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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 665/2022 - *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
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.
*BPF: Brazilian standard similar to GMP - Good Manufacturing Practices (FDA / US)
Vitale Class 12/21 Autoclave
Rua São José, 3209
, Área Urbanizada II in Campo
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Table of Contents
Related Manuals for Cristofoli Vitale Class 21
Summarization of Contents
Cristofoli's Mission
Mission Statement
To develop innovative solutions to protect life and promote health.
Quality and Environmental Policy
Company Policy Details
Policy for developing innovative solutions, improving quality, and minimizing environmental impact.
Meaning of Symbols
Symbol Definitions
Explains various safety, operational, and material symbols used on the autoclave.
Introduction and Usage
Manual Purpose
Indispensable for safe use and preventive maintenance orientation.
Intended Use
For sterilization of packed and unpacked heat-resistant articles using saturated steam.
Safety Recommendations
Important warnings and precautions for safe operation and maintenance.
Identify Your Autoclave
Autoclave Components Identification
Identifies key components of the Vitale Class autoclave through diagrams.
Installation Instructions
General Installation Guidelines
Guidelines for physical placement, handling, and room requirements.
Electrical Installation Requirements
Details on grounding, voltage, wiring, and circuit breakers for safe electrical setup.
Drainage Setup
Instructions on connecting the steam exit hose for proper drainage.
Automatic Altitude Adjustment
Performing Initial Altitude Adjustment
Step-by-step guide for the initial altitude adjustment cycle.
Re-performing Altitude Adjustment
When to perform a new altitude adjustment after relocation or maintenance.
Safety Devices
Safety Device Descriptions
Explanation of the autoclave's built-in safety features like fuse, door key, and valves.
How to Use the Vitale Class Autoclave
Connecting and Filling Water
Steps for connecting power and adding distilled water to the chamber.
Loading and Starting the Sterilization Cycle
Instructions on loading materials, closing the door, and initiating a sterilization cycle.
Cycle Process and Indicators
Explains cycle progression, LEDs, and audible signals during operation.
Drying and Post-Cycle Procedures
Steps for drying, cooling, and turning off the autoclave after a cycle.
Failure Indications
Interpreting Failure Codes
Lists LEDs and their corresponding causes for cycle cancellation.
Performing New Altitude Adjustment
Altitude Adjustment Steps
Detailed procedure to perform the altitude adjustment again.
Quality Control
Testing Procedures
Describes how autoclaves are monitored and tested using chemical and biological indicators.
Preventive Maintenance and Monitoring
Daily Maintenance
Procedures for daily external and internal cleaning of the autoclave.
Periodic Maintenance
Weekly, yearly, and 10-year maintenance tasks for optimal performance.
Fuse Replacement
Fuse Specifications and Replacement
Details on the correct fuse type and replacement procedure.
Troubleshooting Common Issues
Autoclave Not Switching On
Solutions for when the autoclave fails to power on.
Autoclave Not Heating
Solutions for when the autoclave powers on but does not heat.
Pressure Issues
Troubleshooting for excessive pressure or failure to build pressure.
Cycle Cancellation and Handle Stuck
Addresses issues like cycle cancellation and a stuck handle after depressurizing.
When Service is Needed
Contacting Support
Guidance on how to contact dealers or the manufacturer for service.
Equipment Disposal Guidance
Environmental Responsibility
Recommendations for environmentally responsible disposal of the equipment.
Warranty Terms and Conditions
Warranty Coverage Details
Details the warranty period, coverage, and exclusions.
Warranty Voidance Conditions
Lists conditions that will void the autoclave's warranty.
Quick Guide to Operation
Quick Operation Steps
A concise summary of the main steps for operating the autoclave.
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