User Manual for Handheld Pulse Oximeter 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.
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 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. DO NOT operate in the environment where strong electro-magnetic interference exists, such as radiogram, television, radiophone, etc.
User Manual for Handheld Pulse Oximeter 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..................................................... 3 1.3 Structure ............................................................................... 3 1.4 Features .......................................................................
User Manual for Handheld Pulse Oximeter 1 Overview 1.1 Appearance Alert indicator Display screen Record/Back Menu/Confirm Rotate-lock /Up Power indicator Mute /Right Power/Left Setting/Down Figure 1.
User Manual for Handheld Pulse Oximeter TEMP: Temperature probe connector SpO2: SpO2 probe connector Figure 1.2 Upper-side view DC power input socket 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 5. (Setting/Down): On measuring screen, longtime pressing to enter into setting screen; On menu or sub-menu screen, short time press it to move the cursor downwards or adjust the parameter value. 6. (Menu/Confirm): Short time press it to enter into menu screen, or to confirm the selection. 7. (Record/Back): Short time press it to enter into SpO2 record list screen, or to back to the previous level of menu. 8.
User Manual for Handheld Pulse Oximeter 1.4 Features It is lightweight, small in size and easy to carry Color LCD to display plethysmogram and parameters Measure SpO2, Pulse Rate and Temperature simultaneously PI (Perfusion Index) display is available Up to 500 hours data storage for SpO2 and PR and can be recalled. 16 user IDs for making data and can be added. A built-on holder for convenient standing on desktop and display viewing.
User Manual for Handheld Pulse Oximeter 2 Preparation 2.1 Charger Base Connection Put the device into the charger base properly, and note the polarity markings, as shown in figure 2.1. Oximeter Figure 2.
User Manual for Handheld Pulse Oximeter 2.2 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. 3.
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 recommended that the probe should NOT be applied to the same place for over two hours, change the measurement site periodically and when necessary. When the ambient temperature is over 35℃, please change the measuring site every two hours; when the ambient temperature is over 37℃, please do NOT use the SpO2 sensor, as using in high temperatures can cause burns. Do NOT place the SpO2 probe on a finger with edema or fragile tissue.
User Manual for Handheld Pulse Oximeter ☞ Connector with the label "SpO2" can only be connected with SpO2 probe, and connector with the label "TEMP" can only be connected with the temperature probe. 3.2 Temperature Measurement (optional) The infrared temperature probe is a delicate transducer. To operate please follow these steps and procedures. Failure to accurately operate may cause damage to the probe. The infrared temperature probe is as shown in figure 3.2.
User Manual for Handheld Pulse Oximeter and the temperature unit "℃" is blinking, the user can begin to take the measurement. 3. Insert the tip of the temperature probe into the earhole and press the measuring key to start the measurement. A short beep means the measurement has finished and the result will be displayed on the big display screen on temperature probe and the display screen of the Oximeter.
User Manual for Handheld Pulse Oximeter therefore pressing the power on/off key on the temperature probe will not cause any effect. 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 show the software version, 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 Rotate-lock icon Measurement 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 range Pulse rate mark and unit Pulse symbol HR high/low limit setting range Pulse rate value TEMP value Perfusion index Pulse Plethysmogram Current time Figure 4.
User Manual for Handheld Pulse Oximeter 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 turned on). During measurement, longtime pressing Rotate-lock/Up key " ", then the Rotate-lock icon " " turns to blue " ", it means the auto rotation function is turned on, if you place this oximeter horizontally, then the display shows in horizontal, as shown in figure 4.2B. Figure 4.
User Manual for Handheld Pulse Oximeter blinks. During the measurement, over-limit event or probe off event can activate the alert indication sound. Refer to Section 6.2 for detailed alert indication sound. If the memory is full, the corresponding memory full icon appears on the screen, " full, " " " means temperature memory is " means SpO2 spot-check record memory is full, " means SpO2 continuous record memory is full.
User Manual for Handheld Pulse Oximeter Note: when the device is connecting the neonate SpO2 probe, then the User icon " " turns to grey " upper left corner turns to pink " ", and the patient type on ". Measurement mode: Select the measurement mode, "Spot-check mode" and "Continuous mode" for option. SpO2 record: Recall and review the records stored on the oximeter, two method for option: "Spot-check Record" and "Continuous Record", see Section 4.4 for details. Figure 4.
User Manual for Handheld Pulse Oximeter TEMP Record: Review the temperature record list. Date: Set the time and date, see Section 4.3.6 for details. Setting: Set the system parameter, including lightness, sound volume, display language, power saving mode etc., see Section 4.3.7 for details. Alert: Set the low alert limit for SpO2 and the high/low alert limit for HR, see Section 4.3.8 for details.
User Manual for Handheld Pulse Oximeter 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. Figure 4.
User Manual for Handheld Pulse Oximeter 4.3.3 Measurement Mode On main menu screen, move the cursor on "Measurement Mode" and press Confirm key " ", then the oximeter enters into Measurement Mode Setup screen, as shown in figure 4.6. Figure 4.6 Measurement mode setup screen 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.
User Manual for Handheld Pulse Oximeter On main menu screen, move the cursor on "TEMP Record" and press Confirm key " ", then the oximeter enters into temperature record list screen, as shown in figure 4.8. Figure 4.8 TEMP record list screen 4.3.6 Date On main menu screen, move the cursor on "Date" and press Confirm key " ", then the oximeter enters into date setup screen, as shown in figure 4.9.
User Manual for Handheld Pulse Oximeter Figure 4.9 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 Figure 4.10 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 shown in figure 4.10G. Default setting: Enter into the factory default setting, as shown in figure 4.10H. Version: For viewing version number of the software, as shown in figure 4.10I Demo: Enter into the Demonstration mode, as shown in figure 4.10J. Figure 4.10A Brightness setup Figure 4.10C Figure 4.10E Language setup Wireless setup Figure 4.10B Figure 4.10D Volume setup Auto Power OFF setup Figure 4.
User Manual for Handheld Pulse Oximeter Figure 4.10G TEMP unit setup Figure 4.10H Default setting Figure 4.10I Version info. Figure 4.
User Manual for Handheld Pulse Oximeter 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 for adult is 50bpm and 60bpm for pediatric. Note: When the SpO2 reading is lower than or equal to the preset alert setting or the PR reading is higher than or equal to the preset high limit or the PR reading is lower than or equal to the preset low limit, then the over-limit alert event will be activated, that's, the alert sound "bibibibi..." occurs, and the corresponding reading(s) blinks.
User Manual for Handheld Pulse Oximeter Figure 4.
User Manual for Handheld Pulse Oximeter Figure 4.12 Help information---TEMP measurement 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.
User Manual for Handheld Pulse Oximeter Figure 4.13 SpO2 record SpO2 record includes Spot-check Record and Continuous Record, Spot-check Record list shows the recording time, SpO2 value and pulse rate value, as shown in figure 4.14. The corresponding User and User ID for the selected record Figure 4.14 Spot-check Record list If Continuos Record is selected, then the screen shows the Continuos Record list, as shown in figure 4.
User Manual for Handheld Pulse Oximeter key( " / ") to select one record you need to review. Select one record you need to review, and press Confirm key " ", then the screen shows the corresponding User, User ID, and trend graph, as shown in figure 4.16. 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 Continuos 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 Mute/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, PR and TEMP 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 5 Technical Specifications A. Display Panel: 3.5 inch color TFT LCD; B. Power Supply: Internal power supply: 2000mAh lithium battery AC power adapter: 5VDC/1A, Working current: ≤ 180mA Input power for AC power adapter: <15VA The typical continuous operation time of the battery: 18 hours (when screen display is automatically off and bluetooth function is disabled). The typical service life of the battery: 5 years. C.
User Manual for Handheld Pulse Oximeter The SpO2 value update time is less than 30 seconds. The pulse rate value update time is less than 10 seconds. F. Perfusion Index Display Range: 0.2%~20% G. Temperature Measurement Measuring range: 32.0℃~43.0℃ Measuring accuracy: ±0.2℃ for temperature range from 35.0℃ to 42.0℃, and ±0.3℃ for the rest. Response time: ≤5s H.
User Manual for Handheld Pulse Oximeter Degree of protection against harmful ingress of liquids: The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid. Mode of operation: Continuous operation. Electro-Magnetic Compatibility: Group I, Class B 6 Over-limit Indication 6.1 Limit settings SpO2 low limit setting range: 50% ~ 99%.
User Manual for Handheld Pulse Oximeter 7 Packing List 1. An Oximeter 2. A SpO2 probe 3. User Manual 4. A oximeter rubber cover 5. A charging base 6. A temperature probe (optional) 7. Charging cable (optional) 8. A USB data cable (optional) Notes: 1. The accessories are subject to change. See the package in your hand for detailed items and quantity. 2. All the parts of the device should NOT be replaced at will.
User Manual for Handheld Pulse Oximeter 8 Repair and Maintenance 8.1 Maintenance The expected service life(not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance; If the battery is damaged, please contact your local sales representative or the manufacture. Please store the device carefully to avoid being damaged by pets, pests or children.
User Manual for Handheld Pulse Oximeter 9 Troubleshooting Trouble Possible Reason 1. The finger is not Unstable placed far enough SpO2 and inside. Pulse Rate 2. The finger is display shaking or the patient is moving. Unable to 1. Temperature probe measure is not connected Temperature properly Device will not switch on No Display No Signal 1. The batteries are drained or almost drained. 2. The batteries are not inserted properly. 3. The device is malfunctioning. 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. 4.
User Manual for Handheld Pulse Oximeter b) Exposure to excessive illumination, such as surgical lamps, 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 proxim
User Manual for Handheld Pulse Oximeter Appendix I Key of Symbols Symbol Description %SpO2 The oxygen saturation PI% Perfusion Index bpm Pulse rate (Unit: beats per minute) Pulse bar graph Low battery voltage Symbols Battery is full on the Speaker mute icon screen Speaker volume icon SpO2 spot-check record memory full SpO2 continuous record memory full Temperature memory full Wireless transmission icon / (Pediatric/Adult) Patient type 40
User Manual for Handheld Pulse Oximeter Symbol Description SpO2 TEMP SpO2 probe connector Temperature probe connector Power/Left Key Mode/Right Key Rotate-lock/Up Key Symbols on the panels Setting/Down Key Menu/Confirm key or Record/Back key SN CE mark Serial number 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 41
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 Clinical application of pulse oximeters: SpO2 is an important physiological parameter to reflect the respiration and ventilation function, so SpO2 monitoring used in clinical becomes more popularly, such as monitoring the patient with serious respiratory disease, the patient under anesthesia during operation, premature and neonate.
User Manual for Handheld Pulse Oximeter hyperkinesias or body temperature decreasing 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 44
User Manual for Handheld Pulse Oximeter III EMC The equipment meets the requirements of IEC 60601-1-2:2014. Table 1 Guidance and manufacturer’s declaration-electromagnetic emission The Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Oximeter should assure that it is used in such an environment.
User Manual for Handheld Pulse Oximeter Table 2 Guidance and manufacturer’s declaration-electromagnetic emission The Oximeter is intended for use in the electromagnetic environment specified below. the customer or the user of the Oximeter should assure that it is used in such an environment. Electromagnetic IEC60601 test Complianc Immunity test environment level e level -guidance ±6 kV contact ±8kV air Floors should be wood, concrete or ceramic tile.
User Manual for Handheld Pulse Oximeter <5% UT (>95% dip in UT) for 0.5 cycle Voltage dips, <40% UT short (60% dip in UT) for interruptions and 5 cycles voltage variations <70% UT on power supply (30% dip in UT) for input lines 25 cycles IEC61000-4-11 <5% UT (>95% dip in UT) for 5 s Power frequency( 50Hz/60Hz) magnetic field IEC61000-4-8 3A/m N/A 3A/m N/A Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
User Manual for Handheld Pulse Oximeter Immunity test Conducted RF IEC61000-4-6 IEC60601 test level Compliance Electromagnetic level environment -guidance 3 Vrms 150 kHz to 80 MHz N/A 3 V/m 80 MHz to 2.5 GHz 3 V/m Radiated RF IEC61000-4-3 48 Portable and mobile RF communications equipment should be used no closer to any part of The Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
User Manual for Handheld Pulse Oximeter determined by an electromagnetic site survey ,a should be less than the compliance level in each frequency range .b Interference may occur in the vicinity of equipment marked with the following symbol. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
User Manual for Handheld Pulse Oximeter a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered.
User Manual for Handheld Pulse Oximeter 1 N/A 1.2 2.3 10 N/A 3.8 7.3 100 N/A 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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.
User Manual for Handheld Pulse Oximeter This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
User Manual for Handheld Pulse Oximeter Quality Inspection Certificate 53
