Z1 CPAP System User manual

Human Design Medical, LLC
Z1™CPAP System
CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
User Guide
User Guide
English

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Contents
Welcome to Your Z1 CPAP System.................................................................2
Owner/User Responsibility...................................................................... 2
Replacement Z1 Parts and Supplies .............................................................2
Terms Used in this User Guide...................................................................2
Medical Information ..............................................................................3
Z1 Warnings and Cautions ........................................................................4
Battery Warnings and Cautions.................................................................... 7
Getting to Know Your Z1 CPAP System ............................................................ 8
Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Z1 CPAP Device ................................................................................. 9
Power Supply (AC to DC Power Adapter) ........................................................9
Tube Adapter ...................................................................................9
CPAP Tube ......................................................................................9
End Cap ........................................................................................9
Filter ...........................................................................................9
USB Micro Cable ...............................................................................9
PowerShell (Optional Accessory) ................................................................9
Micro SD Data Card (Not Included) .............................................................. 9
Initial Set Up .....................................................................................10
Unpacking the Z1 Box .........................................................................10
Assembling and Powering Up..................................................................11
Using Your Z1 ...................................................................................13
LCD Display....................................................................................13
Starting and Stopping Treatment ..............................................................14
Programming Ramp Mode.....................................................................15
Inserting, Removing, and Replacing the Micro SD Data Card....................................15
User Software..................................................................................16
Charging the Battery (PowerShell Only) ........................................................16
Care .............................................................................................17
Inspections ....................................................................................17
Cleaning ......................................................................................17
CPAP Tube Replacement .......................................................................18
Reminder Alert (Air Leak Detection) ............................................................18
Fault Conditions ...............................................................................19
Troubleshooting ...............................................................................19
Technical Specifications..........................................................................21
Servicing ........................................................................................22
Limited Warranty.................................................................................22
Contact Information .............................................................................22
FAA Compliance .................................................................................23
Product Registration .............................................................................25
Z1™, PowerShell™, Human Design Medical™, and the HDM logo ( ) are trademarks of Human Design Medical, LLC.
Patent Pending. © Copyright 2013, Human Design Medical, LLC. All rights reserved.
Printed in the USA.

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Welcome to Your Z1 CPAP System
Thank you for choosing the Z1 CPAP System from Human Design Medical– designed,
engineered, and assembled in the USA with you in mind.
The Z1 is specially designed with these features:
• ZBreathe™ – the Z1 automatically reduces the air pressure in the mask to relieve
pressure when you exhale and to level out the pressure differences in your natural
breathing pattern.
• Leak Compensation – the Z1 automatically compensates for minor air leakage
helping ensure the proper treatment pressure is maintained.
• Auto Altitude Adjustment – the Z1 adjusts to altitudes up to 8000 ft above sea level.
• Air Travel – The Z1 adjusts to an airplane’s cabin pressure and is approved for use on
airplanes.
• Upgradable Operating System– the Z1 firmware and software can be easily
updated via the USB Cable and your computer or by using a Micro SD Card.
This User Guide will help you take advantage of the features and capabilities of this amazing
portable CPAP device. Please read this User Guide carefully before using your Z1.
Owner/User Responsibility
The owner/user of the Z1 CPAP System is responsible for reading and understanding this User
Guide. The user is responsible for any injury or damage that results from:
• Operation of the Z1 other than in accordance with the operating instructions
contained in the User Guide supplied.
• Unauthorized maintenance or modifications to the device or attached accessories.
Replacement Z1 Parts and Supplies
Use only genuine Z1 replacement filters, parts and supplies. Replacement filters, parts and
supplies can be purchased from Human Design Medical at 1-855-436-8724 [1-855-HDMUSA4]
or online at www.hdmusa.com. Use of unauthorized filters, parts or replacement supplies can
damage the device and void the warranty.
Terms Used in this User Guide
This User Guide contains special terms and icons that appear in the text to draw your attention
to specific and important information.
WARNING alerts you to possible injury or hazard.
CAUTION explains special measures for the safe and effective use of
the device.
NOTE is an informative or helpful note.

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Medical Information
Indications for Use
Your Z1 CPAP System is a single user, reusable device that provides continuous positive airway
pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep
apnea (OSA).
Contraindications
Positive airway pressure therapy may be contraindicated in some individuals with the following
pre-existing conditions:
• Severe bullous lung disease
• Pneumothorax
• Pathologically low blood pressure
• Dehydration
• Cerebrospinal fluid leak, recent cranial surgery, or trauma.
Adverse Effects
Users should report unusual chest pain, severe headache, or increased breathlessness to
their prescribing physician. An acute upper respiratory tract infection may require temporary
discontinuation of treatment.
The following side effects may arise during the course of therapy with CPAP devices:
• Drying of the nose, mouth, or throat
• Eye irritation
• Nosebleed
• Bloating
• Skin rashes
• Ear or sinus discomfort.

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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 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 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

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Z1 and its accessories before cleaning (and clean only as instructed in this User Guide)
and make sure your Z1 and its accessories are dry before plugging back in.
• Before use, make sure the power cord and plug are in good condition and that the
cord is not damaged.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or
antibacterial soaps or scented oils to clean your Z1, Power Supply, PowerShell or
Battery. These solutions may create a shock hazard, cause damage and reduce the life
of these items.
• Explosion Hazard — Do not use or store your Z1, Power Supply, PowerShell or
Battery in the vicinity of flammable anesthetics or oxygen.
• Do not use your Z1 near toxic or harmful vapors.
• Do not drop your Z1 or any of its accessories or expose it to any crushing forces.
Should your Z1 be dropped and fail to operate properly, contact the Human Design
Medical Service Center at 1-855-436-8729 [1-855-HDMUSA9] before using the Z1 for
treatment.
• Do not insert any object into any tubing or opening of your Z1 except as described in
this User Guide.
• Do not operate your Z1 in any area which may block its air intake. Blocking the CPAP
Tube and/or air inlet of your Z1 while in operation could lead to overheating of the Z1.
• If you put the Z1 on the floor, make sure the area is free from dust and clear of
bedding, clothes or other objects that could block the air inlet or cover the Power
Supply unit.
• Only store or transport the Z1 and accessories within the storage and transport
temperature, humidity and altitude conditions specified in the Technical
Specifications section of this User Guide.
• Do not operate your Z1, Power Supply, PowerShell or Battery in an area which may
cause overheating.
• Do not cover the Power Supply, PowerShell or Battery with any object or material
which would cause them to overheat.
• Keep the power cord, Power Supply, Battery and Z1 away from hot or flammable
surfaces, gases or materials.
• Do not open your Z1 or tamper with its accessories. There are no user serviceable
parts inside. Repairs and servicing should only be performed by an authorized Human
Design Medical service agent.
• Only power the Z1 with the Human Design Medical Power Supply (AC-to-DC power
adapter, HD60-6010) or the optional Human Design Medical PowerShell with Human
Design Medical Battery. Do not use any other AC adapters, batteries, or other power
sources to power the Z1. Do not use the Human Design Medical Power Supply,
PowerShell or Battery to power any device other than the Z1.

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• Your Z1 should only be used with standard or slim style CPAP air tubing as
recommended by your physician, clinician or health care provider.
• Do not leave long lengths of air tubing around the top of your bed. The tube could
twist around your head or neck while you are sleeping.
• Do not connect or insert any device, cable or articles into the Micro USB or Micro SD
ports of your Z1 except as described in this User Guide. Connecting other devices
could result in injury to you or damage to the Z1 and void the warranty.
• Do not locate your Z1 in an unapproved place or where the air intake can be blocked
during treatment. This will lead to overheating of the Z1. If a blocked intake should
occur during operation, the unit may stop supplying pressurized air and cause a fault
condition. Refer to“Troubleshooting”in this User Guide to interpret this fault and
instructions for corrective action.
• The Z1 is designed to deliver pressures from 4 to 20 cm H2O. In the unlikely event of
certain fault conditions, pressures of up to 30 cm H2O are possible.
• Blocking the CPAP Tube while in operation could lead to overheating of the Z1.
• In the clinical environment, any personal computer that is used with your CPAP
system must be at least 5 feet (1.5 m) away from, or at least 8 feet (2.5 m) above, the
patient. It must also comply with the relevant test standard. For personal computers
the international standard is IEC 60950 or equivalent.
CAUTIONS:
• Be careful not to place your Z1 where it can be bumped or where someone is likely to
trip over the power cord.
• Make sure your Z1, Power Supply, PowerShell and Battery are kept clean, dry, and free
of dust.
• Always make sure the power cord and plugs are in good condition and the
equipment is not damaged before use.
• Make sure the area around your Z1 and accessories is dry and clean.
• During partial (below rated minimum voltage) or total power failure, therapy
pressures will not be delivered. When power is restored, your Z1 will enter standby
mode and all prior settings will be retained in memory.
• Follow the storage and cleaning instructions provided with your CPAP Tube and mask.
• The air filter should be changed at intervals specified in this User Guide.
Accumulation of filtered particles over time can reduce the efficiency and shorten the
life of any CPAP device, including the Z1. Replacement filters are available at 1-855-
436-8724 [1-855-HDMUSA4] or online at www.hdmusa.com.
• Do not wash the air filter. The air filter is not washable or reusable.
• The End Cap protects the Z1 in the event of a minor collision. Always ensure that the
End Cap is securely fitted in accordance with instructions at all times. The Z1 may not
operate if the End Cap is not properly installed.

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• The temperature of the airflow for breathing produced by CPAP devices can be higher than
the temperature of the room. This is true of all CPAP devices. Caution should be exercised
when using your Z1 at room temperatures warmer than 90˚F (32˚C).
• Only operate the Z1 and accessories within the operating temperature, humidity and
altitude conditions specified in the Technical Specifications section of this User Guide.
• Only store or transport the Z1 and accessories within the storage and transport
temperature, humidity and altitude conditions specified in the Technical Specifications
section of this User Guide.
• Damage to the CPAP Tube may result in air leaks. If this occurs, stop using the damaged
CPAP Tube and replace immediately.
Battery Warnings and Cautions
The PowerShell comes with a removable Lithium Ion Battery. Careful attention must be paid to
the warnings and cautions described below relating to the Battery. Misusing the Battery may
cause the Battery to get hot, rupture, ignite and cause serious injury.
WARNINGS:
• Do not place the Battery in fire or heat the Battery.
• Do not install the Battery backwards so that the polarity is reversed.
• Do not connect the positive terminal and the negative terminal of the Battery to each other
with any metal object (such as wire).
• Do not carry or store the Battery together with necklaces, hairpins, or other metal objects.
• Do not pierce the Battery with nails, strike the Battery with a hammer, step on the Battery or
otherwise subject it to strong impacts or shocks.
• Do not solder onto the Battery.
• Do not expose the Battery to water or salt water, or allow the Battery to get wet.
• Do not disassemble or modify the Battery. The Battery contains safety and protection
devices which, if damaged, may cause the Battery to generate heat, rupture or ignite.
• Do not place the Battery on or near fires, stoves or other high-temperature locations. Do not
place the Battery in direct sunlight, or use or store the Battery inside cars in hot weather.
Doing so may cause the Battery to generate heat, rupture or ignite. Using the Battery in this
manner may also result in a loss of performance and a shortened life expectancy.
• Immediately discontinue use of the Battery if, while using, charging or storing the Battery,
the Battery emits an unusual smell, feels hot, changes color, changes shape or appears
abnormal in any other way. Contact the Human Design Medical Service Center at 1-855-
436-8729 [1-855-HDMUSA9] if any of these problems are observed.
• Do not place the Battery in microwave ovens, high-pressure containers, or on induction
cookware.

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• In the event that the Battery leaks and the fluid gets into one’s eye, do not rub the eye. Rinse
well with water and immediately seek medical care. If left untreated the battery fluid could
cause damage to the eye.
• Only charge the Battery with the supplied Human Design Medical PowerShell and the
supplied Human Design Medical Power Supply. Do not use any other removeable battery
charger, AC adapter, or other device to charge the Battery.
• Do not attach the Battery directly to a vehicle cigarette lighter or to the Power Supply plug.
• Do not continue charging the Battery if it does not recharge within the specified charging
time. Doing so may cause the Battery to become hot, rupture or ignite.
• Remove the Battery from the PowerShell if the Z1 is not likely to be used for some time. Do
not use the Battery to power any device other than the Z1.
• Only use or charge the Battery within the operating temperature, humidity and altitude
conditions specified in the Technical Specifications section of this User Guide.
• Only store or transport the Battery within the storage and transport temperature and
humidity conditions specified in the Technical Specifications section of this User Guide.
CAUTION:
• When the Battery is worn out, insulate the terminals with adhesive tape or similar
materials before disposal.
Getting to Know Your Z1 CPAP System
Package Contents
Human Design Z1 Base Z1
Description Medical Part # Model Unplugged
Z1 CPAP Device HD60-1000 
Power Supply & Cord HD60-6010 
USB A to Micro B Cable HD60-6300 
CPAP Tube Adapter HD60-5020 
48” Slim Style CPAP Tube HD60-2010 
End Cap HD60-5011 
Filter HD60-3020 
Z1 Getting Started Guide HD40-0005 
User Guide HD40-0007 
Overnight Battery HD60-7050 
Battery Shuttle HD60-7030 
PowerShell HD60-7020 
PowerShell Getting Started Guide HD40-0012 