Charles River Optio WGGPS2, Optio WG 2, Endosafe-PTS Operating Manual

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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

Endosafe® - Portable Test System User’s Guide

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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 ............................................................... 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 Thermal Printer or the

Epson TM-U220D Printer ................................................................... 13

Using EndoScan-V with Endosafe

– PTS for data acquisition……...14

Troubleshooting .................................................................................... 17

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Endosafe® - Portable Test System User’s Guide

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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 .................................................................. 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

PIPTS101-10

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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.

CAUTION

x DO NOT open the instrument and tamper with the 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.

Endosafe® - Portable Test System User’s Guide

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 cable by pulling cord/cable directly. Doing

so may damage cord and cause injury. Handle the AC adapter and Serial Port Connector directly to unplug.

Read this User’s Guide carefully before using the Endosafe®- PTS System. Understanding- the proper usage and operation is imperative

for the safety of the User, as well as the protection of the Endosafe®PTS System.

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

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

Endosafe®- Licensed PTS Endotoxin Cartridge (10 cartridges per package)

Endosafe®- Unlicensed PTS Endotoxin Cartridge (10 cartridges per package)

Endosafe®- PTS Inhibition/Enhancement Cartridge (10 cartridges per package)

Endosafe®- PTS Rapid Micro Methods Cartridge (10 cartridges per package)

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- PTS Endotoxin test utilizes existing

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

x 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).

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Portable Test System

0.1 EU/mL sensitivity

0.05 EU/mL sensitivity

0.01 EU/mL sensitivity

0.005 EU/mL sensitivity

0.1 EU/mL sensitivity

0.05 EU/mL sensitivity

0.01 EU/mL sensitivity

Inhibition/Enhancement Screen

Gram ID LRMMGI100 10/pack

Endosafe® - Portable Test System User’s Guide

PTS100 Each

PTS201F PTS2005F PTS2001F PTS20005F PTS201 PTS2005 PTS2001

PTS220 10/pack

10/pack

Endosafe®- PTS Glucan Cartridge (10 cartridges per package) Note: Multi-cartridge packs are also available. Visit online at www.criver.com

. Endosafe

x Temperature control: 37º C + 1º C

x Data interface: RS232 serial port x Printer support: Thermal printer and dot matrix compatible x Data storage: Maximum of one hundred (100) stored test results.

- PTS Reader Specifications

PIPTS101-10

(1,3) –

for additional product information.

ȕ-D-Glucan

RMMGS1000 10/pack

x Dimensions: 9.25” x 4.625” x 2.50” corresponding 235 mm (D) x 128 mm (W) x

65 mm (H)

x Power supply unit: 100-240 V, 50-60 Hertz x Power supply on board: 12 V DC, 5A x Battery life: 6 - 8 hours of operation post-charge x Warm-up time: Approximately 5 -10 minutes from 20º C start x Display: Two (2) lines of sixteen (16) characters each x Environmental Conditions:

¾ Operating Temperature 15º to 27 º C

¾ Humidity 5% to 95% noncondensing ¾ Indoor and outdoor use ¾ Altitude - unlimited

Endosafe® - Portable Test System User’s Guide

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 identification (see Appendix B)

x Inhibition/Enhancement Screening (see Appendix C) x Rapid Micro Methods – Glucan (see Appendix D)

x Acceptable temperature: 37º C +

1º C

Sample requirement: 25 L sample per channel

NOTE: Sample must be delivered to each sample port without contamination or cross

contamination between samples.

PIPTS101-10

Endosafe®- PTS Accessory Products

Endosafe® - Portable Test System User’s Guide

Product

Description Code

PC Cable Molded cable for PTS Reader to PCPTS108

AC Adaptor AC Adaptor for the PTS Reader PTS109

Seiko® DPU-414 Printer

Battery powered, rechargeable

PTS300

thermal unit

Seiko Printer Paper

Thermal paper rolls for Seiko

PTS301

DPU-414 Printer

Seiko Printer Cable Molded cable for PTS Reader to

Seiko

DPU-414 Printer

PTS302

Epson TM-U220D Printer AC powered non-thermal unit PTS310

Epson Printer Cable Molded cable for Epson

PTS311

TM-U220D Printer

Epson Printer Ribbon Ribbon for Epson TM-U220D

PTS312

Printer

Epson Printer Paper Paper rolls for Epson TM-U220D

PTS313

Printer

Endosafe®- PTS mini pipettor

25 L disposable unit with + accuracy and +

3% precision at

PTS400

full stroke

Protective reader case Solid plastic, with handle for

PTS600

instruments and supplies

Eppendorf

pipette tips

200 L, individually wrapped,

D100

validated to 0.005 EU/mL

*Eppendorf is a registered trademark of Brinkmann

Multiple patents pending.

PIPTS101-10

Endosafe®- PTS Service Programs

Endosafe® - Portable Test System User’s Guide

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.

During the warranty period, Charles River Laboratories will repair the instrument at no charge to the client for parts and labor. If repairs are needed, Charles River Laboratories will provide the client a loaner instrument during the period the instrument is being repaired. The client shall be responsible for all freight charges associated with the returned instrument and the loaner instrument.

Opening the case or tampering with the interior components of the PTS Reader will invalidate warranty provisions.

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 this service, the client must notify the Company sixty (60) days prior to the end of the initial calibration period to arrange for re-calibration service.

EXTENDED WARRANTY PROGRAM

The Extended Warranty Program is available to the client during the 1st year from the date of purchase of the initial Warranty Period.

This service program includes:

A. A diagnostic and performance check, including replacement or repair of parts as

necessary to return the instrument to original performance specifications.

B. Loading software improvements/upgrades introduced to the PTS design since last

inspection. C. A complete instrument cleaning operation. D. Certification for the extension of the Warranty Period for another four (4) years.

PIPTS101-10

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

ON DEMAND REPAIRS

After the initial Warranty Period has ended, the client may request Charles River Laboratories to service or repair the PTS instrument without having the benefit of one of the above Service Agreements.

Charles River Laboratories will arrange transfer of the PTS instrument to the Company’s technical services laboratory, and provide the client a loaner instrument during the

period On Demand repairs are being made (See Returned Goods Authorization Procedure below). The client shall 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 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 this User’s Guide, and is also available online at www.criver.com 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 in the Service Agreement. For answers to questions about any of

these components for the Endosafe contact Charles River Laboratories Technical Services Department:

United States: 1023 Wappoo Road, Suite 43-B Charleston, SC 29407 USA

Europe: 00 800 15 78 97 43

. Submitting the completed card will permit the Technical

- PTS or for additional product information, please

(800) 762-7016

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

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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. The following procedures are presented so the user can experience the maximum useful performance and life from the batteries.

The batteries should be fully charged (about 4 to 4.5 hours) before use. This will give approximately 6 to 8 hours of continuous usage. To charge the batteries, use only the AC power adapter supplied with the instrument.

NOTE: Insert the power cord into any grounded 3-prong outlet, and then insert the DC plug into the rear of the PTS Reader. The AC power cord adapter displays a green LED when the cord is securely plugged into a wall outlet. If this light does not appear, try a different socket or make sure the power cord is properly inserted into the outlet. Never use a charger that is damaged.

A desirable operating condition for the batteries is to be fully charged and then used to operate the PTS Reader on battery power until a low level of charge is reached – best if 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 the batteries.

When operating on batteries, eventually a “LOW BATTERY” message will be displayed indicating that only one (1) or two (2) more tests can be performed before the battery charge is too low to initiate and complete another test. The AC power adapter must then be connected to continue operation. Testing can be resumed as the batteries are in the process of being charged.

As the batteries approach their end of life (approximately 300 charge-discharge cycles), the number of tests that can be run on one (1) charge will diminish. The “Charge Battery” message will start to appear more often. The user will be alerted with the display and an audible beep every 5 minutes that there is a “Battery Issue – See User Manual”. The alerts will also occur on system start-up but will not occur during a test. If the alerts are not heeded, and the batteries eventually reach full discharge, the PTS Reader will shut down, but will resume operation within 1 minute once the AC power adapter has been connected. Although operational with end-of-life batteries, the PTS Reader will be vulnerable to power interruptions. In all instances, when the batteries approach end of life, the PTS Reader should be returned to the factory for battery replacement.

PIPTS101-10

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. The following overview of the PTS keypad operation covers all necessary functions and procedures for proper use of the PTS Reader during test operations.

ON/OFF

ON – When using battery power, pressing the MENU key on the keypad will turn

the instrument on.

OFF – Pressing the MENU key from the initial screen followed by the 5 key will

turn the instrument off, conserving battery power.

NOTE: Press CANCEL to return to the initial screen.

B. MENU KEY

1. Pressing the Menu key initiates the Main Menu display on the PTS Reader’s

information 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 this header are for

factory use only. If selected, “Action Denied” will be displayed on the screen with an audible notification. The user has the capability of erasing all stored lot numbers under this heading.

#3 - System Menu – This header allows you to enter a variety of constants,

such as: Time Menu, Date Menu, Languages, System Options, and setting the COM1 Baud rate.

NOTE: Selecting any sub-header that is for factory use only will display

“Action Denied” on the screen with an audible notification.

#4 - Print Menu – This header allows you to set options to govern the data

printing process for your test results, and includes settings for: Printing the Last Test, Print all tests by a given date, Printing All Tests stored on the PTS Reader (up to 100 max.), Print 40 Character Line, A Display of # of Tests stored on the reader, Performing a Printer Test, and Erasing All Records.

PIPTS101-10

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 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.

#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 Menu, allows you to proceed with greater speed and confidence

as you perform your tests and specific data collection.

DPU-414 Printer, or Epson TM-U220D Printer to store prior to

PIPTS101-10

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. Use the MENU key to scroll through the options governing the time

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 allows you to enter a new number in that position to format the correct time. Simply move the cursor left or right using the ŻŹ arrow keys, and press the numeral keys on the keypad to enter the correct time

8. Once you have entered the appropriate information, press the ENTER

key

ĺ The PTS Reader displays your entry and Stored, to

indicate the data was stored successfully

PIPTS101-10

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

MAIN MENU M2 USER SETUP M24 4-Erase Lot Numb M25 5-Channel EU YES/NO M3 3-System Menu

SYSTEM MENU

M31 1- Displ DateTime

TIME MENU M331 1-Set Time M332 2-12 Hour M333 3-24 Hour

M321 1-Set Date M322 2-MON/DAY/YEAR M323 3-DAY/MON/YEAR

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 previous numbered header of the Main Menu.

If you continue to press the CANCEL key, the display will cycle over to the Main Menu display, and subsequently out of all menus, at which point the PTS Reader will display Insert Cartridge. At this point, if all necessary information has been

entered to the PTS Reader for the test setup, testing can begin.

DATE MENU

PRINT MENU

PIPTS101-10

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. 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) of the above three (3) choices to print will automatically download results to the PTS Logger software if connected as described above.

PIPTS101-10

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.

Printing with the DPU-414 Seiko Thermal Printer or the Epson TMU220D 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 Test 2-Print by Date 3-Print all Tests

5. Selecting one (1) of the above three (3) choices on the PTS Reader keypad will send results to the connected Printer.

6. If the user desires to also download data to a PC, follow instructions

above for Downloading Output to PC using the PTS Logger software.

PIPTS101-10

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Endosafe® - Portable Test System User’s Guide

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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.

PIPTS101-10

5. Enter the Cartridge lot number. The cartridge lot number will be

Endosafe® - Portable Test System User’s Guide

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. 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 L into each well of the test cartridge and click start on the screen.

12. While in progress the screen will display messages showing the current progress.

PIPTS101-10

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. The unit will perform a system self-check and return to keypad operations.

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

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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.

MESSAGE DESCRIPTION

“A2D SETUP” Photo A/D set up did not complete

“TEMP TOO LOW” Cartridge temperature 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”

“Sample Not Seen” flashes during test

If any of these or other problems persists, contact Charles River Laboratories Technical Service:

United States: 1023 Wappoo Road, Suite 43-B Charleston, SC 29407 USA

(800) 762-7016

Europe: 00 800 15 78 97 43

Fax: (843) 766-7576 E-Mail: endo-comments@crl.com

One or more of the LEDs does not have sufficient intensity to run the test properly

Sample was not detected in one or more of the optical cells

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

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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 Press the MENU key on the PTS keypad to turn instrument on (Menu 5 turns

instrument off).

x The PTS Reader initiates a “SYSTEM SELF TEST” as it heats up to 37°C –

this takes approximately 5 minutes.

x The PTS Reader displays “SELF TEST OK” and then “INSERT

CARTRIDGE”.

2. Insert the Cartridge

Note: Allow the cartridge to come to room temperature in pouch before use.

Remove cartridge from pouch and insert with sample reservoirs facing up into slot at 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 the code again. (To Erase all stored lot #’s and corresponding calibration codes, select menu, 2, then 4 from the initial menu)

x Lot # (Confirms cartridge lot number entered) x Enter Sample Lot # 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)

x Enter Dilution 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.

PIPTS101-10

4. Dispense the Sample

Once all test information is entered, the PTS Reader displays:

Endosafe

- Portable Test System User’s Guide

x ADD SAMPLE; PRESS ENTER

x Pipette 25 L 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. 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 Sample EU/mL x Sample %CV x Spike EU/mL x Spike %CV x % Spike Recovery x Remove Cartridge

The PTS Reader continues to display the assay results until cartridge is removed.

PIPTS101-10

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

(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: ........ 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: ................... 99732086

Sample ID: ......................... LRW

Sample Rxn Time CV: .......... 0.0% Pass

Spike Value: .............. 0.451 EU/mL

Spike Rxn Time CV: ........... 1.0% Pass

Spike Recovery: ............. 92% Pass

Test Suitability: ................. Pass

Sample Value: ............. <0.050 EU/mL

DPU-414 Printer or the Epson TM-U220D Printer

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

AAppppeennddiixxB

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. One assay result format will report the presence of either Gram-negative microorganisms, Yeast/Mold or Gram-positive microorganisms in approximately 7 minutes. The second assay result format will report the presence of Gram-negative and Gram-positive in approximately 3 minutes (this format does 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 use cotton tip swabs of any kind during sample preparation.

1. Instrument Operation

x Press the MENU key on the PTS keypad to turn instrument on (Menu 5

turns instrument off).

x The PTS Reader initiates a “SYSTEM SELF

TEST” as it heats up to 37°C – this takes approximately 5 minutes.

x The PTS Reader displays “SELF TEST OK” and

the “INSERT CARTRIDGE”.

2. Insert the Cartridge

Remove cartridge from pouch and insert with sample reservoirs facing into slot at front of the PTS Reader.

Press cartridge firmly into slot.

PIPTS101-10

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. This is done by selecting Main Menu > #2 User Setup> #4 Erase Lot Numbers. Select Enter to erase all stored lot numbers

x Enter Calibration Code (If the Calibration Code for the particular lot #

has already been entered, the PTS Reader does not prompt for the code again. After deleting stored lot numbers in the PTS Reader, 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 being pre-warmed.

4. Dispense the Sample

Once all test information is entered, the PTS Reader displays:

x ADD SAMPLE; PRESS ENTER

x Pipette 25L of first sample into one (1) sample reservoir of the inserted

cartridge. Change pipette tip to avoid cross-contamination between each sample. After all four (4) sample reservoirs are filled, 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 7 minutes for Gram-negative,

Gram-positive and Yeast/Mold identification and 3 minutes for Gramnegative and Gram-positive identification.

PIPTS101-10

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. 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.

PIPTS101-10

RETRIEVING RESULTS OPTIONS

Endosafe® - Portable Test System User’s Guide

1. You can download results directly to your PC and retrieve from the designated

location file.

2. You can use the Seiko (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 Gram-negative or Gram-positive assay result format report:

********* ENDOSAFE Test Record ********* V7.12A 7/30/2008

DateTime: ........ 10/29/08 @ 12:02:26PM

Device: ........................... 0560

OperatorID: ......................... DN

Cartridge: ..................... Gram ID

Temperature: .. Start: 37.0C End: 37.0C

Method: ........................ GSX-401

Cartridge 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

DPU-414 Printer or the Epson TM-U220D Printer

Example of Gram-negative, Yeast/Mold or Gram-positive assay result format report:

********* ENDOSAFE Test Record ********* V7.12A 7/30/2008

DateTime: ........ 10/29/08 @ 11:45:32AM

Device: ........................... 0560

OperatorID: ......................... DN

Cartridge: ..................... Gram ID

Temperature: .. Start: 37.0C End: 37.0C

Method: ........................ GSX-401

Cartridge Lot#: ................ 8294900

Cartridge Cal Code: ....... 515040043099

Onset Times: .......... 344 360 352 380

Sample #1 Lot: .................. EC0001

Sample #1 ID: ..................... FL-2

Sample #2 Lot: .................. CA0002

Sample #2 ID: ..................... FL-2

Sample #3 Lot: .................. CA0003

Sample #3 ID: ..................... TB-3

Sample #4 Lot: .................. BC0006

Sample #4 ID: ..................... GL-2

Sample #1: ............. Gram Negative

Sample #2: .............. Yeast / Mold

Sample #3: .............. Yeast / Mold

Sample #4: ............. Gram Positive

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

AAppppeennddiixxC

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. Instrument Operation

x Press the MENU key on the PTS keypad to turn instrument on (Menu 5 turns

instrument off).

x The PTS Reader initiates a “SYSTEM SELF TEST” as it heats up to 37°C –

this takes approximately 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 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 reader does not prompt for the code again. (To Erase all stored lot #’s and corresponding calibration codes, select menu, 2, then 4 from the initial menu)

x Lot # (Confirms cartridge lot number entered) x Enter Sample 1 Lot # (Sample 1 is designated as the well on the far left after

cartridge is inserted into the PTS Reader)

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

Enter Sample 2 Lot # (Sample 2 is the next well to the right of sample 1)

x Enter Sample 3 Lot # (Sample 3 is the next well to the right of sample 2) x Enter Sample 4 Lot # (Sample 4 is the last well on the right) 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)

x Enter Sample 2 ID x Enter Sample 3 ID x Enter Sample 4 ID x 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.

Dispense the Sample

Once all test information is entered, the PTS Reader displays:

x ADD SAMPLE; PRESS ENTER

x Pipette 25 L of sample into 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.

PIPTS101-10

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. Once the assay is complete and the results are noted, remove the cartridge promptly from the PTS Reader.

PIPTS101-10

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

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: ........ 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 Lot: ................... 07106

Sample #2 ID: .................. ETHANOL

Dilution #3: ....................... 100

Sample #3 Lot: ................... 07106

Sample #3 ID: .................. ETHANOL

Dilution #4: ....................... 500

Sample #4 Lot: ................... 07106

Sample #4 ID: .................. ETHANOL

Spike #1 Recovery: ............... < 11%

Spike #2 Recovery: ............... 18%

Spike #3 Recovery: ............... 72%

Spike #4 Recovery: ............... 86%

DPU-414 or the Epson TM-U220D Printer (available

Endosafe® - Portable Test System User’s Guide

PIPTS101-10

Endosafe

- Portable Test System User’s Guide

AAppppeennddiixxD

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. Instrument Operation x Press the MENU key on the PTS keypad to turn instrument on (Menu 5

turns instrument off)

x The reader initiates a “SYSTEM SELF TEST” as 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 cartridge has been firmly inserted into the reader, the 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 reader does not prompt for the code again. (To Erase all stored lot #’s and corresponding calibration codes, select menu, 2, then 4 from the initial menu)

x Lot # (Confirms cartridge lot number entered) x Enter Sample Lot #

PIPTS101-10

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)

x Enter Dilution Factor

x 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. Dispense the sample

Once all test information is entered, the reader displays:

x ADD SAMPLE; PRESS ENTER

x Pipette 25 L of sample into 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.

Endosafe

- Portable Test System User’s Guide

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 measurement and the assay acceptance criteria are displayed on the screen.

3. The reader display alternates between the following results:

x Sample pg/mL Value x Sample %CV x Spike pg/mL Value x Spike %CV x % Spike Recovery x Remove Cartridge

The 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 the reader.

PIPTS101-10

RETRIEVING RESULTS OPTIONS

Endosafe

- Portable Test System User’s Guide

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: ........ 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

Sample Lot: ................... 21042009

Sample ID: ...................... RD0901

Sample Rxn Time CV: .......... 0.0% Pass

Spike Value: ............... 97.2 pg/mL

Spike Rxn Time CV: ........... 2.8% Pass

Spike Recovery: ............. 99% Pass

Test Suitability: ................. Pass

Sample Value: .............. <10.0 pg/mL

PIPTS101-10

Endosafe® - Portable Test System User’s Guide

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PIPTS101-10

Page E1

Endosafe® - Portable Test System User’s Guide

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Warning: Do not immerse the Endosafe “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.

Important! Turn off and unplug the Endosafe and cleaning operations.

1. Turn off and unplug the Endosafe

2. Moisten a cloth with a mild detergent solution. Do not soak the cloth. Wipe down all surfaces of the Endosafe

3. Use a clean dry cloth to dry all wet surfaces.

– PTS instrument, spray it with liquid, or use a

– PTS instrument for all decontamination

– PTS instrument.

–

PIPTS101-10

Charles River Optio WGGPS2, Optio WG 2, Endosafe-PTS Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual