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Indications for Use/Method/
Application

Indications for Use

The AffloVest 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 AffloVest 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 AffloVest may be prescribed for one of these 
conditions*:

  Bronchiectasis

  Cystic fibrosis

  

Late effects of poliomyelitis

  

Other deficiencies 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 AffloVest  
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 AffloVest

Carefully unpack the AffloVest and its accessories  

Package contents:

AffloVest

Rechargeable Battery  

(Li-ion)

Power Supply

Carrying Case

User Manual

Summary of Contents for AFFLOVEST

Page 1: ...AffloVest Instructions for Use and User Manual Frees patients Mobilizes secretions Advances therapy...

Page 2: ...Minneapolis MN 55416 USA Toll Free Tel 800 575 1900 Toll Free Fax 866 569 1912 afflovest com Welcome to AffloVest Dear Customer Congratulations on your purchase of an AffloVest from Tactile Medical W...

Page 3: ...t 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...

Page 4: ...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 800 575 1900 Toll Free...

Page 5: ...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 Bronchopleura...

Page 6: ...us present in the air pathways in compliance with a physician s prescription and orders Application The AffloVest may be prescribed for one of these conditions Bronchiectasis Cystic fibrosis Late effe...

Page 7: ...upply plug into the AffloVest 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 clos...

Page 8: ...ttery comes connected inside of the battery pouch The battery should not require disconnection or removal from the AffloVest during normal use The serial number tag is included inside the battery pouc...

Page 9: ...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 programm...

Page 10: ...to alert the user to charge the battery The battery for the AffloVest contains the following indicators to provide the user with useful information Fuel Gauge Displays the battery level when the butto...

Page 11: ...Treatment Time 5 15 Minutes Treatment Intensity Low Medium High Select Save and press the Play Pause button to save the settings To exit without saving select Cancel and press the Play Pause button T...

Page 12: ...the following Keep the AffloVest dry Protect the AffloVest from direct sunlight Remove the battery from the AffloVest during transport storage Keep the AffloVest between 20 C without relative humidity...

Page 13: ...racing the outer edges all the way around the AffloVest and repeat b Wipe all exposed fabric thoroughly pressing into creased areas and repeat 4 Turn AffloVest over and lay it flat a Starting at the t...

Page 14: ...problems Do not attempt to open the battery case The electrolytes and electrolyte vapors contained within the case of Lithium ion batteries may be harmful to humans If the battery case breaks or is co...

Page 15: ...eaning with any type of liquid disinfectant or cleaning solution Never put the AffloVest cords over sharp edges Never allow cords on the AffloVest to kink or bind Never carry or lift the AffloVest by...

Page 16: ...ely deposit them at municipal collection points for recyclable materials where they will be accepted free of charge Correct disposal of products will help protect the environment and avoid harmful eff...

Page 17: ...d to the AffloVest correctly Attempt to operate the AffloVest when connected to the power supply Contact your dealer for further assistance The selected program function has suddenly switched off The...

Page 18: ...ry From the AffloVest Wait sixty 60 seconds and reconnect battery The battery will beep twice when the battery is plugged back in Open battery compartment and disconnect battery as shown leave disconn...

Page 19: ...tic material the relative humidity should be at least 30 Fast Electrical Transients Bursts as per IEC 61000 4 4 2 kV for Power Supply Lines 1 kV for Input Output Lines 2 kV for Power Supply Lines 1 kV...

Page 20: ...ncy range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF interference as per IEC 61000 4 3 3 V m 80MHz to 2 5 GHz 3 V m NOTE 1 The higher frequency...

Page 21: ...DISTANCE DEPENDENT ON TRANSMIT FREQUENCY M 150 kHz to 80 MHz d 1 2 m P 80 MHz to 800 MHz d 1 2 m P 800 MHz to 2 5 GHz d 2 3 m P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100...

Page 22: ...AFFLOVEST IN NO EVENT SHALL TACTILE MEDICAL BE LIABLE FOR ANY SPECIAL DIRECT INDIRECT OR CONSEQUENTIAL DAMAGES Some states provinces or countries do not allow exclusion or limitation of incidental or...

Page 23: ...chasers are those original end user Purchasers who first took possession of the warranted item in the United States of America its possessions or territories for use of that item in the United States...

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