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FDA Approved Medical Use Fingertip Pulse Oximeter Waveform Parameter

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FDA Approved Medical Use Fingertip Pulse Oximeter Waveform Parameter

Country/Region china
City & Province suzhou jiangsu
Categories Camera Chargers
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Product Details

FDA Approved Medical Use Fingertip Pulse Oximeter

 

【Fingertip Pulse Oximeter Description】

 

Fingertip Pulse Oximeter provides a simple, fast, and reliable way to measure oxygen saturation level (SpO2) as well as pulse (heart rate).

 

Display Type
Dual Color OLED Display
Measurement Range
Spo2: 35%-99%
Pulse Rate(PR): 30BPM-240BPM
Measurement Time≤20S
Resolution
Spo2: ±1%
Pulse Rate(PR): ±1BPM
Accuracy±1%(90%-99%) ; ±2% (70%-89%); unspecified(≤70%) for Spo2
Low Perfusion
≤0.4%
Power
Two of 1.5(AAA Size) Alkaline Batteries
Power Consumption
<30mA
Automatic Power-off
The product will automatically power off when no signals for 8s.
Operation Environment
Operation Temperature: 5℃~40℃
Humidity: 30%~90%
Air Pressure: 59KPa~107.4KPa
Dimension58*36*32mm
Net Weight33g (Batteries Not Included)
Package1 Unit/Box, 200 Boxes/Ctn
Carton Size36.5*42.5*35.5cm
G.W./Carton15KGS
Standards
IEC 60601-1-2:2014, ISO 80601-2-61:2011
CertificatesCFDA, FSC, ISO13485 & CE (TUV), DOC, FDA
Warranty1 Year

 

【Fingertip Pulse Oximeter Structure & Dimension】

 

 

【Fingertip Pulse Oximeter Features】

 

 

【Fingertip Pulse Oximeter Application】

 

 

【Fingertip Pulse Oximeter Package】

 

 

【Fingertip Pulse Oximeter FAQ】

 

Q1: What is normal for pulse oximeter reading?
A1: Values under 60 mm Hg usually indicate the need for supplemental oxygen.

Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.

 

Q2: Is this Fingertip Pulse Oximeter freely selling in European markets?
A2: Yes. Our Fingertip Pulse Oximeter is approved by both CE & ISO (issused by TUV).

Fully complied with Medical Directive 93/42/EEC.

 

Q3: Are free samples available before official mass purchasing?
A3: We can support you free samples, and you just need to bear the courier charge.

 

Q4: Why there are so many BLOODY CHEAP OXIMETERS with price less than $4, $3 or even less than $2 per piece?

A4: Well, you need the ability to identify the difference bewteen a Electronic Grade Oximeters and a Medical Grade Oximeter.

 

First of all, the executivce standards for the electronic one and the medical one are way different.

You can judge it from the certificates and test reports that sent by your suppliers, pay attention to the testing standards,

issuing parties of the certifications, for those points you can refer to A2.

For American market, pls check the manufacturer's information in US FDA website to check its FDA registration status and

FDA510K.

 

Second, the oximeters are mainly used in hospitals and emergency rooms by the doctors or physicians, so the reading must

be accurate, onsidering the safety and stability, it is strongly recommended to use a Medical Grade Oximeter.

 

At last, the price is decided by it production cost like raw materials, displaying way(LCD, LED, OLED etc.),

and intelligent designs (alarming, rotation etc.).

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