Endosafe-PTS User`s Guide - Charles River Laboratories

®
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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Endosafe - Portable Test System User’s Guide
Table of Contents
Safety Guidelines .................................................................................. 1
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Endosafe - PTS System Overview
Reader Specifications .......................................................................... 2
Cartridge Specifications ...................................................................... 3
Accessory Products ............................................................................. 4
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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
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Using EndoScan-V with Endosafe – PTS for data acquisition……...14
Troubleshooting .................................................................................... 17
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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 .......................................................................... 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
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PIPTS101-10
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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.
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.
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.
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Endosafe - Portable Test System User’s Guide
Endosafe®- PTS – System Overview
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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
®
PTS100
Each
Endosafe - PTS kit
Portable
Test
System
Reader and integrated software
Power supply
Adapter cord (1)
Mini pipettor (1)
User’s Guide
®
0.1 EU/mL sensitivity
PTS201F
10/pack
Endosafe - Licensed PTS
0.05
EU/mL
sensitivity
PTS2005F
Endotoxin Cartridge
0.01 EU/mL sensitivity
PTS2001F
(10 cartridges per package)
0.005 EU/mL sensitivity
PTS20005F
®
0.1 EU/mL sensitivity
PTS201
10/pack
Endosafe - Unlicensed PTS
0.05
EU/mL
sensitivity
PTS2005
Endotoxin Cartridge
0.01 EU/mL sensitivity
PTS2001
(10 cartridges per package)
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Inhibition/Enhancement
PTS220
10/pack
Endosafe - PTS
Screen
Inhibition/Enhancement Cartridge
(10 cartridges per package)
®
Gram ID
LRMMGI100
10/pack
Endosafe - PTS Rapid Micro
Methods Cartridge
(10 cartridges per package)
x
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RMMGS1000
Endosafe - PTS Glucan Cartridge (1,3) – ȕ-D-Glucan
(10 cartridges per package)
Note: Multi-cartridge packs are also available.
Visit online at www.criver.com for additional product information.
10/pack
®
. Endosafe - PTS Reader Specifications
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.
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Endosafe - Portable Test System User’s Guide
x
x
x
x
x
x
x
x
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 C start
Display: Two (2) lines of sixteen (16) characters each
Environmental Conditions:
¾ Operating Temperature 15º to 27 º C
¾ Humidity 5% to 95% noncondensing
¾ Indoor and outdoor use
¾ Altitude - unlimited
Weight: 3 lbs. corresponding 1100 Gram (without power supply unit)
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Endosafe - PTS Cartridge Specifications
x
x
x
x
x
x
Reference package insert for storage requirements
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)
Rapid Micro Methods – Gram ID: Archived parameters for Gram-negative, Grampositive and Yeast/Mold isolate identification (see Appendix B)
Inhibition/Enhancement Screening (see Appendix C)
Rapid Micro Methods – Glucan (see Appendix D)
Acceptable temperature: 37º C + 1º C
Sample requirement: 25 μL sample per channel
NOTE: Sample must be delivered to each sample port without contamination or cross
contamination between samples.
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Endosafe - Portable Test System User’s Guide
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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
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Seiko Printer Cable
Epson TM-U220D Printer
Epson Printer Cable
Epson Printer Ribbon
Epson Printer Paper
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Endosafe - PTS mini pipettor
Protective reader case
®
Eppendorf * pipette tips
®
Molded cable for Epson
TM-U220D Printer
Ribbon for Epson TM-U220D
Printer
Paper rolls for Epson TM-U220D
Printer
25 μL disposable unit with + 5%
accuracy and + 3% precision at
full stroke
Solid plastic, with handle for
instruments and supplies
200 μL, individually wrapped,
validated to 0.005 EU/mL
PTS109
PTS301
PTS302
PTS310
PTS311
PTS312
PTS313
PTS400
PTS600
D100
*Eppendorf is a registered trademark of Brinkmann
Multiple patents pending.
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Endosafe - Portable Test System User’s Guide
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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.
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
Extended Warranty
IQ,OQ,PQ
On Demand Repairs
PTS500
PTS501
PTS502
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.
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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.
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. Submitting the completed card will permit the Technical
Services Department to more efficiently meet each client’s needs.
All warranty and service options are subject to the Terms and Conditions and
procedures specified in the Service Agreement. For answers to questions about any of
®
these components for the Endosafe - PTS or for additional product information, please
contact Charles River Laboratories Technical Services Department:
United States:
Europe:
Copyright 2003
PIPTS101-10
1023 Wappoo Road, Suite 43-B
Charleston, SC 29407
USA
(800) 762-7016
00 800 15 78 97 43
Page 6
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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. 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.
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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.
A.
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.
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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.
#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.
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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 Ż Ź 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
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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.
M2
M24
M25
M3
MAIN MENU
USER SETUP
4-Erase Lot Numb
5-Channel EU YES/NO
3-System Menu
M31
M331
M332
M333
TIME MENU
1-Set Time
2-12 Hour
3-24 Hour
M321
M322
M323
DATE MENU
1-Set Date
2-MON/DAY/YEAR
3-DAY/MON/YEAR
M41
M42
M43
M44
M45
M46
M47
M5
M6
M7
E.
SYSTEM MENU
1- Displ DateTime
PRINT MENU
1-Print Last Tst
2-Print All Tsts on given date
3-Print All Tsts
4-Print 40-Character format
5-#Tests Stored:
6-Printer Test
7-Erase All Recs
5-System OFF
6-System Reset
7-System Info
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.
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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.
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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.
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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.
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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. 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
screen.
12. While in progress the screen will display messages showing the
current progress.
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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.
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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.
MESSAGE
DESCRIPTION
“A2D SETUP”
“TEMP TOO LOW”
“TEMP TOO HI”
“MOTOR NOT HOME”
“CLOCK FAULT”
“Computing Error”
“Charge Battery”
“Battery Fault”
“UNKNOWN”
“One or more test LEDs out of spec”
“Abort Test CANCEL OR ENTER”
Photo A/D set up did not complete
Cartridge temperature is too low
Cartridge temperature is too high
Cannot run pump motor
Cannot read Real Time Clock
Divide by 0 or range error
Batteries too weak to run tests
Battery charging problem
Any unspecified system fault
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
“Sample Not Seen” flashes during
test
If any of these or other problems persists, contact Charles River Laboratories Technical
Service:
United States:
Europe:
1023 Wappoo Road, Suite 43-B
Charleston, SC 29407
USA
(800) 762-7016
00 800 15 78 97 43
Fax:
E-Mail:
(843) 766-7576
endo-comments@crl.com
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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.
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.
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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. 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
x
x
x
x
x
Sample EU/mL
Sample %CV
Spike EU/mL
Spike %CV
% Spike Recovery
Remove Cartridge
The PTS Reader continues to display the assay results until cartridge is removed.
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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: ........ 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
:
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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. 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
x
x
2.
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.
The PTS Reader displays “SELF TEST OK” and
the “INSERT CARTRIDGE”.
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.
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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 25μL 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.
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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.
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PIPTS101-10
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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.
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
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
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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. 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.
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)
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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 Dilution #2 Factor
Enter Dilution #3 Factor
Enter Dilution #4 Factor
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
displays:
x ADD SAMPLE; PRESS ENTER
x Pipette 25 μL 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.
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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.
Copyright 2003
PIPTS101-10
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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: ........ 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%
:
Copyright 2003
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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. 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 #
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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. Dispense the sample
Once all test information is entered, the reader
displays:
x ADD SAMPLE; PRESS ENTER
x Pipette 25 μL 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.
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.
Copyright 2003
PIPTS101-10
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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: ........ 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
:
Copyright 2003
PIPTS101-10
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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
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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.
Important! Turn off and unplug the Endosafe® – PTS instrument for all decontamination
and cleaning operations.
1.
2.
3.
Copyright 2003
PIPTS101-10
Turn off and unplug the Endosafe® – PTS instrument.
Moisten a cloth with a mild detergent solution. Do not soak the
cloth. Wipe down all surfaces of the Endosafe® – PTS instrument.
Use a clean dry cloth to dry all wet surfaces.
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