Cristofoli Autoclave Baby User manual

CRISTÓFOLI’S MISSION
CRISTÓFOLI 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.
Develop innovative solutions to protect life and promote health.
Autoclave Baby
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
D
E
S
G
A
E
M
S
E
T
T
Ã
S
O
I
S
*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).

“Cristófoli. Valuing Life!”
2
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, in the use and maintenance of your Cristófoli Autoclave.
We would like to thank all our customers, partners and employees 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 a valuable
assistance in the coordination of Cristófoli’s Biosafety Project; complementary products research; training of our
employees, representatives and technicians; and as a lecturer of Biosafety Courses for professionals, academics and
assistants.
For any commentaries or suggestions about our products, please get in touch with our CSD - Customer Service
Department, through the address below.
Docs/Layouts Informativos/Manual Baby/Baby Ing. Rev.1-2015
Cristófoli Equipamentos de Biossegurança Ltda.
Rodovia BR-158, nº127, Campo Mourão, Paraná - Brasil.
CEP 87309-650
E-mail: [e-mail]
CSD - CUSTOMER SERVICE DEPARTMENT
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L

Legend of Symbols ......................................................................................................................................
Introduction .................................................................................................................................................
Important Safety Information .......................................................................................................................
Installation Instructions ..................................................................................................................................
Autoclave Components Identification .........................................................................................................
Safety Devices .............................................................................................................................................
Cycles and Messages .................................................................................................................................
Safety Notes .................................................................................................................................................
How to Use the Autoclave Baby ...................................................................................................................
Adverse Situations ........................................................................................................................................
Altitude Calibration ......................................................................................................................................
Technical Data ............................................................................................................................................
Time x Pressure Graphs ................................................................................................................................
Quality Control .............................................................................................................................................
How to Identify your Autoclave ....................................................................................................................
Troubleshooting ............................................................................................................................................
Preventive Maintenance ..............................................................................................................................
Preventive Maintenance Table ....................................................................................................................
How to Proceed When Service is Needed ...................................................................................................
Guidance for Final Disposal of the Equipment ............................................................................................
Warranty Terms .............................................................................................................................................
INDEX
PLEASE, READ ALL THE INSTRUCTIONS IN THIS MANUAL BEFORE USING YOUR
AUTOCLAVE, INCORRECT USE MAY RESULT IN STERILIZATION FAILURE AND/OR ACCIDENTS!
04
05
06
07
09
11
12
12
13
16
16
17
18
18
18
19
21
22
23
23
24
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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L

4
LEGEND OF SYMBOLS
Tinta
com propriedade
antimicrobiana.
~
This side up
Maximum
pile
Caution! Consult
accompanying
documents
Manufacturer
Alternate Current
Grounding
Protection Terminal
Fusible
Autoclavable
Date of
manufacture
*Boas Práticas
de Fabricação
4
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
D
E
S
G
A
E
M
S
E
T
T
Ã
S
O
I
S
Class ll
Equipment
Antimicrobial
Painting
135 ºC
*BPF: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US)
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L

5
This equipment was developed to assist you in the procedure of steam sterilization of articles/instruments by using steam
under pressure. We have intensively dedicated ourselves in order to guarantee your total safety. We hope in this way to
obtain your full satisfaction.
The purpose of this manual is to familiarize you with the features and proper operation of your autoclave so you know
how to take good care of it, obtain the best results in sterilization and drying, as well as increase the equipment’s life span.
For those who have used only the dry heat sterilizer (Pasteur’s oven) for sterilization, we recommend extra attention to this
manual. Autoclave sterilization, although quicker and more efficient, requires totally different procedures and handling,
while still keeping a simple operation.
It is important to know some aspects that can jeopardize this warranty as a result of negligence, improper use,
unauthorized repairs, etc.
24.The Warranty Terms can be found on Page
Box contents: 1 autoclave - 1 power cable - 1 envelope support - 1 measuring cup - 1 samples kit (hose and clamp) and
1 instruction manual.
INTRODUCTION
MANUFACTURER
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
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
IMPORTANT SAFETY INFORMATION
Before using your autoclave Baby, It is necessary to observe some safety measures. Autoclaves are pieces of
equipment which work at high temperature and pressure, therefore they must be handled by qualified and well-
informed personnel, regarding their features and functioning. It is essential for such qualification that the operators read
all the instructions carefully before using the autoclave to make sure to understand them correctly The intended use of .
this equipment is to perform sterilization on dental, medical and hospital instruments/articles, as well as articles and
instruments used in the aesthetics, beauty, manicure, podiatry, tattoo and body art areas resistant to the temperature of
121ºC and/o .r 135ºC, steam and pressure
WARNINGS:
Before sterilizing any articles, make sure you first check with their manufacturer if they are autoclavable (resistant to
the temperature of 135ºC and the presence of steam and pressure).
Do not allow patients or especially children to get close to the autoclave.
Install the autoclave in an exclusive sterilization room.
Never warm up or sterilize any kind of food in the autoclave;
Never make any kind of experiment with animals in the autoclave;
Never make any kind of use of this equipment other than the ones described in this manual.
SPECIAL MEASURES AND OBSERVATIONS DURING THE USE OF THE AUTOCLAVE:
Always make sure the door handle is properly locked before switching the autoclave on See “How to Use the .
Autoclave Not following this procedure may cause the door gasket to pop off Baby”, (Item c, page 13). .
When sterilizing instruments that have different autoclaving specifications simultaneously, as instruments that support
2
different levels of pressure (1.2 or 2.1 kgf/cm ) or temperature (121 or 135ºC) the operator must choose the cycle of
lower temperature/pressure offered by autoclave.
When unlocking the handle, the autoclave door should open easily. Never force the door to open the autoclave!
When the door is opened at the end of the cycle to accelerate the cooling process, it is normal that some steam
comes out through the door.
IMPORTANT! Always make sure you unplug the equipment to perform any kind of maintenance (like simply
changing a fuse or performing an everyday cleaning).
We recommend reading this manual until it is fully understood. Keep it at hand and use it as a constant reference
source.
ATTENTION! TO OPEN THE AUTOCLAVE
1 - Press the door forward; 2 - Lift the handle; 3 - Slide it to the left.

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
INSTALLATION INSTRUCTIONS
PHYSICAL INSTALLATION
Install the autoclave on a flat, leveled and firm surface at a proper height for the operator to handle it
(approximately 80 cm / 2.6 feet from the ground). Leave enough room close to the autoclave for the proper handling
of the materials to be sterilized. Install the autoclave in a ventilated and clean place, apart from the room where the
patients are treated. The ideal place for the installation of the autoclave should be a separate sterilization room.
Important! Install your autoclave where it can be easily unplugged.
ELECTRICAL INSTALLATION
ou are going to install it. To do that, simply Check if the voltage of the autoclave is the same of the place where y
look at the identification label in the back of the autoclave. See “How to Identify your Autoclave” (Fig. 17, page 18).
For the installation use a grounded outlet (2P + T, 10A) connecting phase/neutral or phase/phase on the side pins
and grounding on the central pin (Fig. 2, page 8). Never connect the grounding on neutral.
ATTENTION! As in any other electrical device, grounding is very important for the safety of the operator and the warranty
of your equipment. Therefore, never remove or cut the plug’s central (grounding) pin off. Non-compliance with this
requirement may damage your autoclave. Cristófoli is not responsible for damages caused by inadequate
installations and/or voltage.
Never use extensions, voltage transformers or any kind of adapters (Fig. 3, page 8).
For the proper functioning of your autoclave, the electrical voltage must be stable, in other words, without
oscillations Consult a professional electrician to check the electrical wiring in your building and make sure they are .
according to the specifications required It is mandatory the use of an exclusive circuit breaker for the outlet .
where you intend to install your autoclave. If after following all the specifications, the electrical current is still
oscillating, contact your local electricity company for repairs.
The equipment must be always carried carefully to prevent it from falling or causing an accident. The storage/installation
must be done in a place protected from the weather action (indoors) in normal temperature conditions on a counter that
can bear the weight of the equipment.
Cristófoli Autoclave Baby can be easily installed. Check if the wiring and voltage of your building are in accordance with
the specifications below by consulting a professional electrician or Cristófoli Authorized Technical Assistance. See “Warranty
Terms ” (Page 24) and “How to Proceed When Service is Needed” (Page 23). In case the end user chooses an unauthorized
technician to install the autoclave, such technician should follow all the guidelines described in the instruction manual for
the physical, electrical and hydraulic installation of the equipment. Cristófoli is not responsible for any services performed in
disagreement with the instruction manual that accompanies the product.
The electrical installation must follow the data from the table below.
Note: In areas where voltage is 220V:
PP (Phase-Phase) use a “bipolar” breaker
PN (Phase-Neutral) use a “unipolar” breaker connected to Phase.
1
2
4
3
Table 1
MODEL NOMINAL
CURRENT WIRING GAUGE
CIRCUIT BREAKER VOLTAGE
Baby - 127 V
6,3 A
3,7 A
127 V AC » 114 V - 140 V
220 V AC » 198 V - 242 V
For distance 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) use 4 mm,
and from 15 to 50 m (46 to 164 ft) 6 mm.
1 Breaker 10 A.
Baby - 220 V
1 Breaker 10 A.

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
HYDRAULIC INSTALLATION
.For the correct connection of the components, it is essential to read the instruction manual
sistant rubber hose (5/16”, 300 psi as sample provided) and connect it to the external steam exit Purchase a heat re
(Fig. 1) located in the back part of the autoclave, put the clamp on (also provided, Fig. 12, page 10) and fasten it with
a screwdriver. The other end must be connected to the plumbing system into a special pipe that can tolerate at least
100ºC (212ºF) or to an open container positioned about 40 cm below the level of the autoclave with water inside for
steam discharge (Fig. 1A), in this case, the hose must be above the water level with a “V” cut on its end and must be
inspected yearly for obstructions and general condition.
NOTE: To replace the hose of the external steam exit, make sure the autoclave is cold and unplugged from the
electrical outlet, loosen the clamp and replace the old hose by the new one, put the clamp back on and fasten it.
WARNING! Never use a plastic hose, the heat will melt it causing an obstruction of the external steam exit.
MODELO
LOT
SN
POTÊNCIA
PRODUTO: AUTOCLAVE CRISTÓFOLI PARA ESTERILIZAÇÃO A VAPOR.
MODELO
AUTOCLAVE BABY
FREQUÊNCIA - 50/60 Hz
REGISTRO ANVISA - 10363350005
RESPONSÁVEL TÉCNICO
Márcio Cyrilo Ribeiro - CREA/SP – 5062245952/D
CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA
ROD BR 158 Nº 127 - CAMPO MOURÃO - PR
BRASIL - CEP 87309-650 - FONE: 55 44 3518-3432
CNPJ 01.177.248/0001-95 - INSCR. EST. 90.104.860-65
INDÚSTRIA BRASILEIRA
INSTRUÇÕES DE USO, PRECAUÇÕES, CONSERVAÇÃO E ARMAZENAMENTO:
CONSULTE O MANUAL DE INSTRUÇÕES
PRESSÃO MÁXIMA -
CAPACIDADE -
CONFORMIDADE - NORMA NBR 11817
Fig. 2
GROUNDING
(DO NOT CONNECT GROUNDING ON NEUTRAL)
NEUTRAL - PIN 1
PHASE - PIN 2
Fig. 1A
Fig. 3
WATER
“V” CUT
DO NOT USE THE LID
KEEP THE HOSE ABOVE
THE WATER LEVEL
5 liters
(1.3 gallons)
Table 2
X
Fig. 1
EXTERNAL STEAM
EXIT
POWER CONNECTOR
FUSE HOLDER
IDENTIFICATION
LABEL
POWER CABLE
BUZZER (under the base)
NEVER CUT THE
CENTRAL PIN OFF
Bipolar plug e wall outlet with grounding
(three pins or 2P+T) 10 A
A T T E N T I O N
GROUNDING IS ESSENTIAL
127 V
CONNECTION
220 V
220 V
PHASE (127 V)
NEUTRAL
NEUTRAL PHASE 220 V)
PHASE (127 V)PHASE (127 V)
PIN 1 PIN 2

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
AUTOCLAVE COMPONENTS IDENTIFICATION
3
2
1PANEL - It is in the front part of the autoclave, made with ABS injected plastic, it is where the keyboard and display
are located (Fig. 4).
LID - Located right behind the panel, it’s made of stainless steel and it is responsible for closing the autoclave
chamber. The lid must be replaced each 10 years (Fig. 7).
KEYBOARD - Located in the panel, it is where the control keys and display of the autoclave are (Figs. 4 and 5).
DISPLAY - It is where all the functions/messages of the autoclave are shown, it has two lines with 16 characters each.
It’s located in the center of the keyboard (Fig. 5).
HANDLE - Located in the front part of the autoclave (Fig. 4). It’s used to open, close and lock the autoclave door
(panel/lid set). To check the door correct locking position see Figs.14 and 15 (Page 13).
DOOR GASKET Attached to the door, its function is to seal it with the chamber it also works as a - (Figs. 6 and 7),
safety device. See “Safety Devices” (Item 2, page 11). It requires weekly maintenance. See “Preventive
Maintenance” (Page 21).
4
5
6
Fig. 6
Fig. 7
Safety Valve Anti-Vacuum Valve
Door Gasket
Lid
Detail
Detail
Fig. 5
Fig. 4
Panel
Keyboard
Handle
Início
Start
Cancela
Cancel
Modo
Mode
BABY
A u t o c l a v e
0000000 00 00 00000
0000000 00 00 00000
Display
Start Key
Mode Key
Cancel Key
Início
Start
Cancela
Cancel
Modo
Mode
BABY
A u t o c l a v e
0000000000000000
0000000000000000
Keyboard

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
SAFETY VALVE AND ANTI-VACCUM VALVE - The safety valve is one of the devices responsible for relieving the pressure
inside the chamber in case it goes beyond the established limits. The anti-vacuum valve has the same function, it
releases the vacuum inside the chamber when needed (Fig. 7, page 9). See “Safety Devices” (Items 3 and 4, page
11).
INTERNAL STEAM EXITS - There are two orifices inside the chamber (Fig. 8) that work as conduits for the steam from
the chamber to the solenoid valve. They must be inspected daily to be kept free from obstructions.
ATTENTION! When loading the instruments/articles into the autoclave, be careful not to put them against or too close
to the internal steam exits, that will cause interference in the cycle.
EXTERNAL STEAM EXIT Located in the back part of the autoclave it has a diameter of for the - (Fig. 1, page 8), 5/16"
connection of the discharge hose which is then connected to the plumbing system or proper container for this ,
purpose It releases the cold air in the beginning of the cycle and the steam at the end of it. . See “Installation
Instructions” topic “Hydraulic Installation” (Page 8).
SOLENOID VALVE It - Internal component of the equipment responsible for the deareration and depressurization.
opens in the beginning of the heating stage eliminating the cold air from the chamber, then it shuts down to allow
pressure build up for the sterilization and opens again at the end of the cycle for the depressurization of the
chamber.
BASE (metallic structure) - The base of the autoclave is produced in carbon steel with textured electrostatic
painting The paint used (Nobak) has antimicrobial properties (Fig. 8);.
8
7
9
10
11
Fig. 8
Internal Steam Exits
Fig. 9
Fig. 9A
Base
Cover
Sterilization Chamber
Note: When using sterilization
envelopes, arrange them side by side
on the support provided (Fig. 9A).
Fig. 10 Fig. 12
Fig. 11
250 ml
50 ml
200 ml
150 ml
100 ml
Vitale 21
Vitale 12
Baby

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
COVER - It is produced in carbon steel with textured electrostatic painting. The paint used (Nobak) has antimicrobial
properties (Fig. 8, page 10);
ENVELOPE SUPPORT - It is provided 1 stainless steel support to keep the instruments to be sterilized free from any
direct contact with the water and internal surface of the autoclave chamber (Fig. 9, page 10);
MEASURING CUP - It’s used to measure the right amount of distilled water necessary for the sterilization process (Fig.
10, page 10);
POWER CABLE - Used to connect the equipment to the power outlet (Fig. 1, page 8 and Fig. 11, page 10);
CLAMP - Used to fasten the discharge hose to the external steam exit (Fig. 12, page 10);
BUZZER - Internal device located under the base of the autoclave. Its function is to emit the beeps produced by the
autoclave (Fig. 1, page 8);
CHAMBER - Produced in anodized aluminum, the sterilization chamber is where the instruments/articles to be sterilized
are placed (Fig. 8, page 10).
17
18
12
13
14
15
16
:The autoclaves Baby have the following safety devices
TEMPERATURE X PRESSURE DATA CROSSING ELECTRONIC SYSTEM - Internal system of the equipment which will check
the cycle, in case any problem is detected while reading the pressure in the chamber or if it exceeds the safety
limit, the cycle will be cancelled automatically;
2
DOOR GASKET - In case the pressure goes beyond 3 kgf/cm or 294 kPa, the door gasket will detach from the edge
of the door making a loud noise. See “Autoclave Components Identification” (Item 6, page 9);
2
SAFETY VALVE - It opens when the pressure reaches from 2 to 2,5 Kgf/cm or 200 to 250 kPa. See “Autoclave
Components Identification” (Item 7, page 10);
ANTI-VACUUM VALVE - It works the same way of the safety valve by releasing the vacuum build-up inside the
chamber. See “Autoclave Components Identification” (Item 7, page 10);
FUSE - Safety device which purpose is to protect the electrical wiring against peaks of energy. The fuse used is the 20
AGLF Glass - Quick Action. In case the operator wishes to replace the fuse personally, the table below will provide
the necessary information. See “Troubleshooting” (Page 19);
SAFETY DEVICES
Table 3
VOLTAGE
FUSE
127 V (114 V - 140 V)
127 V 8 A (250 V)
220 V 220 V (198 V - 253 V) 5 A (250 V)
AC VOLTAGE LINE
3
2
1
4
5
THERMOSTAT - Internal safety device of the equipment. Its function is to limit the excessive heating of the chamber
during the sterilization cycles or in case a circuit board malfunction occurs;
POWER CONTROL ELECTRONIC SYSTEM - Internal system of the equipment which monitors the temperature and
pressure of the autoclave throughout the operation.
6
7

12
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
Warning! - During the autoclave operation, it is perfectly normal to hear some noises, some low, some loud. The
noises are generated by the valves opening and closing, deaeration and depressurization, they are part of the proper
functioning of the equipment. The door gasket and the safety and anti-vaccum valves are safety mechanisms that
when activated discharge pressure automatically producing a loud noise. This autoclave must be installed in a proper
and exclusive sterilization room. Cristófoli is not responsible for accidents that might occur due to the starts caused by
the noises produced by the autoclave.
The symbol 14 appears in some places on the autoclave. This means those items require special attention and
that the user must observe their references in the Instruction Manual provided with the equipment regarding potential
hazards offered by them and any actions to be taken should an adverse situation occur.
Cristófoli Equipamentos de Biossegurança Ltda. does not take any responsibility for failures and/or accidents
caused by the non-observance of this warning.
SAFETY NOTES
. The display represented below also shows We have listed below the various messages displayed by the autoclave
the initial information (brand, model and software version) when the autoclave is turned on.
CYCLES AND MESSAGES
MESSAGES
WHEN TURNED ON
cristofoli
Baby v 00
CYCLE OPTIONS
>121°C 30 min.
134°C 10 min.
121°C 30 min.
134°C 10 min.>
HEATING UP 00:00
T : 000°C
HEATING UP 00:00
T : 000°C p : 0.00
DRYING 00:00
open the door
for drying
DEPRESSURIZING
p : 0.00
Cycle CONCLUDED wait for cooling
T : 000°C
Cycle Cancelled
p : 0.00
STERILIZ. 00:00
T : 000°C p : 0.00
Cycle Cancelled
Note: The manufacturer reserves the right to update the software version, as well as make changes and/or improvements to this
product at any moment without prior notice.

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
HOW TO USE THE AUTOCLAVE BABY
aOpen the door of the autoclave and use the measuring cup provided to pour distilled water directly into 100 ml of
the chamber before each cycle (Fig. 13) according to the table below.
Fig. 13
Fig. 15
Fig. 14
Table 4
1/2
litro
ml
450
400
350
300
250
200
150
100
50
Início
Start
Cancela
Cancel
Modo
Mode
BABY
A u t o c l a v e
00000 00000 00000 0
00000 00000 00000 0
ATTENTION! Use only distilled water. Non compliance with this
recommendation may cause obstructions of the hydraulic system of
the autoclave (internal pipes and/or valves), stains on the instruments
and loss of warranty.
Amount of distilled water
for each cycle
100 ml
Close the door of the autoclave. To close it correctly, with the door open and the handle all the way to the left,
close the door by pressing it against the chamber, slide the handle to the right, and then press it all the way down
until it’s aligned with the panel To open the autoclave, follow the same procedure reversing this (Figs. 14 and 15).
sequence.
ATTENTION! Non-observance of this recommendation may jeopardize the best functioning of your autoclave, it may
even cause the door gasket to detach from the door. It is very important to have the autoclave properly closed and
locked to avoid accidents and burns.
Load the autoclave with the materials to be sterilized, be careful not to lean them against the chamber walls or
internal steam exits, that will cause interference in the cycle and damages to the articles. Do not overload the
autoclave.
b
c
Before using the autoclave for the first time, it is necessary to perform the altitude calibration procedure.
See “Altitude Calibration” (Page 16).

14
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
eTo select the 134°C cycle, press the MODE key. . Each time Each cycle has a specific operation time/temperature
this key is pressed the arrow will switch between the preset programs in the following order: or
. Regardless of the program selected, the packages must always be wrapped individually with
surgical grade paper for each client/procedure.
Utilize the 134ºC program for kits which have metallic instruments. Example:
- kits for manicure, podiatry (nippers and metal pushers protected by cotton wrapped in surgical grade paper);
- tattoo or body-piercing materials (metallic tips, piercings and/or tweezers wrapped in surgical grade paper).
The 121ºC program is longer and suitable for more sensitive materials. Example:
- plastics or gauze. In case it’s necessary to prepare packages with different contents such as metallic
instruments and plastics, choose the 121ºC program;
Before sterilizing any article, make sure you first check with its manufacturer if it is autoclavable (resistant to the
temperature of 135ºC and the presence of steam and pressure);
Plug the autoclave in and press the START key, at this moment, the display will show the initial information (brand,
model and software version), the autoclave will then beep twice and select the 121 C cycle automatically, the °
display will show:
d
>121°C 30 min.
134°C 10 min.
121°C 30 min.
134°C 10 min.>
>121°C 30 min.
134°C 10 min.
The table below provides information regarding the autoclave programs.
Table 5
2
1- 121 ºC 6 to 35 min. 121 ºC / 118 kPa (1.2 kgf/cm ) 30 min. 15 min.
2
2- 134 ºC 6 to 35 min. 134 ºC / 210 kPa (2.1 kgf/cm ) 10 min. 15 min.
Maximum Drying Temperature: 121 or 134 ºC ( ).depending on the cycle chosen
Sterilization
Temperature and Pressure Sterilization
Time
Mode Drying
Time
Heating
Time
Obs: Heating time values are expressed considering the technical data chart (Table 6, page 17) regarding the autoclave
proper working temperature range.
After choosing one of the programs through the MODE key, press the START key In case this is not the first cycle of .
the day and the temperature of the autoclave is above 50 ºC, the autoclave will beep twice and the display will
show the message and the corresponding temperature.
As soon as the ideal temperature for the new cycle is reached, the autoclave will beep three times and switch
automatically to ;
W the solenoid valve shuts down, the display will show the temperature and pressure rising gradually. hen When the
autoclave reaches the ideal temperature/pressure for the selected program, the autoclave will beep twice and the
f
wait for cooling
T : 000°C
heating up 00:00
T : 000°C

15
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
display will show remaining like that for the preset time according to the program chosen.
At the end of the sterilization, the solenoid valve will open producing a characteristic click sound and the autoclave
will beep three times. The display will show .
During the heating and drying stages, the solenoid valve makes a humming noise, similar to the one produced by
electric motors, it may also open/close automatically during the drying stage.
STERILIZ. 00:00
T : 000°C p : 0.00
DEPRESSURIZING
p : 0.00
iTurn the equipment off after using it. To do that, hold the Cancel key pressed, the autoclave will beep once and
turn off. At the end of the work shift, unplug the equipment.
ATTENTION!
When opening the autoclave for drying, observe the correct
position of the door in the picture. The autoclave Baby
dries with the door ajar, its opening is necessary to allow
steam evaporation and provide an efficient drying process.
Upper view
Fig. 16
When the depressurization is over, the drying stage will follow automatically, the autoclave will beep 7 times and the
display will show the message . During the drying stage the display will show .
At this moment, the operator must open the door of the autoclave and leave it ajar for the drying cycle (Fig.
16).
At the end of the drying stage, the autoclave will beep 5 times and the display will show . Press
the CANCEL key, that will bring the system back to the program selection mode.
ATTENTION! Even after the beeps that indicate the conclusion of the cycle the contents of the chamber will still be ,
very hot Never touch the internal parts of the autoclave directly (chamber, support, materials, etc.) wait . when hot,
for them to be cool enough before handling Remember to use safety gloves for thermal protection. .
g
h
open the door
for drying
drying. 00:00
Cycle Concluded

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CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
Some situations may cause interruption and automatic cancellation of the cycle when:
the ideal pressure/temperature is not reached due to steam/pressure leak, lack of water or overloaded chamber.
In this case, the cancellation will occur within 35 minutes at the most;
there’s a power outage or voltage fluctuations. Note: The depressurization will occur when power returns;
turning the autoclave on, there’s already some pressure in the chamber. When that happens, the autoclave will
beep continuously, the display will show CYCLE cancelled and the autoclave will depressurize;
Confirm the cancellation of the cycle manually by pressing the CANCEL key;
Check the possible causes, take the necessary measures to correct the problem and perform a new cycle
to reprocess the articles according to the instructions on “How to Use the Autoclave Baby” (Page 13). Before
starting a new cycle, the operator must check if there is water left in the chamber, which must be removed
manually through the door with a clean and dry cloth that does not shed. Attention! For your safety,
remember to use PPE (Personal Protective Equipment, like proper latex gloves);
To interrupt/cancel the heating, sterilization or drying stage, just press the CANCEL key. In this case, after the beep
and the indication cycle cancelled on the display, the autoclave will beep continuously until the pressure falls to 0,0
2
kgf/cm and the CANCEL key is pressed again to confirm the cancellation of the cycle (there will be no effect in
case the CANCEL key is pressed while there’s still pressure in the chamber);
In case of activation of one of the safety devices (sudden steam escape), generally caused by obstruction of the
internal steam exit or by an obstruction of the solenoid valve, wait for complete depressurization before opening the
door. The display will show cycle cancelled. We recommend consulting an authorized technician to check the
possible causes of the problem.
ADVERSE SITUATIONS
a
b
1
c
2
3
ALTITUDE CALIBRATION
In order for the autoclave to work properly, it is necessary to perform the altitude calibration procedure. Calibrate the
altitude of the autoclave as shown below, for this procedure the autoclave must be empty.
2
3
1
4
5
6
7
8
Unplug the autoclave;
Open the door of the autoclave, use the measuring cup to add the correct amount of distilled water directly into
the chamber before each cycle (100 ml);
Press and hold the START key and plug the autoclave in;
Release the START key, the display will show the message ;
Close the door;
During the heating stage, the display will show the chamber temperature while the altitude is being measured, the
calibration will finish automatically, the autoclave will beep twice and the display will show , that
means the calibration procedure was successfully performed;
Open the door, unplug the equipment and allow it to cool down;
The autoclave is ready to be used.
Note: In case the autoclave is taken to another workplace where the altitude is different, a new calibration
procedure must be performed.
end of
calibration
CALIBRAting
T: 000°C

17
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
TECHNICAL DATA
Table 6
* In case the altitude and/or temperature of your workplace is different from the values mentioned in this manual,
contact Cristófoli by the e-mail: [email protected].
4 liters
Aluminum - 9 kg (including components)
Aluminum - 12 kg (including components)
10 cm for each side of the autoclave
30 cm
15 x 24 cm
29,1 x 26,3 x 37,3 cm
127 or 220V AC
50/60 Hz
750 Watts
178 Watts/hour
2
216 kPa (2.2 kgf/cm )
100ºC
771 KJ
15ºC to 40ºC
Up to 3500 m
Certifications ..................................................................................
Capacity ........................................................................................
Net .....................................................................................Weight
Gross ..................................................................................Weight
Overall clearance ..........................................................................
Clearance required for the movement of the door .......................
Chamber internal dimensions (W x D) ............................................
Autoclave external dimensions (W x H x D) .....................................
Voltage ..........................................................................................
Frequency ......................................................................................
Power .............................................................................................
Power consumption .......................................................................
Maximum operation pressure ........................................................
Temperature of drained water .......................................................
Total heat in joules transmitted in one hour ....................................
Proper working temperature range ................................................
Proper working altitude ...................................................................
TECHNICAL DATA CHART Baby
The Autoclaves Baby are manufactured 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.
The manufacturer reserves the right to make changes and/or improvements to this product at any moment without prior notice.

18
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
TIME X PRESSURE GRAPHS
Low Pressure Cycle
Graph 2
Graph 1
High Pressure Cycle
Pressure x Time
0,2
0,4
0,6
0,8
1
1,2
1,4
1,6
1,8
2
2,2
2,4
2
Pressure (Kgf/cm )
0
0 5 10 15 20 25
Time (Min.)
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
1,1
1,2
1,3
05 10 15 20 25 30
Time (Min.)
2
Pressure (Kgf/cm )
Pressure x Time
QUALITY CONTROL
Cristófoli equipment is tested and monitored individually, according to the parameters of the Table 5 (Page 14). Besides
the physical parameters, all autoclaves are tested with class 5 chemical indicators. The tests with biological indicators are
performed on a batch basis.
HOW TO IDENTIFY YOUR AUTOCLAVE
The purpose of the label located in the back of the
equipment is to identify the autoclave technical data.
ATTENTION! - The removal of the identification label and/or
any other labels/stickers affixed to the product will cause
automatic loss of warranty.
Note: The label presented here is just a sample model for
your reference.
Fig. 17
LOT
SN
POWER
PRODUCT: CRISTÓFOLI STEAM STERILIZATION AUTOCLAVE.
MODEL FREQUENCY -
ANVISA REGISTER -
RESPONSIBLE TECHNICIAN -
CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA
ROD BR 158 Nº 127 - CAMPO MOURÃO - PR
BRASIL - CEP 87309-650 - FONE: 55 44 3518-3401
CNPJ 01.177.248/0001-95 - INSCR. EST. 90.104.860-65
MADE IN BRAZIL
USE INSTRUCTIONS, PRECAUTIONS, CONSERVATION AND STORAGE:
SEE INSTRUCTION MANUAL.
MAXIMUM OPERATION PRESSURE -
CAPACITY -
CONFORMITY -
MODEL

19
CRISTÓFOLI
A U T O C L A V E S
I N S T R U C T I O N M A N U A L
ATTENTION! For any replacement of parts, contact your local dealer or the authorized technical assistance office. 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 may try in his/her own office.
TROUBLESHOOTING
POSSIBLE CAUSES SOLUTION
• No power ---------------------------------------------------------------------------
•The power cable of the autoclave is not properly connected to the
autoclave or to the outlet ---------------------------------------------------------
• The Start key was not pressed to turn the equipment on ---------------
• ---------------------------------------------------------The fuse has burned out
• ----------------------------------------------------Defective electronic circuit
• ;Check if there’s a power outage in your area/building
• Connect the power cable properly;
• Press the Start key, the display must show the initial information
( );brand, model and software version
• Replace the fuse which is right next to the power connector. First,
unplug the equipment, next, remove the fuse holder by pulling it out
with a small screwdriver as shown below (Fig. 18), replace the
defective fuse (in use - from the external side of the fuse holder) by
the new one (spare - located inside the fuse holder (Fig. 19). Finish
the procedure by inserting the fuse holder back into place and turn
the equipment on;
• (Page 23).See “How to Proceed when Service is Needed ”
THE AUTOCLAVE DOES NOT SWITCH ON
Fig. 18 Fig. 19
Internal fuse
(spare) External fuse
(in use)
POSSIBLE CAUSES SOLUTION
• The operator connected the autoclave to the power source but
didn’t press the Start key -------------------------------------------------------
• Nothing happens when the Start key is pressed --------------------------
• ----------------------------------------The heating element has burned out
• ------------------------------------------------------------Defective thermostat
• ----------------------------------------------------Defective electronic circuit
• Press the Start key after selecting the program on the Mode key;
• See “How to Use the Autoclave Baby ” (Page 13);
• See “How to Proceed when Service is Needed ” (Page 23).
THE AUTOCLAVE SWITCHES ON BUT DOES NOT HEAT UP
If the problem persists after the verification of all the items listed, contact your local dealer.