ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia • ResMed Corp (US
Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA • ResMed (UK) Ltd (EU Authorised
Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK • ResMed Offices Australia, Austria, Brazil, China,
Finland, France, Germany, Hong Kong, India, Japan, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain,
Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).
Protected by patents: AU 697652, EP 0661071, US 4944310, US 5199424, US 5522382, US 6240921, US 6705315.
Other patents pending.
Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186,
CN 200430121212.2, CN 200430121213.7, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN
Thank you for choosing the S8 Elite™ II flow generator. The S8 Elite IIis a
compact, all-in-one package with an inbuilt power supply and the option of
integrated data management and humidification.
This user manual contains the information you need for the correct use of your
S8 Elite II.
Your Responsibility
The owner or user of this system shall have sole responsibility and liability for any
injury to persons or damage to property resulting from:
• operation which is not in accordance with the operating instructions supplied
• maintenance or modifications carried out unless in accordance with
authorised instructions and by authorised persons.
Please read this manual carefully before use.
This manual contains special terms and icons that appear in the margins to draw
your attention to specific and important information.
• Warning alerts you to possible injury.
• Caution explains special measures for the safe and effective use of the
device.
• Note is an informative or helpful note.
1Introduction
Medical Information
About the S8 Elite II
TheS8 Elite II continuous positive airway pressure (CPAP) system is indicated
for the treatment of obstructive sleep apnoea (OSA) in adult patients.
The S8 Elite IICPAP system is intended for home and hospital use.
Contraindications
The S8 Elite II is not a life support device and may stop operating during power
failure or certain fault conditions. It should not be used by patients who are
dependent on continuous therapy.
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.
Warnings
• The entire manual should be read before using the S8 Elite II.
• Advice contained in this manual should not supersede instructions given by
the prescribing physician.
• A patient should not connect a device to the data communication port unless
instructed to do so by their health care provider or physician. Only ResMed
products are designed to be connected to the data communication port.
Connecting other devices could result in injury, or damage to the S8 Elite II
device.
• The S8 Elite II should be used with masks (and connectors)
by ResMed, or by a physician or respiratory therapist. A mask should not be
used unless the S8 Elite II device is turned on and operating properly. The
vent hole or holes associated with the mask should never be blocked.
Explanation: The S8 Elite II is intended to be used with special masks (or
connectors)1 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
1
recommended
1 Ports may be incorporated into the mask or in connectors that are near the mask.
2Medical Information
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 devices.
• In the event of power failure or machine malfunction, remove the mask.
• The S8 Elite II can be set to deliver pressures up to 20 cm H
O. In the
2
unlikely event of certain fault conditions, pressures up to 30 cm H2O are
possible.
• If oxygen is used with this device, the oxygen flow must be turned off when
the device is not operating. If oxygen has been left on while the device is not
operating, disconnect the oxygen and wait 30 minutes before turning on the
device.
Explanation: When the CPAP device is not in operation and the oxygen flow
is left on, oxygen delivered into the air delivery tubing may accumulate within
the CPAP machine enclosure and create a risk of fire. This applies to most
types of CPAP machines.
• Oxygen supports combustion. Oxygen should not be used while you are
smoking or in the presence of an open flame.
• Always ensure airflow is being generated by the device before the oxygen
supply is turned on.
• Always turn the oxygen supply off before stopping the airflow from the
device.
Note: 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.
• Do not use the S8 Elite II if there are obvious external defects or unexplained
changes in performance.
• Do not open the S8 Elite II case. There are no user serviceable parts inside.
Repairs and internal servicing should only be performed by an authorised
service agent.
• Explosion hazard—do not use in the vicinity of flammable anesthetics.
Cautions
• At low pressures, the flow through the exhalation ports of your mask may not
clear all exhaled gas from the tubing. Some rebreathing may occur.
• The airflow for breathing produced by this device can be as much as 6°C
higher than the temperature of the room. Caution should be exercised if the
room temperature is warmer than 32°C.
• When AC mains power (100–240V AC) is not available, always use a ResMed
DC-12 converter. (The DC-12 converter is available as an optional accessory.)
• If supplied, the ResScan™ Data Card module is designed for use with
specific ResMed devices.
• Only use the ResScanData Card module (if supplied) as specified in this
manual.
3Medical Information
Note: The above are general warnings and cautions. Specific warnings, cautions
and notes appear with the relevant instructions in the manual.
Adverse Effects
Patients should report unusual chest pain, severe headache or increased
breathlessness to their prescribing physician. An acute upper respiratory tract
infection may require temporary discontinuation of treatment.
The following side effects may arise during the course of therapy with the S8
device:
• drying of the nose, mouth or throat
• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes
• chest discomfort.
4Medical Information
The S8 Elite II System
The S8 Elite II device is part of a system that consists of five elements:
• S8 Elite II flow generator
• Mask
• Humidifier
• Data management products
• Accessories.
S8 Elite II
Please refer to the illustrations in section A of the illustration sheet.
Front view (A-1)
Shows the keypad and LCD screen, and the air outlet.
Rear view (A-2)
Shows where the module attaches, and the location of the air filter and power
sockets.
Power cord (A-3)
Power cord to attach the S8 Elite IIto the AC (mains) power.
Travel bag (A-4)
Air tubing
The 2 m air tubing connects the S8 Elite IIto your mask.
Masks
You will also need a ResMed mask system (supplied separately).
The ResMed mask systems that are recommended for use with the S8 Elite II
are:
Nasal Masks
• Mirage Vista™ Nasal Mask
• Ultra Mirage™ II Nasal Mask
• Mirage™ Nasal Mask
• Mirage Activa™ Nasal Mask
• Papillon™.
Nasal Pillows Systems
• Mirage Swift™ Nasal Pillows System
• Mirage Swift™ II Nasal Pillows System.
Full Face Masks
• Mirage Liberty™ Full Face Mask
• Mirage Quattro™ Full Face Mask
• Ultra Mirage™ Full Face Mask.
Note: Not all masks are available in all regions.
(A-5)
5The S8 Elite II System
WARNING
!
For optimal product performance and data recording, ResMed mask
systems should be used with the S8 Elite II. Please refer to “Warnings” on
page 2.
Humidifier
Please refer to the illustration in section B of the illustration sheet.
A humidifier may be required if you are experiencing dryness of the nose, throat
or mouth. The S8 Elite II is compatible for use with the HumidAire 3iintegrated
heatedhumidifier.
ResScan Data Card Module
The ResScan™ Data Card module and ResScan Data Card (C-1) may be used
with the S8 Elite II either to help your clinician to monitor your treatment or to
provide you with updates to your device settings. See “Using a ResScan Data
Card Module” on page 20 for information about how to use the Data Card
module and Data Card.
Accessories
Please refer to the illustrations in section C of the illustration sheet.
Other accessories for use with the S8 Elite II:
• Front cap (not available in all regions) (C-2)
• Air tubing (3 m) (C-3)
• DC-12 converter (C-4)
• Blank module (C-5).
Note: ResMed regularly releases new products. Please check our website at
www.resmed.com.
6The S8 Elite II System
How to Use the S8 Elite II
Please refer to the illustrations in section D of the illustration sheet.
Set Up the S8 Elite II
1 Place the S8 Elite II on a table near the head of your bed.
CAUTION
!
Be careful not to place the device where it can be bumped or where
someone is likely to trip over the power cord.
Note: You can also place your S8 Elite II on the floor beside or underneath your
bed. Ensure that the area is free from dust and clear of bedding, clothes or any
other objects that could block the air inlet.
2 Connect the power cord to the socket at the rear of the flow generator (D-1). Plug
the other end of the power cord into the power outlet.
WARNING
!
Make sure the power cord and plug are in good condition and the
equipment is not damaged.
3 Connect one end of the air tubing firmly onto the air outlet (D-2).
WARNING
!
• Only ResMed air tubing should be used with your flow generator. A
different type of air tubing may alter the pressure you actually receive,
reducing the effectiveness of your treatment.
• Blocking the air inlet or tubing while in operation could lead to
overheating of the device.
• In the clinical environment any personal computer that is used with your
CPAP system must be at least 1.5 m away from, or at least 2.5 m above,
the patient. It must also comply with the relevant test standard. For
personal computers the international standard is IEC 60950 or
equivalent.
Assemble the Mask
1 Assemble your mask system according to the mask user instructions.
2 Connect your mask system to the free end of the air tubing (D-3).
3 Check that the mask setting on the MASK screen is the one recommended for
the mask you are using (see the table in “How to Select the Mask Type” on
page 17).
The S8 Elite II is now ready for use (D-4).
7How to Use the S8 Elite II
Start Treatment
1 Make sure the power is on.
A welcome message is displayed briefly on the LCD screen, then the standby
(Ramp) screen appears. The key and LCD backlights also turn on.
2 Lie down and arrange the air tubing so that it is free to move if you turn in your
sleep.
CAUTION
!
• Do not leave long lengths of air tubing around the top of your bed. They
could twist around your head or neck while you are sleeping.
• Make sure the area around the flow generator is dry and clean. It should
also be clear of bedding, clothes and other potential blockages.
3 Alter the ramp time if required (see “How to Change the Ramp Time” on
page 13).
To start treatment, press the Start/Stop key, unless your clinician has set up
your device to start delivering therapy automatically. If so, your device will start
when you breathe into your mask (see “SmartStart” for details).
4 Fit your mask as described in the mask user instructions.
WARNING
!
A mask should not be used unless the S8 Elite II device is powered and
operating properly.
5 When ramping begins, the LCD will display the word "RAMPING", with the
current pressure indicated as dashes. Each dash is approximately equivalent to
2 cm H
pressure.
SmartStart
The S8 Elite II has a function called SmartStart™ that your clinician can enable. If
SmartStart is enabled, your device will start automatically when you breathe into
your mask, and will stop automatically when you take your mask off. This means
you do not have to press the Start/Stop key to begin or end treatment.
Note: Do not use SmartStart when using a mask with an anti-asphyxia valve,
such as the Mirage Full Face Mask.
O. For example, 6 dashes represents approximately 12 cm H2O
2
™
Stopping Treatment
To stop treatment at any time, remove your mask and press the Start/Stop key
or
if your clinician has enabled SmartStart, simply remove your mask and treatment
will end.
8How to Use the S8 Elite II
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