User Manual for Kingon models including: P2 Portable Oxygen Concentrator, P2, Portable Oxygen Concentrator, Oxygen Concentrator
Mindray BeneHeart D30 Defibrillator and Monitor – Zone Medical
Zone Medical
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DocumentDocumentKingon User Manual P2 Portable Oxygen Concentrator Contents I. Use Intention, Contraindications and General Precautions 5 Intended Use 5 Contraindications 6 General Precautions 6 General Precautions - Continued 7 General Precautions - Continued 8 II. Description of the Kingon P2 Oxygen Concentrator 9 Parts Diagram 9 User Interface Buttons and Display Symbols 10 User Interface Buttons and Display Symbols 11 Alerts 14 Alerts 15 Accessories 17 III. Operating Instructions 18 General Operation 18 IV. Troubleshooting 22 V. Maintenance and Cleaning of Kingon P2 23 Cleaning the Case 23 Cannula Replacement 23 Filter Cleaning and Replacement 23 Battery Care and Maintenance 24 Disposal of Equipment and Accessories 25 Maintenance Item List 25 VI. System Specifications 26 Concentrator Specification 26 Concentrator Specification - Continued 27 Classifications 27 Standards Compliance 28 EMC Information 29 EMC Information - Continued 30 VII. Warranty 31 2 Symbol WARNING CAUTION Meaning A warning indicates that the personal safety of the patient may be involved. Disregarding a warning could result in significant injury. A caution indicates that a precaution or service procedure must be followed. Disregarding a caution could lead to minor injury or damage to the equipment. See user manual for instructions AC power DC power U.S. Federal Regulation Restricts this device to sale by order of physician. May also be applicable in other countries. No smoking Keep away from open flames Keep dry Do not use oil or grease Do not disassemble (contact your equipment provider for servicing by authorized personnel) Do not dispose of in unsorted municipal waste Type BF applied part Complies with applicable EU directives; included medical device directive Class II (double insulated) See instructions for use Manufacturer Authorised representative in the European community Protection against direct sprays of water up to 15° of vertical Date of manufacture Serial number 3 Symbol Meaning This side up Fragile Storage humidity (non-condensing) Storage temperature Magnetic resonance unsafe The manufacturer of this POC has determined this device conforms to all applicable FAA requirements for POC carriage and use on board aircraft 4 Intended Use, Contraindications and General Precautions I. Use Intention, Contraindications and General Precautions Intended Use The Kingon P2 Portable Oxygen Concentrator is prescribed for patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Kingon P2 is a small and portable device that may be used at the home and can be taken with you while performing your daily activities. WARNING This device is not intended to be life-sustaining or life-supporting. This device is not intended for newborn and infant use. WARNING A backup oxygen source is recommended for power outages or mechanical problems. Be sure to have an available backup oxygen source that is recommended by your doctor or healthcare provider. CAUTION In most countries, this device must be purchased from a doctor or with a doctor's prescription. CAUTION! MUST HAVE BACK UP OXYGEN SUPPLY WHEN TRAVELING. It is the responsibility of the patient to make back-up arrangements for alternative oxygen supply when traveling. We assume no liability for persons that do not adhere to manufacturer recommendations. Service Item Kingon P2 Molecular Sieve Beds Batteries Expected Life 5 Years 1 Year 500 full charge/discharge cycles CAUTION The expected life is dependent on the use environment and regular maintenance. Poor conditions will shorten the lifetime of the concentrator. WARNING The operator should read and understand this entire manual before using the device. 5 Intended Use, Contraindications and General Precautions Contraindications CAUTION This device is not intended to be life sustaining or life supporting. CAUTION Patients who are unable to hear or see an alert from the device, or who are unable to communicate discomfort while wearing the device, will require additional monitoring to avoid injury or harm. If the patient experiences any new symptoms seek medical attention immediately. CAUTION In certain circumstances, oxygen therapy can be hazardous. Please seek medical advice before using this device. CAUTION The Kingon P2 is not designed or specified to be used in conjunction with a humidifier, nebulizer or connected with any other equipment. Do not modify the Kingon P2 Portable Oxygen Concentrator. Any modifications performed on the equipment may impair performance or damage equipment and will void your warranty. General Precautions WARNING Oxygen supports combustion. To avoid risk of fire, oxygen therapy should never be used while smoking, while in the same room as someone who is smoking or in the presence of an open flame. WARNING Do not submerge the Kingon P2 or any of the accessories in liquid. Do not expose to water or precipitation. Do not operate in exposed rain. Exposure to moisture can lead to electrical shock and/or damage. CAUTION Do not use oil or grease on the concentrator or its components as these substances, when combined with oxygen, can greatly increase the potential for a fire hazard and personal injury. CAUTION Never leave the Kingon P2 in high temperatures/high humidity such as in a car in high heat or a bathroom with high humidity. This can damage the device. WARNING Geriatric patients or any other patients unable to communicate discomfort, hear or see alarms while using this device, may require additional monitoring WARNING If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm. 6 Intended Use, Contraindications and General Precautions General Precautions - Continued WARNING The oxygen delivery settings of the oxygen concentrator should be periodically reassessed to ensure effectiveness of the oxygen therapy. WARNING Set the device at the prescribed level and do not increase or decrease your flow rate from the prescribed level without first consulting with your physician or healthcare professional. WARNING Only use this device as prescribed. The use of oxygen therapy can be hazardous in some circumstances. Always consult your healthcare practitioner before using the POC. WARNING To ensure that you receive the correct therapeutic amount of oxygen delivery according to your medical condition, the Kingon P2 must be used: · Only after one or more settings have been individually determined or prescribed for you at your specific activity levels. · Only use the parts and accessories that are provided by oxygen concentrator manufacturer. WARNING The settings of the Kingon P2 might not correspond with continuous flow oxygen. WARNING The settings of other models or brands of oxygen therapy equipment do not correspond with the settings of the Kingon P2. WARNING There is a risk of fire associated with oxygen equipment and therapy. Do not use the POC near sparks or open flames. WARNING Use only water-based lotions or solutions that are oxygen compatible during setup or using during oxygen therapy. To avoid the risk of fire and burns, never use petroleum or oil-based lotions or solutions. WARNING Smoking during oxygen therapy is dangerous and may result in fire which can cause serious injury or death of the patient and others. WARNING To ensure you are receiving the required therapeutic amount of oxygen delivery according to your medical condition, the Kingon P2: · Must be used only after one or more settings have been individually determined or prescribed for you at your specific activity levels. · Must only use the parts and accessories that were provided by the manufacturer and those that were used while your personalised settings were configured. 7 Intended Use, Contraindications and General Precautions General Precautions - Continued WARNING Do not lubricate replaceable fittings, connections, tubing, or other accessories of the oxygen concentrator to avoid the risk of fire and burns WARNING Use only spare parts recommended by the manufacturer to ensure proper function and to avoid the risk of fire and burns. WARNING Wind or strong drafts can adversely affect accurate delivery of oxygen therapy. · EXAMPLE 1: Using this equipment beside an open window or in front of a fan. · EXAMPLE 2: Using this equipment in the back seat of an open convertible car. WARNING If you notice any of the following, STOP using immediately and contact your equipment provider: · Unexplained changes in the performance of this device · Unusual or harsh sounds · Dropping or mishandling the device or the power supply · Water spilled into the enclosure · Broken or cracked enclosure WARNING Oxygen is a combustion supporting gas, a fire may start easily and spread quickly. Do not leave the nasal cannula on bed coverings or chair cushions if the oxygen concentrator is turned on, but not in use. Always turn the oxygen concentrator off when not in use. WARNING To ensure proper function and to avoid the risk of fire and burns: · Use only with Kingon P2 AC and DC power supply · Use only with Kingon P2 batteries · Use only approved Kingon P2 accessories WARNING Remove the battery from the device if Kingon P2 will not be used for an extended period of time WARNING Device operation exceeding the voltage, breath rate, temperature, humidity and/or altitude values specified may decrease oxygen concentration levels. WARNING Do not modify this system or equipment in any way. Modifications could result in hazards to the user. WARNING Change in altitude may affect the actual oxygen supplied by the device. Consult your physician before traveling to a place with altitude changes. Note: additional warnings, cautions, and notes are located throughout the manual. 8 Description of the Kingon P2 Oxygen Concentrator II. Description of the Kingon P2 Oxygen Concentrator Parts Diagram 9 Description of the Kingon P2 Oxygen Concentrator User Interface Buttons and Display Symbols Display Panel Symbol Item ON / OFF Button Description Press once to turn ON. Press and hold for one second to turn OFF. Press once to toggle between audible and silent mode. The screen will display the appropriate icon to indicate which mode is enabled: Audio Alarm Button Audible mode: Silent mode: When audible mode is enabled, a yellow light will turn on, and a message will be displayed on the screen. Press this button to mute or unmute alarms. Increase or decrease the oxygen flow by pressing the Flow Setting Control Buttons - or + button. Flow settings range from 1 to 5. Press to display information about the device. Device Information The information includes: battery temperature, battery sta- tus, molecular sieve temperature, molecular sieve runtime, device model, device temperature, device runtime, firmware version, and hardware version. 10 Description of the Kingon P2 Oxygen Concentrator User Interface Buttons and Display Symbols Home Screen Symbol Description Current flow setting Range is from 1 to 5 Battery charge level · Battery percentage · Battery time remaining Device runtime since powered on hr : min Alerts are silenced Audible alerts are on The screen will also display the following icons (see the next page): 11 Symbol Description of the Kingon P2 Oxygen Concentrator Powered by AC or DC only. Description 1. Powered by battery only (not plugged in and not charging) 2. Battery level percentage and time remaining 3. Device is ON 1. Battery is charging 2. Battery level percentage and estimated time to fully charge the battery 3. Device is ON 1. Battery is charging 2. Battery level percentage and estimated time to fully charge the battery 3. Device is OFF The device has detected an active alarm while in silent mode. The device has detected an active alarm while in audible mode. Runtime of device since it was powered on. Example displays 2 hours 35 minutes. More than one alert has been detected. Display will scroll to display all alerts. 12 Description of the Kingon P2 Oxygen Concentrator Alerts in Audible Mode: The following shows the device has detected an active alarm while in audible mode. Example below shows "Absence of Breath". Alerts in Silent Mode: The following shows the device has detected an active alarm while in silent mode. Example below shows "Absence of Breath". 13 Description of the Kingon P2 Oxygen Concentrator Alerts Adapter plug / unplug: An adapter icon displays when adapter is plugged in and disappears when unplugged. An audible alarm (if enabled) will also sound. Battery plug / unplug: A battery icon displays when battery is connected and disappears when disconnected. An audible alarm (if enabled) will also sound. Alarm audio selection: An alert will indicate when the device is turned ON or OFF. Alarm audio pulse duration: An audible alert (if enabled) will pulse between 150ms ON, 150ms OFF, repeat 2 times. Alarm audio pulse group interval: 14.7s (until alarm returns to normal) Alarm details: Reference the table below for additional alarm details. 14 Description of the Kingon P2 Oxygen Concentrator Alerts Alarm item Alarm condition System process Display of screen Battery Exhausted Battery cycle >500 Or health <50% Alarm only Battery Exhausted Replace Sieve Bed Sieve bed expired or Sieve Alarm only bed chip error Replace Sieve Bed Contact Provider Low Input Voltage Adapter input <17.0v Auto switch to battery until Low Input Voltage the adapter input >18v Check Adapter Absence Of Breath No breath detected continuously for >15S Alarm only Absence of Breath Check Cannula Oxygen Concentration <87% Concentration 87% continuously for >300S Alarm only Low O2: <87% Contact Provider Low Battery 5% RSOC 20% Without adapter Alarm only Low Battery Charge Now Oxygen Concentration <50% concentration 50% continuously for >300S Shutdown after 30s Low O2: <50% Contact Provider Breath Sensor Fail Breath sensor failed Shutdown after 30s Breath Sensor Fail Contact Provider Oxygen Sensor Fail Oxygen sensor failed Shutdown after 30s Oxygen Sensor Fail Contact Provider Gas Delivery Fail No delivery detected after injection Shutdown after 30s Gas Delivery Fail Contact Provider Gas Obstruction Pipe or nasal blocked Shutdown after 30s Gas Obstruction Contact Provider Tank Pressure Fail Tank pressure failed Shutdown after 30s Tank Pressure Fail Check Cannula Sieve Bed Fail Sieve bed failure or invalid Shutdown after 10s Sieve Bed Fail Contact Provider Compressor Fail Compressor failed Shutdown after 10s Compressor Fail Contact Provider Valve Check Fail Valve switch failed Shutdown after 10s Valve Check Fail Contact Provider Cooling Fan Fail Cooling fan failed Shutdown after 10s Cooling Fan Fail Contact Provider Battery Depleted RSOC 5% Without adapter Shutdown after 10s Battery Depleted Replace Battery or Connect to adapter System Cold System temperature <0 Shutdown after 10s System Cold Shut down, move to warmer place Battery Cold Battery temperature <0 Shutdown after 10s Battery Cold Shut down, move to warmer place System Hot System temperature >60 Shutdown after 10s System Hot Shut down, move to cooler place Battery Hot Battery temperature >65 Shutdown after 10s Battery Hot Shut down, only Use adapter Gas Supply Fail Sys Startup Fail Flow or concentration below normal after injection Concentration < 87% continuously >15s after system startup Shutdown after 10s Shutdown after 10s Gas Supply Fail Contact Provider Sys Startup Fail Contact Provider Power Supply Fail System voltage <10.5v Shutdown after 10s Power Supply Fail Contact Provider 15 Description of the Kingon P2 Oxygen Concentrator Power Supply Standard Lithium Ion Battery # BA-P200 The Kingon P2 is powered by standard lithium-ion battery. When fully charged, the battery can provide up to 4 hours of operation. Recharge the battery with the AC or DC adapter. Charging time should not take longer than 4 hours. AC Power Supply # EM11012E The AC power supply is used to power the Kingon P2 Oxygen Concentrator from an AC power source. When used with AC power sources, the power supply automatically adapts to input voltages from 100V to 240V (50-60HZ), permitting use with most power sources throughout the world. Connect A plug to nearest AC power outlet connect C plug to D port connect B plug to Kingon P2 A B C D DC Power Supply The DC power supply is designed to power the Kingon P2 Oxygen Concentrator from a DC power supply such as a car cigarette lighter or auxiliary DC power supply. The input DC power is 11-16V DC with a built-in 15A/125V fuse for over-current protection. The charger output is 19V at 6.3A. WARNING Do not use power supplies, adapters or accessories other than those specified above. The use of non-specified accessories may create a safety hazard or impair equipment performance. 16 Description of the Kingon P2 Oxygen Concentrator Accessories Nasal Cannula The Kingon P2 must use a single lumen nasal cannula to provide oxygen to the patient. WARNING Nasal cannulas should not be used by more than one person. DO NOT use a cannula length exceeding 7.6m. CAUTION When using a long cannula, the flow setting may need to be increased. CAUTION Increasing the cannula length may reduce the perceived noise during oxygen bolus delivery. CAUTION The cannula is designed for disposable use. CAUTION Choose only the CE marked nasal cannula. Carry Bag The Kingon P2 carry bag allows you to go out for daily activities with the device. Item Nasal Cannula Carry Bag AC Power Supply DC Power Supply Battery Intake Filter Quantity 1 pc 1 pc 1 pc 1 pc 1 pc 5 pc 17 Model Number NOC-DAW0721 CB-P200 EM11012E ED1010C BA-P200 FI-P201 Operating Instructions III. Operating Instructions General Operation 1. Find a well ventilated location to place the Kingon P2. Ensure the unit is turned off. Ensure the intake and exhaust has clear access. The Kingon P2 should be operated in a place where alarms can be heard. WARNING Do not use the Kingon P2 in the presence of flammable anesthetics, detergents, or other chemical vapours. CAUTION Do not block the air intake or air exhaust when operating the equipment. Blocked air circulation or proximity to the heat source can cause internal heat build-up, shut down, or damage to the concentrator. CAUTION The Kingon P2 concentrator is designed for continuous use. It is useful to operate the device frequently for optimal sieve bed life. CAUTION The Kingon P2 is shipped from factory with battery removed. CAUTION Choose CE marked nasal cannulas (e.g. Runmai NOC-DAW0721) 2. Ensure the particle filters are in place. CAUTION Do not operate the Kingon P2 without the intake filter and pre-filter cover in place. Operation without these in place can damage the device. 18 Operating Instructions 3. Install the battery. Slide the battery into place until the latch returns to the upper position along with an audible sound. 4. Connect the AC or DC power to the Kingon P2. The green LED on the power adapter will be on and the concentrator will beep. CAUTION Do not place anything in the power supply port other than the supplied wall cord. Avoid the use of electrical extension cords with the Kingon P2. CAUTION Power supply is not waterproof. Do not disassemble the power supply. CAUTION When the power is disconnected from the AC outlet, disconnect it from the concentrator to avoid unnecessary battery discharge. 19 Operating Instructions 5. Join the nasal cannula to the nozzle fitting. Nozzle fitting is located on the top side of the Kingon P2 near the pre-filter. Connect a nasal cannula to the nozzle fitting. CAUTION Ensure that the cannula is routed to prevent it from being pinched or kinked to avoid a disruption of oxygen flow. CAUTION Disposable usage for the cannula. 6. Switch on Kingon P2 by pressing the ON/OFF Button. A beep will sound and the indicator light will flash. "Welcome" will appear on the display when the concentrator starts up. The display will indicate the selected flow setting and power condition. A two minute warm-up will initiate. During this period the oxygen concentration may not have reached the specified value. Under special conditions, a longer warm up time may be necessary, such as extremely cold temperatures where the Kingon P2 was stored or is being operated. CAUTION Oxygen concentration may not reach specification during the two-minute warm up time. CAUTION Kingon P2 will enter auto-pulse mode after 30 seconds of starting up. Allow 30 seconds after turn on before beginning to inhale. 7. Set the setting to the flow rate prescribed by your provider. Press the + or setting buttons to adjust the Kingon P2 to the desired flow rate. The current setting can be viewed on the display from 1 to 5. CAUTION Make sure the power supply is in a well-ventilated place. During operation, the power supply may get hot. Make sure the power supply is cool before handling. 20 Operating Instructions 8. Wear the nasal cannula on your face and breathe through your nose. The Kingon P2 will sense if you are breathing from it. If you are not yet breathing through the cannula, the Kingon P2 will begin to pulse automatically about every 3 seconds. As soon as you begin breathing through the cannula, the device will begin delivering pulses based on your breathing. As your breathing rate changes, the Kingon P2 will sense these changes and adjust the amount of oxygen at next inhale. WARNING If you feel uncomfortable using the device, consult your immediately. CAUTION If the oxygen level drops below <87%, an alert will notify you. If the alarm persists, contact your device provider. CAUTION The display backlight will dim if there is no operation of the device for 30 seconds. You can press any button to reactivate the display backlight. CAUTION The Kingon P2 will alert with audible and visual signals such as "Absence Of Breath". When this alert is enabled and no breath has been detected for 15 seconds, the device will enter auto pulse mode. Once breath is detected, the device will exit auto pulse mode and resume normal delivery of oxygen. General To remove power, disconnect the input cord from AC power source (like AC wall outlet) and disconnect it from the Kingon P2. 21 Troubleshooting IV. Troubleshooting The table below lists some common problems and solutions. If you can't resolve a problem, please contact your equipment provider. Problem Possible Cause Recommended Solution Battery is not installed correctly Remove the battery and re-install it correctly. Device won't turn on Battery is depleted The AC supply is not connected properly Use the AC or DC power adapter to operate the device (with battery inserted) to recharge the battery. If this does not resolve the problem, contact your equipment provider. Check AC power supply connection and verify the green light on the adapter. The DC supply is not connected properly Check DC power supply connection and at the auxiliary or cigarette lighter power source. The device is not turned on Turn on the concentrator. No oxygen Cannula is kinked or obstructed Check cannula and its connection to the oxygen outlet port. Equipment failure Contact your equipment provider. Oxygen not at full concentration The device is warming up Wait 2 minutes for the device. If the problem is not solved, please contact your equipment provider. The sieve beds may require servicing Contact your equipment provider to change the sieve beds. Alarm occurs A problem has been detected by the device Refer to previous section - Alerts. 22 Maintenance and Cleaning of Kingon P2 V. Maintenance and Cleaning of Kingon P2 Cleaning the Case The outside case should be cleaned using a cloth dampened with a solution of mild detergent and water. CAUTION Do not allow liquids into any of the controls, the interior of the case, or the oxygen tubing connector. If this occurs, contact your equipment provider for assistance. WARNING Do not use alcohol, isopropyl alcohol, ethylene chloride or petroleum based cleaners on the cases or on the particle filters. Cannula Replacement The nasal cannula is designed for disposable usage. You can buy replacements from the physician and/or equipment provider. Follow the cannula manufacturer's instructions. CAUTION Nasal cannula should be rated for 5 litres per minute to ensure proper patient usage and oxygen delivery. Filter Cleaning and Replacement Filters are designed to adequate air flow through the device at the front of the Kingon P2. Pre-Filter This particle screen must be cleaned on a weekly basis to ensure adequate air flow through the device. Clean with a mild liquid detergent and water. Ensure that the filter is completely dry before use. CAUTION It may be necessary to clean the particle filters more often in dusty or bad environments/conditions. 23 Maintenance and Cleaning of Kingon P2 Intake Filter The intake filter is designed to ensure the clean air enters the compressor. 1. Unscrew the screw on the bottom of pre-filter with a phillips screwdriver. 2. Lift the particle screen up by the bottom end then remove it. 3. Remove the cotton intake filter from the intake chamber. 4. Replace a new intake filter into the chamber. 5. Install pre-filter cover. Pre-filter and cotton intake filters can be purchased from your equipment provider. It is suggested to replace the cotton intake filters once a month. Depending on use, you may not need to replace as often if it is not dirty. Battery Care and Maintenance The Kingon P2 Lithium Ion Battery requires special care to ensure proper performance and long life. Only use Kingon P2 batteries #BA-P200 with your concentrator. CAUTION Keep liquids away from batteries. If batteries become wet, stop use immediately and dispose of battery properly. Battery Replacement 1. Press down on the latch, and slide the battery off. 2. Insert the Kingon P2 battery by sliding battery into place until the latch returns to the upper position. 24 Maintenance and Cleaning of Kingon P2 Effect of Temperature on Battery Performance To extend the run-time of your battery, the device should be used in temperatures between 5°C and 35°C. The number of cycles that the battery will last is highly dependent upon the temperature at which the battery is charged. CAUTION Kingon suggests that the room temperature should not exceed 24°C when batteries are being charged. Battery Time Remaining Clock The Kingon P2 continuously displays battery time remaining. This displayed time is only an estimate and the actual time remaining may vary from this value. CAUTION Store battery in a cool, dry place. Store with a charge of 40-50%. Batteries should not be left dormant for more than 90 days at a time. CAUTION If the device is not used for an extended period of time, please remove the battery. Disposal of Equipment and Accessories Follow your local governing ordinances for disposal and recycling of the Kingon P2 accessories. The battery contains lithium ion cells which should be recycled and must not be incinerated. Maintenance Item List Follow your local governing ordinances for disposal and recycling of the Kingon P2 accessories. The battery con- tains lithium ion cells which should be recycled and must not be incinerated. Item Model Number Kingon P2 Standard Battery BA-P200 Pre-Filter FI-P200 Cotton Intake Filter FI-P201 If you need assistance, please contact your equipment provider. 25 System Specifications VI. System Specifications Concentrator Specification Dimensions 22.1L x 16H x 8.5W cm Weight 1.98kg with battery installed Sound Level 42 dB (A) at setting 2 User Interface 2.8 inch LCD colour display screen Warm-Up Time 2 minutes Oxygen Concentration 90% -3% / +6% at all settings Settings 1 2 3 4 5 Breath Rate Pulse Volumes (ml) 10 21 42 63 84 100 15 Flow Control 20 Settings and Pulse Volumes 25 14 28 42 56 66.7 10.5 21 31.5 42 50 8.4 16.8 25.2 33.6 40 30 7 14 21 28 33.3 35 6 12 18 24 28.6 40 5.3 10.5 15.8 21 25 ±15% at STPD* ±25% over the rated environmental range *STPD is 101.3kPa at an operating temperature of 20°C, dry Breathing Frequency 10 to 40 BPM Inspiratory Trigger Sensitivity 0.12cm H20 Maximum Outlet Pressure 25 PSI 26 System Specifications Concentrator Specification - Continued Power: AC Power Supply DC Power Supply Battery Duration Battery Charging Time Environmental Ranges Intended Operation Environmental Ranges Intended for Shipping and Storage Transportation AC input: 100 to 240V | 50 to 60 Hz DC input: 11-16V | DC output: 19V 6.3A Voltage: 14.4V Setting 1: 5h Setting 2: 3h 50min Setting 3: 3h Setting 4: 2h Setting 5: 1h 40min Not more than 4 hours Temperature: 5°C to 40°C Humidity: 10% to 90%, non-condensing Altitude: 0 to 10,000 ft. (0 to 3048 meters, 70kPa to 106 kPa ) Temperature: -20°C to 70°C Humidity: 5% to 90%, non-condensing Altitude: 0 to 10,000 ft (0 to 3048 meters, 70kPa to 106 kPa ) Store in a dry environment Keep dry, handle with care Classifications Mode of Operation Continuous Duty Type of Protection Against Electrical Shock Degree of Protection to Concentrator Components Against Electrical Shock Degree of Protection to Concentrator Components Against Ingress of Water Class II Type BF Not intended for cardiac application IP22 - Protects against solid objects over 12mm and direct sprays of water up to 15° of vertical (IEC 60529) 27 System Specifications Standards Compliance The device is designed to conform to the following standards: - IEC 60601-1-2, 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601 - 1: Medical Electrical Equipment - part 1: General Requirements for Basic safety & Essential Performance - AAMI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic safety and Essential Performance - IEC 60601-1-8 Medical electrical equipment Part 1-8: General Requirements for Basic Safety and Essential Performance Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems - IEC 60601-1-11 Medical electrical equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - ISO 80601-2-67, Medical electrical equipment, Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment - ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment - ISO18562-1: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process - ISO18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter - ISO18562-3: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs) - ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process - AAMI/ANSI/ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Irritation - AAMI/ANSI/ISO 10993-5:2009, biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity 28 System Specifications EMC Information The device has been designed to meet EMC standards throughout its service life. Guidance and Manufacturer's Declaration Electromagnetic Immunity: The concentrator is intended for use in the electromagnetic environment specified below. The user of the concentrator should make sure it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 ±8 kV Contact ±15 kV Air ±8 kV Contact ±15 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical Fast Transient/Burst IEC 61000-4-4 ±2 kV for Power Supply Lines ±1 kV for Input/output Lines ±2 kV for Power Supply Lines ±1 kV for Input/output Lines Mains power quality should be that of a typical home or hospital environment. Surge IEC 61000-4-5 ±1 kV Line to Line ±2 kV Line to ground ±1 kV Line to Line ±2 kV Line to Ground Mains power quality should be that of a typical home or hospital environment. Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000-4-11 <5% UT (>95% Dip in UT) for 0.5 Cycle at 45 degree increments 70% UT (30% Dip in UT) for 0.5 seconds <5% UT (>95% Dip in UT) for 5 seconds <5% UT (>95% Dip in UT) for 0.5 Cycle at 45 degree increments 70% UT (30% Dip in UT) for 0.5 seconds <5% UT (>95% Dip in UT) for 5 Seconds Mains power quality should be that of a typical home or hospital environment. If the user of the device required continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or battery. Power Frequency (50/60Hz) Magnetic Field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home or hospital environment. Note: UT is the A.C. mains voltage prior to application of the test level 29 System Specifications EMC Information - Continued Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz 6 Vrms Amateur Radio & 6 Vrms Amateur Radio ISM Bands between 150 & ISM Bands between kHz and 80 MHz 150 kHz and 80 MHz 10 V/m 10 V/m 80 MHz to 2.7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended 30 cm separation distance. Interference may occur in the vicinity of equipment marked with the following symbol: Guidance and Manufacturer's Declaration Electromagnetic Emissions: The concentrator is intended for use in the electromagnetic environment specified below. The user of the concentrator should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Group 1 Class B Class A Complies The Device 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 device 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. 30 Warranty VII. Warranty Under our warranty conditions we assume the warranty for our Kingon P2 O2 Concentrator for perfect condition and function. The warranty term is 36 months and begins on the day of shipment. Please contact us by telephone or email to return defective equipment under warranty and to resolve problems. Our trained staff will handle any questions and problems with your portable oxygen concentrator. Please make sure that your returned equipment is safe for transportation, and if possible, in its original packaging in order to avoid transport damages. Excluded from the warranty are damages caused by improper usage. Battery replacements, disposable parts and consumables are also excluded from warranty. Sieve bed, filters, batteries in the equipment are expressly excluded from the 36 months warranty, except as provided below: Description Kingon P2 Oxygen Concentrator Other accessories (battery, carry bag, external battery charger, power supplies, and power cord) Sieve Bed Disposables (nasal cannulas, filters) Period 3 Years 1 Year 1 Year No Warranty Further damage compensation claims of any kind, particularly owing to breach of obligations and unpermitted handling, as well as claims on repayment of expenses paid in vain, are not included in the warranty; the same shall apply to claims on repayments of consequential harm caused by a defect. Any further claims are excluded in this warranty. The aforementioned limitations do not apply to claims on damages from harm to life, body or health or attributable to intent or gross negligence, or the product liability law. This warranty does not cover damage or injury whether to Kingon P2 or to personal property or persons caused by accident, misuse, abuse, negligence, failure to install in accordance with Kingon's installation instructions, failure to operate under conditions of normal use and in accordance with the terms of the operating manual and instructions, failure to maintain in accordance with the applicable service manuals, or alteration or any defects not related to materials or workmanship of Kingon P2. This warranty does not cover damage which may occur in shipment. This warranty does not apply to any product or individual part of a product that may have been repaired or altered by anyone other than an authorized medical service center. This warranty does not apply to any product which is not purchased new. 31 WellKang Ltd (www.CE-marking.eu) Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland, UK. Qingdao Kingon Medical Science and Technology Co., Ltd. Manufacturer Address: Room 301-302, No. 15 Hancheng Road, Qingdao Free Trade Zone, Shandong, China, 266555 Factory Address: 24th Factory Building, No. 252 Yanhe Road, Huangdao, Qingdao, Shandong, China, 266510 Tel: +86 532 58792324 Email: kingonmed@gmail.com www.kingonmed.com E&OE. Created 20/1/2025. 32