AffloVest RP8300 User manual

SCOPE OF DELIVERY/PARTS
Hand-held Controller
RP8004
Power Supply Unit/Charger
RP8001
Rechargeable Battery
RP8003
AffloVest
L - RP8300
M - RP8200
S - RP8100
Carrying Case
RP8005
AffloVest Instructions for Use
Adapter Cable for D/C Operation
RP8002
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Dear customer,
Thank you for choosing this product and the trust you have placed in us with your purchase. To
ensure that you are able to fully utilize all of the advantages offered by our product, we have
compiled the information you will need in order to optimally use your AffloVest in this manual. To
ensure the safe use of this device, please pay particular attention to all of the points identified in
this booklet.
The instructions for use also contain important information on SAFETY and TECHNICAL
DATA. You should therefore carefully read the instructions before using the device for the first
time and keep these instructions in a safe place for future reference.
With proper maintenance and care, you will be rewarded by your AffloVest with a long service
life and trouble-free operation of our product. We greatly value the satisfaction of our customers
and hope you are happy with your AffloVest by IBC.
CONTENTS
Explanation of Symbols .......................................................................................... Page 4
Technical Data ................................................................................................................... Page 5
User Information ................................................................................................................ Page 6
Purpose/Method/Application .............................................................................................. Page 6
Starting the AffloVest in Battery Mode ............................................................................... Page 7
Battery Warning Information .............................................................................................. Page 8
Technology and Design ..................................................................................................... Page 8
Buttons and Functions ...................................................................................................... Page 9/10
Body Zones ....................................................................................................................... Page 10
Test Regulations for Commercial/Clinical Use .................................................................. Page 11
Safety Information ............................................................................................................. Page 11
Guarantee of the Battery Pack .......................................................................................... Page 12
Environmental Protection .................................................................................................. Page 13
Turning Off Device............................................................................................................. Page 13
Cleaning and Care ............................................................................................................ Page 13
Troubleshooting ................................................................................................................ Page 14
Electromagnetic Guidelines for Clinical Applications ........................................................ Page 15/17

EXPLANATION OF SYMBOLS
Test and Identification Symbols - AffloVest
TÜV Symbol - A Tested Medical Product
CE Mark - A European Conformity Symbol for Medical Products
Body Floating (Not Grounded/Earthed)
Direct Current (DC Power)
Alternating Current (AC Power)
Test and Identification Symbols - RP8001 Power Supply Unit/Charger
Test and Identification Symbols - RP8003 Battery Pack
Not for Outdoor Use
TÜV Rheinland Approval - In Accordance with EN60601-1
and IEC 60601-1
Communané Européenne (European Community) - Directives
governing electrical and electronic devices
FCC is the American Test Symbol for Electromagnetic Compatibility,
issued by the Federal Communications Commission
Recognized Component Mark - American Test Symbol for American
and Canadian Markets
Recycling Symbol
Electronic Scrap - Do not Dispose of in Household

Communané Européenne (European Community) - Directives
governing electrical and electronic devices
Attention! Read Operating Instructions Before Use!
Do Not Short-Circuit!
Do Not Place Near Or Into Fire!
Do Not Submerge In Water!
TECHNICAL DATA
Nominal Voltage:
Nominal Power Consumption:
Power Supply Unit/Charger:
Lithium Polymer Battery Pack:
Manufacturer / Distributor:
Sizes:
12V DC
Approx. 30W
Model: RP-8001
INPUT: 100-240V AC / 50/60 Hz
OUTPUT: 12V DC / 4.17 A
RP-8003
OUTPUT: 12V/2.5 Ah
International Biophysics Corporation
2101 E. St. Elmo Rd. Ste. 275
Austin, TX 78744
S (Small - Corresponds to European Size S)
M (Medium - Corresponds to European Size M)
L (Large - Corresponds to European Size XL)

USER INFORMATION
• In the interest of hygiene, please wear the AffloVest over clothing.
• Important: The AffloVest is not intended for use on more than one patient.
• Make sure that the AffloVest fits tightly, with even body contact.
• There is no need to worry if you are disturbed while using your AffloVest. Your vest will
interrupt all set functions after a programmed time and assume a safe standby state.
• In the case of contraindications, it is advisable to consult with your doctor or physician
before wearing the High Frequency Chest Wall Oscillation (HFCWO) AffloVest - especially
in persons with electronic implants, pregnant women and nursing mothers, as well as in all
cases of acute illness, including
• persons with fractures or pain in the upper part of the body
•personswhohavehadrecentsurgicalproceduresonorinjuriestothespinal
column
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.
INDICATIONS FOR USE/METHOD/APPLICATION
INDICATIONS FOR USE
METHOD
The AffloVest generates vibration and oscillation of the user’s chest wall through integral air
compressor modules and channels, 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 in response to
the volume of mucus present in the air pathways per 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: Cystic Fibrosis, COPD, Chronic Bronchitis, and
Pneumonia.

STARTING THE AFFLOVEST IN BATTERY MODE
Attention: The battery must be charged before start-up. See the following section.
USER INFORMATION - RECHARGEABLE BATTERY
• Only use the supplied rechargeable battery (RP-8003) to ensure safe and reliable operation
of the product in battery mode. Only use the supplied charger (RP-8001) to charge the battery.
• The battery must be charged before using the vest for the first time. To charge the battery,
connect it to the supplied charger/power supply unit. The charging time is approximately 3-4
hours. The 4 LED lights on the battery turn green when the battery button is pressed and the
maximum charge has been reached (avoid overcharging).
• When fully charged, the battery has the capacity for 10+ applications of the vest at a
maximum intensity (the battery must be charged when the LED lights no longer light up green).
• When the battery has reached its maximum charge, disconnect it from the charger and
connect it to the AffloVest.
• It is not recommended to start a new cycle if more than half of the LED lights on the battery
are not illuminated, as it cannot be guaranteed that there will be sufficient power to complete
the cycle.
OBSERVE BATTERY WARNING INFORMATION
• Carefully remove the vest from the cardboard box and then take it out of the polyethylene bag.
• Set the buckles to maximum size.
• Put on the vest and fasten all 3 buckles. Firmly pull the straps so that the vest fits snugly on the
body. Adjust the shoulder snaps for comfort, if needed.
• Insert the supplied battery in its pocket in the vest (right-hand side) and connect it to the
connection cable in the vest.
• The flashing LED light on the hand-held controller indicates that the vest is ready for use. All
functions are now available.
• Now select your program - DRAINAGE, VIBRATION, OR PERCUSSION. The vest will start to
work about 1.5 seconds after selecting a program.
• You can now freely choose different PROGRAM and INTENSITY functions.

BATTERY WARNING INFORMATION
• Batteries must never be thrown into a fire or incinerated.
• The cells must not be immersed in liquids, such as water, sea water, or beverages. Contact with
liquids must be avoided.
• Individual cells and batteries are not toys and must be kept away from young children and babies.
• Batteries must not be placed in a microwave or subjected to pressure. They may combust, resulting
in smoke and fire.
• Battery packs must not be subjected to mechanical impact.
• Never dismantle a battery pack, as this may cause internal short-circuits, resulting in gas emissions,
fire and explosion, or other problems.
• The electrolytes and electrolyte vapors contained in lithium polymer batteries are harmful to humans.
Avoid direct contact with electrolytes. If, however, electrolytes come in contact with the skin, eyes, or
other parts of the body, immediately flush or rinse with fresh water and seek medical attention as soon
as possible.
• To avoid total discharge, always switch off the vest after use.
•Always charge batteries in good time, but avoid overcharging.
• Store batteries on a non-combustible, heat resistant, and non-conductive surface.
• Lithium Polymer batteries that are totally discharged are defective and must no longer be used.
• Do not expose the battery pack to direct sunlight.
• The maximum permissible ambient temperature of the battery pack is 122 F degrees.
STARTING IN D/C MODE WITH THE D/C ADAPTER UNIT (RP-8002)
• Connect the supplied adapter lead to the connection cable in the vest.
• Plug the figure-8 power cable of the power supply unit into the socket and into the D/C adapter brick.
• The flashing LED light on the hand-held controller indicates that the vest is ready for use.
• Now, select your program - DRAINAGE, PERCUSSION, OR VIBRATION. The vest will start to work
about 1.5 seconds after selecting the program.
• You can now freely choose the PROGRAM and INTENSITY functions.
TECHNOLOGY AND DESIGN
• The safety aspect was of paramount importance in the design of the product. Consequently, the vest
is equipped with the following safety features:
▬The air compressor modules are operated with safe, low voltages
▬Protective fuse in the event of defective or malfunctioning motors
▬The vest operates on a timer of roughly 8 minutes
▬The vest can be operated from either a battery or wall plug
• A microprocessor control, with which input commands are assigned to the respective function via the
membrane keypad, is at the core of the AffloVest.

BUTTONS AND FUNCTIONS
Press the P2 button to start the VIBRATION program.
All motors operate uniformly at the set intensity level.
Deep oscillation of the thoracic cavity.
Press the P1 button to start the DRAINAGE program.
The individual zones are activated in succession.
Traveling oscillation up and down the thoracic cavity.
After starting the programs, the motors run through a "soft start"
function (approx. 10 seconds) up to the set level of intensity.
Programs P1, P2, and P3 always start with SOFT intensity.
Note: The intensity automatically switches to SOFT when changing the programs P1, P2, and P3.
You can then freely select your chosen intensity levels.
If the program is not changed, the vest will switch off automatically after approx. 8 minutes. After each program
change, the new program continues to run for approx. 8 minutes..
You can stop the application at any time by pressing the STOP button.
Press the P3 button to start the PERCUSSION program.
All motors operate in a pulsating/tapping mode.
Percussion of the upper body with a regular rhythm.
INTENSITY LEVELS

Note: The control will switch to standby mode about 7 minutes after the program has switched off and all
LED lights on the hand-held controller will go out.
All functions are available again after pressing any button.
The LED lights P1, P2, or P3 on the
hand-held controller light up to indicate
the currently active program.
The LED lights 1-5 show which
oscillation zones are currently active.
The OFF LED light indicates:
Constant flashing = AffloVest ready for
operation
Continuous light = Selected oscillation
program active.

TEST REGULATIONS FOR COMMERCIAL/CLINICAL USE
TECHNICAL INSPECTION EVERY 12 MONTHS
Check power consumption at the following setting:
VIBRATION program
Set intensity level to INTENSE: Target value: 30-35 watts
Maximum permissible measured or actual value: 35 watts
SAFETY INFORMATION
The device is certified with the standard EN 60601 and corresponds to the Medical Devices Directive 93/42EEC:
THE MANUFACTURER,HOWEVER,SHALL ACCEPT NO LIABILITY WHATSOEVER FOR ANY DAMAGE AND/OR CONSEQUENTIAL DAMAGE
RESULTING FROM NON-COMPLIANCE WITH THE FOLLOWING SAFETY INFORMATION.
Repairs to electrical devices may only be carried out by IBC authorized electricians or service dealers. Repairs
that aren't carried out professionally can place the user at considerable risk.
The manufacturer shall not be liable for any damage as the result of the product being used for anything other
than its intended purpose, operated incorrectly, or not repaired professionally.
The product may only be used with the power supply unit RP-8001/rechargeable battery RP-8003.
The battery may only be charged with the supplied power supply unit/charger according to the instructions. The
use of any other power supply units and chargers can lead to fire and electric shock. Overcharging must be
avoided.
Pay attention to the voltage ratings on the power supply unit. The device is designed for use with a D/C to A/C
voltage of 100-240V AC, 1..5 A, 50-60 Hz.The ambient temperature range of the power supply unit/charger is
32F - 122F degrees.
The power plug of the power supply unit must always be disconnected from the socket in the event of
malfunctions during operation, before cleaning/upkeep procedures and after use.
Never disconnect the power plug from the socket by pulling the cable or with wet hands.
The power cable must never be pulled over sharp edges or trapped.
Only the supplied power cables are to be used. If damaged, only replace it with the same power cable that is
available from the manufacturer.
The use of any other power cable or charger can lead to fire or electric shock.
Children and disabled persons should not use the vest without supervision.
Do not use the product in damp environments, such as in the bathroom or at a swimming pool.
Do not puncture the product with sharp objects, such as pins and needles.
The connection cables must never be used for the purpose of carrying the product.
Depending on the amount of use, the outer material and cables of the product should be checked for damage
periodically.

GUARANTEE
The AffloVest has a limited lifetime warranty. The battery is guaranteed for 12 months. Every
battery undergoes several tests and inspections during the manufacturing process. We are
committed to ensuring the highest quality standards. The guarantee stipulates that we will
repair, free of charge, proven material defects during the guarantee period. We reserve the right
to replace the battery pack when a repair is not economically feasible. The receipt or bill that
was issued on purchasing the product shall serve as proof for the start and expiration of this
guarantee. Repairs shall not extend the warranty period. Incorrect use or operation, e.g.
incorrect charging or excessively high discharge rates shall invalidate any guarantee claims.
The same applies to defects caused by excessive loads or total discharge. Broader guarantee
claims, e.g. in the event of consequential damage, are ruled out. The liability for damage that is
caused by the battery pack or its use is also ruled out.
Guarantee claims must meet the following prerequisites:
• Enclose the purchase receipt/invoice with the return item.
• The battery pack must have been operated in accordance with these instructions for use.
• The battery pack must have been operated only at the voltage and current ratings specified in
the technical data.
• Include a detailed description of the fault or defect.

ENVIRONMENTAL PROTECTION
This symbol, on products and/or accompanying documents, signifies that electrical
and electronic products must be disposed of separately from any household waste at the
end of their service. To ensure 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 to protect the environment and avoid harmful effects for
human beings and the environment that could arise from incorrect handling of devices at the end
of their service life. You can obtain more detailed information at your nearest collection point for
recyclable materials from your local authority.
Recycling instead of waste disposal: Devices, accessories, and packaging should be recycled
(only for electronic components).
SWITCHING OFF THE AFFLOVEST
• Press the STOP button. All functions are interrupted and the flashing LED light indicates the
standby mode has been engaged.
• Now disconnect the power plug or the battery from the socket.
CLEANING AND CARE
Never immerse the device in water. Use a moist cloth with a neutral detergent to wipe down the vest
(make sure the outer material does not become soaked). Do not rub too hard on the external
labeling. The vest is not washable due to the integrated electronics.
CLEANING AND CARE INFORMATION SYMBOLS
Do Not Wash!
Do Not Iron!
Do Not Bleach!
Do Not Wet Clean!
Do Not Tumble Dry!

TROUBLESHOOTING
A problem may not necessarily be caused by the product. You can save time and money if you
rectify some simple problems yourself. The following section is designed to help you troubleshoot
your vest.
SYMPTOM CAUSE REMEDY
"OFF" LED light does not flash when
vest is ready for operation.
Plug connection of the connection cable and
the power supply unit/battery is not connected
Power plug of power supply unit is not plugged
into socket or battery is not charged/connected
The integrated fuse tripped due to a fault in the
electronic control.
Power supply/unit battery defective
Power supply fuse defective or automatic
circuit breaker tripped
Power Failure
Standby Mode
- Plug in correctly
- Plug in power plug
and/or Plug in/charge battery
- Needs to be repaired by an IBC
authorized electrician or service
dealer
- See above
- Change power supply fuse or
reset automatic circuit breaker
---
- Press any button on the hand-
held controller
The selected program function has
suddenly switched off
The program time set on the timer has elapsed
Battery discharged
- Restart
- Charge battery or switch to
mains mode
Functions can't be set or are not
indicated by the corresponding LED
light
Fault in the electronic control - Needs to be repaired by an IBC
authorized electrician or service
dealer
Vibration units inoperative Motor blocked - Needs to be repaired by an IBC
authorized electrician or service
dealer

ELECTROMAGNETIC GUIDELINES 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.
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 MEASUREMENT CONFORMITY ELECTROMAGNETIC ENVIRONMENT GUIDELINES
RF emissions as per CISPR 11
Harmonic component emissions as per IEC 61000-3-2
Voltage fluctuations/flicker emissions as per IEC
61000-3-2
Class B
Class A
Compliant
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
purposes.
ELECTROMAGNETIC ENVIRONMENT GUIDELINES
INTERFERENCE
IMMUNITY TESTS
IEC 60601-TEST
LEVEL
COMPLIANCE LEVEL
Electrostatic discharge
(ESD) as per IEC
61000-4-2
±6 kV Contact
Discharge
±8 kV Air Discharge
±6 kV Contact
Discharge
±8 kV Air Discharge
Floors should be wood, concrete, or ceramic tile. If floors
are covered with a synthetic 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
Mains power quality should be that of a typical
commerical or hospital environment
Surge Voltages
(Surge) as per IEC
61000-4-5
±1 kV Normal-Mode
Voltage
±2 kV Common-Mode
Voltage
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
40% Ut (60% dip in
Ut) for 5 cyclres
0% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip Ut)
for 5 s
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 (50
Hz) Magnetic Field as
per IEC 61000-4-8
3 A/m Power frequency magnetic fields should be at levels
characteristic of a location in a commercial or hospital
environment
±2 kV for Power
Supply Lines
±1 kV for Input/Output
Lines
±1 kV Normal-Mode
Voltage
±2 kV Common-Mode
Voltage
Mains power quality should be that of a typical
commerical or hospital environment
<5% Ut (>95% dip in
Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cyclres
0% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip Ut)
for 5 s
3 A/m
Note: Ut is the mains AC voltage prior to application of the test level.

ELECTROMAGNETIC ENVIRONMENT GUIDELINESINTERFERENCE
IMMUNITY TESTS
IEC 60601-TEST
LEVEL
COMPLIANCE LEVEL
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=1.2mP
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 surveyashould be less than the compliance
level in each frequency rangeb. Interference may
occur in the vicinity of equipment marked with the
following symbol.
3 Vrms
3 V/m
3 Vrms
150 kHz to
80 MHz
3 V/m
80MHz to
2.5 GHz
Conducted RF
interference as
per IEC 61000-4-6
Radiated RF
interference as
per IEC 61000-4-3
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 absorbtion and reflection
from structures, objects, and persons.
aThe 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.
bThe field strength should be less than 3 V/m over the frequency range from 150 kHz to 80 MHz.
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.

Recommended distances between portable and mobile RF telecommunications equipment and the
AffloVest
The AffloVest is intended for use in an electromagnetic environemnt, 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
W150 kHz to 80 MHz
d=1.2mP
80 MHz to 800 MHz
d=1.2mP
800 MHz to 2.5 GHz
d=2.3mP
0.01
0.1
1
10
100
0.12
1.2
0.38
3.8
12
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
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.