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Brand: GNATUS
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - gnatus@gnatus.com.br
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
ATTENTION
For greater safety:
Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.
2
INDEX
PRESENTATION OF MANUAL ........................................................................02
IDENTIFICATION OF EQUIPMENT..................................................................05
INSTALLATION OF EQUIPMENT.....................................................................12
- Standards applied..........................................................................................13
- Dimension.....................................................................................................14
- Symbologies of packaging...............................................................................15
- Symbologies of product...................................................................................15
- Contents of the accessible and inaccessible markings..........................................16
INSTALLATION OF EQUIPMENT.....................................................................17
OPERATION OF EQUIPMENT..........................................................................22
- How to use de autoclave.................................................................................22
- How to use the autoclave (Control panel)..........................................................23
- Rearmando as válvulas ..................................................................................24
33
INDEX
- Internal cleaning (chamber and stainless steel trays sterilization).........................28
- Internal cleaning (aluminum sterilization chamber).............................................29
- Limpeza das tubulações..................................................................................29
- Piping cleaning...............................................................................................29
- Wrapping types for sterilization by autoclave......................................................29
- Suggested method for wrapping instruments and materials..................................31
- Control of the pressurized and saturated steam sterilization process......................32
- Maintenance of the qualification.......................................................................32
- Testing procedure using biological indicators......................................................32
- Attest biological monitoring system for steam sterilization process........................32
WARRANTY OF EQUIPMENT...........................................................................34
FINAL CONSIDERATIONS...............................................................................34
4
DESCRIPTION OF THE EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. 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.
Identification
Technical Name: Endodontic Sterilizero
Brand: GNATUS
Trade Name: Autoclave Bioclave 21L
55
IDENTIFICATION OF EQUIPMENT
Description of Equipment
It’s an autoclave for sterilization by vapor, modern design, easy to operate, ideal for dentistry offices
(general practice, endodontia, pediatric dentistry, orthodontics, prosthesis, operative dentistry and
esthetics).
Its structure is made of carbon steel, with high-shine epoxi paint, polymerized at 250ºC, with phosphate
treatment resistant to corrosion and cleaning materials.
Its chamber is made of stainless steel or aluminum, offering long durability and resistance to the
constant variance of temperature, with capacity for 21 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 flexibility 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, fuses for voltage of 127/220 V~ and 3
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.
Quality Management System certificate in accordance to EN ISO 9001/2008 e EN ISO
13485/2003,standart, assuring that equipments are produced in base with standardized
procedures.
Products manufactured in agreement with RDC 59/00 - ANVISA (Sanitary Surveillance
National Agency).
6
IDENTIFICATION OF EQUIPMENT
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certified 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.
Equipment Purpose
Sterilization by autoclave has the purpose of destroying microorganism under high
pressures and temperatures, aiming to prevent infections and contaminations.
77
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
15
16
14
13
28A
01 28B
12
11
02
26 10
03
09
07
04
08
05
06
8
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
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 first 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
Gnatus authorized technician to carry out the maintenance
of the equipment.
Sello de seguridad
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 Gnatus 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 Gnatus technician.
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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
Caracteristics and operation
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 4A
4 G – Cycle end 4D
4E
4B
4F
4G
4C
10
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
Accessories which accompany the Autoclave
External steam outlet’s hose
This accessory must be connected and fixed to the
external steam outlet using a clamp (11). It takes steam
out.
11
Graduated glass
It’s used to dose the quantity of distilled water
needed for each sterilization cycle (350ml - 380ml)
Tray holder
It’s a device used to handle trays, avoiding direct
contact with the operator.
1111
TECHNICAL SPECIFICATIONS
Geral
Model
Autoclave 21L
Classification of Equipment as per ANVISA:
Class II
Classification of Equipment as per standard IEC 60601-1:
Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1)
Degree of safety of application in presence:
Equipment not suited to an anesthetic mixture inflammable with air, oxygen or nitrous
oxide.
Mode of Operation
Continuous operation
Protection against harmful water penetration
IPX0
Power Supply
Power Supply Voltage
100-140V~
198-264V~
Frequency
50/60 Hz
Power
1700W
Other Specifications
Sterilization pressure
1,7 kgf/cm2 ± 0,4 (1,3 a 2,1kgf/cm2)
Operation temperature
128 °C ± 5 (123 a 133ºC)
Sterilization time
16 minutes
Volume
21 Liters
Diameter of the chamber
240mm
12
TECHNICAL SPECIFICATIONS
Chamber’s depth
450mm
Water consumption
350 - 380ml
Net Weight / Gross Weight
30 Kg 33 Kg
Fuse of Protection
F1 = 0,5A
F2 e F3 = 20A
F4 = 10A
Complete cycle
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 first part, the tolerance is 3%,
for the second part is 2%, and for the third is 3%.
Standards applied
This product was tested and approved in compliance with the following standards:
EN 980:2008 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
The Equipment maintains its condition of safety and efficacy, provided that
it is maintained (stored) as mentioned in this instruction for use. Thus, the
equipment will not lose or alter its physical and dimensional features.
13
13
TECHNICAL SPECIFICATIONS
Dimensions (mm)
14
TECHNICAL SPECIFICATIONS
Packing symbols
It determines the maximum Packing to be transported and
quantity of boxes which can be / or stored avoiding humidity,
stacked during transportation rains and wet floor.
and storage “as per packaging”.
Product symbols
Careful: It indicates an
Indicates cycle cancellation important instruction for the
operation of the product. Not
following it can cause dangerous
malfunctioning.
B type equipment
15
15
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
16
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
(Legends)
01 - Product’s identification label
05 - Attention: This equipment leaves the manufacturer with the selecting key of voltage
at 220V~ being so be sure that the net is compatible before connecting. If the voltage
will be 127V~ please invert the voltage selection switch position.
07 - Before first use, please remove the protector film, which wraps this tray.
INSTALLATION OF EQUIPMENT
The installation of this equipment requires specialized technical assistance
(Gnatus).
OBS: These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized Gnatus
technician.
- This equipment shall only be able to be unpacked and installed by a Gnatus authorized
technician, under penalty of losing the warranty, as only (s)he has the information, suitable
tools and training required to execute this task.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.
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17
INSTALLATION OF EQUIPMENT
Important safety considerations
- Never touch the steam external outlet (12) and, after the sterilization is finished, never
touch the internal autoclave’s surfaces. The inappropriate use may cause burns. GNATUS
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 off.
- Before using the autoclave, verify that the internal chamber is clean, also check if the
protection filter is completely clean, free of residues.
- When raising the door latch, the autoclave’s door must open without difficulty.
- 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 off.
- Use only the hose supplied by GNATUS, or one similar, so as to prevent if from melting
when in contact with steam, which may cause the external steam outlet obstruction.
18
INSTALLATION OF EQUIPMENT
Special precautions and installation conditions
- Install the autoclave on a firm and leveled surface, approximately at 80 cm. from the
floor. 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:
NOTE: This information are also contained in the Installation and maintenance manual
owned by the GNATUS authorized technician.
WARNING:
Don’t change the voltage while the device is
on. Then, connect the equipment to the electricity 08
supply and proceed as follows.
19
19
INSTALLATION OF EQUIPMENT
Installing or replacing fuses
19
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.
09
WARNING:
Before installing or replacing fuses,
unplug the electric power cord.
WARNING:
- After performing the first replacement, it is advisable to always have spare fuses at
hand.
- All fuses must be installed independently from the grid voltage.
20
20
INSTALLATION OF EQUIPMENT
Preparing the autoclave (Steps previous to operation)
WARNING:
• Use only the hose supplied by GNATUS,
or one similar, so as to prevent if from melting 16
when in contact with steam, which may cause
the external steam outlet obstruction.
21
21
OPERATION OF EQUIPMENT
How to use de autoclave
1) Connect the energy plug (06) to the
socket.
2) Raise the door latch, push it to
the left, and check the cleanliness of the
autoclave.
3) Using the graduated glass (21), pour
inside the autoclave the following quantities
of water:
Autoclave partially full – 350ml
Autoclave completely full – 380ml
Use only distilled water. 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:
• The material to be sterilized (22) can’t
be in contact with any of the internal walls
of the chamber.
23
22
OPERATION OF EQUIPMENT
How to use the autoclave (Control panel)
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 ±2, 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 (V) to
yellow (A), and it will stay that way for 16
minutes.
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.
23
23
OPERATION OF EQUIPMENT
Resetting the valves (safety seal and anti-vacuum valve)
WARNING:
HIGH TEMPERATURE, Before carrying
out the procedure described above, wait until 13
it’s cold.
24
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Precautions and warnings “during the installation” of quipment
- The equipment should only be installed by Gnatus authorized technical assistance or
technicians.
- Check that the socket in which the device will be connected has a ground connection.
According to the ABNT standard, this is essential for the safe operation of the system;
- Position the equipment in a place where it will not get wet.
- Install the equipment in a place where it will not be damaged by pressure, temperature,
humidity, direct sunlight, dust, salts, or sulfur compounds.
- This equipment was not planned for use in an environment where vapors, anesthetic
mixtures inflammable with air, or oxygen and nitrous oxide can be detected.
- Check the voltage of the equipment at the moment of executing the electrical
installation.
- The equipment must be grounded correctly.
- Before the first use and/or after long interruptions from work such as vacations, clean
and disinfect the equipment; eliminate air and water deposited in the internal hoses.
OBS: These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized
Gnatus technician.
Important recommendation
The form and weight of each insert are determining factors for obtaining a maximum
performance from the generator of scalers. The operator should pay all due attention to
these two features to ensure the maintenance of the best performances of the unit. However,
we recommend that the structure of the insert is not altered (filing it or twisting it), just as
the aging of an insert leads to its original features being altered, making it inefficacious.
Any insert which has been damaged by use or by accidental impact must be replaced.
25
25
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Precautions and warnings “during the use” of equipment
- Never touch the steam external outlet and, after the sterilization is finished, never
touch the internal autoclave’s surfaces. The inappropriate use may cause burns. GNATUS
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 off.
- Before using the autoclave, verify that the internal chamber is clean, also check if the
protection filter is completely clean, free of residues.
- When raising the door latch, the autoclave’s door must open without difficulty.
- 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 off.
- Before turning your autoclave on, install the fuses included with the equipment.
If the voltage were changed, these fuses may be changed.
- Use only the hose supplied by GNATUS, 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.
A GNATUS PROIBE:
1) The use of “kraft” paper for wrapping materials to be
sterilized, because it isn’t manufactured with this purpose.
Its use has many disadvantages when compared to other
materials, such as irregularities and uneven texture, what
affects the resistance, turning it inadequate for its use as
microbial barrier. Besides, it frequently contains starch,
colorings and other toxic products that can stain the parts.
It can also contain Alkylthiophene, which, during the
sterilization process may give off an unpleasant smell, which
causes nausea and headache if breathed.
And besides all these disadvantages, during the
sterilization process, this kind of paper releases pieces
of fiber that can clog the autoclave’s valves and piping
system.
2) Submit the autoclave sterilization process in the TNT tissue used as primary packaging
material for sterile products and / or drapes. TNT is the acronym for (non-woven fabric), that
is, a fabric produced from disoriented fibers that are bonded and fixed, not going through
the most common textile processes that are spinning and weaving.
This tissue is not manufactures to be used in autoclaves, as TNT has polypropylene as
the main raw material, which is similar to a thermoplastic.
WARNING: Gnatus is not responsible for any equipment damage or sterilization process
due to the use of kraft and/or TNT paper.
26
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Precautions and warnings “during the use” of equipment
NOTE: GNATUS recommend the use of surgical paper, because the microbial
barrier of this material is above 90%, and it permits the operator to visually check the state
of the instruments. It also has chemical indicators of the process.
27
27
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Additional procedures for reuse
The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing
to be cleaned and disinfected.
Preventive Maintenance
The equipment should be calibrated routinely, as per the legislation in force in the country.
But never with a period exceeding 3 years.
In order to protect your equipment, seek Gnatus technical assistance for periodic revisions
of preventive maintenance.
Corrective Maintenance
If the equipment has any abnormality, check if the problem is related to any of the items
listed in the item Unforeseen Events (situation, cause and solution).
If it is not possible to solve the problem, turn off the equipment, and request Gnatus
technical assistance.
Disinfection
Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.
Never use corrosive disinfectants or solvents.
28
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Cleaning
The cleaning procedure below should be executed at the start of the
working day and after each patient.
Always turn off the main switch before executing the procedures of
daily maintenance.
29
29
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Internal cleaning (aluminum sterilization chamber)
We recommend cleaning your autoclave monthly with a descaling product (HIGINDOOR
207 Reg. MS: 310030079) which cleans the chamber. Apply a solution diluted at a 1:5 (1
part of the product to 5 parts of water) of HIGINDOOR 207 in the area to be cleaned, leaving
it to act for 5 minutes, and drying it with a moist cloth. (check the instructions of use of
the product with the manufacturer).
Piping cleaning
Monthly the internal components of the autoclave must be cleaned and disinfected.
To clean the interior of your equipment, tubing, valves and filters, we recommend the
use of “INOX CLEAN” nº Reg. MS: 317130011
Follow manufacturer’s directions for mixing the product.
Product’s composition: inorganic-acids, phosphate, acrilato de sódio. Mix the product
following the instructions given by the manufacturer.
Pour the solution in the chamber and start the sterilizing cycle. Repeat the sterilizing
operation using only distilled water. When these cycles are finished, remove the remnants
of the cleaning solution using a clean piece of cloth moistened with water.
30
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Suggested method for wrapping instruments and materials.
The wrapping technique for wrapping instruments and/
or materials before the sterilization process is described in
the following sequence of illustrations.
This folding sequence isn’t unintentional. It makes its
handling easier and it prevents contamination when the
wrapping is opened.
F - Take the “c” corner and insert them under the folds
made in C, D and E;
31
31
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Control of the pressurized and saturated steam sterilization
process
All Autoclaves are tested at the production line following a procedure that ensures the
equipment’s efficiency to provide safe and sterilized articles.
32
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
Upon coming across any problem in operation, follow the instructions below to check
and repair the problem, and/or get in touch with your representative.
- The autoclave can’t reach - The voltage supplied is lower - An electrician must check
or maintain the pressure than the one required by the and adapt the electricity su-
high autoclave. pply.
- The door latch isn’t in posi- - Place the door latch pushing
tion, causing leakage. it downwards
- The autoclave doesn´t - The ON/OFF switch is OFF. - Turn the ON/OFF button
warm. ON.
-The autoclave’s door can’t -The autoclave isn’t yet de- -Wait the autoclave depres-
be opened pressurized surization
33
33
WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as specified below; provided that the defect has occurred in normal conditions of use and
that the equipment has not remained stored for more than 06 months counting from the
issue date of the sales document until the date of the actual installation.
- WARRANTY TERMS: Verify the guarantee certificate;
- LOSS OF THE WARRANTY:
A) Attempt to repair using an inadequate tool or by unauthorized technicians;
B) Installation of the equipment by an unauthorized technician;
C) Damage arising from inappropriate storage or signs of infringement;
D) Incorrect use of the equipment;
E) Use of a cleaning product not indicated by the factory;
F) Falls or blows which the equipment may undergo or lack of observation of an compliance
with the guidelines of the Owner’s Manual, which was delivered with the present document,
together with the equipment. Repair or replacement of parts during the warranty period
shall not extend the validity term of their warranty.
- This warranty doe snot exempt the customer from paying the service charge for the visit
and the travel expenses of the technician, except when the customer sends the equipment
to execute the maintenance inside the establishment of the technical assistance.
“Consumer Defense Code - art. 50, unique paragraph”.
- The Warranty Certificate comes with the product and must be filled in upon the date
of installation by the Gnatus Authorized Technician.
- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.
- Check the warranty term attached to this manual.
FINAL CONSIDERATIONS
The most important aspect related to equipment care is that concerning spare parts.
To guarantee the life span of your equipment, use only original Gnatus spare parts.
They are sure to follow the technical specifications and standards required by Gnatus.
We must also point out to you our chain of authorized dealers. Only dealers that make
part of this chain will be able to keep your equipment constantly new for they count on
technical assistants who have been trained and on spedific tools for the correct maintenance
of your equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
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