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Specifications

A

STERRAD

®

100NX

®

User’s Guide

105

Medical Device
Requirements and
Guidelines

Medical Device Directive 2007/47/EC

IEC/EN 61010-1: Safety Requirements For Electrical Equipment For
Measurement, Control, And Laboratory Use – Part 1: General Requirements

EN 61010-2-040: Safety Requirements for Electrical Equipment, Control and
laboratory Use. Particular requirements for sterilizer and washer-disinfectors used
to treat medical devices.

IEC 60601-1: Medical Electrical Equipment – Part 1: General Requirements For
Safety (Japan Requirement)

EN 60601-1-2: Medical Electrical Equipment - electromagnetic Compatibility -
Requirements and Tests.

ANSI/AAMI/ISO 14937: Sterilization Of Health Care Products – General Criteria
For Characterization Of A Sterilizing Agent And Development, Validation, And
Routine Control Of A Sterilization Process

CAN/CSA C22.2 No. 61010-1.
UL 61010-1.

Medical Device
Agencies

US: FDA (Food and Drug Administration)

EU: TUV Product Service (ASP’s Notified Body)

Japan: MHLW (Ministry of Health, Labor and Welfare)

Canada: TPP (Therapeutic Products Programme)

Australia: TGA (Therapeutic Goods Administration)

DRAFT

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Содержание Sterrad 100NX

Страница 1: ...STERRAD 100NX Sterilization System User s Guide Ref 99994 M 99994_03 May 2014 D R A F T...

Страница 2: ...of E I du Pont de Nemours and Company Radel is a registered trademark of Solvay SA Kraton is a registered trademark of Kraton Polymers LLC Santoprene is a trademark of ExxonMobil Corporation Ultem is...

Страница 3: ...tion 15 Load Weight Requirements 15 Cycles and Materials Processing 18 Recommended Materials 22 Thermoplastics 22 Thermoplastic Elastomers 22 Thermosetting Elastomers 23 Glass 23 Metal 23 Items Not To...

Страница 4: ...ress 42 Canceling a Cycle 43 Cycle Completed 45 Processing a Sterilized Load 46 Inspecting Chemical Indicators 46 Processing Biological Indicators 46 Chapter 5 Troubleshooting 49 Running Diagnostics 4...

Страница 5: ...ory Stick 72 Rebooting the System 73 Sterilizer Disposal 73 Chapter 8 Reports and Files 75 Displayed Reports 75 Cycle History 75 Printed Reports 77 Short Report 77 Parametric Report 77 Long Report 77...

Страница 6: ...User 90 Upload User Data 91 Steps to Upload a User Database 92 Cassette Functions 93 Dispose Cassette 94 Peroxide Clearance 95 Network 96 Diagnostics 96 Diagnostic Tests 97 Service Functions 97 File M...

Страница 7: ...ntion to the chapter featuring Access Levels and Supervisor Level Tasks This chapter describes tasks and options that are only available through Supervisor Level access Intended Use The STERRAD 100NX...

Страница 8: ...lizer can be used for both metal and nonmetal devices and can also sterilize instruments that have difficult to reach diffusion restricted spaces such as hinges on forceps Refer to the Safety Informat...

Страница 9: ...removing items from the sterilizer following a cancelled cycle or if any moisture is noted on items in the load following a completed cycle WARNING HYDROGEN PEROXIDE IS AN OXIDIZER Hydrogen peroxide...

Страница 10: ...y for treatment advice Have the person drink plenty of water if the person is able to swallow Do not give anything by mouth to an unconscious person Do not induce vomiting unless instructed to do so b...

Страница 11: ...ntinue use of the STERRAD System until the system is repaired Personnel should avoid working in the room until the mist has cleared Please note that all STERRAD Sterilizers should be used and installe...

Страница 12: ...ith the chamber walls the doors or the electrode Contact with the walls doors or electrode could damage the sterilizer or the metal objects CAUTION RISK OF DAMAGE TO LOAD VENTING CAPS Take special car...

Страница 13: ...STERRAD 100NX Sterilizer is intended for use in the electromagnetic environment specified below Assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guid...

Страница 14: ...y Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interferen...

Страница 15: ...inted in the text in bold Warnings indicate events or conditions that can result in serious injury or death Cautions indicate events or conditions that can result in severe damage to the equipment Not...

Страница 16: ...t Corrosive chemical present Use personal protective equipment Oxidizing chemical present Avoid exposure contact or ingestion Use personal protective equipment WEEE Symbol Toxic chemical present Avoid...

Страница 17: ...load to be sterilized should not exceed the load requirements for the specific cycle If you have questions or if you are in doubt about the materials in your devices contact the medical device manufa...

Страница 18: ...edical devices An inside diameter of 1 mm or larger and a length of 1000 mm or shorter can be processed in the STERRAD 100NX Sterilizer STANDARD cycle DUO Cycle Processing Medical devices including ma...

Страница 19: ...ng most flexible endoscopes with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer FLEX cycle Single channel polyethylene and Teflon polytetrafluoroethylene flexi...

Страница 20: ...ter includes cycle information regarding recommended items materials and some typical devices that can be sterilized in each of the cycles on the STERRAD 100NX Sterilizer Please refer to these pages w...

Страница 21: ...Load Preparation 3 STERRAD 100NX User s Guide 19 D R A F T...

Страница 22: ...3Load Preparation 20 STERRAD 100NX User s Guide D R A F T...

Страница 23: ...Load Preparation 3 STERRAD 100NX User s Guide 21 D R A F T...

Страница 24: ...have limited life after repeated sterilization Please contact your ASP Representative for more information Information may also be obtained from the device manufacturer Thermoplastics Ethylvinyl Aceta...

Страница 25: ...iquids Items made of materials that contain cellulose such as cotton paper or cardboard linens huck towels gauze sponges or any item containing wood pulp Paper instrument count sheets or lot stickers...

Страница 26: ...S Cycle Items made of Kraton cannot be processed in the EXPRESS Cycle Items made of Polyurethane cannot be processed in the EXPRESS Cycle Items with mated Delrin surfaces cannot be processed in the EX...

Страница 27: ...s for flaws or damage prior to packaging Items with flaws or damage should be replaced or repaired before using Note Periodic careful inspection of items after repeated exposure to disinfectant cleane...

Страница 28: ...re that instruments are completely dry before they are processed in the STERRAD sterilizer may result in residual hydrogen peroxide being present on the surface of the load after the cycle is complete...

Страница 29: ...n the load Tray Mats Instrument trays should only be padded with STERRAD Instrument Mats or polypropylene sterilization wrap Never use linen cellulose or any materials listed in the Items Not To Be Pr...

Страница 30: ...follow the Instructions for Use provided by the rigid container manufacturer Verify that the rigid containers are cleared for use in each sterilization cycle Remember the following Do not stack instr...

Страница 31: ...dicator strips or chemical indicator tape follow the Instructions for Use that accompany these items as you prepare the load Place STERRAD Chemical Indicator Strips inside trays and Tyvek pouches or f...

Страница 32: ...o the load DUO Cycle A maximum of 2 flexible endoscopes can be processed per load with or without silicone mats You can also process 1 flexible endoscope with its light cord and a camera CAUTION RISK...

Страница 33: ...t be turned off during warm up 3 Touch Screen to Start appears on the display when the sterilizer is ready for use Biological Indicators Biological indicators are an important method of confirming tha...

Страница 34: ...touch the Touch Screen to Start screen the sterilizer displays the Operator Login screen Figure 1 Operator Login Screen 1 Touch the Operator field The cursor appears in the field Note Operator and Pas...

Страница 35: ...ems can be typed into the screen or selected from a predefined list of items This information is stored and printed on a cycle report It can also be transferred to a host computer over a network conne...

Страница 36: ...return to the keyboard entry fields or to use a barcode scanner Cycle Notes Note If your sterilizer has been configured not to require cycle notes this screen will not appear The Cycle Notes screen al...

Страница 37: ...ry is complete touch the Done button 4 If conditions exist which prevent a sterilization cycle from starting e g no cassette hydrogen peroxide monitor is blocked etc a message is displayed on the scre...

Страница 38: ...stops immediately You must use the touch screen to open the door 1 Open the active chamber door by pressing the Open Door foot pad or by touching Open Door on the display and place your load on the sh...

Страница 39: ...is centered on the shelves and that the shelves are centered in the chamber Figure 6 The Load Should NOT Touch the Electrode 3 Do not allow any part of the load to touch the electrode the back wall o...

Страница 40: ...d for DUO and FLEX Cycle Processing 5 When you are finished loading the chamber close the door by tapping the foot pad or pressing the Close Door button on the touch screen 6 If a message requesting t...

Страница 41: ...nts for the EXPRESS Cycle Only the bottom shelf of the STERRAD 100NX Sterilizer should be used when processing loads in the EXPRESS Cycle The following figure shows a correctly placed load Figure 10 L...

Страница 42: ...nsert New Cassette if a new cassette is required if the cassette in the sterilizer is expired or if there is no cassette installed in the sterilizer Follow the instructions in the next section to inse...

Страница 43: ...hen the current operator is finished using the sterilizer and the option is enabled When Logout is selected you must re login to use the sterilizer Cycle History displays the Select Cycle History scre...

Страница 44: ...Cassette into the Slot 6 After a slight pause the sterilizer pulls the cassette through the slot and the slot door closes Cassette loading is now complete Cycle in Progress When you touch the Start Cy...

Страница 45: ...he name of the stage A moving bar graph also displays the percent of the cycle that is complete For details about the current stage information refer to the printouts in the Reports and Files chapter...

Страница 46: ...TERRAD Chemical Indicator Strips and STERRAD SEALSURE Chemical Indicator Tape If a biological indicator was used in the canceled load the previously used biological indicator must be discarded and a n...

Страница 47: ...ile for the just completed cycle 2 Touch the Done button to proceed Processing a Sterilized Load When you touch the Done button how the sterilizer responds depends upon the configuration of your steri...

Страница 48: ...in a timely manner Refer to the cycle completion flowcharts for additional information Inspecting Chemical Indicators After ensuring that the chemical indicators exhibit the correct color change and t...

Страница 49: ...Operation 4 STERRAD 100NX User s Guide 47 Cycle Completion Flowchart D R A F T...

Страница 50: ...4Operation 48 STERRAD 100NX User s Guide STERRAD CYCLESURE 24 Biological Indicator Flowchart D R A F T...

Страница 51: ...are messages that are displayed by the system The messages are listed in alphabetical order Some messages do not require action on your part and are merely statements of the system status Other messa...

Страница 52: ...ble there is no remedy available that you may safely perform Call your ASP Representative for further action If this message appears Do this Cannot Dispose Cassette Run Diagnostics The cassette did no...

Страница 53: ...V lamp is being adjusted Wait 5 minutes for adjustment to be completed H2O2 Bulb Warming Up Please Wait No action needed H2O2 Bulb Detector Fault H2O2 detector malfunction Run diagnostics H2O2 Curve A...

Страница 54: ...stant latex PVC vinyl or nitrile gloves whenever handling a load after a cycle cancellation Hydrogen peroxide liquid may be present on the load or in the chamber Load May Contain H2O2 Residual peroxid...

Страница 55: ...ile gloves whenever handling a load after a cycle cancellation Hydrogen peroxide liquid may be present on the load or in the chamber Pressure Check Failed Load is absorbing too much peroxide Remove ab...

Страница 56: ...to Open One Second Data File Replace the PCMCIA card with a new one UV Path Is Blocked Open Door And Clear Pathway Object is blocking the UV path Verify that the shelves and or the load are not blocki...

Страница 57: ...lizer This guide contains detailed instructions for each cycle Make sure you understand the differences in the cycles and what types of instruments can be sterilized in each cycle Figure 17 Select Cyc...

Страница 58: ...our left front side of the sterilizer The I O interface is located on the right your right front side of the sterilizer See the sections on Data Transfer and Rebooting the System for locations of the...

Страница 59: ...the active side both doors cannot be opened at the same time Cassette The cassette contains sealed capsules of hydrogen peroxide solution Each cassette has coded information that provides displayed de...

Страница 60: ...splays a message indicating that the box must be replaced The cassette disposal box must be closed to permit safe disposal of cassettes Refer to the Maintenance chapter for additional information Figu...

Страница 61: ...erilization The chamber walls and doors contain heaters that keep the chamber interior warm during operation When the chamber door s are closed a vacuum tight seal is created allowing the chamber atmo...

Страница 62: ...information on a roll of thermal paper The printer features easy drop in paper loading and requires no ink cartridges The system is also designed to interface to a second external printer that is USB...

Страница 63: ...lowing figure shows a typical data entry screen The typewriter keys input the indicated character each time a key is touched Touch the screen to move the cursor from place to place The load list can b...

Страница 64: ...tion buttons are shown in the following table Button Function Done Touch this button to indicate that you are finished using the screen Back Touch this button to return to a prior screen View Touch th...

Страница 65: ...s the warranty Automatic Maintenance The adjustment of the hydrogen peroxide monitoring lamp is performed automatically by the sterilizer software The user does not have to perform any task to start t...

Страница 66: ...be cleaned only when necessary This chapter provides step by step instructions on how to perform these maintenance tasks Information on inserting a cassette box follows the disposal section Disposing...

Страница 67: ...dual hydrogen peroxide that may be present in the cassettes 1 Open the cassette access door Pull the tab on the cassette disposal box to more easily slide it completely out Figure 25 Open the Access P...

Страница 68: ...is on the Left 5 Close the access panel Replacing the Printer Paper When the printer paper roll is empty the sterilizer displays a message Printer is out of paper Please load a new roll 1 Open the pr...

Страница 69: ...w paper roll as shown in the following figure The paper should feed from the top of the roll Figure 30 Insert a New Paper Roll 4 Pull a short length of paper over the top of the printer door 5 Align t...

Страница 70: ...r Door Latches Securely and the Paper is in Place 7 Press the paper advance button Check the alignment of the paper and make certain it does not jam or misfeed Figure 32 Press the Paper Advance Button...

Страница 71: ...ese guidelines 1 Turn off the power to the sterilizer before cleaning the exterior 2 Never allow cleaning solution or water to enter the interior or chamber Moisten a cloth with nonabrasive detergent...

Страница 72: ...lens must be kept clean Wipe off the lens once every three months or when an accumulation of debris is noted This is shown in the following figure Figure 33 Cleaning the Hydrogen Peroxide Monitor Lens...

Страница 73: ...menu and press the PCMCIA button Either method allows you to safely remove the PCMCIA card 2 Open the cassette access door 3 Eject the PCMCIA card by pressing the eject button on the top of the card s...

Страница 74: ...the PCMCIA Card Correctly Note The STERRAD 100NX Sterilizer will not operate unless the PCMCIA card is properly installed Data Transfer Using a Memory Stick A memory stick can be inserted in to the US...

Страница 75: ...on system or treatment and recycling facility Follow decontamination instructions before returning waste Contact your ASP Representative if you need assistance Other Countries Prior to disposal of the...

Страница 76: ...7Maintenance 74 STERRAD 100NX User s Guide D R A F T...

Страница 77: ...he memory holds data from the last 200 cycles After 200 cycles are completed the oldest cycle history record is overwritten with new data from the 201st cycle If your sterilizer is configured with the...

Страница 78: ...selected Cycle History file on the screen Print Cycle Short prints a short format report of the selected cycle history file Print Cycle Long prints a long format report of the selected cycle history...

Страница 79: ...the cycle status lists the date and duration of the cycle and shows operator and load identifying information The short format report is useful for record keeping purposes and providing traceability o...

Страница 80: ...8Reports and Files 78 STERRAD 100NX User s Guide D R A F T...

Страница 81: ...l is enabled through the System Configuration screen and user identifications passwords and access levels are assigned and maintained through the User Administration screens There are three levels of...

Страница 82: ...ileges touches an Additional Utilities button on any screen the Login screen will be displayed with the message Supervisor or Service Level Login Required The Additional Utilities Menu allows supervis...

Страница 83: ...pload file reads the load items database file from a USB memory stick Input Output door open opens the door on the input or output side Input Output door close closes the door on the input or output s...

Страница 84: ...you must touch the AM or PM buttons to indicate the correct time Time Zone Scroll through the selections until your time zone is displayed Date Format Select the desired format for the date The forma...

Страница 85: ...select your preferred settings Figure 41 System Configuration Access Control Option User Login requires that a user identification and password be entered before the sterilizer can be loaded and run T...

Страница 86: ...the Cycle Notes screen to be displayed after login This is the factory default setting Disabled skips the Cycle Notes screen Network Option Enabled allows the sterilizer to transmit data on a network...

Страница 87: ...the settings and return to the previous screen Figure 42 Sterilizer Settings Facility Name Enter the name of the hospital or medical facility Department Name Enter the name of the department you wish...

Страница 88: ...USB port Short Format instructs the sterilizer to print only the short report when a cycle is complete This is the factory default setting Long Format instructs the sterilizer to print only the long...

Страница 89: ...sfer via a network to a remote PC upon cycle completion Touch Done to save the settings Touch Cancel to return to the previous screen Figure 44 Transfer Settings Cancel Done To cancel system configura...

Страница 90: ...ur password a service call is necessary for you to regain access to the supervisor area of the system Figure 45 User Administration Add User displays the Add User screen On this screen you can set up...

Страница 91: ...erator and Password fields are case sensitive 2 Enter the user s password in the Password field The entry must be alpha numeric no more than 10 characters 3 Scroll through the Access Level selections...

Страница 92: ...user s identification password and access level Figure 47 Modify User 1 Touch the user s name whose information you wish to edit or delete 2 Touch Delete User to remove the user from the access list...

Страница 93: ...ly choose Operator or Supervisor Only Service Users can select Service level access 5 Touch the Cancel button to exit this screen and return to the Modify User screen 6 Touch the Done button when you...

Страница 94: ...cess levels Use Microsoft Notepad to create the entry Save the file as users rec and in the Encoding drop down menu in Notepad Save select UTF 8 Each entry should be separated by a comma only no space...

Страница 95: ...l resistant latex PVC vinyl or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette Hydrogen peroxide liquid may be present on the cassette the load or in...

Страница 96: ...ion moves the cassette from inside the sterilizer to the cassette box The remaining volume of hydrogen peroxide is displayed on the screen Touch Dispose Cassette to move the cassette into the cassette...

Страница 97: ...ilization If this peroxide expires you must dispose of the peroxide remaining in the system Peroxide Clearance must be performed when a message appears or no subsequent DUO cycles can be run Note Befo...

Страница 98: ...s selected the sterilizer runs ten operator assisted tests of the sterilizer subsystems You may skip one or more tests in the automatic sequence by touching the Cancel button when a test begins This c...

Страница 99: ...ASP Service Representatives Order Test Name What is tested Average Time to Run 1 Power Supply Test DC power supply 30 sec 2 Vacuum Test Vacuum pump pressure sensors and valves vacuum control vent inle...

Страница 100: ...rilizer calibration Scroll through the list and touch the file name you wish to view Touch the View button to display the selected calibration file Touch the Back button to return to the Additional Ut...

Страница 101: ...parated by a comma with no spaces before or after the comma Be sure to include a comma after the last load item Up to 1000 load items can be defined 2 Save the file with the file name loaditems txt an...

Страница 102: ...the side where you load your instruments for processing The Output Open Door and Output Close Door buttons open and close the output or clean side of the sterilizer This is the side on a two door uni...

Страница 103: ...you to the Additional Utilities Menu Enabled displays any cycle in your sterilizer which can be selected enabled The choices appear on the Start Cycle display Disabled removes the selected cycle butto...

Страница 104: ...9Access Levels and Supervisor Tasks 102 STERRAD 100NX User s Guide D R A F T...

Страница 105: ...circuit with separate neutral and ground conductors 200V 50 60 Hz Power Japan The sterilizer requires a four wire Delta configuration to a dedicated 30 AMP circuit Dimensions H 70 5 in 179 1 cm W 30...

Страница 106: ...minutes FLEX Cycle 42 minutes Connectors Network RJ45 Barcode reader USB Printer USB Main Power Cable 12 AWG 4 mm2 3 m 9 84 feet long 5 conductors NEMA L21 30P USA and Canada Each country is responsib...

Страница 107: ...al Electrical Equipment Part 1 General Requirements For Safety Japan Requirement EN 60601 1 2 Medical Electrical Equipment electromagnetic Compatibility Requirements and Tests ANSI AAMI ISO 14937 Ster...

Страница 108: ...A Specifications 106 STERRAD 100NX User s Guide D R A F T...

Страница 109: ...ntains the test vials pouch mats and BI STERRAD CYCLESURE 24 Biological Indicator 14324 Used as a standard method for frequent monitoring of the STERRAD Sterilizer cycles STERRAD SEALSURE Chemical Ind...

Страница 110: ...on in the cycle history file Independent Monitoring System IMS 10140 For compliance with ISO 14937 The Independent Monitoring System IMS is an optional feature that may be purchased and installed on t...

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