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Autoclave Quadra 54

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.

CRISTÓFOLI’S MISSION

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.

 

Develop innovative solutions to protect life and promote health.

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*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).

Summary of Contents for Autoclave Quadra 54

Page 1: ...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 requiremen...

Page 2: ......

Page 3: ...ance in the coordination of Crist foli s Biosafety Project complementary products research training of our employees representatives and technicians and as a lecturer of Biosafety Courses for professi...

Page 4: ...oclave Time x Pressure Graphs Technical Data Preventive Maintenance Preventive Maintenance Table Troubleshooting How to Proceed When Service is Needed Guidance for Final Disposal of the Equipment Warr...

Page 5: ...erminal Fusible Autoclavable Date of manufacture Boas Pr ticas de Fabrica o 4 P B F LOT SN Fragile Handle with care Dangerous Electrical Tension Serial Number Batch code Keep away from sunlight Recycl...

Page 6: ...for sterilization we recommend extra attention to this manual Autoclave sterilization although quicker and more efficient requires totally different procedures and handling while still keeping a simp...

Page 7: ...JAN 01 2009 The piece of information to be set will be flashing 3 Press MODE or CANCEL to set the data 4 Press START quickly to alternate the target information day month and year and keep it pressed...

Page 8: ...tem b page 14 When sterilizing simultaneously instruments that have different autoclaving specifications as instruments that support 2 different levels of pressure 1 2 or 2 1 kgf cm or temperature 121...

Page 9: ...red It is mandatory the use of an exclusive circuit breaker for the outlet where you intend to install your autoclave If after following all the specifications the electrical current is still oscillat...

Page 10: ...ification Label Power Cable Circuit Breaker Power Supply Buzzer V cut Hose for the external steam exit Keep it attached to the lid above the water level Use a lid with holes so the steam flows out Res...

Page 11: ...rs each It s located on the keyboard Fig 5 HANDLE Located in the right side of the autoclave panel Figs 8 and 9 page 11 It s used to open close and lock the autoclave door panel lid set To check the c...

Page 12: ...nents of the equipment responsible for the deareration depressurization and water supplying The valves open the beginning of the heating stage eliminating the cold air from the chamber then it shuts d...

Page 13: ...the equipment to the power outlet Fig 1 page 9 CLAMP Used to fasten the discharge hose to the external steam exit Fig 12 page 11 BUZZER Internal device used is to emit the beeps produced by the autoc...

Page 14: ...how many times the user has been notified about performing the biological test 5 Shows how many days ago and how many times the user has been notified about performing the preventive maintenance 6 Sho...

Page 15: ...alled in a proper and exclusive sterilization room Crist foli is not responsible for accidents that might occur due to the starts caused by the noises produced by the autoclave The symbol 14 appears i...

Page 16: ...from the flash drive to your computer simply insert it into the USB connection on your computer and copy the reports to a local folder and print them CRIST FOLI A U T O C L A V E S I N S T R U C T I...

Page 17: ...ry to speed up the cooling process of the instruments articles sterilized Upper view Note Heating time values are expressed considering the technical data chart Table 5 page 19 regarding the autoclave...

Page 18: ...when the ideal pressure temperature is not reached due to steam pressure leak or overloaded chamber In this case the cancellation will occur within 50 minutes at the most the sterilization cycle is i...

Page 19: ...N The removal of the identification label and or any other labels stickers affixed to the product will cause automatic loss of warranty Note The label presented here is just a sample model for your re...

Page 20: ...ce required for the movement of the door Chamber internal dimension W x D Autoclave external dimension W x H x D Dimensions of the trays W x H x D Clearance between the trays Voltage Frequency Power P...

Page 21: ...y Perform the preventive maintenance on the VSPF valve annually it consists of replacing the internal safety valve that comprehendsthe seal and pin Check the door locking system of the autoclave annua...

Page 22: ...L MAINTENANCE DAILY WEEKLY ANNUAL EVERY 10 YEARS External cleaning Preventive cleaning stainless steel chamber Door gasket cleaning Door gasket replacement Preventive Maintenance of the VSPF valve and...

Page 23: ...OT SWITCH ON THE AUTOCLAVE PRESSURE GETS TOO HIGH ACTIVATING THE SAFETY DEVICES Partial obstruction of the solenoid valve Defective electronic circuit Obstruction of the hose connected to the external...

Page 24: ...ance Page 20 Check the water level in the reservoir if necessary fill it up to the correct level Do not put more instruments than specified in each bag package Use up to 75 of the chamber s capacity t...

Page 25: ...ive Maintenance Item 8 page 20 Crist foli Equipamentos de Biosseguran a Ltda makes clear its concern already demonstrated by the implementation of the Environmental Management System according to stan...

Page 26: ...ssive exposure to sun light and salinity Sinister theft or robbery Improper use installation of the equipment and or plugging it into an incorrect voltage outlet Problems due to failure of the power s...

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