Cristofoli vitale 12 Instruction Manual

Cristofoli vitale 12 Instruction Manual

Autoclave
Hide thumbs Also See for vitale 12:

Advertisement

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 12/21
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).

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the vitale 12 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Summary of Contents for Cristofoli vitale 12

  • Page 1 Devices - Quality Management System - Requirements for Regulatory Purposes, ISO 14001 - Environmental Management and *BPF - Boas Práticas de Fabricação - ANVISA. 13485 Autoclave Vitale 12/21 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...
  • 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/Manuais/Manuais de Produtos/Autoclave Vitale/Manual Vitale 12/21 Ing. Rev. NV1-2015...
  • 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 INDEX Introduction ..............................Legend of Symbols ............................Important Safety Information ........................Installation Instructions ..........................Autoclave Components Identification ......................
  • Page 5: Introduction

    The Warranty Terms can be found on page 24. Box contents : 1 autoclave - 1 power cable - 1 tray support - 2 trays (Vitale 12) - 3 trays (Vitale 21) - 1 measuring cup - 1 samples kit (hose and clamp) and 1 instruction manual.
  • Page 6: 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 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, 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

    WIRING GAUGE CURRENT 1 Breaker 15 A. 10 A Vitale 12 - 127 V For distance up to 5 m (16 ft) from the circuit breaker to the outlet used to 1 Breaker 10 A. Vitale 12 - 220 V 127 V AC »...
  • 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 ! GROUNDING IS ESSENTIAL Bipolar plug and wall socket with grounding EXTERNAL STEAM...
  • Page 10: Autoclave Components Identification

    (Fig. 14, page 11). TRAYS - Provided are 2 trays for Vitale 12 (Fig. 13, page 11) and 3 trays for Vitale 21 (Fig. 15, page 11), to keep the instruments to be sterilized free from any direct contact with the water and internal surface of the autoclave chamber.
  • Page 11 Fig. 5 Drying key Start key Fig. 4 Safety Valve Anti-Vacuum Valve Detail Detail Door Gasket Fig. 6 Fig. 7 250 ml Vitale 21 200 ml 150 ml Vitale 12 Fig. 9 100 ml Baby Fig. 10 50 ml Fig. 8...
  • 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 12 Base Sterilization Chamber Cover Fig. 12 Fig. 13 Vitale 21...
  • Page 13: 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 THERMOSTAT - Internal safety device of the equipment. Its function is to limit the excessive heating of the chamber during the sterilization cycles or in case a circuit board malfunction occurs.
  • Page 14 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 Load the autoclave with the materials to be sterilized, be careful not to lean them against the chamber walls or internal steam exits, that will cause interference in the cycle and damages to the articles.
  • 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 Pressure variation range As soon as the ideal temperature for the sterilization is reached, the during the sterilization stage autoclave will begin the sterilization stage, it will beep once and the (from 1.7 to 1.8 kgf/cm / 167 to 177 kPa)
  • Page 16: Adverse Situations

    The table below provides information regarding the autoclave programs. Sterilization Cycles Heating Sterilization Drying Temperature and Pressure Vitale 12/21 Time Time Time Single cycle 10 to 60 min. 126 to 129 ºC / (1.7 to 1.8 kgf/cm ) 16 min.
  • Page 17: Altitude Calibration

    Open the door of the autoclave, use the measuring cup to add the correct amount of distilled water directly into the chamber before each cycle (150 ml for Vitale 12 or 250 ml for Vitale 21); Press and hold the START and DRY keys simultaneously and plug the autoclave in;...
  • Page 18: Technical Data

    Note 1: 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. Note 2: The manufacturer reserves the right to make changes and/or improvements to this product at any moment without prior notice .
  • Page 19: 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 GRAPH Pressure x Time Time (Min.) Graph 1 QUALITY CONTROL Cristófoli equipment are tested and monitored individually, according to the parameters of the Table 5 (Page 15).
  • Page 20: Preventive Maintenance

    Replace the internal hoses annually; Biological tests and preventive maintenance: The autoclave Vitale 12/21 requires the fulfillment of some very important procedures for the sterilization: - A biological test must be performed every 7 days. 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;...
  • 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: 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 23 Use up to 75% of the chamber's capacity, that means, 5 envelopes for Vitale 12 or 13 envelopes when using the support. The model Vitale 21 can hold 12 envelopes or 13 with the support, it can also hold 2 supports simultaneously, allowing the sterilization of 26 envelopes at a time (envelopes 10 x 23 cm containing 6 instruments each).
  • Page 24: 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 25: 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.

This manual is also suitable for:

Vitale 21

Table of Contents