Pulse Oximeter User Manual
Contents
1. Dual Color LCD with Backlight e Measures SpO amp Pulse Rate e Displays Waveform amp Perfusion Index e Auto On Off Alarm e Low Voltage Indicator e Multi Directional Display 1 5 Important Acronyms e SpO Pulse Oxygen Saturation e BPM Beats Per Minute PR Pulse Rate Pl Perfusion Index 2 Battery Installation Figure 3 Battery Installation Step 1 Refer to Figure 3 Insert two 2 AAA size batteries into the battery compartment Step 2 Slide the battery cover into place Note To ensure the device works properly please make sure the batteries are installed correctly 3 Quick Guide to Operation Step 1 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger Step 2 Wait about 2 seconds the oximeter will power on automatically and start to measure To change the display direction by 180 degrees press the button Display direction change shows bar graph pulse rate symbol and waveform Press the button again to flip the display back see figures 5 amp 7 To shift the displayed readings between PR and PI press and hold the button see figures 6 amp 7 Step 3 Remove your finger the oximeter will power off automatically 4 Display Screen For PC 60D2 oximeter SpO and PR symbols are imprinted on the front panel and its corresponding value displays on display screen below the symbol see figu2. venous infusion Do not let anything block the emitting light from device e Vigorous exercise or strong electro magnetic interference may affect the measuring accuracy e Using enamel or other makeup on the fingernail may affect the accuracy of measurement e If the first reading has irregular or unsmooth waveforms then it is likely inaccurate A more reliable reading may be achieved by waiting for a short period of time or restarting the device 6 Technical Specifications Net Weight 60g including batteries Dimensions 66 mm L x 36 mm W x 33 mm H Power Supply 2 x LR03 AAA Akaline Batteries Transducer Dual wavelength LED sensor Wavelength Red Light 663nm Infrared light 890nm SpO Measurement 35 99 Range SpO Measuring Not greater than 3 for SpO range Accuracy from 70 100 Pulse Rate PR 30bpm 240bpm Measurement Range Pulse Rate Accuracy 2bpm or 2 whichever is greater Perfusion Index PI 0 20 Display Range Operating Temp 5 C to 40 C Operating Humidity 30 to 80 Operating Altitude up to 4 000 meters 1 Accuracy defined as root mean square value of deviation according to ISO 9919 2 Performance Under Low PI Condition The accuracy of the SpO and PR measurement still meet the precision described above when the Pl is as low as 0 6 7 Alarms Preset Alarm Limits SPO alarm Lower limit 90 PR alarm Upper limit 120bpm Lower limit 50bpm Audible amp Visual Alarm
3. 95 atmospheric pressure 50kPa 107 4kPa e The oximeter is calibrated in the factory before sale there is no need to calibrate it during its life cycle However if it is necessary to verify its accuracy routinely the user can conduct the verification by means of a SpO simulator or it can be done by a local third party tester see page 20 1 10 2 Cleaning and Disinfecting Instruction e Surface clean sensor on upper and lower rubber cushions within the finger clip with a soft cloth by wetting with a solution such as 75 isopropyl alcohol then surface clean with a cloth saturated with clean water and dry with a clean soft cloth Caution Do not sterilize by irradiation or steaming method Do not use the device if it is damaged A High pressure sterilization or disinfection cannot be used on the device ZN Do not immerse the device in liquid Z It is recommended that the device should be kept in a dry environment Humidity may reduce the life of the device or even damage it 12 11 Troubleshooting SpO and PR display instable Device will not turn on No display Possible Reason 1 The finger is not placed far enough inside 2 The finger is shaking or the user is moving 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 1 The device will power off automatically when it gets no signal for 8 seconds 2 Th
4. Function During measurement if the SpO value or PR value exceeds the preset alarm limit the device will alarm automatically and the value which exceeds the limit will flash on the screen while the buzzer beeps 8 Classifications Protection against electric shock Internally powered equipment Degree of protection against electric shock Type BF applied parts Degree of protection against harmful entrance of liquids Ordinary equipment without protection against entrance of water Electro Magnetic Compatibility Group Class B 9 Accessories e Lanyard Two 2 AAA batteries e Carrying pouch e User Manual e Quality Certificate Note The accessories are subject to change Detailed items and quantity see the packing list Additional accessories may be purchased by contacting Quest Products Inc at 847 693 2740 or service questproductsinc com 10 10 Repair and Maintenance 10 1 Maintenance The service life not a warranty of this device is 5 years In order to ensure its long service life please pay attention to the maintenance e Change the batteries when the low voltage indicator lights up e Clean the surface of the device before using Wipe the device with wet cloth first and then let it air dry or wipe it dry e Remove the batteries if the oximeter will not be used for a long time e The recommended storage environment of the device Ambient temperature 20 C 60 C relative humidity 10
5. PRODUCTS Pulse Oximeter Portable Monitoring Device User Manual Model PC 60D2 TABLE OF CONTENTS A AAA AA 1 AA Apparao D 1 1 2 Name and Model uusnnsnnsnssnnnnnnnnnnnonnnnnennnnnnnnnnnnnnnnnnnn 2 1 3 Intended Use 1 4 Feature List 1 5 Important Acroynms 2 Battery Installation caai 3 3 Quick Guide to Operation s ssissssssoinsossusninsyannnanusnananinananani 4 4 Display Screen 5 Instructions for Operation 6 Technical Specifications KAN EU AAAA_ A 9 8 Classifications unsensnennnsnnnnennnnennnnnnnnnnnnnnnnnnnnnnnrnnnnnnnnnannn 10 o AP 10 10 Repair and Maintenance 10 1 Maintenance 10 2 Cleaning and Disinfecting nuesensnennnnnnnnnnnnnnnnnnnnn 11 11 Troubleshooting 24 gt 2s 2 44424222240080 52 408002502002 13 O 14 A Key of Symbols B Common Knowledge C Notes D CAU TONS AGA ANUNRINUAANANENGNAG AAA A 19 OVERVIEW 1 1 Appearance Rubber Cushions Display Key AO Display Mia Screen Battery Cover Figure 2 Back View 1 2 Name and Model Name Pulse Oximeter Model PC 60D2 1 3 Intended Use This Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO through user s finger It is solely for use of spot checking the pulse rate and SpO in the environment including exercise high altitude sport and aviation activity 1 4 Feature List
6. at may result from its use Instructions for Safe Operations e Check the device to make sure that there is no visible damage that may affect user s safety or measurement performance with regard to sensors and clips It is recommended that the device should be inspected minimally once a week When there is obvious damage stop using the device Necessary maintenance must be performed only by qualified service technicians Users are not permitted to maintain it by themselves see page 20 e The oximeter cannot be used together with devices not specified in User Manual D Cautions Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee is under MRI or CT scanning 18 E Warnings e An uncomfortable or painful feeling may appear if using the oximeter continuously on the same place for a long time especially for poor microcirculation users lt is recommended that the oximeter should not be applied to the same location for longer than 2 hours If any abnormal condition is found please change the position of oximeter DO NOT clip this device on edema or tender tissue e The light the infrared light is invisible emitted from the device is harmful to the eyes so service technician or testee should not stare at the light e The local law must be followed when disposing of the device Attentions e Keep
7. e batteries are almost drained 13 1 Place the finger correctly inside and try again 2 Calm the user 1 Change batteries 2 Reinstall batteries 3 Contact service provider see page 19 1 Normal 2 Change batteries Appendix A Key of Symbols SpO Pulse oxygen saturation BPWPR Pulse rate beats per minute PI Perfusion Index Pulse intensity bargraph Low battery voltage Date of manufacture With Type BF applied part Warning See User Manual Disposal of this device according to WEEE regulations 14 Appendix B Common Knowledge Meaning of SpO SpO is the saturation percentage of oxygen in the blood so called O concentration in the blood it is defined by the percentage of oxyhemoglobin HbO in the total hemoglobin of the arterial blood SpO is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO HbO HbO Hb x100 HbO are the oxyhemoglobins oxygenized hemoglobin Hb are those hemoglobins which release oxygen Meaning of PI Perfusion Index or PI is the ratio of the pulsatile blood flow to the non pulsatile static blood flow in a patient s peripheral tissue such as finger tip toe or ear lobe Perfusion index is an indication of the pulse strength at the sensor site The Pl s values range from 0 2 for very very weak pulse to 20 for extremely strong pulse The perfusion index
8. rameters to review the reaction of body during physical activity so instant spot checking pulse rate and SpO by an oximeter is a popular solution in any environment including exercise high altitude sport and 16 air travel The medical precondition can be monitored in a timely manner by the measurement of PR 8 Spo it will allow finding the hypoxia status earlier thereby preventing or reducing the risk of occurance of hypoxemia effectively Factors affecting SpO measuring accuracy e Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight e Vascular dyes or external used color up product such as nail enamel or color skin care e Excessive user movement Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line e Exposure to the chamber with High pressure oxygen e There is an arterial occlusion proximal to the sensor e Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 17 Appendix C Notes e The contents contained in this manual are subject to change without notice Information furnished by our company is believed to be accurate and reliable However no responsibility is assumed by us for its use or any infringements of patents or other rights of third parties th
9. re 4 Note the two figures both show that SpO value is 99 and PR value is 86bpm PR Spo ul vefor Figure 4 Figure 5 Note the two figures both show that SpO value is 99 and Pl value is 7 5 PI Spo ul efor Figure 6 Figure 7 Waveform Display The waveform on the pulse oximeter is the plethysmogram which helps to understand if the readings are reliable Normally a smooth and regular waveform would represent good signal quality and therefore a more reliable reading In comparison an unsmooth or irregular waveform would represent poor signal quality with motion artifact and therefore would produce readings that may be inaccurate or unreliable Waveform Meaning NMNN NN NN tiesa als are reliable IN MERE uns inaccurate and unreliable PI Display Perfusion Index PI indicates the bloodflow perfusion under the measuring site and also represents the pulse strength for determination of SpO and PR It is recommended to select a measuring site with a higher PI value such as a fingertip to obtain higher pulse strength The pulse oximeter may reach the declared accuracy while the Pl value is as low as 0 6 5 Instructions for Operation e The finger should be put in properly and correctly e Do not shake the finger Keep at ease during measurement Do not put wet finger directly into sensor e Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during
10. the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture The device should be kept out of the reach of children e If the oximeter gets wet please stop using it and do not resume operation until it is dry When it is carried from a cold environment to a warm and humid environment please do not use it immediately DO NOT operate the button on the front panel with sharp materials 19 DO NOT use high temperature or high pressure steam disinfection on the oximeter Refer to Section 8 for instructions on cleaning and disinfection Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 ISO 9919 For servicing or product related questions please contact Quest Products Inc 191 Ambrogio Drive Gurnee IL 60031 USA Tel 847 693 2740 service questproductsinc com www questproductsinc com 20 YED Quest Products Inc 191 Ambrogio Drive Gurnee IL 60031 USA Tel 847 693 2740 www questproductsinc com
11. varies depending on patients physiological conditions and monitoring sites Because of this variability each patient should establish his own normal perfusion index for a given location and use this for monitoring purposes Pl is also a good indicator of the reliability of the pulse 15 oximeter reading For most pulse oximeters for general use the reading is unreliable or unavailable if Pl is at or below 0 4 Principle of Measurement Based on Lamber Beer law the light absorbance of a given substance is directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpO can be determined SpO measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Practical application of oximeters Pulse Rate and SpO level are important physiological pa
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