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Renatron® II Service Maintenance Seminar

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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

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

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

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

8 Operation Ambient Temperature Range 41-104° F (5-40° C)
Environmental Limits Operation Ambient Temperature Range 41-104° F (5-40° C)

9 Water Requirements Water 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 static Minimum 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 duration Occurs at approximately 3 minute intervals 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
Renatron® II Dialyzer Reprocessing Station Has 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/regulator 70 cc cal cell Drip tray-single or dual Renalin®100 Uptake tube assembly

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

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

20 Overview of Dialyzer Reprocessing

21 End of Treatment After 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 physician The suggested maximum time interval is two hours

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

23 Reprocessing Attaching a dialyzer Connect: Venous blood side
Venous dialysate side Arterial dialysate side Arterial 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°F Out of direct Sun light Dialyzer Storage Minimum storage time is 11 hours Maximum 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 Strip The 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 Recirculate until treatment is started to prevent rebound


28 Power Up Sequence Power on sequence
Printers Monitor Computer Interface module Renatron® II All 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 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 Renalog® RM Startup Renalin® 100 is connected
The Renatron® II 100 is sanitized The Renatron® II 100 is calibrated Static and dynamic water pressure readings

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

32 Modes of Operation

33 Program Mode Low 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 Volume Program Mode When 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 dialyzer Select type of reprocessing Preclean Reprocess without a use Reprocess after use Sets the Renatron® II 100 to the proper settings for that dialyzer

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

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

38 Preclean Mode

39 Pre-clean Mode Pre-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 dialyzer Pressure buildup may cause fluid to spray

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

42 Sanitize Program

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 pressed The 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 Time The 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 Press 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® station Actril® undiluted is also acceptable

48 Formula 409 Cleaning

49 409® Cleaning Institutional Formula 409®
Institutional Formula 409® Cleaner Degreaser only Must say NQF Do not use any other solutions Internal 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® Cleaning Institutional Formula 409® is free when Renalin® 100 is ordered in proper quantities

51 Dialyzer Reprocessing Cycle

52 Cleaning Cycle Step 8 to 24 Chemical Draw- Step 9
Flush Blood Circuit Arterial to Venous-Step 14 Reverse Ultrafiltration- Steps 16 and 18 Flush Dialysate Compartment- Step 20 Flush Blood Circuit (Arterial to Venous)-Step 21 Flush 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 25 Sweep Blood Compartment- Steps 29, 31 and 33 Measure Mass- Step 35 Repeatability ± 5%

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

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

56 Interface Module/Scanner Operation

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 Scanner For 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.

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
Off Hold to Set Set Knob Start Process Start Sanitize Mute Reset Display

63 Indicators Volume Display Program Step Clean Test Disinfect
Process Complete Sanitize Complete

64 Error Messages Volume Fail- Step 35 Pressure Fail- Steps 36, 38, or 39
Add Chemical- Steps 9, 45, 67, or 77 Tank Volume- Many steps throughout the program Alarm Interlock

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

66 Renatron® Storage Long term storage
run machine through step 97 to ensure fluid pathways are drained Box in Renatron® box Keep 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 person Service Loaners available upon request Board exchanges for $200 RMA’s must accompany all returns

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

69 Renalin® 100

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 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.

73 Water Requirements AAMI quality water filtered to particle size no larger than 1 micron Water temperature should be between 59-75° F Water 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
Upright Never in direct sunlight At temperatures between 32-75° F Do not freeze Never tamper with the cap Never replace the vented cap with a nonvented cap Renalin® 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 peroxide Active ingredients Hydrogen peroxide Peroxyacetic acid Acetic acid Renalin® 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 bottles 2.5 gallon bottles that contain 2 liters of Renalin® concentrate 1 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 Dilutor The On Demand™ Auto Dilution System proportions Renalin® 100 Cold Sterilant and dispenses a continuous supply of 1% Renalin solution.

80 Shelf Life Renalin® 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 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 Perassay Test Strip Simple go/no go test
Indicates a 1% Renalin® solution Green stick for identification Do not need to be refrigerated

83 Test Strips Residual Test Strip
Color chart for interpreting test results Do not need to be refrigerated Verifies 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 dialyzer Immerse the entire reaction pad of the Perassay strip in the solution Shake off excess solution 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
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 use Store a reprocessed dialyzer in a cool, well ventilated area that is shielded from any direct sunlight. Recommended temperature range is 59-75° F A reprocessed dialyzer should not be used until a minimum of 11 hours has elapsed After storage and before rinsing, both headers of the dialyzers must be at least 2/3 full

87 Renalin® Spill Flush 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)

88 Questions

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