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DaliaSense

FDA 510(k) cleared, clinically validated blood pressure monitor with integrated DaliaHealth app connectivity for comprehensive health tracking.

FDA 510(k) Cleared
Clinically Validated
DaliaSense Blood Pressure Monitor

1Device Description & Intended Use

Product Description

The DaliaSense Digital Blood Pressure Monitor is an automatic, non-invasive device designed to measure systolic and diastolic blood pressure as well as pulse rate in adult users. The device features an adjustable arm cuff, OLED display, and Bluetooth connectivity for integration with the DaliaHealth mobile application.

Intended Use

The DaliaSense BP Monitor is intended for use in measuring blood pressure and pulse rate in adult individuals (18 years and older) in a home healthcare environment. It is designed for use on the upper arm and provides measurements using the oscillometric method.

Intended Users

  • Adults (18 years and older) for self-monitoring at home
  • Caregivers monitoring patients in home settings
  • Healthcare professionals for clinical reference
DaliaSense portable design
DaliaSense OLED display
DaliaSense arm cuff

2Warnings

Important Safety Warnings

Please read all warnings carefully before using the DaliaSense BP Monitor.

  • NOT FOR DIAGNOSTIC PURPOSES: This device is intended for general wellness and health monitoring only. It is not intended to diagnose, treat, cure, or prevent any disease. Always consult a qualified healthcare professional for medical advice and diagnosis.

  • DO NOT use this device on infants, children, or individuals who cannot express themselves.

  • DO NOT use the device on an arm with an intravenous (IV) drip or blood transfusion in progress.

  • DO NOT use on an arm that has undergone mastectomy or lymph node removal on the same side.

  • DO NOT use the device if you have severe blood flow problems or blood disorders.

  • DO NOT use on injured or wounded areas of the arm.

  • SEEK IMMEDIATE MEDICAL ATTENTION if you experience chest pain, severe headache, shortness of breath, or other symptoms of a medical emergency, regardless of your blood pressure reading.

  • DO NOT make any changes to your medication or treatment based solely on readings from this device. Always consult your healthcare provider.

3Precautions

Before Measurement

  • Rest for at least 5 minutes before taking a measurement.

  • Avoid caffeine, alcohol, smoking, and exercise for at least 30 minutes before measurement.

  • Empty your bladder before taking a measurement.

  • Do not talk, move, or cross your legs during measurement.

  • Take measurements at the same time each day for consistent results.

During Use

  • Ensure the cuff is positioned correctly on bare skin, 1-2 cm above the elbow.

  • The cuff should be snug but not too tight - you should be able to slip two fingers underneath.

  • Wait at least 2 minutes between consecutive measurements.

Device Care

  • Store the device in a cool, dry place away from direct sunlight.

  • Do not expose the device to extreme temperatures or humidity.

  • Do not drop, disassemble, or attempt to repair the device yourself.

  • Clean the device and cuff with a soft, dry cloth. Do not use water or solvents.

4Instructions for Use

Step-by-Step Guide

1

Prepare for Measurement

Sit in a comfortable chair with your feet flat on the floor. Rest for 5 minutes before taking a measurement. Remove any tight-fitting clothing from your upper arm.

2

Apply the Cuff

Slide the cuff onto your left upper arm, positioning it 1-2 cm above your elbow. The artery marker on the cuff should align with your brachial artery (inner arm). Secure the cuff snugly but comfortably.

3

Position Your Arm

Rest your arm on a flat surface (such as a table) with your palm facing upward. The cuff should be at the same level as your heart. Keep your arm relaxed and supported throughout the measurement.

4

Start Measurement

Press the START button on the device. The cuff will automatically inflate and then slowly deflate. Remain still and do not talk during the measurement process, which takes approximately 30-60 seconds.

5

Read Your Results

Once complete, your systolic pressure, diastolic pressure, and pulse rate will be displayed on the OLED screen. The device stores up to 100 readings for your reference.

6

Sync with DaliaHealth App (Optional)

Enable Bluetooth on your smartphone and open the DaliaHealth app. Your readings will automatically sync to the app for tracking, analysis, and sharing with your healthcare provider.

Normal

Systolic: Less than 120 mmHg

Diastolic: Less than 80 mmHg

Elevated

Systolic: 120-129 mmHg

Diastolic: Less than 80 mmHg

High Blood Pressure Stage 1

Systolic: 130-139 mmHg

Diastolic: 80-89 mmHg

High Blood Pressure Stage 2

Systolic: 140 mmHg or higher

Diastolic: 90 mmHg or higher

5Technical Specifications

Measurement

MethodOscillometric
Pressure Range0-299 mmHg
Pulse Range40-180 bpm
Accuracy±3 mmHg / ±5%
Cuff Size22-42 cm (8.7-16.5 in)

Device

DisplayOLED Screen
Memory100 readings
BatteryRechargeable Lithium
Battery Life~500 measurements
ChargingUSB-C
ConnectivityBluetooth

Operating Conditions

Temperature

10°C - 40°C (50°F - 104°F)

Humidity

15% - 90% RH (non-condensing)

Altitude

Up to 3000m (10,000 ft)

6Troubleshooting

Error message or no reading displayed

  • Ensure the cuff is properly positioned and not too loose or tight
  • Remain still and do not talk during measurement
  • Check that the battery is adequately charged
  • Wait 2 minutes and try again

Readings seem unusually high or low

  • Rest for 5 minutes before retaking the measurement
  • Ensure your arm is at heart level
  • Avoid caffeine, exercise, and stress before measuring
  • Take multiple readings and record the average

Device won't turn on

  • Charge the device using the provided USB-C cable
  • Ensure the charging cable is properly connected
  • Allow at least 30 minutes of charging before use

Bluetooth connection issues

  • Ensure Bluetooth is enabled on your smartphone
  • Keep the device within 10 meters of your phone
  • Restart the DaliaHealth app and try reconnecting
  • Remove and re-pair the device in your Bluetooth settings

Need Help?

If you have questions about your DaliaSense BP Monitor or need technical support, our team is here to help.

DaliaSense

DaliaSense Blood Pressure Monitor | FDA 510(k) Cleared

Distributed by DaliaHealth | info@daliahealth.com

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