Z1 Warnings And Cautions - Human Design Medical Z1 Auto System User Manual

Z1 Warnings and Cautions

WARNINGS:
• Read the entire User Guide before using your Z1 . Consult your healthcare 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 healthcare 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 healthcare
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 off, insufficient 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 suffocation . This applies to most CPAP
devices . Your healthcare 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
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