® The Endosafe -PTS™ Portable Test System USER’S GUIDE Version 7 endotoxin and microbial detection 1023 Wappoo Road • Suite 43-B, Charleston, SC 29407 Phone: 843.766.7575 • Fax: 843.766.7576 www.criver.com • endo-comments@crl.
® Endosafe - Portable Test System User’s Guide Table of Contents Safety Guidelines .................................................................................. 1 ® Endosafe - PTS System Overview Reader Specifications .......................................................................... 2 Cartridge Specifications ...................................................................... 3 Accessory Products .............................................................................
® Endosafe - Portable Test System User’s Guide Appendixes Appendix A Performing Routine Endotoxin Test .................................................... A1 Endotoxin Test Results ........................................................................ A2 Retrieving Results Options .................................................................. A3 Appendix B Performing Routine Gram ID Test ...................................................... B1 Gram ID Test Results .................................
® Endosafe - Portable Test System User’s Guide SAFETY FIRST WARNING x DO NOT use an AC power adapter other than that which has been delivered with your system. Only plug the adapter into a socket which is grounded. Using a different adapter may cause fire leading to serious injury. x DO NOT place PTS system or charge battery around any liquids or use in a location where it could get wet or splashed. Liquids could cause fire or electric shock.
® Endosafe - Portable Test System User’s Guide Endosafe®- PTS – System Overview ® The Endosafe - PTS (Portable Test System) is a rapid, point-of-use test system which is comprised of a test cartridge along with a hand-held spectrophotometer. ® The Endosafe - PTS Endotoxin test utilizes existing FDA-licensed LAL formulations. The PTS provides quantitative LAL test results in approximately 15 minutes (see Appendix A for testing procedures and test results).
® Endosafe - Portable Test System User’s Guide x x x x x x x x Dimensions: 9.25” x 4.625” x 2.
® Endosafe - Portable Test System User’s Guide ® Endosafe - PTS Accessory Products Product Description Molded cable for PTS Reader to PC AC Adaptor for the PTS Reader Code PTS108 Seiko DPU-414 Printer Battery powered, rechargeable thermal unit PTS300 Seiko Printer Paper Thermal paper rolls for Seiko DPU-414 Printer Molded cable for PTS Reader to ® Seiko DPU-414 Printer AC powered non-thermal unit PC Cable AC Adaptor ® Seiko Printer Cable Epson TM-U220D Printer Epson Printer Cable Epson Printer Ri
® Endosafe - Portable Test System User’s Guide ® Endosafe - PTS Service Programs WARRANTY with PURCHASE ® Charles River Laboratories warrants the Endosafe - PTS instrument will be delivered in a functional state and free from defect, and will meet stated specifications for a period of one (1) year. The warranty period will start on the date of shipment by Charles River Laboratories.
® Endosafe - Portable Test System User’s Guide Charles River Laboratories will arrange transfer for the PTS instrument to the Company’s technical services laboratory, and provide the client a loaner instrument during the period the instrument is being serviced (See Returned Goods Authorization Procedure below). The client shall be responsible for all freight charges associated with the returned instrument and the loaner instrument.
® Endosafe - Portable Test System User’s Guide Operating the Reader BATTERY INFORMATION The PTS Reader can operate on its own battery power or with the supplied AC power adapter. The AC power adapter also serves as the battery charger for the PTS Reader. The batteries enable the user to operate the PTS Reader onsite without the use of a power cord. The rechargeable lithium-ion batteries are installed at the factory and should be replaced only by the factory.
® Endosafe - Portable Test System User’s Guide If the batteries are to remain unused for extended periods of time, it is recommended that they be stored at a charge level of 30 to 70%; maximizing the overall life of the battery. KEYPAD OPERATION It is important to develop a thorough knowledge of the use of the PTS Reader keypad. Learning proper sequences for data entry will ensure your test procedures are successful, and that all necessary results are displayed at the conclusion of each test.
® Endosafe - Portable Test System User’s Guide NOTE: Once Erase All Records has been selected and confirmed, all records will be erased and irretrievable. If necessary, download desired data to PC, Seiko® DPU-414 Printer, or Epson TM-U220D Printer to store prior to erasing all records (see pages 12-14). #5 – System OFF – Selecting this Main Menu option will turn the PTS reader off. #6 – System Reset – Selecting this Main Menu option will automatically reboot the test system.
® Endosafe - Portable Test System User’s Guide C. EXAMPLE OF KEYPAD OPERATION Setting the Time on the PTS Reader: 1. Turn the instrument on by pressing the MENU key ĺ The PTS Reader displays Insert Cartridge after Systems Self Test 2. Press the MENU key ĺ The PTS Reader displays Main Menu and 1-Enter Test Inf 3. Press MENU two (2) additional times for 3-System Menu, and then press 3 ĺ The PTS Reader displays System Menu and 1- Display Date Time 4. Press 3 to select the Time Menu 5.
® Endosafe - Portable Test System User’s Guide D. MENU SHORTCUTS FOR PTS READER KEYPAD The following Menu Shortcuts diagrams the Menu options and their headings and subheadings. Using the table, you can go directly to any of the available menu fields by pressing the MENU key and the appropriate menu item code number.
® Endosafe - Portable Test System User’s Guide Reader Output Downloading Output to PC using the PTS Logger Software 1. Insert the PTS Logger software CD into your PC and download to PC. 2. Connect Cable – Serial port connection to PC and RJ45 plug into back of PTS Reader (cable is provided with PTS System). 3. Select Connect then choose the com port your PTS Reader is connected to in the Setup communications window. Click on the Connect button to connect to PTS Reader. 4.
® Endosafe - Portable Test System User’s Guide 6. Select Log then View to view data in notepad format. Note: The data will automatically be sent to an unnamed Notepad file within the PTS Logger folder. If this file remains in the PTS Logger folder, the next set of data will be added to the bottom of this file. It is recommended that you either rename the Notepad file and move it to another folder or copy the data into a Word file and delete the notepad file.
® Endosafe - Portable Test System User’s Guide Using EndoScan-V with Endosafe®- PTS for data acquisition. 1. Insert the EndoScan-V CD into the CD drive. 2. Install EndoScan-V software. 3. Upon successful installation and registration of the software select PTS/MCS as the reader type from the reader options dialog box. 4. Once successfully connected to a PTS Reader the following screen will appear. While connected using EndoScan-V keyboard operations of the PTS are disabled.
® Endosafe - Portable Test System User’s Guide 5. Enter the Cartridge lot number. The cartridge lot number will be stored for later use. 6. Enter the Calibration code. The Calibration code will be stored for later use. 7. Enter product information by either typing directly into the box or by dragging information from the product database into the dialog box. 8. Enter the dilution in the form of “1:x mL/mL” or “x units/mL” for concentration. 9. Insert the cartridge. 10.
® Endosafe - Portable Test System User’s Guide 13. Upon completion of the assay, a message will be displayed instructing the user to remove the cartridge and a screen similar to the one below containing data for the assay will be displayed. 14. Select the report option to print a report for this assay. 15. Select the save or save as option to save the assay as an EndoScan-V file if Autoname is not selected. 16. To return the PTS to keypad simply disconnect the serial cable from the rear of the PTS unit.
® Endosafe - Portable Test System User’s Guide Troubleshooting Listed in the table below are various Error or Fault Messages and a description of the corresponding cause of the error or fault. ¾ One or more LONG audible tones will precede each error message. ¾ Any fault listed here will prevent the PTS Reader from running a test. ¾ Unless it is a hardware problem, the only way to clear an error message is to turn the PTS Reader OFF and back ON again.
® Endosafe - Portable Test System User’s Guide Appendix A Endosafe® - PTS Endotoxin PERFORMING ROUTINE ENDOTOXIN TEST A routine PTS LAL assay is conducted by following the simple prompts on the PTS instrument. The following represents a typical assay procedure: 1. Instrument Operation x x x Press the MENU key on the PTS keypad to turn instrument on (Menu 5 turns instrument off). The PTS Reader initiates a “SYSTEM SELF TEST” as it heats up to 37°C – this takes approximately 5 minutes.
® Endosafe - Portable Test System User’s Guide 4. Dispense the Sample Once all test information is entered, the PTS Reader displays: x ADD SAMPLE; PRESS ENTER x Pipette 25 μL of sample into all four (4) sample reservoirs of the inserted cartridge and press Enter on the PTS Reader keypad. x Pumps draw sample aliquots into the test channels, thereby initiating the test. x Results will be obtained in approximately 15 minutes. ENDOTOXIN TEST RESULTS 1.
® Endosafe - Portable Test System User’s Guide RETRIEVING RESULTS OPTIONS 1. You can download results directly to your PC and retrieve from the designated location file. ® 2. You can use the Seiko DPU-414 Printer or the Epson TM-U220D Printer (available from Charles River Laboratories) to print the last test result, all results from a particular date, or up to a maximum of one hundred (100) stored test results. ********* ENDOSAFE Test Record ********* V7.12B 12/9/2008 DateTime: ........
® Endosafe - Portable Test System User’s Guide Appendix B Endosafe® - PTS Rapid Micro Methods Gram ID PERFORMING ROUTINE GRAM ID TEST A routine Gram ID assay is conducted by preparing a bacterial suspension and following the simple prompts on the PTS Instrument. The following represents a typical assay procedure: The PTS Gram ID offers two (2) assay report formats.
® Endosafe - Portable Test System User’s Guide Note: If refrigerated, allow the cartridge to come to room temperature in pouch before use. 3. Enter Required Information Once the cartridge has been firmly inserted into the PTS Reader, the PTS Reader prompts the user to enter the following information: x Enter OID (Operator ID) x Enter Lot # (Cartridge Lot #) Note: If alternating between assay result formats, the user must delete all stored lot numbers in the PTS Reader before initiating a test.
® Endosafe - Portable Test System User’s Guide GRAM ID TEST RESULTS 1. When the test is complete, the PTS Reader gives an audible notification that the assay is finished. 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. 3.
® Endosafe - Portable Test System User’s Guide RETRIEVING RESULTS OPTIONS 1. You can download results directly to your PC and retrieve from the designated location file. ® 2. You can use the Seiko DPU-414 Printer or the Epson TM-U220D Printer (available from Charles River Laboratories) to print the last test result, all results from a particular date, or up to a maximum of one hundred (100) stored test results.
® Endosafe - Portable Test System User’s Guide Appendix C Endosafe® - PTS Inhibition/Enhancement Screen PERFORMING INHIBITION/ENHANCEMENT TEST An Inhibition/Enhancement PTS LAL assay is conducted by following the simple prompts on the PTS instrument. Different dilutions of one (1) sample can be placed in each sample well to determine the non-interfering dilution or different samples can be placed in each well of one (1) test cartridge. The following represents a typical assay procedure: 1.
® Endosafe - Portable Test System User’s Guide x x x x x x x x x x x x Enter Sample 2 Lot # (Sample 2 is the next well to the right of sample 1) Enter Sample 3 Lot # (Sample 3 is the next well to the right of sample 2) Enter Sample 4 Lot # (Sample 4 is the last well on the right) Enter Sample 1 ID (Selecting and scrolling with the menu key under the sample ID Header allows for fifty (50) samples to be entered and stored) Enter Sample 2 ID Enter Sample 3 ID Enter Sample 4 ID Enter Dilution #1 Factor Enter
® Endosafe - Portable Test System User’s Guide INHIBITION/ENHANCEMENT TEST RESULTS 1. When the test is complete, the PTS Reader gives an audible notification that the assay is finished. 2. At the conclusion of the test, the assay acceptance criteria are displayed on the screen. 3. The PTS Reader display alternates between the following results: x Spike #1 Recovery x Spike #2 Recovery x Spike #3 Recovery x Spike #4 Recovery The PTS Reader continues to display the assay results until cartridge is removed.
® Endosafe - Portable Test System User’s Guide RETRIEVING RESULTS OPTIONS You can download results directly to your PC and retrieve from the designated location file. ® 2. You can use the Seiko DPU-414 or the Epson TM-U220D Printer (available from Charles River Laboratories) to print the last test result, all results from a particular date, or up to a maximum of one hundred (100) stored test results. 1. ********* ENDOSAFE Test Record ********* V7.12B 12/9/2008 DateTime: ........
® Endosafe - Portable Test System User’s Guide Appendix D Endosafe® - PTS Rapid Micro Methods Glucan PERFORMING ROUTINE GLUCAN TEST The PTS Glucan assay is used for the detection of (1,3)-ȕ-D-Glucans. The Endosafe® -PTS Glucan assay is intended for research purposes only and is not to be used for diagnostic testing purposes. A routine PTS Glucan assay is conducted by following the simple prompts on the PTS instrument. The following represents a typical assay procedure: 1.
® Endosafe - Portable Test System User’s Guide x x x Enter Sample ID (Selecting and scrolling with the menu key under the sample ID Header allows for fifty (50) samples to be entered and stored) Enter Dilution Factor 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. 1.
® Endosafe - Portable Test System User’s Guide RETRIEVING RESULTS OPTIONS 1. You can download results directly to your PC and retrieve from the designated location file. ® 2. You can use the Seiko DPU-414 or the Epson TM-U220D Printer (available from Charles River Laboratories) to print the last test result, all results from a particular date, or up to a maximum of one hundred (100) stored test results. Example of Glucan Test Report: ********* ENDOSAFE Test Record ********* V7.12B 12/9/2008 DateTime: ....
® Endosafe - Portable Test System User’s Guide Appendix E Abbreviations used in this User’s Guide: PTS LAL FDA EU LRW Portable Test System Limulus Amebocyte Lysate Food and Drug Administration Endotoxin U nit LAL Reagent Water Copyright 2003 PIPTS101-10 Page E1
® Endosafe - Portable Test System User’s Guide Appendix F Decontamination Procedures Warning: Do not immerse the Endosafe® – PTS instrument, spray it with liquid, or use a “wet” cloth. Do not allow the cleaning solution to run into the interior of the Endosafe® – PTS instrument. If this happens, contact Charles River Laboratories Technical Service Department. Do not soak the keypad, this will cause damage.
