Rev E ExSpiron 1xi Pediatrics Electronic User Manual

Respiratory Motion , Inc.
(781) 373-1636
80 Coolidge Hill Rd. info@respiratorymotion.com
Watertown, MA 02472 www.respiratorymotion.com
General Warning:
DO NOT use the ExSpiron 1Xi monitor:

• for any purpose other than specified in this manual
• if parts are broken or missing
• without reading this user manual
ONLY qualified personnel should use the ExSpiron 1Xi monitor.
The ExSpiron 1Xi monitor is NOT a diagnostic monitor. ExSpiron 1Xi should
be used as an adjunct to other clinical information to determine respiratory
status and appropriate therapy.
Respiratory Motion, Inc. ExSpiron™ 1Xi Page 1 of 63

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Contact Information
Manufactured By
Respiratory Motion, Inc.
80 Coolidge Hill Rd
Watertown, MA 02472 USA
Tel: +1 781-373-1636
+1 781-373-1635
Fax: +1 781-373-1653
www.respiratorymotion.com
Clinical Support:
clinicalsupport@respiratorymotion.com
Technical Support:
techsupport@respiratorymotion.com

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Table of Contents
1 Introduction ...............................................................................................................4
1.1 Intended Use ............................................................................................................4
1.2 Intended Operators ...................................................................................................4
1.3 Contraindications .....................................................................................................4
1.4 Essential Performance..............................................................................................5
2 Safety Measures ........................................................................................................6
2.1 Warnings ..................................................................................................................6
2.2 Cautions ...................................................................................................................6
2.3 Precautions ...............................................................................................................7
2.4 Cleaning and Disinfection .......................................................................................8
2.5 Disposal ...................................................................................................................8
3 Operation ...................................................................................................................9
3.1 Principles of Operation ............................................................................................9
3.2 Description ...............................................................................................................9
3.3 Mounting the ExSpiron 1Xi ...................................................................................10
3.4 Connecting the ExSpiron 1Xi Patient Cable..........................................................10
3.5 ExSpiron 1Xi Printed PadSet Electrode Placement ...............................................11
4 User Interface ..........................................................................................................12
4.1 Abbreviations .........................................................................................................12
4.2 Welcome Screen ....................................................................................................12
4.3 Patient Selection Pop-up ........................................................................................13
4.4 Trace Screen ..........................................................................................................15
4.5 Basic Monitoring ...................................................................................................16
4.6 Percent Baseline Screen .........................................................................................19
4.7 Calibration/Sync Pop-up ........................................................................................20
4.8 Volume Synchronization Screen ...........................................................................21
4.9 History Pop-up .......................................................................................................23
4.10 Patient Management Pop-up ..................................................................................27
4.11 Settings Pop-up ......................................................................................................28
5 Clinical Procedure ..................................................................................................32
5.1 Signal Quality ........................................................................................................32
5.2 Understanding ExSpiron 1Xi Readings .................................................................32
6 Alarm System ..........................................................................................................35
6.1 Physiological Alarm Conditions ............................................................................35
6.2 Technical Alarm Conditions ..................................................................................36
6.3 Setting Alarm Limits and MV Marker ..................................................................38
6.4 Alarm Limits on the Monitoring Screens ..............................................................39
6.5 Alarm Signals ........................................................................................................40
6.6 Pausing Alarms ......................................................................................................42
6.7 Verifying the Functionality of the Alarm System .................................................42
7 IntelliVue Communication .....................................................................................43
7.1 Connecting with IntelliBridge Components ..........................................................43
7.2 Connecting with VueLink Components ................................................................44
7.3 Transmitted Data and Alarms ................................................................................45
7.4 Operation ...............................................................................................................45
8 Nurse Call Communication....................................................................................46
8.1 Installation .............................................................................................................46
8.2 Operation ...............................................................................................................46

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8.3 Interconnection Diagram .......................................................................................47
Appendix A: Accessories .................................................................................................48
Appendix B: Specifications and EMC Declarations .....................................................48
Appendix C: Clinical Studies to Determine Accuracy .................................................53
ExSpiron 1Xi – Wright comparison (Volume Synchronization)....................................53
Wright spirometer – Morgan SpiroAir LT diagnostic spirometer study ........................55
ExSpiron 1Xi with Basic Monitoring – Wright comparison ..........................................56
Appendix D: Support.......................................................................................................60
Product Support ..............................................................................................................60
Phone Support .................................................................................................................60
Training ...........................................................................................................................60
Ordering Accessories ......................................................................................................60
Exchange Repair .............................................................................................................60
Appendix E: Symbols ......................................................................................................61
Appendix F: References ..................................................................................................62
1 Introduction
1.1 Intended Use
ExSpiron 1Xi is indicated for use by healthcare professionals in Healthcare facilities, such as post-
operative care and critical care units, to monitor breathing in patients at least one year of age.
ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an
approximate value of:
* Minute Ventilation (MV)
* Tidal volume (TV)
* Respiratory rate (RR)
ExSpiron 1Xi measurements are used as an adjunct to other clinical information.
NOTE: United States regulation restricts this device to sale by or on the order of licensed medical
practitioners.
1.2 Intended Operators
ExSpiron 1Xi is intended to be operated by trained technicians and clinical professionals. This manual
serves as a training document. A training session can be scheduled by calling +1 781-373-1636.
The configuration screens on ExSpiron 1Xi are designed to be clearly legible to a user 1 meter away from
the monitor. Measurements displayed on the screen and alarm signals are designed to be perceived by
operators within 3 meters of the ExSpiron 1Xi.
1.3 Contraindications
There are no known contraindications for the ExSpiron 1Xi.

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1.4 Essential Performance
Essential performance is performance of a clinical function, other than that related to basic safety, where
loss or degradation beyond the limits specified by the Manufacturer results in an unacceptable risk. The
ExSpiron 1Xi does not have any essential performance.

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2 Safety Measures
2.1 Warnings
WARNING: Electric shock hazard. The ExSpiron 1Xi monitor is to be serviced only by Respiratory
Motion personnel, their designees, or qualified service engineers. There are no user-serviceable parts
inside. The battery cannot be changed by the user. Only connect to supply mains with protective earth.
WARNING: Use only the ExSpiron 1Xi power cable.
WARNING: Do not connect the ExSpiron 1Xi to any other equipment or network/data couplings except
as described in this manual.
WARNING: Use of the ExSpiron 1Xi adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified in this user manual
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING: Portable RF communications equipment should be used no closer than 30 cm to any part of
the ExSpiron 1Xi, including cables. Otherwise, degradation of the performance of this equipment could
result.
WARNING: Do not position the ExSpiron 1Xi such that it is difficult to unplug the power cable.
2.2 Cautions
CAUTION: ExSpiron 1Xi disposable electrode PadSets are designed for single use only and should not
be reused. Reuse may interfere with monitor function. An electrode PadSet should not be used for more
than 24 hours. Dispose of PadSets per the healthcare facility policy.
CAUTION: Use only ExSpiron 1Xi electrode PadSets with the ExSpiron 1Xi monitor. Accuracy of the
device cannot be assured unless ExSpiron 1Xi PadSets are used.
CAUTION: Other devices, such as bioimpedance monitors, fluid warmers, and HF surgical equipment,
may cause functional interference with the ExSpiron 1Xi. In order to avoid or minimize such interference,
ensure that the ExSpiron 1Xi is connected to hospital-grade electrical outlets. When using the ExSpiron
1Xi with other devices, confirm that all systems are operating properly.
CAUTION: The emissions characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). Otherwise, this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.
CAUTION: Do not mount or store the ExSpiron 1Xi monitor under an IV bag or other liquids. Fluid
leaking onto the monitor may interfere with monitor function and may create an electric shock hazard.
CAUTION: Before attaching the ExSpiron 1Xi monitor to a medical monitoring pole (IV), ensure that the
pole is specified to carry the weight of the ExSpiron 1Xi monitor.
CAUTION: The accuracy of ExSpiron 1Xi volume measurements has not been confirmed at very high (>
30 breaths per minute) or very low (< 5 breaths per minute) respiratory rates. If a patient has a very high or
very low respiratory rate, confirm respiratory status with other clinical information sources.

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CAUTION: The accuracy of ExSpiron 1Xi measurements has not been confirmed for patients with a
Body Mass Index (BMI) over 43 If a patient has a BMI outside of this range, confirm respiratory status
with other clinical information sources.
CAUTION: The accuracy of ExSpiron 1Xi measurements has not been confirmed at very low heart rates
(< 40 beats per minute). If a patient has a very low heart rate, confirm respiratory status with other clinical
information sources. For patients whose heart rates are low or whose heart rates are to be slowed
intentionally, refer to section 4.11 for instructions on how to use the low heart rate settings.
CAUTION: A very large change in patient hydration may affect the measurement. If a patient experiences
a large change in hydration, confirm respiratory status with other clinical information sources.
CAUTION: The ExSpiron 1Xi is indicated for patients with no demonstrable unilateral pulmonary
abnormality. If there is a suspicion of significant unilateral abnormality, other clinical information sources
such as x-ray or physical examination should be used to assess bilateral symmetry vs unilateral
abnormality.
CAUTION: The ExSpiron 1Xi is not defibrillator-proof. Disconnect the ExSpiron 1Xi from the patient
prior to defibrillation.
CAUTION: Do not autoclave, gas-sterilize, or immerse any portion of the ExSpiron 1Xi monitor.
CAUTION: The patient cable should not be sterilized. If the cable cannot be adequately cleaned, dispose
of the cable per the healthcare facility policy, and use a new patient cable.
CAUTION: This device has not been tested under MRI conditions.
CAUTION: Basic Monitoring functionality is not available for Pediatric Patients.
CAUTION: When selecting Pediatric Mode ensure the following patient information is correct.
Height: 20 – 50 inches
Weight: 18 – 77 lb
Age: 1 – 20 years
2.3 Precautions
The ExSpiron 1Xi monitor should not be used as the sole basis for diagnosis or therapy. Healthcare
professionals should use ExSpiron 1Xi measurements as an adjunct to other clinical information sources to
help determine respiratory status and appropriate therapy.
The ExSpiron 1Xi monitor should not be used as an apnea monitoring system.
Electrodes should not be applied to impacted skin. Attachment of electrodes to skin that is sensitive may
result in irritation.

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2.4 Cleaning
Clean external surfaces of the ExSpiron 1Xi monitor and patient cable with a cloth dampened with
warm water. Cleaning with 0.5% bleach concentration solution is recommended for the external
surfaces and 70% Isopropyl Alcohol for the Touch Screen.
2.5 Disposal
Dispose of used electrode PadSets per the healthcare facility policy.
At the end of its life, dispose of or recycle the ExSpiron 1Xi monitor per local or national regulations.

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3 Operation
3.1 Principles of Operation
The ExSpiron 1Xi measures bioelectrical impedance, which is the tissue’s opposition to carrying an
alternating electrical current. Impedance measurements correlate with the volume of air in the lungs.
Software algorithms calculate Minute Ventilation, Tidal Volume and Respiratory Rate.
3.2 Description
The system includes:
• ExSpiron 1Xi Respiratory Volume Monitor
• ExSpiron 1Xi Patient Cable
• ExSpiron 1Xi Electrode PadSets
• Medical Grade Power Cord
The power button is on the left side, marked by power symbol (1). To turn the ExSpiron 1Xi on, press the
power button.

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On the rear of the device, there are cable sockets/ports:
• ExSpiron 1Xi Patient Cable Connector (1) - The round socket is intended for the Patient Cable.
The other end of the Patient Cable should be connected to the ExSpiron 1Xi PadSet Electrodes.
• Power Input (2) - Medical Grade Power Input. The monitor can also operate on its rechargeable
internal battery. When the monitor is plugged in, the blue LED Indicator (6) shines.
• USB Port (3) – The USB ports on the ExSpiron 1Xi are intended to be used only with accessories
provided by Respiratory Motion.
1 2
3
3.3 Mounting the ExSpiron 1Xi

Before attaching the ExSpiron 1Xi monitor to a medical monitoring pole (IV), ensure that the pole is
specified to carry the weight of the ExSpiron 1Xi monitor. To mount the ExSpiron 1Xi on an IV pole,
place the Pole Clamp (4) onto the pole and tighten using the Knob (5).
3.4 Connecting the ExSpiron 1Xi Patient Cable
The ExSpiron 1Xi Patient Cable connects the ExSpiron 1Xi monitor to the ExSpiron 1Xi Printed PadSet.
The round, six-pin connector is keyed to fit the Patient Cable Connector on the rear of the ExSpiron 1Xi
monitor. The ExSpiron 1Xi Printed PadSet connector can be inserted flat side down into the rectangular
connector on the other end of the ExSpiron 1Xi Patient Cable.

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3.5 ExSpiron 1Xi Printed PadSet Electrode Placement
Proper PadSet placement is shown in Figure 3.5. There are three electrode pads, designated A, B and C.
Perform routine skin preparation following standard hospital protocol before electrode PadSet placement.
Thoroughly clean the patient’s skin. Failure to do so could interfere with the ExSpiron 1Xi readings.
Apply only to clean, dry, intact skin.
Open pouch by tearing along edge at notch. Remove PadSet and carrier from bag.
Carefully separate PadSet from carrier.
Remove paper liner from back of electrode A, labeled “Head.” Place top of electrode on sternal notch,
with electrodes aligned along the sternum as shown. Press electrode firmly.
Remove paper liner from back of electrode B, labeled “Xiphoid.” Extend electrode down to its proper
location on xiphoid process as shown. Press electrode firmly.
Remove paper liner from back of electrode C, labeled “Side.” Extend electrode to the right. Align the
center of the electrode on the mid-axillary line, horizontally in line with the xiphoid.
For smaller patients, the PadSet may be folded and taped to the chest for patient comfort or use the
Pediatric PadSet.
Connect Patient Cable to PadSet.
(Figure 3.5 - Standard Electrode Placement Diagram)

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4 User Interface
4.1 Abbreviations
• MRN: Medical Record Number
• TV: Tidal Volume
• MV: Minute Ventilation
• RR: Respiratory Rate
4.2 Welcome Screen
When the ExSpiron 1Xi user interface is launched, the initial Welcome screen presents main menu options
on the navigation bar on the right. The menu system is navigated using touch screen controls. Current
battery status is indicated in the upper right-hand corner of the welcome screen (5).
To Begin a Patient Session:
Open the Patient Selection Pop-up (4.3) by pressing Select Patient (1).
To Manage Saved Patient Information:
Open the Patient Management Pop-up (4.10) by pressing Manage Patients (2).
To Change Settings:
Open the Settings Pop-up (4.11) by pressing Settings (3).
To Power Off:
Turn off the ExSpiron 1Xi monitor by pressing Power Off (4).

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5 6
(Figure 4.2 - Welcome Screen)
Label Button/Field Function

1 Select Patient Opens the patient selection Pop-up to start a patient session.
2 Manage Patients Allows user to manage saved patient information.
3 Settings Allows user to change the monitoring time interval and units.
4 Power Off Powers off the ExSpiron 1Xi.
5 Battery Indicator Shows the remaining battery life of the ExSpiron 1Xi.
6 Information icon Opens the “About” panel which displays the software revision.
4.3 Patient Selection Pop-up
The Patient Selection Pop-up allows the user to select a saved patient or enter new patient information.
To Choose an Existing Patient:
In the upper left search bar, the patient list can be filtered by: first name, last name, or Medical Record
Number (MRN). The patient can then be selected from the patient list below the search bar (1). Once the
existing patient has been selected, the patient’s information is displayed on the right side of the screen. If
the information is correct, press the Confirm button (6) to advance to the Trace Screen (4.4). If the
information is incorrect, edit the information by pressing the Edit button (4) to allow the fields to be edited.
Enter the correct information and then press the Confirm button (6) to advance to the Trace Screen (4.4).

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To Add a New Patient:
To add a new patient, press the New Patient button (5). When all patient information has been entered,
press the Confirm button (6) to advance to the Trace Screen (4.4).
1
3
(Figure 4.3- Patient Selection Pop-up)

1 Saved Patients Selects past patients in order to edit patient info, or begin a patient session.
2 Cancel Closes the Patient Selection Pop-up.
3 Discard Edits Clears all patient fields.
4 Edit Allows user make changes in patient information.
5 New Patient Enters new patients in order to begin monitoring.
6 Confirm Brings user to the Trace screen.
Message Boxes:
Height, weight, gender, and Adult/Pediatrics mode are required fields for all patients. If Pediatrics mode is
selected, date of birth is required. If any of the required fields is empty and the Confirm button (5) is
pressed, a message box will appear saying: “Please enter the patient [height/weight/gender/date of birth].”
The patient height and weight are checked to ensure that they are within normal ranges for the human
pediatric or adult populations. If either field contains a potentially abnormal value and the Confirm button
(6) is pressed, a message box will appear requesting confirmation of data entry.
If Pediatrics mode is selected, the patient date of birth is checked to ensure patient age is between 1 and 21
years. If the age is outside of this range and the Confirm button (6) is pressed, a message box will appear
requesting confirmation of data entry.

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4.4 Trace Screen
After the patient information has been confirmed, the user is brought to the Trace screen. The respiratory
Trace is displayed so users can confirm that the electrodes are connected correctly (2). The buttons at the
right allow the user to navigate away from the Trace screen. The “Start Basic Monitoring” (3) button
allows users to begin a monitoring session without patient-specific calibration. The “Start With Vol Sync”
(5) button allows users to begin a monitoring session with patient-specific calibration.
To Begin a Monitoring Session (only available in adult mode):
Press the “Start Basic Monitoring” button (3) to launch the Basic Monitoring Screen (4.5). Before the
session begins, the Set Limits popup will appear to enable you to confirm the alarm limits. For more
information on the alarm settings see section 6.
To Begin a Percent Baseline Session:
Press the “Start With % Baseline” button (4) to launch the Percent Baseline Screen (4.6). Before the
To Begin a Volume Synchronization Session:
Press the “Start With Vol Sync” button (5) to launch the Calibration/Sync Pop up Screen (4.7). Before the
To Close the Patient:
Press the Close Patient button (8) to return to the Welcome Screen (4.2).

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1
2 3
(Figure 4.4 - Trace screen)

1 Patient ID Shows the patient’s name, MRN, and adult or pediatric operating mode,
noted by an A or P.
2 Respiratory Curve Displays the real-time respiratory curve.
3 Start Basic Brings user to the Basic Monitoring screen.
Monitoring
4 Start With Brings the user to the Percent Baseline screen.
% Baseline
5 Start With Brings the user to the Calibration popup to begin Volume
Vol Sync Synchronization.
6 History Allows the user to view the patient’s ExSpiron 1Xi history.
7 Settings Allows user to change the monitoring time interval and units of
measurement.
8 Close Patient Brings user back to Welcome screen.
4.5 Basic Monitoring
The Basic Monitoring screen displays the real time respiratory trace (2), respiratory parameters (4), and
respiratory trends (5). The main display can be cycled through different views by pressing the MV trend

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(5) or the respiratory trace (2). To exit the session at any time, press the End Monitoring button (7). Note
on the MV trend there is a horizontal white line. This is a marker, which indicates the patient’s 100% MV
predicted value.
There is no need to calibrate or establish a baseline during a Basic Monitoring session. The ExSpiron 1Xi
can automatically measure respiratory parameters for patients based upon their input data when in a Basic
Monitoring session.
To Set Alarm Limits:
To set alarm limits for MV, TV, or RR, press the triangular alarm symbol (3) to the right of any of the
respiratory parameters. This opens the Alarm Limits Pop-up (6.3b). Once alarms are configured for the
parameter, the alarm limits are displayed below this symbol.
To View Current Patient History:
To view the monitoring history of the current patient, press the History button (8). This opens the History
Pop-up (4.9) and allows reports to be saved.
Settings:
To Pause Alarm Signals:
To pause the alarm signals for 2 minutes, press Pause Alarms (10). This will pause both selected and
technical alarms. Alarm signals will resume after 120 seconds.
To End a Monitoring Session:
To end a monitoring session, press End Monitoring (7). This takes you back to the Trace Screen (4.4).
From there, the patient can be closed out using the Close Patient button; this navigates back to the
Welcome screen (4.2).

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1 6
2 7
5
8
3
4
9
10
(Figure 4.5 – Basic Monitoring screen)

1 Patient ID Shows the patient’s name, MRN, and adult or pediatric operating
mode, noted by an A or P. (Note: Basic Monitoring on the
ExSpiron 1Xi is only available in adult mode).
2 Respiratory Curve Displays real-time respiratory curve.
3 Alarm Symbol Launches the Set Limits Pop-up. Alarm limits are displayed below
this symbol.
4 Respiratory Parameters Displays a 30 second average of MV, TV and RR.
5 Respiratory Trends Displays the trends of MV, TV, and RR.
6 Snapshot Button Exports a screenshot image to a USB drive.
7 End Monitoring Closes the current session and returns to the Trace screen.
8 History Allows the user to view the patient’s monitoring history.
measurement.
10 Pause Alarms Pauses or un-pauses alarm signals.

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4.6 Percent Baseline Screen
The Percent Baseline screen functions much the same as the Basic Monitoring screen (4.5). The only
difference is that values for MV and TV are displayed as a percentage of baseline. A baseline is established
based on the first 30 seconds of respiratory data. To establish a baseline, it is important that the patient is
breathing without disturbance. At the end of the 30 second period, the baseline values are checked against
the predicted metrics for the patient’s height, weight, and gender. In Adult mode if the acquired baseline is
out of an expected range, the user will be able to select “Recalculate Baseline,” “Use Previous Baseline” or
either “Use High Baseline” or “Use Low Baseline.” If the user elects to accept a baseline that is out-of-
range, a message of “High Baseline” or “Low Baseline’ is displayed on the device. In Pediatric mode the
acquired baseline will always be used.
CAUTION: If an out-of-range baseline is used for a Percent Baseline session, consider adjusting the alarm
limits accordingly.
The baseline can be recalculated anytime using the Recalculate Baseline button (8)
When finished monitoring the patient, press the End Monitoring button (7). Patient History (9) and
Settings (10) can both be accessed from the navigation bar on the right.
1 6
2 7
3 9
5
10
11
(Figure 4.6- Percent Baseline Screen)

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mode.
3 Alarm Symbol Launches the Set Limits Pop-up
4 Respiratory Parameters Displays the numeric value of MV, TV and RR as a percent of
baseline.
7 End Monitoring Closes the current session and returns to the Trace screen.
8 Recalculate Baseline Recalculates the patient baseline
10 Settings Allows user to change the time interval settings and default units of
measurement.
11 Pause Alarms Pauses or un-pauses alarm signals
4.7 Calibration/Sync Pop-up
The Calibration/Sync Pop-up is used to record and input calibration data for the patient in a Volume
Synchronization (Vol Sync) session. If the patient has a previous calibration saved, it is displayed on the
left of the screen (1).
4
1 6
2
7
(Figure 4.57 – Calibration Pop-up)
8

1 Load Previous Displays the date and time of previous calibrations for the current patient.
Calibration
2 Calibration Trace Displays the patient’s impedance trace during data acquisition.
3 Metrics measured Allows entry of external device metrics.
with external device
4 Start Begins collecting calibration data.
5 Stop Stops collecting calibration data.
6 Cancel Brings user back to Trace screen.
7 Apply Calibration Brings user to Volume Synchronization screen; remains disabled until
calibration has completed.
8 Predicted MV Displays predicted MV based on height, weight, and gender

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To Use a Previously Saved Calibration:
If the currently selected patient has a previous calibration saved, the date and time of the calibration is
displayed under the Load Previous Calibration option (1). To use this previous calibration, select Load
Previous Calibration then press Apply Calibration (7).
To Establish a New Calibration:
Select the New Calibration option. When ready, press the Start button (4) to begin recording data. The
respiratory trace will be shown (2). During this time, measure the patient’s respiratory data with an
external spirometer or ventilator. After 30-60 seconds of data collection, press the Stop button (5). Select
either Tidal Volume or Minute Ventilation and enter the data acquired from the spirometer or ventilator in
the appropriate field (3). The MV of the calibration run will appear on the Volume Synchronization screen
as a solid white line on the MV trend. If TV is used to calibrate, the baseline is extrapolated from the TV
and RR of the calibration run.
Press Apply Calibration (7) to launch the Volume Synchronization screen (4.8). You will be asked to
confirm alarm settings before starting a session. For more information on alarm settings see section 6.
Press Cancel (6) to return to the Trace screen (4.4).
Message Boxes:
If the Stop button (5) is pressed after a calibration run of less than 10 seconds, the following message box
will appear: “Calibration run is too short! Please try again.” An automatic calibration check is performed
after the Apply Calibration (7) button is pressed. If the calibration check fails, the following message will
appear: “Calibration check failed! Measure calibration volumes again.”
4.8 Volume Synchronization Screen
The Volume Synchronization (Vol Sync) screen displays the real time respiratory trace (2), respiratory
parameters (4), and respiratory trends (5). The main display can be cycled through different views by
pressing the MV trend (5) or the respiratory trace (2). To exit the session at any time, press the End
Monitoring button (6). Note on the MV trend there is a horizontal white line. This is a marker that
indicates the MV predicted value for the patient.
To Recalibrate:
The ExSpiron 1Xi can be recalibrated at any time by pressing the Recalibrate button (8). This opens the
Calibration Pop-up (4.7).
To View Current Patient History:
To view the monitoring history of the current patient, press the history button (9). This opens the History
Pop-up (4.9) and allows reports to be saved.

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Settings:
To Set Alarm Limits:
To set alarm limits for MV, TV, or RR, press the triangular alarm symbol (3) to the right of any of the
respiratory parameters. This opens the Alarm Limits Pop-up (6.3b). Once an alarm is configured for the
parameter, the alarm limits are displayed below this symbol.
To Pause Alarm Signals:
To pause the alarm signals for 2 minutes, press Pause Alarms (11). Alarm signals will resume after 120
seconds.
To End a Monitoring Session:
To end a monitoring session, press End Session (7). This takes you back to the Trace Screen (4.4). From
there, the patient can be closed out using the Close Patient button; this navigates back to the Welcome
screen (4.2).
1 6
2 7
5 9
3
10
4
11
(Figure 4.8 – Volume Synchronization Screen)

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mode, noted by an A or P.
3 Alarm Symbol Launches the Set Limits Pop-up. Alarm limits are displayed below
this symbol.
4 Respiratory Parameters Displays a 30 second average of MV, TV and RR.
7 End Session Closes the current session and returns to the Trace screen.
8 Recalibrate Allows a new calibration to be recorded.
measurement.
11 Pause Alarms Pauses or un-pauses alarm signals.
4.9 History Pop-up

The History Pop-up displays up to seven days of the current patient’s monitoring history. The time period
displayed is customizable through the zoom bar at the top of the screen (1). Sliding the ends of the zoom
bar shortens or lengthens the amount of time displayed in the Trends. Sliding the bar back and forth allows
the user to move forward and backward through the patient’s history. The Trend tab (2) displays the MV,
TV, and RR trends over a specified time. The Values tab (3) displays numerical readouts of MV, TV, and
RR at a customizable time interval.
4.9.1 Trend Tab

To Save a Report of the Patient Data:
Insert a USB storage device into the back of the ExSpiron 1Xi and press Save Report (4).

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7
2 3 8 1
(Figure 4.9.1 - History Trend)

1 Zoom Bar Adjusts displayed time period.
2 Trend Tab Displays respiratory trends in graphical form.
3 Values Tab Displays respiratory trends as a table.
4 Save Report Saves a PDF report to a USB device.
5 Close Closes the History Pop-up.
6 Respiratory Trends Displays patient trend data.
7 Patient Information Displays the current patient’s information.
8 Alarms Tab Displays log of Alarms

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4.9.2 Values Tab
8
1
2 3 9
5
6
(Figure 4.9.2 - Values)

4 Save Report Saves patient data to a USB device.
6 Report Opens a pull-down menu to change the time interval for the Trends Table.
Frequency
7 Trends Table Displays patient trend data.
8 Patient Displays the current patient’s information.
Information

P/N 10483 Rev E
8
2 1
3 4
7
2
(Figure 4.9.3 - Alarms)

5 Save Report Saves patient data to a USB device.
7 Alarms Table Displays patient alarm data.
8 Patient Displays the current patient’s information
Information

P/N 10483 Rev E
4.10 Patient Management Pop-up
The Patient Management Pop-up allows the user to view and edit the patient information saved on the
device. Patients can be searched for by first name, last name, or MRN in the search field (1). When
selected, the patient information can be edited by pressing the Edit button (4). The selected patient can be
deleted by pressing the Delete button (5). Press the Close button (6) to return to the previous screen.
6
1
5
2
(Figure 4.10 - Patient Management Pop-up)

1 Search for patient Type in the patient name or MRN to locate patients for editing or
deletion.
2 Selected Patient Click a patient record in the list to select it for editing or deletion.
3 New Allows the user to create a new patient.
4 Edit Allows the user to edit the selected patient’s information.
5 Delete Removes patient from database along with monitoring history.
6 Close Returns user to welcome screen.

P/N 10483 Rev E
4.11 Settings Pop-up
The Settings Pop-up gives the user the option to change default time intervals and measurement units. In
the Default Tab (4.11.1), use the buttons to select the default units. In the Displayed Range Tab (4.11.2),
use the pull-down menus to change the display ranges for the trace and various metrics. Press the OK
button (5) to save settings and close the Settings Pop-up.
The Advanced Tab (4.11.3) allows the user to configure the MV/TV/RR Alarm Delay, select a No Breath
Detected Pause time, and change the Respiratory Rate/Heart Rate cutoff point for applications with very
low heart rates. The Respiratory Rate/Heart Rate cutoff point is only available once a patient is selected.
Any custom cutoff will be cleared when the current patient is closed.
4.11.1 Defaults Tab
(Figure 4.11.1 – Defaults Tab)

1 Minute Ventilation Changes units of MV measurement.
2 Tidal Volume Changes units of TV measurement.
3 Weight Changes units of weight.
4 Height Changes units of height.
5 OK Applies settings and returns user to previous screen.
6 Cancel Returns user to previous screen.
7 Operating Mode Changes default Operating Mode.

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4.11.2 Displayed Range Tab
5
7
6
(Figure 4.11.2– Displayed Range Tab)

1 Respiratory Trace Changes Time Interval of respiratory trace.
2 Metrics Time Interval Changes metrics trend Time Interval to 1, 2, 4, or 8 hrs.
3 Tidal Volume Changes the maximum value of the Y axis on the Tidal Volume
trend on the monitoring screens and the History pop-up.
4 Minute Ventilation Changes the maximum value of the Y axis on the Minute
Ventilation trend on the monitoring screens and the History pop-up.
5 Respiratory Rate Changes the maximum value of the Y axis on the Respiratory Rate
trend on the monitoring screens and the History pop-up.
6 MV/TV Trend Changes the maximum value on the Y axis of the MV and TV
trends on the monitoring screens and the History pop-up.
7 OK Applies settings and closes the Settings pop-up.
8 Cancel Closes the Settings pop-up without committing changes

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4.11.3 Advanced Tab
The Advanced Settings Tab can be used to set the Alarm Delay, No Breath Detected Period, set a custom
Respiratory Rate/Heart Rate filter cutoff and disable the “SIGNAL INTERFERENCE” Audible Alarm.
The MV/TV/RR Alarm Delay controls the amount of time that passes before the alarm is signaled. For
example if the Alarm Delay is set to 30 seconds, the metric (MV, TV or RR) has to be outside the range
for 30 consecutive seconds before the alarm will signal. Changes to this setting will be maintained on the
monitor until changed by the user. The initial default value is 30 seconds.
A change in Respiratory Rate/Heart Rate filter cutoff setting is recommended for patients with either a low
heart rate (below 45 BPM) or a high respiratory rate (above 35 BPM).
At low heart rate, setting the custom filter cutoff to 30 BPM enhances the ExSpiron 1Xi’s ability to
differentiate between respiratory signals and low-frequency cardiac noise.
At high respiratory rate, appropriately adjusting the filter cutoff to 50 – 120 BPM enhances the ExSpiron
1Xi’s ability to differentiate between high frequency respiratory signals and cardiac noise.
NOTE: this setting is saved with the patient and reverts to the default 40 BPM cutoff when a new
patient is created.
The No Breath Detected Period enables the user to select a time period in seconds such that whenever the
ExSpiron fails to detect a breath during a time interval greater than or equal to the No Breath Detected
Period, it will sound an alarm within 5 seconds. The selection is 30 sec, 45 sec, 60 sec, 90 sec or 120 sec.
The time should be selected based on a clinical assessment of the patients’ respiratory status. Changes to
this setting will be preserved for the selected patient.
NOTE: this setting is saved with the patient and reverts to the default 30 sec Period when a new
patient is created.
The Disable the “SIGNAL INTERFERENCE” Audible Alarm checkbox enables users to disable this
Audible Alarm for the current Monitoring session. The visual Alarm will still be enabled.
NOTE: this setting applies only for the current Monitoring session and reverts to the enabled setting
when a new Monitoring session is started.

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3
1 5
2
4
(Figure 4.11.3 - Advanced Tab)

1 MV/TV/RR Alarm Delay Changes the Alarm Delay
2 RR-HR Cutoff Changes the setting for RR-HR Cutoff
3 Cancel Closes the Settings pop-up without committing changes
4 OK Applies the settings and closes the Settings pop-up
5 No Breath Detected Period Changes the Period between No Breath Detected and the alarm
6 Disable “SIGNAL Checking this box disables the “SIGNAL INTERFERENCE”
INTERFERENCE” Audible Alarm for the current Monitoring session. Default is
Audible Alarm unchecked.

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5 Clinical Procedure
This flow chart outlines the general procedure for clinical use of the ExSpiron 1Xi.
Apply ExSpiron
Turn on ExSpiron
Padset
Select Patient
or enter New
Patient
Start Volume Start Percent

Synchronization Session Baseline Session
Start Basic
Select Existing Monitoring
Calibration, or Session
Set a Baseline
Perform New
Calibration
Confirm or
set alarm
limits.
End Session,
Every 24 hours,
Close Patient Monitor
replace ExSpiron
and Power Off Patient
Electrode PadSet
the ExSpiron
(Figure 5 – Clinical Procedure)
5.1 Signal Quality

Lack of adequate signal quality can result in a flat line displayed on the screen. Flat lining can be a
result of the following:
- Electrodes that are not in full contact with the patient’s skin. Replace the electrode
PadSet with a new one. Hair and sweat can affect the ability of the electrodes to stick to the
skin. Routine hospital preparation for electrode placement, such as abrasive cleansing or
shaving of the area should be used to avoid issues such as these. Electrodes are to be used no
longer than 24 hours.
- Improper connection between the Electrode PadSet and the Patient Cable. Check lead-
electrode attachment.
- Poor signal quality. Check that electrodes were attached in correct placement.
5.2 Understanding ExSpiron 1Xi Readings

The respiratory parameters displayed on the monitoring screen of the ExSpiron 1Xi represent a 30 second
moving average of the indicated metrics.

P/N 10483 Rev E
Respiratory Rate
Respiratory Rate is the number of breaths per minute. Respiratory Rate can be classified as normal,
abnormally fast (tachypnea), abnormally slow (bradypnea), or nonexistent (apnea).
Tidal Volume
Tidal Volume is the total volume of air displaced between inspiration and expiration for a single
breath.
Minute Ventilation
Minute Ventilation is a measure of the total volume of air displaced in one minute. It can be
calculated as the product of tidal volume and respiratory rate.
Table 5.2 - Normal Ranges of Respiratory Parameters.
Value Normal Range Description

Adult Respiratory Rate 12-18 breaths/min Breaths per minute
(ages 21 and above)
Pediatric Respiratory Rate 12-40 breaths/min Breaths per minute
(ages 1 to 20)
Tidal Volume MV / RR Volume per single breath (usually mL)
Minute Ventilation Dependent on gender, height, and Volume of air exchanged in one minute
weight. See tables below. (usually L)

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(Figure 5.2a– Predicted Minute Ventilation based on Height and Weight – Adult Female)
(Figure 5.2b - Predicted Minute Ventilation based on Height and Weight – Adult Male)

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FEMALE Predicted MV (L/min)
60 152 2.2 2.5 2.7 2.8 3.0 3.2 3.3 3.4 3.6 3.7 3.9 4.1 4.3 4.5 4.7 4.9
58 147 2.2 2.4 2.6 2.8 2.9 3.1 3.2 3.4 3.5 3.6 3.8 4.0 4.2 4.4 4.6 4.8
56 142 2.1 2.3 2.5 2.7 2.9 3.0 3.1 3.3 3.4 3.5 3.7 3.9 4.1 4.3 4.5 4.6
54 137 2.1 2.3 2.5 2.6 2.8 2.9 3.1 3.2 3.3 3.4 3.6 3.8 4.0 4.2 4.4 4.5
52 132 2.0 2.2 2.4 2.6 2.7 2.8 3.0 3.1 3.2 3.3 3.5 3.7 3.9 4.1 4.2 4.4
50 127 2.0 2.2 2.3 2.5 2.6 2.8 2.9 3.0 3.1 3.2 3.4 3.6 3.8 4.0 4.1 4.3
48 122 1.9 2.1 2.3 2.4 2.6 2.7 2.8 2.9 3.0 3.1 3.3 3.5 3.7 3.8 4.0 4.1
Height 46 117 1.8 2.0 2.2 2.3 2.5 2.6 2.7 2.8 2.9 3.0 3.2 3.4 3.6 3.7 3.9 4.0
44 112 1.8 2.0 2.1 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.1 3.3 3.5 3.6 3.8 3.9
42 107 1.7 1.9 2.1 2.2 2.3 2.4 2.5 2.7 2.8 2.8 3.0 3.2 3.3 3.5 3.6 3.8
40 102 1.7 1.8 2.0 2.1 2.2 2.4 2.5 2.6 2.7 2.7 2.9 3.1 3.2 3.4 3.5 3.6
38 97 1.6 1.8 1.9 2.0 2.2 2.3 2.4 2.5 2.6 2.6 2.8 3.0 3.1 3.2 3.4 3.5
36 91 1.5 1.7 1.8 2.0 2.1 2.2 2.3 2.4 2.5 2.5 2.7 2.9 3.0 3.1 3.2 3.4
34 86 1.5 1.6 1.8 1.9 2.0 2.1 2.2 2.3 2.4 2.4 2.6 2.7 2.9 3.0 3.1 3.2
32 81 1.4 1.6 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.3 2.5 2.6 2.7 2.9 3.0 3.1
31 79 1.4 1.5 1.6 1.8 1.9 2.0 2.0 2.1 2.2 2.3 2.4 2.6 2.7 2.8 2.9 3.0
30 76 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.2 2.2 2.4 2.5 2.6 2.7 2.8 2.9
in cm
kg 7 9 11 13 15 16 18 20 22 24 27 31 35 38 42 45
lbs 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100
Weight
(Figure 5.2c– Predicted Minute Ventilation based on Height and Weight – Pediatric Female)
MALE Predicted MV (L/min)

60 152 2.6 2.8 3.0 3.2 3.4 3.6 3.8 3.9 4.1 4.2 4.5 4.7 5.0 5.2 5.4 5.6
58 147 2.5 2.7 3.0 3.2 3.3 3.5 3.7 3.8 4.0 4.1 4.4 4.6 4.8 5.0 5.2 5.4
56 142 2.4 2.7 2.9 3.1 3.3 3.4 3.6 3.7 3.9 4.0 4.3 4.5 4.7 4.9 5.1 5.3
54 137 2.4 2.6 2.8 3.0 3.2 3.3 3.5 3.6 3.8 3.9 4.2 4.4 4.6 4.8 5.0 5.2
52 132 2.3 2.5 2.7 2.9 3.1 3.3 3.4 3.5 3.7 3.8 4.0 4.3 4.5 4.7 4.8 5.0
50 127 2.2 2.5 2.7 2.8 3.0 3.2 3.3 3.4 3.6 3.7 3.9 4.1 4.3 4.5 4.7 4.9
48 122 2.2 2.4 2.6 2.8 2.9 3.1 3.2 3.3 3.5 3.6 3.8 4.0 4.2 4.4 4.6 4.7
46 117 2.1 2.3 2.5 2.7 2.8 3.0 3.1 3.2 3.4 3.5 3.7 3.9 4.1 4.3 4.4 4.6
Height
44 112 2.0 2.2 2.4 2.6 2.7 2.9 3.0 3.1 3.3 3.4 3.6 3.8 4.0 4.1 4.3 4.4
42 107 2.0 2.2 2.3 2.5 2.6 2.8 2.9 3.0 3.1 3.3 3.5 3.6 3.8 4.0 4.1 4.3
40 102 1.9 2.1 2.3 2.4 2.6 2.7 2.8 2.9 3.0 3.1 3.3 3.5 3.7 3.9 4.0 4.1
38 97 1.8 2.0 2.2 2.3 2.5 2.6 2.7 2.8 2.9 3.0 3.2 3.4 3.6 3.7 3.9 4.0
36 91 1.8 1.9 2.1 2.2 2.4 2.5 2.6 2.7 2.8 2.9 3.1 3.3 3.4 3.6 3.7 3.8
34 86 1.7 1.9 2.0 2.1 2.3 2.4 2.5 2.6 2.7 2.8 3.0 3.1 3.3 3.4 3.6 3.7
32 81 1.6 1.8 1.9 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 3.0 3.1 3.3 3.4 3.5
31 79 1.6 1.7 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.8 2.9 3.1 3.2 3.3 3.4
30 76 1.5 1.7 1.8 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.9 3.0 3.1 3.3 3.4
in cm
kg 7 9 11 13 15 16 18 20 22 24 27 31 35 38 42 45
lbs 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100
Weight
(Figure 5.2d– Predicted Minute Ventilation based on Height and Weight – Pediatric Male)
6 Alarm System
The ExSpiron 1Xi includes an alarm system which generates visual and audible alarm signals in response
to the detection of technical or physiological alarm conditions. Technical alarm conditions are
preconfigured and include conditions such as “Low Battery” or “PadSet Detached”. Physiological alarm
conditions such as “Low MV” and “Low RR” are can be configured by the user.
6.1 Physiological Alarm Conditions
High and low alarm limits are configured on the Set Limits Pop-up. All physiological alarm are considered
medium priority to indicate the need for a prompt response.

P/N 10483 Rev E
The following alarm conditions are configured and accepted by the operator from the Set Limits Pop-up
before each monitoring session:
• Low MV
• Low TV
• Low RR
• High MV
• High TV
• High RR
6.1.1 Default Alarm Settings

When a session begins, the Low MV alarm limit is set to 40% of predicted MV for a Basic Monitoring or
Volume Synchronization session, and 40% of baseline MV for a Percent Baseline session. All other
physiological alarm conditions are toggled off by default. The MV marker is set to 80% of predicted MV
for Basic Monitoring or Volume Synchronization sessions. For a Percent Baseline session, the MV marker
is set to 80% of baseline MV. The alarm and marker settings require acceptance by the user before
monitoring can begin.
Predicted MV is based on the body surface area (BSA) according to the following formulas:
MVPRED = 4.0 x BSA (men)
MVPRED = 3.5 x BSA (women)
The BSA formula is BSA(m2)= 0.0101 x W0.425 x H0.725. Where W is in pounds and H is in inches.
The No Breath Detected Period alarm is set to 30 seconds by default when a new Patient is selected.
Alarm limits are stored for each patient and will be recalled from any monitoring session to the next.
Alarm limits set during a Percent Baseline session are stored separately from alarm limits set during a
Basic Monitoring or Volume Synchronization monitoring session. Alarm limits do not transfer between
session types even if a patient undergoes different monitoring modalities.
6.1.2 Alarm Delays

Physiological alarms are triggered when a physiological metric (MV, TV or RR) is outside the limits set by
the user for a period of time determined by the MV/TV/RR Alarm Delay setting on the Advanced Setting
tab, the default is 30 seconds (see Advanced Tab, section 4.11.3).
Because physiological measurements are based on a 30-second window of data, there is an inherent delay
of between 60 seconds up to 150 seconds depending on the chosen delay.
The “No Breath Detected Period” alarm condition is reported when there is a 30 sec, 45 sec, 60 sec, 90 sec
or 120 sec window without a breath depending on the chosen Period.
6.2 Technical Alarm Conditions
Technical alarm conditions cannot be reconfigured by users. All technical alarm conditions are considered
low priority and indicate that operator awareness is required. Technical alarm signals (audible and visual)
are generated within 10 seconds of the onset of the triggering event and stop within 10 seconds of the
alarm condition’s resolution. The following technical alarm conditions are monitored by the Alarm
System:
• Low Battery
o Alarm is triggered when the battery life is below 10%.

P/N 10483 Rev E
o Alarm is resolved when the Power Cable is plugged in.
• PadSet Detached
o Alarm is triggered when the ExSpiron 1Xi PadSet is pulled off the patient’s skin or when
the PadSet is detached from the Patient Cable.
o Alarm is resolved when the ExSpiron 1Xi PadSet is correctly adhered to the patient and
connected to the Patient Cable.
• Signal Interference
o Alarm is triggered when the system detects interference from other equipment including
high frequency surgical systems.
o Alarm is resolved when the system has 30 seconds of good signal and can calculate MV,
TV and RR.
o Alarm can also be triggered by an intermittently disconnected PadSet or Patient Cable.
o Note: The audible alarm signal for this alarm condition is generated only if:
▪ The ExSpiron 1Xi detects intermittent interference for 5 consecutive minutes
▪ The ExSpiron 1Xi detects interference so severe that it is impossible to calculate
MV, TV and RR for more than 30 seconds.
▪ The Disable ‘SINGAL INTERFERENCE” Audible Alarm checkbox is not selected.
• High Impedance
o Alarm is triggered when the patient’s baseline impedance is too high.
o May be resolved by replacing the Electrode PadSet.
• Low Impedance
o Alarm is triggered when the patient’s baseline impedance is too low.
o May be resolved by replacing the Electrode PadSet.
• High Baseline
o Alarm is triggered when the patient’s collected baseline MV is high as compared with the
patient’s predicted MV (based on height, weight, and gender).
o Alarm sound can be resolved by choosing to use the high baseline.
o Alarm condition can be resolved by recalculating the baseline or choosing a previous
baseline.
• Low Baseline
o Alarm is triggered when the patient’s collected baseline MV is low as compared with the
patient’s predicted MV (based on height, weight, and gender).
o Alarm sound can be resolved by choosing to use the low baseline.
o Alarm condition can be resolved by recalculating the baseline or choosing a previous
baseline.

P/N 10483 Rev E
6.3 Setting Alarm Limits and MV Marker
1
The Set Limits Pop-up is used to define the range of values that will
trigger an alarm for a specific respiratory parameter (MV, TV and
RR) and a specific condition (Low or High). The Set Limits Pop-up is 4
accessible from the Basic Monitoring Screen (4.5), the Percent
Baseline Screen (4.6), and the Volume Synchronization Screen (4.8).
When the pop-up is accessed from the Basic Monitoring Screen or the
Volume Synchronization Screen, the limits for MV and TV are set in
units of L/min and mL respectively. When the pop-up is accessed
from the Percent Baseline Screen, the limits for MV and TV are set as
a percentage of the baseline measurement.
Note: All physiological alarms are turned off by default until 3
configured by the operator.
Figure 6.3a shows the controls for configuring an alarm limit. Each
respiratory parameter (MV, TV and RR) has a section (1) with two
alarm limits, low and high, which can be turned on or off via toggle
buttons (2). The left-hand slider (3) controls the low alarm limit and
the right-hand slider controls the high alarm limit. The text boxes (4)
above the sliders indicate the levels to which the alarm limits are set. 2
When the button is toggled to its “Off” state, (shown in 6.3a) the (Figure 6.3a
slider control is disabled and the text box displays the word “Off”. Set Limit Control)
When the Set Limits Pop-up (Figure 6.3b) is displayed for the first time in a Basic Monitoring session,
Percent Baseline session, or Volume Synchronization session all alarm are turned off by default.
To Set Alarms:
To turn an alarm on, press the toggle button (2) below the alarm slider. This enables the slider and changes
its color from gray to blue. Move the slider (3) to set the limit for the alarm; verify the value in the
corresponding text box above (4). Click OK (6) to close the pop-up and apply the changes. Click Cancel
(7) to close the pop-up without applying the changes. Be sure not to set alarm so low or so high that they
are effectively disabled. Setting a low alarm at its minimum value or a high alarm at its maximum value
will turn the alarm off.
The MV Marker:
The MV Marker (5) is used to place a dashed white line on the MV Trend. This value appears on the Basic
Monitoring screen, the Percent Baseline screen, and the Volume Synchronization screen. The MV marker
is for information only and does not trigger an alarm signal if the value is crossed.

P/N 10483 Rev E
1 5
4
7
8
6
(Figure 6.3b - Set Limits Pop-up)

1 Field Title Indicates the parameter affected by the alarm setting (MV, TV, or RR)
2 Toggle Enables or disables the slider and indicates whether the slider sets the low
Button limit or the high limit.
3 Slider Sets the value for the alarm limit.
4 Numerical Shows the value for the alarm limit. This shows the word “Off” if the alarm
Display is disabled.
5 MV Marker Allows user to set MV marker on Monitor screen
6 OK Applies changes to alarm settings.
7 Cancel Returns to Monitoring Screen
8 Low Slider Determines lower alarm limit. The alarm will sound if parameter is below
this value.
9 High Slider Displays upper alarm limit. The alarm will sound if parameter is above this
value.
6.4 Alarm Limits on the Monitoring Screens

The alarm on/off symbol (1) is displayed to the right of each respiratory parameter and indicates whether
alarm limits have been configured for the parameter. The symbol may take on any of the following forms:

P/N 10483 Rev E
Alarm Limits Not Configured Alarm limits Configured Alarms Paused
Once configured, alarm limits appear in two places: below the alarms symbol (1), in the white alarm limits
boxes (2), and as the Marker and Alarm areas on the Trend (3 and 4, respectively).
The MV trend shows two additional lines. A solid white line is located at the baseline or Predicted MV,
and the area under the MV marker is shaded pale yellow, whereas the area under the Low MV alarm limit
is shaded in bold yellow.
1
2
3
2 4
(Figure 6.4 - Alarm Limits and MV Trend Lines)
6.5 Alarm Signals

If a respiratory parameter crosses an alarm limit and triggers an alarm (Figure 6.5), the ExSpiron 1Xi
emits an audible tone and displays the alarm condition at the top of the screen (1). The value of the
respiratory parameter that triggers the alarm will also turn bold yellow (2). In some cases, multiple
respiratory parameters may trigger alarm at the same time. Examples of alarm conditions may be “MV
LOW” or “TV HIGH”. Technical alarm conditions are also displayed here, such as “Low Battery” or
“Signal Interference.”

P/N 10483 Rev E
1
(Figure 6.5 - Alarm Signal)

P/N 10483 Rev E
6.6 Pausing Alarms
The alarm system can be paused at any time by pressing Pause Alarms (3) at the bottom right of the
Monitoring Screen, shown in figure 6.5. While the alarm system is paused, no alarm sounds will be
generated, and the alarm message at the top of the screen is replaced by the text “ALARMS PAUSED”. If
a physiologic alarm is triggered, the value will still turn bold yellow, even if the alarm system is paused.
The alarm system will remain paused for 2 minutes after the button is pressed. Alarms can be unpaused by
pressing the Unpause Alarms button (4). Alarms will resume after two minutes if not manually unpaused.
The alarm paused state is shown in figure 6.6.
(Figure 6.6 - Alarms Paused)
6.7 Verifying the Functionality of the Alarm System

To verify the functionality of the ExSpiron 1Xi alarm system, simply turn on the monitor. On startup, the
ExSpiron 1Xi will generate a Low-priority alarm signal consisting of two beeps. This verifies that the
speaker and the alarm system are functioning. If this test case fails, contact technical support (Appendix D:
Support).

P/N 10483 Rev E
7 IntelliVue Communication
The ExSpiron 1Xi can be connected to a Philips IntelliVue Patient Monitor and will transmit values to be
displayed. The Philips Patient Monitor must support the IntelliBridge EC10 Module or the VueLink Open
Interface Module to use this feature.
NOTE: The ExSpiron 1Xi USB ports are available only when the ExSpiron 1Xi is
connected to AC power. Ensure the ExSpiron 1Xi is connected to AC power to use
this feature.
7.1 Connecting with IntelliBridge Components
(Figure 7.1 - IntelliBridge Required Components)
Connect the Required components as shown in figure 7.1. The components are as follows:
1) ExSpiron 1Xi with software version 1.2.0 or higher.
2) USB-to-Serial Cable (Respiratory Motion P/N RMI-51140)
3) IntelliBridge EC5 ID module (labeled: Open Interface #104).
4) CAT5 Cable, straight wired (max 10m)
5) Philips Patient Monitor fitted with
a. IntelliBridge EC10 module (option #101 rev. H or higher),
or
b. IntelliBridge EC10 Interface Board.

P/N 10483 Rev E
7.2 Connecting with VueLink Components
(Figure 7.2 - VueLInk Required Components)
Connect the Required components as shown in figure 7.2. The components are as follows:
1) ExSpiron 1Xi running software version 1.2.1 or higher.
2) USB-to-Serial Cable (Respiratory Motion P/N RMI-51140)
3) VueLink Open Interface Cable with 9-pin Connector (Respiratory Motion P/N RMI-51145, Philips
P/N M1032-61699)
4) Philips Patient Monitor fitted with a VueLink Open Interface Module Auxiliary Plus (Type B,
Respiratory Motion P/N RMI-51150, Philips P/N M1032A#A05) configured with the Digital Open
Interface Driver (Philips P/N M1032-60605)
7.2.1 Specific configuration of the VueLink Interface Module

• Philips VueLink Interface Modules are generally inoperable until the appropriate drivers are loaded
• The Open Interface Driver is stored in the VueLink Interface Module and has to be loaded by
trained personnel. The driver can only be loaded in “Configuration Mode” on the Philips monitor,
which is password-protected and only accessible by qualified technical staff.
• Once the Open Interface driver is loaded in the VueLink module, it is assigned to one of the three
LEDs at the module's front panel
• Note: Activation of previously loaded Open Interface driver is done automatically in the normal
monitoring mode and does not require additional configurations

P/N 10483 Rev E
7.3 Transmitted Data and Alarms
The data from the ExSpiron 1Xi that can be displayed on the Philips Patient Monitor is the respiratory
trace (IntelliBridge Only) and the three parameters: Minute Ventilation (MINVOL), Tidal Volume (TV)
and Respiratory Rate (RRaw).
All ExSpiron 1Xi alarms are transmitted to the Philips IntelliVue Monitor. Pausing alarms on the
ExSpiron 1Xi pauses ExSpiron-related alarms on the Philips Patient Monitor. Alarm conditions
transmitted by ExSpiron 1Xi will appear on the IntelliVue monitor within 10 seconds.
7.4 Operation
• Note that the USB ports on the ExSpiron 1Xi are only active when the ExSpiron 1Xi is connected
to AC power. Connection to IntelliVue cannot be established or maintained without AC power.
• Upon connection, an icon, shown in figure 7.4a, in the upper right corner of the ExSpiron changes
appearance to indicate that communication has been established, shown in figure 7.4b.
(Figure 7.4a - Not connected to IntelliVue monitor) (Figure 7.4b - Connected to IntelliVue monitor)
• The waveforms and metrics will appear on the Philips Patient Monitor within 120 seconds.
• Disconnection of the cable from either device will interrupt communication and will result in loss
of waveforms and numeric metrics on the Philips Monitor. There is no loss or interruption of
monitoring on the ExSpiron monitor.
• Reconnecting the cable will restore communication - no other user interaction is needed.
• The ExSpiron 1Xi cannot be controlled from the Philips Patient Monitor. Nor can the Philips
Patient Monitor be controlled from the ExSpiron 1Xi monitor.
• No personal health information is transmitted between the ExSpiron 1Xi and the Philips Patient
Monitor.

P/N 10483 Rev E
8 Nurse Call Communication
The ExSpiron 1Xi can be connected to a Nurse Call Accessory (Respiratory Motion P/N RMI-51155) that
will communicate audible alarms generated on the ExSpiron 1Xi to a Nurse Call system via a 1/4” Nurse
Call Cable (Respiratory Motion P/N RMI-51160). The Nurse Call feature is available for software revision
L and above. To enable this feature, contact Phone Support at +1 781-373-1636. It is recommended this
accessory be used with a non-latching Nurse Call System.
NOTE: The ExSpiron 1Xi USB ports are available only when the ExSpiron 1Xi is connected to AC
power. Ensure the ExSpiron 1Xi is connected to AC power to use this feature.
8.1 Installation
Included with the Nurse Call Accessory (NCA) is a NCA mount, and a cable clip for the Nurse Call Cable.
Apply the mount to the back of the ExSpiron 1Xi. Firmly press the mount into place ensuring full contact
over the entire adhesive surface area. Ensure it is flush with the top surface and 1.5” from the pole clamp
(Figure 8.1a). Attach the Nurse Call Cable clip to the side of the monitor foot (Figure 8.1b). Once
mounted, plug in the NCA USB cable into one of the ExSpiron 1Xi rear USB ports (Figure 8.1c). Connect
the NCA to a Nurse Call System using the Nurse Call Cable.
(Figure 8.1a – NCA mount) (Figure 8.1b – Nurse Call Cable clip)
(Figure 8.1c – Connected NCA)
8.2 Operation
The Nurse Call Accessory is connected to the ExSpiron 1Xi via the attached USB cable. Connection to the
Nurse Call Accessory requires continuous AC power and proper system configuration. Upon connection,
an icon (Figure 8.2a) in the ExSpiron 1Xi header changes appearance (Figure 8.2b) to indicate that
communication has been established. All audible ExSpiron 1Xi alarms are transmitted via the Nurse Call

P/N 10483 Rev E
Accessory. Pausing alarms on the ExSpiron 1Xi pauses ExSpiron-related alarms being sent to the Nurse
Call System. Alarm conditions transmitted by ExSpiron 1Xi will relay to the Nurse Call Accessory within
10 seconds.
(Figure 8.2a - Not connected to Nurse Call Accessory) (Figure 8.2b - Connected to Nurse Call Accessory)
8.3 Interconnection Diagram

Nurse Call Cable
USB Cable Nurse Call (RMI-51160) Non-latching
ExSpiron 1Xi Accessory Nurse Call
(RMI-51155) System
(Figure 8.3 – Nurse Call Interconnection Diagram)

P/N 10483 Rev E
Appendix A: Accessories
Accessory Model # Maximum Cable Length
ExSpiron 1Xi Patient Cable RMI-51130 8 ft
ExSpiron 1Xi Adult PadSet RMI-51110 N/A
ExSpiron 1Xi Pediatric PadSet RMI-53040 N/A
ExSpiron 1Xi User Manual US RMI-51210 N/A
Medical Grade Power Cable RMI-51250 10 ft
USB to Serial Converter RMI-51140 3 ft
VueLink Open Interface Cable RMI-51145 14 ft
VueLink Open Interface Module RMI-51150 N/A
Nurse Call Accessory RMI-51155 N/A
Nurse Call Cable RMI-51160 8 ft
Appendix B: Specifications and EMC Declarations
Size: 12” (H) x 12” (W) x 6” (D)

Weight: 9 pounds
Operating conditions: 5o – 32o C (40o – 90o F)
20% - 80% non-condensing humidity
Altitude: 0-2000m
Storage and transport: -20o – 65o C (-4o – 149o F)
20% - 80% non-condensing humidity
Altitude: 0-2000m
Fuse: F1, F2 250V, 2A T
Rated AC Power: 100-240 V ~2A, 50/60 Hz
Effective Sound Pressure Levels: 60-70dB
Standards compliance:  IEC 60601-1
o Class 1 protection against electric shock.
o Type BF applied part
o For continuous use
o IPX2
o Not suitable for use in in an oxygen rich environment
 IEC 60601-1-2
o Class A Emissions

P/N 10483 Rev E
o FCC Certification
EMC Declarations
Table 1 – Guidance and Manufacturer’s Declaration – Emissions

All ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration - Emissions
The ExSpiron 1Xi Respiratory Volume Monitor is intended for use in the electromagnetic
environment specified below. The customer or user of the ExSpiron 1Xi Respiratory Volume
Monitor should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions Group 1 The ExSpiron 1Xi Respiratory Volume Monitor uses RF

energy only for its internal function. Therefore, its RF
CISPR 11
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions Class A The ExSpiron 1Xi Respiratory Volume Monitor is

suitable for use in all establishments, other than domestic,
CISPR 11
and those directly connected to the public low-voltage
Harmonics Class A power supply network that supplies buildings used for
domestic purposes.
IEC 61000-3-2
Flicker Complies
IEC 61000-3-3

P/N 10483 Rev E
Table 2 – Guidance and Manufacturer’s Declaration – Immunity
All ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration – Immunity

Immunity Test EC 60601 Compliance Electromagnetic Environment

– Guidance
Test Level Level
ESD ±6kV Contact ±6kV Contact Floors should be wood,

concrete or ceramic tile. If
IEC 61000-4-2 ±8kV Air ±8kV Air
floors are synthetic, the r/h
should be at least 30%
EFT ±2kV Mains ±2kV Mains Mains power quality should be

that of a typical commercial or
IEC 61000-4-4 ±1kV I/Os ±1kV I/Os
hospital environment.
Surge ±1kV ±1kV Mains power quality should be

Differential Differential that of a typical commercial or
IEC 61000-4-5
hospital environment.
±2kV Common ±2kV Common
Voltage >95% Dip for 100% Dip for Mains power quality should be
Dips/Dropout that of a typical commercial or
0.5 Cycle 0.5 Cycle
hospital environment. If the
IEC 61000-4-11
user of the ExSpiron 1Xi
60% Dip for 60% Dip for Respiratory Volume Monitor
requires continued operation
5 Cycles 5 Cycles during power mains
interruptions, it is
recommended that the
30% Dip for 30% Dip for ExSpiron 1Xi Respiratory
25 Cycles 25 Cycles Volume Monitor be powered
from an uninterruptible power
supply or battery.
>95% Dip for 100% Dip for
5 Seconds 5 Seconds
Power Frequency 3A/m 3A/m Power frequency magnetic

fields should be that of a
50/60Hz
typical commercial or hospital
Magnetic Field environment.
IEC 61000-4-8

P/N 10483 Rev E
Table 4 – Guidance and Manufacturer’s Declaration – Immunity
ME Equipment and ME Systems that are NOT Life-supporting
Guidance and Manufacturer’s Declaration – Immunity

Immunity IEC 60601 Test Compliance Electromagnetic Environment – Guidance

Test Level Level
Conducted 3 Vrms (V1)=3Vrms Portable and mobile communications

RF equipment should be separated from the
150 kHz to 80
ExSpiron 1Xi Respiratory Volume
IEC 61000- MHz (E1)=3V/m Monitor by no less than the distances
4-6
calculated/listed below:
3 V/m
Radiated RF 80 MHz to 2.5 D=(3.5/V1)(Sqrt P)
IEC 61000- GHz
150kHz to 80MHz
4-3
D=(3.5/E1)(Sqrt P)
80 to 800 MHz
D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
where P is the max power in watts and D

is the recommended separation distance in
meters.
Field strengths from fixed transmitters, as

determined by an electromagnetic site
survey, should be less than the compliance
levels (V1 and E1).
Interference may occur in the vicinity of

equipment containing a transmitter.

P/N 10483 Rev E
Table 6 – Recommended Separation Distances between portable and mobile RF Communications
Equipment and the ExSpiron 1Xi Respiratory Volume Monitor
ME Equipment and ME Systems that are NOT Life-supporting
Recommended Separations Distances for the ExSpiron 1Xi Respiratory Volume Monitor
environment in which radiated disturbances are controlled. The customer or user of the
ExSpiron 1Xi Respiratory Volume Monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications
Equipment and the ExSpiron 1Xi Respiratory Volume Monitor as recommended below,
according to the maximum output power of the communications equipment.
Max Output Power Separation (m) Separation (m) Separation (m)

(Watts) 150kHz to 80MHz 80 to 800MHz 800MHz to 2.5GHz
D=(3.5/V1)(Sqrt P) D=(3.5/E1)(Sqrt P) D=(7/E1)(Sqrt P)
0.01 0.116667 0.116667 0.233333
0.1 0.368932 0.368932 0.737865
1 1.166667 1.166667 2.333333
10 3.689324 3.689324 7.378648
100 11.66667 11.66667 23.33333

P/N 10483 Rev E
Appendix C: Clinical Studies to Determine Accuracy
Four similar clinical studies provided ExSpiron 1Xi accuracy information.
The first study compared ExSpiron 1Xi Volume Synchronization measurements to measurements made
with Wright/Haloscale Respirometer. This study produced measurement performance statistics and
confirmed that the ExSpiron 1Xi calibration is stable for 24 hours.
The second study compared the Wright/Haloscale Respirometer to the Morgan SpiroAir LT diagnostic
spirometer. Results of these two studies were combined mathematically to produce measurement
performance statistics relative to the Morgan spirometer.
The third study compared ExSpiron 1Xi measurements in Basic Monitoring mode to measurements made
in Volume Sync mode. This study confirmed that measurements made on the ExSpiron 1Xi in Basic
Monitoring mode are equivalent to measurements made in Volume Sync mode.
The fourth study compared the ExSpiron 1Xi Volume Synchronization measurements to measurements
made with a Philips NM3 respiratory profile monitor in pediatric patients. This study produced
measurement performance statistics and confirmed that the ExSpiron 1Xi can perform accurate respiratory
volume measurements in pediatric patients.
ExSpiron 1Xi – Wright comparison (Volume Synchronization)
A clinical study compared simultaneous measurements from the ExSpiron 1Xi with Volume
Synchronization and the Wright/Haloscale Respirometer. Twenty subjects representing a broad range of
intended patients participated in the study. (Age range: 20-84, BMI range: 19.9-43.2, 11 female, 9 male)
The study involved two sessions for each subject, an initial session in which electrodes were applied, the
ExSpiron was calibrated to the individual, and each subject performed 10 breathing tests. Tidal volume,
minute ventilation, and respiratory rate were measured simultaneously by the ExSpiron 1Xi and the
Wright/Haloscale Re spirometer. Each subject returned twenty-four hours after the first session with the
original electrodes still attached. Using the same individual calibration values, a second set of 10 breathing
tests was performed.
The results of the ExSpiron 1Xi comparison indicate that the individual calibration is stable over a 24-hour
period.
ExSpiron 1Xi-Wright Minute Respiratory
Comparison Ventilation Tidal Volume Rate
Overall -2.1% -1.9% -0.2%
Bias Day 1 -2.3% -1.7% -0.6%
Day 2 -1.9% -2.0% 0.2%
Overall 10.5 % 10.3 % 2.0 %
Precision Day 1 10.2% 9.7% 2.3%
Day 2 10.8% 10.8% 1.6%
Overall 10.7 % 10.4 % 2.0 %
Accuracy Day 1 10.4% 9.8% 2.4%
Day 2 10.9% 11.0% 1.6%

P/N 10483 Rev E
RMI performed a Bland-Altman analysis of
the clinical trial data. (See Bland and Altman,
The Lancet, vol. 327, issue 8476, pp. 307-
310, February 1986.) The analyses
confirmed that the average disparity between
ExSpiron 1Xi and the Wright/Haloscale
Respirometer was small and clinically
irrelevant (differences of -0.2 bmp, -5ml and
-0.14 L/min for RR, TV, and MV,
respectively).
RMI calculated the difference between
ExSpiron 1Xi and the Wright/Haloscale
Respirometer for each measure (MV, TV, and
RR) and calculated the average of ExSpiron
1Xi and the predicate for each measure. The
resulting plots are shown below. Data from
different subjects are depicted with a different
color/symbol combination (i.e. blue plus sign
is one subject, cyan plus sign in another
subject, blue circle is a third subject, etc.).
The charts show each subject’s averaged
data. The middle black dashed line on each
plot depicts the average difference and the
upper and lower black dashed lines indicate
the 95% confidence intervals (±2 SD from the
mean). The mean differences between devices Bland-Altman plots of ExSpiron 1Xi-Wright comparison
in all six plots are essentially zero.
Subject demographics
The demographics of the twenty subjects are shown in these tables.
Age Range Gender Race BMI Range
18.5-
20-29 3 female 11 Asian 2 11 normal
24.9
30-39 3 male 9 white 16 25-29.9 4 overweight
40-49 4 black 2 30-39.9 3 obese
morbidly
50-59 4 Hispanic 0 40+ 2
obese
60-69 2
70-79 2
80-89 2
The range of ages, 20-84, is consistent with ExSpiron 1Xi’s intended use with adults, at 21 years of age.
The maximum subject body mass index (BMI) was 43.2.
Subject hydration was not controlled in this study. Test data indicate that measurement performance is not
sensitive to a subject’s baseline impedance, an indicator of hydration.

P/N 10483 Rev E
Wright spirometer – Morgan SpiroAir LT diagnostic spirometer study
A second, similar study was performed
comparing the Wright/Haloscale
Respirometer to the Morgan SpiroAir
LT diagnostic spirometer. (The closed
cell construction of the Morgan
spirometer limits the individual
breathing test time to 30 seconds. A
direct comparison of the ExSpiron 1Xi
to the Morgan spirometer is not
feasible.) A different set of twenty
subjects participated. (Age range: 20-
60, BMI range: 19.0-28.0, 9 female, 11
male) Each subject participated in one
session performing twenty 30-second
breathing tests with volume
measurements made simultaneously
with the Wright/Haloscale Respirometer
and the Morgan diagnostic spirometer.
The results of the Morgan-Wright
comparison are consistent with the
performance claims in their
Bland-Altman plots. The average disparity between the two spirometers was
documentation, 2% accuracy for the confirmed to be small and clinically irrelevant (differences of 9 ml and 0.13 L/min
Morgan and 2% accuracy in the tested for TV and MV, respectively). Both plots show individual data from all subjects
flow range for the Wright. The Morgan- and from all trials. The middle black solid line on each plot depicts the average
difference and the upper and lower black dashed lines indicate the 95%
Wright study results were: confidence intervals (±2 SD from the mean). The mean differences between
devices in both plots are essentially zero.
Calculated Measurement Performance

Combining the results of the ExSpiron 1Xi-Wright comparison and the Wright-Morgan comparison
provided calculated estimates of ExSpiron 1Xi bias and accuracy with respect to the Morgan diagnostic
spirometer:
ExSpiron Minute
1Xi-Morgan Ventilation Tidal Volume
Bias -1.7% -1.5%
Accuracy 9.9% 9.6%

P/N 10483 Rev E
ExSpiron 1Xi with Basic Monitoring – comparison vs ExSpiron 1Xi with Volume Sync
A clinical study was performed to compare volumetric measurements made with the ExSpiron 1Xi in
Basic Monitoring mode to the same measurements made in Volume Synchronization mode to determine
relative measurement performance. The objective of the study was to determine the accuracy and
correlation of MV, TV and RR measurements reported by the ExSpiron 1Xi in Basic Monitoring mode to
those measurements made in Volume Synchronization mode. Twenty-three subjects from a broad
ambulatory population were recruited. Male and female subjects of varied ethnicities and with a broad
range of heights, weights, and BMIs were recruited for this study. Subjects with substantive
cardiopulmonary co-morbidities were included.
The results of the study demonstrate that the ExSpiron 1Xi in Basic Monitoring mode had clinically useful
measurements of MV, TV, and RR, compared to the same measurements made in Volume
Synchronization mode:
ExSpiron 1Xi with Basic Minute Respiratory

Monitoring-Volume Sync Ventilation Rate
mode Comparison Tidal Volume
Overall 2.2% 2.2% 0.01%
Bias Day 1 3.4% 3.4% 0.02%
Day 2 1.1% 1.1% 0.00%
Overall 7.0% 6.9% 0.08%
Precision Day 1 5.2% 5.1% 0.11%
Day 2 5.1% 5.1% 0.00%
Overall 11.5% 11.4% 0.08%
Accuracy Day 1 10.1% 10.1% 0.11%
Day 2 12.3% 12.3% 0.00%

P/N 10483 Rev E
RMI performed a Bland-Altman analysis of the clinical trial
data. (See Bland and Altman, The Lancet, vol. 327, issue
8476, pp. 307-310, February 1986.) The analyses confirmed
that the average disparity between ExSpiron 1Xi with Basic
Monitoring and the ExSpiron 1Xi with Volume Sync was
small and clinically irrelevant.
RMI calculated the difference between ExSpiron 1Xi with
Basic Monitoring and the ExSpiron 1Xi with Volume Sync
for each measure (MV, TV, and RR) and calculated the
average of ExSpiron 1Xi and the predicate for each measure.
The resulting plots are shown below. The charts show each
subject’s averaged data. The middle black dashed line on
each plot depicts the average difference and the upper and
lower black dashed lines indicate the 95% confidence
intervals (±2 SD from the mean). The mean differences
between devices in all three plots are essentially zero.
Subject demographics
The demographics of the twenty subjects are shown in these Bland-Altman Plots of
Basic Monitoring vs Volume Sync Comparison
tables.
Age Range Gender Race BMI Range
18.5-
20-29 4 female 9 Asian 3 8 normal
24.9
30-39 3 male 11 white 14 25-29.9 8 overweight
40-49 2 black 2 30-39.9 3 obese
morbidly
50-59 6 Hispanic 1 40+ 1
obese
60-69 2
70-79 2
80-89 1
The range of ages, 22-80, is consistent with ExSpiron 1Xi with Basic Monitoring’s intended use with
adults, over 21 years of age.
The maximum subject body mass index (BMI) was 43.
Subject hydration was not controlled in this study. Test data indicate that measurement performance is not
sensitive to a subject’s baseline impedance, an indicator of hydration.

P/N 10483 Rev E
ExSpiron 1Xi for Pediatrics – Validation vs NM3 Respiratory Profile Monitor
A prospective observational study was undertaken to validate the capability of the RVM to accurately
measure TV, MV, and RR in pediatric patients undergoing general anesthesia in the perioperative setting.
This study was registered in ClinicalTrials.gov with an Identifier number of NCT02336022 on December
15, 2014. The study findings were published in Anesthesi and Analgesia in December 2017i.
Pediatric patients between the ages of 1 year and 17 years (Table 1), ASA status I to III, and scheduled to
undergo surgical procedures (Table 2) under general anesthesia were included. Continuous respiratory data
were collected simultaneously from the ExSpiron 1Xi and a Respironics NM3 Respiratory Profile Monitor.
Both the ExSpiron 1Xi and NM3 provide real-time measurements of MV, TV, and RR.
Table 1. Patient demographics
Infants Children Adolescents

(1-2 years) (2 – 12 years) (12-17 years)
Number of Patients 24 24 24
Females, N (%) 9 (38) 6 (25) 12 (50)
Age, mean (SD), years 1.3 (0.2) 5.6 (2.4) 13.9 (1.8)
Weight, mean (SD), kg 10.4 (1.5) 22.7 (8.8) 52.6 (10.6)
Height, mean (SD), cm 78.2 (5.0) 116.1 (17.1) 160.7 (12.4)
BMI, mean (SD), kg/m2 17.0 (1.1) 16.3 (1.9) 20.3 (2.9)
Procedure Time, mean (SD), hours 2.9 (1.7) 2.5 (1.3) 3.1 (1.6)
Table 2. Surgical procedures
Surgery Type N
Urology (Urethroplasty, Ureteral reimplant, Epispadias repair, Hypospadias) 24
Orthopedic (Closed reduction pinning, PAO, Hardware removal femur plate,
Osteotomy, Open reduction internal fixation) 18
Ear, Nose, Eye: Typanomastoidectomy, Septoplasty, Tympanoplasty, Otoplasty,
Cochlear Implant 18
Upper/Lower extremities (Macrodactlyly Reconstruction, Macrodactlyly Excision,
Transposition of finger, Syndactyly Release) 7
Hernia Repair 3
Other 2

P/N 10483 Rev E
Table 3 summarizes the data from all 72 pediatric patients, showing the ExSpiron 1Xi’s mean measurement
bias (ExSpiron − NM3 measurement) of −3.8% for MV, -4.9% for TV, and -1.1% for RR. The mean
measurement accuracies for MV, TV, and RR were 11.9%, 12.0%, and 4.2% (0.6 breaths/min), respectively.
Those accuracies were not different across age groups (Fig 1). Note that, lower accuracy values indicate
higher measurement agreement.
Table 3. Bias, Precision, and Accuracy of ExSpiron vs NM3

Pre-Surgery Post-Surgery Combined
MV TV RR MV TV RR MV TV RR
Bias, mean
1.3 (0.7) 0.1 (0.7) 1.3 (0.3) -7.6 (1.6) -8.6 (1.7) 1.0 (0.4) -3.8 (1.0) -4.9 (1.0) 1.1 (0.3)
(SEM), %
Precision, mean
4.4 (0.4) 3.8 (0.3) 2.4 (0.3) 5.5 (0.7) 5.3 (0.7) 3.2 (0.5) 8.8 (0.6) 8.5 (0.7) 3.4 (0.4)
(SEM), %
Accuracy, mean
7.1 (0.5) 6.6 (0.5) 3.5 (0.3) 14.0 (1.1) 14.4 (1.2) 4.1 (0.5) 11.9 (0.8) 12.0 (0.8) 4.2 (0.4)
(SEM), %
MV, Minute ventilation, TV, Tidal volume; RR, respiratory rate
Figure 1. Mean (± SEM) accuracy of the RVM’s MV, TV, and RR measurements grouped by patient age
sub-populations. MV, TV, and RR accuracy were not significantly different across the three age ranges
(One-Way ANOVA, p = 0.74, 0.53, and 0.14 for MV, TV, and RR, respectively). Note that, lower accuracy
values indicate higher measurement agreement.

P/N 10483 Rev E
Appendix D: Support
Product Support
For on-site product support instructions, please refer to the ExSpiron 1Xi Service Manual that comes
within the same flash drive as this User Manual.
Phone Support
Phone support is available 24/7 by calling +1 781-609-7829.
Training
Training can be scheduled by calling +1 781-373-1636.
Ordering Accessories
You may place phone orders by calling +1 781-373-1636.
Exchange Repair
The Respiratory Motion Exchange Service provides troubleshooting and repairs for your ExSpiron 1Xi
monitor. For a full list of both customer serviceable and manufacturer serviceable parts, please refer to the
ExSpiron 1Xi Service Manual that comes within the same flash drive as this User Manual.

P/N 10483 Rev E
Appendix E: Symbols
Symbol Meaning Symbol Meaning
Respiratory Motion Storage Temperature
Type body floating (BF) applied

For single use only
part
Consult accompanying
For prescription use only
documents
Alarm limits not configured Non-sterile
Alarm limit(s) configured Connected to IntelliVue monitor
Not connected to IntelliVue

Alarm System Paused
monitor
Connected to Nurse Call

USB connection
Accessory
Not connected to Nurse Call

Power on/off
Accessory
Use by date Respiratory
Export a screenshot Manufacturer
Quantity Catalogue Number
Authorized Representative Batch Code
Date of Manufacture Serial Number

P/N 10483 Rev E
Appendix F: References
1. Voscopoulos C, Brayanov J, Ladd D, Lalli M, Panasyuk A, Freeman J. Special article: evaluation of a novel
noninvasive respiration monitor providing continuous measurement of minute ventilation in ambulatory
subjects in a variety of clinical scenarios. Anesth Analg 2013;117:91–100.
2. Voscopoulos CJ, MacNabb CM, Freeman J, Galvagno SM, Ladd D, George E. Continuous noninvasive
respiratory volume monitoring for the identification of patients at risk for opioid-induced respiratory
depression and obstructive breathing patterns. J Trauma Acute Care Surg 2014;77:S208-15.
3. Galvagno SM, Brayanov J, Corneille MG, Voscopoulos CJ, Sordo S, Ladd D, Freeman J. Non-invasive
respiratory volume monitoring in patients with traumatic thoracic injuries. Trauma 2014;17:219–23.
4. Voscopoulos C, Ladd D, Campana L, George E. Non-Invasive Respiratory Volume Monitoring to Detect
Apnea in Post-Operative Patients: Case Series. J Clin Med Res 2014;6:209–14.
5. Holley K, Mathews D, Ladd D, Campana L, Schapiro H. Respiratory Volume Monitoring to Assess the
Effect of Airway Maneuvers on Ventilation during Upper Endoscopy. Open J Anesthesiol 2014;4:281–90.
6. Williams GW, Sharma A, Chen PR. The Application of a Novel Non-Invasive Respiratory Monitor
(ExSpironTM) in the Extubation of a Patient With Persistent Upper Airway Swelling. J Med Cases
2014;5:388–91.
7. Schlesinger JJ. Applications of a Noninvasive Respiratory Volume Monitor for Critical Care Medicine.
Respir Care 2015;60:e97–100.
8. Fleming E, Voscopoulos C, George E. Non-invasive respiratory volume monitoring identifies opioid-
induced respiratory depression in an orthopedic surgery patient with diagnosed obstructive sleep apnea:
a case report. J Med Case Rep 2015;9:94.
9. Mehta JH, David KR, Driedger A. Preventing Extubation Failure by Monitoring Minute Ventilation with
the ExSpiron 1Xi. J Anesth Clin Res 2015;6:555.
10. Voscopoulos CJ, MacNabb CM, Brayanov J, Qin L, Freeman J, Mullen GJ, Ladd D, George E. The evaluation
of a non-invasive respiratory volume monitor in surgical patients undergoing elective surgery with
general anesthesia. J Clin Monit Comput 2015;29:223–30.
11. Williams GW, George CA, Harvey BC, Freeman JE. A Comparison of Measurements of Change in
Respiratory Status in Spontaneously Breathing Volunteers by the ExSpiron Noninvasive Respiratory
Volume Monitor Versus the Capnostream Capnometer. Anesth Analg 2016;M:1–7.
12. Voscopoulos C, Theos K, Tillmann Hein HA, George E. A risk stratification algorithm using non-invasive
respiratory volume monitoring to improve safety when using post-operative opioids in the PACU. J Clin
Monit Comput 2016;18:53–8.
13. Galvagno SM, Duke PG, Eversole DS, George EE. Evaluation of respiratory volume monitoring (RVM) to
detect respiratory compromise in advance of pulse oximetry and help minimize false desaturation
alarms. J Trauma Acute Care Surg 2016;81:S162–70.
14. Holley K, MacNabb CM, Georgiadis P, Minasyan H, Shukla A, Mathews D. Monitoring minute ventilation
versus respiratory rate to measure the adequacy of ventilation in patients undergoing upper endoscopic
procedures. J Clin Monit Comput 2016;30:33–9.
15. Schumann R, Kwater AP, Bonney I, Ladd D, Kim J, Gupta A, Gumbert SD, Pivalizza EG. Respiratory volume
monitoring in an obese surgical population and the prediction of postoperative respiratory depression
by the STOP-bang OSA risk score. J Clin Anesth 2016;34:295–301.
16. Galvagno SM, Brayanov J, Williams G, George EE. Anesthesia and Postoperative Respiratory
Compromise Following Major Lower Extremity Surgery: Implications for Combat Casualties. Mil Med
2017;182:78–86.
17. Ebert TJ, Middleton AH, Makhija N. Ventilation monitoring during moderate sedation in GI patients. J
Clin Monit Comput 2017;31:53–7.

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18. Gomez-Morad, AD, Cravero, JP, Harvey, BC, Bernier, R, Halpin, E, Walsh, B, Nasr, VG. The Evaluation of
a Noninvasive Respiratory Volume Monitor in Pediatric Patients Undergoing General
Anesthesia. Anesth. Analg. 2017 Dec; 125(6):1913-1919. DOI: 10.1213/ANE.0000000000002029

P/N 10483 Rev E

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DO NOT use the ExSpiron 1Xi monitor:

ONLY qualified personnel should use the ExSpiron 1Xi monitor.

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3.3 Mounting the ExSpiron 1Xi

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(Figure 3.5 - Standard Electrode Placement Diagram)

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(Figure 4.2 - Welcome Screen)

Label Button/Field Function

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(Figure 4.3- Patient Selection Pop-up)

Label Button/Field Function

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(Figure 4.4 - Trace screen)

Label Button/Field Function

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(Figure 4.5 – Basic Monitoring screen)

Label Button/Field Function

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(Figure 4.6- Percent Baseline Screen)

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Label Button/Field Function

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(Figure 4.8 – Volume Synchronization Screen)

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4.9 History Pop-up

4.9.1 Trend Tab

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(Figure 4.9.1 - History Trend)

Label Button/Field Function

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(Figure 4.9.2 - Values)

Label Button/Field Function

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(Figure 4.9.3 - Alarms)

Label Button/Field Function

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(Figure 4.10 - Patient Management Pop-up)

Label Button/Field Function

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4.11.1 Defaults Tab

(Figure 4.11.1 – Defaults Tab)

Label Button/Field Function

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(Figure 4.11.2– Displayed Range Tab)

Label Button/Field Function

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(Figure 4.11.3 - Advanced Tab)

Label Button/Field Function