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Operation Qualification Page 1/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

TABLE OF CONTENTS
1.0 PRODUCT NAME......................................................................................................................3
2.0 USE OF THE DEVICE .................................................................................................................4
2 .1 SWITCHING THE DEVICE ON ...................................................................................................4
2.2 CONTROL PANEL …………….......................................................................................................4
3.0 USER INTERFACE …………….......................................................................................................5
3.1 HOME SCREEN (HOME) ..........................................................................................................5
3.1.1 HOME SCREEN IN STOPPED CONDITION ................................................................................5
3.1.2 HOME SCREEN WHILE THE PROGRAM IS RUNNING ...............................................................5
3.1.3 PROGRAM SCHEME AND TIME DATA FOR CURRENT SEGMENT ............................................6
3.2 MENU PROGRAM ……………………..............................................................................................6
3.2.1 PROGRAM SELECTION ............................................................................................................7
3.2.2 PROGRAM ………………..............................................................................................................7
3.2.3 PROGRAM PARAMETERS ........................................................................................................8
4.0 MAIN MENU………………………………...........................................................................................9
4.1 DELAYED START ......................................................................................................................9
4.2 PROGRAMS EDITING .............................................................................................................11
4.3 ALARMS ………………………………………….....................................................................................11
4.4 PROTECTIVE THERMOSTAT …………………………….....................................................................12
4.5 EXPORT ……………………………………………………………………….......................................................13
4.6 IMPORT ……….........................................................................................................................14
4.7 SYSTEM INFORMATION ........................................................................................................14
5.0 MENU SETTING …..................................................................................................................15
5.1 DATE AND TIME ………….........................................................................................................15
5.2 SETTING THE FAN IN THE DEVICE CHAMBER ........................................................................16
5.3 HEPA FAN SETTING ...............................................................................................................17
5.4 DOOR LOCK ………...................................................................................................................17
5.5 COMMUNICATION ................................................................................................................18
5.6 ENTERNET …………………..........................................................................................................19
5.7 SERIAL PORT .........................................................................................................................19
5.8 USB ……………….......................................................................................................................20
5.9 PRINT ……………………………......................................................................................................20
6.0 PROTECTION …………..............................................................................................................22
6.1 PASSWORD EDITING .............................................................................................................23
6.2 KEYS COMBINATIONS ………………………...................................................................................23
6.3 USER SETTING …………….........................................................................................................24
6.4 LANGUAGE ………...................................................................................................................24
6.5 SOUNDS ………………….............................................................................................................24
6.6 UNITS ………............................................................................................................................25
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Operation Qualification Page 2/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

7.0 THE PROGRAM IS RUNNING .................................................................................................25


7.1 TRANSITION TO ECONOMIC MODE ......................................................................................26
7.2 DOOR OPENING ....................................................................................................................26
7.3 USEFUL SPACE ………..............................................................................................................27
7.4 CHARGE LAY-OUT IN THE CHAMBER ....................................................................................28
8.0 TEST PROTOCOL ………...........................................................................................................30
8.1 TEST PROTOCOL ....................................................................................................................30
9.0 MEASURING POSITION .........................................................................................................31
10.0 PERSONNEL IDENTIFICATION ................................................................................................32

1.0 PRODUCT NAME


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Operation Qualification Page 3/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

The electrically heated heating cabinets are designed for laboratories in general to uniformly
temper various types of materials using hot air, with adjustable temperature and optional time
mode. The air flap allows drying of wet material. The course of temperature is controlled by an up-
to-date microprocessor (Fuzzy-logic) with digital display and temperature sensor PT100. The set
provides high precision of temperature regulation and reliability of the tempering process.
The devices meet all and any legislative requirements and they are construed in compliance with
relevant EN standards – see the declaration of conformity. They are made of high quality materials
and using the most up-to-date technologies. Each individual piece is subject to careful output
control.

The Instructions for Use apply to the below stated

Models of devices:
Model Name Construction Note
design of the type
VC kkk-n ECO VENTICELL® Automatics ECO with real Foil keyboard
EC kkk-n ECO ECOCELL® time (for n = 2 automatics ECO U n=2 foil
IC kkk-n ECO INCUCELL® + EVO) keyboard +
ICV kkk-n ECO INCUCELL®-V touch screen
DC kkk-n ECO DUROCELL

where:
kkk – Chamber size 22, 55, 111, 222, 404, 707
n – Continuous version (–, 2).

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2.0 USE OF THE DEVICE
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Operation Qualification Page 4/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

2.1 SWITCHING THE DEVICE ON


The device is switched on by connection of the mains cable. Then, independent initialization
occurs. The activities of the device after initialization depend on its conditions before switch off:

• In case of the first switch on of the device or if no program was running before the switch off,
the device turns into the STOPPED condition,

• In case that the device was switched off while the program was running or a blackout occurred,
the device continues after initialization the program performance as from the moment when the
program run was interrupted.

2.2 CONTROL PANEL

Fig. 12

(1) Push button ON/OFF, (2) LED heating


• Light on – the device heating is active.
(3) Contextual keys
• Their meaning changes depending on the screen contents.
(4) Push buttons for horizontal and vertical movement in the menu
(5) Push button ESC
• Push button for return in one menu level back
(6) Push button OK
• Push button for action confirmation.
(7) LED indicating the device conditions – see 5
• Green – OK • Orange – warning • Red – error.
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3.0 USER INTERFACE
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Operation Qualification Page 5/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

3.1 HOME SCREEN (HOME)


3.1.1 HOME SCREEN IN STOPPED CONDITION

(1) Current temperature in the device chamber


(2) Device condition
(3) Additional information
(4) Clock – real time. Indicate by a blinking colon.

3.1.2 HOME SCREEN WHILE THE PROGRAM IS RUNNING

Fig. 14

(1) Current temperature in the device chamber


(2) Required temperature for current segment of the program
(3) Running program (4) Indication of active phase of the segment
(5) Icons symbolizing the activity of optional equipment of the device within given segment of the
program. In this case there is an internal socket in the chamber of the device.
(6) Fan revolutions for current segment of the program (7) Additional information
(8) Time data for current segment

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3.1.3 PROGRAM SCHEME AND TIME DATA FOR CURRENT SEGMENT
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Operation Qualification Page 6/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

The program of the ECO device is divided into segments. Within the scope of one
program it is possible to set 2 segments as a maximum. Each segment consists of
two parts:
• Start-up to required temperature.
• Regulation on temperature. The regulation on
Temperature may be „endless“ in case of the program to be set so. Graphic
representation of time data depends on active part of the current segment of the
program.

Displaying the time information in the course of the program:

Active part of current Style of time information Displaying in the scheme


segment of the program displaying of the running program
Segment start-up Small font of the time information.
Description „PASSED“.
Time is added.
„Endless“ regulation Small font of the time information.
on the temperature Description „PASSED“.
Time is added.
Regulation on the Large font of the time information.
temperature Time is counted down to zero.
Countdown up to delayed Large font of the time information. The scheme is replaced
start of the program Time is counted down to zero. with date and time of
delayed start.

3.2 MENU PROGRAMS

√ Home → Programs
The menu PROGRAMS serves for fast and comfortable start of selected program of the
device. In this menu it is also possible to view and edit parameters of programs.

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3.2.1 PROGRAM SELECTION
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Operation Qualification Page 7/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Programs

Fig. 15
(1) Selected program
(2) List of program parameters.
The selected program is started by pressing the right contextual push button START.
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3.2.2 PROGRAM EDITING


√ Home → Programs → Right Arrow
Enter the menu for program editing by pressing the contextual push button PROGRAMS.
Use the RIGHT ARROW push button to move in horizontal direction within the menu.
Press repeatedly the RIGHT ARROW (respectively UP ARROW, DOWN ARROW) push
button to enter the selected item editing. In the end of the editing process, the new
program parameters are saved using the contextual push button SAVE.

Fig. 16
(1) Edited program • P1 up to P9
(2) Program parameters (3) Edited segment (4) Possible values range (5) Edited item.

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3.2.3 PROGRAM PARAMETERS
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Operation Qualification Page 8/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

→ Program options

→ Number of program segments The ECO devices support programs with 1 or 2 segments.

→ Number of program cycles The ECO devices support 1 up to 99 cycles. There is also
supported endless cycling (setting „00“)

→ Way of program termination STOP: the program is automatically terminated after


it is finished.
∞ : the last segment of the last cycle of the program is endless.

→ Required temperature in chamber Supported units: °C, °F

→ Time of regulation at temperature Format hhhh:mm Min 00:00, Max 9999:59

→ Required fan revolutions Unit: % Min 10%, Max 100% Optimal regulation is reached at
100 %.

→ Electric socket in the chamber Possibility of switch on and off for the given segment of
the program.

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4.0 MAIN MENU
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Operation Qualification Page 9/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

4.1 DELAYED START

√ Home → Menu → Delayed Start


The delayed start of the program allows automatic start of the program in given time.

Fig. 17

√ Home → Menu → Delayed start → Date

Fig. 18

√ Home → Menu → Delayed start → Time

Fig. 19

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√ Home → Menu → Delayed start → Program
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Operation Qualification Page 10/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Fig. 20

The program with delayed start is activated by the right contextual push button START.
Information on delayed start of the program is displayed on the HOME screen:

Fig. 21

(1) Information on delayed start


(2) Time remaining to the program start

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4.2 PROGRAMS EDITING
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Operation Qualification Page 11/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Programs Editing


The menu serves for setting the program parameters. The editing process is performed as
described in. The menu also allows change of parameters of the currently running program.
The change is valid after pressing the contextual push button SAVE (Fig. 16) and return to
the HOME screen.

Fig. 22
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4.3 ALARMS
√ Home → Menu → Alarms
Alarms warn the user of the fact that regulated temperature got out of the pre-set limits.
There is set the allowed variation above and below the required temperature.

Fig. 23

• When the tolerance setting = 0, the alarm is inactive


• The running program may be stopped when an alarm occurs In case of the variation of real
temperature from required temperature to exceed the user-set limit and in case of such a
situation to last from more than1 minute, there is announced an alarm in the form of an error
message – warning.

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4.4 PROTECTIVE THERMOSTAT
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Operation Qualification Page 12/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Protective Thermostat


The protective thermostat serves for protection of exposed material, the device itself and its
surroundings in case of unexpected course of regulation or in case of a failure. The temperature in
the chamber is measured and assessed by an independent control block. When exceeding the
limits of the protective thermostat, the heating elements are disconnected from the mains and
the cabinet heating is stopped. Further procedures in case of temperature limits exceeding
depend on user setting of the switch PROGRAM STOPPING. See the table. Procedures in case of
exceeding the limits of the protective thermostat:

STOP THE PROCEDURE IN CASE OF EXCEEDING


PROGRAM THE TEMPERATURE LIMITS
Disconnection of heating elements. Exceeding the limits causes an error
announcement. In case of the event to occur while the program
is running, the running program is stopped immediately.
Disconnection of heating elements. Exceeding the limits causes a warning
announcement. In case of the event to occur while the program is running, the
program continues its activity (timing of segments, fan regulation, etc.), even
though the elements are blocked. After spontaneous return of temperature to
approved range, the temperature regulation is also restored according to the
program settings.

Fig. 24
√ Home → Menu → Protective Thermostat →Max. Temperature

Fig. 25

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4.5 EXPORT
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Operation Qualification Page 13/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Programs Export


The menu is active only in case of devices equipped with the USB Host interface, it allows
export of preset programs to a USB flash disk. Insert the USB flash disc to the connector on
the control panel. Export starts with contextual push button SELECT.

Fig. 26
The progress of the action is displayed on the display.

Fig. 27

Fig. 28

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4.6 IMPORT
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Operation Qualification Page 14/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Programs Import


The menu allows import of programs that were exported before (see 4.3.3.5), from the USB
flash disc. Insert the USB flash disc to the connector on the control panel, press contextual
push button SELECT, the course of the event is shown on the display.

Fig. 29
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4.7 SYSTEM INFORMATION

Fig. 30

• Type – device type


• S/N – serial number
• BATCH“ – number of programs passed.
• SW – firmware version

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5.0 MENU SETTINGS
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Operation Qualification Page 15/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings

Fig. 31
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5.1 DATE AND TIME
√ Home → Menu → Settings → Date and Time
The setting is preserved even after the device disconnection from the mains.

Fig. 32
√ Home → Menu → Settings → Date and Time → Date → Select

Fig. 33
√ Home → Menu → Settings → Date and Time → Time → Select

Fig. 34
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5.2 SETTING THE FAN IN THE DEVICE CHAMBER
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Operation Qualification Page 16/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → Fan


The menu in which it is possible to set the fan behavior after the program termination.
It is possible to select always one option within

Fig. 35
• Go on
o The fan goes on even after the program termination.
• Stop now
o The fan stops after the program termination.
• Stop after opening
o The fan stops after the program termination and
door opening.
• Stop below temperature
o The fan stops after the program termination and temperature drop below the specified limit.

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5.3 HEPA FAN SETTING
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Operation Qualification Page 17/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → HEPA fan


For devices equipped with the HEPA fan. The menu in which it is possible to set the HEPA fan
ventilator after the program termination. It is possible to select always one option within the
selection only.

Fig. 36
• Prohibited
o HEPA fan is inactive
• Go on
o The HEPA fan continues to run even after the program termination
• Stop immediately
o The HEPA fan stops after the program termination.
• Stop after opening
o The HEPA fan stops after the program termination and door opening.
o Only for devices with a door switch,
• Stop below temperature
o The HEPA fan stops after the program termination and temperature drop below the specified
limit.
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5.4 DOOR LOCK

√ Home → Menu → Settings → Door lock


Applies to devices with electromagnetic door lock mechanism. It applies to devices with
electromagnetic mechanism for door blocking. If the door locking is allowed, it is possible to
manually control the door lock any time by pressing and holding the appropriate combination
of keys, Together with manual control it is also possible to set automatic locking at the
moment of the device door closing.

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[[

Operation Qualification Page 18/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Fig. 37
• Allowed
o Door locking allowed – the door lock can be controlled by pressing and holding the appropriate
combination of keys,
• Automatic locking
o Doors are automatically locked after the delay time has elapsed (3 to 9 s).
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5.5 COMMUNICATION

√ Home → Menu → Settings → Communication


Menu allows you to set communication parameters for:
• connecting of device to the LAN
• serial port of device (RS232)
• USB (Device) in feet of the device

Fig. 38

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5.6 ETHERNET
[[

Operation Qualification Page 19/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → Communication → Ethernet

Fig. 39
• Mode
o Off
o Printer – for use with application Printer Archive
o WarmComm – for use with application WarmComm 4
• IP
o IP address assigned to the device
• Mask
o Mask of the network to which the device is connected
o Maximum value 255.255.255.252
• Gate
o The default gateway to the network to which the device is connected
5.7 SERIAL PORT
√ Home → Menu → Settings → Communication → Serial
RS232 connector is located in the foot of the device,

Fig. 40
• Off
• Printer
o For use with printer EPSON T20-II, see 4.3.4.6
• Printer Archive
o For use with application Printer Archive.
• WarmComm
o For use with application WarmComm 4

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5.8 USB
[[

Operation Qualification Page 20/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → Communication →USB


USB (device) connector is located in the foot of the device,

Fig. 41
• Off
• Printer Archive
o For use with application Printer Archive.
• WarmComm
o For use with application WarmComm 4.
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5.9 PRINT
The EPSON T20-II printer is used for protocol printing. Get the printer ready for operation
according to the instructions for use, connect the printer to the device using the RS232 cable,
In the communication setup menu, select Serial port printing,
√ Home → Menu → Settings → Communication → Serial → Printer

Set print parameters:


√ Home → Menu → Settings → Print

Fig. 42
• Print period
o 1 s to 24 h.
• Cut at the end of the program – automatically cutting the paper at the end of the program
• Printing of more information
o Additional information includes minimal, average and maximal value of the monitored quantity
in given interval, see Fig. 43
o Additional information is printed only in case of print period > 1 min to be set
o Extra temperature is printed only in case of the difference between max. and min. temperature
to be > 1°C (or equivalent in a pre-set unit).
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Operation Qualification Page 21/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Fig. 43
(1) Program heading
(2) Segment heading
(3) Segment start – start-up to temperature
(4) Current temperature in given time
(5) Minimal, average and maximal temperature recorded in the course of the print interval, see
also additional information printing (fig. 42)
(6) Segment start – regulation in temperature
(7) Extraordinary events recording
Notes:
• A new heading is printed in case of program parameters change.
• In case of power failure, the title “Power Failure” is printed after power supply restoration.

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6.0 PROTECTION
[[

Operation Qualification Page 22/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → Protection


In this menu it is possible to set passwords (respectively access combination of keys) for protected
access to some user respectively program settings and device controls.

Fig. 44

• DOOR UNLOCKING COMBINATION


o A combination of keys for manual unlocking of door at devices with electronic door blocking
function
o Initial settings: simultaneous pressing and holding of keys „↑“ and „↓“

• DOOR UNLOCKING PASSWORD


o Password for manual unlocking of door at devices with electronic door blocking function.

• PASSWORD FOR PROGRAMS EDITING


o Password for access to programs editing.

• Password for PT editing


o Password for access to protective thermostat setting

• PASSWORD FOR SETTINGS MENU


o Password for entry to the „Settings“ menu.

• KEYS LOCK COMBINATION


o Combination of keys for locking (unlocking) the keyboard.
o Initial settings: simultaneous pressing and holding
of keys „←“ and „→“.

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6.1 PASSSWORD EDITING
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Operation Qualification Page 23/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → Protection → Password…

Fig. 45
• Numeric code within the range 0 up to 9999
• Editing using the keys „↑“ , „↓“, „←“, „→“
• Password use for given item is deactivated by entering „- - - -„
Pre-set password confirmation is required after finishing the editing:

Fig. 46
6.2 KEYS COMBINATIONS
√ Home → Menu → Settings → Protection → Comb…

Fig. 47
• Combination of 2 or 3 keys
• Editing using the keys „↑“ , „↓“, „←“, „→“
• Keys combination use for given item is deactivated by entering "- - - -"
• Pre-set combination confirmation is required after finishing the editing.

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6.3 USER SETTINGS
[[

Operation Qualification Page 24/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → User Settings

Fig. 48
6.4 LANGUAGE
√ Home → Menu → Settings → User Settings → Language

Fig. 49
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6.5 SOUNDS
√ Home → Menu → Settings → User Settings → Sounds

Fig. 50
• End of Program
o Acoustic indication of the end of the program
• Error
o Acoustic indication of an error
• Push buttons
o Acoustic indication of a button pushing
• Open door
o Acoustic indication of door opening while the program is running.
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6.6 UNITS
[[

Operation Qualification Page 25/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → User Settings → Units

Fig. 51
Pass  Fail  N/A 

7.0 THE PROGRAM IS RUNNING

√ Home → Menu → Settings → User Settings → Info on the Main Screen

Selection of information to be displayed while the program is running in the field (7), Fig. 14. If you
select two or more items, the individual items will alternate (each of them displayed for the period
of 5 s).

Fig. 52

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7.1 TRANSITION TO ECONOMIC MODE
[[

Operation Qualification Page 26/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

√ Home → Menu → Settings → User Settings → Stand-by Mode

After expiration of pre-set time period as from the last push button pressing, the display turns
into stand-by mode. In this mode, display highlighting is switched off, current time is
displayed with large digits, see Fig. 54.

Fig. 53 Fig. 54

• Economic Mode.
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7.2 DOOR OPENING


In case of devices equipped with door limit switch warning on the device display indicates
door opening while the program is running. The event may also be acoustically indicated (see
4.3.5.2). In the course of opening, the fan revolutions are decreased to 10%.

Fig. 58

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7.3 USEFUL SPACE
[[

Operation Qualification Page 27/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Useful space is shown in Fig.1. Within the space delimited with bold lines in the figure (in
connection with standard DIN 12 880) there are met the temperature variations specified in
Chapter 6 – Device parameters. This lines show the inner walls of the chamber. That means
that values as per this chapter are not binding above the last upper tray.

Fig. 1

X(H) – 10 % of inner chamber depth


X(Š) – 10 % of inner chamber width
X(V)1 – distance between the lowest tray (shelf) and the inner chamber bottom
X(V)2 – distance between the uppermost tray (shelf) and the inner chamber ceiling

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EXECUTED BY / /
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7.4 CHARGE LAY-OUT IN THE CHAMBER
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Operation Qualification Page 28/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

The chamber charge should be placed in such a way so as not to significantly prevent air
circulation in the chamber – see Fig. 2 and Fig. 3. Minimal distance from the edge of inner
walls of the chamber is set by 10% of the given dimension: in depth X(H) and in width X(Š). It
is always necessary to distribute the charge evenly in the chamber, not to make any groupings
in one part of the chamber only – see Fig. 4 and Fig. 5. The chamber should be filled with the
charge in maximally 50% of the inner space.

Fig. 2

Fig. 3

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NAME DATE SIGNATURE


EXECUTED BY / /
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[[

Operation Qualification Page 29/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Fig. 4

Fig. 5

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Operation Qualification Page 30/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

8.0 TEST PROTOCOL


VENTICELL ECO Line
Sl.No. Tested Set Value Disp. Value Mea. Deviation Comm.
Value
1 Temperature (Set By User )
2 Stable time (30min)
3 Printing Interval

Comments:

8.1 TEST PROTOCOL


VENTICELL ECO Line
Sl.No. Tested Set Value Disp. Value Mea. Deviation Comm.
Value
1 Temperature (Set By User)
2 Stable time (30min)
3 Printing Interval

Comments:

Pass  Fail  N/A 

NAME DATE SIGNATURE


EXECUTED BY / /
VERIFIED BY / /
[[

Operation Qualification Page 31/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

9.0 MEASURING POSITION

One point temperature verification is executed with sensor placed in center of the chamber

Reference condition of the measurement: Ambient temperature 23 ± 2 ˚C

CERTIFIED CALIBRATION MEASUREMENT INSTRUMENTS

Description Model/Type Serial No. Certificate No. Valid up to


Digital Thermometer

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NAME DATE SIGNATURE


EXECUTED BY / /
VERIFIED BY / /
[[

Operation Qualification Page 32/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Section 10.0 PERSONNEL IDENTIFICATION


This document has been reviewed and approved after execution by the individuals listed below.
Note: at least double checks (reviews) by qualification company & three are required from user
side.
Side A: Qualification Company

1st review: The document has been reviewed after execution for correctness & completeness by:

Name & Surname *1: Initials:

Job Position:

Department Name & No.:

Company Name & Address:

Date:
Signature & Stamp:

2nd review: The executed document has been reviewed for correctness and completeness and
approved by:

Name & Surname *1: Initials:


Job Position:

Department Name & No.:


Company Name & Address:

Date:
Signature & Stamp:

*1: Including the academic title before the name and/or after the surname.
*2: The final execution approval is to be done by the “End User”. See next page.

Comments:
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Operation Qualification Page 33/33


Model: Venticell-404- ECO
Protocol and Report
“VENTICELL ECO Line” Serial No. H 182060
Dry Heat Sterilizer

Side B: End User


st
1 review: The prepared document has been reviewed for correctness and completeness by:

Name & Surname *: Initials:

Job Position:

Department Name & No.:

Company Name & Address:

Date:
Signature & Stamp:

nd
2 review: The prepared document has been reviewed for correctness and completeness by:

Name & Surname *: Initials:

Job Position:

Department Name & No.:

Company Name & Address:

Date:
Signature & Stamp:

rd
3 review: The prepared document has been reviewed for correctness and completeness and is finally
approved for execution by:

Name & Surname *: Initials:

Job Position:

Department Name & No.:

Company Name & Address:

Date:
Signature & Stamp:

Comments:

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