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STERRAD

200 Sterilization System

User’s Guide

REF 99712

99712_01
May 2008

Summary of Contents for ASP STERRAD 200

Page 1: ...STERRAD 200 Sterilization System User s Guide REF 99712 99712_01 May 2008...

Page 2: ...f this guide please visit www e ifu com 2008 Advanced Sterilization Products All rights reserved STERRAD is a registered trademark of Advanced Sterilization Products Teflon Tyvek and Nylon are registe...

Page 3: ...t Can be Sterilized in the STERRAD 200 System 19 Items Not Recommended 20 Cleaning Rinsing and Drying 21 Guidelines for Wrapping Packaging and Loading 23 Chapter 4 Day to Day Operation 27 Safe Operati...

Page 4: ...m Configuration Screen 67 User Password Administration Screen 68 Resetting the Date and Time 69 Network Settings Screen 71 Chapter 5 Routine Maintenance 73 Overview 73 Maintaining the Printer 74 Repla...

Page 5: ...on on using the sterilizer load preparation routine maintenance and troubleshooting the system should problems arise The appendix contains the system specification The chapters and the appendix are Ab...

Page 6: ...o use the sterilizer It shows you the typical displays that you will see as you use the sterilizer and the different screens available to the operator and administrator level passwords It details how...

Page 7: ...economical easy to use reliable and flexible sterilization method The length of all cycle phases and the setpoints for all critical process parameters are controlled by a microprocessor and software T...

Page 8: ...ystem Details Here are details of the important parts of the STERRAD 200 Sterilizer The items to be sterilized are placed on the two tier shelf The two tier shelf see the following diagram has 1 adjus...

Page 9: ...ge load into or out of the sterilizer Your system may have one or two doors If you have a two door unit a door is located on each side of the unit One side the input side is used for moving wrapped it...

Page 10: ...on the upper left front panel of the unit delivers printed messages process parameters and other information for your permanent records There is usually only one printer on the unit regardless of the...

Page 11: ...osive to skin eyes nose throat lungs and the gastrointestinal tract Always wear chemical resistant latex PVC vinyl or nitrile gloves when removing items from the sterilizer following a cancelled cycle...

Page 12: ...rogen peroxide mist can cause severe irritation of lungs throat and nose If inhalation occurs move the person to fresh air If the person is not breathing call for emergency medical attention or an amb...

Page 13: ...WITH THE GUIDELINES SPECIFIED IN THIS GUIDE In addition you should read the medical device manufacturer s instructions or call the ASP Customer Care Center to determine whether an item can be sterili...

Page 14: ...eyes can cause irreversible tissue damage If eye contact occurs immediately flush with large amounts of water and immediately consult a physician Inhalation of mist can cause severe irritation of lung...

Page 15: ...result in costly damage or unit malfunction and void the warranty Do not clean the chamber door area with abrasives The sterilization chamber uses an O ring vacuum seal to maintain a vacuum in the cha...

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Page 17: ...zation of both metal and nonmetal medical devices at low temperatures Because the cycle operates within a dry environment and at low temperatures it is especially suitable for instruments sensitive to...

Page 18: ...e STERRAD cycle consisting of a 6 minute 45 second injection phase followed by a 2 minute diffusion phase and a 2 minute plasma phase The validation studies were performed using a validation load cons...

Page 19: ...into the STERRAD 200 Sterilizer Important Stainless steel polyethylene and Teflon are the only types of lumens that can be sterilized in the STERRAD 200 Sterilizer Note There are a wide variety of ma...

Page 20: ...r Teflon Polyurethane Polyvinyl chloride PVC Silicone elastomers Stainless steel Teflon polytetrafluoroethylene Titanium No Don t Know No No Don t Know Yes 2 3 4 If the lumens do not conform to these...

Page 21: ...couplers Resectoscope working elements and sheaths Typical Devices Sterilized in the STERRAD 200 Sterilizer If you have questions about whether your particular device can be sterilized in the STERRAD...

Page 22: ...uze sponges or any item containing wood pulp Paper instrument count sheets or lot stickers Liquids and powders Items with mated Nylon surfaces Single use items for which the manufacturer does not reco...

Page 23: ...g Note Periodic careful inspection of the items after repeated exposure to disinfectant cleaner sterilant is necessary due to the potential damaging effects of the chemical agents on the items Cleanin...

Page 24: ...E TO ENSURE THAT INSTRUMENTS ARE COMPLETELY DRY BEFORE THEY ARE PROCESSED IN THE STERRAD STERILIZER MAY RESULT IN RESIDUAL HYDROGEN PEROXIDE BEING PRESENT ON THE OUTER SURFACE OF THE LOAD THIS MAY CAU...

Page 25: ...polypropylene sterilization wrap Do NOT use linen cellulosic or any materials shown in the Items Not Recommended list Follow the instructions for use included with the STERRAD Instrument Tray Mats to...

Page 26: ...ot allow any item to touch the walls of the sterilization chamber doors or electrode Note Do not stack instruments inside the trays Do not stack trays Do not stack trays within trays Do not wrap instr...

Page 27: ...STERRAD CycleSure Biological Indicator BI or an ASP approved biological indicator in the chamber Frequency of biological testing should be at least once per day or in accordance with your facility s...

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Page 29: ...matically monitors and controls the sterilization process The STERRAD 200 Sterilizer reports its status in three ways Touch Screen flat panel high color VGA Display The display indicates the status of...

Page 30: ...display may be slightly different Touch Back to return to the Load Item Data display Paper printout A printed record is produced after each cycle completion or cancellation This is a record of the cyc...

Page 31: ...ersion of the displays that appear and the steps required during the start up processing and the completion of a cycle Log in on the input side if login is enabled Load items into the sterilizer Enter...

Page 32: ...moved Button Function Touch to begin the sterilization cycle Touch to cancel a cycle or any other operation Touch to open the sterilizer door This button is only available when the cycle is not runnin...

Page 33: ...t up Touch to change the date and or time This button appears on the Function Button Bar on systems configured to operate without ID and password login Touch to display the utilities menu This menu in...

Page 34: ...ay be used in two ways it can be used with the carriage to transfer the load into and remove it from the sterilizer It may also remain in the sterilizer and the items to be sterilized can be placed on...

Page 35: ...ontainers cleared by the FDA for use in the STERRAD System follow the same procedures that are recommended for use with the STERRAD or APTIMAX Instrument Trays Do not stack instruments inside the cont...

Page 36: ...l Indicators contain microorganisms that are known to be resistant to the sterilization process and are one way to verify proper processing The biological indicator should be placed on the two tier sh...

Page 37: ...Day to Day Operation 4 STERRAD 200 User s Guide 35 STERRAD CycleSure Biological Indicator...

Page 38: ...peroxide The color of the Chemical Indicator Strips and Tape changes from red to gold or lighter when exposed to hydrogen peroxide Note Use only ASP biological indicators STERRAD SealSure Chemical Ind...

Page 39: ...with the carriage Make sure the two tier shelf is fully seated on the carriage and locked to the carriage before placing items on the two tier shelf The alignment wheels on the bottom of the two tier...

Page 40: ...If it does not require a load list you may skip this section and go directly to the section on transferring the load into the sterilizer 1 Enter the ID and password information as shown later in this...

Page 41: ...external keyboard the same way as shown above to enter the information Note The external keyboard must be attached and the system booted in order to function 2 Touch Done to complete the entry of the...

Page 42: ...y filled two tier shelf to the sterilizer Note Metal objects must not come into contact with the chamber walls the doors or the electrode Contact with the walls doors or electrode could damage the ste...

Page 43: ...lf forward into the sterilizer Make sure the alignment wheels are correctly positioned on the rails for smooth movement Continue pushing until the two tier shelf is completely inside the chamber and i...

Page 44: ...EYES NOSE THROAT LUNGS AND GASTROINTESTINAL TRACT DIRECT CONTACT WITH THE SKIN CAN CAUSE SEVERE IRRITATION IF SKIN CONTACT OCCURS IMMEDIATELY FLUSH WITH LARGE AMOUNTS OF WATER IF SYMPTOMS ARE SEVERE O...

Page 45: ...er display indicates that a new cassette is needed 2 Confirm that the chemical indicator strip on the cassette sleeve is NOT red red indicates a damaged cassette and concentrated hydrogen peroxide may...

Page 46: ...hows the printer on the input side Your system may be different 8 If the cardboard sleeve is not pushed in all the way the monitor continues to read INSERT CASSETTE 9 If the cardboard sleeve is proper...

Page 47: ...ith the STERRAD 200 Cassette for more information Starting a Cycle Note You must read understand and follow Chapter 2 For Your Safety prior to starting a cycle This display appears following log out o...

Page 48: ...ist You can log in to the system in 3 ways touch Keyboard to expand or collapse the virtual keyboard Type your ID and password using the virtual keyboard and touching the keys Type your ID and passwor...

Page 49: ...peration 4 STERRAD 200 User s Guide 47 Figure 15 Enter ID and password You would enter the load item list if that function is available at this point Load item list information is shown previously in...

Page 50: ...lation Password Level Function Access Capabilities Level 4 Service All the functions of password levels 1 3 Assign and change passwords of all levels Access to service menus Level 3 Administrator Assi...

Page 51: ...cycle after the following has taken place the load has been correctly placed on the two tier shelf and transferred to the sterilizer the biological and chemical indicators are in place and the load li...

Page 52: ...about the current cycle To display Cycle Notes first display the Function Button Bar then touch Cycle Notes Figure 17 Enter additional cycle information Use the virtual keyboard to enter cycle notes i...

Page 53: ...us of the unit at all times the current stage of the sterilization cycle the temperature in the chamber the pressure in the chamber the cycle start time and the cycle estimated end time You can change...

Page 54: ...4 Day to Day Operation 52 STERRAD 200 User s Guide Figure 19 Cycle In Progress Numerical Display...

Page 55: ...Successfully is shown on the display You are automatically logged out from the input side and must log in to the output side to open the door and remove the load After the load is removed touch Done a...

Page 56: ...Completed Successfully is shown on the display and only the output side is active You must touch Open Door FROM THE OUTPUT SIDE Remove the load and touch Done and Close Door to activate the input side...

Page 57: ...been removed from the output side and no further review of the information is necessary you should log out from the system This returns control to the input side To log out from the output side do th...

Page 58: ...rmation is displayed 3 Touch YES to confirm cancellation and cancel the cycle Touch NO to return to the Cycle in Progress display 4 Ten beeps sound and the Cycle Canceled Operator Cancellation message...

Page 59: ...restarting the new cycle WARNING IF A CYCLE CANCELS AND THE ITEMS IN THE LOAD APPEAR WET HYDROGEN PEROXIDE MAY BE PRESENT WEAR CHEMICAL RESISTANT LATEX PVC VINYL OR NITRILE GLOVES WHILE REMOVING THE...

Page 60: ...OINTESTINAL TRACT IF A CYCLE CANCELS AND THE ITEMS IN THE LOAD HAVE ANY VISIBLE MOISTURE OR LIQUID HYDROGEN PEROXIDE MAY BE PRESENT YOU MUST FOLLOW ALL SAFETY PRECAUTIONS REQUIRED FOR DEALING WITH HYD...

Page 61: ...r shelf in the sterilizer 5 Gently pull the two tier shelf onto the carriage Make sure the alignment wheels are correctly positioned on the rails for smooth movement Figure 24 Make sure the carriage i...

Page 62: ...uide Transferring the Load Without Using the Carriage 1 Touch Open Door 2 Move a trolley or supply cart to the sterilizer 3 Transfer the sterilized items to the trolley cart 4 Move the transferred ite...

Page 63: ...Day to Day Operation 4 STERRAD 200 User s Guide 61 Cycle Completion Flow Chart...

Page 64: ...Touch H2O2 Control The following is displayed Figure 25 H2O2 Interface Utility or Cassette Control Touch H2O2 Control on the Function Button Bar to view this display Touch Eject to eject a cassette th...

Page 65: ...the previous 1500 cycles The display shows the name of the cycle assigned by the system the size of the data file not available on all configurations and the cycle date and time Touch the file name an...

Page 66: ...4 Day to Day Operation 64 STERRAD 200 User s Guide Figure 27 Touch View History to see this display Figure 28 Touch Statistics to see this display...

Page 67: ...Touch Cycle History to see this display Touch Print to print the displayed information Figure 30 Touch Cycle Graph from the previous display to see this display The arrows advance through the graph T...

Page 68: ...tions of their functions are shown in this section System Setup Touch System Setup on the Utilities Menu to display the Configuration Menu The Configuration Menu allows you to select any of four confi...

Page 69: ...rdinarily not changed in the field Figure 32 System Configuration The Sterilizer Identification block allows you to enter the name of your facility and a label that identifies the individual machine T...

Page 70: ...gure 33 User Password Administration Adding a New User 1 Touch Add User to add a new user to the system 2 In the Username field type the new user s name 3 In the Password field type the new user s pas...

Page 71: ...assign a Service access level this is reserved for ASP Service personnel only 5 To cancel a change touch Cancel To accept the modified information touch Done To return to the Configuration Menu touch...

Page 72: ...the entered information Touch GO TO to exit the display 6 Touch Cancel the red circle at any time to cancel and exit without saving To change the time 1 Touch the Time format you desire The radio butt...

Page 73: ...with administrator level passwords access to configure the host name and port number when the sterilizer is connected to a network Figure 35 Network Settings 1 Use the virtual keyboard to enter the ho...

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Page 75: ...performing any other maintenance procedures WARNING ONLY EXPERIENCED TECHNICIANS WHO ARE FULLY TRAINED TO MAINTAIN THE STERRAD 200 STERILIZER SHOULD REPAIR OR ADJUST THIS UNIT USE OF UNAUTHORIZED PART...

Page 76: ...printer access service door on the upper left 2 Remove the used cartridge by firmly but carefully pulling on the right side as indicated by the arrow on the cartridge 3 Discard the used cartridge 4 In...

Page 77: ...tain the metal paper roller and insert it into the new roll of paper Figure 37 Retain the metal roller and insert it into the new paper core 3 Place a new paper roll into position so that the paper fe...

Page 78: ...ide surfaces of the sterilizer can be cleaned with water and a mild detergent The inside of the sterilization chamber does not normally require cleaning The chamber door and the chamber should not be...

Page 79: ...on it causes the computer in the sterilizer to reload the software control program automatically this action reboots the sterilizer Rebooting is used in certain troubleshooting procedures The display...

Page 80: ...unable to successfully complete the injection Call the ASP Customer Care Center H2O2 Delivery Failure H2O2 Delivery Failure System parameters are included on printout Acceptable hydrogen peroxide conc...

Page 81: ...ut Failure A timeout event occurred when the sterilizer was unable to complete a task within a preset timeout period Run the cycle again if the timeout problem persists call the ASP Customer Care Cent...

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Page 83: ...08 VAC 60 Hz 3 phase WYE 20 amps NEMA L21 20 receptacle CBA phase rotation Ambient Temperature 18o C to 40o C 64o F to 103o F Relative Humidity 10 to 85 up to 30o C ambient and linearly decreasing fro...

Page 84: ...s Equipment Rating High Voltage 200V 3 50 60 Hz 4 wire 15 A 208V 3 50 60 Hz 5 wire 15 A 380V 400V 415V 3 50 60 Hz 5 wire 15 A Electrical Requirements The STERRAD 200 Sterilizer should only be plugged...

Page 85: ...lists descriptions and calibration instructions on request to appropriately qualified personnel on the assemblies that ASP feels are serviceable by non ASP personnel Explanation of Warning Symbols IEC...

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