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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
Cristófoli Ultrasonic Cleaner
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 Ultrasonic cleaner
- Page 1 Devices - Quality Management System - Requirements for Regulatory Purposes, ISO 14001 - Environmental Management and *BPF - Boas Práticas de Fabricação - ANVISA. 13485 Cristófoli Ultrasonic Cleaner 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...
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Page 2: Table Of Contents
....................... Installation Instructions ..........................Components Identification .......................... Safety Devices ............................. Degassing / Using the Beaker ........................Heating ................................ How to Use the Cristófoli Ultrasonic Cleaner ....................echnical Data ............................How to Identify your Ultrasonic Cleaner ......................Preventive Maintenance ..........................Troubleshooting ............................ -
Page 3: Legend Of Symbols
CRISTÓFOLI U L T R A S O N I C C L E A N E R I N S T R U C T I O N M A N U A L LEGEND OF SYMBOLS Caution! Consult Good Manufacturing Keep away from accompanying... -
Page 4: Intended Use
Cavitation is the formation and collapse of millions of tiny little bubbles or cavities inside a liquid produced by the alternation of high and low pressure waves that are generated by the ultrasonic cleaner The bubbles appear in the water/solution and the effect of millions of implosions per second help the enzymatic detergent to break the molecules of dirt and contaminants, resulting in an efficient cleaning. -
Page 5: Installation Instructions
The storage must be done in a place protected from the weather action (indoors) in normal temperature conditions Install the ultrasonic cleaner in an exclusive sterilization room, ventilated and clean, on a flat, leveled and firm surface, a proper height for the operator to handle it Leave enough room next to the equipment for handling the instruments/articles. -
Page 6: Components Identification
CRISTÓFOLI U L T R A S O N I C C L E A N E R I N S T R U C T I O N M A N U A L COMPONENTS IDENTIFICATION Panel & Control keys Front View Transparent Lid Stainless Steel Vat... -
Page 7: Safety Devices
The Cristófoli Ultrasonic Cleaner may also be used to clean dental prosthesis like dentures, bridges or orthodontic devices like braces, etc., as shown by the Fig.6... -
Page 8: How To Use The Cristófoli Ultrasonic Cleaner
I N S T R U C T I O N M A N U A L HOW TO USE THE CRISTÓFOLI ULTRASONIC CLEANER For a better visualization, the drawings below do not show the lid. Remember to always use the lid when the equipment is in operation. - Page 9 CRISTÓFOLI U L T R A S O N I C C L E A N E R I N S T R U C T I O N M A N U A L Select the time desired on the panel using the key.
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Page 10: Technical Data
(Fig. 17) and dispose the solution into the sink. For a new cycle, wait 15 minutes and then follow the use instructions again. Fig.17 TECHNICAL DATA TECHNICAL DATA CRISTÓFOLI ULTRASONIC CLEANER 2,5 liters Total Capacity ................2,1 liters Useful Capacity ................ -
Page 11: How To Identify Your Ultrasonic Cleaner
The contaminated solution must be disposed according to the instructions DAILY of the topic “How to Use the Cristófoli Ultrasonic Cleaner”, instruction 10 (Page 10). After disposing the water/solution, remove the excess of residues that may have accumulated at the bottom of the vat with a soft sponge, cloth or even paper towels, then clean it with a soft... -
Page 12: Troubleshooting
•·The transducer burned out because of the lack of • See “Authorized Technical Assistance” (Page 13). water in the vat or incorrect voltage installation ----------- THE ULTRASONIC CLEANER TURNS ON BUT THE HEATING DOES NOT WORK POSSIBLE CAUSES SOLUTIONS •· The heating element has burned out ---------------------- See “Authorized Technical Assistance”... -
Page 13: Quality Control
CUSTOMER SERVICE DEPARTMENT - CSD In case you have doubts, complaints or suggestions, contact Cristófoli through the Customer Service Department - CSD by the e-mail: cac@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 14: 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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