FCC ID: WWIMD300C208 Fingertip Pulse Oximeter

MD300C208 Fingertip Pulse Oximeter USER MANUAL Ver2.0C208 General Description Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity, compounded with oxygen, by all combinative hemoglobin

(Hb) capacity in blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a very important parameter for the Respiratory Circulation System. Many respiratory diseases can result in oxygen saturation being lowered in human blood. Additionally, the following factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by Anesthesia, Intensive Postoperative Trauma, injuries caused by some medical examinations. That situation might result in light-headedness, asthenia, and vomiting. Therefore, it is very important to know the oxygen saturation of a patient so that doctors can find problems in a timely manner. The fingertip pulse oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. It has been proven in clinical experiments that it also features high precision and repeatability. Measurement Principle Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 940nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeters display through process in electronic circuits and microprocessor shown on the oximeters display through electronic circuits and a microprocessor. Diagram of Operation Principle 1. Red and Infrared-ray Emission Tube 2. Red and Infrared-ray Receipt Tube Precautions For Use 1 Before use, carefully read the manual. 2 Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU). 3 Pulse Oximeters require sufficient blood flow to obtain proper readings. Poor blood circulation can result in inaccurate readings. If your hands are cold or you have poor circulation, warm your hands by rubbing them together or use another method before attempting to obtain a reading. A tourniquet, blood pressure cuff or other blood flow hindrances may also result in inaccurate readings. 4 Do not use the fingertip pulse oximeter in an MRI or CT environment. 5 Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous monitoring. 6 Do not use the fingertip pulse oximeter in an explosive atmosphere. 7 The fingertip pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. 8 In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device 9 Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not 10 Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, should be less than half an hour. intended for sterilization. including batteries. 11 This equipment complies with IEC 60601-1-2:2007 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. 13 This equipment is not intended for use during patient transport outside the healthcare facility 14 This equipment should not be used adjacent to or stacked with other equipment. 15 It may be unsafe to use accessoriesdetachable 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 These materials that contact with the patients skin contain medical silicone and ABS plastic enclosure are all pass the ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity. 17 When the signal is not stable, the reading may inaccurate. Please do not reference. Rx only: Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Contraindication It is not for continuous monitoring. Inaccurate measurements may be caused by 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin). Intravascular dyes such as indocyanine green or methylene blue. High ambient light. Shield the sensor area if necessary. Excessive patient movement. High-frequency electrosurgical interference and defibrillators. Venous pulsations. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. The patient is in cardiac arrest or is in shock. Fingernail polish or false fingernails. Weak pulse quality (low perfusion). Low hemoglobin. Product Features Simple to operate and convenient to carry. Small volume, light weight and low power consumption. Dual color OLED displays SpO2, PR, PI, Pulse bar, and waveform. 2 display direction. 2pcs AAA-size alkaline batteries; battery-low indicator. 1 2 3 4 5 6 Wireless Bluetooth for data transmission. 7 When no or low signal is detected, the pulse oximeter will power off automatically in 8 seconds 8 Compatible with iChoicelife App. Intended Use Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin

(SpO2) and pulse rate of adult and pediatric patients in hospitals, hospital-type facilities. Operation Instructions 1 2 3 4 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 5 After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode. There are 2 display directions and 2 displayed parameters shown as follows:

Notes:

1. 2. Short press the power button to switch the screen display orientation. Long press the power button to switch the displayed parameters (SpO2&PR, SpO2&PI). Data Transmission Turn on the device, the Bluetooth icon is flashing. After sync successfully, the Bluetooth icon is light on. Or else the Bluetooth icon still in the flashing status. When you turn off the device, the Bluetooth will break automatically. The current measurement will transmit to the App automatically. After data transmission successfully, the measurement flashing for 8s, then the device will power off automatically power off. If there is no Bluetooth connection over 1min, the device will power off automatically and the data will not be stored. If there is no digit appear, the device will power off automatically. 3. Notes:

1. With the Bluetooth 4.0 to transmit the data to App. 2. The transmission distance is 10m at most. Battery Installation Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage may be caused to the oximeter. Slide the battery door cover horizontally along the arrow shown as the picture. Please remove the batteries if the pulse oximeter will not be used for long periods of time. Please replace the battery when the power indicator starting flickering. Using the Lanyard Thread thinner end of the lanyard through the hanging hole. Thread thicker end of the lanyard through the threaded end before pulling it tightly. 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 strangulation due to excessive length. the lanyard which is tied to the oximeter may cause 1. 2. 1. 1. 2. 2. Notes:

Warnings!

Maintenance and Storage Replace the batteries in a timely manner when low voltage lamp is lighted. Clean surface of the fingertip 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 -20~+55 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 the fingertip pulse oximeter Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft cloth dampened with 70%

isopropyl alcohol. Also clean the being tested finger using alcohol before and after each test. Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to dry thoroughly before reuse. The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries. The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one measurement. Stop using and contact local service center if one of the following cases occurs:

An error in the Possible Problems and solutions is displayed on screen. 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. 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 9919:2005, 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 Fingertip 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. Specifications 1. Display Type OLED display 2. SpO2 Measurement range: 70%~100%

Accuracy: 70%~100%: 2%; 0%~69% no definition Resolution: 1%

ARMS Value Analysis Item

#pts Bias ARMS 70--100 90--100 80--<90 70--<80 231 0.03 1.07 82

-0.06 0.92 89 0.07 1.13 60 0.12 1.18 Bland-Altman plot analysis of sampled data points on all subjects as below 3. Pulse Rate Measure range: 30bpm~250bpm Accuracy: 30bpm~99bpm, 2bpm; 100~235bpm, 2%

Resolution: 1bpm 4. PI Measure range: 0.2%~20.0%

Accuracy: 0.2%~1.0%, 0.2digits; 1.1%~20.0%, 20%

Resolution: 0.1%

5. Probe LED Specifications Wavelength 6602nm 94010nm Radiant Power 1.8mW 2.0mW RED IR 6. Power Requirements Two AAA alkaline Batteries Power consumption: Less than 30mA Battery Life: Two AAA 1.5V, 800mAh alkaline batteries could be continuously operated as long as 28 hours. 7. Environment Requirements Operation Temperature: 5~40 Storage Temperature: -20~+55 Ambient Humidity: 80% no condensation in operation; 93% no condensation in storage Atmosphere pressure: 86kPa~106kPa 8. Equipment Response Time As shown in the following figure. Response time of slower average is 12.4s. 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 The application part is rubber inside of the Pulse Oximeter;

According to the degree of protection against ingress of water: IPX1 According to the mode of operation: CONTINUOUS OPERATION FCC Declaration 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. 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. Note: This product 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 product 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 product 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. Declaration Guidance and Manufacturers declaration electromagnetic emissions-For all EQUIPMENT and SYSTEMS Guidance and Manufacturers declaration - electromagnetic emission The MD300C208 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of MD300C208 Pulse Oximeter should assure that it is used in such an environment. Emission test RF emissions CISPR 11 Compliance Group 1 Electromagnetic Environment guidance The MD300C208 Pulse 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. The pulse Oximeter (MD300C208) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Class B Not Applicable Not Applicable Guidance and Manufacturers declaration electromagnetic immunity-For all EQUIPMENT and SYSTEMS Guidance and Manufacturers declaration - electromagnetic immunity The MD300C208 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the MD300C208 Pulse Oximeter should assure that it is used in such an environment. Immunity test Electromagnetic Environment guidance test IEC 60601 level

+/- 6kV contact

+/- 8kV air Compliance Level

+/- 6kV contact

+/- 8kV air 3A/m 3A/m Electrostatic Discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment. Guidance and Manufacturers declaration electromagnetic immunity-

For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufacturers declaration - electromagnetic immunity 60601 The MD300C208 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the MD300C208 Pulse Oximeter should assure that it is used in such an environment. Immunity Electromagnetic Environment guidance test Radiated RF IEC 61000-4-3 Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter (MD300C208), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance IEC test level 3 V/m 80 MHz 2.5 GHz Compliance Level 3 V/m to 80 MHz to 800 MHz 800 MHz to 2.5 GHz 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 meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with 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 structures, objects and people. a Field strengths from fixed transmitters, such as base station 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, an electromagnetic site survey should be considered. the measured field strength in the location in which the Pulse Oximeter (MD300C208) should be observed to verify normal operation. If abnormal performance is observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse Oximeter (MD300C208). b Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m If Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS - For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING portable and mobile RF communications equipment and Pulse Oximeter (MD300C208) Recommended separation distances between The Pulse Oximeter (MD300C208) is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter (MD300C208) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter (MD300C208) as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 800 MHz to 2.5 GHz 80 MHz to 800 MHz 0.01 0.1167 0.2334 0.3689 1.1667 3.6893 11.6667 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated 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. Possible Problems and Solutions 0.7378 2.3334 7.3786 23.3334 Problems SpO2 or PR can not be shown normally Possible reason 1. Finger is not inserted correctly 2. Patients SpO2 value is too low to be measured SpO2 or PR is shown unstably The oximeter cannot be powered on 1. Finger might not be inserted deep enough. 2. Excessive patient movement 1. No battery or low power of battery 2. Batteries might be installed incorrectly 3. The oximeter might be damaged 1. The product is automatically powered off when no signal is detected longer than 8 seconds 2. The battery power is too low to work 1. Err 3 means the red emission LED is damaged 2. Err 4 means the infra-red emission LED is damaged Solution 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 calmness 1. Please replace batteries 2. Please reinstall the batteries 3. Please contact with local customer service centre 1. Normal 2. Replace the batteries 1. Check the red emission LED 2. Check the infra-red emission LED Err 6 means the screen is failure Err 7 means all the emission LED or reception diode is damaged. Please contact with local customer service centre Please contact with local customer service centre Symbol Definitions Symbol Definition Type BF applied part. Symbol Definition Attention Protected against dripping water. SpO2 Oxygen saturation PR bpm Pulse rate (BPM) Low power indication No SpO2 Alarm SN Serial No. Storage temperature and relative humidity Manufacturers information Bluetooth indication Follow instruction for use Date of Manufacture Indicate the signal is not stable Notes:

1. 2. The illustrations used in this manual may differ slightly from the appearance of the actual product. The specifications are subject to change without prior notice. Applicable Models MD300C208, MD300C218, MD300C228, MD300C298, MD300C2B8, MD300C2D8, MD300C2F8 Beijing Choice Electronic Technology Co.Ltd. Room 4104, No. A12 Yuquan Road Haidian District 100039 Beijing PEOPLES REPUBLIC OF CHINA ALL RIGHTS RESERVED Version Ver2.0C208 Issue Date: April 28, 2014 Indication lamps are suddenly off Error3 or Error4 is displayed on screen Error 6 Error7 is displayed on screen