FCC ID: 2AZ8H-6120-K01LX Fingertip Pulse Oximeter

Fingertip Pulse Oximeter Instructions for use NOTE Provides application tips or other useful information to ensure that you get the most from your product. 1.2 Symbol and Explanation Symbol Explanation Symbol Explanation Long-term alcohol people. 2.5 Appearance Digital tube oximeter Display screen (6 interfaces) Reminder Setting Limit Setup P/N: 1.28.0600-10 Version: 1.0 Release/Revision date: 2021-03 Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd NO.8, Shengchang West Road, Danyang Development Zone, Jiangsu Province, 212300, P.R.China Tel: +86-511-86375968 Fax: +86-511-86371668 E-mail: info@ konsung.com Website: www.konsung.com Statement Hereby, Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd., declares that this Fingertip Pulse Oximeter is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. Thanks for your purchasing fingertip pulse oximeter of Jiangsu Konsung Bio-M edical Science And Technology Co., Ltd.,

(hereinafter called Konsung"). Before using the pulse oximeter, please read this manual carefully for understanding the operation and maintenance of the oximeter. Konsung owns the rights to modify, update, and ultimately explain this manual. Konsung owns the copyrights of this manual. Without prior written consent of Konsung, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. Users operation failing to comply with this manual may result in malfunction or accident for which Konsung cannot be held liable. This manual is based on the maximum configuration and therefore some contents may not apply to your product. All illustrations and settings in this manual are for reference only, and the actual product shall prevail. Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by a specified trained personnel. Responsibility of the Manufacturer Konsung is responsible for the effects on safety, reliability and performance of this product, only if:

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Konsung authorized personnel;

The electrical installation of the relevant room complies with the applicable national and local requirements;

The product is used in accordance with the instructions for use. Upon request, Konsung may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which Konsung may define as user serviceable. Part 1 Safety precautions 1.1 Safety Information The user should pay attention to and abide by the basic safety information which was referred to in this Part. Warning Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury. Warning 1 The oximeter is not intended as a device used for treatment purposes. Ensure that the equipment is in normal working condition and operating environment before using. 2 Do not use the measuring data displayed on the pulse oximeter as the only basis for clinical diagnosis. The oximeter is intended only as an adjunct in patient assessment. It must be used with other methods of assessing clinical signs and symptoms or physician's diagnosis. 3 Do not open the shell of instrument; otherwise you may damage the equipment. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only. 4 Misapplication of the oximeter with excessive pressure for prolonged periods can induce pressure injury, check and change the applied site according to the different circumstances of the user while using oximeter for prolonged periods. It is recommended to check and change the applied site every 2 hours. 5 Check the integrity of the subjects skin, circulatory conditions and change the applied site. 6 The oximeter is not intended to use of infant and neonate. 7 High ambient light sources such as surgical lights

(especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. 8 Do not use the oximeter in situations where alarms required. The oximeter does not support alarms. 9 FUNCTIONAL TESTER cannot be used to assess ACCURACY. 10 The skin temperature is initially at 35C for each PULSE OXIMETER, the APPLIED PART temperature cannot exceed 41C. 11 The material that the pulse oximeter contacted to body is Non-toxic silica gel which meet the ISO 10993 requirements, so can be safety used. Users who are allergic to natural rubber latex cannot use this product. Caution 1 To ensure user safety, only use accessories and parts produced or recommended by Konsung. Otherwise, damage to the pulse oximeter can occur. 2 Do not use the oximeter near by the source of interference, such as mobile phones, radio transmitter, radiant heater, nebuliser or steam kettle. 3 Do not use degraded or loosened sensor, which can degrade performance of the oximeter or cause other problems. 4 Keep the oximeter surface dry and clean. Keep the oximeter away from corrosive chemicals, lint, dust, high temperature and humidity environment. 5 The operating temperature of the oximeter is 5C to 40C. If the ambient temperature exceeds the operating temperature range, the oximeter shall be left for at least 60 minutes before use. 6 The oximeter should be appropriately placed. Keep it from falling, strong vibration, pets, pests, children or other mechanical damage. 7 Do not spill liquid on the oximeter. Do not immerse the 8 Do not use the oximeter if the oximeter cannot achieve oximeter in liquid. satisfactory results. 9 At the end or its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. NOTE:

1 Check the oximeter before using. Do not use it if there is significant damage. 2 Too cold or too thin finger may affect the measurements;

fully insert your finger (index, middle and ring fingers are recommended) into the oximeter during measurement. 3 Avoid measuring SpO2 on extremities with an arterial catheter, or intravascular venous infusion line. 4 SpO2 waveform is not proportional to the pulse volume. The SpO2 waveform is normalized. 5 The pulse oximeter is calibrated to display functional oxygen saturation. reference only. 7 Fingernail polish or false fingernails may cause inaccurate SpO2 readings. 8 Never incinerate batteries or expose them to high temperatures. Refer to instruction manual/booklet Caution Type BF applied part Type BF applied part No alarm Battery indication Power on/off PR Pulse rate SpO2 Oxygen saturation of arterial hemoglobin Serial number WEEE symbol P/N Part number Batch number IP22 Date of manufacture Degree protection against ingress of liquids and dust Manufacturer Part 2 Product Introduction 2.1 Introduction Fingertip pulse oximeter is a device that uses non-invasive method to measure the blood oxygen saturation and pulse rate. It is based on the principle of differential wavelength absorption. The oximeter is suitable for family, clinic, oxygen bar, sports health (use before and after exercise is not recommended for use during exercise), community health and other ranges. This product is not suitable for continuous monitoring of patients. Oxygen saturation is an important physiological parameter that characterizes the oxygen carrying capacity of blood. Many respiratory diseases can result in low oxygen saturation 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, vomiting and other symptoms, severe cases will be life-threatening. Therefore, it is very important to know the oxygen saturation of a patient so that doctors can find problems timely. 2.2 Intended Use and Contraindication Intended use: The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate of adult and child. Contraindication: none 2.3 Working Principle The principle is based on the different light absorption characteristics of hemoglobin and oxyhemoglobin in the blood, an experience formula of data process is established in red light and near-infrared light zones, two beams of different wavelength of lights can be focused onto human nail tip through sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on the display through process in electronic circuits and microprocessor. 2.4 Applications This device is suitable for the following people:

People with vascular disease, such as: coronary heart disease, hypertension, hyperlipidemia, cerebral thrombosis;

People with respiratory diseases, such as: asthma, trachitis, chronic bronchitis, chronic cor pulmonale, chronic obstructive pulmonary disease;

Old people above 60 years old People who works more than 12 hours a day;

People works on extreme exercise or under the alpine hypoxic environment;

1. Display screen 2. Bar graph icon: The number of segments indicates the pulse strength. 3. Pulse rate (PR): detected pulsations per minute. 4. Battery capacity indicator Low capacity: the battery icon flashes;

Full capacity: the battery icon is not displayed. 5. Power On/Off button Press this button to start oximeter. Press this button to change the reading 180 after power on or during measuring. 6. SpO2: percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin. Display screen (2 interfaces) Without data With data Interfaces Interface 1 Interface 2 Icon description:

%SpO2: means blood oxygen saturation;

: means pulse rate. OLED oximeter 4 6 5 6 7 1 2 3 4 5 1 2 3 4 1. Two-color OLED display 2. Pleth waveform: visual indication of patients pulse. 3. Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the quality of SpO2 measurement. 4. Power On/Off button Press this button to start oximeter. Press this button to change the reading 90 after power-on or during measuring. Press this button 2 seconds to enter the setting interface when the oximeter is on. In the setting interface, press this button to In the Setting interface, press and hold this button 2 seconds to confirm the setting. 5. SpO2: percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin. 6. Battery capacity indicator Full capacity, the middle part indicates the capacity. Battery extremely low, change new battery. 7. Pulse rate (PR): detected pulsations per minute. switch Settings. Setting interface Measure interface Interface 1 Interface 2 Interface 3 Interface 4 Interface 5 Interface 6 Without data With data Icon description:

%SpO2: means blood oxygen saturation;

PR bpmmeans pulse rate;

PI%: means perfusion index;

bar graph icon;

pulse intensity histogram. Part 3 Unpacking and Storage 3.1 Open-case inspection Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us. If the packing case is intact, open the package and remove the oximeter and accessories carefully. Do not use it if the oximeter has mechanical damage. Check whether there is any damage to the surface of the oximeter such as notches, dents, abrasions and so on. Check whether the components are missing according to packing list. 3.2 Storage The oximeter is manufactured with precision parts. Do not place the oximeter in the following places:

Easy to splash;

With Direct sunlight, high temperature, humidity, dust, and corrosive gas;

Tilt, generate vibration and impact;

Store chemicals or corrosive gases. Part 4 Operation Instructions 4.1 Using Oximeter 1. Remove the battery cover, and insert the two AAA batteries following polarity markings indicated inside of the battery compartment, then reposition the cover. 2. Hold the oximeter clamp, place your finger into the oximeter as shown below. For best results, make sure the finger is centered within the oximeter. 3. Press the ON/OFF button to turn the oximeter on. The measure interface is shown. 4. The measured value is displayed after completing the test. NOTE:

1 Index finger, middle finger or ring finger are recommended for measurement. 2 The screen shows --- if oximeter is faulty or the signal quality is poor. 3 The user's hand should be relaxed (e.g. lying on a flat surface), and do not shake the finger, hand or body during the measuring. 4 Tape or other light obstructions around the applied site may affect the accuracy of SpO2 and pulse rate. 5 Cold hands/fingers could affect reading accuracy. 6 The oximeter will shut down if no any actions within 10 7 8 seconds after it turning on. If a reading does not appear within 10 seconds, remove the users finger slightly, or twist and/or shift the finger and try again. If a second try is unsuccessful, repeat the measuring process on a smaller finger. The following factors may influence the accuracy of measurements:

Ambient light (including photodynamic therapy) Physical movement (patient and imposed motion) Diagnostic testing Low Perfusion;

Electromagnetic interference, such as MRI environment HF surgical equipment Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin

(MetHb) Presence of certain dyes, such as methylene and indigo carmine Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor. Drop of arterial blood flow to immeasurable level caused by shock, anemia, low temperature or vasoconstrictor. 4.2 Reminder Function For the OLED oximeter: when the SpO2 or PR value exceeds the set limit, the measured value flashes to remind the user that the SpO2 or PR is abnormal. For the digital tube oximeter: when the SpO2 is less than 90%, PR is less than 50bpm or greater than 140bpm, the measured value flashes to remind the user that the SpO2 or PR is abnormal. 4.3 Settings (for OELD oximeter) Reminder Setting Press and hold power on/off button 2 seconds after turning on the oximeter to enter the Reminder Setting interface. Press the power on/off button to select the setting item, *

will jump to the current item, you can select Beep, Auto Direction, Sound Reminder, Brightness, Restore or Exit. Press the power on/off button to switch options, and press and hold power on/off button to confirm the setting. On means open, Off means closed. Turn on/off Beep In Reminder Setting interface, press power on/off button to select Beep, * appears on Beep, then press and hold power on/off button to switch between On and Off. The default is Off. Turn on/off Auto Direction In Reminder Setting interface, press power on/off button to select Auto Direction, * appears on Auto Direction, then press and hold power on/off button to switch between On and Off. The default is On. Turn on/off Sound Reminder In Reminder Setting interface, press power on/off button to select Sound Reminder, * appears on Sound Reminder, then press and hold power on/off button to switch between On and Off. The default is On. Screen Brightness Setup In Reminder Setting interface, press power on/off button to select Brightness, * appears on Brightness, then press and hold power on/off button to set brightness level. Brightness level is adjusted from 1 to 10, the default is 4. Caution 6 The pictures and interfaces in this manual are for Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. Restore the initial settings In Reminder Setting interface, press power on/off button to select Restore, * appears on Restore, then press and hold power on/off button to restore all initial settings. Limit Setup Press and hold power button to enter the Remind Setting interface after turning on the oximeter, and press the power button again to enter the Limit Setup interface, as shown below. Press power button to select the setting item, * will jump to the current item, you can select SpO2 Hi (high limit of SpO2), SpO2 Lo (low limit of SpO2), PR Hi (high limit of PR), PR Lo (low limit of PR), +/- (value increase/ value decrease), or Exit. Press the power on/off button to switch options, and press and hold power on/off button to confirm the setting. Exit Setting In the setting interface, press the switch button to select Exit, * appears on Exit, press and hold power button to save settings and exit the setting interface. In the setting interface, if there is no operation within 30 seconds, the oximeter will automatically save the setting and exit the setting interface. 4.4 Data transmission (only applicable to some models) Some OLED oximeters are configured Bluetooth module, which can send measurement data to the mobile phone through Bluetooth transmission, and users can install an APP on the mobile phone to view the measurement data. Part 5 Accessories Use only accessories specified in this manual. Using other accessories may cause damage to the pulse oximeter. Or the performance of pulse oximeter cannot meet the specifications claimed in this specification. The accessory material that contacts the user or other personnel has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. One lanyard One User Manual One Quality Certificate Part 6 Maintenance The oximeter can be used for 5 years. Keep the oximeter and accessories free of dust and dirt, and follow these rules:

1) Please clean the equipment before use according to Part 7; Remove the batteries inside the battery cassette if the equipment will not be operated for more than 30 days. 2) Battery polarities should be correctly installed, otherwise, damage may be caused to the oximeter. 3) Replace the batteries when the low battery indicator 4) Battery may leak or explode if used or disposed of says it is necessary. improperly. 5) It is recommended that the oximeter should be kept in a dry environment with no corrosive gases and good ventilation. Storing the oximeter improperly will affect its lifespan and damage the equipment. 6) It is best to preserve the product in a place where the temperature is between -20C to 60C and the relative humidity is less than 95%. 7) The packed equipment can be transported by ordinary conveyance. The equipment may not be transported with toxic, harmful, or corrosive materials. 8) Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations. NOTE:

1 Do not attempt to disassemble the oximeter or repair it unless you are trained personnel. 2 Necessary maintenance or calibration must be performed by qualified service personal ONLY. 3 Users are NOT permitted to maintain the equipment by themselves. 4 There are NO replaceable components in the equipment. Part 7 Cleaning and Disinfection 7.1. Cleaning The recommended cleaning agent is water. 1. Shut down the oximeter and remove the batteries. 2. Clean the oximeter with cotton or a soft cloth moistened with water. 3. After cleaning, wipe off the water with a soft cloth. 4. Allow the oximeter to air dry. 7.2 Disinfection Recommended disinfectants are Ethanol 75%, isopropanol 70%. 1. Shut down the oximeter and remove the batteries. 2. Clean the pulse oximeter as instructed in section 7.1. 3. Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants. 4. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with water. 5. Allow the oximeter to air dry. Caution 1 Never immerse or soak the pulse oximeter. 2 It is recommended that the pulse oximeter be cleaned and disinfected after every use as determined by your hospitals policy to avoid long term damage to the pulse oximeter. 3 Never use cleaning agents/disinfectants other than the 4 The sensor component is not cleaned and disinfected types recommended. during testing. 5 Do not disinfect the oximeter with high temperature, high pressure, gas vapor or liquid immersion. Clean and disinfect the oxygen meter according to the manufacturer's requirements. 6 Oximeters regular calibration and maintenance should be taken by qualified professionals. NOTE:

1 If you spill liquid on the equipment or accessories, wipe it clean immediately. If the oximeter does not work properly, contact us or your service personnel. 2 Never use EtO or formaldehyde for disinfection. Part 8 Product Specification Safety Specifications (classified according to IEC60601-1) External battery power supply device Type BF applied part IP22 Continuous Electric shock protection Degree of protection against electrical shock Degree of protection against ingress of liquid:

Operating mode Measurement Specifications SpO2 displayed range SpO2 accuracy1 PR displayed range PR accuracy 0%-100%

70% -100%, 2%;

0% - 69%: Not specified. 18bpm - 250bpm 25bpm -250bpm, 3bpm;

18bpm - 24bpm, Not specified. 0% - 20%

0.1%

<30s 8s Red light: 6603nm;

Infrared light: 9405nm

<30mW PI displayed range PI resolusion Data update period Data average time SpO2 sensor peak wavelength range2 M aximum photic output power 1 Sensor accuracy was obtained by performing controlled hypoxia studies on healthy, non-smoking adult volunteers

(according to ISO 80601-2-61). The SpO2 readings have been compared to CO-oximeter measurements on arterial blood saturation. To represent the general population, data from at least 10 subjects (male and female) with a wide range of skin color was taken to validate SpO2 accuracy. 2 The information about wavelength range and maximum optical output power of the light emitted by the oximeter sensor can be especially useful to clinicians, for example, clinicians performing photodynamic therapy. Note: Only 2/3 of measurements are expected to fall within the DECLARED RANGE of SpO2 ACCURACY. Physical Specifications Dimension 70 x 40 x 30mm (L x W x H) Weight Hardware specifications 60g (without battery) Display screen Display content Digital tube, 1.1"

OLED, 0.96"

Digital tube oximeter OLED oximeter Environmental Specifications Temperature Relative humidity (non--

condensing) SpO2, PR, battery icon, bar histogram SpO2, PR, battery icon, bar histogram, wavelength, PI Working 5C40C Transport and Storage

-20C60C 30%80%

10%95%

70106kPa 70106kPa Atmospheric pressure Power supply specification Battery Voltage 2 AAA alkaline batteries 3.0V 20 hours (2 new Nanfu batteries Operating time Network and RF Hardware Configuration CPU: HC32L130J8TA Operating system: no Memory: 64KB Flash, 8KB RAM Software Environment Keil uVision5 Transmission protocol: BLE 4.2 specification and custom communication protocol 2402-2480MHz Software environment update Data interface N/A

< 10dBm Bluetooth frequency range Maximum RF power Model and configuration table Model SONOSAT-K01R SONOSAT-K01W SONOSAT-K02R SONOSAT-K02W SONOSAT-K01SW SONOSAT-K02SW SONOSAT-K01SR SONOSAT-K02SR Digital tube

/ two direction Digital tube

/ two direction Screen SONOSAT-K01T SONOSAT-K02T OLED/ four direction SONOSAT-K01LT SONOSAT-K02LT OLED/ four direction OLED/ four direction OLED/ four direction SONOSAT-K01P SONOSAT-K02P SONOSAT-K01LP SONOSAT-K02LP Function SpO2, PR, Bar histogram, low battery prompt, automatic shutdown SpO2, PR, Bar histogram, low battery prompt, automatic shutdown, over-limit reminder, pulse beep SpO2, PR, Bar histogram, low battery prompt, automatic switch on/off, Pulse beep,over-

limit reminder,PI SpO2, PR, Bar histogram, low battery prompt, automatic switch on/off, Pulse beep,over-

limit reminder,PI, Bluetooth SpO2, PR, Bar histogram, low battery prompt, automatic switch on/off, Pulse beep,PI, Reminder setting, Limit setting, over-limit reminder, auto direction SpO2, PR, Bar histogram, low battery prompt, automatic switch on/off, Pulse beep,PI, Reminder setting, Limit setting, Bluetooth Part 9 Troubleshooting Trouble The oximeter can not enter to measure mode. Possible Causes The batteries are completely exhausted. Battery installation is incorrect. The oximeter may be broken. The oximeter will turn into sleep mode automatically if there is no signal in 10 seconds. The batteries are The display is suddenly off. Solution Replace new battery Check and correct the batteries installation. Contact the local distributor. Press power ON/OFF button to restart the oximeter. Replace new battery The SpO2 and Pulse Rate readings are unstable. completely exhausted. The luminescent or photoelectric window is sheltered by some object. Excessive movement. Stop moving finger, Check the luminescent and photoelectric window. 11.2 Electromagnetic Immunity-for all EQUIPMENT and SYSTEMS Guidance and manufactures 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 environment. The finger is not placed inside deep enough. Finger size is not within the recommended range. Excessive ambient light. Pulse rate value of the cyclical fluctuations. The SpO2 and PR are not displayed normally. Finger might not be inserted properly The patients SpO2 is too low to be detected. hand and body. Place the finger properly and try again. Change to another finger. Avoid the excessive light. The measurement is normal, and the patient has arrhythmia. Place the finger properly and try again. Try again, go to a hospital for a diagnosis if you are sure the oximeter works properly. Part 10 Warranty and Service The materials and processes used of manufacturing equipment meet the requirements. Konsung's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Konsung or repairs by people other than Konsung authorized personnel. The products are free to enjoy after-sales service within warranty period. But please beware, even during the warranty period, due to the following reasons the product needs repair, Konsung will be charged maintenance services, you need to pay for maintenance and parts costs:

Damage caused by mishandling during shipping. Subsequent damage caused by improper use or maintenance. Damage caused by alteration or repair by anyone not authorized by Konsung. Damage caused by non-normal use beyond the Original serial number tag or manufacturer logo is prescribed conditions;

removed or replaced;

Konsung can continue to provide toll maintenance services after the warranty expires. If you do not pay or delay the payment of maintenance costs, Konsung will temporarily suspend maintenance until you pay. If any questions in equipment operation, please contact the manufacturer or local agency. Part 11 EMC 11.1 Electromagnetic Emissions-for all EQUIPMENT and SYSTEMS Guidance and manufactures 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. Emission test Compliance Electromagnetic RF(Radio frequency) emissions CISPR 11 RF(Radio frequency) CISPR 11 Harmonic emissions IEC/EN 61000-3-2 Voltage fluctuations/

flicker emissions IEC/EN 61000-3-3 Group 1 Class B Class A Complies environment guidance 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. The oximeter is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Immunity test Electrostatic discharge

(ESD) IEC/EN 61000-

4-2 Electrical fast transient /burst IEC

/EN 61000-4-4 Surge IEC /

EN 61000-4-5 Power frequency

(50/60Hz) magnetic field IEC /EN 61000-

4-8 Voltage dips, short interruptions and voltage variations on power supply input lines IEC/EN 61000-

4-11 IEC/EN 60601 test level Complianc e level 8 kV contact 15 kV air 8 kV contact 15 kV air 2kV for power supply lines 1 kV for input

/output lines 1 kV differential mode 2 kV common mode 30A/m N/A N/A N/A N/A 30A/m, 50/60Hz Electromagnetic environment -

guidance 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 characteristic of a typical location in a typical commercial or hospital environment. 0 % UT, for 0.5 cycle

(100% dip in UT) 0 % UT, for 1 cycle

(100% dip in UT) 70 % UT, for 25/30 cycles

(30% dip in UT) 0 % UT, for 250/300 cycles

(100% dip in UT) N/A N/A NOTE: UT is the AC mains voltage prior to application of the test level. 11.3 Electromagnetic Immunity-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufactures declaration electromagnetic immunity The oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of oximeter should assure that it is used in such an environment. Compliance level Electromagnetic environment - guidance IEC/EN 60601 test level 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.7 GHz N/A 3 V/m Immunity test Conducted RF IEC/EN 61000-4-6 Radiated RF IEC/EN 61000-4-3 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 =

80 MHz-800 MHz 800 MHz-2.7 P2.1 P2.1 P3.2 d =

d =

GHz Where:

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). Field strengths from fixed RF transmitters, as 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. 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, an 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 reorienting or relocating the Oximeter. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. 11.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the oximeter 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) Separation distance according to frequency of transmitter(m) 80 MHz to 800 MHz 150 kHz to 80 MHz 800 MHz to 2.7 GHz d =

d =

d =

0.01 0.1 1 10 100 P2.1 N/A N/A N/A N/A N/A P2.1 0.12 0.38 1.2 3.8 12 P3.2 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 80MHz and 800MHz, 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. FCC Statement 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. NOTE: 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 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. WARNING: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.

Authority to Act as Agent Date: 8 June 2021 TUV Rheinland Group 762 Park Avenue Youngsville, NC 27596 To Whom It May Concern:

I appoint TUV Rheinland (Shenzhen) Co., Ltd. to act as our agent in the preparation of this application for equipment certification. | certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canadas regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TUV Rheinland Group, still resides with Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. / NO.8, Shengchang West Road, Danyang Development Zone, Jiangsu Province, 212300 P.R.China. For TCB applications, We certify that we are not subject t denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: 12 months By : Hox y on Haiyan Zhang L i

(Signature) (Print Name) Title : Engineer Telephone : +86-17722507195 Jiangsu Konsung Bio-Medical Science MaineMaltot And Technology Co.,Ltd,

(Company Name) QF094234 Page 1 of 1 Revision 0

Confidentiality Letter Date: 8 June 2021 Subject: Confidentiality Request for FCC ID: 2AZ8H-6120-KO1LX Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit

|_] Short Term (x) Permanent Block Diagrams x] Short Term External Photos Short Term [_] Permanent Internal Photos _] Short Term ><] Permanent Operation Description/Theory of Operation _] Short Term x] Permanent Part List/Tune-Up Procedure L_] Short Term (x) Permanent Schematics

] Short Term Test Setup Photos x] Short Term _] Permanent Users Manual Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-

1705. Sincerely, By: Hai your 2h Haiyan Zhang

(Signature/Title) (Print name)