Escolar Documentos
Profissional Documentos
Cultura Documentos
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.
PRODUCT DESCRIPTION
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.
The chamber is made of stainless steel, offering durability and resistance to permanent temperature
changes, and has a capacity of 12 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.
It comes with a hose for steam outlet, graduated glass, fuses for 127/220V~ and two perforated
stainless-steel trays, which allow the heat diffusion, thus ensuring the quality of the sterilization
process.
Note: Give preference to hand pieces and peripherals developed in accordance with requirements
of directive 93/42/EEC (with CE mark).
Quality Management System certificate in accordance to ISO 9001:2000 and ISO 13485:2003
standart, assuring that equipments are produced in base with standardized procedures, meeting the
quality continually improve.
Products manufactured in agreement with RDC 59 - ANVISA - (Sanitary Surveillance National
Agency) - with guarantees accomplishment hole to the sanitary legislation and according to BPF (Good Manufacturing Procedures), requested by Mercosul Sanitary authorities.
In order to comply with directive 93/42/EEC for CE Mark purpose, it is defined that the working life
of metallic structure this product is estimated in 10 years (life-cycle) provided that the end-user
follows the requirements and instructions of this manual.
IMPORTANT:
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.
This equipment cant be used in the presence of inflammable anesthetics or products that may
cause explosion.
After finish life-cycle of the equipment, this equipment is throw way, so it should to be destroyed
in appropriate area (according to the legislation of the country).
Observe the countrys legislation pertinent to installation and waste disposal.
NOTE:
The safety degree in the presence of inflammable anesthetic mixtures with air, oxygen or nitrous
oxide is not applicable to this equipment.
3
GENERAL DATA
Maintenance of the equipment
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.
GENERAL DATA
Caracteristics and operation
Manometer
Sealing ring
Vlvula anti-vaco
Sello de seguridad
Control panel
4A
4B
4C
4D
4E
4F
4G
GENERAL DATA
Caracteristics and operation
Steam internal outlets
17B
17
17A
11
16
WARNING:
The material to be sterilized cant be in contact
with any of the internal walls of the chamber.
18
Graduated glass
Tray holder
GENERAL DATA
15
16
14
13
01
12
02
26
03
10
09
04
08
07
06
05
01 - Autoclaves body
02 - Front door
03 - Manometer
04 - Control panel
05 - Door latch
06 - Plug
07 - Cord
08 - Voltage inverter switch
09 - Fuse holder
11
TECHNICAL SPECIFICATIONS
Tension of Feeding
127V~
+20%
-20%
220V~
+20%
-10%
Frequency
50/60Hz
Power
1600VA
Sterilization pressure
1,7 kgf/cm2 0,4 (1,3 to 2,1kgf/cm2)
Operation temperature
128C 5 (123 to 133C)
Sterilization time
16 minutos
Protection fuses
F1 - 127 / 220V~ = 0,5A
F2 and F3 - 127V~ = 15A
F2 and F3 - 220V~ = 08A
Diameter of the chamber
214 mm
Chambers depth
318 mm
Water consumption
150 - 200ml
Net Weight
23 Kg
Gross Weight
26 Kg
Degree of protection
Tipo BF
Water leak protection
IPX0
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%.
Volume
12 Liters
Standards
This equipment was designed, manufactured and tested in compliance with the following standards:
NBR-IEC srie 601-1 Equipamento Eletromdico - Parte 1: Prescries gerais para segurana;
EN 980:2003 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
ISO 14971 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 - Dental equipment - graphical symbols;
ISO 7494 - Norma dental units;
ISO 13485-2 - Quality systems - medical devices;
ISO 780 - Packaging - pictorial marking for handling goods;
ISO 11144 - Norma dental equipment - connections for suply and waste lines;
EN 60601-1 (1990);
Amendment 1 EN 60601-1 (1992);
Amendment 2 EN 60601-1 (1995);
Amendment13 EN 60601-1 (1995);
EN 60601-1-2 (2001);
NBR IEC 601-1 (1994);
Emenda 1 NBR IEC 601-1 (1994);
TECHNICAL SPECIFICATIONS
Transport and storage conditions
The equipment must be transported and stored with the following observations:
- Carefully, should not suffer drop and neither receive impact.
- With the side of the arrow upward.
- With humidity protection, not to expose to rains, sparkling of water or humidified floor.
- With maximum piling up of 04 units for storage.
Packing symbols
04
Product symbols
Indicates that the device is on
Indicates drying
TECHNICAL SPECIFICATIONS
Dimensions (mm)
10
TECHNICAL SPECIFICATIONS
Contents of the marks accessible and not accessible
11
TECHNICAL SPECIFICATIONS
Contents of the marks accessible and not accessible (Legends)
01 - Products identification label
02 - Attention: Hot surface
03 - Fuse 15A (F2-F3): Use this fuse for 127V power supply.
04 - Attention: Before turning Autoclave on, remove this cap and install the fuses.
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 08A (F2-F3): Use this fuse for 220V power supply.
07 - Before first use, please remove the protector film, which wraps this stell tray.
08 - Fuse 0,5A (F1) - 127/220V~
09 - Maximum power per resistance: 800W - Warning: 2 Resistances
INSTALLATION
08
NOTE:
For reasons of safety, the F2/F3 fuses are not
installed in factory. Therefore, these fuses must be
installed before turning the equipment on. Using a
screwdriver, loosen the fuse holders cap (09), and
place the fuses (19) in specified position. To replace
the fuses, repeat the procedure.
WARNING:
Before installing or replacing the fuses, disconnect
the equipment from the electricity supply.
NOTE:
Fuses that come with the autoclave:
- 2 fuses for 127V~ ( F2/F3 15A) + 1 reserve;
- 2 fuses for 220V~ ( F2/F3 08A) + 1 reserve;
- 1 fuse 0,5A *installed in the unit * + 1 reserve.
WARNING: After replacing the fuses for the first
time, we recommend to reserve some fuses for future
replacements.
12
19
09
INSTALLATION
Preparing the autoclave (Steps previous to operation)
Preparation
Connect and fix the rubber hose (10) using
the clamp (11) to the external steam outlet (12)
found in the autoclaves 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 flow, keep the hose straight,
avoiding the formation of bends and siphons.
12
11
10
06
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.
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 two trays,
and the biggest must be places in the upper
part.
20
16
WARNING:
Before first use, please remove the
protector film, which wraps this stell tray (27).
The female socket must be of the type used
for computers, with three pins.
Check the ground connection.
WARNING:
The ground connection is very important to
the operators safety and for the equipments
warranty. For this reason, the middle pin (ground)
cant be removed or cut.
27
13
OPERATION
How to use de autoclave
Raise the door latch, push it to the left, and
check the cleanliness of the autoclave.
Connect the energy plug (06) to the socket,
the green led (4D) in the front panel will come on,
indicating that the autoclave is on.
Using the graduated glass (21), pour inside
the autoclave the following quantities of water:
Autoclave partially full 150ml
Autoclave completely full 200ml
WARNING:
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.
All material being sterilized must be previously
washed, rinsed and dried.
21
22
22
23
14
OPERATION
How to use the autoclave (Control panel)
Press the cycle start key (4A), the
autoclave will automatically start to heat, and
you will hear 2 beeps, and a green LED (V)
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.
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:
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.
WARNING:
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.
24
IMPORTANT:
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.
25
15
OPERATION
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
MAINTENANCE
Recommendations for the dental equipment maintenance
Your Gnatus 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
Check the voltage before connecting the device to electricity supply (see page 12)
- Install your apparatus on aproper place protected by solar rays and humidity.
- The plastic parts cant be in contact with most chemical substances used in dentistry treatments,
i.e. acids, mercury, acrylic liquids, amalgams, etc.
- Dont touch the autoclaves internal surfaces when its in drying mode.
- Before turning your autoclave on, install the fuses included with the equipment.
If the voltage were changed, these fuses may be changed.
16
MAINTENANCE
Internal cleaning (sterilization chamber and trays)
To clean the interior of your equipment, sterilization chamber and trays, we recommend the use of
SDS - 1000 n Reg. MS: 3.02053-1.
Follow manufacturers directions for cleaning.
Products composition: inorganic-acids, fluoride and anionic tense-active based products.
Important: The alteration of the visual aspect inside the Autoclave tank is a normal
feature of the product owing to the heating in the region.
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: 3.02053-1.
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.
- The autoclaves filter (17A), (see page 06) shall be cleaned daily.
- In order to clean the filter, remove it via the handle (17 B), and then wash it in running water.
- Dont use sharp objects, which could damage the fabric.
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.
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.
GNATUS prohibit the use of kraft paper for wrapping
materials to be sterilized, because it isnt 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.
17
MAINTENANCE
And besides all these disadvantages, during the sterilization process, this kind of paper releases
pieces of fiber that can clog the autoclaves valves and piping system.
Observe each countrys standards related to wrapping preparation.
18
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
19
TROUBLESHOOTING
Imprevisto
Problem:
Probable Cause:
Solution:
- Burnt fuse(s)
- Replace fuse(s)
- Replace socket
- Overloaded chamber
isnt
yet
-Wait
the
depressurization
autoclave
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.
20
21
22
23