Welch Allyn® Home Blood Pressure Monitor

Welch Allyn Home
Blood Pressure Monitor
Directions for use
901042 Automated Blood Pressure System
Software version 1.X
ii
Welch Allyn Home Blood Pressure Monitor
© 2017 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 by Welch 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.
SureBP® Technology is a registered trademark 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 © 2017 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 Welch
Allyn Technical Support: http://www.welchallyn.com/
:
727404
DIR 80022409 Ver. B
Revised: 2017-11
901042 Automated Blood
Pressure System
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallynhome.com
Made in Mexico
Directions for use iii
Contents
Contents . . . . . . . . .
Introduction . . . . . .
Indications for use .
Contraindications .
Symbols. . . . . . . . . .
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iii
.1
.2
.3
.4
Documentation symbols . . . . . . . . . . . . . . . .4
Power symbols . . . . . . . . . . . . . . . . . . . . . . . .4
Shipping, storing, and environment symbols . 5
Blood pressure device and cuff symbols . . . . . 6
Miscellaneous symbols . . . . . . . . . . . . . . . . . . . . . 7
About warnings and cautions . . . . . . . . .9
Warnings and cautions . . . . . . . . . . . . . . . . 10
Contents list. . . . . . . . . . . . . . . . . . . . . . . . . . 15
Controls and indicators . . . . . . . . . . . . . . . . . . . . 16
Power options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Screen elements . . . . . . . . . . . . . . . . . . . 19
Measuring blood pressure . . . . . . . . . . .22
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Set up your equipment . . . . . . . . . . . . . . . .23
Connect the blood pressure air tube . . . .24
Pair a smartphone, a tablet, or a communication
hub with the monitor . . . . . . . . . . . . . . . . . . . . . 26
Position the blood pressure cuff . . . . . . . . 27
Start the measurement . . . . . . . . . . . . . . . .29
Some points to remember about your blood
pressure device:. . . . . . . . . . . . . . . . . . . . . . . . . . 32
Disconnect the blood pressure air tube . . . . . 33
iv
Welch Allyn Home Blood Pressure Monitor
Blood pressure facts, pointers, and best
practices . . . . . . . . . . . . . . . . . . . . . . . . . 34
Helpful definitions. . . . . . . . . . . . . . . . . . . . .34
Irregular heartbeat detector. . . . . . . . . . . .34
Maintenance . . . . . . . . . . . . . . . . . . . . . . 38
Maintain the monitor and cuff . . . . . . . . . .38
Troubleshooting . . . . . . . . . . . . . . . . . . 39
Problems and error messages . . . . . . . . . .39
Technical alarms . . . . . . . . . . . . . . . . . . . . . .39
Physiological alarms . . . . . . . . . . . . . . . . . . . . . . 42
Specifications . . . . . . . . . . . . . . . . . . . . . 43
General radio compliance . . . . . . . . . . . . . .45
Federal Communication Commission (FCC)
Interference Statement . . . . . . . . . . . . . . . 46
FCC Radiation Exposure Statement . . . . .47
Industry Canada (IC) compliance . . . . . . .47
Complied standards list . . . . . . . . . . . . . . . . . . . 50
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . .53
Approved accessories . . . . . . . . . . . . . .55
Emissions and immunity information .57
Directions for use 1
Introduction
The Welch Allyn Home blood pressure
monitor is indicated for adult use in the
home or domestic setting only.
The Welch Allyn Home blood pressure
monitor features blood pressure
measurement via SureBP® Technology,
pulse rate measurement, and data
management using Bluetooth® Smart
technology.
SureBP Technology is an
advanced blood pressure
measurement technology
that obtains a blood pressure
reading during the inflation cycle (as the
cuff pumps up). This technology allows
for a faster, more comfortable reading. If
on inflation, SureBP Technology is unable
to determine a blood pressure due to
excessive patient movement or any
arrhythmia, it will inflate the cuff to a
slightly higher pressure, then measure
the blood pressure while deflating the
cuff, providing an accurate reading with
less chance of a reading failure.
The design provides you with two years
of reliable service. Readings taken by the
monitor are equivalent to those obtained
2
Welch Allyn Home Blood Pressure Monitor
by a trained observer using the cuff and
stethoscope auscultation method.
This Directions for use contains
important safety and care information
and provides step by step instructions
for using the monitor. Read the manual
thoroughly before using the monitor.
Indications for use
The Welch Allyn Home blood pressure
monitor is a digital monitor intended for
use in measuring blood pressure and
heart rate in adult patient populations
with arm circumferences between 15 cm
to 54 cm (approximately 6 to 21 inches).
The device detects the appearance of
irregular heartbeats during
measurement and gives a warning signal
with readings.
Directions for use 3
Contraindications
This device is contraindicated for any
person who is connected to a wearable
or implantable electronic device or
instrument, such as a pacemaker or
defibrillator.
This blood pressure monitor is not
intended to be a diagnostic device.
Contact your physician if hypertensive
values are indicated.
4
Welch Allyn Home Blood Pressure Monitor
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.
Follow instructions/directions for use
(DFU) -- mandatory action
Power symbols
Direct current
Power
Directions for use 5
Shipping, storing, and environment
symbols
Relative humidity limits
Recycle the product separate from
other disposables
Temperature limits
Atmospheric air pressure
Recycle
Stacking limit by number
6
Welch Allyn Home Blood Pressure Monitor
Blood pressure device and cuff
symbols
SureBP technology logo
Artery marker
Range
Index edge
Limb circumference
(Minimum/Maximum)
Lot code
Not made with natural
rubber latex
Directions for use 7
Miscellaneous symbols
Type BF applied part
Serial number
Product Identifier
Manufacturer
Reorder number, Model number
Non-ionizing electromagnetic
radiation
Global Trade Identification
Number
Class II equipment
8
Welch Allyn Home Blood Pressure Monitor
IP22
Ingress protection: the device is
protected against solid foreign
objects of 12.5mm and greater
and against vertically falling
water drops when ENCLOSURE
is tilted up to 15°
Bluetooth
Directions for use 9
About warnings and cautions
Caution statements can appear on the
Welch Allyn Home blood pressure
device, the packaging, the shipping
container, or in this Directions for use.
The Welch Allyn Home blood pressure
device is safe for adults when used in
accordance with the instructions and
caution statements presented in this
Directions for use.
Before using the device, you must
familiarize yourself with all cautions, with
the steps to power up the device, and
with the sections of this Directions for
use that pertain to your use of the
device. In addition to reviewing the
general cautions presented in the next
section, you must also review the more
specific cautions that appear throughout
the manual in conjunction with setup/
startup, operation, and maintenance
tasks.
•
•
Failure to understand and observe
any warning statement in this
manual could lead to injury or illness.
Failure to understand and observe
any caution statement in this manual
could lead to damage to the
10
Welch Allyn Home Blood Pressure Monitor
equipment or other property, or loss
of measurement data.
Warnings and cautions
WARNING Injury risk. The device is
not suitable for measuring the blood
pressure of neonatal infants or
children.
WARNING Injury risk. The device is
not suitable for use on pregnant
women, users with implanted
electrical devices, users with
preeclampsia, premature ventricular
beats, atrial fibrillation, peripheral
arterial disease, and users undergoing
intravascular therapy or arteriovenous shunt or people who received
a mastectomy. Consult your doctor
prior to using the unit if you suffer
from any of these illnesses or
conditions.
WARNING Injury risk. Do not take
any therapeutic measures on the basis
of a self measurement. Never alter the
dose of a medicine prescribed by a
doctor. Consult your doctor if you
have any question about your blood
pressure.
WARNING Injury risk. Keep the unit
out of reach of infants, children, or
pets, since inhalation or swallowing of
small parts is dangerous or even fatal.
Directions for use 11
WARNING Injury risk. The device is
not intended to be a selfmeasurement station used in a public
place or center. Use the device only in
your home or temporary residence.
WARNING Injury risk. Do not burn
batteries. Batteries may leak or
explode.
WARNING Injury risk. If you
experience discomfort during a
measurement, such as pain in the arm
or other complaints, press the power
button immediately to release the air
from the cuff. Loosen and remove the
cuff from your arm.
WARNING Injury risk. On the rare
occasion of a fault causing the cuff to
remain fully inflated during
measurement, open the cuff
immediately. Prolonged high pressure
applied to the arm (cuff pressure
>300mmHg or constant pressure
>15mmHg for more than 3 minutes)
might lead to bruising and discolored
skin.
WARNING Injury risk. This unit is not
suitable for continuous monitoring
during medical emergencies or
operations.
WARNING Injury risk. Taking blood
pressure measurements too
frequently could disrupt blood
circulation and cause injuries.
12
Welch Allyn Home Blood Pressure Monitor
WARNING Injury risk. Do not
kink the connection tube during
use. The cuff pressure might
continuously increase, which
could prevent blood flow and
result in injury.
WARNING Injury risk. Never
apply the cuff over damaged skin.
This can cause further injury.
WARNING Injury risk. If applying
to someone else, do not touch
output of the batteries/adapter
and the user simultaneously.
WARNING Injury risk. Do not use
the unit if you are allergic to
polyester or synthetic materials.
WARNING Injury risk. Excessive
tube lengths could cause
strangulation if you don't manage
them properly.
WARNING Injury risk. Do not
connect the air tube to other
medical equipment. This could
cause air to be pumped into
intravascular systems or high
pressure, which could lead to
serious injuries.
WARNING Injury risk. Dispose of
accessories, detachable parts, and
the device according to the local
guidelines.
Directions for use 13
WARNING Injury risk. Do not
service or perform any
maintenance while using the
device.
WARNING Injury risk. Use only
accessories approved by the
manufacturer. Using unapproved
accessories might cause damage
to the unit and injure users.
WARNING Injury risk. No
modification to this equipment is
allowed. Modifying the equipment
could damage the unit or
endanger the user.
14
Welch Allyn Home Blood Pressure Monitor
Caution This device is intended for
non-invasive measuring and
monitoring of arterial blood
pressure. It is not intended for use
on extremities other than arm or for
functions other than obtaining a
blood pressure measurement.
Caution Do not wrap the cuff on
the same arm to which another
monitoring device is applied. One or
both devices could temporarily stop
functioning if you try to use them
on the same arm at the same time.
Caution To avoid measurement
errors, avoid taking blood pressure
measurements near a strong
electromagnetic field radiated
interference signal or electrical fast
transient/burst signal.
Caution The materials of the cuff
have been tested and found to
comply with requirements of ISO
10993-5:2009 and ISO 1099310:2010. It will not cause any
potential sensitization or irritation
reaction.
Caution Before use, make sure the
device functions safely and is in
proper working condition.
Caution Use the device in the
environment described in this
directions for use. Otherwise, you
will compromise the device’s
performance and reduce its lifetime.
Directions for use 15
Caution Do not attempt to repair
the unit yourself if it malfunctions.
Only have repairs carried out by
authorized service centers.
Caution Report any unexpected
operation or events to the
manufacturer.
Caution Use a soft cloth to clean
the entire unit. Do not use any
abrasive or volatile cleaners. See
the cleaning instructions
presented later in this Directions
for use.
Contents list
The following items are in the device
box:
•
•
•
•
•
Blood Pressure Monitor
D-Ring Standard Wide Cuff (22cm
to 42cm) with air tube attached
(4) AA alkaline batteries
Directions for use
Quick reference guide
16
Welch Allyn Home Blood Pressure Monitor
Controls and indicators
Monitor front
No.
Feature
Description
1
Blood
pressure
cuff
Apply to upper arm to
take a blood pressure
measurement
2
Air tube
Connects the cuff to the
air connector plug
3
Air
Air tube connects to the
connector air connector plug
plug
4
Power
button
Powers on the monitor,
starts and stops a blood
pressure measurement,
and — when pressed for 2
seconds — initiates a
Bluetooth pairing
Directions for use 17
No.
Feature
Description
5
LCD
Display
Displays blood pressure
reading and other
pertinent information
regarding the reading
Monitor back
No. Feature
Description
1
Direct current
power
connection
When used with an
accessory power cord
(not included),
connects the monitor
to a power outlet
2
Battery
Houses 4 AA alkaline
compartment batteries
(behind cover)
18
Welch Allyn Home Blood Pressure Monitor
Power options
Caution To get optimal
performance and protect your
monitor, use only the correct
batteries or the Welch Allynapproved power adapter.
The monitor is powered by one of two
sources:
•
•
4 AA alkaline batteries
AC adapter (6v
1A) (not
included)
Directions for use 19
Screen elements
The liquid crystal display (LCD) displays
the following: systolic blood pressure
(mmHg), diastolic blood pressure
(mmHg), pulse rate (bpm), heart beat
(regular or irregular) while acquiring
blood pressure measurements, excessive
motion alert, Bluetooth connectivity
status or data transmission error, alarm
priority, and battery charge level.
20
Welch Allyn Home Blood Pressure Monitor
Symbol
Description
Systolic blood pressure
mmHg = measurement unit
of the blood pressure
Diastolic blood pressure
mmHg = measurement unit
of the blood pressure
Pulse in beats per minute
Irregular heartbeat
Monitor is detecting an
irregular heartbeat during
measurement
Heart beat
Monitor is detecting a
heartbeat during
measurement
Battery indicator
Indicates the current battery
charge
Battery indicator
Indicates the current battery
charge
Directions for use 21
Symbol
Description
Bluetooth connectivity status
or data transmission error
Motion indicator
Motion may result in an
inaccurate measurement.
Reading out of range
Either SYS > 260mmHg or
DIA > 220mmHg. The symbol
may appear in either the SYS
or DIA area of the screen.
Alarm priority = Low (an!
appears near the top of the
screen)
Reading out of range
Either SYS < 50mmHg or DIA
<25mmHg. The symbol may
appear in either the SYS or
DIA area of the screen.
Alarm priority = Low (an!
appears near the top of the
screen)
22
Welch Allyn Home Blood Pressure Monitor
Measuring blood pressure
Overview
You are the intended operator of the
device. You can measure your blood
pressure and then save and send
measurement data to a smartphone or
tablet. You can also maintain your device
and its accessories, and you can change
the batteries under normal
circumstances.
To measure your blood pressure, you
need the following:
•
•
•
Blood pressure monitor with
batteries inserted
Blood pressure cuff ("D-ring" style
for easy, one-handed adjustment)
Blood pressure air tube
To save and transfer blood pressure
measurements, you also need a
smartphone or tablet with Bluetooth
wireless connectivity and the application
or software to receive your data, such as
the Welch Allyn Home application or
another healthcare provider application.
Directions for use 23
Set up your equipment
Insert or replace the batteries
WARNING Injury risk. Do not
burn batteries. Batteries may leak
or explode.
Caution Remove the batteries if
the device is not used regularly.
Caution Dispose of old batteries
by following your local recycling
guidelines.
If you are not using AC power, you must
install 4 AA alkaline batteries before
using the device.
Replace the batteries when any of the
following occurs:
•
•
•
The battery charge indicator
indicates a low charge
The display dims
The display does not light up
1.
Slide off the battery cover.
24
Welch Allyn Home Blood Pressure Monitor
2.
Install the batteries by matching the
polarity as shown in the diagram.
3.
Replace the cover.
Connect the blood pressure air tube
1.
Locate the air connector plug on the
left side of the blood pressure
monitor.
Directions for use 25
2.
Place your thumb and forefinger on
the metal air tube connector and
slide it onto the air connector plug.
3.
Confirm that the air tube connector
locks into place. Listen for a click.
When the air tube connector is
properly seated, you cannot pull it
off the air connector plug.
NoteYou may leave the air tube
connected to the blood pressure
monitor if you take your blood
pressure regularly and have a
convenient place to store the
blood pressure monitor and cuff
together without kinking the tube.
26
Welch Allyn Home Blood Pressure Monitor
Pair a smartphone, a tablet, or a
communication hub with the monitor
Advanced Bluetooth 4.0 technology
enables your smartphone, your tablet, or
a communication hub to receive your
personal health information from your
blood pressure monitor. You have two
alternatives to pair the monitor with
these devices:
•
•
If you are using the Welch Allyn
Home application, follow the pairing
instructions presented in the
application.
Contact your Remote Monitoring
Solution provider or use the
instructions that office provided to
set up these communications
devices.
With either alternative, you complete the
same steps on the monitor:
1.
Confirm that smartphone, tablet, or
communication hub is powered on
and in discoverable mode (ready for
pairing). Bluetooth wireless
connectivity is only available for
devices which support Bluetooth 4.0
technology.
2.
Press and hold the Power button on
the blood pressure monitor for 2
Directions for use 27
seconds to power on the device and
activate Bluetooth pairing. The
Bluetooth symbol flashes while
discovering the monitor.
If successful, a steady
symbol
surrounded by a dotted line appears on
the LCD screen. If unsuccessful, the
appears.
Position the blood pressure cuff
To achieve an accurate blood pressure
reading, follow these steps to position
the blood pressure cuff properly.
1.
Remove any sleeves covering your
upper arm.
NoteThe preferred site for taking a
blood pressure measurement is
your bare upper arm.
28
Welch Allyn Home Blood Pressure Monitor
2.
Place the cuff loosely over your arm
so that the blood pressure tube
extends down over your hand. It
should appear on your arm as shown.
3.
Open the cuff to resize it as needed
and slide it over your bare upper arm.
The bottom edge of the cuff should
be 2 to 3 centimeters (0.8 to 1.2
inches) above the bend in your arm,
and the tube and artery marker
should appear on your arm as shown.
Directions for use 29
4.
Keeping the artery marker and the
tube in place, wrap the cuff snugly
around your arm, but not too tight. If
you can insert just two fingers
between the cuff and your arm, the
tightness is acceptable.
Start the measurement
1.
Prepare yourself to take your blood
pressure.
a.
Sit comfortably in a chair that
supports your back.
b.
Keep legs uncrossed.
c.
Place feet flat on the floor.
d.
Support your arm on the flat
surface.
30
Welch Allyn Home Blood Pressure Monitor
e.
Ensure the cuff is level with your
heart (right atrium).
f.
Rest for 5 minutes after sitting
down and positioning the blood
pressure cuff.
2.
Verify that the cuff is positioned
correctly with the tube running
down the middle of your forearm.
3.
Press the Power button to power up
the monitor and begin the blood
pressure measurement.
The cuff inflates and tightens around
your arm until it completes the
measurement. A vertical stack of
segments appears onscreen to show
increasing pressure in the cuff. The
heart icon in the upper-left corner
blinks to indicate your pulse rate
until the measurement is complete.
NoteIf you press the Power button to
stop the measurement, dotted
lines replace the SYS and DIA
numbers onscreen.
When the inflation cycle is complete,
systolic and diastolic measurements
as well as your pulse rate appear
onscreen.
Directions for use 31
4.
Record your measurement results.
Either record these measurements
manually along with the time of
measurement, or transfer them
electronically to your connected
device.
Caution The device that
receives transferred
measurements displays the most
recent record first as record 1.
Each new measurement
becomes record 1, and all other
records move down the list (for
example, 2 becomes 3, and so
on). You can store a maximum of
99 records. When you pass that
limit, the oldest record drops
from the list.
NoteFor a meaningful comparison, try
to take measurements under
consistent conditions. For
example, take daily measurements
at approximately the same time,
on the same upper arm, or as
directed by your physician.
32
Welch Allyn Home Blood Pressure Monitor
Some points to remember about your
blood pressure device:
•
After 10 seconds of inactivity, the
device powers down.
•
If you press and release the Power
button, the device powers down.
•
After successful transfer, the device
powers off the Bluetooth radio, and
the Bluetooth icon (and rectangle)
disappear.
Directions for use 33
Disconnect the blood pressure air tube
NoteYou may leave the air tube
connected to the blood pressure
monitor if you take your blood
pressure regularly. Store the
monitor and cuff in a convenient
place; do not kink the tube.
1.
If you choose to disconnect the air
tube after completing a blood
pressure measurement, place your
thumb and forefinger on the
grooved portion of the metal air
tube connector and pull it back. Do
not twist the connector.
2.
Gently pull the air tube away from
the monitor. You can now store the
monitor and the cuff.
34
Welch Allyn Home Blood Pressure Monitor
Blood pressure facts, pointers, and
best practices
Helpful definitions
Systolic pressure When ventricles
contract and pump blood out of your
heart, the point at which blood pressure
reaches its maximum value in the cycle.
Diastolic pressure When the ventricles
relax, the point at which blood pressure
reaches its minimum value in the cycle.
Pulse rate A measurement of the heart
rate, or the number of times the heart
beats per minute. As the heart pushes
blood through the arteries, the arteries
expand and contract with the flow of the
blood.
Irregular heartbeat detector
An irregular heartbeat (IHB) is detected
when a heartbeat rhythm varies while
the unit is measuring the systolic and
diastolic blood pressure. During each
measurement, the monitor records the
heartbeat intervals and calculates the
average. If any average is larger than or
equal to 25%, the irregular heartbeat
symbol appears on the display when the
measurement results appear.
Directions for use 35
Caution The appearance of the
IHB icon indicates that a pulse
irregularity consistent with an
irregular heartbeat was detected
during measurement. Usually this
is NOT a cause for concern.
However, if the symbol appears
often, we recommend you seek
medical advice. The device does
not replace a cardiac examination
but detects pulse irregularities at
an early stage.
Why does my blood pressure fluctuate
throughout the day?
•
•
•
•
•
Individual blood pressure varies
multiple times every day because of
weather, emotion, and activity.
The way you position your cuff and
your measurement posture can
affect blood pressure. Try to take
blood pressure measurements under
similar conditions.
Sometimes blood pressure on one
arm is different from blood pressure
on your other arm. Use the same
arm for blood pressure
measurements.
Medication might affect your blood
pressure.
The "white coat effect" might cause
your blood pressure to be higher in a
hospital or doctor's office.
36
Welch Allyn Home Blood Pressure Monitor
Factors that could cause inaccurate
measurements
•
•
•
•
•
•
•
•
•
•
Cuff position is poor
Cuff is too loose or too tight
Cuff is applied over clothing rather
than on a bare upper arm
Taking a measurement within 1 hour
of eating or drinking
Taking a measurement within 20
minutes of taking a bath
Being in a cold environment
Taking a measurement immediately
after smoking or drinking
caffeinated beverages
Taking a measurement while talking
or moving your fingers
Taking a measurement when you
need to urinate
Taking measurements in rapid
succession
Factors that promote accurate blood
pressure measurements
•
•
•
•
•
Proper cuff position on the upper
arm
Proper cuff tightness
No clothing under the cuff or
restricting circulation above the cuff
Proper posture: feet flat on the floor,
back straight, legs uncrossed, arm
resting on a flat surface, upper arm
at heart level
Relaxing or sitting still for a few
minutes after positioning the cuff
Directions for use 37
•
•
•
and before taking a blood pressure
measurement
Sitting still during measurement
Not talking during measurement
Waiting at least 3 minutes between
measurements
38
Welch Allyn Home Blood Pressure Monitor
Maintenance
Maintain the monitor and cuff
The monitor does not require calibration.
To get the best performance from your
monitor, follow the maintenance steps
below.
•
•
•
Store the unit in a dry place away
from direct sunlight.
Avoid shaking and dropping the
monitor.
Avoid operating the monitor in dusty
and unstable temperature
environments.
Cleaning
Caution Use a soft cloth to clean
the entire unit. Do not use any
abrasive or volatile cleaners.
1.
Clean the monitor only when
necessary with one of the following
compatible cleaning agents:
•
•
2.
70% isopropyl alcohol
10% chlorine bleach/90% water
solution (standard bleach wipe)
If necessary, you may wipe the cuff
with a soft, damp cloth.
Directions for use 39
Troubleshooting
This section includes a list of error
messages and frequently asked
questions for problems you may
encounter with your blood pressure
monitor. If the device is not operating as
you think it should, check here before
arranging for service.
Problems and error messages
The device presents technical alarms
and low-priority physiological alarms.
Technical alarms occur when there is a
device-related error. Physiological alarms
occur when blood pressure
measurements fall outside of set alarm
limits.
Technical alarms
Problem
Symptom Root
cause
Solution
No power
Display will
not light up
Batteries are
drained.
Replace
with new
batteries
Batteries are
inserted
incorrectly.
Insert the
batteries
correctly
AC adapter
is inserted
incorrectly
Insert the
AC
adapter
tightly
40
Welch Allyn Home Blood Pressure Monitor
Problem
Symptom Root
cause
Solution
Low
batteries
The display
indicates
the “BATLO”
message,
pauses for
3 seconds.
The battery
icon shows
empty
(does not
flash.)
Batteries are
low.
Replace
with new
batteries
Error
messages
E 01 shows
The cuff is
not secure
Readjust
the cuff,
relax for a
moment,
and then
measure
again
E 03 shows
There is too
much
pressure in
the cuff
Refasten
the cuff
and then
measure
again
E 10 or E 11
shows
The monitor
detected
motion while
measuring
Readjust
the cuff,
relax for a
moment,
and then
measure
again
Directions for use 41
Problem
Symptom Root
cause
Solution
Low
batteries
The display
indicates
the “BATLO”
message,
pauses for
3 seconds.
The battery
icon shows
empty
(does not
flash.)
Batteries are
low.
Replace
with new
batteries
Error
messages
E 01 shows
The cuff is
not secure
Readjust
the cuff,
relax for a
moment,
and then
measure
again
E 03 shows
There is too
much
pressure in
the cuff
Refasten
the cuff
and then
measure
again
E 10 or E 11
shows
The monitor
detected
motion while
measuring
Readjust
the cuff,
relax for a
moment,
and then
measure
again
42
Welch Allyn Home Blood Pressure Monitor
Problem
Symptom Root
cause
Solution
EE or E 19
shows
Measure
again. If
the
problem
persists,
contact
the
retailer
or
Welch
Allyn
customer service
at
www.
welch
allyn
home.
com for
further
assistance.
Hardware
error
Visit www.welchallynhome.com for
further assistance.
Directions for use 43
Physiological alarms
Symptom Root cause
Out of range.
Either SYS
>260mmHg or
DIA
>220mmHg.
The symbol
may appear in
either the SYS
or DIA area of
the screen.
Solution
Press and
hold the
Power
button to
reestablish
Bluetooth
connectivity.
Measure
again. If the
problem
persists,
contact your
physician.
Alarm
priority =
Low
Out of range.
Either SYS
<50mmHg or
DIA <25mmHg.
The symbol
may appear in
either the SYS
or DIA area of
the screen.
Press and
hold the
Power
button to
reestablish
Bluetooth
connectivity.
Measure
again. If the
problem
persists,
contact your
physician.
Alarm
priority =
Low
44
Welch Allyn Home Blood Pressure Monitor
Specifications
Item
Specification
Power supply:
Battery powered
mode:
6VDC 4*AA batteries
Power supply: AC
adapter powered
mode:
Input: 100-240V, 5060Hz, 400mA;
Output: 6V, 1A
Power supply model
number
UE08WCP-06100SPA
Display mode
Digital LCD
V.A.68mm*90mm
Measurement model Oscillometric testing
mode
Measurement range
Rated cuff pressure:
0mmHg to
300mmHg (0kPa40kPa)
Measurement
pressure:
SYS: 50 to 260mmHg
DIA: 25 to 220mmHg
Pulse value: (40 to
199)beat/minute
Accuracy
Pressure:
±0.4kPa (3mmHg)
Pulse value:±4%
Directions for use 45
Item
Specification
Normal working
conditions
Temperature: 5°C to
40°C
Relative humidity 85%
RH
Atmospheric
pressure: 86kPa to
106kPa
Storage and
transportation
condition
Temperature:-20°C to
60°C
Relative Humidity:
10% RH–93% RH
Atmospheric
Pressure: 50kPa to
106 kPa
Circumference of the Part
upper arm
Number
Cuff size
Extra
15cm to
small =
24cm
RPMBPACC-01
Net Weight
Standard
wide =
RPMBPACC02
22cm to
42cm
Extra
large =
RPMBPACC03
40cm to
54cm
Approx. 283g
(Excluding the dry
cells)
46
Welch Allyn Home Blood Pressure Monitor
Item
Specification
External dimensions
Approx. 94mm
*142mm*66mm
Degree of protection Type BF applied part
Protection against
ingress of water
IP22
Software Version
Version 1.X
General radio compliance
Item
Specification
Bluetooth Module No. AW51822
Radio Frequency
(RF) Range
2402 MHz to 2480 MHz
Output Power
4.0 dBm
Supply Voltage
1.8V to 3.6V
Antenna Gain
0.0 dBi
Transmitting Distance 10 meters (30 feet)
Directions for use 47
Federal Communication Commission
(FCC) Interference Statement
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 (FCC ID: OU9TMB1591A) has been tested and found to comply
with the limits for a Class B digital
device, pursuant to Part 15 of the 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 and, if not installed and used in
accordance with the instructions, 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
48
Welch Allyn Home Blood Pressure Monitor
turning the equipment off and on, the
user is encouraged to try to correct the
interference by one of the following
measures.
1.
Reorient or relocate the receiving
antenna.
2.
Increase the separation between the
equipment and receiver.
3.
Consult the dealer or an experienced
radio/TV technician for help.
Any changes or modifications not
expressly approved by the party
responsible for compliance could
void the user's authority to operate
this equipment.
FCC Radiation Exposure Statement
This equipment complies with FCC
radiation exposure limits set forth for an
uncontrolled environment. This
transmitter must not be co-located or
operating in conjunction with any other
antenna or transmitter.
Industry Canada (IC) compliance
To ensure compliance with FCC and
Industry Canada RF exposure
requirements, this device must be
Directions for use 49
installed in a location where the
antennas of the device will have a
minimum distance of at least 20 cm from
all persons. Using higher gain antennas
and types of antennas not certified for
use with this product is not allowed. The
device shall not be co-located with
another transmitter.
Pour s'assurer de la conformité des
exigences aux expositions RF de la FCC
et de l'Industry Canada, cet appareil doit
être installé dans un emplacement où les
antennes de l'appareil sont au moins à
20 cm de distance de toute personne.
L'utilisation d'antennes et de types
d'antennes à gain supérieur non garantis
avec ce produit est interdite. L'appareil
ne doit pas être installé à proximité d'un
autre émetteur.
This device complies with Industry
Canada licence-exempt RSS standard(s).
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 the device.
Cet appareil est conforme aux normes
RSS exemptes de licence de l'Industry
50
Welch Allyn Home Blood Pressure Monitor
Canada. Son fonctionnement est soumis
aux deux conditions suivantes: (1)
l'appareil ne doit pas produire de
brouillage, et (2) l'appareil doit accepter
tout brouillage radioélectrique subi,
même si le brouillage est susceptible
d'en compromettre le fonctionnement.
This radio transmitter (IC: 12725ATMB1591A) has been approved by
Industry Canada to operate with the
antenna listed in the specification table.
Ce transmetteur de radio (IC: 12725ATMB1591A) a été approuvé par l'Industry
Canada pour fonctionner avec l'antenne
répertoriée dans la table des
spécifications.
This Class B digital apparatus complies
with Canadian ICES-003.
Cet appareil numérique de la classe B est
conforme à la norme NMB-003 du
Canada.
Directions for use 51
Complied standards list
Item
Standard
Risk
management
ISO/EN 14971 Medical
devices — Application of
risk management to
medical devices
Labeling
ISO/EN 15223-1 Medical
devices. Symbols to be
used with medical device
labels, labeling and
information to be
supplied. General
requirements
User manual
EN 1041 Medical
equipment manufacturers
to provide information
General
Requirements
for Safety
IEC 60601-1+A1 Medical
electrical equipment Part 1: General
requirements for basic
safety and essential
performance
IEC 60601-1-11 Medical
electrical equipment Part 1-11: General
requirements for basic
safety and essential
performance - Collateral
standard: Requirements
for medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment
52
Welch Allyn Home Blood Pressure Monitor
Item
Standard
Electromagnetic
compatibility
IEC/EN 60601-1-2 Medical
electrical equipment Part 1-2: General
requirements for basic
safety and essential
performance - Collateral
standard: Electromagnetic
compatibility Requirements and tests
Performance
requirements
and clinical
investigation
IEC 80601-2-30 Medical
electrical equipment- Part
2-30: Particular
requirements for the basic
safety and essential
performance of
automated non-invasive
sphygmomanometers
ISO81060-2:2013 Noninvasive
sphygmomanometers —
Part 2: Clinical validation
of automated
measurement type
Software lifecycle processes
IEC/EN 62304+AC:
Medical device software Software life cycle
processes
Directions for use 53
Item
Standard
Usability
IEC 62366 Medical
devices - Application of
usability engineering to
medical devices (IEC
62366)
IEC 60601-1-6 Medical
electrical equipment Part 1 -6: General
requirements for basic
safety and essential
performance - collateral
standard: Usability
54
Welch Allyn Home Blood Pressure Monitor
Warranty
Welch Allyn will warranty the blood
pressure monitor to be free of defects in
material and workmanship and to
perform in accordance with
manufacturer specifications for the
period of two years 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.
Directions for use 55
The product warranty is also subject to
the following terms and limitations.
•
•
•
Accessories are not covered by the
warranty.
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 at
www.welchallynhome.com/support.
56
Welch Allyn Home Blood Pressure Monitor
Approved accessories
Item
Description
RPM-BPACC-01
D-Ring Extra Small Cuff
(15–24cm)
RPM-BPACC-02
D-Ring Standard Wide
Cuff (22-42cm)
RPM-BPACC-03
D-Ring Extra Large Cuff
(40–54cm)
RPM-BPACC-04 RPM BP AC Adapter.
This adapter is an
alternate power source
for the blood pressure
monitoring device.
Group 1
RF emissions
CISPR 11
Compliance
The Welch Allyn Home Blood Pressure Monitor 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.
Electromagnetic environment - guidance
As indicated in Table 6 of IEC 60601-1-2:2007 for ME Equipment, a typical cell
phone with a maximum output power of 2 W yields d=3,3m at an IMMUNITY LEVEL
of 3V/m).
Emissions
test
Note
Caution Wireless communications equipment, such as wireless home network
devices, mobile phones, cordless telephones and their base stations, walkie-talkies
can affect this equipment and should be kept at least a distance d=3,3m away
from the equipment.
The Welch Allyn Home Blood Pressure Monitor H-BP100SBP is intended for use in the
electromagnetic environment specified below. The customer or user of the Welch Allyn
Home Blood Pressure Monitor should assure that it is used in such an environment.
Electromagnetic emissions
Emissions and immunity information
Directions for use 57
IEC 61000-3-3
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-2
Harmonic
emissions
CISPR 11
RF emissions
Complies
Class A
Class B
The Welch Allyn Home Blood Pressure Monitor is
suitable for use in all establishments, including domestic
establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Electromagnetic emissions
58
Welch Allyn Home Blood Pressure Monitor
Electromagnetic immunity
IEC 61000-4-5
Surge
IEC 61000-4-4
Electrical fast
transient/burst
± 2kV line(s) to
earth
± 1 kV line(s) to
line(s)
±1 kV for input/
output lines
±2 kV for
power supply
lines
± 1 kV
differential
mode
±2 kV for
power supply
lines
± 15kV air
± 15kV air
IEC 61000-4-2
±8 kV contact
±8 kV contact
Electrostatic
discharge
(ESD)
Compliance
level
IEC 60601
test level
Immunity
test
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.
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electromagnetic environment guidance
The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch Allyn Home Blood
Pressure Monitor should assure that it is used in such an environment.
Directions for use 59
40% UT
< 5% UT
(>95% dip in
UT) for 5
seconds
3A/m and
30 A/m
< 5% UT
(>95% dip in
UT) for 5
seconds
(30% dip in UT)
for 25 cycles
3A/m and
30 A/m
70% UT
(30% dip in UT)
for 25 cycles
70% UT
(60% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 5 cycles
< 5% UT
(>95% dip in
UT) for 0.5
cycle
(>95% dip in
UT) for 0.5
cycle
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Welch
Allyn Home Blood Pressure Monitor
requires continued operation during
power mains interruptions, it is
recommended that the Welch Allyn
Home Blood Pressure Monitor be
powered from an uninterruptible
power supply or a battery.
Electromagnetic immunity
< 5% UT
Note: UT is the AC mains voltage prior to application of the test level.
IEC 61000-4-8
Power
frequency
(50Hz)
magnetic field
IEC 61000-4-11
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
60
Welch Allyn Home Blood Pressure Monitor
Electromagnetic immunity
150 kHz to
80 MHz
3 Vrms and
6 Vrms
Conducted RF
IEC 61000-4-6
IEC 60601
test level
Immunity
test
3 Vrms and
6 Vrms
Compliance
level
d = 1,2
P
Recommended separation
distance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Welch Allyn Home Blood Pressure
Monitor, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Electromagnetic environment guidance
The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch Allyn Home Blood
Pressure Monitor should assure that it is used in such an environment.
Directions for use 61
10 V/m
800 MHz to 2,5 GHz
800 MHz to 2,6 GHz
P
80 to 800 MHz
P
P
where P is the maximum output power
rating ofthe transmitter in watts (W)
and d is the recommended separation
distance in meters (m). Field
strengths from fixed RF transmitters,
as determined by an electromagnetic
site surveya should be less than the
compliance level in each frequency
rangeb. Interference may occur in the
vicinity of equipment marked with the
following symbol:
d = 2,3
80 MHz to
2,6 GHz
10 V/m
d = 1,2
d = 2,3
3 V/m
80 MHz to
2,5 GHz
IEC 61000-4-3
Electromagnetic immunity
3 V/m
Radiated RF
62
Welch Allyn Home Blood Pressure Monitor
Electromagnetic immunity
bOver
the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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 Welch Allyn Home Blood Pressure Monitor is used exceeds the applicable RF
compliance level above, the Welch Allyn Home Blood Pressure Monitor should be observed to verify
normal operation. If abnormal performance is observed,additional measures may be necessary, such as
reorienting or relocating the Welch Allyn Home Blood Pressure Monitor.
aField
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Directions for use 63
0.12
0.38
1.2
3.8
12
0.1
1
10
100
d = 1,2
P
12
3.8
1.2
0.38
0.12
d = 1,2
P
23
7.3
2.3
0.73
0.23
d = 2,3
P
Separation distance according to frequency of transmitter (m)
150 kHz to
80 MHz to
800 MHz to
80 MHz
800 MHz
2,6 GHz
0.01
(W)
Rated maximum
output power of
transmitter
The Welch Allyn Home Blood Pressure Monitor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or user of the
Welch Allyn Home Blood Pressure Monitor can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Welch Allyn Home Blood Pressure Monitor as
recommended below, according to the maximum output power of the communications
equipment.
Recommended separation distances between portable and mobile RF
communications equipment and the Welch Allyn Home Blood Pressure
Monitor
64
Welch Allyn Home Blood Pressure Monitor
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Recommended separation distances between portable and mobile RF
communications equipment and the Welch Allyn Home Blood Pressure
Monitor
Directions for use 65
Welch Allyn® Home
Blood Pressure Monitor
Model
T-H-BP100SBP
727404
DIR 80022409 Ver. B