Sun-Tech Oscar Express Remote Site User manual

Oscar Express Remote Site
User's Guide

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Table of Contents
Introduction to Ambulatory Blood Pressure Monitoring......................................... 4
Introduction to the Oscar Express ABP Telemonitoring System........................... 5
Central Terminal and AccuWin-Express .................................................... 5
Remote Sites ............................................................................................. 6
Setting up a Remote Site...................................................................................... 7
Modem connections................................................................................... 8
Voice communication options .................................................................. 10
Introduction to the Oscar Express ABP Monitor: Oscar 2................................... 13
Operation ................................................................................................. 13
Specifications........................................................................................... 14
Safety and Effectiveness ......................................................................... 15
Warnings and Contraindications .............................................................. 15
Oscar 2 at a Glance................................................................................. 17
Preparing the Patient for Oscar 2 ABP Study .......................................... 18
Oscar Express Data Transfer with Central Terminal .......................................... 21
Connecting the Oscar 2 Monitor to the Modem ....................................... 21
Overview of AccuWin-Express Report Symbols ................................................. 24
Troubleshooting.................................................................................................. 25
Oscar Express and AccuWin-Express Technical Assistance ............................. 28
Maintaining and Cleaning the Oscar 2................................................................ 29
Cleaning After Use................................................................................... 29
Maintenance After Use ............................................................................ 29
Annual Maintenance ................................................................................ 29
Products and Accessories .................................................................................. 31
Limited Warranty ................................................................................................ 32

4
Introduction to Ambulatory Blood Pressure Monitoring
The rationale for using ambulatory blood pressure monitoring (ABPM) is based upon the enormous
variability of a person’s blood pressure over time. A traditional view is that adverse effects of blood
pressure (BP) on the circulatory system depend on the average level of pressure over time.
However, scientific evidence and sound theoretical reasons support multiple measurements of BP
as better predictors of pressure-related clinical outcomes than single measurements. “In every
study in which Ambulatory Blood Pressure Monitoring has been compared with casual blood
pressure measurements, ABP has proved superior in predicting either target organ damage,
morbid events,” or cardiovascular risk.1,2,3
Casual blood pressure measurements taken in a doctor's office or clinic or by patients themselves
are not representative of blood pressure readings throughout the 24-hour day. “Several clinical
problems are better elucidated by ABPM than by casual readings. These include borderline
hypertension with target organ involvement; “resistant” hypertension; episodic hypertension;
“office” or “white coat” hypertension and evaluation of episodic hypotensive symptoms.”4
Ambulatory blood pressure monitoring provides an accepted clinical tool for collecting multiple BP
measurements to better assist clinicians with diagnosis and management of hypertension. The
data obtained from ambulatory blood pressure monitors is highly accurate and useful for managing
a wide variety of hypertensive situations including:
•Borderline hypertension
•White coat hypertension
•Resistant hypertension
•Episodic hypertension and/or anxiety disorders
•Hypertension during pregnancy
•Childhood hypertension
•Efficacy of anti-hypertensive drug therapy on a 24 hour basis
•Changes in diet and daily routine designed to reduce hypertension
•Hypotensive symptoms
•Clinical trials of pharmaceutical agents, especially anti-hypertensive agents
•Nocturnal hypertension
________________________
1. Pickering, T. G. et al. “What is the role of ambulatory blood pressure monitoring in the management of hypertensive patients?”
Hypertension 7.2 (1985): 171-77.
2. Mansoor, G. A. and B. M. Massie. “Left ventricular hypertrophy: a potent cardiovascular risk factor and its relationship to office and
ambulatory blood pressure.” Blood Press Monitor. 4 Suppl 1 (1999): S19-S22.
3. White, W. B. “Ambulatory blood pressure as a predictor of target organ disease and outcome in the hypertensive patient.” Blood
Press Monit. 4.3-4 (1999): 181-84.
4. National High Blood Pressure Education Program (NHBPEP) Working Group on Ambulatory Blood Pressure Monitoring. National
High Blood Pressure Education Program (NHBPEP) Working Group report on ambulatory blood pressure monitoring. NIH
publication; no. 90-3028, -21. 2002. Bethesda, MD., U.S. Dept. of Health and Human Services, National Institutes of Health,
National Heart, Lung, and Blood Institute. 1990.

5
Introduction to the Oscar Express ABP Telemonitoring System
The Oscar Express Ambulatory Blood Pressure Telemonitoring System is designed to provide
easy and effective ABP monitoring at remote sites managing the clinical process of data collection,
while a central terminal manages the data handling and BP report generation. The Oscar Express
system is made up of a central terminal, and multiple remote sites each operating one or more
Oscar 2 monitors.
Using the Oscar 2 monitor and its modem capability, ABP data can be collected for a patient at a
remote site and transmitted via modem over an analog phone line to the central terminal for data
review. The central terminal handles the receipt and processing of data with the PC-based
software package, AccuWin-Express. This software provides the central terminal an easy-to-use
platform for reviewing and editing the ABP data to create a report that can be printed and sent, or
faxed, to the remote site.
The modem capability of the Oscar 2 monitor also includes remote programmability by the central
terminal. This allows the download of patient data and the upload of new study parameters to
prepare the Oscar 2 for the next patient study—all in one quick transmission. This eliminates the
time and cost of mailing or transporting an ABP monitor between sites for remote data collection
and ABP report generation.
Note: Oscar Express is currently validated for use in North America and Europe. Other regional
validations are ongoing.
Central Terminal and AccuWin-Express
The central terminal serves as the base for programming the Oscar 2 monitor for an ABP study,
receiving all ABP data, storing and processing the data, and generating reports.
AccuWin-Express is the PC-based software tool provided to the central terminal for managing data
handling and report generation. Like previous AccuWin-Pro software releases, AccuWin-Express
is a powerful application that allows maximum flexibility in the configuration, analysis, and reporting
of ABP studies. It adds the ability to program Oscar 2 monitors at multiple remote sites, receive
data from multiple remote sites, as well as manage a database to easily configure remote site
information, patient information, and patient studies.
AccuWin-Express also allows you to design and print clinical reports using either default or custom
formats. When creating your own report formats, you can include any combination of the following
data:
•Patient information
•Statistics of the ABP study—BP loads as well as maximum, minimum, and average BP
values and standard deviations
•Clinical summary—includes patient history and clinical interpretation

6
Introduction to the Oscar Express ABP Telemonitoring System
•Tabulated ABP study data
•Histograms of ABP study data and calculated variables
•Ambulatory blood pressure monitor configuration
Remote Sites
A remote site receives from the central terminal a fully initialized Oscar 2 ABP system(s), a
modem, and a cable to connect the Oscar 2 monitor to the modem. All that is needed for data
transmission is an available analog phone line.
The remote site manages the clinical process of data collection—issuing the monitor to patients,
setting up the patients with the monitor, and making sure the Oscar 2 monitor is functioning
correctly.
When the patient returns with the Oscar 2 monitor, the monitor is connected to the modem for data
transfer to the central terminal. The central terminal can retrieve the data from the Oscar 2 monitor,
program the monitor for the next patient study, and format a clinical report of the collected data to
be sent back to the remote site.

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Setting up a Remote Site
Before a remote site can perform a patient ABP study, send data to a central terminal for report
generation and receive a report back, the remote site must first set-up the modem, phone, phone
line and Oscar 2 monitor.
When you receive a remote site package from your central terminal, open the contents and you
should have each the following items:
•Oscar Express monitor system. A remote site may be issued more than one Oscar Express
monitor system depending on the need and volume of each site. Each system will include an
Oscar 2 monitor, ABP blood pressure cuff(s), monitor pouch, strap and belt. See Products &
Accessories for a complete list of items.
•Oscar Express remote site system. Each remote site should receive a remote site system
from the central terminal containing a fully Express initialized modem for Express and an Oscar
2 modem communication cable. See Products & Accessories for a complete list of items.
Your central terminal should have already set up your Oscar 2 monitor and programmed it for an
ABP study, thus making it ready for an immediate patient study. To verify this, turn on the monitor
by pressing the Start/Stop button (see Oscar 2 at a Glance). The display should show an “OE” on
the left and a number on the right indicating how many currently stored BP readings are in the
monitor, most likely 0 for zero. If this is the case, the monitor is ready for a patient study and an
Oscar Express modem data transfer is not needed until the monitor has collected ABP data from a
patient.
The “OE” indicates that the Oscar 2 monitor has been enabled for Oscar Express modem
communication. If the display does not show an “OE”, you must contact your central terminal and
arrange to have the monitor Oscar Express enabled. This can only be done at the central terminal
with AccuWin-Express.
If the number of stored readings is 1 or more, it is suggested that your first modem data transfer is
to load a new ABP program onto the Oscar 2 monitor which will erase all currently stored readings
and prepare the monitor for the next patient.

8
Setting up a Remote Site
Modem connections
Whether your first Oscar Express modem data transfer with the central terminal is to program the
Oscar 2 monitor with study parameters or to send patient ABP data and re-program for the next
study, the proper connections need to be made in order to successfully perform a modem data
transfer.
1. Plug Oscar 2 to modem cable
into the 25-pin port on the
back of the modem.
2. Connect the phone cord from
the phone to the “phone” jack
on back of modem. (Optional
if using voice option 1 with a
separate dedicated phone
line. See Voice
communication options).

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Setting up a Remote Site
3. Connect phone line cord from wall jack
to “line” jack on back of modem. If you
plan on using your fax line as the
Express data line as well, a dual jack
adapter is included to convert your wall
jack into 2 jacks.
4. Connect modem power cable to the
modem and plug into to wall outlet.
The modem is now connected. The final
connection needed to perform a data
transfer is to plug the serial data cable
into the bottom of the Oscar 2 monitor.
(See Connecting the Oscar 2 monitor
to the modem.)

10
Setting up a Remote Site
Turn on the modem by depressing the On/Off button on the rear of the modem. Check that the
power light on the front of the modem illuminates to ensure a proper connection. With a phone
connected to the modem, (optional), you can pick up the phone and check that you hear a dial
tone to ensure correct connections of the phone line.
Note: the Oscar Express system is designed for analog phone lines ONLY. Data transfers through
office PBX or other digital phone systems are not expected to be compatible with the Express
modem data transfer.
Voice communication options
When preparing to do a modem data transfer with the remote site, the central terminal operator
needs to communicate with the remote site to:
•Identify which remote site is about to send data
•Identify the remote user they are speaking to
•Identify the patient for the data about to be sent
•Determine if the Oscar 2 monitor is to be programmed for a new patient study and what
parameters are needed
•Ensure that the data transfer was successful after completion
You can use one of two remote site setups illustrated on the following pages to do this. Option 1 is
highly recommended, as it minimizes the chance of ambient background noise interfering with
the modem communication. However, if the remote site only has one phone line, Option 2 will
work. Regardless of the method used, data communication begins with a person-to-person call to
the central terminal.

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Setting up a Remote Site
Set-up Option 1 (recommended)
This option requires a second phone line separate from the analog phone line being used by the
modem. This second phone line is a dedicated voice line and can be part of a PBX office or other
digital phone systems. The required analog phone line connected to the modem is for data only.
The remote site makes a person-to-person call to the central terminal operator with the voice line
and exchanges necessary information before performing a data transfer. When instructed by the
central terminal operator, the remote site starts the modem data transfer over the dedicated data
line. The remote site user does not need to pick up the data line phone connected to the modem at
any time during a data transfer.
Fig. 1. Communication Setup Option 1

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Setting up a Remote Site
Set-up Option 2
This option should be used if only one phone line is available at the remote site. In this set-up, the
same line is used for both voice and data communication.
The remote site makes a person-to-person call to the central terminal with the phone connected to
the modem and begins with voice communication. The remote site and central terminal exchange
necessary information to perform the data transfer. When instructed by the central terminal, the
remote site begins the data transfer over the same phone line. Once modem communication is
complete, the modem releases the line for voice communication again. The transfer can be
completed as a person-to-person call between the remote site and the central terminal ensuring
there were no errors.
Note: Background noise can interfere with the data communication. If the phone has a mute
button, it can be used to minimize ambient noise from interfering with the data transfer.
Fig. 2. Communication Setup Option 2

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Introduction to the Oscar Express ABP Monitor: Oscar 2
The Oscar 2 is a non-invasive oscillometric blood pressure monitor capable of measuring an adult
patient’s systolic and diastolic blood pressures. It is intended for use as an aid or adjunct to
diagnosis and treatment.
AccuWin-Express is used to enable the Oscar 2 for Oscar Express modem communication. Once
enabled, AccuWin-Express is the only software package that can communicate with the Oscar 2
monitor. This includes communication over analog telephone lines via modem and direct
communication to the PC COM port. If Oscar 2-to-PC communication with AccuWin-Pro is
required, the Oscar Express option must be disabled on the Oscar 2 monitor. The Oscar Express
option can only be disabled at the central terminal by AccuWin-Express with the monitor
connected directly to the PC.
Operation
The Oscar 2 unit is worn by the patient either in a waist belt or shoulder strap and is connected to
a cuff placed around the non-dominant upper arm. The cuff is inflated automatically at intervals
that can be programmed during setup. Blood pressure is measured by the oscillometric method
that senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of
the frequency of the pressure waves also allows heart rate to be measured. The Oscar 2 monitor
can record up to 250 measurements.
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.1The 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 is used to determine overall efficacy of the Oscar 2. To obtain results of the study,
please send a written request to:
SunTech Medical
507 Airport Boulevard, Suite 117
Morrisville, North Carolina 27560-8200
_____________________
1. Association for the Advancement of Medical Instrumentation. The National Standard of Electronic or Automated
Sphygmomanometer. Arlington, VA: AAMI; 1996.

14
Introduction to the Oscar Express ABP Monitor: Oscar 2
Specifications
Method of Measurement: Oscillometry with step deflation.
Blood Pressure Range: 25-260 mmHg (max inflate 280mmHg)
Heart Rate Range: 40-200 bpm
Accuracy: ±3 mmHg
International Standards: EN 60601-1, EN 60601-2-30,
EN 60601-1-2 (EMC),
EN 1060-1, EN 1060-3, "Non-Invasive
Sphygmomanometers - General
Requirements & Supplementary
Requirements for Electro-Mechanical BP
Measuring Systems”, AAMI SP10 ES1
category C’ (battery powered)
Operating Conditions: 10°C (50°F) to 50°C (122°F)
20-95% RH non-condensing
Power: Two “AA” alkaline batteries or high
capacity rechargeable batteries (NiMH)
Calibration: Minimally, once every year
Safety Systems: Maximum inflation pressure limited to 300
mmHg; Auto safety release valve for power
failure. Maximum BP measurement time
limited to less than 180 seconds.
Size: Approximately 120 x 80 x 32 mm
Weight: Approximately 280g (including batteries)
Storage Conditions: -20°c to 70°c, 15%-95% RH non-
condensing
Data Connector: 6 pin minidin:
1=PC-TXD (data from PC)
2= N/C
3= Ground
4= PC-RTS
5= PC-RXD (data to PC)
6= PC-DTR
Max voltage on any pin = ±15V with
respect to ground.

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Introduction to the Oscar Express ABP Monitor: Oscar 2
Safety and Effectiveness
The following safety and effectiveness issues should be considered before using the Oscar 2 unit
as part of the Oscar Express system:
•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 on pregnant women and neonates have not been established.
SunTech Medical Instruments, Inc. is responsible for the safety, reliability, and performance of its
equipment under the following conditions:
•Assembly operations, extensions, re-adjustments, modifications, and repairs are carried out by
SunTech authorized personnel.
•The electrical installation of the relevant room complies with all Local, State and Federal
building and electrical codes.
•All equipment is used in accordance with instructions for its use.
Contact SunTech Medical Instruments for information before connecting any devices not
mentioned in this Oscar Express Central Terminal User's Guide.
To ensure patient safety, use only parts and accessories manufactured or recommended by
SunTech Medical Instruments.
Warnings and Contraindications
DO NOT—use in the presence of the flammable anesthetics; this could cause an explosion.
DO NOT—immerse the monitor in any fluid, place fluids on top, or attempt to clean the unit with
any liquid detergents or cleaning agents. This may cause an electrical hazard. If accidental wetting
occurs, please return to SunTech (See Oscar Express and AccuWin Express Technical
Assistance).
DO NOT—remove unit covers. The monitor does not contain any user-serviceable components.

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Introduction to the Oscar Express ABP Monitor: Oscar 2
DO NOT—use the Oscar 2 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 unit may be inaccurate.
DO NOT—use on neonates or children, and patients known to be readily susceptible to bruising.
DO NOT—attach the cuff to a limb being used for IV infusions, as the cuff inflation can block the
infusion, causing harm to the patient.
CAUTION—Substitution of a component different from that supplied may result in measurement
error. Only personnel trained or authorized by SunTech Medical Instruments should undertake
repairs.
CAUTION—If cuff fails to deflate within 3 minutes, instruct the patient on manual removal of cuff.
CAUTION—Check that operation of the unit does not result in prolonged impairment of the
circulation of the patient.
WARNING—Ensure batteries are inserted with the correct polarity. Improper installation is a
hazard.
WARNING—Oscar Express modem capability is designed for analog phone lines ONLY. Data
transfers through office PBX or other digital phone systems are not expected to be compatible with
the Express modem data transfer.
Precautions for Use
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), it may not
meet performance specifications. If the cuff fails to deflate, the patient should be instructed on its
proper and safe removal.
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.

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Introduction to the Oscar Express ABP Monitor: Oscar 2
Oscar 2 at a Glance
Start/Stop Button •TO POWER ON: When the monitor is off, press the Start/Stop
button.
•TO POWER OFF: When the monitor is on but not taking a
reading, press and hold the Start/Stop button until you hear
five quick beeps.
•TO ABORT A MEASUREMENT: When the monitor is taking a
reading and the cuff pressure is displayed, press the
Start/Stop button.
•TO START THE PROGRAMMED ABP 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.
Express Button Starts the modem data transmission from the remote site to the
central terminal and can be programmed to automatically dial the
central terminal.
Oscar Express
enabled
An Oscar 2 monitor displays an OE upon powering on to indicate the
monitor has been enabled for Express modem data transfer. If the
monitor has not been enabled for Express modem data transfer, it
does not display the OE and will not communicate with the modem.
Also displayed upon powering the monitor on is the number of BP
readings currently stored. This number appears on the right of the
LCD regardless of whether or not the monitor has been enabled for
Oscar Express.
Time Indicates current time, when flashing, the monitor turns off in the next
20 seconds unless an ABP study is started or is in Express data
transfer mode.
Systolic/Diastolic
START/STOP
Button reserved for
future programmability
Express Button

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Introduction to the Oscar Express ABP Monitor: Oscar 2
Pressure Indicates the pressure in the cuff in mmHg during BP reading.
BP Reading Immediately after a BP reading, the display shows the results of the
reading, blood pressure in mmHg followed by heart rate in beats per
minute.
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.
Percentage Indicates what percentage of Express data transfer is complete
Preparing the Patient for Oscar 2 ABP Study
In order to accurately measure blood pressure during a 24 hour ambulatory blood pressure study,
you must carefully and correctly prepare the patient.
Fitting the Blood Pressure Cuff
For reliable data collection, it is important to select the proper size cuff for the patient’s upper arm
diameter. Without using the sleeve of the cuff, wrap the cuff around the patient’s upper arm. Use
the Range Lines on the inside of the cuff to measure the arm circumference. Ensure that this
measurement is within the range of the cuff. If it is not, use another cuff size. IMPORTANT: using
wrong cuff sizes will result in false and misleading measurements.

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Introduction to the Oscar Express ABP Monitor: Oscar 2
Patient Hook-up
1. Insert the patient’s arm through the sleeve as shown
by the hand label (Fig. 3). Palpate the brachial artery.
Slide the sleeve up the arm so the ARTERY MARKER
is over the artery. Wrap cuff snugly around the arm
(Fig. 4).
2. 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, around the
neck, across the opposite side of the body.
3. Insert the Oscar 2 into its pouch with the display
showing through the window (Fig. 5). Attach the pouch
to the patient using either the shoulder strap or belt,
depending on the patient’s preference (Fig. 6). Ensure
the air hose from the unit to the cuff is not compressed,
crimped or damaged.
Fig. 3
4. To verify proper monitor operation, ensure that the monitor is on, and start a BP reading by
pressing the Start/Stop button. The clock symbol should appear indicating the Oscar 2 is in
the study mode. If problems occur, review the setup and fitting of the system or consult the
Troubleshooting section in the remote site manual.
The patient and Oscar 2 ABP system are now ready for the ABP study.
Fig. 4 Fig. 5 Fig. 6

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Introduction to the Oscar Express ABP Monitor: Oscar 2
Preparing and Educating the Patient
Preparing your patient for the ABP study is the most important step to having 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 instrumented arm hang loosely, slightly away from the body. Avoid
flexing the muscles or moving the hand and fingers of the instrumented arm.
•The patient can stop a measurement in progress by pressing the Start/Stop button.
•If programmed appropriately, the patient can start a measurement at any time the monitor is
not taking one by pressing the Start/Stop button.
•It is important that the patient knows the proper position and fit of the cuff. The cuff should be
positioned so that the ARTERY MARKER labeled on the cuff sleeve is directly over the
brachial artery. Fit the cuff snugly around the upper arm.
•While sleeping, the patient should make sure that the hose is not crimped.
•The batteries can be replaced during a study without the data being lost or interrupting the
monitor’s program. Also, the monitor can be turned off without losing its data.
•Instruct the patient on how and when to fill out the patient diary.
•Ensure the patient knows how to care for the monitor. Keep it 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.
Starting the Study
Before the patient leaves with the monitor and cuff correctly fitted, make sure that the clock symbol
shows up on the display, indicating that the monitor is in Study mode and operating correctly.
Finishing the Study
When the patient returns, remove the cuff, monitor, and strap/belt. The BP data is stored on the
monitor and is ready to be transferred to the central terminal for report generation.