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Cold Sterilant Concentrate INSTRUCTIONS FOR USE

1. 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 DIALYZERS 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 REPRO CESSED AND FILLED WITH RENALIN 100 COLD STE RILANT ANY REMAINING BLOOD PRODUCTS IN THE DIALYZER WILL REACT WITH THE RENALIN 100 AND CAUSE PRESSURE BUILD UP USE CARE AT ALL TIMES TO AVOID BEING SPRAYED WITH THE RENALIN 100 SOLUTION CAUTION IF EXCESSIVE FOAMING AT BLOOD LINE DIALYZER CONNECTOR IS APPARENT UPON COMPLETION OF REPROCESSING THE OPERATOR SHOULD REPROCESS THE DIALYZER 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 a low priming volume may reduce Renalin 100 concentrations below an effective level 3 Place disinfected blood port caps and dialysate port caps on the dialyzer
2. 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 Reprocessing Systems or for other uses in environments administering dialysis care 3 PROPORTIONED RENALIN 100 SOLUTION is the final solution proportioned by the Renatron 100 reprocessing system used in cleaning and sterilizing the reprocessed dialyzer 4 1 RENALIN 100 SOLUTION is a 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 1 A stabilized mixture of hydrogen peroxide peroxyacetic acid and acetic acid 2 The mixture is supplied with a Ten 10 liters in a 10 liter container b Four 4 test kits Package contains two 2 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 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
3. Refer to the Renatron 100 Instruction Manual 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 VENTABLE DIALYZER DIALYSATE PORT CAP P N 78208 000 ALLOWS PERSONNEL TO VENT PRESSURE BUILD UP IN DIALYZERS PRIOR TO REMOVING PORT CAP 4 Store the 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 dialysate port caps from the dialyzer If the dialyzer or the configuration 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 due to high internal pressure indicates either one of two improper conditions the storage conditions are inadequate or the dialyzer is not fully clean e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 5 Store reprocessed dialyzers in cool well ventilated area that is shielded from direct sunlight Recommended storage temperature range is 59 F 75 F 15 C 24 C CAUTION EXPOSING DIALYZERS TO CYCLIC TEMPERATURE D
4. Use 2 Renalin 100 Cold Sterilant is indicated for the in vitro cleaning and Indications sterilizing of hollow fiber dialyzers with the Renatron PA 100 Series and Renatron II 100 Series 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 15 not designed sold or intended use Contraindications 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 N ALL PERSONNEL USING RENALIN 100 COLD STERILANT Warnings and SHOULD BE FAMILIAR WITH THE INFORMATION CONTAINED IN Precautions THIS MANUAL WARNING IT IS THE RESPONSIBILITY OF THE PRESCRI BING PHYSICIAN TO ENSURE THAT THE USERS OF RE NALIN 100 COLD STERILANT ARE PROPERLY TRAINED AND TECHNICALLY COMPETENT DANGER KEEP OUT OF REACH OF CHILDREN WARNING CORROSIVE CAN CAUSE EYE DAMAGE AND SKIN IRRITATION DO NOT GET IN EYES ON SKIN OR ON CLOTHING USE UNIVERSAL PRECAUTIONS WEAR EYE PROTECTION RUBBER GLOVES AND PRO TECTIVE CLOTHING WHEN HANDLING RENALIN 100 COLD STERILANT WASH THOROUGHLY AFTER HAND LING IN CASE OF EYE OR SKIN CONTACT IMMEDIATELY FLUSH WITH LARGE AMOUNTS OF WATER WARNING HARMFUL IF SWALLOWED IF SWALLO WED DRINK WAT
5. the open access end top or any other object prior to contacting the strip NOTE SQUEEZING THE VENOUS DRIP BULB WILL AIDIN 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 Ifthe strip indicates less than 3 ppm the dialyzer is safe for patient use 7 Ifthe result is 3 ppm or greater re connect 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 TOBROWN THE CONCENTRATIONS ARE TOO HIGH FOR THE 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 CAUTION DISCARD THE RINSE SALINE BAG AND FLUSH THE SALINE ADMINISTRATION SET WITH A FRESH BAG BEFORE INITIATING DIALYSIS CAUTION DO NOT INFUSE RECIRCULATED SALINE PRIME INTO THE PATIENT AS A VOLUME ENHANCER 9 9 6 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 If Renalin 100 C
6. 090 720 C 2008 Minntech Corporation
7. ANCE WITH THE PRODUCT S LABELING WHICH SHALL VOID THIS WARRANTY IF THE PRODUCT DOES NOT MEET THIS LIMITED WARRANTY MINNTECH S SOLE OBLIGATION SHALL TO REPLACE THE PRODUCT AND THIS SHALL BE CUSTOMER S EXCLUSIVE REMEDY UNDER NO CIRCUMSTANCES WILL MINNTECH BE LIABLE FOR ANY DIRECT OR INDIRECT INCIDENTALORCONSEQUENTIALLOSS DAMAGE OREXPENSE OF ANY KIND INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR ECONOMIC LOSS WHETHER SUCH CLAIM IS BASED ON WARRANTY CONTRACT TORT OR OTHERWISE THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTY FOR SUITABILITY FITNESS FOR A PARTICULAR PURPOSE OR ABSENCE OF HIDDEN DEFECTS Contents EE ON o NR 3 9670 88888 880 3 WARNINGS AND PRECAUTIONS nn 3 IV STATEMENT OF PRACTICAL TREATMENT 5 Maec e aT 6 UNE NR RR 8 DILUTION AND INITIAL HANDING INSTRUCTIONS aaa 8 HANDLING AND STORAGE OF REPROCESSED DIALYZERS 10 IX RENALIN 100 PRESENCE TEST PRIOR TO DIALYZER RINSE 11 X RECOMMENDED DIALYZER RINSE PROCEDURE 13 XL RENALIN 100 RESIDUAL TEST FOLLOWING DIALYZER RINSE 16 RENALIN 100 SPILL PROCEDURE ccinn 17 6 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 Instructions for
8. ER 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 STE RILANT TO MIX WITH ALKALINE SUBSTANCES SUCH AS BLEACH SODIUM HYPOCHLORITE WARNING OXIDIZER AVOID CONTACT WITH COM BUSTIBLE MATERIALS 3 Instructions for Use Instructions for Use CAUTION RENALIN 100 COLD STERILANT WILL UNDERGO RAPID DECOMPOSITION IF ALLOWED TO CONTACT METAL DUST ORGANIC MATERIALS OR IF IT IS DILUTED WITH WATER FAILING TO MEET ANSI AAMI STANDARDS STORE RENALIN 100 COLD STERILANT UPRIGHT IN THE ORIGINAL SHIPPING CARTON STORE RENALIN 100 COLD STERILANT IN ORIGINAL UNOPENED CONTAINER NEVER TAMPER WITH VENT CAP DO NOT STORE RENALIN 100 COLD STERILANT IN DIRECT SUNLIGHT MAINTAIN STORAGE TEMPERATURE BETWEEN 32 75 0 C 24 C THE EXPIRATION DATE OF RENALIN 100 IS INDICATED ON THE CONTAINER LABEL THE EXPIRATION OF 1 RENALIN 100 SOLUTION IS 24 HOURS FROM THE TIME OF DILUTION FOR ANY 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 II 100 AND RENATRON PA 100 SYSTEM TO AVOID BEING SPRA
9. IFFERENCES DURING ANY PART OF THE REUSE PROCEDURE MAY RESULT IN INCREASING OR INITIATING PRESSURE BUILD UP IN THE DIALYZER DURING STORAGE WARNING REPROCESSED DIALYZERS 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 DIALYZERS 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 AFTER STORAGE AND BEFORE THE DIALYZER IS RINSED AND CLINICALLY USED A RENALIN 100 PRESENCE TEST SHOULD BE PERFORMED CAUTION ANSI AAMI RECOMMENDED PRACTICES FOR REUSE OF HEMODIALYZERS STATES THAT A REPROCESSED DIALYZER SHOULD BE USED ONLY BY A SINGLE PATIENT Renalin 100 Presence Test 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 proportioned 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 100 SOLUTION TO SPRAY FROM THE PORTWHEN CAPIS REMOVED BEPREPARED TO DIRECT THIS S
10. INSTRUCTIONS FOR USE p e COLD STERILANT renoailini00 Cold Sterilant Concentrate For use with the Renatron PA 100 Series and Renatron II 100 Series Dialyzer Reprocessing Systems RENALIN and RENATRON are registered trademarks of Minntech Corporation All Rights Reserved MINNTECH 4 renal systems Disinfectants Sterilants e 9 9 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 Instructions for Use IT IS A VIOLATION OF U S A FEDERAL LAW TO USE THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING A READTHISMANUALCOMPLETELY PRIOR TO USING RENALIN 100 COLD STERILANT FAILURE TO FOLLOW INSTRUCTIONS IN THIS MANUAL MAY RESULT IN INJURY RETAIN THIS MANUAL FOR FUTURE REFERENCE A READ THE MACHINE INSTRUCTION MANUAL COMPLETELY PRIOR TO USING RENALIN 100 COLD STERILANT FOR DIALYZER REPROCESSING WITH THE RENATRON PA 100 SERIES AND RENATRON 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 DIALYZER
11. ONED RENALIN 100 SOLUTION MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO CLINICAL USE CAUTION DO NOT CONNECT DIALYSATE SUPPLY LINES TODIALYZER PRIOR TOBLOOD COMPARTMENT RINSE OF PROPORTIONED RENALIN 100 SOLUTION DO SO WILL RESULT IN AIR GENERATION WITHIN THE DIALYZER FIBERS FROM RENALIN 100 REACTION WITH WARM DIALYSATE EXCESS AIR MAKESIT DIFFICULT TO PRIME THE DIALYZER AND TO RINSE STERILANT FROM THE FIBERS 1 Place the 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 Route the arterial line on the dialysis machine Open the arterial red 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 arterial blood line to the dialyzer at this time Do not occlude the pump segment of the arterial blood line in the blood pump at this time 4 Clamp all monitor and heparin lines This may be accomplished by connecting each line to its appropriate connector on the dialysis machine 5 Connect the saline administration priming set to the saline line 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 tubin
12. PRAY INTO AN APPROPRIATE BASIN OR WASTE CONTAINER WHEN THE CAP IS REMOVED e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 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 Test 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 gray or blue black This 15 positive result and indicates peracetic acid levels of 500 ppm or greater f Any results other than blue gray or blue black is a negative result and indicates peracetic acid levels less than 500 ppm Reprocessed dialyzers that test negative 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
13. Renal Systems Test Strip Reference Chart Storage Conditions Test Stip P N Use Unopened Opened Cool dry place Room temperature Concentration test 39 F 104 F Do not refrigerate 500 7838 000 following reprocessing 4 C 40 C Tightly reclose vial Do not refrigerate when not in use Cool dry place Room temperature Renalin Indicator 78199 000 Concentration test 39 F 104 F Do not refrigerate following reprocessing 4 40 Do not refrigerate Tightly reclose vial when not use dry place Residual test following 39 F 1056 dialyzer rinsing 4 C 40 C Cool dry place Do not refrigerate Tightly reclose vial when not in use Renalin Residual 78198 000 NOTE RENALIN RESIDUAL TEST STRIPS SHOULD BE STORED IN A COOL AND DRY PLACE KEEP CONTAINER TIGHTLY CAPPED WHEN NOT IN USE CHECK EXPIRATION DATE ON CONTAINER PRIOR TO 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 connecti
14. S WITH THE RENATRON PA 100 SERIES AND RENATRON II 100 SERIES DIALY ZER REPROCESSING SYSTEM WHICH IS LABELED FOR USE WITH RENALIN 100 ANY SUBSEQUENT CLINICAL APPLICATION OR USE OF A HOLLOW FIBER 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 STERI LANT BY THE RENATRON PA 100 SERIES AND RENAT RON II 100 SERIES DIALYZER REPROCESSING SYSTEM IS FILLED WITH A PROPORTIONED RENALIN 100 SO LUTION HYDROGEN PEROXIDE AND PEROXYACETIC ACID THEPROPORTIONED 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 sd Instructions for Use Warranty and MINNTECH WARRANTS TO CUSTOMER THAT MINNTECH Limitation of POSSESSES GOOD AND MARKETABLE TITLE TO THE PRODUCT Damages 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 ARE IN COMPLIANCE WITH THE SPECIFICATIONS FOR THE PRODUCTS THE LIABILITY OF MINNTECH UNDER THIS LIMITED WARRANTY DOES NOT EXTEND TO ANY ABUSE OR MISUSE OF THE PRODUCTS ANY USE THAT IS CONTRAINDICATED USE THAT IS NOTIN ACCORD
15. USE BLEACH OR AMMONIA TO MOP UP SPILLED RENALIN 100 COLD STERILANT 2 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 drain is available in 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 baking 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 Instructions for Use References 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 materials in a deep sink a
16. WAY WITH LARGE QUANTITIES OF WATER SEE RENALIN 100 SPILL PROCEDURE IN THIS MANUAL IN CASE OF CONTACT WITH SKIN OR EYES IMMEDIATELY FLUSH WITH LARGE AMOUNTS OF WATER FOR AT LEAST FIFTEEN 15 MINUTES FOR EXPOSURE TO EYES REMOVE CONTACT LENSES AND CONTINUE TO FLUSH EYES THOROUGHLY WITH WATER FOR AT LEAST FIFTEEN 15 MINUTES PROMPT MEDICAL ATTENTION IS NECESSARY 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 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 FOR FURTHER INFORMATION CALL MINNTECH BV 31 45 5471 471 MINNTECH ASIA PACIFIC 11 65 6227 9698 INCHINA 8610 6567 846 TAIWAN 886 910 531 807 FOR CHEMICAL EMERGENCY SPILL LEAK FIRE EXPOSURE OR ACCIDENT CALL CHEMTREC 1 703 527 38 87 Statement of Practical Treatment Instructions for Use Description General Product Application Renalin 100 Cold Sterilant is intended dialyzer reprocessing with Renatron PA 100 Series Dialyzer Reprocessing System hereafter refered to as Renatron 100 and Renatron 100 Series Dialyzer 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 accordi
17. WITH PROPER CONDUCTIVITY FOR DIALYZER PRIMING TO ENSURE PATIENT SAFETY 22 Invert the dialyzer so that the arterial red end is up 9 9 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 Instructions for Use 23 Remove the cap from the arterial dialysate port Attach the dialysate exit line to the arterial red end of the dialyzer 24 Remove the cap from the venous dialysate port Attach the dialysate supply line to the venous blue end of the dialyzer CAUTION CONNECTING THE DIALYSATE SUPPLY LINE TO THE DIALYZER PRIOR TO FLUSHING APPROXIMATELY 500 ML OF SALINE THROUGH THE DIALYZER MAY CAUSE AN AIR LOCK IN THE DIALYZER FIBERS 25 Set the transmembrane pressure TMP at approximately 20 mmHg 26 Attempt to remove all air from the dialysate compartment by tipping the dialyzer 27 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 28 Turn on the blood pump at a flow rate of approximately 300ml min Set the fluid removal rate at 2 liters hr and recirculate for a minimum of 10 minutes On a dialysis machine without UF control set the dialysate pressure at 300 mmHg and recirculate for at least 10 minutes 29 When the TMP on the dialysis machine ramps up and the dialysate comes out of bypass unclamp the saline admi
18. YED 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 DIALYZERS AFTER STORAGE TO AVOID BEING SPRAYED WITH PROPORTIONAL RENALIN 100 SOLUTION AFTER STORAGE AND BEFORE RINSING DIALYZERS 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 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 9 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 RINSE KIDNEY MACHINE ACCORDING MANUFACTURER S INSTRUCTIONS FOLLOWING DISINFECTION STEPS USE AAMIQUALITY WATER FORRINSING KIDNEY MACHINES AFTER DISINFECTING WITHRENALIN 100 SOLUTION RECONTAMINATION OF MACHINES IS POSSIBLE IF RINSE WATER DOES NOT MEET AAMI QUALITY STANDARDS WHEN USED WITH KIDNEY MACHINES DO NOT HEAT RENALIN 100 COLD STERILANT ABOVE 75 F 24 C WHEN USED WITH KIDNEY MACHINES CHECK WITH MACHINE MANUFACTURER TO VERIFY COMPATIBILITY OF MATERIALS IF SPILLED FLUSH A
19. 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 in 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 Cap vial and shake to mix solution e Remove the cap and dip relative indicator test starch paper into the solution The test strip should promptly turn a dark blue or blue black This 15 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 dialyzers that test negative should be considered non sterile and not accepted CAUTION THE GRADUATED TEST VIAL AND CAP MUST CAREFULLY RINSED WITH AAMI ANSI STANDARD QUALITY WATER IMMEDIATELY AFTER EACH TEST TO AVOID A FALSE INDICATION ON SUBSEQUENT TESTS 9 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 WARNING A HOLLOW FIBER DIALYZER THAT IS REPROCESSED AND STERILIZED WITH RENALIN 100 COLD STERILANT BY THE RENATRON 100 REPRO CESSING SYSTEM IS FILLED WITH A PROPORTIONED RENALIN 100 SOLUTION HYDROGEN PEROXIDE AND PEROXYACETIC ACID THE PROPORTI
20. g sets which have the saline line incorporated into the pump segment inlet either clamp the pump segment or the blood line at the outlet of the pump segment 7 Route the 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 line to the dialyzer at this time 8 Clamp all venous monitor lines This may be accomplished by connecting each line to its appropriate connector on the dialysis ere ee eee ee eee oe ee Recommended Dialyzer Rinse Procedure Instructions for Use 9 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 line and the arterial red access end of the blood line 10 Clamp the arterial blood line adjacent to its access patient end and close the arterial red access end cap 11 Open the dialyzer connector on the arterial blood line and position the open end over a container to collect saline overflow 12 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 13 Remove t
21. he blood port cap from the arterial red end of the dialyzer and attach the arterial blood line 14 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 dialyzer and attach the venous blood line 15 Remove the clamp from between the saline line 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 16 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 17 Continue 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 DIALYZER 18 Clamp the venous blood line adjacent to its access patient end 19 Clamp the saline administration priming set to prevent backflow 20 Remove the venous blood line from the venous blue access end cap and insert the end of the venous blood line into the open arterial red access end cap 21 Check that the dialysate has the correct conductivity and is at the proper temperature CAUTION USE ONLY DIALYSATE
22. isinfection fresh Renalin 100 Cold Sterilant should be used each time Do not allow 1 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 PROTECTI VE CLOTHING WHEN HANDLING RENALIN 100 COLD STERILANT WASH THOROUGHLY AFTER HANDLING CAUTION PRIOR USE IN THE RENATRON 100 RENALIN 100 COLD STERILANT MUST NOT BE DILUTED CAUTION ALWAYS STORERENALIN 100 COLD STERILANT UPRIGHT AND OUT OF DIRECT SUNLIGHT EXPOSURE TO SUNLIGHT 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 Dilution for 1 Renalin 100 Solution NOTE TO ASSURE EFFICACY MAKE FRESH 196 RENALIN 100 SOLUTION DAILY DO NOT ALLOW 196 RENALIN 100 SOLUTION TO SIT OVERNIGHT FOR USE THE FOLLOWING DAY 1 To make 196 Renalin 100 Solution from Renalin 100 Cold Sterilant 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 100 AAMI Quality Water 1 Renalin 100 Cold Sterilant Solution 5mL 495 mL 500 mL
23. l Instrumentation 1996 AAMI Standards and Recommended Practices Dialysis Vol 3 Arlington AAMI Hemodialysis systems p 37 9 9 e 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 18 Notes 9 9 9 06 9 9 9 9 9 9 o 9 9 9 9 9 9 o 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 19 Instructions for Use Notes 9 9 e o 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 Instructions for Use 20 9 9 9 0 9 9 9 9 9 9 9 9 9 9 9 9 9 o 9 9 9 9 8 9 9 9 9 9 9 9 9 9 9 9 9 NM Instructions for Use Minntech Corporation Minntech B V Minntech Asia Pacific Pte Ltd 14605 28th Avenue North Sourethweg 11 438 Alexandra Road Minneapolis 55447 U S A 6422 Heerlen 03 01 Alexandra Point Phone 763 553 3300 The Netherlands Singapore 119958 800 328 3340 Tel 31 45 5471471 Tel 65 6227 9698 renal systems 0 763 553 3387 Fax 31 45 5429695 Telephone in China 8610 6567 8446 Taiwan 886 910 531 807 50
24. nd thoroughly soak with cold water After soaking 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 be observed 4 Immerse any clothing contaminated with Renalin 100 solution in water and wash as soon as possible 5 For additional information contact Minntech Renal Systems 1 800 328 3340 within the U S A 31 45 5471 471 within Europe and 65 6227 9698 within Asia Renal Systems Part Number Reference Chart Item Renal Systems Part Number Dialyzer Blood Port Caps 78197 000 Dialyzer Dialysate Port Caps 78196 000 ISO Fitting Dialyzer Blood Port Caps 78397 704 Ventable Dialzyer Dialysis Port Caps 78208 000 Perassay 500 Directions for Use 50086 025 Perassay 500 Peracetic Acid Test Strips 78378 000 Renalin 100 Cold Sterilant 4 test kits 78397 970 Renalin 100 Cold Sterilant Instructions for Use 50090 720 Renalin Indicator Test Strips 78199 000 Renalin Residual Test Strips 78198 000 Renalin Residual Test Strips Directions for Use 50083 000 Renatron Service Manual 50101 000 13 AAMI Association for the Advancement of Medical Instrumentation 1996 AAMI Standards and Recommended Practices Dialysis Vol 3 Arlington AAMI Reuse of hemodialyzers p 99 2 AAMI Association for the Advancement of Medica
25. ng to label directions Renalin 100 Cold Sterilant may be used for manual dialyzer reprocessing Facilities practicing manual dialyzer reprocessing must independently validate their reprocessing protocols to establish safety and effectiveness 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 formaldehyde hydrogen peroxide and or bleach when used for dialyzer reprocessing 2 Post 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 All 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 AAMI ANSI Standard for Hemodialysis Systems If other local laws or requirements concerning water quality e g European Pharmacopoeia are available those should be applied b
26. nistration priming set 30 Check that the saline bag is not empty that the saline line is not clamped and that saline is flowing from the bag to the blood lines saline is dripping through the bulb in the administration line 31 After recirculating at a UF rate of 2 liter hr or negative pressure of 300 mmHg for ten minutes adjust the UF rate to near zero maintaining a slight negative pressure CAUTION RECIRCULATION AND A SLIGHT NEGATIVE PRESSURE SHOULD BE MAINTAINED IF SIGNIFICANT TIME ELAPSES BETWEEN RINSING THE DIALYZER AND PATIENT CONNECTION THIS PROCESS WILL PREVENT REBOUND OF THE CHEMICAL STERILANT 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 Instructions for Use Renalin 100 Residual Test Following Dialyzer Rinse Instructions for Use Proceed with residual testing as outlined below To perform residual test use Renalin Residual Test Strips P N 78198 000 1 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 a test strip from the tube and immediately replace the lid 3 Allow a few drops of saline to drip from the venous blood line onto a residual test strip Do not allow the saline to flow through or over
27. old Sterilant spills arrives in 8 damaged container What to do if be aware of the following precautions and procedures for disposal Renalin 100 AN Read warnings and precautions printed on bottles and cases Cold Sterilant WARNING RENALIN 100 COLD STERILANT CAN Spills CAUSE PERMANENT INJURY TO EYES OR SKIN OR CAUSE IRRITATION TO MEMBRANES IN THE NOSE THROAT OR LUNGS fRenalin 100 Cold Sterilant contacts eyes immediately flush eyes with cool running water for fifteen minutes lifting upper and lower lids intermittently Remove contact lenses and continue to flush eyes thoroughly with water for fifteen minutes Promptly seek medical attention 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
28. on 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 acid Packaging Item Weight Height Individual shipping Approx 328 carton 2 x 10 Liter 22 kg Container Dilution Requirements 1 Water used for manual dilution must meet or exceed the ANSI AAMI standards for Hemodialysis Systems and ANSI AAMI Heuse of Hemodialyzers Water used for manual dilution must be pre filtered through a 1 0 micron or smaller filter Water used for manual dilution must be at a temperature between 59 F 75 F 15 C 24 C Environmental Limits 1 Maintain storage temperature of Renalin 100 Cold Sterilant and proportioned Renalin 100 solution between 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 when stored according 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 5096 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 1 solution e g port cap d

Cold Sterilant Concentrate INSTRUCTIONS FOR USE

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