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Use and Care Manual

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Summary of Contents for Fisher & Paykel ICON +

  • Page 1 Use and Care Manual...
  • Page 2: Table Of Contents

    BEFORE YOU START USA Federal Law restricts this device for sale by or on the order of a physician. Please read this guide before use and save instructions for future reference. Section 2 contains important safety information about the use of this device. The device is suitable for continuous operation. If you feel that your device or any accessories are not operating correctly, please contact your healthcare provider.
  • Page 3: Section 1 - Quick Start Information

    SECTION 1 - QUICK START INFORMATION 1. GETTING STARTED Place the device on a level surface, level with or below head height, to prevent water entering the tubing and the device enclosure. Plug the power cord into the power supply. Remove the Chamber Lid and reach inside the Water Chamber with your fingers to take hold of the circular chamber grip.
  • Page 4 When the Chamber Lid is locked into place, it should be flush, with no gaps for air to leak. It can now be used as a handle for lifting and carrying. The Chamber Lid can be unlocked by twisting in an anti-clockwise direction, then removed by lifting away from the device.
  • Page 5: F&P Icon Menu System

    2. F&P ICON MENU SYSTEM Simple Mode The Simple Mode is the default Menu System of the F&P ICON.* * Not in all models 1. On/Off and Ramp • A quick press to the SmartDial will start therapy. • To activate Ramp, press the SmartDial again and hold for 3 seconds. The Ramp symbol will appear 2. Humidity • To control the level of humidity delivered to the mask, turn the SmartDial to select the desired humidity level from 0 (off ) to 7 (maximum).
  • Page 6: Advanced Mode

    Advanced Mode The Advanced Mode is a menu system for users that provides additional features which are not available in Simple Mode. (Note: This mode may be restricted by your healthcare provider.) 4. On/Off and Ramp • A quick press to the SmartDial will start therapy. • To activate Ramp, press the SmartDial again and hold for 3 seconds. The Ramp symbol will appear 5.
  • Page 7: Alarm Time

    2. F&P ICON MENU SYSTEM (continued) • If AlarmTunes is selected, turn the SmartDial to select the desired music track (from 1 to 5, depending on how many songs are loaded onto the InfoUSB), or if there are two or more songs loaded select Auto for shuffle and press again to accept the change. Refer to the F&P Studio CD for instructions to install and transfer music to your InfoUSB.
  • Page 8: Sleep Data

    11. Sleep Data Turn the SmartDial to the Sleep Data setting and press to enter. Alternatively, press and hold the SmartDial for 7 seconds. Turn the SmartDial to either the Centers for Medicare and Medicaid (CMS) Report (US specific) or Patient Report and press to enter.
  • Page 9: 13I. Flight Mode

    2. F&P ICON MENU SYSTEM (continued) 13i. Flight Mode Flight Mode allows for the device to operate on a reduced power (75 W). Situations for use in this mode might include long-haul air flights and camping. NOTE: Humidity output will be significantly reduced in this mode and is not recommended for long-term use.
  • Page 10: Communicating Sleep Data

    3. COMMUNICATING SLEEP DATA • The USB Port houses the InfoUSB 2 which records patient compliance, efficacy and flow data. The InfoUSB 2 must be pushed completely into the USB Port until it clicks into place. To remove, push the end of the InfoUSB 2 for a spring-release retrieval. • The InfoUSB 2 is used to record sleep data from the device memory when it is inserted into the USB Port of the device and to store music for use with AlarmTunes.
  • Page 11: Cleaning And Maintenance

    4. CLEANING AND MAINTENANCE The device should be cleaned as follows: • Ensure the wall power outlet is turned off before unplugging the device from the power supply where appropriate. • Wipe the exterior and basin of the device (when the Water Chamber has been removed) with a clean, damp (not wet) cloth and mild dishwashing detergent. Do not use harsh abrasives, solvents or alcohol as these may damage the device. Daily Clean the Water Chamber, Chamber Lid and the Breathing Tube: • Unlock the Chamber Lid by twisting in the anti-clockwise direction and lift it away from the device.
  • Page 12: Section 2 - Other Product Information

    SECTION 2 - OTHER PRODUCT INFORMATION 1. INTENDED USE The device is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. 2. SYMBOL DEFINITIONS Alternating Current Type BF Applied Part ATTENTION Class II Medical Electrical Equipment...
  • Page 13 3.2.2 To avoid choking, or inhalation of a foreign object: • Never place any non-approved objects into any opening of the device, Breathing Tube or mask. • Ensure the recommended filter is fitted to the device before use. • Ensure the Breathing Tube is positioned so it can not become entangled with the body or furniture during sleep. 3.2.3 To avoid burns: • Do not fill the Water Chamber with hot water. • After use, wait for the water to cool before touching, carrying or emptying the Water Chamber. • Do not touch the heater-plate shortly after the device has been operating. • Do not touch the water in the Water Chamber while the device is operating. • Position the ThermoSmart Breathing Tube so it is uncovered and free from bedding or other materials. Do not lie on it and avoid prolonged skin contact. 3.2.4 Other: • Ensure the device is stored and operated on a surface, level or below head height, to prevent water entering the tubing and the device enclosure.
  • Page 14: Cautions

    3.2.6 Using supplemental oxygen with your device: • Supplemental oxygen can be administered at the mask end of the Breathing Tube or with an Oxygen Elbow. NOTE: At a fixed flow rate of supplemental oxygen the inhaled oxygen concentration will vary, depending on the pressure settings, the patient’s breathing pattern, mask selection and leak rate. • Ensure there is no obstruction downstream of the Oxygen Port as this can affect the delivered oxygen concentration.
  • Page 15: Product Specifications

    4. PRODUCT SPECIFICATIONS DIMENSIONS: 6.3 H x 6.7 W x 8.7 D in. (160 H x 170 W x 220 D mm) WEIGHT: 4.8 lb (2.2 kg) Packed Weight 8.7 lb (4.0 kg) PERFORMANCE: Pressure Range: 4 to 20 cmH O/hPa (in the unlikely event of fault conditions, pressure may reach up to 29 cmH Maximum Flow Rates...
  • Page 16 Static Pressure Stability Auto/Premo Novo Pressure change (cmH O) at connection port at a pressure setting of 10 cmH Humidity With ThermoSmart Breathing Tube 36 mg/L Body Temperature and Pressure Saturated (BTPS), 82% RH at 10 cmH O, with Maximum Humidity Humidity level 7 and Boost level high.
  • Page 17: F&P Icon Models And Features Matrix

    5. F&P ICON MODELS AND FEATURES MATRIX Performance Features Auto Premo Novo Fully Integrated • • • ThermoSmart Technology* • • • Auto-Adjusting Pressure • Efficacy Reporting • • Compliance Reporting • • • InfoUSB • • • SensAwake • •...
  • Page 18: Troubleshooting

    8. TROUBLESHOOTING If you feel that your device is not operating correctly, please refer to the following suggestions. If the problem persists, please consult your healthcare provider. Do not attempt to repair the device yourself. Problem Possible Cause Solution I can not turn the The device is likely to be in the Advance Turn the selection circle to the 12 o’clock pressure on or off...
  • Page 19 Manufacturer Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland 2013, PO Box 14 348, Panmure, Auckland 1741, New Zealand Tel: +64 9 574 0100 Fax: +64 9 574 0158 Email: info@fphcare.co.nz Web: www.fphcare.com Australia Fisher & Paykel Healthcare Pty Limited, 36-40 New Street, PO Box 167, Ringwood, Melbourne, Victoria 3134, Australia Tel: +61 3 9879 5022 Fax: +61 3 9879 5232 Austria Tel: 0800 29 31 23 Fax: 0800 29 31 22 Benelux Tel: +31 40 216 3555 Fax: +31 40 216 3554 China Tel: +86 20 3205 3486 Fax: +86 20 3205 2132 France Tel: +33 1 6446 5201 Fax: +33 1 6446 5221 Germany Tel: +49 7181 98599 0 Fax: +49 7181 98599 66...

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