ES ED: S8 Elite Clinician's Manual USA English PDF Copy - Not For Printing
ES ED: S8 Elite Clinician's Manual USA English PDF Copy - Not For Printing
Proprietary Information, not to be reproduced or made available to third parties        DOC NO       338195
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© ResMed Ltd. 2005                                                                      REV          1
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                                                    S8 Elite™ System
Component of 338195/1                                                    ILLUSTRATIONS
A SYSTEM COMPONENTS
                                                                                                                                                                                               1                        2
                  LCD screen                                  Keypad
1 2 3
AC input
2 9’10” (3 m)
                                                                                                        4                              5                6
                                                                                   © 2005 ResMed Ltd.
F BLANK MODULE
                           Data
                           communications
                           port
     1                                      2
CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
        USER/OWNER RESPONSIBILITY                                                                         1
MEDICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
        INDICATIONS FOR USE                                                                               3
        CONTRAINDICATIONS                                                                                 3
        WARNINGS                                                                                          3
        CAUTIONS                                                                                          4
        ADVERSE EFFECTS                                                                                   4
THE S8 ELITE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
        S8 ELITE                                                                                          7
        MASKS                                                                                             7
        HUMIDIFIER                                                                                        8
        DATA MANAGEMENT PRODUCTS                                                                          8
        ACCESSORIES                                                                                       8
OPERATING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
        PRINCIPLES OF OPERATION                                                                          9
        SYSTEM SETUP                                                                                    10
        DELIVERING THERAPY                                                                              11
NAVIGATING THE S8 ELITE MENUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
        S8 ELITE KEYPAD AND LCD                                                                         15
        S8 ELITE MENUS                                                                                  16
DATA MANAGEMENT USING THE MENUS . . . . . . . . . . . . . . . . . . . . . . . . 27
        CLINICAL MENU RESULTS                                                                           27
        INTERPRETING DATA IN THE CLINICAL MENU                                                          30
        SMART DATA IN THE PATIENT MENU                                                                  31
S8 DATA MANAGEMENT PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
        USING A BLANK MODULE                                                                            33
        USING THE RESSCAN DATA CARD MODULE                                                              33
        PATIENT MANAGEMENT OF THE DATA CARD                                                             33
        TRANSMITTING DATA WITH THE DATA CARD                                                            36
        S8 ADAPTERS                                                                                     37
CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
        DAILY CLEANING                                                                                  39
        WEEKLY CLEANING                                                                                 39
        PERIODIC CLEANING                                                                               39
        REPLACING THE AIR FILTER                                                                        40
        SERVICING                                                                                       40
                                                                                                    CONTENTS   iii
     FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
     TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
     SYSTEM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
              S8 ELITE (WITHOUT ACCESSORIES)                                                                         49
              ACCESSORIES                                                                                            49
              ALL DEVICES (WHERE APPLICABLE)                                                                         50
              SYMBOLS WHICH APPEAR ON THE DEVICE                                                                     50
     INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
iv
INTRODUCTION
    The ResMed S8 ELITE™ system is designed to provide continuous positive airway
    pressure (CPAP) therapy to patients with obstructive sleep apnea (OSA). The device
    delivers a fixed treatment pressure within the range 4 to 20 cm H2O.
    Patients with OSA experience recurrent obstruction of their upper airway (apneas)
    due to relaxation of the tongue and soft palate while they sleep. Common symptoms
    are associated with poor sleep quality and may include excessive daytime sleepiness
    and tiredness, as well as diminished concentration and memory loss.
    Data storage and processing capabilities of the S8 ELITE system facilitate patient
    management. The system provides summary data for a variety of time intervals, which
    can be viewed via the LCD menus. The patient’s usage hours, treatment pressure,
    mask leak, apnea + hypopnea index (AHI), apnea index (AI), and hypopnea index (HI)
    are displayed in the Results section of the clinical menu. At your discretion, the patient
    may view mask fit, treatment pressure, and usage hours for the last session. This patient
    feature is called SMART DATA™.
    You can download the data stored in the S8 ELITE and review it in a PC-based software
    program. You can download the data directly, via cable. You can also access the data
    remotely, using a RESSCAN™ Data Card. A patient’s therapy and reminder settings can
    also be updated using the software. Patient data can be accessed and S8™ device
    settings updated either via direct cable connection to the S8 ELITE or remotely, via a
    Data Card.
USER/OWNER RESPONSIBILITY
    The user or owner of this system shall have sole responsibility and liability for any injury
    to persons or damage to property resulting from:
    •   operation which is not in accordance with the operating instructions supplied
    •   maintenance or modifications carried out unless in accordance with authorized
        instructions and by authorized persons.
    Please read this manual carefully before use.
    This manual contains special terms and icons that appear in the margins to draw your
    attention to specific and important information.
    • Warning alerts you to possible injury.
    • Caution explains special measures for the safe and effective use of the device.
    • Note is an informative or helpful note.
                                                                                INTRODUCTION       1
2
MEDICAL INFORMATION
INDICATIONS FOR USE
      The S8 ELITE CPAP system is indicated for the treatment of obstructive sleep apnea
      (OSA) in adult patients.
      The S8 ELITE CPAP system is intended for home and hospital use.
      CAUTION
  !   In the US, Federal law restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS
      The S8 ELITE is not a life support device and may stop operating with power failure or
      certain fault conditions. It should not be used by patients who are dependent on
      continuous therapy.
      Positive airway pressure therapy may be contraindicated in some patients with the
      following pre-existing conditions:
      • severe bullous lung disease
      • pneumothorax
      • pathologically low blood pressure
      • dehydration
      • cerebrospinal fluid leak, recent cranial surgery, or trauma.
WARNINGS
      • The entire manual should be read before using the S8 ELITE.
      • Advice contained in this manual should not supersede instructions given by the
        prescribing physician.
      • A patient should not connect a device to the data communication port unless
        instructed to do so by their health care provider or physician. Only ResMed
        products are designed to be connected to the data communication port.
        Connecting other devices could result in injury, or damage to the S8 ELITE device.
      • The S8 ELITE should only be used with masks (and connectors*) recommended by
        ResMed, or by a physician or respiratory therapist. A mask should not be used
        unless the S8 ELITE device is turned on and operating properly. The vent hole or
        holes associated with the mask should never be blocked.
        Explanation: The S8 ELITE is intended to be used with special masks (or
        connectors*) which have vent holes to allow continuous flow of air out of the
        mask.
        When the device is turned on and functioning properly, new air from the device
        flushes the exhaled air out through the mask vent holes. However, when the
        device is not operating, insufficient fresh air will be provided through the mask, and
* Ports may be incorporated in the mask or in connectors that are near the mask.
                                                                                   MEDICAL INFORMATION   3
          the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than
          several minutes can, in some circumstances, lead to suffocation. This applies to
          most models of CPAP devices.
        • In the event of power failure or machine malfunction, remove the mask.
        • The S8 ELITE can be set to deliver pressures up to 20 cm H2O. In the unlikely
          event of certain fault conditions, pressures up to 30 cm H2O are possible.
        • If oxygen is used with this device, the oxygen flow must be turned off when the
          device is not operating.
          Explanation: When the CPAP device is not in operation and the oxygen flow is
          left on, oxygen delivered into the air delivery tubing may accumulate within the
          CPAP machine enclosure and create a risk of fire. This applies to most types of
          CPAP machines.
          • Oxygen supports combustion. Oxygen should not be used while you are
              smoking or in the presence of an open flame.
          • Always ensure airflow is being generated by the device before the oxygen
              supply is turned on.
          • Always turn the oxygen supply off before stopping the airflow from the device.
          Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration
          will vary, depending on where the oxygen is introduced, the pressure settings, patient
          breathing pattern, and leak rate.
        • Do not use the S8 ELITE if there are obvious external defects or unexplained
          changes in performance.
        • Do not open the S8 ELITE case. There are no user serviceable parts inside. Repairs
          and internal servicing should only be performed by an authorized service agent.
        • Explosion hazard—do not use in the vicinity of flammable anesthetics.
    CAUTIONS
        • At low pressures, the flow through the exhalation ports of your mask may not
          clear all exhaled gas from the tubing. Some rebreathing may occur.
        • The air flow for breathing produced by this device can be as much as 11°F (6°C)
          higher than the temperature of the room. Caution should be exercised if the room
          temperature is warmer than 90°F (32°C).
        Note: The above are general warnings and cautions. Specific warnings, cautions, and
        notes appear with the relevant instructions in the manual.
    ADVERSE EFFECTS
        Patients should report unusual chest pain, severe headache, or increased
        breathlessness to their prescribing physician. An acute upper respiratory tract infection
        may require temporary discontinuation of treatment.
4
The following side effects may arise during the course of therapy with the S8 device:
•   drying of the nose, mouth, or throat
•   nosebleed
•   bloating
•   ear or sinus discomfort
•   eye irritation
•   skin rashes
•   chest discomfort.
                                                              MEDICAL INFORMATION       5
6
THE S8 ELITE SYSTEM
     A complete S8 ELITE system comprises the following elements:
     •   S8 ELITE flow generator
     • Mask
     • Humidifier
     • Data management products
     • Accessories.
S8 ELITE
     The components of the S8 ELITE device are shown in the illustration sheet at the front
     of this manual:
     • Front view (A-1)
     • Rear view (A-2)
     • Power cord (A-3)
     • Carry bag (A-4). The S8 ELITE carry bag contains two pouches: one for storing the
       S8 device, one for storing the HUMIDAIRE 3i.
     • 6‘6” (2 m) air tubing (A-5).
MASKS
     Patients will also need a ResMed mask system (supplied separately).
     The ResMed mask systems that are recommended for use with the S8 ELITE are:
     NASAL MASKS
     • MODULAR NASAL MASK
     • MIRAGE VISTA™ NASAL MASK
     • ULTRA MIRAGE™ NASAL MASK
     • MIRAGE™ NASAL MASK
     • MIRAGE ACTIVA™ NASAL MASK
     • PAPILLON™.
    HUMIDIFIER
         The S8 ELITE is compatible for use with the HUMIDAIRE 3i integrated heated
         humidifier (B).
         See “Using Humidifiers” on page 13.
         Note: Ensure that at least one module or adapter is connected to the S8 Elite at all
         times.
    ACCESSORIES
         The other accessories shown on the illustration sheet may also be purchased
         separately.
         • Front cap (not available in all regions) (C-5)
         • Air tubing 9‘10” (3 m)(C-6)
         • DC-12 converter (C-7)
         • Blank module (C-8).
         Note: ResMed regularly releases new products. Please check our website at
         <www.resmed.com>.
8
OPERATING INFORMATION
PRINCIPLES OF OPERATION
    The S8 ELITE system is designed for clinical use and home treatment of adult patients
    with obstructive sleep apnea (OSA). The S8 ELITE device provides fixed-positive-
    pressure room air via tubing to the mask worn by your patient. The continuous air
    stream “splints” open the upper airway, preventing airway collapse.
    The S8 ELITE delivers pressure within the range 4 to 20 cm H2O, depending on the
    patency of the upper airway. To make the beginning of treatment more comfortable,
    you may set a ramp so the pressure starts low and gradually increases to full treatment
    pressure over the ramp time.
    EXPIRATORY PRESSURE RELIEF
    Note: EPR may not be available in all regions.
    In the S8 ELITE, you can select expiratory pressure relief (EPR). EPR is designed to
    maintain optimal CPAP treatment for the patient during inhalation and reduce the
    delivered mask pressure during exhalation. The desired result of EPR is to decrease the
    pressure the patient must breathe out against, making the overall CPAP therapy more
    comfortable.
    The features of EPR are:
    • EPR is disabled automatically in the event of an apnea.
    • EPR resumes automatically when the apnea event has passed.
    • You can select an EPR pressure drop of OFF, 1, 2, or 3 cm H2O.
    • You can set EPR to be off, delivered only during ramping, or delivered throughout
        therapy.
    • Pressure drop is limited, to avoid sub-optimal treatment (maximum drop is
        3 cm H2O).
    • When EPR is enabled, the delivered pressure will not drop below a minimum
        pressure of 4 cm H2O, even if, for example, the set pressure is 6 cm H2O and the
        EPR setting is 3.
    • Either the clinician alone, or both the clinician and the patient can access the EPR
        setting. You can enable or disable patient access to the EPR setting.
    Note: When EPR is enabled, detection of apneas and hypopneas may become less
    reliable at high levels of leak (> 0.4 L/s — 24 L/min).
                                                                 OPERATING INFORMATION        9
             The dotted line on the graph illustrates the performance of the S8 ELITE with EPR set.
                                                                                    EPR algorithm
                                                  12
                                                        Indicat ive mask pressure
                 Flow (l/min)/Pressure (cm H2O)
10
                                                  4
                                                       Flow
                                                  2
                                                  -2
                                                                 CPAP TREATM ENT                   EPR TREATM ENT
                                                  -4
                                                                                          T im e
     SYSTEM SETUP
     1       Place the S8 ELITE on a table near the head of the patient’s bed.
             CAUTION
         !   Be careful to place the device where it cannot be bumped, and where no one will
             trip over the power cord.
             Note: The S8 Elite device may be placed on the floor beside or underneath the patient’s
             bed. Ensure that the area is free from dust and clear of bedding, clothes, or any other
             objects that could block the air inlet.
     2       Connect the AC power cord or ResMed DC-12 converter (not supplied) to the
             corresponding socket on the rear of the S8 ELITE (D-1). Plug the other end of the
             power cord or adapter cable into the appropriate power outlet.
             WARNING
         !   • Make sure the power cord and plug or adapter cable are in good condition and
               the equipment is not damaged.
             • In the clinical environment any personal computer that is used with your CPAP
               system must be at least 5’ (1.5 m) away from, or at least 8’ (2.5 m) above, the
               patient. It must also comply with the relevant test standard. For personal
               computers the international standard is IEC 60950 or equivalent.
     3       Connect one end of the air tubing firmly onto the air outlet of the device (D-2) and
             the other end to the mask system (D-3).
             When the S8 ELITE unit is powered up, the Welcome screen is displayed, followed by
             the standby (RAMP) screen.
             The S8 ELITE system is now ready for use (D-4).
             Note: The S8 Elite uses an internal pressure sensor, and therefore does not require
             calibration by a clinician or patient.
10
    SMARTSTART™
        If you enable the SmartStart™ function, the patient’s device will start automatically
        when they breathe into their mask, and will stop automatically when they take the
        mask off. This means that the patient does not have to press the Start/Stop key to
        begin or end treatment. See “Clinical Menu” on page 19 for details about enabling
        SmartStart.
        Note: A patient must not use SmartStart if they are using a mask with an anti-asphyxia
        valve, such as the Mirage Full Face Mask.
DELIVERING THERAPY
        WARNING
    !   A mask should not be used unless the S8 Elite is turned on and operating properly.
        WARNING
    !   • Do not leave long lengths of air tubing around the top of the bed; they may twist
          around the patient's head or neck while they are sleeping.
        • Blocking the air inlet or tubing while in operation could lead to overheating of
          the device.
3 Instruct the patient to put on the mask according to the mask user instructions.
5 At the end of the ramp period, the LCD will display the word ‘CPAP’.
                                                                        OPERATING INFORMATION          11
     6       Stop therapy in one of two ways:
             • Remove the mask, and press the Start/Stop key to stop airflow.
             • If SmartStart/Stop is enabled, simply remove the mask and treatment will stop
                automatically.
     1       Instruct the patient to lie down in bed. If desired, place the tubing over the top of the
             headboard to reduce drag on the mask.
             WARNING
         !   Do not leave long lengths of air tubing around the top of the bed; they may twist
             around the patient’s head or neck while sleeping.
2 Instruct the patient to put the mask on according to the mask user instructions.
     3       Hold down the Start/Stop key on the control panel (see Figure 1, S8 Elite Keypad
             and LCD, on page 15) for at least 3 seconds until pressure delivery starts and the
             following screen appears:
             Note: The mask-fit pressure is the set treatment pressure, or 10 cm H2O, whichever is
             greater.
12
      Table 1: Star ratings for the mask-fit and patient Smart Data features
      Note: While using the mask-fit feature, the star rating values are indicative of the
      instantaneous leak calculated over the last 10 seconds.
      Smart Data (designed for the patient) also uses a star rating for mask fit. The Smart Data
      star rating values correspond to 70th centile mask leak for the last session. A five-star
      rating is displayed, for example, if the leak rate was less than 0.10 L/s for 70% of the
      session.
5     After three minutes, the pressure will revert to the set pressure, and treatment will
      begin.
      • If you do not wish to wait three minutes, hold down the Start/Stop key for three
        seconds and treatment will begin immediately.
      • If you press the Start/Stop key briefly (ie, for less than three seconds), the device
        will return to standby mode (the RAMP screen is displayed).
    USING HUMIDIFIERS
      Please refer to the illustration in section E of the illustration sheet, and your HumidAire 3i
      manual.
      The HUMIDAIRE 3i attaches to the front of the S8 ELITE to provide heated
      humidification. No other accessories are required for its use.
      Notes:
      a. Make sure the water chamber of the HumidAire 3i is empty before you attach or
         detach the humidifier.
      b. Remove the connector plug on the S8 Elite before you attach the HumidAire 3i.
         Reattach the connector plug firmly after you detach the humidifier.
      STORING THE HUMIDAIRE 3i
      Store the HUMIDAIRE 3i in the larger, mesh-top pouch when not in use.
                                                                        OPERATING INFORMATION          13
14
NAVIGATING THE S8 ELITE MENUS
S8 ELITE KEYPAD AND LCD
    The control panel of the S8 ELITE includes a keypad for navigating through the menus
    and delivering treatment.
LCD screen
               Up key
                                                                          Right key
              Left key
                                                                          Start/Stop key
            Down key
    The LCD is used to display the menus and other data. The arrows and lowercase text
    on the bottom line of the LCD prompt the use of the keys within the menus.
    The keypad is used to navigate through the menus, access the mask-fit feature, and
    start/stop treatment. The functions of the keys and quick key combinations are listed
    in Table 2.
    The LCD backlight turns off after two minutes of inactivity. It turns back on when you
    press a key.
    Table 2: Keys on the front panel and their functions
     Key                    Function
     LCD screen             • Displays S8 Elite information including the menus and
                              treatment screens.
           Left + Right          • Extended hold (for at least 3 seconds) gives quick access to
                                   the clinical menu Results section only. It does not allow
                   +               further navigation (eg, to other sections of the clinical menu);
                                   see Figure 7, The clinical menu results series, on page 28.
         When the S8 device is in standby mode all keys remain lit. During therapy, the keypad
         backlight turns off after two minutes of inactivity and the Start/Stop key dims.
     S8 ELITE MENUS
         The S8 ELITE LCD displays a variety of submenus, parameters, and data. Whether the
         machine is in standby mode, or delivering therapy, you can view and change settings.
         When the S8 ELITE is first turned on, the Welcome screen appears while the device is
         performing self-checks.
       PATIENT MENU
         Depending on what menu type you have set in the clinical menu, the patient will see
         a standard or detailed menu.
16
Figure 2 summarizes the standard patient menu series.
         WELCOME
         >>>>>>
         RAMP: 10min
         menu
        EPR SETTING: 1
        change            exit
        MASK: ULTRA
        change            exit
        SW: SX3960200
                           exit
              RAMP: 10 min
              menu
              SETTINGS
              enter           exit
                                              EPR SETTING: 1
                                              change             exit
                                              MASK: ULTRA
                                              change             exit
                                              TUBE LENGTH: 2m
                                              change          exit
                                              HUMID: NONE
                                              change             exit
                                              SMARTSTART: ON
                                              change         exit
                                               USAGE:    1000/1068
                                                               exit
                                               SMART DATA
                                               enter             exit
              OPTIONS
              enter          exit
                                              SMART DATA                AUTO APPEAR: OFF
                                              enter              exit   change    cancel
                                               LANG: ENGLISH
                                               change       exit
              SERVICING
              enter          exit
                                               SN: 12345678912
                                                                 exit
                                               PCB: 123456789123
                                               4567           exit
                                               SW: SX3960200
                                                                 exit
18
  Note: The Results menu and Smart Data in the Options menu are displayed only if you
  have set one or more Smart Data options to ON in Clinical Menu, Options, Smart Data.
  Parameters in the standard and detailed patient menus are described in Table 3 on
  page 22. Those parameters that appear in one or both patient menus and the clinical
  menu are marked with an asterisk (*).
CLINICAL MENU
  Access the clinical menu from the standby screen by holding down the Right and
  Down keys simultaneously for at least three seconds.
  The flow charts in Figures 4–6 summarize the clinical menu series. For an expanded
  view of the Results section, see “The clinical menu results series” on page 28.
  To navigate and make selections within the clinical menu, use:
  • the Up/Down key to scroll through items within a level
  • the Left key to enter a submenu and to apply an option choice
  • the Right key to navigate out of a menu or submenu, and to exit without
    changing options.
  Parameters in the clinical menu are described in Table 3, “Descriptions of parameters
  in the patient menu and the clinical menu,” on page 22.
  EPR (EXPIRATORY PRESSURE RELIEF)
  Note: EPR may not be available in all regions.
  You can set the S8 ELITE to provide EPR (expiratory pressure relief). You may want to
  set EPR for patients who find it difficult to exhale against positive airway pressure. EPR
  provides a small reduction to CPAP during exhalation, reducing patient effort.
  You can switch EPR off completely, set it for use during ramp only, or set it for full-
  time use during therapy (including the ramp period).
  There are three levels of EPR available, each level corresponding to different levels of
  pressure relief. 1, 2, and 3 provide varying levels of EPR, with 3 providing the highest
  level. You can also set EPR to OFF. You can either set the EPR level only, or you can
  set the EPR level and enable patients to modify their level of EPR via the EPR SETTING
  screen in the patient menus.
  Figure 4 shows the main menu screens. The Settings menu is expanded in Figure 5.
  The Options menu is expanded in Figure 6.
          CLINICAL MENU
             WELCOME
         CLINICAL
         menu          exit
         RESULTS
         enter         exit
                                      EFFICACY DATA
                                                                SEE Figure 7 on
                                      enter         exit        page 28
                                      SN:12345678912
                                                         exit
                                      PCB: 123456789123
                                      4567             exit
                                      SW: SW3960200
                                                         exit
                                      BR: 19200
                                      change            exit
20
                                  SETTINGS
                                  enter             exit
                                  MODE: CPAP
                                                     exit
                                  CPAP: 10.0
                                  change            exit
                                  MAX RAMP: 30
                                  change            exit
                                  MASK: ULTRA
                                  change            exit
                                  TUBE LENGTH: 2m
                                  change            exit
                                  HUMID: NONE
                                  change            exit
                                  SMARTSTART: ON
                                  change            exit
                             SMART DATA
                             enter            exit
Table 3: Descriptions of parameters in the patient menu and the clinical menu
                     Start CPAP                      Sets the pressure at the start of the ramp up to fixed
                                                     treatment pressure.
Max Ramp Limits the ramp times the patient may select.
22
Menu      Parameter          Description
          Usage Data         Displays usage data for a range of time intervals. For
                             details, see “Clinical Menu Results” on page 27.
Options   Smart Data*        Allows the clinician to select which Smart Data
                             screens, if any, are displayed in the patient menu.
                             Note: if you wish to make Smart Data available, set
                             one or more of the options (Mask Fit, Pressure, or
                             Usage) to ON. Set Auto Appear to ON so that the
                             Smart Data screens are displayed in the morning if
                             the patient resets the device.
                             In the patient menu, the Smart Data menu is
                             displayed only if one or more of the options have
                             been set to ON by the clinician. If AutoAppear is set
                             to OFF, Smart Data is displayed in the Results menu
                             only.
                       Erase Data?             Allows the clinician to erase all data stored in the
                                               device (except for Run Hours).
                                               Settings are not affected.
                       Menu Type               Sets the menu that the patient will see: standard
                                               (STD) or detailed (ADV).
              *   These parameters may appear in one or both patient menus and the clinical
                  menu.
              †
                  More detailed data is available via your PC application.
          Note: When Leak Alert is set to ON, SmartStart/Stop is automatically set to OFF.
          SmartStart/Stop cannot be used with Leak Alert because, if a high leak occurs, SmartStop
          may stop treatment before the Leak Alert signal is activated.
Settings Mask
24
  Table 4: Settings for mask types
Settings Mask
SETTING REMINDERS
  You can set a number of reminders to alert the patient to specific events; for example,
  when to replace their mask, when to insert a Data Card (if their device is Data Card
  enabled) and so on. You can also set special customized reminders.
  When a reminder is due, a message is displayed on the LCD and remains whenever
  the device is not delivering therapy. The backlight on the LCD flashes when a message
  is displayed.
  If more than one reminder for a patient is scheduled for the same date, all scheduled
  reminders are displayed on that date. Patients can clear each message by pressing the
  Left key (or inserting a Data Card, in the case of the Data Card reminder).
  You access reminders from Clinical Menu, Options (see Figure 5, Settings menu
  screens, on page 21). From the REMINDERS screen, scroll down to the submenus to
  set a number of different types of message.
  REPLACE MASK
  You can set a timed reminder to remind a patient when they need to replace their
  mask. The patient can press the Left (Ok) key to remove the message from the LCD.
  CALL PROVIDER
  You can set a timed reminder for your patient to phone you at a certain time; for
  example, to discuss how their therapy is going. The patient can press the Left (Ok)
  key to remove the message from the LCD.
  INSERT CARD
  If a patient’s flow generator is Data Card enabled, you can set a timed reminder on the
  flow generator to remind them that they need to insert a Data Card to transfer patient
  data. This enables you to establish compliance. The patient should actually insert the
  Data Card in order to clear the message from the LCD. (They can also press the Left
  (Ok) key to remove the message.)
  REPLACE FILTER
  You can set a timed reminder to remind your patient when to replace the air filter.
  The patient can press the Left (Ok) key to remove the message from the LCD.
      Replace mask (MASK)        OFF                   7-day increments, starting from the current set
                                                       date
      Call provider (CALL)       OFF                   7-day increments, starting from the current set
                                                       date
      Insert Card (CARD)         OFF                   7-day increments, starting from the current set
                                                       date
      Change filter (FILT)       OFF                   7-day increments, starting from the current set
                                                       date
      Service due (SERV)         OFF                   7-day increments, starting from the current set
                                                       date
      Customized reminder        OFF                   7-day increments, starting from the current set
      (CUST)                                           date
26
DATA MANAGEMENT USING THE MENUS
    The S8 ELITE system may be used to monitor patient usage as well as treatment
    pressure, mask leak, and incidence of apneas and hypopneas. To assess the patient’s
    progress, data for the last session may be compared to median values for the last week,
    the last month, the last six months, and the last year, as displayed in the Results menu.
    The device stores usage and summary data for up to 365 sessions.
    Comprehensive patient data can be viewed either on the LCD or in a PC software
    application. Data and settings can be transferred between the S8 ELITE and the PC
    application via S8 data management products. See “S8 Data Management Products”
    on page 33.
                                                               EFFICACY DATA
                                                                 EFFICACY DATA         PRESS: 10.2               PRESS: 12.4             PRESS: 12.8             PRESS: 12.8             PRESS: NO DATA
                                                               enter           exit    day...           exit     wk...            exit   mth...           exit   6mths...         exit   yr...          exit
                                                                                       LEAK: 0.70L/s             LEAK: 0.40L/s           LEAK: 0.20L/s           LEAK: 0.40L/s           LEAK: NO DATA
                                                                                       day...           exit     wk...            exit   mth...           exit   6mths...         exit   yr...         exit
                                                                                        AI: 1000                 AI: 1000                AI: 800.4               AI: 8.0                 AI: NO DATA
                                                                                       day...            exit    wk...            exit   mth...           exit   6mths...         exit   yr...            exit
HI: 1000 HI: 999.4 HI: 499.8 HI: 8.0 HI: NO DATA
                                                                                       USAGE: 1000/1068
                                                                                                      exit
                                                                                       USAGE: 7:45hrs            USAGE: 7:05hrs          USAGE: 6.55hrs          USAGE: 7:15hrs          USAGE: 7:20hrs
                                                                                       day...            exit    wk...            exit   mth...           exit   6mths...         exit   yr...            exit
Statistics are provided for five time intervals (last day, last week, last month, last six
months, last year) so you can assess the significance of recent events.
All statistics calculated for a range of dates are median values. The median is the middle
value after the data have been sorted in order (50% of the values are smaller and 50%
are larger). For example, Table 6 presents one week of 95th centile leak data (values
in L/s). On day 7, the value 0.30 L/s would be displayed as the most recent day’s leak
value. In column 3 of the table, the seven leak values have been sorted in increasing
order to calculate the median value.
Table 6: Sample calculation of median leak value
7 0.30 0.20
6 0.20 0.20
5 1.00 0.30
3 0.30 0.30
2 0.40 0.40
1 0.30 1.00
The median corresponds to the fourth value (0.30 L/s) in the ordered data set. The
value 0.30 L/s would be displayed as the most recent week’s leak value.
If the data set had included an even number of days (eg a 30-day month), the median
would be the average of the middle two values in the ordered data set.
Notes:
a. The median is a more robust measure than an average (or arithmetic mean) for a data
    set that has some extreme values. The average of the data in the above table is
    0.39 L/s, reflecting the single session that had unusually high leak (1.00 L/s).
b. You may make the Efficacy and Usage Data screens available to your patient by
    instructing them to press the Left and Right keys simultaneously. This does not give
    access to the other parts of the clinical menu.
The Erase Data feature in Clinical Menu, Options enables you to remove all efficacy
and usage data stored in the device (except Run Hours). Machine settings are not
affected.
       PRESSURE
         The pressure transducer located in the device measures treatment pressure; the
         average pressure is calculated and recorded each minute. The pressure reported in the
         Efficacy Data submenu (see Figure 7, The clinical menu results series, on page 28) for
         a single session is the 95th centile pressure for mask-on time, excluding periods when
         the leak has exceeded 0.4 L/s (24 L/min). For selected time intervals (last week, last
         month, last six months, or last year), the median of the daily 95th centile values is
         reported. Non-usage days are not included in calculations.
       LEAK
         Leak is derived by analyzing inspiratory and expiratory airflows (via the flow sensor
         located in the device). Theoretically, inspiratory and expiratory volumes should be
         equal. A net airflow greater than the expected mask vent flow is equal to the leak.
         Generally, a leak rate of more than 0.4 L/s (24 L/min) is associated with patient
         discomfort, disturbed sleep, and reduced efficacy of treatment.
         Notes:
         a. If the leak exceeded 0.4 L/s (24 L/min) for more than 30% of the previous session, the
            following message will appear on the LCD: High leak in last session.
         b. The Leak Alert feature, if enabled, will alert the patient when mask leak exceeds
            0.7 L/s (42 L/min) for more than 20 seconds.
         The leak reported in the Efficacy Data submenu (see Figure 7, The clinical menu results
         series, on page 28) is the 95th centile value for mask-on time for each session, or the
         median 95th centile value for a selected time interval (last week, last month, last 6
         months, or last year). Non-usage days are not included in calculations.
30
SMART DATA IN THE PATIENT MENU
    A SMART DATA feature has been incorporated in the S8 ELITE device to increase patient
    involvement in their therapy. Display of SMART DATA for the patient to review is at
    your discretion. Select some or all options for display in the patient menu from the
    SMART DATA submenu in Clinical Menu, Options (see Figure 5, Settings menu screens,
    on page 21). The following data can be made available, showing, for the most recent
    session:
    • the star rating of the 70th centile mask fit
    • 95th centile pressure
    • total duration of session (usage).
    Set the Mask Fit, Pressure, or Usage options to ON to enable the patient to see any
    or all of this data.
    If the Auto Appear option is set to OFF, the data will be displayed in the Results
    submenu of the patient menu only. If you (or the patient) set Auto Appear to ON, the
    data for the previous session will be displayed after the patient restarts the device.
    Data for the current session are available for display up until noon, when a new session
    commences.
    Note: If none of the Smart Data options (Mask Fit, Pressure, or Usage) has been set to
    ON in the clinical menu, the Results submenu is not displayed in the patient menu.
    Patients can use a Smart Data diary to monitor their therapy. You can download a PDF
    of the Smart Data diary for S8 ELITE from <www.resmed.com>.
34
USING THE MAILBACK ENVELOPE AND BUBBLE MAILER
  The Data Card slots into the mailback envelope to keep it safe while in transit or
  storage.
  Figure 8 shows the inside of the mailback envelope.
                                                                                                                                                                                          Write notes
                                                                                                                                                                                          here
                 COPY DATA
                 FR   COPIEZ LES DONNEES                ES   COPIADO DE DATOS                    PT   COPIAR DADOS
        1                                               2                                                 3                                              4
                                                                  CARD INSERTED                                       COPY COMPLETE
                                                                                                                                                                                          Instructions for
                                                                                                                                                                                          copying data
                                                                  Please wait                                         Remove card
                 UPDATE SETTINGS
                 FR   METTEZ LES REGLAGES A JOUR                       ES   ACTUALIZACIÓN DE LA CONFIGURACIÓN                                 PT   ACTUALIZAR PARÂMETROS
        1                                               2                                                 3                                              4
                                                                  CARD INSERTED
                                                                  Please wait
                                                                                                                      SETTINGS SUCCESS
                                                                                                                      Remove Card
                                                                                                                                                                                          Instructions for
                                                                 FR    CARTE INSEREE                            FR    CHARG.REUSSI
                                                                                                                                                                                          updating
                                                                       Patientez SVP                                  Retirez carte
                                                                 ES    TARJ. INSERTADA
                                                                       Espere
                                                                                                                ES    CONFIG CORRECTA
                                                                                                                      Quitar tarjeta
                                                                                                                                                                                          settings
                                                                 PT    CARTAO INSERI                             PT   PARAMET SUCCESSO
                                                                       Aguarde p.f.                                   Retirar cartão
                  If messages differ, see your manual. Use Data Card as per above before returning.
        !         Si les messages affichés sont différents, référez-
                  vous à votre manuel. Utilisez la carte de données
                                                                            Si los mensajes son distintos, consulte el manual.
                                                                            Antes de devolverla, utilice la tarjeta tal como se
                                                                                                                                      Se as mensagens forem diferentes, consulte o seu
                                                                                                                                      manual. Use o cartão de dados tal como é
                  conformément aux instructions ci-dessus avant de          indica.                                                   descrito acima antes de o devolver.
                  la retourner.
    6
                      Return by mail
                                                                                                                                  5                                                       Data Card
                      FR
                      ES
                           Retournez par courrier
                           Devolver por correo                                                                                                                                            goes here
                      PT   Devolva o cartão por correio
                      Return in person
                      FR   Retournez la carte personnellement
                      ES   Devolver en persona
                      PT   Devolva o cartão em pessoa
                      Keep the card
                      FR
                      ES
                           Gardez la carte
                           Conservar la tarjeta
                                                                                                                                                                                          Indicate what
                                                                                                                                                                                          you want the
                      PT   Fique com o cartão
  Use the mailback envelope for transporting and storing the Data Card. Place the
  mailback envelope containing the Data Card in the supplied bubble mailer when
  mailing the card. You can write your name and address details on the front of the
  bubble mailer to assist the patient in mailing it back to you. Use a postal envelope to
  mail the bubble mailer and its contents to the patient.
36
     Note: This message only appears once. If you re-insert the Data Card after you have
     updated your settings, this message is not displayed.
     4. Remove the Data Card from the device.
     This information is also supplied in the patient’s User’s Manual.
     When you create a Data Card with therapy settings you can store the serial number
     of the device on the Data Card. This prevents the settings from being applied to the
     wrong device. Refer to your PC application manual for more details.
     Compliance and efficacy data are always stored in the S8 ELITE. If a Data Card is lost
     or damaged in transit, data stored in the S8 device can be recopied onto a Data Card.
     WARNING
 !   Advise the patient to contact you immediately if they are using the Data Card to
     update the settings on their device and the “Settings Success” message does not
     appear.
S8 ADAPTERS
     S8 adapters are designed for use with the ResMed S8 series of devices, to transfer data
     between the device and a personal computer.
     Two adapters are available:
     • Serial adapter, which uses a standard serial cable
     • USB adapter (supplied with a USB cable).
     WARNING
 !   •   Only use S8 adapters as specified in this manual.
     •   S8 adapters are specifically designed for use with ResMed S8 devices.
     Attach the S8 serial or USB adapter to a ResMed S8 device to create a serial or USB
     port. You can then connect a cable that enables transfer of data between the device
     and a personal computer.
     CAUTION
 !   If a cable is not attached when an S8 adapter is attached to an S8 device, either
     attach the adapter’s protective cover, or remove the adapter and replace it with a
     blank or Data Card module. This is to prevent damage to the S8 adapter.
38
CLEANING AND MAINTENANCE
     You should regularly carry out the cleaning and maintenance described in this section.
     Refer to your mask manual for detailed instructions.
DAILY CLEANING
     Mask
     Clean the mask according to the instructions supplied with the mask.
     Air tubing
     Disconnect the air tubing from the S8 ELITE (and humidifier, if used) and hang the
     tubing and mask in a clean, dry place until next use.
     Humidifier
     If you are using a humidifier, clean it according to the instructions in the humidifier
     user’s manual.
WEEKLY CLEANING
     1. Remove the air tubing from the S8 ELITE and the mask.
     2. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang,
        and allow to dry.
     3. Before next use, assemble the mask and headgear according to the user
        instructions.
     4. Reconnect the air tubing to the air outlet and mask.
PERIODIC CLEANING
     1. Clean the exterior of the S8 ELITE with a damp cloth and mild liquid soap.
     2. Check the air filter for blockage or holes (see “Replacing the Air Filter” on
        page 40).
     WARNING
 !   • Beware of electric shock. Do not immerse the unit or power cord in water.
       Always unplug the unit before cleaning and be sure it is dry before plugging back
       in.
     • The mask system and air tubing are subject to normal wear and tear. Inspect
       them regularly for damage.
     SERVICING
          CAUTION
       !   • Do not attempt to open the S8 Elite case. There are no user serviceable parts
             inside.
           • Inspection and repair should only be performed by an authorized agent. Under
             no circumstances should you attempt to service or repair the flow generator
             yourself.
           This product (S8 ELITE) should be inspected by an authorized ResMed service center
           5 years from the date of manufacture. Prior to this, the device is intended to provide
           safe and reliable operation provided that it is operated and maintained in accordance
           with the instructions provided by ResMed. Applicable ResMed warranty details are
           provided with the device at the time of original supply. Of course, as with all electrical
           devices, if any irregularity becomes apparent, you should exercise caution and have the
           device inspected by an authorized ResMed service center.
           If you feel that your flow generator is not performing properly, see “Troubleshooting”
           on page 43.
40
FREQUENTLY ASKED QUESTIONS
   CAN PATIENTS USE THE S8 ELITE WITH A HUMIDIFIER?
   Yes. Patients may experience dryness of the nose, mouth and/or throat during the
   course of treatment, especially during winter. In many cases, a humidifier may resolve
   this discomfort. The S8 ELITE can be used with the HUMIDAIRE 3i to form an integrated
   device.
   WHAT IS EPR?
   EPR (expiratory pressure relief) is designed to help patients using the S8 ELITE who
   experience discomfort when breathing out against the set pressure. If you set EPR,
   there are three levels available (1–3 cm H2O). You can set EPR so that it is available
   either during ramping only, or throughout therapy. Use the EPR menu setting to give
   the patient access to EPR setting.
   HOW CAN I OBTAIN DATA OR MAKE DATA AVAILABLE TO A PATIENT?
   Both the clinician and the patient can view data on the S8 ELITE LCD screen. You can
   also use a Data Card to obtain patient data and update patient settings data remotely.
   You can use an S8 adapter and cable to transfer data directly between an S8 ELITE and
   a PC application.
   HOW LONG DOES THE PATIENT HAVE TO LEAVE THE DATA CARD IN THE S8 ELITE
   TO COLLECT DATA?
   The Data Card can be inserted at any time. Data in the S8 ELITE will be transferred to
   the Data Card within 30 seconds.
   HOW MUCH DATA CAN I OBTAIN FROM THE S8 ELITE?
   The S8 ELITE stores up to 365 days of summary data and up to five nights of detailed
   data (up to 500 events per session). The Data Card stores up to 180 days of summary
   data and up to five nights of detailed data (up to 200 events per session).
   CAN I SET REMINDERS FOR MY PATIENTS?
   You can set a series of reminders, to let patients know when to replace their mask or
   air filter, when to get their device serviced, when to use a Data Card or when to
   contact you. You can use a PC application to customize specific reminders.
   CAN PATIENTS TRAVEL WITH THE S8 ELITE?
   International use
   The S8 ELITE flow generator has an internal power supply that enables it to operate in
   other countries. It will operate on power supplies of 100–240 V and 50/60 Hz. No
   special adjustment is necessary, but patients may need a plug adapter for the power
   outlet.
42
TROUBLESHOOTING
     CAUTION
 !   If the problem cannot be solved, contact your equipment supplier or ResMed. Do
     not attempt to open the S8 Elite case. There are no user serviceable parts inside.
     Repairs and internal servicing should only be performed by an authorized service
     agent.
      Device does not start   Power cord is not connected    Connect power cord firmly
      when the patient        properly.                      at both ends.
      breathes into the
      mask.                   Power outlet may be faulty.    Try another power outlet.
                                                                      TROUBLESHOOTING       43
     Problem                  Possible Cause                     Solution
     Date or time in data     Date or time on device is          Correct the current time
     files is wrong.          wrong.                             and date on the device.
     Displays error           The air tubing is loose.           Check that the air tubing is
     message:                                                    properly connected.
     Check tube!!                                                To clear the message, press
     Key if done                                                 any key on the keypad.
44
Problem                  Possible Cause                      Solution
The Data Card is         Data Card was not inserted          Check that the patient is
returned without the     correctly.                          inserting the Data Card into
expected patient data.                                       the Data Card module with
                                                             the arrow facing up, while
                                                             the S8 Elite is powered and
                                                             not delivering therapy (in
                                                             standby mode).
                         The card is not a ResScan Data      Check that the card used is
                         Card.                               a ResScan Data Card.
The following message    Data Card is not inserted           Check that the patient is
is displayed on the      correctly.                          inserting the Data Card into
LCD after the patient                                        the Data Card module with
inserts a Data Card:                                         the arrow facing up, while
Card Error                                                   the S8 Elite is switched on
Remove Card                                                  and not delivering therapy
                                                             (standby mode).
                         The card is not a ResScan Data      Check that the card used is
                         Card.                               a ResScan Data Card.
                                                                       TROUBLESHOOTING         45
     Problem                   Possible Cause                      Solution
     The following message     The identification details on the   Check that the
     is displayed on the       Data Card do not match the          identification details on the
     LCD after the patient     identification details on the       Data Card are correct. (See
     tries to update the       device the patient is trying to     the clinician’s manual for
     settings using the Data   update.                             your PC application for
     Card:                                                         instructions.)
     Settings Invalid
     Remove Card
     The following message     The settings were not updated.      The message only appears
     is NOT displayed on                                           the first time a Data Card is
     the LCD after the                                             inserted into a device to
     patient tries to update                                       update settings. The patient
     the settings using the                                        may have missed seeing the
     Data Card:                                                    message.
     Settings Success                                              To check whether the
     Remove Card                                                   settings have actually been
                                                                   applied:
                                                                   • Ask the patient whether
                                                                     the therapy they are
                                                                     receiving feels different.
                                                                   • Check the settings data
                                                                     written on the Data Card
                                                                     from the S8 Elite to see if
                                                                     they are correct (refer to
                                                                     your PC application
                                                                     clinician’s manual for
                                                                     more information). If the
                                                                     settings data on the Data
                                                                     Card matches the
                                                                     intended settings the
                                                                     device has been
                                                                     programmed
                                                                     successfully.
46
Problem                 Possible Cause                     Solution
If the patient doesn’t feel any difference in therapy and/or the settings are not
correct, you need to consider the following possible causes:
                        The Data Card was removed          Check that the patient does
                        before settings were copied to     not remove the Data Card
                        the S8 Elite.                      before the
                                                           Settings Success
                                                           Remove Card message
                                                           appears on the LCD.
                        The card is not a ResScan Data     Check that the card used is
                        Card.                              a ResScan Data Card.
                                                                     TROUBLESHOOTING         47
48
SYSTEM SPECIFICATIONS
S8 ELITE (WITHOUT ACCESSORIES)
    Performance
    Operating pressure range: 4 to 20 cm H2O
    Dimensions (H x W x D): 4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm)
    Weight: 2.9 lb (1.3 kg)
    Power Supply
    • Input range for S8 ELITE with HUMIDAIRE 3i: 100–240 V, 50/60 Hz; 110 V, 400 Hz;
      2.5 A <140 VA (110 W) (maximum power consumption). Instantaneous peak
      power consumption <340 VA.
    • Refer to the DC-12 converter instructions for DC ratings. Only use the ResMed
      DC-12 converter for DC input.
    Actual power consumption will vary, depending on factors such as the use of
    accessories, height above sea level, and ambient temperature. Power consumption
    values for typical treatment conditions (using a breathing machine set to 0.5L and
    15 breaths/min with 6’6” (2 m) air tubing and an ULTRA MIRAGE mask) are given in the
    following table.
S8 Elite 5 18 7.6
10 23 11.6
15 30 15.9
20 39 20.7
ACCESSORIES
  DATA CARD
    Dimensions (L x W x D): 2.56” x 0.87” x 0.03” (65.04 mm x 22.15 mm x 0.85 mm)
                                                                 SYSTEM SPECIFICATIONS     49
       DATA CARD MODULE
         Dimensions (H x W x D): 1.95” x 1.66” x 0.47” (49.7 mm x 42.2 mm x 12 mm)
Type CF equipment
Class II equipment
Drip proof
Dangerous voltage
50
INDEX
A                              Run Hours 24
accessories 8                  serial number (device) 24
adapters                       Servicing Menu 24
   removing 38                 Settings Menu 22
   serial 37                   settings options 26
   USB 37                      Smart Data 23
air filter 49                  SmartStart 23
   replacing 40                software version 24
air tubing 49                  Start CPAP 22
   cleaning 39                 Time 24
aircraft 42                    Tube Length 23
apnea 30                       Usage Data 23
attaching an adapter 38        used days/total days 22
                               used hours 22
B                           clinical menu results
baud rate 24                   data 27
blank module 33             CPAP 22
                            CPAP menu 16
C                           customized reminders 26
call provider reminder 25
cleaning 39                 D
   daily 39                 daily cleaning 39
   periodic 39              data
   weekly 39                  clinical menu results 27
cleaning mask 39            Data Card 41
clinical menu 19              analyzing 37
   baud rate 24               copying data to 36
   CPAP 22                    inserting 36
   Date 24                    patient management 34
   Efficacy Data 23           removing 36
   EPR 23                     updating settings 36
   EPR Access 23            Data Card module 33
   EPR Setting 23           data management 27
   Erase Data 24, 29        data management products 8, 33
   Factory Defaults 23      date (setting) 24
   Humid 22                 DC-12 converter 42
   Language 24              default settings 26
   Leak Alert 23            delivering therapy 11
   Mask 22                  detailed data 41
   Max Ramp 22              down key 15
   Menu Type 24             dryness
   Mode 22                    mouth, nose, or throat 41
   Options menu 23
   parameters 22            E
   PCB number 24            Efficacy Data 23
   quick key access 16      electromagnetic compatibility 50
   Ramp 22                  environmental conditions 50
   Reminders 23, 25         EPR 41
   Results 27                  device performance 10
                                                               INDEX   51
       features 9                        Mode 22
       screens 23                        modules
     EPR Access 23                        blank 33
     EPR screens 23                       Data Card 33
     EPR Setting 23                      muffler 22
     Erase Data 24, 29
     expiratory pressure relief 9        O
                                         obstructive sleep apnea (OSA) 9
     F                                   obtaining data 41
     Factory Defaults 23                 operating information 7
     frequently asked questions 41, 42   Options menu 23
     front cap 22
                                         P
     H                                   patient management
     high leak message 30                  Data Card 34
     housing construction 50             patient menu 16
     HumidAire 3i 8                        Humid 22
       attaching 13                        Language 24
       storing 13                          Leak Alert 23
     humidifier 41                         Mask 22
       cleaning 39                         parameters 22
       type 8                              PCB number 24
     hypopnea 30                           Ramp 22
                                           Run Hours 24
     I                                     serial number (device) 24
     insert card reminder 25               settings options 26
     international use 41                  Smart Data 23, 31
     interpreting data 30                  SmartStart 23
                                           software version 24
     K                                     Tube Length 23
     keypad 15                           periodic cleaning 39
                                         power sources 42
     L                                   power supply 49
     Language 24                         principles of operation 9
     LCD screen 15                       printed circuit board number 24
     Leak Alert 23
     left key 16                         Q
                                         quick key access
     M                                     clinical menu 16
     machine hours 24
     mailback envelope 35                R
     mask 22                             Ramp 22
       available masks 7                 reminders 23, 25, 41
       mask-fit 13                         call provider 25
     mask settings 24                      customized 26
     mask types 24                         insert card 25
     maximum ramp 22                       replace air filter 25
     median values 29                      replace mask 25
     medical information 3                 service due 26
     Menu Type 24                        removing an adapter 38
     menus 16                            replace air filter reminder 25
52
replace mask reminder 25        using Data Card 36
responsibility, user/owner 1
Results 27                      W
right key 16                    weekly cleaning 39
Run Hours 24                    weight 49
S
S8 adapter 41
   dimensions 50
   serial 37
   USB 37
S8 adapters
   removing 38
S8 Elite 7
   dimensions 49, 50
   servicing 40
   travelling with 41
serial adapter 37
serial number 24
service due reminder 26
Servicing Menu 24
Settings Menu 22
Smart Data 23
   displaying patient data 31
   patient menu 31
SmartStart 11, 23
software version 24
star ratings, mask fit 13
Start CPAP 22
start/stop key 15
statistics
   median values 29
summary data 41
system specifications
   S8 Elite 49
T
time (setting) 24
troubleshooting 43
Tube Length 23
U
up key 15
updating device settings 36
Usage Data 23
USB adapter 37
use on aircraft 42
used hours 22
Used screen
  clinical menu 27
user/owner responsibility 1
                                                     INDEX   53
54