Tuttnauer AMS11-120-T Скачать руководство пользователя страница 10

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ASME Code

Section I and Section VIII. Div. I

PED

2014/68/EU

Chinese Regulations

Special Equipment Licensing Office

EN 13060:

Small Steam Sterilizer

ANSI/AAMI/ST55:

Tabletop Steam Sterilizer

ISO 17665:

Sterilization of health care products –
Moist heat

ANSI/AAMI/ST79:

Comprehensive guide to steam
sterilization and sterility 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:

Safety requirements for electrical
equipment for measurement, control, and
laboratory use – Part 2-040: Requirements
for sterilizers and washer-disinfectors
used to treat medical materials

EN 613261-1:

EMC Requirements for Electrical
Equipment

IEC 62304:

Medical Device Software – Software life
cycle processes

Page 3

Содержание AMS11-120-T

Страница 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...

Страница 2: ......

Страница 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...

Страница 4: ...https www tuttnauerusa com...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 86: ...Page 79...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 105: ...Cat No MAN205 0502003EN Rev C COPYRIGHT...

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