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

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

ThermoFisher Scientific Applied Biosystems RapidHIT ID System v1.3.1 Specifications

General

Manufacturer	Thermo Fisher Scientific
Sample Type	Buccal swabs
Analysis Time	90 minutes
Software	RapidHIT Software
Technology	Capillary Electrophoresis (CE)
Power Requirements	100-240 VAC, 50/60 Hz
Operating Temperature	15°C to 30°C (59°F to 86°F)
Humidity Range	20% to 80% relative humidity, non-condensing
Model	Applied Biosystems RapidHIT ID System v1.3.1

Summary

Product Information

Product Description

Describes the components of the RapidHIT ID System v1.3.1.

Sample Cartridge Types

Details the different types of sample cartridges available for the system.

Parts of the Instrument

Illustrates and labels the key physical components of the instrument.

Required Materials Not Supplied

Lists essential materials not included with the instrument kit.

Network and Password Security Requirements

Outlines responsibilities for network configuration, security, and password management.

Workflow

Provides a step-by-step overview of the instrument's operational process.

Collect and Prepare the Sample

Sample Collection: GlobalFiler Express and NGM SElect Express Sample Cartridges

Details sample collection procedures for specific cartridge types.

Sample Collection: RapidINTEL Sample Cartridges

Details sample collection procedures for RapidINTEL sample cartridges.

Run the Instrument to Generate a DNA Profile

Power On the Internal Computer

Instructions on how to power on the instrument's internal computer and system startup.

Sign In to the Instrument

Explains the process of signing into the instrument using various authentication methods.

Parts of the Sample Identification Screen

Identifies and explains the different elements visible on the sample identification screen.

Enter the Sample Identification Number

Describes methods for entering sample identification via barcode scanning or manual input.

Insert the Sample Cartridge into the Instrument (Automatically Starts the Run)

Details the procedure for inserting the sample cartridge to initiate an automated run.

Run Times for Different Sample Cartridges

Provides information on the expected run durations for various sample cartridge types.

Remove the Sample Cartridge from the Instrument

Outlines the steps for safely removing the sample cartridge after a run is complete.

Check the Run Result

Explains how to view and interpret the results displayed on the instrument.

View and Export the Run Results

Describes how to access, review, and export historical run data.

Sign Out

Details the procedure for manually signing out of the instrument.

Manage the Instrument and Software

View and Export the Run Results for All Runs (Administrator or Supervisor Only)

Guides administrators/supervisors on accessing and exporting all run data.

Configure Instrument Settings (Administrator or Supervisor Only)

Explains how to adjust instrument operational parameters and settings.

Manage Users (Administrator Only)

Outlines procedures for adding, managing, and authorizing users on the instrument.

Remove Authorization for an Instrument

Describes how to revoke a user's access to a specific instrument.

Maintain the Instrument

Routine Maintenance

Lists regular tasks required to keep the instrument in optimal working condition.

View Primary Cartridge Information

Explains how to check the status and details of the primary cartridge.

Parts of the Primary Cartridge

Illustrates and labels the components of the primary cartridge before preparation.

Prepare a New Primary Cartridge

Details the steps and components needed to prepare a new primary cartridge.

Insert the Prepared Primary Cartridge (Administrator or Supervisor Only)

Guides on inserting the prepared primary cartridge into the instrument.

Run a Control Cartridge

Details the process for running control cartridges for quality assurance.

Back Up and Restore Data (Administrator Only)

Explains how to back up instrument data to a USB device and restore it.

Recover the Instrument (Administrator or Supervisor Only)

Guides on resetting the instrument's hardware to a default state.

Prepare the Instrument for Shipping

Provides instructions for preparing the instrument for transport or shipping.

Troubleshooting

Check the RapidLINK Software Connection

Offers guidance on diagnosing and resolving issues with software connectivity.

Troubleshooting: Symptoms, Causes, and Actions

Provides a reference guide for identifying and resolving common instrument problems.

Instrument Specifications

Dimensions, Clearance, and Weight

Lists the physical size and weight specifications of the instrument.

Instrument Layout and Connections

Illustrates the instrument's physical arrangement and external connection points.

Environmental Requirements

Specifies the operating and storage conditions necessary for the instrument.

Electrical Requirements

Details the power supply, voltage, and other electrical needs for the instrument.

Analysis Settings

Threshold Settings

Defines the critical threshold values used for DNA profile analysis.

Display Analysis Settings in the GeneMarker HID STR Human Identity Software

Explains how to view and configure analysis parameters within the GeneMarker software.

Analysis Settings: GlobalFiler Express Sample Cartridges

Specifies the analysis configuration for GlobalFiler Express sample cartridges.

Analysis Settings: RapidINTEL Sample Cartridges

Specifies the analysis configuration for RapidINTEL sample cartridges.

Analysis Settings: NGM SElect Express Sample Cartridges

Specifies the analysis configuration for NGM SElect Express sample cartridges.

Validation of the Systematic Allelic Ladder Library (ACE NGM Sample Cartridges Only)

Background

Provides context on allele sizing and variation in DNA analysis.

About the Systematic Allelic Ladder Library

Explains the purpose and function of the Systematic Allelic Ladder Library.

Study Overview

Summarizes the methodology and scope of the validation study.

Concordance

Presents results showing agreement between different analysis methods.

Accuracy

Details the precision and correctness of allele measurements.

Absolute Size Difference

Analyzes size differences between sample and ladder peaks for genotyping accuracy.

Conclusion

Summarizes the findings of the allelic ladder library validation study.

Software Verification RapidHIT ID System v1.3.1

Objective of the Software Verification

States the goals of the software validation process.

Studies, Standards, and Samples

Describes the testing methodology, standards, and samples used in the study.

Functionality Testing Results

Reports the outcomes of tests verifying core software functions.

Regression Testing Results

Details results from tests ensuring software changes did not affect existing functionality.

Accuracy Testing Results

Presents findings on the software's accuracy in DNA analysis.

Reliability Testing Results

Reports on the stability and consistency of the software's performance.

Conclusion

Summarizes the overall findings of the software verification study.

Safety

Symbols on this Instrument

Explains various hazard and information symbols found on the instrument.

Standard Safety Symbols

Details common safety symbols and their meanings.

Location of Safety Labels

Identifies where safety labels are placed on the instrument.

Control and Connection Symbols

Explains symbols related to instrument controls and connections.

Conformity Symbols

Shows symbols indicating compliance with regulatory standards.

Safety Information and Precautions

Covers general, physical, and electrical safety for the instrument.

Cleaning and Decontamination

Provides guidelines for safely cleaning and decontaminating the instrument.

Instrument Component and Accessory Disposal

Offers guidance on the proper disposal of instrument parts and accessories.

Laser Safety

Details precautions and warnings related to the instrument's laser system.

Safety and Electromagnetic Compatibility (EMC) Standards

Lists standards and directives related to safety and EMC compliance.

Environmental and Radio Compliance

Covers environmental design standards and radio compliance regulations.

Chemical Safety

Provides essential guidelines for handling chemicals safely.

Biological Hazard Safety

Outlines precautions for working with biological samples and hazards.

Documentation and Support

Related Documentation

Lists other relevant documents for the system and software.

Customer and Technical Support

Provides contact information and resources for obtaining technical assistance.

Limited Product Warranty

Outlines the terms and conditions of the product warranty.