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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
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).
de Fabricação - ANVISA.
13485
Autoclave Baby
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Summary of Contents for Cristofoli Autoclave Baby
- Page 1 Devices - Quality Management System - Requirements for Regulatory Purposes, ISO 14001 - Environmental Management and *BPF - Boas Práticas de Fabricação - ANVISA. 13485 Autoclave Baby 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/Manual Baby/Baby Ing. Rev.1-2015...
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Page 4: Table Of Contents
Installation Instructions ..........................Autoclave Components Identification ......................Safety Devices ............................. Cycles and Messages ..........................Safety Notes ..............................How to Use the Autoclave Baby ........................Adverse Situations ............................Altitude Calibration ............................Technical Data ............................Time x Pressure Graphs ..........................Quality Control ............................. -
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
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
M A N U A L IMPORTANT SAFETY INFORMATION Before using your autoclave Baby, It is necessary to observe some safety measures. Autoclaves are pieces of 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 Autoclave Baby can be easily installed. Check if the wiring and voltage of your building are in accordance with the specifications below by consulting a professional electrician or Cristófoli Authorized Technical Assistance. See “Warranty Terms ”... - Page 9 INDÚSTRIA BRASILEIRA FUSE HOLDER FREQUÊNCIA - 50/60 Hz CONNECTION PIN 2 MODELO PIN 1 AUTOCLAVE BABY CAPACIDADE - REGISTRO ANVISA - 10363350005 POTÊNCIA CONFORMIDADE - NORMA NBR 11817 RESPONSÁVEL TÉCNICO Márcio Cyrilo Ribeiro - CREA/SP – 5062245952/D PRESSÃO MÁXIMA - PRODUTO: AUTOCLAVE CRISTÓFOLI PARA ESTERILIZAÇÃO A VAPOR.
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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 in the front part of the autoclave, made with ABS injected plastic, it is where the keyboard and display are located (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 SAFETY VALVE AND ANTI-VACCUM VALVE - The safety valve is one of the devices responsible for relieving the pressure inside the chamber in case it goes beyond the established limits.
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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 COVER - It is produced in carbon steel with textured electrostatic painting. The paint used (Nobak) has antimicrobial properties (Fig. -
Page 13: Cycles And Messages
(brand, model and software version) when the autoclave is turned on. WHEN TURNED ON CYCLE OPTIONS > 121°C 3 0 min. 121°C 3 0 min. cristofoli > Baby v 00 134°C 1 0 min. 134°C 1 0 min. MESSAGES... -
Page 14: How To Use The Autoclave Baby
I N S T R U C T I O N M A N U A L HOW TO USE THE AUTOCLAVE BABY Before using the autoclave for the first time, it is necessary to perform the altitude calibration procedure. - 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 Plug the autoclave in and press the START key, at this moment, the display will show the initial information (brand, °...
- Page 16 Upper view ATTENTION! When opening the autoclave for drying, observe the correct position of the door in the picture. The autoclave Baby dries with the door ajar, its opening is necessary to allow steam evaporation and provide an efficient drying process.
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Page 17: Adverse Situations
Check the possible causes, take the necessary measures to correct the problem and perform a new cycle to reprocess the articles according to the instructions on “ How to Use the Autoclave Baby” (Page 13). Before starting a new cycle, t he operator must check if there is water left in the chamber, which must be removed manually through the door with a clean and dry cloth that does not shed . -
Page 18: Technical Data
* In case the altitude and/or temperature of your workplace is different from the values mentioned in this manual, Table 6 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 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 GRAPHS Low Pressure Cycle High Pressure Cycle Pressure x Time Pressure x Time Time (Min.) Time (Min.) -
Page 20: Troubleshooting
• Press the Start key after selecting the program on the Mode key; • Nothing happens when the Start key is pressed -------------------------- • See “How to Use the Autoclave Baby ” (Page 13); • The heating element has burned out ---------------------------------------- •... - Page 21 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 SWITCHES ON, HEATS UP BUT THERE’S NO PRESSURIZATION SOLUTION POSSIBLE CAUSES •...
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Page 22: Preventive Maintenance
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 Some preventive procedures are necessary for the best functioning and durability of your autoclave, the preventive maintenance corresponds to the fulfilment of all procedures listed below: Use only distilled water Keep the autoclave clean. -
Page 23: 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 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.
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