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
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 Classication According to the Degree
of Protection Against Ingress of Water: Drip
Proof
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 humidied 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
or change the prices, materials, equipment, quality, descriptions, specications 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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