Philips Medical Systems North America M3815A2 Home Blood Pressure Transmitter User Manual manual

Philips Medical Systems North America Co. Home Blood Pressure Transmitter manual

manual

Blood Pressure Unit

User Guide

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Blood Pressure Unit Quick Start

Before You Start

• Make sure you read and understand the Blood Pressure Unit

User Guide.

Taking Your Blood Pressure

To begin, sit down, put on the blood pressure cuff, and press the

START/STOP button. Your blood pressure (BP) is measured and

displayed automatically.

1. Sit comfortably with your left forearm resting on a flat surface

so that the center of your upper arm is at about the same height

as your heart.

2. Loosen the blood pressure cuff so that you can slide the cuff

over your arm. Place your hand into the cuff.

3. Slide the cuff up your forearm.

4. As you slide the cuff on, position the cuff so that the bottom of

the cuff is on your upper arm and about one inch above the

elbow crease; make sure that the air hose dangles

on the inside of your arm.

5. Pull on the cuff end to tighten it. The cuff does not have to be

pulled very tight. For comfort, you can leave room for one fin-

ger to fit under the cuff.

6. Fold the cuff end back over the metal D-ring, and fasten the

cuff end to the Velcro®closure.

7. Press the START/STOP button. Sit still and do not move your

arm during the measurement. If you want to stop the measure-

ment at any time, press the START/STOP button. Wait 15 min-

utes before taking your blood pressure again.

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BP User Guide

8. A series of numbers and symbols appear in the display window.

The cuff inflates and may feel tight. A long beep signals the end of

the BP measurement and the cuff deflates. The display window

shows your final BP measurement and pulse rate.

WARNING: As you watch the display, if you notice the pressure

increase above 330 mmHg OR if the pressure decreases and remains

at 15 mmHg for more than 3 minutes, press the START/STOP but-

ton to stop the measurement. The BP Unit is defective. Contact your

Health Care Provider.

9. You can remove the cuff. The BP Unit has taken your blood pres-

sure and pulse rate. The BP Unit turns off automatically.

Note: Do not store the BP Unit with the air hose twisted or wrapped

tightly around the display.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 3

Notice

The information contained in this document is subject to change

without notice.

Agilent Technologies makes no warranty of any kind with regard to this

material, including, but not limited to, the implied warranties of mer-

chantability and fitness for a particular purpose. Agilent Technologies

shall not be liable for errors contained herein or for incidental or conse-

quential damages in connection with the furnishing, performance, or use

of this material.

Agilent Technologies assumes no responsibility for the use or

reliability of its software on equipment that is not furnished by

Agilent Technologies.

This document contains proprietary information that is protected by

photocopied, reproduced, or translated to another language without

the prior written consent of Agilent Technologies.

Agilent Technologies, Inc.

3000 Minuteman Rd.

Andover, MA 01810

USA

Note: All Agilent devices must be initially installed by an Agilent

installer or responsible party. The installation information provided in

this guide is for reference only.

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Table of Contents

BP User Guide

Blood Pressure Unit Quick Start ........................................2

Notice ....................................................................................4

Introduction ..........................................................................6

Precautions ............................................................................7

BP Unit Symbols ..................................................................9

BP Unit Components..........................................................10

Installation ..........................................................................12

Installation Setup ..........................................................12

Inserting Four Type AA (1.5 Volt) Alkaline

Batteries ........................................................................13

Performing a Radio Test................................................15

Preparing the Cuff Assembly ........................................17

How to Take Your Blood Pressure ....................................18

Taking Your Blood Pressure..........................................19

What Display Symbols Mean ............................................26

Maintenance........................................................................27

Troubleshooting ..................................................................28

Specifications ......................................................................30

Electromagnetic Compatibility ........................................32

Electromagnetic Compatibility Testing ....................32

Avoiding Electromagnetic Interference Problems ..33

FCC Regulations ................................................................34

Conclusion ..........................................................................35

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Welcome to Agilent Technologies’ Interactive Healthcare Services. Your

Health Care Provider has enrolled you in a progressive program to mea-

sure, transmit, and review your vital signs on a daily basis. This pro-

gram’s approach will help you and your provider make better informed

decisions about your care.

Your patient measurement set—which may include a Scale, Blood

Pressure Unit, Rhythm Strip Recorder, and Home Hub—is designed to

let you quickly and easily take your vital signs. The data you collect in

a few minutes each day are automatically transferred via the Agilent

Home Hub, using your existing phone line, to your Health Care

Provider’s computer system. The Home Hub is smart enough to know

when you’re not on the phone, and that’s when it will make the data

transfer. You do not need to do anything. Feel free to use the phone at

any time. The Home Hub also recognizes if the connection was inter-

rupted and will automatically re-transmit stored information later.

If any of the devices in your patient measurement set is not functioning

properly, please advise your Health Care Provider and Agilent will

repair or replace the device.

As a user of Interactive Healthcare Services, you are taking an active

role in providing your Health Care Provider with accurate, relevant, and

timely information—information we expect will go a long way toward

improving your quality of life.

The Blood Pressure Unit User Guide explains how you can measure your

blood pressure and pulse rate from the convenience and comfort of your

own home. This guide provides you easy-to-understand information about

operation and maintenance. Agilent and your Health Care Provider appre-

ciate your efforts to actively participate in your home health care plan.

Introduction

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Precautions

BP User Guide

• It is important that you use this Blood Pressure Unit (BP Unit) as

directed by your Health Care Provider. This BP Unit is provided for

your personal use only. Please do not allow others to use this BP

Unit.

• Your Health Care Provider will tell you when and how often to take

your blood pressure. Please follow your Health Care Provider’s

directions carefully. Report any change in the way you take your

blood pressure (BP) to your Health Care Provider.

• Follow your physician’s instructions regarding symptoms that require

direct contact with your Health Care Provider. Keep in mind that use

of this BP Unit is not a substitute for medical care. Only your Health

Care Provider is qualified to interpret the results. If you have any

questions regarding how to use your BP Unit, please contact your

Health Care Provider.

•Caution: Avoid storing your BP Unit inside a metal container or

drawer, such as a file cabinet.

•Caution: Do not attempt to service or repair the BP Unit yourself.

If a mechanical problem occurs, contact your Health Care Provider

for further instructions.

•WARNING: It is important for you to watch the display when taking

your blood pressure measurement. If the numbers go up to 330

mmHg, press the START/STOP button to stop the measurement.

The BP Unit is defective. Contact your Health Care Provider for fur-

ther instructions.

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Precautions

•WARNING: As you watch the display when taking your blood pres-

sure measurement, if the BP numbers drop down to 15 mmHg and

stay that way for more than 3 minutes, press the START/STOP but-

ton to stop the measurement. The BP Unit is defective. Contact your

Health Care Provider for further instructions.

• If you received an error message, aborted the BP measurement while

in progress, or feel that the reading might be in error, wait 15 min-

utes before taking your blood pressure again.

•Caution: Avoid storing the BP Unit where children or pets have

access to it. There may be a risk of injury if children or pets get

tangled in the air hose or if the cuff inflates.

•WARNING: Do not allow children to use this BP unit. This BP unit

is intended for the patient only.

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Blood Pressure Unit Symbols

BP User Guide

Symbol Definitions

Type B Patient Applied Parts as defined in IEC 60601-1.

Not suitable for direct cardiac application.

Attention: Consult accompanying documents.

Complies with Canadian Standards Association.

Complies with Class B standard.

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Blood Pressure Unit Components

The BP Unit is made up of the BP

Unit and a cuff assembly. An air

socket is on one side of the BP

Unit. The cuff assembly has a cuff

(with metal D-ring) and an air

hose (with air connector).

The BP Unit face has a

START/STOP button, a display

window (for the BP and pulse

measurement), and a Radio Test

button.

Radio Test button

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Blood Pressure Unit Components

BP User Guide

The BP Unit back has a battery compartment.

Storage Between Uses

Store the BP Unit so that the hose is not bent. Do not wrap the hose

around the BP display unit.

Battery compartment

Right Way Wrong Way

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Installation

• Locate and store your BP Unit within 20 feet of the Home Hub. In

addition to transmitting data when you take your blood pressure,

your BP Unit sends periodic updates to the Home Hub.

• Hazards for children are packing materials that can be swallowed or

plastic bags that can be pulled over the head. Discard and safely dis-

pose of these materials immediately.

•Caution: Avoid storing the BP Unit where children or pets have

access to it. There may be a risk of injury if children or pets get

tangled in the air hose or if the cuff inflates.

•Caution: Avoid storing your BP Unit inside a metal container or

drawer, such as a file cabinet.

Installation Setup

The measurements you take cannot be transmitted to your Health Care

Provider until you install the Home Hub.

You must install the Home Hub before you set up the BP Unit. Refer to

the Home Hub User Guide.

After you have performed the installation for the Home Hub, insert

alkaline batteries into the BP Unit, perform the Radio Test, and prepare

the cuff assembly. Then, you must return to the Home Hub User Guide

and complete the connection steps.

WARNING: Do not allow children to use this BP unit. This BP unit is

intended for the patient only.

It is important to take your blood pressure as instructed by your Health

Care Provider. Your Health Care Provider may contact you if they do

not receive blood pressure measurements as scheduled.

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Installation

BP User Guide

Inserting Four Type AA (1.5 Volt) Alkaline Batteries

Caution: Use alkaline batteries only. Replace all four batteries at the

same time. Do not use rechargeable batteries. Always replace old

batteries with four new batteries.

WARNING: Do not use this equipment with the battery door removed.

1. Remove the battery compartment cover on the back of the BP

Unit by gently lifting up the tab marked with the arrow symbol

and popping the cover off.

Arrow symbol

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Installation

2. Place the batteries in the compartment with the positive (+) and

negative (-) terminals matching those shown in the compart-

ment. To prevent the batteries from popping out, insert the bat-

teries in the bottom row first. Make sure that the battery termi-

nals make contact with the compartment terminals.

3. Replace the cover by inserting its tabs into the slots of the com-

partment and gently pressing the cover into place.

4. Perform a Radio Test as described in the next section.

Bottom row

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Installation

BP User Guide

Performing a Radio Test

Perform a Radio Test when you set up the BP Unit, change batteries,

or change the testing location.

1. The Radio Test button appears as a circle with a “T” inside it on

the lower left of the display (for SYSTOLIC, DIASTOLIC,

PULSE) on the front of the BP Unit. Press and hold the Radio

Test button for at least 3 to 5 seconds until the

Home Hub starts beeping (at a rate of one beep per second).

Note: If the Home Hub’s using phone light turns on while performing

the Radio Test, stop and wait until the using phone light turns off

before resuming the Radio Test.

2. If the Home Hub does not beep, determine if there are any

obstacles (such as large metal objects) between the BP Unit and

the Home Hub.

Radio Test button

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Installation

3. If obstacles are present, move the BP Unit so that no obstacles

are between the BP Unit and the Home Hub. If no obstacles

are present, move the BP Unit closer to the Home Hub.

4. Press and hold the Radio Test button until the Home Hub

beeps. If the Home Hub does not beep within 5 seconds, con-

tact your Health Care Provider.

Note: If you accidentally press the Radio Test button, it is OK.

If you are performing the Radio Test for the first time, stop now and return to the

Home Hub User Guide, and then complete the steps to connect the Home Hub.

Otherwise, you can begin using your BP Unit as usual.

Preparing the Cuff Assembly

1. Insert the air connector at

the end of the air hose into

the socket on the side of the

BP Unit. Gently rotate the

air connector as you insert it

into the socket. You should

feel the air connector snap

into place.

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Installation

BP User Guide

2. If the cuff has not been threaded through the metal D-ring,

thread the cuff end through now. Then, fold the cuff end back

over the D-ring so that the end fastens to the

Velcro®closures.

The BP Unit is now ready for use.

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How to Take Your Blood Pressure

To begin, sit down, put on the BP cuff, and press the START/STOP

button. Your blood pressure is measured and displayed automatically.

Caution: Do not talk or move during the measurement.

Before you take your BP measurement, do the following:

• Sit within 20 feet of the Home Hub.

• Relax for about 15 minutes.

• Remove restrictive clothing or roll up a loose garment sleeve. You

will be placing the cuff on your bare upper arm.

• Use the left arm for the BP measurement unless instructed otherwise

by your Health Care Provider.

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BP User Guide

How to Take Your Blood Pressure

Taking Your Blood Pressure

1. Sit comfortably with your left forearm resting on a flat surface

so that the center of your upper arm is at about the same height

as your heart.

Note: If you desire, you may lie down while someone else takes your

blood pressure.

It is important to be consistent in the way you take your blood

pressure (either sitting or lying down). Report any changes in

how you take your blood pressure to your Health Care Provider

immediately.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 19

How to Take Your Blood Pressure

2. Place your hand into the cuff.

3. Slide the cuff up your forearm.

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BP User Guide

How to Take Your Blood Pressure

4. As you slide the cuff on,

position the cuff so that it is

on your upper arm and the

bottom of the cuff is about 1

inch above the elbow

crease; make sure that the

air hose dangles on the

inside of your arm.

WARNING: Do not allow the air hose to kink or twist while you are

taking your blood pressure.

5. Pull on the cuff end to tight-

en it, and fold the cuff end

back over the metal D-ring.

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How to Take Your Blood Pressure

Note: The cuff should be snug but not tight. For comfort, you can leave

room for one finger to fit under the cuff.

6. Fasten the cuff end to the

Velcro®closure.

7. Make sure that your hand is

open, relaxed, and palm up.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 22

BP User Guide

How to Take Your Blood Pressure

8. Press the START/STOP button. Sit still and do not move your

arm during the measurement.

Note: If you want to stop the measurement at any time, press the

START/STOP button. Wait 15 minutes before taking your blood

pressure again.

9. Watch the display window. A series of numbers and symbols

will appear in the display window. The cuff inflates and may

feel tight. The BP Unit displays pressure numbers that change

and increase to just beyond 150 mmHg.

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How to Take Your Blood Pressure

WARNING: It is important for you to watch the display. If the numbers

go up to 330 mmHG, press the START/STOP button to stop the mea-

surement. The BP Unit is defective. Contact your Health Care Provider

for further instructions.

10. As the cuff pressure automatically decreases, watch the dis-

play screen. The BP Unit emits a series of beeps while the

pressure decreases.

WARNING: As you watch the display, if the BP numbers drop

down to 15 mmHg and stay that way for more than 3 minutes, press

the START/STOP button to stop the measurement. The BP Unit is

defective. Contact your Health Care Provider for further instruc-

tions.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 24

BP User Guide

How to Take Your Blood Pressure

11. A long beep signals the end of the BP measurement and the

cuff deflates. The display window shows your final BP mea-

surement and pulse rate.

Note: If you received an error message, stopped the BP measurement

while in progress, or feel that the reading might be in error, wait 15

minutes before taking your blood pressure again.

12. You can remove the cuff. The BP Unit has taken your blood

pressure and pulse rate. The BP Unit turns off automatically.

Note: Do not store the BP Unit with the air hose twisted or wrapped

tightly around the display.

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What Display Symbols Mean

DISPLAY SYMBOLS EXPLANATION

Appears during the blood pressure measure-

ment; blinks and beeps with each detected

pulse beat

Appears when the batteries need to be replaced;

also appears briefly at the start of your blood

pressure measurement

When an error message appears, check your

equipment, wait 15 minutes and retake your

blood pressure before contacting your Health

Care Provider. You may be able to troubleshoot

these error messages as described later in the

Troubleshooting section.

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BP User Guide

Maintenance

Replace the batteries when instructed to by your Health Care Provider

or when you see the Low Battery symbol on the BP Unit display.

Caution: Avoid exposing the BP Unit to extremes in temperature,

humidity, direct sunlight, shock, dust, spills, or standing water.

Clean the BP Unit only as required. Clean the BP Unit with a dry, soft

cloth or a soft cloth dampened with tap water and mild detergent, if

desired. Never use alcohol, acetone, benzene, thinner, or other harsh

chemicals to clean the BP Unit, cuff, or air hose.

Caution: Avoid storing the BP Unit so that the cuff assembly is twisted

or folded tightly.

Caution: Avoid tugging at the air hose or carrying the BP Unit by the

air hose.

Caution: Avoid storing the BP Unit where children or pets have access

to it. There may be a risk of injury if children or pets get tangled in the

air hose or if the cuff inflates.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 27

Troubleshooting

The only user-serviceable parts are the batteries.

Caution: Do not attempt to service or repair the BP Unit yourself. If a

mechanical problem occurs, contact your Health Care Provider for fur-

ther instructions.

When an error message appears, check your equipment and retake your

blood pressure before contacting your Health Care Provider. Remember

to relax for 15 minutes before taking your BP again.

You may be able to perform minor troubleshooting when error messages

appear on the display.

DISPLAY SYMBOL CONDITION/CAUSE CORRECTIVE ACTION

Appears when the

systolic and diastolic mea-

surements are

within 10 mmHg of

each other

Appears if the pressure

value is unstable due to

movement during reading

Check for air leakage;

check that the air hose

is properly connected by

unplugging it and firmly

replugging it in.

Wait 15 minutes, and

then take your blood

pressure again BUT

remain very still.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 28

Troubleshooting

BP User Guide

If you are unable to troubleshoot these error messages by follow-

ing these corrective actions, contact your Health Care Provider for

further instructions.

If your BP Unit is defective or no longer necessary, please contact

your Health Care Provider.

DISPLAY SYMBOL CONDITION/CAUSE CORRECTIVE ACTION

Appears if the pressure

value did not increase

during cuff inflation or if

the cuff is not fastened

Appears if the air connec-

tor of the air hose is not

inserted properly into the

BP Unit socket

Appears when the battery

voltage is too low for the

BP Unit to work properly

Check that the air hose

is properly connected by

unplugging it and firmly

replugging it in. Make

sure the cuff is securely

fastened.

Refer to step 1 of

Preparing the Cuff

Assembly. Check that

the air hose is properly

connected by unplugging

it and firmly replugging it

in.

Replace all four batteries

immediately and perform

a Radio Test.

Socket

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Specifications

Model M3815A

Type • Oscillometric

• Type B Patient Applied Part

• IPXO Ordinary Equipment

• Continuous operation

Display • Digital, 16 mm character height

• Pressure/pulse displayed simultaneously

Measurement range • Pressure: 20 to 280 mmHg

• Pulse: 40 to 200 pulses per minute

Accuracy • Pressure; ±4 mmHg or 2%, whichever is greater

• Pulse ±6%

Pressurization Automatic, using micropump

Depressurization Constant-air release-valve system

Deflation Automatic exhaust

Power source Four type AA (1.5 volt) alkaline batteries connected

in series (6.0 volts), included

Battery Life Approximately 6 months with 1 daily measurement

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BP User Guide

Specifications

Operating environment • 50º to 104º F (10º - 40º C)

• Less than 85% relative humidity

• Atmospheric altitude pressure 5.72 - 1013 hPa

(0 - 15,000 feet or 0 - 4,600 meters of altitude)

• WARNING: This equipment is not suitable for

use in the presence of flammable anaesthetic

mixture with air or with oxygen or nitrous oxide.

Storage environment • 15º to 130º F (-9º - 54º C)

• Less than 85% relative humidity

• Atmospheric pressure 572 - 1013 hPa

(0 - 15,000 feet or 0 - 4,600 meters of altitude)

Dimensions (approx.) • Length: 6.5” (165 mm)

• Width: 4.4” (112 mm)

• Height: 2.7” (69 mm)

Weight (approx.) 1 lb., 4 oz. (570 gms) with batteries

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 31

Electromagnetic Compatibility

The electromagnetic compatibility (EMC) validation of the M3815A

Blood Pressure Unit included testing performed according to the inter-

national standard for EMC with medical devices. See the

Manufacturer’s Declaration for details.

Electromagnetic Compatibility Testing

During the test program, the BP Unit was subjected to many EMC tests,

including both international standard and Agilent proprietary tests.

During most of the testing, no anomalies were observed.

For one of the tests, EN 61000-4-3 Radiated Immunity reduced perfor-

mance was observed. EN 61000-4-3 specifies that the product be sub-

jected to a field of 3 Volts/meter over a frequency range of 26 to 1000

MHz with no degradation of performance or loss of function below the

performance level specified when equipment is operated as intended. At

many of the test frequencies over the specified range, no anomalies

were observed. However, at a number of test frequencies, radio commu-

nications from the BP Unit to the M3812A Home Hub was disrupted.

These reduced levels are as low as 0.48 V/m in the range from 902.278

MHz to 948.302 MHz.

The phenomena discussed above are not unique to this BP Unit, but are

characteristic of radio instrumentation in use today. The Home Hub is a

radio receiver, and its reception of M3815A BP Unit signals can be

degraded by electromagnetic interference.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 32

BP User Guide

Electromagnetic Compatibility

Avoiding Electromagnetic Interference Problems

Eliminating or moving the source of interference can prevent electro-

magnetic interference. Possible sources of interfering radio frequency

radiation are cellular telephones, cordless telephones, or other products

that contain radio transmitters. The BP Unit has a Radio Test button

that sends a reduced strength test radio signal to the Home Hub, which

sounds an audio tone if the test signal is successfully received. This test

can be used to determine whether sources of interference are present.

These sources can be turned off or moved away to reduce their strength

and reduce interference. In addition, the BP Unit and the Home Hub can

be placed closer to each other so that the radio transmission from the

BP Unit to the Home Hub has less distance to travel and interfering

radio signals have less effect. The radio transmission from the BP Unit

is repeated periodically so that an intermittent source of interference

should only delay, not prevent, reception.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 33

FCC Regulations

This equipment 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. If it is not installed and used in

accordance with the instructions, it might 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 turning the equipment off and on, the user is encouraged

to try to correct the interference by one or more of the following mea-

sures:

• Re-orient or relocate the Home Hub.

• Increase separation between the measurement devices or the Home

Hub and the device being interfered with; e.g., the television.

• Consult your Health Care Provider.

Note: Any changes or modifications to the equipment that are not

expressly approved by Agilent could void the user’s authority to operate

this equipment.

M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 34

BP User Guide

Conclusion

Agilent and your Health Care Provider appreciate your efforts to partici-

pate in your home health care plan. By learning about and using the

Blood Pressure Unit as directed, you actively participate in your Health

Care Provider’s plan to keep track of your important measurements.

If you have any problems or questions, please contact your Health

Care Provider.

If desired, place Health Care Provider information label here.

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M3815-90001-UG-Eng-revD.qxd 5/1/01 4:20 PM Page 36

Philips Medical Systems North America M3815A2 Home Blood Pressure Transmitter User Manual manual

Philips Medical Systems North America Co. Home Blood Pressure Transmitter manual

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