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Manual - Maxtec
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1. Equipment classification based on UL 60601 1 EN 60601 1 Protection against electric shock Internally powered Type of applied part BF Not suitability for use in the presence of flammable anaesthetic mixture with air or oxygen or nitrous oxide The instrument is not protected against entry of water Only the cleaning method has been stipulated no disinfection sterilization methods have been stipulated Mode of operation of Equipment Continuous while in Use IEC 60601 1 Appendix Calculation Method for Displayed Values lt Pulse level meter gt The pulse level meter displays the transmitted light amount ratio calculated by the following equation The pulse level is indicated in eight levels 0 to 15 full scale if over 10 Transmitted light amount that varies due to the pulse x 100 Transmitted light amount that does not vary due to the pulse Pulse level lt Oxygen saturation SpO2 gt Updates the moving average of the oxygen saturation over the last 12 seconds at one second intervals lt Pulse rate P R gt Updates the moving average of the last 8 pulse rates at one second intervals 31 xipueddy xipueddy EMC Guidance Guidance and manufacture s declaration electromagnetic emissions The Oxygen Saturation Monitor Model PULSOX 300i is intended for use in the electromagnetic environment specified below The customer or the user of the Model PULSOX 300i should assure that it is used in
2. Voltage dips short Not applicable Interruptions and Voltage variations on power supply Input lines IEC61000 4 11 Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60Hz magnetic should be at level characteristic of a field typical location in a typical commercial IEC61000 4 8 or hospital environment wo N Guidance and manufacture s declaration electromagnetic immunity The Oxygen Saturation Monitor Model PULSOX 300i is intended for use in the electromagnetic environment specified below The customer or the user of the Model PULSOX 300i should assure that it is used in such anenvironment Immunity test IEC 60601 Compliance Electromagnetic environment Test level level guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC61000 4 6 150kHz to 80MHz equipment should be used no closer to any part of the PULSOX 300i than the Radiated RF 3 V m 3 V m recommended separation distance IEC61000 4 3 80MHz to 2 5GHz calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 124P 80MHz to 800MHz d 234P 800MHz to 2 5GHz 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 inmeters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance lev
3. maximum number of storable data has been reached the new data will overwrite the oldest data To keep data be sure to download it before the memory becomes full Accurate measurement data may not be obtained in the fol lowing cases When body movement is excessive When the probe is not attached properly When blood circulation at the measuring point is poor due to pressure on arm finger peripheral circulatory insufficiency When ambient light e g panel light fluorescent light in frared heat lamp direct sunlight is too strong When influenced electromagnetically by other electronic de vices e g near electrical appliances like TV medial device When a mobile telephone is used during measurement When influenced by abnormal hemoglobin like carbon monoxide hemoglobin HbCO and methemoglobin When pigments such as cardiogreen intravascular dyes and indocyanine greenare present in the blood When finger nails are polished piomei04 Tables 1 and 2 below show the errors which may occur due to these hemoglobins Difference from the SaOz2 value to displayed value lt Table 1 gt lt Table 2 gt SaO eee ia 5 10 ENEE ar fas p80 0 2 EA 2 i 2 0 1 5 6 0 9 6 Measured value is always Displayed value is sometimes lower than the actual value higher than the actual value if SaQ2z is around 50 Do not immerse the probe the extension cable or the con necter of PULSOX 300i in disinfectant Doing
4. the PILSOX 300i and the computer refer to the Installation Guide manual of the software e For details regarding the USB Adapter UA 300 refer to the instruction manual of the UA 300 REMATE 21 yoeuu0D xg lt Regarding the display in communication mode gt e When the PULSOX 300i is connected to a computer the PULSOX 300i will enter UA communication mode automatically In UA communication mode the display will appear as shown below This shows the PULSOX 300i is in UA communication mode The instrument is connected to the computer with the UA 300 This shows measured data is being downloaded to the computer Do not remove the UA cable and or USB cable from the PULSOX 300i and or the computer lt Notes on communication mode gt e It is impossible to take measurements while the instrument is in communication mode e When removing the PULSOX 300i from the UA 300 the power of the instrument will be set to OFF automatically 22 Trouble Shootings Error Messages The instrument display error messages when the error occurs Check and correspond to them correctly Error Messages Cause Solution e There is no probe Connect the probe to the warm connected to the PULSOX 300i properly When using N y PULSOX 300i or the the optional Extension Cable U D imen probe is improperly EC 300 connect the cable to the J connected to the instru
5. using the optional the set time after the power measurements software had been turned ON Maintenance and Inspection e Before using the instrument make sure that there is no dam age to the instrument no damage or wire breakage in the probe cable and the instrument operates correctly and safely Cleaning Dampen a soft cloth with neutral detergent or water wipe the instrument with it then wipe off carefully with a dry cloth In this way make sure the instrument is cleaned and never use solvent When cleaning take care not to touch the con nector terminals Touching them may break terminal pins resulting in breakdown or damage 28 Specification E Dual wavelength pulse type 665nm 880nm arterial blood oxygen satura tion measuring instrument Name Oxygen Saturation Monitor Model name PULSOX 300i E Functions Measuring range SpO2 0 to 100 SpO2 Pulse rate 30 to 230 bpm Accuracy SpO2 2 SpO2 70 to 100 range 1S D Pulse rate 2 bpm 30 to 100 range or 2 of value 100 to 230 range 3 PULSOX 300i has been clinically validated for use on adults E Display Display type Liquid crystal display with back light function Oxygen saturation SpO2 Pulse rate number Pulse level meter 8 steps Battery indication 3 steps Error messages indication E Warning functions SpO2 Low SpO2 warning flashing display Battery indication Error message indication E Memory function Up to
6. 04 Instruction manuals PULSOX 300i instruction manual x 1 Separate manual Using manual for Probes x 1 The probe is optional About Probe The following probe types can be used with this instrument Finger Clip Probe SR 5C Spot Check Probe SP 5C e Monitor Probe LM 5C Personal Probe SD 5C As shown in the table below the measuring point varies with the probe used so select the one that is suitable for your purpose Probe type Allowed measuring point iii For the usage method please refer to Connecting the probe page 14 on this manual and the probe s instruction manual piomei04 System Diagrams and Accessories The instrument consists of the following items Standard accessories Optional accessories Optional accessories Finger Clip Probe SR 5C Sb rT dD erent Spot Check Probe SP 5C Cam ID 0 Extension cable EC 300 Cap mj Monitor Probe LM 5C USB adapter UA 300 oper Personal Probe SD 5C Standard accessories Wristband WB 300 AAA size alkaline battery Names of Parts piomei04 Power button Used to start measurement Power ON or end measurement Power OFF S KONICA MINOLTA PULSOX 300xi LCD Display with the backlight function Measurement results and messages are displayed Probe connector Backlight button Connect the probe or Press it to tu
7. 2 where C Hb Concentration of reduced hemoglobin C HbO2 Concentration of oxyhemoglobin The light absorption characteristics of reduced hemoglobin Hb are very different from those of oxyhemoglobin This instrument measures the changes in the absorption of red and infrared lights passing through the tissue to determine the SpO2 of the blood Thus this method is free from the effects of skin color muscles bones and veins E Spectral Absorption of Hb and HbO2 Red light Infrared light E amp 2 E D fe c 2 e fo D a lt T T T 665 700 800 880 900 nm Wavelength 34 Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation SpOz and oxygen partial pressure PaOz is shown in the graph below SpOz is the oxygen saturation as measured by pulse oximeters m Oxygen Saturation vs Oxygen Partial Pressure The curve of the above graph may shift to the right or left according to the pH of the blood or the body temperature Shift to right acidosis high body temperature Shift to left alkalosis low body temperature 35 xipueddy MEMO 36 Manufacturer KONICA MINOLTA SENSING INC 3 91 Daisen nishimachi Sakai ku Sakai shi Osaka 590 8551 Japan 2006 KONICA MINOLTA SENSING INC 9222 1732 26 AGGAKK 1 Printed in Japan
8. 300 hours at one second intervals SpO2 value pulse rate and error message information and the file infor mation file number date and time of starting measurements and duration of measurement Data can be downloaded or displayed using the optional software E Operating conditions Temperature humidity range 0 to 40 C 32 to 104 F 30 to 85 relative humidity with no condensation Atmospheric pressure altitude range 700 to 1060hPa altitude 400 to 3000m E Storage conditions Temperature humidity range 10 to 60 C 14 to 140 F 10 to 95 relative humidity with no condensation Atmospheric pressure altitude range 700 to 1060hPa altitude 400 to 3000m E Power 1 AAA size battery 1 5V 100mW Service life under continual usage approx 30 hours with alkaline battery E Dimensions W xH x D 68 x 58 x 15 mm 7 ke E O D 29 g Q 9 2 Q D E Weight 56g including battery excluding wrist band and probes E Usable life 6 years Verified by KONICA MINOLTA SENSING INC based on own data Probes SR 5C SP 5C LM 5C SD 5C E LED SPD probe Type Finger Clip Probe SR 5C Spot Check Probe SP 5C Monitor Probe LM 5C Personal Probe SD 5C It can be used with one of Extension Cable EC 300 H Components that touch the body Cover Polycarbonate Wrist band Polyethylene terephthalate nylon 6 Rating nameplate Polyethylene terephthalate Wristband Rating nameplate
9. a we KONICA MINOLTA OXYGEN SATURATION MONITOR PULSOX 300i Instruction Manual This instrument must be used according to the instructions of the doctor Safety Symbols Warnings and precautions noted in this manual and the instrument are indicated by the following markings designed to prevent accidents caused by erroneous handling of the equipment This indicates text consisting of a warning or precaution relating to safety Please read the text carefully and use the equipment safely This indicates an action which is prohibited The prohibited action should never be carried out under any circum stances This indicates instructions concerning an action Always follow the instructions carefully This indicates an action which is prohibited Never disassemble the product or unit This symbol indicates that has no alarm function is prescribed in IEC60417 5319 This symbol indicates type BF equipment The instrument provide a particular degree of protection against electric shock particularly the leakage current and reliability of the protective earth connection with an F TYPE APPLIED PART F TYPE APPLIED PART indicates applied part isolated from all other parts of the instrument to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1 1 times the highest rated mains voltage is applied between the ap plied part and earth Pl OOO gt mm a this sy
10. eappears even though the probe is attached properly keep the measuring point as stationary as possible or attach the probe to another part of the body where body movement is relatively low e O blinks e The pulse rate exceeds the upper limit 230 bpm of the measurement range e Measurement cannot be performed when the upper limit of the measurement range is exceeded 25 SJUIOd 49949 SyUIOd 49949 Error Messages Cause Solution e U blinks e The pulse rate belows the lower limit 30 bpm of the measurement range e Measurement cannot be performed when the lower limit of the measurement range is belowed Poa soc e Measurement value blinks The oxygen saturation SpOz is alue below the lower limit 70 of the measurement range The measured value will still be displayed but its accuracy cannot be guaranteed This indicates that the measurement value is out of the guaranteed accuracy range out DE Battery Out e Replace the battery with new one e In this case the measurement data is not left if the battery is removed cas e Battery mark is displayed as level 2 Battery power is low e For about 8 hour s measurement is available e If it is necessary to take measurement over 8 hours remove battery and replace with new one e If the battery is out in the middle of measurement the meas
11. ed however the accuracy of the measurement values cannot be guaranteed e Check that the probe is properly attached to the patient Be sure that the light source and sensor sections are properly lined up If the part being measured is thick insufficient light will be transmitted Attach probe to a thinner part Clean the light source and sensor sections Take measures to prevent direct entry of strong light to the probe If this message reappears even though the above points have been checked the probe may be malfunctioning Use another probe or Zin e P blinks Pulse signal required for measurement is not being received e Check that the probe is properly attached to the patient If the probe is properly attached but this message still appears the circulation in the area being measured may not be good Move the probe to an area from which a sufficiently strong pulse signal can be received If a sufficiently strong pulse signal cannot be obtained regardless of the area to which the probe is attached the probe may be malfunctioning Use another probe e Measurement value and P flash alternately e The pulse is weak and the pulse signals required for the measurement are not obtained The measurement value is displayed however the accuracy of the measurement values cannot be guaranteed e Attach the probe to the body correctly If th
12. el in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ka NOTE 1 At 80MHz and 800Mkz 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 a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone 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 an electromagnetic site survey should be considered If the measured field strength in the location in which the PULSOX 300i is used exceeds the applicable RF compliance level above the PULSOX 300i should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the PULSOX 300i series b Over the frequency range 150kHz to 80MHZz field strengths should be less than 3V m 33 xipueddy Measurement Principle This instrument measures the oxygen saturation SpO2 in arte rial blood and pulse rate continuously in a non invasive method by applying optical principles With this instrument SpOz2 is defined by the following equation C HbO2 SpO2 5 HbO C Hp 100 SpO
13. emble them Doing so may cause explosion or heat generation resulting in fire or injury piomei04 piomei0 4 2200o N CAUTION Failure to adhere to the following points may result in injury or damage to the in strument or other property Do not use batteries other than those specified by KONICA MINOLTA SENSING INC When installing batteries in the instrument make sure that they are correctly oriented according to the 4 mark If alkali fluid from the battery comes in contact with eyes skin or clothing immediately wash the af fected area and see a physician for treatment Do not use probes other than those specified by KONICA MINOLTA SENSING INC Use of alterna tive probes may cause the probe to overheat result ing in burns Do not operate the instrument for long periods of time with a probe attached to a patient Low temperature burn redness or rash may result If you feel pain or itchiness stop use of the instrument im mediately and consult a doctor A doctor should also be consulted before using the instrument on patients with high fever those with peripheral blood circula tion problems or those with sensitive skins When attaching the probe to a patient for use during sleep care must be taken to avoid the cable from becoming twisted around the neck of the patient for instance when he she turns over Contents Safety Symbols Safety Precautions cccccecceeeesseeeesseeeeseeeeeeeeeeeeeeaee
14. eneanes FOTCWONG xcs asd sant cv nriran riain riaa EAEn Er NAE atone Safety Notes 0 0 0 0 cee ceeeseeseeeeeeereeeeee Package Contents ADOUt Probe issaraen System Diagrams and Accessories Names of Parts cceeeeeseeeeeeeerees Notes n USC u cicicincs ic celedesies diandani anaia acne NOteS OM Storage stissiessecesctie insinui iniiaiee Disposal Method eeeceeeeeeeeeeeeeeneeeeees PIOParatiOns usisne nenns noian 1 Attaching the Wrist Band 2 Connecting the probe 3 Installing the battery 0 ee 4 Attaching the PULSOX to the wrist MEASUFEMENE 22 sccicndspceceeneindind cenpeiedceeedendancerenes 1 Starting the Measurement Power ON 2 Reading the display eee eee cece eteee ee teeeeteaee 3 Ending the Measurement Power OFF About Auto Power Off function Regarding the memory fUNCTION e eee ee eee ete reeeeee External Connection zsrsr renen snar n nns Trouble SHOOTINGS eissis a eaves Error Messages iari a ona Check Points before repairing Maintenance and Inspection Clean iaa SPSCHICATION Ea E E E E APPONAIX Greer eereerperrerpeerercrem tere rrerrrreretecerrrrerrrste Calculation Method for Displayed Values 0 eee EMG Guidance st eie os So catereres tna umerette bans eativeenttes cudvadetnase is Measurement Principle csseceeeeeeeeceeeeeeeeeeeeneeeeeeeeeee Relation between Oxygen Saturati
15. f the band outward through band fixture B Take care not to twist the band Fold back and secure the band with the hook and loop tape section When attaching the instrument to an arm adjust the band length and fitting at this hook and loop tape section 13 v i me o o e 7 2 Connecting the probe Connect the probe s connector plug into the Probe Connector on the instrument Make sure that probe s connector plug is oriented correctly Do not connect it in with excessive force Doing so may damage the connector Do not touch the connector terminals by hand Contact failure may occur v oO xe o e 7 lt When using the Extension Cable EC 300 gt Connecting the extension cable EC 300 between the PULSOX 300i and the probe extends the probe cable to a total length of 1m Extension Cable EC 300 1m 14 3 Installing the battery 1 Turn the battery cover clockwise approximately 90 degrees to open the cover When turning the cover keep the flat part of your finger on the cover s catch This facilitates opening the cover with minimum force 2 Insert the battery into the battery compartment according to the polarity mark d shown on the rear of the instrument This instrument requires one AAA size battery v i xe o o e e 7 3 Turn the battery cover counter clockwise approximately 90 deg
16. is message is displayed when the unit is attached to the patient correctly the measurement conditions are regarded as blood circulation or other circulatory problems If this occurs search for a location where adequate pulse signals can be obtained Attach the probe again or warm up the measurement location In particular when the pulse is weak this error tends to occur For improved measurement accuracy if the probe is exposed to strong light wrap it with a piece of black cloth etc Also make sure that the patient rests calmly to avoid influence of body movement 24 Error Messages Cause Solution e The pulse is too strong for e Attach the probe to the body N K SHE e H blinks correct measurement correctly If this message is displayed when the unit is attached to the patient correctly the measurement conditions are regarded as blood circulation or other circulatory problems If this occurs search for a location where more stable pulse signals can be obtained e If this message reappears even though the above points have been checked the probe may be malfunctioning Use another probe ge a8 t e Measurement value A flash alternately and e Motion artifact The measurement value is displayed however the accuracy of the measurement values cannot be guaranteed e Attach the probe to the patient properly If this message still r
17. ks so even if the duration of measurement data is less than 30 minutes it will be treated as a 30 minute block For this reason if measurement data with durations of shorter than 30 minutes are stored the actual measurement duration will be different from the stored duration and the maximum storable time will be shorter than 300 hours The maximum storable number of data files is 399 files After that the No 400 data file will be stored as data file No 1 overwriting the previous No 1 data file External Connection The PULSOX 300i has an external output terminal for outputting measurement data stored in the instrument s memory to a computer In addition when the Data Analyzing Software is installed on the computer and the PULSOX 300i is connected to the computer using UA 300 the date and or Auto power off timer which cannot be set using only the instrument itself can be set It is also possible to download the measured data from the instrument s built in memory to the computer to analyze the data display data graphically save data in spreadsheet format or print data out e For details regarding the Data Analyzing Software refer to the instruction manual and or online help of the software lt Connecting the PULSOX 300i and a computer gt PULSOX 300i UA 300 main unit Computer UA cable USB cable at FT l z C DE F e For details regarding the connection between
18. mbol indicates D C Authorized Standards For North America UL C_ UL gl WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHAN ICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 C US CAN CSAC22 2 No 601 1 For Europe CE Medical Device Directive This instrument complies with EN60601 1 EN60601 1 2 C 0088 EN14971 EN13485 Safety Precautions To ensure correct use of this instrument read the following points carefully and adhere to them After you have read this manual keep it in a safe place where it can be referred to anytime a question arises WARNING Failure to adhere to the following points may result in death or serious injury OOO The instrument is designed for measurement of the ox ygen saturation SpO2 of arterial blood and the pulse rate Do not use it for any other purposes such as warning of sleep apnea and breathing abnormalities Do not use the instrument in places where flamma ble or combustible gases anesthetic gas etc are present Doing so may cause a fire Do not disassemble or modify the instrument and accessories Doing so may cause a fire or electric shock The instrument should not be operated if it is dam aged or smoke or odd smells occur Doing so may result in a fire In such situations turn OFF the pow er immediately remove the battery and contact the nearest authorized service facility Do not put the batteries on a fire short circuit them heat them or disass
19. ment and the probe correctly 7 oN PULSOX 300i e If this message reappears even axe e If using the optional though the probe is properly e C blinks Extension Cable EC 300 connected to the PULSOX 300i the the cable may not be probe is malfunctioning e g wire connected to the breakage inside the probe Use instrument or the probe another probe correctly e The connected probe is e Use a probe that is specifically not for a PULSOX 300i designed for the PULSOX 300i e Insufficient light for e Check that the probe is properly measurement attached to the patient N Y The light emitted from the e Be sure that the light source and y 0 1 LED enters the sensor sensor sections are properly lined directly up L Nb Strong light enters the If the part being measured is thick e L blinks probe s sensor directory insufficient light will be transmitted Attach probe to a thinner part Clean the light source and sensor sections Take measures to prevent direct entry of strong light to the probe If this message reappears even though the above points have been checked the probe may be malfunctioning Use another probe 23 P gt 3 x pe 2 a SIUIOd 49949 Error Messages Cause Solution e Measurement value and L flash alternately l L The light power required for the measurement are not obtained The measurement value is display
20. on and partial Pressure 35 piomei04 Foreword A Safety Notes CAUTION Federal law restricts this device to sale by or on the order of a physician The instrument is designed for measurement of the oxygen saturation SpO2 of arterial blood and the pulse rate Do not use it for any other purposes such as warning of sleep apnea and breathing abnormalities The Oxygen Saturation Monitor PULSOX 300i is designed to measure oxygen saturation SpO2 value in arterial blood and pulse rate by attaching a probe to a peripheral part of the body such as a finger in a non invasive method PULSOX 300i is intended for continuous data collection use such as during a sleep study and not for traditional continuous use The compact lightweight and portable body has a large LCD for easy operation e The LCD has a backlight function providing high visibility even in dark areas Built in memory enables storage of up to 300 hours of measured data Use of the optional software allows you to set the date time and to set the auto power off time on the PULSOX 300i In addition the measured data stored in the memory can be processed stored collectively or output via a printer using a personal computer piomei04 Package Contents Before using the instrument make sure that the following items are present 1 PULSOX 300i main body x 1 2 Wristband WB 300 x 1 3 AAA size alkaline battery x 1 4 piomeai
21. optional soft ware will be reset to the factory setting Jan 1 2000 0 00 if the instrument is left for more than one day without the battery The measurement data and the auto power off time set to the instrument using the optional software will be kept even if the instrument is left without the battery piomei04 10 Disposal Method e When disposing of the used battery insulate the polarity ter minals with insulating tape etc If the terminals of the battery come into contact with metal objects heat generation explo sion or fire may result Make sure that the battery is either disposed of or recycled correctly in accordance with local laws and regulations piomei04 11 qesedaid suol Preparations Before starting measurements using this instrument follow the procedure given below to ensure that measurements are stable S 1 Attaching the Wrist Band Attach the Wrist Band WB 300 supplied as a standard accessory to the instrument Since the WB 300 is made of elastic material it allows for flexibility and comfort of fitting on the wrist 1 Place the instrument Band fixture A with its rear side up hook and loop section 2 Pass the angled tip of the hook and loop tape of the wrist band outward through band fixture A When doing so make sure that the Velcro tape section faces upward 12 Fold up the inserted hook and loop section and stick it firmly to the band Pass the other end o
22. r of the next measurement to appear The measurement data obtained from power ON ee A file number is given to each set start of ees aca of measurement data power ON to up to power OFF end of oower OFF Maximum 399 files measurement will be stored in one file And if the time for Auto Power Off was set in the instrument the setting time is displayed O1 The time for Auto Power Off is set by using the optional software If the time for Auto Power Off has not been set this step will be skipped and the measurement display will appear 6 About 10 seconds after the Power is switched ON measurements will be started and the T measurement data at B 3 ulse level meter is started to 1 second intervals will indicate but the measuring data is be stored in the memory not displayed yet of the PULSOX 300i is displayed until L gr the measuring data is calculated q A The measuring data is calculated and displayed and the measurement is started lt Regarding the measurement data gt The measurement data includes the measurement values SpOz value pulse rate and error message information and the file information file number date and time of start of measurements and duration of measurement 18 2 Reading the display When the instrument is turned ON all the elements of the LCD will light up The pulse level pulse rate and SpOz2 value are displayed during mea
23. rees to close it Introduction of a new SQ mechanism locks the cover automatically when it is closed 4 Attaching the PULSOX to the Wrist d Remove the hook and loop section of the band from the side with no probe connector v iv xe o y e 7 2 Attach PULSOX 300i to the arm by inserting your hand through the Wrist Band 3 Adjust the fastening position of the hook and loop tape to adjust the tension of the Band Measurement 1 Starting the Measurement 1 Connect the probe to the PULSOX 300i correctly 2 Press the Power button for a long time the Power is ON the backlight is ON and all the elements on the display is displayed After 30 seconds since the Power is ON the Backlight is OFF automatically Pulse wave mark will also be displayed in the pulse wave saving mode As shown the right the setting date for today is displayed By default the date time has been set to Jan 1 2000 0 00 and it is displayed in the order of 00 1 1 and 0 00 The correct date time can be set to the instrument using the optional software i Ou co co yu waunse N MLIT oo Oa Display the Year as A D mS Display the Month and the Day J3 month co day m Display the Time as 24 hours format 14 77 hour Hy 5 L minute JUBWSINSeO 4 Next it will cause the file numbe
24. rn ON the extension cable EC 300 to backlight of the LCD this connector External output terminal Connect the optional USB adapter UA 300 to connect the instrument to a personal computer Battery cover The cover can be opened by turning it approximately 90 degrees Wristband Used to set the instrument on your wrist piomei04 Notes on Use This instrument should be used under the following operat ing conditions Temperature of 0 to 40 C 32 to 104 F relative humidity of 30 to 85 with no condensation Atmospheric pressure of 700 to 1060 hPa altitude of 400 to 3000m This is a precision instrument To avoid the possibility of it being damaged the instrument should not be dropped nor should heavy objects be placed on top of it Do not expose this instrument to rain and water This instrument has no alarm function Do not use this in strument if an alarm function is necessary This instrument is designed for use on adults When using the instrument on infants or babies please note that the de signed measurement accuracy cannot be guaranteed Do not use the instrument on a point where there is exces sive vibration In addition to avoid excessive impact on the instrument it should be handled gently Failure to observe this may cause breakdown A maximum of 300 hours of measurement data can be stored or the maximum storable number of data files is 399 files If measurements are continued after the
25. so may cause a malfunction When using the Extension Cable EC 300 fit and secure ca bles so they are not too loose or too tight Before connecting to a personal computer remove the Pulsox from the patient Notes on Storage This instrument should be stored under the following storage conditions Temperature of 10 to 60 C 14 to 140 F relative humid ity of 10 to 95 with no condensation Atmospheric pressure of 700 to 1060 hPa altitude of 400 to 3000m When storing the instrument Do not store the instrument in an area where it will be ex posed to water Do not store the instrument in an area where direct sun light pressure temperature humidity ventilation sunlight dust strong magnetic fields and or saline or sulphurous atmospheres may affect the instrument Do not store the instrument on an inclined surface or on a surface which may be subject to vibrations or physical shock Also avoid vibrations or physical shock during transportation Do not store the instrument in areas where chemicals are stored or where gas may be emitted To avoid any problems occurring the next time the instrument is used make sure the instrument cords probes and other accessories are cleaned and stored safely If the instrument will not be used for more than 2 weeks re move the batteries from the battery to avoid the possibility of Gamage due to leakage of electrolyte The time date set to the instrument using the
26. such anenvironment Voltage fluctuations flicker emissions IEC61000 3 3 Not applicable Emissions test Compliance Electriomagnetic environment guidance RF emissions The Model PULSOX 300i uses RF energy only for CISPR 11 Group 1 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electromagnetic equipment RF emissions The Model PULSOX 300i is suitable for use in all CISPR 11 Class B establishments including domestic establishments r ET and those directly connected to the public armonie emiesions Not applicable low voltage power supply network that supplies IEC61000 3 2 buildings used for domestic purposes Guidance and manufacture s declaration electromagnetic immunity The Oxygen Saturation Monitor Model PULSOX 300i is intended for use in the electromagnetic environment specified below The customer or the user of the Model PULSOX 300i should assure that it is used in such anenvironment Immunity test IEC 60601 Compliance Electromagnetic environment Test level level guidance Electromagnetic 6 kV contact 6 kV contact Floors should be wood concrete or Discharge ESD 8 kV air 8 kV air ceramic tile if fllors are covered with IEC61000 4 2 synthetic materisl the relative humidity should be at least 30 Electrical fast Not applicable Transient burst IEC61000 4 4 Surge Not applicable IEC61000 4 5
27. surement Battery mark Indicates the remaining battery capacity in three steps Pulse rate P R If an error occurs an error message mainly about P R will be displayed Utd Pulse Level Meter Indicate the pulse level A x For stable measurement make sure that the pulse level meter lights up two or more segments by adjusting the measuring point or rubbing or warming it up to improve blood circulation Oxygen saturation SpO2 value If an error occurs an error message mainly about SpOz2 will be displayed 19 JUSLUSINSeO 3 Ending the Measurement Press the Power button for a long time the measurement is finished and the Power is off yu wia nseaN 69 29 KONICA MINOLTA PULSOX 300xi About Auto Power Off function By connecting the instrument to a personal computer and using the optional software the time to be elapsed from power on start of measurement to power off end of measurement can be set as the auto power off timer If an auto power off timer is set the measurement is finished automatically in the time after power on Regarding the memory function 20 The memory built into the PULSOX 300i will continue to hold data even if the battery is removed A maximum of 300 hours of measurement data can be stored e g 10 hours of measurement data can be stored for 30 persons Storage for measurement data is set up in 30 minute bloc
28. urement value is not left is e Battery mark is displayed as level 3 only Battery power is empty e Replace the battery with new one as soon as possible If the battery is out in the middle of measurement the measurement value is not left 26 Error Messages Cause Solution E rr Pal WR te wal DaT e Any trouble may occur in the measurement circuit of the instrument Turn the Power Off and turn ON again If these message reappear even though the above points have been checked the instrument may be malfunctioning Contact to the nearest distributer or authorized service facilities 27 SJUIOd 49949 Q gt 8 x pe Q amp Check Points before repairing Before taking any actions check the following points first If the abnormality continues to reappear the instrument might be faulty so contact the nearest distributor or authorized service facility Problem Checkpoint Solution Ref Page No display Is battery power Turn the Power OFF and P 15 appears when exhausted replace the battery AAA size the Power is with new one turnmediON We22ss sen asses ek a es Is battery oriented Make sure that the battery P 15 correctly are oriented correctly Display Isn t setthe auto If the auto power off timer P 20 disappeared in power off timer by set the Power is turned off in the middle of
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