Sun-Tech Oscar 2 User manual

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

1. User Manual
Changes
This manual is identied as Part number: 80-0062-00. An updated version may be available for download
from the SunTech Medical website. Should you notice errors or omissions in this manual, please notify us at:
SunTech Medical
517 Airport Blvd, Morrisville, USA.
Tel: [phone]
800.421.8626
Fax: [phone]
Email: CustomerSupport@
SunTechMed.com
Web: SunTechMed.com
This manual is for the Oscar 2, Ambulatory Blood Pressure Monitor (ABPM) System.
CAUTION: US Federal law restricts this device to sale by or on the order of a licensed practitioner
Copyright Information
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. SunTech and Bravo are registered trademarks
of SunTech Medical, Inc. SphygmoCor is a registered trademark of AtCor Medical Pty. Ltd., Sydney Australia.
All other trademark names are the trademarks of their respective holders. The information in this manual
is furnished for guidance only, is subject to change without notice, and should not be construed as a
commitment by SunTech Medical. SunTech Medical assumes no liability for errors or inaccuracies that may
appear in this manual. © 2020 SunTech Medical. All rights reserved.
Manufacturer Information
SunTech Medical, Inc.
507 Airport Blvd, #117
Morrisville, NC 27560-8200
Phone: [phone]
1-800-421-8626
Fax: [phone]
EMERGO Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
SunTech Medical (Shenzhen) Co., Ltd.
105 HuanGuan South Road, Suite 15
2~3/F
DaHe Community Guanlan,
LongHua District, Shenzhen
GuangDong PRC 518110
Tel: + 86-755-29588810
 + 86-755-29588986 (Sales)
 + 86-755-29588665 (Service)
Fax: + 86-755-29588829
First registered June 2015
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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
Specications ....................................................................................................................................................................................................... 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
Dening 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
Conguring and Customizing the Report .....................................................................................................................................................48
Previewing the Report .......................................................................................................................................................................................50
Printing the Report.............................................................................................................................................................................................51
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Saving the Report as a PDF .............................................................................................................................................................................51
12. Overview of AccuWin Pro 4 Report Symbols..............................................................................52
13. Managing Patient Studies .........................................................................................................53
Opening a Patient Study ...................................................................................................................................................................................53
Exporting a Patient Study .................................................................................................................................................................................53
Emailing a Patient Study ..................................................................................................................................................................................53
Deleting a Patient Record ................................................................................................................................................................................54
Importing a Patient Record ..............................................................................................................................................................................54
Grouping Patient Records ................................................................................................................................................................................54
14. CustomizingandConguringAccuWinPro4 ............................................................................56
Hardware Settings .............................................................................................................................................................................................56
Customizing Export Templates .......................................................................................................................................................................56
Data Settings ......................................................................................................................................................................................................57
Display Settings..................................................................................................................................................................................................58
Diary Comment Settings ..................................................................................................................................................................................59
Email Settings .....................................................................................................................................................................................................61
Report Settings ..................................................................................................................................................................................................61
Export Settings ...................................................................................................................................................................................................62
15. Overview of Event Codes...........................................................................................................65
Event Code Denitions ......................................................................................................................................................................................65
16. Administrative Tools .................................................................................................................67
Specifying Login Options .................................................................................................................................................................................67
Adding User Accounts ......................................................................................................................................................................................68
Changing User Level .........................................................................................................................................................................................68
Deleting User Accounts ....................................................................................................................................................................................68
Resetting User Passwords ...............................................................................................................................................................................69
17. Maintaining and Cleaning the Oscar 2 .......................................................................................69
Cleaning After Use .............................................................................................................................................................................................69
Maintenance and Repairs After Use ..............................................................................................................................................................70
Calibration Verication Procedure ..................................................................................................................................................................70
18. Limited Warranty.......................................................................................................................71
Oscar 2 Ambulatory Blood Pressure Monitoring System ..........................................................................................................................71
19. Technical Assistance................................................................................................................72
20. Radio Frequency Compliance Requirements..............................................................................73
21. Electromagnetic Compatibility System Requirements ...............................................................74
22. Product Disposal.......................................................................................................................77
Device ...................................................................................................................................................................................................................77
Battery Disposal .................................................................................................................................................................................................77
23. References ...............................................................................................................................78
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2. Introduction to Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring (ABPM) is an accepted clinical tool for collecting multiple blood pres-
sure measurements. ABPM data is intended 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 blood pressure dipping, and morning surge
in blood pressure. In-clinic and home blood pressure measurements cannot provide the same depth of in-
formation that a 24-hour study provides. Several studies have shown that ambulatory blood pressure moni-
toring, when compared to clinic or home blood pressure measurement, is superior in predicting target organ
damage, morbid events, or cardiovascular risk.
The data obtained from ambulatory blood pressure monitors is accurate and useful for managing a wide
variety of hypertensive situations including:
•White-coat hypertension
•Resistant hypertension
•Masked hypertension
•Childhood hypertension
•Efcacy of anti-hypertensive drug therapy on a 24-hour basis
•Nocturnal hypertension
•Episodic hypertension and/or anxiety disorders
•Hypotensive symptoms
•Changes in diet and daily routine designed to reduce hypertension
3. 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 pres-
sure and augmentation index. Increased central systolic pressure and augmentation index have been shown
to be markers of cardiovascular risk. Additionally, research has shown its signicance as a biomarker for
guiding assessment of drug safety and efcacy and, ultimately, patient treatment.
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4. Symbols Used in Labeling
Symbol Description Standard/Source
General Warning Sign ISO 7010-W001
Batch Code ISO 7000-2492
Caution ISO 7000-0434A
Refer to Instruction Manual ISO 7010-M002
Authorized representative in the European Community ISO 15223-1
USB Industry
Consult Instructions for Use ISO 7000-1641
This product meets the requirements of the applicable
Directives EU Directive
Disposal in compliance with WEEE Directive WEEE 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 index line must fall within range markings Manufacturer
Arrow should be placed over artery Manufacturer
Symbol indicating limb circumference Manufacturer
Index line Manufacturer
Not made with natural rubber latex Manufacturer
Not made with PVC Manufacturer
Reference Number ISO 7000-2493
This product is Type BF debrillator protected IEC 60417-5334
Fragile, handle with care ISO 7000-0621
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Shipping and storage humidity should be kept between 15%
to 95% ISO 7000-2620
Shipping and storage temperature should be kept between
-20˚ C to 70˚C ISO 7000-0632
This product and its shipping container should be kept dry ISO 7000-0626
Start/Stop a BP measurement Manufacturer
5. The Oscar 2 ABPM System
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 4, a PC-based computer program for the recording and displaying of up to 250 mea-
surements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct
to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient’s systolic
and diastolic blood pressures over an extended period of time. The system is only for measurement, record-
ing, and display to assist a licensed physician in making a diagnosis.
Optionally, the Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of cen-
tral arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.
It is to be used on those patients where information related to ascending aortic blood pressure is desired but
the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benets (ex-
cludes pediatric subjects).
Bluetooth wireless connectivity is 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 inated 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 occlud-
ed by pressure in the cuff. Heart rate is determined by the frequency of the pressure waves detected.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained
observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American Na-
tional Standard, Electronic or Automated Sphygmomanometers . The Korotkoff sounds heard over the artery
below the compression cuff vary in character as the pressure in the cuff is reduced from above systolic
toward zero, or atmospheric pressure. They are divided into phases. Phase 1 (K1) or systolic begins with the
sudden appearance of a faint, clear tapping or thumping sound that gradually increases in intensity. Phase 5
(K5) or diastolic begins when silence develops, and was used to determine overall efcacy of the Oscar 2.
The Oscar 2 meets or exceeds all requirements for validation by the International Protocol of the Europe-
an Society of Hypertension (ESH) and the British Hypertension Society (BHS) and ISO 81060-2. To obtain
results of these studies please send a written request to:
SunTech Medical®
517 Airport Blvd, Morrisville, USA
Or visit the manufacturer website to review the abstracts: SunTechMed.com
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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).
For additional information on how these accessories t together consult the Oscar 2 Quick Start Guide (82-
0403-00).
Oscar 2 ABPM System (Included Accessories)
Item Description Part Number
Oscar 2 ABP Monitor 99-0133-00
AccuWin Pro 4 27-0144-A1
USB Cable 91-0143-00
ABP Monitor Belt 98-0037-00
ABP Monitor Shoulder Strap 98-0036-00
Oscar 2 Pouch 98-1020-00
Oscar 2 User Guide 80-0062-00
Oscar 2 Quick Start Guide 82-0403-00
ABPM Cuff, Size 2 (26cm-34cm) 98-0239-02
ABPM Cuff, Size 3 (32cm-44cm) 98-0239-03
* See table “Oscar 2 ABPM System (Monitor Options)” to 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) 98-0239-04
Oscar 2 ABPM System (*Monitor Options)
Item Description Part Number
Oscar 2 Standard 99-0133-00
Oscar 2 with Bluetooth 99-0133-01
Oscar 2 with SphygmoCor 99-0133-02
Oscar 2 with SphygmoCor and Bluetooth 99-0133-03
About AccuWin Pro 4
AccuWin Pro 4 is a simple software application designed for exclusive use with the Oscar 2 monitor and
which allows for maximum exibility in the conguration, analysis, interpretation, and reporting of ABPM
studies.
A personal computer is needed as an accessory but it is not provided.
PC System Requirements:
• Windows 7 or later
• SVGA or compatible display adapter and monitor. Minimum 1280 x 1024 recommended resolution
• One available USB port
• Minimum 4GB of RAM
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• Minimum of 30GB of HDD space for patient database
A Note About HIPAA
The regulations set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) cover a
number of topics, two of which present possible compliance issues for healthcare providers using a software
application, such as AccuWin Pro 4: privacy and security.
Password-controlled user access and encrypted patient information capabilities of AccuWin Pro 4 assist
health care providers in maintaining a HIPAA compliant environment. Since HIPAA compliancy is ultimately
the responsibility of the provider, please be aware that report printouts, report PDF les, and exported data
contain unencrypted patient information and should be handled appropriately.
Biocompatibility and Applied Parts
The ABPM cuff is the only Applied Part (AP) of the Oscar 2 system. All AP have been evaluated for biocom-
patibility in conjunction with the applicable standards.
Specications
Method of
Measurement
Oscillometric with step deation
Blood Pressure Range Systolic: 40-260 mmHg
Diastolic: 25-200 mmHg
Heart Rate Range 40-200 bpm
Maximum Inate
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-
invasive accuracy:
±5 mmHg mean error & 8 mmHg standard deviation.
Validations Clinically validated to ANSI/AAMI/ISO 81060-2:2013, BHS (A/A), and ESH
International Protocol.
Operating Conditions
Shipping/Storage
Conditions
10°C (50°F) to 50°C (122°F)
20-95% RH non-condensing
-20°C (°F) to 70°C (°F)
15-95% RH non-condensing
Classication Continuous operation
Power: Two (2) AA batteries, alkaline
Data Memory Flash memory stores up to 250 readings
Calibration Check
Recommendation
Minimally, once every two years
Safety Systems Maximum ination 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, and 120 minutes)
Parameter Standard EU Norm
Safety AAMI/ANSI ES60601-1:2005/(R) 2012
+A1:2012
EN 60601-1 :2006/A1:2013/ IEC
60601-1: 2005/A1:2012
Blood Pressure IEC 80601-2-30 :2009 + A1:2013 N/A
Usability IEC 60601-1-6 :2013 Ed. 3.1
IEC 62366:2015 Ed. 1.0
EN 60601-1-6 :2010
EN 62366:2008
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EMC/EMI/ESD IEC60601-1-2:2014 EN 60601-1-2:2015
Home Use IEC 60601-1-11:2015 Ed. 2.0 EN IEC 60601-1-11:2010
Biocompatibility ISO 10993-1:2009/(R)2013
ISO 10993-5:2009
ISO 10993-10:2010
EN ISO 10993-1:2009/AC:2010
EN ISO 10993-5:2009
N/A
Software IEC 62304:2015 EN IEC 62304:2006/AC:2008
Symbols ISO 15223-1:2016 EN ISO 15223-1:2016
Sphygmomanometers ANSI/AAMI/ISO 81060-2:2013 EN ISO 81060-1:2012
Quality ISO 13485:2016 EN ISO 13485:2016
Risk Management ISO 14971:2007 (Ed. 2) EN ISO 14971:2012
Size Approximately 100 x 70 x 30 mm
Weight Approximately 233 g, including batteries
Storage Conditions -20° C to +70° C, 15%-95% RH non-condensing
Data USB 2.0 (Micro USB)
Safety and Effectiveness Considerations
The following safety and effectiveness issues are to be considered prior to the usage of the Oscar 2 monitor.
NOTE: This device is debrillator protected. No precautions specic to the Oscar 2 are required during debrilla-
tion, and debrillation discharge has no effect on the Oscar 2.
•The monitor is intended for use following consultation and instruction by a physician.
•The reliability of the device is dependent upon conformance with the operation and service instruc-
tions, as detailed in this manual.
•This device has been designed for use on patients with normal 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 or her physical
condition, and use outside the operating instructions detailed in this manual.
•Safety and effectiveness of central blood pressure measurements on children under the age of 18
years of age, pregnant women and neonates have not been tested.
Disposal
This symbol indicates that the monitor contains materials which may be hazardous to human health. This
product complies with the WEEE Directive. Please return the Oscar 2 monitor to SunTech Medical for proper
disposal. Please dispose of other materials according to local regulations.
Potential Adverse Reactions
Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of
urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense
itching) caused by the fabric material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the skin) formation or Rum-
ple-Leede phenomenon (multiple petechia) on the forearm following the application of the cuff, which may
lead to idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets associated
with hemorrhagic conditions) or phlebitis (inammation of a vein) may be observed.
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