Guidance And Manufacturer's Declaration - Human Design Medical Z1 CPAP System User Manual

Treatment Will Not Start
Insufficient Air Flow Delivered from Z1
Pressure Rises Inappropriately
Mask Cushion is Vibrating Against the Skin
and an Air Leak is Occurring
Z1 Has Been Left in a Hot Environment
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A power supply not designed for the Z1 is
connected to the Z1 . Remove the power supply
unit and replace with a Human Design Medical
approved unit .
Check the display for a fault condition . Refer
to the Fault Codes table in "Fault Conditions" .
Contact the Human Design Medical Service
Center at 1-855-436-8724
Air filter is dirty or clogged . Replace air filter .
Air intake is blocked . Clear blockage .
CPAP Tube is not connected properly . Check
CPAP Tube, Tube Adapter and connections to
your Z1 and your mask .
Ramp Mode is in use . Wait for air pressure to
reach prescribed treatment pressure or stop
treatment and adjust ramp time .
CPAP Tube is blocked, pinched or punctured .
Unblock CPAP Tube. Check the CPAP Tube for
punctures . Replace a damaged CPAP Tube
immediately .
Mask and/or headgear are not positioned
correctly and mask is leaking . Adjust position of
the mask and headgear until leak ceases .
Incorrect CPAP Tube selected . Do not use tubing
which was not recommended by your clinician .
Check the display for a fault condition . Refer to
fault codes in "Fault Conditions" .
Talking, coughing or breathing in an unusual
manner . For example, avoid talking with a nasal
mask on and breathe as normally as possible .
There may be an air leak caused by improperly
connected tubing . Check for leaks .
Follow mask manufacturer's instructions .
Stop treatment . Remove and reposition the
mask and, if necessary, adjust the headgear .
Resume treatment .
Follow mask manufacturer's instructions .
Allow Z1 to cool before use . Disconnect the
power cord and then reconnect it to restart the
Z1 .
Electromagnetic Compatibility

Guidance and Manufacturer's Declaration

Electromagnetic Emissions & Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to EMC information provided in this document .
The Z1 System does not have Essential Performance within the meaning of IEC 60601-1 . However,
immunity testing was conducted in accordance with IEC 60601-1-2 and compliance was
confirmed as summarized in this document .
Guidance and manufacturer's declaration - electromagnetic emissions
The Z1 CPAP System is intended for use in the electromagnetic environment specified below . The
customer or the user of the Z1 System should assure that it is used in such an environment .
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
WARNINGS:
• The device should not be used adjacent to or stacked with other equipment . If
adjacent or stacked use is necessary, the device should be observed to verify normal
operation in the configuration in which it will be used .
• The use of cables and accessories (eg, humidifiers) other than those specified for the
device is not recommended . They may result in increased emissions or decreased
immunity of the device .
The Z1 and PowerShell meet all applicable
electromagnetic compatibility standards .
However, if you suspect performance of the
device is affected by interference from wireless
sources, move the Z1 and PowerShell further
away from those sources .
Electromagnetic environment — guidance
The Z1 CPAP System uses RF energy only for its
internal function . Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment .
The Z1 CPAP System is suitable for use in all
establishments, including domestic establish-
ments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes .
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