NOVAERUS Defend 1050 User manual

Document No. NOV-MNL-103

Novaerus, US Inc.

35 Melrose Pl.

Stamford, CT 06902

Phone: 1.866.515.5181

www.novaerus.com

Defend 1050 User Manual

(NV1050)

FDA Cleared

510(k) Class II Medical Device

Table of Contents

1. Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3. ClassicationofEquipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

4. Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

5. TechnicalSpecications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

6. Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

7. Service and Maintenance Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

8. Filter Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

9. Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

11. ProductCertications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

12.APPENDIXA.GuidanceandManufacturer’sDeclarations . . . . . . . . . . . . . 15

Document No. NOV-MNL-103

1. Intended Purpose

The Novaerus Defend 1050 (NV1050) is a free-standing, portable recirculating

air cleaning system designed for additional frontline protection in healthcare

settings such as operating rooms, intensive care units, in vitro fertilization labs,

emergency rooms, waiting and treatment areas, neonatal units, and other critical

environments including those performing aerosol-generating medical procedures

(AGMP).

Please read and follow all instructions in this manual.

2. Labeling Symbols

Symbol Meaning

Caution, Consult User’s Manual

Caution, High Voltage

Date of Manufacture

Manufactured for or by

Serial Number

This product has been tested by UL to nationally recognized

safety and sustainability standards.

Mains Power Switch On (Power)

Mains Power Switch Off (Power)

Accompanying documents must be consulted

Document No. NOV-MNL-103

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.

3. ClassicationofEquipment

Item Classication

Protection of Harmful Ingress of Water IPX0 (No protection, indoor use only)

Mode of Operation Continuous

Oxygen Rich Environments Not intended for oxygen rich

environments

4. Warnings

GeneralWarnings

CAUTION: This High Voltage (HV) Device is not suitable for use within

atmospheres that contain potentially combustible or explosive dusts,

vapors or gases (including oxygen rich environments).

CAUTION: This device should not be exposed to environmental sterilization

processes such as fogging and misting. Both the water vapor and

chemical agents may cause internal damage to device componentry

thus invalidating the warranty. The active carbon lter may also absorb

the chemical vapor, thereby minimizing the sterilization effects in the

environment, whilst also reducing the operating life of the lter.

CAUTION: The product is not meant to be carried or lifted by the handle.

Castors are provided for mobility, risk of instability if power cord stops

wheels from moving, ensure cord is lifted above the wheels.

CAUTION: Use two or more people to move and handle this unit. Failure to do

so can result in back or other injury. Carefully remove the packaging

materials and any shipping tape before using.

CAUTION: This equipment contains high voltage

Document No. NOV-MNL-103

CAUTION: To avoid the risk of electric shock, this equipment must only be

connected to a supply mains with protective earth.

CAUTION: This equipment should be inspected frequently and collected dirt

removed from it regularly to prevent excessive accumulation that may

result in ashover or a risk of re.

CAUTION: No modication of this equipment is allowed.

CAUTION: Do not modify this equipment without authorization of the

manufacturer.

CAUTION: Do not restrict the air ow of the product.

CAUTION: Do not open the tamper proof screws on the casing of the unit. No

serviceable parts are contained within.The units should be opened by

qualied Novaerus personnel only.

CAUTION: Do not use other lters except those supplied by Novaerus. The use

of other brand or no-brand lters with the NV1050 will invalidate

the claims that can be made for the performance of the NV1050.

Novaerus also reserves the right in such situations to refuse warranty

claims.

CAUTION: Do not position the equipment where it is difcult to operate the

power switch.

CAUTION: For continued protection against risk of re, replace the fuse with the

same type and rating, Fuse rated at 120 VAC, 6.3 Amps.

CAUTION: Do not use outdoors or near water.

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 the appliance.

CAUTION: 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.

CAUTION: 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.

CAUTION: Please remove plastic packaging from lters before use.

Document No. NOV-MNL-103

5. TechnicalSpecications

Floor standing, 2-wheeled base +

handle, 5 speed fan setting with 6.6 ft

power cord

Area Coverage:

200 – 1,000 ft2( 4 air changes per

hour)

400 – 2,000 ft2(2 air changes per hour)

Volume Treated:

1,600 – 8,000 ft3(4 air changes per

hour)

3,200 – 16,000 ft3(2 air changes per

hour)

ElectricalRating:

Single phase, 100-120 VAC, 60 Hz

Fuse rated at 120 VAC, 6.3 Amps,

Listed

Power Consumption:

Maximum 396W

Construction + Color:

Precision-cut fabricated metal casing

in a white anti-bacterial powder coat

nish.

Dimensions:

36.2” (h) × 19.3” (w) × 23.2” (d)

Weight

Approx. 118.6 lbs

ElectricalConnection:

Switched and fused with a grounded,

molded and detachable power cord.

FanAirowVolume:

Speed 1 = 107 CFM

Speed 2 = 187 CFM

Speed 3 = 267 CFM

Speed 4 = 400 CFM

Speed 5 = 553 CFM

NoiseLevel:

Speed 1 = 48 dBA

Speed 2 = 56 dBA

Speed 3 = 62 dBA

Speed 4 = 70 dBA

Speed 5 = 78 dBA

Filters:

Stage 1: M5 30/30 lter

Stage 2: HEPA H13 lter, MGA grade

Stage 3: G4 carbon pleated lter

Operating Conditions

50 – 95 °F, 10 - 75% Relative Humidity

Shipping / Storage Conditions

41 – 122 °F, Maximum 95% Relative

Humidity

Quality + Safety:

Manufactured under ISO 9001, ISO

14001 & OHSAS 18001.

IEC 60601-1,Third Edition

IEC 60601-1-2, Fourth Edition

UL 867 Safety for Electrostatic Air

Cleaners

FDA K200321.510(k) Class II Medical

Device

Document No. NOV-MNL-103

6. Instructions for Use

a. Transporting the Defend 1050

When transporting the Defend 1050, care should be taken when moving the unit

to the desired location.

The transporter should be positioned close to the back of the unit holding the

transport handle rmly with both hands. The transporter should place one foot

against the base of the Defend 1050 for anchorage and pull the handle slowly

towards them, stepping back on to their other foot.

Stabilize the Defend 1050 at a comfortable angle, depending on the transporters

individual height, where minimal pressure is exerted against the body to ensure

stability.

Once the destination has been reached, allow the unit to gently return to the

upright position. The transporter should place one foot against the base of the

unit and gently extend their forearms, allowing the unit to rest on its front feet.

The Defend 1050 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.

Once the product is installed, turn the power switch on the back of the unit to

the ON position. The device is now ready to operate, please use the control

panel to activate the unit to the desired speed.

Document No. NOV-MNL-103

Control Panel and Location

The control is located on the top panel of the Defend 1050 near the front of the

unit.

The control panel layout is shown in Figure 1. The control features are listed

below:

Figure 1: Defend 1050 Control Panel layout.

1. ON/OFF power button

2. LED light indicator for ON/OFF power state

3. Airow speed selection button, reduce airow

4. LED lights (5 lights) indicating the active airow speed

5. Airow speed selection button, increase airow

6. LED light indicator of pressure drop check across HEPA lter

7. Pressure drop check button across HEPA lter

b. Power control

The control button on the furthest left-hand side of the control panel is for

switching the device ON/OFF; the power button. The power button is clearly

illuminated with a blue LED to indicate when the device is on. The blue LED is

illuminated when in the ‘ON’ mode and non-illuminated when the device is in

the ‘OFF’ mode.

c. Airowcontrol

The control allows the user to select the device airow using selection button

‘+’ on the right-hand side for incrementing the air ow setting to a higher airow,

and ‘-’ on the left-hand side for decreasing the air ow setting to a lower air ow.

The air ow setting level is clearly indicated by illuminating a series of blue LEDs

in sequence (from left to right) according to the speed setting (e.g. two LEDs for

speed II, three LEDs for speed III). The Defend 1050 has 5 selectable air ow

speeds.

5 6 7

431 2

Document No. NOV-MNL-103

d. Saveairowtomemory

There is an ability to save a selected airow to memory so the device will revert

to the last known speed on power-on. The last known speed can be saved to

memory by holding the ON/OFF (1) and ‘-‘ (3) buttons for three seconds. To

revert to factory settings and to clear the air speed memory the ON/OFF (1) and

‘+’ (5) buttons are held for three seconds.

e. HEPAFilterreplacementtest

The HEPA lter replacement test indicator is for information purposes only.

The lter replace button, for testing the lter back pressure, is on the furthest

right-hand side of the panel. Upon pressing the lter back pressure test, the

device shall override the air ow setting to speed 5 air ow for testing the

lter for a period of approx. 30 seconds. The test button shall remain backlit

illuminated blue LED while the device is testing the air pressure.

The device will indicate that the HEPA lter needs to be inspected for

replacement by illuminating the test button in orange or a continuous LED light in

orange.

The device will indicate that the HEPA lter does not need to be inspected by

illuminating the test button in green or a continuous light in green.

Novaerus recommends replacing the HEPA lter every twelve-month (12) period

to ensure optimal performance, or when the lter test check output indicates to

do so; whichever comes rst. Discoloration on the HEPA lter may indicate that

the lter 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).

Document No. NOV-MNL-103

7. Service and Maintenance Instructions

a. Service

No serviceable parts are contained within the Defend 1050 unit. The units

should be opened by qualied Novaerus personnel only. The unit is designed

with tamper-proof screws to ensure that it cannot be easily opened by anyone

other than service personnel.

b. Maintenance–ReplacementofFilters

Before replacing lters, ensure the power is switched off at the rear mains switch.

Ensure all lter doors are securely closed before switching the unit back on via

the rear mains switch.

Pre-lter

The intake pre-lter is located behind the front panel of the unit. The pre-lter

should be inspected monthly and be replaced when dirty.

The pre-lter can be removed by unlocking the latch, simply pulling the framing

of the lter outwards and replacing with a new lter.

The metal wire-frame grid should be facing towards the rear of device as shown

in the image below. An airow arrow on the side of the lter shows the correct

direction for the installation of the intake pre-lter screen.

Marking on the Defend 1050 unit corresponding with the required lter.

Markings on the lter to aid placement and correct orientation.

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