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Instruction Manual
Cristófoli, Brazilian importing company and manufacturer of health products
certified by ISO 13485 - Health Products - Quality Management System -
Requirements for Regulatory Purposes and compliance with RDC 16/2013 - *BPF -
Boas Práticas de Fabricação - ANVISA requirements.
CRISTÓFOLI'S MISSION
To 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 Bandeirantes in Campo
Mourão, Paraná, Brazil, manufactures biosafety equipment to assist the health care, having the following policy: "To develop
innovative solutions for health care by using agile, robust, and objective processes to better serve its customers. To fulfill all
the requirements of the applicable standards, promote the continuous improvement of its quality and environmental
standards, prevent pollution, reduce its environmental impact, and continuously train its staff, achieving, therefore, a
sustainable and profitable maximization of its value." Rev. 2.
*BPF: Brazilian standard similar to GMP - Good Manufacturing Practices (FDA / US)
13485
Vitale Class 12/21 Autoclave
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Summary of Contents for Cristofoli Vitale 21
- Page 1 Cristófoli, Brazilian importing company and manufacturer of health products certified by ISO 13485 - Health Products - Quality Management System - Requirements for Regulatory Purposes and compliance with RDC 16/2013 - *BPF - Boas Práticas de Fabricação - ANVISA requirements. 13485 Vitale Class 12/21 Autoclave CRISTÓFOLI’S MISSION...
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Page 2: Table Of Contents
CRISTÓFOLI INDEX Meaning of Symbols ............................ Introduction ..............................Intended Use ............................... Recommendations and Warnings ....................... How to Identify your Autoclave ........................Installation Instructions ..........................Automatic Altitude Adjustment ........................Safety Devices ............................. How to Use the Vitale Class CD Autoclave ....................Failure Indications ............................ -
Page 3: Meaning Of Symbols
CRISTÓFOLI MEANING OF SYMBOLS *Boas Práticas Keep out of Warning de Fabricação Sunlight 135 ºC Keep Dry Autoclavable ISO 13485 13485 Gorunding Alternating Current Recyclable Protection Terminal Dangerous Fragile - handle Lot number Electrical Tension with care Date of This side up Serial Number Manufacture Manufacturer... -
Page 4: Introduction
Never sterilize or heat foods. MANUFACTURER Responsible Technician Cristófoli Equipamentos de Biossegurança Ltda. Eduardo Luiz Soppa Rod. BR 158, nº127 - Campo Mourão - PR - Brasil. CREA-PR: 109201/D CEP 87309-650 CNPJ 01.177.248/0001 - 95 - Inscr. Est. 90104860-65 Website: www.cristofoli.com - e-mail: cristofoli@cristofoli.com... -
Page 5: How To Identify Your Autoclave
CRISTÓFOLI HOW TO IDENTIFY YOUR AUTOCLAVE The Identification label removal will cause automatic loss of warranty. IDENTIFICATION LABEL CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA ROD BR 158 Nº 127 - CAMPO MOURÃO - PR BRASIL - CEP 87309-650 - FONE: 55 44 3518-3432 CNPJ 01.177.248/0001-95 - INSCR. -
Page 6: Installation Instructions
CRISTÓFOLI INSTALLATION INSTRUCTIONS The equipment must always be carried by two people to prevent it from falling down. The storage/installation must be performed indoors, under room temperature, on a counter that can bear the weight of the autoclave. Install the autoclave in a room that is exclusive for sterilization. Install the autoclave on a flat, levelled and firm surface, and at a proper height for the operator to handle it (approximately 80 cm / 2.6 feet from the floor). -
Page 7: Automatic Altitude Adjustment
CRISTÓFOLI AUTOMATIC ALTITUDE ADJUSTMENT The performance of the autoclave is directly related to the atmospheric pressure, which varies according to the altitude of where is it installed. The following instructions will guide you on how to perform the Initial Cycle of your autoclave. -
Page 8: Safety Devices
CRISTÓFOLI SAFETY DEVICES The Vitale Class CD autoclave has the following safety devices: FUSE - This device protects the electrical installations and equipment against peaks of energy. The used fuse is the glass 6,35x32 AGLF, fast acting. If substitution is needed, see “Troubleshooting” (page 13). AUTOCLAVE AC VOLTAGE FUSE... - Page 9 CRISTÓFOLI Load the autoclave with the materials to be sterilized, be careful to not lean them against the chamber walls or internal steam exits, failure to follow these instructions may interrupt the sterilization cycle. Do not overload the autoclave. Do not exceed 75% of the chamber capacity (table 4).
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Page 10: Failure Indications
CRISTÓFOLI When the autoclave reaches the sterilization temperature/pressure, it will beep once and the LED will blink indicating the sterilization for 16 minutes (table 5). Obs.: for altitudes higher than 2000 m, the sterilization will last 20 minutes. If the autoclave does not reach the proper sterilization temperature in 40 minutes, by lack of water, excess of meterial or air leakage, the cycle will be automatically canceled. -
Page 11: Performing A New Initial Cycle
CRISTÓFOLI PERFORMING A NEW AUTOMATIC ALTITUDE ADJUSTMENT If the equipment is transferred to another place (building, city, state) perform the Automatic Altitude Adjustment again. To start this procedure again, follow the instructions below: With the autoclave on, open the door and, using a measuring cup, pour the correct amount of distilled water inside the chamber (150 ml for Vitale Class 12 or 250 ml for Vitale Class 21). -
Page 12: Quality Control
Peform biological test every 7 days. To obtain more information about how to perform the chemical tests, consult www.cristofoli.com at the session “Support” of your product or watch the video “Monitorização da Esterilização em Autoclaves – Parte II – Indicadores Biológicos” on www.youtube.com (CC available). -
Page 13: Troubleshooting
CRISTÓFOLI TROUBLESHOOTING For any replacement of parts, contact your local dealer or authorized technical assistance office. It’s not recommended the replacement by non-qualified people. Listed below are the most frequent problems and possible solutions, which could be solved by the user. THE AUTOCLAVE DOES NOT SWITCH ON POSSIBLE CAUSES SOLUTION... -
Page 14: How To Proceed When Service Is Needed
Always contact your local dealer. If you have problems contacting your dealer, contact us through our website: www.cristofoli.com. GUIDANCE FOR FINAL DISPOSAL OF THE EQUIPMENT The environment belongs to everyone, therefore, it is up to each one of us to make decisions that will help in its preservation and reduction of the damages resulting from human activities. -
Page 15: Warranty Terms
03 (three) months refer to the legal warranty (established by section II, art. 26, CDC, Brasil) and nine (09) months to the contractual warranty (arranged in art. 50, CDC, Brazil). Visit our website www.cristofoli.com and register your product online. -
Page 16: Use Instructions - Quick Guide
CRISTÓFOLI USE INSTRUCTIONS - QUICK GUIDE Read carefully the Instruction Manual 1. Connect the power cable to an outlet and press to turn the autoclave on. Open the door use the measuring cup to pour the correct amount of distilled water directly inside the chambe 150 ml for Vitale Class 12 and 250 ml for Vitale Class 21.
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