Steris P920011-649 Operator'S Manual Download Page 1

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OPERATOR MANUAL

Reliance

™

EPS Endoscope Processing System

(2022-03-10) P920011-649

Summary of Contents for P920011-649

Page 1: ...OPERATOR MANUAL Reliance EPS Endoscope Processing System 2022 03 10 P920011 649 ...

Page 2: ......

Page 3: ... and store in an accessible location Advisory IMPORTANT This processor is specifically designed to only process endoscopes as outlined in this manual and in the Endoscope Quick Reference Guide If there is any doubt about a specific endoscope material or product contact STERIS A listing of the Safety Precautions to be observed when operating and servicing this processor can be found in SECTION 1 of...

Page 4: ...te materials associated with the processor When disposing of waste materials ensure disposal is in compliance with federal state and local regulations Printer paper Recyclable Printer ribbon Not recyclable HEPA Filter Place HEPA filter in a large sealable bag Discard the bagged HEPA filter in an outdoor waste container Two Filter Cartridges from Dual Pre Filter and Pressure Regulator Assembly Disc...

Page 5: ...fection portion of the cycle is a non optional ten minute pre programmed phase The processor will automatically dilute the Reliance dry chemistry flow the high level disinfection solution through the endoscope lumens and spray it over their external surfaces without user exposure to the disinfection solution The STERIS chemical indicator validated for use with the Reliance EPS is used as an indepe...

Page 6: ...cle prior to fluid circulation within the processor The automated leak test is intended to detect leaks in flexible endoscopes prior to the start of the processing cycle The automated leak test IS NOT a substitute for the manufacturer s manual leak test IMPORTANT Operator must ensure all items have been prepared for immersion manually leak tested as per the instructions of the endoscope manufactur...

Page 7: ...ke note of the following registered trademarks that apply to the wording used throughout the manual Fujifilm is a registered trademark of FUJIFILM Olympus is a registered trademark of Olympus Optical Co Ltd Pentax is a registered trademark of Pentax Imaging Company Certification The Reliance EPS Processor meets the applicable requirements of the following standards Underwriters Laboratories UL Sta...

Page 8: ...ERIS Ireland Limited IDA Business and Technology Park Tullamore County Offaly R35 X865 Ireland Sales and Service Europe Middle East and Africa STERIS 116 Avenue de Magudas 33185 Le Haillan FRANCE Support Service by email Support_EMEA_IPT_SE steris com All other requests by phone 33 5 56 93 94 94 Website www steris com Sales and Service Americas Oceania except Australia and New Zealand and Asia STE...

Page 9: ...Anchorage System Accessory 2 2 2 2 Installation Verification 2 2 2 3 Chemical Additive Descriptions 2 4 2 3 1 Washing Detergent 2 4 2 3 2 Dry Chemistry 2 4 2 3 3 Decontamination Chemistry 2 4 3 COMPONENT IDENTIFICATION 3 1 3 1 Processor General 3 1 3 1 1 Chamber Door 3 1 3 1 2 Service Access Panel 3 1 3 1 3 Base 3 1 3 1 4 Bag in a Box Compartment 3 1 3 1 5 Chamber 3 3 3 1 6 0 2 µm Bacterial Retent...

Page 10: ... Endoscope Overview and Vocabulary 3 13 3 8 1 Endoscope Vocabulary List 3 13 3 8 2 Endoscope With Biopsy Suction System 3 14 3 8 3 Endoscope With Air Water System 3 15 4 PROCESSING INSTRUCTIONS 4 1 4 1 Principles of Operation Overview 4 1 4 1 1 Reliance EPS Endoscope Processing System 4 1 4 1 2 Optional Automated Leak Test Assembly 4 2 4 2 General Processing Guidelines 4 3 4 3 Loading Endoscope Pr...

Page 11: ...ation and Unloading Procedure 4 39 4 9 1 VERIFICATION 1 Parametric Controls 4 40 4 9 2 VERIFICATION 2 Process 4 41 4 9 3 VERIFICATION 3 Physical 4 41 4 10 Water Sampling Test 4 42 4 11 Post Processing Checklist 4 44 4 12 Pause or Abort Cycle 4 44 4 13 Responding to a Fault 4 47 4 13 1 Faults 4 47 4 13 2 Maintenance Due Faults 4 49 4 14 Shutdown 4 50 4 15 Power Failure 4 50 4 15 1 General 4 49 4 15...

Page 12: ...ining Holes and Punching Rods 6 7 6 8 Replacing Bag in a Box Container 6 8 6 9 Changing Printer Ribbon and Paper Roll 6 12 6 10 Changing Pre Filters 6 13 6 10 1 Dual Pre Filter and Pressure Regulator Assembly Cartridges Required Accessory 6 13 6 10 2 0 2 µm Bacterial Retentive Filter Cartridge 6 15 6 11 D LONG Cycle 6 17 6 12 Rotary Spray Arm Assembly 6 19 6 13 Lubrication of Leak Test Hose Assemb...

Page 13: ...xi 920011 649 Operator Manual Table of Contents ...

Page 14: ...s 4 8 Figure 4 6 Insert Insertion Tube Into Control Handle Boot Opening 4 9 Figure 4 7 Place Control Handle in Control Handle Boot 4 9 Figure 4 8 Split Insertion Tube Sleeve 4 9 Figure 4 9 Feeding Distal Tip Into Sleeve 4 10 Figure 4 10 Closing Sleeve Around Insertion Tube 4 10 Figure 4 11 Coil Light Guide Cable and Connect Flow Units 4 11 Figure 4 12 Plug to Process Only One Endoscope 4 12 Figure...

Page 15: ...1 D SHORT Sample Printout 6 6 Figure 6 2 Reliance CDS Draining Holes and Punching Rods 6 7 Figure 6 3 Bag in a Box Compartment 6 10 Figure 6 4 Changing Bag in a Box Container 6 11 Figure 6 5 Printer 6 12 Figure 6 6 Changing Dual Pre Filter and Pressure Regulator Assembly Cartridges Required Accessory 6 14 Figure 6 7 Replacing 0 2 µm Bacterial Retentive Filter Cartridge 6 16 Figure 6 8 Rotary Spray...

Page 16: ...nition of Symbols 1 6 5 CYCLE AND CONTROL VALUE PROGRAMMING Table 5 1 Reliance EPS Endoscope Processing System Cycle Description Chart 5 2 6 ROUTINE MAINTENANCE Table 6 1 Routine Maintenance Guide 6 2 8 RECOMMENDED SPARE PARTS AND CONSUMABLE PRODUCTS Table 8 1 Replacement Parts 8 1 LIST OF TABLES Table Description Page ...

Page 17: ...xiv 920011 649 Operator Manual List of Tables Healthcare Capital Equipment ...

Page 18: ...enance is required for safe and reliable operation of this equipment Contact STERIS to schedule preventive maintenance or obtain the necessary Maintenance Manual if preventive maintenance is done by the Customer Repairs and adjustments to this equipment must be made only by STERIS or STERIS trained service personnel Nonroutine maintenance performed by unqualified personnel or installation of unaut...

Page 19: ...ainers CIP 200 Acid Based Process and Research Cleaner is corrosive and can cause adverse effects to exposed tissues Do not get in eyes on skin or swallow Read and follow all precautions and instructions on cleaner label and in Safety Data Sheet SDS prior to handling CIP 200 Acid Based Process and Research Cleaner Bag in a Box container or servicing cleaner injection pump Wear appropriate Personal...

Page 20: ...accessories are not adequately processed rinsed and air purged when processing cycle is aborted REPROCESS LOAD Failure to process endoscopes and accessories within 30 minutes after manual cleaning may result in ineffective processing Follow all applicable instructions provided by the endoscope manufacturer for preparing endoscope and accessories for immersion Failure to do so may result in damage ...

Page 21: ... connectors on their cables or damage may result Inspect leak test hose assemblies and chamber flexible connections for presence of water prior to processing Water in tubing during automated leak test may cause damage to endoscope Remove all endoscopes accessories and Flow Units from control handle boots accessory pegs valve irrigators large mesh basket or accessory basket before performing a D SH...

Page 22: ...rtridge Do not touch cartridge with bare hands to prevent oils from being deposited When installing or replacing 0 2 µm bacterial retentive filter cartridge do not touch cartridge with bare hands to prevent oils from being deposited Open plastic wrapping and hold filter cartridge through wrapping when inserting into filter housing When using insertion tube sleeve ensure that sleeve handle is pushe...

Page 23: ...n of Symbols Symbol Definition Protective Earth Ground Warning Risk of Electric Shock Attention Refer to Manual For Further Instructions Fuse Identification Lubricate Cleaner Squeeze Tubes With Silicone Lubricant Laser Radiation Bar Code Reader Accessory ON For a Part of Equipment OFF For a Part of Equipment Reset Transfer of Heat Hot Surface Lockout Tagout ...

Page 24: ...ymbols Symbol Definition Model of Washer Disinfector Serial Number of Washer Disinfector Unique Device Identification Year of Manufacture of Washer Disinfector Safe Disposal of the Device Refer for Instruction for Use Medical Device Power Rating of Washer Disinfector Voltage Frequency Hertz Type of Supply Address of manufacturing facility Address of European Community Representative ...

Page 25: ...1 8 920011 649 Operator Manual Safety Precautions Healthcare Capital Equipment ...

Page 26: ...ctive pollution occurs but where occasional temporary conductivity caused by condensation can be expected as determined according to International Standard EN IEC 61010 1 Third Edition Refer to Reliance dry chemistry package insert for storage conditions Refer to STERIS chemical indicator for Reliance EPS package insert for storage conditions 2 1 2 Noise Level Equivalent Sound Pressure Level at wo...

Page 27: ...al health and safety regulations as well as electric and plumbing codes Disconnect switches not provided by STERIS capable of being locked in OFF position for maintenance purposes are installed in electrical supply lines near the processor Disconnect switches must be compliant with local occupational health and safety regulations as well as electric codes NOTE If processor is installed next to oth...

Page 28: ...h as STERIS part number A1002 upstream of Dual Pre Filter and Pressure Regulator Assembly required accessory Connect drain line to building waste line as specified on equipment drawing Electrical supply for processor is as specified on equipment drawing Air supply for processor is as specified on equipment drawing Floor underneath processor has a nonslip and noncombustible surface or is covered wi...

Page 29: ...ces such as GI flexible endoscopes bronchoscopes and their accessories without damaging the components or creating hazardous substances High level disinfection is achieved within the 50 57 C HLD phase of the endoscope processing cycle 4 minute generation segment followed by a 6 minute exposure segment 2 3 3 Decontamination Chemistry To help prevent contamination of the processor that may occur dur...

Page 30: ...ool to the touch A microswitch prevents a cycle from starting if the door is not fully closed The processor is also provided with an UNLOCK toggle switch that must be pressed before opening the door 3 1 2 Service Access Panel See Figure 3 1 The front bottom service access panel provides an easy access to the 0 2 µm bacterial retentive filter cleaner injection pumps fresh container detection meter ...

Page 31: ...ntertop Option Control Panel Window Chamber Door Service Access Panel Bag in a Box Compartment Base Figure 3 1 Processor With Countertop Option Side Enclosure Panel s Figure 3 2 Processor Without Countertop Option Identification Nameplate Base BACK OF PROCESSOR ...

Page 32: ...andle and is easily removed for cleaning An interior fluorescent light allows the operator to view inside the chamber during a Reliance EPS Endoscope Processing Cycle 3 1 6 0 2 µm Bacterial Retentive Filter See Figure 3 3 All the water supplied to the processor is filtered through a 0 2 µm bacterial retentive filter which is conveniently positioned behind the front service access panel below the c...

Page 33: ... Boot B Pressure Sensor Connector For Control Handle Boot A REF MB30_PP_51_2 Interior Fluorescent Light 0 2 µm Bacterial Retentive Filter Klenzyme Cleaner Injection Pump CIP 200 Cleaner Injection Pump Fresh Container Detection Meter Removable Debris Screen Sump Main Manifold Connector to Endoscope Processing Support Hot Water Inlet to Reliance CDS ...

Page 34: ...he support can hold up to two light guide cables and large compatible accessories When required Flow Units can be connected to the two fluid flow ports in the large mesh basket Bite blocks can be placed on the two accessory pegs In front of the large mesh basket three template slots are provided for measuring the diameter of insertion tubes The small accessory basket and cover is stored under the ...

Page 35: ...ix Large Mesh Basket Valve Irrigators and Caps Bumper Fluid Flow Ports Control Handle Boot Plug x Two Figure 3 4 Endoscope Processing Support Accessory Pegs Insertion Tube Diameter Template Slots x Three See Detail A Wheel Insertion Tube Slide Insertion Tube Diameter Template Slots Accessory Basket Reliance CDS Chemical Delivery System Rotary Spray Arm Assembly Detail A ...

Page 36: ...p interrupt cycle in progress ALARM REPLY touch pad press to stop intermittent alarm buzzer and acknowledge the displayed FAULT messages SINGLE endoscope processing cycle touch pad press to select the preprogrammed SINGLE cycle to process ONE endoscope Press once to use WASHING and High Level Disinfection HLD phases press a second time to process HLD phase only DOUBLE endoscope processing cycle to...

Page 37: ...trol Panel OPERATOR MODE SERVICE MODE Behind Control Panel Cover SUPERVISOR MODE Behind Control Panel Cover DOOR UNLOCK POWER ON OFF DISPLAY SCREEN SINGLE DOUBLE START STOP DECONTAM ALARM REPLY TEST CALIBRATION CONFIGURATION ESCAPE CHANGE VALUES PRINT ENTER SCROLL Arrows ...

Page 38: ... to generate a complete printout of the cycle in progress pressure and temperature values refer to SECTION 5 2 3 SETTING MISCELLANEOUS VALUES 3 3 3 Service Mode The Service mode section of the control panel is accessed behind the control panel cover Only a qualified service technician can access the Service mode menu to perform preventive maintenance testing and troubleshooting The Service mode to...

Page 39: ...inted from the Operator mode cycle parameters cycle in process parameters alarms and Service mode processor configuration values processor setup etc 3 4 Reliance Dry Chemistry The Reliance dry chemistry is a single use dry germicide for use only in the Reliance EPS Processor When used in conjunction with the Reliance EPS it provides high level disinfection of pre cleaned immersible reusable heat s...

Page 40: ...expiration date handling use instructions and Safety Precautions NOTE From this point forward in this manual the STERIS chemical indicator validated for use with the Reliance EPS will be referred to as chemical indicator 3 6 Bar Code Reader Accessory See Figure 3 7 The bar code reader is an optional accessory for the Reliance EPS Processor The bar code reader is used to input data associated with ...

Page 41: ... layer absolute membrane filter cartridge one pressure regulator to reduce incoming water pressure to 310 kPa 45 psig one spanner wrench to easily remove and reinstall filter bowls for maintenance refer to Figure 6 6 two manual ball shutoff valves pressure gauge Installation Instructions 920 500 287 REF 920 013 528 Pressure Regulator From Building Hot Water Supply Multi Layer Depth Media Filter Ca...

Page 42: ...alve air water valve port air water cylinder auxiliary water inlet channel auxiliary water supply inlet water jet inlet forward water jet water jet channel biopsy port forceps inlet channel inlet instrument channel port channel selector suction switch over lever instrument channel selector suction selector knob control handle control portion control section control body distal tip distal end eleva...

Page 43: ...ction biopsy channel may be accessed at three ports the suction barb which may be on the control handle or the light guide the suction valve port which is located on the control body and the biopsy port which is located on the control body The suction biopsy channel exits at the distal tip Figure 3 9 Example of an Endoscope With a Simple Biopsy Suction System Suction Valve Port Biopsy Port Suction...

Page 44: ...ately and continue down the insertion tube where they may connect again and exit at the distal tip Some flexible GI endoscopes have an air pipe which is also connected to the air water port Some gastroscopes or colonoscopes may have an auxiliary water channel The auxiliary water channel may be an independent channel that starts on the light guide connector or the control handle The auxiliary water...

Page 45: ...3 16 920011 649 Operator Manual Component Identification Healthcare Capital Equipment ...

Page 46: ...r Some endoscopes and accessories require special consideration Endoscopes with additional channels that do not have channel openings on the control handle must be processed with the aid of a STERIS Flow Unit Refer to the Endoscope Quick Reference Guide and the Quick Reference Wall Chart Flow Units for details Endoscopes with a non removable mechanically actuated valve on the control handle must b...

Page 47: ...arm is triggered Fault 52 or Fault 53 and the cycle is aborted No pressure is maintained in the connected endoscopes Refer to SECTION 4 4 4 STATUS for more details about the automated leak test status leak test passed or failed and to SECTION 7 TROUBLESHOOTING for more details on actions user is required to perform in case a failing leak test occurs Fault 52 or Fault 53 triggered 920 013 571 AUXIL...

Page 48: ...any endoscopes IMPORTANT The list of devices given in the Endoscope Quick Reference Guide may not be all inclusive but reflects the complete information available to STERIS Corporation at the date of its publication Medical devices can be added to the list without further notice To obtain the most current list of medical devices that can be processed in this processor contact STERIS Use the checkl...

Page 49: ...e and free of debris refer to Figure 3 3 6 Place accessories in Reliance EPS Processor refer to Endoscope Quick Reference Guide for more details a Place bite blocks on accessory pegs see Figure 4 2 b Open accessory basket cover c Place small items such as air water valves in accessory basket see Figure 4 2 Detail A STERIS CORP COPYRIGHT C 2011 READY MM DD YY HH MM XM WARNING INEFFECTIVE PROCESS HA...

Page 50: ... bougies follow instructions in Endoscope Quick Reference Guide for Flow Unit 5 Reliance CDS Chemical Delivery System Insert Bite Blocks on Accessory Pegs Valve Irrigator Cap Insert Suction Valves in Valve Irrigators Slide Accessory Basket Under Endoscope Processing Support Detail A Figure 4 2 Large Mesh Basket and Accessory Basket Insertion Tube Diameter Template Slots x Three Wire Mesh Cover Wir...

Page 51: ...evel disinfection solution 7 Valve irrigators are located in front of large mesh basket Suction valves must be processed in valve irrigators refer to Endoscope Quick Reference Guide for list of compatible suction valves and other accessories 8 Remove cap from valve irrigator by pressing down and turning counterclockwise Insert suction valve of endoscope that will be placed in control handle boot A...

Page 52: ...is larger slot use insertion tube sleeve NOT labeled with a color dot split insertion tube sleeve NOTE Some endoscopes have a distal tip that is larger than the insertion tube diameter These endoscopes will fit into a template slot but the distal tips will not fit into the designated insertion tube sleeve Use the split insertion tube sleeve NOT labeled with a color dot to process these endoscopes ...

Page 53: ... special placement instructions required for the endoscope being processed IMPORTANT Verify angulation knobs are unlocked and distal tip is straight before proceeding to next step WARNING INEFFECTIVE PROCESS HAZARD When placing an endoscope in control handle boot ensure endoscope suction barb is not trapped in the flaps of universal cord port Also ensure light guide cable is correctly placed betwe...

Page 54: ... follows see Figure 4 8 a Open split insertion tube sleeve as shown in Figure 4 8 CAUTION POSSIBLEEQUIPMENT DAMAGE Do not place light guide ultrasound connectors on their cables or damage may result Figure 4 6 Insert Insertion Tube Into Control Handle Boot Opening IMPORTANT Hold Insertion Tube Near Control Handle Boot Opening to Prevent Excessive Bending or Kinking Insertion Tube Control Handle Li...

Page 55: ...are unlocked and distal tip is straight before proceeding to next step e Carefully feed distal end of insertion tube into insertion tube slide see Figures 4 6 and 4 7 Feed nearly all insertion tube and when control handle is located over control handle boot leave control handle to rest on control handle boot frame IMPORTANT Hold insertion tube near control handle boot opening to ease insertion and...

Page 56: ...asound cables carefully in large mesh basket see Figure 4 11 Allow cables to coil naturally Be careful not to kink or overbend cable 15 Rest light guide ultrasound connectors in large mesh basket DO NOT place light guide ultrasound connectors on top of light guide ultrasound cables see Figure 4 11 16 If processing a second endoscope place it in control handle boot B repeating Steps 6 to 15 If only...

Page 57: ...efore closing control handle boot A ensure light guide cable from control handle boot B will not interfere with proper closure 20 Close both control handle boots and clasp three latches Clasp middle latch first Figure 4 12 Plug to Process Only One Endoscope CONTROL HANDLE BOOT B Control Handle Boot Plug Fluid Delivery Port Universal Cord Port Figure 4 13 Use Control Handle Boot Plug to Process End...

Page 58: ...ndoscopes and to run a DOUBLE endoscope processing cycle with washing phase proceed as follows a Verify display shows b Verify chamber door is open If not press UNLOCK toggle switch to unlock processor door and open door Printer prints DOOR OPEN HH MM SS XM c Pull endoscope processing support out of chamber d Open control handle boots A and B Insert one insertion tube sleeve with a blue dot identi...

Page 59: ...4 14 920011 649 Operator Manual Processing Instructions Flaps Insertion Tube Sleeve With a Blue Dot Identification Figure 4 14 Insertion Tube Sleeve Test Cord Universal Cord Port Figure 4 15 Test Cord ...

Page 60: ...ee Figures 4 16 4 17 and 4 18 IMPORTANT Ensure leak test is selected in Miscellaneous Values menu of Supervisor mode refer to SECTION 5 2 3 SETTING MISCELLANEOUS VALUES for details 4 4 1 Preparation Ensure endoscopes and their accessories were prepared and loaded as described in Endoscope Quick Reference Guide and in SECTION 4 3 LOADING ENDOSCOPE PROCESSING SUPPORT Insert the Reliance dry chemistr...

Page 61: ...ble connection into quick connect Quick connect locking sleeve moves forward and locks automatically see Figure 4 17 IMPORTANT Only endoscopes with a leak test port on the light guide cable can be leak tested 5 Connect other extremity of leak test hose s to endoscope leak test port s see Figure 4 18 6 Insert Reliance dry chemistry container and STERIS chemical indicator strip in endoscope processi...

Page 62: ...OCESSOR IS NOW READY TO PROCESS A CYCLE Figure 4 17 Connect Quick Connect Extremity of Leak Test Hose s to Flexible Connection s Flexible Connection Quick Connect Extremity Quick Connect Locking Sleeve Leak Test Hose Figure 4 18 Connect Other Extremity of Leak Test Hose s to Endoscope s Endoscope Leak Test Port Leak Test Hose ...

Page 63: ...connect see Figure 4 17 4 4 2 Pentax Leak Test Adapter for i10c Series If reprocessing Pentax i10c Series endoscopes follow the Pentax reprocessing instructions for leak test preparation see Wall Chart PTPW3028 Use of the Pentax Venting Connector Adapter OE C29 is required for leak testing these endoscopes 4 4 3 Starting Cycle The leak test sequence is initiated after the door is closed the SINGLE...

Page 64: ...e cycle is aborted A failed leak test indicates there is a leak in the endoscope If the automated leak test fails an alarm sounds and display shows or alternating with and printer message is HH MM SS XM MM DD YY FAULT 52 FAULT 52 CYCLE DELAYED FAULT 53 CYCLE DELAYED SEE FAULT CHART CYCLE DELAYED CAUTION POSSIBLEEQUIPMENT DAMAGE Remove any automated leak test hoses present in endoscope processing s...

Page 65: ...ssing Instructions or HH MM SS XM MM DD YY FAULT 53 NOTE If an error message is displayed at any time during cycle refer to SECTION 7 TROUBLESHOOTING for possible causes and solutions Alarm can be silenced by pressing ALARM REPLY touch pad ...

Page 66: ...ep 1 of SECTION 4 4 4 OPTIONAL AUTOMATED LEAK TEST AUDIBLE SIGNAL No Leak Test None Printout LeakTest Pass or Fail Printout Resume Connect Hose s Do Not Acknowledge Audible Signal No LeakTest None Printout Start New Cycle Possible cause Hose connected to endoscope but not connected to Reliance EPS Processor If automated leak test fails an alarm is triggered Figure 4 20 Leak Test Hoses Connections ...

Page 67: ...ot performed HH MM SSXM LEAK TEST 1 NONE LEAK TEST 2 NONE 2 If audible signal is acknowledged operator presses STOP touch pad to silence audible signal Processor drains and display shows Once draining is completed operator can then choose between resuming or cancelling cycle Display shows a If operator chooses to resume cycle without any hoses connected either to endoscope or processor filling pha...

Page 68: ...y proceed as follows 1 Select appropriate leak test hose see SECTION 4 4 1 PREPARATION and Figure 4 16 for details 2 Connect quick connect extremity of leak test hose s to flexible connection s labeled 1 and or 2 see SECTION 4 4 1 PREPARATION for details 3 Select appropriate hose plug For example hose plugs are identified O for Olympus endoscopes P for Pentax endoscopes or F for Fujifilm endoscope...

Page 69: ...is displayed to indicate self diagnostic is running The following printout is printed at the end of the leak test self diagnostic HH MM SS XM MM DD YY LEAK TEST SELF DIAGNOSTIC TEST 1 XXXX TEST 2 XXXX XXXX shows PASS for passing tests or FAIL for failed tests Repeat Steps 1 to 5 to perform leak test self diagnostic with hose assembly using second hose assembly LEAK TEST SELF DIAGNOSTIC ...

Page 70: ...roduct for Reliance dry chemistry Inspect Reliance dry chemistry container for damage prior to use Do not use damaged containers if damage is observed follow directions for disposal in Reliance dry chemistry package insert Storage of Reliance dry chemistry container should be in a clean dry location Reliance dry chemistry container should not be exposed to extreme heat or humidity Refer to package...

Page 71: ...opening provided indicator pad down and facing towards operator WARNING INEFFECTIVE PROCESS HAZARD Before starting a cycle ensure to verify Reliance dry chemistry container s expiration date and STERIS chemical indicator bottle s expiration date are valid If expiration date is not valid use a new Reliance dry chemistry container or a new chemical indicator strip Failure to do so may result in inef...

Page 72: ...o one of three template slots located in front of endoscope processing support If required place proper insertion tube sleeve into control handle boot A and or B see SECTION 4 3 LOADING ENDOSCOPE PROCESSING SUPPORT Endoscope 1 is placed in control handle boot A see SECTION 4 3 LOADING ENDOSCOPE PROCESSING SUPPORT If endoscope 1 does not have a light guide cable a control handle boot plug is placed...

Page 73: ...ess one endoscope one endoscope is placed in control handle boot A through washing and high level disinfection phases SINGLE endoscope processing cycle without washing phase to process one endoscope one endoscope is placed in control handle boot A through a high level disinfection phase only DOUBLE endoscope processing cycle with washing phase to process two endoscopes one endoscope is placed in c...

Page 74: ...pe leak test port s see SECTION 4 4 1 PREPARATION 3 Ensure quick connect extremity of leak test hose s is are connected to flexible connection s see SECTION 4 4 1 PREPARATION 4 Ensure pre processing checklist was completed see SECTION 4 7 PRE PROCESSING CHECKLIST IMPORTANT Ensure no accessories stick out of endoscope processing support 5 Roll endoscope processing support into chamber Push firmly s...

Page 75: ...hanism Ensure door is closed tightly Verify display shows current date and time then if optional Automated Leak Test Assembly is present NOTE If display shows D SHORT REQUIRED XX HOURS LEFT or D SHORT REQUIRED XX MINUTES LEFT refer to SECTION 6 5 D SHORT CYCLE If display shows D LONG REQUIRED NOW refer to SECTION 6 11 D LONG CYCLE IMPORTANT When a SINGLE or a DOUBLE cycle is selected and WASHING S...

Page 76: ...on is set to NO in Miscellaneous Values menu of Supervisor mode refer to SECTION 5 2 3 SETTING MISCELLANEOUS VALUES operator cannot select an endoscope processing cycle WITHOUT WASHING because this option has been disabled Only SINGLE endoscope processing cycle with washing phase and DOUBLE endoscope processing cycle with washing phase are available Pressing touch pad a second time will have no ef...

Page 77: ...mmed data is printed see Figures 4 24 and 4 25 NOTE If invalid bar code is scanned display shows OPERATOR ID IS INVALID alternating with OPERATOR ID STOP RETRY 7 Press START touch pad to confirm Operator ID or STOP touch pad to cancel and scan another bar code 8 Repeat for each of the following bar code IDs Scan Boot A Patient ID Scan Boot B Patient ID DOUBLE endoscope processing cycle only Scan B...

Page 78: ...ional Automated Leak Test Assembly the processor proceeds through the programmed phases of the SINGLE processing cycle If a SINGLE processing cycle is selected and two endoscopes are connected to the optional Automated Leak Test Assembly an alarm sounds This alarm indicates that the cycle should be aborted and that a DOUBLE processing cycle should be selected to process two endoscopes Display show...

Page 79: ...rt up of SINGLE and DOUBLE cycles with WASHING PHASE Level of chemical in CIP 200 Acid Based Process and Research Cleaner Bag in a Box is automatically verified during start up of D LONG cycle 1 If chemical level is low when START touch pad is pressed display shows or alternating with and IMPORTANT When previous messages are displayed approximately five cycles can be processed before indicated Bag...

Page 80: ...in control handle boot A in kPa or psig B Pressure in control handle boot B in kPa or psig NOTE If an error message is displayed or an abnormal situation occurs at any time during cycle refer to SECTION 7 TROUBLESHOOTING for possible causes and solutions SINGLE WASH WATER XXX X C AIR XXX X C A XXX X KPA B XXX X KPA or Cycle In Process Segment In Process WARNING PERSONAL INJURY AND OR EQUIPMENT DAM...

Page 81: ...M SS CHEMICAL KLENZYME CONCENT 2 mL L HH MM SS XM RINSE WATER TYPE HOT RECIRC TIME MM SS HH MM SS XM HLD WATER TYPE HOT TEMPERATURE XX X C GENERATION 04 00 DISINFECTION 06 00 HH MM SS XM RINSE 1 WATER TYPE HOT RECIRC TIME MM SS HH MM SS XM RINSE 2 WATER TYPE HOT RECIRC TIME MM SS HH MM SS XM AIR PURGE RECIRC TIME MM SS COMPLETED HH MM SS XM TOTAL CYCLE HH MM SS MAXIMUM FILLING TIME MM SS STOP PRES...

Page 82: ...EMPERATURE Temperature set point during heated phases CHEMICAL Name of chemical additive used for wash segment CONCENT Concentration of chemical additive injected for wash segment GENERATION Duration of high level disinfection solution generation DISINFECTION Duration of exposure to high level disinfection solution RECIRC TIME Duration of solution air recirculation COMPLETED Time at which cycle wa...

Page 83: ... shows 4 Printer records complete cycle printout see Figures 4 24 and 4 25 to view an example of a typical printout If EXTENDED PRINTOUT feature is enabled in Miscellaneous menu of Supervisor mode there is additional space on printout to allow operator to write down additional information refer to SECTION 5 2 3 SETTING MISCELLANEOUS VALUES for setting procedure and see Figures 4 24 and 4 25 to vie...

Page 84: ...Should any processing cycle fail verification endoscope s must be reprocessed in another cycle Parametric controls are performed by the Reliance EPS Processor to ensure each cycle meets specifications and cycle data is documented on the printed tape see Figures 4 24 and 4 25 Process verification is achieved through use of a STERIS chemical indicator and fresh dry chemistry container detection mete...

Page 85: ... also recorded on printout READY TO UNLOAD This printout means cycle is successfully completed IMPORTANT If cycle was interrupted by a fault or not completed successfully refer to SECTION 7 TROUBLESHOOTING endoscope s must be processed again through another cycle with a new dry chemistry container and chemical indicator 2 Press UNLOCK toggle switch to unlock and open processor door Printer records...

Page 86: ...s from processor as soon as possible after cycle is completed 2 If used verify Flow Units are still connected If Flow Units are disconnected refer to SECTION 7 TROUBLESHOOTING 3 Disconnect any Flow Unit used from endoscopes and fluid flow ports Store in a safe and clean location 4 If optional automated leak test was performed disconnect leak test hose s from endoscope leak test port s and from fle...

Page 87: ...S Endoscope Processing System P920501 501 IMPORTANT Water sampling should only be conducted by a trained microbiologist and under standard hospital procedures for infection hazardous waste and pathogen control Sterile harvesting is a technique sensitive method and close consideration should be given to aseptic technique To perform a Water Sampling test proceed as follows 1 Ensure water sampling op...

Page 88: ... test supervisor must set water sampling option to YES again in Miscellaneous Values menu of Supervisor mode When cycle is completed printer records a complete cycle printout see Figures 4 24 and 4 25 to view an example of a typical printout The following information is also recorded on printout WATER SAMPLE TEST DOOR OPEN HH MM SS XM DOOR CLOSE HH MM SS XM RESUME HH MM SS XM NOTE When cycle is co...

Page 89: ...cessing support If all above items are satisfactory the endoscope processing cycle is complete 4 12 Pause or Abort Cycle If the operator for any reason wants to perform a verification inside the chamber during a cycle the processor operation can be halted at any time by pressing the STOP touch pad Once interrupted cycle either can be resumed or not depending on the cycle phase in progress This is ...

Page 90: ... filled with filtered hot tap water water is recirculated water is drained NOTE Procedure takes 7 to 15 minutes depending on cycle phase in progress Door remains locked until end of Abort sequence s 4 If cycle cannot be resumed display shows Press STOP touch pad to abort cycle During Abort sequence display shows STOP PRESSED CYCLE DELAYED START TO RESUME STOP TO CANCEL STOP TO CANCEL CANCELLING CY...

Page 91: ...r records CYCLE CANCEL HH MM SS 5 Press ALARM REPLY touch pad to silence buzzer 6 Press UNLOCK toggle switch to unlock processor door Open door PLEASE WAIT MMM MIN WARNING CYCLE CANCELLED CHEM CONTAINER MUST BE REPLACED CHEM CONTAINER STILL USABLE LOAD NOT H L DISINFECTED CYCLE CANCELLED READY TO UNLOAD If Disinfection Solution Was Generated Within Processor If Disinfection Solution Was Not Genera...

Page 92: ...r records HH MM SS XM MM DD YY FAULT XX 2 Press ALARM REPLY touch pad to acknowledge alarm This will record time at which operator acknowledged alarm Printer records HH MM SSXM MM DD YY ALARM ACKNOWLEDGED If FAULT alarm requires no further action for example refer to SECTION 7 3 MAINTENANCE DUE ALARM CHART or if the operator has been able to solve the fault condition using SECTION 7 TROUBLESHOOTIN...

Page 93: ...nating with then then or then and printer records WARNING LOAD NOT H L DISINFECTED STOP TO CANCEL CANCELLING CYCLE PLEASE WAIT MMM MIN WARNING CYCLE CANCELLED CHEM CONTAINER MUST BE REPLACED CHEM CONTAINER STILL USABLE LOAD NOT H L DISINFECTED WARNING INEFFECTIVE PROCESS HAZARD Correct function of the system is only ensured after any diagnosed errors have been found corrected and a successful proc...

Page 94: ...the processor 1 When a MAINTENANCE DUE alarm occurs display shows alternating with and printer records HH MM SS XM MM DD YY MAINTENANCE XX 2 Press ALARM REPLY touch pad to acknowledge alarm Display shows NOTE For MAINTENANCE DUE alarms refer to SECTION 7 3 MAINTENANCE DUE ALARM CHART for a detailed listing of maintenance alarms If maintenance is not performed on processor MAINTENANCE DUE alarm wil...

Page 95: ...when power is restored display shows alternating with 2 Press ALARM REPLY touch pad to acknowledge alarm Display shows 3 Press STOP touch pad to abort Processor performs Abort sequence three times chamber is filled with filtered tap water and water is recirculated and then drained approximately 15 minutes total Display shows alternating with READY MM DD YY HH MM XM WARNING ELECTRIC SHOCK AND OR BU...

Page 96: ... sequence is completed display shows and printer records CYCLE CANCEL HH MM SS XX WARNING CYCLE CANCELLED CHEM CONTAINER MUST BE REPLACED CHEM CONTAINER STILL USABLE LOAD NOT H L DISINFECTED CYCLE CANCELLED READY TO UNLOAD If Disinfection Solution Was Generated Within Processor If Disinfection Solution Was Not Generated Within Processor ...

Page 97: ...amber door Exercise caution to avoid contact with the solution Avoid inhaling fumes from inside the chamber 8 Slowly and carefully pull out endoscope processing support 9 Carefully remove flexible endoscopes accessories valves and Flow Units 10 Slowly and carefully push endoscope processing support back into chamber IMPORTANT Ensure manual safety latch ring is not trapped before closing the chambe...

Page 98: ...ed or expired follow disposal instructions provided in the dry chemistry package insert IMPORTANT Follow all applicable local and national regulations Refer to Reliance dry chemistry insert for all applicable warnings and cautions Figure 4 26 Door Manual Safety Latch Control Panel Cover Bag in a Box Compartment Door Door Manual Safety Latch Base ...

Page 99: ...sufficient pressure inside control handle boots in absence of endoscopes To run a DOUBLE endoscope processing cycle without washing phase and without endoscopes proceed as follows 1 Verify display shows 2 If chamber door is not open press UNLOCK toggle switch to unlock processor door and open door Printer prints DOOR OPEN HH MM SS XM 3 Pull endoscope processing support out of chamber 4 Open contro...

Page 100: ...DS If not insert expired Reliance dry chemistry container refer to Reliance dry chemistry package insert 8 Close Reliance CDS and latch 9 Push endoscope processing support back into chamber 10 Close processor door 11 Press DOUBLE touch pad twice to process a DOUBLE endoscope processing cycle without washing see SECTION 4 8 PROCESSING CYCLE 12 Let cycle proceed through HLD phase refer to Table 5 1 ...

Page 101: ...h pad to silence audible alarm Display shows 14 Press STOP touch pad to abort cycle Processor performs Abort sequence three times chamber is filled with filtered tap water and water is recirculated and then drained approximately 15 minutes total 15 See SECTION 4 12 PAUSE OR ABORT CYCLE for more details on Abort sequence STOP TO CANCEL ...

Page 102: ...ed of a combination of some or all of the following phases WASHING Includes WASH and RINSE segments This phase can be omitted by operator if only high level disinfection of endoscope is required refer to SECTION 4 8 2 STARTING CYCLE and if supervisor allowed this selection see SECTION 5 2 3 SETTING MISCELLANEOUS VALUES Supervisor can set WASHING phase to be repeated twice for each SINGLE or DOUBLE...

Page 103: ... 1 4 2 1 4 Decontamination cycle only do not run with endoscopes D SHORT Phase WASH AIR PURGE Water type HTW Temperature set point C F Heated to 82 2 180 0 Heated to 115 6 240 0 Time 13 00 20 00 Venting 10 00 Cooling 10 00 Chemical additive Concentration mL L oz gal Decontamination cycle only do not run with endoscopes D LONG Phase WASH RINSE 1 RINSE 2 RINSE 3 AIR PURGE Water type HTW HTW HTW HTW ...

Page 104: ...ater sampling activate deactivate low chemical warning activate deactivate automatic D SHORT select automated leak test feature if optional Automated Leak Test Assembly is present set enzyme type activate deactivate printout features duplicate multiple and or extended printouts print values and cycles Prime Pump To prime selected cleaner injection pumps manually Bar Code Test if accessory is prese...

Page 105: ... Cycle Description Chart for available value ranges 1 Access Supervisor mode as explained in SECTION 5 2 1 ACCESSING SUPERVISOR MODE Display shows __ blinking 2 Press SCROLL arrows up or down to choose SINGLE or DOUBLE NOTE It is also possible to select cycle by pressing directly on corresponding cycle touch pad STERIS CORP COPYRIGHT C 2011 READY MM DD YY HH MM XM SCROLL TO MODIFY SINGLE DISPLAY F...

Page 106: ...PERATOR MANUAL for four seconds then control returns to current display 5 Press ENTER touch pad to confirm new WASH 1 segment time value Printer records CYCLE MODIFICATION SAVED NOTE For new values to be saved it is necessary to scroll through all phases of a cycle and confirm values by pressing ENTER touch pad after each phase even if no value was changed or To cancel a modification press ESC tou...

Page 107: ...s ENTER touch pad to confirm new AIR PURGE phase time value Printer records CYCLE MODIFICATION SAVED NOTE For new values to be saved it is necessary to scroll through all phases of a cycle and confirm values by pressing ENTER touch pad after each phase even if no value was changed or To cancel a modification press ESC touch pad once Display returns to cycle being modified Values are not saved Prin...

Page 108: ... TIME 05 00 CHEMICAL KLENZYME CONCENTR 2 mL L RINSE WATER TYPE HOT RECIRC TIME 00 40 HLD WATER TYPE HOT TEMPERATURE 50 0 C GENERATION 04 00 DISINFECTION 06 00 RINSE 1 WATER TYPE HOT RECIRC TIME 00 40 RINSE 2 WATER TYPE HOT RECIRC TIME 00 40 AIR PURGE RECIRC TIME 04 00 Display shows __ blinking 12 Press SCROLL arrows up or down to choose another Supervisor mode menu or Press ESC touch pad to exit S...

Page 109: ...ate or deactivate REPEAT WASHING feature for SINGLE or DOUBLE endoscope processing cycle Water Sampling To allow opening of chamber door just before draining sub phase of RINSE 2 phase At that time a sample of water can be taken from the sump Low Chemical Warning To warn operator when chemical level is getting low i e approximately five cycles to process before chemical is empty Automatic D SHORT ...

Page 110: ...me setting Display shows __ blinking NOTE Date format can be changed to MM DD YY DD MM YY or YY MM DD in Service mode by a qualified service technician For instructions refer to SECTION 2 SERVICE MODE PROCEDURE of Maintenance Manual P764333 736 8 Press SCROLL arrows left or right to set current date 9 Press ENTER touch pad to confirm setting Display shows __ blinking NOTE Concerning bar code reade...

Page 111: ...ith endoscope to be processed Patient ID is recorded on cycle printout Press SCROLL arrows up or down to enable YES or disable NO optional Patient ID function 15 Press ENTER touch pad to confirm setting Display shows __ blinking 16 Device ID function allows operator to scan a bar code to identify endoscope to be processed Device ID is recorded on cycle printout Press SCROLL arrows up or down to en...

Page 112: ...r is replaced After a few months of observing alarm pattern supervisor may decide to shorten delay as a preventive measure to be able to change filter before FAULT 30 0 2 µm FILTER FAILURE alarm is triggered or to prevent filling time from becoming too long see SECTION 7 TROUBLESHOOTING for details on fault causes and solutions To change setting press SCROLL arrows left or right to scroll to numbe...

Page 113: ...er to SECTION 4 10 WATER SAMPLING TEST and Table 5 1 Cycle Description Chart for more details Press SCROLL arrows up or down to enable YES or disable NO WATER SAMPLING option NOTE When cycle is completed water sampling option is automatically cleared by processor To perform another Water Sampling supervisor must set water sampling option to YES again 29 Press ENTER touch pad to confirm setting Dis...

Page 114: ... or NO no automated leak test NOTE Leak test is automatically set to YES through a jumper in the connection 34 Press ENTER touch pad to confirm selection Display shows __ blinking Press SCROLL arrows up or down to toggle between KLENZYME or PROLYSTICA 35 Press ENTER touch pad to confirm selection Display shows __ blinking 36 DUPLICATE PRINTOUT feature is set to YES to allow operator to generate a ...

Page 115: ...to generate for each device Up to two printouts can be generated per device 39 Press ENTER touch pad to confirm selection Display shows __ blinking 40 EXTEND PRINTOUT feature is set to YES so additional space is printed on cycle printout to allow operator to write down additional information Press SCROLL arrows up or down to enable YES or disable NO EXTEND PRINTOUT feature 41 Press ENTER touch pad...

Page 116: ... YES NO DUPLICATE PRINTOUT YES NO QTY CYCLE PRINTS X EXTENDED PRINTS YES LANGUAGE ENGLISH FRANÇAIS ESPANOL OPERATORS LIST 00001 NNNNNNNNNNNNNNNN 00002 NNNNNNNNNNNNNNNN PHYSICIANS LIST 00001 NNNNNNNNNNNNNNNN 00002 NNNNNNNNNNNNNNNN then display shows __ blinking 44 Press SCROLL arrows up or down to enable YES or disable NO PRINT CYCLES feature 45 Press ENTER touch pad to confirm selection Display sh...

Page 117: ...RE XX X C GENERATION MM SS DISINFECTION MM SS RINSE 1 WATER TYPE HOT RECIRC TIME MM SS RINSE 2 WATER TYPE HOT RECIRC TIME MM SS AIR PURGE RECIRC TIME MM SS 48 Once all modifications are complete press ESC touch pad once to exit Change Values menu Display shows 5 2 4 Performing Bar Code Test and Programming Operator and Physician ID Lists If bar code reader option is present refer to SECTION 2 SERV...

Page 118: ...with this information WARNING PERSONAL INJURY AND OR EQUIPMENT DAMAGE HAZARD Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment Contact STERIS to schedule preventive maintenance or obtain the necessary Maintenance Manual if preventive maintenance is done by the Customer Repairs and adjustments to this equipment must be made only by STERIS or ST...

Page 119: ...en in chamber is clean and in good condition Replace if necessary see SECTION 6 3 1 X day 3 2 Perform a D SHORT cycle see SECTION 6 5 Every 54 h 3 3 Clean chamber rotary spray arm assembly see SECTION 6 12 1 X week 3 4 Perform a D LONG cycle see SECTION 6 11 As required 3 5 Clean plastic surfaces and processor exterior panels see SECTION 6 6 1 X week 3 6 Clean steel surfaces see SECTION 6 6 1 X da...

Page 120: ... Verify pressure transducer hoses not brittle discolored cracked If damaged call STERIS 1 X week 6 0 OPTIONAL AUTOMATED LEAK TEST ASSEMBLY 6 1 Verify hose clamps for loosening or damage Replace if necessary refer to Maintenance Manual P764333 736 for details 1 X year 6 2 Using tool and grease provided in leak test hose assembly maintenance kit P117034 898 lubricate O ring inside leak test hose ass...

Page 121: ... start after 36 hours so processor is ready to use on Monday if feature has been activated in Supervisor mode If another 36 hours passes and door is still not opened and no touch pad or pushbutton is pressed once previous D SHORT cycle is completed another D SHORT will automatically start The process is continuously repeated until door is opened or touch pad or pushbutton is pressed To perform a D...

Page 122: ...o start D SHORT cycle Processor automatically proceeds through programmed phases of D SHORT cycle see Figure 6 1 for sample printout After air purge phase is complete buzzer sounds and display shows then Processor cools for 30 seconds Then display shows 12 Processor drains for 20 seconds After draining phase is completed buzzer sounds and display shows 13 Press UNLOCK toggle switch to unlock proce...

Page 123: ...LUES AUTOMATIC D SHORT screen allows operator to activate or deactivate second D SHORT starting after the 36 hours of inactivity HH MM SS MM DD YY CYCLE D SHORT CYCLE START HH MM SS XM CYCLE DATE MM DD YY CYCLE NUMBER 00000001 UNIT NUMBER 3600000000 PHASE TIME WASH 1 HH MM SS XM WATER TYPE HOT TEMPERATURE XX X RECIRC TIME MM SS AIR PURGE TEMPERATURE XXX X RECIRC TIME MM SS COMPLETED HH MM SS XM TO...

Page 124: ...using a thin wire such as a paper clip or compressed air 2 Clean two draining holes at bottom of Reliance CDS using a thin wire such as a paper clip or compressed air see Figure 6 2 3 Once a week clean venting orifice of two Allen hex screws from Reliance CDS as follows a Remove two Allen hex screws from Reliance CDS see Figure 6 2 b Using compressed air clean small orifice at center of each screw...

Page 125: ...iner is empty display shows Fault 08 CIP200 Fault 09 Klenzyme alternating with Press ALARM REPLY touch pad to silence buzzer Display shows then If Fault 08 display shows alternating with If Fault 09 display shows alternating with FAULT 08 OR 09 CYCLE DELAYED SEE FAULT CHART CYCLE DELAYED DRAINING PLEASE WAIT START TO RESUME STOP TO CANCEL CONFIRM CIP200 IS PLACED ON MIDDLE SHELF CONFIRM KLENZYME I...

Page 126: ...ctor and secure plate in feed line connector groove and locking pin groove see Figure 6 4 Detail C 13 Close Bag in a Box compartment door 14 Press START touch pad to resume cycle Display shows 15 Once cycle is in progress Klenzyme or CIP 200 cleaner injection pump automatically injects a preprogrammed amount of cleaner in solution OPERATING MMM MIN WARNING PERSONAL INJURY AND OR EQUIPMENT DAMAGE H...

Page 127: ...Not Put a Bag in a Box Container on This Shelf Drip Pan CAUTION POSSIBLEEQUIPMENT DAMAGE To ensure cleanliness during operation and to avoid damage to zinc coated steel wipe any cleaner spills or drippage inside Bag in a Box compartment Clean any surface that might have been in contact with any cleaner inside Bag in a Box compartment ...

Page 128: ...x Container Exterior Groove Snap On Closure Feed Line Connector Drip Tray Fitting Locking Plate Box and Flap With Fitting in Exterior Groove Snap On Closure Drip Tray Fitting Bag in a Box Container Interior Groove Bag in a Box Container Locking Plate Locking Pin Feed Line Connector Snap On Closure Drip Tray Fitting Detail C ...

Page 129: ...PORTANT The use of STERIS paper and ribbon cartridge is recommended Using non STERIS paper and cartridge can result in defects or other problems and can void the warranty For information on paper and cartridge to be used refer to SECTION 8 RECOMMENDED SPARE PARTS AND CONSUMABLE PRODUCTS IMPORTANT Do not change printer DIP switch settings DIP switches have been factory set by STERIS to enable data ...

Page 130: ...stem 5 Remove filter housing Using spanner wrench unscrew filter bowl from housing body counterclockwise 6 Remove filter cartridge Remove and discard old filter cartridge 7 Rinse Rinse housing bowl with clean water 8 Install new filter cartridges a For A filter Insert filter cartridge P117018 722 into housing bowl with black O ring facing up b For B filter Insert filter cartridge P117018 723 into ...

Page 131: ...ng Multi Layer Depth Media Filter Cartridge Spanner Wrench Filter Bowl Dual Layer Absolute Membrane Filter Cartridge O Ring Pressure Gauge Manual Ball Valve Lever Figure 6 6 Changing Dual Pre Filter and Pressure Regulator Assembly Cartridges Required Accessory Manual Ball Valve Lever ...

Page 132: ...ag and discard 10 To reinstall filter housing cap turn clockwise until fully tightened 11 Reconnect venting connection to filter housing cap 12 Ensure to wipe up any spilled water around filter housing and floor area 13 Reinstall service access panel with previously removed screw 14 Put processor main disconnect switch to ON position Press top portion of POWER ON OFF toggle switch to turn processo...

Page 133: ...6 16 920011 649 Operator Manual Routine Maintenance Venting Connection Housing Cap Figure 6 7 Replacing 0 2 µm Bacterial Retentive Filter Cartridge Housing Cap Turn Counterclockwise ...

Page 134: ...ts Close boots and hang buckle of middle latch on each boot but do not clasp 4 Ensure baskets valve irrigators and pegs are empty of any endoscope accessories and Flow Units 5 Open Reliance CDS Ensure a Reliance dry chemistry container IS NOT present in Reliance CDS Close Reliance CDS cover but do not clasp 6 Push endoscope processing support inside chamber 7 Close chamber door 8 Press DECONTAM to...

Page 135: ... to unlock processor door Open door 15 Check debris screen for debris Rinse screen under running water if necessary Rinse while it is still wet before any debris dries Reinstall screen REMOVE ALL ENDOSCOPES PRESS START WHEN READY OPERATING MMM MIN CYCLE COMPLETE READY TO UNLOAD WARNING CHEMICAL BURN AND OR EYE INJURY HAZARD CIP 200 Acid Based Process and Research Cleaner is corrosive and can cause...

Page 136: ...e servicing Do not service processor unless all utilities have been properly locked out Always follow local electrical codes and safety related work practices Pressing bottom portion of POWER ON OFF toggle switch to turn off processor DOES NOT cut off electrical power Lockout Tagout building electrical disconnect switch to turn off power to processor for maintenance or repairs Fasteners and star w...

Page 137: ...ce kit P117034 898 contains replacement O ring and lubrication tool required for O ring replacement 2 Using a small object such as a pin or a needle remove O ring from leak test connector 3 Once removed identify proper replacement O ring from the ones provided in leak test hose assembly maintenance kit 4 Using lubrication tool from maintenance kit install new O ring at same location of previously ...

Page 138: ...copes within the Reliance EPS Processor In that event all the leak test features would be turned off refer to SECTION 5 2 3 SETTING MISCELLANEOUS VALUES for details NOTE If display shows and or Please refer to SECTION 4 4 4 OPTIONAL AUTOMATED LEAK TEST AUDIBLE SIGNAL for details on how to respond to an audible signal IMPORTANT A listing of the Safety Precautions to be observed when operating and s...

Page 139: ...ES MUST BE REPROCESSED THROUGH A COMPLETE RELIANCE EPS CYCLE refer to SECTION 4 5 If condition reoccurs call STERIS 4 Rotary spray arms are not turning 1 Bushing not properly installed or missing on rotary spray arm hub refer to SECTION 6 12 2 Rotary spray arms are clogged clean spray arms refer to SECTION 6 12 3 ENDOSCOPES AND ACCESSORIES MUST BE REPROCESSED THROUGH A COMPLETE RELIANCE EPS CYCLE ...

Page 140: ...e insert or refer to SECTION 4 17 c ENDOSCOPES AND ACCESSORIES MUST BE REPROCESSED THROUGH A COMPLETE RELIANCE EPS CYCLE refer to SECTION 4 3 Defective Reliance CDS inlet valve a Remove any endoscopes and accessories present in control handle boot s and endoscope processing support baskets and accessory pegs b Follow disposal instructions provided in Reliance dry chemistry package insert or refer ...

Page 141: ...le inspect Flow Unit and Flow Units ports for obvious damage call STERIS 12 Abnormal quantity of water in endoscope channels ends after air purge 1 May be a normal situation if door is opened immediately after an air purge To reduce quantity of water remaining in endoscope channels increase air purge phase time refer to SECTION 5 2 2 2 Air purge pre filter needs changing call STERIS 3 Air purge HE...

Page 142: ...y line strainers are clogged Verify strainer clean if necessary 3 Dual Pre Filter and Pressure Regulator Assembly required accessory needs service a Verify last ten cycle printouts An increase of maximum filling time indicates Dual Pre Filter and Pressure Regulator Assembly cartridges are clogged Change filter cartridges refer to SECTION 6 10 1 b Perform a cycle If a situation reoccurs change 0 2 ...

Page 143: ...rnating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 05 CONDENSER OVERFLOW Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Alarm sounds and display shows FAULT 06 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 06 SUMP LEVEL SWITCH DEFECTIVE Try to resume cycle by pressing S...

Page 144: ...aring appropriate Personal Protective Equipment PPE clean Bag in a Box injection system and reinstall Bag in a Box container refer to SECTION 6 8 3 Defective cleaner pressure switch call STERIS Alarm sounds and display shows FAULT 09 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 09 KLENZYME EMPTY 1 Klenzyme Enzymatic Presoak and Cleaner Ba...

Page 145: ...T CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 12 SUMP RTD HEATING MALFUNCTION 1 Verify hot tap water HTW supply temperature as per equipment drawing 920 011 656 2 Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Alarm sounds and display shows FAULT 13 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FA...

Page 146: ...TART touch pad If situation reoccurs call STERIS FAULT 16 Not used FAULT 17 Not used FAULT 18 Not used Alarm sounds and display shows FAULT 19 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 19 BOARD RTD OVERHEAT Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Service charges may be incurred Consult your war...

Page 147: ...DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 21 SUMP RTD OVERHEAT Possible causes 1 Chamber temperature too high After a D SHORT or a D LONG cycle leave door open and allow unit and support to cool before starting a new cycle 2 Air purge pre filter needs changing call STERIS 3 Air purge HEPA filter needs changing call STERIS 4 Chamber RTD malfu...

Page 148: ...rs call STERIS Alarm sounds and display shows FAULT 25 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 25 BOOT A LOW PRESSURE 1 An endoscope of a diameter smaller than template is processed without proper insertion tube sleeve Use insertion tube sleeve in control handle boot A as per procedure refer to SECTION 4 3 2 An endoscope without a li...

Page 149: ...nsertion tube sleeve as per procedure in control handle boot B refer to SECTION 4 3 2 An endoscope without a light cord is processed without control handle boot plug Use control handle boot plug in control handle boot B as per procedure refer to SECTION 4 3 3 Only one endoscope is processed and has been put in control handle boot B instead of A refer to SECTION 4 3 4 Control handle boot is not lat...

Page 150: ...lternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 28 BOOT B PRESSURE SENSOR DEFECTIVE Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Alarm sounds and display shows FAULT 29 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 29 0 2 µm FILTER OVER PRESSURE Try to resume cy...

Page 151: ...LE DELAYED Printout message HH MM SS XM MM DD YY FAULT 31 AIR PURGE RTD HEATING MALFUNCTION Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Alarm sounds and display shows FAULT 32 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 32 BOOT A HIGH PRESSURE Possible causes 1 An endoscope of a diameter larger than ...

Page 152: ... and display shows FAULT 34 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 34 BOOT A OVER PRESSURE This message warns operator that high pressure in control handle boot A could damage endoscope IMPORTANT If high level disinfection solution remains in sump call STERIS Possible causes 1 An endoscope of a diameter larger than template is proce...

Page 153: ... 4 For a 60 Hz processor ensure there is a spacer between valve cap and valve stem 5 Try to resume cycle by pressing START touch pad If situation reoccurs call STERIS Alarm sounds and display shows FAULT 36 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 36 0 2 µm FILTER PRESSURE TOO LOW Possible causes 1 Air compressor is not generating ade...

Page 154: ...ER NOT DETECTED A new Reliance dry chemistry container was not inserted in Reliance CDS prior to cycle start Cycle is aborted Start new cycle after ensuring a new Reliance dry chemistry container is installed in Reliance CDS and ensuring latch is closed on Reliance CDS If situation reoccurs call STERIS Alarm sounds and display shows FAULT 39 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DEL...

Page 155: ...E SENSOR DEFECTIVE Press ALARM REPLY touch pad to silence audible alarm Cycle aborted users are required to restart a processing cycle If unsuccessful call STERIS Alarm sounds and display shows FAULT 42 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 42 FILLING WATER TEMPERATURE TOO HIGH 1 Verify hot tap water HTW supply temperature is as pe...

Page 156: ...ocessors Refer to Operator Manual Information Supplement For 50 Hz Processors P920501 322 for specific information Alarm sounds and display shows FAULT 46 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 46 LEAK TEST PORT 1 OVERPRESSURE Press ALARM REPLY touch pad to silence audible alarm Pressure inside endoscope 1 over maximum 4 33 psig 0 3...

Page 157: ...embly 1 not connected to endoscope 2 Major leak in endoscope 1 or in system 3 Air blockage within pneumatic block 4 Hose plug not used or removed from extremity of leak test hose assembly during self diagnostic test Go to Step 7 Cycle is automatically aborted User is required to 1 Connect endoscope if not connected and restart processing cycle If unsuccessful go to Step 2 2 Verify soaking cap of e...

Page 158: ...y during self diagnostic test Go to Step 7 Cycle is automatically aborted User is required to 1 Connect endoscope if not connected and restart processing cycle If unsuccessful go to Step 2 2 Verify soaking cap of endoscope Replace soaking cap if necessary and restart a processing cycle If unsuccessful go to Step 3 3 Perform dry leak test according to endoscope manufacturer recommendations If no le...

Page 159: ...AULT 51 LEAK TEST PORT 2 EXHAUST TOO LONG Press ALARM REPLY touch pad to silence audible alarm Possible causes 1 Exhaust valve malfunction leak test port 2 2 Air blockage within pneumatic block Cycle aborted users are required to restart a processing cycle If unsuccessful call STERIS Alarm sounds and display shows FAULT 52 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout messa...

Page 160: ...lf diagnostic test If unsuccessful go to Step 4 and Step 5 if necessary Alarm sounds and display shows FAULT 53 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout message HH MM SS XM MM DD YY FAULT 53 LEAK TEST 2 FAIL Press ALARM REPLY touch pad to silence audible alarm Pressure loss over acceptance criterion during monitoring time Possible causes 1 Endoscope leaks 2 Hose plug r...

Page 161: ...nd restart decontamination cycle If not go to Step 2 2 Verify no hose assembly is connected to processor leak test port 1 If yes remove hose assembly if not go to Step 3 3 Perform self diagnostic without hose assembly to determine if leak comes from processor system If yes call STERIS Alarm sounds and display shows FAULT 55 CYCLE DELAYED alternating with SEE FAULT CHART CYCLE DELAYED Printout mess...

Page 162: ...hows MAINTENANCE DUE alternating with MAINTENANCE 02 SEE CHART Printout message HH MM SS XM MM DD YY MAINTENANCE 02 CYCLE COUNTER EXPIRED 1 A general maintenance check is due after a preprogrammed number of cycles 2 Call STERIS for a general maintenance check 9999 cycles default determined by supervisor and set in Service mode by service technician refer to SECTION 2 SERVICE MODE PROCEDURE of Main...

Page 163: ...MM SS XM MM DD YY MAINTENANCE 04 REPLACE 0 2 µm FILTER 1 0 2 µm bacterial retentive filter cartridge must be changed 2 Replace filter cartridge refer to SECTION 6 10 2 for procedure 90 days default determined by supervisor and set in Supervisor mode by service technician refer to SECTION 5 2 SUPERVISOR MODE MAINTENANCE MESSAGE POSSIBLE CAUSE AND CORRECTION ...

Page 164: ...and adjustments to this equipment must be made only by STERIS or STERIS trained service personnel Nonroutine maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury result in improper equipment performance or result in costly damage Contact STERIS regarding service options The performance of the 510k cleared Reliance EPS Endoscope Processing...

Page 165: ...BXEC International Paper Roll Printer P117018 797 Ribbon Cartridge Printer P117018 796 Oil Silicone For Squeeze Tubes P117911 232 Pre Filter HEPA Air Purge with Two Wire Ties P117033 638 Filter HEPA Air Purge P117037 245 Dual Pre Filter and Pressure Regulator Assembly Pre FilterA Pre Filter B A1501 A1504 Processor Filter 0 2 µm Bacterial Retentive Filter Cartridge P117018 721 Filter Cartridge Comp...

Page 166: ...7910 856 Leak Test Hose Assembly Kit For Pentax Endoscopes MB00 0041 Leak Test Hose Assembly Kit For Olympus Endoscopes MB00 0042 Leak Test Hose Assembly Kit For Fujifilm Endoscopes MB00 0043 Sticker Labeled 1 and 2 P117032 993 Hose Plug Assembly For Pentax Endoscopes1 P117032 971 Hose Plug Assembly For Olympus Endoscopes P117033 484 Hose Plug Assembly For Fujifilm Endoscopes P117033 485 Leak Test...

Page 167: ......

Page 168: ...STERIS Corporation 5960 Heisley Road Mentor OH 44060 1834 USA 440 354 2600 800 548 4873 ...

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