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Operator’s Manual Addendum

Table of Contents

Nellcor™ Respiration Rate

1.1

Overview

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-1

1.2

Introduction

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-3

1.2.1 Safety Symbol Definitions

. . . . . . . . . . . . . . . . . . . . . . . . ADD-3

1.2.2 Related Documents

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-6

1.2.3 Warranty Information

. . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-6

1.3

Product Overview

. . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-7

1.3.1 Product Description

. . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-7

1.3.2 Indications for Use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-7

1.3.3 Updated Monitoring Screens

. . . . . . . . . . . . . . . . . . . . . ADD-7

1.3.4 Updated Monitoring History Screens

. . . . . . . . . . . . . . . ADD-11

1.4

Operation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-13

1.4.1 Prerequisites

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-13

1.4.2 Required Pulse Oximetry Sensor Usage

. . . . . . . . . . . . . ADD-14

1.4.3 Respiration Rate Safety Information

. . . . . . . . . . . . . . . ADD-15

1.4.4 Menu Options

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-15

1.4.5 Additional Alarm Messages

. . . . . . . . . . . . . . . . . . . . . . ADD-19

1.5

Data Output

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-19

1.6

Performance Considerations

. . . . . . . . . . . . . . . . . . . ADD-22

1.6.1 Monitoring System Constraints

. . . . . . . . . . . . . . . . . . . ADD-22

1.6.2 Nellcor™ Sensor Performance Considerations

. . . . . . . . ADD-22

1.6.3 Patient Conditions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-22

1.7

Troubleshooting

. . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-23

1.8

Additional Nellcor™ Pulse Oximetry Sensor

. . . . . . ADD-25

1.9

Theory of Operations

. . . . . . . . . . . . . . . . . . . . . . . . ADD-25

1.10

Specifications

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-27

1.11

Clinical Studies

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-28

1.11.1 Methods

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-28

1.11.2 Study Population

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-28

1.11.3 Study Results

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-29

1.11.4 Adverse Events

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-31

1.11.5 Conclusion

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-31

Содержание Nellcor GR101704-RR

Страница 1: ...Operator s Manual Addendum Nellcor Bedside Respiratory Patient Monitoring System Respiration Rate Version 2 0...

Страница 2: ...chnical Services While the information set forth herein is believed to be accurate it is not a substitute for the exercise of professional judgment The equipment and software should only be operated a...

Страница 3: ...equired Pulse Oximetry Sensor Usage ADD 14 1 4 3 Respiration Rate Safety Information ADD 15 1 4 4 Menu Options ADD 15 1 4 5 Additional Alarm Messages ADD 19 1 5 Data Output ADD 19 1 6 Performance Cons...

Страница 4: ...ii Operator s Manual Addendum...

Страница 5: ...and pulse rate data but augments it To obtain respiration rate data caregivers must use a Nellcor Adult Respira tory Sensor The parameter provides alarms for high and low respiration rate Settings fo...

Страница 6: ...peration Additional sensor usage information safety messages menu options and alarm information 5 Product Data Output Additional data fields in data output 6 Performance Considerations Additional moni...

Страница 7: ...ING External factors including certain ambient conditions sensor application errors and certain patient conditions may compromise the accuracy of the displayed respiration rate value Always consider c...

Страница 8: ...e monitoring system Reliance on respiration rate information alone is not recommended Health care personnel should always consider clinical signs and symptoms when assessing the patient and before int...

Страница 9: ...n Safety and effectiveness of Respiration Rate in patients on mechanical ventilation have not been established Caution An SpO2 alarm may be the first indication of hypoventilation Caution A low SpO2 a...

Страница 10: ...Covidien approved Nell cor sensors to the monitoring system refer to their Instructions for Use Nellcor Oxygen Saturation Accuracy Specification Grid Provides sensor specific guidance related to desir...

Страница 11: ...tion use only as a continuous non invasive monitor of arterial oxygen saturation SpO2 and pulse rate of adult pediatric and neonatal patients during both motion and no motion conditions and for patien...

Страница 12: ...Respiration Rate RR Fields Note The monitoring system displays respiration rate levels from 4 to 40 breaths min Detected breaths min above 40 appear as 40 Detected breaths min below 4 appear as 4 1 R...

Страница 13: ...Product Overview Operator s Manual Addendum ADD 9 Pleth View Figure 1 2 Pleth View with Respiration Rate Trend View Figure 1 3 Trend View with Respiration Rate...

Страница 14: ...ellcor Respiration Rate ADD 10 Operator s Manual Addendum 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...

Страница 15: ...tion rate field at the lower right and respiration rate trend data in white below the SpO2 and pulse rate data Respiration data is also docu mented in the clinical log and histogram view Monitoring Hi...

Страница 16: ...llcor Respiration Rate ADD 12 Operator s Manual Addendum Monitoring History Clinical Log Figure 1 7 MONITORING HISTORY Clinical Log Monitoring History Histograms Figure 1 8 MONITORING HISTORY Histogra...

Страница 17: ...iration rate alarms are triggered immediately when the reported rate falls outside the alarm limits and no further alarm delay is applied 1 4 1 Prerequisites Before starting a monitoring session confi...

Страница 18: ...tem continues to post both SpO2 and pulse rate data with the user message NO RR SENSOR CONNECTED and dashes in the RR field Figure 1 10 RR field with No RR Sensor Message If caregivers use a respirato...

Страница 19: ...ions specific to Respiration Rate are described below ALARM LIMITS Menu Respiration Rate Alarm Limits The ALARM LIMITS menu includes an option for setting upper and lower res piration rate alarm limit...

Страница 20: ...ry 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 To temporarily change respiration rate alarm l...

Страница 21: ...ator s Manual Addendum ADD 17 Figure 1 13 Adjusting Respiration Rate Alarm Limits 5 Press SAVE CHANGES 6 Press EXIT 7 Confirm that the new limits appear in the respiration rate limit area on the moni...

Страница 22: ...G SETTINGS Menu Real Time Respiration Rate Data For monitoring views that include real time trend data the SELECT TRENDS menu includes options to display SpO2 pulse rate respiration rate or any com bi...

Страница 23: ...ondition Several new alarms and message accompany the Respiration Rate parameter Reference Troubleshooting p ADD 23 for descriptions and recommended res olutions 1 5 Data Output Respiration rate data...

Страница 24: ...Addendum Figure 1 16 Historical Trend Data Export with Respiration Rate Values 1 Time stamp 5 Alarm type 2 High and low readings 6 Pulsatile strength minimum maximum 3 Upper and lower limits 7 Sample...

Страница 25: ...limit for respiration rate as configured by the user RR UL Upper alarm limit for respiration rate as configured by the user Alarms Encoded number indicating which alarms were active during the 1 sec...

Страница 26: ...for use are not applicable to Nellcor Respiration Rate 1 6 2 Nellcor Sensor Performance Considerations All sensor performance considerations described in the Operator s Manual apply to use of the Nel...

Страница 27: ...escription Low Respiration Rate Alarm The patient s respiration rate is below the low alarm limit Resolution Assess patient condition in conjunction with SpO2 and pulse rate readings from the monitori...

Страница 28: ...on rate is 0 5 of pulse rate Resolution Assess patient condition in conjunction with SpO2 and pulse rate readings from the monitoring system to determine appropri ate intervention Use an alternate mea...

Страница 29: ...signal is used to measure arterial oxygen saturation SpO2 A typical pleth pattern includes a regular cardiac pulse waveform on top of a large con stant baseline component or DC component See Figure 1...

Страница 30: ...eases 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 pl...

Страница 31: ...imeter equipment measurements are statistically distributed about two thirds of the measurements can be expected to fall in this accuracy ARMS range refer to the Sensor Accuracy Grid for more details...

Страница 32: ...hy vol unteers and 75 hospitalized patients Subjects were studied for approximately 30 minutes during which data from capnography and the Nellcor pulse oxim eter were collected Respiration rate was de...

Страница 33: ...observations between Respiration Rate Version 2 0 and the capnography based reference method Figure 1 18 p ADD 30 presents a modified Bland Altman plot of these paired observations to provide another...

Страница 34: ...e The limits of agreement were derived from data in each respiration rate sub range and are provided in Table 1 10 1 Difference Clinician Overscored Respiration Rate Nellcor Respiration Rate BrPM 3 Up...

Страница 35: ...d 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 Hosp...

Страница 36: ...Page Left Intentionally Blank ADD 32 Operator s Manual Addendum Nellcor Respiration Rate...

Страница 37: ......

Страница 38: ...art 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 US...

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