Model 8100 CO2SMO plus Respiratory Profile Monitor Users Manual Oct 1997

Revision History 08-Jan-97

Release, Rev 00

17-Jan-97

Production release, Rev 01

10-Oct-97

Revision 02 software, Rev 02

CO2SMO Plus! and CAPNOSTAT are registered trademarks and Y-Sensor, SuperBright and OxySnap are trademarks 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, transcribed or transmitted in any form, or by any means, without prior explicit written permission from Novametrix Medical Systems Inc.

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Thank you . . . . . . for selecting the CO2SMO Plus! Respiratory Profile Monitor. You are 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 CO2SMO 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 (203) 265-7701. Sincerely,

WALLINGFORD, CT U.S.A. 06492

PHONE: TOLL FREE 1-800-243-3444 IN CONNECTICUT 203-265-7701 FAX 203-284-0753 WORLD WIDE WEB: http://www.novametrix.com INTERNET: Customer Service [email protected] Technical Service [email protected]

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

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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 CO2SMO 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 CO2SMO Plus!. Covers combination CO2 flow, separate CO2 and flow monitoring, and SpO2 probes. 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 CO2SMO 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

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Section 1

General Description

Through the combination of capnography, airway flow and pressure, and pulse oximetry, the CO2SMO 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 CO2 production (Vco2) and deadspace parameters, as well as conventional capnography, pulse oximetry, and respiratory mechanics. The continuous respiratory profile provided by the CO2SMO Plus! provides the clinician with immediate feedback that allows precise and efficient patient/ventilator management.

Indication for use The CO2SMO 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. CO2SMO Plus! is designed to monitor adult, pediatric and neonatal patients. CO2SMO Plus! is not intended for any other purposes.

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 CO2 and flow measurement.

Unpacking The box that your CO2SMO 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. Combined CO2/Flow Sensor SpO2-Sensor CAPNOSTAT CO2 Sensor Monitor

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Operational Overview

Operational Overview Parameters Measured The CO2SMO 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. •

on, not in operate mode (standby)*

AC Power, power icon

In this condition the unit may be placed into operate mode by pressing the charging in this mode. •

AC Power, power icon

key. Battery is

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 CO 2 sensor to remain heated when the monitor is off.

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General Description

Operational Overview

If the or for operation.

key is not pressed within five seconds, trends will be retained. The monitor is now ready

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 duration of the two minute silence. Press again to cancel. Press and hold for 3 seconds to disable audible alerts, and the to cancel.

icon will illuminate for the

icon will flash. Press and hold again

Press to acknowledge a latched alert. If preconfigured not to allow the audio off function, the pressed (the two minute silence is still active).

key will not disable the audible alerts when

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 PaCO2 for calculation of Vd/Vt phy, Vd phy and Vd alv.

CO2 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.

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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 TRENDS? YES:

keys are also used to respond to monitor prompts such as “ERASE STORED NO: .”

SET ALERTS

- moves pointer - press to change value

EVENT/FREEZE

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SETUP

- moves pointer - press to change value

SETUP (HOLD 3 SECONDS)

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- changes time base

TREND

FLOW/PRES

CO2/PLETH

STANDARD DATA SCREENS

CO2SMO Plus User’s Manual

- press to change value

- moves pointer

PROTOCOL DATA SCREENS

CONFIGURATION menu. Press and . hold the SETUP key to access.

or PROTOCOL data * STANDARD screens are selected in the

NOTE: screens may vary with future software updates.

Operational Overview

General Description

*

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Operational Overview

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 Top cover instructions Explosion hazard WARNING

Carrying handle

Graphic display

Alert bar Sampling system inlet Flow sensor connection

Graphic Display Graphic blue/white 240 X 64 pixel dot matrix display.

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Operational Overview

General Description

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.

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Rear Panel Connections and Labeling

Rear Panel Connections and Labeling Equipotential connection SpO2 sensor connection

25 pin D connector (for communications) CONNECT ONLY TO IEC601 APPROVED DEVICES

CO2 sensor connection Fuse/power setting compartment AC power switch Power cord receptacle Sampling system exhaust

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 250V

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 batteries 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.

Pb

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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.

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General Description

Principle of operation

Principle of operation CO2 CO2SMO Plus! uses the CAPNOSTAT CO2 sensor to measure CO2 by 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 CO2 molecules absorb infrared (IR) light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. 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 CO2 concentration in the sample. To calibrate, the photodetector’s response to a known concentration of CO 2 is 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 CO2SMO Plus!. If a flow or combined CO2/flow sensor is not connected, and a CAPNOSTAT CO2 sensor is connected, then the respiration rate is calculated from the CAPNOSTAT CO2 sensor signal. In the event that there is no flow, CO2/flow, or CAPNOSTAT CO2 sensor connected, the respiratory rate will not be calculated.

SpO2 The CO2SMO 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 CO2SMO Plus! is calibrated to display “functional” saturation. This differs from the “fractional” saturation value displayed by most co-oximeters. Functional saturation is defined as: HbO2

Functional Saturation =

100 - (COHb + METHb) HbO2 = Fractional Oxyhemoglobin COHb = Carboxyhemoglobin METHb = Methemoglobin This can be 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.

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Principle of operation

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 CO2SMO 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 sensor causes a small pressure drop across the 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 CO2SMO 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).

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Safety

The CO2SMO 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.

WARNINGS

!

Indicates a potentially harmful condition that can lead to personal injury. • • • • • • • • •

•

• •

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Explosion Hazard: DO NOT use CO2SMO 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 CO2SMO Plus! off and remove the line cord before cleaning it. Refer servicing to qualified service personnel. Never sterilize or immerse the monitor in liquids. Do not operate CO2SMO Plus! when it is wet due to spills or condensation. Do not operate CO2SMO 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 CO2SMO 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 SpO2 sensor site after application. Inspect the SpO2 sensor 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 SpO2 and Pulse Rate values may 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 CO2 sensor and the flow sensor are disconnected from the CO2SMO Plus!. The CO2SMO 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.

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Section 2

•

•

•

•

Periodically check the flow sensor and tubing for excessive moisture or secretion build up. Although the CO2SMO 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, CO2 production and other respiratory mechanics parameters. Connect the line cord to a grounded hospital-grade outlet. CO2SMO 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 CO2SMO Plus! has no protection against the ingress of water.

CAUTIONS

!

Indicates a condition that may lead to equipment damage or malfunction. • • • • • • • • • •

• •

•

•

Do not operate CO2SMO Plus! when it is wet due to spills or condensation. Do not operate CO2SMO Plus! if it appears to have been dropped or damaged. Keep CO2SMO 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 SpO2 sensor 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 avoid the effects of excessive moisture in the measurement 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 sensor be 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.

NOTES Indicates points of particular interest or emphasis for more efficient or convenient operation. • • •

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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. If CO2 is being measured while not using a flow sensor, certain rebreathing circuits, or the presence of artifacts such as cardiogenic oscillations, may cause CO2SMO Plus! to react to nonrespiratory CO2 fluctuations as if they were breaths. This condition affects only the numerical displays; the capnogram display continues to provide an accurate picture of the CO2 waveform.

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Safety

•

•

•

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When a new CAPNOSTAT CO2 sensor is attached to the monitor, or is moved from one monitor to another, it must be initialized before use. The CAPNOSTAT CO2 sensor does not have to be initialized again as long as it is used with the same monitor. If you use the CO2SMO Plus! for transport or if you drastically change the orientation of the CO2SMO 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.

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Preparation for Use

AC/Battery Operation Press the POWER key to place the unit into operate mode (ON) or to place the unit into standby (OFF). The status of the unit is dependent upon both the key and the power source: •

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 charging in this mode. •

AC Power, power icon

key. Battery is

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. The CO2SMO Plus! uses battery power when the line cord is disconnected or the rear panel power switch is OFF (O). The monitor can operate for up to two hours while powered from its internal battery (fully charged). The battery is charging only when the monitor is connected to AC power, the rear panel power switch is ON (|), and the front panel icon is green.

NOTE Excessive alerting reduces battery life when operating on battery power. When the monitor is operating on battery power, and the battery is sufficiently charged, the battery icon on the front panel will be off and a battery icon will appear on the display. The battery level is reflected on the display (by a different icon) by “shading” inside the battery icon (for example, battery fully charged: , battery low: ). Should the battery become exhausted the front panel icon will begin flashing red; the monitor will sound an audible alert, then when the battery is depleted turn itself off. Reconnect the monitor to the AC line to recharge the battery. The battery will be fully recharged in 12 hours.

Long Term Storage If the monitor has not been used or powered by AC mains for an extended time† (3 months or more) allow the battery to charge for 12 hours before use. The monitor may not power up on battery power if the *The monitor must be in “stand-by” mode in order for the CAPNOSTAT CO2 sensor to remain heated when the monitor is off. †The internal battery may slowly discharge over long periods of non-use.

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Section 3

Setup and Configuration Settings

battery is not sufficiently charged. Allow the battery to charge for 12 hours before initial use; refer to the following diagram for charging instructions.

NOTE When the battery is low (blinking on front panel) the monitor will not zero the flow sensor. This may cause the calculations based on the flow signal to drift outside of normal performance specifications. Connect to AC power as soon as possible. To charge the battery, connect the line cord to an AC source and set the rear panel power switch ON (|). Check that the front panel icon is green. Charge the battery for 12 hours.

Setup and Configuration Settings The SETUP and CONFIGURATION screens can be programmed by the user to customize the CO2SMO Plus!. The SETUP screen also allows a CO2 adapter zero, a flow sensor zero, or a flow sensor purge to be performed upon request. To access the SETUP screen press the key. Use the key to move the flashing pointer to the parameter to be set, then adjust using the and arrow keys. Any changes made will be retained when the monitor is turned off. NOTE: To reset the monitor to its factory default settings: with the monitor off, press and hold the key while pressing the key to turn the monitor on.

Use NEXT key to move pointer

Change selected parameter using UP and DOWN arrow keys

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