Intended Use; User Profile; Service Life - Invacare IOH2M6 User Manual

1.2 Intended Use

This cylinder assembly is intended to store, regulate, and deliver
supplemental oxygen to patients who may have difficulty extracting
oxygen from the air they breathe. It is for patients who would
normally receive the oxygen via a nasal cannula. This device delivers
USP 93±3% oxygen at a number of different flow settings and may
increase the drying out of airways. This product is to be used as
an oxygen supplement and is not intended to be life supporting or
life sustaining.
DANGER!
Risk of Injury or Death
This product is to be used as an oxygen supplement and
is not intended to be life-supporting or life-sustaining.
ONLY use this product if the patient is capable of
spontaneous breath, able to inhale and exhale without
the use of a machine.
WARNING!
Risk of Injury or Damage
Use of this product outside of the intended use and
specifications has not been tested and may lead to
product damage, loss of product function, or personal
injury.
– DO NOT use this product in any way other than
described in the specifications and intended use
sections of this manual.

1.3 User Profile

No specific product knowledge or training is required, other than
what is contained in this manual, to operate the product. It is not
intended for supplying oxygen therapy during refilling. This product is
1193304-A-00
intended to be used by or under adult supervision only after reading
and understanding the instructions and warnings of this user manual.
Only personnel instructed and trained in the use of the HomeFill®
cylinder assembly should operate this product.
The use of this product is limited to the oxygen patient. Cylinder
assemblies MUST be used only by the oxygen patient and are not to
be distributed to any other individual for any purpose.
This product is NOT to be used by patients who breathe through
their mouths.

1.4 Service Life

WARNING!
Risk of Injury or Damage
The product has been tested for the service life stated in
this manual. Use of the product beyond this time period
may cause injury or product damage.
– ONLY use the product for the service life stated in
this manual. DO NOT exceed the service life of the
product.
– Perform all maintenance according to the
recommended schedule in this manual.
The expected service life of the regulator is five years when used in
accordance with the safety instructions, maintenance intervals and
correct use stated in this manual. Refer to the Maintenance section.
The expected service life of the cylinder is based on testing the
cylinder every five years and using it in accordance with the safety
instructions, maintenance intervals and correct use stated in this
manual. Refer to the following procedures:
•
The Hydrostatic Testing Date, External Examination,
Maintenance
General
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