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Renatron® II Service Maintenance Seminar. Class Schedule DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break.

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Presentation on theme: "Renatron® II Service Maintenance Seminar. Class Schedule DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break."— Presentation transcript:

1 Renatron® II Service Maintenance Seminar

2 Class Schedule DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 5:00 PM- End of first day DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 5:00 PM- End of first day

3 Class Schedule DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 3:30 PM- End of Seminar DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 3:30 PM- End of Seminar

4 Cautions n The Renatron ® 100 is intended only for use with Renalin ® 100 Cold Sterilant n Used only for Hemodialyzers that have been labeled multiple use. n Never run the machine without the uptake tube assembly n All hoses and lines for the Renatron ® are cut to length and should not be altered. n The Renatron ® 100 is intended only for use with Renalin ® 100 Cold Sterilant n Used only for Hemodialyzers that have been labeled multiple use. n Never run the machine without the uptake tube assembly n All hoses and lines for the Renatron ® are cut to length and should not be altered.

5 Indications The 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.

6 Specifications

7 Electrical Leakage Current n 100 micro amps n Selectable voltage 100, 120, 230, 240 VAC n The supply line voltage must not fluctuate more than 10% of the nominal voltage. n Fuses vac, one 4A n Fuses vac, two T2A n 100 micro amps n Selectable voltage 100, 120, 230, 240 VAC n The supply line voltage must not fluctuate more than 10% of the nominal voltage. n Fuses vac, one 4A n Fuses vac, two T2A

8 Environmental Limits n Operation Ambient Temperature Range ° F (5-40° C) n Operation Ambient Temperature Range ° F (5-40° C)

9 Water Requirements n Water must be filtered to particle size no larger than 1 micron. Inlet Water Must Meet or Exceed AAMI Guidelines n Water must be filtered to particle size no larger than 1 micron. Inlet Water Must Meet or Exceed AAMI Guidelines

10 Water Temperature n Must be °F (15-24° C) n 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) n Must be °F (15-24° C) n 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 n liters (.46 gallons) per minute average n Maximum water pressure is 55 PSI static n Minimum water pressure is 20 PSI dynamic read in step 4. n Optimum pressure of PSI in Step 4. n liters (.46 gallons) per minute average n Maximum water pressure is 55 PSI static n Minimum water pressure is 20 PSI dynamic read in step 4. n Optimum pressure of PSI in Step 4.

12 Peak Flow Rate n 6 liters (1.6 gallons) per minute n seconds in duration n Occurs at approximately 3 minute intervals n 3 times per cycle n 6 liters (1.6 gallons) per minute n seconds in duration n Occurs at approximately 3 minute intervals n 3 times per cycle

13 Drain Requirements Must 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

15 Renatron II Station Components

16 Renatron ® II Station Components n Renatron ® II Dialyzer Reprocessing Station 3 Has a hydraulic side and electronic side ft water supply hose with back flow preventor ft drain hose ft Renalin ® hose ft RS-232 communication cable n Renatron ® II Dialyzer Reprocessing Station 3 Has a hydraulic side and electronic side ft water supply hose with back flow preventor ft drain hose ft Renalin ® hose ft RS-232 communication cable

17 Renatron ® II Station Components n Pressure gauge block/regulator n 70 cc cal cell n Drip tray-single or dual n Renalin®100 Uptake tube assembly n Pressure gauge block/regulator n 70 cc cal cell n Drip tray-single or dual n Renalin®100 Uptake tube assembly

18 Renatron ® II Station Components nComputer 3Top of the line computer system 3Windows XP Monitor n VGA Monitor- CRT or Flat Screen nComputer 3Top of the line computer system 3Windows XP Monitor n VGA Monitor- CRT or Flat Screen

19 Renatron ® II Station Components nRenalog RM Data Management System 3Dedicated label printer 3Dedicated Report Printer n Interface Module 3 Multiplexing module that can connect up to 6 Renatrons®. 3Renalog RM – 12 Renatrons per computer nRenalog RM Data Management System 3Dedicated label printer 3Dedicated Report Printer n Interface Module 3 Multiplexing module that can connect up to 6 Renatrons®. 3Renalog RM – 12 Renatrons per computer

20 Overview of Dialyzer Reprocessing

21 End of Treatment nAfter treatment is completed, the dialyzer is brought to the reuse room. nThe time interval between the end of the treatment and reprocessing the dialyzer should be kept within the time limits prescribed by the physician n The suggested maximum time interval is two hours nAfter treatment is completed, the dialyzer is brought to the reuse room. nThe time interval between the end of the treatment and reprocessing the dialyzer should be kept within the time limits prescribed by the physician n The suggested maximum time interval is two hours

22 Dialyser Cleaning nMany clinics will clean or rinse a dialyzer before reprocessing. 3Blood side flush 3RUF 3 Renaclear® nMany clinics will clean or rinse a dialyzer before reprocessing. 3Blood side flush 3RUF 3 Renaclear®

23 Reprocessing n Attaching a dialyzer Connect: 3Venous blood side 3Venous dialysate side 3Arterial dialysate side 3Arterial blood side n Attaching a dialyzer Connect: 3Venous blood side 3Venous dialysate side 3Arterial dialysate side 3Arterial blood side

24 End of Reprocessing Cycle n Make sure reset is pressed before the dialyzer is disconnected. n Disconnect the dialyzer in the reverse order that it was connected. Cap each port as soon as it is disconnected from the Renatron ®. n Aseptic technique must be followed while removing the reprocessed dialyzer from the Renatron ® station to prevent contamination of the dialyzer blood pathway n Make sure reset is pressed before the dialyzer is disconnected. n Disconnect the dialyzer in the reverse order that it was connected. Cap each port as soon as it is disconnected from the Renatron ®. n 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 n Storage Area 3 Well ventilated 3 Temp. range 59-75°F 3 Out of direct Sun light n Dialyzer Storage 3 Minimum storage time is 11 hours 3 Maximum storage time ? 3 Temperature differences may cause pressure buildup in dialyzer n Storage Area 3 Well ventilated 3 Temp. range 59-75°F 3 Out of direct Sun light n Dialyzer Storage 3 Minimum storage time is 11 hours 3 Maximum storage time ? 3 Temperature differences may cause pressure buildup in dialyzer

26 Dialyzer Testing before Treatment nThe dialyzer must be tested for Renalin® 100 content after proper storage time- Perrassay Test Strip nThe 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 levels nRecirculate until treatment is started to prevent rebound nThe dialyzer must be tested for Renalin® 100 content after proper storage time- Perrassay Test Strip nThe 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 levels nRecirculate until treatment is started to prevent rebound

27 RENATRON ® II SYSTEM OPERATION

28 Power Up Sequence n Power on sequence 3 Printers 3 Monitor 3 Computer 3 Interface module 3 Renatron ® II n All at once if using the power strip n Power on sequence 3 Printers 3 Monitor 3 Computer 3 Interface module 3 Renatron ® II n All at once if using the power strip

29 Renalog® RM Start Up  Log in 3User ID Password Mode Change Time- Activation key needed  Start Up Screens Renalin Verifications Service Rinse Sanitize Renatrons Calibration Water Verifications- 20 psi to 55 psi Water Cultures Dialyzer Verifications- Precleaned, Expired, and not Processed  Log in 3User ID Password Mode Change Time- Activation key needed  Start Up Screens Renalin Verifications Service Rinse Sanitize Renatrons Calibration Water Verifications- 20 psi to 55 psi Water Cultures Dialyzer Verifications- Precleaned, Expired, and not Processed

30 Renatron ® II 100 Startup nRenalog® RM Startup 3Renalin® 100 is connected 3The Renatron® II 100 is sanitized 3The Renatron® II 100 is calibrated 3Static and dynamic water pressure readings nRenalog® RM Startup 3Renalin® 100 is connected 3The Renatron® II 100 is sanitized 3The Renatron® II 100 is calibrated 3Static and dynamic water pressure readings

31 Renatron ® II 100 Startup nCalibration verification 3Scan barcodes- Authentication label, Renatron, and Dialyzer 3The Renatron® II 100 runs to step 57 3Calibration information is stored in the computer and a calibration report can be generated. nCalibration verification 3Scan barcodes- Authentication label, Renatron, and Dialyzer 3The Renatron® II 100 runs to step 57 3Calibration information is stored in the computer and a calibration report can be generated.

32 Modes of Operation

33 Program Mode n Low flux dialyzers (00) kuf <8. Program time = 8 minutes. n High efficiency dialyzers (CH) kuf Program time= 10 minutes. n High flux dialyzers (HF) kuf 15+. Program time = 10 minutes. n Low flux dialyzers (00) kuf <8. Program time = 8 minutes. n High efficiency dialyzers (CH) kuf Program time= 10 minutes. n High flux dialyzers (HF) kuf 15+. Program time = 10 minutes.

34 Automatic Reprocessing n Scan Authentication label, dialyzer barcode label, and Renatron ® barcode. 3 Minimum Volume 3 Program Mode n When reset is pressed in step 57, labels are printed and the database is updated. n Scan Authentication label, dialyzer barcode label, and Renatron ® barcode. 3 Minimum Volume 3 Program Mode n When reset is pressed in step 57, labels are printed and the database is updated.

35 Semi-Automatic n Click on F6 to display Patient list 3 Select patient’s dialyzer 3 Select type of reprocessing n Preclean n Reprocess without a use n Reprocess after use n Sets the Renatron ® II 100 to the proper settings for that dialyzer n Click on F6 to display Patient list 3 Select patient’s dialyzer 3 Select type of reprocessing n Preclean n Reprocess without a use n Reprocess after use n Sets the Renatron ® II 100 to the proper settings for that dialyzer

36 Manual Reprocessing With Computer nProcess dialyzer on Renatron® II 100 3Set Hold to Set volume to dialyzer minimum volume setting 3 Press mute and reset button to select program setting n At end of cycle, enter information into computer 3Preprocess 3Reprocess without use 3Reprocess after use 3Renatron number 3Container number 3Current Volume 3Did the dialyzer fail? nProcess dialyzer on Renatron® II 100 3Set Hold to Set volume to dialyzer minimum volume setting 3 Press mute and reset button to select program setting n At end of cycle, enter information into computer 3Preprocess 3Reprocess without use 3Reprocess after use 3Renatron number 3Container number 3Current Volume 3Did the dialyzer fail?

37 Manual Reprocessing with Renatron® II 100 only nProcess dialyzer on Renatron® II 100 3Set Hold to Set volume to dialyzer minimum volume 3 Press mute and reset button to select program setting n At end of cycle, hand write label nProcess dialyzer on Renatron® II 100 3Set Hold to Set volume to dialyzer minimum volume 3 Press mute and reset button to select program setting n At end of cycle, hand write label

38 Preclean Mode

39 Pre-clean Mode nPre-cleaning a dialyzer will help breakdown residual blood in the dialyzer. nPre-clean program works for all types of dialyzers. Program time  4 minutes. nRecommended contact time for pre-cleaned dialyzers is 10 minutes to two hours. nPre-cleaning a dialyzer will help breakdown residual blood in the dialyzer. nPre-clean program works for all types of dialyzers. Program time  4 minutes. nRecommended contact time for pre-cleaned dialyzers is 10 minutes to two hours.

40 Caution n Pressure buildup may occur in dialyzers left on the Renatron ® 3 Take care when removing the dialyzer 3 Pressure buildup may cause fluid to spray n Pressure buildup may occur in dialyzers left on the Renatron ® 3 Take care when removing the dialyzer 3 Pressure buildup may cause fluid to spray

41 Barcode labels Dialyzer Barcode Label Information Label User Authentication Label Pre-Cleaned Label Calibration Cell Label Failed Label

42 Sanitize Program

43 Daily Sanitize nThe Renatron  needs to be sanitized once a day. nThe 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 pressed nThe machine will display “sanitize complete” and a 3 second tone will sound at the end of step 83. nTurn off the Renatron  and the water supply to the Renatron . nThe Renatron  needs to be sanitized once a day. nThe 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 pressed nThe machine will display “sanitize complete” and a 3 second tone will sound at the end of step 83. nTurn off the Renatron  and the water supply to the Renatron .

44 Minimum Sanitize Time nThe Renatron  must sit for a minimum of 6 hours before it can be used.

45 Maximum Sanitize Time The Renatron ® can sit for a maximum of seven days before it needs to be resanitized.

46 10 Minute Sanitize Cycle nPress 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. nThis 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. nPress 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. nThis 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) n 1 % Renalin ® solution is used to wipe down external surfaces of the Renatron ® station 3 Actril ® undiluted is also acceptable n 1 % Renalin ® solution is used to wipe down external surfaces of the Renatron ® station 3 Actril ® undiluted is also acceptable

48 Formula 409  Cleaning

49 409 ® Cleaning n Institutional Formula 409 ® 3 Institutional Formula 409 ® Cleaner Degreaser only 3 Must say NQF 3 Do not use any other solutions n Internal fluid pathways must be cleaned periodically ( typically once every two weeks ) 3 This should be performed on Saturday a long dwell time is preferred n Institutional Formula 409 ® 3 Institutional Formula 409 ® Cleaner Degreaser only 3 Must say NQF 3 Do not use any other solutions n Internal fluid pathways must be cleaned periodically ( typically once every two weeks ) 3 This should be performed on Saturday a long dwell time is preferred

50 409 ® Cleaning n Institutional Formula 409 ® is free when Renalin® 100 is ordered in proper quantities

51 Dialyzer Reprocessing Cycle

52 Cleaning Cycle Step 8 to 24 n Chemical Draw- Step 9 n Flush Blood Circuit Arterial to Venous-Step 14 n Reverse Ultrafiltration- Steps 16 and 18 n Flush Dialysate Compartment- Step 20 n Flush Blood Circuit (Arterial to Venous)-Step 21 n Flush Blood Circuit (Venous to Arterial)-Step 25 n Chemical Draw- Step 9 n Flush Blood Circuit Arterial to Venous-Step 14 n Reverse Ultrafiltration- Steps 16 and 18 n Flush Dialysate Compartment- Step 20 n Flush Blood Circuit (Arterial to Venous)-Step 21 n Flush Blood Circuit (Venous to Arterial)-Step 25

53 Test- Step 25 to 40 Blood Compartment Volume Measurement Step 25 to 35 n Fill Blood Compartment from venous to arterial- Step 25 n Sweep Blood Compartment- Steps 29, 31 and 33 nMeasure Mass- Step 35 3 Repeatability ± 5% n Fill Blood Compartment from venous to arterial- Step 25 n Sweep Blood Compartment- Steps 29, 31 and 33 nMeasure Mass- Step 35 3 Repeatability ± 5%

54 Test- Step 25 to 40 Pressure Leak Test- Steps 36 to 39 nDraw vacuum- Steps 36 and 38 nMeasure bleed off rate- Step 39 3Dialysate compartment is at -250 mmHg or less 3 Blood compartment atmospheric pressure 3 Leakage rate of.83mmHg per second fails ± 10 % for 00, CH mode 3 Leakage rate of 1.25mmHg per second fails ± 10% for HF program nDraw vacuum- Steps 36 and 38 nMeasure bleed off rate- Step 39 3Dialysate compartment is at -250 mmHg or less 3 Blood compartment atmospheric pressure 3 Leakage rate of.83mmHg per second fails ± 10 % for 00, CH mode 3 Leakage rate of 1.25mmHg per second fails ± 10% for HF program

55 Disinfect- Steps 41 to 57 n Draw Renalin ® - Step 45 nVerify Renalin ® Draw- Steps 46 and 47 n Proportion Renalin ® solution- Step 48 n Flush Blood Compartment- Step 50 nFlush Dialysate Compartment- Step 51 n Draw Renalin ® Solution to Dialysate Compartment- Step 53 n Draw Renalin ® Solution to Blood Compartment- Step 54 n Draw Renalin ® - Step 45 nVerify Renalin ® Draw- Steps 46 and 47 n Proportion Renalin ® solution- Step 48 n Flush Blood Compartment- Step 50 nFlush Dialysate Compartment- Step 51 n Draw Renalin ® Solution to Dialysate Compartment- Step 53 n Draw Renalin ® Solution to Blood Compartment- Step 54

56 Interface Module/Scanner Operation

57 Interface Module nYellow power indicator light. nGreen 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. nOn/Off switch and fuse at power entry module. nOlder version of scanner will beep twice when scanning. nThe newer version of the scanner will beep once when scanning. nYellow power indicator light. nGreen 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. nOn/Off switch and fuse at power entry module. nOlder version of scanner will beep twice when scanning. nThe newer version of the scanner will beep once when scanning.

58 Scanner nFor 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. nScan Team 3800 models, hold the scanner 3-9 inches from the barcode. nMake sure scanner lens is clean. nClean the scanner with a nonabrasive cloth. Do not use a cleaner that contains alcohol. nFor 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. nScan Team 3800 models, hold the scanner 3-9 inches from the barcode. nMake sure scanner lens is clean. nClean the scanner with a nonabrasive cloth. Do not use a cleaner that contains alcohol.

59 Renalog® RM Label Printer

60 Label Printer  Should 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 Off Hold Green Button down Turn Power switch to On Let go of Green Button when the red light flashes Press Green Button to get “out of dump” label  Red light means that: Cover is not completely closed Ribbon is not advancing Labels are not advancing

61 Renatron® II 100 Controls and Indicators

62 Description of Controls nOn nOff nHold to Set 3Set Knob nStart Process nStart Sanitize nMute nReset nDisplay nOn nOff nHold to Set 3Set Knob nStart Process nStart Sanitize nMute nReset nDisplay

63 Indicators nVolume Display nProgram Step nClean nTest nDisinfect nProcess Complete nSanitize Complete nVolume Display nProgram Step nClean nTest nDisinfect nProcess Complete nSanitize Complete

64 Error Messages nVolume Fail- Step 35 nPressure Fail- Steps 36, 38, or 39 nAdd Chemical- Steps 9, 45, 67, or 77 nTank Volume- Many steps throughout the program nAlarm nInterlock nVolume Fail- Step 35 nPressure Fail- Steps 36, 38, or 39 nAdd Chemical- Steps 9, 45, 67, or 77 nTank Volume- Many steps throughout the program nAlarm nInterlock

65 Safety Features n Tracks Preclean Dialyzers n Tracks Maximum storage time n Tracks Dialyzers that have not been processed- Preprocessed and Dry Packs n Information stored on hard drive n Precautions for similar name patients n Patient data and program settings are password protected n Tracks Preclean Dialyzers n Tracks Maximum storage time n Tracks Dialyzers that have not been processed- Preprocessed and Dry Packs n Information stored on hard drive n Precautions for similar name patients n Patient data and program settings are password protected

66 Renatron ® Storage n Long term storage 3 run machine through step 97 to ensure fluid pathways are drained 3 Box in Renatron ® box 3 Keep in low traffic area n Long term storage 3 run machine through step 97 to ensure fluid pathways are drained 3 Box in Renatron ® box 3 Keep in low traffic area

67 Technical Service n Telephone Support 24 hours a day 7 days a week Press “2” for “Medical Equipment Emergency” to get a live person n Service 3 Loaners available upon request 3 Board exchanges for $200 3 RMA’s must accompany all returns n Telephone Support 24 hours a day 7 days a week Press “2” for “Medical Equipment Emergency” to get a live person n Service 3 Loaners available upon request 3 Board exchanges for $200 3 RMA’s must accompany all returns

68 Warranty / Promotions n Warranty 3 1 year warranty from date of install 3 90 days for service warranty 3 90 days for parts orders n Promotions 3 PM contracts 3 Service contracts n Warranty 3 1 year warranty from date of install 3 90 days for service warranty 3 90 days for parts orders n Promotions 3 PM contracts 3 Service contracts

69 Renalin® 100

70 Warnings n Corrosive. n Use universal precautions. n Can cause eye damage and skin irritation. n When handling Renalin ®100, wear eye protection, rubber gloves and protective clothing. n Do not mix Renalin ®100 with alkaline substances such as bleach. n Corrosive. n Use universal precautions. n Can cause eye damage and skin irritation. n When handling Renalin ®100, wear eye protection, rubber gloves and protective clothing. n Do not mix Renalin ®100 with alkaline substances such as bleach.

71 Indications Renalin ® 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 Contraindications Renalin ® 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. Renalin ® 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 Requirements n AAMI quality water filtered to particle size no larger than 1 micron n Water temperature should be between 59-75° F n Water Temperature may be up to 86° F if the dialyzers are stored at the proper temperature n AAMI quality water filtered to particle size no larger than 1 micron n Water temperature should be between 59-75° F n Water Temperature may be up to 86° F if the dialyzers are stored at the proper temperature

74 Renalin®100 Storage n Renalin®100 Storage 3Upright 3Never in direct sunlight 3At temperatures between 32-75° F 3Do not freeze n Never tamper with the cap n Never replace the vented cap with a nonvented cap nRenalin® can be removed from the shipping carton if it is not stored in direct sunlight n Renalin®100 Storage 3Upright 3Never in direct sunlight 3At temperatures between 32-75° F 3Do not freeze n Never tamper with the cap n Never replace the vented cap with a nonvented cap nRenalin® can be removed from the shipping carton if it is not stored in direct sunlight

75 Renalin ® 100 n Renalin ® 100 replaces 3Formaldehyde 3Bleach and/or hydrogen peroxide n Active ingredients 3Hydrogen peroxide 3Peroxyacetic acid 3Acetic acid n Renalin® 100 degrades quickly and will not harm the environment. It breaks down into ; oxygen, water, and acetic acid. n Renalin ® 100 replaces 3Formaldehyde 3Bleach and/or hydrogen peroxide n Active ingredients 3Hydrogen peroxide 3Peroxyacetic acid 3Acetic acid n Renalin® 100 degrades quickly and will not harm the environment. It breaks down into ; oxygen, water, and acetic acid.

76 Renalin 100 ® n Renalin ® 100 is supplied in three different volumes: 3Quart bottles 32.5 gallon bottles that contain 2 liters of Renalin ® concentrate 31 gallon bottles containing 3 liters of Renalin ® 100 n Renalin ® 100 is supplied in three different volumes: 3Quart bottles 32.5 gallon bottles that contain 2 liters of Renalin ® concentrate 31 gallon bottles containing 3 liters of Renalin ® 100

77 Renalin ® Nomenclature nRenalin ® 100 Cold Sterilant is a 100% Renalin ® Solution. nProportioned Renalin ® - A 3.25% or 3.5% Renalin ® solution that is used to sterilize the reprocessed dialyzer. n1% Renalin ® solution- A solution made from 1 part Renalin ® concentrate and 99 parts AAMI quality water. nRenalin ® 100 Cold Sterilant is a 100% Renalin ® Solution. nProportioned Renalin ® - A 3.25% or 3.5% Renalin ® solution that is used to sterilize the reprocessed dialyzer. n1% Renalin ® solution- A solution made from 1 part Renalin ® concentrate and 99 parts AAMI quality water.

78 Renalin ® Nomenclature n4% Renalin ® solution is used to sanitize the Renatron ® n 2% Renalin ® solution is used during the preclean program n4% Renalin ® solution is used to sanitize the Renatron ® n 2% Renalin ® solution is used during the preclean program

79 Auto Dilutor The On Demand™ Auto Dilution System proportions Renalin® 100 Cold Sterilant and dispenses a continuous supply of 1% Renalin solution.

80 Shelf Life nRenalin® 100 has a shelf life of 1 year from date of manufacture when properly stored. nFollowing 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 nRenalin® 100 has a shelf life of 1 year from date of manufacture when properly stored. nFollowing 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 Life When 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 n Perassay Test Strip 3Simple go/no go test 3Indicates a 1% Renalin ® solution 3Green stick for identification 3Do not need to be refrigerated n Perassay Test Strip 3Simple go/no go test 3Indicates a 1% Renalin ® solution 3Green stick for identification 3Do not need to be refrigerated

83 Test Strips n Residual Test Strip 3 Color chart for interpreting test results 3Do not need to be refrigerated 3Verifies the proportioned Renalin ® solution has been properly rinsed from the dialyzer prior to clinical use n Residual Test Strip 3 Color chart for interpreting test results 3Do not need to be refrigerated 3Verifies the proportioned Renalin ® solution has been properly rinsed from the dialyzer prior to clinical use

84 Renalin ® 100 Presence Test (Perassay) n Remove 1 ml of solution from the dialysate port of the dialyzer n Immerse the entire reaction pad of the Perassay strip in the solution n Shake off excess solution n Read 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. n Remove 1 ml of solution from the dialysate port of the dialyzer n Immerse the entire reaction pad of the Perassay strip in the solution n Shake off excess solution n Read 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 nTurn 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. nAllow a few drops of saline to drip from the venous line onto the residual test strip. nAfter 5 seconds, shake the excess liquid from the reaction zone and compare with the color scale on the container. nPer AAMI standards, a reading of less than 3 PPM is acceptable nTurn 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. nAllow a few drops of saline to drip from the venous line onto the residual test strip. nAfter 5 seconds, shake the excess liquid from the reaction zone and compare with the color scale on the container. nPer AAMI standards, a reading of less than 3 PPM is acceptable

86 Handling and Storage of Reprocessed Dialyzers n If a dialyzer is foaming after being reprocessed it should be reprocessed again without a use nStore a reprocessed dialyzer in a cool, well ventilated area that is shielded from any direct sunlight. Recommended temperature range is 59-75° F nA reprocessed dialyzer should not be used until a minimum of 11 hours has elapsed nAfter storage and before rinsing, both headers of the dialyzers must be at least 2/3 full n If a dialyzer is foaming after being reprocessed it should be reprocessed again without a use nStore a reprocessed dialyzer in a cool, well ventilated area that is shielded from any direct sunlight. Recommended temperature range is 59-75° F nA reprocessed dialyzer should not be used until a minimum of 11 hours has elapsed nAfter storage and before rinsing, both headers of the dialyzers must be at least 2/3 full

87 Renalin ® Spill n Flush spill with large quantities of water and also consult the handout “What to do if Renalin ® spills” n After hours, contact Chemtrec for emergency spill information at ( in the Washington D.C. area) n Flush spill with large quantities of water and also consult the handout “What to do if Renalin ® spills” n After hours, contact Chemtrec for emergency spill information at ( in the Washington D.C. area)

88 Questions


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