Flight Dental Systems DEFENDME User manual

Flight DEFENDME Aerosol Evacuator R.1.2
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DEFENDME AEROSOL EVAUCATOR
USER MANUAL

Flight DEFENDME Aerosol Evacuator R.1.2
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Table of Contents
1.0 Scope of DefendMe Aerosol Evacuator........................................................................... 3
2.0 Symbols .......................................................................................................................... 4
3.0 Introduction ..................................................................................................................... 5
3.1 Device Description............................................................................................................ 5
3.2 Safety Instructions............................................................................................................ 5
4.0 Installation....................................................................................................................... 6
4.1 Removing the Protective Foam......................................................................................... 6
4.2 Installing DefendMe Aerosol Evacuator............................................................................ 7
5.0 User Interface.................................................................................................................. 8
6.0 Operating Instructions ..................................................................................................... 9
6.1 Air Volume Setting............................................................................................................ 9
6.2 Connect the Speed Controller for Air Volume Adjustment................................................. 9
6.3 Power Off ......................................................................................................................... 9
7.0 Maintenance...................................................................................................................10
7.1 Cleaning and Disinfection................................................................................................10
7.1.1 Cleaning....................................................................................................................10
7.1.2 General Recommendations.......................................................................................11
7.2 Filter Replacement ..........................................................................................................11
7.2.1 Frequency of Filter Replacement ..............................................................................11
7.2.2 How to Replace Filters..............................................................................................12
8.0 Troubleshooting..............................................................................................................12
9.0 Technical Data ...............................................................................................................13
10.0 EMC Tables ...................................................................................................................14

Flight DEFENDME Aerosol Evacuator R.1.2
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1.0 Scope of DefendMe Aerosol Evacuator
1. Main Enclosure
2. Directional Duct
3. Suction Nozzle
4. Speed Controller
5. Power Cord

Flight DEFENDME Aerosol Evacuator R.1.2
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2.0 Symbols
WARNING If the instructions are not followed properly, operation of this device
may lead to hazards for the user/patient and failure of the equipment
NOTE Additional information: Explanation of operation and performance.
Serial number
Catalogue number
Date of Manufacturing
LOT Lot Number
Protective earth (ground)
Type B applied part
Fuse
WEEE directive marking
Keep dry
Temperature Range
Humidity Range
Atmospheric pressure Range
Manufacturer’s LOGO
CE Marking
E C REP
Authorized Representative in the European Community
Consult instructions for use

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3.0 Introduction
3.1 Device Description
The Flight DefendMe Aerosol Evacuator is used to reduce aerosols created by the use of
handpieces, scalers, prophy abrasion, abrasion powder, mercury vapour and any other device
that creates aerosols during a dental procedure. The device must only be used in hospital
environments, clinics or dental offices by qualified dental personnel.
3.2 Safety Instructions
1. Please read the manual before use.
2. The DEFENDME system must be placed upright while being used. Laying the unit on its
side or upside down is prohibited, doing so will cause damage to the machine and
shorten its service life.
3. After replacing the filter or after opening the main enclosure, please ensure that the
rubber gasket/seal is flat or the device will leak and the suction power will be reduced.
4. When closing the lid of the main enclosure make sure to press the top cover down firmly
and then fix the latch or the latch may become damaged.
5. The main filter is heavy, be careful when replacing it. The DEFENDME Aerosol
Evaucator is heavy, so be careful when moving it.
6. When replacing the primary filter, it should be noted that the dense side faces the filter
and the sparse side faces the air inlet.
1. The device can capture airborne bacteria and viruses in aerosols created during
dental procedures. The device will vacuum aerosols into the system and filter
and disinfect any viruses or bacteria. Please note that the device cannot be
used to prevent the spread of viruses and bacteria in the air that is not filtered
through the device.
2. The device must not be placed in a humid environment or anywhere where it
can come into contact with any type of liquids.
3. Do not expose the device to direct or indirect heat sources. The device must be
operated and stored in safe environment.
4. The device requires special precautions with regard to electromagnetic
compatibility (EMC) and must be installed and operated in strict compliance
with the EMC information. In particular, do not use the device in the vicinity of
fluorescent lamps, radio transmitters, remote controls and do not use this
system near active HF Surgical Equipment in the hospital. Portable RF
communications equipment (Including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 Inches) to any part
of the DEFENDME Aerosol Evacuator or the performance of the device will be
affected.
5. Do not operate or store in high temperatures. Please comply with the specified
operating and storage conditions.
6. If irregularities occur in the device during treatment, switch it off, contact an
authorized representative/distributor.
7. Device should only be serviced by an authorized representative or the warranty
will be void.

Flight DEFENDME Aerosol Evacuator R.1.2
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4.0 Installation
4.1 Removing the Protective Foam
Before using the machine for the first time, please remove the foam at the bottom of the main
filter assembly otherwise the machine will not work properly. Please refer to the following steps
to remove the foam.
Step
Diagram
Description
1
Removing Top Cover:
Remove the top cover by undoing the 4
latches marked by the blue arrows and
remove the top cover.
2
Remove the main filter assembly:
Remove the rubber gasket/seal and filter
elements in sequence. Then take out the
main filter assembly circled in the
diagram.
3
Remove the foam:
Remove the foam installed at the bottom
of the main filter element. The foam can
be discarded accordingly.
4
Reassembling the Unit:
Reinstall all the filters in the same order
that they were removed and secure the
four latches to the top cover. Ensure that
the gasket is flat and that the top cover is
secured before using.

Flight DEFENDME Aerosol Evacuator R.1.2
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4.2 Installing DefendMe Aerosol Evacuator
Step
Diagram
Description
1
Installation of the Suction Nozzle:
Fasten the suction nozzle to the
directional duct by screwing the nut onto
the duct
2
Installation of the Directional Duct:
Plug the direction duct to the top of the
cover.
Directional duct should be installed
vertically and perfectly secured or the
suction power will be reduced.
3
Connecting power cord:
Connect the power cord to the main
enclosure and plug into a 110/220V outlet.
Only the original power cord should be
Used.

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4
Connect the Speed Controller:
Plug the connector of the speed controller
into the main housing as shown in the
picture.
5.0 User Interface
1. Screen Display
2. Speed Increase
3. Speed Decrease
4. Power Switch
Turn power On
Press Power Switch to “ “ to turn on.
Speed Increase
Press speed up key to change air volume from
1 to 10.
Speed Decrease
Press the Speed Down key to change air
volume from 10 to 1.
Turn Power Off
Press Power switch to “ “ to turn off.

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5. Speed Setting Knob
6. Speed Controller Power Switch
Turn on the Controller:
Press speed Controller power switch to “ON”
Speed Setting:
Rotate Speed Setting knob clockwise to
increase air volume from 1 to 10 and counter
clockwise to reduce the speed.
Turn of the Controller:
Press the Speed Controller power switch to
“OFF”
6.0 Operating Instructions
6.1 Air Volume Setting
A speed of 1-10 can be set for the air volume. Click the up button or down button to set the air
volume accordingly. 1 is the lowest air speed and 10 is the highest air speed.
6.2 Connect the Speed Controller for Air Volume Adjustment
When the air volume controller is connected, the up arrow or the down arrow on the machine
fails, and the air volume can only be adjusted by the knob on the controller. When the air
volume is large, the suction capacity of the machines is strong. It is recommended to work
under the condition of larger air volume.
6.3 Power Off
Turn off the device by pressing the volume controller power switch to “OFF” and the window will
Do not block the air inlet to avoid damage to the motor. After the filter is blocked please replace the
filter immediately to avoid damage to the motor.
•Before using the device for the first time, be sure to remove the foam placed under the main
filter.
•When using the latch, be sure to press the top cover down firmly to avoid damaging the
latch.
•Fix the Directional air duct by adjusting the direction of the air duct according to the
individuals needs.
•Make sure that the power supply is connected and the power switch is turned on. When the
controller is not plugged in the value displayed on the screen is the previous setting prior to
being turned off.
•When the unit turns on, the display will show a number between 1 to 10. If the device does
not turn on within 3 minutes, the total flow value will be displayed. The flow value is a three-
digit value, the cumulative value is 001 when the fan rotates 5.76 million revolutions.

Flight DEFENDME Aerosol Evacuator R.1.2
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display “OFF”. To disconnect the power supply please press the power switch on the main
enclosure box.
7.0 Maintenance
7.1 Cleaning and Disinfection
7.1.1 Cleaning
For hygiene and safety purposes, the suction nozzle must be cleaned and disinfected before
each use to prevent any cross-contamination. The components directional duct, main enclosure,
power cord and speed controller should be cleaned and disinfected regularly according to the
frequency of use. Comply with your local regulations for cleaning and disinfection.
The device should no longer be used if there are signs of damage to the device or any its
Condensation may appear on the suction nozzle if the temperature of the
suction nozzle is much lower than the atmospheric temperature. If this occurs,
run the device for 15-30 minutes continuously without suctioning any aerosols
to make sure there is no water vapour in the directional duct and suction nozzle
before continuing to use.
Components:
1. Main Enclosure
2. Main Filter Assembly
3. Secondary Filter Assembly
4. Primary Microfiber Filter
5. Rubber Gasket/Seal
6. Top Cover
7. Directional Duct
8. Suction Nozzle

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components. Please contact your authorized dealer for repair or replacement of any
components.
7.1.2 General Recommendations
•The user is responsible for disinfecting the product before use.
•For you own safety, please wear the appropriate personal protective equipment (PPE)
(gloves, safety glasses, gowns etc) when using and cleaning this device.
•Use only the correct disinfection solutions or wipes as approved by your local regulators
(FDA, Health Canada) and in accordance with the IFU of the manufacturer
•For cleaning of the components please use distilled water only.
•Do not use bleach or chloride disinfectant materials.
Components to Disinfect
Suction Nozzle
Directional Duct
Main Enclosure
Power Cord
Speed Controller
Wipe all the surfaces with a cloth or wipe with at least 70-80% ethanol or an approved
disinfectant. Wait at least 2 minutes and repeat 5 times. Or follow the recommendations of the
disinfectant manufacturer.
Do not spray excessive ethanol or disinfection solution as it may go into the system and
damage the components inside.
7.2 Filter Replacement
7.2.1 Frequency of Filter Replacement
Components
Frequency
Durability
Flow Value (Usage)
Primary Microfiber Filter 1-3 months Display 010 or a multiple of it
Eg. 010/020/030.

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Secondary Filter Assembly 3-6 months Displays 050 or a multiple of
it.
Eg.050/100/150
Main Filter Assembly 12 Months Display 100 or a multiple of it
Eg. 100/200/300
Replace relevant filter according to the duration (months) or if the flow value has
been reached. Or when the LED display shows a circle than the filter must be replaced.
The flow value is a three-digit value; the cumulative value is 001 when the fan rotates 5.76
million revolutions.
7.2.2 How to Replace Filters
Release the four latches on the upper cover of the machine and remove the top cover. Inside
you will see the primary microfiber filter, secondary filter assembly and main filter in that order.
Replace each filter accordingly. When replacing the main filter ensure that the filter is placed
correctly and that the plug for the fan is connected to the bottom of the filter.
8.0 Troubleshooting
If the device malfunctions please follow the table below before contacting your dealer to resolve
the issue. If the problem persists please contact your local authorized distributor or dealer.
Problem
Reason
Solution
The display flashes “OFF” and
a circle rotates clockwise on
the display or the alarm goes
off and the fan stops working
The air inlet is completely
blocked.
Turn off the power and check
the directional air duct and
suction nozzle to see if there
is a blockage. Remove any
blockages.
If the problem persists, open
up the upper cover and check
When replacing the filter ensure that the power is turned off and the unit is unplugged.

Flight DEFENDME Aerosol Evacuator R.1.2
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if there is a blockage between
the directional duct and the
top cover preventing air from
going into the main enclosure.
After these steps, restart the
machine and observe for one
minute if the alarm still comes
on. If it does than replace the
filters.
LED Display has “ERR” alarm,
and the fan and motor has
stopped working
The fan has malfunctioned or
the connection to the fan has
a problem.
Turn off the power and restart
the machine to check whether
the fan is working properly, if
not check the fan and the
connections to the fan to
ensure they are all secure.
9.0 Technical Data
Manufacturer
HR Dental Products Inc. o/a Flight Dental Systems
Model
DefendMe Aerosol Evacuator
Model #
AE-1000
Dimensions
16 x 9 x 18” (L x W x H)
Duct
Diameter 3 inch x 59 inch Length (D75 x 1500L)
Weight
46 lbs (21kg)
Input
100-120V/60hz
Power
250W Max
Filter Efficiency (0.3um)
99.97%
Static Pressure
3000pa
Air Rate
14 m/s
Volume (Filter Included)
3.7m3/ min
Ultraviolet
Ultraviolet lamp intensity: 2260uW/cm3,
Wavelength: 265-285nm
Electrical Safety Class
Class I
Applied Part
B
Operating Conditions
Use: In Enclosed Spaces
Ambient Temperature: 5C to 40C
Relative Humidity: <80%
Operating Altitude <3000m above sea level
Transport and Storage
Conditions
Ambient Temperature: -20C to +55C
Relative Humidity: 20% to 80%
Atmospheric Pressure: 70kPa to 106kPa

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10.0 EMC Tables
Guidance and manufacturer’s declaration – electromagnetic emissions
The DEFENDME is intended for use in the electromagnetic environment specified below. The customer or the user of the DEFENDME
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions CISPR 11 Group 1
The DEFENDME uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions CISPR 11
Class B
The DEFENDME is
suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic emissions
The DEFENDME is intended for use in the electromagnetic environment specified below. The customer or the user of the DEFENDME
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions CISPR 11 Group 1
The DEFENDME uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions CISPR 11
Class B
The DEFENDME
is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies
buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
Electrostatic discharge (ESD) IEC
61000-4-2 +/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/-
8 kV,
+/- 15 kV air
+/- 8 kV
contact
+/- 2 kV, +/- 4 kV, +/-
8 kV,
+/- 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should
be at least 30 %.
Electrical fast transients/bursts
IEC 61000-4-4 ±2kV
100kHz
repetition
frequency
±2kV
100kHz
repetition
frequency
Mains power quality should be that of
a typical commercial or
hospital environment.

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Surge
IEC 61000-4-5 Line to line: ±0.5kV, ±1kV
Line to earth:
±0.5kV, ±1kV,
±2kV
Line to line:
±0.5kV, ±1kV
Line to earth:
±0.5kV, ±1kV,
±2kV
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips IEC 61000-4-11
Voltage interruptions IEC 61000-4-
11
0% UT; 0.5
cycle
at 0°, 45°, 90°,
135°, 180°,
225°, 270°,
and 315°
0% UT; 1
cycle and 70% UT;
25/30
cycles
sine phase at 0°
0% UT;
250/300 cycle
0% UT; 0.5
cycle
at 0°, 45°,
90°, 135°,
180°, 225°,
270°, and
315°
0% UT; 1
cycle and 70%
UT;
25/30 cycles sine
phase at 0°
0% UT;
250/300 cycle
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of devices
require continued operation during
power mains interruptions, it is
recommended that devices be powered
form an uninterruptible power supply or
a battery
Electrostatic discharge (ESD) IEC
61000-4-2 +/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8
kV,
+/- 15 kV air
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/-
8 kV,
+/- 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should
be at least 30 %.
Electrical fast transients/bursts
IEC 61000-4-4 ±2kV
100kHz
repetition
frequency
±2kV
100kHz
repetition
frequency
Mains power quality should be that
of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5 Line to line: ±0.5kV, ±1kV
Line to earth:
±0.5kV, ±1kV,
±2kV
Line to line:
±0.5kV, ±1kV
Line to earth:
±0.5kV, ±1kV,
±2kV
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips IEC 61000-4-11 0% UT; 0.5
cycle
at 0°, 45°, 90°,
135°, 180°,
225°, 270°,
and 315°
0% UT; 1
cycle and 70% UT;
25/30
cycles
sine phase at 0°
0% UT; 0.5
cycle
at 0°, 45°,
90°, 135°,
180°, 225°,
270°, and
315°
0% UT; 1
cycle and 70%
UT;
25/30 cycles sine
phase at 0°
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of devices
require continued operation during
power mains interruptions, it is
recommended that devices be
powered form an uninterruptible
power supply or a battery

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Voltage interruptions IEC 61000-4-
11
0% UT;
250/300 cycle
0% UT;
250/300 cycle
Rated Power frequency magnetic field
IEC 61000- 4-8 30 A/m 50Hz or 60Hz 30 A/m 50Hz or 60Hz Power frequency magnetic field should be at levels characteristic of a typical
location in a typical
commercial or hospital environment.
Note: UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at
60Hz
Guidance and manufacturer’s declaration – electromagnetic immunity
The DEFENDME is intended for use in the electromagnetic environment specified below. The customer or the user of the DEFENDME
should assure that it is used in such an
environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Conducted dis-turbances induced by
RF fields
IEC 61000-4-6
3 V
0.15 MHz – 80 MHz, 6 V
in ISM bands be- tween
0.15 MHz and 80 MHz,
80 % AM at 1 kHz
3 V/m, 80 MHz
– 2,7 GHz,
80 % AM at 1
kHz
3 V Portable and mobile RF communications
equipment should be used no closer to
any part of the DEFENDME, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended minimum
separation distances
See the RF wireless communication
equipment
Radiated RF EM fields IEC 61000-4-
3
3V/m
table in "Recommended
minimum separation
distances"
Proximity fields from RF
See the RF
Complies
wireless communication
wireless
equipment
communication
IEC 61000-4-3
equipment table
in
"Recommended
minimum
separation
distances"

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Recommended minimum separation distances
Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are
used. When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety
and essential performance may be affected. The DEFENDME has been tested with the immunity test level in the below table and meet the
related requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless
communications
equipment and the DEFENDME as recommended below.
Test
frequency (MHz) Band
(MHz)
Service Modulation
Maximum
power (W) Distance
(m)
Immunity
test level (V/m)
385 380-390 TETRA 400
Pulse
modulation 18Hz
1.8 0.3 27
450 430-470 GMRS 460
FRS 460
FM
± 5 kHz deviation 1 kHz
sine
2 0.3 28
710
704-787 LTE Band 13, 17
Pulse modulation 217Hz
0.2 0.3 9
745
780
810
800-960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse modulation 18Hz
2 0.3 28
870
930