Defend 1050 User Manual (NV1050) FDA Cleared 510(k) Class II Medical Device Novaerus, US Inc. 35 Melrose Pl. Stamford, CT 06902 Phone: 1.866.515.5181 www.novaerus.com Document No.
Table of Contents 1. Intended Purpose ������������������������������������������������������������������������������������������������� 3 2. Labeling Symbols ��������������������������������������������������������������������������������������������������� 3 3. Classification of Equipment ������������������������������������������������������������������������������� 4 4. Warnings ��������������������������������������������������������������������������������������������������������������� 4 5.
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.
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. Classification of Equipment Item Classification 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.
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 flashover or a risk of fire. CAUTION: No modification of this equipment is allowed. CAUTION: Do not modify this equipment without authorization of the manufacturer. CAUTION: Do not restrict the air flow of the product.
5. Technical Specifications 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.
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 firmly 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.
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: 1 2 3 4 5 6 7 Figure 1: Defend 1050 Control Panel layout. 1. 2. 3. 4. 5. 6. 7.
d. Save airflow to memory There is an ability to save a selected airflow 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 filter replacement test indicator is for information purposes only.
7. Service and Maintenance Instructions a. Service No serviceable parts are contained within the Defend 1050 unit. The units should be opened by qualified 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 filters, ensure the power is switched off at the rear mains switch.
It is recommended to replace this filter after three (3) months of continuous use. It is recommended that the user inspect the intake pre-filter screen monthly during the first 2 months of use to determine the most appropriate cleaning period for its facility. If dust and debris has collected on the intake screen sufficient enough to cause a significant decrease in airflow, more frequent replacement of this filter may be required. Only Novaerus supplied replacement filters should be used.
Markings on the filter to aid placement and correct orientation. The expected lifetime of the Carbon filter is approximately four months (4) under normal clean air conditions (such as that of a hospital ward). It is recommended to replace this filter after four (4) months of continuous use. Only Novaerus supplied replacement filters should be used. Please contact Novaerus Customer Service for replacement filters. HEPA Filter The HEPA filter can be accessed from the top panel, see illustration below.
8. Filter Disposal The pre-filter, HEPA and carbon filters are throw-away, dry type air filter units. The following instructions are for filter disposal for filters used in non-hazardous environments: To properly dispose of a used non-hazardous air filter: • Before you begin, turn off the unit • Have a plastic bag on hand • Carefully remove the used air filter from the Defend 1050 unit • Place the filter gently into the bag, without shaking it.
10. Troubleshooting Should the unit sustain severe damage and an increase in noise from the internal parts is observed, discontinue use of the unit and contact a representative of the Novaerus technical team for assistance. This product is not intended to be repaired in the field. To ensure the Defend 1050 unit’s optimal functionality when replacing the filters, the power must be switched off at the rear mains switch before attempting to open the filter doors.
12. APPENDIX A. Guidance and Manufacturer’s Declarations Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions – for all equipment and systems Guidance and manufacturer’s declaration – electromagnetic immunity The NV1050 is intended for use in the electromagnetic environment specified below. The customer or the user of the NV1050 should assure that it is used in such an environment.
Table 202 – Guidance and manufacturer’s declaration – electromagnetic immunity – for all equipment and systems Guidance and manufacturer’s declaration – electromagnetic immunity The NV1050 is intended for use in the electromagnetic environment specified below. The customer or the user of the NV1050 should assure that it is used in such an environment.
continued… Voltage dips, short interruptions and voltage variations on power supply input lines EN 610004-11 Power frequency (50/60 Hz) magnetic field EN 610004-8 <5 % Ut (>95 % dip in Ut) for 0.5 cycle @ 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° 70 % Ut (30 % dip in Ut) for 25 cycles <5 % Ut (>95 % dip in Ut) for 5 sec 30 A/m <5 % Ut (>95 % dip in Ut) for 0.
Table 203 – Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting Guidance and manufacturer’s declaration – electromagnetic immunity The NV1050 is intended for use in the electromagnetic environment specified below. The customer or the user of the NV1050 should assure that it is used in such an environment.
continued… 28 V/m, 217 Hz PM 1845 MHz 28 V/m, 217 Hz PM 1970 MHz 27 V/m, 217 Hz PM 2450 MHz 9V/m, 217 Hz PM 5240 MHz 9 V/m, 217 Hz PM 5500 MHz 9 V/m, 217 Hz PM 5785 MHz 9V/m, 217 Hz PM 5240 MHz 9 V/m, 217 Hz PM 5500 MHz 9 V/m, 217 Hz PM 5785 MHz in meters (m), field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b.
Table 204 – Recommended separation distances between portable and mobile RF communications equipment and the equipment and system – for equipment and systems that are not life supporting Recommended separation distances between portable and mobile RF communication equipment and the NV1050. The NV1050 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
