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NewLife ® Family
User Manual
(English)
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
Operating temperature limitation of these units is 41°F to 104°F (5°C to
40°C). Storage temperature limitation range is -13°F to +158°F (-25°C to
+70°C). Reg. # 0632
Humidity range is 10 to 95%. 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
Authorized representative in the
European Community
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. It bears the CE marking as shown.
Internal Symbols
Keep away from flammable materials, oil and grease.
Safety agency for CAN/CSA
C22.2 No. 60601-1-14 for medical electrical equipment. Certified 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)
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 flame, fire, 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
Warning. Reg. # W001
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.
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)
Council Directive 93/42/EEC; concerning medical devices
2 - ENG PN MN239 B | User Manual
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.: patents.cairemedical.com.
NewLife Family
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 flow 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 significant number of these people can benefit 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 flow 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 flow rate.
PN MN239 B | User Manual ENG - 3
NewLife Family
WARNING: “NO SMOKING – OXYGEN
IN USE” SIGNS MUST BE PROMI-
NENTLY 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.
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.
Operator Profile
Concentrators are intended to supply supplemental oxygen to users suffering from discomfort due to ailments which effect the efficiency 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 refilled, and can recharge anywhere AC or DC power.
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 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
4 - ENG PN MN239 B | User Manual
NewLife Family
Getting to Know Your NewLife Oxygen Concentrator
First, become familiar with the important parts of your NewLife Oxygen Concentrator (Figures 1a,
1b, and 1c).
D
E
F
G
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 flow rate in liters per minute
(lpm).
E. Oxygen Outlet: Provides connections for a humidifier (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.
C
B
A
Figure 1a
F
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 AD-
VERSELY 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.
H
I
Figure 1c
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.
PN MN239 B | User Manual ENG - 5
NewLife Family
Indications for Use
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.
WARNING: DO NOT OPERATE THIS EQUIPMENT
WITHOUT FIRST READING AND UNDERSTAND-
ING THIS MANUAL. IF YOU ARE UNABLE TO UN-
DERSTAND THE WARNINGS AND INSTRUCTIONS,
CONTACT YOUR EQUIPMENT PROVIDER BEFORE
ATTEMPTING TO USE THIS EQUIPMENT; OTHER-
WISE 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 ACCES-
SORIES.
WARNING: SMOKING WHILE WEARING AN OXY-
GEN 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.
Contraindications for Use
WARNING: IN CERTAIN CIRCUM-
STANCES, THE USE OF NON-PRE-
SCRIBED OXYGEN CAN BE HAZARD-
OUS. 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 AD-
VERSE HEALTH CONSEQUENCES AS THE RESULT
OF SUCH TEMPORARY INTERRUPTION.
Safety Guidelines
WARNING: CAREFULLY REVIEW AND
FAMILIARIZE YOURSELF WITH THE
FOLLOWING IMPORTANT SAFETY
INFORMATION ABOUT THE NEWLIFE
INTENSITY OXYGEN CONCENTRATOR.
WARNING: IF YOU SMOKE, YOU MUST
ALWAYS FOLLOW THESE THREE (3) IM-
PORTANT STEPS FIRST: TURN OFF THE
OXYGEN CONCENTRATOR, TAKE OFF
THE CANNULA, AND LEAVE THE ROOM
WHERE THIS DEVICE IS LOCATED.
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 IN-
FORMED ABOUT THE DANGERS OF SMOKING IN
THE PRESENCE OF, OR WHILE USING, MEDICAL
OXYGEN.
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-CON-
CENTRATION 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 ACCES-
SORY. FAILURE TO OBSERVE THIS WARNING CAN
RESULT IN SEVERE FIRE, PROPERTY DAMAGE
AND / OR CAUSE PHYSICAL INJURY OR DEATH.
6 - ENG PN MN239 B | User Manual
WARNING: DO NOT USE YOUR OXYGEN CON-
CENTRATOR 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 MATERI-
AL 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 PETRO-
LEUM-BASED OR OTHER FLAMMABLE PROD-
UCTS WITH THE OXYGEN-CARRYING ACCESSO-
RIES OR THE OXYGEN CONCENTRATOR. OXYGEN
ACCELERATES THE COMBUSTION OF FLAMMA-
BLE 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, CON-
NECTIONS, 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 MAL-
FUNCTION OR SHUT DOWN, AND CAUSE AN
INCREASED RISK FOR ELECTRICAL SHOCK 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 OIL-
BASED PRODUCTS (PINE-SOL ® , LESTOIL ® ). THESE
ARE NOT TO BE USED TO CLEAN THE PLASTIC
HOUSING ON THE OXYGEN CONCENTRATOR, AS
THEY CAN DAMAGE THE UNIT’S PLASTIC.
NewLife Family
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 EQUIP-
MENT 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 ELEC-
TRICAL EQUIPMENT AS REPLACEMENT PARTS
FOR INTERNAL COMPONENTS, MAY RESULT IN
INCREASED EMISSIONS OF DECREASED IMMU-
NITY OF THE OXYGEN CONCENTRATOR.
WARNING: USE ONLY ELECTRICAL
VOLTAGE AS SPECIFIED ON THE
SPECIFICATION LABEL AFFIXED TO THE
DEVICE.
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 CAUS-
ING THE BREAKER/FUSE TO ACTIVATE OR FIRE IF
THE BREAKER OR FUSE FAILS TO OPERATE.
WARNING: ENVIRONMENTAL CONDITIONS CAN
AFFECT PERFORMANCE OF DEVICE. LOCATE IN
CLEAN, PEST-FREE ENVIRONMENT.
WARNING: DEVICE SHOULD ONLY BE OPERAT-
ED BY END USERS, TRAINED CAREGIVERS, OR
TRAINED TECHNICIANS. CHILDREN SHOULD NOT
OPERATE THE DEVICE.
PN MN239 B | User Manual ENG - 7
NewLife Family
WARNING: USE OF THIS DEVICE AT AN ALTITUDE
ABOVE 3048 METERS (10,000 FEET) OR OUTSIDE
A TEMPERATURE OF 50 ° F TO 104 ° F (10°C TO
40°C) OR A RELATIVE HUMIDITY ABOVE 95% IS
EXPECTED TO ADVERSELY AFFECT THE FLOW-
RATE AND THE PERCENTAGE OF OXYGEN AND
CONSEQUENTLY THE QUALITY OF THE THERAPY.
WARNING: THE USE OF SOME OXYGEN ADMIN-
ISTRATION 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 SPECIF-
IC 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: 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.
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.
8 - ENG PN MN239 B | User Manual
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.
NewLife Family
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 Oxygen Concentrator:
• Nasal Cannula with 7 feet (2.1 m) of tubing:
CU002-1
• For any additional recommended accessories, please see the Accessories Catalog (PN ML-
LOX0010) available on www.CAIREmedical.com.
A firebreak is required for use with any cannula.
• CAIRE offers the OxySafe™. This is intended to be used in conjunction with the oxygen concentrator.
The OxySafe™ 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 OxySafe.
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 OxySafe, always refer to the manufacturer’s instructions (included with each
OxySafe kit).
CAIRE offers an OxySafe™ kit that includes a cannula headpiece, OxySafe™, and 7’ tubing: PN
20629671.
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.
PN MN239 B | User Manual ENG - 9
NewLife Family
Specifications
Flow Rates*
Dimensions
NewLife Elite
1–5 LPM
±10% of indicated setting, or 200 mL, whichever is greater**
28.5 x 15.7 x 14.5 in
(72.4 x 40.0 x 36.8 cm)
54 lbs (24.5 kg)
48 dB(A) at flow rates of 1 to 5 LPM
NewLife Intensity 10
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)
58 lbs (26.3 kg)
58 dB(A) at flow rates of 2 to 10 LPM
Weight
Sound Pressure
Level
Power
Consumption
O2 Concentration
Output Pressure
Operating
Environment*
Altitude
Storage
Environment
Warranty
Maintenance
Schedule
Max Tubing
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
1-3 lpm: 95.5% - 92.0%
4 lpm: 92% ± 3%
5 lpm: 90% ± 3%
7 psi (48 kPA)
41° to 104°F (5° to 40°C)
15–95% 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),
15–95% Humidity (non-condensing)
3 Years
Felt Filter (230 V only) – 1 Year Replacement
Intake Filter – Clean Weekly
50 ft (15.2 m)
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
2–9 LPM: 92%+3.5%/-3%, 10 LPM:
90%+5.5%/-3%
20 psig (138 kPA)
41°F to 104°F (5°C to 40°C), 15–95% 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), 15-
95% Humidity (non-condensing)
3 Years
Felt Filter – 1 Year Replacement, Intake
Filter – Clean Weekly
200 ft (61 m)
* 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, flow meter accuracy may be affected up to 13%.
The expected service life of this device is a minimum of five years.
See technical manual (PN MN240-1) for sound power level.
10 - ENG PN MN239 B | User Manual
NewLife Family
Operating Instructions
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 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.
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 humidifier
(if required), nasal cannula, face mask, catheter, and/or extension tubing to the oxygen outlet.
5. Completely unwrap the power cord.
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 flowmeter adjustment knob to the prescribed LPM. The concentrator is now ready for use.
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.
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.
WARNING: “NO SMOKING – OXYGEN
IN USE” SIGNS MUST BE PROMI-
NENTLY 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.
CAUTION: If the alarm is weak or does not sound at all, consult your
Equipment Provider immediately.
PN MN239 B | User Manual ENG - 11
NewLife Family
WARNING: THIS DEVICE SUPPLIES HIGH-CON-
CENTRATION 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 ACCES-
SORY. FAILURE TO OBSERVE THIS WARNING CAN
RESULT IN SEVERE FIRE, PROPERTY DAMAGE
AND / OR CAUSE PHYSICAL INJURY OR DEATH.
WARNING: DO NOT USE YOUR OXYGEN CON-
CENTRATOR 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 MATERI-
AL 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 PETRO-
LEUM-BASED OR OTHER FLAMMABLE PROD-
UCTS WITH THE OXYGEN-CARRYING ACCESSO-
RIES OR THE OXYGEN CONCENTRATOR. ONLY
WATER BASED, OXYGEN COMPATIBLE LOTIONS
OR SALVES SHOULD BE USED. OXYGEN ACCEL-
ERATES THE COMBUSTION OF FLAMMABLE
SUBSTANCES.
WARNING: THE USE OF SOME OXYGEN ADMIN-
ISTRATION 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.
Proper Setting of Oxygen Flowmeter
To set the proper flow of supplemental oxygen, turn the flowmeter adjustment knob left or right until the ball inside the flowmeter centers on the flow line number prescribed by your physician.
Elite (top) and Intensity (bottom)
To view the flowmeter at the proper angle, note that the back line and the front numbered line must give the appearance of just one line.
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.
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.
12 - ENG PN MN239 B | User Manual
Filters
Air enters the NewLife unit through an air intake gross particle filter located on the back off the oxygen concentrator. This filter removes dust particles and other large particles from the air. Before you operate the NewLife unit, make sure this filter is clean and positioned correctly.
NewLife Family
Operating With Humidifier
Following these steps if your physician prescribed an oxygen humidifier as part of your therapy:
1. Remove or unscrew the reservoir bottle from the humidifier (If you have a pre-filled unit do not perform this step. Proceed directly to step 4.)
2. Fill the reservoir with cool or cold water (distilled water is preferred) to the fill line indicated on the bottle. DO NOT OVERFILL.
3. Screw the reservoir bottle back together.
The supplemental oxygen produced by the NewLife unit receives additional filtration from a product filter (for particle size 10 micron or greater) located within the oxygen concentrator. Your equipment
Provider performs maintenance on the product filter in addition to other maintenance on the unit.
Operating Without Humidifier
1. If your physician did not prescribe a humidifier, connect the oxygen tubing directly to the unit’s oxygen outlet. A separate outlet fitting is supplied for this type of connection.
4. On the top of the humidifier, turn the thread nut counterclockwise while you connect the humidifier to the oxygen outlet, and tighten securely
(Figure 6).
5. Connect oxygen tubing from the nasal cannula, face mask, or other accessories to the humidifier outlet fitting.
PN MN239 B | User Manual ENG - 13
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.
If not, follow the manufacturer’s instructions for proper connection. Connect the oxygen tubing to the oxygen outlet adapter or humidifier.
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
• OxySafe Kit w/ Cannula & 7 ft. tube (Flow 25 LPM max. Pressure 87 PSIG max.): Part No. 20628667
• OxySafe Kit w/ DISS tubing adapter (Flow 25 LPM max. Pressure 87 PSIG max.): Part No. 20628668
*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.
14 - ENG PN MN239 B | User Manual
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.
NewLife Family
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.
• Compressor Motor: A pressure relief valve is fitted to the compressor outlet and is calibrated to 280 kPa (40 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 ( ) will illuminate and an audible intermittent alarm will activate. This includes:
• Obstruction to the flow of oxygen such as a pinch or kink in the delivery cannula, triggered by high product tank pressure
Device warning label and alarm display.
Note: 10 LPM Single Flow Meter Only
• 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: The oxygen monitor detects any drop in concentration below 82%. If this occurs the low oxygen concentration warning light
( ) will illuminate. If the low O2 condition persists, an audible intermittent alarm will also activate in addition to the alarm light. See Figure
10.
• Power Failure: In the event the unit is operating and a loss of power occurs, the power warning light ( ) will illuminate and an audible intermittent alarm will activate. See Figure 10.
• Product Filter: ≥ 10 μm filter
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.
PN MN239 B | User Manual ENG - 15
NewLife Family
Operating Instructions—Dual Flow
The NewLife Intensity 10 unit’s 10-liter dual flow option allows a single concentrator to meet the high flow requirements of a 10 lpm patient or the needs of two patients, in any combination of flows up to
10 lpm. Excellent for use in the home, extended care facility, hopsital, or physician’s waiting room.
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.
Primary
Flowmeter
Secondary
Flowmeter
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.
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 ASSIS-
TANCE 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.
Figure 1: Air Outlet option shown with hand-held nebulizer
Air Valve
Air Outlet
Barb Fitting
Figure 2
2. Locate the air outlet barb fitting 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 fitting and the other end to the bottom of the nebulizer.
16 - ENG PN MN239 B | User Manual
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 filling instructions).
4. Operate the NewLife Elite unit for at least five minutes, and then open the air valve completely.
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 3
5. Begin your treatment (Refer to the Inhaling
Medication/Treatment Instruction sections).
Nebulizer medication will now be visible as a fine 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).
7. Disconnect the nebulizer and the air supply tubing from the air outlet barb fitting.
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 4: Medicine into cup
Figure 5: Nebulizer mouthpiece
5. Connect one end of the air supply tubing to the air outlet barb fitting 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)
PN MN239 B | User Manual ENG - 17
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.
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. Close your mouth around the mouthpiece, but do not hold it with your teeth (Figure 6).
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.
Figure 6: Mouthpiece
2. Take a slow, deep breath, and pause at the end of 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 first).
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.
Figure 7
4. Rinse thoroughly in warm water to remove the disinfectant solution.
5. Place all nebulizer parts on a paper towel or soft absorbent material to air dry. DO NOT WIPE
DRY.
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.
18 - ENG PN MN239 B | User Manual
NewLife Family
Materials in Direct or Indirect Contact with Operator
NewLife Elite:
Concentrator casing .............................. Valtra/ABS
Mains cable ......................................................PVC
Dust filter ..................................................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 filter ..................................................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 AC or DC 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: 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 EQUIP-
MENT 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 MAL-
FUNCTION OR SHUT DOWN, AND CAUSE AN
INCREASED RISK FOR ELECTRICAL SHOCK OR
BURNS.
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.
PN MN239 B | User Manual ENG - 19
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 OIL-
BASED PRODUCTS (PINE-SOL ® , LESTOIL ® ). THESE
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: 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.
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.
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 filter, 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 filter:
Note: Do not operate the unit without the intake gross particle filter in place.
1. Remove the filter and wash it in a warm solution of soap and water.
2. Rinse the filter thoroughly, and remove excess water with a soft, adsorbent towel. Ensure that the filter is completely dry before replacing it.
3. Replace the dry filter.
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.
20 - ENG PN MN239 B | User Manual
NewLife Family
Alarm Conditions
All alarms are low priority alarms.
Alarm
General malfunction yellow light and intermittent audible alarm
Indicates
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
Action
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.
Oxygen monitor yellow light
and intermittent audible alarm
Power failure yellow light
and intermittent audible alarm
Power Failure Ensure device is plugged into a known, working outlet. Ensure breaker switch is pushed in. If issue persists contact equipment provider for service.
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
Unit does not operate. Power failure condition causes an alarm to sound.
Probable Cause
Power cord not connected into electrical outlet.
Solution
Check power cord plug at the electrical outlet for a proper connection.
No power at electrical outlet. Check power source, wall switch, fuse, or circuit breaker in-house.
Oxygen concentrator circuit breaker is activated.
Contact your Equipment Provider for service.
PN MN239 B | User Manual ENG - 21
NewLife Family
Limited oxygen flow.
Dirty or obstructed humidifier bottle.
Condensation collects in the oxygen tubing when you use the humidifier bottle.
Unit not properly ventilated. Elevated operating temperature.
All other problems.
Defective nasal cannula, face mask, catheter, and/ or oxygen delivery tube, or other accessory.
Other leak or restriction.
Intermittent alarm sounds.
Equipment malfunction.
NewLife Family displays alarm and produces intermittent beep.
Oxygen concentrator does not turn on.
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.
Disconnect delivery tubing at oxygen outlet
(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.
Set I/0 power switch to 0 position, use your reserve oxygen supply and consult your Equipment Provider immediately.
Refer to Alarm Conditions table.
Power the unit through the AC or DC outlet.
Ensure that external connects are secure.
Contact your Equipment Provider, and change to another source of oxygen as necessary.
Set I/0 power switch to the 0 position, use your reserve oxygen supply and consult your
Equipment Provider immediately.
22 - ENG PN MN239 B | User Manual
NewLife Family
Accessories
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)
CU002-1
Oxygen Outlet Adapter
Face Mask with 7 feet (2.1 m) of tubing (10 LPM max)*
F0025-1
MS013-1
Humidifier Adapter Extension
Humidifier Bottle for Elite models (6-15 LPM)
Humidifier Bottle for Intensity models (6-15 LPM)
HU002-1
HU003-1
HU014-1
OxySafe Kit w/ Cannula & 7 ft. tube (Flow 25 LPM max.
Pressure 87 PSIG max.)
OxySafe Kit w/ DISS tubing adapter (Flow 25 LPM max.
Pressure 87 PSIG max.)
20628667
20628668
*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 ACCESSO-
RIES RECOMMENDED IN THIS MANU-
AL, THEY MAY CONTAIN PHTHALATES.
PN MN239 B | User Manual ENG - 23
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
Group 1
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.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Class B
Complies
Complies
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.
24 - ENG PN MN239 B | User Manual
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 ± guidance
Electromagnetic environment – guidance
±6 kV contact
±8 kV air
IEC 61000-4-2
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/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
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
Mains power quality should be that of a typical commercial or hospital environment.
<5 % U
T
(>95 % dip in U
T
) for 0,5 cycle
±2 kV line(s) to line(s)
<5 % U
T
(>95 % dip in U
T
) for 0,5 cycle
Voltage dips, short interruptions and voltage variations on power supply input lines IEC
61000-4-11
40 % U
T
(60 % dip in U
T
) for 5 cycles
70 % U
T
(30 % dip in U for 25 cycles
T
)
40 % U
(60 % dip in U for 5 cycles
70 % U
T
T
(30 % dip in U
T for 25 cycles
T
)
)
Mains power quality should be that of a typical commercial or hospital environment. 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.
<5 % U
T
(>95 % dip in U
T
) for 5 sec
<5 % U
T
(>95 % dip in U
T
) for 5 sec
Power frequency
(50/60 Hz) magnetic field IEC
61000-4-8
3 A / m 3 A / m
NOTE U
T
is the A.C. mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
PN MN239 B | User Manual ENG - 25
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
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
Electromagnetic environment ± 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 d 1 .
2 P d 1 .
2 P
from 80 MHz to 800 MHz d 1 .
2 P
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, 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 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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
26 - ENG PN MN239 B | User Manual
NewLife Family
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
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
(m)
80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
0.01 d 1 .
2
0.12
P d 1 .
2
0.12
P d 1 .
2
0.23
P
0.1
1
10
0.38
1.2
3.8
0.38
1.2
3.8
0.73
2.3
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.
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 flammable anesthetic gases:
Equipment not suited for such application.
Mode of operation:
Continuous duty.
PN MN239 B | User Manual ENG - 27
CAIRE Inc.
2200 Airport Industrial Dr., Ste 500
Ball Ground, GA 30107 www.CAIREmedical.com
Medical Product Services GmbH
Borngasse 20
35619 Braunfels, Germany
Tel: +49 (0) 6442-962073
E-mail: [email protected]
Worldwide: www.CAIREmedical.com
Copyright © 2018 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its products, or change the prices, materials, equipment, quality, descriptions, specifications and/or processes to its products at any time without prior notice and with no further obligation or consequence. All rights not expressly stated herein are reserved by us, as applicable.
|MN239_Br~
PN MN239 B

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