Endosafe®-MCS™ User's Guide for Endotoxin (LAL) Testing, Gram
Contents
1. MCS Service Programs WARRANTY with PURCHASE Chares River Laboratones warrants the Endosafe MCS instrument wil be delivered in a functonal state and tres from defect and wil mest stated specificaticns for a period of one 1 year The warranty period wil start on ine date of shipment by Charles River Laboratorios During the warranty pers hares River Laboratories wil repair the instrument at no charge to tha cant for parts and labor If repairs are needed Charles River Estoratoces wil provide ine cent a loaner instrument during tne period the instrument is baing repaired The cient shall be responsible for al freight charges associated wih the retume instrument and te loaner instrument Opening the case ar tampering with the interior components of the reader wil invalidate warranty provisions Additonal service contracts are avasabl as follows ELA a Peromance Ouacaien PO Serie 15502 13 00 Pa Package MESIE OnT Raai MCSE Pues PIMCSI01 03 ON DEMAND REPAIRS After the inal Warranty Period has ended the cont may request Charles River Laboratories to service or repair the MCS Charles River Laboratories wil arrange transfer of the MCS instrument to the Company s Technical Services Laboratory and provide the clienta loaner instrument during the period On Demand repairs are being made See Returned Goods Authorization Procedure below The cient shal be responsible for al freight charges2. Page C2 PIMCS101 03 TEST RESULTS 14 When the test is complete the MCS Reader gives an audible notification thatthe assay is finished 2 At the conclusion ofthe test the assay acceptance criteria aro displayed on the screen 3 The software displays the following results Spike 1 Recovery Spike 2 Recovery Spike 3 Recovery Spike 4 Recovery When the test is complete the results will be displayed on the screen The software continues to display the assay results unl the naw assay button is selected Page C3 PIMCS101 03 Appendix D Endosafe MCS Rapid Micro Methods Glucan PERFORMING ROUTINE GLUCAN TEST The PTS Glucan assay is used for the detection of 1 3 8 D Glucans The Endosafe MCS Glucan assay is intended for research purposes oniy and is not to be used for diagnostic testing purposes A routine MCS Glucan assay is conducted by following the simple prompts on the EndoScan V software The following represents a typical assay procedure 1 Instrument Operation Open the EndoScan V software Verify the screen contains a panel for each bay ofthe instrument 2 Insert the Cartridge Remove cartridge from pouch and insert with sample reservoirs facing up into siot at ront of the MCS Reader Press cartridge frmy into slot Note Allow the cartridge t come to room temperature in pouch before 3 Enter Required Information Once the cartridge has been firmiy inserted into the reader the software pr
3. 005 EUmI range ses Appendix A Rapid Micro Methods Gram ID Archived parameters for Gram negative Gram postive and YeastiMold jeolateidenestion see Appendix B Intibifion Enhancement Screening see Appendix C Rapid Micro Methods Glucan see Append D Acceptable temperature 37 C2 1C Sample requirement 25 ul sample per channel NOTE Sampie must be delvered to each sample port without contamination or cross contamination Between samples Endosafe PTS Accessory Products Product Description code PC Cable Standard USB cable Type A PTSI08 and Type B Endosate MOS mini pipator 254L disposable uni wi 5 PTS400 accuracy and 3 precision at f stroke Espendor pipette tips 200 v individual wrapped D100 aidata to 0 005 Ulm Multiple patents pending PIMCS101 03 Endosafe MCS Reader Environmental Requirements Surface fiat level surface vibration tree Surroundings free hom dist solvents and acidics vapours and out of direct sunight Operating Temperature 15 io 27 C Humidity 5 to 20 noncondensing Endosafe MCS Reader Installation The MCS reader comes as a ready to use device so no further installations onthe hardware are necessary Simply connect the MCS reader to the computer with the provided USE cable The Type E connector goes fo the reader and tne Type A connector to the PC Provida the MCS reader with power by connecting
4. 7016 or 843 768 7575 Europe 00800 15 7897 43 Fax 843 766 7576 EMail lendo comments er com Page 13 PIMCS101 03 Appendix A Endosafe MCS Endotoxin PERFORMING ROUTINE TEST A routine MCS LAL assay is conducted by following the setup procedure The following represents atypical assay procedure 1 Instrument Operation Open the EndoScan V software Verify the screen contains a panel for each bay of the instrument 2 Insert the Cartridge Note Allow the cartridge to come lo room temperature in pouch before Remove cartridge from pouch and insert with sample Feservoirs facing up into one ofthe siots at front of the MOS Reader Press cartridge frmy into slot 3 Enter Required Information Once the cartridge has been fimiy inserted into the reader the software prompts the user to enter the following information Enter Cartridge Lot Enter Calibration Code f the Calibration Code for the particular lot has already been entered the sofware automatically Inputs this information unti the lot numbers and calibration codes are erased by the user Enter Product Enter a sample ID or drag and drop information from the database Enter Product Low Enter Dilution Factor or Concentration Select the Send Setup box on the screen to transfer the product Information to the MCS Reader Noto All LAL Reagent Water LRW used to make product dilutions shouid be tested for the absence of detectable endotox
5. sample IDs by a semi colon Enter Product Lote Separate product Lots by a semi colon Enter Dilution Factor Select the Send Setup box on the screen to transfer the product Information to the MCS Reader Note AILA Reagent Water LAW used to make product dilutions should be tested for the absence of detectable endotoxin Mila the above information is being entered Into the reader the cartridge is being pre warmed A Dispense the Sample Once all test information is entered the software displays Add Sample and click Start 1 Pipette 25 uL of sample into al four 4 sample reservoirs of the inserted cartridge and select the start assay button on the panel Pumps draw sample aliquots into the test channels thereby initiating the test Results wil be obtained in approximately 7 minutes for Gram negative Gram positive and Yeast Mold identification and 3 minutes for Gram negative and Gram positive identification Page B2 PIMCSI01 03 GRAM ID TEST RESULTS 41 When the test is complete the result wil bo displayed on bay screen as and YIM 2 At the conclusion of the test the gram identification is displayed on the Screen for each sample as Gram Negative Gram Positive Yeast Mold The software continues to display the assay results until the new assay button is selected RETRIEVING RESULTS OPTIONS 1 Select Report from the fle menu or the printer icon from the toolbar The assay re
6. The Endosafe MCS Multi Cartridge System USER S GUIDE Table of Contents Safety Guidelines Endosafe MCS System Overview Reader Specifications Cartridge Specificati Accessory Products Environmental Requirements Installatio Controls and Signals Endosafe MCS Warranty with Purchase On Demand Repairs Returned Goods Authorization Procedure Warranty Registration Using EndoScan V with Endosafe MCS for data acqui Troubleshooting Service Programs PIMCS101 03 Appendixes Appendix A Performing Routine Endotoxin Test Retrieving Results Options Appendix B Performing Routine Gram ID Test Gram ID Test Results Retrieving Results Options Appendix Performing Inhibition Enbancement Test Test Results Appendix D Performing Routine Glucan Test Glucan Test Results Retrieving Results Options Appendix E Abbreviations Used Appendix F Decontamination Procedures PIMCS101 03 BRE BI B3 B3 a ry DI Dm Dm El Fl SAFETY FIRST WARNING DO NOT use an AC power cord other than that which has been delivered with Your system Only plug the cord into a socket which is grounded Using a Loren cord may cause fra leading to serious injury DO NOT place MCS system around any Iquid or use in a location whore it could get wet or splashed Liquids could cause fira a electric shock IF the equipment is used in a manner not speci by the manufacturer the protectio
7. ana Eten Power cable Users Guide e E AE a Pack 0 05 Elm senstvty prs2005F 10 cartridges per package 001 EUmL sens PTS2001F 0 005 Eum sensitvty pTS20005F EndosataUnicensed Cartage 04 EU ME serati PTS201 Was ES ODS Euimi sensawty pTS2005 10 cartridges per package gt OOYEUIML senstiviy PTS2001 Endara PTS Taner Enhancement TSE pack Tnmibtion Enhancement Sersening Screening Cartridge Pack 10 cartrigges per package Endosate PTS RWM oan D 0D TURNO pack Carnage O carriages per package Endosata PTS RMM Gucan _ 3 gt D Glucan RIMOSTONO pac Cartridge 10 cartes per package PIMCSI01 03 Endosafe MCS Reader Specifications Temperatura contol 37 C 21 C Data nterface USB port Printer support Windows supported printer Data storage Files are stored on PC Dimensions 375mm D x 370mm W x 105mm H Power supply unit 100 230VAC SO SOH 1 75 A max Power supply on board 12 V DC SA Fuse 2x T2 SAIL 250V Sx20mm Warm up ime Approximately 5 10 minutes trom 20 C start Display Computer Monitor Environmental Conditions gt Operating Temperature 15 to 27 O Humidity 5 to 80 nancondensing Indoor use 2 Aude normal environmental conditons Weight 83 4g Page PIMCS101 03 Endosafe MCS Cartridge Specifications Reference package insert for storage requirements Endotoxi n Sensitivity 10 0 1 EUimL rango 5 05 EUImL range 1 01 EUIML range 0 5 0
8. associated with the relumed instrument and the loaner Instrument RETURNED GOODS AUTHORIZATION PROCEDURE The lent must obtain a Returned Goods Authorization Number from Charles River Laboratories before any tems can be shipped to the Technical Services Department Al goods returned for repair preventative maintenance or calibration whether under warranty or not must be properly packed to avoid damage and clearly marked with the RGA number WARRANTY REGISTRATION A Warranty Registration Card is provided in is Users Guido and is also available online at www criver com Submiting the completed card wil permit the Technical Services Department to more efficiently meet each client s needs All warranty and service options are Subject to the Terms and Conditions and procedures specified inthe Service Agreement For answers to questions about any ofthese components for the Endosafe MCS or for additional product information please contact Charles River Laboratories Technical Services Department United States 1023 Wappoo Road Suite 43 8 Charleston SC 20407 Usa 800 762 7016 Europe 008001578974 Pago PIMCSI01 03 Operating the Reader Using EndoScan V with Endosafe MCS for data acquisition 4 Insert the EndoScan V CD into the CD drive 2 Install EndoScan V sofware 3 Upon successful installation and registration of the software select PTSIMCS as the reader type from the reader options dialog box Reader Options P
9. aste pre 4 Once successfully connected to a MCS Reader the following screen will appear This will show all avallable bays for each instrument connected er Assay setup pee ear Page 10 PIMCSi01 03 5 Select Tools Options Calculations and change CV Limit Products and CV Limits Standards to 25 Change Spike recovery range to 50 t0200 6 Enter the Cartridge lot number The Cartridge lot number will be stored for later use 7 Enter the Calibration code The Calibration code will be stored for later uso 8 Enter product information by either typing directly into the box or by dragging information from the product database into the dialog box 9 Enter the concentration or dilution 40 Insert the cartridge into the bay 11 Select the Send Setup button lo send information to the MCS Reader 12 Once the Add sample and Click start message is displayed dispense 25 pL into each well of the test cartridge 13 Repeat steps 5 through 12 for each bay that will be used 14 While in progress the screen will display messages showing the current status Page 11 PIMCSI01 03 poten reine o Y 15 Upon completion of the assay a message will ba displayed instructing the user to remove the cartridge and a screen similar to the one below containg data for the assay willbe displayed 16 Select the report option to print a report for this assay 17 Select the save or save as option to
10. ay button is selected RETRIEVING RESULTS OPTIONS 1 Select Report from the fle menu or the printer icon from the toolbar The assay results wil be shown in a report format 2 Results may be printed to any Windows compatible printer Page D2 PIMCS101 03 Appendix E Abbreviations used in this User s Guide MOS Mult Cartidge Mult Cartidge System LAL Limulus Amebocyte Lysate FDA Food and Drug Administration EU Endotoxin Unit LRW LAL Reagent Water Bay Slot on the face of the MOS corresponding to an individual testing device Page El PIMCS101 03 Appendix F Decontamination Procedures Warning Do not immerse the instrument spray it with guid or use a wet cloth Do not allow the cleaning solution to run into the interior of the instrument IF this happens Contact Charles River Laboratories Technical Service Department Important Tum off and unplug the instrament for all decontamination and cleaning operations Turn off an unplug instrument Moisten a cloth with a mild detergent solution Do not souk the cloth Wipe down all surfaces of the instrument 3 Use a clean dry cloth to dry all wet surfaces Page FL PIMCS101 03
11. he presence af Gram negative and Gram positive in approximately 3 minutes this format does not diferentiate between Gram postie and YeastMoid isolates Reference the Cerificate af Analysis for th esibraton code to be usad for each assay result format Sample Preparation From an isolated culture carefully remove clones frm agar surface and suspend cls in approximataly 2 ma of LPS fee Saine or LRW and adjust to a 05 MaFariand Equivalence Turbidity Standard Nate Do not use cotton tip Swabs el any kind during sample preparation A Instrument Operation Open the EndoScan V software Verify the screen contains a panel for each bay of the instrument 2 Insert the Cartridge Nate Allow the cartridge to come lo room temperature in pouch before Remove cartridge from pouch and insert with sample reservoirs facing up into one ofthe slots at rant of the MCS Reader Press cartridge firmly into slot Page BL PIMCSI01 03 3 Enter Required Information Once the cartridge has been fiiy inserted into the reader the software prompts the user to enter the following information Enter Cartridge Lot Enter Calibration Code the Calibration Code forthe particular lot has already been entered the sofware automaticaly inputs this information unl the fl numbers and calibration codes are erased by the user Enter Product Enter a sample ID or drag and drop information from the database Repeat procedure 3 times and separate
12. in While the above information is being entered into the reader the cartridge is being pre warmed Page Al PIMCS101 03 4 Dispense the Sample Once all test information is entered the software displays Add Sample and click Start Pipette 25 pL of sample into all four 4 sample reservoirs of the inserted cartridge and select the star assay button on the panel Pumps draw sample aliquots into the test channels thereby initiating the lest Results wil be obtained in approximately 15 minutes TEST RESULTS A When the test is complete the results will be displayed on screen The software continues to display the assay results unl the naw assay Button is selected RETRIEVING RESULTS OPTIONS 1 Select Report from the fle men or the printericon from the toolbar The assay results will be shown in a report format 2 Results may be printed 16 any Windows compatible printer Page A2 PIMCS101 03 Appendix B Endosafe MCS Rapid Micro Methods Gram ID PERFORMING ROUTINE GRAM ID TEST A routine Gram ID assay is conducted by preparing a bacterial suspension and folowing the emp prompt an De EndoScan V software The folowing representa a pies assay procedure The MCS Gram ID offers two 2 assay report formats One assay resul format wil report the presence of esper Gram negative microorganismo VeastiMold or Gram positive microorganisms in approximateiy 7 minutes The second assay result format wil rapor t
13. n provided by the equipment may be impaired caution DO NOT open the instrument and tamper withthe interior components It do not contain any parts that can be maintained repard or replaced by the user Daing so may cause fire or electric shock DO NOT allow liquids to spil into the carrdga chamber Doing so may damage interior components and may cause fire or elec shock DO NOT unplug AC poer card of PC cable by puling cordicable directly Doing so may damage cord and cause injury Handie tne AC power cord and Serial Port Connector recty lo uniu Read this User s Guide caretully before using the Endosafe MCS System Understanding the proper usage and operation is imperative or the safety of the User as well as the protection of the Endosate MOS System Page PIMCS101 03 Endosafe MCS System Overview The Endosafe MCS Muti Cartridge System is a rapid test system which is comprised of a test cartridge along with a spectrophotometer The Endosafe MCS Endotoxin test utzes existing FDA ioensed LAL formulations The MCS provides quanttatve LAL test results in approximately 15 minutes see Appendix A for testing procedures and test results Al components required for te ng samples wih the MOS are listed below Product Description Catalog 5 Quanity Endasate MOS Kt cea oe Each Reader and Integrated sofware Mul Carr Mul Integrated power supply Da
14. ompts the user to enter the folowing information Enter Lot Cartridge Lot Enter Calibration Code lt tne Calibration Code for the particular lot has already been entered the sofware automaticaly inputs this information unti the lot numbers and calibration codes are erased by the user Enter Product Enter a sample ID or drag and drop information from the database Enter Product Low Enter Dilution Factor or Concentration anual ype paini for the unit of measure Select the Send Setup Box on the screen to transfer the product Information to the MCS Reader Page DI PIMCS101 03 Note All LAL Reagent Water LRW used to make product dilutions should be tested for the absence of detectable endotoxin and glucan While the above information is being entered into the reader the cartridge is being pre warmed sample st information is entered the reader displays ADD SAMPLE and click Start Pipette 25 pL of sample into four 4 sample reservoirs of the inserted cartridge and select the start assay button on the panel Pumps draw sample aliquots into the test channels thereby initiating the lost Results wil be obtained in approximately 30 minutes GLUCAN TEST RESULTS 1 When the test is complete the MCS Reader gives an audible notification hat the assay is finished and the results wil be displayed on the screen The software continues to display th asSay results unl the new ass
15. save the assay as an EndoScan V file 18 The screen will display a message asking to save an individual assay or all assays that have been completed 19 Select the desired method 20 Assay is now saved as an EndoScan V fle Page 12 PIMCSi01 03 Troubleshooting Listed in the table below are various Error or Fault Messages and a description of the corresponding cause of the error or fault gt One or more LONG audible tones wil precede each error message gt Any fault isted here wil prevent the reader from running a test gt Unless itis a hardware problem the only way to clear an errar message is to turn the reader OFF and back ON again MESSAGE DESCRIPTION PAID SETUP Photo AD setup dd not complete TEMP TOOT arriaga temperatura Ts Too lew TEME TOO HT Cartridge Temperaturas oo high MOTOR NOT HOME Cannot run pump motor CLOCK FAULT Cannot read Real Time Glock Computing Error Divide by O or range error UNKNOWN Any unspoci ed system Tau One oF hare Test EDS out ol spac One ar more ol the LEDS doas not abort Test CANCEL OR ENTER have sufficient intensity to run the test property Sample Nol Seen Tashos during Sample was Hol detected In one oF test more of the optical cells I any ofthese or other problems persists contact Charles River Laboratories Technical Service United States 1023 Wappoo Road Suite 43 B CCharelston SC 29407 USA 800 762
16. sults vil be shown in a report format 2 Results may be printed to any Windows compatible printer Page B3 PIMCS101 03 Appendix C Endosafe MCS Inhibition Enhancement Screen PERFORMING INHIBITION ENHANCEMENT TEST An Inhibtion Enhancement MCS LAL assay is conducted by following the simple Setup procedures Different dilutions of one 1 sample can be placed in each Sample wall to determine the non interfering dilution or diferent samples can be placed in each well of one 1 test cartridge The following represents atypical assay procedure 4 2 Instrument Operation Open the EndoScar V software Verity the screen contain a panel for each bay ofthe instrument Insert the Cartridge Remove cartridge ftom pouch and inser with sample reservoirs facing up into one 1 of the bays at front of the MCS Reader Press cartridge frmy nto slot Note Allow the cartidge come to room temperature in pouch before Enter Required information Onte the cartridge has been frmly inserted into the reader enter the Tallo information into the sofware Enter Lot Cartridge Lot Enter Calibration Code tthe Calibration Code for tho particular lot has already been entered the sofware automaticaly Inputs this information unti the lot numbers and calibration codes are erased by the user Enter Product f esting different products then enter the product information for each channel separated by a semi colon Sample 1 is designa
17. ted as the well on the far lef alter cartridge is inserted into the reader testing the same product in al four 4 channels then itis only necessary o enter the product once Page C1 PIMCSI01 03 EntorProduct Lot 1f testing diferent lts of product then enter lot separated by a semi colon Iftesting the same ot Yin al four 4 channels then itis only necessary to enter the lot once Enter Sample 1 1D Selecting and scrolling with the menu key under the sample ID Header allows for fity 50 samples to be entered and stored Enter Conc Dilution If esting different concentrations or dilutions then enter each concentrationidilution separated by a semi colon For example enter 1 10 100 1000 if testing these dilutions Select the unit of measure using the arrow down button Note All LAL Reagent Water LRW used to make product dilutions should be tested for the absence of detectable endotoxin While the above information is being entered into the reader the arvidge is being prewarmed 4 Dispense the sample Once all test information is entered the software displays ADD SAMPLE and click Start Pipette 25 pL of sample into four 4 sample reservoirs of the inserted cartridge and press the start button Be sure to change tips between each dilution or sample Pumps draw sample aliquots into the test channels thereby initiating the test Results wil be obtained in approximately 15 minutes
18. the provided power cabis to th eriy module ofthe reader and he grounded mains outlet DO NOT USE UNGROUNDED POWER OUTLETS During operaton of he MCS reader the lateral venting slots must not be bio ked Also tha cooing fan in the Back of tne MCS reader must not be Blocked at any ime Pease ensure a 60 mm safety clearance on the teft ight and back side ofthe Instrument Endosafe MCS Reader Controls and Signals Frontside view Lateral Venting Cari ge Carridge Slate Slot Sloe Carazo Carriage Blue Power Sloe Slo ON LED Pages PIMCSI01 03 Side view Back let view Power Eny Module Fuse Holder ONOFF Swich Backetight view Tnnactive Power Connection Red Power ON LED USE Connects Paget be PIMCSI01 03 tor the warm up time you wil notice a short beep for each of the fve 5 cartridge slots lo indicate tat the temperature has reached 37 degrees Celsius The MCS reader is than ready to be operated through EndoScan V Carindges can now be used according to our cartridge package insets Please hold the cartridges as shown below Touch any the handle end of the cartridge curves eages to placa ho cartridge into the raader Pago PIMeSIOLO3 Insert cartridge firmly nto the siot at the font of the reader with the sample reservoirs facing up Endosafe
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