FCC ID: 2ACHL-AIR114G Continuous Positive Airway Pressure (CPAP) Device

 

U

s

e

r

g

u

i

d

e

User guide

English

Setting Up

Tub

Tubing

Device

Power Cord

Power Supply

Mask



ENGLISH

Contents

Welcome ............................................................................................................................................... 1

Indications for use .................................................................................................................. 1

Contraindications .................................................................................................................... 1

Adverse effects ...................................................................................................................... 1

ResMed Product Software License Terms............................................................................. 2

At a glance ............................................................................................................................................ 3

About your device ................................................................................................................... 4

Setting up your device ......................................................................................................................... 5

Navigating the touch screen ................................................................................................................ 7

Additional features .................................................................................................................. 8

Connecting your AirSense 11 device and smart device ......................................................... 9

Starting/Stopping therapy ................................................................................................................... 9

About the heated tubing .................................................................................................................... 10

Therapy data ....................................................................................................................................... 11

Cleaning and caring for the device .................................................................................................... 12

Disassembling ...................................................................................................................... 13

Cleaning ................................................................................................................................ 13

Checking ............................................................................................................................... 14

Replacing the air filter ........................................................................................................... 15

Reassembling ....................................................................................................................... 15

Traveling ............................................................................................................................................. 15

Traveling by plane ................................................................................................................. 15

Troubleshooting ................................................................................................................................. 16

General warnings ............................................................................................................................... 17

Technical specifications ..................................................................................................................... 18

Guidance and manufacturer’s declaration electromagnetic emissions and immunity ................. 23

Symbols .............................................................................................................................................. 24

Servicing ............................................................................................................................................. 25

Limited warranty ................................................................................................................................. 25

Further information ............................................................................................................................ 26

i



Welcome

The AirSense™ 11 AutoSet™ (including AutoSet for Her) device is ResMed's premium auto-adjusting

pressure device. The AirSense 11 Elite and the AirSense 11 CPAP are ResMed's Continuous Positive

Airway Pressure (CPAP) devices.

Read this entire guide before using the device.

WARNING

CAUTION

In the US, Federal law restricts this device to sale by or on the order of a physician.

Indications for use

AirSense 11 AutoSet (including AutoSet for Her)

The AirSense 11 self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in

patients weighing more than 66 lb (30 kg), including female patients with mild to moderate OSA in AutoSet

for Her mode. The AirSense 11 self-adjusting system is intended for home and hospital use.

AirSense 11 CPAP (including Elite)

The AirSense 11 CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients

weighing more than 66 lb (30 kg). The AirSense 11 CPAP system is intended for home and hospital use.

Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing

conditions:

• severe bullous lung disease

• pneumothorax or pneumomediastinum

• pathologically low blood pressure, particularly if associated with intravascular volume depletion

• dehydration

• cerebrospinal fluid leak, recent cranial surgery, or trauma.

Adverse effects

You should report unusual chest pain, severe headache, or increased breathlessness to your prescribing

physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment.

The following side effects may arise during the course of therapy with the device:

• drying of the nose, mouth, or throat

• nosebleed

• bloating

• ear or sinus discomfort

• eye irritation

• skin rashes.

English

1



ResMed Product Software License Terms

Ownership: This ResMed product includes ResMed proprietary software owned or licensed to ResMed

(the "Product Software"). The Product Software is licensed to the owner and user of the ResMed product

as such license is described below. Neither the Product Software nor any intellectual property rights in the

Product Software are sold or assigned by ResMed, and ResMed retains all interest to software,

modifications, improvements, upgrades, derivative works and all other intellectual property rights in

connection with the Product Software.

License: Subject to the terms and conditions below, ResMed grants to the owner and/or user of the

ResMed product a non-exclusive, non-transferable (save as further provided for below), non-sublicensable,

personal, limited license to use the Product Software solely in connection with the use of the ResMed

product. All other rights are reserved by ResMed. The owner and user of the ResMed product will be

deemed to have transferred and assigned this license to any person that acquires the owner’s or the

user’s rights in the ResMed product that includes the Product Software.

License Restrictions: No person or entity is licensed or authorized to (a) reproduce, distribute, create

derivative works, modify, display, perform, decompile or attempt to discover the source code for the

Product Software, (b) remove or attempt to remove the Product Software from the ResMed product, or (c)

reverse engineer or disassemble the ResMed product or the Product Software. Any person or entity that

does any of the foregoing is in breach of the license to use the Product Software and is infringing

ResMed’s intellectual property rights in the Product Software. For avoidance of doubt, the foregoing

restrictions are not intended to limit any licensee’s rights to software code incorporated into or distributed

with the Product Software and licensed under the terms of any open source, free or community software

license (collectively, "Open Source Software"). NOTWITHSTANDING THE TERMS OF THIS LICENSE, ANY

SUCH OPEN SOURCE SOFTWARE IS PROVIDED ON AN "AS-IS" BASIS AT THE SOLE RISK OF THE

OWNER AND USER OF THE RESMED PRODUCT, AND RESMED MAKES NO EXPRESS OR IMPLIED

WARRANTIES OF ANY KIND WITH RESPECT TO SUCH OPEN SOURCE SOFTWARE.

Breach of License Terms: If the owner or user of the ResMed product breaches the license or the

license restrictions set forth above (a "Breach"), then ResMed will be entitled to all available remedies at

law and in equity. In addition, in the event of a Breach, ResMed may, to the extent not prohibited by

applicable law (a) suspend or terminate any or all services being provided by ResMed to the owner or user

of the ResMed product, (b) disable the ability of the Product Software to transmit data to the ResMed

cloud, (c) disable the Product Software, or (d) terminate this License. Furthermore, in the event of a

Breach, the person that commits the Breach agrees to indemnify and hold harmless ResMed, and its

affiliates and each of their respective directors, officers, employees and agents from and against all claims,

suits, actions, proceedings, investigations, losses, liabilities, damages, settlement amounts, costs and

expenses (including without limitation reasonable attorneys’ and expert witness’ fees and other costs of

defense) arising out of or related to the Breach.

Download of Product Software Updates: The owner and user of the ResMed product agree that

ResMed and the ResMed product may from time to time download updates and upgrades to the Product

Software on the ResMed product, in each case without notice to the owner or user, and without having to

obtain the consent of the owner or user. Such downloads may be done automatically, and by any means

selected by ResMed, including but not limited to using Bluetooth® wireless technology, WiFi and/or

cellular networks and combinations of various wireless technologies and services for over-the-air (OTA)

updates, as well as wired, memory card and other data transfer technologies. Such updates to the Product

Software might include, without limitation, bug fixes, error corrections, security patches, and new versions

and releases of the Product Software that includes new features and functions.

2



At a glance

WARNING

Use only recommended ResMed masks and accessories or other vented masks as recommended by

the prescribing doctor with this device. Using these components allows normal breathing and

prevents potential asphyxiation.

The AirSense 11 system includes the following:

• Device

• HumidAir™ 11 Standard tub

• ClimateLineAir™ 11 heated tubing or SlimLine™ tubing

• 65W AC adaptor

• Travel bag

• SD card (not available in all devices).

Contact your care provider for a range of accessories available for use with the device including:

• Air tubing (ClimateLineAir 11 and SlimLine)

• HumidAir 11 Standard tub

• HumidAir 11 Cleanable tub (can be disinfected)

• End cap which allows use without the humidifier

• Air11™ Filter - standard

• Air11 Filter - hypoallergenic

• SD card

Notes:

• The AirSense 11 device is compatible with ResMed masks. For a full list, see the Mask/Device

compatibility list on ResMed.com/downloads/devices.

• The HumidAir 11 Standard tub and HumidAir 11 Cleanable tub are the only water tubs used with the

AirSense 11 device.

• The ClimateLineAir 11 is the only heated tubing that is compatible with the AirSense 11 device.

English

3



About your device

Press to start/stop therapy.

The LED indicator is green during standby mode, and white during

therapy, Test Drive, and Mask Fit functions.

Navigates between functions and displays information on the

operating status of the device.

Water tub that provides heated humidification.

Contains information relevant to the device.

Connects the air tubing

Connects the power cord

Removable cover that protects the SD card slot.

The LED indicator is blue when data is written to the SD card.

Description

Purpose

1

Start Therapy/ Standby button

Display touch screen

HumidAir 11 tub

Device label

Outlet connector

Power inlet

SD card cover

Air inlet filter cover

Contains the air filter

9

SlimLine tubing

Non-heated air tubing

10 ClimateLineAir 11 tubing

Heated air tubing

Notes:

If the Start therapy/ Standby button has a flashing white light, a system error has occurred. Refer to the

Troubleshooting section for more information.

• Use this device only as directed by your physician or healthcare provider.

2

3

4

5

6

7

8

•

4



Setting up your device

WARNING

CAUTION

Do not use any additives in the humidifier tub (eg, scented oils or perfumes). These may reduce

humidification output and/or cause deterioration of the tub materials.

Use only ResMed parts (eg air inlet filter, power supplies), masks and accessories with the machine.

Non ResMed parts may reduce the effectiveness of the treatment, may result in excess carbon

dioxide rebreathing and/or damage the machine. For compatibility information, refer to

ResMed.com for more information.

When using the humidifier tub:

• Always place the device on a level surface, lower than your head, to prevent the mask and air

tubing from filling with water.

• Do not overfill the humidifier tub as water may enter the device and air tubing.

• Do not fill the humidifier tub with hot water as this could lead to excessive air temperature at the

mask. Ensure the water is cooled to room temperature before filling the humidifier tub.

• Do not place the device on its side while the humidifier is attached as water might get into the

device and reduce motor life.

When setting up the AirSense system:

• Do not place the power supply where it can be bumped, stepped on, or where someone is likely

• Do not block the air tubing and/or air inlet of the device while in operation as this could lead to

to trip over the power cord.

overheating of the device.

• Keep the area around the device dry, clean and clear of anything (eg, clothes or bedding) that

could block the air inlet or cover the power supply unit.

• Ensure the system is correctly setup. Incorrect system setup may result in incorrect mask

pressure reading.

When using a mask:

• Use only vented masks recommended by ResMed or by the prescribing doctor with this device.

• Fitting the mask without the device blowing air can result in rebreathing of exhaled air.

• Make sure that the mask vent holes are kept clear and unblocked to maintain the flow of fresh air

into the mask.

English

5



To set up the device:

1. Place the device on a stable level surface.

2. Connect the power cord into the power inlet at the rear of the device. Connect one end of the power

cord into the AC adaptor and the other end into the power outlet.

3. Connect the air tubing firmly to the outlet connector at the rear of the device.

4. Open the humidifier tub and fill it with distilled water under room temperature up to the maximum

water level mark. The humidifier tub must be removed from the device before adding water. The

humidifier tub has a maximum capacity of 380 mL.

5. Close the humidifier tub and insert it into the side of the device.

6. Connect the free end of the air tubing firmly onto the assembled mask.

See the mask user guide for detailed information.

Recommended masks for use with this device are listed on Resmed.com

Notes:

• Do not insert any USB cable into the AirSense 11 device or attempt to plug the AC adaptor into a USB

device. This may cause damage to the AirSense 11 device or USB device.

• The electrical connector end of the heated air tubing is only compatible with the air outlet at the device

end and should not be fitted to the mask.

• Do not use electrically conductive or anti-static air tubing.

6



Navigating the touch screen

The AirSense 11 device operates via a display touch screen, which allows you to access, view and change

therapy and device settings. You can also track your sleep health progress.

The status bar at the top of the screen may display icons at different times and may include:

Icon

Description

Home Screen

Humidifier fault

Purpose

Return to the Home screen at any time.

Detects fault in the humidifier. Therapy will run without

heating.

Humidifier warming

Water in the humidifier tub is pre-heating.

Humidifier cooling

Water in the humidifier tub is cooling.

Bluetooth® connected

Device is successfully connected via Bluetooth.

Cellular signal strength

Indicates the strength of cellular connectivity

No cellular connection

Cellular coverage is not available

Airplane mode

Device is in airplane mode

1. From the Welcome screen, tap USER

2. From the Home screen, you can access the following menus:

• MY OPTIONS: View and adjust therapy settings (eg, Adjust Ramp time)

• MY SLEEP VIEW: Track sleep health (check the number of hours used last night or mask status)

• MORE: Access additional features such as Run Mask Fit or switch to Airplane mode.

English

7



Using the touch screen:

8

There are two actions to navigate through the touch screen:

Flick: Flick up or down the screen to view menu options. A flick action will move the menu one full screen.

Tap: Select a parameter setting to update. For other parameters (eg Pressure Relief, Airplane mode), tap

the parameter to turn it on

or tap to turn it off

.

Personalizing your settings

The device has been set up for your needs by your care provider, but you may want to make adjustments

to make your therapy more comfortable.

1. Tap MY OPTIONS from the Home screen.

2. Tap the parameter you wish to change.

3. Tap the preferred setting.

Tap OK to confirm the change or CANCEL to go back to the previous screen.

Additional features

There are some other features on your device which you can personalize.

Menu

Function

Description

MY

OPTIONS

Ramp Time

Period during which the pressure increases from a low start pressure to the

prescribed treatment pressure.

Ramp Time can be set to Off, 5 to 45 minutes (in 5-minute increments), or

Auto.

Pressure

Relief*

When EPR is enabled, you may find it easier to breathe out. This setting can

help you get used to therapy.

SmartStart* When SmartStart is enabled, therapy starts automatically when you breathe

into your mask.

SmartStop* When SmartStop is enabled, therapy stops automatically after a few

seconds when you remove your mask.

MORE

Mask Fit

This function helps you assess and identify possible air leaks around your

mask.

*Features enabled by your care provider.

Note: Not all functions are available in all regions. Functions vary based on therapy mode.



Connecting your AirSense 11 device and smart device

RMDpulse is a smartphone app that guides you through the setup process. This includes device setup

videos, mask fitting videos, trying therapy using the Test Drive feature, and tracking your sleep health

progress. The app is not required to operate the AirSense 11 device.

Before pairing the AirSense 11 device to a smartphone, ensure the app's latest version is installed on the

smartphone. If not, download the app from the App Store® or on Google® Play. Pair the AirSense 11 device

to your phone. To set up the app, go to the MORE menu.

1. Ensure your AirSense 11 device is set up correctly and plugged into a power source.

2. Launch the RMDpulse app. Tap Continue.

3. Follow the prompts on the RMDpulse app to complete the BT connection.

AirSense 11 is now connected to the app. The Bluetooth connection symbol appears on the status bar

to confirm the connection between the AirSense 11 device and the smartphone.

4. Tap Done.

Starting/Stopping therapy

WARNING

To start therapy:

The machine is not intended to be operated by persons (including children) with reduced physical,

sensory or mental capabilities without adequate supervision by a person responsible for the

patient’s safety.

1. Fit your mask

2. Press the Start therapy/Standby button or breathe normally if

SmartStart is enabled.

Therapy will begin and the Treatment screen is displayed. A dynamic

pulse wave will appear during therapy.

Notes:

• The screen will fade and then go black automatically after a short period of time. Tap the screen to turn

it back on.

•

If power is interrupted during therapy, the device will automatically restart therapy when power is

restored.

• The device has a light sensor that adjusts the screen brightness based on the light in the room.

To stop therapy:

1. Remove your mask.

2. Press the Start/Standby button or wait until the device stops if SmartStop is enabled.

English

9



About the heated tubing

The ClimateLineAir 11 is a heated breathing tube that delivers air to a compatible mask. When used with

the device humidifier tub, ClimateLineAir 11 heated air tubing allows you to use the Climate Control

feature.

Note: Not all types of air tubing are available in all regions.

Climate Control

Climate Control is designed to make therapy more comfortable by enabling constant temperature and

maintaining humidity.

This feature:

• delivers comfortable humidity level and temperature during therapy

• maintains the set temperature and relative humidity during sleep to prevent dryness in the nose and

mouth

• can be set to either Auto or Manual

•

is only available when both the ClimateLineAir 11 and HumidAir tub are attached.

Climate Control - Auto setting

Auto is the recommended and default setting. It is designed to make therapy as easy as possible so there

is no need to change the temperature or humidity settings.

• Sets the tube temperature to Auto (80ºF/27ºC). If the air in the mask is too warm or too cold, you can

adjust the tube temperature to anywhere from 60 to 86ºF (16 to 30ºC) or turn it off completely

• Adjusts the humidifier output to maintain a constant, comfortable humidity level of 85% relative

humidity

• Protects against rainout (water droplets in the heated air tubing and mask).

Climate Control - Manual setting

Manual is designed to offer more flexibility and control over settings and offers the following:

• Temperature and humidity can be adjusted to find the most comfortable setting

• Temperature and humidity level can be set independently

• Rainout protection is not guaranteed. If rainout does occur, first try increasing the tube temperature

•

Note: If Climate Control is set to Manual, the Auto Tube Temperature setting is not available.

If the air temperature becomes too warm and rainout continues, try decreasing the humidity.

Humidity Level

The humidifier moistens the air and is designed to make therapy more comfortable.

•

•

• You can set the Humidity Level to Off or between 1 and 8, where 1 is the lowest humidity setting, and

If you are getting any moisture in your mask, turn down the humidity.

If you are getting a dry nose or mouth, turn up the humidity

8 is the highest humidity setting.

To update the setting for Tube Temperature, Climate Control, or Humidity Level, tap MY OPTIONS

from the Home screen, go down the list of options, and select the setting.

Note: Tube Temp Auto setting is only relevant when using the Climate Control Auto setting. If Climate

Control is set to Manual, Auto set temperature is not a valid selection.

10



Tube Temperature

Climate Control

Humidity Level

1. Tap Humidity Level.

2. Tap the preferred setting.

3. Tap OK to save the change.

1. Tap Climate Control.

2. Tap Manual.

3. Tap OK to save the change.

1. Tap Tube Temp.

2. Tap the preferred setting.

3. Tap OK to save the change.

Note: The temperature and humidity settings are not measured values.

Therapy data

The AirSense 11 device records your therapy data for viewing and adjusting by your care provider if

required. The data is transferred to your care provider in the following methods:

Wireless

The device is equipped with cellular communication that allows your sleep therapy data to be wirelessly

transmitted to your care provider. It also allows for your therapy settings to be updated.

Transfer of data will occur after therapy has stopped. Leave your device connected to the power outlet at

all times and make sure it is not in Airplane Mode. Data will only be transferred if a wireless connection is

available.

Please be aware that within the wireless network, the availability and quality of the network may be

affected by terrain, buildings, and the weather. Wireless communication depends on network availability.

Coverage is not available everywhere and varies by service.

Notes:

• Therapy data might not be transmitted if you use it outside of the country or region of purchase.

• Devices with cellular communication might not be available in all regions.

SD card

Your sleep therapy data may be transferred to your care provider via SD Card (if provided). Your care

provider may ask you to send the SD card by mail or to bring it in. Only remove the SD card when

instructed by your care provider.

To use the SD card to record your sleep data, remove the SD card cover.

Do not remove the SD card from the device when the SD light is flashing, because data is being written to

the card.

Note: The SD card should not be used for any other purpose as it may corrupt therapy data stored on the

card.

English

11



To remove the SD card cover and insert SD card:

1. Push the SD card cover.

2. Remove the SD card cover and keep the SD card cover in a safe place.

3. Insert the SD card.

4. Push in the SD card until it clicks in place.

To remove the SD card:

1. Push in the SD card to release it.

2. Place the SD card in the protective folder and follow your care provider’s instructions.

For more information on the SD card, refer to the SD card protective folder provided with your device.

Cleaning and caring for the device

WARNING

• Beware of electrocution:

• Do not immerse the device, AC Adaptor or power cord in water.

• Do not connect to power while the device is wet. Make sure that all parts are dry before

plugging it in.

back in.

operation.

•

If liquids are spilled into or onto the device, unplug the device and let the parts dry.

• Always unplug the device before cleaning and ensure that all parts are dry before plugging it

• Do not perform any maintenance tasks (eg, cleaning, changing the air filter) while the device is in

• Clean the device and its components according to the schedules shown in this guide, to maintain

the quality of the device and to prevent the growth of germs that can adversely affect your

health.

• Regularly inspect power cords, cables, and power supply for damage or signs of wear.

Discontinue use and replace if damaged.

• Do not open or modify the device. There are no user serviceable parts inside. Repairs and

servicing should only be performed by an authorized ResMed service agent.

12



CAUTION

• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial

soaps or scented oils to clean the device, the humidifier tub or air tubing. These solutions may

cause damage or affect the humidifier performance and reduce the life of the products. Exposure

to smoke, including cigarette, cigar or pipe smoke, as well as ozone or other gases, may damage

the device. Damage caused by any of the foregoing, will not be covered by ResMed's limited

warranty.

• Leave the humidifier tub to cool for ten minutes before handling to allow the water to cool and to

make sure that the humidifier tub is not too hot to touch.

The following sections will help you with:

• Disassembling

• Cleaning

• Checking

• Reassembling.

Disassembling

1. Hold the humidifier tub at the top and bottom, press it gently and pull it away from the device.

Note: Take care when handling the humidifier tub as the humidifier tub may be hot. Allow 10 minutes

for the heater plate and any excess water to cool.

2. Open the humidifier tub and discard any remaining water.

3. Pinch the cuff of the air tubing, and gently pull it away from the device.

4. Hold both the cuff of the air tubing and the swivel of the mask, then gently pull apart.

5. Locate the outlet connector on the inside of the device and release it by pressing the clip firmly.

6. Remove the outlet connector by pulling it out through the outlet connector socket at the rear of the

device.

Cleaning

The following instructions are for home cleaning. Instructions for reprocessing devices intended for multi-

patient re-use can be found in the clinical guide.

You should clean the device, humidifier tub, air tubing, and outlet connector as described.

English

13



Daily:

1. Empty the humidifier tub and wipe it thoroughly with a clean disposable cloth. Allow it to dry out of

direct sunlight.

2. Refill the humidifier tub with distilled water.

Weekly:

1. Wash the humidifier tub, air tubing, and outlet connector in warm water using a household dishwashing

liquid. They should not be washed in temperatures higher than 149°F (65°C).

2. Rinse each component thoroughly in water.

3. Allow to dry out of direct sunlight or heat.

4. Wipe the exterior of the device with a dry cloth.

Notes:

• The humidifier tub may be washed in a dishwasher on the delicate cycle (top shelf only).

• Do not wash the air tubing in a dishwasher or washing machine.

• The air filter is not washable or reusable.

For cleaning your mask, refer to the mask user guide for detailed instructions.

Checking

WARNING

• Discontinue use and contact your care provider or ResMed Service Center if any of the following

occur:

• device does not perform as usual

• device is making unusual sounds

• device is damaged

If any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.),

the component should be discarded and replaced.

If used, regularly check the bacterial/viral filter for signs of moisture or other contaminants,

particularly during nebulization or humidification. Failure to do so could result in increased

breathing resistance.

Regularly check the humidifier tub, air tubing, and air filter for any damage.

1. Check the humidifier tub:

• Replace it if it is leaking or has become cracked, cloudy, or pitted.

• Replace it if the seal is cracked or torn.

• Remove any white powder deposits using a solution of one-part household vinegar to 10 parts

water. Rinse with clean water.

2. Check the air tubing and replace it if there are any holes, tears or cracks.

3. Check the air filter and replace it at least every six months. Replace it more often if there are any holes

or blockages by dirt or dust.

•

•

14



Replacing the air filter

1. Open the air filter cover and remove the old air filter. The air filter is not washable or reusable.

2. Place a new air filter onto the air filter cover and then close the cover. Make sure the air filter and air

filter cover is fitted at all times to prevent water and dust from entering the device.

Reassembling

When the humidifier tub and air tubing are dry, you can reassemble the parts.

To reassemble the AirSense 11 system:

1. Hold the outlet connector with the seal pointing to the left and the clip pointing forward.

2. Make sure the outlet connector is correctly aligned and insert the outlet connector into the socket.

3. Check the outlet connector is inserted correctly.

4. Connect the air tubing firmly to the air outlet located on the rear of the device..

5. Open the humidifier tub and fill it with distilled water under room temperature up to the maximum

water level mark.

6. Close the humidifier tub and insert it into the side of the device.

7. Connect the free end of the air tubing firmly onto the assembled mask.

Traveling

You can take your device with you wherever you go. Just keep the following in mind:

• Use the travel bag provided to prevent damage to the device.

• Empty the humidifier tub and pack it separately in the travel bag.

• Make sure you have the appropriate power cord for the region you are traveling to. For information on

purchasing, contact your care provider.

Traveling by plane

WARNING

due to the risk of:

• water spilling into the device

•

the inhalation of water during turbulence.

• Do not use the device with water in the humidifier tub while in transit (eg. on a plane or vehicle)

• Make sure that the humidifier tub is empty before transporting the device.

Your AirSense device may be taken on board as carry-on luggage. Medical devices do not count toward

your carry-on luggage limit.

You can use your AirSense device on a plane as it meets the Federal Aviation Administration (FAA)

requirements. Air travel compliance letters can be downloaded and printed from www.resmed.com.

When using the device on a plane:

• Make sure the humidifier tub is empty and inserted into your device. The device will not work without

the humidifier tub inserted.

• Make sure the device is switched to airplane mode when required by airline staff.

English

15



To turn on Airplane mode:

1. From the Home screen, tap MORE.

2. Flick down the menu to locate Airplane Mode.

3. Tap Airplane mode to switch it on.

Troubleshooting

If you have any problems, have a look at the following troubleshooting topics. If you are not able to fix the

problem, contact your care provider or ResMed. Do not try to open the device.

General Issues

Problem/possible cause

Air is leaking from around my mask

Mask may be fitted incorrectly.

Solution

Make sure your mask is fitted correctly. See your mask user guide for

fitting instructions, run the mask fit function or refer to the Mask Fit video

in the app.

I am getting a dry or blocked nose

Humidity level may be set too low.

Increase the Humidity Level.

I am getting droplets of water on my nose, in the mask and air tubing

Humidity level may be set too high.

Decrease the Humidity Level.

Tube temperature may be too low.

Increase the Tube Temperature.

My mouth is very dry and uncomfortable

Air may be escaping through your mouth.

You may need a chin strap to keep your mouth closed or a full face mask.

Power may not be connected.

Connect the AC adaptor and make sure the plug is fully inserted.

My screen is black

My humidifier tub is leaking

Humidifier tub may not be assembled correctly.

Check for damage and reassemble the humidifier tub correctly.

Humidifier tub may be damaged or cracked.

Contact your care provider for a replacement.

My therapy data has not been sent to my care provider

Wireless coverage may be poor/The no wireless

is displayed on the top right of

connection icon

the screen.

Make sure that the device is placed where there is coverage (ie, on your

bedside table, not in a drawer or on the floor).

The wireless signal strength icon

bars are displayed, and poor coverage when fewer bars are displayed.

indicates good coverage when all

Device may be in Airplane Mode.

Turn off Airplane Mode.

Data transfer is not enabled for your device.

Talk to your care provider about your settings.

SmartStart is enabled, but the device does not automatically start when I breathe into the mask

Breath is not deep enough to trigger SmartStart

To start therapy, take a deep breath in and out through the mask, before

breathing normally.

Press the Start/Stop button located on top of the device.

Air tubing may not be connected properly. Connect firmly at both ends.

There is excessive leak

Adjust the mask and headgear

16



Problem/possible cause

Solution

SmartStop is enabled, but does not automatically stop when I remove the mask.

Incompatible mask being used

Only use equipment recommended by ResMed.

Contact ResMed or see ResMed.com for more information.

If you are using a nasal pillows mask with set pressure less than 7 cm

H2O (7 hPa). SmartStop will not work and should be disabled.

If you are using a conduit mask, SmartStop will not work and should be

disabled.

Solution

Allow to cool before re-use. Disconnect the AC adaptor and then

reconnect it to restart the device.

Check the air filter and replace it if there are any blockages.

Disconnect the AC adaptor and then reconnect it to restart the device.

Empty the water from the air tubing. Disconnect the AC adaptor and

then reconnect it to start the device.

Device Messages

Problem/possible cause

System fault, refer to user guide, Error 4

Device may have been left in a hot environment.

Air filter may be blocked.

There may be water in the air tubing.

General warnings

WARNING

All other error messages, for example, System fault, refer to user guide Error X

An unrecoverable error has occurred on the device.

Contact your care provider. Do not open the device.

• Any change or modification to the product is not expressly approved by ResMed and could void

the user's authority to operate the device.

• Supplemental oxygen must not be used while smoking or in the presence of an open flame.

• When using the device with an oxygen supply, check the following:

• Starting therapy – ensure the device is on and blowing air before the oxygen supply is turned

on.

• Stopping therapy – ensure the oxygen supply is turned off first, then the device.

This will ensure oxygen does not accumulate within the device and create a risk of fire.

• The device has not been tested or certified for use in the vicinity of X-ray, CT or MRI equipment.

Do not bring the device within 13 ft (4 m) of X-ray or CT equipment. Never bring the device into

an MR (Magnetic Resonance) environment.

• 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 accessories other than those specified for the device is not recommended. These may

increase radio frequency energy or be influenced by the interference and result in improper

operation.

For any serious incidents that occur in relation to this device, these should be reported to ResMed and the

competent authority in your country.

English

17



Technical specifications

65W AC adaptor

AC input range:

DC output:

Typical power consumption:

Peak power consumption:

Class of Equipment:

Environmental conditions

Operating temperature:

100-240v, 50-60Hz, 2.0A

115V, 400Hz, 1.5A (for aircraft use)

24 VDC ± 1 VDC, 2.71A

9.0W

71.9W

Class II

Operating humidity:

Operating altitude:

Storage pressure/ Storage Altitude

Storage and transport temperature:

Storage and transport humidity:

Flow measurement tolerance

± 6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow

Pressure measurement tolerance

± 0.5 cm H2O ±4% of measured reading

+41°F to +95°F (+5°C to +35°C)

Note: The airflow for breathing produced by this therapy device can be

higher than the room temperature. Under extreme ambient temperature

conditions (104°F/40°C) the device remains safe.

10 to 95% relative humidity, non-condensing

Sea level to 9,870' (3,010 m); air pressure range 700 hPa to 1060 hPa;

700 to 1060 hPa

-13°F to +158°F (-25°C to +70°C)

5 to 95% relative humidity, non-condensing

Flow (maximum) at set pressures

The following are measured accordingly to ISO 80601-2-70 201.12.1.103

Pressure

cm H2O (hPa)

AirSense 11, humidifier tub

and Standard air tubing

L/min

AirSense11, humidifier tub

and SlimLine

L/min

AirSense 11, humidifier tub

and ClimateLineAir 11

L/min

150

147

143

140

136

145

142

138

135

131

144

141

138

134

129

Notes:

• Refer to the relevant measurement uncertainty from the table below

• Values are after gas standard conversion to STPD (ie, correction factor of 0.9962) and additional 5% guard banding to

buffer the claimed values and rounded down.

Mode pressure range

CPAP

CPAP with EPR mode:

AutoSet, AutoSet for Her mode:

AutoSet, AutoSet for Her mode with EPR:

4-20 cm H2O (4-20 hPa) (measured at the mask)

4-20 cm H2O (4-20 hPa) CPAP with EPR settings: EPR off, Level 1 = 1.0 cm H2O,

Level 2 = 2.0 cm H2O, Level 3 = 3.0 cm H2O

EPR reduces the pressure during expiration by the amount dependent on the

level set above, but the pressure delivered will not drop below 4.0 cm H2O.

4-20 cm H2O (4-20 hPa)

4-20 cm H2O (4-20 hPa) APAP with EPR settings: EPR off, Level 1 = 1.0 cm H2O

Level 2 = 2.0 cm H2O,*Level 3 = 3.0 cm H2O

EPR reduces the pressure during expiration by the amount dependent on the

level set above, but the pressure delivered will not drop below 4.0 cm H2O.

4

8

12

16

20

18



Sound

Pressure level measured according to ISO 80601-2-70:2015 and ISO 80601-2-79:2018:

Device with SlimLine and humidifier tub (tub half filled) : 27 dBA with uncertainty of 2 dBA

Power level measured according to ISO 80601-2-70:2015 and ISO 80601-2-79:2018:

Device with SlimLine and humidifier tub (tub half filled): 35 dBA with uncertainty of 2 dBA

Physical - device and humidifier tub

Dimensions (H x W x D):

Air outlet:

Wight (device and standard humidifier tub):

Weight (device and cleanable humidifier tub):

Housing construction:

Hot plate - material:

Water capacity:

Standard humidifier tub - material:

Cleanable humidifier tub - material:

Air filter

Standard:

Hypoallergenic:

5.45" x 10.21" x 3.72"

(138.5 mm x 259.4 mm x 94.5 mm)

The 22 mm conical outlet connector complies with EN ISO 5356-1:2015

40 oz (1130 g)

40 oz (1130 g)

Flame retardant engineering thermoplastic

Stainless steel

380 mL

Injection molded plastic, stainless steel and silicone seal

Injection molded plastic, stainless steel and silicone seal

Material: Polyester non woven fiber

Average arrestance: >75%, when tested to EN779.

Material: Blended synthetic fibers in a polypropylene carrier

Efficiency: >80% (av) when tested to EN13274-7.

Note: The use of a ResMed approved hypoallergenic filter will result in a

small reduction in the accuracy of the delivered pressure at high leaks.

Design life

Device, power supply unit:

Cleanable humidifier tub:

Standard humidifier tub

Air tubing:

5 years

2.5 years

6 months

6 months

Electromagnetic compatibility

The AirSense 11 complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC 60601-1-2:2014,

for residential, commercial and light industry environments.

Portable and mobile RF communications equipment should be used no closer to any part of the machine, including cables, than the

recommended 3.94" (10 cm) separation distance.

The AirSense11 has been designed to meet EMC standards. However, should you suspect that the device performance (eg.

pressure or flow) is affected by other equipment, move the device away from the possible cause of interference.

Information regarding the electromagnetic emissions and immunity of this ResMed device can be found in

ResMed.com/downloads/devices.

IEC 60601-1 (Edition 3.1) classification

Class II (double insulation), Type BF, Ingress protection IP22.

Aircraft use

ResMed confirms that the machine meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21,

category M; RTCA-DO-160, section 20, category T) for all phases of air travel.

Maximum single fault steady state pressure

Device will shut down in the presence of a single fault if the steady state pressure exceeds:

40 cm H2O (40 hPa) for more than 1 second.

English

19



Pneumatic flow path

1. Flow sensor

2. Blower

3. Pressure sensor

4. Mask

5. Air tubing

6. Humidifier

7. Device

8. Inlet filter

Displayed values - Pressure at Mask

Displayed mask pressure

Range

4-20 cm H2O

Pressure accuracy

Accuracy

±0.5 cm H2O ±4% of measured

reading

Display resolution

0.1 cm H2O

Maximum static pressure variation at 10 cm H2O (10 hPa) according to ISO 80601-2-70:2015

Device with humidifier tub and air tubing:

±0.5 cm H2O

Note: Refer to the relevant measurement uncertainty from the table below.

Stability of dynamic airway pressure accuracy (short term accuracy) according to ISO 80601-2-70:2015

Device with humidifier tub

and air tubing

SlimLine

Standard

ClimateLineAir 11

10 BPM

0.5 cm H2O

0.5 cm H2O

0.5 cm H2O

15 BPM

0.7 cm H2O

0.7 cm H2O

0.7 cm H2O

20 BPM

1.0 cm H2O

0.8 cm H2O

1.0 cm H2O

Measurement system uncertainties

In accordance with ISO 80601-2-70:2015 the measurement uncertainty of the manufacturer's test equipment is:

For measures of flow

For measures of static pressure

For measures of dynamic pressure

Note: ISO 80601-2-70:2015 stated accuracies and test results provided in this manual for these items already include the

relevant measurement uncertainty from the table above.

± 3.9 L/min

± 0.15 cm H2O (hPa)

± 0.04 cm H2O (hPa)

In accordance with ISO 80601-2-74:2017 the measurement uncertainty of the manufacturer's test equipment is:

For measures of humidification output

± 0.5 mg/L BTPS

Bluetooth

Technology used:

Connection types:

Frequency:

Max RF power output:

Operation range:

Bluetooth Low Energy (BLE)

GATT

2400 to 2483.5 MHz

+4 dBm

10 m (Class 2)

20



Wireless module

Technology used

2G

3G

4G LTE Cat 1

Frequencies (MHz)

900/ 1800 *

850/ 900/ 1700/ 1900/ 2100*

700/ 850/ 1700/ 1900*

Max RF power output (dBm)

33.0

23.5

23.0

*(bands may not be available in all regions)

FCC ID: 2ACHL-AIR114G

IC: 9103A-AIR114G

The AirSense 11 device complies with FCC Rules and Industry Canada 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.

The AirSense 11 device should be installed and operated with minimum distance of 0.59" (15 mm) between the equipment and the

user's body.

Additional information regarding the FCC Rules and IC compliance for this device can be found on ResMed.com/downloads/devices

In Canada, the device has been designed to comply with safety standards to radio waves (SAR) in accordance to RSS-102.

154ºF (68ºC)

165ºF (74ºC)

≤ 106ºF (41ºC)

Distilled water (Americas only)

Temperature

Maximum heater plate temperature:

Temperature Cut-out (heater):

Maximum gas temperature: (at mask)1

Recommended water type to use in the humidifier

tub (Standard tub)

time between each refill of the humidifier tub

> 8 hours ± 0.5 hours*

1 The air flow for breathing produced by this therapy device can be higher than the temperature of the room. Under extreme

ambient temperature conditions (104ºF/40ºC) the device remains safe.

* tested at 23 ±2°C

General

The patient is an intended operator.

Humidifier performance:

SlimLine/Standard tubing

Mask Pressure

cm H2O (hPa)

Nominal % RH when

delivered to mask at

72ºF (22ºC)

Nominal system output mg/L AH1, BTPS2

Nominal % RH

delivered to mask,

tested in at 72ºF (22ºC)

ambient

Setting 8^ (maximum

setting)

100%

100%

100%

Setting 4

≥6

≥6

≥6

Setting 4

80%

80%

80%

Setting 8 (maximum

setting)

≥12

≥12

≥12

4

10

20

English

21

Nominal % RH delivered to mask,

tested in 72ºF (22ºC) ambient

85%

85%

85%

Nominal system output mg/L

AH1, BTPS2

≥ 12

≥ 12

≥ 12

ClimateLineAir 11

60 to 86ºF (16 to 30ºC)

106ºF (41ºC)

25 cm H2O

-

Flexible plastic and electrical

components

0.6" (15 mm)

6'6" (2.0m)

SlimLine/ Standard

-

106ºF (41ºC)

25 cm H2O

106ºF (41ºC)

Flexible plastic

SlimLine: 0.6" (15 mm)

Standard: 0.74" (19 mm)

SlimLine: 6' (1.8m)

Standard: 6"6' (2.0m)

At flow (L/min) with pressure of

20 cm H2O

Resistance to flow (cm

H2O/L/min)

Air tubing only

30

15

30

15

30

15

0.0050

0.0040

0.007

0.006

0.0100

0.0077

Note: The manufacturer reserves the right to change these specifications without notice.

Resistance to flow

The table illustrates the resistance to flow of the air tubing:

Climate Control Auto2 - ClimateLineAir 11

Mask Pressure

cm H2O (hPa)

4

10

20

1 AH - Absolute Humidity in mg/L

2 BTPS - Body Temperature Pressure Saturated

Air tubing

ClimateLineAir 11 temperature pressure range

ClimateLineAir 11 temperature cut out

Maximum recommended pressure

Maximum working temperature, when used with a

humidifier

Material

22

Inner diameter

Length

Air tubing

Standard

SlimLine

ClimateLineAir

Compliance

The table illustrates the compliance of the air tubing:

Air tubing

Compliance (cm H2O/L/min) with pressure of 60 cm H2O

Standard (19mm) with length of 3m

SlimLine

ClimateLineAir

Air tubing only

1.056

0.454

0.500

Guidance and manufacturer’s declaration

electromagnetic emissions and immunity

WARNING

Portable RF communications equipment (including peripherals such as antenna cables and external

antennas) should be used no closer than 3.9" (10 cm) to any part of the device. Otherwise,

degradation of the performance of this equipment could result.

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 AirSense device has been designed to meet EMC standards. However, should you suspect that the

device performance (eg, pressure or flow) is affected by other equipment, move the device away from the

possible cause of interference.

Guidance and manufacturer's declaration - electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The patient or the user

of the device should assure that the device is used in such an environment.

Emissions test

RF emissions CISPR 11

Compliance

Group 1

RF emissions CISPR 11

Class B

Harmonic Emissions

IEC 61000-3-2

Voltage Fluctuations/Flicker Emissions

IEC 61000-3-3

Class A

Complies

Electromagnetic environment — guidance

The device 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.

The device is suitable for use in all establishments,

including domestic establishments and those directly

connected to the public low-voltage network that supplies

buildings used for domestic purposes.

Guidance and manufacturer's declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the

user of the device should assure that the device is used in such an environment.

Immunity test

IEC60601-1-2 test

Compliance level

Electromagnetic environment — guidance

±8 kV contact

±15 kV air

±8 kV contact

±15 kV air

±2 kV

±1 kV for input/output

lines

Floors should be wood, concrete or ceramic tile. If floors

are covered with synthetic material, the relative humidity

should be at least 30%.

Mains power quality should be that of a typical

commercial or hospital environment.

Electrostatic

discharge (ESD)

IEC 61000-4-2

Electrical fast

transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips,

short

interruptions and

voltage

variations on

power supply

input lines

IEC 61000-4-11

±2 kV for power supply

lines

±1 kV for input/output

lines

±1 kV differential mode

±2 kV common mode

<5% Ut (>95% dip in

Ut) for 0.5 cycle

70% Ut (30% dip in Ut)

for 25 cycles

<5% Ut (>95% dip in

Ut) for 5 sec

±1 kV differential mode

±2 kV common mode

<5% Ut (>95% dip in Ut)

for 0.5 cycle

70% Ut (30% dip in Ut)

for 25 cycles

<5% Ut (>95% dip in Ut)

for 5 sec

Mains power quality should be that of a typical

commercial or hospital environment.

Mains power quality should be that of a typical

commercial or hospital environment.

If the user of the device requires continued operation

during power mains interruptions, it is recommended that

the device be powered from an uninterruptible power

source.

English

23

Immunity test

IEC60601-1-2 test

Compliance level

Electromagnetic environment — guidance

3 A/m

30 A/m

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

Conducted RF

IEC 61000-4-6

6 Vrms

150 kHz to 80 MHz

6 Vrms

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

9 V/m to 28 V/m at

frequencies up to 5.785

GHz

27 V/m to 85 V/m at

frequencies up to 5.785

GHz

Power frequency magnetic fields should be at levels

characteristic of a typical location in a typical commercial

or hospital environment.

Portable and mobile RF communications equipment should

be used no closer to any part of the device, including

cables, than the recommended separation distance

calculated from the equation applicable to the frequency

of the transmitter.

The device complies with all applicable electromagnetic

compatibility requirements (EMC) according to IEC60601-

1-2:2014, for residential, commercial and light industry

environments. Portable and mobile RF communications

equipment should be used no closer to any part of the

device including cables, than the recommended 3.9" (10

cm) separation distance.

The device has been designed to meet EMC standards.

However, should you suspect that the device performance

(eg pressure or flow) is affected by other equipment, move

the device away from the possible cause of interference.

Operation is subject to the following two conditions: This

device may not cause harmful interference, and this

device must accept any interference received including

interference that may cause undesired operation.

Notes:

• Ut is the AC mains voltage prior to application of the test level.

• At 80 MHz and 800 MHz, the higher frequency range applies.

• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection

from structures, objects and people.

Symbols

Follow instructions before use.

Temperature limitation.

Humidity limitation.

Operating

altitude.

Atmospheric pressure limitation.

Manufacturer.

Direct current.

On / Off.

Class II equipment.

Protected against finger sized objects and against dripping water when tilted

up to 15 degrees from specified orientation.

Non-ionising radiation.

MR unsafe (do not use in the

vicinity of an MRI device).

RTCA/DO-160 Section 21, Category M Compliant & FAA Compliant.

Type

BF applied part.

Date of Manufacture

Medical device.

Catalog number.

Device

number.

Batch code.

Serial number.

See symbols glossary at ResMed.com/symbols.

European Authorized Representative.

Environmental information

This device should be disposed of separately, not as unsorted municipal waste. To dispose of your device,

you should use appropriate collection, reuse and recycling systems available in your region. The use of

these collection, reuse and recycling systems is designed to reduce pressure on natural resources and

prevent hazardous substances from damaging the environment.

If you need information on these disposal systems, please contact your local waste administration. The

crossed-bin symbol invites you to use these disposal systems. If you require information on collection and

disposal of your ResMed device please contact your ResMed office, local distributor or go to

ResMed.com/environment.

24



California Perchlorate Information:

The coin-cell battery within this device may contain Perchlorate Material - special handling may apply.

See: www.dtsc.ca.gov/hazardouswaste/perchlorate

Servicing

The AirSense device is intended to provide safe and reliable operation when operated in accordance with

the instructions provided by ResMed. ResMed recommends that the AirSense device be inspected and

serviced by an authorized ResMed Service Centre if there is any sign of wear or concern with device

function. Otherwise, service and inspection of the products generally should not be required during their

design life.

Limited warranty

ResMed Pty Ltd (hereafter 'ResMed') warrants that your ResMed product shall be free from defects in

material and workmanship from the date of purchase for the period specified below.

• Mask systems (including mask frame, cushion, headgear and tubing)—excluding single-

90 days

Warranty period

Product

use devices

1 year

2 years

6 months

Flex-type finger pulse sensors

• Accessories—excluding single-use devices

•

• Humidifier water tubs

• Batteries for use in ResMed internal and external battery systems

• Clip-type finger pulse sensors

• CPAP and bilevel device data modules

• Oximeters and CPAP and bilevel device oximeter adapters

• Humidifiers and humidifier cleanable water tubs

• Titration control devices

• CPAP, bilevel and ventilation devices (including external power supply units)

• Battery accessories

• Portable diagnostic/screening devices

This warranty is only available to the initial consumer. It is not transferable.

During the warranty period, if the product fails under conditions of normal use, ResMed 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 improper use, abuse,

modification or alteration of the product; b) repairs carried out by any service organization that has not been

expressly authorized by ResMed to perform such repairs; c) any damage or contamination due to cigarette,

pipe, cigar or other smoke; and d) any damage caused by exposure to ozone, activated oxygen or other

gasses.

Warranty is void on product sold, or resold, outside the region of original purchase.

Warranty claims on defective product must be made by the initial consumer at the point of purchase.

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.

ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted

from the sale, installation or use of any ResMed product. Some regions or states do not allow the

exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to

you.

This warranty gives you specific legal rights, and you may also have other rights which vary from region to

region. For further information on your warranty rights, contact your local ResMed dealer or ResMed

office.

English

25



Visit ResMed.com for the latest information on ResMed's Limited Warranty.

Further information

If you require additional information on how to setup, use or maintain the Air11™ system (including

ClimateLineAir 11 heated tubing), or to report unexpected operation or events, please contact the ResMed

Service Centre or your care provider.

26

ResMed Pty Ltd

1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. Air11, AirSense, AutoSet, ClimateLine, ClimateLineAir, HumidAir, SlimLine and SmartStart are

trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip.

SD Logo is a trademark of SD-3C, LLC. Google Play and the Google Play logo are trademarks of Google LLC. The Bluetooth® word mark and logos are

registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by ResMed is under license. Apple and the Apple logo are trademarks of

Apple Inc., registered in the U.S and other countries. App Store is a service mark of Apple Inc. © 2021 ResMed. 398001/1 2021-01

ResMed.com ENGLISH

FCC information (4G)

This document provides additional information regarding compliance of the AirSense 11device with FCC Rules and

Industry Canada Rules.

FCC ID: 2ACHL-AIR114G

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

• This device may not cause harmful interference,

• This device must accept any interference received, including interference that may cause undesired operation.

This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy

set by the Federal Communications Commission of the U.S. Government and Industry Canada.

The exposure standard employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit

relevant for the application described in the manual is 1.6W/kg. Tests for SAR are conducted using standard operating

positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency

bands. Although the SAR is determined at the highest certified power level, the actual SAR level of the equipment while

operating can be well below the maximum value. This is because the device is designed to operate at multiple power

levels so as to use only the power required to reach the network. In general, the closer you are to a wireless base

station antenna, the lower the power output.

Equipment Authorization has been granted to this model with the reported SAR level(s) evaluated as in compliance with

the FCC RF exposure guidelines. SAR information on this equipment is on file with the FCC and can be found under the

Display Grant section of www.fcc.gov/oet/ea/fccid after searching on the FCC ID as printed on the equipment.

This device has been tested to comply with FCC and IC radiation exposure limits set forth for an uncontrolled

environment when used for the documented intended purpose and when mounted and operated as shown in the user

guide. The device has been tested for a minimum distance of 15 mm between the device and the human body.

This device complies with the FCC radiation exposure limits set forth in an uncontrolled environment.This equipment

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

equipment 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 equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

Increase the separation between the equipment and receiver,

• Reorient or relocate the receiving antenna,

•

• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected,

• Consult the dealer or an experienced radio/TV technician for help.

Any change or modification to the product is not expressly approved by ResMed and could void the user’s authority to

operate the device.

Industry Canada, IC: 9103A-AIR114G

This device complies with Industry Canada Rules. Operation is subject to the following two conditions:

• This device may not cause interference,

• This device must accept any interference, including interference that may cause undesired operation.

The device has been designed to comply with safety standards for exposure to radio waves (SAR) in accordance to

RSS-102.

FRANÇAIS

Renseignements relatifs à la FCC (4G)

Le présent document fournit des renseignements complémentaires relatifs à la conformité du dispositif

AirSense 11 aux règlements de la FCC et aux règles d’Industrie Canada.

ID FCC : 2ACHL-AIR114G

Cet appareil est conforme à la Section 15 des réglementations de la FCC. Son fonctionnement est soumis aux deux

conditions suivantes :

• Cet appareil ne doit pas causer de brouillage préjudiciable, et

• Cet appareil doit accepter tout brouillage subi, même si le brouillage est susceptible d’en compromettre le

fonctionnement.

Cet appareil est conçu et fabriqué afin de ne pas dépasser les limites d’émission pour une exposition à l’énergie des

fréquences radio telles qu’établies par la Commission fédérale des communications du gouvernement des États-Unis

(FCC) et par Industrie Canada.

La norme d’exposition est fondée sur une unité de mesure appelée Débit d’absorption spécifique ou SAR (Specific

Absorption Rate). Le SAR limite correspondant à l’utilisation décrite dans le manuel est de 1,6 W/kg. Les tests portant

sur le SAR sont effectués en utilisant les positions de fonctionnement standard acceptées par la FCC lorsque l’appareil

fonctionne à son niveau de puissance certifié le plus élevé dans toutes les bandes de fréquences testées. Bien que le

SAR soit déterminé au niveau de puissance certifié le plus élevé, le niveau de SAR réel de l’appareil en cours d’utilisation

peut être nettement inférieur à la valeur maximale. Cela est dû au fait que l’appareil est conçu pour fonctionner

à différents niveaux de puissance de manière à n’utiliser que la puissance nécessaire pour atteindre le réseau.

Généralement, plus vous êtes proche d’une antenne de station de base sans fil, plus la puissance de sortie est faible.

La FCC a accordé une autorisation de commercialisation de ce modèle d’appareil, confirmant la conformité des niveaux

SAR évalués avec les directives de la FCC relatives à l’exposition aux RF. Les renseignements relatifs au SAR pour cet

appareil sont conservés par la FCC et se trouvent dans la section Display Grant (Afficher l’autorisation) du site

www.fcc.gov/oet/ea/fccid après avoir entré l’ID de la FCC apparaissant sur l’appareil dans le champ de recherche.

Cet appareil a été testé et respecte les limites d’expositions aux rayonnements établies par la FCC et IC pour un

environnement non contrôlé lorsqu’il est utilisé aux fins prévues, ainsi que monté et utilisé tel que décrit dans le guide

de l’utilisateur. L’appareil a été testé pour une distance minimale de 15 mm entre l’appareil et le corps humain.

Cet appareil est conforme aux limites d’exposition au rayonnement de la FCC comme indiquées pour un environnement

non contrôlé.

Cet appareil a été testé et respecte les exigences d’un appareil numérique de classe B, conformément à la Section

15 des réglementations de la FCC. Ces limites sont conçues pour procurer une protection raisonnable à l’égard du

brouillage préjudiciable dans le cadre d’une installation résidentielle. Cet équipement génère, utilise et peut rayonner de

l’énergie radiofréquence et peut causer un brouillage préjudiciable des communications radio, s’il n’est pas installé et

utilisé selon les instructions. Toutefois, rien ne garantit l’absence d’interférences dans une installation particulière. Si cet

équipement cause un brouillage préjudiciable à la réception des radiocommunications ou des programmes de télévision,

ce qui peut être vérifié en allumant et en éteignant l’appareil, l’utilisateur devra essayer de corriger la situation d’une de

ces façons :

• Réorienter ou déplacer l’antenne de réception.

• Éloigner l’équipement du récepteur.

• Brancher l’appareil dans une prise reliée à un autre circuit que celui qui alimente le récepteur.

• Communiquer avec le distributeur ou avec un technicien radio/TV expérimenté pour obtenir de l’aide.

Des changements ou des modifications non expressément approuvés par ResMed peuvent annuler le droit d’usage de

l’appareil de l’utilisateur.

Industrie Canada, IC : 9103A-AIR114G

Le présent appareil est conforme aux règles d’Industrie Canada. L’exploitation est autorisée aux deux conditions

suivantes :

• Cet appareil ne doit pas produire de brouillage, et

• L’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en

compromettre le fonctionnement.

Cet appareil a été conçu pour respecter les normes de sécurité relatives aux ondes radioélectriques (DAS)

conformément à la norme RSS-102.

ResMed Pty Ltd

1 Elizabeth Macarthur Drive

Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. For patent and other intellectual property information, see ResMed.com/ip.

AirSense is a trademark and/or registered trademark of the ResMed family of companies. © 2020 ResMed. 398120/1 2020-12

ResMed.com

 

 

 

 

 

 

 

 

 

 

SPECIFICATION

FCC & ISED Labelling Submission Air 11

ResMed Confidential

Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

© 2021 ResMed.

SPEC NO.

REV

PAGE

eLB1392-074

4.0

OF 4

Melanie Webster

22 February 2021

SPECIFICATION

FCC & ISED Labelling Submission Air 11

ResMed Confidential

Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

© 2021 ResMed.

SPEC NO.

REV

PAGE

eLB1392-074

4.0

OF 4

Melanie Webster

22 February 2021

SPECIFICATION

FCC & ISED Labelling Submission Air 11

ResMed Confidential

Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

© 2021 ResMed.

SPEC NO.

REV

PAGE

eLB1392-074

4.0

OF 4

Melanie Webster

22 February 2021

SPECIFICATION

FCC & ISED Labelling Submission Air 11

ResMed Confidential

Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

© 2021 ResMed.

SPEC NO.

REV

PAGE

eLB1392-074

4.0

OF 4

Melanie Webster

22 February 2021



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ResMed Date: January 20, 2021 Re: Declaration about validity of test results from testing/certification of the integrated module ResMed Pty Ltd, 1 Elizabeth Macarthur Dr, Bella Vista NSW 2153, Australia Related to product:

Type of Equipment: Continuous Positive Airway Pressure (CPAP) Device Brand name: ResMed Model name: 39420, 39421, 39422, 39423, 39424, 39425 Commercial name: AirSense 11 FCC ID: 2ACHL-AIR114G IC: 9103A-AIR114G To whom it may concern, We declare that the ELS61-US module has not been modified and has been integrated following modules manufacturer instructions for the installation such as input voltages considering extreme voltages, driver software, environmental conditions, etc... Then, the results from conducted test reports according to FCC and ISED standards supplied by THALES DIS AIS Deutschland GmbH of module ELS61-US with FCC /D QIPEL61-US and IC 7830A-ELS61US remain applicable, valid and representative of the module and are representative under the new conditions for the certification of the host device, AirSense 11

- Test report for FCC Parts 2, 22, 24, 27: ULO5420151102FCC/IC042-1 dated on 6-Nov-2015.

- Test report for FCC Parts 2, 22, 24, 27: ULO5420151102FCC/IC042-2 dated on 28-Nov-2015

- Test report for RSS-GEN, 132,133,139: 201119018RFM-1 dated on 10-Dec-2020.

- Test report for RSS-GEN, 130,132,133,139: 201119018RFM-2 dated on 10-Dec-2020. Sincerely, By: Christopher Jenkins Title: Associate Manager Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1517 e-mail: Christopher. Jenkins@resmed.com.au ResMed Pty Limited 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia T +61 (2) 8884 1517 christopher.jenkins@resmed.com.au ABN 30 003 765 142 ResMed.com

 

 

ResMed Federal Communications Commission Equipment Authorization Division 7435 Oakland Mills Road Columbia, MD 21048 Date: 14 December 2020 Ref: Agent letter for FCC ID: 2ACHL-AIR114G ResMed Pty Ltd, 1 Elizabeth Macarthur Dr, Bella Vista NSW 2153, Australia hereby authorize DEKRA Testing and Certification, S.A.U., C/ Severo Ochoa, 2 & 6, 29590 Campanillas Malaga, Spain Mr. Eduardo Pavia Rubio, e-mail: eduardo.pavia@dekra.com, Phone: +34 95 261 91 25 to act as our agent in the preparation of this application for equipment certification, including the signing of all documents relating to these matters. The present authorization considers the development of documents on behalf of the client, written under his own letterhead and related to the necessary information to be provided on his behalf to complete the certification process. We also hereby certify that neither we nor any party to this application are subject to a denial of U.S. Federal benefits, which include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, U.S.C. 862 because of conviction for possession or distribution of controlled substance. For instances where our authorized agent signs the application for certification on our behalf, we acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by DEKRA Testing and Certification, S.A.U., still resides with us. This agreement expires one year from the current date. Sincerely, By: Christopher Jenkins Title: Associate Manager Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1517 e-mail: Christopher.Jenkins@resmed.com.au ResMed Pty Limited 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia T +61 (2) 8884 1517 E christopher.jenkins@resmed.com.au ABN 30 003 765 142 ResMed.com

 

 

ResMed Changing lives with every breath Date: 2-Feb-2021 Federal Communications Commission Equipment Authorization Division 7435 Oakland Mills Road Columbia, MD 21048 Ref: Confidentiality request for FCC ID: 2ACHL-AIR114G To whom it may concern:

Pursuant to 0.457(d)(1)(ii) and 0.459 of the Commissions Rules (47 C.F.R.) and 552 (b)(4) of the Freedom of Information Act, ResMed Pty Ltd hereby request requests that a part of the subject FCC application be held confidential to avoid release of sensitive information of the product to the public. For the product stated above, we request that the following information be withheld from public disclose:

Type of Confidentiality Requested Exhibit

[-] Short Term X] Permanent Block Diagrams XX] Short Term External Photos XX] Short Term Internal Photos

[_] Short Term X] Permanent Operation Description

(_] Short Term XJ Permanent Parts List & Placement/BOM L_] Short Term XJ Permanent Tune-Up Procedure

(_] Short Term X] Permanent Schematics x] Short Term Test Setup Photos XX] Short Term User's Manual Permanent Confidentiality:

The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to us and provide unjustified benefits to our competitors. Short-Term Confidentiality:

We hereby request short-term confidentiality for the product stated above to avoid premature release of sensitive information prior to marketing or release of the product to the public. Release date of short term confidentiality is:

45 days from grant date marked 90 days from grant date marked 135 days from grant date marked 180 days from grant date marked Specific date:

HOOO We are also aware that we are responsible to notify DEKRA in the event information regarding the product or the product is made available to the public. DEKRA will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, By: Christopher Jenkins Title: Associate Manager Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1000 e-mail: Christopher.Jenkins@resmed.com.au ResMed Pty Ltd 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia T +61 2 8884 1000 E Christopher.jenkins@ResMed.com.au ResMed.com