2 Class Schedule DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break12:00 PM- Lunch2:30 PM - Break5:00 PM- End of first day
3 Class Schedule DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch2:30 PM - Break3:30 PM- End of Seminar
4 CautionsThe Renatron® 100 is intended only for use with Renalin® 100 Cold SterilantUsed only for Hemodialyzers that have been labeled multiple use.Never run the machine without the uptake tube assemblyAll hoses and lines for the Renatron® are cut to length and should not be altered.-Introduction--Talk about the other reuse machines
5 IndicationsThe Renatron® Dialyzer Reprocessing System is intended for in vitro, rinsing, cleaning testing, and delivery of proportioned Renalin® solution to hollow fiber dialyzers that have been validated to be reprocessed with the Renatron® II System and Renalin® sterilant. It is also indicated for record keeping of these functions.
7 Electrical Leakage Current 100 micro ampsSelectable voltage 100, 120, 230, 240 VACThe supply line voltage must not fluctuate more than 10% of the nominal voltage.Fuses vac, one 4AFuses vac, two T2A
8 Operation Ambient Temperature Range 41-104° F (5-40° C) Environmental LimitsOperation Ambient Temperature Range41-104° F (5-40° C)
9 Water RequirementsWater must be filtered to particle size no larger than 1 micron.Inlet Water Must Meet or Exceed AAMI Guidelines
10 Water Temperature Must be 59 -75°F (15-24° C) A maximum temperature of 86° F is allowable if the dialyzer is stored immediately after reprocessing in an area where the temperature is between 59-75° F. (Must have letter)
11 Feed Line Flow 1.725 liters (.46 gallons) per minute average Maximum water pressure is 55 PSI staticMinimum water pressure is 20 PSI dynamic read in step 4.Optimum pressure of PSI in Step 4.
12 Peak Flow Rate 6 liters (1.6 gallons) per minute 15-35 seconds in durationOccurs at approximately 3 minute intervals3 times per cycle
13 Drain RequirementsMust be able to accept 6 liters (1.6 Gallons) per minute per Renatron®.
14 Materials of Construction The drain should be constructed of PVC/CPVC or other Non-corrosive Material
16 Renatron® II Station Components Renatron® II Dialyzer Reprocessing StationHas a hydraulic side and electronic side.1 - 6 ft water supply hose with back flow preventor.1 - 6 ft drain hose.1 - 6 ft Renalin® hose.1 - 6 ft RS-232 communication cable
17 Renatron® II Station Components Pressure gauge block/regulator70 cc cal cellDrip tray-single or dualRenalin®100 Uptake tube assembly
18 Renatron® II Station Components ComputerTop of the line computer systemWindows XPMonitorVGA Monitor- CRT or Flat Screen
19 Renatron® II Station Components Renalog RM Data Management SystemDedicated label printerDedicated Report PrinterInterface ModuleMultiplexing module that can connect up to 6 Renatrons®.Renalog RM – 12 Renatrons per computer
21 End of TreatmentAfter treatment is completed, the dialyzer is brought to the reuse room.The time interval between the end of the treatment and reprocessing the dialyzer should be kept within the time limits prescribed by the physicianThe suggested maximum time interval is two hours
22 Dialyser CleaningMany clinics will clean or rinse a dialyzer before reprocessing.Blood side flushRUFRenaclear®
23 Reprocessing Attaching a dialyzer Connect: Venous blood side Venous dialysate sideArterial dialysate sideArterial blood side
24 End of Reprocessing Cycle Make sure reset is pressed before the dialyzer is disconnected.Disconnect the dialyzer in the reverse order that it was connected. Cap each port as soon as it is disconnected from the Renatron®.Aseptic technique must be followed while removing the reprocessed dialyzer from the Renatron® station to prevent contamination of the dialyzer blood pathway
25 Dialyzer Storage Storage Area Dialyzer Storage Well ventilated Temp. range 59-75°FOut of direct Sun lightDialyzer StorageMinimum storage time is 11 hoursMaximum storage time ?Temperature differences may cause pressure buildup in dialyzer
26 Dialyzer Testing before Treatment The dialyzer must be tested for Renalin® 100 content after proper storage time- Perrassay Test StripThe dialyzer is rinsed on the dialysis machine and a Residual Test Strip is used to verify that the Renalin® 100 content has been rinsed to acceptable levelsRecirculate until treatment is started to prevent rebound
28 Power Up Sequence Power on sequence PrintersMonitorComputerInterface moduleRenatron® IIAll at once if using the power strip
29 Renalog® RM Start Up Log in Start Up Screens User ID Password Mode Change Time- Activation key neededStart Up ScreensRenalin VerificationsService RinseSanitize RenatronsCalibrationWater Verifications- 20 psi to 55 psiWater CulturesDialyzer Verifications- Precleaned, Expired, and not Processed
30 Renatron® II 100 Startup Renalog® RM Startup Renalin® 100 is connected The Renatron® II 100 is sanitizedThe Renatron® II 100 is calibratedStatic and dynamic water pressure readings
31 Renatron® II 100 Startup Calibration verification Scan barcodes- Authentication label, Renatron, and DialyzerThe Renatron® II 100 runs to step 57Calibration information is stored in the computer and a calibration report can be generated.
33 Program ModeLow flux dialyzers (00) kuf <8. Program time = 8 minutes.High efficiency dialyzers (CH) kuf Program time= 10 minutes.High flux dialyzers (HF) kuf 15+. Program time = 10 minutes.
34 Automatic Reprocessing Scan Authentication label, dialyzer barcode label, and Renatron® barcode.Minimum VolumeProgram ModeWhen reset is pressed in step 57, labels are printed and the database is updated.
35 Semi-Automatic Click on F6 to display Patient list Select patient’s dialyzerSelect type of reprocessingPrecleanReprocess without a useReprocess after useSets the Renatron® II 100 to the proper settings for that dialyzer
36 Manual Reprocessing With Computer Process dialyzer on Renatron® II 100Set Hold to Set volume to dialyzer minimum volume settingPress mute and reset button to select program settingAt end of cycle, enter information into computerPreprocessReprocess without useReprocess after useRenatron numberContainer numberCurrent VolumeDid the dialyzer fail?
37 Manual Reprocessing with Renatron® II 100 only Process dialyzer on Renatron® II 100Set Hold to Set volume to dialyzer minimum volumePress mute and reset button to select program settingAt end of cycle, hand write label
39 Pre-clean ModePre-cleaning a dialyzer will help breakdown residual blood in the dialyzer.Pre-clean program works for all types of dialyzers. Program time 4 minutes.Recommended contact time for pre-cleaned dialyzers is 10 minutes to two hours.
40 Caution Pressure buildup may occur in dialyzers left on the Renatron® Take care when removing the dialyzerPressure buildup may cause fluid to spray
41 Barcode labels User Authentication Label Information Label Dialyzer Barcode LabelPre-Cleaned LabelCalibration Cell LabelFailed Label
43 Daily Sanitize The Renatron needs to be sanitized once a day. The machine must be connected in sanitize configuration. “SEL” must be in the top display and any of the programs “00”, “CH” or “HF” in the bottom display before “Start Sanitize” is pressedThe machine will display “sanitize complete” and a 3 second tone will sound at the end of step 83.Turn off the Renatron and the water supply to the Renatron.
44 Minimum Sanitize TimeThe Renatron must sit for a minimum of 6 hours before it can be used.
45 Maximum Sanitize TimeThe Renatron® can sit for a maximum of seven days before it needs to be resanitized.
46 10 Minute Sanitize CyclePress start process at the end of step 83, after a 10 minute hold in step 84, the machine will run to step 97, and signal sanitize complete. All fluid will be removed from the machine.This cycle is to be used after a 409® procedure, when maintenance is performed on the machine, or when the machine is being returned for maintenance.
47 External Disinfection (Daily) 1 % Renalin® solution is used to wipe down external surfaces of the Renatron® stationActril® undiluted is also acceptable
49 409® Cleaning Institutional Formula 409® Institutional Formula 409® Cleaner Degreaser onlyMust say NQFDo not use any other solutionsInternal fluid pathways must be cleaned periodically ( typically once every two weeks )This should be performed on Saturday a long dwell time is preferred
50 409® CleaningInstitutional Formula 409® is free when Renalin® 100 is ordered in proper quantities
52 Cleaning Cycle Step 8 to 24 Chemical Draw- Step 9 Flush Blood Circuit Arterial to Venous-Step 14Reverse Ultrafiltration- Steps 16 and 18Flush Dialysate Compartment- Step 20Flush Blood Circuit (Arterial to Venous)-Step 21Flush Blood Circuit (Venous to Arterial)-Step 25
53 Test- Step 25 to 40 Blood Compartment Volume Measurement Step 25 to 35 Fill Blood Compartment from venous to arterial- Step 25Sweep Blood Compartment- Steps 29, 31 and 33Measure Mass- Step 35Repeatability ± 5%
54 Test- Step 25 to 40 Pressure Leak Test- Steps 36 to 39 Draw vacuum- Steps 36 and 38Measure bleed off rate- Step 39Dialysate compartment is at -250 mmHg or lessBlood compartment atmospheric pressureLeakage rate of .83mmHg per second fails ± 10 % for 00, CH modeLeakage rate of 1.25mmHg per second fails ± 10% for HF program
57 Interface Module Yellow power indicator light. Green On Line light- Indicates that the computer is in communication mode. This light will only be on in the Automatic Reprocessing, Automatic Calibrations, or Renalin Connection screens.On/Off switch and fuse at power entry module.Older version of scanner will beep twice when scanning.The newer version of the scanner will beep once when scanning.
58 ScannerFor best operation of Scan Team 3000 and 3400 models, hold the scanner so it is touching the barcode and press the trigger. Continue to press the trigger while moving the scanner away form the barcode until the scanner beeps.Scan Team 3800 models, hold the scanner 3-9 inches from the barcode.Make sure scanner lens is clean.Clean the scanner with a nonabrasive cloth. Do not use a cleaner that contains alcohol.
60 Label PrinterShould be connected to the computer with a Parallel Printer Cable.If printing is not aligned on label, perform the Calibration Procedure.Turn power switch to OffHold Green Button downTurn Power switch to OnLet go of Green Button when the red light flashesPress Green Button to get “out of dump” labelRed light means that:Cover is not completely closedRibbon is not advancingLabels are not advancing
62 Description of Controls OffHold to SetSet KnobStart ProcessStart SanitizeMuteResetDisplay
63 Indicators Volume Display Program Step Clean Test Disinfect Process CompleteSanitize Complete
64 Error Messages Volume Fail- Step 35 Pressure Fail- Steps 36, 38, or 39 Add Chemical- Steps 9, 45, 67, or 77Tank Volume- Many steps throughout the programAlarmInterlock
65 Safety Features Tracks Preclean Dialyzers Tracks Maximum storage time Tracks Dialyzers that have not been processed- Preprocessed and Dry PacksInformation stored on hard drivePrecautions for similar name patientsPatient data and program settings are password protected
66 Renatron® Storage Long term storage run machine through step 97 to ensure fluid pathways are drainedBox in Renatron® boxKeep in low traffic area
67 Technical Service Telephone Support 24 hours a day 7 days a week Press “2” for “Medical Equipment Emergency” to get a live personServiceLoaners available upon requestBoard exchanges for $200RMA’s must accompany all returns
68 Warranty / Promotions Warranty Promotions 1 year warranty from date of install90 days for service warranty90 days for parts ordersPromotionsPM contractsService contracts
70 Warnings Corrosive. Use universal precautions. Can cause eye damage and skin irritation.When handling Renalin®100, wear eye protection, rubber gloves and protective clothing.Do not mix Renalin®100 with alkaline substances such as bleach.
71 IndicationsRenalin® 100 Cold Sterilant is indicated for the in vitro cleaning and sterilizing of hollow fiber dialyzers with the RS8300 and RS8330 models of the Renatron® Dialyzer Reprocessing System labeled for use with Renalin®100. Renalin®100 Cold Sterilant also may be used for disinfecting dialysis equipment (e.g. kidney machines) and supplies (e.g. port caps).
72 ContraindicationsRenalin® 100 Cold Sterilant is not designed, sold, or intended for use except as indicated.Patients with known hypersensitivity to hydrogen peroxide and/or peroxyacetic acid should not be treated using dialyzers reprocessed with Renalin® 100 Cold Sterilant.
73 Water RequirementsAAMI quality water filtered to particle size no larger than 1 micronWater temperature should be between59-75° FWater Temperature may be up to 86° F if the dialyzers are stored at the proper temperature
74 Renalin®100 Storage Never replace the vented cap with a nonvented cap UprightNever in direct sunlightAt temperatures between 32-75° FDo not freezeNever tamper with the capNever replace the vented cap with a nonvented capRenalin® can be removed from the shipping carton if it is not stored in direct sunlight
75 Renalin® 100 Active ingredients Renalin® 100 replaces Formaldehyde Bleach and/or hydrogen peroxideActive ingredientsHydrogen peroxidePeroxyacetic acidAcetic acidRenalin® 100 degrades quickly and will not harm the environment. It breaks down into ; oxygen, water, and acetic acid.
76 Renalin 100® Renalin® 100 is supplied in three different volumes: Quart bottles2.5 gallon bottles that contain 2 liters of Renalin® concentrate1 gallon bottles containing 3 liters of Renalin® 100
77 Renalin® Nomenclature Renalin® 100 Cold Sterilant is a 100% Renalin® Solution.Proportioned Renalin® - A 3.25% or 3.5% Renalin® solution that is used to sterilize the reprocessed dialyzer.1% Renalin® solution- A solution made from 1 part Renalin® concentrate and 99 parts AAMI quality water.
78 Renalin® Nomenclature 4% Renalin® solution is used to sanitize the Renatron®2% Renalin® solution is used during the preclean program
79 Auto DilutorThe On Demand™ Auto Dilution System proportions Renalin® 100 Cold Sterilant and dispenses a continuous supply of 1% Renalin solution.
80 Shelf LifeRenalin® 100 has a shelf life of 1 year from date of manufacture when properly stored.Following dilution, Renalin® 100 exhibits a gradual loss of potency at a rate such that 50% of the active ingredients remain after a seven day period
81 Shelf LifeWhen diluting Renalin® Cold Sterilant to a 1% solution (e.g. port cap disinfection) fresh Renalin® Cold Sterilant should be used each time. Do not allow 1% Renalin® solution to sit for longer than 24 hours.
82 Test Strips Perassay Test Strip Simple go/no go test Indicates a 1% Renalin® solutionGreen stick for identificationDo not need to be refrigerated
83 Test Strips Residual Test Strip Color chart for interpreting test resultsDo not need to be refrigeratedVerifies the proportioned Renalin® solution has been properly rinsed from the dialyzer prior to clinical use
84 Renalin® 100 Presence Test (Perassay) Remove 1 ml of solution from the dialysate port of the dialyzerImmerse the entire reaction pad of the Perassay strip in the solutionShake off excess solutionRead the reaction pad after 2-5 seconds. The test strip should turn a blue/gray or blue/black color. This will indicate 500 PPM of peracetic acid 1% Renalin® solution.
85 Renalin® 100 Residual Test Strips Turn off the blood pump and clamp the arterial and venous blood lines adjacent to the access ends. Separate the blood lines where the access ends are joined and unclamp the venous blood line.Allow a few drops of saline to drip from the venous line onto the residual test strip.After 5 seconds, shake the excess liquid from the reaction zone and compare with the color scale on the container.Per AAMI standards, a reading of less than 3 PPM is acceptable
86 Handling and Storage of Reprocessed Dialyzers If a dialyzer is foaming after being reprocessed it should be reprocessed again without a useStore a reprocessed dialyzer in a cool, well ventilated area that is shielded from any direct sunlight. Recommended temperature range is 59-75° FA reprocessed dialyzer should not be used until a minimum of 11 hours has elapsedAfter storage and before rinsing, both headers of the dialyzers must be at least 2/3 full
87 Renalin® SpillFlush spill with large quantities of water and also consult the handout “What to do if Renalin® spills”After hours, contact Chemtrec for emergency spill information at( in the Washington D.C. area)