ITEM# P2-E6 P2-E6 PORTABLE OXYGEN CONCENTRATOR
TABLE OF CONTENTS Symbols ...........................................................................................................1-2 Intended Use ...................................................................................................... 3 Contraindications ............................................................................................... 4 General Precaution......................................................................................... 4-7 Parts Diagram ...............
Symbol Description WARNING A warning indicates that the personal safety of the patient may be involved. Disregarding a warning could result in significant injury. CAUTION A caution indicates that a precaution or service procedure must be followed. Disregarding a caution could lead to a minor injury or damage to equipment. See User Manual for Instructions.
Symbol Description Serial Number This side up Fragile Storage Humidity (Non-condensing) Storage Temperature MR unsafe 2
Intended Use, Contraindications and General Precaution Intended use: The P2-E6 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 P2-E6 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.
Intended Use, Contraindications and General Precaution Contraindications CAUTION • This device is not intended to be life sustaining or life supporting. • 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. • In certain circumstances, oxygen therapy can be hazardous.
Intended Use, Contraindications and General Precaution General Precautions - continued WARNING If you feel any discomfort or are experiencing a medical emergency while using this product, seek medical assistance immediately to avoid harm. WARNING Reassess the oxygen delivery settings of this POC periodically to ensure effectiveness of the oxygen therapy.
Intended Use, Contraindications and General Precaution General Precautions - continued WARNING Use only water-based lotions or skin creams that are oxygen compatible during setup or using oxygen therapy. To avoid the risk of fire and burns, never use petroleum or oil-based lotions or salves. WARNING Smoking during oxygen therapy is dangerous and may result in fire which can cause serious injury or death of the patient and others.
Intended Use, Contraindications and General Precaution General Precautions - continued WARNING If any of the following occurs, 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 enclosure WARNING Oxygen is a combustion supporting gas, a fire may start easily if device is used improperly.
Parts Diagram 8
User Interface Buttons and Display Symbols Display Panel: Symbol Description ON I OFF Button Instructions Press once to turn "ON”. Press and hold for one second to turn "OFF" Press once to toggle between audible and silent mode. The panel 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 display on the screen. Press this button to mute or unmute alarms.
User Interface Buttons and Display Symbols Home Screen Home screen will show the icon as: Icon Description Current flow setting (range is 1 to 6) Battery charge level: • Battery percentage remaining • Battery time remaining (in hours:minutes) Device runtime since powered on (in hours:minutes) Alerts are silenced Alerts are audible Additionally, screen will also display the following icons (see next page): 10
User Interface Buttons and Display Symbols ICON DESCRIPTION Powered by AC or DC only 1. 1. 2. Powered by battery only (not plugged in and charging) Battery level percentage and time remaining (in hours:minutes). 2. 3. Device ON 1. 2. 3. 1. 2. 3. Battery is charging. Battery level percentage and estimated time to fully charge the battery. Device is ON. Battery is charging. Battery level percentage and estimated time to fully charge the battery. Device is OFF.
User Interface Buttons and Display Symbols Audible Mode: The display below shows that the device has detected an active alarm while in Audible Mode (example below shows "Absence of Breath"): Alert in Silent Mode: The display below shows that the device has detected an active alarm while in Silent Mode (example below shows "Absence of Breath"): 12
Alerts Adapter plug / unplug: An adapter icon displays when adapter is plugged in and disappears when unplugged. An audible alarm (if enabled) will also be heard. Battery plug / unplug A battery icon displays when battery is connected and disappears when disconnected. An audible alarm (if enabled) will also be heard. Alarm audio selection: An alert will indicate when unit is turned on or off. Alarm audio pulse duration: An audible alert (if enabled) will pulse between 150ms On, 150ms off, repeat 2 times.
Alerts-continued 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 Pls Contact provider Low Input Voltage Adapter input < 17 0v Switch battery supply until adapter input >18 Low Input Voltage Pls Check Adapter Absence Of Breath No breath detected continuously > 15S Alarm only Absence of Breath Pls Check cannul
Alerts - continued Alarm item Alarm condition System process Display of screen Valve Check Fail Valve switch failed shut down after 10s Valve Check Fail: Pls Contact Provider Cooling Fan Fail Cooling fan failed shut down after 10s Cooling Fan Fail: Pls Contact Provider Battery Depleted RSOC: ! 5% Without adapter shut down after 10s Battery Depleted: Replace battery or connect to adapter System Cold Battery Cold System Hot Battery Hot Gas Supply Fail System Startup Fail Power Supply Fail
Power Supply Standard Lithium-Ion Battery # BA-P201 The P2-E6 is powered by a standard lithium-ion battery. When fully charged, the battery can last for up to 5.4 hours of operation. Recharge the battery with the AC or DC adapter. Recharging time is not more than 4 hours. AC Power Supply # E M 11012E The AC power supply (EM11012E) is used to power the P2-E6 Oxygen Concentrator from an AC power source.
WARNING Do not use power supplies or power cables other than the specified above. Do not use power supplies /adapters or accessories other than those specified above. The use of non-specified accessories may create a safety hazard and/or impair equipment performance. Accessories Nasal Cannula The P2-E6 Oxygen Concentrator 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.
Accessories List Item Nasal Cannula Carry Bag AC power supply DC power supply Intake Filter Battery Qty 1 pc 1 pc 1 pc 1 pc 5 pc 1 pc NO# NOC-DAW0721 CB-P200 EM11012E ED1010C FI-P201 BA-P201 18
Operating Instructions General Operation 1. Find a well-ventilated location to place the P2-E6, make sure it's turned off. Be sure the Intake and exhaust has clear access. Put the P2-E6 in a suitable place where any alarms can be heard. WARNING Do not use P2-E6 in the presence of flammable anesthetics, detergents, or other chemical vapors. CAUTION Do not block the air intake or air exhaust when operating the equipment.
Operating Instructions General Operation-continued 2. Install the battery. Slide the battery into place until the latch returns to the upper position. There will be an audible sound when the battery is in position. 3. Connect the AC or DC power to P2-E6. The green LED on the power adapter will turn on and there will be an audible sound when power is connected. CAUTION Do not place anything in the power supply port other than the supplied wall cord.
Operating Instructions General Operation-continued 4. Connect the nasal cannula to the nozzle fitting. Nozzle fitting is located on the top side of the P2-E6 near the pre-filter. Connect a nasal cannula to the nozzle fitting on the device. (pictured) CAUTION Ensure that the cannula is routed to prevent it from being pinched or kinked to avoid a disruption of oxygen flow. CAUTION The cannula is designed for disposable use. 5. Switch on P2-E6 with a short press of the ON/OFF Button.
Operation Instructions General Operation-continued 6. Set to the flow rate prescribed by your physician or clinician. Press the + or - setting buttons to adjust the P2-E6 to the desired flow rate. The current setting can be viewed on the display from 1 to 6. CAUTION Make sure the power is in a well-ventilated place. During operation, the power supply may get hot. Make sure the power supply is cool before handling. 7. Wear the nasal cannula on your face and breathe through your nose.
Troubleshooting The table below lists some common problems and solutions. If you can't resolve a problem, please contact your provider. Problem Device Won't Turn On No Oxygen Oxygen not at full concentration Alarm Occurs Possible Cause Recommended Solution Battery is not installed correctly Remove the battery and re-install it correctly. Battery is depleted Use the AC or DC power adapter to operate the device (with the battery inserted) to recharge the battery.
Maintenance and Cleaning of P2-E6 Cleaning the Case The outside case should be cleaned using a damp cloth 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 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 disposable.
Maintenance and Cleaning of P2-E6 Intake Filter # FI-P201 The intake filter is designed to ensure the clean air into the compressor. 1. Lift the particle screen up by the bottom end then remove it. 2. Take out of the intake filter from the intake chamber. 3. Put a new intake filter into the chamber. 4. Install pre filters. Pre and intake filters can be purchased from your provider. Battery Care and Maintenance The P2-E6 Lithium-Ion Battery requires special care to ensure proper performance and long life.
Maintenance and Cleaning of P2-E6 Battery Care and Maintenance-Continued Effect of Temperature on Battery Performance To extend the run-time of your battery, the device should be used in temperatures between 41° F(5°C) and 95° F(35°C). The number of cycles that the battery will last is highly dependent upon the temperature at which the battery is charged. CAUTION We suggest that the room temperature should not exceed 75°F (24°C) when batteries are being charged.
Maintenance and Cleaning of P2-E6 Disposal of Equipment and Accessories Follow your local governing ordinances for disposal and recycling of the P2-E6 accessories. The battery contains lithium-ion cells and should be recycled and must not be incinerated. P2-E6 Replacement Items Item P2-E6 standard battery Pre Filter Intake Filter Model No. BA-P201 FI-P202 FI-P201 If you need assistance, contact your provider.
System Specifications P2-E6 Portable Oxygen Concentrator Specifications Dimensions L/W/H:8.70” x 3.35” x 6.30” 22.1cm x 8.5cm x 16.0cm 4.37 pounds 1.98Kg (with battery) 2.8” LCD color display screen 49 dB (A) (on setting 2) Weight User Interface Sound Level Time from Turning on the Concentrator 2 minutes to Reach Stated Performance Oxygen 90% - 3% /+ 6% at all settings Concentration Settings 1 2 3 4 5 6 Breath Pulse Volumes(ml) Rate 10 21 42 63 84 100 120 15 14 28 42 56 66.7 80 20 10.5 21 31.
System Specifications Concentrator Specifications-Continued Power: AC Power supply DC Power supply Rechargeable Battery Battery Duration AC Input: 100 to 240VAC 50 to 60 Hz DC Input: 11-16VDC DC Output: 19V 6.3A Voltage: 14.4VDC Rated capacity:6.7Ah Up to 5.4 hours at setting 1 Up to 1.5 hours at setting 6 Battery Charging Time Not more than 4 hours Environmental Ranges Intended for Operation Temperature: 41˚F - 104˚F (5˚C - 40˚C) Humidity: 10% to 90%, non-condensing Altitude: 0 to 10,000 ft.
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 B
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.
System Specifications EMC Information-Continued Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 6 Vrms Amateur Radio & ISM Bands between 150 kHz and 80 MHz 6 Vrms Amateur Radio & ISM Bands between 150 kHz and 80 MHz Radiated RF 10 V/m 10 V/m IEC 61000-4-3 80 MHz to 2.7 GHz Portable and mobile RF communications equipment should not be used closer (to any part of the device, including cables) than the recommended 11.
Warranty The P2-E6 Oxygen Concentrator warranty covers the repair or replacement of the unit. The warranty term is 36 months from the date of shipment. Please contact us by telephone or email to return defective equipment under warranty and to resolve any problems. Our trained technicians will help you with any questions or problems with your POC. Please make sure that your returned equipment is packaged safely for transportation, if possible, in its original packaging to avoid damages during shipping.
Rhythm Healthcare, LLC 3200 Tyrone Blvd N St. Petersburg, FL 33710 Email: contactus@rhythmhc.com Website: www.rhythmhc.
