Yuwell (YE660E)

Blood Pressure (BP) monitoring devices are used for:

1. Hypertension Diagnosis and Management

• Monitoring of blood pressure in patients with known or suspected hypertension (primary or secondary).
• Used to confirm diagnosis of white-coat or masked hypertension.
• Essential in evaluating efficacy of antihypertensive treatment regimens.

2. Hypotension Detection

• Evaluation of symptomatic hypotension, including postural (orthostatic) hypotension or autonomic failure.
• Assessment during vasovagal episodes or dehydration-related low BP.

3. Cardiovascular Risk Screening

• Routine screening in adults aged 18 years and older as per global hypertension guidelines.
• Monitoring in patients with risk factors such as diabetes, renal disease, or heart failure.

4. Pregnancy-Related Monitoring

• For early detection and regular monitoring of gestational hypertension or preeclampsia.

5. Ambulatory and Home Monitoring

• Ambulatory Blood Pressure Monitoring (ABPM) for 24-hour BP trends in resistant hypertension or nocturnal BP assessment.
• Home Blood Pressure Monitoring (HBPM) in patients requiring regular monitoring outside clinical settings.

6. Hospital and Critical Care Monitoring

• Used for real-time monitoring in post-operative care, ICU, emergency settings, and cardiac units.

(Device Usage Instructions in Place of Medication Dosing)

A. General Usage Instructions:

• Sit upright with back supported and feet flat on the floor.
• Rest for at least 5 minutes before taking measurement.
• Apply cuff to bare upper arm at heart level, ensuring correct cuff size.
• Do not talk or move during measurement.
• Repeat reading after 1–2 minutes; take 2–3 readings and average them.

B. Pediatric Patients:

• Use a pediatric-sized cuff.
• Ensure the child is calm and seated appropriately.
• Interpret readings using age-specific BP percentiles.

C. Elderly & Obese Patients:

• Use larger cuffs as necessary for accurate readings.
• May require assistance in positioning the arm properly.
• For arrhythmic patients, use devices validated for irregular heart rhythms.

D. Types of Devices:

• Manual (Aneroid) Sphygmomanometer: Requires trained personnel and stethoscope.
• Digital (Automatic) BP Monitor: Suitable for home use with self-inflating cuff and digital display.
• Wrist Devices: Portable but less accurate; correct positioning at heart level is essential.
• Ambulatory Monitors: Worn for 24-hour automated readings in resistant or nocturnal hypertension cases.

Blood Pressure (BP) monitoring devices function by detecting arterial blood flow changes during cuff inflation and deflation. The most common method is the oscillometric technique, where the device senses pressure oscillations caused by arterial pulsation beneath the cuff. These oscillations are used to calculate systolic and diastolic pressure. In auscultatory methods, Korotkoff sounds are detected using a stethoscope to identify systolic (first sound) and diastolic (disappearance of sound) pressures. Digital monitors use algorithms to process these signals and display BP readings, helping users assess cardiovascular status.

Not applicable, as BP monitors are non-pharmacological medical devices. However, functional characteristics include:

• Measurement Time: 30–60 seconds per reading.
• Memory Storage: Most digital models store 30–120 previous readings; some models support multiple users.
• Connectivity: Some devices feature Bluetooth or Wi-Fi for synchronization with mobile health applications or electronic health records.
• Battery Use: Typically powered by AA/AAA batteries or rechargeable lithium-ion batteries.

Not applicable under FDA Pregnancy Categories, as BP monitors are non-drug devices.

However:

• Use During Pregnancy:
• Safe and routinely recommended for monitoring blood pressure during pregnancy.
• Essential in early detection and monitoring of preeclampsia and gestational hypertension.
• Use During Lactation:
• No known risk.
• Devices are safe for use while breastfeeding.

• Medical Device Class: Diagnostic Device
• Type: Non-invasive Blood Pressure (NIBP) Monitor
• Subtypes:
• Manual Aneroid Monitor
• Automatic Digital Arm Monitor
• Wrist BP Monitor
• Ambulatory BP Monitor

• Severe injury, open wound, or infection at the site of cuff placement.
• Arm with arteriovenous (AV) fistula or recent surgical graft (e.g., dialysis access).
• Post-mastectomy arm with lymph node dissection due to risk of lymphedema.
• Severe peripheral arterial disease (may result in inaccurate readings).
• Patients unable to remain still or cooperate during the measurement process.

• Cuff Size Accuracy: Incorrect cuff size may result in falsely high or low readings.
• Regular Calibration: Manual monitors require professional calibration every 6–12 months.
• Arrhythmias: Some devices may provide inaccurate readings in atrial fibrillation or other irregular rhythms.
• Movement & Talking: Can lead to incorrect measurements; users must remain still and silent.
• Digital Device Accuracy: Prefer models validated by recognized bodies (e.g., AAMI, BHS, or ESH).
• Avoid Measuring Right After Exercise, Eating, or Smoking: Wait at least 30 minutes for reliable results.

BP monitoring is generally safe. Possible side effects are rare and typically minor:

Common (Mild):

• Temporary discomfort or tightness during cuff inflation.
• Redness or mild bruising on the arm.

Uncommon/Rare:

• Superficial blood vessel rupture in frail patients.
• Numbness or tingling in the limb if cuff pressure is applied too long.
• Vasovagal response in sensitive individuals.

Not applicable in the traditional sense.

However, functional or reading accuracy may be affected by:

• Cardiac Arrhythmias: May cause erratic readings on oscillometric devices.
• Electrical Interference: Use away from electromagnetic devices or mobile phones.
• Improper Use With Other Monitors: BP readings may be altered if simultaneously using devices like pulse oximeters on the same limb.

• AHA/ACC Guidelines (2023):
• Emphasize the use of clinically validated upper-arm monitors.
• Recommend home BP monitoring for all hypertensive patients.
• Encourage average of ≥2 readings, twice daily, over multiple days for diagnostic accuracy.
• WHO Recommendations:
• Promote availability of affordable, validated digital BP monitors for global hypertension control initiatives.
• FDA Update:
• Reinforced post-market surveillance requirements for BP monitors with digital data connectivity and telehealth integration.

• Temperature: Store between 10°C and 40°C (50°F to 104°F).
• Humidity: Keep in a dry environment; relative humidity <85%.
• Light: Protect from direct sunlight and extreme heat.
• Battery Maintenance:
• Remove batteries if the device is unused for an extended period.
• Replace depleted batteries promptly to avoid leakage.
• Cuff Handling:
• Keep clean and dry; clean with a soft cloth, not submerged in water.
• Do not twist or fold tightly; store flat or loosely coiled.
• Calibration Needs:
• Digital monitors: Factory calibrated, revalidation every 2–3 years recommended.
• Manual aneroid devices: Require regular calibration by healthcare providers.