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TABLE OF CONTENTS

Symbols

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1-2

Intended Use

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Contraindications

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General Precaution

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4-7

Parts Diagram

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User Interface Buttons and Display Symbols

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9-12

Alerts

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13-15

Power Supply

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16-17

Accessories

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17-18

General Operation

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19-2

Troubleshooting

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Cleaning the Case

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Cannula Replacement

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Filter Cleaning and Replacement

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-2

Battery Care and Maintenance

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-2

Disposal of Equipment and Accessories

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Replacement Parts

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Specifications

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Classifications

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Standards Compliance

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EMC Information

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-3

Electromagentic Emissions

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Warranty

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Содержание P2-E6

Страница 1: ...ITEM P2 E6 P2 E6 PORTABLE OXYGEN CONCENTRATOR ...

Страница 2: ...ply 16 17 Accessories 17 18 General Operation 19 22 Troubleshooting 23 Cleaning the Case 24 Cannula Replacement 24 Filter Cleaning and Replacement 24 25 Battery Care and Maintenance 25 26 Disposal of Equipment and Accessories 27 Replacement Parts 27 Specifications 28 29 Classifications 29 Standards Compliance 30 EMC Information 31 32 Electromagentic Emissions 32 Warranty 33 ...

Страница 3: ... caution could lead to a minor injury or damage to equipment See User Manual for Instructions AC Power DC Power 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 Class II Double Insulated See Instructions for Use Manufactu...

Страница 4: ...2 Symbol Description Serial Number This side up Fragile Storage Humidity Non condensing Storage Temperature MR unsafe ...

Страница 5: ...ems 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 liab...

Страница 6: ... 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 P2 E6 or any of the accessories in liquid Do not expose to water or precipitation Do not operate in the rain wet weather ...

Страница 7: ... some circumstances Always consult your health care practitioner before using the POC WARNING To ensure that you receive the correct therapeutic amount of oxygen delivery according to your medical condition the P2 E6 Must be used only after one or more settings have been individually determined or prescribed for you at your specific levels Must only use the parts and accessories that are provided ...

Страница 8: ...ve been individually determined or prescribed for you at your specific activity levels Must use only the parts and accessories that were provided by the manufacturer and those that were used while your personalized 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...

Страница 9: ...WARNING To ensure proper function and to avoid the risk of fire and burns Use only with P2 E6 AC and DC power supplys Use only with P2 E6 batteries Use only approved P2 E6 accessories WARNING Remove the battery from the device if the P2 E6 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...

Страница 10: ...8 Parts Diagram ...

Страница 11: ...ible 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 Flow Setting Control Buttons Increase or decrease the oxygen flow setting by pressing or Flow settings range from 1 to 6 Device Information Press to display information about the device including battery temperature battery status molecu...

Страница 12: ...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 ...

Страница 13: ...age 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 in hours minutes since it was powered on sample shows 2 hours 35 minutes Multiple...

Страница 14: ...lay 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 ...

Страница 15: ...y 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 Alarm audio pulse group interval 15 5s until Alarm returns to normal Alarm details Reference the table below for additiona...

Страница 16: ...ly Low Battery Pls Charge now Oxygen concentration 50 Concentration 50 continuously 300S shut down after 30s Low O2 50 Pls Contact provider Breath Sensor Fail Breath Sensor failed shut down after 30s Breath Sensor Fail Pls Contact provider Oxygen Sensor Fail Oxygen Sensor failed shut down after 30s Oxygen Sensor Fail Pls Contact provider Gas Delivery Fail No delivery detected After injection shut ...

Страница 17: ... Battery Cold Battery temperature 32 F 0 C shut down after 10s Battery Cold Pls Shut down Move to warmer place System Hot System temperature 140 F 60 C shut down after 10s System Hot Pls Shut down Move to cooler place Battery Hot Battery temperature 149 F 65 C shut down after 10s Battery Hot Pls Shut down Only use adapter Gas Supply Fail Flow or concentration below normal after injection shut down...

Страница 18: ...om an AC power source When using the AC charger the power supply automatically adapts to input voltages from 100V to 240V 50 60HZ allowing it to be used with most power sources throughout the world 1 Connect A plug to nearest AC power outlet 2 Connect C to D port 3 Connect B to the P2 E6 DC Power Supply E D 1010C The DC power supply ED1010C is designed for use with the P2 E6 Oxygen Concentrator Th...

Страница 19: ...en 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 that has a length exceeding 25ft 7 6m CAUTION When using a long cannula the flow setting may need to be increased Increasing the cannula length may reduce the perceived noise during oxygen bolus delivery CAUTION The nasal cannula is designed for disposable use CA...

Страница 20: ...18 Accessories List Item Qty NO Nasal Cannula 1 pc NOC DAW0721 Carry Bag 1 pc CB P200 AC power supply 1 pc EM11012E DC power supply 1 pc ED1010C Intake Filter 5 pc FI P201 Battery 1 pc BA P201 ...

Страница 21: ... 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 P2 E6 Concentrator is designed for continuous use It is useful to operate the product frequently for optimal sieve bed life CAUTION P2 E6 is shipped from factory with battery removed Ensure the particle ...

Страница 22: ...er 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 Avoid the use of electrical extension cords with the P2 E6 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...

Страница 23: ...and the indicator light will flash Welcome will appear on the display while the concentrator starts up The display will indicate the selected flow setting and power condition A two minute warm up time will initiate During this period the oxygen concentration is building to the specified value but may not have yet reached specification Under special conditions a longer warm up time may be necessary...

Страница 24: ...he device will begin delivering pulses based on your breathing As your breathing rate changes the P2 E6 will sense these changes and adjust the amount of oxygen at your next inhale WARNING If you feel discomfort using the device consult your doctor immediately CAUTION A Low O2 87 alert will display on the screen if the oxygen level drops below recommended levels If the alarm persists contact your ...

Страница 25: ... properly Check AC power connection and verify solid green light on adapter DC Cable is not connected properly Check DC power connection and at cigarette lighter or auxiliary DC power source No Oxygen The device is not turned on Turn on the concentrator Cannula is kinked or obstructed Check cannula and its connection to the oxygen outlet port Equipment failure Contact your provider Oxygen not at f...

Страница 26: ...a is disposable You can buy replacements from your physician or provider and follow the cannula manufacturer s instructions CAUTION Nasal cannula should be rated for 5 liters per minute to ensure proper patient usage and oxygen delivery Filter Cleaning and Replacement Filters are designed for adequate air flow through the device at the front of the P2 E6 Pre Filter FI P202 The particle screen pre ...

Страница 27: ...ters 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 Use only P2 E6 batteries BA P201 with your concentrator CAUTION Keep liquids away from batteries If batteries get wet stop using immediately and dispose of battery properly Battery Replacement 1 Press down on the latch and slide the ba...

Страница 28: ...s charged Battery Time Remaining Clock The P2 E6 continuously displays the battery time remaining This displayed time is only an estimate and the actual time remaining may vary from this value CAUTION We suggest that the room temperature should not exceed 75 F 24 C when batteries are being charged Store battery in a cool dry place Store with a charge of CAUTION 40 50 Batteries should not be left d...

Страница 29: ...rdinances 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 Model No P2 E6 standard battery BA P201 Pre Filter FI P202 Intake Filter FI P201 If you need assistance contact your provider ...

Страница 30: ...ings and Pulse Volumes Settings 1 2 3 4 5 6 Breath Rate Pulse Volumes ml 10 21 42 63 84 100 120 15 14 28 42 56 66 7 80 20 10 5 21 31 5 42 50 60 25 8 4 16 8 25 2 33 6 40 48 30 7 14 21 28 33 3 40 35 6 12 18 24 28 6 34 40 5 3 10 5 15 8 21 25 30 15 at STPD 25 over the rated environmental range STPD is 101 3 kPa at an operating temperature of 68 F dry Breathing Frequency 10 to 40 BPM Inspiratory Trigge...

Страница 31: ...o 10 000 ft 0 to 3048 meters 70kPa to 106 kPa Environmental Ranges Intended for Shipping and Storage Temperature 4 F 158 F 20 C 70 C Humidity 5 to 90 No condensing Store in a dry environment Altitude 0 to 10 000 ft 0 to 3048 meters 70kPa to 106 kPa Transportation Keep Dry Handle With Care Classifications Mode of Operation Continuous Duty Type of Protection Against Electrical Shock Class II Degree ...

Страница 32: ...equipment and medical electrical systems used in the home healthcare environment ISO 80601 2 67 Medical electrical equipment Part 2 67 Requirements for basic safety and essential performance of oxygen conserving equipment ISO 80601 2 69 Medical electrical equipment Part 2 69 Requirements for basic safety and essential performance of oxygen concentrator equipment ISO18562 1 2017 Biocompatibility ev...

Страница 33: ...ypical 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 supply should be that of a typical home or hospital environment 5 UT 95 Dip in UT for 0 5 Cycle at 45 degree increments 70 U T 30 Dip in UT for 0 5 seconds 5 UT 95 Dip in UT for 5 Seconds 5 UT 95 Main power supply should be that of a typical home or hospita...

Страница 34: ...rer s Declaration Electromagnetic Emissions The P2 E6 is intended for use in the electromagnetic environment specified below The user of the P2 E6 should ensure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The P2 E6 uses RF energy only for its internal function Therefore its RF emissions are very low and are not like...

Страница 35: ...gations 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...

Страница 36: ...Rhythm Healthcare LLC 3200 Tyrone Blvd N St Petersburg FL 33710 Email contactus rhythmhc com Website www rhythmhc com V1 08 08 22 ...

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