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1. 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 User Manual for Fingertip Oximeter 3 Operation 3 1 Directly Measurement 1 Open the clip as shown in Figure 3 RR 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 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 shown as 4B the display will shift to 4C automatically after 20 seconds without operation Press the key again the screen 4 User Manual for Fingertip Oximeter will change another direction as shown in 4D It obviously 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 automa2. soft 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 16 7 Troubleshooting Trouble The SpO2 and Pulse Rate display instable Can not 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 17 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 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 v Pulse rate icon d Low battery voltage SN Serial number 18 User Manual for Fing
3. 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 1 Revised date July 19 2012 All rights reserved 3502 2290049 User Manual for Fingertip Oximeter Warnings 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 Special attention should be paid while the oximeter is used 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
4. any abnormal condition is found please change the position 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 DO NOT clip this device on edema or tender tissue 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 The oximeter is not a treatment device When disposing of the monitor 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 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 e Vigorous exercise and electrosurgical device interference may affect the measuring accuracy Using enamel or other makeup on the nail may affect the accuracy of measurement too long fingernail may cause failure of measurement or Il User Manual for Fingertip Oximeter inaccuracy measurement result Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture Existence of high intensive light sou
5. cessories are subject to change Detailed items and quantity see the Packing List TEINA 6 Repair 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 e 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 e Please take out the batteries if the oximeter will 14 User Manual for Fingertip Oximeter 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 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 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 A High pressure sterilization cannot be used on the device Do not immerse the device in liquid 15 User Manual for Fingertip Oximeter 6 2 Cleaning and Disinfecting Instruction Surface clean sensor with a
6. er the setup menu screen Setup Menu Screen Description SpO alm Lo SpO 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 User Manual for Fingertip Oximeter PR alm Lo Pulse Rate low limit The user can modify the value within 30 60 the step is 1 the default is 50 Pulse beep Pulse beep option If it is set to on every pulse beat makes a beep and the pitch tone of this beep changes according to SpO gt value within 90 99 Save exit menu Long time pressing this item to store settings and 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 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 User Manual for Fingertip Oximeter 3 4 External SpO Probe Connection 1 Connect the external SpO probe to SpO sensor connector in the foll
7. ertip Oximeter B SpO Common Knowledge 1 Meaning of SpO SpO is the saturation percentage of oxygen in the blood so called O2 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 itis 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 HbO 19 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 hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglob
8. g value pathology reason Hypoxemia disease functional lack of HbO Pigmentation or abnormal oxyhemoglobin level lt 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 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 delton hu Web www delton hu www medipek hu 22
9. in 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 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 SpO 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 20 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 hyperkinesias or body temperature decreasing 21 User Manual for Fingertip Oximeter 4 Factors causing low SpO Measurin
10. 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 2x 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 SpOz and PR measurement still meets the specification described above when the modulation amplitude is as low as 0 6 12 User Manual for Fingertip Oximeter 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 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 13 User Manual for Fingertip Oximeter 5 Accessories A lanyard Two batteries A pouch An External SpO gt Probe optional A User Manual Quality Certificate Note The ac
11. owing way Make sure the side with Arrow faces upwards Figure 6 Probe Connection Note when the external SpO probe is connected well the built in finger clip sensor will be disabled The measurement is detected from the external SpO probe 2 The finger should be put in SpO 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 measurement 10 User Manual for Fingertip Oximeter 4 Technical Specifications A Technique dual wavelength LED sensor LED sensor wavelength Red light 663 nanometers Infrared light 890 nanometers Maximal optical output power less than 1 5mW maximum average B SpO measurement Measuring range 70 100 Measuring accuracy Arms is not greater than 3 for SpO range from 70 to 100 Note Arms is defined as root mean square value of deviation according to ISO 9919 SpO gt 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 setting range 11 User Manual for Fingertip Oximeter high limit 100 240bpm default 120bpm low limit 30 60bpm default 50bpm Perfusion Index PI Display Range 0 2 20 Audible amp visual over limit indication When measuring if SpO value or pulse rate value exceeds the preset
12. rces 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 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 iA 1 3 Intended Use 1 4 Structure and Conformation 2 BOT IM 2 2 Battery Installation eere eese esee nete eene teen enaene 3 3 Operation cccccsssessssssssressesesecssesssssssssessesesesesesesees 4 3 1 Directly Measurement css 4 3 2 Over limit indication and Beep Silence T 3 3 Setup Menu Screen 3 4 External SpO Probe Connection 4 Technical Specifications eese 11 5 Accessories EA EEEE EE 14 6 Repair and Maintenance ssssse
13. srsresesesrororeseseseoresesee 14 6 1 Oximeter Maintenance succeer 14 VI User Manual for Fingertip Oximeter 6 2 Cleaning and Disinfecting Instruction 16 7 Troubleshooting eere eere eene ente tnentnnnan 17 Eva c 18 A Key of Symbols B SpO Common Knowledge VII User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Display Key Display Screen Hanging Hole SpO2 sensor connector Figure 1 Front Rear View User Manual for Fingertip Oximeter 1 2 Name and Model Name Fingertip Oximeter Model PC 60N 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 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 SpO probe available Large true color OLED display of SpO PR Pulse Bar PI amp Plethysmogram nnovative 4 directions display Automatic power on off Audible amp visible over limit indication high amp low limits are adjustable User Manual for Fingertip Oximeter Shift parameter display between PR and PI 2AAA alkaline batteries with low power consumption Low battery voltage indication 2 Battery
14. tically shift back to PR as shown in 4C and 4F SpO PR 961 re hhhh P a ld Odss Figure4A Figure4B YVTTY 5 66 a dd Odss iguredD TTY ent Figure4C NNNN amp SpO PI 99 14 SpO PR 99 65 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 9 Pulse beat symbol gt Pulse intensity bar graph PI Perfusion index icon 1 4 Perfusion Index value 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 will 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 silence at the following situations 1 When SpO 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 SpO probe User Manual for Fingertip Oximeter 3 3 Setup Menu Screen SpO alm Lo 85 PR alm Hi 120 PR alm Lo 50 Pulse beep on Save exit menu Restore default Figure 5 Menu Screen Long time pressing display key could ent
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