Cristofoli Ultrasonic cleaner User manual

Cristófoli Ultrasonic Cleaner
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.
CRISTÓFOLI’S MISSION
CRISTÓFOLI QUALITY AND ENVIRONMENTAL POLICY
*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).
Develop innovative solutions to protect life and promote health.
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.

Manual Cuba de Ultrassom Cristófoli Ing. Rev.1-2015
CONTENTS
Legend of Symbols ......................................................................................................................................
Intended Use ...............................................................................................................................................
Operation Principle ......................................................................................................................................
Contents of the Box .....................................................................................................................................
Recommendations and Warnings ...............................................................................................................
Installation Instructions ..................................................................................................................................
Components Identification ..........................................................................................................................
Safety Devices .............................................................................................................................................
Degassing / Using the Beaker .......................................................................................................................
Heating ........................................................................................................................................................
How to Use the Cristófoli Ultrasonic Cleaner .................................................................................................
T ............................................................................................................................................echnical Data
How to Identify your Ultrasonic Cleaner ........................................................................................................
Preventive Maintenance ..............................................................................................................................
Troubleshooting ............................................................................................................................................
Quality Control .............................................................................................................................................
Authorized Technical Assistance ..................................................................................................................
Customer Service Department - CSD ..........................................................................................................
Guidance for Final Disposal of the Equipment ............................................................................................
Warranty Terms .............................................................................................................................................
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CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL

LEGEND OF SYMBOLS
~
This side up
Maximum
pile
Caution! Consult
accompanying
documents
Manufacturer
Alternate Current
Protection Grounding
Terminal
Fuse
Date of
manufacture
Good Manufacturing
Practices
5
P
BF
LOT
SN
Fragile - Handle
with care
Dangerous Electrical
Tension
Serial Number
Batch code
Keep away from
sunlight
Recyclable
Keep dry
ISO 13485
ISO 14001
ISO 9001
13485
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Class II
Equipment
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CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL

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This equipment was developed to clean dentistry, veterinary and laboratory instruments/articles as well as any other
material which is suitable for ultrasonic cleaning (cavitation).
INTENDED USE
OPERATION PRINCIPLE
CONTENTS OF THE BOX
Items included in the product box:
- 1 Cristófoli Ultrasonic Cleaner; 1 basket;-
- 1 power cable; - 1 instruction manual.
What is cavitation?
Cavitation is the formation and collapse of millions of tiny little bubbles or cavities inside a liquid produced by the
alternation of high and low pressure waves that are generated by the ultrasonic cleaner The bubbles appear in the .
water/solution and the effect of millions of implosions per second help the enzymatic detergent to break the molecules
of dirt and contaminants, resulting in an efficient cleaning.
RECOMMENDATIONS AND WARNINGS
MANUFACTURER
Shenzhen Codyson Electrical Co. Ltd.
2/F,B & 3/F,East A, Minlida Industrial Building, The 4th Block,
Honghualing Industrial Zone, Xili, Nanshan District,
Shenzhen - China
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]
Responsible Technician
Eder William Costa Camacho
CREA/PR – 87826/D
Read all the instructions in this manual before using your ultrasonic cleaner. Incorrect use may result in deficient cleaning,
damage to the equipment and/or accidents.
The equipment must be handled by qualified and well-informed personnel, regarding its features and functioning.
For your safety, when performing any kind of maintenance, remember to unplug the equipment and use PPE (Personal
Protective Equipment).
Never turn the equipment on without water in the vat, that will cause immediate burn out of the equipment and loss of
warranty.
Never put the instruments/articles or beaker directly into the stainless steel vat for cleaning without the plastic basket.
Never put paper, plastics, towels or any other kind of fabric under the cleaner, this may obstruct the side vents located on
the lower part of the equipment causing overheating and damage to the equipment.
Do not allow patients or especially children to get close to the equipment.
CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
Before initiating the cleaning process, make sure the material to be cleaned may be submitted to ultrasonic
cleaning (cavitation).
Never put your hand or any other part of your body inside the cleaner when it is in use, this procedure may be harmful to
your health.
5
INSTALLATION INSTRUCTIONS
1
2
.The storage must be done in a place protected from the weather action (indoors) in normal temperature conditions
Install the at ultrasonic cleaner in an exclusive sterilization room, ventilated and clean, on a flat, leveled and firm surface,
a proper height for the operator to handle it Leave enough room next to the equipment for handling the instruments/articles..
Table 1
3
The voltage of the ultrasonic cleaner is 127V or 220V, as informed on the identification label located on the bottom
of the equipment. (Fig. 1, pág. 6). Make sure the wiring where the equipment will be installed is in voltage
accordance with these values.
For the installation, use a three pin outlet with grounding pin (2P + T, 10A).
Never use extensions, adapters or voltage transformers.
ATTENTION Grounding is very important for the safety of the operator and the warranty of your equipment! . Install the
ultrasonic cleaner where it can be easily unplugged.
Electrical
See “Authorized Technical Assistance” (Page 13). In case the user chooses an unauthorized electrician or technician to
install the equipment, Cristófoli Biossegurança will not be responsible for any services performed in disagreement with the
instructions described in the product manual.
The electrical installation must follow the data from the table below.
MODEL AMPERAGE WIRING GAUGE (DIAMETER)
Cristófoli Ultrasonic
Cleaner (127 V)
1,5 A
Cristófoli Ultrasonic
Cleaner (220 V)
The wiring from the breaker to the electrical outlet
used to connect the equipment
must have a diameter of at least 2.5 mm.
0,8 A

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
COMPONENTS IDENTIFICATION
Transparent Lid
Stainless Steel Vat
Panel & Control keys
Housing
Air Entrance
Air exhaust
Identification Label
(at the bottom)
Power cable
connector
Front View
Fig.1
Off key
On key
Mode Key
(Adjustment of operation times)
Green LED - indicates that the
equipment is plugged in or in operation
Right red LED - indicates that
the overheating protection is on
Left red LED - indicates
the heating function is on
Heating key
Fig.3 LIG DES MD AQ
Fig.2
Power cable
Fig.4
Basket
(it can also be used in the Cristófoli Plastic Vat
for soaking the instruments)
Beaker
(glass accessory, item sold separately)
Fig.5
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CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
7
DEGASSING / USING THE BEAKER
The water degassing has the purpose of removing the gases dissolved in the
water that impair the cavitation process and must be repeated every time the
water/solution is changed. The procedure consists in leaving the equipment on
for 8 minutes (480s cycle) without any instruments /articles in the vat.
When using the beaker (accessory that must be purchased separately used
to clean very small items (burs, files, etc.) that would certainly go through the
basket orifices falling on the bottom of the vat, remember that the water inside
the beaker must also be degassed Use always a heat resistant glass beaker .
specific for this purpose. Put the water in the stainless steel vat, the basket, the
beaker on top of the basket and water inside the beaker, seal it with some PVC
film (the same used for food wrapping) and proceed the degassing.
Always use the lid when the equipment is operating with the basket, when
using the beaker, remove it, unless the beaker being used has a compatible
size for the basket depth and allow the use of the lid.
The Cristófoli Ultrasonic Cleaner may also be used to clean dental prosthesis
like dentures, bridges or orthodontic devices like braces, etc., as shown by the
drawing (Fig. 6). Fig.6
Fig.7
FUSE - Internal safety device built into the electronic board which . See cuts the power from the equipment
“Troubleshooting” (Page 12).
OVERHEATING PROTECTION SENSOR It protects the cleaner against overheating. If the lig (On) key is pressed, the -
display shows the remaining time and there’s no cavitation (production of ultrasonic waves), that means that the
equipment needs to cool down for about 15 minutes. After that, press lig again and the equipment will resume
operation.
1
SAFETY DEVICES
2
For a deeper cleaning, with the presence of fat, optionally,
the water heating function can be used. Just press the AQ key to
start the water heating (Fig. 7) that will take approximately 40
minutes to achieve the ideal temperature for cleaning, which
is 65 ºC.
Once the right temperature is reached, heating will turn off
automatically The red LED on the left side of the display will be .
on when the heating is in use If it’s needed to reduce the .
heating time, water already warm may be used by the
operator. Do not use water too hot (above 65ºC), this will hinder
the cleaning of the instruments/articles.
HEATING
Red
LED
AQ
DESLIG MD

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
HOW TO USE THE CRISTÓFOLI ULTRASONIC CLEANER
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4
3
5
Pour preferably filtered water up to the maximum level of 2,1 liters indicated on the vat MAX (Fig. 8).
Insert the power cable in the cleaner connector and the other end to the wall outlet The green LED indicates that (Fig. 9).
the equipment is plugged in The display will show the standard cycle of 180s (3 minutes). .
Proceed the water degassing according to the instructions on the topic ” (Page 7).“Desgassing / Using the Beaker
LIG DES MD AQ
Green
LED
LIG DES MD AQ
j
k
Add the right amount of enzymatic detergent in the vat or beaker, diluting it according to the recommendations
specified by its manufacturer. We suggest, for your convenience that you use a small medicine measuring cup or
syringe without the needle to measure the volume of detergent, make sure to reserve this syringe for this purpose only in
case the detergent doesn’t have its own measurer (Fig. 11). Do not use anti-crust solutions/productos, they have a highly
acid concentration, that may damage the vat, its sealing and the instruments.
Put the instruments/articles in the basket or beaker, see the topic “Degassing / Using the Beaker” (Page 7). Do not put
instruments/articles in the basket at the same time you are using the beaker. The instruments must be totally immersed
but not overlapped (Fig. 12).
For a better visualization, the drawings below do not show the lid. Remember to always use the lid when the equipment is
in operation.
Fig.8
Fig.11
Fig.9 Fig.10
Fig.12
8

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
DES DES DES DES DES
MD MD MD MD MD
AQ AQ AQ AQ AQ
LIG LIG LIG LIG LIG
3 min. 4 min. 30 s. 6 min. 30s. 8 min. 1 min. 30 s.
Fig.13
Select the time desired on the panel using the MD key. The time selection begins with the standard cycle of 180s (3 min.).
Each touch on the MD key, the display will show one of the 5 preset cleaning times (Fig.13).
Press the lig key to start cleaning (Fig. 14), at this moment the operator will hear the typical sound of the cavitation
process. key (Fig. 15) To pause the cycle press the des to resume cleaning, press lig again.
6
7
Fig.14 Fig.15
DES
LIG MD AQ
LIG DES MD AQ
At the end of the cycle the display will show 000 and the cavitation process will stop automatically. Unplug the
equipment and open the lid. .(Fig. 16)
Remove the beaker or the basket with the instruments/articles from the vat as soon as the cleaning finishes and perform
a visual inspection, if there’s still any residue left, remove it with a proper brush.
8
9
Fig.16
j
kl
9

Finally, pour the contaminated solution into an appropriate sink, used exclusively for this
purpose proceeding like this: carefully tip the equipment over one of its back corners to
avoid getting the control panel wet (Fig. 17) and dispose the solution into the sink. For a
new cycle, wait 15 minutes and then follow the use instructions again.
10
Fig.17
TECHNICAL DATA
Table 2
Total Capacity ...............................................................................
Useful Capacity .............................................................................
Net weight .....................................................................................
Gross weight ..................................................................................
External dimensions (W x H x D) ....................................................
Internal dimensions (W x L x D) .....................................................
Voltage .........................................................................................
Frequency .....................................................................................
Power ............................................................................................
......................................................................................................
Ultrasonic frequency ......................................................................
Timer .............................................................................................
Power consumption .......................................................................
......................................................................................................
Proper working ambient temperature .............................................
Certifications .................................................................................
2,5 liters
2,1 liters
2,5 kg. (with components)
3 kg. (in the box)
28,5 x 18,5 x 22,5 cm
28,8 x 14,8 x 8 cm
127 or 220 V
50/60 Hz
160 Watts (127 V model)
170 Watts (220 V model)
42 kHz
Digital: 5 preset time cycles (180s - 280s - 380s - 480s - 90s)
16 Watts/hour (127 V model)
17 Watts/hour (220 V model)
15 to 40 ºC
This equipment is imported by Cristófoli Biossegurança, 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.
TECHNICAL DATA CRISTÓFOLI ULTRASONIC CLEANER
10
CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL

The identification label is affixed on the bottom of the equipment (Fig. 1, page 6).
ATTENTION - Removing the identification label and/or any other stickers from the product will cause automatic loss of
warranty.
HOW TO IDENTIFY YOUR ULTRASONIC CLEANER
Some procedures are necessary for the best functioning and durability of your equipment. The preventive
manintenance corresponds to the fulfilment of all procedures listed below.
Make sure the equipment is unplugged before performing any kind of maintenance.
PREVENTIVE MAINTENANCE
PERIODICITY
MAINTENANCE
DAILY
External cleaning:
Unplug the equipment. Clean it with a soft cloth moistened in water and neutral biodegradable
detergent, next, use another soft cloth moistened with alcohol 70% or peracetic acid at 1%.
Clean the lid the same way. Wipe it with smooth movements in only one way.
Vat cleaning:
Clean the stainless steel vat and change the cleaning solution after each cycle to maintain the
cleaning efficiency. The contaminated solution must be disposed according to the instructions
of the topic “How to Use the Cristófoli Ultrasonic Cleaner”, instruction 10 (Page 10).
After disposing the water/solution, remove the excess of residues that may have accumulated
at the bottom of the vat with a soft sponge, cloth or even paper towels, then clean it with a soft
sponge with water and neutral detergent, rinse it with running water (be careful not to get the
control panel wet, avoiding this way that some water get into the equipment through any of its
many orifices), dry the vat with a soft cloth or paper towel and finish by disinfecting it with alcohol
70% three times according to the technique recommended for its use (BRASIL 1994).
ANNUAL
We recommend performing a general preventive maintenance of the equipment with a
Cristófoli authorized technician. See “Authorized Technical Assistance” (Page 13).
Table 3
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CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL

12
CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
For any replacement of parts, contact your local retailer or an authorized Cristófoli representative. It’s strongly not
recommended the replacement of any parts by non-qualified people.
We have listed below the most frequent problems and possible solutions the operator can try in his/her own office.
TROUBLESHOOTING
If the problem persists after the verification of all the items listed, contact your local retailer
or an authorized Cristófoli representative.
•·The equipment may be 220V and be connected to
a 127V power outlet ----------------------------------------------
•·Damaged circuit board --------------------------------------
•·See that the necessary arrangements for the electrical wiring
are made as shown on item “Installation Instructions” (Page 5).
• See “Authorized Technical Assistance” (Page 13).
•·Plug the power cable on both ends, the power connector of the
cleaner and the wall outlet (Fig. 9, page 8).
• See “Authorized Technical Assistance” (Page 13).
•·Check if there’s a power outage in your building.
•·The equipment is not plugged in ----------------------------
•· --------------------------------------------------Burned out fuse
•·No power --------------------------------------------------
THE ULTRASONIC CLEANER DOES NOT TURN ON
LOW CAVITATION OR NO CAVITATION AT ALL
• See “Authorized Technical Assistance” (Page 13).
•· ----------------------The heating element has burned out
POSSIBLE CAUSES SOLUTIONS
POSSIBLE CAUSES SOLUTIONS
POSSIBLE CAUSES SOLUTIONS
THE ULTRASONIC CLEANER TURNS ON BUT THE HEATING DOES NOT WORK
•·The transducer burned out because of the lack of
water in the vat or incorrect voltage installation -----------
• See “Authorized Technical Assistance” (Page 13).

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
13
CUSTOMER SERVICE DEPARTMENT - CSD
In case you have doubts, complaints or suggestions, contact Cristófoli through the Customer Service Department -
CSD by the e-mail: [email protected].
AUTHORIZED TECHNICAL ASSISTANCE
If there’s any problem with your equipment, first, take a look at the topic “Troubleshooting” (Page 12), in case the problem
persists, get in touch with your local retailer or an authorized Cristófoli representative to schedule an evaluation or repair of
your equipment.
Before making contact, please have in hands the model of your equipment, voltage, serial number and the date of
manufacture found on the identification label located on the bottom of the equipment (Fig. 1, page 6) and a description of
the problem.
The environment is something that belongs to everyone, therefore, it is up to each one of us to make the decisions
that will help in its preservation and reduction of the damages resulting from human activities.
All products have a useful life span, but it is not possible to determine how long, as it varies according to the
intensity and how the equipment is used or handled.
Cristófoli Equipamentos de Biossegurança Ltda., makes clear its concern, already demonstrated by the
implementation of the Environmental Management System, according to standard NBR ISO 14001:2004, strongly
recommends users of their products to seek the best destination when disposing your equipment or its components,
taking into account the materials recycling legislation effective in your country.
We advise you to take your equipment to specialized recycling companies that, due to the continuous and fast
paced development of new recycling technologies and materials reuse, provide the best way of disposing the
equipment. Cristófoli contributes this way to reduce the consumption of non-renewable raw materials.
On behalf of all users, we thank you for your comprehension and cooperation.
GUIDANCE FOR FINAL DISPOSAL OF THE EQUIPMENT
QUALITY CONTROL
The Cristófoli Ultrasonic Cleaners are tested on a batch basis according to the internal parameters of tests and
manufacturing approved by the Cristófoli Quality Control Department.

CRISTÓFOLI
ULTRASONIC CLEANER
INSTRUCTION MANUAL
14
WARRANTY TERMS
CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA., warranties the Cristófoli Ultrasonic Cleaners for 01 (one) year
against any manufacturing defect from the date of the purchase receipt (provided it contains the serial and lot numbers of
the equipment), of which 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 technician for installation, repair or
maintenance before or after the warranty period will be responsibility of the buyer/owner as well as the freight charges for
shipping the equipment to the authorized technical assistance office for repairs or if necessary, to the factory itself.
The warranty will be voided in cases of:
• Problems arising from natural causes (such as floods, landslide, building collapse, lightning, etc.);
• Damage caused by accidents, such as: dents, drops, short circuits, fire, etc.;
• Sinister (theft or robbery);
• Improper use / installation of the equipment and/or plugging it into an incorrect voltage outlet;
• Problems due to failure of the power supply and/or building wiring;
• Removal and/or tempering of the serial number shown in the identification label of the product;
• Signs of tampering and/or blotted out data on the purchase or service receipt of the equipment;
• Signs of external violation of the product or broken factory seal;
• Lack of preventive maintenance of the equipment or neglect regarding any item presented on the topic “Preventive
Maintenance” of this instruction manual;
• Use of non-original parts or parts not acquired at the Cristófoli Authorized Service Network;
• Repairs performed by technicians who are not part of the Cristófoli Authorized Service Network;
• Noncompliance with any measure or caution recommended in the instruction manual of the product.
The internal fuse, the basket and the power cable are not covered by the warranty. The warranty will also not cover
damages caused to instruments / articles with low resistance to ultrasound cleaning or their natural wearing.
ATTENTION! In order to validate the contractual warranty of the product it is necessary to send a copy of the purchase
receipt to the following e-mail address: [email protected].