Kingon P2 Portable Oxygen Concentrator

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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 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 BACKUP 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
  In 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.

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 dis-comfort 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 con-nected with any other equipment. Do not modify the Kingon P2 Portable Oxygen Concentrator. Any mod-ifications performed on the equipment may impair performance or damage equipment and will void your warranty.

General Precautions

• WARNING
  Oxygen supports combustion. To avoid the 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.
• WARNING
  The oxygen delivery settings of the oxygen concentrator should be periodically reassessed to ensure the 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 the 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 use 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.
• 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 the 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 it 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 the 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 the Kingon P2 will not be used for an extended period
• 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.

Description of the Kingon P2 Oxygen Concentrator

Parts Diagram

User Interface Buttons and Display Symbols

Display Panel

User Interface Buttons and Display Symbols

Home Screen

The screen will also display the following icons (see the next page):

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”.

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.

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 bed chip error	Alarm only	Replace Sieve Bed Contact Provider
Low Input Voltage	Adapter input <17.0v	Auto switch to battery until the adapter input >18v	Low Input Voltage 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 the adapter
System Cold	System temperature <0℃	Shutdown after 10s	System Cold Shut down, move to a warmer place
Battery Cold	Battery temperature <0℃	Shutdown after 10s	Battery Cold Shut down, move to a 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 an adapter
Gas Supply Fail	Flow or concentration below normal after injection	Shutdown after 10s	Gas Supply Fail Contact Provider
Sys Startup Fail	Concentration < 87% continuously >15s after system startup	Shutdown after 10s	Sys Startup Fail Contact Provider
Power Supply Fail	System voltage <10.5v	Shutdown after 10s	Power Supply Fail Contact Provider

Power Supply
Standard Lithium-Ion Battery # BA-P200
The Kingon P2 is powered by a 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 the nearest AC power outlet → connect the C plug to the D port → connect the B plug to the Kingon P2

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.

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	Quantity	Model Number
Nasal Cannula	1 pc	NOC-DAW0721
Carry Bag	1 pc	CB-P200
AC Power Supply	1 pc	EM11012E
DC Power Supply	1 pc	ED1010C
Battery	1 pc	BA-P200
Intake Filter	5 pc	FI-P201

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.
   1. WARNING
      Do not use the Kingon P2 in the presence of flammable anesthetics, detergents, or other chemical vapours.
   2. 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.
   3. CAUTION
      The Kingon P2 concentrator is designed for continuous use. It is useful to operate the device frequently for optimal sieve bed life.
   4. CAUTION
      The Kingon P2 is shipped from the factory with the battery removed.
   5. 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.
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.
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 turning 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.
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 doctor 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 en-abled 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.

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
The device won’t turn on	The battery is not installed correctly	Remove the battery and reinstall it correctly.
	The battery is depleted	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.
	The AC supply is not connected properly	Check the 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.
No oxygen	The device is not turned on	Turn on the concentrator.
	The cannula is kinked or obstructed	Check the cannula and its connection to the oxygen outlet port.
	Equipment failure	Contact your equipment provider.
Oxygen is 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 the previous section – Alerts.

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 provide 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.

Intake Filter
The intake filter is designed to ensure that 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 en,d then remove it.
3. Remove the cotton intake filter from the intake chamber.
4. Replace the new intake filter in 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.

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 contains 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.

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
Flow Control Settings and Pulse Volumes	Settings
		1	2	3	4	5
	Breath Rate	Pulse Volumes (ml)
	10	21	42	63	84	100
	15	14	28	42	56	66.7
	20	10.5	21	31.5	42	50
	25	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

Power: AC Power Supply DC Power Supply	AC input: 100 to 240V | 50 to 60 Hz DC input: 11-16V | DC output: 19V 6.3A Voltage: 14.4V
Battery Duration	Setting 1: 5h Setting 2: 3h 50min Setting 3: 3h Setting 4: 2h Setting 5: 1h 40min
Battery Charging Time	Not more than 4 hours
Environmental Ranges Intended Operation	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 )
Environmental Ranges Intended for Shipping and Storage	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
Transportation	Keep dry, handle with care

Classifications

Mode of Operation	Continuous Duty
Type of Protection Against Electrical Shock	Class II
Degree of Protection to Concentrator Components Against Electrical Shock	Type BF Not intended for cardiac application
Degree of Protection to Concentrator Components Against Ingress of Water	IP22 – Protects against solid objects over 12mm and direct sprays of water up to 15° of vertical (IEC 60529)

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 elec-trical 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

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	Main 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	Main 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	Main power quality should be that of a typical home or hospital environment. If the user of the device requires 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

EMC Information – Continued

Conducted RF IEC 61000-4-6   Radiated RF IEC 61000-4-3   Radiated RF	3 Vrms 150 kHz to 80 MHz   6 Vrms Amateur Radio & ISM Bands between 150 kHz and 80 MHz   10 V/m	3 Vrms 150 kHz to 80 MHz   6 Vrms Amateur Radio & ISM Bands between 150 kHz and 80 MHz   10 V/m	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:
IEC 61000-4-3	80 MHz to 2.7 GHz

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	Group 1	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.
RF Emissions CISPR 11	Class B	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.
Harmonic Emissions IEC 61000-3-2	Class A
Voltage Fluctuations/Flicker Emissions IEC 61000-3-3	Complies

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 damage.
Excluded from the warranty are damages caused by improper usage. Battery replacements, disposable parts, and consumables are also excluded from warranty. Sieve bed, filters, and batteries in the equipment are expressly excluded from the 36-month warranty, except as provided below:

Description	Period
Kingon P2 Oxygen Concentrator	3 Years
Other accessories (battery, carry bag, external battery charger, power supplies, and power cord)	1 Year
Sieve Bed	1 Year
Disposables (nasal cannulas, filters)	No Warranty

Further damage compensation claims of any kind, particularly owing to breach of obligations and unpermitted han-dling, 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 from 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 mate-rials or workmanship of Kingon P2. This warranty does not cover damage that may occur during 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 that is not purchased new.

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.

FAQ

• Q: Can I use the Kingon P2 Portable Oxygen Concentrator without a prescription?
  A: In most countries, this device must be purchased with a doctor’s prescription to ensure proper usage and safety.
• Q: How often should I clean the filters?
  A: Filters should be cleaned or replaced as needed, following the guidelines provided in the user manual.

Documents / Resources

Kingon P2 Portable Oxygen Concentrator [pdf] User Manual P2 Portable Oxygen Concentrator, P2, Portable Oxygen Concentrator, Oxygen Concentrator

References

• User Manual