NIOX MINO User Manual
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NIOX MINO User Manual

External quality control
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E N G L I S H
NIOX MINO
®
External Quality Control
User Manual

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Summary of Contents for NIOX MINO

  • Page 1 E N G L I S H NIOX MINO ® External Quality Control User Manual...
  • Page 2 Note! This manual is an appendix to the NIOX MINO User Manual. ® It describes the optional external Quality Control procedure for NIOX MINO. Please refer to the NIOX MINO User Manual for more information.

  • Page 3: Table Of Contents

    Information in this document is subject to change. Amendments will be made available by Aerocrine AB as they occur. • NIOX MINO is CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use in EEC countries.

  • Page 4: Warning

    2. Select QC settings baths (either open vessels or ultrasonic baths). • NIOX MINO should not be used adjacent to or stacked with other equipment. 3. The QC settings are shown • The NIOX MINO Sensor contains chemicals that could be harmful if swallowed.

  • Page 5: Selection And Qualification Of Qc Testers

    QC tester to be qualified. The following measurement according QC measurement on the fourth day must be to the NIOX MINO user within ±10 ppb from the mean value and the NO manual Scrubber result < 5 ppb. Once the Quality Control has been completed the instrument is ready for clinical use.

  • Page 6: View Stored Qc Results

    C. QC sequence number Repeat the QC measurement if the positive and/ or the negative controls fail. If QC fail persists, 5. Use the previous and next discontinue use of NIOX MINO and contact ® buttons to step through your local Aerocrine representative or Aerocrine the results Customer Support.

  • Page 7: Reset Qc Tester

    4. The QC information is Code Action displayed: There has been an attempt to perform A. Mean QC F NO value several QC measurements on the and latest moving same day with the same test person. mean date for QC Wait one day and perform the next QC testers 1 and 2 measurement.
  • Page 8 Patents: Circassia’s NIOX products are protected by a number of patents in the US, Europe and a range of other countries. A N E W D I M EN S I O N IN A S T H M A C A R E Circassia AB, an ISO 13485 certified company Circassia AB, Råsundavägen 18, SE-169 67 Solna, Sweden...

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