Renatron® II Service Maintenance SeminarRenatron® II Service Maintenance Seminar

Class ScheduleClass 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

Class ScheduleClass 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

CautionsCautions 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.

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.

IndicationsIndications

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.

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.

SpecificationsSpecifications

Electrical Leakage CurrentElectrical 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

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

Environmental LimitsEnvironmental Limits

Operation Ambient Temperature Range

41-104° F (5-40° C)

Operation Ambient Temperature Range

41-104° F (5-40° C)

Water RequirementsWater Requirements

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

Inlet Water Must Meet or Exceed AAMI Guidelines

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

Inlet Water Must Meet or Exceed AAMI Guidelines

Water TemperatureWater 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)

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)

Feed Line FlowFeed 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.

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.

Peak Flow RatePeak Flow Rate

6 liters (1.6 gallons) per minute

15-35 seconds in duration

Occurs at approximately 3 minute intervals

3 times per cycle

6 liters (1.6 gallons) per minute

15-35 seconds in duration

Occurs at approximately 3 minute intervals

3 times per cycle

Drain RequirementsDrain Requirements

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

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

Materials of ConstructionMaterials of Construction

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

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

Renatron II Station Components

Renatron II Station Components

Renatron® II Station Components

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

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

Renatron® II Station Components

Renatron® II Station Components

Pressure gauge block/regulator 70 cc cal cell

Drip tray-single or dual Renalin®100 Uptake tube assembly

Pressure gauge block/regulator 70 cc cal cell

Drip tray-single or dual Renalin®100 Uptake tube assembly

Renatron® II Station Components

Renatron® II Station Components

Computer Top of the line computer systemWindows XP

Monitor VGA Monitor- CRT or Flat Screen

Computer Top of the line computer systemWindows XP

Monitor VGA Monitor- CRT or Flat Screen

Renatron® II Station Components

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

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

Overview of Dialyzer Reprocessing

Overview of Dialyzer Reprocessing

End of TreatmentEnd 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 physician The suggested maximum time interval is two hours

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

Dialyser CleaningDialyser CleaningMany clinics will clean or rinse a dialyzer before reprocessing.

Blood side flushRUF Renaclear®

Many clinics will clean or rinse a dialyzer before reprocessing.

Blood side flushRUF Renaclear®

Reprocessing Reprocessing

Attaching a dialyzer

Connect:Venous blood sideVenous dialysate sideArterial dialysate sideArterial blood side

Attaching a dialyzer

Connect:Venous blood sideVenous dialysate sideArterial dialysate sideArterial blood side

End of Reprocessing CycleEnd 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

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

Dialyzer StorageDialyzer 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

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

Dialyzer Testing before Treatment

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

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

RENATRON® II SYSTEM

OPERATION

RENATRON® II SYSTEM

OPERATION

Power Up SequencePower Up Sequence Power on sequence

Printers Monitor Computer Interface module Renatron® II

All at once if using the power strip

Power on sequence Printers Monitor Computer Interface module Renatron® II

All at once if using the power strip

Renalog® RM Start UpRenalog® 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

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

Renatron® II 100 StartupRenatron® II 100 Startup

Renalog® RM StartupRenalin® 100 is connectedThe Renatron® II 100 is sanitizedThe Renatron® II 100 is calibratedStatic and dynamic water pressure readings

Renalog® RM StartupRenalin® 100 is connectedThe Renatron® II 100 is sanitizedThe Renatron® II 100 is calibratedStatic and dynamic water pressure readings

Renatron® II 100 StartupRenatron® 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.

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.

Modes of OperationModes of Operation

Program ModeProgram 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.

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.

Automatic ReprocessingAutomatic 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.

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.

Semi-AutomaticSemi-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

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

Manual ReprocessingWith Computer

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 computerPreprocessReprocess without useReprocess after useRenatron numberContainer numberCurrent VolumeDid the dialyzer fail?

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 computerPreprocessReprocess without useReprocess after useRenatron numberContainer numberCurrent VolumeDid the dialyzer fail?

Manual Reprocessingwith Renatron® II 100 only

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

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

Preclean ModePreclean Mode

Pre-clean ModePre-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.

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.

CautionCaution

Pressure buildup may occur in dialyzers left on the Renatron®

Take care when removing the dialyzer Pressure buildup may cause fluid to

spray

Pressure buildup may occur in dialyzers left on the Renatron®

Take care when removing the dialyzer Pressure buildup may cause fluid to

spray

Barcode labelsBarcode labels

Dialyzer Barcode LabelDialyzer Barcode Label

Information LabelInformation LabelUser Authentication LabelUser Authentication Label

Pre-Cleaned LabelPre-Cleaned Label

Calibration Cell LabelCalibration Cell Label Failed Label

Sanitize ProgramSanitize Program

Daily SanitizeDaily 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.

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.

Minimum Sanitize TimeMinimum Sanitize Time

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

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

Maximum Sanitize TimeMaximum Sanitize Time

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

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

10 Minute Sanitize Cycle10 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.

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.

External Disinfection(Daily)

External Disinfection(Daily)

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

Actril® undiluted is also acceptable

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

Actril® undiluted is also acceptable

Formula 409 CleaningFormula 409 Cleaning

409® Cleaning 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

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

409® Cleaning 409® Cleaning

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

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

Dialyzer Reprocessing CycleDialyzer Reprocessing Cycle

Cleaning CycleStep 8 to 24

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

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

Test- Step 25 to 40Blood Compartment Volume Measurement

Step 25 to 35

Test- Step 25 to 40Blood Compartment Volume Measurement

Step 25 to 35 Fill Blood Compartment from venous to arterial- Step 25 Sweep Blood Compartment- Steps 29, 31 and 33Measure Mass- Step 35

Repeatability ± 5%

Fill Blood Compartment from venous to arterial- Step 25 Sweep Blood Compartment- Steps 29, 31 and 33Measure Mass- Step 35

Repeatability ± 5%

Test- Step 25 to 40Pressure Leak Test- Steps 36 to 39

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

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

Disinfect- Steps 41 to 57Disinfect- Steps 41 to 57

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

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

Interface Module/Scanner Operation

Interface Module/Scanner Operation

Interface ModuleInterface 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.

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.

ScannerScanner 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.

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.

Renalog® RM Label PrinterRenalog® RM Label Printer

Label PrinterLabel 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” label

Red light means that: Cover is not completely closed Ribbon is not advancing Labels are not advancing

Renatron® II 100 Controls and Indicators

Renatron® II 100 Controls and Indicators

Description of ControlsDescription of Controls On Off Hold to Set

Set Knob

Start Process Start Sanitize Mute Reset Display

On Off Hold to Set

Set Knob

Start Process Start Sanitize Mute Reset Display

IndicatorsIndicators Volume Display Program Step Clean Test Disinfect Process Complete Sanitize Complete

Volume Display Program Step Clean Test Disinfect Process Complete Sanitize Complete

Error MessagesError 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

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

Safety FeaturesSafety 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

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

Renatron® StorageRenatron® Storage

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

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

Technical ServiceTechnical Service

Telephone Support

24 hours a day 7 days a week 1-800-328-3324Press “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

Telephone Support

24 hours a day 7 days a week 1-800-328-3324Press “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

Warranty / PromotionsWarranty / Promotions Warranty

1 year warranty from date of install 90 days for service warranty 90 days for parts orders

Promotions PM contracts Service contracts

Warranty 1 year warranty from date of install 90 days for service warranty 90 days for parts orders

Promotions PM contracts Service contracts

Renalin® 100Renalin® 100

WarningsWarnings 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.

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.

IndicationsIndicationsRenalin® 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).

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).

ContraindicationsContraindications

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.

Water RequirementsWater 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

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

Renalin®100 StorageRenalin®100 Storage

Renalin®100 StorageUprightNever in direct sunlightAt temperatures between 32-75° FDo 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

Renalin®100 StorageUprightNever in direct sunlightAt temperatures between 32-75° FDo 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

Renalin® 100Renalin® 100 Renalin® 100 replaces

FormaldehydeBleach and/or hydrogen peroxide

Active ingredientsHydrogen peroxidePeroxyacetic acid Acetic acid

Renalin® 100 degrades quickly and will not harm the environment. It breaks down into ; oxygen, water, and acetic acid.

Renalin® 100 replacesFormaldehydeBleach and/or hydrogen peroxide

Active ingredientsHydrogen peroxidePeroxyacetic acid Acetic acid

Renalin® 100 degrades quickly and will not harm the environment. It breaks down into ; oxygen, water, and acetic acid.

Renalin 100®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

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

Renalin® NomenclatureRenalin® 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.

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.

Renalin® NomenclatureRenalin® Nomenclature

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

2% Renalin® solution is used during the preclean program

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

2% Renalin® solution is used during the preclean program

Auto DilutorAuto

Dilutor

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

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

Shelf LifeShelf 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

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

Shelf LifeShelf 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.

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.

Test StripsTest Strips Perassay Test Strip

Simple go/no go testIndicates a 1% Renalin® solutionGreen stick for identificationDo not need to be refrigerated

Perassay Test StripSimple go/no go testIndicates a 1% Renalin® solutionGreen stick for identificationDo not need to be refrigerated

Test StripsTest 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

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

Renalin® 100 Presence Test(Perassay)

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.

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.

Renalin® 100 Residual Test Strips

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

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

Handling and Storage of Reprocessed Dialyzers

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

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

Renalin® SpillRenalin® 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)

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)

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