Creative PC-60N, Instructions For Use Manual

Page 1: ... 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 1 Revised date July 19 2012 All ri...

Page 2: ...ed continuously under the ambient temperature exceeds 37 burning hurt may occur because of over heating on the sensor An uncomfortable or painful feeling may appear if using the oximeter 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 location for longer than 2 hours If any abnormal c...

Page 3: ...for Operation The finger should be put in properly and correctly Do not shake the finger Keep at ease during measurement Do not put wet finger directly into sensor Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion Do not let anything block the emitting light from device Vigorous exercise and electrosurgical device interf...

Page 4: ...ive light sources such as fluorescence light ruby lamb 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 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 ne...

Page 5: ...acturer 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 ...

Page 6: ... Structure and Conformation 2 1 5 Features 2 2 Battery Installation 3 3 Operation 4 3 1 Directly Measurement 4 3 2 Over limit indication and Beep Silence 7 3 3 Setup Menu Screen 8 3 4 External SpO2 Probe Connection 10 4 Technical Specifications 11 5 Accessories 14 6 Repair and Maintenance 14 6 1 Oximeter Maintenance 14 ...

Page 7: ...User Manual for Fingertip Oximeter VII 6 2 Cleaning and Disinfecting Instruction 16 7 Troubleshooting 17 Appendix 18 A Key of Symbols 18 B SpO2 Common Knowledge 19 ...

Page 8: ...User Manual for Fingertip Oximeter 1 1 Overview 1 1 Appearance Figure 1 Front Rear View ...

Page 9: ...e for spot checking SpO2 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 and additional data upload connector 1 5 Features External pediatric SpO2 probe available Large true color OLED display of SpO2 PR Pulse Bar PI Plethysmogram Innovative 4 directions display Automatic power on off Audible visib...

Page 10: ...onsumption Low battery voltage indication 2 Battery Installation Figure 2 Battery Installation 1 Refer to Figure2 insert two AAA size batteries into the battery compartment properly 2 Replace the cover Please make sure that the batteries are correctly installed or incorrect installation may cause the device not to work ...

Page 11: ... seconds and start to display software version number 4 Next enter into data display screen as shown in Figure 4 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 is shifted to PI value automatically as shown in 4B When s...

Page 12: ...y shows that shifting parameter between PR and PI is under the condition of the display orientation rotating to a side 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 Figure4A Figure4B Figure4C Figure4D Figure4E Figure4F ...

Page 13: ...al for Fingertip Oximeter 6 Screen Description SpO2 SpO2 symbol 99 SpO2 value PR Pulse Rate icon 65 Pulse Rate value Pulse beat symbol Pulse intensity bar graph PI Perfusion index icon 1 4 Perfusion Index value ...

Page 14: ...ch 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 silence at the following situations 1 When SpO2 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 ...

Page 15: ...ssing display key could enter the setup menu screen Setup Menu Screen Description SpO2 alm Lo SpO2 lower limit The user can modify the value within 85 99 the step is 1 the default is 90 PR alm Hi Pulse Rate high limit The user can modify the value within 100 240 the step is 5 the default is 120 ...

Page 16: ...nd exit from the setup menu to the normal display screen Restore default Restore default setting Refer to Figure 5 for each default value On setup menu screen 1 Short time press Display Key to choose the setting item 2 Longtime press Display Key to active 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...

Page 17: ...e 6 Probe Connection Note when the external SpO2 probe is connected well the built in finger clip sensor will be disabled The measurement is detected from the external SpO2 probe 2 The finger should be put in SpO2 probe properly and correctly 3 The oximeter will power on automatically 2 seconds later then display software version number 4 Other operation is similar to chapter 3 1 directly measurem...

Page 18: ...less than 1 5mW maximum average B SpO2 measurement Measuring range 70 100 Measuring accuracy Arms is not greater than 3 for SpO2 range from 70 to 100 Note Arms is defined as root mean square value of deviation according to ISO 9919 SpO2 low limit setting range 85 99 default 90 C Pulse Rate measurement Measuring range 30bpm 240bpm Measuring accuracy 2bpm or 2 whichever is greater Pulse Rate limit s...

Page 19: ...imit on the screen will flash The oximeter will shut down automatically in 8 seconds with no signal F Display mode Color OLED Display G Power supply requirement 2 x LR03 AAA alkaline batteries Supply voltage 3 0VDC Operating current 40mA H Environment requirement Operating Temperature 5 40 C Operating Humidity 30 80 Atmospheric pressure 70 106kPa I The performance under low perfusion condition The...

Page 20: ...han 1 K Dimensions 60 mm L 33 mm W 30 mm H Net Weight 35g including battery L 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 ...

Page 21: ...pair and Maintenance 6 1 Oximeter 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 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 wip...

Page 22: ... sale 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 SpO2 simulator or it can be done by the local third party test house Necessary servicing must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves High pressure sterilization cannot be...

Page 23: ...cloth by wetting with a solution such as 75 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 ...

Page 24: ...r correctly inside and try again 2 Let the patient keep calm Can not turn on the device 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center No display 1 The device will power off automatically when it gets no signal for 8 seconds 2 The batteries are ...

Page 25: ...p Oximeter 18 Appendix A Key of Symbols Symbol Description With Type BF applied part Warning See User Manual SpO2 The pulse oxygen saturation PR Pulse rate beats per minute Pulse rate icon Low battery voltage SN Serial number ...

Page 26: ...alculated by the following method SpO2 HbO2 HbO2 Hb 100 HbO2 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 af...

Page 27: ...ured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO2 is an important physiological parameter to reflect the respiration and ventilation function so SpO2 monitoring used in treatment has become more popular For example such as monitoring patients with serious respiratory disease patients under anesthesia during o...

Page 28: ...nfrared 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 p...

Page 29: ...xemia 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 ...