Product Manual Ebb Therapeutics, Inc.
Ebb Therapeutics Table of Contents Introduction 3 Warnings 4 Cautions 6 Device Description 8 Before First Use 9 Setup 10 Connect Headband 11 Insert Fluid Cartridge 12 Connect Power Supply 13 Display 14 Set the Clock 15 Select Temperature 18 Applying Headband 19 Tube Placement 20 Cleaning 21 Replacing the Fluid Cartridge 22 Service Life / Disposal 23 Troubleshooting 24 Technical Description 26 Symbols / FCC Rules 34 Limited Warranty 35 2 Congratulations! You’re taki
! WARNING Warnings alert the user about situations that could result in injury or death if not avoided. • Read the entire manual before use. • Some individuals may experience skin redness on the forehead after wearing the forehead pad. If this persists more than 12 hours, contact Ebb Customer Care. • The headband must be worn in the proper orientation to prevent entanglement and strangulation. • The headband must be routed above the pillow to prevent entanglement and strangulation.
! CAUTION Cautions alert the user to important information regarding use of Ebb. • Improper placement of the headband 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 Therapeutics to assure proper performance. Make sure the fluid cartridge is in the bedside controller before initial use. • Do not expose Ebb to temperatures below freezing as fluid could freeze and damage the device.
Ebb Device Description Before First Use Unpack and familiarize yourself with Ebb. Ebb is the first smart-technology and drug-free wearable device that uses a proprietary cooling headband 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. Ebb includes a bedside controller, headband, fluid cartridge, and power supply.
1 Set Up 2 Connect Headband Place the bedside controller on a hard, flat surface at the height of your pillow and near a wall outlet. Always place the bedside controller on a hard, flat surface in a well-ventilated area. Keep the vents clear of obstructions. ! WARNING: • Ebb should not be used close to or stacked with other electrical equipment. Insert headband to back of bedside controller until you feel it click. Tug firmly on the headband tubing to make sure it is inserted correctly.
3 Insert Fluid Cartridge 4 Remove orange cap from fluid cartridge before inserting. Open lid. Hold down and turn to lock position. Knob is in locked position. Wait 30 seconds before using bedside controller. Insert fluid cartridge and hold down. CAUTION: Use only fluid cartridges provided by Ebb Therapeutics to assure proper performance. Make sure the fluid cartridge is in the bedside controller before initial use. 12 Connect Power Supply Plug the end of the p ower cord into the power s upply.
Display 5 When in use at night, the display disappears. Rotate the dial to wake the display. When the clock is displayed, rotate counter-clockwise to dim the display and clockwise to make it brighter. Clock/Alarm Buttons set set clock on/off on/off alarm gentlewake 00:00 replace Set the Clock am pm Dial Open lid to access clock buttons. Press and release the “Set Clock” button. Time Gentlewake Warmer Cooler 00:00 replace am pm 6:00 7:00 7:35 7:35 Alarm The hours begin blinking.
6 Set Wake Time 7 Turn on Gentlewake 7:00 Open lid to access clock buttons. Press and release the “Set Alarm” button. The hours begin blinking. Turn dial to set hour with AM or PM. Open lid to access clock buttons. 8:30 am The Gentlewake feature turns off the cooling therapy 30 minutes before the wake up time you set. 7:30 7:35 Press set alarm button to select minutes. Press “Gentlewake on/off” button. A sun icon will appear when the Gentlewake feature is on.
9 Select Temperature 10 Cooler When the device is on, turn the dial to the desired profile setting. P1 (coldest) P10 (warmest). The display shows the letter “P”, for Temperature Profile, along with a number between 1-10, where 1 is coldest and 10 is warmest. Applying Headband Warmer As you turn the dial to make warmer, an orange up arrow appears, to make cooler, a blue down arrow appears. It could take up to 10 minutes to reach the temperature for the selected profile.
Tube Placement Ebb Therapeutics recommends running the tubing between your mattress and headboard (or wall) to help hold the tubing when moving around during sleep. If you prefer a quiet background in your bedroom, you can use ear plugs to complement Ebb. Cleaning The bedside controller can be wiped down with an alcohol wipe. Allow the bedside controller to dry completely before plugging in the power cord.
11 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. Service Life Disposal The expected service life of the Ebb system is 3 years. If the device stops cooling or circulating the fluid or begins to leak, it is time to replace the device.
Troubleshooting Problem If there is a problem, first try the following suggestions. There are no user-serviceable components inside the device. Do not attempt to open the bedside controller. This will void the warranty. Ebb Customer Care: 800-381-1145 Problem Solution Controller not turning on Power is not connected Ensure the power supply is connected to the power outlet. Power cord is partially inserted into the bedside controller. Fully insert the power cord.
Technical Description Specification 26 Specification Rated voltage 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° C to +24° C (57°F to 75°F) Note: Usage above 24°C (75°F) may impact the time to reach temperature set point.
Electromagnetic Compatibility Ebb complies with all applicable electromagnetic compatibility requirements (EMC) IEC 60601-1-2 4th edition and meets the Class B Group 1 emissions requirements in CISPR 11. Ebb has met the Home Healthcare Immunity requirement levels.
Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity 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. 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.
Guidance and manufacturer’s declaration – electromagnetic immunity 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.
Symbols Manufacturer name, address and location Serial number of the device Accompanying documentation includes important information on product use ! Warning or Precaution Statement For Indoor Use Only Keep Dry Type BF Applied Part Manufacturing Date Code Reference Part Number 34 FCC Rules Limited Warranty Information for Users of FCC Part 15, Class B Devices Ebb Therapeutics Inc.
