Fingertip Finger Pulse Oximeter SPO2 Monitor

FDA & CE APPROVED

Ship Via Hong Kong Airmail

Fingertip Pulse Oximeter, which is authorized by FDA of US { [Premarket Submission Number (510K): K082641] },

CE of Europe and German TUV [(Cert.No. : G1 09 05 50972 011)], has also been approved into ARTG(Australian Register of

 Therapeutic Goods) with the code 136606.

Here shows the URL of Devices and Radiological Health Center of FDA for your consultation:

 www.fda.gov/cdrh/devadvice/;www.fda.gov/cdrh/industry/support/index.html

Operation of the product is simple and convenient

The product is small in volume, light in weight ( total weight is about 54g including batteries ) and convenient  in carrying

Power consumption of the product is low and the two originally-equipped two AAA batteries can be operated

continuously for 30-40 hours.

 Low voltage warning will be indicated in visual window when battery voltage is so low that normal operation

of the Oximeter might be influenced.

The product will automatically be powered off when no signal is in the product for longer than 8 seconds.

The Oximeter is calibrated to display functional oxygen saturation. Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum  Absorption Characteristics of Reductive hemoglobin(R Hb) and Oxyhemoglobin (O2 Hb) in glow and near-infrared zones. Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 940nm near infrared light) can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on OLED display through process in electronic circuits and microprocessor.

Intended Use:

Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in an internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

The oximeter requires no routine calibration or maintenance other than replacement of batteries.

Technical Specifications

Display Type: OLED display

                            SP02 Measurement Range: 70%-100%
                            Accuracy +/-2% on the stage of 70% - 99%
                            Pulse Range Measurement Range: 25 - 250 BPM
                            Accuracy +/-1 BPM or +/-1 % (larger)

Power Requirement:  Two AAA 1.5V alkaline batteries
                           Voltage range:  2.6-3.6V

Low Consumption:  Less than 30mA

Measurement Accuracy:  Sp02 Accuracy +/-2% on the stage of 70% - 99%

                             No definition of less than 70%

                             Pulse rate +/-1BPM or +/-1 % (larger)

Measurement Performance in Low Perfusion Condition:  The pulse wave is available without failure when the
simulation pulse wave amplitude is at 6%

Anti-interference ability of ambient light:  Natural light in indoor lighting and the existing oxygen measurements
under dark conditions with the measured values compared to lessthan 1%.

The product will automatically be powered off when no signal is in the product for longer than 8 seconds.

Dimension Length:  58 mm. Width: 32mm

                      Weight:  54g (including two AAA batteries)

Environment Requirements:  Operation Temperature: 40° F - 104°F

                                                       Storage Temperature:  50° F- 104°F