WellAir NOVAERUS Defend 400 User manual

A WellAir Brand
Document No. 70-00001-01-REV-B
COPYRIGHT ©2021 Novaerus
Defend 400 User Manual
Novaerus, Old Finglas Rd.
Glasnevin, Dublin 11
D11 KXN4, Ireland
Phone: + 353 1 907 2750
www.novaerus.com
Novaerus US Inc.
35 Melrose Pl.
Stamford, CT 06902
Phone: + 1 866 508 1118
English | Français canadien | Español

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English. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Français canadien. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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Table of Contents
1. Defend 400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2. Labelling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3. ClassicationofEquipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5. Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
6. TechnicalSpecications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
7. Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
7.1 Moving the Defend 400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
7.2 Powering on the Defend 400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.3 Control Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8. Service and Maintenance Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8.1 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8.2FilterReplacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8.3FilterDisposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.4 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
9. ProductCertications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
11. ElectromagneticCompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
English

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A WellAir Brand

Document No. 70-00001-01-REV-B
COPYRIGHT ©2021 Novaerus
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1. Defend 400
The Defend 400 is a medical device that inactivates aerosolized viruses, bacteria,
and fungi, and puries the air of particulate matter (PM) and volatile organic
compounds (VOCs).
The portable Defend 400 provides airborne infection control in small to medium
sized rooms where risk of hospital-acquired infections (HAIs) and surgical site
infections (SSI) is elevated due to occupancy level, high trafc ow, the type
and duration of procedures carried out, potential infectiousness of occupants,
vulnerability of patient or staff and/or localized environmental conditions.
The intended purpose of the Defend 400 is to improve the quality of air.
This equipment is suitable for use in hospitals and long-term care facilities.
The intended use of the Defend 400 includes intensive care units (ICU), high
dependency units (HDU), and other health institutions, including isolation rooms
and single-patient rooms such as operating rooms (OR).
Please read and follow all the instructions in this manual.
2. Labelling Symbols
Symbol Meaning
Caution
Consult instructions for use
Caution, dangerous voltage
Warning, dangerous voltage
Date of manufacture
Manufacturer

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SN
Serial Number
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
This product conforms to the requirements of the
applicable European Community directives.
Mains Power Switch On (Power)
Mains Power Switch Off (Power)
Indicates the temperature limits to which the medical device
can be safely exposed.
Indicates the range of humidity to which the medical device
can be safely exposed.
This product should not be discarded as unsorted waste but
must be sent to separate collection facilities for recovery
and recycling.
3. ClassicationofEquipment
Item Classication
Ingress Protection IPXX keep dry
Mode of Operation Continuous
Oxygen-rich Environments Not intended for oxygen-rich environments
(e.g. oxygen tents, hyperbaric chambers)

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4. Warnings and Cautions
General Warnings and Cautions
WARNING: This equipment contains high voltage.
WARNING: This High Voltage (HV) device is not suitable for use within
atmospheres that contain potentially combustible or explosive dusts,
vapours, or gases (including oxygen-rich environments, e.g. oxygen
tents, hyperbaric chambers).
WARNING: Do not use outdoors or near water.
WARNING: This device should not be exposed to environmental sterilization
processes such as fogging or misting. Both the water vapour and
chemical agents may cause damage to internal components, thus
invalidating the warranty. The active carbon lter may also absorb the
chemical vapour, thereby minimizing the sterilization effects in the
environment, whilst also reducing the operating life of the lter.
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to mains power with protective earth.
WARNING: To reduce the risk of electric shock, this equipment has a grounding
type plug that has a third (grounding) pin. This plug will only t into a
grounding type power outlet. If the plug does not t into the outlet,
contact qualied personnel to install the proper outlet. Do not alter
the plug in any way.
WARNING: If the power cord is damaged in any way, it must be replaced by a
special cord or assembly available from the manufacturer or its service
agent.
WARNING: This equipment should be inspected frequently and collected dust
removed from it regularly to prevent excessive accumulation that may
result in ashover or a risk of re.
WARNING: No modication of this equipment is allowed.
WARNING: Do not open the tamper proof screws on the casing of the device. No
serviceable parts are contained within.The devices should be opened
by authorised Novaerus personnel only.
WARNING: For continued protection against risk of re, only replace the fuse with
the same type and rating, provided in Section 6, Technical Specications.

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CAUTION: Do not use other lters except those supplied by Novaerus. The use
of other brand or no-brand lters with the Defend 400 will invalidate
the claims that can be made for the performance of the Defend 400.
Novaerus also reserves the right in such situations to refuse warranty
claims.
CAUTION: The device is not meant to be lifted by the handle; wheels are provided
for mobility. While moving the device, lift the power cord off the
ground and away from the wheels. Failure to do so may result in the
power cord impeding the wheels from moving, instability, or damage.
CAUTION: Carefully remove all packaging and shipping tape before use.
CAUTION: Do not restrict the air ow of the product in any way. Make sure the
inlet and outlet are clear of any objects which may restrict airow.
CAUTION: Do not position the equipment where it is difcult to operate the
power switch.
CAUTION: Not to be used by persons (including children) with reduced physical,
sensory, or mental capabilities, or lack of experience and knowledge,
unless they have been given supervision or instruction. Children should
be supervised to ensure that they do not play with this device.
NOTE: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation.This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or
more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV
technician for help.
continued…

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5. Safety Features
TheDefend400incorporatesthefollowingsafetyfeatures:
• Safety interlock switch which will not allow the device to operate if the
rear door is not properly closed.
• Safety interlock switches which will not allow the device to operate if
the lters are not properly inserted.
6. TechnicalSpecications
Model Defend 400
120VAC
Defend 400
220-240VAC
Power
Supply
Nominal Voltage:
Input Voltage Range:
Input Frequency Range:
Power Consumption:
120 VAC
120 VAC
60 Hz
17W – 179W
230 VAC
220 - 240 VAC
50/60 Hz
26W – 188W
Airow
Speed 1:
Speed 2:
Speed 3:
Speed 4:
Speed 5:
7 CFM (12 m3/h )
58 CFM (99 m3/h )
108 CFM (184 m3/h )
166 CFM (283 m3/h )
210 FM (356 m3/h )
43 m3/h (25 CFM)
108 m3/h (63 CFM)
202 m3/h (119 CFM)
305 m3/h (179 CFM)
384 m3/h (226 CFM)
Area Coverage 36 m2| 388 ft2 (4 ACH)
73 m2| 766 ft2 (2 ACH)
39 m2| 420 ft2 (4 ACH)
79 m2| 850 ft2 (2 ACH)
Volume Treated†3,143 ft3| 89 m3 (4 ACH)
6,286 ft3| 178 m3 (2 ACH)
96 m3| 3,390 ft3 (4 ACH)
192 m3| 6,780 ft3 (2 ACH)
Fuse Dual 5 A, 250 VAC, Anti-Surge, 5 × 20 mm
Dimensions 15.0" (w) × 15.0" (d) × 33.7" (h) 380 mm (w) x 380 mm (d) x 855 mm (h)
Weight‡56.7 lbs 25.7kg
Filters
Stage 1 Pre Filter:
Stage 2 HEPA Filter:
Stage 3 Carbon Filter:
M5 EN 779, ePM10 65% ISO 16890
H13 EN 1822
G4 EN 779, Coarse 65% ISO 16890
Noise
Speed 1:
Speed 2:
Speed 3:
Speed 4:
Speed 5:
44.3 dBA
51.5 dBA
61.0 dBA
67.0 dBA
70.2 dBA
42.3 dBA
54.6 dBA
63.3 dBA
69.6 dBA
72.9 dBA
* ACH = Air changes per hour
† Room with 2.44 m (8 ft) high ceiling
‡ Weight includes lters

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Model Defend 400
120 VAC
Defend 400
220-240VAC
Operating
Conditions
Temperature:
Relative Humidity:
50 - 95 °F
10 - 75 %
10 - 35 °C
10 - 75 %
Storage/
Shipping
Conditions
Temperature:
Relative Humidity:
41 - 122 °F
Max 95 %
5 - 50 °C
Max 95 %
MountingType Floor standing
Portability Movable (2-wheeled base & handle)
Construction & Colour Grey moulded plastics, white aluminum composite, and precision-cut stainless steel with anti-microbial
powder coat nishes.
Quality
& Safety Manufactured Under: ISO 9001
ExpectedServiceLife 5 years
continued…

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7. Instructions for Use
7.1 Moving the Defend 400
Position yourself close to the back of the device holding the handle rmly with
both hands. Pull the handle slowly towards your body while stepping back onto
your other foot as illustrated in Figure 1 below.
Stabilize the Defend 400 at a comfortable angle, depending on your individual
height, where minimal pressure is exerted against your body to ensure stability
and either push or pull it to a desired location.
Care should be taken when moving the Defend 400 to a desired location. Take
extracarewhenmovingthedeviceupordownstepsoroverhumps.Always
lowerthedevicedowncarefully,neverlettingitdropunderitsownweight.
Figure 1 – Moving the Defend 400
Once you have reached your destination, allow the device to gently return to the
upright position by placing one foot against the base and gently extending your
forearms allowing the device to return to the front legs to stabilize the device.
The Defend 400 should be placed in a dry location and connected to a suitable
grounded outlet. The product is intended to be used as a oor standing unit only.
When selecting a location for the device, allow for enough space around the sides
and front to ensure free airow.
Once the device is installed at the desired location it can be powered ON.

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7.2 Powering on the Defend 400
BeforeturningONthedevice,ensurethatthepowersupplymatchesthedevice's
ratedpowersupplyasmarkedontheproductlabelabovethepowerinlet.
The Defend 400 is powered using mains power supply as described in Section 6,
Technical Specications. The device should be connected to the electric outlet
using the power cable provided. Ensure the cable is properly connected to the
mains power socket and to the device’s power inlet which can be found near
the wheels on the rear side of the device. Once the cable has been connected,
turn ON the mains power switch followed by the device’s power switch which is
located beside the power inlet. Once powered, the device’s display will turn ON
and show the control interface, which is described in Section 7.3 below.
Ensureallpackagingisremovedfromthedeviceandfromtheltersbefore
poweringONthedevice.
Ensureallltersaresecureinplaceandthedoorclosedshutbeforepowering
ON the device.
Figure 2 - Location of power inlet
Your power cable may have a built-in mechanical retaining system to prevent
unexpected disconnections. To release the cable from the device, press down
on the small button located on the connector housing (shown in gure 3 below)
while simultaneously pulling outward.
Figure 3

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7.3 Control Interface
The Defend 400 can be controlled using touch screen interface on the top of
the device. Figure 3 below provides a labelled layout of the interface along with a
description of each of the elements below that.
5 6 7
3
24
1
2
3
4 5
6
7
Figure 4 – Defend 400 Control Interface
7.3.1 Power Control
The device can be switched ON and OFF using the power button [1] on the
left-hand side of the control interface. The power state indicator [2] will be
illuminated blue when the device is powered ON and grey when powered OFF.
7.3.2AirowControl
The airow of the device can be controlled using the increase airow button [5]
on the right-hand side, and the reduce airow button [3] on the left-hand side.
The current airow setting is indicated in the centre by the airow speed
indicator [4], as series of 5 dots which light up from left to right as airow speed
is increased.
7.3.3SaveAirowtoMemory
The current speed setting can be saved to memory using the save speed button
[7]. In the case of a power failure, the device will power back ON directly to the
saved speed. The blue indicator on the save speed button [6] will be illuminated
when a speed is saved. To clear a saved speed, use the clear saved speed button
[7]. The indicator for saved speed will turn off when the saved speed is cleared.
1. Power button.
2. Power state indicator.
3. Reduce airow speed button.
4. Airow speed indicator.
5. Increase airow speed button.
6. Indicator for save speed setting.
7. Save/clear saved speed button.

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7.3.4DisplaySleepMode
To prevent disturbances and save power, the control display will go into sleep
mode after one minute of inactivity. The display can be woken up by touching
the display.
8. Service and Maintenance Instructions
8.1 Service
No serviceable parts are contained within the Defend 400 device. The devices
should be opened by authorised Novaerus personnel only. It is designed with
tamper-proof screws to ensure that it cannot be easily opened by anyone other
than service personnel.
8.2FilterReplacement
Beforereplacingltersensurethepowerisswitchedoffattherearmainsswitch.
Ensureallltersaresecureinplaceandthedoorclosedshutbeforeswitchingthe
device back on via the rear mains switch.
OnlyoriginalNovaerusbrandedltersshouldbeused.Usingnon-certiedlters
couldaffectthesafetyandperformanceoftheDefend400andshouldnotbe
used under any circumstances.
1
2
3
Figure 5 - Defend 400 Filters: [1] Pre-Filter, [2] HEPA Filter, [3] Carbon Filter.

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The lters of the Defend 400 can be accessed by opening the rear door as
shown in Figure 4 above. For safety reasons, the device will not function if the
door is not closed properly or if any of the lters are not inserted properly.
8.2.1 Pre-Filter
The intake Pre-Filter is located at the very bottom of the device. It is labelled
Filter 1, and coloured aqua blue (see Figure 4).
This lter should be inspected monthly and should be replaced when dirty. It is
recommended to replace this lter after three (3) months of continuous use.
It is recommended that the user inspect the intake Pre-Filter monthly during
the rst 2 months of use to determine the most appropriate cleaning period. If
enough dust and debris has collected on the lter to cause signicant decrease in
airow, more frequent replacement of this lter may be required.
The Pre-Filter can be removed by simply pulling outward on the lter’s frame
and replacing it with a new lter. Ensure that the lter’s label is outward facing
and oriented correctly with the arrows pointed upward. Ensure that the lter is
pushed all the way in.
Figure 6 – Pre-Filter Label
8.2.2HEPAFilter
The HEPA Filter is located above the core of the device just below the Carbon
Filter. It is labelled Filter 2 and coloured orange (see Figure 4).
The HEPA Filter should be replaced after twelve (12) months of continuous use.
Discolouration on the lter may indicate that it has exceeded its life expectancy.
The expected lifetime of these lters is approximately twelve months (12) under
normal clean air conditions (such as that of a hospital ward).

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To remove the HEPA Filter, rst release the Filter Lock by pulling it upward.
Next, remove the Carbon. Finally, the HEPA Filter can be removed. The HEPA
Filter has a handle which can be used to pull the lter out of the device. When
inserting a lter, ensure the lter's label is facing outward and oriented correctly
with the arrows pointed upward. Ensure that the lter is pushed all the way in.
Figure 7 - HEPA Filter Label
8.2.3 Carbon Filter
The Carbon Filter is located above the HEPA Filter. It is labelled Filter 3 and
coloured charcoal (see Figure 4).
The Carbon Filter should be replaced after four (4) months of continuous use.
The expected lifetime of these lters is approximately four (4) months under
normal clean air conditions (such as that of a hospital ward).
To remove the Carbon Filter, rst release the Filter Lock by pulling it upward.
The Carbon Filter will then be free to be removed. The Carbon Filter has a
handle which can be used to pull the lter out of the device. When inserting a
lter, ensure the lter's label is facing outward and oriented correctly with the
arrows pointed upward. Ensure that the lter is pushed all the way in.
Figure 8 - Carbon Filter Label

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8.3FilterDisposal
Thefollowinginstructionsareforlterdisposalforltersusedinnon-hazardous
environments.
Filter Disposal
Pre-Filter Throw-away, dry type air lter
HEPA Filter Throw-away, dry type air lter
Carbon Filter Throw-away, dry type air lter
Followthebelowinstructionstoproperlydisposeofausednon-hazardous
airlter:
1. Before beginning, have a plastic bag available.
2. Turn off the device.
3. Carefully remove the used air lter from the device.
4. Place it gently into the bag without shaking it. This will prevent it from
releasing the dust and particles into the air.
5. Tie or tape the bag shut.
6. Take the bagged air lter and place it in the correct waste disposal
stream.
Forltersusedinenvironmentallyhazardousand/orbiomedicalhazardousair
streamsfollowtheoccupationalsafetyandhealthadministrationguidelinesinthe
country of origin.
8.4 Cleaning
The Defend 400 should be visually inspected on a monthly basis for accumulation
of dust on the vent grills that are located at the top and bottom. It is
recommended that the device be cleaned using a vacuum cleaning brush from the
outside to remove any dust that may have accumulated on the grills.
Cleanthebodyofthedeviceregularlytopreventdustfromcollecting.
1. Wipe away dust with a soft dry cloth from the body of the Device.
2. Clean the air outlet with a soft dry cloth.

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9. ProductCertications
10. Troubleshooting
Ifyouareexperiencingaproblemwithyourdevice,pleasecheckthefollowingpoints:
Symptom Solution
No power to the device.
1. Check that there is power at the electric
outlet.
2. Check that the power cable is properly
connected to the device.
3. Check that the power switch located besides
the power inlet is switched ON.
4. Check that no fuses have blown.
The display is ON and
front LED ring is ON but
fan does not turn ON.
1. Check that the on-screen power button is
turned ON.
2. Check that all three lters have been
properly inserted.
3. Check that the lter lock is down.
4. Check that the door is closed properly.
If none of the above solutions restore normal operation, contact a representative
of the Novaerus technical team for assistance.
Should the device sustain severe damage and/or an increase in noise from the
internalpartsisobserved,discontinueuse,andcontactarepresentativeofthe
Novaerustechnicalteamforassistance.Thisproductisnotintendedtobe
repairedintheeld.
Do notattempttorepairthedeviceyourselfsincethismaycauseinjuryand/or
void the warranty.
Defend 400 (120 VAC)
EN IEC 60601-1:2006/A1:2013,
EN IEC 60601-1-2:2014
FDA K200321.510(k) Class II
Medical Device
Defend 400 (220 - 240 VAC)
CE Mark, Low Voltage Directive (LVD)
2014/35/EU, Electromagnetic Compatibility
(EMC) 2014/30/EU,
EN IEC 60601-1:2006/A1:2013,
EN IEC 60601-1-2:2014
EN 60335-1:2012/A13:2017,
EN 60335-2-65:2003/A11:2008