50090733/A RENATRON PA 100 BV
Contents
1. 4 Drip Tray single or dual Renatron PA 100 Series compatibility optional B Terminology For the purpose of clarity the following terminology will be used throughout this manual Water or AAMI quality water is water that meets or exceeds the following requirements a AAMI ANSI Standard for Hemodialysis Systems and AAMI Recommended Practice for the Reuse of Hemodialyzers b Containing no particles larger than 1 micron 2 Renalin 100 Cold Sterilant or Renalin 100 is a concentrated solution for use with the Renatron PA 100 Series System It is supplied as 10 liters of Renalin 100 Cold Sterilant in a 10 liter container for use by the Renatron PA 100 Series machine and for use making a 196 Renalin 100 mixture 3 Proportioned Renalin 100 Solution is the final diluted solution which has been further proportioned by the Renatron PA 100 Series machine This is the solution actually used for cleaning and sterilizing the dialyzer and the Renatron PA 100 Series 4 196 Renalin 100 Solution 1 part Renalin 100 Cold Sterilant to 99 parts AAMI quality water 5 Theterms equi pment machine device station or Renatron PA 100 Series are synonymous with each Renatron PA 100 Series Dialyzer Reprocessing unit of the overall Renatron PA 100 Series system and may be used interchangeably throughout this manual NOTE ALL TIMES AND FLOW RATES SPECIFIED IN THIS MANUAL ARE APPROXIMATE C General Sys2. The storage area should be a well ventilated cool area that is out of direct sunlight B Reprocessed dialyzers or dialyzers awaiting reprocessing should not be exposed to freezing temperature or sources of heat The recommended temperature range is 59 F 15 C to 75 F 24 C WARNING MINIMUM STORAGE TIME FOR REPROCESSED DIALY ZERS IS 11 HOURS CAUTION AFTER STORAGE AND BEFORE THE REPROCESSED DIALYZER IS RINSED AND CLINICALLY USED A SAMPLE OF FLUID SHOULD BE REMOVED FROM THE DIALYZER AND TESTED FOR THE PRESENCE OF RENALIN 100 USING PERASSAY 500 PERACETIC ACID INDICATOR STRIPS PART 78378 OR RENALIN INDICATOR TEST STRIPS PART 78199 REFER TO THE RENALIN 100 PRESENCE TEST PROCEDURE OUTLINED IN THE RENALIN 100 COLD STERILANT INSTRUCTIONS FOR USE PART 50090 720 AND THE TEST STRIP LABELING WARNING A HOLLOW FIBER DIALY ZER THAT IS REPROCESSED AND DISINFECTED BY THIS MACHINE IS FILLED WITH PROPORTIONED RENALIN 100 SOLUTION THE PROPORTIONED RENALIN 100 SOLUTI ON MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO CLINICAL USE USE THE RENALIN RESIDUAL TEST KIT PART 78198 TO VERIFY RESIDUAL RINSE OUT AS OUTLINED IN THE RENALIN 100 COLD STERILANT INSTRUCTIONS FOR USE PART 50090 720 CAUTION EXPOSING DIALY ZERS TO CYCLIC TEMPERATURE DIFFERENCES DURING ANY PART OF THE REUSE PROCEDURE MAY RESULT IN INCREASING OR INITIATING PRESSURE BUILDUP IN THE DIALY ZER DURING STORAGE IN THESE COND
3. 12 INTERLOCK error message appears when the START SANITIZE switch has been pressed and the sanitize interlock is not engaged 13 SANITIZE message appears when the machine saniti zation cycle is complete IMPORTANT TO ISOLATE THE STATION FROM THE ELECTRICAL SUPPLY Y OU MUST DISCONNECT THE CORD FROM THE POWER ENTRY MODULE LOCATED IN THE LOWER RIGHT WHEN VIEWED FROM THE FRONT SIDE OF THE UNIT BACKSIDE THE UNIT SHOULD BE SITUATED TO ALLOW AS MUCH ROOM ON THE RIGHT SIDE AS POSSIBLE ALLOWING EASY ACCESS CAUTION TOTAL SYSTEM CHASSIS RISK CURRENT SHOULD NOT EXCEED 100 MICRO AMPS NOTE Report any damage promptly to the shipping company and make claim for compensation Damage incurred during shipment is not covered by the machine warranty Please save the shipping container for use in returning machine if repairs are necessary NOTE All plumbing hoses and lines are cut to length and calibrated at the factory and must not be modified from the original lengths or sizes Only factory authorized service personnel should repair or replace these items CAUTION PRIOR TO CONNECTING ALL WIRING MUST BE CHECKED TO ENSURE PROPER POLARITY AND ALL GROUNDS MUST BE CHECKED TO ENSURE CONTINUITY CAUTION WHEN THE WATER SUPPLY FEED LINE IS CONNECTED TO THE RENATRON PA 100 SERIES IT MUST BE EQUIPPED WITH AN ON OFF VALVE THAT WILL PERMIT SHUTTING OFF THE FLOW OF WATER TO THE RENATRON PA 100 SERIES WHEN NOT IN USE CAUTION PROPER WATE
4. IRRITANT AVOID CONTACT WITH EYES OR SKIN REFER TO LABEL INSTRUCTIONS FOR CAUTIONS AND REMEDY DO NOT USE SUBSTITUTE CHEMICAL SOLUTIONS IN THIS PROCEDURE Formula 409 Cleaner Degreaser Formula 4099 will not react with trace levels of Renalin 100 Cold Sterilant To ensure Formula 409 contact with Renalin 100 is minimized and to ensure Formula 409 is rinsed completely from the Renatron PA 100 Series stati on this procedure should be performed in the order listed below 1 Remove the uptake tube from the Renalin 100 container and make sure excess Renalin 100 drains back into the container Cover the open Renalin 100 container 2 Placethe uptake tube into a container of purified water one gallon or more 3 Pressthe ON switch and select program 00 Connect external hoses in sanitize configuration 4 Pressthe START SANITIZE and DISPLAY switches Allow the machine to operate to completion of PROGRAM STEP 75 and press the OFF switch No problems will occur if machine operates past step 75 before turning off 5 Pressthe ON switch and repeat procedure steps 3 and 4 above This action clears Renalin 100 from the uptake hose and replaces it with pure water 6 Removethe uptake tube from the pure water and allow excess water to drain out of the uptake tube 7 Placethe uptake tube into container of Formula 409 Do not use a substitute chemical as it may damage the materials in the machine 8 Pressthe ON s
5. Renatron PA 100 Series volume value must be within 3 ml of the Calibrated Volume Cell If the Renatron PA 100 Series volume is not within 3 ml adjust P3 Turn P3 clockwise to decrease displayed volume value Turn P3 counterclockwise to increase displ ayed volume value Example 1 Volume Cell value equals 60 etched value Volume displayed by machine equals 56 Difference in milliliters equals 4 ml Adjust P3 Figure 3 1 25 turns counterclockwise per ml difference in volume value to eliminate the volume error Therefore a 4 ml difference will require 5 turns counterclockwise Example 2 Volume Cell value equals 60 etched value Volume displayed by machine equals 64 Difference in milliliters equals 4 ml Adjust P3 Figure 3 1 25 turns clockwise per ml difference in volume value to eliminate the volume error Therefore a 4 ml difference will require 5 turns clockwise Note If P3 is adjusted while the volume is being displayed no change will be shown in the display The change in volume value will be evident only after pressing the RESET and START PROCESS switches to retest the volume 21 Repeat steps 15 20 until displayed Renatron PA 100 Series volume is within 3 ml of the Calibrate Volume Cell 22 Replace the Renatron PA 100 Series cover securing it with the two screws on each side The screw should be thumb tightened CAUTION THE COVER SHOULD ALWAYS BE ON THE RENATRON PA 100 SERIES FOR NORMAL OPERATION
6. be damaged 3 Press switch SEL and will be displayed 4 Pressthe MUTE AND RESET switches together until program 00 is displayed 5 Press the HOLD TO SET switch while adjusting the SET knob to display 255 in the VOLUME window 18 6 Press the START PROCESS switch A light will appear in corner of the START PROCESS switch 7 Press the OFF switch immediately after PROGRAM STEP 05 has been completed There will be approximately 5 seconds in which to press OFF 8 On the hydraulic side view the lower tank scribe line zero line located about 3 mm above bottom gray gasket Figure 2 Water level should be even with thelower tank scribeline If itis proceed to step 9 in this procedure If not adjust P1 Figure 3 and repeat steps 3 8 until water level is even with the lower tank scribe line Note Adjust P1 Figure 3 clockwise to raise level in tank counterclockwise to lower level for zero line adjustment Adjust one turn to change the level approximately 3 mm 9 Press ON switch SEL and will be displayed 10 Press the MUTE and RESET switches together until program 00 is displayed 11 Press the HOLD TO SET switch while adjusting the SET knob to display 255 in the VOLUME window 12 Press the START PROCESS switch A light will appear in corner of the START PROCESS switch 13 Immediately at the end of PROGRAM STEP 12 press the OFF switch
7. in a process cycle Restart machine in PROGRAM STEP 83 to purge fluid from hydraulic pathway for shipping purposes only 4 START SANITIZE switch initiates a machine cleaning cycle and repeats most program steps after an alarm situation in sanitize cycle NOTE Sanitize can only be initiated if reprocessing program 00 CH or HF is being displayed in the step display not from the standby mode 5 MUTE switch mutes audio alarm 6 RESET switch returns machine to last program mode used and VOLUME display to SEL 7 DISPLAY switch allows operator to blank the display from viewing the actual program steps 8 HOLD TO SET switch when touched activates VOLUME display Allows operator to view displayed value of minimum acceptable blood compartment reference volume SET into the machine 9 SET knob allows the operator to set the minimum acceptable blood compartment reference volume prescri bed by the attending physician in the manual mode of operation B Renatron PA 100 Series Station Indicators and Error Messages 1 VOLUME DISPLAY indicates a Blood compartment volume test measurement or b Blood compartment reference volume 2 PROGRAM STEP is a display that allows the operator to view the actual program step number and programmed mode of operation Display is deactivated acti vated by sequentially touching DISPLAY switch 3 TANK VOLUME error message appears when the internal mi
8. the new location Remove Instruction Manual and Calibrated Volume Cell Save carton for future use in Service or evaluation return Remove optional drip tray s from shipping carton s and place in desired location on sturdy level bench Place the machines in appropriate mounts on the drip tray The Renatron PA 100 Series must be level Machines that are not level may have a 0 8 ml error in the initial volume that is displayed when measuring Calibrated Volume Cell Placethe siphon tube marked with the word Renalin 100 in a container of Renalin 100 Solution Connectthe quick disconnect coupling which is located at the end of the Renalin 100 uptake hose to the siphon uptake tube Make service connections to power water and drain in accordance with Specifications Section Make sure that the water pressure gauge block is connected between the water inlet source and the Renatron PA 100 Series Securethe water pressure gauge block to the back of the drip tray usingthe screws provided Be absolutely certain that no water leaks exist and all connections are secure Insert the Calibrated Volume Cell between the arterial and venous lines Record volume value etched on cell here Connect the dialysate line quick disconnects together using the plastic male to male connector interlock connector Open the water supply valve completely Push the switch labeled ON SEL will be displayed in the VOLUME disp
9. 01 000 Renalin 100 Cold Sterilant with 5 test kits 78397 970 Renalin Residual Test Strips 78198 000 Renalin Indicator Test Strips 78199 000 Perassay 500 Peracetic Acid Test Strips 78378 000 Dialyzer Dialysate Port Caps 78196 010 Ventable Dialyzer Dialysate Port Caps 78208 000 Dialyzer Blood Port Caps 78197 010 ISO Fitting Dialyzer Blood Port Caps 78329 000 Formula 4099 Cleaner Degreaser 78273 001 25 Instruction Manual Notes Instruction M anual 26 y 3 aN INNTECH nail systems Minntech Corporation 14605 28th Avenue North Minneapolis MN 55447 U S A Phone Toll Free Fax 763 553 3300 800 763 328 3340 553 3387 Minntech B V Sourethweg 11 6422 PC Heerlen The Netherlands Tel 31 45 5471471 Fax 31 45 5429695 Minntech BV Singapore Representative Office 59A Duxton Road Singapore 089523 Tel 65 227 9698 Fax 65 225 6848 50090 733 A 2001 Minntech
10. 100 Series station should be thoroughly cleaned and emptied It is recommended that each unit be repackaged in the original manner for maximum protection The original shipping carton can be saved and used for this purpose If the original packing is not available contact your Minntech Renal Systems Distributor for the appropriate packi ng and shipping instructions 22 B Documentation Any system being returned for service should be accompanied by a letter stating 1 The model number of the system device 2 Theserial number of the system device if applicable 3 Theaddress to which the deviceis to be shipped after repair 4 The address to which the repairs are to be billed if not covered by the warranty and purchase order for the repairs 5 A description of the problem for which the deviceis being returned Important Note Because Minntech Renal Systems has no knowledge or control over any third party s service work or the affect such work may have on the Renatron System s operation or performance Minntech Renal Systems disclaims any liability for any damages whatsoever resulting from a change in the operation or performance of the Renatron System or any personal injury directly or proximately resulting from any repairs made or attempted to be made by any person other than a factory representative of Minntech Renal Systems If Minntech Renal Systems replaces non Renal Systems parts the customer will be charged in full for all repl
11. 14 On the hydraulic side view the upper tank scribe line 507 mark located approxi mately in the middle of thetank Figure 2 Water level should be even with the upper tank scribe line 6 5 mm If itis proceed to step 15 in this procedure If not adjust P2 Figure 3 and repeat steps 9 14 until water level is even with the upper tank scribe line Note Adjust P2 Figure 3 counterclockwise to raise level in tank clockwise to lower level Adjust one turn to change the level approximately 3 mm 15 Press ON switch SEL and will be displayed 16 Press the MUTE AND RESET switches together until program 00 is displayed 17 Press the HOLD TO SET switch while adjusting the SET knob to display 255 in the VOLUME window 18 Press the START PROCESS switch A light will appear in the corner of the START PROCESS switch Figure 2 Figure 3 Tank Zero Level Potentiometer P1 Tank Gain Control Q Potentiometer P2 w _ VOLUME Meter Gain Potenti ometer P3 Upper Tank Scribe Line 507 Mark f d J f e Lower Tank 4 Scribe Line T Zero Line Y yy ws ws fO 19 Instruction Manual Maintenance Instruction M anual 19 Allow the Renatron PA 100 Series to continue operating until the Volume Fail alarm has occurred in PROGRAM STEP 35 Push the MUTE switch to silence the audio alarm DO NOT PRESS THE RESET SWITCH 20 The displayed
12. ADE OR EQUIVALENT CAUTION IF THE DEVICE IS USED IN A MANNER NOT SPECIFIED BY THE MANUFACTURER THE PROTECTION PROVIDED BY THE DEVICE MAY BE IMPAIRED CAUTION DO NOT USE CHEMICALS OTHER THAN RENALIN 100 COLD STERILANT WITH THIS MACHINE CAUTION WATER SUPPLIED TO THIS SYSTEM MUST MEET THE REQUIREMENTS LISTED IN SPECIFICATIONS SECTION THE RS 8310 100 SERIES OR 8320 100 SERIES DOES NOT PERFORM WATER TREATMENT CAUTION DO NOT OPERATE THE RENATRON PA 100 SERIES MACHINE WITH THE COVER OFF UNLESS SPECIFICALLY INDICATED IN THIS MANUAL CAUTION ALL PERSONNEL USING THIS DEVICE SHOULD BE FAMILIAR WITH THE INFORMATION CONTAINED IN THIS MANUAL CAUTION IT IS THE RESPONSIBILITY OF THE PRESCRIBING PHYSICIAN TO ENSURE THAT THE OPERATORS OF THIS DEVICE ARE PROPERLY TRAINED AND TECHNICALLY COMPETENT CAUTION DO NOT REMOVE ANY WARNINGS CAUTIONS OR DESCRIPTIVE LABELING FROM THIS MACHINE OR THE POWER CORD SUPPLIED WITH THIS MACHINE CAUTION ALL PLUMBING HOSES AND LINES ARE CUT TO LENGTH AND CALIBRATED AT THE FACTORY AND SHOULD NOT BE MODIFIED FROM THE ORIGINAL LENGTHS OR SIZES ONLY FACTORY AUTHORIZED SERVICE PERSONNEL SHOULD REPAIR OR REPLACE THESE ITEMS WARNING RENALIN 100 COLD STERILANT IS USED IN CONJUCTION WITH THIS DEVICE RENALIN 100 COLD STERILANT IS CORROSIVE AND CAN CAUSE EYE DAMAGE AND SKIN IRRITATION WEAR EYE PROTECTION RUBBER GLOVES AND PROTECTIVE CLOTHING WHEN HANDLING THIS SOLUTION AND DURING T
13. ERIES THE DIALY ZER MUST BE REMOVED CAREFULLY REMOVE THE DIALYZER AFTER WRAPPING ALL CONNECTIONS WITH DISPOSABLE ABSORBENT MATERIAL PRESSURE BUILD UP MAY CAUSE FLUIDS TO SPRAY The Renatron PA 100 Series station s sit on a single or dual unit drip tray that will catch fluid drippage from the machines A water pressure gauge block with one or two outlets as appropriate is attached to the drip tray The pressure gauge displays the pressure of the water supplied to the Renatron PA 100 Series station s The steps of the reprocessing process are given below 1 Performed by Operator a Operator connects the dialysate outlet port on the dialyzer to the connector mounted on the front panel marked DIALYSATE OUTLET SANITIZE INTERLOCK This connection acts as the dialyzer holding fixture b Operator connects the system s ARTERIAL INLET VENOUS OUTLET and DIALYSATE INLET lines to the dialyzer The operator sets the blood compartment reference vol ume by touching the HOLD TO SET switch and turning the SET knob until the desired value is displayed in the VOLUME display The value for the blood compartment reference vol ume must be determined by the attending physician for the type and size of the dialyzer to be reprocessed The operator also selects the appropriate reprocessing program mode by pressi ng the MUTE and RESET switches NOTE Itis recommended that the operator set the reference volume of the dialyzer to b
14. HE OPERATION OF THE RENATRON PA 100 SERIES MACHINE CAUTION THE OPERATOR SHOULD BE FAMILIAR WITH THE SAFE HANDLING TECHNIQUES FOR THE MACHINE AND THE RENALIN 100 COLD STERILANT AND WITH THE RECOMMENDED FIRST AID PROCEDURES IN CASE OF CONTACT WITH OR EXPOSURE TO RENALIN 100 COLD STERILANT WARNING DO NOT ALLOW RENALIN 100 COLD STERILANT TO MIX WITH ALKALINE SUBSTANCES SUCH AS BLEACH SODIUM HYPOCHLORITE A Components the Renatron PA 100 Series System consists of Descri pti on 1 A Renatron PA 100 Series station a The solid state electronics control section b Thehydraulic section c Thedialysate inlet and outlet port connection and the arterial and venous port connection lines d TheRenalin 100 uptake hose Thedrain line hose 2 Materials for connection of the Renatron PA 100 Series station to existing in house water supplies consisting of a Water pressure gauge block for attachment between one or two Renatron PA 100 Series stati ons and the water outlet from the dialysis center Mounts on the drip tray b 1 1 85 m water hose with a female Hansen type connector for attachment to the water gauge block and a female garden hose connector for attachment to the dialysis center water outl et C 1 1 85 m drain hose for each Renatron PA 100 Series 5 Instruction Manual Instruction M anual 3 One volumetric calibration cell for periodic checking of the Renatron PA s 100 Series operation
15. INSTRUCTION MANUAL renetrorn 100 Series Dialyzer Reprocessing System MODEL RS8310 MODEL RS8320 100 SERIES S N S 1 000 UP RENALIN and RENATRON are registered trademarks of Minntech Corporation Printed and assembled in the United States All Rights Reserved INNTECH AU renal systems R Section 10 11 12 13 14 15 16 17 18 Topic Indications Contraindications Warnings and Precautions Description Specifications Description of Controls Renatron PA 100 Series Installation Instructions Daily Machine Sanitize Procedure Operating Procedures Storage and Handling for Reprocessed Dialyzers Calibration and Adjustment Renatron PA 100 Series Calibration Procedure Maintenance Service Warranties Limitations Explanation for Symbols Technical Service Centers Part Number Listings 10 14 14 18 18 18 20 22 23 24 24 25 Contents Instruction Manual Indications Contraindications Warnings and Precautions Instruction M anual Read this Manual and the Renalin 100 Cold Sterilant Instructions for Use prior to using the Renatron PA 100 Series Dialyzer Reprocessing System Failure to follow the instructions for use may result in injury Retain this manual for future reference CAUTION ONLY HOLLOW FIBER DIALY ZERS SHOULD BE PROCESSED AS SPECIFIED IN THIS MANUAL CAUTION U S A FEDERAL LAW REST
16. ITIONS A VENTABLE DIALY ZER DIALYSATEPORT CAP SHOULD BE USED A VENTABLE DIALY ZER DIALYSATE PORT CAP IS AVAILABLE FROM MINNTECH RENAL SYSTEMS PART 78208 READ THE PORT CAPS LABELING BEFORE USE Each day before reprocessing dialyzers ensure that the Calibrated Volume Cell is installed between the arterial and venous lines Before checking calibration make sure machine is level and if machine is not level retest measurement of Volume Cell after leveling machine Push ON switch select Program mode 00 then push and hold SET and put in 255 Push START PROCESS and operate until volume is displayed in Step 35 Compare this value to value etched on Volume Cell These values should agree within 3 ml If these values do not agree within 3 ml check the Renatron PA 100 Series calibration as outlined below Note If the Renatron PA 100 Series continues to fail the calibration verification day after day contact your Minntech Renal Systems Distributor WARNING SHOCK HAZARD WHEN ADJUSTING TRIM CONTROLS VGC1 BE CAREFUL NOT TO TOUCH ELECTRONIC CONNECTIONS Note Before removing the top cover MAKE ABSOLUTELY CERTAIN there are no loose water connections or potential for fluid leakage ANY FLUID DAMAGE to internal electronics is NOT COVERED by machine warranty 1 Insert Calibrated Volume Cell between arterial and venous lines 2 Remove the two screws from each side of the cover and lift off the cover Place the cover where it will not
17. MUST BE PERFORMED PRIOR TO REPROCESSING DIALY ZERS INTENDED FOR PATIENT USE Dai ly A The Renatron PA 100 Series station must be sanitized once each day Perform the following procedure at end of reprocessing day Machine ap d eke 1 Ensure that the Renalin 100 storage tank contains at least 1 2 5 cm of Renalin 100 Sanitize ao Procedure 2 Connect the ARTERIAL INLET and VENOUS OUTLET lines to the calibration cell 3 Attach the DIALYSATE INLET line to the DIALYSATE OUTLET SANITIZE INTERLOCK connector using the male male fitting attached to the front of the machine 4 Wipeclean all external surfaces on the Renatron PA 100 Series with fresh 1 Renalin 100 Solution or full strength Actril solution 5 Check that the VOLUME display indicates SEL and program mode 00 CH or HF are displayed in the PROGRAM STEP display 6 Push the START SANITIZE switch to start the cycle The machine will automatically sanitize itself 7 Press machine OFF switch when the machine cycles to PROGRAM STEP 83 A SANITIZE message will be displayed NOTE A sanitize holding period of six hours or more will expose the machine s fluid pathways to Proportioned Renalin 100 Solution for a time consistent with the disinfection time indicated in the Renalin 100 Cold Sterilant labeling If the START PROCESS switch is pressed after entering PROGRAM STEP 83 total sanitize cycle time will be approximately seventee
18. Note If Renatron PA 100 Series will not calibrate please call your Minntech Renal Systems Distributor for assistance The following procedures will help maintain peak performance of the Renatron PA 100 Series Dialyzer Reprocessi ng System If at any time during this process you have a question or concern please contact your Minntech Renal Systems Distributor for additional information A Exterior Inspection the Renatron PA 100 Series stati on should be inspected periodically for any defects such as the following list 1 Bent or broken switches Cracks in cover Corroded metal parts Cut or frayed hoses or electrical cords 2 3 4 Looseor missing hardware 5 6 Cracksin the Front Mask 7 Excessive protein deposits in the tubing If necessary see the Formula 409 Service Cleaning Procedure in this section CAUTION USE OF A RENATRON PA 100 SERIES ON WHICH ONE OR MORE OF THE ABOVE CONDITIONS EXIST SHOULD BE DISCONTINUED UNTIL THE DEFECT IS CORRECTED AND THE SYSTEM OPERATION IS VERIFIED CAUTION CARE SHOULD BE TAKEN TO AVOID EXCESS MOISTURE WHICH COULD FLOW INTO THE RENATRON 100 SERIES CASE ASSEMBLY BLOOD MAY BE REMOVED FROM THE EXTERIOR OF THE RENATRON PA 100 SERIES WITH FRESH 1 RENALIN 100 SOLUTION OR FULL STRENGTH ACTRIL SOLUTION DO NOT USE ANY OTHER CLEANERS AS THEY MAY BE INCOMPATIBLE WITH THE MATERIALS IN THE MACHINE 20 B Cleaning The exterior of the Renatron PA 100 Series station shoul
19. R SYSTEM OPERATION MUST BE VERIFIED SEE SPECIFICATIONS SECTION V FOR WATER REQUIREMENTS NOTE ALWAYS USE THE RENALIN 100 COLD STERILANT CONTAINER AS A SUPPLY TANK FOR THE RENATRON PA 100 SERIES DO NOT USE ANY OTHER TYPE TANK OR CONTAINER CAUTION ALWAYS STORE THE RENALIN 100 COLD STERILANT CONTAINER UPRIGHT AND OUT OF DIRECT SUNLIGHT EXPOSURE TO SUNLIGHT DAMAGES THE CLEANING AND DISINFECTING QUALITIES OF THE RENALIN 100 COLD STERILANT NOTE RENALIN 100 COLD STERILANT CAN BE KEPT OUT OF SUNLIGHT BY KEEPING THE RENALIN 100 COLD STERILANT CONTAINER IN THE ORIGINAL SHIPPING CARTON A Verify suitable service connection 1 Water pressure should be 20 PSI minimum 137 9 Pa 1 38 Bars at 1 75 liter minute average flow rate 12 2 Water quality must meet or exceed water requirements listed in Specifications Section 3 If static no flow water pressure exceeds 55 psig 379K Pa 3 79 Bars make sure the static pressure is reduced to below 55 psig Dynamic pressure displayed must be 20 psig 138K Pa 1 38 Bars or greater in step 04 Optimal dynamic water pressure is between 35 40 psig 241 276 K Pa 2 41 2 76 Bars Remove the machine from shipping carton and inspect for possible damage incurred during shipment Lift the machine by placingfingers under the rear corners of the station pulling the station close to the body and lifting while keepingthe back straight Keep the station closeto the body while carryingto
20. RAM MODE ACCEPTABLE FOR A PARTICULAR TYPE AND SIZE HOLLOW FIBER DIALYZER THIS REFERENCE VOLUME AND PROGRAM MODE MUST BE SET FROM THE FRONT PANEL MANUALLY OR INITIALLY ENTERED INTO THE DATABASE TO ALLOW THE COMPUTER TO AUTOMATICALLY SET THESE VALUES BEFORE REPROCESSING A DIALYZER IT IS STRONGLY RECOMMENDED THAT THE MINIMUM ACCEPTABLE REFERENCE VOLUME BE GREATER THAN 8096 OF THE NEW VOLUME CAUTION IT IS IMPORTANT FOR THE OPERATOR TO VERIFY THAT THE BLOOD COMPARTMENT REFERENCE VOLUME SET ON THE MACHINE MANUALLY OR AUTOMATICALLY IS CORRECT FOR EACH DIALYZER TO BE REPROCESSED E Reprocessing the Dialyzer on the Renatron PA 100 Series station 1 Push the switch labeled ON SEL will be displayed in the VOLUME display window and will appear in the PROGRAM STEP display window 2 Push the RESET switch and the MUTE switch at same time to display the proper program mode in the PROGRAM STEP display window for the dialyzer to be reprocessed i e 00 CH HF Sequentially press the RESET and MUTE switches at the same time to advance the Renatron PA 100 Series station to the desired program mode 3 Touch and hold the HOLD TO SET switch 4 Adjustthe SET knob until the VOLUME display indicates the physician s prescribed blood compartment reference volume for the dialyzer to be reprocessed 5 Touch the START PROCESS switch The Renatron PA 100 Series station will now reprocess the dialyzer in the manner described
21. RICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN WARNING THE RENATRON PA 100 SERIES SYSTEM IS INTENDED EXCLUSIVELY FOR IN VITRO CLEANING TESTING AND DELIVERY OF PROPORTIONED RENALIN 100 SOLUTION TO THE DIALYZER ANY SUBSEQUENT CLINICAL APPLICATION OR USE OF A HOLLOW FIBER DIALYZER THAT HAS BEEN PROCESSED BY THE MACHINE IS THE SOLE RESPONSIBILITY OF THE ATTENDING PHYSICIAN WARNING A HOLLOW FIBER DIALYZER THAT IS PROCESSED ON THIS MACHINE IS FILLED WITH A PROPORTIONED RENALIN 100 COLD STERILANT SOLUTION THE PROPORTIONED RENALIN 100 COLD STERILANT SOLUTION MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO CLINICAL USE The Renatron PA 100 Series Dialyzer Reprocessing System is indicated for the in vitro rinsing cleaning testi ng and delivery of proportioned Renalin 100 Cold Sterilant sol ution to hollow fiber dialyzers The Renatron PA 100 Series system is indicated for use only with Renalin 100 Cold Sterilant solution This deviceis not designed sold or intended for use except as indicated ADDITIONAL WARNINGS AND PRECAUTIONS THAT APPLY TO SPECIFIC PROCEDURES ARE FOUND IN APPROPRIATE PLACES THROUGHOUT THIS MANUAL DANGER EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS CAUTION DISCONNECT POWER SUPPLY CORD BEFORE SERVICING WARNING GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THIS DEVICE IS CONNECTED TO A RECEPTACLE MARKED HOSPITAL GR
22. aced parts Minntech warrants to customer that Minntech possesses good and marketable title to the product sold to the customer and that the product i shall be free from defects in material and workmanship at the time of shipment and under normal use and service for a period of one year from the date of shipment and ii arein compliance with the specifications for the product The liability of Minntech under this limited warranty does not extend to any abuse or misuse of the product or any repair or attempt to repair the product by the customer which shall void this warranty If the product does not meet this limited warranty Minntech s sole obligation shall beto repair or replace the product provided that the product is returned to Minntech prepaid within one year of the date of shi pment and this shall be the customer s exclusive remedy Under no circumstances will Minntech be liable for any direct or indirect incidental or consequential loss damage or expense of any kind including without limitation loss of profits economic loss whether such claim is based on warranty contract tort or otherwise This limited warranty is lieu of all other warranties whether express or implied including without limitation any warranty for suitability fitness for a partcular purpose or absence of hidden defects No person has any authority to bind Minntech Renal Systems to any other representati on or warranty with respect to these products an
23. aces of the dialyzer arterial blood port using gauze soaked in fresh 1 Renalin 100 Solution or full strength Actril solution 5 Placea disinfected blood port cap See page 16 F 1 a b on the dialyzer arterial blood port 6 Disconnect the VENOUS OUTLET line from the dialyzer Wipe end of line with gauze saturated with 1 Renalin 100 Solution or full strength Actril solution 7 Wipe the external surfaces of the dialyzer venous blood port with gauze soaked in fresh 1 Renalin 100 Solution or full strength Actril solution 8 Place a disinfected blood port cap See page 16 F 1 a b on the dialyzer venous blood port 9 Disconnectthe dialysate outlet of the dialyzer from the DIALYSATE OUTLET SANITIZE INTERLOCK connector on the Renatron 100 Series 10 Wipe the external surfaces of the dialysate outlet port with gauze soaked in fresh 196 Renalin 100 Solution or full strength Actril solution Install a disinfected dialysate port cap See page 15 F 1 a b on the dialysate outlet port of the dialyzer 11 Disconnect the DIALYSATE INLET line from the dialysate inlet port and temporarily install it on the holding bracket mounted on the side of the DIALY SATE OUTLET SANITIZE INTERLOCK post on the Renatron PA 100 Series station 12 Wipe the external surfaces of the dialysate inlet port with gauze soaked in fresh 196 Renalin 100 Solution or full strength Actril solution Install a disinfected dialysate port c
24. achine enters PROGRAM STEP 97 and the SANITIZE COM PLETE message reappears 14 Press the OFF switch when the SANITIZE COMPLETE message appears in PROGRAM STEP 97 15 Remove the uptake tube from the container of pure water and allow excess water to drain from uptake tube 16 Place the uptake tube in a container of unexpired Renalin 100 17 Press ON select program 00 and press the START SANITIZE and DISPLAY switches Allow the machine to operate to completion of PROGRAM STEP 75 and press OFF switch This action clears the water from the uptake hose and replaces it with Renalin 100 Solution 18 Press ON select program 00 and press the START SANITIZE and DISPLAY switches Allow the machine to operate to PROGRAM STEP 83 When the machine enters step 83 press the START PROCESS switch The machine will then enter step 84 and after a ten minute hold time will proceed to PROGRAM STEP 97 The SANITIZE COMPLETE message will reappear 19 Your Renatron PA 100 Series station is now ready for normal use Note Formula 409 is a registered trademark of the Clorox Co Oakland CA International Distributors should contact your Minntech Renal Systems Distributor to obtain this product if not available locally D Storage When Not In Use The Renatron PA 100 Series station should be stored in a protected location Avoid high traffic areas wherethe machine might get damaged and avoid high humidi
25. ap on the dialysate inlet port of the dialyzer G Suggested Cleaning of the Dialyzer Case 1 Wipethe entire capped reprocessed dialyzer with a disposable wipe soaked in fresh 196 Renalin 100 Solution or full strength Actril solution 2 Discard the disposable wipe 3 Rinse off the solution from the dialyzer case with cold flowing pure water and dry H Suggested Dialyzer Identification and Documentation Procedures IMPORTANT NOTE IT IS THE RESPONSIBILITY OF THE PRESCRIBING PHYSICIAN TO DETERMINE WHAT INFORMATION IS RECORDED AND THE MANNER IN WHICH THE RECORDS ARE MAINTAINED 1 Theuse of indelible waterproof or permanent ink or other indelible marking systems to label the dialyzer is recommended 2 Itis recommended that the following information be recorded legibly on each dialyzer a Patient s Identification required b Dialyzer use number required c Datethe dialyzer was last reprocessed required 17 Instruction Manual Storage and Handling for R eprocessed Dialyzers Calibration and Adjustment Renatron PA 100 Series Calibration Procedure Instruction M anual d Pressure leak test results optional e Measured volume of blood compartment test optional f Theinitials of the operator who reprocessed the dialyzer optional g Any other information required by the prescribing physician 3 Itis recommended that a label with the above information be used on every reprocessed dialyzer A
26. be filtered to particle size not larger than 1 micron 4 Temperature must be in a range of 59 F 75 F 15 C 24 C 5 Static no flow pressure should not be in excess of 55 psig 379K Pa 3 79 Bars For optimal performance adjust the pressure to 40 psig 276K Pa 2 76 Bars dynamic output pressure while all Renatron PA 100 Series are operating in step 04 and all the other equipment on the same water system are in operation G Drain Thedrain must be capable of accepting a mini mum water flow of 1 6 gal min approx 6 liters minute per Renatron PA 100 Series station Optimal placement is at counter top level and the drain should be placed no higher than the top of the machine Sanitary drain connections must be used in accordance with state and local plumbing codes Drain must be vented to atmosphere Drain piping should be made from PVC CPVC or other corrosion resistant material s H Dialyzer Testing The Renatron PA 100 Series station performs a blood compartment priming volume measurement and a pressure leak test on each dialyzer 1 Blood Compartment Priming Volume M easurement The Renatron PA 100 Series measures displays and holds each reprocessed dialyzer s blood compartment volume with a repeatability of 5 typically within 5 0 ml of true volume If this volume is less than the blood compartment reference vol ume selected by prescribing physician the dialyzer fails the volume test 2 Pressure Drop T
27. d be cleaned as often as operating conditions require CAUTION ANY LIQUID SPILLED ON THE MACHINE EXTERNAL SURFACES SHOULD BE WIPED OFF IMMEDIATELY TO REDUCE THE POSSIBILITY OF MOISTURE ENTERING THE MAIN CASE ASSEMBLY IF SUCH A CONDITION WERE TO EXIST IT COULD CREATE AN ELECTRICAL CONDUCTIVE PATH WHICH COULD RESULT IN INSTRUMENT FAILURE CAUTION DO NOT USE CHEMICAL CLEANING AGENTS THAT COULD DAMAGE THE PLASTICS USED IN THIS MACHINE AVOID CHEMICALS WHICH CONTAIN ALCOHOL BENZENE TOLUENE XYLENE ACETONE OR OTHER AROMATIC OR KETONE SOLVENTS DO NOT USE BLEACH C Formula 409 Service Cleaning Procedure The internal fluid pathways must be cleaned periodically typically every 2 weeks as outlined below Renatron PA 100 Series machines experience deposits which gradually build up inside the blood lines with continued machine use The amount of build up is proportional to the extent of machine use the number of dialyzers reprocessed and such factors as heparin regime and rinseback method This build up is a waxy denatured substance with a slight yellow tint If the build up is allowed to continue the machine may give erroneous blood volume readings low and may stop operating altogether Before this substance becomes visually evident in the blood lines the procedure outlined below should be performed to remove the deposits CAUTION THIS PROCEDURE CALLS FOR THE USE OF FORMULA 409 CLEANER DEGREASER THIS LIQUID CHEMICAL IS AN EYE
28. d the purchaser accepts the products subject to all the terms hereof Any product returned to Minntech Renal Systems for replacement becomes the property of Minntech Renal Systems 23 Warranties Limitations Instruction Manual Explanation for Symbols Attention consult accompanying documents Off power disconnected from the mains On power connected to the mains Off connected to mains but in a wait or standby mode On active state as opposed to standby AN Dangerous voltages within equipment IPX1 Drip proof equipment As Operator Accessible Fuse Location Technical Service Centers U S Service Locations International Service Locations Minntech Corporation Minntech B V Singapore Representative Office 14605 28th Avenue North Sourethweg 11 59A Duxton Road Minneapolis MN 55447 U S A 6422PC Heerlen Singapore 089523 Tel 763 553 3300 The Netherl ands Tel 65 227 9698 Toll Free 800 328 3340 Tel 31 45 5471471 Fax 65 225 6848 Fax 763 553 3387 Fax 31 45 5429695 Note Parts service and a service manual with drawings parts lists circuit diagrams are available on request from M inntech s Customer Service department Instruction M anual 24 Part Number Listings Item Part Number Renalin 100 Cold Sterilant 50090 720 Instructions for Use Perassay 500 Directions for Use 50086 010 Renalin Residual Test Strips 50083 000 Directions for Use Renatron PA Service Manual 501
29. d with fresh 1 Renalin 100 Solution or full strength Actril solution Discard the used wipe 2 Verify that the Calibration Cell is attached to the Renatron PA 100 Series Station 3 Turn on the water supply and check static water pressure reading Should be between 20 55 psi 138 379K Pa 1 38 3 79 Bars 4 Verify that there is sufficient Renalin 100 in the container to reprocess the dialyzer that will be installed on the Renatron PA 100 Series station in step D below and that the Renalin 100 is not expired Approximately 1 2 5 cm of Renalin 100 is required Verify that the uptake hose is connected to the container 5 Touch the ON switch and select program mode 00 a To change the program mode simultaneously press MUTE ALARM and RESET b START PROCESS will not initiate if SEL is displayed in the upper window To clear press HOLD TO SET and turn SET knob to 255 6 Check dynamic water pressure In step 4 the dynamic pressure should optimally be between 30 35 psi 2 07 2 41K Pa 2 07 2 41 Bars 7 Verify that the Calibration Cell volume displayed is within 3 ml of the recorded reference volume 8 Mutethe audible alarm 9 Removethe Calibration Cell 10 Press RESET C Remove the Dialyzer from the Extracorporeal Blood Circuit using standard facility protocols Note Prior to removing the dialyzer from the extracorporeal circuit the operator must ensure that all identification and in
30. e reprocessed to 80 of the new dialyzer priming volume New dialyzer measured priming volume may differ from advertised volume by as much as 20 It is recommended that the operator measure new dialyzer volume with a known calibrated Renatron PA 100 Series to determine actual new dialyzer priming volume 2 Automatic Reprocessi ng Steps a After the START PROCESS switch is pressed to initiate the reprocessing cycle the Renatron PA 100 Series will reprocess the dialyzer according to the steps outlined in the appropriate Operation Format and Program Outline document as follows Document Code Program Kuf Time OO Low Flux Dialyzer 8 min CH Mid Range High Efficiency and 8 15 8 min Hemophan Type Dialyzers High Range High Flux HF dialyzers and Hemofilters NOTE The Renatror PA 100 Series machine should be sanitized a minimum of ONCE PER DAY 50098 000 50098 001 50098 002 3 Themachine can automatically sanitize itself when the Volume display indicates SEL and program mode 00 CH or HF are displayed in the PROGRAM STEP display The operator touches the START SANITIZE switch to start the sanitize cycle The steps of the sanitize cycle are given below a Operator first visually verifies that the RENALIN 100 SOLUTION SUPPLY TANK has at least one inch of unexpired Renalin 100 Solution remaining in the tank NOTE If an insufficient amount of solution exists to c
31. each day ensure that the Renalin 100 has not passed the expiration date marked on the Renalin 100 container NOTE Thesupply tank will hold sufficient Renalin 100 to clean approximately 250 280 dialyzers low flux and mid range programs or 180 200 dialyzers high flux program 4 Priorto the removal of the dialyzer from the blood circuit the operator must ascertain that all identification and information on the dialyzer is legible and current See Dialyzer Identification and Documentati on Procedure on page 17 Instruction M anual 14 5 After storage and prior to preparation for use a sample of fluid should be removed from the dialyzer and tested for the presence of Renalin 100 using the Renalin 100 presence test procedure and Perassay 500 Peracetic Acid Indicator Test Strips Part 78378 or Renalin Indicator Test Strips Part 78199 The Renalin 100 presence test procedure is described in the Renalin 100 Cold Sterilant Instructions for Use Part 50090 720 WARNING THE PROPORTIONED RENALIN 100 SOLUTION CONTAINED IN THE REPROCESSED DIALY ZER MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO ITS CLINICAL USE THIS SHOULD BE DONE IN ACCORDANCE WITH THE INSTRUCTIONS SET FORTH IN THE RENALIN 100 COLD STERILANT INSTRUCTIONS FOR USE PART 50090 720 B Start Up 1 Prior to the first use of day wipe off the front panel of the Renatron PA 100 Series station with a disposable wipe saturate
32. eling If the START PROCESS switch is pressed after entering PROGRAM STEP 83 total sanitize cycle time will be approximately seventeen 17 minutes which includes a 10 minute hold time This will sanitize the machine fluid pathways This cycle will also allow the purging of the Renatron PA 100 Series hydraulic pathways for shipping purposes Use the methods described in c d above for a routine sanatization procedure e Operator wipes clean the external machine surfaces with a lint free disposable towel saturated with fresh 196 Renalin 100 solution or undiluted Actril solution f TheRenatron PA 100 Series is now ready for reprocessing of dialyzers gt Materials of Construction Acrylic PVC ABS Polypropylene Delrin Ethylene Propylene Viton Rubber Stainless Steel B Electrical Leakage Current risk current Each Renatron PA 100 Series 100 micro amps RMS MAX at 115 VAC per CSA Standard C22 2 No 125 Section 6 3 with revisions to 1984 C Electrical Requirements 1 Renatron PA 100 Series station V lfag Selectable 100 120 230 240 VAC ge 50 60 Hz single phase 100 120 VAC one 4A 3AG 1 25 inches x 0 25 inches 220 240 VAC two T2A 5mm x 20mm Equipment Classification Class 1 Electrical Leakage Current From cabinet to ground 100uA risk current From ground wire to outlet 100uA Power Consumption 460 VA maximum Mode of operation Continuous operation D Physical Prop
33. erties and Dimensions 1 Renatron 100 Series stati on Width 14 5 inches ees em 2 Drip Tray Version 1 Version 2 single dual 15 25 inches 33 25 inches 28 inches 28 inches 3 5 inches 3 5 inches Weight 3 Ibs 1 36 kg 6 Ibs 2 73 kg E Environmental Limits The Renatron PA 100 Series is designed to be safe for indoor use at temperatures from 5 C 41 F to 40 C 104 F maximum relative humidity of 80 at 31 C 87 8 F decreasing linearly to 50 relative humidity at 40 C 104 F and altitudes up to 6500 ft 2000 meters The supply line voltage fluctuations may not exceed 10 of the nominal voltage F Water Requirements 1 Flow a Feed line flow 0 46 gallons per minute 1 75 liters minute average pressure at 20 55 psig 137 9 379 K Pa 1 38 3 79 Bars per Renatron PA 100 Series station b Peak flow rateis approximately 1 6 gallons per minute 6 liters minute per Renatron PA 100 Series station This peak flow is 15 35 seconds in duration and occurs at approximate three 3 minute intervals 2 Water must meet quality requirements listed in the current versions of the ANSI AAMI Standard for Hemodialysis Systems and ANSI AAMI Recommended Practice for Reuse of Hemodialyzers It must meet both endotoxin and bacterial specifications listed in the current version of the ANSI AAMI Recommended Practice for Reuse of Hemodial yzers 3 Inlet water must
34. est The dialysate compartment of each dialyzer is subjected to 250 mmHg negative pressure while the blood compartment remains at atmospheric pressure A dialyzer that loses pressure at a rate equal to or greater than 0 83 mmHg 10 per second fails the pressure leak test low flux 00 and mid range CH programs A dialyzer that loses pressure at a rate equal to or greater than 1 25 mmHg 10 per second fails the test for the high flux HF program 9 Instruction Manual Description of Controls Instruction M anual Chemicals Required This Renatron PA 100 Series station is designed to function with Renalin 100 Cold Sterilant solutions These solutions are described in the Renalin 100 Cold Sterilant Instructions for Use P N 50090 720 A Renatron PA 100 Series Station Controls 1 OFF switch de energizes electronic circuitry in the Renatron PA 100 Series POWER WILL STILL BE TRANSMITTED TO THE MACHINE UNLESS THE MACHINE IS DISCONNECTED FROM THE ELECTRICAL POWER SUPPLY 2 switch energizes electronic circuitry Sets Renatron PA 100 Series station in standby mode i e vol ume display reads SEL and PROGRAM step display indicates 3 START PROCESS switch initiates dial yzer reprocessing only when a priming volume has been set and a dialyzer reprocessing program selected i e 00 CH Note START PROCESS also allows user to repeat most program steps after an alarm situation
35. formation on the dialyzer is legible and current before proceeding WARNING THE OPERATOR SHOULD WEAR PROTECTIVE EYEWEAR RUBBER GLOVES AND OTHER PROTECTIVE CLOTHING FOLLOW UNI VERSAL SAFETY PRECAUTIONS FOR DEALING WITH BLOOD CONTAMINATED DEVICES CAUTION THE TIME INTERVAL BETWEEN REMOVING AND REPROCESSING THE DIALY ZER SHOULD KEPT WITHIN THE LIMITS PRESCRIBED BY THE PHYSICIAN THE SUGGESTED MAXIMUM TIME INTERVAL IS TWO 2 HOURS D Installation of the Dialyzer on the Renatron PA 100 Series station 1 Removethe blood port cap from the venous blood port of the dialyzer Wipethe venous blood port with a wipe saturated with 196 Renalin 100 Solution 2 3 Attach the Renatron PA 100 Series venous outlet lineto the venous port of the dialyzer 4 Connectthe dialyzer dialysate inlet to the Renatron PA 100 Series dialysate inlet 5 Connect the dial yzer dialysate outlet to the Renatron PA 100 Series dialysate outlet sanitize interlock 15 Instruction Manual Instruction M anual 6 Remove the blood port cap from the arterial blood port 7 Wipe the arterial blood port with a wipe saturated in 1 Renalin 100 Solution 8 Attach the Renatron PA 100 Series arterial inlet line to the arterial blood port of the dialyzer Dial yzer placement should be vertical to the Renatron PA 100 Series CAUTION IT ISTHE SOLE RESPONSIBILITY OF THE PRESCRIBING PHYSICIAN TO DETERMINE THE BLOOD COMPARTMENT REFERENCE VOLUME AND PROG
36. in Section 6 C of this manual 6 When the PROCESS COMPLETE message appears the reprocessed dialyzer is ready to be removed from the Renatron PA 100 Series station 7 If a VOLUME FAIL or PRESSURE FAIL message appears press the START PROCESS switch to repeat the test which was failed The dialyzer may pass the test when retested by the Renatron PA 100 Series Note Pushing START PROCESS after a VOLUME FAIL alarm will cause the machine to attempt to draw additional fluid from the blood compartment for measurement If additional fluid is obtained the total volume drawn may now be enough to allow a dialyzer that was only a few ml below the minimum acceptable volume to pass the volume test Multiple attempts to draw additional fluid from the dialyzer have not proved to be effective at improving the likelihood of passing the volume test 8 Ifthe dialyzer fails either the pressure test or the volume test discontinue use of the dialyzer F Removal of the dialyzer from the Renatron PA 100 Series station CAUTION CAREFUL ASEPTIC TECHNIQUE MUST BE FOLLOWED WHILE REMOVING THE REPROCESSED DIALY ZER FROM THE RENATRON 100 SERIES TO PREVENT CONTAMINATION OF THE DIALY ZER BLOOD PATHWAY CAUTION DIALYZERS REPROCESSED WITH PROPORTIONED RENALIN 100 SOLUTION MAY UNDERGO AN INTERNAL PRESSURE BUILDUP DURING STORAGE THEREFORE USE MINNTECH RENAL SYSTEMS DIALYSATE PORT CAPS ONLY 1 Assure a supply of disinfected port caps Disinfect
37. ion of the dialysate port and bl ood port caps from the dialyzer can be achieved by one of the following ways a Place the caps to be disinfected into fresh 196 Renalin 100 Solution for a minimum of 30 minutes b Place the caps to be disinfected in full strength Actril solution a minimum of 30 minutes 16 CAUTION MINNTECH RENAL SYSTEMS DIALYSATE PORT CAPS AND DIALY ZER BLOOD PORT CAPS ARE NOT AUTOCLAVABLE 2 Wear protective clothing as indicated in the Renalin 100 Cold Sterilant Directions for Use Part 50090 720 and the Material Safety Data Sheet MSDS for Renalin 100 Cold Sterilant Note Remove the dialyzer from the Renatron PA 100 Series ONLY when the PROCESS COMPLETE message is displayed or when the dialyzer has failed the volume or pressure test If the dialyzer has failed the volume or pressure test it must be either retested press START PROCESS switch recleaned touch RESET and then START PROCESS switch or removed and discarded When the PROCESS COMPLETE message is displayed automatic venting of any pressure buildup in the dialyzer or machine will occur Press RESET before removal of the dialyzer 3 Disconnect the ARTERIAL INLET line from the dialyzer Wipe end of line with gauze saturated with 1 Renalin 100 Solution or full strength Actril solution Reconnect the end of this line to its SANITIZE ARTERIAL connector located on the machine front panel 4 Wipe the external surf
38. lay and will appear in the PROGRAM STEP display window Push the MUTE switch and the RESET switch at same time 00 will be displayed in the PROGRAM STEP display window Touch and hold the HOLD TO SET switch and adjust the SET knob until the VOLUME window displays 003 Release the HOLD TO SET switch Press the START PROCESS switch The machine will finish the process cycle and then the PROCESS COMPLETE message and tone will be activated The calibration cell volume recorded in Step H above should be within 3 cc of the volume value displayed on the Renatron PA 100 Series If the valueis not within this range refer to the Calibration and Adjustment Section of this manual Press the RESET switch The VOLUME display will read SEL and the PROGRAM STEP display will indicate 00 or the last program mode used Press the START SANITIZE switch A red light will appear in corner of switch Ensure that the machine completes all sanitize steps and stops at step 83 After the START PROCESS switch is pressed the machine should complete the cycle after approxi matel seventeen 17 minutes Steps higher than 83 are used only when a complete hydraulic purge is needed e g preparation for shipment Installation is complete Repeat for each Renatron PA 100 Series station 13 Instruction Manual CAUTION RENATRON PA 100 SERIES STATIONS ARE NOT SANITIZED AT THE FACTORY SANITIZE PROCEDURE
39. n 17 minutes which includes a 10 minute hold time This will sanitize the machine fluid pathways This cycle will also allow the purging of the Renatron PA 100 Series hydraulic pathways for shipping purposes 8 Turn off water supply to the Renatron PA 100 Series station 9 If the Renatron PA 100 Series station is not used within 7 days time after sanitize is complete it should be sanitized again and allowed to sit for at least 6 hours prior to use Operating Procedures A General Considerations and Cautions CAUTION MINNTECH RENAL SYSTEMS STRONGLY RECOMMENDS THAT ANY HOLLOW FIBER DIALY ZER REPROCESSED BY THIS MACHINE ACCORDING TO THE INSTRUCTIONS IN THIS MANUAL BE USED ONLY BY THE PATIENT WHO ORIGINALLY USED THE DIALYZER 1 When the Renatron PA 100 Series station is not in use the ARTERIAL INLET and VENOUS OUTLET lines should be connected to the Calibrated Volume Cell The DIALYSATE INLET line should remain attached to the male male fitting on the DIALY SATE OUTLET SANITIZE INTERLOCK connector 2 Atthe end of each day the operator should sanitize each Renatron PA 100 Series station The SANITIZE cycle sanitizes the machine and prepares it for overnight storage 3 Renalin 100 Cold Sterilant and its diluted versions are light sensitive The Renalin 100 Cold Sterilant storage carton can be used to hold the Renalin 100 containers and reduce thelight exposure of Renalin 100 Before using the Renatron PA 100 Series
40. omplete one full SANITIZE cycle the machine will automatically alarm The message ADD CHEMICAL will appear on the front panel and remain visible until the alarm situation has been corrected and the START SANITIZE switch has been pressed b Operator connects the system s ARTERIAL INLET and VENOUS OUTLET lines to the calibration cell or their respective SANITIZE ARTERIAL and SANITIZE VENOUS connectors and connects the DIALYSATE INLET line to the DIALY SATE OUTLET SANITIZE INTERLOCK connector using the male male fitting attached to the front of the machine 7 Instruction Manual Specifications Instruction M anual c Operator touches the ON switch selects a program by pressing the MUTE and RESET switches then touches the START SANITIZE switch which activates the sanitize cycle The machine will automatically fill and flush all internal blood contact surfaces and the dialysate circuit with Proporti oned Renalin 100 Solution The machine then enters PROGRAM STEP 83 at which time the SANITIZE message will be displayed and a 3 second continuous tone will sound d Operator presses OFF switch and allows machine to sit for a minimum of six hours before usingto reprocess dialyzers NOTE A sanitize holding period of six hours or more will expose the machine s fluid pathways to Proportioned Renalin 100 Solution for a time consistent with the disinfection time indicated in the Renalin 100 Cold Sterilant lab
41. tem Operation The Renatron PA 100 Series is an automated system for rinsing cleaning and testing of hollow fiber dialyzers and for delivery of Proportioned Renalin 100 Cold Sterilant solution to the dialyzers After rinsing and cleaning the dial yzers the Renatron PA 100 Series compares the blood compartment filling volume priming volume against the predetermined volume set into the machine The machine also conducts pressure eak tests on the bl ood and dialysate compartments of the dialyzer If either the blood compartment volume test or the pressure leak test is unsatisfactory the machine will automatically stop functioning and activate audible and visual alarms The Renatron PA 100 Series stations use Renalin 100 Cold Sterilant as the only chemical needed to reprocess dialyzers THE QUALITY OF WATER USED TO SUPPLY RENATRON PA 100 SERIES STATIONS MUST EQUAL OR EXCEED REQUIREMENTS LISTED IN THE SPECIFICATIONS SECTION The Renalin 100 Cold Steril ant used by the Renatron PA 100 Series can cause a pressure build up within the machine and or the dialyzer under certain conditions To prevent this possible pressure build up the Renatron PA 100 Series will automatically perform a venting operation every 10 seconds after fillingthe dialyzer with Proportioned Renalin 100 Solution CAUTION IN THE EVENT A DIALYZER HAS BEEN LEFT ON THE MACHINE AND DOUBT EXISTS WHETHER VENT ACTION HAS OCCURRED I E POWER FAILURE TO RENATRON PA 100 S
42. ty The Renatron PA 100 Series station is a high quality precision medical system and should be treated as such The system has been designed to withstand the rigors of normal use and with reasonable care and maintenance should provide many hours of trouble free operation Minntech Renal Systems maintains a special repair and calibration facility to provide its customers with expert service for its products If your Renatron PA 100 Series system requires servici ng we recommend that you contact your Minntech Renal Systems Distributor Note Pressing the START PROCESS switch while Renatron PA 100 Series is turned on and is holding in Step 83 will result in a 10 minute hold in Step 84 with subsequent water rinse and air purge of hydraulic pathway This second series of sanitize steps 84 97 are intended for use ONLY when removal of fluid in hydraulic pathway is necessary i e prior to shipment or transport of Renatron PA 100 Series station or long term storage of the Renatron PA 100 Series unit CAUTION ALL CHEMICALS SHOULD BE THOROUGHLY RINSED FROM UPTAKE LINES BEFORE REPACKING RENATRON PA 100 SERIES STATION CAUTION PERFORM A COMPLETE SANITIZE CYCLE AS DESCRIBED IN THE NOTE ABOVE BEFORE REPACKING RENATRON PA 100 SERIES THIS ACTION ENSURES NO FLUID WILL REMAIN IN HYDRAULIC SECTION IF FLUID REMAINS IN THIS SECTION IT MAY FREEZE AND CAUSE DAMAGE TO HYDRAULIC COMPONENTS A Repacking Before repacking the Renatron PA
43. witch and repeat procedure steps c and d above This action clears the water from the uptake hose and replaces it with Formula 409 9 Press select program 00 press the START SANITIZE and DISPLAY switches Allow the machine to continue operating to the SANITIZE COMPLETE message in PROGRAM STEP 83 10 Press the OFF switch and turn the water supply to the machine off Leavethe machine overnight Wait at least 8 hours 11 Remove the uptake tube from the container of Formula 409 and make sure any excess Formula 409 drains from tube back into container Place the uptake tube in a container of pure water one gallon or more Turn the water supply on 21 Instruction Manual Service Instruction M anual 12 Press ON select program 00 press the START SANITIZE and DISPLAY switches Allow the machine to operate to completion of PROGRAM STEP 75 and press the OFF switch No problems will occur if machine operates past step 75 before turning off This action clears the Formula 409 from the uptake hose and replaces it with water 13 Press ON select program 00 press the START SANITIZE and DISPLAY switches Allow the machine to operate to PROGRAM STEP 83 and when machine enters step 83 press the START PROCESS switch The machine will then enter step 84 and after a ten minute hold period in step 84 will proceed with flushing and draining The flushing and draining will continue until m
44. xi ng measuring tank should be empty but is not or when an improper action has occurred within the tank 4 CLEAN message appears duri ng the dialyzer cleaning steps 5 ADD CHEMICAL error message appears when machine detects that insufficient amount of Renalin 100 solution has been drawn into the mixing measuring tank 6 TEST message appears during the dialyzer testing steps 7 VOLUME FAIL error message appears when measured dialyzer blood compartment priming volume is less than the blood compartment reference vol ume 8 PRESSURE FAIL error message appears when a fiber leak has been detected by the machine 10 ARITERIAL OUTLET SANITIZE INTER CCK SANTOS BAANITIZE VEMCUE DIALYSATE INLET VENOUS CLITLET 11 Renatron PA 100 Series Upgrade WARNING Use of germicide s other than RENALIN 100 COLD STERILANT CONCENTRATE may result in Improper dilution of the germicide Asafety hazard Adverse performance Decreased component life and machine reliability 67197 8918 TEST eee EH AGNUSTICS Instruction Manual Renatron PA 100 Series Installation Instructions Instruction M anual 9 DISINFECT message appears during the dialyzer disinfection steps 10 ALARM error message flashes continuously until alarm condition is corrected 11 PROCESS COMPLETE message appears when dialyzer reprocessing cycle is complete
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