Sun-Tech Oscar 2 User manual

USER MANUAL
Available with:
Available with:

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Changes
This manual is identified as Part number: 80-0062-00 Rev. C. 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, Inc. 507 Airport Boulevard, Suite 117
Morrisville, NC 27560 USA
Tel: [phone].654.2300 Fax: [phone]
Email: [e-mail] Web: www.SunTechMed.com
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 Oscar 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. © 2015 SunTech Medical. All rights reserved.

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Table of Contents
Changes............................................................. ii
Copyright Information ........................................ ii
1. Introduction to Ambulatory Blood Pressure
Monitoring .........................................................1
2. Introduction to Central Blood Pressure
Measurement .....................................................2
3. Symbols Used in Labeling ...................................3
4. The Oscar 2 ABPM System with CBP....................5
Indications for Use ...............................................5
Device Operation ................................................6
Products and Accessories ......................................7
Oscar 2 ABPM System (Monitor Options)...............8
Specifications.......................................................8
Safety and Effectiveness Considerations ...............10
Disposal.......................................................... 10
Potential Adverse Reactions .............................. 10
Warnings, Cautions and Contraindications........ 11
About AccuWin Pro™ 4 ......................................17
A Note about HIPPA...........................................17
5. Setting up the Oscar 2 System ..........................18
Powering the Oscar 2 for Use .............................18
Installing AccuWin Pro™ 4 ..................................19
PC System Requirements:................................. 19
Communicating with the Oscar 2........................20
Wireless Communication ....................................20
Pairing Process ................................................ 21
Logging into AccuWin Pro™ 4.............................21
Changing Your Password ....................................22
Changing the Current User.................................22
6. AccuWin Pro™ 4 Layout ....................................23
Toolbar Buttons..................................................23
7. Conducting an Ambulatory
Blood Pressure Study ........................................24
Programming the Oscar 2 for an ABP Study .........24
Parameter Settings ........................................... 27
Fitting a Patient with the Oscar 2 and
SunTech ABPM Cuff............................................29
Preparing and Educating the Patient.....................30
Starting the Study ...............................................31
Finishing the Study .............................................32
8. Notes on Blood Pressure Data...........................33
Retrieving Data from the ABP Monitor..................33
9. Reviewing and Editing an ABP Study..................34
Opening a Patient File........................................34
Viewing an Ambulatory Blood Pressure Study........35
Overview Graph.............................................. 36
Central BP Data............................................... 36
Reviewing an Ambulatory Blood Pressure Study.....39
Entering Comments............................................40

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Changing Awake/Asleep Times ...........................41
Setting BP Threshold Limits..................................42
Setting Pediatric Threshold Limits .........................43
Defining Time-Slice Periods.................................44
Editing Patient Info and Physician Info ..................46
Viewing Dose Response Statistics.........................50
Viewing Time-Slice Statistics ................................51
Viewing Hourly Averages ....................................51
Viewing the Interpretive Report Summary..............52
Comparing Two Studies ......................................53
10. Creating Reports...............................................54
Configuring and Customizing the Report..............54
Previewing the Report .........................................57
Printing the Report..............................................57
Saving the Report as a PDF.................................57
11. Overview of AccuWin Pro™ 4 Report Symbols....58
12. Managing Patient Studies..................................59
Opening a Patient Study .....................................59
Exporting a Patient Study.....................................59
Emailing a Patient Study......................................60
Deleting a Patient Record....................................60
Importing Patient Record.....................................61
Grouping Patient Records ...................................61
13. Customizing and Configuring AccuWin Pro™ 4..63
Hardware Settings..............................................64
Data Settings .....................................................65
Display Settings..................................................66
Diary Comment Settings .....................................67
Email Settings ....................................................68
Report Settings...................................................69
Export Settings ...................................................69
14. Overview of Event Codes ..................................70
Event Code Definitions .......................................70
15. Administrative Tools..........................................72
Specifying Login Options ....................................73
Adding User Accounts ........................................73
Changing User Level ..........................................74
Deleting User Accounts.......................................74
Resetting User Passwords ....................................75
16. Maintaining and Cleaning the Oscar 2..............76
Cleaning after Use .............................................77
Maintenance and Repairs after Use .....................77
Calibration Verification Procedure........................78
17. Limited Warranty ..............................................79
18. Technical Assistance..........................................80
19. Radio Frequency Compliance Requirements ......81
20. Electronic Compatibility System Requirements ...82
21. Product Disposal...............................................85
Device ..............................................................85
Battery Disposal .................................................85
Cuff ..................................................................85
22. References........................................................86

1
Introduction to Ambulatory
Blood Pressure Monitoring
Ambulatory blood pressure monitoring is an accepted clinical tool for collecting multiple blood pressure measurements to
better assist clinicians with the diagnosis and management of hypertension by providing data related to: blood pressure
variability, estimation of true blood pressure, overnight changes in blood pressure, Blood Pressure Load, Sleep Dip, and
morning surge in blood pressure.1In-clinic and home blood pressure measurements cannot provide the same depth of
information that a 24-hour study provides. Several studies have shown that ambulatory blood pressure monitoring, when
compared to clinic or home blood pressure measurement, is superior in predicting target organ damage, morbid events, or
cardiovascular risk.1, 2, 3
The data obtained from ambulatory blood pressure monitors is highly accurate and useful for managing a wide variety of
hypertensive situations including:
• White-coat hypertension
• Resistant hypertension
• Masked hypertension
• Childhood hypertension
• Efficacy 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
1.

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Introduction to Central
Blood Pressure Monitoring
Central blood pressure measurement derives the central aortic pressure waveform from cuff pulsations recorded non-
invasively at the brachial artery. Analysis of the waveform provides key parameters including central systolic pressure, central
pulse pressure and indices of arterial stiffness such as augmentation pressure and augmentation index. Increased central
systolic pressure and augmentation index have been shown to be markers of cardiovascular risk.4Additionally, research has
shown its significance as a biomarker for guiding assessment of drug safety and efficacy and, ultimately, patient treatment.5
2.

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Symbol Description Symbol Description
Item is fragile and should be handled with care during
shipment and storage This product is defibrillator protected
Shipping and storage temperature should be kept
between -20˚ C and 70˚C Manufacturer Contact Information
CE Mark: This product meets the requirements of the
applicable EC directives
Caution: Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
Shipping and storage humidity should be kept between
15% and 95% Device is not made with natural rubber latex
This product and its shipping container should be kept
dry
Indicates the arm circumference which is appropriate for
the cuff
The monitor and the USB cable contain materials which
are hazardous. Must be disposed of properly Cuff index marker
Caution: Consult instructions for use for important
cautionary information
Cuff index marker must fall within this range to use on
patient
Device is not made with PVC Artery marker indicating proper placement – Arrow and
symbol should be placed over the brachial artery
Symbols Used in
Labeling
3.

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Symbol Description Symbol Description
Identifies the manufacturer’s part number Identifies authorized representative in the European
Union
Identifies the monitor’s serial number Manufacture date list as month and year
Mandatory to refer to instruction manual/ booklet for
additional information General mandatory action sign
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.
General warning sign indicates a potentially hazardous
situation which could result in serious injury

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The Oscar 2 ABPM
System with CBP
Indications for Use
The Oscar 2 System is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with
AccuWin Pro, a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and
diastolic blood pressure and heart rate. 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, recording, and display. It makes no diagnoses.
Optionally, The Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of central 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 benefits (excludes pediatric subjects).
BlueTooth, wireless connectivity is available as an option.
4.

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Device Operation
The Oscar 2 monitor is worn by the patient on a waist belt and is connected to a cuff around the non-dominant upper
arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured
by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff. 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 National Standard, Electronic or
Automated Sphygmomanometers.6The 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 efficacy of
the Oscar 2.
The Oscar 2 meets or exceeds all requirements for validation by the International Protocol of the European Society of
Hypertension (ESH)7and the British Hypertension Society (BHS)8. To obtain results of these studies please send a written
request to:
SunTech Medical®
507 Airport Boulevard, Suite 117
Morrisville, NC 27560-8200 USA
or visit our website to review the abstracts: www.suntechmed.com/bp-devices-and-cuffs/ambulatory-blood-pressure-
monitoring/oscar-2#Research_Study_Library.

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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).
Oscar 2 ABPM System (Included Accessories)
Item Description Part Number
Oscar 2 ABP Monitor*97-0150-XX
AccuWin ProTM 4 Software 27-0144-A1
Micro USB Cable 91-0130-00
Oscar 2 Pouch 98-0032-07
Oscar 2 Belt 98-0037-00
Oscar 2 User Guide 80-0062-00
Oscar 2 Quick Start Guide 82-0403-00
ABPM Cuff, Size 2 (25-35 cm) 98-0239-02
ABPM Cuff, Size 3 (32-44 cm) 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 (42-55 cm) 98-0239-04
Oscar 2 ABPM System (Monitor Options)
Item Description Part Number
Oscar 2 ABP Monitor - Standard 99-0133-00
Oscar 2 ABP Monitor - Bluetooth 99-0133-01
Oscar 2 ABP Monitor
w/ SphygmoCor Inside
99-0133-02
Oscar 2 ABP Monitor - Bluetooth w/
SphygmoCor Inside
99-0133-03

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Oscar 2 ABPM System (Monitor Options)
Part Number ABPM Bluetooth SphygmoCor Inside
99-0133-00 
99-0133-01  
99-0133-02  
99-0133-03   
Specifications
Method of Measurement Oscillometric with step deflation
Blood Pressure Range Systolic: 40-260 mmHg
Diastolic: 25-200 mmHg
Heart Rate 40-200 bpm
Maximum Inflate 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 ESH International Protocol, BHS (A/A), and ANSI/AAMI/ISO 81060-2:2013
Operating Conditions 10°C (50°F) to 50°C (122°F)
20-95% RH non-condensing
Ingress Protection Ordinary Equipment, No ingress protection, IPX0.

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Classification Power: Two (2) AA batteries,
continuous operation
Data Memory Flash memory stores up to 250 readings
Calibration Minimally, once every two years
Safety Systems Maximum inflation pressure limited to 300 mmHg; Auto safety release valve for power failure; Maximum
measurement time limited to less than 140 seconds
Sampling Periods 24 independently programmable time periods (Time interval options: none, 5, 10, 15, 20, 30, 45, 60, 90,
and 120 minutes)
International Standards AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012
(Consolidated Text)
EN 60601-1:2006/AC: 2010 ANSI/AAMI/ISO 81060-2:2013
IEC 80601-2-30:2013 IEC 60601-1, 3rd edition (Basic Safety)
EN 15223-1:2012 EN ISO 10993-1:2009 /AC: 2010
EN 60601-1-2:2007 /AC: 2010 EN 62304:2006/AC: 2008
EN 62366:2008 AAMI/ANSI/ISO 15223-1:2012
IEC 60601-1-6 :2010 + A1:2013 IEC 60601-1-11: 2010
Size Approximately 120 x 70 x 35 mm
Weight Approximately 275 g, including batteries
Storage -20° C to +70° C, 15%-95% RH non-condensing
Data USB 2.0 (Micro USB) with optional BluetoothTM 4.0

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Safety and Effectiveness Considerations
The following safety and effectiveness issues are to be considered prior to the usage of the Oscar 2 monitor.
• This device is defibrillator protected.
NOTE: No precautions specific to the Oscar 2 are required during defibrillation, and defibrillation discharge has
no effect on the Oscar 2.
• 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 instructions, 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 accuracy 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 Rumple-Leede
phenomenon (multiple petechia) on the forearm following the application of the cuff, which may lead to Idiopathic

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thrombocytopenia (spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions) or
phlebitis (inflammation of a vein) may be observed.
Warnings, Cautions and Contraindications
Precautions 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 modified
in any way. Ensure pressure compatibility to 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
Specifications page), it may not meet performance specifications. If the cuff fails to deflate, 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 flammable 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 fluid, place fluids 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 monitor if accidental wetting occurs; please return to SunTech Medical® (see Limited
Warranty). Refer to Maintaining and Cleaning the Oscar 2 ABP System, for care instructions.
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.

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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
monitoring equipment on the same limb.
WARNING: Do not use if device is dropped and/or is damaged. Have a qualified 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 inflation can temporarily block blood flow,
potentially causing harm to the patient.
WARNING: Use only with the cuffs supplied by SunTech Medical. Different cuffs have not been validated
with Oscar 2 and measurements with non-validated components may not be accurate.
WARNING: Do not connect the device to equipment that does not meet EN60601-1. When the device is
attached to a patient, the device’s communication port must only be connected to equipment that meets
EN60601-1 standard
WARNING: Use of an ACCESSORY, transducer or cable with ME EQUIPMENT and ME SYSTEMS other than
those specified may result in increased EMISSIONS or decreased IMMUNITY of ME EQUIPMENT or ME SYSTEM.
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: Do not remove monitor covers. The monitor does not contain any user serviceable
components. Return monitor if service is required.

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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.
Repairs should be undertaken only by personnel trained or authorized by SunTech Medical.
CAUTION: The Oscar 2 does not contain any user serviceable internal parts and should only be opened
by an authorized SunTech Medical service representative.
CAUTION: If cuff fails to deflate 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 flow interference and potentially harmful injury to the patient.
CAUTION: Using an incorrect cuff size could result in erroneous and misleading blood pressure
measurement results.
CAUTION: Do not machine wash the cuff bladder.
CAUTION: On hypotensive patients, the device should be used with caution.

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Contraindications
The Oscar 2 ABPM system should be used in conjunction with all other available medical histories and diagnostic test
information about the patient. The following reasons to withhold use of the Oscar 2 ABPM system from a patient:
CONTRAINDICATION: Do not use on patients with erratic, accelerated or mechanically controlled
irregular heart rhythms, including patients with arrhythmias.
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
muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery
or accompanying Raynaud's phenomena or intense cold.

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Time
Shown when the monitor
is not taking a reading.
BP Reading
During a reading, displays the pressure
of the cuff in mmHg.
Immediately after a reading, shows the BP
results in mmHg followed by heart rate in
beats per minute.
Clock
ABP study in progress.
Battery
Indicates low battery;
REPLACE BATTERIES.
Printer
Indicates number of BP readings in memory.
Sun
Indicates AWAKE
portion of study.
Moon
Indicates ASLEEP
portion of the study.
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 5 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 flashing, press the Start/Stop button to take 1st reading.
To Start a Manual BP Reading:
When clock is displayed, press the Start/Stop button.
Dose Response
Event Marker
Allows patient to mark
event or dose.
Systolic/Diastolic
Day/Night Button
Allows patient to switch to ASLEEP
or AWAKE schedule (if allowed).
Oscar 2 At a Glance

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Buttons Functions
Start/Stop TO POWER ON: Press the Start/Stop button.
TO POWER OFF: When the monitor is not taking a measurement, press and hold the Start/Stop button until
you hear five quick beeps, then release.
TO STOP A MEASUREMENT IN PROGRESS: Press the Start/Stop button.
TO START A PROGRAMMED STUDY: When the time is flashing, press the Start/Stop button.
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 flashing, the monitor will turn off in 20 seconds unless an ABP study is started.
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 first, followed by HR in beats per minute.
CBP Check CBP ON Indicates the CBP measurement function is operating properly. This will only appear during the first 30 minutes of the study.
Clock Denotes that a programmed ABP study is in progress.
Sun Denotes that the monitor is collecting readings according to the AWAKE program of the study.
Moon Denotes that the monitor is collecting readings according to the ASLEEP program of the study.
Battery Indicates low battery voltage; BATTERIES NEED TO BE REPLACED.
Printer Indicates the number of readings in memory.