ThermoFisher Scientific Applied Biosystems RapidHIT ID System v1.3.1 User Manual
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ThermoFisher Scientific Applied Biosystems RapidHIT ID System v1.3.1 User Manual

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™
RapidHIT
USER GUIDE
for use with:
RapidLINK
™
Software v1.1.5
Publication Number MAN0018938
Revision A.0
For Forensic, Human Identification, or Paternity/Kinship Use Only. Not
for use in diagnostic or therapeutic applications.
ID System v1.3.1

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  • Page 1 ™ RapidHIT ID System v1.3.1 USER GUIDE for use with: RapidLINK ™ Software v1.1.5 Publication Number MAN0018938 Revision A.0 For Forensic, Human Identification, or Paternity/Kinship Use Only. Not for use in diagnostic or therapeutic applications.
  • Page 2 Life Technologies Corporation | 6055 Sunol Blvd | Pleasanton, CA 94566 USA For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition. The information in this guide is subject to change without notice. DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

  • Page 3: Table Of Contents

    Contents ■ CHAPTER 1 Product information ..........7 Product description .
  • Page 4 Contents ■ CHAPTER 4 Manage the instrument and software ......28 View and export the run results for all runs (administrator or supervisor only) ..28 Configure instrument settings (administrator or supervisor only) .
  • Page 5 Contents ■ APPENDIX D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) ........... . 62 Background .
  • Page 6 Contents ■ Documentation and support ............89 Related documentation .

  • Page 7: Chapter 1 Product Information

    Product information ■ Product description ..............7 ■...

  • Page 8: Sample Cartridge Types

    Chapter 1 Product information Sample cartridge types Sample cartridge types Abbreviation on labels / in Sample type STR chemistry Features For more information see software ™ ™ RapidHIT ID ACE GlobalFiler Express Sample Cartridge ™ ACE GFE / GFE Single-source, GlobalFiler Optimized data Appendix E, “Software verification...

  • Page 9: Parts Of The Instrument

    Chapter 1 Product information Parts of the instrument Parts of the instrument Camera Power button (controls the internal computer) Sample cartridge port USB port Touchscreen (display screen) Rear panel with main power switch, USB, and computer connections Fingerprint reader Primary cartridge (contains gel cartridge) The instrument also includes an internal environmental sensor that monitors temperature and humidity.

  • Page 10: Required Materials Not Supplied

    Chapter 1 Product information Required materials not supplied Required materials not supplied Unless otherwise indicated, all materials are available through thermofisher.com. "MLS" indicates that the material is available from fisherscientific.com or another major laboratory supplier. ™ ™ Table 1 RapidHIT ID Primary Cartridge GlobalFiler Express 100 Kit (Cat.

  • Page 11: Network And Password Security Requirements

    Chapter 1 Product information Network and password security requirements Table 3 Sample cartridges Component Cat. No. RapidHIT ™ ID ACE GlobalFiler ™ Express 50 Sample Kit A41831 50 sample cartridges, 2 positive control cartridges, 2 negative control cartridges ™ ™ RapidHIT ID ACE NGM SElect Express 50 Sample Kit...

  • Page 12: Workflow

    Chapter 1 Product information Workflow Workflow Obtain swab or substrate samples according to your standard operating procedure. ▼ Sign in. ▼ Scan the sample cartridge barcode or enter the sample identification number. IMPORTANT! Do not include the following in sample IDs: "ladder", "posctrl", or "negctrl" (case does not matter).
  • Page 13 Chapter 1 Product information Workflow The countdown timer starts at 110 minutes. The typical run time is ~90 minutes. Note: The timer stops when the run is complete. The timer does not decrease to 0 minutes. For more information, see “Run times for different sample cartridges”...

  • Page 14: Chapter 2 Collect And Prepare The Sample

    Collect and prepare the sample ■ ™ ™ Sample collection: GlobalFiler Express and NGM SElect Express sample cartridges ..14 ■ ™ Sample collection: RapidINTEL sample cartridges ........14 ™...

  • Page 15: Chapter 3 Run The Instrument To Generate A Dna Profile

    Run the instrument to generate a DNA profile ■ Power on the internal computer ............16 ■...

  • Page 16: Power On The Internal Computer

    Chapter 3 Run the instrument to generate a DNA profile Power on the internal computer Power on the internal computer IMPORTANT! Leave the main power switch (on the back panel) set to On at all times. Power is necessary to maintain the gel temperature. Press the power button on the front lower-right of the instrument.

  • Page 17: Sign In To The Instrument

    Chapter 3 Run the instrument to generate a DNA profile Sign in to the instrument Sign in to the instrument You can sign in using any of the authentication methods that are configured for your profile. • To use facial recognition or fingerprint methods, position your face in front of the camera or touch the fingerprint reader.
  • Page 18 Chapter 3 Run the instrument to generate a DNA profile Sign in to the instrument • To use a PIN, perform the following steps. a. Touch the lock screen. b. Touch c. Touch , then select your user name. d. Enter your PIN with the keypad. The sample identification screen is displayed.

  • Page 19: Parts Of The Sample Identification Screen

    Chapter 3 Run the instrument to generate a DNA profile Parts of the sample identification screen Parts of the sample identification screen ™ No icon is displayed if the instrument is connected to the RapidLINK Software. Indicates that the instrument is not connected to the RapidLINK ™...

  • Page 20: Enter A Sample Id Or Barcode

    Chapter 3 Run the instrument to generate a DNA profile Enter the sample identification number Enter a sample ID or barcode 1. If the sample identification screen is not displayed, touch until it is displayed. 2. Touch the sample identification screen. 3.

  • Page 21: Insert The Sample Cartridge Into The Instrument (Automatically Starts The Run)

    Chapter 3 Run the instrument to generate a DNA profile Insert the sample cartridge into the instrument (automatically starts the run) Insert the sample cartridge into the instrument (automatically starts the run) A sample cartridge run takes ~90–110 minutes to complete. 1.

  • Page 22: Run Times For Different Sample Cartridges

    Chapter 3 Run the instrument to generate a DNA profile Run times for different sample cartridges 2. When the insert sample cartridge screen is displayed, insert the sample cartridge (containing the sample swab) into the sample cartridge port. See the following figures. The run starts automatically after you insert the sample cartridge.

  • Page 23: Remove The Sample Cartridge From The Instrument

    Chapter 3 Run the instrument to generate a DNA profile Remove the sample cartridge from the instrument Remove the sample cartridge from the instrument 1. If the lock screen is displayed, touch the lock screen, then sign in. 2. When the remove sample cartridge screen is displayed, remove the sample cartridge from the instrument.

  • Page 24: Check The Run Result

    Chapter 3 Run the instrument to generate a DNA profile Check the run result 3. Tap Done to dismiss the result screen. 4. Discard the sample cartridge. Use proper precautions for disposal. Follow local, state, provincial and federal regulations for disposal.

  • Page 25: View And Export The Run Results

    Chapter 3 Run the instrument to generate a DNA profile View and export the run results 1. Review the status. DNA profile Status Meaning Action is generated Green The DNA profile does not The DNA profile is ready for analysis by the contain quality score flags.

  • Page 26: Sign Out

    Chapter 3 Run the instrument to generate a DNA profile Sign out 3. (Optional) To export, insert a USB device into the front USB port on the instrument. Touch Export. Note: The Export button is not displayed if: ™ · The RapidHIT ID Instrument is configured to delete the run data after it is transferred to the ™...
  • Page 27 Chapter 3 Run the instrument to generate a DNA profile Sign out The lock screen is displayed. RapidHIT ™ ID System v1.3.1 User Guide...

  • Page 28: View And Export The Run Results For All Runs (Administrator Or Supervisor Only)

    Manage the instrument and software ■ View and export the run results for all runs (administrator or supervisor only) ....28 ■ Configure instrument settings (administrator or supervisor only) ......29 ■...

  • Page 29: Chapter 4 Manage The Instrument And Software

    Chapter 4 Manage the instrument and software Configure instrument settings (administrator or supervisor only) 4. (Optional) To export, insert a USB device into the front USB port on the instrument. Touch Export. Note: The Export button is not displayed if: ™...
  • Page 30 Chapter 4 Manage the instrument and software Configure instrument settings (administrator or supervisor only) 4. In the settings screen, configure the instrument settings as needed. Setting Description User access Start Backup and See “Back up and restore data (administrator only)” on page Administrator Start Restore...

  • Page 31: Manage Users (Administrator Only)

    Chapter 4 Manage the instrument and software Manage users (administrator only) Manage users (administrator only) User roles and permissions User role Permission to perform the following tasks • Perform a run Operator • View the run log for the signed-in user Supervisor Operator tasks, plus: •...
  • Page 32 Chapter 4 Manage the instrument and software Manage users (administrator only) 4. Touch (Add user). Select a user role Enter a user name Touch Enter 5. To assign a role to the user, touch Supervisor, Admin, or Operator. For a description of user roles, see “User roles and permissions” on page 6.
  • Page 33 Chapter 4 Manage the instrument and software Manage users (administrator only) Option Procedure Face Recognition 1. Adjust the user position so that the face is centered in the live camera view. 2. Touch Start Face Scan. Fingerprint Scan 1. Place any of the user's fingers on the fingerprint pad on the front of the instrument.

  • Page 34: Remove Authorization For An Instrument

    Chapter 4 Manage the instrument and software Manage users (administrator only) 10. Touch the success message screen to close it, then touch Done to close the add user screen. Touch Done Remove authorization for an instrument When you remove authorization, you prevent the user from signing in to an instrument. ™...

  • Page 35: Routine Maintenance

    Maintain the instrument ■ Routine maintenance ..............35 ■...

  • Page 36: Chapter 5 Maintain The Instrument

    Chapter 5 Maintain the instrument View primary cartridge information View primary cartridge information If the sample identification screen is not displayed, touch until it is displayed. The screen displays the gel volume, expiration date, and number of runs performed for the primary cartridge. Gel volume—Indicates the amount of gel remaining in the primary cartridge.

  • Page 37: Replace The Primary Cartridge (Administrator Or Supervisor Only)

    Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) Replace the primary cartridge (administrator or supervisor only) This procedure requires ~2 hours to complete. ™ Note: For RapidINTEL Sample Cartridge applications, use a GFE primary cartridge. Parts of the primary cartridge The following figures illustrate the parts of the primary cartridge.

  • Page 38: Prepare A New Primary Cartridge

    Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) Prepare a new primary cartridge You need the following components for this procedure: • New primary cartridge • Gel cartridge that is provided with the new primary cartridge •...
  • Page 39 Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) Note: You can touch the numbered buttons to display illustrations for the following steps. 5. Unscrew the shipping plug in the cathode block. RapidHIT ™ ID System v1.3.1 User Guide...
  • Page 40 Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) 6. Turn the shipping plug in the check valve 90° counterclockwise, then remove it. 7. Gel cartridge: Remove the shipping plug from the gel cartridge inlet by pulling the plug straight out of the inlet.
  • Page 41 Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) The gel cartridge clicks when it is fully inserted into the primary cartridge. 9. Remove the shipping cover from the capillary by pressing the brackets toward the cover, then swinging the cover up and away from the capillary.

  • Page 42: Insert The Prepared Primary Cartridge (Administrator Or Supervisor Only)

    Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) 10. Touch Done at the bottom of the primary cartridge screen. 11. When the insert utility cartridge screen is displayed, insert the utility cartridge into the instrument. The utility cartridge has a red label and is provided with the new primary cartridge.
  • Page 43 Chapter 5 Maintain the instrument Replace the primary cartridge (administrator or supervisor only) 1. When the remove primary cartridge screen is displayed (~3 minutes after you insert the utility cartridge in the instrument in step 11 in the previous procedure), pull the used primary cartridge out of the instrument.

  • Page 44: Run A Control Cartridge

    Chapter 5 Maintain the instrument Run a control cartridge Run a control cartridge ™ Note: For RapidINTEL Sample Cartridge applications, use a GFE control (allelic ladder) cartridge. 1. If the sample identification screen is not displayed, touch until it is displayed. 2.

  • Page 45: Back Up And Restore Data (Administrator Only)

    Chapter 5 Maintain the instrument Back up and restore data (administrator only) Back up and restore data (administrator only) The backup function copies run data from the instrument to a USB device. It does not copy user profiles or instrument settings.

  • Page 46: Appendix A Troubleshooting

    Troubleshooting ■ ™ Check the RapidLINK Software connection ..........46 ■...
  • Page 47 Appendix A Troubleshooting Troubleshooting: Symptoms, causes, and actions Observation Possible cause Recommended action An error code is displayed when you sign in There is a problem with the Record the error code. instrument. Contact Thermo Fisher Scientific Support. ™ Indicates that the See “Check the RapidLINK is displayed on the sample identification screen instrument is not connected to...
  • Page 48 Appendix A Troubleshooting Troubleshooting: Symptoms, causes, and actions Observation Possible cause Recommended action RapidINTEL ™ run is listed as a GFE run in ™ A RapidINTEL cartridge run No action. ™ RapidLINK Software failed on the instrument and the correct cartridge information is not sent to the ™...

  • Page 49: Appendix B Instrument Specifications

    Instrument specifications ■ Dimensions, clearance, and weight ........... . . 49 ■...

  • Page 50: Instrument Layout And Connections

    Appendix B Instrument specifications Instrument layout and connections Instrument layout and connections Figure 4 Dimensions and clearances Height 48 cm (19 in.) Height clearance 25 cm (10 in.) Length (depth) 53 cm (21 in.) Length (depth) clearance 28 cm (11 in.) Length (depth) clearance when replacing the primary cartridge114 cm (45 in.) Width 27 cm (10.5 in.) Width clearance 13 cm (5 in.)
  • Page 51 Appendix B Instrument specifications Instrument layout and connections Figure 5 Rear panel Main power switch Power connection USB port for optional barcode scanner connection Ethernet port for computer connection Figure 6 Component connections Instrument Optional barcode scanner Computer Total length (depth) space required 109 cm (43 in.) Total width space required 116 cm (45 in.) RapidHIT ™...

  • Page 52: Environmental Requirements

    Appendix B Instrument specifications Environmental requirements Environmental requirements Condition Requirement Installation site Indoor use only Altitude Safety tested up to 2,600 meters (8,500 feet) Electromagnetic interference Do not use this instrument near sources of strong electromagnetic radiation (for example, unshielded intentional RF sources). Strong electromagnetic radiation can interfere with the proper operation of the device.

  • Page 53: Electrical Requirements

    Appendix B Instrument specifications Electrical requirements Electrical requirements CAUTION! Do not unpack or plug in any components until they are configured for the proper operating voltage by the service representative. WARNING! For safety, the power outlet for the instrument must be accessible at all times. In case of emergency, you must be able to immediately disconnect the main power supply to all the equipment.

  • Page 54: Appendix C Analysis Settings

    Analysis settings ■ Threshold settings ..............54 ■...
  • Page 55 Appendix C Analysis settings Threshold settings Table 6 Threshold settings (contained in panel) (continued) ™ ™ RapidHIT ID ACE RapidHIT ID ACE NGM ™ RapidINTEL Sample ™ ™ System Threshold GlobalFiler Express SElect Express Sample Cartridge Sample Cartridge Cartridge Locus-specific filter 30% for the positive control Ploidy (PL flag) threshold...

  • Page 56: Display Analysis Settings In The Genemarker ™ Hid Str Human Identity Software

    Appendix C Analysis settings Display analysis settings in the GeneMarker ™ HID STR Human Identity Software Table 7 RapidINTEL Sample Cartridge Stutter thresholds. When not indicated, the stutter threshold is –4 nucleotides from the allele peak. (continued) Marker Avg Stutter + 4SD (%) ™...

  • Page 57: Analysis Settings: Globalfiler ™ Express Sample Cartridges

    Appendix C Analysis settings Analysis settings: GlobalFiler ™ Express sample cartridges The Run Wizard screens are displayed with analysis settings. Click Next to display additional settings screens. ™ Analysis settings: GlobalFiler Express sample cartridges RapidHIT ™ ID System v1.3.1 User Guide...

  • Page 58: Analysis Settings: Rapidintel ™ Sample Cartridges

    Appendix C Analysis settings Analysis settings: RapidINTEL ™ sample cartridges ™ Analysis settings: RapidINTEL sample cartridges RapidHIT ™ ID System v1.3.1 User Guide...
  • Page 59 Appendix C Analysis settings Analysis settings: RapidINTEL ™ sample cartridges ™ Note: The screen above shows the Global Max Percentage for samples. For the RapidINTEL positive control, the setting is <30% . RapidHIT ™ ID System v1.3.1 User Guide...

  • Page 60: Analysis Settings: Ngm Select ™ Express Sample Cartridges

    Appendix C Analysis settings Analysis settings: NGM SElect ™ Express sample cartridges ™ Analysis settings: NGM SElect Express sample cartridges RapidHIT ™ ID System v1.3.1 User Guide...
  • Page 61 Appendix C Analysis settings Analysis settings: NGM SElect ™ Express sample cartridges RapidHIT ™ ID System v1.3.1 User Guide...

  • Page 62: Background

    Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) ■ Background ............... . . 62 ■...

  • Page 63: About The Systematic Allelic Ladder Library

    Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) About the Systematic Allelic Ladder Library About the Systematic Allelic Ladder Library ™ ™ The Systematic Allelic Ladder Library model was introduced for the RapidHIT ACE NGM SElect ™...
  • Page 64 Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) About the Systematic Allelic Ladder Library Figure 7 Square fit analysis ™ The square fit analysis shows the position of the allelic ladder library and samples from the RapidHIT ID System v1.2 ™...

  • Page 65: Study Overview

    Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) Study overview Study overview The performance of the Systematic Allelic Ladder Library was assessed for concordance and accuracy ™ ™ by re-analyzing the 361 runs from the original RapidHIT ACE NGM SElect Express Sample Cartridge ™...
  • Page 66 Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) Concordance Figure 8 Concordance The sample profile analyzed with the existing Allelic Ladder Library (pane A) indicated the presence of an OB allele at the SE33 locus. When the profile was reanalyzed using the Systematic Allelic Ladder Library (pane B), the OB resolved to the concordant allele designation.

  • Page 67: Accuracy

    Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) Accuracy Accuracy ™ To evaluate for accuracy, the performance of the Systematic Allelic Ladder Library in RapidHIT ™ System v1.2.1 was compared to the performance of the Empirical Allelic Ladder Library in RapidHIT System v1.2.

  • Page 68: Absolute Size Difference

    Appendix D Validation of the Systematic Allelic Ladder Library (ACE NGM sample cartridges only) Absolute size difference Absolute size difference Because allelic ladder selection is performed on a per-sample basis, the aggregate size difference between sample peaks and selected allelic ladder peaks was another method used to compare performance.

  • Page 69: Appendix E Software Verification Rapidhit ™ Id System V1.3.1

    ™ Software verification RapidHIT System v1.3.1 ■ Objective of the software verification ........... 69 ■...

  • Page 70: Studies, Standards, And Samples

    Appendix E Software verification RapidHIT ™ ID System v1.3.1 Studies, standards, and samples Studies, standards, and samples Test Parameter QAS Reference Samples Functionality 8.9.3.1 Control, allelic ladder, and sample runs were performed on ™ RapidHIT ID v1.3.1 across 2 instruments: 8.9.3.2 •...

  • Page 71: Functionality Testing Results

    Appendix E Software verification RapidHIT ™ ID System v1.3.1 Functionality testing results (continued) Test Parameter QAS Reference Samples Reliability 8.9.3.1 Sample runs: • 8 controls from the functionality study 8.9.3.2 • 10 samples from the functionality study Data reprocessing runs: •...
  • Page 72 Appendix E Software verification RapidHIT ™ ID System v1.3.1 Functionality testing results Samples The 10 ACE GFE sample cartridges met the defined thresholds and produced results. Some AB ™ RI sample cartridges produced results. These samples were evaluated in the RapidLINK Software v1.1.5.
  • Page 73 Appendix E Software verification RapidHIT ™ ID System v1.3.1 Functionality testing results Table 9 Runs performed to evaluate the functionality of the RapidHIT ID v1.3.1 system with samples and controls using ACE GlobalFiler Express and RapidINTEL sample and control cartridges. (continued) Details Sample Cartridge type...
  • Page 74 Appendix E Software verification RapidHIT ™ ID System v1.3.1 Functionality testing results Table 9 Runs performed to evaluate the functionality of the RapidHIT ID v1.3.1 system with samples and controls using ACE GlobalFiler Express and RapidINTEL sample and control cartridges. (continued) Details Sample Cartridge type...

  • Page 75: Regression Testing Results

    Appendix E Software verification RapidHIT ™ ID System v1.3.1 Regression testing results Regression testing results ™ Regression testing was performed to confirm that the software changes made in RapidHIT ID System v1.3.1 do not impact the software functionality. Twenty passing samples were selected to evaluate performance.
  • Page 76 Appendix E Software verification RapidHIT ™ ID System v1.3.1 Accuracy testing results Figure 11 Samples and positive controls processed with ACE GFE cartridges across two RapidHIT ID instruments. The size difference in bp is shown per marker running from the smallest to largest markers (bp).

  • Page 77: Reliability Testing Results

    Appendix E Software verification RapidHIT ™ ID System v1.3.1 Reliability testing results Figure 13 Samples and allelic ladders processed with NGM cartridges across two RapidHIT ID instruments. The size difference in bp is shown per marker running from the smallest to largest markers (bp). Data reprocessing The regression test data was evaluated for accuracy.

  • Page 78: Conclusion

    Appendix E Software verification RapidHIT ™ ID System v1.3.1 Conclusion Table 11 Test cases to evaluate the reliability of the RapidHIT ID v1.3.1 system. Functional and non-functional testing evaluated critical aspects of software performance. (continued) Performed as Category Test Expected (Y/N) •...

  • Page 79: Appendix F Safety

    Safety WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user documentation may result in personal injury or damage to the instrument or device. Ensure that anyone using this product has received instructions in general safety practices for laboratories and the safety information provided in this document.

  • Page 80: Location Of Safety Labels

    Appendix F Safety Symbols on this instrument Location of safety labels Figure 14 Rear panel CAUTION! Risk of danger. Consult the manual for further safety information. Figure 15 Primary cartridge CAUTION! The capillary is fragile. Handle the primary cartridge with care after you remove the capillary cover. Control and connection symbols Symbols and descriptions...

  • Page 81: Conformity Symbols

    Appendix F Safety Symbols on this instrument (continued) Symbols and descriptions Protective conductor terminal (main ground) Direct current Alternating current Both direct and alternating current Conformity symbols Conformity mark Description Indicates conformity with safety requirements for Canada and U.S.A. Indicates conformity with European Union requirements. Indicates conformity with the WEEE Directive 2012/19/EU.

  • Page 82: Safety Information For Instruments Not Manufactured By Thermo Fisher Scientific

    Appendix F Safety Safety information for instruments not manufactured by Thermo Fisher Scientific Safety information for instruments not manufactured by Thermo Fisher Scientific Some of the accessories provided as part of the instrument system are not designed or built by Thermo Fisher Scientific.

  • Page 83: Cleaning And Decontamination

    Appendix F Safety Instrument safety Cleaning and decontamination CAUTION! Cleaning and Decontamination. Use only the cleaning and decontamination methods specified in the manufacturer's user documentation. It is the responsibility of the operator (or other responsible person) to ensure the following requirements are met: ·...

  • Page 84: Safety And Electromagnetic Compatibility (Emc) Standards

    Appendix F Safety Safety and electromagnetic compatibility (EMC) standards Safety and electromagnetic compatibility (EMC) standards The instrument design and manufacture complies with the following standards and requirements for safety and electromagnetic compatibility. Safety standards Reference Description EU Directive 2014/35/EU European Union “Low Voltage Directive” IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use –...

  • Page 85: Environmental Design Standards

    Appendix F Safety Safety and electromagnetic compatibility (EMC) standards (continued) Reference Description ICES-001, Issue 4 Industrial, Scientific and Medical (ISM) Radio Frequency Generators FCC Part 15 Subpart B (47 CFR) U.S. Standard Radio Frequency Devices This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
  • Page 86 Appendix F Safety Safety and electromagnetic compatibility (EMC) standards (continued) Reference Description RFID Canada (English) CAN ICES-3(A) / NMB-3(A): This device complies with Industry Canada license-exempt RSS standards. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

  • Page 87: Chemical Safety

    Appendix F Safety Chemical safety Chemical safety WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel read and practice the general safety guidelines for chemical usage, storage, and waste provided below. Consult the relevant SDS for specific precautions and instructions: ·...

  • Page 88: Biological Hazard Safety

    Appendix F Safety Biological hazard safety Biological hazard safety WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents, and blood of humans and other animals have the potential to transmit infectious diseases. Conduct all work in properly equipped facilities with the appropriate safety equipment (for example, physical containment devices).

  • Page 89: Documentation And Support

    Documentation and support Related documentation Document Publication number RapidHIT ™ ID System v1.3.1 User Guide MAN0018938 ™ RapidLINK Software v1.1.5 User Guide MAN0018939 ™ RapidINTEL Sample Cartridge for Blood and Saliva Samples Validation MAN0018979 User Bulletin ™ ™ ™ RapidHIT ID ACE NGM SElect Express Sample Cartridge for RapidHIT MAN0018973...

  • Page 90: Limited Product Warranty

    Documentation and support Limited product warranty Limited product warranty Life Technologies Corporation and/or its affiliate(s) warrant their products as set forth in the Life Technologies' General Terms and Conditions of Sale at www.thermofisher.com/us/en/home/ global/terms-and-conditions.html. If you have any questions, please contact Life Technologies at www.thermofisher.com/support.
  • Page 91 Bibliography ® Hennessy LK et al. (2014). Developmental validation of the GlobalFiler express kit, a 24-marker STR ™ assay, on the RapidHIT System. Forensic Science International: Genetics (13): 247-258. ™ Buscaino J et al. (2018) Evaluation of a rapid DNA process with the RapidHIT ID system using a specialized cartridge for extracted and quantified human DNA.

  • Page 92: Index

    Index administrator permissions 31 network configuration and security 11 allelic ladder cartridge, run 44 Allelic Ladder Library, Systematic 62 analysis settings 54 operator permissions 31 back up 45 barcode password security 11 enter 20 power button, front panel 16 power requirements 49 scanner, optional USB 19 biohazard safety 88 primary cartridge...
  • Page 93 Index conformity 81 control and connection 80 Validation, Systematic Allelic Ladder Library 62 safety 79 system specifications 49 warranty 90 workflow 12 terms and conditions 90 troubleshooting 46 user permissions 31 roles 31 RapidHIT ™ ID System v1.3.1 User Guide...
  • Page 94 5RapidHIT ID v1.3.1 Expert System v1.0 UG_MAN0018938-v2-GUID-5152E141-9076-4DA9- B47B-1C3ADD78570B-2020/12/15 15:40:49 en 15:35:37.053Z thermofisher.com/support | thermofisher.com/askaquestion thermofisher.com 5 January 2021...

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