Sleep Fairy Apnea Monitor Equipment at Hospital Report

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Sleep Fairy Apnea Monitor Equipment at Hospital Report

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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 Department

Excellent Engineers and Technicians

Quality

ISO13485 Ce0123

Transport Package

a Box

Specification

Trademark

Berry

Origin

China

HS Code

9018191000

Production Capacity

50000PCS/Year

BM2000A Sleep Monitoring System

Suitable for sleep hypopnea syndrome monitoring

Instructions

The Sleep Apnea Screening Monitor has 510K, CE0123, ISO13485, FCC, RoHS certifications. It accurately captures pulse signals and blood oxygen levels, validated through numerous clinical trials to meet high-standard measurement needs.

Widely Used In Daily Life

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

Major Features

Specifically designed for sleep apnea and hypopnea respiratory monitoring.
Clinically validated against PSG (Polysomnography) for reliable diagnosis.
Low power consumption: 3.7V lithium battery lasts for more than 20 hours.
International certifications including CE and 510K.
Multiple sensor types available for infants, children, and adults of all skin colors.
Bluetooth connectivity: Records every second of data to generate comprehensive sleep reports via the mobile app.

Operation Process

Download the BerrySmartHealth APP from Google Play or Apple Store.

Wear the equipment for at least 6 hours of sleep monitoring.

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

Data is transferred to the mobile phone automatically via Bluetooth.

View and analyze the generated report on your phone.

Reports can be shared easily for professional consultation.

Technical Features

Display: SpO2, PR	Battery: 3.7v (1000mAh) Rechargeable Lithium
Pulse Rate: 25 - 250bpm (Accuracy: ±2bpm)	SpO2 Range: 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 & PSG Comparison

Comparison: Reference Pulse Oximeter
Berry Pulse Oximeter	70 ~ 100	90 ~ 100	80 - < 90	67 - < 80	RESE ≤ 3% (Range 70-100%)
# pts	240	79	81	81	RESE ≤ 3% (Range 70-100%)
Error	-0.6	-1.1	-0.9	0.1	Pass
Root Mean Square Error	1.9	1.7	2.0	2.1	Pass

Software & Diagnosis Advantages

PSG vs. ROC Curve: Demonstrates high sensitivity and specificity in clinical diagnosis compared to gold-standard polysomnography.

Analysis Of Clinical Trial Results

Mean Blood Oxygen Accuracy: 98.51%
Diagnosis of Hypoxemia
Sensitivity: 89.29%	Specificity: 77.78%	Accuracy: 92.59%
OSAHS Judgment Results
Sensitivity: 94.17%	Specificity: 61.21%	Accuracy: 89.62%