Arden Home Blood Pressure System

Summary

Company Confidential © 1997 Welch Allyn, Inc., printed 06/09/99 of 26

Arden Home Blood Pressure System

Sales Information Booklet

Prepared by Tom Grant

Senior Product ManagerSphygmomanometers, Stethoscopesand Laryngoscopes

Summary

of 26 © 1997 Welch Allyn, Inc., printed 06/09/99 Company Confidential

Contents1. Summary..........................................................................................................................................3

1.1. Key Message..............................................................................................................................31.2. Market .......................................................................................................................................31.3. Product......................................................................................................................................31.4. Features & Benefits ...................................................................................................................31.5. Reimbursement .........................................................................................................................3

2. Product Specifications ....................................................................................................................32.1. Technical Specifications ..........................................................................................................42.2. Device Standards ......................................................................................................................4

3. Components of the blood pressure monitor ...................................................................................53.1. Monitor......................................................................................................................................53.2. Auto-Inflate Cuff:......................................................................................................................53.3. Manual-Inflate Cuff ..................................................................................................................5

4. Price List ..........................................................................................................................................6

5. Competition......................................................................................................................................75.1. Market Share .............................................................................................................................75.2. Competitive Product Comparison Charts ................................................................................8

5.2.1. Automatic-Inflate Arm Models................................................................................................................. 85.2.2. Manual-Inflate Arm Models ..................................................................................................................... 95.2.3. Competitive Product Gallery .................................................................................................................. 10

6. Educational Material.....................................................................................................................126.1. American Society of Hypertension Releases Guidelines on Home and Ambulatory BloodPressure Monitoring ......................................................................................................................126.2. Monitoring Your Blood Pressure at Home.............................................................................136.3. Home Blood Pressure Monitoring Decreases Need For Blood Pressure Medications..........15

7. Use Instructions (abbreviated)......................................................................................................197.1. Operating the blood pressure monitor...................................................................................19

7.1.1. Inserting the batteries ............................................................................................................................. 197.1.2. Using an AC adapter (accessory)............................................................................................................ 197.1.3. Tube connection..................................................................................................................................... 20

7.2. Carrying out a measurement...................................................................................................207.2.1. Before the measurement: ........................................................................................................................ 207.2.2. Common sources of error........................................................................................................................ 207.2.3. Fitting the cuff ........................................................................................................................................ 217.2.4. Measuring procedure.............................................................................................................................. 22

7.3. Memory – displaying the last measurement..........................................................................227.4. Discontinuing a measurement................................................................................................237.5. Error messages/malfunctions .................................................................................................23

8. Product Sell Sheet .........................................................................................................................25

Summary


1. Summary

1.1. Key MessageAccurate, easy-to-use home blood pressure system featuring “fuzzy logic” smart inflation system.

1.2. Market50-million Americans living with hypertension – most over 50 years of age.

1-million home BP systems are sold through medical channels per year. An additional 2.5million systems are sold through retail channels. Some traditional med-surg distributors areselling home BP systems to physicians (family practice, cardiology, internal medicine) who willdispense, or sell, to their hypertensive patients. Identify distributors who are currently sellinghome BP to these physicians or directly to patients either through store-fronts or home-healthchannels.

1.3. ProductTwo models: Fully automatic and semi-automatic. Each model is available with either the adultcuff or large-adult cuff (cuff size is very important to accurate BP measurement). The semi-automatic model uses a manual inflation bulb and the fully automatic uses a pump. Runs on fourAA batteries (not included) or optional AC adapter. Includes D-ring cuff, instructions and vinylstorage pouch.

1.4. Features & BenefitsAs you will learn in the Competition section of this booklet, there are many home blood pressuremonitors on the market with very similar features. When someone asks what makes the Ardenunit different, point to these four key features. Most of the competitive units will not have allfour in combination.

• Simple one-button operation is easy to use. (Most competitors have several buttons andpreset switches that just complicate the procedure.)

• “Fuzzy Logic” smart inflation system is faster and more comfortable for the user.(Fuzzy logic is found on only the top-tier, most expensive automatic devices.Automatic devices without fuzzy logic will be priced about $20 less.)

• Large, easy-to-read LCD simultaneously displays systolic, diastolic and pulse (largerthan most competitors, who display systolic/diastolic together and alternate pulse).

• Patented battery drawer is easy to open. This is exclusive to the Arden (and S+K)models. Many users are elderly and may have some arthritis, so this becomes a veryuseful benefit.

1.5. ReimbursementCurrently not reimbursable under Medicare. Some private reimbursement occurs, but it is spotty.Units that are recommended or “prescribed” by a hypertension specialist are more likely to getreimbursement than those prescribed by a primary care provider.

Summary


Product Specifications

1.6. Technical Specifications

Specification Model 7052-34 Model 7052-33

Weight 465 g (with batteries) 265 g (with batteries)

Size 125 W x 155 L x 80 H (mm) 125 W x 155 L x 80 H (mm)

Storage Temperature -20° to +50° C 20° to +50° C

Humidity 15% to 85% relative humidity maximum 15% to 85% relative humidity maximum

Operation Temperature 10° to 40° C 10° to 40° C

Display Liquid Crystal Display (LCD) Liquid Crystal Display (LCD)

Character Height 20 mm 20 mm

Measuring Method Oscillometric Oscillometric

Pressure Sensor Capacitive Capacitive

Measuring Range Sys/Dia Pulse

30 to 280 mm Hg40 to 200 per minute

30 to 280 mm Hg40 to 200 per minute

Cuff Pressure DisplayRange

0 to 299 mm Hg 0 to 299 mm Hg

Memory Stores last measurement automatically Stores last measurement automatically

Measuring Resolution 1 mm Hg 1 mm Hg

Accuracy Pressure within ± 3 mm HgPulse ± 5% of reading

Pressure within ± 3 mm HgPulse ± 5% of reading

Power Source a) Four AA batteries, 1.5 vb) AC adaptor 6 v DC

a) Four AA batteries, 1.5 vb) AC adaptor 6 v DC

1.7. Device StandardsDevice corresponds to the requirements of the European standard for non-invasive bloodpressure monitors.

• EN1060-1/12:95

• EN1060-3/09:97

• DIN 58130, NIBP – clinical investigation

• ANSI/AAMI SP10, NIBP – requirements

Electromagnetic compatibility: Device fulfils the stipulations of the European standardEN 60601-1-2

Clinical testing: The clinical performance test was carried out in Germany according to the DIN58130/1997 procedure N6 (sequential).

The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have beenfulfilled.

Components of the blood pressure monitor


2. Components of the blood pressure monitor

2.1. Monitor

2.2. Auto-Inflate Cuff:

• Adult cuff for arm circumference 22-30 cm

• Large Adult cuff for arm circumference 30-38 cm

2.3. Manual-Inflate Cuff

• Adult cuff for arm circumference22-30 cm

• Large Adult cuff for armcircumference 30-38 cm

LCD

Start/Stop ButtonCuff-TubeOpening

Battery Compartment

Price List


3. Price List

Part No. Description List Discount Dealer Net

7052-33 Arden Home Blood Pressure System, Semi-Automatic, Adult $49.00 40+10 $26.46

7052-33L Arden Home Blood Pressure System, Semi-Automatic, LargeAdult

$56.00 40+10 $30.24

7052-34 Arden Home Blood Pressure System, Fully-Automatic, Adult $99.00 40+10 $53.46

7052-34L Arden Home Blood Pressure System, Fully-Automatic, LargeAdult

$106.00 40+10 $57.24

7052-35 Adult Cuff (22-30 cm) for Arden Home BP System $12.00 40+10 $6.48

7052-36 Large Adult Cuff (30-38 cm) for Arden Home BP System $15.00 40+10 $8.10

7052-37 Voltage Adapter (6v DC) for Arden Home BP System $18.00 40+10 $9.72

Competition


4. CompetitionMajor competitors include Omron, AND brand from A&D Medical, Sunbeam, Lumiscope,B-D Assure from Becton Dickinson, ADC/Conair, Private label (e.g., Walgreens, etc.).

Although Omron is the market share leader, they have not invested in new technology of late –they are mostly harvesting profits. Omron is vulnerable, especially among med-surg distributorswhere Welch Allyn enjoys good relationships. Omron sells not only home-style digital units tomed-surg, but also hand and wall aneroids, mercury columns, stethoscopes, otoscopes,ophthalmoscopes, and laryngoscopes. This Arden unit is a good opportunity to open a new frontagainst Omron and take some business that they currently get uncontested. Omron has two unitsthat incorporate fuzzy logic technology (IntelliSense). Both have smaller displays, no memory,and one has a list of $120.

The AND brand units are the most comparable to the Arden in terms of simple, one-buttonoperation, large LCD and fuzzy logic. They have two models with fuzzy logic – one has1 memory, the other has none. The model with memory uses a second button to access thememory. Neither model has the option of using an AC adapter to save battery expense. Neithermodel comes with a storage case.

B-D Assure brand from Becton Dickinson is new to the home BP market. They are a veryestablished medical products company that hopes to leverage their current relationship withdiabetics, pharmaceutical distribution channels, and physicians to become the brandprofessional’s recommend. They currently do not have a fuzzy logic unit. However, they packagea lot of value into their product offering, including a video, log book and batteries at a low price.

4.1. Market ShareOmron is by far the market share leader with 50% market share in consumer channels1 and 82%share in traditional med-surg channels2. Other competitors break out as follows in the consumerchannel:

Omron50%

AND12%

Lumiscope11%

Sunbeam10%

B-D2%

Private Label15%

1 Neilson Data, 3/27/992 HPIS Data, Full-Year 1998

Competition


4.2. Competitive Product Comparison Charts

4.2.1. Automatic-Inflate Arm Models

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ArdenHome BP System, Auto Inflate, Adult Cuff

7052-34 $99.00 2 1 Yes YesLarge (20mm), Simultaneous

S/D/P

Adult (22-30 cm)

DC 6 v, 600 mA

EN 1060-1 / -3, ANSI / AAMI SP10, DIN

58130

Soft vinyl zippered case, Instruction manual (6 lang)

Home BP System, Auto Inflate, Large-Adult Cuff

7052-34L $106.00 2 1 Yes YesLarge (20mm), Simultaneous

S/D/P

Large-Adult (30-38 cm)

DC 6 v, 600 mA

EN 1060-1 / -3, ANSI / AAMI SP10, DIN

58130

Soft vinyl zippered case, Instruction manual (6 lang)

OmronAutomatic Inflation Blood Pressure Monitor

HEM-712C $85.00 2 or 3 0 No NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned Instructions

Smart-Inflate Blood Pressure Monitor with Fuzzy Logic

HEM-711 $89.95 2 or 3 0 Yes NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned Instructions

IntelliSense™ Automatic Blood Pressure Monitor


Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned Instructions, Zippered Case

Memory, Print-out and Graph Blood Pressure Monitor

HEM-705CP $150.00 2 or 3 14 No NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned

Instructions, Built-In Printer, Zippered Case, 2 Rolls Thermal Printing Tape

Measurement Print-Out Blood Pressure Monitor

HEM-703CP $120.00 2 or 3 ? No NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned Instructions, Built-In Printer

Automatic Digital Blood Pressure Monitor

HEM-725CIC $350.00 2 or 3 350 No NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned

Instructions, Software, RS-232 Interface Cable,

Zippered Case

Automatic Inflation Monitor with Fuzzy Logic


Simultaneous S/D/P

Adult (23-33 cm)

Yes Not MentionedInstructions, Built-In Cuff

Storage

Automatic Inflation Monitor HEM-725C $120.00 2 or 3 0 No NoMedium,

Alternate S/D and P

Adult (23-33 cm)

Yes Not Mentioned Instructions, Zippered Case

Fuzzy Logic Monitor HEM-706 $160.00 2 or 3 0 Yes NoMedium,

Alternate S/D and P

Adult (23-33 cm)


Storage

Self-Storing Monitor HEM-704C $140.00 2 or 3 0 No NoMedium,

Alternate S/D and P

Adult (23-33 cm)


Storage

AND (A&D Medical)

One Step Auto-Inflation UA-767 $89.95 2 0 No NoLarge (16mm), Simultaneous

S/D/P

Adult (19-31 cm)

Not Available

AAMI SP10 Instructions

MedCheck Kit UA-767MC $139.95 2 0 No NoLarge (16mm), Simultaneous

S/D/P

Adult (19-31 cm)

Not Available

AAMI SP10

Instructions, Record Keeping Software, 12-Min. Video, 334-Page Book, BP

Log, Zippered Case

Fuzzy Logic Auto-Inflation UA-779 $99.95 2 1 Yes YesLarge (16mm), Simultaneous

S/D/P

Adult (19-31 cm)

Not Available


Fuzzy Logic Auto-Inflation UA-777 $99.95 2 0 Yes YesLarge (16mm), Simultaneous

S/D/P

Adult (19-31 cm)

Not Available


Auto-inflation monitor w/printer UA-751 $179.95 2 14 No NoMedium,

Alternate S/D and P

Adult (19-31 cm)

Yes AAMI SP10Instructions, Hard-Vinyl

Case, Built-In Printer

Classic Blood Pressure Monitor, Auto-Inflation, Jumbo Display

UA-731 $89.95 2 ? No NoMedium,

Alternate S/D and P

Adult (19-31 cm)

Not Available

AAMI SP10Instructions, Hard-Vinyl

Case

Competition


Automatic-Inflate Arm Models (continued)

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Lumiscope

Fuzzy Logic Blood Pressure Monitor 1087 $99.00 1 1 Yes YesMedium,

Alternate S/D and P

Adult ? Not Mentioned Instructions

Auto-inflating Blood Pressure Monitor 1085 $80.00 1 1 No NoMedium,

Alternate S/D and P

Adult ? Not Mentioned Instructions

B-D Assure

Blood Pressure Monitor, Auto Inflate A20 $70.00 5 7 No NoLarge (19mm), Alternate S/D

and P

Adult (22-32 cm)

Yes Not MentionedInstructions, Video, Log

Book, Batteries

Blood Pressure Monitor, Deluxe Automatic with Cuff Storage

A30 $85.00 5 7 No NoLarge (19mm), Alternate S/D

and P

Adult (22-32 cm)

Yes Not Mentioned

Instructions, Video, Log Book, AC Adaptor, Built-In

Cuff Storage, Batteries

Sunbeam

Auto Inflate Blood Pressure Monitor 7654 $95.00 1 1 Yes YesLarge (16mm), Simultaneous

S/D/PAdult Yes Not Mentioned Instructions

4.2.2. Manual-Inflate Arm Models

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Arden

Home BP System, Manual Inflate, Adult Cuff 7052-33 $49.00 2 1 Large (20mm), Simultaneous S/D/P Adult (22-30 cm)EN 1060-1 / -3, ANSI / AAMI

SP10, DIN 58130

Home BP System, Manual Inflate, Large-Adult Cuff 7052-33L $56.00 2 1 Large (20mm), Simultaneous S/D/P Adult (30-38 cm)EN 1060-1 / -3, ANSI / AAMI

SP10, DIN 58130

OmronManual Inflation Blood Pressure Monitor HEM-412C $55.00 2 or 3 0 Medium, Alternate S/D and P Adult (23-33 cm) Not Mentioned

Manual Inflation Monitor HEM-425C $80.00 2 or 3 0 Medium, Alternate S/D and P Adult (23-33 cm) Not Mentioned

AND (A&D Medical)Manual Inflation UA-702 $51.95 2 0 Medium, Alternate S/D and P Adult (19-31 cm) AAMI SP10

Classic Blood Pressure Monitor, Manual Inflation, Jumbo Display

UA-711 $59.95 2 0 Medium, Alternate S/D and P Adult (19-31 cm) AAMI SP10

Lumiscope

Digital Electronic Blood Pressure & Pulse Monitor 1060 $40.00 1 1 Small, Alternate S/D and P Adult Not Mentioned

Digital Electronic Blood Pressure & Pulse Monitor 1067 $40.00 1 1 Medium, Alternate S/D and P Adult Not Mentioned

B-D Assure

Blood Pressure Monitor, Manual Inflate A10 $40.00 5 1 Medium (14.5), Alternate S/D and P Adult (22-32 cm) Not Mentioned

SunbeamManual Inflate Blood Pressure Monitor 7622 $49.00 1 1 Large (16mm), Simultaneous S/D/P Adult Not Mentioned

Competition


4.2.3. Competitive Product Gallery

Omron Automatic Inflate

HEM703CP HEM704C HEM705CP HEM706

HEM707 HEM712C HEM711 HEM737

Omron Manual Inflate

HEM412C HEM425C

AND Automatic Inflate

UA731 UA751 UA767 UA779

Competition


AND Manual Inflate

UA702 UA711

Lumiscope Automatic and Manual Inflate

1085 1087 1060 1067

B-D Assure Automatic and Manual Inflate

A20 A30 A10

Sunbeam Automatic and Manual Inflate

7654 7622

Educational Material


5. Educational Material

5.1. American Society of Hypertension Releases Guidelines on Home and Ambulatory BloodPressure Monitoring

Special Medical Reports:

American Society of Hypertension Releases Guidelines on Home andAmbulatory Blood Pressure MonitoringBlood pressure readings taken outside a clinic setting (supplemental blood pressure readings) by a patient orsomeone else or by ambulatory monitoring devices have become increasingly prominent in the management ofpatients with hypertension. A panel of experts convened by the American Society of Hypertension has publishedthe first guidelines on the use of home (self) and ambulatory blood pressure monitoring. The guidelines wereundertaken because of a concern by physicians regarding the proper role of home and ambulatory monitoringdevices in the management of hypertensive patients. The panel reviewed relevant research and formulatedrecommendations.

The guidelines include discussions on the background of ambulatory blood pressure monitoring, clinical indicationsfor ambulatory monitoring, the testing and validation of monitors for ambulatory monitoring, the background ofhome (self) blood pressure monitoring, clinical indications for self-monitoring, and the testing and validation ofmonitors for home use. The following information has been excerpted from the section on self-monitoring of bloodpressure.

Self-monitoring can be an accurate method to evaluate a patient's usual blood pressure and to evaluate the effect ofanti-hypertensive medication. Self-measured blood pressure readings may be more reliable because of the greaternumber of readings that can be obtained during a certain period.

In patients with hypertension, the blood pressure readings taken in a clinic setting tend to be higher. Thisdiscrepancy in patients with mild hypertension is typically in the range of 5 to 10 mm Hg.

The circumstances at the time of measurement may influence the height of the blood pressure. The time of day isimportant, although studies in individuals who have not been treated for hypertension have not necessarily shownlarge differences. If readings are taken too soon after a meal or exercise, they may be lower than at other times,while if they are taken after smoking a cigarette or drinking coffee, they may be increased.

The use of self-monitoring is recommended for the majority of patients with hypertension. Exceptions wouldinclude persons who are markedly obese or those with irregular heart rhythms. Four potential benefits of homemonitoring were noted by the panel:

• Distinguishing sustained hypertension from white coat hypertension

• Assessment of the response to anti-hypertensive medications

• Improved patient compliance

• A possible reduction in costs

The choice of monitor should be either a validated electronic device or an aneroid monitor. Mercurysphygmomanometers, while still the gold standard for clinical use, are not generally recommended for home use. Ofthe different types of monitors available for home use, the panel recommends an aneroid sphygmomanometer asfirst choice. Such devices are reasonably accurate and can be checked easily by connecting the gauge to a mercurycolumn with a connector. Aneroid monitors are also the least expensive. However, these devices require a certaindegree of manual dexterity and hearing acuity. Younger patients should not have any problems using them, but



they may cause problems for elderly patients. For patients who cannot use an aneroid recorder, one of theelectronic devices may be preferable.

Patients should check their new blood pressure monitoring devices in their physician's office before home use andthen once a year thereafter to ensure accuracy.

The panel recommends that patients be instructed to take readings both in the morning and the evening, on workand non-work days. The frequency of readings should be determined by the patient's clinical situation. In newlydiagnosed patients, or patients in whom anti-hypertensive medication has recently been initiated or changed, itmay be appropriate to take readings several days per week, while in patients whose condition is diagnosed andstable, readings need to be taken less frequently. There is no universally agreed on upper limit of normal homeblood pressure level, but a reasonable figure would be 135/85 mm Hg. Blood pressure recorded at work may besomewhat higher.

The panel believes that patients should be reimbursed by their insurance companies for home blood pressuremonitors. At present, neither Medicare nor Medicaid does this. Current costs range from $30 to $150.

The complete guidelines appear in the January 1996 issue of the American Journal of Hypertension.

Copyright 1996, American Academy of Family Physicians

This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known orlater invented, except as authorized in writing by the AAFP.

http://www.aafp.org/afp/091596/special.html This Web page was last modified on May 07, 1999.

5.2. Monitoring Your Blood Pressure at Home

Monitoring Your Blood Pressure at HomeWhy should I measure my blood pressure at home and keep a record of it?

Measuring your blood pressure at home and keeping a record of the different measurements will show you andyour doctor how much your blood pressure changes during the day. Your doctor can use your measurements to seehow your blood pressure medicine is working.

What equipment do I need to measure my blood pressure?

To measure your blood pressure at home, you can use either an aneroid monitor or a digital monitor. The aneroiddevice has a dial gauge that is read by looking at a pointer. The cuff is inflated by hand by squeezing a rubber bulb.Digital monitors have either manual or automatic cuffs. The blood pressure reading flashes on a small screen.Choose the type of monitor that best suits your needs.

What are the advantages and disadvantages of the aneroid monitor?

One advantage of this monitor is that it can easily be carried from one place to another. Also, the cuff for the devicehas a built-in stethoscope, so you don't need to buy a separate stethoscope. It's also easier to manage this way. Theunit may have a special feature that makes it easier to put the cuff on with one hand. In addition, the aneroidmonitor costs less than digital monitors. Aneroid monitors range in price from about $20 to $30.

The aneroid monitor also has some disadvantages. First, it is a complicated device that can easily be damaged andlose accuracy. The device is also difficult to use if it doesn't have the special feature -- a metal ring -- that makes iteasier to put the cuff on. In addition, the rubber bulb that inflates the cuff may be difficult to squeeze. This monitormay not be appropriate for hearing-impaired people, because of the need to listen to heart sounds through thestethoscope.

What are the advantages and disadvantages of the digital monitor?



Since the digital monitor is automatic, it is the most popular blood-pressure measuring device. The blood pressureis easy to read, because the numbers are shown on a screen. Some electronic monitors have a paper printout thatgives a record of the blood pressure reading.

The digital monitor is easier to use than the aneroid unit. It has a gauge and stethoscope that are one unit, and thenumbers are easy to read on the display area. The device also has an error indicator. Furthermore, deflation isautomatic. Inflation of the cuff is either automatic or manual, depending on the model. This blood pressuremonitoring device is good for hearing-impaired patients, since there is no need to listen to heart sounds through thestethoscope.

A disadvantage of the digital monitor is that the accuracy is changed by body movements or an irregular heartrate. In addition, the monitor requires batteries. Some models are designed for use with the left arm only. This maymake them hard for some patients to use. Finally, some digital monitors are expensive. They start in price at $40for semiautomatic models. Fully automatic models start at $100.

Can I use a finger/wrist blood pressure monitor?

Tests have shown that finger/wrist devices do not measure the blood pressure very accurately. They are extremelysensitive to position and body temperature.

What features should I look for in a blood pressure monitor?

• Proper cuff size is very important. Ask a medical professional to tell you the cuff size you need, based onthe size of your arm. Blood pressure readings will be wrong if your cuff is the wrong size.

• The numbers on the monitor must be easy to read.

• If you are using a stethoscope, you must be able to hear heart sounds through it.

• Cost may be an important factor. Since home blood pressure units vary in price, you may have to shoparound. The most expensive units might not be the best or the most accurate.

How do I know if my monitoring device is accurate or if I am using it correctly?

Once you buy your monitor, take it to your doctor's office to be checked for accuracy. You should have your monitorchecked once every year. Proper care and storage are also necessary. Make sure the tubing is not twisted when themonitor is stored, and keep it away from heat. Periodically check the tubing for cracks and leaks.

Ask your doctor or nurse to teach you how to use your blood pressure monitor correctly. Proper use of it will helpyou and your doctor achieve good results in controlling your blood pressure.

In measuring my blood pressure, what do I need to understand?

First, you need to know the meaning of a few terms. Blood pressure is the force of blood against the walls of theartery. You may be asked to monitor your blood pressure at home because your office readings show that you havehypertension, or high blood pressure. Remember, your blood pressure changes during the day, according to theneeds of your body. For example, blood pressure goes up when you exercise and goes down when you are resting orsleeping.

You will be measuring the blood pressure in your brachial artery, a blood vessel that goes from your shoulder tojust below your elbow. The blood pressure monitor will show two different pressure readings. The systolic pressureis the highest pressure in an artery when your heart is pumping blood to your body. The diastolic pressure is thelowest pressure in an artery when your heart is at rest.

What do I need to do before I measure my blood pressure?

• Rest for three to five minutes before measuring your blood pressure. Do not talk.

• Sit in a comfortable position, with your legs and ankles uncrossed and your back supported.

• Place your arm, raised to the level of your heart, on a table or a desk, and sit still.

• Wrap the correctly sized cuff smoothly and snugly around the upper part of your bare arm. The cuffshould fit snugly, but there should be enough room for you to slip one fingertip under the cuff.

• Be certain that the bottom edge of the cuff is 1 inch above the crease of your elbow.

If I use an aneroid monitor, how do I measure and record my blood pressure?



1. Put the stethoscope ear pieces into your ears, with the ear pieces facing forward.

2. Place the stethoscope disk on the inner side of the crease of your elbow.

3. Rapidly inflate the cuff by squeezing the rubber bulb to 30 to 40 points higher than your last systolicreading. Inflate the cuff rapidly, not just a little at a time. Inflating the cuff too slowly will cause a falsereading.

4. Slightly loosen the valve and slowly let some air out of the cuff. Deflate the cuff by 2 to 3 millimetersper second. If you loosen the valve too much, you won't be able to determine your blood pressure.

5. As you let the air out of the cuff, you will begin to hear your heartbeat. Listen carefully for the firstsound. Check the blood pressure reading by looking at the pointer on the dial. This number will be yoursystolic pressure.

6. Continue to deflate the cuff. Listen to your heartbeat. You will hear your heartbeat stop at some point.Check the reading on the dial. This number is your diastolic pressure.

7. Write down your blood pressure, putting the systolic pressure before the diastolic pressure. You wouldwrite down a number such as 120/80.

8. If you want to repeat the measurement, wait two or three minutes before re-inflating the cuff.

If I use a digital monitor, how do I measure and record my blood pressure?

1. Put the cuff around the arm. Turn the power on, and start the machine.

2. The cuff will inflate by itself with a push of a button on the automatic models. On the semiautomaticmodels, the cuff is inflated by squeezing the rubber bulb. After the cuff is inflated, the automaticmechanism will slowly reduce the cuff pressure.

3. Look at the display window to see your blood pressure reading. The machine will show your systolic anddiastolic blood pressures on the screen. Write down your blood pressure, putting the systolic pressurebefore the diastolic pressure.

4. Press the exhaust button to release all of the air from the cuff.

5. Remove the cuff. If you want to repeat the measurement, wait two or three minutes before re-inflatingthe cuff. Otherwise, remove the cuff and turn off the machine.

This information provides a general overview on home blood pressure monitoring equipment and technique and may not apply to everyone. Talk to your family doctorto find out if this information applies to you and to get more information on the subject.

This handout is provided to you by your family physician and the American Academy of Family Physicians. [8/96]

http://www.aafp.org/afp/080196/pat-545.html This Web page was last modified on January 10, 1997.

Permission is granted to reproduce this material for nonprofit educational purposes. Written permission is required for other uses, including electronic uses.

5.3. Home Blood Pressure Monitoring Decreases Need For Blood Pressure Medications

HOME BLOOD PRESSURE MONITORING DECREASESNEED FOR BLOOD PRESSURE MEDICATIONSCost not reducedCHICAGO—Conventional blood pressure readings taken in a physician's office tend to be higherthan normal, possibly leading physicians to over prescribe blood pressure medications,according to an article in the October 1 issue of The Journal of the American Medical Association(JAMA).



Jan A. Staessen, M.D., Ph.D., from the Katholieke Universiteit Leuven, in Belgium, andcolleagues studied 419 hypertensive patients at 56 centers in Europe to compare hypertensiontreatment based on conventional office blood pressure readings versus daytime ambulatory bloodpressure readings, which are taken by a monitor over a whole day as patients engage in theirnormal activities.

The researchers found that after about six months, more ambulatory blood pressure thanconventional blood pressure patients had stopped antihypertensive drug treatment (26.3 percentvs. 7.3 percent), and fewer ambulatory blood pressure patients had progressed to sustainedmultiple-drug treatment.

They write: "By using ambulatory blood pressure monitoring, antihypertensive drug treatmentmay be postponed in 25 percent of the hypertensive population and multiple blood pressuredrug treatment avoided in 15 percent."

The authors report that ambulatory blood pressure monitoring could save up to 20 percent of thelong-term health care costs spent treating hypertension. Unfortunately, this savings would beoffset by the costs associated with ambulatory blood pressure monitoring. The equipment iscostly making it impractical for wide scale implementation.

The authors recommend that three factors be considered when advising on clinical application:(1) the cost-effectiveness in terms of prevention of cardiovascular complications; (2) alleviatingunnecessary stress for hypertensive patients being monitored in a physician's office; (3) theamount of clinical training necessary to implement the technique.

The researchers conclude: "The present findings suggest the adjustment of antihypertensivetreatment based on ambulatory blood pressure monitoring instead of conventional [monitoring]may lead to less intensive drug treatment with preservation of blood pressure control, generalwell-being and inhibition of left ventricular enlargement. On the other hand, ambulatory bloodpressure monitoring, at the presently applied rates, does not seem to reduce the short-term costsof antihypertensive treatment. Whether these conclusions would still hold true in the long term,especially after accounting for morbidity and mortality, remains to be elucidated."Error! Bookmark not defined.

Editorial: A New Role for Ambulatory Blood Pressure Monitoring

In an accompanying editorial in the October 1 issue of JAMA, Thomas G. Pickering, M.D.,D.Phil., of the New York Hospital-Cornell Medical Center, N.Y., writes: "...basing treatments onambulatory blood pressure records would be prohibitively expensive. It would also beinconvenient for the patients, since each recording involves two visits to the clinic, one to havethe monitor put on and the other to have it disconnected."

He continues: "An alternative procedure would be to use self-monitoring for dose titration. Thereare now reliable and inexpensive electronic monitors that are easy to use and can either store orprint out the blood pressure readings. In principle, transmission of the readings to the physiciancan be achieved without the need for an office visit. An increasing number of studies havedocumented the value of self-monitoring for assessing the efficacy of drug treatment, andalthough, like ambulatory monitoring, its use is not yet generally reimbursed, it has the potentialof cost savings as well as improving the quality of treatment. Whether home or ambulatorymonitoring becomes the method of choice for assessing antihypertensive treatment, theAmbulatory Blood Pressure Monitoring and Treatment of Hypertension study is an importantstep forward in unseating the supremacy of physicians' office blood pressure measurements."(JAMA. 1997;278:1110)



Note: The study was funded by ZENECA Inc. The study medication was donated by ZENECAand Roerig-Pfizer.

Abstracts - October 1, 1997

Antihypertensive Treatment Based on Conventional orAmbulatory Blood Pressure Measurement

A Randomized Controlled Trial

Jan A. Staessen, MD, PhD; Geert Byttebier, MSc; Frank Buntinx, MD, PhD; Hilde Celis, MD; EoinT. O'Brien, MD, FRCP; Robert Fagard, MD, PhD; Ambulatory Blood Pressure Monitoring andTreatment of Hypertension Investigators

Context.—Ambulatory blood pressure (ABP) monitoring is used increasingly in clinical practice,but how it affects treatment of blood pressure has not been determined.

Objective.—To compare conventional blood pressure (CBP) measurement and ABP measurementin the management of hypertensive patients.

Design.—Multicenter, randomized, parallel-group trial.

Setting.—Family practices and outpatient clinics at regional and university hospitals.

Participants.—A total of 419 patients (>/=18 years), whose untreated diastolic blood pressure(DBP) on CBP measurement averaged 95 mm Hg or higher, randomized to CBP or ABP arms.

Interventions.—Antihypertensive drug treatment was adjusted in a stepwise fashion based oneither the average daytime (from 10 AM to 8 PM) ambulatory DBP (n=213) or the average of 3sitting DBP readings (n=206). If the DBP guiding treatment was above (>89 mm Hg), at (80-89 mmHg), or below (<80 mm Hg) target, 1 physician blinded to the patients' randomization intensifiedantihypertensive treatment, left it unchanged, or reduced it, respectively.

Main Outcome Measures.—The CBP and ABP levels, intensity of drug treatment,electrocardiographic and echocardiographic left ventricular mass, symptoms reported byquestionnaire, and cost.

Results.—At the end of the study (median follow-up, 182 days; 5th to 95th percentile interval,85-258 days), more ABP than CBP patients had stopped antihypertensive drug treatment (26.3%vs 7.3%;P <.001), and fewer ABP patients had progressed to sustained multiple-drug treatment(27.2% vs 42.7%; P<.001). The final CBP and 24-hour ABP averaged 144.1/89.9 mm Hg and129.4/79.5 mm Hg in the ABP group and 140.3/89.6 mm Hg and 128.0/79.1 mm Hg in the CBPgroup. Left ventricular mass and reported symptoms were similar in the 2 groups. The potentialsavings in the ABP group in terms of less intensive drug treatment and fewer physician visitswere offset by the costs of ABP monitoring.

Conclusions.—Adjustment of antihypertensive treatment based on ABP monitoring instead ofCBP measurement led to less intensive drug treatment with preservation of blood pressurecontrol, general well-being, and inhibition of left ventricular enlargement but did not reduce theoverall costs of antihypertensive treatment.



JAMA. 1997;278:1065-1072

From the Hypertensie en Cardiovasculaire Revalidatie Eenheid, Departement voor Moleculair enCardiovasculair Onderzoek, Katholieke Universiteit Leuven (Drs Staessen, Celis, and Fagard),and Academisch Centrum voor Huisartsgeneeskunde, Katholieke Universiteit Leuven (DrBuntinx), Leuven, Belgium; Hypertension Unit, Beaumont Hospital, Dublin, Ireland (Dr O'Brien);and ZENECA NV, Destelbergen, Belgium (Dr Byttebier). A complete list of participants in theAmbulatory Blood Pressure Monitoring and Treatment of Hypertension group appears at the endof the article.

EDITOR'S NOTE.—Measuring blood pressure (BP) is a standard part of the physical examination,but whether BP measurement in the physician's office is the best measure for guiding decisionsregarding treatment of hypertension is unknown. These authors enrolled patients and randomlyallocated decisions regarding hypertension treatment to either clinic BP measurement orambulatory BP measurement. Fewer patients whose BP was treated based on ambulatorymeasures received antihypertensive drug treatment and those who were treated tended to receivefewer drugs, with no increase in left ventricular mass. In an accompanying editorial (p 1110),Thomas Pickering, MD, suggests that ambulatory BP measurement (or, more likely because oflower cost, home BP measurement) has the potential to reduce costs and improve quality ofhypertension treatment, particularly for patients with white coat hypertension.

Margaret A. Winker, MD, Senior Editor

Use Instructions (abbreviated)


6. Use Instructions (abbreviated)

6.1. Operating the blood pressure monitor

6.1.1. Inserting the batteries

a) Open cover as illustrated.

b) Insert the batteries (4 AA, 1.5v),observing the correct polarity.

Attention!

• If the battery warning symbol appears(as shown in the diagram at left), themonitor is unusable until the batterieshave been replaced.

• Use AA long-life or alkaline 1.5vbatteries. The use of rechargeablebatteries is not recommended.

• If the blood pressure monitor is leftunused for long periods, remove thebatteries from the device.

Functional check: Hold down theStart/Stop button to test all the displayelements. When functioning correctly allsegments will appear.

6.1.2. Using an AC adapter (accessory)

1. Push the power plug into the socket at theback of the monitor.

2. Plug the voltage adapter into a 110v powersocket. Test that power is available bypressing the Start/Stop button.

Note:

• No power is taken from the batteries whilethe adapter is connected to the instrument.

• If the voltage is interrupted during themeasurement (e.g., by removing theadapter), the instrument must be reset byremoving the plug and replacing it.

BatteryWarning

Symbol

+

_ + +

+_ _

_



6.1.3. Tube connection

Insert the cuff tube into the opening providedon the left side of the instrument, as shown inthe diagram.

6.2. Carrying out a measurement

6.2.1. Before the measurement:

• Avoid eating, smoking, and all forms of exertion directly before performing the measurement.All these factors influence the measurement results. Relax by sitting in an armchair in a quietatmosphere for about 10 minutes before the measurement.

• Remove any garment that fits closely to your upper arm.

• Always measure on the same arm (preferably left).

• Attempt to carry out the measurements regularly at the same time of day, since blood pressurechanges during the course of the day.

6.2.2. Common sources of error

Note: Comparable blood pressure measurements always require the same conditions. Theseshould be quiet conditions.

Cuffs that are too narrow or too short result in false measurement values. Selecting the correctcuff is very important. The cuff size is dependent upon the circumference of the arm (measuredmidway between the armpit and elbow). The permissible range is 22-to-30 cm for the Adult cuffand 30-to-38 cm for the Large Adult cuff. The use of a cuff that is too small will result in anartificially high reading.

• All efforts by the patient to support the arm can increase the blood pressure. Make sure youare in a comfortable, relaxed position and do not activate any of the muscles in the arm beingmeasured during the procedure. Use a cushion for support if necessary.

• If the arm artery lies considerably lower or higher than the heart, an erroneous blood pressurewill be measured. (Each 15 cm difference in height results in an error of 10 mm Hg.)

Note: Only use clinically approved original cuffs.

• A loose cuff or a sideways protruding air pocket causes false measurement values.

• With repeated measurements, blood accumulates in the tested arm, which can lead to falseresults. Correctly executed blood pressure measurements, therefore, should be repeated atleast 30 seconds after previous attempts.



6.2.3. Fitting the cuff

1. Pass the end of the cuff (with sewn-in rubber stopper)through the metal stirrup so a loop is formed. The Velcroclosure must be facing outward. (Ignore this step if thecuff has already been prepared.)

2. Push the cuff over the left upper arm so the tube pointsin the direction of the lower arm.

TAB RUBBER TUBE

2-3 cm

3. Lay the cuff on the arm as illustrated at left. It isimportant that the tube coming out of the cuff lies overthe brachial artery, located just to the inside of thebicep. Make certain that the lower edge of the cuff liesapproximately 2 to 3 cm above the elbow and that therubber tube leaves the cuff on the inner side of the arm.

4. Tighten the free end of the cuff and close the cuff withthe Velcro closure.

5. There must be no free space between the arm and thecuff. Clothing must not restrict the arm. Any piece ofclothing that does must be taken off.

6. Secure the cuff with the Velcro closure in such a waythat it lies comfortably and is not too tight. Lay the armon the table (palm upward) so the cuff is at the sameheight as the heart. Make sure the tube is not kinked.

7. Remain seated quietly for two minutes before you beginthe measurement.

Note: If it is not possible to fit the cuff to the left arm, it canbe placed on the right one. However, all measurementsshould be made using the same arm.

2-3cm



6.2.4. Measuring procedure

1. Press the Start/Stop button. The pump begins to inflate the cuff.The rising pressure in the cuff is shown on the display.

2. After the suitable inflation pressure has been reached, the pumpstops and the pressure gradually falls. The cuff pressures aredisplayed.

3. When the instrument detects a pulse, the heart symbol in thedisplay starts to flash and a beep sounds for every heart beat.

4. A longer beep is sounded when the measurement has beencompleted. The systolic, diastolic blood pressures, and pulserate now appear in the display.

5. The results of the measurement remain on the display until youturn off the instrument. If no button is pressed for a period offive minutes, the instrument turns itself off to preserve thebatteries.

6.3. Memory – displaying the last measurementThe measured results are stored in the instrumentuntil a new measurement is carried out or thebatteries are removed.You can recall the stored values at any timeby pressing the Start/Stop buttonfor at least three seconds.



6.4. Discontinuing a measurementIf it is necessary to interrupt a blood pressuremeasurement for any reason (e.g., the patient feelsill), the Start/Stop button can be pressed at anytime. The instrument immediately reduces the cuffpressure.

6.5. Error messages/malfunctionsIf an error occurs during a measurement, the measurement will bediscontinued and a corresponding error code will be displayed.

Error No. Possible cause(s)

Er 1 The systolic pressure was determined but afterwards the cuffpressure fell below 20 mm Hg.

• This situation can occur if the tube becomes unplugged afterthe systolic blood pressure has been measured.

• Further possible cause: No pulse could be detected.

Er 2 Unnatural pressure impulses impair the result of themeasurement.

• Cause: The arm was moved during the measurement(artefact).

Er 3 Inflation of the cuff takes too long.

• The cuff is not correctly seated or the hose connection isnot sealed.



Other possible malfunctions and their remedies:

If problems occur when using the device, the following points should be checked and ifnecessary, the corresponding measures are to be taken:

Malfunction Remedy

The display remains blankwhen the instrument isswitched on, although thebatteries are in place.

• Check whether the batteries are installed with the correctpolarity, then correct if necessary.

• If the display remains blank, remove the batteries, then replacethem, or exchange them for new ones.

The pressure does not risealthough the bulb is beingsqueezed.

• Check the connection of the cuff tube and connect it properly ifnecessary.

The device frequently failsto measure the bloodpressure values, or thevalues measured are toolow or too high.

• Fit the cuff correctly on the arm.

• Before starting the measurement, make sure the cuff is not fittedtoo tightly and that there is no rolled-up sleeve exerting pressureon the arm above the measuring position. Take off articles ofclothing if necessary.

• Measure the blood pressure again in complete silence.

Every measurement resultsin different values,although the devicefunctions normally andnormal values aredisplayed.

• Read the following information and the points listed under“Common sources of error.” Repeat the measurement.

The blood pressure valuesmeasured differ form thosemeasured by the doctor.

• Record the daily development of the values and consult yourdoctor about them.

After the instrument hasinflated the cuff thepressure falls very slowlyor not at all (no reasonablemeasurement possible).

• Missing plastic ring (distance piece) at tube connection. This mayonly be removed for servicing reasons. Push this ring over the tubeconnector so it fits properly and repeat the measurement.

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Product Sell Sheet


Arden Home Blood Pressure System

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