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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 12
Summary of Contents for Cristofoli Vitale Class 12
- Page 1 ISO 13485 - Health Products - Quality Management System - Requirements for Regulatory Purposes and compliance with RDC 665/2022 - *BPF - Boas Práticas de Fabricação - ANVISA requirements. Vitale Class 12/21 Autoclave CRISTÓFOLI’S MISSION To develop innovative solutions to protect life and promote health.
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Page 2: Table Of Contents
CRISTÓFOLI INDEX Meaning of Symbols ............................Introduction ..............................Intended Use ..............................Recommendations and Warnings ......................... How to Identify your Autoclave ........................Installation Instructions ........................... Automatic Altitude Adjustment ........................Safety Devices ............................... How to Use the Vitale Class Autoclave ......................Failure Indications ............................Performing a New Automatic Altitude Adjustment ................... -
Page 3: Meaning Of Symbols
CRISTÓFOLI MEANING OF SYMBOLS Grounding Warning Recyclable Protection Terminal 135 ºC Fragile - handle Lot number Autoclavable with care Maximum Alternating Current Serial Number Pile Keep out of Dangerous Keep Dry Sunlight Electrical Tension Date of This side up Manufacture Manufacturer Fuse... -
Page 4: Introduction
Autoclaves work with high temperature and pressure, so must be handled by health care professionals, well aware of the equipment operation. Box content: 1 autoclave, 1 tray holder, 2 trays (Vitale Class 12) or 3 trays (Vitale Class 21), 1 cup, 1 hose (1,5 m), 1 clamp, and 1 manual. -
Page 5: How To Identify Your Autoclave
CRISTÓFOLI HOW TO IDENTIFY YOUR AUTOCLAVE The Identification label removal will cause automatic loss of warranty. IDENTIFICATION LABEL CLAMP FUSE HOLDER KEYBOARD EXTERNAL HANDLE STEAM EXIT CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA ROD BR 158 Nº 127 - CAMPO MOURÃO - PR BRASIL - CEP 87309-650 - FONE: 55 44 3518-3432 PANEL CNPJ 01.177.248/0001-95 - INSCR. -
Page 6: Installation Instructions
For distances up to 5 m (16 ft) from the circuit breaker to the outlet used to connect the equipment, use 2,5 mm wiring. From 5 to 15 m (16 to 46 ft) Vitale Class 12 9,5 A 15 A 127 V / 220 V use 4 mm, and from 15 to 50 m (46 to 164 ft) use 6 mm. -
Page 7: Automatic Altitude Adjustment
CRISTÓFOLI AUTOMATIC ALTITUDE ADJUSTMENT The performance of the autoclave is directly related to the atmospheric pressure, which varies according to the altitude of where is it installed. The following instructions will guide you on how to perform the Initial Cycle of your autoclave. -
Page 8: Safety Devices
AUTOCLAVE AC VOLTAGE FUSE 95 V - 254 V 10 A (250 V) Vitale Class 12 95 V - 254 V 15 A (250 V) Vitale Class 21 Table 2 DOOR KEY - Internal device that prevents the functioning of the equipment if the door is not properly closed. - Page 9 Do not overload the autoclave, the amount of articles to be sterelized must not exceed 1,2 kg for Vitale Class 12 liters, and 2,1 kg for Vitale Class 21 liters (table 3).
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Page 10: Failure Indications
CRISTÓFOLI When the autoclave reaches the sterilization temperature/pressure, it will beep once and the LED will blink indicating the sterilization for 16 minutes (table 4). If a cycle interruption/cancellation is needed, press . In this case, the LEDs Cancelado (Cancelled) and 0,5 kgf/cm²... -
Page 11: Performing A New Automatic Altitude Adjustment
During heating, the LEDs indicated at Fig. 12 will blink. The entire process is automatically performed. At the end of the process, the LED will indicate that the adjustment was successfully performed. TECHNICAL DATA CHART VITALE CLASS 12 VITALE CLASS 21 Capacity ............. 12 liters 21 liters Net weight ............ -
Page 12: Quality Control
Peform biological test every 7 days. To obtain more information about how to perform the chemical tests, consult www.cristofoli.com at the session “Support” of your product or watch the video “Monitorização da Esterilização em Autoclaves – Parte II – Indicadores Biológicos” on www.youtube.com (CC available). -
Page 13: Fuse Replacement
The non observing of this recommendation will cause loss of warranty of the autoclave. The used fuse is 6,35x32 AGLF Glass, Fast Action. For Vitale Class 12, use a 10 A (250 V) fuse, and for Vitale Class 21, use a15 A (250 V) fuse. -
Page 14: How To Proceed When Service Is Needed
Always contact your local dealer. If you have problems contacting your dealer, contact us through our website: www.cristofoli.com. GUIDANCE FOR FINAL DISPOSAL OF THE EQUIPMENT The environment belongs to everyone, therefore, it is up to each one of us to make decisions that will help in its preservation and reduction of the damages resulting from human activities. -
Page 15: 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, Brazil). Visit our website www.cristofoli.com and register your product online. -
Page 16: Use Instructions - Quick Guide
CRISTÓFOLI USE INSTRUCTIONS - QUICK GUIDE Read carefully the Instruction Manual 1. Connect the power cable to an outlet and press to turn the autoclave on. Open the door use the cup to pour the correct amount of distilled water directly inside the chambe r (pressure vessel), until the water reaches the "water level"...
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