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
Table of contents
TABLE OF CONTENTS
TABLE OF CONTENTS........................................................................................................................ 3
Reference index .............................................................................................................................. 6
Graphic representation of references Mod. 18 ......................................................................... 7
Graphic representation of references Mod. 24 ......................................................................... 8
STAND BY ............................................................................................................................................. 28
5.2 Save Maintenance ....................................................................................................... 44
INFORMATION in STAND BY .............................................................................................................. 45
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
01: tray handle
02: waste pipe
03: power cable
04: tray
05: metering funnel
06: SterilCard
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 st raps
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: chamber seal
32: fuses
6
Graphic representation of references Mod. 18
Table of contents
7
Table of contents
Graphic representation of references Mod. 24
8
Introduction
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.
9
Introduction
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:
Support for 5 trays or 3 cassettes 081
Metering funnel 05 with cap 1
Administrator and User SterilCards 062 optional optional
Printer 261 optional optional optional
Auto wate r fill 29 1 optional optional
Direct drain 30 1 optional optional
• • •
• • •
• • •
• • •
• • •
• • •
• • •
• • •
•
Supplied as standard
•
•
•
10
!
r
)
y
r
Introduction
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.
Check that that the product to be sterilized can withstand a temperature highe
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 +3°C (standard EN 13060: minimum temperature =
sterilization temperature -0°C; maximum temperature = sterilization temperature
+4 °C
.
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.
Instruments and fabrics to be sterilized MUST be carefully washed, rinsed with
!
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.
additive-free water and dried. The support for the load must also be perfectl
dry.
The sterilizer may NOT be operated or installed in areas in which gas or any othe
explosive volatile substance is present.
!
11
Introduction
Table of cycles/sterilizable material 18B - 18BHD
Type according to
EN 13060
Temperature
Pressure
Duration of
sterilization phase
Drying
Total duration
(minimum - maximum)
Load:
solid
porous
hollow A
hollow b
Packaging:
not packaged
single pack
double pack
Maximum load weight
(solid/hollow - porous)
121
UN-
WRAPPED
134
UN-
WRAPPED
134
WRAPPED
121
POROUS /
HOLLOW
134
POROUS /
HOLLOW
134 PRION
BOWIE &
DICK TEST
VACUUM
TEST
N N S1 B B B
121°C 134°C 134°C 121°C 134°C 134°C 134°C -
2.1 bar 3.1 bar 3.1 bar 2.1 bar 3.1 bar 3.1 bar 3.1 bar -
no no no yes yes yes
no no no yes yes yes
no no no yes yes yes
yes yes yes yes yes yes
no no yes yes yes yes
no no no yes yes yes
7.5 Kg 7.5 Kg 4 Kg 3.7 - 2.2 Kg 3.7 - 2.2 Kg 3.7 - 2.2 Kg - -
empty
chamber
empty
chamber
empty
chamber
empty
chamber
13
Introduction
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
and where the length of the cavity is no longer than 3000 mm (L
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
where the diameter of the cavity is greater than or equal to 5 mm (D
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 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).
≤ 3000 mm).
≥ 5 mm).
≤ L/D ≤ 1500),
≤ L/D ≤ 10), and
≤
14
Technical specifications
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)
Weight (mass) kg 48,7 51 51
Weight per support area with full tank and
maximum load
Room temperature allowed °C from 15 to 40
Maximum relative humidity allowed % 85
Maximum altitude allowed with standard safety
valve
Conditional connections:
maximum impedance
dB(A) - dB(C) 55.7 - 62.7
kg/cm² 1,16 1,2 1,2
m asl 1500 (2000 with replacement of the valve)
Ω 0.139+j0.087
15
Technical specifications
Technical specifications table 24
U.M. B BHD
Steam generation 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 420-1040 420-1190
Minimum water load cm³ 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)
Weight (mass)
Weight per support area with full tank and
maximum load
Room temperature allowed
Maximum relative humidity allowed
Maximum altitude allowed with standard safety
valve
Conditional connections:
maximum impedance
dB(A) - dB(C) 56 - 63
kg 63 68
kg/cm² 1.53 1.63
°C from 15 to 40
% 85
m asl 1500 (2000 with replacement of the valve)
Ω 0.153+j00.096
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
16
r
Technical specifications
DIMENSIONS
General dimensions
SterilClave 18SterilClave 24
A - Width 445 445
B - Height 390 470
C - Depth 640 700
D - Unit depth with door
open
Dimensions required when the unit is to be built-in
SterilClave 18SterilClave 24
E - Width 450 450
F - Height 395 475
G - Depth 560 620
880 940
NEVER place the machine on soft surfaces (such as cloth or foam) and neve
!
Usable space dimensions
SterilClave 18SterilClave 24
H - Width 185 185
I - Height 150 150
L - Depth 285 420
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.
17
General safety conditions
r
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
!
The temperature in the sterilization chamber is controlled by a safety thermostat17 that
intervenes if overheating occurs. The safety thermostat must be reset manually.
stand in front of or above the door!
Noise
The sound pressure level (noise) detected in suitable work spaces must be lower than
70dB(A).
18
General safety conditions
Environmental conditions and risks
The sterilizer may not be installed in the open or be exposed to unfavourable weather
conditions (sun, rain, snow, wind).
In addition, make sure that there is no electromagnetic interference that could
!
!
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
Losses or leaks with risks of slipping, short
circuit or pollution.
Drainage of waste water contaminated by
viruses, bacteria, or pathogenic microorganisms.
Escaping steam and/or gas fumes when
opening the door 16.
Excessively hot surfaces, especially in the
sterilization chamber 09 and on certain
solenoid valves or internal components.
The chamber seal is hermetic even when
the unit is switched off; plants and animals
cannot survive inside the machine.
Poor cleaning or scratching of label plates
and/or instrumentation can lead to mistakes
and consequent dangers.
Poor training of personnel.
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.
RISK ANALYSIS AND DESCRIPTION SUGGESTED REMEDY
Carefully clean the workplace.
Dispose of according to the regulations in
force.
Always carefully check whether the load
complies with cycle temperatures, and
open the door with caution.
Wear protective gloves and/or never touch
any internal components unless duly
AUTHORIZED.
Do not place plants or animals inside the
chamber.
Clean instruments and label plates carefully
with the appropriate products.
Request an additional training course from
COMINOX.
19
Transportation and packaging
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.
Lifting means should not damage or compromise the operation of the sterilizer.
!
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.
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
and the waste water recovery tank 11.
!
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.
Never lift or move the sterilizer using the door 16 or holding onto other plastic
!
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).
parts.
Remember that packaging (wood, nails, paper, cellophane, metal staples,
adhesive tape, straps, ropes, etc.) can cut and/or injure if not carefully handled.
20
In the event of defects or wear and tear, immediately interrupt any operation,
contact the shipping or forwarding agent, and promptly inform COMINOX.
Transportation and packaging
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.
Never place any objects on top of the machine packaging, especially with loads
!
Ideal ambient storage conditions are:
- temperature with empty systems - 25°C + 40°C.
- maximum relative humidity 90%.
concentrated on protruding feet or screws.
21
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