Berry Bm2000A CE FDA Apnea Screening Wrist Pulse Oximeter

• Customization: Available
• Classification: Physiological Functions of Diagnosis and Monitoring Equipment
• Type: Patient Monitor
• Model NO.: BM2000A
• Certification: CE, FDA, ISO13485
• Color: Blue
• Experience: with 11 Years Manufacturer
• R&D Department: Excellent Engineers and Technicians
• Quality: ISO13485 CE TUV 0123
• Delivery Time: 7-10 Days
• Place of Origin: Shanghai, China (Mainland)
• After-Sales: Yes
• Samples: Available
• OEM: Available
• Applications: Hospitals, Clinics, Family
• Transport Package: Box Packing
• Specification: CE
• Trademark: Berry
• Origin: Shanghai, China
• HS Code: 9018191000
• Production Capacity: 5000 PCS/Month

Product Description

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.

Widely Used In Daily Life
BM2000A applies to Aviation,Snorer,Child,Asthma,COPD

Major Features
1.Equipment is suitable for sleep or Apnea respiratory monitoring, especially Apnea and hypopnea monitoring.
2.Through contrast experiments with PSG, it can be used for the diagnosis of clinical sleep apnea syndrome. 
3.Product is low power consumption, The 3.7V lithium battery can last for more than 20 hours.
4.The equipment has approved international CE, 510K, and other certifications.
5.Various types of sensors, which are suitable for infants and children adults and people of different ages and people of different skin colors. 
6.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
1,Download the BerrySmartHealth APP from Google Play and Apple Store.
2,Wear the equipment to keep at least 6 hours sleep monitoring.
3,Put on the device and wrap foam spO2 sensor around fingertip.
4,The collected data is transferred to the mobile phone via bluetooth.
5,Display report on phone.
6,Reports can be shared.


Technical Features

Display SpO2, PR	Battery Type: 3.7v (1000mAh) Rechargeable Lithium Batteries
Pulse Rate: Measurement range: 25 - 250bpm Accuracy: ±2bpm	SpO2: Measurement range: 35% - 100% Accuracy: ±2% (80% - 100%) ; ±3% (70% - 79%)
Size:68(L)x58(W)x20(D)mm	Weight: 50g
Working Voltage: DC 3.4v ~ DC 4.3v	Free App: "BerrySmartHealth"

Accuracy Test

Blood Oxygen Concentration Tes                                                                      Pulse Rate Test               

                                                                                                            Berry Product Rate VS Reference heart rate ECG

                                                                                                            Correlation=0.98, P-value< 0.0001

                              Average reference oximeter                                                                       Reference Heart Rate(ECG)                           

                                            Effective (SaO2)                                                                                            (ECG) [BPM]

Comparison: Reference Pulse Oximeter
Berry Pulse Oximeter	70 ~ 100	90 ~ 100	80 - < 90	67 - < 80	RESE≤3% Within the range of 70~100%
# pts	240	79	81	81
Error	-0.6	-1.1	-0.9	0.1	Pass
Root mean square error	1.9	1.7	2.0	2.1

 

Berry products have passed the accuracy test, blood oxygen

concentration accuracy <2%,510k requirements<3%

 

Parameter Comparison Chart

Apnea Trend

Hypopnea Trend

Software Advantage

  Blood Oxygen Results                                       Mean Blood Oxygen Results

Diagnosis Of Hypoxemia                                        OSAHS Diagnosis        

PSG vs. ROC Curve

 

Analysis Of Clinical Trial Results

Mean Blood Oxygen
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
1,Adult probe
2,Child probe
3,Neonate probe
4,Gift box
5,User manual

 

Reports can be shared.

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