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Breas Z2 - User Manual

Breas Z2
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Z2
®
CPAP System
CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
User Guide
User Guide
English
Breas Medical, Inc.
N. Billerica, MA 01862
USA
Z2 User Guide v1 10122021
#40-0110 Rev. D

Questions and Answers

Summary

Welcome and Medical Information

Owner;User Responsibility

Defines the user's responsibility for reading the guide and potential consequences of misuse.

Healthcare Provider Responsibility

Outlines the role of the healthcare provider in explaining usage and contraindications.

Replacement Z2 Parts and Supplies

Advises using only genuine parts to avoid damage and warranty voidance.

Terms Used in this User Guide

Explains the meaning of symbols like WARNING, CAUTION, and NOTE.

Indications for Use

Specifies the intended use of the Z2 CPAP System for adults with obstructive sleep apnea.

Contraindications

Lists pre-existing conditions where positive airway pressure therapy may be contraindicated.

Adverse Effects

Lists potential side effects users may experience during CPAP therapy.

Z2 Warnings and Cautions

General Warnings

Covers risks of misuse, oxygen, damage, and mask compatibility.

Electrical and Environmental Hazards

Covers electrocution, cleaning agents, flammable environments, and toxic vapors.

Usage and Storage Precautions

Handling and Cleaning Cautions

Covers tripping hazards, keeping device dry, power cord inspection, and area cleanliness.

Operating Environment and Storage

Covers temperature, humidity, altitude, and avoiding blockages.

Getting to Know Your Z2 CPAP System

Package Contents

Lists all items included in the Z2 CPAP system box.

Z2 CPAP Device Overview

Describes the primary function and features of the Z2 CPAP device.

Power Supply Details

Explains the function and connection of the AC power adapter and cord.

Tube Adapter and CPAP Tube

Describes the purpose and connection of the tube adapter and CPAP tube.

Using Your Z2

LCD Display Overview

Explains the various indicators and information shown on the Z2's LCD screen.

Treatment Pressure and Ramp Mode

Describes pressure display and ramp mode indicators on the LCD.

Battery and AC Power Indicators

Explains icons for battery status and AC power connection.

Z2 Operation Controls

General Status Display and Event Codes

Explains the general status display and event codes shown on the Z2.

Starting and Stopping Treatment

Details how to begin and end therapy sessions using the Start/Stop button.

Auto Stop Feature

Explains the automatic stopping function and how to manage it.

Choosing Z-Breathe Settings

Guides on selecting Z-Breathe levels for comfortable therapy.

Programming Ramp Mode

Setting Ramp Time

Explains how to set the duration for gradual pressure increase.

Setting Ramp Start Pressure

Details how to adjust the initial pressure level for ramp mode.

User Software and Device Care

Breas Medical User Software

Describes the software for data viewing and where to download it.

Inspections

Advises on daily inspection of the device, tube, filter, and mask for wear.

Cleaning Procedures

Provides instructions for daily cleaning of the CPAP tube and Q-lite.

Device Care and Troubleshooting

Filter Replacement

Explains how and when to replace the air filter.

Fault Conditions and Codes

Lists fault codes and recommended actions for troubleshooting.

USB Firmware Upgrade

Guides on where to find firmware upgrades and instructions for the Z2.

Troubleshooting Common Problems

Provides solutions for issues like no display, treatment not starting, or shutoffs.

Guidance and Manufacturers Declaration

Electromagnetic Emissions

Details RF emissions and their classification for the Z2 CPAP System.

Electromagnetic Immunity

Outlines immunity test levels and compliance for the Z2 CPAP System.

RF Communication Separation Distances

Provides recommended separation distances for RF equipment.

Z2 Bluetooth Communication

Discusses wireless quality of service for the Z2 Mobile App.

Technical Specifications

30 W Power Adapter Specs

Lists operating and storage conditions for the power adapter.

Device Specifications

Details operating parameters, dimensions, and weight of the Z2 device.

Performance Specifications

Outlines operating pressure range, accuracy, and sound level.

Bluetooth Specifications

Lists technical details for the Z2's Bluetooth module.

Servicing, Warranty, and Contact

Service Recommendations

Advises on when to get the Z2 system inspected or serviced.

Limited Warranty Details

Lists warranty periods for the Z2 device, PowerShell, battery, and power supply.

Warranty Limitations and Claims

Outlines what the warranty covers, exclusions, and how to make a claim.

Breas Medical Contact Information

Provides company address, phone numbers, and email for support.

FAA Compliance for Aircraft Use

Explains FAA compliance and requirements for using the Z2 on aircraft.

Overview

The Z2 CPAP System, designed, engineered, and assembled in the USA by Breas Medical, is a single-user, reusable device that provides continuous positive airway pressure (CPAP) therapy for adults weighing over 66 lbs (30 kg) with obstructive sleep apnea (OSA). This portable CPAP device is designed with user comfort and convenience in mind, offering several features to enhance the treatment experience.

Function Description:

The Z2 CPAP System delivers continuous positive airway pressure to support the treatment of OSA. It is designed to be used with CPAP masks (or connectors) that have vent holes to allow continuous airflow. When the Z2 is operating, new air flushes exhaled air out through these mask vents. The device's motor and firmware, combined with the Q-lite muffler, work to minimize both dynamic and static noise at the device and within the mask, contributing to a quieter therapy experience. The Z2 automatically adjusts to altitudes up to 8000 ft above sea level and is approved for use on airplanes, adjusting to cabin pressure. The device's firmware and software can be easily updated via a USB cable and a computer, ensuring that users can benefit from the latest improvements.

Usage Features:

The Z2 CPAP System incorporates several features aimed at improving user comfort and ease of use:

  • Z-Breathe® Comfort Feature: This proprietary algorithm is engineered to minimize the impact of pressure spikes and drops that typically occur during exhalation and inhalation on CPAP devices. By keeping the pressure constant, Z-Breathe delivers more comfortable therapy. Users can choose from three levels of Z-Breathe settings (1, 2, or 3) to accommodate individual preferences, with level 1 offering mild pressure swing relief, level 2 being the default for moderate relief, and level 3 providing the most aggressive relief. These settings can be adjusted in standby mode using the Up and Down Arrow Buttons and saved with the Start/Stop Button.
  • Leak Compensation: The Z2 automatically compensates for minor air leakage, helping to ensure that the proper treatment pressure is maintained throughout therapy.
  • Auto Stop Feature: The device is equipped with an Auto Stop Feature that automatically stops treatment when the mask is removed. To restart therapy, the user simply places the mask back on their face and presses the Start/Stop Button. This feature can be disabled if the user prefers to stop the Z2 manually.
  • Ramp Mode: For users who find it comforting to acclimate to CPAP therapy gradually, Ramp Mode allows for a low initial starting pressure that gradually increases to the prescribed treatment pressure over a programmed interval. The ramp time can be set in 5-minute increments using the Up and Down Arrow Buttons, and the ramp start pressure can be adjusted by 0.5 cm H2O increments.
  • LCD Display: The Z2 features an LCD display that shows the current treatment pressure, ramp progress, ramp time remaining, and, if connected, battery status and AC power indication. In standby mode, it alternates between displaying the current date, function mode, Z-Breathe setting, and Auto Stop feature. The display also provides notifications for certain events and "FAULT" codes if operational problems occur.
  • PowerShell (Optional Accessory): The PowerShell houses both the Z2 and a battery, enabling temporary usage of the Z2 without the need for the Power Supply, offering portability for travel or during power outages.
  • Heat Moisture Exchanger (HME): The disposable HME captures moisture from exhaled breath and returns it during inhalation, providing humidification without electricity or complex moving parts. It connects between the CPAP tube and the mask.
  • Q-lite Muffler: This reusable accessory is designed to reduce acoustic noise transmitted through the CPAP tube to the patient mask. It has standard end fittings and can be used with any standard or slim-style CPAP tube.
  • User Data Viewing: Breas Medical provides User Software that can be downloaded to a Windows computer, allowing users to collect and view their therapy data.

Maintenance Features:

Regular care and maintenance are essential for the safe and effective operation of the Z2 CPAP System:

  • Cleaning: The exterior of the Z2 should be cleaned with a soft damp cloth and mild detergent, then wiped clean. The device should never be submerged in water. The CPAP tube should be washed in warm water with mild detergent, rinsed thoroughly, and allowed to dry. The Q-lite muffler should not be washed; it should be examined for cracks or breaks and replaced as necessary.
  • Filter Replacement: The Z2 uses a specially designed filter that should be inspected weekly for holes and blockage by dirt and dust. It should be replaced monthly or more often if necessary. The filter is accessed by removing the End Cap. Only genuine Z2 replacement filters supplied by Breas Medical should be used. The air filter is not washable or reusable.
  • CPAP Tube Replacement: The CPAP tube should be replaced every 90 days or earlier if it becomes discolored, cracked, or damaged.
  • Inspections: Before each use, the Z2, CPAP Tube, filter, and mask should be inspected for signs of wear, damage, or discoloration.
  • Firmware Upgrades: Z2 firmware upgrades and instructions are available on the Breas Medical website, allowing users to keep their device updated.

The Z2 CPAP System is designed to be user-friendly, with clear instructions provided in the User Guide for setup, operation, and maintenance. Users are advised to consult their healthcare provider for any questions or concerns regarding their therapy and device use.

Breas Z2 Specifications

General IconGeneral
Pressure Range4-20 cm H2O
Sound Level26 dBA
TypeCPAP
Dimensions6.48 x 3.30 x 2.02 inches
Power Supply100-240V AC, 50/60Hz
HumidificationOptional
Therapy ModesCPAP
Ramp0-45 min
Operating AltitudeUp to 8, 000 feet

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