Cristofoli Autoclave Baby User Manual
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.
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13485
Autoclave Baby
CRISTÓFOLI’S MISSION
Develop innovative solutions to protect life and promote health.
CRISTÓFOLI QUALITY AND ENVIRONMENTAL POLICY
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.
*BP F - Boas Práticas de Fabricação : Brazilian standard similar to the GM P - G ood Manufacturin g Practices ( FDA / US).
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
“Cristófoli. Valuing Life!”
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.
CSD - CUSTOMER SERVICE DEPARTMENT
Cristófoli Equipamentos de Biossegurança Ltda.
Rodovia BR-158, nº127, Campo Mourão, Paraná - Brasil.
CEP 87309-650
E-mail: cac@cristofoli.com
Docs/Layouts Informativos/Manual Baby/Baby Ing. Rev.1-2015
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CRISTÓFOLI
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INDEX
Legend of Symbols ......................................................................................................................................
Introduction .................................................................................................................................................
Important Safety Information .......................................................................................................................
Installation Instructions ..................................................................................................................................
Autoclave Components Identification .........................................................................................................
Safety Devices .............................................................................................................................................
Cycles and Messages .................................................................................................................................
Safety Notes .................................................................................................................................................
How to Use the Autoclave Baby ...................................................................................................................
Adverse Situations ........................................................................................................................................
Altitude Calibration ......................................................................................................................................
Technical Data ............................................................................................................................................
Time x Pressure Graphs ................................................................................................................................
Quality Control .............................................................................................................................................
How to Identify your Autoclave ....................................................................................................................
Troubleshooting ............................................................................................................................................
Preventive Maintenance ..............................................................................................................................
Preventive Maintenance Table ....................................................................................................................
How to Proceed When Service is Needed ...................................................................................................
Guidance for Final Disposal of the Equipment ............................................................................................
Warranty Terms .............................................................................................................................................
04
05
06
07
09
11
12
12
13
16
16
17
18
18
18
19
21
22
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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LEGEND OF SYMBOLS
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
135 ºC
~
4
Tinta
com propriedade
antimicrobiana.
Caution! Consult
accompanying
documents
Autoclavable
Alternate Current
Dangerous
Electrical Tension
Date of
manufacture
Manufacturer
Maximum
pile
Antimicrobial
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13485
*Boas Práticas
de Fabricação
ISO 9001
ISO 13485
ISO 14001
Grounding
Protection Terminal
Batch code
Serial Number
Painting
*BPF: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US)
Keep away from
sunlight
Keep dry
Recyclable
Fragile - Handle
with care
This side up
Fusible
Class ll
Equipment
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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
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.
24.The Warranty Terms can be found on Page
Box contents: 1 autoclave - 1 power cable - 1 envelope support - 1 measuring cup - 1 samples kit (hose and clamp) and
1 instruction manual.
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: cristofoli@cristofoli.com
Responsible Technician
Eder William Costa Camacho
CREA/PR – 87826/D
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IMPORTANT SAFETY INFORMATION
Before using your autoclave Baby, It is necessary to observe some safety measures. Autoclaves are pieces of
equipment which work at high temperature and pressure, therefore they must be handled by qualified and wellinformed 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, as well as articles and
instruments used in the aesthetics, beauty, manicure, podiatry, tattoo and body art areas resistant to the temperature of
121ºC and/o .r 135ºC, steam and pressure
ATTENTION! TO OPEN THE AUTOCLAVE
1 - Press the door forward; 2 - Lift the handle; 3 - Slide it to the left.
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 Not following this procedure may cause the door gasket to pop off Baby”, (Item c, page 13). .
When sterilizing instruments that have different autoclaving specifications simultaneously, as instruments that support
different levels of pressure (1.2 or 2.1 kgf/cm ) or temperature (121 or 135ºC) the operator must choose the cycle of
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lower temperature/pressure offered by autoclave.
When unlocking the handle, the autoclave door should open easily. Never force the door to open the autoclave!
When the door is opened at the end of the cycle to accelerate the cooling process, it is normal that some steam
comes out through the door.
IMPORTANT! Always make sure you unplug the equipment to perform any kind of maintenance (like simply
changing a fuse or performing an everyday cleaning).
We recommend reading this manual until it is fully understood. Keep it at hand and use it as a constant reference
source.
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CRISTÓFOLI
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INSTALLATION INSTRUCTIONS
The equipment must be always carried carefully 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 equipment.
Cristófoli Autoclave Baby 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 Cristófoli Authorized Technical Assistance. 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.
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
1
ou are going to install it. To do that, simply Check if the voltage of the autoclave is the same of the place where y
look at the identification label in the back of the autoclave. See “How to Identify your Autoclave” (Fig. 17, page 18).
2
For the installation use a grounded outlet (2P + T, 10A) connecting phase/neutral or phase/phase on the side pins
and grounding on the central pin (Fig. 2, page 8). Never connect the grounding on 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
installations and/or voltage.
3
Never use extensions, voltage transformers or any kind of adapters (Fig. 3, page 8).
4
For the proper functioning of your autoclave, the electrical voltage must be stable, in other words, without
oscillations Consult a professional electrician to check the electrical wiring in your building and make sure they are .
according to the specifications required It is mandatory the use of an exclusive circuit breaker for the outlet .
where you intend to install your autoclave. If after following all the specifications, the electrical current is still
oscillating, contact your local electricity company for repairs.
The electrical installation must follow the data from the table below.
MODEL
Baby - 127 V
Baby - 220 V
Note: In areas where voltage is 220V:
PP (Phase-Phase) use a “bipolar” breaker
PN (Phase-Neutral) use a “unipolar ” breaker connected to Phase.
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NOMINAL
CURRENT
6,3 A
3,7 A
CIRCUIT BREAKER VOLTAGE
1 Breaker 10 A.
1 Breaker 10 A.
127 V AC » 114 V - 140 V
220 V AC » 198 V - 242 V
WIRING GAUGE
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.
Table 1
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