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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.
13485
SuperGap Evolution 2
Vacuum Pump

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Summary of Contents for Cristofoli SuperGap Evolution 2

  • Page 1 Quality Management System - Requirements for Regulatory Purposes and compliance with RDC 16/2013 - *BPF - Boas Práticas de Fabricação - ANVISA requirements. 13485 SuperGap Evolution 2 Vacuum Pump CRISTÓFOLI’S MISSION To develop innovative solutions to protect life and promote health.
  • Page 2: Table Of Contents

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L INDEX Meaning of Symbols ......................Introduction ........................
  • Page 3: Meaning Of Symbols

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L MEANING OF SYMBOLS Warning ISO 13485 13485...
  • Page 4: Introduction

    The SuperGap Evolution vacuum pump must be handled by professionals, well aware of the equipment operation. Box content: - 1 Supergap Evolution 2 Vacuum Pump. - 1 noise reducer. - 1 residue filter. - 4 leveler glides with nuts and washers.
  • Page 5: Installation Instructions

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L INSTALLATION INSTRUCTIONS Instal vacuum pump on a flat, levelled and firm surface, at the same level or below the dental unit, never above.
  • Page 6 C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L WIRING GAUGE FROM THE CIRCUIT BREAKER UP TO THE VACUUM PUMP (mm²) CIRCUIT BREAKER POWER Up to15 m...
  • Page 7 C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L DRAINAGE The one-way noise reducer minimizes the noise produced by the airflow inside the pipe. The vacuum pump induces air to the plumbing system, so open drains or siphons near will release air, noise and probably bad smell, therefore, every drain at the establishment must have a siphon.
  • Page 8 C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L Table of dimmensions for pipes from the vacuum pump to the dental unit. Pipes length* Pipes diameter Model...
  • Page 9: Safety Devices

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L SAFETY DEVICES FUSE - Internal device, located at the electronic circuit (glass model - fast acting - 300mA), that protects the electrical installations and equipment against peaks of energy (Fig.
  • Page 10: How To Identify Your Autoclave

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L HOW TO IDENTIFY YOUR AUTOCLAVE The identification label, located at the CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA ROD BR 158 Nº...
  • Page 11: Preventive Maintenance

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L PREVENTIVE MAINTENANCE For better functioning and durability of your vacuum pump, some procedures are needed.
  • Page 12: Troubleshooting

    C R I S T Ó F O L I V A C U U M P U M P 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 yout local dealer. It’s not recommended the replacement by non-qualified people.
  • Page 13: Quality Control

    (Fig. 6, page. 8) and a description of the problem. Always contact your local dealer. If you have problems contacting your dealer, contact us through our website: www.cristofoli.com.
  • Page 14: Guidance For Final Disposal Of The Equipment

    C R I S T Ó F O L I V A C U U M P U M P S I N S T R U C T I O N M A N U A L 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

    (provided it contains the serial and lot numbers of the equipment), of which 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.

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