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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 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.

GENERAL DATA

Summary of Contents for Autoclave Bioclave 12L

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Page 2: ...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 Equipme...

Page 3: ...fety 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 ...

Page 4: ... 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 im...

Page 5: ...essurization 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...

Page 6: ...e Placed 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 ...

Page 7: ...upport 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 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 External steam outlet s hose This accessory ...

Page 8: ...tch 09 Fuse holder 10 Steam outlet hose 11 Hose s fixing clamp 12 Steam external outlet 13 Anti vacuum valve 14 Sealing ring 15 Safety seal 16 Trays 26 Main switch 28A Stainless steel sterilization chamber 28B Aluminum sterilization chamber optional GENERAL DATA 05 15 13 14 16 01 02 03 04 26 09 08 06 12 11 10 28A 28B 07 ...

Page 9: ...ly 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...

Page 10: ...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 dry...

Page 11: ...11 TECHNICAL SPECIFICATIONS Dimensions mm ...

Page 12: ...12 Contents of the marks accessible and not accessible TECHNICAL SPECIFICATIONS ...

Page 13: ... 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 5Afuse installed in the equipment F1 1 spare ATTENTION A...

Page 14: ...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 pla...

Page 15: ...nty 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...

Page 16: ...e 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 indi...

Page 17: ...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 WARNING HIGH TEMPERATURE Before carrying out the procedure described above wait u...

Page 18: ... 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 manufactur...

Page 19: ... 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 unpl...

Page 20: ...t be carried out routinely To perform this test in the same place where the autoclave is installed it must be used theATTEST 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 i...

Page 21: ...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 t...

Page 22: ...pecifications 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 CONSI...

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