Data Acquisition System- Steri Trac

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3. ii User Adjustable Impending Alarms................... ................................................... ............ 38 General Care of the DAQ System ..................... ................................................... ............. 38 VI Troubleshooting ................................. ................................................... ............................ 40 VII Service........................................ ................................................... .................................... 42 VIII System Installation and Setup ................. ................................................... ....................... 43 Unpacking and Inspecting the System ................ ................................................... ........... 43 Setting up the System.............................. ................................................... ....................... 43 Powering up the System............................. ................................................... .................... 44 Turning off the System ............................. ................................................... ..................... 45 Cable Assembly ..................................... ................................................... ........................ 47 Initialization (.Ini) File ......................... ................................................... .......................... 48 IX Parts List and Accessories...................... ................................................... ........................ 51

18. 15 The MAIN SETUP Screen has the following fields: Installation Name: Press this field and enter your site name. If you make an error, delete characters by using the keyboard dele te key. Move from field to field by touching the screen or pressing the TAB key on the keyboard. Installation Date: Press this field and enter eith er the installation or setup date in a mm/dd/yy format. Active Areas: These blocks show active and inact ive monitor areas. For an active area, press the appropriate area block so it turns green and “Y” appears. For an inactive area, press the appropriate area block so it turns dark gray and “N ” appears. Shift Start/End Times: These fields determine the d efault time interval in Summary Reports. The DAQ clock is a “military” or 24 hour system. P ress the field adjacent to “Start Shift 1” and enter the sta rt time for your department’s first shift. Press the field adj acent to “End Shift 1” for the end time for shift 1. Contin ue until all shift times are entered. For example, if your shifts are 7:00 a.m. to 3:00 p .m., 3:00 p.m. to 11:00 p.m., and 11:00 p.m. to 7:00 a.m., en ter the following shift times: MAIN SETUP SCREEN

37. 34 Alarms Report This feature is similar to the summary report excep t that it reports only alarm conditions during the selected period. The report displays these conditions in a tabular format, with one table for action level ( blue) alarms and one table for local, EL, or PEL (red) alarms. The advantage to t his report is that if the user selects an individual alarm period [by clicking (ta pping) the appropriate row in the table], a detailed report screen appears with t he dates and times pre- entered. These reports start eight (8) hours prior to the event for PEL alarms or one (1) hour prior to the event for the remainin g alarm types. The user may accept the pre-entered values and generate the repo rt, or may change any desired report criteria prior to report generation. Once the detailed reports are viewed or printed, the tabular display is presented again to allow for selection of additional alarm periods. There is no option to print the tabular report screen – use the summary report option for hard cop y of alarm summaries.

14. 11 “ACTION LEVEL” The DAQ detects exposure that excee ds the Action Level. The area block is blue and audible alarms activate. “UNIT FAILURE” The DAQ is not detecting data from the area monitor. The area block is light gray and audible alarms act ivate. “UNIT ERROR” The DAQ has detected an error fro m the area monitor. The type of error will be displayed on the DAQ screen i n lieu of the current ppm reading. (See example below.) The e rror messages are explained below. Example of a UNIT ERROR message. In this instance t he DAQ has detected that the sensor module in Area 1 h as been removed. NO SENSOR: The sensor module has been remove d from the area monitor. SENSOR MISMATCH: The wrong type of sensor has been connected to the monitor. (e.g. an EtO sensor on an H2O2 monitor.) UNDER RANGE: The ppm reading at the area monitor is unusually low (below zero ppm), indicating a malfun ction. OVER RANGE: The ppm reading has exceeded the maximum level the area monitor is able to detect. T his level varies according to the sensor type.

45. 42 SECTION VII SERVICE For problems specific to any Area Monitor, or for D AQ specific problems, call DAQ technical assistance at: 1-800-245-3310 x310 User manuals, information on software updates, and other useful information related to sterilant gas monitoring is available on the ChemDAQ internet site at http://www.chemdaq.com

26. 23 Sensor Serial # This is the serial number of the s ensor installed in the monitor. For Steri- Trac Area Monitors the number the DAQ automatically fills in this information. For Pointgard II monitors, this must b e filled in manually. Area Comments: These fields are for Area Comments , general information about the monitor or its area. These comments appear at the end of both Summary and Detailed reports. There is a limit of 80 chara cters per line.

2. i TABLE OF CONTENTS I Introduction: The ChemDAQ™ Data Acquisition System ................................................ 1 II Principles of Operation ......................... ................................................... ........................... 2 Sampling ........................................... ................................................... ............................... 2 Alarms............................................. ................................................... ................................. 3 Records ............................................ ................................................... ................................ 5 Reports ............................................ ................................................... ................................. 6 III Startup and Operation of Your ChemDAQ System ... ................................................... ...... 8 Turning On The System .............................. ................................................... ..................... 8 The Local Area Monitors Screen ..................... ................................................... ................ 9 System Operating Status Panel ...................... ................................................... ................ 13 The Main Setup Screen .............................. ................................................... .................... 14 Update Area Monitors Screen.................................................................... ..18 Area Information Screen ............................ ................................................... .................... 22 The Comments Screen ................................ ................................................... ................... 24 IV Generating Reports .............................. ................................................... .......................... 28 Report Setup Screen................................ ................................................... ....................... 28 Report Display ..................................... ................................................... .......................... 30 V Maintenance ...................................... ................................................... ............................. 35 Setting the Date and Time.......................... ................................................... .................... 35 Automatic Data Backup .............................. ................................................... ................... 36 Manual Data Backup................................. ................................................... ..................... 36 Data Archiving..................................... ................................................... .......................... 36 Recalibrating The Monitor Touch Screen............ ................................................... ......... 37

32. 29 Start time hh:mm: Enter the start time for the de sired report. The calculator pad appears. Enter numbers in the specified format, in cluding the colon. End time hh:mm: Enter the end time for the desire d report. The calculator pad appears. Enter numbers in the specified format, including th e colon. Interval: This field relates to Detailed Reports only. An interval is the smallest unit of time displayed in the report. Ent er the desired time interval in hours and/or minutes. “00:01” is one m inute, “00:15” is fifteen minutes, and so on. For a Detailed Report s howing every stored record for a specified time period, enter “0 0:00”. For example, for a Detailed Report showing activity every 5 minutes of the first 30 minutes of shift 1, the start and e nd times are 7:00 and 7:30, respectively, and the interval is 5 minutes. Records are displayed for 7:00, 7:05, 7:10, 7:15 and so on. Presets: Selecting one of the available presets wil l enter the appropriate data into the report setup fields (for the “Last Shift” preset to be available, shift information must be entered on the Setup scre en). Once a preset is selected, the individual fields may be ch anged as desired. Notes: As stated in Section I, page 6, the DAQ stores reco rds with values less than 3 ppm at 15 minute intervals if no alarm conditions exist. If you request an interval of less than 15 minutes, the Detailed Report may include records at intervals of 15 minutes because of this storage method. The summary report is the default report. If enter ed in the setup screen, the default start and end times reflect shift times. You may enter t imes other than shift times. However, once the report is generated, the DAQ reverts to de fault shift times The forward slash (/) is used during date entry and the colon (:) is used during time entry. One button exists on the calculator panel that cha nges caption based upon the type of data entry. Leading zeros are not required to be entered. Howe ver, if a zero value is entered, at least one zero must be entered (eg.: during time entry, “ 00:01” may be entered as “0:1”). When generating a detailed report with a long inter val, an alarm that occurs and clears in between displayed times will not be displayed. It is suggested that a summary report of the time period be reviewed for alarm times during the report period.

16. 13 SYSTEM OPERATING STATUS PANEL The System Operating Status box appears on the main screen of the DAQ: The purpose of the panel is to provide an indicatio n of when your sensors are due for exchange according to the sensor exchange program. Sensor Exchange Status: The sensor exchange status indicator provides a vis ual reminder of the calibration status of the sensors in each area monitor. A green block (note areas 1 and 3 in the illustration above) indicates that the sensor’s calibration stat us is current. A yellow box (note area 4) means the sensor has rea ched 60% of its calibration interval. For instance, if the calibration interval for the s ensor is 180 days, the block will turn yellow at 120 days. The DAQ bases this calculation on the data recorded in the memory of each sensor module. A black box (note area 2) means the sensor is overd ue for calibration. If you see this indication, please contact your ChemDAQ service rep resentative. Archive Status: This gauge provides an indication of the need to ar chive data based upon the data retention amount chosen. The assumption is made th at data will be archived when the amount of data stored covers a period twice that of the programmed retention period. For example, if the program is set to retain 12 months of data when archiving, it is assumed that the archiving will be performed when 24 months of data exist in the files. A gray indicator bar will fill a percentage of the gauge b ased upon the amount of data stored. In the example above, the bar will indicate a 24 month period. The bar will be gray until 25% of the period remains, at which time it turns b lack (in the example above, when 18 months of data is stored). When the bar fills the gauge, “ARCHIVE DATA NOW” is displayed.

13. 10 LOCAL AREA MONITORS SCREEN (7 Areas shown, 1 not active. 6 Areas contain two b locks centered in second row) Below the ppm reading in each block is a message ar ea. If the unit is operational and incoming samples are below alarm levels, the message is “OK” and the current TWA averages are displayed. Other possible messages are: “CALIBRATING” The unit in this area is currently b eing calibrated. The area block is light gray. “EL *.* ” The DAQ is initializing, or building the 15 mi nute time weighted average for this unit. “PEL *.* ” The DAQ is initializing, or building the 8 hou r time weighted average for this unit. “EL IMPENDING” ] The DAQ detects a pending EL and/o r PEL alarm. ] The area block is yellow and audible alarms activ ate. “PEL IMPENDING” ] “EL EXCEEDED” ] The DAQ detects exposure that excee ds EL, PEL, ] and/or Local Alarm levels. “PEL EXCEEDED” ] The area block is red and audible alarms activate. ] “LOCAL ALARM” ]

49. 46 SECTION IX TECHNICAL REFERENCE CABLE ASSEMBLY To make cable assemblies, you will need, as appropr iate: · Wire stripper/cutter · DB-9 crimping tool. · Small flat blade screwdriver · Small Phillips-head screwdriver · Plenum cable (2 pair, minimum) · Cable connectors (see Figures D on following page for correct connectors) Instructions for Cable Assembly 1. Determine lengths of cable necessary to connect each monitoring point to the CHEMDAQ System. 2. Cut cable to determined lengths. 3. Strip outer jacket using the modular crimp tool for the remote repeater or DAQ end(s). For the monitor end, strip off approximately one inch o f the outer jacket. 4. If necessary, arrange the conductors in the desi red color order. For the monitor end, cut short any unused conductors and bare approximately one quarter inch of the remaining wires. 5. Crimp or secure wires to appropriate connector/p ins (see Figure A,B) Note: These are general instructions for cable assembly. Refer to individual equipment documentation or contact DAQ technical support for specific instructions if required.

10. 7 Detailed Reports Summary Reports give general information for a part icular time period. However, for further detail about this period, you can generate a Detailed Report. For example, if a Summary Report indicates that a s pecific area’s PEL was exceeded during a period of time, a Detailed Report can be generated to allow you to see precisely what occurred during that time. The Detailed Report has the following information: 1) Starting date of report 2) Ending date of report 3) Starting time of report 4) Ending time of report 5) Time interval requested for report 6) The specific Area in report 7) Date of record 8) Time of record 9) PPM value(s) 10) EL (15 minute average) 11) PEL (8 hour average) 12) Action Level status 13) PEL status 14) EL status 15) Local Alarm 16) Maximum ppm reading of report 17) Maximum EL of report 18) Maximum PEL of report 19) Specific Comment, if appropriate. See page 24 for a description of Specific Comments. 20) Area Comment, if appropriate. See page 23 for a description of Area Comments. Alarms Reports The Alarms Reports provides a method to find alarm conditions during a period of time and semi-automatically generate detailed reports for sp ecific alarms during the period. See Section IV, Generating Reports , pages 28 - 34 for a description of reports.

30. 27 Summary Report For the summary report, one line is used for each c omment. This line includes the comment date and time and the first li ne of the comment. Detailed Report For the detailed report, one screen is used for e ach comment. The entire comment is displayed. Note: To update or delete a particular comment, note its date and time and then press END DISPLAY to return to the Comments Screen. Enter the date and time for the comment you wish to change. Then follow the instruc tions above (page 22) to modify or delete the comment.

47. 44 3. Place the monitor in a convenient location, ensu ring that the video cable reaches the matching connector on the system unit. 4. Ensure the power switch for the UPS is OFF. Plu g the UPS into a wall outlet. Locate the power cable for the system unit. Plug one end of t he power cable into the power connector on the rear of the unit and the other end into the UPS. 5. Locate the monitor power cable. Plug this cable into the UPS. Plug the other end into the monitor. (Some monitors have a permanently attached cable.) 6. Locate the video cable. Connect one end of this cable to the display adaptor video connector on the back of the system unit. Connect the other end of the video cable to the monitor. (Some monitors have a permanently attached video ca ble.) If you encounter any difficulty making video connections, refer to t he manual supplied with the monitor before proceeding. 7. Locate the keyboard cable. Orient the end plug to mate with the notch in the system unit’s connector and plug in the cable. 8. If external speakers (or speakers integrated int o the monitor) are being used, locate the speakers and their cables. Place them in convenien t locations, ensuring that the speaker cables reach the matching connectors on the system unit. If you encounter any difficulty making speaker connections, refer to the manual sup plied with the speakers/monitor before proceeding. 9. If applicable, locate the power cable for the sp eakers. Plug one end into the power connector on the speakers and the other end into th e UPS. 11. Connect 1 to 8 CHEMDAQ Modular Interface Cables into the CHEMDAQ serial interface jacks. 12. To connect the printer, first locate the printe r interface cable. Connect one end to the printer and the other end to the rear of the system unit. Locate the printer power cable. Plug one end of th is cable to the UPS and the other end into the printer. (Some printers have a permanently attached cable.) If you encounter any difficulty making printer connections, refer to the manual supplied with the printer before proceeding. POWERING UP THE SYSTEM Refer to Section III Startup and Operation of Your CHEMDAQ System , Page 8, for instructions to start the system.

9. 6 10) Initialization status 11) Local Alarm status 12) Failure status As noted in the "Calibration" discussion under “Sam pling” page 2, the DAQ does not include calibration values in time weighted averages. Howe ver, the DAQ continues to receive and store ppm values during calibration and flags the record appropriately. This function documents calibration values, dates, and times for each unit. The DAQ collects and calculates average ppm exposur e every 20 seconds. In the event of an alarm condition, the DAQ stores the records in 20 s econd intervals until the alarm subsides. In addition, if levels are ≥ 3 ppm, the DAQ also stores the records in 10 secon d intervals. However, if levels are below 3 ppm and no alarm condition ex ists, records are stored in 15 minute intervals. This conserves data storage space in the system. REPORTS The DAQ combines stored data records into reports . You can review records by generating three types of repor ts: Summary, Detailed, and Alarms. Summary Reports The Summary Report is an overview of a specific time period, either a preset shift time or requested interval, for a specific Area Monitor uni t or all units. This report includes the following information: 1) Starting date of report 2) Ending date of report 3) Starting time of report 4) Ending time of report 5) Area number 6) Time periods in which the following conditions a re exceeded: Action Level PEL EL Local Alarm 7) Calibration times and dates if calibration occur red during report time. 8) Failure times and dates if unit was non-operatio nal. 9) Informational message if PEL initialization occu rred during report time. 10) Informational message if area that EL initializ ation occurred during report time. 11) Area Comment, if appropriate. See page 23 for a description of Area Comments.

48. 45 TURNING OFF THE SYSTEM To prevent data loss, it is highly recommended that the DAQ software be terminated and Windows be exited prior to system shutdown. To terminate the DAQ software, press the EXIT THE SYSTEM button in the MAIN SETUP screen, then confirm exit. Once the program is terminated, press the Start Men u button, then press “Shutdown”. Select the appropriate shutdown option and press OK Windows will shutdown and, on most systems, turn of f the PC. If the PC does not turn off, press the power button when Windows indicates that it is safe to turn off the computer. It may be necessary to hold the power button down for several seconds on some systems. Then, turn off the monitor, printer, and all access ories.

54. 51 SECTION X PARTS LIST AND ACCESSORIES Description Part Number Steri-Trac™ Monitor Body- Ethylene Oxide ST1-EMON Steri-Trac™ Monitor Body- Hydrogen Peroxide ST1-HMO N Steri-Trac™ Monitor Body- Ozone ST1-OMON Steri-Trac™ Remote Mounted Sensor Kit ST1-RSM Steri-Trac™ Remote Display Ethylene Oxide: ST1-ERD Hydrogen Peroxide: ST1- HRD Ozone: ST1-ORD Steri-Trac™ DAQ Package Incl.: Computer, ChemDAQ Software, Printer ST1-DAQ Remote Video Display ST1-RVD Steri-Trac™ to 9 pin serial port Cable Contact Chem DAQ Steri-Trac™ Configuration Software Contact ChemDAQ

42. 39 Environmental Considerations For adequate ventilation, place the DAQ where air c an freely circulate and avoid locations with high levels of dirt, dust, or smoke. Never block the rear panel cooling fan port or stac k papers or books on top of the video monitor. Do not place the DAQ in direct sunlight or near hea ters or lamps. Cleaning To prevent dust accumulation, occasionally wipe the monitor, case surfaces, and keyboard with a soft, dry cloth. For more extensive cleaning, wipe surfaces with a damp, lint-free cloth. An inexpensive keyboard vacuum may be used to remove d ust from the keyboard. Use a soft cloth and antistatic cleaner to clean the monitor screen. DO NOT ALLOW WATER OR ANY LIQUID TO ENTER OPEN VENTS. Spillage If you spill liquid inside the keyboard, unplug the keyboard immediately and drain the liquid. Let the keyboard dry overnight before using it again. A keyboard skin should be installed if liquid spills are likely. Transporting the System Dropping or jarring the system can damage the hard disk, particularly during access, and loosen system circuit boards. Always turn off the system before moving it. During transport, pack the system in appropriate padding within the packing ca rtons.

44. 41 6) The DAQ shows UNIT ERROR. -- Note the error message displayed on the DAQ: NO SENSOR: The sensor module has been removed from the area monitor. Replace the sensor module. SENSOR MISMATCH: The wrong type of sensor has been connected to the monitor. (e.g. an EtO sensor on an H2O2 monitor.) Install th e correct sensor module. UNDER RANGE: The ppm reading at the area monitor is unusually low (below zero ppm), indicating a malfunction. Contact your ChemDA Q service representative. OVER RANGE: The ppm reading has exceeded the maximu m level the area monitor is able to detect. This level varies according to t he sensor type. Contact your ChemDAQ service representative 7) When there’s power failure or institution testing o f power, the DAQ loses data. -- The DAQ reinitializes and resumes normal operati on following power failure. However, as with any PC, power failures - or surges - may result in loss of previous data. -- See Electrical Protection recommendations in Section V Maintenance, page 38.

46. 43 SECTION VIII SYSTEM INSTALLATION AND SETUP UNPACKING AND INSPECTING THE SYSTEM When your DAQ system arrives, check the shipping ca rtons for wrinkled or damaged corners, holes, or other signs of rough handling. Ask the d elivery service to note any damage on the delivery receipt. Carefully remove the computer system, keyboard, acc essories, and manuals from the shipping cartons. Remove the video monitor, video cables, p ower cable, and instruction manual from the monitor box. Place all equipment on a table and inspect each ite m. Report any damage to the carrier immediately. Check received items against the packing list found on the outside of the shipping carton. Make sure you have received all items on the packing lis t. Save all packing materials so that you can safely r epack the system for transport. Cold Weather Precautions If your system arrives in very cold weather, allow the cartons to warm to room temperature for several hours before opening. Exposing a cold comp uter to a warm room causes condensation that could damage the system. If condensation does form, let the system dry overnight before proceeding. SETTING UP THE SYSTEM To set up the system for the first time, you will n eed: · Large, uncluttered table with nearby grounded pow er outlet; · Small flat-blade screwdriver; and · Small Phillips-head screwdriver 1. Familiarize yourself with the front and back of the monitor and system unit and to the general recommended power configuration. 2. Put the system unit on the table. Make sure the line voltage selector on the rear panel, if applicable, is set correctly (115VAC in the U.S. an d Canada). Connecting peripherals while the power is on can damage the system.

17. 14 THE MAIN SETUP SCREEN To maximize storage and retrieval features of the D AQ, it is important to enter specific information about all Area Monitors. This informat ion is entered in the MAIN SETUP screen. To move to this screen, press SETUP on the LOCAL AREA MONITORS screen. A small calculator pad appears. Enter the factory default password provided with your unit by pressing on the key pads (for security, “*” will appear for each digit). Then press OK . DAQ CALCULATOR

25. 22 AREA INFORMATION SCREEN This screen documents specific information about ea ch Area Monitor unit and its sensor. To open this screen, press GO BACK to return to the LOCAL AREA MONITORS screen. Pres s the AREA 1 (or other desired area) block. The foll owing menu appears: Press AREA 1 INFORMATION . The following screen appears: Area Information Screen. Complete these fields: ( Note: These fields are for informational purposes only a nd do not affect the performance of your area monitor.) Unit Serial # This information is found on the Ar ea Monitor unit. Location: Physical location of Area 1 monitor. T his information appears in the Local Area Monitors Screen area block.

6. 3 Calibration: During monitor calibration (or sensor exchange), the user places the DAQ system in calibration (sensor replacement) mode. T he Action Level and PEL 8 hour TWA average calculations are suspended f or up to 30 minutes. If calibration concludes within 30 minutes, the av eraging is resumed using initial post-calibration ppm values. However, if ca libration exceeds 30 minutes, the DAQ reinitializes 8 hour TWA averaging for that unit. The EL TWA 15 minute average calculations are also suspended when the monitor is being calibrated. Upon completion of th e calibration, the DAQ always reinitializes 15 minute EL TWA averaging for that unit. Unit Failure/ Unit Error: Action Level and PEL averaging is suspe nded during a unit failure for up to 30 minutes. If a unit resumes normal operation within the 30 minute period, the averaging is resumed using initial post -failure ppm values. If a unit failure exceeds 30 minutes, the DAQ reinitiali zes averaging for that unit. The EL TWA 15 minute average calculations are also suspended during a unit failure. Upon return to operation, the DAQ al ways reinitializes 15 minute EL TWA averaging for that unit. ALARMS Visual Alarms The DAQ displays text within a color block system f or quick visual identification of the status of individual monitors and alarm conditions. This sys tem is as follows: Dark Gray: Area is not activated in DAQ Setup Scree n. Green: Unit is active (normal operation). Light Gray: Unit is being calibrated, Or there is a "Unit Failure" Alarm : This alarm activates when there is monitoring failure, i.e. interruption in the flow o f monitoring data from the individual Area Monitor unit to the DAQ. Or there is a “ Unit Error .” This alarm activates when the DAQ detects an error with one of the Steri-Trac™ monitors. For ins tance, removing the sensor module from the area monitor will trigger a “ Unit Error ” alarm as will connecting the wrong gas-type sensor module to an area monitor (e.g. connecting an H202 sensor module to an EtO monitor) .

21. 18 Press the START SENSOR REPLACEMENT button immediately prior to changing the sensor in the designated monitor. The DAQ returns to the Local Areas Monitor screen. The area block for the calibrating unit turns light gray and displays the text “END SENSOR REPLACEMENT.” When the Area Monitor reading is stable, return to the MAIN SETUP Screen. Press the END SENSOR REPLACEMENT button. The parts history (see below) information for the replaced sensor will automatically be updated by th e program. A comment is automatically added noting sensor replacement. Repeat this sequence until all desired Area Monitor s’ sensors are replaced. UPDATE AREA MONITORS The UPDATE AREA MONITORS screen (shown below, indic ated by the arrow) is accessed by pressing the SET-UP button on the main screen, t hen pressing the USER SETTINGS button on the MAIN SETUP screen. Note: As stated in Section I, page 3, PEL averaging prior to calibration is suspended during replacement for up to 30 minutes . If this time limit is exceeded, the DAQ reinitial izes PEL averaging for that unit. During sensor replace ment, the MAIN SETUP screen will display a message “Before ‘ending’, allow 2 minutes after replacement for stabilization.

31. 28 SECTION IV GENERATING REPORTS To create a report, press the REPORTS button on the LOCAL AREA MONITORS screen to open the REPORT SETUP screen. You may also open th is screen by pressing the specific area block for which you want a report. When the area m enu appears, press AREA REPORTS . REPORT SETUP SCREEN The Report Setup Screen includes the following fiel ds. Place the cursor by pressing on the field or by using the TAB key. If the message “RETRY” ap pears in the field, reenter information in the correct format. Area(s) To Report: The default is “0” if the REPORTS button was pressed, or the specific area selected if the AREA REPORTS button was pressed. An entry of “0” creates a report for all areas. If desired, press the field to select a different area. Start date mm/dd/yy: Enter the start date for the desired report. The calculator pad appears. Enter numbers in the specified format, in cluding the forward slashes. End date mm/dd/yy: Enter the end date for the desi red report. The calculator pad appears. Enter numbers in the specified format, including th e forward slashes.

50. 47 Figure A. CONNECTORS Instrument CHEMDAQ DAQ Steri-Trac Monitor Connector: description DB9 Female Screw Type Terminal Connector: Pin information (RS485) 1 Data - 2 Data + 3 x 4 x 5 GND 6 x 7 x 8 x 9 x X=no connection As Labeled Figure B. SYSTEM CABLE ASSEMBLIES

23. 20 for that area. The gas-type setting ensures that th e DAQ displays the correct gas type on the main screen. Important Note: In order for your area monitor to d etect a specific gas, it must be equipped with the sensor specifically desig ned for that gas. Simply changing the gas type at the DAQ will not, for instance, all ow an EtO sensor to detect H2O2. The Update Area Monitors screen. Note: The remaining settings only apply to Steri-Trac mo nitors: Use the MONITOR ADDRESS field to enter the monitor’ s unique address. Press on the field and a cursor will appear. Use the keyboard to type in the address. Note: Each Steri-Trac Area Monitor has its own unique add ress programmed into its memory during production. The address is identical to the monitor’s serial number printed on the customer care label you will find attached to the s ide of the monitor. It’s a twelve digit serial number. The 9 th digit is always an ‘M.’ Type this serial number in to the MONITOR ADDRESS field. This address is required by the RS-485 data protoco l used by the Steri-Trac Area Monitors. This is how the DAQ knows where to ‘find’ each moni tor.

1. DATA ACQUISITION SYSTEM Operation Manual and Installation Guide WARNING THIS MANUAL MUST BE CAREFULLY READ BY ALL INDIVIDUA LS WHO HAVE OR WILL HAVE THE RESPONSIBILITY FOR INSTALLING, USING, OR SERVICING THIS PRODUCT. LIKE ANY PIECE OF COMPLEX EQUIPMENT, THIS PRODUCT WILL PERFORM AS DESIGNED ONLY IF INSTALLED, USED AN D SERVICED IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS. O THERWISE, IT COULD FAIL TO PERFORM AS DESIGNED AND PERSONS WHO R ELY ON THIS PRODUCT FOR THEIR SAFETY COULD SUSTAIN SEVERE PERSO NAL INJURY OR DEATH. The warranties made by ChemDAQ Incorporated with re spect to these products are voided if the products are not installed, used and service d in accordance with the instructions in this manual. Please protect yourself and others by following them. We encourage our customers to write or call regarding this equipment prior to use or for any additional information relative to use or repairs. Customer Service: 412-787-0202 or 800-245-3310, e xt. 310 FAX: 412-788-2526 EMAIL: techsupport@chemdaq.com © ChemDAQ Incorporated 2008 – All Rights Reserved ChemDAQ Incorporated 135 Industry Drive Pittsburgh, PA 15275 http://www.chemdaq.com 1/2008 809088 TM

15. 12 REPORTS SILENCE ALARM SETUP The Reports button opens menus for generating repor ts. See Section IV, Generating Reports , pages 28 - 34 for a description of this function. The Silence Alarm button silences an active alarm a nd is visible when an alarm is activated. This option is described in “M ain Setup Screen” in this section on page 13. The DAQ Clock For instructions on setting the digital clock dis play, please see “Setting the Date and Time” in Section V, Maintenance , page 35. The Setup button opens the MAIN SETUP screen. A des cription of this screen follows. To minimize the possibility of monitor burn-in (eve n LCD panels may experience a form of burn-in), the ChemDAQ Monitoring System supports th e use of a custom screen saver. When active, the screen saver displays area information in condensed form on a black background. The area boxes scroll up and down the full height of th e screen to avoid burn-in. For each area, the area number, current ppm, and status bar are displa yed. The screen saver will deactivate upon a touch of the screen or any keyboard input (since to uching the screen can open various other windows, we recommend touching the lower right port ion of the screen or pressing either shift key on the keyboard to deactivate the screen saver) . In the event of an alarm in any area, the screen sa ver is automatically disabled for the duration of the alarm. In addition, the screen saver is disabl ed during any backup operations (this ensures that the backup process is completed as quickly as possible). Note: If a "red block" alarm condition occurs and then su bsides, the DAQ returns the appropriate area block to green (normal operation) but highlights the warning in red. This highlighted warning indicates a recent alarm. By generating a Detailed Report, the user can determine ppm levels for the duration of t he alarm. To cancel this warning message without generating a report, press the area block. The AREA submenu appears. Press GO BACK. This action clears the highlighted warning message.

27. 24 THE COMMENTS SCREEN If there is an alarm condition, unit failure, or an y type of unusual occurrence in a specific area or in all areas, you may want to record comments to ex plain the occurrence. These comments are entered in the screen accessed by the COMMENTS button located in the MAIN SETUP screen. Press the COMMENTS button. The following screen appears: COMMENTS SCREEN To Create a New Comment Enter the date and time for the comment documenting this event. Comments appear in reports identified by this date and time. Refer to Section IV GENERATING REPORTS , Pages 28 - 34 for a description of how comments are displayed in reports. Enter your comment in the center block of the screen. There is a limit of 60 charac ters per line and ten lines per comment. Press the area box corresponding to the area or are as to which this comment applies. Depending upon your system configuration, either four or eigh t area boxes will be available. If the comment describes a system wide event (for example, a depar tmental power fluctuation or loss), press the box adjacent to “ALL.” Press ADD to save the new comment. A message appears if the date/time format is incorrect or if area selection is omitted.

12. 9 THE LOCAL AREA MONITORS SCREEN The LOCAL AREA MONITORS screen is the main operatin g screen. It displays data received from individual monitors. Area Blocks Data from up to eight Area Monitors simultaneously display in blocks designated as “Area 1,” “Area 2,” “Area 3,” and so on. Normally, green blo cks indicate active local monitors while dark gray blocks indicate inactive or no monitors. Depen ding upon the maximum number of areas that can be monitored with your system, either four, six , or eight blocks will be displayed on the screen. Notes: Touch screen control facilitates movement within a screen or between screens by touching the desired button, area, or field on the screen. For accurate touch control, sit directly in front of the monitor and lightly press on the screen. Pressing the TAB key on the keyboard also moves the cursor from field to field for text entry or to buttons for activation using the ENTER key. LOCAL AREA MONITORS SCREEN (4 Areas)

28. 25 To Change a Comment Enter the date and time for the comment you wish to change. Once the date and time are entered, press VIEW . The UPDATE button appears. Enter your change(s) and press th e update button. This stores the revised comment. To Delete a Comment Enter the date and time for the comment you wish to delete. Press VIEW . Press the DELETE COMMENT icon. You cannot retrieve deleted comments. To Review Entered Comments To prepare a report of all comments in a specific time period, press the icon “View Comments by Date Range.” A window appears to enter the dat a for the comment report.. COMMENT REPORT SETUP Area(s): Touch to check the boxes for the areas t hat you wish to view comments. If you wish to view comments for all areas, touch to check the ALL box.

43. 40 SECTION VI TROUBLESHOOTING 1) The DAQ suddenly exits to the Windows environment. Please see instructions on returning to the DAQ in Section V Maintenance , page 35. If the DAQ exits with a General Protection Fault, i t is recommended that the system be restarted. If this happens repeatedly following a particular c ommand or sequence of commands, call DAQ Technical Assistance. See page 42. 2) The touch screen is misaligned. -- Make sure that you are sitting directly in front of the monitor. -- See instructions “Recalibrating the Monitor Touc h Screen” in Section V, Maintenance, page 37. 3) Area Monitor readings are different than DAQ rea dings. -- There is a slight delay as the DAQ polls current readings from the individual Area Monitors. The DAQ updates its readings every 20 se conds. 4) The DAQ will not accept password. -- Make sure you enter the correct password and pre ss “OK.” If you are using a user- defined password and it continues to be rejected, c all your ChemDAQ service representative who can assist you. Then reset the u ser password in the MAIN SETUP screen. 5) The DAQ shows a unit failure. The UNIT FAILURE message indicates the DAQ computer is not receiving data from the area monitor. -- Check to see if the area monitor is powered up and displaying a ppm reading. If not, the problem is with the area monitor. Refer to the monitor manual or contact a ChemDAQ technician. -- Check all cables and connections between the mon itor and the DAQ. -- For a Steri-Trac Monitor, verify that the correc t monitor address has been entered in the AREA MONITOR UPDATE screen. See p.20. Note: See the “Troubleshooting Guide” in the Area Monitor manual for problems specific to the type of monitor(s) being used.

34. 31 Detailed Report On the screen, the detailed report uses the same c olor coding for the reported data that is used in the area blocks. Green is use d for normal data, grey for initialization or unit failure, blue for action lev els, and red for alarm conditions. Impending conditions are not logged si nce these are used for early warning of a possible alarm condition if conditions are not corrected. If your system has a color printer, the color coding is als o used on the printout. If the printer only prints in black, the following codes a re placed in the data column or beside the applicable ppm level: F Unit failure C Area monitor being calibrated A Action Level exceeded (PEL column only) * Alarm Level Exceeded The report header contains the area information, re port start date and time, and report end date and time. The report then consists of four data columns. The first column is the date and time of the record. T he next column is the current reading at that time. The next two columns display the TWA EL and PEL calculated values, respectively. Any specific comm ents entered for the area are displayed above the first record with a date an d time ≥ the comment date and time. At the bottom of the report, the maximum value of each of the ppm data records within the report period is listed. F inally, if there is an Area Comment entered, it is included at the bottom of th e report. SUMMARY REPORT FOR: UNIT #: 01, Sterili zer Area Start Date: 04/05/08 End Date: 04/06/08 Start Time: 07:01 End Time: 15:00 __________________________________________________ ____________________ Action level: 04/05/08 @ 07:03 to 04/05/95 @ 08:3 3 Local alarm: 04/05/08 @ 11:50 to 04/05/95 @ 11:5 0 EL exceeded: 04/05/08 @ 12:00 to 04/05/95 @ 12:2 0 The above entries are in order by end time. __________________________________________________ ____________________ __________________________________________________ ____________________

20. 17 User Settings Archive Data GO BACK EXIT THE SYSTEM about a specific event in a local area. These comme nts are entered and retrieved based on time and date of the event. Please see Section IV Generating Reports, pages 28 - 34, for a description of this screen. Press this button to input user settings for the im pending alarms, automatic data backup enabling, mono/color printer selection, Sensor Exchange Program (SXP) enabling, and configuring the area monitors. Press this button to display the data archive windo w which controls archiving of older monitoring data onto th e backup media. Please see Section V Maintenance , page 35. Press this button to return to the previous screen. This button opens a series of commands that ends th e DAQ application. SENSOR REPLACEMENT -- From the MAIN SETUP Screen: When you replace a sensor through the SXP, you shou ld suspend DAQ averaging (and alarms) for that unit until the monitor is returned to normal service and the sensor reading is stable. Refer to the appropriate section below. Press the “Area” field to specify the area for sens or replacement. “1” represents Area 1, “2” represents Area 2, and so on. CAUTION: If, at any time, you inadvertently exit the DAQ app lication, follow these steps to return to the DAQ: 1) Tap the “Start” button on the lower left of the scr een, press the keyboard button with the Windows icon, or press Ctrl-Esc. 2) Tap “Programs,” then tap “ChemDAQ Monitoring.” 3) Tap “ChemDAQ Monitoring System.” This reopens the DAQ application. Note: On Windows XP systems, a shortcut for “ChemDA Q Monitoring System” should be available directly on the “Start Menu.” DAQ alarms are inactive while the program is not ru nning. Individual Area Monitors continue to monitor their respective areas, locally alarming in the event of excessive ppm exposure.

22. 19 Use the UPDATE AREA MONITORS screen to configure yo ur area monitors. For each area you can the select the type of monitor (Steri-Trac or Pointgard II), the gas type being detected (EtO or H202), and the communications port the area monitor is linked to. For Steri-Trac Area Monitors this is where you enter the address o f the monitor. (The Steri-Trac area monitors use the RS-485 data protocol which require s assigning the area monitor its own unique address.) You can also use this screen to ea sily change certain settings at the area monitor (Steri-Trac only): Alarm levels, altitude, acknowledge settings, and latching settings. Each is explained below. The first item you will see on the UPDATE AREA MONI TORS screen is a row of AREA buttons shown below. The sample below represents a DAQ with four active areas (represented by the black numbers). Buttons are sho wn active if those areas have been activated using the ACTIVE AREAS indicator on the M AIN SET-UP SCREEN. (See p.15) To change the settings of a particular area monitor , press the corresponding button. (The example above shows Area 2 selected.) Then change t he values as described below. Note: Once you change any configuration values for a spec ific area, you must press the UPDATE button to apply the changes before going to anothe r area or leaving the UPDATE AREA MONITORS screen. Otherwise your changes will be lost. Use the drop down menu to select which of the DAQs COMMUNICATIONS PORTs the area monitor is using. Your ChemDAQ technician will set this during installation. Note: In the event you need to set the communications por t yourself, here’s how you can determine which communications port the area monitor is linke d to. Press the Windows™ (  ) key on your keyboard. (Lower left of the keyboar d.) When the Start Menu appears press the CONTROL PANEL icon twi ce. (If the Control Panel icon is not visible, press the SETTINGS icon first and look for it there.) In the Control Panel window press the SYSTEM icon twice. When the System Properties window appears press the HARDWARE tab. Press the DEVICE MANAGER button. You will see a list of hardware devices. Find PORTS (COM & LPT) and press the + to open the list. In the list of ports look for the device which your monitor is con nected to (e.g. PCI serial card or RS-485 card.) The communications port #1 will be indicated by COM1, port #2 by COM2 etc.) If you are unable to determine which port your area monitor is using, please call technical support department at ChemDAQ for assistance. Use the drop down menu to select the MONITOR TYPE a nd the GAS TYPE being detected.

24. 21 Use the ALTITUDE field (see illustration below) to enter the approximate altitude in feet above sea level of your facility. The DAQ will send this figure to the area monitor and will be used by the monitor to calculate detected gas le vels. To enter the altitude simply press on the ALTITUDE field so that the cursor appears. Then use the keyboard to enter the value in feet above sea level . Note : When you enter the sea level value, the DAQ may a djust the number slightly. This is normal and is simply the r esult of computational rounding. Remember, before leaving this screen, you will need to press the UPDATE button for the change to be applied. ChemDAQ’s Steri-Trac system now allows you to set t he alarm level for each monitor from your DAQ computer. You may set the LOW ALARM and HIGH ALARM levels of each Steri-Trac monitor by touching the appropriate fiel d. (See illustration below.) When the cursor appears, type in the desired alarm setting. The DAQ will send this value to the Steri- Trac monitor when you press the UPDATE button. Example: If you enter a 5 into the low alarm field, the area monitor will sound its alarm when it detects 5ppm of the target gas. You may also adjust the LATCHING and ACKNOWLEDGE se ttings of each Steri-Trac area monitor. If LATCHING is checked, once the area moni tor alarms it will continue to alarm even after the target gas drops below alarm level. The alarm is “latched” into an active state. The alarm will silence only when you press the ackn owledge button on the area monitor. If LATCHING is not checked, then the monitor will auto matically stop alarming once the target gas drops below alarm level. If ACKNOWLEDGE is checked (recommended), then you c an silence the alarm by pressing the monitor’s acknowledge button even if the gas is still above alarm level. If ACKNOWLEGE is not checked, you cannot silence the monitor as long as the gas level remains above alarm level. Remember, before leavin g this screen you will need to press the UPDATE button for the change to be applied.

52. 49 AutoBackup= 0 | 1 This entry specifies whether the system will automa tically backup data files at 00:01 hrs each day. The default value for this set ting is 1, autobackup enabled. BackupCommandString= filename [command line parameters] BackupCommandString= DIRECT driveletter This entry specifies the complete path to any neces sary backup software and the associated command line parameters to be passed to that software to perform a normal data backup. The value of this entry is depe ndent upon the type of backup device installed in the system and the specific sof tware used to operate the device. If a high capacity removable media device (ZIP or Flash media) is used for backup, the second format listed is used to specify that the backup method is a “direct” file transfer to a secondary drive and the letter of that drive. ArchiveCommandString= filename [command line parameters] ArchiveCommandString= DIRECT driveletter This entry specifies the complete path to any neces sary backup software and the associated command line parameters to be passed to that software to backup the archive files. The value of this entry is dependen t upon the type of backup device installed in the system and the specific software u sed to operate the device. If a high capacity removable media device (ZIP or Flash media) is used for backup, the second format listed is used to specify that th e backup method is a “direct” file transfer to a secondary drive and the letter of tha t drive. Printer= Mono | Color This entry specifies the type of printer attached t o the system. It is used to determine whether a color or black printout is used for the detailed report. ScreenCalExe = filename This entry specifies the full filename, including p ath if not a control panel applet, of the screen calibration utility. If the utility is a control panel applet, the entry is in the form: ScreenCalExe=control.exe appletname .cpl ELImpInterval= numeric value (minutes) This entry specifies the time interval, in minutes, used to calculate the EL impending condition alarm. A value of 7.5 indicate s that the concentrations will be averaged over the latest 7.5 minute period.

19. 16 Change User Password Calibrate Screen Date/Time COMMENTS Start Shift 1: 07:00 End Shift 1: 14:59 Start Shift 2: 15:00 End Shift 2: 22:59 Start Shift 3: 23:00 End Shift 3: 06:59 Alarm Silence Time: The DAQ audible alarms ring fo r the duration of the alarm condition. Pressing the SILENCE ALARM button will silence the audible alarm for a preset time period. This field is used to set this time period (see note). Press this field and enter desired alarm silence ti me in 1 to 59 (minutes). Backup Data Now: Press this icon to initiate an im mediate backup of all data files. Please see “Manual Data Backup” in Section V Maintenance , page 35. The DAQ default password is provided with the syste m . You must enter this default to open the Main Setup Screen for the first time. However, you may enter your ow n password from the Main Setup Screen for added syste m security. Either your password or the default will access the DAQ system. Press this button to enter and verify a new numeric password. There is a limit of 8 digits. This button runs the Touch Screen calibration progr am. Refer to Section V Maintenance , page 37, for screen recalibration instructions. Press this button to run the Windows date and time accessory. Refer to Section V Maintenance , page 35, for instructions to set the date and time. Press this button to open a screen for entering com ments Note: An active audible alarm is silenced for this preset time when you press the SILENCE ALARM button that appears on the main screen during an alarm. However, if another alarm occurs during the alarm silence mode, the new alarm overrides the silence mode and an audible alarm activates.

5. 2 SECTION II PRINCIPLES OF OPERATION SAMPLING The Data Acquisition System (DAQ) continuously rece ives gas concentration readings in parts per million (ppm) from all Area Monitor units. Eve ry 20 seconds the DAQ averages these readings and compares the results to three OSHA lev els: the Action Level, Permissible Exposure Limit (PEL), and the Excursion Limit (EL). OSHA sp ecifies the same PEL for both EtO and H 2 O 2 . Although OSHA does not specify an Action level o r EL for H 2 O 2 , the DAQ assumes the same levels as for EtO. The Action Level is an 8 hour time weighted average (TWA) of 0.5 pp m. This means that for any 8 hour period, the average exposure level s hould be less than 0.5 ppm. The Permissible Exposure Limit (PEL) is an 8 hour time weighted average (TWA) of 1.0 ppm. This means that for any 8 hour period, the av erage exposure level must be less than 1.0 ppm. The Excursion Limit (EL) is a 15 minute time weighted average (TWA) of 5.0 ppm. This means that for any 15 minute period, the average ex posure level must be less than 5.0 ppm. The DAQ’s rolling TWA means that every 20 seconds a new and current average is calculated and tested against each standard. For example, for the Excursion Limit (EL), the DAQ reviews all readings obtained within the last active 15 min ute cycle. It then calculates an average for that cycle and compares that average to the EL. If the average exceeds the EL, the DAQ alarms. The DAQ then obtains the next sample and calculates the average for the “new” 15 minute cycle which now includes this most current sample. It co mpares that average to the EL, moves on to the next sample, and so on. The same principle appl ies to the Action Level and PEL; however the “moving window” is 8 hours instead of 15 minutes. In addition, the DAQ calculates TWA averages for impending alarm conditions. By default, the DAQ calculates a 7-1/2 minute TWA for the EL and al arms if this average indicates that exposure may exceed the EL. Likewise, the DAQ calculates a 4 h our TWA for the PEL and alarms if this average indicates that exposure may exceed the PEL. Both the time period and ppm level for the impending alarms are user adjusta ble. Exceptions to this method of monitoring occur durin g: Initialization: This is the time needed to build t ime weighted averages. For the EL, this is normally the first 15 minutes of operation; no valu e for the EL displays during this time. For the Action Level and PEL, thi s is normally the first 8 hours of operation; no values for the Action Level and PEL display during this time. During the initialization period, the D AQ receives and displays ppm readings from the Area Monitor unit(s) and alar ms if Local Alarm levels are exceeded or a failure of the unit is sen sed.

53. 50 ELImpSetting= numeric value (ppm) This entry specifies the concentration, in ppm, use d to calculate the EL impending condition alarm. A value of 5.0 indicates that the impending alarm will actuate if the average concentration in the latest interval sp ecified above exceeds 5 ppm. PELImpInterval= numeric value (hours) This entry specifies the time interval, in minutes, used to calculate the PEL impending condition alarm. A value of 4.0 indicate s that the concentrations will be averaged over the latest 4 hour period. PELImpSetting= numeric value (ppm) This entry specifies the concentration, in ppm, use d to calculate the PEL impending condition alarm. A value of 1.0 indicate s that the impending alarm will actuate if the average concentration in the la test interval specified above exceeds 1 ppm. Area x ComPort= numeric value (where x is an area number) The CHEMDAQ system incorporates default RS232 port IDs for each area. If hardware configurations necessitate, these assignme nts may be altered by including the appropriate setting in the .INI file. For example, a value of Area1ComPort=4 will assign COM4 to the DAQ area 1. Area x MonitorType= numeric value (where x is an area number) These settings can be changed within the Set-up/ Us er Settings screen within the ChemDAQ program. 4 Pointgard II EtO 5 Pointgard II H 2 O 2 6 Steri-Trac EtO 7 Steri-Trac H 2 O 2 Monitor Address: This is the RS485 address of each Steri-Trac monit or. Do not alter these entries. The monitor addresses can be e dited on the MONITOR SETUP screen. See p.#*

29. 26 (S)CREEN OR (P)RINTER (D)ETAIL OR (S)UMMARY START REPORT Start date mm/dd/yy: Enter the start date for the d esired report. The calculator pad appears. Enter numbers in the specified format, including th e forward slashes. End date mm/dd/yy: Enter the end date for the desir ed report. The calculator pad appears. Enter numbers in the specified format, including th e forward slashes. Start time hh:mm: Enter the start time for the des ired report. The calculator pad appears. Enter numbers in the specified format, including th e colon. End time hh:mm: Enter the end time for the desired report. The calculator pad appears. Enter numbers in the specified format, including th e colon. Press this button to display an “S” if you want to view the report on the screen, or “P” if you want to print the report. The default setting is “S.” Press this button to display a ”D” if you want a De tailed Report, or “S” if you want a Summary Report. The default sett ing is “S.” Press this button to create the report. Report Display If the report is directed to the screen, the first page will display immediately upon completion of the report generation. If the report is longer tha n one screen page, press the VIEW NEXT PAGE button to scroll forward through the report. Press the DISPLAY AGAIN button to restart the display at the first screen page. The PRINT DISPLAY button will send the current screen display to the print spooler. To allow multiple screen pri nts per page, the printout does not start until the END DISPLAY button is pressed to exit the report display mode. If the report is directed to the printer, the START REPORT button is displayed upon completion of the report generation. Ensure that the printer is online and that sufficient paper supply is available for the report; then press the start repo rt button. Notes: The forward slash (/) is used during date entry and the colon (:) is used during time entry. One button exists on the calculator panel that cha nges caption based upon the type of data entry. Leading zeros are not required to be entered. Howe ver, if a zero value is entered, at least one zero must be entered (eg.: during time entry, “ 00:30” may be entered as “0:30”).

7. 4 Yellow: "PEL Impending" Alarm, or "EL Impending" Alarm: Based on the user adjustable TWA settings, this ala rm activates when the unit may exceed PEL and EL, respectively, if current exposur e levels continue. Blue: "Action Level" Alarm : Based on the 8 hour TWA, this alarm activates when current exposure exceeds the Action Level. Red: "PEL Exceeded" Alarm : unit exceeds PEL, based on 8 hour TWA. "EL Exceeded" Alarm : unit exceeds EL, based on 15 minute TWA. " Local Alarm" : unit’s local alarm is active. Audible Alarms In addition to visual alarms, the DAQ features the following audible alarms: Recurrent 2-beep series Alarm: Action Level is exceeded Recurrent 5-beep series Impending Alarm: PEL or EL may be exceeded Recurrent 10-beep series Alarm: PEL or EL are exceeded; or unit is failed; or unit ’s local alarm is active. Audible alarms continue for the duration of the ala rm condition unless the user activates the alarm silence. However, if another alarm occurs dur ing the alarm silence mode, it overrides the silence and an audible alarm activates. The alarm silence mode also deactivates if the alarm condition continues beyond the preset alarm silence time interval. Note: If a Red alarm condition occurs and then subsides, The DAQ returns that unit’s block to active (green) status but hig hlights the warning in red.

33. 30 (S)CREEN OR (P)RINTER (D)ETAIL, (S)UMMARY, OR (A)LARM START REPORT CANCEL Press this button to display an “S” if you want to view the report on the screen, or “P” if you want to print the report. The default setting is “S.” This field does not apply to the A larms Report. Press this button to display a ”D” if you want a De tailed Report, “S” if you want a Summary Report, or “A” to find an d report on Alarm Periods. The default setting is “S.” Press this button to create a report. Press this button to cancel entered data This retu rns the DAQ to the LOCAL AREA MONITORS screen. REPORT DISPLAY If the report is directed to the screen, the first page will display immediately upon completion of the report generation. If the report is longer tha n one screen page, press the VIEW NEXT PAGE button to scroll forward through the report. Press the DISPLAY AGAIN button to restart the display at the first screen page. The PRINT DISPLAY button will send the current screen display to the print spooler. To allow multiple screen pri nts per page, the printout will not start until the END DISPLAY button is pressed to exit the report display mode. If the report is directed to the printer, the START REPORT button is displayed upon completion of the report generation. Ensure that the printer is online and that sufficient paper supply is available for the report; then press the start repo rt button. Summary Report A sample summary report is shown below. Screen an d printed summaries are identical, with the exception that the report h eader appears at on each screen page, but only appears at the top of the pri nted report. The report header contains the area information, report start date and time, and report end date and time. The first section of the report contains a summary of the time periods for which the area was in an alarm condition. The next section contains any specific comments that were ap plicable to the report period. A listing of the times that any calibratio ns of the area monitor were performed during the report period are then li sted. If any part of the report period included initialization time for the EL or PEL, general statements to that fact are included in the report. Finally, if there is an Area Comment entered, it is included at the bottom of the report.

51. 48 INITIALIZATION (.INI) FILE The CHEMDAQ.INI file in the WINDOWS directory conta ins initialization settings for various features of the DAQ system. These values are set d uring the initial installation and normally do not require adjustment. To maintain compatibility with older systems, no information is stored in the Windows registry. The following discussion des cribes the entries in the CHEMDAQ.INI file: CHEMDAQ.INI: The CHEMDAQ Data Acquisition System In itialization File TheCHEMDAQ.INI file currently contains only one sec tion describing general settings used by the DAQ system. Section Purpose [Settings] Lists settings for startup and operation of the DAQ system. This includes values used for display, alarms, and print ing. All entries listed below are required for proper op eration of the system. [Settings] Section This section contains entries for the following pro gram features: • Channel count (the number of areas that appear on t he main screen.) • User settings for the impending alarm setpoints • Type of printer attached • Backup commands • Autobackup setting • Other miscellaneous program settings The [Settings] section contains the following specific entries: MultiPortChannelCount= 4 | 6 | 8 This entry specifies the number of ports on the mul tiport board(s) in the system. The DAQ system is currently being provided with fou r or eight port boards. The value of this entry can be 4, 6, or 8. When an eig ht port board is installed, setting this value to 4 or 6 can help avoid display of exce ss unused areas on the Local Area Monitors screen. CAUTION: This section is intended for use by personnel famil iar with the Windows operating environment and the purpose and use of initializati on files. Improper changes to this file will cause the DAQ system to become inoperable .

11. 8 SECTION III STARTUP AND OPERATION OF YOUR CHEMDAQ SYSTEM TURNING ON THE SYSTEM 1. Ensure the UPS power switch is “on.” 2. Turn on the monitor by pressing the power switch to “on.” 3. Turn on the printer. 4. Turn on the system by setting the power switch t o “on.” The following should be observed as the system starts: • A whirring noise as the power supply fan turns on a nd the hard disk spins up to speed. • Various messages appear on the display as the syste m performs basic tests. • The system loads the operating system from the hard disk drive into RAM. • Messages may appear as the system loads system driv ers and necessary software. • The DAQ application launches. 5. If necessary, adjust contrast or brightness of t he screen controls on the monitor (see monitor manual). CAUTION: The DAQ monitor features a touch screen. This scre en has been factory calibrated. However, screen size and position controls are avai lable at the touch screen monitor. TO SAFEGUARD SCREEN CALIBRATION, DO NOT A DJUST THESE CONTROLS. Note: Please see Section VIII System Installation and Setup , Page 40 for instructions on installation and initial setup of the CHEMDAQ Data Acquisition System.

38. 35 SECTION V MAINTENANCE This section describes functions that require exiti ng the DAQ application. Also included is general care of DAQ hardware. SETTING THE DATE AND TIME To set the DAQ clock: • From the MAIN SETUP screen, press the DATE/TIME button. The CONTROL PANEL date and time set program will run. • In the Date/Time menu, enter the desired date and t ime. Use the TAB key to move from field to field. Press, or tab to, OK . Press ENTER . • This returns you to the MAIN SETUP screen, press the GO BACK button. CAUTION: If, at any time, you inadvertently exit the DAQ app lication, follow these steps to return to the DAQ: 1) Tap the “Start” button on the lower left of the scr een, press the keyboard button with the Windows icon, or press Ctrl-Esc. 2) Tap “Programs,” then tap “ChemDAQ Monitoring.” 3) Tap “ChemDAQ Monitoring System.” This reopens the DAQ application. Note: On Windows XP systems, a shortcut for “ChemDA Q Monitoring System” should be available directly on the “Start Menu.” DAQ alarms are inactive while the program is not ru nning. Individual Area Monitors continue to monitor their respective areas, locally alarming in the event of excessive ppm exposure.

39. 36 AUTOMATIC DATA BACKUP If enabled, the DAQ performs an automatic backup of all records at 00:01 hrs every day. Ordinarily a USB memory stick is used as the back-u p device. This function safeguards records in the event of database corruption. The back-up target device must be in the drive to e nsure proper operation of this feature. This feature is enabled or disabled via the USER SETTINGS button in the setup screen. During data backup, the Area Monitors function as n ormal. The DAQ logging, however, is suspended during the backup operation to preserve d ata integrity. Data logging resumes upon completion of the backup. The program automaticall y creates a comment for all areas noting the time of the backup. The DAQ will look for the back-up device based on t he file path recorded in the INI file. See p.#. This has been preset for you by your ChemDAQ techni cian. If the back-up device does not match the file path in the INI file, the back-up will not be successful. MANUAL DATA BACKUP To perform a manual backup (in preparation of syste m maintenance or to create a secondary backup): • Insert (or check inserted) the appropriate media into the backup drive. • From the MAIN SETUP Screen, press the icon “Backup Data Now” . • The system will perform a backup of the data files. • Store extra and secondary backup media in a cool, d ry area, away from electromagnetic interference. DATA ARCHIVING As discussed in Section II, Principals of Operation , the DAQ stores data from each Area Monitor and the calculated averages in records on t he hard drive. Over a period of time, these data files can become very large. Since the report generator must search these files to obtain data for the period being reported, the time required to generate the report increases as the files grow. Data archiving is included as a method to retain hi storical data for regulatory purposes while allowing the active data files to remain small enou gh to provide good system performance. The archived data is recorded on backup media for perma nent storage. To perform a data archive: • Acquire a USB memory stick. (ChemDAQ recommends arc hiving your data onto a memory device other than the one used for daily back-ups.} • Remove the memory stick used for back up from its U SB port. • Insert the USB memory stick that will be used for the arc hive into the USB port. It may, however, be desirable to perform a manual backup (s ee above) onto the archive media prior to continuing with the archive.

4. 1 SECTION I INTRODUCTION: THE CHEMDAQ  DATA ACQUISITION SYSTEM The CHEMDAQ Data Acquisition System (DAQ) is a PC-b ased computer software system that provides continuous collection, display, analysis, and storage of ethylene oxide (EtO) or Hydrogen Peroxide (H 2 O 2 ) exposures for up to eight Area Monitors. This in tegrated system helps to monitor immediate and long term exposure o f the monitored gas(es). The system will accept input from any combination of Steri-Trac™ or Pointgard II ™area monitors. As an area monitoring and archival system, the CHEM DAQ Data Acquisition System is not intended to meet the OSHA 29CFR1910·1047(d) require ment for initial and follow-up personnel monitoring. The Area Monitor units of the Data Acqu isition System fulfill the requirements of OSHA 29CFR1947(h)(2) for alerting employees in emer gency situations. The Data Acquisition System (DAQ) increases the eff ectiveness of individual Area Monitors by:  Centralizing all monitoring data;  Comparing all exposure levels to OSHA standards and requirements for user safety;  Alarming when these levels are exceeded or may be exceeded if current concentrations continue;  Documenting and storing all Area Monitor activity f or current review and/or later retrieval; and  Storing maintenance and calibration histories of ea ch Area Monitor unit. Specific features of the DAQ include:  Visual and audible alarms that activate when any un it exceeds its preset alarm levels;  Visual and audible alarms that warn of impending alarm levels relative to OSHA requirements;  Alarm system based on time weighted averages relati ve to OSHA requirements;  Summary and detailed reports that document calibrat ion, gas levels, alarms, and failures anywhere in the monitoring system;  Maintenance history for each Area Monitor unit to t rack sensor performance and ensure accurate monitoring; and  “User friendly” screens with touch-screen control.

41. 38 • Follow the instructions on the screen to touch a se quence of two or three dots displayed on the screen. • Select OK when prompted to verify the mouse pointer tracking . • When calibration is complete, select OK. • This returns you to the MAIN SETUP screen, press the GO BACK button. USER ADJUSTABLE IMPENDING ALARMS As stated previously, the impending alarms are inco rporated to alert the user to conditions which may result in ppm levels in excess of allowable lim its. The EL and PEL impending alarms are separate time weighted averages maintained by the s ystem. These alarms are normally set to the same concentration values as the regulatory limits, but are calculated over half the time interval (7.5 minutes for the EL and 4 hours for the PEL). The user may wish to administratively control these settings at other values. To change the valu es: • From the MAIN SETUP screen, press the USER SETTINGS button. The user settings screen will appear. • Make the desired changes to the alarm settings and the calculation intervals. • Press the GO BACK button to save the changes. GENERAL CARE OF THE DAQ SYSTEM The DAQ is engineered to provide years of reliable service. However, you should give the DAQ the same care and protection that you would any val uable equipment. Electrical Protection Sudden electrical surges can result in serious dama ge to your system. The system is provided with an uninterruptable power supply (UPS) on the s ystem unit and all peripheral equipment as shown in Figure C on page Error! Bookmark not defined. of Section VIII System Installation and Setup . It is important to include all peripheral equipment because an unprotected peripheral exposed to electrical spikes can result in damage to the entir e system. To prevent fire or shock hazard, do not expose DAQ equipment to rain, snow, or moisture.

40. 37 • From the MAIN SETUP Screen, press the ARCHIVE DATA button. • The data archive window will show the total number of months stored in the active data files. Enter the number of months to be retained in the active file or accept the default value shown. • Select START to perform the archive, or CANCEL to abort. • Option: You may decide to permanently store the arc hived DAQ data by recording it to a CD-ROM. See note below. • Remove the USB memory stick. Return the memory stic k used for backing up into the USB port. Note: You may permanently store the archived DAQ data ont o a CD-ROM using the R/W CD-ROM drive in your DAQ computer. Simply press the Windows key on your keyboard. When the Start Menu is displayed, select MY COMPUTER. In the MY COMPUTER window find the icon representing the memo ry stick containing the archived information. Press it twice to open the ic on where you will see the archived files. Go to FILE and select SELECT ALL. This will highlig ht all the files on the memory stick. Go to FILE and select SEND TO and then CD-RW Drive. Follow the prompts. When finished remember to remove the archive memory stick from the USB port and return the one used for daily back-ups. SCREEN SAVER SETUP The ChemDAQ screen saver is active only while the C hemDAQ program is running. However, for the screen saver to function properly, any stan dard Windows screen saver must be installed via the Windows Control Panel while the ChemDAQ Mon itoring System is not running. RECALIBRATING THE MONITOR TOUCH SCREEN The DAQ features touch screen control that facilita tes movement within a screen or between screens by touching the desired button, area, or fi eld. Controls are provided on the monitor for screen size and position adjustment. Normally thes e adjustments are not required. In the event of inadvertent adjustment of external controls, or in the unlikely event of screen drift, the DAQ includes a utility for recalibrating the touch scre en. To recalibrate the touch screen: • From the MAIN SETUP screen, press the CALIBRATE SCREEN button. The touch screen calibration utility will run.

36. 33 DETAIL REPORT FOR: UNIT #:01, Sterilize r Area | Key Start: 04/05/95 @ 07:01 End: 04/06/95 @ 15:00 | * - Alarm INTERVAL: 00:03 | A - Action Level CONCENTRATION (ppm) / STAT US | C - Calibrating ----------------------------- ------ | F - Unit Failure DATE-TIME CURRENT EL PEL | I - Initializing +------------------ 04/05/95 07:03 00.0 00.0 00.6 A 04/05/95 07:18 00.0 00.0 00.5 A 04/05/95 07:33 00.0 00.0 00.5 A 04/05/95 07:48 00.0 00.0 00.5 A 04/05/95 08:03 00.0 00.0 00.5 A 04/05/95 08:18 00.0 00.0 00.5 A 04/05/95 08:33 00.0 00.0 00.4 04/05/95 08:48 00.0 00.0 00.4 04/05/95 09:03 00.0 00.0 00.4 04/05/95 09:11 00.0 C 00.0 C 00.0 C 04/05/95 09:14 03.6 C 00.0 C 00.0 C 04/05/95 09:17 03.6 C 00.0 C 00.0 C 04/05/95 09:20 03.6 C 00.0 C 00.0 C 04/05/95 09:35 00.0 00.0 00.4 04/05/95 09:50 00.0 00.0 00.3 04/05/95 10:05 00.0 00.0 00.3 04/05/95 10:20 00.0 00.0 00.3 04/05/95 10:35 00.0 00.0 00.3 04/05/95 10:50 00.0 00.0 00.3 04/05/95 11:05 00.0 00.0 00.2 04/05/95 11:20 00.0 00.0 00.2 04/05/95 11:31 00.0 C 00.0 C 00.0 C 04/05/95 11:34 05.6 C 00.0 C 00.0 C 04/05/95 11:35 00.0 00.0 00.2 04/05/95 11:50 09.2 * 00.1 00.2 04/05/95 11:51 06.6 00.6 00.2 04/05/95 11:52 06.5 01.1 00.2 04/05/95 11:53 06.5 01.5 00.2 04/05/95 11:54 06.5 02.0 00.2 04/05/95 11:55 06.5 02.5 00.3 04/05/95 11:56 06.5 03.0 00.3 04/05/95 11:57 06.5 03.4 00.3 04/05/95 11:58 06.5 03.8 00.3 04/05/95 11:59 06.5 04.3 00.3 04/05/95 12:00 06.5 04.7 00.3 04/05/95 12:01 06.4 05.1 * 00.3 04/05/95 12:04 00.0 05.6 * 00.3 04/05/95 12:20 00.0 00.0 00.3 04/05/95 12:35 00.0 00.0 00.3 04/05/95 12:50 00.0 00.0 00.3 04/05/95 13:05 00.0 00.0 00.3 04/05/95 13:20 00.0 00.0 00.2 04/05/95 13:35 00.0 00.0 00.2 04/05/95 13:50 00.0 00.0 00.2 04/05/95 14:05 -- F -- F -- F __________________________________________________ _________________________ __________________________________________________ _________________________ MAXIMUM VALUES 9.2 5.6 .6 Page 1 Note: The maximum values are calculated based upon all records in the report period, not on only those displayed because of the selected report inte rval. Thus, the maximum value may be higher than all of the listed values. The black and white version of the same report is s hown below.

8. 5 The following chart summarizes operational status a nd color/alarm response: When area monitoring status is Its Area Block is GREEN LIGHT GRAY DARK GRAY BLUE YELLOW RED AUDIBLE ALARM? Normal Operation X Inactive (no monitor) X Unit is being calibrated X Action Level EXCEEDED X Y (2 beeps) PEL IMPENDING X Y (5 beeps) EL IMPENDING X Y (5 beeps) PEL EXCEEDED X Y (10 beeps) EL EXCEEDED X Y (10 beeps) Local Alarm EXCEEDED X Y (10 beeps) Unit Failure or Unit Error X Y (10 beeps) RECORDS The DAQ receives, analyzes and stores data from eac h Area Monitor unit every 20 seconds and stores this data in a record . Records contain the following information: 1) Date of record 2) Time of record 3) Current ppm at that 20 second interval 4) EL average 5) PEL average 6) Action Level status 7) PEL status 8) EL status 9) Calibration status

35. 32 DETAIL REPORT FOR: UNIT #:01, Steriliz er Area Start: 04/05/08 @ 07:01 End: 04/06/08 @ 15:00 INTERVAL: 00:03 CONCENTRATION (ppm) / STAT US ----------------------------- ------ DATE-TIME CURRENT EL PEL 04/05/95 07:03 00.0 00.0 00.6 04/05/95 07:18 00.0 00.0 00.5 04/05/95 07:33 00.0 00.0 00.5 04/05/95 07:48 00.0 00.0 00.5 04/05/95 08:03 00.0 00.0 00.5 04/05/95 08:18 00.0 00.0 00.5 04/05/95 08:33 00.0 00.0 00.4 04/05/95 08:48 00.0 00.0 00.4 04/05/95 09:03 00.0 00.0 00.4 04/05/95 09:11 00.0 Cal Cal 04/05/95 09:14 03.6 Cal Cal 04/05/95 09:17 03.6 Cal Cal 04/05/95 09:20 03.6 Cal Cal 04/05/95 09:35 00.0 00.0 00.4 04/05/95 09:50 00.0 00.0 00.3 04/05/95 10:05 00.0 00.0 00.3 04/05/95 10:20 00.0 00.0 00.3 04/05/95 10:35 00.0 00.0 00.3 04/05/95 10:50 00.0 00.0 00.3 04/05/95 11:05 00.0 00.0 00.2 04/05/95 11:20 00.0 00.0 00.2 04/05/95 11:31 00.0 Cal Cal 04/05/95 11:34 05.6 Cal Cal 04/05/95 11:35 00.0 00.0 00.2 04/05/95 11:50 09.2 00.1 00.2 04/05/95 11:51 06.6 00.6 00.2 04/05/95 11:52 06.5 01.1 00.2 04/05/95 11:53 06.5 01.5 00.2 04/05/95 11:54 06.5 02.0 00.2 04/05/95 11:55 06.5 02.5 00.3 04/05/95 11:56 06.5 03.0 00.3 04/05/95 11:57 06.5 03.4 00.3 04/05/95 11:58 06.5 03.8 00.3 04/05/95 11:59 06.5 04.3 00.3 04/05/95 12:00 06.5 04.7 00.3 04/05/95 12:01 06.4 05.1 00.3 04/05/95 12:04 00.0 05.6 00.3 04/05/95 12:20 00.0 00.0 00.3 04/05/95 12:35 00.0 00.0 00.3 04/05/95 12:50 00.0 00.0 00.3 04/05/95 13:05 00.0 00.0 00.3 04/05/95 13:20 00.0 00.0 00.2 04/05/95 13:35 00.0 00.0 00.2 04/05/95 13:50 00.0 00.0 00.2 04/05/95 14:05 Fail Fail Fail __________________________________________________ _________________________ __________________________________________________ _________________________ MAXIMUM VALUES 9.2 5.6 . 6 Page 1 A sample color detailed report is shown below.

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