Novametrix Medical Systems 8100 User manual

Novametrix Medical Systems Inc.
PO Box 690
5 Technology Drive
Wallingford, Connecticut, U.S.A. 06492
RESPIRATORY PROFILE MONITOR
User’s Manual
Model 8100
October 10, 1997
Catalog No. 6758-23-02

Rev. 02 CO
2
SMO Plus User’s Manual iii
Revision History
08-Jan-97 Release, Rev 00
17-Jan-97 Production release, Rev 01
10-Oct-97 Revision 02 software, Rev 02
CO
2
SMO Plus! and CAPNOSTAT are registered trademarks and Y-Sensor, SuperBright and OxySnap are trade-
marks of Novametrix Medical Systems Inc. Velcro is a registered trademark of Velcro USA, Inc. Cidex is a trademark
of Arbook, Inc. Nafion is a registered trademark of Dow Corning Corp.
Copyright 1997, Novametrix Medical Systems Inc. This document contains information which is proprietary and the
property of Novametrix Medical Systems Inc., and may not be reproduced,stored in a retrieval system, translated, tran-
scribed or transmitted in any form, or by any means, without prior explicit written permission from Novametrix Med-
ical Systems Inc.

iv CO
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SMO Plus User’s Manual Rev. 02
Thank you . . .
. . . for selecting the CO
2
SMOPlus! Respiratory Profile Monitor. Youare the operator of one
of the most advanced, state-of-the-art respiratory instruments available today. Our
engineering staff, in collaboration with the medical community, has invested considerable
effort to produce a highly accurate and extremely versatile instrument for respiratory
monitoring. While we expect that the CO
2
SMO Plus! will meet your specific needs, we
nonetheless are interested in receiving any comments you may have.
Please review this manual prior to using the monitor. We are available to help you with
servicing or applications questions. You may call toll-free at 1-800-243-3444. In
Connecticut, call collect at [phone].
Sincerely,
Declaration of Conformity with European Union Directives
The authorized representative for Novametrix Equipment is:
European Compliance Services Limited
Oakdene House
Oak Road
Watchfiled
Swindon, Wilts SN6 8TD
UK
WALLINGFORD, CT U.S.A. 06492
PHONE:
IN CONNECTICUT 203-265-7701
FAX [phone]
WORLD WIDE WEB:
Customer Service
Technical Service
http://www.novametrix.com
[email protected]
[email protected]
INTERNET:
TOLL FREE 1-800-243-3444

Rev. 01 CO
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SMO Plus User’s Manual v
Contents
General Description ............................................................................................................1
Indication for use, unpacking, operational overview of the monitor, and principles of operation.
Safety .................................................................................................................................11
Warnings, cautions and notes on the use of the
CO
2
SMO Plus! monitor and its accessories.
Preparation for Use ...........................................................................................................15
AC/battery operation, setup and configuration settings.
Sensors and Patient Connections ...................................................................................23
Detailed information on connection and application of sensors associated with the
CO
2
SMO Plus! .
Covers combination CO2flow, separate CO2and flow monitoring, and SpO2probes.
Monitoring .........................................................................................................................47
Parameters monitored, screen displays, sample waveforms, viewing and entering patient data and
notes on patient monitoring.
HP VueLink Interface ........................................................................................................65
Preparation, setup, and use of the
CO
2
SMO Plus! with the Hewlett Packard VueLink module.
Transmitted parameters and waveforms.
Alerts and Messages ........................................................................................................73
Information on setting alerts, alert indications, audio, and messages related to alerts and other
circumstances.
Maintenance ......................................................................................................................83
General maintenance and cleaning of the monitor and its accessories.
Specifications ....................................................................................................................91
Warranty ............................................................................................................................95
Accessories .......................................................................................................................97

vi CO
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SMO Plus User’s Manual Rev. 01

Rev. 02 CO
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SMO Plus User’s Manual 1
Section 1 General Description
Through the combination of capnography, airway flow and pressure, and pulse oximetry, the CO
2
SMO
Plus!
provides the clinician with a respiratory profile of the patient. This includes information that was
previously difficult to obtain continuously at the bedside, such as CO2production (Vco2) and deadspace
parameters, as well as conventional capnography, pulse oximetry, and respiratory mechanics. The
continuous respiratory profile provided by the
CO
2
SMO Plus! provides the clinician with immediate
feedback that allows precise and efficient patient/ventilator management.
Indication for use
The CO
2
SMO Plus! is intended to be used for monitoring end tidal CO2, respiration rate, functional
oxygen saturation, pulse rate and respiratory mechanics in monitoring environments such as ventilatory
support, emergency and anesthesia.
CO
2
SMO Plus! is designed to monitor adult, pediatric and neonatal
patients.
CO
2
SMO Plus! is not intended for any other purposes.
Unpacking
The box that your CO
2
SMO Plus! was shipped in should contain the items shown below. Please contact
us at 1-800-243-3444, or contact your local sales representative if any items are missing or damaged, or
to order additional accessories.
NOTE
Components of this product and its associated accessories which have patient
contact are free of latex.
Gas compositions other than those selected in the SETUP screen can influence
CO2and flow measurement.
Monitor
Combined CO2/Flow Sensor
CAPNOSTAT CO2 Sensor
User’s Manual Power cord
SpO2-Sensor

Section 1 Operational Overview
2 CO
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SMO Plus User’s Manual Rev. 02
Operational Overview
Parameters Measured
The CO
2
SMO Plus! measures and calculates various respiratory parameters for patient/ventilator
management. Refer to “Monitoring” on page 47 for a complete parameters list.
Front Panel Controls and Indicators
Controls
or Power Key
Press the POWER key to place the unit into operate mode (ON) or to place the unit into standby (OFF).
There are four states of the unit:
• No AC Power, power icon off, not in operate mode
In this condition the AC switch is off, or the power cord is not plugged into an AC outlet, or the
outlet is not powered. No monitoring may occur in this state. Battery is not being charged.
• AC Power, power icon on, not in operate mode (standby)*
In this condition the unit may be placed into operate mode by pressing the key. Battery is
charging in this mode.
• AC Power, power icon on, in operate mode
In this condition the unit is in operating mode and the battery is being charged.
• Battery power, power icon off, battery is not being charged
In this condition the unit is in the operating mode and the battery is not being charged.
When the monitor powers up a self test is performed in which all indicators will temporarily illuminate
and the monitor will emit a short beep. Following the self test the monitor will display:
“ERASE STORED TRENDS?
YES: NO: ”
*The monitor must be in “stand-by” mode in order for the CAPNOSTAT CO2sensor to remain heated when
the monitor is off.

Operational Overview General Description
Rev. 02 CO
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SMO Plus User’s Manual 3
If the or key is not pressed within fiveseconds, trends will be retained. The monitoris now ready
for operation.
Contrast
Press or hold to adjust the display’s contrast for different up/down viewing angles.
Alert Silence
Press for 2 minute silence (audible alerts muted for two minutes). The icon will illuminate for the
duration of the two minute silence. Press again to cancel.
Press and hold for 3 seconds to disable audible alerts, and the icon will flash. Press and hold again
to cancel.
Press to acknowledge a latched alert.
If preconfigured not to allow the audio off function, the key will not disable the audible alerts when
pressed (the two minute silence is still active).
Set Alert Limits
Press to set alert limits manually, or hold to set automatically. Press again to accept the displayed limits
and return to the previous screen. For more detailed information on setting alert limits see “Setting Alert
Limits” on page 80.
Event/Freeze
Press the key to freeze the waveforms and loops for sixty seconds. An EVENT MARKER with time
and date will appear in the message center for three seconds followed by “WAVEFORM FROZEN
UNFREEZE: PRESS EVENT KEY”. To resume normal display press again, otherwise the
waveform will resume again in 60 seconds.
Pressing this key when viewing the DATA entry screen allows you to enter the patient’s PaCO2for
calculation of Vd/Vt phy, Vd phy and Vd alv.
CO
2
Waveform/Plethysmogram
Press to switch waveform display between capnogram and capnogram with plethysmogram.
Flow/Pressure Waveforms
Press to switch waveform display between flow and pressure waveforms or loops, or flow and volume
waveforms and loops (flow vs. volume and volume vs. pressure) display.
Trend
Press to switch between trend screens.

Section 1 Operational Overview
4 CO
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SMO Plus User’s Manual Rev. 02
Data Screen
Press to switch between data screens (numeric values only), and data entry screen (to enter weight and
PaCO2- see “Data Screens” on page 56 for details).
Setup/Configuration
Press to display the SETUP screen, or hold for three seconds to display the CONFIGURATION screen
(for advanced settings). Press again to accept the displayed settings and return to the previous screen.
Refer to “Setup and Configuration Settings” on page 16.
Adjustment Keys
Press to select different parameters in SETUP, CONFIGURATION, SET ALERTS or DATA ENTRY
screen. Press and to change value or state of the currently selected parameter.
The key is also used to:
• Select different time bases on the Trend screens (see “Trend” on page 3)
• Rescale various waveforms if scaling is set to manual (see “Setup and Configuration Settings” on
page 16).
The and keys are also used to respond to monitor prompts such as “ERASE STORED
TRENDS? YES: NO: .”
SET ALERTS
EVENT/FREEZE
- moves pointer
- press to chan
g
e value
SETUP
SETUP (HOLD 3 SECONDS)
- moves pointer
- press to chan
g
e value

Operational Overview General Description
Rev. 02 CO
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SMO Plus User’s Manual 5
CO2/PLETH
FLOW/PRES
STANDARD DATA SCREENS
TREND
- changes time base - moves pointer
- press to change value
PROTOCOL DATA SCREENS
NOTE: screens may vary with future software updates.
*
*STANDARD or PROTOCOL data
.
screens are selected in the CONFIGURATION menu. Press and hold the SETUP key to access.

Section 1 Operational Overview
6 CO
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SMO Plus User’s Manual Rev. 02
Indicators
Battery Alert Icon
Illuminates when the unit is on battery power and the battery charge is critically low. When battery is near
exhaustion an audible alert will sound and “BATTERY VERY LOW PLUG IN AC POWER” will appear
in the display screen. Refer to “AC/Battery Operation” on page 15 for information on connecting AC
power and charging the battery.
AC Power Indicator Icon
Illuminates when the monitor is connected to an AC power source and the rear panel power switch is ON
“ | ”. In this condition the internal battery is charging.
Two Minute Silence Icon
Illuminates when the two minute silence is active.
Audible Alert Disabled Icon
Flashes when audible alerts have been disabled.
Miscellaneous
Graphic Display
Graphic blue/white 240 X 64 pixel dot matrix display.
Alert bar
Flow sensor connection
Graphic display
Sampling system inlet
Explosion hazard WARNING
Top cover instructions Carrying handle

Operational Overview General Description
Rev. 02 CO
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SMO Plus User’s Manual 7
Alert Bar
Flashes red when alert conditions are detected. When ALERTS LATCHED in the SYSTEM
CONFIGURATION is set to ON, the alert bar is latched. This means that when an alert is active, the alert
bar will flash even if the condition that caused the alert has been corrected. To reset the latched alert bar
press, the key.
Sampling System Input
Input connection for sampling system tubing. See “Sampling Adapter” on page 30 for more information.
Flow Sensor Connection
Connection for flow sensors. See “Sensors and Patient Connections” on page 23 and “Monitoring Flow
(Respiratory Mechanics) Separately” on page 28 for more information.

Section 1 Rear Panel Connections and Labeling
8 CO
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SMO Plus User’s Manual Rev. 02
Rear Panel Connections and Labeling
Equipotentiality: Connection to monitor’s chassis
Patient isolation: Identifies connection as type BF
Attention: Consult manual for detailed information
Mains fuse rating for replacement fuses
AC mains switch “ | ” ON-connection to mains; “O” OFF-disconnection from
mains
Recyclable item. This symbol is found on the internal battery and should not
concern the common user. Refer to qualified service personnel when battery
replacement is required.
Separate collection. Appropriate steps must be taken to ensure that spent bat-
teries are collected separately when disposed of. This symbol is found on the
internal battery and should not concern the common user. Refer to qualified
service personnel when battery replacement is required.
Indicates heavy metal content, specifically lead. This symbol is found on the
internal battery and the monitor enclosure and should not concern the common
user. Refer to qualified service personnel when battery replacement is required.
Equipotential connection
SpO2sensor connection
CO2sensor connection
25 pin D connector
Sampling system exhaust
Power cord receptacle
Fuse/power setting compartment
AC power switch
(for communications)
CONNECT ONLY TO
IEC601 APPROVED
DEVICES
250V
Pb

Principle of operation General Description
Rev. 02 CO
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SMO Plus User’s Manual 9
Principle of operation
CO
2
CO
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SMO Plus! uses the CAPNOSTAT CO2sensor to measure CO2by using the infrared absorbtion
technique, which has endured and evolved in the clinical setting for over two decades and remains the
most popular and versatile technique today.
The principle is based on the fact that CO2molecules absorb infrared (IR) light energy of specific
wavelengths, with the amount of energy absorbed being directly related to the CO2concentration. When
an IR beam is passed through a gas sample containing CO2, the electronic signal from the photodetector
(which measures the remaining light energy) can be obtained. This signal is then compared to the energy
of the IR source and calibrated to accurately reflect CO2concentration in the sample. To calibrate, the
photodetector’s response to a known concentration of CO2is stored at the factory in the monitor’s
memory. A reference channel accounts for optical changes in the sensor, allowing the system to remain
in calibration without user intervention.
Respiration Rate
The respiration rate is calculated from the flow signal generated whenever a flow or combined CO2/flow
sensor is connected to the
CO
2
SMO Plus! . If a flow or combined CO2/flow sensor is not connected, and
a CAPNOSTAT CO2sensor is connected, then the respiration rate is calculated from the CAPNOSTAT
CO2sensor signal. In the event that there is no flow, CO2/flow, or CAPNOSTAT CO2sensor connected,
the respiratory rate will not be calculated.
SpO
2
The CO
2
SMO Plus! determines oxygen saturation using sensors that contain red and infrared (660 and
940 nanometer) light sources, called light emitting diodes (LEDs). The light energy from each LED is
beamed through a tissue sample—a pulsating vascular bed such as the patient’s finger or toe. The
remaining light energy not absorbed by the tissue sample reaches a photodiode light receptor in the
sensor. Oxygen saturated blood absorbs different amounts of light at each wavelength as compared to
desaturated blood. Therefore, the amount of light absorbed by the blood in each pulse can be used to
calculate oxygen saturation.
The
CO
2
SMO Plus! is calibrated to display “functional” saturation. This differs from the “fractional”
saturation value displayed by most co-oximeters. Functional saturation is defined as:
This canbe considered to represent the amount of oxyhemoglobin as a percentage of the hemoglobin that
can be oxygenated. Dysfunctional hemoglobins (COHb and METHb) are not included in the
measurement of functional saturation.
Functional Saturation = HbO2
100 - (COHb + METHb)
HbO2 = Fractional Oxyhemoglobin
COHb = Carboxyhemoglobin
METHb = Methemoglobin

Section 1 Principle of operation
10 CO
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SMO Plus User’s Manual Rev. 02
Pulse Rate is calculated by measuring the time interval between peaks of the infrared light waveform.
The inverse of this measurement is displayed as pulse rate.
The oxygen saturation and pulse rate values are updated once each second. Presence of a pulse is
indicated visibly by a plethysmogram graphic display and audibly by a “beep.”
The
CO
2
SMO Plus! must be used in conjunction with SuperBright™ Sensors. See “Accessories” for a
list of available sensors and accessories.
Flow
Flow measurements in the CO
2
SMO Plus! are made by a fixed orifice differential pressure
pneumotachometer. Respired gas flowing through the flow sensorcauses a small pressure drop acrossthe
two tubes connected to the sensor. This pressure drop is transmitted through the tubing to a differential
pressure transducer located inside the monitor, and is correlated to flow according to the factory stored
calibration. User calibration is not required due to the ability of the plastic injection mold to repeatedly
produce precision flow sensors. The pressure transducer is automatically “zeroed” to correct for changes
in ambient temperature and electronics.
The
CO
2
SMO Plus! system software compensations allow accurate flow and volume measurements in
the presence of high oxygen concentrations, anesthetic gases and helium-oxygen mixtures. When
compensated, gas density and viscosity effects do not cause significant errors in flow measurement.
For maximum flow sensor performance:
(1) keep the pressure sensing ports oriented upward;
(2) keep the sensor clear of accumulations by proper breathing circuit maintenance;
(3) confirm that the gas compositions entered correspond to ‘best’ known values (refer to “Setup and
Configuration Settings” on page 16).

Rev. 02 CO
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SMO Plus User’s Manual 11
Section 2 Safety
The CO
2
SMO Plus! monitor is electrically isolated. Patient leakage current flowing from the instrument
to ground is limited to less than 100 uA at 120/220 VAC, 50-60Hz.
For maximum patient and operator safety, you must follow the following warnings and cautions.
• Explosion Hazard: DO NOT use
CO
2
SMO Plus! in the presence of flammable anesthetics. Use of
this instrument in such an environment may present an explosion hazard.
• Electrical Shock Hazard: Always turn
CO
2
SMO Plus! offand remove the line cord before cleaning
it. Refer servicing to qualified service personnel.
• Never sterilize or immerse the monitor in liquids.
• Do not operate
CO
2
SMO Plus! when it is wet due to spills or condensation.
• Do not operate
CO
2
SMO Plus! if it appears to have been dropped or damaged.
• Failure of Operation: If the monitor fails to respond as described, do not use it until the situation
has been corrected by qualified personnel.
•The
CO
2
SMO Plus! is not intended to be used as a primary diagnostic apnea monitor and/or
recording device.
• Patient Safety: Care should be exercised to assure continued peripheral perfusion distal to the
SpO2sensor site after application.
• Inspect the SpO2sensor site often for adequate circulation - at least once every four hours. When
applying sensors take note of patient’s physiological condition. For example, burn patients may
exhibit more sensitivity to heat and pressure and therefore additional consideration such as more
frequent site checks may be appropriate.
• Data Validity: As with all pulse oximeters, inaccurate SpO2and Pulse Rate valuesmay be caused by:
- Incorrect application or use of sensor;
- Significant levels of dysfunctional hemoglobin; carboxyhemoglobin or methemoglobin;
- Significant levels of indocyanine green, methylene blue, or other intravascular dyes;
- Exposure to excessive illumination such as surgical lamps-especially those with a xenon
light source, or direct sunlight;
- Excessive patient movement;
- Venous pulsations;
- Electrosurgical interference.
• A “NO RESPIRATION” alert is not generated when both the CAPNOSTAT CO2sensor and the
flow sensor are disconnected from the
CO
2
SMO Plus! .
•The
CO
2
SMO Plus! automatically identifies the type of flow sensor (neonatal or pediatric/adult)
when it is connected. If a flow sensor identification message is not displayed when a flow or CO2/
flow sensor is first connected, DO NOT use the sensor. If the condition persists, refer the monitor
to qualified service personnel.
WARNINGS
Indicates a potentially harmful condition that can lead to personal injury.
!

Section 2
12 CO
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SMO Plus User’s Manual Rev. 02
• Periodically check the flow sensor and tubing for excessive moisture or secretion build up.
Although the
CO
2
SMO Plus! automatically purges the lines, excessive moisture or secretions may
still remain.
• While using the flow sensor, a system leak, such as that caused by uncuffed endotracheal tubes or
a damaged flow sensor may significantly effect flow related readings. These include flow,
pressure, dead space, CO2production and other respiratory mechanics parameters.
• Connect the line cord to a grounded hospital-grade outlet.
CO
2
SMO Plus! should be connected to
the same electrical circuit as other equipment in use on the patient. Outlets of the same circuit can
be identified by the hospital’s engineering department.
•The
CO
2
SMO Plus! has no protection against the ingress of water.
• Do not operate
CO
2
SMO Plus! when it is wet due to spills or condensation.
• Do not operate
CO
2
SMO Plus! if it appears to have been dropped or damaged.
• Keep
CO
2
SMO Plus! and its accessories clean.
• Never sterilize or immerse the monitor in liquids.
• Do not sterilize or immerse sensors except as directed in this manual.
• Do not apply excessive tension to any sensor cable or pneumatic tubing.
• Do not store the monitor or sensors at temperatures less than 14°F (-10°C) or above 131°F (55°C).
• Do not operate the monitor or sensors at temperatures below 50°F (10°C) or above 104°F (40°C).
• Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a
licensed medical practitioner.
• DO NOT attach an SpO2sensor distal to a blood pressure cuff. Valid data CANNOT be processed
when the cuff is inflated. Attach the sensor to the limb opposite to the site used for the blood
pressure cuff.
• Excessive moisture in the flow sensor may affect the accuracy of the flow measurement.
• To avoidthe effects of excessive moisture in themeasurement circuit, insert the flow sensor in the
ventilator circuit with the tubes upright (as shown by arrows). The striped tube is positioned
closest to the patient. Improper placement will result in erroneous data.
• It is recommended that the CO2/Flow sensorbe removed from the circuit whenever an aerosolized
medication is delivered. This is due to the increased viscosity of the medications which may
contaminate the sensor windows, causing the sensor to fail prematurely.
• In case of interference with our equipment or another manufacturer’s equipment, notify your
Novametrix representative.
• Components of this product and its associated accessories which have patient contact are free of
latex.
• As with all flow measuring devices, adverse conditions may affect the accuracy of the flow
measurement. See page 10 for a discussion of flow measurement.
•IfCO
2is being measured while not using a flow sensor, certain rebreathing circuits, or the
presence of artifacts such as cardiogenic oscillations, may cause
CO
2
SMO Plus! to react to non-
respiratory CO2fluctuations as if they were breaths. This condition affects only the numerical
displays; the capnogram display continues to provide an accurate picture of the CO2waveform.
CAUTIONS
Indicates a condition that may lead to equipment damage or malfunction.
NOTES
Indicates points of particular interest or emphasis for more efficient or convenient operation.
!

Safety
Rev. 02 CO
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SMO Plus User’s Manual 13
• When a new CAPNOSTAT CO2sensor is attached to the monitor, or is moved from one monitor
to another, it must be initialized before use. The CAPNOSTAT CO2sensor does not have to be
initialized again as long as it is used with the same monitor.
• If you use the
CO
2
SMO Plus! for transport or if you drastically change the orientation of the
CO
2
SMO Plus! , the flow sensor must be manually re-zeroed. See page 32 for more information on
the flow sensor zero procedure.
• After the life cycle of our equipment and all accessories has been met, disposal of the equipment
should be accomplished following the national requirements. Contact the local Novametrix
representative for questions concerning disposal.

Section 2
14 CO
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SMO Plus User’s Manual Rev. 02
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