Medical Portable Sleep Apneas Screening Monitor Polysomnography Device

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Product Description

Basic Info

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
Trademark
Berry
Origin
Shanghai, China
HS Code
9018191000
Production Capacity
50000PCS/Year

Product Description

BM2000A Sleep monitoring system

BM2000A Sleep monitoring system

Suitable for sleep hypopnea syndrome monitoring

Instructions

Berry Sleep Apnea Screening Monitor has 510K, CE0123, ISO13485, FCC, RoHS and we can meet most people's measurements of blood oxygen and pulse rate. It can accurately capture pulse signals and has been validated in numerous clinical trials.

Sleep Monitor Use Cases

Widely Used In Daily Life

BM2000A applies to Aviation, Snorer, Child, Asthma, COPD.

Major Features

  • Equipment is suitable for sleep or Apnea respiratory monitoring, especially Apnea and hypopnea monitoring.
  • Through contrast experiments with PSG, it can be used for the diagnosis of clinical sleep apnea syndrome.
  • Product is low power consumption, The 3.7V lithium battery can last for more than 20 hours.
  • The equipment has approved international CE, 510K, and other certifications.
  • Various types of sensors, which are suitable for infants and children adults and people of different ages and people of different skin colors.
  • Sleeping applet can be connected by the bluetooth. Record the data of every second actually, store and feedback the monitoring data of the whole night to the device, so as to generate the sleep report.

Operation Process

01Download the BerrySmartHealth APP from Google Play and Apple Store.
02Wear the equipment to keep at least 6 hours sleep monitoring.
03Put on the device and wrap foam spO2 sensor around fingertip.
04The collected data is transferred via bluetooth.
05Display report on phone.
06Reports can be shared.

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)x58(W)x20(D)mm Weight: 50g
Working Voltage: DC 3.4v ~ DC 4.3v Free App: "BerrySmartHealth"

Accuracy Test & Results

Blood Oxygen Concentration & Pulse Rate Test
Accuracy Chart 1 Accuracy Chart 2

Berry Product Rate VS Reference heart rate ECG (Correlation=0.98)

Comparison: Reference Pulse Oximeter
Berry Pulse Oximeter 70 ~ 100 90 ~ 100 80 - < 90 67 - < 80 RESE≤3% Within range
Error -0.6 -1.1 -0.9 0.1

Data Trends & Analysis

Apnea Trend

Apnea Trend

Hypopnea Trend

Hypopnea Trend
Blood Oxygen Results Diagnosis Results PSG vs ROC Curve

Clinical Trial Analysis

Mean Blood Oxygen Results
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%

Configuration & Identity

Standard Configuration

Standard Configuration:

  • Adult probe
  • Child probe
  • Neonate probe
  • Gift box
  • User manual
Mobile Reports

Physical Identity:
Dimension: 68(H) × 58(W) × 20(D) mm
Weight: About 50g (with the batteries)

Frequently Asked Questions

What is the primary use of the BM2000A?
It is primarily used for monitoring sleep apnea and hypopnea syndrome, as well as general respiratory and blood oxygen monitoring.
Is it suitable for children and infants?
Yes, the device comes with various types of sensors suitable for infants, children, and adults of different ages.
How long does the battery last on a full charge?
The 3.7V rechargeable lithium battery can last for more than 20 hours of continuous use.
Can I view the data on my smartphone?
Yes, the device connects via Bluetooth to the "BerrySmartHealth" app (available on Google Play and Apple Store) to generate and share sleep reports.
What certifications does the BM2000A hold?
The product is internationally recognized with FDA 510K, CE0123, ISO13485, FCC, and RoHS certifications.
How accurate is the blood oxygen measurement?
Clinical trials show a blood oxygen concentration accuracy of < 2%, meeting and exceeding standard medical requirements.

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