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Installation Qualification Page 1/10

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

TABLE OF CONTENTS

1.0 INITIAL APPROVAL ...................................................................................................................... 2

2.0 PRODUCT NAME …………………………………………………..................................................................... 4

3.0 DEVICE DISCRIPTION ................................................................................................................... 5

4.0 PUTTING THE DEVICE INTO OPERATION ….................................................................................. 7

5.0 INSTALLATION AND OTHER CONDITIONS …………………................................................................9

6.0 Electricity Supply System ……………………………………………………………………………………………………...10

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Installation Qualification Page 2/10

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

1. INITIAL APPROVAL
This page serves as a statement that the appropriate individuals reviewed this document, determined
that it provides adequate detail about the device and its installation qualification and operation
qualification approved it for execution.
Note: at least double checks (reviews) by qualification company & three are required from user
side.
Side A: Device Qualification Company

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

Name & Surname *1: Initials:

Job Position:
Department Name & No.:

Company Name & Address:

Date:
Signature & Stamp:

2nd review: The prepared document has been reviewed for correctness and completeness and is
approved for execution *2 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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Installation Qualification Page 3/10

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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Installation Qualification Page 4/10

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

2.0 PRODUCT NAME

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 device models:
Type Model Trade Name Type Construction Design
VC-E VC ECO VENTICELL® Automatics ECO with real time (for n = 2
automatics ECO + EVO)

2.1 PURPOSE AND USE

ECOCELL® (EC) is used for materials tempering with hot air with natural circulation. The devices
are designed for temperatures up to 250°C and compared to VC devices they are characterized by
noiseless operation and lower electric power consumption.

DUROCELL (DC) is used for tempering with hot air with natural circulation (use for such processes
as acid hydrolysis, extraction on flame proof matters, hot decomposition), The devices are
designed for temperatures up to 125°C. The inner surfaces of the chamber are covered with a
layer of EPOLON, protecting the chamber from corrosive effects of acids in the form of steams or
liquids in case of their accidental leakage from closed vessels. For other important information see
the chapter “Putting the Device into Operation”.

VENTICELL® (VC) is used for materials tempering with hot air with forced circulation using a fan.
The devices are designed for temperatures up to 250°C, optionally up to 300°C. VENTICELL® may
also be used for sterilization, except for sterilization of medical devices in health service.

INCUCELL® (IC, ICV) serve as incubators or in microbiological laboratories for various cultures (see
chapter 12.14 Treatment against drying of substrata and tissue cultures). The devices are designed
for temperatures up to 70°C, optionally up to 100°C. The IC variant (without a fan) is characterized
by noiseless operation, the ICV variant (with a fan) is characterized by more precise temperature
regulation with small variation.

NAME DATE SIGNATURE

EXECUTED BY / /
VERIFIED BY / /
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Installation Qualification Page 5/10

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

3.0 DEVICE DESCRIPTION

3.1 GENERAL VIEW

Fig. 6

STANDARD VERSION

1 ECO regulator panel 9 PT100 temperature sensor case

2 Foil keyboard 10 Heating elements
3 Plastic cover of the regulator 11 Power section
4 Fan (only with types VC and ICV) 12 Power section
5 Air flap position control lever 13 Power section III (including the central
foot – only in three-phase version)
6 Admission port/suction inlet (with VC, ICV 14 Power cord (single-phase version)
types) with an air flap
7 Admission port/suction inlet (with EC, IC, DC 15 Door sensor (see the chapter Optional
types) Equipment).
8 Exhaust with air flap (all the types)

NAME DATE SIGNATURE

EXECUTED BY / /
VERIFIED BY / /
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Installation Qualification Page 6/10

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

3.2 MAINS CONNECTION AND CONNECTORS

Fig. 11: Devices feet – rear view

1 – USB connector, 2 – RS-232C (Canon) connector for printer, 3 – Mains supply
4 – Screws connecting the power section, 5 – Power section panel (placed in the foot).
Connect of cable for the printer EPSON T20-II:
Canon DB9 Female Canon DB25 Male
PIN Signal PIN Signal
2 RXD Receive Data 2 TXD Transmit Data
3 TXD Transmit Data 3 RXD Receive Data
4 DTR Data Terminal Ready 6 DSR DSR Data Set Ready
5 GND Signal Ground 7 GND Signal Ground
6 DSR Data Set Ready 20 DTR DTR Data Terminal Ready
1 FGND Frame Ground

The devices interconnected by the connector RS-232C must meet valid regulations from the point
of view of electric safety and electromagnetic compatibility.

Interface parameters: Baud 9600

Stop bit: 1
Parity: none
Data bit: 8
Communication interface
• Ethernet: 10/100 Mbps
interface 1 x RJ45
standard IEEE 802.3u
half/full duplex
• USB host: USB 2.0, full speed
• USB device: USB 2.0, full speed
• SD/MMC card: max. capacity 32 GB
• RS232:
– Printer connection: Baud: 9600
Stop bit: 1
Parity: none
Data bit: 8
Note:
Ethernet, SD card and USB Host are the optional equipment
of the device.
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Installation Qualification Page 7/10

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

4.0 PUTTING THE DEVICE INTO OPERATION

4.1 UNPACKING AND CONTROL

After unpacking please check whether the device and its accessories are complete and
undamaged. Any possible damage must be immediately reported to the carrier! Do not lift up the
case for the handrail or door in the course of handling (e.g. case lifting, etc.). Lift the case up using
the enclosed hooks. When removing the case from the palette take care of the device bottom. Lift
the case up using the hooks and move the palette completely out. When moving the case be
always very careful and handle the case in such a way so as not tip it over.

4.2 IMPORTANT WARNINGS

Read these Instructions for use carefully before starting the use of the device!

The device is transported to the client with evacuated chamber and that is why it is not
possible to open the door until the chamber is aerated. Fill the air into the chamber (see
chapter 7.4) to open the door. Do not open the door by force!

The unit is designed to work indoor within the ambient temperatures range of from 5°C
up to 40°C, at maximum relative humidity of 80%, up to the maximum altitude of 3,000
m.

Install the unit by plugging the power cord to the mains. However, make sure at first that
the mains parameters correspond to the values specified on the unit type label and to
the data shown in Chapter 4.2 – Electric installation and other conditions!

Minimum distance of the unit from the rear and side walls is 100 mm.
After the first switching-on of the unit the heating elements and insulation start to be
baked with a typical a smell; after a few operation cycles this smell disappears,
nevertheless it is suitable, during the insulation baking at a temperature above 100°C, to
secure a sufficient air exchange (e.g. by ventilation or exhaustion).
At temperatures above 100°C the inner chamber surface becomes yellowish. This
coloration is neither the material nor the device defect.
The load capacity of the floor for the device placement must correspond with the weight
of the device, taking into consideration the maximal charge weight (see chapter 4.1).
The device must not be placed on a mat that may induce a risk of fire or smouldering in
case of hot objects to fall out of the device.
It is not allowed to insert any flammable, explosive or poisonous substances or materials
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Installation Qualification Page 8/10

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

Do not put any corrosive materials into the devices.

The devices are not designed for environment with risks caused by flammable or
explosive substances
The unit is not designed to warm-up liquids and it contains no liquids.

In case of any manipulation with the unit, other than its normal use, or if you do not use it
for a longer period, disconnect it from electric mains by pulling the supply cord from the
socket.
Protection of the thermal cabinet, its surrounding and of the treated material against
inadmissible temperature rise is secured by the protection thermostat.

Maximum permissible load: see chapter 4.2.

Always place the material on shelves in the device, never put it on the bottom of the
device!

Do not put any object on the outer surfaces of the ovens.

The power supply plug (connection, cable) must not get in touch with hot parts of the
device.
Any assemblage and dismantling of any parts of the device may be performed only after
the device disconnection form electric power by pulling the line connector out of the
socket!

All and any installation conditions of the device can be found in tables, see chapter 4).

Devices connected via a communication interface must fulfil valid regulations from the
point of view of electric safety and electromagnetic compatibility.

If the device is used in another that specified way, the protection provided by the device
could be impaired.
NAME DATE SIGNATURE
EXECUTED BY / /
VERIFIED BY / /
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Installation Qualification Page 9/10

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

5.0 INSTALLATION AND OTHER CONDITIONS

Test Description VENTICELL ECO - 55-707 Liters

Yes No
1 Wrapping removal after putting the unit on the place of use
 
2 Visible transport damages
 
3 Stabilization of the unit
 
4 Connection to the mains See the warning!!!!!
 
5 Main switch switching-on. Control in the stand-by mode
 
6 Protocol Test Certificates
 
7 EC Certificates
 
8 Manuals
 
9 IQ & OQ Protocols
 

Pass  Fail  N/A 

NAME DATE SIGNATURE

EXECUTED BY / /
VERIFIED BY / /
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Installation Qualification Page 10/10

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

6.0 Electricity Supply System:

The validation specialist examines the electricity supply system of the installation room for
compliance with the requirements of the Device Manufacturer. The required parameter values
(column Required) are specified in the device’s OI manual (chapter “Parameters of the
apparatus’’), and can be also found in the type plate of the device. The actual parameter values
(column “Actual’’) can be found in technical documentation of the electricity supply system of the
installation room, and will be provided by the “Customer Representatives’’:

Electricity Supply System *¹ Required Actual Accepted

Voltage type  AC  Yes  No

 1 × 230  1 × 115
Phases x Voltage (between
phases) [V]  3 × 230  3 × 115  Yes  No

 3 × 230  ______

Voltage fluctuation *² [ %]: 10  Yes  No

Frequency range [Hz]  50  60  Yes  No

Protective Earth (PE)/ Neutral  PE  N  PEN  Yes  No

(N) / Combined (PEN) wire
Socket Protection:  16A (230V)  Yes  No
 32A (115V)  ___

MEASUREMENT INSTRUMENTS:

Description Present Absent Model/Type Serial No.

Digital AVO meter  

Pass  Fail  N/A 

NAME DATE SIGNATURE

EXECUTED BY / /
VERIFIED BY / /