📋 Basic Specifications
Certification
CE, FDA, ISO13485
Experience
with 15 Years Manufacturer
🔍 Product Overview
BM2000A Sleep Monitoring System
Suitable for sleep hypopnea syndrome monitoring. This Sleep Apnea Screening Monitor has 510K, CE0123, ISO13485, FCC, RoHS certifications. It accurately captures pulse signals and has been validated in numerous clinical trials.
🌟 Major Features
Monitoring Range: Suitable for sleep or Apnea respiratory monitoring, especially Apnea and hypopnea monitoring.
Clinical Use: Through contrast experiments with PSG, it can be used for the diagnosis of clinical sleep apnea syndrome.
Low Power: The 3.7V lithium battery can last for more than 20 hours.
Universal Fit: Various types of sensors suitable for infants, children, and adults of different skin colors.
Smart Connection: Sleeping applet connects via Bluetooth to record data every second and generate full-night reports.
🚀 Operation Process
1
Download the Smart Health 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 the foam SpO2 sensor around the fingertip.
4
The collected data is transferred to the mobile phone via Bluetooth.
5
Display and analyze the report on your phone.
⚙️ Technical Features
| Display: SpO2, PR |
Battery: 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 |
Connectivity: Bluetooth Free App |
📊 Accuracy & Clinical Trials
Blood Oxygen Concentration & Pulse Rate Accuracy Tests
| Comparison: Reference Pulse Oximeter |
| Pulse Oximeter Range |
70 ~ 100 |
90 ~ 100 |
80 - < 90 |
67 - < 80 |
RESE ≤ 3% (Range 70~100%) |
| # pts |
240 |
79 |
81 |
81 |
| Error |
-0.6 |
-1.1 |
-0.9 |
0.1 |
Status: Pass |
| RMS Error |
1.9 |
1.7 |
2.0 |
2.1 |
📈 Parameter Analysis
Apnea Trend Analysis
Hypopnea Trend Analysis
📉 Clinical Results Summary
| Mean Blood Oxygen Accuracy |
| Average blood oxygen calculation 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% |
📦 Standard Configuration
- ✅ 1x Adult probe
- ✅ 1x Child probe
- ✅ 1x Neonate probe
- ✅ 1x Gift box
- ✅ 1x User manual
📏 Physical Identity
Dimension
68(H) × 58(W) × 20(D) mm
Weight
About 50g (including batteries)
Frequently Asked Questions
Who is the BM2000A suitable for?
It is designed for individuals requiring sleep hypopnea syndrome monitoring, including adults, children, and infants. It is also applicable for those with Asthma, COPD, or snorers.
How long can the device monitor on a single charge?
The built-in 3.7V rechargeable lithium battery provides over 20 hours of continuous operation, making it ideal for full-night sleep studies.
How do I view my sleep reports?
Data is transferred via Bluetooth to the specialized Smart Health App. The app analyzes the data every second to generate a comprehensive sleep report that can be shared.
Is the blood oxygen measurement accurate?
Yes, the device has passed clinical trials with a mean blood oxygen accuracy of 98.51%. It meets 510K requirements with oxygen concentration accuracy under 2%.
What certifications does this device hold?
The BM2000A is fully certified with CE0123, FDA (510K), ISO13485, FCC, and RoHS, ensuring it meets international medical standards.
What is included in the standard package?
The package includes the main device, probes for adults, children, and neonates, a user manual, and a high-quality gift box.
FoysMed Solutions
