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Pulse Oximeter Instruction Manual
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1. 199 es 4 Sp j Fig 2 Description of Fig 2 1 Time display in 24 hour format The current time is 17 09 in Fig 2 2t SpOz sensor connected indicator The indicator will not be shown if the sensor is disconnected from the unit 3 10 04 The ID number indicator If you set Display in User ID Set menu on the user ID number will be shown on the top middle of screen refer to Fig 2 Or else it won t be shown refer to Fig 15 4 Beep and alarm i Beep and alarm are off Beep is on while alarm is off Alarm is on while beep is off Battery power indicator See battery life replacement 6 5P92 It is SpOs area of display below the indication t shows the oxygen saturation level of functional hemoglobin during normal measurement The measured SpOz in Fig 2 is 98 The background color of the SpOz2 value shows red when the SpOz is outside the alarm limits It shows two dashes throughout probe off and finger out conditions 7 SpO2 upper alarm limit indicator 8 V1 012 PULSE OPERATOR SMANUAL 8 SpO2 lower alarm limit indicator 9 Pulse amplitude bar It indicates the dynamic pulse amplitude and rate As the detected pulse becomes stronger more bars light with each pulse The reverse is true for weak pulses 10 SpO2 waveform display area It shows the gt waveform during normal measurement It shows Probe
2. iR 8052 10am Pulse Rate Display range 0 254bpm Measurement range 30 235bpm Resolution 1bpm Accuracy 30 99 2bpm 100 235 2 Operation Environment Operating temperature 5 C 40 Relative humidity 5 80 non condensing Atmosphere pressure 86kPa 106kPa Power supply Two AA alkaline batteries Working time work for 30 hours continuously 28 V1 012 PULSE OXIMETER OPERATOR SMANUAL Transport and Storage Environment Storage Temperature 20 C 55 C Relative humidity 10 93 Store and replay Store and replay 72 hours SpO2 and Pulse rate value the time interval is 4 seconds Accessories Standard accessories 1 Two AA batteries 2 One instruction manual 3 One adult finger sensor 50 03 5 Optional accessories 1 Finger sensor for pediatric and infant M 50C04CSO Pediatric 15 45 Kg Infant 3 15 Kg 2 Finger sensor for neonate compatible with BCI Neonate 3kg 3 USB data cable 4 Software CD for data transmission 29 E V1 0l2 PULSE OXIMETER OPERATOR SMANUAL APPENDIX B Declaration Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaratioalectromagnetic The Handheld Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of Handheld Pulse Oximeter should assure that it is used in such an environment IEC i 6060 Electromagn
3. in probe off condition It shows Finger Out in finger out condition 11 PR lower alarm limit indicator 12 PR upper alarm limit indicator Note If you set Display in Alarm Set menu SpO2 upper amp lower alarm limit values and PR upper amp lower alarm limit values will be shown on the screen refer to Fig 2 If you set it off all the alarm limit indicators will not be shown refer to Fig 35 13 PR bpm it is PR area of display below the indication It shows the pulse rate in beats per minute during normal measurement The measured PR in Fig 2 is 68 bpm The background color of the PR value shows red when the PR is outside the alarm limits It shows three dashes throughout probe off and finger out conditions vio PULSE OXIMETER OPERATOR SMANUAL 2 2 Rear Panel Fig 3 2 3 Product Features Compact lightweight design for simple one hand operation lt Color LCD with adjustable backlight display SpOs pulse rate and pulse bar lt Up to 99 patient ID and 72 hour record storage visual amp audio alarm low battery alarm Data transfer to PC for storage or printing Two AA size alkaline batteries Suitable for adult pediatric and neonatal patient Notice To transfer data to PC the oximeter need to be registered As for detailed setup and operation please refer to the MedView instruction manual Transmission software and data cable are not standa
4. not sutanie for use in the presence of a fiammabie anesthetic mature ar or wih emygen or nitrous oxide CHAPTER 2 General Descriptions The handheld pulse oximeter adopts 1 5 inch CSTN screen It can display the SpO pulse rate value and all kinds of parameters such as time ID number pulse bar battery status and so on According to the methods of stenlazaton ar dsinfector V1 012 PULSE OXIMETER OPERATOR SMANUAL 2 1 Front Panel amp Displaying 1 Fig 1 Description of Fig 1 1 Double functional socket for SpO2 probe and data transfer socket Oximeter probe socket Connect the probe with the oximeter before taking a measurement Data transfer socket Connect the oximeter with PC by a USB data cable for transferring data recorded to PC 2 amp the UP button Select the different item and adjust parameters While in adjustment press the UP button repeatedly to increase a parameter by one increment 3 the ENTER OK button Press this button to enter the selected menu or submenu confirm your selection or return to the main menu 40 the POWER button Press this button for about 3s to turn the oximeter on and 4s to turn it off 5 V the DOWN button Select the different item and adjust parameters Press the DOWN button repeatedly to decrease the parameter by one when adjustment 7 V1 012 PULSE OXIMETER OPERATOR SMANUAL 6 Display screen refer to Fig 2 1 1
5. entitled to change guarantee time a Should constitute effective maintenance plan for oximeter and reused supplies This plan includes inspection and clearance and it must comply with the policy of epidemical control unit or health department b Please take out battery before cleaning the oximter c Should make regular clearance Must comply with the policy of epidemical control unit or health department The appearance of oximeter can be cleared by not denuded wet cloth Please use the following permitted solution Ammonia diluted Glutaraldehyde Javel bleacher diluted Mild soap water diluted Please comply with the following regulations to avoid oximeter damage Comply with diluted solution advised by manufacturer all the time Wipe up all clearance solution by dry cloth after clearance all the time Never use such cleanser with wax Never use or spurt any clearance solution on oximeter and permit liquid flow into the back of power supply connector or any air channel in oximeter Never use the following cleanser Any kind of scrub solution or impregnant Acet Ketone Lycine Cleanser with alcohol 23 V1 012 PULSE OXIMETER OPERATOR SMANUAL During operation please note After operation the oximeter you should take off the probe and make daily maintenance If you will not use it for a long time please take out battery e Battery maintenance Please take out battery if you will not use the oximeter f
6. for SpOs measurements Other SpOz sensors may cause improper performance Do not use SpO sensor with exposed optical components Excessive patient movement may cause inaccurate measurements Tissue damage can be caused by incorrect application or use of sensor for example by wrapping the sensor too tightly Inspect the sensor site to ensure skin integrity and correct positioning and adhesion of the sensor More frequently inspection should be taken depend on different patients if necessary Set the upper limit of SpO alarm to 100 means cut off the upper alarm High density of oxygen will cause adverse affection to the neonate So the upper limit of SpO2 alarm must be selected prudently according to the acknowledged clinical practice Inaccurate measurements may be caused by Incorrect sensor application or use Significant levels of dysfunctional hemoglobins such as c arboxyhemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight lt High frequency electro surgical interference and defibrillators lt pulsations Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line lt patient has hypotension severe vasoconstriction se
7. in favor of users operation Warning Indicate that maybe some potential hurt or damage to patients Precaution Make user take a serious attitude toward the incorrect operation which are likely to incur some life threatening incidents Notice Serve as a pivotal notice to avoid preventable incidents during application of this equipment Warnings The handheld pulse oximeter should be confined to sophisticated operator exclusively Prior to application we strongly suggest you should follow instructions listed in this document or any wrong doing operation which causes serious damage will take full responsibility for this Our company will assume no warranty for using this equipment improperly Do not close to liable flammable matters spark in case of unexpected explosion Do not apply this equipment at such environment as magnetic resonance imaging MR or MRI equipment which is the source of some electric noise to influence the accuracy of this equipment and following treatment Make sure to apply this equipment for medial scope and measurement results only serve as a reference for any relevant treatment Please cautiously use this equipment for long time and It is necessary for you to protect yourself from avoidable injury V1 012 PULSE OXIMETER OPERATOR SMANUAL When placing sensor in right place please abide by work instructions strictly for example do not extend tape or fix it too tightly W
8. module and can not be changed by user VISUAL ALARMS If the alarm is activated through over limitation of physiological alarm the background color of corresponding data area will turn red If the alarm is activated by more than one physiological alarm the background color of each parameter will turn red AUDIBLE ALARMS Audible alarms can be heard if there is no silence The audible alarm has different tone pitch and on off beep patterns for each alarm priority High priority Di Di Di Di Di Di Di Di Di Di beeps every 10 seconds Medium priority Di Di Di beeps every 15 seconds Low priority Di beeps every 20 seconds ALARM ACTION Alarms will be activated on following conditions Physiological alarm The alarm will work when the SpOz value or pulse rate beyond the upper limit or goes below the lower limit The background color of corresponding data area turns red The difference is their priority the SpO has the high priority while the pulse rate has the medium Technical alarm The alarm will be sound in case of the finger out or probe off and they are of low priority Warning If an alarm occurs be sure to check patients conditions immediately Check which alarm is going on Check patient s physiological condition Find out the source of the alarm Make the alarm mute if necessary Check the alarm when no warning 20 F vio PULSE OXIMETER OPERATOR SMANUAL 6 2 Sound Setting In
9. or page down by one page Press the ENTER button to return to main menu Settings 1 Alarm Set 2 Set 3 User ID Set 1 amp Sound Set 5 Backlight Set 6 5 Other Information In the main menu press the DOWN button to select the 7 About and press the ENTER button to enter into the screen as the Fig 36 shown You can know the product version and remain storage spare room The oximeter can store 72 hours SpO2 and Pulse rate data at most The time interval is 4 seconds Settings 1 Alarm Set 2 Time Set Settings Alarm Set Time Set User ID Set Sound Set 5 Backlight Set Data Review Exit Fig 35 Note It will turn to the normal measuring screen if there is no operation for 30 seconds 22 V1 012 PULSE OPERATOR SMANUAL CHAPTER 7 Maintenance and Repair WARNING The advanced digital circuit inside the oximeter does not require periodic calibration and maintenance instead of replacing the batteries CAUTION Don t open the cover of oximeter or repair electronic circuits Openning the cover will cause the damage of the device and the annulment of the guarantee 7 1 Maintenance It is very important for user to make daily maintenance of oximeter and parts and it is the important guarantee for our company to perform maintenance service If user did not do according to the below stipulation and lead to oximeter failure and possible health damage our company is
10. 78 23334 1 1667 1 1667 3 6893 3 6893 T 3786 11 6667 116867 23 3334 For transmitters rated at a maximum o utput power not listed above the recommended separation distance d in metres 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 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 33
11. Pulse Oximeter Instruction Ver 1 0 V1 012 PULSE OXIMETER OPERATOR SMANUAL Contents CHAPTER Introduction ere teet erede 3 1 1 Brief Introduction 22 race et ees 3 1 2 Safety Information 3 T 3 Intended Use eost ERE HORAS 6 1 4 Electromagnetic Interference 6 1 5 Equipment Classification 6 CHAPTER 2 General 6 2 1 Front Panel amp 7 2 2 Rear Panel ies ete e dete 10 2 3 Product Features eoe cette dies 10 CHAPTER 3 Install the Batteries and the 11 3 1 Install the 11 3 2 Install the Serisor o epe ep e epISHARERHERRR 12 CHAPTER 4 Setting ID Date and 12 4 1 Date amp Time Setting 13 4 24D Number iie 14 CHAPTER 5 a 15 CHAPTER 6 Other 06 2 2 12 1 17 6 1 Alar
12. ate damage lack of fuel or water labor and capital bother strike and stop working etc 25 V1 012 PULSE OXIMETER OPERATOR SMANUAL b No service offer No service is covered for charges relating to the disassembling refurbishing repackaging and moving the monitor or the part of it The damage caused by the third company not commended by our company to adjust install and replace the parts of the oximeter The damage and failure caused by user or its representative doesn t comply with the operator s manual C The oximeter is installed or connected with such external device without our company permission as printer computer internet line and lead to oximeter failure Our company will charge for the maintenance d Responsibility limitation During the period of maintenance contract validity if user changes the parts manufactured by other manufacturers without our company permission our company is entitled to stop contract 7 4 3 User Guarantee a Please read user manual carefully before operation b Please operate and make daily maintenance as request of manual and guarantee Power supply and environment 7 4 4 No guarantee Principle There is no dispelled smut and not original mark in the crust eThere is physical damage on oximeter and its accessory eThere are liquid leftover and eyewinker on oximeter and lead to short circuit and plugboard failure eAll the probe and accessories belong to consumption and beyond f
13. direction lt Do not dispose of batteries in fire lt If battery fluid should get on your skin or clothing immediately rinse with plenty of clean water lt Remove the batteries from this unit when you are not going to use it for a long period of time approximately three month or more Do not use batteries of a different type together lt Do not use new and used batteries together Dispose of the used batteries according to the applicable local regulations 3 2 Install the Sensor Fig 5 Insert the SpO sensor to the socket refer to Fig 5 Then SpO sensor connected indicator will be shown on the display refer to Fig 2 The indicator will not be shown if the SpO sensor is disconnected from the unit CHAPTER 4 Setting ID Date and Time Always set the date and time before using the unit for the first time Set different ID numbers for different users Check whether the date and time are correct before using the unit reset them if necessary The date and time are important indicators when a measurement is taken T vio2 PULSE OPERATOR SMANUAL 4 1 Date amp Time Setting Set the correct time according to the following steps 1 Long press the POWER button to power on the oximeter and then press the ENTER button to enter into the main menu refer to the fig 6 2 Then press the UP button or the DOWN button to select 2 Time set item and then press the ENTER button to enter into the t
14. e of a healthy person should be more than 96 C Set the SpOz high limit as 90 low limit as 80 d Verify the SpOz visual and auditory alarms the backgroud color of the SpO data should be red and dudu voice should be heard 7 3 Trouble Shooting a Can t power on the oximeter Please check the batteries voltage and try to replace batteries If you confirm that the batteries installed is in good status and the unit can t still power on please contact with local customer service center b Probe OFF alarm Please check whether the probe was connected with the oximeter correctly If the sensor is connected with extension cable please check whether the extension cable is connected with the sensor correctly 7 4 Warranty and Repair 7 4 1 Maintenance Method Maintenance responding time 9 00am 17 30pm Monday to Friday b gt Service support Our company will offer user telephone and e mail technology support and parts change Parts change our company will change parts if it is necessary free of charge in the warranty period Because parts are the sources of maintenance user should send them back to our company if not specified C Update the system software free of charge 7 4 2 Exemption and Limitation Our company isn t responsible for such damage caused by force nature For example fire thunder flash flood cyclone hail earthquake house collapse commotion plane failing and traffic accident deliber
15. etic est leve sval environment guidance 6kV Floors should be wood Immunity test Electrostat ic contact concrete or ceramic tile If discharge B kV air floor are covered with ESD synthetic material the IEC relative humidity should be 610004 atleast 30 30 m V1 0I2 PULSE OXIMETER OPERATOR SMANUAL Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS those are not LIFE SUPPORTING 1 i T sowaztn 00 MHz 55 deg VE Where is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and 4 is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by A electromagnetic site survey should be less than the compliance level in each frequency range Inter ference may occur in the vicinity of equipment marked with the following symbol NOTE1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordiess telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess
16. evels and not indicated for continuous monitoring It can assist the clinician diagnostically by quickly displaying the patient s SpO2 and pulse rate and can additionally store 72 hours of data 1 4 Electromagnetic Interference This oximeter is designed and tested in compliance with the EMC standard complying with the international standard for the EMC of the electronic medical device IEC 60601 1 2 However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the health care and home environments e g cellular phones mobile two way radios electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device This apparatus complies with the IEC 60601 1 2 international standard The requirements of this international standard are CISPR11 GROP1 and CLASS B 1 5 Equipment Classification Clasefication according to 1EC 50601 1 According to the type of protecton ageret Electrical shock According to the degree of protection agernst Electrical shock According to the degree of protection agesnst ingress of water Internet decra poser source equpenant Type equipment rdnary equipment equpment protector ingress of water Non steclizable Use of Uqud surface only Continuous Equinmer
17. hen beginning to measure associated body features please follow the doctor s counseling When link this equipment to other peripherals make sure you are sophisticated operator to handle this device Any peripherals should be in the light of protocol of IEC 950 and IEC 601 1 1 Any input output device should be following the protocol of IEC 601 1 1 Please strictly follow the sensor application instructions considering the sensor is a sensitive device The malfunction of sensor may cause inaccurate data which serve as a foundation to treat patients so please make sure to pay more attention to the sensor and inspect it frequently The worn out data cables may cause inaccurate data and be used as a reference to treat patient so please pay attention to data cable and check it frequently The disposable peripheral should not be repeatedly used Precautions Rinsing the sensors with ethylene oxide solution may have adverse influence on the machine Apart from this the sensor should not be autoclaved or submerged This device is intended for use by persons trained in professional health care The operator must be thoroughly familiar with the information in this manual before using the device Unplug the sensor from the monitor before cleaning or disinfecting to avoid the damage to the device and user Alarm must be set up according to different situation of individual patient Make sure that chime sou
18. ial User will be responsible for such damage caused by bad package during transportation ePlease offer guarantee list and copy of invoice to standby with the period of guarantee ePlease describe failure phenomenon in detail and altogether offer oximeter 7 5 Storage and Transportation Storage Storage Temperature 20 C 55 C Relative Humidity 10 93 Transportation Transport by airline train or vessel after packing according to request Package We pack the product with the hard bag We put the foam between the inner box and the cartoon to alleviate the shake 27 PULSE OXIMETER OPERATOR SMANUAL APPENDIX A Specifications Notes e Specifications may be changed without prior notice e The circuit diagrams the list of components the illustration of diagrams and the detailed rules of calibration are provided exclusively to professional authorized by our company Display Data 5 2 PR pulse column Data update time 12s Others connection status of probe and other alarm information Alarm Alarm 5 and pulse rate value probe off finger out battery exhausted Alarm mode audio alarm visual alarm and information Range SpO 6996 9996 PR 30 235bpm Default values SoO2 Upper 99 lower 90 PR Upper 100 lower 60 SpO 6 Display range 096 9996 Resolution 196 Accuracy 3 7096 9996 Unspecified 0 69 Probe LED Specifications Wavelength Radiant Power 660 2nm 1 8mW
19. ime setting menu refer to Fig 7 Settings Alarm Set Settings 1 Alarm Set 3 User ID Set Sound Set Backlight Set b Data Review 7 About Exit Exit Fig 6 Fig 7 3 Hour setting Press the ENTER button to make the number in the cursor highlight and then press the UP button or the DOWN button to increase or decrease the time refer to the fig 8 After setting the hour press the ENTER button again to make the number in the cursor turns black and then press the UP button or the DOWN button to select other item to set Settings Settings Alarm Set arm Set Al Tune Wo Date 2008 04 28 PULSE OPERATOR SMANUAL 4 Minute setting Press the UP button or the DOWN button to select the minute item and press the ENTER button to make the number highlighted Press the UP button or the DOWN button to change the minute Refer to Fig 10 and Fig 11 Settings Settings Alarm Set 1 Alarm Set Exit Fig 10 Fig 11 According to the Hour setting and the Minute setting you can set the Second the Year the Month and the Day 4 2 ID Number Setting Press the UP button or the DOWN button in the main menu to select the 3 User ID Set Refer to Fig 12 Press the ENTER button you can enter into the ID setting submenu as Fig 13 Press the ENTER button to make the ID number highlighted and then press the UP button or the DOWN butt
20. m Setting ee eee etes 17 6 2 Sound Setting ranna nete a HERR 21 6 3 Backlight Setup epp e ephHRERESPR 21 6 4 Data REVIEW osse ceci sectetuer Messias 22 V1 012 PULSE OXIMETER OPERATOR SMANUAL 6 5 Other 2 2 4 2 1 22 CHAPTER 7 Maintenance and 23 7 1 Maintenance or cerea ed 23 7 2 Calibration and 24 7 3 Trouble Shooting 2 2 1 25 7 4 Warranty and 25 7 5 Storage and 27 APPENDIX A 2 2 28 APPENDIX B Declaration eren 30 CHAPTER 1 Introduction 1 1 Brief Introduction Thank you for purchasing the handheld pulse oximeter The main functions of the device include SpO2 and PR measure visual and audio alarm sensor off alarm data storage and replay etc Please read the operator s manual carefully before using it Note The illustrations used in this manual may differ slightly from the appearance of the actual product 1 2 Safety Information Conception of Warning Precaution and Notice The Warning precaution and Notice in this document are special information
21. nd can be activated when alarm function begin to Work Notices Application of this device may influence the measuring accuracy in the background of electromagnetic areas such as electro surgery environment Operation of this device may be adversely affected in the presence of computed tomography CT equipment Use only the appointed sensors Use of sensors not intended for use with this device may cause inaccurate 4 V1 012 PULSE OXIMETER OPERATOR SMANUAL readings Pay more attention to the application when applying this device under the situation of computed tomography CT environment SpO measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine and fluorescein may adversely affect the accuracy of the SpO reading Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vascular resistance may cause a failure to determine accurate pulse rate and SpO readings Remove fingernail polish or artificial fingernails before applying gt sensors Fingernail polish or artificial fingernails may lead to inaccurate SpO readings SpO average is the number of pulse beats over which the SpO value is averaged pulse average is the number of seconds over which the pulse
22. on to increase or decrease the ID number and finally press the ENTER button to confirm your settings The range of ID number is 1 99 Settings Settings 1 Alarm Set Alarm Set Time Set SE AILT 5 Backhght Set Datu Review 7 About Exit Fig 12 71 V1 012 PULSE OXIMETER OPERATOR SMANUAL If you set Display on the user ID number will be shown on the top middle of screen Or else it won t be indicated refer to Fig 16 Settings c 1 Alarm Set 520 PRm 2 Time Set ALi LA Set User ID ID Set 99 Doy VV an E Fig 15 Fig 16 CHAPTER 5 Take a Measurement After finishing the time and the ID number settings plug your finger into the sensor shown as the following illustration m Fig 16 Placement of the sensor Select the suitable sensor in terms of type and dimension Clip the sensor to the rational position of the patient finger Plug sensor into SpO port on top panel of pulse oximeter Note If the finger is not in the sensor Finger Out will be shown on the bottom of the screen Warnings The measurement would not be performed if the following instances come across in operation Shock Low temperature of hand Have taken vascular activity medicine Anemia carboxyhemoglobin methemoglobin methylene blue Indigo carmine 99999494 V1 012 PULSE OXIMETER OPERATOR SMANUAL Use only SpO sensors provided by the manufacturer
23. or a long time Please charge the battery fully if you will not use it for a long time Please charge over 14 hours at first time or will reduce the battery life If occurs any abnormal phenomena you should stop using immediately and reuse after inspection by a technologist 7 2 Calibration and Verification The performance should be checked every year It should also be checked after every maintenance and repair Required Test Equipment SpOz signal Simulator Note The simulator cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter 7 2 1 Control Key Verification Press Menu key display the history data 7 2 2 Sound Verification a Set the oximeter sound ON b The simulated heart beep sound Can be heard 7 2 3 SpO amp Pulse Rate Measurement Value Verification a Connect SpO Probe to the SpO connector on the oximeter b Insert the operator s finger into the finger sensor the SpO measured value of a healthy person should be from 9596 to 99 and the pulse rate is same as heart rate C If SpO Simulator is available verify the accuracy of Oxygen Saturation Value with probes as follows Oxygen Saturation Tolerance 96 2 86 2 70 3 24 V1 012 PULSE OXIMETER OPERATOR SMANUAL 7 2 4 SpO amp Pulse Rate Alarm Verification a Connect SpO Probe to the SpOs connector on the oximeter b Insert the operator s finger into the finger sensor the SpO measured valu
24. rd accessories Contact your local dealer for purchase m 1 012 PULSE OPERATOR SMANUAL CHAPTER 3 Install the Batteries and the Sensor 3 1 Install the Batteries Description of Fig 4 1 Fixing hole 2 Battery box 3 Battery box cover 4 Clasp 1 Push as direction as indicated by arrow marked and then open the cover with nail 2 Install two batteries lightly as indicated by the polarity sign Note Make sure the polarity of the batteries is correct 3 Make the clasp into fixing hole and push as converse direction as arrow marked until the cover is closed Battery life and replacement There are five shapes of the indicator the centre with 4 bars full 3 bars 2 bars 1 bar empty and the frame in red That the frame of indicator become red means few of battery capacity remains and you should replace the batteries with new ones timely Or else the indicator displays with a red frame constantly until battery capacity reaches critical condition the battery voltage is 2 4V 0 2V at which time the unit shuts down Note Always turn the unit off before replacing the batteries V1 0l2 PULSE OXIMETER OPERATOR SMANUAL Warning If battery fluid should get in your eyes immediately rinse with plenty of clean water And then consult a doctor immediately Cautions lt Do not use batteries not specified for this unit lt Do not insert the batteries with the polarities the wrong
25. ree change range eSuch damage of probe caused by mechanical force doesn t belong to free change range eDuring measurement of SpO principle leads to measure value difficult or inaccurate measurement eMaintenance seal of oximeter are not opened eNot original package lead to oximeter during transportation 26 V1 012 PULSE OPERATOR SMANUAL eNot professional person operation leads to oximeter failure Not our company professionals or authorized personnel disassemble oximeter and lead to oximeter failure eNot carefully read manual and so wrong operation lead to oximeter damage and failure 7 4 5 User s Special Request for Guarantee Time Our guarantee constitution for oximeter complies with electronic product after sale service standard regulated by national laws We regulate the guarantee time of mainboard is one year and all the accessories are three months If users request the guarentee time beyond our regulated guarantee time we should take it into consideration Because electronic product has such character of quick changing for such user asking more than three years guarantee time our company will not buy oximeter parts during maintenance Our company will upgrade oximeter or change new maintenance methods for this we charge the lowest price for new oximeter with user permission 7 4 6 Repackage eTake all the accessories and put them into plastic cover e Try to use original package and packing mater
26. t limits are displayed on the measuring screen refer to fig 26 Settings m ig ex 17 0 Sp0 P Rogn Set Alarm Set SpO2 PR HighLinat 98 100 90 60 90 68 Fig 25 Fig 26 3 Display setup In the Alarm Set submenu you can press the UP button or the DOWN button to select the Display item and then press the ENTER button to highlight the value refer to Fig 27 Press the UP button or the DOWN button to select On Off and then press the ENTER button to confirm the setup If you set Display on 2 upper amp lower alarm limit value and PR upper amp lower alarm limit value will be indicated in screen refer to Fig 2 If you set it off all the alarm limit indicator will not be shown refer to Fig 28 Settings ges 17 BA 2 Time Set 98 100 LowLun 90 60 i Default set Fig 27 Fig 28 In the Alarm Set submenu you can press the UP button or the DOWN button to select the Exit item and then press the ENTER button to return to the main menu V1 012 PULSE OXIMETER OPERATOR SMANUAL ALARM PRIORITY High priority the highest level alarm indicate the patient is in the very dangerous situation Medium priority indicate the warning should be paid attention Low priority indicate the measuring value beyond the preset limitation Alarm functions of the oximeter include technical and physiological alarms All three priorities divided by built in
27. 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 Handheld Pulse Oximeter is used exceeds the applicable RF compliance level above the Handheld Pulse Oximeteshould be observed 31 V1 012 PULSE OXIMETER OPERATOR SMANUAL Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or YSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Handheld Pulse Oximeter The Handheld Pulse Oximeter 18 intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MD300 Handheld Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum cistance between portable and mobile RF communications equipment transmitters and the Handheld Pulse Oximeteras recommended below according to ihe maximum output power of the communications equipment Separation distance according to frequency of Rated transmitter maximum m oulpul 150 kHzto80 80 0 800 800 MHz to power of MHz MHz 2 5 GHz transmitter 3 3 5 wy d d 4 7 71 32 PULSE OXIMETER OPERATOR SMANUAL oner 02334 0360 03689 0 73
28. the main menu press the DOWN button to select 4 Sound set and then press the ENTER button to enter into the sound setup screen refer to Fig 29 and the Fig 30 Settings Settings 1 Alarm Set Alarm Set 2 Time Set Time Set 3 User ID Set m i Sound Set 5 Backlight Set 6 Data Review Alarm Set ore 7 About Exit Exit Fig 29 Fig 30 Press the UP button or the DOWN button to set the sound on or off and then press the Exit button to return to the main menu 0 Beep and alarm are on 2 Beep and alarm are off 2 Beep is on while alarm is off Alarm is on while beep is off 6 3 Backlight Setup In the main menu press the DOWN button to select the 5 Backlight Set and then press the ENTER button to enter into the backlight setup screen Press the UP button or the DOWN button to adjust the brightness There are 5 levels More bars shown means that backlight is brighter And then press the ENTER button to return to the main menu Refer to Fig 31 and Fig 32 Settings Settings 1 Alarm Set Alarm Set 2 Time Set Time Set 3 User ID Set 4 Sound Set 6 Data Review 7 About Exit Fig 31 21 T PULSE OXIMETER OPERATOR SMANUAL 6 4 Data Review In the main menu press the DOWN button to select the 6 Data Review and press the ENTER button to enter into the Data Review screen You can review the measurement records refer to Fig 34 Press the UP button or the DOWN button to page up
29. the value refer to Fig 20 Press the UP button or the DOWN button to adjust the value and then press the ENTER button to finish the setup of SpO2 lower alarm limit The range of lower limit is 69 98 Settings Settings DHT mm L Alarm Set 2 Time Set 2 Tume Set PULSE OXIMETER OPERATOR SMANUAL 2 PR alarm setup In the Alarm Set submenu you can press the UP button or the DOWN button to select the highlimit value below PR item refer to Fig 21 and then press the ENTER button to highlight the value refer to Fig 22 Press the UP button or the DOWN button to adjust the value and then press the ENTER button to finish the setup of PR upper alarm limit The range of upper limit is 31 235 1 Alarm Set Fig 21 Fig 22 In the Alarm Set submenu you can press the UP button or the DOWN button to select the lowlimit value below PR item refer to Fig 23 and then press the ENTER button to highlight the value refer to Fig 24 Press the UP button or the DOWN button to adjust the value and then press the ENTER button to finish the setup of PR lower alarm limit The range of lower limit is 30 234 c ME 2 Set 2 Time Set PULSE OXIMETER OPERATOR SMANUAL 3 Default set In the Alarm Set submenu you can press the UP button or the DOWN button to select the Default set item refer to Fig 25 and then press the ENTER button to confirm the selection synchronously returning to the main menu The defaul
30. value is averaged Hazards arising from software errors have been minimized Hazard analysis conforms to meet 15014971 2000 and EN60601 1 4 1996 Significant levels of dysfunctional hemoglobins such carboxy hemoglobin or methemoglobin will affect of the accuracy of the SpOz measurement Optical cross talk can occur when two or more sensors are located adjoining area It can be eliminated by covering each site with opaque material Optical cross talk may adversely affect the accuracy of the SpO readings Change new batteries in time when the power low indicator appears As the readings will influenced when the power is low Obstructions or dirt on the sensor s red light or detector may cause a sensor failure Make sure there are no obstructions and the sensor is clean For routine equipment maintenance please refer to the service procedures at the associated section as indicated in the manual As to the other concerns for attention please carefully look through the specific chapter in this instruction PULSE OXIMETER OPERATOR SMANUAL 1 3 Intended Use The purpose and function of the handheld pulse oximeter is to indicate measure and display the functional oxygen saturation of arterial hemoglobin SpOz and pulse rate for adults and pediatric patients in hospital ambulatory home and EMS emergency medical service environments The pulse oximeter is intended for spot checking these l
31. vere anemia or hypothermia There is arterial occlusion proximal to the sensor lt patient is in cardiac arrest or is in shock Loss of pulse signal can occur in any of the following situations sensor is too tight There is excessive illumination from light sources such as surgical lamp a bilirubin lamp or sunlight lt Ablood pressure cuff is inflated on the same extremity as the to which SpO sensor is attached Note Pulse sensor should obviate the light source e g radial lamp or infrared lamp 16 V1 012 PULSE OPERATOR SMANUAL CHAPTER 6 Other Settings 6 1 Alarm Setting Press the ENTER button to enter into the main menu and the 1 Alarm Set item is selected automatically and then press the ENTER button to enter into the Alarm Set submenu 1 SpO alarm setup After you enter into the Alarm Set the highlimit value below SpO item is selected automatically refer to Fig 17 and then press the ENTER button to highlight the value refer to Fig 18 Press the UP button or the DOWN button to adjust the value and then press the ENTER button to finish the setup of SpO2 upper alarm limit The range of upper limit is 70 99 Settings 2 Time Set 2 Tune Set 3 T Se Fig 17 Fig 18 In the Alarm Set submenu press the UP button or the DOWN button to select the lowlimit value below SpOz item refer to Fig 19 and then press the ENTER button to highlight
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