Smart Vest Manual

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502 Sixth Avenue NW
New Prague, MN 56071
www.smartvest.com
Made in USA

SQL Instruction Manual
090491-S-010 Rev E

ENG

Making life’s important moments possible — one breath at a time. ®

Accredited by
The Joint Commission

ISO 13485 / ISO 9001 Certified

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Please contact Electromed at: (888) 966-2525 or your
service representative with questions about the
SmartVest® Airway Clearance System

SQL Instruction Manual
090491-S-010 Rev E

ENG

SmartVest SQL Airway Clearance System

Foreword

Foreword
This manual will help you use the SmartVest SQL Airway Clearance System. 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 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 System 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 System, or any other matter, we
appreciate your input. If you would like to provide feedback, contact Electromed
or your service provider.

WARNING:
NO REPAIR OF THIS 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.
THE ROUTINE CARE AND CLEANING DESCRIBED IN THIS MANUAL IS
ALLOWED.
Electromed, Inc.
500 Sixth Avenue NW
New Prague, MN 56071
952.758.9299 (phone)
952.758.1941 (fax)
info@electromed.com
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SmartVest SQL Airway Clearance System

Table of Contents

What is High Frequency Chest Wall Oscillation (HFCWO)?.................................... 1
Safety ................................................................................................................................. 2
Warnings....................................................................................................................... 2
Cautions......................................................................................................................... 3
Equipment Classifications.......................................................................................... 4
Indications for Use...................................................................................................... 5
SmartVest Airway Clearance System......................................................................... 6
SmartVest Garments....................................................................................................... 7
Wearing the SmartVest or SmartVest Wrap ......................................................... 7
Fitting the SmartVest .................................................................................................. 7
Fitting the SmartVest Wrap ....................................................................................... 8
Fitting Accessories...................................................................................................... 9
Using a Vest Extender.............................................................................................. 9
Using a Foam Pad..................................................................................................... 9
Cleaning the Long-Term Use (LTU) SmartVest ...................................................... 9
Removing the Inner Bladder................................................................................... 9
Reinserting the Inner Bladder................................................................................ 10
Cleaning the Long-Term Use (LTU) SmartVest Wrap ........................................... 10
Connecting Hose.............................................................................................................. 11
SQL Air Pulse Generator................................................................................................. 12
Powering the Generator............................................................................................. 12
Power Cord................................................................................................................ 12
On/Off Switch............................................................................................................ 12
Using Sleep Mode.................................................................................................... 12
Display and Control Panel Overview........................................................................ 13
Display and Control Panel Elements..................................................................... 13
Setting Treatment Protocols...................................................................................... 14
Setting Manual Mode.............................................................................................. 15
Setting Program Mode............................................................................................ 16
Setting Ramp Mode.................................................................................................. 18
Setting a Pause......................................................................................................... 19
Starting the Treatment Protocol................................................................................ 20
Checking System Information.................................................................................... 21

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SmartVest SQL Airway Clearance System

Table of Contents

Advanced Settings....................................................................................................... 21
Setting Lock............................................................................................................... 21
Setting Save............................................................................................................... 22
Setting Restore.......................................................................................................... 22
Setting Filter............................................................................................................... 22
Routine Care................................................................................................................. 23
Cleaning the Air Pulse Generator.......................................................................... 23
Replacing a Filter...................................................................................................... 23
Replacing a Fuse...................................................................................................... 24
Wheeled Carrier............................................................................................................... 25
Airline Travel.................................................................................................................... 26
Airline Travel with the SmartVest System........................................................... 26
Airplane Mode........................................................................................................... 26
Troubleshooting................................................................................................................ 27
Specifications................................................................................................................... 29
Electromagnetic Compatibility...................................................................................... 30
Prescription Record......................................................................................................... 33

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iii

SmartVest SQL Airway Clearance System

What is HFCWO?

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 , creates a “squeeze and release” action around the
chest and torso from 5-20 times per second. The SmartVest inflates and delivers
vigorous, yet comfortable, air pulses to the body through a single-hose powered
by a programmable air pulse generator. The rapid squeeze and release action
of an 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 SQL Airway Clearance System

Safety

Warnings
Attention! Read these Safety Instructions and the entire Instruction
Manual before using this device.
Consult instructions for use.
Follow instructions for use.
Dangerous voltage within the device may constitute a risk of electric shock.
Always use the SmartVest SQL Airway Clearance System 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 SQL Airway Clearance System near water, near
any wet surface or in 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 SQL Airway Clearance System 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 patient contact 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 is not a toy.
No modification or repair of this equipment is allowed.

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SmartVest SQL Airway Clearance System

Safety

Cautions
F ederal law restricts this device to sale by or on the order of a
physician.
Do NOT operate the SmartVest SQL Airway Clearance System on any soft
surface such as a carpet or towel while in the horizontal (flat) position as
the cooling fan may be blocked.
o NOT attempt to repair the system yourself. If you experience
D
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.
se only compatible SmartVest SQL Airway Clearance System components
U
supplied by Electromed.
Do NOT staple, sew, or apply any items to the SmartVest shell that could
penetrate the inner bladder.
o NOT apply adhesives, tapes, hot glue or hot irons to the SmartVest
D
shell while inner bladder is installed.
o NOT allow any foreign materials to enter the SmartVest SQL Airway
D
Clearance 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.

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SmartVest SQL Airway Clearance System

Safety

Equipment Classifications
Medical equipment with respect to electrical shock, fire and
mechanical hazards only in accordance with: IEC 60601-1 (2005);
ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008).
The SmartVest SQL Airway Clearance System meets class II (double
insulation) protection against electrical shock.
Type BF applied parts: SmartVest and SmartVest Wrap garment(s).
IP20

The SmartVest SQL Airway Clearance System is IP20 classified.
Protected against solid foreign objects of 1/2” (12.5 mm) and greater; Not
protected against water ingress.
Do NOT spray.
he equipment is NOT suitable for use in the presence of flammable
T
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 SQL.
Contains FCC ID 2AA9B04 for 2402 MHz to 2480 MHz and FCC ID
QIPELS31-V for 779.5 MHz to 784.5 MHz and 1712.5 MHz to 1752.5 MHz.

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.

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SmartVest SQL Airway Clearance System

Safety

Indications for Use
Electromed, Inc. has received clearance to market from the FDA for the
following indications: “The Electromed, Inc. SmartVest SQL Airway Clearance
System is designed to deliver High Frequency Chest Wall Oscillation (HFCWO)
to promote airway clearance and improve bronchial drainage. The SmartVest
is indicated when external chest manipulation is the physician’s treatment of
choice to enhance mucus transport.”
Indications for use of the SmartVest SQL Airway Clearance System 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:
http://www.rcjournal.com/cpgs/pdtcpg.html

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.

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SmartVest SQL Airway Clearance System

SmartVest SQL Airway Clearance System
The SmartVest SQL Airway Clearance System consists of three primary
components - a SmartVest garment, the Connecting Hose, and the SQL Air
Pulse Generator. In addition, there are accessories designed to aid in the use of
the SmartVest System that are discussed in the following sections.

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SmartVest SQL Airway Clearance System

SmartVest Garments

SmartVest Garments
The SmartVest delivers full coverage air pulses to the front, back, and sides of the
torso. It is made of a soft, breathable fabric. The SmartVest is available in two styles –
the SmartVest and the SmartVest Wrap.
• The SmartVest has the appearance of a vest. It is constructed of an inner
bladder with a soft, breathable fabric shell and Velcro®1-type 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

Steps 1 & 2

For a proper fit, the patient should wear a
single layer of clothing underneath the
SmartVest or the SmartVest Wrap .

Fitting the SmartVest
Steps:

Step 3

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.
3. Secure the front closure. Make sure
the SmartVest fits snugly around
the patient’s chest.

Steps 4 & 5

4. Adjust the shoulder closures.
5. Attach the hose to the SmartVest
(refer to the section on Connecting Hose).

Velcro® is a registered trademark of Velcro Industries B.V.

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SmartVest SQL Airway Clearance System

SmartVest 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-type closure.

Correct Fit

Fitting the SmartVest Wrap

Incorrect Fit

Steps 1 & 2

Steps:
1. Position the SmartVest Wrap around
the patient’s back.
2. Position the arm cutouts beneath underarms.
3. Place the connector-side of the
SmartVest Wrap across chest.

Step 3

4. Layer the other side of the SmartVest Wrap
over the connector-side using the
Velcro-type closure.
NOTE: The garment should fit “snugly”
but not tightly.
5. Attach the hose to the SmartVest Wrap
(refer to the section on Connecting Hose).

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Steps 4 & 5

SmartVest SQL Airway Clearance System

SmartVest 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.
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. Special
care must be taken to ensure proper function and maintain its appearance.
• Always remove the inner bladder before cleaning the vest. The inner
bladder may be wiped off with a damp cloth.
Do not machine wash or
dry clean the inner bladder.
• The outer shell may be wiped off with a damp cloth, machine washed,
or dry cleaned. Once the bladder is removed, fully secure all Velcro-type
closures. Wash the shell by itself in a washing machine. Use the gentle
cycle with cool water (<100 degrees F, <38 degrees C) and mild detergent.
Hang dry.
Do not machine dry. Do not use the shell before it is
completely dry. The shell can also be spot cleaned with a stain stick.
Removing the Inner Bladder
Steps:
1. Lay the SmartVest on a flat surface.
2. Open the SmartVest completely.
3. Unzip the zipper.
4. Reaching inside the shell, release the five Velcro-type strips that hold the
bladder in position.
5. Remove the bladder from the shell.
CAUTION: Take care not to puncture or cut the bladder material with any
sharp objects.

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SmartVest SQL Airway Clearance System

SmartVest 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.
4. Slide the bladder up into the outer shell.
5. Tuck the four shoulder straps of the bladder into the Velcro-type
attachment points, working the ends into the corresponding pockets.
6. Attach the fifth strip near the air hose connector.
7. Check the bladder position and readjust the Velcro-type attachments
where necessary.
8. Close the zipper.

Cleaning the Long-Term Use (LTU) SmartVest Wrap
Use the following care when laundering this garment.
•

Do not machine wash. Spot clean only with a damp cloth and/or stain
stick.

• Hang dry.
•

Do not machine dry.

• Do not iron.

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SmartVest SQL Airway Clearance System

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.
Steps:
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.
NOTE: It is not necessary for all three o-rings on the connector to be fully
inserted for a proper seal.

Correct Connection

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

SQL Air Pulse Generator
The air pulse generator creates air pulses that are transmitted to the chest via
the connecting hose and garment. Its Soft Start® technology reduces “squeeze
effect” and “vest creep” on start-up.
CAUTION: Do not start the generator until the hose and SmartVest garment are
attached to the air pulse generator, as this may cause damage to the unit.
The generator is designed to operate in either the upright or horizontal position.
Anytime the generator is stopped or paused and the orientation of the device
changes, the display will automatically appear in the proper position.

Powering the Generator
There are three elements that effect the power to the generator: the power
cord, the on/off switch, and the sleep mode.
• Power Cord - Connect the supplied power cord to an electrical outlet to
power the generator. The system will not function, however, until the on/off
switch is turned to on.
• On/Off Switch - Use the power switch to turn the generator on or off.
• Sleep Mode - To conserve energy, the system enters sleep mode
automatically after 15 minutes of inactivity. The display and fan are off
during this time, but the light remains lit. To awaken the system from sleep
mode, press any button on the control panel.
NOTE: Contact Electromed or your service representative for an international
power cord.
NOTE: All treatment protocols are retained when the power cord is removed or
the power switch is shut off.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

Display and Control Panel Overview
All treatment sessions begin from the Home display of the generator. From
Home, you can select an operating mode (Manual, Program (1-3), or Ramp) or
learn about System information (Info).

Selection
Buttons
Selection
Buttons

Power
Indicator Light
Start/Pause

Set

Return to
Home

Display and Control Panel Elements:
•Selection buttons: Press these buttons to select an operating mode (manual,
program, or ramp), increase or decrease a setting, or to choose a yes/no option.
Note: The

are only visible if the button next to it can be selected.
No option
available
- inactive
buttons

• Start/Pause: Press this button to start, stop, or resume a treatment protocol.
• Set: Press this button to store the displayed values.
• Return to Home: Press this button to return to the main screen.
• Power Indicator Light: This light is visible when the generator is powered on.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

In addition, there are a few abbreviations and symbols used to identify elements
of the setting:
• MIN: Minutes
• SEC: Seconds
• Hz: Pulses per second
• %: Percent of pressure
• ~: Intervals per treatment

Setting Treatment Protocols
The SmartVest System has three operating modes: Manual, Program (1-3) and
Ramp.
• In Manual mode you set one prescribed protocol with one interval that you
can repeat or adjust each time you perform a treatment.
• In Program mode you can set and save three separate prescribed protocols
(PROGRAM 1, PROGRAM 2, and PROGRAM 3). Each program can have multiple
intervals (A-F) with a unique frequency, pressure, and time setting. This allows
multiple users to save individual prescriptions or one user to set three different
treatment protocols.
• In Ramp mode you set a start (“From”) and end (“To”) frequency and pressure
to be run for a select treatment length and divided by the number of chosen
intervals. In the example shown, the treatment length is 30 minutes. During this 30
minutes the System automatically adjusts in small increments between the From
and To and back again- 3 times. There is no need to program the frequency and
pressure manually for each interval, as you do the other operating modes.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

Setting Manual Mode
Steps:
1. From the Home screen, press

to select the Manual mode.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

2. To adjust the following settings:
• F requency - Press
or
to the left or right of the frequency display. Adjust in
1 Hz increments from 5 to 20 Hz.
•P
ressure - Press
to the left or right of the pressure display. Adjust in
increments of 5% from 10%-100%.
• T ime - Press
or
to the left or right of the time display. Adjust in 30 second
increments from :30 - 60:00 minutes.
NOTE: Frequency and pressure can be changed at any time during a Manual session.
Time can only be changed when the unit is not pulsing.

4. Press
to save the displayed values as the new default values (see Starting the
Treatment Protocol).
Setting Program Mode
Steps:
1. From the Home screen, press
select that mode.

Program-1,

Program-2, or

Program-3 to

2. From the selected Program mode (PGM-1, PGM-2, PGM-3) screen, press
select the first column of the treatment protocol.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

3. To adjust the following settings:
• Frequency - Press
or
to the left or right of the frequency display.
Adjust in 1 Hz increments from 5 to 20 Hz.
• Pressure - Press
to the left or right of the pressure display. Adjust in
increments of 5% from 10%-100%.
• Time - Press
or
to the left or right of the time display. Adjust in 30
second increments from :30 - 60:00 minutes.
NOTE: Frequency, pressure, and time cannot be changed during a Program
session.

4. Press

to save the settings for this interval and move to the next column.

Note: The currently displayed columns are underlined in the top-right corner of
the screen. Only three of the 6 (A-F) programmable columns can be shown at a
time. The blue column is being adjusted. The column to the right is next.
Displayed
columns

Currently
being
adjusted

Next
editable
column

5. Repeat this process for columns B-F or for as many intervals, as needed.
NOTE: Any columns left as 0:00 will be skipped during treatment.
6. Press
to save the displayed values as the new default values (see
Starting the Treatment Protocol).
Repeat this same process to set additional Program modes, as needed.

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SQL Air Pulse Generator

Setting Ramp Mode
Steps:
1. From the Home screen, press

2. Press

to select the Ramp mode.

to select the treatment sequence column.

3. To adjust the following settings:
• Time - Press
or
to the left or right of the time display. Adjust in 30
second increments from :30 - 60:00 minutes.
• Cycles - Press

to the left or right of the cycles display.

NOTE: Frequency, pressure, and time cannot be changed during treatment.
4. Press

to save the settings and move to the From: column.

5. To adjust the From settings:
• Frequency - Press
or
to the left or right of the frequency display.
Adjust in 1 Hz increments from 5 to 20 Hz.
• Pressure - Press
or
to the left or right of the pressure display.
Adjust in increments of 5% from 10%-100%.

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SmartVest SQL Airway Clearance System
6. Press

SQL Air Pulse Generator

to save the settings and move to the To: column.

7. To adjust the To settings:
• Frequency - Press
or
to the left or right of the frequency display.
Adjust in 1 Hz increments from 5 to 20 Hz.
• Pressure - Press
or
to the left or right of the pressure display. Adjust
in increments of 5% from 10%-100%.

8. Press
save the displayed values as the new default values (see Starting
the Treatment Protocol).
Setting a Pause
Your 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.
• Program (1-3) and Ramp - Pauses automatically for 5:00 minutes between
each of the defined intervals or cycles.
• Manual - Runs once and then holds.
To change these settings, continue on with the following steps, otherwise - skip
this section.
1. From within an operating mode, press
settings.

for 2 seconds to access the pause

2. Set the following items:
• Pauses - Press
or
to the left or right of the Pauses display to
increase or decrease the number of pauses. Adjust from 0-5 pauses or Auto.
• Time - Press
or
to the left or right of the time display. Adjust from
00:15 - 5:00 minutes or Hold.

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SQL Air Pulse Generator

SmartVest SQL Airway Clearance System

3. Press

to save these settings.

Starting the Treatment Protocol
Select the desired treatment protocol (Manual, Program 1-3, Ramp) from the Home
screen and follow the steps below.
Steps:
1. Press

to begin your treatment.

• To pause your treatment, press
displayed.
• To resume treatment, press

again. The remaining time will be
again.

2. When the treatment interval is complete,
• The timer will show 0:00.
• The air pulses will stop.
• The unit will beep twice.
3. IMPORTANT: Huff, cough, or suction to clear secretions.
4. Repeat steps 1-3 until all intervals or cycles of a prescribed treatment are
complete.
5. Press

at any time to return to the Home screen.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

Checking System Information (INFO)
From the Home screen, press

to confirm the following detail:

• Hours Run: Total number of hours used for therapy. It does not include time
when the System is paused.
• Filter Hours Left: Amount of time left before the filter needs to be replaced.
The time starts at 200 hours and subtracts the Hours Run from when the filter
was last changed (see Replacing a Filter).
• Electromed Phone Numbers: Need help? Call for assistance.
• Version Number: Electromed will ask for this when you call for support.

Advanced Settings
Setting Lock
Use this setting to lock a treatment protocol so that it can’t be accidently
overwritten. Operating modes that have been locked show a lock icon in the bottomright corner.

Steps:
1. From the Home screen, press
2. Press

next to Lock.

3. Press

to Lock the treatment protocol for all operating modes.

The default is No.
4. Press

to save the setting and return to the Set menu.

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SmartVest SQL Airway Clearance System

SQL Air Pulse Generator

Setting Save
Use this setting to perform a backup of your system that can later be restored, if
needed.
Steps:
1. From the Home screen, press
2. Press

next to Save.

3. Press

to Save the treatment protocol for all operating modes.

The default is No.
4. Press

to save the setting and return to the Set menu.

Setting Restore
Use this setting to restore a previously saved version of your system. This is helpful if
you’ve made a number of changes and need to start over. You may find its easier to
go back to protocols you know were set up properly versus manually adjusting each
setting.
Steps:
1. From the Home screen, press
2. Press

next to Restore.

3. Press

to Restore the previously saved system backup.

The default is No.
4. Press

to save the setting and return to the Set menu.

Setting Filter
The System reminds you when a filter change is due and gives you a chance to
replace the filter at that time (see Replacing a Filter). You can bypass this reminder
and the System will warn you again when it is restarted. Follow these steps if you
want to change the filter early without waiting for the “Filter Hours Left” to reach 0
(see Checking System Info).
Steps:
1. From the Home screen, press
2. Press

next to Filter.

3. Press
or
to confirm you want to reset the System “Filter Hours Left”
(see Checking System Info) to 200 hours. The default is No. At this point you
would also change the filter (see Replacing a Filter).
4. Press

to save the setting and return to the Set menu.

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SmartVest SQL Airway Clearance System

Routine Care

Routine Care of the Air Pulse Generator
Cleaning the Generator
WARNING: Always remove the power cord before servicing the generator.
The exterior of the generator may be cleaned with a damp cloth and a mild
disinfectant. Any cleaning liquids should first be sprayed on a cloth and then used.
Avoid getting liquid inside the generator.
Replacing a Filter
Routine preventive maintenance requires the air filter to be replaced every six months
or every 200 hours, whichever occurs first. A regular slot screwdriver is needed to
perform this task. Contact Electromed or your service provider for additional filters.
Steps:
1. Place the generator in the vertical orientation, remove filter access door by
loosening two slot-head screws on the top of the generator. The screws are
captured and will remain with the door.
2. Rotate and pull up on the access door.
3. Remove the air filter.

4. Install a new air filter.
5. Replace the filter access door screws.

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SmartVest SQL Airway Clearance System

Routine Care

Replacing a Fuse
Steps:
1. WARNING: First, unplug the generator.
2. Remove the fuse drawer by releasing the two side snaps with a ball-point pen
and pull drawer straight out.

3. Remove the unit’s two fuses.
4. Replace both fuses with supplied 5mm x 20mm 5 AMP, 250 VAC Fast Acting.
Contact Electromed or your service provider for additional fuses.
NOTE: Bad fuses appear identical to good fuses. Therefore, it is important to
discard the old fuses immediately to avoid confusion.

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SmartVest SQL Airway Clearance System

Wheeled Carrier

Wheeled Carrier
The one-piece wheeled carrier makes transporting your SmartVest Airway
Clearance System easier. The wheeled carrier is durable and designed to
transport all components of the SmartVest Airway Clearance System, while the
telescoping handle adjusts to your height needs.
The wheeled carrier has specific compartments for the SQL Air Pulse Generator,
SmartVest garment, connecting hose and supplement kit, which includes the air
pulse generator power cord, filters, fuse kits, and training materials.
CAUTION: The wheeled carrier is designed to carry only the weight of the
System components. Do not place additional items on the carrier.
CAUTION: Remove the generator from the carrier prior to use.

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SmartVest SQL Airway Clearance System

Airline Travel

Airline Travel with the SmartVest System
The SmartVest Airway Clearance System is a physician prescribed respiratory
therapy device considered to be a medical necessity and should be kept with
the patient at all times. 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 device while on the plane is not allowed due to
Federal Aviation Administration (FAA) regulations.
The United States Department of Transportation (DOT) has ruled that respiratory
therapy devices (i.e. the SmartVest System) brought into the cabin of an airplane
shall not count toward the limit of of carry-on items.
The United States Transportation Security Administration (TSA) rules state that
respiratory therapy devices may be inspected at any and all check-in points but
should not be separated from the prescribed owner.
However, as a precautionary measure, a statement from your physician that
describes the medical need for the SmartVest System is advised.
In addition, TSA has made a notification card available to an airline passenger
on its website that is filled out prior to arriving at the airport to inform TSA of
the patient’s medical condition. The card is presented to TSA at the time of
screening at the airport. This card is recommended by TSA to make check-in
easier but may or may not prevent further inspection.

Airplane Mode
If the SmartVest SQL is labeled with
, it is equipped with the wireless
connectivity feature. The device should be placed into Airplane Mode before
traveling. Airplane Mode is activated automatically each time the air pulse
generator is turned off and will remain active for at least 5 days or until the
generator is turned on and off again. To assure that Airplane Mode is active
during airline travel, on the day of or 1 day prior to travel, plug in the generator,
turn on the power switch and then turn off the switch.

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SmartVest SQL Airway Clearance System

Troubleshooting

Troubleshooting
In response to various environmental conditions, the generator will display
an error message. Understanding these messages will help you quickly
troubleshoot the problem. If the suggested actions below do not resolve the
issue, contact Electromed or your service provider.
Display shows…

Problem is…

Take this action…

Error 1

The motor temperature
is above the maximum
acceptable limit. The
unit will NOT start in
this state, as damage
may occur.

If the system is sitting in a
warm location, move it to a
cooler location and try again
later. If this does not resolve
the issue, contact Electromed
or your service provider.

Error 2

The motor temperature
is below 50 degrees
Fahrenheit (10 degrees
Celsius) and needs to
warm up.

Leave the unit plugged in
and turned on so the fan
can assist in warming up the
unit. With the unit power on,
the device will periodically
check the motor temperature
and after warming up, it will
automatically proceed to the
Home screen.
If this does not resolve the
issue, contact Electromed or
your service provider.

Error 3

Motor rotation has not
been detected.

Contact Electromed or your
service provider.

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SmartVest SQL Airway Clearance System

Troubleshooting

Problem is…

Take this action…

There is no power to
the air pulse generator,
or the vest does not
pulse.

Confirm whether the device is in Sleep mode.
Is the Power Indicator Light illuminated?
• If Yes, press any button to awaken the device (refer
to the section on Using Sleep Mode).
• If No, confirm or take action in the following order.
 T he power cord is firmly connected to the
generator.
 T he power cord is firmly connected to the wall
outlet.
 The wall outlet has power.
R
eplace the fuses (see Replacing a Fuse).

The garment does not
fully inflate.

Confirm or take action in the following order.
 T he hose is firmly attached to the couplings
and the generator.
 T he connecting hose is free of leaks.
 T he inner bladder is free of tears.
 T he inner bladder is attached smoothly inside
the outer shell. The Velcro-type closures are
lying flat and are free from buckling.

R
eplace the air input filter (see Replacing a
Filter).

It is difficult to breathe
during treatment.

The garment will slightly compress the chest during
treatment. Reduce pressure within your protocol
until the patient is comfortable with the sensation.
Soon the patient will become used to the feeling and
will be able to increase the pressure. You may also
need to reduce the pressure when you are ill.

The data on the display
does not appear to be in
the correct position.

In rare cases static discharge may cause the display
to become irregular. To reset the display press
.

The vest no longer fits.

Contact Electromed or your service provider for a
replacement.

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SmartVest SQL Airway Clearance System

Specifications

Specifications
Operational Parameters

• Time: 30 seconds – 30 minutes ± 2%
• Frequency: 5 – 20 Hz ± 2 Hz

Air Pulse Generator

• Weight: 17 lbs (7.7 kg)
• Dimensions: 14 5/8” x 14” x 6 1/4” (37 x 35.5 x 16 cm)

Vest(s)

Available in eight sizes for long-term and single
patient use.

Wrap(s)

Available in six sizes for long-term and single
patient use.

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.

Electrical

• 100 – 240 V~, 50/60 Hz
• 3.3 Amps at 100 V~
• 1.6 Amps at 240 V~
• Fuses: Two (2) 5mm x 20mm 5 Amp 250VAC
Fast-Acting, 1500 Amp Breaking Capacity

Operation Conditions

• 40ºF – 84ºF (5°C – 29°C)
• 15% – 93% relative humidity, non-condensing
• 70 kPa to 106 kPa

Transport and Storage
Conditions

• -13°F – 158°F (-25°C – 70°C)
• 0% – 93% relative humidity, non-condensing
• 50 kPa to 106 kPa

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SmartVest SQL Airway Clearance System

Electromagnetic Compatibility

Electromagnetic Compatibility
Guidance and Manufacturer’s Declarations – Electromagnetic Immunity
The SmartVest SQL Airway Clearance System 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.
Immunity test

IEC 60601 test
level

Compliance level Electromagnetic
environment – guidance

Electrostatic
± 6 kV contact
discharge (ESD) IEC
± 8 kV air
61000-4-2

± 6 kV contact

Electrical fast
transient/burst IEC
61000-4-4

± 2 kV for power
supply lines

± 2 kV for power
supply lines
± 1 kV for input/
output lines

± 8 kV air

Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.

Mains power quality
should be that of a typical
commercial or hospital
N/A for input/output
environment.
lines
± 1 kV line(s) to
line(s)

Mains power quality
should be that of a typical
commercial or hospital
± 2 kV line(s) to earth ± 2 kV line(s) to earth environment.

Surge IEC 61000-4-5 ± 1 kV line(s) to
line(s)

Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11

<5 % UT (>95 % dip in <5 % UT (>95 % dip in Mains power quality
UT) for 0,5 cycle
should be that of a typical
UT) for 0,5 cycle
commercial or hospital
40 % UT (60 % dip in 40 % UT (60 % dip in environment. If the user
UT) for 5 cycles
UT) for 5 cycles
of the System requires
70 % UT (30 % dip in 70 % UT (30 % dip in continued operation during
power mains interruptions,
UT) for 25 cycles
UT) for 25 cycles
it is recommended that the
<5 % UT (>95 % dip in <5 % UT (>95 % dip in System be powered from an
UT) for 5 s
UT) for 5 s
uninterruptible power supply
or a battery.

Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8

3 A/m

Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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SmartVest SQL Airway Clearance System

Electromagnetic Compatibility

Guidance and Manufacturer’s Declarations – Electromagnetic Immunity
The SmartVest ® SQL Airway Clearance System 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.
Immunity
test

IEC 60601
test level

Compliance
level

Electromagnetic environment –
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the System, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz

Radiated RF
IEC 61000-4-3

d = 1,17 √P
d = 1,17 √P 80 MHz to 800 MHz

3 V/m

d = 2,33 √P 800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the System is used
exceeds the applicable RF compliance level above, the System should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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SmartVest SQL Airway Clearance System

Electromagnetic Compatibility

Recommended separation distances between portable
and mobile RF communications equipment and the
SmartVest SQL Airway Clearance System.
The SmartVest Airway Clearance System is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the System can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the System as recommended
below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter
W

m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1,17 √P
d = 1,17 √P
d = 2,33 √P

0,01

0,12

0,23

0,1

0,37

0,74

1,17

2,33

3,70

7,37

100

11,70

23,30

For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects,
and people.

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SmartVest SQL Airway Clearance System

Prescription Record

SmartVest SQL Airway Clearance System
Serial # _____________________________
Prescribed Protocols
User One ____________ User Two ____________ User Three ____________
Date ________________ Date ________________ Date _________________
______times/day

______times/day

______minutes/treatment ______minutes/treatment

______minutes/treatment

______pressure setting

Frequency Duration

Frequency

Frequency Duration

Duration

_________ _________ _________ _________

_________ _________

_________ _________ _________ _________

_________ _________

_________ _________ _________ _________

_________ _________

_________ _________ _________ _________

_________ _________

_________ _________ _________ _________

_________ _________

_________ _________ _________ _________

_________ _________

Aerosols ____________

NOTE: Do not change your protocol without first consulting your health care
provider.

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502 Sixth Avenue NW
New Prague, MN 56071
www.smartvest.com
Made in USA

SQL Instruction Manual
090491-S-010 Rev E

ENG

Making life’s important moments possible — one breath at a time. ®

Accredited by
The Joint Commission

ISO 13485 / ISO 9001 Certified

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