CREATIVE PC-60NW
Contents
1. 2 Longtime press Display Key to activate the setting item then short time press it to modify the setting parameter 3 Next longtime press Display Key to confirm the modification and exit from this setting item 4 At last move the setting item to Save exit menu and long time pressing Display Key to store the modification and exit from the setup menu 3 4 Data transmission This oximeter has the feature of wireless data transmission the display reading can be transmitted to a computer effectively via the wireless communication function Refer to the manual Oximeter Data Manager for detailed information 10 User Manual for Fingertip Oximeter 4 Technical Specifications A SpO measurement Technique dual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal optical output power lt 1 5mW Measuring range 35 100 Measuring accuracy Ams lt 3 for SpO range from 70 to 100 Note Arms is defined as root mean square value of deviation according to ISO 9919 SpO low limit setting range 85 99 B Pulse Rate measurement Measuring range 30bpm 240bpm Measuring accuracy 2bpm or 2 whichever is greater Pulse Rate limit setting range high limit 100 240bpm low limit 30 60bpm C Perfusion Index PI Display Range 0 2 20 11 User Manual for Fingertip Oximeter Audible amp visual over limit indication When measuring if SpO gt value or pulse ra2. hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO is an important physiological parameter to reflect the respiration and ventilation function so SpO gt monitoring used in treatment has become more popular For example such as monitoring patients with serious respiratory disease patients under anesthesia during operation and premature and neonatal infants The status of SpO2 can be determined in timely manner by measurement and will allow finding the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 19 User Manual for Fingertip Oximeter 3 Factors affecting SpO2 measuring accuracy interference reason 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 Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Exposure to the chamber with High pressure oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel
3. hyperkinesias or body temperature decreasing 20 User Manual for Fingertip Oximeter 4 Factors causing low SpO2 Measuring value pathology reason lt Hypoxemia disease functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough Guidance and manufacturer s declaration The following tables Table 1 to 4 provide the specific information regarding this device s compliance to IEC 60601 1 2 21 User Manual for Fingertip Oximeter Table 1 Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The user of this device should assure that it is used in such an environment Emissions test Compli Electromagnetic ance environment guidance This device uses RF ns energy only for its internal RF emissions Grou function Therefore its RF CISPR 11 P emissions are very low 1 and are not likely to cause any interference in nearby electronic equipment RF emissions A This device is suitable for Class B CISPR 11 use in all establishments Harmonic including domestic and emissions N A those directly connected to IEC 61000 3 2 the public low voltag
4. isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution Then surface clean by soft cloth wet with clean water and let air dry or wipe it dry Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is damaged 15 7 Troubleshooting Trouble The SpO2 and Pulse Rate display instable Cannot turn on the device No display Possible Reason 1 The finger is not placed far enough inside 2 The finger is shaking or the patient 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 The batteries are almost drained 16 User Manual for Fingertip Oximeter Solution 1 Place the finger correctly inside and try again 2 Let the patient keep calm 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center 1 Normal 2 Change batteries User Manual for Fingertip Oximeter No display Please contact the of the Hardware failure local service wireless of wireless center icon VE transmission when it is function enabled Appendix A Key of Symbols Symbol Description A With Type BF applied part A Warning See User Manual SpOr Oxygen saturation percentage PR Pulse rate be
5. User Manual for Fingertip Oximeter Instructions to User Dear Users Thank you very much for purchasing our product Please read the manual very carefully before using this device Failure to follow these instructions can cause measuring abnormality or damage to the oximeter The manual is published in English and we have the ultimate right to explain the Manual No part of this manual may be photocopied reproduced or translated into another language without the prior written consent We reserve the right to improve and amend it at any time without prior notice Version of the Manual Ver 1 0 Revised date October 24 2012 All rights reserved 3502 2290052 User Manual for Fingertip Oximeter Warnings FS Check the device before using it to make sure that there is no visible damage which may affect user s safety or its 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 Special attention should be paid while the oximeter is used constantly under the ambient temperature over 37 C burning hurt may occur because of over heating of the sensor at this situation An uncomfortable or painful feeling may appear if the oximeter is used continuously on the same place for a long time especially for poor microcirculation patients It is recommended that the oximeter should not be applied to the same locatio
6. amb infrared heater or strong sunshine etc may cause inaccuracy of measurement result Please put an opaque cover on the sensor or change the measuring site if necessary If the first reading appears with poor waveform irregular or not smooth then the reading is unlikely true the more stable value is expected by waiting for a while or a restart is needed when necessary IV User Manual for Fingertip Oximeter Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 IEC 60601 1 2 ISO 9919 and follows the provisions of the council directive MDD 93 42 EEC Caution U S federal law restricts this device to sale or use by or on the order of a physician User Manual for Fingertip Oximeter Content 1 Overview 1 1 Appearance 1 2 Name and Model a2 1 3 Intended Use 1 4 Structure and Conformation suc 2 LS Heatres 3025222528 ie ccerecestenessenersecerecccatereaey 2 2 Battery Installation ccsccscssssssssssssssssssessessesseeees 3 3 Operation ccccccsssessssssssrerseseeesssesssssssssessesesesesesesees 4 3 1 Directly Measurement cc 4 3 2 Over limit indication and Beep Silence 8 3 3 Setup Menu Screen 3 4 Data transmission 4 Technical Specifications sssssssssssesesseseseseeees 11 5 ACCOSSOTIES sssseesssscsssssssssescssessesescesesssessesesseses
7. ats per minute vw Pulse rate icon Wireless icon dd Low battery voltage SN Serial number 17 User Manual for Fingertip Oximeter B SpO2 Common Knowledge 1 Meaning of SpO2 SpO gt is the saturation percentage of oxygen in the blood so called O2 concentration in the blood it is defined by the percentage of oxyhemoglobin HbO2 in the total hemoglobin of the arterial blood SpO2 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 2 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 HbO2 18 User Manual for Fingertip Oximeter 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
8. e F power supply network that a fli supplies buildings used for fluctuations flicker N A domestic purposes emissions TEC 61000 3 3 22 User Manual for Fingertip Oximeter Table 2 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The user of this device should assure that it is used in such an environment Immunity IEC 60601 Compli Electromagnetic test test level ance environment level guidance Electrostatic 6 kV 6 kV Floors should be discharge contact contact wood concrete or ESD 48kVair 48 kv ceramic tile If IEC ae hea 61000 4 2 titer the relative humidity should be at least 30 Electrical 2 kV for fast power transient bur supply lines st 1 kV for N A N A TEC61000 4 input output 4 lines Surge 1 kV line IEC s to line s line s to earth 23 Voltage dips short interruptions and voltage variations on power supply input User Manual for Fingertip Oximeter lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles lines 70 UT N A N A IEC 30 dip in 61000 4 11 UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 s Power Power frequency frequency magnetic fields 50 60Hz should be at levels magnetic 3 A 3 Ali characteristic of a fi S ik is typical location in a be typica
9. eers 13 6 Repair and Maintenance ssssscssssssssssssssssssesees 13 6 1 Oximeter Maintenance 0 eee 13 VI User Manual for Fingertip Oximeter 6 2 Cleaning and Disinfecting Instruction 15 7 Troubleshooting cssssssesssscssssessssessssessessesessseees 16 APpendiX viccccsscccseccessssesessesessosessecessecessecessscesescesescosessecs 17 A Key of Symbols B SpO2 Common Knowledge VII User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Figure 1 Front Rear View User Manual for Fingertip Oximeter 1 2 Name and Model Name Fingertip Oximeter Model PC 60NW 1 3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 through patient s finger It is applicable for spot checking SpO gt and pulse rate of adult and pediatric patients in homes and clinics 1 4 Structure and Conformation It consists of main unit and photoelectric sensor 1 5 Features Wireless data transmission can communicate with PC mobile phone PDA Large true color OLED display of SpO2 PR Pulse Bar PI amp Plethysmogram Innovative 4 directions display Automatic power on off Audible amp visible over limit indication high amp low limits are adjustable Shift parameter display between PR and PI 2 User Manual for Fingertip Oximeter 2AAA alkaline batteries with low power consumption Low bat
10. l beep automatically and the value which exceeds limit on the screen will flash The detailed information refers to chapter 4 When the beep sound is activated by over limit it will become silent at the following situations 1 The SpO gt and PR value return to normal range 2 Press Display Key to mute If this over limit event continues the oximeter will resume beeping automatically later in 2 minutes 3 Remove the finger from the oximeter or SpO2 probe User Manual for Fingertip Oximeter 3 3 Setup Menu Screen Wireless on SpO2 alm Lo 85 PR alm Hi 120 PR alm Lo 50 Save exit menu Figure 5 Menu Screen Long time pressing display key could enter the setup menu screen Setup Menu Screen Description Wireless The wireless on off button There are 2 selectable options on and off The device transmits data to PC when it is on SpO alm Lo SpO gt low limit The user can modify the value within 85 99 with 1 as a step PR alm Hi Pulse Rate high limit The user can modify the value within 100 240 with 5 as a step PR alm Lo Pulse Rate low limit The user can User Manual for Fingertip Oximeter modify the value within 30 60 with 1 as a step Save exit menu Longtime pressing this item to store settings and exit to the normal display screen from the setup menu On setup menu screen 1 Short time press Display Key to choose the setting item
11. l commercial TEC61000 4 or hospital 8 environment NOTE UT is the a c mains voltage prior to application of the test level 24 User Manual for Fingertip Oximeter Table 3 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The user of this device should assure that it is used in such an electromagnetic environment Immunity re Compli Electromagnetic test ance test level level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of this device including cables than the recommended Conducte 3 Vrms N A separation distance d RF 150 kHz calculated from the IEC to 80 equation applicable to 61000 4 6 MHz the frequency of the transmitter Recommended separation distance Radiated 3 V m 3 V m RF 80 MHz d 1 2 sP IEC to 2 5 d 12 JP 80MHz10 800 MHz 61000 4 3 GHz d 2 3VP 800 MHzt0 2 5 GHz 25 User Manual for Fingertip Oximeter Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may
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13. n for longer than 2 hours If any abnormal condition is found please change the placing site of oximeter Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion II User Manual for Fingertip Oximeter amp DO NOT clip this device on edema or tender tissue The light the infrared light is invisible emitting from the device is harmful to the eyes so service technician or testee should not stare at the light The oximeter is not a treatment device When disposing of this device and its accessories the local law should be followed Instructions for Operation The finger should be put in properly and correctly Do not shake the finger Keep at ease during measurement e Do not put wet finger directly into sensor e Do not let anything block the emitting light from the device Ensure that there is artery vessel within measuring site where the light transmits through e Vigorous exercise and the interference from the electrosurgical device may affect the measuring accuracy Nail polish may affect the measuring accuracy and too long fingernail may cause failure of measurement or inaccurate result Il User Manual for Fingertip Oximeter Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture Existence of high intensive light sources such as fluorescence light ruby l
14. occur in the vicinity of equipment marked with the following symbol le A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 26 User Manual for Fingertip Oximeter a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating this device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 27 User Manual for Fingertip Oximeter Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of this device can help prevent elect
15. romagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of Rated transmitter maximum m output power 150 kHz to 80 MHz to 800 MHz to of transmitter 80 MHz 800 MHz 2 5 GHz w d 12VP d 12P d 234P 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 28 User Manual for Fingertip Oximeter For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1141 Budapest Fogarasi t 77 1095 Budapest Mester u 34 Tel 220 7940 220 8881 220 7959 Tel 218 5542 215 9771 215 7550 220 7814 364 3428 Fax 220 7940 216 7017 216 7018 Fax 218 5542 Mobil 30 531 5454 30 939 9989 Mobil 30 940 1970 20 949 2688 E mail delton de
16. t the direction of screen is rotated to the left and right side which is accompanied by no waveform displayed as shown in 4B and 4E After 20 seconds without operation the PI will automatically shift back to PR as shown in 4C and 4F Hd 0ds Figure4C i Figure4D gt m gt m O O Q 3 Oo fad LO 2 CT a O Figure4E Figure4F User Manual for Fingertip Oximeter Screen Description Sp02 SpO2 symbol 99 SpO gt value PR Pulse Rate icon 65 Pulse Rate value lt gt HP Pulse beat symbol 4b Pulse intensity bar graph PI Perfusion index icon 1 4 Perfusion Index value GP Wireless symbol Wireless icon f The color of Ya Definition The device is being to establish SYV flashes blue a wireless connection with the surrounding host SV gl long lights blue Successful wireless connection between the device and a host is established User Manual for Fingertip Oximeter No display 6 icon 1 Wireless function is disabled 2 The device fails to setup a wireless connection with the surrounding host within 3 minutes 3 Hardware failure of wireless transmission function while the Wireless function is enabled User Manual for Fingertip Oximeter 3 2 Over limit indication and Beep Silence When measuring if SpO2 value or pulse rate value exceeds the preset alarm limit the device wil
17. tailed items and quantity see the Packing List 6 Repair and Maintenance 6 1 Oximeter Maintenance 13 User Manual for Fingertip Oximeter 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 use of maintenance Please change the batteries when the low voltage indicator lightens Please clean the surface of the oximeter before use Use soft cloth with alcohol to wipe the oximeter first and then let it dry in air or wipe it dry Please take out the batteries if the oximeter will not be used for a long time The recommended storage environment of the device ambient temperature 20 C 60 C relative humidity 10 95 atmospheric pressure 50kPa 107 4kPa The oximeter is calibrated in the factory before sale so there is no need to calibrate it during its life cycle However if it is necessary to verify its precision routinely the user can do the verification by means of SpO gt simulator or it can be done by the local third party test house 14 User Manual for Fingertip Oximeter e Necessary servicing must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves A High pressure sterilization cannot be used on the device Do not immerse the device in liquid 6 2 Cleaning and Disinfecting Instruction Surface clean sensor with a soft cloth by wetting with a solution such as 75
18. te value exceeds the preset limit the device will beep automatically and the value which exceeds limit on the screen will flash The oximeter will shut down automatically in 8 seconds with no signal Display mode Color OLED Display Power supply requirement 2 x LRO3 AAA alkaline batteries Supply voltage 3 0VDC Operating current lt 40mA Environment requirement Operating Temperature 5 40 C Operating Humidity 30 80 Atmospheric pressure 70 106kPa The performance under low perfusion condition The accuracy of SpO2 and PR measurement still meets the specification described above when the pulse modulation amplitude is as low as 0 6 Resistance to interference of surrounding light The difference between the SpO value measured in the condition of indoor natural light and that of darkroom is less than 1 12 User Manual for Fingertip Oximeter Dimensions 60 mm L x 33 mm W x 30 mm H Net Weight 35g including battery Classification The type of protection against electric shock Internally powered equipment The degree of protection against electric shock Type BF applied parts The degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro Magnetic Compatibility Group I Class B 5 Accessories A B C D E A lanyard Two batteries A pouch A User Manual Quality Certificate Note The accessories are subject to change De
19. tery voltage indication 2 Battery Installation Figure 2 Battery Installation 1 Refer to Figure 2 insert two AAA size batteries into the battery compartment properly 2 Replace the cover Please make sure that the batteries are correctly installed since the incorrect installation may cause the device inoperable User Manual for Fingertip Oximeter 3 Operation 3 1 Directly Measurement 1 Open the clip as shown in Figure 3 Tos Figure 3 Put finger into the Oximeter 2 Put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger 3 The device will power on automatically in 2 seconds and start to display software version number 4 Next enter into data display screen as shown in Figure 4 The user can read the values and view the waveform from display screen Shift parameter display between PR and PI during measurement Short time press Display Key the display orientation will rotate 90 degree at the same time PR value shift to PI value automatically and there is no waveform displayed as shown in 4B But if no operation is performed during the first 20 seconds the PI value will change to PR value 4 User Manual for Fingertip Oximeter automatically as shown in figure 4C Press the key again the screen will change its direction as shown in 4D It obviously shows that the alternative display between parameter PR and PI is under the condition tha
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