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Medtronic / Covidien Products / Pulse Oximetry / Nellcor™ Respiration Rate Product Software, Clinical Studies

Overview

Early Detection of Evolving Respiratory Compromise. Accurate, Easy to Use Single Sensor Technology.

Spot-checking patients on the general care floor can lead to missed signs of respiratory compromise. Nellcor™ Respiration Rate software provides affordable noninvasive, continuous monitoring of respiratory status and may provide an early warning of impending respiratory distress.

Respiration Rate software, when used with SpO2 monitoring, Saturation Pattern Detection (SPD) and the SatSeconds alert feature, provides clinicians with a complete assessment of a patient’s oxygenation and respiration, including trending data in real time, with one integrated sensor. This real-time data displayed on the bedside monitor and delivered to remote monitoring systems, enables clinicians to intervene quickly, minimizing the risk of respiratory compromise.([FOOTNOTE=Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study.Anesthesiology. 2010;112(2):282-287.],[ANCHOR=View Abstract],[LINK=/content/mitg/websites/languagemasters/emea/en-gb/support/clinical-evidence.html?id=337705]),([FOOTNOTE=Aneman A, Parr M. Medical emergency teams: a role for expanding intensive care? Acta Anaesthesiol Scand. 2006;50(10):1255-1265.],[ANCHOR=View Abstract],[LINK=/content/mitg/websites/languagemasters/emea/en-gb/support/clinical-evidence.html?id=603415])

Unlike other methods for calculating respiration rate, which can be unreliable and uncomfortable for the patient, monitoring with Nellcor™ Respiration Rate software is accurate, comfortable for patients, and easy to use.

The addition of respiration rate monitoring to the comprehensive Covidien respiratory function portfolio, reflects our commitment to provide solutions that help clinicians deliver better patient care and help enable faster recovery.

Clinical Indications

Learn More

Product Features

  • Delivers oxygen saturation (SpO2) levels, pulse rate and respiration rate using a single, integrated sensor
  • Provides continuous, noninvasive measurement of respiration rate in adults in hospitals and hospital-type facilities
  • Numbers and trend data are provided and clearly displayed in real time at the bedside and delivered to the central monitoring station
  • Audible and visual alarms for low and high respiration rate

How to Order

For additional information or to place an order, call Customer Service at +44 (0) 19 2320 2504.

Measurement Range 4 to 40 breaths per minute
Accuracy ± 1 breath per minute*
Display/Indicators Real-time numbers
Real-time trend data
Alarms Audible and visual alarms for low and high respiration rate
Low respiration rate alarm fixed at 8 breaths per minute
High respiration rate alarm fixed at 28 breaths per minute

Clinical Indications

Two prospective, observational, non-randomised clinical studies were conducted to demosntrate the accuracy and precision of Nellcor™ Respiration Rate Software (Version 2.0) using the Nellcor™ adult respiratory sensor.

The range of respiration rates observed in the studies was 4 to 32 breaths per minute. Accuracy was calculated using both root mean square difference (RMSD) and mean error. The results demonstrate that Nellcor Respiration Rate software calculates respiration rate with a mean error of less than one breath per minute when compared to respiration rate derived from the capnography-based reference.

Accuracy and precision of Nellcor™ Respiration Rate Software (Version 2.0)
Respiratory Rate Accuracy        
Population  N Accuracy: RMSD (Breaths Per Minute) Accuracy: Mean Error (Breaths Per Minute) Precision: Standard Deviation (Breaths Per Minute)
Healthy Volunteers 30 1.04 0.05 ± 1.04
Hospital Patients 75 2.58 0.53 ± 2.54
All Subjects 105 1.73 0.22 ± 1.72

Nellcor™ Respiration Rate vs clinician overscored respiration rate (Modified Bland-Altman Chart)

Specifications

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  • *Respiration rate accuracy is stated relative to a reference signal obtained from a CO2 waveform. Accuracy of Nellcor™ respiration rate software was established using benchtop testing and clinical studies in 26 healthy volunteers and 53 hospitalized patients. Hospital studies were conducted using convenience sampling and did not necessarily include all patient conditions found in hospitals and hospital-type settings. These clinical study results may not generalize to all patient conditions.

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