Cominox SteriClave 18-24, SterilClave 18-24 Maintenance manual

4.3 (9)

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

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

INTRODUCTION................................................................................................................................

9

GENERAL SUPPLY CONDITIONS..........................................................................................................

9

PURPOSE OF THE DOCUMENT ..........................................................................................................

10

EQUIPMENT..........................................................................................................................................

10

OPERATING USE..................................................................................................................................

11

Table of cycles/sterilizable material 18B - 18BHD.....................................................................

12

Table of cycles/sterilizable material 18S ....................................................................................

13

Table of cycles/sterilizable material 24B - 24BHD.....................................................................

13

TECHNICAL SPECIFICATIONS........................................................................................................

15

Technical specifications table 18 ...............................................................................................

15

Technical specifications table 24 ..............................................................................................

16

REFERENCE STANDARDS....................................................................................................................

16

DIMENSIONS........................................................................................................................................

17

General dimensions ......................................................................................................................

17

Dimensions required when the unit is to be built-in .................................................................

17

GENERAL SAFETY CONDITIONS ....................................................................................................

18

Thermal danger .................................................................................................................................

18

Noise ....................................................................................................................................................

18

Environmental conditions and risks.................................................................................................

19

Residual risks table.........................................................................................................................

19

TRANSPORTATION AND PACKAGING..........................................................................................

20

Unpacking and cleaning the components..................................................................................

20

Storage ................................................................................................................................................

21

INSTALLATION ................................................................................................................................

22

GENERAL CONDITIONS .....................................................................................................................

22

Arrangement......................................................................................................................................

22

 

3

Table of contents

 

 

 

 

 

 

 

CONNECTIONS ...................................................................................................................................

 

 

23

Electrical connections ..................................................................................................................

23

Water connection .........................................................................................................................

23

Water supply table........................................................................................................................

24

MANUALLY FILL CLEAN WATER TANK ..............................................................................................

25

MANUALLY DRAIN TANKS..................................................................................................................

25

PREPARING FOR BUILT-IN INSTALLATION .........................................................................................

25

OPERATION ....................................................................................................................................

 

 

26

SWITCH-ON .........................................................................................................................................

 

 

26

STAND BY .............................................................................................................................................

 

 

 

28

MENU....................................................................................................................................................

 

 

 

29

1.

Cycle Menu............................................................................................................................

30

2.

Main Settings Menu...............................................................................................................

30

 

2.1

Language .......................................................................................................................

31

 

2.2

Date and Time ...............................................................................................................

31

 

2.3

Button Sound..................................................................................................................

31

 

2.4

Self-stop...........................................................................................................................

31

 

2.5

Self-filling .........................................................................................................................

32

 

2.6

Printer...............................................................................................................................

32

 

2.7

Cycle Recording ...........................................................................................................

32

 

2.8

Data Logging.................................................................................................................

32

3.

Advanced Menu Functions.................................................................................................

33

 

3.1

Prog. SPECIAL .................................................................................................................

33

 

3.2

Programmed start .........................................................................................................

34

 

3.3

Hollow Loads ..................................................................................................................

35

 

3.4a

Change sec. Code.......................................................................................................

36

 

3.4b

SterilCard Option...........................................................................................................

37

 

3.4b.1

Create User ............................................................................................................

37

 

3.4b.2

Delete User .............................................................................................................

40

 

3.4b.3

Enable User.............................................................................................................

41

4.

Cycle Records Menu ............................................................................................................

42

5.

Maintenance Menu..............................................................................................................

43

 

5.1

Items ................................................................................................................................

43

 

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

4

 

Table of contents

Printer ...................................................................................................................................................

51

Cycle Recording on SterilCard .......................................................................................................

52

INDICATORS...................................................................................................................................

54

ALARMS..........................................................................................................................................

56

List of alarm codes ............................................................................................................................

61

MAINTENANCE ..............................................................................................................................

62

GENERAL CONDITIONS ....................................................................................................................

62

Cleaning..........................................................................................................................................

62

Filters.................................................................................................................................................

63

Checks.............................................................................................................................................

63

Fuses.................................................................................................................................................

63

To calibrate the fuses 32, refer to the label plate inside the door 18.......................................

63

STORAGE AND DISPOSAL..................................................................................................................

64

Machine storage or long-term disuse.......................................................................................

64

Disposal and Scrapping ..............................................................................................................

64

Scheduled service table ..................................................................................................................

65

APPENDIX 1: GRAPHICS 18 B – 18 BHD / 24B – 24 BHD .............................................................

66

APPENDIX 2: GRAPHICS 18 S......................................................................................................

67

5

Table of contents

Reference index

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 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:chamber seal

32:fuses

6

Table of contents

Graphic representation of references Mod. 18

7

Cominox SteriClave 18-24, SterilClave 18-24 Maintenance manual

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:

 

#

18S

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

Administrator and User SterilCards 06

2

optional

optional

Printer 26

1

optional

optional

optional

Auto water fill 29

1

optional

optional

Direct drain 30

1

optional

optional

 

 

 

Supplied as standard

10

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 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 +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.

!additivedry. -free water and dried. The support for the load must also be perfectlyInstruments 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.

The sterilizer may NOT be operated or installed in areas in which gas or any other ! explosive volatile substance is present.

11

 

Introduction

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table of cycles/sterilizable material 18B - 18BHD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

121

134

 

134

121

134

134 PRION

BOWIE &

VACUUM

 

 

UN-

UN-

POROUS /

POROUS /

 

 

WRAPPED

WRAPPED

WRAPPED

HOLLOW

HOLLOW

 

DICK TEST

TEST

 

 

 

 

 

 

Type according to

N

N

S1

B

B

B

 

 

EN 13060

 

 

 

 

 

 

 

 

 

 

 

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

15'

4'

 

4'

15'

4'

18'

3.5'

-

sterilization phase

 

 

 

 

 

 

 

 

 

 

Drying

no

no

20'

20'

20'

20'

no

no

Total duration

23' - 30'

13' - 21'

 

37' - 48'

57' - 77'

49' - 69'

63' – 85'

25'

20'

(minimum - maximum)

 

 

 

 

 

 

 

 

 

 

Load:

 

 

 

 

 

 

 

 

 

 

solid

yes

yes

yes

yes

yes

yes

 

 

 

porous

no

no

no

yes

yes

yes

empty

empty

 

hollow A

no

no

no

yes

yes

yes

chamber

chamber

 

hollow b

no

no

no

yes

yes

yes

 

 

Packaging:

 

 

 

 

 

 

 

 

 

 

not packaged

yes

yes

yes

yes

yes

yes

empty

empty

 

single pack

no

no

yes

yes

yes

yes

 

chamber

chamber

 

double pack

no

no

no

yes

yes

yes

 

 

 

Maximum load weight

5 Kg

5 Kg

3 Kg

2.5 - 1.5 Kg

2.5 - 1.5 Kg

2.5 - 1.5 Kg

-

-

(solid/hollow - porous)

 

 

 

 

 

 

 

 

 

12

 

 

 

 

 

 

 

IntroductionIntroduzione

Table of cycles/sterilizable material 18S

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

121

134

134

121

134

134 PRION

BOWIE &

VACUUM

 

UN-

UN-

POROUS/

POROUS/

 

WRAPPED

WRAPPED

WRAPPED

HOLLOW

HOLLOW

 

DICK TEST

TEST

 

 

 

 

 

Type according to

N

N

S1

S2

S2

S2

 

 

EN 13060

 

 

 

 

 

 

 

 

 

 

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

15'

4'

4'

15'

4'

18'

3,5'

-

sterilization phase

 

 

 

 

 

 

 

 

Drying

no

no

25'

25'

25'

25'

no

no

Total duration

24' - 29'

14' - 19'

44' - 54'

59' - 70'

50' - 59'

64' - 74'

25'

20'

(minimum - maximum)

 

 

 

 

 

 

 

 

Load:

 

 

 

 

 

 

 

 

solid

yes

yes

yes

yes

yes

yes

 

 

porous

no

no

no

yes

yes

yes

empty

empty

hollow A

no

no

no

no

no

no

chamber

chamber

hollow b

no

no

no

yes

yes

yes

 

 

Packaging:

 

 

 

 

 

 

 

 

not packaged

yes

yes

yes

yes

yes

yes

empty

empty

single pack

no

no

yes

yes

yes

yes

chamber

chamber

double pack

no

no

no

no

no

no

 

 

Maximum load weight

5 Kg

5 Kg

3 Kg

2.5 - 1 Kg

2.5 - 1 Kg

2.5 - 1 Kg

-

-

(solid/hollow - porous)

 

 

 

 

 

 

 

 

Table of cycles/sterilizable material 24B - 24BHD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

121

134

134

121

134

134 PRION

BOWIE &

VACUUM

 

UN-

UN-

POROUS/

POROUS/

 

WRAPPED

WRAPPED

WRAPPED

HOLLOW

HOLLOW

 

DICK TEST

TEST

Type according to

N

N

S1

B

B

B

 

 

EN 13060

 

 

 

 

 

 

 

 

 

 

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

15'

4'

4'

15'

4'

18'

3,5'

-

sterilization phase

 

 

 

 

 

 

 

 

Drying

no

no

20'

20'

20'

20'

no

no

Total duration

21' - 28'

11' - 19'

37' - 49'

60' - 79'

49' - 73'

66' - 88'

25'

20'

(minimum - maximum)

 

 

 

 

 

 

 

 

Load:

 

 

 

 

 

 

 

 

solid

yes

yes

yes

yes

yes

yes

 

 

porous

no

no

no

yes

yes

yes

empty

empty

hollow A

no

no

no

yes

yes

yes

chamber

chamber

hollow b

no

no

no

yes

yes

yes

 

 

Packaging:

 

 

 

 

 

 

 

 

not packaged

yes

yes

yes

yes

yes

yes

empty

empty

single pack

no

no

yes

yes

yes

yes

chamber

chamber

double pack

no

no

no

yes

yes

yes

 

 

Maximum load weight

7.5 Kg

7.5 Kg

4 Kg

3.7 - 2.2 Kg

3.7 - 2.2 Kg

3.7 - 2.2 Kg

-

-

(solid/hollow - porous)

 

 

 

 

 

 

 

 

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 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 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).

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

dB(A) - dB(C)

 

55.7 - 62.7

 

suitable conditions (medium-peak)

 

 

 

 

 

 

Weight (mass)

kg

48,7

51

51

Weight per support area with full tank and

kg/cm²

1,16

1,2

1,2

maximum load

 

 

 

 

Room temperature allowed

°C

 

from 15 to 40

 

Maximum relative humidity allowed

%

 

85

 

Maximum altitude allowed with standard safety

m asl

1500 (2000 with replacement of the valve)

valve

 

 

 

 

Conditional connections:

 

0.139+j0.087

 

maximum impedance

 

 

 

 

 

 

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

dB(A) - dB(C)

 

56 - 63

suitable conditions (medium-peak)

 

 

 

 

 

Weight (mass)

kg

63

 

68

Weight per support area with full tank and

kg/cm²

1.53

 

1.63

maximum load

 

 

 

 

 

Room temperature allowed

°C

 

from 15 to 40

Maximum relative humidity allowed

%

 

85

Maximum altitude allowed with standard safety

m asl

1500 (2000 with replacement of the valve)

valve

 

 

 

 

Conditional connections:

 

0.153+j00.096

maximum impedance

 

 

 

 

 

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

Technical specifications

DIMENSIONS

General dimensions

 

SterilClave 18

SterilClave 24

A - Width

445

445

B - Height

390

470

C - Depth

640

700

D - Unit depth with door

880

940

open

 

 

Dimensions required when the unit is to be built-in

 

SterilClave 18

SterilClave 24

E - Width

450

450

F - Height

395

475

G - Depth

560

620

!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.NEVER place the machine on soft surfaces (such as cloth or foam) and never

Usable space dimensions

 

SterilClave 18

SterilClave 24

H - Width

185

185

I - Height

150

150

L - Depth

285

420

17

General safety conditions

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. Never stand in front of or above the door!

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).

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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 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.

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

Carefully clean the workplace.

 

circuit or pollution.

 

 

 

 

 

Drainage of waste water contaminated by

Dispose of according to the regulations in

viruses, bacteria, or pathogenic micro-

force.

 

 

 

organisms.

 

 

 

 

 

 

 

Escaping steam and/or gas fumes when

Always carefully

check

whether the

load

complies with

cycle

temperatures,

and

opening the door 16.

open the door with caution.

 

 

 

Excessively hot surfaces, especially in the

Wear protective gloves and/or never touch

sterilization chamber 09 and on certain

any internal components unless duly

solenoid valves or internal components.

AUTHORIZED.

 

 

 

The chamber seal is hermetic even when

Do not place plants or animals inside the

the unit is switched off; plants and animals

chamber.

 

 

 

cannot survive inside the machine.

 

 

 

 

Poor cleaning or scratching of label plates

Clean instruments and label plates carefully

and/or instrumentation can lead to mistakes

with the appropriate products.

 

and consequent dangers.

 

 

 

 

Poor training of personnel.

Request an additional training course from

COMINOX.

 

 

 

 

 

 

 

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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.

!The packed sterilizer must be lifted after being fitted onto the special pallet, and only using forklifts.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 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 parts.

Unpacking and cleaning the components

!adhesive tape, straps, ropes, etc.) can cut and/or injure if not carefully handled.Remember that packaging (wood, nails, paper, cellophane, metal staples,

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).

!

In the event of defects or wear and tear, immediately interrupt any

operation,

contact the shipping or forwarding agent, and promptly inform COMINOX.

 

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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 concentrated on protruding feet or screws.

Ideal ambient storage conditions are:

-temperature with empty systems - 25°C + 40°C.

-maximum relative humidity 90%.

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