Electromed SmartVest Clearway User manual

© 2022 Electromed, Inc.
Please contact Electromed at: [phone] or
your service representative with questions about the
SmartVest Clearway
SmartVest®Clearway®Instruction Manual
126004-S-010 Rev B ENG

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SmartVest Clearway
Foreword
This manual will help you use the SmartVest® Clearway®, a high
frequency chest wall (HFCWO) therapy. It is recommended that you
read this manual in its entirety before using the system. 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.
The SmartVest System is intended for use only as prescribed by your
physician. Although simple to use, it is recommended that young or
compromised patients have a parent or caregiver present during use.
Electromed welcomes feedback on methods for improving the quality
of our products and service. Whether this feedback is regarding
information presented in this manual, the operation of the SmartVest
Clearway, or any other matter, we appreciate your input. If you would
like to provide feedback, contact Electromed or your service provider.
Electromed, Inc.
500 Sixth Avenue NW
New Prague, MN 56071
1.800.462.1045 (phone)
952.758.1941 (fax)
[email protected]
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Foreword

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ii
SmartVest Clearway
Manufacturer’s Lifetime Warranty
SmartVest® System (Homecare Placement)
Electromed, Inc. (“Electromed”) warrants its SmartVest® Airway
Clearance System (the “System”) to be free from defects in material
and workmanship during the usable lifetime of the system (the
“Warranty”). This Warranty applies only to Systems initially purchased
January 1, 2013 or later and commences on the date of the System
being shipped. This Warranty is available only to patients for whom the
unit was prescribed and who live in the United States of America (the
“Country”) at the time of purchase. If the patient moves outside the
“Country,” Electromed will warranty the System as if the patient lived
within the “Country” with the exception of shipping and handling costs.
Warranties for purchases by “non-Country resident” patients, made
in the ”Country” and then returning to their native country, will fall
under the guidelines of International Warranties and must comply with
all regulations associated with the import of medical devices into the
native country. This Warranty is not transferable.
In the event that there is a defective System covered by this Warranty,
as determined by Electromed in its sole discretion, Electromed will,
repair or replace, at its option, and at its designated repair facility, any
parts of the System found to be in need of replacement or repair. In
addition, this Warranty covers cost of parts and labor needed to repair
the air pulse generator, the power cord, SmartVest Garment, and the
flexible connecting hose for covered Systems. Electromed, reserves the
right to replace part or all of a System with an equivalent or refurbished
model.
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
discretion, Electromed will inform the customer of the cost of repairs
or replacement, if any, prior to making any repairs. In this case, the
customer will be responsible for shipping and handling costs and for
the cost of such repair or replacement.
This Warranty does not cover defects due to abuse, negligence,
misuse, mishandling, theft, unauthorized repair or modifications, normal
wear and tear, or an act of God (events outside of human control,
such as floods or other natural disasters for which no one can be held
Lifetime Warranty

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SmartVest Clearway Lifetime Warranty
responsible), or any other reason not related to defects in material or
workmanship of the 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.
THIS WARRANTY SUPERSEDES ALL OTHER SYSTEM WARRANTIES.
THIS WARRANTY IS THE PURCHASER’S SOLE REMEDY, AND
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. NO OTHER WARRANTY,
OTHER THAN THE WARRANTY CONTAINED HEREIN, IS MADE,
EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,
ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR
PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
For repair or replacement information, call the Electromed Patient
Services department at 888-966-2525.

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iv
SmartVest Clearway
Manufacturer’s U.S.A. Limited Warranty
SmartVest® System (Institutional Placements)
Electromed, Inc. (“Electromed”) warrants its SmartVest® Airway
Clearance System (the “System”) to be free from defects in material
and workmanship for a period of three (3) years. This Limited Warranty
applies only to Institutional Placement Systems initially purchased and
utilized within the United States of America. It commences on the date
of the System being shipped, applies only to the original purchaser,
and is not transferable.
In the event that there is a defective System covered by this Warranty,
as determined by Electromed in its sole discretion, Electromed will,
repair or replace, at its option, and at its designated repair facility,
any parts of the System found to be in need of replacement or repair.
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.
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
discretion, Electromed will inform the customer of the cost of repairs
or replacement, if any, prior to making any repairs. In this case, the
customer will be responsible for shipping and handling costs and for
the cost of such repair or replacement.
This Warranty does not cover defects due to abuse, negligence,
misuse, mishandling, theft, unauthorized repair or modifications, normal
wear and tear, or an act of God (events outside of human control,
such as floods or other natural disasters for which no one can be held
responsible), or any other reason not related to defects in material or
workmanship of the 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.
THIS WARRANTY SUPERSEDES ALL OTHER SYSTEM WARRANTIES.
THIS WARRANTY IS THE PURCHASER’S SOLE REMEDY, AND
Limited Warranty

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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. NO OTHER WARRANTY,
OTHER THAN THE WARRANTY CONTAINED HEREIN, IS MADE,
EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,
ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR
PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
For repair or replacement information, call the Electromed Patient
Services department at 888-966-2525.

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vi
SmartVest Clearway Table of Contents
Quick Start Guide.............................................................................viii
Safety................................................................................................1
Warnings..............................................................................................1
Cautions...............................................................................................2
Symbols ...............................................................................................3
Equipment Classifications ...................................................................5
Indications for Use...............................................................................6
Contraindications for Use....................................................................6
What is High Frequency Chest Wall Oscillation (HFCWO)?..............7
SmartVest Clearway..........................................................................7
SmartVest Garments.........................................................................8
Wearing the SmartVest or SmartVest Wrap .....................................8
Fitting the SmartVest..........................................................................8
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 .............................................................................. 13
Clearway Air Pulse Generator ..........................................................14
Powering the Generator......................................................................14
Power Cord.......................................................................................14
Using Sleep Mode ............................................................................14
Device Diagram...................................................................................15
Therapy Types.....................................................................................16
Categorize Therapy.............................................................................16
Add Therapy........................................................................................16
Program Therapy ..............................................................................16
Setting Program Therapy ..............................................................16
Starting Program Therapy .............................................................19

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SmartVest Clearway Table of Contents
Quick Start Guide.............................................................................viii
Safety................................................................................................1
Warnings..............................................................................................1
Cautions...............................................................................................2
Symbols ...............................................................................................3
Equipment Classifications ...................................................................5
Indications for Use...............................................................................6
Contraindications for Use....................................................................6
What is High Frequency Chest Wall Oscillation (HFCWO)?..............7
SmartVest Clearway..........................................................................7
SmartVest Garments.........................................................................8
Wearing the SmartVest or SmartVest Wrap .....................................8
Fitting the SmartVest..........................................................................8
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 .............................................................................. 13
Clearway Air Pulse Generator ..........................................................14
Powering the Generator......................................................................14
Power Cord.......................................................................................14
Using Sleep Mode ............................................................................14
Device Diagram...................................................................................15
Therapy Types.....................................................................................16
Categorize Therapy.............................................................................16
Add Therapy........................................................................................16
Program Therapy ..............................................................................16
Setting Program Therapy ..............................................................16
Starting Program Therapy .............................................................19
Ramp Therapy ..................................................................................21
Setting Ramp Therapy...................................................................21
Starting Ramp Therapy..................................................................24
Manual Mode....................................................................................25
Start Manual Mode and Edit Settings ..............................................25
Menu Overview ...................................................................................28
Therapy Settings...............................................................................29
Favorite a Therapy............................................................................30
Checking Device Hours ....................................................................31
Changing Screen Brightness ............................................................31
Storing a Therapy .............................................................................32
Restoring a Therapy..........................................................................33
Sleep Mode ......................................................................................34
Access Device Settings.....................................................................35
Enable Bluetooth...............................................................................36
Locking Device..................................................................................37
App Connection................................................................................38
Routine Care of the Air Pulse Generator.......................................... 40
Institutional Accessories ................................................................... 41
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

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viii
SmartVest Clearway Quick Start Guide
Put On Vest
Connect Tubing
Wake Up Device
Choose a Therapy
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.
1. Position the bottom of the
SmartVest at or slightly below the
patient’s waist.
2. Secure the front closure. Make
sure the SmartVest fits snugly
around the patient’s chest.
3. Adjust the Velcro®-like shoulder
closures.
1. With one hand supporting either
the generator or the garment
connection point, use the other
hand to insert the hose connector.
2. Give a slight twist.
1a. If unplugged, plug the power cord
into an electrical outlet.
1b. If plugged in, touch the screen to
wake up the device.
1. Scroll through prior programmed
therapies, or select from Manual
Mode.
Alternatively, press the page
icon associated with the desired
therapy.

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SmartVest Clearway
Start the Therapy
Pause the Therapy
Stop the Therapy
Cough Breaks
Quick Start Guide
1. Press on the Blue Button to start
therapy.
1. Press the II button to pause therapy.
1. While therapy is paused, press the
End button to stop therapy.
1. When a programmed pause is
reached:
The air pulses will stop.
The unit will beep twice.
2. IMPORTANT: Huff, cough, or
suction to clear secretions.
Refer to pages 11 and 12 for Cleaning Instructions.
Refer to page 38 for SmartVest Connect and set up instructions.

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SmartVest Clearway Safety
Warnings
No repair of the SmartVest system is allowed. When repair is
needed, it must be returned to Electromed. Do not attempt to
open the generator. This action will void the warranty.
Always remove the power cord before servicing the generator.
Dangerous voltage within the device may constitute a risk of
electric shock.
Always use the SmartVest Clearway with the power cord
supplied.
Do NOT eat or drink during a HFCWO treatment. If using a
chronic enteral feeding tube, discontinue feeding a half hour prior
to and a half hour after completing 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.
Cord and hose may pose a strangulation or entanglement hazard.
Do NOT route components near neck or leave at-risk individuals
unattended.
Items applied to the SmartVest Clearway may become choking
hazards to unattended at-risk individuals if removed or dislodged.
Do NOT apply items anywhere on the SmartVest shell that
would come in direct contact with patient during use.
Keep packaging materials away from babies and children. Do
NOT use in cribs, beds, carriages, or playpens. The plastic
materials may cling to nose and mouth and prevent breathing.
Packaging materials are not toys.
Use of the SmartVest adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, the SmartVest and the other
equipment should be observed to verify that they are operating
normally.
Use of accessories and cables other than those specified
or provided by Electromed could result in increased
electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.

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SmartVest Clearway
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Safety
Cautions
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the SmartVest,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
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 [phone] or your
service representative.
To report unexpected operation or events, contact Electromed at
[phone] or your service representative.
Use only compatible SmartVest components supplied by
Electromed.
Do NOT staple, sew, or apply any items to the SmartVest
garment shell that could penetrate the inner bladder.
Do NOT apply adhesives, tapes, hot glue or hot irons to the
SmartVest garment shell while inner bladder is installed.
Do NOT allow any foreign materials to enter the SmartVest
system through openings in the device, hose, or garment.
Moving air in the SmartVest garment along with multiple layers
of clothing may cause you to become warm during use. Use
system in a cooled or ventilated room and wear a single layer of
clothing underneath the SmartVest garment.
Do NOT share or allow a different patient to use your SmartVest
or SmartVest Wrap garment. Doing so may lead to cross
contamination of harmful microorganisms.
Do NOT place generator in a position that limits access to the
electrical inlet connection or blocks air inlet vents.

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SmartVest Clearway
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.
Bluetooth is not connected.
Press button to decrement. Press and hold button to
repeatedly decrement.
Press button to increment. Press and hold button to
repeatedly increment.
Press to select the previous item or the item to the left.
Press to select the next item or the item to the right.
Number of pills indicates the number of therapy pages that
can be selected. (This number can be as few as 3 and as
many as 5.) The blue/dark pill indicates the currently selected
therapy in page order. Press a gray/light pill to select the
therapy associated with that page.
Edit.
Settings.
Favorite.
Information.
Symbols

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SmartVest Clearway
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.
Symbols
Symbols

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SmartVest Clearway
Equipment Classifications
Safety
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
If potential electromagnetic conditions exist that cause interference or
affect this device, you may have to reposition the device to avoid this
condition.
Medical equipment with respect to electrical shock, fire and
mechanical hazards only in accordance with: IEC 60601-1 Edition
3.1; ANSI/AAMI ES60601-1 (2012)
The SmartVest Clearway meets class II (double insulation)
protection against electrical shock.
Type BF applied parts: SmartVest and SmartVest Wrap
garment(s).
IP21 The SmartVest Clearway is IP21 classified. Protected against
solid foreign objects of 1/2” (12.5 mm) and greater; protected
against vertically falling water drops.
The equipment is NOT suitable for use in the presence of
flammable anesthetic mixture with air or with oxygen or with
nitrous oxide.
Waste Electrical & Electronic Equipment (WEEE). Contact
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.
Wireless connectivity feature is intended for use within the 50
United States.

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SmartVest Clearway
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.”
Indications for use of the SmartVest Clearway follow the published
American Association Respiratory Care (AARC) Clinical Practice
Guidelines for Postural Drainage Therapy. For further information
regarding indications, contraindications, etc., refer to these Guidelines
at:
https://www.aarc.org/wp-content/uploads/2014/08/12.91.1418.pdf
Contraindications for Use
Absolute contraindications identified by the 1991 AARC Guidelines for
external manipulation of the thorax such as HFCWO include: (1) head and
neck injury until stabilized, and (2) active hemorrhage with hemodynamic
instability.
The AARC has also identified relative contraindications which require an
individualized clinical assessment and careful consideration by the physician
prior to prescription including: hemoptysis; subcutaneous emphysema;
recent epidural spinal infusion or spinal anesthesia; recent skin grafts on
the thorax; burns, open wounds, and skin infections of the thorax; recently
placed transvenous pacemaker or subcutaneous pacemaker; suspected
pulmonary tuberculosis; lung contusion; bronchospasm; osteomyelitis of
the ribs; osteoporosis; coagulopathy and complaint of chest-wall pain.
Additional information regarding the effectiveness of HFCWO treatment
on patients with various conditions and diseases can be found at
www.smartvest.com.
Safety

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SmartVest Clearway
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.
SmartVest System
What is High Frequency Chest Wall Oscillation (HFCWO)?
High Frequency Chest Wall Oscillation (HFCWO) has been an effective
form of airway clearance therapy for more than 20 years. HFCWO,
administered by the patented SmartVest Clearway, creates a “squeeze
and release” action around the chest and torso from 5-20 times per
second. The SmartVest inflates through a single-hose powered by a
programmable air pulse generator and delivers rapidly repeating pulses
of air that gently squeeze and release the upper body. The squeeze
and release action of the HFCWO treatment simulates repetitive “mini-
coughs,” which have been reported to effectively:
• Shear mucus away from the walls of a lung’s airways.1
• Reduce the viscosity of the secretions.2
• Propel the mucus toward the larger airways where it can be
expectorated or suctioned more easily.1, 2
1- Chang HK, Weber ME, King M. Mucus transport by high-frequency nonsymmetrical oscillatory
airflow. J Appl Physiol 1988; 65(3): 1203-1209.
2- Majaesic C, Montgomery M, Jones R, King M. Reduction in sputum viscosity using high frequency
chest compressions compared to conventional chest physiotherapy. Pediatr Pulmonol 1996; Suppl 13:
A358.

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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®.
Steps 1 & 2
Step 3
Steps 4 & 5
1. Put on the SmartVest (without securing any
of the closures).
2. Position the bottom of the SmartVest at or
slightly below the patient’s waist.
• The SmartVest has the appearance of a
vest. It is constructed of an inner bladder
with a soft, breathable fabric shell and
Velcro®-like closures.
• The SmartVest Wrap is intended for
patients finding it difficult to fit or apply the
standard SmartVest. The SmartVest Wrap
is reversible, allowing the hose to connect
to either the right or left side.
Wearing the SmartVest or SmartVest Wrap
For a proper fit, the patient should wear a single layer of clothing
underneath the SmartVest or the SmartVest Wrap.
Fitting the SmartVest
3. Secure the front closure. Make sure the
SmartVest fits snugly around the patient’s
chest.
4. Adjust the shoulder closures.
5. Attach the hose to the SmartVest (refer to
the section on Connecting Hose).