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1. General Information

1.1

Manufacturer and US Official Correspondence

Information

T-Edge 10 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

1.2

Applicable Regulation and Quality Standards

The life cycle of Tuttnauer's T- Edge 10 is in compliance with the following
regulation and quality standards:

93/42/EEC, Council Directive, concerning medical devices

2014/68/EU, Directive, concerning pressure equipment.

2006/42/EC Machinery Directive.

2014/35/EU, Directive, Low Voltage Directive (LVD)

2014/30/EU, Electromagnetic compatibility.

2012/19/EU WEEE and EU Restriction of the use of certain hazardous
substances (RoHS Directive)

Canadian MDR (CMDR) SOR/98-282, consolidated.

ISO 9001Quality Management System.

EN ISO 13485 Quality Management System – Medical devices.

ISO 14001 environmental management system

EN ISO 14971 Medical devices – Application of risk management.

Chinese Regulations on Safety Technology for Pressure Vessel.

MEDDEV 2.12-1 Medical Devices Vigilance System

MEDDEV 2.12/2 Post Market Clinical Follow Up

MEDDEV 2.7.1 Rev 4 Clinical Evaluation

MEDDEV 2.5.2 Reporting of design changes of the quality system

ASME Code section I and section VIII. Div.I

ANSI/AAMI ST55 Tabletop steam sterilizers

IEC

61010- 1

Safety

Requirements

for electrical

equipment for

measurement control and laboratory use.

EN 61010- 2- 40 Safety requirements for sterilizers and washer-
disinfectors used to treat medical materials.

Page 1

Содержание AMS10-120-T

Страница 1: ...Sterilizer Models T Edge 10 Cat No MAN205 0502015EN Rev H 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 REF AMS10 120 T AMS10 120 W T Op...

Страница 2: ......

Страница 3: ...vacuum B and S Class Steam Sterilizer Models T Edge 10 REF AMS10 120 T AMS10 120 W T Cat No MAN205 0502015EN Rev H January 2021 Tuttnauer U S A Co Ltd 25 Power Drive Hauppauge NY 11788 U S A Tel 631 7...

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

Страница 5: ...ons 9 1 11 Device EnvironmentalInformation 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 THEDEVIC...

Страница 6: ...n 54 8 7 Aborting a cycle 55 8 8 Custom Programs 57 8 9 Cycles history 58 8 10 Opening the door and Unloading 60 8 11 Checking Waste Water Level 61 8 12 Draining the Reservoirs 61 9 PREVENTIVEAND SCHE...

Страница 7: ...face cables to the printer 84 11 7 Connecting power and interface cables 85 11 8 Starting the printer 85 11 9 Setting Printer definitions 86 12 CHAMBER CLEAN PROGRAM 89 12 1 General 89 General 89 12 2...

Страница 8: ...tromagnetic compatibility l 2012 19 EU WEEE and EU Restriction of the use of certain hazardous substances RoHS Directive l Canadian MDR CMDR SOR 98 282 consolidated l ISO 9001Quality Management System...

Страница 9: ...vided by enclosures IP Code l EN 61326 1 EMC Requirements for Electrical Equipment l IEC62304 A1 Medical Device Software Software life cycle processes l IEC 62366 1 Part1 Application of Usability Engi...

Страница 10: ...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 11: ...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 12: ...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 13: ...T edge10 Table top autoclave is designed for sterilization of medical and surgical goods such as wrapped and unwrapped solid hollow and porous loads used in dental and medical clinics first aid rooms...

Страница 14: ...implied 1 8 Warranty Statement The warranty registration must be completed and returned to our service departments within fourteen 14 days of purchase or the warranty will be void Our American Repres...

Страница 15: ...method and retain packing materials until the unit has been inspected Mechanical inspection involves checking for signs of physical damage such as scratched panel surfaces broken knobs damaged gasket...

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

Страница 17: ...s than 3 percent 1 10 3 Device Properties Table 2 Properties of the device Property Dimension External size Width 19 7 50cm Height 19 49 cm Depth 22 8 58 cm supporting common install base carry a 23 6...

Страница 18: ...float 128 Ounces 3 8lit Min water volume 33 8 Ounces 1lit The volume used by the sterilization cycle load having the highest steam consumption Recorded 27 Ounces 800ml were required to sterilize full...

Страница 19: ...ns supply 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 inl...

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: ...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 WIR040 0232 Po...

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 AMS10 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: ...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 165 lbs 75Kg or more 3 Check and...

Страница 29: ...r 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 a manner not specified by the man...

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: ...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 Reservoir with water meeting the quality specs see Water Q...

Страница 32: ...ve Before starting the autoclave we recommend that you check the following 1 In the Quick Option screen press the Info option 2 Select the Version information 3 The Version information is displayed Fo...

Страница 33: ...rn to the Info screen 5 Select the Play tutorial option to watch the T EDGE 10 Instructional Video 6 The T EDGE 10 Instructional Video can be accessed in the link below https tuttnauer com t edge10 en...

Страница 34: ...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 35: ...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 these materials l Load items within...

Страница 36: ...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 only dirt Dirt spots on an instrument may be an indication that the autoclave n...

Страница 37: ...se 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 instrument to insulate it from other instruments...

Страница 38: ...F bottom Switch located on the rear panel of the autoclave see the rear view Turn on the ON OFF switch mounted under the cover on the front of the autoclave see below 7 2 Filling Water Cautions In the...

Страница 39: ...ater level icon appears when the water level in the reservoir is full See the filling procedure in section 7 3 and Draining the Reservoir procedure in section 8 11 When this icon appear do not fill wa...

Страница 40: ...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 41: ...The screen below displays a full clean water tank 7 4 See the requirements concerning Water Quality in Section 1 12 Page 34...

Страница 42: ...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 43: ...A for types of sterilization cycles Table B provides the T EDGE 10 Class B sterilization programs Table C provides the T EDGE 10 Class S sterilization programs Table A Types of sterilization cycles Cl...

Страница 44: ...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 45: ...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 46: ...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 47: ...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 40...

Страница 48: ...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 41...

Страница 49: ...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 50: ...perature Momentary temperature 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 Water full The Water is full in the reser...

Страница 51: ...xt 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 sterilization program and enables modifying...

Страница 52: ...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 confirm button Showing Class S In any case if the do...

Страница 53: ...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 54: ...e 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 War...

Страница 55: ...Note For the results of the cycle see description in section 8 5 Page 48...

Страница 56: ...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 57: ...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 50...

Страница 58: ...of available Sterilization and Test Programs CLASS B Remark The cycle time reported is 2 2 lbs 1kg Solid Warm Start Notes The Unwrapped sterilization program can be used for sterilizing lumen device...

Страница 59: ...ime reported is 2 2 lbs 1kg Solid Warm Start 8 5 3 Maximum Load Weight per Load type Table 11 Maximum Load Weights Load type Maximum Load Weight Suitable for programs Textile porous 3 lbs 1 5kg Wrappe...

Страница 60: ...uilibrium After the 5 minutes have elapsed the cycle history record records the pressure that is referred to as P2 At this point the test begins and lasts 10 minutes At the end of the test the cycle h...

Страница 61: ...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 62: ...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 63: ...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 64: ...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 65: ...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 66: ...Press to receive the entire printout of the selected cycle history Page 59...

Страница 67: ...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 68: ...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 69: ...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 70: ...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 71: ...soft cloth l Clean the Drain filter of the 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...

Страница 72: ...Disconnect the pipe 3 Connect the new filter 4 Screw 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 to...

Страница 73: ...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 74: ...s not exceeded the maximum 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 th...

Страница 75: ...h 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 way...

Страница 76: ...elow 10 1 Symbols Symbol Message Symbol Message Description Required Action if applicable This symbol is displayed when the door is open Note The inherent safety feature of the machine enables the use...

Страница 77: ...ert Press to watch the alert description When cycle is selected it is highlighted in red The cycle succeeded message and symbol are displayed when the cycle ends successfully The cycle Failed message...

Страница 78: ...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 79: ...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 80: ...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 81: ...g sensor 2 Translate 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 Lo...

Страница 82: ...itch Utility issue 3 Please switch OFF and ON machine s power switch If I O card disconnected during power on Time jumped during the cycle If main system clock changed during the cycle No user log in...

Страница 83: ...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 84: ...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 85: ...Page 78...

Страница 86: ...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 87: ...SB communication cable 6 electrical power cable 7 CD 5 adapter 8 blue cable 9 and the printer instructions 4 Note the USB communication cable or other cables may come in another additional box 11 4 Op...

Страница 88: ...with thermal paper roll and the second printer 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 pu...

Страница 89: ...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 82...

Страница 90: ...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 83...

Страница 91: ...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 92: ...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 93: ...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 94: ...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 95: ...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 96: ...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 Tuttnauer...

Страница 97: ...n the sink to be cleaned 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 figu...

Страница 98: ...ram Manual fill clean water tank To fill water in the reservoir lift up the water reservoir cover and fill with clean water see below 9 Chamber Clean Program Water tank clean waste 10 Select Chamber C...

Страница 99: ...11 Chamber Clean Program Start Cycle 12 Chamber Clean Program Water tank alarm 13 Chamber Clean Program Set manual mode fill clean water tank Page 92...

Страница 100: ...ram Stage Cleaning insert water The chamber clean process last 45 minutes The warming up to 176 F and hold for 10 minutes at 176 F This stage uses 500ml of water from the clean water reservoir Exhaust...

Страница 101: ...r 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 operato...

Страница 102: ...PCO 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...

Страница 103: ...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 104: ...Cat No MAN205 0502015EN Rev H COPYRIGHT...

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