Cristofoli Distiller Manuel utilisateur

CRISTÓFOLI’S MISSION

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.

CRISTÓFOLI’S QUALITY AND ENVIRONMENTAL POLICY

Develop innovative solutions to protect life and promote health.

Cristófoli Distiller

*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good

Manufacturing Practices (FDA / US).

13485

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.

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.

Special thanks to Liliana J. P. Donatelli, Cristófoli’s Biosafety Consultant who provides us

a valuable assistance in the coordination of the Cristófoli's Biosafety Project,

complementary products research, our employees, representatives and technicians’

trainings, and as a lecturer of Biosafety Courses for professionals, academics and

assistants.

For any complaints or suggestions about our products, please get in touch with our

CSD - Customer Service Department, through the address below.

“Cristófoli. Valuing life!”

Cristófoli Equipamentos de Biossegurança Ltda.

Rodovia BR-158, nº127, Campo Mourão, Paraná - Brasil.

CEP 87309-650

E-mail: cac@cristofoli.com

CSD - CUSTOMER SERVICE DEPARTMENT

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Documentos/Layout Informativos/Manual Destilador Cristófoli/Destilador Cristófoli Inglês - Rev.5

Introduction.................................................................................................................

Legend of Symbols.....................................................................................................

Important Safety Information.......................................................................................

Installation Instructions.................................................................................................

Safety Features and Devices.......................................................................................

Distiller General Features.............................................................................................

How to Use the Cristófoli Distiller...................................................................................

Requirements to Be Observed for the rocessDistillation P ............................................

Possible Failures...........................................................................................................

Preventive Maintenance.............................................................................................

Troubleshooting...........................................................................................................

Quality control.............................................................................................................

How to Identify your Distiller..........................................................................................

Technical Data ...........................................................................................................

Suggested maximum limits of contaminants in and specification for water for

steam sterilization .......................................................................................................

Warranty Certificate.....................................................................................................

How to Proceed When Service is Needed..................................................................

Guidance for the Final Disposal of the Equipment......................................................

Links of Interest ...........................................................................................................

Bibliographical References........................................................................................

ÍNDICE

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!

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INTRODUCTION

This equipment was developed to assist you in the important procedure of distilling

water to be used in steam sterilization autoclaves or any other application where it is

necessary to use distilled water. We dedicated ourselves intensively to guarantee you the

highest quality and safety. We hope to obtain this way, the highest level of satisfaction from

our clients.

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.

You will find the Warranty Certificate on page 21.

Responsible Technician

Eder William Costa Camacho

CREA/PR – 87826/D

IMPORTER

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: [email protected]

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LEGEND OF SYMBOLS

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Fragile

Handle with Care

This Side Up Serial Number

Batch Number

Keep Away from

Sunlight

Recyclable

Maximum Pile

Caution, consult

accompanying documents

Manufacturer

Alternate Current

Keep Dry

ISO 13485

ISO 9001

ISO 14001

Date of

Manufacture

LOT

Caution

Hot Surface

13485

IMPORTANT SAFETY INFORMATION

The intended use of this equipment is to distill water to be used in steam sterilization

autoclaves or any other application where it is necessary to use distilled water. In order

to determinate the quality of the water obtained with the use of the Cristófoli Distiller,

we have used the reference parameters found on the Table C.1 from the Standard EN

13060, Annex C “Suggested maximum limits of contaminants in and specification for

water for steam sterilization” (Page 20). In some specific cases, it may be necessary

that the water is purified by special processes. Check whether the parameters

obtained satisfy your needs. It is essential that the operator reads attentively all the

instructions before using the distiller to make sure they are correctly understood.

WARNING! To perform any kind of maintenance or everyday cleaning, always make

sure to unplug the equipment and wait at least 30 minutes for it to cool down before

handling. Improper use may cause burns. Cristófoli is not responsible for incorrect

procedures that may cause accidents;

We recommend reading this manual until it is fully understood. Keep it at hand and

use it as a constant reference source;

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;

As a routine, make sure all the distiller components are properly fitted before using it.

Non-observance of this procedure may interfere in its correct functioning. See “How to

Use the Cristófoli Distiller ” (Page 13);

Never put any liquid in the distiller other than regular tap water (potable water

provided by the urban water system) or filtered water, do not perform any use of this

equipment other than the one described in this manual.

Note: The use of filtered water reduces the formation of scales (deposits of mineral

crusts) on the heating element and makes cleaning easier;

SAFETY STEPS TO PROPERLY OPERATE YOUR CRISTÓFOLI DISTILLER

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Never remove the main unit or touch the boiling tray while the distiller is on.

Never place your distiller near any heat source (electric heaters, gas ovens, etc);

Never use extensions, voltage transformers or any kind of adapters, do not plug the

distiller into inappropriate voltage outlets;

When the Distiller is not in use, disconnect the power cable from the outlet;

When the main unit is lifted or tilted, the distiller will turn off automatically;

When the water in the tap water container empties and the water level in the boiling

tray falls to the minimum pre-set point, the distiller will shut off automatically;

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” switch, wait for about 3 seconds until the red LED turns off, then, press “ON-

Reset”.

Note: In case the “OFF/ON-Reset” switch is returned to “ON-Reset” before the red LED

turns off, the distiller will not work.

WHEN THE LED FLASHES - When the LED flashes during operation it is indicating that

scale deposits have formed on the filter, boiling tray and heating element. These parts

should be cleaned with white vinegar or lemon vinegar (see “Preventive

Maintenance” (Page 16).

The distiller will also stop working automatically in case the process takes longer than 8

hours. Clean the filter, boiling tray and the heating element as mentioned above.

When continuous cycles are desired push the reset button once to override the 8-hour

time limit.

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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.

Important! Install your distiller where it can be easily unplugged. This is the proper

way to turn the equipment off completely.

ELECTRICAL INSTALLATION

The voltage of the distiller is 127V or 220V, as informed on the identification

label located on the right side of the distiller main unit (Fig.2, page 11 and

Fig.7, page 12). Make sure the wiring where it will be installed is in voltage

accordance with the value marked on the Identification Label. Attention! Non

compliance with this requirement may damage your equipment. Cristófoli

is not responsible for damages caused by inappropriate installations and/or

voltage.

For the installation, use a three pin outlet, (2P + T, 10A), with grounding pin (Fig.

1, page 9);

Never use extensions, voltage transformers or any kind of adapters.

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INSTALLATION INSTRUCTIONS

The electrical installation must follow the data from the table below:

Your Cristófoli Distiller has the following safety devices:

SAFETY FEATURES AND DEVICES

THERMAL FUSE (equipment internal device) - There is a thermal fuse attached to

the heating element. Its function is to limit equipment overheating during

operation. If the thermostat fails, the thermal fuse will be activated to cut the

current safely;

THERMOSTAT - (equipment internal device) - Its function is to limit equipment

excessive heating during operation;

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;

- the tap water container is removed;

After filling the tap water container, the distiller must be reset. Press “OFF” on the

On/Off Switch to and then back to “ON-Reset”;

When the distiller is tilted or lifted it will shut off automatically.

Outlet and plug with grounding pin

(three pins or 2P + T) 10A.

MODEL AMPERAGE

VOLTAGE

Cristófoli Distiller 127 V~ - - - - - - - - - - - 4,3 A

220 V~ - - - - - - - - - - - 2,2 A

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Fig.1 Fig.1A

Table des matières

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