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AM80 Temp-Pulse Oximeter Page 1 of 12 The normal Arterial Oxygen Saturation (SpO2) range from 93% -99%. The normal human Pulse Rate (PR) range from 60bpm -100bpm. Note: the above ranges can vary from the ages, the regions, and physique conditions of the individuals. What to do if SpO2 lower than 93%? SpO2 down to 93%, which means the subject is in a poor blood oxygenation, the subject could breathe higher level of oxygen than the surrounding air to improve the situation. But note that in the process of increasing oxygen, the index value of SpO2 will keep changing and when the the value is upto 99% and lasts for 5 minutes or more, the subject should breathe normally surrounding air rather than breathing more oxygen, otherwise it may cause "oxygen toxicity" (also known as drunk oxygen) The oxygen that enters the body reacts with oxidase in the cells, can generate hydrogen peroxide, and then turn into Lipofuscin. The Lipofuscin is harmful substances that accelerated cell senescence, and accumulated in Myocardium, make the myocardial cell aging, the ventricular function decreased; The Lipofuscin accumulated in the blood vessel wall, causing blood vessel aging and hardening; The Lipofuscin accumulated in the liver, weaken the function of liver; The Lipofuscin accumulated in the brain, causing mental decline, memory loss, and the subject become dementia; The Lipofuscin accumulated on the skin, forming senile plaques (from baidu encyclopedia). At the same time, excess oxygen will accumulate life aging. Oxygen toxicity symptoms: Sweating, drooling, dizziness, paleness, nausea, vomiting, reduced vision, visual hallucinations, auditory hallucination, olfactory hallucination, mouth odor, numb extremities; In severe case, there will be convulsions, seizures, incontinence phenomenon, even there will be a nerve loss, respiratory arrest. Several groups need daily monitoring of oxygen content: The heart disease patients; heart disease was mainly caused by a lack of myocardial blood flow, blood is the carrier of oxygen and so from this sense myocardial ischemia is the lack of oxygen, if the subject with oxygen insufficiency for a long time that would cause irreversible damage to the myocardium. The chronic disease patients for ages over 60 years old, hypertension, diabetes and asthma groups; The patients of using respirator and oxygen generator; the respiratory system diseases can cause the blood oxygen saturation of the human body decreased, so it is very significance for monitoring the subject who is using respirator, and understanding the subject’s blood oxygen saturation timely to prevent oxygen toxicity. The respiratory diseases patients who have low level of oxygen need to be monitoring their own oxygen content constantly. The snorer; Snoring is caused by airway obstruction, resulting in lack of oxygen, the performance of Page 2 of 12 this group is could not sleep well at night but dozing during daytime and memory decline; Exerciser; Intense exercise will consume body’s lots of oxygen, and anaerobic exercise produces a large amounts of pyruvic acid, lactic acid and other intermediate metabolites can not come out through breathing. After anaerobic exercise will make subject feel exhausted, muscle pain, and may cause out of breath, rapid and abnormal heartbeat, and in severe cases may lead to acidosis and bear the burden of liver and kidney. Pregnant woman; Pregnant women increase oxygen consumption during pregnancy, but oxygen taking ability did not changes or even decreased that result in lacking of oxygen, which may affect the baby’s intelligence and physical ability. Intended Use The PULSE OXIMETER is indicated for non-invasive spot-check measurements of functional arterial oxygen saturation (SpO2) pulse rate and temperature of patient. It can be used in hospital, emergency, transport environments, as well as in the home care environment. Warning z For continuous measurement, please check battery capacity and sensor every two hours; it is recommended to replace the batteries when the battery indicator showed one bar of power left; and the sensor should apply to different finger every 4 hours Function Allocation Table PhotoPart No. SpO2 Pulse Tempera- plethysmo- Rate ture grahic screen Display √ √ AM807 √ √ AM808 √ √ S0188B-S √ √ Storage switch (PPG) AM801 turn Blueto oth serial output interface Accessories Port Connector √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Performance Parameter 9 SpO2 Accuracy: 90% to 100% range: Arms is ±2%; 70%-90% range: Arms is ±3%; <70%: unspecified; 9 Pulse Accuracy: 30-245bpm range: Pulse Accuracy±3bpm 9 Temperature Accuracy: 25℃-45℃ range: temperature accuracy±0.2℃ 9 Power Consumption:Less than 55mA Product Features Comfortable humanized design; Anti-movement algorithm (passed the 16 kind testing model of Fluke INDEX II Simulator); Small size, easy to carry; Innovative and compact design; Suitable for family and medical environment; Page 3 of 12 Maintain good performance during low perfusion (>0.3); Can connect different types of SpO2 and Temp probes; Lower power consumption & automatically power off; Product Appearance 1. Structure Instruction (AM801, AM807, and AM808) Display Direction Shift Button Control Button: Power Switch, Home, Menu Selection Dual-color OLED Display Accessories (SpO2/Temp Probes) Port Connector 2. Color: (Only for AM801, AM807, and AM808) 10 colors available in 2013:Black、Brown、Red、Orange、Yellow、Green、Blue、Purple、Sky Blue、 White; However, from 2014, only top 3 popular colors will be available; Page 4 of 12 3. Product Packaging (Only for AM801, AM807, and AM808); Certificate CE certificate Notes: the registration of Temp-Pulse Oximeter in FDA and CFDA is undertaking. Page 5 of 12 Accessories SpO2 S0162B-L finger clip SpO2 sensor, 1m, Application: S0162D-S silicon soft SpO2 sensor, 0.3m, Application: S0162E-S silicon soft SpO2 sensor, 0.3m, Application: S0162N-L finger clip SpO2 sensor, 0.9m, Application: Adult, Temperature Probes W0024C Reusable skin-surface probe, W0024C Reusable Esophageal probe, 1m W0024E Disposable skin-surface probe, 0.8m W0024F Disposable Esophageal probe, Adapter AM-802 Wrist Adapter AM-802 Way to Wear Wrist Adapter Page 6 of 12 Data Management Software 1. This software is for WINDOS XP system environment; 2. Only applicable to the BIN format file by AM807 stored and by mobile phone stored that through AM808、S0188B-S transferred to the mobile phone; 3. Software interface; Blood oxygen trend; Blood Oxygen (Form); Page 7 of 12 Temperature Trend Chart; Temperature Form; Page 8 of 12 4. Report Template; Blood Oxygen Data Report Template SpO2-PR Report Page 9 of 12 Temperature Data Report Template Page 10 of 12 Devices Comparation Temperature Measurement Function Compared with the Traditional Equipment Models Infrared Ear The Electronic Mercury AM-807, AM-808 thermometer thermometer thermometer Items Continuous and real-time measurement and reading, Advantages beyond the limit Low cost Fast speed Low cost and Features prompt function, wide measuring range, can store and manage data ±0.2℃(35℃-42℃ ±0.2℃(34-42.1 ±0.2℃(35℃-42℃ Range an ±0.2℃(25-45℃) ) ℃) ) Accuracy 5-10 minutes 5-10 minutes 2s 5-10 minutes Speed Automatic Yes Cannot Cannot Cannot Continuous Monitoring Warning Yes No No No Function 32g 9-19g 45g Within 10g Weight IPX2 Yes Yes Yes Waterproof Mouth, Oxter, Mouth, Oxter, Mouth, Oxter, Measurement Auditory Meatus Rectal Rectal Rectal Position Actual Actual/Predictive Actual Actual Measurement measurement measurement measurement measurement Way Display Three digits Three digits Three digits Scale Precision Page 11 of 12 SpO2 Measurement Function Compared with Traditional Temp-Pulse Oximeter Models Traditional Temp-Pulse AM-801, AM807, AM808 Oximeter Items Multi-usage; increasing cost performance; Can see the SpO2, Pulse Rate, Temperature Trend Advantages and history data through the data management Not suitable for family use and Features software; Can generate reports and data statistics. SpO2, Heart Rate, Pulse Display SpO2, Heart Rate, Temperature, Pulse wave wave Parameter SpO2: SpO2: 70%-100%, accuracy: ±3%; Heart rate: 70%-100%,Accuracy:±3%; Range and 25-250, accuracy: ±3BPM; Temperature: Heart rate: 25-250, Accuracy 25-45℃, accuracy: ±0.2℃ Accuracy: ±3BPM IPX2 IPX1 Waterproof Warning Yes No Function Temperature Yes No measurement Extraposition Yes No of SpO2 sensor Extraposition Yes No of Temperature probe Transformation Yes(Except AM801) No direction Yes(Except AM801) No Data save Compatible with data Yes(Except AM801) No management software Note: Product Catalogue available at http://www.med-linket.com/en/ml/en.rar Page 12 of 12