Celesticare O2C5L TRUAIRE-5 5-Liter Oxygen Concentrator User Manual

Celesticare O2C5L TRUAIRE-5 5-Liter Oxygen Concentrator

INTRODUCTION

INTENDED USE
Thank you for purchasing the TruAire-5 by Roscoe Medical 5-Liter Oxygen Concentrator. It is intended to provide low flow supplemental oxygen therapy to a patient in the home, hospital or a healthcare facility. The device delivers purified oxygen via oxygen mask or nasal cannula by separating nitrogen from room air through a series of internal electronic functions. The patient is the intended operator. Although the device can help to raise blood oxygen levels in a patient, it is not intended to sustain or support life.
CONTRAINDICATIONS
There are no known contraindications.

SAFETY AND PRECAUTIONS

1. DANGER Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
2. WARNING Indicates a potentially hazardous situation that, if not avoided, could result in serious injury or equipment damage.
3. CAUTION Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury to the user or patient or damage to the device or other property.

IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

It is important that you read all warnings in the user’s manual before use. Use the product only for its intended use as described in the manual. Improper use can result in serious or fatal illness / injury, improper treatment or property damage. DO NOT attempt to operate this product without reading all instructions carefully. Save this manual for future reference.

WARNING

U.S. Federal Law restricts these devices to sale by, or on the order of, a physician or licensed practitioner. This device should only be used under the continued supervision of a physician or licensed practitioner.

DANGER

THIS MEDICAL DEVICE IS NOT INTENDED TO BE USED AS A LIFE-SUSTAINING OR LIFE- SUPPORTING DEVICE.

LABELING SYMBOLS AND DESCRIPTIONS

SAFETY PRECAUTIONS AND WARNINGS

WARNING

• Before use, check the ratings label on the back of the device to ensure that the voltage and current indicated on the unit correspond with the voltage and current available. DO NOT overload wall outlets or use with power strips or extension cords.
• DO NOT use this product with a DC to AC converter, or with any AC voltage and/or frequency other than specified.
• NEVER operate this device if it has a damaged cord or plug, is not working properly or any abnormalities occur, or has been exposed to any liquids inside or outside of the housing. Contact your home care provider immediately.
• NEVER allow the power supply cord to be pulled, jerked, strained, twisted, or severely bent, especially at the plug connections. Damage will occur at the high flex point of entry into the appliance, causing it to rupture and short.
• DO NOT open or disassemble the compressor. Contact your home care provider for any service or repair requests.
• DO NOT use the device if it is damaged in any way. Continued use of a damaged device may cause injury to the patient or further damage to the device.
• Keep ALL electrical cords away from heated surfaces. DO NOT operate or store under direct sunlight, high temperature or humidity. See technical specifications for maximum storage and operating temperatures and relative humidity

DISCONTINUE OPERATION IMMEDIATELY IF ANY OF THE MOTOR HOUSING PARTS BECOME DETACHED OR BROKEN, EXPOSING THE MOTOR OR ANY OTHER INTERNAL ELECTRICAL COMPONENTS.

• There is a risk of fire associated with oxygen enrichment during oxygen therapy.
• DO NOT use the oxygen concentrator or accessories near sparks or open flames. DO NOT smoke while the oxygen concentrator is in use.
• Oxygen can make materials flammable. DO NOT leave the nasal cannula or mask on bed coverings, clothing or chair cushions. Turn the oxygen concentrator OFF when not in use.
• Keep the oxygen concentrator away from flammable and explosive areas.
• Patients who require continuous oxygen therapy should plan for alternate sources of power in the event of a power failure. This device is NOT intended to be used as a life sustaining or life supporting device.
• To avoid the risk of fire and burns, NEVER use petroleum or oil-based lotions or salves before or during oxygen therapy.
• DO NOT lubricate fittings, connections, tubing or other accessories of the device to avoid the risk of fire and burns.
• NEVER spray liquids onto the oxygen concentrator housing, especially near the display panel or air vents. Fluid could cause damage to the electrical components and lead to malfunction. If fluid enters the unit, discontinue use immediately and return the product to your home care provider.
• ALWAYS unplug immediately after each use and keep unplugged when not in use. DO NOT run this product unattended.
• This device is to be used ONLY in accordance with the prescription of a physician and this user manual. If at any time the patient or attendant determines insufficient oxygen is being delivered, contact the provider and/or physician immediately.
• DO NOT make adjustments to the flow rate UNLESS prescribed by a physician.
• Close supervision is necessary when this device is used by or near children and physically or mentally impaired persons.
• If the electrical power source becomes unstable, discontinue use immediately and find an alternate power source.
• ONLY use stable and safe electrical power sources.
• NEVER block air openings of the oxygen concentrator or place it where the air openings may be obstructed. Keep the openings free from lint, hair, dust, etc.
• ALWAYS place the oxygen concentrator at least 4 inches away from walls, draperies, furniture, or similar surfaces. ALWAYS avoid deep pile carpets and heaters, radiators or hot air registers.
• NEVER drop or insert any object into any opening.
• DO NOT place the device in a confined area.
• The oxygen concentrator MUST be kept away from heat, fire, and excessive water sources and conditions at ALL times.
• DO NOT place items on top of the oxygen concentrator.
• NEVER use the oxygen concentrator in the presence of pollutants or fumes. The air intake and exhaust should be well-ventilated.
• DO NOT connect the oxygen concentrator in parallel or series with other oxygen concentrators or oxygen therapy devices.
• ALWAYS keep oxygen concentrator at least 10 feet away from wireless communication equipment such as wi-fi network devices, mobile phones, cordless phones and base stations, walkie-talkies, etc.
• DO NOT bring the oxygen concentrator or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the oxygen concentrator or MR medical devices.
• DO NOT use this device or accessories in an environment with electromagnetic equip-ment such as CT scanners, Diathermy, RFID and electromagnetic security systems (metal detectors) as it may cause unacceptable stable risk to the patient or damage to the oxygen concentrator. Some electromagnetic sources may not be apparent; if you notice any unexplained changes in the performance of this device, or it is making unusual sounds, disconnect the power cord and discontinue use immediately. Contact your home care provider.
• This device is suitable for use in home and healthcare environments EXCEPT for near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of electromagnetic disturbances is high.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 1 foot of the oxygen concentra-tor, otherwise degradation of the equipment could result.

DANGER

• Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death. DO NOT allow smoking within the same room or vicinity of the oxygen concentrator, or any oxygen carrying accessories.

• Open flames during oxygen therapy are dangerous and likely to result in fire or death. DO NOT allow open flames within 10 feet of the oxygen concentrator or any oxygen carrying accessories.

• Users MUST NOT smoke while using this device. Keep ALL matches, lighted cigarettes or other sources of ignition out of the room or vicinity of the device. NO SMOKING signs should be prominently displayed. Textiles and other materials may easily ignite and burn with greater intensity in oxygen-enriched air. Failure to observe this warning can result in severe fire, property damage and cause physical injury or death.

• A spontaneous and violent ignition may occur if oil, grease or greasy substances come in contact with oxygen under pressure. These substances MUST be kept away from the oxygen concentrator, tubing and connections, and all other oxygen equipment at ALL times.

• Avoid the creation of any spark near the oxygen concentrator, including static electricity.

• Avoid use while bathing. If continuous usage is required under physician order, the concentrator MUST be in another room at least 10 feet from the bath or shower.

• DO NOT come into contact with the concentrator while wet.

• DO NOT place or store the concentrator where it can drop into water or any
  other liquid.

• DO NOT reach for product that has fallen into water. UNPLUG IMMEDIATELY and contact your home care provider for examination and repair.

• Seek immediate medical assistance in the event of discomfort or a medical emergency while undergoing oxygen therapy.

CAUTION

• Before use, check tubing and accessories for proper assembly. All parts should be firmly in place. Use of improperly assembled tubing and accessories could diminish or prevent adequate delivery of oxygen and the effectiveness of therapy.
• Tubing and accessories are for single patient use only. DO NOT share tubing and accessories with other patients.
• DO NOT modify this device without the authorization of the manufacturer.
• The oxygen concentrator should ALWAYS be kept in an upright position to prevent damage.
• The oxygen concentrator cabinet should ONLY be opened by an authorized repair center.
• DO NOT service or maintain this device while in use.

ILLUSTRATION OF PARTS

TECHNICAL SPECIFICATIONS

Altitude

| Up to 6000’ without degradation of concentration levels

Atmospheric Pressure Range: 12.47 psi-15.37 psi (86 kPa-106 kPa)

Oxygen Concentration| 93% (±3%) at 0.5~5L/min after a warmup period of 30 min.
Maximum Liter Flow| 5L/min
Maximum Outlet Pressure| 5.5 psi ±0.7 psi (35 kPa ± 5 kPa)
Low Flow Alarm| 0.5-5 L/min
Filters| Cabinet, Compressor Inlet, Final Bacteria
Product Dimensions| 13”L x 10.25”W x 21.25”H
Product Weight| 35.5 lbs
Operating Ambient Temperature and Humidity| 41°F-104°F (5°C-40°C),

≤80% RH

Storage and Transport Temperature and Humidity| 32°F-131°F (0°C-55°C)

10%-90% RH

Electrical Classification| Class II equipment, Type BF applied part, IP21
Mode of Operation| Continuous
Minimum Operation Time| 30 minutes

Safety System

| Low-Pressure Alarm

Low Oxygen Concentration Alarm

High Pressure/High-Temperature Shutdown Current Overload/Line Surge Shutdown

Maximum Cannula/Tubing Length| 7’ Cannula + 50’ Oxygen Supply Tubing
Expected Life| 6 Years
Warranty Period| 3 Year Limited, 12,000 Hours on Parts
Software Version| A1.0
Flow Range at Outlet Pressure of 0 psi| 0.5-5L/min
Flow Range at Outlet Pressure of 1 psi| 0.5-5L/min

Change in maximum recommended flow when back pressure of 1 psi is applied

| <0.5L/min

CAUTION: Technical specifications for flowmeter calibration by manufacturer and tester. This device MUST be used according to manufacturer instructions and physician’s order. DO NOT adjust the device flow.

GETTING STARTED

UNPACKING

• Check for any obvious damage to the carton or its contents. If damage is evident, please notify the delivery carrier or your home care provider.
• Remove all loose packing from the carton.
• Carefully remove the oxygen concentrator and all components from the carton.

NOTE: DO NOT dispose of the carton or packing materials. The oxygen concentrator will be required to ship in its original packaging for warranty repair or return.
NOTE: Store the oxygen concentrator in its original packaging until use is required.

PACKING LIST

• Oxygen Concentrator
• Humidifier Bottle
• User Manual

INSPECTION

• Examine exterior of the oxygen concentrator for any visible damage, including nicks, dents, cracks, or scratches.
• Inspect all components, including accessories, display panel, power cord, caster wheels, etc.

STORAGE

• Whenever the oxygen concentrator is not in use, place it back in the original packaging and store in a cool, dry area. DO NOT place anything on top of the repackaged concentrator.

OPERATING THE CONCENTRATOR

SELECT A LOCATION
Select a room in your home where the placement of the oxygen concentrator is most convenient. Take into consideration the Safety Precautions & Warnings detailed on pages 4-6 of this manual. The oxygen concentrator can be rolled from room to room as needed.
SETTING UP THE CONCENTRATOR
Plug the oxygen concentrator power cord to an electrical outlet (see electrical requirements in Technical Specifications)

CONNECT HUMIDIFIER BOTTLE (IF PRESCRIBED)

• Remove cover from humidifier bottle
• Fill a humidifier with purified or boiled (and cooled) tap water. DO NOT fill past the maximum water level line.

WARNING: DO NOT fill humidifier with boiling water

• Tighten the humidifier bottle cover and secure in place by pulling the elastic band at the front of the device and sliding the humidifier bottle down toward the humidifier holder.
• Connect the humidifier to the air outlet using humidifier tubing.
• Connect the nasal cannula or oxygen mask tubing to the air outlet of the humidifier bottle.
• Press the power switch of the oxygen concentrator to the “on” position.
•  After assembly, ensure oxygen flow through cannula or mask.

NOTE: Allow 30 minutes for the device to “warm up” to reach optimum oxygen concentration. A concentrator may be used during the initial warm up time.

FLOWRATE

Turn the flowmeter knob to the setting prescribed by your physician .

NOTE: DO NOT set the flow above the red line on the flow meter. An oxygen flow greater than 5 L/min will decrease the oxygen concentration.
NOTE: If the flow rate on the flowmeter falls below 0.5 L/min, check tubing or accessories for blocked or kinked tubing or a defective humidifier bottle.

O2 SENSOR AND ALARMS

Yellow

| 73%-82%

±2%

| ****

No

| Continue use and call provider immediately. Ensure backup oxygen source is nearby

Yellow

| ****

N/A

| ****

Intermittent

| Compressor failure, low/high pressure or low flow. Call provider immediately.
Red| <73% ±2%| Intermittent| Call provider and switch to backup oxygen source immediately.

TURNING OFF THE CONCENTRATOR
Press power switch to the “off” position and unplug the concentrator from the wall outlet.

MAINTENANCE

With proper care and maintenance, the TruAire-5 Oxygen Concentrator has an expected service life of three years of operation when used in accordance with the safety instructions, maintenance intervals and correct use stated in this manual. The effective service life can vary according to frequency and duration of use. Refer to the Preventive Maintenance Checklist in this manual for a schedule of recommended maintenance.
WARNING: The oxygen concentrator regularly performs a self-check to verify pressure and oxygen concentration. There is no need for calibration of pressure or oxygen concentration. Annual maintenance is recommended for optimal performance and should ONLY be performed by an authorized repair center. DO NOT remove cabinet or attempt to make any repairs.Compass Health Brands recommends use of original parts and filters for optimal performance of the device.
CLEANING THE CABINET
Check the exterior housing of the oxygen concentrator monthly for visible dirt or dust.

• Turn off the power switch and unplug the device.
• Using a damp cloth or sponge with a small amount of mild dish soap, gently clean the exterior case.
•  Allow the surface to air dry or use a clean, dry towel to wipe up dampness before operating the concentrator.

WARNING

DO NOT use acetone, solvents or any other flammable products. DO NOT spill liquid inside the cabinet
DO NOT use lubricants, oils or grease
DO NOT service or maintain while in use
DO NOT spray or apply any cleaning product directly to the cabinet DO NOT hose down the product
CLEANING THE CABINET FILTER

Turn off the power switch and unplug the device.

NOTE: Conditions in the home or facility may require more frequent inspection and cleaning of the filter, including high dust, air pollutants, pet fur and dander, etc.

• Carefully pull the cabinet filter from the side panel.
• Wash the filter in a solution of warm water and mild dish soap.
• Rinse thoroughly with warm tap water and gently squeeze excess water out. Allow to air dry or blow dry completely before reinstalling.

WARNING: DO NOT operate the concentrator without the filters installed, or if filters are wet. Permanent damage to the concentrator could occur.

REPLACING THE INTAKE FILTER

WARNING: The intake filter CAN NOT be cleaned and should only be replaced . NOTE: Intake filter replacement is recommended every 2,000 hours. More frequent inspection and replacement may be required depending on the conditions of the home or facility.

• The intake filter is accessible from the cabinet filter vent panel. Pull the cabinet filter panel from the top tab to access the intake filter behind it.
• Reach inside and remove the intake filter.
• Dispose of the old intake filter and replace with a new intake filter.

CLEANING THE HUMIDIFIER BOTTLE
NOTE: If using a humidifier, change the water daily. Clean the humidifier bottle and cover at least weekly.

• Wash the humidifier bottle and cover with warm water and mild dish soap, then rinse thoroughly with warm running water and dry.
• To disinfect the humidifier bottle and cover, soak in a solution of 1 part vinegar diluted with 10 parts water. Rinse thoroughly with warm running water and dry.

CAUTION: To limit the risk of bacterial growth, clean the humidifier and air dry thoroughly when the concentrator is not in use.

CLEANING AND DISINFECTION BETWEEN PATIENTS

• WARNING: Cleaning and disinfection of the oxygen concentrator and accessories between patients should ONLY be performed by qualified personnel or an authorized repair center.
• Dispose of and replace all single patient accessories including:
  • Nasal Cannula or Oxygen Mask and Supply Tubing
  • Humidifier
  • Filters
• Perform maintenance procedures described in this manual and the Preventive Maintenance Checklist.
• Check the oxygen concentrator for any external damage that may require repair.
• Run checks to ensure the concentrator functions properly and all alarms are in working order.
•  Ensure contents of the package include concentrator and user manual.

PREVENTATIVE MAINTENANCE LOG

Model: Serial Number

EACH INSPECTION

Date of Service|  |  |  |  |  |  |  |  |  |
Hour Meter Readout|  |  |  |  |  |  |  |  |  |
Clean Cabinet Filter|  |  |  |  |  |  |  |  |  |
Liter Flow Prescription|  |  |  |  |  |  |  |  |  |
PREVENTIVE MAINTENANCE/BETWEEN PATIENTS (Every 3 Years or

26,280 Hours)

Oxygen Concentration|  |  |  |  |  |  |  |  |  |
Replace Cabinet Filter|  |  |  |  |  |  |  |  |  |
Replace Intake Filter|  |  |  |  |  |  |  |  |  |
Check Power Loss Alarm|  |  |  |  |  |  |  |  |  |

TROUBLESHOOTING GUIDE

*  Green and Yellow lights on

*  Continuous Alarm

*  Concentrator stops running

*  Hour meter still elapsing time

| 1.   The valve plug is loose

2.   Exhaust sound buffer box jammed

3.   Valve is blocked

4.   Circuit board failure

| ****

Check and connect the valve plug to the circuit board.

2.   Replace part.

3.   Replace part.

4.   Replace part.

| ****

All repairs must be completed by an authorized repair center

• Nasal Cannula is fogging or has water droplets

| 1.   Improper venti- lation is causing elevated operat- ing temperature

2.   Compressor fan is not running or running slow

3.   Water tempera- ture in humidifier is too high

4.   Water exceeds max level in humidifier

| 1.   Ensure device is at least 4 inches from walls, heat- ers, or any other obstructions.

2.   Remove any obstructions blocking the fan, or replace.

3.   Add cold water to the humidifier bottle.

4.   Remove excess water.

| ****

All repairs must be completed by an authorized repair center

• Concentrator is running, but yel- low light is on

| 1.   Oxygen concen- tration is safe but decreasing

2.   Unit is over- heating due to blocked air intake

| 1.   Clean or replace filters.

2.   Ensure device is at least 4 inches from walls, heat- ers or any other obstructions.

| ****

If issue persists, contact home care provider immediately.

*  Concentrator is not running

*  Red light is on

*  Continuous audi- ble alarm sounds

| ****

1.   Low pressure

2.   High pressure

| 1.   Clean or replace filters.

2.   Contact equipment provider immediately.

| If the issue persists, contact home care provider immediately.

*  Concentrator is not running

*  Continuous audi- ble alarm sounds

| ****

1.   Compressor open circuit alarm

2.   Compressor short circuit alarm

| 1.  Contact equipment provider immediately

2.  Contact equipment provider immediately

| ****

All repairs must be completed by an authorized repair center

EMC INFORMATION

Guidance and manufacturer declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS

Guidance and declaration of manufacturer -Electromagnetic emission

The O2C5L Ni Oxygen Concentrator is intended for use in an environment specified below. The customer of the user of JMC5A Ni Oxygen Concentrator should assure that the unit is used in such an environment.
Emission test| Compliance| Electromagnetic environment- regulations

RF emissions CIS- PR 11

| ****

Group 1

| The O2C5L Ni Oxygen Concentrator uses RF energy solely 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 CIS- PR 11

| ****

Class B

| ****

The O2C5L Ni Oxygen Concentrator is suitable for use in all establishments, including domestic and those directly con- nected to the public low- voltage power supply network that supplies building used for domestic purposes.

Emission of harmonics IEC 61000-3-2| ****

Class A

Voltage fluctuations

/ flicker emissions IEC 61000-3-3

| ****

Complies

Guidance and manufacturer’s declaration – electromagnetic immunity

The O2C5L Ni OXYGEN CONCENTRATOR is intended for use in the electromagnetic environment specified below. The customer or the user of O2C5L Ni OXYGEN CONCENTRATOR should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance

Electrostatic dis- charge (ESD) IEC 61000-4-2

| ****

±6 kV contact

±8 kV air

| ****

±6 kV contact

±8 kV air

| Floors should be wood, concrete or ceramic  tile. If floor are covered with synthetic material, the rel- ative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| ****

±2 kV for power supply lines

| ****

±2 kV for power supply lines

| Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

| ±1 kV differen- tial mode

±2 kV common mode

| ±1 kV differential mode

±2 kV common mode

| Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| <5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95% dip in UT) for 5 sec

| <5% UT

(>95% dip in UT) for 0.5 cycle

40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95% dip in UT) for 5 sec

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the O2C5L Ni OXYGEN CONCENTRATOR

requires continued operation during power mains interruptions, it is recommended that the O2C5L Ni OXYGEN CONCENTRATOR be

powered from an uninter- ruptible power supply.

Power frequency (50/60Hz)

magnetic field IEC 61000-4-8

| ****

3A/m

| ****

3A/m

| Mains power quality should be that of a typical commercial or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.

Guidance and manufacturer declaration – electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and declaration of manufacturer – Electromagnetic Immunity For all Equipment and Systems that are not LIFE SUPPORTING

The Oxygen Concentrator is intended for use in the electromagnetic environment specified below. The customer or the user of the Oxygen Concentrator should ensure that the unit is used in such an environment.
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance
 |  |  | Portable and mobile RF communications equip- ment should be used no closer to any part of the OXYGEN CONCENTRATOR, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| ****

3 Vrms

150 kHz to

80 MHz

3 Vrms

80 MHz to

2.5 GHz

| ****

3 Vrms

3 V/m

| ****

Where P the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom- mended separation distance in metres (m).

 |  |  | Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b
 |  |  | Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a.  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts,s and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the OXYGEN CONCENTRATOR is used exceeds the applicable RF compliance level above, the OXYGEN CONCENTRATOR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OXYGEN CONCENTRATOR.

b.   Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Equipment and Systems that are NOT LIFE SUPPORTING

The OXYGEN CONCENTRATOR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OX- YGEN CONCENTRATOR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OXYGEN CONCENTRATOR as recommended below, according to the maximum output power of

Rated maximum output power of transmitter

(W)

| Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz| 80 MHz to 800 mHz

| 800 MHz to 2.5 GHz

0.01| 0.12| 0.12| 0.23
0.1| 0.37| 0.37| 0.74
1| 1.17| 1.17| 2.33
10| 3.69| 3.69| 7.38
100| 11.67| 11.67| 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

LIMITED WARRANTY

Compass Health Brands Corp. warrants the TruAIRE-5 5 Liter Stationary Oxygen Concentrator by Roscoe Medical to be free from defects in workmanship and materials and will perform in accordance with the product specifications for a period of three (3) years from date of shipment to the original dealer who purchased the unit unless contractually specified otherwise. This warranty is limited to exclusions set forth
within this warranty and is also limited to product repair (parts and labor) by Compass Authorized Service Center. Routine maintenance items such as filters and wear component are not covered under this warranty, nor does it cover normal wear and tear. It is at Compass Health’s sole discretion to make the decision on whether to repair or replace a defective unit and Compass Health reserves the right to provide adjustment instructions and/or replacement parts to the dealer or user to perform a repair or adjustment or to replace a defective part. Replacement parts/components are warranted for the unexpired portion of the original Limited Warranty of the unit. This warranty only applies to the labor for repairs performed by the Compass Health Authorized Service Centers. It does not apply to the labor performed by the purchaser or user. The need for a repair under this warranty does not obligate Compass Health to provide a loaner unit during the time that a unit is being shipped to and from an Authorized Service Center and for the time it is being repaired. This Warranty does not cover odors, stains, or fading of colors of the exterior of the unit from exposure to chemicals, heat or light nor does it cover damage associated with spills. This warranty shall be void and Compass Health shall be relieved of any obligation or liability associated if missing:

• Unqualified service personnel attempt to repair the device while under warranty or there has been an attempt to open or service the 4-Way Valve by anyone other than a Compass Health Authorized Service Center.
• The device has been misused, altered, used improperly, or used for any purpose other than what the product was originally designed.
• Malfunction results from inadequate cleaning or failure to follow the use and maintenance instructions.
• Unauthorized parts, components, filters, or regenerated sieve material is utilized in the unauthorized repair of a device.

THIS WARRANTY HAS BEEN DRAFTED TO COMPLY WITH FEDERAL LAW. THERE
IS NO OTHER EXPRESS WARRANTY, IMPLIED WARRANTIES, INCLUDING THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED TO THE DURATION OF THE EXPRESS LIMITED WARRANTY AND TO THE EXTENT PERMITTED BY LAW ANY AND ALL IMPLIED WARRANTIES ARE EXCLUDED.
THIS IS THE EXCLUSIVE REMEDY AND LIABILITY FOR CONSEQUENTIAL AND INCIDENTAL DAMAGES UNDER ANY AND ALL WARRANTIES ARE EXCLUDED TO THE EXTENT EXCLUSION IS PERMITTED BY LAW. COMPASS HEALTH BRANDS CORP DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS, LOSS OF PROFITS, OVERHEAD, CONSEQUENTIAL OR PUNITIVE DAMAGES WHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OF THIS PRODUCT OR TO PRODUCTS DAMAGED
BY CIRCUMSTANCES BEYOND COMPASS HEALTH BRAND CORP’S CONTROL. COMPASS HEALTH BRAND CORP’S SOLE REMEDY TO THE ORIGINAL PURCHASER, IF ANY, IS LIMITED TO THE PRICE PAID FOR THE DEVICE OR PARTS & REPAIRS OF THE DEVICE ISSUE GIVING RISE TO THE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS OR THE LIMITATION OR EXCLUSION OF CONSEQUENTIAL OR INCIDENTAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE.
WARRANTY CLAIM SUBMISSION
The original purchaser must submit any warranty claim to include the serial number of the affected unit directly to Compass Health Brands Corp. Upon verification of the purchaser and warranty status, Compass Health will assign an RMA (Return Merchandise Authorization) for the Dealer along with instructions for the shipping of the affected unit to a Compass Health Authorized Service Center. For all returns, the original purchaser must:

1. Properly package the unit in the original, TruAIRE-5 approved shipping carton
2. Properly display the Return Authorization Number on the shipping carton
3. Send the shipment to the designated Authorized Repair Center freight prepaid

When the device is repaired and tested it will be returned to the original purchaser to an address within the 48 continental United States via the most economical means and at the expense of Compass Health Brands Corp. If expedited repair and/or alternate or expedited return shipping is desired by the original purchaser, the coordination of and incremental expense for the expedited repair and shipping will be the complete responsibility of the original purchaser.

Manufactured for
Compass Health Brands Corp. 6753 Engle Rd.
Middleburg Heights, OH 44130 www.compasshealthbrands.com Phone: 800.376.7263
Made in China
42-O2C5L_00 ©2021

References

• Home Medical Products For Seniors, Elderly, Surgery Patients

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