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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 Quadra 54
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 Autoclave Quadra 54
- Page 1 Devices - Quality Management System - Requirements for Regulatory Purposes, ISO 14001 - Environmental Management and *BPF - Boas Práticas de Fabricação - ANVISA. 13485 Autoclave Quadra 54 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 Quadra 54/Quadra 54 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 Quadra 54 ......................Quality Control ............................. Adverse Situations ............................How to Identify your Autoclave ........................Time x Pressure Graphs .......................... -
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 hose (1,5 m) 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: Date And Time Setting
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 DATE AND TIME SETTING Whenever the autoclave is unplugged and reconnected, the system will prompt you to set the date and time by DATE/TIME? on the display. -
Page 8: Important Safety Information
CLOSE THE DOOR!. See “How to Use the Autoclave Quadra 54 ”, (Item b, page 14). When sterilizing simultaneously instruments that have different autoclaving specifications, as instruments that support different levels of pressure (1.2 or 2.1 kgf/cm ) or temperature (121 or 135ºC) the operator must choose the cycle of... -
Page 9: 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 three or four 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 10 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 ! Identification VSPF Valve (internal) Label GROUNDING IS CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA...
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Page 11: 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 CIRCUIT BREAKER - It is located in the back part of the autoclave, its function is to turn it on and off, as well as protect the equipment and building electrical wiring against peaks of energy or short circuits (Fig. - Page 12 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 EXTERNAL STEAM EXIT - Located in the back of the autoclave (Fig. 1, page 9), it has a diameter of 5/16” for the connection of the discharge hose, which is then connected to the plumbing system or proper container for this purpose.
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Page 13: 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 HEATING ELEMENT PROTECTOR - Cover made with stainless steel, it’s function is to isolate the heating element from the contents of the chamber (Fig. -
Page 14: Cycles And Messages
CYCLE OPTIONS WHEN TURNED ON WRAPPED 10 min plastics AND SURGICAL kit AND liquids 30 min cristofoli Quadra 54 v0.0 INSTRUMENTS COTTON 30 min FABRICS 30 min Note: This autoclave allows the software update through a USB flash drive. This procedure must be performed by a Cristófoli Authorized Technical Assistance Office. -
Page 15: Safety Notes
Cristófoli Equipamentos de Biossegurança Ltda, does not take any responsibility for failures and/or accidents caused by the non-observance of this warning. HOW TO USE THE AUTOCLAVE QUADRA 54 ATTENTION! Before starting a new sterilization cycle, make sure the reservoir has enough water to supply the autoclave need (at least 1,5 liters). - Page 16 At the end of the depressurization, the drying stage will begin automatically, the display will show the message drying and the temperature of the chamber. The autoclave Quadra 54 dries with the door closed. At the end of the drying process, the autoclave will beep 3 times and the display will show the message cooling. At this moment, the operator must open autoclave door and leave it ajar to accelerate the cooling process of the sterilized articles.
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Page 17: Quality Control
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 ATTENTION! Even after the beeps that indicate the conclusion of the cycle, the contents of the chamber will still be hot. Never touch the internal parts of the autoclave directly chamber, trays, materials, etc. -
Page 18: 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 Quadra 54” (Page 14). Before starting a new cycle, t he operator must check if there is water left in the chamber, which must be... -
Page 19: How To Identify Your Autoclave
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 In case of activation of one of the safety devices (sudden steam escape), generally caused by obstruction of the internal steam exit or by an obstruction of the solenoid valve, wait for complete depressurization before opening the p : 0.00 KGF/CM2. -
Page 20: 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 21: Preventive Maintenance
- Performing a biological test every 7 days , the display will show the message: 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; - and... -
Page 22: 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 23: Troubleshooting
• Press the Start key after selecting the cycle on the Mode key; didn’t press the Start key ------------------------------------------------------- • See “How to Use the Autoclave Quadra 54” (Page 14); • Nothing happens when the Start key is pressed -------------------------- •... - 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 TAKES TOO LONG TO BUILD UP PRESSURE OR DOES NOT KEEP IT, SHOWING THEN THE MESSAGE “CYCLE CANCELLED” POSSIBLE CAUSES SOLUTION •...
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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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