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Endosafe

- Portable Test System User’s Guide

Page 2

PIPTS101-10

–

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).

The Endosafe

- PTS Rapid Micro Methods are cartridges designed to accelerate a wide

range of quality control test methodologies. New assays are currently in development
and will be available as we adapt them to the PTS format.

The Rapid Micro Methods Gram ID assay is an alternative to conventional

gram stain methods for identification of microorganisms in approximately
3 to 7 minutes (see Appendix B for testing procedure and test results).

All components required for testing samples with the PTS are listed below.

Product

Description

Catalog #

Quantity

Endosafe

- PTS kit

Reader and integrated software

Power supply
Adapter cord (1)
Mini pipettor (1)
User’s Guide

Portable Test System

PTS100 Each

Endosafe

- Licensed PTS

Endotoxin Cartridge
(10 cartridges per package)

0.1 EU/mL sensitivity
0.05 EU/mL sensitivity
0.01 EU/mL sensitivity
0.005 EU/mL sensitivity

PTS201F
PTS2005F
PTS2001F
PTS20005F

10/pack

Endosafe

- Unlicensed PTS

Endotoxin Cartridge
(10 cartridges per package)

0.1 EU/mL sensitivity
0.05 EU/mL sensitivity
0.01 EU/mL sensitivity

PTS201
PTS2005
PTS2001

10/pack

Endosafe

- PTS

Inhibition/Enhancement Cartridge
(10 cartridges per package)

Inhibition/Enhancement
Screen

PTS220 10/pack

Endosafe

- PTS Rapid Micro

Methods Cartridge
(10 cartridges per package)

Gram ID

LRMMGI100

10/pack

Endosafe

- PTS Glucan Cartridge

(10 cartridges per package)

(1,3) –

-D-Glucan

RMMGS1000 10/pack

Note: Multi-cartridge packs are also available.
Visit online at www.criver.com for additional product information.

Endosafe

- PTS Reader Specifications

Temperature control: 37

º C +

º C

Data interface: RS232 serial port

Printer support: Thermal printer and dot matrix compatible

Data storage: Maximum of one hundred (100) stored test results.

Содержание Endosafe-PTS

Страница 1: ...osafe PTS Portable Test System USER S GUIDE Version 7 1023 Wappoo Road Suite 43 B Charleston SC 29407 Phone 843 766 7575 Fax 843 766 7576 www criver com endo comments crl com endotoxin and microbial detection ...

Страница 2: ...ication 5 Extended Warranty Program 5 On Demand Repairs 6 Returned Goods Authorization Procedure 6 Warranty Registration 6 Operating the Reader Battery Information 7 Keypad Operation 8 ON OFF 8 MENU Key 8 Example of Keypad Operation 10 Menu Shortcuts for PTS Reader Keypad 11 Cancel Key 11 Reader Output Downloading Output to PC using the PTS Logger Software 12 Printing with the DPU 414 Seiko Therma...

Страница 3: ...ons A3 Appendix B Performing Routine Gram ID Test B1 Gram ID Test Results B3 Retrieving Results Options B4 Appendix C Performing Inhibition Enhancement Test C1 Inhibition Enhancement Test Results C3 Retrieving Results Options C4 Appendix D Performing Routine Glucan Test D1 Glucan Test Results D2 Retrieving Results Options D3 Appendix E Abbreviations Used E1 Appendix F Decontamination Procedures F1...

Страница 4: ... interior components It does not contain any parts that can be maintained repaired or replaced by the user Doing so may cause fire or electric shock x DO NOT allow liquids to spill into the cartridge chamber Doing so may damage interior components and may cause fire or electric shock x DO NOT use sharply pointed objects to operate the keyboard of your system x DO NOT unplug AC power cord or PC cab...

Страница 5: ...the PTS are listed below Product Description Catalog Quantity Endosafe PTS kit Reader and integrated software Power supply Adapter cord 1 Mini pipettor 1 User s Guide Portable Test System PTS100 Each Endosafe Licensed PTS Endotoxin Cartridge 10 cartridges per package 0 1 EU mL sensitivity 0 05 EU mL sensitivity 0 01 EU mL sensitivity 0 005 EU mL sensitivity PTS201F PTS2005F PTS2001F PTS20005F 10 p...

Страница 6: ...Altitude unlimited x Weight 3 lbs corresponding 1100 Gram without power supply unit Endosafe PTS Cartridge Specifications x Reference package insert for storage requirements x Endotoxin Sensitivity 10 0 1 EU mL range 5 0 05 EU mL range 1 0 01 EU mL range 0 5 0 005 EU mL range see Appendix A x Rapid Micro Methods Gram ID Archived parameters for Gram negative Gram positive and Yeast Mold isolate ide...

Страница 7: ...o Seiko DPU 414 Printer PTS302 Epson TM U220D Printer AC powered non thermal unit PTS310 Epson Printer Cable Molded cable for Epson TM U220D Printer PTS311 Epson Printer Ribbon Ribbon for Epson TM U220D Printer PTS312 Epson Printer Paper Paper rolls for Epson TM U220D Printer PTS313 Endosafe PTS mini pipettor 25 μL disposable unit with 5 accuracy and 3 precision at full stroke PTS400 Protective re...

Страница 8: ... Additional service contracts are available as follows Service Code Annual Calibration Certification PTS500 Extended Warranty PTS501 IQ OQ PQ PTS502 On Demand Repairs PTS503 ANNUAL CALIBRATION CERTIFICATION The PTS instrument factory calibration which is certified at the time of initial shipment is valid for one 1 year Charles River Laboratories offers an annual re calibration service To request t...

Страница 9: ...all be responsible for all freight charges associated with the returned instrument and the loaner instrument RETURNED GOODS AUTHORIZATION PROCEDURE The client must obtain a Returned Goods Authorization Number from Charles River Laboratories before any items can be shipped to the Technical Services Department All goods returned for repair preventative maintenance or calibration whether under warran...

Страница 10: ...fully discharged Then repeat the full charge full discharge usage cycle Leaving the PTS on continuously with the external charger connected is not recommended NOTE If the PTS Reader is continuously connected to an external charger the batteries will self discharge approximately 10 to 15 and then the charging circuit will activate and restore the charge This will result in a shortened life span of ...

Страница 11: ... screen 2 Once Main Menu is displayed on the screen Use the Menu key repeatedly to scroll through the separate numbered headers that are available on the Main Menu 1 Enter Test Inf The PTS Reader will prompt the user for all pertinent test information automatically when a cartridge is inserted It is not necessary to Enter Test Info under this header 2 User Setup The majority of the options under t...

Страница 12: ...ages 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 7 System Info This header of the Main Menu allows you to view system information such as the serial number and the system software version Becoming familiar with available options from each of the numbered headers of the Main ...

Страница 13: ...ime setting feature 1 Set Time 2 12 Hour 3 24 Hour 6 For each of the 3 Time Menu items you can press the ENTER key to enter the appropriate information regarding the time settings and preferences you want the system to use 7 For example if you press ENTER when the PTS Reader displays 1 Set Time you will see the default time on the PTS Reader screen A cursor will appear below the first number which...

Страница 14: ... Set Date M322 2 MON DAY YEAR M323 3 DAY MON YEAR PRINT MENU M41 1 Print Last Tst M42 2 Print All Tsts on given date M43 3 Print All Tsts M44 4 Print 40 Character format M45 5 Tests Stored M46 6 Printer Test M47 7 Erase All Recs M5 5 System OFF M6 6 System Reset M7 7 System Info E CANCEL KEY Pressing the CANCEL key at any time during data entry to the PTS Reader will return the display to the prev...

Страница 15: ... 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 Select Log then Open Close Log to open the log 5 Press the MENU key on the PTS Reader keypad Select 4 for the Print Menu The options for downloading data to the PC are 1 Print Last Test 2 Print by Date 3 Print all Tests Selecting one 1...

Страница 16: ...rinting with the DPU 414 Seiko Thermal Printer or the Epson TM U220D Printer 1 Setup printer according to owner s manual instructions 2 Connect Cable Serial port connection to Printer and RJ45 plug in back of the PTS Reader Cable is provided with PTS System 3 Press the MENU key on the PTS Reader keypad 4 Select 4 for the Print Menu The options for downloading data to the Printer are 1 Print Last T...

Страница 17: ... ac cq qu ui is si it ti io on n 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 ...

Страница 18: ...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 Select the Send Setup button to send information to the PTS Reader 11 Once the Add sample and Click start message is displayed dispense 25 μL into each well of the test cartridge and click start on the...

Страница 19: ...ar 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 The unit will perform a system self check and return to keypad operati...

Страница 20: ...perature is too low TEMP TOO HI Cartridge temperature is too high MOTOR NOT HOME Cannot run pump motor CLOCK FAULT Cannot read Real Time Clock Computing Error Divide by 0 or range error Charge Battery Batteries too weak to run tests Battery Fault Battery charging problem UNKNOWN Any unspecified system fault One or more test LEDs out of spec Abort Test CANCEL OR ENTER One or more of the LEDs does n...

Страница 21: ...t front of the PTS Reader Press cartridge firmly into slot 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 x Enter Calibration Code If the Calibration Code for the particular lot has already been entered the PTS Reader does not prompt for...

Страница 22: ...ls thereby initiating the test x Results will be obtained in approximately 15 minutes ENDOTOXIN 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 endotoxin measurement and the assay acceptance criteria are displayed on the screen 3 The PTS Reader display alternates between the following results x Sam...

Страница 23: ...ar date or up to a maximum of one hundred 100 stored test results ENDOSAFE Test Record V7 12B 12 9 2008 DateTime 05 07 09 11 04 12AM Device 0019 OperatorID KMULIK Cartridge Endotoxin Temperature Start 37 0C End 37 0C Method KX 122 Cartridge Lot 9478126 Cartridge Cal Code 511534382938 Range 5 0 05 Range Time Sec 115 743 Onset Times 743 294 743 290 Slope 0 405 Intercept 2 344 Dilution 1 Sample Lot 9...

Страница 24: ...oes not differentiate between Gram positive and Yeast Mold isolates Reference the Certificate of Analysis for the calibration code to be used for each assay result format Sample Preparation From an isolated culture carefully remove colonies from agar surface and suspend cells in approximately 2 mLs of LPS free Saline or LRW and adjust to a 0 5 McFarland Equivalence Turbidity Standard Note Do not u...

Страница 25: ...ader the user will be prompted to enter in the calibration code x Lot Confirms cartridge lot number entered x Enter Sample 1 Lot This prompt is available for all four 4 samples x 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 While the above information is being entered into the PTS Reader the cartridge is...

Страница 26: ... 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 The PTS Reader display alternates between the following results x Sample 1 x Sample 2 x Sample 3 x Sample 4 x Remove Cartridge The PTS Reader continues to display the assay results until the cartridge is removed ...

Страница 27: ...dge Lot 8294900 Cartridge Cal Code 515015143077 Onset Times 150 150 151 151 Sample 1 Lot EC0012 Sample 1 ID TB 1 Sample 2 Lot EC0013 Sample 2 ID TB 2 Sample 3 Lot BC0004 Sample 3 ID FL 1 Sample 4 Lot BC0005 Sample 4 ID GL 1 Sample 1 Gram Negative Sample 2 Gram Negative Sample 3 Gram Positive Sample 4 Gram Positive Example of Gram negative Yeast Mold or Gram positive assay result format report ENDO...

Страница 28: ...y 5 minutes x The PTS Reader displays SELF TEST OK and then INSERT CARTRIDGE 2 Insert the Cartridge Remove cartridge from pouch and insert with sample reservoirs facing up into slot at front of the PTS Reader Press cartridge firmly into slot Note 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...

Страница 29: ...Enter Dilution 1 Factor x Enter Dilution 2 Factor x Enter Dilution 3 Factor x Enter Dilution 4 Factor x 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 PTS Reader the cartridge is being pre warmed 4 Dispense the Sample Once all test information is entered the PTS Reader disp...

Страница 30: ...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 Once the assay is complete and the results are noted remove the cartridge promptly from...

Страница 31: ...est results ENDOSAFE Test Record V7 12B 12 9 2008 DateTime 05 07 09 09 28 35AM Device 0019 OperatorID KMULIK Cartridge I E Screen Temperature Start 37 0C End 37 0C Method KX 410 Cartridge Lot 9454812 Cartridge Cal Code 509025092498 Range 5 0 05 Range Time Sec 90 650 Onset Times 650 530 294 272 Slope 0 429 Intercept 2 254 Dilution 1 10 Sample 1 Lot 07106 Sample 1 ID ETHANOL Dilution 2 50 Sample 2 L...

Страница 32: ...s it heats up to 37 C this takes approximately 5 minutes x The reader displays SELF TEST OK and then INSERT CARTRIDGE 2 Insert the Cartridge Remove cartridge from pouch and insert with sample reservoirs facing up into slot at front of the PTS Reader Press cartridge firmly into slot Note Allow the cartridge to come to room temperature in pouch before use 3 Enter Required Information Once the cartri...

Страница 33: ...nto four 4 sample reservoirs of the inserted cartridge and press Enter on the reader keypad x Pumps draw sample aliquots into the test channels thereby initiating the test x Results will be obtained in approximately 30 minutes GLUCAN 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 glucan measuremen...

Страница 34: ...aximum of one hundred 100 stored test results Example of Glucan Test Report ENDOSAFE Test Record V7 12B 12 9 2008 DateTime 04 21 09 08 59 40AM Device 0633 OperatorID DN Cartridge PTS Glucan Temperature Start 37 0C End 37 0C Method KX 122 Cartridge Lot 9107441 Cartridge Cal Code 901630102934 Range 1000 10 00 Range Time Sec 16 701 Onset Times 701 098 701 102 Slope 0 821 Intercept 3 667 Dilution 1 Sa...

Страница 35: ...e P PT TS S P Po or rt ta ab bl le e T Te es st t S Sy ys st te em m L LA AL L L Li im mu ul lu us s A Am me eb bo oc cy yt te e L Ly ys sa at te e F FD DA A F Fo oo od d a an nd d D Dr ru ug g A Ad dm mi in ni is st tr ra at ti io on n E EU U E En nd do ot to ox xi in n U Un ni it t L LR RW W L LA AL L R Re ea ag ge en nt t W Wa at te er r Copyright 2003 Page E1 PIPTS101 10 ...

Страница 36: ... 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 Important Turn off and unplug the Endosafe PTS instrument for all decontamination and cleaning operations 1 Turn off and unplug the Endosafe PTS instrument 2 Moisten a cloth with a mild detergent solution Do not soak ...

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