AirSep New Life Intensity Stationary Oxygen Concentrator USER MANUAL User Manual

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NewLife® Family

User Manual (English)

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NewLife Family

User Controls & System Status Indicators

ISO 7000; Graphical symbols for use on equipment—Index and synopsis

Read user’s manual before operation. Reg. # 1641

Storage or operating temperature range. Reg. # 0632

Storage humidity range. Reg. # 2620

Atmospheric pressure limitation. Reg. # 2621

Keep away from rain, keep dry. Reg. # 0626

Name and address of manufacturer. Reg. # 3082

Caution, consult accompanying documents. Reg. # 0434A

Catalog Number. Reg. # 2493

Serial Number. Reg. # 2498

This way up. Reg. # 0623

Fragile, handle with care. Reg. # 0621

Stacking limit by number. Reg. # 2403

ISO 7010: Graphical symbols—Safety colors and safety signs—Registered safety signs

The instruction manual must be read. Reg. # M002

Keep away from open ame, re,

sparks. Open ignition source and smoking prohibited. Reg. # P003

Do not smoke near unit or while operating unit. Reg. # P002

Type BF applied part (degree of protection against electric shock). Reg. # 5333

Council Directive 93/42/EEC; concerning medical devices

Authorized representative in the European Community

If the product unique device identier

(UDI) label has the CE#### symbol on it, the device complies with the requirements of Directive 93/42/EEC concerning medical devices. The

CE#### symbol indicates notied

body number.

Internal Symbols

Keep away from ammable materials,

oil and grease.

Safety agency for CAN/CSA C22.2 No. 60601-1-14 for medical

electrical equipment. Certied for

both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.

Do not disassemble.

When present on the device alarm panel indicates external power interruption has been detected.

When present on the device alarm panel indicates low oxygen concentration in device output.

ON (power switch on)

OFF (power switch off)

Date of Manufacture

Class II equipment

21 CFR 801.15: Code of Federal Regulations Title 21

Federal law restricts this device to sale by or on the order of a physician.

Warning. Reg. # W001

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NewLife Family

IEC 60601-1: Medical electrical equipment Part 1 General requirements for basic safety and essential performance

Drip Proof Equipment - IP21

Council Directive 2012/19/EU: waste electrical and electronic equipment (WEEE)

WEEE This symbol is to remind the equipment owners to return it to a recycling facility at the end of its life, per Waste Electrical and Electronic Equipment (WEEE) Directive. Our products will comply with the restriction of Hazardous Substances (RoHS) directive. They will not contain more than trace amounts of lead or other hazardous material content.

This product may be covered by one or more patents, US and international. Please visit our website below for the listing of applicable patents. Pat.: www.caireinc.com/corporate/patents/.

NewLife® Oxygen Concentrator

This User Manual will acquaint you with the NewLife Oxygen Concentrator (5-liter and 10-liter models). Make sure you read and understand all the information contained in this manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.

What is the Oxygen Concentrator

The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gasses. In the NewLife oxygen concentrator, room air is drawn into the machine through the air intakes. It then passes through an adsorbent material called molecular sieve. This material separates the oxygen from the nitrogen and allows only the oxygen to pass

through. The result is a ow of high-concentration

oxygen delivered to the user.

Note: There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit.

Why Your Physician Prescribed Oxygen

Many people suffer from a variety of heart, lung,

and other respiratory diseases. A signicant number of these people can benet from supplemental

oxygen therapy at home, when traveling, or while participating in daily activities away from home.

Oxygen is a gas that makes up 21% of the room air we breathe. Our bodies depend on a steady supply to function properly. Your physician prescribed a

ow or setting to address your particular respiratory

condition.

Although oxygen is a non-addictive drug, unauthorized oxygen therapy can be dangerous. You must seek medical advice before you use this oxygen concentrator. The Equipment Provider who supplies your oxygen equipment will demonstrate how to set

the prescribed ow rate.

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NewLife Family

WARNING: “NO SMOKING – OXYGEN IN USE” SIGNS MUST BE PROMINENTLY DISPLAYED IN THE HOME, OR WHERE OXYGEN IS IN USE. USERS AND THEIR CAREGIVERS MUST BE INFORMED ABOUT THE DANGERS OF SMOKING IN THE PRESENCE OF, OR WHILE USING, MEDICAL OXYGEN.

WARNING: IN THE EVENT THERE IS A SERIOUS INCIDENT OCCURRING WITH THIS DEVICE, THE USER SHOULD IMMEDIATELY REPORT THE INCIDENT TO THE PROVIDER AND/OR THE MANUFACTURER. A SERIOUS INCIDENT IS DEFINED AS AN INJURY, DEATH, OR POTENTIAL TO CAUSE INJURY/DEATH SHOULD THERE BE A REOCCURRENCE OF THE INCIDENT. THE USER CAN ALSO REPORT THE INCIDENT TO THE COMPETENT AUTHORITY IN THE COUNTRY WHERE THE INCIDENT OCCURRED.

CAUTION: The Manufacturer recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure. Consult your physician or Equipment Provider for the type of reserve system required.

It is very important to select only the prescribed level of oxygen. Do not change the ﬂow selection unless you have been directed to do so by a licensed clinician.

The Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician.

variety of respiratory diseases, including Chronic Obstructive Pulmonary Disorder (COPD). Users typically have good cognitive abilities and must be able to communicate discomfort. If the user is unable to communicate discomfort, or unable to read and understand the concentrator labeling and instructions for use, then use is recommended only under the supervision of one who can. If any discomfort is felt while using the concentrator, users are advised to contact their healthcare provider. Users are also advised to have back-up oxygen available (i.e. cylinder oxygen) in the event of a power outage or concentrator failure. There are no other unique skills or user abilities required for concentrator use.

Unpacking Your NewLife

Verify that all of the components listed and shown below are included in the package. If any items are missing, contact your oxygen provider immediately.

• Stationary Oxygen Concentrator

Operator Proﬁle

Concentrators are intended to supply supplemental oxygen to users suffering from discomfort due to

ailments which effect the efciency of one’s lungs

to transfer oxygen in the air to their bloodstream. Stationary oxygen concentrators (SOCs) do not store or contain oxygen. They do not need to be

relled, and can operate at any location where AC

power source is available. Oxygen concentrator use requires a physician’s prescription and is not intended for life support use.

Although oxygen therapy can be prescribed for users of all ages, the typical oxygen therapy user is older than 65 years of age and suffers from a

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Getting to Know Your NewLife Oxygen Concentrator

First, become familiar with the important parts of your NewLife Oxygen Concentrator (Figures 1a, 1b).

A. On/Off (I/0) Power Switch: Starts and stops the

operation of the unit.

B. Circuit Breaker Reset Button: Resets the unit

after electrical overload shutdown

C. Digital Hour Meter: Records the unit’s total

hours of operation.

D. Flowmeter/Adjustment Knob: Controls and

indicates the oxygen ow rate in liters per minute

(lpm).

E. Oxygen Outlet: Provides connections for a

humidier (if required), nasal cannula, face mask,

or catheter.

F. Top and Side Handles: Enables convenience in

carrying the unit.

G. Operating Instructions: Explains procedures to

operate the unit.

H. Air Intake Gross Particle Filter: Prevents dust

and other airborne particles from entering the unit.

I. Power Cord: Allows connection of unit into

electrical outlet.

Figure 1a

WARNING: DO NOT USE EXTENSION CORDS WITH THIS UNIT OR CONNECT TOO MANY PLUGS INTO THE SAME ELECTRICAL OUTLET. THE USE OF EXTENSION CORDS COULD ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE. TOO MANY PLUGS INTO ONE OUTLET CAN RESULT IN AN OVERLOAD TO THE ELECTRICAL PANEL CAUSING THE BREAKER/FUSE TO ACTIVATE OR FIRE IF THE BREAKER OR FUSE FAILS TO OPERATE.

Important!

Safety Instructions are deﬁned as follows:

WARNING: IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT CAUSE SERIOUS INJURY.

CAUTION: Important information for preventing damage to the NewLife Family.

Note: Information needing special attention.

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Figure 1b

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Indications for Use

Intended Use

The CAIRE NewLife Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

WARNING: IT IS VERY IMPORTANT TO SELECT ONLY THE PRESCRIBED LEVEL OF OXYGEN. DO NOT CHANGE THE FLOW SELECTION UNLESS YOU HAVE BEEN DIRECTED TO DO SO BY A LICENSED CLINICIAN.

WARNING: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE OR RENTAL BY ORDER OF A PHYSICIAN OR OTHER LICENSED HEALTH CARE PROVIDER.

WARNING: THIS UNIT IS NOT TO BE USED FOR LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR ANY OTHER USER UNABLE TO COMMUNICATE DISCOMFORT WHILE USING THIS DEVICE MAY REQUIRE ADDITIONAL MONITORING. USERS WITH HEARING AND/OR SIGHT IMPAIRMENT(S) MAY NEED ASSISTANCE WITH MONITORING ALARMS. IF YOU FEEL DISCOMFORT OR ARE EXPERIENCING A MEDICAL EMERGENCY, SEEK MEDICAL ASSISTANCE IMMEDIATELY.

Contraindications for Use

WARNING: IN CERTAIN CIRCUMSTANCES, THE USE OF NON-PRESCRIBED OXYGEN CAN BE HAZARDOUS. THIS DEVICE SHOULD ONLY BE USED WHEN PRESCRIBED BY A PHYSICIAN.

WARNING: NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

WARNING: AS WITH ANY ELECTRICALLY POWERED DEVICE, THE USER MAY EXPERIENCE PERIODS OF NON-OPERATION AS A RESULT OF ELECTRICAL POWER INTERRUPTION, OR THE NEED TO HAVE THE OXYGEN CONCENTRATOR SERVICED BY A QUALIFIED TECHNICIAN. THE OXYGEN CONCENTRATOR IS NOT APPROPRIATE FOR ANY USER WHO WOULD EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE RESULT OF SUCH TEMPORARY INTERRUPTION.

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Safety Guidelines

WARNING: CAREFULLY REVIEW AND FAMILIARIZE YOURSELF WITH THE FOLLOWING IMPORTANT SAFETY INFORMATION ABOUT THE NEWLIFE INTENSITY OXYGEN CONCENTRATOR.

WARNING: DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS, CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTING TO USE THIS EQUIPMENT; OTHERWISE INJURY OR DAMAGE COULD OCCUR.

WARNING: SMOKING WHILE USING OXYGEN IS THE NUMBER ONE CAUSE OF FIRE INJURIES AND RELATED DEATHS. YOU MUST FOLLOW THESE SAFETY WARNINGS:

WARNING: DO NOT ALLOW SMOKING, CANDLES, OR OPEN FLAMES IN THE SAME ROOM WITH THE DEVICE OR THE OXYGEN-CARRYING ACCESSORIES.

WARNING: SMOKING WHILE WEARING AN OXYGEN CANNULA CAN CAUSE FACIAL BURNS AND POSSIBLY RESULT IN DEATH.

WARNING: REMOVING THE CANNULA AND PLACING IT ON CLOTHING, BEDDING, SOFAS, OR OTHER CUSHION MATERIAL WILL CAUSE A FLASH FIRE WHEN EXPOSED TO A CIGARETTE, HEAT SOURCE, SPARK OR OPEN FLAME.

WARNING: IF YOU SMOKE, YOU MUST ALWAYS FOLLOW THESE THREE (3) IMPORTANT STEPS FIRST: TURN OFF THE OXYGEN CONCENTRATOR, TAKE OFF THE CANNULA, AND LEAVE THE ROOM WHERE THIS DEVICE IS LOCATED.

WARNING: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE OR RENTAL BY ORDER OF A PHYSICIAN OR OTHER LICENSED HEALTH CARE PROVIDER.

WARNING: THIS DEVICE SUPPLIES HIGH-CONCENTRATION OXYGEN THAT PROMOTES RAPID BURNING. DO NOT ALLOW SMOKING OR OPEN FLAMES WITHIN THE SAME ROOM OF (1) THIS DEVICE, OR (2) ANY OXYGEN-CARRYING ACCESSORY. FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE, PROPERTY DAMAGE AND / OR CAUSE PHYSICAL INJURY OR DEATH.

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NewLife Family

WARNING: DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE GASES. THIS CAN RESULT IN RAPID BURNING CAUSING PROPERTY DAMAGE, BODILY INJURIES OR DEATH.

WARNING: DO NOT LEAVE A NASAL CANNULA ON CLOTHING, BED COVERINGS OR CHAIR CUSHIONS. IF THE UNIT IS TURNED ON BUT NOT IN USE, THE OXYGEN WILL MAKE THE MATERIAL FLAMMABLE. SET THE I/0 POWER SWITCH TO THE 0 (OFF) POSITION WHEN THE OXYGEN CONCENTRATOR IS NOT IN USE.

WARNING: USE NO OIL, GREASE, OR PETROLEUM-BASED OR OTHER FLAMMABLE PRODUCTS WITH THE OXYGEN-CARRYING ACCESSORIES OR THE OXYGEN CONCENTRATOR. OXYGEN ACCELERATES THE COMBUSTION OF FLAMMABLE SUBSTANCES.

WARNING: USE ONLY WATER-BASED LOTIONS OR SALVES THAT ARE OXYGEN COMPATIBLE PRIOR TO OR DURING OXYGEN THERAPY. NEVER USE PETROLEUM OR OIL-BASED LOTIONS OR SALVES TO AVOID THE RISK OF FIRE OR BURNS.

WARNING: DO NOT LUBRICATE FITTINGS, CONNECTIONS, TUBING, OR OTHER ACCESSORIES OF THE OXYGEN CONCENTRATOR TO AVOID THE RISK OF FIRE AND BURNS.

WARNING: ELECTRICAL SHOCK HAZARD. TURN OFF THE UNIT AND DISCONNECT THE POWER CORD FROM THE ELECTRIC OUTLET BEFORE YOU CLEAN THE UNIT TO PREVENT ACCIDENTAL ELECTRICAL SHOCK AND BURN HAZARD. ONLY YOUR EQUIPMENT PROVIDER OR A QUALIFIED SERVICE TECHNICIAN SHOULD REMOVE THE COVERS OR SERVICE THE UNIT.

WARNING: CARE SHOULD BE TAKEN TO PREVENT THE OXYGEN CONCENTRATOR FROM GETTING WET OR ALLOWING FLUIDS TO ENTER THE UNIT. THIS CAN CAUSE THE UNIT TO MALFUNCTION OR SHUT DOWN, AND CAUSE AN INCREASED RISK FOR ELECTRICAL SHOCK OR BURNS.

, LESTOIL®). THESE ARE NOT TO BE USED TO CLEAN THE PLASTIC HOUSING ON THE OXYGEN CONCENTRATOR, AS THEY CAN DAMAGE THE UNIT’S PLASTIC.

WARNING: CLEAN THE CABINET, CONTROL PANEL, AND POWER CORD ONLY WITH A MILD HOUSEHOLD CLEANER APPLIED WITH A DAMP CLOTH (NOT WET) OR SPONGE, AND THEN WIPE ALL SURFACES DRY. DO NOT ALLOW ANY LIQUID TO GET INSIDE THE DEVICE.

WARNING: THE OXYGEN CONCENTRATOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS UNAVOIDABLE, THE DEVICE SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION.

WARNING: ALWAYS PLACE THE OXYGEN SUPPLY TUBING AND POWER CORDS IN A MANNER THAT PREVENTS TRIP HAZARD OR POSSIBLE ACCIDENTAL STRANGULATION.

WARNING: NO MODIFICATION OF THIS EQUIPMENT IS PERMITTED.

WARNING: USE OF CABLES AND ADAPTERS OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF CABLES AND ADAPTERS SOLD BY THE MANUFACTURER OF THE MEDICAL ELECTRICAL EQUIPMENT AS REPLACEMENT PARTS FOR INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OF DECREASED IMMUNITY OF THE OXYGEN CONCENTRATOR.

WARNING: USE ONLY ELECTRICAL VOLTAGE AS SPECIFIED ON THE SPECIFICATION LABEL AFFIXED TO THE DEVICE.

WARNING: ENVIRONMENTAL CONDITIONS CAN AFFECT PERFORMANCE OF DEVICE. LOCATE IN CLEAN, PEST-FREE ENVIRONMENT.

WARNING: DEVICE SHOULD ONLY BE OPERATED BY END USERS, TRAINED CAREGIVERS, OR TRAINED TECHNICIANS. CHILDREN SHOULD NOT OPERATE THE DEVICE.

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NewLife Family

WARNING: USE OF DEVICE OUTSIDE OF SPECIFIED OPERATING CONDITIONS IS EXPECTED TO ADVERSELY AFFECT THE FLOWRATE AND PERCENTAGE OF OXYGEN AND CONSEQUENTLY THE QUALITY OF THE THERAPY.

WARNING: THE USE OF SOME OXYGEN ADMINISTRATION ACCESSORIES NOT SPECIFIED FOR USE WITH THIS OXYGEN CONCENTRATOR MAY IMPAIR ITS PERFORMANCE. RECOMMENDED ACCESSORIES ARE REFERENCED WITHIN THIS MANUAL.

WARNING: TO ENSURE RECEIVING THE THERAPEUTIC AMOUNT OF OXYGEN DELIVERY ACCORDING TO YOUR MEDICAL CONDITION THE NEWLIFE UNIT MUST BE USED WITH THE SPECIFIC COMBINATION OF PARTS AND ACCESSORIES THAT ARE IN LINE WITH THE SPECIFICATION OF THE CONCENTRATOR MANUFACTURER AND THAT WERE USED WHILE YOUR SETTINGS WERE DETERMINED.

CAUTION: Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider.

CAUTION: Do not position the unit so that it is difﬁcult to access the power cord.

CAUTION: The concentrator should be located as to avoid smoke, pollutants or fumes.

CAUTION: Ensure concentrator is operated in an upright position.

CAUTION: Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard.

CAUTION: If the audio alarm is weak or does not sound at all, consult your Equipment Provider immediately.

CAUTION: It is very important to select only the prescribed level of oxygen. Do not change the ﬂow selection unless you have been directed to do so by a licensed clinician.

CAUTION: The Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician. CAUTION: Do not operate this unit in a restricted or conﬁned space where ventilation can be limited. This can cause the device to overheat and affect performance.

CAUTION: Do not allow either the air intake or the air outlet vents to be blocked. DO NOT drop or insert any object into any openings on the device. This can cause the Oxygen Concentrator to overheat and impair performance.

CAUTION: Operating or storing the Oxygen Concentrator outside of its normal operating temperature range can impair the performance of the unit. Refer to the speciﬁcation section of this manual for storage and operating temperature limits.

CAUTION: Position the unit away from curtains or drapes, hot air registers or heaters. Be certain to place the unit on a ﬂat surface and make sure all sides are at least 1 foot (30 cm) away from a wall or other obstruction. Do not place the unit in a conﬁned area. Choose a dust and smoke free-location away from direct sunlight. Do not operate the unit outdoors unless the unit is plugged into a Ground Fault Circuit Interrupter (GFCI) protected outlet.

CAUTION: In the event of an alarm or you observe the Oxygen Concentrator is not working properly; consult the troubleshooting section of this manual. If you cannot resolve the problem, consult your Equipment Provider.

CAUTION: If the humidiﬁer bottle tubing is not properly connected to the humidiﬁer bottle ﬁtting or to the oxygen outlet, an oxygen leak can occur.

CAUTION: Normally, you should not need to adjust the ﬂowmeter on your unit. If you turn the ﬂowmeter adjustment knob clockwise, you will decrease and can shut off the ﬂow of oxygen from your unit. For your convenience, the ﬂowmeter is marked in ½ LPM increments. For units equipped with the 2 LPM ﬂowmeter option, the ﬂowmeter is marked in 1/8 LPM increments for ﬂow settings up to 2 LPM.

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Note: . Ensure the cannula is fully inserted and secure. You should hear or feel oxygen ﬂow to the prongs of the nasal cannula. If oxygen does not seem to ﬂow, ﬁrst verify that the ﬂow meter ball is registering a ﬂow. Then, place the tip of the cannula into a glass of water; if bubbles come out of the cannula, oxygen is ﬂowing. If bubbles do not appear, refer to the troubleshooting section of this manual.

Note: Always follow the cannula manufacturer’s instructions for proper use. Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider. Additional supplies are available from your Equipment Provider.

Note: Allow the unit to run for at least 5 minutes at 2 LPM or above before use.

Note: Always follow the cannula manufacturer’s instructions for proper use. Replace the disposable cannula as recommended by the cannula manufacturer or your equipment provider. Additional supplies are available from your equipment provider.

Note: The Manufacturer does not recommend the sterilization of this equipment.

Note: If the unit has not been used for an extended period of time, it needs to operate for several minutes before power failure alarm can become activated.

Note: The concentrator releases warm air out the bottom of the unit which can permanently discolor temperature sensitive ﬂooring surfaces such as vinyl. The concentrator should not be used over ﬂooring that is sensitive to heat staining. The Manufacturer is not responsible for ﬂooring that becomes discolored.

Note: The NewLife Intensity Oxygen Concentrator must be operated for at least ﬁve minutes at 2 LPM before using the unit.

The NewLife Intensity is appropriate for usage by two users, provided the combined ﬂow is a minimum of 2 LPM and does not exceed the maximum capacity of the concentrator.

Note: The standard NewLife Elite Oxygen Concentrator accommodates prescriptions from 1 LPM minimum to 5 LPM maximum.

Note: The standard NewLife Intensity 10 Oxygen Concentrator accommodates prescriptions from 2 LPM to 10 LPM maximum.

Note: To prevent a void warranty, follow all manufacturers’ instructions.

Note: Do not attempt any maintenance other than the possible solutions listed within the manual.

Note: Do not operate the unit without the intake gross particle ﬁlter in place.

Note: Portable and mobile radio frequency (RF) communications equipment can effect medical electrical equipment.

Note: There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit.

Note: To Equipment Provider: The following oxygen administration accessories are recommended for use with the NewLife:

• Nasal Cannula: CAIRE Part Number CU002-1

• Humidiﬁer Adaptor Tubing: CAIRE Part Number 20843882

• Humidiﬁer Bottle: CAIRE Part Number HU003-1

• Firebreak: CAIRE Part Number 20629671

A ﬁrebreak is required for use with any cannula.

• CAIRE offers a ﬁrebreak intended to be used in conjunction with the oxygen concentrator. The ﬁrebreak is a thermal fuse to stop the ﬂow of gas in the event that the downstream cannula or oxygen tubing is ignited and burns to the ﬁrebreak. It is placed in-line with the nasal cannula or oxygen tubing between the patient and the oxygen outlet of the NewLife. For proper use of the ﬁrebreak, always refer to the manufacturer’s instructions (included with each ﬁrebreak kit).

• For any additional recommended accessories, please see the Accessories Catalog (PN MLLOX0010) available on www.caireinc.com.

WARNING: KEEP OUT OF THE REACH OF CHILDREN UNTIL INSTALLED.

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING NICKEL, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER. FOR MORE INFORMATION, GO TO WWW.P65WARNINGS.CA.GOV.

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Speciﬁcations

NewLife Elite NewLife Intensity 10

Flow Rates* 1–5 LPM

±10% of indicated setting, or 200 mL, whichever is greater**

Dimensions 28.5 x 15.7 x 14.5 in

Weight 54 lbs (24.5 kg) 58 lbs (26.3 kg)

Sound Pressure Level

Power Consumption

O2 Concentration 90% +5.5 -3 90% +5.5 -3

Output Pressure 7.3-8.8 psi (50.3-60.7 kPA) 20 psig (138 kPA)

Operating Environment*

Altitude -1250 to 10,000 ft (-381 to 3048 m)

Storage Environment

Warranty 3 Years 3 Years

Maintenance Schedule

Max Tubing 50 ft (15.2 m) 200 ft (61 m)

(72.4 x 40.0 x 36.8 cm)

53 dB(A) at ﬂow rates of 1 to 5 LPM 58 dB(A) at ﬂow rates of 2 to 10 LPM

350 watts–1-5 lpm model Two-prong polarized plug Double insulated cabinet North American Models: 120 VAC, 60 Hz, 4.0 amps Export Models: 230 VAC, 50 Hz, 2.0 amps 230 VAC, 60 Hz, 2.0 amps

41° to 104°F (5° to 40°C) 15–90% Humidity

(tested to 700 – 1060 hPa)

-25° C to 70° C (-13° F to 158° F), 0–90% Humidity (non-condensing)

Felt Filter (230 V only) – 1 Year Replacement Intake Filter – Clean Weekly

2–10 LPM

±10% of indicated setting, or 200 mL, whichever is greater**

27.5 x 16.5 x 14.5 in (69.9 x 41.9 x 36.8 cm)

600 watts–2-10 LPM model Two-prong polarized plug Double insulated cabinet North American Models: 120 VAC, 60 Hz, 6.0 amps Export Models: 230 VAC, 50 Hz, 3.0 amps

41°F to 104°F (5°C to 40°C), 15–90% humidity

-1250 to 10,000 ft (-381 to 3048 m) (tested to 700 – 1060 hPa)

-25° C to 70° C (-13° F to 158° F), 0-90% Humidity (non-condensing)

Felt Filter – 1 Year Replacement, Intake Filter – Clean Weekly

* Based on an atmospheric pressure range of 700 hPa to 1060 hPa at 70°F (21°C)

** At altitudes below sea level and higher than 8,000 ft (2438 m) above sea level, ow meter accuracy may be affected

up to 13%.

The expected service life of this device is a minimum of ve years.

See technical manual (PN MN240-1) for sound power level.

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Operating Instructions

NewLife Family

1. Locate the unit near an electrical outlet in the room where you spend most of your time.

2. Position the unit away from curtains or drapes,

hot air registers, heaters, and replaces. Be

certain to place the unit so all sides are at least 12 inches (30.5 cm) away from a wall or other

obstruction. Do not place the unit in a conned

area.

3. Turn the unit so that the operating controls are within easy reach and the air intake on the back of the unit is not obstructed.

4. Connect oxygen accessories such as a humidier

(if required), nasal cannula, face mask, catheter, and/or extension tubing to the oxygen outlet.

5. Completely unwrap the power cord.

6. Insert power cord into the electrical outlet.

7. Locate the power switch on the front of the unit, and switch it to the | position (on).

An audible and visual alarm must sound for a

short test to indicate proper alarm function.

Note: The standard NewLife Intensity Oxygen Concentrator accommodates high pressure/high ﬂow prescriptions.

Note: The standard NewLife Elite Oxygen Concentrator accommodates prescriptions from 1 LPM minimum to 5 LPM maximum.

Note: The standard NewLife Intensity 10 Oxygen Concentrator accommodates prescriptions from 2 LPM to 10 LPM maximum.

8. Set the owmeter adjustment knob to the

prescribed LPM. The concentrator is now ready for use.

Elite (left) and Intensity (right)

9. To turn the concentrator off, press the I/0 switch to the 0 position.

10. If the NewLife unit fails to operate properly, refer to the Troubleshooting section for a list of probable causes and solutions.

CAUTION: If the alarm is weak or does not sound at all, consult your Equipment Provider immediately.

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NewLife Family

WARNING: DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE GASES. THIS CAN RESULT IN RAPID BURNING CAUSING PROPERTY DAMAGE, BODILY INJURIES OR DEATH.

WARNING: USE NO OIL, GREASE, OR PETROLEUM-BASED OR OTHER FLAMMABLE PRODUCTS WITH THE OXYGEN-CARRYING ACCESSORIES OR THE OXYGEN CONCENTRATOR. ONLY WATER BASED, OXYGEN COMPATIBLE LOTIONS OR SALVES SHOULD BE USED. OXYGEN ACCELERATES THE COMBUSTION OF FLAMMABLE SUBSTANCES.

WARNING: THE USE OF SOME OXYGEN ADMINISTRATION ACCESSORIES NOT SPECIFIED FOR USE WITH THIS OXYGEN CONCENTRATOR MAY IMPAIR ITS PERFORMANCE. RECOMMENDED ACCESSORIES ARE REFERENCED WITHIN THIS MANUAL

CAUTION: Always operate the unit in an upright position.

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Proper Setting of Oxygen Flowmeter

To set the proper ow of supplemental oxygen, turn the owmeter adjustment knob left or right until the ball inside the owmeter centers on the ow line

number prescribed by your physician.

To view the owmeter at the proper angle, note that

Elite (top) and Intensity (bottom)

the back line and the front numbered line must give the appearance of just one line.

CAUTION: It is very important to select only the prescribed level of oxygen. Do not change the ﬂow selection unless you have been directed to do so by a licensed clinician.

Normally, you should not need to adjust the ﬂowmeter on your unit. If you turn the ﬂowmeter adjustment knob clockwise, you will decrease and can shut off the ﬂow of oxygen from your unit. For your convenience, the ﬂowmeter is marked in ½ LPM increments. For units equipped with the 2 LPM ﬂowmeter option, the ﬂowmeter is marked in 1/8 LPM increments for ﬂow settings up to 2 LPM.

The Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician.

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Filters

Air enters the NewLife unit through an air intake

gross particle lter located on the back off the oxygen concentrator. This lter removes dust particles

and other large particles from the air. Before you

operate the NewLife unit, make sure this lter is

clean and positioned correctly.

The supplemental oxygen produced by the NewLife

unit receives additional ltration from a product lter (for particle size 10 micron or greater) located

within the oxygen concentrator. Your equipment

Provider performs maintenance on the product lter

in addition to other maintenance on the unit.

NewLife Family

Operating With Humidiﬁer

Following these steps if your physician prescribed

an oxygen humidier as part of your therapy:

1. Remove or unscrew the reservoir bottle from the

humidier (If you have a pre-lled unit do not

perform this step. Proceed directly to step 4.)

2. Fill the reservoir with cool or cold water (dis-

tilled water is preferred) to the ll line indicated

on the bottle. DO NOT OVERFILL.

3. Screw the reservoir bottle back together.

Operating Without Humidiﬁer

1. If your physician did not prescribe a humidi-

er, connect the oxygen tubing directly to the unit’s oxygen outlet. A separate outlet tting is

supplied for this type of connection.

4. On the top of the humidier, turn the thread nut

counterclockwise while you connect the humidi-

er to the oxygen outlet, and tighten securely.

5. Connect oxygen tubing from the nasal cannula,

face mask, or other accessories to the humidier outlet tting.

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Page 14

NewLife Family

Note: The use of some oxygen administration accessories not speciﬁed for use with this oxygen concentrator may impair its performance. Recommended accessories are reference within this manual.

Note: To Equipment Provider: The following humidiﬁer bottles are recommended for use with the NewLife Oxygen Concentrators: Part No. HU003-1 (recommended for Elite models) Part No. HU014-1 (recommended for Intensity models)

Nasal Cannula

Your physician has prescribed either a nasal cannula, face mask, or other accessories. In most cases the manufacturer has already connected the oxygen supply tubing to the nasal cannula, face mask, or other accessory.

Note: To Equipment Provider: The following oxygen administration accessories are recommended for use with the NewLife Oxygen Concentrator:

• Nasal Cannula with 7 feet (2.1 m) of tubing (6 LPM max): Part No. CU002-1

• Oxygen Outlet Adapter (6 LPM max) (Not for use with Intensity 10 LPM): Part No. F0025-1

• Face Mask with 7 feet (2.1 m) of tubing (10 LPM Max)*: Part No. MS013-1

• Humidiﬁer Adapter Extension: Part No. HU002-1

• Humidiﬁer Bottle for Elite models: Part No. HU003-1

• Humidiﬁer Bottle for Intensity models: Part No. HU014-1

*Face mask should only be used with Intensity 10 models.

Note: Ensure the cannula is fully inserted and secure. You should hear or feel oxygen ﬂow to the prongs of the nasal cannula. If oxygen does not seem to ﬂow, ﬁrst verify that the ﬂowmeter ball is registering a ﬂow. Then, place the tip of the cannula into a glass of water; if bubbles come out of the cannula, oxygen is ﬂowing. If bubbles do not appear, refer to the troubleshooting section of this manual.

Always follow the cannula manufacturer’s instructions for proper use. Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider. Additional supplies are available from your Equipment Provider.

If not, follow the manufacturer’s instructions for proper connection. Connect the oxygen tubing to

the oxygen outlet adapter or humidier.

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Page 15

Safety Features

The following information will acquaint you with safety features of the NewLife Oxygen Concentrator. Make sure you read and understand all the information contained in this manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.

• Compressor Motor: A pressure

relief valve is tted to the

compressor outlet and is calibrated to 360 kPa (52 psig). Thermal safety is ensured by a thermal safety switch which will cause the compressor to shut down (65 °C / 149 °F).

• General Malfunction: If any of the conditions listed below occurs, the general malfunction

light ( an audible intermittent alarm will activate. This includes:

Note: 10 LPM Single Flow Meter Only

) will illuminate and

• Obstruction to the ow of

oxygen such as a pinch or kink in the delivery cannula, triggered by high product tank pressure

Device warning label

and alarm display.

NewLife Family

Oxygen Monitor

The oxygen monitor is a small electronic device within the NewLife Oxygen Concentrator that monitors the concentration of oxygen produced by the unit. If oxygen concentration falls below the acceptable therapeutic level, a yellow oxygen monitor light on the Oxygen Concentrator turns on. If the light remains on for more than 15 minutes, an intermittent alarm sounds.

CAUTION: Contact your Equipment Provider immediately if the yellow oxygen monitor light remains on for more than 15 minutes.

Note: When you turn the unit on, it is normal for the yellow oxygen monitor light to turn on and remain on for up to ﬁve minutes.

• High device product tank pressure condition of greater than 38 psig (±1)

• Low device product tank pressure condition of less than 15 psig (±1)

• High device temperature of greater than 135°C (275 °F), triggered by low product tank pressure if the thermal switch located within the compressor trips (shutting down the compressor)

• Oxygen Monitor: In the event the oxygen monitor detects an oxygen concentration below 82%, the low oxygen concentration warning light ( will illuminate. If the low O2 condition persists, an audible intermittent alarm will also activate.

• Power Failure: In the event the unit is operating and a loss of power occurs, the power warning light ( intermittent alarm will activate.

• Product Filter: ≥ 10 μm lter

Note: New Life Elite and Dual Flow New Life Intensity—Obstruction to the ﬂow of oxygen such as a pinch or kink in the delivery cannula will cause the ﬂow meter ball to drop to zero as an indicator of no ﬂow.

) will illuminate and an audible

)

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Page 16

NewLife Family

Operating Instructions—Dual Flow

The NewLife Intensity 10 unit’s 10-liter dual ow

option allows a single concentrator to meet the high

ow requirements of a 10 lpm patient or the needs of two patients, in any combination of ows up to

10 lpm. Excellent for use in the home, extended care facility, hopsital, or physician’s waiting room.

Primary Flowmeter

Secondary Flowmeter

Air Outlet Option

The following information will acquaint you with the Air Outlet option for the NewLife Elite Oxygen Concentrator. Make sure you read and understand all the information in this NewLife Elite Patient Manual before you operate your unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.

WARNING: IF YOU FEEL DISCOMFORT OR ARE EXPERIENCING A MEDICAL EMERGENCY, SEEK MEDICAL ASSISTANCE IMMEDIATELY.

WARNING: THIS UNIT IS NOT TO BE USED FOR LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR ANY OTHER PATIENTS UNABLE TO COMMUNICATE DISCOMFORT WHILE USING THIS MACHINE MAY REQUIRE ADDITIONAL MONITORING. PATIENTS WITH HEARING AND/OR SIGHT IMPAIRMENT(S) MAY NEED ASSISTANCE WITH MONITORING ALARMS.

Operating the NewLife Elite Air Outlet

1. Read and understand all information contained in the NewLife Elite Patient Manual’s How to Operate Your Oxygen Concentrator section before you operate your unit.

Note: The NewLife Elite Air Outlet option allows you to connect a hand held nebulizer

Figure 1: Nebulizer with tubing, valve and ﬁtting shown

Figure 2: Valve and ﬁtting shown included in Air Outlet Kit P/N KI365-1:

• Air Valve: Part No. VA007-1

• Air Outlet Barb Fitting: Part No. F0032-1

Note: You may continue to receive oxygen from the unit while you use the Air Outlet option.

Figure 1: Air Outlet option shown with hand-held nebulizer

Air Valve

Air Outlet Barb Fitting

Figure 2

2. Locate the air outlet barb tting on the front of

the unit (Figure 2). If a hand held nebulizer will be used, connect one end of the air supply tubing

to the air outlet barb tting and the other end to

the bottom of the nebulizer.

16 - ENG PN MN239 E | User Manual

Page 17

Note: Oxygen-enriched air is not delivered at the air outlet.

Note: In high humidity environments or during extended period of non-use, open the air valve completely (Figure 3) to purge/ﬂush the system.

3. Fill the nebulizer cup with medication as prescribed by your physician (Refer to the Nebulizer

with Medication section for lling instructions).

4. Operate the NewLife Elite unit for at least ve

minutes, and then open the air valve completely.

Figure 3

5. Begin your treatment (Refer to the Inhaling Medication/Treatment Instruction sections). Nebulizer medication will now be visible as a

ne mist.*

6. When treatment is complete, turn the air valve to the OFF position.

Note: The NewLife Elite Air Outlet regulator is preset to deliver 6 liters per minute ( lpm) at 12 psig (85 kPa).

NewLife Family

Filling the Nebulizer with Medication

1. Wash your hands thoroughly.

2. Use an eyedropper, syringe, or other measuring device to measure out the proper amount of medication, as prescribed by your physician.

Note: Use only the amount of medication and frequency of treatment that your physician prescribed

3. Remove or unscrew the medication cup on the nebulizer, and place your prescribed measured dosage into the medication cup (Figure 4).

4. Connect the medication cup to the nebulizer, and then connect the “T” piece or mouthpiece to the nebulizer (Figure 5).

Figure 4: Medicine into cup

7. Disconnect the nebulizer and the air supply

tubing from the air outlet barb tting.

8. Clean the nebulizer. (Refer to the Cleaning the Nebulizer section).

* If you think that your nebulizer is not operating

properly, contact your Equipment Provider.

Figure 5: Nebulizer mouthpiece

5. Connect one end of the air supply tubing to the

air outlet barb tting and the other end to the

bottom of the nebulizer, and open the air valve completely as shown in Figure 3.

6. Begin your treatment. (Refer to the Inhaling Medication/Treatment Instruction section)

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NewLife Family

Inhaling Medication/Treatment Instructions

Note: The following instructions for inhaling medication are often recommended. If your physician or health care professional has given you special instructions, make sure you follow them instead, as prescribed.

1. Close your mouth around the mouthpiece, but do not hold it with your teeth (Figure 6).

Cleaning the Nebulizer

Note: Perform steps 1 and 2 below after each treatment to prevent medication from collecting and hardening inside the nebulizer parts.

1. After each treatment, separate the nebulizer and the “T” piece or mouthpiece assembly.

2. Remove or unscrew the nebulizer cup, and rinse each component thoroughly in warm water.

3. Once a day, clean all nebulizer parts (excluding air supply tubing) with a mild detergent or soap solution in warm water. Rinse thoroughly, and soak all parts in a solution of one (1) part white vinegar and three (3) parts water for 30 minutes to disinfect.

2. Take a slow, deep breath, and pause at the end of

Figure 6: Mouthpiece

the inhalation for 1-2 seconds, then exhale slowly and completely.

3. Repeat this procedure until the prescribed amount of medication nebulizes or the Prescribed amount of treatment time elapses (whichever

occurs rst).

4. If your physician or health care professional instructed you to take short rest periods During your treatment, make sure you turn the air valve to the OFF position. This will conserve your medication.

Note: Prolonged treatment time can indicate a defective nebulizer. Contact your Equipment Provider if this condition exists.

4. Rinse thoroughly in warm water to remove the

Figure 7

disinfectant solution.

5. Place all nebulizer parts on a paper towel or soft absorbent material to air dry. DO NOT WIPE D RY.

6. When dry, store the nebulizer parts in a clean container or plastic bag.

7. Repeat the above procedure after each treatment/ patient use.

CAUTION: Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider.

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NewLife Family

Materials in Direct or Indirect Contact with Operator

NewLife Elite:

Concentrator casing .............................. Valtra/ABS

Mains cable ......................................................PVC

Dust lter ..................................................Polyester

ON/OFF switch ................................ Thermoplastic

Casters ............................................................Nylon

Flow adjustment knob ..............ABS/Polycarbonate

Gas outlet ...............................Chrome Plated Brass

Printed labels ..................................................Lexan

NewLife Intensity 10:

Concentrator casing .......... Valtra/ABS/Polystyrene

Mains cable ......................................................PVC

Dust lter ..................................................Polyester

ON/OFF switch ................................ Thermoplastic

Casters ............................................................Nylon

Flow adjustment .......................ABS/Polycarbonate

Gas outlet ...............................Chrome Plated Brass

Printed labels ..................................................Lexan

Cleaning, Care, and Proper Maintenance

WARNING: CLEAN THE CABINET, CONTROL PANEL, AND POWER CORD ONLY WITH A MILD HOUSEHOLD CLEANER APPLIED WITH A DAMP (NOT WET) CLOTH OR SPONGE, AND THEN WIPE ALL SURFACES DRY. DO NOT ALLOW ANY LIQUID TO GET INSIDE THE CONCENTRATOR. PAY SPECIAL ATTENTION TO THE OXYGEN OUTLET FOR THE CANNULA CONNECTION TO MAKE SURE IT REMAINS FREE OF DUST, WATER, AND PARTICLES.

Cabinet

Turn OFF the unit and disconnect from power before any cleaning or disinfection. DO NOT spray the outer case directly. Use a damp (not wet) cloth or sponge. Spray the cloth or sponge with a mild detergent solution to clean the cabinet. Proceed as directed by the cleaner manufacturer. Device cabinet should be cleaned at minimum between users.

WARNING: DO NOT USE OIL, GREASE, OR PETROLEUM-BASED OR OTHER FLAMMABLE PRODUCTS WITH THE OXYGEN-CARRYING ACCESSORIES OR THE OXYGEN CONCENTRATOR. OXYGEN ACCELERATES THE COMBUSTION OF FLAMMABLE SUBSTANCES.

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Page 20

NewLife Family

WARNING: USE ONLY WATER-BASED LOTIONS OR SALVES THAT ARE OXYGEN COMPATIBLE PRIOR TO OR DURING OXYGEN THERAPY. NEVER USE PETROLEUM OR OIL-BASED LOTIONS OF SALVES TO AVOID THE RISK OF FIRE OR BURNS.

WARNING: DO NOT USE LIQUID DIRECTLY ON THE UNIT. A LIST OF UNDESIRABLE CHEMICAL AGENTS INCLUDES BUT IS NOT LIMITED TO THE FOLLOWING: ALCOHOL AND ALCOHOL-BASED PRODUCTS, CONCENTRATED CHLORINE-BASED PRODUCTS (ETHYLENE CHLORIDE), AND OILBASED PRODUCTS (PINE-SOL ARE NOT TO BE USED TO CLEAN THE PLASTIC HOUSING ON THE OXYGEN CONCENTRATOR, AS THEY CAN DAMAGE THE UNIT’S PLASTIC. CLEAN THE CABINET, CONTROL PANEL, AND POWER CORD ONLY WITH A MILD HOUSEHOLD CLEANER APPLIED WITH A DAMP CLOTH (NOT WET) OR SPONGE, AND THEN WIPE ALL SURFACES DRY. DO NOT ALLOW ANY LIQUID TO GET INSIDE THE DEVICE.

Note: The Manufacturer does not recommend the sterilization of this equipment.

, LESTOIL®). THESE

CAUTION: It is very important to select only the prescribed level of oxygen. Do not change the ﬂow selection unless you have been directed to do so by a licensed clinician.

CAUTION: The Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician.

Cannula Replacement

Always follow the cannula manufacturer’s instructions for proper use. Replace the nasal cannula or oxygen tubing as recommended by the cannula manufacturer or your oxygen provider. Your physician or oxygen provider will provide you with cleaning and replacement instructions.

Additional supplies for replacement are available through your oxygen provider.

Filters

At least one time each week, wash the air intake

gross particle lter, which is located in the back

of the unit. Your Equipment Provider may advise you to clean it more often, depending upon your operating conditions. Follow these steps to properly

clean the air intake lter:

Note: Do not operate the unit without the intake gross particle ﬁlter in place.

1. Remove the lter and wash it in a warm solution

of soap and water.

2. Rinse the lter thoroughly, and remove excess

water with a soft, adsorbent towel. Ensure that the

lter is completely dry before replacing it.

3. Replace the dry lter.

Reserve Oxygen Supply

Your Equipment Provider may recommend another source of supplemental oxygen therapy in case there is a mechanical failure or a power outage.

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Page 21

Alarm Conditions

All alarms are low priority alarms.

Alarm Indicates Action

General malfunction yellow

light audible alarm

Oxygen monitor yellow light

audible alarm

Power failure yellow light

audible alarm

and intermittent

High Product Tank Pressure OR Low Product Tank Pressure OR High Device Temperature OR No Flow (10 LPM Single Flow Meter Only)

Low Oxygen Concentration

Power Failure Ensure device is plugged into a known, working

Ensure ﬂowmeter is open to minimum ﬂow rate or higher. Ensure cannula is not kinked or obstructed. Remove any devices connected downstream of the outlet of the device. Ensure device has at least 12" of clearance on all sides and intakes are not obstructed. Ensure external gross particle intake ﬁlter is clean and not clogged. Ensure unit is within operating temperature range. If issue persists, contact equipment provider for service.

Contact equipment provider for service.

outlet. Ensure breaker switch is pushed in. If issue persists contact equipment provider for service.

NewLife Family

Troubleshooting

If your NewLife Oxygen Concentrator fails to operate properly, refer to the chart on the following pages for possible causes and solutions and, if needed, consult your Equipment Provider.

If you cannot get the unit to operate, connect your nasal cannula, face mask, or other accessories to a reserve supplemental oxygen supply.

Note: Do not attempt any maintenance other than the possible solutions listed within this manual.

Note: To prevent a void warranty, follow all manufacturers’ instructions.

Problem Probable Cause Solution

Unit does not operate. Power failure condition causes an alarm to sound.

Power cord not connected into electrical outlet.

No power at electrical outlet. Check power source, wall switch, fuse, or

Oxygen concentrator circuit breaker is activated.

Check power cord plug at the electrical outlet for a proper connection.

circuit breaker in-house.

Contact your Equipment Provider for service.

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Page 22

NewLife Family

Limited oxygen ﬂow. Dirty or obstructed humidiﬁ-

Condensation collects in the oxygen tubing when you use the humidiﬁer bottle.

Intermittent alarm sounds. Equipment malfunction. Set I/0 power switch to 0 position, use your

NewLife Family displays alarm and produces intermittent beep.

Oxygen concentrator does not turn on.

All other problems. Set I/0 power switch to the 0 position, use

er bottle.

Defective nasal cannula, face mask, catheter, and/ or oxygen delivery tube, or other accessory.

Other leak or restriction. Disconnect delivery tubing at oxygen outlet

Unit not properly ventilated. Elevated operating temperature.

Refer to Alarm Conditions table.

Not connected to external power.

General malfunction.

Remove the humidiﬁer bottle (if used) from the oxygen outlet. If ﬂow is restored, clean or replace with a new humidiﬁer bottle.

Remove nasal cannula, face mask, or other accessories from oxygen tubing. If proper ﬂow is restored, replace with new nasal cannula, face mask, or other accessories.

(front of unit). If proper ﬂow is restored, check oxygen tubing for kinks or obstructions. Replace if needed.

Contact your Equipment Provider.

Make sure unit is positioned away from curtains or drapes, hot air registers, heaters, and ﬁreplaces. Be certain to place the unit so all sides are at least 12 inches (30.5 cm) away from a wall or other obstruction. Do not place the unit in a conﬁned area.

Allow oxygen tubing to dry out, or replace with new tubing. Reﬁll humidiﬁer bottle with COLD water. DO NOT OVERFILL.

reserve oxygen supply and consult your Equipment Provider immediately.

Refer to Alarm Conditions table.

Power the unit through the outlet.

Ensure that external connects are secure.

Contact your Equipment Provider, and change to another source of oxygen as necessary.

your reserve oxygen supply and consult your Equipment Provider immediately.

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Accessories

NewLife Family

For proper performance and safety, use only these listed accessories supplied by CAIRE through your oxygen provider. Use of accessories not listed below could adversely affect the performance and/ or safety of the concentrator. The following oxygen administration accessories are recommended for use with the NewLife Oxygen Concentrator.

NewLife Family Standard Accessories

Nasal Cannula with 7 feet (2.1 m) of tubing (6 LPM max)

Oxygen Outlet Adapter F0025-1

Face Mask with 7 feet (2.1 m) of tubing (10 LPM max)*

Humidiﬁer Adapter Extension HU002-1

Humidiﬁer Bottle for Elite models (6-15 LPM)

CU002-1

MS013-1

HU003-1

Humidiﬁer Bottle for Intensity models (6-15 LPM)

SureFlow FM069

*Face mask should only be used with NewLife Intensity 10 models.

Note: Additional options may be available for country-speciﬁc power cords where noted above. Contact CAIRE or your oxygen provider if alternate options are needed for order.

WARNING: PREGNANT OR NURSING WOMEN SHOULD NOT USE ACCESSORIES RECOMMENDED IN THIS MANUAL, THEY MAY CONTAIN PHTHALATES.

HU014-1

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Page 24

NewLife Family

EMC Testing

Medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section.

Guidance and Manufacturer’s Declaration —Electromagnetic Emissions

The NewLife is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NewLife should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11

RF emissions

CISPR 11 Harmonic emissions

IEC 61000-3-2 Voltage ﬂuctuations/

ﬂicker emissions IEC 61000-3-3

Group 1

Class B

Complies

The NewLife 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.

The NewLife 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.

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NewLife Family

Guidance and Manufacturer’s Declaration± Electromagnetic Immunity

The NewLife is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NewLife should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment ±

Electromagnetic environment – guidance

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

N/A

±1 kV line(s) to

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

line(s)

±2 kV line(s) to line(s)

<5 % U

(>95 % dip in U

for 0,5 cycle

)

<5 % U

(>95 % dip in U

for 0,5 cycle

guidance

Floors should be wood, concrete or ceramic tile. If ﬂoors are covered with synthetic material, the relative humidity should be at least 30 %.

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

40 % U

(60 % dip in U

for 5 cycles

70 % U

(30 % dip in U

for 25 cycles

<5 % U

(>95 % dip in U

for 5 sec

)

40 % U

(60 % dip in U

for 5 cycles

70 % U

(30 % dip in U

for 25 cycles

<5 % U

(>95 % dip in U

for 5 sec

Power frequency (50/60 Hz) magnetic ﬁeld IEC

3 A / m 3 A / m

61000-4-8

NOTE U

is the A.C. mains voltage prior to application of the test level.

Mains power quality should be that of a

)

typical commercial or hospital environ-

ment. If the user of the NewLife Family requires continued operation during

power mains interruptions, it is recommended that the NewLife is powered from an uninterruptible power supply

)

(UPS) or a battery.

)

Power frequency magnetic ﬁelds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Page 26

NewLife Family

Pd 2.1

Guidance and Manufacturer’s Declaration ± Electromagnetic Immunity

The NewLife is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NewLife should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment ±

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3 V/m

guidance

Portable and mobile RF communications equipment should be used no closer to any part of the NewLife, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

from 80 MHz to 800 MHz

from 800 MHz to .5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from ﬁxed RF transmitters, as determined by an electromagnetic site survey,

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.

Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 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 NewLife Family is used exceeds the applicable RF compliance level above, the NewLife should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the NewLife Family.

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

26 - ENG PN MN239 E | User Manual

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NewLife Family

Pd 2.1

Recommended separation distances between portable and mobile RF communications equipment and the NewLife Units

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

Rated maximum output power of

transmitter

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73 1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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.

Separation distance according to frequency of transmitter

(m)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Classiﬁcation

Type of protection against electric shock: Class II Protection from electric shock is achieved by double insulation. Protective earthing or reliance upon installation conditions are not required.

Degree of protection against electric shock: Type BF Equipment providing a particular degree of protection against electric shock regarding

1) allowable leakage current;

2) reliability of protective earth connection (if present). Not intended for direct cardiac application.

Degree of protection against harmful ingress of water: Drip-proof equipment – IP21. Protection against ingress of solid foreign objects greater than 12.5 mm diameter, and protection against vertically falling drops of water.

Method of cleaning and infection control allowed: Please refer to Maintenance section in the NewLife Service Manuals.

Degree of safety of application in the presence of

ammable anesthetic gases:

Equipment not suited for such application.

Mode of operation: Continuous duty.

PN MN239 E | User Manual ENG - 27