Covidien Nellcor Series Installation and operating instructions

Operator’s Manual Addendum
Nellcor™
Bedside Respiratory Patient Monitoring System
Respiration Rate Version 1.0

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The information contained in this manual is the sole property of Covidien and may not be
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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.

i
Table of Contents
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.1 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2.3 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.3 Updated Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.4.1 Required Pulse Oximetry Sensor Usage . . . . . . . . . . . . . . . . . . 8
1.4.2 Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4.3 Respiration Rate Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.4 Additional Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4.5 Additional Respiration Rate Parameter . . . . . . . . . . . . . . . . . . 12
1.4.6 Menu Options and Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.5 Additional Data Output Fields . . . . . . . . . . . . . . . . . . . . . . 15
1.5.1 Real-time Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.5.2 Historical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.6 Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . 19
1.6.1 Monitoring System Constraints . . . . . . . . . . . . . . . . . . . . . . . 19
1.6.2 Nellcor™ Sensor Performance Considerations . . . . . . . . . . . . 19
1.6.3 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1.7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
1.8 Additional Nellcor™ Pulse Oximetry Sensor . . . . . . . . . . 24
1.9 Theory of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.10 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
1.11 Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
1.11.1 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
1.11.2 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
1.11.3 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
1.11.4 Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
1.11.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

ii

ADD-1
1 Nellcor™ Respiration Rate
1.1 Overview
This Operator’s Manual addendum describes the operation of the
Nellcor™ Respiration Rate Version 1.0 parameter when used with the
Nellcor™ Bedside Respiratory Patient Monitoring System.
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™ Respiratory
Sensor. The parameter provides alarms for high and low respiration rate. The
upper threshold is fixed at 28 breaths per minute, while the lower threshold is
fixed at 8 breaths per minute.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 instruc-
tions, other than those listed here, remain the same as those listed in the
Opera-
tor’s Manual . This addendum only contains information relevant to respiration rate
parameter usage.
Version 1.0

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 and intended use statements,
New monitoring screen fields included in Operation section.
3 Installation Refer to separate Activation Instructions
4 Operation Additional monitoring screen views, additional alarm condi-
tions, additional sensor type
5 Product Data Output Additional data fields in data output
6 Performance Considerations Additional sensor and patient condition 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

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 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. 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:
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
patients with significantly irregular cardiac rhythms have not been
established. Use an alternate means of monitoring ventilatory status for
patients with significant cardiac dysrhythmia.
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.

Introduction
Operator’s Manual Addendum ADD-5
Caution:
Safety and effectiveness of respiration rate in patients on mechanical
ventilation have not been established.
Caution:
Respiration rate may present inaccurate respiration rate values when
respiration rate exceeds 50% of heart rate. This situation, though rare, may
occur under conditions including, but not limited to, any of the following:
patients with high respiration rate and low heart rate, patients taking beta
blockers, or patients with specific medical conditions such as sick sinus
syndrome.
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.
1.2.2 Related Documents
Documentation is available online at www.covidien.com.
•The Nellcor™ Bedside Respiratory Patient Monitoring System Operator’s
Manual — Provides basic information or operating the monitoring system and
troubleshooting errors or malfunctions. Before using the monitoring system, thor-
oughly read this manual.
•Pulse Oximetry Sensor Instructions for Use — Guides sensor selection and
usage. Before attaching any of the various Covidien-approved Nellcor™ sensors
to the monitoring system, refer to their Instructions for Use.
•Saturation Accuracy Grid — Provides sensor-specific guidance related to
desired SpO2saturation accuracy measurements. Available online at
www.covidien.com.
•The Nellcor™ Bedside Respiratory Patient Monitoring System Service
Manual — Provides information to qualified service technicians for use when ser-
vicing the monitoring system.

Nellcor™ Respiration Rate
ADD-6 Operator’s Manual Addendum
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.
1.3 Product Overview
1.3.1 Product Description
The Covidien Nellcor™ Respiration Rate Version 1.0 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 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 intend-
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
ed 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 Respiration Rate parameter, when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ 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 Screen
The front panel, back panel, and parameter module remain the same as those
listed in the Operator’s Manual. The user interface components remain the
same as those listed in the Operator’s Manual, with the addition of the new
respiration rate field at the lower right of the monitoring screen.
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
fixed at 28 and 8, respectively.
Figure1-1.Respiration Rate Fields
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

Nellcor™ Respiration Rate
ADD-8 Operator’s Manual Addendum
1.4 Operation
1.4.1 Required Pulse Oximetry Sensor Usage
To obtain respiration rate, caregivers must use a Nellcor™ Respiratory Sensor.
If caregivers use alternate sensors, listed in the Operator’s Manual, the moni-
toring system continues to post both SpO2and pulse rate data, with the user
message, NON-RR SENSOR CONNECTED, and dashes in the RR field.
Figure1-2.RR field with Non-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 UNABLE TO
CALCULATE 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-19.
Figure1-3.RR field with Calculating Message
The current respiration rate value (in breaths per minute) is shown as a large
white numeral on the right side of the display. Respiration rate is also shown
in a trend view with rate values on the vertical axis and time (in 24-hour format)

Operation
Operator’s Manual Addendum ADD-9
on the horizontal axis. The trend view shows the patient’s respiration rate over
time, with the most current reading on the right.
1.4.2 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.
•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. The monitoring system reports
the appropriate sensor type in the message field when it detects the sensor.
Figure1-4.Sample Sensor Type Message

Nellcor™ Respiration Rate
ADD-10 Operator’s Manual Addendum
1.4.3 Respiration Rate Views
Figure1-5.Pleth View with Respiration Rate
Figure1-6.Trend View with Respiration Rate

Operation
Operator’s Manual Addendum ADD-11
Figure1-7.Combined View with Respiration Rate
Figure1-8.Blip View with Respiration Rate
1.4.4 Additional Alarm Messages
Existing alarm behaviors remain the same as those listed in the Operator’s Manual .
Several new alarms accompany the respiration rate parameter. When an alarm is
active, the value in that field turns black on a yellow background. Reference
Trou-
bleshooting
, p. ADD-23.

Nellcor™ Respiration Rate
ADD-12 Operator’s Manual Addendum
Figure1-9.Sample Alarm Condition
1.4.5 Additional Respiration Rate Parameter
WARNING:
Use only Nellcor-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.
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.
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-

Operation
Operator’s Manual Addendum ADD-13
cant changes in respiration rate over time may indicate that patient status is
deteriorating and additional assessment is warranted. Reference the Reference
Theory of Operations, p. ADD-24,for the theory behind how the Respiration
Rate parameter works. Reference Monitoring System Constraints, p. ADD-19,
for information on related alarm limits.
Note:
Respiration Rate values are calculated 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.
1.4.6 Menu Options and Defaults
Menu options and default settings remain the same as those listed in the Oper-
ator’s Manual. The respiration rate alarm limit thresholds are fixed; they are not
user-selectable.
In addition to the new respiration rate field on all monitoring screens, trend
information also includes respiration rate data.
1. The MONITORING HISTORY trend data also includes respiration rate historical
trends below the SpO2and pulse rate historical trends.
Figure1-10.MONITORING HISTORY Screen

Nellcor™ Respiration Rate
ADD-14 Operator’s Manual Addendum
2. The trend data pop-up window also includes respiration rate data whenever the
Respiration Rate parameter is enabled.
Figure1-11.MONITORING HISTORY Pop-up
3. Trend data types in the SELECT TRENDS option also include variations of the three
main variables of SpO2, pulse, and respiration rate.
a. SpO2only
b. Pulse only
c. Respiration rate only
d. SpO2and pulse
e. SpO2and respiration rate
f. Pulse and respiration rate
g. SpO2, pulse, and respiration rate

Additional Data Output Fields
Operator’s Manual Addendum ADD-15
Figure1-12.Initial Select Trends Screen
1.5 Additional Data Output Fields
The following trend data fields are available to users after activating respiration
rate. Not all remote monitoring software will report respiration rate data.
•SpO2(Saturation) trend data
•Pulse rate (BPM) trend data
•Pulse amplitude trend data
•Respiration rate trend data
1.5.1 Real-time Trend Data
Users may view the trend display at any time. Users may choose to view trend
data in a tabular or graphical format.
Graphical Trend View
The graphical trend view provides users with 15 minutes to 48 hours of continuous
trend data. Status codes remain the same as those listed in the
Operator’s Manual .

Nellcor™ Respiration Rate
ADD-16 Operator’s Manual Addendum
Figure1-13.Graphical trend data monitoring history components
Tabular Trend View
The tabular trend view provides users with data from 20 to 40 seconds of con-
tinuous trend data in a tabular format. Status codes are constrained to five
types and are the same as those listed in the Operator’s Manual.
1 Graph x-axis contains time divisions, depending on specified time scale
2 Yellow triangle icon for period of SPD alert
3 Green pulse trend data for specified time scale
4 Graph y-axis contains signal amplitude values
5 Trend scale button for adjusting time scale to view more or less data
6 Dashed horizontal yellow lines for upper and lower thresholds
7 Yellow circle icon for period of SatSeconds alarm
8 Cyan SpO2 trend data for specified time scale
9 Yellow fill for period of limit threshold violation
10 White respiration rate data for specified time scale
11 Scroll bar for access to additional trend data