Breas Z1 User Manual
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Breas Z1 User Manual

Cpap system
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Contents
Welcome to Your Z1 CPAP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Owner/User Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Physician Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Replacement Z1 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 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Z1CPAP Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Tube Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
CPAP Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
End Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
USB Micro Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
PowerShell (Optional Accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Initial Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Unpacking the Z1 Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Assembling and Powering Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Using Your Z1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Starting and Stopping Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Programming Treatment Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Programming Ramp Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
User Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
USB Firmware Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Charging the Battery (PowerShell Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
CPAP Tube Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Reminder Alert (Air Leak Detection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
PowerShell Battery Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Symbol Explanation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Replacement Z1 Parts and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
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-4
1

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Summary of Contents for Breas Z1

  • Page 1: Table Of Contents

    Replacement Z1 Parts and Supplies ........

  • Page 2: Welcome To Your Z1 Cpap System

    • 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.

  • Page 3: Terms Used In This User Guide

    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 30 kg (66 lbs) with obstructive sleep apnea (OSA).

  • Page 4: Z1 Warnings And Cautions

    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.
  • Page 5 CPAP Tube and/or air inlet of your Z1 while in operation could lead to overheating of the Z1. • If you put the Z1 on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air inlet or cover the Power Supply unit.
  • Page 6 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.

  • Page 7: Battery Warnings And Cautions

    • 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 Breas or your health care provider if any of these problems are observed.
  • Page 8 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.

  • Page 9: Getting To Know Your Z1 System

    Getting to Know Your Z1 System Package Contents Description Z1 Base Model Unplugged Z1 CPAP Device ✔ ✔ Power Supply with Power Cord ✔ ✔ USB A to Micro B Cable ✔ ✔ CPAP Tube Adapter ✔ ✔ CPAP Tube ✔...

  • Page 10: Z1Cpap Device

    Follow the instructions provided with the tubing. To purchase replacement tubing visit www.breas.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.

  • Page 11: Initial Set Up

    If you have any concerns or questions, contact Breas or your 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.

  • Page 12: Assembling And Powering Up

    Z1 Unplugged Includes everything that comes with the Z1 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.
  • Page 13 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)

  • Page 14: Using Your Z1

    Treatment Pressure Display The current treatment pressure is shown on the LCD display. Once set, the prescribed treatment pressure will be retained in the Z1’s memory even during loss of power. For example, a treatment pressure setting of 10.0 cmH O is displayed in Figure 9.
  • Page 15 75-100% AC Power Indicator This icon is displayed when the Z1 is connected to an AC power outlet via the Power Supply. General Status Display In standby mode, this display field shows the current date. During treatment it shows the currently selected Z-Breathe setting (1, 2 or 3).

  • Page 16: Starting And Stopping Treatment

    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 Z1 Ramps up to prescribed treatment pressure. If the incorrect pressure is displayed, contact your health care provider before commencing CPAP therapy.

  • Page 17: Programming Ramp Mode

    A Z1 firmware upgrade can be downloaded via the Patient Software. To upgrade the firmware on your Z1 connect the Z1 to your PC with a USB cable. The USB firmware upgrade can also be used to set the date and time on the Z1.
  • Page 18 — CPAP 3 is the most aggressive setting for pressure swing relief You can change the setting of the Z-Breathe Algorithm when 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 –...

  • Page 19: Charging The Battery (Powershell Only)

    NOTE: The battery will not charge if you are using the device at the same time. Care The Z1 System needs periodic care. It is the user’s responsibility to be aware of the following items for care: • Inspections • Cleaning •...

  • Page 20: Cpap Tube Replacement

    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. As Needed 1. Clean the exterior of the Z1 with a soft damp cloth and mild detergent and wipe clean.

  • Page 21: Reminder Alert (Air Leak Detection)

    • Mask to face (adjust position of mask and headgear to eliminate the air leak) Fault Conditions The Z1 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.

  • Page 22: Troubleshooting

    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.
  • Page 23 Try a standard bore (22mm) CPAP Tube. Often these larger bore tubes come with your home device and they are approved to use with your Z1. Use a stand alone Heated Humidifier with your Z1 while at home. The volume in the water chamber will greatly reduce any mask noise.

  • Page 24: Guidance And Manufacturer's Declaration Electromagnetic Emissions & Immunity

    Guidance and manufacturer’s declaration - electromagnetic emissions The Z1 CPAP System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z1 CPAP System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment —...
  • Page 25 Guidance and manufacturer’s declaration — electromagnetic immunity The Z1 CPAP System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z1 CPAP System should assure that it is used in such an environment. Immunity test...
  • Page 26 Guidance and manufacturer’s declaration — electromagnetic immunity The Z1 CPAP System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z1 CPAP System should assure that it is used in such an environment. Immunity test IEC 60601 test...
  • Page 27 The Z1 and Mobile App utilize only a very small fraction of the available bandwidth and through- put. Based on this, the Z1 and Mobile App are highly tolerant of reductions in wireless quality of service and performance will not be affected until service is essentially lost; Wireless connectivity is not part of the essential performance of the Z1 performance.

  • Page 28: Technical Specifications

    Lithium Ion Battery Pack 4S1P Weight approx. 225 g (8 oz.) Expected Service Life Z1, PowerShell and Power Supply: 5 years Tube Adapter, USB Cable and End Cap: 2 years Filter: See Care Instructions CPAP Tube: See CPAP Tube Instructions Performance Specifications...

  • Page 29: Powershell Battery Specifications

    -20 º C to +60 º C (-4 º F to +140 º F) Storage and transport temperature Storage and transport humidity ≤ 80% Relative Humidity, Non-Condensing Battery Technology Lithium Ion Battery Pack, 4S1P Weight Approx. 227 g (8 oz.). Charging Battery charges when Z1 not in use Doc. HD40-0007-02 En-Eu L-4...

  • Page 30: Symbol Explanation

    Symbol Explanation The following symbols may appear on your device, power supply unit, or packaging. Start/Stop Serial number Catalog number Batch code Caution Class II equipment Type BF equipment Product disposal warning according to EN50419 Manufacturer Date of Manufacture: YYYY-MM Read user instructions Degree of protection provided by enclosure.

  • Page 31: Servicing

    Breas. Breas recommends that the Z1 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’...

  • Page 32: Replacement Z1 Parts And Supplies

    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.
  • Page 33 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 • Företagsvägen 1 • SE 435 33 Mölnlycke • SWEDEN Phone: +46 31 86 88 00...
  • Page 35 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 11042013...

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