Summary of Contents for Charles River Optio WGGPS2
- Page 1 ® 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.com...
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Page 2: Table Of Contents
® Endosafe - Portable Test System User’s Guide Safety Guidelines .................. 1 ® Endosafe PTS System Overview Reader Specifications ................2 Cartridge Specifications ..............3 Accessory Products ................4 ® Endosafe PTS Service Programs Warranty with Purchase ..............5 Annual Calibration Certification ............5 Extended Warranty Program ............... - Page 3 ® Endosafe - Portable Test System User’s Guide 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 ................B3 Retrieving Results Options ..............
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Page 4: Safety Guidelines
® Endosafe - Portable Test System User’s Guide WARNING 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. DO NOT place PTS system or charge battery around any liquids or use in a location where it could get wet or splashed. -
Page 5: Endosafe ® - Pts System Overview
® Endosafe - Portable Test System User’s Guide ® ® – – ® 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. -
Page 6: Cartridge Specifications
® Endosafe - Portable Test System User’s Guide Dimensions: 9.25” x 4.625” x 2.50” corresponding 235 mm (D) x 128 mm (W) x 65 mm (H) Power supply unit: 100-240 V, 50-60 Hertz Power supply on board: 12 V DC, 5A Battery life: 6 - 8 hours of operation post-charge Warm-up time: Approximately 5 -10 minutes from 20º... -
Page 7: Accessory Products
® Endosafe - Portable Test System User’s Guide ® Endosafe - PTS Accessory Products Product Description Code PC Cable Molded cable for PTS Reader to PTS108 AC Adaptor AC Adaptor for the PTS Reader PTS109 ® Battery powered, rechargeable PTS300 Seiko DPU-414 Printer thermal unit... -
Page 8: Endosafe Pts Service Programs Warranty With Purchase
® 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. -
Page 9: On Demand Repairs
® 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). -
Page 10: Operating The Reader
® Endosafe - Portable Test System User’s Guide 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. -
Page 11: Keypad Operation
® 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. - Page 12 ® 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 ®...
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Page 13: Example Of Keypad Operation
® Endosafe - Portable Test System User’s Guide EXAMPLE OF KEYPAD OPERATION Setting the Time on the PTS Reader: 1. Turn the instrument on by pressing the MENU key The PTS Reader displays Insert Cartridge after Systems Self Test 2. Press the MENU key The PTS Reader displays Main Menu and 1-Enter Test Inf 3. -
Page 14: Menu Shortcuts For Pts Reader Keypad
® Endosafe - Portable Test System User’s Guide 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. -
Page 15: Reader Output
® 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). -
Page 16: Printing With The Dpu-414 Seiko Thermal Printer Or The Epson Tm-U220D Printer
® 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. -
Page 17: Using Endoscan-V With Endosafe - Pts For Data Acquisition
® Endosafe - Portable Test System User’s Guide ® ® 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. - Page 18 ® 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.
- Page 19 ® 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.
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Page 20: Troubleshooting
® Endosafe - Portable Test System User’s Guide Listed in the table below are various Error or Fault Messages and a description of the corresponding cause of the error or fault. One or more LONG audible tones will precede each error message. Any fault listed here will prevent the PTS Reader from running a test. -
Page 21: Performing Routine Endotoxin Test
® Endosafe - Portable Test System User’s Guide ® 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. -
Page 22: Endotoxin Test Results
® Endosafe Portable Test System User’s Guide 4. Dispense the Sample Once all test information is entered, the PTS Reader displays: ADD SAMPLE; PRESS ENTER Pipette 25 μL of sample into all four (4) sample reservoirs of the inserted cartridge and press Enter on the PTS Reader keypad. -
Page 23: Retrieving Results Options
® 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. ® 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. -
Page 24: Performing Routine Gram Id Test
® Endosafe - Portable Test System User’s Guide ® 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. - Page 25 ® Endosafe - Portable Test System User’s Guide Note: If refrigerated, allow the cartridge to come to room temperature in pouch before use. 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: Enter OID (Operator ID) Enter Lot # (Cartridge Lot #) Note: If alternating between assay result formats, the user must delete all...
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Page 26: Gram Id Test Results
® Endosafe - Portable Test System User’s Guide GRAM ID TEST RESULTS 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. -
Page 27: Retrieving Results Options
® 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 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. -
Page 28: Performing Inhibition/Enhancement Test
® Endosafe - Portable Test System User’s Guide ® 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. - Page 29 ® Endosafe - Portable Test System User’s Guide 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)
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Page 30: Inhibition/Enhancement Test Results
® 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. -
Page 31: Retrieving Results Options
® 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. ® 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 ********* ENDOSAFE Test Record ********* V7.12B 12/9/2008... -
Page 32: Performing Routine Glucan Test
® Endosafe Portable Test System User’s Guide ® Endosafe - PTS Rapid Micro Methods Glucan PERFORMING ROUTINE GLUCAN TEST The PTS Glucan assay is used for the detection of (1,3)- -D-Glucans. The ® Endosafe -PTS Glucan assay is intended for research purposes only and is not to be used for diagnostic testing purposes. -
Page 33: Glucan Test Results
® Endosafe Portable Test System User’s Guide 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. -
Page 34: Retrieving Results Options
® 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. -
Page 35: Abbreviations Used
® Endosafe - Portable Test System User’s Guide ’ ’ Copyright 2003 Page E1 PIPTS101-10... - Page 36 ® Endosafe - Portable Test System User’s Guide ® 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 –...