2

PRESENTATION OF MANUAL

INSTRUCTIONS FOR USEEQUIPMENT:

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. 582.329.957.115www.gnatus.com.br - gnatus@gnatus.com.br Technical Duties: Gilberto Henrique Canesin Nomelini CREA-SP: 0600891412

Registration ANVISA Nº: 10229030042

ATTENTIONFor 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.

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INDEX

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

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DEAR CUSTOMERCongratulations. 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.

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 destroyedin 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.

PRODUCT DESCRIPTION

5

WARRANTY OF THE 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 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.

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.

Maintenance of the equipmentThe 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 schemeGnatus 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 overloadThe equipment is protected from current overload by fuses.

GENERAL DATA

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Válvula anti-vacío

Sello de seguridad

4D

4F4E

4G

4A

4B

4C

GENERAL DATA

Caracteristics and operationManometer

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 variationDivide 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 ringBesides 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 valvePlaced in the internal part of the door, they

diminish the pressure in the chamber, in case it exceeds. The anti-vacuum valve has the same function, and it also reduces the pressure of the chamber if it were negative (vacuum).

NOTE:If during the sterilization procedure the valves

were opened, the operator can reset them. However, the appropriate cooling time must be observed in order to prevent accidents.

If the valves were opened repeatedly, call a 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 panelFound in the front part of the autoclave, it

contains all controls necessary to operate the equipment.

4 A – Cycle start4 B – Drying4 C – Cancel4 D – Equipment ON4 E – Heating / Sterilization4 F – Drying4 G – Cycle end

7

17

17A

11

17B

16

18

GENERAL DATA

Caracteristics and operationSteam internal outlets

They’re holes in the rear wall of the internal chamber (17), they take the steam to the pressure control valve.

Note: In the lower hole there’s a protective filter (17A), it prevents solid residues from entering the steam outlet.

External steam outletThe 5/16” hose fitting, found in the autoclave

rear part, takes the steam outside.

Trays and supportThe 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.

WARNING:The material to be sterilized can’t be in contact

with any of the internal walls of the chamber.

Graduated glassIt’s used to dose the quantity of distilled water

needed for each sterilization cycle.

External steam outlet’s hoseThis accessory must be connected and fixed

to the external steam outlet using a clamp (11). It takes steam out.

Tray holderIt’s a device used to handle trays, avoiding

direct contact with the operator.

Accessories which accompany the Autoclave

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01 - Autoclave’s body02 - Front door03 - Manometer04 - Control panel05 - Door latch06 - Plug07 - Cord08 - Voltage inverter switch09 - Fuse holder

10 - Steam outlet hose11 - Hose’s fixing clamp12 - Steam external outlet13 - Anti-vacuum valve14 - Sealing ring15 - Safety seal16 - Trays26 - Main switch28A – Stainless steel sterilization chamber28B – Aluminum sterilization chamber (optional)

GENERAL DATA

05

15

1314 16

01

02

03

04

26

09

08

06

1211

10

28A28B

07

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TECHNICAL SPECIFICATIONS

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); 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); CISPR 11, edição 3.1 (ago/1999);

IEC 61000-4-2 (1999); IEC 61000-4-3 (1998); IEC 61000-4-4 (1995); IEC 61000-4-5 (1995); IEC 61000-4-6 (1996); IEC 61000-4-11 (1996);

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.

• Tension of Feeding 127V~ 220V~

• Frequency 50/60Hz • Power 1600VA

• Sterilization pressure 1,7 kgf/cm2 ± 0,4 (1,3 to 2,1kgf/cm2)

• Operation temperature 128ºC ±5 (123 to 133ºC)

• Sterilization time 16 minutos

• Volume 12 Liters• Protection fuses F1 = 0,5A F2 and F3 = 15A F4 = 08A • Diameter of the chamber 214 mm

• Chamber’s 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 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%.

+20% -20%

+20% -10%

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04

TECHNICAL SPECIFICATIONS

Transport and storage conditionsThe 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

Maximum stacking determines the maximum number of boxes which can be stacked during the transportation and storage.

Temperature limit for the packing to be stored or transported.

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

Packing to be transported and / or stored with care.

Indicates cycle end

Indicates that the device is on

Indicates that the device is in heating mode

Indicates that the device is in sterilization mode

Indicates drying

Indicates cycle start

Warning – See manualIndicates cycle cancellation

The packing must be stored and transported away from direct sun light exposure.

Packing to be transported and / or stored with the harrows up.

Product symbols

11

TECHNICAL SPECIFICATIONS

Dimensions (mm)

12

Contents of the marks accessible and not accessible

TECHNICAL SPECIFICATIONS

13

09

19

TECHNICAL SPECIFICATIONS

01 - Product’s identification label02 - Attention: Hot surface03 - 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 Resistances10 - Before begin the cycle, provision with 200 ml of distilled water

Contents of the marks accessible and not accessible (Legends)

INSTALLATION

Preparing the autoclave (Steps previous to operation)

Installing or replacing fusesNOTE: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.

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) + 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 fromthe grid voltage.

Voltage changeFor 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

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16

27WARNING:The ground connection is very important to the

operator’s safety and for the equipment’s warranty. For this reason, the middle pin (ground) can’t be removed or cut.

INSTALLATION

Connect and fix the rubber hose (10) using the clamp (11) to the external steam outlet (12) found in the autoclave’s rear part. The other end must be placed in a water container (20) or in a drainage which can stand high temperatures.

In order to prevent the obstruction of water and steam flow, keep the hose straight, avoiding the formation of bends and siphons.

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.

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.

PreparationPreparing the autoclave (Steps previous to operation)

11

20

10

12

15

2122

22

23

OPERATION

How to use de autoclaveRaise 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 – 150mlAutoclave 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:The material to be sterilized (22) can’t be

in contact with any of the internal walls of the 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:In order to avoid accidents and burns, it’s very

important that the door is well closed.

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24

25

OPERATIONHow 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 heat ing 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.

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.

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13

MAINTENANCE

Recommendations for the dental equipment maintenanceYour 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.

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.

WARNINGHIGH TEMPERATURE. Before carrying

out the procedure described above, wait until it’s cold.

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.

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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 cleaningMonthly 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: 317130011Follow 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 autoclaveThe 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.

MAINTENANCE

19

MAINTENANCE

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.

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.•Observeeachcountry’sstandardsrelatedtowrappingpreparation.

20

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 qualificationIn 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 indicators1) 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 system6) 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

CONTROL OF THE STERILIZATION PROCESS

21

TROUBLESHOOTING

ImprevistoProblem: Probable Cause: Solution:

- The autoclave can’t reach or maintain the pressure high

- The voltage supplied is lower than the one required by the autoclave

- An electrician must check and adapt the electricity supply

- Leakage in the safety seal

- Disconnect the autoclave, and remove the safety seal and the anti-vacuum valve, clean them and place them again. If it were necessary, replace them.

- The door latch isn’t in position, causing leakage

- 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 doesn’t swi-tch on

- The cord is disconnected

- Connect the cord to the so-cket

- Power cut - Wait until energy is back

- Bad contact in the socket

- The ON/OFF switch is OFF.

- Replace fuse(s) - Burnt fuse(s)

- Replace socket

- Turn the ON/OFF button ON.

-The autoclave’s door can’t be opened

-The autoclave isn’t yet depres-surized

-Wait the autoclave depressu-rization

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.

* In case of continous fails, request to the attendance section to the customer a authorized technician Gnatus.

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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.

FINAL CONSIDERATIONS

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