Cristofoli vitale 12, vitale 21 Instruction Manual

CRISTÓFOLI’S MISSION

CRISTÓFOLI QUALITY AND ENVIRONMENTAL POLICY

Autoclave Vitale 12/21

Cristófoli, Brazilian company importer and manufacturer of health products

certified by ISO 9001 - Quality Management System, ISO 13485 - Medical

Devices - Quality Management System - Requirements for Regulatory Purposes,

ISO 14001 - Environmental Management and *BPF - Boas Práticas

de Fabricação - ANVISA.

13485

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*BP F - Boas Práticas d e Fabricação: Braz ilia n standard similar to the GMP - Good Manufacturing Practices (FDA / US).

Develop innovative solutions to protect life and promote health.

Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº 127, Jardim Curitiba in Campo
Mourão, Paraná, Brasil, manufactures biosafety equipment to assist the health field having as policy: “Develop innovative
solutions for the health field by using agile, robust and objective processes to better serve its clients. Fulfill the requirements
for regulatory purposes of the applicable standards, promote the continuous improvement of its quality and environmental
systems, prevent pollution, reduce its environmental impacts and continuous training of its employees, achieving this way, a
sustainable profitability and the maximization of the company’s value”. Rev. 2.

“Cristófoli. Valuing Life!”

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Docs/Layouts Informativos/Manuais/Manuais de Produtos/Autoclave Vitale/Manual Vitale 12/21 Ing. Rev. NV1-2015

CRISTÓFOLI

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I N S T R U C T I O N M A N U A L

Thanks for choosing us. You, our clients, are the reason of Cristófoli’s commitment.

We put together this manual to guide you as best as possible, in the use and maintenance of your Cristófoli Autoclave.

We would like to thank all our customers, partners and employees for helping us to continually improve and innovate our
products and services. Special thanks to Liliana J.P. Donatelli, Cristófoli’s Biosafety Consultant who provides a valuable
assistance in the coordination of Cristófoli’s Biosafety Project; complementary products research; training of our
employees, representatives and technicians; and as a lecturer of Biosafety Courses for professionals, academics and
assistants.

For any commentaries or suggestions about our products, please get in touch with our CSD - Customer Service
Department, through the address below.

Cristófoli Equipamentos de Biossegurança Ltda.

Rodovia BR-158, nº127, Campo Mourão, Paraná - Brasil.
CEP 87309-650
E-mail: [e-mail]

CSD - CUSTOMER SERVICE DEPARTMENT

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INDEX

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Introduction .................................................................................................................................................

Legend of Symbols ......................................................................................................................................

Important Safety Information .......................................................................................................................

Installation Instructions .................................................................................................................................

Autoclave Components Identification .........................................................................................................

Safety Devices .............................................................................................................................................

Safety Notes .................................................................................................................................................

How to Use the Autoclave Vitale ..................................................................................................................

Adverse Situations ........................................................................................................................................

Altitude Calibration ......................................................................................................................................

Technical Data ............................................................................................................................................

Time x Pressure Graphs ................................................................................................................................

Quality Control .............................................................................................................................................

How to Identify your Autoclave ....................................................................................................................

Preventive Maintenance ..............................................................................................................................

Preventive Maintenance Table ....................................................................................................................

Troubleshooting ............................................................................................................................................

How to Proceed When Service is Needed ...................................................................................................

Guidance for Final Disposal of the Equipment..............................................................................................

Warranty Terms .............................................................................................................................................

04
05
06
07
09
11
12
12
15
16
17
18
18
18
19
20
21
23
23
24

PLEASE, READ ALL THE INSTRUCTIONS IN THIS MANUAL BEFORE USING YOUR

AUTOCLAVE, INCORRECT USE MAY RESULT IN STERILIZATION FAILURE AND/OR ACCIDENTS!

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MANUFACTURER

Cristófoli Equipamentos de Biossegurança Ltda.

Rod. BR 158, nº127 - Campo Mourão - PR - Brasil

CEP 87309-650

CNPJ 01.177.248/0001-95 - Inscr. Est. 90104860-65

Website: www.cristofoli.com - e-mail: [e-mail]

Responsible Technician

Eder William Costa Camacho

CREA/PR – 87826/D

INTRODUCTION

This equipment was developed to assist you in the procedure of steam sterilization of articles/instruments by using steam
under pressure. We have intensively dedicated ourselves in order to guarantee your total safety. We hope in this way to
obtain your full satisfaction.

The purpose of this manual is to familiarize you with the features and proper operation of your autoclave so you know
how to take good care of it, obtain the best results in sterilization and drying, as well as increase the equipment's life span.

For those who have used only the dry heat sterilizer (Pasteur’s oven) for sterilization, we recommend extra attention to this
manual. Autoclave sterilization, although quicker and more efficient, requires totally different procedures and handling,
while still keeping a simple operation.

It is important to know some aspects that can jeopardize this warranty as a result of negligence, improper use,
unauthorized repairs, etc.

The Warranty Terms can be found on page 24.

: 1 autoclave - 1 power cable - 1 tray support - 2 trays (Vitale 12) - 3 trays (Vitale 21) - 1 measuring cup - 1 Box contents
samples kit (hose and clamp) and 1 instruction manual.

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LEGEND OF SYMBOLS

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I N S T R U C T I O N M A N U A L

Tinta

com propriedade

antimicrobiana.

~

This side up

Maximum

pile

Caution! Consult

accompanying

documents

Manufacturer

Alternate Current

Grounding

Protection Terminal

Fusible

Autoclavable

Date of

manufacture

*Boas Práticas

de Fabricação

4

P

B

F

LOT

SN

Fragile - Handle

with care

Dangerous

Electrical Tension

Serial Number

Batch code

Keep away from

sunlight

Recyclable

Keep dry

ISO 13485

ISO 14001

ISO 9001

13485

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Class ll

Equipment

Antimicrobial

Painting

135 ºC

*BPF: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US)

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WARNINGS!

Before sterilizing any articles, make sure you first check with their manufacturer if they are autoclavable (resistant to
the temperature of 135ºC and the presence of steam and pressure);

Do not allow patients or especially children to get close to the autoclave;
Install the autoclave in an exclusive sterilization room;

Never warm up or sterilize any kind of food in the autoclave;
Never make any kind of experiment with animals in the autoclave;
Never make any kind of use of this equipment other than the ones described in this manual.

SPECIAL MEASURES AND OBSERVATIONS DURING THE USE OF THE AUTOCLAVE:

Always make sure the door handle is properly locked before switching the autoclave on. See “How to Use the
Autoclave Vitale”, (Item c, page 13). Not following this procedure may cause the door gasket to pop off;

When unlocking the handle, the autoclave door should open easily. Always check for full depressurization, only the
first LED (position zero) of the indicative LEDs bar (Fig. 5, page 10) must be on. Never force the door to open the
autoclave!;

It is normal that some steam comes out through the door when it is opened at the end of the depressurization for
the drying stage;

Never touch the external steam exit (Fig. 1, page 8) and/or the internal surfaces of the autoclave (chamber, trays,
materials, etc.) during or right after operation, they will be very hot. Even after waiting for the materials to cool down,
it is recommended to use proper gloves to handle the sterilized materials. Improper use may cause burns,

Cristófoli is not responsible for incorrect procedures that may cause accidents;

In case of activation of one of the safety devices (sudden steam escape), generally caused by obstruction of the
steam exit internal orifice or by an obstruction of the solenoid valve, wait for the complete depressurization before
opening the door;

IMPORTANT! Always make sure you unplug the autoclave before performing any kind of maintenance like changing
the fuse or even the everyday cleaning;

We recommend reading this manual until it is fully understood. Keep it at hand and use it as a constant reference
source.

IMPORTANT SAFETY INFORMATION

Before using your autoclave Vitale, It is necessary to observe some safety measures. Autoclaves are equipment

which work at high temperature and pressure, therefore they must be handled by qualified and well-informed
personnel, regarding their features and functioning. It is essential for such qualification that the operators read all the
instructions carefully before using the autoclave to make sure to understand them correctly. The intended use of this
equipment is to perform sterilization on dental, medical and hospital instruments/articles resistant to the temperature of
135ºC, steam and pressure.

ATTENTION! TO OPEN THE AUTOCLAVE

1 - Press the door forward; 2 - Lift the handle; 3 - Slide it to the left.

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INSTALLATION INSTRUCTIONS

PHYSICAL INSTALLATION

Install the autoclave on a flat, leveled and firm surface at a proper height for the operator to handle it

(approximately 80 cm / 2.6 feet from the ground) Leave enough room close to the autoclave for the proper handling ).
of the materials to be sterilized Install the autoclave in a ventilated and clean place, apart from the room where the .
patients are treated The ideal place for the installation of the autoclave should be a separate sterilization room. .

Important! .Install your autoclave where it can be easily unplugged

ELECTRICAL INSTALLATION

Check if the voltage of the autoclave is the same of the place where it will be installed. To do that, simply look at

the identification label in the back of the autoclave. See “How to Identify your Autoclave” (Fig. 24, page 18).

For the installation use a 20A grounded outlet (3 pins) connecting phase/neutral or phase/phase on the side pins

and grounding on the central pin (Fig. 2, page 8). Never connect grounding to neutral.

ATTENTION As in any other electrical device, grounding is very important for the safety of the operator and the warranty !
of your equipment. Therefore, never remove or cut the plug’s central (grounding) pin off. Non-compliance with this

requirement may damage your autoclave. Cristófoli is not responsible for damages caused by inadequate
installation, voltage and/or electricity fluctuations.

(Fig. 3, page 8).Never use extensions, voltage transformers or any kind of adapters
For the proper functioning of your autoclave, the wiring voltage must be stable, in other words, without fluctuations.

Consult a professional electrician to check the electrical wiring in your building/workplace and make sure they are in
accordance with the specifications required. It is mandatory to use an exclusive circuit breaker for the outlet
where the autoclave will be installed. If after following all the specifications, the electrical current is still fluctuating,
contact your local electricity company for repairs.

The equipment must be always carried by two people to prevent it from falling or causing an accident. The
storage/installation must be done in a place protected from the weather action (indoors) in normal temperature conditions
on a counter that can bear the weight of the autoclave.
Cristófoli Autoclave Vitale can be easily installed. Check if the wiring and voltage of your building are in accordance with
the specifications below by consulting a professional electrician or your Cristófoli local dealer. See “Warranty Terms” (Page

24) and “How to Proceed When Service is Needed” (Page 23).
In case the end user chooses an unauthorized technician to install the autoclave, such technician should follow all the
guidelines described in the instruction manual for the physical, electrical and hydraulic installation of the equipment.
Cristófoli is not responsible for any services performed in disagreement with the instruction manual that accompanies the
product.

The electrical installation must follow the data from the table below.

Note: In areas where voltage is 220 V:

PP (Phase-Phase) use a “bipolar” breaker
PN (Phase-Neutral) use a “unipolar” breaker connected to phase.

1

2

4

3

7

Table 1

MODEL

NOMINAL

CURRENT

WIRING GAUGECIRCUIT BREAKER VOLTAGE

Vitale 12 - 127 V

10 A

6 A

127 V AC » 114 V - 140 V
220 V AC » 198 V - 242 V

For distance up to 5 m (16 ft) from the

circuit breaker to the outlet used to

connect the equipment, use 2,5 mm wiring.

From 5 to 15 m (16 to 46 ft) use 4 mm,

and from 15 to 50 m (46 to 164 ft) 6 mm.

1 Breaker 15 A.

1 Breaker 15 A.

Vitale 12 - 220 V
Vitale 21 - 127 V
Vitale 21 - 220 V

12 A

8 A

1 Breaker 10 A.
1 Breaker 20 A.

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