RHYTHM HEALTHCARE P2-E7 Portable Oxygen Concentrator User Manual

RHYTHM HEALTHCARE P2-E7 Portable Oxygen Concentrator

Specifications

• Item Number: P2-E7
• Product: P2-E7 Portable Oxygen Concentrator
• Storage Humidity (Non-condensing)
• Storage Temperature
• Magnetic Resonance unsafe
• Type BF Applied Part
• Class II (Double Insulated)

Product Information
The P2-E7 Oxygen Concentrator is a portable device prescribed for patients requiring supplemental oxygen. It provides a high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The device is small, portable, and suitable for home use as well as for daily activities.

Warnings

• This device is not intended to be life-sustaining or life-supporting.
• A backup oxygen source is recommended for power outages or mechanical problems.

Cautions

• In most countries, this device must be purchased with a doctor’s prescription.
• It is the responsibility of the patient to have a backup oxygen supply when traveling.

Service Life

Expected Life

• P2-E7 Oxygen Concentrator: 5 Years
• Sieve Beds: 2 Years
• Batteries: 500 full charge/discharge cycles

The actual lifespan depends on the usage environment and maintenance practices.

Symbols

Intended Use, Contraindications and General Precautions

Intended Use

The P2-E7 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-E7 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 or infant use.

WARNING
A backup oxygen source is recommended for power outages or mechanical problems. Ensure that you have a readily accessible backup oxygen source as advised by your healthcare professional or doctor.

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 backup arrangements for an alternative oxygen supply when traveling. We assume no liability for persons who do not adhere to manufacturer recommendations.

Service Item

• P2-E7 Oxygen Concentrator:
• Sieve Beds:
• Batteries:

Expected Life

• 5 Years
• 2 Years
• 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.
• 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-E7 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-E7 Oxygen 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-E7 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-E7 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.

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
Consult with your doctor periodically to reassess the oxygen delivery settings of this POC 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 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
  The settings of the P2-E7 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-E7.

• WARNING
  There is a risk of fire associated with oxygen equipment and therapy. Do not use near sparks or open flames.

• 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-E7:

• 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 a convertible car with the top down.

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 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-E7 AC and DC power supply
• Use only with P2-E7 batteries
• Use only approved P2-E7 accessories

WARNING
Remove the battery from the device if the P2-E7 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.

Parts Diagram

User Interface Buttons and Display Symbols

Display Panel

Home Screen

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

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”:

Alerts

Adapter plug/unplug
An adapter icon displays when adapter is plugged in and disappears when unplugged. If enabled, an audible alarm will sound.

Battery plug/unplug
A battery icon displays when battery is connected and disappears when disconnected. If enabled, an audible alarm will sound.

Alarm audio selection
An alert will indicate when unit is turned On or Off.

Alarm audio pulse duration
If enabled, an audible alert 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 on next page for additional alarm details.

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

|

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 Contact Provider
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-shutdown after 10 seconds| Battery Cold

Shut down, Move to warmer place

System Hot

| System Temperature

140°F/60°C

| Auto-shutdown after 10 seconds| System Hot

Shut down, Move to cooler place

Battery Hot| Battery Temperature

149°F/65°C

| Auto-shutdown after 10 seconds| Battery Hot

Shut down, Only use adapter

Power Supply Fail| System voltage

<10.5v

| Auto-shutdown after 10 seconds| Power Supply Fail Contact Provider
Gas Supply Fail| Flow or concentration below normal after injection| Auto- shutdown 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

Power Supply

Standard Lithium-lon Battery # P2BY001-2
The P2-E7 is powered by a standard lithium-ion battery. When fully charged the battery can provide up to 6 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-E7 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-E7

DC Power Supply # P2DCA-2
The DC power supply is designed for use with the P2-E7 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.

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 and/or impair equipment performance.

Accessories
Nasal Cannula # P2NC-1
The P2-E7 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 FDA-approved nasal cannula (e.g. P2NC-1)

Carry Bag # P2E7CB
The P2-E7 carry bag allows you to go out for daily activities.

P2-E7 Accessories

General Operation

Find a well ventilated location to place the P2-E7. Ensure that the unit is turned off.
Ensure the Intake and exhaust has clear access. The P2-E7 should be placed where any alarms can be heard.

• WARNING
  Do not use P2-E7 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. 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-E7 Concentrator is designed for continuous use. It is useful to operate the product frequently for optimal sieve bed life.

• CAUTION
  P2-E7 is shipped from factory with battery removed.

Ensure the Pre-Filter Cover is in place.

CAUTION
Do not operate the device without the Cotton Intake Filter and Pre-Filter Cover in place. Operating the device without these in place can damage the device.

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.

Connect AC or DC power to P2-E7.
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. Avoid the use of electrical extension cords with the P2-E7.

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.

• Put the P2-E7 into the carry bag, position vents for exhaust away from user.

Connect the nasal cannula to the nozzle fitting.
Nozzle fitting is located on the top side of the P2-E7 near the Pre-Filter Cover. 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.

Press On/Off button to turn on P2-E7.
The device will beep, and the indicator light will flash.
“Welcome” will appear on the display at start up. The display will indicate the selected flow setting and power condition. 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, such as in extremely cold temperatures where the unit was stored or is being operated.

CAUTION
Oxygen concentration may not reach specification during the two-minute warm up time.

CAUTION
30 seconds after startup, the P2-E7 will enter auto-pulse mode. During these 30 seconds, inhalation will not work.

• Set flow rate prescribed by your provider.

Press the + or – setting buttons to adjust the P2-E7 to the desired flow rate. The current setting can be viewed on the display from 1 to 7.
CAUTION
Ensure the power is in a well-ventilated place. During operation, the power supply may get hot. Ensure the power supply is cool before handling.

• Wear the nasal cannula on your face and breathe through your nose.

The P2-E7 will sense if you are breathing from it. If you are not yet breathing through the cannula, the P2-E7 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 P2-E7 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
If the oxygen level drops below recommended levels, a Low O2: <87% alert will display on the screen. If the alarm persists, contact your provider.

CAUTION
If there is no operation for 30 seconds, the display screen will dim. You can press any button to light up the display.

CAUTION
The P2-E7 will notify you with an audible alert (if enabled) and a display showing “Absence of Breath” if no breath has been detected for 15 seconds. After 15 seconds, the device will enter auto-pulse mode until breath is detected. Once breath is detected, the device will resume normal delivery of oxygen.

Troubleshooting

The table below lists some common problems and solutions. If you can’t resolve a problem, please contact your provider.

Device Won’t Turn On

| 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. If this does not resolve the problem, contact your equipment provider.
AC supply is not connected 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 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 provider to change the sieve beds.
Alarm Occurs| Refer to previous section-Alerts| Refer to previous section- Alerts.

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 or 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 pre-filter coveres.

Cannula Replacement
The nasal cannula is disposable. You can buy replacements from your provider and follow the cannula’s manufacturer’s instructions.

CAUTION
Nasal cannula should be FDA approved and the length should be less than 25ft (7.6m).

Filter Cleaning and Replacement
Filters are designed for adequate air flow through the device at the front of the P2-E7.

Pre-Filter Cover # P2E7PFCR
The Pre-Filter Cover must be cleaned weekly to ensure adequate air flow. Clean with a mild liquid detergent and water. Ensure cover is completely dry before use.

CAUTION
It may be necessary to clean the Pre-Filter Cover more often in dusty or polluted environments/conditions.

Cotton Intake Filter # P2FC-1
The Cotton Intake Filter is designed to ensure clean air enters the compressor.

1. Lift Pre-Filter Cover up by bottom end to remove it.
2.  Remove Cotton Intake Filter from intake chamber.
3. Install a new Cotton Intake Filter into chamber.
4.  Install Pre-Filter Cover.

Pre-Filter Cover and Cotton Intake Filter can be purchased from your provider.
In normal conditions, the air filter must be replaced after approximately 3 months of daily use. When subject to conditions with higher levels of dust or dirt, we recommend periodically checking the air filter. If filter is grey or brown color, replace it. The Cotton Intake Filter cannot be cleaned, it must be replaced.

Battery Care and Maintenance

The P2-E7 Lithium-lon Battery requires special care to ensure proper performance and long life. Only use P2-E7 batteries # P2BY001-2 with your concentrator.

CAUTION
Keep liquids away from the battery. If the battery gets wet, stop using immediately and dispose of battery properly.

Battery Replacement

1. Press down on latch and slide battery out.

2. Insert the P2-E7 battery by sliding battery into place until the latch clicks into place.

Effect of Temperature on Battery Performance
To extend the run-time of your battery, the device should be used in temperatures between 41°F and 95°F (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
Rhythm Healthcare suggests that the room temperature should not exceed 75°F (24°C) when the battery is being charged.

Battery Time Remaining Clock
The P2-E7 continuously displays the 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 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 from the device.

Disposal of Equipment and Accessories

Follow your local governing ordinances for disposal and recycling of the P2-E7 accessories. The battery contains lithium-ion cells and should be recycled and must not be incinerated.

Replacement Items

If you need assistance, please contact your provider.

Specifications

Dimensions| L/W/H 8.70″ × 3.35″ × 6.30″

22.1cm × 8.5cm × 16.0cm

---|---
Weight| 4.37 pounds 1.98Kg (with battery)
User Interface| 2.8’’ LCD color display screen
Sound Level| 39 dB(A) (on setting 2)* 1,2
Time from Turning on the Concentrator to Reach Stated Performance| ****

2 minutes

Oxygen Concentration| 90% – 3% /+ 6% at all settings

Flow Control Settings and Pulse Volumes

| Settings
| 1| 2| 3| 4| 5| 6| 7
Breath Rate| Pulse Volumes(ml)
10| 21| 42| 63| 84| 100| 120| 140
15| 14| 28| 42| 56| 66.7| 80| 93.3
20| 10.5| 21| 31.5| 42| 50| 60| 70
25| 8.4| 16.8| 25.2| 33.6| 40| 48| 56
30| 7| 14| 21| 28| 33.3| 40| 46.7
35| 6| 12| 18| 24| 28.6| 34| 40
40| 5.3| 10.5| 15.8| 21| 25| 30| 35

±15% at STPD* (standard temperature and pressure, dry)

+/-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 Trigger Sensitivity| ****

≤0.12 cm H2O

Time Delay from Onset of Inspiration| < 10ms
Delivery pressure at the device outlet| ****

Maximum 25 PSI

Use Mode| Continuous Use
Available Mode| Triggered pulse delivery mode

1. According to ISO 80601-2-69 the Maximum system sound pressure level of the P2-E7 is 46dB (A) at Setting 2 and 55dB (A) at Setting 5.
2. Data according to test method 14-1 03/2007 MDS-Hi

Power:

AC Power supply DC Power supply

Rechargeable Battery

| AC Input: 100 to 240V | AC 50 to 60 Hz DC Input: 11-16V | DC Output: 19V 6.3A Voltage: 14.4V | DC Rated capacity: 6.7Ah
---|---
**** Battery Duration| Setting 1: 6h

Setting 2: 5.2h

Setting 3: 3.6h

Setting 4: 2.8h

Setting 5: 2.3h

Setting 6: 1.9h

Setting 7: 1.4h

Battery Charging Time| Not more than 4 hours
Environmental Ranges

Intended for Operation

| Temperature: 41˚F to 104˚F (5˚C to 40˚C)

Humidity: 10% – 90%, non-condensing

Altitude: 0 – 10,000 ft. (0 to 3048 meters, 70 kPa to 106 kPa)

Environmental Ranges

Intended for Shipping And Storage

| Temperature: -4˚F to 158˚F (-20˚C to 70˚C)

Humidity: 5% – 90% Non-condensing.

Store in a dry environment

Altitude: 0 – 10,000 ft (0 to 3048 meters, 70 kPa to 106 kPa)

Transportation| Keep Dry. Handle with Care.

Classifications

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 electrical 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: 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, 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/ANSIISO 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
• ISO 14971: 2019, Medical devices — Application of risk management to medical devices

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) IEC61000-4-2

|

±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/ BurstIEC61000-4-4

|

±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 supply should be that of a typical home or hospital environment.

Surge IEC61000-4-5

|

±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.

Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC61000-4-11

|

<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 supply should be that of a typical home or hospital environment.

If the user of the Device required continued operation during power outages,it is recommended that the Device be powered from an uninterruptible power

supply or battery.

Power Frequency (50/60Hz)

Magnetic Field IEC61000-4-8

|

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.
Conducted RF| 3 Vrms| 3 Vrms| Portable and mobile RF communications equipment should not be used closer (to any part of the device, including cables) than the recommended 11.8″ 30 cm separation distance.

Interference may occur in the vicinity of

Equipment marked with the fallowing symbol:

---|---|---|---
IEC 61000-4-6| 150 kHz to 80 MHz| 150 kHz to 80 MHz
Radiated RF| 6 Vrms| 6 Vrms

IEC 61000-4-3

| ****

Amateur Radio &ISM Bands between 150 kHz and 80 MHz

| ****

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 2.7GHz

|

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The P2-E7 is intended for use in the electromagnetic environment specified below. The user of the P2-E7 should ensure it is used in such an environment.

Emission Test| Compliance| Electromagnetic Environment – Guidance
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RF Emissions CISPR 11| Group 1| The P2-E7 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 P2-E7 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 IEC61000-3-2| Class A
Voltage Fluctuations/Flicker Emissions IEC61000-3-3| Complies

Warranty

The P2-E7 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. Excluded from the warranty are damages caused by improper usage. Also excluded are replacements of batteries, disposable parts, and consumables. Sieve bed, filters, batteries are expressly excluded from the 36 months warranty, except as provided below:

Further damage compensation claims of any kind, particularly owing to breach of obligations 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, or the product liability law.

This warranty does not cover damage or injury whether to P2-E7 or to personal property or persons caused by accident, misuse, abuse, negligence, failure to install in accordance with Rhythm’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 materials or workmanship of P2-E7. This warranty does not cover damage which may occur in 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 Rhythm Healthcare or an authorized Rhythm Healthcare service center. This warranty does not apply to any product which is not purchased new.

Rhythm Healthcare
Clearwater, FL 33762
Email: contactus@rhythmhc.com
Website:www.rhythmhc.comV2: 02/02/24

References

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