Aerocrine Ltd

Nitric Oxide Monitoring System

NIOX MINO User Manual Ver 9 Dec 2014

User Manual

28 Pages

Table of contents Warnings! ... 2 Intended use ...  2 Training requirements ...  Presentation ...  Installation and set-up ...  Measurement ... 5 Enter patient ID (optional)...  Perform FeNO measurement...  6 View stored results ...  7 Ambient NO measurement ... 7 Demonstration mode ... 7 Change settings ... 8 Time and date...  Sound volume...  8 Top light intensity...  Mode configuration - QC on/off...  Information menu ...  External Quality Control procedure (QC) ... 10 Selection and qualification of QC testers...  10 QC measurement...  11 View stored QC results...  12 View QC information... 12 Reset QC tester...  12 Turn off NIOX MINO® ...  13 Moving NIOX MINO...  13 General Care ... 3 Preventive inspections... 3 Change Sensor... 3 Change NO scrubber...  14 Disposal of used/expired products... 4 Return shipments...  14 Support...  14 Limited warranty... 4 Troubleshooting ... 15 Alert codes...  16 Technical data ... 17 Display buttons and symbols...  17 Symbols explanation... 9 Backplate...  19 Base label ... 9 Dimensions and weight... 19 Electrical data... 19 Noise level (stand by)... 19 Shelf-life... 9 Operating conditions...  19 Exhaled NO - performance data... 0 Linearity... 0 Precision... 0 Accuracy...  20 Method comparison... 20  Inhalation parameters... 20 Exhalation parameters... 20 Memory capacity...  20 Transport and storage...  20 Patient filter (mouthpiece)... 20 Responsible manufacturer... 20 NIOX MINO® parts and accessories ... 1 Connect NIOX MINO® to a PC using USB ...  21 NIOX® Panel ... 1 Cautions ... 22 NIOX MINO surveillance procedures ... 24 Clinical documentation ...  24 Medical Device Reporting (MDR) ... 25 Guidance and manufacturer's declaration ... 5 Electromagnetic emissions... 5  User manual 000164 (EPM-000109), version 9, December 2014, for instruments with software version from 2005 to 20XX and 22XX to 23XX...  can be any number between 0 and 9... he version number for your instrument can be seen in the Information menu, see page 9... nformation in this document is subject to change... mendments will be made available by Aerocrine, Inc... s they occur...  NIOX MINO is 510(k) cleared, K101034, by FDA...  NIOX MINO is CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use in EEC countries...  NIOX MINO is RoHS compliant...  Copyright © 2014 Aerocrine AB, Solna, Sweden...  Aerocrine, NIOX MINO and NIOX are registered trademarks of Aerocrine AB...
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File Name: niox_mino_user_manual_ver_9_dec_2014.pdf

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