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
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