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Renatron® II Service Maintenance Seminar







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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 5:00 PM- End of first day. Class Schedule. DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break
Renatron® II Service Maintenance Seminar

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Slide 1

Renatron® II Service Maintenance Seminar

Slide 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

Slide 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

Slide 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.

Slide 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.

Slide 6

Specifications

Slide 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 100-120vac, one 4A

Fuses 220-240vac, two T2A

Slide 8

Environmental Limits

Operation Ambient Temperature Range

41-104° F (5-40° C)

Slide 9

Water Requirements

Water must be filtered to particle size no larger than 1 micron.

Inlet Water Must Meet or Exceed AAMI Guidelines

Slide 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)

Slide 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 30-35 PSI in Step 4.

Slide 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

Slide 13

Drain Requirements

Must be able to accept 6 liters (1.6 Gallons) per minute per Renatron®.

Slide 14

Materials of Construction

The drain should be constructed of PVC/CPVC or other Non-corrosiveMaterial

Slide 15

Renatron II Station Components

Slide 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

Slide 17

Renatron® II Station Components

  • Pressure gauge block/regulator

  • 70 cc cal cell

  • Drip tray-single or dual

  • Renalin®100 Uptake tube assembly

Slide 18

Renatron® II Station Components

  • Computer

  • Top of the line computer system

  • Windows XP

    Monitor

  • VGA Monitor- CRT or Flat Screen

Slide 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

Slide 20

Overview of Dialyzer Reprocessing

Slide 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

Slide 22

Dialyser Cleaning

Many clinics will clean or rinse a dialyzer before reprocessing.

Blood side flush

RUF

Renaclear®

Slide 23

Reprocessing

  • Attaching a dialyzer

    Connect:

    • Venous blood side

    • Venous dialysate side

    • Arterial dialysate side

    • Arterial blood side

Slide 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

Slide 25

Dialyzer Storage

Storage Area

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

Slide 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

Slide 27

RENATRON® II SYSTEMOPERATION

Slide 28

Power Up Sequence

Power on sequence

Printers

Monitor

Computer

Interface module

Renatron® II

All at once if using the power strip

Slide 29

Renalog® RM Start Up

  • Log in

  • 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

Slide 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

Slide 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.

Slide 32

Modes of Operation

Slide 33

Program Mode

Low flux dialyzers (00) kuf <8. Program time = 8 minutes.

High efficiency dialyzers (CH) kuf 8-15. Program time= 10 minutes.

High flux dialyzers (HF) kuf 15+. Program time = 10 minutes.

Slide 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.

Slide 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

Slide 36

Manual ReprocessingWith 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?

Slide 37

Manual Reprocessingwith 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

Slide 38

Preclean Mode

Slide 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.

Slide 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

Slide 41

User Authentication Label

Information Label

Barcode labels

Dialyzer Barcode Label

Pre-Cleaned Label

Calibration Cell Label

Failed Label

Slide 42

Sanitize Program

Slide 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.

Slide 44

Minimum Sanitize Time

  • The Renatron must sit for a minimum of 6 hours before it can be used.

Slide 45

Maximum Sanitize Time

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

Slide 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.

Slide 47

External Disinfection(Daily)

1 % Renalin® solution is used to wipe down external surfaces of the Renatron® station

Actril® undiluted is also acceptable

Slide 48

Formula 409 Cleaning

Slide 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

Slide 50

409® Cleaning

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

Slide 51

Dialyzer Reprocessing Cycle

Slide 52

Cleaning CycleStep 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

Slide 53

Test- Step 25 to 40Blood Compartment Volume MeasurementStep 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%

Slide 54

Test- Step 25 to 40Pressure 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

Slide 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

Slide 56

Interface Module/Scanner Operation

Slide 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.

Slide 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.

Slide 59

Renalog® RM Label Printer

Slide 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

  • Slide 61

    Renatron® II 100 Controls and Indicators

    Slide 62

    Description of Controls

    • On

    • Off

    • Hold to Set

      • Set Knob

    • Start Process

    • Start Sanitize

    • Mute

    • Reset

    • Display

    Slide 63

    Indicators

    • Volume Display

    • Program Step

    • Clean

    • Test

    • Disinfect

    • Process Complete

    • Sanitize Complete

    Slide 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

    Slide 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

    Slide 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

    Slide 67

    Technical Service

    Telephone Support

    24 hours a day 7 days a week

    1-800-328-3324

    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

    Slide 68

    Warranty / Promotions

    Warranty

    1 year warranty from date of install

    90 days for service warranty

    90 days for parts orders

    Promotions

    PM contracts

    Service contracts

    Slide 69

    Renalin® 100

    Slide 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.

    Slide 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).

    Slide 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.

    Slide 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

    Slide 74

    Renalin®100 Storage

    • Renalin®100 Storage

      • 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

    Slide 75

    Renalin® 100

    • 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.

    Slide 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

    Slide 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.

    Slide 78

    Renalin® Nomenclature

    • 4% Renalin® solution is used to sanitize the Renatron®

    • 2% Renalin® solution is used during the preclean program

    Slide 79

    Auto Dilutor

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

    Slide 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

    Slide 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.

    Slide 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

    Slide 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

    Slide 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.

    Slide 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

    Slide 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

    Slide 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

      800-424-9300 (202-483-7616 in the Washington D.C. area)

    Slide 88

    Questions


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