Olive OLV-3 Operation & User’s Manual

use the machine. Issue Date: 2021.04.12,Ver.2.0 Version ：OLV-2-20210412

Structural Features........................................................................................................5 5. Technical Indicators.......................................................................................................5 6. 7. 8. 9. Product Installation.......................................................................................................7 Product Use.....................................................................................................................8 Maintenance...................................................................................................................14 Troubleshooting............................................................................................................ 15 10. Transportation and Storage.......................................................................................17 11. After-Sale Services........................................................................................................18 12. Accessories..................................................................................................................18 13. Packing List................................................................................................................19 14. AnnexedTable and Figure.........................................................................................20 15. Important information regarding Electro Magnetic Compatibility (EMC).........21

Our series medical oxygen concentrator adopts AC 220V/AC110V power supply, uses air as raw material and high-quality molecular sieve as adsorbent, and adopts the principle of pressure swing adsorption (PSA) to directly separate oxygen from nitrogen at normal temperature, oxygen of high purity is thereby produced. In order to ensure the safety and effectiveness of medical oxygen concentrator, please read this manual carefully before using the machine, so as to have a comprehensive understanding and knowledge of the product performance as well as correct operation and maintenance methods. Please strictly observe relevant safety precautions during installation, use and maintenance. 1.1 Functions of oxygen By supplying oxygen to patients, the machine can help the treatment of cardiovascular and cerebrovascular diseases, respiratory diseases, chronic obstructive pneumonia etc. and the rehabilitation of anoxic patients. Oxygen absorption can improve physical oxygen supply condition and achieve the purpose of oxygenating care. It is suitable for the middle-aged and elderly, people with poor physical fitness, pregnant women, students and other people who suffer different degrees of physiological hypoxia. It can also eliminate fatigue and restore somatic function after heavy physical or mental exertion. 1.2 Scope of application It is applicable for oxygen generation in medical institutions and family etc. for the use of anoxic patients. 1.3 Product features 1) Plastic casing, novel design, simple operation, stable operation, easy maintenance. 2) Generate oxygen adopting physical methods, with air as raw material, without the use of additives, only needing power supply, with low cost. 3) Adopt pressure swing adsorption (PSA) technology of efficient molecular sieve, with simple process flow and low energy consumption. 1.4 Specification & model OLV-5 Atomization function (Optional function) Product code, maximum recommended flow W -1-

2.1 Safety precautions Safety Precautions Warning 1. This product can not be used for life support or life sustaining. Patients who can not express discomfort or can not hear or see alarm signals require additional care. 2. Oxygen therapy may be harmful under certain conditions. Patients shall correctly control oxygen flow and oxygen absorption time under the guidance of physician. 3. Excessive use of high-purity oxygen has toxic and side effect on human body. 4. People suffering severe carbon monoxide poisoning shall not use this product. 5. To prevent power failure or possible failure of oxygen concentrator, when the patients�in urgent need of oxygen and the critically ill patients absorb oxygen using this product,other standby oxygen supply devices (e.g.: oxygen cylinder, oxygen bag, etc.) must be�provided. 6. If the medical oxygen concentrator can not work properly, or if you feel uncomfortable, please stop using immediately and consult physician or supplier to solve the problems. 7. Oxygen is a kind of combustion supporting gas, thus the oxygen concentrator can not�be used in places with open flame or the danger of flammability, smoking or open flame is�prohibited near people who absorb oxygen. 8. Power supply must comply with electrical safety regulations. 9. Please turn off the power and unplug the power cord before the cleaning and maintenance of medical oxygen concentrator. 10. People without authorization of the company shall not open the cover for maintenance. 11.When the altitude, ambient temperature, and relative humidity of the use environment exceed the requirements of the use environment specified in this manual, it�may cause a decrease in oxygen concentration and shutdown, which will affect the quality�of the user's treatment. ��������12.Oxygen makes fires more likely to occur and spread. If the oxygen�concentrator ����is turned on but not in use, do not leave the nasal cannula or mask on�the bed sheet or ����chair cushion; oxygen will make the material flammable. When not�in use, turn off the ����oxygen concentrator to prevent local ambient oxygen�concentration from increasing. 13. The product is suggest to use in areas with stable power grid. For continuously ����using this product under unstable power grid, an UPS is recommended. -2-

Electromagnetic Environment Guidance 1. This product is suitable for use in places including hospitals, family and other buildings connected with power supply of civilian low-voltage network. 2. Radio frequency energy used by this product is for internal operation only. Therefore, its radio frequency emission is very low, without impact on other electrical equipment nearby. 3. Due to the impact of radio transmitting devices or other sources of electrical noise in health care establishments, serious interference caused by too close distance or large transmitting power may cause interruption of this product. 4. If this happens, check the use places to find out the source of interference, and take the following measures to eliminate interference: 1) Turn off nearby devices before starting the machine; 2) Change the direction or location of interfering devices; 3) Increase the distance between interfering devices and this product. 2.3 Environmental protection description Environmental ProtectionDescription Attention Disposal ofwaste and residues shall comply with the legal provisions of corresponding countries. -3-

concentrator is shown in Fig. 1: Fig. 1 Flow chart ofmedical oxygen generation Our series medical oxygen concentrator uses molecular sieve as adsorbent, adopts the principle of pressure swing adsorption (PSA), sends the air after filtration into the molecular sieve adsorption tower for the cyclic process ofpressurized adsorption and decompressed desorption, oxygen ofhigh purity is thereby produced. -4-

Our medical oxygen concentrator mainly consists of principal machine, flow meter and humidifier bottle, as shown Fig. 2. Fig. 2 Outline drawing of Olive series medical oxygen concentrator 5. Technical Indicators The requirement of this medical oxygen concentrator for electric shock protection measures is ClassⅡ , the requirement for electric shock protection degree is type B. 5.1 Operating environment (oxygen concentration status indicator) Ambient temperature: 10℃ ~ 40 ℃ Relative humidity: 30% ~ 75% Atmospheric pressure: 860hPa ~ 1060hPa Power supply:AC 220V±22V 50Hz ±1Hz ； AC 110V±11V 60Hz ±1Hz There shall be no corrosive gas or strong magnetic field in surrounding environment 5.2 Air requirements Impurities in raw material air: ≤0.3 mg / cm3 Oil content in air: ≤ 0.01ppm 5.3 Product functions Timing function: show the total working time through display screen Time setting: set oxygen absorption time as required -5-

time Power failure alarm function Low voltage alarm function Low oxygen concentration alarm functio Circulating pressure failure alarm function Air compressor short circuit alarm function Atomization treatment function (only models with atomization function) 5.4 Technical indicators 1) Physical and chemical indicators of oxygen: Oxygen concentration: ≥ 90% (V/V) Water content: ≤0.07g/ m3 Carbon dioxide content: ≤ 0.01% (V/V) Carbon monoxide content: meet the requirements of table 1 in GB 8982－2009 Gaseous acid and alkali content: meet the requirements of table 1 in GB 8982－ 2009 Content of�ozone and other gaseous oxides: meet the requirements of table 1 in GB 8982－2009 Odor: odorless Particle size of solids: ≤ 10μm Content of solids: ≤0.5 mg/m3 2) Technical indicators ofproduct: The maximum recommended flow (when oxygen concentration ≥ 90%): 3L/min (models OLV-3 and OLV-3W); 5L/min (models OLV-5 and OLV-5W) Flow range when outlet nominal pressure is 7 kPa (oxygen concentration ≥ 90%): 0～3L/min (models OLV-3 and OLV-3W); 0～5 L/min (models OLV-5 and OLV-5W) At the recommended maximum flow, flow change when the back pressure of7 kPa is applied: <0.5L/min Flow range when outlet nominal pressure is 0 (oxygen concentration ≥ 90%): 0～3L/min (models OLV-3 and OLV-3W); 0～5 L/min (models OLV-5 and OLV-5W) Operating noise of the machine: ≤40dB (A) Timer error: not more than 3% Output pressure: 20kPa ~ 60kPa Release pressure of air compressor safety valve: 200kPa ~ 300 kPa Oxygen concentration measurement: 0～95%, error≤±3% Operating mode: continuous operation Atomization quantity: ≥0. 15mL/min (only models with atomization function) Inputpower: 330VA±15% (models OLV-3 and OLV-3W); 500VA±15% (models OLV-5 and OLV-5W) Power supply: 220V-230V 50HZ/60HZ Total weight: 19kg (models OLV-3 and OLV-3W); 22kg (models OLV-5 and OLV-5W) External dimensions: 490×270×560 (mm) L × W × H -6-

6.1 Unpacking inspection Open the carton box from top of the packing box, and then open the plastic bag, pull up the medical oxygen concentrator by grasping the front and back handles of medical oxygen concentrator. Carefully check whether there is any transport damage to the medical oxygen concentrator, and then check the accessories and relevant documents according to the packing list. 6.2 Installation precautions Installation Precautions Attention 1. Medical oxygen concentrator shall be installed in indoor ventilating places without dust, corrosive, toxic or harmful gases or smoke. Avoid direct sunlight, and the distance from walls and other objects shall be greater than 10cm. 2. Medical oxygen concentrator shall not be installed in places with open flame, fire source, danger of flammability or explosion, humidity, too high or too low temperature. Besides, it shall not be used in a closed room (space). 3. No sundries, water or oil containers shall be placed on top of medical oxygen concentrator. 4. Medical oxygen concentrator shall not be placed on soft surfaces (e.g. bed, couch) that may cause tilting or sinking, avoid shutdown or oxygen concentration decrease caused by too high temperature due to blockage of air inlet or outlet. 5. Medical oxygen concentrator shall be placed smoothly, otherwise it will increase the noise during operation. 6. If grid voltage is instable and exceeds the range of 220 ± 22V, please install voltage stabilizer before use. 7. Be sure to install battery before use, otherwise it will lose some alarm functions. 8. Please use safe and qualified socket and the wiring board with safe electricity certification. -7-

7.1 Use precautions Use Precautions Attention 1. During use, ensure unobstructed exhaust at the bottom of medical oxygen concentrator, otherwise it may cause internal overheating. 2. When the output oxygen is less than the maximum recommended flow, oxygen concentration reaches 90%. When the flow exceeds the maximum recommended flow, oxygen concentration will reduce with the increase of flow. 3. Medical oxygen concentrator will reach the specified performance after started for 10 minutes. 4. There will be intermittent exhaust sound (every 6 seconds around) during operation of medical oxygen concentrator, which is normal. 5. No oil, grease or other similar substances shall be used on or near medical oxygen concentrator, and no lubricant other than those recommended by the manufacturer shall be used. 6. During use, timely add water when water level of humidifier bottle is below the minimum level.suggest use our company humidifier bottle . 7. During atomization treatment, please do not use medical oxygen concentrator for oxygen absorption. 8. Medical oxygen concentrator shall not be started frequently, it shall be restarted after stopped for 5 minutes. 9. When the indicated oxygen concentration is abnormal, stop using, and contact the dealer or manufacturer for inspection and maintenance. 10. Molecular sieve will become aging due to use time and environment etc., causing unrecoverable decrease of oxygen generation amount. In case of this phenomenon, please contact the dealer or manufacturer to replace the molecular sieve. 11. For long-term stopping of medical oxygen concentrator, be sure to unplug the power cord. 12.Oxygen tube and nebulizer kits are one-time use parts, users buy according to their needs. -8-

1)Add water to humidifier bottle: Pull out the silicone rubber tube from the bottle, take out the bottle. Add proper amount ofpure water to the bottle, the water level shall be between the maximum (MAX) and minimum(MIN) water lines, and then tighten the bottle cap, put into the transparent cover and insert the silicone rubber tube. 2) Power on: plug in the power cord, press the "Power switch", the "Power" indicator will be on. Medical oxygen concentrator enters into the ready-to-start state, which means that the medical oxygen concentrator enters into the ready-to- start state 3) Continuous/timed oxygen generation: Press the "Oxygen generation/timing button", oxygen concentrator will be started and enters into "Continuous" oxygen generation working state. The LCD displays the total use time and other contents of -9-

started, press the "Oxygen generation/timing button" again, medical oxygen concentrator will enter into timed oxygen generation state, and the timing is 30 minutes (see Fig. 6), for each press of "Oxygen generation/timing button", preset time will be increased by 30 minutes (maximum preset time is 120 minutes); users can preset the time for oxygen generation as required. After a timing of 120 minutes, press the "Oxygen generation/timing button" again, oxygen concentrator without atomization function will stop oxygen generation, while oxygen concentrator with atomization function will enter into atomization mode, press the "Oxygen generation/timing button" again, it will stop oxygen generation. Total time: 00000H Oxygen is being generated 30 minutes Fig. 6 Display oftimed oxygen generation 4) Adjust flow: Open the transparent cover, slowly rotate the flow control knob to the desired flow rate (the reading shall be subject to the center of the black float) in the direction marked on the "Flow control knob". Meanwhile, there are bubbles in water in humidifier bottle, there shall be oxygen output from "Oxygen outlet". 5) Start oxygen absorption: Insert oxygen tube in the "Oxygen outlet" of humidifier bottle, close the transparent cover, after confirming that there is oxygen output from oxygen tube nose, wear the oxygen tube (see oxygen tube operating instructions for wearing methods ofoxygen tube) to start oxygen absorption. 6) Automatic shutdown: After reaching the preset oxygen generation time, oxygen concentrator will automatically shut down. The display ofLCD is shown in Fig. 7. Total time: 00038H Shutdown Time out Fig. 7 Shutdown display 7) Shut down immediately: During operation of medical oxygen concentrator, press the "Power switch" on top cover, medical oxygen concentrator will shut down immediately. 8) Atomization function: (atomization models only) ① Before using the atomizer, please refer to Operating Instruction ManualforAtomizer. ②Open the transparent cover of oxygen concentrator, unscrew the plug from the atomization mouth, insert the air inlet pipe ofthe atomizer in the atomization mouth. -10-

Fault indicator Red Table 1 Alarm functions Alarm item Cause Alarm sound Color ofindicators Display ofLCD Power failure alarm Power supply voltage interruption Yes N/A Low voltage alarm Power supply voltage is less than 180V±10V Yes Fault indicator Red Low voltage Oxygen concentration alarm 65%(±3%)≤Oxygen concentration＜82%(±3%) Yes N/A Failure Oxygen concentration≤65%(±3%) Yes Low concentration High pressure alarm Circulating systempressure is high Yes Low pressure alarm Circulating systempressure is low Yes Low pressure Air compressor failure alarm Short circuit ofcompressor Yes Shutdown Air compressor failure After medical oxygen concentrator is started, press the "Oxygen generation/timing button" for 5 times, oxygen concentrator with atomization function will enter into atomization mode. ④After atomization is finished, pull out the air inlet pipe ofatomizer, tighten the atomization plug. ⑤ For long-term stopping ofmedical oxygen concentrator, be sure to unplug the power cord. 7.3 Alarm functions After medical oxygen concentrator is started and generates oxygen for 10 minutes, during normal operation, "Power", "Oxygen concentration" and "Fault" indicators are green. In case of faults listed in Table 1, medical oxygen concentrator will send audible/visual alarm. Alarm functions are shown in Table 1. -11- Oxygen concentration indicator Yellow Oxygen concentration indicator Red Fault indicator Red Fault indicator Red

When grid voltage is suddenly interrupted (power failure), medical oxygen concentrator will stop working and send alarm sound, fault indicator will be red, please use after power on. 2) Low voltage alarm When grid voltage is less than 150V ± 10V, medical oxygen concentrator will stop working and send alarm sound; fault indicator will be red; LCD displays "Low voltage", it is recommended to install voltage stabilizer. 3) Oxygen concentration alarm After medical oxygen concentrator is started and generates oxygen for 10 minutes, under the circumstance that the output oxygen flow is not greater than the maximum recommended flow: When oxygen concentration is 82%( ± 3%) or more, the oxygen concentration indicator is green. Medical oxygen concentrator works properly. When oxygen concentration is within 65%(±3%)～82%(±3%), the oxygen concentration indicator is yellow and sends alarm sound, contact the dealer immediately, users can temporarily use the machine, and please ensure that there is standby oxygen. When oxygen concentration is below 65%(±3%), the oxygen concentration indicator is red and sends alarm sound, LCD displays "Low concentration". Please shut down immediately. Use standby oxygen and contact the dealer for inspection or repair. 4) High/low pressure alarm When circulating system pressure is high, medical oxygen concentrator shuts down and sends alarm sound; fault indicator is red, the LCD displays "High pressure". When circulating system pressure is low, medical oxygen concentrator sends alarm sound; fault indicator is red, the LCD displays "Low pressure". In case of high pressure or low pressure alarm, please use standby oxygen and contact the dealer for inspection or repair. 5) Air compressor failure alarm In case of short circuit of air compressor circuit, medical oxygen concentrator shuts down and sends alarm sound; fault indicator is red; the LCD displays "Air compressor failure", medical oxygen concentrator stops running. Please use standby oxygen and contact the dealer for inspection or repair.

When it is necessary to check whether the alarm system works, unplug the power cord when medical oxygen concentrator works normally, if the fault indicator becomes red and sends alarm sound, then the alarm system is normal, otherwise the alarm system can not work normally, contact the dealer for inspection or repair. 7.4 How the operator check machine is normal : The operator can check whether the oxygen concentrator is operating normally by the following methods: 1) 10 minutes after the oxygen concentrator is turned on, the power indicator, oxygen concentration indicator, and fault indicator should be green. 2) In the state of oxygen generation, block the oxygen outlet of the oxygen concentrator by hand, and the flowmeter should be able to return to the "0" position. If the above two points are met, it means that the oxygen concentrator is operating normally. Otherwise, the oxygen concentrator is not operating normally, you should contact the dealer for inspection or repair

Maintenance Considerations Attention 1. Only the dealers authorized by the manufacturer or the qualified personnel after special training can conduct preventive maintenance or performance adjustment for medical oxygen concentrator. 2. In case of medical oxygen concentrator failure, contact the dealer or manufacturer for repair. Do not disassemble for repair by yourself. 3. Clean the humidifier bottle every day. Add pure water to humidifier bottle and the water level shall be between the maximum and minimum water levels. 4. Regularly clean air suction filtering foam and filtering cotton according to requirements. Clean in advance in case oftoo much dust. oxygen concentrator shall not be started before filtering cotton and foam are installed. 5. Power cord is provided according to the power ofoxygen concentrator, please do not replace arbitrarily. 8.2 Cleaning of humidifier bottle -14- To clean, first pull out the silicone rubber tube from humidifier bottle, take out the humidifier bottle. Humidifier bottle is generally cleaned with clean water, in case of any water scale, rinse with clean water after descaling. During cleaning, pay attention to cleaning the small air inlet hole at the bottom of the core tube in the bottle, so as to keep oxygen unobstructed. After cleaning, sterilize (soak in disinfectant containing available chlorine of 500mg/L) and rinse with pure water. Add proper amount of pure water to the bottle, the water level shall be between the maximum (MAX) and minimum (MIN) water lines, and then tighten the bottle cap, put into the transparent cover and insert the silicone rubber tube. 8.3 Cleaning of atomizer (atomization models only) After using the atomizer, pour out all residual liquid from atomizing cup, rinse with clean water. After cleaning, sterilize (soak in disinfectant containing available chlorine of 500mg/L) and rinse with pure water. 8.4 Cleaning of primary air suction filter (filtering sponge) and secondary filter Timely cleaning and replacement of primary air suction filter and secondary filter are very important for protecting air compressor and molecular sieve, and extending the service life of medical oxygen concentrator, please timely clean and replace according to requirements. Primary air suction filter shall be cleaned once a week. During cleaning, draw out filtering sponge and rinse with clean water, it can be used after natural drying.

cleaning, unscrew the filter clockwise, take out the filter and rinse with clean water, after natural drying, install it to the original place and tighten counterclockwise. 8.5 Cleaning of medical oxygen concentrator When turning off the power of medical oxygen concentrator, use a soft towel dipped with a small amount of neutral household cleaner to wipe the casing, and then use a dry towel to dry up. When wiping, pay attention to preventing liquid infiltrating into casing slot. 8.6 Replacement of battery When the power failure alarm sound of medical oxygen generated is reduced significantly (users can check it by disconnecting the power supply of medical oxygen concentrator), it is necessary to replace the battery. Battery specifications: 9V alkali battery. To replace, open the battery compartment cover in the transparent cover, remove the old battery, insert new battery according to the marked polarity. 9. Troubleshooting In case of any problems during use, before sending the machine for repair, please read this section carefully, you may simply solve the problems by yourself. If the problems can not be solved according to the examples in Table 2, please send the medical oxygen concentrator for repair. Do not attempt to repair or remove the casing of medical oxygen concentrator by yourself. -15-

Fault symptom Check item Measures There is no display on LCD when starting or running, medical oxygen concentrator sends alarm sound. 1. Power failure? 2. Power cord is loose? 1. Use the machine after power on. 2. Check and insert the power cord properly. Concentration indicator becomes yellow or red. 1. Oxygen flow is too large? 2. Molecular sieve becomes aging after long -term use? 1. Adjust the oxygen flow. 2. Replace molecular sieve. Note: Replacement ofmolecular sieve shall be conducted by professionals. Medical oxygen concentrator works normally, but no oxygen is outputted from oxygen tube. 1. Whether the oxygen tube is inserted properly? 2. Whether the humidifier bottle cap is tightened? 1. Insert the oxygen tube properly. 2. Tighten the humidifier bottle cap. Medical oxygen concentrator works normally, but the flow can not be adjusted to the maximum value, bubbles in humidifier bottle are small. 1. Air suction filter is clogged with dust? 2. Oxygen tube is bent? Operating noise is large. 1. Clean or replace filter. 2. Unbend the oxygen tube. Whether medical oxygen concentrator is placed smoothly? Place the medical oxygen concentrator smoothly. Alarm fault indicator is red. Low voltage It is recommended to install voltage stabilizer. Alarm fault indicator is red. Circulating pressure is low. 1. Clean or replace filter.2. If such situation continues, please contact the manufacturer. Immediately stop using the machine, please Alarm fault indicator is red. Circulating pressure is high. contact the manufacturer. -16-

red. Air compressor failure Immediately stop using the machine, please contact the manufacturer. There is no alarm sound during power off, alarm indicator is not on. Other faults Are the batteries dead? Replace battery. Contact the manufacturer 10. Transportation and Storage 10.1 Transportation and storage precautions Transportation and Storage Precautions Attention 1. Before transportation or storage, pour out the water from humidifier bottle. 2. During transportation and handling, medical oxygen concentrator shall be kept upright, prohibit inversion or horizontal placing. 3. When the storage temperature is below 10 ℃, place the medical oxygen concentrator in normal working environment for 8 hours before use. 4. Medical oxygen concentrator that has been stopped for long time shall be powered on for inspection before use again, and confirm that all functions are normal before use again. 10.2 Requirements for storage and transportation environment -17- Ambient temperature -20 ℃ ~ 50 ℃; Atmospheric pressure 500hPa～1060hPa Relative humidity ≤ 95%; 10.3 Transportation Medical oxygen concentrator packed completely shall be protected from violent collision and direct contact with rain or snow during transportation. 10.4 Storage Medical oxygen concentrator shall be stored in indoor well-ventilated places without strong sunlight and corrosive gases.

avoid adverse effects on safety and product performance. 2. Medical oxygen concentrator shall use dedicated humidifier bottle, for replacement, please contact the dealer or manufacturer to purchase. 3. The presented oxygen tube is a disposable sterilization product, just for one person. Users can purchase qualified products with Medical Device Registration Certificate by referring to the model and specification of the presented sample. 11. After-Sale Services 11.1 Warranty period In case of quality problems caused by non-human factors within one week since the date of sale, our company will be responsible for guaranteed repairing, changing and refunding; under normal use and storage conditions, the warranty period of this product is two years or 5,000 hours (whichever is earlier), the warranty period of compressor is three years. In case of any quality problems within warranty period, our company will repair for free; In case of any quality problems after the warranty period, our company will charge repair cost. If the users can not provide invoices, the warranty period shall be regarded as one month since the ex-factory date of the company. 11.2 Warranty scope： The following circumstances shall not be within the free warranty of the company: 1) Damage due to improper operation of users or use under abnormal conditions; 2) Damage or deformation of machine (including components and parts) due to collision or falling; 3) Damage due to disassembly, repair or modification by users; 4) Damage caused by natural disasters; 5) Wearing parts and consumables: atomizer, filtering foam, filtering cotton etc.; 11.3 Notice : 1) oxygen concentrator can only be repaired by the company authorized by the company,and user cannot be disassembled privately 2) No modification to the oxygen concentrator. 12. Accessories -18-

Table 3 Packing list ofmedical oxygen concentrator No. Name Specification & Model Unit Qty Remarks 1 Principle machine Of medical oxygen concentrator OLV-3 □ OLV-3W □ OLV-5 □ OLV-5W □ Set 1 2 Power cord 0.75m ㎡×3 pc pc 1 2 3 Nasal cannula 4 Nebulizer Mouth-contained Set 1 Only atomization models 5 Spare connecting tube of humidifier cup pc 1 6 Spare first air suction filter Spare secondary air suction filter User manual pc 1 7 pc 3 8 pc pc 1 1 9 Warranty card -19-

14.1 Meaning description of graphics, symbols and abbreviations Table 4 Meaning description ofgraphics, symbols and abbreviations 14.2 Electric control chart Fig. 7 Electric control chart Note: if circuit diagram and necessary information are needed due to repair, please contact the manufacturer. 14.3 Oxygen concentration and flow diagram Fig. 8 Functional diagram ofoxygen concentration and flow when the outlet nominal pressure is 0 -20-

15. Important information regarding Electro Magnetic Compatibility (EMC) This electrical medical equipment needs special precautions regarding EMC and put into service according to the EMC information provided in the user manual; The equipment conforms to this IEC 60601-1-2:2014 standard for both immunity and emissions. Nevertheless, special precautions need to be observed: The equipment with following ESSENTIAL PERFORMANCE is intended Home healthcare environment Essential Performance: used in 1. The solenoid valve and each indicator light should work normally five minutes after the medical oxygen concentrator is turned on. Oxygen should be output, and alarm function should be available in case of failure. a) When the output oxygen concentration is lower than 82% (volume fraction), there should be an audible and visual alarm. b) When the compressor, solenoid valve or pipeline breaks down in the system, it shall make an audible and visual alarm. c) When the network power is interrupted and the equipment cannot work normally, it shall make a red-light alarm. 2. Temperature rise of medical oxygen concentrator: Under normal working conditions, the maximum temperature of the plastic housing is ≤48 ℃ , and the gas temperature at the oxygen outlet of the oxygen concentrator is ≤ 41℃. WARNING: 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”. 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 ofthis equipment and result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the product, including cables specified by the manufacturer. Otherwise, degradation ofthe performance ofthis equipment could result.” TV broadcast antennas, before using this equipment, it should be observed to verify that it is operating normally to assure that the equipment remains safe with regard to electromagnetic disturbances throughout the expected service life. -21-

Professional healthcare facility and Home healthcare environment EMI Compliance Table (Table 1) Table 1 - Emission Phenomenon Compliance Electromagnetic environment Professional healthcare facility RF emissions CISPR 11 Group 1, Class B and Home healthcare environment Harmonic distortion IEC 61000-3-2 Class A Professional healthcare facility and Home healthcare environment Voltage fluctuations and flicker IEC 61000-3-3 Compliance Professional healthcare facility and Home healthcare environment EMS Compliance Table (Table 2-4) Table 2 - Enclosure Port Phenomenon Basic EMC standard Electrostatic Discharge IEC 61000-4-2 ±8 kV contact ±2kV, ±4kV, ±8kV, ±15kV air Radiated RF EM field IEC 61000-4-3 10V/m 80MHz-2.7GHz 80%AM at 1kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 Refer to table 3 Rated power frequency magnetic fields IEC 61000-4-8 30A/m 50Hz or 60Hz -22-

Home healthcare environment Electrical fast transients/burst IEC 61000-4-4 ±2 kV 100kHz repetition frequency Surges Line-to-line IEC 61000-4-5 ±0.5 kV, ±1 kV 3V, 0.15MHz-80MHz 6V in ISM bands and amateur radio bands between 0.15 MHz and 80MHz Conducted disturbances induced by RF fields IEC 61000-4-6 80%AM at 1kHz Voltage dips IEC 61000-4-11 0% UT; 0.5 cycle At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0º Voltage interruptions IEC 61000-4-11 Table 4 – Input a.c. power Port Table 3 – Proximity fields from RF wireless communications equipment Band (MHz) Immunity test levels Professional healthcare facility and Home healthcare environment Pulse modulation 18Hz, 27V/m 385 450 710 745 780 810 870 930 1720 380-390 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1700-1990 2400-2570 1845 1970 2450 5240 5500 5785 Pulse modulation 217Hz, 28V/m 5100-5800 Pulse modulation 217Hz, 9V/m Pulse modulation 18Hz, 28V/m 0% UT; 250/300 cycles Immunity test levels -23-

11th Floor , Block B, Building 18 Henan International University Science Park ( East District), 450001 Zhengzhou, Henan PEOPLE’ S REPUBLIC OF CHINA Tel: 86 371 86097307 Eu. Rep.: MedPath GmbH Mies-van-der-Rohe-Strasse 8, 80807 München, GERMANY