ResMed ApneaLink User manual

Clinical Guide
English
ApneaLinkAir
ApneaLink Plus

Content
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for use 1
Contraindications 1
General warnings and cautions 1
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Device 4
Assembling the ApneaLink Air system . . . . . . . . . . . . . . . . . . . . . 5
Inserting the batteries 5
Putting the device on the belt 6
Connecting the accessories to the device 6
Fitting the belt 8
Fitting the accessories 9
Using the ApneaLink Air device . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Starting the test 13
Stopping the test - check if test complete 14
Disassembly 15
Using the ApneaLink software application . . . . . . . . . . . . . . . . . 16
Starting the program 16
Preparing a recording 16
Downloading data from the device 18
User interface and software features 19
Database 23
Signal view 24
Report view 40
File transfer 47
Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cleaning 53
Disinfection 54
Maintenance 54
Servicing 54
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Device 55
Program 56
Analysis 58
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
System requirements 60
Device, pulse oximeter and effort sensor 60
Symbols 62
Disposal 63
Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

1Introduction
a. 9
Introduction
Indications for 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
The following are general warnings and cautions. Further specific warnings,
cautions and notes appear next to the relevant instruction in the manual.
WARNING
A warning alerts you to possible injury.
Do not set up the ApneaLink Air system while it is attached to a personal
computer via USB.
CAUTION
A caution explains special measures for the safe and effective use of the device.
•The ApneaLink Air should only be used with accessories recommended
by ResMed. Connection of other accessories could result in injury, or
damage to the device.
•Additional equipment connected to medical electrical equipment must
comply with the respective IEC or ISO standards (eg, IEC 60950 for data
processing equipment). Furthermore all configurations shall comply
with the requirements for medical electrical systems (see IEC 60601-1
clause 16 of the 3Ed.). Anybody connecting additional equipment to
medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements
for medical electrical systems. Attention is drawn to the fact that local
laws take priority over the above mentioned requirements. If in doubt,
consult your local representative or the technical service department.
•Depending on their skin condition or general state of health, patients
will have different levels of sensitivity to materials used in the
ApneaLink Air accessories. If the patient experiences an allergic reaction
use of the system should be discontinued.

2
•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.
•Accuracy of automatic analysis for patients with breaths per minute
higher than 30 bpm cannot be assured.
•In the US, Federal law restricts this system to sale by or on the order of a
physician.
Note:
A note advises of special product features.
•Read the entire manual before using the ApneaLink Air system.
•When using consumables and accessories, please read the manufacturer’s
information supplied with the products.
•Only use the nasal cannula or disposable oximeter finger sensor from their
original packages. If the packaging is damaged, the respective product must
not be used, and should be disposed of along with the packaging.
•ApneaLink Air is now supported by EasyCare Online in some regions. To find
out whether this service is available in your region contact your local
ResMed Customer service. If the service is available in your region and you
require assistance in configuring your ApneaLink software with EasyCare
Online, please contact your local ResMed Technical Service.

3Equipment
Equipment
The ApneaLink Air system includes:
*This item may only be available as accessory in some countries.
Delivery schedule ApneaLink Air basic set
•ApneaLink Air device
•Nasal cannula
•Belt
•USB cable
•Installation and driver CD
•2 luer-lock caps, ventilated for nasal cannula and effort sensor connection
•2 batteries, 1.5 V
•Carry bag
Delivery schedule ApneaLink Air complete set:
•ApneaLink Air device
•3 nasal cannulas
•ApneaLink Air oximetry accessories:
Nonin Xpod®Oximeter Type 3012
Nonin reusable finger pulse sensor Type 8000 SM
Clip fastener for Nonin Xpod
•Belt
•USB cable
•Installation and driver CD
•2 luer-lock caps, ventilated for nasal cannula and effort sensor connection
•2 batteries, 1.5 V
•Carry bag
•Effort sensor
1ApneaLink Air device 5Oximeter*
2Effort sensor 6
Disposable oximeter finger sensor*
3Belt 7Reusable oximeter finger sensor*
4Oximeter belt clip* 8Nasal cannula
9Bag (not shown)
1
2
3
4
5
678
NONIN
NONIN
Xpod
NONIN
Testcomplete

4
Delivery schedule for consumables and accessories:
•Westmed ApneaLink Air Cannula (carton with 25 pieces)
•Nonin disposable finger pulse sensor, Type 7000A (carton with 24 pieces)
•ApneaLink Air accessories for oximetry (Nonin Xpod Oximeter Type 3012 for
ApneaLink Air, Nonin disposable finger pulse sensor Type 7000A, clip
fastener for Nonin Xpod)
•Nonin Flex finger pulse sensor for multiple use, Type 8000J
•Attachment plaster Type 8000JFW for Flex finger pulse sensor (25 pieces)
•Nonin Clip finger pulse sensor for multiple use, Type 8000AA
•Replacement Effort Sensor
Device
The ApneaLink Air device has the following lights, connectors and button:
The “test complete” light simply shows whether or not the test is done. The
ApneaLink Air device considers the test done with the evaluation time of the
flow or the flow and oximetry analysis. The evaluation time can be set in the
software. A green light shows that the test is done. A red light shows that the
test must be repeated. The evaluation time is the recorded time excluding
artefacts, signal too small periods, the start of evaluation event (in general first
10 minutes of recording) and the end of evaluation event (in general last 2
minutes). If there are several recordings on the device, the green “test
complete” light shows that there is at least one complete recording on the
device.
1Test complete light 4
Oximeter connector and accessory light
2Nasal cannula connector and
accessory light
5Effort sensor connector and accessory
light
3Power button
Test complete
1
2
34
5

5Assembling the ApneaLink Air system
Assembling the ApneaLink Air system
CAUTION
•Before assembling the ApneaLink Air system it is important to inspect
the condition of the device and all the accessories. If there are any
visible defects, the device should not be used.
•When the device is not in use, you should always screw on the
ventilated protective caps supplied. Do not use any other caps.
•The nasal cannula and the disposable oximeter finger sensor are
intended for single use only, and must be disposed of after use.
•Do not reuse single use sensors to prevent the risk of cross
contamination.
Notes:
•The physician or healthcare provider is responsible for explaining to the
patient the functions of the ApneaLink Air system and how to operate it
safely with the help of the Patient Instruction and the Clinical Guide.
•To ensure that recording results are accurate, only equipment recommended
for the ApneaLink Air should be used (see “Equipment” on page 3). The
equipment must not be modified.
•Use of the pulse oximeter with the oximeter finger sensor is optional. Pulse
oximetry measurement results are not included in the risk indicator
calculation. These will be shown separately on the report.
Inserting the batteries
The battery compartment is located at the back of the device. Insert the batteries
in accordance with the instructions printed inside the device.
Insert freshly charged batteries or new batteries into the device before each
recording. Use only the specified types of battery or rechargeable battery:
•Two NiMH rechargeable batteries (Micro/AAA/HR03/1.2 V/min. 1000 mAh) or
•Two batteries (Micro/AAA/LR03/1.5 V/min. 1000 mAh).
Notes:
•Fresh, fully charged batteries will last approximately 10 hours while recording.
•When the device is not in use, remove the batteries from the device to
prevent the possibility of damage from leaking battery fluid.
•Store batteries according to the manufacturer‘s specification.
•The batteries in the initial package may be reduced in capacity due to
uncertain transport conditions.

6
Putting the device on the belt
Connecting the accessories to the device
CAUTION
The recorder’s pressure sensors are highly sensitive. For this reason, you
should never blow directly into the connections for the nasal cannula or the
effort sensor.
The accessories may already be attached to the device. If they are not attached,
connect them as shown.
Remove the ventilated protective caps from the nasal cannula and effort sensor
connections. Keep the protective cap for further use.
1. Thread one end of the belt through
the slots on the back of the device.
Check that the device is positioned
as shown.
2. Flip the device over. Thread the end
of the belt closest to the device
through one of the slots on the
effort sensor.
3. Fasten the tab to the belt. Slide the
device into a position that is close to
the effort sensor.
12
Testcomplete
3

7Assembling the ApneaLink Air system
Connecting the nasal cannula and the effort sensor
Connecting the oximeter
1. Insert the connector end of the
nasal cannula into the nasal cannula
connector on the device. Turn
clockwise until the connector is
secure.
2. Insert the connector end of the
effort sensor into the effort sensor
connector on the device. Turn
clockwise until the connector is
secure.
Testcomplete
Testcomplete
12
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.
Model 3012
S/N
501392587
0123
Nonin Medical. Inc. Patent # Re 33,643
www.resmed.com
NINON
Xpod
NONIN
12
R
Testcomplete
NONIN
Testcomplete
3

8
Fitting the belt
CAUTION
To avoid irritation or allergic reactions, wear the belt and device over a long-
sleeved shirt.
Notes:
•The easiest way to put on the device is while standing in front of a mirror.
•For women, the belt should be worn above the breasts.
•Do not overtighten the belt as this would reduce signal quality and reduce
patient’s comfort. The belt should be secure and comfortable.
The ApneaLink Air respiratory effort sensor is proprietary ResMed technology
using a simple pneumatic technology. The tube inside the effort sensor gets
deformed by pulling the belt. This volume change results in a pressure change
which gets recorded by the pressure sensor. It has been tested and found
comparable in accuracy to RIP technology.
1. Pull the belt around the body. Thread
the free end of the belt through the
free slot on the effort sensor and
fasten the tab to the belt.
2. Check that the belt is secure and
comfortable and that the device is
positioned over the centre of the
chest.
3. If using an oximeter, slide the clip
onto the belt. The clip should be
worn on the same side of the body
as the oximeter finger sensor.
Testcomplete
12
3

9Assembling the ApneaLink Air system
Fitting the accessories
CAUTION
If the patient develops redness, irritation or a rash from the nasal cannula or
oximeter finger sensor, it might be an allergic reaction. Advice the patient
to discontinue use.
Nasal cannula
WARNING
Ensure that the cannula is fitted as described so as not to pose a
strangulation risk.
Note: If the nasal cannula does not stay in the nose, use medical tape or
adhesive bandages on the cheeks to hold it in place.
1. Insert the prongs into the nostrils.
Make sure the curved side is pointing
towards the back of the nose.
2. Loop the plastic tubing around the
ears.
3. Pull the slider up towards the chin
until the plastic tubing is secure and
comfortable.
12
3

10
Oximeter finger sensor
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.
•The pulse oximeter module is designed to determine the percentage of
arterial oxygen saturation of functional hemoglobin. Significant levels of
dysfunctional hemoglobin, such as methemoglobin, might affect the
accuracy of the measurement. Factors that may degrade pulse oximeter
performance or affect the accuracy of the measurement include the
following: excessive ambient light, excessive motion, electrosurgical
interference, blood flow restrictors (arterial catheters, blood pressure
cuffs, infusing lines, etc.), moisture in the sensor, improperly applied
sensor, incorrect sensor type, poor pulse quality, venous pulsations,
anemia or low hemoglobin concentrations, cardiogreen or other
intravascular dyes, carboxyhemoglobin, methemoglobin, dysfunctional
hemoglobin, artificial nails, fingernail polish, or a sensor not at chest
level.
•Loss of monitoring can result if any objects hinder the pulse
measurement. Ensure that no blood flow restrictors (e.g., blood
pressure cuff) hinder pulse measurements.
•Operation of the oximeter below the minimum amplitude of 0.3%
modulation may cause inaccurate results.
CAUTION
•The oximeter has motion tolerant software that minimizes the likelihood
of motion artifact being misinterpreted as good pulse quality. In some
circumstances, however, this device may still interpret motion as good
pulse quality. This covers all available outputs (ie, SpO2, HR).
•The oximeter sensor may not work on cold extremities due to reduced
circulation. Warm or rub the finger to increase circulation, or reposition
the sensor.
Notes:
•The finger symbol on the adhesive strip shows the position in which the
adhesive tape should be attached to the finger.
•This connection is a press-fit (in-out) connection. Do not twist the oximeter
cable when connecting to, or disconnecting from, the device.
Attach the oximeter finger sensor to the fourth finger of the right hand using the
self-adhesive strip.
The clinical guide covers the NONIN disposable oximeter finger sensor. For other
finger sensors, refer to the instructions in the packaging.

11Assembling the ApneaLink Air system
Disposable oximeter finger sensor
Note: If the oximeter finger sensor is uncomfortable, you can move it to a
different finger or the other hand.
1. Remove the backing from the
sensor.
2. Place the sensor over the fourth
finger on the non-dominant hand.
Line up the picture of the fingernail
on the oximeter finger sensor with
the patient‘s fingernail.
3. Fold the tabs around the sides of
the finger.
4. Fold the top flap under the finger
and wrap it around the finger.
5. The sensor should be positioned as
shown.
12
34
5

12
Reusable oximeter finger sensor
Note: If the oximeter finger sensor is uncomfortable, you can move it to a
different finger or the other hand.
To fit the reusable finger sensor, slip it
over the fourth finger on the non-
dominant hand as shown.

13Using the ApneaLink Air device
Using the ApneaLink Air device
Starting the test
Note: All indicator lights will dim (but stay lit) approximately 10 minutes after
recording begins.
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.
Testcomplete
Testcomplete
Test complete
12

14
Stopping the test - check if test complete
Notes:
•To re-check the test complete light, press the power button until the light
turns on (about three seconds), then press the power button again for about
three seconds.
•To replace the batteries, open the battery cover on the back of the device and
insert two new batteries.
1. Press the power button for about
three seconds.
2. Check that the test complete light is
lit and green. This means the test is
complete. If the test complete 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.
Test complete
Test complete
12
Testcomplete
3

15Using the ApneaLink Air device
Disassembly
After recording, the patient must do the following:
1. Remove the belt from the body.
2. Remove all the connectors from the device.
3. Screw the protective caps back on the effort sensor and nasal cannula
connector.
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).
7. Place everything else back in the bag and return it to the physician or
healthcare provider as requested.
The physician/HCP must do the following:
•Clean device and multiuse sensors.
•Disinfection (if necessary).

16
Using the ApneaLink software application
Starting the program
After installing the ApneaLink software the first time, a shortcut is created
on the desktop. Double-click to run the program.
Preparing a recording
1. Connect the device to the computer.
2. Run the ApneaLink program.
3. In the Quick Start window click Prepare ApneaLink .
The Patient Information window appears.
4. If the patient’s personal detail is known, complete the patient record card.
Note: If the patient data has already been recorded, you can open a selection
list using the Select patient button to show the names of previous patients.
Select the patient required to display the patient’s record card.
5. If the patient’s detail is unknown or these are not to be entered initially click
Anonymous Patient.
In this case, the patient’s details must be recorded later when the recording
is downloaded from the device.
6. Set the evaluation time for the test complete by clicking the left mouse
button and dragging the pointer to either left or right (see also “Default
device configuration” on page 17).
7. Click OK.

17Using the ApneaLink software application
Notes:
•A dialog box will appear to warn you when preparing a device that still
contains recorded material. You can use the dialog box to continue
customization or download recordings from the device. Recordings that are
not downloaded, together with the associated patient data, are deleted by
the customization process.
•The physician is responsible to instruct the patient with the patient
instructions and to give it to the patient to take home.
•If you are using several devices, we advise you to mark the device with the
name of the patient after customization (eg, by attaching an adhesive label to
the device sticker to prevent confusion when assigning a recording).
•If the fields Referred by doctor, History and Comments are completed when
the recording is prepared, these will only be available in the patient record
card if the download is performed on the same computer. The contents of
the Comments field will appear on the report.
Default device configuration
In the tools menu you can change the default settings for the test complete.
1. Click on To o l s > Settings > Device configuration.
2. Set the default value for the recording channels.
3. Set the default value for a sufficient analysis time.
Faulty device status
When a device gets prepared for a recording a faulty device status is indicated
by a continuous red light in the patient information dialog. In this situation, it is
not possible to customize the device. The following table describes error
messages displayed in the software:
.
Click Update once the error has been corrected. The updated device status is
then displayed.
Error Message Action
Device not connected •Check the USB connection between device and computer.
•Check that the driver files in the Windows device manager
have been correctly installed.
•Contact ResMed or an authorized ResMed distributor if the
problems continue.
Battery voltage too low Replace the batteries or rechargeable batteries in the device.
Required battery voltage: at least 2.4 V (2 x 1.2 V).
No battery •Check that batteries/rechargeable batteries have been placed
in the device.
•If the device does contain batteries or rechargeable batteries,
check correct pole (+/-) alignment.

18
Downloading data from the device
1. Plug the USB cable into the mini USB connector on the device and into an
available USB port of your computer.
2. Run the ApneaLink program.
3. Click Download ApneaLink .
Notes:
•If the device was not allocated to a patient during customisation, the
download procedure is interrupted and a patient record card appears.
•Data transfer and analysis are complete when the report is displayed.
•Each recording needs up to 15 MB free computer hard disk space. Before
downloading, ensure there is enough space available. The available space is
displayed in the status bar of the ApneaLink program.
•The download procedure may take up to five minutes.
•Recordings shorter than ten seconds are not stored.
•For recordings with less than 60 minutes of valid data, the analysis time is
considered too short for performing a reliable screening result. A note is
posted on the report: “Attention: Evaluation period too short!“. Any data that
is captured by the device can be manually scored.
•If there are several recordings on the device, all the recordings are
downloaded and analysed, and a report is produced for each. The report for
the longest recording is displayed automatically. The other recordings and
reports are also available in the database. All recordings that are transferred
during a download have the same patient data.
•If the data has been downloaded successfully, both the recording and the
patient data in the device are deleted automatically.