Handheld Pulse Oximeter User Manual
Instructions to User Dear Customer, Thank you for purchasing this quality product. Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. We reserve the right to revise and amend it at any time without prior notice. Version of the Manual: 1.
User Manual for Handheld Pulse Oximeter Instructions for Safe Operation Check the device to make sure that there is no visible damage that may affect user’s safety and measurement performance. It is recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device. Necessary service must be performed only by qualified technicians. Users are not permitted to service this device.
User Manual for Handheld Pulse Oximeter Biocompatibility tests have been performed on all the applied parts, some exceptional allergic patients may still have anaphylaxis. Do not apply to those who have anaphylaxis. For the individual patients, there should be a more prudent inspecting in the placing process. The sensor can not be placed on the edema and tender tissue. The local law should be followed when disposing of the expired device or its accessories.
User Manual for Handheld Pulse Oximeter ☞ The intended use of this device is not for therapy purpose. ☞ The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid. So that means the equipment is protected against solid foreign objects of 12.5mm and greater, and protected against vertically falling water drops when enclosure tilted up to 15°. ☞ Please pay attention to the effects of lint, dust, light (including sunlight), etc.
User Manual for Handheld Pulse Oximeter Table of Contents 1 Overview....................................................................................... 1 1.1 Appearance............................................................................1 1.2 Product Name and Model..................................................... 4 1.3 Structure................................................................................ 4 1.4 Features.......................................................................
User Manual for Handheld Pulse Oximeter I Key of Symbols.........................................................................43 II Common Knowledge...............................................................45 Quality Inspection Certificate.......................................................
User Manual for Handheld Pulse Oximeter 1 Overview 1.1 Appearance Alert indicator Display screen Menu/Confirm Record/Back Auto-rotate /Up Power indicator Right/Sound Power/Left Setting/Down Figure 1.
User Manual for Handheld Pulse Oximeter SpO2: SpO2 probe connector Figure 1.2 Upper-side view USB connector DC power input contact shoes with polarity indication Figure 1.3 Bottom side view 1. Display screen: Display measurement result, trends and menus. 2. (Power/Left): Power on/off the device by longtime pressing; On menu or sub-menu screen, short time press it to move the cursor left or adjust the parameter values. 3.
User Manual for Handheld Pulse Oximeter adjust the parameter values. 4. (Auto-rotate/Up): On measuring screen, longtime pressing to enable or disable the automatic screen orientation (on horizontal or vertical direction); On menu or sub-menu screen, short time press it to move the cursor upwards or adjust the parameter value. 5.
User Manual for Handheld Pulse Oximeter 1.2 Product Name and Model Name: Handheld Pulse Oximeter Model: SP-20 1.3 Structure It consists of the main unit and SpO2 probe. 1.
User Manual for Handheld Pulse Oximeter 1.5 Intended Use This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate and functional oxygen saturation (SpO2) . It is applicable for detecting SpO2, for sports or aviation use only. The data and results provided by this device should not used to diagnose or treat any medical condition. 1.
User Manual for Handheld Pulse Oximeter 2 Power Supply 1. Internal power supply with built-in battery: Built-in battery specification: 2000mAh lithium battery. 2. External power from the AC power adapter: Use the AC power adapter provided by the manufacturer. Make sure the mains power supply is 100-240VAC with 50/60Hz. Note: it’s recommended to use the AC power adapter provided by the manufacturer. 3. The Base: Input: Micro USB connector, 5VDC/1A Micro USB connector Output: Contact pins.
User Manual for Handheld Pulse Oximeter 1) When the oximeter is held by the base, you can connect one end of the USB cable to the USB connector on the back of the base marked with “DC 5V/1A”, and the other end to the USB power source with output capacity of 5V DC/1A; 2) If the oximeter is not held by the base, then you can just connect one end of the USB cable to the USB connector on the device marked with " ", and the other end to the USB power source with output capacity of 5V DC/1A.
User Manual for Handheld Pulse Oximeter Oximeter Insert the oximeter into the base by this direction Base Figure 2.
User Manual for Handheld Pulse Oximeter 3 Make Measurement 3.1 SpO2 Measurement Operation procedures: 1. Connect the SpO2 probe to the connector on the upper-side of the device marked with "SpO2". (Note: When disconnecting the connector, be sure to hold the head of the connector firmly and pull). 2. The red blinking light inside the clip of the SpO2 probe indicates a successful connection. 3.
User Manual for Handheld Pulse Oximeter Safety instructions for SpO2 measurement Long term use of the SpO2 probe on the same place may result in discomfort or pain, especially for those with microcirculatory problems. It is recommended that the probe should NOT be applied to the same place for over two hours, change the measurement site periodically and when necessary.
User Manual for Handheld Pulse Oximeter fingernail. The fingernail should be of normal length. The SpO2 sensor cannot be immersed into water, liquid or cleanser. The SpO2 sensor can be repeatedly used. Please clean and disinfect before reuse. ☞ Connector with the label "SpO2" can only be connected with SpO2 probe.
User Manual for Handheld Pulse Oximeter 4 Operation 4.1 Power on/off the Oximeter Long pressing" " Power/Left key for 1~2 seconds, then the oximeter will be powered on. The oximeter will do self-test and then the software version and warning message "Professional attendance is required for continuous monitoring!" will be shown on the screen, as shown in figure 4.1 (refer to your oximeter for actual version). Figure 4.1 4.
User Manual for Handheld Pulse Oximeter Wireless icon Auto-rotate icon Recording mode Auto power off disable icon User ID Sound indicator Patient type Battery indicator SpO2 mark SpO2 value Pulse Strength bar-graph SpO2 high/low limit setting value Pulse rate mark and unit Pulse symbol HR high/low limit setting value Pulse Rate value Perfusion index Plethysmogram Current time Description: Figure 4.
User Manual for Handheld Pulse Oximeter blinking on the screen, and "bibibi..." alert sound appears simultaneously. Alert sound is sustaining for about 3 minutes, and if there is no any key operation in this period, then the device will power off automatically (if the auto power off function is enabled).
User Manual for Handheld Pulse Oximeter pressing " " key. Longtime pressing " " key again can disable the global sound, that’s to say, the speaker is turned off at all, therefore, no pulse beep sound, no audible alert and no key click sound. If the global sound is enabled by longtime pressing " " key, then during the measurement, over-limit alert event or probe off event can activate the audible alert. Refer to Section 6.2 for detailed alert indication sound.
User Manual for Handheld Pulse Oximeter Figure 4.3 Main menu There are 9 functional icons in main menu screen, press Up/Down/Left/Right key can move the cursor to make selection and press " " Menu/Confirm key again to confirm the selection. User ID: Add new or edit the current User ID. User: Select patient type, "Adult" and "Neonate" for option.
User Manual for Handheld Pulse Oximeter upper left corner turns to pink " ". Recording mode: Select the data recording "Spot-check Record" and "Trend Record" for option. mode, SpO2 record: Recall and review the records stored on the oximeter, two types of record for option: "Spot-check Record" and "Trend Record", see Section 4.4 for details. Date: Set the time and date, see Section 4.3.6 for details.
User Manual for Handheld Pulse Oximeter Figure 4.4A User ID setup screen Move the cursor on "Edit" and press Confirm key " ", when the cursor turns to blue, then the user can edit the User ID, and move the cursor on "OK" to confirm the edit, the edit screen is as shown in figure 4.4B. Figure 4.4B User ID edit screen 4.3.2 User On main menu screen, move the cursor on "User" and press Confirm key " ", then the oximeter enters into Patient type Setup screen, as shown in figure 4.5.
User Manual for Handheld Pulse Oximeter Figure 4.5 Patient type setup screen 4.3.3 Recording Mode On main menu screen, move the cursor on "Recording Mode" and press Confirm key " ", then the oximeter enters into Recording Mode Setup screen, as shown in figure 4.6. Figure 4.
User Manual for Handheld Pulse Oximeter should exceed 30 seconds, or no one record will be recorded in Trend data record list. 4.3.4 SpO2 Record On main menu screen, move the cursor on "SpO2 Record" and press Confirm key " ", then the oximeter enters into SpO2 record review method selecting screen, as shown in figure 4.7. Figure 4.7 SpO2 record review method selecting screen Refer to Section 4.4 for details. 4.3.
User Manual for Handheld Pulse Oximeter Figure 4.8 Date setup screen Date setting procedure: 1) Move the cursor stays on the Year of the date, press Confirm key " " to active Year option, the cursor flashes on the Year of the date; 2) Press Up/Down key to adjust Year; 3) Press " " (Confirm) key to confirm and exit from date setting; 4) The procedures of adjusting Month, Day, Hour, Minute and Second value are the same with Year adjustment.
User Manual for Handheld Pulse Oximeter setting screen, as shown in figure 4.10. Figure 4.9 System setting screen Description: Brightness: To set the brightness of backlight, 6 levels for optional, the factory default is level 3, as shown in figure 4.10A. Volume: To set the sound volume (including alert sound, pulse beep sound and key click sound), 6 levels sound volume for optional, the factory default is level 3, as shown in figure 4.10B.
User Manual for Handheld Pulse Oximeter default is "English", as shown in figure 4.10D. Auto power off: To turn on/off the Auto Power Off mode, the factory default is "On", as shown in figure 4.10E. Wireless: To turn on/off the wireless connection function, the factory default is "On", as shown in figure 4.10F. Power saving mode: To turn on/off the Power Saving mode, the factory default is "On", as shown in figure 4.10G.
User Manual for Handheld Pulse Oximeter Figure 4.10E Auto Power OFF setup Figure 4.10G Figure 4.10H Figure 4.10F Wireless setup Power Saving setup Version info Figure 4.
User Manual for Handheld Pulse Oximeter Figure 4.10J Demo mode Notes: When the Auto Power Off is set to "On" option, if there is no key operation for 3 minutes, then the oximeter will power off automatically. When the Power Saving Mode is set to "On" option, during the measurement, if there is no key operation for 1 minute, the screen display will be dim for power saving. The display brightness will resume to normal condition by pressing any key. 4.3.
User Manual for Handheld Pulse Oximeter Figure 4.11 Alerts setting screen SpO2 Lo-Limit: SpO2 low limit setting; range: 50%~99%, the step is 1%. The factory default value for adult is 90% and 95% for Neonate. PR Hi-Limit: High limit setting of pulse rate; range: 100~240bpm. From 100 to 150, the step is 1bpm, and from 150 to 240, the step is 5bpm. The factory default value for adult is 120bpm and 160bpm for neonate. PR Lo-Limit: Low limit setting of pulse rate; range: 30~99bpm, and the step is 1bpm.
User Manual for Handheld Pulse Oximeter 4.3.9 Help On main menu screen, move the cursor on "Help" and press Confirm key " ", then the oximeter help information screen, which shows SpO2 tips, as shown in figure 4.12. Figure 4.
User Manual for Handheld Pulse Oximeter 4.4 Record 4.4.1 Data Recall On main default screen, short time press Record/Back key " " to enter into data recall screen, as shown in figure 4.13. Figure 4.13 SpO2 record SpO2 records include two types, Spot-check and Trend Record, Spot-check Record is a list showing the recording time, SpO2 value and pulse rate value for each spot-checking event, as shown in figure 4.14.
User Manual for Handheld Pulse Oximeter The corresponding User and User ID for the selected record Figure 4.14 Spot-check Record list If Trend Record is selected, then the screen shows a list of trend data record, and each record corresponds to a period of recording at a fixed time interval (1 second), as shown in figure 4.15, press Up/Down key ( " / ") to select one record you need to review.
User Manual for Handheld Pulse Oximeter The corresponding User and User ID for the selected record Figure 4.
User Manual for Handheld Pulse Oximeter The corresponding User and User ID for the selected record Recording time SpO2 trend graph PR trend graph Figure 4.16 Trend record---Trend graph 4.4.2 Data Deletion On the record list screen shown in figure 4.14 or 4.15, move the cursor on the record you want to delete, and longtime pressing Sound/Right key(" "), then an message “Are you sure to delete all?” prompts on the screen, as shown in figure 4.16.
User Manual for Handheld Pulse Oximeter Figure 4.16 Delete records At this time, short time press Menu/Confirm (" ") key to confirm and delete the records. Or short time press Record/Back (" ") key to return to record list screen. 4.4.3 Data Upload If you want to upload the stored data (SpO2 and PR values) to the computer, then Make sure the provided USB data cable is well connected between the device and PC before uploading data, as shown in figure 4.17.
User Manual for Handheld Pulse Oximeter scan the SP-20 Oximeter. b. The host will pair with the SP-20 Oximeter at a moment. c. After connecting, the host can display and manage the measurement data of SP-20 by wireless. The pairing and transmitting distance of wireless function is 8 meters in the normal. If the host can’t pair with the SP-20, you will try to narrow the distance between the host and SP-20.
User Manual for Handheld Pulse Oximeter Display range: 0~100% Measuring accuracy: ARMS value (defined in ISO 80601-2-61) is not greater than 2% for SpO2 range from 70% to 100%. SpO2 low alert limit setting range: 50%~99% The device is calibrated to display functional oxygen saturation. The functional tester cannot be used to assess the accuracy of the SpO2 probe or the device. D. Pulse Rate Measurement Display and measuring range: 30bpm~250bpm Accuracy: ±2bpm or ±2% (whichever is greater) E.
User Manual for Handheld Pulse Oximeter Frequency band: 2.4GHz Working profile: BLE V4.0 J. Dimensions: 158 mm (L) × 73 mm (W) × 25 mm (H) Net Weight: about 230g (including battery) K. Classification Type of protection against electric shock: Internally powered equipment and Class II. Degree of protection: Type BF applied parts. Degree of protection against harmful ingress of liquids: The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid.
User Manual for Handheld Pulse Oximeter there is no need for user to calibrate again. 6 Over-limit Indication 6.1 Limit settings SpO2 low limit setting range: 50% ~ 99%. Pulse Rate limits setting range: High: 100bpm--240bpm Low: 30bpm--99bpm During the measurement, if the measured value exceeds the preset value, the alert beeping sound will be activated, the value that is over-limit will blink at the same time. 6.
User Manual for Handheld Pulse Oximeter pressing “ ” key cam disable the global sound, and the sound icon becomes “ ”. Longtime pressing “ ” key again can enable the global sound. Note: “ ” means the speaker volume is set as 1 or 2 grid(s); “ ” means the speaker volume is set as 3 or 4 grids; “ ” means the speaker volume is set as 5 or 6 grids. During the measurement, if the probe is off or disconnected, the message "Check Probe" shows and keeps blinking on the display screen.
User Manual for Handheld Pulse Oximeter necessary, please use the components provided by the manufacture or those that are of the same model and standards as the accessories along with the device which are provided by the same factory. Otherwise, negative effects concerning safety and biocompatibility etc. may be caused. 3. This device can only connect with the manufacture nominated device. 8 Repair and Maintenance 8.1 Maintenance The expected service life(not a warranty) of this device is 5 years.
User Manual for Handheld Pulse Oximeter 8.2 Cleaning and Disinfecting Instruction Surface-clean sensor with a soft cloth by wetting with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a 1:10 bleach solution. Then surface-clean by a dampened cloth and let it air dry or wipe it with a cloth. Please clean and disinfect the device after using to avoid cross infection. High-pressure disinfection cannot be used on the device. Do not immerse the device in liquid.
User Manual for Handheld Pulse Oximeter 9 Troubleshooting Trouble Unstable SpO2 and Pulse Rate display Device will not switch on No Display No Signal Possible Reason 1. The finger is not placed far enough inside. 2. The finger is shaking or the patient is moving. 1. The batteries are drained or almost drained. 2. The device is malfunctioning. 1. The device will power off automatically when there is no signal and no operation for 1 minute. 2. The battery voltage is low. 1.
User Manual for Handheld Pulse Oximeter 10 Frequently Asked Questions 1. Q: What's SpO2? A: SpO2 means the saturation percentage of oxygen in the blood. 2. Q: What's the normal range of SpO2 value for healthy people? A: The normal range varies by individual, but usually over 95%, otherwise, please consult your physician. 3. Q: What's the normal range of PR value for healthy people? A: Usually, the normal range is 60bpm~100bpm. 5.
User Manual for Handheld Pulse Oximeter bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight; c) Vascular dyes or external used color-up product such as nail enamel or color skin care; d) Excessive patient movement; e) Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line; f) Exposure to the chamber with High pressure oxygen; g) There is an arterial occlusion proximal to the sensor; h) Blood vessel contraction caused by periphe
User Manual for Handheld Pulse Oximeter Appendix I Key of Symbols Symbol Description %SpO2 PI% The oxygen saturation Perfusion Index Pulse rate (Unit: beats per minute) bpm Pulse bar graph Low battery voltage Symbols on the Battery is full screen Alert reset icon Speaker mute icon / / Speaker volume icon SpO2 spot-check record memory full SpO2 trend record memory full Wireless transmission icon / (Neonate/Adult) Patient type 43
User Manual for Handheld Pulse Oximeter Description Symbol SpO2 SpO2 probe connector Power/Left Key Right/ Sound Key Auto-rotate/Up Key Setting/Down Key Symbols on the panels Menu/Confirm key or Record/Back key SN Serial number CE mark Authorized representative in the European Community Date of manufacture Manufacturer (including address) With Type BF applied part See User Manual Disposal of this device according to WEEE regulations No alarm Do not litter at will 44
User Manual for Handheld Pulse Oximeter II Common Knowledge 1 Meaning of SpO2 SpO2 is the saturation percentage of oxygen in the blood, so called O2 concentration in the blood; it is defined by the percentage of oxyhemoglobin (HbO2) in the total hemoglobin of the arterial blood.
User Manual for Handheld Pulse Oximeter dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin. 3 Normal SpO2 Range and Default Low Limit In campagna area, healthy people’s SpO2 value is greater than 94%, so the values below 94% are determined as hypoxia. SpO2<90% is considered as the default threshold for determining anoxia by most researchers, so SpO2 low limit of the oximeter is set as 90% generally.
User Manual for Handheld Pulse Oximeter 5 Factors causing low SpO2 value (pathology reason) Hypoxemia disease, functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 47
User Manual for Handheld Pulse Oximeter Quality Inspection Certificate 48