Medical Portable Sleep Apneas Screening Monitor Polysomnography Device

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Product Description

Basic Information

Model NO.
BM2000A
Certification
CE, FDA, ISO13485
Group
Adult and Child
Color
Blue
Experience
with 15 Years Manufacturer
R&D
Excellent Engineers and Technicians
Quality
ISO13485 Ce0123
Capacity
50000PCS/Year
Sleep Apnea Screening Monitor

Product Description

BM2000A Sleep Monitoring System

Suitable for sleep hypopnea syndrome monitoring. This Sleep Apnea Screening Monitor holds 510K, CE0123, ISO13485, FCC, and RoHS certifications. It accurately captures pulse signals and has been validated in numerous clinical trials to meet professional blood oxygen and pulse rate measurement standards.

Daily Use

Widely Used In Daily Life

BM2000A applies to Aviation, Snorers, Children, Asthma, and COPD patients.

Major Features

  • Suitable for sleep or Apnea respiratory monitoring.
  • Clinical validation against PSG for sleep apnea syndrome diagnosis.
  • Low power consumption: 3.7V lithium battery lasts for more than 20 hours.
  • International certifications: CE, 510K, and more.
  • Multi-user support: Various sensors for infants, children, and adults of different skin colors.
  • Bluetooth Connectivity: Record second-by-second data and generate comprehensive overnight sleep reports.

Operation Process

1 Download the BerrySmartHealth APP from Google Play or Apple Store.
2 Wear the equipment for at least 6 hours of sleep monitoring.
3 Put on the device and wrap foam SpO2 sensor around fingertip.
4 Data is transferred to the mobile phone via Bluetooth.
5 Display and review report on the phone.
6 Reports can be shared easily.

Technical Features

Display: SpO2, PR Battery Type: 3.7v (1000mAh) Rechargeable Lithium
Pulse Rate: 25 - 250bpm (Accuracy: ±2bpm) SpO2: 35% - 100% (Accuracy: ±2% for 80-100%)
Size: 68(L) x 58(W) x 20(D) mm Weight: 50g
Working Voltage: DC 3.4v ~ DC 4.3v Free App: "BerrySmartHealth"

Accuracy Test & Clinical Data

Accuracy Chart 1 Accuracy Chart 2

Correlation=0.98, P-value < 0.0001. Blood oxygen concentration accuracy < 2%.

Comparison: Reference Pulse Oximeter
Pulse Oximeter Range 70 ~ 100 90 ~ 100 80 - < 90 67 - < 80 RESE ≤ 3% (Pass)
Error -0.6 -1.1 -0.9 0.1

Parameter Comparison Charts

Apnea Trend

Apnea Trend

Hypopnea Trend

Hypopnea Trend

Clinical Trial Results

OSAHS Judgment Results
Sensitivity: 94.17% Specificity: 61.21% Accuracy: 89.62%
Diagnosis of Hypoxemia
Sensitivity: 89.29% Specificity: 77.78% Accuracy: 92.59%
PSG vs ROC

PSG vs. ROC Curve Analysis

Standard Configuration

  • 1. Adult probe
  • 2. Child probe
  • 3. Neonate probe
  • 4. Gift box
  • 5. User manual
Configuration 1 Configuration 2

Physical Dimensions: 68(H) × 58(W) × 20(D) mm | Weight: Approx 50g

Frequently Asked Questions

What is the primary use of the BM2000A?
The BM2000A is designed for monitoring sleep apnea and hypopnea syndrome, helping users track blood oxygen levels and pulse rates during sleep.
How long does the battery last?
The device is equipped with a 3.7V rechargeable lithium battery that provides over 20 hours of continuous monitoring on a single charge.
Can children use this monitor?
Yes, the system comes with various sensors suitable for different age groups, including infants, children, and adults.
How do I view my sleep reports?
By connecting the device to the "BerrySmartHealth" App via Bluetooth, you can view, store, and share detailed reports generated from your sleep data.
Is the device medically certified?
Yes, the monitor has international certifications including FDA 510K, CE0123, ISO13485, FCC, and RoHS.
How accurate is the blood oxygen measurement?
The device has an accuracy of ±2% within the 80%-100% range, which has been verified through extensive clinical trials.

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