SunTech Oscar 2 User Manual
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SunTech Oscar 2 User Manual

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Summary of Contents for SunTech Oscar 2

  • Page 1 Available with: Available with: USER MANUAL...

  • Page 2: Changes

    All content in this manual is the proprietary information of SunTech Medical and is provided solely for purposes of operation, maintenance or service of the Oscar 2 ABPM System. This manual and the Oscar 2 ABPM System described in it are protected under copyright law under which they may not be copied, in whole or in part, without written consent of SunTech Medical.

  • Page 3: Table Of Contents

    Conducting an Ambulatory Indications for Use ..........5 Blood Pressure Study ........24 Device Operation ..........6 Programming the Oscar 2 for an ABP Study ..24 Products and Accessories ........7 Parameter Settings ........... 27 Oscar 2 ABPM System (Monitor Options) ....8 Fitting a Patient with the Oscar 2 and SunTech ABPM Cuff ..........29...
  • Page 4 Previewing the Report .........57 Resetting User Passwords ........75 Printing the Report ..........57 16. Maintaining and Cleaning the Oscar 2 ....76 Saving the Report as a PDF .........57 Cleaning after Use ..........77 11. Overview of AccuWin Pro™ 4 Report Symbols ..58 Maintenance and Repairs after Use .....77...

  • Page 5: Introduction To Ambulatory Blood Pressure Monitoring

    Introduction to Ambulatory Blood Pressure Monitoring Ambulatory blood pressure monitoring is an accepted clinical tool for collecting multiple blood pressure measurements to better assist clinicians with the diagnosis and management of hypertension by providing data related to: blood pressure variability, estimation of true blood pressure, overnight changes in blood pressure, Blood Pressure Load, Sleep Dip, and morning surge in blood pressure.

  • Page 6: Introduction To Central Blood Pressure

    Introduction to Central Blood Pressure Monitoring Central blood pressure measurement derives the central aortic pressure waveform from cuff pulsations recorded non- invasively at the brachial artery. Analysis of the waveform provides key parameters including central systolic pressure, central pulse pressure and indices of arterial stiffness such as augmentation pressure and augmentation index. Increased central systolic pressure and augmentation index have been shown to be markers of cardiovascular risk.

  • Page 7: Symbols Used In Labeling

    Symbols Used in Labeling Symbol Description Symbol Description Item is fragile and should be handled with care during This product is defibrillator protected shipment and storage Shipping and storage temperature should be kept Manufacturer Contact Information between -20˚ C and 70˚C CE Mark: This product meets the requirements of the Caution: Federal (U.S.A.) law restricts this device to sale applicable EC directives...
  • Page 8 Symbol Description Symbol Description Identifies authorized representative in the European Identifies the manufacturer’s part number Union Identifies the monitor’s serial number Manufacture date list as month and year Mandatory to refer to instruction manual/ booklet for General mandatory action sign additional information Caution symbol indicates a potentially hazardous General warning sign indicates a potentially hazardous...

  • Page 9: The Oscar 2 Abpm System With Cbp

    Indications for Use The Oscar 2 System is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate.

  • Page 10: Device Operation

    Device Operation The Oscar 2 monitor is worn by the patient on a waist belt and is connected to a cuff around the non-dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff.

  • Page 11: Products And Accessories

    Products and Accessories The Oscar 2 System should contain the following items. If you are missing any item please contact SunTech Medical immediately (see Limited Warranty for contact information). Oscar 2 ABPM System (Included Accessories) Oscar 2 ABPM Optional Accessories...

  • Page 12: Oscar 2 Abpm System (Monitor Options)

    Oscar 2 ABPM System (Monitor Options) Part Number ABPM Bluetooth SphygmoCor Inside  99-0133-00   99-0133-01   99-0133-02    99-0133-03 Specifications Method of Measurement Oscillometric with step deflation Blood Pressure Range Systolic: 40-260 mmHg Diastolic: 25-200 mmHg...
  • Page 13 Classification Power: Two (2) AA batteries, continuous operation Data Memory Flash memory stores up to 250 readings Calibration Minimally, once every two years Safety Systems Maximum inflation pressure limited to 300 mmHg; Auto safety release valve for power failure; Maximum measurement time limited to less than 140 seconds Sampling Periods 24 independently programmable time periods (Time interval options: none, 5, 10, 15, 20, 30, 45, 60, 90,...

  • Page 14: Safety And Effectiveness Considerations

    Safety and Effectiveness Considerations The following safety and effectiveness issues are to be considered prior to the usage of the Oscar 2 monitor. • This device is defibrillator protected. NOTE: No precautions specific to the Oscar 2 are required during defibrillation, and defibrillation discharge has no effect on the Oscar 2.

  • Page 15: Warnings, Cautions And Contraindications

    This may cause an electrical hazard. Do not use the monitor if accidental wetting occurs; please return to SunTech Medical® (see Limited Warranty). Refer to Maintaining and Cleaning the Oscar 2 ABP System, for care instructions.
  • Page 16 (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient. WARNING: Use only with the cuffs supplied by SunTech Medical. Different cuffs have not been validated with Oscar 2 and measurements with non-validated components may not be accurate.
  • Page 17 CAUTION: Substitution of a component different from that supplied may result in measurement error. Repairs should be undertaken only by personnel trained or authorized by SunTech Medical. CAUTION: The Oscar 2 does not contain any user serviceable internal parts and should only be opened by an authorized SunTech Medical service representative.
  • Page 18 Contraindications The Oscar 2 ABPM system should be used in conjunction with all other available medical histories and diagnostic test information about the patient. The following reasons to withhold use of the Oscar 2 ABPM system from a patient: CONTRAINDICATION: Do not use on patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patients with arrhythmias.

  • Page 19: Oscar 2 At A Glance

    Oscar 2 At a Glance Moon Indicates ASLEEP portion of the study. Indicates AWAKE portion of study. BP Reading Time During a reading, displays the pressure Shown when the monitor of the cuff in mmHg. is not taking a reading.
  • Page 20 Buttons Functions Start/Stop TO POWER ON: Press the Start/Stop button. TO POWER OFF: When the monitor is not taking a measurement, press and hold the Start/Stop button until you hear five quick beeps, then release. TO STOP A MEASUREMENT IN PROGRESS: Press the Start/Stop button. TO START A PROGRAMMED STUDY: When the time is flashing, press the Start/Stop button.

  • Page 21: About Accuwin Pro™ 4

    About AccuWin Pro AccuWin Pro™ 4 is a simple software application designed for exclusive use with the Oscar 2 monitor and which allows for maximum flexibility in the configuration, analysis, interpretation, and reporting of ABPM studies. A Note About HIPPA...

  • Page 22: Setting Up The Oscar 2 System

    Setting Up The Oscar 2 System Setting up the Oscar 2 System involves powering the Oscar 2, installing AccuWin Pro™ 4 on a PC, and connecting the Oscar 2 to the PC. The Oscar 2 ABPM system is packaged with everything you need to start. See Product and Accessories for complete contents.

  • Page 23: Installing Accuwin Pro™ 4

    Oscar 2 device and download the installation file for AccuWin Pro 4. After download is complete, run the install file on your PC. If you do not have internet access, please contact SunTech Medical customer support for assistance.

  • Page 24: Communicating With The Oscar 2

    SunTech Medical service representative. The Oscar 2 may be used with approved software applications to enhance the management of data from the device to various patient data systems. Please contact your authorized SunTech Medical service representative to verify compatibility...

  • Page 25: Pairing Process

    2 will exit the pairing mode and connect to the paired Bluetooth host. The Oscar 2 will remain in pairing mode for approximately 3 minutes. • If no host is paired at the end of 3 minutes, the Oscar 2 will stop advertising and will exit pairing mode.

  • Page 26: Changing Your Password

    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 default password assigned to you. You must be logged in under your name before you can change your password. To change your password: 1.

  • Page 27: Accuwin Pro™ 4 Layout

    AccuWin Pro Layout AccuWin Pro™ 4 gives you the flexibility to program the ABP monitor the way you want and the simplicity to collect and retrieve important test data. The toolbar provides easy, one-click access to frequently used functions. The menu bar allows you to access all functions of the software.

  • Page 28: Conducting An Ambulatory Blood Pressure Study

    2. Enter the desired parameter settings in the form (Figure 3). (See Parameter settings.) 3. Click one of the following: • Program to transfer the information to the Oscar 2. An indicator bar shows the progress and disappears when programming is successfully completed.
  • Page 29 3. Click one of the following: • Program to transfer the information to the Oscar 2. An indicator bar shows the progress and disappears when programming is successfully completed. • Cancel to close the dialog box.
  • Page 30 To create a template: 1. In the open Program Monitor window, enter the desired parameter settings in the form. See Parameter settings. 2. Click Save in the upper right-hand corner. 3. In the Assign Template Name dialog box, type a name for the template and click Save.

  • Page 31: Parameter Settings

    Parameter Settings The parameters can be adjusted as follows: Standard Tab Patient name, Patient ID Enter patient name (first, middle, last) and patient ID for reporting and referencing data. Arm measured Select Left or Right, and check Dominant, if applicable. Site number Enter up to 12 numeric characters.
  • Page 32 Manual readings When on, allows the patient to take measurements outside of the scheduled program using the Start/Stop key. NOTE: Manual Readings is always ON for the first 30 minutes of the study. Type Select the type of manual reading the patient can take: Brachial BP Only or Brachial BP w/ Central BP. Audible alerts When on, an alert sounds at the beginning and upon completion of each reading, during the awake period only.

  • Page 33: Fitting A Patient With The Oscar 2 And Suntech Abpm Cuff

    Fitting a Patient with the Oscar 2 and SunTech ABPM Cuff After you have successfully programmed the Oscar 2 using AccuWin Pro™ 4, you may begin fitting the patient with the monitor and a blood pressure cuff. Cuffs may be used on either arm.

  • Page 34: Preparing And Educating The Patient

    4. Attach to patient Insert the Oscar 2 into its pouch with the display showing through the window. Attach the pouch to the patient using the belt (Figure 7).

  • Page 35: Starting The Study

    CBP values. The cuff will then be fully deflated. The clock icon should appear on the display of the Oscar 2 indicating that the study is in progress.

  • Page 36: Finishing The Study

    If you wish to finish the study before the patient returns, instruct the patient to turn off the monitor by holding down the Start/ Stop button for five (5) seconds. The Oscar 2 will beep five (5) times and the display will turn off.

  • Page 37: Notes On Blood Pressure Data

    Retrieving Data from the ABP Monitor To retrieve the data: 1. Connect the Oscar 2 to the computer. 2. In AccuWin Pro™ 4, click the Retrieve toolbar button, or select Retrieve Data from the Monitor menu. The dialog box on the screen shows the progress as the data is transferred. After completion, a dialog box appears to confirm patient details.

  • Page 38: Reviewing And Editing An Abp Study

    Reviewing and Editing an ABP Study Opening A Patient File AccuWin Pro™ 4 will automatically open a patient file directly after the data is retrieved. 1. From the File menu, select Open. Alternatively, from the toolbar, click the BP Data button. 2.

  • Page 39: Viewing An Ambulatory Blood Pressure Study

    Viewing An Ambulatory Blood Pressure Study In the upper portion of the ABP Data tab, a table displays the results for each of the BP measurements taken or attempted during the study. The table also includes events recorded by the patient and dose response sequences. To display only these events in the table, select Events Only from the Show pull-down menu.

  • Page 40: Overview Graph

    Central BP Data The Central BP Data tab provides a detailed view of individual CBP measurements taken during the study. If your Oscar 2 is configured with the SphygmoCor Inside technology, you will be able to collect, display, and analyze these parameters. The tab will display the number, time and date of the selected reading along with the following: Average Central Pressure Waveform: A graphical representation of the derived average central pressure waveform.
  • Page 41 Central Diastolic Pressure (cDIA): The minimum pressure during aortic ejection. Central Pulse Pressure (cPP): Represents the height of the aortic pressure waveform. cPP can also be described as the difference between the maximum and minimum of the central pressure waveform, or cSYS minus cDIA. Aortic cPP greater than 50 mmHg has been shown to predict cardiovascular disease.
  • Page 42 Systolic Pressure (SP) Augmented Pressure (AP) Augmentation Index AIx = (AP/PP)x100% Pulse Pressure (PP) Systolic Diastolic Diastolic Pressure (DP) 100 200 300 700 800 Time (ms) Ejection Duration (ED) Figure 9: Explanation of Central Blood Pressure Waveform Characteristics AASI Graph The AASI Graph tab is optional, and can be enabled by selecting Ambulatory Arterial Stiffness Index on the Report>Configuration>Data (see Customizing and Configuring AccuWin Pro™...

  • Page 43: Reviewing An Ambulatory Blood Pressure Study

    Figure 10: AASI Graph Reviewing an Ambulatory Blood Pressure Study In the ABP Data view, you can review an ABP study for accuracy and context. When the data is retrieved by AccuWin Pro™ 4, all readings in an ABP study that have event codes will be “tagged” in the first column of the table. Tagged records are omitted from the analysis of the ABP study displayed in the Statistics and Hourly Averages views, but these readings can be printed in the report.

  • Page 44: Entering Comments

    To assist the patient with tracking their activities, a patient diary template is available for printing from the Download Library on the SunTech Medical website. To enter a patient comment from the table: 1. Highlight the reading to which you want to add a comment, and select the corresponding cell in the Comments column.

  • Page 45: Changing Awake/Asleep Times

    To enter a comment from the graph: 1. Select the reading in the ABP data graph to which you want to add a comment. This causes the corresponding row in the table to be highlighted. 2. Right-click the mouse and select Set comment from the Figure 12: Text Entry Box for Setting a New Comment menu.

  • Page 46: Setting Bp Threshold Limits

    To change time period start times: 1. Display an ABP study and choose the Threshold tab. 2. Click Edit Awake/Asleep Times. 3. In the Times tab (Figure 12), reset the patient’s asleep and awake times to the nearest half-hour by moving the appropriate sliders right or left.

  • Page 47: Setting Pediatric Threshold Limits

    Brachial Thresholds Brachial thresholds can be set for Awake and Asleep systolic and diastolic BP . The default setting is a global threshold set to 140/90 mmHg for Awake periods and 120/80 mmHg for Asleep periods. If desired, you can set thresholds to match a published standard using the corresponding buttons: JNC7/AHA or ESH.

  • Page 48: Defining Time-Slice Periods

    To apply a pediatric threshold: 1. Open a study in the ABP Data tab. Within the Overview Graph tab, navigate to the Threshold tab located to the right of the graph view. 2. Click Pediatric Thresholds. 3. Enter the patient’s gender and height. The height may be entered in centimeters (cm), inches, or feet/ inches.
  • Page 49 3. Once the time-slice is selected, a Time-Slice Settings box (Figure 17) will appear and allow the user to name the time- slice and edit the start and end times, if necessary. 4. Click Save to create the new time-slice. To edit a time-slice: 1.

  • Page 50: Editing Patient Info And Physician Info

    To delete a time-slice: 1. Display the ABP study. Choose the Time-Slice tab. 2. Choose a time-slice from the drop-down menu. The time-slice period will be highlighted on the ABP data graph. 3. Choose Delete. Click Yes to delete the time-slice (Fig. 18). Figure 18: Deleting Time Slice (Confirmation Window) Editing Patient Info and Physician Info Patient and physician information may be entered when data is retrieved from the monitor or after the patient file is saved.
  • Page 51 To edit Physician Info (Fig. 20): 1. Click the Physician Info tab at the bottom of the screen. 2. Click on the Edit button. 3. Update any information and click Save. Alternatively, you may click Cancel to discard all changes. Users are able to enter and edit Patient History, Reason for Test, Current Medications, and Physican Interpretation.
  • Page 52 To locate and choose a previously stored entry: 1. Either start to type an entry or choose the down arrow with your mouse. As more characters of the desired entry are typed, a list of matching entries will be displayed. 2.
  • Page 53 In the Statistics tab, each table includes the mean, standard deviation, coefficient of variation (CV), minimum value, and maximum value for the following parameters: brachial and central systolic, brachial and central diastolic, brachial and central MAP , brachial and central pulse pressure, central augmentation index, central augmentation index at 75 bpm, and central augmentation pressure.

  • Page 54: Viewing Dose Response Statistics

    • Smoothness Index: Smoothness Index (SI) is the ratio between the average of the blood pressure changes computed for each hour of the recording and its standard deviation. SI is generally used to evaluate the effectiveness of antihypertensive treatment as it shows the averaged trend of blood pressure reduction between two studies. •...

  • Page 55: Viewing Time-Slice Statistics

    Viewing Time-Slice Statistics To view the statistical analysis for user defined time-slice periods, click on the Time- Slice Statistics tab (Figure 23). Viewing Hourly Averages To display trends in a patient’s ABP study, click the Hourly Averages tab at the bottom of the window (Figure 24). The table shows the average BP readings for each hour the patient was tested.

  • Page 56: Viewing The Interpretive Report Summary

    Use the check boxes at the top of each column to select the statistics you would like to see displayed in the graph at the bottom of the page. You can resize the table and zoom in on the graph with your mouse pointer. (For instructions on resizing and zooming, see Viewing an Ambulatory Blood Pressure Study.) Viewing the Interpretive Report Summary This window (Fig.

  • Page 57: Comparing Two Studies

    Comparing Two Studies To further enhance the utility of ABPM, you may want to measure the progress of a patient’s blood pressure by conducting multiple studies. AccuWin Pro™ 4 allows for the comparison of the hourly averages and statistics for two studies conducted on the same patient.

  • Page 58: Creating Reports

    Physician Info tab), 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 Patient Info tab), and test date. The footer of each page identifies the type of monitor used and the page number.
  • Page 59 You can choose from the following pages to customize your report (listed in the order the pages will print, see Figure 26): • Summary: The Interpretive Summary appears above the data graph and summary statistics. Summary brachial and peak central BP statistics for the overall, awake, asleep, and white coat (if chosen) periods include: mean systolic and diastolic, mean heart rate, BP load, and asleep dip.
  • Page 60 To configure report details (Figure 27): 1. Click the Details tab. From here you can control the following parameters for printing reports: • Overview Graph Type: Select line, bar, or the type of graph currently displayed according to the type you want to print on the Summary page of the report.

  • Page 61: Previewing The Report

    Previewing The Report 1. From the Report menu, select Preview. Alternatively, click the Print Preview toolbar button. The Print Preview window is displayed (Figure 28). 2. To scroll through the report pages, click on the numbered icons on the left side of the window, or select the page you want to view using the drop down menu.

  • Page 62: Overview Of Accuwin Pro™ 4 Report Symbols

    Indicates that this reading was a retry reading. Retries are readings that are automatically obtained 4 minutes after a measurement attempt fails or a questionable reading is obtained by the monitor. The exclamation point is a permanent tag and is used when an accurate reading cannot be determined by the Oscar 2. >...

  • Page 63: Managing Patient Studies

    Managing Patient Studies Opening a Patient Study This feature allows you to retrieve and view a patient study. 1. From the toolbar, click the BP Data button or from the File menu, select Open. The Open ABP Study – Select Patient dialog box appears listing all available patient files.

  • Page 64: Emailing A Patient Study

    Emailing a Patient Study To email AccuWin Pro™ 4 data files as an attachment: 1. From the File menu, select Email. 2. Choose either to email the Displayed File or select files From Database. If displayed File is chosen, the data currently displayed on the screen is emailed.

  • Page 65: Importing Patient Record

    Importing a Patient Record You may import patient studies that are saved on your computer, so that the files are stored in the main AccuWin Pro™ 4 patient database. To import patient studies: 1. Click File then select Import > Import Patient Study. 2.
  • Page 66 To move patients between groups: 1. Click File then select Patient Management. 2. Using the checkboxes to 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.

  • Page 67: Customizing And Configuring Accuwin Pro

    Customizing and Configuring AccuWin Pro It may be helpful to have multiple configuration profiles for your users, for example, one for each physician in the practice. To create or edit configuration profiles in AccuWin Pro™ 4: 1. From the Configure menu, select Preferences. 2.

  • Page 68: Hardware Settings

    Hardware Settings The Hardware Settings window (Figure 29) allows you to configure your computer to communicate with your ABP monitor via a specified port. You may also test the settings that you have selected. 1. On the tool bar, click on Monitor, then choose Configuration Port. 1.

  • Page 69: Data Settings

    Data Settings The Data Settings tab (Figure 30) allows you to configure the following settings: Data Source: Select how heart rate, Morning Surge, and Smoothness Index are displayed or calculated (i.e. using brachial or central BP values). A lower- case “c” will designate which values are set to use central BP values (e.g. HR becomes cHR).

  • Page 70: Display Settings

    Display Settings This feature allows you to customize the color scheme of the graphs and charts (Figure 31). Customizable palettes allow you to fine-tune the color scheme for optimum reproduction by your printer. Shading on the graph indicates the period of the study. The default colors (which can be changed using the Configuration>Display tab) are the following: •...

  • Page 71: Diary Comment Settings

    Diary Comment Settings You can use this feature to keep track of entries from patient diaries describing the patient’s activities during BP measurements. The entries in this window (Figure 32) are a default list which can be customized by adding, editing, or deleting entries. The entries in this list are incorporated into a list that appears in the pull-down menu under the Diary Comments column located on the ABP Data tab.

  • Page 72: Email Settings

    Email Settings The Email feature creates a new email message, attaches selected patient data files or programming templates, and sends the email to a specified destination. To set up email for AccuWin Pro™ 4 (Figure 33): 1. Choose the type of connection you are using by selecting LAN or Dial up. 2.

  • Page 73: Export Settings

    4. To create a new report, click New Report, enter a name, and select the pages you want to appear in the report. 5. To delete any of these reports, select the report and click Delete Report. 6. Enter a Report Title by typing the title of your choice in the box provided. The title appears as a header on each page of the report.

  • Page 74: Overview Of Event Codes

    Overview of Event Codes Event Codes (EC) are used during the review of ABPM data. The codes are displayed in the table on the ABP Data tab and in the Reviewed and Omitted BP data report pages under the columns labeled EC. Event Codes describe the conditions under which the BP measurement was taken.
  • Page 75 Code Description in AccuWin Pro™ 4 Solution or Response Reading aborted – safety time-out Retry the reading by pushing the Start/Stop button. If the problem persists, return the unit for service. Reading aborted – cuff over- pressure Check for blocks or kinks in the air hose. Service required –...

  • Page 76: Administrative Tools

    3. The first time you access Admin Tools, you must use the default user name and password provided when the Figure 35: Admin Tools Window AccuWin ProTM 4 was downloaded. For assistance, please visit www.suntechmed.com or contact SunTech Medial customer support. See section 18, Technical Assistance, for contact information.

  • Page 77: Specifying Login Options

    Specifying Login Options AccuWin Pro™ 4 includes the flexibility of enabling or disabling login security, which requires users to log in with a password. Enabling this option supports the HIPAA access protection requirements. If your facility uses an Electronic Medical Record (EMR) system or another system that already provides login security, you may not want to enable login security in AccuWin Pro™...

  • Page 78: Changing User Level

    To add a new 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 the user. 4.

  • Page 79: Resetting User Passwords

    Resetting User Passwords When a user forgets his or her password, that user must contact the AccuWin Pro™ 4 administrator, who will reset the user’s password to the default password of “user.” When he or she first logs in again, the user must change the default password before being able to perform any tasks in AccuWin Pro™...

  • Page 80: Maintaining And Cleaning The Oscar 2

    Service and support, including relevant accessories, will be available up to 7 years following the last date this product is manufactured by SunTech Medical. For a list of service centers, see section 18,...

  • Page 81: Cleaning After Use

    Oscar 2 The Oscar 2 monitor cannot be sterilized. DO NOT immerse the monitor in any fluid, or attempt to clean with any liquid detergents, cleaning agents, or solvents. You may use a soft, damp cloth to remove dirt and dust from the monitor. If the unit does become immersed in water, do not use;...

  • Page 82: Calibration Verification Procedure

    Calibration Verification Procedure It is recommended that you check the accuracy of the Oscar 2 once every two years. If needed, an authorized service center may recalibrate the pressure transducers in the monitor. To verify calibration, the Oscar 2 must first be placed into the proper mode.

  • Page 83: Limited Warranty

    SunTech Medical will repair any component(s) or part(s) that it finds to be defective during the period of this limited warranty. Should a defect become apparent, the original purchaser should notify SunTech Medical of the suspected defect.

  • Page 84: Technical Assistance

    For any questions, please reference the Help section within the software, this user manual, or our website. If these do not fully address your problem, please contact our service department. USA, Canada, and Latin America Europe, Middle East, and Africa Asia-Pacific SunTech Medical, Inc. SunTech Medical, Ltd. SunTech Medical, Ltd. 507 Airport Blvd, #117 Oakfield Industrial Estate...

  • Page 85: Radio Frequency Compliance Requirements

    Radio Frequency Compliance Requirements This device contains a transmitter module identified by FCC ID: XDULE40-D2 and Industry Canada: IC 8456A-LE4D2. It has been tested and found to comply with the limits for a Class B device. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

  • Page 86: Electronic Compatibility System Requirements

    Electromagnetic Compatibility System Requirements The Oscar 2 needs special precautions regarding EMC and needs to be installed and put into service according to the electromagnetic compatibility information that is listed below. WARNING: The use of an ACCESSORY, transducer or cable with ME EQUIPMENT and ME SYSTEMS other than those specified may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
  • Page 87 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SunTech Oscar 2 device is used exceeds the applicable RF compliance level above, the SunTech Oscar 2 device should be observed to verify normal operation.
  • Page 88 Recommended separation distances between portable and mobile RF communications equipment and the SunTech Oscar 2 device The SunTech Oscar 2 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment.

  • Page 89: Product Disposal

    Battery Disposal The SunTech Oscar 2 device contains a lithium ion battery that contains materials which may be hazardous to human health. Do NOT dispose of battery in domestic waste! Instead, please dispose of in an environmentally responsible way, or return the battery to SunTech Medical. A prepaid return label can be obtained.

  • Page 90: References

    Sphygmomanometer. Arlington, VA: AAMI; 1996. Jones SC, Bilous M, Winship S, Finn P , Goodwin J. Validation of the Oscar 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood Pressure Monitoring 2004;...
  • Page 91 11. O’Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia G, et al. European Society of Hypertension recommendations for conventional, ambulatory, and home blood pressure measurement. Journal of Hypertension 2003; 21: 821-848. 12. Urbina E, Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, et al. Ambulatory blood pressure monitoring in children and adolescents: Recommendations for standard assessment, a scientific statement from the American Heart Association, Atherosclerosis, Hypertension, and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young and the Council for High Blood Pressure Research.
  • Page 92 SunTech Medical, Inc. SunTech Medical, Ltd. SunTech Medical, Ltd. 507 Airport Boulevard, Suite 117 Oakfield Industrial Estate 105 HuanGuan South Road, Suite 15 2~3/F Morrisville, NC 27560-8200 USA Stanton Harcourt Road DaHe Community Guanlan, Tel: + 1.919.654.2300 Eynsham, Oxfordshire OX29 4TS LongHua District, Shenzhen 1.800.421.8626...

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