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Magellan LeadCare Ultra User Manual

Blood lead testing system
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Blood Lead Testing System
User's Guide
WARNING: Read User's Guide before setting up, using, or maintaining this
system. Failure to follow instructions and safety precautions could result in
serious injury, damage or false readings.
Keep User's Guide near system for future reference.

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Summary of Contents for Magellan LeadCare Ultra

  • Page 1 Blood Lead Testing System User’s Guide WARNING: Read User’s Guide before setting up, using, or maintaining this system. Failure to follow instructions and safety precautions could result in serious injury, damage or false readings. Keep User’s Guide near system for future reference.
  • Page 2 Tel: +44 (0) 1372 377 754 Fax: +44 (0) 1372 388 282 Copyright © 2019 Magellan Diagnostics, Inc. All Rights Reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without prior written permission of Magellan Diagnostics, Inc., 101 Billerica Ave, Building 4, N.

  • Page 3: Table Of Contents

    2.6.7 Symbols ......................2-5 System Overview Introduction ........................3-1 About Blood Lead Testing ....................3-1 How the LeadCare Ultra System Works ................. 3-1 System Components ...................... 3-2 3.4.1 Analyzer ......................3-2 3.4.2 Flat Screen Monitor ..................3-3 3.4.3 Computer ...................... 3-3 3.4.4 Barcode Scanner ..................
  • Page 4 6.8.3 Voiding/Unvoiding a Test Result ..............6-14 6.8.4 Editing Test Result Comments ..............6-15 Viewing and Printing Blood Lead Test Results ............. 6-16 6.10 State Reporting of Lead Test Results ................6-19 6.11 Follow-up Testing ......................6-19 LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 5 12 Technical Service Information 12.1 Technical Service Policy ....................12-1 12.2 Preparing for a Technical Service Call ................12-1 13 Returns 14 LeadCare Ultra Blood Lead Testing System Limited Warranty Appendix A Specifications, Specimen and Operating Requirements A.1 Interference Substances ....................A-3 LeadCare Ultra Blood Lead Testing System User’s Guide...
  • Page 6 LeadCare Lead Controls ......................C-1 LeadCare Ultra/Plus Treatment Reagent ................C-1 Figures Chapter 3 Figure 3-1: Major Components of the LeadCare Ultra Blood Testing System ......3-2 Figure 3-2: Test Kit Contents ...................... 3-4 Figure 3-3: LeadCare Ultra UA Software Screen ................ 3-5...
  • Page 7 Appendix B Figure B-1: Back of Analyzer ....................... B-5 Figure B-2: LeadCare Ultra Blood Lead Testing System with Main Log In Screen ...... B-5 Figure B-3: Barcode for Initializing Barcode Scanner ..............B-7 Figure B-4: Calibration Required Dialog Box ................B-8 Figure B-5: Calibration Button .....................
  • Page 8 Table 3-1: Test Kit Contents ...................... 3-4 Table 3-2: Main UA Screen Components ................... 3-6 Table 3-3: LeadCare Ultra Main Screen Major Elements ............3-7 Chapter 7 Table 7-1: Results Below the Target Range or Expected Value ..........7-1 Table 7-2: Results Above the Target Range or Expected Value ..........

  • Page 9: Important Safety Information

    Avoid Injuring Yourself Lab personnel using the LeadCare Ultra Blood Lead Testing System must take steps to avoid contact with blood or treatment reagent. WARNING: Read and follow these safety precautions, and the safety precautions throughout this User’s Guide.

  • Page 10: Avoid Injuring Patients

    Avoid Injuring Patients Patients could suffer injury if the LeadCare Ultra System is used incorrectly and inaccurate blood lead results are reported. CAUTION : Read and follow the safety precautions throughout this User’s Guide. Failure to do so could result in injury from inaccurate test results.

  • Page 11: About This User's Guide

    The LeadCare Ultra Blood Lead Testing System is designed to quantitatively measure the amount of lead in a capillary whole blood sample. The LeadCare Ultra Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use with both the LeadCare Ultra and LeadCare Plus ®...

  • Page 12: User Assistance

    User Assistance Should you experience any difficulty installing or operating your LeadCare Ultra Blood Lead Testing System, please contact your Magellan Diagnostics, Inc. representative. The Troubleshooting chapter in this manual (Chapter 7) includes a list of potential system problems, possible causes, and corrective actions.

  • Page 13: Safety

    2.6.6 Part 11 Compliance The LeadCare Ultra system has been developed to be in compliance with applicable sections of the FDA Electronic Records; Electronic Signatures regulations 21 CFR Part 11. In complying with this regulation, the LeadCare Ultra User Application is designed so that editing of patient results cannot occur.
  • Page 14 User will be provided with the opportunity to enter a new password in a secure manner. The LeadCare Ultra system is intended to be used with LIMS or other third party software for blood lead test result data handling. Magellan Diagnostics' responsibility for compliance with 21 CFR Part 11 compliance ends upon the transfer of results data to the End User's computer network.

  • Page 15: Symbols

    2.6.7 Symbols The following symbols are used in the labeling of the LeadCare Ultra Analyzer and Blood Lead Test Kit. Symbol Description Temperature Limitation Use By Manufacturer Batch Code Biological Risk Caution: See Instructions for Use Consult Instructions for Use...
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  • Page 17: System Overview

    Testing System is designed to quantitatively measure the amount of lead in a capillary whole blood sample. The LeadCare Ultra Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use with both the LeadCare Ultra and LeadCare ®...

  • Page 18: System Components

    System Components The LeadCare Ultra Blood Lead Testing System is a fully integrated, multi-component sytem. A Magellan Diagnostic, Inc. representative will install your system, assist in setting up User accounts, and provide general on-site user training. The LeadCare Ultra Blood Lead Testing System is shipped with the following components (see Figure 3-1).

  • Page 19: Flat Screen Monitor

    3.4.6 Test Kit The LeadCare Ultra Test Kit contains the supplies (treatment reagent, sensors, control material and a calibration button) and instructions for use, required to perform 192 blood lead tests. The complimentary test kit allows the lab to perform validation studies. Figure 3-2 and Table 3-1 illustrate and describe the contents of a test kit.

  • Page 20: Figure 3-2: Test Kit Contents

    Sensors The sensors are single use electrochemical test strips that are inserted into the LeadCare Ultra Analyzer and used for the binding, release and measurement of lead present in a test sample.

  • Page 21: User Application (Ua) Software

    The User Application (UA) software is a Microsoft Windows-based application dedicated to blood lead testing. Figure 3-3 shows the Main UA screen, and Table 3-2 identifies and describes the major software menus and options. Figure 3-3: LeadCare Ultra UA Software Screen LeadCare Ultra Blood Lead Testing System User’s Guide...

  • Page 22: Table 3-2: Main Ua Screen Components

    Table 3-2: Main UA Screen Components Name Description Menu Bar Use the menu bar to access LeadCare Ultra System functions. The top-level menu includes these options: File, View, Tools, and Help. See Table 3-3 for descriptions of all menu functionality.

  • Page 23: Table 3-3: Leadcare Ultra Main Screen Major Elements

    Table 3-3: LeadCare Ultra Main Screen Major Elements Menu Option Description Backup Records Lets you backup test records to a CD/DVD media via a standard Windows dialog box. (see Section 9.1.1) (Admin only) Restore Records Lets you restore (copy) test results stored on a CD/DVD File media via a standard Windows dialog box.

  • Page 24: Printer

    Displays the version numbers of the software and firmware of Help Ultra the analyzer. 3.4.8 Printer A printer can be connected to the LeadCare Ultra System. See Appendix B for instructions. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 25: Calibration And Quality Control Setup

    These steps are required prior to testing. How Calibration Works Each LeadCare Ultra Test Kit comes with one calibration button for the sensors. The calibration button is coded with the data required for the analyzer to translate the raw signal measured on the sensor into the actual lead concentration of blood samples.

  • Page 26: Figure 4-1: The Main "Windows" Login Screen

    1. Power on the computer, monitor, and analyzer. The main “Windows” Login Screen will appear (Figure 4-1). Figure 4-1: The Main “Windows” Login Screen 2. Select your user icon, type in your password, and press Enter. The LeadCare Ultra main screen (Figure 4-2) appears. After 20-30 seconds, the UA initializes the analyzer. LeadCare Ultra Blood Lead Testing System User’s Guide...

  • Page 27: Figure 4-2: Leadcare Ultra Ua Main Screen

    Figure 4-2: LeadCare Ultra UA Main Screen The first time you turn on the analyzer after installation, the “Calibration • NOTES: Required” dialog box appears: Figure 4-3: Calibration Required Screen • Once the system has been calibrated, the lot number of the calibration button is displayed in the upper left corner of the main screen (Sensor Lot #).

  • Page 28: Figure 4-4: Holding Calibration Button To Button Reader

    The Sensor Lot #: appears in the upper left corner of the main screen (see Figure 4-6). Figure 4-6: Sensor Lot # 6. Once the calibration is successful, the “Quality Control Settings” dialog box displays. See Section 4.4, Entering Quality Control Settings, to proceed. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 29: Entering Quality Control Settings

    Target Range: Enter the target value in the first field and the tolerance in the second field. For example, a control with a target value of 7.0 + 3.0 is entered as shown in Figure 4-8. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 30: Figure 4-8: New Qc Lot Dialog Box

    For example, if the target and/or tolerance values are changed, the QC results before and after the change will be on separate QC charts. NOTE: The Target or Tolerance values for a QC lot may be slightly different for other sensor lots. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 31: Figure 4-9: Editing Original Control Lot Target Values

    No. This returns you to the “Quality Control Settings” dialog box to make the necessary corrections. 6. The LeadCare Ultra Blood Lead Testing System is now ready for testing (see Figure 4-12). LeadCare Ultra Blood Lead Testing System User’s Guide...

  • Page 32: Figure 4-11: Confirm Quality Control Level Information Dialog Box

    Figure 4-11: Confirm Quality Control Level Information Dialog Box Figure 4-12: LeadCare Ultra UA Ready for Sensors LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 33: Setting A Patient Test Limit (Optional)

    The Set Patient Test Limit option allows you to flag a patient result that is above a user-specified level. Each laboratory should establish its own limits according to its Standard Operating Procedure (SOP). NOTE: Limits do NOT have to be set to run the LeadCare Ultra Blood Lead Testing System. ► Follow These Steps 1.

  • Page 34: Figure 4-14: Confirm Patient Test Limit Dialog Box

    No. This returns you to the “Patient Test Limits” dialog box to make the necessary corrections. NOTE: If a blood lead result exceeds a limit entered, the typed instructions appear in the Comment field of the sample record on the main screen. LeadCare Ultra Blood Lead Testing System User’s Guide 4-10 ®...

  • Page 35: Performing Quality Control

    CLIA guidelines recommend that a minimum of two levels of QC be performed with each analytical run. Two levels of QC are included in the LeadCare Ultra Test Kit. Each control has an assigned target range (target value +/- tolerance value).

  • Page 36: How Often Should You Test Controls

    • Wear powder-free gloves to prevent lead contamination. Because there is lead in the environment, it is easy to contaminate controls, collection tubes, and test kit items. Contamination of the work environment can cause inaccurate blood lead test results. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 37: Storing And Handling The Controls

    Use this procedure to perform a QC test to help ensure accurate blood lead testing results. The LeadCare Ultra Test Kit is supplied with two levels of QC, each representative of different levels of lead. Level 1 represents a lower lead concentration, while Level 2 represents a higher lead concentration.

  • Page 38: Understanding The Quality Control Results

    Analyze the Sample) on page 6-8. NOTE: Prior to testing, the LeadCare Ultra Level 1 and Level 2 Controls must be mixed with treatment reagent (50 µL of control into a fresh treatment reagent tube). Quality control samples can be prepared and analyzed immediately, or prepared with patient samples.

  • Page 39: Figure 5-1: Quality Control Test View Dialog Box

    4. Enter your search criteria and select the Apply Filter button. 5. Select the View Report button in the lower right corner. 6. The “Custom Report Header Information” screen opens (Figure 5-2). LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 40: Figure 5-2: Custom Report Header Information Screen

    10. The Zoom icon in the menu bar allows you to increase the font size of the report. 11. To print the report, click the Print icon in the menu bar, and then enter the desired print parameters in the standard Windows “Print” dialog box that appears. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 41: Displaying Quality Control Charts

    The chart displayed to the right corresponds to the highlighted chart description. Figure 5-4: Quality Control Charts 4. To view a different chart, click on the chart description in the left column. LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 42 6. The “Order:” feature sorts the charts in ascending or descending order. 7. To print a quality control chart, click the Printer icon above the displayed chart, then enter the desired print parameters in the standard Windows “Print” dialog box that appears. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 43: Performing Blood Lead Testing

    6 Performing Blood Lead Testing Introduction When your LeadCare Ultra ® Blood Lead Testing System has been installed, calibrated, and had QC performed, blood lead tests can be conducted. This chapter describes how to test a patient’s blood for lead. It contains the following topics: •...

  • Page 44: Collection And Storage Conditions

    • Use a calibrated pipet to transfer 50 µL of blood from the collection device into the treatment • reagent tube. Refer to the LeadCare Ultra Test Kit Package Insert for detailed instructions on sample storage • and analysis. NOTE: Allow mixture to reach room temperature before analyzing Extremes in humidity may affect the blood lead results.

  • Page 45: Overview Of The Testing Procedure

    Do NOT use damaged (bent, scratched, cut, etc.) sensors. • Overview of the Testing Procedure Testing for lead in blood with the LeadCare Ultra Blood Lead Testing System consists of the following steps. See Section 6.7 for detailed step-by-step procedures: 1. Make sure you have the required materials.

  • Page 46: General Precautions

    6.5.1 General Precautions Follow these safety precautions any time you are working with the LeadCare Ultra Blood Lead Testing System. WARNINGS: • Dispose of sensors, pipette tips, and other materials exposed to human blood in a biohazard container. • Use caution when handling the LeadCare Ultra Treatment Reagent. The reagent contains dilute HCl.

  • Page 47: Precautions When Testing A Patient Sample

    LeadCare Ultra Blood Lead Test Kit Package Insert. 6.5.3 Precautions when Testing a Patient Sample You must understand and follow these precautions when using the LeadCare Ultra Blood Lead Testing System to test patient blood samples. CAUTION: When testing blood samples: •...

  • Page 48: Required Materials

    80% relative humidity, or in conditions of fluctuating temperature and humidity, may lead to inaccurate results. NOTE: Be sure the LeadCare Ultra Blood Lead Test Kit items all come from the same test kit. Do NOT mix items from different test kits. LeadCare Ultra Blood Lead Testing System User’s Guide...

  • Page 49: Step B: Prepare The Sample

    • Make sure the blood sample is free of blood clots, which can cause inaccurate results. Make sure to dispense exactly 50 µL of blood into the treatment reagent. Please refer to the LeadCare Ultra Test Kit Package Insert for detailed instructions on preparing a sample. ► Follow These Steps 1.

  • Page 50: Step C: Turn The System On

    6.7.3 Step C: Turn the System ON ► Follow These Steps 1. Turn ON the analyzer and login to the LeadCare Ultra System. 2. Check that the calibration code of the sensors in use matches the calibration code displayed on the main screen.

  • Page 51: Figure 6-2: Ua Waiting For Barcodes

    NOTE: Barcode Scanner Not Connected – The barcode scanner does not need to be connected to the system in order to use the LeadCare Ultra UA. The UA defaults to manual entry mode when the barcode scanner is not connected. Specifically, if the scanner is not connected when the UA starts, the “BAR CODE READER FAILED”...

  • Page 52: Figure 6-3: Ua Waiting For Samples

    Figure 6-4: UA Analyzing Samples 7. The system shows a graphic of the analysis countdown as analysis proceeds, from 180 seconds to 0 seconds. Figure 6-5: UA Analysis Complete LeadCare Ultra Blood Lead Testing System User’s Guide 6-10 ®...

  • Page 53: Processing Blood Lead Test Results

    Results are reported in micrograms (µg) of lead (Pb) per deciliter (dL) of whole human blood. Results are displayed to one decimal place. The reportable range of the LeadCare Ultra is 1.9 µg/dL to 65.0 µg/dL. Results lower than the limit of detection will be displayed as ‘<1.9’.

  • Page 54: Archiving Test Results

    6.8.1 Archiving Test Results Results in the main data table can be archived; whereby they will remain on the LeadCare Ultra Blood Lead Testing System indefinitely. If your LeadCare Ultra Blood Lead Testing System is NOT connected to an LIS, follow steps 1 and 2 to archive your results.

  • Page 55: Approving Test Results

    Test results can be approved either from the main data table (worklist) or from the “Archived Test View”. If your LeadCare Ultra System is connected to an LIS, use the following steps, steps 1-3, to approve your test results and to make the results available for access by the LIS.

  • Page 56: Voiding/Unvoiding A Test Result

    To unvoid a voided test result (Admins and/or User Accessible), right-click on the voided Sample ID you wish to unvoid in the main data table, then select Unvoid Test from the pop-up (Figure 6-10). Figure 6-10: Unvoid Test Pop-Up Menu LeadCare Ultra Blood Lead Testing System User’s Guide 6-14...

  • Page 57: Editing Test Result Comments

    Edit Comments from the pop-up menu shown in Figure 6-11. Click in the “Edit Test Comments” box and type in your new comments as desired. Click OK to accept. Figure 6-11: Edit Test Comments Box NOTE: “Edit Test Comments” is also available for QC results. LeadCare Ultra Blood Lead Testing System User’s Guide 6-15 ®...

  • Page 58: Viewing And Printing Blood Lead Test Results

    Filter tests by specified values 3. If you selected “Filter records by specified values”, you can further refine your search by: a. Sample ID b. Test Date range c. Result range LeadCare Ultra Blood Lead Testing System User’s Guide 6-16 ®...

  • Page 59: Figure 6-13: Custom Report Header Information Screen

    6. Enter the desired report header on line 1 and then click Done. (Lines 2 and 3 are provided for multi-part headers). The specified report is displayed. A sample Archived Test Report is shown in Figure 6-14. LeadCare Ultra Blood Lead Testing System User’s Guide 6-17...

  • Page 60: Figure 6-14: Archived Test Report

    9. To print the report, click the Print icon in the menu bar, and then enter the desired print parameters in the standard Windows “Print” dialog box that appears. LeadCare Ultra Blood Lead Testing System User’s Guide 6-18 ®...

  • Page 61: State Reporting Of Lead Test Results

    NOTE: Report all blood lead test results to the appropriate local, state, or federal agency. Additional questions can be directed to Magellan Diagnostics Product Support at 800-275-0102 or LeadCareSupport@magellandx.com. 6.11 Follow-up Testing According to the US Centers for Disease Control (CDC), there is no known safe level of lead. Consult your local public health department and/or CDC recommendations for information on the management of blood lead levels.
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  • Page 63: Troubleshooting

    • When processing controls, check to make sure the sensor lot number on the main screen matches the lot number of the calibration button for the test kit. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 64: Table 7-2: Results Above The Target Range Or Expected Value

    Problem Area Check the Following Testing Conditions • Avoid operating the LeadCare Ultra System in drafts or outside the specified temperature range 16°C - 30°C (61°F - 86°F) and specified humidity range (12 - 80%, Relative Humidity). • Make sure that the system and the test kit are maintained at a constant temperature.
  • Page 65 Testing Conditions • Avoid operating the LeadCare Ultra System in drafts or outside the specified temperature range (16°C - 30°C / 61°F - 86°F) and specified humidity range (12 - 80%, Relative Humidity).

  • Page 66: Summary Of Display Messages

    ON position. by the USB cable. • Confirm that the analyzer is connected to the computer via the USB cable. LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 67 • Remove sensor, turn channel failed. analyzer OFF, then turn analyzer ON. Wait ~10 seconds for the UA to initialize the analyzer. Insert a new sensor. • If the error continues, call Product Support. LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 68 • Attempt to re-calibrate calibrate. using the calibration button. o Button did not make sufficient contact in • If the error continues, button reader port call Magellan Product Support. o Defective calibration button LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 69 • The ambient • Move the analyzer temperature around away from drafty the analyzer changed area. Allow the analyzer to adjust to too much to perform the test. the ambient temperature. LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 70 Magellan Product Support. Sensor(s) Inserted on Exit • One or more sensors • Remove and discard were detected in the sensors. analyzer as the analyzer was turned OFF. LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 71 • Remove and discard was put on the sensor sensor. to start the test. • Confirm pipette delivers at least 30 µL. • Repeat test, verifying sample fills the channel on the sensor. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 72: Calling Magellan Diagnostics Product Support

    Magellan Product Support. Calling Magellan Diagnostics Product Support After troubleshooting, if you are unable to resolve your issue, contact Magellan Diagnostics Product Support at 800-275-0102 or LeadCareSupport@magallendx.com. Please write down this information and have it ready before you call: Serial Number of Analyzer (on bottom of Analyzer and under Help >...

  • Page 73: Performing Other Tasks

    8 Performing Other Tasks This section describes how to perform a number of common tasks on the LeadCare Ultra UA. These ® tasks can be performed by the system administrator or an operator. Viewing Calibration History The Calibration History option displays a dialog box in which you enter search criteria to search for and display calibration records.

  • Page 74: Figure 8-2: Custom Report Header Information Screen

    Binoculars icon in the menu bar to search the results for a specific calibration record. 7. To print the report, click the Print icon in the menu bar, and then enter the desired print parameters in the standard Windows “Print” dialog box that appears. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 75: Viewing Error History

    • Figure 8-4: Error History View Dialog Box 2. Use the mouse to select one of the following search (filter) criteria: a. Show all records b. Filter records by specified values LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 76: Figure 8-5: Custom Report Header Information Screen

    If entering the report for troubleshooting purposes, please enter: Line 1: Organization name Line 2: Problem description 8. The specified report is displayed. A sample Error History Report is shown in Figure 8-6. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 77: Viewing User Login History

    1. To display user login records, click View > User Login History. The “User Login History” dialog box displays (Figure 8-7), showing user login records identified by User Name, User Type, Logged In On, and Logged Out On. LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 78: Figure 8-7: User Login History Dialog Box

    User Name and User Type. Enter your search criteria and click the View Report button. The Custom Report Header Information screen displays (Figure 8-8). Figure 8-8: Custom Report Header Information Screen LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 79: Creating User Accounts

    The Laboratory Manager or another laboratory designee with “Account Manager” privileges may assign or delete accounts, as well as change user passwords for the LeadCare Ultra software. If you are setting up the LeadCare Ultra System without the help of a Magellan Diagnostic Representative, or if you want to add or change User Accounts, please follow the steps below.

  • Page 80: Figure 8-10: Main Login Screen

    Figure 8-10: Main Login Screen 2. Select the Account Manager User icon, type in the password, and press Enter. The LeadCare Ultra User Account Manager dialogue box appears, containing a chart with User Name, User Type, and Description fields (see Figure 8-11).

  • Page 81: Figure 8-11: Account Manager Dialog Box

    Figure 8-11: Account Manager Dialog Box NOTE: The LeadCare Ultra User Account Manager has five pre-defined Administrator fields and fifteen pre-defined Operator fields. 3. Select an appropriate New User, either an Operator or an Administrator. When the field is selected it will be highlighted and the “Assign User” field will become active.

  • Page 82: Lis Interface

    Connectivity to LIS. NOTE: Refer to the Connectivity to LIS document for LeadCare Ultra which describes how data is transmitted between the Ultra application and an external system such as LIS. If you need this document, please contact Product Support.

  • Page 83: Figure 8-13: Lis Interface Status

    To View the status of the connection in the Ultra User App select Tools > LIS > Status. The LIS Interface Status box will open and display (Figure 8-13): Current status of the connection between the Ultra and the LIS. • IP Address assigned to the LeadCare Ultra computer. • • TCP Port.
  • Page 84 The queue contents can be cleared by clicking the Clear Queue button (Admin only). The LIS Interface Status box can be closed by clicking OK button. LeadCare Ultra Blood Lead Testing System User’s Guide 8-12 ®...

  • Page 85: Maintaining Test Results

    Back-up data to writeable CD/DVD type media. • • Restore previously backed up data from a CD/DVD type media onto the LeadCare Ultra UA. These features are only available to Users with Administrator access credentials. They can be accessed by selecting: •...

  • Page 86: Restoring Blood Lead Sample Test Results

    A Simple Restore – Restoring data onto a blank/empty LeadCare Ultra system. • A Merge Restore – Restoring data onto a LeadCare Ultra system already containing data. • The Restore process places previously backed-up information, onto the LeadCare Ultra System: •...

  • Page 87: Figure 9-3: Confirm Restore Operation Dialog Box

    The Restore function can be accessed by selecting Tools > Restore. The “Confirm Restore Operation” dialog box (Figure 9-3) will appear on the screen to guide the user through the Restore process: Figure 9-3: Confirm Restore Operation Dialog Box LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 88: Figure 9-4: Restore Successful Dialog Box

    Upon completion of the Restore process, the following notification will appear on the screen and the CD/DVD will be automatically ejected: Figure 9-4: Restore Successful Dialog Box LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 89: Maintenance

    NOTE: Maintenance activities relating to the analyzer do NOT require the analyzer enclosure to be opened. There are no user serviceable parts inside the LeadCare Ultra Analyzer. 10.1 Cleaning Procedures 10.1.1 Cleaning the Analyzer The exterior case of the analyzer can be cleaned using a lint-free cloth dampened with a 10% bleach solution.

  • Page 90: Cleaning Other System Components

    It is best to use a cotton swab to massage the bleach solution between the keys of the • keyboard. 10.1.4 Cleaning Other System Components Follow the manufacturer’s instructions to clean the exterior surfaces of the computer screen and mouse. LeadCare Ultra Blood Lead Testing System User’s Guide 10-2 ®...

  • Page 91: Reordering Information

    11 Reordering Information Ordering replacement parts for your LeadCare Ultra Blood Lead Testing System is simple. If you know ® the item number, please contact our Customer Service Department at 800-959-5095 to complete your order. If you are unsure of the item number, or for a complete list of parts, please visit https://www.magellandx.com/leadcare-products/leadcare-ultra/support/parts-service/.
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  • Page 93: Technical Service Information

    Before you make a technical service call, be sure to obtain the following information, as appropriate, to submit with your request or question: System version number. In the UA, select Help > About LeadCare Ultra, to display this • information.
  • Page 94 Do not use yellow pad paper or a pencil because the fax may not be legible when we receive it. • If you are reporting a problem that you have experienced before, please have your case number available. Product Support 800-275-0102 LeadCareSupport@magellandx.com LeadCare Ultra Blood Lead Testing System User’s Guide 12-2 ®...

  • Page 95: Returns

    2. After such warranty period, any labor, transportation, and subsistence expense shall be borne by the Buyer. If preferred, Buyer may return goods to Magellan Diagnostics with shipment both ways at Buyer’s expense for repair work.
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  • Page 97: Leadcare Ultra Blood Lead Testing System Limited Warranty

    IMPORTANT – READ CAREFULLY THE FOLLOWING TERMS AND CONDITIONS. BY INSTALLING AND USING THE SOFTWARE, YOU ARE AGREEING TO BE BOUND BY THE TERMS OF THIS AGREEMENT: Magellan Diagnostics, Inc. (“Seller”) hereby sells the LeadCare Ultra Blood Lead Testing System (the “System”) ®...
  • Page 98 INCIDENTAL OR CONSEQUENTIAL DAMAGES SO THIS LIMITATION MAY NOT APPLY TO CERTAIN BUYERS. IN NO EVENT SHALL SELLER’S TOTAL LIABILITY TO BUYER FOR ALL DAMAGES EXCEED THE AMOUNT BUYER HAS PAID SELLER OR ITS AUTHORIZED DISTRIBUTOR. Copyright © 2015 Magellan Diagnostics, Inc. LeadCare Ultra Blood Lead Testing System User’s Guide 14-2 ®...

  • Page 99: Appendix A Specifications, Specimen And Operating Requirements

    Appendix A Specifications, Specimen and Operating Requirements This chapter provides specifications for the LeadCare Ultra Blood Lead Testing System. ® Table A-1: LeadCare Ultra System Specifications Overview System Description 6-channel, electrochemical blood lead analyzer Throughput Up to 90 tests per hour Analysis Time 3 min.
  • Page 100 16°C - 30°C (61°F - 86°F ) Relative Humidity 12% - 80% Relative Humidity (non-condensing) Altitude LeadCare Ultra System can be operated in altitudes up to 8,000 feet (2,440 meters) above sea level. Storage Ranges Analyzer 15°C - 30°C (59°F - 86°F )

  • Page 101: Interference Substances

    Lead results for samples with each potential interference did not differ statistically from lead results obtained on unadulterated samples. The following substances at the following concentrations do NOT affect the results of the LeadCare Ultra Blood Lead Testing System: Hydroxyurea, 250 µg/mL...
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  • Page 103 LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 104 LeadCare Ultra Blood Lead Testing System User’s Guide ®...

  • Page 105: Appendix B Setup Guide

    The system requires two (2) grounded electrical outlets. • Set up the LeadCare Ultra Blood Lead Testing system in an area that is free of drafts and • temperature extremes. For best results, the analyzer needs to operate in a stable temperature environment: o 16°C - 30°C (61°F - 86°F)

  • Page 106: Table B-1: Analyzer Kit Box Contents

     • Serial/USB cable (Grey)  NOTE: The following items included in the LeadCare Ultra boxes, are NOT necessary for setup: Cable cover for monitor, silver monitor stand, and display port • cable. (All found in Monitor box.) Computer cable cover. (Found in AIO box.) •...

  • Page 107: Manufacturer's Instruction For Setup

    During setup please make note of model numbers and serial numbers on the Installation Checklist found in the Validation Booklet provided by Magellan Diagnostics. Set Up AIO Stand and Connect the Monitor Refer to the instructions provided in the monitor box. Place the AIO stand on a stable, level surface.

  • Page 108: Registering Your System

    LeadCare Ultra Blood Lead Testing System. B.4 Preparing for Operation At this point, you have set up and installed the LeadCare Ultra Blood Lead Testing System successfully as a stand-alone device. Follow the procedures outlined below to confirm the system is operational and prepare for daily use: a.

  • Page 109: Figure B-1: Back Of Analyzer

    Figure B-2: LeadCare Ultra Blood Lead Testing System with Main Log In Screen In order to use the LeadCare Ultra Blood Lead Testing System software you must establish a User Account. The Laboratory Manager or another laboratory designee with “Account Manager” privileges may assign or delete accounts, as well as change User passwords for the LeadCare Ultra software.
  • Page 110 If you are setting up the LeadCare Ultra System without the help of a Magellan Diagnostic Representative, or if you want to add or change User accounts, please follow the steps below. These steps can also be found in the chapter entitled Performing Other Tasks in the User’s Guide.

  • Page 111: Figure B-3: Barcode For Initializing Barcode Scanner

    Initialize the Barcode Scanner If you installed your LeadCare Ultra System on your own, or if the barcode scanner was not initialized by the Magellan Diagnostic Representative, you must scan the barcode below to initialize the scanner before use. (Figure B-3) Figure B-3: Barcode for Initializing Barcode Scanner The scanner makes three rapid beeps.

  • Page 112: Figure B-4: Calibration Required Dialog Box

    Log in to proceed. What is Calibration? Each LeadCare Ultra Test Kit comes with a specific calibration button coded for the sensors provided for that sensor lot #. The calibration button is coded with the data required for the analyzer to translate the raw signal measured on the sensor into the actual lead concentration of blood samples.

  • Page 113: Figure B-5: Calibration Button

    3. Calibration takes a few seconds. When calibration is complete, the analyzer beeps and the screen briefly shows a message stating that the analyzer was calibrated successfully. (Figure B-7). Figure B-7: Successful Calibration Message LeadCare Ultra Blood Lead Testing System User’s Guide ®...
  • Page 114 4. Connect the printer’s USB cable to the LeadCare Ultra Computer when requested. 5. Say NO to any add-on features and NO to updates. 6. When prompted, say YES to sharing. (If you don’t check off sharing, LeadCare Ultra operators will not have access to the printer.) 7.
  • Page 115 4. Select Sharing Tab 5. Click Share Printer The installation and set-up of your LeadCare Ultra Blood Lead Testing System is now complete. Please read the information detailed in the User’s Guide prior to performing testing. If you have any questions, contact Magellan Diagnostics Product Support at 800-275-0102 Monday through Friday between 8 AM and 6 PM (EST) or by email at LeadCareSupport@magellandx.com.
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  • Page 117: Appendix C Safety Data Sheets (Msds)

    Appendix C Safety Data Sheets (SDS) This chapter contains the following LeadCare ® Ultra Safety Data Sheets: LeadCare Ultra/Plus Controls • • LeadCare Ultra/Plus Treatment Reagent LeadCare Ultra Blood Lead Testing System User’s Guide ®...
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