Mu S36S66 e Ed1r0

STEAM STERILIZER
S36/S66 SERIES
OPERATOR’S MANUAL
MU-S36S66-E-ED1R0 – 17/03/ 2012

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MU-S36S66-E-ED1R0 2 / 79
CONTENTS
1 SAFETY NOTES AND PRECAUTIONS ................................................................................................... 5

2 MACHINE DESIGNATION AND DEFINITIONS ....................................................................................... 6
2.1 Manufacturer 6
2.2 Product 6
2.3 Operator 7
2.4 Responsible authority 7
2.5 Documentation 7
2.6 Marking 8
3 TECHNICAL DATA ................................................................................................................................... 9
3.1 Intended use 9
3.2 Classification and reference standards 10
3.3 Composition of the product 12
3.4 Load stowing accessories 14
3.5 Chamber accessories 16
3.6 Load handling accessories 16
4 STERLIZATION AND TESTING CYCLES ..............................................................................................17
4.1 General information 17
4.2 Sterilization cycle phases 18
4.3 POROUS LOAD Cycle 19
4.4 RUBBER LOAD cycle 20
4.5 METAL LOAD cycle 21
4.6 CONTAINER LOAD cycle 22
4.7 Bowie & Dick Test 23
4.8 Helix Test 24
4.9 Vacuum Test 25
4.10 Liquid Cycle (optional) 26
5 CONTROLS AND INDICATOR AND RECORDING DEVICES ..............................................................28
6 SAFETY FEATURES ..............................................................................................................................31
6.2 Safety devices for opening and closing the door with a single control device 31
6.3 Safety valve 31
6.4 Safety Pressure Switch 31
6.5 Stop button (Fig. 2-2, Item 9) 32
6.6 Chamber pressure monitoring tap (RSC) 32
6.7 Door closing buttons (Fig. 2-2, Item 6) 32
6.8 Door closure stop device 32
6.9 Chamber pressure gauge (Fig. 2-2, Item 4 and Fig. 2-3, Item 10) 32
6.10 Jacket pressure gauge (Fig. 2-2, Item 5) 32
6.11 Generator pressure gauge(Fig. 2-2, Item 6) 32
6.12 Key to the door of the inspection section(Fig. 2-1, Item 10) 33
6.13 Switch key (Fig. 2-2, Item 7) 33
6.14 Software password 33
7 OPERATION ............................................................................................................................................34
7.2 Switching on the sterilizer 35
7.3 Switching between heating modes 36
7.4 Heating 36
7.5 Opening and closing the door 36
7.6 Loading the material for sterilizing 39
7.7 Selecting the sterilization cycle 39
7.8 Selecting the test cycle 43
7.9 Starting and running the sterilization or test cycle. 44
7.10 Unloading the material 47
7.11 Checking and filing the cycle report 47
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7.12 Performing a sterilization cycle in manual mode 49
7.13 Stopping the sterilization cycle from the terminal 50
7.14 Emergency manual operating mode 51
7.15 Sterilizer emergency stop 51
7.16 Modifying the sterilization cycle 51
7.17 Parameter Menu 52
7.18 Instruments menu 53
7.19 Switching off the sterilizer 53
7.20 Using the sterilizer 54
8 MALFUNCTIONS ....................................................................................................................................56
8.2 List of fault conditions 57
8.3 Resolution of fault conditions 59
9 CLEANING ..............................................................................................................................................62
9.1 External panels 62
9.2 Touch-screen display 62
9.3 Door gasket and cavity 62
10 MAINTENANCE.......................................................................................................................................62
11 Figures ....................................................................................................................................................63
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1 SAFETY NOTES AND PRECAUTIONS
SORDINA S.p.A. DECLINES ALL RESPONSIBILITY FOR FAILURE TO COMPLY WITH THE CONTENTS
OF THIS DOCUMENT.
THIS DOCUMENT CONTAINS SORDINA S.p.A. PROPRIETORY INFORMATION.
REPRODUCTION AND/OR DISCLOSURE TO THIRD PARTIES WITHOUT THE WRITTEN

AUTHORISATION OF SORDINA S.P.A. IS FORBIDDEN.
IN THE EVENT THAT MALFUNCTIONS WHICH IMPAIR THE MEDICAL DEVICE’S SAFETY ARE
DISCOVERED DURING USE BY THE OPERATOR AND/OR OTHER PERSONS, THE MEDICAL DEVICE
MUST BE TAKEN OUT OF SERVICE AND THE SORDINA S.p.A. CUSTOMER SERVICE DEPARTMENT
MUST BE NOTIFIED.
READ THESE INSTRUCTIONS CAREFULLY BEFORE PUTTING THE DEVICE INTO OPERATION.
THE MEDICAL DEVICE MUST ONLY BE USED BY TRAINED, AUTHORISED, RESPONSIBLE STAFF.
Commissioning, repairs and maintenance not under the jurisdiction of the authority responsible for
the medical device must only be carried out by the Sordina Technical Service or qualified technical
staff who hold a valid authorisation from Sordina S.p.A. .
Users are advised to sign a service contract with Sordina S.p.A. to ensure full compliance with the
prerequisites of European Directive 93/42/EC on medical devices.
Incorrect repairs and maintenance may put the health and safety of patients, users and even other
persons at risk.
In these instructions, the words DANGER, WARNING, and ATTENTION are used with the following
meanings:
DANGER
The word DANGER refers to a potentially hazardous situation which,
if not prevented, may cause death or serious personal injury.
WARNING
The word WARNING refers to a potentially hazardous situation which,
if not prevented, may cause minor personal injury or damage to
property.
ATTENTION
The word ATTENTION highlights important instructions or
information.
All information, illustrations and specifications in this document are based on the latest production
information available at the time of publication.
Non-genuine parts and accessories have not been examined and approved by Sordina S.p.A.. Their
conformity and safety cannot therefore be certified.
Sordina S.p.A. is not responsible for any damage caused by the use of non-genuine parts and accessories.
This document is subject to technical modifications.
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2 MACHINE DESIGNATION AND DEFINITIONS
2.1 Manufacturer
Company name : SORDINA S.p.A.

Plant : Saonara (PD), Via Emilia Romagna 9
Telephone : 049-8798101
Fax : 049-8790377
e-mail : service@sordina.com
hereinafter Sordina.
These instructions refer to the Sordina Customer Service, abbreviated below to Sordina CS.
2.2 Product
This manual provides the instructions for use of the following models:
MODELS STEAM PRODUCTION No.

Sterilizing
Chamber
Doors
S366 E Independent (electric heating) 1
S366 V External (direct steam) 1
S366 VI (heating by heat exchange) External (indirect steam) 1
S366 EV Independent (electric heating) External (direct steam) 1
S366 EVI Independent (electric heating or heat exchange) External (indirect steam) 1
S366 EP Independent (electric heating) 2
S366 VP External (direct steam) 2
S366 VIP (heating by heat exchange) External (indirect steam) 2
S366 EVP Independent (electric heating) External (direct steam) 2
S366 EVIP Independent (electric heating or heat exchange) External (indirect steam) 2
S666/9/12/15/18 E Independent (electric heating) 1
S666/9/12/15/18 V External (direct steam) 1
S666/9/12/15/18 VI (heating by heat exchange) External (indirect steam) 1
S666/9/12/15/18 EV Independent (electric heating) External (direct steam) 1
S666/9/12/15/18 EVI Independent (electric heating or heat exchange) External (indirect steam) 1
S666/9/12/15/18 EP Independent (electric heating) 2
S666/9/12/15/18 VP External (direct steam) 2
S666/9/12/15/18 VIP (heating by heat exchange) External (indirect steam) 2
S666/9/12/15/18 EVP Independent (electric heating) External (direct steam) 2
S666/9/12/15/18 EVIP Independent (electric heating or heat exchange) External (indirect steam) 2
ATTENTION
In these instructions, all models having chambers with two doors are
referred to as “PASS-THROUGH MODELS”
The model installed is identified both on the DATAPLATE  compliant with 93/42/EC and on the
DATAPLATE compliant with 97/23/EC (PED), installed inside the inspection section, on the sterilization
chamber and on the generator. (Chap. 2.6).
WARNING
The dataplates  must not be removed or defaced.
For the sake of simplicity only, this document refers, where possible, to models S36/S66 in general.
More complete model codes are used where necessary (e.g.: S66XXEV (P) refers to a standard series S66
model with electric heating and direct steam, with one or two doors).
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Please check the data on the dataplates referred to above and fill in the table below:
Manufacturing number
Serial number
Model
and specify the above data in all communications with Sordina or the Authorised Service Centre.
2.3 Operator
In this document, the term operator refers to the person or persons assigned to use the sterilizer by the
responsible authority.
It thus refers to the staff who have received sufficient training for the use of the device.
2.4 Responsible authority
In this document, the term responsible authority refers to the individual or group responsible for the use
and maintenance of the sterilizer, with responsibility for verifying that the operators have adequate training.
The responsible authority is also responsible for the conservation and use of:
 documentation as defined in Chap.2.5
 the keys to the door of the inspection compartment
 the keys to the master switch
 the software password for the modification of cycles
2.5 Documentation
The following documentation is supplied with the sterilizer:
A) Design drawing of the pressurised vessel,

B) Diagram of the door operation safety devices, AST-536, AST566
C) Safety valve certificate
D) Instructions for use MU-S36S66 (this document)
E) Technical Manual MT-S36S66
F) Electrical wiring diagram SEL S36, SEL S66
G) Water and steam system diagram SID-S36S66-X
H) Maintenance Log
I) Certificate of Conformity 93/42
J) Certificate of Conformity 97/23
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2.6 Marking
The following decals are affixed to the front surface on the loading side of the sterilizer:
DATAPLATE/DECAL POSITION
Description Figure Position Figure
Warning, hot surfaces 4-3 Loading side front surface 5-2
Warning, hand injury hazard 4-4 Loading side front surface 5-2
Warning, refer to documentation supplied 4-2 Loading side front surface 5-2
On (power supply) 4-7 Control panel 2-2
Off (power supply) 4-8 Control panel 2-2
The following decals are affixed to the front surface on the unloading side of the sterilizer (pass-through
model):
DATAPLATE/DECAL POSITION
Description Figure Position Figure
Warning, hot surfaces 4-3 Unloading side front surface 5-3
Warning, hand injury hazard 4-4 Unloading side front surface 5-3
Warning, refer to documentation supplied 4-2 Unloading side front surface 5-3
WARNING
Removing and/or defacing dataplates and symbols is forbidden.
For further information, refer to MT-S36S66, Chap. 2.6.
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3 TECHNICAL DATA
3.1 Intended use
The sterilizer is intended for sterilizing packaged materials, porous loads and non-flammable liquids in sealed
and unsealed containers using pressurised water vapour (steam).
The sterilizer is intended for use in public and private health care facilities.
The sterilizer is intended for use staff (operator) trained and authorised by the user (responsible authority).
These materials must be packaged using systems compliant with the following standards:
EN 11607-1 Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 868-2 Packaging for terminally sterilized medical devices - Sterilization wrap -
Requirements and test methods
EN 868-3 Packaging for terminally sterilized medical devices - Paper for use in the
manufacture of paper bags and in the manufacture of pouches and reels -
EN 868-4 Packaging for terminally sterilized medical devices - Paper bags -
EN 868-5 Packaging for terminally sterilized medical devices - Sealable pouches and
reels of porous and plastic film construction - Requirements and test methods
EN 868-8 Packaging for terminally sterilized medical devices - Re-usable sterilization
containers for steam sterilizers conforming to EN 285 - Requirements and test
methods
DANGER
Open or closed containers containing flammable and/or explosive
substances, for which the sterilizer is not suitable, must not be
sterilized. Materials of this kind could cause explosions with the
expulsion of fragments when the door is opened at the end of the
sterilization cycle.
Saline solution can only be sterilized with airtight containers, using
the liquid cycle.
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3.2 Classification and reference standards
The S36/S66 sterilizer is within the field of application of DIRECTIVE 93/42/EEC OF THE COUNCIL of 14
June 1993 concerning medical devices and DIRECTIVE 97/23/EEC OF THE COUNCIL concerning pressure
equipment.
Under the classification rules contained in Annex IX of Directive 93/42 (2007/47), the sterilizer is classified
as a Class IIb Device.
Under the classification rules contained in Annex II of Directive 97/23, the sterilizer assembly is classified
as stated in the table below:
Sterilizer Model Classification under Directive 97/23

S366 (P) Category II.
S66XX (P) Category III.
The S36/S66 sterilizer conforms to the following standards:
 Dossier VSR Rev.95, Ed.99 Technical specification applying the Italian Ministerial Decree dated 21
November 1972 for the stability testing of pressure equipment;
 Dossier M Technical specification applying the Italian Ministerial Decree dated 21 November 1972
concerning the construction materials of pressure equipment;
 Dossier E Technical specification applying the Italian Ministerial Decree dated 21 May 1974 –
Additions to the regulations approved by Royal Decree no. 824 dated 12 May 1927 and regulations for
the performance of a number of stability tests and checks on pressure equipment;
 UNI EN ISO 15614 Specification and qualification of welding procedures for metallic materials -
Welding procedure test;
 UNI EN ISO 15609 Specification and qualification of welding procedures for metallic materials;
 UNI EN ISO 3834 Quality requirements for fusion welding of metallic materials;
 ISO 9712 (formerly UNI EN 473) Non-destructive testing. Qualification and certification of non-
destructive testing personnel.
 UNI EN 287-1:2012 Qualification testing of welders - Fusion welding - Part 1: Steels;
 EN 285:2006+A2 (May 2009 edition) Sterilization - Steam sterilizers;
 EN 17665-1:2006 Sterilization of health care products - MOIST HEAT:
Part 1: Requirements for the development, validation and routine control of a sterilization process for
medical devices;
 EN 61010-1:2011 Safety Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use:
Part 1: General requirements;
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 EN 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and
laboratory use:
Particular requirements for sterilizers and washer-disinfectors used to treat medical materials;
 EN 61326-1:2007 Electrical Equipment for Measurement, Control, and Laboratory Use - Electromagnetic
compatibility requirements;
General regulations
 EN 14971:2009 Medical devices - Application of risk management to medical devices;
 EN 62304:2006 Medical device software - Software life cycle processes;
 EN 62366:2007 Medical devices - Application of usability engineering to medical

devices;
 EN 980:2009: Graphical symbols for use in the labelling of medical devices.
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3.3 Composition of the product
The sterilizer comprises the following main parts (Fig. 2-1):
Pressure vessel
This is the vessel which contains the pressurised steam and comprises the following components:
 Sterilization chamber (chamber) (Item) 1): the part of the vessel which receives the load for sterilization. It
has one door or two doors (pass-through sterilizer) for loading and unloading of the material.
 Jacket: the part of the vessel which surrounds the sterilization chamber. Its function is to heat the wall of
the sterilization chamber. It is used to receive the steam produced in the steam generator inside the
device (sterilizer with independent steam production - models E, EV, VI and EVI ) or to receive the steam
produced externally (direct steam sterilizer - models V). In all cases, its function is to heat the walls of the
chamber and to transfer the steam used for the sterilization process to it.
 Generator (Item 14): two types of generator, installed outside the jacket, may be used for steam
production. An electric steam generator, fitted with several heating elements in direct contact with the
water, which produce steam; or a heat exchange steam generator installed when steam is to be produced
with the aid of customer-supplied steam, which however is not suitable for direct use for the sterilization
process. This steam, at 6-7 bar, passes through coils submerged in the water in the generator. The
generator may be equipped with electric heating elements for emergency operation.
 Chamber door (door) (Item 2): cover or similar device used to close the chamber and ensure that it is
pressure-tight.
 Door fixtures and/or runners: devices used to guide the door during its opening and closing motion and to
anchor it to the chamber
The door is rendered pressure-tight by a silicone rubber gasket (Item 3) fitted into a cavity on the end flange
of the chamber.
The gasket is pressed against the door by the steam taken directly from the device’s jacket.
The sterilization chamber is fitted with the following unions for validation and monitoring procedures:
 G ½ union (Item 4) for connection of pressure measurement instruments
 G 1 union (Item 5) for the insertion of temperature probes
The top edge of the door or the side edge is fitted with a mobile rib device (Item 6) which stops closure of the
door if an obstruction is encountered.
pressure vessel is constructed entirely in austenitic stainless steel.
Frame and panels

This is the sterilizer’s supporting and enclosing system and comprises:
 supporting frame (Item 7)
 inspection section (Item 8)
 inspection section door (Item 9)
 panels (Item 11)
Water and steam system

The system used for the distribution, shut-off, regulation and drain of the fluids (water, air, steam and
condensation) used and/or produced during performance of the sterilization process.
Electrical system
The electromechanical components used to operate the water/steam system, mechanical and electrical
(valves, pumps, motor, electric heating elements) components in response to commands from the control
system and/or use of manual controls by the operator
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Instrumentation
The combination of analogue and digital instruments used to inform the control system and/or operator of the
sterilizer’s operating status.
Control system
The hardware and software system used for operation of the sterilizer and for automatic performance of the
sterilization cycles.
Recording system
The hardware and software system used to record the values of the sterilization cycle parameters (time,
temperature and pressure) which are stored on paper or as an alternative in digital format on SD or MMC
memory media by means of a data logger. It operates independently of the control system.
Control panel
The panel on the front of the sterilizer (Item 13), which is the operator interface for operation of the sterilizer.
It comprises (Fig. 2-2):

 graphic touch screen (Item 1)
 printer (Item 3)
 chamber vacuum gauge (Item 4)
 jacket pressure gauge (Item 5)
 generator pressure gauge (Item 6)
 key-switch (Item 7)
 stop device (Item 2)
Control panel (pass-through model)

The panel on the front of the sterilizer, on the unloading side (Item 13).
It is the operator interface for control of the sterilizer.
It comprises (Fig. 2-3):

 graphic touch screen (Item 8)
 chamber vacuum gauge (Item 10)
 stop button (Item 9)
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3.4 Load stowing accessories
These are stainless steel containers used for placing the load for sterilization inside the sterilization chamber.
They are of the following types:
 Stainless steel baskets
Description Code Model Application

Stainless steel wire baskets
900500001 C-80 S666-S669-S6612
Dim. 590x280x135 mm
900500002 C-81 S666-S669-S6612
Dim. 590x280x255 mm
900500003 C-82 S666-S669-S6612
Dim. 280x280x255 mm
900500004 C-83 S666-S669-S6612
Dim. 280x280x135
 Containers
Description Code Model

“Filter” model container with soft anodization
with two filters, without hinge 900500020 2020
Dim. 600x300x260 mm
“Filter” model mini container with two filters, without hinge
900500025 2052
Dim. 265x170x160 mm
“Filter” model mini container with two filters, without hinge
900500030 2053
Dim. 265x170x200 mm
Racks
Racks with shelves to support the load inside the sterilization chamber may be of fixed or movable type.
Fixed racks have feet while movable racks are on wheels. However, even fixed racks can be removed from
the chamber for routine cleaning of the sterilization chamber.
Racks are in AISI 304 stainless steel and feet are in high-temperature PTFE.
 Fixed racks

S366 loading rack with sterilizer-resistant feet 896001020 GA-F S366 S366 - S366P
 Movable racks

S366 loading rack with sterilizer-resistant wheels 896001021 GA-M S366 S366 - S366P
S6612 loading rack with sterilizer-resistant 896001026 GA-M S6612 S6612 – S6612P
wheels
S6615 loading rack with sterilizer-resistant 896001027 GA-M S6615 S6615P
wheels
S6618 loading rack with sterilizer-resistant 896001028 GA-M S6618 S6618P
wheels
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3.5 Chamber accessories
These are fixed shelves fitted inside the chamber to receive material not loaded in racks, to prevent direct
contact between the stainless steel baskets and/or containers and the very hot surface of the chamber.
 Fixed shelf

Fixed grille shelf for S366 900219895 PFG S366 S366
3.6 Load handling accessories
These are sterilizer loading/unloading trolleys with AISI 304 stainless steel supporting structure, for handling
loads in the packaging and storage rooms. They are fitted with two runners for loading/unloading the
movable racks inside the sterilization chamber and antistatic castor wheels, two of them with brakes.
They are of the following types:
 Manual, fixed height

S366 sterilizer loading/unloading trolley 900219991 CA S366 S366 - S366P
S6612 sterilizer loading/unloading trolley 900219994 CA S6612 S6612 – S6612P
 Electric, adjustable height

S366 sterilizer loading/unloading trolley with electric 900219996 CA-E S366 S666 - S666P
raising/lowering system
S669 sterilizer loading/unloading trolley with electric 900219999 CA-E S6612 S6612 – S6612P
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4 STERLIZATION AND TESTING CYCLES
4.1 General information
The sterilization is supplied with the following sterilization and testing cycles:
POROUS LOAD : intended for sterilizing porous loads and packaged products at 134°C
RUBBER LOAD : intended for sterilizing rubber loads at 121°C
METAL LOAD : intended for sterilizing packaged metal loads
CONTAINER LOAD : intended for sterilizing instruments packed into containers
LIQUID CYCLE : intended for sterilizing liquids in containers (optional)
Bowie & Dick Test : intended to check the removal of air from porous loads
Helix Test : intended to check the penetration of steam into hollow items
Vacuum Test : intended to check the vacuum-tightness of the sterilization chamber
The control system also allows a further 11 different sterilization cycles to be set (see MT-S36S66, Chap. 7).
WARNING
Before starting to use the appliance for sterilizing medical devices,
once installation is complete the cycles and loads must be validated
in accordance with EN17665.
WARNING
If the parameter values or phase sequence are modified or a new
sterilization cycle is set, the cycle must be revalidated before it is
used for sterilizing medical devices
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4.2 Sterilization cycle phases
Pressure
9 10
6-7 6- 7 (x 2) 6 – 7 (x n)
Phase 1 -2 -3 12 14-15-16
t
13
4 5 8 (x n) 11
8 8 (x2)
Continuous or pulsed
drying with n phases
This chapter provides a detailed description of the phases in a typical sterilization cycle.
PHASE DESCRIPTION
1 Cycle start
2 Door locking (phase not displayed or recorded)
The door of the sterilization chamber is locked to prevent it from moving vertically (for S66
sterilizers) or horizontally (for S36 models) throughout the cycle
3 Gasket filling (phase not displayed or recorded)
The gasket channel is filled with steam to provide an airtight seal around the door.
4 Initial vacuum in sterilization chamber
A vacuum is generated in the sterilization chamber until the set value is reached
5 Additional vacuum
The creation of the vacuum in the sterilization chamber is prolonged for the time set
6 Steam injection
Steam is injected into the chamber with the outlet closed until the set injection pressure value is
reached
7 Additional injection
The delivery of steam to the chamber is stopped. This phase lasts for the additional injection time
8 Stepped Vacuum
9 Sterilization injection
Steam is injected into the chamber with the outlet closed until the set sterilization temperature is
reached
10 Sterilization
The sterilization phase starts when the sterilization temperature set for the current cycle is reached.
This phase lasts for the sterilization time set.
The pressure in the sterilization chamber is maintained at a level that keeps the temperature
measured in the chamber within the sterilization temperature band
11 Drying vacuum
12 Drying
The vacuum is maintained for the drying time set
13 Air intake
Filtered external air is drawn into the chamber until atmospheric pressure is reached
14 Gasket discharged (phase not displayed or recorded)
Steam is discharged from the gasket channel to remove the airtight seal around the door
15 Door unlocking (phase not displayed or recorded)
The door of the sterilization chamber is unlocked to allow it to move up and down.
16 End of cycle
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4.3 POROUS LOAD Cycle
Application:
Sterilization of porous loads at 134°C
Maximum load per Sterilization Unit:
Type of load Weight [kg]

Packed laundry (including basket) 8
Phase sequence and parameter values:
PHASE PARAMETER VALUE

Initial vacuum Pressure (mbar) 100
Additional vacuum time (min:sec) 02:00
Heating - Stepped Vacuum Phase sequence no. 3
Vacuum Point Pressure (mbar) 130
Injection Point Pressure (mbar) 1500 / 2000
Sterilization injection Temperature (°C) 135.0
Sterilization 134 °C Time (min:sec) 05:30
Drying vacuum Pressure (mbar) 150
Continuous drying time (min:sec) 06:00
The pressure values stated are expressed in absolute mbar. (1013 at atmospheric pressure at sea level)
Sterilization cycle duration with full load (min) 50 ÷ 80
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4.4 RUBBER LOAD cycle
Application:
Sterilization of packaged rubber articles at 121°C
ATTENTION
Make sure that the material for processing is suitable for steam
sterilization and that its chemical, physical and functional
characteristics will not be impaired by prolonged exposure to
temperatures within the sterilization temperature band.

Packed rubber articles (including basket) 3.5

Additional vacuum Time (min:sec) 02:00
Drying Time (min:sec) 06:00
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4.5 METAL LOAD cycle
Application:
Sterilization of instruments packed in reusable containers in bags, inside baskets.

Instruments in containers (including container) 15
Instruments in bags (including basket) 15

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4.6 CONTAINER LOAD cycle
Application:
Sterilization of instruments packed in reusable containers in bags, inside baskets.

Instruments in containers (including container) 15
Instruments in bags (including basket) 15

Pulsed drying Number of pulses 7
(Pa) (maximum pressure of each 400
peak) (mbar)
(Pb) (minimum pressure of each 120
peak) (mbar)
Drying Time after pulse phase (s) 600
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4.7 Bowie & Dick Test
The Bowie & Dick Test is designed to check the efficacy of the removal of air from porous loads.
ATTENTION
Test cycle
Do not use this cycle to sterilize material
If the Bowie & Dick Test test is passed, steam is penetrating the test pack quickly and evenly, as required by
EN17665 and EN285.
A failed Bowie & Dick Test may be due to:

 ineffective air removal
 leaks during air removal
 non-condensible gases in the steam
The sterilizer therefore has a specific cycle for automatic performance of the Bowie & Dick Test. This cycle
automatically comprises the same sequence of phases and the same parameter settings as the other cycles,
with the sole difference that the sterilization phase comprises:
B.&D. Sterilization. Test [°C] Temperature [°C] 135.0

time (min:sec) 3:30
ATTENTION
The sterilizer is designed to use the standard test pack described in
Chap. 24.1 of EN 285.
The user may use simulators or test packs with different materials,
dimensions and weights provided their equivalence to the standard
pack is documented.
ATTENTION
The chemical indicator must be compliant with the EN 867-3 standard.
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4.8 Helix Test
The Helix Test is designed to to assess the penetration of steam into hollow items.
ATTENTION
Test cycle
Do not use this cycle to sterilize material
A pass result from the Helix Test proves that steam penetrates evenly into the PCD (Process Challenge
Device).
A failed Helix Test may be due to:

 ineffective air removal
 leaks during air removal
 non-condensible gases in the steam
The sterilizer therefore has a specific cycle for automatic performance of the Helix Test. This cycle
automatically comprises the same sequence of phases and the same parameter settings as the sterilization
cycles with the sole difference that the sterilization phase, which involves a temperature setting of 134°C for
a time of 3.5 minutes. :
Helix Test Sterilization [°C] Temperature [°C] 135.0

time (min:sec) 3:30
ATTENTION
The PCD and the chemical indicator must be compliant with the EN
867-5 standard.
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4.9 Vacuum Test
The Vacuum Test is designed to check that:

 the air entering the sterilization chamber during the vacuum phases does not prevent the steam from
penetrating the load
 the air which enters during the during phase does not generate a risk of recontamination of the load
The sterilizer therefore has a specific cycle for automatic performance of the Vacuum Test. This cycle
comprises the following sequence of phases:
Pressure
1-2-3 13-14-15
t
12
300 s 600 s
4
5 6 8 10
PHASE DESCRIPTION
1 Cycle start
2 Door locking (phase displayed but not recorded)
The door of the sterilization chamber is locked to prevent it from moving vertically throughout
the cycle
3 Gasket filling (phase displayed but not recorded)
The gasket channel is filled with steam to provide an airtight seal around the door.
4 Initial vacuum
5 Additional vacuum
The creation of the vacuum in the sterilization chamber is prolonged for the time set
6 Recording
The time T1 and pressure inside the chamber P1 are recorded
7 Conditioning
A fixed time of 300 seconds is counted
8 Recording
9 Test
A fixed testing time of 10 minutes is counted
10 Recording
11 Check
The system checks that (P3-P2)/(T3-T2)  1.3 mbar/min
12 Air intake
Filtered external air is drawn into the chamber until atmospheric pressure is reached
13 Gasket discharge (phase displayed but not recorded)
Steam is discharged from the gasket channel to remove the airtight seal around the door
14 Door unlocking (phase displayed but not recorded)
The door of the sterilization chamber is unlocked to allow it to move up and down.
15 End of cycle
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The table below shows the values of the parameters:

Initial vacuum pressure (mbar) 70
Additional vacuum time (min:sec) 01:00
Conditioning time (min:sec) 05:00
Test time (min:sec) 10:00
In the case of a negative outcome from the Vacuum Test, the test should be performed a second time. If the
problem persists, contact the Sordina Customer Service to have the sterilizer inspected for leaks or
malfunctions.
4.10 Liquid Cycle (optional)
Application:
Sterilization of liquids in sealed and unsealed containers.
Pressure
2
1 3
PHASE DESCRIPTION
1 Steam injection
Steam is gradually injected into the chamber until the set pressure and temperature values are
reached
2 Sterilization
The sterilization phase starts when the sterilization temperature is reached inside the control
container.
This phase lasts for the sterilization time set.
The pressure in the sterilization chamber is maintained at a level that keeps the temperature
measured in the chamber within the sterilization temperature band
3 Pressure discharge
The pressure is slowly, gradually discharged until the set cooling temperature is reached inside the
control container.

Liquid in containers 15
WARNING
The liquid must be in specific containers which are fit for this
purpose
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If unsealed containers are used, the steam comes into direct contact with the liquid for sterilizing. During the
sterilization cycle, the steam transfers its latent heat to the walls of the vessel, which transmit it to the liquid
inside. Above all, the container must withstand the sterilization temperature set.
The Liquid Cycle has a standard temperature setting of 121°C for a time of 1800 seconds.
The operator may modify the temperature and duration parameters of the sterilization phase once the level 2
password has been entered (see point 7.8).
The sterilization temperature may be set between 105 and 134 °C.
Unlike surgical instruments, liquids take longer to reach sterilization temperature than non-liquid materials.
With the standard sterilization parameters and the sterilizer fully loaded, using 1 litre containers the duration
of the sterilization cycle is less than 120 minutes.
Sordina sterilizers are equipped with a second, flexible temperature probe placed in a control container filled
with the liquid for sterilizing, which ensures that the sterilization temperature set has actually been reached
when sterilization starts. Sterilization does not start until the probe reaches the set temperature threshold.
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5 CONTROLS AND INDICATOR AND RECORDING DEVICES
These are all those devices used by the operator during normal operation of the sterilizer to:
 switch the sterilizer on and off
 select and perform the sterilization and test cycles
 open and close the door of the sterilization chamber
 display the sterilizer’s status, the pressure and temperature inside the chamber and the pressure in the
jacket
 display and record the progress of the sterilization cycle
 display and record malfunctions
The following are installed on the front surface of the sterilizer (see Fig. 2-1):
Control panel (Item 13) comprising (see Fig. 2-2):
 graphic touch screen (Item 1)

This is a 5.7”, 320x240 pixel LCD STN graphic touch-screen terminal.
It is used for:
 opening/closing the door of the sterilization chamber on the loading side (non-sterile side)
 selecting a sterilization or test cycle
 starting or stopping a program
and for indicating:
 the pressure in the sterilization chamber, expressed in both relative bar (atmospheric pressure = 0 bar)
and absolute bar;
 the pressure in the jacket, expressed in both relative bar (atmospheric pressure = 0 bar) and absolute
bar;
 the temperature inside the sterilization chamber (measured on the active outlet);
 the temperature and pressure measured in the sterilization chamber by the recording system, expressed
in °C and absolute bar;
 the sterilizer’s operating modes;
 the status (open or closed) of the sterilization chamber doors;
 the name of the current phase and the time remaining until its completion;
 the menus for displaying and modifying sterilization cycles, phases and parameters;
 the menus for setting the offset and range parameters of the measuring system;
 indications of malfunctions;
 the status of the inputs and outputs.
The following is an example of a display screen:
P.i = jacket pressure (absolute)

T = chamber control temperature
P.c = chamber pressure (absolute)
P.i.r. = jacket pressure (relative)
P.c.r. P.c = chamber pressure (relative)
Door Status Number of cycles

on non-sterile Alarm performed
side indication
Screen Automatic Flashes if automatic
Door Status
number
on sterile side cycle switch-off or start is
active
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 printer(Item 3)
This is an alphanumeric and graphic thermal printer able to print 40 characters per line.
It operates on the RS 232 serial communications standard.
It is used to provide a permanent, conservable record, independent from the control system, of the following
data:
 device serial number;
 sterilization or test cycle identification;
 consecutive number of the program;
 date;
 cycle start time;
 identity of the operator who started the cycle
 name of sterilization process phases;
 temperature, pressure and time of each phase.
 outcome of the cycle
It is also used to record:

 the performance of non-valid sterilization programs;
 the outcome of the Vacuum Test;
 identification of malfunctions.
WARNING
The thermal paper must not be exposed to direct light, heat or damp.
For a longer conservation lifetime, reports must be kept in dark envelopes in dry places.
 chamber vacuum gauge (Item 4)

This is an analogue device which provides a continuous reading, independently from the display reading, of
the value of the pressure inside the sterilization chamber, expressed in relative bar.
The pressure reading must not exceed 2.3 bar
 jacket pressure gauge(Item 5)

This is an analogue device which provides a continuous reading, independently from the display reading, of
the value of the pressure inside the jacket, expressed in relative bar.
 generator pressure gauge(Item 6)

This is an analogue device which provides a continuous reading of the value of the pressure inside the
generator, expressed in relative bar.
 Key-switch (Item 7)
Key-switch used to switch the sterilizer on and off and to restore operation after the stop button has been
pressed.
 stop button (Item 9)

Mushroom-head button with manual reset used to stop the sterilizer.
Optional
 Datalogger for digital recording of sterilization cycles.
The data are stored on an SD or MMC memory card and then imported to a PC, after which all the
cycle information is displayed, printed and stored in a file database by means of a specific software
program.
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The control panel is installed on the front of the sterilizer on the unloading side (pass-through
model). It comprises (see Fig. 2-3):
 graphic touch screen (Item 8)

This is a 3.8”, 320x240 pixel LCD STN graphic touch-screen terminal.
It is used for:
opening and closing the sterilization chamber door on the unloading side by means of two touch-type buttons
and for indicating:

 the pressure in the sterilization chamber, expressed in both relative bar (atmospheric pressure = 0 bar)
and absolute bar;
 the pressure in the jacket, expressed in both relative bar (atmospheric pressure = 0 bar) and absolute
bar;
 the temperature inside the sterilization chamber expressed in °C;
 the sterilizer’s operating modes;
 the status (open or closed) of the sterilization chamber doors;
 the name of the current phase and the time remaining until its completion;
 indications of malfunctions.
 chamber vacuum gauge (Item 10)

Refer to the description provided above.
 stop button (Item 9)

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6 SAFETY FEATURES
This chapter describes the safety devices which are tripped automatically or which may be activated by the
operator.
DANGER
If safety devices are presumed to be or are actually defective, take the
sterilizer out of use and notify the Sordina Customer Service.
Some of the devices listed below have already been described. However, they are referred to here in order
to highlight their safety characteristics.
6.2 Safety devices for opening and closing the door with a single control device
The door opening and closing safety devices are constructed in accordance with the technical standards
currently in force in Italy:
European Directive 97/23/EC, DOSSIER E , Chapter E.4.A.4.
These devices:
 prevent the supply of steam to the sterilization chamber or the gasket channel with the door open or not
properly closed
 prevent opening of the door with the chamber pressurised
To ensure this compliance, a design based on the AST-536 guideline diagram, applicable for both single
door and two-door models, has been created.
For instructions on regular checking of their operation, refer to MT-S36S66, Chap. 11.2.3.
6.3 Safety valve
This valve is installed on the steam generator and is used to vent the steam if the pressure exceeds the
value calibration value (3.5 bar), which is also the design pressure of the pressure vessel.
It is supplied complete with its manufacturer’s test certificate. This certificate is provided with the
documentation supplied with the sterilizer.
For instructions on regular checking of the valve’s operation, refer to MT-S36S66, Chap. 11.2.6.
6.4 Safety Pressure Switch
This device is installed on the steam generator and is used to cut off the electricity supply to the steam
production system and activate an alarm buzzer if the pressure exceeds the pressure switch setting value
(3.4 bar).
It is calibrated at the stated pressure using a primary instrument with Accredia certification during in-
production testing
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6.5 Stop button (Fig. 2-2, Item 9)
It must also be used in case of present or imminent danger arising from operation of the sterilizer (see also
Chap. 7.15).
It is operated by pressing down the red mushroom. It is reset by turning the red mushroom clockwise.
6.6 Chamber pressure monitoring tap (RSC)
This device is used to check the pressure inside the sterilization chamber as required by the A.N.C.C.
Dossier E , Folder E.4, Chapter E.4.A.4.
Any steam vented from the chamber is discharged into the equipment section of the appliance.
6.7 Door closing buttons (Fig. 2-2, Item 6)
These are on the touch-screen and are enabled for operation directly by the microprocessor only when all
safety conditions are met.
When the closing button is released, movement of the door stops.
For instructions on regular checking of the device’s operation, refer to MT-S36S66, Chap. 11.2.2.
6.8 Door closure stop device
The top edge of the door(S66 series) or the side edge (S36 series) is fitted with a mobile rib device (Item 2-1,
Item 6) which stops closure of the door if an obstruction is encountered.
This device is tripped if the force applied by the obstruction is 4 kg or more.
For instructions on regular checking of the device’s operation, refer to MT-S36S66, Chap. 11.2.16.
6.9 Chamber pressure gauge (Fig. 2-2, Item 4 and Fig. 2-3, Item 10)
This is classified as a safety device because it allows:

 checking of the pressure value in the chamber shown on the display during normal operation;
 checking that the pressure in the chamber has been returned to normal at the end of the cycle;
 indication of the pressure value inside the chamber in the event of a failure of the control system and/or
the pressure measuring circuit
6.10 Jacket pressure gauge (Fig. 2-2, Item 5)

 checking of the pressure value in the jacket shown on the display during normal operation;
 indication of the pressure value inside the jacket in the event of a failure of the control system and/or the
pressure measuring circuit
6.11 Generator pressure gauge(Fig. 2-2, Item 6)

 checking of the pressure value in the steam generator shown on the display during normal operation;
 indication of the pressure value inside the generator in the event of a failure of the control system and/or
the pressure measuring circuit
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6.12 Key to the door of the inspection section(Fig. 2-1, Item 10)
This is classified as a safety device because it allows the door of the sterilizer’s inspection section to be
locked, preventing the operator from accessing it, during normal use.
WARNING
During normal operation, the door of the inspection section must
always be locked.
The key must be kept and used by the responsible authority.
6.13 Switch key (Fig. 2-2, Item 7)
This is classified as a safety devices because it must be used to switch on the sterilizer and after the stop
button has been pressed.
WARNING
6.14 Software password
This is classified as a safety device because its use is essential for access to the menus for modifying
sterilization cycles, phases and parameters.
WARNING
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7 OPERATION
This chapter describes the procedures to be followed by the operator during normal use of the sterilizer.
DANGER
If one or more of the following occur during the sterilizer cycle or with
the sterilizer in standby:
 phase or cycle time count or clock stops

 phase continues for longer than the normal time
 display malfunction or failure
 phase recording malfunction or failure
the sterilizer’s control system must be considered to have failed.

Therefore, stop the sterilizer by pressing the stop button and notify
the Sordina Customer Service.
DANGER
If the safety valve vents with the sterilizer cycle in progress or with
the sterilizer in standby, stop the appliance by pressing the stop
button and notify the Sordina Customer Service.
ATTENTION
The values of the parameters on the screen-shots in this chapter are
purely guideline.
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7.2 Switching on the sterilizer
WARNING
The sterilizer must always be switched on by the responsible
authority.
Proceed as follows:
A) turn on the stop devices installed by the user on the fluid supply pipes outside the sterilizer equipment
section;
B) check that the pressure readings of the pressure gauges are as stated in the installation specifications in
MT-S36S66 Chap. 3.7)
ATTENTION
Do not switch on the sterilizer if the fluid pressures are not as stated
in MT-S36S66.
Turn off the stop devices and deal with the cause of the malfunction.
C) turn on the master switch installed by the user;

D) reset the stop button (Fig. 2-2, Item 2 and Fig. 2-3, Item 9);
E) fit the key into the switch (Fig. 2-2, Item 7)
F) turn the key clockwise to I (run)
G) release the key (the key turns back to 0 (stop))
H) remove the key.
When the sterilizer is switched on, the Sordina logo appears on the display while the software is loading.
When the program has loaded, the main menu page (page 1) appears. The sterilizer starts to take in water
and the generator starts to heat up.
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7.3 Switching between heating modes
Follow the procedure described in MT-S36S66, Chap.6.
7.4 Heating
Once the generator has heated up, the message Generatore pronto (Generator ready) appears on the
display. Sterilizer cycles are now possible.
7.5 Opening and closing the door

The sterilization chamber door is opened and closed using the “APRI P1” (OPEN) and “CHIUDI P1”
(CLOSE) touch buttons. P1 refers to the loading door on the non-sterile side.
Icons “Porta1 (Door 1)” and “Porta 2

(Door 2)”
indicate the status (open or closed) of the
loading and unloading doors (pass-through
models).
LOADING door operating buttons
7.5.1 General information
doors of series S66 models

move vertically. Doors are pneumatically operated, by one cylinder (in S36 models) or two cylinders (in S66
models).
A) the door is closed by holding down the close button on the touch-screen;
B) to close the door completely, the button must be held down until the door comes to an automatic stop;
C) When the closing button is released, movement of the door stops immediately;
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D) the door is opened by pressing the open button on the touch-screen;
E) to stop the door opening movement, press the door closing button “CHIUDI P1”
WARNING
The door must be opened and closed by just one operator.
WARNING
Before starting to close the door, check that the material for
sterilizing is not in its path.
WARNING
There must be no other persons in the vicinity of the chamber door
when it is opened or closed.
If a hazard occurs, stop movement of the door at once.
If the mobile rib device is tripped, remove the obstruction which

tripped it before starting to close the door again.
DANGER
Opening the door gives access to the sterilization chamber, which is
very hot. Take care not to touch the walls of the chamber and use
suitable protection if necessary.
7.5.2 Special instructions for the pass-through model
ATTENTION
The instructions provided in 7.5.1 also apply to the door on the
unloading side for the pass-through model.
The unloading side door is opened and closed using the “APRI P2” (OPEN) and “CHIUDI P2” (CLOSE)
touch buttons on the unloading side touch-screen.
“P2” identifies the sterilization chamber door on the non-sterile side.
Sterile Side Touch Screen Terminal
UNLOADING door operating buttons
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In the pass-through model, both of the sterilization chamber doors cannot be opened simultaneously. The
loading side door cannot be opened/closed unless the unloading side door is correctly closed, and vice-
versa for the door on the unloading side.
Once a sterilization cycle has been successfully concluded, the display shows “FINE (END)” to indicate that
the cycle has finished, and only the unloading door can be opened.
The unloading door cannot be opened if a test cycle, such as the Bowie & Dick or Vacuum Test, has been
performed.
Therefore (see Fig. 2-3):

 if both doors, “Porta 1” and “Porta 2”, are closed: the loading door or the unloading door can be opened
when a sterilization cycle has been completed;
 if the loading side door is closed and the unloading side door is open: only the unloading side door can
be opened/closed (however, once it has been opened and then closed it will not be possible to reopen it)
 if the unloading side door is closed and the unloading side door is open: only the loading side door can
be opened/closed.
WARNING
In the event of malfunction of either or both the two Touch-screen
indications (Porta 1 chiusa/aperta, Porta 2 chiusa/aperta - meaning
Door 1 closed/open, Door 2 closed/open) , take the sterilizer out of
operation and notify the Sordina Customer Service.
ATTENTION
At the end of a valid cycle, only the door on the unloading side can be
opened.
At the end of a non.valid cycle, only the door on the loading side can
be opened.
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7.6 Loading the material for sterilizing
The load for sterilizing must comply with the instructions provided in Chap. 4 in terms of:
 sterilization cycle
 packaging system
 weight per Sterilization Unit
WARNING
Do not exceed the weights stated in Chap. 4.
Do not place material not gathered together in baskets or containers
inside the chamber.
The load must be tidily arranged inside the chamber, on the shelves provided.
WARNING
Do not place load supporting devices other than those supplied with
the sterilizer inside the chamber.
WARNING
The high temperature inside the sterilization chamber may cause
burns.
Use suitable protection systems for the hands and arms.
Partial loads must be arranged so that the bottom shelf is filled first.
After loading, check that there are no objects in the path of the sterilization chamber door.
In pass-through models, check that the load is not against the door on the unloading side.
7.7 Selecting the sterilization cycle
Press the Sterilizz. button on the Main Menu screen (page 33) to obtain the list of programs available:
4 = Porous load
5 = Metal load
6 = Rubber load
7 = Container load
8 = Liquid Cycle (optional)
The button on the left of each program is used to select the cycle required.
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Press to move around the list of sterilization programs.
For example, selecting Carico Container (Container Load) accesses the following screen
START = cycle start (only if the door has been

opened then closed and the generator is ready)
MODIFICA (MODIFY)= gives access to the screen

with the parameters of the cycle concerned (with
level 3 password)
See MT-S36S66 chap. 8.5
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7.7.1 Liquid Cycle (Optional)
In the liquid cycle program menu:
Press the button on the left to access the LIQUID CYCLE program
and the following screen will appear:
7.7.1.1 Cycle Start
Press START to start the program; before pressing start, press the ACK button
See points 7.9, 7.10, 7.11, 7.12, 7.13 for instructions for control of the sterilizer’s operating cycle.
WARNING
The sterilizer is fitted with a second flexible probe, used to monitor
the temperature in the chamber in the standard setup. Before giving
the program Start command, the second probe must be placed inside
a control container of the liquid for sterilizing.
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7.7.1.2 Liquid Program Cycle End
At the end of the sterilization cycle, before starting the next cycle the RE ON button must be pressed to start
heating of the sterilizer jacket.
7.7.1.3 Modifying the sterilization parameters: temperature and duration
Press MODIFICA (MODIFY) and type the level 2 password (operator password) to set
the sterilization temperature and time.
Tster = sterilization temperature

Time = time in seconds
For example, press the 121 button and the 1800 button to modify the value set.
DANGER
The sterilization process must have a proven lethality such that the
theoretical probability of the presence of a viable micro-organism is
-6
less than or equal to 1 x 10 .
The Lethality Factor - F0 is calculated using the sterilization time and
temperature by means of this formula:
F0= Time X 10 (Tster-121)/10

A recognised sterilization cycle at 121°C has a dwell time of at least
18 minutes (1080 seconds and provides a theoretical probability of
-6
the presence of a viable micro-organism less than or equal to 1 x 10 .
Any changes to the set sterilization time and temperature must
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guarantee a result at least as good as or better than this.
7.8 Selecting the test cycle
Press the Test button on the Main Menu screen to obtain the list of programs available:
1 = Heating
2 = Vacuum Test
3 = Bowie & Dick Test / Helix Test
The button on the left of each program is used to select the program required.
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7.9 Starting and running the sterilization or test cycle.
7.9.1 General information
Once a cycle has been selected, the Start button can be pressed to run it. If the relative Operator enabling
option (MT-S36S66 chap. 8) has been selected during the setup, the password input page appears; the
operator must type his password. In this case, the operator code will also be printed on the printer at the start
of each cycle.
If the sterilization or test cycle is started with the sterilization chamber door open, the display shows the
warning:
PORTE APERTE (DOORS OPEN)
Close the door and press START again.
The sterilization or test cycle can only be started if the display shows:
GENERATORE PRONTO (GENERATOR READY)
The control system is designed to perform the sterilization and test cycles automatically.
After the cycle is started, the system performs the fixed sequence of phases described in Chap. 4, in
accordance with the parameter values set.
The following is an example of a display screen:
Sterilizer commands:
STOP = immediate, irreversible cycle stop
MAN = switch to manual mode. When this button is pressed, the START button is displayed.
START = each pressure on this button moves the cycle forward one phase.
TREND = gives access to the screen with the pressure and temperature trends (runtime graphs)
Cycle time = time since cycle start, in minutes and seconds.

Phase time = time passed in each phase, in minutes and seconds.
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Pressing the “TREND” button on the right accesses the graphic display screen where the temperature and
pressure values measured by the recording system can also be displayed.
Jacket pressure
Control
temperature Control
pressure
Recording
pressure
Phase time Recording

temperature
Pressure and temperature

trend graph
Press to go back to the previous page.
At each change in phase, the printer records the phase name, the temperature and pressure in the chamber
and the time since the start of the cycle.
When the cycle ends, the buzzer sounds in on/off mode and the valid cycle message appears at the bottom
of the Main Menu screen:
ATTENTION
At the end of the sterilization cycle, the printer report must be
checked to ensure that the sterilization cycle was valid and has taken
place correctly, in accordance with the phase sequence and
parameter values set.
ATTENTION
To select and start a new cycle, the sterilization chamber door must
be opened and then closed again.
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7.9.2 Special instructions for the pass-through model
When the sterilization cycle starts, the word CICLO (CYCLE) lights up on the sterile side display. This word
continues to be lit up throughout the cycle.
At the end of a valid cycle, CYCLE disappears and

FINE (END) illuminates: the door on the unloading
side can be opened.
At the end of a non-valid cycle, CYCLE disappears and

FINE (END) and ALLARME (ALARM) illuminate: only
the door on the loading side can be opened.
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7.10 Unloading the material
Completely unload the sterilization chamber, proceeding methodically starting with the top shelf and the most
accessible material.
WARNING
The high temperature inside the sterilization chamber may cause
burns.
Use suitable protection systems for the hands and arms.
WARNING
Incorrect and/or hurried unloading may cause material to be dropped,
with the risk of injury and damage to property.
7.11 Checking and filing the cycle report
At the end of the cycle, the report must be checked before the load is issued for use.
WARNING
The cycle report must be checked and filed by the responsible
authority.
The following must be checked:

 that the printer has produced a complete report on the cycle;
 that no malfunctions have been recorded,
 that the report correctly states the data of the chosen cycle, the cycle number and the starting date and
time;
 that the sequences of phases referred to in 4.2 has been recorded, with the pressure, temperature and
time values for each phase;
 the end-of-cycle check (CYCLE CHECK) concludes with VALID CYCLE
The following is an example of a CYCLE CHECK for a valid cycle:
-------- CYCLE CHECK ----------

STERIL. TEMP. SET = 134.0 °C
MIN. STERIL. TEMP. MEASURED

134.9 °C (2.124 bar)

135.5 °C (2.137 bar)
MIN. TEMP. IN TOLERANCE RANGE
CYCLE VALID
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The following is an example of a CYCLE CHECK for a non-valid cycle:
-------- CYCLE CHECK ----------

MIN. TEMP. SET = 134.0 °C

133.9 °C (2.004 bar)

135.5 °C (2.137 bar)
MIN. TEMP. OUTSIDE TOLERANCE RANGE
CYCLE NOT VALID
DANGER
If the report check gives a negative outcome and in particular if the
CYCLE IS NOT VALID, the material must not be issued for use.
In all cases, the report must be filed for future reference.
WARNING
In order to extend the conservation lifetime of the printouts, they
should be kept in sealed dark envelopes in a dry place, away from
direct light sources.
A digital recording system comprising a Datalogger which records on SD memory media to allow the data to
be transferred and stored in a file database is also available.
MU-S36S66-E-ED1R0 48 / 79
7.12 Performing a sterilization cycle in manual mode
The sterilization cycle is performed in manual mode when the user wants to complete the various phases of
the cycle quickly without waiting for them to take place automatically.
To perform a cycle that has already started in manual mode, press the MAN button on the cycle page
Sterilizer commands:
MAN = switch cycle to manual mode. When this button is pressed, the START button is displayed.
START = each pressure on this button moves the cycle forward one phase.
This operation switches the cycle to manual mode.
The automatic symbol is replaced by the manual symbol .
The printer writes the message “passaggio del ciclo in manuale “ (cycle switched to manual mode).
The cycle is moved on in jog mode by pressing and releasing the START button. This allows the cycle to be
completed fast, skipping the time count of the various phases.
However, operators should wait 5 ÷ 10 seconds between successive presses on the START button.
ATTENTION
Switching to manual mode always aborts the cycle even if the user press the AUT button to return
to automatic mode.
WARNING
The sterilization or test cycle is not valid.
The load in the chamber must undergo a new sterilization cycle or the test cycle must be repeated.
ATTENTION
For safety reasons, the START button cannot be pressed to reduce the time taken by the final
drying and extraction phases.
If the START button is not pressed, or the user switches to automatic mode, the single phase or the entire
cycle is performed in the same way as in the automatic cycle. In any case, the message “Ciclo abortito –
Aprire le porte” (Cycle aborted - Open the doors) appears on the display at the end of the cycle. The buzzer
also starts to sound in on-off mode and the printer records the message CYCLE ABORTED.
If the sterilization chamber door is opened, automatic operation is restored and the main menu, screen 1,
appears.
MU-S36S66-E-ED1R0 49 / 79
7.13 Stopping the sterilization cycle from the terminal
A sterilization cycle can be stopped by pressing the STOP button in the cycle execution screen
This stops the cycle and alarm screen no. 1501 (see chap. 8.2) appears. The printer prints the line “Al.
n.1501 stop ciclo da utente” (Al. no. 1051 cycle stopped by user) together with the temperature and pressure
values and date and time when the alarm occurred.
AL 1501
CYCLE STOPPED BY USER
To proceed, press the red RESET button in the bottom right-hand corner of the screen. The system will now
automatically resolve the alarm and return the sterilizer to standby condition.
ATTENTION
A cycle stop always causes the cycle to be aborted.
WARNING
The load in the chamber must undergo a new sterilization cycle or the
test cycle must be repeated.
MU-S36S66-E-ED1R0 50 / 79
7.14 Emergency manual operating mode
Follow the procedure described in MT-S36S66, Chap. 7.
7.15 Sterilizer emergency stop
A sterilizer emergency stop is obtained by pressing the stop button (Fig. 2-2, Item 2 and Fig. 2-3, Item 9) and
turning off the master switch installed by the user close to the sterilizer.
ATTENTION
An emergency stop always causes the cycle to be aborted.
WARNING
The load in the chamber must undergo a new sterilization cycle or the
test cycle must be repeated.
7.16 Modifying the sterilization cycle
Follow the procedure described in MT-S36S66, Chap. 8.
WARNING
The password giving access to the modification menus must only be
used by the responsible authority
WARNING
If the parameter values or phase sequence are modified or a new
sterilization cycle is set, the cycle must be validated before it is used
for sterilizing medical devices
MU-S36S66-E-ED1R0 51 / 79
7.17 Parameter Menu
Select the Parameters button from the main menu (page 33) to access the following screen
Configurazione (Setup) button: setting of the device data (serial number, device type, number of doors,
heating mode) and display of the software version installed (level 3 password)
Utente (User): button setting of the user name and department for the heading of the printed reports (level 2
password).
Parametri (Parameters) button: setting of the general parameters which regulate operation of the cycles
(level 3 password).
Fault Cond. button: setting of alarm trigger times (level 3 password).
These buttons can only be accessed using the passwords. Refer to the technical manual for further
information
MU-S36S66-E-ED1R0 52 / 79
7.18 Instruments menu
Select the Strumenti (Instruments) button from the main menu (page 33) to access the following screen
Controllo (Control) button: check on the transducers used to control the processes (level 3 password 3).
Registrazione (Record) button: check on the transducers used for recording (level 3 password 3).
Operatore (Operator) button. Date and time setting, setting of up to 8 operator passwords for printing of the
operator ID on the printed report (level 2 password), setting of automatic switch-on and
switch-off time.
Config. pannello (Panel setup) button: setting of date and time format, language, screen brightness and
contrast, screen saver enabling and timeout setting, and graphic interface system
settings (level 3 password).
Ingressi (Inputs) button: displays the control system input status.
Uscite (Outputs) button: displays the control system output status.
These buttons can only be accessed using the passwords. Refer to the technical manual for further
information.
7.19 Switching off the sterilizer
WARNING
The sterilizer must always be switched off by the responsible
authority.
Proceed as follows:
A) press the stop button (Fig. 2-2, Item 9);
B) turn off the master switch installed by the user;
C) turn off the stop devices installed by the user on the fluid supply pipes outside the sterilizer equipment
section;
MU-S36S66-E-ED1R0 53 / 79
7.20 Using the sterilizer
7.20.1 Starting the working session
The following is the sequence of phases to be performed to prepare the sterilizer for the start of daily
operations.
A) Switching on the sterilizer (7.2)

B) Heating (7.4)
C) Start-up
 Selection of the sterilization cycle (7.7) The Heating or Porous Load cycle is recommended
ATTENTION
The start-up cycle must be carried out with the sterilization chamber
empty.
 Closing of the door (7.5)

 Start of the sterilization cycle (7.9)
 Automatic operation (7.9)
ATTENTION
Performance of the cycle should be watched to check that the
sterilizer is operating correctly.
 Opening of the door (7.5)
7.20.2 Working session
The working session cannot start until the procedure described in point 7.20.1 has been followed.
A typical sterilization cycle must be carried out in accordance with the phase sequence listed below and the
procedures referred to:
A) Opening of the door (7.5)
B) Loading of the material for sterilizing (7.6)
C) Closing of the door (7.5)
D) Selection of the sterilization cycle (7.7)
E) Start of the sterilization cycle (7.9)
F) Automatic operation (7.9)
G) Opening of the door (7.5)
H) Unloading of the material (7.10)
I) Checking of the report (7.11)
J) Closing of the door (7.5)
ATTENTION
If sterilization cycles are not carried out in quick succession, the door
should be almost closed to reduce heat loss from the sterilizer.
7.20.3 Ending the working session
Proceed as follows:
A) close the door (7.5)
B) switch the sterilizer off (7.19)
MU-S36S66-E-ED1R0 54 / 79
7.20.4 Automatic switch-on and switch-off
Selecting the Avvio Automatico Sterilizzatrice (Sterilizer Automatic Start) button from the main menu
access the following screen:
Proceed as follows:
A) Set the Year-Month-Day when the Automatic Start is required
B) Set the Hour and Minute for switch-off
C) Set the Hour and Minute for switch-on
D) Enable Automatic Start by pressing the relative button
MU-S36S66-E-ED1R0 55 / 79
8 MALFUNCTIONS
The control system is able to identify and manage a number of fault conditions relating to sterilizer safety
factors and aspects concerning the effectiveness of the sterilization cycle.
Regardless of the type of malfunction, the following occur:

 when the fault condition is detected, the sterilizer also switches to a condition of safety
 the fault condition is indicated simultaneously by:
 the code and description of the fault condition, which appear on the display
 operation of the buzzer
 recording of the fault condition by the printer
For example, in the case of FC 901 (see Chap. 8.2), the display shows:
AL 901
CHAMBER NOT AT ATMOSPHERIC
PRESSURE
The printer records the message:
Alarm 901
chamber not at atmospheric pressure
Pr. cam:.: (Chamber pressure): -0.010 bar

temp. cam. (chamber temperature) 93.5°C
Date 19/01/06 time 10:09
Pressing the reset button in the bottom right-hand corner of the screen
stops the buzzer and starts automatic resolution of the alarm.
For automatic resolution of fault conditions, refer to Chap. 8.3.
MU-S36S66-E-ED1R0 56 / 79
8.2 List of fault conditions
This chapter describes the malfunctions which may be detected by the control system.
CODE FAULT CONDITION DESCRIPTION

AL001 Generator water level control system
AL001.1 No water minimum level signal at switch-on and in standby mode
AL001.2 No water maximum level signal at switch-on and in standby mode
AL001.3 No maximum water level signal during cycle
AL001.4 Maximum but not minimum level signal
AL001.5 No minimum water level signal during cycle
AL010 Control of fluids, electricity supply, protective devices
AL010.1 Mains water pressure reading too low
AL010.3 Overload cutout tripped
AL010.4 No compressed air pressure
AL020 Control of heating system operation
AL020.1 Generator overpressure
AL020.2 Generator safety pressure switch tripped
AL020.3 Electric heating timeout at switch-on
AL020.4 Electric heating timeout
AL020.5 Steam heating timeout at switch-on
AL020.6 Steam heating timeout
AL020.7 Jacket/generator/coil thermostat tripped
AL030 Door locking and unlocking control
AL030.1 Loading side door not locked at start of cycle
AL030.2 Unloading side door not locked at start of cycle
AL030.3 Loading side door unlocked during cycle
AL030.4 Unloading side door unlocked during cycle
AL030.5 Loading side door not unlocked at end of cycle
AL030.6 Unloading side door not unlocked at end of cycle
AL040 Door sealing and closure control
AL040.1 Door not sealed at start of cycle
AL040.2 Door sealed at end of cycle
AL040.3 Door not sealed during cycle
AL040.4 Loading side door open during cycle
AL040.5 Unloading side door open during cycle
AL050 Vacuum phase control
AL050.1 Initial vacuum not reached
AL050.2 Drying vacuum not reached
AL050.3 Vacuum Test vacuum not reached
AL050.4 Vacuum not reached during resolution of fault condition
AL050.5 Vacuum failure during Vacuum Test
AL050.6 Pulsed drying pressure balance
AL050.7 Pressure not reached during pulsed drying
AL060 Injection phase control
AL060.1 Injection pressure not reached
AL070 Sterilization phase control
AL070.1 Sterilization pressure not reached
AL070.2 Temperature below minimum value
AL070.3 Temperature above maximum value
AL070.4 Sterilization temperature not reached after 5 minutes
AL070.5 Recording temperature above maximum value.
AL070.6 Sterilization timeout (recording)
AL080 Air intake phase control
AL080.1 Pressure balancing timeout at end of cycle
MU-S36S66-E-ED1R0 57 / 79
CODE FAULT CONDITION DESCRIPTION
AL090 Sterilization chamber pressure control
AL090.1 Chamber not at atmospheric pressure
AL090.2 Master PLC CPU I/O alarm
AL090.3 Master digital I/O module alarm
AL090.5 Master PLC temperature probe alarm
AL090.6 Master PLC transducer module alarm
AL110 Control system transducer operating control
AL110.1 Chamber temperature probe error (control)
AL110.3 Chamber transducer error (control)
AL110.4 Jacket (liquid cycle) (control) probe error
AL110.5 Jacket transducer error (control)
AL110.6 Chamber mobile temperature probe error (control)
AL110.7 PLC battery flat or missing alarm
AL130 Recording system transducer operating control
AL130.1 Chamber temperature probe error (recording)
AL130.3 Chamber transducer error (recording)
AL130.4 Chamber mobile temperature probe error (recording)
AL150 Alarm resolution and communication control
AL150.1 Cycle stop from user
AL150.2 Printer error
AL150.3 Control terminal error
AL150.4 Master/slave communication alarm
AL150.5 Alarm resolution error
MU-S36S66-E-ED1R0 58 / 79
8.3 Resolution of fault conditions
This chapter describes the procedures to be followed to return the sterilizer to normal operation after a fault
condition.
8.3.1 Resolution after an alarm message
8.3.1.1 Resolution after an alarm message with sterilizer in standby mode
The alarm status can be reset by switching the sterilizer off and back on; normal operation is restored when
the sterilizer is restarted.
If the fault condition persists, the alarm status recurs.
8.3.1.2 Resolution after an alarm message with cycle in progress
After an alarm message, pressing the reset button starts the automatic end of cycle procedure described (the
buzzer is also automatically stopped).
AL 13
NO WATER MAXIMUM LEVEL SIGNAL
The following phase are performed, in this order:
 CHAMBER PRESSURE CONTROL PC
for PC > PA + DPA

 VACUUM in sterilization chamber down to the fixed value of - 0.850 bar
 AIR INTAKE to balance the pressure in the chamber
 GASKET DISCHARGE
 DOOR UNLOCK
 END OF CYCLE
for PC < PA – DPA

 AIR INTAKE to balance the pressure in the chamber
 DOOR UNLOCK
 END OF CYCLE
for PA - DPA < PC < PA + DPA

 DOOR UNLOCK
 END OF CYCLE
(PC= Chamber Pressure, PA= Atmospheric Pressure, DPA= Atmospheric Pressure Delta.)
MU-S36S66-E-ED1R0 59 / 79
 the control of all the relevant fault conditions must remain active during the procedure
 operation of the generator (heating, water filling and level control) must be disabled during the procedure
 normal operation is restored when the sterilization chamber door is opened
ATTENTION
If the fault condition is caused by a malfunction relating to
components critical for the system’s safety, the alarm status cannot
be reset by pressing the “reset” button, but only by switching the
sterilizer off and back on.
Normal operation is restored when the sterilizer is switched back on.
If the fault condition persists, the alarm status recurs (see MT-
S36S66, Chap. 9).
At the end of the automatic procedure, after opening the door of the sterilization chamber, the operator must:
A) press the stop button;
ATTENTION
Before switching the sterilizer back on, the user must identify and
remove the cause of the fault condition (see MT-S36S66, Chap. 9).
If in doubt, do not switch the sterilizer on, but:
 place the sterilizer out of use
 notify the Sordina Customer Service.
B) reset the stop button;

C) switch the sterilizer on.
WARNING
If a fault condition occurs when the sterilizer is switched on or during
execution of a cycle, the operator must:
 switch the sterilizer off
MU-S36S66-E-ED1R0 60 / 79
8.3.2 Emergency switch-off
In the extraordinary event that the sterilizer is stopped by pressing the emergency button, the following
procedure must be followed:
A) press the stop button;
ATTENTION
Before switching the sterilizer back on, the user must identify and
remove the cause of the fault condition (see MT-S36S66, Chap. 9).
If in doubt, do not switch the sterilizer on and inform the Sordina
Customer Service.
B) reset the stop button;

C) switch the sterilizer on.
WARNING
If a fault condition recurs when the sterilizer is switched on, the
operator must:
 switch the sterilizer off
MU-S36S66-E-ED1R0 61 / 79
9 CLEANING
9.1 External panels
The stainless steel panels must be cleaned with cloths dipped in hot water and non-abrasive, non-acid
detergents. Abrasive utensils must not be used. Rinse with care, using cloths dipped in hot water.
WARNING
Cleaning must always be carried out with the sterilizer off
WARNING
Never use jets or sprays of water and/or detergents
For further information, refer to MT-S36S66, Chap. 11.2.1.
9.2 Touch-screen display

The touch screen must be cleaned by wiping with a soft cloth dipped in methanol.
9.3 Door gasket and cavity
The gasket fits into a cavity in the front surface of sterilizer’s flange.
Inspect it for deposits, rubbing and/or cuts. If damage or dirt is found, clean or replace as described in MT-
S36-S66 Chap. 11.2.4.
10 MAINTENANCE
Maintenance work on the sterilizer must be performed by trained staff using genuine spare parts, in order to
maintain conformity with the requirements of Directives 93/42 EEC and 97/23/EEC.
It is the duty of the operator assigned to use the sterilizer to report any malfunctions noticed during its
operation to the responsible authority.
The routine inspections and maintenance detailed in Table 11.3.1 of MT-S36S66 must be performed by the
responsible authority or staff trained by it, in accordance with the instructions in MT-S36S66 Chap. 11.
MU-S36S66-E-ED1R0 62 / 79
11 Figures
1) sterilization chamber 8) inspection section
2) chamber door 9) inspection hatch
3) rubber gasket 10) lock with key
4) G ½ union for connection of pressure measurement 11) Panels

instruments
12) electric switchboard
5) G 1 union for the connection of temperature probes
13) control panel
6) mobile rib device
14) steam generator
7) supporting frame
15) EC 97/23 dataplate for sterilization chamber
16) EC 97/23 dataplate for steam generator
Front view with panels Front view without panels
MU-S36S66-E-ED1R0 63 / 79
View of right-hand side without panels (pass-through Front view of unloading side
model)
fig. 2-1 (a) Series S66 Sterilizers

Composition of the product
MU-S36S66-E-ED1R0 64 / 79
Front
Front view
view with
with panels
panels Frontview
Front viewwithout
withoutpanels
panels
View of right-hand side without panels Front view of unloading side
fig. 2-1 (b) (Series S36 Sterilizers)

Composition of the product
MU-S36S66-E-ED1R0 65 / 79
1) touch-screen display
2) stop button
3) printer
4) chamber vacuum gauge
5) jacket pressure gauge
6) generator pressure gauge
7) key-switch
fig. 2-2 Control panel - Loading side (non-sterile side)
MU-S36S66-E-ED1R0 66 / 79
8) touch-screen display
9) stop button
10) chamber vacuum gauge
fig. 2-3 Control panel - Unloading side (sterile side)
MU-S36S66-E-ED1R0 67 / 79
fig. 3-1 EC 93/42 dataplate O.N. 0051 - Sterilizer
fig. 3-2 EC 97/23 dataplate O.N. 0948 – Sterilization chamber
MU-S36S66-E-ED1R0 68 / 79
fig. 3-3 EC 97/23 dataplate O.N. 0948 - Steam generator
MU-S36S66-E-ED1R0 69 / 79
400 Volts
fig. 4-1 “Warning, electric shock hazard” symbol
fig. 4-2 “Warning, refer to documentation supplied” symbol (ISO 3864, No. B.3.6)
fig. 4-3 “Warning, hot surfaces” symbol
fig. 4-4 “Warning, hand injury hazard” symbol
MU-S36S66-E-ED1R0 70 / 79
fig. 4-5 “Ground connection terminal” symbol
(IEC 417, No. 5019)
fig. 4-6 “Alternating current, three-phase with neutral” symbol
fig. 4-7 “On (power supply)” symbol

(IEC 417, No. 5007)
fig. 4-8 “Off (power supply)” symbol

(IEC 417, No. 5008)
MU-S36S66-E-ED1R0 71 / 79
fig. 5-1(a) - Series S66
Marking of interior
MU-S36S66-E-ED1R0 72 / 79
fig. 5-1(b) Series S36
Marking of interior
MU-S36S66-E-ED1R0 73 / 79
EC
93/42
dataplat
e
fig. 5-2(a) Series S66

Marking of loading side front surface
MU-S36S66-E-ED1R0 74 / 79
fig. 5-3 (a) Series S66
Marking of loading side front surface (pass-through model)
MU-S36S66-E-ED1R0 75 / 79
EC
93/42
dataplat
e
fig. - 5-2 (b) Series S36

MU-S36S66-E-ED1R0 76 / 79
fig. - 5-2 A Series S3 -
fig. - 5-3 (b) Series S36

Marking of unloading side front surface
REMARKS
MU-S36S66-E-ED1R0 77 / 79
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STEAM STERILIZER

MU-S36S66-E-ED1R0 – 17/03/ 2012

1 SAFETY NOTES AND PRECAUTIONS ................................................................................................... 5

THIS DOCUMENT CONTAINS SORDINA S.p.A. PROPRIETORY INFORMATION.

REPRODUCTION AND/OR DISCLOSURE TO THIRD PARTIES WITHOUT THE WRITTEN

This document is subject to technical modifications.

Company name : SORDINA S.p.A.

MODELS STEAM PRODUCTION No.

2.4 Responsible authority

The following documentation is supplied with the sterilizer:

A) Design drawing of the pressurised vessel,

For further information, refer to MT-S36S66, Chap. 2.6.

3.1 Intended use

EN 11607-1 Packaging for terminally sterilized medical devices

Sterilizer Model Classification under Directive 97/23

The S36/S66 sterilizer conforms to the following standards:

 UNI EN 287-1:2012 Qualification testing of welders - Fusion welding - Part 1: Steels;

 EN 285:2006+A2 (May 2009 edition) Sterilization - Steam sterilizers;

 EN 17665-1:2006 Sterilization of health care products - MOIST HEAT:

Part 1: General requirements;

 EN 14971:2009 Medical devices - Application of risk management to medical devices;

 EN 62304:2006 Medical device software - Software life cycle processes;

 EN 62366:2007 Medical devices - Application of usability engineering to medical

 EN 980:2009: Graphical symbols for use in the labelling of medical devices.

The sterilizer comprises the following main parts (Fig. 2-1):

pressure vessel is constructed entirely in austenitic stainless steel.

Frame and panels

Water and steam system

It comprises (Fig. 2-2):

Control panel (pass-through model)

It comprises (Fig. 2-3):

 Stainless steel baskets

Description Code Model Application

Description Code Model

Description Code Model Application

Description Code Model Application

Description Code Model Application

3.6 Load handling accessories

They are of the following types:

 Manual, fixed height

Description Code Model Application

 Electric, adjustable height

Description Code Model Application

4.1 General information

RUBBER LOAD : intended for sterilizing rubber loads at 121°C

METAL LOAD : intended for sterilizing packaged metal loads

CONTAINER LOAD : intended for sterilizing instruments packed into containers

LIQUID CYCLE : intended for sterilizing liquids in containers (optional)

Vacuum Test : intended to check the vacuum-tightness of the sterilization chamber

Sterilization of porous loads at 134°C

Maximum load per Sterilization Unit:

Type of load Weight [kg]

Phase sequence and parameter values:

PHASE PARAMETER VALUE

Sterilization cycle duration with full load (min) 50 ÷ 80

Sterilization of packaged rubber articles at 121°C

Maximum load per Sterilization Unit:

Type of load Weight [kg]

Phase sequence and parameter values:

PHASE PARAMETER VALUE

Sterilization cycle duration with full load (min) 60 ÷ 90

Sterilization of instruments packed in reusable containers in bags, inside baskets.