Rhythm Healthcare P2-E6 User manual

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 ................................................................................................... 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
Specifications ............................................................................................. 28-29
Classifications .................................................................................................. 29
Standards Compliance .................................................................................... 30
EMC Information ........................................................................................ 31-32
Electromagentic 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 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.
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
Manufacturer
Protection against falling water drops
Date of manufacture

2
Symbol
Description
Serial Number
This side up
Fragile
Storage Humidity (Non-condensing)
Storage Temperature
MR unsafe

Intended Use, Contraindications and General Precaution
3
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: 1 Year
Batteries: 500 full charge/discharge cycles
CAUTION
The expected life is depending on the environment of usage and the maintenance. Bad
conditions will shorten the lifetime of the concentrator.
WARNING
The operator should read and understand this entire manual before using the device.

Intended Use, Contraindications and General Precaution
4
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 specified to be used in conjunction with a humidifier, nebulizer or
connected with any other equipment. Do not modify the P2-E6 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 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 fire 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.

Intended Use, Contraindications and General Precaution
5
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.
WARNING
Set the device at the prescribed level and do not increase or decrease your flow rate
without first 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
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 by the manufacturer.
WARNING
The settings of the P2-E6 might not correspond with a continuous flow 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 fire associated with oxygen equipment and therapy. Do not use near
sparks or open flames.
General Precautions - continued

Intended Use, Contraindications and General Precaution
6
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.
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 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 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. 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.
General Precautions - continued

Intended Use, Contraindications and General Precaution
7
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.
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 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 may decrease oxygen concentration levels
WARNING
Do not modify this system or equipment in any way. Modifications could result in hazards to
the user.
Note: Additional warnings, cautions, and notes are located throughout the manual.
WARNING
Changes in altitude may affect the amount of oxygen supplied
=
by the device. Consult your physician before travelling to a place with altitude changes.
General Precautions - continued

8
Parts Diagram

9
User Interface Buttons and Display Symbols
Display Panel:
Symbol
Description
Instructions
ON I OFF
Button
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.
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,
molecular sieve temperature, molecular sieve runtime,
device model, device temperature, device runtime,
firmware version, hardware version.

10
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):

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)
1. 2. Battery level percentage and time remaining
(in hours:minutes).
2. 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 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 alerts have been detected.
Display will scroll to display all alerts.

12
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"):

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 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.
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 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 cannula
Oxygen
concentration<87
Concentration < 87%
continuously > 300S
Alarm only
Low O2:< 87%
Pls Contact provider
Low Battery
5%!≦ RSOC!≦!20%
Without adapter
Alarm only
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 down after 30s
Gas Delivery Fail Pls
Contact provider
Gas Obstruction
Pipe or nasal
blocked
shut down after 30s
Gas Obstruction Pls
Contact provider
Tank Pressure
Fail
Tank pressure failed
shut down after 30s
Tank Pressure Fail
Pls Check cannula
Sieve Bed Fail
Sieve Bed failure
or invalid
shut down after 10s
Sieve Bed Fail
Pls Contact provider
Compressor Fail
Compressor failed
shut down after 10s
Compressor Fail
Pls Contact Provider

15
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
System temperature <
32°F/0°C
shut down after
10s
System Cold:
Pls Shut down, Move
to warmer place
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 after
10s
Gas Supply Fail:
Pls Contact Provider
System Startup
Fail
Concentration less
than 87%
continuously > 15S
after system startup
shut down after
10s
System Startup Fail:
Pls Contact Provider
Power Supply
Fail
System voltage
< 10 5v
shut down after
10s
Power Supply Fail:
Pls Contact Provider

16
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 # EM11012E
The AC power supply (EM11012E) 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 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 # ED1010C
The DC power supply (ED1010C) 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 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. 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.
CAUTION
Select only CE approved nasal cannula (e.g. Runmai NOC-DAW0721)
Carry bag # CB-P200
The P2-E6 carry bag allows you to go out for daily activities.

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