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Page 17

1.21.

Symbols Description

Manufacturer

Year of Manufacturing

Medical Device

Model Number

Serial Number

Consult the Operation and Maintenance Manual (User
Manual) before use

Keep away from sunlight and protect from heat.

For Indoor Use Only

Keep dry

Disposal according to electronic scrap ordinance

Содержание Elara11

Страница 1: ...ve Model Elara11 Cat No MAN205 0497002EN Rev H Tuttnauer Co Ltd Har Tuv Industrial zone B P O Box 170 Beit Shemesh 9910101 Israel Tel 972 2 9904611 Fax 972 2 9904730 Tuttnauer U S A Co Ltd 25 Power Dr...

Страница 2: ...ANEL 21 2 1 DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL 22 2 2 VISUAL INFORMATION CENTER 22 2 3 THE CONTROL CENTER 23 2 4 DATA CENTER 24 2 5 DISPLAYED ERROR MESSAGES SYMBOLS 24 2 6 DISPLAYED OPERATIO...

Страница 3: ...2 WASTEWATER RESERVOIR 84 9 3 OPENING THE DOOR 84 9 4 ADDING ADDITIONAL DRYING TIME 85 9 5 LOADING 85 9 6 CYCLE DESCRIPTION 87 9 7 EXTRA DRYING TIME 88 9 8 UNLOADING 88 10 PREVENTIVE AND SCHEDULED MA...

Страница 4: ...al dental clinics 1 3 Intended Users The Elara11 tabletop autoclave is intended for use by hospital personnel and other medical personnel All autoclave users must receive training in proper usage from...

Страница 5: ...om Tuttnauer The warranty also does not include routine cleaning or preventive maintenance to be performed according to instructions in Sec 10 Preventive and Scheduled Maintenance Tuttnauer s obligati...

Страница 6: ...s appropriate sterilization conditions Never use the autoclave to sterilize liquids since it is not designed for that purpose Never use the autoclave to sterilize corrosive products such as acids base...

Страница 7: ...g in the vicinity of electrical equipment which is not certified for Electromagnetic Compatibility according to IEC EN 61326 1 14 A certified inspector must perform a periodic pressure chamber safety...

Страница 8: ...t stage of the cycle More efficient steam penetration into the load assuring effective sterilization Improved temperature uniformity throughout the chamber Better drying of materials due to the vacuum...

Страница 9: ...unit ensures a fully automatic sterilization cycle control and monitoring of physical parameters and clear documentation of the sterilization cycle The Elara11 features a digital absolute pressure dis...

Страница 10: ...ave been run on your autoclave Track the parameter setting that have been used in each of the cycles and stages run Choose the style of the report to view either graph table or a print out All reports...

Страница 11: ...erial Minimum room ventilation shall be 10 cycles per hour The environment shall not exceed an ambient temperature range of from 41 F 5 C to 104 F 40 C and a relative humidity of 85 Operate the autocl...

Страница 12: ...Page 11 1 11 Overall Dimensions...

Страница 13: ...free water reservoir 13 Plastic door cover 4a Water reservoir fill and level gauge 5 Chamber and steam generator safety valves inside the reservoir 14 Autoclave Leg 6 Wastewater reservoir 15 Wastewat...

Страница 14: ...port 2 Wastewater reservoir 7 Jacket cut off thermostat 3 Ventilation grills 8 Generator cut off thermostat 4 Air filter service cover 9 Main power electric cable socket 5 Wastewater outlet to drain W...

Страница 15: ...ber Diameter 11 280mm Chamber Depth 19 8 504mm Chamber volume 7 5 gal 28 5 lit Max Allowable Working Pressure MAWP 40 psi 2 8 bar Maximum instrument load per item 0 7 lbs 0 3 kg Maximum instrument loa...

Страница 16: ...is recommended that a ground fault protection device GFCI be installed in the electrical panel feeding the autoclave local codes may make this mandatory The electrical network must comply with local...

Страница 17: ...oclave until it reaches 1 below the bottom of the base of the safety valves LAB048 0355 Near the mineral free water reservoir cover Caution Hot steam LAB048 0058 Near the safety valve Do not pour wate...

Страница 18: ...of Manufacturing Medical Device Model Number Serial Number Consult the Operation and Maintenance Manual User Manual before use Keep away from sunlight and protect from heat For Indoor Use Only Keep dr...

Страница 19: ...p during transport and shipment Fragile during transport and shipment A warning or precaution as detailed in the Operation and Maintenance Manual User Manual Caution Hot Surface Caution Hot steam Prot...

Страница 20: ...mg l 0 1 mg l Conductivity at 20 C 15 s cm 3 s cm pH value 5 to 7 5 5 to 7 Hardness 0 02 mmol l 0 02 mmol l Appearance Colorless clean without sediments Note The condensate is produced from steam take...

Страница 21: ...tion VIII Div I PED 2014 68 EU Chinese Regulations Special Equipment Licensing Office EN 13060 Small Steam Sterilizers ANSI AAMI ST55 Table Top Steam Sterilizer ISO 17665 Sterilization of health care...

Страница 22: ...Page 21 2 CONTROL PANEL No Description 1 Display 2 On off switch and circuit breaker 3 Keypad 4 USB Port 5 Printer Standard 1 2 3 4 5 Visual Information Center Control Center Data Center...

Страница 23: ...on Center The information center contains the display which is an LCD panel used to display the current status of the autoclave and any Operational Messages or Error Messages Program description Progr...

Страница 24: ...functions In the main screen o This key enables the operator to browse through the cycles In the menu directories o When the cursor is blinking on a number the DOWN key decreases its value When the c...

Страница 25: ...f the processes that have been run on your autoclave Track the parameter settings that have been used in each of the cycles and stages run Choose the style of the report to view either graph table or...

Страница 26: ...this manual to change the time or to cancel this option Start cycle by clock is active This message is displayed if the user presses START STOP key while the start cycle by clock mode is active Starti...

Страница 27: ...r reservoir by plugging the included drain tube into the wastewater drain see front view This symbol is displayed and the cycle will not start if the steam pressure in the generator has not reached th...

Страница 28: ...e cycle is progressing The following screens are a representation of what will be seen during a cycle 3 1 Screens showing a successfully completed cycle 1 System Ready 2 Starting 3 Pulse L 4 Pulse H 5...

Страница 29: ...led by user AFTER complete sterilization stage The sterilization stage ended successfully however the operator manually aborted the remainder of the cycle by pressing the START STOP key This resulted...

Страница 30: ...ing sequence of screens showing the reason for the aborted cycle Note The user will have to press the START STOP key after the mandatory 1 minute drying to clear the message and unlock the door 3 3 Sc...

Страница 31: ...ble reach the proper temperature This resulted in the following sequence of screens showing the reason for the aborted cycle Note The user will have to press the START STOP key after the mandatory 1 m...

Страница 32: ...3 2 Failure due to Cancellation by user BEFORE completing the sterilization stage Note The user will have to press the START STOP key after the mandatory 1 minute drying to clear the message and unloc...

Страница 33: ...cleared sterilization programs a calibration program for use by a technician an extra drying program a vacuum test program and a Bowie and Dick test program The FDA cleared program parameters are set...

Страница 34: ...he user should use only those sterilizer accessories Biological Indicators Chemical Indicators etc that have been cleared by the FDA for the specific cycle time and temperature of this device The stag...

Страница 35: ...parameters are set and cannot be altered Operations Sequence Air removal stage a series of vacuum pulses are performed Heating stage steam is injected into the chamber from the steam generator until...

Страница 36: ...ons sequence Air removal stage a series of vacuum pulses are performed Heating stage steam is injected into the chamber from the steam generator until the sterilization temperature is reached Steriliz...

Страница 37: ...er parameters are set and cannot be altered Operations sequence Air removal stage a series of vacuum pulses are performed Heating stage steam is injected into the chamber from the steam generator unti...

Страница 38: ...nce Air removal stage a series of vacuum pulses are performed Heating stage steam is injected into the chamber from the steam generator until the sterilization temperature is reached Sterilization pha...

Страница 39: ...fault settings Calibration temperature 273 2 F 134 C Calibration time 15 minutes Drying time 1 minute is the minimum value set when no drying is required Operations Sequence Air removal stage a series...

Страница 40: ...Time For all loads when the load requires additional drying after the cycle is completed Nominal parameters default settings Drying time 5 minutes may be changed by the operator see sec 5 1 1 Operati...

Страница 41: ...his point the test begins and lasts 10 minutes At the end of the test the printer records the results The pressure at the end of the test is referred to as P3 Notes During the test period the autoclav...

Страница 42: ...d pressure are maintained constant at the pre set level during the sterilization time Fast exhaust steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure Dry...

Страница 43: ...est programs and all parameters are locked Spore testing is your only assurance of complete sterilization Once entering the programming mode the operator will see and have access to the following dire...

Страница 44: ...tures will require an access code The User s access code is 0001 2 To exit this screen or any screen in this section press the UP or DOWN key to move the cursor to Exit and press START STOP key 5 1 1...

Страница 45: ...ersion to USB Accessing the Export current version feature allows the operator to export the machines current application for evaluation by a technician a Insert the USB device into the USB Socket loc...

Страница 46: ...to Export all settings to USB device c Press the START STOP key The following screen will be displayed 3 All cycle history 4 Last 10 cycles 5 Last 50 cycles Accessing the export cycle history feature...

Страница 47: ...Select this option and the following screen will be displayed This subdirectory offers the following options Print last cycle Print last 5 cycles Print last 10 cycles This feature allows the operator...

Страница 48: ...rt cycle by clock This option allows scheduling the selected cycle to start at a later time The maximum possible delay is 24 hours No other program can be run while the Start Cycle by Clock is active...

Страница 49: ...OP key to move the cursor to exit 6 Use the UP or DOWN key to exit 7 The cycle is now enabled Note When Start Cycle by clock is enabled this icon will be displayed on the main screen Once the cycle ha...

Страница 50: ...e will cause a Time Error and the unit will not run properly This option enables the operator to set the date and time The following screen will be displayed The time is displayed in the upper row in...

Страница 51: ...Setting the Date and time will cause the autoclave software to automatically reload 5 1 7 Login Accessing additional feature requires entering a password follow these steps 1 Select Login and press th...

Страница 52: ...screen The following screen is displayed See section5 2 for more details on the MAIN MENU 5 1 8 Exit Selecting Exit and pressing the START STOP key will bring you back to the main screen 5 2 Main Menu...

Страница 53: ...n saver is activated When the screen saver is on the machine is asleep The door is locked and the heaters are off Awaken the machine by pressing the Start Stop key The default time is 90 minutes Setti...

Страница 54: ...gram to modify the System Parameters 2 Enter the programing mode by pressing the UP and DOWN keys simultaneously for 1 2 seconds and then release 3 Login using the User code 0001 4 Select System Param...

Страница 55: ...imum minimum and default value for this parameter It also shows the current parameter setting 7 Use the UP and DOWN keys to change the desired value 8 Use the START STOP key to advance the blinking cu...

Страница 56: ...st Print all gain and offset Modifying a maintenance parameter 1 Select any program from the Main Screen to access the Maintenance options 2 Enter the programing mode by pressing the UP and DOWN keys...

Страница 57: ...sections 5 2 3 1 Reset atmospheric pressure This is an option to manually reset the Atmospheric pressure parameter Note The atmospheric pressure parameter is set automatically however this parameter c...

Страница 58: ...Page 57 To exit this screen press the START STOP key 5 2 3 2 Printer Test This option enables the operator to test the printer The printer will provide the following print out...

Страница 59: ...All Gain and Offset This option allows for printing all the gain and offset values This information is for use by a factory engineer The printer will provide gain and offset for the following Chamber...

Страница 60: ...ter 1 Select any program from the Main Screen to access the advanced options 2 Enter the programing mode by pressing the UP and DOWN keys simultaneously for 1 2 seconds and then release 3 Login using...

Страница 61: ...the parameters in a custom program it is necessary to select that program from the Main Screen before entering the MAIN MENU directory This directory includes seven subdirectories and the parameters...

Страница 62: ...it was named Custom A The following instructions show how to modify one of the Custom A parameters in this case Pulse A Count will be modified These basic instructions apply to all the parameters 1 U...

Страница 63: ...62 4 Login using the User code 0001 4 Select Cycle Parameters Custom A from the Main Menu 5 Use the UP or DOWN keys to move to the Create Pulse subdirectory as shown in the table in sec 5 3 2 Pressing...

Страница 64: ...he parameter to be changed it shows the maximum minimum and default values for this parameter It also shows the current parameter setting 8 Use the UP and DOWN keys to change the desired value See the...

Страница 65: ...y Custom programs are not FDA cleared It is the user s responsibility to validate any Custom cycles This device utilizes vacuum pulses for removing air from the chamber prior to sterilization The Crea...

Страница 66: ...ressure Defines the pressure that the top exhaust valve opens at the top of each pulse Psia 0 73 43 51psia 01 Pulse B Count Defines the number of pulses in pulse group B Whole Number 0 10 1 Pulse B St...

Страница 67: ...nt Defines the number of pulses in pulse group D Whole Number 0 10 1 Pulse D Stay Time Defines the additional time that the top exhaust valve will remain open after reaching the pressure set by the Pu...

Страница 68: ...amber pressure is less than atmospheric 4 5psi otherwise Slow Exhaust 3 Slow Exhaust 4 Slow Exhaust if the chamber has not completed sterilization otherwise Fast Exhaust Whole Number 1 4 1 Dry Time Dr...

Страница 69: ...heating elements during the second stage of the drying cycle Seconds 0 120 1 Additional Dry Time Defines the number of additional minutes to add to the default dry time Minutes 0 60 1 End Temperature...

Страница 70: ...tervals according to the phase of the process as shown in the table on the next page The data is printed from the bottom up beginning with the date and ending with Cycle Ended For an aborted cycle Cyc...

Страница 71: ...ure during sterilization Beginning of the timer verification of the sterilization phase The time temperature and pressure during heating The time temperature and pressure during heating The time tempe...

Страница 72: ...ng on POWER ON The device is turned on Time 00 00 00 Time of turning off Date 9 FEB 2010 Date of turning off POWER OFF The device is turned off Legend A Vacuum stage Pulse L Pulse H D Drying stage H H...

Страница 73: ...ng the paper roll compartment 4 Paper Feed key 5 Paper roll compartment 6 Paper end of roll sensor Fig 1 1 Open the printer s cover door 3 by pulling it at the left bottom corner 2 see Fig 2 Fig 2 2 P...

Страница 74: ...excess paper using the jagged edge see Fig 3 4 Fig 3 7 Close the printer s cover door 3 by pressing corner 2 with the tip end of the paper emerging from the slot 1 See Fig 2 on previous page 6 2 3 Not...

Страница 75: ...steam generator 1 Disconnect the power supply cord 2 Drain the water from both reservoirs see sec 10 4 Attention The pressure of the generator does not decrease immediately when the equipment is turn...

Страница 76: ...ing the autoclave to leave space around the machine for ventilation and to give the technician access to service the machine It is recommended that a minimum 2 50mm space be provided Insufficient spac...

Страница 77: ...oclave then plug it into the supply outlet 5 Turn on the power switch located on the right side of the unit 6 Set Date and Time will appear on the screen On initial set up it is important to set the d...

Страница 78: ...en filling Note This reservoir is designed with an overflow and filling the reservoir above the safe level as indicated on the Front Fill Funnel will cause excess water to spill out below the machine...

Страница 79: ...he Front Fill Funnel will cause excess water to spill out below the machine onto the counter CAUTION USE STEAM DISTILLED WATER ONLY having the characteristics as per table in sec 1 22 The impurities i...

Страница 80: ...s of the sterilizer Notes To protect sensors at the back bottom of the chamber the rack of the Elara11 is designed with stops for the bottom tray It is normal for the bottom tray to be closer to the d...

Страница 81: ...lized 11 Disassemble or sufficiently loosen multiple part instruments prior to packaging to permit the sterilizing agent to come into contact with all parts of the instrument 12 Verify that packaging...

Страница 82: ...d there are no sharp bends or twists 21 Cassettes or packs should be placed on the tray rack in place of the trays They should not be touching each other or the Chamber walls There should be about 1 2...

Страница 83: ...clave needs to be cleaned or that the instruments were not adequately cleaned prior to sterilization If removal of the spot reveals pitting then the spot is most likely oxidation oxidation spots on an...

Страница 84: ...the unit is turned on the pre heating begins The steam generator begins heating and the symbol is displayed until the generator is ready The chamber is also pre heated and the symbol is displayed unti...

Страница 85: ...perature of the wastewater can be over 200 F 93 C Plastic drainpipe cannot tolerate temperatures above 140 F 60 C An external heat exchanger may be required to cool the discharge 9 3 Opening the Door...

Страница 86: ...layer deep When using paper poly bags the paper side should be down Using a TuttnauerTM Pouch Rack will insure good air circulation and more efficient drying 9 5 Loading 1 Load the autoclave properly...

Страница 87: ...figures below showing examples o f using a combination of trays and racks for sterilizing heavy or diverse loads The Elara11 is supplied with 5 wire trays NOTE The Elara11 can accommodate 2 pouch rac...

Страница 88: ...ts performing the sequence of operations The actual measured values of pressure and temperature are displayed continuously and printed o n t h e p r i n t e r The display shows the current stage of th...

Страница 89: ...eat resistant gloves to remove the load from the autoclave On completion of the cycle the load shall be visually inspected to ascertain that the load is dry and that sterilization indicators have made...

Страница 90: ...cycle was aborted before completing the sterilization stage it will leave the load unsterilized Handle it as a contaminated load If the cycle is aborted before completing the sterilization stage the...

Страница 91: ...om pre heating and proceed with cleaning Caution Make sure the autoclave is not hot before cleaning it Clean the door door gasket and outside rim of the chamber with a mild detergent water and a soft...

Страница 92: ...asionally drain the water from the mineral free water reservoir once a week and refill with fresh distilled water see 7 6 Once a week or when symbol is displayed whichever comes first drain the water...

Страница 93: ...oir The drain valve is located on the front right side of the autoclave after the door is opened 1 The function of the drain valve is to drain the water reservoir 1 To drain the reservoir use item 5 w...

Страница 94: ...al HEPA filter The filter is mounted on the rear wall of the autoclave enclosure to allow easy access for replacing see Rear View position 4 To replace the filter proceed as follows 1 Remove the filte...

Страница 95: ...ecure the filter cover by turning it a turn clockwise Verify that the tube has not been kinked and that the cover is fastened securely Note It is recommended to replace the air filter every 6 months o...

Страница 96: ...erring to the directions below 1 Pull off the gasket from the groove 2 Clean the groove of any remnants of the old gasket use a plastic scraper and plain water as needed 3 Line the inside of both side...

Страница 97: ...If insufficient lubricant is applied replacing the gasket will be difficult If excess lubricant is applied the gasket will spring out of the groove Place the gasket inside the groove and press it in w...

Страница 98: ...ng shows the correct direction of the gasket Gasket Door 10 7 Checking the Safety Valve There are two safety valves located in the mineral free water reservoir To prevent the safety valve from becomin...

Страница 99: ...e ring for 2 seconds and then release it Be careful not to burn your hands 2 After 2 3 seconds the safety valve should close automatically 3 Press the START STOP key to abort the cycle and allow the s...

Страница 100: ...avoid injuries 1 Turn the unit on momentarily to allow the door to be opened Then turn the unit off to stop the chamber from preheating 2 Remove the trays and the tray holder 3 Remove the strainer el...

Страница 101: ...open the door follow this procedure 1 Turn the power switch off 2 Wait at least one hour until the autoclave cools down 3 Verify that there is no pressure in the autoclave chamber by pulling the ring...

Страница 102: ...Display is not activated The on off switch is in the off position The power cord is not connected properly to the machine and the power source There is no electrical power in the main source Turn the...

Страница 103: ...ing sterilization cycle Perform a new cycle The chamber may be overloaded remove some material from the chamber Check for steam leakage around the door Clean or replace the door gasket if necessary If...

Страница 104: ...the problem persists call for service High Pressure Ending This message is displayed if the system cannot reach atmospheric pressure 0 74psi 5kPa during the ending stage Wait until the chamber reaches...

Страница 105: ...STOP key to clear the error message and perform a new cycle Cycle Failed This message and symbol are displayed if an error occurs before sterilization cycle is completed Press the START STOP key to cl...

Страница 106: ...s restored This icon is displayed when the mineral free reservoir needs water Fill the mineral free reservoir with steam distilled water This symbol is displayed when the wastewater reservoir is full...

Страница 107: ...10 pack 13 ACCESSORIES PART NUMBER DESCRIPTION CMT240 0097 Handle Tray THE002 0052 Printer PLUSII S2B 0004 TRH411 0021 Holder Tray TRY254 0003 Tray WIR040 0005 Power cable 16A AR910 Elara11 Pouch rac...

Страница 108: ...Page 107 TRAY TRY254 0003 TRAY HOLDER TRH411 0021 Drain Tube GAS083 0004...

Страница 109: ...Page 108 Drain Tube connector VLV170 0014 Air filter FIL175 0042...

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