ResMed AirCurve 10 ST-A User manual

Clinical guide
Clinical guide
English

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Contents
Welcome ...................................................................................................................................1
Indications for use................................................................................................................1
AirCurve 10 ST-A ...........................................................................................................1
Contraindications..................................................................................................................1
Adverse effects....................................................................................................................1
At a glance ................................................................................................................................2
About your device ................................................................................................................3
About the control panel ...........................................................................................................4
Therapy information.................................................................................................................5
CPAP mode..........................................................................................................................5
Bilevel modes ......................................................................................................................5
S (Spontaneous) mode...................................................................................................5
ST (Spontaneous/Timed) mode ......................................................................................5
T (Timed) mode..............................................................................................................5
PAC (Pressure Assist Control) mode..............................................................................5
iVAPS (intelligent Volume Assured Pressure Support) mode..........................................5
More about iVAPS................................................................................................................8
Target alveolar ventilation ..............................................................................................9
intelligent Backup Rate (iBR) ................................................................................................9
Triggering and cycling ........................................................................................................10
TiControl - Inspiratory time control .....................................................................................11
Rise time adjustment .........................................................................................................12
Leak management with VSync...........................................................................................12
Comfort features.....................................................................................................................12
Ramp .................................................................................................................................12
Ramp Down .......................................................................................................................13
Climate Control ..................................................................................................................13
Climate Control Auto....................................................................................................13
Climate Control Manual................................................................................................14
Setup.......................................................................................................................................15
Supplemental oxygen.........................................................................................................16
Antibacterial filters .............................................................................................................16
Accessing and exiting the Clinical Menu...............................................................................16
Adjusting the clinical settings .............................................................................................17
Setting the date and time.............................................................................................18
QuickNav ...........................................................................................................................18
Settings menu....................................................................................................................18
Therapy........................................................................................................................18
Comfort .......................................................................................................................20
Accessories .................................................................................................................21
Alarms .........................................................................................................................21
Options ........................................................................................................................22
Configuration ...............................................................................................................22
Configuring iVAPS ..............................................................................................................23
Using Learn Targets.....................................................................................................23
Entering the target values manually .............................................................................24
Working with alarms ..............................................................................................................24
Muting activated alarms .....................................................................................................24
Viewing the alarms.............................................................................................................25

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Alarm log ........................................................................................................................... 25
Alarm types ....................................................................................................................... 25
Testing the alarms ............................................................................................................. 25
Starting therapy ..................................................................................................................... 27
Stopping therapy ................................................................................................................... 27
Viewing the Sleep Report .................................................................................................. 28
Sleep Report screen parameters ....................................................................................... 28
Cleaning and Maintenance.................................................................................................... 30
Disassembling ................................................................................................................... 30
Cleaning ............................................................................................................................ 30
Checking ........................................................................................................................... 31
Reassembling.................................................................................................................... 31
Reprocessing.......................................................................................................................... 32
Surface disinfection ........................................................................................................... 32
Reprocessing the air tubing ............................................................................................... 33
Disconnecting ............................................................................................................. 33
Decontaminating ......................................................................................................... 33
Disinfecting ................................................................................................................. 33
High level chemical disinfection .................................................................................. 34
Inspecting ................................................................................................................... 34
Reconnecting the air tubing......................................................................................... 34
Packaging and storage................................................................................................. 34
Reprocessing the water tub and air outlet ......................................................................... 35
Disassembling............................................................................................................. 35
Decontaminating ......................................................................................................... 36
Disinfecting ................................................................................................................. 36
Inspecting ................................................................................................................... 37
Reassembling.............................................................................................................. 37
Packaging and storage................................................................................................. 38
Data management and therapy compliance ........................................................................ 38
Remote monitoring............................................................................................................ 38
SD card.............................................................................................................................. 38
Data storage...................................................................................................................... 39
Software upgrade.............................................................................................................. 40
Managing patient care........................................................................................................... 40
Patient menu ..................................................................................................................... 40
Therapy data...................................................................................................................... 40
Traveling............................................................................................................................ 41
Traveling by plane........................................................................................................ 41
Troubleshooting..................................................................................................................... 41
General troubleshooting .................................................................................................... 41
Alarms troubleshooting...................................................................................................... 44
General warnings and cautions ............................................................................................ 45
Technical specifications......................................................................................................... 47
Guidance and manufacturer’s declaration electromagnetic emissions and immunity ......... 52
Guidance and manufacturer’s declaration—electromagnetic emissions ...................... 52
Guidance and manufacturer’s declaration – electromagnetic immunity ....................... 52
Recommended separation distances between portable and mobile RF
communications equipment and the device ................................................................ 54
Symbols ............................................................................................................................ 54
Servicing............................................................................................................................ 55
Limited warranty................................................................................................................ 55

English 1
Welcome
The AirCurve™10 ST-A is a bilevel positive airway pressure device.
WARNING
Read this entire guide before using the device.
CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.
Indications for use
AirCurve 10 ST-A
The AirCurve 10 ST-A is indicated to provide non-invasive ventilation for patients weighing more
than 30 lb (13 kg) with respiratory insufficiency or obstructive sleep apnea (OSA).
The iVAPS mode is indicated for patients weighing more than 66 lb (30 kg).
The AirCurve 10 ST-A 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 or pneumomediastinum
•pathologically low blood pressure, particularly if associated with intravascular volume depletion
•dehydration
•cerebrospinal fluid leak, recent cranial surgery, or trauma.
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.

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At a glance
The AirCurve 10 includes the following:
•Device with HumidAir™integrated humidifier
•Water tub
•Air tubing
•Power supply unit
•Travel bag
•SD card (already inserted).
Contact your care provider for a range of accessories available for use with the device including:
•Air tubing (heated and non-heated): ClimateLineAir™, ClimateLineAir Oxy, SlimLine™, Standard
•Water tub: Standard water tub, cleanable water tub (can be disinfected)
•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
About your device
1
Air outlet
6
HumidAir humidifier (water tub)
2
Air filter cover
7
Screen
3
Retention clip
8
Adapter cover
4
Power inlet
9
SD card cover
5
Serial number and device number
10
LED alarm indicator

4
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)
Humidity Wireless transfer not enabled (gray)
Humidifier warming No wireless connection
Humidifier cooling Airplane Mode
Alarm muted

English 5
Therapy information
CPAP mode
In CPAP mode, a fixed pressure is delivered.
Bilevel modes
The AirCurve 10 device assists spontaneous breathing by cycling between two pressures in
response to the patient flow or a preset fixed time.
The inspiratory positive airway pressure (IPAP, or the sum of EPAP and the pressure support level)
assists inspiration.
The lower expiratory positive airway pressure (EPAP) facilitates exhalation comfort while providing a
splint to maintain an open upper airway.
The difference of the two pressures—pressure support (PS) level—contributes to improved patient
ventilation.
S (Spontaneous) mode
In S mode, you may set two treatment pressures-–one for inspiration (IPAP) and one for expiration
(EPAP). The device senses when the patient is inhaling and exhaling and supplies the pressures
accordingly. The difference between IPAP and EPAP levels helps determine the tidal volume.
ST (Spontaneous/Timed) mode
In ST mode, the device augments any breath initiated by the patient, but will also supply additional
breaths should the patient breath rate fall below the set Backup Rate.
T (Timed) mode
In T mode, a fixed breath rate and a fixed inspiration/expiration time are supplied regardless of
patient effort.
PAC (Pressure Assist Control) mode
The inspiration time is preset in the PAC mode. There is no spontaneous/flow cycling. The
inspiration can be triggered by the patient when respiratory rate is above a preset value, or time
triggered breath will be delivered at the set Backup Rate.
iVAPS (intelligent Volume Assured Pressure Support) mode
iVAPS is designed to maintain a preset target alveolar minute ventilation by monitoring delivered
ventilation, adjusting the pressure support and providing an intelligent backup breath automatically.
The iVAPS therapy mode is indicated for patients weighing 66 lb (30 kg) and above.

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The following diagram illustrates these operating modes.

English 7
The common adjustable parameters for different modes in the AirCurve 10 device are shown below.
Parameter
Mode
S
ST
T
PAC
iVAPS
CPAP
Set Pressure 
IPAP    
EPAP





Min PS 
Max PS 
Resp. Rate 
Backup Rate  
Target Pt Rate*  
Target Va 
Ti  
Ti Max   
Ti Min   
Rise Time





Trigger




Cycle   
Height 
*Only available when iBR is enabled in ST mode.

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More about iVAPS
You may prefer some assurance that the patient’s ventilatory needs will be defended if their
condition varies. A variety of ‘dual mode’ schemes exist, that aim to combine the benefits of
pressure target and volume target, most of which can be categorized generically as volume-assured
pressure support (VAPS) modes.
With VAPS devices in general, the ventilatory assistance (pressure support) aims to automatically
adjust to changes in patient condition over time, typically to maintain a target tidal volume.
iVAPS offers the comfort and synchrony of pressure support, but with the assurance offered by a
volume target. iVAPS has the following advantages over traditional VAPS schemes:
•iVAPS is a unique combination for a servo-controlled ventilator, in that iVAPS has the goal of
regulating alveolar ventilation to a prescribed target.
•iVAPS has an intelligent Backup Rate (iBR) which aims to keep ‘out of the way’ while the patient
is breathing, yet during sustained apnea will mimic the patient’s own breath rate. This
contributes to iVAPS’ ability to maintain its ventilation target and so stabilise blood gases even
during sleep.
•iVAPS has ResMed’s robust leak compensation algorithm (Vsync). This promotes synchrony and
comfort even during significant leak.

English 9
Target alveolar ventilation
iVAPS targets alveolar ventilation. Alveolar ventilation was chosen because gas exchange occurs at
the alveoli level. Total ventilation includes the ventilation devoted to the conducting airways,
whereas alveolar ventilation best represents the useful portion of ventilation that reaches the alveoli.
Alveolar ventilation cannot be measured directly, so iVAPS estimates it using a height approximated
value of anatomical deadspace as shown in the graph below. Anatomic deadspace is the amount of
breath that remains in the conducting airways, that does not reach alveoli and does not contribute to
gas exchange. Its contribution is proportional to breath rate. By using alveolar ventilation as a servo-
ventilation target, as opposed to tidal volume or minute ventilation, the effect of respiratory rate
change on effective ventilation is negated.
intelligent Backup Rate (iBR)
ST and iVAPS modes only
Instead of mandating a fixed backup rate, the intelligent Backup Rate (iBR) will shift automatically
between two limits.
During sustained apnoea, the iBR will adopt a pre-configured Target Patient Rate. This Target Patient
Rate defines the upper boundary for iBR. Set the Target Patient Rate to match the patient’s average
spontaneous rate (unlike a traditional backup rate).
During spontaneous ventilation, the iBR adjusts to remain in the background, at two-thirds of the
Target Patient Rate. This ‘background’ backup rate is lower than a traditional S/T rate, so gives the
patient maximum opportunity to spontaneously trigger.
When spontaneous triggering ceases (eg, at the onset of an apnoea/hypopnoea), the iBR adjusts
from its background frequency to its Target Patient Rate in iVAPS mode and adjusts quickest (within
4 to 5 breaths) when ventilation is below the target ventilation. In ST mode, iBR adjusts to the
Target Patient Rate at a fixed 5 breaths.
A single spontaneous triggered breath resets the iBR to its background rate (two-thirds of Target
Patient Rate).

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Triggering and cycling
S, ST and iVAPS modes only
The device has adjustable trigger/cycle sensitivity to optimize the sensing level according to patient
conditions.
Under normal conditions, the device triggers (initiates IPAP) and cycles (terminates IPAP and
changes to EPAP) as it senses the change in patient flow. Patient breath detection is enhanced by
ResMed's VSync automatic leak management.
Note: In PAC mode, only Triggering is available.

English 11
TiControl - Inspiratory time control
S, ST and iVAPS modes only
Unique to ResMed bilevel devices, TiControl™allows the clinician to set minimum and maximum
limits on the time the device spends in IPAP. The minimum and maximum time limits are set at
either side of the patient’s ideal spontaneous inspiratory time, providing a ’window of opportunity’
for the patient to spontaneously cycle to EPAP.
The minimum time limit is set via the Ti Min parameter and the maximum time limit is set via the Ti
Max parameter.
TiControl’s Ti Max and Ti Min parameters play a significant role in maximizing synchronization by
effectively intervening to limit or prolong the inspiratory time when required. This ensures
synchronization, even in the presence of significant mouth and/or mask leak.
The following table is a guide to selecting the Ti Max and Ti Min values that best correspond to the
patient’s respiratory rate and inspiration and expiration ratio, depending on the respiratory
conditions.
Patient breath
(BPM)
Ttot = 60/BPM
(sec)
I:E = 1:2
(Reference)
Sufficient inhalation time
I:E = 1:1
Secure
exhalation time
I:E = 1:3
Ti Min
Ti Max
Ti Max
10 6 2 1.0 2.0 1.5
15 4 1.3 1.0 2.0 1.3
20 3 1.0 0.8 1.5 1.0
25 2.4 0.8 0.7 1.2 0.8
30 2 0.7 0.6 1.0 0.7
35 1.7 0.6 0.5 0.8 0.7
40 1.5 0.5 0.5 0.7 0.7

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Rise time adjustment
S, ST, T, PAC and iVAPS modes
Rise Time sets the time taken for the device to reach IPAP. The greater the rise time value, the
longer it takes for pressure to increase from EPAP to IPAP.
Patients with a high ventilatory demand may prefer a shorter rise time, while patients who are slow
breathers may prefer a longer rise time.
Note: A prolonged rise time inhibits fast pressurization, therefore, rise time should not be set longer
than Ti Min or the patient's normal inspiratory time.
Leak management with VSync
Using ResMed's VSync algorithm, the AirCurve 10 device monitors and compensates for leak by
continuously and automatically adjusting the baseline flow. This enables reliable delivery of therapy
pressure while maintaining patient-device synchrony.
Comfort features
Ramp
Designed to make the beginning of treatment more comfortable, ramp is available in all modes.
In S, ST, T, PAC and iVAPS modes, the EPAP gradually increases from the Start EPAP to the
prescribed treatment pressure. Throughout Ramp, Pressure Support is maintained at the same level
as that set for treatment.
In iVAPS mode, Pressure Support is maintained at the minimum pressure support (Min PS).
In CPAP mode, the pressure increases from a low pressure (Start Pressure) to the prescribed
treatment pressure.

English 13
Ramp Down
S, ST, T, PAC and iVAPS modes
When stopping therapy, Ramp Down gives patients the option to gradually reduce pressure support
and EPAP, providing a more comfortable transition to spontaneous breathing. Ramp Down gradually
decreases the current pressure over a fixed 15 minute period until Start EPAP is reached. The
device remains in CPAP mode at Start EPAP until the Start/Stop button is pressed to turn off
therapy.
Patient access to Ramp Down is enabled via Essentials Plus.
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 during sleep. Climate Control can be set to either Auto or Manual and is only available
when 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 60–86°F (16–30°C), or turned off completely.
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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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.
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 15
Setup
CAUTION
Do not overfill the water tub as water may enter the device and air tubing.
1. With the device on a stable level surface, grip the retention clip on the back of the device and
pull up to open. Note: The retention clip is shown in the open position.
2. (a) Plug the power connector into the device power inlet then (b) push down the retention clip to
secure in place. 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 water tub and fill it with distilled water up to the maximum water level mark.
Do not fill the water tub with hot water.
5. Close the water 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 are available on www.resmed.com.
Note: Ensure the device is placed so that the LED alarm indicator is clearly visible.

16
Supplemental oxygen
The device is designed to be compatible with supplemental oxygen of up to 4 L/min in iVAPS mode
or up to 15 L/min in all other 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 can either connect a ClimateLineAir Oxy or 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), Air Safety Filter without Luer Port (4222/702) or Air Safety Filter
with Side Port 24966 (4222/701). If using the Air Safety Filter with Side Port, an Oxygen Connector
Port is required.
Note: When using the SlimLine air tubing above 20 cm H2O (20 hPa), the device optimum
performance may not be reached if used with an antibacterial filter. The device performance must
be checked prior to prescribing the SlimLine air tubing for use with an antibacterial filter.
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.

English 17
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.
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.