Airstart 10 - User Guide Device Only - Apac - Eng PDF
Airstart 10 - User Guide Device Only - Apac - Eng PDF
English
ENGLISH
Welcome
The AirStart™ 10 APAP and AirStart 10 CPAP are ResMed's Automatic Positive Airway Pressure
(APAP) and Continuous Positive Airway Pressure (CPAP) devices.
WARNING
Read this entire guide before using the device.
Use the device according to the intended use provided in this guide.
The advice provided by your prescribing doctor should be followed ahead of the
information provided in this guide.
AirStart 10 CPAP
The AirStart 10 CPAP device is indicated for the treatment of obstructive sleep apnoea (OSA) in
patients weighing more than 30 kg. It is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a
hospital/institutional environment.
Contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following pre-
existing conditions:
severe bullous lung disease
pneumothorax
pathologically low blood pressure
dehydration
cerebrospinal fluid leak, recent cranial surgery, or trauma.
Adverse effects
You should report unusual chest pain, severe headache, or increased breathlessness to your
prescribing physician. An acute upper respiratory tract infection may require temporary
discontinuation of treatment.
The following side effects may arise during the course of therapy with the device:
drying of the nose, mouth, or throat
nosebleed
bloating
ear or sinus discomfort
eye irritation
skin rashes.
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At a glance
The AirStart 10 can include the following:
Device
Air tubing
Standard filter (already inserted)
Power supply unit
Travel bag
SD card (already inserted).
Contact your care provider for a range of accessories available for use with the device including:
Air tubing: SlimLine™, Standard
Humidifier: Standard humidifier (for single patient use only, cannot be disinfected), cleanable
humidifier (for multi-patient use, can be disinfected)
Side cover (for use without humidifier)
Filter: Hypoallergenic filter, standard filter
Air10™ DC/DC converter
SD card reader
Air10 USB adapter.
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About the control panel
Press to start/stop therapy.
Start/Stop button Press and hold for three seconds to enter power save
mode.
The Ramp Time icon is displayed on the screen when ramp is on.
Setup
Starting therapy
1. Fit your mask.
2. Press Start/Stop.
You will know that therapy is on when the Sleep Report screen is displayed.
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The current treatment pressure is shown in the centre of the screen.
During ramp time the pressure is gradually increasing and you will see a
spinning circle. Once the prescribed treatment pressure is reached, the entire
circle will be solid.
The screen will go black automatically after a short period of time. You can press Home or Select to
turn it back on. If power is interrupted during therapy, the device will automatically restart therapy
when power is restored.
Stopping therapy
1. Remove your mask.
2. Press Start/Stop.
The Sleep Report now gives you a summary of your therapy session.
Usage hours–Indicates the number of hours of therapy you received last
session.
Mask Seal–Indicates how well your mask sealed:
My Options
Your AirStart 10 device has been set up for your needs by your care provider, but you may find you
want to make small adjustments to make your therapy more comfortable.
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Highlight My Options and press Select to see your
current settings. From here, you can personalise your
options.
Ramp Time
Designed to make the beginning of therapy more comfortable, Ramp Time is the period during
which the pressure increases from a low start pressure to the prescribed treatment pressure.
You can set your Ramp Time to Off or between 5 to 45 minutes.
More options
Your care provider may have given you access to personalise a few more options.
Pressure Relief When Pressure Relief is enabled, you may find it easier to breathe out. This
can help you get used to therapy.
Mask This option shows your mask type setting. If you use more than one type of
mask, adjust this setting when switching between masks.
Disassembling
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1. Hold the cuff of the air tubing and gently pull it away from the device.
2. Hold both the cuff of the air tubing and the swivel of the mask, then gently pull apart.
Cleaning
You should clean the device weekly as described. Refer to the mask user guide for detailed
instructions on cleaning your mask.
1. Wash the air tubing in warm water using mild detergent.
Do not wash in a dishwasher or washing machine.
2. Rinse the air tubing thoroughly and allow to dry out of direct sunlight and/or heat.
3. Wipe the exterior of the device with a dry cloth.
Checking
You should regularly check the air tubing and air filter for any damage.
1. Check the air tubing and replace it if there are any holes, tears or cracks.
2. Check the air filter and replace it at least every six months.
Replace more often if there are any holes or blockages by dirt or dust.
1. Open the air filter cover and remove the old air filter.
The air filter is not washable or reusable.
2. Place a new air filter onto the air filter cover and then close it.
Make sure the air filter is fitted at all times to prevent water and dust from entering the device.
Reassembling
When the air tubing is dry, you can reconnect it to the device.
1. Connect the air tubing firmly to the air outlet located on the rear of the device.
2. Connect the free end of the air tubing firmly onto the assembled mask.
Therapy data
Your AirStart 10 device records your therapy data for you and your care provider so they can view
and make changes to your therapy if required.
SD card
Your therapy data is stored the SD card. Your care provider may ask you to send the SD card by mail
or to bring it in. When instructed by your care provider, remove the SD card.
Do not remove the SD card from the device when the SD light is flashing.
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To remove the SD card:
Travelling
You can take your AirStart 10 device with you wherever you go. Just keep the following in mind:
Use the travel bag provided to prevent damage to the device.
Make sure you have the appropriate power cord for the region you are travelling to. For
information on purchasing, contact your care provider.
Travelling by plane
Your AirStart 10 device may be taken on board as carry-on luggage. Medical devices do not count
toward your carry-on luggage limit.
You can use your AirStart 10 device on a plane as it meets the Federal Aviation Administration (FAA)
requirements. Air travel compliance letters can be downloaded and printed from www.resmed.com.
Troubleshooting
If you have any problems, have a look at the following troubleshooting topics. If you are not able to
fix the problem, contact your care provider or ResMed. Do not try to open the device.
General troubleshooting
Problem/possible cause Solution
Air is leaking from around my mask
Mask may be fitted incorrectly. Make sure your mask is fitted correctly. See your mask user
guide for fitting instructions.
Air pressure in my mask seems too high (it feels like I am getting too much air)
Ramp may be turned off. Use the Ramp Time option.
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Problem/possible cause Solution
Air pressure in my mask seems too low (it feels like I am not getting enough air)
Ramp may be in progress. Wait for air pressure to build up or turn Ramp Time off.
My screen is black
Backlight on the screen may have turned off. It turns off Press Home or Select to turn it back on.
automatically after a short period of time.
Power may not be connected. Connect the power supply and make sure the plug is fully
inserted.
Device messages
Device message/possible cause Solution
High leak detected, connect your tubing
Air tubing may not be connected properly. Make sure the air tubing is firmly connected at both ends.
Mask may be fitted incorrectly. Make sure your mask is fitted correctly. See your mask user
guide for fitting instructions.
SD card error, remove your card and press Start to begin therapy
SD card may not be inserted correctly. Remove and reinsert the SD card.
All other error messages, for example, System fault, refer to user guide, Error 0XX
An unrecoverable error has occurred on the device. Contact your care provider. Do not open the device.
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General warnings and cautions
WARNING
Make sure that you arrange the air tubing so that it will not twist around the head or neck.
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.
If you notice any unexplained changes in the performance of the device, if it is making
unusual sounds, if the device or the power supply are dropped or mishandled, or if the
enclosure is broken, discontinue use and contact your care provider or your ResMed
Service Centre.
Do not open or modify the device. There are no user serviceable parts inside. Repairs and
servicing should only be performed by an authorised ResMed service agent.
Beware of electrocution. Do not immerse the device, power supply or power cord in water.
If liquids are spilled into or onto the device, unplug the device and let the parts dry. Always
unplug the device before cleaning and make sure that all parts are dry before plugging it
back in.
Supplemental oxygen must not be used while smoking or in the presence of an open
flame.
Always make sure 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.
Do not perform any maintenance tasks while the device is in operation.
The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The use of accessories other than those specified for the device is not recommended. They
may result in increased emissions or decreased immunity of the device.
CAUTION
Use only ResMed parts and accessories with the device. Non-ResMed parts may reduce the
effectiveness of the treatment and/or damage the device.
Use only vented masks recommended by ResMed or by the prescribing doctor with this
device. Fitting the mask without the device blowing air can result in rebreathing of exhaled
air. Make sure that the mask vent holes are kept clear and unblocked to maintain the flow
of the fresh air into the mask.
Be careful not to place the device where it can be bumped or where someone is likely to
trip over the power cord.
Blocking the air tubing and/or air inlet of the device while in operation could lead to
overheating of the device.
Keep the area around the device dry, clean and clear of anything (eg, clothes or bedding)
that could block the air inlet or cover the power supply unit.
Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is
correctly set up.
Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or
antibacterial soaps or scented oils to clean the device, the water tub or air tubing. These
solutions may cause damage or affect the humidifier performance and reduce the life of
the products.
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Technical specifications
Units are expressed in cm H2O and hPa. 1 cm H2O is equal to 0.98 hPa.
90W power supply unit
AC input range: 100–240V, 50–60Hz 1.0–1.5A, Class II
115V, 400Hz 1.5A, Class II (nominal for aircraft use)
DC output: 24V 3.75A
Typical power consumption: 53W (57VA)
Peak power consumption: 104W (108VA)
Environmental conditions
Operating temperature: +5°C to +35°C
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 (40°C) the
device remains safe.
Operating humidity: 10 to 95% relative humidity, non-condensing
Operating altitude: Sea level to 2,591 m; air pressure range 1013 hPa to
738 hPa
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: 5 to 95% relative humidity, non-condensing
Electromagnetic compatibility
The AirStart 10 complies with all applicable electromagnetic compatibility requirements (EMC) according to
IEC60601-1-2:2007, for residential, commercial and light industry environments. It is recommended that mobile
communication devices are kept at least 1 m away from the device.
Information regarding the electromagnetic emissions and immunity of this ResMed device can be found on
www.resmed.com, on the Products page under Service and Support.
EN 60601-1:2006 classification
Class II (double insulation), Type BF, Ingress protection IP22.
Sensors
Pressure sensor: Internally located at device outlet, analogue gauge pressure
type, -5 to +45 cm H2O (-5 to +45 hPa)
Flow sensor: Internally located at device inlet, digital mass flow type, -70
to +180 L/min
Maximum single fault steady pressure
Device will shut down in the presence of a single fault if the steady state pressure exceeds:
30 cm H2O (30 hPa) for more than 6 sec or 40 cm H2O (40 hPa) for more than 1 sec.
Sound
Pressure level measured according to EN ISO 17510-1:2009 (CPAP mode):
SlimLine: 26.6 dBA with uncertainty of 2 dBA
Standard: 26.6 dBA with uncertainty of 2 dBA
Power level measured according to EN ISO 17510-1:2009 (CPAP mode):
SlimLine: 34.6 dBA with uncertainty of 2 dBA
Standard: 34.6 dBA with uncertainty of 2 dBA
Declared dual-number noise emission values in accordance with ISO 4871:1996.
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Physical - device
Dimensions (H x W x D): 116 mm x 205 mm x 150 mm
Air outlet (complies with ISO 5356-1:2004): 22 mm
Weight: 1106 g
Housing construction: Flame retardant engineering thermoplastic
Temperature
Maximum heater plate: 68°C
Cut-out: 74°C
Maximum gas temperature: 41°C
Air filter
Standard: Material: Polyester non woven fibre
Average arrestance: >75% for ~7 micron dust
Hypoallergenic: Material: Acrylic and polypropylene fibres in a polypropylene
carrier
Efficiency: >98% for ~7-8 micron dust; >80% for ~0.5 micron
dust
Aircraft use
ResMed confirms that device meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21,
category M) for all phases of air travel.
Operating pressure range
APAP, CPAP: 4 to 20 cm H2O (4 to 20 hPa)
Supplemental oxygen
Maximum flow: 4 L/min
Pneumatic flow path
1. Flow sensor
2. Blower
3. Pressure sensor
4. Mask
5. Air tubing
6. Side cover
7. Device
8. Inlet filter
Design life
Device, power supply unit: 5 years
Cleanable humidifier: 2.5 years
Air tubing: 6 months
General
The patient is an intended operator.
Air tubing
Air tubing Material Length Inner diameter
SlimLine Flexible plastic 1.8 m 15 mm
Standard Flexible plastic 2m 19 mm
Notes:
The manufacturer reserves the right to change these specifications without notice.
Do not use electrically conductive or antistatic air tubing.
The temperature and relative humidity settings displayed are not measured values.
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Displayed values
Value Range Display resolution
Pressure sensor at air outlet:
Mask pressure 4–20 cm H2O (4–20 hPa) 0.1 cm H2O (0.1 hPa)
Flow derived values:
Leak 0–120 L/min 1 L/min
Value Accuracy
Pressure measurement1:
Mask pressure2 ±[0.5 cm H20 (0.5 hPa) + 4% of measured value]
Flow and flow derived values1:
Flow ±6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow
Leak2 ±12 L/min or 20% of reading, whichever is greater, 0 to 60 L/min
1
Results are expressed at ATPD (Ambient Temperature and Pressure, Dry).
2
Accuracy may be reduced by the presence of leaks and supplemental oxygen.
Pressure accuracy
Maximum static pressure variation at 10 cm H2O (10 hPa) according to EN ISO 17510-1:2009
Standard air tubing SlimLine air tubing
Without humidification ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.5 hPa)
With humidification ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.5 hPa)
Maximum dynamic pressure variation according to EN ISO 17510-1:2009
Device without humidification and Standard air tubing / Device with humidification and Standard air tubing
Pressure [cm H2O (hPa)] 10 BPM 15 BPM 20 BPM
4 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
8 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
12 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
16 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
20 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
Device without humidification and SlimLine air tubing / Device with humidification and SlimLine air tubing
Pressure [cm H2O (hPa)] 10 BPM 15 BPM 20 BPM
4 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
8 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
12 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
16 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
20 0.5 / 0.5 0.5 / 0.5 0.8 / 0.8
Symbols
The following symbols may appear on the product or packaging.
Read instructions before use. Indicates a warning or caution. Follow instructions before
use. Manufacturer. European Authorised Representative. Batch code.
Catalogue number. Serial number. Device number. On / Off. Device weight.
Protected against finger sized objects and against dripping water when tilted up to 15 degrees
from specified orientation. Direct current. Type BF applied part. Class II equipment.
Humidity limitation. Temperature limitation. China pollution control logo 1. China
pollution control logo 2.
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Prescription only (In the US, Federal law restricts these devices to sale by or on the order
of a physician). Maximum water level. Use distilled water only. Operating
altitude. Atmospheric pressure limitation. Complies with RTCA DO-160 section 21,
category M.
Environmental information
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 www.resmed.com/environment.
Servicing
The AirStart 10 device is intended to provide safe and reliable operation when operated in
accordance with the instructions provided by ResMed. ResMed recommends that the AirStart 10
device be inspected and serviced by an authorised ResMed Service Centre if there is any sign of
wear or concern with device function. Otherwise, service and inspection of the products generally
should not be required during their design life.
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.
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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 organisation that has
not been expressly authorised by ResMed to perform such repairs; c) any damage or contamination
due to cigarette, pipe, cigar or other smoke; and d) any damage caused 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.
Further information
If you have any questions or require additional information on how to use the device, contact your
care provider.
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ResMed Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
See www.resmed.com for other ResMed locations worldwide. For patent and other intellectual property information,
see www.resmed.com/ip. Air10, AirStart, HumidAir and SlimLine are trademarks of ResMed Ltd. SlimLine is registered
in U.S. Patent and Trademark Office. SD Logo is a trademark of SD-3C, LLC. © 2017 ResMed Ltd. 378143/3 2017-11
ResMed.com
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