Respironics Alice PDx Service & Technical Reference Manual
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Respironics Alice PDx Service & Technical Reference Manual

Respironics Alice PDx Service & Technical Reference Manual

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Summary of Contents for Respironics Alice PDx

  • Page 1 Alice ® Service & Technical Reference Manual...
  • Page 2 © 2009 Koninklijke Philips Electronics N.V. 1054417, V . 01 AGE I ® Alice Service & Technical Reference Manual...
  • Page 3 IMITED ARRANTY Respironics, Inc. warrants that the Alice PDx device shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two years from the date of sale by Respironics, Inc.

  • Page 4: Table Of Contents

    LICE NTRODUCTION ..........................1 VERVIEW .........................1 NTENDED ........................1 ERVICE OTICE ........................1 ERVICE RAINING ................1 ERVICE ECHNICAL UPPORT TATEMENT , & N ARNINGS AUTIONS OTES ..........................4 ARNINGS ..........................5 AUTIONS PECIFICATIONS .......................7 HYSICAL PECIFICATIONS ....................8 PERATING PECIFICATIONS ....................9 LECTROMAGNETIC MISSIONS ....................10 LECTROMAGNETIC MMUNITY HEORY OF PERATION ..........................13...
  • Page 5 HEORY OF PERATION CONT SD C ..........................22 LED........................22 NDICATOR ROUBLESHOOTING ......................23 OMMON ROBLEMS ......................23 RROR ABLE EPAIR AND EPLACEMENT RP K ....................30 EFERENCE ABLE ........................31 ENCH HECKOUT ....................32 EPLACEMENT ROCEDURES & B ..............32 EPLACING THE ATTERY ATTERIES ..................33 EPLACING THE ATTERY NCLOSURE PCA .....................34...

  • Page 6: Alice Pd

    U.S. federal law restricts this device to sale by or on the order of a physician. VERVIEW Alice PDx 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 health care provider.
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  • Page 8: Warnings , Cautions , & Notes

    Warnings, cautions, and notes are used throughout this manual to identify possible safety hazards, conditions that may result in equipment or property damage, and important information that must be considered when performing service and testing procedures on the Alice PDx device. Please read this section carefully before servicing the Alice PDx.

  • Page 9: Warnings

    • Use only accessories that have been approved by Respironics. • Connecting the Alice PDx 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 Alice PDx.

  • Page 10: Cautions

    Do not immerse the Alice PDx device in any fluids. • Do not place liquids on or near the Alice PDx device. If liquids are spilled on the equipment, discontinue use until it can be determined that the device can be safely operated.
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  • Page 12: Specifications Physical Specifications

    Mode of Operation: Continuous operation • Not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide The Alice PDx device is designed to conform to the following standards: • IEC 60601-1, IEC 60601-1-2, •...

  • Page 13: Perating Pecifications

    PERATING PECIFICATIONS Accuracy (70-100%)(± 1 SD) - • No Motion: • Adults: ± 2 digits • Motion • Adults: ± 2 digits • Low Perfusion • Adults: ± 2 digits Standard Deviation is a statistical measure: up to 32% of the readings may fall outside these limits.

  • Page 14: Electromagnetic Emissions

    LECTROMAGNETIC MISSIONS This device is intended for use in the electromagnetic environment specified below. Use, service, and testing of the device should be performed in such an environment. & M ’ UIDANCE ANUFACTURER ECLARATION LECTROMAGNETIC MISSIONS LECTROMAGNETIC NVIRONMENT MISSIONS OMPLIANCE UIDANCE RF emissions Group 1...

  • Page 15: Lectromagnetic Mmunity

    LECTROMAGNETIC MMUNITY This device is intended for use in the electromagnetic environment specified below. Use, service, and testing of the device should be performed in such an environment. & M ’ UIDANCE ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY IEC 60601-1-2 OMPLIANCE EMC E MMUNITY NVIRONMENT UIDANCE...
  • Page 16 & M ’ UIDANCE ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY IEC 60601-1-2 OMPLIANCE EMC E MMUNITY NVIRONMENT UIDANCE EVEL EVEL Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment should be used no closer to IEC 61000-4-6 150 kHz to 80 MHz any part of the device, including cables, than recommended...
  • Page 17 & M ECOMMENDED EPARATION ISTANCES ETWEEN ORTABLE OBILE OMMUNICATIONS AND THE ERIES LATFORM LEEP HERAPY EVICES This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Electromagnetic interference may be prevented by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended in the table below, according to the maximum output power of the communications equipment.

  • Page 18: Theory Of Operation

    Personal Computer (PC), or, various Respironics CPAP and Ventilator products is provided. The Alice PDx is housed in a two-piece, hinged plastic housing. A removable cover on the back side of the housing allows user access for replacement of the three “AA” cells, which provide power for the unit. The same cover also allows access to the removable data storage card.

  • Page 19: Detailed Circuit Descriptions

    Signal from the patient electrodes enter the Alice PDx unit at J16-1 (left arm) and J16-3 (right arm) and passes through R1 and R21, which in conjunction with C7 and C22, form lowpass filters for EMC susceptibility reduction.

  • Page 20: Eeg/Eog

    Signal from the electrodes enters the Alice PDx at J7-1 and J7-2 and pass through EMC/ESD protection components CR19B, R209, C30, CR18A, C32, R210, C129, C130 and C132. The signal then passes through a highpass RC filter consisting of C158, R63, C159 and R64.

  • Page 21: Eog

    Refer to Alice PDx Analog Board Schematic sheets 7 and 8, located in the Schematics section beginning on page 53. Alice PDx contains three EMG signal conditioners which function identically to the EEG signal conditioners, but, are designed to different parameters. All EMG signal conditioners are designed to the following parameters: •...

  • Page 22: Pressure /Snore /Respiration Sensor

    When a pressure tap is connected from the Alice PDx to the patients’ mask, pressure over the range of -5 to 40 CM can be read from the sensor into the microcontroller via the sensor’s I2C port.

  • Page 23: Digital Pca

    • The ability to access many peripherals via DMA The microcontroller is responsible for coordinating the operation of Alice PDx system. Analog signals are received from the various sensors and processed by their respective conditioning circuits. These signals are then passed to the microcontroller where they are further processed for storage on the SD memory card.

  • Page 24: Body Position Sensor (Accelerometer )

    Schematics section beginning on page 53. Battery voltage is converted to the various operating voltages needed by the Alice PDx by means of three DC to DC converter circuits. These circuits supply operating voltage to the +3.3V_DIG, +3.3V_ANA and +5V busses.
  • Page 25 There are separate supplies for both the +3.3V_ANA and +3.3V_DIG busses, consisting of U24 and U25, respectively. A third DC to DC converter, U6, supplies power to the +5V bus. In this case, output voltage would always be higher than input voltage, allowing the use of a boost-only converter topology. The part chosen for this circuit was the LT3526B, by Linear Technologies.

  • Page 26: Actimetry Uart (U1)

    UART (U1) CTIMETRY NOTE Refer to Alice PDx Digital Board Schematic sheet 2 located in the Schematics section beginning on page 53. A UART (Universal Asynchronous Receiver Transmitter), which is accessible to the microcontroller via an I2C port is provided to support a future external actigraphy sensor.

  • Page 27: Lcd Driver

    53. ATTERIES Power for the Alice PDx is provided by three user-replaceable “AA” size cells which are mounted by means of spring clips to the battery board. While the preferred cell chemistry is either alkaline or NiMH, it is recognized that chemistries other than the preferred ones may be used.

  • Page 28: Common Problems

    ROUBLESHOOTING This troubleshooting guide provides a method for identifying the cause of a failure. OMMON ROBLEMS PROBLEM POSSIBLE CAUSES CORRECTIVE ACTION • • Unit will not power up Loose flex cable Replace flex cable • • Faulty Battery PCA Replace Battery PCA – check P5 connector and F1 (less than 1 ohm) •...
  • Page 29 RITICAL RRORS RROR ESCRIPTION ROBABLE AUSE ORRECTIVE CTION Reserved (Unused) Faulty Digital PCA Replace Digital PCA Boot Monitor Software Program CRC Software memory Update Software Test Failed corrupted Replace Digital PCA Main Application Software Program Software memory Update Software CRC Test Failed corrupted Replace Digital PCA SRAM Data Bus Test Failed...
  • Page 30 RITICAL RRORS RROR ESCRIPTION ROBABLE AUSE ORRECTIVE CTION • • SD Card Removed Error Wrong card Replace SD card status (write • Replace Battery PCA protected) • Replace Clamshell • Faulty Battery PCA Assembly • Loose flex cable • Replace Main •...
  • Page 31 RITICAL RRORS RROR ESCRIPTION ROBABLE AUSE ORRECTIVE CTION Serial SRAM Address Bus Test Failed Faulty Digital PCA Replace Main PCA Stack – check U36 Serial SRAM Data Location Test Faulty Digital PCA Replace Main PCA Stack – Failed check U36 RITICAL RRORS RROR...
  • Page 32 RITICAL RRORS RROR ESCRIPTION ROBABLE AUSE ORRECTIVE CTION Body Position Sensor (Accelerometer) Faulty Digital PCA Replace Main PCA Stack – Test Data Update Error check U18 UART1 Error Faulty Digital PCA Replace Main PCA Stack TD Missed Sample Error Faulty Digital PCA Replace Main PCA Stack EEPROM HW Data Checksum Failed Faulty Digital PCA...
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  • Page 34: Repair And Replacement

    EPAIR AND EPLACEMENT For technical assistance or replacement part ordering information, contact Respironics Product Support. USA and Canada Phone: 1-800-345-6443 Fax: 1-800-866-0245 Email: service@respironics.com International Phone: 1-724-387-4000 Fax: 1-800-387-5012 1054417, V . 01 ® Alice Service & Technical Reference Manual...

  • Page 35: Rp Kit Reference Table

    Power button 1054924 • Lock hook (International) • Spring, compression, 0.079” OD, 3.81lb/in • Flex cable • Alice PDx Plug Kit 1054925 Plug, large (2x) • Plug, small (2x) Power Button Power Button 1055429 • Display Enclosure (Domestic U.S.) 1054926 Display Enclosure •...

  • Page 36: Bench Checkout

    ENCH HECKOUT Prior to performing service procedures on the Alice PDx, perform the following: 1. Visually inspect the outside of the device for physical damage and broken or missing parts. 2. Power on the device and verify that self test begins.

  • Page 37: Replacement Procedures

    EPLACEMENT ROCEDURES CAUTION Repair this device only in an ESD-protected environment. NOTE Upon replacing any component, you must perform the Performance Verification/Post-Service Testing procedure. Refer to page 47 for required testing after component replacement. & B EPLACING THE ATTERY ATTERIES To remove the Battery Door &...
  • Page 38 EPLACING THE ATTERY NCLOSURE To replace the Battery Enclosure: 1. Using a Torx T8 screwdriver, remove and retain the four screws that secure the Battery Enclosure to the Clamshell Assembly. 2. Lift the Battery Enclosure away from the Battery PCA/Battery Enclosure Cover Assembly. Refer to the following illustration.
  • Page 39 2. Align the Battery PCA with the Battery Enclosure Cover. Refer to Figure D. 3. Connect the Ribbon Cable to the P5 connector on the Battery PCA. 4. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...
  • Page 40 1. Place the Power Button in the opening of the Battery Enclosure Cover. Ensure the raised center of the Button is seated in the opening of the Battery Enclosure Cover and the Button’s notch is prop- erly oriented. 2. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...
  • Page 41 ISPLAY NCLOSURE To remove the Display Enclosure: 1. Open the Alice PDx to expose the LCD. 2. Remove the four Rubber Mounts to expose the four screws that secure the Display Enclosure to the Display Enclosure Cover. 3. Remove the four screws that secure Display Enclosure to the Display Enclosure Cover.
  • Page 42 4. Slightly separate the Display Enclosure from the Display Enclosure Cover (part of the Clamshell Assembly). CAUTION A Ribbon Cable is connected between the Patient Event Button in the Display Enclosure and the Main PCA Stack. Slightly separate the Display Enclosure from the Clamshell Assembly, then disconnect the Ribbon Cable from the J10 connector on the Digital PCA.
  • Page 43 3. Secure the Display Enclosure to the Display Enclosure Cover using the four screws removed dur- ing the disassembly process. 4. Install the Rubber Mounts as shown previously in Figure F. 5. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...

  • Page 44: Main Pca Stack

    The image shown in Figure I is provided for your convenience and to illustrate the components included with the Main PCA Stack. The Main PCA Stack is assembled and calibrated by Respironics. Do not disassemble the Main PCA Stack. Handle the Main PCA Stack with extreme caution.
  • Page 45 CAUTION The J4 connector shown in the following illustration is in the unlocked position. It must be in the unlocked position when removing and connecting the LCD Ribbon Cable. Digital PCA J4 Connector P4 Connector Sensor Tube Insulator LCD Ribbon Cable (connects to J4 on the Digital PCA) IMPORTANT - CABLE MUST BE ROUTED AND FOLDED...

  • Page 46: Er Age

    3. Connect the LCD Ribbon Cable to the J4 Connector on the Digital PCA. 4. Connect the Flex Cable to the P4 Connector on the Digital PCA. 5. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...

  • Page 47: Older And / Or

    1. Install the foam on the Display Holder as shown in Figure L. 2. Install the Display in the DIsplay Holder as shown above in Figure K. 3. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...
  • Page 48 L: D IGURE ISPLAY OLDER NOTE The Hinge Cup shown in Figure L replaces a piece of foam that was installed in earlier versions of the Alice PDx. 1054417, V . 01 ® Alice Service & Technical Reference Manual...
  • Page 49 1. Place the Cannula Port the opening in the Display Enclosure as shown in Figure M. 2. Place the Cannula Port cover over the Cannula Port and snap it into place to secure the Cannula Port. 3. Assemble the remainder of the Alice PDx as necessary. 1054417, V . 01 ®...
  • Page 50 Battery Enclosure Cover N: C IGURE LAMSHELL SSEMBLY 9. Install all components into the Alice PDx and assemble the device as necessary. Refer to the pre- vious Repair/Replace sections of this Manual as necessary. 1054417, V . 01 ® Alice...

  • Page 51: Cleaning And Maintenance

    LEANING AND AINTENANCE This section describes how to clean the Alice PDx device and sensors. LICE EVICE AND OLSTER Clean the Alice PDx between uses with patients. To clean the Alice PDx device and holster: • Moisten a soft cloth with soapy water or a mild detergent. Squeeze the cloth to remove excess water.
  • Page 52 3. Ensure that an SD Card is correctly inserted in the SD Card Slot. (Indicate Pass or Fail on the data sheet.) 4. Verify that the Alice PDx device is powered ON and that the error indication symbol is not visible. If the error indication symbol is visible and flashing, power OFF the device and replace the Main PCA Stack.
  • Page 53 “restricted” on the computer if necessary. Refer to Windows Help and Support for informa- tion on security rights. (Indicate “Completed” on the data sheet.) 6. Connect the Communications cable between the Alice PDx communications connector and the USB port of host computer.
  • Page 54 Click the Enable support for Alice PDx check box and enter a “Friendly” name (a name that is recognizable to you) for the Alice PDx device. d. The name you enter will appear on the Sleepware starter bar as a device button.
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  • Page 56 ESTING HEET Device Model Number: ______________________ Device Serial Number: ______________________ RA Number (if applicable): ___________________ Test Step # Pass Fail Completed Physical Inspection Install New Batteries SD Card Turn ON - No Errors Sleepware Installation Communications Add Device Effort Belts 9 &...
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  • Page 58 CHEMATICS ROPRIETARY TATEMENT Schematics are supplied in direct support of the sale and purchase of this product. The Schematics are proprietary and confidential. Do not copy the schematics or disclose them to third parties beyond the purpose for which they are intended. The schematics are intended to satisfy administrative requirements only.
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  • Page 80 Alice ® Service & Technical Reference Manual . 1054417, V . 01 EORDER TMF 05/28/2008...

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