Tuttnauer AMS11-120-T Operation And Maintenance Manual Download Page 8

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1. General Information

1.1 Manufacturer and US Official Correspondence
Information

T-Edge 11 Autoclave is manufactured by Tuttnauer Ltd., Located Har –

Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel.

)

Tel: +972-2-9904611

The US Official Correspondence is:

Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.

)

Tel: (631) 737 4850, (800) 624 5836,

Fax: (631) 737 0720

Page 1

Summary of Contents for AMS11-120-T

Page 1: ...er U S A Co Ltd 25 Power Drive Hauppauge NY 11788 U S A Tel 631 737 4850 800 624 5836 Fax 631 737 0720 Tuttnauer Ltd Har Tuv Industrial Zone B P O Box 170 Beit Shemesh 9910101 Israel Tel 972 2 9904611...

Page 2: ......

Page 3: ...120 T AMS11 120 W T Cat No MAN205 0502003EN Rev C June 2021 Tuttnauer U S A Co Ltd 25 Power Drive Hauppauge NY 11788 U S A Tel 631 737 4850 800 624 5836 Fax 631 737 0720 Tuttnauer Ltd Har Tuv Industr...

Page 4: ...https www tuttnauerusa com...

Page 5: ...ns 9 1 11 Device Environmental Information 13 1 12 Requirements with concern to Water Quality 13 2 SAFETY 15 2 1 Safety Notes 16 2 2 Safety features incorporated in the device 17 3 CONTENT OF THE DEVI...

Page 6: ...5 8 7 Aborting a cycle 56 8 8 Custom Programs 58 8 9 Cycles history 59 8 10 Opening the door and Unloading 61 8 11 Checking Waste Water Level 62 8 12 Draining the Reservoirs 62 9 PREVENTIVE AND SCHEDU...

Page 7: ...face cables to the printer 85 11 7 Connecting power and interface cables 86 11 8 Starting the printer 86 11 9 Setting Printer definitions 87 12 CHAMBER CLEAN PROGRAM 90 12 1 General 90 General 90 12 2...

Page 8: ...11 Autoclave is manufactured by Tuttnauer Ltd Located Har Tuv B Industrial Zone P O Box 170 Beit Shemesh 9910101 Israel Tel 972 2 9904611 The US Official Correspondence is Tuttnauer U S A Co Ltd 25 P...

Page 9: ...Medical Devices Regulations 2002 Brazilian Good Manufacturing Practices RDC ANVISA 16 2013 67 2009 56 2001 23 2012 Japanese QMS Ordinance MHLW MO 169 Canadian MDR CMDR SOR 98 282 2018 consolidated Gl...

Page 10: ...terility assurance in health care facilities IEC 61010 1 UL 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements IEC 61010 2 040...

Page 11: ...l Table 1 Device labeling Manufacturer Year of Manufacturing Catalog Number Serial Number Consult the Operation and Maintenance Manual User Manual before use IP31 Ingress Protection Keep away from sun...

Page 12: ...ctronic scrap ordinance This side up during transport and shipment Fragile during transport and shipment OR A warning or precaution as detailed in the Operation and Maintenance Manual User Manual OR C...

Page 13: ...e of the cycle l Steam penetration into the load resulting in effective sterilization l Temperature uniformity l Post sterilization drying phase A touchscreen is used for monitoring and control purpos...

Page 14: ...y Description This warranty does not include routine cleaning and preventive maintenance to be performed according to instructions in chapter 8 Tuttnauer warranties all new autoclaves to be free from...

Page 15: ...1788 USA Tel 631 737 4850 800 624 5836 Fax 631 737 0720 Tuttnauer Ltd Har Tuv B Industrial Zone P O Box 170 Beit Shemesh 9910101 Israel Tel 972 2 9904611 1 9 Customer Inspection Upon Receival of the D...

Page 16: ...1 10 Device Specifications 1 10 1 Overall Dimensions Page 9...

Page 17: ...than 3 percent 1 10 3 Device Properties Table 2 Properties of the device Property Dimension External size Width 19 7 50cm Height 19 7 50cm Depth 22 8 58 cm supporting common install base carry a 23 60...

Page 18: ...low up to the float 155 Ounces 4 6lit Min water volume 33 8 Ounces 1lit The volume used by the sterilization cycle load having the highest steam consumption Recorded 30 Ounces 900ml for Wrapped 273F V...

Page 19: ...upply fluctuation 10 Frequency Hz 60Hz 1 10 5 Utility Requirements Table 4 Requirements pertaining the utilities Property Value Mineral free water See table in Water Quality Mineral free water inlet O...

Page 20: ...peak sound level generated by the autoclave is 67dBa with background noise of 48dBa during sterilization stage and 65dBa during drying stage l The total heat per hour transmitted by the autoclave is...

Page 21: ...y have severe impact on the working life of the sterilizer and can invalidate the manufacturer s guarantee Use only deionized water having a maximum conductivity of 15 s cm Conductivity greater than 1...

Page 22: ...and hot surfaces Warning Don t place your hand or head etc above the door while opening it as hot steam is escaping the chamber Warning Do not stand near the back panel of the autoclave while the devi...

Page 23: ...before you remove the load l A certified inspector must perform a periodic pressure chamber safety test according to the local regulations l Once a year or more frequently effectiveness tests must be...

Page 24: ...trical door locking pin that blocks door opening during operation The following safety devices are installed in the autoclave to optimize its safe operation l Safety thermostat to prevent over heating...

Page 25: ...r Reservoir Drain 2 PIP511 0029 Tube with Angle Connector for Auto Reservoir Drain 1 FIL175 0176 Hose Seal With Filter Mesh 60 1 GAS086 0102 Hose Flexible St St Nut End RS331S12 Hydra 1 2 x200cm 1 WIR...

Page 26: ...View No Description No Description 1 Touch screen 6 Chamber 2 ON OFF switch 7 Door switches 3 Chamber Door 8 Air filter 4 Door Gasket 9 Mineral free water reservoir opening 5 Mineral free left and wa...

Page 27: ...aste outlet 2 LAN socket 7 Mineral free inlet available in AMS11 120 W T 3 Cut off Thermostat 8 Safety valve 4 Circuit breaker on off switch 9 Aeration Ventilation opening 5 Power socket Warning Mind...

Page 28: ...d surface and can carry a load of 165 lbs 75kg Caution The device is not designed for use on any standard slide out shelf If it is necessary to use a slide out shelf it must be tested and or rated for...

Page 29: ...nt pressure of 8 8 psi 60 5 KPa or higher is guaranteed as it is a function of altitude and temperature 11 Operate the autoclave only in the manner specified in the manual If the equipment is used in...

Page 30: ...he device see below 1 Plug the power cord into the power socket Warning Mind the Power socket Keep it and its vicinity dry Danger of electrocution 2 Turn ON the semi automatic ON OFF button switch loc...

Page 31: ...4 When you turn on the autoclave it will automatically warm up Warning Be careful the surfaces may be hot 5 Fill the Mineral Free Water Reservoir with water meeting the quality specs see Water Qualit...

Page 32: ...en the Autoclave door and verify that the Chamber s ambient temperature is below 113 F 2 In the Quick Option screen press the Settings icon then browse to Maintenance Reset atmospheric pressure 3 In t...

Page 33: ...2 Select the Version information 3 The Version information is displayed For an example see below Page 26...

Page 34: ...rn to the Info screen 5 Select the Play tutorial option to watch the T Edge 11 Instructional Video 6 The T Edge 11 Instructional Video can be accessed in the link below https tuttnauer com t edge10 en...

Page 35: ...thod and adequate rinsing and drying Cleaning dried blood is especially difficult because it flows and dries in difficult to clean locations It shall be washed away Mechanically scrubbing high pH dete...

Page 36: ...ated Carbon steel instruments should be bagged or placed on autoclavable towels and not directly on stainless steel trays mixing will result in damage to the instruments or trays from the oxidation of...

Page 37: ...the instruments it is necessary to determine if the spot is dirt or rust The first step would be to use an ordinary eraser to remove the spot If there is no pitting under the spot then the spot is onl...

Page 38: ...rbon steel and stainless steel When these two metals come into contact with each other electrolysis occurs that breaks down the metal The best solution is to separately wrap the carbon steel instrumen...

Page 39: ...he autoclave see the rear view and into the wall outlet Turn ON the semi automatic ON OFF bottom Switch located on the rear panel of the autoclave see the rear view Turn on the ON OFF switch mounted u...

Page 40: ...ling procedure in section 7 3 and Draining the Reservoir procedure in section 8 11 The water level icon appears when the water level in the reservoir is full See the filling procedure in section 7 3 a...

Page 41: ...ng tap water will clog the system and invalidate the manufacturer s guarantee To fill water in the reservoir Lift up the water reservoir cover see below Pour water into the reservoir through the water...

Page 42: ...The screen below displays a full clean water tank 7 4 See the requirements concerning Water Quality in Section 1 12 Page 35...

Page 43: ...installation On the main screen press the menu symbol to open the Quick Option screen From the Quick Option screen select the Set Date and Time icon Note The only functionality to be performed by the...

Page 44: ...A for types of sterilization cycles Table B provides the T Edge 11 Class B sterilization programs Table C provides the T Edge 11 Class S sterilization programs Table A Types of sterilization cycles Cl...

Page 45: ...3 Pre Post Vac Unwrapped Delicate 250F 250 F 4 Pre Post Vac Wrapped Delicate 250F 250 F 5 Chamber Clean 6 Bowie and Dick 273 F 7 Vacuum test Table C Class S sterilization cycles Cycle Name Sterilizati...

Page 46: ...er will provide you with a code password After entering the new code password by the customer user the autoclave will contain now the Class B features The following details the procedure to access Cla...

Page 47: ...6 A Class Settings message will appear confirming the action completed successfully 7 Press to complete conversion The autoclave is now converted to Class B and the screens displayed will have a Clas...

Page 48: ...Note The Class B sign is on the screen header The entire autoclave is now in Class B system a sample of the screens after the conversion to Class B are shown below Page 41...

Page 49: ...Note It is possible to switch back from Class B to Class S if desired following the steps above by selecting S in step 3 above instead of S B Entering the code password is required Page 42...

Page 50: ...ay the autoclave current status any Operational or Error Messages and for operating the machine Image 1 Home screen Program Select Screen This screen will be presented when the autoclave is switched o...

Page 51: ...erature in the chamber 6 Load no ID Load cycle number 7 Date and time It enables the operator to set the machine date and time screen 8 Full water level clean water tank The Water is full in the reser...

Page 52: ...7665 1 See the screen in the top next page 18 Vacuum Test See the screen in the bottom previous page 19 Chamber Clean Chamber Clean program cleans the autoclave chamber 20 Custom Duplicates a steriliz...

Page 53: ...k The door is locked when either the system is running a sterilization cycle or there is pressure in the chamber or the power is off If you need to open the door after cycle completes press the confir...

Page 54: ...lave properly see chapter 6 3 Choose the appropriate sterilization program 4 Each sterilization program screen contains a Virus Protect option Notes l The program can only be selected when the door is...

Page 55: ...andle When the door is closed the open door symbol is replaced with the closed door symbol 8 Press the Start button to start the cycle For cycle process description see Sterilization Cycle Description...

Page 56: ...Note For the results of the cycle see description in section 8 5 Page 49...

Page 57: ...for Textile and Porous programs 1 Select from a sterilization cycle the Virus Protect option 2 Raise the temperature to 230 F 110 C and wait for a period of 10 minutes for the Virus Protect process to...

Page 58: ...Note If the Virus Protect program fails the confirmation message below appears After pressing on OK in this message the system will release air outside of the autoclave Page 51...

Page 59: ...ams and Test Programs 8 5 1 List of available Sterilization and Test Programs Class B Notes The Unwrapped sterilization program can be used for sterilizing lumen device of no longer than 9 230mm and n...

Page 60: ...table for programs Solid Unwrapped 17 6 lbs 8 0kg Unwrapped Solid Wrapped 9 9 lbs 4 5kg Wrapped 8 5 3 Description of the Sterilization Cycle Stages Air removal stage Pre vacuum pulses are performed Fo...

Page 61: ...referred to as P3 Notes l During the test period the autoclave is not heated Even if the vacuum test is completed the operator shall check the test results and consider whether the test results are ac...

Page 62: ...message is displayed Push the confirm button to confirm the Successful message Proceed to chapter Opening the door and Unloading 8 6 2 Cycle Failed In the event of a failure at any stage the exhaust...

Page 63: ...oad Any failure means that the load is not sterile 8 7 Aborting a cycle It is possible to stop the cycle while the autoclave is operating Press the Stop button at any stage except exhaust of the proce...

Page 64: ...on for the failure An alternating buzzer signal will sound to notify the user Press the button to confirm the displayed message Warning The load has not completed the cycle therefore it is not sterile...

Page 65: ...default programs To utilize a customized program Have your dealer or service technician create a customized program This can be done by duplicating one of the preinstalled programs The new program bec...

Page 66: ...inting a specific cycle l On the Quick Option screen press the Settings icon then browse to Advanced options Handle cycles Cycles history The following screen is displayed with the status of the cycle...

Page 67: ...Press to receive the entire printout of the selected cycle history Page 60...

Page 68: ...r body over or under the door 3 Use the tray handle or wear heat resistant gloves to remove the load from the autoclave 4 After unloading visually inspect the load to ascertain that it is dry and that...

Page 69: ...n a new cycle before draining the waste water reservoir see Draining the Reservoirs in section 8 11 8 12 Draining the Reservoirs This procedure applies to the mineral free water reservoir left and to...

Page 70: ...ean water reservoir fill reservoir with distilled water until it reaches the full level Approximately 219 Ounces 6 5 liters The autoclave is now ready for use 8 12 1 Waste water draining Caution Waste...

Page 71: ...Daily Maintenance Caution Make sure the autoclave is not hot before cleaning it l Turn the unit on momentarily to allow the door to be opened Open the door unplug the autoclave again and proceed with...

Page 72: ...autoclave 9 4 Periodic Maintenance Caution Make sure the autoclave is not hot before cleaning it 1 Replace the air filter every 6 months or after 1000 cycles whichever comes first according to sectio...

Page 73: ...w in the new filter 5 Ensure the new filter is all the way in and seated properly Note Make sure that the arrow on the filter body points inwards toward the chamber Make sure that you don t bend the f...

Page 74: ...ide the autoclave chamber at the bottom far end to reach the filter open the autoclave chamber door remove the tray see below 2 Open the autoclave chamber door remove the tray 2 see above 3 Clean with...

Page 75: ...elf life Carefully un pack the new filter and examine it for any signs of damage Remove any protective packaging before inserting the filter into place Carefully Insert the new filter into the housing...

Page 76: ...er assembly 5 Screw the new Drain filter assembly P N CMT511 0048 to its place in the chamber bottom tighten it with the M14 wrench 6 Ensure the new filter is all the way in and seated properly 7 Plac...

Page 77: ...adequate information are authorized to serve the apparatus See tables below 10 1 Symbols Symbol Message Symbol Message Description Required Action if applicable This symbol is displayed when the door...

Page 78: ...hanges to the Good level symbol Good water level Waste water tank Informative symbol Alert Press to watch the alert description When cycle is selected it is highlighted in red The cycle succeeded mess...

Page 79: ...Chamber pressure ATM pressure 0 4 bar or ATM Pressure 0 1 bar Cancel I O card is not connected This message is displayed if I O card is disconnected both while cycle is running or not Low Temp This me...

Page 80: ...cannot reach atmospheric pressure 0 05 bar during the ending stage High Pressure Exhaust This message is displayed if the system cannot reach preset pressure within 10 minutes from the beginning of th...

Page 81: ...er Number of cycles since last periodical maintenance exceeded the cycle service counter parameter Or time elapsed exceeded the time service counter parameter Power Down This message is displayed if p...

Page 82: ...the digital value to micro siemens according to the attached table 3 Compare the value system parameter water quality reference default 10 4 if value is less than 10 show error Low Quality Water Set...

Page 83: ...e 2 Please switch OFF and ON machine s power switch If WIN application crash not start up Utility issue 3 Please switch OFF and ON machine s power switch If I O card disconnected during power on Time...

Page 84: ...ing on thermal paper roll or label roll l Two printers connected to the autoclave one loaded with thermal paper roll and the second printer is loaded with label roll 11 1 1 Printer Output The autoclav...

Page 85: ...with Cycle Ended For an aborted cycle Cycle Failed and the Error message are printed refer to Displayed Error Messages Symbols The printer can also print labels when loaded with label roll and printe...

Page 86: ...Page 79...

Page 87: ...alling the device tipping or dropping could cause damage 7 Make sure to follow the correct power rating and power type indicated on the marking label provided by the manufacturer 8 Please refer instru...

Page 88: ...ice Unpacking the printer 1 Carefully open the printer box 1 and remove the printer packing 2 Place the printer 2 on the table and remove the two tapes 3 3 Remove the rest of the box content which inc...

Page 89: ...oll or label roll on the printer roll compartment opening You can also connect two printers to the autoclave one loaded with thermal paper roll and the second printer loaded with label roll 1 Slide sw...

Page 90: ...5 Insert the paper under the two paper guides item 6 in figure 3 for the paper roll pull the paper to extend it beyond the printer Do the same for the label roll item 6 figure 4 Page 83...

Page 91: ...6 Push the printer cover down fig 5 until you can hear a click indicating that the cover is connected to the printer bottom Page 84...

Page 92: ...the 2 screws 3 to the adapter 2 Plug the adapter connected with the blue cable 8 to the printer adapter connection Tighten the 2 screws 4 To the printer 5 using screwdriver shown below 3 Connect the...

Page 93: ...able plug connector of cable 6 coming from the printer to the electrical power source on the wall 3 Turn on the printer power 11 8 Starting the printer 1 Press on the button in the front of the printe...

Page 94: ...start flashing 3 Ensure that the green bulb lights The printer will run and feed the roll until the end of calibration process approximately half meter for paper roll and 3 labels for label roll 11 9...

Page 95: ...on 3 Enter administration password Select from drop down list 4 Press Login Enter administration password Select from drop down list 5 Press on the quick option 6 Press on new 7 Press on system parame...

Page 96: ...label 1 9 If only the one printer is connected to the autoclave local 0 or printer 1 The following table gives the various printer possibilities Printer Type Local Only paper roll 6 0 Only Label roll...

Page 97: ...ge Autoclaves It uses one tablet from the package Cat CLE 096 0070 71 72 The tablet is composed from chemicals that are specifically designed for cleansing and removal of water deposit oxides and othe...

Page 98: ...2 Open the autoclave chamber door 3 Remove instruments and any load trays from the autoclave chamber 4 Place the trays and tray holder in the sink to be cleaned with a stainless steel Safe cleaner 5...

Page 99: ...gram Manual fill clean water tank To fill water in the reservoir lift the water reservoir cover and fill with clean water see below 9 Chamber Clean program Water tank clean waste 10 Select Chamber Cle...

Page 100: ...11 Chamber Clean program Start Cycle 12 Chamber Clean program Water tank alarm 13 Chamber Clean program set to the manual filling mode of the clean water tank Page 93...

Page 101: ...14 An alarm will appear while water tank is filling 15 Chamber Clean program Cleaning insert Water stage The process lasts approx one hour 16 Chamber Clean program Cleaning Keep stage Page 94...

Page 102: ...er approx 60 minutes the Chamber Clean process is completed The Chamber is clean and the following screen is displayed Chamber Clean program cycle confirm by operator 18 Wipe clean leftover residue Pa...

Page 103: ...O Admin for User Manual Level 1 Factory Code 021 PKKSD0F9MD Admin for User Manual Level 1 Factory Code 022 WG2Q1UBBY9 Admin for User Manual Level 1 Factory Code 023 03O6I6YUKL Admin for User Manual Le...

Page 104: ...042 XRCOEYV6AM Admin for User Manual Level 1 Factory Code 043 EW7PX1MNGB Admin for User Manual Level 1 Factory Code 044 HO7MM19C2Y Admin for User Manual Level 1 Factory Code 045 ZKYMO2HXHO Admin for...

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