COMINOX Sterilclave 6 B Speedy 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. 6 ........................................................................... 7
INTRODUCTION ................................................................................................................................ 9
GENERAL SUPPLY CONDITIONS.......................................................................................................... 9
PURPOSE OF THE DOCUMENT .......................................................................................................... 10
EQUIPMENT.......................................................................................................................................... 10
OPERATING USE .................................................................................................................................. 11
Table of cycles/sterilizable material 6 B SPEEDY....................................................................... 12
TECHNICAL SPECIFICATIONS........................................................................................................14
Technical specifications table 6 B SPEEDY ................................................................................ 14
REFERENCE STANDARDS.................................................................................................................... 14
DIMENSIONS........................................................................................................................................ 15
General dimensions ...................................................................................................................... 15
Dimensions required when the unit is to be built-in ................................................................. 15
Usable space dimensions............................................................................................................. 15
GENERAL SAFETY CONDITIONS .................................................................................................... 16
Thermal danger ................................................................................................................................. 16
Noise .................................................................................................................................................... 17
Environmental conditions and risks................................................................................................. 17
Residual risks table......................................................................................................................... 17
TRANSPORTATION AND PACKAGING.......................................................................................... 18
Unpacking and cleaning the components .................................................................................. 18
Storage ................................................................................................................................................ 19
INSTALLATION ................................................................................................................................ 20
GENERAL CONDITIONS ..................................................................................................................... 20
Arrangement...................................................................................................................................... 20
CONNECTIONS ................................................................................................................................... 21
Electrical connections .................................................................................................................. 21
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Water connection ......................................................................................................................... 21
Water supply table ........................................................................................................................ 21
MANUALLY FILL/EMPTY CLEAN WATER TANK ................................................................................. 22
PREPARING FOR BUILT-IN INSTALLATION ......................................................................................... 22
OPERATION .................................................................................................................................... 23
SWITCH-ON ......................................................................................................................................... 23
STAND BY ............................................................................................................................................. 27
MENU.................................................................................................................................................... 28
1. Cycle Menu ............................................................................................................................ 29
2. Main Settings Menu............................................................................................................... 29
2.1 Language ....................................................................................................................... 30
2.2 Date and Time ............................................................................................................... 30
2.3 Button Sound.................................................................................................................. 30
2.4 Self-stop........................................................................................................................... 30
2.5 Self-filling ......................................................................................................................... 31
2.6 Printer............................................................................................................................... 31
2.7 Cycle Recording ........................................................................................................... 31
2.8 Data Logging................................................................................................................. 31
3. Advanced Menu Functions................................................................................................. 32
3.1 Prog. SPECIAL ................................................................................................................. 32
3.2 Programmed start ......................................................................................................... 33
3.3 Hollow Loads .................................................................................................................. 34
3.4a Change sec. Code....................................................................................................... 35
3.4b SterilCard Option........................................................................................................... 36
3.4b.1 Create User ............................................................................................................ 36
3.4b.2 Delete User ............................................................................................................. 39
3.4b.3 Enable User............................................................................................................. 40
4. Cycle Records Menu ............................................................................................................ 41
5. Maintenance Menu.............................................................................................................. 42
5.1 Items ................................................................................................................................ 42
5.2 Save Maintenance ....................................................................................................... 43
INFORMATION in STAND BY .............................................................................................................. 44
STARTING the CYCLE ......................................................................................................................... 45
STOP the CYCLE ............................................................................................................................. 46
EVENTS in the CYCLE ..................................................................................................................... 47
INFORMATION about the CYCLE ................................................................................................ 48
PLOT of the CYCLE......................................................................................................................... 48
CONTROL TESTS .................................................................................................................................. 49
Bowie & Dick test ........................................................................................................................... 49
Vacuum test ................................................................................................................................... 49
Helix test .......................................................................................................................................... 51
Printer ................................................................................................................................................... 51
Cycle Recording on SterilCard ....................................................................................................... 52
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INDICATORS................................................................................................................................... 54
ALARMS.......................................................................................................................................... 56
List of alarm codes ............................................................................................................................ 62
MAINTENANCE .............................................................................................................................. 63
GENERAL CONDITIONS ..................................................................................................................... 63
Cleaning.......................................................................................................................................... 63
Filters................................................................................................................................................. 64
Checks............................................................................................................................................. 64
Fuses................................................................................................................................................. 64
STORAGE AND DISPOSAL.................................................................................................................. 65
Machine storage or long-term disuse ........................................................................................ 65
Disposal and Scrapping ............................................................................................................... 65
Scheduled service table .................................................................................................................. 66
APPENDIX 1: GRAPHICS 6 B SPEEDY ............................................................................................ 67
Table of contents

6
Reference index
01: tray handle
02: waste pipe
03: power cable
04: tray
05: metering funnel
06: SterilCard
08: support for 2 trays
09: chamber
10: clean water tank
12: chamber safety valve
12A: steam generator safety valve
13: main switch
14: filler
15: air sterilization filter
16: door
17: chamber safety thermostat
17A: steam generator safety thermostat
18: inferior panel
20: waste filter
22: adjustable feet
23: lifting straps
24: clean water tap
26: printer
29: auto water fill
30: direct drain
31: door gasket
32: fuses
47: steam generator
Table of contents

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Graphic representation of references Mod. 6
Table of contents

8
Table of contents

9
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.
IntroductionIntroduction

10
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
# 6 B SPEEDY
Tray handle 01 1 •
Waste pipe 02 1 •
Power cable 03 1 •
Trays 04 2
Support for trays 08 1 •
Metering funnel 05 with cap 1 •
Administrator and User SterilCards 06 2 •
Printer 26 1 optional
Auto water fill 29 1 optional
Direct drain 30 1 •
Introduction

11
For every sterilization cycle, introduce a chemical process indicator in the load o
r
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 o
f
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 tools (e.g. scalpels), hollow tools 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 (see Preparation of the load to be
sterilized). 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 EN868.
!
Check that that the product to be sterilized can withstand a temperature highe
r
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 standard 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 perfectl
y
dry.
!
The sterilizer may NOT be operated or installed in areas in which gas or any othe
r
explosive volatile substance is present.
!
Introduction

12
Table of cycles/sterilizable material 6 B SPEEDY
121
UN-
WRAPPED
134
UN-
WRAPPED
134
DENTAL
HAND
PIECES
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 (°C) 121 134 134 121 134 134 134 -
Pressure (bar) 2,1 3,1 3,1 2,1 3,1 3,1 3,1 -
Duration of
sterilization phase 15' 4' 4' 15' 4' 18' 3.5' -
Drying no no no 14' 14' 14' 4’ no
Total duration
(minimum) 18' 8' 8' 33' 24' 35' 17' 17'
Load:
solid yes yes yes yes yes yes
porous no no no yes yes yes
hollow A no no yes yes yes yes
hollow B no no yes yes yes yes
empty
chamber
empty
chamber
Packaging:
not packaged yes yes yes yes yes yes
single pack no no no yes yes yes
double pack no no no yes yes yes
empty
chamber
empty
chamber
Maximum load weight
(solid/hollow - porous) 3,5 Kg 3,5 Kg 0,6 Kg 1,7 – 0,6 Kg 1,7 – 0,6 Kg 1,7 – 0,6 Kg - -
NOTE
CYCLE N: sterilization cycle for solid instruments, unpackaged only.
CYCLE S1: sterilization cycle for solid instruments, 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.
Introduction

13
TOTAL MAXIMUM DURATION: the total time the sterilizer requires to run a complete cycle,
calculated from cold startup (room temperature) and maximum load.
TOTAL MINIMUM DURATION: the total time the sterilizer requires to run a complete cycle,
including hot startup (one cycle after the other) and minimum load (load support only).
Introduction

14
TECHNICAL SPECIFICATIONS
Technical specifications table 6 B SPEEDY
U.M. 6 B SPEEDY
Steam generation Independent generator
Chamber capacity l 4,8
Clean water tank capacity l 2,1
Water consumption per cycle
(minimum/maximum) cm³ 200 - 500
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 (single-phase AC)
Maximum allowed voltage fluctuations % ±10
Absorbed maximum power W 1800
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 40
Weight per support area with full tank and
maximum load kg/cm² 0,96
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)
REFERENCE STANDARDS
SterilClave sterilizers were conceived and designed in conformity with the following
directives and standards:
Directives
97/23/CE Pressure equipment
93/42/EEC Medical devices (class II a)
89/336/CEE Electromagnetic compatibility (and subsequent updates)
73/23/CEE Low voltage (and subsequent updates)
Standards
EN 13060 Small steam sterilizers
EN 61010-1 Safety regulations for laboratory devices - Part 1: General regulations
EN 61010-2-040 Safety regulations specific to sterilizers used in the processing of medical
material.
EN 61326-1 Electromagnetic compatibility regulations for laboratory devices
Technical specifications

15
DIMENSIONS
General dimensions
SterilClave 6
Width 385
Height 370
Depth 535
Unit depth with door open 690
Dimensions required when the unit is to be built-in
SterilClave 6
Width 390
Height 375
Depth 505
Usable space dimensions
SterilClave 6
Width 185
Height 100
Depth 285
NEVER place the machine on soft surfaces (such as cloth or foam) and neve
r
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, as illustrated.
!
Technical specifications

16
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 machine 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.
When opening the door 16, steam may escape, which could cause burns. Neve
r
stand in front of or above the door!
!
Do not push the button of door 16 during a cycle!
!
General safety conditions

17
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).
Environmental conditions and risks
The sterilizer may not be installed in the open or be exposed to unfavourable weather
conditions (sun, rain, snow, wind).
COMINOX is not liable for the disposal of materials required for the operation or
production of the sterilizer (e.g.: plastic packaging or potentially contaminated waste
water...). The client must personally provide for the removal of any substances that are
potentially harmful to the environment in compliance with regulations in force in the
country of installation.
The same precautions apply to scrapping the sterilizer.
The sterilizer was designed in compliance with best practices concerning energy
conservation, preventing needless waste.
Residual risks table
RISK ANALYSIS AND DESCRIPTION SUGGESTED REMEDY
Losses or leaks with risks of slipping, short
circuit or pollution. Carefully clean the workplace.
Drainage of waste water contaminated by
viruses, bacteria, or pathogenic micro-
organisms.
Dispose of according to the regulations in
force.
Escaping steam and/or gas fumes when
opening the door 16.
Always carefully check whether the load
complies with cycle temperatures, and
open the door with caution.
Excessively hot surfaces, especially in the
sterilization chamber 09 and on certain
solenoid valves or internal components.
Wear protective gloves and/or never touch
any internal components unless duly
AUTHORIZED.
The chamber seal is hermetic even when
the unit is switched off; plants and animals
cannot survive inside the machine.
Do not place plants or animals inside the
chamber.
Poor cleaning or scratching of label plates
and/or instrumentation can lead to mistakes
and consequent dangers.
Clean instruments and label plates carefully
with the appropriate products.
Poor training of personnel. Request an additional training course from
COMINOX.
In addition, make sure that there is no electromagnetic interference that could
affect the data in the electronic devices.
!
The unit is not equipped as standard for operation in environments that present a
particular risk of fire or explosion.
!
General safety conditions

18
TRANSPORTATION AND PACKAGING
During transport, the sterilizer is protected by a cardboard box.
Lifting and transportation are to be carried out by qualified personnel only.
Weights and dimensions of occupied space are provided in the DIMENSIONS chapter and
in the Technical specifications table.
Transportation of the sterilizer, particularly by road, must be conducted using means of
transportation that can adequately protect the components (especially electronic
components) against violent knocks, humidity, vibrations, and so on.
COMINOX does not accept sterilizers for repair if they have full tanks (see Chap.
MANUALLY DRAIN TANKS).
Very heavy items or equipment (heavier than 30 kg) must only be moved or lifted using
appropriate lifting devices.
At least two people are required for manual lifting, using the special lifting straps 23
provided and following the correct procedures as specified by current regulations.
Unpacking and cleaning the components
They should be removed using appropriate means and not left within reach of
unauthorized persons (especially children). The same applies to any device used to
remove packaging (scissors, hammers, tongs, knives, etc.).
Packaging components must be removed and disposed of according to the regulations
in force in each country.
You are advised to retain the packaging and the lifting straps 23 for possible moves in the
future.
When opening the package, the first thing to do is check all the pieces and parts of the
sterilizer. Check that all components required are present and in perfect condition (see
SUPPLY CONDITIONS).
Remove the supplied parts by opening the door 16 (see OPERATION).
Transportation and packaging
Lifting means should not damage or compromise the operation of the sterilizer.
The packed sterilizer must be lifted after being fitted onto the special pallet, and
only using forklifts.
!
The sterilizer may be transported only after fully emptying the clean water tank
10.
!
Remember that packaging (wood, nails, paper, cellophane, metal staples,
adhesive tape, straps, ropes, etc.) can cut and/or injure if not carefully handled.
!
In the event of defects or wear and tear, immediately interrupt any operation,
contact the shipping or forwarding agent, and promptly inform COMINOX.
!
Never lift or move the sterilizer using the door 16 or holding onto other plastic
parts.
!

19
The load support system and the external surface of the sterilizer are sometimes protected
by a plastic film: it must be removed before using the machine.
Storage
If the sterilizer will not be used immediately or if will be removed from the installation site, it
must be stored in a dry, protected location.
If you wish to cover the machine with plastic sheeting, you must first insert silica gel or other
desiccant systems inside the packaging.
Ideal ambient storage conditions are:
- temperature with empty systems - 25°C + 40°C.
- maximum relative humidity 90%.
Never place any objects on top of the machine packaging, especially with loads
concentrated on protruding feet or screws.
!
Transportation and packaging

20
INSTALLATION
GENERAL CONDITIONS
Installation of the sterilizer is to be carried out according to Customer requirements and
those of the site where the machine is to be installed. Therefore, it is important that the
Customer promptly informs COMINOX of any special situations (such as ambient
conditions, size, or built-in limits).
In general, it is necessary to:
- check that any ambient conditions are acceptable (explosion risk, excessive ventilation,
or high humidity).
- check that the unit is not exposed to any adverse weather conditions, such as sun, rain,
wind, etc.
- check that the power supply complies with the specifications provided on the label
plates affixed to the machine.
- check that the power supply is properly grounded.
Arrangement
The sterilizer should be installed in a laboratory or medical or dental office where it can be
accessed exclusively by authorized personnel.
IT IS NOT BE INSTALLED:
- near sources of heat.
- in rooms where volatile explosive substances are kept.
- under or above any live equipment.
- in unsuitable built-in units.
- without the fitted adjustable feet.
- in domestic environments accessible to untrained personnel.
- on surfaces that are flammable, soft, unstable, or have wheels.
Position the unit in the area where it will be installed, on a sturdy, perfectly horizontal
surface.
When installing the unit for the first time (and whenever it is removed from its original
installation location), follow the procedure indicated below:
- position the sterilizer where it will be installed and do not move it thereafter.
- loosen the clamping nuts and adjust the adjustable feet 22 so that the distance between
the table by the feet and the sterilizer bottom is 2,5 cm.
- after leveling, tighten the clamping nuts on the adjustable feet 22.
Installation
The operation must be performed by trained, qualified personnel only: it is
important to comply with the specifications in this manual and follow the
technical diagrams and documents.
!
Avoid any electro-magnetic interference that could affect the proper operation
of electronic equipment, leading to consequent dangers.
!
WARNING: NEVER REMOVE THE FEET COMPLETELY
Do not block the space under the sterilizer.
!