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The AffloVest is intended for use in the electromagnetic environment specified below  The customer or user of the  
AffloVest should ensure that it is used in such an environment 

INTERFERENCE 

IMMUNITY TESTS

IEC 60601-TEST 

LEVEL

COMPLIANCE   

LEVEL

ELECTROMAGNETIC ENVIRONMENT GUIDELINES

Conducted RF 

interference as per IEC 

61000-4-6

3 V

rms

 150 kHz  

to 80 MHz

3 V

rms

Portable and mobile RF communications equipment should be 

used no closer to any part of the AffloVest, including the cables, 

than the recommended distance calculated from the equation 

applicable to the transmit frequency 
Recommended distance:  

d = 1 2 m P
d=1 2 m P for 80 MHz to 800 MHz d=2 3 m P for 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 distance in meters (m)  The field strength of fixed RF 

transmitters, as determined by an electromagnetic site survey(a) 

should be less than the compliance level in each frequency 

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 range applies at 80 MHz and 800 MHz.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons.

(a) The field strength from fixed transmitters, such as base stations for radio telephones and mobile terrestrial radio equipment, amateur radio stations, AM and FM radio 
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment in terms of fixed RF transmitters, an electromag-
netic site survey should be considered. If the measured field strength in the location in which the AffloVest is used exceeds the applicable compliance level specified above, 
the AffloVest should be observed to verify normal operation. If abnormal performance features are observed, additional measures may be necessary, such as re-orienting 
or relocating the AffloVest.

(b) The field strength should be less than 3 V/m over the frequency range from 150 kHz to 80 MHz.

Содержание AFFLOVEST

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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