S9 VPAP™ Tx
POSITIVE AIRWAY PRESSURE THERAPY DEVICE
Clinical Guide
English
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S9 VPAP™ Tx
POSITIVE AIRWAY PRESSURE THERAPY DEVICE
Clinical Guide
English
Download from Www.Somanuals.com. All Manuals Search And Download.
Contents
Delivering therapy.................................................................................21
Troubleshooting.....................................................................................25
Limited warranty...................................................................................31
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General warnings and cautions
WARNINGS
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Read the entire manual before using the device.
Use the device only as directed by the physician or healthcare provider.
Use the device only for the intended use as described in this manual. Advice contained in this
manual should not supersede instructions given by the physician.
•
If you notice any unexplained changes in the performance of the device, if it is making unusual
or harsh sounds, if the device or the power supply are dropped or mishandled, if water is
spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your
ResMed Service Center.
The device should only be used with masks (and connectors) recommended by ResMed or by
a physician or respiratory therapist. A mask should not be used unless the device is turned on.
Once the mask is fitted, ensure that the device is blowing air.The vent hole or holes associated
with the mask should never be blocked.
•
Explanation:The device is intended to be used with special masks (or connectors) which have
vent holes to allow continuous flow of air out of the mask. When the device is turned on and
functioning properly, new air from the device flushes the exhaled air out through the mask
vent holes. However, when the device is not operating, insufficient fresh air will be provided
through the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for
longer than several minutes can, in some circumstances, lead to suffocation.This applies to
most models of CPAP or bilevel devices
Only ResMed air tubing and accessories should be used with the device. A different type of air
tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of
the treatment.
Only use the ResMed 90W or 30W power supply unit. Use the 90W power supply unit to power
the system comprising the device, H5i, air tubing, DC/DC converter and battery pack.The 30W
power supply unit is designed to power the device only and recommended for traveling.
To maintain electrical safety and in accordance with IEC 60601, where a personal computer is
used with the flow generator, the personal computer must be at least 5’ (1.5 m) away from, or
at least 8’ (2.5 m) above the patient.The Personal Computer must comply to IEC 60950.
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CAUTIONS
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In the US, Federal law restricts the device to sale by or on order of a physician.
Ensure that the device is protected against water. Enclose the device in the S9 travel bag for
transport.
Note: The above are general warnings and cautions. Specific warnings, cautions and notes appear with
the relevant instructions in the manual.
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Welcome
The S9 VPAPTx provides continuous positive airway pressure (CPAP) and bilevel therapy.
The S9 VPAPTx is a component of the S9 VPAPTx Lab System. The S9 VPAPTx Lab System provides
remote PC control of a positive airway pressure therapy device (therapy device) capable of delivering
multiple therapy modes. The system comprises:
1. S9 VPAPTx or other compatible ResMed therapy device
2. Tx Link connection module
3. EasyCareTx titration software.
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This guide provides instructions for the S9 VPAPTx. Refer to theTx Link Quick Setup Guide and EasyCare
Tx Online Help for instructions on their use.
S9VPAPTx indications for use
The S9 VPAPTx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA),
respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes
are indicated for patients weighing more than 30 lb (13 kg); all other modes are indicated for patients
weighing more than 66 lb (30 kg).
The S9 VPAPTx is intended to be used in a clinical environment.
S9VPAPTx contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing
conditions:
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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.
S9VPAPTx adverse effects
Patients should report unusual chest pain, severe headache or increased breathlessness to the clinician.
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:
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drying of the nose, mouth or throat
nosebleed
bloating
ear or sinus discomfort
eye irritation
skin rashes.
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S9VPAPTx at a glance
Module/Adapter port
Air filter
DC power inlet
Air outlet
The S9 VPAPTx system comprises the following elements:
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S9 VPAPTx device
H5i heated humidifier
ClimateLine™ heated air tubing
90W power supply unit
S9 travel bag
S9 USB Adapter.
Optional components include:
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Standard air tubing
SlimLine™ air tubing
ClimateLineMAX ™ heated air tubing
3 m air tubing
Antibacterial filter.
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Masks
information on using a mask refer to the mask user guide.
page under Service & Support. If you do not have internet access, please contact your ResMed
representative.
CAUTION
Non-vented masks should not be used with the device.
Supplemental oxygen
Supplemental oxygen can be used with the S9 VPAPTx. For more information, see “Adding supplemental
oxygen” on page 22.
Antibacterial filters
Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and
delivered pressure, particularly at high flows. ResMed has tested and recommends using an antibacterial
filter with a low impedance (eg, 2 cm H2O at 60 L/min).
Humidifier
The S9 VPAPTx is compatible with the H5i heated humidifier. For further information on using this
humidifier refer to the H5i user guide.
USB Adapter
The S9 USB Adapter is designed for use with the S9 VPAPTx. The USB adapter connects the S9 VPAP Tx
to a personal computer viaTx Link for remote monitoring and control. For further information on using
this adapter refer to the S9 USB Adapter user guide.
Climate Control
The S9 VPAPTx, when used in conjunction with the H5i and ClimateLine or ClimateLineMAX heated air
tubing, offers 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.
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Therapy modes
The following table describes the therapy modes available on the S9 VPAPTx.
Therapy mode
Description
CPAP (Continuous Positive Airway
Pressure)
Delivers a fixed pressure with optional Expiratory
Pressure Relief (EPR). EPR can improve patient comfort.
AutoSet
Delivers CPAP therapy with optional Expiratory Pressure
Relief (EPR). Automatically adjusts the CPAP pressure in
response to snore, flow limited breaths and apneas.
VAuto
Automatically adjusts pressure in response to flow
limitation, snore and apneas. Pressure Support (PS) is
fixed throughout the night and can be set by the clinician.
Min EPAP and Max IPAP restrict the delivered pressure
range.
Bilevel
Provides for control over a number of related bilevel
therapy modes—S, S/T andT. In all cases you may set
two treatment pressures— one for inspiration (IPAP) and
one for expiration (EPAP). The difference between IPAP
and EPAP levels is the pressure support.
S (Spontaneous)
Senses when the patient is inhaling and exhaling
and supplies the appropriate pressures accordingly.
The difference between IPAP and EPAP levels helps
determine the tidal volume.
S/T (Spontaneous/Timed)
T (Timed)
Augments any breath initiated by the patient, but will also
supply additional breaths should the patient breath rate
fall below the clinician's set backup respiratory rate.
The fixed respiratory rate and the fixed inspiration/
expiration time set by the clinician is supplied regardless
of patient effort.
PAC (Pressure Assist Control)
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 backup breath rate.
ASV (Adaptive Servo-ventilation)
Treats central sleep apnea and/or mixed apneas and
periodic breathing. In ASV mode, the expiratory positive
airway pressure (EPAP) is adjusted by the clinician to
maintain upper airway patency, while Min PS and Max
PS restricts the range of automatically adjusted pressure
support.
ASVAuto (Automatic Adaptive
Servo-ventilation)
Treats central sleep apnea and/or mixed apneas and
periodic breathing. In ASVAuto mode, the expiratory
airway pressure (EPAP) is automatically adjusted to
maintain upper airway patency between the limits set
by Min EPAP and Max EPAP, while Min PS and Max PS
restrict the range of automatically adjusted pressure
support.
iVAPS (intelligent Volume-Assured
Pressure Support)
Maintains a preset target alveolar minute ventilation by
monitoring delivered ventilation, adjusting the pressure
support and providing an intelligent backup breath
automatically.
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S9VPAPTx basics
Info menu button
LCD screen
Start/Stop
button
Alarm and
therapy LEDs
Setup menu button
Alarm mute
button
Push dial
Key
Function
Starts or stops treatment.
Start/Stop button
Power Save mode—hold for three seconds.
Allows you to view the device service information or to exit from
the menu.
Info menu button
Setup menu button
Push dial
Allows you to make changes to settings or to exit from the menu.
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.
Press once to mute alarms. Press a second time to un-mute. If
the problem is still present, the alarm will sound again after two
minutes.
Alarm mute button
LCD screen
Displays the menus, treatment screens and reminders.
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.
Alarm LED
Yellow LED—flashes during an alarm.
Blue LED—always on during therapy (if enabled in the Options
menu).
Therapy LED
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Setting up the S9VPAPTx
Module/Adaptor Port
4
To Tx Link
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6
8
1
3
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2
WARNING
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Make sure the power cord and plug are in good condition and the equipment is not damaged.
Keep the power cord away from hot surfaces.
Do not leave long lengths of air tubing around the top of the patient’s bed. It could twist around
the patient’s head or neck while they are sleeping.
Do not use electrically conductive or antistatic air tubings.
Do not use the air tubing if there are any visible signs of damage.
Only ResMed products are designed to be connected to the module connector port. Connecting
other devices could damage the device.
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CAUTION
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Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is
correctly set up.
Be careful not to place the device where it can be bumped or where someone is likely to trip
over the power cord.
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The H5i should only be connected or disconnected when the water tub is empty.
Always place the H5i on a level surface below the level of the user to prevent the mask and
tubing from filling with water.
The S9 VPAPTx is compatible with the integrated H5i heated humidifier. For further information on using
this humidifier refer to the H5i user guide.
1. Align the H5i with the S9 VPAPTx 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 VPAPTx.
3. Connect the power cord to the power supply unit.
4. Plug the USB Module into the Module/Adaptor port at the rear of the S9 VPAPTx.
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5. Connect the S9 VPAPTx to theTx Link via USB serial cable.
6. Plug the other end of the power cord into the power outlet.
7. Connect one end of the air tubing firmly onto the air outlet.
8. Connect the assembled mask system to the free end of air tubing.
The S9 VPAPTx does not use the SD Card function to store data. All necessary data is transferred viaTx
Link and available through the EasyCareTx software.
Notes:
•
Always ensure that the S9 VPAPTx is placed in an area where the alarm LED indicators are clearly
visible.
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Place the power supply unit away from the H5i to allow for adequate ventilation.
Filling the water tub
WARNING
Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in
water. In the event of a spill, disconnect the device from the power supply and let the parts dry.
Always unplug the device before cleaning and make sure that all parts are dry before plugging in
the device.
CAUTION
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•
Do not overfill the water tub as water may enter the device and air tubing.
Do not use any additives (eg, scented oils and perfumes).These may reduce the humidification
output of the H5i and/or cause deterioration of the water tub materials.
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Take care when handling the H5i as the water/water tub may be hot. Allow 10 minutes for the
heater plate and any excess water to cool.
If liquids are inadvertently spilled into or on the H5i, unplug the device from the power outlet.
Disconnect the H5i from the device and allow it to drain and dry before re-using.
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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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Mask and air tubing settings
Use the following settings below for each mask type:
Mask type
Full Face
Pillows
Settings
Full Face
Pillows
Nasal
Nasal (for Ultra Mirage mask, use ‘Nasal Ultra’)
Pediatric
Pediatric
Notes:
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•
For more information on assembling the mask see the mask user guide.
Products page under Service & Support. If you do not have internet access, please contact your
ResMed representative.
The S9 VPAPTx is compatible with the following air tubing:
Air tubing
Specifications
Settings
ClimateLine
Heated
Automatically detected
Length: 6’6” (2 m)
Inner diameter: 0.6” (15 mm)
ClimateLineMAX
Heated
Automatically detected
Length: 6’3” (1.9 m)
Inner diameter: 0.75” (19 mm)
SlimLine
Standard
Length: 6’ (1.8 m)
If using the SlimLine, Standard or 3 m
air tubing, adjust the tube setting via the
Setup menu.
Inner diameter: 0.6” (15 mm)
Length: 6’6” (2 m)
Inner diameter: 0.75” (19 mm)
3 m
Length: 9’10” (3 m)
Inner diameter: 0.75” (19 mm)
Notes:
•
When using the SlimLine or ClimateLine above 20 cm H2O, the device optimum performance may
not be reached if used with an antibacterial filter. The device performance must be checked prior to
using the SlimLine for use with an antibacterial filter.
•
The ClimateLine/ClimateLineMAX are designed only for use with the H5i.
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Navigating the menus
In general, to navigate the menus:
1. Turn
until the
2. Press
.
3. Turn
until you
4. Press
to confirm
parameter you
The selection is
highlighted in
orange.
see the setting that
you require.
your choice. The
require is displayed
in blue.
screen returns to
blue.
About the menus
There are three menus that are designed to help you choose your options. These are:
1. Home menu—for day to day adjustments.
2. Setup menu—where settings can be adjusted.
3. Info menu—provides service information.
Home menu
The Home menu shows you what features are currently activated, and the accessories that are
connected to the device.
Humidity Level—displayed when the H5i is connected.
Climate Control—displayed when both the H5i and the
ClimateLine or ClimateLineMAX heated air tubing are connected and
when Climate Control is set to Auto in the Setup menu.
Humidity Level and HeatedTube—displayed when both the
H5i and the ClimateLine or ClimateLineMAX heated air tubing are
connected and when Climate Control is set to Manual in the Setup
menu.
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Changing settings via the Home menu
From the Home menu, you can adjust or check the following features:
Humidity level
Humidity levels can be adjusted at any time to find the setting that is most
comfortable for the patient.
Climate Control
When the ClimateLine or ClimateLineMAX heated air tubing is connected and
Climate Control is enabled, the air temperature can be adjusted to find the
setting that is most comfortable for the patient.
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 HeatedTube temperature can be set independently.
Mask Fit
Mask Fit is designed to help fit the mask properly to the patient.
The Mask Fit feature delivers CPAP pressure for a three-minute period,
prior to starting treatment. During this time, the mask can be adjusted to
minimise 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
.
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Viewing the treatment screens
Depending on how the system has been configured and what mode has been selected, you will see one
of the following example screens (shown in iVAPS mode below) when the device is running:
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H5i humidifier
9
9
9
H5i humidifier
ClimateLine/ClimateLineMAX 9 ClimateLine/ClimateLineMAX
Climate Control – Auto Climate Control – Manual
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H5i humidifier
9
9
Therapy data
To toggle between the treatment screens, press
from your HOME screen.
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Treatment with device
trigger (Timed) and cycle
(Timed, Ti Max orTi Min)
breath indicators
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Treatment with spontaneous
trigger and cycled breaths
Pressure bar: In bilevel modes, the pressure bar is marked with fixed vertical lines indicating the
expiratory and inspiratory pressures. In CPAP and AutoSet modes, only a set pressure is shown.
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Treatment screen parameters
Parameter
Modes
Description
Leak
Estimate of the total rate of
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air escaping due to mouth and
unintentional mask leaks, expressed in
L/min (5-breath moving average).
Minute Ventilation (MV)
Volume of air breathed in, or out within
any 60-second period, expressed in
L/min (5-breath moving average).
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Target Minute
Ventilation (TgMv)
Minute ventilation the device is
attempting to achieve. Pressure support
increases if the minute ventilation falls
below the target,and decreases if it
goes above the target.
9 9
Respiratory rate (RR)
Tidal volume (Vt)
Frequency of breathing, expressed
as the number of breaths per minute
(5-breath moving average).
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Volume of air inspired or expired in one
respiratory cycle (breath), expressed in
mL (5-breath moving average).
Pressure support (PS)
Difference between IPAP and EPAP.
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Alveolar minute
ventilation (Va)
Minute volume without dead space,
expressed in L/min.
Target alveloar
Target alveolar minute ventilation that
determines the amount of pressure
support required, expressed in
L/min.
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9 9 9 9 9 9 9 9
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ventilation (TgVa)
Ti
Duration of inspiration (ie, the
respiratory flow into the lungs),
expressed in seconds (5-breath moving
average).
I:E
Inspiration to expiration ratio measured
by the device (5-breath moving
average).
Ti Max
Ti Min
Maximum inspiration time in seconds
Minimum inspiration time in seconds.
9 9 9
9 9 9
9
9
% Spontaneous
Triggering or Cycling
(%SpontTrig or
%Spont Cyc)
Percentage of breaths that are
spontaneously triggered or cycled
(average of the last 20 breaths).
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In PAC mode, there is no spontaneous
cycling.
Trigger/Cycle indicators
(Timed, Ti Max or
Ti Min)
Indicates a patient or device
triggered/cycled breath. In ST mode,
Timed indicator is left blank if it is a
spontaneous breath.
9 9 9 9 9 9
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Setup menu
The Setup menu allows set up of all parameters pertaining to the patient’s therapy.
Setup menu access
To access Setup menu, press the Setup button. There are three screens available from the Setup menu
as shown in iVAPS mode below:
Settings
Displays parameters directly affecting the patient’s therapy.
Options
Displays parameters affecting the patient’s comfort.
Configuration
Displays general device setting and resetting options.
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Clinical setup menu parameters*
Parameter
Modes
Range
Description
Settings
Circuit
Mask type
Full Face / Nasal
/ Pillows / Nasal
Ultra / Pediatric
Selects the type of mask used
by the patient.
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9 9 9 9 9 9 9 9 9 9
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Default: Full Face
Tube type
AB filter
SlimLine /
Standard / 3 m
Shows the type of air tubing
used by the patient.
Default: Standard Not displayed if ClimateLine or
ClimateLineMAX is connected
No /Yes
Enables or disables antibacterial
filter.
Default: No
Not displayed if H5i is
connected.
Ext.
humidifier
No /Yes
Enables or disables an external
humidifier.
9 9 9 9 9 9 9 9 9 9
Default: No
Therapy
Mode
CPAP / S / ST /
T / PAC / iVAPS /
ASVAuto / ASV /
AustoSet / VAuto
Sets the therapy mode available
on the device.
9 9 9 9 9 9 9 9 9 9
Default: CPAP
Set pressure
4–20 cm H2O
Sets the fixed treatment
pressure.
9
Default:
4 cm H2O
EPR Level
Height
Off / 1 / 2 / 3
Sets the EPR value.
9 9
Default: 3
44-100 inches
(110–250 cm)
Body height needed for the
dead space determination.
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Default: 70 inches
(175 cm)
Target Pt
Rate
8–30 BPM
The rate input to the iVAPS
algorithm. This should be set at
the patient’s actual respiratory
rate.
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Default: 15 BPM
Target Va
IPAP
1–30 L/min
Used to determine the amount
of pressure support required by
the iVAPS algorithm.
9
Default: 5.2 L/min
4–30 cm H2O
Sets the pressure which will be
delivered to the patient when
the device is triggered into
inspiration.
9 9 9 9
Default:
10 cm H2O
*Default settings may differ from country to country
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Parameter
Modes
Range
Description
EPAP
3–25 cm H2O**
Sets the pressure which will
be delivered to the patient
when the device is cycled into
expiration.
9 9 9 9 9 9
Default:
4 cm H2O
Dependent on IPAP.
Min PS
Max PS
0–20 cm H2O
Minimum pressure support in
iVAPS mode.
9 9 9
Default:
4 cm H2O
Dependent on EPAP.
0–28 cm H2O
Maximum pressure support in
iVAPS mode.
9 9 9
Default:
20 cm H2O
Dependent on EPAP and Min
PS.
Respiratory
Rate
5–50 BPM
Sets the breaths per minute
(BPM) or ‘backup’ rate.
9 9 9
Default: 10 BPM
Ti Max
Ti Min
Ti
0.3–4.0 sec
Sets the maximum limit on the
time the device spends in IPAP.
9 9 9
9
9
Default: 2 sec
Dependent on Respiratory Rate.
0.1–4.0 sec
Sets the minimum limit on the
time the device spends in IPAP.
9 9 9
Default: 0.3 sec
Dependent onTi Max.
0.1–4.0 sec
Sets the duration of inspiration
in timed breath.
9 9
Default: 2 sec
Dependent on Respiratory Rate.
RiseTime
Trigger
Min /
Sets the time taken for the
device to reach to IPAP.
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100–900 ms
Default: 150 ms
Dependent onTi Max andTi.
Very Low / Low /
Med / High / Very
High
Sets the level of inspiratory flow
above which the device changes
from EPAP to IPAP.
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Default: Med
Cycle
Very Low / Low /
Med / High / Very
High
Sets the level of inspiratory flow
below which the device changes
from IPAP to EPAP.
9 9 9
9
Default: Med
Max IPAP
Min EPAP
4–25 cm H2O
Sets the maximum inspiratory
pressure delivered by the
device.
9
9
Default:
25 cm H2O
4–[Max IPAP]
cm H2O
Sets the minimum expiratory
pressure delivered by the
device.
Default:
4 cm H2O
Pressure
Support
0–10 cm H2O
Difference between IPAP and
EPAP. Adjust for patient comfort.
9
Default:
4 cm H2O
** 2-25 cm H2O for Europe and APAC
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English
Parameter
Modes
Range
Description
Easy-
Breathe
(US Only)
On / Off
Enables Easy-Breathe comfort
feature.
9
Default: On
Max
Min–20 cm H2O,
0.2 cm H2O
Sets the upper limit of
treatment pressure.
9
9
Pressure
increments
Default:
20 cm H2O
Min
Pressure
4–Max cm H2O,
0.2 cm H2O
increments
Sets the lower limit of treatment
pressure.
Default:
4 cm H2O
Min EPAP
Max EPAP
Options
4–15 cm H2O
Sets the minimum EPAP
delivered by the device.
9
9
Default:
4 cm H2O
4–15 cm H2O
Sets the maximum EPAP
delivered by the device.
Dependent on Min EPAP.
Default:
15 cm H2O
Climate
Control
Auto / Manual
Sets the type of Climate
Control.
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9 9 9 9 9 9 9 9 9 9
Default: Auto
Therapy LED
On / Off
Enables or disables the blue
LED.
Default: Off
Date
Time
DD MmmYYYY
00:00 (24 hr)
Sets the current date or time.
If you set a new date or time
that occurs in the past then an
‘Invalid date/time, data exists
for this period’ message is
displayed.
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Configuration
Language
English / Français / Sets the display language.
9 9 9 9 9 9 9 9 9 9
Deutsch /
Español /
Português
Default: English
Restore
factory
defaults
Yes / No
Resets machine default settings
(except for language, date and
time).
9 9 9 9 9 9 9 9 9 9
Pressure
units
cm H2O / hPa
Sets pressure unit.
Sets temperature unit.
Sets height unit.
9 9 9 9 9 9 9 9 9 9
9 9 9 9 9 9 9 9 9 9
9 9 9 9 9 9 9 9 9 9
Default: cm H2O
Temperature
units
°F / °C
Default: °F
Height units
cm / inches
Default: inches
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Info menu
Service
Displays the device run hours, software version and other component
versions.
Parameter
Description
Run hours Displays the total number of hours the device has been used including warm-up and
cool-down times for the humidifier.
SW
BID
VID
AID
HID
Displays the current software version.
Displays the boot loader ID.
Displays the variant ID.
Displays the alarm software ID
Displays the humidifier software ID.
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Managing Climate Control
Designed to be ideal for most patients, Climate Control Auto enables the automatic delivery of a constant
value of absolute humidity while protecting against rainout.
To allow for increased flexibility, Climate Control can be turned to Manual in the Setup menu. Setting
Climate Control to Manual disables the automatic control of humidity and allows humidity and
temperature levels to be set independently. However, rainout protection is not provided when Climate
Control is set to Manual.
Humidity
Setting range Default settings
Climate Control
Temperature
Mode
Setting range
Default settings
Climate Control – Auto
Constant
absolute humidity
(depending on
temperature
setting)
–
Off*, 60ºF–86ºF
(16ºC–30ºC)
80ºF (27ºC)
Climate Control –
Manual
Humidity level
Heated tube
Off–6.0
(0.5 increments)
3
Off, 60ºF–86ºF
(16ºC–30ºC)
80ºF (27ºC)
* When the temperature setting is set to Off the tube will not heat the air, nor will the humidifier heat the water to
add humidity to the air.
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Delivering therapy
WARNING
Blocking the air tubing and/or air inlet of the device while in operation could lead to overheating of
the device.
CAUTION
Make sure the area around the device is dry and clean and clear of bedding, clothes or other
objects that could block the air inlet or cover the power supply unit.
The following procedure describes the steps required to start therapy at the patient’s bedside using the
S9 VPAPTx. Once these steps are completed, S9 VPAPTx can be remotely controlled from the EasyCare
Tx software application on the PC.
1. Make sure power is connected.
2. Check the mask type is correct (see “Mask and air tubing settings” on
page 10).
3. Fit the mask to patient, and adjust the mask and headgear to achieve
optimal fit.
4. Perform mask fit (see “Mask Fit” on page 12).
Once therapy has started a treatment screen is displayed.
In order to assist the heater plate in cooling, the device will continue to blow air for up to an hour after
treatment has stopped. However, you can unplug the device from the power outlet at any time and allow
the heater plate to cool without air flow, or press
to enable Power Save mode.
Note: If power is interrupted during treatment, the device automatically restarts therapy when power is
restored.
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Adding supplemental oxygen
WARNING
•
•
Explosion hazard—do not use in the vicinity of flammable anesthetics.
Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of
an open flame.
Always ensure that the device is turned on and airflow generated before the oxygen supply is
turned on. Always turn the oxygen supply off before the device is turned off, so that unused
oxygen does not accumulate within the device enclosure and create a risk of fire.
•
The S9 VPAPTx is designed to be compatible with the following levels of supplemental oxygen:
•
•
up to 15 L/min for CPAP, S, T, ST, ASV and PAC modes
up to 4 L/min for AutoSet, VAuto, iVAPS and ASVAuto modes.
At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary depending on:
•
•
•
•
•
where the oxygen is introduced;
the pressure settings;
patient breathing pattern;
mask selection; and
leak rate.
Adding oxygen may affect the trigger and cycle reliability, delivered pressure, and the accuracy of the
displayed leak, tidal volume, minute ventilation and alveolar ventilation.
To add supplemental oxygen:
1.
Fit the ResMed Oxygen Connector Port to the air outlet of the S9 VPAPTx and fit the air tubing to
the oxygen connector.
2. Fit the oxygen supply tubing to the port on the oxygen connector.
3. Attach the other end of the oxygen supply tubing to an oxygen flowmeter.
4. Optimize the therapy device settings first, and then add oxygen if baseline saturation remains low.
5. Titrate oxygen according to institutional guidelines.
6. Determine an initial oxygen flow rate during wakefulness. Only increase oxygen during sleep when
titration of pressure is complete.
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Cleaning and maintenance
Regular cleaning should be carried out on the S9 VPAPTx.
Clean the exterior of the device with a damp cloth and mild detergent.
Reprocessing the H5i and air tubing between patients
The H5i and air tubing should be reprocessed when used between patients. Cleaning and disinfection
Support. If you do not have internet access, please contact your ResMed representative.
Replacing the air filter
Inspect the air filter for holes and check whether it is blocked by dirt or dust. With normal use of the
S9 VPAPTx, the air filter needs to be replaced every six months (or more often in a dusty environment).
1. Remove the air filter cover from the back of the device.
2. Remove and discard the old filter.
3. Insert a new ResMed air filter ensuring that it is sitting flat in the air filter cover.
4. Replace the air filter cover.
Notes:
•
Ensure the air filter and air filter cover
are fitted at all times.
•
Do not wash the air filter.
The air filter is not washable
or reusable.
Air filter cover
Air filter
The following filters are available for use with the S9 VPAPTx:
Filter
Efficiency
Standard (ASMB 160)
88% at 7 micron
Hypo-allergenic (Air Safety Electret100 – electrostatic filter) 89.8% at 0.5 micron, bacterial
efficiency of 99.54%.
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Working with alarms
The S9 VPAPTx is fitted with an alarm module that continuously monitors both therapy and device
conditions. Alarms are only activated when therapy is running. An alarm condition can be indicated by an
audible sound, a flashing yellow LED or a message on the screen.
Note:The alarms should be tested after final system setup to ensure the alarms work as required.
Alarms menu
The alarms pre-set for the device are:
•
•
•
Power fail
Blocked tube*
System fault (system error).
* Blocked tube alarm is only triggered reliably for pressures above 10 cm H2O.
If the system has not been properly assembled, the device will trigger an alarm. Check that the air tubing
has been properly attached to the device, mask and humidifier.
Clearing the alarm message
When an alarm activates, a corresponding alarm message is displayed.
To clear an alarm message, press
previously displayed screen.
. This allows you to return to the
Note: Alarms are cleared by pressing
.
Testing the alarms
When the device is turned on, the alarm LED will flash and the alarm will sound to confirm that the alarm
is working.
To test the alarm manually or to adjust the alarm volume using the menus, go to the Settings menu and
select Alarm Vol/Test. When the setting is selected and confirmed, the alarm will sound and all LEDs will
be active.
The alarms should be tested weekly. To test some of the alarm conditions, follow the procedures
described below. When completed, stop therapy and return all settings to their original settings
appropriate to the patient before delivering therapy.
Power fail
1. Set up the device with the air tubing attached, but no mask.
2. Press the Start/Stop key to start therapy.
3. Unplug the DC plug of the power supply unit from the rear of the device. The alarm activates
immediately.
4. Plug the DC plug back in. The alarm stops.
Blocked tube
1. Set up the device with the air tubing attached, but no mask.
2. Set pressure above 12 cm H2O in CPAP mode.
Note: BlockedTube alarm only activates above 10 cm H2O.
3. Press the Start/Stop key to start therapy.
4. Block the air tubing with your hand. The alarm activates when tubing is blocked for 30–50 seconds.
5. Unblock the air tubing. The alarm stops.
System Fault
No testing for system fault.
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Troubleshooting
If there is a problem, try the following suggestions. If the problem cannot be solved, contact your
equipment supplier or ResMed. Do not attempt to open the device.
Problem/Possible cause
No display
Solution
Power is not connected.
Ensure the power cord is connected and the power outlet (if
available) is on.
The DC plug is partially inserted into Fully insert the DC plug.
the back of the device or inserted
too slowly.
The S9 VPAPTx and H5i are not
connected correctly.
Ensure that the S9 VPAPTx and H5i are securely attached.
Insufficient air delivered from the device
Air filter is dirty.
Replace air filter.
Air tubing is not connected properly. Check air tubing.
Air tubing is blocked, pinched or
punctured.
Unblock or free the air tubing. Check the air tubing for
punctures.
Mask and headgear are not
positioned correctly.
Adjust position of mask and headgear.
Incorrect air tubing selected.
If you are using the SlimLine, Standard or 3 m air tubing ensure
that you have the correct air tubing selected via the menu.
The H5i flip lid is not latched
correctly.
Close the flip lid ensuring that it clicks into place.
The H5i flip lid seal is not fitted
correctly.
Make sure the flip lid seal is facing the right way up and fitted
securely.
Mask vents might be blocked.
Check if you have sufficient venting. Unblock mask vents if
necessary.
EPAP may be set too low.
There is excessive leak.
Adjust EPAP settings.
Adjust position of mask and headgear.
Pressure rises inappropriately
Talking, coughing or breathing in an
unusual manner.
Avoid talking with a nasal mask on, and breathe as normally as
possible.
Mask cushion is buzzing against the Adjust the headgear.
skin.
Cushion seated incorrectly causing
excessive leak.
Adjust headgear or re-fit cushion.
Displays message: Heated tube fault, replace tube
Device has been left in a hot
environment.
Allow to cool before re-use. Disconnect the power cord and
then reconnect it to restart the device.
There is a fault in your ClimateLine
or ClimateLineMAX heated air tubing.
Discontinue using your ClimateLine or ClimateLineMAX heated
air tubing and contact your service provider. Use SlimLine,
Standard or 3 m air tubing in the interim.
Displays message: High temperature fault, refer to user manual
Device has been left in a hot
environment.
Allow to cool before re-use. Disconnect the power cord and
then reconnect it to restart the device.
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Problem/Possible cause
Solution
Air filter is blocked.
Replace your air filter. Disconnect the power cord and then
reconnect it to restart the device.
Air tubing is blocked.
Check your air tubing and remove any blockages. Disconnect
the power cord and then reconnect it to restart the device.
Humidity level setting is too high,
Turn the humidity level setting down and empty the water from
resulting in accumulation of water in the air tubing.
the air tubing.
Displays message: Check ResMed 30/90W Power Supply Unit and fully insert the connector
The DC plug is partially inserted into Fully insert the DC plug.
the back of the device or inserted
too slowly.
A non-ResMed power supply unit is
connected to the device.
Remove the power supply unit and replace with a ResMed
power supply unit.
The power supply unit is being
covered by bedding.
Make sure that the power supply unit is free from bedding,
clothes or other objects that could cover it.
Water splashing on your face from the H5i
The water tub is overfilled.
Check that the water level is below the maximum water level
mark.
Condensation is forming in the air
tubing and mask.
Turn the humidity level setting down via the menu.
Leaking water tub
The water tub may be damaged or
cracked.
Contact your service provider for a replacement.
The cleanable water tub is not
assembled correctly.
Check for damage and reassemble the cleanable water tub
correctly.
Air feels too warm/cold in the mask
The temperature of the ClimateLine
or ClimateLineMAX heated air tubing
is set too high/low.
Turn up/down the heated air tubing temperature via the menu.
Alarm is activated and the LCD screen display disappears
Power failure.
Remove the patient’s mask until power is restored.
Power cord is disconnected or mains Ensure the power cord is connected and the mains power
power switch is turned off during
therapy.
outlet (if available) is on.
Displays message: Tube blocked, please check your tube
Air tubing is blocked. Check the air tubing and remove any blockages. Disconnect the
power cord and then reconnect it to restart the device.
Displays message: Alarm module fault, please contact service provider
General failure of the device and/or
the alarm module. Therapy cannot
be started again.
Contact your service provider immediately.
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Technical specifications
General technical specifications
Power supply
90W power supply unit
Input range: 100–240V; 50–60Hz; 115V, 400Hz nominal for aircraft use
Typical power consumption: 70W (80VA)
Maximum power consumption: 110W (120VA)
90W DC/DC converter
Nominal inputs: 12V, 24V
Typical power consumption: 70W
Maximum power consumption: 110W
Environmental
conditions
Operating temperature: +41ºF to +95ºF (+5ºC to +35ºC)
Note: The air flow for breathing produced by this therapy device can be higher
than the temperature of the room. Under extreme ambient temperature conditions
(104°F/40°C) the device remains safe.
Operating humidity:10 to 95% non-condensing
Operating altitude: Sea level to 8,500’ (2,591 m); air pressure range 1013 hPa to
738 hPa
Storage and transport temperature: -4ºF to +140ºF (-20ºC to +60ºC)
Storage and transport humidity: 10 to 95% non-condensing
Electromagnetic Product complies with all applicable electromagnetic compatibility requirements
compatibility
(EMC) according to IEC60601-1-2, for residential, commercial, and light industry
environments.
It is recommended that mobile communication devices are kept at least one
meter away from the device.
Information regarding the electromagnetic emissions and immunity of these
Service and Support. Click on the PDF file for your language.
Aircraft use
ResMed confirms that the S9 VPAPTx meets the Federal Aviation Administration
(FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air
travel.
IEC 60601-1
classification
Class II (double insulation), Type BF, Ingress Protection IP21
Measuring and
display devices
Pressure sensor: Internally located at device outlet, analog gauge pressure type,
-5 to +45 cm H2O
Flow sensor: Internally located at device inlet, digital mass flow type,
-70 to +200 L/min
S9VPAPTx technical specifications
Mode pressure
ranges
CPAP, AutoSet mode
Pressure: 4–20 cm H2O;
S, ST, T and PAC mode
IPAP: 4–30 cm H2O; EPAP: 2–25 cm H2O;
iVAPS mode
PS: 0–27 cm H2O; EPAP: 2–25 cm H2O;
VAuto mode
PS: 0-10 cm H2O; Min EPAP: 4 cm H2O; Max IPAP: 25 cm H2O;
ASV and ASVAuto mode
PS: 0–20 cm H2O; EPAP: 4–15 cm H2O;
Maximum single Maximum single fault steady state pressure: 30 cm H2O—if pressure exceeded
fault pressure
for > 6 sec; 40 cm H2O—if pressure exceeded for >1 sec
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Sound:
Sound pressure level (CPAP mode)
DECLARED
DUAL-NUMBER
NOISE
with SlimLine air tubing: 26 dBA with uncertainty of 2 dBA as measured
according to ISO 17510-1:2007
EMISSION
VALUES in
accordance with
ISO 4871:1996
with Standard air tubing: 27 dBA with uncertainty of 2 dBA as measured
according to ISO 17510-1:2007
with either SlimLine or 28 dBA with uncertainty of 2 dBA as measured
Standard air tubing and H5i: according to ISO 17510-1:2007
Sound power level (CPAP mode)
with SlimLine air tubing: 34 dBA with uncertainty of 2 dBA as measured
according to ISO 17510-1:2007
with Standard air tubing: 35 dBA with uncertainty of 2 dBA as measured
according to ISO 17510-1:2007
with either SlimLine or 36 dBA with uncertainty of 2 dBA as measured
Standard air tubing and H5i: according to ISO 17510-1:2007
Alarm volume
settings
Low (nominal 56 dBA), Medium (nominal 68 dBA), High (nominal 80 dBA)
Physical
Dimensions (L x W x H): 6.0” x 6.8” x 3.4” (153 mm x 172 mm x 86 mm)
Weight: 2.30 lbs (1.045 kg)
Housing construction: Flame retardant engineering thermoplastic
Air outlet: 22 mm conical air outlet (complies with ISO 5356-1:2004)
Air filter
Standard: Polyester non-woven fiber
Hypoallergenic: Acrylic and polypropylene fibers in a polypropylene carrier
Supplemental
oxygen
Recommended maximum supplemental oxygen: 15 L/min (CPAP, S, T, ST, ASV and
PAC modes), 4 L/min (AutoSet, VAuto, iVAPS and ASVAuto modes)
Pneumatic flow path
1
3
3
2
4
1. Flow sensor
2. Blower
3. Pressure sensor
4. Mask
5. Air tubing
6. H5i
7. Alarm module
8. Device
9. Inlet filter
9
6
7
8
5
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Flow (maximum) at set pressures
The following are measured at the end of the specified air tubing:
Pressure
cm H2O
S9VPAPTx and
standard air
tubing,
S9VPAPTx, H5i
and standard air
tubing,
S9VPAPTx and
SlimLine,
L/min
S9VPAPTx, H5i
and ClimateLine,
L/min
L/min
L/min
4
8
12
16
20
25
200
200
200
200
190
180
170
170
170
170
170
161
195
190
184
175
168
144
170
170
170
170
161
125
Displayed values
Value
Range
Display resolution
Pressure sensor at air outlet
Mask pressure
Flow derived values
Leak
3–30 cm H2O
0.1 cm H2O
0–200 L/min
0–4000 mL
0–50 BPM
0–30 L/min
0.1–4.0 sec
1:50–2:1
1 L/min
1 mL
Tidal volume
Respiratory rate
Minute ventilation
Ti
1 BPM
0.1 L/min
0.1 sec
0.1
I:E ratio
Value
Accuracy1
Pressure measurement1
Mask pressure
Flow measurements1
Leak2
0.5 cm H2O (+ 4% of measured value)
12 L/min or 20% of reading, whichever is greater, at 0 to 60 L/min
Tidal volume2
Respiratory rate2
Minute ventilation2
20%
1.0 BPM
20%
1 Results are expressed at ATPD (AmbientTemperature and Pressure, Dry)
2 Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation
<3 L/min.
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Symbols
The following symbols may appear on your product or packaging.
Caution;
vertically dripping water;
European Authorised Representative;
number; Serial number; Direct current;
pollution control logo 2; Not drip proof; Keep dry;
Read instructions before use;
Protection against insertion of fingers and against
Type BF equipment;
Class II equipment;
European RoHS; Batch code;
China pollution control logo 1;
Start/Stop;
Manufacturer;
Catalogue
China
Prescription only (In the US, Federal
law restricts these devices to sale by or on the order of a physician.).
Environmental information
WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic
equipment. This device should be disposed of separately, not as unsorted municipal waste. To dispose of
your device, you should use appropriate collection, reuse and recycling systems available in your region.
The use of these collection, reuse and recycling systems is designed to reduce pressure on natural
resources and prevent hazardous substances from damaging the environment.
If you need information on these disposal systems, please contact your local waste administration. The
crossed-bin symbol invites you to use these disposal systems. If you require information on collection
and disposal of your ResMed device please contact your ResMed office, local distributor or go to
Servicing
The S9 VPAPTx is intended to provide safe and reliable operation when operated in accordance with the
instructions provided by ResMed. ResMed recommends that the S9 VPAPTx be inspected and serviced
by an authorized ResMed Service Center if there is any sign of wear or concern with device function.
Otherwise, service and inspection of the devices generally should not be required during the five year
design life of the device.
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Limited warranty
ResMed Ltd (hereafter ‘ResMed’) warrants that your ResMed product shall be free from defects in
material and workmanship from the date of purchase for the period specified below.
Product
Warranty period
Mask systems (including mask frame, cushion, headgear and tubing)—excluding
single-use devices
90 days
Accessories—excluding single-use devices
Humidifier water tubs
Batteries for use in ResMed internal and external battery systems
CPAP and bilevel device data modules
Humidifiers and humidifier cleanable water tubs
Titration control devices
6 months
1 year
CPAP, bilevel and ventilation devices (including external power supply units)
Battery accessories
2 years
Portable diagnostic/screening devices
This warranty is only available to the initial consumer. It is not transferable.
If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the
defective product or any of its components.
This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse,
modification or alteration of the product; b) repairs carried out by any service organization that has not
been expressly authorized by ResMed to perform such repairs; and c) any damage or contamination due
to cigarette, pipe, cigar or other smoke; and d) any damage cause by water being spilled on or into an
electronic device.
Warranty is void on product sold, or resold, outside the region of original purchase.
Warranty claims on defective product must be made by the initial consumer at the point of purchase.
This warranty replaces all other expressed or implied warranties, including any implied warranty of
merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how
long an implied warranty lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted
from the sale, installation or use of any ResMed product. Some regions or states do not allow the
exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to
you.
This warranty gives you specific legal rights, and you may also have other rights which vary from region
to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed
office.
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258189/2 2013-02
S9 VPAPTx
CLINICAL
GLO MULTI
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.
S9, H5i, ClimateLine, SlimLine, SmartStart, TiControl and VPAP are trademarks of ResMed Ltd. S9, ClimateLine, SlimLine,
SmartStart and VPAP are registered in U.S. Patent and Trademark Office.
© 2013 ResMed Ltd.
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