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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
Cristófoli Distiller
CRISTÓFOLI'S MISSION
Develop innovative solutions to protect life and promote health.
CRISTÓFOLI'S 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 Distiller
- Page 1 ISO 13485 - Medical Devices - Quality Management System - Requirements for Regulatory Purposes, ISO 14001-Environmental Management and *BPF - Boas Práticas de Fabricação - ANVISA. 13485 Cristófoli Distiller CRISTÓFOLI’S MISSION Develop innovative solutions to protect life and promote health. CRISTÓFOLI’S QUALITY AND ENVIRONMENTAL POLICY Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº...
- Page 3 Thanks for choosing us. You, our clients, are the reason of Cristófoli's commitment. We put together this manual to guide you as best as possible, for the use and maintenance of your Cristófoli Distiller. We would like to thank all our customers and partners for helping us to continually improve and innovate our products and services.
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Page 4: Table Of Contents
Guidance for the Final Disposal of the Equipment............Links of Interest ......................Bibliographical References..................ATTENTION! READ ALL THE INSTRUCTIONS IN THIS MANUAL BEFORE USING YOUR CRISTÓFOLI DISTILLER. INCORRECT USE MAY RESULT IN DAMAGE TO THE EQUIPMENT AND/OR ACCIDENTS! -
Page 5: Introduction
The purpose of this manual is to familiarize you with the features and proper operation of your Cristófoli Distiller so you know how to take good care of it, as well as increase the equipment lifespan. It is important to know some aspects that can void this warranty as a result of negligence, improper use, non-authorized repairs, etc. -
Page 6: Legend Of Symbols
C R I S T Ó F O L I D I S T I L L E R I N S T R U C T I O N M A N U A L LEGEND OF SYMBOLS Caution, consult ISO 9001 accompanying documents Alternate Current... -
Page 7: Important Safety Information
Do not allow non-qualified people to handle the distiller, prevent patients and especially children to get close to the equipment; Make sure all the air openings for ventilation on the top of the distiller and on its sides are not obstructed;... - Page 8 In case a power outage occurs, the distiller will need to be manually reset to continue operation when energy is restored. To reset the distiller, press “OFF” on the “OFF/ON- Reset”...
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Page 9: Installation Instructions
INSTALLATION INSTRUCTIONS PHYSICAL INSTALLATION Install the distiller on a flat, leveled and firm surface, at a proper height for the operator to handle it. Leave enough room next to the distiller for handling and exchange of the water containers. Install the distiller in a ventilated and clean room, apart from the place where the patients are treated or people not qualified to operate the distiller may have easy access to it. -
Page 10: Safety Features And Devices
WATER LEVEL DEVICE - It is located in the back part of the main unit (Fig.7, item 12, page 12). The purpose of this device is to turn the distiller off automatically in the following cases: - the water in the tap water container is finished or its water exit is obstructed;... -
Page 11: Distiller General Features
(Fig.3, page 11); BASE UNIT - It works as a base for all the other parts of the distiller, it is made with heat resistant plastic, it is removable and easy to clean, (Fig.4, page 11);... - Page 12 C R I S T Ó F O L I D I S T I L L E R I N S T R U C T I O N M A N U A L Fig.2 Fig.5 Fig.6 Fig.3 Fig.4...
- Page 13 I N S T R U C T I O N M A N U A L WATER LEVEL DEVICE - It is located on the back of the main unit, it turns the distiller off automatically when the water from the tap water container finishes (Fig.7);...
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Page 14: How To Use The Cristófoli Distiller
Fill the tap water container with regular tap water, put the valve cap on and fit it on the base unit; 5. Allow a minute so the water fills the boiling tray. Plug the distiller into the electric outlet and press “ON-Reset” on the On/Off switch. At this moment, if the red LED is on, it means... - Page 15 Note. When the cooler is on, the distiller is heating, the water inside the device will reach 100 ºC and will be boiling. It will take from 3 to 5 minutes for the distiller to begin producing distilled water. In case the cooler is not running, check if all components are in place and press “On-Reset”.
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Page 16: Requirements To Be Observed For The Distillation Process
We suggest that the operator standardize the distillation process and prepare an estimate of the daily or weekly amount of distilled water needed, proceeding this way, the operator will know exactly how much water to distill, optimizing the use of the distiller. DISTILLED WATER STORAGE The storage of the distilled water must be done in a clean plastic or glass container properly closed and protected from light and heat. -
Page 17: Preventive Maintenance
70% or peracetic acid at 1%, make smooth movements in one direction only. It is important to clean the distiller internal parts (heating element, filter and boiling tray) regularly. The continuous use of the equipment will result in mineral deposits... -
Page 18: Troubleshooting
See “How to Proceed When Service Is Needed ” (Page 22); THE DISTILLER TURNS ON, BUT IT DOES NOT HEAT UP SOLUTIONS POSSIBLE CAUSES The heating element has burned out; In both cases, contact your local dealer or C r i s t ó f o l i d i r e c t l y t h r o u g h t h e e - mail:cristofoli@cristofoli.com. -
Page 19: Quality Control
HOW TO IDENTIFY YOUR DISTILLER The identification label is affixed on the right side of the equipment main unit. Its purpose is to identify the distiller technical data. ATTENTION! - Removing the Identification Label and/or any other stickers from the product will cause automatic loss of warranty. -
Page 20: Technical Data
I N S T R U C T I O N M A N U A L TECHNICAL DATA TECHNICAL DATA CHART CRISTÓFOLI DISTILLER CERTIFICATIONS............. This equipment is imported by Cristófoli, company which Quality Management System is certified and in accordance with the ISO 9001:2008, ISO 13485:2003, BPF- Boas Práticas de Fabricação - ANVISA (Brazilian... -
Page 21: Suggested Maximum Limits Of Contaminants In And Specification For Water For Steam Sterilization
C R I S T Ó F O L I D I S T I L L E R I N S T R U C T I O N M A N U A L SUGGESTED MAXIMUM LIMITS OF CONTAMINANTS IN AND SPECIFICATION FOR WATER FOR STEAM STERILIZATION Follows below part of the Table C.1 taken from the Standard 13060:2004, Annex C (Informative) with the suggested values for the water to be used in steam sterilization... -
Page 22: Warranty Certificate
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. Traveling costs (based on the distance traveled in km) and the stay of the authorized... -
Page 23: How To Proceed When Service Is Needed
(Fig. 7, item 13, page 12) and a description of the problem. It will be also necessary to have the original invoice from your dealer to confirm the date of purchase. -
Page 24: Links Of Interest
It is worth reminding you that your Cristófoli Distiller packaging, as indicated on the box label, is recyclable. Other items to be observed for the preservation of our planet: •... -
Page 25: Bibliographical References
C R I S T Ó F O L I D I S T I L L E R I N S T R U C T I O N M A N U A L BIBLIOGRAPHICAL REFERENCES APECIH- ASSOCIAÇÃO PAULISTA DE ESTUDOS E CONTROLE DE INFECÇÃO HOSPITALAR. Esterilização de Artigos em Unidades de Saúde.
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