ResMed S9 Series User manual

AutoSet™
AutoSet™for Her
Elite™
Escape Auto™
Escape™
POSITIVE AIRWAY PRESSURE DEVICES
H5i™
H5i™for Her
HEATED HUMIDIFIER
Clinical Guide
English
Global leaders in sleep and respiratory medicine www.resmed.com
368220/5 2011-09
S9 Series
H5i
CLINICAL
AMER ENG
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.
S9: Protected by one or more patents: AU 691200, AU 697652, AU 702820, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761,
AU 764761, AU 779327, AU 2007252223, CN 200780001837.6, EP 0651971, EP 0661071, EP 0920845, EP 0927538, EP 0934723, EP 1028769, EP 1126893,
EP 1144036, EP 1502618, EP 2032857, JP 3580776, JP 3778797, JP 4647786, NZ 504595, NZ 570415, NZ 573921, NZ 577485, US 5704345, US 6138675,
US 6240921, US 6363933, US 6367474, US 6425395, US 6502572, US 6591834, US 6675797, US 6745768, US 6817361, US 6988498, US 7040317,
US 7100608, US 7537010, US 7866944. Other patents pending. Protected by design registrations: AU 329025, AU 330142, AU 331272, AU 332891,
AU 333858, CN 200830346524.1, CN 200830346526.0, CN 200830346525.6, CN 201030215797.X, EU 1067417, JP 1377401, JP 1377402, JP 1377403,
JP 1415251, JP 1415252, NZ 411762, NZ 413090, NZ 413091, US D629891, US D629892, US D635232, US D635244, US D635245, US D635654, US D638536,
US D638537, US D638933. Others pending. H5i: Protected by patents: AU 2002233025, CN ZL02804936.5, HK 1065483, JP 4420605, NZ 527088, US 6935337,
US 7614398. Other patents pending. Protected by design registrations: AU 331676, AU 331677, CN 200930203243.5, EU 1720582, JP 1402844, JP 1402845,
NZ 413752, NZ 413753, US D626642, US D627044. Other designs pending.
S9, AutoSet, S9 Elite, S9 Escape Auto, S9 Escape, H5i, SlimLine, ClimateLine and SmartStart are trademarks of ResMed Ltd. S9, AutoSet, Escape, SlimLine,
ClimateLine and SmartStart are registered in U.S. Patient and Trademark Office.
© 2011 ResMed Ltd.
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i
English
Contents
Welcome ..................................................................................................... 1
S9 AutoSet indications for use ............................................................. 1
S9 AutoSet for Her indications for use................................................. 1
S9 Elite indications for use................................................................... 1
S9 Escape Auto indications for use...................................................... 1
S9 Escape indications for use .............................................................. 1
S9 contraindications ............................................................................. 1
S9 adverse effects................................................................................ 1
H5i indications for use.......................................................................... 2
H5i for Her indications for use.............................................................. 2
H5i contraindications............................................................................ 2
S9 at a glance............................................................................................... 3
Traveling with the S9 ............................................................................ 3
H5i at a glance ............................................................................................. 4
Traveling with the H5i........................................................................... 4
Operating information .................................................................................. 5
EPR technology............................................................................................ 5
EPR checklist........................................................................................ 5
AutoSet technology...................................................................................... 6
Normal airway ...................................................................................... 6
Flow limitation...................................................................................... 6
Snore.................................................................................................... 6
Apneas ................................................................................................. 7
New to the S9 platform ............................................................................... 8
Climate Control .................................................................................... 8
Central sleep apnea.............................................................................. 9
Sleep quality......................................................................................... 9
Ramp.................................................................................................... 9
Data management.............................................................................. 10
Setup.......................................................................................................... 11
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 ......................................................................... 19
Treatment screen and clinical setup menus ....................................... 20
Delivering therapy ...................................................................................... 23
Adding supplemental oxygen ............................................................. 23
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Data management ..................................................................................... 24
SD card ...................................................................................................... 24
Removing the card ............................................................................. 24
Inserting the card ............................................................................... 24
Analyzing the SD card data ................................................................ 25
Data storage....................................................................................... 25
Data transmission adapters................................................................ 25
Cleaning and maintenance......................................................................... 26
Daily ................................................................................................... 26
Weekly .............................................................................................. 26
Monthly .............................................................................................. 26
Maintenance checklist........................................................................ 27
Replacing the air filter.........................................................................27
Antibacterial filters ............................................................................. 27
Technical specifications.............................................................................. 28
Warnings and cautions............................................................................... 32
GENERAL WARNINGS....................................................................... 32
S9 WARNINGS ................................................................................... 32
S9 CAUTIONS .................................................................................... 33
H5i WARNINGS.................................................................................. 33
AIR TUBING WARNINGS.................................................................... 33
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1
English
Welcome
Thank you for choosing the S9 Series 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 apnea (OSA) in
patients weighing more than 66 lb (>30 kg). The S9 AutoSet self-adjusting system is intended for home
and hospital use.
S9 AutoSet for Her indications for use
The S9 AutoSet for Her self-adjusting system is indicated for the treatment of obstructive sleep apnea
(OSA) in patients weighing more than 66 lb (>30 kg). The S9 AutoSet for Her 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 apnea (OSA) in patients
weighing more than 66 lb (>30 kg). The S9 Elite CPAP system is intended for home and hospital use.
S9 Escape Auto indications for use
The S9 Escape Auto self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA)
in patients weighing more than 66 lb (>30 kg). The S9 Escape Auto self-adjusting system is intended for
home and hospital use.
S9 Escape indications for use
The S9 Escape CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients
weighing more than 66 lb (>30 kg). The S9 Escape 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.
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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 for Her indications for use
The H5i for Her 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 for Her is intended for single patient re-use in
the home environment and re-use in a hospital/institutional environment.
H5i contraindications
The H5i/H5i for Her is contraindicated for use with patients whose upper (supraglottic) airway has been
bypassed.
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English
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—compatible only with the S9 AutoSet and S9 Elite
•S9 Oximeter Adapter—compatible only with the S9 AutoSet and S9 Elite
•30W power supply unit (does not support H5i)
•Power Station II battery pack
•DC/DC Converter 24V/90W.
Traveling 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 Series meets the Federal Aviation Administration (FAA) requirements
(RTCA/DO-160F, section 21, category M) for all phases of air travel.
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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 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 cleanable water tub.
Traveling with the H5i
When moving or traveling with your H5i:
•Ensure that the water tub is empty.
•Disconnect the H5i from the S9 by pressing the release button.
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English
Operating information
The following table describes the operating modes available on the S9 Series.
Mode S9
AutoSet
S9
Elite
S9 Escape
Auto
S9
Escape
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.
üüüü
AutoSet mode
The AutoSet algorithm automatically adjusts
pressure in response to inspiratory flow
limitation, snore and apnea. AutoSet mode
offers optional EPR. You can set the minimum
and maximum allowable treatment pressures.
ü–––
APAP mode
APAP mode treats apneas up to 10 cm H2O and
does not differentiate between different types
of apneas. The APAP algorithm automatically
adjusts pressure in response to inspiratory flow
limitation, snore and apnea.
– – 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 CPAP,
AutoSet or APAP modes.
EPR checklist
üYou can set EPR to Off, Ramp Only, Full Time.
üYou can select an EPR Level of Off, 1, 2, 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.
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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 analyzes 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 apnea.
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
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English
Apneas
The APAP algorithm only treats apneas up to 10 cm H2O and does not differentiate between different
types of apneas.
The enhanced AutoSet algorithm detects both obstructive and central apneas. If an apnea occurs, the
device responds appropriately.
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.
Complete airway obstruction
Time
Flow
Inspiratory flow-time curve
Absence of flow (for at least 10 sec)
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.
Open unrestricted airway
Time
Flow
Inspiratory flow-time curve
Absence of flow (for at least 10 sec)
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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)
60ºF (16ºC) 10 mg/L
68ºF (20ºC) 12 mg/L
75ºF (24ºC) 16 mg/L
80ºF (27ºC) 19 mg/L
86ºF (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 or APAP algorithms
•flow due to mask or mouth leak.
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English
Central sleep apnea
The S9 AutoSet and S9 Elite detect 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 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.
Note: The S9 Escape and S9 Escape Auto do not differentiate between different types of apneas.
Respiratory flow
delay
(respiratory
pause)
CSA detector
begins
Apnea type
detected -
Central or
Obstructive
4 sec 6 sec
10 sec
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.
Ramp
Designed to make the beginning of treatment more comfortable, ramp is available in CPAP, AutoSet or
APAP modes.
In CPAP mode during ramp time, the pressure increases from a low pressure to the prescribed
treatment pressure.
In AutoSet and APAP modes, 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 previous products in the AutoSet range, settling was the period
where the device was at a minimum treatment pressure until the auto-adjusting algorithm commenced.
Pressure
20
16
8
4
0Time
Max
Min
Settling
Ramp
Start
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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 the S9 AutoSet and S9 Elite. The
amount of data stored on the SD card varies compared to the data stored on the device.
Note: The S9 Escape and S9 Escape Auto only provide compliance and therapy summary and statistic
data.
Type of data S9 device SD Card
Compliance and therapy summary and statistic data1365 nights 365 nights
Detailed data2– 30 nights
High resolution flow data2– 7 nights
1The pressure and leak samples used to calculate the statistics data are averages over a one minute period.
2Only available in the S9 AutoSet and S9 Elite.
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English
3
1
2
4
5
6
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.
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:
6’ (1.8 m)
0.6” (15 mm)
Default setting
Standard
Length:
Inner diameter:
6’6” (2 m)
0.75” (19 mm)
If using the standard tubing, adjust the tube
setting in the Patient Setup or Clinical Setup
menus.
ClimateLine
Length:
Inner diameter:
Heated
6’6” (2 m)
0.6” (15 mm)
Automatically detected
ClimateLineMAX
Length:
Inner diameter:
Heated
6’3” (1.9 m)
0.75” (19 mm)
Automatically detected
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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 center hole) with distilled or deionized water
up to the maximum water level mark (12.5 fl oz / 380 mL).
4. Return the water tub to the H5i.
5. Close the flip lid ensuring that it clicks into place.
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English
Info menu
Allows you to
view your sleep
statistics.
LCD screen
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.
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)
Backlight
When treatment is being
delivered, the backlight
(including the Start/Stop
button) automatically
turns off after 30 seconds,
otherwise it turns off
after 3 minutes.
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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.
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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 treatment pressure or minimum treatment
pressure.
Ramp is available in AutoSet, CPAP and APAP 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
Available in the S9 AutoSet and S9 Elite, 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 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 .
Note: Mask-fit is not available in the S9 Escape or S9 Escape Auto.
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Treatment screens
Depending on how the system has been configured, you will see one of the following screens when the
device is running:
üH5i humidifier üH5i humidifier
üClimateLine or
ClimateLineMAX heated air
tube
üClimate Control – Auto
üH5i humidifier
üClimateLine or
ClimateLineMAX heated air
tube
üClimate Control – Manual
üStandard S9 without optional
accessories
üOximetry data via the oximeter adapter (the oximeter adapter is
compatible only with the S9 AutoSet and S9 Elite)
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.
Mask-fit indicates ‘Good’ if the 70th percentile leak is less than 24 L/min.
Note: Mask-fit and AHI data are only available in the S9 AutoSet and S9 Elite.
For Sleep Report, only the period can be changed—other values are for display only.
Sleep Quality = On Sleep Quality = Usage
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