International Biophysics AffloVest User manual

Dear Customer,
Congratulations on your purchase of an AffloVest from International Biophysics
Biophysics!! We are excited to bring you a new level of freedom
while complying with the therapeutic requirements of your health professional. Thank you for placing your trust with us. To eensure
nsure
that you derive maximum benefit from the AffloVest and to ensure your sa
safety,
fety, please familiarize yourself with the information in this
AffloVest User Manual.
The AffloVest
AffloVest User
User Manual
Manual contains
contains important SAFETY
SAFETY and
and TECHNICAL
TECHNICAL DATA.
DATA. Please
Please keep
keep this
this manual
manual in
in a safe
safe place for
for easy
reference.
With proper care and maintenance, the AffloVest will reward you with a long, trouble
trouble-free
free service life. We greatly value the
satisfaction of our Customers and hope you are completely satisfied with your AffloVest by International Biophysics Corporati
Corporation.
on.
For assistance setting up or using the AffloVest, or to report unexpected operation or events please contact Inter
International
national Biophysics
Corporation, or the local DME that supplied you with the AffloVest.
EXPLANATION OF SYMBOLS
Symbol
Explanation
Symbol
Explanation
Caution
Stand
Stand-by
by
Type BF Equipment - All parts considered applied parts
Play/Pause
Direct Current
High Intensity
Manufacturer
Medium Intensity
Reference Number
Low Intensity
Lot Number
Do not machine wash
Serial Number
Do not bleach
Refer to Instructions for Use
Do not tumble dry
Keep dry
Do not iron
Waste electrical and electronic equipment; do not dispose
in household waste. Dispose of equipment in accordance
with all relevant local, state and federal regulations.
Do not wet clean
DFU 022 Rev A
TECHNICAL DATA
Nominal Voltage:
Nominal Power Consumption:
Battery Charger:
12V
12VDC
DC
Approx. 30W max
See the Battery Charger User Manual, included in package.
A/C Power Supply
Supply:
See the A/C Power Supply User Manual, included in package.
The provided power supply is specified as part of the AffloVest system
Lithium
Lithium-ion
ion Battery:
MODEL: 8027
OUTPUT: 14.4VDC, 2.5A typ. Li
Li-ion
ion
CHARGING VOLTAGE
VOLTAGE:: 16.8VDC, 3.5A max
Manufacturer:
International Biophysics Corporation
2101 E. St. Elmo Ro
Road,
ad, Building 2, Suite 275
Austin, TX 78744 USA
www.afflovest.com
888
888-711
711-1145
1145
Sizes:
XXS (Extra Extra Small)
XS (Extra Small)
S (Small)
M (Medium)
L (Large)
XL (Extra Large)
XXL (Extra Extra Large)
TRANSPORTATION, OPER
OPERATION
ATION AND STORAGE CONDITIONS
Please observe the following during transportation, storage and operation of the AffloVest product.
Storage and Transport Conditions Between Uses
In between uses, please observe the following:
•
•
•
•
Keep the AffloVest dry
Protect the AffloV
AffloVest
est from direct sunlight
Remove the battery from the AffloVest during transport/storage
Keep in the AffloVest between --20°° C (without relative humidity control) and 50
50° C (93% relative humidity, non
non-condensing)
condensing)
Operating Conditions
While using the AffloVest, please observe the following:
•
•
•
Keep the AffloVest dry
Protect the AffloVest from direct sunlight
Keep the AffloVest between 5
5° C - 35°° C, 15 - 93% relative humidity (non
(non-condensing)
condensing) and 700 - 1060 hPa.
SAFETY FEATURES
•
The AffloVest was designed with maximum safety in mind, therefore it contains the following safety features:
o
o
o
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
shut-off.
off.
DFU 022 Rev A
USER INFORMATION
IMPORTANT!
The AffloVest should be worn over clothing or with a fabric shield to prevent cross
cross--contamination
contamination in a clinic or hospital setting where
more than one patient uses the unit. The AffloVest should be cleaned appropriately between patient use, see the Cleaning Section.
According to the American Association for Respiratory Care (AARC) Guidelines for Postural Drainage Therapy, the decision to uuse
se
the unit for Airway Clearance Therapy requires ccareful
areful 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 fistula
Pulmonary edema associa
associated
ted with congestive heart failure
Large pleural effusions or empyema
Pulmonary embolism
Acute illness
Pregnancy or nursing mothers
Electronic implants
Rib fractures, with or without flail chest
Surgical wound or healing tissue or recent skin grafts or flaps 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
Coagulopath
Coagulopathyy
Complaint of chest wall pain
INDICATIONS FOR USE/METHOD/APPLICATI
USE/METHOD/APPLICATION
ON
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 oof
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 complia
compliance
nce with a
physician’s prescription and orders.
APPLICATION
The AffloVest can be used, per a physician’s prescription, in the treatment of a variety of conditions and diseases, including genetic
genetic,
neuromuscular and
and immunological
immunological disorders
disorders causing
causing chronically
chronically compromised
compromised airway
airway clearance.
clearance. Among the
the most
most common
common are cystic
cystic
fibrosis, cerebral palsy, bronchiectasis, ALS, Muscular Dys
Dystropy
tropy and Multiple Sclerosis.
DFU 022 Rev A
UNPACKING AND USING THE AFFLOVEST FOR TH
THE
E FIRST TIME
ATTENTION!
Please follow the STEPS in order to ensure proper set
set-up.
up.
Battery must be fully charged before use (this is covered in the STEPS below).
PACKAGE CONTENTS
AffloVest
Rechargable Battery (Li-Ion)
Ion)
AC Power Supply
Controller
Battery Charger
Carrying Case
STEP 1 – UNPACKING THE AFFLOVEST
Carefully unpack the AffloVest and its accessories.
You must fully charge the battery before proceeding to STEP 3.
DFU 022 Rev A
STEP 2 - CHARGING THE BATTERY
Use only the supplied rechargeable battery and the supplied battery charger to ensure safe and reliable
operation of the AffloVest.
•
The battery must be fully charged before using the AffloVest for the first time.
•
To charge the battery, connect it to the battery charger unit.
o
When charging, the Red LED on the battery charger will illuminate.
o
When fully charged, the Red LED on the battery charger changes to Green.
Battery charging - Red LED
•
Battery fully charged - Green LED
When the battery charger LED changes from Red to Green unplug the battery charge
chargerr and proceed to the next STEP.
STEP 3 – CONNECTING THE CONTROLLER TO THE AFFLOVEST
•
•
•
Insert the hand
hand-held
held controller into its pocket on the left side of the AffloVest.
Carefully align and plug the controller connector into the cable coming
from the AffloVest. Verify the arrows match before connecting.
Make sure the controller cable connectors are fully inserted into one another.
STEP 4 – CONNECTING THE BATTERY OR A//C
C POWER SUPPLY TO THE AFFLOVEST
•
Insert the fully charged battery into its pocket on the right side of the AffloVest and connect it to the power cable coming
from the vest.
•
Make sure the battery power cable connector is fully inserted into the battery. Note: The motors may vibrate briefly when
first plugging the AffloVest into power.
DFU 022 Rev A
•
The
he AC Power Supply may be used to power the AffloVest instead of the battery
battery.. Connect the AC Power Supply to the
AffloVest by plugging the AC Power Supply into a wall ou
outlet.
tlet. Connect the AC Power Supply to the power cable coming
from the vest.
A/C Power Supply - Connected to wall outlet
A/C Power Supply - Connected to AffloVest
YOUR AFFLOVEST IS NOW READY FOR USE!
IMPORTANT!
•
Unplug the battery charger from outlet when not in use.
•
If the battery has not been used for over 30 days, please recharge prior to using
using..
DFU 022 Rev A
FITTING THE AFFLOVES
AFFLOVEST
T
•
Unbuckle the chest buckles on the AffloVest and set the buckles to maximum size.
•
Put on the AffloVest and fasten all 3 buckles. Firm
Firmly
ly pull the buckle straps so that the vest fits snugly on the body, but does not restrict
a deep, full breath. Adjust the straps until there is only an approximate 1” to 5” gap between the two sides of the AffloVest.
•
Adjust the shoulder snaps to place the front upper AffloVest motors on the upper chest just below the collar bone.
CONTROLLER LAYOUT
Press and hold to turn Controller ON and OFF
(Stand
(Stand-By)
By)
GO
P V D
Press to start pre
pre-programmed
programmed GO sequences
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
Press to navigate through menu items
(Up/Down)
Press to change current highlighted selection
(Left/Right)
DFU 022 Rev A
RUNNING A TREATMENT CYCLE
•
When the AffloVest is properly setup, press and hold the Standby (
) button on the controller. After a brief start
start-up
up period, the
controller will navigate to the main treatment menu.
Figure 2 – Main Treatment Menu
Figure 1 – Welcome Screen
•
Treatment may be started at any time by hitting the
button (Play/Pause) from the main treatment menu. Pressing the following
buttons will update the treatment whether the vest is running or not.
•
o
"P" - Percussion mode, all motors operate in a pulsed fashion.
o
"V" - Vibration mode, all motors operate continuously
continuously..
o
"D" - Drainage mode, motors operate in a pre
pre-programmed
programmed sequential fashion
fashion.
o
"GO"
GO" - Automatically starts the GO mode, the system will perform the following treatments sequentially (by default)
default):
Vibration mode, 10 minutes duration at Medium intensity (followed by a 10 second pause)
Drainage mode, 10 minutes duration at Medium intensity
o
- HIGH intensity
o
- MEDIUM intensity
- LOW Intensity
While treatment is running, the AffloVest may be paused by pressing the
until the
•
Percussion mode, 10 minutes duration at Medium intensity (followed by a 10 second pause)
The AffloVest will start in the Medium intensity mode by default. Pressing the following buttons will update the treatment whether the
vest is running or not
not:
o
•
button (Play/Pause)
(Play/Pause).. This shall suspend treatment
button is pressed again.
While paused, press and hold the
button to reset the treatment time to the previous setting.
INDICATORS
•
The Main Menu for the AffloVest contains the following indicators to provide the user with useful information:
o
Battery Indicator - Displays an approximate battery life. When the battery indicator begins flashing, remove the battery and
charge fully.
o
Zone Indicator - Displays which motor zones are currently active during treatment.
MENU NAVIGATION
•
Press the "UP" and "DOWN" buttons to navigate through menus on the controller. To change the value, press the "RIGHT" and
DFU 022 Rev A
"LEFT" buttons while the value is highlighted.
•
To navigate to the Program Menu or Usage Menu, navigate to the desired menu selection. Press the
button to navigate to that
menu.
PROGRAM MENU
PROGRAM
•
Navigating to the Program Menu allows the user to modify the default GO treatment settings.
Figure 3 – Program Menu
•
Modify the settings as desired within the following allowable ranges:
o
Treatment Type: Percussion, Vibration, Drainage
o
Treatment Time: 5 - 15 Minutes
o
Treatment Intensity: Low
Low,, Medium, High
•
Select "Save" and press the
button to save the settings. To exit without saving select "Cancel" and press the
•
The next time the "GO" button is pressed from
m the Main Menu the new treatment settings will be run.
button.
USAGE MENU
•
Navigating to the Usage Menu allows the user to view run
run-time
time information
information.
Figure 4 – Usage Menu with Run
Run--Time
Time Information
•
Press the
button to return to the Main Menu.
TURNING OFF THE AFFL
AFFLOVEST
OVEST
•
To turn off the AffloVest controller, press and hold the Standby (
) button for at least two (2) seconds. The system will enter a
standby mode.
•
Alternatively, to turn off the AffloVest controller, remove the power by either disconnecting the battery or A/C power supply.
DFU 022 Rev A
CLEANING THE AFFLOVE
AFFLOVEST
ST
Clean the AffloVest in the following situations:
•
When the Af
AffloVest
floVest becomes visibly soiled
•
B
Between
etween patient uses in multi
multi-patient
patient care environments, we recommend cleaning the AffloVest.
•
In a single
single-user
user environment; it is recommended that the AffloVest be cleaned monthly.
To clean the AffloVest, please utilize a broad
broad-spectrum
spectrum disinfecting wipe rrated
ated to kill at least 99.9% of bacteria and viruses and follow the
manufacturer’s instructions for use. Using appropriate protective equipment, including disposable latex
latex-free
free gloves, follow the instructions
below to clean the AffloVes
AffloVestt using the disinfect
disinfecting
ing wipes. Follow the disinfecting wipe label with regards to concentration, contact time,
rinsing and drying after cleaning.
1) Ensure the AffloVest is unplugged from all power sources.
2) Unbuckle battery and controller flaps
a. Disconnect and remove battery from AffloVest pouch
b. Disconnect and remove controller from AffloVest pouch
3) Unbuckle front buckles and shoulder snaps and lay AffloVest flat so that the inside of AffloVest is exposed
a. Wipe the outer edges of the Affl
AffloVest,
oVest, starting in the collar area, tracing 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 top, wipe the exposed AffloVest fabric thoroughly,
pressing into creased areas, and repeat.
b. Wipe male and female snaps.
c. Wipe buckles and straps on each side.
i. Make sure to wipe inside female connector of buckle.
ii. Make sure to wipe ridges on male co
connector
nnector of buckles.
d. Wipe battery flap and the inside and outside of battery pouch.
e. Wipe battery cable protruding from AffloVest.
f. Wipe controller flap and the inside and outside of controller pouch.
g. Wipe controller cable protruding from Aff
AffloVest.
loVest.
5)
6)
7)
8)
Wipe battery thoroughly.
Wipe controller thoroughly.
Wipe all accessories thoroughly including all cables.
Wipe carry case thoroughly (inside and outside).
CLEANING AND CARE WA
WARNINGS
RNINGS
Do not machine wash
Do not bleach
Do not tumble dry
Do not iron
Do not wet clean
DFU 022 Rev A
BAT
BATTERY
ERY WARNING
ARNING INFORMA
INFORMAT
TION
ION
•
The battery must never be thrown into a fire or incinerated.
•
The battery must not be immersed in liquids, such as water, sea water, or beverages. Contact with liquids must be avoided.
•
The battery is not a toy and must be kept away from young children and babies.
•
The battery must not be placed in a microwave or subjected to pressure. It may combust, resulting in smoke and fire.
•
The battery must not be dropped onto a hard surface
surface.
•
Never dismantle the battery, as this may cause internal short
short-circuits,
circuits, resulting in gas emissions, fire and explosion, or other
problems.
•
The electrolytes and electrolyte vapors contained within the case of lithium
lithium-ion
ion batteries may be harmful to humans
humans. DO NOT
ATTEMPT TO OPEN THE BATTERY CASE
CASE.. If the battery case breaks or is compromised, avoid direct contact with the
electrolytes within. If electrolytes come in contact with the skin, eyes or other parts of the body, immediately flush or rin
rinse
se with
fres
fresh
h water and seek medical attention as soon as possible.
•
Store battery on a non
non-combustible,
combustible, heat resistant and non
non--conductive
conductive surface.
•
Do not expose the battery to direct sunlight.
SAFETY INFORMATION
The AffloVest is certified with the standard EN 60601 and corresponds to the Medical Devices Directive 93/42EEC:
THE MANUFACTURER,
MANUFACTURER, INTERNATIONAL
INTERNATIONAL BIOPHYSICS CORPORATION,
CORPORATION, SHALL
SHALL ACCEPT
ACCEPT NO LIABILITY WHATSOEVER
WHATSOEVER FOR
FOR
ANY DAMAGE AND/OR CONSEQUENTIAL DAMAGE RESULTING FROM NON
NON-COMPLIANCE
COMPLIANCE WITH THE FOLLOWING
SAFETY INFO
INFORMATION.
RMATION.
•
Repairs to the AffloVest or its electrical components may only be carried out by International Biophysics Corporation
authorized electricians or service dealers. Unauthorized repairs will void the AffloVest warranty and may place the user at
considerable risk or damage the AffloVest.
•
There are no parts of the AffloVest which are intended to be serviced or maintained while the AffloVest is in use with the
patient. Do not service or perform maintenance while tthe
he AffloVest is in use.
•
The patient is intended to be an operator for the AffloVest. All functions of the AffloVest may be safely used by the patient
patient..
•
The expected service life of the AffloVest, including all accessories, is five (5) years.
THE MANUFACTURE
MANUFACTURER,
R, INTERNATIONAL BIOPHYSICS CORPORATION,SHALL NOT BE LIABLE FOR ANY DAMAGE AS A
RESULT OF: 1) THE AFFLOVEST BEING USED FOR ANYTHING OTHER THAN ITS INTENDED PURPOSE, 2) INCORRECT
USE, OR 3) IMPROPER REPAIR RESULTING FROM HAVING THE AFFLOVEST REPAIRED BY AN
ANYONE
YONE THAT IS NOT AN
INTERNATIONAL BIOPHYSICS CORPORATION AUTHORIZED REPAIR FACILITY OR TECHNICIAN.
•
WARNING: No modification of this equipment is allowed.
•
To protect the AffloVest from potential damage, avoid leaving in direct sunlight for extended periods of time and keep the
AffloVest clean of debris such as lint or dust. In addition, avoid leaving the AffloVest in areas where it may be damaged by
pets, pests or children.
•
To avoi
avoid
d a potential strangulation hazard for small children, properly store the AC power supply in between uses.
•
To avoid potential skin irritation, it is recommended to wear the AffloVest over comfortable clothing.
•
The AffloVest may only be used with the includ
included
ed accessories
accessories. Do not use unapproved accessories with the AffloVest.
•
The battery may only be charged with the supplied battery charger in accordance with the charger instructions. The use of
any other power supply units or chargers may lead to fire and el
electric
ectric shock and will void the AffloVest Warranty.
•
Always unplug the AffloVest when not in use.
DFU 022 Rev A
•
Unplug the AC power supply if the AffloVest malfunctions while powered by AC current.
•
Always unplug the AffloVest from wall outlet
outlet,, and remove the battery and the hand
hand-held
held controller before cleaning with any
type of liquid disinfectant or cleaning solution.
•
Never disconnect the power plug from an electrical outlet with wet hands.
•
Never pull the AffloVest power cords or cable over sharp edges or allow them to kkink
ink or bind.
•
Never carry or lift the AffloVest by any of its electrical cables or components.
•
Children and disabled persons should not use the AffloVest without supervision.
•
Do not use the AffloVest in damp environments, such as in the bathroom or at a swi
swimming
mming pool. Do not puncture the
AffloVest with sharp objects, such as pins or needles.
ENVIRONMENTAL PROTEC
PROTECTION
TION
Electrical
lectrical and electronic products must be disposed of separately from any household waste at the end of their service. To ens
ensure
ure
that these products are recycled effectively, 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 effects to human beings and the environment that
may arise from incorrectly handling devices at the end of their service life. Please contact local authorities to determine the proper
method of disposal.
TRAVELING WITH LITHI
LITHIUM
UM-ION
ION BATTERIES
Lithium
Lithium-ion
ion batteries can be considered ha
hazardous
zardous by the FAA. Familiarize yourself with any travel guidelines before you travel.
Contact your carrier or visit their website for guidance.
PREVENTIVE INSPECTIO
INSPECTION,
N, CALIBRATION, AND MAINTENANCE
On a periodic basis, the AffloVest should be cleaned as described in the Cleaning section. After cleaning, it is recommended to
inspect the AffloVest for any damage to the product, wiring, battery, accessories and the controller. This may be performed bbyy the
user or by authorized service p
personnel.
ersonnel. If any damage is noted, please contact the manufacturer for assistance.
The AffloVest is designed to operate without any periodic calibration or maintenance required. Only the manufacturer may replace
parts or perform repair on the AffloVest.
DFU 022 Rev A
TROUBLESHOOTING
IMPORTANT
Before attempting any troubleshooting, ensure that the battery is fully charged. To check the battery charge level, connect the
battery to the Battery Charger and plug the charger into a wall outlet. Wait 30 seconds. If the indicator on the Battery Charger is
GREEN, the battery is fully charged. If the indicator is RED, allow the battery to charge until the indicator turns GREEN.
SYMPTOM
AffloVest controller
will not power on
when connected to
battery
POSSIBLE CAUSE
Battery discharged
TROUBLESHOOTING STEPS
Ensure battery is fully charged
OR
Battery not connected
properly
Verify that the battery is connected to the AffloVest
correctly
OR
Possible damaged
controller
Attempt to operate the AffloVest when connected to
the AC Power Supply
OR
Contact your dealer for further assistance.
Possible damaged
battery
AffloVest controller
will not power on
when connected to
AC Power Supply
AC Power Supply not
connected to power
Ensure AC Power Supply is connected to a working
outlet
OR
AC Power Supply not
connected properly
Verify that the AC Power Supply is connected to the
AffloVest correctly
OR
Possible damaged
controller
Attempt to operate the AffloVest when connected to
a fully charged battery
OR
Possible damaged AC
Power Supply
The selected
program function
has suddenly
switched off.
The therapy cycle has
finished and a new
therapy cycle must be
started.
Contact your dealer for further assistance.
Start a new therapy cycle.
OR
Battery discharged.
Charge battery or switch to the AC Power Supply.
DFU 022 Rev A
ELECTROMAGNETIC GUILDEINES FOR CLINICAL APPLICATIONS
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.
EMITTED INTERFERENCE
CONFORMITY
MEASUREMENT
ELECTROMAGNETIC ENVIRONMENT
GUIDELINES
RF emissions as per CISPR 11
Class B
The AffloVest is suitable for use in all
establishments, including domestic, and those
directly connected to the public power supply
network that supplies buildings used for domestic
Harmonic component emissions as per IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions as per IEC 61000-3-2
Compliant
purposes.
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
IEC 60601-TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT
TESTS
LEVEL
LEVEL
GUIDELINES
Electrostatic discharge (ESD)
as per IEC 61000-4-2
±6 kV Contact Discharge
±6 kV Contact Discharge
±8 kV Air Discharge
±8 kV Air Discharge
Fast Electrical
Transients/Bursts as per IEC
61000-4-4
±2 kV for Power Supply Lines
±2 kV for Power Supply Lines
±1 kV for Input/Output
±1 kV for Input/Output Lines
Floors should be wood, concrete, or ceramic
tile. If floors are covered with a synthetic
material, the relative humidity should be at
least 30%
Mains power quality should be that of a
typical commercial or hospital environment
Lines
Surge Voltages (Surge) as per
IEC 61000-4-5
±1 kV Normal-Mode Voltage
±1 kV Normal-Mode Voltage
±2 kV Common-Mode
±2 kV Common-Mode Voltage
Mains power quality should be that of a
typical commercial or hospital environment
Voltage
DFU 022 Rev A
EVoltage Dips, Short- Term
Interruptions and Fluctuations in
Supply Voltage as per IEC
61000-4-11
<5% Ut (>95% dip in Ut) for 0.5 cycle
<5% Ut (>95% dip in Ut) for 0.5
cycle
40% Ut (60% dip in Ut) for 5 cycles
40% Ut (60% dip in Ut) for 5 cycles
0% Ut (30% dip in Ut for 25 cycles
0% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip Ut for 5 s
<5% Ut (>95% dip Ut) for 5 s
Power Frequency (50 Hz)
Magnetic Field as per IEC
61000-4-8
3 A/m
3 A/m
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the AffloVest requires
continued operation during interruptions in
the power supply, it is recommended that
the AffloVest be powered from an
uninterruptible power supply or battery
Power frequency magnetic fields should be at
levels characteristic of a location in a
commercial or hospital environment
NOTE: Ut is the mains AC voltage prior to application of the test level.
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
Conducted RF interference as per
IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
ELECTROMAGNETIC ENVIRONMENT GUIDELINES
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
Radiated RF interference as per
IEC 61000-4-3
3 V/m 80MHz to 2.5 GHz
3 V/m
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.
DFU 022 Rev A
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
electromagnetic 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.
Recommended distances between portable and mobile RF telecommunications equipment and the AffloVest.
The AffloVest is intended for use in an electromagnetic environment, in which RF interference is controlled. The customer or user of the AffloVest can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the AffloVest as
recommended below - dependent on the maximum output power of the communications equipment.
Distance Dependent on Transmit Frequency (m)
Nominal Transmitter
Output (W)
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
12
12
23
The recommended distance d in meters (m) for transmitters with a maximum nominal output not specified in the table above can be calculated using the equation
applicable to the transmitter frequency (in the specific column in the table), where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
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, object and persons.
DFU 022 Rev A
AFFLOVEST®
LIMITED LIFETIME WARRANTY
International Biophysics Corporation (“IBC”) warrants to the original end-user purchaser (“Purchaser”) and not to any
other purchaser or subsequent owner, that the AffloVest® purchased from IBC or its authorized distributor or dealer is free
from defects in design, material and workmanship under normal use and operation, for the lifetime of the Purchaser,
except as expressly limited below. Accessories, controller and batteries for the AffloVest® are warranted solely to be free
of defects for a period of five (5) years from the date of original purchase by Purchaser, except for the AffloVest “Go
Anywhere” case, which is warranted solely to be free of defects for a period of one (1) year from the date of original
purchase.
UNDER THIS WARRANTY, IBC’S OBLIGATION IS LIMITED TO THE REPAIR OR REPLACEMENT (AT IBC'S
OPTION) OF DEFECTIVE ITEMS ONLY. Reimbursement for the cost of return are not included. IBC may, in its sole
discretion, refund the purchase price of the warranted item in lieu of repair or replacement, but IBC will never be
obligated to do so. This Limited Warranty excludes any damage, failure or malfunction caused by or related to:
 Abuse, misuse, negligence or accident
 Failure to comply with instructions contained in the Operator's Manual
 Operation of the battery pack outside of voltage and current ratings specified in the Operating Manual
 Alteration, tampering, or modification by someone other than an authorized IBC representative
 Unauthorized repairs or alterations or opening of the inside of device
 Extreme or unusual environmental conditions (including but not limited to extreme heat or cold or water damage)
 Lack of regular, preventative maintenance and cleaning
 Damage in return shipment to IBC
 Other acts beyond the reasonable control of IBC
This Limited Warranty extends only to the Purchaser identified above and is not transferable except upon IBC’s prior
written consent. IBC’s warranty obligations hereunder are conditioned upon Purchaser's compliance with the warranty
procedures set forth below. If any warranted item fails to conform to the Limited Warranty set forth herein, Purchaser
must give prompt timely written notice to IBC, including a detailed description of the alleged fault or defect, at which
time IBC or its authorized distributor will issue a Return Material Authorization (“RMA”) number. All warranted items
claimed to be defective must be properly packaged and shipped on a prepaid basis to IBC or its authorized distributor at
Purchaser’s expense. The exterior of the shipping container must clearly display the RMA number which properly
identifies the returned item, which must include the invoice or other proof of purchase and identity of the Purchaser.
Items returned without a proper RMA number and proof of purchase shall be refused and returned to Purchaser at
Purchaser’s expense. All returned items are subject to warranty confirmation by IBC, which shall pay for standard
shipment back to Purchaser for repair or replacement of items properly covered under this Limited Warranty.
When repairing or replacing warranted items, IBC may use functionally equivalent components or parts, as long as they
are new, equivalent to new or refurbished. Any components or parts removed by IBC in the repair or replacement of any
warranted item shall become IBC’s property.
To the extent permitted by applicable law, the warranty coverage will not be extended or renewed by virtue of IBC’s
compliance with this Limited Warranty. Any components or parts which are repaired or replaced will be warranted for
the unexpired term of the Limited Warranty.
ANY IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR USE, ARE LIMITED TO THE TERM OF THE APPLICABLE EXPRESS
WARRANTY PROVIDED HEREUNDER. IBC IS NOT RESPONSIBLE FOR INJURY, PROPERTY DAMAGE OR
OTHER INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OF THE
AFFLOVEST®, NOTWITHSTANDING THE FACT THAT SAID INJURY, PROPERTY DAMAGE OR OTHER
DAMAGES AROSE DIRECTLY OR INDIRECTLY FROM AN ACTUAL OR ALLEGED DEFECT IN MATERIAL
AND/OR WORKMANSHIP.
SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS
OR THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE
LIMITATIONS AND EXCLUSIONS MAY NOT APPLY TO YOU.
This Limited Warranty gives you specific legal rights, and you may also have other rights, which vary from state to state.
AffloVest® is a registered trademark of IBC. This Limited Warranty is the exclusive responsibility of IBC and is given in
lieu of all other warranties or assurances. Claims hereunder may be presented only to IBC or its authorized distributor.
This Limited Warranty may not be expanded or modified by anyone (including but not limited to any authorized
distributor) except in writing by an authorized officer of IBC.
DFU 022 Rev A
The rights and obligations of the parties pursuant to this Limited Warranty and any dispute arising hereunder shall be
governed by and interpreted in accordance with the internal laws of the State of Texas. The parties agree and consent
that the state or federal courts in Travis County, Texas shall have exclusive jurisdiction with respect to any dispute
arising out of or relating to this Limited Warranty, whether sounding in contract, tort or otherwise. If any
provision of this Limited Warranty is held to be illegal or unenforceable, that provision will be limited or eliminated to the
minimum extent necessary so that this Limited Warranty will otherwise remain in full force and effect and enforceable.
EACH PARTY EXPRESSLY WAIVES ALL RIGHTS TO A TRIAL BY JURY.
Description
Warranty Time
AffloVest (XXS, XS, S, M, L, XL, XXL)
AffloVest and oscillation motors have a Limited
Lifetime Warranty per above warranty policy
A/C Power Supply
(used to power the AffloVest from electrical outlet)
Battery Charger
(used to charge the AffloVest battery from electrical outlet)
5 years
Rechargeable Lithium-Ion Battery
Hand-held Controller
AffloVest “Go Anywhere” Case
1 year
DFU 022 Rev A