ResMed S9 Elite User manual

AutoSet™& Elite™
POSITIVE AIRWAY PRESSURE DEVICES
H5i™
HEATED HUMIDIFIER
Clinical Guide
English
Global leaders in sleep and respiratory medicine www.resmed.com
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001
Spectrum Center Boulevard San Diego CA 92123 USA. ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK.
See www.resmed.com for other ResMed locations worldwide.
For patent information, see www.resmed.com/ip.
S9, AutoSet, S9 Elite, H5i, SlimLine, ClimateLine, SmartStart are trademarks of ResMed Ltd. S9, H5i, AutoSet, SlimLine, ClimateLine
and SmartStart are registered in U.S. Patent and Trademark Office.
© 2012 ResMed Ltd.
368134/7 2012-10
S9 Series
AutoSet & Elite
H5i
CLINICAL
ROW ENG

i
English
Contents
Welcome ..................................................................................................... 1
S9 AutoSet indications for use ............................................................. 1
S9 Elite indications for use ................................................................... 1
S9 contraindications ............................................................................. 1
S9 adverse effects................................................................................ 1
H5i indications for use.......................................................................... 1
H5i contraindications............................................................................ 1
S9 at a glance............................................................................................... 2
Travelling with the S9 ........................................................................... 2
H5i at a glance ............................................................................................. 3
Travelling with the H5i .......................................................................... 3
Operating information .................................................................................. 4
EPR technology............................................................................................ 4
EPR checklist........................................................................................ 4
AutoSet technology...................................................................................... 5
Normal airway ...................................................................................... 5
Flow limitation...................................................................................... 5
Snore.................................................................................................... 5
Apnoea ................................................................................................. 6
New to the S9 platform ............................................................................... 7
Climate Control .................................................................................... 7
Central sleep apnoea............................................................................ 8
S9 Essentials........................................................................................ 8
Sleep quality......................................................................................... 8
Ramp.................................................................................................... 9
Data management................................................................................ 9
Setup.......................................................................................................... 10
Mask and tubing setup....................................................................... 11
Filling the water tub ................................................................................... 12
S9 basics.................................................................................................... 13
Navigating the menus ................................................................................ 14
About the menus ....................................................................................... 14
Home menu ...................................................................................... 14
Changing settings via the Home menu .............................................. 15
Treatment screens ............................................................................. 16
Info menu........................................................................................... 16
Setup menu........................................................................................ 17
Reminder menu.................................................................................. 18
Managing Climate Control ......................................................................... 18
Treatment screen and clinical setup menus ....................................... 19
Delivering therapy ...................................................................................... 22
Adding supplemental oxygen ............................................................. 22
Data management ..................................................................................... 23
SD card ...................................................................................................... 23
Removing the card ............................................................................. 23

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Inserting the card ............................................................................... 23
Analysing the SD card data ................................................................ 24
Data storage....................................................................................... 24
Data transmission adapters................................................................ 24
Cleaning and maintenance......................................................................... 25
Disassembling the H5i ....................................................................... 25
Daily ................................................................................................... 25
Monthly .............................................................................................. 25
Reassembling the H5i ........................................................................ 26
Maintenance checklist........................................................................ 26
Reprocessing the H5i between patients............................................ 26
Replacing the air filter......................................................................... 27
Antibacterial filters ............................................................................. 27
Technical specifications.............................................................................. 28
WARNINGS ........................................................................................ 32
CAUTIONS.......................................................................................... 32

1
English
Welcome
Thank you for choosing the S9 AutoSet, S9 Elite or H5i.
Before operating these devices, please read the entire Clinical and Information Guides.
S9 AutoSet indications for use
The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnoea (OSA)
in patients weighing more than 30 kg. The S9 AutoSet self-adjusting system is intended for home and
hospital use.
S9 Elite indications for use
The S9 Elite CPAP system is indicated for the treatment of obstructive sleep apnoea (OSA) in patients
weighing more than 30 kg. The S9 Elite CPAP system is intended for home and hospital use.
S9 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.
S9 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 these devices:
• drying of the nose, mouth, or throat
• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes.
H5i indications for use
The H5i is indicated for the humidification of the air delivered from a CPAP or bilevel device. The H5i is
for use only as recommended by a physician. The H5i is intended for single patient re-use in the home
environment and re-use in a hospital/institutional environment.
H5i contraindications
The H5i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed.

2
Air filterDC power inlet
SD card slot
Module/Adapter port
Air outlet
S9 at a glance
The S9 system comprises the following elements:
• S9 device
• SlimLine air tubing
• 90W power supply unit
• S9 travel bag
• SD card
• S9 SD card protective folder.
Optional components include:
• H5i heated humidifier
• Standard air tubing
• S9 Wireless Module
• S9 Oximeter Adapter
• 30W power supply unit (does not support H5i)
• Power Station II battery pack
• DC/DC Converter 24V/90W.
Travelling with the S9
When the patient travels with the S9 only:
• Advise the patient to pack the SlimLine or Standard air tubing as the ClimateLine or ClimateLineMAX
heated air tubing is not designed to connect directly to the S9 device.
• Advise the patient to purchase and travel with the approved power cord for the region where they will
be using the S9 device.
• ResMed confirms that the S9 AutoSet and S9 Elite meets the Federal Aviation Administration (FAA)
requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.

3
English
Latch
Release
button
ClimateLine /
ClimateLineMAX
connection
port
Air outlet
Flip lid
Flip lid seal
H5i
water tub
H5i at a glance
The H5i system comprises the following elements:
• H5i heated humidifier
• H5i cleanable water tub
• ClimateLine heated air tubing (if sold as a Climate Control Kit).
Optional components include:
• ClimateLine heated air tubing
• ClimateLineMAX heated air tubing
• H5i standard water tub.
Travelling with the H5i
When moving or travelling with your H5i:
• Ensure that the water tub is empty.
• Disconnect the H5i from the S9 by pressing the release button.

4
Operating information
The following table describes the operating modes available on the S9 AutoSet and S9 Elite.
Mode S9 Elite S9 AutoSet
CPAP mode
A fixed pressure is delivered with optional Expiratory Pressure
Relief (EPR). EPR can help ease any discomfort that your
patient experiences when breathing out during treatment.
ü ü
AutoSet mode
The AutoSet algorithm automatically adjusts pressure in
response to inspiratory flow limitation, snore and apnoea.
AutoSet mode offers optional EPR. You can set the minimum
and maximum allowable treatment pressures.
–ü
EPR technology
Designed to make therapy more comfortable, EPR maintains optimal treatment for the patient during
inhalation and reduces the delivered mask pressure during exhalation. You can select EPR in either CPAP
or AutoSet mode.
EPR checklist
üYou can set EPR to Off, Ramp Only, Full Time.
üYou can select an EPR Level of Off, 1, 2, or 3 cm H2O, or Patient (configurable by the patient).
üIn CPAP mode you can set the EPR Inhale to Med or Fast.
üWhen EPR is enabled, the delivered pressure will not drop below a minimum pressure of 4 cmH2O,
regardless of the settings.

5
English
AutoSet technology
The treatment pressure required by your 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 analyses the state of your 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 apnoea.
Normal airway
When your patient is breathing normally, the inspiratory flow measured by the device as a function of
time shows a typically rounded curve for each breath.
Open unrestricted airway
Time
Flow
Inspiration
Unrestricted inspiratory flow-time curve (rounded)
Flow limitation
As the upper airway begins to collapse, the shape of the inspiratory flow-time curve changes. The S9
recognises and treats traditional as well as less common flow-limited breath wave forms.
10
Silent partial airway obstruction
Time
Flow
Flattened inspiratory flow-time curve
(denoting partial obstruction)
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.
22 ©ResMed 08 2007
Noisy partial airway obstruction
Time
Flow
Snore superimposed on inspiratory flow-time curve

6
Apnoea
The enhanced AutoSet algorithm detects both obstructive and central apnoeas. If an apnoea occurs, the
device responds appropriately.
Obstructive apnoea
An obstructive apnoea is when the upper airway becomes severely limited or completely obstructed.
AutoSet generally prevents obstructive apnoeas from occurring by responding to flow limitation and
snoring. If an obstructive apnoea occurs, the device will respond by increasing pressure.
Complete airway obstruction
Time
Flow
Inspiratory flow-time curve
Absence of flow (for at least 10 sec)
Central apnoea
During a central apnoea, the airway will remain open, but there is no flow. When a central apnoea is
detected, the device responds appropriately by not increasing pressure.
Open unrestricted airway
Time
Flow
Inspiratory flow-time curve
Absence of flow (for at least 10 sec)

7
English
New to the S9 platform
Climate Control
S9 devices, when used in conjunction with the H5i and ClimateLine or ClimateLineMAX heated air tubing,
offer a feature called Climate Control.
Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient’s
upper airway while protecting against rainout and allowing patients to select the air temperature that
offers the most comfort for them.
Rainout protection
Rainout refers to the water or condensation that collects in the patient’s tubing or mask. Rainout is a
common side effect of using a humidifier due to the humidified air cooling as it travels down the tubing
and into the mask. Rainout occurs when relative humidity, which is a measure of the air’s capacity to hold
water vapour, exceeds 100%.
Climate Control protects the patient from rainout by maintaining a target relative humidity of 80% as well
as maintaining the temperature of the air delivered to the patient without compromising the amount of
absolute humidity delivered.
Automatic constant humidity delivery
For each temperature setting, the Climate Control system delivers a constant amount of water vapour, or
absolute humidity, to the patient’s upper airway. The following table shows the target absolute humidity
value that will be delivered to the mask for a selection of temperature settings.
Temperature delivered to the mask Target absolute humidity at the mask,
Body Temperature Pressure Saturated (BTPS)
16ºC 10 mg/L
20ºC 12 mg/L
24ºC 16 mg/L
27ºC 19 mg/L
30ºC 22 mg/L
Automatic constant temperature delivery
The temperature sensor located at the mask end of the ClimateLine or ClimateLineMAX heated air
tube 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.
Automatic adjustment
The H5i and ClimateLine or ClimateLineMAX heated 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 from the AutoSet algorithm or mask or mouth leak.

8
Central sleep apnoea
The S9 Series detects both obstructive and central sleep apnoeas (CSA). CSA detection uses the Forced
Oscillation Technique (FOT) to determine the state of the patient’s airway during an apnoea. When an
apnoea has been detected, small oscillations in pressure (1 cm H2O peak-to-peak at 4 Hz) are added to
the current device pressure. The CSA algorithm uses the resulting flow and pressure (determined at the
mask) to measure the airway patency.
Respiratory flow
delay
(respiratory
pause)
CSA detector
begins
Apnea type
detected -
Central or
Obstructive
4 sec 6 sec
10 sec
S9 Essentials
S9 Essentials is designed to make device interaction and menu navigation easier for patients. If enabled,
S9 Essentials disables the Info and Setup functionality so that patients can simply start and stop therapy
and adjust ramp, humidification and Climate Control. S9 Essentials can be enabled via Clinical Setup >
Options > Access.
Sleep quality
Designed to promote compliance, the Sleep Quality indicator allows the patient to actively engage in
their own therapy by identifying leak, usage and AHI information. This information can be set to:
• Usage—where only usage hours are displayed
• On—where usage, leak and AHI information are displayed.

9
English
Ramp
Designed to make the beginning of treatment more comfortable, ramp is available in both CPAP and
AutoSet modes.
Ramp time defines the period during which the pressure gradually increases from a lower more
comfortable start pressure to the minimum AutoSet pressure before the auto-adjusting algorithm
commences. In previous products in the AutoSet range, settling was the period where the device was at
a minimum AutoSet pressure until the auto-adjusting algorithm commenced.
Pressure
20
16
8
4
0
Time
AutoSet Max
AutoSet Min
Settling
Ramp
Start
Data management
Designed to make data more easily available, the S9 SD card gives clinicians greater insight to patient
therapy by making high resolution flow and detailed data available on every device. The amount of data
stored on the SD card varies compared to the data stored on the device.
Type of data S9 device SD Card
Compliance and therapy summary and statistic data
(usage, AHI, pressure, and leak)
365 nights 365 nights
Detailed data – 30 nights
High resolution flow data – 7 nights

10
Setup
1. Align your H5i with your S9 and push them together until they click into place.
2. Connect the DC plug of the power supply unit to the rear of the S9.
3. Connect the power cord to the power supply unit.
4. Plug the other end of the power cord into the power outlet.
5. Connect one end of the air tubing firmly onto the air outlet.
6. Connect the assembled mask system to the free end of air tubing.
Notes:
•Always ensure that the S9 and H5i are placed on a stable, level surface for proper operation.
•Place the power supply unit away from the H5i to allow for adequate ventilation.

11
English
Mask and tubing setup
• For more information on assembling the mask see the mask user guide.
• If your patient is using a full face mask ensure that the “Full Face” setting is selected. If your patient
is using a nasal pillows mask ensure that the “Pillows” setting is selected. If your patient is using a
nasal mask ensure that the “Nasal” setting is selected with the exception of the Ultra Mirage mask
which should use the “Nasal Ultra” setting.
• For a complete list of recommended masks and their settings go to www.resmed.com on the
Products page under Service & Support. If you do not have internet access, please contact your
ResMed representative.
• The S9 device is compatible with the following tubing:
Tube Specifications Settings
SlimLine
Length:
Inner diameter:
1.8 m
15 mm
Default setting
Standard
Length:
Inner diameter:
2 m
19 mm
If using the standard tubing, adjust the tube setting in
the Patient Setup or Clinical Setup menus.
ClimateLine
Length:
Inner diameter:
Heated
2 m
15 mm
Automatically detected
ClimateLineMAX
Length:
Inner diameter:
Heated
1.9 m
19 mm
Automatically detected

12
Filling the water tub
1. Slide the latch and lift open the flip lid.
2. Remove the water tub.
3. Fill the water tub (through the centre hole) with water
up to the maximum water level mark (380 mL).
4. Return the water tub to the H5i.
5. Close the flip lid ensuring that it clicks into place.

13
English
LCD screen
Start/Stop button
Starts or stops
treatment.
S9 basics
Home menu
Key
Home
Ramp
Start/Stop
Power Save mode (hold for 3 sec)
Push Dial
Setup menu
Info menu
Advanced Info menu (hold for 3 sec)
Clinical Setup menu (hold for 3 sec)
Info menu*
Allows you to
view your sleep
statistics.
Setup menu*
Allows you to
make changes
to settings.
Push Dial
Turning the dial
allows you to
scroll through the
menu and change
settings. Pushing the
dial allows you to
enter into a menu and
confirm your choice.
Backlight
When treatment is being
delivered, the backlight
(including Start/Stop
button) automatically
turns off after 30
seconds, otherwise it
turns off after 3 minutes.
* The Info and Setup menus are disabled if S9 Essentials is enabled.

14
Navigating the menus
In general, to navigate the menus:
1. Turn until the
parameter you
require is displayed
in blue.
2. Press .
The selection is
highlighted in
orange.
3. Turn until you
see the setting that
you require.
4. Press to confirm
your choice. The
screen returns to
blue.
About the menus
There are three menus that are designed to help you to navigate to where you want to go. They are:
1. Home menu—for day to day adjustments.
2. Info menu—provides sleep quality information.
3. Setup menu—where settings can be adjusted.
Home menu
The Home menu shows you and your patient what features are currently activated, and the accessories
that are connected to the device.
Ramp—displayed when the Max Ramp function is activated in the
Clinical Setup menu.
Humidity Level—displayed when the H5i is connected.
Climate Control—displayed when both the H5i and the
ClimateLine or ClimateLineMAX heated air tube are connected and
when Climate Control is activated in the Clinical Setup menu.
Humidity Level and Heated Tube—displayed when both the
H5i and the ClimateLine or ClimateLineMAX heated air tube are
connected and when Climate Control is set to Manual in the Clinical
Setup menu.

15
English
Changing settings via the Home menu
From the home menu, you can adjust or check the following features:
Ramp
Designed to make the beginning of treatment more comfortable for the
patient, ramp time is the period during which the pressure increases from
an initial pressure to the prescribed CPAP pressure or minimum AutoSet
pressure.
Ramp is available in both AutoSet and CPAP modes.
Humidity level
The patient can adjust their humidity level at any time to find the setting that
is most comfortable for them.
Climate Control
When the ClimateLine or ClimateLineMAX heated air tubing is connected and
Climate Control is enabled, the patient can adjust the air temperature to find
the setting that is most comfortable for them.
When set to Auto, Climate Control prevents rainout by maintaining 80%
relative humidity in the delivered air. If Climate Control is set to Manual,
Humidity Level and Heated Tube temperature can be set independently.
Mask-fit
Mask-fit is designed to help patients fit the mask properly.
In the S9 AutoSet, the mask-fit pressure is based on the 95th percentile of
the previous session or 10 cm H2O whichever is greater.
In the S9 Elite, the mask-fit feature delivers 10cmH2O or set CPAP pressure
(whichever is greater) for a three-minute period, prior to starting treatment.
During this time, the mask can be adjusted to minimize leaks.
To use mask-fit:
1. Fit the mask as described in the mask user guide.
2. Press for at least three seconds.
One of the MASK FIT screens shown is displayed (as shown on the left).
3. If necessary, adjust the mask, mask cushion and headgear until there is
a secure and comfortable fit. After three minutes, the pressure reverts
to the set pressure and treatment will begin. You can end mask-fit at any
time by pressing .
S9 Essentials
When S9 Essentials is enabled, the patient can simply start and stop therapy, access mask-fit and adjust
ramp, humidification and Climate Control.

16
Treatment screens
Depending on how the system has been configured, you will see one of the following screens when the
device is running:
üStandard S9 without optional
accessories
üOximetry data via oximeter
adapter
üH5i humidifier üH5i humidifier
üClimateLine or
ClimateLineMAX heated air
tube
üClimate Control – Auto
üH5i humidifier
üClimateLine or
ClimateLineMAX heated air
tube
üClimate Control – Manual
Info menu
Designed to provide you with information about compliance, therapy and settings, the Info menu consists
of: Standard Info menu; and Advanced Info menu.
Standard Info menu
From the Standard Info menu, patients can check their sleep quality, sleep report and service information.
When Sleep Quality is set to On (via Setup > Clinical Setup > Options), data on previous usage (up to 365
days of data), mask fit, and AHI can be viewed. For Sleep Report, only the period can be changed—other
values are for display only.
Sleep Quality = On Sleep Quality = Usage
Mask-fit indicates ‘Good’ if the 70th percentile leak is less than 24 L/min.
+Advanced Info menu (Hold for 3 sec)
To access the Advanced Info menu, press and hold the Info and Setup buttons for three seconds. This
provides patients with additional therapy settings and compliance information.
This screen provides the same options as shown on the Clinical Info menu on the following page.