BREAS Z2 CPAP System Continuous Positive Airway Pressure System User Guide

BREAS Z2 CPAP System Continuous Positive Airway Pressure System

Product Information

The Z2 CPAP System is a portable device manufactured by Breas  Medical, Inc. It is designed to provide continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea (OSA) in adults weighing over 66 lbs (30 kg). The device delivers a constant flow of air pressure to keep the airways open during sleep, ensuring uninterrupted breathing and reducing the symptoms of OSA.

Owner/User Responsibility
As the owner/user of the Z2 CPAP System, it is your responsibility to read and understand the User Guide provided with the device. Familiarize yourself with the features and capabilities of the device before using it. Failure to follow the instructions in the User Guide may result in injury or damage.

Healthcare Provider Responsibility
Your healthcare provider is responsible for explaining contraindications and instructions for use to you as the patient/user. They will guide how to properly use the Z2 CPAP System and address any specific concerns or questions you may have.

Replacement Z2 Parts and Supplies
Only use genuine Z2 replacement filters, parts, and supplies with your Z2 CPAP System. Unauthorized filters, parts, or replacement supplies can potentially damage the device and void the warranty. You can purchase replacement filters, parts, and supplies from a retail medical supplier or through www.smallcpap.com.

Product Usage Instructions

Getting to Know Your Z2 CPAP System
The Z2 CPAP System comes with the following package contents:

• Z2 CPAP 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
• Filters (2 – 1 installed in Z2, 1 in box)
• Heat / Moisture Exchanger (HME)
• Q-lite Muffler
• 8 in. Slim Style CPAP Tube
• Z2 CPAP Quick Start Guide
• Z2 CPAP User Guide

Using Your Z2 CPAP System

1. Read the User Guide provided with your Z2 CPAP System thoroughly before using it.
2. Ensure that your Z2 and its accessories are dry before plugging them in.
3. Connect the power supply to the Z2 CPAP Device and plug it into a power outlet.
4. If using a computer, connect the Z2 CPAP Device via the provided USB cable.
5. Attach the appropriate CPAP tube adapter to the Z2 CPAP Device.
6. Connect one end of the CPAP tube to the tube adapter and the other end to your mask or interface.
7. Ensure that the filters are properly installed in the Z2 CPAP Device.
8. If desired, attach the Q-lite Muffler to reduce noise during operation.
9. Place the Z2 CPAP Device on a stable surface near your bed or secure it using the provided mounting options.
10. Turn on the Z2 CPAP Device according to the instructions provided in the User Guide.
11. Adjust the CPAP pressure settings as prescribed by your healthcare provider.
12. Put on your mask or interface and adjust it for a comfortable fit.
13. Lie down in a comfortable sleeping position and start your therapy session.
14. Follow the recommended cleaning and maintenance procedures outlined in the User Guide to ensure optimal performance and longevity of your Z2 CPAP System.

Please note that any adverse effects or unusual symptoms experienced during CPAP therapy should be reported to your prescribing physician.

Welcome to Your Z2 CPAP System
Thank you for choosing the Z2 CPAP 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 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 Z2 other than by 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. The 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 CPAP System is a single-user, reusable device that provides continuous positive airway pressure (CPAP) to support the 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 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 healthcare 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 that is connected to your Z2.
• If you notice any unexplained changes in the performance of your Z2 if your Z2 is making unusual or harsh sounds, or if the Z2 or Power Supply is dropped or mishandled, discontinue use and contact the Breas Medical Service Center at 1-855- 436- 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 healthcare 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 that may cause overheating.
• Do not cover the Power Supply, PowerShell, or Battery with any object or material that 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 the 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 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 according to 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 it immediately.

Getting to Know Your Z2 CPAP System

Package Contents

• Z2 CPAP 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
• Filters (2- 1 installed in Z2, 1 in box)
• Heat / Moisture Exchanger (HME)
• Q-lite Muffler
• 8 in. Slim Style CPAP Tube
• Z2 CPAP Quick Start Guide
• Z2 CPAP User Guide

Z2 CPAP 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 healthcare provider regarding the selection of tubing for your treatment. Follow the instructions provided with the tubing.

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 a 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 can also 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 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 healthcare provider before 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 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 ensure all components are present. Keep in mind that your healthcare provider might have completed some of the setup steps before 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 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 setup 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 CPAP  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 the 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)

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)

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 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.

Using Your Z2

Treatment Pressure Display
The current treatment pressure is shown on the LCD. 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.

Ramp Progress & 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. For example, Figure 7 indicates that the ramp is just over half complete, with a ramp time remaining of 10 minutes.

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.

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

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 the Auto Stop feature. During treatment and while setting treatment parameters, this display field shows the currently selected function mode (CPAP) and Z- Breathe setting (1, 2, or 3). The General Status Display field may also give notification of certain events that do NOT prevent the Z2 from operating normally but may need to be addressed by the user.

FAULT
“FAULT” is displayed if one of several conditions has occurred that require your attention. See Fault Conditions (page 16) 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 healthcare provider before commencing CPAP therapy. (Figure 8)
2. Press the Start/Stop Button a second time to stop treatment.

Auto Stop Feature
The Z2 is equipped with an Auto Stop Feature. This will stop the treatment automatically after the mask has been removed. To restart the treatment, place the mask back on your face and press the Start/Stop Button.

NOTE : The Auto 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.

Choosing Between Z-Breathe® settings
The Z-Breathe setting of 1-3 is indicated by the number following the Z-Breathe Setting the CPAP designation on the LCD screen. For example, CPAP-2 Mode 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. 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 Stop Feature

If you prefer to stop the Z2 using the Start / Stop Button, you can disable the Auto 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 CPAP therapy each session. This can be accomplished by programming the Ramp Mode which allows you to start with a low initial pressure and gradually 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.
• 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 before 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) The ramp start pressure must be lower than the 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.

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
• 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 according to 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, 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 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 servicable 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 it as neccessary.
5. Before the xt 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. 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 that is not supplied by Breas Medical for the Z2. The Z2 is designed to only work with approved materials. A filter that 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 can detect operational problems and will display the word FAULT on the LCD screen. ( Figure 11 ) 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. 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| Overpressure| Discontinue use and contact your health care provider or Breas .

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.

The battery is not locked into position in the PowerShell. Slide the Battery into the PowerShell until the Battery Shuttle clicks and locks into place.

The 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 it 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”. Contact the Breas Medical Service Center at 1-855- 436-8724
Treatment Shuts Off| Treatment automatically turns off when the mask is removed. Replace the mask and push the Stop/Start button. If the problem continues check for leaks in the connections between all of the pieces between the mask and the unit. Or turn off the Auto Stop feature.
Insufficient Air Flow Delivered from Z2| The air filter is dirty or clogged. Replace the air filter. Air intake is blocked. Clear blockage.

The CPAP Tube is not connected properly. Check the CPAP Tube, Tube Adapter, and connections to your Z2 and your mask.

Ramp Mode is in use. Wait for air pressure to reach the prescribed treatment pressure or stop treatment and adjust ramp time.

CPAP Tube is blocked, pinched, or punctured. Unblock the CPAP Tube. Check the CPAP Tube for punctures. Replace a damaged CPAP Tube immediately.

The mask and/or headgear are not positioned correctly and the mask is leaking. Adjust the position of the mask and headgear until the 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 unusually. 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 the 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 the 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 the 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 by IEC 60601-1-2 and compliance was confirmed as summarized in this document.

Guidance and manufacturer’s declaration – electromagnetic emissions
The Z2 CPAP System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z2 System should ensure that it is used in such an environment.

Emissions test| Compliance           Electromagnetic environment — guidance
---|---
RF emissions CISPR 11| Group 1| The Z2 CPAP 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

|

Class B

| The Z2 CPAP 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 of electromagnetic immunity
The Z2 CPAP System is intended for use in the electromagnetic environment specified below. The customer or the user of the Z2 CPAP System should ensure 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| ±2 kV for power| ±2 kV for power| Mains power quality
transient/burst| supply lines| supply lines| should be that of a typical
IEC 61000-4-4| ±1 kV for input/| ±1 kV for input/| commercial or hospital
 | output lines| output lines| 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| <5 % UT

(>95 % dip in UT) for 0 .5 cycle

40% UT

| <5 % UT

(>95 % dip in UT) for 0 .5 cycle

40% UT

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the Z2 CPAP System requires continued operation during power mains interruptions, it is

recommended that the Z2 CPAP System be powered from an uninterruptible power supply or a battery.

IEC 61000-4-11| (60% dip in UT) for 5 cycles| (60% dip in UT) for 5 cycles
 | 70% UT| 70% UT
 | (30% dip in UT) for 25 cycles| (30% dip in UT) for 25 cycles
 | <5% UT| <5% UT
 | (>95 % dip in UT) for 5 sec| (>95 % dip in UT) for 5 sec
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.

N O T E : UT is the .c . mains voltage before application of the test level.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment —

guidance

---|---|---|---
 |  |  | Portable and mobile RF communications equipment should be used no closer to any part of the Z2 CPAP System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
 |  |  | Recommended separation distance
Conducted RF| 3 Vrms| 3V| d =1.2 √P
IEC61000-4-6| 150 kHz to 80 MHz|  | d =1.2 √P 80 MHz to 800 MHz
Radiated RF IEC 61000-4-3| 3 V/m

80 MHz to 2.5 GHz

| 3V/m| 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,  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. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts 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 CPAP System is used exceeds the applicable RF compliance level above, the Z2 CPAP 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 CPAP 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 CPAP System

The Z2 CPAP System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Z2 CPAP System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Z2 CPAP 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 Z2 Mobile App
The Z2 and Mobile App utilize only a very small fraction of the available bandwidth and throughput. Based on this, the Z2 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 Z2. All functions of the Z2 can be performed on the Z2 unit itself. The Mobile 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
• Latency (from a non-connected state)  6ms
• Power-Output  10dBm
• Sensitivity   -93dBm
• Standard  IEEE 802 .15 .1
• Refer to Manual    type BF equipment; Class II equipment; Start/stop; Ingress Protection (IP) Rating;Manufacturer;Date of manufacture; Batch
• Storage and transport temperature -4ºF to +140ºF (-20ºC to +60ºC) code; Catalog number; Serial number; Direct current; Disengagement
• Storage and transport humidity  10–95% Relative Humidity, Non-Condensing Storage and transport altitude  No limit
• Storage and transport atm. pressure 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
• 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 .3 oz. (292 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.
• Mechanism; Prescription only (In the US . Federal law restricts this device to sale by or on order of a physician); FCC ID FCC Identifier.

Performance Specifications

• Operating pressure ranges from 4 to 20 cm H2O
• Maximum single fault steady pressure 30 cm H2O
• Pressure accuracy ±(0 .6 cm H2O + 4% of the measured reading)

Bluetooth Specifications
Panasonic Electronic Components Bluetooth Module + BLE HCI W/ANTENNA

• FCC ID  T7V1315
• FCC Compliance  FCC PART 15 SUBPART C
• Frequency 2400-2483 .5 MHz
• Modulation or Protocol Bluetooth Low Energy, V4 .0
• Over-the-air data rate  1 Mbit/s
• Application throughput  0 .27 Mbit/s
• Security 128-bit AES with Counter Mode CBC-MAC and application layer user-defined
• Robustness Adaptive frequency hopping, Lazy Acknowledge- ment, 24-bit CRC, 32-bit Message Integrity Check

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

Servicing
The Z2 System is intended to provide safe and reliable operation when operated by 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 the 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.

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

If the product fails to perform by 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 an 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 products 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 that 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 www.breas.us Main phone (customer service): 1-855-436-8724 Service support or warranty coverage : 1-855-436-8724 Email [email protected]

FAA Compliance

To whom it may concern:
The US Department of Transportation (DOT) Final Rule, “Nondiscrimination based on 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) by the current version of RTCA/DO-160, Section 21, Category M. Breas Medical has completed testing for the Z2 CPAP System. The Z2 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.

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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