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LeadCare

II Blood Lead Analyzer

User’s Guide

NOTE:

Instructions for use with Analyzer Firmware Version 1.09

or higher.

Please check the label on the bottom of your

analyzer to determine firmware version.

Summary of Contents for LeadCare II

Page 1: ...LeadCare II Blood Lead Analyzer User s Guide NOTE Instructions for use with Analyzer Firmware Version 1 09 or higher Please check the label on the bottom of your analyzer to determine firmware version...

Page 2: ...UK Tel 44 0 1372 377 754 Fax 44 0 1372 388 282 Copyright 2015 Magellan Diagnostics Inc All rights reserved No part of this publication may be reproduced transmitted transcribed stored in a retrieval...

Page 3: ...ible for a CLIA Certificate of Waiver must follow the manufacturer s instructions as specified in the LeadCare II User s Guide this guide LeadCare II Quick Reference Guide and in the LeadCare II Packa...

Page 4: ...bout the LeadCare II System 1 9 About Blood Lead Testing 1 9 How the LeadCare II System Works 1 10 Intended Use 1 11 Operating Requirements 1 11 Reading the Analyzer Display 1 12 Important Precautions...

Page 5: ...t Controls 3 2 Testing Controls 3 2 Prepare the Sample 3 2 Mix with Treatment Reagent 3 3 Test 3 3 Testing Controls 3 3 Interpreting the Control Test Results 3 5 How Magellan Diagnostics Assigns Lead...

Page 6: ...LeadCare II Blood Lead Testing System Limited Warranty Warranty 6 1 Appendix A Connecting a Compatible Serial Printer Connections A 1 Power On Cycle A 2 Power Off Cycle A 3 Loading Labels A 3 Trouble...

Page 7: ...s 1 8 Figure 1 6 LeadCare II Blood Lead Analyzer 1 9 Figure 1 7 Message Display 1 12 Chapter 2 Calibrating the Analyzer Figure 2 1 Power Switch 2 2 Figure 2 2 Turn Analyzer On 2 2 Chapter 4 Blood Lead...

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Page 9: ...Care II Blood Lead Analyzer Please read the following sections before using the analyzer Unpacking the LeadCare II Blood Lead Analyzer Setting up the Analyzer About the LeadCare II Blood Lead Analyzer...

Page 10: ...fully This symbol indicates the potential for electrostatic discharge Static electricity can damage or destroy the internal components of devices It can be generated by scuffing shoes on a carpet or b...

Page 11: ...the bottom of the instrument indicates that Intertek Electrical Testing Labs ETL has certified the LeadCare II to the applicable safety standards This device complies with Part 15 of the FCC rules Ope...

Page 12: ...rements of Directive 98 79 EC on In Vitro Diagnostic Medical Devices Temperature Limitation Use By Manufacturer Batch Code Biological Risk Caution See Instructions for Use Caution Risk of Electric Sho...

Page 13: ...adCare II materials are contained in two 2 packages 1 LeadCare II Analyzer Kit Analyzer AC Adapter International Power Plug Set 4 AA Alkaline Batteries Quick Reference Guide LeadCare II Flash Drive co...

Page 14: ...t Figure 1 2 Test Kit Contents WARNING Be careful when handling the LeadCare II Treatment Reagent This reagent contains dilute Hydrochloric acid Refer to the LeadCare Treatment Reagent Safety Data She...

Page 15: ...To use the analyzer with a power adapter 1 Plug the DC connector into the back of the analyzer as shown in Figure 1 3 Figure 1 3 Plug in DC Connector AC Adapter 2 Plug the adapter into an AC power ou...

Page 16: ...tab with one or both thumbs and slide it away from the analyzer 5 Insert four 1 5 V AA size alkaline or lithium batteries as shown in Figure 1 5 Figure 1 5 Insert Batteries CAUTION Observe the polarit...

Page 17: ...ing there is no safe level of lead in the blood experts established a new reference value to identify children who have elevated blood lead levels BLL According to the Centers for Disease Control Prev...

Page 18: ...s RBC are lysed which releases the lead that is bound to the RBC wall A negative potential is applied to the sensor to accumulate lead atoms on the test electrode The potential is rapidly reversed rel...

Page 19: ...g Requirements CAUTION Do NOT place the LeadCare II Blood Lead Analyzer in a drafty area For example do NOT place the analyzer near air conditioning or heating vents If the temperature is out of opera...

Page 20: ...play The analyzer monitors the test conditions and displays error messages on the screen if a problem is detected Chapter 5 Troubleshooting and Maintenance includes a list of the messages and what to...

Page 21: ...mple to the treatment reagent within 24 hours of collection Blood older than 24 hours may produce false negative results Make sure the blood sample is free of blood clots which can cause inaccurate re...

Page 22: ...ON When testing controls make sure that the value falls within the acceptable range for each control Do NOT proceed to patient samples if the control results are NOT within acceptable limits Refer to...

Page 23: ...GP44 A4 Procedures for the Handling and Processing of Blood Specimens Approved Guideline 4th ed ISBN 1 56238 724 3 www clsi org CDC Guidelines for Collecting and Handling Blood Lead Samples 2004 Video...

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Page 25: ...About Calibration Calibrating the Analyzer CAUTION Calibration is required for each new lot of test kits Use the calibration button in the test kit Use only the button packaged with the kit you are u...

Page 26: ...0 minutes AC operation it will go into sleep mode Inserting a sensor or moving the power switch to the ON position will restart the analyzer Turn On the Analyzer To turn on the analyzer for the first...

Page 27: ...t the correct level If any one component of the system fails this initial self test the user is warned that the unit requires service and the user is prevented from running any patient samples The fir...

Page 28: ...operly The CALIBRATION SUCCESSFUL message flashes for 2 seconds Calibrating the Analyzer CAUTION Calibration is required for each new lot of test kits Use only the calibration button packaged with the...

Page 29: ...l you hear the beep The button must touch both the center contact and metal side of the button reader There is no need to apply pressure 5 Calibration takes a few seconds When calibration is complete...

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Page 31: ...ated The LeadCare II controls are room temperature stable solutions designed to mimic blood and spiked with lead to specific target values The product is supplied in a two level format Each is assigne...

Page 32: ...ION When testing controls make sure that the value falls within the acceptable range for each control Do NOT proceed to patient samples if the control results are outside acceptable limits Refer to th...

Page 33: ...n the display matches the sensor lot you are using It must also match the lot number on the control vial 3 Invert your sample to ensure the sample is well mixed then remove the cap 4 Using a dropper t...

Page 34: ...t reagent and place it top down on a clean surface Do NOT allow the inside of the cap to touch anything This could cause inaccurate test results 7 Place the capillary tube into the treatment reagent t...

Page 35: ...evel 2 control is outside the acceptable range refer to the troubleshooting section of the LeadCare II User s Guide If after following the instructions the control value is still out of range please c...

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Page 37: ...zer is fast and easy Practice lead testing with the control samples or other samples before you perform a blood lead test The testing procedure consists of the following steps 1 Verify you have the re...

Page 38: ...ad Free Wipes optional Lancets Absorbent Liner and Biohazard Waste Container LeadCare II Analyzer and Power Cord or Batteries LeadCare II Quick Reference Guide LeadCare II User s Guide LeadCare Test K...

Page 39: ...hat appears in Appendix E of this manual for safe handling instructions CAUTION Do NOT use sensors that have been dropped previously handled broken scratched or damaged in any way This could cause ina...

Page 40: ...items are part of the same test kit Do NOT mix components from different test kits Place the following items in front of you in a clean work space Container with heparinized capillary tubes plungers T...

Page 41: ...heparinized capillary tube almost horizontally with the green band on top fill to the 50 L black line Filling stops when the sample reaches the black line Do NOT use plasma or serum Do NOT use venous...

Page 42: ...e 2 Place the full capillary tube in the treatment reagent Insert a plunger into the top of the capillary tube and push down ensuring to dispense the entire volume into the treatment reagent 3 Replace...

Page 43: ...3 Make sure the sensor lot number matches the lot number on the display If the number does not match recalibrate the analyzer and test controls refer to Chapter 3 CAUTION The control lot number must...

Page 44: ...an appropriate biohazard container 11 If you do not remove the sensor after recording your last result within one minute the analyzer will sound two short warning beeps every 15 seconds until the sen...

Page 45: ...g dL When this occurs report the blood lead result as greater than 65 g dL High results on LeadCare II should be followed up immediately as an emergency laboratory test Follow up Testing Blood lead t...

Page 46: ...ference level Report all blood lead test results to the appropriate local state or federal agency Printing Test Results You can print the results by connecting the analyzer to a compatible label print...

Page 47: ...trol Test Results Above the Target Range Possible Causes Screen Display Messages Maintaining the Analyzer Calling LeadCare Product Support If you cannot determine why your system is giving you a probl...

Page 48: ...pplied with the test kit you are using When processing the sample verify the code on the analyzer screen matches the code of the of the sensor lot in use Testing Conditions Operate the analyzer only w...

Page 49: ...lood If there are clots in the blood obtain a new sample Make sure to transfer 50 L of blood into the treatment reagent Wipe the end of the capillary tube with a gauze pad using a downward motion befo...

Page 50: ...ly See detailed precautions below Control Sample Preparation Use the capillary tubes and plungers provided with the test kit to transfer 50 L of control into the treatment reagent tube Always mix the...

Page 51: ...atch the sensor lot and calibration code More than 50 L of control material was transferred to treatment reagent The test sample is warmer than detected by the analyzer The analyzer is not properly ca...

Page 52: ...e control sample or to remove the sample for testing Do NOT touch the black bars on the sensor Do NOT touch the sensor while the analyzer is running a test Make sure the control and treatment reagent...

Page 53: ...SENSOR REMOVED TOO SOON The sensor was removed from the analyzer before the end of the test Remove the sensor Insert a new sensor and add another drop of sample Wait 180 seconds 3 minutes for the tes...

Page 54: ...orded Clean the analyzer with a damp cloth and warm soapy water Do NOT immerse in water Disinfect with dilute 10 bleach solution Do NOT leave any soap film on the analyzer Do NOT allow liquid of any k...

Page 55: ...ion with any such termination and refund you will return the related product to Magellan forthwith upon request This warranty shall apply only to those portions of the software that were developed by...

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Page 57: ...er to generate a label Battery power is insufficient to generate a label The LeadCare II Analyzer has printing capabilities After a result is generated the information is transmitted via a serial conn...

Page 58: ...et Label the adapter so it only gets plugged into the SLP printer 4 Ensure the LeadCare II is plugged into a power outlet with its appropriate adapter Note Battery operation is insufficient to generat...

Page 59: ...a roll of labels on the spindle The LeadCare II utilizes shipping labels 2 1 8 W X 4 L label stock Adjust the guides to fit the labels see below Figure A 4 Label Placement 3 Feed the labels into the...

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Page 61: ...alkaline or lithium batteries 4 each The correct power adapter is included in the analyzer kit DC Input Power External Mode Less than 600 mA DC Input Power Battery Mode Less than 400 mA Battery Life U...

Page 62: ...C to 27 C 59 F to 80 F Whole Blood Sample human EDTA or Heparin are the anticoagulants of choice Store at room temperature RT prior to mixing with Treatment Reagent RT is 10 C to 32 C 50 F to 90 F Sys...

Page 63: ...ophosphamide 500 g mL d Amphetamine Sulfate 100 g mL Diphenylhydramine Hydrochloride 100 g mL Doxorubicin 100 g mL Doxycycline 100 g mL Erythromycin 100 g mL Ferric chloride 100 g mL Ferrous sulfate 1...

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Page 65: ...LeadCare II User s Guide C 1 Appendix C...

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Page 67: ...isease Control CDC CLSI Clinical and Laboratory Standards Institute GP41 A6 Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture Approved Standard Sixth Edition ISBN 1 56238 650...

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Page 69: ...LeadCare II User s Guide E 1 Appendix E Safety Data Sheets MSDS This chapter contains the following LeadCare II Safety Data Sheets LeadCare II Controls LeadCare Treatment Reagent...

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