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.