80-0062-00-MO-RevH 2018-5-8 SunTech Oscar 2 User Manual | 3
Contents
Changes ................................................................................. 2
Copyright Information ......................................................... 2
Contents ................................................................................. 3
1. Introduction to Ambulatory Blood Pressure Monitoring ...
4
2. Introduction to Central Blood Pressure Monitoring ........ 4
3. Symbols Used in Labeling................................................. 5
4. The Oscar 2 ABPM System .............................................. 6
Indications for Use ............................................................... 6
Device Operation .................................................................. 6
Products and Accessories .................................................. 7
About AccuWin Pro™ 4 ........................................................ 8
A Note About HIPAA ............................................................ 8
Biocompatibility and Applied Parts ................................... 8
Specifications ........................................................................ 8
Safety and Effectiveness Considerations ..................... 10
Disposal ................................................................................ 10
Potential Adverse Reactions ........................................... 10
Cautions for Use ................................................................. 11
Warnings .............................................................................. 11
Cautions ............................................................................... 12
Contraindications ............................................................. 13
5. Setting Up The Oscar 2 System ..................................... 15
Installing AccuWin Pro™ 4 ................................................ 16
Communicating with the Oscar 2.................................... 17
Wireless Communications ............................................... 17
True24 Mobile Application ................................................ 17
Logging in to AccuWin Pro™ 4 ......................................... 18
Changing Your Password ................................................. 18
Changing the Current User ............................................... 19
6. AccuWin Pro™ 4 Layout .................................................. 19
Toolbar Buttons .................................................................. 19
7. Conducting an Ambulatory Blood Pressure Study ....... 20
Programming the Oscar 2 for an ABP Study ................ 20
Parameter Settings ............................................................ 23
Fitting a Patient with the Oscar 2 and SunTech ABPM
Cuff........................................................................................ 25
Preparing and Educating The Patient ............................. 26
Starting the Study ............................................................... 26
Finishing the Study ............................................................. 27
8. Notes on Blood Pressure Data ....................................... 27
Retrieving Data from the ABP Monitor ........................... 28
9. Reviewing and Editing an ABP Study ............................. 28
Opening A Patient File ....................................................... 28
Viewing an Ambulatory Blood Pressure Study ............. 29
Reviewing an Ambulatory Blood Pressure Study ......... 31
Entering Comments ........................................................... 32
Setting BP Threshold Limits ............................................. 33
Setting Pediatric Threshold Limits .................................. 34
Defining Time-Slice Periods ............................................. 34
Editing Patient Info and Physician Info .......................... 35
Viewing Dose Response Statistics ................................. 38
Viewing Time-Slice Statistics .......................................... 39
Viewing Hourly Averages.................................................. 39
Viewing the Interpretive Report Summary .................... 40
Comparing Two Studies ................................................... 41
10. Creating Reports ............................................................ 41
Configuring and Customizing the Report ...................... 41
Previewing the Report ....................................................... 43
Printing the Report ............................................................. 44
Saving the Report as a PDF ............................................. 44
11. Overview of AccuWin™ Pro 4 Report Symbols ............ 44
12. Managing Patient Studies ............................................. 45
Opening a Patient Study ................................................... 45
Exporting a Patient Study ................................................. 45
Emailing a Patient Study................................................... 46
Deleting a Patient Record ................................................. 46
Importing a Patient Record .............................................. 46
Grouping Patient Records ................................................ 46
13. Customizing and Configuring AccuWin Pro™ 4 .......... 47
Hardware Settings ............................................................. 48
Data Settings ...................................................................... 48
Display Settings .................................................................. 49
Diary Comment Settings .................................................. 49
Email Settings ..................................................................... 50
Report Settings ................................................................... 50
Export Settings ................................................................... 51
14. Overview of Event Codes .............................................. 51
Event Code Definitions ...................................................... 51
15. Administrative Tools ..................................................... 53
Specifying Login Options .................................................. 53
Adding User Accounts ...................................................... 54
Changing User Level.......................................................... 54
Deleting User Accounts .................................................... 54
Resetting User Passwords ............................................... 54
16. Maintaining and Cleaning the Oscar 2 ......................... 55
Cleaning After Use ............................................................. 55
Maintenance and Repairs After Use ............................... 56
Calibration Verification Procedure .................................. 56
17. Limited Warranty ........................................................... 56
Oscar 2 Ambulatory Blood Pressure Monitoring System
............................................................................................... 56
18. Technical Assistance .................................................... 57
19. Radio Frequency Compliance Requirements ............. 58
20. Electromagnetic Compatibility Requirements ............ 58
21. Product Disposal ........................................................... 61
Device ................................................................................... 61
Battery Disposal ................................................................. 61
Cuff ....................................................................................... 61
22. References ..................................................................... 61