Intended Use; Contraindications For Use; Safety Guidelines - CAIRE Eclipse 5 Manual Del Usuario

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 Eclipse 5.
Note: Information needing special attention.
Indications for Use

Intended Use

The CAIRE Eclipse 5 Oxygen Concentrator is
intended for the administration of supplemental ox-
ygen. The device is not intended for life support nor
does it provide any patient monitoring capabilities.
WARNING: IT IS VERY IMPORTANT
TO SELECT ONLY THE PRESCRIBED
LEVEL OF OXYGEN. DO NOT CHANGE
THE FLOW SELECTION UNLESS YOU
HAVE BEEN DIRECTED TO DO SO BY A
LICENSED CLINICIAN. THE PORTABLE
OXYGEN CONCENTRATOR MAY BE
USED DURING SLEEP UNDER THE
RECOMMENDATION OF A QUALIFIED
CLINICIAN.
WARNING: TO ENSURE RECEIVING THE
THERAPEUTIC AMOUNT OF OXYGEN DELIVERY
ACCORDING TO YOUR MEDICAL CONDITION,
ECLIPSE 5 MUST BE USED ONLY AFTER ONE OR
MORE SETTINGS HAVE BEEN INDIVIDUALLY
DETERMINED OR PRESCRIBED FOR YOU AT YOUR
SPECIFIC ACTIVITY LEVELS. ECLIPSE 5 MUST BE
USED WITH THE SPECIFIC COMBINATION OR
PARTS AND ACCESSORIES THAT ARE IN LINE
WITH THE SPECIFICATION OF THE CONCENTRA-
TOR MANUFACTURER AND THAT WERE USED
WHILE YOUR SETTINGS WERE DETERMINED.
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 PATIENT UNABLE TO COMMUNICATE
DISCOMFORT CAN REQUIRE ADDITIONAL
MONITORING AND/OR A DISTRIBUTED ALARM
SYSTEM TO CONVEY THE INFORMATION ABOUT
THE DISCOMFORT AND OR THE MEDICAL
URGENCY TO THE RESPONSIBLE CARE GIVER TO
AVOID HARM. PATIENTS WITH HEARING AND/OR
SIGHT IMPAIRMENT(S) MAY NEED ASSISTANCE
WITH MONITORING ALARMS.

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 Eclipse 5 SERVICED BY A
QUALIFIED TECHNICIAN. THE Eclipse 5 IS NOT
APPROPRIATE FOR ANY PATIENT WHO WOULD
EXPERIENCE ADVERSE HEALTH CONSEQUENCES
AS THE RESULT OF SUCH TEMPORARY INTER-
RUPTION.

Safety Guidelines

WARNING: NO MODIFICATION OF
THIS EQUIPMENT IS PERMITTED
WARNING: 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.
WARNING: THIS DEVICE SUPPLIES HIGH-CON-
CENTRATION OXYGEN THAT PROMOTES RAPID
BURNING. DO NOT ALLOW SMOKING OR OPEN
FLAMES WITHIN TWO (2) METERS 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 OPERATE UNIT IN A RE-
STRICTED OR CONFINED SPACE (I.E., A SMALL
CASE OR HANDBAG) WHERE VENTILATION CAN
BE LIMITED. THIS CAN CAUSE THE OXYGEN
CONCENTRATOR TO OVERHEAT AND IMPAIR
PERFORMANCE.
PN 21182453-C4 E | User Manual
Eclipse 5
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