Electromed SmartVest SV2100 User manual

www.SmartVest.com
502 Sixth Avenue NW
New Prague, MN 56071
www.Electromed.com
Made in USA
Accredited by
The Joint Commission
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany ISO 13485 / ISO 9001 Certified
Instruction Manual
Model SV2100/SV2100-I
070098-S-010 Rev N ENG
http://waterheatertimer.org/COPD-exercises.html http://waterheatertimer.org/COPD-exercises.html

Service Representative:
888-966-2525
Instruction Manual
Model SV2100/SV2100-I
070098-S-010 Rev N ENG
© 2013 Electromed, Inc.

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SmartVest ® Airway Clearance System Foreward
Foreword
This Instruction Manual is designed to help you gain a thorough understanding
of the proper use of the SmartVest ® Airway Clearance System. It is strongly
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. Any medical concerns you may have should be addressed solely with
your physician.
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, Inc. 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 System itself, or any other matter, we truly
appreciate your input. If you would like to provide feedback, do not hesitate to
contact us using one of the methods shown below. We thank you in advance for
your assistance.
WARNING: NO MODIFICATION OR REPAIR OF THIS EQUIPMENT IS ALLOWED.
WITH THE EXCEPTION OF THE ROUTINE CARE AND CLEANING PROCEDURES
DESCRIBED IN THIS MANUAL, THE SMARTVEST® AIRWAY CLEARANCE
SYSTEM MUST BE RETURNED TO ELECTROMED, INC. AT THE ADDRESS
BELOW FOR ANY REPAIR OR SERVICE. DO NOT ATTEMPT TO OPEN THE AIR
PULSE GENERATOR. THIS WILL VOID THE WARRANTY.
502 Sixth Avenue NW
New Prague, MN 56071
952.758.9299 (phone)
952.758.1941 (fax)
[email protected]
www.Electromed.com
For immediate assistance, call the Patient Services Helpline at 888-966-2525.

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SmartVest ® 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 ...................................................................... 5
SmartVest ® Garments .................................................................................................... 6
Wearing the SmartVest ® or SmartVest Wrap ® .................................................... 6
Fitting the SmartVest ® ............................................................................................... 6
Fitting the SmartVest Wrap ® .................................................................................... 7
Fitting Accessories ..................................................................................................... 8
Using a Vest Extender ............................................................................................. 8
Using a Foam Pad .................................................................................................... 8
Cleaning the Long-Term Use (LTU) SmartVest ® ................................................... 8
Removing the Inner Bladder .................................................................................. 8
Reinserting the Inner Bladder ............................................................................... 9
Cleaning the Long-Term Use (LTU) SmartVest Wrap ®. ....................................... 9
Connecting Hose ............................................................................................................. 10
SV2100/SV2100-I Air Pulse Generator ......................................................................... 11
Power Cord .................................................................................................................. 11
Control Panel Overview ............................................................................................. 12
Setting Treatment Protocols ..................................................................................... 13
Setting Manual Mode ............................................................................................. 13
Setting Program Mode ........................................................................................... 14
Starting the Treatment Protocol ............................................................................... 16
Using Sleep Mode ...................................................................................................... 16
Checking Hours of Operation .................................................................................... 16
Routine Care of the Air Pulse Generator ................................................................ 17
Cleaning the Air Pulse Generator ......................................................................... 17
Replacing a Filter ..................................................................................................... 17
Replacing a Fuse ..................................................................................................... 17

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SmartVest ® Airway Clearance System Table of Contents
Wheeled Carrier and Accessory Bag .......................................................................... 18
Institutional Products ..................................................................................................... 19
Single Patient Use (SPU) SmartVest ® .................................................................... 19
Single Patient Use (SPU) SmartVest Wrap ® ......................................................... 19
SV2100-I and Mobile Pedestal .................................................................................. 19
Single Patient Use (SPU) Connecting Hose ........................................................... 19
Troubleshooting ............................................................................................................... 20
Specifications .................................................................................................................. 22
Electromagnetic Compatibility ..................................................................................... 23
Prescription Record ........................................................................................................ 26

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SmartVest ® 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 40 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 ® Airway Clearance System Safety
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® Airway Clearance System with the power
cord supplied with the device plugged into a properly grounded 3-prong
outlet.
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 a HFCWO treatment.
Do NOT use the SmartVest ® Airway Clearance System with an
extension cord.
Do NOT use the SmartVest ® 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 ® 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 ® Airway Clearance System Safety
Cautions
Federal law restricts this device to sale by or on the order of a
physician.
Do NOT operate the SmartVest ® 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 your Service Representative.
Use only compatible SmartVest ® Airway Clearance System components
supplied by Electromed, Inc.
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 ® 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.
Do NOT use a Single Patient Use (SPU) component for multiple
patients. Dispose of after it becomes soiled, the patient is discharged,
or it is no longer needed, whichever occurs first.
SPU

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SmartVest ® 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);
EN 60601-1 (2006); CAN/CSA-C22.2 No. 60601-1 (2008);
ANSI/AAMI ES60601-1 (2005); IEC 60601-1 (1988); UL60601-1
The SmartVest ® Airway Clearance System meets class 1 protection
against electrical shock.
Type BF applied parts: SmartVest ® and SmartVest Wrap ® garment
The SmartVest ® Airway Clearance System is IPXO classified - ordinary
equipment against the ingress of water.
The equipment is NOT suitable for use in the presence of flammable
anesthetic mixture with air or with oxygen or with nitrous oxide.
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 ® Airway Clearance System SmartVest ® Airway Clearance System
Indications for Use
Electromed, Inc. has received clearance to market from the FDA for the
following indications: “The Electromed, Inc. SmartVest ® 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 ® Airway Clearance System follow the
published American Association Respiratory Care (AARC) Clinical Practice
Guidelines for external manipulation of the thorax. Absolute contraindications
identified by the AARC include: (1) head and neck injury, and (2) active
hemorrhage with hemodynamic instability. Active or recent hemoptysis can be
an anticipated symptom of an underlining infection, disease or more serious
condition. Therefore, the American Association for Respiratory Care (AARC)
Guidelines for Postural Drainage Therapy advises that the decision to use this
device for Airway Clearance Therapy requires careful consideration and clinical
assessment for each patient. For further information regarding indications,
contraindications, etc., refer to AARC Clinical Practice Guideline: Postural
Drainage Therapy. These guidelines can be found at http://www.rcjournal.com/
cpgs/pdtcpg.html.
Additional information regarding the effectiveness of HFCWO treatment on
patients with various conditions and diseases can be found at www.smartvest.
com/prescription-reimbursement/clinical-indications-for-hfcwo/.
SmartVest ® Airway Clearance System
The SmartVest ® Airway Clearance System consists of three primary
components - a SmartVest ® garment, the Connecting Hose, and the SV2100/
SV2100-I Air Pulse Generator. In addition to these components, there are various
other accessories designed to aid in the use of the SmartVest ® System that are
discussed in the following sections.

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SmartVest ® Airway Clearance System SmartVest ® Garments
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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 that minimizes perspiration and itching
(refer to section on Cleaning the SmartVest ®).
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 ®, designed for ease of application, 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, make sure you 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 your waist.
3. Secure the front closure. Make sure
the SmartVest ® fits snugly around
your 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 ® Airway Clearance System SmartVest ® Garments
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Fitting the SmartVest Wrap ®
Steps:
1. Position the SmartVest Wrap ® around
your back (similar to a towel after a bath).
2. Position the arm cutouts beneath underarms.
3. Place the unprinted side of the
SmartVest Wrap ® across chest.
4. Layer the printed side of the SmartVest Wrap ®
over the unprinted 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 ® 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 of chest coverage.
Using a Foam Pad
If you are experiencing tenderness from a new G-tube or central catheter, your
Service Representative can provide you with a foam pad to help protect the
area and make your 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 attempting any vest cleaning
methods. 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 soap such
as Ivory Snow®, Dreft®, or Woolite®. 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 ® 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 ® Airway Clearance System Connecting Hose
Connecting Hose
The single-hose transmits air pulses from the air pulse generator to the
SmartVest ®. The hose connection point is the same on both ends. Therefore,
whether connecting to the generator or the SmartVest ®garment, the insertion
steps are the same.
Steps:
1. With one hand supporting either the generator or the SmartVest ® 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 ® Airway Clearance System SV2100/SV2100-I Air Pulse Generator
SV2100/SV2100-I Air Pulse Generator
The air pulse generator creates air pulses that are transmitted to the chest via
the connecting hose and vest. Its Soft Start® technology reduces “squeeze
effect” and “vest creep” on start-up.
CAUTION: Do not start the generator until the hose and SmartVest ® or
SmartVest Wrap ® 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.
Power Cord
A grounded 3-prong power cord is supplied with the device and must be
connected to a properly grounded electrical outlet. Once the power cord is
connected to the generator and outlet, the generator will automatically power
up. This automatic feature replaces the need for an on/off switch (refer to the
section on Using Sleep Mode).
NOTE: International cords are available by contacting your Service
Representative.
NOTE: Even when the power cord is removed, such as during transport, all
programmed treatment protocols are retained (refer to the section on Setting
Program Mode).

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SmartVest ® Airway Clearance System SV2100/SV2100-I Air Pulse Generator
Control Panel Overview
All treatment sessions begin from the Home screen of the SmartVest ® Air Pulse
Generator. The elements of the generator controls are described below.
• Up and Down Arrows: Press these buttons to select either Manual or
Program mode or to increase or decrease a time or frequency.
• 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 will be visible when the generator is
plugged in and receiving power.
• Air Pressure Control Dial: Adjust this dial to set the amount of “hug” felt
from the SmartVest ® during treatment.
In addition, there are a few abbreviations
used to identify the time and pulse frequency.
• MIN: Minutes
• SEC: Seconds
• Hz: Pulses per second
Up and Down
Arrows
Return to
Home
SetStart/Pause
Air Pressure
Control Dial
Power
Indicator Light