg of paraffin in grains.
It is a good practice to fill just below the reservoir rim
near to the reference mark. The aluminium reservoir is
heated uniformly and homogeneously; a complete
filling, as a matter of facts, increases and improves
paraffin melting.
The first paraffin to be melted will be the one closer to
the tank walls.
To speed up the paraffin melting is useful to close the reservoir lid.
5.2.3 Filling with liquid paraffin
Alternatively to the paraffin in grains, it is possible to fill the reservoir with paraffin,
previously melted by oven or dispenser (about 3.8 Lt).
In this case, the operations are similar to the previous ones:
•open the reservoir lid
•set the amount of paraffin to be filled
•take from the dispenser the necessary quantity
•pour very slowly the melted paraffin in the reservoir.
Attention!
When handling liquid paraffin, be careful to use all protective devices to
prevent the risk of burning.
Pic. 3

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
6.0 INSTRUMENT PARTS
6.1 Paraffin reservoir
The paraffin reservoir has a capacity of about 4 litres
and is located at the top of the instrument. To fill the
reservoir with solid paraffin, lift the lid and pour the
grains up to the reference mark. The reservoir is made
of aluminium and is whole heated. Paraffin melting
temperature is adjustable through an operator interface
(see the dedicated section) and can be set between
50°C and 70°C.
When standard conditions, the lid must be close, to
make homogenous and uniform the temperature inside
the reservoir.
On the dispenser hole has been placed a micro-filter, to block all the possible impurities,
present in the paraffin grains, or in the reservoir.
6.2 Liquid paraffin dispenser
The paraffin is delivered with a dedicated paddle. The flow can
be set by the small lever above the paraffin dispenser (Pic. 5).
Paraffin dispensing is done using the dedicated paddle; the
paraffin flow is delivered and falls in the centre of the mold or
cassette.
A dedicated heating has been studied for the dispensing tube
too and it is possible to set the operating temperature as
needed.
Important!
Never use recycled paraffin, to avoid contamination with dirty or unsuitable
one
.
Pic. 4
Pic.
5

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
6.3 Paraffin collecting hot plate
The hot plate has been designed paying
attention to dispose the exceeding paraffin in the
grooves.
The holes drain the refluent paraffin into the
collection drawer positioned below the hot plate
(Pic. 8).
The hot plate cleaning can be done by using a
brush or gauze, in order to carry the waste into
the disposal pipes.
The hot plate has a large area and allows to easily work both with standard and other
dimensions (ex Super mega macro) cassettes.
On the hot plate surfaces there are some forceps
wells (Pic. 7). The forceps (heated or not) can be
inserted with their tips inside the wells. The
grooves guarantee an ergonomic positioning of the
heated forceps.
6.4 Paraffin collecting drawer
The refluent paraffin drains from the hot plate thought the
holes and falls into the drawer, inside of which is placed a
disposable thermoformed container for the paraffin collection.
The drawer is not heated: the paraffin, in this way, solidifies
ensuring an easier disposal and cleaning.
Important!
Check the drawer filling and, if necessary, empty it.
Pic. 6
Pic.
8
Pic.
7

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
6.5 Cold spot
For the rapid molds cooling has been studied a cold spot, to
cool very quickly all kinds of molds on the market. Its big
dimensions (70x60mm) allow to easily work with any kind of
embedding.
The temperature reached by the cold spot could change
from -2 °C to +5 °C.
6.6 Cassette warmer
On the right of the hot plate, is placed a warmer for storage
of cassettes with specimens in paraffin. It is closed by a lid,
which can fold back inside the structure.
The warmer container is removable for an easy cleaning.
6.7 Mold warmer
On the right of reservoir, there is a mold warmer,
inside which it is possible to position the stainless steel
molds for the embedding cassettes containment. The
warmer container is removable for an easy cleaning.
The heating temperature could be adjusted as
needed.
Attention!
Very low temperatures can cause the formation of ice on cold spot surface.
The ice has a negative effect on its efficiency.
Depending on operating conditions, periodically remove it.
.
Pic.
10
Pic.
9
Pic.
11

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
6.8 Workspace suction
To ensure operator safety, the instrument is equipped
with a suction tube below the dispenser, able to
suction any harmful vapours on the workspace during
routine operations.
6.9 Heated forceps & tamper
connection
At the bottom part of the instrument, next to
the collection drawer, there are 2 connectors
for the heated forceps and tamper.
To connect them, just screw the forceps or the
tamper connector to the relative one on
instrument (Pic. 13).
6.10 Foot pedal switch connection
In the back part of the instrument, there is the foot pedal switch connecting port. To connect
them, just screw the plug to the connecting port (Pic. 16).
Pic.
12
Pic. 13
Pic. 15
Pic.
14

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
6.11 Control panel
All instrument parameters can be set and managed by
the keyboard, with 14 keys, on the control panel.
The reached temperatures and all information are
displayed on the colour 4.3' LCD.
KEY NUMBERING
The instrument panel consists of:
-
Six keys for menu selection (keys 1-2-3-4-5-6).
-
Two keys to adjust the LED spotlight brightness (keys 7-8).
-
One key for the stand-by function (9).
-
Five keys for navigation and confirmation in the planning and display menu (Keys 10-
11-12-13-14).
Press the key 7 to decrease the LED light brightness.
Press the key 8 to increase the LED light brightness
Press the key 9 to access STANDBY mode. The display shows the Diapath logo, with
reduced display brightness.
For the general instrument switching on / off, press the key back on the instrument.
Press key 10 to increase the values or to move upwards the cursor in the different
menus.
Pic. 16
Pic. 17

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
Press key 11, in the different menus, to move the cursor leftwards.
Pres key 12 to confirm the values set in the different menus.
Press key 13, in the different menus, to move the cursor rightwards.
Press key 14 to increase the values or to move downwards the cursor in the different
menus.
USED SYMBOL:
From the main screen (Pic. 34), press this key to display the temperature of the 3
heated area (reservoir, hot plate and cassette warmer).
Icon to access ALARMS MENU; press this key to access MENU for instrument
ALARM management.
Icon to access FORCEPS MENU. Press the key to enter MENU for the management
of the parameters concerning HEATED FORCEPS.
This icon indicates the remaining time to the next heated forceps expiry date.
Icon to access SETTING MENU; press the key to access MENU for the management
of instrument SETTINGS.
Icon to access DATE AND TIME MENU; press the key to enter MENU for DATE and
TIME adjustment.
Icon to change the data set in the menu.
Icon to confirm the data changed in the menu

Instrument parts
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MU_EN_Operating_Manual_Canova_embedding module_Rev.I°emiss_031111
Press this key to clear the data just changed in the menu and return to the previous
setting.
Icon to access TEMPERATURES SETTING MENU; press the key to access
TEMPERATURE adjustment.
Icon to access MENU for setting of holder temperature.
Icon to access MENU for setting of cold spot temperature.
Icon to access the PLANNING CALENDAR MENU; press the key to access MENU
for the planning of instrument switching on/off, based on a weekly calendar.
This icon (in the PLANNING CALENDAR MENU) identifies the hour of instrument
switching on in that day.
This icon (in the PLANNING CALENDAR MENU) identifies the hour of instrument
switching off in that day.