用 户 须 知 - Medipek
Contents
1. Solution Please shake the oximeter with a certain force to make the movable metal ball move freely If the problem still exists maybe the orientation sensor is not working properly Please contact the local service center 1 Place the finger correctly inside and try again 2 Let the patient keep calm Can not turn on the device No display No display of the wireless icon Y5 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 Hardware failure of wireless transmission function 19 User Manual for Fingertip Oximeter 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center 1 Normal 2 Change batteries Please contact the local service center 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 hd Pulse rate icon Wireless icon d Low battery voltage SN Serial number 20 User Manual for Fingertip Oximeter B SpO Common Knowledge 1 Meaning of SpO2 SpO gt is the saturation percentage of oxygen in the blood so called O2. Hole SpO2 sensor connector Figure 1 Front Rear View User Manual for Fingertip Oximeter 1 2 Name and Model Name Fingertip Oximeter Model PC 6ONW 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 and additional data upload connector 1 5 Features Wireless data transmission can communicate with PC mobile phone PDA External pediatric SpO probe available Large true color OLED display of SpO2 PR Pulse Bar PI amp Plethysmogram e Automatic change display direction Automatic power on off User Manual for Fingertip Oximeter e Audible amp visible over limit indication Pulse beep with pitch tone pulse beep on off and high amp low limits can be set via setup menu Shift parameter display between PR and PI 2AAA alkaline batteries with low power consumption 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 User Manual for Fin
3. 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 D 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 24
4. 2 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 21 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 hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO is an important physiological parameter
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 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Version of the Manual Ver 1 1 Revised date July 19 2012 All rights reserved 3502 2290047 User Manual for Fingertip Oximeter Warnings FS 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 senso
6. acy Ams is not greater than 3 for SpO gt 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 high limit 100 240bpm default 120bpm 12 User Manual for Fingertip Oximeter low limit 30 60bpm default 50bpm Perfusion Index PI Display Range 0 2 20 Audible amp visual over limit indication When measuring if SpO2 value or pulse rate 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 SpOz and PR measurement still meets the specification described above when the modulation amplitude is as low as 0 6 13 User Manual for Fingertip Oximeter Resistance to interference of surrounding light The difference between the SpO gt value measured in the condition of indoor natural light and tha
7. gertip Oximeter 3 Operation 3 1 Directly measurement 1 Open the clip as shown in Figure 3 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 SpO0 PR SpO Pli v 99 651 99 14 I hatha hea hhhh Figure4A Figure4B User Manual for Fingertip Oximeter Screen Description SpO SpO2 symbol 99 SpO gt value PR Pulse Rate icon 65 Pulse Rate value lt gt PP Pulse beat symbol P Pulse intensity bar graph PI Perfusion index icon 1 4 Perfusion Index value P Wireless symbol Change display direction Tilt the oximeter to change display direction It is better for user to read value conveniently Shift parameter display between PR and PI during measurement Short time press Display Key to shift the 4A and 4B When shown as 4B the display will shift 4A automatically after 20 seconds without operation User Manual for Fingertip Oximeter Wireless icon f The color oi oY am Definition GF displays gray Wireless function is disabled The device fails to se
8. he 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 SpOz probe to SpO sensor connector in the following 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 SpO2 probe 2 The finger should be put in SpOz 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 3 5 Data transmission This oximeter has the function of wireless data transmission The user could effectively transmit the data to computer through the wireless communication module Refer to the Oximeter Data Manager for detailed information 11 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 accur
9. heric 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 gt simulator or it can be done by the local third party test house e Necessary servicing must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves High pressure sterilization cannot be used on the device A Do not immerse the device in liquid 16 User Manual for Fingertip Oximeter 6 2 Cleaning and Disinfecting Instruction Surface clean sensor with a 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 17 7 Troubleshooting Trouble Display direction doesn t change or changes insensitively The SpO2 and Pulse Rate display instable Possible Reason Maybe the oximeter is not used for a long time the movable metal ball within the orientation sensor can not move freely 1 The finger is not placed far enough inside 2 The finger is shaking or the patient is moving 18 User Manual for Fingertip Oximeter
10. orientation sensor for detecting the orientation of Il User Manual for Fingertip Oximeter the oximeter When you want to change the oximeter s display direction if you move the oximeter too slowly the movable metal ball will also move slowly because of not enough acceleration Consequently the response of orientation detection would be delayed Please move the oximeter with a bit of force if you want to change the display direction such as bend extend your finger quickly so an acceleration is provided to the orientation sensor for quick sensing the orientation change Using enamel or other makeup on the nail may affect the accuracy of measurement too long fingernail may casue failure of measurement or unaccuracy measurement result 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 lamb infrared heater or strong sunshire etc may cause unaccuracy 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 IV User Manual for Fingertip Oximeter unlikely true the more stable value is expected by waiting for a while or a restart is needed when necessary Note Due to the working principle of orientation sensor used in oximeter there is a small me
11. r 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 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 amp 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 e 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 venous infusion e Do not let anything block the emitting light from device e Vigorous exercise and electrosurgical device interference may affect the measuring accuracy The orientation sensor works on the basis of the gravity A small movable metal ball is built in the
12. ss on SpOz2 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 enter the setup menu screen Setup Menu screen description Wireless the wireless on off button Transmitting data to PC when it is on on and off can be optional The factory default is on SpO gt alm Lo SpOz low limit 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 User Manual for Fingertip Oximeter default is 120 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 SpO2 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 Long time press Display Key to active the setting item then short time press it to modify the setting parameter 3 Next long time press Display Key to confirm t
13. t 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 1 Class B 14 User Manual for Fingertip Oximeter 5 Accessories A lanyard Two batteries A pouch An External SpO gt Probe optional A User Manual Quality Certificate Installation CD optional Note The accessories are subject to change Detailed items and quantity see the Packing List QAmMMOUAw gt 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 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 15 User Manual for Fingertip Oximeter 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 atmosp
14. tal ball which is movable within its compartment of the orientation sensor Therefore you can hear a slight clatter sound when you wave or shake the oximeter It is normal and not caused by unwanted part User Manual for Fingertip Oximeter Content L OVEINIOW catenins 1 PV APPCab ame ii iaae 1 1 2 Name and Model scenerne 2 1 3 Intended Use suser 2 1 4 Structure and Conformation 0 s 0000000000000e 2 1 5 Feat Tres eiei iiie eae EEE EEEE EREEREER 2 2 Battery Installation sssesesesossssesssossssesessssssesesessese 3 3 Operation cccccsssesssssssssessesesesesesesssssssessesesesesesesees 4 3 1 Directly measurement suc 4 3 2 Over limit indication and beep silence 7 3 3 Setup Menu Screen scenerne 8 3 4 External SpO Probe Connection 10 3 5 Data transmission suc 11 4 Technical Specifications ssssssssssssesessesesesssees 12 SLA CCESSOTIES sxassasccesassivsvsssacsaisaiscississississisinnnass 15 6 Repair and Maintenance cssccsssssssssssssesssseeees 15 VI User Manual for Fingertip Oximeter 6 1 Oximeter Maintenance secure 15 6 2 Cleaning and Disinfecting Instruction 17 7 Troubleshooting csssssesssssssssssssscsssssssssessessseers 18 JaN Ti D EEEE 20 A Key of Symbols lt sisisisnssresesersoscreeeeeeereesereeeeereeseseeci 20 B SpO2 Common Knowledge 21 VII User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Hanging
15. 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 22 User Manual for Fingertip Oximeter 3 Factors affecting SpO2 measuring accuracy interference reason lt 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 23 User Manual for Fingertip Oximeter 4 Factors causing low SpO2 Measuring value pathology reason Hypoxemia disease functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level lt Abnormal
16. tup a wireless connection with the surrounding host P flashes blue The device is being to establish a wireless connection with the surrounding host oT long lights blue Successful wireless connection between the device and a host is established No display icon Hardware failure of wireless transmission function User Manual for Fingertip Oximeter When the device fails to try establishing wireless connection within 3 minutes the icon Ge will become gray and the Wireless function is disabled automatically You have to enable it next time manually Notes Notes The pulse beep has the pitch tone feature when SpO gt value is higher than 90 that means the beeping tone changes according to the SpO gt value 3 2 Over limit indication and beep silence When measuring if SpO2 value or pulse rate value exceeds the preset 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 sound 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 Wirele
Download Pdf Manuals
Related Search