Respironics Alice PDx User manual

REF 1053638
1049836
JDH 6/27/08

© 2008 Respironics, Inc. and its aliates. All rights reserved.
All information contained in this document is subject to change without notice. Respironics
reserves the right to make changes to equipment design or program components, as progress in
engineering, manufacturing methods, or other circumstances may warrant.
Alice®, Respironics®, Sleepware® and the Respironics logo are registered trademarks of
Respironics, Inc. Patents pending.
All other trademarks are owned by their respective companies.

Provider Guide
Table of Contents
Chapter 1 1 Introduction
1 Intended Use
2 Warnings & Cautions
2 Warnings
3 Cautions
4 Package Contents
5 Product Support
5 Limited Warranty
5 Applicability of Warranty
6 System Overview
7 Good Study Indicator
8 Symbol and Label Denitions
Chapter 2 11 Software Installation
11 Installing Sleepware
12 Adding an AlicePDx Device to Sleepware ....................................
Chapter 3 13 AlicePDx Device Setup
13 Installing Batteries and SD Memory Card
15 Connecting an AlicePDx Device to a Computer.....................................
AlicePDx
Provider Guide

Alice®PDx™
15 Connecting an AlicePDx Device to a Respironics Therapy Device
17 Connecting an AlicePDx to a Non-Respironics Therapy Device
17 Connecting an SD Card Reader to a Computer
Chapter 4 19 Preparing for a Sleep Study Acquisition
19 Overview
22 Patient Setup (Attaching Sensors)
22 Attaching Basic Set of Sensors
25 Attaching Optional ECG Electrodes
28 Attaching Optional ExG Electrodes
30 Pre-Acquisition Equipment Checks
31 Recording Patient Events
Chapter 5 33 Performing an Acquisition
33 Starting a Real-Time Acquisition
34 Stopping a Real-Time Acquisition
34 Importing Acquisition Data from an SD Memory Card..
Chapter 6 35 Cleaning and Maintenance
35 AlicePDx Device and Holster
35 Carrying Case
35 Lanyard
35 Sensors
36 ExG
36 ECG
36 Cannula and Thermistor Sensors
36 Eort Belts
36 Maintenance

Provider Guide
Chapter 7 37 Troubleshooting
Chapter 8 39 Specications
39 AlicePDx Device
39 Size
39 Classications and Standards Compliance
39 Power Requirements
40 AlicePDx Temperature and Storage Information ................
40 SpO2 Sensors
40 Disposal
Appendix A 41 Glossary
Appendix B 43 EMC Information
Appendix C 47 Understanding Channels
Index 51

Alice®PDx™

Provider Guide
1
AlicePDx is a portable, diagnostic recording device. It may be used for obstructive sleep apnea
screening as well as for follow-up and diagnostic assessment. The device may be used in a sleep lab
or clinical setting by trained professionals, and it may be used at home by patients as directed by
their healthcare provider.
The AlicePDx device is capable of recording various physiologic inputs and storing the data locally
on the removable storage card. The device may also be connected directly to a computer running
the Sleepware software application. Sleepware can display live or pre-recorded data in a resolution
consistent with the computer hardware specications.
Intended Use
The AlicePDx is a multi-function recording device that collects and stores physiological signals. The
recorded data is downloaded, presented graphically on a computer screen, and may be printed
for diagnostic review by clinicians/physicians to aid in the diagnosis of respiratory sleep disorders
or other physiological disorders. The AlicePDx may be used on adults in the home or hospital/
institutional environment.
The device does not provide alarms and is not intended for use as an automated apnea or
cardiac monitor.
AlicePDx
Provider Guide
1. Introduction

Alice®PDx™
2
Warnings and Cautions
CAUTION
U.S. federal law restricts this device to sale by or on the order of a licensed healthcare professional. This
product should be used only under the supervision of a physician.
Warnings
The following warnings indicate the possibility of injury to the user or the operator.
• Consultwiththepatient’sphysicianpriortoperformingthestudywhenapatienthasacardiac
pacemaker.
• Removeallpatientcables(appliedparts)beforeperformingcardiacdebrillation.TheAlicePDx
device and its accessories are not protected against the eect of cardiac debrillation.
• DonotusetheAlicePDxdeviceinaMagneticResonanceImaging(MRI)environmentorin
close proximity to a high emissions source.
• Donotuseduringhighfrequencysurgicalproceduresorelectrosurgery.
• TheAlicePDx system and software are not designed to replace the clinical judgement and
analysis of a healthcare professional.
• Donotplugsensorcablesintoelectricaloutlets.Cablecontactwithelectricaloutletspresentsa
serious shock hazard.
• Makesuretheconductivepartsofelectrodesandassociatedconnectors,includingtheneutral
electrode, do not contact other conductive parts, including earth.
• Oxygensupportscombustion.Oxygenshouldnotbeusedwhilesmokingorinthepresenceof
an open ame.
• Donotusethedeviceinthepresenceofaammableanaestheticmixtureincombinationwith
oxygen or air, or in the presence of nitrous oxide.
• Verifyallsensorsareworkingproperlypriortouse.
• When attaching the sensors and cables, be careful to route the cables in a manner that will
reduce the possibility of strangulation, discomfort, or the sensors becoming detached.
• Periodicallyinspectthesensorcablesfordamageorsignsofwear.Discontinueuseandreplace
if damaged.
• Ifyounoticeanyunexplainedchangesintheperformanceofthisdevice,ifthedeviceis
dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken,
discontinue use and contact Respironics for assistance.
• RepairsandadjustmentsmustbeperformedbyRespironics-authorizedservicepersonnelonly.
Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
• Use caution when removing damaged batteries and avoid exposing skin to any
battery leakage.
• Recycleordisposeofbatteriesinaccordancewithlocalregulations.Donotincinerate.

Provider Guide
3
• UseonlyaccessoriesthathavebeenapprovedbyRespironics.
• ConnectingtheAlicePDx to a device that is not approved by Respironics with the therapy and/
or Sleeplink communication cables, may result in a shock hazard to patient. Only devices that
are IEC 60601-1 approved may be attached to the AlicePDx.
• Ensure that any computer connected to the AlicePDx complies with the safety standard IEC
60950. Only connect the AlicePDx to an IEC 60950 compliant computer when conguring
the device or when viewing a sleep study in real time, carefully following the respective
instructions.DonotconnecttheAlicePDx to any other USB compatible device.
Cautions
The following cautions indicate the possibility of damage to the device.
• Followallofthemanufacturer’srecommendationsandinstructionsfortheAlicePDx and all
equipment used with the device.
• OperationoftheAlicePDx device may be adversely aected by:
 • electromagneticeldsexceedingthelevelof10V/minthetestconditionsofEN60601-1-2
 • theoperationofhighfrequency(diathermy)equipment
 • debrillators,orshortwavetherapyequipment
 • radiation(e.g.,x-ray,CT)
 • magneticelds(e.g.,MRI)
• Syntheticfabricfromdraperiesorrugscanalsocauseinterferenceduetostaticelectricity.
Touchinganinanimateobject(e.g.,wall)beforehandlingthesystemoftenpreventsstatic
build-up problems.
• StrongtransmittersignalsfromTV,radio,airport,police,re,andambulancestationscould
be received and may be misinterpreted as heart and/or breath signals. If you are located less
than one mile from any of these sources, ask Respironics Customer Service to assist you in
determining whether your system will operate properly.
• DonotplaceliquidsonorneartheAlicePDx device. If liquids are spilled on the equipment,
discontinue use until it can be determined that the device can be safely operated. Contact
Respironics for assistance.
• DonotimmersetheAlicePDx device in any uids.
• PerformanceoftheAlicePDx cannot be assured when connected to therapy devices not
manufactured by Respironics. Hand scoring of the data must be performed to ensure a correct
diagnosis.
• IfyouuseanExGorEEGNeuroground,donotusetherightleg/groundECG lead.
• Neveruseharshcleaningagentsorchemicals.Neverspraycleanerdirectlyontothedevice.
• Makesureallpartsarethoroughlydrybeforeusing.
• Donotautoclave,gas,orpressuresterilizeAlicePDx equipment.

Alice®PDx™
4
The AlicePDx system contents:
• AlicePDx device
• Deviceholster and lanyard
• Oralthermistor sensor
• Nasalcannula starter pack
• SpO2sensor
• SpO2extension cable
• Chestandabdominaleort belts and associated wire set
• PCcommunication cable
• Fouralkalinebatteries
• RemovableSDdatastoragecard
• SDcardreaderandextensioncable
• Manuals
Optional equipment:
• ECG yoke
• ExG yoke
• ECGandneurologicalelectrodes(forExG)
• Therapydevicecommunication cable with
SmartCard connection
• Therapydevicecommunication cable with serial connection
 (typicallyusedwithventilationdevices)
Package Contents
The AlicePDx device should include the following items. If any of these items are not included,
contact a Respironics representative.
WARNING
Use only accessories that have
been approved by Respironics.

Provider Guide
5
Product Support
If you need product support, call the Respironics Customer Service department at 1-800-345-6443.
You may also send an e-mail to Respironics Customer Service at [email protected].
Limited Warranty
Respironics, Inc. warrants that the AlicePDx device shall be free from defects of workmanship
and materials and will perform in accordance with the product specications for a period of two
years from the date of sale by Respironics, Inc. to the customer. If the product fails to perform in
accordance with the product specications, Respironics, Inc. will pay customary freight charges
from Respironics, Inc. to the customer location only. This warranty does not cover damage caused
by accident, misuse, abuse, alteration and other defects not related to material or workmanship.
Respironics, Inc. disclaims all liability for economic loss, loss of prots, overhead or consequential
damages which may be claimed to arise from any sale or use of this product. Some states do not
allow the exclusion or limitation of incident or consequential damages, so the above limitation or
exclusion may not apply to you.
This warranty is given in lieu of all other express warranties. In addition, any implied warranties—
including any warranty of merchantability or tness for the particular purpose—are limited to one
year. Some states do not allow limitations on how long an implied warranty lasts, so the above
limitation may not apply to you. This warranty gives you specic legal rights, and you may have
other rights that vary from state to state.
To exercise your rights under this warranty, contact Respironics, Inc. at:
United States: Europe:
Respironics, Inc. Respironics Germany
1001 Murry Ridge Lane Gewerbestrasse 17
Murrysville, Pennsylvania 82211 Herrsching, Germany
15668 USA
Telephone: [phone] Telephone: [phone]
Applicability of Warranty
The terms and conditions of this warranty are applicable as between Respironics, Inc. and the
customer as to either a sale of the equipment, or to a transaction whereby Respironics, Inc. sells or
conveys such equipment to a third party for lease to the customer.
The limitations and warranty provision herein shall ensure the benet of Respironics, Inc. and any
manufacturer of the equipment sold by Respironics, Inc.

Alice®PDx™
6
System Overview
The ow of data through the AlicePDx system begins with sensors attached to the patient. The
sensors pick up physiologic signals, such as airow, pulse oximetry, and chest and abdominal eort.
Sensor cables carry the signal to the AlicePDx device. The signals are stored on the removable
memory card, or, if congured to do so, the signals are sent from the AlicePDx device to a computer
running the Alice Sleepware diagnostic application.
The AlicePDx device interface is simple and informative. The color-coded labels found around the
perimeter show where to connect the various sensors. Each sensor connector is color-coded to
correspond to the sensor connection on the device. In addition, the name of the sensor is located
on the adjacent side of the device, as shown in the gure above. The basic sensor set includes the
nasal cannula and/or the oral thermistor, abdominal and chest eort belts, and the SpO2sensor.
Each of the sensors has a corresponding connection indicator on the AlicePDx screen. These
indicators will ash to show which sensors your healthcare provider has programed to be recorded.
Once each connection is made, the indicators will stop ashing to show a good connection.
In addition to the basic channel set indicators, there are also indicators for ECG and ExG yokes.
When the study is congured for ECG and ExG, the respective yoke indicator displays a ashing
connection( )symboluntiltheassociatedyokeispluggedin.Whentheyokeispluggedin,the
indicator stops ashing and turns solid.
Other visual indicators include the Good Study Indicator, the battery and memory card status,
and device-level error. All of the symbols used in the interface are dened in the Symbol and Label
Denitions section.
Basic set of sensors
connected
AlicePDx
E
C
G
E
x
G
P

Provider Guide
7
Oral Thermistor Nasal Cannula
Good Study Indicator
Chest Belt
Abdominal Belt
ExG/Actigraphy
*
Error Indicator
Memory Card Status
Battery Status
ECG
Pulse Oximetry
Communication
Port
COMMUNICATION SpO2ECG
EXG/ACITMETER ABDOMINAL THORACIC
AlicePDx
E
C
G
E
x
G
P
E
x
G
Good Study Indicator
The Good Study Indicator displays how much good quality data is needed for a complete study.
In order to conduct an eective Sleep Apnea study, patient airow and pulse oximetry are the
most important variables. Without either of these signals, the sleep study would be declared
diagnostically invalid for insucient data. The Good Study indicator prevents this from occurring.
The indicator measures both patient airow, gathered by the nasal cannula and/or the oral
thermistor, and pulse oximetry, gathered by the SpO2sensor, and decides if the signals read are true
signals of good quality. Combining these factors with the amount of time allotted for the study,
the Good Study Indicator determines the amount of good quality data gathered and displays the
amount in 25% increments on the AlicePDx display screen.
As a result, the patient can see how much good quality data was gathered after waking and convey
this information to the heathcare provider. Then, the healthcare provider can determine if the
patient needs to repeat the study.
*Actigraphy reserved for future use.
Patient Event
Button
Power Button
AlicePDx device interface
Device buttons

Alice®PDx™
8
Symbol and Label Denitions
Symbols
Symbol Denition Symbol Denition
Consult accompanying
documents TypeBFAppliedPart
Prescription(Rx)only Canadian/US Safety
Certication
Power Button
PatientEventMarker(PEM)
sets an event marker
during recording
Sensor Connection Labels
Symbol Denition Symbol Denition
Label for oral
thermistor connection
P
Label for nasal
cannula connection
Label for chest
belt connection
Label for abdominal
belt connection
E
x
G
Label for ExG /
Actigraphy connection
E
C
G
Label for ECG connection
Label for pulse
oximetry connection
Label for PC and therapy
device connection

Provider Guide
9
Display Icons and Connection Indicators
Symbol Denition Symbol Denition
Indicates good connection
for either the ECG, ExG, or
serial connections
Indicates thermistor(ORAL)
connection
Indicates cannula(NOSE)
connection
Indicateschestbelt(THO)
connection
Indicates abdominal belt
(ABD)connection Indicates SpO2 connection
Indicates a device error
Contact Respironics
for assistance
Indicates sleep study has
not begun or the device has
gathered less that 25% good
quality data needed for a
complete study
Indicates the device has
gathered 25% good quality
data needed for a
complete study
Indicates the device has
gathered 50% good quality
data needed for a
complete study
Indicates the device has
gathered 75% good quality
data needed for a
complete study
Indicates the device has
gathered 100% good quality
data needed for a
complete study
Indicates memory
cardisfull(willash
untilreplaced)
Indicates memory card is
empty,(willashifmissing
orcorrupted)
Indicates battery is empty
Note: Connection symbols will ash when they do not detect a good connection.

Alice®PDx™
10

Provider Guide
11
AlicePDx
Provider Guide
Installing Sleepware
Before installation, please note the following:
1. You must be logged onto the computer as “Administrator.”
2. Ensure that all folders to be used by specic groups and
users have the necessary permissions settings.
3. The permissions on all data locations must be opened
so that all users have read and write access. The software
installer will attempt to do this for the chosen installation
folder.
4. Insert the SleepwareCDintotheCDdriveofyour
computer and follow the on-screen instructions.
5. After installation is complete, create all of the data
locationsneeded(seeSleepware’sonlinehelpfordetails).
As Administrator, change the security rights attached to
anyotherdatalocationsyou’vecreated,toallowallusers
full control of these directories. You can also change the
user type back to “restricted” on the computer if necessary.
2. Software Installation
This chapter provides a brief overview of the software installation. Before you can view waveform
data collected from an AlicePDx device, you must install the Sleepware software on a computer.
Note: For more advanced
functionality, such as Windows
Terminal Services, refer to the
Sleepware online help.
Note: When you change
access permissions on a folder,
Windows prompts you with
a choice of either applying
changes to “this folder only” or
to “this folder, subfolders, and
les.” Choose the second option
to apply changes to all of the
folders/les.

Alice®PDx™
12
Adding an AlicePDx Device to Sleepware
You must add a new AlicePDx device to Sleepware before it can be used:
1. Click on the Congure button on the Sleepware starter bar and select the Add/Modify
Device option from the pop-up menu.
TheAdd/ModifyDevicemenuisdisplayed.
2. Select the AlicePDx option.
The AlicePDxAdd/ModifyDevicewindowisdisplayed.
3. Click the Enable support for AlicePDx check box and enter a Friendly name(anamethat
isrecognizabletoyou)fortheAlicePDx device.
The name you enter will appear on the Sleepware starter bar as a device button.
4. Click OK to complete the device addition.
Refer to Sleepware’sonlinehelpforinstructionsonhowtocongurean AlicePDx device for use
with Sleepware.

Provider Guide
13
AlicePDx
Provider Guide
3. AlicePDx Device Setup
To remove the plastic holster from device:
1. Hold the AlicePDx device in one hand, with the back of
the device facing you.
2. With your opposite hand, place your thumb in the center
of the back and your nger on the small tab on the side of
the device.
3. While pressing down with your thumb, slowly pull back
with your ngers until the tab snaps loose, and the holster
is removed.
This chapter describes how to set up the AlicePDx device for use with a patient.
Installing Batteries and SD Memory Card
The AlicePDxdevicecanbepoweredbythree,1.5V,AA-sizealkalineorthree,1.5V,AA-sizeNiMH
rechargeable batteries. It is highly recommended that fresh batteries be installed prior to use for
each night of a sleep study.
Note: Removing the holster
may be dicult. Use care not
to damage the holster or the
device.
Lift small tab up Lift until holster snaps loose

Alice®PDx™
14
To install batteries and memory card in the device:
1. Remove the back cover.
2. Remove used batteries and, if necessary, dispose of in
accordance with local regulations.
3. Insert the batteriessothattheirpositive(+)endsmatch
those shown in the diagram in the bottom of the battery
chamber.
4. Insertthemetal-connectoredgeofanSDmemorycard
into the card slot. The SDcardlabelshouldbefacingup.
Push the card in gently until it clicks into position.
Batteries and SD memory card in place Replaced Battery Cover
Note: If the card does not
click into position or you feel
resistance, it may be upside
down. Turn the card over and
try again.
Battery and memory
card installation
5. Replace battery cover.
AlicePDx back
cover removed
WARNING:
Use caution when removing
damaged batteries and avoid
exposing skin to any
battery leakage.