4
Z1 Warnings and Cautions
WARNINGS:
• Read the entire User Guide before using your
Z1
. Consult your health care provider if
there is any part of this User Guide you do not understand.
• US Federal law restricts this device to sale by or on the order of a physician.
• Use your
Z1
and its accessories only for their intended use as described in this User
Guide and as directed by your physician, clinician or health care provider.
• The
Z1
is not approved for use with oxygen. Do not use supplemental oxygen or
any other type of supplementary gas with your
Z1
. Do not connect supplementary
oxygen or other gas to any accessory or patient interface which is connected to your
Z1
.
• If you notice any unexplained changes in the performance of your
Z1
or your
Z1
is making unusual or harsh sounds, or if the
Z1
or
Power Supply
are dropped or
mishandled, discontinue use and contact the Human Design Medical Service Center
at 1-855-436-8729 [1-855-HDMUSA9].
• If your
Z1
,
Power Supply, PowerShell
or
Battery
is dropped or mishandled, or if water is
spilled into an enclosure, or if an enclosure is broken, discontinue use and contact the
Human Design Medical Service Center at 1-855-436-8729 [1-855-HDMUSA9].
• A mask is not provided. Your
Z1
should only be used with masks and connectors
recommended by your physician, clinician, respiratory therapist or health care
provider.
• Your
Z1
is intended to be used with CPAP masks (or connectors) which have vent
holes to allow continuous flow of air out of the mask. When your
Z1
is turned on
and functioning properly, new air from the
Z1
flushes the exhaled air out through
the mask vent holes. However, when the
Z1
is not operating properly (e.g., at low
pressure) or the
Z1
is o
ff
, insu
ffi
cient fresh air may be provided through the mask and
the exhaled air may be rebreathed. Rebreathing exhaled air for longer than several
minutes can, in some circumstances, lead to su
ff
ocation. This applies to most CPAP
devices. Your health care provider will recommend a mask and air tubing to suit
your needs. The
Z1
supports several CPAP mask types including nasal masks, full face
masks, and nasal prongs that meet the ISO 17510-2 standard.
• Do not use your
Z1
with a mask unless the
Z1
is turned on. Once the mask is fitted,
confirm that air is flowing from your
Z1
.
• Do not block the vent hole or holes in the mask. Follow the mask manufacturer’s
instructions for proper use of the mask.
• In the event of a power failure or machine malfunction, remove the mask
immediately.
• At low pressures some exhaled gases may remain in the mask.
•
Electrocution Hazard
– Your
Z1
is an electrical device, and as such, you should not
immerse your
Z1
,
Power Supply, PowerShell
or
Battery
in water. Always unplug your
