Rhythm Healthcare P2-E6 User manual

P2-E6 PORTABLE
OXYGEN CONCENTRATOR
ITEM# P2-E6

TABLE OF CONTENTS
Symbols...............................................................................................1-2
Intended Use...........................................................................................3
Contraindications.....................................................................................4
General Precautions.............................................................................4-7
Parts Diagram..........................................................................................8
User Interface Buttons and Display Symbols........................................9-12
Alerts................................................................................................13-15
Power Supply....................................................................................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
Specications...................................................................................28-29
Classications........................................................................................29
Standards Compliance...........................................................................30
EMC Information...............................................................................31-32
Electromagnetic Emissions....................................................................32
Warranty................................................................................................33

1
Symbol Description
WARNING A warning indicates that the personal safety of the patient may be involved.
Disregarding a warning could result in signicant 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
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 ames
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
Manufacturer
Protects against solid objects over 12mm and direct sprays of water up to 15° of
vertical.
Date of manufacture

2
Symbol Description
Serial Number
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.

3
Intended Use, Contraindications and General Precautions
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. 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 Expected Life
P2-E6 Oxygen Concentrator: 5 Years
Molecular Sieve Beds: 2 Years
Batteries: 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.

4
Intended Use, Contraindications and General Precautions
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. Please seek medical
advice before using this device.
• The P2-E6 is not designed or specied to be used in conjunction with a humidier,
nebulizer or connected with any other equipment. Do not modify the P2-E6 Oxygen
Concentrator. Any modications 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 re, 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 ame.
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 conditions.
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 re hazard and
personal injury.
CAUTION
Never leave the P2-E6 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.

5
Intended Use, Contraindications and General Precautions
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 e󰀨ectiveness of
the oxygen therapy.
WARNING
Set the device at the prescribed level and do not increase or decrease your ow rate
without rst consulting with your doctor or healthcare professional.
WARNING
Use this device only as prescribed.
The use of oxygen therapy can be hazardous in some circumstances.
Always consult your health care practitioner before using the POC.
WARNING
The settings of the P2-E6 might not correspond with a continuous ow of oxygen.
WARNING
The settings of other models or brands of oxygen therapy equipment do not correspond
with the settings of the P2-E6.
WARNING
There is a risk of re associated with oxygen equipment and therapy. Do not use near
sparks or open ames.

6
Intended Use, Contraindications and General Precautions
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 re and burns, never use petroleum or oil-based
lotions or salves.
WARNING
Smoking during oxygen therapy is dangerous and may result in re which can cause
serious injury or death of the patient and others.
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 specic 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 congured.
WARNING
Do not lubricate replaceable ttings, connections, tubing, or other accessories of the
oxygen concentrator to avoid the risk of re and burns.
WARNING
Use only spare parts recommended by the manufacturer to ensure proper function and to
avoid the risk of re and burns.
WARNING
Wind or strong drafts can adversely a󰀨ect accurate delivery of oxygen therapy.
Examples include:
• Using this equipment beside an open window or in front of a fan.
• Using this equipment in the back seat of an open convertible car.

7
Intended Use, Contraindications and General Precautions
General Precautions-Continued
WARNING
If any of the following occurs, STOP using immediately and contact your 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 re may start easily if device is used
improperly.
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 o󰀨 when
not in use.
WARNING
To ensure proper function and to avoid the risk of re and burns:
• Use only with P2-E6 AC and DC power supply
• 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 specied may decrease oxygen concentration levels.
WARNING
Do not modify this system or equipment in any way. Modications could result in hazards to
the user.
Note: Additional warnings, cautions, and notes are located throughout the manual.
WARNING
Changes in altitude may a󰀨ect the amount of oxygen supplied by the device. Consult your
physician before travelling to a place with altitude changes.

8
Parts Diagram
Setting Battery Life
1 5.4h
2 4.8h
3 3.3h
4 2.5h
5 2.1h
6 1.7h
Flow Control
Display
System
Information
Nozzle
Fitting
Air Intake
Audible
Alarm
Button
Alert/Alarm Light
Breath Detection Light
On/O󰀨 Button
Battery
Power Input
Interface
Air Exhaust
Air Intake

9
User Interface Buttons and Display Symbols
Display Panel
Symbol Description Instructions
On/O󰀨
Button
Press once to turn On.
Press and hold for one second to turn O󰀨.
Audio Alarm
Button
Press once to toggle between audible and silent mode.
The panel will display the appropriate icon to indicate
which mode is enabled:
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.
Flow Setting
Control Buttons
Increase or decrease the oxygen ow
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,
molecular sieve temperature, molecular sieve runtime,
device model, device temperature, device runtime,
rmware version, hardware version.

10
User Interface Buttons and Display Symbols
Home Screen
Icon Description
Current ow setting
(range is 1 to 6)
Battery charge level:
• Battery percentage remaining
• Battery time remaining
(hours: minutes)
Device runtime since powered on:
(hours: minutes)
Alerts are silenced
Audible Alerts are on
The screen will also display the following icons (see next page):

11
User Interface Buttons and Display Symbols
Icon Description
Powered by AC or DC only
1. Powered by battery only (not plugged in and charging)
2. Battery level percentage and time remaining
(hours: minutes).
3. Device 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 O󰀨.
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 (hours: minutes) since it was powered on
(Example displays 2 hours 35 minutes).
Multiple alerts have been detected.
Display will scroll to display all alerts.

12
User Interface Buttons and Display Symbols
Audible Mode:
Below shows the device has detected an active alarm while in Audible Mode.
Example below shows "Absence of Breath”.
Alerts 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":

13
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 unit is turned On or O󰀨.
Alarm audio pulse duration:
An audible alert (if enabled) will pulse between 150ms On,150ms o󰀨, repeat 2 times.
Alarm audio pulse group interval:
15.5s (until Alarm returns to normal)
Alarm details:
Reference the table below for additional alarm details.

14
Alerts-Continued
Alarm item Alarm condition System process Display of screen
Battery
Exhausted
Battery cycle >500
Or battery health <50% Alarm only Battery is Exhausted. Replace Battery
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 more
than 15 seconds
Alarm only Absence of Breath
Check Cannula
Oxygen
Concentration <87%
Concentration <87%
continuously for more
than 300 seconds
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 more
than 300 seconds
Auto-shut down
after 30 seconds
Low O2: <50%
Contact Provider
Breath Sensor
Fail Breath Sensor failed Auto-shut down after 30 seconds
Breath Sensor Fail
Contact Provider
Oxygen Sensor
Fail Oxygen Sensor failed Auto-shut down after 30 seconds
Oxygen Sensor Fail
Contact Provider
Gas Delivery Fail No delivery detected
after injection
Auto-shut down
after 30 seconds
Gas Delivery Fail
Contact Provider
Gas Obstruction Pipe or nasal blocked Auto-shut down
after 30 seconds
Gas Obstruction
Contact Provider
Tank Pressure
Fail Tank pressure failed Auto-shut down after 30 seconds
Tank Pressure Fail
Check Provider

15
Alerts-Continued
Alarm item Alarm condition System process Display of screen
Sieve Bed Fail Sieve Bed failure
or invalid
Auto-shut down
after 10 seconds
Sieve Bed Fail
Contact Provider
Compressor Fail Compressor failed Auto-shut down
after 10 seconds
Compressor Fail
Contact Provider
Valve Check Fail Valve switch failed Auto-shut down
after 10 seconds
Valve Check Fail
Contact Provider
Cooling Fan Fail Cooling fan failed Auto-shut down
after 10 seconds
Cooling Fan Fail
Contact Provider
Battery Depleted RSOC 5%
Without adapter
Auto-shut down
after 10 seconds
Battery Depleted
Replace battery/
Connect to adapter
System Cold System Temperature
<32°F/0°C
Auto-shut down
after 10 seconds
System Cold
Shut down, Move to
warmer place
Battery Cold Battery Temperature
<32°F/0°C
Auto-shut down
after 10 seconds
Battery Cold
Shut down, Move to
warmer place
System Hot System Temperature
>140°F/60°C
Auto-shut down
after 10 seconds
System Hot
Shut down, Move to
cooler place
Battery Hot Battery Temperature
>149°F/65°C
Auto-shut down
after 10 seconds
Battery Hot
Shut down, Only use
adapter
Power Supply
Fail
System voltage
<10.5v
Auto-shut down
after 10 seconds
Power Supply Fail
Contact Provider
Gas Supply Fail
Flow or concentration
below normal after
injection
Auto-shut down
after 10 seconds
Gas Supply Fail
Contact Provider
Sys Startup Fail
Concentration less
than 87%
continuously >15s
after system startup
Auto-shut down
after 10 seconds
System Startup Fail
Contact Provider

16
Power Supply
Standard Lithium-lon Battery # P2BY001-2
The P2-E6 is powered by a standard lithium-ion battery. When fully charged the battery
can provide 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 # P2ACA-1
The AC power supply is used to power the P2-E6 Oxygen Concentrator from 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
through out 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 # P2DCA-2
The DC power supply is designed for use with the P2-E6 Oxygen Concentrator. The DC
power input cable connects directly to the car cigarette lighter or auxiliary DC power supply.
The input DC power is 11-16Vdc, and fuse rating is 15A /125V, output is 19V 6.3A.

17
WARNING
Do not use power supplies/adapters or accessories other than those specied above.
The use of non-specied accessories may create a safety hazard and/or impair
equipment performance.
Accessories
Nasal Cannula # P2NC-1
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. DO NOT use a cannula that
has a length exceeding 25ft (7.6m).
CAUTION
When using a long cannula, the ow 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.
CAUTION
Select only FDA approved nasal cannula (e.g. P2NC-1)
Carry Bag # P2CB-1
The P2-E6 carry bag allows you to go out for daily activities.