Dabi Atlante AUTOCLAVE BIOCLAVE 12 LITERS User manual

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PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
CAUTION
Technical Name: Autoclave
Trade Name: Autoclave
Model: Autoclave Bioclave 12L
Brand: Dabi Atlante
Manufacturer / Distribuitor:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Phone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
Registration ANVISA nº: 10069210082
For improved safety:
Read and understand all the instructions contained in the Instructions for Use before installation
or operation of this equipment.
Note: The Instructions for Use must be read by all persons that operate this equipment.

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INDEX
02 PRESENTATION OF MANUAL
04 IDENTIFICATION OF EQUIPMENT
04 Indication of Equipment
04 Purpose of the equipment
05 Description of Equipment
06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
09 TECHNICAL SPECIFICATIONS
09 General features
11 Dimensions
12 Packing symbols
12 Product symbols
13 INSTALLATION OF EQUIPMENT
17 EQUIPMENT OPERATION
20 PRECAUTIONS, RESTRICTIONS AND WARNINGS
20 Recommendations for preserving the equipment
20 Transportation, storage and operation
20 Sensitivity to predictable environmental conditions in ordinary situations of use
20 Precaution and warnings “during the installation” of the equipment
21 Precautions and warnings “during the use” of equipment
22 Precautions and warnings “after” the use of equipment
22 Precautions and warnings during the “cleaning and disinfection” of equipment
22 Precautions in case of alteration in the functioning of equipment
22 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation
and abandoning of equipment
23 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
23 Additional procedures for reuse
23 Cleaning
23 Disinfection
24 Internal cleaning (chamber and stainless steel trays sterilization)
24 Internal cleaning (aluminum sterilization chamber)
24 Piping cleaning
24 Cleaning the lter
25 Wrapping types for sterilization by autoclave
25 Suggested method for wrapping instruments and materials
26 Control of the pressurized and saturated steam sterilization process
26 Maintenance of the qualication
26 Testing procedure using biological indicators
26 Attest biological monitoring system for steam sterilization process
26 Preventive Maintenance
26 Corrective Maintenance
27 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
27 EQUIPMENT’S WARRANTY
27 FINAL CONSIDERATIONS

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IDENTIFICATION OF EQUIPMENT
Dear Customer
This manual is a general presentation of your product and it will give you important details to help
you to solve possible problems.
Please, read it and keep this with you.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized professional
(certied professional, according to the legislation of the country) and following the instructions of
the manual. The operation of the equipment required, for the professional, the utilization of correct
instruments and it should to be in perfect conditions of the use, and to protect the professional,
the patients and others, in the eventual danger situation.
IDENTIFICATION OF PRODUCT
Purpose of the equipment
Sterilization by autoclave has the purpose of destroying microorganism under high pressures and
temperatures, aiming to prevent infections and contaminations.
Technical Name: Autoclave
Trade Name: Autoclave
Model: Autoclave Bioclave 12L

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Principles and fundamentals applied to the product functioning
Sterilization by autoclave consists of exposing the contaminated material to steam under high
pressures and temperatures, for the time needed. Humidity and heat irreversibly denature structural
enzymes and proteins, destroying microorganisms.
The process includes compression and decompression cycles as to provide easier contact between
the steam and the contaminated material. The pressure value ranges from 1.3 to 2.1 kgf/cm2 and
temperatures from 123°C to 133°C.
*Optional
Description of Equipment
It’s an autoclave for sterilization by vapor, modern design, easy to operate, ideal for dentistry oces
(general practice, endodontia, pediatric dentistry, orthodontics, prosthesis, operative dentistry and
esthetics).
Its structure is made in carbon steel, with surface treatment through nanotechnology.
Smooth high gloss epoxy based paint polymerized at 250ºC with corrosion resistant treatment and
cleaning materials.
Its chamber is made of stainless steel*or aluminum*, oering long durability and resistance to the
constant variance of temperature, with capacity for 12 Liters.
It’s internally coated with heath isolating material, which optimizes its operation and reduces the
energy consumption.
It features an anti-vacuum valve, which prevents the door and safety seal from blocking, and it’s
automatically activated if an excessive pressure was detected. The door’s sealing system is made of
high-performance silicone, resistant to temperature and pressure changes, and its exibility allows
the perfect sealing between surfaces in contact, preventing leakage.
The control panel contains LED and function buttons, graduated manometer for temperature and
pressure, ergonomic handle with automatic depressurization safety system, which prevents accidents
in case of unintentional opening.
Accompanied by a hose for outlet of steam, graduated cup, spare fuses and 2 trays made of stainless
steel or aluminum totally pierced to allow a good circulation of heat, ensuring excellent quality
in the sterilization.
Basic Principles of Autoclave’s Operation:
• Water supply for autoclave.
• Heating: Water steam followed by gradual increase of pressure.
• Sterilization: High pressures and temperatures through approximately 16 minutes.
• Depressurization: Steam release and relief of autoclave pressure.
• Drying: Material drying and cooling until achieving a temperature which allows handling.
IDENTIFICATION OF EQUIPMENT

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
The contents of this page are of an informative nature, the equipment being able to dier
from that illustrated. So, upon acquiring the product check the technical compatibilty
between equipment, coupling and accessories.
01 - Autoclave’s body
02 - Front door
03 - Manometer
04 - Control panel
05 - Door latch
06 - Plug input power cable
07 - Voltage selector switch
08 - Fuse holder
09 - Master key
*Optional
internal view back view
10 - Steam outlet hose
11 - Hose’s xing clamp
12 - Steam external outlet
13 - Anti-vacuum valve
14 - Sealing ring
15 - Safety seal
16 - Trays
*17 - Sterilization chamber "available in stainless steel or
aluminum"

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Accessories which accompany the Autoclave
Attention
- The use of any part, accessory or material not specied or provided in these use
instructions is of entire responsibility of the user.
01. Tray holder:
It’s a device used to handle trays, avoiding direct contact with the operator.
02. External steam outlet’s hose:
This accessory must be connected and xed to the external steam outlet using a clamp. It takes steam
out.
03. Graduated glass:
It’s used to dose the quantity of distilled water needed for each sterilization cycle.
04. Trays and support:
Support with 2 trays, to keep materials to be sterilized from contact with chamber, bottom and
water sidewalls
WARNING:
The material to be sterilized can’t be in contact with any of the internal walls of the chamber.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

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Caracteristics and operation
Manometer
It’s used for temperature and pressure control, and its graduation range
from 0 kgf/cm² to 4.0 kgf/cm² and from 100ºC to 152 ºC.
Manometer’s tolerance variation
Divide the manometer’s scale by three equal parts.
For the rst part, the tolerance is 3%, for the second part is 2%, and
for the third is 3%.
Sealing ring
Besides sealing the door, it also works as a safety device, relieving
chamber’s internal pressure in casa of overpressure.
If the sealing ring were moved from its place, call a authorized technician
to carry out the maintenance of the equipment.
Safety seal and anti-vacuum valve
Placed in the internal part of the door, they diminish the pressure in the chamber, in case it exceeds.
The anti-vacuum valve has the same function, and it also reduces the pressure of the chamber if
it were negative (vacuum).
NOTE:
If during the sterilization procedure the valves were opened, the operator can reset them.
However, the appropriate cooling time must be observed in order to prevent accidents.
If the valves were opened repeatedly, call a authorized technician.
NOTE: Execute the replacement of the safety seal and anti-vacuum valve within the period “of 36
months”. If it is necessary to do it before the period indicated, request the presence of an authorized
technician.
Anti-vacuum
valve
Security
seal
Control panel
Found in the front part of the autoclave, it contains all
controls necessary to operate the equipment.
4 A - Cycle start
4 B - Drying
4 C - Cancel
4 D - Equipment ON
4 E - Heating / Sterilization
4 F - Drying
4 G - Cycle end
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

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Caracteristics and operation
Steam internal outlets
They’re holes in the rear wall of the
internal chamber (17), they take the
steam to the pressure control valve.
Note: In the lower hole there’s a
protective lter (A), it prevents solid
residues from entering the steam
outlet.
External steam outlet
The 5/16” hose tting, found in the
autoclave rear part, takes the steam
outside.
Model
Autoclave 12L
Power Supply Voltage
127V~ (100-140V~)
220V~ (198-264V~)
Frequency
50/60 Hz
Power
1600W
Electric shock protection type
Class one equipment - Applied Part Type B
Mode of Operation
Continuous operation
TECHNICAL SPECIFICATIONS
General features
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

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TECHNICAL SPECIFICATIONS
Protection against harmful water penetration or particulate material
IPX0
Sterilization pressure
1,7 kgf/cm2 ± 0,4 (1,3 to 2,1kgf/cm2)
Operation temperature
128 °C ± 5 (123 to 133ºC)
Sterilization time
16 minutes
Volume
12 Liters
Diameter of the chamber
214mm
Chamber’s depth
318mm
Water consumption per cycle
150 - 200ml
Net Weight / Gross Weight
23 Kg / 26 Kg
Fuse of Protection
F1 = 0,5A / F2 and F3 = 15A / F4 = 08A
Full cycle time
60 minutes
These values are approximate, they may change depending on the material’s type and volume,
energy oscillation, etc.
Manometer’s tolerance variation
Divide the manometer’s scale by three equal parts. For the rst part, the tolerance is 3%, for the
second part is 2%, and for the third is 3%.
Warning
Pay attention while using this equipment together with other movable equipment, in order
to avoid collisions.
Attention
The materials used to produce the equipment are Biocompatible.
*Optional

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Dimensions (mm)
*For installation of the Autoclave in niches / cabinets, consider the addition of 50mm in the total
length of the product.
TECHNICAL SPECIFICATIONS

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Packing symbols
Product symbols
It determines the maximum
quantity of boxes which can be
stacked during transportation and
storage “as per packaging”.
Packing to be transported and /
or stored avoiding humidity, rains
and wet oor.
Packing to be transported and /
or stored with the harrows up.
The packing must be stored and
transported away from direct sun
light exposure.
Packing to be transported and / or
stored with care (should not suer
drop and neither receive impact).
Temperature limit for the packing
to be stored or transported.
Applied part type B.
Grounding (at several points of the
equipment) indicates the condition
of being grounded.
General warning:
If the instructions are not properly
followed, the use can lead to
damage to the product, user or
patient.
Note:
It indicates useful information for
operation of the product.
Turned o position. Turned on position.
TECHNICAL SPECIFICATIONS

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Refer to the instruction manual. Indicates cycle end
Indicates that the device is in
heating mode
Indicates that the device is in
sterilization mode
Indicates cycle cancellation Indicates drying
Indicates cycle start Indicates that the device is on
Product symbols
INSTALLATION OF EQUIPMENT
The installation of this equipment requires the necessity of specialized technical assistance
(Alliage). Ask for the presence of a Alliage representative technician at the nearest seller, or
through the Alliage Service Center: + 55 (16) 3512-1212.
Note
That information are also part of the Installation and Maintenance Manual of the equipment
that is found with the Alliage authorized technical representative.
Important safety considerations
- Never touch the steam external outlet and, after the sterilization is nished, never touch the
internal autoclave’s surfaces. The inappropriate use may cause burns. Alliage may not be hold
responsible for accidents caused by inadequate operation.
- Don’t allow patients, and most specially children, to touch the autoclave.
- Periodically check that the door’s door latch is correctly in place before operation. If this procedure
were not observed, the sealing ring may come o.
- Before using the autoclave, verify that the internal chamber is clean, also check if the protection
lter is completely clean, free of residues.
TECHNICAL SPECIFICATIONS

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INSTALLATION OF EQUIPMENT
- When raising the door latch, the autoclave’s door must open without diculty.
- Always make sure that the depressurization is complete: the manometer’s needle must be in
the “0” (zero) position. Never use force to open the autoclave! - If one of the safety devices were
activated (unexpected steam leak) usually caused by the internal steam outlet blockage or by an
obstruction in the pressure control valve, wait until the complete depressurization before switching
the autoclave o.
- Use only the hose supplied by Alliage, or one similar, so as to prevent if from melting when in
contact with steam, which may cause the external steam outlet obstruction.
- We recommend you to read this manual entirely. Use is as consultation manual.
Protection against current overload
The equipment is protected from current overload by fuses.
Special precautions and installation conditions
- Install the autoclave on a firm and leveled surface,
approximately at 80 cm. from the oor. Leave enough space for
handling the materials to be sterilized.
- Check if the grounding conductor is correctly connected.
- Never use cord extensions, connectors or voltage transformers.
- It is necessary to use a socket higher than 10A, in which a
standardized plug will be connected to, according to ABNT NBR
14136 Regulation, as the picture bellow shows:
Preparing the autoclave (Steps previous to operation)
Voltage change
For your safety, the autoclave is factory-set to 220V. For this reason, you must check the suitability
of the electricity supply. If the electricity network available is 127V~, change the voltage switch.
Change the voltage switch according to the local electricity network (127 or 220 V).
Warning
Don’t change the voltage while the device is on. Then, connect the
equipment to the electricity supply and proceed as follows.

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Replacing the fuses
With a Phillips screwdriver, unscrew the lid (09) of the electronic board compartment, then remove
the broken fuse and place the new fuse (19) in the position indicated.
WARNING:
Before installing or replacing fuses, unplug the electric power cord.
uses that come with the Autoclave:
- 2 15A fuses installed in the equipment (F2/F3) + 1 spare;
- 1 08A fuse installed in the equipment (F4) + 1 spare;
- 1 0.5A fuse installed in the equipment (F1) + 1 spare.
WARNING:
- After performing the rst replacement, it is advisable to always have spare fuses at hand.
- All fuses must be installed independently from the grid voltage.
Preparing the autoclave
Connect and x the rubber hose (10) using the clamp
(11) to the external steam outlet (12) found in the
autoclave’s rear part. The other end must be placed in
a water container (20) or in a drainage which can stand
high temperatures.
In order to prevent the obstruction of water and steam
ow, keep the hose straight, avoiding the formation of
bends and siphons.
WARNING
Use only the hose supplied by Dabi Atlante, or one
similar, so as to prevent if from melting when in
contact with steam, which may cause the external
steam outlet obstruction.
INSTALLATION OF EQUIPMENT

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Open the front door raising the door latch, then push it
to the left and check if the trays (16) are in their place.
There must be three trays, and the biggest must be places
in the upper part.
Warning
- Before rst use, please remove the protector
lm, which wraps this tray (27).
- The female outlet should be a grounded bipolar
type - three prong (2 at and 1 round).
Verify that the ground wire is properly connected.
ATTENTION:
The ground connection is very important to
the operator’s safety and for the equipment’s
warranty.
For this reason, the middle pin (ground) can’t be
removed or cut.
INSTALLATION OF EQUIPMENT

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1) Connect the energy plug to the socket.
2) Raise the door latch, push it to the left, and check
the cleanliness of the autoclave.
3) Using the dosing cup (21), pourinside the autoclave
the following quantities of water:
Autoclave partially full - 150ml.
Autoclave completely full - 200ml.
Use only distilled water or demineralized. If you use
other water than distilled, it may cause the
obstruction of the internal valves and stain the
instruments, and the warranty will not be applicable.
4) All material being sterilized must be previously
washed, rinsed and dried.
5) Close the autoclave’s door pushing it against
the tank, pushing the door latch to the right and
then lowering it. Check that it is correctly closed
(23). In order to avoid accidents and burns, it’s very
important that the door is well closed.
6) Green led (4D) in the front panel will come on,
indicating that the autoclave is on.
WARNING:
Don’t use “Kraft / TNT”
paper for wrapping the materials to besterilized
(types of wrappings for autoclave sterilization, see
page 25).
Observe each country’s standards for preparation of
material to be sterilized.
Distribute the wrappings at equal distances (22)
leaving enough space between them so as to allow
the steam to circulate.
ATTENTION:
The material to be sterilized (22) can’t be in contact
with any of the internal walls of the chamber.
OPERATION OF EQUIPMENT

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7) Press the cycle start key (4A), the autoclave will
automatically start to heat, and you will hear 2 beeps,
and a green LED (V1) will come on. The heating time
depends on the quantity of the material to be sterilized.
After the heating has reached a temperature of 128ºC
±5, the autoclave will enter in the pressure sterilization
mode, with a pressure from 1,7± 0,4 kgf/cm² (24), the LED
(4E) will change from green (V1) to yellow (A), and it will
stay that way for 16 minutes.
8) After the sterilization cycle is nished, the valve
will automatically open and the autoclave will be
depressurized. After three minutes you will hear ten
beeps. The blue LED (4F) will come on, indicating the
drying mode. In this moment, the door shall be opened
and it must remain ajar (25) so as to dry the sterilized
material.
IMPORTANT:
9) If it was necessary to stop the sterilization cycle, press
the cycle interruption key (4C). Wait until the autoclave
is completely depressurized before opening the door.
10) In case of power cut, the operation of the autoclave
will be interrupted, the yellow (4G) LED will come on and
it will remain blinking, activating the discharge valve for
3 minutes. During this time, no function will be available.
When the power were restored, check the water level,
if necessary, replenish the specied quantity and start
the cycle again.
WARNING:
11) When in drying mode, the autoclave’s door must be
kept ajar (25). During this period, the user mustn’t touch
the internal parts of the autoclave, so as to prevent
accidents and burns. The drying cycle is 30 minutes, for
aluminum tank autoclaves the time is 18 minutes. Finally,
the autoclave will emit three beeps, the green (V2) led
(4G) will come on, indicating the end of the cycle.
CIf the material were not completely dry, you can select
the extra dry function (4B).
Leaving the door ajar (25) press the (4B) key, the blue
(4F) LED will come on, indicating the start of a new drying
cycle that will last 30 minutes. If the operator notes that
the material is already dry, he can cancel the cycle by
pressing the (4C) key.
OPERATION OF EQUIPMENT

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Resetting the valves (safety seal and anti-vacuum valve)
If the valve (13) were opened during the sterilization process, the operator can reset it. Open the
autoclave’s front door and wait until it’s cold. Proceed as described in the drawing, pressing them
until they go back to their original position.
If the valves were opened repeatedly, call a authorized technician.
WARNING:
HIGH TEMPERATURE, Before carrying out the procedure described above, wait until it’s cold.
OPERATION OF EQUIPMENT

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Recommendations for preserving the equipment
Your equipment has been designed and developed according to the standards of modern techology.
Similarly to other kinds of equipment, it requires special care, which is many times neglected due
to several reasons and circunstances. Therefore, here are some important reminders for your daily
routine. Try to follow these simple rules, which will save you a lot of time and will avoid unnecessary
expenses once they start making part of your working procedure.
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Transportation, storage and operation
This equipment must be transported and stored observing the following directions:
- Avoid falls and impacts;
- Keep it dry, do not expose it to rain, water drops or wet oor;
- Keep it away from water and direct sunlight, and in it original wrapping;
- Don’t move it over irregular surfaces, protect it from rain and observe the maximum stack quantity
specied in the packaging;
Environmental condition for transportation or storage:
- Room temperature range for transportation or storage -29ºC to +60ºC.
- Relative humidity range for transportation or storage 20% to 90%.
- Atmospheric pressure range 500hPa to 1060 hPa (375 mmHg to 795 mmHg).
Environmental operation condition:
- Room temperature range for functioning +10ºC to +40ºC.
- Recommended room temperature range +21ºC to +26ºC.
- Relative humidity range for functioning 30% to 75%.
- Atmospheric pressure range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).
- Operation altitude: ≤2000m.
Attention
The Equipment maintains its condition of safety and ecacy, provided that it is maintained (stored)
as mentioned in this instruction of use. Thus, the equipment will not lose or alter its physical and
dimensional features.
Sensibility to predictable environmental conditions in regular use conditions
- The equipment has been planned not to be sensitive to interference such as magnetic elds,
external electrical factors, electrostatic discharge, pressure or variance of pressure, provided that
the equipment is installed, maintained, clean, preserved, transported and operated as per this
instruction for use.
Precaution and warnings “during the installation” of the equipment
- This equipment can only be unpacked and installed by an Alliage authorized technician, under the
penalty of losing the warranty, as only them possess the information, the proper tools and the
required training for carrying out this task.
- Manufacturer does not take this responsibility for damage or accidents caused due to a bad
installation performed by a technician non-authorized by Alliage.
- Only after the equipment is installed and properly tested by the Alliage authorized technician, it will
be ready to start the working operations.
- Install the autoclave on a rm and leveled surface, approximately at 80 cm. from the oor. Leave
enough space for handling the materials to be sterilized.
- Install the unit in a place where it will not be damaged by the pressure, temperature, humidity, direct
sunlight, dust, salts.