ResMed AirSense 10 AutoSet for Her Plus User manual

Clinical guide
English
Clinical guide

i
Contents
Welcome ...................................................................................................................................1
Indications for use................................................................................................................1
AirSense 10 AutoSet Plus ..............................................................................................1
AirSense 10 AutoSet for Her Plus ..................................................................................1
AirSense 10 Elite Plus....................................................................................................1
Contraindications..................................................................................................................1
Adverse effects....................................................................................................................2
At a glance ................................................................................................................................2
About the control panel ...........................................................................................................3
Therapy information.................................................................................................................4
AutoSet mode......................................................................................................................4
Normal airway................................................................................................................4
Flow limitation ...............................................................................................................5
Snore .............................................................................................................................5
Apnea ............................................................................................................................5
AutoSet for Her mode..........................................................................................................7
CPAP mode..........................................................................................................................7
Reporting .............................................................................................................................8
Central sleep apnea detection........................................................................................8
Cheyne-Stokes respiration detection..............................................................................8
Respiratory effort related arousals reporting ..................................................................9
Comfort features.....................................................................................................................10
Ramp .................................................................................................................................10
Expiratory Pressure Relief ..................................................................................................10
AutoSet Response .............................................................................................................11
Climate Control ..................................................................................................................11
Climate Control Auto....................................................................................................11
Tube Temperature .......................................................................................................11
Climate Control Manual................................................................................................11
Tube Temperature .......................................................................................................11
Humidity Level.............................................................................................................12
Setup.......................................................................................................................................13
Supplemental oxygen.........................................................................................................14
Antibacterial filters .............................................................................................................14
Accessing and exiting the Clinical Menu...............................................................................14
Adjusting the clinical settings .............................................................................................15
Setting the date and time.............................................................................................15
Settings menu....................................................................................................................16
Therapy........................................................................................................................16
Comfort .......................................................................................................................16
Accessories .................................................................................................................17
Options ........................................................................................................................17
Configuration ...............................................................................................................18
Starting therapy......................................................................................................................19
Stopping therapy....................................................................................................................19
Viewing the Sleep Report...................................................................................................19
Sleep Report screen parameters........................................................................................20
Cleaning and Maintenance ....................................................................................................21
Disassembling....................................................................................................................21

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Cleaning ............................................................................................................................ 21
Checking ........................................................................................................................... 22
Reassembling.................................................................................................................... 22
Reprocessing.......................................................................................................................... 22
Surface disinfection ........................................................................................................... 23
Reprocessing the air tubing and Air10 tubing elbow .......................................................... 23
Disconnecting ............................................................................................................. 23
Decontaminating ......................................................................................................... 24
Disinfecting ................................................................................................................. 24
Inspecting ................................................................................................................... 25
Reconnecting the air tubing......................................................................................... 25
Packaging and storage................................................................................................. 25
Reprocessing the humidifier and air outlet......................................................................... 26
Disassembling............................................................................................................. 26
Decontaminating ......................................................................................................... 27
Disinfecting ................................................................................................................. 27
Inspecting ................................................................................................................... 28
Reassembling.............................................................................................................. 28
Packaging and storage................................................................................................. 29
Data management and therapy compliance ........................................................................ 29
SD card.............................................................................................................................. 29
Data storage...................................................................................................................... 30
Managing patient care........................................................................................................... 30
Patient menu ..................................................................................................................... 30
Traveling............................................................................................................................ 30
Traveling by plane........................................................................................................ 31
Troubleshooting..................................................................................................................... 31
General troubleshooting .................................................................................................... 31
Device messages .............................................................................................................. 33
General warnings and cautions ............................................................................................ 34
Technical specifications......................................................................................................... 35
Symbols ............................................................................................................................ 39
Servicing............................................................................................................................ 39
Limited warranty................................................................................................................ 40

English 1
Welcome
The AirSense™10 AutoSet™Plus and AirSense 10 AutoSet for Her Plus are ResMed's premium
auto-adjusting pressure devices. The AirSense 10 Elite Plus is ResMed's Continuous Positive Airway
Pressure (CPAP) devices.
WARNING
•Read this entire guide before using the device.
•Use the device according to the intended use provided in this guide.
•The advice provided by your prescribing doctor should be followed ahead of the
information provided in this guide.
Indications for use
AirSense 10 AutoSet Plus
The AirSense 10 AutoSet Plus self-adjusting device is indicated for the treatment of obstructive
sleep apnea (OSA) in patients weighing more than 30 kg. It is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a
hospital/institutional environment.
AirSense 10 AutoSet for Her Plus
The AirSense 10 AutoSet for Her Plus self-adjusting device is indicated for the treatment of
obstructive sleep apnea (OSA) in female patients with mild to moderate OSA weighing more than
30 kg. It is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a
hospital/institutional environment.
AirSense 10 Elite Plus
The AirSense 10 Elite Plus device is indicated for the treatment of obstructive sleep apnea (OSA) in
patients weighing more than 30 kg. It is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a
hospital/institutional environment.
Contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following
pre-existing conditions:
•severe bullous lung disease
•pneumothorax
•pathologically low blood pressure
•dehydration
•cerebrospinal fluid leak, recent cranial surgery, or trauma.

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Adverse effects
Patients should report unusual chest pain, severe headache, or increased breathlessness to their
prescribing physician. An acute upper respiratory tract infection may require temporary
discontinuation of treatment.
The following side effects may arise during the course of therapy with the device:
•drying of the nose, mouth, or throat
•nosebleed
•bloating
•ear or sinus discomfort
•eye irritation
•skin rashes.
At a glance
The AirSense 10 Plus includes the following:
•Device
•HumidAir™humidifier
•Air tubing
•Power supply unit
•Travel bag
•SD card (already inserted).
A range of accessories are available for use with the device including:
•Air tubing (heated and non-heated): ClimateLineAir™, SlimLine™, ClimateLineAir Oxy, Standard
•Side cover for use without the humidifier
•Filter: Hypoallergenic filter, standard filter
•Air10™ DC/DC converter (12V/24V)
•SD card reader
•Air10 oximeter adapter
•Air10 USB adapter
•Power Station II
•Air10 tubing elbow.
Note: Make sure all parts and accessories used with the device are compatible. For compatibility
information, refer to www.resmed.com.

English 3
1
Air outlet
5
HumidAir humidifier
2
Air filter cover
6
Screen
3
Power inlet
7
Adapter cover
4
Serial number and device number
8
SD card cover
About the control panel
Start/Stop button
Press to start/stop therapy.
Press and hold for three seconds to enter power save
mode.
Dial
Turn to navigate the menu and press to select an option.
Turn to adjust a selected option and press to save your
change.
Home button Press to return to the Home screen.
Different icons may be displayed on the screen at different times including:
Ramp Time Wireless signal strength (green)
Ramp Time Auto
Wireless transfer not enabled (gray)
Humidity No wireless connection
Humidifier warming Airplane Mode
Humidifier cooling

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Therapy information
The following modes are available on the AirSense 10 Plus device:
Device
Modes available
AutoSet
AutoSet for Her
CPAP
AirSense 10 AutoSet Plus  
AirSense 10 AutoSet for Her
Plus   
AirSense 10 Elite Plus 
AutoSet mode
The treatment pressure required by the patient may vary due to changes in sleep state, body
position and airway resistance. In AutoSet mode, the device provides only that amount of pressure
required to maintain upper airway patency.
The device analyzes the state of the patient’s upper airway on a breath-by-breath basis and delivers
pressure within the allowed range according to the degree of obstruction. The AutoSet algorithm
adjusts treatment pressure as a function of three parameters: inspiratory flow limitation, snore, and
apnea.
Normal airway
When the patient is breathing normally, the inspiratory flow measured by the device as a function of
time shows a typically rounded curve for each breath.

English 5
Flow limitation
As the upper airway begins to collapse, the shape of the inspiratory flow-time curve changes. The
AirSense 10 Plus recognizes and treats traditional as well as less common flow-limited breath wave
forms.
Snore
Snoring is sound generated by vibrations of the walls of the upper airway. It is often preceded by
flow limitation or a partial obstruction of the airway.
Apnea
The enhanced AutoSet algorithm detects both obstructive and central apneas. If an apnea occurs,
the device responds appropriately.

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Obstructive apnea
An obstructive apnea is when the upper airway becomes severely limited or completely obstructed.
AutoSet generally prevents obstructive apneas from occurring by responding to flow limitation and
snoring. If an obstructive apnea occurs, the device will respond by increasing pressure.
Central apnea
During a central apnea, the airway will remain open, but there is no flow. When a central apnea is
detected, the device responds appropriately by not increasing pressure.

English 7
AutoSet for Her mode
AutoSet for Her mode is based on key aspects of ResMed’s AutoSet algorithm and delivers
therapeutic responses tailored to the characteristics of female OSA patients.
The AutoSet for Her is similar to ResMed’s AutoSet algorithm with the following modifications:
•Reduced rate of pressure increments designed to help prevent arousals.
•Slower pressure decays.
•Treats apneas up to 12 cm H2O (12 hPa) and continues to respond to flow limitation and snore up
to 20 cm H2O (20 hPa).
•Minimum pressure (Min. Pressure) that adjusts according to the frequency of apneas:
If two apneas occur within a minute, the pressure reached in response to the second apnea will
become the new minimum treatment pressure until the next treatment session.
Patients who use AutoSet for Her will still get the benefits of ResMed's AutoSet technology
including improved sensitivity to flow-limitation and Central Sleep Apnoea Detection with Forced
Oscillation Technique.
CPAP mode
In CPAP mode, a fixed pressure is delivered—with optional Expiratory Pressure Relief (EPR™).

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Reporting
The AirSense 10 detects Central Sleep Apnea (CSA) and Cheyne-Stokes Respiration (CSR). The
Summary and Detailed Data of these parameters are available to view on ResMed patient
compliance software (data availability depends on device mode and parameter measured).
Central sleep apnea detection
Available in all modes on the AirSense 10 AutoSet Plus, AirSense 10 AutoSet for Her Plus and the
AirSense 10 Elite Plus.
The device detects both obstructive and central sleep apneas (CSA). CSA detection uses the Forced
Oscillation Technique (FOT) to determine the state of the patient’s airway during an apnea. When an
apnea has been detected, small oscillations in pressure [1 cm H2O (1 hPa) peak-to-peak at 4 Hz] are
added to the current device pressure. The CSA detection algorithm uses the resulting flow and
pressure (determined at the mask) to measure the airway patency.
Cheyne-Stokes respiration detection
Available in all modes on the AirSense 10 AutoSet Plus, AirSense 10 AutoSet for Her Plus and the
AirSense 10 Elite Plus.
Cheyne-Stokes respiration (CSR) is a form of sleep-disordered breathing characterized by a periodic
waxing and waning of respiration. The waxing periods (hyperpneas, typically 40 seconds in length)
can include large gasping breaths that tend to arouse the patient while the waning periods
(hypopneas or apneas, typically 20 seconds in length) cause blood oxygen desaturations.
The following example shows a typical CSR period.

English 9
The following example suggests periodic breathing due to the frequently occurring apneas.
However, when looking closely at the shape of the hyperpneas it can be seen that it is a typical OSA
period.
The AirSense 10 Plus device reports the time during therapy in which it detected breathing patterns
indicative of CSR. It analyzes the patient's respiratory flow for apnea/hypopnea events, calculates
the time between these events, and characterizes the shape of breathing between them.
Respiratory effort related arousals reporting
Respiratory Effort Related Arousals (RERA) reporting is available on the AirSense 10 AutoSet for Her
Plus in all modes.
RERAs are periods of increasing respiratory effort which are terminated by an arousal. Increasing
respiratory effort will be seen as airflow limitation.These flow-based RERA events are logged and
stored as summary and/or detailed data and can then be viewed in one of ResMed's patient
management systems.

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Comfort features
Ramp
Designed to make the beginning of treatment more comfortable, ramp is available in all modes.
In AutoSet mode, ramp time defines the period during which the pressure gradually increases from
a lower more comfortable start pressure to the minimum treatment pressure before the
auto-adjusting algorithm commences.
In CPAP mode, the pressure increases from a low pressure (Start Pressure) to the prescribed
treatment pressure.
Ramp Time can be set to Off, 5 to 45 minutes or Auto. When Ramp Time is set to Auto, the device
will detect sleep onset and then gradually increase from the start pressure to the minimum
treatment pressure at a rate of 1 cm H2O (1 hPa) per minute. However, if sleep onset is not
detected, the device will reach the target pressure within 30 minutes.
Expiratory Pressure Relief
Designed to make therapy more comfortable, Expiratory Pressure Relief (EPR) maintains optimal
treatment for the patient during inhalation and reduces the delivered mask pressure during
exhalation.
EPR
On—EPR is enabled.
Off—EPR is disabled.
The following settings are only available if EPR is On:
EPR Type
Full Time—If set to Full Time, EPR is enabled for the whole therapy session.
Ramp Only—If set to Ramp Only, EPR is only enabled during ramp time.
EPR Level
1, 2, 3 cm H
2
O (1, 2, 3 hPa)
When EPR is enabled, the delivered pressure will not drop below a minimum pressure of 4 cm H2O
(4 hPa), regardless of the settings.

English 11
AutoSet Response
AutoSet mode (AirSense 10 AutoSet Plus device only).
For patients who are sensitive to faster changes in pressure during therapy, AutoSet Response can
be set to either Standard or Soft. If set to soft, patients will receive gentler pressure rises during
therapy.
Patients who use the AutoSet Response feature will still get the benefits of ResMed's AutoSet
technology including improved sensitivity to flow-limitation and CSA Detection with Forced
Oscillation Technique.
Climate Control
Climate Control is an intelligent system that controls the humidifier and the ClimateLineAir heated
air tubing to deliver constant, comfortable temperature and humidity levels during therapy.
Designed to prevent dryness of the nose and mouth, it maintains the set temperature and relative
humidity while you sleep. Climate Control can be set to either Auto or Manual and is only available
when both the ClimateLineAir and the HumidAir humidifier are attached.
Climate Control Auto
Climate Control Auto is the recommended and default setting. Climate Control Auto is designed to
make therapy as easy as possible, so there is no need to change the temperature or humidity
settings.
Climate Control adjusts the humidifier output to maintain a constant, comfortable humidity level of
85% relative humidity while protecting against rainout (water droplets in the air tubing and mask).
Tube Temperature
In Climate Control Auto there is no need to change any settings, but if the air in the mask is too
warm or cold for the patient, the tube temperature can be adjusted. The Tube Temperature can be
set to anywhere between 16–30°C, or turned off completely.
Climate Control Manual
Designed to offer more flexibility and control over settings, Climate Control Manual lets the patient
adjust the temperature and humidity to the setting which is most comfortable for them.
In Climate Control Manual, the Tube Temperature and the Humidity Level can be set independently
however, rainout protection is not guaranteed. If rainout does occur, first try increasing the tube
temperature. If the air temperature becomes too warm and rainout continues, try decreasing the
humidity.
Tube Temperature
If the air in the mask feels too warm or too cold, the patient can adjust the temperature to find what
is most comfortable or turn it off completely. The Tube Temperature can be set to anywhere
between16–30°C.
The temperature sensor located at the mask end of the ClimateLineAir heated air tubing enables the
system to automatically control the temperature of the air delivered to the patient. This ensures the
temperature of the air delivered to the patient does not fall below the set minimum temperature,
therefore maximizing breathing comfort for the patient.

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Humidity Level
The humidifier moistens the air and is designed to make therapy more comfortable. If the patient is
getting a dry nose or mouth, turn up the humidity. If the patient is getting moisture in their mask,
turn down the humidity.
The Humidity Level can be set to Off or between 1 and 8, where 1 is the lowest humidity setting
and 8 is the highest humidity setting.
For each humidifier setting, the Climate Control system delivers a constant amount of water vapor,
or absolute humidity (AH), to the patient’s upper airway.
Automatic adjustment
The humidifier and ClimateLineAir heated air tubing are controlled by the Climate Control algorithm
to deliver constant humidity and temperature outputs. The system adjusts automatically to changes
in:
•ambient room temperature and humidity values
•flow due to pressure changes
•flow due to mask or mouth leak.

English 13
Setup
CAUTION
Do not overfill the humidifier as water may enter the device and air tubing.
1. Place the device on a stable level surface.
2. Plug the power connector into the rear of the device. Connect one end of the power cord into
the power supply unit and the other end into the power outlet.
3. Connect the air tubing firmly to the air outlet located on the rear of the device.
4. Open the humidifier and fill it with water up to the maximum water level mark.
Do not fill the humidifier with hot water.
5. Close the humidifier 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 are available on www.resmed.com.

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Supplemental oxygen
The AirSense 10 Plus device is designed to be compatible with up to 4 L/min of supplemental
oxygen in all modes.
At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary depending
on the pressure settings, patient breathing pattern, mask selection and the leak rate.
To connect supplemental oxygen to the device you need to connect an oxygen connector port. For
more information on how to set up the device with supplemental oxygen, refer to the user guide
supplied with that accessory.
Notes:
•Adding oxygen may affect the delivered pressure and the accuracy of the displayed leak and
minute ventilation.
•Before adding oxygen, familiarize yourself and your patient with the specific warnings relating to
the use of supplemental oxygen. These can be found at the end of this guide.
Antibacterial filters
Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and
delivered pressure, particularly at high flows.
ResMed recommends using an antibacterial filter with a low impedance [eg, 2 cm H2O (2 hPa) at
60 L/min], such as PALL (BB50T), Filter without Luer Port (4222/702) or the Filter with Side Port
24966 (4222/701). If using the Filter with Side Port, an Oxygen Connector Port is required.
Accessing and exiting the Clinical Menu
You can access, view and set parameters relating to a patient's therapy and device configuration in
the Clinical Menu.
To access the Clinical Menu:
•Press and hold the dial and the Home button for three seconds.
The Home screen is displayed with an unlock icon in the top right corner of the screen.
To exit the Clinical Menu:
•Press and hold the dial and the Home button for three seconds.
•Select Exit Clinical Menu from the Home screen.
The device will automatically exit the Clinical Menu after 20 minutes of inactivity.

English 15
Adjusting the clinical settings
1. Access the Clinical Menu, highlight Settings and press the dial.
The Settings menu is displayed.
2. Turn the dial to highlight the setting you want to adjust and then press the dial.
3. Turn the dial to adjust the setting and press the dial to save the change.
The settings can be changed in different ways depending on the type of screen:
Turn the dial to edit live in the
menu.
Turn the dial to change the
setting.
Select from a list of options.
Setting the date and time
Before you set up a new patient and start therapy for the first time, make sure you set the correct
local date and time on the device. If you set the date and time after starting therapy, you may lose
patient data.
1. In Settings menu, select Date and change the setting to the correct date.
2. Select Time and change it to the correct local time.
3. Make sure the correct local time and date has been applied.

16
The AirSense 10 Plus settings must be configured for each individual patient. The settings should be
periodically reassessed to ensure optimal therapy.
Settings menu
You set all parameters relating to a patient's therapy and device configuration in the Settings menu.
Therapy
Parameter
Description
Mode
Range
AutoSet
AutoSet
for Her
CPAP
Mode Sets the therapy mode available
on the device.
  
Min Pressure Sets the lower limit of treatment
pressure.
  4–Max cm H2O (hPa),
0.2 cm H2O (hPa) increments
Max Pressure Sets the upper limit of treatment
pressure.
  Min–20 cm H2O (Min–20 hPa),
0.2 cm H2O (0.2 hPa)
increments
Set Pressure Sets the fixed treatment
pressure.  4–20 cm H2O (4–20 hPa),
0.2 cm H2O (0.2 hPa)
increments
Mask Select the type of mask used by
the patient. Refer to Mask Device
Compatibility List on
www.resmed.com.
   Full Face / Nasal / Pillows
Comfort
Parameter
Description
Mode
Range
AutoSet
AutoSet
for Her
CPAP
Response Sets the rate of pressure rises
during therapy.
 Standard / Soft
Ramp Time If Auto is selected, the device
will detect sleep onset and
automatically rise to the
prescribed treatment pressure.
   Off / 5–45 mins / Auto
Start
Pressure
Set the pressure at the start of
ramp, up to treatment pressure.
   4–Set pressure, 0.2 cm H2O
(0.2 hPa) increments
EPR Enable / disable EPR.



On / Off
EPR Type Available when EPR is enabled.



Full Time / Ramp Only
EPR Level Set the EPR value.



1 / 2 / 3 cm H2O (1 / 2 / 3 hPa)
Climate Ctrl Available when water tub is used
and ClimateLineAir heated air
tubing is connected.
   Manual / Auto

English 17
Parameter
Description
Mode
Range
AutoSet
AutoSet
for Her
CPAP
Tube Temp. Set the minimum temperature of
air delivered by heated air tubing
such as ClimateLineAir.
   Off /16–30°C, 1° increments
Humidity
Level
Set the humidity level.    Off / 1–8
Accessories
Parameter
Description
Range
Tube Select the type of air tubing used by the patient. ClimateLineAir air tubing
is automatically detected when connected to the device.
SlimLine / Standard
AB filter Select Yes if you attach an antibacterial filter. No / Yes
View
oximeter
Displayed at all times when an oximeter is connected. 18-300 BPM
0-100% SpO2
Options
Parameter
Description
Range
Essentials Set the level of access available to the patient. On / Plus
SmartStart™Enable / disable the SmartStart feature. If you enable the SmartStart
feature, the device will start automatically when the patient breathes into
the mask and then stop automatically when the patient removes the
mask.
Off / On
Reminders
Mask Set a recurring reminder to the patient to replace the mask. Off / 1– 24 mths, 1 month
increments
Humidifier Set a recurring reminder to the patient to replace the humidifier. Off / 1–24 mths, 1 month
increments
Tube Set a recurring reminder to the patient to replace the air tubing. Off / 1–24 mths, 1 month
increments
Filter Set a recurring reminder to the patient to replace the air filter. Off / 1–24 mths, 1 month
increments