CAIRE HELiOS Series, HELiOS Marathon, HELiOS Plus User Manual

HELiOS
TM
Series
User Manual (English)
HELiOS 300 & 800
Symbols Glossary
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 14°F to 104°F (-10°C to 40°C). Storage temperature limitation range is -40°F to 158°F (-40°C to 70°C). Reg. # 0632
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
Warning. Reg. # W001
Council Directive 93/42/EEC; concerning medi­cal devices
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. This device complies with the re­quirements of Directive 2010/35/EU concerning medical devices. It bears the pi marking as shown.
ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
Non-toxic gas.
Hazard Oxidizing substances: re
intensifying risk. Oxidizing agents
cause res to burn more vigorously.
Refrigerated Liquid, USP; Produced by Air Liquefaction
Internal Symbols
Keep unit well ventilated at all times
ISO 7010: Graphical symbols—Safety colors and safety signs—Registered safety signs
Frostbite may occur on contact with cold liquid or gaseous oxygen, or frosted parts. Warning low tempera­ture. To warn of low temperature or freezing conditions. Reg. # W010
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
2 - ENG PN 21033264 B | User Manual
Keep away from ammable materials,
oil and grease.
Portable Empty
Portable Full
Always keep Portable in one of the
following positions: upright, at on
its back, or any position in between.
Wipe connector with clean dry cloth
before lling.
HELiOS 300 & 800
IEC 60417: Graphical Symbols for use on equipment
Do not cover unit or carry portable unit under your clothing. These units normally vent oxygen. No. 5641
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.
Council Directive 2012/19/EU: waste electrical and electronic equipment (WEEE)
WEEE
IEC 60601-1: Medical electrical equipment Part 1 General requirements for basic safety and essential performance
Drip Proof
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.
Warning Information
Important: Read this manual thoroughly before operating the H300/H850.
WARNING: A WARNING IDENTI­FIES A SITUATION WHICH, IF NOT AVOIDED, COULD RESULT IN DEATH OR SERIOUS INJURY. A WARNING MAY ALSO DESCRIBE POTENTIAL SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS.
WARNING: THIS DEVICE IS NOT INTENDED FOR LIFE SUSTAINING USE. IF CONTINUITY OF OXYGEN SUPPLY IS REQUIRED, ENSURE THAT AN ADEQUATE SUPPLY OF OXYGEN AND/OR A SECONDARY OXYGEN SUPPLY IS AVAILABLE AT ALL TIMES DURING THERAPY.
WARNING: IF YOU FEEL THE EQUIPMENT IS NOT OPERATING PROPERLY, CALL YOUR HEALTH CARE PROVIDER. DO NOT ATTEMPT TO REPAIR OR ADJUST THE UNIT YOURSELF.
WARNING: DO NOT MODIFY THIS EQUIPMENT WITHOUT AUTHORIZATION FROM THE MANU­FACTURER.
WARNING: THE POSSIBILITY OF FIRE EXISTS WHEN THE COMBI­NATION OF A FUEL, SOURCE OF IGNITION, AND OXYGEN IS PRESENT. HIGH CONCENTRATIONS OF OXY­GEN (AIR IS APPROXIMATELY 21% OXYGEN) GREATLY ENHANCE THE POSSIBILITY OF COMBUSTION.
WARNING: THE UNIT CONTAINS LIQUID OXYGEN WHICH IS EX­TREMELY COLD, ALMOST -300°F (-184 C°). EXPOSURE TO SUCH A LOW TEMPERATURE CAN CAUSE SEVERE FROSTBITE.
WARNING: LIQUID AND GASEOUS OXYGEN, THOUGH NONFLAMMA­BLE, CAUSE OTHER MATERIALS TO BURN FASTER THAN NORMAL. THIS HAZARD, ALONG WITH THE LOW TEMPERATURE OF LIQUID OXYGEN, WARRANTS CERTAIN SAFETY PRE­CAUTIONS.
WARNING: KEEP FLAMMABLE MATERIALS AWAY FROM THIS EQUIPMENT. AEROSOL SPRAYS, OILS AND GREASE, INCLUDING FACIAL CREAMS AND PETROLEUM JELLY, IGNITE EASILY AND MAY BURN RAP­IDLY IN THE PRESENCE OF OXYGEN.
WARNING: DO NOT USE OR STORE YOUR UNIT WITHIN FIVE FEET OF ELECTRICAL APPLIANCES, ESPE­CIALLY STOVES, HEATERS, TOASTERS, AND HAIR DRYERS.
PN 21033264 B | User Manual 3 - ENG
HELiOS 300 & 800
WARNING: DO NOT SMOKE WHILE OPERATING THE UNIT.
WARNING: DO NOT ALLOW SMOK­ING, CANDLES, OR OPEN FLAMES IN THE SAME ROOM WITH THE DEVICE.
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 FLAME.
WARNING: IF YOU SMOKE PLEASE: (1) TURN OFF THE HELIOS PORTABLE, (2) TAKE OFF THE CANNULA, AND (3) LEAVE THE ROOM WHERE THE DEVICE IS LOCATED.
WARNING: KEEP YOUR UNIT IN A WELL-VENTILATED AREA. DO NOT STORE LIQUID OXYGEN EQUIPMENT IN A CLOSET, CAR TRUNK, OR OTHER CONFINED AREA. DO NOT PLACE BLANKETS, DRAPERIES, OR OTHER FABRICS OVER EQUIPMENT. THIS WILL CAUSE AN OXYGEN ENRICHED ATMOSPHERE WHICH IS A FIRE HAZARD.
WARNING: DO NOT CARRY THE POR­TABLE UNIT UNDER YOUR CLOTH­ING. DO NOT STORE LIQUID OXYGEN EQUIPMENT IN A CLOSET, CAR TRUNK, OR OTHER CONFINED AREA. DO NOT PLACE BLANKETS, DRAP­ERIES, OR OTHER FABRICS OVER EQUIPMENT. THIS WILL CAUSE AN OXYGEN ENRICHED ATMOSPHERE WHICH IS A FIRE HAZARD.
WARNING: IN THE EVENT OF AN ACCIDENTAL TIP-OVER, IMMEDI­ATELY BUT CAUTIOUSLY RETURN THE UNIT INTO AN UPRIGHT POSITION IF POSSIBLE. IF ANY LIQUID OXYGEN IS ESCAPING, LEAVE THE AREA IMME­DIATELY AND CALL YOUR HEALTH­CARE PROVIDER. DO NOT ATTEMPT TO MOVE THE UNIT OR STOP THE LIQUID OXYGEN FROM ESCAPING.
WARNING: DO NOT TOUCH FROSTED PARTS OF ANY UNIT.
WARNING: DO NOT STORE OR OPERATE THE HELIOS PORTABLE COUPLED TO YOUR RESERVOIR.
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.
Caution: A caution identifies a po­tentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or damage to the equipment or other property.
Caution: RX Only. Federal law restricts this device to sale by or on the order of a physician.
Caution: Use the H300/H850 Portable only as directed by your doctor.
Caution: If the unit has been dropped, please contact your health care provider to ensure the unit is still in working condition.
Caution: Do not allow untrained personnel to handle or operate this device.
Note: Notes provide important information about using the equipment properly.
Note: Use of this device is prohibited on commercial passenger and cargo air flights by the Federal Avia­tion Administration.
Note: Applicable EMC information can be found in the Companion Portable Technical Service Manual at www.CAIREmedical.com.
4 - ENG PN 21033264 B | User Manual
HELiOS 300 & 800
Specifications
• Mode of Operation: Demand and Continu­ous Flow
• Type of Protection Against Electrical Shock: Internally Powered Equipment
Degree of Protection Against Electri-
cal Shock: Type BF Applied Part
• IPX1 Classication According to the Degree
of Protection Against Ingress of Water: Drip Proof
Equipment not suitable for use in the
presence of ammable mixtures
HELiOS Plus
(H300)
LOX capacity 0.9 lb (0,41
Gaseous equivalent capacity
Weight, filled 3.6 lb (1,63
Weight, empty 2.7 lb (1,22
Height includ­ing handle
Typical use time at 2 LPM demand mode
Typical use time at 2 LPM continuous mode
Operating pressure
Normal evapo­ration rate
Standard flow control range
kg)
308 L 685 L
kg)
kg)
10.5” (267 mm)
9 hours 22 hours
N/A 6.1 hours
22 psi (152 kPa)
1.0 lb/day (0,45 kg/day)
Continuous: off, .12, .25, .5, .75 Demand: off, 1, 1.5, 2,
2.5, 3, 3.5, 4
HELiOS
Marathon
(H850)
2.0 lb (0,91 kg)
5.6 lb (2,54 kg)
3.6 lb (1,63 kg)
15.0” (381 mm)
22 psi (152 kPa)
0.85 lb/day (0,39 kg/day)
Continuous: off, 1,2,3,4,5,6
Demand: off,
1.5, 2, 2.5, 3, 4
Introduction
A liquid oxygen system is designed to provide sup­plementary oxygen as prescribed by a physician. Your liquid oxygen system includes a HELiOS portable unit and a stationary reservoir. The res-
ervoir is the larger container that is used to ll your
HELiOS portable. This user manual contains only the instructions for using the HELiOS portable. Re­fer to the user manual supplied with your reservoir unit for information on its operation. HELiOS portable liquid oxygen units are designed to be an ambulatory source of oxygen for an
extended period of time. They are lled with liquid oxygen from a reservoir unit with a compatible ll
connector. HELiOS portables are available in two different sizes. The H300 Plus is primarily a conserving device and holds 0.38 Liters of liquid oxygen. It provides
demand (pulse) ow settings 1-4, and limited low dose continuous ow settings at 0.75 LPM and
below only. The H850 Marathon can be used as a conserving
or continuous ow device and holds 0.84 liters of liquid oxygen. It provides continuous ow from 1-6 LPM and demand ow on settings of 1-4.
H300 and H850 portable
units shown.
PN 21033264 B | User Manual 5 - ENG
HELiOS 300 & 800
Controls
1. Carrying Handle
2. Flow Control Knob
3. Dual Lumen Cannula Barbs
4. Contents Indicator Strap
5. Contents Indicator Window
6. Vent Valve Lever
7. Fill Connector (QDV)
1
2
4
3
5
6
7
Fill Connector Compatibility
The H300 and H850 can be lled from any CAIRE top-ll (TF) reservoir that has a CAIRE-style male ll connector. The compatible male and female
connections for the HELiOS portable units are shown here.
CAIRE male (reservoir) and female (H300/H850) ll connectors
6 - ENG PN 21033264 B | User Manual
HELiOS 300 & 800
Dual Lumen Cannula
In order to breathe from your H300 or H850, you must do so through a dual lumen nasal cannula. This type of cannula has two connections to the portable unit. One connection is used to detect when you inhale, and the other connection is used to deliver oxygen to your nose. A single lumen cannula cannot be used on the H300/H850. Your breath through the cannula pro-
vides the force necessary to open the ow control
valve and deliver oxygen. You must use a dual lumen cannula and inhale through your nose on
ALL ow settings to ensure that oxygen is properly
delivered.
Note: Oxygen will only be delivered through the top cannula barb.
Dual lumen nasal cannula operation: Oxygen is delivered through
top port. Breath is detected through bottom port.
Operating Instructions – Filling
1. Clean the ll connectors on the H300/H850 and
the reservoir with a clean, dry, lint-free cloth.
WARNING: THE FILL CONNEC­TORS MUST BE CLEAN AND DRY WITH A LINT-FREE CLOTH ON BOTH THE STATIONARY AND PORTABLE UNITS TO PREVENT FREEZING AND POSSIBLE EQUIPMENT FAILURE.
WARNING: DO NOT DEPRESS OR DISTURB THE POPPET ON THE FILL CONNECTOR WHEN DRYING IT. THIS CAN CAUSE LEAKAGE OF LIQUID OXYGEN.
2. Turn the ow control knob on the H300/H850 to
the off (“0”) position.
3. Hold the H300/H850 with both hands and
position its ll connector over the reservoir ll
connector.
4. Lower the portable onto the reservoir until you feel the connectors engage.
5. Place one hand on top of the H300/H850 and apply a constant downward force.
6. Open the vent valve by pulling downward on the
vent valve lever to begin the lling process. You
will hear a hissing sound that is perfectly normal.
PN 21033264 B | User Manual 7 - ENG
HELiOS 300 & 800
7. You may see vapor around the ll connection.
This is normal due to the great difference in temperature between the liquid oxygen and the warm surrounding air.
8. Maintain a downward force on the H300/H850
with one hand during the entire lling process
and keep the vent valve lever open with the other hand.
9. Approximately 20-30 seconds into the ll, close
and re-open the vent valve one or more times. This will prevent the valve from freezing open.
10. The unit is full when the hissing sound changes in tone and a dense white vapor is seen coming from under the shroud of the reservoir. When this is observed, close the vent valve by raising
the vent valve lever. This will terminate the ll.
11. Hold the handle on the H300/H850 and push the release button on the reservoir until the por­table separates (release button varies by model of reservoir).
WARNING: DO NOT LEAVE UNIT UNATTENDED WHILE FILLING.
WARNING: DO NOT OPERATE THE H300/H850 WHILE ATTACHED TO THE RESERVOIR UNIT.
WARNING: SHOULD LEAKAGE BE EXCESSIVE TO THE POINT THAT A STREAM OF LIQUID IS PRES­ENT, LEAVE THE AREA AND CALL YOUR HEALTH CARE PROVIDER IMMEDIATELY.
WARNING: IF LARGE AMOUNTS OF VAPOR ARE ISSUING FROM THE UNITS DURING FILLING, STOP FILLING, LEAVE THE ROOM AND CALL YOUR HEALTH CARE PROVIDER.
WARNING: IF PROLONGED HISSING IS HEARD, STOP USE AND CONTACT YOUR HEALTH CARE PROVIDER IMMEDIATELY
WARNING: IF THE H300/H850 DOES NOT SEPA­RATE EASILY, DO NOT USE FORCE. THE UNITS MAY BE FROZEN TOGETHER. LEAVE THE UNITS CONNECTED AND WAIT UNTIL THEY WARM UP – THEN THEY WILL SEPARATE EASILY. DO NOT TOUCH ANY FROSTED PARTS.
Caution: Should there be any liquid leakage from the portable after separating the units, , set the H300/H850 aside, ensuring it remains vertical, leave the room, and call your health care provider immediately.
Caution: Should there be any liquid leakage from the reservoir after separating the units, open windows in the room, leave the room im­mediately, and call your health care provider.
Caution: Check the liquid level only after the vent valve is closed.
Caution: If the H300/H850 is being refilled immediately after a period of use, fill it, and then wait approximately one (1) hour after fill­ing with the flow control knob set to off (“0”) for the pressure to stabilize. Then operate as normal.
12. Check the contents indicator to verify that the unit is full.
8 - ENG PN 21033264 B | User Manual
NOTE: If the HELiOS portable is warm or has not been filled recently, it may take approximately 90 seconds to fill an H300 or approximately four (4) minutes to fill an H850.
HELiOS 300 & 800
Operating Instructions – Breathing From the Portable
1. Attach both ends of a dual-lumen cannula to the connection ports on the H300/H850. Either end of the cannula may be attached to either connec­tion port on the portable.
2. Position the nasal cannula properly on your face so that you will be able to breathe comfortably.
3. Turn the ow control knob until the setting pre­scribed by your physician is fully visible in the window on top of the H300/H850.
NOTE: If the unit is on a demand (pulse) setting, you will notice a small pulse at the beginning of each inhalation. Oxygen is delivered during this pulse, and continues as long as you inhale. Oxygen flow stops when you stop inhaling.
NOTE: If the unit is in continuous flow, the H300/ H850 will deliver a steady stream of oxygen. You must continue to breathe through the nasal cannula normally to continue receiving continuous flow.
Note: Due to the possibility of excessive moisture/ ice build up it is recommended that the H300/ H850 remain idle for 1 hour after use to decrease moisture buildup.
5. You should be receiving oxygen ow now.
Verify that you feel oxygen delivery.
6. Use the duration charts available at www. CAIREmedical.com as a guideline to determine the length of time the H300/H850 will operate.
7. Under certain conditions (especially continuous use when the portable is not moved) the H300/ H850 may develop frost on the case. You may reduce this frost by wiping any accumulated frost off the case.
8. To stop the ow of oxygen, turn the ow control
knob to the off (0) position.
Caution: Always turn the flow con­trol knob off (0) when not in use.
4. Breathe normally, inhaling through your nose. Oxygen delivery will not begin until you inhale through the nasal cannula.
NOTE: Do not open the vent valve during normal operation.
NOTE: The H300/H850 may be oper­ated in an upright position, flat on its back, or any position in between these two locations.
PN 21033264 B | User Manual 9 - ENG
HELiOS 300 & 800
Operating Instructions – Level Verification
1. Lift the H300/H850 by the contents indicator strap.
2. Push the bottom backside of the unit forward until it is straight up and down.
3. Observe the green bar in the contents indica-
tor window. The window is completely lled
with the green bar when the unit is full of liquid oxygen.
Portable Full
10 - ENG PN 21033264 B | User Manual
Portable Empty
Checking the H300/H850 contents indicator
User Troubleshooting
The following information is intended to help you troubleshoot and solve simple operational problems that you may experience when using your HELiOS Portable.
1. The Portable makes a hissing sound.
• Hissing can occur to maintain the correct operating pressure within the Portable. It is
most likely to hiss after lling or when the
position of the Portable is changed. Hissing can last for approximately 10 minutes after
lling. Additionally, it can occur when the ow control valve is at a low setting.
2. The Portable does not pulse after lling.
• If during the lling process, the Portable is
disengaged with the vent valve lever down, pressure may be reduced within the Portable causing a delay in the conserving device function. It may require as much as 60 min­utes to restore adequate pressure for accurate
oxygen ow. Additionally, improper lling
or lower than normal operating pressure in the Reservoir will contribute to the unit not pulsing.
3. The Portable stops pulsing during use.
• Ensure that both connections of the dual
lumen cannula are rmly attached to the
Oxygen Outlet and Sensor connectors.
• Change the cannula if water droplets are pres-
ent from humidied exhaled gas. Replacing
the cannula with a dry one enhances the ability of the Portable to pulse.
• Ensure that the cannula is not kinked.
• Ensure that the cannula tips remain in your nostrils and do not slide to one side.
• Ensure that there is oxygen in the Portable.
• With the cannula on, close your mouth and breathe only through your nose to verify that the Portable has stopped pulsing.
4. The Portable does not ll.
• Verify that there is oxygen in the Reservoir.
• Ensure that the Portable and Reservoir ll
connectors are fully engaged throughout the
lling process.
5. The Portable vent valve does not close properly
at the end of the lling process.
• If the vent valve fails to close and the hissing sound and oxygen vapor cloud continue, carefully remove the Portable by depressing the release button on the Reservoir. Venting from the bottom of the Portable will stop in a few minutes. Allow the unit to warm until you can close the vent valve. The Portable may require as much as 60 minutes to restore
adequate pressure for accurate oxygen ow.
If needed, use an alternate source of oxygen
such as a ow control valve attached to the
Reservoir.
6. The Portable does not disengage easily from the
Reservoir after lling.
• The Portable and Reservoir ll connectors
may have become frozen. DO NOT USE FORCE. Allow a few minutes for the frozen parts to warm, then disengage the Portable when the ice has melted. To prevent the units from freezing together, always wipe the male
ll connector on the Reservoir and the female ll connector on the Portable with a clean, dry cloth before lling.
NOTE: It is recommended that routine maintenance be performed annually on this equipment. Please contact your Health Care Provider to ensure this routine maintenance is being completed.
Cleaning Standard
WARNING: DO NOT ALLOW WA­TER INTO ANY OF THE CONTROLS, THE FILL CONNECTOR, OR THE OXYGEN SUPPLY CONNECTOR.
Caution: Clean only after the unit is empty and vented.
HELiOS 300 & 800
WEEE and RoHS
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.
Transport and Storage
The device should be stored in the upright position well ventilated. Do not allow the device to be tilted forward or laying on its front. Operating tem­perature range of 14°F to 104°F (-10°C to 40°C). Storage temperature ranges from -40°F to 158°F (-40°C to 70°C).
Maintenance
Clean the ll connectors on both the stationary
and portable units with a clean, dry, lint-free cloth
between each ll to prevent freezing and possible
equipment failure.
NOTE: Any additional maintenance needed must be done by a qualified service technician or service provider.
• Clean using a solution of mild dish washing detergent and water.
• Apply cleaning solution directly to a lint-free cloth. Do not spray cleaners directly on the H300/H850.
• Wipe the outside surface with the lint-free cloth until the outside surface is clean.
Caution: Do not use high temper­ature and high pressure washing equipment to clean these units.
• Do not get cleaner on any internal compo­nents or valves.
• Allow the unit to dry thoroughly before us­ing.
Accessories
Backpack —HELiOS H850
Marathon
H850 Cart
Hip pack —HELiOS H300
PN 21033264 B | User Manual 11 - ENG
www.cairemedical.com
CAIRE Inc. 2200 Airport Industrial Dr., Ste. 500 Ball Ground, GA 30107 U.S.A.
Medical Product Service GmbH Borngasse 20 35619 Braunfels, Germany
Medstar Importacaoe Exportacao Ltda Rua Valencio Soares Rodrigues, 89, Sala 01 Centro Vargem Grande Paulista/SP Brasil 06730-00 Tel/Fax: (55)(11)5535-0989 email: medstar@medstar.com.br
Copyright © 2018 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its products,
or change the prices, materials, equipment, quality, descriptions, specications 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.
|21033264-B2~
21033264 B
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