CertoClav Vacuum Pro 45 User manual

CERTOCLAV Sterilizer GmbH, Peintner Straße 10, A
-
4060 Leonding / Austria
Instruction Manual
CertoClav Vacuum Pro 45
Steam Steriliser Model STE-45-T

Dear customer,
Thank you for the trust you have placed in us by purchasing this autoclave.
CertoClav, a medium-sized family company, has specialised in the manufacture of table-
top autoclaves for more than 60 years.
This autoclave has been manufactured and tested according to strict requirements.
However, please read through this instruction manual carefully.
The long-lasting functionality and value retention of your autoclave depend primarily on
the maintenance of the device.
Instruction Manual CertoClav Vacuum Pro 45
CertoClav
Valid for model STE-45-T
Issue 1 June 2019
Responsible for content:
CERTOCLAV Sterilizer GmbH
Peintner Straße 10
A-4060 Leonding
Austria
Email: [email protected]
www.certoclav.com
© 2019 CertoClav
Last change: 11.06.2019
Document: BA_VACPRO45_D.doc / Revision: 8
Subject to technical changes
Symbolic images: Images may differ from the original
Table of Contents

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
3
1 General Information 6
1.1 Intended use 6
1.2 Environmental protection 6
1.3 Customer Service 6
1.4 Ordering spare parts and special accessories 7
1.5 Guarantee 7
2 Meaning of the Symbols on the Autoclave 8
3 Safety Information 9
4 Non-autoclavable Substances 10
5 Initial Start-up 11
5.1 Device description 11
5.2 Device dimensions 11
5.3 Scope of supply 12
5.4 Before initial start-up 12
6 Installation 13
6.1 Setting up the autoclave 13
6.2 Unlocking the autoclave door 14
6.3 Touchscreen assembly 14
6.4 Installing accessories 16
6.4.1 Connecting the protocol printer 16
6.4.2 Connecting the barcode reader 16
6.4.3 Connecting the label printer 16
6.4.4 Connecting the CertoServer 17
6.5 Pressure sensor calibration 17
6.6 Validation and calibration 18
7 Sterilisation Programs 19
7.1 Default settings 19
7.2 Editing program parameters 20
8 Basic Operation 21
8.1 Switching on the touchscreen 21
8.2 Switching off the touchscreen 21
8.3 Standby Mode for the touchscreen 21
9 Instructions for Daily Use 22
9.1 Preparations before use 22
9.2 Replenishing with distilled water 22
9.3 Opening the autoclave door 23

4
9.4 Steps to start a sterilisation process 24
9.4.1 Selecting the sterilisation program on the screen 24
9.4.2 CertoTrace –Documentation and load management 25
9.4.3 Step-by-step video assistant 26
9.4.4 Loading the autoclave 26
9.4.5 Closing the autoclave door 26
9.4.6 Material tests and automatic repetitions 27
9.4.7 Status screen 27
9.5 Unloading the autoclave 28
9.6 Emptying the used water tank 29
9.7 PC software 29
9.7.1 Functions of the CertoCloud 30
9.7.2 Display of sterilisation protocols via web browser 31
10 Control Panel of the Autoclave 32
10.1 Login Menu 32
10.2 Support Menu 34
10.2.1 Tutorial videos 34
10.2.2 Send email to CertoSupport 35
10.2.3 TeamViewer, remote support and share screen 36
10.3 Protocols Menu 38
10.3.1 Viewing protocols 38
10.3.2 Printing protocols 38
10.3.3 Example of a protocol printout 39
10.3.4 Print barcode 39
10.3.5 Tracing marked products 40
11 Settings 41
11.1 User administration 41
11.2 Network settings 41
11.2.1 Connecting to a WLAN network 41
11.2.2 Connecting to a LAN network 42
11.2.3 Network communication 42
11.2.4 Connecting to the CertoServer 43
11.2.5 Connecting to the CertoCloud server 44
11.3 Sterilisation settings 45
11.3.1 Customising sterilisation programs 45
11.3.2 Material tests and automatic repetitions 45

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
5
11.3.3 CertoTrace — Your support during material tests 47
11.3.4 Label designer 47
11.3.5 Real-time protocolling to USB 48
11.3.6 Exporting all protocols to a USB 48
11.3.7 Exporting all protocols to an SD card 49
11.3.8 Exporting all protocols via a network 50
11.4 System settings 51
11.4.1 Changing the date and time 51
11.4.2 Installing updates via the Internet 51
11.4.3 Installing updates via USB 52
11.4.4 Installing updates via SD card 53
11.4.5 Restoring the default settings 53
11.4.6 Changing the language 54
11.5 Configuration of SMS and email notifications 54
11.6 Sensor calibration 55
11.7 GLP and GMP data 55
11.7.1 Header 55
11.7.2 Autoclave designation 55
11.7.3 Project designation 55
11.7.4 Advanced GLP and GMP settings 56
11.8 Locking settings 56
12 Error Messages 57
13 Maintenance 59
14 Transport and Storage 60
14.1 Preparations 60
14.2 Emptying the water containers 60
14.3 Transport conditions 60
14.4 Storage conditions 60
15 Technical Data 61
16 Appendix 62
16.1 Appendix 1: Structural diagram 62
16.2 Appendix 2: Circuit diagram 63
16.3 Appendix 3: CE Declaration of Conformity for Autoclave 63
16.4 Appendix 4: CE Declaration of Conformity for Safety Valve 65

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
6
1 General Information
Dear customer,
Before putting your autoclave into operation for the first time,
please read through this instruction manual and follow its
information and instructions. Do not use another instruction
manual.
This instruction manual applies only to the CertoClav Vacuum
Pro Series autoclaves with model designation STE-45-T.
Keep this instruction manual within easy reach for later use or
for subsequent owners.
1.1 Intended use
This autoclave is intended for laboratory use. For example for the sterilisation ofliquids,
solids, waste and textiles as well as swabs, glasses, petri dishes, porous materials,
powder, hollow bodies and instruments. Containers sealed with compressed air must
not be sterilised. This autoclave has not been developed for private use.
Operation and maintenance of the autoclave may only be performed by trained
personnel.
Comply consistently with all safety regulations in this instruction manual.
1.2 Environmental protection
The packaging materials are recyclable. Please do not dispose of the
packaging in domestic waste but instead hand it over for recycling.
Old devices contain valuable recyclable materials, which should
undergo recycling. Please therefore dispose of old devices via
suitable collection systems.
1.3 Customer Service
If you have any questions or problems regarding the autoclave, please contact your
dealer or the manufacturer by email to [e-mail].

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
7
1.4 Ordering spare parts and special accessories
Use original accessories only and original spare parts for maintenance,
which are approved by the manufacturer, so as not to impair the safety
of the device.
You can obtain spare parts and accessories from your dealer or from the
manufacturer.
1.5 Guarantee
The guarantee is valid for 2 years. The claim to free service shall be nullified if one of
the following conditions is not met:
• The damage has been caused by incorrect installation.
• The damage has been caused by negligent conduct.
• The damage has been caused by improper operation.
• The damage has been caused by force majeure such as fire.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
8
2 Meaning of the Symbols on the Autoclave
ATTENTION!
PROTECTIVE EARTH CONNECTION
HOT SURFACE, KEEP AWAY
MANUFACTURER
COMMUNAUTÉ EUROPÉENNE
SERIAL NUMBER
ENVIRONMENTAL PROTECTION

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
9
3 Safety Information
Besides the information in this instruction manual, the general safety and accident
prevention regulations of the legislation must be observed.
Please read carefully! To avoid personal injury, fire or damage to the
autoclave, please pay attention to the following safety rules:
Do not install the autoclave anywhere where the power supply cannot be
disconnected quickly.
Operate the autoclave with the supply voltage indicated on the type plate of the
autoclave only.
DANGER Use a socket with protective conductor and make sure that the
protective conductor is well earthed.
Do not touch the mains plug or socket with wet hands.
Do not strain, bend or twist the cables. Do not place any heavy objects on the
cables.
Do not block the door of the autoclave.
Do not cover the ventilation openings on the rear of the autoclave.
If you notice any unusual odours or noises during operation, disconnect the
autoclave immediately from the power supply and contact your dealer or the
manufacturer by email to [e-mail].
WARNING If you do not operate the autoclave for a longer period, please
disconnect it from the power supply and empty the internal water tank.
Do not modify the device.
The autoclave must not be installed anywhere where there is a risk of explosion.
Do not autoclave containers sealed with compressed air, as these containers
could implode or explode.
Fill the water tank with distilled or demineralised water only.
Please fill the bottles and other containers with liquid to maximum half only.
Only remove containers with liquids from the chamber as soon as a liquid
temperature of less than 80 °C is measured. There is a risk of boiling
retardation of the liquid.
If the pressure is relieved rapidly during autoclaving of liquids owing to a
program termination, there is a risk boiling retardation of the liquid. Therefore
please always wait until the temperature of the medium has reached ≥80 °C
before opening the autoclave.
The autoclave must not be transported full.
The autoclave must not be opened with force.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
10
4 Non-autoclavable Substances
Never use the autoclave to sterilise the following materials or alkaline solutions. The
sterilisation of such substances can cause an explosion, corrosion of the sterilisation
chamber, pipes or wear to the seals.
Explosive substances
−Nitroglycol, nitroglycerin, nitrocellulose and other explosive nitric acid esters
−Trinitrobenzene, trinitrotoluene, picric acid and other explosive nitro compounds
−Peracetic acid, methyl ethyl ketone peroxide, benzoyl peroxide and other
organic peroxides
Combustible substances
−Metallic lithium, potassium, sodium, yellow phosphorous, phosphorous
sulphide, red phosphorous
−Celluloids, calcium carbide (carbide), calcium phosphide, magnesium powder
−Aluminium powder, magnesium powder, metal powders apart from aluminium
powder
−Sodium dithionite (or sodium hydrosulphite)
Oxidising agents
−Potassium chlorate, sodium chlorate, ammonium chlorate and other chlorates
−Potassium perchlorate, sodium perchlorate, ammonium perchlorate and other
perchlorates
−Potassium peroxide, sodium peroxide, barium peroxide and other inorganic
peroxides
−Potassium nitrate, sodium nitrate, ammonium nitrate and other nitrates
−Sodium chlorite and other chlorites
−Calcium hypochlorite and other hypochlorites
Flammable substances
−Ethyl ether, benzine, acetaldehyde, propylene oxide, carbon disulphide and
other substances whose flashpoint is in the range from -30 to 0 °C
−Methanol, ethanol, xylene, benzyl acetate (or amyl acetate) and other
substances whose flashpoint is between 0 and 30 °C
−Kerosene, gas oil, turpentine oil, isopentyl alcohol (or isoamyl alcohol), acetic
acid and other substances whose flashpoint is between 30 and 65 °C
−Flammable gas (hydrogen, acetylene, ethylene, methane, ethane, propane,
butane and other substances, which work at a temperature of 60 °C at an
absolute pressure of 0.2 bar)

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
11
If a salty solution is spilled inside the chamber, remove all liquid from
the chamber and wipe up the liquid around the door seal. Clean the
door seal with distilled or demineralised water.
5 Initial Start-up
Check whether all parts are provided when unpacking. If any parts or missing or you
discern transport damage during unpacking, please contact your dealer or the
manufacturer immediately by email to [e-mail].
5.1 Device description
This autoclave is an automatic steam steriliser with vacuum pump and steam
generator. Depending on the program and setting, the sterilisation temperature is
between 105 °C and 134 °C. Solid materials and liquids can be sterilised. The
autoclave has a flexible media sensor in order to measure and control the temperature
directly in the medium. The program parameters and sterilisation programs are
displayed on the front LCD screen as well as the mobile touchscreen. If a problem is
discerned during the sterilisation process, the autoclave automatically issues an error
message. If the boiler pressure or boiler temperature are too high, the autoclave will
automatically disconnect the power supply and thus guarantee the safety of the
operator. The autoclave is equipped with an internal water tank for fresh and used
water.
5.2 Device dimensions
F G H
Touchscreen 200
mm
128
mm
178
mm
106
5
84
0
64
0
56
0
76
0

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
12
5.3 Scope of supply
Standard scope of supply
•CertoClav Vacuum Pro 45
•Declaration of Conformity
•Instruction Manual
•1 power cable for the autoclave
•1 waste water hose
•1 mobile touchscreen
•1 power cable for the touchscreen
•1 base for the touchscreen with four fastening screws
•1 interface box for the touchscreen
•1 data cable (2 m length)
•1 tray set with 3 screws
Recommended accessories
Product Order number
CertoServer for automatic backups with browser-based interface 8500508
CertoCloud Premium licence for the online autoclave management platform
www.certocloud.com
8500212
Baseplate for bottles 8500404A
Wire basket including drip pan 8500406
Distillation device for water 8500482
Log printer 1300187
Thermal paper 8500496
Label printer 8500502
Barcode reader 8500503
Direct thermal labels 8500507
5.4 Before initial start-up
Unpacking
the autoclave
This autoclave is delivered in a wooden crate. The metal tabs on the
bottom of the crate can be opened with a large slotted screwdriver.
After this the wooden crate can be raised and removed.
Location
Install the autoclave in a dry location free of dust. The air humidity
should be between 30 –60 % and the ambient temperature 5 –26 ˚C.
Make sure that the table is suitable for the weight of the autoclave.
Scope of
supply
The touchscreen and remaining accessories are in the autoclave
chamber when delivered.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
13
6 Installation
6.1 Setting up the autoclave
If you wish to place the autoclave on a laboratory table, check whether the table is
suitable for the weight of the autoclave.
For problem-free operation, the autoclave must be aligned by adjusting the device feet
using spirit level in direction inclined backwards so that condensation can drain off in
the drainage port at the rear end of the autoclave. The autoclave should be installed
horizontally in a vertical direction.
Please leave at least 10 cm free space around the
autoclave. Leave at least 20 cm free space at the ventilation
slits on the right of the autoclave. Make sure that the room
is well ventilated
Keep the specified distance to the surrounding areas.
Failure to comply can lead to heat accumulation. This could
impair the function of the autoclave and shorten the service
life of the pressure pump and result in prolonged program
times.
Connect the power cable to the device socket on the rear of the autoclave.
Note: Check whether the data on the type plate of the autoclave correspond to the
data for the power source. Check whether the safety switch of the autoclave is in the
upper position. Switch on the autoclave at the rocker switch.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
14
6.2 Unlocking the autoclave door
The touchscreen and remaining accessories are in the autoclave chamber when
delivered.
To open the autoclave door, please hold the UP arrow for about 3 seconds until you
hear the electronic interlock humming. The door now opens the you ca remove the
content and continue installation.
6.3 Touchscreen assembly
Mount the base with the four screws supplied on the
touchscreen.
After assembling the base, the touchscreen should
appear as shown in the figure opposite.
Connecting the touchscreen to the interface box.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
15
Connecting the power cable of the touchscreen to
the interface box.
Place the touchscreen on an even stable surface
only. You can also place the watertight touchscreen
on the autoclave or next to it.
Connect the autoclave to the RS232 cable at the COM4-port of the extension box to
the RS232-port on the rear of the autoclave.
Switch on the touchscreen.
If a login window appears on the screen after several seconds, the touchscreen is
correctly connected to the autoclave.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
16
If a notification indicating a connection failure with the autoclave appears on the screen,
the touchscreen and autoclave are not connected correctly. Check whether the
autoclave is switched on and connected to the COM4-port of the interface box.
6.4 Installing accessories
Optionally available accessories.
6.4.1 Connecting the protocol printer
Connect the protocol printer (thermal or dot-matrix printer)
to the COM1-port of the interface box. You can find the
connecting cable in the box for the protocol printer. Follow
the instructions in the protocol printer manual.
6.4.2 Connecting the barcode reader
Connect the barcode reader to the USB port of the interface
box. You can find the connecting cable in the box for the
barcode reader. Follow the instructions in the barcode
reader manual.
6.4.3 Connecting the label printer
Connect the label printer to the COM2-port of the interface
box. You can find the connecting cable in the box for the
label printer. Follow the instructions in the label printer
manual.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
17
6.4.4 Connecting the CertoServer
If you do not have an Internet connection but wish to use
the CertoCloud, we recommend connecting the local
CertoServer to the autoclave.
6.5 Pressure sensor calibration
As the atmospheric pressure depends on the installation site, you should recalibrate
the pressure sensor after changing the installation site.
Calibration method:
The autoclave is calibrated via the Service screen on the front of the autoclave. The
Calibration Menu should only be operated by trained personnel. To access the
Calibration Menu, hold down the UP and DOWN arrow keys simultaneously for 10
seconds while switching on the autoclave. To calibrate the pressure sensor to
atmospheric pressure, open the door of the autoclave and confirm P-ZERO with the M
button.
If the pressure sensor has not been calibrated properly after
installing the autoclave, a situation may occur where the autoclave
fails to start a program.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
18
6.6 Validation and calibration
All sensors of the autoclave have been validated and calibrated at the factory. The
autoclave has a G ¼ access on the side panel of the chamber for calibration purposes.
We recommend using battery powered sensors such as those made by EBRO. If a
calibration on site is necessary after installation, ask your dealer or contact the
manufacturer directly by email. To obtain instructions for calibrating the autoclave,
please ask your dealer for IQ/OQ documentation or send an email to
[e-mail].
The temperature sensors should be calibrated by trained technical
personnel only.
To access the calibration menu, hold down the UP and DOWN arrow keys
simultaneously for 10 seconds while switching on the autoclave. This menu lets you
display and edit the current offset values of the chamber temperature probe, heating
temperature probe, steam generator temperature probe or media temperature probe.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
19
7 Sterilisation Programs
7.1 Default settings
Program
Vacuu
m
phases
Sterilisation
time [min]
Sterilisation
temperature
[°C]
Sterilisation
pressure
[kPa]
Vacuum
retention time
[min]
Drying time
[min]
134°C SOLID
1 4 134 210 - 5
VACUUM TEST
1 - - -75 10 15
121°C WRAPPED
3 20 121 110 - 5
134°C WRAPPED
3 4 134 210 - 5
B&D TEST
3 3.5 134 210 - -
HELIX TEST
3 3.5 134 210 - -
134°C PRION
3 -134 -75 15 -
121°C LIQUID
- 30 121 110 - -
The SOLID program should only be used for unwrapped solids. Hollow bodies of type
A and B or porous materials cannot be sterilised with this program.
The VACUUM TEST program performs a pressure leak test.
The WRAPPED programs are suitable for the sterilisation of porous material, hollow
bodies of type A and B, packaged waste and instruments. Both programs do not differ
in end result. If the load is temperature sensitive and cannot therefore be sterilised at
134°C, please select the 121°C program.
The B&D TEST or HELIX TEST program tests hollow bodies of type A. The programs
are almost identical. The only difference involves the fact that the B&D TEST program
is a B&D test package, while the HELIX TEST is used as a test device. (PCD: Process
Challenge Device).
The 134°C PRION program is specially designed for the sterilisation of prions on all
kinds of surface.

Instruction Manual CertoClav Vacuum Pro 45 l — Model STE-45-T
20
The 121°C LIQUID program is used for the sterilisation of liquids in bottles and other
open vessels. We recommend using the integrated flexible media sensor for this
program. The media sensor is immersed in the liquid medium or in a reference glass
with distilled water during the sterilisation. The autoclave now adjusts the retention time
during sterilisation so that the medium retains the required sterilisation temperature for
at least 30 minutes. If you do not use the media sensor the media temperature cannot
be recorded during sterilisation.
Never place pressure-sealed bottles, bags or containers without
pressure equalisation mechanism into the autoclave. These could
explode due to overpressure during cooling.
Only fill the glasses to maximum half their capacity.
Please perform a vacuum test each month. If the program is not
completed successfully, please contact your dealer or the
manufacturer by email ([e-mail]).
All programs can be customised by the user.
7.2 Editing program parameters
To edit the program parameters, press and hold the M key for 5 seconds while
switching on the autoclave at the rocker switch.
Use the arrow keys to toggle between the menu entries.
Use the M key to confirm and save an entry.
Use the Enter key to cancel the process. A menu for editing the program parameters
opens. Select the desired program to change the retention time and drying time after
the sterilisation phase.
Retention time: 1-59 minutes.
Drying time: 1-19 minutes. Setting parameter N to 0 deactivates the drying.