Uscom BP+ User manual

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: [phone]
F: [phone]
E: [email protected]
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
1Product 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
1.4.3Power On Self-Tests ..............................................................................11
1.5 Connecting a Cuff to BP+...........................................................................12
1.6 Saving Measurements................................................................................12
2Common 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
3Theory 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
3.5Pulse Wave Parameters Calculations ........................................................23
4Maintenance 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
5Specifications......................................................................................................29
5.1 Electromagnetic Compatibility ....................................................................30
6Accessories 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 arterio-
venous 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)