Medical Portable Sleep Apneas Screening Monitor Polysomnography Device

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Medical Portable Sleep Apneas Screening Monitor Polysomnography Device

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Product Description

Basic Specifications

Model NO.

BM2000A

Certification

CE, FDA, ISO13485

Group

Adult and Child

Color

Blue

Experience

15 Years Professional Production

R&D

Excellent Engineers and Technicians

Quality Standard

ISO13485 Ce0123

HS Code

9018191000

Capacity

50,000 PCS/Year

Product Description

System Overview

The BM2000A Sleep Monitoring System is specifically designed for sleep hypopnea syndrome monitoring. It is a reliable solution for accurate blood oxygen and pulse rate measurements, validated through extensive clinical trials.

The monitor is widely applicable in daily scenarios including Aviation, Snoring management, Pediatric care, Asthma, and COPD monitoring.

Major Features

Designed for sleep and apnea respiratory monitoring, especially hypopnea detection.
Clinical grade diagnosis capability through comparative PSG experiments.
Ultra-low power consumption: 3.7V lithium battery lasts for more than 20 hours.
International standard compliance with CE, 510K, and other key certifications.
Versatile sensors suitable for infants, children, and adults of different skin colors.
Bluetooth connectivity with dedicated App to record second-by-second data and generate full-night reports.

Operation Process

1. Download the BerrySmartHealth APP from Google Play or Apple Store.

2. Put on the device and wrap the foam SpO2 sensor around your fingertip.

3. Maintain monitoring for at least 6 hours during sleep.

4. Transfer collected data to your mobile phone via Bluetooth.

5. Review and share the generated sleep reports instantly.

Technical Features

Parameter	Specification
Display	SpO2, PR (Pulse Rate)
Pulse Rate Range	25 - 250bpm (Accuracy: ±2bpm)
SpO2 Range	35% - 100% (Accuracy: ±2% for 80-100%; ±3% for 70-79%)
Battery Type	3.7v (1000mAh) Rechargeable Lithium
Working Voltage	DC 3.4v ~ DC 4.3v
Dimensions	68(L) x 58(W) x 20(D) mm
Weight	50g (including batteries)

Accuracy & Clinical Trials

Blood Oxygen and Pulse Rate Correlation Analysis

Correlation = 0.98, P-value < 0.0001. Devices passed accuracy tests with < 2% variance.

Analysis of Clinical Trial Results

Mean Blood Oxygen Accuracy: 98.51%
Diagnosis of Hypoxemia	Sensitivity: 89.29%	Accuracy: 92.59%
OSAHS Judgment	Sensitivity: 94.17%	Accuracy: 89.62%

Software & Analysis Trends

Apnea and Hypopnea Trends

Software Diagnosis Advantage

PSG vs. ROC Curve

The device shows high correlation with professional PSG (Polysomnography) equipment, ensuring reliable screening for home or clinical environments.

Standard Configuration

Adult probe
Child probe
Neonate probe
Gift box
User manual

Detailed reports can be instantly shared with healthcare providers.

Frequently Asked Questions

Q: What is the main purpose of the BM2000A monitor? A: It is designed for screening and monitoring Sleep Apnea Hypopnea Syndrome (SAHS) by tracking SpO2 and pulse rates throughout the night.

Q: Can this device be used for pediatric patients? A: Yes, the system includes various sensors suitable for infants, children, and adults, accommodating different skin colors and ages.

Q: How long does the battery last on a single charge? A: The built-in 3.7V rechargeable lithium battery can last for more than 20 hours of continuous monitoring.

Q: How do I access my sleep reports? A: You can download the "BerrySmartHealth" App on your smartphone, connect via Bluetooth, and the app will generate and store detailed sleep reports.

Q: Is the measurement accuracy clinically validated? A: Yes, the device has a blood oxygen accuracy of < 2% and has been validated against PSG experiments with high correlation (0.98).

Q: What certifications does the product have? A: The monitor is certified by CE, FDA (510K), and ISO13485, meeting international medical standards.