ADC 6012 Instruction Manual

Digital

Blood Pressure

Monitor

Semi-Automatic Blood Pressure Monitor

6012

Instruction Manual

PLEASE NOTE:

THIS MEDICAL INSTRUMENT MUST BE

USED ACCORDING TO INSTRUCTIONS

TO ENSURE ACCURATE READINGS.

Questions?

Call ADC toll free at 1-800-232-2670

6012 Semi-Automatic Blood Pressure Monitor

Table of Contents

1. Introduction

2. Warnings and Cautions

3. About Blood Pressure

3.1 What is Blood Pressure?

3.2 What is a Normal Blood Pressure?

3.3 What Influences Blood Pressure?

3.4 Does Blood Pressure Vary?

3.5 What is Hypertension?

3.6 Can Hypertension be Controlled?

3.7 Why Measure Blood Pressure at Home?

3.8 How is Blood Pressure Measured?

3.9 How Should I Record My Blood Pressure?

4. Components of Your Blood Pressure Monitor

5. Setting Up Your Blood Pressure Monitor

5.1. Inserting the Batteries

5.2. Tube Connection

6. Taking a Measurement

6.1. Before Measuring

6.2. Common Sources of Error

6.3. Fitting the Cuff

6.4. Measuring Procedure

6.5. Inflating Further

6.6. Discontinuing a Measurement

6.7. Memory – Displaying the Last Measurement

7. Error Messages/Troubleshooting

8. Care and Maintenance

9. Warranty

10. Quality Standards

11. Technical Specifications

12. Accessories

13. How to Contact Us

1. INTRODUCTION

1. Introduction tor.

Congratulations on your purchase of the Semi-Automatic ADC ® ADvantage TM Blood Pressure Moni-

In hospitals and physician's offices throughout the world, where accuracy and dependability are critical, ADC ® professional diagnostic products are the instruments of choice.

Now, you too can enjoy the benefits of ADC ® engineering and quality in the home. This feature rich instrument was designed to simplify the measurement of blood pressure and pulse rate at home and deliver consistent, dependable results.

Your ADC ® ADvantage TM blood pressure monitor is a semi-automatic digital blood pressure measuring device for use on the upper arm. It enables very fast and reliable measurement of the systolic and diastolic blood pressure as well as the pulse by way of the oscillometric method. This device offers clinically proven accuracy and has been designed to be user friendly.

Read this booklet thoroughly before attempting to use your new ADC ® ADvantage TM Digital Blood

Pressure Monitor.

Remember…

• Only a health care professional is qualified to interpret blood pressure measurements. This device is

NOT intended to replace regular medical checkups.

•It is recommended that your physician review your procedure for using this device.

•Blood pressure readings obtained by this device should be verified before prescribing or making adjustments to any medications used to control hypertension. Under no circumstances should YOU alterthe dosages of any drugs prescribed by your doctor.

• This monitor is intended for use by adults only. Consult with a physician before using this instrument on a child.

•In cases of irregular heartbeat (Arrhythmia), measurements made with this instrument should only be evaluated after consultation with your doctor.

•Familiarize yourself with the section titled "About Blood Pressure". It contains important information on the dynamics of blood pressure readings and will help you to obtain the best results.

NOTE!

This device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens) during use. These can lead to erratic results. Do not attempt to service or repair this device yourself. Should a malfunction occur, refer to the back of this booklet for service information.

2. WARNINGS and PRECAUTIONS

!

Warning: The device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g., mobile telephones, microwave ovens). These can lead to temporary impairment of the measuriong accuracy.

Warning: Use of this instrument on patients under dialysis therapy or on anticoagulant, antiplatelets, or steroids could cause internal bleeding.

Warning: Do not use cuffs, AC adapters or batteries other than those included with thisproduct or replacement parts supplied by the manufacturer.

Warning: This system may fail to yield specified measurement accuracy if operated or stored in temperature or humidity conditions outside the limits stated in the specifications section of this manual.

Warning: This Product May Contain A Chemical Known To The State of California To Cause Cancer, Birth

Defects, Or Other Reproductive Harm.

Caution: To avoid any possibility of accidental strangulation, keep this unit away from children and do not drape tubing around your neck.

Caution: The standard material used for the bladder and tubing is latex-free.

Attention: Self-measurement means control, not diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circumstances should you alter the dosages of any drugs prescribed by your doctor.

Attention: The pulse display is not suitable for checking the frequency of heart pacemakers!

Attention: In cases of irregular heartbeat, measurements made with this instrument should only be evaluated after consultation with your doctor.

NOTE: To obtain the greatest accuracy from your blood pressure instrument, it is recommended that the instrument be used within a temperature range of 50°F (10°C) to 104°F (40°C), with a relative humidity range of 15-90% (non-condensing).

3. ABOUT BLOOD PRESSURE

3.1. What is Blood Pressure?

Simply put, arterial blood pressure is the force of blood exerted against the walls of the arteries.

There are two components to blood pressure - systolic and diastolic pressure. Systolic, the higher pressure, occurs during contraction of the heart. Diastolic, the lower pressure, occurs when the heart is at "rest."

Your level of blood pressure is determined in the circulatory center of the brain and adjusts to a variety of situations through feedback from the nervous system. To adjust blood pressure, the strength and frequency of the heart (Pulse), as well as the width of circulatory blood vessels is altered. Blood vessel width is effected by fine muscles in the blood vessel walls.

Blood pressure is traditionally measured in millimeters of mercury (mmHg). It is recorded as systolic/diastolic. For example, a systolic of 120 and diastolic of 80 would be recorded 120/80.

Blood pressure is a dynamic vital sign - one that changes constantly and throughout the day. A person's "resting" blood pressure is the pressure that exists first thing in the morning while a person is still at rest and before consumption of food or drink.

3.2 What is a Normal Blood Pressure?

A systolic pressure of less than 120mmHg and a diastolic pressure of under 80mmHg are recognized as normal by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High

Blood Pressure, 2003.

Note: Blood pressure does increase with age, so you must check with your doctor to find out what is

"normal" for you! Even with normal blood pressure values, a regular self-check with your blood pressure monitor is recommended. You can detect possible changes in your values early and react appropriately.

If you are under-going medical treatment to control your blood pressure, keep a record of values along with time of day and date. Show these values to your doctor. Never use the results of your measurements to independently alter the drug doses prescribed by your doctor.

3.3 What Influences Blood Pressure?

Blood pressure is influenced by many factors including age, weight, physical conditioning, past illness, time of day, altitude, activity, and climate, to name just a few. In general, blood pressure is lower in the morning and increases throughout the day. It is lower in warm weather, and higher in cold weather.

Physical activity can have a significant short term impact on blood pressure. Work, exercise, smoking, eating, drinking - even talking, laughing, or crying will all affect a person's blood pressure.

Your diet, including beverages containing caffeine or alcohol, may affect blood pressure.

Emotional stress can have a dramatic impact on your blood pressure.

Even repeated blood pressure measurements taken without adequate rest between readings will alter your blood pressure as the vessels in your arm engorge with blood. Many of these influences are only temporary or short term, though chronic (long term) exposure to some factors may result in permanently elevated blood pressure levels.

3.4 Does Blood Pressure Vary?

Constantly. An individual's blood pressure varies greatly on a daily and seasonal basis. It changes throughout one's lifetime. It is not uncommon for systolic pressure to vary by 40mmHg or more throughout the course of a single day! While generally not as volatile, diastolic pressure can still vary significantly. In hypertensive individuals, variations are even more pronounced. Normally, blood pressure is at its lowest during sleep and rises in the morning and throughout the day. The chart (right) illustrates the fluctuations that could occur in a typical day.

3.5 What is Hypertension?

Hypertension (high blood pressure) is elevated systolic or diastolic levels. In 90 to 95 percent of the diagnosed cases, the specific causes are unknown, although the condition is often linked with family history, and lifestyle. This is referred to as essential hypertension. In the remaining cases, high blood pressure is a symptom of an underlying, often treatable condition, which if corrected, may normalize blood pressure. This less common type is known as secondary hypertension. Hypertension, if left untreated, may contribute to kidney disease, heart attack, stroke, or other debilitating illnesses.

The following standards for assessment of high blood pressure in adults have been established by the Joint National Committee, 2003.

Range Systolic Diastolic Precaution

Classifications Blood Pressure Blood Pressure Measures

Normal <120 <80 Monitor regularly

Pre-hypertension 120 - 139 80 - 99 Contact your physician

–– H Y P E R T E N S I O N ––

Stage 1 140 - 159 90 - 99 Contact your

(Moderate) physician Immediately

Stage 2 160+ 100+ Contact your

(Severe) physician URGENTLY

(JNC-7 report: Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure / 2003)

Remember, only a physician is qualified to interpret the readings obtained from your blood pressure monitor.

No attempt should ever be made at self-diagnosis or treatment.

3.6 Can Hypertension Be Controlled?

Although essential hypertension cannot be cured, it can usually be controlled by altering lifestyle (including diet), adopting a program of exercise, stress management, and, where necessary, with medication under a doctor's supervision.

To help reduce the risk of hypertension, or keep it under control, the American Heart Association (AHA) recommends the following:

• Don't smoke

• Reduce salt and fat intake

• Maintain proper weight

• Exercise regularly

• Have regular physical checkups

3.7 Why Measure Blood Pressure At Home?

Clinical studies have shown improved detection and treatment of hypertension when regular home blood pressure monitoring is done in consultation with a physician.

Blood pressure measured in a doctor's office or hospital setting may cause anxiety and lead to an elevated reading - a condition referred to as "white coat hypertension."

Home measurements generally reduce the "outside" influences on blood pressure readings, and can provide a more comprehensive and meaningful blood pressure history.

Important Note: While it is important to keep an accurate record of your blood pressure measurements, don't be overly concerned by the results of any one measurement. Individual results may be influenced by spiking of your pressure due to diet, anxiety, or mis-measurement resulting from excessive arm movement, or misapplication of the cuff. Many readings taken at the same time each day give a more comprehensive blood pressure history. Always be sure to note the date and time when recording blood pressure and pulse measurements.

For best results, and with time permitting, 3 successive measurements may be taken daily. Make sure to allow at least 5 minute intervals between measurements. Discard any reading that appears suspect and record the average of the remaining readings.

3.8 How is Blood Pressure Measured?

Health care professionals traditionally use a device known as a sphygmomanometer along with a stethoscope - essentially a professional version of the very same instrument you have purchased. The sphygmomanometer is a system consisting of an inflatable bladder contained within a cuff, inflation bulb with air control valve, and pressure measuring manometer

(gauge). The gauge may be mechanical or mercurial.

The cuff is wrapped around the limb and inflated to constrict blood flow to the artery. As pressure is released from the cuff through the deflation valve, blood flow returns to the artery producing pulse beats known as Korotkoff sounds, which are detected with the stethoscope. Systolic pressure is recorded at the onset of these sounds. Diastolic pressure is generally recorded when the sounds disappear (when blood flow to the artery returns to normal).

3.9 How should I record my blood pressure?

Record your measurements by setting up a simple chart in a spiral bound notebook as shown below, or use the included record book.

Date Time Reading Pulse

4/24/98 7:50AM 128/83 72

4/25/98 8:00AM 135/77 77

4/26/98 7:45AM 130/75 71

4/27/98 2:00PM 153/89 80

If you like you can add a column for comments about your condition at the time of measurement, or a listing of any factors that may have influenced your readings (such as "had a cold", or

"just returned from vacation").

For best results, and with time permitting, 3 successive measurements may be taken daily.

Make sure to allow at least 5 minute intervals between measurements. Discard any reading that appears suspect and record the average of the remaining readings. If this method is used, be sure to note that the readings are averaged.

4. COMPONENTS OF YOUR BLOOD PRESSURE MONITOR

The blood pressure monitor is model #6012. The upper arm cuff is for arm circumferences of

(9”-13” / 22.86 - 33.02cm).

Note: Do not force the cuff connection into the opening. If the cuff is too small, call ADC for further information. A larger cuff is available.

125

80

72

T Connector

Systolic

Diastolic

Pulse

ON/OFF

Memory button

Quick release valve

Pumping bulb

Cuff

5. SETTING UP YOUR BLOOD PRESSURE MONITOR

5.1 Inserting the batteries

After you have unpacked your device, insert the batteries. The battery compartment is located on the back side of the device (see illustration). a) Remove cover from the bottom plate, as illustrated.

b) Insert the batteries (4 x size AA ). Always use AA long life batteries or alkaline 1.5v batteries. Do not use rechargeable batteries.

c) If a battery warning appears in the display, the batteries are discharged and must be replaced.

Attention!

• After the battery warning appears, the device will not operate until the batteries have been replaced.

• If the blood pressure monitor will be left unused for long periods, remove the batteries from the device.

• The use of rechargeable batteries is not recommended.

Functional check: Hold the ON/OFF (0/I) button down to test all the display elements. When the device is functioning correctly, all elements should appear.

5.2. Tube connection

Insert the cuff tube into the opening on the side of the instrument, as shown in the diagram.

6. Taking a Measurement

6.1. Before measuring

• Avoid eating and smoking as well as all forms of exertion directly before a measurement. All these factors influence the measurement result. Relax by sitting in an armchair in a quiet atmosphere for about ten minutes before a measurement.

• Remove clothing from your upper arm.

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

• Take measurements at the same time of day, since blood pressure changes during the course of the day.

6.2. Common sources of error

Note: Comparable blood pressure measurements always require the same conditions! (quiet conditions).

• Supporting your arm can increase blood pressure. Make sure you are in a comfortable, relaxed position and do not flex any of the muscles in the arm during the measurement. Use a cushion for support if necessary.

• If the cuff is considerably lower or higher than the heart, an erroneously higher or lower blood pressure will be measured! (Each 15 cm difference in height results in a measurement error of 10 mmHg!)

• Selecting the correct cuff size is of extraordinary importance. The cuff size is dependent upon the circumference of the arm (measured in the center). The permissible range is printed on the cuff. If your cuff does not fit properly, contact ADC.

Note: Only use clinically approved ADC cuffs!

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

• With repeated measurements, blood accumulates in the arm, which can lead to false results. Correctly executed blood pressure measurements should be repeated after a 5 minute pause.

6.3. Fitting the cuff

a) Position the cuff flat on a table with the hook and loop

adhesive side down. Pass the end of the cuff through the

metal ring so that a loop is formed. The hook & loop closure

must be facing outward. (Ignore this step if the cuff has

already been prepared - Figure 1).

(Figure 1)

b) Place the cuff over the left upper arm so that the tube points

in the direction of the lower arm (Figure 2).

c) Lay the cuff on the arm as illustrated. Make certain that the

lower edge of the cuff lies approximately 3/4 to 1”

(2 to 3 cm) above the elbow and that the tube is closer to the

inner side of the arm (Figure 3).

Important!

The 1” Artery Mark “ “ on the cuff must lie

exactly over the brachial artery, which runs down the inner

side of the arm (Figure 4).

d) Tighten the cuff by pulling on the free end and close the cuff

by affixing the hook and loop closure (Figure 5).

(Figure 2)

3/4”- 1”

(Figure 4) cuff

(Figure 3) tube

1” white mark proper cuff placement

(inside of inner arm) e) The cuff should be snug on the upper arm and there should

be enough space to fit 2 fingers between the arm and the

cuff. Clothing must not restrict the arm; any piece of

clothing that does must be removed. Cuffs that don’t fit

properly result in false measurement values. Measure your

arm circumference if you are not sure of proper fit.

A larger size cuff is available (Figure 6).

(Figure 5)

f) Lay the arm on a table (palm upward) so that the cuff is at

the same height as the heart (Figure 7). Make sure that the

tube is not kinked (Figure 8).

g) Remain seated quietly for at least two minutes before you begin the measurement.

Comment: If it is not possible to fit the cuff to the left arm, it can also be placed on the right arm. However, all future measurments should be made using the same arm. Comparable blood pressure measurements always require the same

conditions.

(Figure 7)

(Figure 8)

(Figure 6)

6.4. Measuring procedure

After the cuff has been appropriately positioned, the

measurement can begin:

a) Turn on the instrument by pressing the

On/Off/Memory button. Many icons will appear in

the display for 2 seconds. 3 short beeps follow to

indicate that the instrument is ready.

A blinking «0» is shown in the display.

b) Grasp the bulb with your right hand, (if cuff

is on right arm, use your left hand) and inflate the

cuff to a pressure at least 30 mmHg higher than the

expected systolic pressure. If you do not know the

value of this pressure, inflate to a value of

approximately 160–180 mmHg. The cuff pressure is

shown continuously on the display.

c) After the inflation process, lay down the bulb and remain in a quiet and relaxed sitting position. The measurement now proceeds on its own.

If no measurement takes place and all that appears in the display is a flashing, upwards pointing arrow, pump the bulb again and inflate to a higher pressure. When the instrument detects a pulse, a heart symbol in the display starts to flash and a beep is heard for every heartbeat.

d) When the measurement has been concluded, a long beep tone sounds. The measured systolic and diastolic blood pressure values, as well as the pulse are now displayed. The cuff pressure can now be quickly released by pressing the release valve on the bulb.

6.5. Inflating further

If the cuff is not inflated sufficiently, the measurement

is stopped after a few seconds and a flashing arrow

pointing upwards appears in the display.

It is then necessary to inflate at least 20 mmHg higher

than the previous value. The instruction to inflate

further can appear several times if the pressure is still

not sufficient.

Attention:

If the cuff is inflated too far (over 300 mmHg), «HI»

appears in the display and 3 beeps will sound. The cuff pressure must then be immediately released using the

quick-release valve on the bulb!

As soon as the cuff is inflated sufficiently and

the measurement is proceeding, continue as described under points 5.4 - d.

6.6. Discontinuing a measurement

If it is necessary to interrupt a blood pressure

measurement for any reason, (e.g. the patient feels

unwell) press the quick release valve on the bulb. The

device immediately lowers the cuff pressure

automatically.

6.7. Memory – displaying the last measurement

This blood pressure monitor automatically stores the

last measurement value. When the unit is OFF press

the MEMORY button for at least 3 seconds, and the

last measurement will be displayed.

☞ Further information

To ensure accurate readings, measurements

should not occur soon after each other.

Wait at least 5 minutes in a relaxed position, sitting or

lying down, before you repeat a measurement.

*If taking BP lying down, make sure to support your arm with a towel or

cushion. (according to AHA)

MR

7. ERROR MESSAGES/TROUBLESHOOTING

If an error occurs during a measurement, the

measurement is discontinued and a corresponding error

code is displayed. (example: Er 1)

Error No. Possible Cause(s)

Er 1 The systolic pressure was determined but afterwards the cuff pressure fell below 20 mmHg. The tube may have become unplugged.

Further possible cause: No pulse was detected.

Er 2 The pressure dropped below 20 mmHg without a measurement taking place. The release valve was pressed during the measurement.

Other possible malfunctions and possible solutions:

Malfunction Remedy

The display remains blank when the instrument is switched on although the batteries are in place.

The pressure does not rise although you are pumping the inflation bulb.

• Check battery polarityand correct if necessary.

• If the display is unusual, remove the batteries and insert new batteries.

• Check the connection of the cuff tube and connect properly if necessary.

The device frequently fails to measure the blood • Fit the cuff correctly on the arm.

the blood pressure values or the values measured • Before starting a measurement, make sure are too low or too high. that the cuff is not fitted too tightly. Ensure

clothing is not exerting pressure on the arm

above the measuring position. Take off

articles of clothing if necessary.

• Measure blood pressure again in complete peace and quiet.

Every measurement results in different values, • Blood pressure changes continually. although the device functions normally and normal Your readings may be accurate.

values are displayed. Consult your doctor.

The blood pressure values measured differ from • Record the daily development of the those measured by your doctor. values and consult your doctor about them.

• Anxiety during a doctor visit can

result in higher readings.

☞ Further information

Even for healthy people, blood pressure is subject to fluctuations. Comparable measurements always require the same conditions (Quiet conditions)!

If fluctuations are larger than 15 mmHg, and/or you hear irregular pulse tones on several occasions, consult your doctor.

Contact ADC ® if there are technical problems with your blood pressure monitor. Never attempt to repair the instrument yourself!

Any unauthorized opening of the instrument invalidates all warranty claims!

8. CARE AND MAINTENANCE

a) Do not expose the device to extreme

temperatures, humidity, dust, or direct sunlight.

b) The cuff contains a sensitive air-tight bladder.

Handle this carefully and avoid all types of straining,

twisting, or buckling.

c) Clean the device with a soft, dry cloth. Do not use

gasoline, thinners, or similar solvent. Spots on the

cuff can be removed carefully with a damp cloth

and soapsuds. The cuff is not waterproof.

d) Handle the tube carefully. Do not pull on it, allow

it to twist, or lay it over sharp edges.

e) Do not drop the instrument or treat it roughly in

any way. Avoid strong vibrations.

f) Never open the device!

This will invalidate the

manufacturer warranty.

Periodic recalibration

Sensitive measuring devices must from time to time be

checked for accuracy. We recommend a periodic inspection

of your monitor every 2 years.

Contact ADC ® about the need for an accuracy check.

Gasoline

9. WARRANTY

The blood pressure monitor (6012) is warranted for 5 years from date of purchase. This guarantee includes the instrument and the cuff. The warranty does not apply to damage caused by improper handling, accidents, improper use, or alterations made to the instrument by third parties.

10. QUALITY STANDARDS

Device standard: This device corresponds to the requirements of the U.S.

standards for non-invasive blood pressure monitor

EN1060–1

EN1060–3

DIN 58130

ANSI / AAMI SP10

Electromagnetic compatibility: This device fulfills the stipulations of the

European standard EN 60601–1–2

Clinical testing: Clinical performance testing was carried out in Germany according to the DIN 58130/1997 procedure N6

(sequential).

11. TECHNICAL SPECIFICATIONS

Weight: 284 g (with batteries) / 1.37lbs.

Size: 3.5” (W) x 6.5” (L) x 8” (H)

119mm (W) x 146mm (L) x 60mm (H)

Storage temperature: –20°C to +50°C

Humidity: 15% to 90% relative humidity maximum

Operation temperature: 10°C to 40°C

Display: LCD (Liquid Crystal Display)

Measuring method: Oscillometric

Pressure sensor: Capacitive

Measuring range:

SYS/DIA: 30 to 280 mmHg

Pulse: 40 to 200 per minute

Cuff pressure display range: 0–299 mmHg

Memory: Automatically stores the last measurement

Measuring resolution: 1 mmHg

Accuracy:

Pressure Within ± 3 mmHg, 2% of reading >200mmHg

Pulse ± 5 % of the reading

Power source: 4 AA (batteries)

1.5 V

Accessories: Includes an adult cuff for arm

circumferences 23–33 cm (9”-13”)

Large adult cuff for arm circumferences

33–43 cm (13”-17”) available as a

special accessory.

12. ACCESSORIES

Optional Accessories:

Cuff Sizes:

Adult 850-6013 (9” - 13” / 22.86 - 33.02cm)

Large Adult 850-6013X (13” - 17” / 33.02 - 43.18cm)

13. HOW TO CONTACT US

To register your product and obtain further detailed user information about our products and services visit us at: www.adctoday.com

and follow the links.

For questions, comments, or suggestions call us toll free at:

1-800-232-2670

ADC

55 Commerce Drive

Hauppauge, NY 11788

U.S.A.

Unit 6, PO14 1TH

United Kingdom

IB p/n 93-6012-00 rev 4 english

Inspected in the U.S.A.

Made in China tel: 631-273-9600, 1-800-232-2670 fax: 631-273-9659

www.adctoday.com

email: [email protected]