Related Manuals for NOVAERUS Defend 1050
Summary of Contents for NOVAERUS Defend 1050
- Page 1 Defend 1050 User Manual (NV1050) Novaerus, US Inc. 35 Melrose Pl. Stamford, CT 06902 FDA Cleared Phone: 1.866.515.5181 510(k) Class II Medical Device www.novaerus.com Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
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Page 2: Table Of Contents
Table of Contents ..........3 1. -
Page 3: Intended Purpose
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). -
Page 4: Classification Of Equipment
Use two or more people to move and handle this unit. Failure to do CAUTION: so can result in back or other injury. Carefully remove the packaging materials and any shipping tape before using. This equipment contains high voltage CAUTION: Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US... - Page 5 CAUTION: serviceable parts are contained within. The units should be opened by qualified Novaerus personnel only. Do not use other filters except those supplied by Novaerus. The use CAUTION: of other brand or no-brand filters with the NV1050 will invalidate the claims that can be made for the performance of the NV1050.
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Page 6: Technical Specifications
IEC 60601-1-2, Fourth Edition UL 867 Safety for Electrostatic Air Weight Approx. 118.6 lbs Cleaners FDA K200321.510(k) Class II Medical Device Electrical Connection: Switched and fused with a grounded, molded and detachable power cord. Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US... -
Page 7: Instructions For Use
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 floor standing unit only. - Page 8 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.
- Page 9 The device will indicate that the HEPA filter does not need to be inspected by illuminating the test button in green or a continuous light in green. Novaerus recommends replacing the HEPA filter every twelve-month (12) period to ensure optimal performance, or when the filter test check output indicates to do so;...
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Page 10: Service And Maintenance Instructions
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. - Page 11 The Carbon filter should be removed before gaining access to the HEPA filter. Marking on the Defend 1050 unit correspond with the required filter. The Carbon and HEPA filters are fitted with a handle that can be used to pull the filter out of its housing in the Defend 1050 unit.
- Page 12 (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.
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Page 13: Filter Disposal
Clean the body of the Defend 1050 regularly to prevent dust from collecting. Wipe away dust from the body of the device with a soft dry cloth. -
Page 14: 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. -
Page 15: Appendix A. Guidance And Manufacturer's Declarations
Harmonic emissions EN domestic and those directly Complied 61000-3-2 connected to the public low- voltage power supply network Voltage fluctuations / that supplies buildings used for flicker emissions Complied domestic purposes. EN 61000-3-3 Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US... - Page 16 Mains power quality differential mode Surge EN differential should be that of a 61000-4-5 mode +/- 2 kV typical commercial or +/- 0.5, 1 & 2 kV common mode hospital environment. common mode Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
- Page 17 30 A/m 30 A/m characteristic of a field typical location in a typical commercial or EN 61000- hospital environment. NOTE: Ut is the a.c.mains voltage prior to application of the test level. Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
- Page 18 28 V/m, 217 Hz PM is the recommended 930 MHz 1845 MHz separation distance 28V/m, 217 Hz PM 28 V/m, 217 Hz PM 1720 MHz 1970 MHz 27 V/m, 217 Hz PM 2450 MHz Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
- Page 19 If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the NV1050. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m. Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
- Page 20 NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Document No. NOV-MNL-103 COPYRIGHT ©2021 Novaerus, US...
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