Cristofoli Distiller User manual

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
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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.

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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: [e-mail]
CSD - CUSTOMER SERVICE DEPARTMENT
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Documentos/Layout Informativos/Manual Destilador Cristófoli/Destilador Cristófoli Inglês - Rev.5

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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
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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
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Caution
Hot Surface
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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

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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

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MAIN UNIT - Upper part of the equipment made with injected ABS plastic where the
heating element, cooler and On/Off Switch are located (Fig.2, page 11and Fig.7,
page 12);
ON/OFF SWITCH - It is in the front side of the main unit (Fig.2, page 11), its function is to
turn the distiller on and off, it also works as “RESET” button;
PREHEATING AREA - Area located around the boiling tray, it allows the pre-heating of
the water (Fig.3, page 11);
BOILING TRAY - Made with heat resistant plastic, it is where the boiling actually occurs,
it is removable and can be easily cleaned, manually or in a dish washer (Fig.3, page
11);
WATER LEVEL TRAY - Its purpose is to contain the water to be distilled, (Fig.3, page 11);
WATER TRAY - Attached on the base unit, it holds the tap water container and the
water to be distilled (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);
TAP WATER CONTAINER - Fitted in the back part of the distiller, it stores the tap water to
be distilled, it is removable and can be easily filled under the tap, (Fig.5, page 11);
TAP WATER CONTAINER CAP WITH SPRING VALVE - Special cap that acts as a valve for
the water in the tap water container, (Fig.5, page 11);
CARBON FILTER - When the water is to be used for human drinking (considering that
distilled water loses minerals during the distillation process), fit the carbon filter on the
distilled water container entrance for extra fresh tasting water (additional carbon filters
are available for purchasing), (Fig.6, page 11);
DISTILLED WATER CONTAINER - It is the frontal square container where the distilled
water is stored, it has a cap and can be put in the refrigerator to cool the water, (Fig.6,
pág.11);
DISTILLER GENERAL FEATURES
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Fig.2
Fig.3
Fig.4
Fig.5
Fig.6
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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);
IDENTIFICATION LABEL - Affixed on the right side of the main unit its function is to ,
identify the distiller technical data (Fig.7);
POWER CABLE - Used to connect the equipment to the electric outlet, (Fig.7).
FILTER - It is used to reduce scales (mineral deposits) build-up on the heating element
to ensure maximum heating efficiency and performance of the distiller. It must be
replaced every other 3 months, additional filters are available for purchase, (Fig. 7);
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Fig.7
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1. Remove the distiller from the box;
Note: it is useful to keep the original box, it can be used later in case you need to return the
device to the distributor/manufacturer for repairs or replacement.
2. Check if all the components listed below are present:
- tap water container with spring valve cap;
- distilled water container with cap;
- carbon filter;
- base unit;
- water tray;
- main unit;
- filter;
- metal clip.
3. Place the water tray on the base unit, install the filter over the heating element and
finally fit the main unit on the base unit;
INSTALLING THE FILTER:
A. Remove the filter from the plastic tray and immerse it in water;
B. Put it over the heating element (Fig.8) and use the metal clip provided to hold it in
place (Fig.9);
Note: The function of the filter is to reduce scales (mineral deposits) build up on the heating element
during the distillation process to ensure maximum heating efficiency and performance of the distiller.
The majority of the mineral deposits will adhere to the filter which can be washed and reused. The filter
must be replaced every other 3 months or sooner depending on the water quality;
4. Place the distilled water container on the base unit with the top opening to the back, on
the left. 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
that one of the following situations is happening:
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HOW TO USE THE CRISTÓFOLI DISTILLER
Fig.8 Fig.9
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A. The tap water container is not properly fitted on the base unit, adjust it;
B. The boiling tray is not completely filled with water. Switch it to “OFF”, wait for the red
LED to go out and switch back to the“ON-Reset” position;
6. Check whether the cooler at the top of the distiller main unit is on;
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”. When the tap water container empties out, the distiller will shut off
automatically and the red LED will light.
7. After the distiller shuts off, press “OFF” on the “ON/OFF Switch” and unplug it from the
outlet.
Warning! Make sure the distiller is cool before touching or handling it. Wait at least 30
minutes for cooling after the equipment shuts off.
When indicated for human drinking, consider that distilled water loses minerals during
the distillation process.
Carry out the first two cycles without the carbon filter and discard the water or use it in
steam sterilization autoclaves, air humidifiers, watering plants, etc.
Note: When the distiller is used for the first time, there can be some remaining harmless
matter from manufacturing, packing or shipping that could alter the taste of the water.
Before proceeding with the third cycle, clean the distilled water container, the tap
water container and the boiling tray with water and neutral soap, rinse them well. Get the
carbon filter from the plastic bag and soak it in water for 30 seconds to rinse away any
loose small particles of carbon and put it on the distilled water container opening, as if it
were a cap and start the third distillation cycle.
When the cycle is complete, remove the carbon filter until the next you need it.
Note: The carbon filter will only be necessary if the water is used for drinking;
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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. The storage cabinets must be easy to
clean, located in a dry room with fresh air, free from odors and away from disinfectants
and/or sterilants.
DISTILLED WATER SHELF LIFE
According to the studies performed, the distilled water shelf life for human
consumption and/or use in steam sterilization autoclaves is 15 days from the date it was
distilled.
REQUIREMENTS TO BE OBSERVED FOR THE DISTILLATION PROCESS
Insufficient operation time;
Incorrect handling of the distiller;
Lack of preventive maintenance;
Power outage;
Defective Distiller.
POSSIBLE FAILURES
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PREVENTIVE MAINTENANCE
Some preventive procedures are necessary for the best functioning and durability
of your Cristófoli Distiller:
Use only regular tap water (potable water provided by the urban water system) or
filtered water;
Keep the distiller clean. The water tray must be cleaned after each distillation
cycle, it is removable and can be immersed in water, washed manually or put into
the dishwasher. Never get the main unit wet or put it in a dishwasher;
The cleaning of the external plastic surfaces must be done daily. Use a cloth
dampened with biodegradable neutral detergent, next, clean them with another
cloth dampened with alcohol 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
build-up on these areas which may cause the distiller to stop working or work
deficiently in case they are not cleaned periodically, the residues will adhere
mostly to the filter, which can be washed and reused, the filter must be replaced
every other 3 months or before that depending on the water quality.
To remove the scales, follow the cleaning instruction below periodically:
- Fill the boiling tray with white vinegar or lemon vinegar, let it rest for at least 3
hours. The cleaning solution will soften the scale deposits. After that, remove the
boiling tray from the base unit and wash it. Fill it again with regular tap water to
rinse the lower part of the main unit. Finally, clean it with a soft damp cloth or
sponge.
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TROUBLESHOOTING
WARNING! For any parts replacement, contact your local dealer. It is strongly not
recommended the replacement of any parts by non-qualified people. We listed below
some possible problems and solutions you can try on your own.
The distiller is not connected to the electric
outlet; Plug the distiller into the electric outlet;
No power; Check if there is a power outage in your
building;
SOLUTIONS
POSSIBLE CAUSES
THE DISTILLER DOES NOT TURN ON
The heating element has burned out; In both cases, contact your local dealer or
Cr istóf ol i dir ec tly t hr oug h th e e-
mail:[email protected]. See “How to
Proceed When Service Is Needed ” (Page
22);
The thermal fuse has burned out;
SOLUTIONS
POSSIBLE CAUSES
THE DISTILLER TURNS ON, BUT IT DOES NOT HEAT UP
Defective power cable; Contact your local dealer or Cristófoli
d i r e c t l y t h r o u g h t h e e m a i l :
[e-mail]. See “How to
Proceed When Service Is Needed ” (Page
22);
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If the problem persists after the verification of all the items listed, contact your local dealer
or a Cristófoli’s Authorized Representative.

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All Cristófoli Distillers are tested on a batch sample basis, according to the parameters
of the table below.
QUALITY CONTROL
6 to 8 hours for 3,8 liters
Cold distiller
3 to 5 minutes
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.
HOW TO IDENTIFY YOUR DISTILLER
Fig.10
Heating Time Distillation Time
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Cristófoli Distiller
127V~ - 0,55 kW - 4,3 A
220V~ - 0,45 kW - 2,2 A
3,8 l
EXEMPT - RDC nº 260/02
50/60 Hz
CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA
ROD BR 158 Nº 127 - CAMPO MOURÃO - PR - BRASIL
CEP 87309-650 - TEL.: [phone]
CNPJ 01.177.248/0001-95 - INSCR. EST. 90.104.860-65
Made in China
Eder William C. Camacho - CREA/PR – 87826/D
IMPORTED BY:
POWER
CAPACITY
MODEL
PRODUCT: WATER DISTILLER.
RESPONSIBLE TECHNICIAN
FREQUENCY
USE INSTRUCTIONS, PRECAUTIONS, CONSERVATION AND STORAGE: SEE INSTRUCTION MANUAL.
ANVISA REGISTER
MODEL
Table 1
Note: The label presented above is just a sample model for your reference.

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TECHNICAL DATA
CERTIFICATIONS.............................................................
TAP WATER CONTAINER CAPACITY...................................
DISTILLED WATER CONTAINER CAPACITY..........................
GROSS WEIGHT (PACKED)..............................................
NET WEIGHT...................................................................
CYCLE TOTAL TIME (full container)..................................
EQUIPMENT DIMENSIONS (W x H x D)..............................
VOLTAGE.......................................................................
FREQUENCY...................................................................
POWER & ENERGY CONSUMPTION.................................
.....................................................................................
PROPER WORKING TEMPERATURE...................................
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
standard similar to GMP-FDA/US) and ISO 14001:2004 -
Environmental Management standards.
4 liters
3,8 liters
4 kg
3,4 kg
6 to 8 hours (for 3,8 liters of distilled water)
27 cm x 33 cm x 27,6 cm
127 or 220V ~ single-phase
50/60 Hz
550 Watts (model 127V) - 0,55 kW/hour
450 Watts (model 220V) - 0,45 kW/hour
15 ºC to 40 ºC
TECHNICAL DATA CHART CRISTÓFOLI DISTILLER
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Table 2