Welch Allyn Welch Allyn Home 1500 Series Manual

Welch Allyn Home 
Blood Pressure Monitor
1500 Series
Directions for use
901042 Automated Blood Pressure System
RPM-BP100
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.
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/
:
726882
DIR 80022180 Ver. A
Revised: 2017-04
This manual applies to the
901042 Automated Blood
Pressure System
Manufactured for Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallynhome.com

Directions for use iii
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . .iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for use. . . . . . . . . . . . . . . . . . . 1
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
Connect the blood pressure air tube . . . . 23
Pair a smartphone, a tablet, or a communication
hub with the monitor . . . . . . . . . . . . . . . . . . . . . .25
Position the blood pressure cuff . . . . . . . .26
Start the measurement . . . . . . . . . . . . . . . .28
Some points to remember about your blood
pressure device: . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Disconnect the blood pressure air tube. . . . . .32

iv Welch Allyn Home Blood Pressure Monitor
Blood pressure facts, pointers, and best
practices . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Helpful definitions . . . . . . . . . . . . . . . . . . . .33
Irregular heartbeat detector . . . . . . . . . . .33
Maintenance . . . . . . . . . . . . . . . . . . . . . . . 37
Maintain the monitor and cuff . . . . . . . . . . 37
Troubleshooting . . . . . . . . . . . . . . . . . . .38
Problems and error messages . . . . . . . . . .38
Technical alarms . . . . . . . . . . . . . . . . . . . . . .38
Physiological alarms. . . . . . . . . . . . . . . . . . . . . . .42
Specifications. . . . . . . . . . . . . . . . . . . . . .43
General radio compliance . . . . . . . . . . . . . .45
Federal Communication Commission (FCC)
Interference Statement . . . . . . . . . . . . . . . .45
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 1500 Series (blood pressure
monitor) is indicated for adult use in the
home or domestic setting only.
The design provides you with two years
of reliable service. Readings taken by the
monitor are equivalent to those obtained
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 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 22 cm to 42 cm
(approximately 9 to 17 inches).
The device detects the appearance of
irregular heartbeats during measurement
and gives a warning signal with readings.

2 Welch Allyn Home Blood Pressure Monitor
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.

Directions for use 3
Symbols
Documentation symbols
Power 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
Direct current
Power

4 Welch Allyn Home Blood Pressure Monitor
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

Directions for use 5
Blood pressure device and cuff
symbols
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, Model number
Non-ionizing electromagnetic
radiation
Global Trade Identification
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 arterio-
venous 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 self-
measurement station used in a public
place or center.
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 10993-
10:2010. 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
Contents list
The following items are in the device
box:
• Blood Pressure Monitor
• D-Ring Standard Wide Cuff (22cm
to 42cm / 9in to 17in) with air tube
attached
• (4) AA alkaline batteries
• Directions for use
• Quick reference guide
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.

Directions for use 15
Controls and indicators
Monitor front
No. Feature Description
1D-Ring
blood
pressure
cuff
Apply to upper arm to
take a blood pressure
measurement
2 Air tube Connects the cuff to the
air connector plug
3Air
connector
plug
Air tube connects to the
air connector plug
4Power
button
Powers on the monitor,
starts and stops a blood
pressure measurement,
and — when pressed for 2
seconds — initiates a
Bluetooth pairing

16 Welch Allyn Home Blood Pressure Monitor
Monitor back
5LCD
Display
Displays blood pressure
reading and other
pertinent information
regarding the reading
No. Feature Description
1Direct
current
power
connection
When used with an
accessory power cord
(not included), connects
the monitor to a power
outlet
2 Battery
compartme
nt (behind
cover)
Houses 4 AA alkaline
batteries
No. Feature Description