PRESENTATION OF MANUAL

INSTRUCTIONS FOR USE

EQUIPMENT:

Technical Name: Endodontic Sterilizer

Trade Name: Autoclave Bioclave 12L

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

Registration ANVISA Nº: 10229030042

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

Product Description................................................................................................................04
Important Safety Considerations............................................................................................05
General Data .........................................................................................................................06
Technical Specifications ........................................................................................................10
Symbols.................................................................................................................................11
Dimensions............................................................................................................................12
Installation..............................................................................................................................14
Operation...............................................................................................................................14
Maintenance...........................................................................................................................16
Precautions............................................................................................................................18
Cleaning ................................................................................................................................18
Control of the sterilization process.........................................................................................21
Troubleshooting.....................................................................................................................22
Final Considerations .............................................................................................................23

3
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
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 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 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 2
trays made of stainless steel or aluminum totally pierced to allow a good circulation of heat, ensuring
excellent quality in the sterilization.
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 accomplishiment to the sanitary legislation according to BPF (Good Manufacturing
Procedures). In order to comply with directive 93/42/EEC for CE Mark purpose, it is defined that the life
span of this product is estimated in 05 years provided that the enduser 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 can’t 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 country’s 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.

4
WARRANTY OF THE EQUIPMENT
This warranty covers product’s manufacturing faults for the warranty period and standards specified
on the Warranty Certificate. The Warranty Certificate is attached to product, and must be completed by
the Authorized Technician when equipment is installed.
Doubts and information: GNATUS Call center (55-16) 2102-5000.

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 filter (17A) 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.

GENERAL DATA
Maintenance of the equipment
The equipment doesn’t need preventive maintenance, however when there is any problem that
this manual can’t solve, ask for an authorized Gnatus technician.

List of pieces and circuit scheme

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.

Protection against current overload

The equipment is protected from current overload by fuses.

5
GENERAL DATA

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.

Safety seal and anti-vacuum valve

Placed in the internal part of the door, they Válvula anti-vacío
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
Sello de seguridad
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.

Control panel
Found in the front part of the autoclave, it
contains all controls necessary to operate the
equipment.
4 A – Cycle start 4A
4 B – Drying 4D
4 C – Cancel
4E
4 D – Equipment ON 4B
4 E – Heating / Sterilization 4F
4 F – Drying 4G
4 G – Cycle end 4C

6
GENERAL DATA
Caracteristics and operation 17B
Steam internal outlets
They’re holes in the rear wall of the internal
chamber (17), they take the steam to the pressure
control valve.
17
Note: In the lower hole there’s a protective
filter (17A), it prevents solid residues from
entering the steam outlet. 17A

External steam outlet

The 5/16” hose fitting, found in the autoclave
rear part, takes the steam outside.

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

Trays and support 16

The support (18) and the two trays (16)
keep the materials to be sterilized apart from the
chamber’s side walls, from the bottom and from
the water.
18
WARNING:
The material to be sterilized can’t be in contact
with any of the internal walls of the chamber.

Graduated glass
It’s used to dose the quantity of distilled water
needed for each sterilization cycle.

Tray holder
It’s a device used to handle trays, avoiding
direct contact with the operator.

7
GENERAL DATA

15
16
14
13

28A
01 28B
12
02 11
26 10

03
09
07
04
08

05

06

01 - Autoclave’s body 10 - Steam outlet hose

02 - Front door 11 - Hose’s fixing clamp
03 - Manometer 12 - Steam external outlet
04 - Control panel 13 - Anti-vacuum valve
05 - Door latch 14 - Sealing ring
06 - Plug 15 - Safety seal
07 - Cord 16 - Trays
26 - Main switch
08 - Voltage inverter switch
28A – Stainless steel sterilization chamber
09 - Fuse holder 28B – Aluminum sterilization chamber (optional)

8
TECHNICAL SPECIFICATIONS
• Tension of Feeding • Volume • Degree of protection
+20% 12 Liters Tipo BF
127V~ -20% • Protection fuses

+20% F1 = 0,5A • Water leak protection
220V~ -10% F2 and F3 = 15A IPX0
F4 = 08A
• Frequency
50/60Hz • Complete cycle
• Diameter of the chamber
60 minutes
214 mm
• Power These values are approximate,
1600VA they may change depending on
• Chamber’s depth
the material’s type and volume,
318 mm
energy oscillation, etc.
• Sterilization pressure
1,7 kgf/cm2 ± 0,4 (1,3 to 2,1kgf/cm2) • Water consumption • Manometer’s tolerance
150 - 200ml variation
• Operation temperature Divide the manometer’s scale
128ºC ±5 (123 to 133ºC) • Net Weight by three equal parts. For the
23 Kg first part, the tolerance is 3%,
• Sterilization time for the second part is 2%, and
16 minutos • Gross Weight for the third is 3%.
26 Kg

Standards
This equipment was designed, manufactured and tested in compliance with the following standards:
NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança;
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); IEC 61000-4-2 (1999);
Amendment 2 EN 60601-1 (1995); IEC 61000-4-3 (1998);
Amendment13 EN 60601-1 (1995); IEC 61000-4-4 (1995);
EN 60601-1-2 (2001); IEC 61000-4-5 (1995);
NBR IEC 601-1 (1994); IEC 61000-4-6 (1996);
Emenda 1 NBR IEC 601-1 (1994); IEC 61000-4-11 (1996);
CISPR 11, edição 3.1 (ago/1999);

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 that the electricity network is compatible with the equipment’s specification.
- Before turning your autoclave on, install the fuses included with the equipment.
- Check if the grounding conductor is correctly connected.
- Never use cord extensions, connectors or voltage transformers.

NOTE: This information are also contained in the Installation and maintenance manual owned by
the GNATUS authorized technician.

9
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.

Packing symbols
Packing to be transported and / or Packing to be transported and / or
stored with care (should not suffer drop stored with care.
and neither receive impact).

Packing to be transported and / or The packing must be stored and

stored with the harrows up. transported away from direct sun
light exposure.

Maximum stacking determines the Temperature limit for the packing

maximum number of boxes which can to be stored or transported.
04 be stacked during the transportation
and storage.

Product symbols
Indicates that the device is on Indicates drying

Indicates that the device is Indicates cycle start

in heating mode

Indicates that the device is Indicates cycle end

in sterilization mode

Indicates cycle cancellation Warning – See manual

10
TECHNICAL SPECIFICATIONS

Dimensions (mm)

11
TECHNICAL SPECIFICATIONS

Contents of the marks accessible and not accessible

12
TECHNICAL SPECIFICATIONS
Contents of the marks accessible and not accessible (Legends)
01 - Product’s identification label
02 - Attention: Hot surface
03 - Fuse 15A (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 08A (F4)
07 - Before first use, please remove the protector film, which wraps this tray.
08 - Fuse 0,5A (F1)
09 - Maximum power per resistance: 800W - Warning: 2 Resistances
10 - Before begin the cycle, provision with 200 ml of distilled water

INSTALLATION
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 (08) 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. 08

Installing or replacing fuses

NOTE:
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 19
position indicated.
ATTENTION: Before installing or replacing fuses,
unplug the electric power cord.
NOTE: Fuses that come with the Autoclave:
- 2 15A fuses installed in the equipment (F2/F3) +
09
1 spare;
- 1 08A fuse installed in the equipment (F4) + 1 spare;
- 1 0.5A fuse installed in the equipment (F1) + 1 spare.
ATTENTION:
- 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.

13
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 12
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 11
and steam flow, keep the hose straight, avoiding
the formation of bends and siphons.
10

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 20
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.
16

WARNING:
Before first use, please remove the protector
film, which wraps this 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 27
operator’s safety and for the equipment’s warranty.
For this reason, the middle pin (ground) can’t be
removed or cut.

14
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.

IMPORTANT: Don’t use “Kraft / TNT” paper

for wrapping the materials to be sterilized (types
of wrappings for autoclave sterilization)
* 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.

WARNING: 21
The material to be sterilized (22) can’t be
in contact with any of the internal walls of the 22
chamber.

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)

WARNING:
22
In order to avoid accidents and burns, it’s very
important that the door is well closed.

23

15
OPERATION
How to use the autoclave (Control panel)
Press the cycle start key (4A), the
autoclave will automatically start to heat, and 24
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.
A f t er th e he atin g ha s r eac hed 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.
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 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 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.
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

16
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 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
Gnatus authorized technician.
13
WARNING
HIGH TEMPERATURE. Before carrying
out the procedure described above, wait until
it’s cold.

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 can’t be in contact with most chemical substances used in dentistry treatments,
i.e. acids, mercury, acrylic liquids, amalgams, etc.
- Don’t touch the autoclave’s internal surfaces when it’s in drying mode.
- Before turning your autoclave on, install the fuses included with the equipment.
To clean the equipment, we recommend the use of “BactSpray (Reg nº MS:
3.2079.0041.001-5) or any other similar product:
Active component: Benzalkonium chloride (tri-quaternary ammonium)
Solution 50%................................................. 0.329%
Chemical composition: Butyl Glycol, Decyl polyglucose, Sodium Benzoate, Sodium
Nitrate, Essence, Deodorized Propane / Butane, demineralized Water.
For more information concerning cleaning procedures, see manufacturer’s instructions.
WARNING:
• In order to prevent risks and damages to equipment, make sure that the liquid does
not enter into the unit.
• The application of other solvent-based cleaning products or sodium hypochloride isn’t
recommended, because they may damage the equipment.
NOTE: The registration at the Ministry of Health of “BactSpray” is performed separately
from the product described in this manual, as the “BactSpray” is not manufactured by
Gnatus.

17
MAINTENANCE
Internal cleaning (chamber and stainless steel trays sterilization)
NOTE: Changing in visual appearance inner the autoclave tank is a normal feature of the product
due to the heating of it.
Spots and oxidations signs may occur due to the continuous use and it is totally or partially removed
according to the recommended procedure as below:
In order to execute the internal cleaning of your equipment, sterilization chamber and trays,we
recommend using the product “SDS - 1000”. Product notified at ANVISA/MS.
Follow manufacturer’s directions for cleaning.
Product’s composition: inorganic-acids, fluoride and anionic tense-active based products.
WARNING: After the cleaning procedure perform a complete cycle of autoclaving and then eliminate
the water of the reservoir and dry the tub using a clean cloth.
NOTE: The registration at the Ministry of Health of “SDS - 1000” is performed separately from the
product described in this manual, as the “SDS - 1000” is not manufactured by Gnatus.
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).

NOTE: The registration at the Ministry of Health of “HIGINDOOR 207” is performed separately from
the product described in this manual, as the “IHIGINDOOR 207” is not manufactured by Gnatus.

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.
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.
Cleaning the filter
- The autoclave’s 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.
- Don’t use sharp objects, which could damage the fabric.
Wrapping types for sterilization by autoclave
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;
- don’t 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.

18
MAINTENANCE

GNATUS FORBID:
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.
• Observe each country’s standards related to wrapping preparation.

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.
A - Place the piece diagonally and in the middle of the wrapping
material;
B - Hold the “a” corner, fold it and cover the piece;
C - Hold the “b” corner and fold it over the piece, covering it and
bending the end upwards;
D - Repeat the last step with the “d” corner;
E - Fold the “c” corner in the direction of the operator;
F - Take the “c” corner and insert them under the folds made in C,
D and E;
G - Let the “c” corner outside, in order to prevent the sterilized material
from being contaminated and making the wrapping opening easier;
H - If necessary, seal the wrapping using cord or crepe.
* Observe each country’s norms related to wrapping techniques
application.

19
CONTROL OF THE STERILIZATION PROCESS

Control of the pressurized and saturated steam sterilization

process
The Autoclave BIOCLAVE 12L is tested in the plant to check the capacity of sterilization, using for
this purpose the Biological Indicator (BI) model “ATTEST” of the manufacturer “3M” (Ministry of Health
Reg.: 10002070068) in order to attend to the requirements of ANVISA (National Agency of Sanitary
Surveillance) in Brazil and of international organizations such as AAMI (Association for the Advancement
of Medical Instrumentation) and CDC (Centers for Disease Control and Prevention).
Composition of the product: Plastic bottle containing a glass ampoule with nutrient broth and a strip
of paper impregnated with suspension of dry spores of Bacillus stearothermophilus - ATCC 7953.
NOTE: The registration at the Ministry of Health of this product is performed separately from the
Autoclave 12L, as the product “ATTEST” is not manufactured by Gnatus.
The BI test consists of an ampoule that contains and strip impregnated with 10 Geobacilus
sthearothermophillus spores. These organisms are particularly resistant to the steam sterilization
process.
All BIOCLAVE 12L autoclaves are tested at the production line following a procedure that ensures
the equipment’s efficiency to provide safe and sterilized articles.

Maintenance of the qualification

In order to maintain the quality and the sterilization efficiency during the equipment’s 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.

Testing procedure using biological indicators

1) Make a test package that allows the steam to penetrate into it, place a BI inside it, and place
the test package in the coldest part of the autoclave (in this case, the coldest part of the BIOCLAVE is
the upper part, near the door), with the load for a routine cycle.
2) Identify the test package that contains the BI, remember that this package shall be opened to
remove the BI.
3) Once the cycle is finished, wait until the package is cold, then open it and remove the BI; break
the BI ampoule inside the specified incubator and incubate it for 48 hours.
4) At the same time, place a BI ampoule (one that hasn’t passed through the sterilization process)
into the incubator, in order to verify the incubator operation and also to control the viability of the spores
used in the test; check the BIs (both the positive control and the test ampoule), follow the directions
provided by the manufacturer.
5) Record test data and its results in a record system
6) If the BI test’s results were positive, don’t use the equipment until it has been checked and
repaired by the authorized technical service.

Attest biological monitoring system for steam sterilization

process
For more information about biological and chemical control, access www.3M.com/br/hospitalar

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TROUBLESHOOTING
Imprevisto
Problem: Probable Cause: Solution:
- The autoclave doesn’t swi- - The cord is disconnected - Connect the cord to the so-
tch on cket
- Power cut - Wait until energy is back
- Burnt fuse(s) - Replace fuse(s)
- Bad contact in the socket - Replace socket

- The ON/OFF switch is OFF. - Turn the ON/OFF button ON.

- The autoclave can’t reach or
maintain the pressure high
- The voltage supplied is lower
than the one required by the
autoclave
- Leakage in the safety
seal remove the safety seal and the
- The door latch isn’t in position,
causing leakage
- An electrician must check and
adapt the electricity supply
- Disconnect the autoclave, and
anti-vacuum valve, clean them
and place them again. If it were
necessary, replace them.
- Place the door latch pushing it
downwards

- Not enough water -Check that the volume of water

is the specified

- Overloaded chamber - Use up to 70% of the chamber,

leaving spaces between the
packages

-The autoclave’s door can’t be -The autoclave isn’t yet depres- -Wait the autoclave depressu-
opened surized rization

* In case of continous fails, request to the attendance section to the customer a

authorized technician Gnatus.

ATTENTION:
Any other problem that could happen with its equipment, should only be repaired by an Authorized
Technician GNATUS.
The bad use, negligence or maintenance not made by technician authorized by the maker, will imply
in the loss of the warranty.

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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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