COMINOX SterilClave 18 VLS User manual

USE and MAINTENANCE MANUAL
-Steam sterilizer-
FOREWORD
This manual must be considered an integral part of the sterilizer, and must always be
available to users. The manual must always accompany the sterilizer, even if it is sold to
another user.
All operators are responsible for reading this manual and for strictly complying with the
instructions and information it provides. COMINOX is not liable for any damage to people,
things, or the sterilizer itself in the event that the operator fails to comply with the
conditions described in the manual.
These instructions are confidential and the customer may not disclose any information to
third parties. Further, this documentation and its attachments may not be tampered with
or modified, copied, or ceded to third parties without authorization from COMINOX.

2

3
TABLE OF CONTENTS
TABLE OF CONTENTS........................................................................................................................ 3
Reference index .............................................................................................................................. 6
Graphic representation of references Mod. 18 ......................................................................... 7
Graphic representation of references Mod. 24 ......................................................................... 8
INTRODUCTION.............................................................................................................................. 11
GENERAL SUPPLY CONDITIONS........................................................................................................ 11
PURPOSE OF THE DOCUMENT .......................................................................................................... 12
EQUIPMENT.......................................................................................................................................... 12
OPERATING USE .................................................................................................................................. 13
Table of cycles/sterilizable material 18B - 18BHD..................................................................... 14
Table of cycles/sterilizable material 18S .................................................................................... 14
Table of cycles/sterilizable material 24B - 24BHD..................................................................... 15
Table of cycles/sterilizable material 24S .................................................................................... 15
TECHNICAL SPECIFICATIONS........................................................................................................ 17
Technical specifications table 18 ............................................................................................... 17
Technical specifications table 24 ............................................................................................... 18
REFERENCE STANDARDS.................................................................................................................... 18
DIMENSIONS........................................................................................................................................ 19
General dimensions ...................................................................................................................... 19
Dimensions required when the unit is to be built-in ................................................................. 19
GENERAL SAFETY CONDITIONS .................................................................................................... 20
Thermal danger ................................................................................................................................. 20
Noise .................................................................................................................................................... 20
Environmental conditions and risks................................................................................................. 21
Residual risks table......................................................................................................................... 21
TRANSPORTATION AND PACKAGING.......................................................................................... 22
Unpacking and cleaning the components .................................................................................. 22
Storage ................................................................................................................................................ 23
INSTALLATION ................................................................................................................................ 24
GENERAL CONDITIONS ..................................................................................................................... 24
Table of contents

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Arrangement...................................................................................................................................... 24
CONNECTIONS ................................................................................................................................... 25
Electrical connections .................................................................................................................. 25
Water connection ......................................................................................................................... 25
Water supply table ........................................................................................................................ 26
MANUALLY FILL CLEAN WATER TANK .............................................................................................. 27
MANUALLY DRAIN TANKS.................................................................................................................. 27
PREPARING FOR BUILT-IN INSTALLATION ......................................................................................... 27
OPERATION.................................................................................................................................... 28
SWITCH-ON ......................................................................................................................................... 28
STAND BY ............................................................................................................................................. 29
MENU.................................................................................................................................................... 30
1.Cycle Menu............................................................................................................................ 31
2.Main Settings Menu............................................................................................................... 31
2.1Language ....................................................................................................................... 32
2.2Date and Time ............................................................................................................... 32
2.3Button Sound.................................................................................................................. 32
2.4Self-stop........................................................................................................................... 32
2.5Self-filling ......................................................................................................................... 33
2.6Printer............................................................................................................................... 33
2.7Cycle Recording ........................................................................................................... 33
2.8Data Logging................................................................................................................. 33
3.Advanced Tools Menu ......................................................................................................... 34
3.1Prog. SPECIAL ................................................................................................................. 34
3.2Programmed start ......................................................................................................... 35
3.3Hollow Loads .................................................................................................................. 36
3.4Code option................................................................................................................... 37
3.4.1Create User ................................................................................................................ 38
3.4.2Delete User ................................................................................................................. 40
4.Cycle Records Menu ............................................................................................................ 41
4.1BACK UP...................................................................................................................... 41
4.2Cycle records ............................................................................................................ 42
5.Maintenance Menu.............................................................................................................. 44
5.1Items ................................................................................................................................ 44
5.2Save Maintenance ....................................................................................................... 45
INFORMATION in STAND BY .............................................................................................................. 46
STARTING the CYCLE ......................................................................................................................... 47
STOP the CYCLE ............................................................................................................................. 48
EVENTS in the CYCLE ..................................................................................................................... 50
INFORMATION about the CYCLE ................................................................................................ 51
PLOT of the CYCLE......................................................................................................................... 51
CONTROL TESTS .................................................................................................................................. 52
Bowie & Dick test ........................................................................................................................... 52
Vacuum test ................................................................................................................................... 52
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Helix test .......................................................................................................................................... 54
Printer ................................................................................................................................................... 54
Cycle Recording on SD CARD ........................................................................................................ 55
INDICATORS................................................................................................................................... 56
ALARMS.......................................................................................................................................... 57
List of alarm codes ............................................................................................................................ 62
MAINTENANCE .............................................................................................................................. 64
GENERAL CONDITIONS ..................................................................................................................... 64
Cleaning.......................................................................................................................................... 64
Filters................................................................................................................................................. 65
Checks............................................................................................................................................. 65
Fuses................................................................................................................................................. 65
STORAGE AND DISPOSAL.................................................................................................................. 66
Sterilizer storage or long-term disuse .......................................................................................... 66
Disposal and scrapping................................................................................................................ 66
Maintenance schedule table ......................................................................................................... 67
APPENDIX 1: GRAPHICS 18 B – 18 BHD / 24B – 24 BHD .............................................................. 68
APPENDIX 2: GRAPHICS 18 S / 24 S .............................................................................................69
Table of contents

6
Reference index
01: tray handle
02: waste pipe
03: power cable
04: tray
05: metering funnel
06: USB port
06A: frontal serial port
07: pouch holders
08: support for 5 trays or 3 cassettes
09: chamber
10: clean water tank
11: waste water recovery tank
12: safety valve
13: main switch
14: filler
15: air sterilization filter
16: door
17: safety thermostat
18: print door
19: coil covering grid
20: waste filter
21: chamber probe
22: adjustable feet
23: lifting straps
24: clean water tap
25: waste water tap
26: printer
27: level testing pipe
28: grid seal
29: auto water fill
30: direct drain
31: door gasket
32: fuses
Table of contents

7
Graphic representation of references Mod. 18
Table of contents

8
Graphic representation of references Mod. 24
Table of contents

9
06
06A
OPTIONAL
OPTIONAL
Table of contents

10

11
INTRODUCTION
GENERAL SUPPLY CONDITIONS
COMINOX declares that the sterilizer complies with the standards and regulations in force
in the European Economic Community and issues the attached DECLARATION OF
CONFORMITY.
COMINOX will repair any manufacturing defects that arise within 24 months from the time
the sterilizer is installed (refer to the Guarantee). The chamber 09 is guaranteed for 10
years.
The customer must use original spare parts only and fit them according to their intended
use.
Responsibility for commercial components lies with their manufacturers.
COMINOX is not liable for defects or malfunctions deriving from improper use of the
sterilizer, changes that occur during transportation, or those caused by specific
environmental conditions, lack of maintenance or maintenance conducted improperly,
or problems due to tampering or incorrect repairs.
COMINOX declines all responsibility if the sterilizer is not installed properly or if it is not
installed by duly trained and qualified personnel.
COMINOX IS NOT responsible for the disposal of the products required for the transport or
operation of the sterilizer or for production materials: packaging, waste water, lubricants,
etc. The customer is individually responsible, under the specific regulations and standards
in force in each installation country, for disposing of any substances that are potentially
harmful to the environment.
The same precautions apply to scrapping the sterilizer.
Introduction

12
PURPOSE OF THE DOCUMENT
This Use and Maintenance Manual aims to provide the operator with a useful guide for:
•understanding the correct procedures for installing the sterilizer;
•explaining the various SterilClave functions;
•ensuring optimal use of the sterilizer;
•operating in complete safety;
•conducting the maintenance required for proper upkeep of the sterilizer.
EQUIPMENT
In addition to this Use and Maintenance Manual, each sterilizer is supplied with a
Guarantee Certificate and the EC Declaration of Conformity.
The Cominox SterilClave sterilizer also includes the following accessories:
•Supplied as standard
# 18S – 24S 18B – 24B 18BHD – 24BHD
Tray handle 01 1 •••
Waste pipe 02 1 •••
Level testing pipe27 1 •••
Grid seal 28 1 •••
Power cable 03 1 •••
Trays 04 3 •••
Pouch holders 07 1 optional optional optional
Support for 5 trays or 3 cassettes 08 1 •••
Metering funnel 05 with cap 1 •••
USB port 06 1 optional optional optional
Printer 26 1 optional optional optional
Auto water fill 29 1 optional optional •
Direct drain 30 1 optional optional •
Introduction

13
For every sterilization cycle, introduce a chemical process indicator in the load or
in each packaging. It verifies the sterilization process through the colour change
when the sterilization values for time, temperature and steam saturation are
reached.
In the end of the cycle, check the chemical indicator to monitor the reaching of
the correct sterilization conditions in the chamber 09.
!
OPERATING USE
Under no circumstances should the sterilizer or its parts be used for any purpose other than
those described below.
The sterilizer was designed to: STERILIZE
AUTOCLAVABLE SURGICAL, DIAGNOSTIC OR MEDICAL INSTRUMENTS
for example: SCISSORS, SCALPEL, GAUZE, FABRICS
Various types of materials can be sterilized, such as: stainless steel, glass, rubber, plastic,
cotton, fabrics in general.
The EN 13060 standard distinguishes various types of load depending on the material to be
sterilized: solid loads (e.g. scalpels), hollow loads of type A or type B (e.g. surgical
extraction cannula) and porous loads (e.g. fabrics and gauzes). This division should guide
the operator in selecting the sterilization cycle (see Table of cycles/sterilizable material).
Strictly comply with the sterilization instructions and information specified by the
manufacturer for any material to be sterilized.
Comply with the maximum total load weight (see Table of cycles/sterilizable material).
Use the load support system supplied by COMINOX. Use of load supports other than the
standard support provided may compromise the steam penetration and drying
performance confirmed during approval tests.
Follow instructions concerning correct packaging, and only use packaging materials
compliant with standard EN 868.
! Check that the product to be sterilized can withstand a temperature higher
than the temperature of the programmed cycle.
Observe the normal usage conditions described. COMINOX guarantees that the
maximum measurable temperature in chamber 09 will be: PROGRAMMED
STERILIZATION TEMPERATURE -0°C/+4°C (as stated in EN 13060).
Instruments and fabrics to be sterilized MUST be carefully washed, rinsed with
additive-free water and dried. The support for the load must also be perfectly
dry.
!
The sterilizer may NOT be operated or installed in areas in which gas or any other
explosive volatile substance is present.
!
Introduction

14
Table of cycles/sterilizable material 18B - 18BHD
121
UN-
WRAPPED
134
UN-
WRAPPED
134
WRAPPED
121
POROUS /
HOLLOW
134
POROUS /
HOLLOW 134 PRION BOWIE &
DICK TEST
VACUUM
TEST
Type according to
EN 13060 N N S1 B B B
Temperature 121°C 134°C 134°C 121°C 134°C 134°C 134°C -
Pressure 2.1 bar 3.1 bar 3.1 bar 2.1 bar 3.1 bar 3.1 bar 3.1 bar -
Duration of
sterilization phase 15' 4' 4' 15' 4' 18' 3.5' -
Drying no no 20' 20' 20' 20' 5’ no
Total duration
(minimum - maximum) 23' - 30' 13' - 21' 37' - 48' 57' - 77' 49' - 69' 63' – 85' 35' 20'
Load:
solid yes yes yes yes yes yes
empty
chamber
empty
chamber
porous no no no yes yes yes
hollow A no no no yes yes yes
hollow B no no no yes yes yes
Packaging:
not packaged yes yes yes yes yes yes
empty
chamber
empty
chamber
single pack no no yes yes yes yes
double pack no no no yes yes yes
Maximum load weight
(solid/hollow - porous) 5 Kg 5 Kg 3 Kg 2.5 - 1.5 Kg 2.5 - 1.5 Kg 2.5 - 1.5 Kg - -
Table of cycles/sterilizable material 18S
121
UN-
WRAPPED
134
UN-
WRAPPED
134
WRAPPED
121
POROUS/
HOLLOW
134
POROUS/
HOLLOW 134 PRION BOWIE &
DICK TEST
VACUUM
TEST
Type according to
EN 13060 N N S1 S2 S2 S2
Temperature 121°C 134°C 134°C 121°C 134°C 134°C 134°C -
Pressure 2.1 bar 3.1 bar 3.1 bar 2.1 bar 3.1 bar 3.1 bar 3.1 bar -
Duration of
sterilization phase 15' 4' 4' 15' 4' 18' 3,5' -
Drying no no 25' 25' 25' 25' 5’ no
Total duration
(minimum - maximum) 24' - 29' 14' - 19' 44' - 54' 59' - 70' 50' - 59' 64' - 74' 35' 20'
Load:
solid yes yes yes yes yes yes
empty
chamber
empty
chamber
porous no no no yes yes yes
hollow A no no no no no no
hollow B no no no yes yes yes
Packaging:
not packaged yes yes yes yes yes yes
empty
chamber
empty
chamber
single pack no no yes yes yes yes
double pack no no no no no no
Maximum load weight
(solid/hollow - porous) 5 Kg 5 Kg 3 Kg 2.5 - 1 Kg 2.5 - 1 Kg 2.5 - 1 Kg - -
Introduction

15
Table of cycles/sterilizable material 24B - 24BHD
121
UN-
WRAPPED
134
UN-
WRAPPED
134
WRAPPED
121
POROUS/
HOLLOW
134
POROUS/
HOLLOW
134
PRIONS BOWIE & DICK TEST
VACUUM
TEST
Type according to
EN 13060 N N S1 B B B
Temperature 121°C 134°C 134°C 121°C 134°C 134°C 134°C -
Pressure 2.1 bar 3.1 bar 3.1 bar 2.1 bar 3.1 bar 3.1 bar 3.1 bar -
Duration of
sterilization phase 15' 4' 4' 15' 4' 18' 3,5' -
Drying no no 20' 20' 20' 20' 5’ no
Total duration
(minimum - maximum) 21' - 28' 11' - 19' 37' - 49' 60' - 79' 49' - 73' 66' - 78' 35' 20'
Load:
solid yes yes yes yes yes yes
empty
chamber
empty
chamber
porous no no no yes yes yes
hollow A no no no yes yes yes
hollow B no no no yes yes yes
Packaging:
not packaged yes yes yes yes yes yes
empty
chamber
empty
chamber
single pack no no yes yes yes yes
double pack no no no yes yes yes
Maximum load weight
(solid/hollow - porous) 7.5 Kg 7.5 Kg 4 Kg 3.7 - 2.2 Kg 3.7 - 2.2 Kg 3.7 - 2.2 Kg - -
Table of cycles/sterilizable material 24S
121
UN-
WRAPPED
134
UN-
WRAPPED
134
WRAPPED
121
POROUS/
HOLLOW
134
POROUS/
HOLLOW
134
PRIONS BOWIE & DICK TEST
VACUUM
TEST
Type according to
EN 13060 N N S1 S2 S2 S2
Temperature 121°C 134°C 134°C 121°C 134°C 134°C 134°C -
Pressure 2,1 bar 3,1 bar 3,1 bar 2,1 bar 3,1 bar 3,1 bar 3,1 bar -
Duration of
sterilization phase 15' 4' 4' 15' 4' 18' 3,5' -
Drying no no 25' 25' 25' 25' 5’ no
Total duration
(minimum - maximum) 25' - 30' 16' - 20' 46' - 52' 61' - 71' 51' - 62' 68' - 78' 35' 19'
Load:
solid yes yes yes yes yes yes
empty
chamber
empty
chamber
porous no no no yes yes yes
hollow A no no no no no no
hollow B no no no yes yes yes
Packaging:
not packaged yes yes yes yes yes yes
empty
chamber
empty
chamber
single pack no no yes yes yes yes
double pack no no no no no no
Maximum load weight
(solid/hollow - porous) 7,5 Kg 7,5 Kg 4 Kg 3,7 – 1,5 Kg 3,7 – 1,5 Kg 3,7 – 1,5 Kg - -
IntroductionIntroduction

16
NOTE
CYCLE N: sterilization cycle for solid instruments, unpackaged only.
CYCLE S1: sterilization cycle for solid instruments, packaged or unpackaged.
CYCLE S2: sterilization cycle for solid instruments, porous loads, and hollow loads type B,
packaged or unpackaged.
CYCLE B: sterilization cycle for solid instruments, porous loads, and hollow loads type A or B,
packaged or unpackaged; double packaging is also permitted.
TYPE A HOLLOW LOADS: instruments with an open cavity on one side only, where the
length to cavity diameter ratio is greater than or equal to 1 and less than or equal to 750
(1 ≤L/D ≤750), and where the length of the cavity is no longer than 1500 mm (L ≤1500
mm). Alternatively, instruments with an open cavity on both sides, whose length to cavity
diameter ratio is greater than or equal to 2 and less than or equal to 1500 (2 ≤L/D ≤1500),
and where the length of the cavity is no longer than 3000 mm (L ≤3000 mm).
TYPE B HOLLOW LOADS: instruments with an open cavity on one side only, where the
length to cavity diameter ratio is greater than or equal to 1 and less than or equal to 5 (1 ≤
L/D ≤5), and where the diameter of the cavity is greater than or equal to 5 mm (D ≥5
mm). Alternatively, instruments with an open cavity on both sides, whose length to cavity
diameter ratio is greater than or equal to 2 and less than or equal to 10 (2 ≤L/D ≤10), and
where the diameter of the cavity is greater than or equal to 5 mm (D ≥5 mm).
MAXIMUM LOAD WEIGHT: the maximum weight permitted for each load category
described, including the load support system and its packaging.
TOTAL MAXIMUM DURATION: the total time the sterilizer requires to run a complete cycle,
calculated from cold start-up (room temperature) and maximum load.
TOTAL MINIMUM DURATION: the total time the sterilizer requires to run a complete cycle,
including hot start-up (one cycle after the other) and minimum load (load support only).
Introduction

17
TECHNICAL SPECIFICATIONS
Technical specifications table 18
U.M. S B BHD
Steam generation in chamber in chamber in chamber
Chamber capacity l 17,15
Clean water tank capacity l 2,1
Waste water recovery tank capacity l 2,1
Water consumption per cycle
(minimum/maximum) cm³ 180 - 500 210 - 700 210 - 700
Minimum water load cm³ 500 700 700
Maximum flow discharge rate (direct) cm³/s 30
Maximum discharge temperature (direct) °C 83
Absolute operating pressure (maximum) kPa 331
Electrical voltage and frequency V - Hz 230 – 50/60 (single-phase AC)
Maximum allowed voltage fluctuations % ±10
Absorbed maximum power W 2000
Heat emission J/h 0,3
Detected noise level in work areas under
suitable conditions (medium-peak) dB(A) - dB(C) 55,7 – 62,7
Weight (mass) kg 48,7 51 51
Weight per support area with full tank and
maximum load kg/cm² 1,16 1,2 1,2
Room temperature allowed °C from 15 to 40
Maximum relative humidity allowed % 85
Maximum altitude allowed with standard safety
valve m asl 1500 (2000 with replacement of the valve)
Conditional connections:
maximum impedance Ω0.139+j0.087
Technical specifications

18
Technical specifications table 24
U.M. S B BHD
Steam generation in chamber in chamber in chamber
Chamber capacity l 23,15
Clean water tank capacity l 3,1
Waste water recovery tank capacity l 3.1
Water consumption per cycle
(minimum/maximum) cm³ 420-990 420-1040 420-1190
Minimum water load cm³ 990 1040 1190
Maximum flow discharge rate (direct) cm³/s 30
Maximum discharge temperature (direct) °C 83
Absolute operating pressure (maximum) kPa 331
Electrical voltage and frequency V - Hz 230 – 50/60 (single-phase AC)
Maximum allowed voltage fluctuations % ±10
Absorbed maximum power W 2800
Heat emission J/h 0.3
Detected noise level in work areas under
suitable conditions (medium-peak) dB(A) - dB(C) 56 - 63
Weight (mass) kg 62 63 68
Weight per support area with full tank and
maximum load kg/cm² 1.51 1.53 1.63
Room temperature allowed °C from 15 to 40
Maximum relative humidity allowed % 85
Maximum altitude allowed with standard
safety valve m asl 1500 (2000 with replacement of the valve)
Conditional connections:
maximum impedance Ω0.153+j00.096
REFERENCE STANDARDS
SterilClave sterilizers were conceived and designed in conformity with the following
directives and standards:
Directives
97/23/EC Pressure equipment
93/42/EEC Medical devices (class IIb) (and subsequent updates)
89/336/EEC Electromagnetic compatibility (and subsequent updates)
2006/95/EC Low voltage
Standards
EN 13060:2005 Small steam sterilizers
EN 61010-1:2001 Safety regulations for laboratory devices - Part 1: General regulations
EN 61010-2-040:2005 Safety regulations specific to sterilizers used in the processing of
medical material.
EN 61326-1:2007 Electromagnetic compatibility regulations for laboratory devices
Technical specifications

19
DIMENSIONS
General dimensions
SterilClave 18 SterilClave 24
Width 445 445
Height 390 470
Depth 640 700
Unit depth with door open 880 940
Dimensions required when the unit is to be built-in
SterilClave 18 SterilClave 24
Width 450 450
Height 395 475
Depth 560 620
Usable space dimensions
SterilClave 18 SterilClave 24
Width 185 185
Height 150 150
Depth 285 420
NEVER place the sterilizer on soft surfaces (such as cloth or foam) and never
remove the adjustable feet.
Leave approximately 20 mm of space for rear ventilation. Built-in units require an
additional 20 mm between the unit and the wall. In this case, the unit must have
a rear opening for ventilation.
!
Technical specifications

20
GENERAL SAFETY CONDITIONS
•Switch off the sterilizer at the main switch 13 and disconnect the power cable 03
before conducting any operations apart from those in the normal operations cycle.
•The main power supply must be properly grounded.
•It is essential that operators are properly educated. It is therefore compulsory for
them to read and comply with the technical information provided in the manual
and attached documentation. The use of unqualified personnel is strictly
prohibited.
•Personnel who operate the sterilizer must always use the appropriate individual
protective devices: gloves for sharp or pointed objects and heated elements, and
the special tray handle for emptying the chamber.
•Avoid any temporary repairs: repairs must be performed exclusively with original
spare parts, and these must be installed by an authorized technician.
•Never remove or dismantle any part from the sterilizer. Only authorized personnel
trained in advance by COMINOX may remove the exterior protective cover and
access the interior parts.
•Labeling plates on the unit should not be removed, damaged, or dirtied. They must
be kept clean and clearly visible.
•Do not use the sterilizer if there are possible defects in its operation.
•The sterilizer should be cleaned using suitable means and detergents that will not
damage or corrode any sterilizer components. It is strictly forbidden to clean or
wash the sterilizer with jets of water.
•Never place containers of liquids on the sterilizer or the shelves above it. Leakage or
spillage on the electric system can cause a short circuit.
•Do not place flammable or toxic materials and products for sterilization in the
chamber 09.
•Do not use the sterilizer to process containers that hold fluids, whether they are
sealed or not.
•Never lean on the door 16.
The information in this manual does not replace any safety instructions or technical data
for installation and operation on the unit itself, nor any safety standards in force in the
installation country, or the rules of common sense.
Thermal danger
Interior parts of the door 16 and of the chamber 09 can reach extremely high
temperatures.
Never touch the heated surfaces until they have cooled, and always use the appropriate
protective gloves. The same applies when a load is to be removed from the sterilization
chamber. To remove the trays 04 holding the load, always use the tray handle 01. Never
leave the tray handle inside the sterilization chamber.
The temperature in the sterilization chamber is controlled by a safety thermostat 17 that
intervenes if overheating occurs. The safety thermostat must be reset manually.
Noise
The sound pressure level (noise) detected in suitable work spaces must be lower than
70dB(A).
General safety conditions
When opening the door 16, steam may escape, which could cause burns.
Never stand in front of or above the door!
!