24-Hour Ambulatory BP Monitoring System User

24-Hour Ambulatory BP Monitoring System User
Available with:
Available with:
USER MANUAL
Changes
ii
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: 800.421.8626
919.654.2300 Fax: 919.654.2301
Email: CustomerService@SunTechMed.com 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.
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
iii
iv
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.1 In-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
2.
Introduction to Central
Blood Pressure Monitoring
Central blood pressure measurement derives the central aortic pressure waveform from cuff pulsations recorded noninvasively 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.4 Additionally, research has
shown its significance as a biomarker for guiding assessment of drug safety and efficacy and, ultimately, patient treatment.5
2
3.
Symbols Used in
Labeling
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
3
Symbol
4
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
4.
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.
5
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.6 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 efficacy of
the Oscar 2.
6
The Oscar 2 meets or exceeds all requirements for validation by the International Protocol of the European Society of
Hypertension (ESH)7 and 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-pressuremonitoring/oscar-2#Research_Study_Library.
Products and Accessories
The Oscar 2 System should contain the following items. If you are missing any item please contact SunTech Medical
immediately (see Limited Warranty for contact information).
*
Oscar 2 ABPM System (Included Accessories)
Oscar 2 ABPM Optional Accessories
Item Description
Part Number
Item Description
Part Number
Oscar 2 ABP Monitor*
97-0150-XX
ABPM Cuff, Size 1 (18-26 cm)
98-0239-01
AccuWin Pro
27-0144-A1
ABPM Cuff, Size 4 (42-55 cm)
98-0239-04
TM
4 Software
Micro USB Cable
91-0130-00
Oscar 2 Pouch
98-0032-07
Oscar 2 ABPM System (Monitor Options)
Oscar 2 Belt
98-0037-00
Item Description
Part Number
Oscar 2 User Guide
80-0062-00
Oscar 2 ABP Monitor - Standard
99-0133-00
Oscar 2 Quick Start Guide
82-0403-00
Oscar 2 ABP Monitor - Bluetooth
99-0133-01
ABPM Cuff, Size 2 (25-35 cm)
98-0239-02
99-0133-02
ABPM Cuff, Size 3 (32-44 cm)
98-0239-03
Oscar 2 ABP Monitor
w/ SphygmoCor Inside
Oscar 2 ABP Monitor - Bluetooth w/
SphygmoCor Inside
99-0133-03
See table "Oscar 2 ABPM System (Monitor Options)" to determine the part
number and description for your Oscar 2 ABP Monitor.
7
Oscar 2 ABPM System (Monitor Options)
Part Number
99-0133-00
99-0133-01
99-0133-02
99-0133-03
ABPM




Bluetooth
SphygmoCor Inside




Specifications
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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.
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
9
Safety and Effectiveness Considerations
The following safety and effectiveness issues are to be considered prior to the usage of the Oscar 2 monitor.
10
• 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
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.
11
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.
12
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.
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.
13
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.
14
Oscar 2 At a Glance
Sun
Indicates AWAKE
portion of study.
Time
Shown when the monitor
is not taking a reading.
Battery
Indicates low battery;
REPLACE BATTERIES.
Clock
ABP study in progress.
Systolic/Diastolic
Dose Response
Event Marker
Allows patient to mark
event or dose.
Moon
Indicates ASLEEP
portion of the study.
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.
Printer
Indicates number of BP readings in memory.
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.
Day/Night Button
Allows patient to switch to ASLEEP
or AWAKE schedule (if allowed).
15
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.
Marks an event or starts a dose response sequence.
Event
Display Symbols
Time
16
Description
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.
About AccuWin ProTM 4
AccuWin Pro™ 4 is a simple software application designed for exclusive use with the Oscar 2 monitor and which allows for
maximum flexibility in the configuration, analysis, interpretation, and reporting of ABPM studies.
A Note About HIPPA
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 compliancy issues for health care 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 files, and exported data contain unencrypted patient information
and should be handled appropriately.
17
5.
Setting Up The
Oscar 2 System
Setting up the Oscar 2 System involves powering the Oscar 2, installing AccuWin Pro™ 4 on a PC, and connecting the
Oscar 2 to the PC.
The Oscar 2 ABPM system is packaged with everything you need to start. See Product and Accessories for complete contents.
Powering the Oscar 2 for Use
18
Install two (2) AA batteries in the bay located at the back of the monitor. The bay shows the orientation in which the batteries
should be placed. When batteries are properly loaded, the monitor’s display will show the following:
1. Incriminting 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 flashing
The monitor is now ready to be used.
NOTE: Ensure batteries are inserted with the correct polarity. Improper installation will prevent the monitor from functioning.
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
PC System Requirements
• Windows 8.1, 7 (32 or 64 bit) or XP
• SVGA or compatible display adapter and monitor. Minimum 1280 x 1024 recommended resolution
• One available USB port
• Minimum 4GB of RAM
• Minimum of 30GB of HDD space for patient database
NOTE: Standard install of AccuWin ProTM Pro 4 does not support a server license. If you would like to support multiple users in a network
system, this will require a custom install. Please visit www.suntechmed.com or contact SunTech Medical customer support for assistance.
To install AccuWin Pro™ 4:
Visit www.suntechmed.com/software to register the Oscar 2 device and download the installation file for AccuWin ProTM
4. After download is complete, run the install file on your PC. If you do not have internet access, please contact SunTech
Medical customer support for assistance.
After installing AccuWin Pro™ 4, you can connect the Oscar 2 to the computer. See Communicating with the Oscar 2.
NOTE: The USB cable should not be connected to the computer before AccuWin Pro™ 4 is installed.
19
Communicating with the Oscar 2
To successfully complete an ABP study, you need to connect the
ABP monitor to the PC in order to program the study and later to
retrieve the collected data.
To connect the monitor to your computer:
1. Connect the Oscar 2 USB cable to the micro-USB connector
at the bottom of 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).
The drivers required for using the Oscar 2 USB cable will be
loaded when you install AccuWin Pro™ 4.
20
(a)
(b)
Figure 1: Connecting the Oscar 2 to a PC
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.
NOTE: The cable can be left connected when the PC is off.
Wireless Communications
The Oscar 2 may be equipped with an optional Bluetooth™
module, that will allow communications with
wireless 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.
The Oscar 2 may be used with approved software applications to enhance the management of data from the device to
various patient data systems. Please contact your authorized SunTech Medical service representative to verify compatibility
with your desired application.
Pairing Process
Once you have established that your application is compatible with the Oscar 2, please
follow the instructions below to establish proper pairing
To enter Bluetooth Pairing mode on the Oscar2;
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 Display will briefly show “bt con”. Upon successful pairing, the Oscar
2 will exit the pairing mode and connect to the paired Bluetooth 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 advertising and
will exit pairing mode.
• At this point the Oscar2 will no longer be visible to Bluetooth hosts.
• The pairing process may be restarted by performing step 1, above.
21
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.
NOTE: The AccuWin Pro™ 4 administrator can program AccuWin Pro™ 4 to automatically log a
user off after a specified 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.
Figure 2: Press buttons indicated
Changing Your Password
If you know your current password, you can change it. If you are logging in for the first time, you must change the default
password assigned to you. You must be logged in under your name before you can change your password.
To change your password:
1.From the Configure menu, select Admin Tools.
2.Click Change Password.
3.Enter your current password.
4.Enter your new password. It can be alphanumeric and it must be at least 6 characters.
5.Re-enter your new password to confirm it.
6.Click OK.
22
NOTE: If you forget your password, you must ask the AccuWin Pro™ 4 administrator to reset it.
Changing the Current User
To change the current user:
1.From the Configure menu, select Admin Tools.
2.Click Change User.
3.Enter a valid user name.
4.Enter a valid password.
5.Click Login.
6.
AccuWin ProTM 4
Layout
AccuWin Pro™ 4 gives you the flexibility to program the ABP monitor the way you want and the simplicity to collect and
retrieve important test data. The toolbar provides easy, one-click access to frequently used functions. The menu bar allows
you to access all functions of the software.
Toolbar Buttons
Program: Opens the Program Monitor window
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
Settings: Opens the Configuration options window
Help: Opens the online help window
Exit: Closes AccuWin Pro™ 4
23
7.
Conducting an Ambulatory
Blood Pressure Study
Programming The Oscar 2 for an ABP Study
Preparing the monitor for an ABP study involves filling out an on-screen form to set the parameters for your study to
be programmed into the monitor. You can also use a template to fill out the form. Templates help to ensure consistent
programming and adherence to specific protocols. AccuWin Pro™ 4 provides default templates, or you can create your own.
See also Default Templates.
To program the monitor:
24
1.From the Monitor menu, select Program study.
Alternatively, click the Program button on the toolbar.
2.Enter the desired parameter settings in the form (Figure 3).
(See Parameter settings.)
3.Click one of the following:
• Program to transfer the information to the Oscar 2.
An indicator bar shows the progress and disappears when
programming is successfully completed.
• Cancel to close the dialog box.
• Help to start the online Help.
Figure 3: Programming the Oscar 2 (Standard Tab)
To create patient details before conducting a study:
1.In the Program Monitor window, click the button for Select/
Create Patient, Next, click Create New Patient.
2.A new window Patient Information (Figure 4) will appear. Enter
patient information.
3.Click OK to save the patient information to be used on this
programmed study. Click Cancel to close the dialog box.
To add measurement periods:
1. Click the box for Add More.
2. Select a start time, an end time, and intervals from the pull-down
menus, and then click Add. You can add up to twenty-four (24)
additional time periods. A pie chart shows the time periods created
for the study.
3. Clicking Remove Last will delete the preceding time period from
the list.
25
To program the monitor using a template:
Figure 4: Programming the Oscar 2
(Patient Information Window)
1.From the open Program Monitor window, click Open in the upper right-hand corner.
2.From the Available Templates dialog box (Figure 5), select the template name, and then click Open. The form
automatically populates with the template's settings.
3.Click one of the following:
• Program to transfer the information to the Oscar 2. An indicator bar shows the progress and disappears when
programming is successfully completed.
• Cancel to close the dialog box.
• Help to start the online Help
To create a template:
1.In the open Program Monitor window, enter the desired
parameter settings in the form. See Parameter settings.
2.Click Save in the upper right-hand corner.
3.In the Assign Template Name dialog box, type a name
for the template and click Save.
To open a template:
26
1.From the open Program Monitor window, click Open in the
upper right-hand corner.
2.From the Available Templates dialog box, select the
template name, and then click Open.
3.The template information will populate the corresponding
information in the Program Monitor window.
Figure 5: Available Templates Window
To delete a template:
1.From the open Program Monitor window, click Open in the upper right-hand corner.
2.From the Available Templates dialog box, select the template name, and then click Delete.
3.At the prompt, click Yes to confirm deletion.
To email a template:
1.From the File menu, select Email>Programming Template.
2.The Programming Templates window opens. Select the template(s) you want to email and click OK.
3.The Email dialog box will appear. Type in the recipient email address(es), a subject for your message, and a message.
4.Click Send to email the files. Click Attach to change the files you want to email. Click Configure to configure the
email settings.
Parameter Settings
The parameters can be adjusted as follows:
Standard Tab
Patient name, Patient ID
Enter patient name (first, middle, last) and patient ID for reporting and referencing data.
Arm measured
Select Left or Right, and check Dominant, if applicable.
Site number
Enter up to 12 numeric characters.
Study number
Enter up to 12 alphanumeric characters.
Patient Information
Click to open the Patient Information window. Use this window to enter all patient information prior to
conducting the ABP study.
Period:
Specifies when and how often the monitor takes readings. For Awake time and Sleep time, select from
the Hour pull-down menu to establish the start time for these periods. From the Brachial BP Interval and
Central BP Interval pull-down menus, select the desired interval between readings (5, 10, 15, 20, 30,
45, 60, 90 or 120 minutes). Please note that the available option for Central BP Intervals will only be
multiples of the selected Brachial BP Interval.
Start study in 5
minutes:
Check denotes that the study will start automatically after programming; unchecked denotes that the study will
be started with the first press of the Start/Stop button when the monitor is powered ON.
Advanced Tab
Max Pressure
Establishes the maximum inflation pressure for the monitor (options between 160 and 280 mmHg). Suggested
setting is 30 mmHg above the highest expected systolic BP.
NOTE: The ABP monitor will not inflate to Max Pressure with each reading; instead it inflates to 30 mmHg
above the previous systolic reading.
Intervals
Set interval type. Select Fixed to set the intervals to exact times. Select Standard for +/- 5 minutes around
the selected intervals.
Minimum time
between readings
(min)
Allows adjustment of the length of the minimum time lapse between measurements. The number of minutes
entered must be smaller than the shortest selected brachial BP interval.
Retry attempts
When on, the monitor reattempts a measurement that initially fails.
27
28
Manual readings
When on, allows the patient to take measurements outside of the scheduled program using the Start/Stop key.
NOTE: Manual Readings is always ON for the first 30 minutes of the study.
Type
Select the type of manual reading the patient can take: Brachial BP Only or Brachial BP w/ Central BP.
Audible alerts
When on, an alert sounds at the beginning and upon completion of each reading, during the awake period only.
Event marking
When enabled, allows the patient to signal up to 30 events during the study.
NOTE: If Event Marking is on, Dose Response Sequences is unavailable.
Day/night button
When on, enables the Day/Night button on the monitor, allowing the patient to start the Awake and Sleep
periods according to their daily schedule. A period can be started up to four hours before the programmed
period begins.
Display results
When on, allows the patient to view the results immediately after a measurement.
NOTE: Display Results is always on for the first 30 minutes of study. Only brachial BP results will be displayed.
Note 1, Note 2
Enter up to 20 alphanumeric characters.
Time zone difference
Adjust the monitor’s clock to the time zone that the patient is in relative to your time zone. (The PC Time and
Monitor Time fields are populated automatically.)
Dose Response
Sequences
Specify the duration, brachial BP interval, and CBP interval for up to four dose response sequences. These
sequences are useful for tracking BP after a drug dosage is administered. A sequence begins when the patient
presses the Event button. To clear fields, click Reset.
NOTE: If Event Marking is on, Dose Response Sequences is unavailable.
Quality Control Tab
QC Review Period:
Select start and end times for a quality control review period for the study program.
Minimum Reading
Requirements:
Enter the requirements for a minimum percentage of scheduled readings captured during the defined QC
period.
The minimum number of readings captured per hour during the defined QC period (between zero and 12).
The minimum number of hours to contain readings for the entire study.
NOTE: To access the Quality Control tab you must first check the “Add Quality Control?” checkbox at the top
of the Program Monitor window.
Fitting a Patient with the Oscar 2 and SunTech ABPM Cuff
After you have successfully programmed the Oscar 2 using AccuWin Pro™ 4, you may begin fitting the patient with the
monitor and a blood pressure cuff. Cuffs may be used on either arm.
1. Choose the proper cuff size
To determine the correct cuff size for your patient, wrap the cuff around the patient’s upper arm without sliding the arm
through the sleeve. Use the color- coded RANGE indicator on the inside of the cuff and the bold INDEX marker to check
that the arm circumference falls within the cuff range. If the arm is within range, this cuff size is correct for your patient. If the
marker is outside the RANGE indicator, select a new cuff size as indicated by color.
CAUTION: Using an incorrect cuff size could result in erroneous and misleading blood pressure
measurements.
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2. Apply the SunTech ABPM cuff
To apply the SunTech ABPM cuff,
simply slide the sleeve up the
patient’s arm, ensuring the color
size indicator is at the top of the
cuff. The cuff should be midway
between the elbow and shoulder.
Be sure the ARTERY indicator is
over the patient’s brachial artery,
between the bicep and tricep
muscles. Wrap the cuff snugly
around the patient’s upper arm.
Figure 6: Instructions for Applying the SunTech ABPM Cuff
3. Connect the hoses
Connect the hoses from the cuff and monitor
by twisting the fittings together until you hear
a snap. Drape the hose over the patient’s
shoulder, behind the neck and across to the
opposite side of the body.
4. Attach to patient
Insert the Oscar 2 into its pouch with the display
showing through the window. Attach the pouch
to the patient using the belt (Figure 7).
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Figure 7: Fitting the ABPM Cuff to the Patient
Preparing And Educating The Patient
When conducting blood pressure measurements, with an oscillometric NIBP device, it is important to follow suitable
procedures to ensure valid, accurate results. Preparing your patient for the ABP study is the most important step to achieving
a successful test. Review the following instructions with your patient.
• When the pressure in the cuff increases, the patient should avoid excess movement during measurements. Let the cuffed
arm hang loosely, slightly away from the body with the middle of the cuff at heart level. Avoid flexing the muscles or
moving the hand and fingers of the cuffed arm.
• The patient can stop a measurement in progress by pressing the Start/Stop button.
• If the Manual Readings setting is on, the patient can start a measurement at any time by pressing the Start/Stop button.
• The cuff should not be removed between BP measurements.
• Before sleeping, the patient should make sure that the hose is not and will not become kinked.
• The batteries can be replaced during a study without the data being lost or interrupting the monitor’s program.
Alternatively, the monitor can be turned off without losing its data.
• Instruct the patient on how and when to fill out the patient diary.
• If Dose Response Sequences are set up, instruct the patient on how and when to start a sequence.
• If the Day/Night button is on, instruct the patient on how to set day and night modes.
• If Event Marking is on, instruct the patient on how and when to mark events.
• Ensure the patient knows how to care for the monitor. Keep the monitor dry and do not drop it.
• If the monitor or cuff causes extreme pain, or pain not normally associated with blood pressure measurement, the
patient should remove the cuff and turn off the monitor.
• The patient should not talk during BP measurements. The patient should be seated, standing or lying down. If seated,
the patient should have legs uncrossed, feet flat on the floor with back and arms supported.
Starting the Study
Before the patient leaves with the monitor and cuff, verify that the monitor operates correctly. To verify proper monitor
operation, ensure that the monitor is on and start a BP reading by pressing the Start/Stop button. The cuff will inflate and
complete the brachial BP measurement. If CBP measurement has been programmed, before the cuff is fully deflated, the
monitor will hold pressure in the cuff for ten seconds to capture the waveform data required to derive CBP values. The cuff
will then be fully deflated. The clock icon should appear on the display of the Oscar 2 indicating that the study is in progress.
If problems occur, review the setup and fitting of the system.
Replace the batteries (2 AA’s) for every study with new, high-quality batteries. Failure to do so may result in incomplete 24hour studies.
To record an event:
• Press the Event button.
The monitor sounds a long audible beep for confirmation, and "rcd : 01" appears on the display (Subsequent recordings use
02, 03, and so on). The monitor can record up to 30 events. If the patient tries to record more than 30 events, the monitor
beeps four times, and "No rcd" appears on the display.
Note: If Event Marking is enabled, then the Dosage Response feature will be disabled.
31
To start a dose response sequence:
• Press the Event button.
The monitor sounds an audible beep for confirmation and begins the first reading in the sequence. The Event button is
disabled until all readings in the sequence are complete.
Note: If Dosage Response is enabled, then the Event Marking feature will be disabled.
To manually set day (Awake) or night (Asleep) mode:
• Press the Day/Night button.
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The monitor beeps and displays either the sun or moon icon depending on the mode that it was switched to.
If switching to Night mode, the monitor will display a moon icon.
If switching to Day mode, the monitor will display a sun icon.
Finishing the Study
If you wish to finish the study before the patient returns, instruct the patient to turn off the monitor by holding down the Start/
Stop button for five (5) seconds. The Oscar 2 will beep five (5) times and the display will turn off.
When the patient returns, take the cuff, monitor, and belt off and download the captured data to AccuWin Pro™ 4 for review.
8.
Notes on Blood
Pressure Data
Any blood pressure reading can be affected by the measurement site, the position of the patient, motion, or the patient’s
physiologic condition. Environmental or operational factors which can affect the performance of the device and/or its blood
pressure reading are common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis,
poor perfusion, diabetes, age, pregnancy, preeclampsia, renal diseases, patient motion, trembling, and shivering
Retrieving Data from the ABP Monitor
To retrieve the data:
1.Connect the Oscar 2 to the computer.
2.In AccuWin Pro™ 4, click the Retrieve toolbar button, or select Retrieve Data from the Monitor menu. The dialog box
on the screen shows the progress as the data is transferred. After completion, a dialog box appears to confirm patient details.
3.In the dialog box, do one of the following:
• Click No. A list of current patient files appears. Select the patient file to save the retrieved data.
• Click Yes. The Patient information dialog box appears. Enter patient information in the data fields
4.Click OK to save the data.
5.If the alert for adjusting Awake and Asleep times appears, click Yes or No according to your preference.
6.If the study contains quality control settings, review the results in the Quality Control Results dialog box that
appears, and then click Close.
NOTE: A green checkmark in the results indicates that the study meets that requirement. A red x indicates that the study failed to meet
that requirement.
The BP file will now open automatically and the patient’s BP data is now saved to the AccuWin Pro™ 4 patient database.
CAUTION: If you do not retrieve data from the monitor, this data will be lost when you program it for the next study.
33
9.
Reviewing and
Editing an ABP Study
Opening A Patient File
AccuWin Pro™ 4 will automatically open a patient file directly after the data is retrieved.
34
1.From the File menu, select Open. Alternatively, from the toolbar, click the BP Data button.
2.The Open ABP Study - Select Patient dialog box appears, allowing you to select the patient file to open. Select the
patient whose BP data you wish to retrieve by clicking on the patient’s name.
3.Click OK.
4.If the patient has more than one ABP study, a second dialog box, Choose Date, appears. Select a study date and click
OK. The patient’s data appears in the display area. You can now review the BP study or print a report.
Each study in a patient file contains data that is displayed in the views accessed by the tabs at the bottom of the application.
The study information bar located toward the top of the view identifies the patient name, patient ID, patient age (at the time
of the study) and the study date of the displayed file.
Tabs and their contents
•ABP Data: ABP measurement data from the monitor and relevant graphs.
•Patient Info: Patient name, ID, contact information, and physical description.
•Physician Info: Patient history, clinical information, and interpretation.
•Statistics: Statistical analysis of the ABP study.
•Dose Response Statistics: Statistical analysis for dose response sequences.
•Time-Slice Statistics: Statistical analysis of specific user-defined time windows.
•Hourly Averages: Analysis of ABP study data including study comparison.
•Summary: Interpretative summary settings and results for current study.
Viewing An Ambulatory Blood Pressure Study
In the upper portion of the ABP Data tab, a table displays the results for each of the BP measurements taken or attempted
during the study. The table also includes events recorded by the patient and dose response sequences. To display only these
events in the table, select Events Only from the Show pull-down menu. Events and Readings displays all records.
Below the table are three tabs offering different graphical representations of the BP data: Overview Graph, Central BP Data,
or AASI Graph.
35
Figure 8: ABP Data Graph, Threshold tab
To adjust the size of the data table:
1.Position the mouse pointer over the bottom boundary of the table.
2.When the pointer turns to a double arrow, drag it up or down.
Overview Graph
The scale of the vertical axis represents blood pressure (mmHg) and heart rate (bpm). The horizontal axis displays the time in
clock hours. Clicking on any point, measurement or event, in the graph highlights the corresponding row in the table.
There are three tabs to the right of the graph: Threshold, Time-Slice, and Legend. The Threshold tab allows the user to
change the Threshold settings on the graph. The Time-Slice tab allows users to define specific time windows in which to
perform a statistical analysis. The Legend tab provides details on the configuration of colors for the Overview Graph.
Shading on the graph indicates various periods of the study. The default colors (see Display Settings) and definitions are:
36
•Blue shading: Indicates the asleep period of the study.
•Yellow shading: Indicates the white coat period, which is the first hour of the study (appears only if enabled).
•Light green shading: Indicates a dose response period (appears only if programmed).
•Light teal shading: Indicates the periods used to calculate Morning Surge (appears only if enabled).
Central BP Data
The Central BP Data tab provides a detailed view of individual CBP measurements taken during the study. If your Oscar 2 is
configured with the SphygmoCor Inside technology, you will be able to collect, display, and analyze these parameters. The
tab will display the number, time and date of the selected reading along with the following:
Average Central Pressure Waveform: A graphical representation of the derived average central pressure waveform.
The shape of the aortic pressure pulse is a result of the ventricular ejection and physical properties of the arterial system. The
waveform shape changes with changes in arterial stiffness.
Central Systolic Pressure (cSYS): The maximum pressure during aortic ejection. High cSYS indicates high
cardiovascular load. High arterial stiffness increases the reflected pressure wave in the arterial system, and augments
or increases cSYS pressure. With aging, the arteries become stiffer. Consequently, wave reflection increases, leading to
increased cSYS and resulting in increased risk of cardiovascular disease or organ damage.
Central Diastolic Pressure (cDIA): The minimum pressure during aortic ejection.
Central Pulse Pressure (cPP): Represents the height of the aortic pressure waveform. cPP can also be described as the
difference between the maximum and minimum of the central pressure waveform, or cSYS minus cDIA. Aortic cPP greater
than 50 mmHg has been shown to predict cardiovascular disease.
Central Augmention Pressure (cAP): cAP is a measure of the pressure wave reflected back from lower body. It is
calculated as the difference between the two pressure peaks during ejection (systole). The first peak is related to cardiac
ejection and the second peak is related to wave reflection due to arterial stiffness. The cAP value is affected by both the
magnitude and speed of the reflected wave, which is an indicator of arterial stiffness.
Central Augmentation Index (cAIx, cAIx@75): The ratio of cAP to cPP, expressed as a percentage. Studies have
shown that patients with diabetes tend to have high cAIx, indicating stiffer arteries and higher risk of organ damage. cAIx is
also corrected for a heart rate of 75 beats per minute.
Measured Brachial Waveform: A graphical representation of the brachial waveform captured during the displayed
measurement. The brachial waveform data is used to derive the average central pressure waveform.
The Central BP Data tab also offers the user the option to print or save the details for any single CBP measurement from the
study. The printed page or saved file will be a single page document containing the same information as is presented on the
Central BP Data tab for the selected measurement along with the patient name, patient ID, study date, brachial systolic and
diastolic values, and heart rate.
The following diagram shows the central aortic pressure waveform.
37
160
Augmented
Pressure (AP)
Systolic
Pressure (SP)
150
Augmentation Index
AIx = (AP/PP)x100%
140
130
mmHg
Pulse
Pressure (PP)
120
Systolic
110
Diastolic
100
90
38
Diastolic
Pressure (DP)
0
100
200 300
Ejection
Duration (ED)
400
500
600
700 800
Time (ms)
Figure 9: Explanation of Central Blood Pressure Waveform Characteristics
AASI Graph
The AASI Graph tab is optional, and can be enabled by selecting Ambulatory Arterial Stiffness Index on the
Report>Configuration>Data (see Customizing and Configuring AccuWin Pro™ 4). The graph on this tab plots the
diastolic on systolic BP values for each measurement captured in the study. Additionally, this tab lists the calculated AASI
value, diastolic as a function of systolic, systolic as a function of diastolic, the correlation coefficient of the linear regression
equation, and the coordinate of the average systolic and diastolic. The calculated AASI value will also be added to the
Overall results on the Statistics tab. The user can specify which BP values to use in the graph and calculations by selecting
Brachial BP Values or Central BP Values near the bottom of the legend.
Figure 10: AASI Graph
Reviewing an Ambulatory Blood Pressure Study
In the ABP Data view, you can review an ABP study for accuracy and context. When the data is retrieved by AccuWin Pro™
4, all readings in an ABP study that have event codes will be “tagged” in the first column of the table. Tagged records are
omitted from the analysis of the ABP study displayed in the Statistics and Hourly Averages views, but these readings can be
printed in the report.
The monitor tags data with an asterisk based on criteria used to determine the validity of the data. The exclamation point
(!) is a permanent tag and is used when an accurate reading cannot be determined by the ABP monitor. This tag cannot be
changed and associated data will not be used in data analysis. The asterisk (*) is a tag that you can edit. Tags numbered r01
to r30 indicate events entered by the patient, and the comments can be changed. Data can be tagged or un-tagged based
on a number of factors, including patient history, patient diary information, or other factors.
39
There are two methods to remove or insert an asterisk (*) tag on a measurement.
To remove or insert an asterisk (*) tag using the table:
1.Select the reading you want to tag (omit) or un-tag (include). It will be highlighted.
2.Click in the first, or left-most, cell under the column labeled “Tag”.
To remove or insert an asterisk (*) tag from the graph:
1.Use the cursor on the graph to select the reading you want to tag (omit) or un-tag (include). Consequently, this action
highlights the reading in the table.
2.Right-click the mouse and select Toggle Tag from the menu.
NOTE: All changes made to the ABP study are saved immediately.
40
Entering Comments
Use the Comments column, the right-most column in the table, to keep track of patient activity during a BP reading. While
activity is only one of the many factors that can affect blood pressure, it can be helpful in understanding a BP reading within
the context of the study.
To assist the patient with tracking their activities, a patient diary template is available for printing
from the Download Library on the SunTech Medical website.
To enter a patient comment from the table:
1.Highlight the reading to which you want to add a comment, and select the corresponding cell
in the Comments column.
2.Left-click the mouse over the comment box to open the pull-down menu of predefined entries.
3.Select a comment from the list or type a new comment.
4.Press Enter.
Figure 11: Diary Comment
Drop-Down Selection Box
To enter a comment from the graph:
1.Select the reading in the ABP data graph to which you want
to add a comment. This causes the corresponding row in the
table to be highlighted.
2.Right-click the mouse and select Set comment from the
menu.
3.Add a comment by typing or selecting from predefined list.
4.Click OK.
Figure 12: Text Entry Box for Setting a New Comment
You can add or delete entries appearing in the Comments pull-down list by going to the Diary Comments section of the
Configuration window. (For instructions on configuring Diary Comments, see Customizing and Configuring AccuWin Pro™ 4.)
To change the comment for an event marked by the patient:
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Click the event's checkmark above the graph to cycle through the following
selections (symbol: comment):
: "Event marked"
Rx: "Dosage"
Sx: "Symptom"
The selected symbol replaces the checkmark, and the comment appears in the
table.
Changing Awake/Asleep Times
Along with BP thresholds, asleep times are used to calculate BP loads and
asleep dip percentage. The time is defined by the parameters set when preparing
the monitor for a study or by the patient manually setting day and night modes.
However, you can change these times if they have not been pre-defined or
are inaccurate.
Figure 13: Edit Awake/Asleep Times
To change time period start times:
1.Display an ABP study and choose the Threshold tab.
2.Click Edit Awake/Asleep Times.
3.In the Times tab (Figure 12), reset the patient’s asleep and awake times to the nearest half-hour by moving the
appropriate sliders right or left. The new times are displayed on the clock face, with the black portion representing time
asleep and the white portion, time awake. The clock is displayed in military time (i.e. 12:00 is noon, 18:00 is 6 p.m.,
and 00:00 or 24:00 is midnight).
4.Click Apply to keep the new settings.
Setting BP Threshold Limits
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Users may select the thresholds used to calculate the blood pressure load and above threshold values for brachial and
central BP parameters. There are two settings for thresholds: global and custom. Global thresholds apply to all patient files;
custom thresholds apply to all studies for a particular patient.
To define thresholds:
1.Open a study in the ABP Data tab. Within the Overview Graph tab, navigate
to the Threshold tab located to the right of the graph view.
2.Click Edit Thresholds.
3.From either the Brachial Thresholds or Central Thresholds tab, click Use custom
or Use global thresholds.
4.Move the sliders to change the settings according to your preferences.
5.Click OK to apply the changes.
Figure 14: Setting BP Thresholds
Brachial Thresholds
Brachial thresholds can be set for Awake and Asleep systolic and diastolic BP. The default setting is a global threshold set
to 140/90 mmHg for Awake periods and 120/80 mmHg for Asleep periods. If desired, you can set thresholds to match a
published standard using the corresponding buttons: JNC7/AHA or ESH.
• JNC79 recommends 135/85 mmHg for Awake periods and 120/75 mmHg for Asleep periods.
• The American Heart Association (AHA)10 recommends a 24-hour average BP of 130/80 mmHg.
• The ESH11 recommends 135/85 mmHg for Awake periods and 120/70 mmHg for Asleep periods.
Central Thresholds
Central thresholds can be set for Awake and Asleep central systolic BP (cSYS), central pulse pressure (cPP), augmented
pressure (cAP), and augmentation index (cAIx). The default setting for the Awake thresholds is a global threshold set to
calculated values dependent on gender and age of the patient. If no gender or age is provided, the default values will be set
to 130 mmHg for central systolic BP and 50 mmHg for central pulse pressure. No settings will be established for augmented
pressure or augmentation index. There is also the option to set the central pulse pressure (cPP) according to the published
STRONG standard, 50 mmHg.
The default setting for the Asleep thresholds is no selected values. The user does have the option of automatically setting
Asleep thresholds to match the selected Awake values. If no Asleep thresholds are defined, all graphical representations and
related statistics will be left blank.
Setting Pediatric Threshold Limits
The American Heart Association has a published statement supporting ABP monitoring in children, as hypertension is being
diagnosed with increasing frequency in pediatric patients.10 The guidelines for hypertension differ from those for adults;
hypertension in pediatric patients is generally defined as a blood pressure values above the 95th percentile for that gender
and height. Specific ABPM thresholds based on published recommendations are programmed into AccuWin Pro™ 4.12,13,14
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To apply a pediatric threshold:
1. Open a study in the ABP Data tab. Within the Overview
Graph tab, navigate to the Threshold tab located to the right
of the graph view.
2. Click Pediatric Thresholds.
3. Enter the patient’s gender and height. The height may be
entered in centimeters (cm), inches, or feet/ inches. (Figure 15)
4. Select which reference table to use, either Wuhl, et al
(2002) or Soergel, et al (1997).
5. Click Apply
NOTE: The pediatric threshold is applied as a custom brachial BP
threshold, which applies to a single patient’s file.
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Defining Time-Slice Periods
Figure 15: Pediatric Threshold Calculator
Users may define up to twelve specific time windows for which to perform a statistical analysis. The statistical analysis
corresponding to time-slice periods will appear in the Time-Slice Statistics tab to the right of the Statistics tab.
To create a time-slice:
1.Open a study in the ABP Data tab. Within the Overview Graph tab, navigate to the Time-Slice tab located to the
right of the graph view. (Figure 16).
2.Click the New button. On the graph left-click and hold the mouse to select the starting time of the time-slice period
then drag the mouse to the end time. Releasing the mouse button determines the ending time of the time slice. The
selected time-slice will be highlighted on the Overview graph.
3.Once the time-slice is selected, a Time-Slice Settings box (Figure 17) will appear and allow the user to name the timeslice and edit the start and end times, if necessary.
4.Click Save to create the new time-slice.
To edit a time-slice:
1.Open an ABP study and click the Time- Slice tab (Figure 16).
2.Choose the time-slice from the drop-down menu. The time-slice period will be highlighted on the Overview graph.
3.Click Edit. The Time-Slice Settings box (Figure 17) will appear.
4.Edit the name or the start and end times.
5.Click Save to save the settings.
45
Figure 16: ABP Data Graph, Time-Slice tab
Figure 17: Time-Slice Settings Window
To delete a time-slice:
1.Display the ABP study. Choose the Time-Slice tab.
2.Choose a time-slice from the drop-down menu. The time-slice
period will be highlighted on the ABP data graph.
3.Choose Delete. Click Yes to delete the time-slice (Fig. 18).
Figure 18: Deleting Time Slice (Confirmation Window)
Editing Patient Info and Physician Info
Patient and physician information may be entered when data is retrieved from the monitor or after the patient file is saved.
To edit Patient Info (Fig. 19):
46
1.Click the Patient Info tab at the
bottom of the screen.
2.Click on the Edit button at the bottom
of the screen.
3.Update any patient information and
click Save. Alternatively, you may click
Cancel to discard all changes.
Figure 19: Patient Info Tab
To edit Physician Info (Fig. 20):
1.Click the Physician Info tab at the bottom of the
screen.
2.Click on the Edit button.
3.Update any information and click Save. Alternatively, you
may click Cancel to discard all changes.
Users are able to enter and edit Patient History, Reason for
Test, Current Medications, and Physican Interpretation. As an
alternative to typing in the free text field for Current Medications,
users may add Medication, Dosage, and Frequency to
dictionaries that are stored within AccuWin Pro™ 4.
To Add Medications (Fig. 21):
1.Type a medication into the drop-down titled Medication. (See Fig. 22 for
abbreviations)
2.Once the medication is typed, press Enter or Tab on the keyboard or use your
mouse to move the cursor to the Dosage column.
3.Enter Dosage and Frequency in the same manner. Predefined entries in the
Frequency column are listed below.
4.Once the Medication, Dosage, and Frequency are entered into their respective
columns, click the Add button to add the information to the Current
Medications field above and to the dictionary.
Figure 21: Add Medications Menu
Figure 20: Physician Info Tab
Abbreviation
Meaning
ac
Before meals
bid
Twice daily
pc
After meals
prn
As needed
qam
Every day before noon
qd
Every day
qh
Every hour
qhs
Every night at bedtime
qid
Four times a day
qod
Every other day
qpm
Every day after noon
qwk
Every week
tid
Three times a day
Figure 22: Medication Entry Abbreviation Table
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To locate and choose a previously stored entry:
1.Either start to type an entry or choose the down arrow with your mouse. As more characters of the desired entry are
typed, a list of matching entries will be displayed.
2.To choose the stored entry, use the down arrow on the keyboard, highlight the desired entry, and press Enter on the
keyboard. Alternatively, use the mouse to highlight the entry, and then double-click the entry.
3.When each of the columns are populated with the correct information, click Add.
Viewing Statistics
To view the statistical analysis for the displayed ABP study, click on the Statistics tab. This window initially shows the following
tables:
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•Overall: Data for the complete ABPM study
•Awake Period: Data collected while the patient is awake
•Asleep Period: Data collected while the patient is asleep
•White Coat Period: Data collected during the first hour (if enabled).
The Statistics tab can also show additional time periods or BP load charts.
To show additional time periods or BP load charts:
Under Show, select one of the following:
Additional Time Periods to show tables with data collected during other time periods, as programmed.
BP Load Charts to show pie charts for the Overall, Awake, and Asleep periods, illustrating values above and below
established thresholds for brachial and central systolic BP, and brachial diastolic BP.
NOTE: All data in these tables is included in exports, except white coat analysis values and BP load charts.
In the Statistics tab, each table includes the mean, standard deviation, coefficient of variation (CV), minimum value, and
maximum value for the following parameters: brachial and central systolic, brachial and central diastolic, brachial and
central MAP, brachial and central pulse pressure, central augmentation index, central augmentation index at 75 bpm, and
central augmentation pressure.
Additionally, the following calculations are also provided on the Statistics tab:
• BP Load: Blood pressure load characterizes the distribution of measurements in an ABPM study relative to brachial
systolic and diastolic thresholds indicative of hypertension. The percentage of readings above this threshold is the BP
load which has been shown to predict target organ involvement. 14
• Asleep Dip: The nocturnal fall of blood pressure expressed as a percentage of the mean awake values. The expected
nocturnal dip for brachial BP is 10-20%. The absence of the expected dip may indicate end-organ damage or risk for
cardiovascular events.7,16
The Statistics tab may include any of the following additional calculations if they are enabled under
Report>Configuration>Data>:
• Ambulatory Arterial Stiffness Index (AASI): AASI is calculated as one minus the regression slope of the diastolic
on systolic blood pressure. (The regression slope is calculated by plotting the diastolic against the systolic values.)
This index has been used to measure arterial stiffness and has been shown to help predict target organ damage,
cardiovascular mortality, and stroke.17 The user can specify which BP values to use when calculating this value by
selecting Brachial BP Values or Central BP Values from the AASI Graph tab.
• Morning Surge: Morning Surge is calculated as the difference between the mean systolic BP during the two hours
after waking, minus the systolic BP during the Asleep hour containing the lowest BP value measured. This calculation
can help to identify cases in which the morning BP increase is unusually high and presents a potential cardiovascular
risk or a risk of stroke.14
• Coefficient of Variation: The Coefficient of Variation (CV) can be used as a measure of BP variability, which can be
a determinant of end-organ damage.18 CV is calculated as the standard deviation divided by the mean blood pressure
of a time period.
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• Smoothness Index: Smoothness Index (SI) is the ratio between the average of the blood pressure changes
computed for each hour of the recording and its standard deviation. SI is generally used to evaluate the effectiveness of
antihypertensive treatment as it shows the averaged trend of blood pressure reduction between two studies.19
• White Coat Analysis15: White coat syndrome refers to abnormally elevated blood pressure when the patient is in a
medical setting. If selected, this option does the following:
• Adds a white coat period to the statistical analysis.
• Displays the first hour of the study, or white coat period, with a light blue background in the graphs.
• Evaluates for and reports on the presence of white coat syndrome on the interpretive summary, when present.
NOTE: Either brachial or central BP values can be used to calculate Morning Surge, Coefficient of Variation, and Smoothness Index. To
specify which blood pressure values to use, see Data Settings.
Viewing Dose Response Statistics
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To view the statistical analysis for dose response sequences, click on the Dose Response Statistics tab. This tab is present
only when dose response sequences have been recorded. You can specify which sequence to display by selecting its number
from the Show Sequence menu. The window shows seven scatter
plots for ten parameters measured within the dosage response
sequence. Results are also provided for BP load and maximum
change from the baseline (the first reading of the sequence)
for the systolic (SYS), diastolic (DIA), and central systolic (cSYS)
parameters.
Figure 23: Time-Slice Statistics
Viewing Time-Slice Statistics
To view the statistical analysis for user defined time-slice periods, click on the Time- Slice Statistics tab (Figure 23).
Viewing Hourly Averages
To display trends in a patient’s ABP study, click the Hourly Averages tab at the bottom of the window (Figure 24). The table
shows the average BP readings for each hour the patient was tested. In addition to brachial systolic (SYS) and diastolic (DIA),
and the heart rate (HR), the following statistical averages are provided:
• Mean Arterial Pressure (MAP) - This is the average pressure
in an artery over the period of one heartbeat. In the brachial
artery, it is calculated by adding the diastolic to one-third of
the difference between the systolic and diastolic readings.
• Pulse Pressure (PP) - This is calculated by subtracting
the diastolic from the systolic reading. It is another
hemodynamic parameter that may serve as an indicator for
cardiovascular risk. Pulse pressure is provided using both
brachial (PP) and central (cPP) values.
• Pressure Rate Product (PRP) - This is the product of the
average systolic reading multiplied by the average heart
rate. PRP strongly correlates to a patient’s activity level and
may be a key indicator of cardiovascular risk. As typically
reported in research and clinical applications, PRP data is divided by 1000.
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Figure 24: Hourly Averages
Use the check boxes at the top of each column to select the statistics you would like to see displayed in the graph at the
bottom of the page. You can resize the table and zoom in on the graph with your mouse pointer. (For instructions on resizing
and zooming, see Viewing an Ambulatory Blood Pressure Study.)
Viewing the Interpretive Report Summary
This window (Fig. 25) shows an interpretation of the ABPM data
based on published guidelines. Because traditional BP guidelines
might not apply to the 24-hour ABPM readings, AccuWin Pro™
4 includes the recommendations specifically for evaluation of
ABPM levels. The summary provides normal or hypertensive
results for the 24-hour average, awake, and asleep systolic and
diastolic pressure readings, asleep “dipping” status, and an
optional white coat analysis.
52
To generate an interpretive summary for the displayed ABP study,
click the Summary tab on the bottom of the screen and select one
of the following options for interpretation:
Figure 25: Summary Tab
• Joint National Committee Seventh Report (JNC 7)7 and American Heart Association (AHA)8 guidelines.
• European Society for Hypertension
• (ESH)6.
• Pediatric – AHA12
• Pediatric – Soergel Tables11
Based on the calculated brachial dip percentage, AccuWin Pro™ 4 determines whether the patient is one of the following:
• Dipper (normal): A patient shows a decrease of 10% or more in brachial systolic or diastolic blood pressure values
during sleep compared to readings taken when awake.
• Non-dipper (abnormal): A patient shows no decrease or less than a 10% decrease in brachial systolic or diastolic blood
pressure values during sleep compared to readings taken when awake.
Comparing Two Studies
To further enhance the utility of ABPM, you may want to measure the progress of a patient’s blood pressure by conducting
multiple studies. AccuWin Pro™ 4 allows for the comparison of the hourly averages and statistics for two studies conducted
on the same patient.
To compare two studies:
1.Click on the Hourly Averages tab at the bottom of the window.
2.Click on the Get Comparison Study button. (If the button is grayed out, the patient file you are viewing contains only
one study.)
3.The Choose Date window will appear. Select the study you want to use as a reference for comparison by highlighting
it and clicking OK.
The statistics generated during the previous study are now incorporated into the Hourly Averages window. The table expands
to include the hourly average values for the reference study, and the differences between the displayed and the reference
studies.
On the graph at the bottom of the window, both studies’ data are displayed. The dotted lines represent data from the
reference study, and solid lines represent data from the displayed study. Select Difference and the graph will display one
line representing the difference between the two studies. The same navigation tools for the Hourly Average and ABP Data
windows also apply to the comparison window
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10.
Creating Reports
Configuring and Customizing The Report
To document a study and its findings, you can create a customized report
(Figure 26).
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AccuWin Pro™ 4 provides the following preconfigured report formats:
• One page report: Summary page only.
• Standard report: Summary, Patient Information (all information from the
Physician Info tab), Statistics, ABP Data, and Monitor Configuration pages.
• Full report: All report pages.
NOTE: All report pages include the SunTech Medical logo, patient demographics (all
information from the Patient Info tab), and test date. The footer of each page identifies the
type of monitor used and the page number.
To configure or customize your report (Fig. 26):
1.From the Report menu, select Configure, or click on the Settings button
on the toolbar then navigate to the Report tab in the Configuration window. Figure 26: Configuration Window, Report Formats
2.On the Formats tab, do one of the following:
• Choose one of the formats listed in the left pane. When you select a format, the pages included in that format are
selected in the Report Pages box.
• Create a new custom report format by clicking New Report. Enter the report format name. Select the pages from
the Report Pages list on the right.
3.To include an additional page in your report, click the respective page in the Report Pages box.
4.Under Report Title, enter up to five lines of text that will appear in the header of every report page.
5.Select either a single-page or multi-page view for the Print Preview window on the Details tab (Figure 27).
You can choose from the following pages to customize your report (listed in the order the pages will print, see Figure 26):
• Summary: The Interpretive Summary appears above the data graph and summary statistics. Summary brachial and
peak central BP statistics for the overall, awake, asleep, and white coat (if chosen) periods include: mean systolic and
diastolic, mean heart rate, BP load, and asleep dip.
• Patient Information: Includes patient history, reason for test, patient medications, and the physician interpretation.
• Statistics: Displays detailed statistics for brachial and central BP parameters according to the time periods included
in the study. Overall, awake and asleep time period results will be displayed first, followed by the white coat period (if
enabled), and finally any additional time periods programmed by the user.
• Time-Slice Statistics: Displays statistics for brachial and central BP parameters for each user defined
time-slice period.
• Reviewed Data: Shows all the BP readings captured during the study in table format as it is shown on the ABP Data
tab within AccuWin pro™ 4, excluding the event codes (EC column). The vertical black line between the # and Time
columns indicates the asleep time period. A “>” symbol adjacent to the BP values indicates that it has exceeded
the threshold.
• Omitted Data: Shows the BP readings that were excluded from the statistics calculations. This page appends to the
Reviewed Data page, if printed.
• Events Marked: Shows events marked by the patient during the course of the study. This page appends to the
Reviewed Data page, if printed.
• Dosage Response: Displays the statistics and scatter plots for each of the dosage response sequences captured
during the study, as they are displayed in the Dose Response Statistics tab.
• AASI: Displays the data and graph for the AASI parameter, as they are displayed in the ABP Data>AASI tab.
• BP Load: Shows the BP load pie charts.
• Hourly Averages: Displays hourly average data for the study in graph and table formats, as displayed on the Hourly
Averages tab.
• Study Comparison: Displays study comparison data in graph and table formats, as displayed on the Hourly
Averages tab.
• Histograms: Contains frequency histograms for awake and asleep time periods for brachial and central systolic and
diastolic BP, heart rate, MAP, PRP, and PP.
• Monitor Configuration: Shows the programmed time period, dosage response, and monitor settings for the study.
The page also displays the quality control results for the study (if applicable) and definitions for event codes.
55
To configure report details (Figure 27):
56
1.Click the Details tab. From here you can control the following parameters for
printing reports:
• Overview Graph Type: Select line, bar, or the type of graph currently
displayed according to the type you want to print on the Summary page of the
report.
• Overview Graph Scale: Select time scale for the graph that prints on the
Summary page of the report.
• Summary Page User Fields: Check desired fields for medications, patient
history, test reason, and physician interpretation.
• Horizontal Sight Lines: Select preferred frequency of sight lines in the
Reviewed ABP Data table when printing the Reviewed Data Page, or Omitted
Data Page in the report.
• Report Viewing Options: Select either a Single-page or multi-page view of
the report which will appear in the Print Preview window.
2.Click OK to apply the changes.
Figure 27: Configuration Window,
Report Details
Previewing The Report
1.From the Report menu, select Preview.
Alternatively, click the Print Preview toolbar
button. The Print Preview window is displayed
(Figure 28).
2.To scroll through the report pages, click on the
numbered icons on the left side of the window, or
select the page you want to view using the drop
down menu.
3.To change the format and details, click
Configure.
4.To print the report, click Print Report. To print
the currently viewed page, click Print Page.
Printing The Report
Figure 28: Report Print Preview
AccuWin Pro™ 4 provides you with flexibility in printing the report. You can either:
• Print the configured report by clicking the Print Report button on the toolbar or by going to the Report menu and
selecting Print. The Print dialog box is displayed, where you can choose the preferred printer.
• Print the report page corresponding to the current tab that is being displayed by clicking Print Page.
Saving The Report as a PDF
To save the report as an Adobe Portable Document Format (PDF), from the Report menu, select Create PDF. Alternatively,
click the PDF toolbar button. The system creates the PDF and saves the file to the location you specify.
NOTE: You must have a printer installed. If you do not have a printer installed, see the online Help to install a driver to print to a file.
57
Overview of AccuWinTM 4
Pro Report Symbols
11.
The following symbols are used in the Reviewed and Omitted BP data report pages.
58
Symbol
Explanation
+
Signifies the reading was initiated manually by the patient pressing the Start/Stop key on the monitor.
-
Indicates that the pressure to which the cuff inflated in dynamic inflation mode may have been too low to obtain an accurate
systolic reading. Readings marked with “-” are automatically omitted from the study. Compare the tagged reading with a “-”
to the BP readings above and below it. If the omitted reading seems to be acceptable, un-tag it from the ABP Data tab; if it
does not seem acceptable, leave it “tagged”.
r
Indicates that this reading was a retry reading. Retries are readings that are automatically obtained 4 minutes after a
measurement attempt fails or a questionable reading is obtained by the monitor.
!
The exclamation point is a permanent tag and is used when an accurate reading cannot be determined by the Oscar 2.
>
This symbol will appear to the left of the measurement if the reading results were above the set threshold.
r01 to r30
These numbered tags identify a series of patient-marked events which occurred during the study.
12.
Managing
Patient Studies
Opening a Patient Study
This feature allows you to retrieve and view a patient study.
1.From the toolbar, click the BP Data button or from the File menu, select Open. The Open ABP Study – Select
Patient dialog box appears listing all available patient files.
2.Select the patient whose BP data you wish to retrieve by clicking on the patient’s name. A search bar is available to
locate the patient by any information relevant to the patient’s file. Click OK.
3.If the patient has more than one ABP study, a second dialog box, Choose Date, will be displayed. Select a date and
click OK.
4.The patient’s data appears in the Display Area. You can now review the BP data or print a report.
Exporting a Patient Study
You can export BP data files to ASCII, GDT or XML format. XML can be used to create an HL7 compatible file.
1.From the File menu, select Export.
2.Choose either to export the Displayed File or select files From Database.
3.If exporting files from the database, select the files you want to export and click OK.
4.The Export dialog box appears. Click Export to export the file(s). Click Edit to change the list of files you want to
export. Click Configure to configure the details of the exported file(s). (For instructions on configuring export, see
Export in Customizing and Configuring AccuWin Pro™ 4).
The exported files will be exported to the selected file location as either a *.ASC, *.GDT or *.XML file depending on the
format chosen.
59
Emailing a Patient Study
To email AccuWin Pro™ 4 data files as an attachment:
1.From the File menu, select Email.
2.Choose either to email the Displayed File or select files From Database. If displayed File is chosen, the data
currently displayed on the screen is emailed. If From Database is chosen, the patient database window opens and
prompts you to Select file(s) to email. Check the files you want to email and click OK.
3.The Email dialog box will appear. Type in the recipient email address(es), a subject for your message, and a message.
4.Click Send to email the file(s). Click Attach to change the files you want to email. Click Configure to configure the
email settings. (For instructions on configuring email, see Email in Customizing and Configuring AccuWin Pro™ 4).
Deleting a Patient Record
60
This feature allows you to delete one or more patient records at a time. Each patient record contains ALL ABPM studies for
that patient; therefore ALL ABPM studies for that patient will be deleted when selected.
To Delete Selected Patient Study(s):
1.From the file menu click Patient Management.
2.In the Patient Management window, select the patient(s) that you’d like to delete.
3.Click Delete.
4.A dialog box Select Date may appear. You may select one study date by clicking on it. Alternatively, you may use the
checkboxes to select more than 1 patient file.
5.Click OK to delete the selected study(s). A confirmation window Delete Study will appear. Select Yes to confirm
deletion of selected studies. Click No to cancel and return to the Select Date window.
Importing a Patient Record
You may import patient studies that are saved on your computer, so that the files are stored in the main AccuWin Pro™ 4
patient database.
To import patient studies:
1.Click File then select Import > Import Patient Study.
2.Click Browse Files. A Windows Explorer Window will appear to allow you to select the patient study files that you
would like to import.
3.Select the patient study files that you would like to import. You may select multiple files using standard windows
shortcuts, if you prefer.
4.Click Open. The patient study files will populate in the Import Patient Study window.
5.Click Import. A progress bar will show the status of the import process.
Grouping Patient Records
Grouping patient records can be useful for organizing patient data based on certain demographics, templates, or studies.
To create a new group:
1.Click File then select Group Management.
2.Click Add. A dialog box appears with a text entry box for the new group name.
3.Type the new group name in the text entry box.
4.Click OK.
5.A dialog box appears Group added successfully. Click OK.
61
To move patients between groups:
1.Click File then select Patient Management.
2.Using the checkboxes to the left of the dialog box, select the patients that you would like to manage.
3.Click Move Patient.
4.Select the Group Name using the drop-down menu from the dialog box.
5.Click OK. A confirmation window will appear once the patient(s) have been moved successfully.
62
13.
Customizing and Configuring
AccuWin ProTM 4
It may be helpful to have multiple configuration profiles for your users, for example, one for each physician in the practice.
To create or edit configuration profiles in AccuWin Pro™ 4:
1. From the Configure menu, select Preferences.
2. Create a new profile or edit an existing profile. Click on the name of the profile you want to edit and click Edit. To create
additional profiles, click New, name the profile, click Enter, and then select Edit.
3. Click OK to choose a configuration.
If you are editing a configuration profile, a window opens to display a number of configuration options which are described
in detail on the following pages.
NOTE: On each tab, clicking a Default button returns the settings of that tab to the default factory settings.
63
Hardware Settings
The Hardware Settings window (Figure 29) allows you to configure your
computer to communicate with your ABP monitor via a specified port. You
may also test the settings that you have selected.
1.On the tool bar, click on Monitor, then choose Configuration Port.
1.Under ABP device, select your monitor type.
2.Under Serial port, select the port into which you have plugged
the device.
3.Click Test port. The unit will beep once, and you will receive a
message confirming successful communication.
64
If you receive an error message, “Cannot communicate with ABP device,”
one of the following applies:
• You have not selected the appropriate port or device.
• The device is not connected properly.
Figure 29: Configuration Menu, Hardware
Data Settings
The Data Settings tab (Figure 30) allows you to configure the
following settings:
Data Source: Select how heart rate, Morning Surge, and Smoothness Index
are displayed or calculated (i.e. using brachial or central BP values). A lowercase “c” will designate which values are set to use central BP values (e.g. HR
becomes cHR).
Additional calculations: Select which additional parameters will be
displayed when viewing a patient file. Options include:
• AASI
• Smoothness Index
• Morning Surge
• White Coat Analysis
• Coefficient of Variation
65
Selecting any of these options will make them visible on corresponding tabs
and graphs.
Figure 30: Configuration Window, Data Settings
Display Settings
This feature allows you to customize the color scheme of the graphs and charts
(Figure 31). Customizable palettes allow you to fine-tune the color scheme
for optimum reproduction by your printer. Shading on the graph indicates
the period of the study. The default colors (which can be changed using the
Configuration>Display tab) are the following:
66
• Blue shading: Indicates the asleep period of the study.
• Yellow shading: Indicates the white coat period, which is the first hour of
the study (appears only if enabled).
• Light green shading: Indicates a dose response period (appears only if
programmed).
• Light teal shading: Indicates the periods used to calculate Morning Surge
(appears only if enabled).
To customize the color palette:
1.Click on the tab for the attribute you want to change.
2.To change a color, click on it. A color palette window will appear, showing
48 basic colors. You may select one of these, or you may create your own
custom colors by clicking on the Define Custom Colors button.
3.Configure the color then click Add to Custom Colors.
4.Repeat this process for each color you want to change.
5.Click OK to save changes.
Figure 31: Configuration Window, Display Settings
Diary Comment Settings
You can use this feature to keep track of entries from patient diaries describing the
patient’s activities during BP measurements. The entries in this window (Figure 32)
are a default list which can be customized by adding, editing, or deleting entries.
The entries in this list are incorporated into a list that appears in the pull-down menu
under the Diary Comments column located on the ABP Data tab.
To add a new diary comment:
1.In the Diary Comments tab of the Configuration window, Click New.
2.Type the text for the new diary comment.
3.Click anywhere to exit the text entry window and store the diary comment.
4.Click OK to save your changes and exit the Configuration window
67
To delete a diary comment:
1.In the Diary Comments tab of the Configuration window, select the diary
comment that you want to delete.
2.Click Delete.
3.Click OK.
Figure 32: Configuration Window,
Diary Comments
To edit a diary comment:
1.In the Diary Comments tab of the Configuration window, select the diary comment that you want to edit.
2.Edit the text, as desired.
3.Click anywhere to exit the text entry window and store the diary comment.
4.Click OK to save your changes and exit the Configuration window.
Email Settings
The Email feature creates a new email message, attaches selected patient data
files or programming templates, and sends the email to a specified destination.
To set up email for AccuWin Pro™ 4 (Figure 33):
1.Choose the type of connection you are using by selecting LAN or Dial up.
2.Fill in the Email server settings. This information is available from your Internet
service provider (ISP) or office network administrator. Your ISP may require you
to check the Authorize box in order for you to send email.
3.The Email settings you fill in will appear in the header of your email: the name
of the recipient, your return email address, the subject of the email and a
message of your choosing. All bolded categories on the tab are required.
68
Encryption Options allow you to encrypt your emails with a key of your choosing.
Patient files are always encrypted. If the key is included in the file, any copy of
AccuWin Pro™ 4 can open the file. To increase security, uncheck the box for
Include key in file and type in a unique encryption key. The recipient of the emailed
file must have the key to open the attached file.
Figure 33: Configuration Window, Email Settings
Report Settings
This feature allows you to format your reports and to choose what information is included in them.
To format a report:
1.From the Configure menu, select Preferences. Select a profile and click Edit.
2.Click the Reports tab and then the Formats tab.
3.Select which items will be included in your One Page report, Full Report, and Standard Report. Select or de-select the
checkboxes on the right to make these changes (Figure 26).
4.To create a new report, click New Report, enter a name, and select the pages you want to appear in the report.
5.To delete any of these reports, select the report and click Delete Report.
6.Enter a Report Title by typing the title of your choice in the box provided. The title appears as a header on each page of
the report. Each report format allows for a different report title.
7.To change the graph type, graph scale, and horizontal sight line settings, Click Details (Figure 27).
Export Settings
This feature allows you to export reports either ASCII or GDT output (Figure 34), which is useful when the data will be
merged with a database. GDT is a format commonly used to share
computer medical records.
To change export settings, navigate to report>configure, then click on
the Export tab within the Configuration window.
69
1.To configure export to ASCII output, make selections in these areas:
• Delimiters: Choose which character will separate field items in
the database.
• Export: Choose exactly what information will be exported.
2.To configure export to GDT output, do the following:
• Select the Export GDT tab.
• Click the GDT Summary checkbox.
Figure 34: Configuration Window, Export Settings
14.
Overview of
Event Codes
Event Codes (EC) are used during the review of ABPM data. The codes are displayed in the table on the ABP Data tab and in
the Reviewed and Omitted BP data report pages under the columns labeled EC. Event Codes describe the conditions under
which the BP measurement was taken. They are also accompanied by solutions, if applicable, that can be taken to avoid
their occurrence in the future.
NOTE: Codes do not automatically indicate that a reading is invalid; they serve only as guides to help you review the data.
Event Code Definitions
70
Code
Description in AccuWin Pro™ 4
Solution or Response
1
Weak or no oscillometric signal
Check position and tightness of the cuff.
2
Artifact/erratic oscillometric signal
Remain still during the BP reading.
3
Exceeded retry count: 4 attempts
Remain still during the BP reading.
4
Exceeded measurement time limit: 140 seconds
Check the air hose connections and make certain the cuff is tight.
5
Results outside of published range: BP: 25-260 mmHg
HR: 40-200 bpm
Retry the reading by pushing the Start/Stop button. If the problem
persists, return the unit for service.
6
Release interval violation
Retry the reading by pushing the Start/Stop button. If problem persists,
return the unit for service.
85
Reading aborted – blocked valves or pneumatics
Check the air hose connections and make certain the air tubing is
not crimped.
86
Reading aborted – user abort
Restart the reading by pushing the Start/Stop button.
87
Reading aborted – inflate time-out or air leak
Check the air hose and cuff.
Code
Description in AccuWin Pro™ 4
Solution or Response
88
Reading aborted – safety time-out
Retry the reading by pushing the Start/Stop button. If the problem
persists, return the unit for service.
89
Reading aborted – cuff over- pressure
Check for blocks or kinks in the air hose.
90
Service required – power supply out of range or other
hardware problem
Replace the batteries. If the problem persists, return the unit for service.
91
Service required – safety override fitted or auto-zero
out of range
Retry the reading by pushing the Start/Stop button. If the problem
persists, return the unit for service.
94
Low battery warning
Replace the batteries. If the problem persists, return the unit for service.
97
Service required – transducer out of range
Return the unit for service.
98
Service required – A/D out of range
Return the unit for service.
99
Service required – EEPROM calibration data
CRC failure
The unit needs to be recalibrated. Return for service.
108
Dose response sequence start
Review full dose response sequence on Dose Response Statistics tab.
109
Dose response sequence end
Review full dose response sequence on Dose Response Statistics tab
110
Event marked by patient
In ABP table, select desired comment.
111
Day to night mode switch
If desired, adjust ABP Data graph to match the time marked by the
patient.
112
Night to day mode switch
If desired, adjust ABP Data graph to match the time marked by the
patient.
71
15.
Administrative
Tools
AccuWin Pro™ 4 includes administrative tools that implement additional security-related features. With AccuWin Pro™ 4
Admin Tools, you can create new user accounts, change user access levels, reset user passwords, enable the login process,
and enable automatic logoff. The available user roles are as follows:
• Administrative: Full access to entire functionality of
AccuWin Pro™ 4, including editing Admin Tool settings.
• User: Full access to entire functionality of AccuWin Pro™
4, except for editing Admin Tool settings.
72
To display the Admin Tools window:
1.From the Configure menu, select Admin Tools.
2.If the Enter Name and Password dialog window appears,
enter your administrative name and password, and click
OK. (The window appears if you have not logged in as an
administrator or if login security is not enabled.)
3.The first time you access Admin Tools, you must use the
default user name and password provided when the
AccuWin ProTM 4 was downloaded. For assistance,
please visit www.suntechmed.com or contact SunTech
Medial customer support. See section 18, Technical
Assistance, for contact information.
Figure 35: Admin Tools Window
Specifying Login Options
AccuWin Pro™ 4 includes the flexibility of enabling or disabling login security, which requires users to log in with a password.
Enabling this option supports the HIPAA access protection requirements. If your facility uses an Electronic Medical Record
(EMR) system or another system that already provides login security, you may not want to enable login security in AccuWin
Pro™ 4.
When login security is enabled, you can also set the software to automatically logoff users after a specified period of
inactivity in AccuWin Pro™ 4.
To enable login security:
1.In the Admin Tools window, click the Use Passwords checkbox. A check indicates that the option is enabled.
2.Click Done.
To enable automatic logoff:
1.In the Admin Tools window, click the Auto Logoff Enabled checkbox.
2.In the Auto Logoff Minutes box that appears, enter the number of minutes that must elapse before an inactive user is
automatically logged off. Alternatively, you can click the Up or Down arrow to select a number. You can set the number
of minutes between 1 and 240; the default is 20 minutes.
3.Click Done.
Adding User Accounts
An AccuWin Pro™ 4 administrator can create a user at either an administrative or one of two user levels. Each new user is
assigned a default password of “user”. When new users first log in, they must change the default password before they can
perform any tasks in AccuWin Pro™ 4. This applies to both administrative and user accounts.
73
To add a new user:
1.In the Admin Tools window, click New User.
2.In the User Name field that appears, enter the new user login name.
3.In the Select Role field, use the drop-down menu to select the level/role for the user.
4.Click OK to create the new user.
5.Click OK to save changes.
Changing User Level
You can change user account levels, but you cannot change user names.
To change user level:
74
1.In the Admin Tools window, click the user account you want to change.
2.Click Change Role. This option toggles the user level that appears in the Role column.
3.Click Done.
Deleting User Accounts
You can delete both administrative and user-level accounts; however, you cannot delete an administrator account if it is the
only one. You also cannot delete yourself. Deleting a user account prevents the user from logging into AccuWin Pro™ 4, if
the login security feature is enabled.
To delete a user account:
1.In the Admin Tools window, click the user account you want to delete.
2.Click Delete User.
3.A confirmation message appears. Click Yes to continue deleting the user account.
4.Click OK.
Resetting User Passwords
When a user forgets his or her password, that user must contact the AccuWin Pro™ 4 administrator, who will reset the user’s
password to the default password of “user.” When he or she first logs in again, the user must change the default password
before being able to perform any tasks in AccuWin Pro™ 4.
To reset a user password:
1.In the Admin Tools window, click the user account you want to change.
2.Click Reset Password.
3.Click Yes to confirm resetting the password.
4.In the confirmation message that appears, click OK.
5.Click OK.
75
16.
Maintaining and
Cleaning the Oscar 2
The Oscar 2 system is designed to perform in conformity with the description contained in this user manual and
accompanying labels and inserts, when assembled, operated, maintained, and repaired in accordance with the instructions
provided. After use, it is important to perform preventative maintenance to ensure the safe and efficient operation of the
monitor. It is your responsibility to:
• Check calibration of the device every two years.
• Never knowingly use a defective device.
• Immediately replace parts that are broken, worn, missing, incomplete, damaged or contaminated.
• Contact the nearest authorized service center should repair or replacement become necessary.
76
Further, the user of the device bears sole responsibility for any malfunction that results from improper use, faulty
maintenance, improper repair, damage or alteration by anyone other than SunTech Medical or authorized service personnel.
While usage will have an impact, it is expected the monitor will be in service for 8 years. Typically, an electromechanical
pump determines the lifetime of the monitor. Service and support, including relevant accessories, will be available up to 7
years following the last date this product is manufactured by SunTech Medical. For a list of service centers, see section 18,
Technical Assistance.
Cleaning After Use
Oscar 2
The Oscar 2 monitor cannot be sterilized. DO NOT immerse the monitor in any fluid, or attempt to clean with any liquid
detergents, cleaning agents, or solvents. You may use a soft, damp cloth to remove dirt and dust from the monitor. If the unit
does become immersed in water, do not use; contact our service department.
Orbit Cuff & Accessories
Remove the bladder for cleaning. Dampen a soft cloth with a mild medical grade disinfectant and wipe the bladder, let it air
dry. The fabric shell of the Orbit cuff may be machine-washed in cold water with a mild disinfectant. Line dry this cuff only machine drying can cause damage to the fabric shell of the Orbit cuff.
The bladder needs to be inserted back into the cuff sleeve so the pneumatic hose portion of the bladder goes through the
tube opening on the cuff. Please note that the pneumatic hose connection should face upward when using the Orbit cuff on
either the right or the left arm.
CAUTION: Do not machine wash bladder
Maintenance and Repairs After Use
Visually inspect cables, material, pneumatic hoses, and the monitor case for cracks, fraying, or kinks. DO NOT use
the monitor or cuff if there are any signs of damage. Please contact our service department if any damage or defects
are identified.
The Oscar 2 does not contain any user serviceable internal parts and should only be opened by an authorized service
representative. To return for service, please send to your nearest SunTech office, listed above, care of Support and Service.
Alternatively, please visit our website, www.SunTechMed.com, to request more information.
77
Calibration Verification Procedure
It is recommended that you check the accuracy of the Oscar 2 once every two years. If needed, an authorized service center
may recalibrate the pressure transducers in the monitor. To verify calibration, the Oscar 2 must first be placed into the proper
mode. Follow the steps below:
1.Remove and then replace one of the two “AA” batteries.
2.After the number of readings is displayed, press and hold down the Start/Stop key.
3.The unit will display the software version.
4.The unit will display the battery voltage.
5.You will then hear a click as the valves are closed.
6.You will now see “0 mmHg” displayed.
The monitor’s calibration can now be checked against a calibrated mercury column.
78
1.Place a t-tube (part #98-0030-00) between the hoses connecting the monitor and the cuff.
2.Wrap the cuff around a suitably sized can or bottle. This acts as the reservoir for the unit.
3.Attach the third end of the “T” tube into a calibrated mercury column, which gives you access to the bulb and a
reference.
4.Using the bulb of the calibrated mercury column, inflate the cuff to 250 mmHg.
5.Once the pressure has stabilized at this level, the LCD should match the mercury column by ± 2.0 mmHg.
6.Check the unit against the column every 50 mmHg from 250 to 50 mmHg. The monitor should be within ± 2.0 mmHg.
If it is not, the monitor needs to be returned to the service department for recalibration or repair.
NOTE: To return the Oscar 2 to its normal operating mode, remove and replace one of the batteries.
17.
Limited
Warranty
Oscar 2 Ambulatory Blood Pressure Monitoring System
SunTech Medical provides to the original purchaser the following limited warranty from the date of original invoice.
Serialized blood pressure monitor SunTech ABPM Cuffs
Accessories (i.e. patient hoses, interface cables, etc.)
24 months
6 months
90 days
SunTech Medical, Inc. warrants each instrument to be free from defects in material and workmanship. Liability under this
warranty covers servicing of the instruments when returned from the customer’s facility prepaid to the prospective factory
depending on location. SunTech Medical will repair any component(s) or part(s) that it finds to be defective during the period
of this limited warranty. Should a defect become apparent, the original purchaser should notify SunTech Medical of the
suspected defect. The instrument should be carefully packaged and shipped prepaid to the appropriate service center listed
in section 18, Technical Assistance.
The instrument will be repaired in the shortest possible time and returned prepaid by the same shipping method as received
by the factory.
This limited warranty is void if the instrument has been damaged by accident, misuse, negligence, or serviced by any person
not authorized by SunTech Medical.
This limited warranty contains the entire obligation of SunTech Medical and no other warranties expressed, implied, or
statutory are given. No representative or employee of SunTech Medical is authorized to assume any further liability or grant
any further warranties except as set herein.
79
18.
Technical
Assistance
For any questions, please reference the Help section within the software, this user manual, or our website. If these do not fully
address your problem, please contact our service department.
80
USA, Canada, and Latin America
SunTech Medical, Inc.
507 Airport Blvd, #117
Morrisville, NC 27560-8200
Phone: 1-919-654-2300
1-800-421-8626
Fax: 1-919-654-2301
Europe, Middle East, and Africa
SunTech Medical, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Road
Eynsham, Oxfordshire OX29 4TS
England
Phone: + 44 (0) 1865-884-234
Fax: + 44 (0) 1865-884-235
Asia-Pacific
SunTech Medical, Ltd.
2/F of Building A, Jinxiongda
Technology Park
Guanlan, Bao’an District Shenzhen,
518110, PRC
Phone: + 86-755-2958-8810
+ 86-755-2958-8986 (Sales)
+ 86-755-2958-8665 (Service)
19.
Radio Frequency
Compliance Requirements
This device contains a transmitter module identified by FCC ID: XDULE40-D2 and Industry Canada: IC 8456A-LE4D2. It has
been tested and found to comply with the limits for a Class B device. Changes or modifications not expressly approved by the
manufacturer could void the user's authority to operate the equipment. This device complies with Part 15 of the FCC Rules for
the United States. Operation is subject to the following 2 conditions:
1. This device may not cause interference.
2. This device must accept any interference received, including interference that may cause undesired operation.
81
20.
Electromagnetic Compatibility
System Requirements
The Oscar 2 needs special precautions regarding EMC and needs to be installed and put into service according to the
electromagnetic compatibility information that is listed below.
WARNING: The use of an ACCESSORY, transducer or cable with ME EQUIPMENT and ME SYSTEMS
other than those specified may result in increased EMISSIONS or decreased IMMUNITY of the ME
EQUIPMENT or ME SYSTEM.
82
Immunity
test
IEC 60601
test level
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted
RF IEC
61000-4-6
Radiated
RF
N/A
N/A
Portable and mobile RF communications equipment should be used no closer to any
part of the SunTech Oscar 2, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = [3.5/V1] √P
d = [3.5/E1] √P
IEC
61000-4-3
3V/m
80 MHz to
2.5 GHz
3 V/m
80MHz to 800MHz
d = [7/E1] √P
800MHz to 2.5GHz
where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer and d is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey a, should be less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the SunTech Oscar 2 device is used exceeds the applicable RF compliance level above, the SunTech Oscar 2 device
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SunTech Oscar 2 device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
83
Recommended separation distances between portable and mobile RF communications equipment and the SunTech Oscar 2 device
The SunTech Oscar 2 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations,
walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by
SunTech Medical from the information in the table shown below.
84
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
d = [3.5/V1] √P
80 MHz to 800 MHz
d = [3.5/E1] √P
800MHz to 2.5GHz
d = [7/E1] √P
0.01
N/A
0.12
0.23
0.10
N/A
0.38
0.73
1
N/A
1.2
2.3
10
N/A
3.8
7.3
100
N/A
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
21.
Product Disposal
Device
Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as
specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste
Electronic and Electrical Equipment (WEEE).
If this product is contaminated, this directive does not apply. Please dispose of materials according to local regulations for
medical waste.
Battery Disposal
The SunTech Oscar 2 device contains a lithium ion battery that contains materials which may be hazardous to human health.
Do NOT dispose of battery in domestic waste!
Instead, please dispose of in an environmentally responsible way, or return the battery to SunTech Medical. A prepaid return
label can be obtained. Please see our website for more information about our environmental policy at
http://www.suntechmed.com/about-suntech/environmental-policy
Cuff
Do not return used cuffs. Used blood pressure cuffs may be contaminated medical waste and should be dealt with in
accordance to your local regulations for medical waste.
85
22.
86
References
1. Pickering TG, Shimbo, D, Haas D. Ambulatory Blood-Pressure Monitoring. New England Journal of Medicine 2006;
354(22): 2368-2374.
2. Marchiando RJ, Elston MP. Automated Ambulatory Blood Pressure Monitoring: Clinical Utility in the Family Practice
Setting. American Family Physician 2003; 67(11): 2343-2350.
3. White WB. Ambulatory blood pressure as a predictor of target organ disease and outcomes in the hypertensive patient.
Blood Pressure Monitoring 1999; 4(3): 181-184.
4. M. Shimizu and K. Kario, Review: Role of the augmentation index in hypertension, Therapeutic Advances in
Cardiovascular Disease, vol. 2, Feb. 2008, pp. 25-35.
5. T. Morgan, et al., Effect of different hypertensive drug classes on central aortic pressure, American Journal of
Hypertension, vol. 17, 2004, pp. 118-123.
6. Association for the Advancement of Medical Instrumentation. The National Standard of Electronic or Automated
Sphygmomanometer. Arlington, VA: AAMI; 1996.
7. Jones SC, Bilous M, Winship S, Finn P, Goodwin J. Validation of the Oscar 2 oscillometric 24-hour ambulatory blood
pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood
Pressure Monitoring 2004; 9(4): 219-223.
8. Goodwin J, Bilous M, Winship S, Finn P, Jones S. Validation of the Oscar 2 oscillometric 24-h ambulatory blood
pressure monitor according to the British Hypertension Society protocol. Blood Pressure Monitoring 2004; 12(2):
113-117.
9. Chobanian A, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, et al. The seventh report of the Joint National
Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No. 03-5233
May 2003.
10. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, et al. Recommendations for blood pressure
measurement in humans and experimental animals: Part 1: Blood pressure measurement in humans: A statement for
profressionals from the subcommittee of professional and public education of the American Heart Association Council
on High Blood Pressure Research. Hypertension 2005; 45: 142–161.
11. O’Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia G, et al. European Society of Hypertension recommendations
for conventional, ambulatory, and home blood pressure measurement. Journal of Hypertension 2003; 21: 821-848.
12. Urbina E, Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, et al. Ambulatory blood pressure monitoring in
children and adolescents: Recommendations for standard assessment, a scientific statement from the American Heart
Association, Atherosclerosis, Hypertension, and Obesity in Youth Committee of the Council on Cardiovascular Disease
in the Young and the Council for High Blood Pressure Research. Hypertension 2008; 52: 433-451.
13. Soergel M, Kirschstein M, Busch C, Danne T, Gellerman J, Holl R, et al. Oscillometric twenty-four-hour ambulatory
blood pressure values in health children and adolescents: A multicenter trial including 1141 subjects. Journal of
Pediatrics 1997; 130(2): 178-184.
14. Wühl E, Witte K, Soergel M, Mehls O, Schaefer F. Distribution of 24-h ambulatory blood pressure in children:
normalized reference values and role of body dimensions. Journal of Hypertension 2002; 20(10): 1995-2007.
15. Owens P, tkins N, O’Brien E. Diagnosis of white coat hypertension by ambulatory blood pressure monitoring.
Hypertension 1999; 34: 267-272.
16. Head G, McGrath BP, Mihailidou AS, Nelson MR, Schlaich MP, Stowasser M, et al. Ambulatory blood pressure
monitoring in Australia: 2011 consensus position statement. Journal of Hypertension 2011; 30 (1): 1-14.
17. Schillaci G, Parati G. Ambulatory arterial stiffness index: merits and limitations of a simple surrogate measure of arterial
compliance. Journal of Hypertension 2008; 26(2): 182-185.
18. Mancia G, Grassi G. Mechanisms and clinical implications of blood pressure variability. Journal of Cardiovascular
Pharmacology 2000; 35(7 Suppl 4): S15-9.
19. Parati G, Schumacher H, Bilo G, Mancia G. Evaluating 24-h antihypertensive efficacy by the smoothness index: a metaanalysis of an ambulatory blood pressure monitoring database. Journal of Hypertension 2009; 28 (11):2177-2183
87
SunTech Medical, Inc.
507 Airport Boulevard, Suite 117
Morrisville, NC 27560-8200 USA
Tel: + 1.919.654.2300
1.800.421.8626
Fax:+ 1.919.654.2301
www.SunTechMed.com
SunTech Medical, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Road
Eynsham, Oxfordshire OX29 4TS
England
Tel:+ 44 (0) 1865.884.234
Fax:+ 44 (0) 1865.884.235
www.SunTechMed.com
SunTech Medical, Ltd.
105 HuanGuan South Road, Suite 15 2~3/F
DaHe Community Guanlan,
LongHua District, Shenzhen
GuangDong PRC 518110
Tel.:
+ 86-755-2958 8810
+ 86-755-29588986 (Sales)
+ 86-755-29588665 (Service)
Fax:
+ 86-755-2958 8829
www.SunTechMed.com.CN
0413
80-0062-00-MO-RevC
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