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Ebb 900-00007 Product Manual

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Product 900-00007

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Summary of Contents for Ebb 900-00007

  • Page 1 Product Manual Product 900-00007...

  • Page 2: Table Of Contents

    Ebb Sleep Table of Contents Introduction Warnings Cautions Ebb Description Before First Use Setup Connect ComfortBand Insert Fluid Cartridge Connect Power Supply Display Set the Clock Select Temperature Applying ComfortBand Tube Placement Cleaning Replacing the Fluid Cartridge Service Life / Disposal...

  • Page 3: Introduction

    Ebb. Ebb is based on extensive clinical data and 20+ years of sleep imaging research. Relief from sleeplessness can take time and commitment.

  • Page 4: Warnings

    ComfortBand uncomfortable, please check with your doctor before use. • Do not use Ebb if the package or any part is damaged. Contact Ebb HumanCare. • Route the electrical cord to prevent a tripping hazard or being...
  • Page 5 Otherwise, degradation of the • Do not place Ebb Bedside Controller on the floor where it can be performance of this equipment could result. bumped or where someone is likely to trip over the power cord.

  • Page 6: Cautions

    Cautions alert the user to important information regarding use of Ebb. • Improper placement of the ComfortBand can result in reduced therapy. • The safety and effectiveness of Ebb in pregnant women has not been established. • Use only fluid cartridges provided by Ebb Sleep to assure proper performance.
  • Page 7 To Help You Get Started with Ebb • For support please contact Ebb HumanCare at (800) 381-1145.

  • Page 8: Ebb Description

    Ebb Description Ebb with PrecisionCool™ Technology is the first drug-free wearable solution that uses a proprietary cooling ComfortBand to naturally trigger a reduction in brain activity, which quiets the racing mind to help people with sleeplessness to fall asleep faster and get in to deeper stages of more restorative sleep faster.

  • Page 9: Before First Use

    ComfortBand Connector Selection Dial Power Connector Front of Bedside Controller Back of Bedside Controller WARNING: Do not use Ebb if the package or any part is damaged. Contact the Ebb HumanCare Team. CAUTION: Ebb is designed for indoor use only.

  • Page 10: Setup

    Keep the power supply away from hot surfaces. • Ebb is isolated from the mains by means of the supplied medical grade power supply. Do not use a power supply other than the one supplied with the system.

  • Page 11: Connect Comfortband

    Connect ComfortBand Insert ComfortBand to back Tug firmly on the ComfortBand of Bedside Controller until connector to make sure it is you feel it click. inserted correctly. CAUTION: Before each use, make sure the ComfortBand is properly connected to the back of the Bedside Controller.

  • Page 12: Insert Fluid Cartridge

    Knob is in locked position. lock position. Wait 30 seconds before using Bedside Controller. CAUTION: Use only fl uid cartridges provided by Ebb Sleep to assure proper performance. Make sure the fl uid cartridge is in the Bedside Controller before initial use.

  • Page 13: Connect Power Supply

    Bedside Controller. intentionally snug. The power supply is installed correctly when you can no longer see the metal portion of the connector. WARNING: Do not use Ebb if the package or any part is damaged. Contact the Ebb HumanCare Team.

  • Page 14: Display

    Display When in use at night, the display disappears. Rotate the dial to wake the display. When the clock is displayed, rotate counter-clockwise Clock/Alarm Buttons on/off on/off to dim the display and clockwise to make clock alarm gentlewake it brighter. 00:00 replace Dial...

  • Page 15: Set The Clock

    Set the Clock Press and release the “Set Clock” button. Open lid to access clock buttons. 7:00 7:35 6:00 7:35 The hours begin blinking. Press the “Set Clock” button. Turn dial to the correct minute. Press “Set Clock” button to set Turn dial to correct hour with The minutes will begin to blink.
  • Page 16 Set Wake Time 7:00 The hours begin blinking. Turn Open lid to access clock buttons. Press and release the “Set Alarm” button. dial to set hour with AM or PM. 7:30 7:35 Press “Set Alarm” button to Turn dial to set minutes for Press the “Set Alarm”...
  • Page 17 Open lid to access clock buttons. GentleWake feature is on. The GentleWake feature turns off the cooling therapy 30 minutes before the wake up time you set. Turning Ebb On and Off Push and hold dial to turn the device “ON” or “OFF”...

  • Page 18: Select Temperature

    Select Temperature Cooler Warmer When Ebb is on, turn the dial to the The display shows the letter “P”, for As you turn the dial to make warmer, an desired profile setting. P1 (coldest) - Temperature Profile, along with a number orange up arrow appears, to make cooler, P10 (warmest).

  • Page 19: Applying Comfortband

    WARNING: • Some individuals may experience skin redness on the forehead after wearing the ComfortBand. If this persists more than 12 hours, contact Ebb HumanCare. • The ComfortBand must be worn in the proper orientation to prevent entanglement and strangulation.

  • Page 20: Tube Placement

    Ebb. WARNING: The ComfortBand must be worn in the proper orientation and the tubing must be routed above the pillow to prevent entanglement and strangulation. Improper routing could cause a kink in tubing and cause Ebb to not function properly.

  • Page 21: Cleaning

    To avoid electrical shock, always unplug the power cord from the wall before cleaning Ebb. WARNING: Do not drop or place Ebb in any fluids. Do not allow any fluids to enter the openings of Ebb. Precaution: If you notice a change in functioning of Ebb, please contact Ebb HumanCare.

  • Page 22: Replacing The Fluid Cartridge

    Replacing the Fluid Cartridge The circulating fluid in Ebb naturally evaporates. After about three months of use, the fluid needs to be replenished by inserting a new fluid cartridge. When the fluid gets low, the water drop icon appears on the left side of the display.

  • Page 23: Service Life / Disposal

    Service Life Disposal The expected service life of Ebb is 3 years. If the device stops Separate collection for electrical and electronic equipment per cooling or circulating the fluid or begins to leak, it is time to replace EC Directive 2002/96/EC. Dispose of Ebb in accordance with the product.

  • Page 24: Troubleshooting

    Ensure the selection dial is held for 2 seconds to power on the device Error Message “85” and Ebb Shuts Down Ebb has been left in a cold environment Allow Bedside Controller to warm up before re-use. Disconnect power and then reconnect to restart Bedside Controller.
  • Page 25 Bedside Controller. There is a problem with the Bedside Controller Disconnect the power cord and then plug back in. If error code repeats, contact Ebb HumanCare for additional support. Error Message “88” or “82” and...

  • Page 26: Technical Description

    AC Power Input 100-240V, 50/60Hz 1.2A DC Power 12VDC 7.5A Fuses: There are no user-replaceable fuses Isolation from Supply Mains Ebb is isolated from the mains by means of the supplied medical grade power supply. Rated Power 90 Watts Ambient Temperature (Operating) +14°...
  • Page 27 Specification Ebb was tested to IEC 60601-1 Medical Equipment – General Requirements for Safety Type of Protection Against Electric Shock: Class II Equipment Degree of Protection Against Electric Shock: Type BF Applied Part Degree of Protection against Ingress of Water: Keep Dry...
  • Page 28 Portable radio frequency communications equipment (including items such as antenna cables and external antennas) should be used no closer than 12 inches to any part of Ebb, including cables specified by the manufacturer. Otherwise, loss of the performance of this equipment could result.
  • Page 29 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Ebb is intended for use in the electromagnetic environment specified below. The customer or the user of Ebb should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 30 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Ebb is intended for use in the electromagnetic environment specified below. The customer or the user of Ebb should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level...
  • Page 31 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Ebb is intended for use in the electromagnetic environment specified below. The customer or the user of Ebb should assure that it is used in such an environment. IMMUNITY test IEC 60601 TEST LEVEL...
  • Page 32 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Ebb is intended for use in the electromagnetic environment specified below. The customer or the user of Ebb should assure that it is used in such an environment. IMMUNITY test IEC 60601 TEST LEVEL...
  • Page 33 Ebb Ebb is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Ebb can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Ebb as recommended below, according to the maximum output power of the communications equipment.

  • Page 34: Symbols / Fcc Rules

    Symbols FCC Rules Information for Users of FCC Part 15, Class B Devices Manufacturer name, address and location Compliance This equipment has been tested and found to comply with the limits for Serial number of the device a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 35: Limited Warranty

    Ebb: one (1) year from the date of purchase by the end user (Bedside Controller only) If the Product fails under normal conditions of use and the Product is returned to Ebb Sleep within the Warranty Period, Ebb Sleep will repair or replace the defective Product with a new or refurbished Product, at Ebb Sleep’s sole discretion.
  • Page 36 Ebb Therapeutics, Inc. 2555 Smallman Street, Suite 100 Pittsburgh, PA 15222 Phone: (800) 381-1145 © 2019 Ebb Therapeutics 441-00022 Revision F...

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