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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.
than 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 look at the light source. Testee can not use enamel or other makeup. Testee’s fingernail can not be too long. Please refer to the correlative literature about the clinical restrictions and caution.
1.1 Instructions for safe operations ......................................................1 1.2 Warning .........................................................................................1 1.3 Attention ........................................................................................2 2 Overview..............................................................................................4 2.1 Features..........................................................................................4 2.
1 Safety 1.1 Instructions for safe operations 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. It is recommended that the device should be inspected weekly at least. When there is obvious damage, stop using the device. Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by themselves.
Please don't measure this device with functional tester for the device's related information. 1.3 Attention ֠ Keep the oximeter away from dust, vibration, corrosive substances, tinder, high temperature and moisture. ֠ If the oximeter gets wet, please stop operation. ֠ When it is carried from cold environment to warm or humid environment, please do not use it immediately. ֠ DO NOT operate button on front panel with sharp things.
֠ If some abnormal conditions appear on the screen during test process, pull the finger out and reinsert to restore normal use. ֠ The device has normal life for three years since the first electrified use. ֠ The device has alarm function, this function can either be paused, or closed (default setting) for good.Please check the chapter 6.1 as reference. ֠ The device has the function of beyond limit alarm.
2 Overview The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration.
The Pulse Oximeter can be used in measuring the pulse oxygen saturation, pulse rate and perfusion index through finger.The product is fit for 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.
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 (HbO2) in glow & near-infrared zones.
4 Technical specifications 4.1 Main performance SpO2 value display Pulse rate value display, bar graph display Pulse waveform display Perfusion Index value display Charge function: Lithium battery is the power supply and can be charged up time and again. Low-power indication: low-power indication symbol appears before working abnormally which is due to low-power. Power-off :long press power button to turn off the device. The display direction can be changed.
C Perfusion Index Range: 0%~20% D Resolution SpO2 : 1%, Pulse rate: 1bpm; Perfusion Index:0.1% E Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%; pulse rate error is ±2 bpm or ±2% (select larger). F 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%. G Power Supply Requirement: 3.6 V DC~4.
Figure 2 Front View 5.2 Probe installation A. Open the USB cover,inserting the probe into the USB port of the pulse oximeter,and the red-light of probe will flicker. B. Insert the finger into the probe (the side with finger sign and the nail should be in the same side ).The connected probe could work normally when the luminescent tube in the device emit red light sostenuto.
Figure 3 Fingernails and the luminescent tube should be in the same side. 6.1.3 Pause Alarm a. Alarm includes the alarm of measure data's going beyond the limits(SpO2 and pulse rate value), alarm of low-power, and the alarm of finger out. b. In the measuring interface, if the alarm function is on, during the period of alarming, alarm can be suspended by short pressing menu button,and the screen will appear pause-alarm symbol, but the function will be renewed in about 30 seconds. c.
A Brightness Adjustment In the main menu interface,short press menu button to move the choice bar to the "Brightness" item,then long press menu button to adjust the brightness of screen (4 levels adjustable).
Figure 5 Alarm Setting Menu a The high/low limit of alarm setting In alarm setting menu,short press menu button to move the choice bar to "Dir" item,long press menu button to choose Up or Down.Short press menu button to adjust alarm item:SpO2 high limit (SpO2 ALM HI), SpO2 low limit (SpO2 ALM LO), Pulse rate high limit (PR ALM HI), Pulse rate low limit (PR ALM LO).Long press menu button to change the value.Long press menu button once,and the value raise or descend once.
setting menu as Figure 6. . Figure 6 Record setting Menu a Record segments Display the number of the data segments which have been recorded. b Record setting In the "Record Menu" interface,short press menu button to move the choice bar to the "Record off" item,then long press menu button to begin to record data;here enter the "Record" menu again,in "Record on" menu,long press menu button to stop recording,and the "on" will become "off".
In the main menu interface,short press menu button to move the choice bar to the "System" item,then long press menu button to enter the system setting menu as Figure 7. Figure 7 System Menu a Hard. Ver. The version number of hardware for the device. b Soft. Ver. The version number of software for the device. c Wireless In the "System Menu" interface,short press menu button to move the choice bar to "Wireless off” item,then long press button to turn on the wireless transmission.
transmission.If the user can't set "Wireless" after cutting connecting,please try again after waiting 30 seconds. Recommended adapter: 2.4GHZ adapters which use CSR as main chip. d. Sound Volume In the "System Menu" interface,short press menu button to move the choice bar to "Sound Volume” item,then long press button to change sound volume step by step (3 levels adjustable). e. Device ID The user can set device ID by PC software.Please refer to for details. f.
to "Exit” item, then long press button to exit main Menu and return to the measure interface. H. Clock Setting In the measure interface, Short press power button to enter to the clock interface,and long press button to set time."up" means to adjust time upwards,"down" means to adjust time downwards,and long press button for switching.Short press menu button to change setting item (including: hour, minute, year, month, day, save, Exit, up/down), and long press menu button to set time which has been chosen.
When charging in power-off state, short press power button and the device will display green dynamic state bar.It means that the device is charging.When the state bar is full,the charging is finished. When charging in power-on state,dynamic Power indication symbol displays. It means that the device is charging.When the state bar is full,the charging is finished. If the alarm function is on, the device will provide high-priority alarm signal when the battery is in low power status .
B.The finger should be in a proper position (see the attached illustration as Figure 3 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.
may also be a major factor resulted in serious error of SpO2 measure. D. The SpO2 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.
8 Troubleshooting Trouble Possible Reason Solution The SpO2 and Pulse Rate can not be displayed normally. The finger is not properly positioned. Place the finger properly and try again. The patient’s SpO2 is too low to be detected. Try again; Go to a hospital for a diagnosis if you are sure the device works all right. The finger is not placed inside deep enough. Place the finger properly and try again. The finger is shaking or the patient is moving. Let the patient keep calm.
The device can not be used for full time after charge The battery can not be full charged even after 10 hours charging time. The battery is not full charged. Please recharge the battery The battery is broken Please contact the local service center. The battery is broken Please contact the local service center.
9 Key of symbols Signal Description Warning – See User Manual %SpO2 The pulse oxygen saturation (%) PRbpm Pulse rate (bpm) PI Perfusion Index (%) The battery power is full Low-power Close the alarm sound indication Pause the alarm sound indication Open the alarm sound indication Close the pulse sound indication Open the pulse sound indication Open the Wireless indication 22
Menu button power button IP22 International Protection USB WEEE (2002/96/EC) 23
10 Function specification Information The Pulse Saturation(SpO2) Display Mode Oxygen 2-digit digital OLED display Pulse Rate(PR) 3-digit digital OLED display Perfusion Index (PI) 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% unspecified.
Battery Requirement Voltage 3.7 rechargeable lithium battery × 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. Power Adapter(selected) Output voltage DC 5V Output current 1000mA Wireless Module Transmit frequency 2.
Low voltage alarm 60s 5ms SpO2 alarm 1s 5ms Pulse rate alarm 1s 5ms Probe error alarm 16ms 5ms 26
