Tactile Medical AFFLOVEST User manual

AoVest®Instructions for Use
and User Manual
Frees patients. Mobilizes secretions. Advances therapy.

2
Table of Contents
Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . 3
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Indications for Use/Method/Application . . . . . . . . . . . . 6
Unpacking and Using the AoVest for the First Time . . . .6
Fitting the AoVest . . . . . . . . . . . . . . . . . . . . . . . . .8
Controller Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Running a Treatment Cycle . . . . . . . . . . . . . . . . . . . . . 9
Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Menu Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Program Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Usage Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Turning o the AoVest . . . . . . . . . . . . . . . . . . . . .12
Transportation, Operation and Storage Conditions. . . . . 12
Cleaning the AoVest . . . . . . . . . . . . . . . . . . . . . . . 13
Preventative Inspection, Calibration and Maintenance . . 13
Cleaning and Care Warnings . . . . . . . . . . . . . . . . . . . 14
Battery Warning Information . . . . . . . . . . . . . . . . . . . 14
Safety Information: General . . . . . . . . . . . . . . . . . . . 15
Safety Information: Power Supply and Battery . . . . . . .15
Environmental Protection . . . . . . . . . . . . . . . . . . . .16
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Resetting the AoVest . . . . . . . . . . . . . . . . . . . . . .18
Electromagnetic Guidelines for Clinical Applications. . . . 19
AoVest Limited Warranty . . . . . . . . . . . . . . . . . . . . 22
Manufactured by Tactile Medical
3701 Wayzata Blvd, Suite 300, Minneapolis, MN 55416 USA
Toll Free Tel: [phone]
Toll Free Fax: [phone]
aovest.com
Welcome to AoVest
Dear Customer,
Congratulations on your purchase of an AoVest from
Tactile Medical! We are excited to help you manage your
health with this innovative at-home therapy that has been
used by 10,000s of people just like you. To ensure that you
derive maximum benet from the AoVest and to ensure
your safety, please familiarize yourself with the information
in this AoVest User Manual.
The AoVest User Manual contains important SAFETY and
TECHNICAL DATA. Please keep this manual in a safe place
for easy reference.
With proper care, the AoVest will reward you with a
long, trouble-free service life. We greatly value the
satisfaction of our customers and hope you are completely
satised with your AoVest by Tactile Medical. For
assistance setting up or using the AoVest, or to report
an unexpected issue please contact Tactile Medical, or
the local durable medical equipment provider (DME) that
supplied you with the AoVest.

3Customer Service Toll-Free: 800.575.1900
Explanation of Symbols
SYMBOL EXPLANATION SYMBOL EXPLANATION SYMBOL EXPLANATION
Caution Standby Refer to Instructions for Use
Type BF Equipment -
All parts considered applied
parts
Play/Pause Keep dry
Direct Current High Intensity Do not tumble dry
Manufacturer Medium Intensity Do not iron
Reference Number Low Intensity Do not wet clean
Lot Number Do not machine wash Do not bleach
Serial Number
Waste electrical and electronic
equipment; do not dispose in
household waste. Dispose of
equipment in accordance with
all relevant local, state and
federal regulations.
Protected against ingress of solid
foreign objects ≥0.04” (1.0 mm)
in diameter and dripping water
(at 15° tilt).

4
Technical Data
Nominal voltage: 14.8VDC
Nominal power consumption: Approx. 30W
Power supply: Battery operated AC/DC power. Please see directions for use that come with power
supply. The provided power supply is specied as part of the AoVest system.
Lithium-ion battery: MODEL: 8052
OUTPUT: 14.8VDC, 5.2Ah typ, 77Wh, Li-ion
CHARGING VOLTAGE: 18VDC, 2.75A min
Manufacturer: Tactile Medical
3701 Wayzata Blvd, Suite 300
Minneapolis, MN 55416 USA
Toll Free Tel: [phone]
Toll Free Fax: [phone]
Sizes: Seven sizes available:
XXS (Extra Extra Small)
XS (Extra Small)
S (Small)
M (Medium)
L (Large)
XL (Extra Large)
XXL (Extra Extra Large)
Treatment times: Vary depending on physician prescription
Modes of operation: Eight oscillation motors, eight pressure waveforms

5Customer Service Toll-Free: 800.575.1900
Safety Features
The AoVest was designed with maximum safety in mind,
therefore it contains the following safety features:
Motors operate at safe, low voltages.
Controller contains a fuse in the event of electrical
problems.
The controller operates on a timer to ensure shut-o.
User Information
IMPORTANT
The AoVest should be worn over clothing or with a fabric
shield to prevent cross-contamination in a clinic or hospital
setting where more than one patient uses the unit. The
AoVest should be cleaned appropriately between patient
use, see the Cleaning the AoVest section.
According to the American Association for Respiratory
Care (AARC) Guidelines for Postural Drainage Therapy, the
decision to use the unit for airway clearance therapy (ACT)
requires careful consideration and a doctor’s assessment of
the individual patient’s case if the following conditions exist:
Intracranial pressure (ICP) greater than 20 mm Hg
Recent spinal surgery or acute spinal injury
Bronchopleural stula
Pulmonary edema associated with congestive
heart failure
Large pleural eusions or empyema
Pulmonary embolism
Acute illness
Pregnancy or nursing mothers
Electronic implants
Rib fractures, with or without ail chest
Surgical wound or healing tissue or recent skin grafts or
aps on the thorax
Uncontrolled hypertension
Distended abdomen
Recent esophageal surgery
Active or recent gross hemoptysis
Uncontrolled airway at risk for aspiration such as tube
feeding or a recent meal
Subcutaneous emphysema
Recent epidural spinal infusion or spinal anesthesia
Burns, open wounds and skin infections on the thorax
Recent placement of transvenous or subcutaneous
pacemaker
Suspected pulmonary tuberculosis
Lung contusion
Bronchospasm
Osteoporosis or osteomyelitis of the ribs
Coagulopathy
Complaint of chest wall pain

6
Indications for Use/Method/
Application
Indications for Use
The AoVest is intended for promoting airway clearance
and improvement of bronchial drainage by enhancing
mobilization of bronchial secretions where external
manipulation of the thorax is the physician’s choice
of treatment.
Method
The AoVest generates vibration and oscillation of the
user’s chest wall through integrated motor modules,
installed into various parts of the vest. The patient controls
the rate and frequency at which these motors oscillate the
thoracic region with the use of a controller attached to
the vest that can increase or decrease intensity to address
the volume of mucus present in the air pathways, in
compliance with a physician’s prescription and orders.
Application
The AoVest may be prescribed for one of these
conditions*:
Bronchiectasis
Cystic brosis
Late eects of poliomyelitis
Other deciencies of circulating enzymes
Anterior horn cell diseases
Multiple sclerosis
Quadriplegia
Muscular dystrophy
Myotonic disorders
Myopathies
Disorders of the diaphragm
* Not all conditions allow for insurance reimbursement;
contact your provider for details.
Unpacking and Using the AoVest
for the First Time
IMPORTANT
Please follow the steps in order to ensure proper set-up.
Battery must be fully charged before use (this is covered in
the steps below).
Step 1: Unpacking the AoVest
Carefully unpack the AoVest and its accessories.
Package contents:
AoVest Rechargeable Battery
(Li-ion)
Power Supply Carrying Case
User Manual

7Customer Service Toll-Free: 800.575.1900
Step 2: Checking Battery Level and
Charging Battery
IMPORTANT
Use only the supplied rechargeable battery and the
supplied power supply to ensure safe and reliable
operation of the AoVest.
To check the battery level, depress the fuel gauge push-
button to activate the fuel gauge LEDs.
Battery level push button
The battery LEDs will light up to indicate the battery level:
1 LED
blinking
2 LEDs
lit
3 LEDs
lit
4 LEDs
lit
5 LEDs
lit
0 –19% 20–39% 40–59% 60–79% 80–100%
To charge the battery, connect the power supply to a wall
outlet and plug the power supply into the battery port as
shown. The power supply LED will turn on when connected
to the wall outlet.
Power Supply LED lit
Next, plug the power supply plug into the AoVest
battery. There is a small opening at the bottom of the
battery pouch.
Power supply connected to battery
IMPORTANT
When the power supply is plugged into the battery, pay
close attention not to place any strain onto the power
supply cord. Rough handling of the vest and power
supply while plugged into the battery could cause
damage to the battery.
When the battery is charging, the LEDs will become
lit with one (1) LED blinking. Note, this may take 5–10
seconds for the LEDs to light after plugging in the
power supply.
It is recommended to allow the battery to fully charge for
at least three (3) hours and until all LEDs are solidly lit.
At the completion of charging, disconnect the power
supply from the battery. It is recommended that the
power supply be unplugged from the wall outlet and
stored until next use.
The battery gauge LEDs will remain lit for approximately
one (1) minute after removing the power supply.

8
Fitting the AoVest
Unbuckle the chest buckles on the AoVest and
set the buckles to maximum size.
Put on the AoVest and fasten all 3 buckles. Firmly
pull the buckle straps so that the vest ts snugly on
the body, but does not restrict a deep, full breath.
After adjusting, the sides of the AoVest should have
less than a 5 inch (12.7 cm) gap. They may overlap up
to 1 inch (2.5 cm).
Adjust the shoulder snaps to place the front upper
AoVest motors on the upper chest just below the
collar bone.
Step 3: Disconnecting and Reconnecting
the Battery
The AoVest battery comes connected inside of the
battery pouch. The battery should not require
disconnection or removal from the AoVest during
normal use. The serial number tag is included inside the
battery pouch.
Battery connected
To disconnect the battery from the AoVest, simply
unplug the battery plug from the vest.
Battery disconnected
The battery can now be removed from the AoVest.
When re-connecting the AoVest battery, the controller
should beep briey when the battery is connected.
Keep the AoVest battery pouch closed to protect the
battery and wires from potential damage.
Your AoVest is now ready for use!
IMPORTANT
Unplug the power supply from outlet when not in use.
If the battery has not been used for more than 30 days,
please recharge prior to using.

9Customer Service Toll-Free: 800.575.1900
Controller Layout
(Standby)
Press and hold
to turn controller
On and O
GO
Press to start
pre-programmed
GO sequences
P
V
D
Percussion,
Vibration,
Drainage modes
High intensity
Medium intensity
Low intensity
(Play/Pause)
Press to start
treatment from
Main Menu. Press
to select Program/
Usage Menus
(Up/Down)
Press to navigate
through menu
items
(Left/Right)
Press to
change current
highlighted
selection
Running a Treatment Cycle
When the AoVest is properly setup, press and hold
the (Standby) button on the controller. After a brief
start-up period (Figure 1), the controller will navigate to the
Main Menu (Figure 2).
Figure 1. Welcome Screen Figure 2. Main Menu
Treatment may be started at any time by hitting the
(Play/Pause) button from the Main Menu. Pressing the
following buttons will update the treatment whether the
vest is running or not:
P: Percussion mode, all motors operate in a pulsed fashion.
V: Vibration mode, all motors operate continuously.
D: Drainage mode, motors operate in a pre-programmed
sequential fashion.
GO: Automatically starts the GO mode, the system
will perform the following treatments sequentially
(by default):
– Percussion mode, 10 minutes duration at Medium
intensity (followed by a 10 second pause)
– Vibration mode, 10 minutes duration at Medium
intensity (followed by a 10 second pause)
– Drainage mode, 10 minutes duration at Medium intensity
The AoVest will start in the Medium intensity mode by
default. Pressing the following buttons will update the
treatment whether the vest is running or not:
High intensity
Medium intensity
Low Intensity
While treatment is running, the AoVest may be paused
by pressing the (Play/Pause) button. This shall
suspend treatment until the (Play/Pause) button is
pressed again.
While paused, press and hold the (Play/Pause) button
to reset the treatment time to the previous setting.

10
Indicators
The Main Menu for the AoVest contains the following
indicators to provide the user with useful information:
Zone Indicator: Displays which motor zones are currently
active during treatment.
Low Battery Indicator: When the battery is low, a battery
icon will ash alerting the user. The controller will also
beep to alert the user to charge the battery.
The battery for the AoVest contains the following
indicators to provide the user with useful information:
Fuel Gauge: Displays the battery level when the button
is pressed.
Menu Navigation
Press the (Up) and (Down) buttons to navigate
through menus on the controller. To change the value,
press the (Left) and (Right) buttons while the value
is highlighted.
To navigate to the Program Menu or Usage Menu, navigate
to the desired menu selection. Press the (Play/Pause)
button to navigate to that menu.