Berry Bm2000A CE and FDA Polysomnography Device

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Berry Bm2000A CE and FDA 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 Expertise

R&D Department

Excellent Engineers and Technicians

Quality

ISO13485 Ce0123

Transport Package

Box Packaging

HS Code

9018191000

Capacity

50,000 PCS/Year

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, as validated in numerous clinical trials, meeting high standards for blood oxygen and pulse rate measurements.

Widely Used Applications

BM2000A is applicable for Aviation, Snorers, Children, Asthma, and COPD patients.

Major Features

Designed for sleep or Apnea respiratory monitoring, particularly hypopnea.
PSG contrast validated for clinical sleep apnea syndrome diagnosis.
Low power consumption: 3.7V lithium battery lasts more than 20 hours.
International standard compliance with CE and 510K certifications.
Multiple sensor types available for infants, children, and adults.
Bluetooth connectivity for real-time data recording and sleep report generation.

Operation Process

Download the SmartHealth APP.

Wear equipment for at least 6 hours.

Apply foam SpO2 sensor to fingertip.

Transfer data via Bluetooth.

View and share the reports.

Technical Features

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

Clinical Accuracy Test

Correlation = 0.98, P-value < 0.0001 vs Reference ECG

Comparison: Reference Pulse Oximeter
Pulse Oximeter Range	70 ~ 100	90 ~ 100	80 - < 90	67 - < 80	Result
Error	-0.6	-1.1	-0.9	0.1	PASS
RMS Error	1.9	1.7	2.0	2.1	PASS

Trend Analysis & Software Advantage

Analysis Of Clinical Trial Results
Average Accuracy	98.51%
Hypoxemia Diagnosis	Sensitivity: 89.29%	Accuracy: 92.59%
OSAHS Judgment	Sensitivity: 94.17%	Accuracy: 89.62%

Standard Configuration

Adult probe
Child probe
Neonate probe
Gift box
User manual

Frequently Asked Questions

Q: What is the primary use of the BM2000A? A: It is primarily used for monitoring sleep hypopnea syndrome and screening for sleep apnea.

Q: Is the device suitable for all age groups? A: Yes, the system includes various sensors suitable for infants, children, and adults.

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

Q: Can I share my sleep reports with my doctor? A: Yes, the companion app allows you to generate, store, and share sleep reports directly from your mobile phone.

Q: What certifications does this device hold? A: The equipment is internationally certified with CE, FDA (510K), ISO13485, FCC, and RoHS.

Q: How does the device transfer data? A: Data is collected during sleep and transferred to your mobile device via Bluetooth for analysis.