Smart Vest SV2100 Ins.. Instruction Manual

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Model SV2100/SV2100-I

Accredited by
The Joint Commission

Instruction Manual
070098-S-010 Rev N

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

ENG

502 Sixth Avenue NW
New Prague, MN 56071
www.Electromed.com
Made in USA
ISO 13485 / ISO 9001 Certified

www.SmartVest.com

Service Representative:
888-966-2525

Model SV2100/SV2100-I

Instruction Manual
070098-S-010 Rev N

ENG

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)
info@electromed.com
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.
angerous voltage within the device may constitute a risk of electric
D
shock.
lways use the SmartVest® Airway Clearance System with the power
A
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.
o NOT use the SmartVest ® Airway Clearance System with an
D
extension cord.
o NOT use the SmartVest ® Airway Clearance System near water,
D
near any wet surface or in highly humid environment. If the system
becomes wet, allow it to dry completely before plugging it in again.
ord and hose may pose a strangulation or entanglement hazard. Do
C
NOT route components near neck or leave at-risk individuals unattended.
I tems applied to the SmartVest ® Airway Clearance System may
become choking hazards to unattended at-risk individuals if removed or
dislodged.
o NOT apply items anywhere on the SmartVest ® shell that would
D
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
F ederal 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.
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 ® 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.
SPU

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.

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SmartVest ® Airway Clearance System

Safety

Equipment Classifications
edical equipment with respect to electrical shock, fire and
M
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
T he SmartVest ® Airway Clearance System is IPXO classified - ordinary
equipment against the ingress of water.
T he 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

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

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 ®

Steps 1 & 2

For a proper fit, make sure you wear a
single layer of clothing underneath the
SmartVest ® or the SmartVest Wrap ® .

Fitting the SmartVest ®

Step 3

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).
1

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

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Steps 4 & 5

SmartVest ® 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
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.

Step 3

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).

Steps 4 & 5

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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
Do not
methods. The inner bladder may be wiped off with a damp cloth.
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
Do not machine dry.
as Ivory Snow®, Dreft®, or Woolite®. Hang 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

Start/Pause

Set

Air Pressure
Control Dial

Return to
Home

Power
Indicator Light

• 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

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SmartVest ® Airway Clearance System

SV2100/SV2100-I Air Pulse Generator

Setting Treatment Protocols
The SmartVest ® System has two operating modes, Manual and Program.
• In Manual mode you set the prescribed protocol 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). This allows multiple users to save
individual prescriptions or one user to set three different treatment protocols.
Setting Manual Mode
Steps:
1. From the Home screen, press

next to the word MANUAL.

2. Set the following items.
• Set the Time by pressing
and
buttons to the left of the screen.
NOTE: The time setting can only be changed when unit is not pulsing.
• Set the Frequency by pressing
and
buttons to the right of the screen.
NOTE: Frequency settings can be changed at any time in Manual mode.
This allows the patient to vary the frequency during a treatment session.

Press
to store the displayed values as the new default values (refer to the
section on Starting the Treatment Protocol).
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SmartVest ® Airway Clearance System

SV2100/SV2100-I Air Pulse Generator

Setting Program Mode
Steps:
1. From the Home screen, press either
PROGRAM 2, or PROGRAM 3.

next to PROGRAM 1,

2. From the selected PROGRAM mode screen, press
interval of the treatment protocol.

3. With line A highlighted, use
the required Time.

to select the first

to the left of the display screen to set

NOTE: Time is adjustable in 30 second increments up to 30 minutes.

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SmartVest ® Airway Clearance System

SV2100/SV2100-I Air Pulse Generator

4. Continuing with line A highlighted, use
screen to set the required Frequency.

to the right of the display

NOTE: Frequency is adjustable in 1 Hz increments from 5 to 20 Hz.

5. Press

to save the setting and advance to the next line.

6. Repeat this process for lines B-F or for as many intervals as are required (up
to a maximum of 6) by your prescribed treatment protocol.
NOTE: Any line left as 0:00 will be skipped during treatment.
This same procedure can now be repeated to set additional PROGRAM modes
(PROGRAM 1, PROGRAM 2, or PROGRAM 3).

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SmartVest ® Airway Clearance System

SV2100/SV2100-I Air Pulse Generator

Starting the Treatment Protocol
Select the desired treatment protocol from the Home screen and follow the steps below.
Steps:
1. Press

to begin your treatment interval.

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

again. The remaining time will be displayed.
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 of prescribed treatment are complete.
5. Press

at any time to return to the Home screen.

Using Sleep Mode
In order to conserve energy, the SmartVest ® Airway Clearance System will
automatically enter sleep mode after 15 minutes of inactivity. While in sleep
mode the display and fan will be off, but the power indicator light will remain lit.
To manually place the system into sleep mode,
• From the Home screen, press and hold both
and
The buttons on either side of the display may be used.

at the same time.

To awaken the system from sleep mode,
• Press any button on the control panel.

Checking Hours of Operation
Press and hold
while at the Home screen to check the total number of hours
the SmartVest ® Airway Clearance System has been used.

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SmartVest ® Airway Clearance System

SV2100/SV2100-I Air Pulse Generator

Routine Care of the Air Pulse Generator
Cleaning the Air Pulse Generator
WARNING: Always remove the power cord before cleaning or servicing the air
pulse generator.
The exterior of the air pulse generator and connecting hose may be cleaned
with a damp cloth and a mild household disinfectant. Any cleaning liquids should
first be sprayed on a cloth and then used. Avoid getting water or cleaning liquid
inside the air pulse generator.
Replacing a Filter
Routine preventive maintenance requires the air input filter to be replaced every six
months or every 200 hours, whichever occurs first. No tools are required to perform
this task. If you need additional filters, contact your Service Representative.
Steps:
1. Remove the filter access door on the bottom of the generator. To do this,
a. Press the release tab.
b. Pull up on the access door.
2. Remove and discard the old filter.
NOTE: The old filter may not look much different
than the new filter. Therefore, it is important to
discard the filter immediately to avoid confusion.
3. Install the new filter. Do not operate the
device without a filter in place.
4. Replace the access door.
Replacing a Fuse
Steps:
1. WARNING: First unplug the power cord from
the generator.
2. Remove the fuse holder located at the power inlet.
3. Remove both fuses.
NOTE: Bad fuses appear identical to good fuses.
Therefore, it is important to discard the old fuses
immediately to avoid confusion.
4. Replace the original fuses provided with the
generator with the new fuses.

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SmartVest ® Airway Clearance System

Wheeled Carrier and Accessory Bag

Wheeled Carrier and Accessory Bag
The wheeled carrier and accessory bag make transporting your SmartVest ®
Airway Clearance System easier. The wheeled carrier case is durable and the
generator easily slides in and out, while the telescoping handle adjusts to your
height needs.
The customized accessory bag has specific compartments for your SmartVest ® ,
hose, power cord, filter and fuse kits, and training materials. The back of
the accessory bag has a convenient slot where the handle of the carrier fits
through. This feature allows the accessory bag to sit snugly on top of the
generator bag and against the telescoping handle as you wheel the carrier,
resulting in a single wheeled component.
CAUTION: The wheeled carrier is designed to carry only the weight of the
SmartVest ® Airway Clearance System components. Do not place additional
equipment or luggage on the carrier.
CAUTION: Remove the generator from the carrier prior to use.

Accessory Bag

Wheeled Carrier

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SmartVest ® Airway Clearance System

Institutional Products

Institutional Products
The following items are intended to be used only in hospitals and other
institutional settings.

Single Patient Use (SPU) SmartVest ®
The SPU SmartVest ® is intended for use by a single patient during a hospital or
clinic stay. The SPU SmartVest ® should not be used for multiple patients. It is
not designed to be cleaned and should be disposed of after it becomes soiled,
the patient is discharged, or it is no longer needed, whichever comes first.

Single Patient Use (SPU) SmartVest Wrap ®
The SPU SmartVest Wrap ® is intended for use by a single patient during a
hospital stay. It is not designed to be cleaned and should be disposed of after it
becomes soiled, the patient is discharged, or it is no longer needed, whichever
comes first.

SV2100-I and Mobile Pedestal
The SmartVest ® Model SV2100-I Air Pulse Generator is available for institutions
requiring easy mobility of the SmartVest ® Airway Clearance System. This model
is specifically designed to mount to a Mobile Pedestal, which features
• Rugged attachment of the air pulse generator.
• Stable 5 caster-base with 2 locking casters.
• Foot-operated lever for height adjustment.
To properly utilize the Mobile Pedestal,
• Press down on foot release ring to raise
pedestal height.
• Press down on foot release ring and side
handles simultaneously to lower pedestal height.
• Adjust height to the “down” position while
transporting between rooms.
• Set brakes by twisting axle levers on casters.

Single Patient Use (SPU) Connecting Hose
The SPU Connecting Hose is intended for use by a single patient during a
hospital stay. As a complement to the Single Patient Use garments, it is intended
to be replaced as needed or disposed of after the patient is discharged.
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SmartVest ® Airway Clearance System

Troubleshooting

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

Problem is…

Error 1
The motor temperature

is above the maximum

acceptable limit. The

unit will NOT start in

this state, as damage

may occur.

Error 2
The motor temperature

is below 50 degrees

Fahrenheit (10 degrees

Celsius) and needs

to warm up.

Error 3

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Motor rotation has not
been detected.

Take this action…
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 your Service
Representative.
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 your Service
Representative.
Contact your Service
Representative.

SmartVest ® Airway Clearance System

Troubleshooting

At times you may experience additional issues. If the suggested actions below
do not resolve the issue, contact your Service Representative.
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.
 The power cord is firmly connected to the
generator.
 The power cord is firmly connected to the wall
outlet.
 The wall outlet has power.
 Replace the fuses (refer to the section on
Replacing a Fuse).

The garment does not
fully inflate.

Confirm or take action in the following order.
 The hose is firmly attached to the couplings
and the air pulse generator.
 The connecting hose is free of leaks.
 SmartVest ® inner bladder is free of tears.
 The inner bladder of the SmartVest ® is
attached smoothly inside the outer shell. The
Velcro-type closures are lying flat and are free
from buckling.

Replace the air input filter (refer to the section
on Replacing a Filter).

It is difficult to breathe
during treatment.

The garment will slightly compress the chest during
treatment. Reduce pressure with the Pressure dial
until you are comfortable with the sensation. Soon
you 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 your Service Representative for a replacement.

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SmartVest ® Airway Clearance System

Specifications

Specifications
Operational Parameters

• Time: 0 – 30 minutes ± 2%
• Frequency: 5 – 20 Hz ± 1 Hz

Air Pulse Generator

• Weight: 23 lbs (10.5 kg)
• Dimensions: 15 3/4” x 15” x 7 1/4” (40 x 38 x 18.5 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.

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

• 50ºF – 84ºF (10°C – 29°C)
• 15% – 93% relative humidity, non-condensing
• 70 kPa to 106 kPa

Transport and Storage
Conditions

• -4°F – 140°F (-20°C – 60°C)
• 5% – 95% relative humidity, non-condensing
• 50 kPa to 106 kPa

22 www.smartvest.com

SmartVest ® Airway Clearance System

Electromagnetic Compatibility

Electromagnetic Compatibility
Guidance and Manufacturer’s Declarations – Electromagnetic Immunity
The SmartVest ® Airway Clearance System Model SV2100/SV2100-I is intended for use in
the electromagnetic environment specified below. The customer or the user of the Model
SV2100/SV2100-I 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 UT) for 0,5 cycle

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

3 A/m

Mains power quality
should be that of a typical
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 Model SV2100/
70 % UT (30 % dip in 70 % UT (30 % dip in SV2100-I requires continued
operation during power
UT) for 25 cycles
UT) for 25 cycles
mains interruptions, it is
<5 % UT (>95 % dip <5 % UT (>95 % dip recommended that the Model
in UT) for 5 s
in UT) for 5 s
SV2100/SV2100-I be powered
from an uninterruptible power
supply or a battery.
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 ® Airway Clearance System

Electromagnetic Compatibility

Guidance and Manufacturer’s Declarations – Electromagnetic Immunity
The SmartVest ® Airway Clearance System Model SV2100/SV2100-I is intended for use
in the electromagnetic environment specified below. The customer or the user of the
Model SV2100/SV2100-I should assure that it is used in such an environment.
Immunity
test

IEC 60601
test level

Compliance Electromagnetic environment –
level
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Model SV2100/SV2100-I, 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 metres
(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: T hese 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 Model SV2100/
SV2100-I is used exceeds the applicable RF compliance level above, the Model SV2100/
SV2100-I should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
Model SV2100/SV2100-I.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

24 www.smartvest.com

SmartVest ® Airway Clearance System

Electromagnetic Compatibility

Recommended separation distances between portable
and mobile RF communications equipment and the
SmartVest ® Airway Clearance System, Model SV2100/SV2100-I
The SmartVest ® Airway Clearance System Model SV2100/SV2100-I is intended
for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Model SV2100/SV2100-I can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Model SV2100/SV2100-I 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 ® Airway Clearance System

Prescription Record

Prescription Record
SmartVest ® Airway Clearance System Model SV2100/SV2100-I
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.

26 www.smartvest.com

Model SV2100/SV2100-I

Accredited by
The Joint Commission

Instruction Manual
070098-S-010 Rev N

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

ENG

502 Sixth Avenue NW
New Prague, MN 56071
www.Electromed.com
Made in USA
ISO 13485 / ISO 9001 Certified

www.SmartVest.com

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Smart Vest SV2100 Ins.. Instruction Manual

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