Creative Industry SP-20 Handheld Pulse Oximeter User Manual

Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter

User manual

User Manual for Handheld Pulse Oximeter I 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: Ver 1.0 Issued Date: December 20th, 2016 All rights reserved. Notes:  The contents contained in this manual are subject to change without prior notice.  Information furnished by Creative is believed to be accurate and reliable. However, no responsibility is assumed by Creative for its use, or any infringements of patents or other rights of third parties that may result from its use. 3502-2290079
User Manual for Handheld Pulse Oximeter II 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.  The oximeter must not be used with the devices and accessories not specified in User Manual. Cautions  Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents.  DO NOT use the oximeter while the Patient is under MRI or CT scanning. This device is NOT MRI Compatible. Warnings  Discomfort or pain may occur if using the sensor of this device continuously on the same location for a long time, especially for the patients with poor microcirculation. It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours or less if any abnormal condition is found. Frequently check and re-position the Oximeter sensor.  Misapplication of a SpO2 probe with excessive pressure for prolonged periods can induce pressure injury.  Place the SpO2 probe on the finger tightly will cause venous pulse and effect blood circulation, and lead to interstitial edema, hypoxia and inaccurate measurement.  Biocompatibility tests have been performed on all the applied parts, some exceptional allergic patients may still
User Manual for Handheld Pulse Oximeter III 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.  Please pay attention to the SpO2 probe cable while using to avoid strangulating patient. Attentions  Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.  If the Oximeter gets wet, please stop operating it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for the Oximeter to reach ambient temperature.  DO NOT operate the button on the front panel with sharp materials or sharp point.  DO NOT use high temperature or high pressure steam disinfection on the oximeter and probes. Refer to related chapter for instructions regarding cleaning and disinfection.  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
User Manual for Handheld Pulse Oximeter IV 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. Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards: IEC 60601-1:2005+A1: 2012, IEC60601-1-2:2014, IEC60601-1-11:2010, ISO 80601-2-61:2011 and follows the provisions of the council directive MDD93/42/EEC. Caution: U.S. federal law restricts this device to sale or use by or on the order of a physician.
User Manual for Handheld Pulse Oximeter V Table of Contents 1 Overview ..................................................................................... 1 1.1 Appearance .......................................................................... 1 1.2 Product Name and Model ..................................................... 3 1.3 Structure ............................................................................... 3 1.4 Features ................................................................................ 4 1.5 Intended Use ........................................................................ 4 1.6 Working Environment .......................................................... 4 2 Preparation ................................................................................ 5 2.1 Charger Base Connection ..................................................... 5 2.2 Power Supply ....................................................................... 5 3 Make Measurement ................................................................... 7 3.1 SpO2 Measurement ............................................................... 7 3.2 Temperature Measurement (optional) .................................. 9 4 Operation .................................................................................. 11 4.1 Power on/off the Oximeter ................................................. 11 4.2 Default Display Screen ...................................................... 11 4.3 Menu .................................................................................. 14 4.4 Record ................................................................................ 27 5 Technical Specifications .......................................................... 32 6 Over-limit Indication ............................................................. 34 6.1 Limit settings ..................................................................... 34 6.2 Over-limit indication sound mute setting ........................... 34 7 Packing List .............................................................................. 35 8 Repair and Maintenance ......................................................... 36 8.1 Maintenance ....................................................................... 36 8.2 Cleaning and Disinfecting Instruction ................................ 36 9 Troubleshooting ....................................................................... 37 Appendix ..................................................................................... 38 Quality Inspection Certificate .................................................... 53
User Manual for Handheld Pulse Oximeter 1 1 Overview 1.1 Appearance Power/Left Mute /Right Display screen Figure 1.1 Front View Rotate-lock /Up Setting/Down Alert indicator Menu/Confirm Record/Back Power indicator
User Manual for Handheld Pulse Oximeter 2 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. (Mute/Right): On data recall screen, longtime press this key, then the delete dialog pops up; On measuring screen, short time press it to resume or mute the alert sound. On non-alert status, short time press it to turn on/off beep sound. On menu or sub-menu screen, short time press it to move the cursor right or adjust the parameter values. Note: when the device alert indication is on, short time pressing will mute the alert sound, the mute state will persist for about 90s. After this mute period (90s), then the alert sound will resume. 4. (Rotate-lock/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. Figure 1.2 Upper-side view Figure 1.3 Bottom side view SpO2: SpO2 probe connector TEMP: Temperature probe connector DC power input socket
User Manual for Handheld Pulse Oximeter 3 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. (Alert indicator): If the probe is not well placed or disconnected, or the measured value exceeds the preset alert limit value, then the alert indicator will keep orange flashing. 9. (Power saving mode indicator): If the device is set as power saving mode, then the indicator keeps on. And on measuring screen, the indicator flashes with the pulse beep. 10. Icon: "SpO2"( ): SpO2 Probe Connector. 11. Icon: "TEMP"( ): Temperature Probe Connector. 12. (DC power input): used for connecting external DC power input for charging the built-in rechargeable battery. 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. (Note: with optional temperature probe, this Oximeter can make temperature measurement.)
User Manual for Handheld Pulse Oximeter 4 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.  Real-time battery status display and low battery voltage indication.  Auto power off is available  Audible and visual alert function is available  Data uploading to PC for management (Optional)  Power saving mode is available 1.5 Intended Use This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is applicable for detecting SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. 1.6 Working Environment Operating temperature: 5~40℃ Operating humidity: 15%~93% (non-condensing) Atmospheric pressure: 70kPa~106kPa
User Manual for Handheld Pulse Oximeter 5 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. Figure 2.1 Charger base connection充电底座连接 Oximeter Charger base
User Manual for Handheld Pulse Oximeter 6 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. External power supply from the USB cable: Use the USB cable with micro-USB connector, connect one end of the USB cable to the connector on the device marked with " " or to the USB connector on the charger base marked with " ", and the other end to the USB power source with output capacity of 5V DC/1A. Note: When using the supplied charger base for power supply, please do not tilt the charger base backwards too much, or the USB cable and the connector may be damaged.
User Manual for Handheld Pulse Oximeter 7 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. Insert one finger (index finger is preferred, the nail should be not too long) into the clip of the probe according to the finger mark,as shown in figure 3.1. 4. The device will begin to take the measurement, and the measured result will be displayed on the screen, as shown in figure 4.2. Figure 3.1 demonstration for SpO2 probe Safety instructions for SpO2 measurement  Continuous use of the SpO2 probe may result in discomfort or pain, especially for those with microcirculatory problems. It is
User Manual for Handheld Pulse Oximeter 8 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.  Do NOT put the SpO2 probe and pressure cuff on the same limb, otherwise the blood pressure measurement may affect the SpO2 measurement.  The device is calibrated to display functional oxygen saturation.  Do NOT allow the sensor cable to twist or bend.  Check the SpO2 sensor and cable before use. Do NOT use a damaged SpO2 sensor.  When the temperature of the SpO2 sensor is abnormal, do not use it further.  Remove nail polish or other cosmetic products from the 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.
User Manual for Handheld Pulse Oximeter 9 ☞ 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. Please place the infrared temperature probe in a stable ambient temperature for 30 minutes before taking a measurement. Operation procedure: 1. Connect the infrared temperature probe to the connector on the upper side of device marked with "TEMP". 2. When the screen shows as the big display screen in figure 3.2 Small screen Measuring tip of temperature probe Measuring key Figure 3.2 the infrared temperature probe Power on/off key Temperature Probe Cover Battery cover Big display screen
User Manual for Handheld Pulse Oximeter 10 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. Note:  If the temperature probe detects a hardware failure, the display screen on the infrared temperature probe will show "Err" and will not enter into measurement mode.  The infrared temperature probe will switch to standby state automatically if there is no operation for 1 minute. If a further measurement is needed, press the measuring key and repeat step 2 and step 3.  Normal body temperature varies depending on the position/area the measurement is taken from. The following table shows the varying temperature ranges of the different body positions. Temperature varying range at different body positions: Arm 34.7 ~ 37.3 ℃ Oral 35.5 ~ 37.5 ℃ Rectal 36.6 ~ 38.0 ℃ Ear 35.8 ~ 38.0 ℃ Safety Instruction for Temperature Measurement  Do NOT take a measurement when the patient is moving.  Patients with tympanitis or otitis problems should NOT use this device.  When the infrared temperature probe is connected to the device, the probe will consequently be at power-on status,
User Manual for Handheld Pulse Oximeter 11 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 4.2 Default Display Screen Press “ ”power key for 2 seconds to start up the Oximeter, then the screen will display the default screen, as shown in Figure 4.2.
User Manual for Handheld Pulse Oximeter 12 Description:  During measurement, if the finger is not inserted properly, or the probe is not connected or the probe is off from the finger, then "Check Probe" message prompts on the screen, and "bibibi..." alert sound appears simultaneously. Alert sound is SpO2 mark SpO2 value Pulse Plethysmogram Current time SpO2 high/low limit setting range Patient type Sound indicator Battery indicator Pulse rate mark and unit Pulse Strength bar-graph Pulse symbol Pulse rate value Figure 4.2A Default Display Screen---in vertical HR high/low limit setting range User ID Measurement mode Auto power off disable icon Wireless icon Rotate-lock icon TEMP value Perfusion index
User Manual for Handheld Pulse Oximeter 13 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.  Sound indicator " " means the device is on mute status, the user can turn on the indication sound by short pressing " " key. Short time press " " key can turn off (or resume) the device sound (including pulse beep sound, audible alert and key click), while the pulse symbol " " still Figure 4.2B Default Display Screen---in horizontal
User Manual for Handheld Pulse Oximeter 14 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, " " means temperature memory is full, " " means SpO2 spot-check record memory is full, " " means SpO2 continuous record memory is full. No display of the icon means the current corresponding storing space is not full. If the memory is full, the data storing will continue in such way the new record will overwrite the oldest record, so that it's recommended to upload the stored data into the computer in time. 4.3 Menu On the default measuring screen, short time press " " Menu/Confirm key for entering into main menu screen (as shown in Figure 4.3). 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 "Pediatric" for option.
User Manual for Handheld Pulse Oximeter 15 Note: when the device is connecting the neonate SpO2 probe, then the User icon " " turns to grey " ", and the patient type on upper left corner turns to pink " ".  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 4.3 Main menu
User Manual for Handheld Pulse Oximeter 16  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.  Help: To view the tips information of SpO2 measurement and temperature measurement, see Section 4.3.9 for details. 4.3.1 User ID On main menu screen, move the cursor on "User ID" and press Confirm key " ", then the oximeter enters into User ID Setup screen, as shown in figure 4.4. Figure 4.4A User ID setup screen
User Manual for Handheld Pulse Oximeter 17 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 4.5 Patient type setup screen
User Manual for Handheld Pulse Oximeter 18 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 4.7 SpO2 record review method selecting screen Refer to Section 4.3 for details. 4.3.5 TEMP Record
User Manual for Handheld Pulse Oximeter 19 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 20 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. Date Format: DD-YY-MM; Time Format: HH:MM:SS Note: The setting operations of other parameters (such as User ID, User, Auto Power Off, Power Saving etc.) are the same with date setting. 4.3.7 Setting On main menu screen, move the cursor on "Setting" and press Confirm key " ", then the oximeter enters into system setting screen, as shown in figure 4.10.
User Manual for Handheld Pulse Oximeter 21 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.  Language: This oximeter provides the display with two languages: English and Simplified Chinese, the factory default is "English", as shown in figure 4.10C.  Auto power off: To turn on/off the Auto Power Off mode, the factory default is "On", as shown in figure 4.10D.  Wireless: To turn on/off the wireless connection function, the factory default is "On", as shown in figure 4.10E.  Power saving mode: To turn on/off the Power Saving mode, the factory default is "On", as shown in figure 4.10F  TEMP unit: To set the temperature unit, "℃(Celsius)" and "℉(Fahrenheit)" for option, the factory default is "℉", as
User Manual for Handheld Pulse Oximeter 22 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 4.10B Volume setup Figure 4.10C Language setup Figure 4.10D Auto Power OFF setup Figure 4.10E Wireless setup Figure 4.10F Power Saving setup
User Manual for Handheld Pulse Oximeter 23 Notes：  When the Auto Power Off is set to "On" option, if there is no Figure 4.10G TEMP unit setup Figure 4.10I Version info. Figure 4.10H Default setting Figure 4.10J Demo mode
User Manual for Handheld Pulse Oximeter 24 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. 4.3.8 Alert On main menu screen, move the cursor on "Alert" and press Confirm key " ", then the oximeter enters into alert setting screen, as shown in figure 4.11. Figure 4.11 Alert 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 pediatric.  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 pediatric.  PR Lo-Limit: Low limit setting of pulse rate; range: 30~99bpm, and the step is 1bpm. The factory default value
User Manual for Handheld Pulse Oximeter 25 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. When measured on pediatric, if the SpO2 reading is lower than or equal to the preset alert setting for 10 seconds, then the alert sound and blinking display will be activated. 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 and temperature measurement tips, as shown in figure 4.12.
User Manual for Handheld Pulse Oximeter 26 Figure 4.12 Help information---SpO2 measurement
User Manual for Handheld Pulse Oximeter 27 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 28 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. Figure 4.14 Spot-check Record list If Continuos Record is selected, then the screen shows the Continuos Record list, as shown in figure 4.15, press Up/Down The corresponding User and User ID for the selected record
User Manual for Handheld Pulse Oximeter 29 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. Figure 4.15 Continuos record---List The corresponding User and User ID for the selected record
User Manual for Handheld Pulse Oximeter 30 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. SpO2 trend graph PR trend graph The corresponding User and User ID for the selected record Recording time
User Manual for Handheld Pulse Oximeter 31 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. Refer to the instruction in ―Oximeter Data Manager User Manual‖for detailed operation. Figure 417 Data uploading screen  During data uploading, the user can not do any operation on the oximeter.
User Manual for Handheld Pulse Oximeter 32 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. SpO2 Measurement Transducer: dual-wavelength LED sensor with wavelength: Red light: 663 nm, Infrared light: 890 nm. Maximal average optical output power: ≤ 2mW Display range: 35~100% Measuring accuracy: Arms is not greater than 3% for SpO2 range from 70% to 100% *NOTE: Arms is defined as root-mean-square value of deviation according to ISO 80601-2-61. 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~240bpm Accuracy: ±2bpm or ±2% (whichever is greater) Over-limit setting range: 25bpm~250bpm E. Data update period
User Manual for Handheld Pulse Oximeter 33 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. Operating Environment Operating Temperature: 5°C ~40°C Operating Humidity: 15%~93% Atmospheric pressure: 70kPa~106kPa Note: portable and mobile RF communications equipment may affect the performance of the Oximeter. I. Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.5%. J. Resistance to interference of surrounding light: The difference between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than ±1%. K. Dimensions: 158 mm (L) × 73 mm (W) × 25 mm (H) Net Weight: about 230g (including battery) L. Classification Type of protection against electric shock: Internally powered equipment and Class II. Degree of protection: Type BF applied parts.
User Manual for Handheld Pulse Oximeter 34 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%.  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. 6.2 Over-limit indication sound mute setting  During the measurement, if the over-limit indication sound is set to on, short time press Mute/Right key(" "), then the over-limit indication sound will mute for 90 seconds, but the over-limited value still keeps blinking. At this moment, the speaker volume icon becomes " ". If this alert event persists over 90 seconds, then the over-limit indication sound will be activated again.  During the measurement, if the probe is off or disconnected, the message "Check Probe" shows on the display screen. The alert sound starts (interval is 5 seconds) and lasts for about 3 minutes. If the probe is still off, the Oximeter will power off automatically.
User Manual for Handheld Pulse Oximeter 35 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. If 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.
User Manual for Handheld Pulse Oximeter 36 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.  The recommended storage environment of the device: Ambient temperature: -20ºC ~60ºC Relative humidity: 10%~95% Atmospheric pressure: 50kPa~107.4kPa Storage and Transportation between uses: – 25℃ without relative humidity control; and + 70 ℃ at a relative humidity up to 93% (non-condensing).  The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its life cycle. However, if it is necessary to verify its accuracy routinely, the user can do the verification by means of SpO2 simulator, or it can be done by the local third party test house. 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 37 9 Troubleshooting Trouble Possible Reason Solution Unstable SpO2 and Pulse Rate display 1. The finger is not placed far enough inside. 2. The finger is shaking or the patient is moving. 1. Place the finger correctly inside and try again. 2. Reduce patient movement. Unable to measure Temperature 1. Temperature probe is not connected properly 2. Reinsert the probe into the device Device will not switch on 1. The batteries are drained or almost drained. 2. The batteries are not inserted properly. 3. The device is malfunctioning. 1. Recharge or change batteries. 2. Reinstall batteries. 3. Please contact the local service center. No Display 1. The device will power off automatically when there is no signal and no operation for 1 minute. 2. The batteries are almost drained. 1. Normal. 2. Recharge or change batteries. No Signal 1. Probe off or incorrect connection 2. Incorrect finger insert 3. Probe is damaged 1. Reconnect the probe 2. Reinsert the finger 3. Replace a new probe
User Manual for Handheld Pulse Oximeter 38 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. Q: Why do the display value of SpO2 and PR vary with time? A: The measured SpO2 and PR value changes in correspondence with the change of patient's physiological conditions. 5. Q: What to do if there is no SpO2 and PR reading? A: Do not shake the finger, and keep calm during the measurement. Please also avoid the oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously. 6. Q: How to confirm that the SpO2 reading is true or accurate? A: Hold breath for a while (50 seconds or more), if the SpO2 value significantly decreases, it means that the SpO2 reading truly reflects the physiological condition change. 7. Q: When to replace the batteries? A: The icon of low battery will appear on the screen when the battery voltages are low. By then, batteries need to be replaced. 8. Q: What to do if the oximeter is moistened or sprayed by water? A: Remove the batteries immediately and dry the oximeter completely with a hair dryer. 9. Q: What factors will affect the SpO2 accuracy? A:a) Intravascular dyes such as indocyanine green or methylene blue;
User Manual for Handheld Pulse Oximeter 39 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 proximal to the sensor; h) Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing; i) Low perfusion condition (Perfusion Index is small). Please contact the local distributor or manufacturer if necessary.
User Manual for Handheld Pulse Oximeter 40 Appendix I Key of Symbols Symbol Description Symbols on the screen %SpO2 The oxygen saturation PI% Perfusion Index bpm Pulse rate (Unit: beats per minute) Pulse bar graph Low battery voltage Battery is full Speaker mute icon Speaker volume icon SpO2 spot-check record memory full SpO2 continuous record memory full Temperature memory full Wireless transmission icon / (Pediatric/Adult) Patient type
User Manual for Handheld Pulse Oximeter 41 Symbol Description Symbols on the panels SpO2 SpO2 probe connector TEMP Temperature probe connector Power/Left Key Mode/Right Key Rotate-lock/Up Key Setting/Down Key Menu/Confirm key or Record/Back key CE mark SN 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
User Manual for Handheld Pulse Oximeter 42 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. SpO2 is an important physiological parameter to reflect the respiration function; it is calculated by the following method: SpO2 = HbO2/ (HbO2 +Hb)×100% HbO2 are the oxyhemoglobins (oxygenized hemoglobin), Hb are those hemoglobins which release oxygen. 2 Principle of Measurement Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its density or concentration. When the light with certain wavelength emits on human tissue, the measured intensity of light after absorption, reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes. Due to that oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, SpO2 can be determined. SpO2 measured by this oximeter is the functional oxygen saturation -- a percentage of the hemoglobin that can transport oxygen. In contrast, hemoximeters report fractional oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.
User Manual for Handheld Pulse Oximeter 43 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. The status of SpO2 can be determined in time by measurement and find the hypoxemia patient earlier, thereby preventing or reducing accidental death caused by hypoxia effectively. 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. 4 Factors affecting SpO2 accuracy (interference reason)  Intravascular dyes such as indocyanine green or methylene blue  Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight.  Vascular dyes or external used color-up product such as nail enamel or color skin care  Excessive patient movement  Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line  Exposure to the chamber with High pressure oxygen  There is an arterial occlusion proximal to the sensor  Blood vessel contraction caused by peripheral vessel
User Manual for Handheld Pulse Oximeter 44 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
User Manual for Handheld Pulse Oximeter 45 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. Emissions test Compliance Electromagnetic environment-guidance RF emissions CISPR 11 Group 1 The Oximeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Oximeter suitable for use in all establishments, including domestic establishments and those directly network that supplies buildings used for domestic purposes. Harmonic emissions IEC61000-3-2 N/A Voltage fluctuations/flicker emissions IEC61000-3-3 N/A
User Manual for Handheld Pulse Oximeter 46 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. Immunity test IEC60601 test level Compliance level Electromagnetic environment -guidance Electrostatic discharge(ESD) IEC61000-4-2 ±6 kV contact ±8kV air ±6 kV contact ±8kV air Floors should be wood, concrete or ceramic tile. if floors are covered with synthetic material, the relative humidity should be at least 30% Electrical fast transient/ burst IEC61000-4-4 ±2kV for power Supply lines ±1 kV for input/output lines N/A N/A Surge IEC 61000-4-5 ±1kV line (s) to line(s) ±2kV line(s) to earth N/A N/A
User Manual for Handheld Pulse Oximeter 47 Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle <40% UT (60% dip in UT) for 5 cycles <70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s N/A N/A Power frequency( 50Hz/60Hz) magnetic field IEC61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE : UT is the a.c. mains voltage prior to application of the test level. Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity 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 electromagnetic environment.
User Manual for Handheld Pulse Oximeter 48 Immunity test IEC60601 test level Compliance level Electromagnetic environment -guidance Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz N/A 3 V/m 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. Recommended separation distance d=1.2P d=1.2P80MHz to 800MHz d=2.3P800MHz to 2.5GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). b Field strengths from fixed RF transmitters, as
User Manual for Handheld Pulse Oximeter 49 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 50 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. If the measured field strength in the location in which The Oximeter is used exceeds the applicable RF compliance level above, The Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. Table 4 Recommended separation distances between portable and mobile RF communication the equipment The Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Oximeter as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W(Watts) Separation distance according to frequency of transmitter M(Meters) 150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz 0,01 N/A 0.12 0.23 0,1 N/A 0.38 0.73
User Manual for Handheld Pulse Oximeter 51 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. NOTE 1 : At 80 MHz and 800 MHz, the separation distance for 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. Caution: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -Reorient or relocate the receiving antenna. -Increase the separation between the equipment and receiver. -Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -Consult the dealer or an experienced radio/TV technician for help.
User Manual for Handheld Pulse Oximeter 52 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. RF Exposure The equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
User Manual for Handheld Pulse Oximeter 53 Quality Inspection Certificate

Navigation menu