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ATTENTION
INDEX
PRESENTATION OF MANUAL ........................................................................02
IDENTIFICATION OF EQUIPMENT..................................................................05
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION......08
- Manmetro....................................................................................................09
- Anel de vedao.............................................................................................09
- Selo de segurana..........................................................................................09
- Painel...........................................................................................................10
- Sadas internas de vapor.................................................................................10
- Sadas externa de vapor..................................................................................10
- Mangueira sada de vapor................................................................................11
- Bandejas e suporte.........................................................................................11
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 vlvulas ..................................................................................24
PPRECAUTIONS, RESTRICTIONS AND WARNINGS ........................................24
- Conditions of transport and storage..................................................................24
- Environmental conditions of operation...............................................................24
- Sensitiveness to environmental conditions foreseeable in normal situations of use.24
- Precautions and warnings during the installation of equipment...........................25
- Recommendations for preserving the equipment.................................................25
- Precautions and warnings during the use of equipment.....................................26
- Precautions and warnings after the use of equipment.......................................27
- Precautions and warnings during the cleaning and disinfection of equipment........27
- Precautions in case of alteration in the functioning of equipment...........................28
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment.......................................28
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION ............28
- Additional procedures for reuse........................................................................28
- Preventive maintenance..................................................................................28
- Corrective maintenance..................................................................................28
- Disinfection...................................................................................................29
- Cleaning Out.................................................................................................29
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INDEX
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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
55
IDENTIFICATION OF EQUIPMENT
Description of Equipment
Its 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 250C, 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.
Its 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 its
automatically activated if an excessive pressure was detected. The doors 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 Autoclaves 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).
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
77
01
02
16
14
28A
28B
26
03
11
10
09
04
12
07
08
05
06
01
02
03
04
05
06
07
08
09
10
Autoclaves body
Front door
Manometer
Control panel
Door latch
Plug
Cord
Voltage inverter switch
Fuse holder
Steam outlet hose
Sealing ring
Vlvula anti-vaco
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.
99
4A
4D
4E
4B
4F
4G
4C
10
17
17A
11
16
18
Graduated glass
Tray holder
1111
TECHNICAL SPECIFICATIONS
Geral
Model
Autoclave 21L
Classication of Equipment as per ANVISA:
Class II
Classication 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 inammable 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 133C)
Sterilization time
16 minutes
Volume
21 Liters
Diameter of the chamber
240mm
12
TECHNICAL SPECIFICATIONS
Chambers 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 materials type
and volume, energy oscillation, etc.
Manometers tolerance variation
Divide the manometers 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:
IEC 60601-1:1988 Equipamento Eletromdico - Parte 1: Prescries gerais para
segurana;
IEC 60601-1-2:2007 Equipamento Eletromdico - Parte 1-2: Prescries gerais para
segurana: compatibilidade eletromagntica.
EN 980:2008 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
EN ISO 14971:2007 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 - Dental equipment - graphical symbols;
CISPR 11, edio 3.1 (ago/1999);
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
quantity of boxes which can be
stacked during transportation
and storage as per packaging.
Product symbols
Indicates that the device
is on.
Indicates drying
B type equipment
Position of Off.
Position of On.
Careful: It indicates an
important instruction for the
operation of the product. Not
following it can cause dangerous
malfunctioning.
Note: It indicates useful
information for operation of the
product.
Important: It indicates an
instruction of safety for operation
of the product. Not following it,
can lead to serious danger to
the patient.
15
15
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
16
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
(Legends)
01 - Products identification label
02 - Attention: Hot surface
03 - Fuse 20A (F2-F3)
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.
06 - Fuse 10A (F4)
07 - Before first use, please remove the protector film, which wraps this tray.
08 - Fuse 0,5A (F1)
09 - Maximum power per resistance: 850W - Warning: 2 Resistances
10 - Before begin the cycle, provision with 350 ml of distilled water.
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.
- Gnatus bears no responsibility for damages or accidents caused by poor installation
executed by a technician not authorized by Gnatus.
- 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 autoclaves surfaces. The inappropriate use may cause burns. GNATUS
may not be hold responsible for accidents caused by inadequate operation.
- Dont allow patients, and most specially children, to touch the autoclave.
- Periodically check that the doors 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 autoclaves door must open without difficulty.
- Always make sure that the depressurization is complete: the manometers 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.
- We recommend you to read this manual entirely. Use is as consultation manual.
The equipment doesnt need preventive maintenance, however when there is any problem
that this manual cant solve, ask for an authorized Gnatus technician.
Gnatus Company declares that the supply of the circuit scheme, list of pieces or any
other information that propitiate technical attendance for the user, can be request if there
is an agreement between the user and Gnatus Company.
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.
08
19
19
INSTALLATION OF EQUIPMENT
Installing or replacing fuses
19
09
12
11
11
10
10
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
when in contact with steam, which may cause
the external steam outlet obstruction.
16
27
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 autoclaves 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, its 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: Dont use Kraft / TNT
paper for wrapping the materials to be
sterilized (types of wrappings for autoclave
sterilization).
* Observe each countrys standards
for preparation of material to be
sterilized.
21
22
22
WARNING:
The material to be sterilized (22) cant
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 128C 2, the autoclave
will enter in the pressure sterilization mode,
with a pressure from 1,7 0,4 kgf/cm (24),
the LED (4E) will change from green (V) to
yellow (A), and it will stay that way for 16
minutes.
8) After the sterilization cycle is finished,
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
specified quantity and start the cycle again.
CUIDADO:
11) When in drying mode, the autoclaves
door must be kept ajar (25). During this
period, the user mustnt touch the internal
parts of the autoclave, so as to prevent
accidents and burns. The drying cycle lasts
half an hour. Finally, the autoclave will
emit three beeps, the green (V) led (4G) will come on, indicating the end of the cycle.
If 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.
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23
OPERATION OF EQUIPMENT
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 autoclaves front door and wait
until its 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 Gnatus authorized technician.
WARNING:
HIGH TEMPERATURE, Before carrying
out the procedure described above, wait until
its cold.
13
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 floor;
- Keep it away from water and direct sunlight, and in it original wrapping;
- Dont move it over irregular surfaces, protect it from rain and observe the maximum
stack quantity specified in the packaging;
24
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
26
- If the equipment has any abnormality, check if the problem is related to any item
listed in the topic of unforeseen events (failures, causes and solutions). If it is not possible
to resolve the problem, turn off the equipment, remove the power supply cable from the
socket and contact your representative (Gnatus).
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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
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 n Reg. MS: 317130011
Follow manufacturers directions for mixing the product.
Products composition: inorganic-acids, phosphate, acrilato de sdio. 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.
NOTE: The registration at the Ministry of Health of INOX CLEAN is performed
separately from the product described in this manual, as the INOX CLEAN is not
manufactured by Gnatus.
The materials used for wrapping the pieces to be sterilized must keep the sterilization
after the sterilization process and during storage.
These materials must:
- allow the sterilization process;
- be appropriate for the material and the sterilization process;
- allow the drying, ventilation and dispersion of the sterilizing agents;
- not have lighter and darker parts;
- be resistant to wetness, be free of holes and scratches;
- dont release particles.
30
31
31
In order to maintain the quality and the sterilization efficiency during the equipments
regular use, the BI test must be carried out routinely. To perform this test in the same place
where the autoclave is installed, it must be used the ATTEST control system, which consists
of BI test ampoules and an incubator, which allows the incubation of the test ampoule and
the verification of the final result, 48 hours later.
For more information about biological and chemical control, access www.3M.com/br/
hospitalar.
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Problem
Probable cause
Solution
- Connect the cord to the
socket.
- Power cut
- Burnt fuse(s)
- Replace fuse(s)
- Replace socket
- The autoclave cant reach - The voltage supplied is lower - An electrician must check
or maintain the pressure than the one required by the and adapt the electricity suhigh
autoclave.
pply.
- Leakage in the safety seal.
- Overloaded chamber.
33
33
WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as specied 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 Owners 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 Certicate 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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