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Appendix C. Statements of Compliance

112

1006232_RevD



Progeny instruments meet wavenumber tolerances established by RAD with input from 3rd
party consultants.



Progeny instruments can be installed and qualified using an IQOQPQ procedure to ensure that
performance criteria meet wavenumber tolerances specified by RAD.



Verification of the intensity scale is unnecessary since quantitative analytical methods are not
intended to be transferred between instruments.



Progeny instruments use both commercially available and user created libraries for
identification of materials.

Содержание Progeny

Страница 1: ...1006232_RevD 3 Progeny and Progeny LT Analyzer User Manual Rev D...

Страница 2: ...ation but Rigaku Analytical Devices Inc assumes no responsibility or liability for any errors or inaccuracies that may appear in this documentation DOCUMENTATION IS PROVIDED AS IS AND ALL EXPRESS OR I...

Страница 3: ...roscopy 10 What You Can Do with Progeny Analyzers 10 Verify Chemicals 11 Setup Flexible Laboratories 11 Screen for Counterfeit Products 11 Ensure Homeland Security 11 Identify Narcotics 11 Getting Sta...

Страница 4: ...Setting Scan Conditions 28 Optimize focus of the instrument basic mode 28 Optimize Focal Length advanced mode 28 Preparing to Scan Other scan settings and properties 29 Performing Scans 30 Scanning w...

Страница 5: ...Setting 73 Customizing Data Options 73 Choosing Language 74 Search Again 74 Results 74 Managing User Accounts 75 Adding User Accounts 75 Viewing User Accounts 77 Changing User Permission Levels 78 Loc...

Страница 6: ...ations 102 Physical Specifications 102 Electronics and Data Processing Specifications 102 Environmental Specifications 103 Electrical Specifications 103 Appendix B Nose Cone Positions 104 Appendix C S...

Страница 7: ...Contents v 1006232_RevD European WEEE Recycling and RoHS 114 WEEE Compliance 114 WEEE Konformit t 114 Conformit DEEE 114...

Страница 8: ...results output templates Configuring Progeny Analyzers Administrator Setting up the instrument Customizing the instrument Managing user accounts Barcode Scanner All uses Using the barcode Batch Colle...

Страница 9: ...oss of data and invalid test results or is necessary for optimal performance of the system If listed procedures are not followed data integrity may be affected Note Notes highlight tips for performing...

Страница 10: ...Standard for Laser Products contained in the regulations of 21 CFR Sub Chapter J except for deviations pursuant to Department of Health and Human Services issued Laser Notices The Progeny Analyzer com...

Страница 11: ...ardous environments it is not inherently safe in any environment Follow the general safety precautions and special safety instructions in this manual to guarantee the best possible operating safety If...

Страница 12: ...ult in harm to the operator or damage to your instrument Progeny contains a lithium ion battery which has been designed to be safe under normal operating conditions Due to the nature of Li ion batteri...

Страница 13: ...tic liquids including but not limited to Chlorine gas Hydrochloric acid Ammonia Concentrated hydrogen peroxide Sulfuric acid Aqueous sodium hydroxide Please contact RAD if you require modifications fo...

Страница 14: ...round the globe Progeny Analyzers provide the power of Raman spectroscopy with no compromises Actionable software provides either simple PASS FAIL decisions or more detailed analyses for a variety of...

Страница 15: ...Introduction 8 1006232_RevD Figure 1 Top View Display Keypad Battery door Active laser warning Heat sink Power Enter...

Страница 16: ...the carrying case and including the following items Charger Cables Battery Instrument Any RAD instrument accessories Close both latches to secure the case before lifting it Important When packed with...

Страница 17: ...ng some of its ground state energy to the emitted light Raman shifts are called inelastic scattering because of this energy transfer between molecules and photons during their interaction This energy...

Страница 18: ...ion and Development OECD puts the value of counterfeit consumer goods chemicals pesticides food beverage products precious gems and pharmaceuticals crossing international borders at more than 250 bill...

Страница 19: ...ith the top up and battery door facing you 2 Place your thumbs under each side of the door latch 3 Pull the door latch out and up until it snaps open Figure 4 4 Disengage the clip at the top of your i...

Страница 20: ...o place Charging the Battery After installing the battery if Power Status Figure 5 indicates that power is low charge the battery 1 Insert the AC adapter power cord into the connector behind the batte...

Страница 21: ...out your startup requirements please talk with your organization s primary systems administrator Typically you see one of the following If no login is required the Main screen displays and the instrum...

Страница 22: ...Main Screen with No Login Figure 7 Select User Screen When login is configured with the User List option disabled the Enter User Name screen displays a virtual keyboard for entering your user name an...

Страница 23: ...e Touchscreen The touchscreen provides access to features applications and depending on permission level instrument configuration settings The following gestures are available Gesture Use to Touch Sel...

Страница 24: ...ne screen to other related screens Select letters and numbers from the virtual keyboard to enter information Note You can only highlight one control menu item or letter at a time Once the required con...

Страница 25: ...ow hard keys to move to a required letter 4 Press the Power Enter hard key to select the highlighted letter 5 When all the required letters appear in the textbox press Arrow hard keys to move to the E...

Страница 26: ...ormation about the possible types of passwords see Using Standard or Strong Passwords Note The characters in the password appear as an asterisk in the password box 5 Select Enter If the password is co...

Страница 27: ...creen 4 Repeat the login process If your password no longer works contact your organizations primary systems administrator for instructions Resetting User Passwords Your Administrator can reset a forg...

Страница 28: ...below Feature Enables you to Scan Identify unknown substances from collections of known substances libraries Verify known substances Pass Fail Add spectral profiles to Master Library or into Custom Li...

Страница 29: ...Instrument Calibration Extended screen Indicates that you can view hidden sections of the current screen The number of icon items shows the number of available sections The visible section is gray Hid...

Страница 30: ...ng operations developing applications or configuring your instrument log out of your user account 1 Select Cancel Back until the Main screen displays 2 Select your user name to display the Logout conf...

Страница 31: ...y issues with spectra the instrument has been recently serviced or if the instrument has been stored The Progeny Analyzer checks for the latest calibration status to ensure that it accurately processe...

Страница 32: ...applications 1 From the Main screen select Calibration from the left of the action bar to display the Select Method screen with the calibration options Figure 11 Figure 11 Select Method Screen for Cal...

Страница 33: ...strument Calibration unless you run Performance Verification and get a failing result or the instrument was recently serviced and or spectral performance has changed or if there is a RED checkmark in...

Страница 34: ...e holder and repeat the above Calibration steps Contact your organization s primary system administrator RAD or your local RAD representative Preparing to Scan Hazardous or Volatile Materials In a pot...

Страница 35: ...on into the sample A chart is included in Appendix B with recommended settings based on the type of packaging Alternatively the user can determine the optimal focus based on a possible range of distan...

Страница 36: ...d be used for any further testing Preparing to Scan Other scan settings and properties Once the focal point is set for a sample there are other scan properties that may need to be adjusted to get suff...

Страница 37: ...returned on the instrument The user can set the output of the instrument to be either Identification mode which returns the closest match from the library to the sample or to Verification mode which r...

Страница 38: ...Scan options select Analyze to display the Analyze confirmation screen with the laser warning Figure 15 Figure 15 Laser Warning 3 Select OK ARM LASER to display the Analyze scan screen with the sampl...

Страница 39: ...key to review information about and or change current scan properties A screen listing your instrument s current scan configuration displays the property settings for the Collect Settings category Fig...

Страница 40: ...on Returns to the previous screen Optimize Opens Optimize panel Default setting Return all settings to the factory default setting Auto Collect Baseline Correction Wavelet algorithm Search Master Libr...

Страница 41: ...g the spectral response of the sample Note When Auto Exposure is enabled ON Exposure and Averages settings are disabled Exposure Soft Key 1 000 ms default Range 5 ms min 30 000 ms max Opens a settings...

Страница 42: ...thm Type Soft Key Wavelet default HQI optional Rigaku Mixture optional Associates current Analyze scan or application with a specific algorithm type Opens a settings screen through which you can scrol...

Страница 43: ...abled when Search Algorithm type is set to HQI Wavelength End Soft Key 2 500 cm 1 default Range 2 500 cm 1 max 200 cm 1 min Opens a settings screen through which you can scroll to select the value Set...

Страница 44: ...the spectral data Searching onboard libraries for spectral matches Important Do not move the instrument during the Background and Scanning phases of the sample analysis cycle Moving the instrument dur...

Страница 45: ...he scan results record 6 If required attach an Image to the result a Press the Camera hard key to display the Capture Image screen appears with a viewfinder b Point the Progeny unit at the object to b...

Страница 46: ...return to the Main screen The following options are available Control Name Type Description Cancel back Cancels current action Returns to the previous screen Camera Record barcodes and screen capture...

Страница 47: ...have two types of applications Verification and Identification Verification applications check that your substances are what you expect them to be by comparing scan results to a specified spectral pr...

Страница 48: ...the user Verification of Known Substances Verification applications confirm that a sample is the expected substance The custom application uses the pre defined instrumental settings and prompts the us...

Страница 49: ...erification or Sample Verification to highlight it 4 Select Enter to launch the application 5 The Select Material screen displays listing all the spectral profiles available in the spectral sub librar...

Страница 50: ...ars Figure 21 Figure 21 Verification Application Scan Screen 9 Select the Scan soft key to start the sample analysis cycle When the sample analysis cycle is completed the scan results screen displays...

Страница 51: ...ith a viewfinder b Point the Progeny unit at the object to be captured e g material container label etc c Press the Camera hard key again or the Camera Icon d Select Enter to acknowledge the Save Imag...

Страница 52: ...ded in the linked spectral sub library and calculates the correlation of the sample to the library material Profile data from up to five matches are listed sequentially with the closest match as Top M...

Страница 53: ...hows the laser warning Figure 20 5 Select OK ARM LASER to display the application s scan screen Figure 24 Figure 24 Identification Application Scan Screen 6 Select the Scan soft key to start the sampl...

Страница 54: ...Image screen with a viewfinder b Point the Progeny unit at the object to be captured e g material container label etc c Press the Camera hard key again or the Camera Icon d Select Enter to acknowledg...

Страница 55: ...ith the selected results report template c Review the report and if required sign or print the report d Drag Extended screen to the right or select it and press the left arrow hard key to return to th...

Страница 56: ...creen 3 The Results screen displays with the tab for the current week selected and lists the scan results summaries by date Figure 27a Figure 27a Results Screen 4 Scroll through the screen to view sum...

Страница 57: ...rom that week within the current month 6 To review summaries from a different month a Select Month to display the Select Month screen listing previous months that may contain scan results records b Sc...

Страница 58: ...l instrument hardware and software features 1 From the Main screen select Settings to display the Instrument Settings screen 2 From the list of Instrument Settings categories select Information to dis...

Страница 59: ...dation requirements Progeny Analyzers automatically save instrument status and activity data for all users To view logged data select Audit Log a The icons near the top of the screen show audit log da...

Страница 60: ...escriptions Temperature Optical Engine 30 40C but can vary by environment Optical engine internal temperature Detector 5C but varies by environment Detector package temperature Power Battery Varies Di...

Страница 61: ...een listing both the Master Library and any defined sub libraries a Select the Master Library or any defined sub libraries to view the library profile names b Select the profile names to view the prof...

Страница 62: ...search the library Figure 31 Search Results 5 Select the spectral file from the resulting list to display the detailed spectral profile screen Figure 32 6 Scroll through the list to see all details En...

Страница 63: ...r the spectral library match Sub Libraries Name s of sub libraries this material appears in Manufacturer Name s of the manufacturer s for the spectral library match Appearance Substance description fo...

Страница 64: ...of good quality the results for any profiled compared to them could be compromised When adding spectral profiles of new substances to the Master Library you may need to run a series of tests to optim...

Страница 65: ...or select it and press the left arrow hard key to review and or change current scan properties A screen listing your instrument s current scan configuration displays the property settings for the Col...

Страница 66: ...creen 8 Use the virtual keyboard or the touchscreen to enter the name of the sample substance Select Enter to open the Select Library list Choose a library to add the new substance to The new profile...

Страница 67: ...the different sub libraries in specific situations or link them to specific scanning applications With this flexibility you can maintain a general purpose profile in the Master Library and target sub...

Страница 68: ...libraries have no linked spectral profiles Until you add copies of Master Library profiles applications that use the sub libraries have no access to spectral profiles for verifying or identifying sam...

Страница 69: ...profile once to highlight it then again to select it A checkmark displays to the right side of the spectral profile name Figure 36 Figure 36 Add Spectra Screen with Marked Profile Note To deselect a p...

Страница 70: ...to the Instrument Settings screen Removing Spectral Profiles from Sub Libraries If you no longer run applications that verify or identify samples of specific substances included in a spectral sub lib...

Страница 71: ...u can delete the sub library However if you remove a sub library that is still being used by an application the application may not function correctly Important Before deleting a sub library make sure...

Страница 72: ...plications List 1 From the Main screen select Settings 2 From the list of Instrument Settings select Applications to display the Applications screen listing all of the instrument s current application...

Страница 73: ...onal applications 6 Select Back to return to the Instrument Settings screen Configuring Applications After adding the required new applications to your Progeny Analyzer you must configure them to opti...

Страница 74: ...Advanced Options 67 1006232_RevD Figure 40 Sample Application...

Страница 75: ...one disabled 5 max Opens a setting screen through which you can scroll to select the value When set to None or disabled no library matches are displayed Use this setting for Verification applications...

Страница 76: ...ou must enable user login before configuring the instrument 1 Select Settings from the Main screen to display the Instrument Settings screen 2 Enable Login Required 3 Log out and restart your instrume...

Страница 77: ...ermission Levels Administrator Developer Operator Global Settings Library Applications Report Templates Users E Signatures Batch Collection Date and Time Communication Information Diagnostics Green Av...

Страница 78: ...gin Method Customizing Data Options and Choosing Language for details 4 Select Enter to display the Instrument Settings screen Configuring Login 1 Select Login from the Global Settings screen 2 Select...

Страница 79: ...the specified number of days Default setting is 90 days Click to launch the settings screen Available settings are intervals of 30 days from 30 to 360 Note When the lower end of the setting range is d...

Страница 80: ...performed on the Progeny LDAP User ldapadmin Password 144 This special Admin user can only be used after Progeny restart If the user has logged out the Progeny must be restarted in order for this user...

Страница 81: ...Enter to set the new Data Options and return to the Instrument Settings screen Choosing Language 1 Select Language from the Global Settings screen 2 Select the Language key to display a list of availa...

Страница 82: ...nts and three user permission levels as follow User level Allows users to Administrator Access all instrument settings Configure instrument features and data output Set up network connections Manage a...

Страница 83: ...ssion Level Screen 3 Select the required permission level for the User then Enter to display the Enter User Name screen Figure 44 Note Until a valid user name is selected Invalid appears in place of E...

Страница 84: ...t Enter to display the Permission Level User name and a temporary password Figure 45 Note If the user name you enter is the same as a current or locked user name the instrument will show you a warning...

Страница 85: ...account restricts that users access to the Progeny Analyzer This ensures that only users with current authorization can access the instrument It can also be used to retire specific user accounts When...

Страница 86: ...the Users screen select a locked user account from the accounts list to display the Unlock user confirmation screen 2 Select Enter to display the User Unlocked screen with a new temporary password lis...

Страница 87: ...correctly before using them the barcode scanner can be used in lieu of manually entering the compound name or selecting the compound from a list By eliminating this step the material verification pro...

Страница 88: ...d using either the barcode soft key or the camera hard key 1 Point the front of Progeny at the object to be scanned 2 Touch Barcode on the screen or press and hold the Camera hard key on the keypad to...

Страница 89: ...urements Per Sample Number of times to scan each sample from each container in the batch session In addition to the default session parameter prompts your organization may need to collect other batch...

Страница 90: ...Customizing User Prompts Although the basic parameters that specify the extent of batch collection sessions are required the prompts may be customized for your organization including any prompts for...

Страница 91: ...to launch the application and display the Select Material screen listing the spectral profiles available in the spectral sub library linked to the application Figure 52 5 Scroll through the list and s...

Страница 92: ...53 Batch ID Prompt 7 Input the batch ID and select Enter to display the Number of Containers prompt Figure 54 shows the number of containers set to 1 234 Note A total of 9 999 containers are possible...

Страница 93: ...ter 12 Select OK ARM LASER to display the application s scan screen for the selected substance 13 Select Scan Figure 55 Figure 55 Batch Mode Scan Screen The user will be led step by step through the e...

Страница 94: ...firmation Screen 2 Press Enter to cancel the Batch and display a new screen 3 Enter the Batch Cancel Memo Figure 57 Figure 57 Batch Cancel Memo The Batch Summary screen displays with relevant Batch in...

Страница 95: ...tch Collection 88 1006232_RevD Figure 58 Batch Summary To resume the Batch Collection a Select Batch Resume Or b Navigate to Results to see the incomplete Batch indicated with a yellow maker Figure 59...

Страница 96: ...d select Enter Note Using either option returns user to Scan Mode 1 Continue Batch collection 2 Upon completion if desired add a Batch Complete Memo Figure 59b Fixure 59b Batch Complete Memo 3 When do...

Страница 97: ...ows 10 USB port or Wi Fi connection Compatible Web Browsers Explorer Chrome Firefox Note A broadband connection is not necessary for connection Progeny to PC Configuration via USB connection 1 Connect...

Страница 98: ...ogeny Web Browser Screen 4 Click on a date from the calendar view or an individual Results filename to open it as a PDF form in a new browser window 5 To download individual or multiple files select I...

Страница 99: ...back to the library Figure 63 Chemical Spectra in Library Progeny to PC Configuration via Simple Wi Fi connection There are two types of Wi Fi connection methods simple and advanced To connect your P...

Страница 100: ...e 64 Wireless Network Connection List 5 Select a wireless network with a green key icon from the Wireless Connections list by tapping on that row in this case RAC WIL GUEST then tap the Connect key Fi...

Страница 101: ...http 10 9 4 108 To display the Progeny Instrument details Note Do not include WWW prefix Progeny to PC Configuration via Advanced Wi Fi connection 1 To connect your Progeny Analyzer to the PC using a...

Страница 102: ...e WiFi Connection using the Browse or Choose File button Figure 67 Figure 67 Configuring Wi Fi Network Connection 3 After selecting the file and clicking the Submit key a message is displayed indicati...

Страница 103: ...Enter to return the Settings screen 7 Navigate to the Communications settings to view the list of detected available wireless networks Figure 68 Figure 68 Wireless Network Connection List 8 Select a w...

Страница 104: ...Recent results are on the Progeny and have not been downloaded or copied to an external PC Archived results are results that have been previously downloaded and copied to an external PC Audit Log cont...

Страница 105: ...import a Include Users Imports all user information from another device b Include Global Settings Imports all Global instrument settings from another device c Include Applications Imports all Applica...

Страница 106: ...Export and Import Settings 99 1006232_RevD Figure 70 Progeny Settings Screen...

Страница 107: ...itary wipes clean all loose or stuck on materials off the surfaces of your instrument from front to back in the following sequence Laser aperture Front Top Sides Bottom Back 3 When finished let your i...

Страница 108: ...eny Analyzer helps ensure that cross substance scanning issues do not occur After scanning open air samples or after the lens aperture becomes soiled clean your instrument with pre packaged sanitary w...

Страница 109: ...ion spectral 8 11 cm 1 FWHM across range Detector 512 pixel TE Cooled InGaAs Dispersion mode Transmissive VPG Collection optics NA 0 25 Sampling Specifications Specification Value Sample distance with...

Страница 110: ...ticals household chemicals and other toxic substances For more information contact RAD or your local Rigaku representative Software RAD Progeny Software For upgrades contact RAD or your local Rigaku r...

Страница 111: ...Appendix B Nose Cone Positions 104 1006232_RevD Appendix B Nose Cone Positions...

Страница 112: ...and experience to perform their assigned tasks Technical and system controls that provide computer generated time stamped audit trails for system activities electronic records and electronic signature...

Страница 113: ...rument and scan records cannot be altered on the instrument In addition the instrument cannot permanently store electronic records Once scanning is complete electronic records must be delivered to a s...

Страница 114: ...erform the operation at hand Progeny 1064 By default the instrument has three levels of user permissions Administrator Developer and Operator System administrators must specify one of these user permi...

Страница 115: ...ed with the signature Progeny 1064 When confirming records the instrument creates an electronic record of each confirmation that includes information about when the signature was applied to the record...

Страница 116: ...instrument uses both a user name and a password to identify each user at instrument login Requirement 11 200 a 1 i When an individual executes a series of signings during a single continuous period of...

Страница 117: ...ion of identification code and password b Ensuring that identification and password issuances are periodically checked recalled or revised c Following loss management procedures to electronically deau...

Страница 118: ...have a calibration validation routine based on a certified benzonitrile cyclohexane or naphthalene calibration standard that can be used to verify instruments calibration Progeny instruments have appr...

Страница 119: ...installed and qualified using an IQOQPQ procedure to ensure that performance criteria meet wavenumber tolerances specified by RAD Verification of the intensity scale is unnecessary since quantitative...

Страница 120: ...rument is not intended to be used in a hazardous location The battery pack should be charged only with a suitably certified or approved battery charger This Class A digital apparatus meets all require...

Страница 121: ...State and these companies should dispose of or recycle this product For further information contact RAD or your local RAD representative WEEE Konformit t Dieses Prudukt muss die EU Waste Electrical El...

Страница 122: ...s est associ avec une ou plusieurs compagnies de recyclage dans chaque tat membre de l union europ enne et ce produit devrait tre collect ou recycl par celles ci Pour de plus amples renseignements ve...

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