Covidien Nellcor GR101704-RR Operator's Manual
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Covidien Nellcor GR101704-RR Operator's Manual

Covidien Nellcor GR101704-RR Operator's Manual

Bedside respiratory patient monitoring system respiration rate version 2.0
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Operator's Manual Addendum
Nellcor™
Bedside Respiratory Patient Monitoring System
Respiration Rate Version 2.0

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Summary of Contents for Covidien Nellcor GR101704-RR

  • Page 1 Operator’s Manual Addendum Nellcor™ Bedside Respiratory Patient Monitoring System Respiration Rate Version 2.0...
  • Page 2 Covidien’s sole responsibility with respect to the equipment and software, and its use, is as stated in the limited warranty provided. Nothing in this manual shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment and software described herein, without notice. In the...

  • Page 3: Table Of Contents

    Table of Contents Nellcor™ Respiration Rate Overview ........ADD-1 Introduction .
  • Page 4 Operator’s Manual Addendum...

  • Page 5: Overview

    For first time activation of the parameter, review the activation kit instructions or contact Covidien for more details. Use this addendum after thoroughly reading the Operator’s Manual. All instructions, other than those listed here, remain the same as those listed in the Operator’s Manual.
  • Page 6 Nellcor™ Respiration Rate Table 1-1.  Additions to the Operator’s Manual Chapter Title Respiration Rate Addition Introduction Additional warnings and cautions Product Overview Additional product description, indications for use state- ments, and monitoring screen examples Installation Refer to separate Activation Instructions Operation Additional sensor usage information, safety messages, menu options, and alarm information Product Data Output Additional data fields in data output...

  • Page 7: Introduction

    It must be used in conjunction with clinical signs and symptoms.  WARNING: Use only Covidien-approved sensors and interface cables when connecting to the sensor port. Connecting any other cable or sensor influences the accuracy of sensor data, which may lead to adverse results.
  • Page 8 Nellcor™ Respiration Rate  Caution: Accuracy of Respiration Rate was established using bench-top testing and clinical studies in 30 healthy volunteers and 75 hospitalized patients. Hospital studies 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.
  • Page 9 Introduction patients with significantly irregular cardiac rhythms have not been established. Use an alternate means of monitoring ventilatory status for patients with significant cardiac dysrhythmia or an implanted pacemaker.  Caution: Safety and effectiveness of Respiration Rate in pediatric and neonatal patients have not been established.

  • Page 10: Related Documents

    Manual — Provides information to qualified service technicians for use when ser- vicing the monitoring system. Warranty Information 1.2.3 To obtain information, if any, contact Covidien or a local Covidien representative. Covidien Technical Services: Patient Monitoring 15 Hampshire Street Mansfield, MA 02048 USA 1.800.635.5267, 1.925.463.4635 (toll)

  • Page 11: Product Overview

    Product Overview Product Overview Product Description 1.3.1 The Covidien Nellcor™ Respiration Rate Version 2.0 parameter as featured on the Nellcor™ Bedside Respiratory Patient Monitoring System allows for con- tinuous noninvasive monitoring of arterial oxygen saturation (SpO ), pulse rate and respiration rate of adult patients using a single sensor. The pulse oximeter collects the photoplethysmography signal from the patient via the Covidien Nellcor™...
  • Page 12 Nellcor™ Respiration Rate The current respiration rate value (in breaths per minute) is shown as a large white numeral on the right side of the display. Upper and lower alarm limits are user-adjustable. Figure 1-1.  Respiration Rate (RR) Fields Respiration rate Indicates the respiration rate in breaths per minute. (breaths/min) value Respiration rate upper Upper/lower alarm limit settings appear as smaller...
  • Page 13 Product Overview Pleth View Figure 1-2.  Pleth View with Respiration Rate Trend View Figure 1-3.  Trend View with Respiration Rate Operator’s Manual Addendum ADD-9...
  • Page 14 Nellcor™ Respiration Rate Combined Pleth and Trend View Figure 1-4.  Combined View with Respiration Rate Numbers Only (Blip) View Figure 1-5.  Blip View with Respiration Rate ADD-10 Operator’s Manual Addendum...

  • Page 15: Updated Monitoring History Screens

    Product Overview Updated Monitoring History Screens 1.3.4 Similar to the real-time trend views, the monitoring history trend views include the new respiration rate field at the lower right and respiration rate trend data in white below the SpO and pulse rate data. Respiration data is also docu- mented in the clinical log and histogram view.
  • Page 16 Nellcor™ Respiration Rate Monitoring History - Clinical Log Figure 1-7.  MONITORING HISTORY -Clinical Log Monitoring History - Histograms Figure 1-8.  MONITORING HISTORY - Histograms ADD-12 Operator’s Manual Addendum...

  • Page 17: Operation

    Operation Operation When used with a respiratory sensor, the Respiration Rate parameter provides a continuous, non-invasive measurement of respiration rate, in breaths per minute, for adults in hospitals or hospital-type facilities. Respiration rate is derived by analysis of changes in the photoplethysmogram (PPG) signal that occur during the respiratory cycle.

  • Page 18: Required Pulse Oximetry Sensor Usage

    Nellcor™ Respiration Rate Required Pulse Oximetry Sensor Usage 1.4.2 To obtain respiration rate, caregivers must use a Nellcor™ Adult Respiratory Sensor. The monitoring system reports the appropriate sensor type in the message field when it detects the sensor. Figure 1-9.  Sample Sensor Type Message If caregivers use non-respiratory sensors, listed in the Operator’s Manual, the monitoring system continues to post both SpO and pulse rate data, with the...

  • Page 19: Respiration Rate Safety Information

    Operation Respiration Rate Safety Information 1.4.3 Upon connection of the respiratory sensor to the monitoring system, you are prompted to review on-screen Respiration Rate safety information. To review the safety information Press EXIT, then press HELP. Select RR Safety Information from the Help options, and review the safety infor- mation.
  • Page 20 Nellcor™ Respiration Rate Figure 1-12.  ALARM LIMITS Menu Options  Note: The initial alarm limits are the factory default settings or the institutional default settings set by qualified service personnel. Any changes to these settings are temporary. Limit changes remain in effect as long as the monitoring system retains power, but return to the factory or institutional default settings at power off.
  • Page 21 Operation Figure 1-13.  Adjusting Respiration Rate Alarm Limits Press SAVE CHANGES. Press EXIT. Confirm that the new limits appear in the respiration rate limit area on the moni- toring screen. Operator’s Manual Addendum ADD-17...
  • Page 22 Nellcor™ Respiration Rate MONITORING SETTINGS Menu - Real-Time Respiration Rate Data For monitoring views that include real-time trend data, the SELECT TRENDS menu includes options to display SpO , pulse rate, respiration rate, or any com- bination of these selections. Figure 1-14.  Initial Select Trends Screen ADD-18 Operator’s Manual Addendum...

  • Page 23: Additional Alarm Messages

    Data Output Additional Alarm Messages 1.4.5 As with SpO and pulse rate alarms, when a respiration rate alarm is active, the value in that field turns black on a yellow background. Figure 1-15.  Sample Alarm Condition Several new alarms and message accompany the Respiration Rate parameter. Reference Troubleshooting, p.
  • Page 24 Nellcor™ Respiration Rate Figure 1-16.  Historical Trend Data Export with Respiration Rate Values Time stamp Alarm type High and low readings Pulsatile strength minimum/maximum Upper and lower limits Sample interval (period in seconds) Respiration rate data ADD-20 Operator’s Manual Addendum...
  • Page 25 Data Output Table 1-3 describes the respiration rate data in the historical trend data output. Refer to the Operator’s Manual for descriptions of the other data in the output. Table 1-3.  Historical Trend Data Output Definitions (Respiration Rate Data Only) Column Description RR Max Maximum respiration rate value observed within the 1-sec.

  • Page 26: Performance Considerations

    Nellcor™ Respiration Rate Performance Considerations Monitoring System Constraints 1.6.1 In addition to the pulse rate and saturation constraints listed in the Operator’s Manual, the following constraint applies: Respiration Rate — The monitoring system displays respiration rate levels from • 4 to 40 breaths per minute (breaths/min). Detected breaths/min above 40 appear as 40.

  • Page 27: Troubleshooting

    Troubleshooting Troubleshooting Existing troubleshooting and error codes remain the same as those listed in the Operator’s Manual. Additional messages and errors related to the Respiration Rate parameter follow.  Note: The Respiration Rate parameter is approved for use in the range 4 to 40 breaths per minute.
  • Page 28 Nellcor™ Respiration Rate Table 1-4.  Additional Alarm, Error, and Status Messages (Continued) Message Description Unable to Calculate Error: The monitoring system is unable to calculate a respiration rate value because the SpO or pulse rate value is unavailable. Resolution: Check for correct application and placement of sensor, as •...

  • Page 29: Additional Nellcor™ Pulse Oximetry Sensor

    Use the recommended sensor’s Instructions for Use to guide sensor selection or contact Covidien or a local Covidien representative. Reference Nellcor™...
  • Page 30 Nellcor™ Respiration Rate Respiratory sinus arrhythmia (RSA) — During the respiratory cycle, heart rate generally increases during inspiration and decreases during expiration. RSA results in pulse frequency variations. Reference Figure 1-17 (d). Figure 1-17.  Variations of the pleth due to respiration The Respiration Rate parameter utilizes these subtle pleth variations to measure respiration rate.

  • Page 31: Specifications

    Specifications Specifications 1.10 Product specifications remain the same as those listed in the Operator’s Manual, with the exception of the Nellcor™ Adult Respiratory Sensor data. Table 1-6.  Nellcor™ Adult Respiratory Sensor Accuracy and Ranges Measurement Range Pulse Oximetry Saturation (SpO 1% to 100% Pulse Rate 20 to 250 beats per minute (bpm) Perfusion Range...

  • Page 32: Clinical Studies

    Nellcor™ Respiration Rate Table 1-7.  Nellcor™ Adult Respiratory Sensor Operating Range and Power Dissipation Operating Range and Dissipation Red Light Wavelength Approximately 660 nm Infrared Light Wavelength Approximately 900 nm Optical Output Power Less than 15 mW Power Dissipation 52.5 mW Clinical Studies 1.11 Two (2) prospective, observational, non-randomized clinical studies were conduct- ed to demonstrate the accuracy of Respiration Rate Version 2.0 when used in con-...

  • Page 33: Study Results

    Clinical Studies Study Results 1.11.3 Results for Respiration Rate Version 2.0 are shown in Table 1-9. The observed respiration rate range in the studies was 4 to 32 breaths per minute. Accuracy was calculated using both root mean square difference (RMSD) and mean error.
  • Page 34 Nellcor™ Respiration Rate Figure 1-18.  Modified Bland-Altman Plot of Nellcor Respiration Rate Software versus Clinician Over- scored Respiration Rate Difference (Clinician Overscored Respiration Upper 95% LoA Rate - Nellcor Respiration Rate, BrPM) Mean Clinician Overscored Respiration Rate (BrPM) Lower 95% LoA Table 1-10, Local Bias with Respect to Reference Respiratory Rate, the hos- pital data is broken into sub-ranges of respiration rate.

  • Page 35: Adverse Events

    Clinical Studies Adverse Events 1.11.4 No adverse events were reported during the studies. Conclusion 1.11.5 In clinical studies of healthy subjects and hospitalized patients, Respiration Rate, Version 2.0 provided respiration rate with an accuracy of ± 1 breath per minute when compared to respiration rate derived from a capnography-based reference.
  • Page 36 Nellcor™ Respiration Rate Page Left Intentionally Blank ADD-32 Operator’s Manual Addendum...
  • Page 38 Part No. 10104355 Rev L 2015-06 © 2013 Covidien.  Covidien Ireland Limited, IDA Business and Technology Park, Tullamore.  Covidien llc 1.800.255.6774 [T] www.covidien.com 15 Hampshire Street Mansfield, MA 02048 USA...

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