Fisher and Paykel HEALTHCARE 100-199 SleepStyle Auto Cpap Machine User Guide

Use and Care Guide
F &P SleepStyle Auto

100-199 SleepStyle Auto Cpap Machine

BEFORE YOU START
Caution: USA Federal Law restricts this device to sale by or on the order of a physician.
Before the device is used for the first time, it must be set up by a healthcare provider.
If your device or any accessories are not operating correctly, please contact your healthcare provider.
Healthcare providers: please contact your Fisher & Paykel Healthcare representative for a copy of the F&P SleepStyle Clinician Guide.

OVERVIEW

WELCOME
Thank you for choosing your F&P SleepStyle device.
The F&P SleepStyle Auto is an auto-adjusting positive airway pressure device.
The F&P SleepStyle CPAP is a continuous positive airway pressure device (CPAP).
This guide refers to the F&P SleepStyle Auto and F&P SleepStyle CPAP as the “device”. The device is intended to treat Obstructive Sleep Apnea (OSA) by delivering a flow of positive airway pressure at a level prescribed by the physician, to splint open the airway and prevent airway collapse.
Please read this guide carefully before you use your device. Keep this guide in a safe place so you can refer to it later if you need to.
1.1 INTENDED USE / INDICATIONS
FOR USE
The device is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA).
The device is for use in the home or sleep laboratory.
1.2 CONTRAINDICATIONS
Warnings
Do not use this device if you have the following preexisting conditions as they may contraindicate the use of positive airway pressure:

• Pneumothorax
• Bullous lung disease
• Pneumocephalus
• Cerebrospinal fluid leak
• Recent cranial surgery or head trauma
• Abnormalities of the cribriform plate
• Pathologically low blood pressure
• Bypassed upper airways.

If you are unsure about what pre-existing conditions you have, check with your physician or healthcare provider.
1.3 WARNINGS
To avoid the risk of fire:
Do not use this device with patients requiring supplemental oxygen.
Connecting supplemental oxygen to any part of this system, either at the mask or at the device air outlet, may cause oxygen to build up in the device, and could result in a fire.
1.3.1 To avoid death or serious injury:

• The device must only be used on adult patients.
• The device must only be used for the treatment of OSA.
• The device must only be used on prescription of a physician.
• The device must not be used for life-support applications.

1.3.2 To avoid electric shock:

• Do not use if the device, power cord or accessories are damaged, deformed, or cracked.
• Do not pull on the power cord as it may become damaged.
• Do not use bleach, alcohol, or cleaners with citrus or other natural oils. These substances may degrade the device and accessories.
• Do not immerse the device in water or any other liquid.
• Do not modify the device or accessories.
• Do not take apart the device. Taking the device apart, for example by unscrewing the underside of the device, will damage pressure seals and electrical components.

1.3.3 To avoid burns:

• Do not lie on, and avoid prolonged skin contact with, the ThermoSmart™ breathing tube.
• Do not fill the water chamber with hot water as this may lead to airway burns.
• Do not introduce into or operate the device or accessories in a magnetic resonance (MR) environment as there is a risk of burns due to electromagnetic e“ects.

1.3.4 To avoid the risk of fire:

• Do not cover the ThermoSmart breathing tube as this may overheat the tube.
• Do not connect electrical accessories not approved for use with the device.
• Do not use this device with patients requiring supplemental oxygen. Connecting supplemental oxygen to any part of this system, either at the mask or at the device air outlet, may cause oxygen to build up in the device, and could result in a fire.
• Sources of oxygen must be located more than 1 m (40 in.) from the device.

1.3.5 To avoid carbon dioxide re-breathing or asphyxiation:

• Do not use masks that do not contain a vent suitable for CPAP therapy, or are not recommended by
  Fisher & Paykel Healthcare or your healthcare provider.
  Failure to use a mask or accessory that permits spontaneous breathing can cause asphyxiation.

• Remove the mask immediately if the device is powered off (including in the event of a power failure or device malfunction). The flow through the mask may be insu§cient to clear all exhaled gas.

1.3.6 To avoid choking, or inhalation of a foreign object:

• Ensure the breathing tube and power cord, including any extension cords, are correctly positioned so they will not become entangled with the body or furniture during sleep.
• Do not use the device without the recommended air filter fitted. The air filter will reduce dust or particles entering the device and breathing tube.
• Do not place the device above head height to prevent water from entering the breathing tube.
• Do not use the device with water in the water chamber if the device is being used in a moving vehicle or ship.

1.3.7 To avoid injury:

• Do not place the device above head height as the device may fall.
• Do not use breathing tubes, parts, and accessories that are not distributed for use with this device or recommended by Fisher & Paykel Healthcare.
• Do not use the breathing tubes or accessories with any other device.
•  Do not use ozone to clean this device. Residual ozone may result in adverse respiratory e“ects such as irritation of the nose, throat and lungs.

1.3.8 To avoid incorrect therapy:

• Do not cover the device or place it where the air inlet could be obstructed (such as next to curtains).

• Do not use the device adjacent to electrical equipment.

• Do not adjust the pressure. Pressure adjustments should only be made by a qualified healthcare provider.

• Refer to the mask’s Use and Care Guide prior to use to ensure correct fit of the mask. Incorrect fit of the mask may apect consistent operation of this device.

• Only clean the device and accessories according to the cleaning instructions set out in section 6 – Caring for Your Device.

• Do not clean or disinfect the ThermoSmart breathing tube with hot water. This may cause deformation of the tube and reduce therapeutic pressure.

• Use the elbow when rotating the ThermoSmart breathing tube. Incorrect handling may damage the tube.

• Do not remove the InfoUSB, or power off the device, before you see this screen when updating your prescription using InfoUSB:
  Prescription Updated
  Press any button to acknowledge and clear this message.

• Do not use ozone to clean this device. Residual ozone may result in adverse respiratory eects such as irritation of the nose, throat and lungs.

1.3.9 General:

• Only use the device within the operating ranges specified, otherwise the performance of the device could be compromised. See section 8.5 – Operating Ranges.
• Do not place any part of the device or accessories within 30 cm (12 in.) of any portable mobile radio frequency communication equipment. The device complies with the electromagnetic compatibility requirements of IEC 60601-1-2. In rare occasions where electromagnetic interference is experienced you may notice the device restarting, pressure fluctuations or the humidify being temporarily reduced which may temporarily interrupt the therapy. If such interference should occur, try moving your device or the equipment causing the interference further away. Alternatively, consult your healthcare provider.
• Interference caused by common RF emitters such as diathermy, electrocautery, RFID and security systems may impact the SleepStyle device. This should be taken into consideration before placing the device in the presence of any RF emitters. The SleepStyle device has not been tested in such environments.
• Refer to the Product Technical Guide (613471) for compliance information related to EMC.
• Do not use accessories or power cables which are not provided, or recommended, by Fisher & Paykel Healthcare. This could result in increased electromagnetic emissions or decreased electromagnetic immunity.
• California residents please be advised of the following, pursuant to Proposition 65: This product contains chemicals known to the State of California to cause cancer, birth defects and other reproductive harm. For©more information, please visit: www.fphcare.com/prop65.
• This device is not repairable and does not contain any repairable parts. Please refer queries relating to the device or accessories to your healthcare provider.
• Do not administer drugs or medications into the device or breathing tube.1.3.9 General:
• Only use the device within the operating ranges specified, otherwise the performance of the device could be compromised. See section 8.5 – Operating Ranges.
• Do not place any part of the device or accessories within 30 cm (12 in.) of any portable mobile radio frequency communication equipment. The device complies with the electromagnetic compatibility requirements of IEC 60601-1-2. In rare occasions where electromagnetic interference is experienced you may notice the device restarting, pressure fluctuations or the humidify being temporarily reduced which may temporarily interrupt the therapy. If such interference should occur, try moving your device or the equipment causing the interference further away. Alternatively, consult your healthcare provider.
• Interference caused by common RF emitters such as diathermy, electrocautery, RFID and security systems may impact the SleepStyle device. This should be taken into consideration before placing the device in the presence of any RF emitters. The SleepStyle device has not been tested in such environments.
• Refer to the Product Technical Guide (613471) for compliance information related to EMC.
• Do not use accessories or power cables which are not provided, or recommended, by Fisher & Paykel Healthcare. This could result in increased electromagnetic emissions or decreased electromagnetic immunity.
• California residents please be advised of the following, pursuant to Proposition 65: This product contains chemicals known to the State of California to cause cancer, birth defects and other reproductive harm. For©more information, please visit: www.fphcare.com/prop65.
• This device is not repairable and does not contain any repairable parts. Please refer queries relating to the device or accessories to your healthcare provider.
• Do not administer drugs or medications into the device or breathing tube.

1.4 CAUTIONS
1.4.1 To prevent water damage to the device:

• Do not use if the water chamber is damaged.
• Do not fill the chamber housing with water. Only place water in the water chamber.
• Do not fill the water chamber above the maximum water-level line.
• Replace water before each use.
• Do not use the device without the chamber seal fitted to the water chamber.
• Do not fill the water chamber while it is in the device.
• Empty the water chamber before transporting or packing the device.
• Do not use the device with an empty water chamber unless the humidity level is set to 0.
• Do not add aromatic-based or scented oils to the water chamber as these oils can cause damage to the device.

1.4.2 General:

• Changes or modifications not expressly approved by Fisher & Paykel Healthcare voids the user’s authority to operate the device.
• Position the device so the power cord connection to the power supply is easily accessible and able to be disconnected.
• Do not use USB drives with the device which are not provided by Fisher & Paykel Healthcare. Use of USB drives other than the InfoUSB may cause data corruption. Do not attempt to change the directories or view the data without software distributed or designed for use with the device.
• Replace the device and accessories if there are any signs of cracking, deformation, discoloration or leaking. It is recommended that you inspect the device, breathing tube, water chamber, chamber seal, outlet seal, air filter and elbow, on a regular basis after cleaning. See section 6.4 – Replacement Parts.
• Use distilled water to reduce residue build-up on the chamber base. This will extend the life of your water chamber.
• Do not use ozone to clean the device as it can degrade the device and its accessories.

1.5 PRECAUTIONS

• The safety and efectiveness of the continuous positive airway pressure (CPAP) device has not been established in patients with respiratory failure or chronic obstructive pulmonary disease (COPD).

• The safety and efectiveness of the auto-adjusting positive airway pressure device has not been established in patients with congestive heart failure, obesity hypoventilation syndrome, or central sleep apnea.
  1.6 ADVERSE EFFECTS

• Nosebleeds, perforated ear drum, dryness of the nasopharynx, sinus infection, and middle ear infection may occur from the use of positive airway pressure therapy.

• Do not use ozone to clean the device as it can degrade the device and its accessories.

GETTING STARTED

2.1 DEVICE AND ACCESSORIES

• 1 x Carry bag
• 1 x SleepStyle device
• 1 x Breathing tube
• 1 x Power cord
• 1 x F&P SleepStyle Use and Care Guide
• 1 x F&P SleepStyle Quick Reference Guide
• 1 x Water chamber
• 1 x Chamber seal
• 1 x Outlet seal
• 1 x F&P InfoUSB (already in InfoUSB port)
• 1 x Air filter (already in the device)
• 1 x Spare air filter
• 1 x Spare elbow (for use with a standard breathing tube)

2.2 SETTING UP YOUR DEVICE

1. Place the device below head height on a stable and level surface, like a bedside table. Warnings
   To avoid injury, choking, or inhalation of a foreign object: Do not place the device above head height to prevent water from entering the breathing tube.

2. Connect the power cord and the breathing tube.
   Connect the power cord into the power inlet of the device. Connect the other end of the power cord into a power outlet. Warnings
   To avoid electric shock:
   Do not use if the device, power cord, or accessories are damaged, deformed or cracked.
   To avoid choking, or inhalation of a foreign object:
   Ensure the breathing tube and power cord, including any extension cords, are correctly positioned so they will not become entangled with the body or furniture during sleep.
   Breathing tube
   Connect your breathing tube into the air outlet. Note: Make sure the connectors on the ThermoSmart breathing tube click into position with the ThermoSmart connection.
   If you have connected the ThermoSmart breathing tube correctly, the ThermoSmart icon will appear on your home screen.
   Warnings
   To avoid incorrect therapy:
   Use the elbow when rotating the ThermoSmart breathing tube. Incorrect handling may damage the tube.

3. Remove the water chamber from the device.
   Press the lid latch and open the device lid. Take the water chamber out of the device.

4. Fill the water chamber with water.
   Peel back the chamber seal on the left-hand side of the  water chamber. Fill the water chamber with water up tothe maximum water-level line, as indicated on the side and inside of the water chamber.

Warnings
To avoid burns:
Do not fill the water chamber with hot water as this may lead to airway burns.
Cautions
To prevent water damage to the device:

• Do not use if the water chamber is damaged.
• Do not fill the chamber housing with water. Only place water in the water chamber.
• Do not fill the water chamber above the maximum water-level line.
• Replace water before each use.
• Do not fill the water chamber while it is in the device.
• Do not use the device with an empty water chamber unless the humidity level is set to 0.
• Do not add aromatic-based or scented oils to the water chamber as these oils can cause damage to the device.

General:
Use distilled water to reduce residue build-up on the chamber base. This will extend the life of your water chamber.
Secure the chamber seal.
Unfold the chamber seal back onto the water chamber. Push down in the finger holds to secure it in place. Cautions
To prevent water damage to the device:
Do not use the device without the chamber seal fitted to the water chamber.
Put the water chamber back into the device.
Place the water chamber back into the device. Push the device lid down until the lid latch clicks into position. Connect the mask to the breathing tube.
Holding the mask and the other end of the breathing tube, connect the mask swivel firmly into the breathing tube.

USING YOUR DEVICE

3.1 SCREEN ICONS
When your device is plugged in and switched on, you will see the home screen appear with up to four icons. These icons indicate the status of a setting or accessory, as follows:
*ThermoSmart Icon
Indicates that the ThermoSmart breathing tube is connected and working correctly
InfoUSB Icon**
Indicates that the F&P InfoUSB is connected and working correctly

Bluetooth® Icon
Indicates that Bluetooth technology is turned “ON” on your device and is working correctly
**Modem Icon*
Indicates that modem is turned “ON” on your device and is working correctly
Note:** If there is a line through one of these icons, or if there is a gap where an icon usually appears, refer to section 9.1 – Device troubleshooting for more information.

• Not available in all models.
  3.2 DEVICE CONTROLS

3.3 STARTING THERAPY

1. Fit your mask.
   Note: Refer to your mask’s user instructions for more information on how to fit and remove your mask.

2. Press Start/Stop to begin therapy.
   The screen below will appear:

3.4 STOPPING THERAPY

1. Press Start/Stop to stop therapy.
   Note: To reduce condensation, please keep the device plugged in and switched on at the power supply after topping therapy.
   The screen below will appear: Your device will then scroll through your therapy data screens. See section 4.1.1 – Therapy Data for more information on these screens.

2. Remove your mask.

3.5 STAND-BY MODE
The device will enter stand-by mode after 30 seconds if no button has been pressed on the device.
The display screen light will dim but will still be visible to show that your device is still powered on.
Press Down , Up , OK , or Menu to wake up the device.
3.6 COMFORT SETTINGS
3.6.1 Ramp
Ramp works by gradually increasing to your prescribed pressure over a 20-minute period.
To start Ramp:
Press and hold Start/Stop for 3 seconds until the Ramp symbol appears on the display screen: If you need to restart Ramp, press and hold Start/Stop for 3 seconds. 3.6.2 Humidity
Humidification is the process by which moisture is added to the air you breathe.
You can set the humidity level from 0 (all droplets are transparent) to 7 (all droplets are shaded). To use humidity, you will need to fill your water chamber with water and ensure the humidity level is at least 1 (one droplet shaded).
To adjust humidity at any time:

1. Press Up , OK , or
2. Press Down or Up to change the level of humidity.

The device will save your changes and time out after a period of no interaction. Alternatively, you can exit this setting by pressing Menu until you reach the previous screen.
Note: The default humidity level is 5. If using without  a water chamber, or where low power consumption is required, set the humidity level to 0.
3.6.3 Expiratory relief
Expiratory relief reduces the pressure when you breathe out, and returns to your prescribed pressure when you breathe in.
How to set the expiratory relief level:

1. Press Menu to scroll to the “Expiratory relief”’ setting.
2. Press Down or Up to change the level of expiratory relief:
   • Off (no circles shaded)
   • Low (1 circle shaded)
   • Medium (2 circles shaded)
   • High (3 circles shaded).

Note: Expiratory relief may be restricted by your healthcare provider.
3.6.4 SensAwake™
We all experience subconscious waking during the night. When this happens, SensAwake will provide pressure relief to help ease your return to sleep.
How to turn SensAwake on or off:

1. Press Menu to scroll to the “SensAwake” setting.
2. Press Down or Up   to move between “ON” and “OFF”.
   Note: SensAwake may be restricted by your healthcare provider.

VIEWING YOUR THERAPY DATA

4.1 VIEW YOUR THERAPY DATA ON YOUR DEVICE
Your device records your therapy data for the last night, last 7 days, and last 30 days, which you can view at any time.
How to view your therapy data on your device:

1. Press Menu to scroll to “My Data”.

2. Press Down   or Up to move between the following options:
   • “D” – Day (last night’s therapy data)
   • “W” – Week (average over the last 7 days of therapy data)
   • “M” – Month (average over the last 30 days of therapy data).

3. Press OK to view the range of therapy data you would like see.

The device will automatically scroll through the following therapy data:
Note: If you would like to bypass this automated scrolling, press Menu to scroll through the data screens manually.
4.1.1 Therapy Data:
THERAPY HOURS Day View: Displays the number of hours that you used your device last night.
Week View: Displays the average number of hours that you used your device over the last 7 days.
Month View: Displays the average number of hours that you used your device over the last 30 days.
MASK LEAK Day View: Indicates whether the leak from your mask last night was “NORMAL” or “HIGH”.
Week View: Indicates whether, on average, the leak from
your mask was “NORMAL” or “HIGH” over the last 7 days.
Month View: Indicates whether, on average, the leak from your mask was “NORMAL” or “HIGH” over the last 30 days.
Apnea Hypopnea Index – (AHI) Day View: Displays the average number of airway breathing events you had per hour last night.
Week View: Displays the average number of airway breathing events you had over the last 7 days.
Month View: Displays the average number of airway breathing events you had over the last 30 days.
Note:

• The AHI screen may be restricted by your healthcare provider.
• The device reported AHI is not equivalent to an AASM (American Academy of Sleep Medicine) AHI and therefore should not be used for diagnosis of OSA or in isolation for titration or clinical management.

4.2 VIEW YOUR THERAPY DATA ON THE SLEEPSTYLE APP OR WEBSITE
Your SleepStyle device allows you to view your therapy data on the SleepStyle App or website. The SleepStyle App uses Bluetooth wireless technology to communicate with your device.
The SleepStyle App is compatible with iPhone and Android. You can download the SleepStyle App, available on the Apple App Store or on Google Play™ for Android™.

• Not available in all countries.
  To pair your SleepStyle device to your mobile device, follow these steps:

  1. Turn on your SleepStyle device. The device will remain discoverable for a period of 15 minutes. Make sure your mobile device is within range.
     Note: Changing the SleepStyle device’s Bluetooth setting to “ON” will also make it discoverable for 15 minutes. See below for instructions on how to change your Bluetooth setting.

  2.  Open your mobile device’s Settings menu and turn on the Bluetooth setting.
     Note: You might need to refer to your mobile phone’s user manual for specific instructions on how to turn on the Bluetooth setting.

  3.  Open the SleepStyle App and follow the instructions on how to register an account.

  4. Follow the instructions in the app on how to pair your mobile device with your SleepStyle device.
     Your devices should now be paired. The SleepStyle App will stay up to date with daily therapy data from your SleepStyle device as long as the Bluetooth setting is turned on for both devices.
     You only need to do the pairing once. After you have paired your SleepStyle device to your mobile device, it will stay paired and will re-connect automatically until you choose to unpair them.
     Should you have any problems pairing your SleepStyle device to your mobile device, try turning your Bluetooth setting of and on again on your mobile device. If the problem continues, try turning your Bluetooth setting off and on again on your SleepStyle device (see below). For more information, visit fpsleepstyle.com.

How to change your Bluetooth setting:
If the Bluetooth setting is “OFF” on your device, there will be a line through the Bluetooth icon on your home screen.
To change your Bluetooth setting, follow these steps:

1. From the home screen, hold Menu for 5 seconds.
2. Press Menu to scroll to the ‘Bluetooth’ setting.
3. Press Down  or Up   to change the setting. Your selection will flash to confirm your selection.

UPLOADING YOUR THERAPY DATA

5.1 MODEM
If your SleepStyle device has a cellular modem, therapy data will automatically upload to your healthcare provider.
This will occur as long as your SleepStyle device is plugged in and switched on at the wall. Only your healthcare provider has access to this data.
Note: The modem is not available in all models. To identify whether your SleepStyle device has a modem, look for the modem icon   on the front of your device. If your device has a modem, and modem is turned on, ensure that the device is placed at least 20 cm (8 in.) away from your body while in use.
How to change the modem setting:
Your modem should remain “ON” so that your therapy data will upload to your healthcare provider.
If you need to change your modem setting, follow these steps:

1. From the home screen, hold Menu for 5 seconds.
2. Press Menu to scroll through the screens until you reach the “Cellular Modem” setting.
3. Press Down or Up to change the setting. Your selection will flash to confirm your selection.

If you have turned the modem “OFF”, it will turn back on automatically after 3 days.
5.2 F &P INFOUSB™
The InfoUSB automatically stores your therapy data. To ensure your therapy data is recorded to the InfoUSB, you will need to make sure that the InfoUSB is in the InfoUSB port.
If the InfoUSB is connected correctly, the InfoUSB icon will appear on the device home screen.
You can remove the InfoUSB from the InfoUSB port if requested by your healthcare provider. You can then upload your therapy data, or take your InfoUSB with you when you visit them next, or post the InfoUSB to them.
If your healthcare provider updates your prescription or device settings on the InfoUSB, these changes will automatically transfer to your device when the InfoUSB is next inserted into the InfoUSB port.
Note: The InfoUSB icon will not appear on the display screen while it is in stand-by mode. To check that the InfoUSB is connected correctly, press any button to wake up the device. You should see the InfoUSB icon on screen.
Cautions
General:
Only use the InfoUSB with the device. Use of any other USB drives may cause data corruption. Do not attempt to change the directories or view the data without software distributed or designed for use with the device.
5.2.1 SleepStyle website
You can easily upload your therapy data for viewing on the SleepStyle website. This information will also be accessible by your healthcare provider.

1. Visit fpsleepstyle.com
   On the registration page, enter your name, email address and date of birth, then click “Register”. You will be required to validate your email address and create a password before entering the website. If you have already registered in the SleepStyle App on your mobile device, you can use your email and password to log into the SleepStyle website.
   Select the option to link your device. You may be asked to download a plug-in. This allows the SleepStyle website to upload data from your InfoUSB stick.

2. Insert the InfoUSB into a computer’s USB port Remove the InfoUSB from your device and insert it into the USB port of a computer. A small light illuminates when connected to your computer. If the light does not illuminate, please turn the InfoUSB around or make sure that it is inserted fully into the USB port. Note: To avoid getting computer viruses on the InfoUSB, keep your computer’s anti-virus software up-to-date and do not use the InfoUSB to transfer and store files from your computer.

3. Follow the on-screen steps to complete linking your device
   Your therapy data on your InfoUSB will be uploaded to the SleepStyle website and can be viewed in the “My Data” page. Your healthcare provider will also be able to view this data, if they require it.

5.2.2 InfoUSB application
The InfoUSB application allows you to upload your therapy data to your healthcare provider in 5 easy steps.

1. Insert the InfoUSB into a computer’s USB port, as above

2.  Install InfoUSB application
   From the Mac App Store
   Launch the Mac App Store and search for the InfoUSB app.
   Install this free application. Upon successful installation, open Launchpad and then open the InfoUSB app.
   Note: A Mac running OS X 10.8 or later with a USB port and an internet connection are required.
   From the Windows® Store
   Launch the Windows Store and search for the InfoUSB app.
   Install this free application. Upon successful installation, open the app.
   Note: A PC or tablet running on Windows 8 or later with a USB port and an Internet connection are required.
   From the InfoUSB
   If you cannot access the Windows Store, click on the Start button and open “My Computer”. Navigate to the drive
   called “FPHCARE”. Open this folder and double-click on the Setup.exe file. Follow the on-screen instructions.
   Note: A PC running a Windows operating system with a USB port and an internet connection are required.

3. Data transfer
   Upon detection of an InfoUSB in your computer, you will be asked to enter your Date of Birth. Enter your Date of Birth and select the Upload button. Ensure that your computer is connected to the internet for successful data transfer to your healthcare provider.

4. Confirmation
   After the data has been sent successfully, a confirmation message will appear. If your prescription is updated, you will also see the message “Your healthcare provider has updated your prescription.”

5. Future data transfer
   Remove the InfoUSB from your computer and place it back into the InfoUSB port of your device. You can now use your device.
   The next time you need to upload your therapy data to your healthcare provider, simply insert the InfoUSB into your computer. The message in Step 3 above will automatically appear.

CARING FOR YOUR DEVICE

6.1 DISASSEMBLY FOR CLEANING BREATHING TUBE

1. Hold the elbow of your breathing tube and gently pull it away from the device.
2. Hold both the mask end of the tube and the mask swivel and gently pull them apart.

WATER CHAMBER AND CHAMBER SEAL

1. Press the lid latch and open the device lid.
2. Take the water chamber out of the device.
3. Remove the chamber seal from the top of the water chamber and put aside.
4. Lift the tab on the side of the water chamber and lift the chamber lid to open.

OUTLET SEAL

1. Grip the outlet seal tab.
2. Gently pull the outlet seal out of the device.

6.2 CLEANING YOUR DEVICE AND ACCESSORIES AT HOME
Cleaning your device and accessories can help extend their life and ensure that you continue to receive efective therapy. Below is information on when and how to clean the device and accessories. Refer to your mask’s user instructions on how to clean your mask.
Warnings
To avoid electric shock:
Do not use bleach, alcohol, or cleaners with citrus or other natural oils. These substances may degrade the device and accessories.
To avoid incorrect therapy:
Only clean the device and accessories according to the cleaning instructions below.
To avoid adverse efects:
Do not use ozone to clean this device. Residual ozone may result in adverse respiratory efects such as irritation of the nose, throat and lungs
Cautions
General:
Replace the device and accessories if there is any sign of cracking, deformation, discoloration or leaking. It is recommended that you inspect the device, breathing tube, water chamber, chamber seal, outlet seal, air filter and elbow, on a regular basis after cleaning. See section
6.4 – Replacement Parts.
Do not use ozone as it can degrade the device and accessories.
6.2.1 Wash after each use
The following accessories should be cleaned after each use:

• Breathing tube
• Water chamber
• Chamber seal.

Warnings
To avoid incorrect therapy:
Do not clean or disinfect the ThermoSmart breathing tube with hot water. This may cause deformation of the tube and reduce therapeutic pressure.

1. Hand-wash the elbow, water chamber, chamber seal and breathing tube in a tub of warm, soapy water with a mild dishwashing detergent. Ensure that all visible soil is removed.
2. Rinse the elbow, water chamber, chamber seal and breathing tube thoroughly in a tub of clean water for 30 seconds. Ensure that all soap residue has been removed.
3. Repeat the rinsing process again, using clean water.
4. Hang the breathing tube, with both ends pointing to the floor, to dry away from direct sunlight or heat e.g. heated towel rails.
5. Leave the water chamber and chamber seal to dry out of direct sunlight or heat.

Note: The elbow and the standard breathing tube need to be separated when washing after each use. If dirt remains inside the breathing tube after rinsing, use a soft, nonmetallic brush to remove it. Rinse the tube again. If the dirt cannot be removed, the breathing tube should be replaced.
The use of distilled water is recommended during therapy to reduce mineral deposits and stains. Should mineral deposits occur, you can reduce these by soaking the water chamber for 10 minutes in a solution of 1 part white vinegar to 2 parts water. Empty the solution and rinse thoroughly with clean water. Repeat the rinsing process again, using clean water. Leave to dry out of direct sunlight or heat before reassembling.
6.2.2 After 7 days’ use
The device and accessories below should be washed after 7 days’ use:

• Outlet seal
• Elbow
•  Device.

Outlet seal and elbow

1. Disconnect the elbow from the standard breathing tube.
2. Hand-wash the outlet seal and elbow in a tub of warm, soapy water with a mild dishwashing detergent. Ensure that all visible soil is removed.
3. Rinse the outlet seal and elbow thoroughly in a tub of clean water for 30 seconds. Ensure that all soap residue has been removed.
4. Repeat the rinsing process again, using clean water.
5. Leave to dry out of direct sunlight or heat.
6. econnect the elbow to the standard breathing tube.

Device

1. Turn the device off at the power supply, then remove the power cord from the rear of the device.
2. Wipe the exterior and chamber housing of the device with a clean, damp (not dripping wet) cloth and warm, soapy water using a mild dishwashing detergent.
3. Leave to dry out of direct sunlight or heat.

Warnings
To avoid electric shock:

• Do not pull on the power cord as it may become damaged.
• Do not immerse the device in water or any other liquid.

Dishwashing
Once every 7 days, you can clean the water chamber, chamber seal, and outlet seal in a domestic dishwasher.
Place the water chamber on the top shelf of the dishwasher and ensure the chamber seal and outlet seal are placed in a secure location.
6.3 REASSEMBLY OF THE DEVICE
Once the parts you have cleaned are dry, you can reassemble the parts.
BREATHING TUBE

1. Hold the elbow end of the breathing tube and push it into the air outlet of the device.
   Note: If you have a ThermoSmart breathing tube, make sure the electrical connectors on the elbow click into position with the ThermoSmart connection.

2.  Holding the mask and the other end of the breathing tube, push the mask swivel firmly into the breathing tube.

OUTLET SEAL
Hold the tab on the outlet seal and push it into the chamber housing inlet. Ensure the tab is sitting flat against the wall of the chamber. WATER CHAMBER AND CHAMBER SEAL

1. Close the chamber lid. Press the water chamber tab down until it clicks into place.
2. Fill the water chamber with water through either of the filling holes in the top.
3. Secure the chamber seal back onto the water chamber. Ensure it is sitting flat and seals the holes on the chamber lid.
4. Place the water chamber back into the device.

6.4 REPLACEMENT PARTS
Below is a list of replacement parts that are available.
Contact your healthcare provider to order these.

• Applied Parts – to fit 22 mm (0.86 in.) Conical Connector.
  Warnings
  To avoid injury:
  Do not use breathing tubes, parts, and accessories  that are not distributed for use with this device or  recommended by Fisher & Paykel Healthcare. General:
  Do not use accessories or power cables which are not provided, or recommended, by Fisher & Paykel Healthcare. This could result in increased electromagnetic emissions or decreased electromagnetic immunity.
  6.4.1 Air filter
  The air filter is located at the rear of the device. Replace the air filter at least once every 3 months, or more frequently if it becomes blocked with dirt or dust. To replace the air filter, please follow the instructions below.
  Warnings
  To avoid choking, or inhalation of a foreign object: Do not use the device without the recommended air filter fitted. This will reduce dust or particles entering the device and breathing tube.

  1. To remove, pinch the air filter with your fingers and pull it out of the device.
  2. Hold onto the short side of the new air filter. Push into the device so there are no gaps.

TRAVELING WITH YOUR DEVICE

The device has a universal voltage feature that allows it to operate on any domestic AC mains voltage. With the use of the appropriate pin/plug adapter the device can operate in most countries.
Below is a checklist of what to take with you when you travel:

• Carry bag
• SleepStyle device
• Water chamber (empty)
•  Chamber seal
• ThermoSmart breathing tube or standard breathing tube with elbow
• F&P InfoUSB
• Power cord
• Air filter
• Outlet seal
• F&P SleepStyle Use and Care Guide
• Mask

You may also need:

• Extension cord
• Plug adapter

Cautions
To prevent water damage to the device:
Empty the water chamber before transporting or packing.
Note: The device is not certified for use on an aircraft.
Confirm with your airline whether you can take the device with you as carry-on luggage.

SPECIFICATIONS

8.1 SLEEPSTYLE DEVICE MODELS AND FEATURES

Performance features

Fully integrated humidifier*| Leak compensation
ThermoSmart technology*| Efficacy reporting
Auto-adjusting pressure†| Compliance reporting
SensAwake| F&P InfoUSB
Expiratory relief| Bluetooth wireless technology
Ramp| Cellular modem
Auto-altitude adjustment|

Compatible with

• F&P SleepStyle App and Web
• Not available in all models.
• The ThermoSmart Breathing Tube is required to activate ThermoSmart.
• SleepStyle Auto only.
• Not available in all countries.

8.2 SYMBOL DEFINITIONS

| For safety reasons, refer to the instructions for use
---|---
Caution
Consult instructions for use
Do not use this device with patients requiring supplemental oxygen
Fill with water here
Maximum water level (do not fill above the water line)
Manufacturer
Date of manufacture
| Serial number
---|---
Batch code
Catalogue number
Humidity range
Temperature range
Protected against ingress of small objects and water drops
Do not use if package is damaged
Regulatory Compliance Mark
| Date of shelf life expiry
---|---
Type BF applied part
Non-ionizing electromagnetic radiation
Class II equipment
| Prescription only
---|---
UL Classified mark
Do not discard as regular waste
MR unsafe

8.3 PRODUCT SPECIFICATIONS

Packed Weight (max.): 2.7 kg (5.9 lb)
Performance| Pressure Range:
4 to 20 cmH,O/hPa (in the unlikely event of fault conditions, pressure limited to <30 cmH,O)
Maximum flow rates

CPAP pressure setting (cmH,O)| 4| 8| 12| 16| 20
Measured flow at patient connection port (L/min)| >145| >150| >150| >135| >120
**Dynamic pressure stability***

| BPM‘| Test pressure
4.0 cmH,O| 8.0 cmH,O| 12.0 cmH,O| 16.0 cmH,O| 20.0 cmH,O
Dynamic pressure stability (cmH,O)| 10| ± 0.5| ± 0.8
15
20

BPM – Breaths Per Minute

**Static pressure stability***

| Auto-adjusting and fixed pressure
Pressure change (cmH,O) at connection port at a pressure setting of 10 cmH,O| ± 0.5

*Pressure measurement including uncertainty: ± (0.04 cmH£O + 0.026% of reading)
The pneumatic flow path:

1. Air inlet filter
2. Ambient temperature sensor
3. Flow sensor
4. Blower
5. Relative humidity sensor
6. Pressure sensor
7. Water chamber
8.  Heater plate
9. Heater plate temperature sensor
10. Control system
11. Breathing tube
12. Mask

With Standard breathing tube4
Humidity level 7| >23| >20
Humidity level 6| >21| >18
Humidity level 5 (Default)| >18| >15
Humidity level 4| >17| >14
Humidity level 3| >15| >13
Humidity level 2| >13| >10
Humidity Level 1| >10| >10

ª AH – Absolute Humidity
« BTPS – Body Temperature Pressure Saturated
4 ISO 8185 – Minimum ambient temperature to achieve the ISO 8185 recommended humidity >10 mgH£O/L BTPS is 12 °C (54 °F)

Expiratory Relief

Expiratory relief level| Pressure reduced during expiration (cmH,O)
Off| 0 cmH,O
Low| 1 cmH,O
Medium| 2 cmH,O
High| 3 cmH,O
Electrical ratings

Rated supply voltage| Rated current input| Rated supply frequency
100–115 V| 1.2 A (2.5 A max.)| 50–60 Hz
220–240 V| 1.1 A (2.3 A max.)| 50–60 Hz
Outlet air temperature| Maximum = 38 °C (100 °F)
---|---
Noise level| Sound pressure level 28 ±1.5 dBA; average sound power level <35 dBA.
Water chamber volume| 380 mL up to the maximum water-level line
Standards compliance| IEC 60601-1:2012; IEC 60601-1-2:2014; IEC 60601-1-2:2007; IEC 60601-1-11:2015;
ISO 80601-2-70:2015; ISO 5356-1:2004; ISO 17510-1:2007; ISO 8185:2007
Cellular modem

(Country and carrier dependent)

| UMTS 3G: B1, B2, B5, B6, B8, B19; Maximum power +23 dBm
GSM 2G: 850 MHz /900 MHz /1800 MHz /1900 MHz; Maximum power +33 dBm
Bluetooth technology| 2402 – 2480MHz; Maximum power +6 dBm, GFSK, π/4-DQPSK, 8DPSK
FCC compliance| This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television reception, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
•  Reposition or relocate the receiving antenna.
•  Increase the separation between the device and receiver.
•  Connect the device into an outlet on a circuit different from that to which the receiver is connected.
•  Consult your healthcare provider or your Fisher & Paykel Healthcare representative for help.
Data recording| The InfoUSB will store up to 5 years of summary efficacy data, 365 days of detailed efficacy data, and 140 hours of high-resolution pressure, leak and flow data. Without an InfoUSB, the device’s internal memory is capable of storing up to 1 year of summary efficacy data, 30 days of detailed efficacy data, and 20 hours of high-resolution pressure, leak, and flow data.
Service life| Device| 5 years
Breathing tubes| 12 months
Water chamber| 12 months
Air filter| 3 months
General| The patient is an intended operator.

8.4 CLASSIFICATIONS

8.5 OPERATING RANGES

°F)
Ambient Humidity| 15 to 90% RH
Altitude| 0 to 3,000 m (0 to 9,000 ft.)

Maximum humidity output specification may not be maintained across the extended operating range for the standard breathing tube.
Cautions
General:
Only use the device within the operating ranges specified, otherwise the performance of the device could be compromised.
Note: Above 1,500 m (4,500 ft.) the maximum operating pressure will be reduced at high flow rates.
8.6 STORAGE AND TRANSPORT CONDITIONS
The device should always be stored and transported within the following temperatures and humidity ranges.

Note: The device is immediately suitable for use if transported and stored according to the specified storage and transport conditions.
8.7 DISPOSAL INSTRUCTIONS
Device disposal instructions
This device contains electronics and a lithium battery. Please do not discard as regular waste.
Dispose of electronics and lithium battery according to local guidelines.
Accessory and spare part disposal instructions
Dispose of breathing tube, water chamber, and other spare parts according to local guidelines.
Place the breathing tube, and water chamber in a waste bag at the end of use and discard with normal waste.
8.8 SERVICING
Warnings
General:
This device is not repairable and does not contain any repairable parts. Please refer queries relating to the device or accessories to your healthcare provider.
The device does not require preventative maintenance.
8.9 WARRANTY STATEMENT
Fisher & Paykel Healthcare warrants that the device (excluding consumable items forming part of the CPAP delivery system), when used in accordance with the instructions for use, shall be free from defects in workmanship and materials and will perform in accordance with Fisher & Paykel Healthcare’s o§cial published product specifications for a period of 2 years from the date of purchase by the end-user. This warranty is subject to the limitations and exceptions set out in detail here: www.fphcare.com/sleep-apnea/cpap-devices /warranty-cpap/

TROUBLESHOOTING

If you feel that your device is not operating correctly, please refer to the following suggestions. If the problem persists, please consult your healthcare provider. Do not attempt to repair the device yourself.
Warnings
To avoid electric shock:

• Do not modify the device or accessories.
• Do not take apart the device. Taking the device apart, for example by unscrewing the underside of the device, will damage pressure seals and electrical components.

**9.1 DEVICE TROUBLESHOOTING***

The power cord may not be plugged in correctly.

Solution: Push the power cord connector firmly to confirm it is inserted correctly into the power supply and into the rear of the device.

Has there been a storm, power outage, or power surge?
Solution: Check your circuit breaker or fuse, and reset as required. If the display screen does not turn on, return the device to your healthcare provider.
My therapy won’t start, but there is a display on the display screen.| There may be water in the blower, preventing it from starting.
Solution: Turn off at the power supply and unplug the device. Remove the water chamber. Keep the device lid open and tip the device upside down to clear the water from the device. Place the water chamber back in the device. Restart the device.
Is there an error message on the display?
Solution: Refer to section 9.2 – Error messages on SleepStyle screen.
The pressure is fluctuating or insufficient air is being delivered from the device| Your mask may not be fitted correctly, causing leaks.
Solution: Ensure your mask is correctly fitted. Refer to your mask’s user instructions for fitting instructions, or contact your healthcare provider.
Solution: The delivered pressure may fluctuate due to Electromagnetic Interference (EMI). If fluctuations continue to occur, ensure there is sufficient space between the SleepStyle device and other electrical devices that may cause interference.
There may be water in the breathing tube.

Solution: Disconnect the breathing tube and hang with both ends pointing to the floor until all water in the breathing tube has been cleared.

The device lid may not be closed correctly, the chamber seal may not be fitted to the water chamber correctly, or the outlet seal is missing.
Solution: Ensure the outlet seal and water chamber with the chamber seal are in the device. Refer to section 6.3 – Reassembly of the device for detailed instructions on reassembly of these parts.

The device restarts.

| Solution: It is possible that the device could restart due to Electromagnetic Interference (EMI). No actions are necessary as the device will restart and resume therapy. If restarts continue to occur, ensure there is sufficient space between the SleepStyle device and other electrical devices that may cause interference.
The device is noisy.| Air may be leaking out of the device or breathing tube.
Solution: Make sure the device lid has been closed properly, the breathing tube and mask are connected correctly, and there are no air leaks or condensation in the breathing tube.
If the noise is changing while you breathe, this is because the device adjusts the motor speed to maintain the correct pressure as you breathe in and out. This is normal behavior.
The base of the device is warm to the touch even though the device isn’t being used.| This is normal and should not cause concern. In stand-by mode, the device consumes approximately 5 W of power. This may cause the feeling of warmth.
There is a build-up of water on the heater-plate.| When therapy has stopped, the device will cool, which may cause condensation to form on the heater-plate.
Solution: To reduce condensation, please keep the device plugged in and switched on at the power supply after stopping therapy. Before each use, remove the water chamber and dry the chamber housing of the device with a cloth. If the water build-up becomes excessive, please contact your healthcare provider.
Problem| Solution
---|---
I don’t think my humidifier is working.| The humidity level may be incorrect.
Solution: Check if the humidity level is above 0. See section 3.6 – Comfort Settings for more information on changing the humidity setting.
The water chamber may be empty.
Solution: Check if there is water in the water chamber. See section 2.2 – Setting Up Your Device for instructions on filling your water chamber.
The ThermoSmart breathing tube is not connected to the device correctly.
Solution: Remove the ThermoSmart breathing tube from the device and re- connect. Make sure that the electrical connectors click together with the ThermoSmart connection. When connected correctly, the ThermoSmart icon    will appear on your home screen.
Solution: The humidity may be temporarily reduced due to Electromagnetic Interference (EMI). Stop and then restart therapy again using the Start / Stop button and full humidity will be enabled.
**** The ThermoSmart icon has a line through it  or there is a gap where this icon should appear.| The tube may not be connected correctly or there may be an error with the ThermoSmart breathing tube. You will still be treated and get humidity, but it may not be optimal.

Solution: Remove the ThermoSmart breathing tube from the device and re- connect. Make sure that the electrical connectors click together with the ThermoSmart connection. When connected correctly, the ThermoSmart icon   will appear on your home screen.

You may be using a standard breathing tube. Consult your healthcare provider for more information.
The InfoUSB icon has a line through it   or there is a gap where this icon should appear.| The InfoUSB may not be connected correctly or there may be an error with the InfoUSB. You will still be treated, but your therapy data may not be recorded to the InfoUSB. Solution: Remove the InfoUSB from the InfoUSB port and reinsert. When connected correctly, the InfoUSB icon will appear on your home screen.
**** The Bluetooth icon has a line through it  .| The Bluetooth setting is turned “Off” on your device or there may be an error with the Bluetooth setting. You will still be treated, but your therapy data may not be available on your SleepStyle app.
Solution: Turning the Bluetooth setting off and on again on your mobile device may resolve connectivity issues. Refer to section 4.2 – View your therapy data on the SleepStyle App or website for instructions on changing your Bluetooth setting.
**** The modem icon has a line through it  .| Modem is turned “Off” on your device or the modem has failed to connect. You will still be treated, but your therapy data may not be uploaded to your healthcare provider.
Solution: Turning modem off and on again on your SleepStyle device may resolve connectivity issues. Refer to section 5.1 – Modem for instructions on changing your modem setting.

Warnings
*If your problem persists please contact your healthcare provider.
9.2 ERROR MESSAGES ON SLEEPSTYLE SCREEN
If a fault is detected with your device or its accessories, an error message will appear on the display screen. Identify the error code in the ranges specified below and follow the appropriate corrective action. If the error persists or reoccurs, please consult your healthcare provider. Do not attempt to repair the device yourself.

may have shut down or may not be able to provide your prescribed pressure.
Solution: Turn the power off and on at the power supply to restart the device.
400–499| Humidity may have been disabled. Your device is still safe to use without humidity. You will still be treated at your prescribed pressure.
Solution: Turn the power off and on at the power supply to restart the device.

510 or 512

| There may be a problem with your ThermoSmart breathing tube. Your device is still safe to use. You will still be treated and get humidity, but it may not be optimal.
Solution: Try reconnecting your ThermoSmart breathing tube. When connected correctly, the ThermoSmart icon   will appear on the home screen. Alternatively, turn the power off and on at the power supply to restart the device.
500–599 (excluding 510 or 512)| The ThermoSmart breathing tube may have been disabled. Your device is still safe to use. You will still be treated and get humidity, but it may not be optimal.
Solution: Turn the power off and on at the power supply to restart the device.

SleepStyle, SensAwake, ThermoSmart, and F&P InfoUSB are trademarks of Fisher & Paykel Healthcare Ltd.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG Inc. and any use of such marks by Fisher & Paykel Healthcare is under license. Other trademarks and trade names are those of their respective owners. Android and Google Play are trademarks of Google Inc.
“Made for iPhone” means that an electronic accessory has been designed to connect specifically to iPhone, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPhone may aµect wireless performance. Apple, OS X, Mac and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries.
Windows is either a registered trademark or trademark of Microsoft Corporation in the United States and/or other countries.
For patent information, see www.fphcare.com/ip.

Manufacturer
Fisher & Paykel Healthcare Ltd,
15 Maurice Paykel Place, East Tamaki, Auckland 2013
PO Box 14 348 Panmure, Auckland 1741,
New Zealand
Tel: +64 9 574 0100
Fax: +64 9 574 0158
Email: [email protected]
Web: www.fphcare.com
Importer/ Distributor
Australia (Sponsor)
Fisher & Paykel Healthcare Pty Ltd,
19-31 King Street, Nunawading,
Melbourne, Victoria 3131.
Tel: +61 3 9871 4900
Fax: +61 3 9871 4998
UK
Fisher & Paykel Healthcare Ltd,
Unit 16, Cordwallis Park,
Clivemont Road, Maidenhead,
Berkshire SL6 7BU, UK
Tel: 0800 132 189
Fax: +44 1628 626 146
USA/Canada
Tel: 1800 446 3908
or +1 949 453 4000
Fax: +1 949 453 4001
REF 616590 REV B 2021–07 © 2021 Fisher & Paykel Healthcare Limited

References

• F&P SleepStyle™ - Fisher and Paykel Healthcare Limited
• Home | Fisher & Paykel Healthcare
• Home | Fisher & Paykel Healthcare
• About Us | Fisher & Paykel Healthcare

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