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General| Brand | Magellan |
|---|---|
| Model | LeadCare II |
| Category | Measuring Instruments |
| Language | English |
Lists supporting documents such as Quick Reference Guide, Test Kit Package Insert, and Flash Drive for additional product information.
Directs users to Chapter 5 for detailed troubleshooting procedures and provides essential contact information for support.
Explains symbols like WARNING, CAUTION, NOTE, and biohazard, crucial for understanding safety and procedures.
Details regulatory compliance (CE Mark, EMC, Safety) and FCC rules applicable to the device.
Provides a comprehensive list and description of all symbols used in labeling the analyzer and test kit.
Details the contents of the two primary packages that comprise the complete LeadCare II system.
Guides users to register their analyzer online to receive important updates and information from Magellan Diagnostics.
Covers essential setup steps, including work area, power adapter usage, and initial power-on procedures.
Provides step-by-step instructions and crucial safety precautions for installing AA batteries into the analyzer.
Offers a brief overview of the LeadCare II analyzer, highlighting its function as a portable blood lead testing device.
Discusses childhood lead poisoning and the CDC's established reference value for blood lead levels (BLLs).
Explains the electrochemical technique (Anodic Stripping Voltammetry) used by the system to determine lead levels.
Specifies the analyzer's purpose for in vitro blood lead testing and its designation for professional use only.
Details environmental and operational conditions necessary for accurate analyzer performance, including temperature alerts.
Guides users on interpreting various messages displayed on the analyzer screen during the testing process.
Highlights critical safety and procedural information necessary for the safe and effective use of the analyzer.
Outlines essential precautions for sample collection and preparation to ensure accurate and reliable test results.
Covers specific safety measures and handling procedures required when performing tests on patient blood samples.
Details necessary precautions to ensure the accuracy and reliability of quality control tests for system verification.
Explains how to properly use and handle control materials to ensure the accuracy and quality of test results.
Provides references to external resources for additional information on blood sample collection and lead testing.
Lists key resources and guidelines from CLSI and CDC for proper blood sample collection techniques.
Directs users to the CDC website for the most current and up-to-date information regarding blood lead testing.
Points users to the Magellan Diagnostics website for further details and resources related to the LeadCare II product.
Provides contact details for Product Support specialists, including phone numbers and email addresses for assistance.
Explains how to operate the power switch and the analyzer's automatic sleep mode functionality.
Describes the automatic self-tests performed by the analyzer upon startup and their purpose in ensuring proper operation.
Explains the importance of calibrating the analyzer and outlines the specific conditions requiring recalibration.
Provides step-by-step instructions and important cautions for calibrating the analyzer using the provided calibration button.
Defines what a control is and explains its role in evaluating test results for system accuracy and performance.
Details the proper storage conditions, handling precautions, and expiration date considerations for control materials.
Outlines the frequency and specific conditions under which quality control tests should be performed according to guidelines.
Provides a comprehensive step-by-step guide on how to perform quality control tests using Level 1 and Level 2 controls.
Explains how to interpret control test results against acceptable ranges and what actions to take if deviations occur.
Briefly explains the methodology Magellan Diagnostics uses to establish acceptable ranges for control materials.
Provides a general overview of the blood lead testing process, emphasizing practice with control samples for proficiency.
Explains the function of the message display screen in guiding users through the testing process and displaying results.
Lists all necessary materials and components required for performing a blood lead test accurately and safely.
Highlights critical precautions to follow during blood lead testing to ensure accurate results and prevent contamination.
Details the complete step-by-step procedure for conducting a blood lead test on a patient sample.
Guides users on how to read and interpret the blood lead results displayed by the analyzer, including 'Low' and 'High' values.
Advises on sharing results with physicians, retesting protocols, and follow-up actions based on blood lead test outcomes.
Explains how to print test results by connecting the analyzer to a compatible label printer via Appendix A.
Lists external sources and websites for additional information on lead poisoning and blood lead testing guidelines.
Provides instructions and lists essential information required when contacting Product Support for technical assistance.
Identifies possible causes and provides solutions for blood lead test results that fall below target or expected values.
Identifies possible causes and provides solutions for blood lead test results that exceed target or expected values.
Lists potential reasons for control test results falling below the acceptable range, aiding in quality control troubleshooting.
Lists potential reasons for control test results exceeding the acceptable range, aiding in quality control troubleshooting.
Explains common messages displayed on the analyzer screen and the recommended actions to resolve issues.
Provides essential instructions for cleaning and routine maintenance of the LeadCare II analyzer to ensure longevity.
Details the terms and conditions of the limited warranty provided by Magellan for the LeadCare II system and software.
Describes the physical serial cable connections required to link the analyzer to a compatible label printer.
Outlines the sequential steps for powering on the printer and analyzer to successfully generate a label.
Provides clear instructions for properly powering down both the analyzer and the connected printer.
Guides users on the correct procedure for loading label rolls into the printer for subsequent label generation.
Offers essential troubleshooting tips for common printer issues like label jams, voltage errors, or offline status.
Lists the physical, electrical, and other technical specifications pertinent to the LeadCare II analyzer.
Details the crucial storage ranges and system operating ranges for temperature, humidity, and altitude.
Lists substances that do not affect the accuracy of LeadCare II System results at specified concentrations.
Provides guidelines for repeat and diagnostic blood lead testing for pediatric patients based on age and previous results.
Lists key references providing additional information and detailed guidance on blood sample collection methods for lead testing.
Refers to the specific safety data sheet (SDS) for LeadCare II Controls, detailing handling and safety information.
Refers to the specific safety data sheet (SDS) for LeadCare Treatment Reagent, detailing handling and safety information.
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