2

INDEX

Product Description ............................................................................................................... 03Warranty of the Equipment ................................................................................................... 04Important Safety Considerations .......................................................................................... 04General Data ......................................................................................................................... 04Technical Specifications ....................................................................................................... 08Symbols ................................................................................................................................. 09Dimensions ............................................................................................................................10Installation .............................................................................................................................. 12Operation ............................................................................................................................... 14Maintenance .......................................................................................................................... 16Precautions ........................................................................................................................... 16Cleaning ................................................................................................................................. 16Control of the sterilization process ...................................................................................... 19Troubleshooting .................................................................................................................... 20Final Considerations .............................................................................................................. 20

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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 presentationof 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 dentistryoffices (general practice, endodontia, pediatric dentistry, orthodontics, prosthesis, operative dentistryand esthetics).

Its structure is made of carbon steel, with high-shine epoxi paint, polymerized at 250ºC, withphosphate treatment resistant to corrosion and cleaning materials.

The chamber is made of stainless steel, offering durability and resistance to permanent temperaturechanges, and has a capacity of 12 liters.

It’s internally coated with heath isolating material, which optimizes its operation and reduces theenergy consumption.

It features an anti-vacuum valve, which prevents the door and safety seal from blocking, and it’sautomatically activated if an excessive pressure was detected. The door’s sealing system is made ofhigh-performance silicone, resistant to temperature and pressure changes, and its flexibility allows theperfect sealing between surfaces in contact, preventing leakage.

The control panel contains LED and function buttons, graduated manometer for temperature andpressure, ergonomic handle with automatic depressurization safety system, which prevents accidentsin case of unintentional opening.

It comes with a hose for steam outlet, graduated glass, fuses for 127/220V~ and two perforatedstainless-steel trays, which allow the heat diffusion, thus ensuring the quality of the sterilizationprocess.

Note: Give preference to hand pieces and peripherals developed in accordance with requirementsof directive 93/42/EEC (with CE mark).

Quality Management System certificate in accordance to ISO 9001:2000 and ISO 13485:2003standart, assuring that equipments are produced in base with standardized procedures, meeting thequality continually improve.

Products manufactured in agreement with RDC 59 - ANVISA - (Sanitary Surveillance NationalAgency) - 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 lifeof metallic structure this product is estimated in 10 years (life-cycle) provided that the end-userfollows 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 theinstructions of the manual. The operation of the equipment required, for the professional, the utilizationof correct instruments and it should to be in perfect conditions of the use, and to protect theprofessional, the patients and others, in the eventual danger situation.

• This equipment can’t be used in the presence of inflammable anesthetics or products that maycause 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

4

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 holdresponsible 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 procedurewere 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 (page 6).

- 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 theinternal steam outlet blockage or by an obstruction in the pressure control valve, wait until the completedepressurization 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 incontact 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 standardsspecified on the Warranty Certificate. The Warranty Certificate is attached to product, and must becompleted 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 agreementbetween the user and Gnatus Company.

Protection against current overloadThe equipment is protected from current overload by three fuses.- For 127V~: 3 fuses, 2 of 15A, 1 of 0,5A;- For 220V~: 3 fuses, 2 of 08A, 1 of 0,5A.

NOTE: : To install the fuses, see page 12.

GENERAL DATA

5

Válvula anti-vacío

Sello de seguridad

4D

4F4E

4G

4A

4B

4C

GENERAL DATA

Caracteristics and operation

ManometerIt’s used for temperature and pressure

control, and its graduation range from 0 kgf/cm²to 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%, forthe 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 internalpressure in casa of overpressure.

If the sealing ring were moved from its place,call a Gnatus authorized technician to carry outthe 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 itexceeds. The anti-vacuum valve has the samefunction, and it also reduces the pressure of thechamber if it were negative (vacuum).

NOTE:If during the sterilization procedure the valves

were opened, the operator can reset them (page16). However, the appropriate cooling time mustbe observed in order to prevent accidents.

If the valves were opened repeatedly, call aGnatus authorized technician.

NOTE: Execute the replacement of thesafety seal and anti-vacuum valve within theperiod “of 36 months”. If it is necessary todo it before the period indicated, requestthe presence of an authorized Gnatustechnician.

Control panelFound in the front part of the autoclave, it

contains all controls necessary to operate theequipment.

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

6

17

17A

11

17B

16

18

GENERAL DATACaracteristics and operationSteam internal outlets

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

Note: In the lower hole there’s a protectivefilter (17A), it prevents solid residues fromentering 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 thechamber’s side walls, from the bottom and fromthe 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.

7

05

15

1314

16

01

02

03

04

26

09

0708

06

1211

10

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 switch

GENERAL DATA

8

TECHNICAL SPECIFICATIONS

StandardsThis 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. If it’s not

compatible, change the voltage selection key and replace the fuses (see page 12).- Before turning your autoclave on, install the fuses included with the equipment (see page 12).- 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 theGNATUS authorized technician.

• Tension of Feeding127V~

220V~

• Frequency50/60Hz

• Power1600VA

• Sterilization pressure1,7 kgf/cm2 ± 0,4 (1,3 to 2,1kgf/cm2)

• Operation temperature128ºC ±5 (123 to 133ºC)

• Sterilization time16 minutos

• Volume12 Liters

• Protection fusesF1 - 127 / 220V~ = 0,5AF2 and F3 - 127V~ = 15AF2 and F3 - 220V~ = 08A

• Diameter of the chamber214 mm

• Chamber’s depth318 mm

• Water consumption150 - 200ml

• Net Weight23 Kg

• Gross Weight26 Kg

• Degree of protectionTipo BF

• Water leak protectionIPX0

• Complete cycle60 minutesThese values are approximate,they may change depending onthe material’s type and volume,energy oscillation, etc.

• Manometer’s tolerancevariationDivide the manometer’s scaleby three equal parts. For thefirst part, the tolerance is 3%,for the second part is 2%, andfor the third is 3%.

+20% -20% +20% -10%

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0404

TECHNICAL SPECIFICATIONSTransport 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

Packing to be stored with a maximumstack of 04 units.

Temperature limit for the packingto be stored or transported.

Packing to be transported and / orstored with care (should not sufferdrop and neither receive impact).

Packing to be transported and / orstored with care.

Indicates cycle end

Indicates that the device is on

Indicates that the device isin heating mode

Indicates that the device isin sterilization mode

Indicates drying

Indicates cycle start

Warning – See manualIndicates cycle cancellation

The packing must be stored andtransported away from direct sunlight exposure.

Packing to be transported and / orstored with the harrows up.

Product symbols

10

TECHNICAL SPECIFICATIONS

Dimensions (mm)

11

Contents of the marks accessible and not accessible

TECHNICAL SPECIFICATIONS

12

09

19

08

TECHNICAL SPECIFICATIONS

01 - Product’s identification label02 - Attention: Hot surface03 - 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 invertthe 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

Contents of the marks accessible and not accessible (Legends)

INSTALLATIONPreparing the autoclave (Steps previous to operation)

Installing or replacing fusesNOTE:For reasons of safety, the F2/F3 fuses are not

installed in factory. Therefore, these fuses must beinstalled before turning the equipment on. Using ascrewdriver, loosen the fuse holder’s cap (09), andplace the fuses (19) in specified position. To replacethe 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 futurereplacements.

Voltage changeFor your safety, the autoclave is factory-set to

220V. For this reason, you must check the suitabilityof the electricity supply. If the electricity networkavailable is 127V, change the voltage switch.

Change the voltage switch (08) according to thelocal 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.

13

16

27

11

20

06

10

12

WARNING:The ground connection is very important to

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

INSTALLATION

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

In order to prevent the obstruction of waterand 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 meltingwhen in contact with steam, which may causethe 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 upperpart.

WARNING:Before first use, please remove the

protector film, which wraps this stell tray (27).

The female socket must be of the type usedfor computers, with three pins.

Check the ground connection.

Preparation

Preparing the autoclave (Steps previous to operation)

14

2122

22

23

OPERATIONHow to use de autoclave

Raise the door latch, push it to the left, andcheck 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 insidethe 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 obstructionof the internal valves and stain the instruments,and the warranty will not be applicable.

All material being sterilized must be previouslywashed, rinsed and dried.

IMPORTANT: Don’t use “kraft” paper forwrapping the materials to be sterilized.

(see page 35– types of wrappings forautoclave sterilization)

* Observe each country’s standards forpreparation of material to be sterilized.

Distribute the wrappings at equal distances(22) leaving enough space between them so asto allow the steam to circulate.

WARNING:The material to be sterilized (22) can’t be in

contact with any of the internal walls of thechamber.

Close the autoclave’s door pushing it againstthe tank, pushing the door latch to the right andthen 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.

15

24

25

OPERATIONHow to use the autoclave (Control panel)

Press the cycle start key (4A), theautoclave will automatically start to heat, andyou will hear 2 beeps, and a green LED (V)will come on. The heating time depends onthe quantity of the material to be sterilized.

After the heating has reached atemperature of 128ºC ±2, the autoclave willenter in the pressure sterilization mode, witha pressure from 1,7± 0,4 kgf/cm² (24), theLED (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 theautoclave will be depressurized. After threeminutes you will hear ten beeps. The blueLED (4F) will come on, indicating the dryingmode. In this moment, the door shall be openedand it must remain ajar (25) so as to dry thesterilized material.

IMPORTANT:If it was necessary to stop the

sterilization cycle, press the cycle interruptionkey (4C). Wait until the autoclave is completelydepressurized 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 ofthe autoclave, so as to prevent accidentsand burns. The drying cycle lasts half anhour. Finally, the autoclave will emit threebeeps, 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, indicatingthe start of a new drying cycle that will last30 minutes. If the operator notes that thematerial is already dry, he can cancel thecycle 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 remainblinking, activating the discharge valve for 3minutes. During this time, no function will beavailable. When the power were restored,check the water level, if necessary, replenishthe specified quantity and start the cycleagain.

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13

MAINTENANCERecommendations for the dental equipment maintenance

Your Gnatus equipment has been designed and developed according to the standards of moderntechology. Similarly to other kinds of equipment, it requires special care, which is many times neglecteddue to several reasons and circunstances.

Therefore, here are some important reminders for your daily routine. Try to follow these simplerules, which will save you a lot of time and will avoid unnecessary expenses once they start makingpart 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.If the voltage were changed, these fuses may be changed.

OPERATIONResetting the valves (safety seal and anti-vacuum valve)

If the valve (13) were opened during thesterilization process, the operator can reset it.Open the autoclave’s front door and wait untilit’s cold. Proceed as described in the drawing,pressing them until they go back to their originalposition.

If the valves were opened repeatedly, calla Gnatus authorized technician.

WARNINGHIGH TEMPERATURE. Before carrying out

the procedure described above, wait until it’scold.

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, SodiumNitrate, Essence, Deodorized Propane / Butane, demineralized Water.

For more information concerning cleaning procedures, see manufacturer’sinstructions.

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.

17

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” nº Reg. MS: 3.02053-1.Follow manufacturer’s directions for cleaning.Product’s 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 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: 3.02053-1.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 solutionusing a clean piece of cloth moistened with water.

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 stateof the instruments. It also has chemical indicators of the process.

GNATUS prohibit the use of “kraft” paper for wrappingmaterials to be sterilized, because it isn’t manufactured with thispurpose. Its use has many disadvantages when compared toother materials, such as irregularities and uneven texture, whataffects the resistance, turning it inadequate for its use as microbialbarrier. Besides, it frequently contains starch, colorings and othertoxic products that can stain the parts. It can also containAlkylthiophene, which, during the sterilization process may giveoff an unpleasant smell, which causes nausea and headache ifbreathed.

18

MAINTENANCE

Suggested method for wrapping instruments and materialsThe 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 wrappingmaterial;

B - Hold the “a” corner, fold it and cover the piece;

C - Hold the “b” corner and fold it over the piece, covering it andbending 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 in3, 4 and 5;

G - Let the “c” corner outside, in order to prevent the sterilizedmaterial from being contaminated and making the wrapping openingeasier;

H - If necessary, seal the wrapping using cord or crepe.

· Observe each country’s norms related to wrappingtechniques application.

And besides all these disadvantages, during the sterilization process, this kind of paper releasespieces of fiber that can clog the autoclave’s valves and piping system.

· Observe each country’s standards related to wrapping preparation.

19

Control of the pressurized and saturated steam sterilization processThe BIOCLAVE 12L autoclave is tested in the factory in order to verify its sterilization capability. It’s

used an ATTEST Biological Indicator (BI), in order to comply with requirements from ANVISA (SanitaryAdministration National Agency) in Brazil, and from international organizations, such as AAMI (Associationfor the Advancement of Medical Instrumentation) and CDC (Centers for Disease Control and Prevention)

The BI test consists of an ampoule that contains and strip impregnated with 105 Geobacilussthearothermophillus spores. These organisms are particularly resistant to the steam sterilizationprocess.

All BIOCLAVE 12L autoclaves are tested at the production line following a procedure that ensuresthe 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 isinstalled, it must be used the ATTEST control system, which consists of BI test ampoules and anincubator, which allows the incubation of the test ampoule and the verification of the final result, 48hours 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 theupper 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 toremove the BI.

3) Once the cycle is finished, wait until the package is cold, then open it and remove the BI; breakthe 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 sporesused in the test; check the BIs (both the positive control and the test ampoule), follow the directionsprovided 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 processFor more information about biological and chemical control, access www.3M.com/br/hospitalar

CONTROL OF THE STERILIZATION PROCESS

20

TROUBLESHOOTING

ImprevistoProblem: Probable Cause: Solution:

- The autoclave can’t reach ormaintain the pressure high

- The voltage supplied is lowerthan the one required by theautoclave

- An electrician must check andadapt the electricity supply

- Leakage in the safety seal - Disconnect the autoclave, andremove the safety seal and theanti-vacuum valve, clean themand place them again. If it werenecessary, replace them.

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

- Place the door latch pushing itdownwards

- Not enough water -Check that the volume of wateris the specified

- Overloaded chamber - Use up to 70% of the chamber,leaving spaces between thepackages

- The autoc lave doesn’ tswitch on

- The cord is disconnected - Connect the cord to the socket

- 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 beopened

-The autoclave isn’t yetdepressurized

-Wait the autoclavedepressurization

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 aauthorized technician Gnatus.

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 whohave 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

21

22

23