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20. Radio Frequency Compliance Requirements

This equipment needs special precautions regarding EMC and needs to be installed and put into service

according to the EMC information provided in this document. This equipment has been tested and found to

comply with the limits for medical devices to IEC60601-1-2: 2014. These limits are designed to provide rea

sonable protection against harmful interference in a typical medical installation. This equipment generates,

uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruc

tions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that

interference will not occur in a 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 interference by one or more of the following measures:

•

Reorient or relocate the receiving device.

•

Increase the separation between the equipment.

•

Consult the manufacturer or field service technician for help.

•

Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

WARNING:

Use of accessories, transducers, and cables other than those specified may result in increased

emissions or decreased immunity of the Oscar 2.

WARNING:

The Oscar 2 should not be used adjacent to or stacked with other equipment. If adjacent or

stacked use is necessary, the Oscar 2 should be observed to verify normal operation in the configuration in

which it will be used.

Page 73 of 79

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

Содержание 99-0133-00

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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