Pulse Oximeter USER MANUAL General Description Oxygen binds to hemoglobin in red blood cells when moving through the lungs. It is transported throughout the body as arterial blood. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage (%) of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. A pulse oximeter also measures and displays the pulse rate at the same time it measures the SpO2 level. Measurement Principle Intended Use Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light;
the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. Product Features Simple to operate and convenient to carry. Small volume, light weight and low power consumption. Dual color LCD displays SpO2, PR, PI, and Pulse bar. 7 display modes. Level 1-5 adjustable brightness. 2pcs AAA-size alkaline batteries; real-time battery status indication. Wireless Bluetooth for data transmission. The device will power off automatically in 8 seconds when Finger out is displayed. Compatible with iOS or Android App. The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. Operation Instructions 1 2 3 4 5 Install two AAA batteries according to the Battery Installation instructions. Place one of your fingers into the rubber opening of the pulse oximeter. Press the switch button one time on front panel to turn the pulse oximeter on. Keep your hands still for the reading. Do not shake your finger during the test. It is recommended that you do not move your body while taking a reading. Read the data from the display screen. The oximeter is designed with 7 display modes, as below, the first one is the default mode. Short press on the power button to switch between the 7 modes when the device is powered on. Understanding the display:
Diagram of Operation Principle 1. Red and Infrared-ray Detector 2. Red and Infrared-ray Light Source Precautions for Use 1. Before use, carefully read the manual. 2. Operation of the pulse oximeter may be affected by the use of an electrosurgical unit (ESU). 3. The pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement. 4. Do not use the pulse oximeter in an MRI or CT environment. 5. Do not use the pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous monitoring. 6. Do not use the pulse oximeter in an explosive atmosphere. 7. The pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with 8. other methods of assessing clinical signs and symptoms. In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device should be less than half an hour. 9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The 10. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device device is not intended for sterilization. components, including batteries. 11. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and/or systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. 12. Portable and mobile RF communications equipment can affect medical electrical equipment. The portable and mobile RF communications equipment should be used no closer than 30cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 13. This equipment is not intended for use during patient transport outside the healthcare facility. 14. The patient is an intended operator. All functions of the device can be safely used by the patient. 15. It may be unsafe to:
use accessories, detachable parts and materials not described in the instructions for use interconnect this equipment with other equipment not described in the instructions for use disassemble, repair or modify the equipment 16. The material that contact with the patients skin has passed the ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity. 17. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 18. The use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 19. When the signal is not stable, the reading may be inaccurate, please do not refer. 20. The material of the device has no nature latex. 21. The pulse oximeter equipment is calibrated to display functional oxygen saturation. 22. The waveform we provide is normalized. 23. Do not modify this equipment without authorization of the manufacturer. 24. The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist the users appropriately trained personnel to repair those parts of the equipment designated by the manufacturer to be repairable. 25. Stop using and contact local service center if one of the following cases occurs:
Any of the problems in the Possible Problems and solutions cannot be solved. The oximeter cannot be powered on in any case and not the reasons of battery. There is a crack on the oximeter or damage on the display resulting readings cannot be identified;
the spring is invalid; or the key is unresponsive or unavailable. 26. Aging infrared-ray detector or insufficient battery level may affect the equipment performance. Please follow the instructions in the manual to maintain the device. 27. Please contact the manufacturer for any question about the usage or maintenance. Rx only: Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Contraindication Not yet found. Inaccurate Measurements May Be Caused By 1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin). 2. Intravascular dyes such as indocyanine green or methylene blue. 3. High ambient light. Shield the sensor area if necessary. 4. Excessive patient movement. 5. High-frequency electrosurgical interference and defibrillators. 6. Venous pulsations. 7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. 8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. 9. The patient is in cardiac arrest or is in shock. 10. Fingernail polish or false fingernails. 11.Weak pulse quality (low perfusion). 12. Low hemoglobin. DATA TRANSMISSION: transfer measurements to iChoice APP 1. Download iChoice APP from the APP marketplace in your smartphone and install the APP. 2. Register a user account in the APP and log in. 3. Connect the APP with the device via Bluetooth (select Pulse Oximeter on the APP homepage>choose device model>tap Connect the device). 4. Upload your measurement data to the APP (tap in the upper-right corner and read How to Use for detailed steps to use the APP). Notes: The Bluetooth icon stops flashing and stay still on the display when the oximeter is connected with APP. The Bluetooth communication range is 10 meters at most. The ? appears on the display when the signal is not stable. The readings are potentially incorrect. Please keep your hand still and retry. The display will show Finger out if no finger is detected. Automatic shutdown happens after no operation for 8 seconds. Settings 1. Press and hold the power button to enter Settings menu when the unit is powered on. 2. Press the power button to select between the setting items, and then press and hold the power button to select the option behind the selected item. Work Mode: to set up the work mode of Bluetooth as Real-time or Spot-check.
-Spot-check: The stable readings are transferred to the App automatically. The measurements will flash for 8s and then the device will automatically power off.
-Real-time: The data are uploaded to the App in real-time. The device will power off automatically in 8 seconds when Finger out is displayed. Language: to change the display language to English or Chinese Brightness: to adjust screen brightness from 1-5. Level 5 is the default. Reset: to restore default settings Exit: to return to measuring interface. Without any operation, the device automatically enters measurement mode in 8 seconds. Battery Installation 1. Slide the battery door cover along the arrow and open it. 2. Insert two AAA batteries into the battery in correct polarities. 3. Close the battery door cover. Notes: Please make sure the battery polarities are matched with the +/- signs on the compartment. Please remove the batteries if the pulse oximeter will not be used for a long time. Please replace the battery when the low power indicator starts flickering. Using the Lanyard 1. Thread thinner end of the lanyard through the hanging hole on the device. 2. Thread thicker end of the lanyard through the threaded end and tighten. Warnings!
Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards. Do not hang the lanyard from the devices electrical wire. Please notice that the lanyard which is tied to the oximeter may cause strangulation due to excessive length. Maintenance and Storage Possible Problems and Solutions Replace the batteries in a timely manner when low voltage lamp is lighted. Clean surface of the oximeter before it is used in diagnosis for patients. Remove the batteries if the oximeter is not operated for a long time. It is best to store the product in -25~+70 and 93% humidity. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage. Dispose of battery properly; follow any applicable local battery disposal laws. 1. 2. 3. 4. 5. 6. Cleaning and disinfecting the device It is recommended to clean and disinfect the silicone touching the finger inside of device with a soft cloth dampened with recommended alcohol of 70% isopropyl or 70% ethanol before and after each use. Excessive disinfection may cause damage to the device and is therefore not recommended for this device unless otherwise indicated in your hospitals servicing schedule. Do not pour or spray liquids onto the device and do not allow any liquid to enter any openings in the device. Allow the device to dry thoroughly before reuse. Caution: Never use EtO (ethylene oxide) or formaldehyde for disinfection. The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one measurement. The Oximeter requires no routine calibration or maintenance other than replacement of batteries. Specifications 1. Display Type LCD display 2. SpO2 Measurement range: 70%~100%
Accuracy: 70%~100%: 2%; 69% no definition Resolution: 1%
Note: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establish the SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70%~100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical EquipmentParticular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. A functional tester is used to measure how accurately Pulse Oximeter is reproducing the specified calibration curve and the PR accuracy. The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3. 3. Pulse Rate Measure range: 30bpm~250bpm Accuracy: 30bpm~99bpm, 2bpm; 100~250bpm, 2%
Resolution: 1bpm 4. Perfusion Index Measure range: 0.3%~20.0%
5. Probe LED Specifications RED Wavelength: 6603nm Radiant Power: 3.2mw IR Wavelength: 90510nm Radiant Power: 2.4mw
(NOTE: The information about wavelength range can be especially useful to clinicians). 6. Power Requirements Two AAA alkaline Batteries 7. Environment Requirements Operation Temperature: 5~40 Power consumption: Less than 40mA Problems Possible reason Solution SpO2 or PR cannot be shown normally. 1. Finger is not inserted correctly. 2. Patients SpO2 value is too low to be measured. SpO2 or PR is shown unstably. 1. Finger might not be inserted deep enough. 2. Excessive patient movement. 1. Retry by inserting the finger. 2. There is excessive illumination. 3. Try some more times. If you can make sure no problem exist in the product, please go to a hospital timely for exact diagnosis. 1. Retry by inserting the finger. 2. Be calm. The oximeter cannot be powered on. 1. No battery or low power of battery. 2. Batteries might be installed incorrectly. 3. The oximeter might be damaged. 1. Please replace batteries. 2. Please reinstall the batteries. 3. Please contact local customer service center. Indication lamps are suddenly off. Err 7 is displayed on screen. 1. The product is automatically powered off when no signal is detected longer than 8s. 2. The battery power is too low to work. Err 7 means all the emission LED or reception diode is damaged. Symbol Definitions 1. Normal. 2. Replace the batteries. Symbol Definition Symbol Definition Type BF applied part Attention IP22 Protected against dripping water
%SpO2 Oxygen saturation PR bpm Pulse rate (BPM) Low power indication No SpO2 Alarm Serial No. Storage temperature and relative humidity Follow instruction for use Manufacturers information Date of Manufacture Bluetooth indication
Indicate the signal is not stable Waste electrical and electronic equipment Medical device Storage Temperature: -25~+70 Ambient Humidity: 15%~93% no condensation in operation;
93% no condensation in storage/transport The device conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard. Essential performance is defined as SpO2 accuracy and pulse rate accuracy or an indication of abnormal operation. Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the intended use. If issues are experienced, move the device away from the source of electromagnetic disturbances. Electromagnetic Compatibility Atmosphere pressure: 70kPa~106kPa Notes: When the ambient temperature is 20C, it is required 6 hours for the equipment to warm from the minimum storage temperature or 4 hours to cool from the maximum storage temperature between uses until it is ready for its intended use. 8. Equipment Response Time: as shown in the following figure, average data update period is 8s. Table 1: Electromagnetic Emissions Limits and Compliance Emissions Test RF Emissions CISPR 11 Note: Harmonic Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3) are not applicable. Group 1, Class B Compliance Please contact local customer service center. 9. Classification According to the type of protection against electric shock: Internally powered equipment According to the degree of protection against electric shock: Type BF applied part (applied part: the rubber hole of the device) According to the degree of protection against ingress of water: IP22 According to the mode of operation: continuous operation Clinical Study Summary The following details are provided to disclose actual performance observed in the clinical validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-Altman plot of data are shown as follows:
FCC Declaration FCC ID: WWIMD300C228 ARMS Value Analysis Statement Item
#pts Bias ARMS 70--100 227 0.99 1.80 90--100 91 0.73 1.16 80--<90 81 1.44 2.04 70--<80 55 0.74 2.21 70-<90 136.00 1.16 2.11 Table 2: Electromagnetic Immunity Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2 Rated power Frequency Magnetic Fields IEC 61000-4-8 Radiated RF IEC 61000-4-3 Compliance 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 30 A/m 50Hz and 60 Hz 80 MHz 2.7 GHz 380 390 MHz 430 470 MHz 704 787 MHz 800 960 MHz 1.7 1.99 GHz 2.4 2.57 GHz 5.1 5.8 GHz 10 V/m 80% AM 1kHz 27 V/m Pulse mod. 18Hz 28 V/m FM5Hz deviation 1kHz sine 9 V/m Pulse mod. 217Hz 28 V/m Pulse mod. 18Hz 28 V/m Pulse mod. 217Hz 28 V/m Pulse mod. 217Hz 9 V/m Pulse mod. 217Hz Note: Electrical Fast Transients (IEC 61000-4-4), Surge (IEC 61000-4-5), Voltage dips (IEC 61000-4-11), Conducted Immunity
(IEC 61000-4-6) are not applicable. Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 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. 1. One pulse oximeter 2. One lanyard 3. Two AAA batteries 4. One instruction manual Box Content Applicable Models MD300C208 MD300C228 Notes:
1. The illustrations used in this manual may differ slightly from the appearance of the actual product. 2. The specifications are subject to change without prior notice. Bland-Altman Plot Graphic ALL RIGHTS RESERVED Version: Ver1.0 Issue Date: December 08, 2021