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INDEX

02 PRESENTATION OF MANUAL

04 IDENTIFICATION OF EQUIPMENT

04 Indication of Equipment

04 Purpose of the equipment

05 Description of Equipment

06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

09 TECHNICAL SPECIFICATIONS

09 General features

11 Dimensions

12 Packing symbols

12 Product symbols

13 INSTALLATION OF EQUIPMENT

17 EQUIPMENT OPERATION

20 PRECAUTIONS, RESTRICTIONS AND WARNINGS

20 Recommendations for preserving the equipment

20 Transportation, storage and operation

20 Sensitivity to predictable environmental conditions in ordinary situations of use

20 Precaution and warnings “during the installation” of the equipment

21 Precautions and warnings “during the use” of equipment

22 Precautions and warnings “after” the use of equipment

22 Precautions and warnings during the “cleaning and disinfection” of equipment

22 Precautions in case of alteration in the functioning of equipment

22 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation

and abandoning of equipment

23 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

23 Additional procedures for reuse

23 Cleaning

23 Disinfection

24 Internal cleaning (chamber and stainless steel trays sterilization)

24 Internal cleaning (aluminum sterilization chamber)

24 Piping cleaning

24 Cleaning the filter

25 Wrapping types for sterilization by autoclave

25 Suggested method for wrapping instruments and materials

26 Control of the pressurized and saturated steam sterilization process

26 Maintenance of the qualification

26 Testing procedure using biological indicators

26 Attest biological monitoring system for steam sterilization process

26 Preventive Maintenance

26 Corrective Maintenance

27 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS

27 EQUIPMENT’S WARRANTY

27 FINAL CONSIDERATIONS

Summary of Contents for Autoclave Bioclave 21L

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Page 2: ...t 582 002 897 114 Rod Abrão Assed Km 53 450m Cx Postal 782 CEP 14097 500 Ribeirão Preto S P Brasil Phone 55 16 3512 1212 Technical Duties Ricardo J Ravaneli CREA SP 5060714523 Registration ANVISA nº 10069210079 For improved safety Read and understand all the instructions contained in the Instructions for Use before installation or operation of this equipment Note The Instructions for Use must be r...

Page 3: ... cleaning and disinfection of equipment 22 Precautions in case of alteration in the functioning of equipment 22 Precautions to be adopted against foreseeable or uncommon risks related to the deactivation and abandoning of equipment 23 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION 23 Additional procedures for reuse 23 Cleaning 23 Disinfection 24 Internal cleaning chamber and stainless stee...

Page 4: ...tion 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 IDENTIFICATION OF PRODUCT Purpose of the equipment Sterilization by autoclave has the purpose...

Page 5: ...r 21 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...

Page 6: ...l compatibilty between equipment coupling and accessories 01 Autoclave s body 02 Front door 03 Manometer 04 Control panel 05 Door latch 06 Plug input power cable 07 Voltage selector switch 08 Fuse holder 09 Master key 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 17 Sterilization chamber available in stainless stee...

Page 7: ... hose This accessory must be connected and fixed to the external steam outlet using a clamp It takes steam out 03 Graduated glass It s used to dose the quantity of distilled water needed for each sterilization cycle 04 Trays and support Support with 3 trays to keep materials to be sterilized from contact with chamber bottom and water sidewalls WARNING The material to be sterilized can t be in cont...

Page 8: ...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 Execut...

Page 9: ... from entering the steam outlet External steam outlet The 5 16 hose fitting found in the autoclave rear part takes the steam outside Model Autoclave 21L Power Supply Voltage 127V 100 140V 220V 198 264V Frequency 50 60 Hz Power 1700W Electric shock protection type Class one equipment Applied Part Type B Mode of Operation Continuous operation TECHNICAL SPECIFICATIONS General features MODULES ACCESSO...

Page 10: ... 30 Kg 33 Kg Fuse of Protection F1 0 5A F2 and F3 20A F4 10A Full cycle time 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 Warning Pay attention while usin...

Page 11: ...11 TECHNICAL SPECIFICATIONS Dimensions mm For installation of the Autoclave in niches cabinets consider the addition of 50mm in the total length of the product ...

Page 12: ...direct sun light exposure Packing to be transported and or stored with care should not suffer drop and neither receive impact Temperature limit for the packing to be stored or transported Applied part type B Grounding at several points of the equipment indicates the condition of being grounded General warning If the instructions are not properly followed the use can lead to damage to the product u...

Page 13: ...llation and Maintenance Manual of the equipment that is found with the Gnatus authorized technical representative Important safety considerations Never touch the steam external outlet 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 ...

Page 14: ...otected from current overload by fuses 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 if the grounding conductor is correctly connected Never use cord extensions connectors or voltage transformers It is necessary to use a socket higher than...

Page 15: ...nt it is advisable to always have spare fuses at hand All fuses must be installed independently from the grid voltage Preparing the autoclave 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 obstructi...

Page 16: ...efore first use please remove the protector film which wraps this tray 27 The female outlet should be a grounded bipolar type three prong 2 flat and 1 round Verify that the ground wire is properly connected ATTENTION 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 OF EQUIPME...

Page 17: ...lave 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 In order to avoid accidents and burns it s very important that the door is well closed 6 Green led 4D in the front panel will come on indicating that the autoclave is on WARNING Don t use Kraft TNT paper for wrapping the materials to besterilized types of wrappings ...

Page 18: ...ly depressurized before opening the door 10 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 WARNING 11...

Page 19: ... 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 until it s cold OPERATION OF EQUIPMENT ...

Page 20: ...5 Atmospheric pressure range 700 hPa to 1060 hPa 525 mmHg to 795 mmHg Operation altitude 2000m Attention The Equipment maintains its condition of safety and efficacy provided that it is maintained stored as mentioned in this instruction of use Thus the equipment will not lose or alter its physical and dimensional features Sensibility to predictable environmental conditions in regular use condition...

Page 21: ...he equipment which could cause short circuits Never touch the steam external outlet 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 ...

Page 22: ... of equipment Turn off the main switch of the dental set when it is not in use for an extended period of time Always maintain the equipment clean for the next operation Do not modify any part of the equipment Do not disconnect the cable or other connections without need Precautions and warnings during the cleaning and disinfection of equipment Before cleaning the equipment turn off the main switch...

Page 23: ...ipment make sure that the liquid does not enter into the equipment To cleaning the equipment using the damp cloth with a mild soap The application of other solvent based cleaning products or sodium hypochloride isn t recommended because they may damage the equipment Disinfection Use clean and soft cloth dampened in alcohol 70 to disinfection of the equipment Never use corrosive disinfectants or so...

Page 24: ... 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 HIGINDOOR 207 is not manufactured by Gnatus Piping cleaning Monthly the internal components of the autocla...

Page 25: ...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 th...

Page 26: ...d 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 ...

Page 27: ...es The autoclave s door can t be opened The autoclave isn t yet de pressurized Wait the autoclave depres surization Upon coming across any problem in operation follow the instructions below to check and repair the problem and or get in touch with your representative UNFORESEEN EVENTS SOLUTION OF PROBLEMS FINAL CONSIDERATIONS Among the care you have to take with your equipment the most important is...

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