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
Page 2 of 79 80-0062-00-RevL 2020-9-14

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
Page 3 of 79 80-0062-00-RevL 2020-9-14

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
Page 4 of 79 80-0062-00-RevL 2020-9-14

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.
Page 5 of 79 80-0062-00-RevL 2020-9-14

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
Page 6 of 79 80-0062-00-RevL 2020-9-14

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
Page 7 of 79 80-0062-00-RevL 2020-9-14

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
Page 8 of 79 80-0062-00-RevL 2020-9-14

• 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
Page 9 of 79 80-0062-00-RevL 2020-9-14

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.
Page 10 of 79 80-0062-00-RevL 2020-9-14

Cautions for Use
This monitor is designed to perform in conformity with the description thereof contained in this operation
manual when operated, maintained and repaired in accordance with the instructions provided. The monitor
should not be modied in any way. Ensure pressure compatibility for all patients. If any abnormality occurs in
the monitor, suspend the operation immediately and disconnect it from the patient. If the monitor has been
used or stored outside its acceptable range (see Specications page), it may not meet performance speci-
cations. If the cuff fails to deate, the patient should be instructed on its proper and safe removal.
Warnings
The general warning sign indicates a potentially hazardous situation which could result in serious injury.
WARNING: Do not use in the presence of ammable anesthetics; this could cause an explosion. This device
is not suitable for use in an oxygen enriched environment.
WARNING: Do not immerse the monitor in any uid, place uids on top, or attempt to clean the monitor with
any liquid detergents, cleaning agents, or solvents. This may cause an electrical hazard. Do not use the mon-
itor if accidental wetting occurs; please return to SunTech Medical (see Limited Warranty). Refer to Maintain-
ing and Cleaning the Oscar 2 ABP System, for care instructions.
WARNING: Too frequent measurements can cause injury to the patient due to blood ow interference.
WARNING: The cuff should not be applied over a wound as this can cause further injury.
WARNING: The cuff should not be placed on the arm on the side of a mastectomy. In the case of a double
mastectomy use the side of the least dominant arm.
WARNING: Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitor-
ing equipment on the same limb.
WARNING: Do not use if device is dropped and/or is damaged. Have a qualied service representative check
the monitor before using again.
WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access,
therapy or an arterio-venous (A-V) shunt. The cuff ination can temporarily block blood ow, potentially caus-
ing 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
WARNING: Use of an ACCESSORY, transducer or cable with ME EQUIPMENT and ME SYSTEMS other than
those specied may result in increased EMISSIONS or decreased IMMUNITY of ME EQUIPMENT or ME SYS-
TEM.
WARNING: The Oscar 2 may be interfered with by other equipment even if the other equipment complies
with CISPR Emission Requirements.
WARNING: Performance can be affected by extremes of temperature, humidity and altitude.
Page 11 of 79 80-0062-00-RevL 2020-9-14

WARNING: Do not use the monitor during magnetic resonance imaging (MRI) or in an MRI environment.
Cautions
The caution symbol indicates a potentially hazardous situation which may result in minor or moderate injury.
It may also be used to alert against unsafe practices.
CAUTION: When downloading data from the monitor’s communications USB port, the device should not be
in use with a patient.
CAUTION: Do not remove monitor covers, except to replace batteries. The monitor does not contain any user
serviceable components. Return monitor if service is required.
CAUTION: Do not use on neonates, pediatric patients less than 3 years old, or patients known to be readily
susceptible to bruising.
CAUTION: Do not use the monitor if it has failed its diagnostic self test, or if it displays a greater than zero
pressure with no cuff attached. The values displayed by such a monitor may be inaccurate.
CAUTION: Substitution of a component different from that supplied may result in measurement error. Re-
pairs 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 repaired by
an authorized SunTech Medical service representative. Do not service the product while in use.
CAUTION: If cuff fails to deate within two and a half minutes, instruct patient on manual removal of cuff.
CAUTION: Check that operation of the monitor does not result in prolonged impairment of the circulation of
the patient.
CAUTION: Remove batteries when device is not in use for long periods of time to prevent possible battery
leakage and product damage.
CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood
ow interference and potentially harmful injury to the patient.
CAUTION: Using an incorrect cuff size could result in erroneous and misleading blood pressure measure-
ment results.
CAUTION: Do not machine wash the cuff bladder.
CAUTION: On hypotensive patients, the device should be used with caution.
Contraindications
The Oscar 2 ABPM system should be used in conjunction with all other available medical histories and di-
agnostic test information about the patient. The following are reasons to withhold use of the Oscar 2 ABPM
Page 12 of 79 80-0062-00-RevL 2020-9-14

system from a patient:
CONTRAINDICATION: Do not use on patients with erratic, accelerated or mechanically controlled irregular
heart rhythms, including patients with arrhythmias.
CONTRAINDICATION: Do not use on patients with carotid or aortic valve stenosis.
CONTRAINDICATION: The system is not 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 phenomenon or intense cold.
CONTRAINDICATION: Do not use system on patients who have had a double mastectomy
CONTRAINDICATION: Do not use on the same arm of patients with a peripherally inserted central catheter
(PICC) line, Intraveneous (IV) or arterial line.
Page 13 of 79 80-0062-00-RevL 2020-9-14

6. Oscar 2 At a Glance
Device
1. Start/Stop Button
To Power On:
Press the Start/Stop button.
To Power Off:
When not taking a reading, press and HOLD the Start/Stop button until you hear 8 beeps (approx. 5 seconds),
then release.
To Abort a Measurement:
Press the Start/Stop button any time during a reading.
To Start a Programmed ABP Study:
When time is ashing, press the Start/Stop button to take 1st reading.
To Start a Manual BP Reading:
When clock is displayed, press the Start/Stop button.
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 AWAKE portion of study.
8. Moon - Indicates ASLEEP portion of the study.
9. BP Reading - During a reading, displays the pressure of the cuff in mmHg or kPa. Immediately after a reading,
shows the BP results in mmHg or kPa followed by heart rate in beats per minute.
10. Readings Symbol - Indicates number of BP readings in memory.
11. Measurement unit - indicates the unit of the displayed value in mmHg or kPa (blood pressure) or beats per
minute (heart rate)
Page 14 of 79 80-0062-00-RevL 2020-9-14

Button Functionality
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 eight quick beeps, then release.
TO STOP A MEASUREMENT IN PROGRESS: Press the Start/Stop button.
TO START A PROGRAMMED STUDY: When the time is ashing, press the Start/Stop button.
TO START A SINGLE BP READING: When the time is displayed, press the Start/Stop button.
Day/Night Toggles between day (AWAKE) mode and night (ASLEEP) mode.
Event Marks an event or starts a dose response sequence.
Display Symbols Description
Time 10:45 Indicates current time. When ashing, the monitor will turn off in 20 seconds unless an ABPM
study is in progress.
Pressure 75 mmHg Indicates the pressure of the cuff in mmHg during a measurement.
Reading
Result 120/80 mmHg
Immediately after a measurement is complete, the display shows the results, if enabled. BP
in mmHg is shown rst, followed by HR in beats per minute.
Clock Denotes that a programmed ABP study is in progress.
Sun Denotes the monitor is collecting readings according to the AWAKE program of the study.
Moon Denotes the monitor is collecting readings according to the ASLEEP program of the study.
Battery Indicates 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 operating properly. This will only appear during
the rst 30 minutes of the study.
Setting Up The Oscar 2 System
Setting up the Oscar 2 System involves powering the Oscar 2, installing AccuWin Pro 4 on a personal com-
puter (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.
Powering the Oscar 2 for Use
Install two alkaline (2) AA batteries in the bay located at the back of the monitor. The bay shows the orien-
tation in which the batteries should be placed. When batteries are properly loaded, the monitor’s display will
show the following:
1. Incrementing dashes
2. Software and safety version of the monitor
3. Battery voltage followed by three quick audible beeps
4. The number of BP readings in memory followed by one long audible beep
5. Time ashing
The monitor is now ready to be used.
NOTE: Replace with fully charged batteries prior to the start of a new study.
NOTE: Ensure batteries are inserted with the correct polarity. Improper installation will prevent the monitor from
functioning. Batteries are required for Oscar 2 use at all times including programming, scheduling and retriev-
ing.
Page 15 of 79 80-0062-00-RevL 2020-9-14

NOTE: Install batteries before connecting Oscar 2 to PC via USB.
NOTE: Device will not re-charge batteries via USB connection.
CAUTION: Remove batteries when device is not in use for long periods of time to prevent possible battery
leakage and product damage.
Installing AccuWin Pro 4
A more detailed installation guide is available in the AccuWin Pro 4 Quick Start Guide (82-0403-00).
PC System Requirements
•Windows 10, 8 or 7 SP1 (32 or 64 bit)
•SVGA or compatible display adapter and monitor. Minimum 1280 x 1024 recommended resolution
•One available USB A port
•Minimum 4GB of RAM
•Minimum of 30GB of disk space for patient database
NOTE: Install 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 your PC (Figure 1; part B).
Figure 1: Connecting the Oscar 2 to a PC
NOTE: The cable can be left connected when the PC is off and the monitor is not connected to a patient.
Communicating with the Oscar 2
To successfully complete an ambulatory blood pressure (ABP) study: Connect the Oscar 2 to the PC then
program the study in the downloaded application from your PC. When the patient returns you will again use
the application on your computer to retrieve the collected data.
Wireless Communications
The Oscar 2 may be equipped with an optional Bluetooth™ module, that will allow communications with wire-
A B
Page 16 of 79 80-0062-00-RevL 2020-9-14

less home network devices, mobile phones, and other appropriate devices. For details on how to connect to
these devices, please contact your authorized SunTech Medical service representative.
True24 Mobile Application
The True24 ABPM Patient Diary mobile app is designed to work with the SunTech Medical Oscar 2™ ambula-
tory blood pressure monitor during a physician prescribed ABPM study.
Following each daytime awake blood pressure measurement, the True24 mobile app prompts the patient to
enter information about their activity, posture or any symptoms experienced while the BP measurement was
taken. This diary information can assist the clinician with understanding the ambulatory blood pressure study
data and making hypertension treatment decisions.
The True24 Mobile Application works only with the Apple iOS platform, and must be downloaded by the phy-
sician onto the patient’s phone from the iTunes App store using the search word ’True24’
After the mobile application has been downloaded, the physician can access training information that can be
found on the application to learn how to:
•Connect the phone to Oscar 2
•Use the True24 Home Screen
•Use the True24 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 application, and follow the
instructions below to establish proper pairing.
To enter Bluetooth Pairing mode on the Oscar 2:
1. Simultaneously press the two buttons indicated in Figure 2 until the 5 long beep pattern is heard, and
the LCD display shows “bt Pr”.
2. Upon successful pairing with a Bluetooth host, the Oscar 2 will emit one long beep, and the LCD Dis-
play will briey show “bt con”. The Oscar 2 will exit the pairing mode and connect to the paired Blue-
tooth host.
3. 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 the process and exit pairing mode.
•The pairing process may be restarted by performing step 1, above.
(The doctor has to train the user on the proper use of the app, including this next step.)
While using the mobile True24 app, if the app does not prompt the user for a diary entry after a BP reading is
completed, it is suggested that the user check pairing using the instructions on the True24 Mobile App.
It is recommended that True24 mobile app is not used during dosage sequence due to interference with the
dosage schedule.
Page 17 of 79 80-0062-00-RevL 2020-9-14

Figure 2: Press buttons indicated
Logging in to AccuWin Pro 4
If your AccuWin Pro 4 administrator enables login security, you must enter a valid user name and password
when you open AccuWin Pro 4 or change the current user. See Admin Tools for more information. If login
security is not enabled, no login is necessary.
NOTE: The AccuWin Pro 4 administrator can program AccuWin Pro 4 to automatically log a user off after a
specied time of inactivity elapses. If you are logged off, you must log back in again.
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 rst time, you must change
the default password assigned to you. You must be logged in under your name before you can change your
password.
1. To change your password:
2. From the Congure menu, select Admin Tools.
3. Click Change Password.
4. Enter your current password.
5. Enter your new password. It can be alphanumeric and it must be at least 6 characters.
6. Re-enter your new password to conrm it.
7. Click OK.
NOTE: If you forget your password, you must ask the AccuWin Pro 4 administrator to reset it.
Page 18 of 79 80-0062-00-RevL 2020-9-14

Changing the Current User
To change the current user:
1. From the Congure 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-RevL 2020-9-14

7. AccuWin Pro 4 Layout
AccuWin Pro 4 gives you the exibility 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 func-
tions. The menu bar allows you to access all functions of the software.
Toolbar Buttons
Program: Opens the Program Monitor
Retrieve: Initiates 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: Prints the report page of the displayed data
PDF: Saves the report for the open ABP study in PDF format
Export: Exports the study in a format and location set by the user.
Settings: Opens the Conguration options window
Help: Opens the online help window
Exit: Closes AccuWin Pro 4
Languages: Enables the user to change the application language.
Page 20 of 79 80-0062-00-RevL 2020-9-14