Human Design Medical Z1 Auto System User manual

AN AFFILIATE OF BREAS MEDICAL AB
Human Design Medical, LLC
Z1 Auto™System
AUTO-ADJUSTING CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
User Guide
User Guide
English
AN AFFILIATE OF BREAS MEDICAL AB
Human Design Medical, LLC
Charlottesville, VA 22902
Z1 Auto User Guide v1 11102014
#40-0028 Rev. A
www.TheCPAPShop. com
866-414-9700

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Contents
Welcome to Your Z1 Auto System ..............................................................2
Owner/User Responsibility ...................................................................2
Healthcare Provider Responsibility............................................................2
Replacement Parts and Supplies .............................................................2
Terms Used in this User Guide ................................................................3
Medical Information ...........................................................................3
Z1 Warnings and Cautions .....................................................................4
Battery Warnings and Cautions .................................................................7
Getting to Know Your Z1 Auto System..........................................................8
Package Contents............................................................................8
Z1 Auto 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
Initial Set Up ..................................................................................10
Unpacking the Z1 Auto Box .................................................................10
Assembling and Powering Up ...............................................................11
Using Your Z1 Auto ...........................................................................13
LCD Display .................................................................................13
Function Modes.............................................................................14
Starting and Stopping Treatment............................................................15
Choosing Between Z-Breathe Settings.......................................................15
Programming Ramp Mode .....................................................…………….16
Z1 Auto Bluetooth Connectivity .............................................................17
Z1 Auto NiteLog Bluetooth App .............................................................17
Z1 User Software............................................................................17
Charging the Battery (PowerShell Only)......................................................17
Care ..........................................................................................18
Inspections .................................................................................18
Cleaning ...................................................................................18
Reminder Alert (Air Leak Detection) ...........................................................19
Fault Conditions ..............................................................................20
USB Firmware Upgrade. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Troubleshooting ..............................................................................20
Guidance and Manufacturer’s Declaration .....................................................22
Technical Specifications .......................................................................26
Servicing......................................................................................28
Limited Warranty..............................................................................28
Contact Information ..........................................................................28
FAA Compliance ..............................................................................29
Product Registration ..........................................................................31
Z1 Auto™, Z1 Unplugged™, and NiteLog™ are trademarks of Human Design Medical, LLC. The HDM logo ( ), Z1®,
PowerShell® and Z-Breathe® are registered trademarks of Human Design Medical, LLC. Breas is a registered trademark
of Breas Medical AB. All other trademarks are the property of their respective owners.
Patent Pending. © Copyright 2014, Human Design Medical, LLC. All rights reserved.
Printed in the USA.

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Welcome to Your Z1 Auto System
Thank you for choosing the Z1 Auto System from Human Design Medical– designed and
engineered in the USA with you in mind.
The Z1 is specially designed with these features:
• Z-Breathe®–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.
This User Guide will help you take advantage of the features and capabilities of this amazing
portable,auto-adjustingCPAPdevice.PleasereadthisUserGuidecarefullybeforeusingyourZ1.
Owner/User Responsibility
The owner/user of the Z1 Auto 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modicationstothedeviceorattachedaccessories.
Healthcare Provider Responsibility
Your healthcare provider is responsible for explaining contraindications and instructions for use to
the patients/users.
Replacement 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.

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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.
Medical Information
Indications for Use
Your Z1 Auto System is a single patient, 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uid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 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owofairoutofthemask.WhenyourZ1 is turned on
and functioning properly, new air from the Z1ushes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,
conrmthatairisowing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ammable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oor,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ammable
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 healthcare 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Z1 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ltershouldbechangedatintervalsspecied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lter.Theairlter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airow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uidgetsintoone’seye,donotrubtheeye.Rinse
wellwithwaterandimmediatelyseekmedicalcare.Ifleftuntreatedthebatteryuid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 Auto System
Package Contents
Z1 Auto Base Model
Z1 Auto CPAP Device
Power Supply & Cord
Custom USB A to Micro B Cable
Custom CPAP Tube Adapter
48” Slim Style CPAP Tube
End Cap
Filter (2- 1 installed in Z1, 1 in box)
Heat / Moisture Exchanger (HME)
Z1 Auto Getting Started Guide
Z1 Auto User Guide
PowerShell Module
Overnight Battery
Battery Shuttle
PowerShell
PowerShell Getting Started Guide
The Z1 Auto Unplugged contains both the Z1 Auto Base Model and the PowerShell Module.

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Z1 Auto CPAP Device
The Z1 supplies continuous positive airway pressure and can be programmed to fit the patient’s
prescriptive needs.
Power Supply (AC to DC Power Adapter)
The Power Supply provides power to the Z1. It takes AC power (voltage ranging from 100-240
volts) from a wall outlet and converts it to DC voltage to power the Z1. The Power Supply can be
used with international power sources provided the appropriate plug adapter is used.
Tube Adapter
The Tube Adapter attaches the CPAP Tube to the Z1.
CPAP Tube
The Z1 System is provided with a 4 ft slim style CPAP Tube. The CPAP Tube connects the Z1 to your
mask. Always consult with your physician or healthcare provider regarding the selection of tubing
for your treatment. Follow the instructions provided with the tubing. Replacement tubing can be
purchased from Human Design Medical at 1-855-436-8724 [1-855-HDMUSA4] or online at www.
hdmusa.com.
End Cap
The End Cap attaches to the air intake end of the Z1 and houses the Filter.
Filter
The Z1 uses a specially designed filter. The material has been specifically chosen for the Z1 and
has been designed to be much larger than other CPAP filters. The unique shape of the lter fits
into the End Cap of the Z1, which was designed to allow for more effective filter surface area.
For proper operation of the Z1, the Filter should be replaced monthly or more often if necessary.
USB Micro Cable
The USB Cable allows the Z1 to communicate with a computer to collect and view user data.
PowerShell (Optional Accessory)
The PowerShell houses both the Z1 and the Battery which allows temporary usage of the Z1
without the Power Supply. It can be purchased at 1-855-436-8724 [1-855-HDMUSA4] or online at
www.hdmusa.com.
NOTE: Replacement parts, supplies and accessories can be purchased from
Human Design Medical at 1-855-436-8724 [1-855-HDMUSA4] or online at
www.hdmusa.com.