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

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This manual applies to the 901042 Automated Blood Pressure System

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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

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

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

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

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.

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.

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.

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

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)

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