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Magellan LeadCare Ultra Manuals
Manuals and User Guides for Magellan LeadCare Ultra. We have
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Magellan LeadCare Ultra manual available for free PDF download: User Manual
Magellan LeadCare Ultra User Manual (118 pages)
Blood Lead Testing System
Brand:
Magellan
| Category:
Diagnostic Equipment
| Size: 8.01 MB
Table of Contents
Table of Contents
3
Important Safety Information
9
Avoid Injuring Yourself
9
Avoid Injuring Patients
10
Avoid Damaging the System
10
Avoid Losing Blood Lead Test Result Files
10
Biohazard Warnings
10
About this User's Guide
11
Intended Use
11
Clinical Laboratory Improvement Amendments (CLIA) Classification
11
Additional Documentation
11
User Assistance
12
Acronyms
12
Compliance Statements
12
CE Mark
12
EMC Directive
12
Safety
13
Fcc
13
Waste Electrical and Electronic Equipment
13
Part 11 Compliance
13
Symbols
15
System Overview
17
Introduction
17
About Blood Lead Testing
17
How the Leadcare Ultra System Works
17
System Components
18
Analyzer
18
Chapter 3
18
Figure 3-1: Major Components of the Leadcare Ultra Blood Testing System
18
Flat Screen Monitor
19
Computer
19
Barcode Scanner
19
Keyboard
19
Test Kit
19
Figure 3-2: Test Kit Contents
20
Table 3-1: Test Kit Contents
20
User Application (UA) Software
21
Figure 3-3: Leadcare Ultra UA Software Screen
21
Table 3-2: Main UA Screen Components
22
Table 3-3: Leadcare Ultra Main Screen Major Elements
23
Printer
24
Calibration and Quality Control Setup
25
Introduction
25
How Calibration Works
25
Calibration Procedure
25
Chapter 4
26
Figure 4-1: the Main "Windows" Login Screen
26
Figure 4-2: Leadcare Ultra UA Main Screen
27
Figure 4-3: Calibration Required Screen
27
Figure 4-4: Holding Calibration Button to Button Reader
28
Figure 4-5: Successful Calibration Message
28
Figure 4-6: Sensor Lot
28
Entering Quality Control Settings
29
Figure 4-7: New QC Lot Dialog Box
29
Figure 4-8: New QC Lot Dialog Box
30
Figure 4-10: Entering New Target Values
31
Figure 4-9: Editing Original Control Lot Target Values
31
Figure 4-11: Confirm Quality Control Level Information Dialog Box
32
Figure 4-12: Leadcare Ultra UA Ready for Sensors
32
Figure 4-13: Patient Test Limits Dialog Box
33
Setting a Patient Test Limit (Optional)
33
Figure 4-14: Confirm Patient Test Limit Dialog Box
34
Performing Quality Control
35
Introduction
35
What Are Blood Lead Controls
35
How Often Should You Test Controls
36
Safety Precautions
36
Storing and Handling the Controls
37
Control Procedure
37
Understanding the Quality Control Results
38
Viewing Quality Control Test Records
38
Chapter 5
39
Figure 5-1: Quality Control Test View Dialog Box
39
Figure 5-2: Custom Report Header Information Screen
40
Figure 5-3: Sample Quality Control Test Report
40
Displaying Quality Control Charts
41
Figure 5-4: Quality Control Charts
41
Performing Blood Lead Testing
43
Introduction
43
Specimen Requirements
43
Acceptable Anticoagulants and Collection Devices
43
Collection and Storage Conditions
44
Limitations of the Test
44
Overview of the Testing Procedure
45
Safety Precautions
45
General Precautions
46
Precautions When Preparing Patient Samples
46
Precautions When Testing a Patient Sample
47
Required Materials
48
Testing Procedure
48
Step A: Gather Test Materials
48
Step B: Prepare the Sample
49
Step C: Turn the System on
50
Step D: Analyze the Sample
50
Chapter 6
50
Figure 6-1: UA Ready to Accept Sensors
50
Figure 6-2: UA Waiting for Barcodes
51
Figure 6-3: UA Waiting for Samples
52
Figure 6-4: UA Analyzing Samples
52
Figure 6-5: UA Analysis Complete
52
Processing Blood Lead Test Results
53
Archiving Test Results
54
Figure 6-6: Approve & Archive Pop-Up Menu
54
Approving Test Results
55
Figure 6-7: Archive Tests Dialog Box
55
Figure 6-8: Approve Tests Dialog Box
55
Voiding/Unvoiding a Test Result
56
Figure 6-9: Void Test Pop-Up Menu
56
Figure 6-10: Unvoid Test Pop-Up Menu
56
Editing Test Result Comments
57
Figure 6-11: Edit Test Comments Box
57
Figure 6-12: Archived Test View Dialog Box
58
Viewing and Printing Blood Lead Test Results
58
Figure 6-13: Custom Report Header Information Screen
59
Figure 6-14: Archived Test Report
60
Follow-Up Testing
61
State Reporting of Lead Test Results
61
Troubleshooting
63
Introduction
63
Chapter 7
63
Table 7-1: Results below the Target Range or Expected Value
63
Table 7-2: Results above the Target Range or Expected Value
64
Summary of Display Messages
66
Table 7-3: UA Error Messages
66
Calling Magellan Diagnostics Product Support
72
Chapter 8
73
Figure 8-1: Calibration History Dialog Box
73
Figure 8-2: Custom Report Header Information Screen
74
Figure 8-3: Sample Calibration History Report
74
Figure 8-4: Error History View Dialog Box
75
Viewing Error History
75
Figure 8-5: Custom Report Header Information Screen
76
Figure 8-6: Sample Error History Report
77
Viewing User Login History
77
Figure 8-7: User Login History Dialog Box
78
Figure 8-8: Custom Report Header Information Screen
78
Creating User Accounts
79
Figure 8-9: Sample User Login History Report
79
Figure 8-10: Main Login Screen
80
Figure 8-11: Account Manager Dialog Box
81
Figure 8-12: LIS Configuration
82
LIS Interface
82
Figure 8-13: LIS Interface Status
83
Performing Other Tasks
73
Viewing Calibration History
73
Maintaining Test Results
85
Backing up Blood Lead Sample Test Results
85
Restoring Blood Lead Sample Test Results
86
Chapter 9
86
Figure 9-1: Confirm Backup Operation Dialog Box
86
Figure 9-2: Backup Successful Dialog Box
86
Figure 9-3: Confirm Restore Operation Dialog Box
87
Table 9-1: Examples of Maintaining Updated Information During Merge Restore
87
Figure 9-4: Restore Successful Dialog Box
88
Maintenance
89
Cleaning Procedures
89
Cleaning the Analyzer
89
Cleaning the Barcode Scanner
89
Cleaning the Keyboard
89
Cleaning Other System Components
90
Reordering Information
91
Technical Service Information
93
Technical Service Policy
93
Preparing for a Technical Service Call
93
Returns
95
Leadcare Ultra Blood Lead Testing System Limited Warranty
97
Appendix A Specifications, Specimen and Operating Requirements
99
Table A-1: Leadcare Ultra System Specifications
99
Interference Substances
101
Appendix B Setup Guide
105
Establishing the Work Area
105
Setting up the Analyzer and Computer Components
105
Unpacking the System
105
Table B-1: Analyzer Kit Box Contents
106
Table B-2: Computer System Kit Contents
106
Manufacturer's Instruction for Setup
107
Registering Your System
108
Preparing for Operation
108
Figure B-1: Back of Analyzer
109
Figure B-2: Leadcare Ultra Blood Lead Testing System with Main Log in Screen
109
Figure B-3: Barcode for Initializing Barcode Scanner
111
Figure B-4: Calibration Required Dialog Box
112
Figure B-5: Calibration Button
113
Figure B-6: Holding Calibration Button to Button Reader
113
Figure B-7: Successful Calibration Message
113
Appendix C Safety Data Sheets (MSDS)
117
Leadcare Ultra/Plus Treatment Reagent
117
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