► Multiple Medical Gas Monitors, Respired/Anesthetic

This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Monitors, Bedside, Respiration/Anesthetic Gas [17-445]

Criticare Systems Inc Draeger Medical Inc GE Healthcare USA MEDRAD Inc Mindray North America Philips (Deutschland) GmbH Spacelabs Healthcare Inc

Scope of this Product Comparison
This Product Comparison covers stand-alone and modular multiple medical gas monitors (MMGMs) that can determine concentrations of anesthetic and respiratory gases (oxygen [O2], nitrous oxide [N2O], carbon dioxide [CO2], and halogenated agents) in the patient breathing circuit during anesthesia. Centralized mass-spectrometerbased respiratory/anesthetic gas monitors that are hardwired to patient rooms or operating rooms (ORs) are excluded. For more information on related monitors, see the Product Comparison titled Carbon Dioxide Monitors, Exhaled Gas. These devices are also called: multigas monitors.

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and warns of equipment failures or abnormalities in the gas delivery system. Principles of Operation Most MMGMs are sidestream monitors. Gas samples are aspirated into the monitor at either an adjustable or a fixed flow rate. while an underdose of agent will result in insufficient anesthesia. Most MMGMs measure concentrations of halogenated anesthetic agents. Each gas absorbs light at several wavelengths. in some MMGMs. Because they measure chemically diverse substances. the patient’s physiologic status must be continuously assessed and trends and sudden changes quickly identified. Nafion sampling lines that can connect to any monitor are also available from most monitor manufacturers or from independent sources. Most monitors eliminate the exhaust gas through a port on the rear of the unit that can be attached to a scavenging system or to the patient’s breathing circuit (in closed-loop systems). The light absorption in the analysis chamber is proportional to the partial pressure of the gas. Some deaths related to anesthesia use might be preventable with adequate respired and anesthetic gas monitoring in the OR. An overdose of anesthetic agent and/or too little O2 can lead to brain damage and death.Multiple Medical Gas Monitors. When IR ©2013 ECRI Institute. either an electrochemical (galvanic) cell or a paramagnetic sensor is typically used to measure respired O2 concentration. During general anesthesia. but only one absorption wavelength is selected for each gas to determine the gas concentration. typically from 50 to 250 mL/min. thereby reducing water vapor before the gas sample reaches the analysis chamber. and N2O using nondispersive IR absorption technology. Dual-chamber nondispersive IR spectrometers pass IR energy from an incandescent filament through the sample chamber and an identical but air-filled reference chamber. although some MMGMs require that the user select the halogenated agent being used or that the monitor be equipped with a special option to identify the halogenated agent. Water vapor can affect infrared [IR] spectrometric measurements. Lower rates minimize the amount of gas removed from the breathing circuit and therefore from the patient’s tidal volume; however. In most units. All Rights Reserved. MMGMs commonly combine more than one analytical method. verifies that the appropriate levels of delivered gases are administered. CO2. low sampling flow rates can increase the response time (rise time) and reduce the accuracy of measurements. The light is filtered after it passes through the chambers. (Nafion allows moisture to pass through the sampling line and into the atmosphere. Page 2 of 7 . Some MMGMs use a piezoelectric method to measure anesthetic agent concentration. Respired/Anesthetic Purpose ​MMGMs continuously sample and measure inspired and expired (end­tidal) concentrations of respiratory and anesthetic gases during and immediately following anesthetic administration. Gas monitoring provides the anesthetist with information about the patient’s physiologic status. the gases are automatically identified and quantified.) Some manufacturers use a water trap and/or filter to remove condensation from the sample. MMGMs display inspired/expired gas concentrations and sound alarms to alert clinical personnel when the concentrations of measured gases and the physiologic parameters fall outside set limits. which aspirate samples from the breathing circuit through narrow-diameter tubing that is usually made of polyvinyl chloride (PVC). and only the wavelength selected for each gas is transmitted to the detector.

3 µm— the peak wavelength at which the hydrogen-carbon bond absorbs light. and is carried by a reaction product to the other (reference) electrode. longer optical path within the MMGM that can accommodate the weaker signal generated by the halogenated anesthetics. and each gas absorbs the light differently in the selected wavelength bands. The temperature of the O2 affects the rate of its diffusion through the membrane and therefore the output of the cell. The sample is pumped through a chamber containing two crystals: a reference crystal and a second crystal that has been coated with an organophilic compound to adsorb the anesthetic gas. The sample and reference gases are pumped through these chambers to a common outlet. They have integral display capability and are also commonly Page 3 of 7 ©2013 ECRI Institute.Multiple Medical Gas Monitors. The reference crystal and microprocessor compensate for the effects of temperature and of atmospheric pressure variations. while other. O2 diffuses through a semipermeable membrane. Each of several filters (one for each anesthetic agent and one to provide a baseline for comparison) transmits a specific wavelength of IR light. however. The piezoelectric method measures the concentration of a selected halogenated agent. The design of paramagnetic sensors for measuring O2 concentration is based on the high degree of susceptibility of O2 (compared to other gases) to magnetic forces. Respired/Anesthetic spectrometry is used to determine halogenated agent concentration. The sensor consists of a symmetric cell with identical chambers for the sample and the reference gas (air) joined at an interface by a differential pressure transducer or microphone. the anesthetics are usually analyzed along a separate. and high agent concentrations. The resulting increase in mass changes the coated crystal’s resonant frequency in direct proportion to the concentration of anesthetic gas in the sample. and use single­channel. thereby generating a voltage that is displayed as the percentage of vapor. causing the transducer to produce a voltage proportional to the O2 concentration. Monitors that require the user to select the delivered agent to be measured use a wavelength range around 3. . where it frees electrons. Such MMGMs therefore cannot distinguish among the various halogenated agents or other molecules that contain carbon-hydrogen bonds. Some monitors also have alarms for system malfunctions such as disconnection (air leaks can often be identified from trending of O2 and CO2). high N2O. MMGMs typically display waveforms and trends. Some units. The user typically calibrates or verifies calibration of the MMGM with a standard gas mixture from an integral or external gas cylinder. apnea. and some is consumed through oxidation—and it eventually requires replacement. less critical audible alarms can be permanently silenced. occlusion. Monitors that can identify as well as quantify halogenated agents typically use a chamber separate from the one used for measuring CO2 and N2O. a thermistor incorporated into the cell compensates for temperature changes. the electrode loses water—some diffuses out as O2 enters the cell. All Rights Reserved. reaches a reducing electrode. In the galvanic cell. multiwavelength IR filter photometers. MMGMs are microprocessor controlled and have useradjustable alarms that typically include factory-preset default alarms and/or alarm-set programs for both high and low concentrations of the gases measured. A strong magnetic field surrounding the region just before the gases come together acts on the O2 molecules to generate a pressure difference between the two sides of the cell. Several factors affect the output and lifetime of the cells. provide an automatic-calibration feature. or inadvertent rebreathing. The rate at which O2 diffuses into the cell and generates voltage is directly proportional to the partial pressure of O2 diffusing through the membrane. measure absorption in the 7 to 14 µm range. MMGMs typically have a method for temporarily silencing audible alarms for low O2. During its life.

4 volume %. such leaks can often be identified from changing O2 and CO2 trends. whichever is greater. 0-100% oxygen with an accuracy of 5% of reading or 2 volume %. 0-20% desflurane with an accuracy of 0. ©2013 ECRI Institute. thereby diluting the delivered gas concentration. 0-6% enflurane with an accuracy of 0. or in a patient’s breath can cause inaccurate concentration readings on monitors that cannot distinguish these compounds from anesthetic agents. The presence of alcohol or other organic vapor in the room.25 volume %. The MMGM should display inspired and expired gas concentrations of CO2 and halogenated agent. and respiration rate. Clinical personnel must be relied on to fill the vaporizers with the proper agent (a keyed filling system will help prevent errors) and to connect the breathing circuit correctly to preclude accidental use of the wrong or multiple anesthetics. however. Many units provide a graphic display of breath-by-breath concentrations and a hard copy of trends of gas concentrations from the beginning to the end of the anesthesia event. Page 4 of 7 . and volume monitoring. 0-80% nitrous oxide with an accuracy of 10% of reading or 5 volume %. whichever is greater. some manufacturers still recommend periodically cleaning the chamber. 0-10% carbon dioxide with an accuracy of 10% of reading or 0. Monitors should accurately measure gas concentration over the range that is encountered clinically and should compensate for the interference effects between gas constituents. whichever is greater. Some monitors circumvent this problem by trapping condensate before it reaches the chamber. 0-6% isoflurane with an accuracy of 0. The device may also include monitoring of other variables such as oxygen saturation (SpO2). MMGMs that both identify and quantify halogenated agents can eliminate interference from these compounds because these monitors measure concentrations of halogenated agents at a wavelength where organic vapors do not have a peak in the IR absorption spectrum. The presence of nitrogen (N2) in the inspired gases indicates that air is being aspirated into the breathing circuit. Although most MMGMs do not monitor N2 concentration. in a sample line. 0-10% sevoflurane with an accuracy of 0. The MMGM should continuously sample and measure inspired and expired concentrations of respiratory and anesthetic gases during and immediately following anesthetic administration. the user must set the agent selection control according to the halogenated anesthetic being used. All Rights Reserved.25 volume %. Reported Problems The accumulation of water-vapor condensation or other materials in the sampling chamber can interfere with the accuracy of MMGMs. such as chart recorders and printers. airway pressure. particularly to prevent the accumulation of secretions or other foreign matter. Purchase Considerations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for MMGMs. while others use special tubing (Nafion) and hydrophobic filters to prevent water vapor from affecting monitor performance.25 volume %. For MMGMs that cannot identify halogenated agents.25 volume %. The range that a monitor should be able to measure and the accuracy that it should achieve for each of the analyzed gases should be as follows: 0-6% halothane with an accuracy of 0. Respired/Anesthetic equipped with output jacks to interface with computerized anesthesia record-keeping systems or with additional analog and/or digital display units. inspired (or mean) concentrations of O2 and N2O.25 volume %.Multiple Medical Gas Monitors.

Users may want to check the availability of service and the repair turnaround time before selecting multigas monitors for their facilities. or pressure in the breathing circuit should be eliminated or automatically compensated for by the MMGM. The MMGM should display the CO2 waveform. A facility should consider the status of its present physiologic monitoring system before purchasing an MMGM. and agent monitoring and/or for pulse oximetry.e. the actual alarm-limit setting should not be altered. For example. MMGMs can also be integrated into anesthesia delivery units. It is preferable that the unit allow the user to select at least two additional graphical displays (e. Performance should not be affected by attachment to a scavenger. It should not be possible to indefinitely silence the apnea alarm. 25 breaths/min for adults and up to 60 breaths/min if the monitor is intended for neonatal or pediatric applications). If a facility is planning to replace its current anesthetic delivery equipment. For safe.g. Agent monitoring should activate automatically when the unit is turned on. Manufacturers should provide tubing (of a smaller diameter than the breathing circuit) with the appropriate fittings to connect the exhaust port to the expiratory breathing circuit (22 mm tee) or a scavenger (19 mm tee). units should meet several minimum critical alarm criteria: The apnea alarm (associated with CO2 monitoring) and the low O2 alarm limit are critical in all situations and should be impossible to disable while a patient is connected. Page 5 of 7 ©2013 ECRI Institute. Other considerations MMGMs are produced as either a configured unit or a modular part of a physiologic monitoring system. effective monitoring. For low O2. an easy-to-access port to which the sampling tube cannot be connected should be provided with the monitor.. Monitors should allow flexibility in setting alarm limits and help minimize the use of inappropriate settings. When gas is to be scavenged.. To achieve the degree of accuracy and performance reliability necessary for anesthetic monitoring. if a hospital has pulse oximeters. Alarm limits should be easy to review and set. All Rights Reserved. The anesthetist should be able to view all alarm limits and gas concentration displays simultaneously while reviewing and setting alarm limits. and preferably. The MMGM should remain zeroed and calibrated for at least six months. and the alarm limits should be easy to review on a single screen. Measurements should remain accurate over commonly used ventilation rates (i. Respired/Anesthetic Interference with measurements caused by the presence of water vapor. If the displayed CO2 concentration is changed between mm Hg and percent CO2. Alarms should be available for all parameters that the MMGM monitors.Multiple Medical Gas Monitors. A modular MMGM may allow all information and alarms to be integrated into one display. It is acceptable. for the unit to require that agent be selected before monitoring begins. it should not be possible to lower alarm limits to values that are not clinically useful (minimum settings of 18%). aspirated fluid. Exhaust gas from the MMGM must be returned to the patient’s breathing circuit or scavenged. the alarm limit will be converted into the new units. . N2O. The variety of MMGM configurations available permits a facility to add modules to expand the capabilities of its monitoring equipment. it may want to consider an anesthesia system with optional modules for combined CO2. provided that the unit warns the user when agent is detected but has not been selected. MMGMs require careful maintenance by qualified biomedical engineering personnel. The unit should alarm to indicate an occluded sampling line or a system failure. it can purchase units without the pulse oximeter option. however. waveforms and trends).

Bibliography Ansermino JM. as well as features that improve the energy efficiency of their products or make them more recyclable. More recently. Nilsson K. some monitors are made from nonferrous materials and are marketed for use during magnetic resonance imaging procedures. Last updated February 2011 ©2013 ECRI Institute. Hosseini N. J Clin Monit Comput 2010 Apr. Patient monitoring with head-mounted displays. Jenkins SA. Respired/Anesthetic Environmental considerations As a result of increasing concerns over the environment and the conservation of resources. they have been adapted for respiratory monitoring of CO2. et al. Use of audio signals derived from electroencephalographic recordings as a novel ‘depth of anaesthesia’ monitor. many manufacturers have adopted green shipping and production methods. Berggren M. Introduction of new monitors into clinical anesthesia. Curr Opin Anaesthesiol 2009 Dec. Ostblom J. Ansermino JM. Stage of Development IR analyzers have been used for many years to identify and assay compounds for research applications. Daniels JP. it also has a built-in pulse oximeter. If a supplier does not offer such an arrangement. Glen J.108(3):873-80. Med Hypotheses 2010 Aug 19. Melo MF. Introduction of new monitors into clinical anesthesia.50(9):921. the facility must absorb the costs of disposing the system according to local environmental protection laws when it is replaced. An evaluation of a novel software tool for detecting changes in physiological monitoring. A monitor using IR photoacoustic technology has been developed that can quantify all commonly respired/anesthetic gases except N2 and water vapor.107(3):749-50. Facilities should look for manufacturers who offer take-back programs on system equipment. Improved response time with a new miniaturised main-stream multigas monitor.22(6):775-81. Singapore Med J 2009 Sep. Alarms alert OR personnel in the event of gas concentration delivery outside the set limits. Hewgill RT. healthcare facilities and device manufacturers have begun to adopt green initiatives that promote building designs and work practices that reduce waste and encourage the use of recycled materials. Daniels JP. Liu D. N2O.Multiple Medical Gas Monitors. Sanderson PM. Anesth Analg 2008 Sep. Anaesthetic gas monitoring comparison between two side-stream monitors.23(6):355-61. Page 6 of 7 . In addition. and halogenated agents. In addition. All Rights Reserved.22(6):796-803. Misleading display of haemodynamic and respiratory parameters: frozen monitor. et al. Leone. Anesth Analg 2009 Mar. Curr Opin Anaesthesiol 2009 Dec. Heijbel H. Some instruments are now designed to both identify and quantify specific agents. Garg R. BJ. et al. Brattwall M. J Clin Monit Comput 2009 Dec.24(2):169-72. like some other MMGMs.

org. More than 5.org (e-mail). performance. Need to Know More? For further information about the contents of this Product Comparison. For more information. Department of Health and Human Services. correspondence and discussion with manufacturers and distributors. specifications from product literature. All Rights Reserved. and drug technology. contact the HPCS Hotline at +1 (610) 8256000. Employees engage in no private consulting work for the medical device industry.Multiple Medical Gas Monitors. visit http://www. While these data are reviewed by qualified health professionals. The Healthcare Product Comparison System and ECRI Institute are not responsible for the quality or validity of information derived from outside sources or for any adverse consequences of acting on such information. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. As pioneers in this science for more than 40 years. +1 (610) 834-1275 (fax). they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. nor do they own stock in medical device companies. . or hpcs@ecri.000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement. dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. devices. healthcare processes. in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality. Respired/Anesthetic Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute. or the use of a photograph thereof. ext.g. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. trademarks). or of claims made for it by the manufacturer. and ECRI Institute’s Problem Reporting System. The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature. even though no reference to this fact may be made. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e. a nonprofit organization.. ECRI Institute marries experience and independence with the objectivity of evidence-based research. 5265. ECRI Institute and its employees accept no royalties. About ECRI ECRI Institute. gifts. or commissions from the medical device industry.S. or value. The information and photographs published in Product Comparisons appear at no charge to manufacturers. Page 7 of 7 ©2013 ECRI Institute.ecri. The appearance or listing of any item. risk and quality management. ECRI Institute respects and is impartial to all ethical medical device companies and practices. ECRI Institute is one of only a handful of organizations designated as an Evidence-based Practice Center by the U. a nonprofit organization. finder’s fees.S. procedures. Agency for Healthcare Research and Quality and is listed as a federal Patient Safety Organization by the U.

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