ResMed ApneaLink User manual

1
ApneaLinkAir
ApneaLink Plus
Introduction
Your physician or healthcare provider has given you the ApneaLink Air device to test if you have sleep-disordered breathing. The device
collects information related to how much and how well you breathe at night. Read these instructions thoroughly before you begin your
test.
Intended use
The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered
breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation,
pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis
of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of
a HCP.
Contraindications
• The ApneaLink Air system must not be used in the vicinity of an MRI device.
• Explosive Hazard: Do not use the ApneaLink Air system in an explosive atmosphere or in the presence of flammable anesthetics or
gases.
General warnings and cautions
WARNING
Do not use the system if any of the accessories are ripped, broken or bent or if the housing of the ApneaLink Air device is
broken.
CAUTION
•In the US, Federal law restricts this system to sale by or on the order of a physician.
•Do not set up the ApneaLink Air system while it is attached to a personal computer via USB.
Patient
Instructions
English
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2
Equipment
The ApneaLink Air system includes:
1ApneaLink Air device 6Disposable oximeter finger sensor (optional)
2Effort sensor (optional) 7Reusable oximeter finger sensor (optional)
3Belt 8Nasal cannula
4Oximeter belt clip (optional) 9Bag (not shown)
5Oximeter (optional)
NONIN
Xpod
NONIN
Test complete
34
1
7
2
8
56
ApneaLink Air interface
The ApneaLink Air device has the following lights, connectors and button:
1Test complete indicator light 4Oximeter connector and accessory light
2Nasal cannula connector and accessory light 5Effort sensor connector and accessory light
3Power button
Test complete
1
2
3
4
5
Putting the device on the belt
Before putting the device on the belt, ensure that the batteries are installed. To install the batteries, open the battery cover on the back of
the device and insert two new AAA batteries.
1
1. Thread one end of the belt
through the slots on the
back of the device. Check
that the device is positioned
as shown.
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3
Follow these steps if you are using the effort sensor:
Test complete
2
Test complete
3
2. Flip the device over. Thread the end of the belt closest to the
device through one of the slots on the effort sensor (if used).
3. Fasten the tab to the belt.
Slide the device into a
position that is close to the
effort sensor.
Connecting the accessories to the device
CAUTION
Do not blow into the nasal cannula or effort sensor connectors.
The accessories may already be attached to the device. If they are not attached, connect them as shown.
Connecting the nasal cannula
Testcomplete
Unscrew and remove the protective cap and insert the connector
end of the nasal cannula into the nasal cannula connector on the
device. Turn clockwise until the connector is secure.
Note: Retain the protective caps to use at the completion of the
test.
Connecting the effort sensor (if used)
Testcomplete
Unscrew and remove the protective cap and insert the connector
end of the effort sensor into the effort sensor connector on the
device. Turn clockwise until the connector is secure.
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4
Connecting the oximeter (if used)
NONIN
1
Model 3012
S/N
501392587
0123
Nonin Medical. Inc. Patent # Re 33,643
www.resmed.com
2
R
Testcomplete
3
1. Attach the oximeter finger
sensor to the oximeter.
2. Attach the belt clip to the
oximeter.
3. Attach the oximeter to the oximeter connector on the device by
pushing it on.
Fitting the belt
CAUTION
To avoid irritation or allergic reactions, wear the belt and device over a long-sleeved shirt.
1
Testcomplete
2
3
1. Pull the belt around your
body. Thread the end of the
belt through the slot on the
effort sensor (if used) and
fasten the tab to the belt. If
you are not using the effort
sensor, attach the tab to the
belt.
2. Check that the belt is secure
and comfortable and that
the device is positioned over
the centre of your chest.
3. If using an oximeter, slide
the clip onto the belt. The
clip should be worn on the
same side of your body as
the oximeter finger sensor.
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5
Fitting the accessories
CAUTION
If you develop redness, irritation or a rash from the nasal cannula or finger sensor, discontinue use and contact your healthcare
provider or physician.You may be having an allergic reaction.
Nasal cannula
WARNING
Ensure that the cannula is fitted as described so as not to pose a strangulation risk.
1
2
3
1. Insert the prongs into your nostrils.
Make sure the curved side is pointing
towards the back of your nose.
2. Loop the plastic tubing
around your ears.
3. Pull the slider up towards your chin until the
plastic tubing is secure and comfortable.
Note: If the nasal cannula does not stay in your nose, use medical tape or adhesive bandages on your cheeks to hold it in place.
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6
Disposable finger sensor (if used)
WARNING
Ensure that the oximeter clip is positioned on the same side of the body as the finger sensor so as not to pose a strangulation
risk.
1
2
3
4
1. Remove the backing from
the sensor.
2. Place the sensor over the
fourth finger on your non-
dominant hand. Line up the
picture of the fingernail on
the finger sensor with your
own fingernail.
3. Fold the tabs around the
sides of your finger.
4. Fold the top flap under your
finger and wrap it around
your finger.
5
5. The sensor should be
positioned as shown.
Note: If the finger sensor is uncomfortable, you can move it to a different finger or your other hand.
Reusable finger sensor (if used)
WARNING
Ensure that the oximeter clip is positioned on the same side of the body as the finger sensor so as not to pose a strangulation
risk.
1. To fit the reusable finger
sensor, slip it over the index
finger on your non-dominant
hand as shown.
Note: If the finger sensor is uncomfortable, you can move it to a different finger or your other hand.
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7
Starting the test
R
Testcomplete
Test complete
1
Testcomplete
2
When properly set up, the full
system looks like this.
1. Press and hold the power
button in the centre of
the device for about three
seconds or until the light
turns on.
2. Check that lights next to the
accessories you are using
are green. If any of these
lights are red and blinking,
the accessories are not
attached correctly.
Once you have started the test, go to sleep as normal. The lights on the device will dim after 10 minutes. If you have to get up during the
night for any reason, leave the device on unless you do not intend to go back to sleep. You can remove the oximeter finger sensor if you
need to go to the bathroom or wash your hands. Replace the oximeter finger sensor before going back to sleep.
Stopping the test - check if test complete
Test complete
1
Test complete
2
Test complete
3
1. Press the power button for
about three seconds.
2. Check that the test
complete indicator light is lit
and green. This means the
test is complete. If the test
indicator light is red, replace
the batteries and repeat the
test tomorrow night.
3. Press and hold the power
button for about three
seconds to turn off the
device.
Note:
• To re-check the test complete indicator light, press the power button until the light turns on (about three seconds), then briefly press
the power button again.
• To replace the batteries, open the battery cover on the back of the device and insert two new AAA batteries.
• The device does not need any servicing or maintenance before recording.
Disassembling and returning the device
When the test is completed:
1. Remove the belt from your body.
2. Remove all the connectors from the device.
3. Screw the protective caps back on the effort sensor and nasal cannula connectors.
4. Disconnect the finger sensor from the oximeter.
5. Remove the device from the belt.
6. Throw away the nasal cannula and the disposable finger sensor (see the Equipment section on the first page).
7. Place everything else back in the bag and return it to your physician or healthcare provider as requested.
Do not attempt to clean the device.
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Manufacturer: ResMed Germany Inc. Fraunhoferstr. 16 82152 Martinsried Germany. Distributed by: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA. See www.resmed.com for other ResMed locations worldwide.
For patent information, see www.resmed.com/ip. ApneaLink is a trademark of ResMed R&D Germany GmbH and is registered in U.S. Patent and Trademark Office.
© 2013 ResMed Ltd. 228691/1 2013-10
Troubleshooting
Problem/Possible cause Possible solution
The test complete indicator light doesn’t turn on when I press the power button
The batteries are depleted. Replace the batteries by opening the battery cover and inserting
two new AAA batteries.
The device is faulty. If the light does not turn on after replacing the batteries, return the
device to your physician or healthcare provider.
One of the accessory lights is red after I begin the test
The accessory hasn’t been connected correctly. Leave the device turned on and reconnect the accessory according
to the instructions. If using the oximeter, reconnect the finger
sensor to the oximeter. Check that the light has turned green.
The accessory is not fitted correctly. Leave the device turned on and refit the accessory according to the
instructions. Check that the light has turned green.
The accessory or device is faulty. If you cannot get the light to turn green, return the device and
accessories to your physician or healthcare provider.
All of the lights (including the test complete indicator light) are red and blinking when I turn the device on
The device is faulty. Return the device to your physician or healthcare provider.
The effort accessory light is red and blinking when I wake up the morning
The effort sensor became disconnected during the night. Replace the batteries and use the device again tomorrow night.
One of the other accessory lights is red and blinking when I wake up in the morning
One of the other accessories became disconnected during the night. Check the test complete indicator light as described in Stopping the
test. If the light is green, the test was successful. If the light is red,
replace the batteries and use the device again tomorrow night.
The test complete indicator light is red when I turn off the device in the morning
The device did not gather enough data. Replace the batteries and use the device again tomorrow night.
The test complete indicator light is off when I turn off the device in the morning
The batteries became depleted during the night. Replace the batteries and use the device again tomorrow night.
Electromagnetic compatibility
The ApneaLink Air complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for
residential, commercial, and light industry environments. Wireless communications equipment such as wireless home network device,
mobile phones, cordless telephones and their base stations, walkie-talkies can affect the device and should be kept at least a distance
d away from the device. As example the distance d for a typical mobile phone with a maximum output power of 2 W would be 10‘ 8“
(3.3m).
For further details, see “Electromagnetic Emissions and Immunity” on www.resmed.com on the Products page under Service &
Support. If you do not have internet access, please contact your ResMed representative.
Symbols
IP22
Protected against finger sized objects and against dripping water when tilted up to 15 degrees from specified orientation.
Global leaders in sleep and respiratory medicine
www.resmed.com
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