Respironics Alice PDx Provider Manual
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Respironics Alice PDx Provider Manual

Respironics Alice PDx Provider Manual

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REF 1053638
1049836
JDH 6/27/08

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Summary of Contents for Respironics Alice PDx

  • Page 1 REF 1053638 1049836 JDH 6/27/08...
  • Page 2 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.
  • Page 3 AlicePDx Provider Guide Table of Contents Chapter 1 Introduction Intended Use Warnings & Cautions Warnings Cautions Package Contents Product Support Limited Warranty Applicability of Warranty System Overview Good Study Indicator Symbol and Label Definitions Chapter 2 Software Installation Installing Sleepware Adding an AlicePDx Device to Sleepware ........
  • Page 4 Connecting an AlicePDx Device to a Respironics Therapy Device Connecting an AlicePDx to a Non-Respironics Therapy Device Connecting an SD Card Reader to a Computer Chapter 4 Preparing for a Sleep Study Acquisition Overview Patient Setup (Attaching Sensors) Attaching Basic Set of Sensors...
  • Page 5 Chapter 7 Troubleshooting Chapter 8 Specifications AlicePDx Device Size Classifications and Standards Compliance Power Requirements AlicePDx Temperature and Storage Information ....Sensors Disposal Appendix A Glossary Appendix B EMC Information Appendix C Understanding Channels Index Provider Guide...
  • Page 6 Alice®PDx™...
  • Page 7 AlicePDx Provider Guide 1. Introduction 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.
  • Page 8 • 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.
  • Page 9 Strong transmitter signals from TV, radio, airport, police, fire, 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.
  • Page 10 Package Contents The AlicePDx device should include the following items. If any of these items are not included, contact a Respironics representative. The AlicePDx system contents: AlicePDx device • • Device holster and lanyard • Oral thermistor sensor • Nasal cannula starter pack •...
  • Page 11 Respironics, Inc. to the customer. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will pay customary freight charges from Respironics, Inc.
  • Page 12 System overview The flow of data through the AlicePDx system begins with sensors attached to the patient. The sensors pick up physiologic signals, such as airflow, pulse oximetry, and chest and abdominal effort. Sensor cables carry the signal to the AlicePDx device. The signals are stored on the removable memory card, or, if configured to do so, the signals are sent from the AlicePDx device to a computer running the Alice Sleepware diagnostic application.
  • Page 13 Oral Thermistor Nasal Cannula Good Study Indicator Communication Port Chest Belt Abdominal Belt Pulse Oximetry ExG/Actigraphy Error Indicator AlicePDx Battery Status Memory Card Status *Actigraphy reserved for future use. AlicePDx device interface Power Button Device buttons Patient Event Button Good Study Indicator The Good Study Indicator displays how much good quality data is needed for a complete study.
  • Page 14 Symbol and Label Definitions Symbols Symbol Definition Symbol Definition Consult accompanying Type BF Applied Part documents Canadian/US Safety Prescription (Rx) only Certification Patient Event Marker (PEM) Power Button sets an event marker during recording Sensor Connection Labels Symbol Definition Symbol Definition Label for oral Label for nasal cannula connection thermistor connection Label for chest Label for abdominal...
  • Page 15 Indicates SpO connection (ABD) connection Indicates sleep study has Indicates a device error not begun or the device has Contact Respironics gathered less that 25% good for assistance quality data needed for a complete study Indicates the device has Indicates the device has...
  • Page 16 Alice®PDx™...
  • Page 17 AlicePDx Provider Guide 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. Installing Sleepware note: For more advanced Before installation, please note the following: functionality, such as Windows You must be logged onto the computer as “Administrator.
  • Page 18 Adding an AlicePDx Device to Sleepware You must add a new AlicePDx device to Sleepware before it can be used: Click on the Configure 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.
  • Page 19 AlicePDx Provider Guide 3. AlicePDx Device Setup 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.
  • Page 20 To install batteries and memory card in the device: WArnInG: Use caution when removing Remove the back cover. damaged batteries and avoid exposing skin to any battery leakage. AlicePDx back cover removed Remove used batteries and, if necessary, dispose of in accordance with local regulations.
  • Page 21 Connecting an AlicePDx Device to a note: Refer to the Sleepware respironics Therapy Device manual for a full listing of the available therapy or ventilation The AlicePDx device can be connected to a therapy device with a parameters that may be therapy device communication cable.
  • Page 22 WArnInG: 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.
  • Page 23 The AlicePDx will record the pressure and flow from a non- Respironics therapy device, but hand scoring of the other data must be performed to ensure a The AlicePDx will connect to a non-Respironics therapy device by connecting to correct diagnosis.
  • Page 24 Alice®PDx™...
  • Page 25 Clinician disconnects the AlicePDx device from the computer. • • Clinician reviews the operation of the AlicePDx and application of all of the sensors with the patient, then sends the device home with the patient. Respironics recommends that the review includes the importance of noting the Good Study Indicator (if configured) at the conclusion of each night’s study.
  • Page 26 • Clinician disconnects the AlicePDx device from the computer. • Clinician reviews the operation of the AlicePDx and application of all of the sensors with the patient, then sends the device home with the patient. Respironics recommends that the review includes the importance of noting the Good Study Indicator (if configured) at the conclusion of each night’s study. •...
  • Page 27 • At the end of the sleep period, the AlicePDx device automatically turns off. The patient should note the status of the Good Study Indicator (if configured) prior to the device turning off. • Patient returns the AlicePDx device to the clinician. • Clinician transfers the recorded sleep study acquisition from the memory card to a computer and analyzes the acquisition using Sleepware. Scenario 3: Attended or Semi-Attended study. Clinicians perform the following process: •...
  • Page 28 The following sections describe, in detail, how a sleep study is conducted with the AlicePDx device using all available channels in an attended (clinical) setting (Scenario 3 above). The clinician may also reference this section when instructing a patient in the application of sensors in scenarios 1 and 2. See Appendix C, Understanding Channels, for information about the channels that the AlicePDx equipment supports.
  • Page 29 Connect the effort belt cables to the effort belts and to the AlicePDx device. Be certain the chest belt connects to the chest connection ( ) and that the abdominal belt connects to the abdominal connection ( ). (See figure below.) Connecting effort cables to belts and AlicePDx Attach the finger SpO ) connector to the patient’s forefinger and connect the other end to the AlicePDx device. If the SpO sensor is too short, use the SpO extension cable.
  • Page 30 The figure below shows all of the basic connections. Effort belts, Spo sensor, cannula, and thermistor connected AlicePDx 9. Turn on the AlicePDx device, if it’s not already on. When the display appears, all of the icons on the display are shown for several seconds. Then, all of the icons are cleared and the busy indicator appears on the screen until the device is initialized.
  • Page 31 Once initialized, several symbols appear on the screen: Good Study indicator, memory card status, and the connection indicators. If a connection is loose or missing, the indicator symbol for it flashes until the connection is made. Good Study Indicator Connection Connection Indicators Indicators...
  • Page 32 Type Lead number Colors north American ECG yoke (according to AAMI, AHA-Code, or US Code) Single Lead ECG Lead II RA (right arm) = White LL (left leg) = Red RL (right leg) = Green note: Do not connect the RL lead if you are using an EEG Neuroground 6-Lead ECG Lead I RA (right arm) = White LA (left arm) = Black RL (right leg) = Green...
  • Page 33 5. Attach the patch for the left leg on the patient’s left side CAUTIon at the lowest rib. Do not place the patch forward toward If you use an ExG Neuroground, the patient’s stomach; it should be placed directly on the do not use the right leg/ground patient’s side. ECG lead. Attach the patch for the ECG V to the chest using any of the “V” positions as seen in the figure below. Placements of ECG V Connect the ECG lead cables to appropriate color-coded locations on the ECG yoke, as shown in the figure below.
  • Page 34 Attaching Optional ExG Electrodes Attach the ExG electrodes in the manner specified by your facility’s protocol and based on the configuration you choose. Complete the following steps to attach ExG sensors to a patient: 1. Following the manufacturer’s recommendations, attach the ExG leads to the patient’s scalp in accordance with your facility’s procedures. The AlicePDx ExG inputs are arranged as follows: • R1 – reference electrode o N1 – electrode input tied to reference R1 o N2 – electrode input tied to reference R1 • R2 – reference electrode o N3 – electrode input tied to reference R2 o N4 – electrode input tied to reference R2 •...
  • Page 35 CAUTIon If you use an EEG Neuroground, do not use the right leg/ground lead. Attaching ExG cables to ExG yoke 6. Attach the ExG yoke to the other side of the chest effort belt and connect the yoke cable to the AlicePDx device. 7.
  • Page 36 Before running an acquisition, you should review your cable connections and check your equipment as specified below: 1. Verify that the AlicePDx device is on and that the error indication symbol ( ) is not visible. Normally, the error indicator is not visible. If it is visible and flashing, turn off the device and contact Respironics. 2. Verify that all the visual indicators for the configured channels located on both sides of the screen on the AlicePDx device are solid (not flashing). 3. Check the battery indicator symbol ( ). Normally, the battery indicator does not remain on the screen. However, if the battery is low, the battery indicator does appear and flashes until it is replaced.
  • Page 37 Last Good Study indicator Last Good Study indicator on screen AlicePDx recording Patient Events A patient can record an event during the acquisition by pressing the Patient Events button on the AlicePDx device to indicate a non-sleep event. For example, if the patient wakes up and gets out of bed during the night, he or she could make a note of it by pressing the Patient Event button, located on the front of the closed device.
  • Page 38 Alice®PDx™...
  • Page 39 AlicePDx Provider Guide 5. Performing an Acquisition This chapter discusses how to begin acquisitions, view them in real time, and how to import acquisition data from an SD memory card. Starting a real Time Acquisition To start the data acquisition, complete the following steps: 1. If Sleepware’s Alice Starter module is not already running on your computer, double-click on the Alice Starter icon ( The name of your AlicePDx device appears in the Starter bar at the top of the computer screen, along with the words “No Signal.” This indicates the AlicePDx device is not connected.
  • Page 40 As the acquisition progresses, the Good Study symbols (if configured) display the status of good quality data gathered for the study in 25% increments. (Refer to Symbol and Label Definitions for details.) The patient should note the Good Study Indicator at the conclusion of each night’s study. The last Good Study indicator to appear on the screen before the device is turned off will reappear on the screen once the device is turned back on. This feature enables you to learn how much of the sleep study was successful in the event that the patient forgets to check the Good Study indicator.
  • Page 41 AlicePDx Provider Guide 6. Cleaning and Maintenance This chapter describes how to clean the AlicePDx device and CAUTIon sensors. Never use harsh cleaning agents or chemicals. Never AlicePDx Device and Holster spray cleaner directly onto the Clean the AlicePDx between uses with patients. device.
  • Page 42 Any device, channel, or signal failures should of wear. Discontinue use and be referred to a Respironics Service facility. replace if damaged. Alice®PDx™...
  • Page 43 Possible device failure, contact Display is blank Respironics Product Support for assistance • Device error, contact Respironics Wrench ( ) flashing on screen Product Support for assistance If your problem is still not resolved after following the solutions described above, contact Respironics Product Support for further assistance at 1-800-345-6443. Provider Guide...
  • Page 44 Alice®PDx™...
  • Page 45 AlicePDx Provider Guide 8. Specifications AlicePDx Device Size Dimensions: 5” L x 3” W x 2” H (12.7 cm x 7.62 cm x 5.08 cm) Weight: Approximately 8 oz (230 grams), (weight does not include batteries) Classifications and Standards Compliance Classifications The AlicePDx device is classified as follows: • Type of Protection Against Electric Shock: Internally powered equipment. • Degree of Protection Against Electric Shock: Type BF Applied part • Degree of protection against harmful ingress of water: – IPX0 (Ordinary protection against the ingress of liquids) • Mode of Operation: Continuous operation • Not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide Standards Compliance The AlicePDx device is designed to conform to the following standards: IEC 60601-1, IEC 60601-1-2, EN 60601-1, EN 60601-1-2, UL 60601-1, CSA 22.2 No. 601.1, and AS 3200.1.0.
  • Page 46 AlicePDx Temperature and Storage Information operation Storage Temperature: 41°F to 95°F (+5°C to +35°C) -4°F to 140°F (-20°C to +60°C) Humidity: 15% to 95% RH non-condensing 15% to 95% RH non-condensing Atmospheric Pressure: 70 to 102 kPa 70 to 102 kPa Sensors oxygen Saturation range 0 to 100% Pulse rate range 18 to 300 pulses per minute Measurement Wavelengths Red: 660 nanometers @3mW Nominal...
  • Page 47 AlicePDx Provider Guide Appendix A: Glossary The following terms and acronyms appear in this manual: Acquisition A collection of polysomnographic data that has been acquired during a patient study. Configuration The set of channels used to acquire polysomnographic data. ECG Electrocardiogram (also called EKG) – A recording of cardiac electrical activity.
  • Page 48 Polysomnography. SD Secure Digital (flash memory card). Sleepware The Respironics software application that runs via the Windows operating system and that receives and analyzes physiologic data from Respironics diagnostic equipment. Sleepware Starter Bar The component of Sleepware that appears at the top of the computer screen and is used during equipment setup for configuration and during data acquisitions to view settings.
  • Page 49 AlicePDx Provider Guide Appendix B: EMC Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance...
  • Page 50 Immunity Test IEC 60601-1-2 Test Compliance Level Electromagnetic Environment - Level Guidance Voltage dips, short <5% U (>95% dip in U Not applicable for This device is suitable for all establishments, interruptions and voltage for 0.5 cycle battery operated devices including domestic establishments variations on power supply input lines 40% U (60% dip in U...
  • Page 51 recommended Separation Distances between Portable and Mobile rF Communications Equipment and This Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment. rated Maximum Power output of Transmitter Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz...
  • Page 52 Alice®PDx™...
  • Page 53 AlicePDx Provider Guide Appendix C: Understanding Channels Channels refer to the different types of data collected by the sensors and therapy devices connected to the patient. The set of channels used in any particular sleep study is referred to as a configuration.
  • Page 54 The table below provides the following information about each of the AlicePDx device channels: • The Channel column lists the name of the channel. The Channel Quantity column tells how many inputs are available on the AlicePDx device for • each channel. The Sample Size (in bits) column specifies the bit resolution for the channel being acquired.
  • Page 55 Airflow The airflow channels are used to display data from a device that measures the patient’s airflow. You can use the airflow sensor channel type by connecting a Respironics thermistor or pressure cannula airflow sensor to the AlicePDx device. note: If you label this channel “Flow,” the Sleepware software can scan the data and automatically score apneas and hypopneas.
  • Page 56 OSA patient. As you add this channel to your configuration, you can enter your own label (up to eight characters) from the channel details form. note: The AlicePDx will record the pressure and flow from a non-Respironics therapy device, but hand scoring of the other data must be performed to ensure a correct diagnosis. Alice®PDx™...
  • Page 57 AlicePDx Provider Guide Index Index Actigraphy 7,8,47 batteries 2,4,13,14,19,20,21,37,39 cannula 4,6,7,8,9,17,23,24,36,37,48,49,50 Caution 2,3 communication cable 4,15,33 ECG 3,4,6,8,9,25,26,27,29,36,41,48,49 effort belts 4,6,22,23 ExG 4,6,8,9,27,28,29,36,41,48,50 Good Study Indicator 6,7,19,20,21,30,34 Provider Guide...
  • Page 58 holster 4,13,22,35 lanyard 4,22,35 Patient Event 8,31 pulse oximetry 6,7,42 SD card 4,14,15,17,21,34 Sleepware 1,6,11,12,15,19,20,21,28,33,34,42,47,49,50 4,6,7,9,23,24,25,37,40,42,49,50 Symbols 8 therapy device 4,8,15,16,17,20,21,49,50 thermistor 4,6,7,8,9,23,24,36,49 Warning 2 Warranty 5 Alice®PDx™...

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