Instructions to User
Contents
1. 4 pulse rate error is 2 bpm or 2 select the 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 DC 3 6 V 4 2V G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO2 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel alarm indication pulse sound indication battery capacity indication charging indication light SpO2 pulse rate button SpO2 ALM LO pulse bar graph pulse waveform Figure 2 Front View 5 2 Installing the hanging rope A Put the thinner side of the rope through the hole B Put the wider side of the rope through the thinner side which has been put through the hole then tighten it 5 3 Accessories a hanging rope w gt a user manual a power adapter n a data line a disk PC software an oximeter probe optional 6 Operating Guide 6 1 Application method 6 1 1 Measurement A Squeeze the clamp put a finger into the rubber hole then release it B Press the button on the front panel until the device turns on C Donot shake the finger and keep the patient in a stable state during the process D The data can be read directly from the screen in the measuring interface 6 1 2 Lay finger The right m2. 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 Relative Humidity lt 95 8 Troubleshooting 1 Lay the finger properly and try The SpO2 and Pulse 1 The finger is not properly positioned again Rate can not be 2 The patient s SpO2 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 laid inside deep The SpOand Pulse h 1 Lay the finger properly and try enough Rate are not 5 G s shaki de naten again displayed stably Pepe OO AS 2 Let the patient keep calm moving E 1 The batteries are drained or almost 1 Please recharge the battery The device can not drained 2 Please contact the local be turned on 2 The device s malfunction service center 1 This device is set to be automatically power off within 5 seconds when it cannot The display is off tal PaE eee 1 Normal suddenly oe sire ma ae DD 2 Please recharge the battery 2 The battery is drained away or almost drained away The battery can not be full charged even Please contact the local service The battery is broken after 10 hours center charging time 9 Keyof Symbols The pul
3. move the underline to Y then press button to exit the time setting menu and recording will begin If move the underline to N then press button to cancel record and the data stored in memory will not be deleted c If the data storage function is 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 record d Inthe state of record whatever interface the device is in measuring interface menu interface the sign Recording would appear on the screen in 30 seconds then the screen will be automatically shut down If click the button at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if press the button the device would return to the former interface e Ifturning on the data storage function the former saved data will be automatically deleted f When recording the pulse sound indication would be turned off for saving power after the screen is shut down automatically g 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 waming the user if press the button again it will enter the measuring interface Figure 8 E Set Bluetooth state Move the menu selection bar to Bluetooth item then press butto
4. power button to switch to landscape orientation The user can setup the following content in the Settings Menu Backlight Brightness Alarm setting ID setting data storage Record turning on off Bluetooth The specific operation methods are as follows Please note in the Settings Menu CLICK short push of button and PRESS prolonged push of power button 1sec Figure 5 Main Menu Interface A Backlight adjustment In the main menu interface click the button to select Brightness Press the power button and hold to adjust the backlight brightness B Alarm setting In the main menu interface click the power button to select Alarm Press the power button 1sec to enter the alarm setting interface as shown in Figure 6 a Adjusting the high and low limits of alarms Click button to change the position of menu selection bar and press button to set menu item Move the selection bar to Dir and press button to choose value adjusting direction up or down By pressing button operation the user could adjust the value of SpO2 high limit SPO2 ALM HI SpO2 low limit SPO ALM LO Pulse rate high limit PR ALM HD Pulse rate low limit PR ALM LO The alarm low limit can t be beyond the alarm high limit The SpO alarm range is 0 100 the pulse rate alarm range is Obpm 254bpm Air the alarm function is on the device will provide medium priority alarm signal when the measure value is beyond the limit Intermittent alarm will o
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 be u
6. ccur and the measurement shows in yellow Medium priority indicating that prompt operator response is required b The alarm state setting Click the button to select Alarm then press the button to choose alarm on off Choose on to turn on the alarms and off to turn off the alarms Figure 6 Alarm Setting Menu c Pulse sound indication setting Click the button to select Pulse Sound then press button to choose to have the Pulse Sound heart beat on or off d Exit the Alarm settings Click button to select EXIT then Press button to exit the Alarm Settings Menu C ID setting The user could set device ID by software SpO Assistant The user could set character string which could only be made of number or letter and not be beyond 7 bits Y Figure 7 SpO2 Assistant program Ar 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 D Data storage setting This device can record 24 hours data including pulse rate and SpO value accurately and upload the data to the computer for display and analysis a In the main menu interface click button to move the selection bar to Record item then press button to enter the record beginning time setting dialog box as figure 8 b Click button to move the underline to the number that you want to set then press button to set time After setting time
7. ectronic circuits and microprocessor Glow and Infrared ay Emission Tube rN Glow and Infrared ray Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpO gt 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 Automatically power off function when the device is under the state of measuring interface without external probe it will automatically power off within 5 seconds if the finger falls out of probe The display mode can be changed Screen brightness can be changed F G H With pulse rate sound indication I With alarm function J With SpO and pulse rate value record function the record data can be uploaded to computer K It can be connected with an external oximeter probe optional L Data can be observed on computers synchronously by PC software M With two kinds of data transmission mode data line and Bluetooth 4 2 Main Parameters A Measurement of SpO2 Measurement Range 0 100 Accuracy 70 100 2 0 69 unspecified B Measurement of pulse rate Measurement Range 30bpm 250bpm Accuracy 2 bpm or 2 select the larger C Resolution SpO 1 Pulse rate 1bpm D Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is
8. ethod of laying finger is as figure 3 or figure 4 figure 3 Actual probe may be different from the probe as figure 3 please accept the actual probe with the device Figure 4 A Fingernails and the luminescent tube should be in the same side A If the alarm function is on the device will provide medium priority alarm signal when probe or finger is out Intermittent alarm will occur and the user interface presents FINGER OUT Medium priority indicating that prompt operator response is required 6 1 3 Change display mode In the measuring interface you can change the display mode by short pressing the button 6 1 4 Pause alarm A Alarm includes the alarm of measure data s going beyond the limits the alarm of low power and the alarm of finger out B Inthe measuring interface if the alarm function is on during the period of alarming alarm can be suspended by short pressing the button but the function will be renewed in about 60 seconds C Ifyou want to turn off the alarm for good you should enter the menu for operation 6 15 Menu operations In the measuring interface the display direction can be changed by pressing the button with a short push click There are four modes of data display that can be viewed Press the button with a prolonged push 1 second to enter the Settings Menu Interface see Figure 5 Please Note When the display direction is lengthways you can not enter the main menu interface Click the
9. h 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 A 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 40 C 60 C b Relative humidity 5 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 10 C 40 C 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 3 Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp 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 el
10. inger deeply enough into the probe amp 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 optional amp The update period of data is less than 5 seconds which is changeable according to different individual pulse rate amp 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 amp Ifsome abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use amp The device has normal life for three years since the first electrified use amp This device has the function of alarming users can check on this function according to chapter 6 1 as areference amp 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 is on A The device has the function of alarming 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 amp The device may not work for all patients If you are unable to achieve stable readings discontinue use amp Do not contort or drag the connection of the device 2 Overvie
11. lly 6 Please choose the accessories which are appointed or recommended by the manufacturer for avoiding device damage 6 Please choose the battery chargers which should be ensured compliance with the requirements of IEC 60601 1 or else 1t may damage the device 6 Please don t use the device in the course of charging The device can only be matched with the compatible probe optional Please don t measure this device with functional tester for the device s related information 1 3 Hazards A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture amp Tf the oximeter gets wet please stop using it immediately 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 When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly amp When cleaning the device with water the temperature should be lower than 60 C A The fingers which are too thin or too cold may affect the measure accuracy please clip the thicker finger such as thumb or middle f
12. n to turn on off Bluetooth If there is no data transmission the Bluetooth will be closed 5 minutes later A When the data is being transmitted between device and computer the user can t change the state of Bluetooth F Exit the main menu Click button to select EXIT then Press button to exit the Main Menu 6 1 6 PC software operation By PC software the user could upload Real time measure data and storage data Here the user should connect the device to the computer by the USB data line or Bluetooth adapter It is recommended to use the Bluetooth adapter which uses CSR as main chip Please refer to SpO2 Assistant user manual for detailed operation explanation A The user can t use the USB data line or Bluetooth adapter at the same time Please don t pull out the USB data line or Bluetooth adapter when the data is being transmitted between device and computer 6 1 7 Charge There are two kinds of charge method A Connect the device to computer with data line then the device should be in charge state B Connect the device to power supply with power adaptor then the device should be in charge state C When the device is in the state of battery charging the indication light is on when the battery capacity is full the indication light would be off accordingly Au 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 batter
13. ower Adapter Input Voltage 100 to 240 VAC 50 60 Hz Output voltage 5 VDC Output current 250mA Output power Oximeter Probe Wavelength 660nm 880nm Dimensions and Weight Weight About 50g with the lithium battery 1 Appendix Alarm condition delay Alarm signal generation delay
14. r S TO A 4 P IS E O SE AT EET EA EA S A 0 EE EEOAE E S 5 5 1 View of the front panel Saienisi nan a a E a E emt a 5 5 2 Installing the hanging TOPe oiei a a aE a a i a eaaa 5 Md ACC CSSONE Kura a AEAT EE AE N 5 Gs Operating Guide uc a ta a a aaa 6 6 1 Application method 6 6 2 Attention for Operation ida E R EEE 10 6 3 Clinical restctionS or cresiriis riii ci i dean aE EE AEE E A E A aS 10 7 Maintain transportation and StOrage icccccccccccicccccccccccccccccccccccesocesocesocasoceenes 10 Wyle Cleaning and USE O A a a A TE TAE 10 Tas Mamk o 0 dees wd a en EA cane a ag AANER e ooh 200 ange ve EEE TEES 10 7 3 Transportation and stoge nacii iea i ee a EE E E E E a 11 Si Froublesho6tn 3 222 E ir iia 11 92 URC yO SymDOMSe spczsnc5c5e aechsassiiesh outa e ra 11 10 Function Specific diia 12 324 3 0 3 816 b eRe E en A an A ee ee aN 13 III 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 is recommended that the device should be inspected at least once a week Please stop using the oximeter if there is obvious damage to the device lt gt Necessary maintenance must be performed by qualified service engineers ONLY The users are not permitted to service the device by themselves lt gt The oxime
15. se oxygen saturation SpO p yg Full voltage F B arneses e ore e fee a U O menu button power button function button 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank R WEEE 2002 96 EC x Open the pulse sound indication 0 i SN 10 Function Specification Information Display Mode The Pulse Oxygen Saturation Sp0O2 2 digit digital OLED display Pulse Rate bpm 3 digit digital OLED display Pulse Intensity bar graph bar graph OLED display SpO2 Parameter Specification Measuring range 0 100 the resolution is 1 Accuracy 70 100 2 Below 70 unspecified Calculate the Average value in every 4 measure value Average value The deviation between average value and true value does not exceed 1 Pulse Parameter Specification Accuracy 2bpm or 2 select the larger Moving calculate the Average pulse rate every 4 cardio beats cycle Average pulse rate The deviation between average value and true value does not exceed 1 Safety Type Interior Battery BFType Pulse Intensity R Continuous bar graph display the higher display indicate ange e the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 The red wire on the battery denotes anode the black wire on the battery denotes cathode Battery working life Charge and discharge no less than 500 times P
16. sed repeatedly WARNING 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 amp 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 6 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 LS st td te tardado a de 1 1 1 Instructions for safe OPeratiONS ccccccccccccccccccccccccccccccccccnccccsccnccencccecoeeneeen 1 O A ARE ed a 1 13 A 029 tees p E 92032 2A a 5 2 2a E 7 gt aaa stata ctewihdeas dations a TA A A AA RISERS 3 e DO NN 3 2 2 Major applications and scope of applicatiOM oooocccconnnccncnnccccnonnnncnnnnnancnnnnnnnccnnnninccnnnnoss 3 2 3 Environment TOQUEN Sa A ta iaa 3 3 7 Principle niecne aeria da 3 4 Technical specifications eniinn tt tn iii 4 4 1 Man perdon 2822062992522052 EEEO KE REES 4 o PE ER AAA G
17. ter cannot be used together with devices not specified in User s Manual Only the accessory that is 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 in environment with inflammable gas such as some ignitable anesthetic 6 DO NOT use the oximeter while the patient is being scanned by MRI or CT amp DO NOT strand the lanyard in order to avoid device drop and damage The lanyard is made of non sensitive material Please do not use lanyard if the user is allergic to lanyard Do not enwind neck with lanyard in order to avoid accident 6 The disposal of scrap instrument and its accessories and packings 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 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 abnorma
18. w The pulse oxygen saturation is the percentage of HbO2 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 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 low power consumption 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 Operation of the product is simple and convenient B The product is small in volume light in weight and convenient in carrying C Low power consumption 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate throug
19. 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 SpO2 determination by this device may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor resulted in serious error of SpO2 measure D The SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia for some patients with serious anemia may also report good SpO2 measurement 7 Maintain transportation and storage 7 1 Cleaning and disinfecting Using medical alcohol to wipe the device for disinfecting 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 recharge the battery when the screen shows EEN C Recharge the battery soon after the over discharge The device should be recharged every six months when it is no regular used It can extend the battery life following this guidance D The device needs to be calibrated once a year or according to the calibrating program of hospital 10 It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A
20. y icon turns red in the state of flashing High priority indicating that immediate operator response is required 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be in a proper position see the attached illustration of figure 3 and figure 4 for reference or else it may result in inaccurate measure C The ray between luminescent tube and photoelectric receiving tube must get across subject s arteriole D The oximeter should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Ensure nothing such as a plaster can impede the light passage or else it may result in inaccurate measure of SpO and pulse rate F Excessive ambient light may affect measurement accuracy It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Intense activity 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 SpO2 waveform PLETH
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