Z1 User Guide w tube changes-page move.indd
Contents
1. 3 The Z7 will power up and cycle through a series of startup displays Figure 8 4 After about 10 seconds the Z1 will enter standby mode The display will read 0 0 Figure 8 NOTE Remove the Battery from the PowerShell when the Z7 is not in use unless the Power Supply is plugged into the PowerShell to charge the Battery Otherwise the Z1 and PowerShell will drain the battery completely within 2 3 days Using Your Z1 LCD Display Treatment Pressure Display The current treatment pressure is shown on the LCD display Once set the prescribed treatment pressure will be retained in the Z7 s memory even during loss of power For example a treatment pressure setting of 10 0 cm H O is displayed in Figure 9 Ramp Progress amp Ramp Time Remaining Indicators Ramp Mode allows you to gradually acclimate to the prescribed treatment pressure Ramp Mode gradually increases the pressure from a low initial starting pressure to the prescribed treatment pressure over a programmed interval of time See Programming Ramp Mode If you program the Z1 for Ramp Mode the Ramp Progress and Ramp Time Remaining indicators will appear on the LCD display For example Figure 9 indicates that the ramp is just over half complete with a ramp time remaining of 10 minutes Current Date Q Battery Status Display PowerShell Only Ramp Progress o O AC Power Indicator 9 Ramp Time Remaining Fault o Treatment Pressure2. 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 ZT 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 n 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 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 moisturiz
3. Inappropriately Mask Cushion is Vibrating Against the Skin and an Air Leak is Occurring Z1 Has Been Left in a Hot Environment 20 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 8729 1 855 HDMUSA9 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 reatment 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 ask and or headgear are not positioned correctly and mask is leaking Adjust position of he mask and headgear until leak ceases ncorrect 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 Resum
4. LIMITATION MAY NOT APPLY TO YOU BLE FOR ANY INCIDENTAL OR ULTED FROM THE SALE INSTALLATION OR OME REGIONS OR STATES DO NOT ALLOW CONSEQUENTIAL DAMAGES SO THE This warranty gives you specific legal rights and you may also have other rights which vary from region to region For further information on your warr anty rights contact your local Human Design Medical dealer or Human Design Medical office at 1 855 436 8729 Contact Information Human Design Medical LLC 119 Braintree Street Suite 703 Boston MA 02134 www hdmusa com ain phone Supplies amp replacement parts Service support or warranty coverage Email General HUMAN DESIGN MEDICAL E HDM 1 855 436 8724 1 855 HDMUSA4 1 855 436 8729 1 855 HDMUSA9 service support hdmusa com info hdmusa com If you are planning on using your Z1 on an airplane please detach this letter and carry it with you E HDM HUMAN DESIGN MEDICAL FAA Compliance To whom it may concern The US Department of Transportation DOT Final Rule Nondiscrimination on the Basis of Disability in Air Travel 73 FR 27614 which updates Title 14 CFR Part 382 effective May 13 2009 provides important requirements for the accomodation of passengers with respiratory assistive devices Ventilators Respirators and CPAP machines In line with these requirements respiratory assistive devices may be used onboard an
5. Slot slight click Figure 12 4 Plug in the Z1 Power Supply Occasionally you may be asked to remove the Micro SD Card and send it to your clinician The card will contain information collected about treatment Follow the instructions provided below before you attempt to remove or replace the card To remove and replace the Micro SD Card 1 Unplug power to the Z1 2 To remove Micro SD Card gently push the Micro SD Card in toward the Z1 and release The Micro SD Card will pop out from the device Grasp the Micro SD Card gently and pull completely out of the Z1 3 Plug in the Z1 Power Supply NOTE The Z1 maintains at least 30 days of treatment history in memory and will update the Micro SD Card when inserted User Software See separate Z1 Software Guide for information on data viewing software This guide may only be available online Charging the Battery PowerShell Only A WARNING Only charge the Battery with the supplied Human Design Medical PowerShell and the supplied Human Design Medical Power Supply Do not use any other battery charger AC adapter or other device to charge the Battery With both the Z1 and the Battery fully inserted into the PowerShell plug the Power Supply into the PowerShell as shown and into a power outlet Figure 13 CAUTION Make sure your Battery is fully charged before commencing CPAP therapy using the PowerShell The battery life of Ww a fully charged
6. seconds to save your ramp time setting this setting will be saved even when the Z7 is not powered The Z7 will return to standby mode To return to standby mode without saving the new setting press and release the Start Stop Button momentarily instead of holding it down Figure 11 Setting Ramp Start Pressure Press and hold the Down Arrow Button for 3 seconds until the ramp start pressure value flashes While flashing repeatedly press either the Up or Down Arrow Buttons to increase or decrease the ramp start pressure by 0 5 cm H20 increment Figure 11 Ramp start pressure must be lower than prescribed pressure When the desired value for ramp start pressure is reached hold down the Start Stop Button for approximately 3 seconds to save your setting The Z1 will return to standby mode To return to standby mode without saving the new setting press the Start Stop Button momentarily instead of holding it down Inserting Removing and Replacing the Micro SD Data Card Optional If your clinician instructs you to use a Micro SD Card please insert a Micro SD Card with a minimum capacity of 2 GB following the instructions below Micro SD Cards are available at electronics stores To insert the Micro SD Card 1 Unplug power to the ZT 2 Orient the card so that the printed side is up and the angled corner is pointing into the slot 3 Carefully slide the card all the way into the slot Figure 12 You should feel a Card
7. 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 ZT 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 maskis 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
8. 1042013 E HDM HUMAN DESIGN MEDICAL Human Design Medical LLC 119 Braintree Street Suite 703 Boston MA 02134 Z1 User Guide v1 11012013 140 0007 Rev A
9. 238 9 Flame retardant engineered thermoplastic Not for use with oxygen Polyester The 22 mm air outlet complies with ISO 5356 1 45 Watt hours capacity Lithium lon Battery Pack 4S1P Weight approx 8 oz The following symbols may appear on your device power supply unit or packaging A Caution li BF equipment Ol Class Il equipment Start stop ud Manufacturer Batch codes REF catalog number SN serial number Direct current KS Not for use on more than one patient Z amp Product disposal warning to EN50419 RX ONLY Prescription only In US Federal law restricts these device to sale by or on order of a physician 21 22 Servicing The Z1 System is intended to provide safe and reliable operation when operated in accordance with the instructions provided by Human Design Medical Human Design Medical recommends that the Z1 System be inspected and serviced by an a uthorized Human Design Medical Service Center if there is any sign of wear or concern with Z1 function Otherwise service of the Z1 generally should not be required during the warranty the device Limited Warranty period see Limited Warranty for details of Human Design Medical warrants that your Human Design Medical product shall be free from defects in material and workmanship from the date of purchase for the period specified below Component Warranty Period Z1 device 3 years PowerShell 2 years Overnight Battery 9 months P
10. Design Medical for the Z1 The Z1 is designed to only work with approved materials A filter which is not approved may cause damage to the Z1 from overheating CAUTION Do not operate the Z1 without the Filter The Z1 must operate with a filter installed failure to do so may damage the Z1 and allow impurities into the respiratory system CPAP Tube Replacement The CPAP Tube should be replaced according to the instructions provided with the CPAP Tube Reminder Alert Air Leak Detection REMINDER is displayed on the LCD screen to indicate an excessive air leak This could be because you are not wearing your mask Placing the mask on your face should remove REMINDER from the display If you are wearing the mask and REMINDER is displayed check the following connections for air leaks Tube Adapter to Z1 CPAP Tube to Tube Adapter CPAP Tube to mask Mask to face adjust position of mask and headgear to eliminate the air leak Fault Conditions The ZT has the ability to detect operational problems and will display the word FAULT on the LCD screen Figure 15 The LCD screen should be checked for any FAULT messages and visible damage daily A fault condition is indicated when the word FAULT is displayed accompanied by a two digit flashing number in place of the pressure reading Figure 15 The table below provides a listing of fault codes and recommended actions to be taken by the user Fault Code Ex
11. Display Reminder Q Figure 9 Battery Status Display This icon is displayed when the optional PowerShell and Battery are connected The level of charge remaining on the Battery is indicated by the number of solid bars in the icon The bars flash when the Battery is charging Fo Battery has between 25 50 of charg each use Number of Solid 1 5 3 4 O AC Power Indicator O Current Date The current date is displayed automat O FAULT r example the icon shown in Figure 9 indicates that the e remaining Make sure the Battery is fully charged before Bars Charge Remaining 10 25 25 50 50 75 75 100 This icon is displayed when the Z1 is connected to an AC power outlet via the Power Supply ically on the Z7 It is pre programmed at the factory FAULT is displayed if one of several conditions has occurred that require your attention See Fault Conditions page 19 for explanations REMINDER of the FAULT codes REMINDER is displayed if there is excessive air leakage See Reminder Alert page 18 for an explanations of REMINDER conditions Starting and Stopping Treatment 1 Press the Start Stop Button on the ZT to initiate treatment using the pre programmed prescription setting The Treatment Pressure Display will show the actual pressure being delivered at all times If the pressure will be displayed upon p pressure will rise as the Z7 ramps pressure is displayed contact you therap
12. LC RAR SUE CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM User Guide Human Design Medical LLC E HDM HUMAN DESIGN MEDICAL User Guide English Contents Welcome to Your Z1 CPAP System 00 cece ccc cece eee ee eee ee e ee ees ens 2 OWwner USErRESPOMSIDINYs ii nee 2 Replacement Z1 Parts and SUPplieS o oooooocccoooccccccccccnorconnrrn rre e 2 Terms Used irthis User Guide aia nenn UR heine 2 Medical Information 6 cece cece eee eee e eee 3 ZA Wamingsand Cautions score ete ure ee bor ege ted NR een 4 Battery Warnings and Cautions cess encor nahen a 7 Getting to Know Your Zi CPAP SYSTEM ici era angehen 8 Package Contents as en dee ihren 8 ZIFGPAP DEVICE O 9 Power Supply AC to DC Power Adapter 6 0 cc ccc ccce seen nese ee eeeeenenteeeeeeeanenes 9 Tube Adapter nun nasser ie 9 AU ne A een er a HM 9 BAG Capt ren sand ER keiner 9 Filter IP e Lore ken ne 9 USB Micro Cable una a as 9 PowerShell Optional Accessory ooooooooocconocnoccroo reno e mes enn 9 icro SD Data Card Not Included ooooocccccccoccccncoccnc m ee 9 Initial ser DEus ese be EE Mon TREE en waa ate metam oe nee 0 Unpacking the Z T BOX ae don e s rr vest ti 0 Assembling and Powering Up see erre hee RR terere a derer ga 1 Using YoUr ZT aussen tner 3 LCD DISplayz sas epe nee ei 3 Starting and Stopping Treatment 25 4 vena e bU ERN PESE e ege 4 Programming Ramp Mode ame OE OB eher
13. aircraft without further testing by the carrier provided they have been tested for Electromagnetic Compatibility EMC in accordance with the current version of RTCA DO 160 Section 21 Category M Human Design Medical has successfully completed testing for the Z1 CPAP System The Z1 CPAP System complies with RTCA DO 160 Section 21 Category M and can be considered FAA compliant Some airlines may require advance notification before travel and devices may need to be operated by battery Human Design Medical recommends that customers check with their airline Human Design Medical LLC 119 Braintree Street Suite 703 Boston MA 02134 1 855 436 8724 HD HUMAN DESIGN MEDICAL Mail completed form to HDM Product Registration 200 Garrett St Suite P Charlottesville VA 22902 Register your new device Registering your device allows us to provide better customer service and warranty coverage Please register as soon as possible NAME First MI Last EMAIL ADDRESS MAILING ADDRESS Street or PO Box City State Zip PHONE NUMBER About the device WHAT DEVICE DID YOU PURCHASE WHERE DID YOU PURCHASE THE DEVICE PURCHASE DATE IL MM DD YY Z1 SERIAL NUMBER POWERSHELL SERIAL NUMBER The device serial number can be found on the back of the unit Look for the string of numbers following SN 1
14. 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 ZT 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 operati
15. battery in the PowerShell is typically 8 hours or longer after which treatment will terminate To recharge the Battery see Charging the Battery Ensure the ZT is in standby mode display reads 0 0 The Battery will not charge unless the Z1 is in standby mode The Battery status indicator on the Z1 will flash when the Battery is charging The number of solid bars indicates the current level of charge Figure 14 Figure 14 Care The Z1 System needs periodic care It is the user s responsibility to be aware of the following items for care Inspections Cleaning Filter Replacement CPAP Tube Replacement Reminders and Fault Conditions Inspections Before each use carefully inspect the Z7 CPAP Tube Filter and mask for signs of wear damage or discoloration Contact Human Design Medical for replacement parts at 1 855 436 8724 1 855 HDMUSA4 or online at www hdmusa com Cleaning Regular cleaning should be performed in accordance with the instructions below ZA WARNING This device can expose you to electrocution Do not immerse the Z1 Power Adapter Power Cord or Battery in water Always unplug these devices before cleaning only as instructed in this User Guide and make sure they are dry before plugging back in CAUTION Do not use bleach chlorine alcohol or aromatic based solutions moisturizing or antibacterial soaps or scented oils to clean the Z1 Never attempt to clean the Power A
16. dapter PowerShell Battery or accessories with any of these solutions These solutions may create a shock hazard cause damage and reduce the life of these products Daily 1 Remove the CPAP Tube and the mask from the Z7 2 Refer to the instructions for cleaning maintenance and replacement provided with your CPAP Tube and mask 3 Before next use reconnect the CPAP Tube and the Tube Adapter to the Z1 and mask Weekly 1 Remove the CPAP Tube Tube Adapter and mask from the Z7 Wash the Tube Adapter in warm water using a mild detergent Rinse thoroughly and allow to dry Refer to the manufacturer s instructions for cleaning the CPAP Tube and mask 2 Before next use reconnect the CPAP Tube to the Tube Adapter and then to the Z7 and mask As Needed 1 Clean the exterior of the Z1 with a soft damp cloth and mild detergent and wipe Clean Never submerge the Z1 in water Do not allow soap or water to enter the Z1 Filter Replacement The Filter should be inspected weekly for holes and blockage by dirt and dust and should be replaced every month or more often if necessary The Filter is accessed by removing the End Cap as described in Assembling and Powering Up Filter and End Cap NOTE The Z1 uses a specially designed Filter that is only available from Human Design Medical at 1 855 436 8724 1 855 HDMUSA4 or online at www hdmusa com AN WARNING Do not attempt to use any air filter which is not supplied by Human
17. e AC power cord into the AC Adapter 2 Plug the AC power cord into a wall outlet 3 Plug the AC Adapter into the Z1 Figure 4 4 The Z1 will power up and cycle through a series of startup displays 5 After about 10 seconds the Z1 will enter standby mode The display will read 0 0 Figure 5 NOTE The Z1 display will be active whenever the device is receiving power PowerShell and Battery Available Separately or as Part of Z1 Unplugged A WARNING The Z1 must only be used with the optional Human Design Medical PowerShell with Human Design Medical Battery or the Human Design Medical Power Supply DO NOT use any other power source with the ZT 1 Slide the Battery with the attached Shuttle into the lower bay of the PowerShell until the Shuttle clicks into place Figure 6 NOTE The Battery can be removed from the PowerShell by pressing the two blue buttons on the Battery Shuttle and sliding the Battery out 2 Slide the Z1 all the way into the upper bay of the PowerShell until you hear a click sound indicating the Z1 has locked into place Figure 7 CAUTION Insert the Z1 carefully ensuring the power barrel connector slides into the power input on the Z1 Figure 4 Figure 5 g on Figure 6 Figure yi NOTE The Z1 can be removed from the PowerShell by pressing the two symbols on the sides of the PowerShell and sliding the Z1 out
18. e 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 For proper operation of the Z1 the Filter should be replaced monthly or more often if necessary 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 filter fits into the End Cap of the Z1 which was designed to allow for more effective filter surface area NOTE Replacement Filters can be purchased from Human Design Medical at 1 855 436 8724 1 855 HDMUSAA or online at www hdmusa com 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 HDMUSAA or online at www hdmusa com Micro SD Data Card Not Included Your clinician might instruct you to provide data via a Micro SD card for monitoring of your treatment or to provide you with updates to your device settings See Inserting Removing and Replacing the Micro SD Data Card for complete information on use of a Micro SD Card Initial Set Up Unpac
19. e 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 A 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 mmediately discontinue use of the Battery if while using charging or storing the Battery the Battery emits an unusual smell fee
20. e treatment Follow mask manufacturer s instructions Allow Z1 to cool before use Disconnect the power cord and then reconnect it to restart the Zil Technical Specifications 30W Power Adapter Operating temperature Operating humidity Operating altitude Operating atmospheric pressure Storage and transport temperature Storage and transport humidity Storage and transport altitude Storage and transport atm pressure Electromagnetic compatibility Aircraft use EC 60601 1 classification Available modes Operating pressure range aximum single fault steady pressure state Deliverable pressure accuracies Sound pressure level ominal dimensions L x W x H Weight Housing construction Supplemental oxygen Standard air filter Air outlet PowerShell Battery Specifications Part HD60 6010 Unit Input range 100 240V 50 60Hz Typical power consumption 20W 30VA Maximum power consumption 35W 70VA 41 F to 95 F 5 C to 35 C 0 80 Relative Humidity Non Condensing Sea level to 8 000 ft 2 591 m 01 to 75 3 kPA 4 F to 140 F 20 C to 60 C 0 80 Relative Humidity Non Condensing o limit o limit Compatible with IEC 60601 1 2 Complies with RTCA DO 160G Standard for use in flight C S ass Il double insulation Type BF andby CPAP and CPAP with ramp 4 to 20 cm H O 30 cm H O 0 6 cm H O 4 of the measured reading lt 26 dBA 6 48 X 3 30 X 2 02 16 46 cm x 8 38 cm x 5 13 cm 0 oz
21. ecifications 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 v v Power Supply amp Cord HD60 6010 v v USB A to Micro B Cable HD60 6300 v v CPAP Tube Adapter HD60 5020 v v 48 Slim Style CPAP Tube HD60 2010 v v End Cap HD60 501 1 v v Filter HD60 3020 v v Z1 Getting Started Guide HD40 0005 v v User Guide HD40 0007 v v Overnight Battery HD60 7050 v Battery Shuttle HD60 7030 v PowerShell HD60 7020 v PowerShell Getting Started Guide HD40 0012 v Z1 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 health care provider regarding the selection of tubing for your treatment Follow th
22. ing 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 edical Service Center at 1 855 436 8729 1 855 HDMUSA9 before using the Z1 for reatment Do not insert any object into any tubing or opening of your Z1 except as described in his 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 ZT f 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
23. kd rd ga 5 nserting Removing and Replacing the Micro SD Data Card iiiisssissssssssssssssssss 5 WO CIIM ana E E TEE E E A ERE 6 Charging the Battery PowerShell Only oooooooooccccccccccccncccccccrrrn e 6 CANE A A A as EE i E 7 aei R 7 Cleaning PL 7 CPAP Tube Replacement sci o e dl EE RE EUR I US PEE REO DA edu 8 Reminder Alert Air Leak Detection e ese 8 FAUlUGONGILIONS ep rS 9 Troubleshooting eek t ode eR Rr DU E rs ed pem E I Ts S du 9 Technical Specifications acie td teretes e P RUEDA entere a e eau PLE UU DER TN 21 SONVIGING a s oe traci ia bd ida nee Bee losa 22 Limited Warrants ee ee a ERR atus FCR EP DL AUR EAR DAR RE 22 Contacto malo accemiae nar E 22 FAA Compliance ran Eee eh ran Shae ae tts ELE UE CAR dus 23 Product Registration anna ass eh ann eh Bug ATEAN 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 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 breathi
24. king the Z1 Box You will need to perform a few minor setup steps before using your new Z1 The instructions below will guide you through the setup process Some of the steps outlined below may have been performed by your health care provider prior to delivering the Z1 to you If you have any questions or problems as you go through the setup process please call Human Design Medical Customer Service at 1 855 436 8729 1 855 HDMUSAJ for assistance Human Design Medical wants your user experience with the Z1 to be trouble and frustration free 1 Carefully remove the contents of the box 2 Some of the ZT components have their own packaging material Remove this material carefully Avoid using anything sharp when opening the packaging 3 Carefully inspect all contents against the Package Contents list on page 8 to assure all components are present Keep in mind that your health care provider might have completed some of the setup steps prior to delivery so if a component appears to be missing check to see if it has already been connected Also inspect all contents to ensure there is no obvious or visible damage or defects If you have any concerns or questions contact Human Design Medical Customer Service at 1 855 436 8729 1 855 HDMUSA9 or your service or health care provider before use 4 Place all the components in an area where you can easily access the Z1 for set up and programming The contents of the Z1 box includes the f
25. ls 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 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 ZT 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 Sp
26. lter should be changed at intervals specified in this User Guide Accumulation of filtered particles over time can reduce the efficiency and shorten the ife 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 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 Z7 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 lon Battery Careful attention must b
27. ng pattern Leak Compensation the ZT 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 ZT 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 s
28. ollowing Z1 Base Model Power Cord USB Cable Tube Adapter Slim style CPAP tube Z1 CPAP Z1 Unplugged Includes everything that comes with the ZT Base Model plus Battery Shuttle and Overnight Battery PowerShell Assembling and Powering Up Filter and End Cap 1 Remove the Filter from its packaging 2 Insert the Filter into the End Cap aligning the arched side of the Filter with the top ofthe End Cap 3 Ensure the Filter covers all holes in the End Cap so that all air entering the Z7 passes through the Filter and no air bypasses the Filter 4 Press the End Cap onto the Z1 Figure 1 NOTE To remove the End Cap squeeze firmly on the sides of the End Cap and pull it away from the Z1 Tube Adapter CPAP Tube and Mask 1 Connect one end of the CPAP Tube to the round end of the Tube Adapter then insert the other end of the Tube Adapter into the outlet of the Z1 Figure 2 2 Connect the other end of the CPAP Tube to the mask 3 Ensure all connections are tight to avoid air leaks Figure 3 Figure 2 Power Supply AN WARNING The Z1 must only be used with the Human Design Medical Power Supply or the optional Human Design Medical PowerShell with Human Design Medical Battery DO NOT use any other power source with the Z1 CAUTION Make sure the AC power cord IS NOT plugged into an AC power outlet before continuing to the next step 1 Plug th
29. on 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 H5O In the unlikely event of certain fault conditions pressures of up to 30 cm H5O 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 ZT where it can be bumped or where someone is likely to rip over the power cord ake sure your Z1 Power Supply PowerShell and Battery are kept clean dry and free f dust ways make sure the power cord and plugs are in good condition and the quipment is not damaged before use ake 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 fi
30. ower Supply 2 years If product fails to perform in accordance with product specifications Human Design Medical will repair or replace at its option the defective material or part This warranty is only available to the initial purchaser It is not transferable If the product fa Design Medical will repair or replace at its option the ils under conditions of normal use Human defective product or any of its components This limited warranty does not cover a any damage caused as a result of accident improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by Human Design Medical to perform such repairs c any damage or contamination due to cigarette pipe water entering the product Warranty claims on defec cigar or other smoke d damage caused by ive product must be made by the initial purchaser by calling Human Device Medical service support at 1 855 436 8729 THIS WARRANTY REPLACES ALL OTHER EXPRESSED OR IMPLIED WARRANTIES INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITN ESS FOR A PARTICULAR PURPOSE SOME REGIONS OR STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU HUMAN DESIGN MEDICAL SHALL NOT BE RESPONSI CONSEQUENTIAL DAMAGES CLAIMED TO HAVE RES USE OF ANY HUMAN DESIGN MEDICAL PRODUCT S THE EXCLUSION OR LIMITATION OF INCIDENTAL OR ABOVE
31. pecial terms and icons that appear in the text to draw your attention to specific and important information A 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 CPAP System is a single user reusable device that provides continuous positive airway pressure CPAP to support treatment of adults weighing over 66 Ibs 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 Z1 Warnings and Cautions A 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
32. planation Action 21 Flashing Treatment pressure not programmed Discontinue use and contact your health care provider or HDM 22 Flashing Error writing to the installed Micro SD Card Replace defective Micro SD Card If the problem persists contact HDM 27 Flashing Overheating Discontinue use and contact your health care provider or HDM 32 Flashing Over current Discontinue use and contact your health care provider or HDM 33 Flashing Over pressure Discontinue use and contact your health care provider or HDM Human Design Medical Service Center at 1 855 436 8729 1 855 HDMUSAQ Troubleshooting Problem Possible Causes amp Solutions No Display Power is not present Ensure the Power Supply is connected and the power outlet has power Loose connection of the Power Supply at the Z1 or loose connection of the Power Cord at the AC Adapter Check the connections Z1 is not locked into position in the PowerShell Slide the ZT into the PowerShell until it clicks and locks into place Battery is not locked into position in the PowerShell Slide the Battery into the PowerShell until the Battery Shuttle clicks and locks into place Battery is not charged Charge the Battery 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 Treatment Will Not Start Insufficient Air Flow Delivered from Z1 Pressure Rises
33. y Figure 10 CAUTION When using Only Make sure your Battery is fully Ramp Mode has been programmed the ramp start ressing the Start Stop Button and the indicated up to prescribed treatment pressure If the incorrect r health care provider before commencing CPAP he PowerShell Current Treatment charged before commencin using the PowerShell The battery life of a fully charged battery in the PowerShell is typically 8 hours or longer and treatment will terminate when the cha 2 Press the Start Stop Button a second time to stop treatment g CPAP therapy Pressure Start Stop Button rge is expended Figure 10 Programming Ramp Mode Some users find it comforting to acclimate to CPAP therapy each session This can be accomplished by programming the Ramp Mode which allows you to start with a low initial pressure and gradually Ramp Time Ramp increase to the prescribed treatment pressure Bu A D Setting Ramp Time Up Bos Arrow When the ZT is in standby mode press and hold the Button Up Arrow Button for approximately 3 seconds until the 00 MINUTES value flashes While it is flashing repeatedly press either the Up or Down Arrow Buttons to increase or decrease the ramp time in 5 minute increments Figure 11 Set the ramp time to 00 MINUTES to disable the Ramp Mode When the desired ramp time value is reached press and hold the Start Stop Button for approximately 3
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