BP+ User’s Manual
Central Blood Pressure Measuring Device
© Copyright Uscom Limited 2009-2017. All rights reserved.
No part of this document may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the
prior written permission of Uscom Limited. Product specifications may change
without prior notice.
CardioScope, Pulsecor and BP+ are trademarks of Uscom Limited.
Disclaimers and Limitations of Liability
The information contained in this document, including but not limited to any product
specifications, is subject to change without notice. Uscom makes no representations
or warranties of any kind concerning the contents of this document. Under no
circumstances will Uscom be held liable for any loss or other damages pertaining to
the use of this document.
Uscom Limited
Level 8, 66 Clarence St
Sydney 2000 NSW
Australia
T: +61 2 92474144
F: +61 2 92478157
E: info@uscom.com.au
W: www.uscom.com.au
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
W: www.emergogroup.com
BP+ User Manual (R7)
Part Number: 0760024-00
Pertains To: BP+ (BPPLUS-R7)
Version: 7.0
0123
Page 2 of 31 BP+ User Manual (R7)
Table of Contents
How to Use this Manual ............................................................................................... 4
Glossary ....................................................................................................................... 5
Symbols ....................................................................................................................... 6
Safety Information ........................................................................................................ 8
1 Product Overview ................................................................................................ 10
1.1 Intended Use .............................................................................................. 10
1.2 Contraindications ........................................................................................ 10
1.3 Setting Up ................................................................................................... 10
1.4 Supplying Power ........................................................................................ 10
1.4.1 Turning Device On .................................................................................. 11
1.4.2 Turning Device Off .................................................................................. 11
1.4.3 Power On Self-Tests .............................................................................. 11
1.5 Connecting a Cuff to BP+ ........................................................................... 12
1.6 Saving Measurements ................................................................................ 12
2 Common Procedures .......................................................................................... 13
2.1 Preparing for a measurement ..................................................................... 13
2.2 Placing the cuff ........................................................................................... 13
2.3 Taking a measurement ............................................................................... 13
2.4 Displaying the Result .................................................................................. 15
2.5 Cancelling the measurement ...................................................................... 15
2.6 Interpreting Signal Quality .......................................................................... 15
2.7 Displaying Pulse Wave Analysis ................................................................ 16
2.8 Settings Menu ............................................................................................ 16
2.9 Setting Inflation Target ............................................................................... 17
2.10 Setting Date and Time ................................................................................ 18
2.11 Selecting Language .................................................................................... 18
2.12 Reviewing saved measurements................................................................ 19
3 Theory of Operation ............................................................................................ 21
3.1 Physiology of wave reflection ..................................................................... 21
3.2 Blood Pressure Measurement .................................................................... 21
3.3 Display of Pulse Waveform and Rhythm strip ............................................ 22
3.4 Central Blood Pressure .............................................................................. 22
3.5 Pulse Wave Parameters Calculations ........................................................ 23
4 Maintenance and Troubleshooting ...................................................................... 24
4.1 Servicing ..................................................................................................... 24
4.2 Routine Maintenance ................................................................................. 24
4.3 Cleaning ..................................................................................................... 24
4.4 Disposal ...................................................................................................... 24
4.5 Frequently Asked Questions ...................................................................... 24
4.6 Error Message ............................................................................................ 26
4.6.1 Main Screen Message ............................................................................ 26
4.6.2 Memory Mode Message ......................................................................... 28
4.6.3 SD Card Icon Message .......................................................................... 28
5 Specifications ...................................................................................................... 29
5.1 Electromagnetic Compatibility .................................................................... 30
6 Accessories and Spare Parts .............................................................................. 31
Page 3 of 31 BP+ User Manual (R7)
How to Use this Manual
This manual uses some conventions intended to make it easier to understand.
Warning statements convey safety information to mitigate against the potential
for death or injury and are displayed in a red box with a warning symbol to the
left.
Caution statements convey information about the potential to damage
equipment, produce inaccurate data or invalidate a procedure and are displayed
in a dashed box with a caution symbol to the left.
Statements conveying helpful hints and notes are displayed with an information
symbol to the left.
Individual instructions are displayed in blue italics with accompanying text.
Text displayed on the device screen is drawn enclosed in a box.
Page 4 of 31 BP+ User Manual (R7)
Glossary
The following terms and abbreviations are used in this manual.
Term
Description
SYS BP
Systolic Blood Pressure
DIA BP
Diastolic Blood Pressure
Central SYS BP
Central Systolic Blood Pressure
Central DIA BP
Central Diastolic Blood Pressure
AI
Augmentation Index
PR
Pulse Rate
Incident wave
A wave propagating directly from the heart
NIBP
Non-invasive blood pressure
PC
Personal computer
POST
Power On Self-Test
Reflected wave
A wave propagating from a reflection site
SD
Secure Data, type of non-volatile removable storage card
Slot
A place to store a single measurement
Pulse wave
Pertaining to something above systolic, for example a signal
recorded at a cuff pressure above systolic pressure
Page 5 of 31 BP+ User Manual (R7)
Symbols
The following symbols appear on the BP+ device and in accompanying labelling
and documentation.
Symbol
Description
Class II equipment (IEC 60601-1)
Type BF applied part (IEC 60601-1) - Blood Pressure Cuff
Direct current
Warning, consult safety information
Consult instructions for use
Information
Caution
Serial interface
USB interface
Do not dispose of the BP+ as unsorted municipal waste
Manufacturer
Date of manufacture
Device serial number
Device model number
Indicates the temperature range
Indicates the humidity range
Table 1: Symbols on BP+
Page 6 of 31 BP+ User Manual (R7)
The following symbols when used in this manual refer to hardware buttons on the
device.
Symbol Button Name Functions
Start
Start measurement
Cancel measurement in progress
Right
Move to the next item
Cancel measurement in progress
Menu / OK
Show the menu or OK
Cancel measurement in progress
Left
Move to the previous item
Cancel measurement in progress
Table 2: Buttons on BP+
The following symbols when used in this manual refer to icons that appear on the
device LCD Screen.
Symbol Description
Secure Data (SD) Card inserted and ready
Secure Data (SD) Card inserted but BP+ cannot use the card
Table 3: BP+ screen icons
START
Page 7 of 31 BP+ User Manual (R7)
Safety Information
Electric Shock Hazards:
• The BP+ may be isolated from the mains supply by disconnecting the power
supply from the mains supply outlet or by disconnecting the power supply
from the monitor.
• Do not open the enclosure of the BP+ or power supply unit, especially while
they are connected to an AC supply outlet.
• Disconnect the BP+ and power supply unit from the AC supply outlet before
cleaning. Do not use liquid or spray detergents.
• Avoid ingress of liquid into any part of the BP+ or power supply unit. Do not
submerge any component in liquid. This may cause fire or electrical shock.
Explosion Hazard: Do not use the BP+ in a flammable atmosphere or where
concentrations of flammable anaesthetics may occur.
Power Supply:
• Ensure the AC supply voltage is correct and the correct mains power adaptor
is securely fitted in place before connecting the BP+ and mains power supply
to the AC supply outlet.
• Use only the mains power adapter supplied with the BP+ or a genuine
replacement part (GlobTek Inc, model GTM41060-2512).
• This product is intended for indoor use only.
• Protect from excessive force or shock.
• Do not pull output plug with excessive force.
Accessories and Equipment: Use of accessories or equipment not approved
by Uscom, or not complying with safety standards equivalent to those met by the
BP+, may lead to a reduced level of safety of the resulting system or failure of
the BP+ to operate correctly.
Connection to Personal Computer: Equipment connected to the serial or USB
port of the BP+ must be certified to applicable IEC standards (IEC 60950 for data
processing equipment and IEC 60601-1 for medical electrical equipment). All
configurations must comply with the medical electrical equipment standard IEC
60601-1 Clause 16. Anyone who connects equipment to the BP+ configures a
medical system, and is responsible for ensuring that the system complies with
the requirements of the medical electrical equipment standard IEC 60601-1
Clause 16.
Device Modification: No modification of the BP+ is allowed.
Page 8 of 31 BP+ User Manual (R7)
Removal from Use: If any of the following situations occur, stop using the BP+:
• The AC supply cable or attachment plug is damaged.
• The device has been exposed to excessive moisture.
• The device has been dropped and damaged or shows obvious signs of
breakage.
• The device display remains blank when turned on.
Contact with Patient: Do not touch any exposed metal parts on the BP+ (in
particular interface connectors) while simultaneously touching a patient.
Too frequent measurements can cause injury to the patient due to blood flow
interference.
Measurement in an arm where intravascular access or therapy or an arteriovenous shunt is present could result in injury to the patient.
Pressure applied during measurement may cause discomfort or injury where the
patient has had a mastectomy on the side the cuff is applied.
Operator Attendance: The operator must be in continual attendance while using
the BP+.
The operator should check, by observation that operation of the BP+ does not
result in prolonged impairment of the circulation of the blood of the patient.
Other Equipment: Pressurisation of the cuff can temporarily cause loss of
function of simultaneously used monitoring equipment on the same limb.
Caution: Do not clean the BP+ with concentrated bleach, corrosive chemicals or
abrasive cleaning compounds.
Electromagnetic Compatibility: The BP+ complies with the electromagnetic
compatibility requirements of IEC 60601-1-2. Operation of the device may affect,
or be affected by, nearby equipment due to the effects of electromagnetic
interference. If this happens:
• Increase the separation between the BP+ and the other device.
• Connect the devices to AC supply outlets on separate circuit branches.
• Refer to section 5.1 for further compliance information and advice relating to
electromagnetic interference.
The use of a mains power adapter not approved by Uscom may result in
increased electromagnetic emissions or decreased electromagnetic immunity of
the BP+.
Page 9 of 31 BP+ User Manual (R7)
1 Product Overview
Congratulations on your acquisition of the Uscom BP+. Designed for ease of
use, accuracy and repeatability, the BP+ will easily integrate into many different
clinical and research environments. The BP+ measures brachial and central
blood pressure, and other cardiac and arterial parameters, using the cuff
oscillometric method.
BP+ central blood pressure measurements have been validated on patients who
are eighteen (18) and older.
1.1 Intended Use
BP+ is a non-invasive, compact standalone measurement device that
automatically measures systolic and diastolic pressure, and pulse rate in adult
and paediatric patients. BP+ also provides non-invasive central (aortic) systolic
and diastolic blood pressure, augmentation index, pulse waveform and other
parameters intended for use in adult patients.
BP+ performs measurements using a conventional oscillometric method via a
brachial cuff on the upper arm.
The device is intended to be used under supervision by qualified healthcare
personnel. The device is not intended for operating theatre, intensive care, or
continuous patient monitoring use.
1.2 Contraindications
This device is not intended for use on neonates, infants, or children under the
age of 3 years.
The device is not intended for operating theatre, intensive care, or continuous
patient monitoring use.
The device is not intended for measurement of blood pressure in subjects who
are pregnant.
Caution: BP+ should not be used on neonatal subjects. A paediatric subject
age is 3 years or greater, an infant is considered to be less than 3 years of age.
Caution: Federal (USA) law restricts this device to sale by or on order of a
physician.
1.3 Setting Up
To start using the device you will need to supply power, connect an inflatable
cuff, and insert an SD Card if you wish to save the measurement data.
1.4 Supplying Power
The BP+ requires DC power input to the device. The mains power adapter
provided with the monitor can provide the required DC power from most
international mains power outlets from 100 to 240 VAC and 50 to 60 Hz mains
input.
The mains power adapter is supplied with interchangeable blades. Attach the
blades that match your wall sockets.
Insert the plug at the end of the cable attached to the AC wall adapter into the
device in the socket indicated as the External DC input socket labelled .
Page 10 of 31 BP+ User Manual (R7)
Use only the mains power adapter supplied with the BP+ or a genuine
replacement part (GlobTek Inc, model GTM41060-2512).
1.4.1 Turning Device On
The device will turn on automatically when the AC power is attached.
1.4.2 Turning Device Off
To turn off the device, remove the AC power.
Turning the device off will release pressure in the cuff. A more effective way to
quickly release pressure from a subject’s arm is to remove the cuff from their
arm.
1.4.3 Power On Self-Tests
Once the device is turned on, the device will load the BP+ application into the
device internal memory. During this time it will display the following screen.
Figure 1: Boot up screen
BP+ will begin execution once loaded. The BP+ initial screen will start a power
on self-test (POST). An example initial screen is shown in Figure 2.
Figure 2: Start-up POST Screen
Once the POST is complete, the device will clear the display and present the
Device Ready screen as shown in Figure 3.
Page 11 of 31 BP+ User Manual (R7)
Figure 3: Ready Screen
1.5 Connecting a Cuff to BP+
In order to take a measurement, you will need to connect an inflatable blood
pressure cuff using the hose supplied with the cuff.
To connect the cuff hose push the air fittings together until you hear and feel a
positive “click”.
To disconnect the cuff hose, pull gently on the metal hose fitting to release the
internal lock, and remove hose from device.
The BP+ has been developed using specific cuff designs. Using alternate cuff
designs may significantly alter the accuracy of measurement.
Avoid compression or kinking the air hoses connecting the device to the cuff.
Such actions, particularly during a measurement, may result in prolonged
inflation of the cuff which cannot be resolved by the device’s built-in safeguards.
Prolonged over-inflation of a cuff may result in harm to the patient.
The operator should ensure that application of the cuff does not result in
prolonged impairment of the circulation of blood.
Do not connect cuffs with luer lock connectors to Intravenous System (IV).
1.6 Saving Measurements
The BP+ can store measurements if an SD Card is inserted. The BP+ supports
full size SD Cards with a storage capacity up to 32GB with FAT or FAT32 format.
Insert the SD Card with the logo facing up to the user.
Note: Measurements will not be stored if a compatible SD Card is not inserted
into the BP+. Look for the SD Card icon on the top left of the screen. If the icon
is not present, then no SD Card is inserted. If the icon has a red cross through it,
then the BP+ does not recognise the SD Card.
or
Do not remove the SD card while a measurement is being performed or until the
measurement is finished saving. Removing the SD card whilst a measurement is
being saved can cause corruption of the SD card file system. If the SD card is
accidently removed during a save operation its integrity should be checked using
a PC.
Page 12 of 31 BP+ User Manual (R7)
2 Common Procedures
The BP+ is designed for simple operation through the four buttons on the front of
the device. These buttons are described in Table 2.
2.1 Preparing for a measurement
The entire measurement procedure usually takes less than 90 seconds.
However, it is recommended that preparations for taking a measurement follow
similar good practice procedures to those for taking non-invasive blood pressure.
Ensure the subject is sitting comfortably upright with adequate back support.
The subject’s legs should be uncrossed and feet should be flat on the floor.
Instruct the subject to relax, remain still, breathe normally, cease talking and
avoid any movement during measurement. It is recommended that the subject is
at rest for at least five minutes before the first measurement and to repeat the
measurement at least three times, recording the median of the measurements.
2.2 Placing the cuff
Apply the deflated cuff to the subject’s left upper arm. Choose a cuff of the
correct size, as indicated by the range markings on the cuff. The cuff should be
wrapped around the arm firmly, but not tightly. The artery marker on the cuff
where the hose enters the cuff should be placed over the brachial artery. Avoid
placing the cuff over thick clothing. Avoid bunching up clothing above the cuff,
which may partially occlude the artery.
To reduce the risk of cross-infection and further abrasion, do not apply the cuff to
broken skin.
Support the subject’s forearm on a stable, horizontal surface such as a table top,
at a height such that the cuff is at the approximate level of the subject’s heart and
held away from the subject’s torso. Generally, a palm-down position is found to
be more comfortable. If the recommend instructions are not followed, any
reading can be affected by the measurement site, the position of the patient,
exercise, or the patient’s physiologic condition.
2.3 Taking a measurement
When performing a measurement, the operator should be in a position to
observe the patients’ arm/cuff and the BP+ display.
Press Start button while the main screen is displayed as in Figure 4:
Figure 4: Main measurement screen
Page 13 of 31 BP+ User Manual (R7)
There may be a short pause while the device performs a pre-measurement
check. The device will then begin inflating the cuff. During this time the status
area will display Measuring Blood Pressure and the current cuff pressure will be
displayed.
Figure 5: Measuring screen
If your model of BP+ supports “Measurement on Inflation”, the device will attempt
to determine the systolic, mean and diastolic pressures and pulse rate as the cuff
is inflated. If the model does not support measurement on inflation, or the device
is unable to determine the blood pressure during inflation, once the pre-set target
pressure is reached, the device will gradually deflate the cuff at a controlled rate
of approximately 3 mmHg/s. During this time, the device will attempt to
determine the systolic, mean and diastolic pressures, as well as pulse rate as the
cuff is deflated. If the initial inflation pressure is less than the systolic pressure,
the device will re-inflate the cuff to a higher pressure before the controlled
deflation. If the BP+ does not successfully measure the subject’s blood pressure,
selecting a higher or lower inflation target may help.
If your model of BP+ supports “Measurement on Inflation”, and it successfully
determines the blood pressure during inflation, the device will directly inflate the
cuff to the suprasystolic pulse wave pressure. Otherwise, once the blood
pressure and pulse rate has been determined by deflating the cuff, the device will
re-inflate the cuff to the suprasystolic pressure (approximately 30 mmHg above
the measured systolic pressure). This suprasystolic pulse wave pressure will be
maintained for around 12 seconds. During this time, the status area will display
Measuring Pulse Wave. After the pulse wave measurement is finished, the cuff
pressure will be completely released. This marks the completion of the entire
measurement cycle. The BP+ will then process the acquired data and display
the result on the screen.
Page 14 of 31 BP+ User Manual (R7)
2.4 Displaying the Result
Once the measurement is completed, the monitor will display all results under
the respective labels as follows:
Figure 6: BP Result Screen
10 seconds of the pulse wave signal are displayed along the bottom of the
display. Vertical red lines indicate the start of each pulse. This display can
provide a visual indication of any arrhythmias and inter-beat variability (such as
that caused by respiratory load).
Measurement results may not be accurate in the presence of arrhythmias.
Arrhythmias may be apparent on the rhythm strip.
The main screen will also display the average pulse wave pulse.
2.5 Cancelling the measurement
Press any button during a measurement to cancel the measurement and deflate
the cuff.
Note: While the device is calculating results it will not respond to button presses.
2.6 Interpreting Signal Quality
The signal quality of the pulse wave measurements will be measured by the
device and expressed as a Signal-to-Noise Ratio (SNR) on a logarithmic scale
(dB). An increase in the SNR by 3 indicates a tenfold increase in the signal
quality. The SNR acceptability is indicated on the results screen as a text status
message and can vary from Invalid, Poor, Acceptable, Good, through to
Excellent as shown in Table 4: Signal quality classification. The numeric value of
SNR is displayed on the Pulse Wave Analysis screen as shown in Figure 7.
Measurements with a SNR below 6 (Poor or Invalid) should be discarded. The
device will not display the augmentation index and central pressures in these
circumstances. It is recommended to repeat the measurement and to confirm
the patient is remaining still and not talking during the measurement. (Patients
often move when talking.)
Signal-to-Noise Ratio (dB)
Signal Quality
Classification
Colour on
Results screen
SNR < 0 Invalid Red
0 ≤ SNR < 6
Poor Red
Page 15 of 31 BP+ User Manual (R7)
Signal-to-Noise Ratio (dB)
Signal Quality
Classification
Colour on
Results screen
6 ≤ SNR < 9
Acceptable Yellow
9 ≤ SNR < 12
Good Green
12 ≤ SNR
Excellent Green
Table 4: Signal quality classification
2.7 Displaying Pulse Wave Analysis
Press button from the main screen. The monitor will display the Pulse
Wave Analysis screen as follows:
Figure 7: Pulse Wave Analysis Screen
2.8 Settings Menu
The BP+ provides a Settings menu for configuring different functions of the
monitor. The setting options include: Inflation Target, Select Language* and Set
Date and Time.
Figure 8: Settings Menu Screen
Changing some setting options require a device reset as indicated by an asterisk
(*). Whenever a change is made to an asterisk (*) setting option, the first option
Page 16 of 31 BP+ User Manual (R7)
– Exit on the Settings menu will be changed to Restart. To exit and reset select
Restart and then press to reset the monitor.
Figure 9: Settings Menu Screen – Restart
2.9 Setting Inflation Target
By default, the BP+ will initially inflate the cuff to 180 mmHg. If the actual systolic
pressure is higher than this, then the device may automatically re-inflate
additional times to measure the systolic pressure. If you have an estimate of the
systolic pressure then you may wish to set the initial inflation target to avoid
these additional inflation cycles.
Press the Settings menu will be displayed. Select the Inflation Target option
and press . The Inflation Target menu will be displayed with the current
inflation target highlighted. Press to confirm your selection or use the arrow
keys to select another value. You will be returned to the Settings screen. Note
that the Inflation Target will default to 180 mmHg if the BP+ is restarted.
Figure 10: Inflation Target Setup Screen
Note - If the subject’s actual systolic pressure is significantly lower than 180
mmHg you may reduce measurement time and discomfort by reducing the initial
inflation target.
Page 17 of 31 BP+ User Manual (R7)
2.10 Setting Date and Time
The BP+ provides a Set Date and Time menu for setting the date and time
values on the monitor.
Press The Settings menu will be displayed. Select the Set Date and Time
option and press . The date time setting menu will be displayed.
Figure 11: Date Time Setting Screen
Press to highlight a different date time element and use to select it. Then
use and to change the value of the highlighted date time element.
When finished press . The monitor will automatically store the changed value
and does not require any reset of the monitor. To return to the main screen,
select Save and Exit and press .
2.11 Selecting Language
By default, the language displayed on the monitor is English. The BP+ monitor
may support different language displays for some countries.
Press The Settings menu will be displayed. Then go to select the Select
Language option and press . The Select Language menu will be displayed
with the current language highlighted.
Figure 12: Select Language Screen
Page 18 of 31 BP+ User Manual (R7)
Use the arrow keys to select the desired language. Press to return to the
Settings menu screen. You will be returned to the Settings menu screen and a
reset is required - refer to 2.8 Settings Menu for device reset.
Some versions of monitor might only provide one language option for some
countries. Please contact Uscom for more information using the contact
information at the front of this manual.
2.12 Reviewing saved measurements
Measurements saved to the SD Card (if used) can be accessed through the
menu for review.
Press the Settings menu will be displayed. Select the Select Measurement
option and the Select Measurement menu will be displayed. If no SD Card is
inserted, then the device will prompt you to insert one.
The Select Measurement screen will display a list of measures. The most recent
measurement is at the top of the list, indicated by the Start of List entry. Use
and to highlight the measurement to review.
The screen can display up to 7 measurements. The current selection is
displayed in a different colour.
Figure 13: Selecting Saved Measurement
When more than 7 measurements are present on the SD Card, moving past the
last displayed measurement will scroll to the next page of measures. When the
end of the list is reached End of List will be displayed as the last entry.
Page 19 of 31 BP+ User Manual (R7)
Figure 14: Saved Measurement Navigation
Press to confirm your selection. The BP+ will begin to reprocess the
measurement after which it will be displayed on the main screen. If you do not
wish to open a measurement for review select Start of List or End of List and
Press .
Figure 15: Calculating Measurement
Figure 16: BP Result Screen
Page 20 of 31 BP+ User Manual (R7)
3 Theory of Operation
3.1 Physiology of wave reflection
Figure 17: Arteries of the upper body
The Uscom BP+ monitor has been developed using Pulse Wave Oscillometric
technology (referred to as BP+) and a scientific understanding of pressure wave
propagation in the arterial system. The arteries most relevant to BP+
measurement technique are shown in Figure 17.
The theory of wave reflections implies that the pressure at any location in the
arterial tree can be considered to be the sum of forward- and backward-going
pressure waves.
The initial forward-going pressure wave is generated by the contraction of the
heart’s left ventricle. Backward-going pressure waves are created when the
forward-going pressure wave encounters a change in the properties and
geometry within the arterial system. At such a point, the forward-going wave is
partly reflected, creating the backward-going pressure wave. There are multiple
reflection sites within the human arterial system.
3.2 Blood Pressure Measurement
The Cardiovascular monitor is designed to measure pressure-related information
from the upper arm using an inflatable cuff. As shown in Figure 18, the pressure
wave generated by the heart can be considered to take two paths to the upper
arm cuff, generating what are known as the incident wave and reflected wave.
• The incident wave travels from the heart, through the ascending aorta,
subclavian artery and brachial artery to reach the cuff.
• The reflected wave travels from the heart, through the ascending aorta,
aortic arch and down the descending aorta to the effective reflection site
in the abdominal aorta. At this location, some of the forward-going wave
is reflected and travels back up the descending aorta, through the
subclavian and brachial arteries before arriving at the cuff.
Measurement should be performed on the left arm. In cases where left-arm
measurement is contraindicated, measurement from the right arm can be
performed. Validation has only been performed on the left arm. As with all
oscillometric blood pressure measurements due to the additional complexity of
the wave path to the right brachial artery, results from the right arm will differ and
are not directly comparable with left-arm results.
Heart
Left brachial artery
Left
subclavian
artery
Brachiocephalic
trunk
Left common carotid artery
Right common carotid artery
Right
subclavian artery
Right brachial artery
Abdominal descending aorta
Common iliac arteries
Thoracic descending aorta
Ascending aorta
Aortic arch
Page 21 of 31 BP+ User Manual (R7)
Figure 18: Pressure wave reflection in the arterial system
3.3 Display of Pulse Waveform and Rhythm strip
Figure 19: BP Result Screen, mean beat feature points
The following are the points of interest on the pulse waveform, as indicated in
Figure 19.
• Start of the pulse, t
0
, p0
• Peak of the incident wave, t
1
, p1
• Trough between incident and reflected wave, t
2
, p2
• Peak of the reflected wave, t
3
, p3
• Trough of the dicrotic notch, t
4
, p4
• Peak following the dicrotic notch, t
5
, p5
3.4 Central Blood Pressure
The BP+ uses a physics-based model of the subclavian to brachial artery branch
to calculate central blood pressure. This model has been validated against
Incident wave path
Reflected wave path
Effective reflection site
Forward-going waves
Backward
-going wave
Upper
-
arm cuff
Page 22 of 31 BP+ User Manual (R7)
invasive pressure data obtained from the aortic arch, with measurements taken
on the left arm. Validation was performed in subjects aged between 30 and 80
years.
Central blood pressure measurement results may not be accurate in subjects
who are not similar to those used in validation.
3.5 Pulse Wave Parameters Calculations
Referring to Figure 19, the equations for calculating pulse wave parameters
displayed on the main screen and Pulse Wave Analysis screen are:
Suprasystolic Augmentation index (%):
01
03
sAI
pppp−
−
=
Suprasystolic Pulse rate variability (milliseconds):
( )
∑
−
=
−+
−
−
=
1
2
2
1,01,0
2
1
sPRV
N
n
nn
tt
N
Suprasystolic Pulse Rate (beats per minute):
( )
∑
=
−
−
−
=
N
n
nn
tt
N
2
1,0,0
1
1
sPR
Signal to Noise Ratio (decibels):
( )
( )
−
−
=
∑
=Nn
n
tptp
N
tptp
1
2
2
10
)()(
1
)()(
log10SNR
where
∫
=
=
T
t
dttf
T
tf
0
)(
1
)(
Systolic ejection period (milliseconds):
04
sSEP tt −
=
Reflected wave transit time (peak-to-peak, milliseconds):
13p
sRWTT tt −=
Reflected wave transit time (foot-to-foot, milliseconds):
02f
sRWTT tt −=
Suprasystolic Pulse Pressure (mmHg):
),max(sPP
0301
pppp −−=
Suprasystolic Pulse Pressure Variation (%) of the rhythm strip with n pulses:
(
) ( )
nn
pp min
maxsPP
n
−=
and then
( ) (
)
(
) ( )
)minmax(
2
1
minmax
sPPV
nn
nn
sPPsPP
sPPsPP+−
=
Maximum Suprasystolic pressure gradient (mmHg/s):
=
dt
tdP
t
)(
maxsdP/dt
Page 23 of 31 BP+ User Manual (R7)
4 Maintenance and Troubleshooting
4.1 Servicing
The Uscom BP+ contains no user-serviceable parts. Opening the BP+ enclosure
voids any applicable warranty.
Some frequently asked questions are answered below. If your question is not
answered, or for additional service information, please contact Uscom using the
contact information at the front of this manual.
When contacting Uscom with service related enquiries, please provide the
following information:
• Device Part Number
• Serial Number
• Description of any fault, including:
o Circumstances and operation preceding the fault
o Environment in which the device was being used at the time of the
fault
4.2 Routine Maintenance
The BP+ is designed so that no periodic adjustment or calibration is required, if it
is stored and used within the temperature and humidity ranges given in section 5
Specifications. The BP+ might not meet its performance specifications if stored
or used outside of these ranges.
The accuracy of the cuff pressure measurement should be checked annually by
a trained service technician.
The cuffs provided with the BP+ may become worn with routine use and require
replacing.
4.3 Cleaning
The device may be cleaned using lint-free cloth dampened with a mild solution of
detergent and water, 10% bleach solution, or a commercial disinfectant.
After cleaning, dry all areas with a lint-free cloth.
Avoid ingress of liquid into any part of the BP+ or power supply unit. Do not
submerge any component in liquid. This may cause fire or electrical shock.
To clean the cuff and tubing, apply a mild detergent to a slightly damp cloth and
wipe clean. Allow to dry thoroughly.
4.4 Disposal
Dispose or recycle the BP+ in accordance with regulations of your country.
Do not dispose of the BP+ as unsorted municipal waste at the end of the
product’s lifetime. The BP+ must be recycled in accordance with the WEEE
Directive 2002/96/EC (for EU) or according to the regulations of your country. To
arrange for return or disposal of the BP+ please contact your local supplier.
4.5 Frequently Asked Questions
I cannot connect the air hose to the device.
Ensure that you have the Uscom provided cuffs. When the hose connector is
fitted you will hear a click.
Page 24 of 31 BP+ User Manual (R7)
The cuff deflates during a measurement and “Safety Rule Violated” is
displayed.
There may have been an overpressure condition. For safety reasons, the cuff
will deflate if the device detects a very high pressure in the cuff, or if a significant
pressure is held for a long period of time.
The screen is completely white when I turn the device on.
The screen flickers when I turn the device on.
The device resets by itself.
Check that an appropriate AC adapter is being used.
I get the message “Cuff Too Tight or Kinked Hose” when trying to take a
measurement.
The device is having trouble inflating the cuff. Ensure that the cuff is on firmly
but not tightly, and that the hose to the cuff is not kinked, compressed or blocked.
I get the message “Invalid Signal” after taking a measurement.
This can occur when the signal is too noisy to process. Ensure the cuff is
applied firmly and the subject remains still during the measurement.
The signal is consistently very noisy (SNR < 6) even under ideal
measurement conditions.
There may be a slow leak in the pneumatic circuit. Check for damaged air
connectors, split hoses or punctured cuffs. You may wish to use a different hose
and cuff set to verify the problem.
If the problem persists, contact Uscom.
The measured blood pressure is unexpected.
The measurements change a lot each time they are measured.
Ensure that good blood pressure measurement practice is being followed as
described in Section 2.1 Preparing for a measurement. Multiple successive
measurements may be used to calculate an average value for all parameters.
Page 25 of 31 BP+ User Manual (R7)
4.6 Error Message
4.6.1 Main Screen Message
Message
Reason
User Action
Connection Failed
or
No Connection
Internal fault condition.
Consult Uscom / Uscom
certified servicing technician
Wrong power adapter used.
Check the power adapter
being used is the one
provided with the device, as
specified in Section 5
Specification
Measurement Timeout
Measurement could not be
completed within the maximum
permitted time. Safety system has
cancelled the measurement.
Redo another measurement.
Ask the patient to relax, sit
still, not to talk, no arm or
finger movement on the arm
being measured (left), etc.
Refer to section 2.1 & 2.2.
If error persists, consult
Uscom / certified servicing
technician (Please make a
note of any error number
displayed along with the error
message.)
Systolic BP too High
or
Unable to measure BP:
Range Exceeded (####)
(Where #### is the error
number)
The upper arm systolic pressure
measured is too high. The device
cannot proceed to do the Pulse
Wave measurement
Unable to Calculate
Results
Unable to Find Features
Unable to Find Pulse
Wave
Calculation error
Unable to Reinflate
The inflation target for doing the
Pulse Wave measurement is too
high
Unable to Start
Device detects an internal error
when it starts the blood pressure
measurement
Invalid Signal
The signal noise ratio is too low and
out of the valid range.
Poor Signal
The signal quality is poor
Unable to measure BP:
Please Repeat (####)
(Where #### is the error
number)
Device detects a blood pressure
measurement related error when it
is doing the blood pressure
measurement
Unable to measure BP:
Timeout (####)
(Where #### is the error
number)
Blood pressure measurement
Timeout
Unable to measure BP:
(####)
(Where #### is the error
number)
Blood pressure measurement failed
Consult Uscom/Uscom
certified servicing technician
with the BP error number
Page 26 of 31 BP+ User Manual (R7)
Message
Reason
User Action
Unable to measure BP:
Check Pneumatics (####)
(Where #### is the error
number)
Device detects pneumatics error
when it is doing the blood pressure
measurement
Check the cuff and hose is
attached correctly. If the
problem persist, consult
Uscom or Uscom certified
servicing technician. Please
make a note of the error
number.
Invalid Measurement
Data
The target measurement record
being retrieved from the SD card is
corrupted or is from an older BP+.
Delete the corrupted/invalid
record from the SD card. This
can be done by inserting the
SD card into a computer and
deleting the appropriate file.
Optionally retain a copy of the
file on the PC before deletion.
Measurement not saved
No SD inserted when the device is
trying to save the measurement
data.
Insert a compatible SD card
When the device is trying to save
the measurement data and an
invalid SD card is detected or the
saving process fails.
Check the capacity of the SD
card and make sure it is not
larger than 32GB, is SD or
SDHC compatible, and
formatted as FAT or FAT32.
Use a different SD Card if
available
When device is trying to save the
measurement data and the SD card
is full
Delete older record(s) or
replace with an empty SD
card.
When device is trying to save the
measurement data and the SD card
is not formatted correctly.
Format the SD card to FAT16
or FAT32 on a PC.
Overpressure
or
Unable to Measure BP:
Over Pressure (####)
(Where #### is the error
number)
Pressure is over the limit
Remove the cuff from the arm
and device.
Note: Device will
automatically deflate the cuff
pressure immediately.
Safety Rule Violated
Page 27 of 31 BP+ User Manual (R7)
4.6.2 Memory Mode Message
Message
Reason
User Action
Please replace SD Card.
Full or Invalid
SD card is full
Delete the old record(s) or
replace with an empty SD card
Unsupported SD Card
Invalid SD card format
Format the SD card to FAT16
or FAT32 on computer
Large capacity of SD card is inserted,
device does not support capacity
larger than 2GB
Check the capacity of the SD
card and make sure it is not
larger than 2GB
Slot is Empty
No SD card is inserted
Insert the compatible SD card
4.6.3 SD Card Icon Message
Message
Reason
User Action
Not Saved
No SD inserted when device is trying
to save the measurement data.
Insert a compatible SD card.
Repeat the measurement
When device is trying to save the
measurement data:
- Oversize SD card is detected,
device does not support capacity
larger than 32GB
Check the capacity of the SD
card and make sure it is not
larger than 32GB
When device is trying to save the
measurement data.
- SD card is full
Delete the old record(s) or
replace with an empty SD card
When device is trying to save the
measurement data.
- The format of SD card is detected
to be invalid
Format the SD card to FAT16
or FAT32
Save Failed
The measurement will not be saved
due to a calculation error
Redo another measurement
and make sure subject sits still
and no arm movement, refer
to section 2.1 and 2.2. If error
persists, consult Uscom /
certified servicing technician.
Page 28 of 31 BP+ User Manual (R7)
5 Specifications
Non-invasive upper-arm blood pressure
• Oscillometric method using step controlled
deflation
• Adult and pediatric patients
• BP Measurement range:
• Systolic: 40 to 250 mmHg
• Diastolic: 20 to 190 mmHg
• Mean: 25 to 245 mmHg
• Cuff Pressure: 0 to 300 mmHg
•
BP Measurement accuracy: Static
Accuracy: ± 3 mmHg
• Clinical Accuracy: Mean error is less
than ± 5 mmHg Standard Deviation is
less than 8 mmHg
• Pulse Rate range: 40 to 200 bpm
• Pulse Rate accuracy: greater of ±3% or
±3bpm
• Power-on self-test
• Typical measurement time within 45
seconds
Non-invasive central blood pressure
• Model-based transform of peripheral
waveform reports Systolic and Diastolic
central pressure
Pulse wave measurement
• Arterial measures:
• Peripheral Augmentation Index (sAI)
• Suprasystolic Reflected Wave Transit
Times, peak and foot (sRWTT
p,
and
sRWTT
f
)
• Cardiac function measures:
• Maximum Suprasystolic pressure
gradient (sdP/dt)
• Suprasystolic Pulse Pressure Variation
(sPPV)
• Systolic Ejection Period (sSEP)
• Suprasystolic Pulse Rate Variability
(sPRV)
• Signal to Noise ratio (SNR)
• Data Sampling Rate: 200Hz
Physical dimensions
• Size: 156 mm × 157 mm × 119 mm
• Weight: 500 g
Display and memory
• 320×240 pixel matrix 3.5” TFT colour
display
• Pulse wave waveform display
• Graphical rhythm strip display
• Status and error display
• SD Card slot, hot swappable with cards up
to 32 GB
Blood pressure cuff and hose
• Lifetime antimicrobial treatment
• Small Adult, Adult and Large Adult cuffs
available
• 1.3 m hose
Computer interface
• Computer interface specification (serial
port) available for customer configuration
Power supply
• Power Supply Unit: GlobTek Inc model
GTM41060-2512 medical grade, AC/DC
wall adapter
• AC Input: 100–240 V
AC
, 50–60 Hz, 0.6 A
• DC Output: 12 V
DC
, 2.08 A
• Use of the BP+ with the Power Supply
Unit is considered an ME system
Environmental specifications
• Operating Temperature: 10 to 40 °C (50
to 104 °F)
• Operating Relative Humidity: 15 to 80%
(non-condensing)
• Operating Atmospheric Pressure: 80 to
103 kPa
• Transport and Storage Temperature: -20
to 50 °C (-4 to 122 °F)
• Transport and Storage Relative Humidity:
15 to 80% (non-condensing)
IEC 60601-1 standard classification
• Class II Equipment
• Type BF Applied Part (the blood pressure
cuff is considered the applied part)
• Continuously powered with
measurements being taken upon demand
• Equipment not suitable for use in the
presence of a flammable anesthetic
mixture, with air or oxygen or nitrous
oxide
Warranty
• 12 month warranty on the device
• 6 month warranty on cuffs and extension
hose
Reference to standards
• EN 1060-1 /-3 /-4; IEC 60601-1;
IEC 60601-1-2 (EMC); IEC 60601-1-11
Page 29 of 31 BP+ User Manual (R7)
5.1 Electromagnetic Compatibility
Guidance and manufacturer’s declaration - electromagnetic emissions
The BP+ is intended for use in the electromagnetic environment specified below. The customer or the user of the BP+ should assure that it is used
in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The BP+ uses RF energy only for its internal function. Therefore, its RF emissions are very low
and not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The BP+ is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
The BP+ should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BP+ should be observed to
verify normal operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration - electromagnetic immunity
The BP+ is intended for use in the electromagnetic environment specified below. The customer or the user of the BP+ should assure that it is used
in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge, ESD
(IEC 61000-4-2)
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient / burst
(IEC 61000-4-4)
±2 kV for power supply lines
±1 kV for input / output lines
±2 kV for power supply lines
±1 kV for input / output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
(IEC 61000-4-5)
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
(IEC 61000-4-11)
<5 % UT (>95 % dip in UT) for 0.5
cycle
40 % UT (60% dip in UT) for 5 cycles
70 % U
T
(30 % dip in UT) for 25
cycles
<5 % UT (>95 % dip in UT) for 5 sec
<5 % UT (>95 % dip in UT) for 0.5
cycle
40 % UT (60% dip in UT) for 5 cycles
70 % U
T
(30 % dip in UT) for 25
cycles
<5 % UT (>95 % dip in UT) for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the BP+ requires continued operation during
power mains interruptions, it is recommended
that the BP+ be powered from an uninterruptible
power supply.
Power frequency
(50/60 Hz)
magnetic field
(IEC 61000-4-8)
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
(IEC 61000-4-6)
Radiated RF
(IEC 61000-4-3)
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the
BP+, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
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 metres (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 BP+ is used
exceeds the applicable RF compliance level above, the BP+ should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the BP+.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the BP+
The BP+ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the BP+
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the BP+ as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73 1 1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.
Essential Performance of the BP+ as required by IEC 60601-1-2 § 3.201.2 is defined as 1) opening of cuff pressure valves if detected cuff
pressure exceeds 300 mmHg or 15 mmHg for more than 3 minutes; 2) no degradation of blood pressure measurement accuracy beyond
that given in the specification.
Page 30 of 31 BP+ User Manual (R7)
6 Accessories and Spare Parts
Small Adult Cuff, 17-26cm
Part: U50314
This is a re-useable, latex free cuff suitable for arm circumference 17 cm to 26
cm.
Medium Adult Cuff, 24-32cm
Part: U50315
This is a re-useable, latex free cuff suitable for arm circumference 24 to 32 cm.
Large Adult Cuff, 32-42cm
Part: U50316
This is a re-useable, latex free cuff suitable for arm circumference 32 cm to
42cm.
Medical grade mains power adapter with international blade set
Model Number: GlobTek Inc GTM41060-2512
Part: U50312
Suitable for use as supply of external DC power to the BP+. Comes with US,
Europe, United Kingdom, and Australia/New Zealand blade set. Has medical
grade certification for use in hospital environments.
Page 31 of 31 BP+ User Manual (R7)
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