50090679.D RENALIN 100 DFU
Contents
1. CAUTION IF EXCESSIVE FOAMING AT BLOOD LINE DIALYZER CONNECTORIS APPARENT UPON COMPLETION OF REPROCESSING THE OPERATOR SHOULD REPROCESS THE DIALY ZER AGAIN THIS ACTION WILL REDUCE THE POSSIBILITY OF A LARGE DIALYZER PRESSURE BUILDUP IN STORAGE AND MAY IMPROVE VOLUME MEASUREMENT 1 Disconnect the dialyzer from the Renatron 100 reprocessing system Use caution when disconnecting the dialyzer to avoid being sprayed with proportioned Renalin 100 solution 2 Do not proceed with reuse of dialyzers where a volume of less than 80 of original priming volume is obtained High residual amounts of blood products organic load indicated by alow priming volume may reduce Renalin 100 concentrations bel ow an effective level 3 Place disinfected blood port caps and dialysate port caps on the dialyzer Refer to the Renatron 100 Instruction M anual for further details CAUTION DIALYZERS REPROCESSED WITH PROPORTIONED RENALIN 100 SOLUTION MAY UNDERGO AN INTERNAL PRESSURE BUILD UP DURING STORAGE THEREFORE ONLY USE RENAL SYSTEMS DIALYSATE PORT CAPS A VENTABLE DIALYZER DIALYSATE PORT CAP P N 78208 000 ALLOWS PERSONNEL TO VENT PRESSURE BUILD UP IN DIALYZERS PRIOR TO REMOVING PORT CAP 4 Storethe capped reprocessed dialyzer with both dialysate port caps resting against a shelf or other hard surface because internal pressure may rise sufficiently during storage to force the dial ysate port caps from the dialyzer If the dialyzer or2. 32 F 75 F 0 C 24 C 2 DO NOT FREEZE 3 DO NOT STORE IN DIRECT SUNLIGHT Shelf Life 1 Renalin 100 Cold Sterilant is stable for one year when stored accordi ng to label directions An expiration date is assigned at the time of manufacture 2 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 This deterioration has been considered while calculating the amount of Renalin 100 to be used with the Renatron 100 Dialyzer Reprocessing Systems 3 When diluting Renalin 100 Cold Sterilant to a 196 solution e g port cap disinfection fresh Renalin 100 Cold Sterilant should be used each time Do not allow 196 Renalin 100 solution to sit for longer than 24 hours WARNING DO NOT GET IN EYES ON SKIN OR ON CLOTHING USE UNIVERSAL PRECAUTIONS WEAR EYE PROTECTION RUBBER GLOVES AND PROTECTIVE CLOTHING WHEN HANDLING RENALIN 100 COLD STERILANT WASH THOROUGHLY AFTER HANDLING CAUTION PRIOR TO USE IN THE RENATRO N 100 RENALIN 100 COLD STERILANT MUST NOT BE DILUTED CAUTION ALWAYSSTORERENALIN 100COLDSTERILANT UPRIGHT ANDOUT OF DIRECT SUNLIGHT EXPOSURETOSUNLIGHT DAMAGES THE CLEANING AND DISINFECTING QUALITIES OF RENALIN 100 COLD STERILANT NOTE STORING RENALIN 100 COLD STERILANT IN ITS ORIGINAL SHIPPING CARTON PREVENTS EXPOSURES TO DIRECT SUNLIGHT NOTE THE RENALIN 100 COLD STERILANT CONTAINER IS TR
3. AAMI ANSI STANDARD QUALITY WATER IMMEDIATELY AFTER EACH TEST TO AVOID A FALSE INDICATION ON SUBSEQUENT TESTS WARNING A HOLLOW FIBER DIALYZER THAT IS REPROCESSED AND STERILIZED WITH RENALIN 100 COLD STERILANT BY THE RENATRON 100 REPROCESSING SYSTEM IS FILLED WITH PROPORTIONED RENALIN 100 SOLUTION HY DRO GEN PEROXIDE AND PEROXYACETIC ACID THE PROPORTIONED RENALIN 100 SOLUTION MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALY ZER PRIOR TO CLINICAL USE CAUTION DO NOT CONNECT DIALYSATE SUPPLY LINES TO DIALYZER PRIOR TO BLOOD COMPARTMENT RINSE OF PROPORTIONED RENALIN 100 SOLUTION TO DO SO WILL RESULT IN AIRGENERATION WITHIN THEDIALY ZERFIBERS FROM RENALIN 100 REACTION WITH WARM DIALYSATE EXCESS AIR MAKES IT DIFFICULT TO PRIME THE DIALYZER AND TO RINSE STERILANT FROM THE FIBERS l Placethe dialyzer in its holder on the dialysis machine with the arterial red end up Do not remove any of the port caps 2 Check to ensure that the dialysis machine is ready for normal operation including connections for electrical power water supply dialysate source and drain 3 Routethe arterial line on the dialysis machine Open the arterial red access end cap on the pati ent end of the blood line and position the open end over a container to collect saline overflow Do not connect the arterial blood lineto the dialyzer at this time Do not occlude the pump segment of the arterial blood linein the blood pump a
4. AAMI RECOMMENDED PRACTICES FOR REUSE OF HEMODIALYZERS STATESTHAT A REPROCESSEDDIALY ZERSHOULD BE USED ONLY BY A SINGLE PATIENT Renalin 100 Presence T est 1 After storage and before rinsing a Renalin 100 presence test should be performed to show that the dialyzer has been reprocessed with an effective concentration of proporti oned Renalin 100 solution 2 Check the dialyzer for proper labeling Labeling must include a Patient name b Number of previous uses reuse number c Date of last reprocessing WARNING PRESSURE WITHIN THE DIALYZER MAY CAUSE RENALIN 100SOLUTION TO SPRAY FROM THE PORT WHEN CAP IS REMOVED BE PREPAREDTO DIRECT THIS SPRAY INTO AN APPROPRIATE BASIN OR WASTE CONTAINER WHEN THE CAP IS REMOVED Renalin 100 Presence Test Prior to Dialyzer Rinse Instructions for Use Instructions for Use 3 To perform a Renalin 100 presence test using Perassay 500 T est Strips P N 78378 000 a Point dialysate port away from face Slowly remove one dialysate port cap b Remove approximately 1 ml of proportioned Renalin 100 solution from the dialysate compartment by squeezing remaining dialysate port cap and collecting 1cc of sample in clean vial c Dip the Perassay 500 Test Strip into the sample immersing the entire pad d Remove the test strip and gently shake off excess liquid e After two to five seconds note the reaction pad color development The test strip should turn a blue
5. DIALYZER THAT HAS BEEN REPROCESSED USING RENALIN 100 IS THE SOLE RESPONSIBILITY OF THE ATTENDING PHYSICIAN WARNING A HOLLOW FIBER DIALYZER THAT IS REPROCESSED AND STERILIZED WITH RENALIN 100 COLD STERILANT BY THE RENATRON 100 SERIES AND RENATRON II 100 SERIES DIALYZER REPROCESSING SYSTEM ISFILLEDWITH A PROPORTIONEDRENALIN 100 SOLUTION HYDROGEN PEROXIDE AND PEROXYACETIC ACID THE PROPORTIONED RENALIN 100 SOLUTION MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO CLINICAL USE CAUTION WHEN USING RENALIN 100 COLD STERILANT TO DISINFECT KIDNEY MACHINES FOLLOW KIDNEY MACHINE MANUFACTURER S DIRECTIONS Instructions for Use Warranty and Limitation of Damages Contents Instructions for Use MINNTECH WARRANTS TO CUSTOMER THAT MINNTECH POSSESSES GOODANDMARKETABLETITLETOTHEPRODUCT SOLD TO CUSTOMER AND THAT THE PRODUCTS ARE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP AT THE TIME OF SHIPMENT AND UNDER NORMAL USE FOR THE PERIOD OF TIME SPECIFIED ON THE PRODUCT S LABELING AND ii AREIN COMPLIANCE WITH THESPECIFICATIONSFOR THE PRODUCTS THE LIABILITY OF MINNTECH UNDER THIS LIMITED WARRANTY DOES NOT EXTEND TO ANY ABUSE OR MISUSE OF THE PRODUCTS ANY USE THAT 15 CONTRAINDICATED OR ANY USE THAT IS NOT IN ACCORDANCE WITH THE PRODUCT S LABELING WHICH SHALL VOID THIS WARRANTY IF THE PRODUCT DOES NOT MEET THIS LIMITED WARRANTY MINNTECH S SOLE OBLIGATION SHALL BE TO REPLACE THE PRODUCT AND THIS SH
6. EYES OR SKIN OR CAUSE IRRITATION TO MEMBRANES IN THE NOSE THROAT OR LUNGS f Renalin 100 Cold Sterilant contacts eyes immediately flush eyes with cool running water for fifteen minutes lifting upper and lower lids intermittentl y Remove contact lenses and conti nueto flush eyes thoroughly with water for fifteen minutes Promptl y seek medical attenti on n case of skin contact wash affected area with large amounts of water If irritation persists seek medical attention f breathing discomfort occurs immediately leave area and seek fresh air 1 Renalin 100 Cold Sterilant is corrosive and an oxidizer In case of a spill use Universal Precautions Wear eye protection rubber gloves and protective clothing when working with Renalin 100 Cold Sterilant Use eye protection that guards against splashing Gloves should be rubber kitchen variety strength Long sleeve clothing is recommended In the event that the permissible exposure limit PEL as measured by time weighted average TWA is exceeded 10ppm for acetic acid and 1 ppm for hydrogen peroxide suitable respiratory protection should be used WARNING DO NOT USE BLEACH OR AMMONIA TO MOP UP SPILLED RENALIN 100 COLD STERILANT After donning protective gear create a barrier around the spill and sprinkle powdered baking soda sodium bicarbonate or soda ash sodium carbonate on the spill to neutralize the solution a If a floor dr
7. RENALIN 100 SOLUTION AFTER STORAGE AND BEFORE RINSING DIALYZERS MUST BE FILLED WITH PROPORTIONED RENALIN 100 SOLUTION THE SIZEOF THEAIRBUBBLEIN THE HEADER SHOULD BE NOLARGER THAN ONE THIRD 1 3 THE TOTAL CROSS SECTIONAL AREA OF THE HEADER AFTER STORAGE AND BEFORE THE DIALYZER IS RINSED AND CLINICALLY USED A RENALIN 100 PRESENCE PERASSAY 500 TEST SHOULD BE PERFORMED AFTER RINSING THE DIALYZER AND IMMEDIATELY PRIOR TO CLINICAL USE A RENALIN 100 RESIDUAL TEST SHOULD BE PERFORMED RINSE KIDNEY MACHINE ACCORDING TO MANUFACTURER S INSTRUCTIONS FOLLOWING DISINFECTION STEPS USE AAMI QUALITY WATER FOR RINSING KIDNEY MACHINES AFTER DISINFECTING WITH RENALIN 100 SOLUTION RECONTAMINATION OF MACHINESIS POSSIBLEIF RINSEWATER DOES NOT MEET AAMI QUALITY STANDARDS WHEN USED WITH KIDNEY MACHINES DO NOT HEAT RENALIN 100 COLD STERILANT ABOVE 75 F 24 WHEN USED WITH KIDNEY MACHINES CHECK WITH MACHINE MANUFACTURER TO VERIFY COMPATIBILITY OF MATERIALS IF SPILLED FLUSH AWAY WITH LARGE QUANTITIES OF WATER SEE RENALIN 100 SPILL PROCEDURE IN THIS MANUAL IN CASE OF CONTACT WITH SKIN OR EYES IMMEDIATELY FLUSH Statement WITH LARGE AMOUNTS OF WATER FOR AT LEAST FIFTEEN 15 i MINUTES FOR EXPOSURE TO EYES REMOVE CONTACT LENSES of Practical AND CONTINUE TO FLUSH EYES THOROUGHLY WITH WATER Treatment FORAT LEAST FIFTEEN 15 MINUTES PROMPT MEDICAL ATTENTION IS NECESSARY IF SWALLOWED DRINK WATER IMMEDIATE
8. gray or blue black Thisis a positive result and indicates peracetic acid levels of 500 ppm mg L or greater f Any results other than bl ue gray or blue black is a negative result and indicates peracetic acid levels less than 500 ppm mg L Reprocessed dialyzers that test negati ve should be considered non sterile and not accepted 4 To perform a Renalin 100 presence test using Renalin Indicator Test Kit P N 78199 000 Test kit includes relative indicator test strips and a graduated dilution vial a Point dialysate port away from face Slowly remove one dialysate port cap b Remove 1cc of proportioned Renalin 100 solution from the dialysate compartment by squeezing remaining dialysate port cap and collecting 1cc of sample clean graduated dilution vial provided with test kit P N 78199 000 c Dilute the 1cc sample with AAMI quality water to the 8cc mark d vial and shake to mix solution e Remove the cap and dip a relative indicator test starch paper into the solution The test strip should promptly turn a dark blue or blue black This is a positive result for the presence of proportioned Renalin 100 solution f Any results other than dark blue or blue black is a negative result for the presence of proportioned Renalin 100 solution Reprocessed dial yzers that test negative should be considered non sterile and not accepted CAUTION THE GRADUATED TEST VIAL AND CAP MUST BE CAREFULLY RINSED WITH
9. 0 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 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 ALL PERSONNEL USING RENALIN 100 COLD STERILANT SHOULD BE FAMILIAR WITH THE INFORMATION CONTAINED IN THIS MANUAL WARNING IT IS THE RESPONSIBILITY OF THE PRESCRIBING PHYSICIAN TOENSURETHAT THEUSERS OF RENALIN 100 COLD STERILANT ARE PROPERLY TRAINED AND TECHNICALLY COMPETENT DANGER KEEP OUT OF REACH OF CHILDREN WARNING CORROSIVE CAN CAUSE EYE DAMAGE ANDSKIN IRRITATION DO NOT GET IN EYES ON SKIN OR ON CLOTHING USE UNIVERSAL PRECAUTIONS WEAR EYE PROTECTION RUBBER GLOVES AND PROTECTIVE CLOTHING WHEN HANDLING RENALIN 100 COLD STERILANT WASH THOROUGHLY AFTER HANDLING IN CASE OF EYE OR SKIN CONTACT IMMEDIATELY FLUSH WITH LARGE AMOUNTS OF WATER WARNING HARMFUL IF SWALLOWED IF SWALLOWED DRINK WATER IMMEDIATELY TO DILUTE DO NOT ATTEMPT TO INDUCE VOMITING CALL PHYSICIAN IMMEDIATELY NOTE TO PHYSICIAN PROBABLE MUCOSAL DAMAGE MAY CONTRAINDICATE GASTRIC LAVAGE WARNING DO NOT ALLOW RENALIN 100 COLD STERILANT TO MIX WITH ALKALINE SUBSTANCES SUCH AS BLEACH SODIUM HY POCHLORITE WAR
10. ALL BE CUSTOMER S EXCLUSIVE REMEDY UNDER NO CIRCUMSTANCES WILL MINNTECH BE LIABLE FOR ANY DIRECT ORINDIRECT INCIDENTAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE OF ANY KIND INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR ECONOMIC LOSS WHETHERSUCH CLAIM ISBASEDON WARRANTY CONTRACT TORT OR OTHERWISE THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHERWARRANTIES WHETHEREXPRESS ORIMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTY FOR SUITABILITY FITNESS FOR A PARTICULAR PURPOSE OR ABSENCE OF HIDDEN DEFECTS l INDICATIONS 3 Il CONTRAINDICATIONS eee nemen nennen 3 Ill WARNINGS AND PRECAUTIONS enne emen 3 IV STATEMENT OF PRACTICAL TREATMENT 5 Ve DESCRIPTION iter rere 6 Vike SPECIEICAT IONS inn 8 VII DILUTION AND INITIAL HANDING INSTRUCTIONS 8 Vill HANDLING AND STORAGE OF REPROCESSED DIALY ZERS 10 IX RENALIN 100 PRESENCE TEST PRIOR TO DIALYZER RINSE 11 X RECOMMENDED DIALY ZER RINSE PROCEDURE 13 XI RENALIN 100 RESIDUAL TEST FOLLOWING DIALYZER RINSE 16 XII RENALIN 100 SPILL PROCEDURE eee 17 Renalin 100 Cold Sterilant is indicated for the in vitro cleaning and sterilizing of hollow fiber dialyzers with the Renatron 100 Series and Renatron 100 Series Dialyzer Reprocessi ng System labeled for use with Renalin 10
11. ANSLUCENT AND IS PACKAGED IN A SHIPPING CARTON THE CONTAINER IS TRANSLUCENT TO ALLOW THE USER TO VIEW THE LEVEL OF SOLUTION Dilution for 196 Renalin 100 Solution NOTE TO ASSURE EFFICACY MAKE FRESH 196 RENALIN 100 SOLUTION DAILY DO NOT ALLOW 1 RENALIN 100 SOLUTION TO SIT OVERNIGHT FOR USE THE FOLLOWING DAY 1 To make 196 Renalin 100 Solution from Renalin 100 Cold Steril ant a Dilute one part Renalin 100 Cold Sterilant with 99 parts AAMI quality water To make the volume of 196 Renalin 100 solution by volume shown in column three dilute the volume of Renalin 100 Cold Sterilant by volume shown in column one with the volume of AAMI quality water shown in column two Renalin amp 100 AAMI Quality Water 1 Renalin amp 100 Cold Sterilant Solution 5mL 495 mL 500 mL 10 mL 990 mL 1000 mL 15 mL 1485 mL 1500 mL 20 mL 1980 mL 2000 mL 9 Instructions for Use Handling and Storage of Reprocessed Dialyzers Instructions for Use WARNING REPROCESSED DIALY ZERS SHOULD NOT BE CLINICALLY USED UNTIL A MINIMUM STORAGE TIME OF ELEVEN 11 HOURS HAS ELAPSED SINCE THE FINAL REPROCESSING CYCLE WARNING AFTER THE DIALYZER HAS BEEN REPROCESSED AND FILLED WITH RENALIN 100 COLD STERILANT ANY REMAINING BLOOD PRODUCTS IN THE DIALY ZER WILL REACT WITH THE RENALIN 100 AND CAUSE PRESSURE BUILD UP USE CARE AT ALL TIMESTOAVOIDBEINGSPRAY EDWITH THE RENALIN 100 SOLUTION
12. INSTRUCTIONS FOR USE renalinioo Cold Sterilant Concentrate For use with the Renatron 100 Series and Renatron 100 Series Dialyzer Reprocessing Systems RENALIN and RENATRON are registered trademarks of Minntech Corporation Printed and assembled in the United States All Rights Reserved am MINNTECH renal systems Disinfectants Sterilants Instructions for Use IT IS VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT IN MANNER INCONSISTENT WITH ITS LABELING A READ THIS MANUAL COMPLETELY PRIOR TO USING RENALIN 100 COLD STERILANT FAILURE TO FOLLOW INSTRUCTIONSIN THISMANUALMAY RESULT ININJURY RETAIN THIS MANUAL FOR FUTURE REFERENCE AN READ THE MACHINE INSTRUCTION MANUAL COMPLETELY PRIOR TO USING RENALIN 100 COLD STERILANT FOR DIALYZER REPROCESSING WITH THE RENATRON 100 SERIES AND RENATRON II 100 SERIES DIALYZER REPROCESSING SYSTEM A READ THE APPROPRIATE KIDNEY MACHINE INSTRUCTION MANUAL COMPLETELY PRIOR TO USING RENALIN 100 COLD STERILANT FOR KIDNEY MACHINE DISINFECTION CAUTION U S A FEDERAL LAW RESTRICTS THIS PRODUCT TO SALE BY OR ON ORDER OF A PHYSICIAN WARNING RENALIN 100 COLD STERILANT IS INTENDED FOR THE PURPOSE OF IN VITRO CLEANING AND STERILIZING OF HOLLOW FIBER DIALYZERS WITH THE RENATRON 100 SERIES AND RENATRON II 100 SERIES DIALYZER REPROCESSING SYSTEM WHICH IS LABELED FOR USE WITH RENALIN 100 ANY SUBSE QUENT CLINICAL APPLICATION OR USE OF A HOLLOW FIBER
13. LY TO DILUTE DO NOT ATTEMPT TO INDUCE VOMITING CALL PHYSICIAN IMMEDIATELY NOTE TO PHYSICIAN PROBABLE MUCOSAL DAMAGE MAY CONTRAINDICATE GASTRIC LAVAGE FOR CHEMICAL EMERGENCY SPILL LEAK FIRE EXPOSURE OR ACCIDENT CALL CHEMTREC 800 424 9300 IN DISTRICT OF COLUMBIA OR OUTSIDE CONTINENTAL U S A CALL 703 527 3887 5 Instructions for Use int General Product Application Description Renalin 100 Cold Sterilant is intended for dialyzer reprocessing with models RS8300 Renatron 100 Series Dialyzer Reprocessing System hereafter refered to as Renatron 100 and 858330 Renatron 100 Series Dial yzer Reprocessing System hereafter refered to as Renatron 100 labeled for use with Renalin 100 Renalin 100 Cold Sterilant maintains stability for one year when stored according to label directions Renalin 100 Cold Steril ant may be used for manual dialyzer reprocessing Facilities practicing manual dialyzer reprocessing must independently validate their reprocessing protocols to establish safety and effecti veness according to ANSI AAMI guidelines Contact Renal Systems for additional information Once properly diluted the active ingredients will begin to decay Renalin 100 Cold Sterilant offers the following advantages compared to traditional reprocessing chemicals 1 Renalin 100 is a single solution which replaces formal dehyde hydrogen peroxide and or bl each when used for dial yzer reprocessi ng 2 Post
14. NING OXIDIZER AVOID CONTACT WITH COMBUSTIBLE MATERIALS Indications Contraindications Warnings and Precautions Instructions for Use Instructions for Use CAUTION RENALIN 100 COLD STERILANT WILL UNDERGO RAPID DECOMPOSITION IF ALLOWED TO CONTACT METAL DUST ORGANIC MATERIALS ORIF IT IS DILUTED WITH WATERFAILING TO MEET ANSI AAMI STANDARDS STORERENALIN 100COLDSTERILANT UPRIGHT IN THEORIGINAL SHIPPING CARTON STORE RENALIN 100 COLD STERILANT IN ORIGINAL UNOPENED CONTAINER NEVERTAMPER WITH VENT CAP DO NOT STORE RENALIN 100 COLD STERILANT IN DIRECT SUNLIGHT MAINTAIN STORAGE TEMPERATURE BETWEEN 32 F 75 F 0 C 24 THE EXPIRATION DATE OF RENALIN 100 IS INDICATED ON THE CONTAINER LABEL THE EXPIRATION OF 1 RENALIN 100 SOLUTION IS 24HOURS FROM THETIME OF DILUTION FORANY OTHER APPLICATIONS THAT MAY REQUIRE DILUTION OF RENALIN 100 CONTACT YOUR MINNTECH REPRESENTATIVE FOR ADDITIONAL INFORMATION USE AAMI QUALITY WATER FOR DILUTION OF RENALIN 100 COLD STERILANT ALWAYS USE RENALIN 100 UPTAKE TUBE CHECK VALVE USE CARE WHEN DISCONNECTING THE DIALYZER FROM THE RENATRON 100 SYSTEM TO AVOID BEING SPRAYED WITH RENALIN 100 SOLUTION USE ONLY THOSE CAPS SPECIFIED FOR USE WITH RENALIN 100 AND OR RENALIN 100 COLD STERILANT TO CLOSE THE DIALYSATE PORTS AND BLOOD PORTS USE CARE WHEN REMOVING PORT CAPS FROM REPROCESSED DIA LY ZERS AFTER STORAGE TO AVOID BEING SPRAYED WITH PROPORTIONAL
15. ULD BE STORED AT ROOM TEMPERATURE KEEP CONTAINER TIGHTLY CAPPED WHEN NOT IN USE CHECK EXPIRATION DATE ON CONTAINERPRIORTO USE 7 Instructions for Use Specifications Manual Dilution and Initial Handling Instructions Instructions for Use Dialyzer Testing Testing of reprocessed dialyzers performs two functions 1 Renalin 100 presence test verifies the dialyzer is filled with an effective concentration of proportioned Renalin 100 solution 2 Renalin 100 residual test verifies the proportioned Renalin 100 solution has been properly removed rinsed from the dialyzer prior to clinical use patient connection Kidney Machines To disinfect kidney machines using Renalin 100 Cold Sterilant follow the kidney machine manufacturer s directions for use Active Ingredients Hydrogen peroxide and Peroxyacetic aci d Packaging Item Weight Individual shipping Approx carton 4 x 1 U S Gallon 30 Ibs Container Dilution Requirements 1 Water used for manual dilution must meet or exceed the ANSI AAMI standards for Hemodialysis Systems and ANSI AAMI Reuse of Hemodialyzers 2 Water used for manual dilution must be pre filtered through a 1 0 micron or smaller filter 3 Water used for manual dilution must be at a temperature betw een 59 F 75 F 15 C 24 C Environmental Limits l Maintain storage temperature of Renalin 100 Cold Sterilant and proportioned Renalin 100 solution between
16. access end cap Open the dialyzer connector on the arterial blood line and position the open end over a container to collect saline overflow Remove the clamp between the saline line and the blood pump segment Continue priming the arterial blood line by gravity until all air is purged Clamp the arterial blood line between the saline line and the open dialyzer end of the arterial blood line Remove the blood port cap from the arterial red end of the dialyzer and attach the arterial blood line Invert the dialyzer so that the venous end is up Open the dialyzer connector on the venous blood line Remove the blood port cap from the venous blue end of the dial yzer and attach the venous blood line Remove the clamp from between the salineline and the dialyzer end of the arterial line Thread the tubing pump segment through the blood pump and start the blood pump at 150 ml min When liquid reaches the venous drip chamber use the venous drip chamber leveling device or unclamp and open the venous monitor line to establish the fluid level at approximately 2 3 full Conti nue to pump saline through the lines and dialyzer until a minimum of 500 cc have drained out of the saline bag Stop the blood pump unless more saline is required to remove all air from the blood lines and dialyzer NOTE MOMENTARILY CLAMPING AND RELEASING THE VENOUS LINE DURING PRIMING WILL AID IN REMOVING ALL AIR FROM THE DIALY ZER 18 19 Clamp the venous bl
17. ain is available the spill area flush the area of the spill thoroughly with water After the spill area is clear of Renalin 100 Cold Sterilant continue to flush the drain with water for four to five minutes to clear the line b If the spill is large enough that it must be mopped it is essential that the spilled Renalin 100 first be neutralized with baki ng soda or soda ash If this procedure is not followed the unneutralized Renalin 100 will damage the mop Do not mix the neutralizing agent with Renalin 100 in a closed or unvented container This combination will produce a gas that results in high pressures What to do if Renalin 100 Cold Sterilant Spills Instructions for Use c To neutralize sprinkle enough powder to cover the spill thoroughly and wait a few minutes Using a very wet mop carefully mop up the neutralized Renalin 100 solution rinsing the mop frequently When complete flush the neutralized Renalin 100 solution to drain diluting approximately 1 1 with water Rinse the mop thoroughly and dry Wash down the area of spills with detergent and air dry d Place all Renalin 100 soaked cardboard packaging material s in a deep sink and thoroughly soak with cold water After soaki ng in cold water discard packaging materials in unsealed clean plastic trash bags 3 Renalin 100 contains hydrogen peroxide and peroxyacetic acid Safety precautions routinely used for disposal of these compounds should b
18. e observed 4 Immerse any clothing contaminated with Renalin 100 solution in water and wash as soon as possible 5 For additional information contact Renal Systems at 1 800 328 3340 Renal Systems Part Number Reference Chart Item Renal Systems Part Number Dialyzer Blood Port Caps 78197 000 Dialyzer Dialysate Port Caps 78196 000 SO Fitting Dialyzer Blood Port Caps 78397 704 Ventable Dialzyer Dialysis Port Caps 78208 000 Labels for Use with Renalog II 40080 025 Perassay 500 Directions for Use 50086 025 Perassay 500 Peracetic Acid Test Strips 78378 000 Renalin amp 100 Cold Sterilant without kit 78397 844 Renalin amp 100 Cold Sterilant 1 test kit 78397 845 Renalin amp 100 Cold Sterilant 3 test kits 78397 846 Renalin amp 100 Cold Sterilant Instructions for Use 50090 679 Renalin Indicator Test Strips 78199 000 Renalin amp Residual Test Strips 78198 000 Renalin amp Residual Test Strips Directions for Use 50083 000 Renalog Dialyzer Reprocessing Data Management System RS 8351 Reantron Service Manual 50101 000 RS 8351 Renalog Instruction Manual 50084 000 Reprocessing Connectors 100X 78397 699 R eferen ces 13 AAMI Association for the Advancement of Medical Instrumentation 1996 AAMI Standards and Recommended Practices Dialysis Vol 3 Arlington AAMI Reuse of hemodial yzers p 99 2 AAMI Association for the Advancement of M
19. edical Instrumentation 1996 AAMI Standards and Recommended Practices Dialysis Vol 3 Arlington AAMI Hemodialysis systems p 37 Instructions for Use 18
20. filtration control On dialysis machines having UF control set the fluid removal rate at 2 liters hr Recirculate for a minimum of ten 10 minutes 28 Check that the saline bag is not empty that the saline lineis not clamped and that salineis flowing from the bag to the blood lines salineis drippingthrough the bulb in the administrati on line 29 After recirculating at a negative pressure of 300 mmHg or UF rate of 2 liter hr for ten minutes adjust the UF rate to near zero maintaining slight negative pressure CAUTION RECIRCULATION AND A SLIGHT NEGATIVE PRESSURE SHOULD BE MAINTAINED IF SIGNIFICANT TIME ELAPSES BETWEEN RINSINGTHE DIALY ZERAND PATIENT CONNECTION THIS PROCESS WILL PREVENT REBOUND OF THE CHEMICAL STERILANT 15 Instructions for Use Renalin 100 Residual Test Following Dialyzer Rinse Instructions for Use After the completion of the rinse procedure on the dialyzer a test should be performed to determine the level of residual proportioned Renalin 100 solution present Proceed with residual testing as outlined below To perform resi dual test use Renalin Residual Test Strips P N 78198 000 l Turn off the blood pump and clamp both the arterial and venous blood lines adjacent to the access patient ends Separate the blood lines at the point where the access ends are joined Unclamp the venous blood line 2 Remove atest strip from the tube and immediately replace the lid 3 Allow afew dr
21. lons 3 liters in a 1 U S liquid gallon 3 78 liter container 3 Package contains four 4 containers 4 Each container has a vented cap to prevent excessive pressure build up during shipping and storage CAUTION NEVER CHANGE VENT CAPS OR TAMPER WITH ANY PART OF THE VENT CAP Perassay 500 Peracetic Acid Test Strips P N 78378 000 consists of 1 Peracetic acid test strips 2 Package insert Renalin Indicator Test Kit P N 78199 000 consists of 1 Relative indicator test strips 2 Graduated dilution vial Renalin Residual Test Strips P N 78198 000 consist of 1 Residual test strips 2 Package insert 3 Quantitative color chart for interpreting test results Renal Systems Test Strip Reference Chart Long Term Storage Conditions Test Stip P N Use Unopened Opened A F 104 F Room temperature Concentration test 3 Do not refrigerate C 40 C following reprocessing Tightly reclose vial when not in use Perassay 500 78378 000 41 104 Room temperature Renalin Indicator 78199 000 Concentration test 5 C 40 Do not refrigerate following reprocessing Tightly reclose vial when not in use 41 F 86 F Room temperature n Residual test following Do not refrigerate Renalin Residual 78198 000 dialyzer rinsing 5 C 30 C Tightly reclose vial when not in use NOTE RENALIN RESIDUAL TEST STRIPS SHO
22. ood line adjacent to its access patient end Remove the arterial blood line from the arterial red access end cap and insert the end of the arterial blood lineinto the open venous blue access end cap 20 Check that the dialysate has the correct conductivity and is at the proper temperature CAUTION USE ONLY DIALYSATE WITH PROPER CONDUCTIVITY FOR DIALY ZER PRIMING TO ENSURE PATIENT SAFETY 21 Invert the dialyzer so that the arterial red end is up 22 Remove the cap from the arterial dialysate port Attach the dialysate exit line to the arterial red end of the dial yzer 23 Remove the cap from the venous dialysate port Attach the dialysate supply to the venous blue end of the dial yzer CAUTION CONNECTING THE DIALYSATE SUPPLY LINE TO THE DIALY ZER PRIOR TO FLUSHING APPROXIMATELY 500 ML OF SALINE THROUGH THE DIALY ZER MAY CAUSEAN AIRLOCKIN THE DIALY ZER FIBERS 24 Set the ultrafiltration rate dialysate pressure at approximately 20 mmHg 25 Allow the dialysate to fill the dialyzer from bottom to top Attempt to remove all air from the dial ysate compartment while itis filling 26 Remove the clamps adjacent to the access patient ends on the arterial and venous blood lines Leave all monitor saline and heparin lines connected or clamped 27 Turn on the blood pump at a flow rate of approximately 300ml min Set the dialysate pressure to approximately 300mmHg on dialysis machines without ultra
23. ops of salineto drip from the venous blood line onto a residual test strip Do not allow the saline to flow through or over the open access end cap s top or any other object prior to contacting the stri p NOTE SQUEEZINGTHE VENOUS DRIP BULB WILLAIDIN OBTAINING A RESIDUAL SAMPLE 4 Allow droplets of solution to remain on the reaction zone for five seconds 5 Gently shake excess liquid and compare the reaction zone with the color scale 6 If the strip indicates less than ppm the dialyzer is safe for pati ent use 7 Iftheresultis ppm or greater reconnect the arterial and venous blood lines and continue rinsing the dialyzer Repeat the residual test procedure until result indicate the dialyzer has been adequately rinsed CAUTION IF STRIP INDICATES DARK BLUE TO BROWN OR GREEN TO BROWN THE CONCENTRATIONSARE TOO HIGH FORTHE COLOR SCALE AND FURTHER RINSING OF THE DIALYZER IS NEEDED 8 Reconnect the arterial and venous lines Remove the clamp adjacent to the access end on the arterial line and continue to recirculate until the patient is ready to be connected to the dialysis machine Continued recirculation will prevent rebound of the chemical sterilant If Renalin 100 Cold Sterilant spills or arrives in a damaged container be aware of the following precautions and procedures for disposal A Read warnings and precautions printed on bottles and cases WARNING RENALIN 100 COLD STERILANT CAN CAUSE PERMANENT INJURY TO
24. storage pre rinse Renalin 100 concentration tests are conducted quickly and easily 3 Post rinse pre treatment Renalin 100 residual tests are conducted quickly and easily 4 Renalin 100 byproducts degrade quickly and do not harm the environment These byproducts are oxygen water and an acetic acid mixture by products are natural and when properly diluted safe to flush into a sanitary sewer system Nomenclature For the purpose of clarity the following nomenclature will be used throughout this manual 1 AAMI QUALITY WATER is water which meets or exceeds the following requirements a AAMI ANSI Standard for Hemodialysis Systems and b Pre filtration through a 1 0 micron or smaller filter 2 RENALIN 100 COLD STERILANT is the concentrated solution manufactured by Renal Systems for use with Dialyzer Reprocessi ng Systems or for other uses in environments administering dialysis care 3 PROPORTIONED RENALIN 100 SOLUTION is the final solution proportioned by the Renatron 100 reprocessi ng system used in cleaning and sterilizing the reprocessed dial yzer 4 1 RENALIN 100 SOLUTION isa solution by volume resulting from the user s addition of AAMI quality water also known as a 100x dilution Instructions for Use 6 Renalin 100 Cold Sterilant consists of l A stabilized mixture of hydrogen peroxide peroxyacetic acid and acetic acid 2 Themixture is supplied with a 0 79 U S liquid gal
25. t this ti me 4 Clamp all monitor and heparin lines This may be accomplished by connecting each line to its appropriate connector on the dialysis machine 5 Connectthe saline administration priming set to the salineline on the blood tubing set 6 Clamp the arterial blood line at a point between the saline line and the blood pump segment For blood tubing sets which have the saline lineincorporated into the pump segment inlet either clamp the pump segment or the blood line at the outlet of the pump segment 7 Routethe venous blood line on the dialysis machine Open the venous blue access end cap on the patient end of the blood line and position the open end over a container to collect saline overflow Do not connect the venous blood to the dial yzer at this time Recommended Diaylzer Rinse Procedure Instructions for Use Instructions for Use 8 10 11 12 13 14 15 16 17 Clamp all venous monitor lines This be accomplished by connecting each lineto its appropriate connector on the dialysis machine Open the roller clamp on the saline administration set and prime the pre pump portion of the arterial line by gravity Check to make certain that all air is purged from the portion of the arterial line between the saline and the arterial red access end of the blood line Clamp the arterial blood line adjacent to its access patient end and close the arterial red
26. the confi gurati on of available storage space precludes storing as prescribed place the dialyzer in a polyethylene plastic bag or similar container to prevent possible inadvertent spraying of personnel and equipment Note that the inadvertent disconnection of dialysate port caps dueto high internal pressure indicates either one of two improper conditi ons the storage conditions are inadequate or the dialyzer is not fully clean 5 Store reprocessed dialyzers in a cool well ventilated area that is shielded from direct sunlight Recommended storage temperature range is 59 F 75 F 15 24 CAUTION EXPOSING DIALYZERS TO CYCLIC TEMPERATURE DIFFERENCES DURING ANY PART OF THE REUSE PROCEDURE MAY RESULT IN INCREASING OR INITIATING PRESSURE BUILD UP IN THE DIALY ZER DURING STORAGE WARNING REPROCESSED DIALY ZERS SHOULD NOT BE CLINICALLY USED UNTIL A MINIMUM STORAGE TIME OF ELEVEN HOURS HAS ELAPSED SINCE THE FINAL REPROCESSING CYCLE CAUTION AFTER STORAGE AND BEFORE RINSING DIALY ZERS MUST BE FILLED WITH PROPORTIONED RENALIN 100 SOLUTION THE SIZE OF THE AIR BUBBLE IN THE HEADER SHOULD BE NO LARGER THAN ONE THIRD 1 3 THE TOTAL CROSS SECTIONAL AREA OF THE HEADER IF LEAKAGE HAS OCCURRED IT IS RECOMMENDED THAT A SUBSEQUENT REPROCESSING CYCLE BE PERFORMED ON THE DIALYZER CAUTION AFTERSTORAGE AND BEFORE THE DIALY ZER IS RINSED ANDCLINICALLY USED RENALIN 100PRESENCETEST SHOULDBE PERFORMED CAUTION ANSI
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