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ANSI/AAMI ST55:2016 Tabletop steam sterilizers

IEC 61010-1 3.1 Edition, January 2017 Safety Requirements for electrical

equipment for measurement control and laboratory use.

EN 61010-2-40: 2015 Safety requirements for sterilizers and washer-

disinfectors used to treat medical materials.

EN ISO 15223-1: 2016 Symbols for use in the labeling of medical devices.

EN 1041: 2008 + A1:2014 Information to be supplied by the manufacturer

of medical devices

EN 60529:1992 + A2:2013 Degrees of protection provided by enclosures

(IP Code)

EN 61326-1: 2013 for EMC Requirements for Electrical Equipment.

IEC 62304:2014 + A1: 2015

– Medical Device Software – Software life

cycle processes.

EN 62304:2006/AC:2008

– Medical Device Software – Software life cycle

processes.

IEC 62366-1: 2015

– Part1: Application of Usability Engineering to Medical

Devices

EN 62366:2008 - Application of Usability Engineering to Medical Devices

ANSI/AAMI ST55:2016

1.2.1

And in consideration with:

FDA QSR 21 CFR part 820 & part 11

Содержание AMS10-230-T

Страница 1: ...AMS10 230 T AMS10 230 W T Cat No MAN205 0502005EN Rev D July 2020 Tuttnauer Ltd Har Tuv B Industrial Zone P O Box 170 Beit Shemesh 9910101 Israel Tel 972 2 9904611 Fax 972 2 9904730 Tuttnauer U S A C...

Страница 2: ...2 Web site http www tuttnauerUSA com...

Страница 3: ...ns 13 1 11 2 T Edge10 fit into sterilization center cabinet recommended dimensions 14 1 11 3 Device Properties 14 1 11 4 Device Electrical Data 15 1 11 5 Utility Requirements 15 DEVICE ENVIRONMENTAL I...

Страница 4: ...ycle Succeeded 51 8 5 2 Cycle Failed 52 ABORTING A CYCLE 53 OPENING THE DOOR AND UNLOADING 54 CHECKING WASTE WATER LEVEL 55 DRAINING THE RESERVOIRS 55 8 9 1 Waste water draining 56 9 PREVENTIVE AND SC...

Страница 5: ...trical Data 15 Table 4 Utility Requirements 15 Table 5 Water Quality 16 Table 6 Safety Warnings and Precautions 18 Table 7 Device Package 20 Table 8 Front View 21 Table 9 Rear View 22 Table 10 Home sc...

Страница 6: ...ent 2006 42 EC Machinery Directive 2014 35 EU Directive Low Voltage Directive LVD 2014 30 EU Electromagnetic compatibility 2012 19 EU WEEE and EU 2017 2102 Restriction of the use of certain hazardous...

Страница 7: ...ation to be supplied by the manufacturer of medical devices EN 60529 1992 A2 2013 Degrees of protection provided by enclosures IP Code EN 61326 1 2013 for EMC Requirements for Electrical Equipment IEC...

Страница 8: ...efore use IP31 Ingress Protection European compliance Mark of compliance with the European Medical Device Directive Number xxxx identifies the Notified Body that performed the examination European com...

Страница 9: ...ized control unit ensures a fully automatic sterilization cycle control and monitoring of physical parameters and a clear documentation of the sterilization cycle Drying is performed with the door clo...

Страница 10: ...100 240V A barcode printer is an optional addition to the autoclave The device features built in memory to record up to 999 sterilization cycles These can be exported to a USB device to be transferre...

Страница 11: ...installation or application nor shall it extend to autoclaves that have been repaired or altered outside the factory without prior authorization from Tuttnauer Tuttnauer s obligation is limited to the...

Страница 12: ...is found note the location with respect to the autoclave and check that area of the autoclave carefully once it is fully unpacked Observe packing method and retain packing materials until the unit ha...

Страница 13: ...Specifications 1 11 1 Device Overall Dimensions Front view Side view Top View Dimensions Front view W 18 480mm H 22 580mm 21 536mm D 536mm Side view W 18 580mm 21 536mm Top view W 18 480mm D 22 580mm...

Страница 14: ...2kg Maximum load per tray Unwrapped 2 67 lbs 1 2kg Wrapped 1 6 lbs 0 72kg aximum Solid load Unwrapped 13 lbs 6kg Wrapped 7 7 lbs 3 5kg Maximum textile load 3 3 lbs 1 5kg Tray dimensions 16 6 x7 4 x0 8...

Страница 15: ...temp of 80 C Power supply 1 phase 230VAC 10 60Hz 10 A Recommended circuit breaker 16A Table 4 Utility Requirements According to the local network Caution In order to avoid any injury by electrical ha...

Страница 16: ...0 1mg l Cadmium 0 005 mg l 0 005 mg l Lead 0 05 mg l 0 05 mg l Rest of heavy metals except iron cadmium lead 0 1 mg l 0 1 mg l Chloride Cl 2 mg l 0 1 mg l Phosphate 0 5 mg l 0 1 mg l Conductivity at 2...

Страница 17: ...water is strictly forbidden Please consult a water specialist Note We recommend testing the water quality once a month The use of water for autoclaves that does not comply with the table above may ha...

Страница 18: ...ces 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 device is operati...

Страница 19: ...The owner of the autoclave is responsible to perform the maintenance operations Notify the person in charge immediately of any deviation from the normal functioning of the device Protective equipment...

Страница 20: ...0001 Wire Tray holder for trays or Cassettes 1 TRH511 0004 tray stoppers to be assembled on tray holder 8 CMT240 0002 Tray Handle 1 PIP411 0042 Tube for Reservoir Drain 2 PIP511 0029 Tube for Auto re...

Страница 21: ...Touch screen 7 Door switches 2 On off switch 8 Air filter 3 Chamber Door 9 USB socket 4 Door Gasket 10 Door Handle 5 Mineral free left and waste water right reservoir drains Chamber 11 Mineral free wa...

Страница 22: ...7 Mineral free inlet available in AMS10 230 W T 3 Cut off Thermostat 8 Safety valve 4 Circuit breaker on off switch 9 Aeration Ventilation opening 5 Power socket Table 9 Rear View Warning Mind the Po...

Страница 23: ...he 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 165 lbs 75Kg or more 3 Check and verify that the dimens...

Страница 24: ...only in the manner specified in the manual If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Connections to Utility Suppli...

Страница 25: ...d on the bottom left side of the front panel see the front view 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...

Страница 26: ...vice manufacturer relating adequate and most effective cleaning method and cleaning agents Instruments which are composed of several components shall be dismantled Disinfection is the next step It is...

Страница 27: ...te sterilization drying Make sure that all instruments remain apart during the sterilization cycle Surfaces that are hidden because items are covering other items will not be exposed to the steam and...

Страница 28: ...moval of the spot reveals pitting then the spot is most likely rust Rust spots on an instrument are not uncommon on inexpensive instruments It may also be an indication that the instruments were rinse...

Страница 29: ...o the socket on the rear panel of the 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...

Страница 30: ...ll appear Proper Water level icon appears when the water reservoir is properly filled See the filling procedure below and draining procedure 8 9 The water level icon appears when the water level in th...

Страница 31: ...in the reservoir Note Use only water having the characteristics stated in Water Quality Using tap water will clog the system and invalidate the manufacturer s guarantee To fill water in the reservoir...

Страница 32: ...n Section 1 14 Setting Date and Time Note The Initial log in including setting of drying time as well as other initial parameters will be performed only by a qualified technician upon installation On...

Страница 33: ...ate and Time icon to open the Set Date and Time screen This quick option enables the operator to set the machine date and time Select day month and year as depicted After adjusting the date and time t...

Страница 34: ...34 This page is left intentionally blank...

Страница 35: ...able1 for types of sterilization cycles Table 2 provides the T EDGE 10 Class B sterilization programs Table 3 provides the T EDGE 10 Class S sterilization programs Table 1 Types of sterilization cycle...

Страница 36: ...F 273F 3 Pre Post Vac Unwrapped Delicate 250F 250F 4 Pre Post Vac Wrapped Delicate 250F 250F 5 Chamber Clean 6 Bowie and Dick 273 F 7 Vacuum test Table 3 Class S sterilization cycles Cycle Name Steril...

Страница 37: ...ill ask you for the autoclave serial number In return Tuttnauer will provide you with a code password After entering the new code password by the customer user the autoclave will contain now the class...

Страница 38: ...38 3 Press on the required class type 4 Enter Password 5 Click on set 6 Class setting is in progress press OK...

Страница 39: ...ass B and the screens displayed will have a class B identification Note the Class B sign are on screen header The entire autoclave is now in class B system a sample of the screens after the conversion...

Страница 40: ...40 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 B Entering the code password is required...

Страница 41: ...urrent 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 on Additional progr...

Страница 42: ...or condition Door is locked 11 Wrapped Pouches 273F Wrapped Pouches 273F sterilization program 12 Side arrow right Paging forward to the next program will display the next screen item 17 and 18 13 Wra...

Страница 43: ...zation 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 confirm button Showing Class S In any case if the door is not locked i...

Страница 44: ...not loose and clean 2 Load the autoclave properly see chapter 6 3 Choose the appropriate sterilization program Note The program can only be selected when the door is open 4 The selected program will b...

Страница 45: ...h Pushing the door gently Turning the handle clockwise while pushing the door until it comes to the closed position then releasing the handle When the door is closed the open door symbol is replaced w...

Страница 46: ...iption see Sterilization Cycle Description Warning Do not remove the top plastic cover during a running cycle Hot water steam may exit After pressing start the sterilization process starts Image 3 scr...

Страница 47: ...47 Showing the time left until the end of the process...

Страница 48: ...in paragraph 8 5 Program test description Program icon name Program test description Sterilization temperature Sterilization time Chamber temperature Chamber pressure System status Name of stage Erro...

Страница 49: ...1 99 Unwrapped Instruments Unwrapped Solid immediate use only S 4 Wrapped Delicate 250F 250 F 20 35 default Range 30 99 Wrapped Instruments wrapped solid Textile fabric packs porous for storage B 6 Bo...

Страница 50: ...ng performed with the door closed by pulling vacuum and using the accumulated heat in the chamber and the load to remove leftover moisture from the instruments and wraps 8 4 4 Description of the Vacuu...

Страница 51: ...team is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure Drying stage heating of chamber followed by a vacuum break air inlet to remove leftover moisture from t...

Страница 52: ...pened to release pressure from the chamber the message Fail and a relevant failure message will be displayed on the screen Warning The load has not completed a sterilization cycle therefore it is not...

Страница 53: ...peration If the cycle is aborted the load is not sterile A fail message will be displayed with an error message explaining the reason for the failure An alternating buzzer signal will sound to notify...

Страница 54: ...at resistant gloves to remove the load from the autoclave 4 After unloading visually inspect the load to ascertain that it is dry and that sterilization indicators have made the required color change...

Страница 55: ...a new cycle before draining the waste water reservoir see Draining the Reservoir 8 9 Draining the Reservoirs This procedure applies to the mineral free water reservoir left and to the waste water rese...

Страница 56: ...ste water 5 If the drained reservoir is the clean water reservoir fill reservoir with distilled water until it reaches the full level Approximately 6 5 liters The autoclave is now ready for use 8 9 1...

Страница 57: ...hnician can be requested by either calling your dealer or Tuttnauer Europe Daily Maintenance Caution Make sure the autoclave is not hot before cleaning it Turn the unit on momentarily to allow the doo...

Страница 58: ...escale the chamber If the autoclave is only used occasionally drain the water from the mineral free water reservoir once a week and refill with fresh mineral free water or distilled water Once a week...

Страница 59: ...ns Before proceeding make sure that the electric cord is disconnected and there is no pressure in the chamber Use scissors to open the filter bag and not sharp blades or pointed instrument Check that...

Страница 60: ...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 filter pipe when reattaching it Note It is reco...

Страница 61: ...ated inside 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 Cl...

Страница 62: ...imum shelf 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...

Страница 63: ...wrench 4 Remove the old Drain filter 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...

Страница 64: ...ols Symbol Message Symbol Message Description Required Action if applicable Sym 100 This symbol is displayed when the door is open Note The inherent safety feature of the machine enables the user to c...

Страница 65: ...ed either due to intended cycle abort action by the user or due to a run time error Try Perform a new cycle in order to sterilize the load Error messages Troubleshooting Req ID Message Description Msg...

Страница 66: ...conds during sterilization cycle Msg 190 High Temp Ending This message is displayed if the system cannot reach the required temperature in the chamber within 10 minutes Msg 200 Heat Time Error This me...

Страница 67: ...e atmospheric pressure after 10 minutes Msg 330 Canceled Msg 340 If the water level is low in the clean water reservoir and not sufficient for at least one cycle this symbol will be displayed Mineral...

Страница 68: ...ar in the UI Msg 420 Low Quality Water 1 Read the water level from analog sensor 2 Translate the digital value to micro siemens according to the attached table 3 Compare the value system parameter wat...

Страница 69: ...switch OFF and ON machine s power switch If I O card disconnected during power on Msg 500 Time jumped during the cycle If main system clock changed during the cycle Msg 510 No user log in If CFR 11 o...

Страница 70: ...1Printer Output The autoclave is equipped with a character printer which prints a detailed history of each cycle performed This can be used for the record or for subsequent consideration The printing...

Страница 71: ...71...

Страница 72: ...nstalling 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 ins...

Страница 73: ...Place the printer 2 on the table and remove the two tapes 3 3 Remove the rest of the box content which includes USB communication cable 6 electrical power cable 7 CD 5 adapter 8 blue cable 9 and the...

Страница 74: ...ing the printer body to its cover 1 on each opposite sides of the printer 2 Pull the two handles left and right 2 simultaneously together forward as shown by the arrows in figure 1 3 The top printer c...

Страница 75: ...rinter loaded with label roll 1 Slide switch item 1 forward shown in fig 2 it will allow to move the roll holders 2 apart as shown in fig 1 below allowing to put the paper roll on the holders 2 Adjust...

Страница 76: ...ll the paper to extend it beyond the printer Do the same for the label roll item 6 figure 4 6 Push the printer cover down fig 5 until you can hear a click indicating that the cover is connected to the...

Страница 77: ...the printer adapter connection Tighten the 2 screws 4 To the printer 5 using screwdriver shown below 3 Connect the Power cable 6 to the printer back port 1 Adapter 2 RC 232 Output Port blue cable 3 R...

Страница 78: ...e cables 1 Connect the RC 232 Output Port blue cable 6 to the back of the autoclave 4 2 Connect the power cable plug connector of cable 6 coming from the printer to the electrical power source on the...

Страница 79: ...back Step 1 and 2 shall be done simultaneously 2 Switch on the printer power 1 at the printer back keep pressing the finger in step 1 until the red light bulb in front start flashing 3 Ensure that the...

Страница 80: ...he login procedures for new user 1 Press on the quick options menu 2 Press on icon 3 Enter administration password Select from drop down list 4 Press Login Enter administration password Select from dr...

Страница 81: ...lect for label roll 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...

Страница 82: ...des and other sediments found in steam sterilizers The tablet material is a combination of acidic salts and additional cleaning materials Use one prepacked chamber clean tablet for all T Edge10 Tuttna...

Страница 83: ...with a stainless steel Safe cleaner 5 Place one 6g cleaning tablet 1 from the tablet packing 2 inside the sterilization chamber at the back bottom of the cold chamber see figure below Under the 132 C...

Страница 84: ...84 8 Chamber Clean Program Manual fill clean water tank 9 Chamber Clean Program Water tank clean waste...

Страница 85: ...85 10 Select Chamber Clean Program 11 Chamber Clean Program Start Cycle...

Страница 86: ...86 12 Chamber Clean Program Water tank alarm 13 Chamber Clean Program Set manuel mode fill clean water tank...

Страница 87: ...ean program Stage Cleaning insert water The chamber clean process last 45 minutes The warming up to 80 C and hold for 10 minutes at 80 C This stage uses 500ml of water from the clean water reservoir E...

Страница 88: ...hamber clean program Stage Cleaning keep 17 After 45 minutes the chamber clean process is completed the chamber is clean and the following screen is displayed Chamber Clean Program cycle confirm by op...

Страница 89: ...l Level 1 Factory Code 018 LYBVQXMB4X Admin for User Manual Level 1 Factory Code 019 8JDZPNRA4W Admin for User Manual Level 1 Factory Code 020 GPAQKFZPCO Admin for User Manual Level 1 Factory Code 021...

Страница 90: ...or User Manual Level 1 Factory Code 040 KJCLC48NKH Admin for User Manual Level 1 Factory Code 041 QI3S1S9S2U Admin for User Manual Level 1 Factory Code 042 XRCOEYV6AM Admin for User Manual Level 1 Fac...

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