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3.13

Directives and Standards

Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:

3.13.1

Technical Directives

1. Pressure Equipment Directive 97/23/EC.
2. Council Directive for low voltage equipment 73/23/EEC.

3.13.2

Technical Standards

1. ASME code
2. EC-61010-1 & IEC-61010-2-040 - Safety requirements for

medical device.

3. EN 61326 – EMC Requirements .

3.13.3

Quality standards

The manufacturing plant meets the following quality standards:

1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.

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Содержание 2840 EL-D

Страница 1: ...onic Table top Autoclave with cooling option Model 2840 EL D Cat No MAN205 0450001EN Rev A Tuttnauer Europe b v Hoeksteen 11 4815 PR Breda P O Box 7191 4800 GD Breda Netherlands 31 76 5423510 0Fax 31...

Страница 2: ...s and Standards 16 4 CONTROL PANEL 19 4 1 Control Panel Drawing 19 4 2 Description and Functions of the Front Panel Keyboard 20 4 3 Displayed Error Messages Symbols 22 4 4 Displayed operational messag...

Страница 3: ...ATA 44 12 1 Directories and subdirectories 44 12 2 Table of parameters 45 12 3 Entering the main menu 46 12 4 Cycle Parameters Custom program duplicate program 48 12 5 Cycle Parameters Create Pulse 49...

Страница 4: ...Page 3 of 77 14 TROUBLESHOOTING 73 15 SPARE PARTS LIST 77 16 ACCESSORIES 77...

Страница 5: ...Page 4 of 77 TABLE OF CONTENT Cont DRAWINGS PAGE NO FRONT VIEW 17 REAR VIEW 18...

Страница 6: ...ponents and assembly with the exception of the heaters The warranty does not include and does not replace routine treatment and preventive maintenance to be performed according to instructions in sec...

Страница 7: ...e the problem and provide a prompt solution If the autoclave is equipped with a printer send along a copy of the last printout for our inspection If replacement parts are needed stipulate the model an...

Страница 8: ...om an experienced employee Every new employee must undergo a training period under an experienced employee 3 A written procedure must be established for autoclave operation including daily safety test...

Страница 9: ...ation 13 Examine the condition of assemblies on a regular basis Make sure there are no leaks breaks blockages whistles or strange noises 14 It is required to conduct maintenance operations as instruct...

Страница 10: ...g personnel On all models a printer is an optional addition to the autoclave The printer prints the preset and actual parameters of the cycle temperature time and pressure vacuum The pressure scale pr...

Страница 11: ...2000 meters 6561 feet ambient pressure shall not be lower than 80 kPa 11 6 psi The autoclave shall not be used in a manner not specified in this manual Do not use the autoclave in the presence of dan...

Страница 12: ...m 17 4 Length C 605 mm 23 8 Maximum dimensions door open D 950 mm 37 Distance between supporting legs F front legs F1 rear legs K 415 mm 16 3 F 315 mm 12 4 F1 400 mm 15 7 Overall Dimensions Property V...

Страница 13: ...on s Small W 212 mm 8 3 H 21 mm 0 8 L 350 mm 13 7 Big W H L Max Allowable Working pressure MAWP 2 8 bar 40 psi No of trays 5 IMS cassettes optional 4 full 4 half 3 5 Electrical Data Specifications Val...

Страница 14: ...there is an easy access to the main power switch to the water cut off valve and to the current leakage safety relay 3 7 Environment Emission Information 1 The peak sound level generated by the autocla...

Страница 15: ...an standards Electronic pressure and temperature measurement Safety relief valve to avoid build up of excessive pressure Door switch enabling operation to be started only when the door is closed Water...

Страница 16: ...ad 0 05 mg kg Rest of metals except iron cadmium lead 0 1 mg kg Chloride Cl 0 1 mg kg Phosphate P2O5 0 1 mg kg Conductivity at 20 C 3 s cm pH value degree of acidity 5 to 7 Appearance Colourless clean...

Страница 17: ...Pressure Equipment Directive 97 23 EC 2 Council Directive for low voltage equipment 73 23 EEC 3 13 2 Technical Standards 1 ASME code 2 EC 61010 1 IEC 61010 2 040 Safety requirements for medical devic...

Страница 18: ...r switch 3 Printer cover 11 Door closing device 4 RJ 45 connection 12 Water reservoir funnel 5 Printer option 13 Water level gauge 6 USB connection 14 Autoclave cover 7 Legs 15 Display 8 Mineral free...

Страница 19: ...Page 18 of 77 REAR VIEW No Description 1 Ventilation grills 2 Drain line water strainer 3 Main power electric cable socket 4 Mineral free water reservoir cover 1 4 1 3 2...

Страница 20: ...Page 19 of 77 4 CONTROL PANEL 4 1 Control Panel Drawing No Description 1 Display 2 Keypad Up Button 3 Keypad Start Stop Button 4 Keypad Down Button 5 Printer 3 5 1 2 4...

Страница 21: ...isplay screen The display is a LCD panel used to display the current status of the autoclave while using Operational Messages and Error Messages Chamber temperature No 1 System status Name of stage Er...

Страница 22: ...e operator to browse through the cycles In the directories available o When the cursor is blinking on a number the DOWN key decreases its value o When the cursor is blinking on menu selection the DOWN...

Страница 23: ...le information for subsequent consideration 4 3 Displayed Error Messages Symbols The failures are divided into two categories 1 Failure that occur before completing the sterilization stage which in th...

Страница 24: ...scribed in this manual to change the time or to cancel this option Cycle by clock This message is displayed if the user presses START STOP key while the cycle by clock mode is active Enter the Admin m...

Страница 25: ...exhausted from the chamber bringing the internal pressure down to atmospheric pressure 5 5 Cooling The autoclave is designed to operate two liquid cooling cycles as follows 5 6 Sealed bottles cooling...

Страница 26: ...Page 25 of 77...

Страница 27: ...by actuation of electrical heaters until the sterilization temperature is reached Sterilization temperature is maintained constant during the sterilization time For Liquids Only Slow exhaust steam is...

Страница 28: ...successfully cycle Cycle Ended 1 System Ready 2 Starting 3 Insert Water 4 Steam Flush 5 Keep Heat 6 Heat 7 Sterilization 8 Exhaust 9 Ending 10 Cycle Ended Display can be activated only by an authoriz...

Страница 29: ...the reason of failure is displayed For example the next two scenarios 7 2 1 Canceled by user after complete sterilization stage The cycle ended successfully the reason for aborted cycle is displayed...

Страница 30: ...or example the next two scenarios 7 3 1 Failure according to Pressure Time Error 7 3 2 Failure according to Cancellation by user before complete sterilization stage When Cycle Failed appears on the sc...

Страница 31: ...starts performing the sequence of operations of the cycle The measured values of temperature and pressure are printed at fixed time intervals according to the phase of the process as shown in the tabl...

Страница 32: ...0 10 22 115 1 200 4 The time temperature and pressure during Air removal A 00 10 00 113 7 162 5 The time temperature and pressure during Air removal A 00 07 00 098 7 200 5 The time temperature and pre...

Страница 33: ...Optional E Exhaust stage 8 2 Printer Handling 8 2 1 Maintenance Wipe off the soiling on the printer surface with a dry soft cloth with a weak neutral detergent After that wipe the printer with a dry...

Страница 34: ...Page 33 of 77...

Страница 35: ...nter in a place of extreme humidity or any place where it can possibly be splashed by any liquids If any liquids get into the printer it could lead to fire electric shock or other serious accidents Ne...

Страница 36: ...l to allow ventilation and to facilitate the device disconnection If placed in a cabinet verify that the rear of the cabinet is open to allow ventilation Insufficient space for ventilation may result...

Страница 37: ...t of water The upper red section 2 indicates that the water level in the reservoir is too high Caution Under no circumstance should water be filled above the top sign level the line between section 2...

Страница 38: ...g the reservoir before starting a cycle see sec 12 2 Caution Use only water having the characteristics as per table in sec 3 9 Tap water may clog the system and using them can invalidate the manufactu...

Страница 39: ...an instruments thoroughly to dispose of any residue 3 It is recommended to wash instruments with an ultrasonic cleaner using detergent and mineral free water 4 Launder textile wraps prior to reuse 5 A...

Страница 40: ...ir and moisture e g hollowware so that only minimal resistance to removal of air the passage of steam and condensate will be met 7 Load items within the boundaries of the tray so that they do not touc...

Страница 41: ...iquids 1 Use only heat proof glass filled 2 3 full 2 Ensure that the glass container is covered but not sealed to prevent pressure build up 3 Place the two temperature sensors into two separate liquid...

Страница 42: ...plastic door cover 1 and the other fingers in the handle 3 2 Pull the handle 2 until the locking of the door is released 3 Open the door 11 3 Loading Load the autoclave properly according to instruct...

Страница 43: ...he autoclave starts performing sequence of operations The actual measured values of pressure and temperature are displayed continuously and printed every minute at STE stage and every 5 minutes at the...

Страница 44: ...indicators have made the required color change 11 6 Stopping the process and canceling the ERROR message It is possible to stop the program while the autoclave is operating Pressing the START STOP ke...

Страница 45: ...seen 12 1 Directories and subdirectories The operator Admin may perform the following DIRECTORY SUBDIRECTORY Cycle Parameters applicable only for Custom programs See sec 7 4 Cycle Parameters Custom P...

Страница 46: ...ssure Define the minimum vacuum pressure level in the second pulses group 160 0 kPa 5 200 1 Pulse B High Pressure Define the maximum vacuum pressure level in the second pulses group 180 0 kPa 5 200 1...

Страница 47: ...START STOP key In order to exit the ENTER CODE screen move the cursor to Exit by pressing START STOP Key When Exit is blinking press UP or DOWN keys The following screen will be displayed 3 0000 is di...

Страница 48: ...ory is blinking press the START STOP key The required screen will be displayed 9 In order to exit this screen Move the cursor to Exit with the UP or DOWN keys and select it by pressing the START STOP...

Страница 49: ...erature Cool Exhaust Rate Exhaust Exhaust Mode Ending End Temperature Exhaust Mode Drying Dry Tqaime Dry Exhaust Mode Dry Heat On 1 Dry Heat Off 1 Dry first stage time Dry Heat On 2 Dry Heat Off 2 End...

Страница 50: ...at steps 1 4 for the following parameters Pulse A Stay Time Pulse A Low Pressure Pulse A High Pressure Pulse B Count Pulse B Stay Time Pulse B Low Pressure Pulse B High Pressure 12 6 Cycle Parameters...

Страница 51: ...e displayed 1 Set the required value move to Set and press UP or DOWN keys to confirm the parameter value 2 In order to exit move the cursor to Exit and press UP or DOWN keys 3 Repeat steps 1 4 for th...

Страница 52: ...rature 2 SET PARAMETER screen will be displayed 3 Set the required value move to Set and press UP or DOWN keys to confirm the parameter value 4 In order to exit move the cursor to Exit and press UP or...

Страница 53: ...rinting rate during the whole cycle except sterilization stage 2 SET PARAMETER screen will be displayed 3 Set the required value move to Set and press UP or DOWN keys to confirm the parameter value 4...

Страница 54: ...ed when entering View old cycle history subdirectory 1 Choose the required cycle according to cycle number date and time with the UP or DOWN keys 2 Press the START STOP key The printer will print the...

Страница 55: ...press START STOP key 9 In order to exit the HISTORY OPTIONS screen Move the cursor to Exit with the UP or DOWN keys and select it by pressing the START STOP key or Press the UP and DOWN keys simultan...

Страница 56: ...ories move the cursor by pressing UP or DOWN keys to the required item and press START STOP key 2 In order to exit this screen Move the cursor to Exit with the UP or DOWN keys and select it by pressin...

Страница 57: ...sor from one digit to another press the START STOP key 3 After changing the time and the date move the cursor to Set 4 Confirm the new time and date by pressing UP or DOWN keys 5 After saving is compl...

Страница 58: ...sor to Exit with the UP or DOWN keys and select it by pressing the START STOP key Press the UP and DOWN keys simultaneously 12 13 3 Reset atmospheric pressure This sub directory enables to reset the a...

Страница 59: ...displayed Cycle errors None Canceled By User Door is open Analog Input Error I O Card Failed Power Down No Water Heat Time Error Vacuum Time Error Pressure Time Error Heat Time Error Keep Heat Time E...

Страница 60: ...ory enables the operator to print all the gain and offset values When pressing START STOP key on the Print all gain and offset item the printer will print out the following And the following screen wi...

Страница 61: ...S directory 1 In order to enter to the sub directories move the cursor by pressing UP or DOWN keys to the required item and press START STOP key 2 In order to exit this screen Move the cursor to Exit...

Страница 62: ...o another press the START STOP key 3 After changing the time move the cursor to Enabled 4 Confirm the START CYCLE BY CLOCK by pressing UP or DOWN keys 5 Move the cursor by pressing START STOP key to E...

Страница 63: ...STOP key 4 The following screen will be displayed 5 Remove the USB device from the USB Socket 6 In order to exit this screen and return to ADVANCED OPTIONS directory press START STOP key In order to...

Страница 64: ...escribed below 1 GUI Graphic user interface Holds the entire Human Machine interface including the main application screen and all the configuration screens which enable the user to handle the machine...

Страница 65: ...12 15 2 View factory default version information This subdirectory enables the operator to see the factory default version information In order to see this subdirectory press START STOP key on the Vi...

Страница 66: ...ean door gasket with a soft cloth The gasket should be clean and smooth A mild soapy solution may be used 13 1 2 Weekly by the operator 1 Check the interior of the autoclave If the autoclave is dirty...

Страница 67: ...ician Check the continuity of the grounding connections Calibrate the temperature and pressure Perform validation of the autoclave Checking the precise operation of the earth leakage relay Checking th...

Страница 68: ...rain the water reservoir 1 Connect the silicone hose supplied with the autoclave to drain into a bucket 2 Turn drain valve counterclockwise to the open position 3 Fully drain the reservoir 4 With a qu...

Страница 69: ...eat The air jet consists of a small orifice with a clean out wire inserted in it wire is permanently installed and will not come out It is required that the air jet be cleaned once per week or more of...

Страница 70: ...is necessary to allow the steam pressure to escape through it every month To avoid injuries begin this check while the autoclave is cold 1 Operate the sterilization cycle according to the manual 2 Al...

Страница 71: ...Page 70 of 77...

Страница 72: ...Page 71 of 77 Cap Gasket Strainer element Strainer Housing WATER STRAINER...

Страница 73: ...r level in the chamber is properly reported to the microprocessor all during the cycle The water sensor is located in the rear of the chamber It is easily cleaned using a damp cloth or sponge you may...

Страница 74: ...any Temperature sensor or Pressure sensor is disconnected or out of range Call the technician Chamber temperature not in range This message is displayed if the temperature in the chamber is too high...

Страница 75: ...132 C 286 kPa 121 C 205 kPa for 2 seconds during the sterilization stage Perform a new cycle High Pressure Ending This message is displayed if the system cannot reach atmospheric pressure 5kPa during...

Страница 76: ...ater Fill the mineral free water reservoir Cycle counter exceeded Please call for service Number of cycles since last periodical maintenance exceeded the preset number as defined by cycle counter para...

Страница 77: ......

Страница 78: ...Filter Air 0 2 Micron Model 50mm D THE002 0066 Thermal paper for CUSTOM PLUSII printer roll 57mm d 50mm 16 ACCESSORIES PART NUMBER DESCRIPTION GAS084 0007 Drain P V C Tube 8x12 THE002 0052 Printer PL...

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