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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