Electromed SmartVest Clearway Instruction Manual
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Electromed SmartVest Clearway Instruction Manual

Airway clearance system
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SmartVest
Clearway
Instruction Manual
®
®
Please contact Electromed at: (888) 966-2525 or
your service representative with questions about the
SmartVest Clearway
126004-S-010 Rev B
ENG
© 2022 Electromed, Inc.

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Summary of Contents for Electromed SmartVest Clearway

  • Page 1 SmartVest Clearway Instruction Manual ® ® Please contact Electromed at: (888) 966-2525 or your service representative with questions about the SmartVest Clearway 126004-S-010 Rev B © 2022 Electromed, Inc.
  • Page 3 This manual is not meant to replace your health care provider’s instructions. Neither this manual nor Electromed, Inc. provide medical advice in any capacity. Ask your doctor about any medical concerns you may have as some pre-existing conditions may become aggravated when using HFCWO therapy.
  • Page 4 If a System is replaced under the terms of this Warranty, and one or more new models of the System are available, Electromed, at its sole discretion, may replace the System with a newer or different model. In the event purchaser sends a System to Electromed which is not covered by this Warranty, as determined in Electromed’s sole...
  • Page 5 System. In addition, this Warranty is extended only to those Systems for which Electromed has been fully paid or for which the purchaser’s financial obligation has been met to the satisfaction of Electromed.
  • Page 6 In addition, this Warranty covers cost of parts and labor needed to repair the air pulse generator and power cord for covered Systems. Electromed, reserves the right to replace part or all of a System with an equivalent or repaired model. Electromed will assume responsibility for standard shipping and handling costs for the three-year warranty period.
  • Page 7 SmartVest Clearway Limited Warranty ELECTROMED’S ONLY LIABILITY, FOR DEFECTIVE SYSTEMS. ELECTROMED SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT OR OTHER LEGAL THEORY, IRRESPECTIVE OF WHETHER ELECTROMED HAS ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

  • Page 8: Table Of Contents

    Fitting the SmartVest Wrap ...............9 Fitting Accessories................10 Fitting the SmartVest Garment Extender ........10 Using a Foam Pad ................11 Cleaning the Long-Term Use (LTU) SmartVest Clearway ....11 Removing the Inner Bladder .............11 Reinserting the Inner Bladder ............12 Cleaning the Long-Term Use (LTU) SmartVest Wrap......12 Connecting Hose ................
  • Page 9 Single Patient Use (SPU) SmartVest ..........41 Single Patient Use (SPU) SmartVest Wrap........41 Single Patient Use (SPU) Connecting Hose ........41 Mobile Pedestal ................41 Airline Travel with the SmartVest Clearway ........42 Troubleshooting................43 Specifications ..................46 Electromagnetic Compatibility ............47 Prescription Record ................49...

  • Page 10: Quick Start Guide

    Quick Start Guide Therapy programs are quickly accessible and easy to start on the SmartVest Clearway device. The following steps demonstrate how to get started and begin a desired therapy. For more detailed information on how to program therapies, see pages 16-26.
  • Page 11 SmartVest Clearway Quick Start Guide Start the Therapy 1. Press on the Blue Button to start therapy. Pause the Therapy 1. Press the II button to pause therapy. Stop the Therapy 1. While therapy is paused, press the End button to stop therapy.

  • Page 13: Safety

    HFCWO treatment. Do NOT use the SmartVest Clearway near water, near any wet surface or in a highly humid environment. If the system becomes wet, allow it to dry completely before plugging it in again.

  • Page 14: Cautions

    Federal law restricts this device to sale by or on the order of a physician. Do NOT attempt to repair the system yourself. If you experience any problems, contact Electromed at (888) 966-2525 or your service representative. To report unexpected operation or events, contact Electromed at (888) 966-2525 or your service representative.

  • Page 15: Symbols

    SmartVest Clearway Symbols Symbols Attention! Read these Safety Instructions and the entire Instruction Manual before using this device. Consult instructions for use. Follow instructions for use. Pulses per second. Units are Hz. Percent of pressure. Units are %. Time. Bluetooth is connected.
  • Page 16 SmartVest Clearway Symbols Symbols Save/Restore. Screen brightness. Sleep. Good Day Therapy Label. Bad Day Therapy Label. Remove, Discard, Delete. Add a cycle to the therapy. Pause for cough. Pause a therapy. Start a paused therapy. Access the menu. Close or cancel.

  • Page 17: Equipment Classifications

    Electromed or your service representative for information on recycling the Clearway. Electromed, Inc. has been accredited by The Joint Commission to meet the requirements for the Home Care Accreditation Program. Contains FCC ID X8WBT832 for 2402 MHz to 2480 MHz.

  • Page 18: Indications For Use

    SmartVest Clearway Safety Indications for Use Electromed, Inc. has received clearance to market from the FDA for the following indications: “The Electromed, Inc. SmartVest Clearway is designed to deliver High Frequency Chest Wall Oscillation (HFCWO) to promote airway clearance and improve bronchial drainage. The SmartVest Clearway is indicated when external chest manipulation is the physician’s treatment of choice to enhance mucus transport.”...

  • Page 19: What Is High Frequency Chest Wall Oscillation (Hfcwo)

    Pediatr Pulmonol 1996; Suppl 13: A358. SmartVest Clearway The SmartVest Clearway consists of three primary components - a SmartVest garment, the Connecting Hose, and the Clearway Air Pulse Generator. In addition, there are accessories designed to aid in the use of the SmartVest Clearway that are discussed on pages 8-13.

  • Page 20: Smartvest Garments

    SmartVest Clearway SmartVest Clearway Garments SmartVest Garments The SmartVest delivers full coverage air pulses to the front, back, and sides of the torso for 360-degree oscillation. It is made of a soft, breathable fabric. The SmartVest is available in two styles – the SmartVest and the SmartVest Wrap®.

  • Page 21: Fitting The Smartvest Wrap

    SmartVest Clearway SmartVest Clearway Garments NOTE: If the front closure opens during treatment, it can be secured by opening the small strap on the left side of the SmartVest, lacing it through the D-ring, and securing it with the Velcro -like closure.

  • Page 22: Fitting Accessories

    SmartVest Clearway SmartVest Clearway Garments Fitting Accessories Using the SmartVest Extender An extender is available for those using an adult size SmartVest and requiring additional chest circumference, but not additional height. This accessory provides up to an additional 14 inches (36 cm) of chest coverage.

  • Page 23: Using A Foam Pad

    Using a Foam Pad If the patient is experiencing tenderness from a new G-tube or central catheter, Electromed can provide a foam pad to help protect the area and make the patient’s treatment more comfortable. Cleaning the Long-Term Use (LTU) SmartVest The LTU SmartVest is made up of the inner bladder and the outer shell.

  • Page 24: Reinserting The Inner Bladder

    SmartVest Clearway SmartVest Clearway Garments Reinserting the Inner Bladder NOTE: Prior to inserting the bladder, make sure the outer shell is completely dry. Steps: 1. Lay the outer shell on a flat surface. 2. Open the outer shell completely. 3. If the zipper is not already unzipped from removing the bladder, do so now.

  • Page 25: Connecting Hose

    SmartVest Clearway Connecting Hose Connecting Hose The single-hose transmits air pulses from the air pulse generator to the garment. The hose connection point is the same on both ends. Therefore, whether connecting to the generator or the garment, the insertion steps are the same.

  • Page 26: Clearway Air Pulse Generator

    To awaken the system from sleep mode, touch anywhere on the display. NOTE: SmartVest Clearway is equipped with the wireless connectivity feature. The label can be found on the bottom of the air pulse generator.

  • Page 27: Device Diagram

    SmartVest Clearway Clearway Air Pulse Generator Device Diagram Ambient Light Sensor Touch Screen User Power Indicator Light Interface Will adjust screen Will always be lit when brightness based on the device is plugged ambient light in the room Cooling Air Vents...

  • Page 28: Therapy Types

    SmartVest Clearway Clearway Air Pulse Generator Therapy Types The Clearway System has three types of therapies that can be customized to your needs and physician recommendations. Custom settings will be saved when the power is disconnected. 1. Program Mode: set and save up to 6 cycles (A-F) that can each have their own duration, frequency and pressure per cycle.
  • Page 29 SmartVest Clearway Clearway Air Pulse Generator 2. Select Program Therapy. The treatment protocol will pause or hold at the end of an interval. This is the time designated to clear secretions. The default number and duration of a pause is different by operating mode, but can be adjusted.
  • Page 30 SmartVest Clearway Clearway Air Pulse Generator 5. Adjust the cycle settings: Frequency: Press the + and - buttons to the left or right of the frequency display. Adjust in 1 Hz increments from 5 to 20 Hz. Hold the + or - button to repeatedly increment or decrement.

  • Page 31: Starting Program Therapy

    SmartVest Clearway Clearway Air Pulse Generator 8. Select Good Day or Bad Day Therapy Label if desired. Otherwise select No Label. 9. Review the Therapy Summary Page: Press the Label icon to change or add Therapy Label. Press Save to save Program Therapy.
  • Page 32 SmartVest Clearway Clearway Air Pulse Generator 3. Press the II button to pause therapy. 4. Press the button to resume therapy, or press End to end therapy. 5. When a pause is reached: The air pulses will stop. The unit will beep twice.

  • Page 33: Ramp Therapy

    SmartVest Clearway Clearway Air Pulse Generator Ramp Therapy Ramp therapy allows the patient to set a minimum (“from”) and maximum (“to”) range for the frequency and pressure delivered over a specified time duration. The system will slowly ramp frequency and pressure up and down within that range.
  • Page 34 SmartVest Clearway Clearway Air Pulse Generator 4. Continue to next screen by pressing the > button. 5. Press the + and - buttons to the left or right of the number display to increase or decrease the number of cycles. Adjust from 1 to 6 cycles.
  • Page 35 SmartVest Clearway Clearway Air Pulse Generator 8. Adjust the To settings: Frequency: Press the + and - buttons to the left or right of the frequency display. Adjust in 1 Hz increments from 5 to 20 Hz. Pressure: Press the + and - buttons to the left or right of the pressure display.

  • Page 36: Starting Ramp Therapy

    SmartVest Clearway Clearway Air Pulse Generator Starting Ramp Therapy 1. From the Home screen, press the < or > button to scroll left or right to select desired Program or Ramp therapy. Press the button to begin treatment. 2. This screen will appear: The blue bar will fill as time passes.

  • Page 37: Manual Mode

    SmartVest Clearway Clearway Air Pulse Generator 6. Wait for pause timer to run out, or press the button to resume therapy. Optional Step: Open SmartVest Connect mobile application to track therapy progress and transmit therapy session data. 7. Repeat steps 4 through 5 until all intervals or cycles of a prescribed treatment are complete.
  • Page 38 SmartVest Clearway Clearway Air Pulse Generator 2. Adjust the settings: Frequency: Press the + and - buttons to the left or right of the frequency display. Adjust in 1 Hz increments from 5 to 20 Hz. Pressure: Press the + and - buttons to the left or right of the pressure display.
  • Page 39 SmartVest Clearway Clearway Air Pulse Generator 6. Press the + and - buttons to change Frequency, Pressure, or Time. Press the button to resume therapy. Press End Therapy to end therapy. 7. If settings have been changed, press Save to save these settings as your manual mode.

  • Page 40: Menu Overview

    SmartVest Clearway Clearway Air Pulse Generator Menu Overview The menu allows activation of sleep mode, edit a therapy, favorite a therapy, store/restore a therapy, edit device settings, change the brightness of the screen, and check device hours. 1. From the home screen, press the button to access the Menu.

  • Page 41: Therapy Settings

    SmartVest Clearway Clearway Air Pulse Generator Therapy Settings To edit a Program or Ramp Therapy, follow the steps below. 1. From the Home screen, press the < or > button to scroll to select the desired therapy. 2. Press the button to access Settings.

  • Page 42: Favorite A Therapy

    SmartVest Clearway Clearway Air Pulse Generator Favorite a Therapy Favoriting a therapy will cause it to be the first one shown on the screen when the device is turned on. 1. From the Home screen, press the < or > button to scroll to select the desired therapy.

  • Page 43: Checking Device Hours

    SmartVest Clearway Clearway Air Pulse Generator Checking Device Hours 1. From the Home screen, press the button to access Settings. 2. Select Device Hours. 3. The number of hours the device has been used can be seen here, as well as a phone number for customer service.

  • Page 44: Storing A Therapy

    SmartVest Clearway Clearway Air Pulse Generator 3. Press the + and - buttons to adjust the brightness, or select Enable Auto Adjust. Auto Adjust will automatically dim or brighten the screen based on the environment’s lighting level. Note: A new device will default as Enable Auto Adjust.

  • Page 45: Restoring A Therapy

    SmartVest Clearway Clearway Air Pulse Generator 4. Press Store to Backup. Then press Yes on the following confirmation screen. Restoring a Therapy Use this setting to restore previously saved therapy settings. This is helpful if a number of changes have been made and it is necessary to start over.

  • Page 46: Sleep Mode

    SmartVest Clearway Clearway Air Pulse Generator Sleep Mode Sleep mode will dim the device screen and save power. The device will automatically go into sleep mode after a period of inactivity, or can be manually set to sleep mode. 1. From the Home screen, press the button to access Settings.

  • Page 47: Access Device Settings

    SmartVest Clearway Clearway Air Pulse Generator Access Device Settings 1. From the Home screen, press the button to access Settings. 2. Select Device Settings. 3. Access Bluetooth Settings, Device Version, Lock Device, and Diagnostics from this menu. Note: The Bluetooth Settings option is only available for Home Use devices.

  • Page 48: Enable Bluetooth

    SmartVest Clearway Clearway Air Pulse Generator Enable Bluetooth 1. Press and hold Bluetooth Settings button for 3 seconds. 2. To enable Bluetooth, select Enable Bluetooth button. 3. Select Yes button to confirm enabling Bluetooth. 4. When Bluetooth has been enabled...

  • Page 49: Locking Device

    SmartVest Clearway Clearway Air Pulse Generator Locking Device 1. Press and hold Lock Device button for 3 seconds to enable the device lock. When device is locked, patients will not be able to enter new therapies, change the frequency, pressure, or time of any existing therapies, or Store/Restore therapies.

  • Page 50: App Connection

    SmartVest Clearway Clearway Air Pulse Generator App Connection 1. Verify mobile device Bluetooth and Location settings are turned on. 2. Search for and install Smartvest Connect app in the Application Store. 3. Open Smartvest Connect app, review, and accept Terms &...
  • Page 51 SmartVest Clearway Clearway Air Pulse Generator 5. Wake up or plug in the Clearway Device. 6. Confirm Bluetooth and Location access is enabled on SmartVest Connect app. 7. Log in with SmartVest Connect account, or continue without logging in. 8. Confirm SmartVest Connected banner at the bottom of the SmartVest Connected app.

  • Page 52: Routine Care Of The Air Pulse Generator

    SmartVest Clearway Care and Wheeled Carrier Routine Care of the Air Pulse Generator Cleaning the Generator While the device is unplugged, the exterior of the generator may be cleaned with a damp cloth and a mild disinfectant on an as-needed basis.

  • Page 53: Institutional Accessories

    The following items are intended to be used only in hospitals and other institutional settings. Contact Electromed for replacement parts at (888) 996-2525. Single Patient Use (SPU) SmartVest The SPU SmartVest is intended for use by a single patient during a hospital stay.

  • Page 54: Airline Travel With The Smartvest Clearway

    It should not be stored away from the airline passenger and should NOT be checked in as baggage on ANY airline. The use of the SmartVest Clearway device while on the plane is not allowed due to Federal Aviation Administration (FAA) regulations.

  • Page 55: Troubleshooting

    Noting the reference code can help provide information that will help customer service diagnose the cause of the error message. If the suggested actions below do not resolve the issue or if the issue occurs frequently, contact Electromed or your service provider. Problem is...
  • Page 56 To replace a defective or damaged power cord, unplug from wall outlet. Unplug from generator. Plug new power cord into generator and plug into wall outlet. The air pulse Contact Electromed or your service provider for generator is making replacement. a different than normal sound.
  • Page 57 If adjusting the protocols does not resolve the discomfort, adjust the Velcro-type closures to customize shoulder fit and tightness around chest. If this does not resolve the issue, contact Electromed or your service provider for assistance with garment sizing or additional troubleshooting steps.

  • Page 58: Specifications

    SmartVest Clearway Specifications Specifications Operational • Time: 1 minute – 60 minutes ± 2% Parameters • Frequency: 5 – 20 Hz ± 2 Hz Air Pulse Generator • Weight: 13.2 lbs (6.0 kg) • Dimensions: 14 1/2” x 12 3/4” x 5 7/8” (37 x 32.5 x 15 cm)

  • Page 59: Electromagnetic Compatibility

    Electromagnetic Compatibility Guidance and Manufacturer’s Declarations - Electromagnetic Emissions The SmartVest Clearway is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.
  • Page 60 Electromagnetic Compatibility Guidance and Manufacturer’s Declarations - Electromagnetic Immunity The SmartVest Clearway is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.

  • Page 61: Prescription Record

    SmartVest Clearway Prescription Record Prescription Record SmartVest Clearway Serial # _____________________________ Prescribed Protocols User One __________ User Two __________ User Three __________ Date _______________ Date _______________ Date ________________ ______times/day ______times/day ______times/day ______minutes/treatment ______minutes/treatment ______minutes/treatment ______pressure setting ______pressure setting ______pressure setting...

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