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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
Autoclave Vitale Plus
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.
*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).
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Summary of Contents for Cristofoli Vitale Plus Series
- Page 1 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 Autoclave Vitale Plus CRISTÓFOLI’S MISSION...
- Page 3 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 Vitale Plus/Vitale Plus Ing.Rev.1-2015...
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Page 4: Table Of Contents
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 CONTENTS Legend of Symbols ............................Introduction ..............................Important Safety Information ........................Installation Instructions ..........................Autoclave Components Identification ...................... -
Page 5: 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 LEGEND OF SYMBOLS Caution! Consult *Boas Práticas Keep away from accompanying de Fabricação sunlight documents 135 ºC... -
Page 6: Introduction
- 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... -
Page 7: Important Safety Information
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 IMPORTANT SAFETY INFORMATION Before using your autoclave Vitale Plus, 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. -
Page 8: Installation Instructions
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 INSTALLATION INSTRUCTIONS 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. - Page 9 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 A T T E N T I O N ! VSPF VALVE (internal) AND AIR FILTER GROUNDING IS (external)
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Page 10: Autoclave Components Identification
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 AUTOCLAVE COMPONENTS IDENTIFICATION PANEL - It is located in the front part of the autoclave, It’s made with ABS injected plastic (Fig. 4, page 10). LID - Located right behind the panel, it’s made of stainless steel and it is responsible for closing the autoclave chamber (Fig. - Page 11 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 CHAMBER - Produced in anodized aluminum or stainless steel, the sterilization chamber is where the instruments/articles to be sterilized are placed (Fig.
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Page 12: Safety Devices
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 Vitale Plus 12 Base Sterilization Chamber Cover Fig. 12 Fig. 13 Inter nal steam exits Vitale Plus 21 Silicone pads Fig.11... -
Page 13: Cycles And Messages
(brand, model and software version) when the autoclave is turned on. Note: The software version may be updated at any time without prior notice. WHEN TURNED ON CYCLE OPTIONS UNWRAPPED plastics AND liquids 30 min cristofoli WRAPPED 10min 6min SURGICAL kit and COTTON 18 min vitale plus v0.0... -
Page 14: Safety Notes
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 SAFETY NOTES Warning! - During the autoclave operation, it is perfectly normal to hear some noises, some low, some loud. The noises are generated by the valves opening and closing, deaeration and depressurization, they are part of the proper functioning of the equipment. - Page 15 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 Close the door of the autoclave. To close it correctly, having the door open and the handle all the way to the left, close the door by pressing it against he chamber, slide the handle to the right, and then press it all the way down until it’s aligned with the panel (Figs.
- Page 16 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 Note: For the autoclave model Vitale Plus 21, when selecting the Surgical Kit cycle, the surgical case must be placed in the central tray.
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Page 17: Altitude Calibration
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 The table below provides information about the equipment heating time, sterilization temperature, pressure and time as well as drying time of each cycle and maximum drying temperature. -
Page 18: Adverse Situations
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 ADVERSE SITUATIONS Some situations may cause interruption and automatic cancellation of the cycle when: the ideal pressure/temperature is not reached due to steam/pressure leak, lack of water or overloaded chamber. -
Page 19: Technical Data
* In case the altitude and/or temperature of your workplace is different from the values mentioned in this manual, contact Cristófoli by the e-mail: cac@cristofoli.com. The manufacturer reserves the right to make changes and/or improvements to this product at any moment without prior notice. -
Page 20: Preventive Maintenance
For further information about how to perform the biological test in your autoclave, visit our site, www.cristofoli.com and go to your product support tab; - The autoclave will request the replacement of the air filter every 30 dias, the display will show the message: change air filter. -
Page 21: Preventive Maintenance Table
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 PREVENTIVE MAINTENANCE TABLE In order to help the operator to identify the several maintenance and monitoring procedures, we have organized them below in a table with their respective periodicity. -
Page 22: Time X Pressure Graphs
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 TIME X PRESSURE GRAPHS High Pressure Cycle Low Pressure Cycle Pressure x Time Pressure x Time Time (Min.) Time (Min.) -
Page 23: Troubleshooting
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 TROUBLESHOOTING ATTENTION! For any replacement of parts, contact your local dealer or the authorized technical assistance office. It’s strongly not recommended the replacement of any parts by non-qualified people. - Page 24 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 THE AUTOCLAVE PRESSURE GETS TOO HIGH, ACTIVATING THE SAFETY DEVICES SOLUTION POSSIBLE CAUSES •...
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Page 25: How To Proceed When Service Is Needed
Always contact your local dealer. If you have problems contacting your dealer, contact us by e-mail: cac@cristofoli.com or through our website: www.cristofoli.com. GUIDANCE FOR FINAL DISPOSAL OF THE EQUIPMENT The environment is something that belongs to everyone, therefore, it is up to each one of us to make the decisions that will help in its preservation and reduction of the damages resulting from human activities. -
Page 26: 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, Brasil). Visit our website www.cristofoli.com and register your product online.
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