Electromed SmartVest User manual

www.smartvest.com
Making life’s important moments possible — one breath at a time. ®
502 Sixth Avenue NW
New Prague, MN 56071
www.smartvest.com
Made in USA
Accredited by
The Joint Commission ISO 13485 / ISO 9001 Certified
SQL Instruction Manual
090491-S-010 Rev E ENG
http://waterheatertimer.org/COPD-exercises.html

© 2017 Electromed, Inc.
Please contact Electromed at: [phone] 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
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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)
[email protected]
www.smartvest.com
Foreword

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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
SmartVest SQL Airway Clearance System Table of Contents

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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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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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Safety
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.
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.
Warnings
No modification or repair of this equipment is allowed.

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Safety
Federal 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.
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 (888)
966-2525 or your service representative.
Use only compatible SmartVest SQL Airway Clearance System components
supplied by Electromed.
Do NOT staple, sew, or apply any items to the SmartVest shell that could
penetrate the inner bladder.
Do NOT apply adhesives, tapes, hot glue or hot irons to the SmartVest
shell while inner bladder is installed.
Do NOT allow any foreign materials to enter the SmartVest SQL Airway
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.
Cautions

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IP20
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).
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.
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 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.
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.

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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.
Safety

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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.
SmartVest
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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
For a proper fit, the patient should wear a
single layer of clothing underneath the
SmartVest or the SmartVest Wrap .
Fitting the SmartVest
Steps:
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.
4. Adjust the shoulder closures.
5. Attach the hose to the SmartVest
(refer to the section on Connecting Hose).
Steps 1 & 2
Step 3
Steps 4 & 5
1 Velcro®is a registered trademark of Velcro Industries B.V.

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SmartVest Garments
Fitting the SmartVest Wrap
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.
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).
Correct Fit Incorrect Fit
Steps 1 & 2
Step 3
Steps 4 & 5
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.

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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 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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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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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.