Welch Allyn ProBP-3400 User Manual
Welch Allyn Connex® ProBP™ 3400
digital blood pressure device
Directions for use
© 2011 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication,
the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media
provided byWelch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted
without written permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that
may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of
intended use published in this manual.
Welch Allyn, SureBP Technology, and Welch Allyn FlexiPort are registered trademarks of Welch Allyn. The
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by Welch Allyn is under license.
Software in this product is Copyright 2011 Welch Allyn or its vendors. All rights are reserved. The software is
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intended in the operation of the product in which it is embedded. The software may not be copied, decompiled,
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103701 (CD)
DIR 80016085 Ver. B
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn, Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland
Contents
Initial device setup ................................................................................. 1
Introduction ............................................................................................. 3
Symbols ................................................................................................... 5
General warnings and cautions ............................................................. 9
iii
Intended use ...................................................................................................................................... 3
NIBP warnings and cautions ................................................................ 13
Contents checklist ................................................................................. 15
Controls and indicators ......................................................................... 17
Screen elements .................................................................................... 19
Connections ........................................................................................... 21
Blood pressure hose and cuff .............................................................. 23
Blood pressure cuff selection ....................................................................................................... 23
Power transformer ................................................................................ 25
Power transformer and wall plug/line cord assembly .............................................................. 25
Charge the device ........................................................................................................................... 26
Setup ...................................................................................................... 27
Insert the battery ............................................................................................................................. 27
Mount the device ............................................................................................................................ 28
Assemble power cord and wall plug/line cord .......................................................................... 28
Charge the ProBP 3400 .................................................................................................................. 28
Initial startup .................................................................................................................................... 28
iv
Contents Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Battery ................................................................................................... 31
Startup .................................................................................................... 33
Standby mode ....................................................................................... 35
Blood pressure measurement .............................................................. 37
Settings .................................................................................................. 39
Settings matrix ................................................................................................................................. 39
Unit of measure ............................................................................................................................... 39
Pressure presets ............................................................................................................................. 40
Bluetooth wireless technology ..................................................................................................... 40
Advanced settings .......................................................................................................................... 41
Data review ............................................................................................ 45
Review data ..................................................................................................................................... 45
Delete data ....................................................................................................................................... 45
Maintenance and service ...................................................................... 47
Calibrate the device ........................................................................................................................ 47
Change the battery ......................................................................................................................... 47
Clean the device .............................................................................................................................. 48
Specifications ........................................................................................ 51
Physical specifications .................................................................................................................. 51
Mechanical specifications ............................................................................................................ 51
Electrical specifications ................................................................................................................ 52
Environmental specifications ........................................................................................................ 52
Product disposal ............................................................................................................................. 53
Standards and compliance ................................................................... 55
General radio compliance ............................................................................................................. 55
Guidance and manufacturer's declaration .......................................... 57
Emissions and immunity information ........................................................................................... 57
Warranty ................................................................................................ 61
Troubleshooting ................................................................................... 63
Inaccurate blood pressure readings ........................................................................................... 63
Cuff inflation and deflation with no blood pressure reading displayed ................................. 64
No cuff inflation .............................................................................................................................. 64
Cuff pops off ..................................................................................................................................... 65
Cuff deflating too slowly ................................................................................................................ 65
Cuff inflates beyond SureBP inflation pressure preset while device is in use ..................... 65
Device does not turn on ................................................................................................................. 66
Bluetooth troubleshooting ............................................................................................................. 67
Directions for use Contents v
Appendix ................................................................................................ 69
ProBP 3400 approved accessories .............................................................................................. 69
Configuration options ..................................................................................................................... 72
Contents Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
vi
Initial device setup
Before using ProBP 3400 for the first time, you must configure the device for use. See Setup for
additional information.
1
Initial device setup Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
2
Introduction
This Directions for use manual is a comprehensive guide designed to help you understand the
capabilities and operation of the ProBP 3400 non-invasive blood pressure device. The information
in this manual includes all options available with the device. Read this manual thoroughly before
attempting to setup, configure, use, troubleshoot, or maintain the device.
Intended use
3
The ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and
pulse rate, as well as calculates Mean Arterial Pressure (MAP).
The device is intended to be used by clinicians and medically qualified personnel. It is available for
sale only upon the order of a physician or licensed health care provider.
Introduction Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
4
Symbols
Documentation symbols
Warning: The warning statements in this manual identify conditions or practices that could
lead to illness, injury, or death.
5
Power symbols
Caution: The caution statements in this manual identify conditions or practices that could
result in damage to the equipment or other property, or loss of data.
Consult operating instructions.
(green indicator) External power present,
battery charged
(amber indicator) External power present,
battery is charging
No external power present Battery charge level
Battery charging
Rechargeable battery
Button symbols
Power on/power off Return to previous screen
Blood Pressure Start/Stop Select
6
Symbols Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Navigation (Up, Down, Left, Right)
Shipping, storing, and environment symbols
Fragile; handle with care Relative humidity
limits
Temperature limits
Recovery/Recyclable Recycle the product
This end up Keep dry
IPXØ
Equipment is not protected against the ingress of
liquid
Connectivity symbols
Bluetooth® wireless technology enabled USB connection
Devices are connected via Bluetooth wireless
technology
Lithium-ion battery
separate from other
disposables
Bluetooth radio is
disabled or not paired
Miscellaneous symbols
Meets essential requirements of European Medical
Device Directive 93/42/EEC
Wireless radio alert in Europe. European
Communities Class 1 radio equipment.
Intertek ETL listed Type BF applied parts
Regulatory Affairs
Representative
EMC Framework of
Australia
Directions for use Symbols 7
Class II equipment Available for sale only
upon order of a physician
or licensed health care
provider
Serial number Manufacturer
Reorder number Call for maintenance
Non-ionizing electromagnetic radiation
Symbols Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
8
General warnings and cautions
WARNING The information in this directions for use is a comprehensive guide to
the operation of ProBP 3400. For best results, read this directions for use thoroughly
before using the device.
WARNING The device is designed for medical clinician use. Although this
directions for use may illustrate medical spot-check techniques, only a trained
clinician who knows how to take and interpret a patient's vital signs should use this
device.
9
WARNING The device is intended for use only in environments with clinician
supervision.
WARNING The device is not intended for continuous monitoring. Do not leave the
device unattended while taking measurements on a patient.
WARNING The device is not intended for use during patient transport.
WARNING Fire and explosion hazard. Do not operate the device in the presence
of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygenenriched environments; or in any other potentially explosive environment.
WARNING Use only Welch Allyn approved accessories. Use of unapproved
accessories with the device can affect patient and operator safety, and can reduce
product performance and accuracy. To ensure patient safety and optimal product
performance, use only accessories and supplies recommended for or supplied with
the device, and use according to the accessory manufacturer's directions for use.
WARNING Every three months, inspect the blood pressure cuff and other
accessories for fraying or other damage. Replace as necessary.
WARNING Inaccurate measurement risk. Do not use the device on patients who
are connected to heart/lung machines.
WARNING Electric shock hazard. Do not open the device or attempt repairs.
There are no user-serviceable parts inside ProBP 3400 other than battery
replacement. Only perform routine cleaning and maintenance procedures
specifically described in this directions for use. Inspection and servicing of internal
parts shall only be performed by qualified service personnel.
WARNING The device complies with applicable domestic and international
standards for electromagnetic interference and should not present problems to
other equipment or be affected by other devices. As a precaution, avoid using the
device in close proximity to other equipment.
10
General warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
WARNING Welch Allyn is not responsible for the integrity of any mounting
installation. Welch Allyn recommends that customers contact their Biomedical
Engineering Department or maintenance service to ensure professional installation
for safety and reliability of any mounting accessory.
WARNING The device is not defibrillator proof.
WARNING The device may not function properly if dropped or damaged. Do not
use the device if you notice any signs of damage. Qualified service personnel must
check any device that is dropped or damaged for proper operation before putting
the device back into use.
WARNING Defective batteries can damage the device. If the battery shows any
signs of damage, leakage, or cracking, it must be replaced immediately, and only
with a battery recommended for or supplied with the device.
WARNING Improper disposal of batteries may create an explosion or
contamination hazard. Never dispose of batteries in refuse containers. Do not
dispose of the battery in fire. Always recycle batteries according to local
regulations.
WARNING Improper handling of the battery can lead to heat generation, smoke,
bursting, or fire.
WARNING Do not remove the label from the battery.
WARNING Do not disassemble, modify, or solder the battery.
WARNING Do not directly connect or short circuit the positive (+) and negative (-)
battery terminals.
WARNING To avoid short circuits, keep battery terminals away from metal
objects.
WARNING Do not expose the battery to temperatures higher than 80 °C/176 °F.
WARNING If the accuracy of any measurement is in question, check the patient's
vital sign(s) with an alternate method and then check to verify the device is
functioning properly.
WARNING For proper patient electrical isolation and battery charging, use only
the provided external power supply to charge the device.
WARNING Electric shock hazard. Use the USB connector only to connect to
devices complying with IEC 60601-1 or other IEC standards as appropriate to the
device. The user is responsible for verifying that the system complies with the
requirements of the system standard IEC 60601-1-1 if additional devices are
connected to the ProBP 3400.
WARNING Electric shock hazard. Before cleaning the device, disconnect the
power cord from the power source and the device.
Caution Take care to prevent water or other fluid from entering any connectors
on the device. Should this occur, dry the connectors with warm air. Check the
accuracy of all operating functions.
Directions for use General warnings and cautions 11
Caution The device is not heat-resistant. Do not autoclave.
Caution Use the device within stated operating temperature ranges. The device
will not meet performance specifications if used outside these temperatures
ranges.
Caution Always unplug the external power source from the outlet before moving
the device to a new location.
General warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
12
NIBP warnings and cautions
WARNING ProBP 3400 is not intended to measure blood pressure on neonatal
patients. The AAMI SP10:2002 standard defines neonates as children 28 days or less
of age if born at term (37 weeks gestation or more); otherwise up to 44 gestational
weeks.
WARNING To ensure pediatric blood pressure accuracy and safety, the Small
Child Reusable Cuff (REUSE-08) and the Small Child Disposable Cuff (SOFT-08) are
the smallest cuffs approved for use with young children. The child's arm must fit
within the range markings on the cuff.
13
WARNING Do not compress the blood pressure hose or cuff. This may cause
system errors or patient safety risks to occur.
WARNING NIBP readings may be inaccurate for patients experiencing moderate
to severe arrhythmia.
WARNING Inaccurate measurement risk. Do not use the device on patients who
are experiencing convulsions or tremors.
WARNING Use only blood pressure cuffs and hoses listed as approved
accessories to ensure safe and accurate NIBP measurements.
WARNING Patient injury risk. When several blood pressure measurements are
taken on the same patient, regularly check the cuff site and extremity for possible
ischemia, purpura, and/or neuropathy.
WARNING Do not allow a blood pressure cuff to remain on the patient more than
3 minutes when inflated above 15 mmHg. Excessive cuff tightness may cause
venous congestion, peripheral nerve injury, discoloration of the limb, and patient
distress.
WARNING Inaccurate measurement risk. Do not place the cuff where it can
disturb proper circulation. Do not place the cuff on any area where circulation is
compromised or on any extremity used for intravenous infusions.
WARNING The blood pressure cuff must be properly positioned to ensure blood
pressure accuracy and patient safety. Wrapping the cuff too loosely (preventing
proper inflation) may result in inaccurate NIBP readings.
WARNING Patient injury risk. Never install Luer Lock connectors on Welch Allyn
blood pressure tubing. Using these connectors on blood pressure cuff tubing
creates the risk of mistakenly connecting this tubing to a patient's intravenous line
and introducing air into the patient's circulatory system.
14
NIBP warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
WARNING NIBP measurements may be inaccurate in the presence of excessive
motion artifact. Minimize extremity and cuff motion during blood pressure readings.
WARNING The position and physiologic condition of the subject can affect a
blood pressure reading.
WARNING If the blood pressure cuff is not at heart level, note the difference in
reading due to the hydrostatic effect. Add the value of .2 kPa (1.80 mmHg) to the
displayed reading for every 2.5 cm (inch) above heart level. Subtract the value of .2
kPa (1.80 mmHg) from the displayed reading for every 2.5 cm (inch) below heart
level.
WARNING Proper blood pressure cuff size and placement is essential to the
accuracy of the blood pressure determination. See Blood pressure cuff selection
for sizing information.
Contents checklist
Unpack the ProBP 3400 and any applicable accessories and inspect for missing items. Retain the
shipping materials in the event of shipping damage or for return, if necessary, to Welch Allyn for
repair or warranty service. Report any signs of shipping damage to the carrier. Report any missing
or damaged items to the Welch Allyn Service Center near you.
All ProBP 3400 devices include the following components:
ProBP 3400 Device. This device automatically measures systolic and diastolic pressure
(excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
15
Directions for Use CD. Read this Directions for Use thoroughly before using the ProBP 3400.
Save this CD for reference.
Battery. Install the battery before using the device. See Battery for additional information.
Blood Pressure Cuff(s). See Blood pressure hose and cuff for additional information.
Blood Pressure Hose. Latex-free pressure hose with connectors to attach various sizes of
blood pressure cuffs to the Welch Allyn ProBP 3400 device.
USB Cable. Attaches to Power Transformer and device to provide power to the ProBP 3400 and
charge the internal battery.
Power Transformer and Wall Plug/Line Cord. Power transformer and wall plug (or line
cord) assembles and attaches to USB cable to provide power to the ProBP 3400 and charge the
internal battery.
Welch Allyn Service Tool CD. The Welch Allyn Service Tool supports maintenance activities
on select Welch Allyn products.
Startup Guide. Use the Startup Guide to setup device for first-time use.
Warranty. Complete the ProBP 3400 warranty today at www.welchallyn.com/warranty.
Contents checklist Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
16
Controls and indicators
17
1. Power on/power off button: controls power to the device.
2. Blood Pressure Start/Stop button: initiates a new blood pressure cycle from the Home
screen. Pressing again aborts an active blood pressure measurement. This button returns user
to the Home screen from any other screen on the device.
3. Up navigation button: highlights the previous option in the Display window or increases
numeric values.
4. Return button: returns the user to the previous screen.
5. Right navigation button: highlights the Settings tab in the Display window or highlights
options to the right.
6. Charging LED: indicates when device is connected to external power and battery charging
state.
7. Down navigation button: highlights the next option in the Display window or decreases
numeric values.
8. Select button: selects list item that has been highlighted.
9. Left navigation button: highlights the Review tab in the Display window or highlights
options to the left.
Controls and indicators Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
18
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