ResMed 248551/1 マニュアル

目次

• Contents

  4
• Introduction

  6
  • Indications for use

    6
  • Contraindications

    6
  • Adverse effects

    6
• Stellar at a glance

  7
  • Handle

    7
  • Patient interface

    8
  • Humidification

    8
  • Internal battery

    8
  • ResMed USB stick

    8
  • Use on an aircraft

    8
  • Mobile use

    9
• Setting up for noninvasive use

  9
  • • ResMed recommends using the AC power cord supplied with the unit. If a replacement power cord is required, contact your ResMed Service Centre.

    9
  • • Place the device on a flat surface near the head of the bed.

    9
    • AC locking clip

      9
  • Attaching the H4i heated humidifier for noninvasive use

    10
    • • A humidifier increases resistance in the air circuit and may affect triggering and cycling, and accuracy of display and delivered pressures. Therefore perform the Learn Circuit function (see “Setup menu: Options” on page 16). The device adjus...

      10
    • • The heating feature of the H4i is disabled when the device is not mains powered.

      10
• Setting up for invasive use

  10
  • Antibacterial filter

    11
• Working with other optional accessories

  12
  • Attaching the pulse oximeter

    12
  • Adding supplemental oxygen

    12
    • Oxygen supply

      13
  • Starting therapy using oxygen

    13
  • Stopping therapy using oxygen

    13
  • Using the FiO2 monitoring sensor

    13
  • Attaching an antibacterial filter

    14
• Stellar basics

  15
  • About the control panel

    15
    • Mains Power LED

      15
    • On when operating on mains power.

      15
  • LCD screen

    16
    • Warm-up feature H4i

      16
• Starting therapy

  16
  • Performing a functional test

    16
    • Warm-up humidifier

      17
  • Starting therapy

    17
  • Stopping therapy

    17
    • • SmartStop may not work if Full face or Trach is selected as mask type; the High Leak alarm or the Low Min Vent alarm is enabled; “Confirm Therapy Stop“ is enabled; or the mask-fitting feature is running.

      17
    • • When the device is stopped and operating in standby mode with an integrated humidifier connected, it will continue to blow air gently to assist cooling of the humidifier’s heater plate.

      17
    • • Masks with high resistance (eg, paediatric masks) may cause the operation of the SmartStop feature to be restricted.

      17
    • • When using with oxygen, turn off oxygen flow before stopping therapy.

      17
  • Turning off the power

    18
  • Working with alarms

    18
    • Alarm message

      18
  • Tailoring treatment setup options

    19
    • Ramp time

      19
    • Program

      19
  • Using mask-fit

    19
    • • Press for at least three seconds during mask-fit to start the treatment immediately.

      19
    • • The mask-fitting feature is disabled when the mask type Trach is selected.

      19
• Using the menus

  20
• Setup menu

  21
  • Setup menu: Clinical Settings (Mask Type)

    21
  • Setup menu: Alarm Settings (Alarm Volume)

    21
  • Setup menu: Options

    21
    • 1. If in use, turn off the oxygen flow.

      22
    • 2. Select the mask type.

      22
    • 3. Set up the air circuit including accessories and patient interface.

      22
    • Note: For invasive use, do not connect a catheter mount, tracheostomy tube or HMEF, see “Setting up for invasive use” on page 5).

      22
      • 4. Leave the air circuit unobstructed and open to the air.

        22
      • 5. Press to start the Learn Circuit.

        22
      • 6. Wait for the device to complete its automated tests (<30 sec). The results are displayed when complete. If the circuit configuration has been successfully learnt, displays. If unsuccessful, displays (see “Troubleshooting” on page 21).

        22
      • 1. Press to start the FiO2 sensor calibration.

        22
      • 2. Wait for the device to complete its calibration.

        22
  • Setup menu: Configuration Menu

    22
• Info menu

  23
  • Event Summary

    23
  • Used Hours

    23
  • Device Information

    23
  • Reminders

    23
• Data management

  24
  • • You cannot connect two ResMed USB sticks simultaneously for data communication.

    24
  • • If data transfer is not possible or failed please read the troubleshooting section.

    24
  • • Do not store files on the USB stick other than those created by the device or application. Unknown files may be lost during data transfer.

    24
• Cleaning and maintenance

  24
  • Daily

    24
  • Weekly

    25
  • Monthly

    25
  • Replacing the air filter

    25
    • .

      25
  • Disinfection

    25
  • Multipatient use

    26
    • 1. Apply undiluted mikrozid® AF or CaviCide® liquid to a clean non-dyed disposable cloth.

      26
    • 2. Wipe all surfaces of the device, including the air outlet; avoid liquid entering any openings in the device.

      26
    • 3. Leave the disinfectant to work for five minutes.

      26
    • 4. Wipe residual disinfectant from the device with a clean, dry non-dyed disposable cloth.

      26
  • Servicing

    26
• Troubleshooting

  26
  • Alarm troubleshooting

    26
    • • The alarm log and alarm settings are maintained when the device is powered down and in the event of a power loss.

      26
    • • If multiple alarms are active simultaneously, the alarm with the highest priority will be displayed first.

      26
    • • If an alarm activates repeatedly, discontinue use and return the device for servicing.

      26
      • 1. Power-off the device.

        27
      • 2. Power-on the device again.

        27
      • 1. Power-off the device.

        27
      • 2. Power-on the device again.

        27
      • 1. Power-off the device.

        27
      • 2. Check that the air tubing is connected properly.

        27
      • 3. Power-on the device again.

        27
      • 4. Start Learn Circuit function.

        27
      • Note: If the alarm activates repeatedly internal components may be defective. Discontinue use and return the device for servicing.

        27
        • 1. Check the air path for any blockages.

          27
        • 2. Remove the blockages.

          27
        • 3. If the alarm is not cleared, stop treatment.

          27
        • 4. Re-start treatment.

          27
        • 1. Stop treatment.

          27
        • 2. Re-start treatment.

          27
        • 1. Check the air circuit integrity and reconnect.

          27
        • 2. If the alarm doesn‘t get cleared, stop treatment.

          27
        • 3. Re-start treatment.

          27
        • 1. Check that the air tubing is connected properly to the humidifier or the device.

          28
        • 2. If the alarm is not cleared, stop treatment.

          28
        • 3. Re-start treatment.

          28
  • Other troubleshooting

    29
• Technical specifications

  31
  • • The manufacturer reserves the right to change these specifications without notice.

    33
  • • Pressure may be displayed in cm H2O or hPa.

    33
  • Guidance and manufacturer’s declaration – electromagnetic emissions and immunity

    33
    • The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

      33
    • RF emissions CISPR11

      33
    • Group 1

      33
    • The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

      33
    • RF emissions CISPR 11

      33
    • Class B

      33
    • The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage network that supplies buildings used for domestic purposes.

      33
    • Harmonic Emissions

      33
    • IEC 61000-3-2

      33
    • Class A

      33
    • Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

      33
    • Complies

      33
    • Warnings: The device should not be used adjacent to or stacked with other equipment.

      33
    • If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.

      33
    • The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may result in increased emissions or decreased immunity of the device.

      33
    • The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

      33
    • Electrostatic discharge (ESD) IEC 61000-4-2

      33
    • ±6 kV contact ±8 kV air

      33
    • ±6 kV contact ±8 kV air

      33
    • Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

      33
    • Electrical fast transient/burst

      33
    • IEC 61000-4-4

      33
    • ±2 kV for power supply lines

      33
    • ±1 kV for input/output lines

      33
    • ±2 kV

      33
    • ±1 kV

      33
    • Mains power quality should be that of a typical commercial or hospital environment.

      33
    • Surge IEC 61000-4-5

      33
    • ±1 kV differential mode

      33
    • ±2 kV common mode

      33
    • ±1 kV differential mode

      33
    • ±2 kV common mode

      33
    • Mains power quality should be that of a typical commercial or hospital environment.

      33
    • Voltage dips, short interruptions and voltage variations on power supply input lines

      34
    • IEC 61000-4-11

      34
    • <5% Ut (>95% dip in Ut) for 0.5 cycle

      34
    • 40% Ut (60% dip in Ut) for 5 cycles

      34
    • 70% Ut (30% dip in Ut) for 25 cycles

      34
    • <5% Ut (>95% dip in Ut) for 5 sec

      34
    • < 12 V (>95% dip in 240V) for 0.5 cycle

      34
    • 96 V (60% dip in 240 V) for 5 cycles

      34
    • 168 V (30% dip in 240 V) for 25 cycles

      34
    • <12 V (>95% dip in 240 V) for 5 sec

      34
    • Mains power quality should be that of a typical commercial or hospital environment.

      34
    • If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power source.

      34
    • Power frequency (50/60 Hz) magnetic field

      34
    • IEC 61000-4-8

      34
    • 3 A/m

      34
    • 3 A/m

      34
    • Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

      34
    • Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

      34
    • Recommended separation distance:

      34
    • Conducted RF IEC 61000-4-6

      34
    • 3 Vrms 150 kHz to 80 MHz

      34
    • d = 1.17 ÖP

      34
    • Radiated RF IEC 61000-4-3

      34
    • 10 V/m

      34
    • 80 MHz to 2.5 GHz

      34
    • d = 0.35 ÖP 80 MHz to 800 MHz

      34
    • d = 0.70 ÖP 800 MHz to 2.5 GHz

      34
    • where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

      34
    • Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

      34
    • NOTE 1: Ut is the AC mains voltage prior to application of the test level.

      34
    • NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.

      34
    • NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

      34
    • a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the...

      34
    • b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

      34
    • The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF c...

      34
    • Rated maximum output power of transmitter (W)

      34
    • 150 kHz to 80 MHz

      34
    • d = 1.17 ÖP

      34
    • 80 MHz to 800 MHz

      34
    • d = 0.35 ÖP

      34
    • 800 MHz to 2.5 GHz

      34
    • d = 0.7 ÖP

      34
    • 0.01

      34
    • 0.17

      34
    • 0.04

      34
    • 0.07

      34
    • 0.1

      34
    • 0.37

      34
    • 0.11

      34
    • 0.22

      34
    • 1.17

      34
    • 0.35

      34
    • 0.7

      34
    • 3.69

      35
    • 1.11

      35
    • 2.21

      35
    • 11.70

      35
    • 3.50

      35
    • 7.0

      35
    • For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of ...

      35
    • NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

      35
    • NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

      35
  • Symbols

    35
    • Follow instructions for use; Class II equipment; Type BF equipment;

      35
    • IP31 Device is protected against solid foreign objects of 2.5 mm diameter and greater and vertically falling water drops; Caution; Standby or preparatory state for a part of equipment; Connection for oxygen supply; max 30 l/min (max 30 L/min); Data p...

      35
• General warnings and cautions

  35
  • • The above are general warnings and cautions. Further specific warnings, cautions and notes appear next to the relevant instructions in the user guide.

    36
  • • Only trained and authorised personnel are allowed to make clinical setting changes.

    36
• Limited warranty

  37