SciCan BRAVO 17, BRAVO 17V, BRAVO 21V Operator's Manual

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BRAVO 2 Operator’s Manual 95-XXXXXX Rev. 1.0 Copyright 2012 SciCan Ltd. All rights reserved.
• Operator’s Manual
BRAVO
AUTOCLAVES
ref. 97050531 rev. 0 - 04/2012 SD-310/1-EN
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IIII
INTRODUCTION ...................................................................................................................................1
SYMBOLS USED IN THE MANUAL......................................................................................................................................1
SYMBOLS ON EQUIPMENT ................................................................................................................................................1
DISCLAIMERS ...................................................................................................................................................................... 1
GENERAL WARNINGS .........................................................................................................................................................2
CONTENTS OF THE PACKAGE ...........................................................................................................3
DIMENSIONS AND WEIGHT ................................................................................................................................................3
DESCRIPTION OF THE CONTENTS ....................................................................................................................................3
HANDLING THE PRODUCT .................................................................................................................................................4
CAP REMOVAL FROM THE TANK BREATHER HOLE (IF NECESSARY) .............................................................................4
PRODUCT OVERVIEW .........................................................................................................................................................5
GENERAL CHARACTERISTICS............................................................................................................................................5
FRONT .................................................................................................................................................................................. 6
REAR ....................................................................................................................................................................................7
VERSION WITH AUTOMATIC LOADING WITH PUMP ...................................................................................................7
CONTROL PANEL ................................................................................................................................................................8
LCD DISPLAY .......................................................................................................................................................................8
SAMPLE OPERATING CYCLE ..............................................................................................................................................9
INSTALLATION ....................................................................................................................................10
INTRODUCTION ................................................................................................................................................................. 10
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS ...................................................................................... 10
GENERAL INSTALLATION PRECAUTIONS .......................................................................................................................11
ELECTRICAL CONNECTIONS............................................................................................................................................11
CONNECTION OF USB PEN DRIVE RECORDING DEVICE .............................................................................................. 11
MANAGING THE FILES BY DATAFLASH SW ....................................................................................................................12
LAUNCHING THE PROGRAM ......................................................................................................................................12
DIALOGUE WITH THE DEVICE ..................................................................................................................................... 12
SAVING THE REPORT FILE ..........................................................................................................................................13
REPORT FILE MANAGEMENT......................................................................................................................................13
FILE NAME .................................................................................................................................................................... 14
FILES VISUALIZATION .................................................................................................................................................. 14
CONNECTING AN EXTERNAL WATER FILLING TANK .....................................................................................................15
DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT ......................................................................................16
FIRST START-UP ................................................................................................................................. 17
TURNING ON THE EQUIPMENT ........................................................................................................................................ 17
INITIAL AUTOMATIC TEST ................................................................................................................................................. 17
ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES ......................................................................... 17
STAND-BY MODE ............................................................................................................................................................... 18
FILLING DISTILLED WATER .............................................................................................................................................. 19
MANUAL FILLING (TOP SIDE) ...................................................................................................................................... 19
MANUAL FILLING (FRONT SIDE) .................................................................................................................................19
AUTOMATIC FILLING.................................................................................................................................................... 20
MAX LEVEL IN THE INTERNAL / EXTERNAL DRAIN TANK .............................................................................................. 20
EMPTYING THE USED WATER INTERNAL TANK ........................................................................................................20
DETACHING THE PIPE ................................................................................................................................................. 20
CONFIGURATION ............................................................................................................................... 21
INTRODUCTION ................................................................................................................................................................. 21
STARTING AND ENTERING THE SETUP MODE ............................................................................................................... 21
MEANING OF THE KEYS IN SETUP MODE ....................................................................................................................... 21
DESCRIPTION OF THE MENU ITEMS ...............................................................................................................................23
DEFAULTS SETTINGS ........................................................................................................................................................ 25
ACTIVATING CONFIGURATION OPTIONS .........................................................................................................................25
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SETTING THE LANGUAGE ........................................................................................................................................... 25
(LANGUAGE ON THE BASIC MENU) ...........................................................................................................................25
SETTING THE DATE ...................................................................................................................................................... 25
SETTING THE TIME ...................................................................................................................................................... 26
SETTING THE PASSWORD ..........................................................................................................................................26
SETTING THE STERILIZATION PROGRAMS ............................................................................................................... 27
SETTING THE STAND-BY MODE ................................................................................................................................. 31
SETTING THE PRINTING MODE ..................................................................................................................................32
SETTING THE TANK FILLING MODE ........................................................................................................................... 34
ACQUISITION OF THE AMBIENT PRESSURE .............................................................................................................35
ADJUSTING THE CONTRAST OF THE LIQUID CRYSTAL DISPLAY ............................................................................36
EXIT THE CONFIGURATION MODE ................................................................................................................................... 36
PREPARING THE MATERIAL .............................................................................................................37
INTRODUCTION ................................................................................................................................................................. 37
TREATING TEXTILE MATERIAL BEFORE STERILIZATION ................................................................................................ 37
TREATING THE LOAD BEFORE STERILIZATION ...............................................................................................................37
ARRANGING THE LOAD ....................................................................................................................................................38
STERILIZATION MONITORING........................................................................................................................................... 39
PROGRAM ........................................................................................................................................... 40
SELECTION .........................................................................................................................................40
INTRODUCTION ................................................................................................................................................................. 40
PROCEDURE ...................................................................................................................................................................... 40
RUNNING THE CYCLE .......................................................................................................................42
INTRODUCTION ................................................................................................................................................................. 42
STARTING THE CYCLE ...................................................................................................................................................... 42
PROGRAM EXECUTION ..................................................................................................................................................... 43
RESULT OF THE CYCLE .................................................................................................................................................... 47
CHECK OF THE CYCLE DATA REPORT ...........................................................................................................................48
STORING DATA ON THE USB KEY ....................................................................................................................................48
MANUAL CYCLE INTERRUPTION .....................................................................................................................................48
STORING STERILIZED MATERIALS.................................................................................................. 50
INTRODUCTION ................................................................................................................................................................. 50
HANDLING ..........................................................................................................................................................................50
STORAGE ........................................................................................................................................................................... 50
TEST PROGRAMS ..............................................................................................................................51
INTRODUCTION ................................................................................................................................................................. 51
HELIX/BD TEST .................................................................................................................................................................. 51
VACUUM TEST ...................................................................................................................................................................52
APPENDIX A – TECHNICAL CHARACTERISTICS ............................................................................ 55
SUMMARY TABLE .............................................................................................................................................................. 55
SAFETY DEVICES ............................................................................................................................................................... 56
WATER SUPPLY CHARACTERISTICS ................................................................................................................................57
APPENDIX B – PROGRAMS ............................................................................................................... 58
INTRODUCTION ................................................................................................................................................................. 58
PROGRAM SUMMARY TABLE ........................................................................................................................................... 59
DIAGRAMS OF THE TEST PROGRAMMES ....................................................................................................................... 66
EXAMPLES OF PRINTED REPORTS ..................................................................................................................................67
APPENDIX C – MAINTENANCE ......................................................................................................... 69
INTRODUCTION ................................................................................................................................................................. 69
ROUTINE MAINTENANCE .................................................................................................................................................. 69
SCHEDULED MAINTENANCE MESSAGES .................................................................................................................69
III
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BRAVO and Your Infection Control Specialist are a trademarks of SciCan Ltd. All other trademarks referred to in this manual are the property of their respective owners.
Manufactured by:
SciCan Ltd.
1440 Don Mills Road, Toronto ON M3B 3P9 CANADA Phone: +1-416-445-1600 Fax: +1-416-445-2727 Toll free: 1-800-667-7733
0123
SciCan Inc.
701 Technology Drive Canonsburg, PA 15317 USA Phone: 724-820-1600 Toll Free: 1-800-572-1211 Fax: 724-820-1479
SciCan Medtech
Alpenstrasse 16 6300 Zug, Switzerland Tel: +41 (0) 41-727-7027 Fax: +41 (0) 41-727-7029
EC Representative
SciCan GmbH Wangener Strasse 78 88299 Leutkirch GERMANY Tel.: +49 (0) 7561-98343-0 Fax: +49 (0) 7561-98343-699
For all service and repair inquiries
Canada: 1-800-870-7777 United States: 1-800-572-1211 EU +49 (0) 7561 98343-641 International +1 (416) 445-1600 Email: techservice.ca@scican.com (Canada) techservice.us@scican.com (USA) techservice.int@scican.com (International)
IV
IV
MAINTENANCE DESCRIPTION ......................................................................................................................................... 71
CLEAN GASKET AND PORTHOLE ..............................................................................................................................71
TO REMOVE ANY TRACES OF LIME ...........................................................................................................................71
CLEAN EXTERNAL SURFACES ....................................................................................................................................71
CLEAN STERILIZATION CHAMBER AND ACCESSORIES .......................................................................................... 71
DISINFECT EXTERNAL SURFACES .............................................................................................................................71
CLEANING THE INTERNAL TANK ................................................................................................................................ 72
CLEAN EXTERNAL DISTILLED WATER TANK ..............................................................................................................72
SAFETY VALVE MAINTENANCE .................................................................................................................................. 72
CLEAN/REPLACE THE DRAIN FILTER ......................................................................................................................... 73
REPLACE BACTERIOLOGICAL FILTER ........................................................................................................................ 73
REPLACING THE PRINTER PAPER .............................................................................................................................73
PERIODIC STERILIZER MAINTENANCE (EVERY 3000 CYCLES) ......................................................................................74
APPENDIX D – TROUBLESHOOTING ...............................................................................................75
INTRODUCTION ................................................................................................................................................................. 75
ANALYSIS AND RESOLUTION OF PROBLEMS................................................................................................................. 75
APPENDIX E – ALARMS ..................................................................................................................... 78
INTRODUCTION ................................................................................................................................................................. 78
ALARM INTERVENTION .....................................................................................................................................................78
ALARM DURING A CYCLE ........................................................................................................................................... 78
ALARM OUTSIDE THE CYCLE .................................................................................................................................... 79
RESETTING THE SYSTEM ................................................................................................................................................ 80
ALARM CODES ..................................................................................................................................................................81
ANALYSIS AND RESOLUTION OF PROBLEMS................................................................................................................. 83
APPENDIX F – NOTES FOR THE OPERATOR .................................................................................. 89
APPENDIX G – TECHNICAL SUPPORT ............................................................................................90
APPENDIX H – LIMITED WARRANTY ...............................................................................................91
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Congratulations on your selection of the Bravo™ Autoclave. We are con dent that you have purchased the  nest equipment of its type. The Bravo is a counter-top unit that features a number of sterilizing cycles designed to meet your needs and suitability for steam sterilization. The details of installing, operating and maintaining your Bravo are all contained within this operator’s manual. To ensure years of safe, trouble-free service please read these instructions before operating this unit and keep them for future reference. Operational, maintenance and replacement instructions should be followed for the product to perform as designed. Contents of this manual are subject to change without notice to re ect changes and improvements to the Bravo product.
NOTE
this symbol indiCates important information.
WARNING
THIS SYMBOL INDICATES A POTENTIAL DANGER OF INJURY. FOLLOW THE PRO­CEDURES DESCRIBED IN THE MANUAL TO AVOID INJURING THE USER AND/OR OTHERS.
DANGER
THIS SYMBOL INDICATES A POTENTIAL DANGER OF PROPERTY DAMAGE. FOL­LOWS THE INSTRUCTIONS IN THE MANUAL TO PREVENT POTENTIAL DAMAGE TO MATERIALS, EQUIPMENT OR OTHER PROPERTY.
DANGER
THIS SYMBOL INDICATES A POTENTIAL DANGER DUE TO HIGH TEMPERATURE.
THE MATERIAL THE STERILIZER IS COMPOSED OF MUST BE DISPOSED ACCOR­DING TO THE DIRECTIVE 2002/96/CEE.
Potenzial hazard due to high temperature.
Equipment in accordance with applicable directives.
Symbol for disposal in accordante with Directive 2002/95 EC, 2002/96/ EC, and 2003/108/ EC.
Consult the user manual.
The Bravo units described in this manual are to be used exclusively for the sterilization of solid and hollow re-usable instruments and porous materials (e.g., textiles).
WARNING
THE DEVICE MUST ONLY BE USED BY QUALIFIED PERSONNEL. IT MAY NOT BE USED OR HANDLED BY INEXPERT AND/OR UNAUTHORIZED PERSONNEL FOR ANY REASON. THIS DEVICE MUST NOT BE USED FOR THE STERILIZATION OF FLUIDS, LIQUIDS OR PHARMACEUTICAL PRODUCTS.
Do not permit any person other than certi ed personnel to supply parts for, service or maintain your Bravo. SciCan shall not be liable for incidental, special or consequential damages caused by any maintenance or services performed on the Bravo by a third party, or for the use of equipment or parts manufactured by a third party, including lost pro ts, any commercial loss, economic loss, or loss arising from personal injury.
Never remove the cover of the unit and never insert objects through holes or openings in the cabinetry. Doing so may damage the unit and / or pose a hazard to the operator.
All elements of this book are common to Bravo17, Bravo17V and Bravo21V, except where noted.
DISCLAIMERS
SYMBOLS ON EQUIPMENT
SYMBOLS USED IN THE MANUAL
INTRODUCTION
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Please observe the following precautions in order to avoid injury or property damage:
– Use ONLY distilled water of high quality.
WARNING
THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY DAMAGE THE DEVICE. SEE APPENDIX A, TECHNICAL CHARACTERISTICS IN THIS REGARD.
– Do not pour water or other liquids on the device; – Do not pour inammable substances on the device; – Do not use the device in the presence of gas or explosive or inammable vapors; – Before performing any maintenance or cleaning, ALWAYS DISCONNECT the electricity.
WARNING
WHENEVER IT IS NOT POSSIBLE TO DISCONNECT THE ELECTRICITY TO THE DEVICE, OR IF THE EXTERNAL POWER GRID SWITCH IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE EXTERNAL POWER GRID SWITCH AFTER TURNING IT OFF .
– Make sure the electrical system is grounded conforming to current laws and/or standards; – Do not remove any label or nameplate from the device; request new ones, if necessary; – Use only original replacement parts.
WARNING
THE FAILURE TO OBSERVE THE ABOVE, RELEASES THE MANUFACTU­RER FROM ALL LIABILITY.
GENERAL WARNINGS
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2
3
4
6
8
11
12
14 - 15
13
10
7
5
1
9
16
17
18
19
B
A
C
NOTE
CheCk the integrity of the paCkage upon
reCeipt.
Once the package is opened, check that:
– the content matches the specications of the order
(see the accompanying document);
– that there is no obvious product damage;
Dimensions and weight 17 and 17V 21V
A. Height 600 mm 600 mm
B. Width 580 mm 580 mm
C. Depth 700 mm 800 mm
Total weight 62 kg 68 kg
NOTE
if you have reCeived the wrong produCt, are missing parts, or if your unit has any
type of damage, immediately provide a detailed desCription to the seller and shipper.
In addition to the steriliser, the package contains:
1. No. 3 stainless steel wire instrument tray
(BRAVO 17 includes 3 trays, BRAVO 17V/21V includes 5 trays);
2. Stainless steel wire tray support;
3. Operating documentation (with CD-ROM);
4. USB key for data storage;
5. Exhaust lter;
6. Tray extractor;
7. Water lling funnel;
8. Extra bacteriological lter;
9. Rubber hose with quick-coupling for manual water drainage;
10. 4 rubber caps;
11. 1/8” angular tting;
12. Spare roll of printer paper (optional);
13. Plastic tube with tting (automatic lling);
14. Allen wrench (3mm for rear cap removal);
15. Allen wrench (5mm for handle removal);
16. Plastic tube for direct water drainage with fastening clamp;
17. Bottle for manual lling;
18. No. 2 spacers;
19. Syringe.
NOTE
the Customer must keep the purChase reCeipt for any warranty serviCe.
DIMENSIONS AND WEIGHT
DESCRIPTION OF THE CONTENTS
CONTENTS OF THE PACKAGE
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Where possible, the packaged product must be handled using suitable mechanical means (forklift truck, transpallet, etc.) and following the instructions shown on the package. In the case of manual handling, the product must be lifted by two persons using the handles cut in the side of the box.
Once taken out of the box, the sterilizer must be lifted by two persons and transported on a lift truck or similar means.
WARNING
WE RECOMMEND THAT THE DEVICE BE TRANSPORTED AND STORED AT A TEMPERATURE NO LOWER THAN 5 °C. PROLONGED EXPOSURE TO LOW TEMPERATURE AN DAMAGE THE PRODUCT.
NOTE
keep the original paCkaging and use it whenever the deviCe is to be transported. the
use of different paCkaging Could damage the produCt during shipment.
DANGER
BEFORE TRANSPORT, LEAVE THE DEVICE TURNED-OFF FOR ABOUT 30 MINUTES AFTER THE LAST PROGRAM FINISHES AND DRAIN THE DISTIL­LED WATER AND USED WATER TANKS SO THAT THE ALL THE HOT INTER­NAL PARTS WILL HAVE TIME TO COOL.
HANDLING THE PRODUCT
CAP REMOVAL FROM THE TANK BREATHER HOLE (IF NECESSARY)
There may be a cap on the breather hole. If present, the protection cap must ALWAYS be removed from the breather hole of the distilled water tank before starting the sterilizer. Use the Allen wrench provided with the device and follow the procedure shown in the gure.
WARNING
FAILURE TO REMOVE THE CAP MAY CAUSE THE DEVICE NOT TO WORK PROPERLY AND ITS INTERIOR COMPONENTS BEING DAMAGED. MAKE SURE YOU FOLLOW THE PROCEDURE DESCRIBED ABOVE BEFO­RE INSTALLING THE DEVICE.
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Bravo is SciCan's revolutionary chamber autoclave designed with safety, performance, exibility and ease of use in mind.
It is a sophisticated yet easy-to-use sterilizer with a wide range of conguration options and patented operating devices designed to satisfy every need for sterilizing medical and dental tools, guaranteeing the maximum performance under all conditions.
Easy-to-use, compact and aesthetically pleasing, Bravo is the ideal partner for professionals seeking maximum sterilization safety.
PRODUCT OVERVIEW
GENERAL CHARACTERISTICS
Bravo is a microprocessor-controlled steam sterilizer with a large sterilization chamber made of stamped stainless steel.
It is characterized by an advanced fractionated vacuum system for the complete removal of air from hollow and porous materials, and an effective nal vacuum drying phase capable of effective drying of these loads.
Its exclusive steam generation system, effective plumbing circuit and electronic management (supplemented by high-precision sensors) guarantees high process execution speeds and excellent thermodynamic parameter stability. Moreover, its Process Evaluation System constantly monitors all the machine's vital parameters in real-time, guaranteeing absolute safety and perfect results.
It offers users 10 sterilization programs (one customizable), each equipped with optimized drying for the fast, effective sterilization of the various types of loads (instruments and materials) used in a medical or dental environment. The custom programs have not been validated and have not been cleared in the U.S. by FDA for healthcare use.
Bravo units also offer a number of interesting options for conguring the preheating mode (based on the sterilizer's frequency of use) and printing the cycle report (printer optional on Bravo17).
Bravo sterilizers also have one of the most complete, sophisticated and advanced safety systems available today to protect users in the case of electrical, mechanical, or thermal operating anomaly.
NOTE
please refer to appendex a (teChniCal CharaCteristiCs) for a desCription of bravo's
unintegrated safety deviCes.
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FRONT
LCD display and con­trol panel
Sterilization chamber
Door
Door microswitch
Service compartment access panel
Bacteriological lter
Printer paper output slot
USB port
Exhaust lter
Encased printer (op­tional)
Service compartment open
On/Off switch
Motorized closing sy­stem
Used water drain quick connector
Distilled water ll quick connect
Door
Distilled water tank drain quickcoupling (SERVICE only)
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REAR
Distilled water tank vent hole
Heat exchanger
Safety valve
Connection for auto­matic loading of the load tank
Connection for di­rectly draining the used water tank
Band heating element safety thermostat and manual rearm
Power cord
Steam generator safety thermostat and manual rearm
Mains fuses
Version with automatic loading with pump
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-
+
CONTROL PANEL
LCD DISPLAY
Liquid Crystal Display (LCD)
Command keys
The function of the command keys differ according to operating mode of the equipment.
Key NORMAL mode SETUP mode
Cycle Start/Stop
Enter, con rmation of the value/option se­lected
+
+
+
Sterilization cycle selection
Value increment / Forward scroll of the menu options
-
-
-
Test cycle selection
Value decrement / Backward scroll of the menu options
Enter Setup mode ESC, quit the current menu
Alarm
Setup status
Process status
Port status
Water level
4 lines of 20 characters
Illuminated icon
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The Bravo’s sterilization program is a succession of phases, each with a specic purpose.
After loading the material in the chamber, closing the door, selecting the program and starting the cycle (the door opening mechanism locks automatically), the standard program (for porous materials, 134 °C at 4 minutes, for example) uses the following sequence:
1. Preheats the generator and sterilization chamber;
2. Removes the air and penetrates the material by steam through a series of vacuum (extracting uid from the sterilization chamber) and pressure (injecting steam into the chamber) phases;
3. Raises the pressure, with the consequent increase in the temperature of the steam, until reaching the conditions required for sterilization (for example, 134 °C);
4. Stabilizes the pressure and temperature;
5. Sterilizes for the required time (for example, 4 minutes);
6. Depressurizes the sterilization chamber;
7. Begins vacuum-drying phase;
8. Ventilates the load with sterile air;
9. Brings the pressure of the sterilization chamber back to the atmospheric level.
After reaching atmospheric pressure, the door is automatically unlocked and can be opened to remove the load from the sterilization chamber.
Phases 1, 3, 4, 6 and 9 are identical in all cycles, with slight variations of duration that are solely dependent on the quantity and consistency of the load and the heating conditions of the steri­lizer. Phases 2, 5, 7 and 8, however, vary their conguration and/or duration on the basis of the cycle selected (and, consequently, the type of load) and the choices made by the user.
NOTE
please refer to appendix b (programs) for more detail.
SAMPLE OPERATING CYCLE
0.00
1.00
2.00
2.10
Pressure (bar)
Time (
min)
VACUUM DRYING
PROC ESS
SINGLE VACUUM PULSE
-0.80
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A
C
B
C
B
A
Correct and careful installation will ensure your Bravo functions properly, protects operators from physical injury and protects property from damage.
Dimensions and weight 17 and 17V 21V
A. Height (total, excluding handles)
420 mm /
16.5"
420 mm /
16.5"
B. Width (total)
480 mm / 19"
480 mm / 19"
C. Depth (excluding rear con­nections)
560 mm /
22.0"
660 mm /
25.0"
Total weight
58 kg / 128 lbs
63 kg / 139 lbs
Electricity
The electrical system to which the sterilizer will be connected must accommodate the electrical characteristics of this device. This information is shown on the back of the machine.
When installing the sterilizer inside a cabinet, you must provide adequate space all around the device to provide effective ventilation. There should also be an opening in the back large enough to provide adequate air ow. This will allow optimum cooling of the heat exchanger.
A built-in compartment MUST have the minimum dimensions shown in the gure at right.
Dimensions and weight 17 and 17V 21V
A. Height (total) 500 mm / 20" 500 mm / 20"
B. Width (total) 600 mm / 24" 600 mm / 24" C. Depth 600 mm / 24" 700 mm / 28"
WARNING
COMPARTMENT DIMENSIONS LESS THAN THOSE SHOWN MAY COMPROMISE THE CORRECT CIRCULATION OF AIR AROUND THE DEVICE AND MAY NOT PROVIDE ADEQUATE COOLING. THIS CAN RESULT IN THE DETERIORATION OF PERFORMANCE AND/OR POSSIBLE DAMAGE.
NOTE
do not remove the upper Cover or any other external part. when installed in the Compartment, the deviCe must be Complete with all its parts. please refer to appendix a (teChniCal CharaCteristiCs) for Complete teChniCal data.
INSTALLATION
INTRODUCTION
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS
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To ensure operator safety and the correct performance of the device:
GENERAL INSTALLATION PRECAUTIONS
ELECTRICAL CONNECTIONS
CONNECTION OF USB PEN DRIVE RECORDING DEVICE
– Install the sterilizer on a at level surface strong enough
to support the device's weight, and use the leveling feet to compensate for an irregular surface;
– Leave adequate space for ventilation, at least 2" (50 mm) on
both sides and top and 4" (100 mm) at the back, using the spacers supplied in the toolkit. If the device is installed in a cabinet, be sure to respect the warnings in the preceding paragraph, avoiding any obstructions to the air intake;
– Avoid contact with liquids. Do not install the sterilizer near
tubs, sinks or similar places, as this could cause short circuits and/or potentially dangerous situations for the operator;
– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
– Do not install the machine were there is gas or ammable and/or explosive vapors;
– Install the device so that the power cord is not sharply bent or kinked. It must run freely to the
electrical connection socket;
– Install the device so that any external ll/drain tubing(s) is/are not sharply bent or kinked.
These must run freely to the drain tank.
The Bravo must be connected to an outlet that provides adequate capacity for the device's absorption and ground, and which conforms with current laws and/or standards. The outlet must also be protected by suitable breaker.
WARNING
THE MANUFACTURER WILL NOT BE LIABLE FOR DAMAGES CAUSED BY INSTALLING THE STERILIZER ON AN INADEQUATE ELECTRICAL SYSTEM AND/OR NOT EQUIPPED WITH A GROUND.
If it is necessary to replace the plug on the power cord, use one with equal characteristics or, at any rate, adequate to the device's electrical characteristics. The user is entirely responsible for the selection and replacement of the plug. This replacement should only be performed by a trained service professional.
NOTE
always ConneCt the power Cord direCtly to the soCket. do not use extension
Cords, adapters or other aCCessories.
The recorded DATA can be copied, read and printed using DataFlash software installed on a compatible personal computer that is tted with a USB port. Installation of the DataFlash software stored on the CD-rom and attached to the operating documentation.
– Insert the cd-rom into the CD drive of the PC.
– Click on “setup_DataFlash [rev]”.
– Follow the installation instructions that appear on the display. During installation, a "DataFlash"
folder is created which contains the necessary les.
– In addition, a programme icon is created on the PC's desktop.
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DataFlash software is a programme for Windows (versions 98, XP, and Vista) that allows users to download data contained in the USB key to the PC and then and process that data.
Launch the DataFlash program from its desktop icon, or select the executable program le.
After launching the program, a window appears containing the le reports folder (on the rst launch it will be empty). Click on the “USB” button to enable the connection to DataFlash.
note
the usb key must be ConneCted to the pC when the programme is started
otherwise an error message will appear.
A second window appears, containing the le list related to the stored sterilization cycles.
MANAGING THE FILES BY DATAFLASH SW
Launching the program
Dialogue with the device
Reading of data stored on the USB key
Saving the les on the PC.
Cancellation of USB key memory
List of stored les
Percentage of used me-
mory
NOTE: the keys functions are also pre­sent as sub-menus in the menu bar
Status bar
USB key storage capacity
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Saving the Report fi le
Report fi le management
To save  les stored on the USB key to the PC, select the Save key (or File-Save from menu). The three keys and the window menu are disabled during the save process; the mes­sage “Ready” in the status bar shows is replaced by “Saving...”, followed by a number and by a progress bar that shows the progress of the save process for the individual  les.
At the end of the save process (status “Ready” and function keys enabled), close the window for the dialogue with the device and proceed to the management of the  les saved on the PC.
The  les are saved according to the cycle date in a directory automatically generated by the program and made up of folders for the years and subfolders for the months.
The  les names are assigned on the basis of the cycle data, type, size and date of modi cation of  les are also included.
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The les saved on the PC are named “Mocom register”. Each new le is assigned a default name according to the information included in the original le:
Es.: 12JM1234_00001_134PRION_190406_1024.dtl
File extension “.dtl” (data logger)
Cycle start time
Cycle start date
Type of the cycle
Cycle counter (launched)
Sterilizer's serial number
A double click on the le name, will show the window with the le content.
There are two types of visualization:
– reduced - default, shown on le opening;
– extended – click the “Extend view” button to see the details of the sterilization cycle, with all
data omitted in the reduced view.
If the cycle did not completed successfully, the view on opening is the extended one and the reduced view cannot be selected.
To print the displayed le, connect a printer to the PC and click the “Print” button.
File name
Files visualization
File name
To print the le
Extended view
Page 19
15
To avoid having to regularly ll the internal water tank (see Chapter 5 - Instructions for Use), it is possible to connect the sterilizer to an optional external tank that the user will less frequently ll, or to a commercially-available, water purication system with accumulation tank.
With this option, the autoclave automatically activates a pump that lls the internal tank when it reaches the MIN level. Be sure to monitor the external tank as the Bravo unit can not monitor the water level in the external tank.
To connect the external tank, follow the instructions below:
– Install the tap provided on the tank; use Teon tape or connector sealant for a perfect seal.
Clip
Silicon pipe
Teflon
Tap
Clip
Filling tank
– Use the tank’s silicone tube (or other suitable tube) and insert it on the lling connector taking
care to push it completely on.
– Lock the tube to connector with the plastic tie provided.
– Insert the other end of the tube on the tap of the tank.
– Make sure that the tube runs freely from the device to the tank, without being bent, crushed
or obstructed in any way.
– Loosen the cap to facilitate the ow of water.
– Open the tap on the lling tank.
NOTE
refer to the Chapter — Configuring the deviCe - automatiC filling option.
CONNECTING AN EXTERNAL WATER FILLING TANK
(OPTIONAL, automatic filling function)
Page 20
16
Follow the instructions shown below for a correct direct connection to a centralized draining point:
– Insert the silicone tube (provided) or other suitable plastic tube onto hose connection A; push
the tube all the way on and lock with the plastic tie or other means;
– Cut the tube to measure, push the free end on the connection provided on the centralized
draining point and lock with the plastic tie or other means.
NOTE
make sure the tube is not bent, Crushed or obstruCted in any way.
The following diagram provides an indicative arrangement of the components:
NOTE
the ConneCtion point to the Central drain must be lower than the sterilizer's
support surfaCe. otherwise, the tank may not empty CorreCtly.
DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT
Support plane
Pipe
Connector (A)
This point must be at level lower than the sterilizer's support plane
To the centralized draining point
Drain siphon
Clamp
Page 21
17
Once the sterilizer has been correctly installed, it may be turned on and prepared for use.
Turn on the equipment by the main switch located on the right side of the machine.
NOTE
do this with the sterilizer's door open
.
When turned on, the control panel lights up and beeps so you can visually check its correct operation. The panel then displays this message:
Apparatus serial number
Firmware version
BRAVO 17V
R. Exxxx/ JPyyyyy
12 JP 0001
DEVICE CHECK-UP
NOTE
if the door is Closed, the test is interrupted. the panel then beeps and displays the
following message.
OPEN THE DOOR
TO CONTINUE
Open the door to allow the test to continue. At the end of the test you will see:
BRAVO 17V
R. Exxxx/ JPyyyyy
12 JP 0001
CHECK-UP COMPLETE
The sterilizer measures the ambient pressure for the correct operation of several auxiliary devices. Whenever the difference between the value read and that previously stored (see the Chapter 6 — Configuration Acquisition of the ambient pressure) is higher than a set value, the system automatically updates the stored value after a brief delay. Otherwise, the data remains unchanged without updating.
After updating, the device performs the initial automatic test procedure (see above). At the end, the display shows the following message (accompanied by a beep).
AMBIENT PRESSURE
VALUE UPDATED
-0.01 bar
to continue
When is pressed, the device goes to STAND-BY mode (see below).
FIRST START-UP
TURNING ON THE EQUIPMENT
INITIAL AUTOMATIC TEST
ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES
Page 22
18
After the initial test, the sterilizer goes to STAND-BY mode and the display shows:
Counter xxxxx/yyyyy
Stand-by HIGH
23.6 °c 30/08/12
-0.01 bar 18:13:05
The upper line is the cycle counter for sterilizations performed, with the number of correctly completed cycles on the left and the total number started on the right. The line below shows the Stand-by status and the preheating mode (High-Low-Off). The two lower lines show the temperature and pressure of the sterilization chamber on the left and current date and time on the right.
NOTE
a CyCle begins with the start of the sterilization CyCle (first vaCuum phase),
exCluding the preheating phase. a CyCle ends at the end of the program (see the
C
hapter — program exeCution).
t
o set the date and time as well as seleCt the preheating mode, print the data and
fill the tank, please refer to the Chapter, “Configuring the deviCe”.
At regular intervals, the rst two lines on the display alternate with the modes set for printing (ON/OFF) and lling (Manual/Automatic):
Print ON
Filling MANUAL
23.6 °C 01/02/12
-0.01 bar 18:13:05
The icons in the lower part of the LCD screen remain off with the exception of the door status and/or water level indicators, which light-up if the door is closed and/or the level in the lling tank reaches its MIN or MAX values (or the MAX value in the drain tank).
During the rst start-up, the MIN water level icon in the ling tank is normally on.
The device waits for the selection of the desired sterilization program (see the Chapter —
Program Selection).
DANGER
WHEN THE DOOR IS OPEN IN STAND-BY MODE, A BEEP INDICATES THAT THE SURFACES INSIDE THE DEVICE ARE HOT. TO AVOID BURNS, TAKE CARE NOT TO TOUCH THE STERILIZATION CHAMBER, THE SUPPORTS PROVIDED OR THE INSIDE OF THE DOOR WITH YOUR BARE HANDS.
STAND-BY MODE
Page 23
19
The rst time the sterilizer is used, or when the MIN water level indicator comes on, you will have to ll, or top-off, the internal distilled water tank.
Operate as follows (with the machine on) referring to the gure:
1. Remove the rubber cap.
2. Insert the lling funnel provided in the llercap.
3. Slowly pour the distilled water into the funnel until the
MIN icon
goes off.
4. Continue lling with water until reaching the maximum
level in the lling tank, indicated by the MAX icon
coming on accompanied by an acoustic war-
ning.
Immediately stop lling; under no circumstances exceed the MAX limit indicated at the bottom of the llercap.
Be carefulnot to spill any water on the machine, and if so, immediately dry it off.
5. Remove the funnel from the llercap.
6. Ret the rubber cap.
With reference to the gure (and with the door open), follow these steps:
1. Fill the manual container (2 litres/ 0.52 US gal) with
distilled water, keeping it horizontal.
2. Connect the tube’s quick connector to the corresponding
female connector under the chamber entrance (marked
), pushing until you hear a click.
3. Place the container in a vertical position and loosen the
cap and taking care not to spill water on the machine.
4. The water will begin to ow into the tank.
5. Continue lling until the MIN level indicator turns off or
the MAX level indicator turns on.
6. At this point, lower the bottle below the connection
point on the unit, keeping it horizontal.
7. While pinching the tube with your ngers press the metal lever on the side of the connector and
detach the quick connector.
8. Rell the container (2 litres/ 0.52 US gal) and repeat steps 2, 3 and 4 a second time until the MAX
level icon appears on the display.
9. When the MAX level icon comes on (accompanied by a beep), stop lling and detach the quick
connector as described in steps 6 and 7.
NOTE
the iCon max does not have to be on to start a sterilization
program. there is suffiCient water if the min indiCator is off.
do not Continue to fill onCe max iCon appears and you hear a beep. doing so may
Cause water to drain from the unit's water tank draining point at the baCk of the maChine.
FILLING DISTILLED WATER
Manual filling (front side)
Manual filling (top side)
Page 24
20
Automatic filling
When the water level in the internal or external drain tank reaches the MAX level, the LCD display alternatively lights the MAX and MIN icons.
NOTE
at this stage, the unit will generate an alarm indiCation (see appendix e - alarm)
should you attempt to start a sterilization CyCle.
In this case, empty the internal or external draining tank.
To drain the internal tank, follow these steps:
1. Arrange an empty container on the oor near the sterilizer and put the free end of the supplied tube into the container.
2. Connect the quick connector to the corresponding female connector under the chamber entrance (marked ) pushing until you hear a click.
3. Wait for the internal tank to drain completely, then while pinching the tube with your ngers, press the metal lever located on the side of the connector and detach the quick connector.
MAX LEVEL IN THE INTERNAL / EXTERNAL DRAIN TANK
Emptying the used water internal tank
Detaching the pipe
If a unit is set up for automatic lling from an external tank, the lling will occur automatically after this automatic lling option has been selected.
NOTE
use only high quality distilled water. for the speCifiCations of the water supply,
see appendix a (teChniCal CharaCteristiCs).
To set the automatic lling option, please refer to the Chapter — Conguration – Setting the tank lling mode.
WARNING
THE AUTOMATICALLY FILLING SYSTEM MUST NEVER RUN DRY; THIS WILL CAUSE PREMATURE WEAR TO THE AUXILIARY WATER­INJECTION PUMP. PERIODICALLY CHECK THE WATER LEVEL IN THE EXTERNAL TANK.
IF AUXILIARY WATER-INJECTION PUMP RUNS DRY, THIS MAY BE AN INDICATION OF AN EMPTY EXTERNAL WATER TANK, AND THE UNIT WILL DISPLAY A CYCLE FAULT A040. TURN OFF THE POWER TO THE UNIT AND FILL THE EXTERNAL BOTTLE WITH DISTILLED WATER. THEN TURN THE UNIT POWER ON.
Page 25
21
-
+
Bravo users can con gure the device to meet their speci c needs. For example, the device's performance may be adapted on the basis of the type of activity, the type of material to be sterilized or its frequency of use.
The SETUP program allows selecting from several options that users can activate through an easy-to-use menu.
NOTE
use the setup program whenever neCessary. a CorreCtly personalized deviCe
provides the best performanCe and the most satisfaCtory use.
s
CiCan Customer support (see appendix z) is available to help users by providing
suggestions or adviCe on the best way to uses the options in the setup program
To start the SETUP program, hold down the key on the control panel for several seconds, until the display shows:
BRAVO 17V
SETUP
to continue
to exit
NOTE
iCon setup on the display lights-up and stays on or the entire Configuration
phase.
When you press the key, you enter the SETUP. The screen shows the  rst-level menu items (see the paragraph, SETUP fl owchart). Press the ESC key quits the SETUP program and takes you back to normal operation (stand­by mode).
NOTE
the setup program Can only be started in stand-by mode. it is not aCCessible
during sterilization or test CyCles.
In SETUP mode the control panel keys have different functions than in normal mode.
Key SETUP mode function
ENTER key to con rm the selected option or value
+
Increase the value /scroll up
-
-
-
Decrease the value /scroll down
ESC key to exit the selected menu option
Now, we describe the meaning of the various main menu and second-level menu items.
CONFIGURATION
INTRODUCTION
STARTING AND ENTERING THE SETUP MODE
MEANING OF THE KEYS IN SETUP MODE
Page 26
22
Rev. 07 (de l 16/12/2005)
YES
BASIC
ADVANCED
dd/mm/yyyy
+/- to set
to enter
to exit
hh:mm:ss
+/- to set
to enter
to exit
LANGUAGE
DATE SETTING
TIME SETTING
EXIT
HIGH
LOW
OFF
EXIT
PRINT OPTIONS
STAND-BY OPTIO NS
PROGRAMS
FILLING OPTIONS
EXIT
EXTRA: XX min +/- to set
to enter
to exit
AUTOMATIC
MANUAL
EXIT
PRINTER
REPORT
EXIT
NORMAL PRINT
EXTENDED PRINT
EXIT
COPIES: XX +/- to s
et
to enter
to exit
NR. COPIES
PRINT LAST
EXIT
INTERNAL
EXTERNAL
EXIT
134c PROCESS
121c PROCESS
EXIT
TIME: XX min +/- to set
to enter
to exit
4th PRESET
3rd PRESET
2nd PRESET
EXIT
MILLENNIUM B
SETUP LAYOUT
NOTA
2nd LEVEL
MENU’
PRINT
REPORT
NOW PRINTING
THE REPORT
PLEA SE WA IT...
134 SOLID / WRAPPED
121 SOLID / WRAPPED
134 SOLID / WRAPPED
121 SOLID / WRAPPED
134 HOLLOW / UNWRAP.
121 HOLLOW / UNWRAP.
134 EMERGENCY
XXXc CUSTOM
EXIT
SHORT DRYING
LONG DRYING
EXIT
FRA CTIO N. V ACUUM
SINGLE VACUUM
EXIT
STANDARD DRY ING
INTELL. DRYING
EXTRA DRYING
EXIT
STANDARD DRY ING
FAST DRYING
EXIT
NO
SPECIAL
SERVICE
REVIEW
EXIT SETUP
PRESSURE VALU
E
SET INTO MEMO RY
WARNIN G!
OPEN THE DOOR
TO CONT INUE
Is the door
open?
EXIT SETUP (st-by)
or
RESUME SETUP
time
limited
(+ beep)
until door
opening
AMBIENT PRESSURE
EXIT
LCD CONTRAST
Selected progra m (see menu)
STND, I NTEL, EXTRA (long dry ing) STND, F AST (short dry ing)
INTERNAL, EXTERNAL CR , EXTERNAL CR+LF
MANUAL, AU TOMATIC (f illing) INTERNAL, EXTERNAL (drain)
HIGH, LOW, OFF 30 min, … , 300 min (s
tep of 30 m in)
ESPANOL
DEUTSCH
EXIT
ITALIANO
ENGLISH
FRANCAIS
ST-BY TIMEOUT
ST-BY MODE
EXIT
TIMEOUT: XXX min +/- to set
to enter
to exit
CR TYPE
CR+LF TYPE
EXIT
TYPE 1
TYPE 2
EXIT
ACQUISI TION OF THE
AMBIEN T PRESSU RE
to enter
to exit
ADJUSTMEN T OF THE
LCD C ONTRAST
+/- to set to exit
1st PRESET
starting from 01’
CONTINU E
-
(press +/ to scroll )
BRAVO 17V
EXIT SETUP?
to conf irm
to res
ume
Firmware rele ase
Exxxx / JPyyy yyy
Serial Number
ENGLISH
Date
dd/mm/yyy y
Time
hh:mm:ss
1st PRESET
134 POROUS/WRAPPED
STANDARD DRYING
Stand-by option
HIGH
120 min
Print option
EXTERNAL CR+LF
1 copy
Filling option
AUTOMATIC
Drain option
INTERNAL
EXIT
REVIEW
to confirm
2nd PRESET
134 HOLLOW/UNWRAP.
FAST DRYING
3rd PRESET
134 SOLID/WRAPPED EXTRA DRYING (+05)
4th PRESET
134 SOLID/UNWRAP
FAST DRYING
DRAIN OPTIONS
INTERNAL
EXTERNAL
EX
IT
OFF
134 HOLLOW / UNWRAP.
+ 121 HOLLOW / UNWRAP.
sample
visualization
BRAVO
SETUP
to continue
to exit
ONLY AVAILABLE FOR
SCICAN SERVICE
3rd LEVEL
MENU’
TIME: XX min +/- to set
to enter
to exit
starting from 18’
CR TYPE (+FF)
CR+LF TYPE (+FF)
EXIT
DISABLED
ANY CYCL E START
ANY POWER ON
PASSW ORD
INSERT PASSWORD * * * * * * * * * * * * * * *
*
to enter
CONFIRM PASSWORD
* * * * * * * * * * * * * * *
*
to enter
PRINTOUT MODE
AT CYCLE END
STEP BY STEP
EXIT
Quando il comando EXIT è attivato si torna al menù precedente (il tasto ESC sulla tastiera ha lo stesso eetto
del comando EXIT)
Quando un OPZIONE nale
è stata selezionata
(memorizzata) si torna al 2°-3° livello del menu.
BRAVO
Configuration menu diagram:
NOTES
When EXIT (EXIT) is selected, the previous menu
level is restored (the ESC key on the panel has the
same function as the EXIT (EXIT) key).
When the last menu OPTION available is selected
(or when recording is conrmed) the previous menu
level is restored.
Page 27
23
MAIN MENU
The main menu has 6 entries that open additional (second-level) menus:
BASIC (basic options) ADVANCED (advanced options) SPECIAL (special options) SERVICE (menu not accessible to users) DATA REVIEW (summary of options selected) EXIT SETUP (exit the SETUP program and return to normal operation. In this
regard, see the paragraph, Exiting the SETUP program)
BASIC Menu
The Basic menu (basic options) consists of the items:
LANGUAGE (language setting) DATE SETTING (setting the current date) TIME SETTING (setting the current time) PASSWORD (setting the password) EXIT (exit the BASIC menu and return to the main menu)
ADVANCED Menu
The Advanced menu (advanced options) consists of the items:
PROGRAMMES (setting preselected sterilization programs, shown on the LCD
display)
STAND-BY OPTIONS (stand-by mode settings) PRINT OPTIONS (setting printer and printing options) FILLING OPTIONS (setting modes for filling the distilled water tank) DRAIN OPTIONS (setting the modes for emptying the used water tank) EXIT (exit the ADVANCED menu and return to the main menu)
SPECIAL Menu
The Special menu (special options) consists of the following items:
AMBIENT PRESSURE (acquisition of the ambient pressure) LCD CONTRAST (adjusting the contrast of the Liquid Crystal Display) EXIT (exit he SPECIAL menu and return to the main menu)
SERVICE Menu The Service menu can ONLY be accessed by the Service department.
DATA REVIEW Menu
The Data Review displays a summary of the device's current settings, allowing users to verify their correctness.
DESCRIPTION OF THE MENU ITEMS
Page 28
24
It has the following screens (shown by way of example):
BRAVO 17V
R.Exxxx/JPyyyyyy
10 JP 0001
ENGLISH
DATE
dd/mm/yyyy
TIME
hh:mm:ss
Use the keys
+ / - to scroll through the menu
1st PRESET
134 POROUS/WRAPPED
STANDARD DRYING
2nd PRESET
134 HOLLOW/UNWRAP.
FAST DRYING
Use the keys + / - to scroll through the menu
3rd PRESET
134 SOLID/WRAPPED EXTRA DRYING + 05
4th PRESET
134 EMERGENCY
FAST DRYING
Use the keys + / - to scroll through the menu
Stand-by option
HIGH
120 min
Print option
OFF
1 copy (ies)
Use the keys + / - to scroll through the menu
Filling option
AUTOMATIC
Drain option
INTERNAL
Use the keys + / - to scroll through the menu
EXIT
DATA REVIEW
to continue
Press to continue
NOTE
to learn more about any of the terms above, see Chapter — aCtivating - C
onfiguration options.
Page 29
25
The sterilizer leaves the factory with the following settings:
DATE: current date TIME: current time
PROGRAMS: 1° PRESET: 134°C POROUS/WRAPPED
2nd PRESET: 121°C HOLLOW/UNWRAP 3rd PRESET: 134°C SOLID/WRAPPED 4th PRESET: 134°C SOLID/UNWRAP
NOTE
the programs indiCated should be Considered as preferential settings. however,
other Combinations are possible based on the destination market.
ST-BY MODE: HIGH (preheating)
PRINT OPTIONS: INTERNAL (1 copy, with optional printer)
FILLING OPTIONS: MANUAL
DRAIN OPTIONS: INTERNAL
To congure the unit access the SETUP mode from the stand-by screen, enter the SETUP mode by holding down the key on the control panel for several seconds until the SETUP screen appears (shown below).
Counter xxxx/yyyy
Stand-by HIGH
23.6 °C 30/08/02
-0.01 bar 18:13:05
Scroll to the BASIC menu and press the key. From here, scroll and select any of the following conguration options.
Select LANGUAGE using the key. The following screen will appear:
ITALIANO + ENGLISH FRANÇAIS DEUTSCH ­ ESPAÑOL
Select the desired language.
Move using the + or – keys and conrm using the
key to store the selection. After the data is
conrmed, you return to the second-level menu.
NOTE
as soon as the seleCtion is Confirmed, all the menus of the setup program will
be displayed in the language set.
When DATE SETTING is selected with the key, you will see:
dd/mm/yyyy +/- to set
to enter
to exit
DEFAULTS SETTINGS
ACTIVATING CONFIGURATION OPTIONS
Setting the language
(LANGUAGE on the BASIC Menu)
Setting the date
DATE SETTING on the BASIC Menu)
Page 30
26
To set the date, follow these steps: – When the day ashes: set the current date with the + and - keys. Conrm with ↵. When the month ashes: set the current month with the + and - keys. Conrm with ↵. When the year ashes: set the current year with the + and - keys. Conrm with ↵.
The date is stored. Once the last conrmation is given, you return to the second-level menu.
When TIME SETTING is selected with the key, you will see:
hh:mm:ss
+/- to set
to enter to exit
Follow these steps:
When the hours ash: set the current hour with the + and - keys. Conrm with .
When the minutes ash: set the current value with the + and - keys. Conrm with .
When the last conrmation is given, return to the second-level menu.
When PASSWORD is selected with the key, you will see this menu:
DISABLED +
ANY POWER ON ANY CYCLE START EXIT -
Select DISABLED to use the device freely, without any limitation on operator access.
Select ANY POWER-ON to password protect the main power switch. This allows only authorized personnel to turn the unit on. Once it is on, it can be used by any operator.
Select ANY CYCLE START to password protect the unit both at power-on and at the start of every sterilization program. In this mode, only authorized personnel will be able to use it.
NOTE
entering a password provides more Controlled use of the produCt but, at the same
time, inevitably makes it more Cumbersome. so as not to overly CompliCate using the deviCe, we reCommend only aCtivating this option when it is really needed.
When the ANY POWER-ON or ANY CYCLE START options are selected, the following screen is displayed:
INSERT PASSWORD
to enter
to exit
Enter the password with the + and – keys (xed length, 8 characters). Conrm with the key. Then, the following message will appear:
CONFIRM PASSWORD
to enter
to exit
Enter the password again using the + and keys. Conrm with the .key
Setting the time
(TIME SETTING on the BASIC menu)
Setting the password
(PASSWORD on the BASIC menu)
Page 31
27
NOTE
to Change the password, first seleCt the disable option, whiCh CanCels the pre
-
vious password, and then seleCt the any power-on or any CyCle start option, entering the new password as desCribed above.
Setting and storing customized sterilization programs in the four pre-set positions can be completed by following these steps, starting in the advanced menu. Each pre-set position can be associated to a standard or user congurable cycle (CUSTOM).
To associate a standard program and dene several of its parameters, proceed as follows:
1. Select PROGRAMS using the key; the following menu appears:
1stPRESET +
2ndPRESET 3rdPRESET 4thPRESET ­ EXIT
Dene the position (1, 2, 3 or 4) to which the sterilization program will be associated using the + and - keys. Conrm with the key.
2. From here, you enter the list of available cycles:
134 HOLLOW/UNWRAP +
121 HOLLOW/UNWRAP. 134 SOLID/UNWRAP. 121 SOLID/UNWRAP. ­ 134 EMERGENCY 134 SOLID/WRAPPED 121 SOLID/WRAPPED 134 POROUS/WRAPPED 121 POROUS/WRAPPED XXX CUSTOM EXIT
Using the + and - keys, scroll the list until you identify the sterilization program desired.
3. Conrm the selection with the key.
As a function of the choices made, you will go to one of two alternative menus that allow selecting the type of drying to associate to the selected program.
Setting the sterilization programs
(PROGRAMS on the ADVANCED menu)
Page 32
28
a) Programs with short drying (HOLLOW/UNWRAP., SOLID/UNWRAP., EMERGENCY):
STANDARD DRYING + FAST DRYING EXIT
-
It is possible to select STANDARD mode (the default setting) or FAST (reduced drying, recommended for light loads). Move using the + and - keys and conrm with the key.
NOTE
the emergenCy program provides only fast drying (suitable for a load up to
0.5
kg/1.1 lbs).
b) Programs with long drying (POROUS/WRAPPED, SOLID/WRAPPED, EXTRA):
STANDARD DRYING + INTELL. DRYING EXTRA DRYING EXIT -
The default setting is STANDARD. Also available are the INTELLIGENT option, an automatic drying that adjusts its duration on the basis of the volume and/or quantity and type of load, and the EXTRA option, a selectable value extended drying recommended for critical loads. Move using the + and - keys and conrm with the key.
NOTE
with large loads or speCial materials, the standard option may not provide a perfeCt
result. in this Case, extend the drying phase by using the extra mode.
with partiCularly Complex types of loads (suCh as wrapped instruments in a "Container" for
sterilization) "intelligent" drying may not work CorreCtly, with worse than expeCted results.
in these Cases, use the standard or extra options, depending on the need.
WARNING
the fast, intelligent and extra drying options have not been validated and have
not been Cleared in the u.s. by fda for healthCare use.
please refer to the "program summary table" and its general notes (see appendix b — programs) for a desCription of the drying options and the maximum
sterilizable mass allowed in eaCh sterilization program.
When the EXTRA option is activated, the following screen appears:
EXTRA: XX min
+/- to set
to enter to exit
This option permits setting the duration of extra drying from between 1 and 15 minutes (time to be added to the STANDARD DRYING time). Set the value using the + and - keys and conrm the selection with the key.
NOTE
the seleCtion Can be Changed at any time by following the proCedure desCribed
above.
w
henever an identiCal sterilization program is already present in another position, the seleCtion is not aCCepted. the following warning appears on the display, along with a beep:
THIS PROGRAM
IS ALREADY PRESET
Page 33
29
To dene the CUSTOM program. follow these steps:
1. From the PROGRAMS menu, select the number to which the program is to be associated (see the previous description) and then select CUSTOM in the next screen. The following menu will appear:
134°C PROCESS + 121°C PROCESS EXIT
-
Select 121 °C to perform a custom program with a sterilization process at 121 °C or 134 °C for one at 134 °C. Move using the + and - keys and conrm with the key.
2. You will then go the screen:
TIME: XX min
+/- to set
to enter to exit
Use the + and - keys to set the duration of the sterilization process and conrm with the key.
NOTE
the duration of the sterilization proCess is variable from 4 to 30 minutes for the
program at 134 °C, and from 20 to 30 minutes for the program at 121 °C.
3. After selecting the time, you go to the menu where you specify the type of initial vacuum:
FRACTION VACUUM + SINGLE VACUUM EXIT
-
Select FRACTION to perform a fractionated vacuum (for hollow bodies and porous materials), or SINGLE for a single preliminary vacuum phase (for solid instruments). Move using the + and ­keys and conrm with the key.
4. After selecting the vacuum, a new screen will ask you to set the drying mode:
SHORT DRYING + LONG DRYING EXIT
-
Select LONG drying suitable for porous and/or wrapped loads, or SHORT if you need to sterilize solid, loose materials (and even hollow, as long as it is not wrapped). Move with the + and - keys, conrm with the key.
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30
Depending on the selection (SHORT or LONG) one of two different menus will open (these menus are the same for the standard cycles), i.e.:
In SHORT mode the following is displayed:
STANDARD DRYING + FAST DRYING EXIT
-
In LONG mode the following is displayed:
STANDARD DRYING + INTELL. DRYING EXIT
-
NOTE
whenever the Custom program is already present in another position, the se
-
leCtion is not aCCepted. the following warning appears on the display, along with a beep
THIS PROGRAM IS
ALREADY PRESET
WARNING
CUSTOM PROGRAMS HAVE NOT BEEN VALIDATED AND HAVE NOT BEEN CLEARED IN THE U.S. BY FDA FROM HEALTHCARE USE. THEY SHOULD ONLY BE USED BY EXPERIENCED USERS.
PLEASE REFER TO THE "PROGRAM SUMMARY TABLE" AND ITS GENERAL NOTES (SEE APPENDIX B — PROGRAMS) FOR THE LIST OF AVAILABLE PROGRAMS, THEIR SCREENS AND THE CHARACTERISTIMS OF STERILIZABLE MATERIALS (IN RELATION TO THE PROGRAMS).
NOTE
the seleCtion Can be Changed at any time by following the proCedure desCribed
above.
a
CCess to a Custom CyCle does not require a password.
n
one of the Combinations possible in the Customization phase Create any risks or
dangers of injury to the operator or damage to the deviCe.
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31
Based on the equipment's frequency of use, or other considerations, users may want to select a high or low heating level during the STAND-BY (preheating) phase. They may also want to select a STAND-BY time-out mode that determines when the STAND-BY is deactivated. When you select STAND-BY OPTIONS with the key, you access the following menu:
ST-BY MODE + ST-BY TIME-OUT EXIT
-
When you select STAND-BY MODE, an additional menu appears where you can set the heating level:
OFF + LOW HIGH EXIT -
Select HIGH (high preheating level) to reduce the wait time between one cycle and the next.
Select LOW (low preheating) for normal use, since the wait time will be relatively shorter, in any case.
Select OFF (deactivate preheating) for occasional use. In this case, the wait time will be longer (up to about 10-12 minutes for a "cold start"). Move using the + and - keys; conrm with the key.
On the other hand, when the STAND-BY TIME-OUT option is selected, it is possible to set the time for deactivating STAND-BY, i.e., how many minutes after the last cycle the heating elements are turned off. The following screen appears:
TIME-OUT: XX min
+/- to set
to enter to exit
It is possible to set a value between 0 and 300 minutes (in 30-minute increments), after which the heating elements are turned off (a condition analogous to STAND-BY OFF), avoiding the useless consumption of electricity.
Set using the + and - keys; conrm with the
key.
NOTE
this option is also aCtive with stand-by off. however, in this Condition the ti
-
mer value obviously has no effeCt sinCe the heating elements are turned off anyway at the end of the sterilization program.
w
hen any CyCle seleCtion key (sterilization or test) is pressed, or the maChine is
turned off and on with the main switCh, the original stand-by mode (high or
low)
is immediately reaCtivated.
Setting the STAND-BY mode
(STAND-BY OPTIONS on the ADVANCED menu)
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32
The sterilizer can be equipped with an optional printer for recording sterilization program data; it is necessary to set the parameters required for its proper operation.
1. Select PRINT OPTIONS using the key and the following menu appears:
PRINTER + REPORT EXIT
-
Select PRINTER to select the settings for the printer used, or REPORT to set the number of copies to print and to reprint data from the last program executed.
a) Item PRINTER
The following screen appears:
OFF + INTERNAL EXTERNAL EXIT -
Select OFF to deactivate the printing of data at the end of a sterilization (or test) cycle.
Select INTERNAL to enable the thermal printer set inside the front of the sterilizer. In this case, another menu opens:
TYPE 1 + TYPE 2 EXIT
-
Select Type 1 for the model 1 of the printer installed.
Select Type 2 for the model 2 of the printer installed (currently not available).
If, on the other hand, you choose EXTERNAL, the data will be printed on an external peripheral. Following this selection, another menu opens:
CR TYPE + CR+LF TYPE CR(+FF)TYPE CR+LF(+FF)TYPE ­ EXIT -
Activate CR to use printers that advance the paper only on the CR (Carriage Return) command, or CR+LF for that require the CR+LF (Carriage Return + Line Feed) commands, or with +FF (Form-Feed) for printers that require the addition of this command.
NOTE
Consult the printer manual to determine the type of Command used. if this infor
-
mation is not available, try printing with the various options to identify the CorreCt setting.
Setting the printing mode
(PRINT OPTIONS on the ADVANCED menu)
Printer model 1
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33
b) Item REPORT
The following screen appears:
PRINTOUT MODE + NR. COPIES PRINT LAST EXIT -
Select item PRINTOUT MODE to chose the mode the data are printed: the following options appear:
AT CYCLE END + STEP BY STEP EXIT
-
Select AT CYCLE END to print the report al the end of the cycle. Select STEP BY STEP to print the data at each phase of the cycle, as result in the normal printout (see Examples of printed report in Appendix B).
NOTE
in step by step mode is not possible more report Copies.
t
he vaCuum and helix test report print is Carried out only in mode “at CyCle
e
nd”.
Activate NR. COPIES to set the number of copies of the cycle report to print at the end of the program. The following text appears:
COPIES: XX
+/- to set
to enter to exit
Set the number of copies desired (up to a maximum of 5). Conrm with the key.
On the other hand, the selection PRINT LAST reprints the report for the last cycle executed (whether it terminated correctly or was interrupted by an alarm). The following screen appears:
NORMAL PRINT + EXTENDED PRINT EXIT
-
The NORMAL PRINT command activates normal printing (that with salient cycle data produced at the end of a correctly executed cycle), while EXTENDED PRINT activates complete printing (including all the data typical of a cycle interrupted by an alarm).
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34
NOTE
if the last CyCle Completed CorreCtly (or was interrupted by manual stop) it
will be possible to reprint it in either normal or extended mode.
i
f the last CyCle was interrupted by an alarm (manual stop exCluded) it only
the extended mode will be available.
Following the reprint command, this message will be displayed:
NOW PRINTING
THE REPORT
PLEASE WAIT...
which will remain on the screen until printing is nished.
The internal tank can be lled either manually or automatically. Automatic lling would occur from an external device (container or demineralizer) connected to the Bravo - see Chapter ­Installation).
Select FILL OPTIONS and the following menu appears:
AUTOMAT.FILLING + MANUAL FILLING EXIT
-
When AUTOMATIC FILL is selected, the unit will automatically ll the internal tank until the maximum level (MAX signal) is reached and the MAX icon is displayed.
NOTE
only aCtivate the automatiC filling mode after the external tank has been filled
with high quality distilled water or demineralizer. also remember to open the tap on the external tank or demineralizer, if required.
When MANUAL FILL is selected, the internal tank must be lled manually (see the Chapter, “First Start-Up”). Scroll through the items with the + and - keys; conrm with the key.
Setting the tank filling mode
(FILLING OPTIONS on the ADVANCED menu)
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35
Selecting INTERNAL DRAIN enables the reading of the MAX level sensor in the internal tank. This is the setting that should be selected if connected directly to the drain.
Selecting EXTERNAL DRAIN enables the MAX level sensor located in the external tank and in the internal tank.
NOTE
the level sensor in the internal tank remains aCtive in either mode to prevent a
possible malfunCtion of the external tank or a missing or faulty ConneCtion of the optional external drain tank.
i
f the installation has ConneCted direCtly to the drain, seleCt internal drain.
Scroll through the items with the + and - keys; conrm with the key.
The rst time the sterilizer is used and after any reinstallation, the sterilizer must acquire the ambient pressure. This operation is necessary or the correct operation of several of the device's auxiliary systems. When AMBIENT PRESSURE is activated, the following screen appears:
ACQUISITION OF THE
AMBIENT PRESSURE
to enter
to exit
NOTE
CheCk that the sterilizer door is Completely open. if you try to aCquire the pres
-
sure with the door Closed the following message will be displayed:
OPEN THE DOOR
TO CONTINUE
which remains until the door is opened.
Conrm the acquisition of the data by pressing the key. This message appears:
PRESSURE VALUE
SET INTO MEMORY
accompanied by a beep. The ambient data pressure has been acquired.
On the other hand, press the
key to cancel the operation.
Acquisition of the ambient pressure
(AMBIENT PRESSURE on the SPECIAL menu)
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36
The LCD contrast function adjusts the screens’ readability to compensate for the sterilizer location’s lighting.
When LCD CONTRAST is activated, this screen appears:
ADJUSTMENT OF THE
LCD CONTRAST
+/- to set
to exit
Press the + key increases the contrast while the - key decreases it.
Place yourself in your usual working position and adjust the contrast until the display is as clear and readable as possible.
When you have completed the sterilizer conguration, return to the normal mode by selecting EXIT and conrming with the key. – This text will appear on the display:
BRAVO 17V
SETUP COMPLETE
to exit
to resume
After several seconds, the device returns to normal operation in STAND-BY mode.
NOTE
to return to the first level from any Current menu level, just seleCt item exit of
the Current menu and Confirm by
key.
alternatively, you Can press ⇑ (esC) key one or more times.
EXIT THE CONFIGURATION MODE
Adjusting the contrast of the liquid crystal display
(LCD CONTRAST on the SPECIAL menu)
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37
Clean and rinse all instruments before loading them into the sterilizer. Disinfectant residues and solid debris may inhibit sterilization and damage the instruments and the Bravo. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state. If sterile storage is desired, wrap the instruments to be sterilized according to the instrument manufacturer’s instructions, select the appropriate wrapped cycle and allow it to run to completion.
NOTE
user should use only sterilization wraps that have been Cleared for their market. f
or u.s. Customers, use only sterilization wraps that have been Cleared by fda for
the sterilization program Chosen.
To promote drying and enable effective sterilization, wrapped or pouched instruments must not touch each other.
SciCan recommends the nal user carefully choose the most appropriate sterilization cycle according to the recommendations of their leading infection control authorities and local regulatory guidelines / recommendations.
WARNING
PLEASE REFER TO THE APPENDIX B — PROGRAMS (INTRODUCTION) FOR THE LIST OF COMPATIBLE MATERIALS WITH THE STERILIZER.
With regards to textile material (or porous materials in general), such as smocks, napkins, caps and other, carefully wash and then dry these before they are treated in the autoclave.
NOTE
do not use detergents with a high Content of Chlorine and/or phosphates. do
not bleaCh with Chlorine-based produCts. these substanCes Can damage the tray supports, trays and any metal instruments that may be present in the sterilization Chamber.
First of all, it should be recalled that, when handling and managing contaminated material, it is a good idea to take the following precautions:
– Wear rubber gloves of adequate thickness;
– Clean your gloved hands with a germicide detergent;
– Always carry the instruments on a tray;
– Never carry them in your hands;
– Protect your hands from contact with any sharp points or edges; this will avoid the risk of
contracting a dangerous infection;
– Immediately remove any article that does not need to be sterilized or that is not capable of
withstanding the process;
– Carefully wash your still gloved hands when done handling non-sterile material.
All materials and/or instruments to be sterilized must be perfectly clean, without any type of residue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime, etc.).
NOTE
in addition to Causing problems during sterilization, the failure to Clean and remo
-
ve residue Can damage the instruments and/or the sterilizer, itself.
PREPARING THE MATERIAL
INTRODUCTION
TREATING TEXTILE MATERIAL BEFORE STERILIZATION
TREATING THE LOAD BEFORE STERILIZATION
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38
OK
OK
For handles (turbines, contra-angles, etc.), supplement the above with treatment in suitable dedicated devices that provide effective internal cleaning (occasionally including lubrication).
NOTE
the end of the sterilization program, remember to lubriCate the internal handle
meChanisms using the speCial sterile oil. by taking these preCautions, the instru
-
ments useful life will not be reduCed in any way.
WARNING
CONSULT THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF THE INSTRUMENT/MATERIAL TO BE STERILIZED BEFORE SUBJECTING IT TO AUTOCLAVE TREATMENT, CHECKING FOR ANY INCOMPATIBILI­TIES. DILIGENTLY FOLLOW THE METHODS OF USING DETERGENTS OR DISINFECTANTS AND THE USAGE INSTRUCTIONS OF THE AUTOMATIC DEVICES FOR WASHING AND/OR LUBRICATING THEM.
To ensure proper sterilization and to reduce wear on instruments, follow the instructions below:
General notes for positioning on trays:
– Arrange instruments made of different metals (stainless steel, tempered steel, aluminum, etc.)
on different trays or well separated from each other;
– For instruments not made of stainless steel, place a paper sterilization napkin or a muslin cloth
between the tray and the tool, avoiding direct contact between the two different materials;
– Always arrange objects sufciently distant from each other that they will remain so for the
entire sterilization cycle;
– Make sure that all instruments are sterilized in an open position;
– Position cutting instruments, (scissors, scalpels, etc.) so they can not come into contact with
each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and protect them;
– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so avoid
pooling water;
– Do not load trays beyond their indicated limit (see Appendix A);
– Since this value is understood to be the maximum allowed limit, it can be excessive in some
cases, so always use common sense;
– Do not stack trays or put them in direct contact with the walls of the sterilization chamber;
– Always use the tray support provided;
– To insert and extract trays from the sterilization chamber, always use the extractor provided.
NOTE
proCess the appropriate biologiCal/ChemiCal indiCator with every tray to Confirm
sterlization has oCCurred. if proCessing wrapped material, plaCethe indiCator in
-
side on the wrappings.
t
he Customer should use only biologiCal indiCators that have been Cleared in their market. for u.s. Customers, only use biologiCal indiCators that have been Cleared by fda for the sterilization program Chosen.
ARRANGING THE LOAD
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39
OK
OK
OK
Notes for rubber and plastic tubing
– Always rinse before use with pyrogen-free water; do not dry them. – Arrange the tubing on the tray so that their ends are not obstructed or crushed. – Do not bend or wind them, but allow them to lie as straight as possible.
Notes for packets and packages
– Ar≈nge packages side-by-side, suitably spaced and absolutely not piled, to avoid their
coming in contact with the walls of the chamber.
– When it is necessary to wrap particular objects, always use suitably porous material
(sterilization paper, muslin napkins, etc.), closing the wrapping with autoclave adhesive tape.
Notes for wrapped material
– It is best to wrap instruments individually, but if more than one instrument is placed in the
same envelope, make sure that they are made of the same metal.
– Seal the wrapping with adhesive tape designed for autoclaves or heat-sealing machines.
– Do not use staples, pins or other fasteners since they can compromise the maintenance of
sterility.
– Arrange the envelopes to avoid forming air pockets that obstruct the correct penetration and
removal of the steam.
– Orient the envelopes with the plastic side up and the paper side down.
– Always check that envelopes are correctly positioned and turn them over if necessary.
– If possible, place the envelopes on their sides using a suitable support.
– If pouched or wrapped loads are not dry when they are removed from the chamber, the
instruments must be used immediately or resterilized.
WARNING
IF YOU EXPECT TO STORE INSTRUMENTS, ALWAYS WRAP THEM. SEE THE CHAPTER 10 — STORING STERILIZED MATERIAL. THE USER SHOULD USE ONLY STERILIZATION WRAPS THAT HAVE BEEN CLEARED FOR THEIR MARKET. FOR U.S. CUSTOMERS, ONLY USE STERILIZATION WRAPS THAT HAVE BEEN CLEARED BY FDA FOR THE STERILIZATION PROGRAM CHOSEN.
Chemical process monitors suitable for steam sterilizers at the indicated cycle temperatures and times should be included in or on each package or load being sterilized. In addition, SciCan recommends the use of biological monitors such as the EZTEST-STEAM indicator or the 3M Attest system for routine monitoring of the sterilizer. It is important to select the correct biological indicator for the cycle being tested.
STERILIZATION MONITORING
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40
Program selection is key to a successful sterilization process.
Since objects for sterilization can vary in shape, consistency and properties, it is important to identify the most suitable program for it. This will not only preserve its physical characteristics (avoiding or, at any rate, limiting alterations) it will ensure the most effective sterilization.
Power-on the device as described in the Chapter, “First Start-Up”.
NOTE
if a password has been enabled (see the Chapter Configuration - setting the pas-
sword), you will be asked to enter the aCCess Code:
INSERT PASSWORD
to continue
to exit
Enter the password using the + and – keys and con rm with the key.
At this point, the display will not offer any active pre-selection. It is waiting for the user to select a program.
Press the PROGRAM SELECTION key one or more times until you reach the desired program (1, 2, 3 or 4, also shown on the upper left of the display).
NOTE
when the seleCtion key is pressed, the first sterilization program proposed is the
one used for the last CyCle exeCuted
.
The top two lines of the display show the description of the selected program and the type of drying set. Below are the set-point values for the temperature (°C), pressure (bar) and time (mm:ss) of the selected cycle. For example:
1 134 POROUS/WRAPPED
NORMAL DRYING
134.0 °C
2.10 bar
04:00
After a brief interval, the two lower lines of the display will change and show the present temperature and pressure values of the chamber, with the current date and time.
1 134 POROUS/WRAPPED
NORMAL DRYING
101.0 °C
30/08/12
0.01 bar
18:13:05
To cancel the selection, press ESC on the control panel.
PROGRAM SELECTION
INTRODUCTION
PROCEDURE
Page 45
41
NOTE
If no sterIlIzatIon program Is selected, the equIpment cannot start a sterIlIzatIon
cycle, and the followIng message appears on the dIsplay, wIth a beep.
SELECT A PROGRAM
PLEASE...
WARNING
IF YOU USE A PROGRAM THAT IS INAPPROPRIATE FOR THE TYPE OF MATERIAL TO BE STERILIZED (SEE APPENDIX B) THE EFFECTIVENESS OF THE STERILIZATION PROCESS IS NOT GUARANTEED.
Page 46
42
A sterilization cycle consists of a determined number of phases. The number and duration of the phases can differ for the programs, based on the type of air extraction, sterilization process and drying method.
The electronic control system monitors the various phases, while checking that the various parameters are respected. If any type of anomaly is encountered during the cycle, the program is immediately interrupted, an alarm sounds and a code is displayed along with a message explaining the nature of the problem.
After placing the load in the sterilization chamber, select the desired program and close the door until you hear the click.
The door status icon
will  ash to indicate the door is closed.
Press the START button.
NOTE
if a password has been enabled (see the Chapter Configuration - setting the pas-
sword), you will be asked to enter it.
INSERT PASSWORD
to enter
to exit
Enter the password using the + and - keys. Con rm with the key.
The equipment checks the presence of the paper into the on-board printer (if installed). If it is out of paper the following message will be displayed:
WARNING
PAPER OUT
to continue
to exit
Push key to continue however (replace the paper during or at the end of the sterilisation cycle). Push key to return in Stand-by mode.
If the memory is full or has insuf cient space remaining to store the data of the new cycle, the following message will appear:
WARNING
MEMORY FULL
to continue
to exit
RUNNING THE CYCLE
INTRODUCTION
STARTING THE CYCLE
Password check
Printer paper-out check
If the USB key is connected
Page 47
43
Press the key to continue, however, the data recorded on the USB key will be lost. Then download the les onto the PC and cancel the content of the memory (this operation can also be carried out by DataFlash). Reinsert the USB key in its port. Once the operation has been completed, press Start again.
NOTE
the above message is also generated if a non-Compatible usb key is used.
The equipment locks the door.
The door status icon
appears without blinking, the door is locked.
When START is pushed, and for the entire sterilization cycle, the lower lines of the display will show the following parameters:
1 134°C UNIVERSAL
WARMUP
101.9 °C
0.01 bar 00:00
Cycle time is counted from the start of the sterilization cycle (rst vacuum phase), and excludes the preheating phase.
What follows is a phase by phase explanation of the execution of a sterilization cycle, using as an example, the most complete and important cycle, the 134 POROUS/WRAPPED program. This cycle is characterized by a fractionated pre-vacuum.
When the START button is pressed, the rst phase is PREHEATING, which brings the chamber to the required temperature for the start of the cycle. The display shows the following:
1 134°C POROUS/WRAPPED
WARMUP
23.9 °C
0.01 bar 00:00
The icon that shows the status of the sterilization process is off.
PROGRAM EXECUTION
Door locking
Preheating
Pressure of the sterilization chamber (bar)
Temperature of the sterilization chamber (°C)
Progressive time of the sterilization cycle (mm:ss)
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44
When the optimum temperature is reached, the rst vacuum phase (1st VACUUM PULSE) is begins and the unit brings the chamber pressure down to the target value. The display shows:
1 134°C POROUS/WRAPPED
1. VACUUM PULSE
84.1 °C
- 0.69 bar 01:25
When the pre-set vacuum value is reached, steam is injected and the pressure begins to rise (1st PRESSURE PULSE), until the established value is reached.
1 134°C POROUS/WRAPPED
1. PRESSURE PULSE
108.1 °C
- 0.47 bar 03:58
At the end of the pressure rise, the steam, mixed with residual air, is discharged and the second emptying of the sterilization chamber begins (2nd VACUUM PULSE).
1 134°C POROUS/WRAPPED
2. VACUUM PULSE
93.3 °C
- 0.79 bar 06:06
After the second vacuum phase, steam is again injected into the sterilization chamber, with a corresponding rise in pressure (2nd PRESSURE PULSE).
1 134°C POROUS/WRAPPED
2. PRESSURE PULSE
11.4 °C
0.72 bar 07:44
The icon that shows the status of the sterilization process is always off.
At the end of the second pressure rise, there is another discharge and the last vacuum phase begins (3rd VACUUM PULSE).
1 134°C POROUS/WRAPPED
3. VACUUM PULSE
89.9 °C
- 0.70 bar 09:52
First vacuum phase
First rise in pressure
Second vacuum phase
Second rise in pressure
Third vacuum phase
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45
After the last vacuum phase, the pressure in the sterilization chamber must rise to the value set for the sterilization process (3rd PRESSURE PULSE), always through the injection of steam.
1 134°C POROUS/WRAPPED
3. PRESSURE PULSE
128.6 °C
1.70 bar 12:33
When the pressure and temperature values for the selected program have been reached, the unit pauses to allow the temperature in the chamber to stabilize (EQUILIBRATION). The liquid crystal display shows:
1 134°C POROUS/WRAPPED
EQUILIBRATION
135.4 °C
2.15 bar 13:40
When the thermodynamic parameters are balanced, the actual sterilization phase of the materials begins (HOLDING TIME).
With continuous monitoring of the thermodynamic parameters and ongoing management of the plumbing circuit, the pressure and temperature are remain constant within the limits required by the program. A sterilization time countdown begins, and the display shows the following:
1 134°C POROUS/WRAPPED
HOLDING TIME
135.6 °C 04:00
2.16 bar 13:55
The icon for the sterilization process status flashes, to indicate that the treatment of the load is in progress.
At the end of the sterilization phase, the icon
stays on, to indicate the complete sterilization.
WARNING
if the sterilization CyCle is interrupted before Completion, the iCon will Continue to flash. when this happens, the mate­rial Cannot be Considered sterile and must not be used.
At the end of the sterilization phase, the steam is released from the sterilization chamber (STEAM DISCHARGE). The liquid crystal display shows:
1 134°C POROUS/WRAPPED
DEPRESSURIZATION
123.9 °C
1.24 bar 18:20
The icon for the sterilization process status stays on.
Third rise in pressure
Thermodynamic equilibrium
Sterilization time
Steam discharge
Countdown
Page 50
46
After the steam under pressure is released, the vacuum pump turns on to begin the drying phase (DRYING). This creates a low pressure in the sterilization chamber to facilitate the evaporation and consequent elimination of the steam. Depending on the type of drying selected, one of the following screens will appear:
1 134°C POROUS/WRAPPED
DRYING (NOR)
101.1 °C
0.00 bar 18:51
1 134°C POROUS/WRAPPED
DRYING (INT)
101.1 °C
0.00 bar 18:51
1 134°C POROUS/WRAPPED
DRYING (+XX)
101.1 °C
0.00 bar 18:51
When the drying phase is nished, it is followed by a VENTILATION phase in which fresh sterile air is injected, while maintaining a vacuum in the chamber, to eliminate condensate and cool the load.
1 134°C POROUS/WRAPPED
VENTILATION
84.4 °C
-0.77 bar 26:51
At the end of the ventilation phase, the chamber is brought back to atmospheric pressure (LEVELLING) by injecting sterile outside air to allow the opening of the door and the retrieval of the load.
1 134°C POROUS/WRAPPED
LEVELLING
86.9 °C
-0.43 bar 29:21
When the drying cycle is completed and the chamber pressure returns to pre-set safety limits, the door status indicator
will ash, the unit will beep and the door will unlock.
1 134°C POROUS/WRAPPED
CYCLE COMPLETE
86.2 °C
-0.02 bar 29:40
The icon for the sterilization process status is steady on.
Drying
Ventilation
Leveling to the atmospheric pressure
Completion of the cycle
Standard drying
Intelligent drying
EXTRA DRYING (+XX) is the time set
Page 51
47
NOTE
at the end of the CyCle, and up to the opening of the door, the heating elements
are off to allow Cooling of the load. only after the load has been removed will the unit return to any stand-by preheating options you have seleCted..
NOTE
when the sterilizer's' door is not opened at the end of the CyCle, the vaCuum pump
is periodiCally aCtivated to remove any traCes of Condensate from the sterilization Chamber. the display shows:
FORCED VENTILATION
to interrupt
35.2 °C
-0.02 bar 29:40
Press to interrupt ventilation and open the door.
Open the door and retrieve the sterilized material, using the extractor provided.
When the door is opened, the icon
symbol turns off and the device goes to STAND-BY
mode as previously set.
When the door is opened, the report for the sterilization cycle executed is automatically produced (if the printer or data logger is installed). Refer to the print report examples shown in Appendix B, Programs.
If a data logger is installed, never remove the USB stick until the report is fully downloaded, which is indicated by a quick ashing light on the USB stick and a message on the LCD display.
NOTE
if the printout step by step option is seleCted, the report will be printed at the
Completion of eaCh phase of the CyCle.
The device is ready to execute a new cycle. Repeat the procedures explained in the Chapter - Program Selection to execute a new sterilization cycle.
After the cycle is nished, it is important to check the sterilization results.
The report (option) of the sterilization parameters is an additional verication tool.
Open the door
Report print
Equipment ready
RESULT OF THE CYCLE
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48
>3s
It is a good practice to check that the print report issued at the end of the sterilization program, also speci es a positive outcome. At the end of the cycle, the relevant data for the thermodynamic parameters of the sterilization, i.e., temperature and pressure (°C and bar), and time (in minutes) of the sterilization cycle, along with particular attention to the sterilization phase, will print automatically when the door is opened. Check the values on the print report and any additional indications for further con rmation of sterilization. The operator should sign in the space provided and  le the document for possible future use. If necessary, copies of the document can be used to identify the load (or parts of it) with the date/ time of sterilization and details of the type of cycle performed.
To select the number of copies to print, consult Chapter - Con guration.
NOTE
the operator Can also request an extended printout of the sterilization proCess
data, inCluding the reCorded values of all the sensors installed on the maChine. to start this print funCtion, hold down the
(esC) key on the Control panel while
opening the door.
f
or Complete details about printing the summary, please refer to the report examples shown in appendix b, programs.
CHECK OF THE CYCLE DATA REPORT
STORING DATA ON THE USB KEY
MANUAL CYCLE INTERRUPTION
Error code
The operator can manually interrupt the cycle at any time by pressing the START/STOP key for three seconds. The command generates the error E999, because the cycle did not  nish correctly. Until it is safe to open the door, the unit will beep and the display will show:
MANUAL STOP
LEVELLING
101.2°C E999
-0.47 bar 26:01
When safe conditions are reached, the machine activates a special procedure,  rst asking the user to manually unlock the door by displaying the following instruction:
PRESS T O
UNLOCK THE DOOR
86.2°C E999
-0.02 bar 26:01
Press the key to unlock the door.
The following message is then displayed:
MANUAL STOP
OPEN THE DOOR
85.8°C E999
-0.01 bar 26:01
All printing reports can be stored on the supplied USB key so that they can be archived and viewed on the PC whenever necessary (using the DataFlash software).
NOTE
to avoid the possible loss of data stored on the usb key, periodiCally baCkup the
reports.
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49
Finally, when the door is opened, you will be asked to reset the device by the following message:
MANUAL STOP
RESET SYSTEM
85.5 °C E999
-0.01 bar 26:01
To RESET the system, hold down, for at least three seconds, the PROGRAM SELECTION key until you hear the con rming beep.
When the door is opened, the report for the sterilization cycle executed is produced, including the error code (E999). Check the report, initial it in the space provided and  le it in a suitable place. Refer to the print report examples shown in Appendix B, Programs.
After the RESET, the device goes to STAND-BY mode, ready to execute a new program.
NOTE
whenever an alarm is generated in Certain phases of the CyCle, an automatiC pro-
Cedure is aCtivated to Clean the plumbing CirCuit. for a Complete desCription of the alarms, see appendix e “alarms”.
NOTE
after an aborted CyCle, due to blaCk-out or a power failure, the user Cannot
aCCess the Chamber until to the power returns.
a
t that time, the user must reset the unit aCCording to the proCedure desCribed in
the appendix e — alarms (alarm intervention).
a
t the start of the next CyCle, an automatiC proCedure is aCtivated to Clean the
plumbing CirCuit. for a Complete desCription of the alarms, see appendix e —
a
larms.
WARNING
IF THE ICON IS OFF, THE MATERIAL IN THE STERILIZATION CHAMBER CANNNOT BE CONSIDERED STERILE AND MUST NOT BE USED.
>3s
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50
The sterilized material must be adequately treated and stored to maintain its sterility over time, until its use.
Inadequate storage can cause rapid recontamination.
This leads to problems regardless of what you do since you will either be using recontaminated material (most of the time unconsciously), placing the user and patient at risk, or you will have to run the sterilization cycle again, with an inevitable waste of time and resources.
For this reason, we think it will be useful to provide several basic suggestions, leaving the operator the task of further study of specic texts.
Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the following precautions should be taken when handling and/or carrying sterile material:
1. Remove the load from the sterilization chamber wearing gloves and a clean, or even better, sterilized smock. As an additional precaution, wear a protective mask on your face;
2. Rest the tray on a dry, suitably clean and disinfected surface. Take care to distance or, at any rate, separate the sterile material from the area where contaminated material is kept waiting to be sterilized;
3. Touch the material and/or instruments as little as possible, taking extreme care not to cut or damage the wrappings;
4. Let the instruments cool before any transport (and subsequent storage). If necessary for transport, transfer the material using dry, clean and disinfected containers. The containers must be closed or, if open, covered with clean cloths.
Sterile material waiting for used must be stored using the appropriate techniques. These will signicantly slow recontamination:
1. Store the material and/or instruments in the protective wrappings that were used during sterilization. Do not wrap the instruments after sterilization since, in addition to being useless and completely senseless, is also potentially damaging;
2. Store the material in a dry, suitably clean and disinfected place, far from the area where infected material passes. If possible, use closed compartments equipped with ultraviolet light;
3. Identify the sterile material by attaching the sterilization data (attaching a copy of the printed report or an adhesive label);
4. First use the material that has been stored the longest (FIFO, "First In First Out"). This results in material that is homogeneously stored, avoiding storing for too long, with the consequent risks.
5. Never store material for too long. In fact, do not overlook the fact that materials will tend to degrade and be recontaminated in a nite time, even when the above instructions are followed.
NOTE
unpaCkaged instruments and materials must be stored in a Closed, dry, Cle
-
an and disinfeCted plaCe, possibly equipped with ultraviolet light.
p
lease remember that unpaCkaged instruments and/or materials are not suitable
for long time storage.
i
t is reCommended their immediate use after the sterilization proCess.
WARNING
CONSULT THE SPECIFICATIONS PROVIDED BY THE MANUFACTURER OF THE PACKAGING MATERIAL FOR INFORMATION ON THE MAXIMUM ALLOWED STORAGE TIME.
STORING STERILIZED MATERIALS
INTRODUCTION
HANDLING
STORAGE
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51
To protect the safety of users and patients, a fundamental process like sterilizing medical devices should be periodically checked.
In this regard, Bravo offers the possibility of, simply and automatically, executing two distinct test programs:
• Helix/BD Test
• Vacuum Test
The HELIX/BD Test program executes a cycle at 134 °C for a duration of 3.5 min. The cycle has a fractionated vacuum phase similar to that used in the POROUS and HOLLOW programs. Using a suitable device, it is possible to evaluate the correct penetration of the steam inside hollow loads (see the following paragraph). This cycle is also suitable for measuring the penetration of the steam inside porous loads (Bowie & Dick test pack).
On the other hand, the Vacuum Test program tests the seals of the sterilizer's entire plumbing system. By measuring the variation in the degree of vacuum in a certain span of time and comparing it with pre-set limit values, it is possible to determine the effectiveness of the seal of the sterilization chamber, the various tubes and the cut-off devices.
To select the HELIX/BD Test program, press the Test Selection key one or two times until the display reads:
HELIX/BD TEST
134.0 °C
2.15 bar 03:30
The test device (in accordance with the requirements of standard EN 867-5) is a 1.5-m tube made of PTFE with an internal diameter of 2 mm, with a small sealed screw capsule attached to one end, capable of holding a suitable amount of chemical. The other end of the tube is left free to allow the penetration of the steam and evaluate its effectiveness.
To execute the test (in reference to standard EN 13060) insert the chemical indicator, which consists of a strip of paper with a special reagent ink, inside the capsule of the device (which is always to be used perfectly dry). Tighten the capsule so that seepage through the gasket seal will not be possible.
NOTE
the deviCe and ChemiCal indiCators for running the helix/bd test program are not
supplied with the deviCe. to request information in this regard, ContaCt sCiCan's
C
ustomer support department (see appendix g).
Place the device on the device's central tray, approximately in the middle. Do not put any other material inside the chamber.
Close the door and start the program with the START key.
NOTE
if a password has been set with the any CyCle start option (see the Chapter, C
onfiguration, setting the password), you will be asked to enter the aCCess Code.
i
n addition, the equipment CheCks the printer paper presenCe (optional).
t
he possible warning messages, and the Consequent aCtions to Carry out, are the
same as desCribed for a standard sterilization CyCle.
TEST PROGRAMS
INTRODUCTION
HELIX/BD TEST
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52
The cycle phases are analogous to what is described in the Chapter, “Running a Sterilization Program”. At the end of the program, remove the test device, open the capsule and remove the indicator from its housing. If the steam has correctly penetrated, the ink will have completely changed color from what it was before, along the entire length of the strip; if not (insuf cient penetration) there will be only a partial variation or none at all.
NOTE
normally the Color Change is from a light Color (beige, yellow, etC.) to a dark
Color (blue, violet or blaCk). in any Case, diligently follow the instruCtions provi- ded by the indiCator's manufaCturer for its methods of use and indiCation and any other teChniCal details.
As the door is opened at the end of the cycle, a report will be printed of the relevant data for the test cycle performed. Attach the chemical indicator in the space provided, initial the document and  le it in a suitable place.
NOTE
when a usb key is inserted, it is always possible to eleCtroniCally baCkup the
printing reports.
For complete details about printing summaries, please refer to the report examples shown in
Appendix B, Programs.
To select the VACUUM TEST program, press the Test Selection key one or two times until the display reads:
VACUUM TEST
-0.80 bar
The Vacuum Test program is run with the sterilization chamber empty, except for the trays and their supports.
NOTE
run the vaCuum test as the first CyCle after powering-on the equipment.
To avoid the heating of the sterilization chamber in uencing the variation of the vacuum value measured during the Vacuum Test, the system is programmed to prevent running this test when the temperature sensors of the sterilization chamber and steam generator show a value higher than 50° C. If you try to start the program with a higher temperature than indicated above, the liquid crystal display will read:
WARNING!
PT OVERHEATING
-0.80 bar
After a short time, the device will automatically return to STAND-BY mode, ready for use.
VACUUM TEST
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53
NOTE
to rapidly lower the temperature of the Chamber and, thus, perform the vaCuum t
est, switCh off the sterilizer with the door open until the CorreCt temperature
is reaChed.
Close the door and start the program with the START key.
NOTE
if a password has been set with the any CyCle start option (see the Chapter, C
onfiguration, setting the password), you will be asked to enter the aCCess Code.
i
n addition, the equipment CheCks the printer paper presenCe (option) and, if a data
reCorder is ConneCted, the presenCe of the flash Card and its memory CapaCity.
t
he possible warning messages, and the Consequent aCtions to Carry out, are the
same as desCribed for a standard sterilization CyCle.
The vacuum phase begins immediately and the display reads:
VACUUM TEST
VACUUM PULSE
-0.69 bar 01:02
The display shows the pressure (bar), and the total time from the start of the program.
When the pre-set pressure is reached (-0.80 bar) the pump stops and the pressure stabilization phase begins (WAITING PERIOD). This lasts 5 minutes and (shown on the display as a scalar value):
VACUUM TEST
WAITING PERIOD
5:00
-0.80 bar 00:48
During this phase, a variation of not more than 10% of the maximum low pressure is allowed. Beyond this, the test will fail.
When the waiting phase is complete, the pressure verication phase begins (LEAKAGE PERIOD). This will last 16 minutes.
VACUUM TEST
LEAKAGE PERIOD
16:00
-0.79 bar 06:48
In this phase, a variation of up to ±0.02 bar is allowed, compared to the initial phase value. Higher variations cause the test to fail.
This time is counted down until the phase is completed, after which the pressure is brought back to atmospheric pressure.
VACUUM TEST
LEVELLING
-0.29 bar 17:19
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54
When the program nishes, the display will read:
VACUUM TEST TEST PASSED
-0.01 bar 17:44
NOTE
if the pressure Change exCeeds the pre-set limit, the program is interrupted and
alarm message is generated.
s
ee a Complete desCription of the alarms in appendix e.
When the door is opened at the end of the program, a report of the test cycle is printed (if the printer is installed) with all the relevant data.
NOTE
when a usb key is inserted, it is always possible to eleCtroniCally baCkup the
printing reports.
For complete details about printed reports, please refer to the examples shown in Appendix B, Programs.
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55
APPENDIX A TECHNICAL CHARACTERISTICS
SUMMARY TABLE
Device Steam Sterilizer
Classication (according to the Directive 93/42/EEC and subsequent changes)
II b
Model
BRAVO 17 BRAVO 17V BRAVO 21V
Manufacturer
SciCan Ltd.
1440 Don Mills Road Toronto, ON M3B 3P9
CANADA
Phone: (416) 445-1600
Fax: (416) 445-2727
Toll free: 1-800-667-7733
Power supply voltage 120V 220V - 230V 220V - 240V
Frequency 50/60 Hz (depending on the version)
Mains fuses
(6.3 x 32 mm)
F 15A
On-board fuses
(5 x 20 mm)
F1 (Secondary trafo):
F2 (Primary trafo):
F3 (doorlock accidental activation):
F4 (doorlock overload):
F1 PTR (printer protection):
T 5A 250V
T 4A 250V
F 200mA 250V
F 1.25A 250V
T 5A 250V
T 5A 250V
TT 2A 250V
F 200mA 250V
F 1.25A 250V
T 5A 250V External dimensions (HxWxD) (excluding rear connections)
420 x 480x 560 mm 420 x 480x 660 mm
Nominal power 1700 W (15A) 2300 W (10A) Insulation class Class I Installation category Cat. II Environment of use Internal use Sound power level (A weighted) < 65 db(A)
Environmental operating conditions
Temperature: +15 °C ÷ +40 °C Relative humidity: max 80%, non-condensing Altitude: max 3000 m (a.s.l.)
Net weight:
empty empty with trays and support empty, with trays and supports and water at MAX level
~ 50 kg / 110 lbs ~ 55 kg / 121 lbs ~ 58 kg / 130 lbs
~ 53 kg / 117 lbs ~ 58 kg / 128 lbs ~ 62 kg / 137 lbs
~ 58 kg / 128 lbs ~ 63 kg / 139 lbs ~ 67 kg / 148 lbs
Sterilization chamber dimensions
(Ø x D)
250 x 350 mm 250 x 450 mm
Sterilization chamber total volume about 17 l (0.017 m
3
) about 22 l (0.022 m3)
Sterilization chamber useful volume
(with tray supports inserted)
about 10 l (0.010 m
3
)
about 13 l (0.013 m
3
)
Distilled water tank capacity
(supply)
about 4.6 l (water at MAX level) about 0.8 l (water at MIN level)
Sterilization programs
Available: 11 (see Appendix B) Pre-sets: 4 (direct selection by user)
Test programs
Helix / BD Test
Vacuum Test
Preheating time
(from cold)
about 10 minutes
USB connection Standard female connector
Bacteriological lter
(PTFE filtering element)
Porosity: 0.2 μm Connection: male 1/8" NPT connector
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56
SAFETY DEVICES
The sterilizer is equipped with the following safety devices:
– Mains fuses (see summary table data).
Protects inside the device against a fault in the heating elements. Action: cuts the electricity.
– Fuses protecting the electronic circuits (see summary table data).
Protects against a fault in the primary transformer circuit and low voltage uses. Action: cuts power to one or more low-voltage circuits.
– Thermal circuit breakers on the mains voltage windings.
Protects against overheating of the vacuum pump motor and the primary transformer windings. Action: temporary cut-off (until cooling) of the winding.
– Safety valve.
Protects against overpressure in the sterilization chamber. Action: releases the steam and restores to a safe pressure.
– Steam generator manual re-arm safety thermostat.
Protects against steam generator overheating. Action: cuts-off the electricity to the steam generator.
– Heating element manual re-arm safety thermostat.
Protects against overheating of the heating elements of the container under pressure. Action: cuts-off the electricity to the chamber heating element.
– Door position safety microswitch.
Conrms the door is correctly closed when the container is under pressure. Action: signals incorrect door position.
– Mechanized door lock mechanism with electromechanical protection (pressure switch).
Protects against accidental opening of the door (even in a blackout). Action: locks the door.
– Door lock mechanism safety microswitch.
Conrms the door lock is operating correctly. Action: signals the failure or incorrect operation of the door lock mechanism.
– Self-leveling plumbing system.
Plumbing system structure that allows for the spontaneous leveling of pressure in the case of a manual interruption of the cycle, alarm or blackout. Action: automatically restores atmospheric pressure in the sterilization chamber.
– Integrated system for evaluating the sterilization process.
Provides continuous verication of the sterilization process parameters entirely managed by microprocessor. Action: in case of anomaly, immediately interrupts the program and generates alarms.
– Monitoring of the sterilizer's operation.
Provides real-time oversight of all signicant parameters when the machine is on. Action: in case of anomaly, generates alarm messages with possible interruption of the cycle.
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57
WATER SUPPLY CHARACTERISTICS
DESCRIPTION WATER SUPPLY VALUES
VALUES IN
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/l
SILICON OXIDE SiO
2
< 1 mg/l < 0.1 mg/l
IRON < 0.2 mg/l < 0.1 mg/l
CADMIUM < 0.005 mg/l < 0.005 mg/l
LEAD < 0.05 mg/l < 0.05 mg/l
HEAVY METAL RESIDUES (except iron, cadmium and lead)
< 0.1 mg/l < 0.1 mg/l
CHLORINES < 2 mg/l < 0.1 mg/l
PHOSPHATES < 0.5 mg/l < 0.1 mg/l
CONDUCTIVITY AT 20 °C < 15 ms/cm < 3 ms/cm
pH VALUE 5 - 7 5 - 7
APPEARANCE
colorless, transparent,
without sediments
colorless, transparent,
without sediments
HARDNESS < 0.02 mmol/l < 0.02 mmol/l
NOTE
when purChasing distilled water, always CheCk that the quality and CharaCteristiCs deClared by the produCer are
Compatible with those shown in the table.
WARNING
THE USE OF WATER FOR GENERATING STEAM CONTAINING CONTAMINANTS IN LEVELS EXCEEDING THOSE SHOWN IN THE TABLE WILL SIGNIFICANTLY SHORTEN THE STERILIZER’S LIFE. IN ADDITION, THIS MAY INCREASE THE OXIDATION OF MORE SENSITIVE MATERIALS AND INCREASE LIME RESIDUES ON THE GENERATOR, BOILER, INTERNAL SUPPORTS AND INSTRUMENTS.
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58
APPENDIX B – PROGRAMS
INTRODUCTION
The steam sterilizer is appropriate for almost all materials and instruments, so long as they are able to tolerate, without damage, a minimum temperature of 121 °C.
The following material can normally be sterilized with steam:
– Stainless steel surgical/generic instruments;
– Carbon steel surgical/generic instruments;
– Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (counter-angles,
tooth scalers);
– Glass articles;
– Mineral-based articles;
– Articles made of heat-resistant plastic;
– Articles made of heat-resistant rubber;
– Heat-resistant textiles;
– Medication materials (gauze, pads, etc.);
– Other generic material suitable for autoclave treatment.
NOTE
to prevent the instruments and/or matterials from eleCtrolythiC Corrosion during the sterilization
proCess, please avoid direCt ContaCt between the following metals.
aluminum (al) - niCkel (ni); Carbon steel – niCkel (ni); niCkel (ni) – Chrome (Cr); Copper (Cu) – aluminum (al); Carbon steel – Copper (Cu); Chrome (Cr) – Copper (Cu); stainless steel – aluminum (al); Carbon steel – stainless steel; Chrome (Cr) – stainless steel.
always separate the instruments and/or materials by metal type and eleCtrolythiC Compatibility.
NOTE
depending on the Conformation of the material (solid, hollow or porous), any paCkaging (paper/
plastiC envelope, sterilization paper, Container, muslin napkin, etC.) and its heat-resistanCe, it is important that you Choose the appropriate program by referring to the table shown on the next page.
WARNING
THE DEVICE MAY NOT BE USED FOR STERILIZATION OF FLUIDS, LIQUIDS OR PHARMACEUTICAL PRODUCTS.
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59
PROGRAM SUMMARY TABLE
PROGRAM
DESCRIPTION
NOMINAL VALUES
BASIC PROGRAM
PARAMETERS
STERILIZABLE MATERIAL
NOTES
Temperature
(°C)
Pressure
(bar)
Holding time
(min)
Cycle type
(EN 13060: 2009)
Pre-vacuum
(F=fractionated; S=single)
Standard drying
(L=long; S=short)
Total cycle time
(average load ÷
max load)
Average
consumption
H
2
O
(ml/cycle)
Average energy
consumption (kWh/cycle)
TYPE
MAX TOTAL MASS
(kg)
MAX MASS
PER TRAY (kg)
MAX MASS
PER ARTICLE (kg)
220V
17/17V
21V
17/17V
21V
17/17V
21V
17
17V
21V
134 POROUS/ WRAPPED
134 2,10 4 B F L 43 38 43 525 675 0,8
Porous, unpackaged material
1.00 1,25 0.30 0,40 0,30
For material and
instruments in
(single and double)
packaging, we
recommend
using the 3-tray
conguration
(turning 90° the tray
support)
Porous material in single package
0.75 1,00 0.25 0,30 0,25
Porous material in double package
0.60 0,75 0.20 0,25 0,20
Solid material/ handpiences in single package
3.00 4,00 1.00 1,25 0,25
Solid material/ handpieces in double package
1.50 2,00 0.50 0,60 0,25
121 POROUS/ WRAPPED
121 1,10 20 B F L 58 53 58 550 700 0,8
Porous, unpackaged material
1.00 1,25 0.30 0,40 0,30
Porous material in single package
0.75 1,00 0.25 0,30 0,25
Porous material in double package
0.60 0,75 0.20 0,25 0,20
Hollow instruments in single package
3.00 4,00 1.00 1,25 0,25
Solid and hollow instruments in double package
1.50 2,00 0.50 0,60 0,25
134 HOLLOW/ UNWRAPPED
134 2,10 4 S F S 38 31 36 525 625 0,7
Unpackaged hollow handpieces
6.00 7,50 1.20 1,50 0,50
121 HOLLOW/ UNWRAPPED
121 1,10 20 S F S 53 46 51 550 700 0,7
Unpackaged hollow handpieces
6.00 7,50 1.20 1,50 0,50
134 SOLID/ WRAPPED
134 2,10 4 S S L 32 26 30 300 375 0,6
Solid material in single package
3.00 4,00 1.00 1,25 0,25
We recommend using the 3-tray
conguration
(turning 90° the tray
support)
121 SOLID/ WRAPPED
121 1,10 20 S S L 47 41 45 325 400 0,6
Solid material in single package
3.00 4,00 1.00 1,25 0,25
134 SOLID/ UNWRAP.
134 2,10 4 N S S 24 21 25 300 375 0,5
Unpackaged solid material
6.00 7,50 1.20 1,50 0,50
121 SOLID/ UNWRAP.
121 1,10 20 N S S 39 36 41 325 400 0,5
Unpackaged solid material
6.00 7,50 1.20 1,50 0,50
134 EMERGENCY 134 2,10 3 N S
Fast
16 12 14 300 375 0,45
Unpackaged solid material
0.50 0,50 0.50 0,50 0,50
XXX USER
(see note)
134
or
121
2.10 or
1.10
> 4
or
> 20
n.d. F/S L/S n.d. n.d. n.d. n.d. n.d. n.d.
Unpackaged solid material
n.d. n.d. n.d. n.d. n.d.
Variable parameters
depending on the
settings made
HELIX/BD TEST 134 2,10 3,5 - F S 22 20 22 - - -
Test device only
(no other load)
- - - - -
VACUUM TEST - -0,80 - - - - 22 18 18 - - - Empty chamber - - - - -
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60
GENERAL NOTES
1) fraCtionated = pre-vaCuum stage Completed with a sequenCe of 3 vaCuum pulses + 3 pressure pulses. “fraCtionated vaCuumprograms are dediCated to the sterilization of porous materials or handpieCes.
single = pre-vaCuum stage Completed by 1 vaCuum + 1 pressure pulse. “single vaCuumprograms are dediCated to the sterilization of solid materials.
2) l
ong = drying stage for porous material and/or handpieCes and/or solid material in single/double paCkage.
the validated long drying time (standard option) is 16.5 min.
the extra and intelligent options have not been validated.
short = typiCal of hollow and solid CyCles. the validated short drying time (standard option) is 7 min.
the fast option, with a drying time of 2.5 min (up to a load of 1.0 kg max) has not been validated.
3) t
he total CyCle time indiCates the approximate time required for the Completion of the entire program. it does not inClude warm up phase initiated when the start button is pressed. times are dependant on input voltage and load Condition.
4) the program 121°C / 134°C Custom has holding times of 20 minutes (or more) and 4 minutes (or more)
respeCtively at 121°C and 134°C.
pre-vaCuum type and drying type Can be set aCCording to the indiCations given in the notes (1) and (2) above.
the 121°C / 134°C Custom programs have not been validated.
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61
PROGRAM 134
°C POROUS/WRAPPED
134°C FOR 4 MINUTES
Pressure (bar)
0.00
1.00
2.00
2.10
-0.80
Time (min)
LONG DRYING
PROCESS
PRE-VACUUM
OR 134
°C 18 MIN. EXT.
134°C FOR 18 MINUTES
0.00
1.00
1.10
Pressure (bar)
Time (min)
LONG DRYING
PROCESS
FRACTIONATED PRE-VACUUM
PROGRAM 121°C POROUS/WRAPPED 121°C FOR 20 MINUTES
-0.80
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62
PROGRAM 134 HOLLOW/UNWRAP. 134°C FOR 4 MINUTES
Pressure (bar)
0.00
1.00
2.00
2.10
-1.00
Time (min)
SHORT DRYING
PROCESS
FRACTIONATED PRE-VACUUM
-0.80
PROGRAM 121 HOLLOW/UNWRAP. 121°C FOR 20 MINUTES
0.00
1.00
-1.00
Time (min)
SHORT DRYING
PROCESS
PRE-VACUUM
1.10
Pressure (bar)
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63
PROGRAM 134 SOLID/WRAPPED 134°C FOR 4 MINUTES
Pressure (bar)
0.00
1.00
2.00
2.10
-1.00
Time (min)
LONG DRYING
PROCESS
ONE SHOT PRE- VACUUM
PROGRAM
121 SOLID/WRAPPED
121°C FOR 20 MINUTES
Pressure (bar)
0.00
1.00
1.10
-1.00
Time (min)
LONG DRYING
PROCESS
ONE SHOT PRE-VACUUM
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64
PROGRAM 134 SOLID/UNWRAP. 134°C FOR 4 MINUTES
Pressure (bar)
0.00
1.00
2.00
2.10
-1.00
Time (min)
SHORT DRYI NG
PROCESS
ONE SHOT PRE-VACUUM
PROGRAM 121 SOLID/UNWRAP. 121°C FOR 20 MINUTES
Pressure (bar)
0.00
1.00
-1.00
Time (min)
SHORT DRYING
PROCESS
ONE SHOT PRE-VACUUM
1.10
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65
PROGRAM 134 EMERGENCY 134°C FOR 3 MINUTES
Pressure (bar)
0.00
1.00
2.00
2.10
-1.00
Time (min)
DRYING
PROCESS
ONE SHOT PRE-VACUUM
PROGRAM XXX CUSTOM
134°C FOR 4 to 30 MINUTES 121°C FOR 20 to 30 MINUTES
0.00
-1.00
Time (min)
Pressure (bar)
2.10
2.00
1.10
1.00
SETUP
ONE SHOT PRE-VACUUM
or
FRACIONATED PRE-VACUUM
SETUP
Temperature: 134° C 21° C
Time: 4
-
30 MINUTES (134°C)
20 - 30 MINUTES (121°C)
SETUP
LONG DRYING
or
SHORT DRYING
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66
DIAGRAMS OF THE TEST PROGRAMMES
PROGRAM HELIX / BOWIE & DICK TEST 134°C FOR 3 MINUTES
Pressure (bar)
2.10
2.00
1.00
- 1.00
Time (min)
SHORT DRYING
PROCESS
FRACTIONATED PRE-VACUUM
0.00
0.00
PROGRAM VACUUM TEST (VT)
-0.80 bar
Pressure (bar)
P
0
1.00
0.00
Time (min)
-0.80
t1
P1
P2
P3
t2 = t1+300 s
5 minutes 16 minutes
WAITING LEAKAGE
End condition for positive test result
Intermediate condition for the continuation of the test
(P2-P1) < (P0-P1) /10
(P3-P2) < 0.02 bar
t3 = t2+600 s
VACUUM
PHASE
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67
EXAMPLES OF PRINTED REPORTS
Cycle Report (normal)
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0007/0015 Selection 134 °C SOLID/UNWRAPPED Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by LOW Pre-vacuum SINGLE Drying FAST
CYCLE START 01/02/11 12:14
Time C bar
---------------------------------------------------------­00:01 CS 079.4 +0.00 02:02 1PV 093.7 -0.80 05:48 ET 135.6 +2.15 06:02 SS 135.9 +2.17 07:02 135.6 +2.14 08:02 135.5 +2.14 09:02 135.4 +2.14 10:02 SE 135.5 +2.15 10:37 DS 104.1 +0.00 11:41 SPD 047.5 -0.90 16:08 DE 047.6 -0.84 17:12 CE 084.6 -0.04
06:32 MAX 136.0 09:59 MIN 135.4
Drying PuIses 01 CYCLE END 01/02/11 12:36
STERILIZATION: POSITIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
----------------------------------------------------------
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0007/0015 Selection 134 °C POROUS/WRAPPED Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIONATED Drying STANDARD
CYCLE START 01/02/10 09:52
Time C bar
---------------------------------------------------------­00:01 CS 075.1 -0.00 01:57 1PV 047.S -0.80 04:53 1PP 120.5 +1.00 07:00 2PV 061.1 -0.80 09:15 2PP 120.4 +0.98 11:22 3PV 061.1 -0.80 15:04 ET 135.5 +2.15 15:19 SS 135.9 +2.17 16:19 135.4 +2.14 17:18 135.5 +2.15 18:19 135.4 +2.14 19:19 SE 135.5 +2.15 19:53 DS 104.4 +0.00 20:57 SPD 048.4 -0.90 26:55 EPD 094.9 -0.86 29:15 DE 112.6 -0.47 29:43 CE 115.8 -0.04
16:20 MAX 135.9 18:11 MIN 135.4
Drying Pulses 05 CYCLE END 01/02/11 10:28
STERILIZATION: POSITIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cycle Report (extended)
at the operator’s request
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0007/001 Selection 134 °C POROUS/WRAPPED Temperature 134 °C Pressure 2.10 Bar Process t ime 4 min Stand-by HIGH Pre-vacuum FRACTIONATED Drying STANDARD
CYCLE START 01/02/11 09:52
Time T1 P T2 T3 T4
----------------------------------------------------------------
--­00:01 CS 075.1 -0.00 130.9 115.2 093.4 00:11 074.9 -0.28 133.3 114.2 094.0 00:21 074.4 -0.46 146.3 113.2 094.5 00:31 074.3 -0.57 152.6 112.2 095.0 00:35 .. 074.3 -0.59 154.2 111.9 095.2 00:51 .. 078.9 -0.62 152.2 110.4 095.6 01:01 .. 074.9 -0.73 146.6 109.6 095.7 01:27 .. 047.8 -0.78 149.3 107.7 095.7 01:57 .. 047.8 -0.80 155.3 105.8 095.4 02:07 .. 076.5 -0.57 149.9 105.2 095.1 02:17 .. 081.1 -0.49 142.1 104.6 094.6 …………… …………… 08:15 … 068.4 -0.76 151.8 104.7 102.3 08:22 … 061.1 -0.80 153.6 104.5 101.7
08:32 ... 097.4 +0.01 154.7 104.0 100.8 08:42 … 104.6 +0.24 148.9 103.7 101.0 …………… …………… 15:04 … 135.5 +2.15 143.3 111.7 131.7
15:19 … 135.9 +2.17 148.5 113.5 132.6 15:28 … 135.3 +2.16 153.6 115.9 133.0 …………… …………… 19:19 … 135.5 +2.15 157.4 126.5 132.5
19:34 … 134.4 +1.07 157.0 126.8 131.2 19:49 … 108.3 +0.25 156.4 126.8 119.9 19:53 .. 104.4 +0.00 156.1 126.6 116.2
20:04 … 094.2 - 0.50 155.1 125.9 112.4 20:19 … 069.2 -0.73 153.7 124.5 112.9 20:34 … 059.2 -0.81 152.3 123.4 113.5 20:49 … 053.8 -0.87 151.2 122.9 113.6 20:57 … 048.4 -0.90 150.9 122.7 113.5
21:04 … 047.1 -0.80 151.0 122.5 113.5 23:31 … 042.3 -0.89 153.3 122.0 112.2 …………… …………… 26:55 … 094.9 -0.90 153.3 121.7 112.3
27:10 … 101.4 -0.67 154.0 121.7 112.3 27:25 … 105.4 -0.57 153.7 121.5 112.3 …………… …………… 29:15 … 112.6 -0.47 149.6 119.1 111.2
29:28 … 115.2 -0.10 143.0 118.4 110.7 29:43 CE 115.8 -0.04 147.4 110.1 110.7
16:20 MAX 135.9 18:11 MIN 135.4
Drying pulses 05 CYCLE END 01/02/11 10:28
STERILIZATION: POSITIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EXTENDED REPORT
REQUESTED BY THE OPERATOR
Report following a
Manual Stop
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0007/0015 Selection 134 °C POROUS/WRAPPED Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIONATED Drying STANDARD
CYCLE START 01/02/11 11:13
Time C bar
---------------------------------------------------------­00:01 CS 077.6 +0.01 01:40 1PV 088.7 -0.80 04:40 1PP 120.6 +1.00 05:40 2PV 062.9 -0.80 07:10 2PP 135.6 +1.00 08:20 3PV 135.5 -0.80 11:20 ET 135.4 +2.15 11:39 SS 135.5 +2.17 12:39 135.5 +2.14 13:39 104.1 +2.15 14:39 047.5 +2.15
STERILIZATION: NEGATIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ALARM CODE: E999 DESCRIPTION MANUAL STOP
----------------------------------------------------------
Report following a
Blackout
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0006/0012 Selection 134 °C CUSTOM Temperature 134 °C Pressure 2.10 bar Process time 07 min Stand-by HIGH Pre-vacuum FRACTIONATED Drying FAST
CYCLE START 01/02/10 15:31
BLACK OUT 01/02/11 15:45
STERILIZATION NEGATIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ALARM CODE: E000 DESCRIPTION BLACK-OUT
67
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68
Report following an alarm
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0007~001 Selection 134 °C POROUS/WRAPPED Temperature 134 °C Pressure 2.10 Bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIONATED Drying STANDARD
CYCLE START 01/02/11 11:30
Time T1 P T2 T3 T4
------------------------------------------------------------------­00:01 CS 075.1 -0.00 130.9 115.2 093.4 00:11 074.9 -0.28 133.3 114.2 094.0 00:21 074.4 -0.46 146.3 113.2 094.5 00:31 074.3 -0.57 152.6 112.2 095.0 00:35 .. 074.3 -0.59 154.2 111.9 095.2 00:51 .. 078.9 -0.62 152.2 110.4 095.6 01:01 .. 074.9 -0.73 146.6 109.6 095.7 01:27 .. 047.8 -0.78 149.3 107.7 095.7 01:57 .. 047.8 -0.80 155.3 105.8 095.4 02:07 .. 076.5 -0.57 149.9 105.2 095.1 02:17 .. 081.1 -0.49 142.1 104.6 094.6 …………… …………… 08:15 … 068.4 -0.76 151.8 104.7 102.3 08:22 … 061.1 -0.80 153.6 104.5 101.7
08:32 ... 097.4 +0.01 154.7 104.0 100.8 08:42 … 104.6 +0.24 148.9 103.7 101.0 …………… …………… 15:04 … 135.5 +2.15 143.3 111.7 131.7
15:19 … 135.9 +2.17 148.5 113.5 132.6 15:28 … 135.3 +2.16 153.6 115.9 133.0 …………… …………… 19:19 … 135.5 +2.15 157.4 126.5 132.5
19:34 … 134.4 +1.07 157.0 126.8 131.2 19:49 … 108.3 +0.25 156.4 126.8 119.9 19:53 DS 104.4 +0.00 156.1 126.6 116.2
STERILISATION NEGATIVE
ALARM CODE: A112 DESCRIPTION PTC SHORTCIRCUIT
CAUTION !
PLEASE REFER TO USER MANUAL
Cycle Report
HELIX/BD TEST
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0011/0019 Selection HELIX TEST Temperature 134 °C Pressure 2.10 bar Process time 3.5 min CYCLE START 01/02/11 16:38
Time C bar
---------------------------------------------------------­00:01 CS 076.4 +0.00 02:06 1PV 089.3 -0.89 04:35 1PP 120.4 +0.99 05:45 2PV 062.5 -0.78 07:02 2PP 120.2 +0.97 08:15 3PV 061.1 -0.79 11:00 .. 135.6 +2.15 11:14 .. 136.0 +2.17 12:14 135.6 +2.14 13:14 135.6 +2.15 14:14 135.5 +2.14 14:45 .. 135.4 +2.14 15:20 .. 111.5 +0.00 16:34 … 047.8 -0.89 18:21 … 059.5 -0.86 19:21 .. 075.4 -0.50 20:06 CE 078.7 -0.04
12:33 MAX 136.0 14:44 MIN 135.4
Drying pulses 01 CYCLE END 01/02/11 17:01
HELIX TEST COMPLETE Please attach the indicator hereunder
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cycle Report
VACUUM TEST
Model BRAVO 17V S/N 12 JP 0001 Ver. SW Exxxx/JPyyyyyy Counter 0011/0019 Selection VACUUM TEST
CYCLE START 01/02/11
11:37
Time C bar
---------------------------------------------------------­00:00 CS 035.0 +0.00
01:39 E1F 037.4 -0.80
6:39 E2F 038.4 -0.79
22:39 E3F 042.0 -0.79
23:54 CE 045.5 -0.01
CYCLE END 01/02/11 12:01
VACUUM TEST: POSITIVE
OPERATOR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NOTE
when a usb key is inserted, it is always possible to eleCtroniCally baCkup the
printing reports.
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For better quality maintenance, supplement ordinary checks with regular periodic examinations by a qualied technical service department (see Appendix G).
It is highly recommended users perform a periodic sterilizer validation or 'check' of the thermodynamic parameters of the process by comparing them with the reference values provided with suitably calibrated instruments. In this regard, see “Periodic Sterilizer’s Validation”, below.
The ordinary maintenance described is easy to complete and involves simple instruments.
WARNING
IN THE EVENT OF THE REPLACEMENT OF THE DEVICE’S COMPONENTS OR PARTS, REQUEST AND/OR USE ORIGINAL REPLACEMENT PARTS ON LY.
The table summarizes the maintenance required to keep the sterilizer operating at peak efciency. In the case of very intense use, we recommend shortening maintenance intervals:
DAILY
Clean the gasket on the porthole Clean external surfaces
WEEKLY
Clean the sterilization chamber and relative accessories Disinfect external surfaces
MONTHLY
Clean the internal (and external - if installed) distilled water tank Safety valve maintenance Clean (or replace) the drain lter
ANNUAL or
every 1000
cycles
Replace the door gasket
EVERY 3 YEARS
or 3000 cycles
Recommended complete maintenance of the sterilizer by an authorized dealer
The steriliser periodically reminds the user about recommended “routine” maintenance operations that must be carried out in order to ensure the proper operation of the device.
The reminder notices are displayed on the screen when a sterilisation cycle is started:
(ALERT MESSAGES)
to confirm
to delay
Push the key to conrm the recommended "routine" maintenance operation has been performed.
Press the
key to postpone the message.
The user is reminded with another message the next time the steriliser is used.
INTRODUCTION
APPENDIX C MAINTENANCE
In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efcient operation over the device’s entire life.
ROUTINE MAINTENANCE
Scheduled Maintenance Messages
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70
NOTE
The user is given warning messages with the following frequency:
MESSAGES FREQUENCY
CHAMBER FILTER CLEANING Every 200 cycles
BACTERIOLOGICAL FILTER REPLACEMENT Every 400 cycles
CHAMBER GASKET REPLACEMENT Every 1.000 cycles
GENERAL REVISION Every 3.000 cycles
Whenever signicant reductions in performance, repeat alarms or a visible dete­rioration of parts subject to wear is noted, it is recommended that maintenance operations be carried out in advance of the deadlines programmed in the system.
Keep the following general warnings in mind:
– Do not wash the sterilizer with direct jets of water, either under pressure or sprinkled. Seepage
into electrical and electronic components could damage the functioning of the device or its internal parts;
– Do not use abrasive cloths, metal brushes (or other aggressive materials) or metal-cleaning
products, whether solids or liquids, to clean the device or sterilization chamber;
– Do not use chemical products or disinfectants to clean the sterilization chamber. In fact, these
products can damage the sterilization chamber, even irreparably;
– Do not allow lime residue or other substances to accumulate in the sterilization chamber or
on the door and its gasket. They can damage these parts in addition to compromising the operation of the components installed along the plumbing circuit.
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71
NOTE
the formation of white spots on the base of the internal walls of the
sterilization Chamber means that you are using low-quality demineralized water.
DANGER
BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT THE POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET.
WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER OF THE EQUIPMENT POWER SUPPLY LINE.
IF THE EXTERNAL BREAKER IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE EXTERNAL BREAKER AFTER TURNING IT OFF.
To remove traces of lime, clean the door gasket of the container and the porthole (door plate) with a clean, cotton cloth soaked in a weak solution of water and vinegar (or similar product). Dry the surfaces and remove any residue before using the device.
Clean all the external parts using a clean cotton cloth dampened with water and, if needed, a neutral detergent. Dry the surfaces and remove any residue before using the device.
Clean the sterilization chamber, support and trays (and internal surfaces in general) with a clean cotton cloth soaked in water and, if needed use a small amount of neutral detergent. Carefully rinse with distilled water, taking care not to leave any type of residue in the chamber or on accessories.
NOTE
do not use sharp or pointed instruments to remove lime enCrustation from the
sterilization Chamber. whenever there are visible deposits, immediately CheCk the quality of the distilled water used (see Appendix A
,).
MAINTENANCE DESCRIPTION
Clean gasket and porthole
to remove any traces of lime
Clean external surfaces
Clean sterilization chamber and accessories
Disinfect external surfaces
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72
For the occasional disinfection of the external surfaces, you can use either denatured alcohol or detergents with a small percentage of sodium hypochlorite (or equivalent).
1. Arrange an empty container on the oor near the sterilizer and insert the free end of the tube.
2. Insert the other end of tube in the quick-coupling marked “Service” positioned on the front as shown in the gure below.
3. Allow the tank to empty completely, and then disconnect the tube.
4. Prepare 4 litres/1.06 US Gal of distilled water and 10 % of pure alcohol, such as isopropyl and then pour it into the distilled water tank following the procedure indicated in the chapter “Loading Distilled Water” until the maximum level has been reached.
5. Let the solution sit for 30 minutes.
WARNING
IN THE MEANTIME, DO NOT CARRY OUT ANY STERILISATION CYCLE.
Cleaning the internal tank
Clean external distilled water tank (optional)
Safety valve maintenance
6. Repeat step 2 and completely empty the internal tank again (as in point 2).
7. Run one empty (no load) cycle of your choice.
1. Disconnect the external tank from the steriliser and close the tank valve.
2. Fill the tank with a solution of distilled water and alcohol (10%), such as isopropyl.
3. Allow the solution to sit for 30 minutes.
4. Drain the tank and discard the solution.
5. Fill the tank with water and drain it to remove any residual alcohol solution.
6. Reconnect the tank to the sterilizer and rell with distilled water.
1. Access the safety valve located on the rear of the machine.
2. Loosen the knurled locking ring with your ngers (or a suitable tool inserted in the two holes in
the ring itself), turning counter-clockwise until it reaches the end and turns loosely.
3. Pull the ring towards the outside a few times.
4. Retighten the locking ring making sure the threads are properly engaged.
5. Denitively tighten the locking ring all the way down.
WARNING
THE USER SHOULD PERFORM THIS OPERATION MONTHLY TO GUARANTEE THE CORRECT FUNCTIONING OF THE VALVE OVER TIME. AT THE END OF THE MAINTENANCE, MAKE SURE THAT THE LOCKING RING IS COMPLETELY SCREWED ON AND TIGHTENED.
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1
2
Over time various residues will accumulate inside the lter, obstructing the lower drain tube.
To clean (or replace) the lter, open the sterilizer door and remove the cap (1) with a coin. Loosen the tting (2) and the lter (3). Remove the lter from the support and put it under running water to thoroughly clean. Use a sharp tool, if necessary, to remove possible material of greater dimension.
If the filter cannot be reused, replace it with a new one.
NOTE
a replaCement baCteriologiCal filter is supplied with the deviCe. to request others,
please refer to Appendix G, TechnicAl supporT
.
Reassemble all the parts in reverse order. Pay attention when screwing the tting (2) back into the tting so that the drain holes (4) is at the same level as the chamber wall.
NOTE
properly insert the filter into its housing; partial insertion may Cause damage to the Component.
When it is due to be changed, or when you notice visible clogging of the lter (when the lter turns gray) unscrew the bacteriological lter from its support and replace it with a new one by screwing it all the way down on the connector on the front of the machine.
NOTE
a replaCement baCteriologiCal filter is supplied with the deviCe. to request
others, please refer to Appendix G, TechnicAl supporT
.
To replace the paper in the printer:
1. Open the door (1) of the service compartment to access the printer.
2. Press the tabs and the green button at the same time to open the door and access the paper compartment.
3. Remove the empty roll and place a new roll of thermal paper so that the paper unrolls off the top.
the roll must have the following dimensions:
- width 57 mm (2.24") / diameter max 50 mm (1.96").
4. Unroll about 15 cm (6") of paper and close the compartment door (the paper will automatically advance outside the window for several centimeters).
5. Thread the paper in the slot of door of the service compartment and reclose.
Clean/replace the drain filter
Replace bacteriological filter
Replacing the printer paper
Printer type 1
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To ensure proper performance of the unit, complete maintenance should be performed by a authorized dealer.
Ensuring the sterilizer is routinely maintained and properly calibrated over time is the responsibility of the user.
The complete maintenance recommendation requires the use of special equipment. It is therefore necessary to contact Technical Service to perform this maintenance.
NOTE
the sCiCan Customer support department (see Appendix G
)
Can provide any
information relative to the periodiC maintenanCe of the bravo.
In accordance with Directives 2002/95/ EC, 2002/96/ EC and 2003/108/ EC, regarding the reduction in use of dangerous substances in electrical and electronic equipment, as well as waste disposal, such equipment may not be disposed of as normal urban waste and must be separated accordingly. When purchasing a new, equivalent piece of equipment, the old piece of equipment that has reached its end-of-life must be handed over to the reseller for proper disposal. As regards reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer carries out the functions dened in the individual national legislations. The proper collection and separation of such equipment for recycling, treatment and disposal helps avoid any possible negative effects on the environment and health and facilitates the recycling of the materials of which the equipment is made. The crossed out rubbish can symbol indicates that the product, at the end-of-life, must be collected separately from other types of waste.
WARNING! Improper disposal of the product results in the application of sanctions which are defined by individual national laws.
PERIODIC STERILIZER MAINTENANCE (EVERY 3000 CYCLES)
DISPOSAL AT END-OF-LIFE
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APPENDIX D TROUBLESHOOTING
INTRODUCTION
ANALYSIS AND RESOLUTION OF PROBLEMS
If your sterilizer is not working correctly, please make the following checks before calling the Technical Support Department:
PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
The sterilizer does not power-on.
The power cord is not plugged-in. Plug it in.
There is no voltage at the socket.
Check the cause of the lack of voltage at and socket and x it.
The main switch and/or differential switch are OFF.
Turn the switch ON.
The mains fuses are blown.
Replace with good fuses of equal nominal value.
(See the Summary Table in Appendix A, Technical Characteristics).
After pressing START, the sterilization cycle does not start.
The device is preheating.
Wait for the sterilizer to reach the proper operating conditions for starting the program.
NOTE: Under normal conditions, the
average preheating time is about 10-15 minutes.
The MIN water level icon is lit.
The distilled water level inside the tank is below the minimum level.
Fill the distilled water tank until the MAX level indicator comes on (or, at any rate, until the MIN level signal turns off).
The alarm icon is lit.
An alarm was triggered, with the generation of the relative code and message (see LCD).
Check the alarm code and take the appropriate action.
(See the following paragraphs, Alarms, Alarm Codes and Troubleshooting).
The safety valve has intervened.
Locking ring loosened.
Presence of anomalous overpressure in the chamber.
Check that the knurled locking ring is correctly tightened on the upper part of safety valve.
DANGER
LET THE DEVICE COOL, OR WEAR GLOVES TO AVOID BEING BURNED WHEN TOUCHING THE VALVE.
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76
PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
At the end of the program (CYCLE COMPLETE), I’m not able to open the door.
There is residual pressure remaining in the sterilization chamber at the end of the cycle.
NOTE: the display shows:
NOW LEVELLING PLEASE WAIT
Wait several minutes, until the pressure returns to 0.00 bar, and try to open the door again.
Check if the bacteriological lter is clogged and, if necessary, replace it with a new one.
The procedure for storing the ambient temperature (SET 0 bar function) was not executed correctly.
Contact the Technical Support Department (see Appendix G).
At the end of the cycle, the safety door lock remains on.
Contact the Technical Support Department (see Appendix G).
There is water on the support surface of the sterilizer.
Drain connectors or tubing (optional external tank) not correctly connected to the device.
Check the tightness of the ttings; if necessary, reassemble, paying more attention to sealing.
Check that the tubes to the drain tank are completely pushed onto the connectors; make sure that the plastic ties have been applied.
The water supply tube from the external tank (optional) is not well connected.
Check the tightness of the connector; if necessary, reassemble, paying greater attention to sealing (see the Chapter,Installation”). Check that the tube coming from the external tank is completely pushed onto the connector; make sure that the plastic tie has been applied.
Steam leaks from the gasket.
At the end of the cycle, clean the gasket and porthole of the container under pressure. Check if the gasket is damaged. Run another cycle and check the situation. If the gasket still leaks, replace it with a new one.
There is water around the drain tank.
Drain tubes (optional drain tank) not correctly connected to the tank.
Check that the tubes connected to the drain tank are correctly and completely pushed-on to the connectors.
The sterilizer has problems creating a vacuum in the chamber (drying problems, presence of water in the sterilization chamber at the end of the cycle, etc.).
Drain lter of the sterilization chamber obstructed.
Clean or replace the drain lter.
(See Appendix CMaintenance”).
Drain circuit obstructed or drain tubes choked (optional drain tank).
Check that the drain tubes (and the connectors they are pushed onto) are not obstructed and run freely from the device to the tank.
The air intake on the frame and/or the cover are obstructed or the heat exchanger is not sufciently ventilated.
Remove all possible obstructions from the air intake and heat exchanger.
Check that the device is not in direct contact with walls or surfaces (see the Chapter, Installation”).
Excessive humidity on the material and/or instruments at the end of the program.
There is too much of material inside the sterilization chamber.
Check the quantity of material sterilized and make sure that it does not exceed the maximum allowed quantity, depending on the type of load. (See the Summary Table in Appendix A, Technical Characteristics”).
Material not correctly positioned.
Position the material, and especially wrapped material, according to the instructions. (See the Chapter, Preparing the Material”).
Wrong sterilization program selection.
Select the appropriate sterilization program for the type of material to be treated. (See the Summary Table in Appendix B, “Programs”).
Drain lter of the sterilization chamber obstructed.
Clean or replace the drain lter, Check for kinks in the exhaust tube, if being used. (See Appendix CMaintenance”).
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PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
Traces of oxidation or spots on instruments.
Quality of the instruments is not adequate.
Check the quality of the instruments with the problem, checking whether the material they are made of can tolerate steam sterilization.
Quality of the distilled water not adequate.
Empty the tank and ll it with high­quality distilled water.
(See the Water Supply Characteristics in Appendix A, “Technical Characteristics”).
Organic or inorganic residues on the instruments.
Carefully clean the material before subjecting it to the sterilization cycle.
(See the Chapter, Preparing the Material”).
Contact between instruments made of different metals.
Separate instruments made of different metals.
(See the Chapter, Preparing the Material”).
Lime residue on the wall of the sterilization chamber and/or accessories.
Clean the device and its parts, as required. (See Appendix CMaintenance”).
Blackening of the instruments or damage to the material.
Wrong sterilization program selection.
Check the adequacy of the sterilization temperature of the selected program in relation to the material to be treated.
(See the Summary Table in Appendix B, “Programs”).
The printer (optional on some models) is not printing the summary report.
Wrong printer conguration.
Congure the sterilizer for the type of printer used (Configuration program). (see the Chapter, Configuring the Device”).
Out of paper.
Insert a new roll of paper.
(See Appendix C, “Replacing the Paper”).
Paper jammed.
Clear the jam. Check the dimensions of the roll of paper.
(See Appendix C, “Replacing the Paper”).
NOTE
should the problem persist, ContaCt the Customer serviCe (see Appendix G) providing the model of the sterilizer
and the serial number. this information is found on the serial number plate on the rear of the deviCe and on the deClaration of Conformity.
Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is generated, and a specic code (consisting of a letter followed by a 3-digit number) is displayed.
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Alarm codes are divided into three categories:
· E = ERROR Operator error or a cause external to the device. A problem that can generally be xed by the user. Code format: Exxx (xxx = identifying number from 000 ÷ 999)
· A = ALARM First-level fault, not linked to safety. A problem that normally is xed by a specialized technician on-site. Code format: Axxx (xxx = identifying number from 000 ÷ 999)
· H = HAZARD Second-level fault, linked to safety. A problem generally xed by the Technical Support Center. Code format: Hxxx (xxx = identifying number from 000 ÷ 999)
NOTE
in the Case of an alarm, please only remove voltage from the deviCe after exeCuting
a reset (see the paragraph, “resetting the system”).
An alarm causes the interruption of the cycle with the relative alarm code displayed on the display, accompanied by a beep and a ashing alarm icon.
NOTE
during the alarm proCedure, the display always shows the Current temperature
and pressure in the sterilization Chamber.
This procedure is designed to keep the user from misinterpreting an anomalous cycle for a correctly completed cycle and, as a consequence, involuntarily using non-sterile material.
The alarm procedure is differentiated depending on whether it occurs during the execution of the program or outside, and is structured to guide the user to the necessary RESET of the sterilizer.
If the alarm intervenes during a program, the display will show the message:
(Alarm Message)
LEVELLING
114.6 °C XXXX
0.70 bar 11:30
Whenever an alarm is generated in certain phases of the cycle, an automatic procedure is activated to clean the internal water circuit. The display will contain the notice:
(Alarm Message)
CIRCUIT CLEANING
100.6 °C XXXX
0.70 bar 11:40
APPENDIX E ALARMS
INTRODUCTION
ALARM INTERVENTION
Alarm during a cycle
Alarm message
Alarm code
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At the end of what has been described and having reached safe conditions, the machine activates a special procedure, that asks the user to manually unlock the door:
PRESS TO
UNLOCK THE DOOR
101.O °C XXXX
0.01 bar 11:40
NOTE
the above indiCated message is shown only when the pressure in the Chamber is within
a safe limit.
t
he release of the loCking deviCe is not possible when the pressure value is outside
this limit.
Press the key to unlock the door lock mechanism; the following message appears:
(Alarm Message)
OPEN THE DOOR
100.8 °C XXXX
0.01 bar 11:42
Once the door is open, the user is nally asked to reset the system:
(Alarm Message)
RESET SYSTEM
95.5 °C XXXX
0.00 bar 11:43
Perform a RESET (described below) and then turn-off the equipment and check the error or make the repair.
NOTE
when the door is opened, the report (normal or extended depending on the type of
alarm) will be printed for the interrupted sterilization program and the alarm that intervened. CheCk the doCument, initial it in the spaCe provided and file it in a suitable plaCe. refer to the print report examples shown in appendix b, programs”.
If the alarm intervenes outside the sterilization or test program the display will show:
(Alarm Message)
ALARM!
80.5 °C XXXX
0.00 bar
Turn-off the equipment and check the alarm. Or, depending on the type of alarm:
(Alarm Message)
WARNING!
80.5 °C XXXX
0.00 bar
which automatically transformed to the message:
(Alarm Message)
RESET SYSTEM
80.5 °C XXXX
0.00 bar
Alarm outside the cycle
Alarm message
Alarm code
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Perform a RESET (described below) and then turn-off the device and check the alarm.
NOTE
alarms that intervene outside of a program do not produCe a printed report.
The system is RESET in two alternative ways, depending on the alarm that occurred (see the Alarm Code List further below in this appendix):
1. Press the PROGRAM SELECTION key for about 3 seconds.
A beep confi rms the RESET.
WARNING
NEVER TURN THE DEVICE OFF BEFORE EXECUTING A RESET.
2. Turn-off the device and then power-on using the main switch.
Upon power-up, the sterilizer will perform its normal initial test.
After a RESET and any technical operation necessary to eliminate the fault, the device goes into STANDBY ready to execute a new program.
RESETTING THE SYSTEM
>3s
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ALARM CODES
The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows:
CODE ALARM DESCRIPTION LCD INDICATION RESET MODE
ERRORS (category E)
E 000 Blackout BLACK-OUT
Press key
+
(> 3 seconds)
E 010 Door open DOOR OPEN
E 020
Exceeded timeout for activating door lock system (closing)
DOOR UNLOCKED
E 021
Exceeded timeout for activating door lock system (opening)
DOOR LOCKED
E 030 Water in the ll tank at minimum (MIN) level WATER MIN
E 031 Water in the drain tank at maximum (MAX) level EXHAUST MAX
E 041
Filling the tank too frequently (automatic filling)
FILLING PROBLEM
E 900
Vacuum Test failed (during the LEAKAGE PHASE)
TEST FAILED
E 901
Vacuum Test failed (during the WAITING PHASE)
TEST FAILED
E 902
Vacuum Test failed (vacuum pulse timeout exceeded)
TEST FAILED
E 999 Manual cycle interruption MANUAL STOP
ALARMS (category A)
A 022
System door lock microswitches failed (OFF­OFF)
LOCKING PROBLEM
Turning-off
device
A 023 System door lock microswitches failed (ON-ON) LOCKING PROBLEM
A 024 System door lock microswitches failed (ON-OFF) LOCKING PROBLEM
A 032 Sensor-level problem LEVEL PROBLEM
A 040
Failure to ll the tank (automatic filling)
FILLING PROBLEM
A 101
PT1 broken (sterilization chamber)
PTC BROKEN
A 102
PT2 broken (steam generator)
PTC BROKEN
A 103
PT3 broken (heating element)
PTC BROKEN
A 104
PT4 broken (sterilization chamber wall)
PTC BROKEN
A 111
PT1 short-circuited (sterilization chamber)
PTC SHORTCIRCUIT
A 112
PT2 short-circuited (steam generator)
PTC SHORTCIRCUIT
A 113
PT3 short-circuited (heating element)
PTC SHORTCIRCUIT
A 114
PT4 short-circuited (sterilization chamber wall)
PTC SHORTCIRCUIT
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CODE ALARM DESCRIPTION LCD INDICATION RESET MODE
A200
Pre-heating not performed within the timeout (heating resistor problem)
HEATING PROBLEM
Press key
+
(> 3 seconds)
A 250 1st vacuum pulse not reached within timeout PV1 TIMEOUT
A 251
1st rise to atmospheric pressure not reached within timeout
ATM1 TIMEOUT
A 252 1st pressure pulse not reached within timeout PP1 TIMEOUT
A 253 2nd vacuum pulse not reached within timeout PV2 TIMEOUT
A 254
2nd rise to atmospheric pressure not reached within timeout
ATM2 TIMEOUT
A 255 2nd pressure pulse not reached within timeout PP2 TIMEOUT
A 256 3rd vacuum pulse not reached within timeout PV3 TIMEOUT
A 257
3rd rise to atmospheric pressure not reached within timeout
ATM3 TIMEOUT
A 258 3rd pressure pulse not reached within timeout PPP TIMEOUT
A 259 Phase of PROCESS not started within timeout PROCESS TIMEOUT
A 260
Chamber depressurization not completed within timeout
PPD TIME-OUT
HAZARDS (category H)
H 150 MPX pressure sensor broken MPX BROKEN
Turning-off
device
H 160
MPX pressure sensor short-circuited/not connected
MPX SHORTCIRCUIT
H 400
Ratio P
conv
/T not balanced (P
conv
>T)
(Phase PROCESS)
P/T PROBLEM
Press key
+
(> 3 seconds)
H 401
Ratio T/P
conv
not balanced (T>P
conv
)
(Phase PROCESS)
T/P PROBLEM
H 402
Temperature above MAX limit (Phase PROCESS)
T OVER LIMIT
H 403
Temperature below MIN limit (Phase PROCESS)
T UNDER LIMIT
H 404
Temperature uctuating over the limit (Phase PROCESS)
PT1 FLUCTUATING
H 405
Pressure above MAX limit (Phase PROCESS)
P OVER LIMIT
H 406
Pressure below MIN limit (Phase PROCESS)
P UNDER LIMIT
H 410
Wrong maintenance time
(Phase PROCESS)
TIMING PROBLEM
H 990
Excessive pressure
(sterilization chamber, MPX)
OVERPRESSURE
H 991
Overheating (sterilization chamber, PT1)
OVERHEATING PT1
H 992
Overheating (steam generator, PT2)
OVERHEATING PT2
H 993
Overheating (band heating element, PT3)
OVERHEATING PT3
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ANALYSIS AND RESOLUTION OF PROBLEMS
Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct operation:
CODE POSSIBLE CAUSE PROPOSED SOLUTION
ERRORS (category E)
E 000
Sudden power failure (blackout).
Wait for electricity to return and perform RESET following the instructions.
Accidentally turning-off the main switch and/or pulling the plug out of the socket.
Reconnect the plug and/or power-on the device and perform RESET following the instructions.
Mains fuses blown.
Replace with good fuses of equal nominal value. (See the Summary Table in Appendix A, Technical Characteristics”). Turn-on the device and perform RESET following the instructions.
E 010
Door open (or not properly closed) at the start of the program (START).
Perform RESET following the instructions.
Close the door properly and restart the program.
Door position microswitch broken.
Contact the Technical Support Department
(see Appendix G).
E 020
Limit microswitch (CLOSED position) of the door lock mechanism broken.
Perform RESET following the instructions.
Try to start the program a second time.
If the problem persists contact the Technical Support Department (see Appendix G).
Door lock system gear motor broken.
E 021
Limit microswitch (OPEN position) of the door lock mechanism broken.
Perform RESET following the instructions.
Contact the Technical Support Department (see Appendix G).
Door lock system gear motor broken.
E 030
Water level in the ll tank below minimum (MIN) level.
Perform RESET following the instructions.
Top-off the water until the MAX level indicator comes on (or at least until MIN indicator goes off).
MIN water level indicator broken.
Contact the Technical Support Department (see Appendix G).
E 031
Water level in the drain tank (or possible optional external drain tank) over the MAX level.
Perform RESET following the instructions and empty the tank.
If installed, empty the external tank (optional), leaving water up to the level indicated.
Wire of the external tank (optional) level indicator not connected to the device.
Perform RESET following the instructions.
Connect the plug of the level indicator wire (coming from the optional external tank) to the female socket located on the back of the device.
MAX water level indicator broken.
Contact the Technical Support Department (see Appendix G).
E 041
Connection tube between the sterilizer and a possible external lling device not correctly installed.
Perform RESET following the instructions. Check that the water supply tube is correctly and solidly
connected to the relative connectors. Eliminate all possible obstructions along the path of the
tube.
External lling container is empty.
Ensure the external lling container is lled with distilled water.
Water lling pump broken.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
E 900
Air leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again.
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
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CODE POSSIBLE CAUSE PROPOSED SOLUTION
E 901
Excessive humidity in the sterilization chamber.
Perform RESET following the instructions.
Carefully dry the inside of the sterilization chamber and start the program again.
Air leaking through the gasket
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again.
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
E 902
Excessive humidity in the sterilization chamber.
Perform RESET following the instructions.
Carefully dry the inside of the sterilization chamber and start the program again.
Air leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again.
Vacuum pump broken.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
E 999
Manual interruption of sterilization or test
program.
(Also see the Chapter, Running the Program”).
Perform RESET following the instructions.
Check that the load has been correctly sterilized (see LCD indicators) before using the material.
ALARMS (category A)
A 022
Limit microswitch(es) on the door lock mechanism broken.
Contact the Technical Support Department (see Appendix G).
A 023
Limit microswitch(es) on the door lock mechanism broken.
A 024
Limit microswitch(es) on the door lock mechanism broken.
A 032
Connector of the water level indicators not connected.
Level indicator(s) broken.
A 040
Lack of water in the external tank or Milldrop turned off (automatic lling).
Perform RESET following the instructions.
Fill the tank with a sufcient quantity of water, remembering to periodically check the level, or turn on the Milldrop.
Connection tube between the sterilizer and a possible external lling device not correctly installed.
Perform RESET following the instructions.
Check that the water supply tube is correctly and solidly connected to the relative connectors.
Eliminate all possible obstructions along the path of the tube.
Water lling pump broken.
Contact the Technical Support Department (see Appendix G).
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CODE POSSIBLE CAUSE PROPOSED SOLUTION
A 101
Chamber temperature sensor (PT1) broken.
Contact the Technical Support Department (see Appendix G).
A 102
Steam generator temperature sensor (PT2) broken.
A 103
Heating element temperature sensor (PT3) broken.
A 104
Chamber wall temperature sensor (PT4) broken.
A 111
Incorrect connection of the temperature
sensor (sterilization chamber) to the connector.
Temperature sensor short circuit (sterilization chamber).
A 112
Incorrect connection of the temperature
sensor (steam generator) to the connector. Temperature sensor short circuit
(steam generator).
A 113
Incorrect connection of the temperature
sensor (heating element) to the connector.
Temperature sensor short circuit (heating element).
A 114
Incorrect connection of the temperature
sensor (chamber wall) to the connector.
Temperature sensor short circuit (chamber wall).
A 200
Intervention of the steam generator safety thermostat.
Manually rearm the thermostat(s) located on the back of the device (see the Chapter, Product Introduction”).
Unscrew the protective plastic cap, press the button until you hear a soft click and then ret the cap.
Turn-off (RESET) and then turn-on the device.
If the problem persists contact the Technical Support Department (see Appendix G).
Intervention of the heating element safety thermostat.
Steam generator or heating element malfunctioning.
A 250
Presence of water or condensate in the sterilization chamber.
Perform RESET following the instructions.
Carefully dry the inside of the sterilization chamber and start the program again.
Do not put material impregnated with water, or liquids in general, in the chamber.
Drain lter of the sterilization chamber obstructed.
Clean or replace the drain lter. (See Appendix CMaintenance”).
Air leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again.
Vacuum pump broken.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
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CODE POSSIBLE CAUSE PROPOSED SOLUTION
A 251
Water injection pump malfunction.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
A 252
Steam leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again. If the gasket still leaks, replace the gasket.
Excessive load.
Perform RESET following the instructions.
Check the quantity of material in the sterilization chamber and make sure it does not exceed the maximum quantity allowed.
(See the Summary Table in Appendix A, Technical Characteristics).
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
A 253
Presence of water or condensate in the sterilization chamber.
Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program again. Do not put material impregnated with water, or liquids in general, in the chamber.
Air leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again. If the gasket still leaks, replace the gasket.
Vacuum pump broken.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
A 254
Water injection pump malfunction.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
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CODE POSSIBLE CAUSE PROPOSED SOLUTION
A 255
Steam leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again. If the gasket still leaks, replace the gasket.
Excessive load.
Perform RESET following the instructions. Check the quantity of material in the sterilization chamber and make sure it does not exceed the maximum quantity allowed. (See the Summary Table in Appendix A, Technical Characteristics).
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
A 256
Presence of water or condensate in the sterilization chamber.
Perform RESET following the instructions.
Carefully dry the inside of the sterilization chamber and start the program again.
Do not put material impregnated with water, or liquids in general, in the chamber.
Air leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water.
Start the program again. If the gasket still leaks, replace the gasket.
Vacuum pump broken.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
A 257
Water injection pump malfunction.
Contact the Technical Support Department (see Appendix G).
Problem in the plumbing circuit.
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
A 258
Steam leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water and start the program again.
Excessive load.
Perform RESET following the instructions. Check the quantity of the material in the sterilization chamber and make sure that it does not exceed the maximum allowed quantity, depending on the type of load. (See the Summary Table in Appendix A, Technical Characteristics).
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
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CODE POSSIBLE CAUSE PROPOSED SOLUTION
A 258
Intervention of the steam generator safety thermostat.
See A200
If the problem persists contact the Technical Support Department (see Appendix G).
Heating element safety thermostat intervened.
Heating or steam generator heating element malfunction.
A 259
Excessive load.
Perform RESET following the instructions. Check the quantity of the material in the sterilization chamber and make sure
that it does not exceed the maximum allowed quantity, depending on the type of load.
(See the Summary Table in Appendix A, Technical Characteristics).
Steam leaking through the gasket.
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with water and start the program again.
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
A 260
Drain lter of the sterilization chamber obstructed.
Clean or replace the drain lter (See Appendix CMaintenance”).
Problem in the plumbing circuit.
Contact the Technical Support Department (see Appendix G).
HAZARDS (category H)
H 150 Pressure sensor (MPX) broken.
Contact the Technical Support Department (see Appendix G).
H 160
Incorrect connection of the pressure
sensor (MPX) to the connector.
Pressure sensor (MPX) short circuit.
H 400 Problem in the plumbing circuit.
H 401 Problem in the plumbing circuit.
H 402
Steam generator malfunction.
Problem in the plumbing circuit.
H 403
Steam generator malfunction.
Problem in the plumbing circuit.
H 404
Problem in the plumbing circuit.
Steam generator malfunction.
H 405
Problem in the plumbing circuit.
Steam generator malfunction.
H 406
Problem in the plumbing circuit.
Steam generator malfunction.
H 410 Timer problem.
H 990 General operating problem.
H 991 General operating problem.
H 992 General operating problem.
H 993 General operating problem.
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APPENDIX F – NOTES FOR THE OPERATOR
Page 94
90
APPENDIX G – TECHNICAL SUPPORT
FOR ANY REQUEST FOR
TECHNICAL SERVICE FOR THE PRODUCT,
WHETHER IN OR OUT OF WARRANTY,
DIRECTLY CONTACT THE
TECHNICAL SUPPORT DEPARTMENT
OF THE DEALER OR RESELLER
THAT SUPPLIED THE PRODUCT.
SciCan is completely available to customers to provide any technical information about the product as well as to offer suggestions and advice on steam sterilization procedures.
In this regard, please refer to the following address:
SciCan Ltd. 1440 Don Mills Road Toronto, Ontario M3B 3P9 CANADA
website www.scican.com
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APPENDIX H – LIMITED WARRANTY
Limited Warranty
For a period of two years or 2500 cycles, which ever appears rst, SciCan guarantees that the Bravo Autoclave, when manufactured by SciCan in new and unused condition, will not fail during normal service due to defects in material and workmanship that are not due to apparent abuse, misuse, or accident.
The two year warranty will cover the performance of all components of the unit except consumables such as the door seal, microbiological lter, water lter, wire racks and trays, provided that the product is being used and maintained according to the description in the operator’s manual.
In the event of failure due to such defects during this period of time, the exclusive remedies shall be repaired or replaced, at SciCan’s option and without charge, of any defective non-consumable part(s) (except gasket), provided SciCan is notied in writing within thirty (30) days of the date of such a failure and further provided that the defective part(s) are returned to SciCan, prepaid.
This warranty shall be considered to be validated if the product is accompanied by the original purchase invoice from the authorized SciCan dealer, and such invoice identies the item by serial number and clearly states the date of purchase. No other validation is acceptable. After two years or 2500 cycles, all SciCan’s warranties and other duties with respect to the quality of the product shall be conclusively presumed to have been satised. All liability therefore shall be terminated, and no action or breach of any such warranty or duty may thereafter be commenced against SciCan.
Any express warranty not provided hereon and any implied warranty or representation as to performance, and any remedy for breach of contract which, but for this provision, might arise by implication, operation of law, custom or trade or course of dealing, including any implied warranty of merchantability or of tness for particular purpose with respect to all and any products manufactured by SciCan is excluded and disclaimed by SciCan.
If you would like to learn more about SciCan products and features, visit our website at www.scican.com
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