Welch Allyn Connex® ProBP™ 3400 digital blood pressure device

Welch Allyn Connex® ProBP™
3400 digital blood pressure device
Directions for use
© 2016 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 Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any
use of such marks by Welch Allyn is under license.
Software in this product is Copyright 2016 Welch Allyn or its vendors. All rights are reserved. The
software is protected by United States of America copyright laws and international treaty provisions
applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software
incorporated with this instrument as intended in the operation of the product in which it is embedded.
The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced
to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title,
and ownership of the software remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, contact your local Welch Allyn representative http://
www.welchallyn.com/en/about-us/locations.html.
DIR 80020460 Ver. A
Revision date: 2016-01
This manual applies to
DEVICE
901055 DIGITAL BLOOD PRESSURE
Regulatory Affairs Representative
Welch Allyn, Inc.
4341 State Street Road
Welch Allyn Limited
Skaneateles Falls, NY 13153 USA
Dublin Road
www.welchallyn.com
Navan, County Meath
Navan Business Park
Republic of Ireland
iii
Contents
Initial device setup ................................................................................. 1
Introduction ............................................................................................. 3
Intended use ........................................................................................................ 3
Symbols ................................................................................................... 5
General warnings and cautions ............................................................. 9
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
vi
Contents
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
1
Initial device setup
Before using ProBP 3400 for the first time, you must configure the device for use. See
Setup for additional information.
2
Initial device setup
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
3
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
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.
This device is not intended for use on neonates, infants, or children under the age of 3
years. The effectiveness of this device has not been established in pregnant, including
pre-eclamptic, patients.
4
Introduction
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
5
Symbols
Documentation symbols
WARNING The warning statements in this manual identify conditions or practices that could lead to
illness, injury, or death.
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/directions for use (DFU).
A copy of the DFU is available on this website.
A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.
Power symbols
(green indicator) External power present, battery
charged
Battery charging
(amber indicator) External power present, battery is
charging
Rechargeable battery
No external power present
Battery charge level
Button symbols
Power on/standby
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
IPXØ
Fragile; handle with care
Relative humidity limits
Temperature limits
Lithium-ion battery
Recovery/Recyclable
Recycle the product
separate from other
disposables
This end up
Keep dry
Equipment is not protected against the ingress of liquid
Connectivity symbols
Bluetooth® wireless technology enabled
USB connection
Devices are connected via Bluetooth wireless technology
Bluetooth radio is disabled or
not paired
Miscellaneous symbols
Meets essential requirements of European Medical Device
Directive 93/42/EEC
Regulatory Affairs
Representative
Intertek ETL listed
EMC Framework of Australia
Class II equipment
Type BF applied parts
Directions for use
Symbols
Serial number
Available for sale only upon
order of a physician or
licensed health care provider
Reorder number
Manufacturer
Non-ionizing electromagnetic radiation
Call for maintenance
7
8
Symbols
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
9
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.
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 oxygen-enriched 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.
10
General warnings and cautions
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
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.
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 if additional devices are connected to the ProBP 3400.
Directions for use
General warnings and cautions
11
WARNING Electric shock hazard. Before cleaning the device, disconnect
the power cord from the power source and the device.
WARNING Electric shock hazard. No modification of this equipment is
allowed.
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.
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.
12
General warnings and cautions
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
13
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 This device is not intended for use on neonates, infants, or
children under the age of 3 years. The effectiveness of this device has not
been established in pregnant, including pre-eclamptic, patients.
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.
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.
14
NIBP warnings and cautions
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
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.
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.
WARNING Continuous cuff pressure due to connection tubing kinking
may result in blood flow interference and harmful injury may occur to the
patient.
WARNING Frequent measurements can cause injury to the patient due to
blood flow interference.
WARNING Do not place the cuff over a wound as this can cause further
injury.
WARNING Blood flow interference may result if the application of the cuff
and its pressurization on any limb where intravascular access or therapy, or
an arterio-venous (A-V) shunt is present and could result in injury to the
patient.
WARNING Avoid pressurizing a cuff on the arm side of a mastectomy.
WARNING Pressurization of the cuff may result in temporary loss of
function of simultaneous used monitoring equipment applied on the same
limb as the cuff.
WARNING The automated sphygmomanometer needs to be checked to
ensure that its operation does not result in prolonged impairment of blood
circulation of the patient.
15
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).
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.
16
Contents checklist
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
17
Controls and indicators
1. Power on/standby 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.
18
Controls and indicators
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
19
Screen elements
The liquid crystal display (LCD) may indicate any of the following: systolic blood pressure
(mmHg or kPa), diastolic blood pressure (mmHg or kPa), MAP (mmHg or kPa), pulse rate
(bpm), date, time, record number, and battery charge level.
Note
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Your model may not contain all of these options.
NIBP display: shows systolic and diastolic values of NIBP readings.
Bluetooth radio status (if equipped): indicates status of Bluetooth radio.
USB: indicates USB is connected.
Battery level indicator: displays the battery charge level.
Date: shows the current date.
Clock: shows the current time.
Reading number identified: shows what reading the device is on. The ProBP 3400
device retains up to 50 readings in memory.
MAP: shows the MAP value.
Settings: displays the Settings menu, when selected.
Review: displays the Review menu, when selected.
Pulse rate display: shows the pulse rate.
20
Screen elements
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
21
Connections
1.
2.
3.
4.
Mounting connection
Battery door screw
Blood pressure hose connection port
USB/external power cord connection port
22
Connections
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
23
Blood pressure hose and cuff
Identify and have available the ProBP 3400, blood pressure cuff, and the blood pressure
hose.
1. Inspect the blood pressure hose; notice that one end has a single, gray Welch Allyn
FlexiPort fitting and the other end is plain with two recessed holes.
2. Completely push the plain end of the blood pressure hose onto the two silver blood
pressure ports on the device. Make sure the hose is fully seated.
3. Snap the Welch Allyn FlexiPort connector onto the blood pressure cuff.
Blood pressure cuff selection
Careful sizing of the cuff is important for accurate blood pressure readings. If the cuff is
too small or too large, you may have false high or low readings, respectively. When there
is an area of overlap for using a smaller or larger cuff, use the larger size cuff.
The device uses oscillometric technology to determine blood pressure; therefore, if the
cuff extends to the antecubital fossa (bend in the elbow), you can still acquire an
accurate blood pressure reading.
Measure the arm circumference (midway between the elbow and shoulder) for the
correct cuff size.
Wrap the cuff around the patient’s upper arm and verify that the artery index marker falls
within the two divisions that identify the “range” on the cuff to indicate a proper fit.
The following table provides measurements for Welch Allyn blood pressure cuffs.
24
Blood pressure hose and cuff
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Cuff Size
Soft Disposable Reusable OneOne-Piece Cuff Piece Cuff
(20 per case)
(1 per pack)
Circumference
(cm)
Circumference (in)
Small child (size 8)
SOFT-08
REUSE-08
12.0 – 16.0
4.7 – 6.3
Child (size 9)
SOFT-09
REUSE-09
15.0 – 21.0
5.9 – 8.3
Small adult (size 10)
SOFT-10
REUSE-10
20.0 – 26.0
7.9 – 10.2
Adult (size 11)
SOFT-11
REUSE-11
25.0 – 34.0
9.8 – 13.4
Adult long (size 11L)
SOFT-11L
REUSE-11L
25.0 – 34.0
9.8 – 13.4
Large adult (size 12)
SOFT-12
REUSE-12
32.0 – 43.0
12.6 – 16.9
Large adult long (size 12L) SOFT-12L
REUSE-12L
32.0 – 43.0
12.6 – 16.9
Thigh (size 13)
REUSE-13
40.0 – 55.0
15.7 – 21.7
SOFT-13
For ordering information, see the ProBP 3400 approved accessories in the Appendix.
25
Power transformer
Power transformer and wall plug/line cord assembly
The power transformer and wall plug are packaged separately and must be assembled
prior to use. The power transformer assembles to a line cord for the mobile stand
configuration of the ProBP 3400.
1. Align the grooves in the wall plug or line cord with the casing located on the
transformer.
Ensure that the two prong plug on the wall plug or line cord and the plug receptacle
on the power transformer are aligned.
2. Slide the wall plug or line cord onto the transformer until it is firmly seated.
26
Power transformer
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Charge the device
Charge the ProBP 3400 with the Welch Allyn-supplied power supply.
To charge the device:
1. Insert the USB B connector into the USB/external power connection port on the back
of the device.
2. Insert the other end of the USB cord into USB connector on the power transformer,
then plug the transformer into the main power source.
27
Setup
Before first-time use of the ProBP 3400, complete the following steps:
Insert the battery
The battery is shipped separately from the ProBP 3400 device. You must install and
charge the battery for six hours before the device can be used.
1. Remove the screw from the battery compartment door with a Phillips screwdriver.
2. Remove the battery compartment door.
3. Remove the battery from the shipping bag.
4. Using the polarized guidelines on the battery label, insert the battery, positive (+)
side first, into the battery compartment.
5. Replace the battery compartment door.
6. Secure the screw with the screwdriver.
28
Setup
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Mount the device
For mounting instructions, see the accessory's directions for use.
For mounting options, see the ProBP 3400 approved accessories in the Appendix.
Assemble power cord and wall plug/line cord
1. Align the grooves and two prong plug in the wall plug or line cord with the casing
and plug receptacle located on the transformer.
2. Slide the wall plug or line cord onto the transformer until it is firmly seated.
Charge the ProBP 3400
To charge the device:
1. Insert the USB B connector into the USB/external power connection port on the back
of the device.
2. Insert the other end of the USB cord into USB connector on the power transformer,
then plug the transformer into the main power source.
Initial startup
To complete initial configuration, you must turn on the device, and select an operating
language, date, and time.
1. Press the Power on/power off button. After device power up, the display window
shows the Language screen.
2. Use the Up and Down navigation buttons to highlight the correct option.
3. Press the Select button to choose a language. A confirmation window displays your
language selection.
Set date and date format
After you select a language, set the device Date and Date format:
1. The Date format field is highlighted. Press the Up navigation or Down navigation
buttons to access the correct format option.
2. Press the Select button to accept the date format as shown.
3. Press the Down navigation button to highlight the date.
4. Press the Select button. The first numeric field is highlighted for editing.
5. Use the Up navigation button to increase the number value; use the Down
navigation button to decrease the number value.
6. Press the Right navigation button to move to the next field.
7. Repeat steps 5 and 6 to edit additional numeric values.
8. Press the Right navigation button to highlight the OK button.
9. Press the Select button to accept the date as shown.
10. Press the Down navigation button to highlight the Next button.
11. Press the Select button to move to the Time and Time format screen.
Directions for use
Setup
29
Set time and time format
1. The Time format field is highlighted. Press the Up navigation or Down navigation
buttons to access the correct format option.
2. Press the Select button to accept the time format as shown.
3. Press the Down navigation button to highlight the time.
4. Press the Select button. The first numeric field is highlighted for editing.
5. Use the Up navigation button to increase the number value; use the Down
navigation button to decrease the number value.
6. Press the Right navigation button to move to the next field.
7. Repeat steps 5 and 6 to edit additional numeric values.
8. Press the Right navigation button to highlight the OK button.
9. Press the Select button to accept the entry.
10. Press the Down navigation button to highlight the Next button.
11. Press the Select button to complete the Setup process. The device will display the
Home screen.
30
Setup
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
31
Battery
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 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.
The ProBP 3400 device is powered by a lithium-ion rechargeable battery.
The battery is shipped separately from the ProBP 3400 device. You must install and
charge the battery for six hours before using the device.
To install the battery:
1. Remove the screw from the battery compartment door with a Phillips screwdriver.
2. Remove the battery compartment door.
3. Remove the battery from the shipping bag.
32
Battery
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
4. Using the polarized guidelines on the battery label, insert the battery, positive (+)
side first, into the battery compartment.
5. Replace the battery compartment door.
6. Secure the screw with the screwdriver.
The battery charges when the ProBP 3400 is connected to an external power source.
While the ProBP 3400 is charging, the
symbol displays an amber indicator and the
battery charging indicator,
, displays on the Home screen. The battery charging
indicator is only visible when the device is powered on. When the battery is charged, the
symbol displays a green indicator, and the battery level indicator is steady with all
segments continuously shown on the Home screen. An operator can use the device
while the battery is charging; however, the battery charges faster when the instrument
is not in operation.
A dead battery may result if the ProBP 3400 is left uncharged or unused for a long period
of a time. If this occurs, charge the battery by connecting the ProBP 3400 to an external
power source. Charge the battery for at least six hours before disconnecting the device
from the power supply.
If the ProBP 3400 will be unused for several months or longer, remove the battery prior
to storing the device.
33
Startup
Press the Power on/power off button to turn the device on or off. Upon each power up,
the display lights up and the ProBP 3400 displays the model number. When the internal
self-check completes, the display shows the Home screen with all values blank, and the
device is ready for operation.
If disconnected from an external power source, the ProBP 3400 automatically powers off
when not used for 30 minutes. When the device is connected to external power, the
device will automatically power off after three hours of non-use.
Note
These automatic power-off times are adjustable through the Welch Allyn
Service Tool software, which is provided with each device.
If a system error is detected, the device displays a system fault message that contains a
wrench icon
and a system fault code to assist service and engineers in diagnosing
the problem.
34
Startup
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
35
Standby mode
The standby mode conserves battery power. The display goes black, then enters
standby mode two minutes after a reading or last button pressed.
Press any button to bring the ProBP 3400 out of Standby Mode.
If disconnected from an external power source, the ProBP 3400 automatically powers off
when not used for 30 minutes. When the device is connected to external power, the
device will automatically power off after three hours of non-use.
Note
These automatic power-off times are adjustable through the Welch Allyn
Service Tool software, which is provided with each device.
36
Standby mode
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
37
Blood pressure measurement
The preferred blood pressure measurement site for adults and children is the upper arm.
Keep the patient’s arm relaxed and motion-free during measurement(s). The patient
should be seated and relaxed for 5 minutes prior to the blood pressure measurement.
The patient should also be comfortably seated, legs uncrossed, feet flat on the floor,
back and arm supported. The middle of the cuff should be at the level of the heart. The
patient should not talk during the measurement.
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 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 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 This device is not intended for use on neonates, infants, or
children under the age of 3 years. The effectiveness of this device has not
been established in pregnant, including pre-eclamptic, patients.
To initiate blood pressure measurements:
1. Press the Power on/power off button to turn the device on.
2. Properly size the blood pressure cuff and position it around the patient's bare upper
arm with the artery index marker over the brachial artery. Leave room between the
cuff and the arm for no more than two fingers.
3. From the Home screen, press the Blood Pressure Start/Stop button.
The ProBP 3400 inflates the blood pressure cuff to the appropriate pressure and
displays the pressure as the blood pressure cuff is deflating.
If your device contains the SureBP feature (captures blood pressure on inflation):
From the Home screen, press the Blood Pressure Start/Stop button. The ProBP
38
Blood pressure measurement
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
3400 inflates the cuff to the appropriate level, measuring the blood pressure as the
cuff is inflating. The systolic display shows the pressure in the cuff as the blood
pressure determination is in process. If the device is unable to determine a blood
pressure while the cuff is inflating due to patient movement, excessive noise, or an
arrhythmia, the device will use the Step algorithm to inflate the cuff to a higher
pressure, then attempt to measure the blood pressure while deflating the cuff.
Pressing the Blood Pressure Start/Stop button at any time during a blood pressure
determination aborts the measurement and rapidly deflates the cuff.
When complete, the ProBP 3400 device displays systolic, diastolic, pulse rate
measurements, and if enabled, MAP calculation.
39
Settings
1. From the Home screen, press the Right navigation button. Settings is highlighted.
2. Press the Select button. The Settings menu displays.
3. Use Up or Down navigation buttons to highlight the Unit of measure, Pressure
preset, Bluetoothradio, or Advanced menus.
Note
The Bluetooth radio menu option is only visible for devices
that contain the Bluetooth licensed feature. The NIBP
algorithm is only visible for devices that contain the SureBP
licensed feature.
Settings matrix
Settings >
Unit of measure
Pressure presets
Bluetooth radio
Advanced >
Cycle count
Data management
Date
Time
MAP
NIBP algorithm
Language
Unit of measure
To select a unit of measure:
1. From the Settings screen, use Up or Down navigation buttons to highlight Unit of
measure.
2. Press the Select button. The Unit of measure menu displays.
3. Use Up or Down navigation buttons to highlight mmHg or kPa.
40
Settings
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
4. Press the Select button to select the unit of measure.
The default unit of measure is mmHg.
Pressure presets
To select a pressure preset:
1. From the Settings screen, use Up or Down navigation buttons to highlight
Pressure presets.
2. Press the Select button. The Pressure presets menu displays.
3. Use Up or Down navigation buttons to highlight desired pressure.
4. Press the Select button to select the pressure.
The default inflation pressure is 160 mmHg or 21.3 kPa.
Bluetooth wireless technology
To wirelessly transfer data from the ProBP 3400 to another device with Bluetooth
technology, you must enable Bluetooth technology in both devices, then pair and
connect the devices. Pairing will create a unique wireless link between two Bluetooth
wireless technology enabled devices.
The default setting for Bluetooth radio is Enable.
Enable Bluetooth radio and pair devices
When trying to pair the ProBP 3400 with a target device, keep the devices within several
meters or feet of each other.
To enable the Bluetooth radio and pair your Bluetooth wireless technology-enabled
devices:
1. From the Settings screen, use Up or Down navigation buttons to highlight
Bluetooth radio.
2. Press the Select button.
3. Use the Up or Down navigation buttons to highlight Enable.
4. Press the Select button to confirm your selection.
5. Press the Down navigation button to highlight the Pair button.
6. Press the Select button to place the ProBP 3400 into Pairing mode.
7. Activate the Bluetooth feature on your target device and search for the ProBP 3400.
Consult your target device's user manual for device-specific instructions.
8. Select the ProBP 3400 from the list of devices found by your target device.
9. Enter the PIN (1234) to pair the ProBP 3400 to your target device.
The ProBP 3400 supports the Secure Simple Pairing feature, which allows the device
to be paired to a target device without requesting a PIN. This feature is available for
target devices that are compliant with Bluetooth version 2.1 or higher.
10. When pairing is complete, the ProBP 3400 will automatically connect to your target
device and will attempt to reconnect to your target device each time the ProBP 3400
is powered on.
Directions for use
Settings
When devices are connected, the
3400 screen.
41
symbol appears in the left corner of the ProBP
Connect the ProBP 3400 to a target device
When the ProBP 3400 is paired to a target device, it will attempt to automatically
reconnect each time you turn on the ProBP 3400. If the devices do not connect within
60 seconds of turning on the ProBP 3400, the Bluetooth radio will shut down to
conserve battery power.
If the ProBP 3400 does not automatically reconnect,
1. Press the Power on/power off button to turn the device off.
2. Ensure that you are within several meters or feet of the target device.
3. Press the Power on/power off button to turn the device on.
Advanced settings
To view or modify advanced settings:
1. From the Settings screen, press the Up or Down navigation buttons to highlight
the Advanced menu.
2. Press the Select button. The Advanced menu displays.
3. Use Up or Down navigation buttons to highlight the Cycle count, Data
management, Date, Time, MAP or Language screens.
Cycle count
To view device cycle count:
1. From the Advanced screen, use Up or Down navigation buttons to highlight Cycle
count.
2. Press the Select button. The total number or readings taken on the device displays.
3. Use the Down navigation button to highlight Close.
Data management
The ProBP 3400 is able to store up to 50 readings in its internal memory. The Data
management function allows you to manage how additional readings are stored.
1. From the Advanced screen, use Up or Down navigation buttons to highlight Data
management.
2. Press the Select button.
3. Use the Up or Down navigation buttons to highlight Auto overwrite or Ask
overwrite.
If Auto overwrite is selected, the device will overwrite previous readings, starting
with Reading 1, once internal memory is full. If Ask overwrite is selected, the user
will have to confirm the save of each additional reading once the memory is full.
4. Press the Select button to confirm your choice.
The default data management setting is Auto overwrite.
42
Settings
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Select date
To modify the date shown on the Home screen:
1. From the Advanced screen, use Up or Down navigation buttons to highlight Date.
2. Press the Select button to edit the entry.
3. The Date format field is highlighted. Press the Up navigation or Down navigation
buttons to access the correct format option.
4. Press the Select button to accept the date format as shown.
5. Press the Down navigation button to highlight the date.
6. Press the Select button. The first numeric field is highlighted for editing.
7. Use the Up navigation button to increase the number value; use the Down
navigation button to decrease the number value.
8. Press the Right navigation button to move to the next field.
9. Repeat steps 7 and 8 to edit additional numeric values.
10. Press the Right navigation button to highlight the OK button.
11. Press the Select button to accept the entry.
Select time
To modify the time shown on the Home screen:
1. From the Advanced screen, use Up or Down navigation buttons to highlight Time.
2. Press the Select button to edit the entry.
3. The Time format field is highlighted. Press the Up navigation or Down navigation
buttons to access the correct format option.
4. Press the Select button to accept the time format as shown.
5. Press the Down navigation button to highlight the time.
6. Press the Select button. The first numeric field is highlighted for editing.
7. Use the Up navigation button to increase the number value; use the Down
navigation button to decrease the number value.
8. Press the Right navigation button to move to the next field.
9. Repeat steps 7 and 8 to edit additional numeric values.
10. Press the Right navigation button to highlight the OK button.
11. Press the Select button to accept the entry.
MAP
1. From the Advanced screen, use Up or Down navigation buttons to highlight MAP.
2. Press the Select button.
3. Use the Up or Down navigation button to highlight On or Off.
4. Press the Select button to confirm your choice.
The default MAP setting is On.
Directions for use
Settings
43
NIBP algorithm
To modify the NIBP algorithm used on the device:
1. From the Advanced screen, use Up or Down navigation buttons to highlight NIBP
algorithm.
2. Press the Select button to edit the entry.
3. Use the Up or Down navigation buttons to highlight SureBP or Step.
4. Press the Select button to accept the entry as shown.
If SureBP is selected, the device inflates the cuff to the appropriate level, measuring
the blood pressure as the cuff is inflating. The systolic display shows the pressure in
the cuff as the blood pressure determination is in process. If Step is selected, the
device will inflate the cuff, then measure the blood pressure while deflating the cuff.
If the device is unable to determine a blood pressure while the cuff is inflating due to
patient movement, excessive noise, or an arrhythmia, the device will use the Step
algorithm to inflate the cuff to a higher pressure, then attempt to measure the blood
pressure while deflating the cuff.
The default NIBP algorithm is SureBP.
Language
To change device language:
1. From the Advanced screen, use Up or Down navigation buttons to highlight
Language.
2. Press the Select button. The Language screen displays.
3. Use the Up or Down navigation buttons to highlight the correct Language option.
4. Press the Select button to choose a language.
A popup confirmation screen will display your language selection.
The default language is English.
44
Settings
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
45
Data review
Data is accessed through the Review menu. Data can be identified by number, date,
time reading was taken, diastolic/systolic parameters, MAP, and pulse rate data captured
at the time of the reading.
Review data
1. From the Home screen, press the Left navigation button. The Review menu option
is highlighted.
2. Press the Select button. Review menu displays.
3. Use Up or Down navigation buttons to review the desired reading.
Delete data
1. From the Home screen, press the Left navigation arrow. The Review menu option
is highlighted.
2. Press the Select button. Blood pressure, pulse rate, MAP data (if enabled), date, and
time displays.
3. Use Up or Down navigation buttons to highlight desired reading.
4. Press the Select button to delete selected reading. A popup confirmation screen will
appear; use Up or Down navigation buttons to highlight deletion of the selected
reading, deletion of all readings, or to exit the screen without saving changes.
5. Press the Select button to confirm deletion of selected or all readings or press the
Blood Pressure Start/Stop button to exit without saving your changes.
46
Data review
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
47
Maintenance and service
Calibrate the device
Verify device calibration annually using the Welch Allyn Service Tool. If your device is out
of calibration, contact your nearest Welch Allyn Service Center.
Change the battery
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 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.
The ProBP 3400 device is powered by a lithium-ion rechargeable battery.
48
Maintenance and service
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
To remove the battery:
1. Remove the screw from the battery compartment door with a Phillips screwdriver.
2. Remove the battery compartment door.
3. Remove the battery from the battery compartment.
4. Remove the new battery from the shipping bag.
5. Using the polarized guidelines on the battery label, insert the battery, positive (+)
side first, into the battery compartment.
6. Replace the battery compartment door.
7. Secure the screw with the screwdriver.
If the ProBP 3400 will be unused for a long period of time, remove the battery prior to
storing the device.
Clean the device
WARNING Electric shock hazard. Before cleaning the device, disconnect
the power cord from the power source and the device.
WARNING 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.
CAUTION The device is not heat-resistant. Do not autoclave.
The following agents are compatible with the device:
•
70 percent isopropyl alcohol
•
10 percent chlorine bleach/90 percent water solution
Note
Clean the device on a routine basis, according to your facility's protocols
and standards or local regulations.
70 percent isopropyl alcohol
Wipe the device with a clean cloth slightly dampened with 70 percent isopropyl alcohol.
Directions for use
Maintenance and service
10 percent chlorine bleach/90 percent water solution
1. Wipe the device with a clean cloth slightly dampened with a 10 percent bleach and
90 percent water solution.
2. Rinse with a clean cloth slightly dampened with clean water.
3. Allow the device surface to dry for a minimum of 10 minutes before using the
device.
Clean the accessories
Wipe the NIBP hose and any reusable cuffs with a damp cloth moistened in a mild
detergent solution.
The same cleaning agents used to clean the device can be used on the stand and
mounting accessories.
Note
Clean the device on a routine basis, according to your facility's protocols
and standards or local regulations.
49
50
Maintenance and service
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
51
Specifications
Physical specifications
Performance
This section describe normal ranges for the ProBP 3400 device.
Blood Pressure Accuracy
Blood pressure accuracy meets or exceeds ANSI.AAMI SP10:2002 standards for
noninvasive blood pressure accuracy (±5 mmHg mean error, 8 mmHg standard
deviation). Blood pressure accuracy is validated for pressure measurement using the
upper arm only.
Cuff pressure range
0 to 300 mmHg
Systolic range
60 to 250 mmHg
Diastolic range
30 to 160 mmHg
Mean Arterial Pressure (MAP) range
MAP is a calculated reading that yields an approximate value.
40 to 190 mmHg
Pulse rate range
35 to 199 bpm
Pulse rate accuracy
±5.0%
Overpressure cutoff
300 mmHg
Mechanical specifications
Dimensions
Height: 15.0 cm (5.91 inches)
Width: 8.0 cm (3.15 inches)
Depth: 5.6 cm (2.20 inches)
Weight
450 g (0.99 lb)
Mounting
Custom mobile stand
Custom wall mount
Custom desk mount
Portability
May be used as a handheld device
52
Specifications
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Electrical specifications
Power requirements:
Input: 100-240VAC, 0.18A, 50-60Hz
Output: 5VDC, 0.5A
Degree of protection:
Type BF applied part
Safety classification:
Class II
Internally powered:
Battery, lithium-ion type, 3.7V, 2100mAh, 7.8Wh
Protection against the ingress of water:
IPXØ
Safety mode of operation:
Continuous operation
Standards:
This device complies with the following standards:
EN/IEC 60601-1
EN/IEC 60601-1-2
EN/IEC 80601-2-30
EN 1060-1:1996 Specification for non-invasive sphygmomanometers Part 1: General requirements
EN 1060-3:1997 Specification for non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
FCC Subpart 15C
FCC ID #PI4411B, IC 1931B-BTM411
Environmental specifications
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 oxygen-enriched environments; or in any other potentially
explosive environment.
CAUTION Use the device within stated operating temperature ranges. The
device will not meet performance specifications if used outside these
temperatures ranges.
Operating temperature
10°C to 40° C (50° to 104° F)
Storage temperature
-20°C to 50° C (-4° to 122° F)
Operating altitude
-170 to 4877 m (-557 to 16,000 ft.)
Storage humidity
15 to 95% (noncondensing)
Directions for use
Specifications 53
Product disposal
Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted
municipal waste.
54
Specifications
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
55
Standards and compliance
General radio compliance
The Bluetooth Wireless Card must be used in strict accordance with the manufacturer’s
instructions as described in the user documentation that comes with the product.
This device complies with Part 15 of the FCC rules and with the rules of the Canadian
ICES-003. Operation is subject to the following two conditions: (1) This device may not
cause harmful interference and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Federal Communications Commission (FCC)
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:
•
This device may not cause harmful interference.
•
This device must accept any interference received, including interference that may
cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy. If not installed and
used in accordance with the instructions, it may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try and correct the interference by one or more of the following
measures:
•
Reorient or relocate the receiving antenna
•
Increase the distance between the equipment and the receiver
•
Connect the equipment to an outlet on a circuit different from that to which the
receiver is connected
•
Consult the dealer or an experienced radio/TV technician for help
The user may find the following booklet prepared by the Federal Communications
Commission helpful:
The Interference Handbook
56
Standards and compliance
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
This booklet is available from the U.S. Government Printing Office, Washington, D.C.
20402. Stock No. 004-000-0034504.
Welch Allyn is not responsible for any radio or television interference caused by
unauthorized modification of the devices included with this Welch Allyn product, or the
substitution or attachment of connecting cables and equipment other than specified by
Welch Allyn.
The correction of interference caused by such unauthorized modification, substitution, or
attachment will be the responsibility of the user.
Industry Canada (IC)
This device complies with RSS 210 of Industry Canada.
Operation is subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including interference that
may cause undesired operation of this device.
L’utilisation de ce dispositif est autorisée seulement aux conditions suivantes: (1) il ne
doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter
tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de
compromettre le fonctionnement du dispositif.
This Class B digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada.
European Union
The Bluetooth radio contained within this equipment complies with the essential
requirements of the European Union R&TTE Directive (1999/5/EC).
57
Guidance and manufacturer's declaration
Emissions and immunity information
Electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or user of the device
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
The device is suitable for use in all establishments other than domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
WARNING This equipment/system is intended for
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment a. It
may be necessary to take mitigation measures, such
as re-orienting or relocating the device or shielding
the location.
a The device contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency hopping
spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according to the
requirements of various agencies, including FCC 47 CFR 15.247 and R&TTE Directive (1995/5/EC). The transmitter is
excluded from the EMC requirements of 60601-1-2:2007, but should be considered when addressing possible
interference issues between this and other devices.
58
Guidance and manufacturer's declaration
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge ±6 kV contact
(ESD)
± 8 kV air
IEC 61000-4-2
± 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 Mains power quality should be that of a typical
lines
commercial or hospital environment.
±1 kV for input/output
lines
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV differential
mode
± 2 kV common mode
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
>95% dip in 0.5 cycle
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
60% dip in 5 cycles
60% dip in 5 cycles
of the device requires continued operation
30% dip for 25 cycles 30% dip for 25 cycles during power mains interruptions, it is
>95% dip in 5 seconds >95% dip in 5 seconds recommended that the device be powered from
an uninterruptible power supply or a battery.
>95% dip in 0.5 cycle
Electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliancelevel
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz to 1 GHz 3 V/m
d= (1.17)
d= (1.17)
80 to 800 MHz
d= (2.33)
800 MHz to 2,5 GHz
whereP is the maximum output power rating of
the transmitter in watts (W) andd is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
Directions for use
Guidance and manufacturer's declaration 59
Electromagnetic immunity
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:
Note1: 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.
aField 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 device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.
bOver 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 device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the device as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
Rated max. output
power of transmitter d= (1.17)
(W)
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d= (1.17)
d= (2.23)
0.01
0.11667
0.11667
0.23333
0.1
0.36894
0.36894
0.73785
1
1.1667
1.1667
2.3333
10
3.6894
3.6894
7.3785
100
11.667
11.667
23.3333
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, whereP 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.
60
Guidance and manufacturer's declaration
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
61
Warranty
Welch Allyn will warranty the ProBP 3400 device and battery to be free of defects in
material and workmanship and to perform in accordance with manufacturer
specifications for the period of one year from the date of purchase from Welch Allyn or
its authorized distributors or agents.
The warranty period shall start on the date of purchase. The date of purchase is: 1) the
invoiced ship date if the device was purchased directly from Welch Allyn, 2) the date
specified during product registration, 3) the date of purchase of the product from a
Welch Allyn authorized distributor as documented from a receipt from said distributor.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.
The product warranty is also subject to the following terms and limitations:
Accessories are not covered by the warranty. Refer to the Directions For Use provided
with individual accessories for warranty information.
Shipping cost to return a device to a Welch Allyn Service center is not included.
A service notification number must be obtained from Welch Allyn prior to returning any
products or accessories to Welch Allyn's designated service centers for repair. To obtain
a service notification number, contact Welch Allyn Technical Support.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT
OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT
DEFECT COVERED BY THE WARRANTY.
62
Warranty
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
63
Troubleshooting
Inaccurate blood pressure readings
Possible cause
Corrective action and explanation
Incorrect cuff size
Use Welch Allyn approved cuffs only.
Measure patient’s arm circumference midway between
elbow and shoulder (see “Blood pressure cuff selection” to
select correct cuff size).
Patient’s arm position
Ensure patient’s arm is at heart level.
Arm movement during blood pressure cycle
Keep arm still during blood pressure cycle.
Movement may cause inaccuracies from artifact.
Blood pressure taken over clothing
Take blood pressure on a bare arm.
Arrhythmia
Check for regularity of heart rate (palpate pulse or check
device).
Moderate to severe heart rate irregularities may make
blood pressure difficult to measure accurately.
Change in blood pressure between auscultatory reading
and ProBP 3400 reading
Check blood pressure immediately before ProBP 3400
reading.
Blood pressure is dynamic and changing. It is normal for
blood pressure to fluctuate 5 to 10 mmHg.
Incorrect reference
Use the correct Korotkoff sound to determine diastolic
blood pressure.
• Many listeners incorrectly equate diastolic blood
pressure with the disappearance of sound only (phase
5). ProBP 3400 was developed using the American
Heart Association recommendations, which state that
phase 5 be used unless sound continues to 0 mmHg,
in which case the change in the quality of sound
(phase 4) is to be used.
Deflate cuff no faster than 3 mmHg per second.
• One of the major sources of error in auscultatory
blood pressure measurement is deflating the cuff too
64
Troubleshooting
Possible cause
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Corrective action and explanation
quickly. The American Heart Association recommends
deflation no faster than 3 mmHg per second.
Only use a sphygmomanometer that is calibrated.
• An uncalibrated sphygmomanometer may result in
inaccurate blood pressure measurements.
Poor auscultatory sound recognition by observer
Use high-quality stethoscope. Have a different observer
check patient’s blood pressure.
Cuff inflation and deflation with no blood pressure reading
displayed
Possible cause
Corrective action and explanation
Leak in pneumatic system
Inflation too quick; check NIBP cuff and tubing
connections may display.
Cuff pressure limits exceeded. Powering down may
display.
NIBP air leak; check cuff and tubing connections may
display.
Unable to determine NIBP; check inflation settings
may display.
Ensure all cuff attachments are tight.
Carefully check for leaks in the blood pressure cuff, tubing,
and pressure hose attached to ProBP 3400.
Arm movement during cycle
Unable to determine NIBP; check connections; limit
patient movement may display.
Keep arm still during blood pressure cycle.
Movement may cause inaccuracies from artifact, long cycle
times, and error message.
Cuff tubing or pressure hose movement artifact
Unable to determine NIBP; check connections and
tubing for kinks may display.
Do not contact cuff tubing or pressure hose during blood
pressure cycle.
Movement may cause inaccuracies from artifact.
User may have pressed the Blood Pressure Start/ User cancelled NIBP reading will display. Press the
Stop button
Blood Pressure Start/Stop button to initiate
blood pressure measurement.
No cuff inflation
Possible cause
Corrective action and explanation
Connections between device and cuff loose
Check all connections.
Directions for use
Troubleshooting
Possible cause
Corrective action and explanation
Device is being used in inclimate environment
Ambient temperature is outside of operating range.
Retry measurement may display.
Operate the device within temperature range in the
Environmental specifications section.
Internal errors or messaging error occurred
NIBP feature not functional. Call for service may
display.
Contact a Welch Allyn Service Center.
65
Cuff pops off
Possible cause
Corrective action and explanation
Inappropriate cuff size
See “Blood pressure cuff selection” to select correct cuff
size. If cuff continues to pop off, notify biomedical
department or Welch Allyn Technical Support.
Cuff not applied securely
Smooth hook and loop securely before inflating cuff.
Cuff applied inside out
Re-apply cuff. Verify that the Welch Allyn label is facing
away from arm.
Cuff deflating too slowly
Possible cause
Corrective action and explanation
Patient movement
Have patient sit still.
Do not have arm tight against chest wall, as respiration
may affect speed and accuracy of blood pressure
measurement.
Arrhythmia
Check for regularity of heart rate (palpate pulse or check
device).
Moderate to severe heart rate irregularities may make
blood pressure difficult to measure accurately.
Small leak in pneumatic system
Check cuff tubing and pressure hose for leaks.
Cuff inflates beyond SureBP inflation pressure preset
while device is in use
Possible cause
Corrective action and explanation
Device switched from SureBP to Step algorithm
If the device is unable to determine a blood pressure while
the cuff is inflating due to patient movement, excessive
noise, or an arrhythmia, the device will use the Step
66
Troubleshooting
Possible cause
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Corrective action and explanation
algorithm to inflate the cuff to a higher pressure, then
attempt to measure the blood pressure while deflating the
cuff.
Arm movement during blood pressure cycle
Keep arm still during blood pressure cycle.
Movement may cause inaccuracies from artifact.
Blood pressure taken over clothing
Take blood pressure on a bare arm.
Arrhythmia
Check for regularity of heart rate (palpate pulse or check
device).
Moderate to severe heart rate irregularities may make
blood pressure difficult to measure accurately.
Device does not turn on
Possible cause
Corrective action and explanation
Low battery
Plug in the device. Check connections between the ProBP
3400 and the transformer, then between the transformer
and wall receptacle.
Battery installed incorrectly
Using the polarized guidelines on the battery label, insert
the battery, positive (+) side first, into the battery
compartment.
Device not powering up
Unplug the device from wall receptacle and check for
breaks in the cord. If connections are secure, check
electrical outlet for power. Charging indicator is on if
connections are good and the device is plugged into a
working outlet.
Plug the device into a known working electrical outlet.
The device may not power up if the battery is completely
discharged. Connect the device to an external power source
for at least 15 minutes before attempting to power up
again. If device powers up, charge the battery for at least
six hours before disconnecting the device from the power
supply.
Replace the battery.
Notify Biomedical department or Welch Allyn Technical
Support.
System error
The device displays a system fault message that contains a
wrench icon
and a system fault code to assist service
and engineers in diagnosing the problem.
Directions for use
Troubleshooting
Bluetooth troubleshooting
ProBP 3400 and the target device will not pair
Possible cause
Corrective action and explanation
Bluetooth radio is not enabled on the ProBP 3400
See Bluetooth wireless technology section for instructions
on enablingBluetooth functionality in the device.
ProBP 3400 is not in Pairing mode
See Bluetooth wireless technology section for instructions
on enabling pairing in the device.
There is too much distance between ProBP 3400 and the
target device
Move the ProBP 3400 closer to the target device.
The wrong PIN was entered for a Bluetooth 2.0 connection If a PIN is requested, enter 1234.
There is a problem with the target device
Refer to operating system or computer hardware manuals
for further troubleshooting.
ProBP 3400 and the target device are not connected
Possible cause
Corrective action and explanation
ProBP 3400 and the target device have not been paired.
Follow instructions for pairing the ProBP 3400 to a target
device.
If pairing was attempted:
• Complete pairing process again
• See troubleshooting section for ProBP 3400 and the
target device will not pair.
There is too much distance between ProBP 3400 and the
target device
Move the ProBP 3400 closer to the target device.
The target device and/or software were not launched in the The connection process was not completed in the correct
correct order
order.
1. Exit the application on the computer.
2. Power down, then power up ProBP 3400.
3. Relaunch the computer application.
There is a problem with the target device
Refer to operating system or computer hardware manuals
for further troubleshooting.
ProBP 3400 and the target device lost connection
Possible cause
Corrective action and explanation
Unexpected loss in Bluetooth communication
1.
Exit the target application.
67
68
Troubleshooting
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Possible cause
Corrective action and explanation
The ProBP 3400 powered down
2.
3.
4.
There is too much distance between ProBP 3400 and the
target device
Move the ProBP 3400 closer to the target device.
There is a problem with the target device
Refer to operating system or computer hardware manuals
for further troubleshooting.
Power down the ProBP 3400
Restart the ProBP 3400
Relaunch the target application.
69
Appendix
ProBP 3400 approved accessories
Flexiport® cuffs (not made with natural rubber latex)
Part Number
Model
Description
REUSE-08
Reusable
Cuff, reuse, SM CHILD
REUSE-09
Reusable
Cuff, reuse, CHILD
REUSE-10
Reusable
Cuff, reuse, SM ADULT
REUSE-11
Reusable
Cuff, reuse, ADULT
REUSE-11L
Reusable
Cuff, reuse, ADULT LONG
REUSE-12
Reusable
Cuff, reuse, LG ADULT
REUSE-12L
Reusable
Cuff, reuse, LG ADULT LONG
REUSE-13
Reusable
Cuff, reuse, THIGH
SOFT-08
Disposable
Cuff, soft, SM CHILD (case of 20)
SOFT-09
Disposable
Cuff, soft, CHILD (case of 20)
SOFT-10
Disposable
Cuff, soft, SM ADULT (case of 20)
SOFT-11
Disposable
Cuff, soft, ADULT (case of 20)
SOFT-11L
Disposable
Cuff, soft, ADULT LONG (case of 20)
SOFT-12
Disposable
Cuff, soft, LG ADULT (case of 20)
SOFT-12L
Disposable
Cuff, soft, LG ADULT LONG (case of 20)
SOFT-13
Disposable
Cuff, soft, THIGH (case of 20)
70
Appendix
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Blood pressure accessories (not made with natural rubber latex)
Part Number
Model
Description
3400-30
ProBP 3400
Double tube blood pressure hose (5 ft)
3400-31
ProBP 3400
Double tube blood pressure hose (10 ft)
Mounting options
Part Number
Description
4600-61
Mobile stand with basket and mounting kit for ProBP 3400
4601-61
Wall mount with basket for ProBP 3400
4602-61
Desk mount for ProBP 3400
Accessories and replacement parts
Part Number
Description
BATT11
Lithium Ion battery, 1 Cell
3400-925
ProBP 3400 USB cable, 2.44 m (8 ft)
3400-926
ProBP 3400 USB cable, 0.30 m (16 inches)
4600-100
5W power supply mounting kit (for use with mobile stand)
3400-561
ProBP 3400 basket adapter with screw
3400-461
ProBP 3400 wall adapter with screw
PWCD-5WW-B
Power cord assembly, for handheld, or desk or wall mounted
ProBP 3400, North America
PWCD-5WT-B
Power cord assembly B, for mobile stand mounted ProBP 3400,
North America
PWCD-5WW-2
Power cord assembly 2, for handheld, or desk or wall mounted
ProBP 3400, Europe
PWCD-5WT-2
Power cord assembly 2, for mobile stand mounted ProBP 3400,
Europe
PWCD-5WW-4
Power cord assembly 4, for handheld, or desk or wall mounted
ProBP 3400, United Kingdom
PWCD-5WT-4
Power cord assembly 4, for mobile stand mounted ProBP 3400,
United Kingdom
PWCD-5WW-6
Power cord assembly 6, for handheld, or desk or wall mounted
ProBP 3400, Australia/New Zealand —Orange
Directions for use
Appendix
Part Number
Description
PWCD-5WT-6
Power cord assembly 6, for mobile stand mounted ProBP 3400,
Australia/New Zealand —Orange
PWCD-5WW-C
Power cord assembly C, for handheld, or desk or wall mounted
ProBP 3400, China
PWCD-5WT-C
Power cord assembly C, for mobile stand mounted ProBP 3400,
China
PWCD-5WW-7
Power cord assembly 7, for handheld, or desk or wall mounted
ProBP 3400, South Africa
PWCD-5WT-7
Power cord assembly 7, for mobile stand mounted ProBP 3400,
South Africa
PWCD-5WT-J
Power cord assembly N, for mobile stand mounted ProBP 3400,
Japan
3400-100
Battery door
Part Number
Description
S1-3400
Comprehensive Partner Program, ProBP 3400, 1 year
S2-3400
Biomed Partner Program, ProBP 3400, 1 year
S3-3400
Investment Pro Partner Program, ProBP 3400, 1 year
S4-3400
Preventive Partner Program, ProBP 3400, 1 year
103521
Welch Allyn Service Tool CD
Service
Licensed features
Part Number
Description
3400-SUREBP
SureBP activation code
3400-BT
Bluetooth activation code
Literature/Documentation
Part Number
Description
Directions for Use
103701
Kit, CD, Directions for Use, ProBP 3400
71
72
Appendix
Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
Part Number
Description
Startup Guide
407673
Startup Guide ProBP 3400
Directions for Use, Mounting Options
104388
Directions for use, Mounting kit instructions for ProBP 3400
mobile stand
104387
Directions for use, Mounting kit instructions for ProBP 3400 wall
mount
104386
Directions for use, Mounting kit instructions for ProBP 3400 desk
mount
Configuration options
Model
Description
34BFHT-B*
Includes Welch Allyn SureBP® technology, Bluetooth® wireless technology, rechargeable
lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, handheld configuration
34BFWT-B*
Includes Welch Allyn SureBP® technology, Bluetooth® wireless technology, rechargeable
lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, wall mounted configuration
34BFST-B*
Includes Welch Allyn SureBP® technology, Bluetooth® wireless technology, rechargeable
lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, mobile stand mounted configuration
34XFHT-B*
Includes Welch Allyn SureBP® technology, rechargeable lithium-ion battery, size 11 and
size 12 FlexiPort® cuffs, handheld configuration
34XFWT-B*
Includes Welch Allyn SureBP® technology, rechargeable lithium-ion battery, size 11 and
size 12 FlexiPort® cuffs, wall mounted configuration
34XFST-B*
Includes Welch Allyn SureBP® technology, rechargeable lithium-ion battery, size 11 and
size 12 FlexiPort® cuffs, mobile stand mounted configuration
34BXHT-B*
Includes Bluetooth® wireless technology, rechargeable lithium-ion battery, size 11 and size
12 FlexiPort® cuffs, handheld configuration
34BXWT-B*
Includes Bluetooth® wireless technology, rechargeable lithium-ion battery, size 11 and size
12 FlexiPort® cuffs, wall mounted configuration
34BXST-B*
Includes Bluetooth® wireless technology, rechargeable lithium-ion battery, size 11 and size
12 FlexiPort® cuffs, mobile stand mounted configuration
34XXHT-B*
Includes rechargeable lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, handheld
configuration
34XXWT-B*
Includes rechargeable lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, wall
mounted configuration
34XXST-B*
Includes rechargeable lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, mobile stand
mounted configuration
Directions for use
Appendix
*Replace final digit in model number with regional code listed in the table below.
Accessories and replacement parts
Code
Region
6
Australia/New Zealand - Orange
C
China
2
Europe
J
Japan (mobile stand version only)
B
North America
7
South Africa
4
United Kingdom
73