Welch Allyn H-BP100SBP User Manual

Welch Allyn Home



Blood Pressure Monitor

Directions for use

901042 Automated Blood Pressure System

Software version A01

ii Welch Allyn Home Blood Pressure Monitor

© 2019 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 © 2019 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:

:

749521
DIR 80025286 Ver. B
Revised: 2019-08

Distributed by Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA

hillrom.com

This manual applies to
the 901042
Automated Blood
Pressure System

hillrom.com

Directions for use iii

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications for use. . . . . . . . . . . . . . . . . . . 2

Contraindications . . . . . . . . . . . . . . . . . . . 2

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Documentation symbols . . . . . . . . . . . . . . . .3

Power symbols . . . . . . . . . . . . . . . . . . . . . . . . 3

Shipping, storing, and environment symbols . .4

Blood pressure device and cuff symbols . . . . . . 5

Miscellaneous symbols. . . . . . . . . . . . . . . . . . . . . .6

About warnings and cautions. . . . . . . . . 8

Warnings and cautions . . . . . . . . . . . . . . . . . 9

Contents list. . . . . . . . . . . . . . . . . . . . . . . . . . 14

Controls and indicators . . . . . . . . . . . . . . . . . . . . 15

Power options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Screen elements . . . . . . . . . . . . . . . . . . . 18

Measuring blood pressure . . . . . . . . . . . 21

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Set up your equipment . . . . . . . . . . . . . . . . 22

Pair a smartphone, a tablet, or a
communication hub with the monitor . . . 23

Position the blood pressure cuff . . . . . . . .25

Start the measurement . . . . . . . . . . . . . . . .26

Some points to remember about your

blood pressure device: . . . . . . . . . . . . . . . . 29

Blood pressure facts, pointers, and best

practices . . . . . . . . . . . . . . . . . . . . . . . . . .30

Helpful definitions . . . . . . . . . . . . . . . . . . . .30

Irregular heartbeat detector . . . . . . . . . . . 31

Maintenance . . . . . . . . . . . . . . . . . . . . . . . 35

iv Welch Allyn Home Blood Pressure Monitor

Maintain the monitor and cuff . . . . . . . . . . 35

Troubleshooting . . . . . . . . . . . . . . . . . . . 36

Problems and error messages . . . . . . . . . .36

Technical alarms . . . . . . . . . . . . . . . . . . . . . .36

Physiological alarms . . . . . . . . . . . . . . . . . . . . . . .39

Specifications. . . . . . . . . . . . . . . . . . . . . 40

General radio compliance . . . . . . . . . . . . . .42

Federal Communication Commission (FCC)

Interference Statement . . . . . . . . . . . . . . . .43

FCC Radiation Exposure Statement . . . . .44

Industry Canada (IC) compliance . . . . . . .44

Complied standards list . . . . . . . . . . . . . . . . . . . .47

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . .50

Approved accessories . . . . . . . . . . . . . . 52

Emissions and immunity information . 53

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
pulse rate measurement, and data
management using Bluetooth
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

®

Technology,

®

Smart

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).

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.

Symbols

Documentation symbols

Directions for use 3

War ning

manual identify conditions or practices
that could lead to illness, injury, or death.

Caution

manual identify conditions or practices
that could result in damage to the
equipment or other property, or loss of
data.

Mandatory - Consult Directions for Use

: The warning statements in this

: The caution statements in this

Power symbols

Direct current (DC)

Stand-By

4

Welch Allyn Home Blood Pressure Monitor

Shipping, storing, and environment
symbols

Humidity limitation

Separate collection of Electrical and
Electronic Equipment. Do not dispose
as unsorted municipal waste.

Temperature limit

Atmospheric pressure limitation

Recyclable

Stacking limit by number

Directions for use 5

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

6

Welch Allyn Home Blood Pressure Monitor

Miscellaneous symbols

Type BF applied part

Serial Number

Product Identifier

Manufacturer

Reorder Number

Non-ionizing electromagnetic
radiation

Global Trade Item Number

Class II equipment

Directions for use 7

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

8

Welch Allyn Home Blood Pressure Monitor

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

Directions for use 9

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.

10

Welch Allyn Home Blood Pressure Monitor

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.

Directions for use 11

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.

12

Welch Allyn Home Blood Pressure Monitor

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.

Directions for use 13

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.

14

Welch Allyn Home Blood Pressure Monitor

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

Controls and indicators

Monitor front

No. Feature Description

1D-Ring

blood
pressure
cuff

2Power

button

3LCD

Display

Apply to upper arm to
take a blood pressure
measurement

Powers on the monitor,
starts and stops a blood
pressure measurement,
and — when pressed for 2
seconds — initiates a

Bluetooth

Displays blood pressure
reading and other
pertinent information
regarding the reading

Directions for use 15

pairing

16

Welch Allyn Home Blood Pressure Monitor

Monitor back

No. Feature Description

1 Direct current

power
connection

2 Battery

compartment
(behind
cover)

When used with an
accessory power
cord (not included),
connects the
monitor to a power
outlet

Houses 4 AA
alkaline batteries

Directions for use 17

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)

18

Welch Allyn Home Blood Pressure Monitor

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.

Directions for use 19

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

20

Welch Allyn Home Blood Pressure Monitor

Symbol Description

Bluetooth

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)

connectivity status

Directions for use 21

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.

22

Welch Allyn Home Blood Pressure Monitor

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.

Directions for use 23

2. Install the batteries by matching the

polarity as shown in the diagram.

3. Replace the cover.

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

24

Welch Allyn Home Blood Pressure Monitor

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
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.

Directions for use 25

Note

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.

The preferred site for taking a
blood pressure measurement is
your bare upper arm.

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,

26

Welch Allyn Home Blood Pressure Monitor

and the tube and artery marker
should appear on your arm as shown

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.

Directions for use 27

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.

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.

28

Note

Welch Allyn Home Blood Pressure Monitor

If 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.

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.

Directions for use 29

Note

Note

For 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.

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.

Remove and attach a blood pressure
cuff

The air tube remains connected to
the blood pressure monitor at all
times, but you can remove and
attach blood pressure cuffs as
follows.

30

Welch Allyn Home Blood Pressure Monitor

1. To remove a connected cuff, gently

pull the air tube connector away
from the cuff connector.

2. To attach a cuff, gently press the

cuff connector into the air tube.

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

Directions for use 31

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.

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.

32

Welch Allyn Home Blood Pressure Monitor

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.

Directions for use 33

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

34

Welch Allyn Home Blood Pressure Monitor

and before taking a blood pressure
measurement

• Sitting still during measurement

• Not talking during measurement

• Waiting at least 3 minutes between

measurements

Directions for use 35

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:

• 70% isopropyl alcohol

• 10% chlorine bleach/90% water
solution (standard bleach wipe)

2. If necessary, you may wipe the cuff
with a soft, damp cloth.

36

Welch Allyn Home Blood Pressure Monitor

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

No power Display will

not light up

cause

Batteries are
drained.

Batteries are
inserted
incorrectly.

AC ad apter
is inserted
incorrectly

Solution

Replace
with new
batteries

Insert the
batteries
correctly

Insert the
AC ad apter
tightly

Directions for use 37

Problem Symptom Root

cause

Low
batteries

Error
messages

The display
indicates
the “BAT­LO”
message,
pauses for
3 seconds.
The battery
icon shows
empty
(does not
flash).

E 01 shows The cuff is

E 03 shows There is too

E 10 or E 11
shows

Batteries are
low.

not secure,
the cuff is
too tight, or
a leak is
detected.

much
pressure in
the cuff

The monitor
detected
motion while
measuring

Solution

Replace
with new
batteries.

Readjust
the cuff,
have the
patient
relax for a
moment,
and then
measure
again.
Inspect the
connection
tube for
leaks or
kinks.

Refasten
the cuff and
then
measure
again

Readjust
the cuff,
relax for a
moment,
and then
measure
again

38

Welch Allyn Home Blood Pressure Monitor

Problem Symptom Root

cause

Visit

hillrom.com

EE or E 19
shows

Hardware
error

for further assistance.

Solution

Measure
again. If
the
problem
persists,
contact
the
retailer
or
Wel ch
Allyn
customer
service
at

hillrom.com

for
further
assistance.

Physiological alarms

Symptom Root cause Solution

Out of range.
Either SYS
>260mmHg or
DIA
>220mmHg.
The symbol
may appear in
either the SYS
or DIA area of
the screen.

Out of range.
Either SYS
<50mmHg or
DIA <25mmHg.
The symbol
may appear in
either the SYS
or DIA area of
the screen.

Directions for use 39

Press and
hold the

Power

button to
reestablish

Bluetooth

connectivity.
Measure
again. If the
problem
persists,
contact your
physician.

Alarm
priority =
Low

Press and
hold the

Power

button to
reestablish

Bluetooth

connectivity.
Measure
again. If the
problem
persists,
contact your
physician.

Alarm
priority =
Low

40

Welch Allyn Home Blood Pressure Monitor

Specifications

Item Specification

Power supply:
Battery powered
mode:

Power supply: AC
adapter powered
mode:

Power supply model
number

Display mode Digital LCD

Measurement model Oscillometric testing

Measurement range Rated cuff pressure:

Accuracy Pressure:

6VDC 4*AA batteries

Input: 100-240V, 50­60Hz, 400mA;
Output: 6V, 1A

UE08WCP­060100SPA

V. A. 6 8 mm * 90 m m

mode

0mmHg to
300mmHg (0kPa­40kPa)
Measurement
pressure:
SYS: 50 to 260mmHg
DIA: 25 to 220mmHg
Pulse value: (40 to

199)beat/minute

±0.4kPa (3mmHg)
Pulse value:±4%

Directions for use 41

Item Specification

Normal working
conditions

Storage and
transportation
condition

Tem pe ra tu re : 5 °C to
40°C
Relative humidity

85% RH
Atmospheric
pressure: 86kPa to
106kPa

Tem pe ra tu re :- 20 °C to
60°C
Relative Humidity:
10% RH–93% RH
Atmospheric
Pressure: 50kPa to
106 kPa

Circumferen ce of the
upper arm

Part
Number

D-Ring
Extra
Small Cuff
BPACC-01

Cuff size

15–24cm

D-Ring
Standard
Wide Cuff
BPACC­02

D-Ring
Extra
Large
Cuff
BPACC­03

22–42cm

40–54cm

42

Welch Allyn Home Blood Pressure Monitor

Item Specification

Net Weight Approx. 283g

(Excluding the dry
cells)

External dimensions Approx. 94mm

*142mm*66mm

Degree of protection Type BF applied part

Protection against
ingress of water

IP22

Software Version Version A01

General radio compliance

Item Specification

Bluetooth

No.

Radio Frequency
(RF) Range

Output Power 4.0 dBm

Supply Voltage 1.8V to 3.6V

Antenna Gain 0.0 dBi

Transmitting
Distance

Module

AW5182 2

2402 MHz to 2480 MHz

10 meters (30 feet)

Directions for use 43

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

44

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 45

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

46

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 47

Complied standards list

Item Standard

Risk
management

Labeling ISO/EN 15223-1 Medical

User manual EN 1041 Medical

General
Requirements
for Safety

ISO/EN 14971 Medical
devices — Application of
risk management to
medical devices

devices. Symbols to be
used with medical device
labels, labeling and
information to be
supplied. General
requirements

equipment manufacturers
to provide information

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

48

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 49

Item Standard

Usability IEC 62366 Medical

Small-bore
connectors

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

IEC 80369-5 Small-Bore
Connectors for Liquids
and Gases in Healthcare
Applications - Part 5:
Connectors for Limb Cuff
Inflation Applications

50

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 51

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
[e-mail].

52

Welch Allyn Home Blood Pressure Monitor

Approved accessories

Item Description

BPACC-01 D-Ring Extra Small Cuff

BPACC-02 D-Ring Standard Wide

BPACC-03 D-Ring Extra Large Cuff

107041 ProBP 2000 adapter

(15–24cm)

Cuff (22-42cm)

(40–54cm)

set. This adapter is an
alternate power source
for the blood pressure
monitoring device.

Electromagnetic emissions

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.

Directions for use 53

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.

Compliance 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).

Group 1 The Welch Allyn Home Blood Pressure Monitor uses RF

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.

Emissions

test

RF emissions

CISPR 11

Emissions and immunity information

54

Welch Allyn Home Blood Pressure Monitor

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

Class B The Welch Allyn Home Blood Pressure Monitor is

Class A

Complies

RF emissions

CISPR 11

Harmonic

emissions

IEC 61000-3-2

Voltage

fluctuations/

flicker

emissions

IEC 61000-3-3

Electromagnetic immunity

Electromagnetic environment -

Compliance

IEC 60601

guidance

level

test level

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative

humidity should be at least 30%.

±8 kV contact

± 15kV air

±8 kV contact

± 15kV air

Directions for use 55

Mains power quality should be that of

a typical commercial or hospital

±2 kV for

±2 kV for

environment.

power supply

lines

power supply

lines

Mains power quality should be that of

± 1 kV

±1 kV for input/

output lines

± 1 kV line(s) to

a typical commercial or hospital

differential

line(s)

environment.

mode

± 2kV line(s) to

earth

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.

Immunity

test

Electrostatic

discharge

(ESD)

IEC 61000-4-2

Electrical fast

transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

56

Welch Allyn Home Blood Pressure Monitor

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.

)

)

T

T

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical

commercial or hospital environment.

T

< 5% U

Electromagnetic immunity

T

< 5% U

Voltage dips,

short

(>95% dip in

(>95% dip in

interruptions

T

T

) for 0.5

T

U

cycle

) for 0.5

T

U

cycle

and voltage

variations on

40% U

40% U

power supply

input lines

for 5 cycles

70% U

(60% dip in U

)

T

T

T

70% U

for 5 cycles

(60% dip in U

IEC 61000-4-11

T

) for 5

for 25 cycles

(30% dip in U

)

T

for 25 cycles

(30% dip in U

T

(>95% dip in

U

seconds

3A/m and

< 5% U

T

< 5% U

(>95% dip in

30 A/m

) for 5

T

3A/m and

30 A/m

U

seconds

Power

frequency

(50Hz)

magnetic field

IEC 61000-4-8

Note: UT is the AC mains voltage prior to application of the test level.

Directions for use 57

P

Electromagnetic environment -

guidance

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.

Compliance

level

= 1,2

Recommended separation

distance

d

3 Vrms and

6Vrms

Electromagnetic immunity

IEC 60601

The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic

test level

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.

Immunity

test

3 Vrms and

6Vrms

150 kHz to

Conducted RF

IEC 61000-4-6

80 MHz

58

PPP

Welch Allyn Home Blood Pressure Monitor

800 MHz to 2,5 GHz

80 to 800 MHz

= 1,2

= 2,3

d

d

800 MHz to 2,6 GHz

= 2,3

d

where P is the maximum output power

should be less than the

a

the transmitter in watts (W)

is the recommended separation

d

and

rating of

. Interference may occur in the

b

compliance level in each frequency

range

distance in meters (m). Field

strengths from fixed RF transmitters,

as determined by an electromagnetic

site survey

vicinity of equipment marked with the

following symbol:

3 V/m

10 V/m

Electromagnetic immunity

10 V/m

80 MHz to

3 V/m

80 MHz to

2,5 GHz

Radiated RF

IEC 61000-4-3

2,6 GHz

Electromagnetic immunity

Directions for use 59

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

absorption and reflection from structures, objects, and people.

a

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

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

normal operation. If abnormal performance is observed,additional measures may be necessary, such as

reorienting or relocating the Welch Allyn Home Blood Pressure Monitor.

b

60

PPP

Welch Allyn Home Blood Pressure Monitor

= 2,3

800 MHz to

2,6 GHz

d

= 1,2

80 MHz to

800 MHz

d

= 1,2

Separation distance according to frequency of transmitter (m)

150 kHz to

80 MHz

d

Recommended separation distances between portable and mobile RF

communications equipment and the Welch Allyn Home Blood Pressure

Monitor

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.

Rated maximum

output power of

transmitter

(W)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100121223

is the maximum output power rating of the

P

in meters (m) can be estimated using the equation applicable to the

d

Directions for use 61

Recommended separation distances between portable and mobile RF

communications equipment and the Welch Allyn Home Blood Pressure

Monitor

transmitter in watts (W) according to the transmitter manufacturer.

frequency of the transmitter, where

For transmitters rated at a maximum output power not listed above, the recommended

separation distance

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.

Welch Allyn® Home

™

Blood Pressure Monitor

Model: H-BP100SBP

749521
DIR 80025286 Ver. B