Home

U_Z1_HD40-0007-02_005656_EnEu_L-1

1. Programming Treatment Pressure 0 6 cect cece eee e eee n seen eens ena en beseesentenesteeenege 5 Programming Ramp ModE sr brne asrar ie A A 5 Z Breathe Algorithm Selection 00 ccc cence eee araa AAGE EEE ETEO EE EERE SEEN 6 User SORtWARE sae sie iet ere bag Sauda eves Me epee ag pa en eae ey ation Helep eee menequs aan 7 Charging the Battery PowerShell Only nn nn nn nn nn nnnnnznnnnnna 7 CANE eroe Koro aiaia aa ARRE EENE S Midas EEEE EE EE RE awe age Mee EE S 8 ASPECUON S araar par a Epin a a A head A ETE A ES AE EEA E EE E OA 8 Cleaning 5 esecaecdudtras de woede AA AAN A AE A ELE AEAT 8 CPAP Tube Replacement ivec es asiec dade aka ers E rata E ERENT ab ba a 9 Reminder Alert Air Leak Detection 0 00 00 nn nar n kr nn EEEE EEEIEE 9 Fat CONAIBONS A ri a i a A E A e s i 20 MMOUBIESMOOIAG nessau wnedaen a eadau tices seals aaden dada TERENE AEA 20 Technical SHSCIMCATIONS raiar nana are EAN EEEE EASA E EEI EARE 21 SEVICIMO gcse idi ata a ip AE Ra rd N i a L a a 22 iPM tea Wara mi ssa ke ib ale Salad cide aatieme eee E E E J dias ade AEO 22 Replacement Z1 Parts and Supplies 00 ccc nenenennenzznnnnnnnnanaezkzanenzzznnznna 23 Contact I MONMAON anh ssa A aerator age ati ek 8 a E REED 23 Z1 Z Breathe and PowerShell are trademarks of Human Design Medical LLC US Patent Pending Copyright 2014 Breas Medical AB All rights reserved Doc HD40 0007 02 En Eu L 1 Welcome to Your Z1 CPAP System Than
2. 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 Breas Medical recommends that customers check with their airline Breas Medical AB Foretagsv gen 1 SE 435 33 M lnlycke SWEDEN Phone 46 31 86 88 00 BREAS Mail completed form to Breas Medical AB F retagsvagen 1 SE 435 33 M lnlycke SWEDEN Register your new device Registering your device allows us to provide better customer service Please register as soon as possible About you NAME First Last EMAIL ADDRESS MAILING ADDRESS Street or PO Box City Zip PHONE NUMBER About the device WHAT DEVICE DID YOU PURCHASE WHERE DID YOU PURCHASE THE DEVICE PURCHASE DATE YY MM DD 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 11042013
3. to disable the Ramp Mode When the desired Ramp Time value is reached press and hold the Start Stop Button for approximately 3 seconds to save your Ramp Time setting this setting will be saved even when the Z1 is not powered The Z1 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 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 HO 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 Doc HD40 0007 02 En Eu L 1 Z Breathe Algorithm Selection Your Z7 unit adjusts its airflow automatically on a breath by b a more comfortable normal breathing pattern You can choo Algorithm settings reath basis so that you can maintain se from the following two Z Breathe CPAP 1 Setting enables the Z Breathe Algorithm at a gentle response rate which adjusts the airflow gradually during the inhalati
4. 15 The LCD screen should be checked for any FAULT messages and A fault condition is indicated when the word FAULT is displayed Figure 15 accompanied by a two digit flashing number in place of the pressure reading The table below provides a listing of fault codes and recommended actions to be taken by the user Fault Code Explanation Action 21 Flashing Treatment pressure not programmed Discontinue use and contact your health care provider or Breas 27 Flashing Overheating Discontinue use and contact your health care provider or Breas 32 Flashing Over current Discontinue use and contact your health care provider or Breas 33 Flashing Over pressure Discontinue use and contact your health care provider or Breas 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 Z1 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 c
5. 7 02 En Eu L 1 Programming Treatment Pressure When the Z1 is in standby mode press and hold the Start Stop Button for 3 seconds until the pressure value flashes While it is flashing repeatedly press either the Up or Down Arrow Buttons to increase or decrease the pressure Figure 11 When you have reached the prescribed pressure press and hold the Treatment Pressure Down Start Stop Button for approximately 3 seconds to r ci Arrow save the treatment pressure setting this setting will Butta Button be saved even when the Z1 is not powered The Z1 will return to standby mode To return to standby mode without saving the new setting press and Figure 11 release the Start Stop Button momentarily instead of holding it down Start Stop Button Programming Ramp Mode Some users find it comforting to acclimate to CPAP therapy each session This can be accomplished by Ramp Tinje programming the Ramp Mode which allows you to start with a low initial pressure and gradually Ramp increase to the prescribed treatment pressure Pressure Setting Ramp Time U ff Eo When the Z1 is in standby mode press and hold the Button 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 Figure 12 Buttons to increase or decrease the Ramp Time in 5 minute increments Figure 12 Set the Ramp Time to 00 MINUTES
6. Contents TOENE e a e en ad 1 Welcome to Your Z1 CPAP Svstem Lsoe sess nneenanzennannnzkennnknnznnzzzznekzzznrnznzznnna ni 2 Owner User Responsibilitvi ssib area esi bo bg bid d io Ba 2 Replacement Z1 Parts and Supplies sse eeesensennnnzesnnnzzantrzzontzzzonzzznntzzani 2 Terms Used in this User Guide 22s ss enenennnnnna rna nenenna nn rna in riesta naras 2 M dicalllhformmatiO ireren desea rae n Ea EE E be E E EEE E igwaatiadeaan as 3 Z1 Warnings and Cautions siz nabs mi isurian nerit pepe i ELEKE EEE OESE RTS 4 Battery Warnings and GaUtONS ess ciresarii onenei e A EREE EEEE FIERES biza 7 Getting to Know Your Z1 CPAP SYSteMi 2 cnccusnamentiy mare aAa EE RERNE piu EAER S 8 Package Comte nts nieren oe eitea A EA EEE EEEO EEEE EE E cadmas 8 Z WOPAPIDEV C Ennni e al aea a OEE E e 9 TUBE Adaptet reesen arerin bie pe EETA EEEIEE EEE E EANA 9 CPAP TUDES isa EA T E EEEE E 9 ENKE o EE A reed aiding s EEE E EE 9 FIG esre n eaa eae E E N O E ETENE 9 YSB MICO CablE rosserae B i a E ENEAS 9 PowerShell Optional Accessorv L 22 cece cece E eE AAEE EEEE EERE RARES 9 IMitialSOtUPssceccs doaenarakehonied MaGadeadaandsed E teds ANTERE CENENE beaded 0 Unpacking the Z1 BOG si a pene a ar alik B paris A wes A a i e A 0 Assembling and Powering Up issibni irkant be a ER aoa b EER EE EN A 1 USIRG OLF ZI isa e 3 KABIBE S ENEE e a E E 3 Starting and Stopping Treatment 0 cece rana eE E SETER ERE EEEN ES EEEIEE 4
7. O Current Date The current date is displayed automatically on the Z1 It is pre programmed at the factory FAULT FAULT is displayed if one of several conditions has occurred that require your attention See Fault Conditions page 19 for explanations of the FAULT codes REMINDER REMINDER is displayed if there is excessive air leakage See Reminder Alert Air Leak Detection page 18 for an explanations of REMINDER conditions Starting and Stopping Treatment 1 Press the Start Stop Button on the Z7 to initiate treatment using the programmed treatment setting The Treatment Pressure Display will show the actual pressure being delivered at all times If the Ramp Mode has been programmed the Ramp start pressure will be displayed upon pressing the Start Stop Button and the indicated pressure will rise as the Z7 Ramps up to prescribed treatment pressure If the incorrect pressure is displayed contact your health care provider before commencing CPAP therapy Figure 10 Current Treatment Pressure CAUTION When using the PowerShell Only Make sure your Battery is fully charged before commencing CPAP therapy 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 charge is expended Start Stop Button 2 Press the Start Stop Button a second time to stop treatment Figure 10 Doc HD40 000
8. P 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 Z7 Replacement filters are available at www breas 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 Z7 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 32 C 90 F Only operate the Z1 and accessories within the operating temperature humidity and altitude conditions specified in the Technical Specifications section of this User Guide Doc HD40 0007 02 En Eu L 1 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 atten
9. 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 Breas To purchase replacement filters visit www breas com A WARNING Do not attempt to use any air filter which is not supplied by Breas for the Z1 The Z1 is designed to only work with approved materials A filter which is not approved may cause damage to the Z7 from overheating B CAUTION Do not operate the Z7 without the Filter The Z7 must operate with a filter installed failure to do so may damage the Z7 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 Doc HD40 0007 02 En Eu L 1 Fault Conditions visible damage daily The Z1 has the ability to detect operational problems and will display the word FAULT on the LCD screen Figure
10. and supplies visit www breas 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 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 Doc HD40 0007 02 En Eu L 1 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 30 kg 66 Ibs 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 Pathologicallv 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 Bloa
11. arran tacting Breas HER EXPRESSED OR IMPLIED WARRA TY OR FITNESS FOR A PARTICU SON HOW LONG AN AY NOT APPLY TO YOU R ANY INCIDENTAL OR CONSEQUENTIAL LTED FROM THE SALE INSTALLATION OR USE OF ANY TIES INCLUDING LAR PURPOSE SO PLIED WARRANTV ANY E CT SOME REGIONS STATES OR COUNTRIES DO NOT ALLOW THE DENTAL OR CONSEQUENTIAL DAMAGES SO THE ABOVE U rights and you may also have other rights which vary from For further informa ion on your warranty rights contact Breas or your health care Doc HD40 0007 02 En Eu L 1 Replacement Z1 Parts and Supplies Use only genuine Z1 replacement filters parts and supplies Replacement filters parts and supplies can be purchased by visiting www breas com Product Description Z1 Base CPAP System Z1 Base System includes Z1 Device Tube Adapter Slim Style Tube Power Supply Custom USB Cable User Manual and Getting Started Guide Z1 Unplugged CPAP System Z1 Unplugged System includes Z1 Base System and PowerShell Module Z1 PowerShell Module Z1 PowerShell includes PowerShell Battery Cradle eoprene Cover amp Lanyard Overnight Battery and Battery Shuttle Z1 Overnight Battery 14 AV rechargeable lithium ion battery pack or the Z1 PowerShell Z1 Custom USB Cable USB to micro USB cable with custom tip for software downloads and data extraction Slim Style Tube Special li
12. ce 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 power outlet Figure 13 CAUTION Make sure your Battery is fully charged before commencing CPAP therapy using the PowerShell The battery life of a fully charged battery in the PowerShell is typically 8 hours or longer after which treatment will terminate To recharge the Battery see Charging the Battery Z7 A Figure 13 a Figure 14 Ensure the Z1 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 Z7 will flash when the Battery is charging The number of solid bars indicates the current level of charge Figure 14 Doc HD40 0007 02 En Eu L 1 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 For replacement parts visit www breas com Cleaning Regular cleaning should be performed in accordance with the instructions below A WARNING This device can expose you to electrocution Do not immerse the Z1 Power Adapter Power Cord or Batte
13. e 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 Z1 Description Z1 Base Model Unplugged Z1 CPAP Device A A Power Supplv Y A Power Cord EU w w Power Cord UK USB A to Micro B Cable CPAP Tube Adapter CPAP Tube End Cap Filter Heat Moisture Exchange Unit HME Z1 Getting Started Guide User Guide Overnight Battery S S MA S DDAA Batterv Shuttle PowerShell PowerShell Getting Started Guide MA ES S Be S Be DAS 1 Only one power cord is in the package Doc HD40 0007 02 En Eu L 1 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 Z7 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 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 the instructions provided with the tubing To purchase replac
14. ea 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 Breas service agent Only power the Z1 with the Z1 Power Supply AC to DC power adapter or the optional Z1 PowerShell with Breas Medical Battery Do not use any other AC adapters batteries or other power sources to power the Z1 Do not use the Z1 Power Supply PowerShell or Battery to power any device other than the Z1 Your Z1 should only be used with standard 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 Doc HD40 0007 02 En Eu L 1 Do not connect or insert any device cable or articles into the Micro USB or Micro SD ports of your Z7 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 sho
15. ement tubing visit www breas com End Cap The End Cap attaches to the air intake end of the Z7 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 To purchase replacement Filters visit www breas 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 Z7 and the Battery which allows temporary usage of the Z1 without the Power Supply To purchase the PowerShell visit www breas com Doc HD40 0007 02 En Eu L 1 Initial Set Up Unpacking the Z1 Box You will need to perform a few minor setup steps before using your new Z7 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 Z7 to you If you have any questions or problems as you go through the setup process please contact Breas or your health care provider for assistance Breas wants your user experience with the Z7 to be trouble and frustration free 1 Carefully remove
16. ess 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 Doc HD40 0007 02 En Eu L 1 Power Supply A WARNING The Z1 must only be used with the Z1 Power Supply or the optional Z1 PowerShell with Breas 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 the 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 Z7 will enter standby mode The display will read 0 0 Figure 5 NOTE The Z7 display will be active whenever the device is receiving power PowerShell and Battery Available Separately or as Part of Z1 Unplugged WARNING The Z1 must only be used with the optional Z1 PowerShell with Breas Battery or the Z7 Power Supply DO NOT use any other power source with the Z1 1 Slide the Batter
17. ghtweight thin pressure delivery ube for use with the Z1 Device Z1 Polyester Filter 2 pack 2 each Z1 Polyester Air Filters Z1 Polyester Filter 6 pack 6 each Z1 Polyester Air Filters Z1 Custom Tube Adapter Z1 custom outlet Tube Adapter required for Z1 operation Heat Moisture Exchange Unit HME In line humidification for the Z1 Device Z1 Power Supply AC Adapter 100 240V Z1 Power Cord EU AC Power Cord with EU Plug Z1 Power Cord UK AC Power Cord with British Plug Z1 Plastic Filter End Cap Z1 Filter Housing and Cover Z1 DC Mobile Adapter Enables the Z1 to be powered by plugging into a 12 volt vehicle outlet Contact Information BREAS Breas Medical AB FOretagsvagen 1 SE 435 33 M lnlycke SWEDEN www breas com Phone 6 31 86 88 00 Order 6 31 86 88 20 Technical Support 6 31 86 88 60 Email breas breas com 23 Doc HD40 0007 02 En Eu L 1 24 Doc HD40 0007 02 En Eu L 1 If you are planning on using your Z1 on an airplane please detach this letter and carry it with you BREAS 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 req
18. k you for choosing the Z7 CPAP System from Breas 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 Z7 automatically compensates for minor air leakage helping ensure the proper treatment pressure is maintained Auto Altitude Adjustment the Z1 adjusts to altitudes up to 2400 meters 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 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 To purchase replacement filters parts
19. lass II 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 16 46 cm x 8 38 cm x 5 13 cm 6 48 x 3 30 x 2 02 238 g 10 oz Flame retardant engineered thermoplastic Q ot 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 225 g 8 oz The following symbols may appear on your device power supply unit or packaging A Caution type BF equipment m Class Il equipment Start stop gal Manufacturer Batch code LREF catalog number SN serial number esi Direct current Not for use on more than one patient g Product disposal warning to EN50419 C 0123 CE marking applies in accordance with the directive MDD 93 42 EEC Doc HD40 0007 02 En Eu L 1 21 Servicing The Z1 System is intended to provide safe and reliable operation when operated in accordance with the instructions provided by Breas Breas recommends that the Z7 System be inspected and serviced by an authorized Breas 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 period see Limited Warranty for details of the device Limited Warranty Breas warrants that your Breas product shall be free from defects in material and workmanship from the date of
20. mell feels hot changes color changes shape or appears abnormal in any other way Contact Breas or your health care provider if any of these problems are observed Do not place the Battery in microwave ovens high pressure containers or on induction cookware n 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 Z1 PowerShell and the supplied Z1 Power Supply Do not use any other removeable battery charger AC adapter or other device to charge the Battery Doc HD40 0007 02 En Eu L 1 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 Z7 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 Guid
21. nd 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 Z7 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 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 Doc HD40 0007 02 En Eu L 1 Before use make sure the power cord and plug are in go
22. od 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 Z7 be dropped and fail to operate properly contact Breas or your health care provider before using the Z7 for treatment 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 Z1 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 ar
23. on nected to the Z7 Remove the power supply unit and replace with a Breas approved unit Doc HD40 0007 02 En Eu L 1 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 Check the display for a fault condition Refer to the Fault Codes table in Fault Conditions Contact Breas or your health care provider 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 imme diately Mask and or headgear are not positioned correct ly 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 ca
24. on exhala the algorithm will initially adjust rapidly to breathing but ion cycle In this setting he adjustments will become gentle and gradual after a few inhalation exhalation cycles CPAP 2 Setting enables the Z Breathe Algorithm at an aggressive response rate which adjusts the airflow rapidly during the inhalation ex You can change the setting of the Z Breathe Algorithm when halation cycle your Z1 unit is in Standby Mode pressure of 0 0 indicated on the display To change the setting hold down both the up and down arrow buttons at the same time until you see CPAP 1 or CPAP 2 flashing on the display Press the up or down arrow buttons until you observe your desired setting on the display To lock in the setting hold down the Start Stop button until the CPAP X indicator no longer flashes on the display Your selected setting for the Z Breathe Algorithm will be retained in the memory of your Z7 unit after it is turned off The currently selected Z Breathe Algorithm setting will be displayed when the Z1 is delivering treatment pressure 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 Z1 PowerShell and the supplied Z1 Power Supply Do not use any other battery charger AC adapter or other devi
25. purchase for the period specified below Componen ZI device PowerShell Overnight Batterv Power Supplv t Warrantv Period 3 years 2 years 9mo nths 2 years If product fails to perform in accordance with product specifications Breas will repair or replace at its option the defective material or part This warranty is only available to not transferable If the product fails under its option the defective product or any of any damage caused as a result of acciden product b repairs carried out by any servi by Breas to perform such repairs c any damage or contamination due to damage caused by wa oduct must be made by the initial purchaser by con or other smoke d p THIS WARRANTY M RE A REAS MEDICAL AMAGES CLAI REAS MEDICAL B D B MITATION MAY Thi region to region provider 22 PLIED WARRANTY OF GIONS OR STAT STS SO THE ABOVE LI XCLUSION OR L s warranty gives you s REPLACES ALL OT ITATION SHALL ED TO HAVE RESU PRODU MITATION OF INC NOT APPLY TO YO pecific lega ERCHANTABIL TES DO NOT ALLOW LIMITATIO OT BE RESPONSIBLE FO he initial purchaser It is will repair or replace at rranty does not cover a ion or alteration of the ion that has not been expressly authorized cigarette pipe cigar ty claims on defective conditions of normal use Breas its components This limited wa t improper use abuse modifica ce organiza er entering the product W
26. ry 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 6 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 Adapter 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 Z1 and mask Doc HD40 0007 02 En Eu L 1 As Needed 1 Clean the exterior of the Z7 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
27. setting of 10 0 cm H O is displayed in Figure 9 Ramp Progress 8 B 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 4 Batterv Status Displav PowerShell Onlv Ramp Progress o O AC Power Indicator O Ramp Time Remaining Fault oQ Treatment Pressure Display Reminder O Figure 9 Doc HD40 0007 02 En Eu L 1 O 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 For example the icon shown in Figure 9 indicates that the Battery has between 25 50 of charge remaining Make sure the Battery is fully charged before each use Number of Solid Bars Charge Remaining 1 10 25 2 25 50 3 50 75 4 75 100 AC Power Indicator This icon is displayed when the Z1 is connected to an AC power outlet via the Power Supply
28. the contents of the box 2 Some of the Z1 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 Breas or your health care provider before use A 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 following Z1 Base Model Power Cord USB Cable AC DC Adapter Mas Tube Adapter Z1 CPAP Doc HD40 0007 02 En Eu L 1 Z1 Unplugged Includes everything that comes with the Z7 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 of the 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 A Pr
29. ting Skin rashes Ear or sinus discomfort Doc HD40 0007 02 En Eu L 1 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 understand 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 Z7 Do not connect supplementary oxygen or other gas to any accessory or patient interface which is connected to your Z1 Ifyou notice any unexplained changes in the performance of your Z1 or your Z1 is making unusual or harsh sounds or if the Z7 or Power Supply are dropped or mishandled discontinue use and contact Breas or your health care provider lf 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 Breas or your health care provider 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 Z7 is turned on a
30. tion 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 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 mmediatelv discontinue use of the Battery if while using charging or storing the Battery the Battery emits an unusual s
31. uirements respiratory assistive devices may be used onboard an 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 Breas 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 Breas Medical recommends that customers check with their airline Breas Medical AB F retagsvagen 1 SE 435 33 M lnlycke SWEDEN Phone 46 31 86 88 00 BREAS 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 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 Breas Medical has successfully completed testing for the Z1 CPAP System The
32. uld 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 H O In the unlikely event of certain fault conditions pressures of up to 30 cm H O are possible Blocking the CPAP Tube while in operation could lead to overheating of the Z1 Inthe clinical environment any personal computer that is used with your CPAP system must be at least 1 5 meters 5 ft away from or at least 2 5 meters 8 ft 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 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 Z7 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 Z7 will enter standby mode and all prior settings will be retained in memory Follow the storage and cleaning instructions provided with your CPA
33. used 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 pow er cord and then reconnect it to restart the Z7 20 Doc HD40 0007 02 En Eu L 1 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 IEC 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 Unit Input range 100 240V 50 60Hz Typical power consumption 20W 30VA Maximum power consumption 35W 70VA 5 C to 35 C 41 F to 95 F 10 80 Relative Humidity Non Condensing Sea level to 2400 m 8000 ft 101 to 75 3 kPA 20 C to 60 C 4 F to 140 F 10 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
34. y 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 Z7 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 Figure 4 Figure 5 Figure 7 Doc HD40 0007 02 En Eu L 1 3 The Z7 will power up and cycle through a series of startup displays A After about 10 seconds the Z1 will enter standby mode The display will read 0 0 Figure 8 Figure 8 NOTE Remove the Battery from the PowerShell when the Z1 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

U_Z1_HD40-0007-02_005656_EnEu_L-1

Contents

Download Pdf Manuals

Related Search

Related Contents