Covidien Nellcor GR101704-RR User manual

Operator’s Manual Addendum
Nellcor™
Bedside Respiratory Patient Monitoring System
Respiration Rate Version 2.0

COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and
internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covi-
dien company.
©2013 Covidien. All rights reserved.
The information contained in this manual is the sole property of Covidien and may not be
duplicated without permission. This manual may be revised or replaced by Covidien at any time
and without notice. It is the responsibility of the reader to have the most current applicable
version of this manual. If in doubt, contact Covidien Technical 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 and serviced by trained professionals.
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
absence of an express, written agreement to the contrary, Covidien has no obligation to
furnish any such revisions, changes, or modifications to the owner or user of the equipment
and software described herein.

Operator’s Manual Addendum i
Table of Contents
1 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

ii Operator’s Manual Addendum

ADD-1
1 Nellcor™ Respiration Rate
1.1 Overview
This Operator’s Manual addendum describes the operation of the
Nellcor™ Respiration Rate Version 2.0 parameter when used with the
Nellcor™ Bedside Respiratory Patient Monitoring System.
This addendum applies to the following products:
GR101704-RR*
PM1000N-RR
The parameter provides caregivers with respiration rate information on
patients. The parameter does not require modification of other monitoring
system settings. Continue to use the monitoring system as before for monitor-
ing SpO2and pulse rate, while also monitoring for respiration rate. The param-
eter does not in any way replace SpO2and 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 for the alarm thresholds are user-adjustable. The parameter has an
operating range of 4 to 40 breaths per minute, with an accuracy of ± 1 breath
per minute, relative to a capnography-based reference.
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. This addendum only contains information relevant to
Respiration Rate parameter usage.
* with the PMMOD30N and PMSW-1000N-V2.0 upgrade kits applied
Version 2.0

Nellcor™ Respiration Rate
ADD-2 Operator’s Manual Addendum
Table1-1.Additions to the Operator’s Manual
Chapter Title Respiration Rate Addition
1 Introduction Additional warnings and cautions
2 Product Overview Additional product description, indications for use state-
ments, and monitoring screen examples
3 Installation Refer to separate Activation Instructions
4 Operation 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 monitoring system constraint and patient condi-
tion considerations
7 Product Maintenance ---
8 Troubleshooting Additional error conditions
9 Accessories Additional sensor
10 Theory of Operations Additional parameter
11 Product Specifications Additional sensor accuracy and range data
Appendix A Clinical Studies Additional clinical study data specific to Respiration Rate

Introduction
Operator’s Manual Addendum ADD-3
1.2 Introduction
1.2.1 Safety Symbol Definitions
This section contains safety information requiring users to exercise appropriate
caution while using the monitoring system.
WARNING:
The monitoring system is intended only as an adjunct in patient assessment.
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.
WARNING:
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 clinical signs and symptoms
when assessing the patient and before intervening in response to a
respiration rate alarm.
WARNING:
Respiration Rate is not intended for use as an apnea monitor. During apnea,
Respiration Rate may post a non-zero number.
Table1-2.Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.

Nellcor™ Respiration Rate
ADD-4 Operator’s Manual Addendum
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. Use caution in patient populations in which a displayed
respiration rate value outside of the stated accuracy specification could
present a serious risk or hazard.
Caution:
Respiration Rate provides an indicator of central ventilatory drive and not a
direct indication that air is moving through the upper airway. Always
consider clinical signs and symptoms when assessing the patient and before
intervening in response to a respiration rate alarm.
Caution:
Respiration Rate should be used only in conjunction with the SpO2and pulse
rate information provided by the 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 intervening in response to a respiration rate alarm.
Caution:
Periods of continuous patient motion may impact device performance. During
prolonged periods of motion, Nellcor Respiration Rate may not report a
respiration rate value. In situations where respiration rate is not reported,
and is the only measurement affected by signal quality, the monitoring
system will indicate “RR Interference.”
Caution:
The operating range for Respiration Rate is 4 to 40 breaths per minute. Use
on patients with respiration rates outside this range may result in inaccurate
displayed respiration rate values.
Caution:
Respiration Rate should not be used on patients with significantly irregular
cardiac rhythms (defined as three or more events of irregularity observed
within 30 seconds) because the presence of these irregular cardiac rhythms
may cause inaccurate respiration rate values or the loss of displayed
respiration rate information. Safety and effectiveness of Respiration Rate in

Introduction
Operator’s Manual Addendum ADD-5
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.
Caution:
Safety and effectiveness of Respiration Rate in pregnant or lactating women
have not been established.
Caution:
Safety and effectiveness of Respiration Rate in patients on mechanical
ventilation have not been established.
Caution:
An SpO2alarm may be the first indication of hypoventilation.
Caution:
A low SpO2alarm limit of at least 90% is recommended when monitoring
patients on supplemental oxygen.
Caution:
Use of the Respiration Rate parameter does not change the need to set
threshold limits appropriate to the patient being monitored.
Caution:
Nellcor Respiration Rate performance has not been established during cases
of extreme motion (for example seizure) or poor perfusion (for example
shock). In cases of extreme motion or poor perfusion other forms of
respiration rate monitoring are recommended.

Nellcor™ Respiration Rate
ADD-6 Operator’s Manual Addendum
1.2.2 Related Documents
•Nellcor™ Respiration Rate Upgrade Kit Version 2.0 - Activation Instruc-
tions — Provides instructions for activating the Respiration Rate parameter on the
Nellcor™ Bedside Respiratory Patient Monitoring System. The activation proce-
dure must be performed by a qualified technician.
•Nellcor™ Bedside Respiratory Patient Monitoring System Operator’s
Manual — Provides basic information on operating the monitoring system and
troubleshooting errors or malfunctions. Before using the monitoring system, thor-
oughly read this manual.
•Nellcor™ Pulse Oximetry Sensor Instructions for Use — Guides sensor
selection and usage. Before attaching any of the various 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 desired SpO2saturation accuracy measure-
ments. Available online at www.covidien.com.
•Nellcor™ Bedside Respiratory Patient Monitoring System Service
Manual — Provides information to qualified service technicians for use when ser-
vicing the monitoring system.
1.2.3 Warranty Information
To obtain information, if any, contact Covidien or a local Covidien representative.
Purchase of this instrument confers no express or implied license under any
Covidien patent to use that instrument with any sensor not manufactured or
licensed by Covidien llc.
Covidien Technical Services: Patient Monitoring
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
or contact a local Covidien representative
www.covidien.com

Product Overview
Operator’s Manual Addendum ADD-7
1.3 Product Overview
1.3.1 Product Description
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 (SpO2), 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™ Adult Respiratory Sensor attached to the patient. This signal is pro-
cessed by the pulse oximeter to determine patient SpO2and pulse rate data,
which are displayed on the monitor user interface along with trending, system
status, and alarm information. These data are stored on the monitor and avail-
able for subsequent export.
1.3.2 Indications for Use
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse
oximeter intended for prescription use only as a continuous non-invasive
monitor of arterial oxygen saturation (SpO 2 ) and pulse rate of adult, pediatric,
and neonatal patients during both motion and no motion conditions, and for
patients who are well or poorly perfused. The monitoring system is intended for
use in hospitals, hospital-type facilities, and during intra-hospital transport. The
OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults
to detect patterns of desaturation indicative of repetitive reductions in airflow
through the upper airway and into the lungs.
The Nellcor™ Respiration Rate parameter, when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Adult
Respiratory Sensor, is intended for the continuous, non-invasive monitoring of
respiration rate in adult patients in hospitals and hospital-type facilities.
1.3.3 Updated Monitoring Screens
The user interface components remain the same as those listed in the Opera-
tor’s Manual, with the addition of the new respiration rate field at the lower
right of the monitoring screen. In trend views, respiration rate data is shown
as a white trend line.

Nellcor™ Respiration Rate
ADD-8 Operator’s Manual Addendum
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
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 Respiration rate
(breaths/min) value
Indicates the respiration rate in breaths per minute.
2 Respiration rate upper
and lower limits
Upper/lower alarm limit settings appear as smaller
values to the right of the dynamic respiration rate value.
1
2

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

Nellcor™ 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

Product Overview
Operator’s Manual Addendum ADD-11
1.3.4 Updated Monitoring History Screens
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 SpO2and pulse rate data. Respiration data is also docu-
mented in the clinical log and histogram view.
Monitoring History - Trends
Figure1-6.MONITORING HISTORY - Trends with Data Pop-up
Note that trend data pop-up windows (in both real-time and historical trend
data views) also include respiration rate data.

Nellcor™ 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 - Histograms

Operation
Operator’s Manual Addendum ADD-13
1.4 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. Extremes of respiration rate and/or signifi-
cant changes in respiration rate over time may indicate that patient status is
deteriorating and additional assessment is warranted. Reference Theory of
Operations, p. ADD-25,for the theory behind how the Respiration Rate param-
eter works. Reference Monitoring System Constraints, p. ADD-22, for informa-
tion on related alarm limits.
Note:
Respiration rate values are updated every five seconds. Users should be aware that the
reported respiration rate represents an average over a period of time and does not
necessarily represent the instantaneous respiration rate. Low and high respiration 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, confirm the following:
•The monitoring system is powered on, has successfully completed its power-on
self-test, and has the Respiration Rate parameter enabled. Contact a qualified
service technician to have the monitoring system upgraded if the Respiration Rate
parameter does not appear on the screen.
Note: If the Respiration Rate parameter is enabled and a parameter module that
does not support Respiration Rate is subsequently installed in the monitoring
system, the following error is displayed at power-up:
“Parameter module does not support RR. Replace with compatible parameter
module or deactivate RR in Service Mode.”
•The monitoring system is connected to power or the battery is fully charged.
•An interface cable is connected to the monitoring system sensor port as described
in the Operator’s Manual.
•A respiratory sensor is connected to the interface cable and correctly applied to
the patient as described in the Instructions for Use. Reference Required Pulse
Oximetry Sensor Usage, p. ADD-14 for additional information.

Nellcor™ Respiration Rate
ADD-14 Operator’s Manual Addendum
1.4.2 Required Pulse Oximetry Sensor Usage
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 SpO2and 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 respiratory sensor, the monitoring system will post both
SpO2and pulse rate and the message CALCULATING until enough data are
available to post respiration rate. The monitoring system posts a status
message for instances where it is unable calculate a respiration rate. If such is
the case, examine all possible performance considerations. Reference Perfor-
mance Considerations, p. ADD-22.
Figure1-11.RR field with Calculating Message

Operation
Operator’s Manual Addendum ADD-15
1.4.3 Respiration Rate Safety Information
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
1. Press EXIT, then press HELP.
2. Select RR Safety Information from the Help options, and review the safety infor-
mation.
3. Press Exit.
1.4.4 Menu Options
Most menu options remain the same as those listed in the Operator’s Manual.
Menu options 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 limits. An alarm is indicated each time a patient’s respiration
rate violates either limit.
By default, the upper alarm limit is 28 breaths per minute, and the lower alarm
limit is 8 breaths per minute. If changing these values, be sure to observe all
warnings and cautions presented in the Operator’s Manual regarding setting
appropriate alarm limits.
Note:
The ability for users to adjust alarm limit settings can be enabled or disabled by
qualified service personnel as described in the Service Manual.