ADC 6024N Automatic Digital Blood Pressure Monitor Instructions

6024N Automatic Digital Blood Pressure Monitor

Product Information

The Advantage Connect is a non-invasive blood pressure monitor manufactured by Onbo Electronic (Shenzhen) Co., Ltd. and distributed by ADC. The device meets European and United States standards for non-invasive blood pressure monitors, and it complies with the requirements of the Medical Device Directive 93/42/EEC.

The device is tested according to the ESH protocol and ISO81060-2:2013. The device’s technical specifications include:

• Display: LCD (Liquid Crystal Display)

• Weight:

• Dimensions: 4.7 (W) x 3.5 (L) x 2.4 (H) (12cm x 9cm x 6cm) device, 6.5 (W) x 4.13 (L) x 4.13 (H) (16.5cm x 10.50cm x 10.50cm) packaged

• Operating conditions:

• Storage conditions:

• Measuring procedure: Oscillometric, corresponding to Korotkoff
  method: Phase I systolic, Phase V diastolic

• Measurement range: Sys: 60 – 225 mmHg Dia: 40 – 200 mmHg Pulse 40-199 beats per minute

• Memory: 99 measurements for each user

• Cuff pressure display range: 0 – 299 mmHg

• Measuring resolution: 1 mmHg

• Static accuracy:

• Pulse accuracy:

• Power source: 4 AAA batteries

• Battery lifetime: Approx. 920 measurements

Product Usage Instructions

Before using the Advantage Connect blood pressure monitor, read the instructions thoroughly. The device must be used according to instructions to ensure accurate readings.

The device is designed to simplify the measurement of blood pressure and pulse rate at home and deliver consistent, dependable results that can be stored and managed on your smart phone or tablet using the ADC@HomeTM app. To use the device:

1. Insert the batteries into the battery compartment.

2. Wrap the cuff around your upper arm, with the bottom edge of the cuff about 1 inch above your elbow.

3. Make sure the cuff is snug but not too tight. You should be able to fit one finger between the cuff and your arm.

4. Press the “Start” button on the device to begin the measurement.

5. The device will inflate the cuff and then slowly deflate it while measuring your blood pressure and pulse rate.

6. Once the measurement is complete, the device will display your systolic and diastolic blood pressure, as well as your pulse rate.

7. If you want to save the measurement, press the “Memory” button.
   The device can store up to 99 measurements for each user.

8. To turn off the device, press and hold the “Start” button for a few seconds.

Additional cuff sizes are available for this device, including a small adult cuff and a large adult cuff. Make sure you are using the correct size cuff for your arm to ensure accurate readings.

If you have any questions or concerns about using the Advantage Connect blood pressure monitor, contact ADC at 1-800-232-2670.

Introduction and Intended Use$

This manual covers the Advantage Connect® (6024N) and Advantage Connect® Plus (6025N) upper-arm automatic blood pressure monitors. To find the model number of your device, see the rating label located on the bottom of the unit.
Your unit uses the oscillometric method to provide systolic pressure, diastolic pressure, and pulse rate. Other features include AM/PM readings, average mode, irregular heartbeat detection, and a Bluetooth radio to allow data to be stored on a smart phone or tablet equipped with ADC@Home software. Blood pressure readings are obtained during the inflation cycle (as the cuff pumps up), which allows for a slightly faster and much more comfortable measurement process.
The device accommodates two users, each with 99 reading memory, and offers clinically proven accuracy with a user-friendly design.
Before getting started, please read this instruction manual carefully and then keep it in a safe place. Additional documentation is available at: www.adctoday.com/ADCatHome. Please contact your doctor if you have further questions about blood pressure and its measurement.

Contraindications
This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.
This blood pressure monitor is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
WARNING: The device is not suitable for use on: pregnant women; users with implanted electric devices; users with preeclampsia, premature ventricular beats, atrial fibrillation, or peripheral arterial disease; users undergoing intravascular therapy or arteriovenous shunt; or people who received a mastectomy. Consult with your physician prior to using this unit if you suffer from any of these illnesses or conditions.

Medical Disclaimer
The ADC@Home app is not intended for use in the diagnosis, cure, treatment, or prevention of disease. It is not intended for emergency use or real-time monitoring, nor as a substitute for medical care by a healthcare provider. ADC does not make, advise, or influence treatment decisions. Additional information and limitations are available on our website at www.adctoday.com/ADCatHome.

Symbol Definitions
The following symbols are associated with your Advantage Connect.

CE
0044| Meets essential requirements of European Medical Device Directive 93/42/EEC
IP20| Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water

Warnings and Precautions
A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead to patient injury, illness, or death.
Caution statements can appear on the ADC Advantage Connect home blood pressure device, the packaging, the shipping container or in these Instructions for Use.
Before using the device, please review the general cautions presented in the next section as well as the more specific cautions that appear throughout the manual.

• WARNING: The device is not suitable for measuring blood pressure on neonatal infants or children.

• WARNING: Patient harm risk. The ADC@Home app is not an emergency medical response application. The app does not provide alarms or real-time, critical-care monitoring of vital signs. All data that is transmitted with the app must be evaluated by your physician at a later time.

• WARNING: The device is not suitable for use on pregnant women; users with implanted electric devices; users with preeclampsia, premature ventricular beats, atrial fibrillation, or peripheral arterial disease; users undergoing intravascular therapy or arteriovenous shunt; or people who received a mastectomy. Consult with your physician prior to using this unit if you suffer from any of these illnesses or conditions.

• WARNING: Patient harm risk. The ADC@Home app should be used only by the patient for whom it is intended. Save only your own readings on your app. Saving readings that belong to someone else can cause inaccurate information to be sent to your physician, which could lead to improper treatment.

• WARNING: Make sure that you read and understand all user documentation provided with your device to ensure patient safety, accurate readings, and proper operation.
  WARNING: Do not take any therapeutic measures on the basis of a self- measurement. Never alter the dose of a medicine prescribed by a physician. Consult your physician if you have a question about your blood pressure.

• WARNING: Keep the unit out of reach of infants, children, or pets, since inhalation or swallowing of small parts can be dangerous or even fatal.

• WARNING: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the On/Off button immediately to release the air from the cuff. Loosen and remove the cuff from your arm.

• WARNING: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300mmHg or constant pressure 15mmHg for more than 3 minutes) might lead to bruising and discolored skin.

• WARNING: This unit is not suitable for continuous monitoring during medical emergencies or operations.

• WARNING: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.

• WARNING: Do not kink the connection tube during use. The cuff pressure might continuously increase, which could prevent blood flow and result in injury.

• WARNING: Never apply the cuff over damaged skin. This can cause further injury.

• WARNING: If applying to someone else, do not touch output of the  batteries/adapter and the user simultaneously.

• WARNING: Do not use the unit if you are allergic to polyester or synthetic materials.

• WARNING: Excessive tube lengths could cause strangulation if you don’t manage them properly.

• WARNING: Do not connect the air tube to other medical equipment. This could cause air to be pumped into intravascular systems or high pressure, which could lead to serious injuries.

• WARNING: Dispose of according to the local guidelines.

• WARNING: Use only accessories approved by the manufacturer. Using unapproved accessories might cause damage to the unit and injure users.

• WARNING: No modification to this equipment is allowed. Modifying the equipment could damage the unit or endanger the user and void the warranty.

• 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 measuring accuracy.

• CAUTION: The ADC@Home app is intended for use by patients using and inked to ADC-authorized devices.

• CAUTION: The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. The device does not replace a cardiac examination but detects pulse irregularities at an early stage.

• CAUTION: Inaccurate data risk. If you manually enter blood pressure, pulse rate, and weight readings on your app, confirm that the numbers are accurate before saving them.

• CAUTION: To ensure the privacy of your medical information and to protect yourself against cyber threats, review and adjust the security settings on your phone.

• CAUTION: To ensure the privacy of your medical information, only send reports with your medical information to people you trust.

• CAUTION: This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than arm or for functions other than obtaining a blood pressure measurement.

• CAUTION: Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them on the same arm at the same time.

• CAUTION: Before use, make sure the device functions safely and is in proper working condition.

• CAUTION: Use the device in the environment described in this Instructions for Use. Otherwise, you will compromise the device’s performance and reduce its lifetime.

What’s in the Box

Blood Pressure Monitor

Blood Pressure Cuff
Each model has its own cuff.
6024N: Extended wide range D-bar nylon cuff (850-6022N). Fits arm circumference from 22 cm to 42 cm (8.7 in to 16.5 in).
6025N: Self-adjusting wide range rigid cuff (850-6023N). Fits arm circumference from 22 cm to 46 cm (8.7 in to 18.1 in).

Display Icons

Setting Up Your Monitor

Insert the Batteries
Batteries are packaged with the cuff. The battery compartment is on the bottom of the device.

Use AAA long-life or alkaline 1.5V batteries. Do not use rechargeable batteries. Remove batteries if monitor will not be used for long periods.

Using the AC Power Adapter
The Advantage Connect Model Plus (Model 6025N only) can be used with batteries or the included AC adapter.

No power is taken from the batteries while the AC adapter is connected to the device. Use only the AC adapter provided by ADC.

Set the Time and Date
The device will prompt you to reset the date and time each time you replace the batteries.

When the year is flashing…

Repeat Steps 1 and 2 to enter current month, date, hour, and minutes. Note the AM and PM icons when setting the hour.

Connect the Cuff
Make sure cuff connector is fully inserted before taking a reading. Some pressure may be required. You may hear or feel a soft “click” when fully inserted.

Select the Measurement Mode and User
This device has two measurement modes:

• Standard Mode: Takes a single measurement.
• MAM Advantage Takes three measurements and averages as a single reading.
• Average Mode: x3 = Average Mode

For more information on MAM Advantage Average Mode.

Repeat these steps at any time to change the user or Average Mode on or off.

Using Your Monitor with a Smartphone or Tablet
Advanced Bluetooth 4.2 technology allows you to pair your smartphone or tablet with our free ADC@Home app. Once paired, data from your monitor will be sent to the app automatically whenever you take a reading. You can then view, graph, annotate, and share reading with your physician or caregiver.

If you plan to use the ADC@Home app, complete this setup before taking a measurement. For additional instructions on using the app, see www.adctoday.com/ADCatHome.

Install The App

Find and install the app using the appropriate store for your device.

Set Up Your Profile Open the app on your device, then tap Create Account

Fill in required fields (First Name, Last Name, Email, Password) and tap Create Account

Pair Your Device

Open the app and check that Bluetooth is on and discoverable

On the blood pressure monitor

SET
Press and release   The Bluetooth icon will flash on the monitor

If prompted in the app, click Pair

If the monitor is not able to pair within two minutes, Bluetooth will automatically turn off. Press the “SET” button on the monitor to try again.

Once the initial pairing is complete, the monitor will automatically connect to your phone or tablet any time you take a reading and have the app open.

Troubleshooting tips are available at www.adctoday.com/ADCatHome

Preparing for a Measurement

Find time to relax by sitting in an armchair in a quiet atmosphere for about ten minutes before taking a measurement. Avoid eating and smoking as well as all forms of exertion directly before measurement.

• Measure on a bare arm, if possible.
• Always measure on the same arm (normally left).
• Try to take measurements around the same time each day.
• For additional tips and information on obtaining accurate readings.

6024N: Fitting the D-Bar Cuff

1. Loop cuff through ring
2. Position cuff over left arm
3. Tighten cuff
4. Verify fit

If the cuff provided with your unit is too big or small, please call 1-800-232-2670. Only use approved ADC cuffs.

6025N: Fitting the Rigid Cuff

1. Wrap cuff around arm
2. Position cuff over left arm
3. Press the Hook-and-loop closure together

If the cuff provided with your unit is too big or small, please call 1-800-232-2670. Only use approved ADC cuffs.

If using the ADC@Home app, open the app on your phone or tablet before continuing to the measurement.

Taking a Measurement

If using the ADC@Home app, open the app on your phone or tablet before starting the measurement. For information on setting up the app, see pages 14-15.

i If you get an “Err 3” message, please check to ensure the cuff is fully connected to the monitor. The connector should sit nearly flush with side of monitor. Some pressure may be required when inserting.

You’ll hear a slight pause when inflation nears 30 mmHg as the inflation process calibrates for optimal comfort.

if MAM Average Mode is on, countdown to the second or third reading will appear and the next reading will start.

When measurement has concluded, the systolic pressure, diastolic pressure, and pulse rate appear on display

The monitor automatically attempts to send the reading to the ADC@Home app
If you are connected to the app, the new data will appear on that screen in a few seconds

If the monitor is not able to pair within two minutes, Bluetooth will disconnect and the device will turn off.

Press and release to turn off

Stopping a Measurement
You can stop a measurement at any time.

Press and release Unit will turn off and cuff will deflate

If you experience any discomfort, such as pain in the arm, stop the measurement immediately and remove the cuff.

Using the Memory

M. Each measurement is stored in memory with the data and time it was taken.
Up to 99 readings are stored for each of two users. Be sure you are viewing the measurements for the correct user.

Once the maximum memory capacity of 99 is reached, the next new reading will overwrite the oldest value currently in memory.
This only affects readings that are stored on the monitor itself; data within the ADC@Home app is not impacted.

Viewing Stored Readings

The irregular heartbeat icon will appear if it was detected during that reading.

M. Press and release to view the next stored reading

When finished, press and release to turn unit off

Clearing the Memory
Measurements cannot be individually deleted once in the monitor’s memory, but you can clear a user’s entire measurement history.

Before proceeding, be certain you won’t need to refer to the data in the future. Use the ADC@Home app or keep a written record if needed.

Confirm that the monitor is set for the correct user. For more information on changing the user,.

M
Press and hold for 5 seconds

SET
Press to confirm

Clearing the memory only affects readings that are stored on the monitor itself; if you are using the ADC@Home app, data within the app is not impacted.

MAM Advantage Average Mode

In MAM Advantage Average Mode, three measurements are automatically taken in succession and the result calculated and displayed as a single, averaged reading. Averaged readings are more reliable than those from single measurements.

For more information on turning Average Mode on and off, see page 13.

During measurement, you’ll see a 1, 2, or 3 in the bottom right-hand corner of the display to indicate which reading currently being taken.

Do not remove the cuff between measurements.

There is a break of 15 seconds between the measurements. An on- screen countdown indicates the remaining time before the second and third readings begin.

The calculated average is shown when all three readings are complete. Individual results from the three separate measurements are not displayed.

If an error occurs during any of the measurements that reading will be discarded and an additional measurement is taken automatically.

Irregular Heartbeat Detector

The appearance of this icon means allorhythmia, or irregular, heartbeat was detected. If the symbol appears, then certain abnormalities in heartbeat frequency were detected during the measurement. This indicator is only a caution.

It is important that you are relaxed, remain still, and do not talk during measurement.

In most cases, the appearance of an irregular heartbeat is no cause for concern. However, if the symbol appears on a regular basis (e.g., several times a week with measurements taken daily) we advise you to speak with your doctor.

Information for the doctor on frequent appearance of the Irregular Heartbeat Detector:
This device is an oscillometric blood pressure monitor that also analyzes pulse irregularity during measurement. The device is clinically tested. The arrhythmia symbol is displayed after the measurement. If the symbol appears more frequently (e.g., several times per week on measurements performed daily) we recommend the patient to seek medical advice. This device does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Traffic Light Indicator
The red, orange, yellow, and green bars along the left side of the display offer a visual representation of healthy and unhealthy blood pressure ranges. The scale and classifications are based on standards established by the American Heart Association and American College of Cardiology in 2017.

• Only a physician is qualified to interpret the readings obtained from blood pressure monitor. No attempt should ever be made at self-diagnosis or treatment.
• Readings below 90 (sys) and/or 60 (dia) may be considered hypotensive. Consult your physician.

Performing Reliable Measurements

• When taking blood pressure, ensure all steps involved in the process are properly observed. Small variations in technique can cause large variances in measurements. Comparable blood pressure measurements require the same conditions.

• Efforts by the user to support the arm can increase blood pressure. Make sure you are in a comfortable, relaxed position and do not flex any of the muscles in the measurement arm during the measurement. Use a cushion for support if necessary.
  If the arm artery lies considerably lower or higher than the heart, blood pressure may read erroneously higher or lower. Each 15 cm (6 inch) difference in height between your heart and the cuff results in a measurement error of 10 mmHg.

• Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is extremely important. Cuff size is dependent upon the circumference of the arm (measured in the center). Each model has its own cuff: 6024N comes with cuff 850 6022N, which fits arm circumference from 22 cm to 42 cm (8.7 in to 16.5 in) 6025N comes with cuff 850-6023N, which fits arm circumference from 22 cm to 46 cm (8.7 in to 18.1 in)

• Other cuff sizes are available. If the cuff provided with your unit is not suitable for your use (i.e., too big or too small), please call 1-800-232-2670. Only use approved ADC cuffs.

• ADC cuffs have specially designed markings to promote the precise and accurate determination of blood pressure. Please review the section on fitting your cuff on pages 16-17.

• A loose cuff or a sideways protruding air pocket causes false measurements. Ensure that cuff is properly applied.

• With repeated measurements, blood accumulates in the arm, which can lead to false results.

• Consecutive measurements in average mode are repeated with a 15-second pause between readings. If you want to take a second set of average mode readings, be sure to wait at least one minute before starting the sequence again.

• To learn more about blood pressure, see our informational document About Blood Pressure, at www.adctoday.com/ADCatHome.

Error Messages and Troubleshooting

If an error occurs during a measurement, the measurement is interrupted, and a corresponding error code is displayed, example <Err 3>.

Error No. Description Possible cause(s) / Solutions

Err 1| Signal too weak| The pulse signals on the cuff are too weak. Reposition the cuff and repeat the measurement.
---|---|---
Err 2| Error Signal| During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat measurement, keeping arm still.
Err 3| Abnormal cuff| An adequate pressure cannot be generated in the pressure cuff. A leak may have occurred.

Check that the cuff connector is securely inserted into the monitor. You may hear or feel a soft “click” when inserting and the connector will sit nearly flush with side of monitor.

Err 5| Abnormal result| The measuring signals are inaccurate, and no result can therefore be displayed. Read through the checklist for performing reliable measurements on pages 25-26. Repeat the measurement.
HI| Pulse or cuff| The pressure in the cuff is too high (over 299 mmHg) or the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.
LO| Pulse too low| The pulse is too low (less than 40 beats per minute). Relax for 5 minutes and repeat the measurement.

Other possible errors and their solutions
If problems occur when using the device, the following points should be checked:

Malfunction                                               Remedy

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

1. Check battery installation/polarity.
2. Remove the batteries and if the display is unusual, then exchange them for new ones. Check polarity.

---|---
The pressure does not rise although the pump is running.| Check the connection of the cuff tube and connect properly.
The device frequently fails to measure, or the values measured are too low or high.|

1. Fit the cuff correctly on the arm.
2. Confirm proper measuring technique as described Preparing for a Measurement on page 16 and Performing Reliable Measurements on page 25.

Every measurement results in different values.|

1.  Confirm proper measuring technique as described Preparing for a Measurement on page 16 and Performing Reliable Measurements on page 25.
2. Consult our informational document About Blood Pressure, at www.adctoday.com/ADCatHome.

Blood pressure values differ from those measured at the doctor’s.

• Blood pressure is subject to fluctuations even in healthy people. Please remember that comparable blood pressure measurements always require the same time and the same conditions!
• If your blood pressure readings regularly fluctuate more than 15 mmHg, or if you repeatedly see the irregular heartbeat icon, consult your doctor.
• If you experience technical malfunctions with the monitor, contact the dealer where you bought the device or ADC. Never attempt to repair the instrument yourself! Unauthorized opening invalidates the warranty.

Care and Maintenance

• Clean the monitor only when necessary. Use a soft, dry cloth with a 70% isopropyl alcohol solution or a 10% chlorine bleach/90% water solution (e.g., standard bleach wipe).

• Spots on the cuff can be removed carefully with a damp cloth and soapsuds.

• Do not drop the monitor.

• Avoid stress when handling the cuff and tubing. Twisting or buckling can damage the sensitive air-tight bubble. Keep away from sharp edges.

• Do not clean with gas, thinners, or similar solvents.

• Do not submerge any parts in water.

• Do not expose to extreme temperatures, humidity, dust, or direct sunlight.

• Never open the monitor! This invalidates the manufacturer’s warranty.

Technical Specifications

• Display: LCD (Liquid Crystal Display)
• Weight: 270.5 ±5g (including batteries)
• Dimensions: 4.7″ (W) x 3.5″ (L) x 2.4″ (H) (12cm x 9cm x 6cm) device 6.5″ (W) x 4.13″ (L) x 4.13″ (H) (16.5cm x 10.50cm x 10.50cm) packaged
• Operating conditions: 50°F to 104°F (10°C to 40°C) 15 to 90% relative maximum humidity
• Storage conditions: -4°F to 131°F (-20°C to 55°C)
• Measuring procedure: Oscillometric, corresponding to
• Korotkoff method: Phase I systolic, Phase V diastolic
• Measurement range: Sys: 60 – 225 mmHg
• Dia: 40 – 200 mmHg
• Pulse 40-199 beats per minute
• Memory: 99 measurements for each user
• Cuff pressure display range: 0 – 299 mmHg
• Measuring resolution: 1 mmHg
• Static accuracy: Pressure within ±3 mmHg
• Pulse accuracy: ±5% of the read-out value
• Power source: 4 AAA batteries
• Battery lifetime: Approx. 920 measurements

Additional cuff sizes  are also available for these devices:
Item No.                  Size                   Range

• 850-6021NSA Sm. Adult 6.7″-8.7″ (17-22 cm)
• 850-6022NX Lg. Adult 12.5″-20.4″ (32-52 cm)

Warranty
This blood pressure monitor is warranted for five years from date of purchase. This warranty 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. The warranty is only valid after the product is registered online at www.adctoday.com/support /warranty-registration.

Terms and Conditions
Use of the ADC@Home app is governed by the Terms and Conditions available in the app and on our web site at www.adctoday.com/ADCatHome.

Quality Standards
This device is manufactured to meet the European and United States standards for non-invasive blood pressure monitors: EN 1060-3/-4; IEC 60601-1;
IEC 60601-1-2 (EMC); IEC 80601-2-30; IEC 60601-1-11.
This device complies with the requirements of the Medical Device Directive 93/42/EEC.

Technical alterations reserved.

This device is tested according to the ESH protocol and ISO81060-2:2013.

How to Contact Us

• Tel: 1-800-ADC-2670
• Email: info@adctoday.com www.adctoday.com

References

• American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT
• ADCatHome | American Diagnostic Corporation

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