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SunTech 99-0133-00, Manual

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Table of Contents

1.  User Manual ................................................................................................................................2

Changes .................................................................................................................................................................................................................

2

Copyright Information .........................................................................................................................................................................................

2

Manufacturer Information..................................................................................................................................................................................

2

2.  Introduction to Ambulatory Blood Pressure Monitoring ...............................................................5

3.  Introduction to Central Blood Pressure Monitoring ......................................................................5

4.  Symbols Used in Labeling ...........................................................................................................6

5.  The Oscar 2 ABPM System .........................................................................................................7

Indications for Use ..............................................................................................................................................................................................

7

Device Operation ..................................................................................................................................................................................................

7

Products and Accessories .................................................................................................................................................................................

8

About AccuWin Pro 4 ..........................................................................................................................................................................................

8

A Note About HIPAA ............................................................................................................................................................................................

9

Biocompatibility and Applied Parts ..................................................................................................................................................................

9

Specifications .......................................................................................................................................................................................................

9

6.  Oscar 2 At a Glance ...................................................................................................................14

Button Functionality ..........................................................................................................................................................................................

15

Setting Up The Oscar 2 System ......................................................................................................................................................................

15

Powering the Oscar 2 for Use .........................................................................................................................................................................

15

Installing AccuWin Pro 4 ..................................................................................................................................................................................

16

Communicating with the Oscar 2 ...................................................................................................................................................................

16

Wireless Communications ...............................................................................................................................................................................

16

True24 Mobile Application ...............................................................................................................................................................................

17

Logging in to AccuWin Pro 4 ...........................................................................................................................................................................

18

Changing Your Password .................................................................................................................................................................................

18

Changing the Current User ..............................................................................................................................................................................

19

7.  AccuWin Pro 4 Layout ...............................................................................................................20

 Toolbar Buttons .................................................................................................................................................................................................

20

8.  Conducting an Ambulatory Blood Pressure Study ......................................................................21

Programming the Oscar 2 for an ABP Study ................................................................................................................................................

21

Study Parameter Settings ................................................................................................................................................................................

24

Fitting a Patient with the Oscar 2 and ABPM Cuff ......................................................................................................................................

26

Preparing and Educating the Patient .............................................................................................................................................................

27

Starting the Study ..............................................................................................................................................................................................

28

Finishing the Study ............................................................................................................................................................................................

28

9.  Notes on Blood Pressure Data ...................................................................................................29

Retrieving Data from the ABP Monitor ..........................................................................................................................................................

29

10.  Reviewing and Editing an ABP Study .........................................................................................29

Opening A Patient File .......................................................................................................................................................................................

29

Patients, Studies and Orders ...........................................................................................................................................................................30
Viewing an Ambulatory Blood Pressure Study ............................................................................................................................................31
Reviewing an Ambulatory Blood Pressure Study ........................................................................................................................................33
Entering Comments ..........................................................................................................................................................................................34
Setting BP Threshold Limits ............................................................................................................................................................................36
Setting Pediatric Threshold Limits .................................................................................................................................................................37
Defining Time-Slice Periods .............................................................................................................................................................................38
Editing Patient Info and Physician Info ..........................................................................................................................................................

41

Viewing Dose Response Statistics .................................................................................................................................................................

44

Viewing Hourly Averages ..................................................................................................................................................................................

45

Viewing the Interpretive Report Summary ....................................................................................................................................................

46

Comparing Two Studies ...................................................................................................................................................................................

47

11.  Creating Reports .......................................................................................................................48

Configuring and Customizing the Report .....................................................................................................................................................

48

Previewing the Report .......................................................................................................................................................................................

50

Printing the Report.............................................................................................................................................................................................

51

Page 3 of 79

80-0062-00-RevL 2020-9-14

Summary of Contents for 99-0133-00

Page 1: ...24 Hour Ambulatory BP Monitoring System Page 1 of 79 80 0062 00 RevL 2020 9 14...

Page 2: ...whole or in part without written consent of SunTech Medical SunTech and Bravo are registered trademarks of SunTech Medical Inc SphygmoCor is a registered trademark of AtCor Medical Pty Ltd Sydney Aust...

Page 3: ...uttons 20 8 Conducting an Ambulatory Blood Pressure Study 21 Programming the Oscar 2 for an ABP Study 21 Study Parameter Settings 24 Fitting a Patient with the Oscar 2 and ABPM Cuff 26 Preparing and E...

Page 4: ...ort Settings 62 15 Overview of Event Codes 65 Event Code Definitions 65 16 Administrative Tools 67 Specifying Login Options 67 Adding User Accounts 68 Changing User Level 68 Deleting User Accounts 68...

Page 5: ...ccurate and useful for managing a wide variety of hypertensive situations including White coat hypertension Resistant hypertension Masked hypertension Childhood hypertension Efficacy of anti hypertens...

Page 6: ...EE Directive Manufacturer ISO 7000 3082 Date of Manufacture ISO 7000 2497 Serial Number ISO 7000 2498 CAUTION Federal U S A law restricts this device to sale by or on the order of a physician FDA Cuff...

Page 7: ...s available as an option Device Operation The Oscar 2 monitor is worn by the patient on a waist belt and is connected to a cuff around the non domi nant upper arm The cuff is inflated automatically at...

Page 8: ...determine the part number and description for your Oscar 2 ABP Monitor Oscar 2 ABPM Optional Accessories Item Description Part Number ABPM Cuff Size 1 18 26 cm 98 0239 01 ABPM Cuff Size 4 42cm 55cm 9...

Page 9: ...e 40 200 bpm Maximum Inflate Pressure 280 mmHg Accuracy Heart Rate accurate within 2 or 3 bpm whichever is greater Blood Pressure results meet or exceed ANSI AAMI ISO 81060 2 2013 standards for non in...

Page 10: ...mal sinus rhythms The interpretation of blood pressure measurements should only be made by a physician The accura cy of any blood pressure recording may be affected by the position of the subject his...

Page 11: ...e instructions WARNING Too frequent measurements can cause injury to the patient due to blood flow interference WARNING The cuff should not be applied over a wound as this can cause further injury WAR...

Page 12: ...ized by SunTech Medical CAUTION The Oscar 2 does not contain any user serviceable internal parts and should only be repaired by an authorized SunTech Medical service representative Do not service the...

Page 13: ...ot applicable in generalized constriction or localized spasm of muscu lar conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accom panying Raynaud s phenomen...

Page 14: ...ton 2 Event Marker 3 Day Night Button Display 4 Time Shown when the monitor is not taking a reading 5 Battery Indicates low battery REPLACE BATTERIES 6 Clock ABP study in progress 7 Sun Indicates AWAK...

Page 15: ...ndicates low battery voltage BATTERIES NEED TO BE REPLACED Save Symbol Indicates the number displayed indicates the number of readings in memory CBP Check CBP Indicates the CBP measurement function is...

Page 16: ...AccuWin Pro 4 before connecting the USB cable to the computer 1 Connect the USB cable to the USB connector on the ABP monitor Figure 1 part A 2 Connect the USB end of the cable to the USB port on you...

Page 17: ...rue24 Diary Entries Prepare the patient for Sleep Tips for a Successful Study Using the Oscar 2 Pairing Process Once the True24 Application is downloaded from the Apple App Store launch the applicatio...

Page 18: ...n To log in enter a valid user name and password then click OK Changing Your Password If you know your current password you can change it If you are logging in for the first time you must change the d...

Page 19: ...e Current User To change the current user 1 From the Configure menu select Admin Tools 2 Click Change User 3 Enter a valid user name 4 Enter a valid password 5 Click Login Page 19 of 79 80 0062 00 Rev...

Page 20: ...data retrieval from the monitor BP Data Opens the Open ABP Study Select Patient window Print Preview Previews a report for the open ABP study Print Prints a report for the open ABP study Print Page Pr...

Page 21: ...igure 3 Programming the Oscar 2 Standard Tab To program the monitor 1 Click the Program button on the toolbar Alternatively from the Monitor menu select Program study 2 Optionally complete the Patient...

Page 22: ...ne Help Figure 4 Programming the Oscar 2 Patient Information Window To create a patient in the database before conducting a study 1 In the Programming Monitor window click the button for Select Create...

Page 23: ...art the online Help Figure 5 Available Templates Window To create a template 1 In the open Programming Monitor window enter the desired parameter settings in the form See Parameter settings 2 Click th...

Page 24: ...nt ID Patient ID for reporting and referencing data Patient Name Enter patient name first middle last Patient Date of Birth The date of birth for the patient Study Reference A reference to an order or...

Page 25: ...20 alphanumeric characters Time zone difference Adjust the monitor s clock to the time zone that the patient is in relative to your time zone The PC Time and Monitor Time fields are populated automati...

Page 26: ...cuff range If the arm is within range this cuff size is correct for your patient If the marker is outside the RANGE indicator select a new cuff size as indicated by color CAUTION Using an incorrect cu...

Page 27: ...is on the patient can start a measurement at any time by press ing the Start Stop button momentarily The cuff should not be removed between BP measurements Before sleeping the patient should make sure...

Page 28: ...d rcd 01 appears on the display Subsequent recordings use 02 03 and so on The monitor can record up to 30 events If the patient tries to record more than 30 events the monitor beeps four times and No...

Page 29: ...save the retrieved data 2 Click Yes The Patient information dialog box appears Enter patient information in the data fields 4 Click OK to save the data 5 If the alert for adjusting Awake and Asleep t...

Page 30: ...prior to the completion of a study for example if a reason for test is provided before a study is retrieved from the monitor Each study in a patient file contains data that is displayed in the views...

Page 31: ...he scale of the vertical axis represents blood pressure mmHg and heart rate bpm The horizontal axis displays the time in clock hours Clicking on any point measurement or event in the graph highlights...

Page 32: ...or cSYS minus cDIA Aortic cPP greater than 50 mmHg has been shown to predict cardiovascular disease Central Augmentation Pressure cAP cAP is a measure of the pressure wave reflected back from lower b...

Page 33: ...h BP values to use in the graph and calculations by selecting Brachial BP Values or Central BP Values near the bottom of the legend Figure 11 AASI Graph Reviewing an Ambulatory Blood Pressure Study In...

Page 34: ...e and select Toggle Tag from the menu NOTE All changes made to the ABP study are saved immediately Entering Comments Use the Comments column the right most column in the table to keep track of patient...

Page 35: ...n event marked by the patient Click the event s checkmark above the graph to cycle through the following selections symbol comment Event marked Rx Dosage Sx Symptom The selected symbol replaces the ch...

Page 36: ...les custom thresholds apply to all studies for a particular patient To define thresholds 1 Open a study in the ABP Data tab Within the Overview Graph tab navigate to the Threshold tab locat ed to the...

Page 37: ...ided the default values will be set to 130 mmHg for central systolic BP and 50 mmHg for central pulse pressure No settings will be established for augmented pressure or augmentation index There is als...

Page 38: ...table to use either Wuhl et al 2002 or Soergel et al 1997 5 Click Apply Figure 16 Pediatric Threshold Calculator NOTE The pediatric threshold is applied as a custom brachial BP threshold which applie...

Page 39: ...select the starting time of the time slice period then drag the mouse to the end time Releasing the mouse button determines the ending time of the time slice The selected time slice will be highlight...

Page 40: ...ph 3 Click Edit The Time Slice Settings box Figure 18 will appear 4 Edit the name or the start and end times 5 Click Save to save the settings To delete a time slice 1 Display the ABP study Choose the...

Page 41: ...ton at the bottom of the screen 3 Update any patient information and click Save Alternatively you may click Cancel to discard all changes Figure 20 Patient Info Tab To edit Physician Info Figure 21 1...

Page 42: ...s Enter or Tab on the keyboard or use your mouse to move the cursor to the Dosage column 3 Enter Dosage and Frequency in the same manner Predefined entries in the Frequency column are listed below 4 O...

Page 43: ...or the displayed ABP study click on the Statistics tab This window initially shows the following tables Overall Data for the complete ABPM study Awake Period Data collected while the patient is awake...

Page 44: ...he Coefficient of Variation CV can be used as a measure of BP variability which can be a determinant of end organ damage 18 CV is calculated as the standard deviation divid ed by the mean blood pressu...

Page 45: ...g the diastolic from the systolic reading It is another hemodynamic parameter that may serve as an indicator for cardiovascular risk Pulse pressure is provid ed using both brachial PP and central cPP...

Page 46: ...ck the Summary tab on the bottom of the screen and select one of the following options for interpretation Joint National Committee Seventh Report JNC 7 and American Heart Association AHA 8 guidelines...

Page 47: ...y you want to use as a reference for comparison by highlighting it and clicking OK The statistics generated during the previous study are now incorporated into the Hourly Averages window The table exp...

Page 48: ...Statistics ABP Data and Monitor Configuration pages Full report All report pages NOTE All report pages include the SunTech Medical logo patient demographics all information from the Pa tient Info tab...

Page 49: ...listed in the order the pages will print see Figure 27 Summary The Interpretive Summary appears above the data graph and summary statistics Sum mary brachial and peak central BP statistics for the ove...

Page 50: ...c BP heart rate MAP PRP and PP Monitor Configuration Shows the programmed time period dosage response and monitor settings for the study The page also displays the quality control results for the stud...

Page 51: ...printer Print the report page corresponding to the current tab that is being displayed by clicking Print Page Saving the Report as a PDF To save the report as an Adobe Portable Document Format PDF fr...

Page 52: ...e and below it If the omitted reading seems to be acceptable un tag it from the ABP Data tab if it does not seem acceptable leave it tagged r Indicates that this reading was a retry reading Retries ar...

Page 53: ...ge the list of files you want to export Click Configure to configure the details of the exported file s For instructions on configuring export see Export in Customizing and Configuring AccuWin Pro 4 T...

Page 54: ...lick File then select Import Import Patient Study 2 Click Browse Files A Windows Explorer Window will appear to allow you to select the patient study files or folder that you would like to import 3 Se...

Page 55: ...the left of the dialog box select the patients that you would like to manage 3 Click Move Patient 4 Select the Group Name using the drop down menu from the dialog box 5 Click OK A confirmation window...

Page 56: ...ol bar click on Monitor then choose Configuration Port 2 Under ABP device select your monitor type 3 Under Serial port select the port into which you have plugged the device 4 Click Test port You will...

Page 57: ...g brachi al or central BP values A lower case c will designate which values are set to use central BP values e g HR becomes cHR Additional calculations Select which additional parameters will be displ...

Page 58: ...h is the first hour of the study appears only if enabled Light green shading Indicates a dose response period appears only if programmed Light teal shading Indicates the periods used to calculate Morn...

Page 59: ...he patient s activities during BP measurements The entries in this window Figure 33 are a default list which can be customized by add ing editing or deleting entries The entries in this list are incor...

Page 60: ...uration window To delete a diary comment 1 In the Diary Comments tab of the Configuration window select the diary comment that you want to delete 2 Click Delete 3 Click OK To edit a diary comment 1 In...

Page 61: ...or office network administrator Your ISP may require you to check the Authorize box in order for you to send email 3 The Email settings you fill in will appear in the header of your email the name of...

Page 62: ...ettings ASCII files can be imported into Excel using the Excel csv import wizard ASCII file export configuration Delimiter Options Quoted strings surround strings with quotation marks Quoted numbers s...

Page 63: ...port PDF Settings Choose the report format to be used for the exported PDF report Export Button The Export Button can be configured to export in a predetermined format when pressed Export Options Expo...

Page 64: ...placed with the value shown below Data Field Placeholder Text Patient ID PATID First Name FIRST Last Name LAST Date of Birth DOB Study Reference STUDYREF Study Date DATE Current Time TIME AWP User USE...

Page 65: ...p button If problem persists return the unit for service 85 Reading aborted blocked valves or pneumatics Check the air hose connections and make certain the air tubing is not crimped 86 Reading aborte...

Page 66: ...d comment 111 Day to night mode switch If desired adjust ABP Data graph to match the time marked by the patient 112 Night to day mode switch If desired adjust ABP Data graph to match the time marked b...

Page 67: ...administrative name and pass word and click OK The window appears if you have not logged in as an administrator or if login security is not enabled 3 The first time you access Admin Tools you must us...

Page 68: ...ew user 1 In the Admin Tools window click New User 2 In the User Name field that appears enter the new user login name 3 In the Select Role field use the drop down menu to select the level role for th...

Page 69: ...rn missing incomplete damaged or contaminated Contact the nearest authorized service center should repair or replacement become necessary Further the user of the device bears sole responsibility for a...

Page 70: ...neumatic hoses and the monitor case for cracks fraying or kinks DO NOT use the monitor or cuff if there are any signs of damage Please contact our service department if any damage or defects are ident...

Page 71: ...ace cables etc 90 days SunTech Medical Inc warrants each instrument to be free from defects in material and workmanship Liabili ty under this warranty covers servicing of the instruments when returned...

Page 72: ...user manual or our website If these do not fully address your problem please contact our service department SunTech Medical 517 Airport Blvd Morrisville USA Tel 919 654 2300 800 421 8626 Fax 919 654...

Page 73: ...particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the inte...

Page 74: ...me Healthcare Environment and is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buil...

Page 75: ...nce calculated from the equation applicable to the frequency of the transmitter Minimum separation distance for higher IMMUNITY TEST LEVELS shall be calculated using the following equation E 6 d P Whe...

Page 76: ...rvey should be considered If the measured field strength in the location in which the monitor is used exceeds the applicable RF compliance level above the monitor should be observed to verify normal o...

Page 77: ...e or sep arate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is con...

Page 78: ...g TG Hall JE Appel LJ Falkner BE Graves J Hill MN et al Recommendations for blood pressure measurement in humans and experimental animals Part 1 Blood pressure measurement in humans A statement for pr...

Page 79: ...Grassi G Mechanisms and clinical implications of blood pressure variability Journal of Cardiovascular Pharmacology 2000 35 7 Suppl 4 S15 9 19 Parati G Schumacher H Bilo G Mancia G Evaluating 24 h anti...

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