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IRIS iChemVelocity

IRIS iChemVelocity
238 pages
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1. Introduction
Operator’s Manual

Table of Contents

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IRIS iChemVelocity Specifications

General IconGeneral
ThroughputUp to 400 tests per hour
Power Requirements100-240 VAC, 50/60 Hz
Sample TypeSerum, Plasma, Urine
ISE ModuleOptional
ConnectivityEthernet
Operating Temperature15 to 30°C
Operating Humidity20-80%

Summary

1 Introduction

Intended Use

Defines the intended use of the iChemVELOCITY system for automated urine chemistry analysis.

How to Use the Operators Manual

Provides guidance on effectively using the Operator's Manual for system operation and troubleshooting.

Precautions and Warnings

Highlights safety information, including tips, notes, cautions, and warnings for safe system operation.

Biological Warnings

Advises on safe handling of specimens and test strips to prevent pathogen exposure.

Iris Diagnostics Contact Information

Provides contact details for Iris Diagnostics for customer support and feedback.

Symbols

Explains the meaning of various symbols used on product labeling and the instrument.

Warnings, Precautions, Limitations

Lists essential warnings, precautions, and limitations for safe and proper instrument operation.

Precautions and Safety

Details critical safety measures for instrument setup, handling, power, and environmental conditions.

Requirements

Specifies the environmental and electrical requirements for the iChemVELOCITY system installation and operation.

Installation

States that installation will be performed by a factory-trained representative.

Warranty

Outlines the terms and duration of the product warranty provided by Iris Diagnostics.

Limitation of Liability

Defines the limitations of liability for Iris Diagnostics regarding product use and damages.

2 System Description

Theory of Operation

Explains how the iChemVELOCITY system automates urine chemistry analysis using wavelength reflectance.

Measurements

Details the analytes measured and the methods used, including specific gravity, color, and clarity.

System Components

Describes the key components of the iChemVELOCITY system, such as the sampler and barcode reader.

Sampler

Explains the function of the sampler in moving test tube racks for analysis.

Barcode Reader

Details how the barcode reader identifies samples and provides patient identification data.

Load and Unload Stations

Describes the capacity and function of stations for loading and unloading test tubes.

Optional Load and Unload Stations

Details the increased capacity when optional load/unload stations are connected.

Strip Provider Module

Describes the strip provider module's capacity, stability, and function in delivering test strips.

Strip Conveyor System

Explains the system that moves test strips through various positions for analysis.

Strip Reader Module

Details how the module measures strip pad colors to determine analyte concentrations.

Specific Gravity, Color, and Clarity Module

Refers to sections detailing specific gravity, color, and clarity measurement modules.

Fluidics

Describes the fluid handling systems including the sample probe, wash station, and pumps.

Sample Probe

Explains the function of the sample probe in mixing, aspirating, and dispensing samples.

Wash Station

Describes the function of the wash station in rinsing and discarding wash solution.

Pumps

Details the pumps used for sample aspiration, dispensing, and cleaning fluidics.

Wash Container

Specifies the wash container and its capacity for supplying wash solution.

Waste

Covers waste management including strip disposal and liquid waste disposal.

Strip Disposal

Explains the automatic disposal of used test strips into a waste container.

Liquid Waste Disposal

Describes how liquid waste is discarded into a drain or a waste container.

On Button

Details the location and function of the ON button for placing the system in Standby.

System Status Lights

Explains the meaning of the system status lights (Green, Blue, Red) and their combinations.

Racks

Describes the four types of racks used with the iChemVELOCITY system: sample, control, CalChek, and dilution.

Sample rack

Explains how patient samples are presented in sample racks.

Control rack

Details the use of control racks for chemistry controls.

CalChek rack

Describes CalChek racks for calibration checks of SG, Color, and Clarity.

Dilution rack

Explains the use of the dilution rack for samples requiring microscopy after processing.

Test Strips

Describes the reagent-impregnated pads on test strips for chemical analysis.

Test Specifications

Details packaging and compatibility requirements for iChemVELOCITY Urine Chemistry Strips.

Peripherals

Lists and describes peripherals connected to the system, including keyboard, mouse, monitor, and printer.

Keyboard

Explains the keyboard's use for entering specimen identifiers and data.

Mouse

Describes the mouse's function for navigating software screens.

Monitor

Explains the monitor's use for making selections on software screens.

Printer

Details the connection of a compatible printer via a USB port.

Software Functions

Outlines the software's capabilities, including mechanical control, automatic analysis, and user interface management.

iChemVELOCITY Status

Describes the status indicators on the screen, including lights, operator ID, and alarm information.

View Selector

Explains how to access different screens (Specimen, Work List, Instrument) using the view selector.

Instrument Screen

Details the elements of the Instrument screen, including status, operator, and information panes.

Shift Summary

Presents a summary of operator, calibration checks, QC, LIS status, manual orders, and system status.

Alarms

Explains how alarms appear in the information area and are sorted by priority and date/time.

Screen Level Functions

Lists and describes the functions available via buttons on the screen, such as Manual Orders, Consumables, and Maintenance.

Work List

Describes the Work List screen, which displays unreleased results and allows sorting and searching.

Found List Screen

Explains the Found List screen for reviewing released results after a search.

Sort Work List

Details how to sort the Work List by various criteria like Specimen ID or Date/Time.

Delete Specimen

Describes the process for deleting specimen results from the Work List or Found List.

Un-Delete Specimen

Explains how to restore deleted specimen results back to the Work List.

Correct Specimen ID

Allows managers to correct specimen IDs, and any logged-in user to correct IDs with errors.

Edit Demographics

Explains how to add or edit patient demographic information for specimens.

Print List

Describes the function to print the entire Work List.

Re-Report

Details the function to re-report specimen results that have already been released.

Search

Explains how to search archived specimen results using various criteria.

Search by specimen ID

Describes how to search for specimens using their ID, either individually or within a range.

Search by Sequence Number

Details how to search for specimens based on their sequence number.

Search by Operator ID

Explains how to search for specimens released by a specific operator or all operators.

Search by date-time (range)

Describes how to search for specimens processed within a specific date and time range.

Search by Demographics

Explains how to search for specimens based on demographic information like last name, first name, age, and location.

Age

Details how to search for specimens based on patient age or age range.

Specific Location

Explains how to search for specimens based on location, matching LIS terminology.

Search with a Combination of Parameters

Describes how to perform searches using multiple criteria simultaneously.

Show specimens awaiting transmission only

Option to filter search results for specimens pending transmission.

Show released specimens only

Option to filter search results for specimens that have already been released.

Show incomplete specimens only

Option to filter search results for specimens pending completion.

Clear Button

Removes previously entered search parameters from the search fields.

Flagged Specimens

Explains how flags are indicated in the status column and how to view flagged specimens.

Review Flagged Specimen button

Allows review of flagged specimens to clear flags and prepare for auto-release.

Delete Flagged Specimen button

Prepares a flagged specimen for deletion, requiring resolution of the flag cause.

Chemistry System Flag Messages

Details common flag messages like CHEMTRANSLATE and CHEM CONFIRM, with remedies.

CHEMTRANSLATE

Flag indicating mismatch between chemistry names/results and input settings.

CHEM CONFIRM

Flag indicating results exceeded the user-defined confirmation threshold.

IDError

Indicates a failure by the barcode reader to read a specimen's barcode label.

Processing Failure

Signifies an internal error detected by the system during processing.

Processing not complete

Indicates an internal irrecoverable error, stopping new specimen processing.

S1

Error related to instrument self-calibration failure with iChem Wash Solution.

S2

Error related to the Color Clarity Specific Gravity module.

S3

Normal condition where Specific Gravity result is >1.060.

1.000

Normal condition where Specific Gravity result is <1.000.

Specimen Screen

Displays detailed specimen results, including chemistry results, comments, and audit trail.

Accessing the Specimen Screen

Explains how to navigate to the Specimen screen from the Work List.

Specimen Screen Buttons

Describes buttons on the Specimen screen like Delete Flagged Specimen, Review Flagged Specimen, Accept, Skip, Edit, and Work List/Found List.

Editing Results

Details how to edit Chemistry and Microscopy results, requiring 'Enable Detail Audit Trail'.

Editing a Chemistry Result Value

Provides steps for editing specific chemistry result values for specimens.

Entering Manually a Microscopy Result Value

Explains how to manually enter microscopy results associated with chemistry results.

3 Setup

Settings Screen

Describes how to access and view user-defined instrument settings.

Accessing a Setup Screen

Explains how to navigate to specific setup screens for configuration.

Printing the Setup

Details how to print the current instrument settings.

View Log

Explains how to access the settings log to review changes made to settings.

Restore Button

Describes restoring setting changes directly from the View Log.

Restore Button

Details restoring settings from an external source like a USB drive.

Save as Button

Explains how to save setting changes to an external source for backup.

Viewing the Saved Settings

Guides on how to view saved settings and convert them to XML format.

Operator Accounts Settings

Manages authorized users and their privilege levels (Technologist or Manager).

Adding a New Operator

Provides steps to add new users with specified identifiers, passwords, and privilege levels.

Deleting an Operator

Details the process for removing existing operator accounts.

Modifying an Operator

Explains how to modify operator information by deleting and re-adding the user.

Laboratory Information Settings

Allows entry of laboratory-specific information for display on reports.

System Configuration Settings

Configures system presence (microscopy/chemistry) and reporting units.

Chemistry System Present

Enables and configures the presence of a chemistry system, potentially alongside a microscopy module.

Enter Primary Chemistry Settings

Guides on setting up the primary chemistry system configuration and its parameters.

Enter Backup Chemistry Settings

Details the process for configuring a backup chemistry system for redundancy.

Validating the Changes

Explains how to confirm system configuration changes and the need for a restart.

LIS Interface Settings

Configures communication settings for the Laboratory Information System (LIS).

Enable LIS

Describes how to enable communication with the LIS by checking a specific box.

Communication settings

Allows selection of specific communication settings for the LIS through dropdown menus.

Specimen information from LIS

Options for obtaining specimen information and demographics from the LIS.

Skip Specimen if LIS Fails

Determines if specimens should be skipped if LIS communication fails.

Obtain Patient Demographics Information from LIS

Enables fetching patient demographics data from the LIS.

Demographics

Allows selection of required demographic fields for LIS data retrieval.

Fluid Type - Formed Particles

An option available when an iQ Series microscopy module is connected.

Chemistry Settings

Allows configuration of chemistry-specific information like names, units, and thresholds.

Editing Chemistry Settings

Guides on editing chemistry abbreviations, long names, and units.

Editing Chemistry Values

Details how to modify input/output values, moving, changing, or deleting them.

Validating the changes

Confirms changes made to chemistry settings and the need for system restart.

QC Settings

Configures automatic sending of control results to printer or LIS.

REF Override Settings

An option available for iQ Series microscopy module configuration.

Specimen Settings

Controls whether barcode scan failures are flagged or not.

Flag barcode scan failures

Determines if barcode scan failures are flagged as ID_ERROR.

Enable detailed audit trail

Logs changes made to results, including the user who made them.

Report operator [auto]

Sets username to [Auto] for auto-released results or displays the logged-in user.

Release Settings

Selects the destination for releasing results (Printer or LIS).

Urine Gating Settings

Option available for iQ Series microscopy module configuration.

Urine Auto-Release Settings

Option available for iQ Series microscopy module configuration.

Urine Auto-Classify Settings

Option available for iQ Series microscopy module configuration.

Sequence Number

Assigns a sequence number to samples and displays/prints it on reports.

4 Sample Processing

Logon

Explains the logon process and how it activates specimen, worklist, and instrument functions.

Specimen Preparation

Provides guidelines for collecting, storing, and preparing urine specimens for analysis.

Specimens at Room Temperature

Emphasizes the importance of testing specimens at room temperature for accurate results.

Gross Hematuria

Notes that manual methods should be used for gross hematuria.

Specimen Volume

Specifies the minimum required specimen volume for analysis by the iChemVELOCITY.

Sample Tube Specifications

Details the dimensions and examples of acceptable sample tubes for the system.

Preparing Sample Racks

Provides instructions on applying barcode labels and loading tubes into sample racks.

Barcode Labels

Specifies accepted barcode types and orientation guidelines for proper reading.

Manual Orders

Allows manual entry of a Work List for chemistry analysis when LIS is unavailable.

Accessing Manual Orders

Explains how to navigate to the Manual Orders menu from the Instrument screen.

Entering Manual Orders

Guides on selecting rack numbers and entering specimen information for manual orders.

Clearing Specimen Information

Describes how to clear specimen information from the Manual Orders screen or the Instrument screen.

Running Samples

Provides steps for running samples, including QC checks and sample loading.

Consumables

Discusses replenishment of consumables without stopping measurements.

Loading Urine Chemistry Strips

Details the procedure for loading urine chemistry strips into the strip loader.

Replacing Wash Solution Container and Wash Solution Filter

Explains how to replace the wash solution container and filter when the wash level is low.

Consumables Part Numbers

Lists part numbers for consumables like test strips, wash solution, and control kits.

5 Quality Control

Control Material

Describes the use of Urine Control CA/CB/CC for checking system condition and accuracy.

Handling QC Material

Provides storage recommendations for QC materials, including refrigeration after opening.

Control Frequency

Specifies the recommended frequency for running controls, typically every 24 hours.

QC Settings

Refers to the Consumables Traceability chapter for QC settings.

Running QC

Details the steps and required items for performing a quality control run.

QC Failure

Outlines troubleshooting steps and actions to resolve QC failures.

Reviewing Quality Controls Results

Explains how to review and interpret QC results using the Quality Review screen.

Print List button

Prints all QC results currently listed on the Quality Review screen.

Re-Report button

Allows re-reporting of selected QC results, with destination options.

Remove

Allows managers to remove erroneous QC results with documentation.

Search button

Accesses the Quality Search screen to find QC data using specific criteria.

Lot field

Displays control lot information in the QC search criteria.

Type field

Displays control types (CA/CB/CC, SG/Color/Clarity, Reflectance) in QC search.

Status field

Displays the status (passed-failed) of QC results in the search criteria.

Date-time combo-box

Enables date and time range selection for QC searches.

Save Button

Allows saving QC results for long-term storage in HTML format.

QC Report

Details how to review and generate QC reports, including control name, lot ID, and analyte results.

Print Button

Sends the QC report to the printer.

Save Button

Saves QC results for long-term storage in HTML format.

Saving all QC Results

Guides on saving all QC results to external media for long-term storage.

Saving a Specific QC Result

Details how to save an individual QC result for long-term storage.

QC Statistics

Explains how to view QC statistics, including charts and reports for specific lot numbers.

QC Definitions

Defines statistical terms used in QC, such as Mean, Standard Deviation, Coefficient of Variation, and Target Value.

6 Calibration Verifications

Calibration Check Material

Describes calibration check materials like Reflectance CalChek test strips and CalChek Reagents.

Reflectance CalChek test strips

Details the use of CalChek strips for reflectance calibration checks.

CalChek Reagents

Describes Specific Gravity, Color, and Clarity CalChek solutions.

Specific Gravity CalChek solutions

Lists the SG CalChek solutions and their specific gravities.

Color CalChek solutions

Describes the color controls for CalChek, including their colors.

Clarity CalChek solutions

Details the clarity controls for CalChek and their clarity values.

Storage and Use

Refers to package inserts for information on product storage and use.

CalCheks Frequency

Specifies that CalCheks should be performed quarterly or after instrument relocation.

Running CalChek

Explains how to run the Reflectance CalChek procedure for instrument calibration verification.

Reflectance CalChek

Details the Reflectance CalChek procedure, including steps and notes.

Specific Gravity, Color, and Clarity CalChek

Describes the procedure for performing SG/Color/Clarity CalCheks.

CalChek Failure

Provides troubleshooting steps for Reflectance and SG/Color/Clarity CalChek failures.

Reflectance CalChek Failure

Outlines remedies for Reflectance CalChek failures, including repeating the check.

SGColorClarity CalChek Failure

Provides remedies for SG/Color/Clarity CalChek failures, including repeating the check.

7 Results

Results Interpretation

Explains that microscopy and chemistry tests are complementary and should be used for comprehensive evaluation.

Reviewing Results

Describes how to review unreleased results using the Work List and released results using the Found List.

Work List Screen

Details the Work List screen, displaying unreleased results and allowing identification of flagged specimens.

Found List Screen

Explains the Found List screen for reviewing released results after a search.

Sort Work List

Details how to sort the Work List by various criteria like Specimen ID or Date/Time.

Delete Specimen

Describes the process for deleting specimen results from the Work List or Found List.

Un-Delete Specimen

Explains how to restore deleted specimen results back to the Work List.

Correct Specimen ID

Allows managers to correct specimen IDs, and any logged-in user to correct IDs with errors.

Edit Demographics

Explains how to add or edit patient demographic information for specimens.

Print List

Describes the function to print the entire Work List.

Re-Report

Details the function to re-report specimen results that have already been released.

Search

Explains how to search archived specimen results using various criteria.

Search by specimen ID

Describes how to search for specimens using their ID, either individually or within a range.

Search by Sequence Number

Details how to search for specimens based on their sequence number.

Search by Operator ID

Explains how to search for specimens released by a specific operator or all operators.

Search by date-time (range)

Describes how to search for specimens processed within a specific date and time range.

Search by Demographics

Explains how to search for specimens based on demographic information like last name, first name, age, and location.

Age

Details how to search for specimens based on patient age or age range.

Specific Location

Explains how to search for specimens based on location, matching LIS terminology.

Search with a Combination of Parameters

Describes how to perform searches using multiple criteria simultaneously.

Show specimens awaiting transmission only

Option to filter search results for specimens pending transmission.

Show released specimens only

Option to filter search results for specimens that have already been released.

Show incomplete specimens only

Option to filter search results for specimens pending completion.

Clear Button

Removes previously entered search parameters from the search fields.

Flagged Specimens

Explains how flags are indicated in the status column and how to view flagged specimens.

Review Flagged Specimen button

Allows review of flagged specimens to clear flags and prepare for auto-release.

Delete Flagged Specimen button

Prepares a flagged specimen for deletion, requiring resolution of the flag cause.

Chemistry System Flag Messages

Details common flag messages like CHEMTRANSLATE and CHEM CONFIRM, with remedies.

CHEMTRANSLATE

Flag indicating mismatch between chemistry names/results and input settings.

CHEM CONFIRM

Flag indicating results exceeded the user-defined confirmation threshold.

IDError

Indicates a failure by the barcode reader to read a specimen's barcode label.

Processing Failure

Signifies an internal error detected by the system during processing.

Processing not complete

Indicates an internal irrecoverable error, stopping new specimen processing.

S1

Error related to instrument self-calibration failure with iChem Wash Solution.

S2

Error related to the Color Clarity Specific Gravity module.

S3

Normal condition where Specific Gravity result is >1.060.

1.000

Normal condition where Specific Gravity result is <1.000.

Specimen Screen

Displays detailed specimen results, including chemistry results, comments, and audit trail.

Accessing the Specimen Screen

Explains how to navigate to the Specimen screen from the Work List.

Specimen Screen Buttons

Describes buttons on the Specimen screen like Delete Flagged Specimen, Review Flagged Specimen, Accept, Skip, Edit, and Work List/Found List.

Editing Results

Details how to edit Chemistry and Microscopy results, requiring 'Enable Detail Audit Trail'.

Editing a Chemistry Result Value

Provides steps for editing specific chemistry result values for specimens.

Entering Manually a Microscopy Result Value

Explains how to manually enter microscopy results associated with chemistry results.

8 Maintenance & Service

Maintenance

Covers routine and periodic maintenance tasks for the iChemVELOCITY system.

Precautions

Highlights universal precautions for handling contaminated materials during maintenance.

Daily Maintenance

Details daily maintenance tasks such as emptying waste containers and cleaning instrument surfaces.

Emptying and cleaning the Waste Container

Provides steps for emptying and cleaning the waste container after specific intervals.

Discarding Liquid Waste

Explains the proper procedure for discarding liquid waste from the instrument.

Cleaning the Sample Transport Module

Details how to clean the sample transport module to remove deposits.

Cleaning the Optional LoadUnload Trays

Provides steps for cleaning the optional load/unload trays.

Cleaning the Instrument Surfaces

Explains how to clean the exterior surfaces of the instrument.

Consumable Replacement

Notes that consumables can be replaced while the instrument is running or in standby.

Weekly Maintenance

Outlines weekly maintenance tasks, including cleaning the strip provider module.

Cleaning the Strip Provider Module

Details the procedure for cleaning the strip provider module based on system throughput.

Monthly Maintenance

Covers monthly maintenance tasks, such as cleaning the wash station bath and strip conveyor system.

Cleaning the Wash Station Bath

Provides steps for cleaning the wash station bath using cotton swabs and deionized water.

Cleaning the Strip Conveyor System

Details the procedure for cleaning the strip conveyor system by dipping it in soapy water.

Quarterly Maintenance

Outlines quarterly maintenance tasks, including performing Reflectance and SG/CC CalCheks.

Perform Reflectance CalChek

Refers to the Calibration Verifications chapter for performing Reflectance CalChek.

Perform SGCC CalChek

Refers to the Calibration Verifications chapter for performing SG/CC CalChek.

Replacing Wash Solution Container and Wash Solution Filter

Refers to a previous section for replacing wash solution components.

As Needed Maintenance

Covers maintenance tasks that should be performed only when necessary.

Cleaning the Sample Tube Detector

Details cleaning the tube detector window if tubes are missing.

Cleaning the Barcode Reader Window

Provides steps for cleaning the barcode reader window.

Cleaning the Optical Sensors on the Sample Transport Module

Explains how to clean the optical sensors on the sample transport module.

Preparation for Long Term Shutdown

Details procedures for preparing the system for shutdown exceeding one week to prevent damage.

Start-up after Long term Shutdown

Provides instructions for starting up the system after a prolonged shutdown period.

Prime the System Lines

Explains how to prime the system lines using a control rack and diluent.

Run CalChek

Refers to running CalChek procedures.

Run Control Rack

Refers to running the control rack for QC.

Accessing the Maintenance Menu

Guides on how to access the Maintenance menu from the Instrument screen.

Maintenance options

Lists and describes various maintenance options available in the menu.

Reflectance Check

Allows running a Reflectance Calibration Check.

Chemistry Service

Reserved for Service Technicians.

Auto Strip Counter Override

Resets the software counter for discarded test strips.

Backup

Details the procedure for backing up instrument configuration and data.

Restore

Allows restoring instrument configuration and results from a backup.

System Info

Describes the system identifier, software version, and accessioned specimens.

Tallies

Allows obtaining detailed information on tests and controls run over a period.

Errors

Displays an error log of the chemistry system.

Shutdown

Explains how to shut down the instrument and software.

Restart button

Restarts only the user interface software for changes or error resolution.

Defragment button

Optimizes computer performance by defragmenting the drive.

Check Disk button

Scans the disk for errors and corrects them.

Auto Strip Counter Override

Resets the software counter for discarded test strips.

Backup

Details the procedure for backing up instrument configuration and data to external media.

Restore Procedure

Guides on restoring instrument configuration and data from backup media.

System Info

Displays system identifier, software version, and specimen accession count.

Tallies

Provides detailed information on tests and controls run over a specific period.

Errors

Displays an error log of the chemistry system.

Shutdown

Explains the procedure for shutting down the instrument and software.

Restart button

Restarts only the user interface software for changes or error resolution.

Defragment button

Optimizes computer performance by defragmenting the drive.

Check Disk

Scans the disk for errors and corrects them.

Alarm Messages

Lists common alarm messages, their causes, and remedies for the iChemVELOCITY system.

Alarm 17

Alarm for too many unreleased results in memory.

Alarm 18

Alarm for having too many unreleased results in memory.

Alarm 19

Alarm indicating failure to communicate with the LIS.

Alarm 21

Alarm indicating a setting change requiring restart or a system error.

Alarm 36

Alarm indicating an error in the Chemistry System.

Alarm 37

Alarm for failure to pass QC controls.

Alarm 40

Alarm indicating failure of the Reflectance Calibration Check.

Alarm 41

Alarm indicating failure of the SG/Color/Clarity Calibration Check.

Alarm 42

Alarm indicating low wash solution level.

Alarm 43

Alarm indicating the system is out of test strips or a strip jam.

Alarm 44

Alarm indicating the waste strip container is full.

Alarm 45

Alarm indicating the chemistry strip waste container may be full.

Alarm 46 to 69

Refers to alarm messages related to consumables.

Troubleshooting

Provides guidance on diagnosing and resolving common system issues.

Test Strip Jam

Details troubleshooting steps for test strip jams in the strip provider module.

Strip Provider Module Jam

Explains how to clear a jam in the strip provider module.

Strip Conveyor Module Jam

Provides troubleshooting for jams occurring on the strip conveyor module.

Rack Jam

Describes how to resolve issues when a rack cannot enter the sampling position.

Switching from Primary to Backup Chemistry System

Guides on switching to a backup chemistry system if the primary system is not functioning.

Switching from Backup to Primary Chemistry System

Explains how to switch back to the primary chemistry system after it has been restored.

Accessing Internal Components

Details how to access internal components for maintenance or troubleshooting.

Accessing the Strip Provider Module

Provides step-by-step instructions for accessing the strip provider module.

Accessing the Strip Conveyor Module

Details the procedure for accessing the strip conveyor module for cleaning or jam clearance.

Maintenance Log

Provides a template for logging daily, monthly, and as-needed maintenance activities.

9 iWARE Expert System

Data Management

Explains the Data Management function for applying filtering rules to results.

Rule Generator

Describes how to create customized rules for managing and filtering results.

Building Custom Rules Screen

Details the screen used for defining and managing custom rules.

Rule Button

Displays the last selected rule, its conditions, and associated tags.

Tagging Button

Accesses the Configuring Rules Tags screen.

SQL Button

Intended for IT personnel to view rules in programming language.

Add Condition Button

Adds and specifies the position of a filtering condition to a selected rule.

Delete Conditions Button

Specifies conditions to be deleted from a selected rule.

Make Usable Button

Confirms filtering conditions when imported rules are not compatible with system setup.

Import Button

Imports pre-populated rules created by Iris Diagnostics.

Create Button

Creates an unnumbered rule with user-defined fields and conditions.

Delete Button

Deletes the selected rule after displaying a warning.

Save As Button

Saves selected rule parameters to an empty selection or overwrites an existing rule.

Save Button

Saves the selected rule after changes have been made.

Import Pre-Populated Rules

Guides on importing rules created by Iris Diagnostics into the system.

Creating Customized Rules

Explains how to manually create customized rules specific to the laboratory.

Creating a New Numbered Custom Rule

Details creating numbered rules that can be tagged.

Creating a New Unnumbered Rule

Describes creating unnumbered rules for customized search criteria.

Adding one Condition

Guides on adding a single filtering condition to a rule.

Adding More Conditions to a Rule

Explains how to add multiple conditions to a rule using AND/OR logic.

Deleting a Condition from a Rule

Details how to delete specific conditions from a rule.

Saving a Rule

Explains how to save the selected rule after making changes.

ResultsRules Tagging

Applies filtering rules to specimen results and takes actions based on user tagging selection.

Tagging Options

Lists available tags: Validation Flag, Info Pane, LIS, and Report tagging.

Validation Flag

Prevents auto-release of results if selected for a rule and conditions match.

Info Pane Tagging

Signals in the Information pane for the operator to review the sample.

LIS Tagging

Provides specific messages to be sent to the LIS.

Report Tagging

Incorporates reporting tags for displayed and printed reports.

Tagging Using the Tagging Button

Guides on using the Tagging button to apply tagging to rules.

Tagging from the Building Custom Rules Screen

Allows tagging rules directly from the Building Custom Rules screen.

Report Generator

Enables creation of detailed, customized reports using search and data management criteria.

Search with Additional Criteria

Adds criteria from Data Management rules to the Search screen for advanced reporting.

Data Management Results

Shows results of data management operations, including patient reports with tags.

Patient Report with Tag

Example of a patient report showing rule output, comments, and rule modification status.

10 Consumables Traceability

Consumables Traceability

Allows tracking of system consumables and verifying lot usage.

Consumables Information

Provides information on calibration, controls, wash solution, and test strips.

Entering Consumables Data

Explains automatic entry via barcodes and manual entry for consumables.

Chemistry QC Consumables

Allows entry of strip lot information and QC data for each analyte.

Consumables Traceability Screen

Displays consumables traceability data and allows printing or saving reports.

Print Button

Prints the consumables list.

Save As Button

Saves consumables traceability data to a file.

Add Button

Adds a new consumable record to the traceability list.

Update Button

Edits an existing consumable record.

OK Button

Validates entries and returns to the Consumables window.

Cancel Button

Cancels entries or changes and returns to the Consumables window.

Adding a New Consumable

Details the fields required for documenting new consumables.

Editing a Consumable

Explains how to edit fields for an existing consumable record.

Deleting a Consumable

Describes how to delete a consumable record and enter a deletion comment.

Consumables Report

Explains how to print the consumables list for reporting.

Use of Expired Material

Explains software detection of expired QC/Calibration material and chemistry strips.

Quality Control Calibration Material

Details how expired QC/calibration material usage is indicated and handled.

Chemistry Test Strips

Lists alarm messages related to expired chemistry test strips.

Alarm 50

Alarm for expired IRISpec CA™ control material.

Alarm 51

Alarm for expired IRISpec CB™ control material.

Alarm 52

Alarm for expired IRISpec CC™ control material.

Alarm 54

Alarm for expired chemistry strip.

Alarm 59

Alarm for expired IRISpec CA™ control material, with override option.

Alarm 60

Alarm for expired IRISpec CB™ control material, with override option.

Alarm 61

Alarm for expired IRISpec CC™ control material, with override option.

Alarm 63

Alarm for expired chemistry strip, with override option.

Alarm 66

Alarm for expired SG/Color Clarity control material.

Alarm 67

Alarm for expired SG/Color Clarity control material, with override option.

Alarm 68

Alarm for expired Reflectance Check control material.

Alarm 69

Alarm for expired Reflectance Check control material, with override option.

Expired Consumable Lockout Override

Allows managers to override lockouts for expired consumables.

Accessing the Expired Consumable Lockout Override Option

Guides on how to access and enable the expired consumable lockout override function.

Consumables Search

Allows searching for consumables based on lot number and displaying usage information.

11 Appendix

Performance Characteristics

Describes the analytical performance and agreement of the iChemVELOCITY system.

Analytical Performance

States the system demonstrates >95% agreement within +/- 1 color block.

Analytes Report Ranges (Includes pH and Specific Gravity)

Lists report ranges for various analytes in conventional, SI, and qualitative units.

Protein

Provides report ranges for Protein in different units.

Blood (Hemoglobin)

Lists report ranges for Blood (Hemoglobin) in different units.

pH

Provides report ranges for pH values.

Nitrite

Lists report ranges for Nitrite.

Leukocytes

Provides report ranges for Leukocytes.

Ascorbic Acid

Lists report ranges for Ascorbic Acid.

Specific Gravity

Provides report ranges for Specific Gravity.

Color and Clarity Report Ranges

Lists color and clarity descriptions and their associated values.

Colors

Lists the descriptions for urine color: Colorless, Straw, Yellow, Amber, Red, Blue.

Clarity

Lists the descriptions for urine clarity: Clear, Slightly Cloudy, Cloudy, Turbid.

Sensitivity and Measurement Range

Details the analytical sensitivity and measuring range for various urine analytes.

Analytical Sensitivity

Defines analytical sensitivity as the concentration giving a positive result for 67% of samples.

iChemVELOCITY Urinalysis System

Compares the performance of the iChemVELOCITY system with commercially available urinalysis systems.

Method Comparison

Presents data on exact and +/- 1 grade agreement for various analytes compared to another system.

Expected Values and Ranges

Refers to package inserts for expected values and ranges.

Precision

Details the precision of the iChemVELOCITY system, including Within Run, Day-To-Day, and Instrument-to-Instrument precision.

Within Run Precision

Shows exact % agreement for analyte concentrations tested multiple times within a single run.

Day-To-Day Precision

Shows exact % agreement for analyte concentrations tested over consecutive days.

Instrument to instrument precision

Shows exact % agreement for analytes tested across multiple iChemVELOCITY systems.

Strip lot to strip lot precision

Shows exact % agreement for analytes tested using different strip lots.

20 Days Specific Gravity Day-to-Day Precision

Presents day-to-day precision data for Specific Gravity over 20 days.

Day 1 - Day 20 Results for color and Clarity

Shows day-to-day precision results for color and clarity measurements over 20 days.

Clinical Concordance Tables

Presents tables showing clinical concordance for various analytes compared to another system.

Ascorbic Acid

Clinical concordance data for Ascorbic Acid.

Bilirubin

Clinical concordance data for Bilirubin.

Blood

Clinical concordance data for Blood.

Glucose

Clinical concordance data for Glucose.

Ketones

Clinical concordance data for Ketones.

Leukocytes

Clinical concordance data for Leukocytes.

Nitrite

Clinical concordance data for Nitrite.

pH

Clinical concordance data for pH.

Protein

Clinical concordance data for Protein.

Urobilinogen

Clinical concordance data for Urobilinogen.

Specific Gravity

Clinical concordance data for Specific Gravity.

Principles of the Tests and Limitations of the Procedure

Explains the principles and limitations of various urine chemistry tests.

Bilirubin

Explains the Bilirubin test principle, expected values, sensitivity, performance, and limitations.

Urobilinogen

Explains the Urobilinogen test principle, expected values, sensitivity, performance, and limitations.

Ketones

Explains the Ketones test principle, expected values, sensitivity, performance, and limitations.

Ascorbic Acid

Explains the Ascorbic Acid test principle, expected values, sensitivity, performance, and limitations.

Glucose

Explains the Glucose test principle, expected values, sensitivity, performance, and limitations.

Protein

Explains the Protein test principle, expected values, sensitivity, performance, and limitations.

Blood

Explains the Blood test principle, expected values, sensitivity, performance, and limitations.

pH

Explains the pH test principle, expected values, performance, and limitations.

Nitrite

Explains the Nitrite test principle, expected values, sensitivity, performance, and limitations.

Leukocytes

Explains the Leukocytes test principle, expected values, sensitivity, performance, and limitations.

Specific Gravity

Notes that Specific Gravity is determined by refractometry, not strip chemistry.

Color and Clarity

Explains that color and clarity are measured using proprietary algorithms.