Welch Allyn 901042 Directions For Use Manual
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
© 2016 Welch Allyn. All rights are reserved. To support the
intended use of the product described in this publication. The
purchaser of the product is permitted to copy this publication, for
internal distribution only, from the media provided 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 Copyright 2016 Welch Allyn or its
vendors. All rights are reserved. The software is protected by
United States of America copyright laws and international treaty
provisions applicable worldwide. Under such laws, the licensee is
entitled to use the copy of the software incorporated with this
instrument as intended in the operation of the product in which it
is embedded. The software may not be copied, decompiled,
reverse engineered, disassembled, or otherwise reduced to
human-perceivable form. This is not a sale of the software or any
copy of the software; all right, title, and ownership of the software
remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, contact Welch
Allyn Technical Support: http://www.welchallyn.com/
:
725435
DIR 80021551 Ver. C
Revision date:
2016-09
Manufactured for Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
This manual applies to the
901042 Automated Blood
Pressure System
Guangdong Transtek Medical Electronics Co., Ltd.
No. 105, Dongli Road
Torch Development District
Zhongshan, 528437, Guangdong, China
www.welchallyn.com
Directions for use i
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for use. . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . .3
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . .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
ii 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 blood pressure monitor
features blood pressure measurement via
SureBP
measurement, and data management
using Bluetooth
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 change of a reading failure.
®
Technology, pulse rate
®
Smart technology.
SureBP Technology is an
advanced blood pressure
measurement technology
that obtains a blood pressure
The design provides you with two years
of reliable service. Readings taken by the
monitor are equivalent to those obtained
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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
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
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 blood pressure device, the
packaging, the shipping container, or in
this Directions for use.
The Welch Allyn blood pressure device is
safe for patients and clinicians 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 patient 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 Patient injury risk. The
device is not suitable for measuring
the blood pressure of neonatal infants
or children.
WARNING Patient injury risk. The
device is not suitable for use on
pregnant women, patients with
implanted electrical devices, patients
with preeclampsia, premature
ventricular beats, atrial fibrillation,
peripheral arterial disease, and
patients 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 Patient 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 Patient 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 Patient 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 Patient injury risk. Do not
burn batteries. Batteries may leak or
explode.
WARNING Patient 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 Patient 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 Patient injury risk. This
unit is not suitable for continuous
monitoring during medical
emergencies or operations.
WARNING Patient injury risk. Taking
blood pressure measurements too
frequently could disrupt blood
circulation and cause injuries.
12
Welch Allyn Home Blood Pressure Monitor
WARNING Patient 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 Patient injury risk.
Never apply the cuff over
damaged skin. This can cause
further injury.
WARNING Patient injury risk. Do
not touch output of the batteries/
adapter and the patient
simultaneously.
WARNING Patient injury risk. Do
not use the unit if you are allergic
to polyester or synthetic
materials.
WARNING Patient injury risk.
Excessive tube lengths could
cause strangulation if you don't
manage them properly.
WARNING Patient 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 Patient injury risk.
Dispose of accessories,
detachable parts, and the device
according to the local guidelines.
Directions for use 13
WARNING Patient injury risk. Do
not service or perform any
maintenance while using the
device.
WARNING Patient injury risk. Use
only accessories approved by the
manufacturer. Using unapproved
accessories might cause damage
to the unit and injure patients.
WARNING Patient 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
16
Welch Allyn Home Blood Pressure Monitor
Controls and indicators
Monitor front
No. Feature Description
1 D-Ring
blood
pressure
cuff
2 Air tube Connects the cuff to the
3 Air
connector
plug
4 Power
button
Apply to upper arm to
take a blood pressure
measurement
air connector plug
Air tube connects to the
air connector plug
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
2 Battery
compartme
nt (behind
cover)
When used with an
accessory power cord
(not included), connects
the monitor to a power
outlet
Houses 4 AA alkaline
batteries
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)
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