User Manual
Contents
1. Intermittent alarm will occur and the user interface presents FINGER OUT Medium priority indicating that prompt operator response is required FigureS Actual probe may be different with the probe as figure 5 please accept the actual probe with the device B Pause alarm a Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of probe or finger s out of position b When alarm is on press the alarm pause button can pause the alarm it can renew alarm in about 60s and if pressing the alarm pause button again within 60s it can renew alarm 6 c If you want to turn off the alarm for good you should enter the menu for operation C Review Interface a On the measuring interface press up button to enter the Review Interface 1 directly as shown in figure 6 Figure 6 Review Interface 1 b In review interface press menu button to switch between Review Interface 1 and Review Interface 2 press Down button to enter the review interface for next hour or last hour In Review Interface 1 press left button or right button can move the trend graph for storage data When the trend graph cannot be moved any more the sign lt or gt shown under the LCD screen will disappear in Review Interface 2 press left button or right button can move the arrow Press up button to exit the review Interface c In Review Interface 1 the u2. SpO probe of the pulse oximeter in the upper jack The probe is limited to be produced by our company never replace it with the similar ones by other manufacturers AM Please take care when you insert the batteries for the improper insertion may damage the device Mu the alarm function is on the device will provide high priority alarm signal when the battery is in low power status Intermittent alarm will occur and the battery icon turns red in the state of flashing High priority indicating that immediate operator response is required 5 4 Accessories A Dry battery 2AA B A User Manual C A data line D A disk PC software E An adult oximeter probe Model CMS03 An infant oximeter probe May purchase selectively 6 Operating Guide 6 1 Application method A a Put the suitable probe into the jack on the right side of the oximeter The probe is limited to be produced by our company never replace 1t with the similar ones by other manufacturers b Put the finger into the probe Refer to Figure 5 c Press the power on off button long until the device turns on d Do not shake the finger and keep the patient in a stable state during the process e The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be on the same side A If the alarm function is on the device will provide medium priority alarm signal when probe or finger is out
3. When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly A When cleaning the device with water the temperature should be lower than 60 A As to the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enough into the probe A The pulse oximeter can be used to adult or infant Whether the device is used to adult or infant it depends on the probe selected 5 The update period of data is less than 5 seconds which is changeable according to different individual pulse rate L Please read the measured value when the waveform on screen is equably and steady going this measured value is optimal value And the waveform at the moment is the standard one A If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use s This device has the function of alarming users can check on this function according to chapter 6 1 as a reference A The device has the function of limits alarming when the measured data is beyond the highest or lowest limit the device would start alarming automatically on the premise of the alarming function 1s on A The device has the function of alar
4. EL VE Wo AAA ATA A AA 5 53 BATTERY AND PROBE INS TALA TON lada 5 ACE ES OM ains 5 6 OPERAFING GUIDE a a ose 6 G I APPLICATION ME TAO Di A Wencass diver oandalecadesianseolnsaweniassdenwoiniavadias 6 6 2 ATTENTION FOR OPERATION it AAA E AA RARA 11 6 3 CLINICAL RESTRICTIONS A aaa eee 12 7 MAINTAIN TRANSPORTATION AND STORAGE ccccccccocccccoccccccccccoocccoooccoooccooeoceuos 12 PA CLEANING AND DIS IN FECTING Secucatvanc iii cirio iia ici 12 O 12 Td TRANSPORTATION AND STORAGE dio 12 TROUBEESHOO TIN Gun ai aaa Eaa e a a a 13 97 KEY OE SYMBOLS ui tia 13 10 FUNCTION SPECIFICATION cuide 14 II APPENDIX 1 MI 1 Safety 1 1 Instructions for safe operations lt gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers It 1s recommended that the device should be inspected once a week at least When there 1s obvious damage stop using the device lt gt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves lt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device lt gt This product is calibrated before leaving factory 1 2 Warning Explosive hazard DO NOT use the oximeter
5. Instructions to User Dear users thank you very much for purchasing the Pulse Oximeter This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The Manual describes in accordance with the Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed strictly Failure to follow the User Manual may cause measuring abnormality equipment damage and human injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality human injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty service does not cover such faults Owing to the forthcoming renovation the specific products you received may not be totally in accordance with the description of this User Manual We would sincerely regret for that This product is medical device which can
6. ain menu interface press the up button or down button to select Alarm then press the left button or right button to enter the alarm setting menu of figure 10 Figure 10 Alarm Setting Menu a The highest lowest alarm limit setting Press the up button or down button to choose the parameter to be adjusted then press the left button or right button to change data Each press of the left button or right button the data will raise or descend for one time accordingly Au the alarm function is on the device will provide medium priority alarm signal when the data of SpO or pulse rate is beyond the limit Intermittent alarm will occur and the measurement shows in yellow Medium priority indicating that prompt operator response is required b The alarm state setting Press the up button or down button to select Alarm then choose the alarm state on off by pressing the left button or right button choose on to turn on the alarms and choose off to turn off the alarms for good c Exit the Alarm settings Press the menu button to exit the Alarm Settings Menu b Pulse sound indication setting On the main menu interface press the up button or down button to select Pulse Sound then Press the left button Or right button to choose to have the Pulse Sound heart beat on or off c Backlight adjustment On the main menu interface press th
7. ation and storage 7 1 Cleaning and Disinfecting Using medical alcohol to disinfect the device nature dry or clean it with clean soft cloth 7 2 Maintain A Please clean and disinfect the device before using according to the User Manual 7 1 B Please change the battery when the screen show si C Take out the battery if leave the equipment unused for a long time D The device needs to be calibrated once a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A The packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Humidity lt 95 12 8 Troubleshooting 1 Place the finger properly and The SpO and Pulse 1 The finger is not properly positioned try again Rate can not be 2 The patient s SpO is too low to be 2 Try again Go to a hospital for displayed normally detected a diagnosis if you are sure the device works all right 1 The finger is not placed inside deep The SpQ and Pulse h 1 Place the finger properly and enough Rate are not j j j j try again 2 The finger is shaking or the patient is displayed stably 2 Let the patient k
8. be used repeatedly WARNING 6 Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 2 hours For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light Testee can not use enamel or other makeup amp Testee s fingernail can not be too long 6 Please refer to the correlative literature about the clinical restrictions and caution 6 This device is not intended for treatment The User Manual is published by our company All rights reserved Contents A TY 2279 252 4A E Ae A A A NNa 1 LI INSTRUCTIONS TOR SAFE OPERATIONS an 1 1 22 WARNING A O 1 O A o 3424272772 RASA A 1 2 OVERVIEW ni ii 2 Deli FEATURES a ii aa 2 2 2 MAJOR APPLICATIONS AND SCOPE OF APPLICATION cccccssesssssecccccseeessseeccccsecessesceceseeessesesesceeeas 2 2 3 ENVIRONMENT REQUIREMENTS iia 3 3 O ST O 3 4 TECHNICAL SPECIFICATIONS OA doce aa 3 A V MAIN PERFORMANCE o soucasanass 3 4 2 MAIN PARAMETERS lilas EE 4 Be INSTALLATION sirios Fe eE AIR TADA IR IR RARE 4 Shc VIENTOS THE FRONT PANEL unto pisas 4 5 2 UNDERSIDE VIEW AND LEF
9. e up button or down button to select Brightness then press the left button or right button to change the number in order to adjust the brightness of screen d Data storage setting This device has the function of 24 hours data storage It can store the measured pulse rate data and SpO data accurately transfer the data to the computer display the data and print reports with the included SpO Software Green Heart a On the main menu interface press the up button or down button to select Record then press the left button or right button again to enter the dialog box of figure 11 or finger 12 1f it 1s not in recording state will come into figure 11 if it is in recording state will come into figure 12 Le Are you sure Yes Figure 11 b In the status shown in Figure 11 press left button or right button can change the setting of the item then press menu button to exit the status in Figure 11 and perform setting YES for starting recording NO for do not recording c In the status shown in Figurel2 press left button or right button can change the setting press menu button will exit the Figure12 and perform setting YES for stopping recording NO for continue recording Figure 12 d If the data storage function is being turned on when return to the measuring interface a red REC sign and a flashing red dot would appear on screen which means the device is in a state of st
10. e would return to the main menu directly h Exit the main menu On the main menu interface press the menu button to exit the main menu E PC software operation Please connect the device with computer by the USB data line or Bluetooth adapter please ensure the Bluetooth is on if the data is transmitted by Bluetooth then double click SpO2 Assistant icon to run the PC software The functions such as uploading data and change device ID could be carried out by the software Please refer to lt SpO Assistant user manual gt for details Au the users choose to turn on the synchronizing display function on computer it would probably take several seconds for the data to appear on the computer screen If there is no data on the computer screen unplug USB data line or Bluetooth adapter then repeat step E again 6 2 Attention for operation A Please check the device before using and confirm that 1t can work normally B The finger should be in a proper position see the attached illustration of figure 5 for reference or else it may result in inaccurate measure C The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between 11 D The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Do not fix the SpO sensor with barrier such as adhesive or else it may resu
11. eep calm moving 1 The battery is drained away or almost 3 Please change batteries The device can not drained away 4 Please install the battery again be turned on 2 The battery is installed incorrectly 3 Please contact the local service 3 The malfunction of the device center The display is off The battery is drained away or almost l Please change batteries suddenly drained away 9 Key of Symbols Signal Description Warning See User Manual The pulse oxygen saturation _ 8 Close the alarm sound indication H Pause the alarm sound indication _ D Open the alarm sound indication Close the pulse sound indication Open the pulse sound indication 13 The battery power is full gt i The lack of battery power Please change batteries in time for exact measuring Power on off button left button Alarm pause button Menu button Right button Type BF x 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank WEEE 2002 96 EC 10 Function Specification Information e Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display Pulse Rate PR 3 digit digital OLED display 14 Pulse Intensity bar graph bar graph OLED display 0 100 the resolution is 1 Calculate the Average value in every 4 measure value The deviation between average
12. in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom is less than 1 F Power supply requirement DC3V G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel probe jack Bluetooth 2 pulse ound indication alarm indication ls battery status indication Spol ALM HI pulse rate 5p0 lt pulse bar graph 5p01 ALM LO pulsas ma velon power oniof button menu button up button bet batiam gh button alarm pame ha itan down button USB 5 2 Underside View and Left View E ba Figure 3 Underside View and Left View 1 Probe jack It is used to connect a SpO sensor to measure the oxygen saturation and pulse rate 2 USB port It is used to connect a personal computer to export the trend data via a data line 5 3 Battery and probe installation A Refer to Figure 4 and insert the two AA size batteries properly in the right direction 08050004 Figure 4 batteries installation B Replace the cover C Inserting the
13. in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee measured by MRI and CT The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packing including battery plastic bags foams and paper boxes should follow the local laws and regulations Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device The device can only be matched with the compatible probe 6 Please don t measure this device with functional tester for the device s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A Ifthe oximeter gets wet please stop operating it A When it is carried from cold environment to warm or humid environment please do not use it immediately A DO NOT operate keys on front panel with sharp materials A High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection A Do not have the oximeter immerged in liquid
14. ing transmitted between device and computer when the data is being transmitted between device and computer the user can t set Bluetooth If the user can t set Bluetooth after cutting connecting please try again after waiting 30 seconds f Device ID The user could modify device ID by software SpO gt Assistant 10 g Clock setting On the main menu interface press the up button or down button to select Clock then enter the clock setting interface by Press the left button or right button Figure14 clock setting interface a When entering the clock setting menu the menu choice bar would be on the item of set time and the state would always be no whenever it enters the clock setting menu on the purpose of avoiding unexpected changes of time due to improper operation You can change the state by press the left button or right button choose yes to reset the time choose no to forbid time resetting b Press the up button or down button to select the parameter that you want to change then adjust the data by press the left button or right button c Exit the clock setting menu directly by press the menu button If you have reset the time or date when exiting the clock setting menu firstly the renewed time and date would be displayed on the screen then it returns to the main menu if you didn t reset the time and date when exiting the clock setting menu the devic
15. lt in inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup I Please clean and disinfect the device after operating according to the User Manual 7 1 6 3 Clinical restrictions A As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference B For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor resulted in serious error of SpO measure D As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO measurement 7 Maintain transport
16. ming this function can either be paused or closed default setting for good This function could be turned on through menu operation if you need Please check the chapter 6 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpO in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO gt is of great help for the doctor to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter features in small volume convenient operation and being portable It is only necessary for patients to put one of his fingers into a probe for diagnosis and a display screen will directly show the measured value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Opera
17. mp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ay Emission Tube Glow and Infrared ray Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpO value display B Pulse rate value display bar graph display C Pulse waveform display D Low voltage indication low voltage indicator appears before working abnormally which is due to low voltage E Screen brightness can be changed F A pulse sound indication G With alarm function H With storage function of SpO value and pulse rate value the stored data can be uploaded to computers I It can be connected with an external oximeter probe J Real time data can be transmitted to computers K Review function L Clock function M Wireless transmission function 4 2 Main Parameters A Measurement of SpO Measuring range 0 100 Accuracy When the SpO measuring range is 70 100 the permission of absolute error is 2 Below 70 unspecified B Measurement of pulse rate Measuring range 30bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution SpO 1 Pulse rate 1bpm D Measurement Performance
18. oring e In the state of storing whatever interfaces the device is on measuring interface menu interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down If pressing any button power on off excluded at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if pressing the power on off button the device would return to the former interface f If turning on the data storage function the former data storage will be automatically removed g In the state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power h When the storage space is full it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user if press any button power on off excluded again it will enter the measuring interface In the main menu interface press the up button or down button to move the menu choice bar to Bluetooth then press the menu button to turn on off Bluetooth Choose on to turn on Bluetooth and choose off to turn off Bluetooth as figure 13 A It is recommended to use the Bluetooth adapter which use CSR as main chip Please don t to pull out the USB data line or Bluetooth adapter when the data is be
19. ser can observe the trend waveform composed by storage data each screen can show storage data for 114 seconds the yellow line shows the SpO trend waveform the red line shows the PR trend waveform the time underside shows the starting time of displaying the date in the screen the middle and underside the screen means the operation direction of the Down button Press right button 1t will show in the position then press Down button to enter next hour Press left button 1t will show in the position then press Down button to enter last hour d The Review Interface 2 shown based on Review Interface 1 the stored SpO value and PR value in each second can be observed here the underside date from left to right marks time SpO value PR value When the stored data exceeds the upper and lower limit setted by user the relevant value will turn green Figure 7 Review Interface 2 D clock interface On the measuring interface press the right button can enter the clock interface of figure 8 Press the right button again can return to the measuring interface 10 09 Figure 8 Clock interface E Menu operations On the measuring interface press the menu button can enter the menu of figure 9 Users can adjust the settings through the main menu such as alarm pulse sound indication backlight data storage data transmission the specific method is as follows a Alarm setting On the m
20. tion of the product is simple and convenient B The product is small in volume light in weight and convenient in carrying 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger The product is suitable for being used in family hospital oxygen bar community healthcare physical care in sports It can be used before or after doing sports and it is not recommended to use the device during the process of having sport and etc The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide the device is not recommended to be used under this circumstance 2 3 Environment requirements Storage Environment a Temperature 40L 60 b Relative humidity 5 95 c Atmospheric pressure SOOhPa 1060hPa Operating Environment a Temperature 10 40 b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO gt in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning a
21. value and true value does not exceed 1 Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 _ cardio beats cycle Average pulse rate The deviation between average value and true value 1 does not exceed 1 Safety Type e Interior Battery BFType Pulse Intensity Continuous bar graph display the higher display indicates the stronger pulse Battery Requirement Dry batteryQAA Oximeter Probe Wavelength 660nm 880nm Wireless Module Transmit frequency About 180g with Dry battery 2AA 15 Appendix 1 Alarm condition delay Alarm signal generation delay 16
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