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BRAVO G4 ™ Chamber Autoclave Operator’s Manual SD-601 EU ML R1 | 97055159 Rev. 2 BRAVO is a trademark of SciCan Ltd. A Coltene Group company.
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Distributed by : SciCan Ltd. A Coltene Group Company 1440 Don Mills Rd., Toronto, ON, Canada, M3B 3P9 T +1-416-445-1600 TF +1-800-667-7733 customerservice@scican.com Manufactured by: CEFLA s.c. Headquarter: Via Selice Provinciale 23/A 40026 Imola (BO) IT...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 FOREWORD The instructions inform the user on how to properly operate the device. It is extremely important to read this manual carefully and thoroughly before using the device. This publication must not be reproduced, copied or transferred in any manner (electronically, mechanically, via photocopies, translations or other means) without the prior written consent of the manufacturer.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 1.5. INTENDED USE The product described in this manual is only intended for sterilisation of reusable surgical instruments and materials. DEVICE INTENDED FOR PROFESSIONAL USE The use of the device is strictly reserved to qualified personnel. It must never be used or handled by untrained and/or unauthorised persons.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 1.7. RESIDUAL RISKS FOR THE USER • Contamination due to improper handling of the load; • Burn by contact with hot surfaces or fluids. FOR THE PATIENT • Contamination due to unsterilised material caused by wrong cleaning treatment before sterilisation;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 PACKAGE CONTENT Check the integrity of the product package upon receipt. 2.1. DIMENSION AND WEIGHT Once the package is opened, check that: • The supply matches the specifications of the order (see the delivery note);...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 2.2. DESCRIPTION OF THE CONTENT In addition to the steriliser, the package contains: Instrument trays: Helbow hose connector • 5 pcs for 17 and 22 • 6 pcs for 28;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 2.3. PRODUCT HANDLING The packed product must be handled using, where possible, suitable mechanical means (lift truck, pallet truck, etc.) and following the indications on the package. In case of manual handling, the product must be lifted by two people using the suitable available means.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 GENERAL DESCRIPTION - PRODUCT PRESENTATION 3.1. GENERAL CHARACTERISTICS The device is an electronic steam steriliser, entirely operated by a micro-processor, with a large, moulded stainless steel sterilisation chamber. It is characterised by an advanced fractionated vacuum system for the complete removal of air, even from hollow, porous materials, and an effective final vacuum drying phase capable of eliminating all traces of humidity from any load.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.2. TECHNICAL SPECIFICATIONS 3.2.1. SUMMARY TABLE STEAM STERILISER Device Bravo G4 17 Bravo G4 22 Bravo G4 28 Class (according to Directive 93/42/EEC and subsequent amendments) CEFLA s.c. Manufacturer Sede legale - Headquarter Via Selice Provinciale 23/A –...
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 STEAM STERILISER Device Bravo G4 17 Bravo G4 22 Bravo G4 28 Compliant with Standard EN 60950. Printer power supply standard: (The safety of the steriliser may be compromised in case of uncertified printer power supply unit)
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.3. SAFETY DEVICES The sterilser is equipped with the following safety devices for which we provide a brief description of their function: • Mains fuses (see data in summary table) Protection of the whole device against possible failures of heating elements.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.4. WATER SUPPLY CHARACTERISTICS Only use demineralised / distilled water having the following characteristics to supply the steriliser. DESCRIPTION VALUES IN THE WATER SUPPLY VALUES INSIDE RESIDUAL DRY CONDENSATE <...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.5. FRONT Model Control panel and LCD screen Door Power switch Dust filter Sterilisation chamber Bacteriological filter Door locking system Water drainage filter Front filling quick connector Clean water reservoir drainage quick connector...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.6. REAR Fastening slots for rear spacers Heat exchanger Connection for direct water drainage Connection for automatic demineralised / distilled water filling (only for PURE 100 / 500, H...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.7. LCD ICONS The screens in the following pictures may vary in shapes and colours, but their contents are the same as shown on the steriliser display. Selection for data management...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 3.8. EXAMPLE OF WORKING CYCLE The sterilisation program can be effectively described as a succession of phases, each one with a very precise objective. For example, the universal program (cycle B, 134°C - 4’): after loading the material in the chamber, closing the door, selecting the program and starting the cycle (after locking the door opening mechanism), the following sequence will occur (see the graph below): Generator and sterilisation chamber pre-heating;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 SETTING UP THE DEVICE The safety of every system which integrates the device is the responsibility of the system assembler. The first and essential step for a proper operation of the steriliser, its durability over time and complete use of its features, is a correct and careful commissioning.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 4.1. OVERALL DIMENSIONS Centre distance and maximum overall dimensions of the steriliser feet, with and without rear spacers. Feet Rear spacers...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 4.2. COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATION When installing the steriliser inside a cabinet, you must provide adequate space all around the device to provide effective ventilation as well as an opening in the back (D) - 180 sq.cm - that, in addition to allowing the passage of the power cord, will also provide an adequate air flow and the optimum cooling of...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 4.5. ELECTRICAL CONNECTIONS This information is shown on the back of the machine. The steriliser must be connected to a socket of the electric system having adequate capacity for the device and properly grounded, in accordance with laws and/or regulations in force.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 FIRST START-UP The time required to start the steriliser is approximately 30 seconds. 5.1. STARTING Once the steriliser has been correctly installed, turn it on with the main switch on the right-hand side of the machine.
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 Then the cloud connection page is displayed. Refer to G4 Cloud paragraph (12.5). Press “home” to complete the first start procedure. G4 Cloud Online Access Activation screen (if not previously setup) can be displayed at any time by clicking on the Cloud icon.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 5.2. MAIN MENU At the end of starting procedure the main menu is displayed on the side. The steriliser waits for the program selection (see "Program selection" Chapter). 5.3. FILLING DEMINERALISED / DISTILLED WATER Only use demineralised / distilled water having the following characteristics to supply the steriliser.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 CONFIGURATION The sterilisers offer a wide range of customisable options. The user can thus configure the device according to their own needs, adapting the performance based on, for example, the type of activity carried out, the type of material to be sterilised and the frequency of use.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.2. DATE AND TIME Select DATE AND TIME option. Select the field to be modified using the arrows and confirm using ENTER. 6.1.3. REMINDER This function allows displaying, according to the selected interval, a message recalling the execution of the relative test.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.4. USERS The users list can be edited with 10 users max. Press USERS button to enter the menu. When using the device for the first time create the ADMIN user (identified by *) following the indications in the figure on the side.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.4.1. USERS LIST Press USERS button to enter the menu. Select the desired user. You will access the screen containing data of the selected user. Once entered, a generic user can see only a summary of their data, or change their PIN (see entering PIN - the following is requested in sequence: current PIN, new PIN, new PIN confirmation).
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.5. PREFERENCES Press PREFERENCES button to enter the menu and set: • UNITS OF MEASUREMENT • DISPLAY • WATER FILLING • PREHEATING...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.5.1. UNIT OF MEASUREMENT Press the MEASUREMENTS icon to set the desired units of measurement (temperature, pressure), the time (12 or 24 hours) and the date format using the cursors shown in the figure.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.5.3. WATER FILLING Press the H2O FILLING icon to choose the type of water filling. Available options include: • Manual filling • Pure 100 • Pure 500 • External pump, automatic filling kit •...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 6.1.5.4. PREHEATING Select the PREHEAT icon to activate PREHEATING in the sterilisation chamber. Select ON to activate PREHEATING. Confirm by pressing ENTER. The arrows allow setting the maximum operating time, after which the warming is disabled.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 PREPARATION OF THE MATERIAL Always use personal protective equipment. Take the following precautions when handling and managing contaminated material: • Wear rubber gloves of suitable thickness and the specific protective mask on your face;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 7.2. ARRANGING THE LOAD Always use personal protective equipment. To get the best effectiveness of the sterilisation process and preserve the material over time, increasing its useful life, follow the instructions below.
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 Notes for packed material: • Individually pack the instruments or, in case several instruments are placed inside the same bag, make sure they are made of the same metal;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 7.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT Tray holder support can be used in "tray" version (5/6 compartments based on the steriliser model). It can be used to house special "cassettes" (3/4 compartments based on...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 STERILISATION CYCLES A sterilisation cycle consists of a determined number of phases. The number and duration of the phases can differ for the various cycles, based on the type of air extraction, sterilisation process and drying methods: •...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 8.1. EXTRA DRYING To set parameters, press and hold the following button: Set the minutes of drying you want to add to the standard drying time and confirm with ENTER.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 8.2. DELAY START To set parameters, press and hold the following button: Set the time you want to start the cycle selected and confirm with ENTER. The selected time appears near the button.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 8.3. EXECUTION OF THE CYCLE Taking as an example the most complete and significant sterilisation cycle, i.e. the B 134°C UNIVERSAL program, characterised by fractionated pre-vacuum, the cycle sequence is as follows:...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 8.6. USER-DEFINED CYCLE To set parameters, select the following button: Hold down the following button to access settings: Select the type of pre-vacuum (fractionated or single), the process temperature, the exposure time and total drying time.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 MATERIAL STORAGE The sterilised material must be adequately treated and stored to maintain its sterility over time until its use. For this reason, we think it will be useful to provide several basic suggestions, leaving the operator the task of further study of specific texts.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 10. TEST PROGRAMS To protect the safety of users and patients, a fundamental process like sterilising medical devices should be periodically checked. The device offers the possibility of easily and automatically executing two distinct test cycles: •...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 The HELIX test device (in accordance with EN 867-5 specifications) consists of a 1.5 m-long PTFE tube, with an inside diameter of 2 mm to which a small hermetically-sealed screw cap is fastened, able to contain an appropriate chemical indicator.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 10.3. VACUUM TEST + HELIX TEST / B&D TEST CYCLE Select this option to run a VACUUM TEST cycle and a Helix Test/B&D cycle in sequence. To this end, place the test device on the central tray without inserting other material.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 10.5. DOOR OPENING To open the autoclave door, press and hold the button shown in the figure. The door opens and stays ajar. Now you can manually open the door.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 10.6. MANUAL INTERRUPTION The cycle can be interrupted by the operator in any moment, by holding down the key indicated in the figure for about three seconds. The command generates E999 error since the cycle could not finish correctly.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 11. USED WATER DRAIN When the water maximum level is reached, a specific message is displayed. Open the door and continue as follows: Detaching the tube Prepare a basin with a capacity of at least 4 litres in proximity to the steriliser;...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 12.1. USB MANAGEMENT Before carrying out the following operations insert the USB key. It is possible to copy data about the cycles carried out, stored in the internal memory of the steriliser, on a USB key.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 12.1.1. DIRECT DOWNLOAD This control performs the download of the NEW cycle reports, as PDF file, by means of a USB memory. As NEW indicates the cycle reports have not previously been dowloaded before.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 12.2. WIFI Select Wi-Fi to connect the steriliser to a local Wi-Fi network. Select ON/OFF to enable or disable Wi-Fi connection. Select SETTINGS button to configure the network. Choose NET SELECTION to insert the network and the password.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 Choose NET CONFIGURATION to configure the network. DHCP can be set as automatic or manual. In automatic mode the network configuration parameters are assigned automatically, in manual mode the network configuration parameters must be set manually.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 12.4. ETHERNET Select ETHERNET to connect the steriliser to a local Ethernet network DHCP can be set as automatic or manual. In automatic mode the network configuration parameters are assigned automatically, in manual mode the network configuration parameters must be set manually.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 13. APPENDIX – PROGRAMS Steam sterilisation is suitable for almost all the materials and instruments, provided that they can bear without damage a minimum temperature of 121°C (if this is not the case, other low-temperature sterilisation systems must be used).
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 BASIC CYCLE NOMINAL VALUES STERILISABLE MATERIALS NOTES PARAMETERS CYCLE DESCRIPTION It is advisable to Solid instruments in 5.00 1.00 0.25 use the 3-tray single pack 134°C SOLID configuration 4(*)
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 PRESSURE, TIME AND TEMPERATURE In compliance with EN 13060:2014 + A1:2018 for operating cycles 134°C cycles EN 13060:2014 + Min. pressure Max. pressure Time (minutes) Min. temperature Max. temperature...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 13.5. DIAGRAMS OF THE TEST PROGRAMMES PROGRAM PRESSURE (BAR) HELIX B&D TEST PROCESS 134°C – 3’0’’ TIME (MIN) FRACTIONATED PRE-VACUUM SHORT DRYING PROGRAM PRESSURE (BAR) VACUUM TEST TIME (MIN) -0.80 bar...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 13.6. EXAMPLES OF PRINTED REPORTS (WITH OPTIONAL PRINTER) PROGRAM PRINTING (STANDARD) PROGRAM PRINTING HELIX/B&D TEST PROGRAM PRINTING VACUUM TEST The text printed on the receipt remains for a couple of years, if correctly stored (away from any source of heat and in a cool, dry place). Store...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 14. APPENDIX - MAINTENANCE In addition to correct use, the user needs to perform regular maintenance in order to guarantee safe, efficient operation over the device’s entire life. Always use personal protective equipment.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 14.2. SCHEDULED MAINTENANCE MESSAGES The steriliser periodically displays warning messages relevant to "routine" maintenance operations that must be carried out in order to ensure the proper operation of the device.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 14.3. DESCRIPTION OF MAINTENANCE INTERVENTIONS Let’s now look at the various operations to be carried out. 14.3.1. DOOR GASKET AND THE INTERNAL PART OF THE DOOR CLEANING To eliminate any traces of limescale, clean the gasket of the chamber and the door porthole with a clean cotton cloth soaked in a soft solution of water and vinegar (or a similar product, checking the contents on the label before using).
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 14.3.6. ANTI-DUST FILTER CLEANING Remove the filter (A) from the lower part of the autoclave, thoroughly rinse it with water and dry it before refitting it. The filter can be cleaned using a jet of compressed air, making sure not to disperse any dust into the environment.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 14.4. PERIODIC STERILISER VALIDATION As happens with all devices, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components along their lifespan, in a period of time dependent on its frequency of use.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 15. APPENDIX - GENERAL PROBLEMS If while using the device a problem or an alarm occurs, this DOES NOT mean that the device is out of order. It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a blackout), or incorrect use.
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 PROBLEM POSSIBLE CAUSE SUGGESTED SOLUTION Separate instruments made of different metals. Contact between instruments made of different (See Chapter “Preparing the material”). metals. Clean the chamber and the accessories as prescribed.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 16. APPENDIX – ALARMS If the problem persists, contact the technical service (see APPENDIX) communicating the steriliser model and serial number. These data are indicated on the registration plate on the rear side of the device, on the declaration of conformity and can also be viewed by means of the “steriliser information”...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 17. ALARM CODES The list of alarm codes, the relevant messages displayed and RESET modes, are indicated in the following table: 17.1. ERRORS (CATEGORY E) The alarm codes in the list can refer to functions that are not present on the models concerned in this Manual...
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE The cloud firmware version is not the correct one with respect to the INCORRECT FW VERSION CLOUD E141 firmware process. There may be malfunctions in the connection with...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 17.2. ALARMS (CATEGORY A) CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE FILL.WATER LEVEL A032 Problem with the level sensor of the filling tank SENSOR PROBLEM CONTACT TECH.SERVICE DISCH.WATER LEVEL...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 17.5. TROUBLESHOOTING According to the type of alarm occurred, please find below the indications to detect the possible causes and restore the proper operation: 17.5.1. ERRORS (CATEGORY E) The alarm codes in the list can refer to functions that are not present on the models concerned in this Manual...
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 CODE POSSIBLE CAUSE SUGGESTED SOLUTION Contact Technical Service MIN. water level sensor failure. (see Appendix). RESET according to the instructions and empty the tank. Water level in the drain tank over the MAX. level.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 17.5.2. ALARMS (CATEGORY A) CODE POSSIBLE CAUSE SUGGESTED SOLUTION Connector of water level sensors in the filling tank not connected. A032 Contact Technical Service (see Appendix). Failure of water level sensor(s) in the filling tank.
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 CODE POSSIBLE CAUSE SUGGESTED SOLUTION RESET according to the instructions. Thoroughly dry the inside of the sterilisation chamber and restart the cycle. Water or condensate in the sterilisation chamber.
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Bravo G4 17 / Bravo G4 22 / Bravo G4 28 CODE POSSIBLE CAUSE SUGGESTED SOLUTION RESET according to the instructions. Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water and restart the program.
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 17.5.4. SYSTEM ERRORS (CATEGORY S) CODE POSSIBLE CAUSE SUGGESTED SOLUTION Error of Flash memory 1 on process board S001 Contact Technical Service (see Appendix). Flash memory 1 on process board failed...
Bravo G4 17 / Bravo G4 22 / Bravo G4 28 18. USER PIN RESET If the user enters the pin incorrectly for 3 times, it is necessary to enter the following unlock pin for four consecutive times when you will be...
20. PRINTER CONNECTION Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure). Load the desired type of paper and turn on the printer. Set the type of paper loaded (see the paragraph PRINT MANAGEMENT). Refer to the printer manual for printer starting and paper loading.
We will gladly provide any information you may need on the product as well as give you suggestions and advice on the steam sterilisation procedures. In this regard, please refer to the following address: Head Office: SciCan Ltd. 1440 Don Mills Rd. Toronto, ON, Canada, M3B 3P9...
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