Z2® Auto System

CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

User Guide

User Guide
English

Q-lite™ is a trademark of Breas Medical, Inc. Z2®, PowerShell®, NiteLog® and Z-Breathe® are registered trademarks of Breas Medical, Inc. Breas and the Breas logo are trademarks of Breas, AB. All other trademarks are the property of their respective owners.
US Patent Pending. © Copyright 2014-2021, Breas Medical, Inc. All rights reserved.

Welcome to Your Z2 Auto System

Thank you for choosing the Z2 Auto System from Breas Medical -­ designed, engineered, and assembled in the USA with you in mind.

The Z2 is specially designed with these features:

• The Z2 motor and firmware combination along with the Q-lite are designed to minimize both dynamic and static noise at the device and within the mask.
• Z-Breathe® Comfort Feature – Z-Breathe is designed to minimize the impact of spikes and drops while keeping the pressure constant, thereby delivering more comfortable therapy.
• Leak Compensation – the Z2 automatically compensates for minor air leakage helping ensure the proper treatment pressure is maintained.
• Auto Altitude Adjustment – the Z2 adjusts to altitudes up to 8000 ft above sea level.
• Air Travel – The Z2 adjusts to an airplane’s cabin pressure and is approved for use on airplanes.
• Upgradable Operating System-­ the Z2 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 portable CPAP device. Please read this User Guide carefully before using your Z2.

Owner/User Responsibility

The owner/user of the Z2 Auto System is responsible for reading and understanding this User Guide. The user is responsible for any injury or damage that results from:

• Operation of the Z2 other than in accordance with the operating instructions contained in the User Guide supplied.
• Unauthorized maintenance or modifications to the device or attached accessories.

Healthcare Provider Responsibility

Your healthcare provider is responsible for explaining contraindications and instructions for use to the patients/users.

Replacement Z2 Parts and Supplies

Use only genuine Z2 replacement filters, parts and supplies. Replacement filters, parts and supplies can be purchased from a retail medical supplier or at www.smallcpap.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.

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 Z2 Auto System is a single user, reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea (OSA).

Contraindications

Positive airway pressure therapy may be contraindicated in some individuals with the following pre-existing conditions:

• Severe bullous lung disease
• Pneumothorax
• Pathologically low blood pressure
• Dehydration
• Cerebrospinal 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.

Z2 Warnings and Cautions

WARNINGS:

• Read the entire User Guide before using your Z2. Consult your health care provider if there is any part of this User Guide you do not understand.
• US Federal law restricts this device to sale by or on the order of a physician.
• Use your Z2 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 Z2 is not approved for use with oxygen. Do not use supplemental oxygen or any other type of supplementary gas with your Z2. Do not connect supplementary oxygen or other gas to any accessory or patient interface which is connected to your Z2.
• If you notice any unexplained changes in the performance of your Z2 or your Z2 is making unusual or harsh sounds, or if the Z2 or Power Supply are dropped or mishandled, discontinue use and contact the Breas Medical Service Center at 1-855436-8724.
• If your Z2 , 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 Breas Medical Service Center at 1-855-436-8724.
• A mask is not provided. Your Z2 should only be used with masks and connectors recommended by your physician, clinician, respiratory therapist or health care provider.
• Your Z2 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 Z2 is turned on and functioning properly, new air from the Z2 flushes the exhaled air out through the mask vent holes. However, when the Z2 is not operating properly (e.g., at low pressure) or the Z2 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 Z2 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 Z2 with a mask unless the Z2 is turned on. Once the mask is fitted, confirm that air is flowing from your Z2.
• Do not block the vent hole or holes in the mask. Follow the mask manufacturer’s instructions for proper use of the mask.
• In the event of a power failure or machine malfunction, remove the mask immediately.
• At low pressures some exhaled gases may remain in the mask.
• Electrocution Hazard – Your Z2 is an electrical device, and as such, you should not immerse your  Z2 , Power Supply , PowerShell or Battery in water. Always unplug your Z2 and its accessories before cleaning (and clean only as instructed in this User Guide) and make sure your Z2 and its accessories are dry before plugging back in.
• Before use, make sure the power cord and plug are in good condition and that the cord is not damaged.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean your Z2 , 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 Z2 , Power Supply , PowerShell or Battery in the vicinity of flammable anesthetics or oxygen.
• Do not use your Z2 near toxic or harmful vapors.
• Do not drop your Z2 or any of its accessories or expose it to any crushing forces. Should your Z2 be dropped and fail to operate properly, contact the Breas Medical Service Center at 1-855-436-8724 before using the Z2 for treatment.
• Do not insert any object into any tubing or opening of your Z2 except as described in this User Guide.
• Do not operate your Z2 in any area which may block its air intake. Blocking the CPAP Tube and/or air inlet of your Z2 while in operation could lead to overheating of the Z2.
• If you put the Z2 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 Z2 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  Z2 , Power Supply , PowerShell or Battery in an area which may cause overheating.
• Do not cover the Power Supply , PowerShell or Battery with any object or material which would cause them to overheat.
• Keep the power cord, Power Supply , Battery and Z2 away from hot or flammable surfaces, gases or materials.
• Do not open your Z2 or tamper with its accessories. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorized Breas Medical service agent.
• Only power the Z2 with the Breas Medical Power Supply (AC-to-DC power adapter) or the optional Breas Medical PowerShell with Breas Medical Battery. Do not use any other AC adapters, batteries, or other power sources to power the Z2. Do not use the Breas Medical Power Supply , PowerShell or Battery to power any device other than the Z2.
• Your Z2 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 Z2 except as described in this User Guide. Connecting other devices could result in injury to you or damage to the Z2 and void the warranty.
• Do not locate your Z2 in an unapproved place or where the air intake can be blocked during treatment. This will lead to overheating of the Z2. If a blocked intake should occur during operation, the unit may stop supplying pressurized air and cause a fault condition. Refer to “Troubleshooting” in this User Guide to interpret this fault and instructions for corrective action.
• The Z2 is designed to deliver pressures from 4 to 20 cm H2O. In the unlikely event of certain fault conditions, pressures of up to 30 cm H2O are possible.
• Blocking the CPAP Tube while in operation could lead to overheating of the Z2.
• 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 Z2 where it can be bumped or where someone is likely to trip over the power cord.
• Make sure your Z2 , Power Supply , PowerShell and Battery are kept clean, dry, and free of dust.
• Always make sure the power cord and plugs are in good condition and the equipment is not damaged before use.
• Make sure the area around your Z2 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 Z2 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 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 Z2. Replacement filters are available at your retail medical supplier or at www.smallcpap.com.
• Do not wash the air filter. The air filter is not washable or reusable.
• The End Cap protects the Z2 in the event of a minor collision. Always ensure that the End Cap is securely fitted in accordance with instructions at all times. The Z2 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 Z2 at room temperatures warmer than 90°F (32°C).
• Only operate the Z2 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 Z2 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.

Getting to Know Your Z2 Auto System

Package Contents

Z2 Auto Device
Power Supply (AC Adapter and Power Cord)
Custom USB A to Micro B Cable
Custom CPAP Tube Adapter
4 ft. Slim Style CPAP Tube
Filter (2- 1 installed in Z2, 1 in box)
Heat / Moisture Exchanger (HME)
Q-lite Muffler
8 in. Slim Style CPAP Tube
Z2 Auto Quick Start Guide
Z2 Auto User Guide

Z2 Auto Device

The Z2 supplies continuous positive airway pressure and can be programmed to fit the patient’s prescriptive needs.

Power Supply (AC Adapter and Power Cord)

The Power Supply provides power to the Z2. It takes AC power (voltage ranging from 100-240 volts) from a wall outlet and converts it to DC voltage to power the Z2. 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 Z2.

CPAP Tube

The Z2 System is provided with a 4 ft slim style CPAP Tube. The CPAP Tube connects the Z2 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.

1. 8″ CPAP tube
2. Q-lite
3. Power Cord
4. HME
5. AC Adapter
6. USB Cable
7. Filter
8. Z2 Auto
9. Tube Adapter
10. 4′ Slim-style CPAP tube

Filter

The Z2 uses a specially designed filter. The material has been specifically chosen for the Z2 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 Z2 , which was designed to allow for more effective filter surface area.

For proper operation of the Z2 , the Filter should be replaced monthly or more often if necessary.

USB A to Micro B Cable

The USB Cable allows the Z2 to communicate with a computer to collect and view user data. It also can be used to install new firmware when it becomes available.

Heat Moisture Exchanger (HME)

The disposable HME works by capturing moisture as you exhale and provides it back to you as you breathe. The HME does not use any electricity or complex moving parts and avoids the problems encountered with electrical humidification systems.

To install the HME , connect the large diameter end of the HME to your mask and the smaller diameter end to your CPAP Tube. Be sure both connections are fully seated and secure. Store the HME in a sealed plastic bag between uses to extend its life. Discard after 7 days or when it is no longer providing humidification.

Q-lite Muffler

The Q-lite is a single patient reusable accessory designed to reduce acoustic noise which may be transmitted to the patient mask through the CPAP tube. The Q-lite has standard end fittings and may be used with any standard (22mm) or slim-style (15 mm) CPAP tube. The Q-lite comes ready for use. There are no owner servicable parts to replace. When cleaning the CPAP tube , disconnect the Q-lite – do not wash.

PowerShell (Optional Accessory)

The PowerShell houses both the Z2 and the Battery which allows temporary usage of the Z2 without the Power Supply. It can be purchased at your retail medical supplier or at www.smallcpap.com.

Set Up Guide

Unpacking the Z2 Box

You will need to perform a few minor setup steps before using your new Z2. 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 Z2 to you. If you have any questions or problems as you go through the setup process, please call Breas Medical Customer Service at 1-855-436-8724 for assistance. Breas Medical wants your user experience with the Z2 to be trouble and frustration free.

1. Carefully remove the contents of the box.
2. Some of the Z2 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 7 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 Medical Customer Service at 1-855-436-8724, or your service or health care provider before use.
4. Place all the components in an area where you can easily access the Z2 for set up and programming.

WARNING: Do not use this product if you have any concerns about the condition of the contents or if there are any missing parts.

Z2 Auto – Assembling and Powering Up

Filter and End Cap

Your Z2 comes with the first filter already installed. Replacement filters may be installed as follows:

1. Remove the End Cap from the Z2. Hold the body of the Z2 in one hand. With the other hand, squeeze firmly on the sides of the End Cap and pull it down and away from the Z2.

2. Discard used Filter.

3. Remove new Filter from its packaging.

4. Insert the new Filter into the End Cap , aligning the arched side of the Filter with the top of the End Cap.
   Ensure the Filter covers all holes in the End Cap , so that all air entering the Z2 passes through the Filter and no air bypasses the Filter.

5. Press the End Cap onto the Z2. (Figure 1)

Figure 1

Tube Adapter, Q-lite, CPAP Tube, HME and Mask

1. Connect one end of the 8″ CPAP Tube to the round end of the Tube Adapter then insert the other end of the Tube Adapter into the outlet of the Z2. (Figure 2)
2. Connect the other end of the 8″ CPAP Tube to one end of the Q-lite. Connect the other end of the Q-lite to the 4′ CPAP Tube. Connect the end of the 4′ CPAP Tube to the HME and the HME to the mask. (Figure 3)
3. Ensure all connections are tight to avoid air leaks. (Figure 4)

Figure 2

Figure 3

1. 4′ Tube
2. Q-lite
3. 8″ Tube
4. Z2
5. Mask
6. HME

Figure 4

Power Supply

WARNING: The Z2 must only be used with the Breas Medical Power Supply (or the optional Breas Medical PowerShell and Battery ). DO NOT use any other power source with the Z2.

CAUTION: Make sure the AC power cord IS NOT plugged into a wall 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 Z2. (Figure 5)
4. The Z2 will power up and cycle through a series of startup displays.
5. After about 10 seconds, the Z2 will enter standby mode. The display will read 0.0. (Figure 6)

NOTE: The Z2 display will be active whenever the device is receiving power.

Figure 5

Figure 6

Using Your Z2

LCD Display

Figure 7

(1) Treatment Pressure Display
(2) Ramp Progress
(3) Ramp Time Remaining
(4) Battery Status Display (PowerShell Only)
(5) AC Power Indicator
(6) General Status Display
(7) Fault

(1) Treatment Pressure Display

The current treatment pressure is shown on the LCD display. Once set, the prescribed treatment pressure will be retained in the Z2 ’s memory even during loss of power. For example, a treatment pressure setting of 10.0 cm H2O is displayed in Figure 7.

(2) Ramp Progress & (3) 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 Z2 for Ramp Mode, the Ramp Progress and Ramp Time Remaining indicators will appear on the LCD display. For example, Figure 7 indicates that the ramp is just over half complete, with a ramp time remaining of 10 minutes.

(4) 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 7 indicates that the Battery has between 63-90% of charge remaining. Make sure the Battery is fully charged before each use. The bars will stop flashing when the charging is complete.

Number of Solid Bars

| Charge Remaining
---|---
1|

10-35%

2

| 35-63%
3|

63-90%

4

|

90-100%

(5) AC Power Indicator

This icon is displayed when the Z2 is connected to an AC power outlet via the Power Supply.

(6) General Status Display

In Standby Mode, this display field alternates between a display of the current date, the current function mode, the Z-Breathe setting and Auto Start / Stop feature. During treatment and while setting treatment parameters, this display field shows the currently selected function mode (APAP or CPAP) and Z-Breathe setting (1, 2 or 3).

The General Status Display field may also give notification of certain events which will NOT prevent the Z2 from operating normally but may need to be addressed by the user.

seconds before attempting to restart treatment again.
Fail 2| Attempt to set ramp start pressure while ramp time = 0| Set ramp time to a minimum of 5 minutes to enable the ability to set ramp start pressure.
Fail 3| Attempt to save treatment pressure while device is locked| Treatment pressure changes can only be made by a trained healthcare provider while the device is unlocked.
| Data is no longer getting logged. Therapy will continue.| Internal battery needs replacement, so the device has stopped logging data. Call Breas to arrange for the battery to be replaced. Until then therapy will continue to be provided.

(7) Fault

“FAULT” is displayed if one of several conditions has occurred that require your attention. See Fault Conditions (page 17) for explanations of the FAULT codes.

Starting and Stopping Treatment

1. Press the Start/Stop Button on the Z2 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 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 Z2 ramps up to prescribed treatment pressure. If the incorrect pressure is displayed, contact your health care provider before commencing CPAP therapy. (Figure 8) 
2. Press the Start/Stop Button a second time to stop treatment.

Figure 8

1. Current Treatment Pressure
2. Start/Stop Button

Auto Start / Stop Feature

The Z2 is equipped with an Auto Start / Stop feature. This feature will start the treatment automatically when the mask is placed on the face and you start to breathe. It will stop the treatment after the mask has been removed. To restart the treatment, place the mask back on your face and start to breathe through the mask.

The Z2 is shipped with this setting turned on. See Setting Auto Start / Stop Feature (page 14) for instructions on turning it off or on.

NOTE: The Auto Start / Stop feature will stop the therapy if a large air leak is detected between the Z2 outlet and the mask. This may also happen at times when the mask is not being worn properly. This common condition should be resolved once all connections are secure, the mask is properly worn, and the Start/ Stop Button has been pushed or you start breathing into the mask.

NOTE: The Auto Start / Stop feature may not work with the use of a full face mask due to its design. In this case you will need to press the Start/Stop Button to start the therapy.

Choosing Between Z-Breathe® settings

The Function Mode Setting is shown in the General Status Display field on the LCD. APAP mode is designated by the word “APAP” and CPAP is designated by the word “CPAP”.

NOTE: Function Modes can ONLY be set by a healthcare provider.

The Z-Breathe setting of 1-3 is indicated by the number following the CPAP designation on the LCD screen. For example CPAP-2 means the CPAP mode with a Z-Breathe setting of 2 (Figure 9) To set the Z-Breathe setting, press and hold down the Up Arrow Button and Down Arrow Button simultaneously while in the Standby mode (pressure of “0.0” indicated on the display). Once you see the Function Mode indicator flashing on the LCD screen, you can select the desired Z-Breathe setting using the Up Arrow Button and Down Arrow Button. After you have made your selection, press and hold the Start/Stop Button to save it.

 Figure 9

1. Z-Breathe Setting
2. Mode

Your selected setting for Z-Breathe will be retained in the memory of your Z2 unit after it is turned off. The currently selected Z-Breathe setting will be displayed when the Z2 is delivering treatment pressure.

Z-Breathe is a proprietary algorithm engineered in the Z2 to smooth out the breathing cycle while enjoying the benefits of CPAP treatment. Typically users experience pressure swings while breathing on a CPAP device. Pressure swings occur as a spike in pressure during exhalation and a drop in pressure during inhalation. Z-Breathe is designed to minimize the impact of spikes and drops while keeping the pressure constant, thereby delivering more comfortable therapy.

Pressure swings can vary between users due to lung capacity and other factors. For this reason we have created 3 levels of Z-Breathe to accommodate individual users’ preferences:

— 1 offers mild pressure swing relief
— 2 is the Default Setting and offers moderate pressure swing relief
— 3 is the most aggressive setting for pressure swing relief

Setting the Auto Start / Stop Feature

If you prefer to start and stop the Z2 using the Start / Stop Button , you can disable the Auto Start / Stop Feature. To do this press and hold the Up Arrow Button and Down Arrow Button at the same time until the Z-Breathe setting flashes. Release the buttons. Then press and hold the Up Arrow Button and Down Arrow Button at the same time again until flashes. Release both buttons and press the Down Arrow Button to change to . Press and hold the Start / Stop Button to save the setting. To enable the feature, repeat the steps above, but press the Up Arrow Button to change to

Programming Ramp Mode

Some users find it comforting to acclimate to therapy each session. This can be accomplished by programming the Ramp Mode which allows you to start with a low initial pressure and gradually increase to the prescribed treatment pressure.

Setting Ramp Time

When the Z2 is in standby mode, press and hold the 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 10) Set the ramp time to “00 MINUTES” to disable the Ramp Mode.

Figure 10

1. Up Arrow Button
2. Ramp Time
3. Ramp Pressure
4. Down Arrow Button

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 Z2 is not powered). The Z2 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.

NOTE: Ramp Time must be set to a minimum of 5 minutes prior to attempting to program Ramp Start Pressure or the change to Ramp Start Pressure will not take effect and “FAIL 2” will be shown in the General Status Display field.

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 H2O increment. (Figure 10) 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 Z2 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.

Z2 Auto Bluetooth Connectivity

In order for the Z2 to connect to the Nitelog® Mobile App , the Z2’s Bluetooth must be turned on. Once the Z2 has connected to the Nitelog App via Bluetooth, access between the Nitelog App and Z2 device is password protected. If the password is incorrect the Mobile App will be denied access to the Z2 device.

Immediately after plugging the Power Adapter into your Z2, hold the Up Arrow Button. “bt-On” will display on the screen to indicate your Bluetooth has been turned on. (Figure 11)

To turn off the Bluetooth capability on your Z2 (Airplane Mode), unplug the Power Adapter from your Z2. Plug your Power Adapter back into your Z2 and immediately hold down the Down Arrow Button. “bt-Off” will display on the screen to indicate your Bluetooth has been turned off. (Figure 12)

Figure 11

Figure 12

Nitelog® Bluetooth App

Your Z2 Auto has a range of functionality from device remote control to data viewing available via its embedded Bluetooth capability. The Nitelog® App is available for download at the App Store™ for Apple devices or at Google Play for Android devices. Separate Nitelog® App User Guides are available for download on the Breas Medical web site, www.breas.us. The App User Guides provide an overview of the App as well as detailed use instructions.

User Software

Breas Medical provides User Software for data viewing which may be downloaded from the Breas Medical website to any Windows computer. A separate user guide for this software is available for download at the Breas Medical website, www.breas.us.

Care

The Z2 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
• Fault Conditions

Inspections

Before each use carefully inspect the Z2 , CPAP Tube , Filter , and mask for signs of wear, damage or discoloration. Contact your retail medical supplier or at www.smallcpap.com for replacement parts.

Cleaning

Regular cleaning should be performed in accordance with the instructions below.

WARNING: This device can expose you to electrocution. Do not immerse the Z2 , 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 Z2. 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 , Q-lite and the mask from the Z2.
2. Wash the CPAP Tube in warm water using mild detergent.
3. Rinse thoroughly, hang, and allow to dry.
4. The Q-lite has no owner serviceable parts to replace. The foam inside the Q-lite has been tested and found to have no significant bacterial growth after 30 days of use in a dry environment. The use of a water-based humidifier may affect this performance. Examine the Q-lite for cracks or breaks in the plastic and replace as necessary.
5. Before next use, reconnect the Q-lite , CPAP Tube and the Tube Adapter to the Z2 and mask.

NOTE: Soaking the CPAP Tube in water for longer than 10 minutes may shorten the life of the tube.

Every 90 days

The CPAP tube should be replaced every 90 days or earlier if it becomes discolored, cracked or damaged.

CAUTION: Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the CPAP tube or Q-lite foam insert. Never attempt to clean the CPAP tube with any of these solutions. These solutions may cause damage and reduce the life of the CPAP tube.

CAUTION: Prolonged exposure to sunlight may cause the CPAP Tube to discolor and degrade

As Needed

1. Clean the exterior of the Z2 with a soft damp cloth and mild detergent and wipe clean. Never submerge the Z2 in water. Do not allow soap or water to enter the Z2.

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 Z2 uses a specially designed Filter that is only available from your retail medical supplier or at www.smallcpap.com.

WARNING: Do not attempt to use any air filter which is not supplied by Breas Medical for the Z2. The Z2 is designed to only work with approved materials. A filter which is not approved may cause damage to the Z2 from overheating.

CAUTION: Do not operate the Z2 without the Filter. The Z2 must operate with a filter installed; failure to do so may damage the Z2 and allow impurities into the respiratory system.

Fault Conditions

The Z2 has the ability to detect operational problems and will display the word FAULT on the LCD screen. (Figure 13)

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 13

The table below provides a listing of fault codes and recommended actions to be taken by the user.

your health care provider or Breas.
27 Flashing| Overheating| Let cool. Check to see if the fault code goes away. 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.

*Breas Medical Service Center at 1-855-436-8724.

USB Firmware Upgrade

Z2 firmware upgrades and instructions can be found on www.breas.us when they become available.

Troubleshooting

the power outlet has power.

Loose connection of the Power Supply at the Z2 or loose connection of the Power Cord at the AC Adapter. Check the connections.

Z2 is not locked into position in the PowerShell. Slide the Z2 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 Z2 is connected to the Z2. Remove the power supply unit and replace with a Breas Medical approved unit.

Treatment Will Not Start| Check the display for a fault condition. Refer to the Fault Codes table in “Fault Conditions”.

The Auto Start/Stop Feature may not start treatment with a full face mask due to the mask design. Use the Stop/Start Button to start treatment and turn off the feature. NOTE: Z2 is shipped with Auto Start /Stop on.

Treatment Shuts Off| Treatment automatically stops when the mask is removed or a large enough leak is detected and the Auto Start / Stop Feature is active. To restart therapy, check for leaks and reposition your mask on your face. Push the Stop/Start button or start breathing through the mask. If problem continues, check for leaks in the connections between all of the pieces between the mask and the unit. Or turn off the Auto Start / Stop Feature.
Insufficient Air Flow Delivered from Z2| 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 Z2 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 immediately.

Mask and/or headgear are not positioned correctly 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”.

Pressure Rises Inappropriately| 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.

Mask Cushion is Vibrating Against the Skin and an Air Leak is Occurring| Stop treatment. Remove and reposition the mask and, if necessary, adjust the headgear. Resume treatment.
Follow mask manufacturer’s instructions.
Z2 Has Been Left in a Hot Environment| Allow Z2 to cool before use. Disconnect the power cord and then reconnect it to restart the Z2.
Electromagnetic Compatibility| The Z2 and PowerShell meet all applicable electromagnetic compatibility standards. However, if you suspect performance of the device is affected by interference from wireless sources, move the Z2 and PowerShell further away from those sources.

Guidance and Manufacturer’s Declaration

Electromagnetic Emissions & Immunity

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.

The Z2 System does not have Essential Performance within the meaning of IEC 60601-1. However, immunity testing was conducted in accordance with IEC 60601-1-2 and compliance was confirmed as summarized in this document.

Guidance and manufacturer’s declaration – electromagnetic emissions

The Z2 Auto System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z2 System should assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment — guidance
---|---|---
RF emissions
CISPR 11| Group 1| The Z2 Auto System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11| Group B| The Z2 Auto System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2| Class A|
Voltage fluctuations/ flicker emissions
IEC 61000-3-3| Complies|

WARNINGS:

• The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
• The use of cables and accessories (eg, humidifiers) other than those specified for the device is not recommended. They may result in increased emissions or decreased immunity of the device.

Guidance and manufacturer’s declaration — electromagnetic immunity

The Z2 Auto System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z2 Auto System should assure that it is used in such an environment.

· Immunity test| IEC 60601 test level| Compliance level|

Electromagnetic environment – guidance

---|---|---|---
Electrostatic discharge (ESD)
IEC 61000-4-2| ±6 kV contact
±8 kV air| ±6 kV contact
±8 kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input/output lines| ±2 kV for power supply lines
±1 kV for input/output lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| ±1 kV line(s) to line(s)

±2 kV line(s) to earth

| ±1 kV line(s) to line(s)

±2 kV line(s) to earth

| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| <5 % UT

(>95 % dip in UT) for 0.5 cycle

40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 5 sec

| <5 % UT

(>95 % dip in UT) for 0.5 cycle

40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 5 sec

| Mains power quality should be that of a typical commercial or hospital environment, If the user of the Z2 Auto System requires continued operation during power mains interruptions, it is recommended that the Z2 Auto System be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

The Z2 Auto System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z2 Auto System should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment — guidance
---|---|---|---
Conducted RF
IEC61000-4-6
Radiated RF
IEC 61000-4-3| 3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz| 3V

3V/m

| Portable and mobile RF communications equipment should be used no closer to any part of the Z2 Auto System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance
d =1.2 √P
d =1.2 √P 80 MHz to 800 MHz
d =2.3 √P 80 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Z2 Auto System is used exceeds the applicable RF compliance level above, the Z2 Auto System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Z2 Auto System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Z2 Auto System

The Z2 Auto System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Z2 Auto System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Z2 Auto System as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

| Separation distance according to frequency of transmitter m
---|---
150 kHz to 80 MHz

d =1.2 √P

| 80 MHz to 800 MHz

d =1.2 √P

|

800 MHz to 2,5 GHz

d =2.3 √P

0.01

| 0.12| 0.12| 0.23
0.1| 0.38| 0.38|

0.73

1

| 1.2| 1.2| 2.3
10| 3.8| 3.8|

7.3

100

| 12| 12|

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

WARNINGS:
Please note that mobile RF communications equipment can affect medical electrical equipment.

Wireless Quality of Service for Z2 Bluetooth Communication with Nitelog® App

The Z2 and the Nitelog® App utilize only a very small fraction of the available bandwidth and throughput. Based on this, the Z2 and the Nitelog® 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 Z2. All functions of the Z2 can be performed on the Z2 unit itself. The Z2 Nitelog® App and Z2 are tested for coexistence with other in-band radio frequency sources. The Bluetooth hardware module is FCC listed, and complies with FCC PART 15 SUBPART C.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Technical Specifications

30W Power Adapter| Unit Input range 100–240V, 50–60Hz
Typical power consumption 20W (30VA)
Maximum power consumption 35W (70VA)
---|---
Operating temperature| 41ºF to 95ºF (5ºC to 35ºC)
Operating humidity| 10–80% Relative Humidity, Non-Condensing
Operating altitude| Sea level to 8,000 ft (2,433 m)
Operating atmospheric pressure| 101 to 75.3 kPA
Storage and transport temperature| -4ºF to +140ºF (-20ºC to +60ºC)
Storage and transport humidity| 10–95% Relative Humidity, Non-Condensing
Storage and transport altitude| No limit
Storage and transport atm. pressure| No limit
Electromagnetic compatibility| Compatible with IEC 60601-1-2
Aircraft use| Complies with RTCA DO-160G Standard for use in flight
IEC 60601-1 classification| Class II (double insulation), Type BF
Available modes| Standby, CPAP and CPAP with ramp auto-adjusting CPAP and auto-adjusting CPAP with ramp.
Deliverable pressure accuracies| ±0.6 cm H2O ± 4% of the measured reading
Sound pressure level| 26 dBA
Nominal dimensions (L x W x H)| 6.48” X 3.30” X 2.02” (16.46 cm x 8.38 cm x 5.13 cm)
Weight| 10.5 oz. (299 g)
Housing construction| Flame retardant engineered thermoplastic
Supplemental oxygen| Not for use with oxygen
Standard air filter| Polyester
Air outlet| The 22 mm air outlet complies with ISO 5356-1 Battery charges when Z2 is not in use.

Performance Specifications

Bluetooth Specifications

Panasonic Electronic Components
Bluetooth Module + BLE HCI W/ANTENNA

defined
Robustness| Adaptive frequency hopping, Lazy Acknowledgement, 24-bit CRC, 32-bit Message Integrity Check
Latency (from a non-connected state)| 6ms
Power-Output| 10dBm
Sensitivity| -93dBm
Standard| IEEE 802.15.1

Nitelog® App

Visit https://breas.us/cpap-user-guides-and-software/ for a complete list of compatible Apple and Android phones..

The following symbols may appear on your device, power supply unit, or packaging.

Refer to Manual;  type BF equipment; Class II equipment; Start/stop;
IP22 Ingress Protection (IP) Rating; Manufacturer; Date of manufacture; Batch code; Catalog number; Serial number; Direct current; Disengagement Mechanism; RX ONLY Prescription only (In US. Federal law restricts these device to sale by or on order of a physician); FCC ID FCC Identifier.

Servicing

The Z2 System is intended to provide safe and reliable operation when operated in accordance with the instructions provided by Breas Medical. Breas Medical recommends that the Z2 System be inspected and serviced by an authorized Breas Medical Service Center if there is any sign of wear or concern with Z2 function. Otherwise, service of the Z2 generally should not be required during the warranty period (see `Limited Warranty’ for details) of the device.

Limited Warranty

Breas Medical warrants that your Breas Medical product shall be free from defects in material and workmanship from the date of purchase for the period specified below.

Item|

Warranty Period

---|---
Z2 Auto device|

2 years

PowerShell|

1 year

Extended Life Battery|

6 months

Power Supply|

1 year

If product fails to perform in accordance with product specifications, Breas 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 fails under conditions of normal use, Breas Medical will repair or replace, at its option, the 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 Breas Medical to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; d) damage caused by water entering the product. Warranty claims on defective product must be made by the initial purchaser by calling Breas Medical service support at 1-855-436-8724.

THIS WARRANTY REPLACES ALL OTHER EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS 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.

BREAS MEDICAL SHALL NOT BE RESPONSIBLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES CLAIMED TO HAVE RESULTED FROM THE SALE, INSTALLATION OR USE OF ANY BREAS MEDICAL PRODUCT. SOME REGIONS OR STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

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 warranty rights, contact your local Breas Medical dealer or Breas Medical office at 1-855-436-8724.

Contact Information

Breas Medical, Inc.
16 Esquire Road
N. Billerica, MA 01862 USA
www.breas.us

Main phone (customer service): 1-855-436-8724
Service support or warranty coverage: 1-855-436-8724
Email: [email protected]

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If you are planning on using your Z2 on an airplane, please detach this letter and carry it with you.

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 accommodation 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 Z2 Auto System. The Z2 Auto 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.

• Z2 Bluetooth must be in the off (airplane mode) position similar to any other mobile device to maintain compliance

Breas Medical, Inc. • 16 Esquire Road • N. Billerica, MA 01862 • 1-855-436-8724

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Breas Medical, Inc.
N. Billerica, MA 01862
USA

Z2 Auto User Guide v1 10122021

40-0111 Rev. D

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