Anesthesia Units

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 Anesthesia Units Scope of this Product Comparison This Product Comparison covers complete anesthesia systems capable of delivering anesthetic agents, ventilating the patient, and monitoring ventilation variables (and possibly gas and physiologic variables). Excluded are separate analyzers designed to measure concentrations of halogenated anesthetics and gases supplied to the unit or to detect levels present in the operating room; also excluded are separate stand-alone physiologic monitoring systems. For information on these devices, see the following Product Comparisons:   

Multiple Medical Gas Monitors, Respired/Anesthetic Oxygen Monitors Physiologic Monitoring Systems, Acute Care; Neonatal; ECG Monitors; Monitors, Central Station These units are also called: anesthesia machines.

Purpose Anesthesia units dispense a mixture of gases and vapors and vary the proportions to control a patient’s level of consciousness and/or analgesia during surgical procedures. Anesthesia units primarily perform the following four functions:  

Provide oxygen (O2) to the patient Blend gas mixtures, in addition to O2, that can include an anesthetic vapor, nitrous oxide (N2O), other medical gases, and air  Facilitate spontaneous, controlled, or assisted ventilation with these gas mixtures  Reduce, if not eliminate, anesthesia-related risks to the patient and clinical staff The patient is anesthetized by inspiring a mixture of O 2, the vapor of a volatile liquid halogenated hydrocarbon anesthetic, and, if necessary, N 2O and other gases. Because normal breathing is routinely depressed by anesthetic agents and by muscle relaxants administered in conjunction with them, respiratory assistance—either with an automatic ventilator or by manual compression of the reservoir bag—is usually necessary to deliver the breathing gas to the patient.

Principles of operation An anesthesia system comprises three basic subsystems: a gas delivery platform, which creates and delivers gas mixtures and monitors the patient’s respiration (e.g., rate, airway pressure); a data analysis and distribution system, which includes hardware and software that collect and process data and display it to the clinician in a meaningful way; and, physiologic and multigas monitors (optional in most units), which

UMDNS Information This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Anesthesia Units [10-134]

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units indicate levels and variations of several physiologic variables and parameters associated with cardiopulmonary function and/or gas and agent concentrations in breathed-gas mixtures. Manufacturers typically offer a minimum combination of monitors, alarms, and other features that customers must purchase to meet standards and ensure patient safety. To meet the minimum standard of care in the United States, the American Society of Anesthesiologists (ASA) states that anesthesia systems must continually monitor the patient’s oxygenation, ventilation, circulation, expired CO2 levels, and temperature. Integrated or stand-alone monitors may be used.

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Gas supply and control Because O2 and N2O are used in large quantities, they are usually drawn from the hospital’s central gas supplies. Cylinders containing compressed O2, N2O, and sometimes other gases are mounted on yokes attached to the anesthesia machine and can serve as an emergency gas supply in case central supplies fail. Cylinder connections should include indexing systems (e.g., specific pattern of pins), which are intended to prevent accidental mounting of a gas cylinder on the incorrect yoke. Each gas entering the system from a cylinder flows through a filter, a oneway check valve, and a regulator that lowers the pressure to approximately 45 pounds per square inch (psi). There is no need for a separate regulator when the central gas supply is used because the pressure is already at about 50 psi. Anesthesia machines have an O2-supply-failure device and an alarm that protect the patient from inadequate O2 supply. If the O2 supply pressure drops below about 25 to 30 psi, the unit decreases or shuts off the flow of the other gases and activates an alarm. The flow of each gas in a continuous-flow unit is controlled by a valve and indicated by a flowmeter. The flowmeter can be a purely mechanical arrangement, with a flow tube in which a bobbin moves up and down depending on the flow, or it can be an electronic sensor with an LCD (liquid crystal display). After the gases pass through the control valve and flowmeter, enter the low-pressure system, and, if required, pass through a vaporizer, they are administered to the patient. The N 2O and O2 flow controls are interlocked so that the proportion of O2 to N2O can never fall below a minimum value (generally 0.25) to produce a hypoxic breathing mixture. An O2 monitor that is located on the inspiratory side of the breathing circuit analyzes gas sampled the patient’s breathing circuit and displays O 2 concentration in volume percent. O2 monitors should sound an alarm if the O2 concentration falls below the preset limit. If the flow of anesthetic gases to the patient must be interrupted for any reason, an O 2 flush valve can be activated to provide a large flow of central-source O2 to purge the breathing circuit of anesthetic vapors. The O2 flush flow bypasses the flowmeters and vaporizers.

Vaporizers Because the inhaled anesthetic agents, with the exception of N 2O, exist as liquids at room temperature and sealevel ambient pressure, they must be evaporated by a vaporizer. Vaporizers add a controlled amount of anesthetic vapor to the gas mixture. Units capable of accommodating more than one vaporizer at a time (some accept as many as three) should have a lockout mechanism that prevents the use of more than one vaporizer at once. Most vaporizers are either variable bypass (conventional) or heated blender. A few anesthesia units now have a liquid-injector type of vaporizer. This vaporizer is electronically controlled and injects the liquid anesthetic agent directly into the stream of gases.

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Anesthesia Units

Figure 1. Continuous-flow anesthesia system

Variable bypass and heated blender vaporizers are concentration calibrated and thus can deliver a preselected concentration of vapor under varying conditions. In a variable bypass vaporizer, such as one used for enflurane, isoflurane, halothane, or sevoflurane, a shunt valve divides the gas mixture entering the vaporizer into two streams; the larger stream passes directly to the outlet of the vaporizer, while the smaller stream is diverted through an internal chamber in which vapor fills the space over the relatively volatile liquid anesthetic. The vapor mixes with the gas of the smaller stream, which then rejoins the larger stream as it exits the vaporizer. In a mechanically-controlled variable-bypass vaporizer, a bimetallic thermal sensor that regulates the shunt valve to divert more or less gas through the chamber compensates for temperature changes that affect the equilibrium vapor pressure above the liquid. Each variable bypass vaporizer is specifically designed and calibrated for a particular liquid anesthetic. The heated blender vaporizer was introduced for use with the anesthetic agent desflurane. In this type of vaporizer, desflurane is heated in a sump chamber. A stream of vapor under pressure flows out of the sump and blends with the background gas stream flowing through the vaporizer. Desflurane concentration is controlled by an adjustable, feedback-controlled metering valve in the vapor stream. Measured-flow vaporizers (also known as copper kettle or flowmeter-controlled) are considered largely obsolete but may still be in limited use in some developing countries. These vaporizers are not concentration calibrated; instead, a measured flow of carrier gas is used to pick up anesthetic gas. Draw-over vaporizers are sometimes used by the military in the field, as well as in situations or countries in which pressurized gas sources are unavailable. Such units offer low resistance to gas flow and are relatively simple

Ventilation Manual ventilation, which requires that an operator manually squeeze the reservoir bag for each patient breath, can be tiring during long procedures and can compete with other tasks; therefore, an automatic ventilator is generally used to mechanically deliver breaths to the patient. These ventilators use a bellows or piston in place of the manually-compressed reservoir bag. The ventilator forces the anesthesia gas mixture into the patient’s breathing circuit and lungs and, in a circle breathing system, receives exhaled breath from the patient as well as fresh gas. The anesthetist can vary the volume of a single breath (tidal volume) and the ventilation rate, either directly by setting them on the ventilator or indirectly by adjusting parameters such as the duration of inspiration, the inspiratory flow, and the ratio of inspiratory to expiratory time. The ventilatory pattern is adjusted to the varying needs of the patient. ©2008 ECRI Institute. All Rights Reserved

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Minute ventilation, the total volume inspired or expired during one minute, can be evaluated as the product of the expired tidal volume and the ventilation rate. It requires careful monitoring, not only because it is physiologically important to the patient, but also because it can indicate malfunctions of the ventilation delivery system (e.g., leaks in the breathing circuit). The expired tidal volume can be measured with a flowmeter, with a spirometer, or (most commonly) with a sensor placed in the expiratory circuit. Most ventilators are capable of providing controlled ventilation and can maintain a positive airway pressure during the expiratory phase of the breath (positive end-expiratory pressure [PEEP]). Many ventilators can be equipped with modes that permit spontaneous breathing during mechanical ventilation.

Breathing circuits Most anesthesia systems are continuous-flow systems (see Figure 1), that provide a continuous supply of O2 and anesthetic gases. There are two basic types of breathing circuits used in these systems: the circle system and the T-piece system (see Figure 2), each of which can assume various configurations. (A common configuration of the T-piece system is the Bain modification of the Mapleson D system.) A higher proportion of anesthetic gases is rebreathed in the circle system, which uses check valves to force gas to flow in a loop and returns expired gases (minus the CO2), plus fresh gas, to the patient. In the T-piece circuit, most of the exhaled gas is vented out of the system, and the portion rebreathed depends on the fresh-gas flow rate.

Figure 2. Examples of breathing circuits

In the circle system, fresh gas from the anesthesia machine enters the inspiratory limb of the breathing circuit and mixes with gas in the system before the resulting mixture flows through a one-way valve to the patient. Expired gas flows from the patient through a second (expiratory) limb of the circuit, passing another one-way valve, into either a reservoir bag or a ventilator. When positive pressure is generated in the system, either by a manual squeeze of the reservoir bag or by compression of the bellows or piston by a mechanical ventilator, collected gas that does not escape via an adjustable pressure-limiting (APL) valve to the scavenging system is driven through a CO2 absorption canister where CO2 is removed from the gas before it is returned to the patient. In circle breathing systems, a fresh-gas flow of 1 L/min or less is typically considered low-flow anesthesia (4 to 10 L/min is typically considered the usual fresh-gas flow rate). A fresh-gas flow of 0.5 L/min is generally considered minimal-flow anesthesia. In situations in which the cost of anesthetic agents is high, low-flow anesthesia may be the preferred option.

Machines with a T-piece design have corrugated tubing in which fresh gas and some expired gas mix before entering the patient at each inhalation. Partial rebreathing is controlled by the supply rate of fresh gas, and the exhaled anesthetic mixture leaves the circuit through an APL valve. Elimination of rebreathed CO 2 depends on fresh-gas flow and occurs in direct proportion to that flow. This system, although adaptable to a variety of anesthetic procedures, is used most often in pediatric anesthesia. Circle systems offer advantages over T-piece systems in that they conserve a greater proportion of the anesthetic gases and conserve body heat and moisture from the patient. The advantages of T-piece systems

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units include a lower circuit compliance, easier circuit sterilization (when reusable circuits are used), and a less complex design requiring fewer valves and no CO2 absorber (although one can be used with it).

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Because excess pressure imposed on the patient’s lungs can cause serious lung damage, either an APL valve (during manual ventilation) or a valve in the ventilator (during automatic ventilation) allows excess gas to escape when a preset pressure is exceeded. There are two types of APL valves: spring-loaded and needle valves. The spring tension in spring-loaded APL valves can be adjusted to control the pressure at which the valve will open. At lower pressures, the valve is closed. The pressure in the breathing system maintained by the needle valve depends on the flow through the valve. Therefore, when the valve is not fully closed, gas will always leak from the system. The minimum exhaust pressure required to refill a ventilator bellows is usually 1 to 2 cm H 2O; for maximum pressure, both types of valve are fully closed. Because many APL valves do not have calibrated markings, the anesthetist must adjust them empirically to give a desired peak inspired pressure. Circle systems and T-piece systems also include a pressure gauge for monitoring circuit pressure and setting the APL valve. An electronically controlled, settable, and calibrated APL valve is available on some anesthesia machines.

Scavenging system A scavenging system captures and exhausts waste gases to minimize the exposure of the operating room staff to harmful anesthetic agents. Scavenging systems remove gas by a vacuum, a passive exhaust system, or both. Vacuum scavengers use the suction from an operating room vacuum wall outlet or a dedicated vacuum system. To prevent positive or negative pressure in the vacuum system from affecting the pressure in the patient circuit, manifold-type vacuum scavengers use one or more positive or negative pressure-relief valves in an interface with the anesthesia system. In contrast, open-type vacuum scavengers have vacuum ports that are open to the atmosphere through some type of reservoir; such units do not require valves for pressure relief. Passive-exhaust scavengers can vent into a hospital ventilation system (if the system is the nonrecirculating type) or, preferably, into a dedicated exhaust system. The slight pressure of the waste-gas discharge from the anesthesia machine forces gas through large-bore tubing and into the disposal system or directly into the atmosphere.

Monitors and alarms Anesthesia systems incorporate a set of equipment-related monitors, including those for airway pressure, expiratory volume, and inspired O2 concentration. They can also include exhaled gas monitors, such as those for CO2 concentration, N2O concentration, and agent concentration, or physiologic monitors such as those for blood O2 saturation by pulse oximetry, electrocardiogram, invasive and noninvasive blood pressure, and temperature. Anesthesia systems are typically configured with respect to their monitors in one of two ways: as modular systems or as preconfigured systems. In the modular approach, an anesthesia machine with a basic set of equipment monitors (usually airway pressure, inspired O2 concentration, and expired volume) is used as a physical platform for the system. Additional physiologic monitors, individually or in a monitoring system (with its own display and alarms), along with other devices as needed, are obtained separately and added to the system. The preconfigured approach involves a more completely integrated, manufacturer-assembled system that already includes all physiologic and equipment monitors and displays in a turnkey unit. Integration of the information and alarms from each of the monitors into as few displays as possible (preferably 1 or 2) has become very important. An integrated display gives the anesthetist a single point of reference for a wide variety of equipment and physiologic information. Anesthesia machines that lack integrated alarms can sometimes cause confusion among anesthetists and operating room teams by sounding numerous alarms simultaneously. In an integrated system of information and alarms, visual alarm messages appear on a central display; furthermore, audible and visual alarms are prioritized so that the more urgent alarm sounds and visual signals are associated with the more vital monitored variables.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units An anesthesia workstation is designed to centralize system control and to integrate the display of information. This involves continuous acquisition, recording, and presentation on a central display of selected monitored physiologic and equipment variables (in real time or using historical trends) along with limit settings and the status of all alarms, plus explanatory messages.

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Several models exist to predict the level of wakefulness in anesthetized patients, such as the Ramsay Scale and the Modified Observer’s Assessment of Alertness/Sedation Scale. However, in lieu of a direct method of monitoring brain activity during surgery, users may rely on indirect means of assessing consciousness, such as blood pressure and vital signs. According to proponents, one indirect method, level-of-consciousness monitoring (e.g., Bispectral Index [BIS], Physiometrix’s Patient State Index), measures the effectiveness of painkilling agents while ignoring the sedative and paralytic elements that constitute a significant portion of anesthetic agents. Some anesthesia units may incorporate this technology as an additional tool to monitor the patient. Level-ofconsciousness monitors use a metered scale (0 to 100) to indicate the degree of patient wakefulness based on collected and processed data. A digital meter indicates the number on the scale that corresponds to the patient’s degree of wakefulness, with a higher number representing a higher degree of consciousness and awareness of sensation despite the presence of anesthetic agents. One supplier offers an Entropy module that provides information on the central nervous system during general anesthesia. The information is acquired based on the acquisition and processing of raw electroencephalogram (EEG) and frontalis electromyography (FEMG) signals using a proprietary algorithm. The Entropy module is designed to assist clinicians in delivering the appropriate amount of anesthetic agents. ASA states that there is not enough evidence to warrant mandatory use of these technologies for patients under general anesthesia. However, ASA states that it may be useful for at-risk patients to be monitored for intraoperative awareness. For additional information, visit ASA’s Website at http://www.asahq.org/publicationsAndServices/AwareAdvisoryFinalOct05.pdf.

Automated anesthesia record keepers/anesthesia information management systems Automated anesthesia record keepers (AARKs) are available either as an option on some anesthesia units or from third-party suppliers. They are used for collecting data from electronic ventilation and monitoring equipment that has appropriate outputs. Vital signs such as blood pressure, heart rate, end-tidal CO2, and oximeter values are recorded at specific intervals and plotted in graph form. Drug dosages, lab data, intraoperative events, and gas delivery rates are entered into the system either manually or by some semiautomated means; comments can also be entered directly onto the record. An AARK produces a formatted hard copy of the anesthesia record for the patient’s files. Gathering and storing such data can expedite individual patient management and billing, quality assurance, critical incident analysis, and teaching. However, automated record keeping has not achieved wide acceptance, in part because of many clinicians’ concerns about misleading artifacts being entered into the record, hospital personnel’s resistance to change, and the cost of implementing an automated record keeper. An anesthesia information management system (AIMS) can receive, analyze, store, and distribute information relating to the clinical and administrative management of anesthesia. Information can be collected from numerous sources associated both directly with anesthesia administration (e.g., an AARK system) and indirectly with the surgical procedure (e.g., preoperative evaluation, laboratory, and pharmacy records). Long-term storage capabilities aid in quality assurance and anesthesiology research. Some systems may also incorporate administrative management tools such as room scheduling and patient billing. (For further information, see the Product Comparison titled Data Management Systems, Anesthesia)

Reported problems Problems have been reported in all areas of anesthesia systems. Because patients under general anesthesia depend entirely on others for life support, errors caused by machine failure, faulty adjustments, or the operator 6

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units can be critical. Pre-use checklists, regular inspections, and preventive maintenance are critical to minimizing anesthesia unit hazards.

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One of the greatest dangers of general anesthesia is a lack of O 2 delivered to the patient (hypoxia), which can result in brain damage or death. Conversely, the administration of O 2 in a concentration of 100%, even for a short duration, may be toxic. Inhalation of 100% O2 may cause resorption atelectasis. The danger of inhaling 100% O 2, even for a short duration, is particularly acute in neonatal anesthesia, potentially causing retrolental fibroplasia and bronchopulmonary dysplasia. Inadequate O2 delivery can be caused by any number of conditions, including disconnection of the patient from the breathing circuit; accidental movement of the O 2, N2O, or other gas flow control setting knobs; changes in the patient’s lung compliance; and gas leaks. One common safety measure is the inclusion of an O2 monitor and a CO2 monitor or an expired volume alarm (in an anesthesia unit with an ascending bellows) in the anesthesia system. An O2 monitor warns of inadequate O2 concentration in the inspiratory limb. A CO2 monitor or a spirometer alarm (in an anesthesia unit with an ascending bellows) in the breathing circuit can alert the anesthetist to inadequate ventilation such as that caused by a disconnection. ECRI Institute has investigated incidents of patient exposure to carbon monoxide (CO) during the administration of inhaled anesthetics through semiclosed circle anesthesia systems. Once in the blood, CO binds tightly with hemoglobin, forming carboxyhemoglobin and diminishing the ability of hemoglobin to transport and release O2. A reaction between halogenated anesthetic agents and commonly used CO 2 absorbents can produce CO if the CO2 absorbent is excessively dry. Excessive dryness can occur when (1) an anesthesia machine has been idle (e.g., over a weekend) and (2) there is a continuous flow of medical gas (which is very dry) through the CO 2 absorber. When dry, the absorbent becomes highly reactive in the presence of certain halogenated agents, resulting in the production of CO as the agent flows through the machine’s CO2 absorber. ECRI Institute recommends that the absorbent material in both canisters of an absorber be replaced whenever there is reason to believe that a machine has been left idle with gas flowing for an undetermined time. Fresh absorbent materials are sufficiently hydrated and normally remain hydrated by exhaled water vapor in the circle system, thereby preventing reaction with halogenated agents. For more information, see the Health Devices citation in this report. Some anesthesia system malfunctions can cause delivery of gas with excessive CO2 concentration, an inadequate or excessive amount of anesthetic agent, or dangerously high pressure. Hypoventilation, compromised cardiac output, air in the pleural cavity (pneumothorax), and asphyxiation are possible consequences of such problems. Improperly calibrated vaporizers can result in the delivery of the wrong concentration of anesthetic agent to the patient. Removing some vaporizers from the anesthesia machine and transporting them can disturb their calibration and could eventually cause delivery of too much or too little anesthetic. However, many “tip-proof” vaporizers have been released to reduce calibration errors. The output of an anesthesia vaporizer should be tested each time the vaporizer is removed from a system and each time it is returned to service. Each vaporizer should be inspected and the calibration verified at least twice a year. Contamination of any part of the anesthesia breathing circuit, including the breathing tubes, Y-connector, face mask, and reservoir bag, may lead to nosocomial infections. Reported cases include infections of the upper respiratory tract or the lungs and, in one instance in Australia, transmission of hepatitis C. The Centers for Disease Control and Prevention (CDC) and the American Association of Nurse Anesthetists recommend single use of disposables or high-level disinfection of reusables or disposables between patients to prevent crosscontamination. There has been some controversy concerning the use of disposable bacteria filters to prevent patient cross-infections (Berry and Nolte 1991, Brooks et al. 1991, Dorsch and Dorsch 1998, Hogarth 1996, Komesaroff 1996, Snowdon 1994). CDC has not made a definitive recommendation concerning the use of bacterial filters with anesthesia machines. Possible hazards, such as the increased impedance to gas flows and obstruction of the circuit, are associated with these filters. Because many viruses are difficult to culture, the efficacy of viral filters that attempt to reduce viral contamination of breathing systems is not established. Frequent replacement of disposable filters can prevent inadequate gas delivery due to clogging. Some filters can be sterilized and reused.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units The piping connections for O2 and N2O within the hospital walls can be accidentally interchanged during installation or repair of medical gas systems, potentially causing patient injury or death. After any such work, careful inspection and testing with an O2 analyzer are vital. Gas lines should also be checked for liquid, gaseous, solid particulate, and microorganism contamination after installation or repair and periodically thereafter.

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In many countries, a diameter index safety system (DISS) is used to prevent the connection of gas hoses from the machine to the wrong wall outlet, and a pin index safety system is used to prevent the connection of the wrong cylinders to the yokes in the anesthesia machine. The pin index safety system employs pins protruding from the yoke that correspond to holes in a specific type of gas cylinder post. Only a cylinder post with the corresponding holes can fit properly onto the yoke. ECRI Institute has seen instances of improper connections in which damaged pins allowed users to force the wrong cylinder into place. ECRI Institute recommends that damaged indexing components should never be used. Faulty or inoperative scavenging systems are responsible for most anesthetic gas pollution in the operating room; other causes include improper anesthesia administration technique and leaks in anesthesia equipment. Common sources of leaks include hose connectors, the CO2 absorber, the APL valve, and the endotracheal tube or mask. Current scientific and epidemiologic studies have shown that exposure to trace levels of anesthetic gases continually present in the operating room can cause adverse health effects in operating room personnel, such as an increased incidence of spontaneous abortion and congenital anomalies in offspring. In addition, trace gas levels in the air may have a slight anesthetizing effect on the anesthetist and surgeon. Inadequate evacuation of some scavenging systems can cause pressure to build up in the breathing circuit, with the potential for pneumothorax. Another common problem is circuit obstruction due to the presence of a foreign object (e.g., needle caps) or a manufacturing defect. This problem occurs most often when a pre-use check is omitted. As mentioned previously, anesthesia units that lack integrated monitors and alarms can cause confusion by sounding numerous alarms simultaneously. While integrated monitors and alarms are becoming more widespread, both modular and integrated systems are subject to the confusion caused by false alarms. A false alarm, caused by accidental patient movement or other nonphysiologic reasons, can confuse operating room staff and possibly draw attention away from other alarms that may truly indicate a change in the patient’s physiologic condition. Ensuring that the alarm limits are properly set and positioning sensors and electrodes in such a way as to minimize artifacts can reduce the incidence of false alarms. ECRI Institute recommends that users do not set physiologic alarm limits below normal values in order to reduce nuisance alarms. The magnetic fields created by magnetic resonance imaging (MRI) equipment may interfere with the function of conventional anesthesia units and electronic monitoring equipment when used in proximity to such equipment. Conversely, magnetic materials and electronic monitors may interfere with MRI scanner function and degrade image quality. Many MRI-compatible anesthesia machines have restrictions or limitations to their use in the MRI environment. If they are not used in accordance with these restrictions/limitations, MRI-compatible devices can pose the same types of hazards in the MRI environment as devices that are not MRI compatible. For instance, if some MRI-compatible devices are positioned closer to the MRI unit than is specified by the device supplier, they may not function properly or be attracted to the magnet. Some MRI-compatible devices that come into physical contact with a patient, if used inappropriately, can cause burns (or the sensation of heat) to a patient. The hazards posed by the inappropriate use of MRI-compatible devices in the MRI environment can cause injury to the patient or staff and/or damage to equipment (e.g., the MRI-compatible device, the MRI unit itself). A few suppliers offer MRI-compatible anesthesia machines, and a line of MRI-compatible monitors is available.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Purchase considerations ECRI Institute recommendations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for anesthesia units. The recommendations are listed in two categories: basic and high performance.

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ECRI Institute considers certain minimum safety measures necessary for all anesthesia units. Among these measures are O2 fail-safe and hypoxic mixture fail-safe systems, gas cylinder yokes for O2 if central supplies fail, and an internal battery (for units with automatic ventilators) capable of powering the unit for at least 30 minutes. The unit must be able to measure O2 concentration, airway pressure, and either the volume of expired gas or the concentration of expired CO2 (ETCO2). (Note: ASA recommends monitoring of ETCO2 in all intubated patients; this can be accomplished by the anesthesia unit or by a separate device [e.g., capnograph, multigas monitor].) Gas cylinders should be attached through hanger yokes with the proper pin index safety system and check valves. Each pipeline gas cylinder supply should have a pressure gauge with scale numbers large enough to be easily read. Gas hoses and machine receptacles should use DISS fittings to prevent misconnection. It is advantageous if the anesthesia unit accepts medical-air input to allow delivery of either air and/or N2O as the gas carrier. In the event of a partial or complete loss of O 2 supply, an undefeatable audible alarm should activate and the flow of N2O gases should automatically shut off or decrease proportionately to the flow of O2 to prevent a hypoxic condition. Also, flows and the mixture ratios determined from flowmeter settings should be accurate to within 10% of set values. Anesthetic vapor concentration delivered to the common gas outlet should be accurate to within 0.2% vapor concentration of agent or 10% of the set value (whichever is greater) at any gas flow. It is preferable that ventilation rate and PEEP values be monitored. It should not be possible to silence or disable a ventilator monitor alarm for longer than two minutes. Units should have a power-loss alarm, and the battery backup should have an automatic low-battery alarm. All units should include a backup battery to guard against power loss. The anesthesia unit should automatically switch to the internal battery if line power is interrupted; also, the loss of line power should be accompanied by an alarm. The battery should also operate the anesthesia unit and integral monitors for at least 30 minutes. A lowbattery alarm should visually and audibly indicate when the battery voltage falls to a level below which the unit may fail to perform satisfactorily. The battery should not require more than 16 hours to recharge completely after depletion. High-performance systems are distinguished largely by their ability to serve a wide range of patients and to operate with little or no supplemental equipment. Features that make this possible include ventilator modes and tidal volume ranges suitable for neonates and adults, as well as integrated gas and sometimes physiologic monitoring. (Although most models tend to include only a small number of standard ventilation modes, additional modes can typically be added via software upgrades following purchase.) High-performance units generally include more automated features, including storage of trends and self-tests at the beginning of each procedure. Basic systems include only the most vital monitoring capabilities (i.e., O 2 and CO2 volumes or pressures) and have only one or two automatic ventilator modes. When equipped with appropriate stand-alone monitors, these units are adequate for treatment of most patients but may remain ill-suited for use on neonates and very sick patients, as well as for monitoring-intensive procedures (e.g., certain types of cardiac surgery). These fundamental systems may also include units designed for military or field use, which often lack ventilators and pipeline gas inlets.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Other considerations Some anesthesia units require stand-alone physiologic monitors (modular approach) and/or anesthetic agent monitors, while others have integrated monitors (preconfigured approach). The advantages of preconfigured monitoring include convenience and electronically integrated displays and prioritized alarms. Modular systems can be less expensive than preconfigured systems, especially if the facility already owns the monitors.

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Hospitals can purchase customized modular systems assembled from standard components, or they can assemble their own modular systems. These systems must meet all national and regional safety standards. Advantages of the modular approach include flexibility in choosing and upgrading monitors and ease of service; drawbacks include assembling a system that may not be successfully integrated and thus has multiple alarms and/or displays. Anesthesia units and patient monitoring systems should be carefully chosen to ensure that all essential monitoring functions recommended by the American Society of Anesthesiologists are obtained and to ensure optimal integration and an adequate standard of care. For legal reasons, the level-of-monitoring and anesthesiadelivery capabilities for each anesthesia station should be uniform so that all patients receive the same standard of care for the same surgical procedures. Integrated anesthesia workstations, along with the gas/vapor dispensing subsystem and individual physiologic and equipment monitors, may also include a device for automatically dispensing injectable drugs. Consequently, the anesthesia workstation can be viewed as an integrated monitoring system that dispenses anesthetic drugs. Hospitals should also consider the standardization of anesthesia equipment; that is, purchasing systems that are compatible with equipment already in operating rooms or other areas of the hospital (e.g., intensive care units). The purpose of standardization is to allow a reduced parts inventory, minimize the number of suppliers and service personnel, and reduce confusion among the staff. Pulse oximetry is considered a standard of care for monitoring arterial O2 saturation in the operating room during procedures requiring anesthesia and in intensive care units and recovery. Pulse oximeters noninvasively measure O2 saturation of blood hemoglobin (SpO2) and, along with O2 monitors and CO2 monitors, are increasingly being required for anesthesia units by state law. Some U.S. states have specified their own requirements for anesthesia units. Hospitals should check with their state’s department of health for any regulations that may apply to their area. Pulse oximeters provide a spectrophotometric assessment of hemoglobin oxygenation by measuring light transmitted through a capillary bed, synchronized with the pulse. The detection system consists of single-wavelength LEDs (light-emitting diodes) and microprocessors located within a sensor. For more information on pulse oximeters, see the Product Comparison titled Oximeters, Pulse. CO2 monitors measure end-tidal CO2 and can help identify leaks and misconnections as well as indicate when the trachea has not been properly intubated. Many features of anesthesia systems are optional, allowing hospitals to choose those that best fit their needs. Among anesthesia units with essentially equivalent mechanical gas/vapor dispensing subsystems, the monitors included in the system and the ways in which information is integrated and displayed are often the primary distinguishing features.

Cost containment Because anesthesia systems entail ongoing maintenance and operational costs, the initial acquisition cost does not accurately reflect the total cost of ownership. The anesthetic agents are the biggest ongoing expense associated with anesthesia units. Therefore, a purchase decision should be based on issues such as life-cycle cost (LCC), local service support, discount rates, and non-price-related benefits offered by the supplier. An LCC analysis should be conducted to determine the cost-effectiveness of all units that meet users’ needs.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Although costs associated with many of the following may be similar for a number of anesthesia units, they should still be carefully considered to determine the total LCC for budget purposes:    

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Maintenance, service, and inspection Accessories, such as monitoring equipment, necessary to comply with standards Optional accessories Vaporizers (some have been offered at discounted prices or at no cost upon the introduction of a new anesthetic agent)  Gases, including O2, N2O, and anesthetic agents  Anesthesia circuits  Recording and storage of anesthesia-related data  Disposables  Utilities Hospitals can purchase service contracts or service on a time-and-materials basis from the supplier. Service may also be available from a third-party organization. The decision to purchase a service contract should be carefully considered. Most suppliers should provide routine software updates, which enhance the system’s performance, at no charge to service contract customers. Purchasing a service contract also ensures that preventive maintenance will be performed at regular intervals, thereby eliminating the possibility of unexpected maintenance costs. Also, many suppliers do not extend system performance and uptime guarantees beyond the length of the warranty unless the system is covered by a service contract. Hospitals that plan to service their anesthesia units in-house should inquire about the availability and cost of service training and the availability and cost of replacement parts. ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service contracts before the system is purchased. Additional service contract discounts may be negotiable for multipleyear agreements or for service contracts that are bundled with contracts on other similar equipment in the department or hospital. Discounts will depend on the hospital’s negotiating skills and knowledge of discounts offered to other customers, the system configuration and model to be purchased, previous experience with the supplier, and the extent of concessions granted by the supplier, such as extended warranties, fixed prices for annual service contracts, and guaranteed on-site service response. Buyers should make sure that applications training and service manuals are included in the purchase price of the system. Some suppliers offer more extensive on- or off-site training programs for an additional cost. For customized analyses and purchase decision support, readers should contact ECRI Institute’s SELECTplus™ Group.

Stage of development Efforts to improve the design of anesthesia units center on gas supply and proportioning systems, gas monitors, ventilators, vaporizers, and data-handling (display, processing, and reporting) software. There is also an effort to decrease the overall size of anesthesia units. Although anesthesia systems are fundamentally unchanged, manufacturers have made a handful of improvements. Among them are:   

The introduction of low-volume breathing circuits The increasing availability of ventilation modes Increasing automation of pre-use checks

Bibliography Block FE Jr, Schaaf C. Auditory alarms during anesthesia monitoring with an integrated monitoring system. Int J Clin Monit Comput 1996 May;13(2):81-4.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Bromley HR, Tuorinsky S. An uncommon leak in the anesthesia breathing circuit [letter]. Anesth Analg 1997 Sep;85(3):707. Centers for Disease Control and Prevention. Guidelines for prevention of nosocomial pneumonia. Hospital Infection Control Practices Advisory Committee. MMWR Recomm Rep 1997 Jan 3;46(RR-1):1-79.

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Chant K, Kociuba K, Munro R, et al. Investigation of possible patient-to-patient transmission of hepatitis C in a hospital. New South Wales Pub Health Bull 1994 May;5(5):47-51. Davey A, Moyle JT, Ward CS. Ward’s anaesthetic equipment. 4th ed. London: WB Saunders; 1998. Dorsch JA, Dorsch SE. Understanding anesthesia equipment. 4th ed. Baltimore: Lippincott, Williams & Wilkins; 1998. ECRI. Anesthesia systems [evaluation]. 1996 May-Jun;25(5-6):158-211. Anesthesia systems [evaluation]. 2006 Jul; 35(7):242-87. Anesthesia systems [update evaluation]. 1998 Jan;27(1):4-27. Anesthesia systems [update evaluation]. 2002 Apr;31(4):121-49. Anesthesia ventilators with descending bellows: the need for appropriate monitoring [hazard]. 1996 Oct;25(10):391-3. Carbon monoxide exposures during inhalation anesthesia: the interaction between halogenated anesthetic agents and carbon dioxide absorbents [hazard report]. 2000 Nov;27(11):402-4. Anesthesia systems [evaluation]. 2006 Jul;35(7):242-87.

Ehrenwerth J, Eisenkraft JB, eds. Anesthesia equipment: principles and applications. St. Louis: Mosby-Year Book; 1993. Eisenkraft JB, Leibowitz AB. Ventilators in the operating room. Int Anesthesiol Clin 1997 Winter;35(1):87-108. Elliot B, Chestnut J. Dangers of alarms [letter]. Anaesthesia 1996 Aug;51(8):799-800. Failure to test anesthesia machine prior to surgery and to properly monitor patient during surgery. Med Malpract Verdict Settlements 2002 Jun;18(6):4. Heaton J, Hall AP, Fell D. The use of filters in anaesthetic breathing systems [letter]. Anaesthesia 1998 Apr;53(4):407. Hobbhahn J, Hoerauf K, Wiesner G, et al. Waste gas exposure during desflurane and isoflurane anaesthesia. Acta Anaesthesiol Scand 1998 Aug;42(7):864-7. Hogarth I. Anaesthetic machine and breathing system contamination and the efficacy of bacterial/viral filters. Anaesth Intensive Care 1996 Apr;24(2):154-63. Holak EJ, Mei DA, Dunning MB, et al. Carbon monoxide production from sevoflurane breakdown: modeling of exposures under clinical conditions. Anesth Analg 2003 Mar;96(3):757-64. Jack T. A leak of concern [letter]. Br J Anaesth 1998 Jun;80(6):878-9. Komesaroff D. Disposable and autoclavable anaesthetic circuits: the future is now. Anaesth Intensive Care 1996 Apr;24(2):173-5. McMahon DJ. A synopsis of current anesthesia machine design. Biomed Instrum Technol 1991 May-Jun;25(3):190-9. Petty WC. New anesthetic requires new vaporizers for safety. J Clin Monit 1996 Nov;12(6):483. Rogers S, Davies MW. My anaesthetic machine’s on fire *letter+. Anaesthesia 1997 May;52(5):505. Sivalingam P, Hyde RA, Easy WR. An unpredictable and possibly dangerous hazard of an anaesthetic scavenging system [letter]. Anaesthesia 1997 Jun;52(6):609-10.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Snowdon SL. Hygiene standards for breathing systems? [editorial]. Br J Anaesth 1994 Feb;72(2):143-4. Somprakit P, Soontranan P. Low pressure leakage in anaesthetic machines: evaluation by positive and negative pressure tests. Anaesthesia 1996 May;51(5):461-4.

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Supplier information ACOMA Acoma Medical Industry Co Ltd [152410] 2-14-14 Hongo Bunkyo-ku Tokyo 113-0033 Japan Phone: 81 (3) 38166911 Fax: 81 (3) 38143845 Internet: http://www.acoma.com E-mail: [email protected]

AMS AMS (Advanced Medical Systems) Ltd Div GE Healthcare UK [356053] Kazim Karabekir Cad 95/75 Iskitler Ankara TR-06060 Turkey Phone: 90 (312) 3840520 Fax: 90 (312) 3423307 Internet: http://www.ams.com.tr E-mail: [email protected]

ANMEDIC Anmedic AB [397996] Galgbacksvagen 6 Vallentuna S-186 30 Sweden Phone: 46 (8) 51430600 Fax: 46 (8) 51430620 Internet: http://www.anmedic.com E-mail: [email protected] Anmedic UK [398001] PO Box 114 Hayling Island PO11 9QN England Phone: 44 (239) 2463791 Fax: 44 (239) 2350731 Internet: http://www.anmedic.com E-mail: [email protected]

DAMECA Dameca A/S [156977] Islevdalvej 211 Rodovre DK-2610 Denmark Phone: 45 44509990 Fax: 45 44509999 Internet: http://www.dameca.com E-mail: [email protected]

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units DATASCOPE Datascope Corp Patient Monitoring Div [101670] 800 MacArthur Blvd PO Box 619 Mahwah, NJ 07430-0619 Phone: (201) 995-8000, (800) 288-2121 Fax: (201) 995-8606 Internet: http://www.datascope.com

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DATEX-OHMEDA/GE HEALTHCARE GE Healthcare Technologies Clinical Systems (Finland) [452811] Kuortaneenkatu 2 Posti Loaero 300 Helsinki FIN-00031 Finland Phone: 358 (10) 39411 Fax: 358 (10) 3945566 Internet: http://www.gehealthcare.com Datex-Ohmeda Inc Div GE Healthcare [351254] 3030 Ohmeda Dr PO Box 7550 Madison, WI 53707-7550 Phone: (608) 221-1551, (800) 345-2700 Fax: (608) 222-9147 Internet: http://www.gehealthcare.com GE Healthcare Clinical Systems Devices (UK) [452807] 71 Great North Road Hatfield AL9 5EN England Phone: 44 (1707) 263570 Fax: 44 (1707) 260065 Internet: http://www.gehealthcare.com Datex-Ohmeda Pte Ltd (Singapore) Div GE Healthcare [351978] 152 Beach Road #12-05/07 Gateway East Singapore 189721 Republic of Singapore Phone: 65 63918636 Fax: 65 62916618 Internet: http://www.gehealthcare.com E-mail: [email protected]

DRAEGER MEDICAL Draeger Medical UK Ltd [157747] The Willows Mark Road Hemel Hempstead HP2 7BW England Phone: 44 (1442) 213542 Fax: 44 (1442) 240327 Internet: http://www.draeger.com Draeger Medical AG & Co KGaA [374044] Moislinger Allee 53-55 Postfach 1339 Luebeck D-23542 Germany Phone: 49 (451) 8820 Fax: 49 (451) 8822080 Internet: http://www.draeger.com E-mail: [email protected] Draeger Medical Australia Pty Ltd [306071]

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3 Ferntree Place Notting Hill 3168 Australia Phone: 61 (1800) 800327 Fax: 61 (1800) 010327 Internet: http://www.draeger.com.au E-mail: [email protected] Draeger Medical Inc [371341] 3135 Quarry Rd Telford, PA 18969 Phone: (215) 721-5400, (800) 437-2437 Fax: (215) 723-5935 Internet: http://www.draegermedical.com E-mail: [email protected]

EKU ELEKTRONIK EKU Elektronik GmbH [306278] Am Sportplatz Leiningen D-56291 Germany Phone: 49 (6746) 1018 Fax: 49 (6746) 8484 Internet: http://www.eku-elektronik.de E-mail: [email protected]

F STEPHAN F Stephan GmbH Medizintechnik [306280] Kirchstrasse 19 Gackenbach D-56412 Germany Phone: 49 (6439) 91250 Fax: 49 (6439) 912511 Internet: http://www.stephan-gmbh.com E-mail: [email protected] F Stephan Middle East Office [428586] Cabol Street PO Box 17304 Al Rabiya Amman 11195 Jordan Phone: 962 (6) 5548060 Fax: 962 (6) 5548061 Internet: http://www.stephan-gmbh.com E-mail: [email protected] Stephan Polska Sp z o o [428587] ulica Sredzka 42 Swarzedz PL-62-020 Poland Phone: 48 (61) 6511188 Fax: 48 (61) 6516405 Internet: http://www.stephan-gmbh.com E-mail: [email protected]

HEINEN + LOEWENSTEIN Heinen + Loewenstein GmbH [152521] Arzbacher Strasse 80 Bad Ems D-56130 Germany Phone: 49 (2603) 96000 Fax: 49 (2603) 960050

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HEYER MEDICAL Heyer Anesthesia GmbH & Co KG [152523] Carl-Heyer-Strasse 1/3 Postfach 1345 Bad Ems D-56130 Germany Phone: 49 (2603) 7910 Fax: 49 (2603) 70424 Internet: http://www.heyermedical.de E-mail: [email protected]

INTERMED Intermed Equipamento Medico Hospitalar Ltda [174394] Avenida Cupece 1786 Cidade Ademar Sao Paulo-SP 04366-000 Brazil Phone: 55 (11) 56701300 Fax: 55 (11) 55630008 Internet: http://www.intermed.com.br E-mail: [email protected]

KIMURA S Kimura Medical Instrument Co Ltd [152416] 17-5 Yushima 2-chome Bunkyo-ku Tokyo 113 Japan Phone: 81 (3) 38144061 Fax: 81 (3) 38145304 Internet: http://www.kimura-medical.co.jp E-mail: [email protected]

MEDEC Medec Benelux nv [291305] Lion D'orweg 19 Aalst B-9300 Belgium Phone: 32 (53) 703544 Fax: 32 (53) 703533 Internet: http://www.medecbenelux.be E-mail: [email protected]

NORMECA Normeca A/S [162653] Postboks 404 Loerenskog N-1471 Norway Phone: 47 (67) 927600 Fax: 47 (67) 927692 Internet: http://www.normeca.com E-mail: [email protected] Normeca Asia [321497] Kanda-Blanca Building 502 2-18-16 Iwamoto Chiyoda Tokyo 101-0032 Japan Phone: 81 (3) 56873899

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PENLON Penlon Ltd [139281] Abingdon Science Park Barton Lane Abingdon OX14 3PH England Phone: 44 (1235) 547001 Fax: 44 (1235) 547021 Internet: http://www.penlon.com E-mail: [email protected] Penlon America [451484] 11515 K-Tel Dr Minnetonka, MN 55343 Phone: (952) 933-3940, (800) 328-6216 Fax: (952) 933-3375 Internet: http://www.penlonamerica.com E-mail: [email protected]

PNEUPAC Smiths Medical International Ltd [450285] Military Road Hythe CT21 5BN England Phone: 44 (1303) 260551 Fax: 44 (1303) 266761 Internet: http://www.smiths-medical.com E-mail: [email protected]

ROYAL MEDICAL Royal Medical Co Ltd [157039] 4/Fl Mijin Building 464-41 Seokyo-dong Mapo-ku Seoul 121-210 Republic of Korea Phone: 82 (2) 3385561 Fax: 82 (2) 3363328 Internet: http://www.royalmedical.com E-mail: [email protected]

SAMED Samed Elettromedicali srl [187040] strada Provinciale 181 N 1/B Merlino (LO) I-26833 Italy Phone: 39 (02) 90658787 Fax: 39 (02) 90658795 Internet: http://www.samedelettromedicali.com E-mail: [email protected]

SIARE Siare Hospital Supplies srl [152520] via Giulio Pastore 18 Crespellano (BO) I-40056 Italy Phone: 39 (051) 969802 Fax: 39 (051) 969366 Internet: http://www.siare.it E-mail: [email protected]

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units

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SPACELABS HEALTHCARE Blease Medical Equipment Ltd [150950] Beech House Chiltern Court Asheridge Road Chesham HP5 2PX England Phone: 44 (1494) 784422 Fax: 44 (1494) 791497 Internet: http://www.blease.com E-mail: [email protected] Spacelabs Healthcare Inc An OSI Systems Co [101758] 5150 220th Ave SE PO Box 7018 Issaquah, WA 98027-7018 Phone: (425) 657-7200, (800) 522-7025 Fax: (425) 657-7212 Internet: http://www.spacelabshealthcare.com

TAEMA Taema Sub L'Air Liquide SA [151544] 6 rue Georges Besse CE 80 Antony Cedex F-92182 France Phone: 33 (1) 40966600 Fax: 33 (1) 40966700 Internet: http://www.taema.com E-mail: [email protected]

ULCO Ulco Engineering Pty Ltd [157051] 25 Sloane Street Marrickville 2204 Australia Phone: 61 (2) 95195881 Fax: 61 (2) 95502841 Internet: http://www.ulcomedical.com

Note: The data in the charts derive from suppliers’ specifications and have not been verified through independent testing by ECRI Institute or any other agency. Because test methods vary, different products’ specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information. When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost. For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the conversion to U.S. dollars to facilitate comparison among models. Keep in mind that exchange rates change often.

Need to know more? For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail). Last updated May 2008

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Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care.

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The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature, correspondence and discussion with manufacturers and distributors, specifications from product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. 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. The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality, performance, or value, or of claims made for it by the manufacturer. The information and photographs published in Product Comparisons appear at no charge to manufacturers. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights. ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI Institute and its employees accept no royalties, gifts, finder’s fees, or commissions from the medical device industry, nor do they own stock in medical device companies. Employees engage in no private consulting work for the medical device industry.

About ECRI Institute ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology. ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. For more information, visit http://www.ecri.org.

©2008 ECRI Institute. All Rights Reserved

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Product Comparison Chart

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MODEL

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) CONFIGURATION PIPELINE GAS INLETS GAS CYLINDER YOKES VAPORIZERS, AGENTS Type Number Interlock SUCTION SYSTEM O2 FAIL-SAFE HYPOXIC MIXTURE FAILSAFE AUTOMATIC VENTILATOR Bellows, size Type Primary controls Ventilation modes

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Tidal volume Range, cc Minute volume Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio Inspiratory pause Pressure limit, cm H2O PEEP, cm H2O Other controls System checks

ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS Basic-Performance Anesthesia Units1

ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS High-Performance Anesthesia Units1

ACOMA

ACOMA

PH-5FII

PRO-55

Not specified Not specified Not specified Not specified 3 (O2, N2O, air) 2 (O2, N2O) Isoflurane, halothane, enflurane, sevoflurane

Not specified Not specified Not specified Not specified 3 (O2, N2O, air) 2 (O2, N2O) Isoflurane, halothane, enflurane, sevoflurane

All O2 Isoflurane, halothane, enflurane, desflurane, sevoflurane

All O2, N2O, air Isoflurane, halothane, enflurane, desflurane, sevoflurane

1 Yes (if >1 vaporizer) Optional Audible, visual, N2O shutoff Yes (methods vary)

2+ Yes Optional Audible, visual, N2O shutoff Yes (methods vary)

Variable bypass 3 Yes Optional Yes 30% O2

Variable bypass 3 Yes Optional Yes 30% O2

Yes

Yes

Optional

Optional

Adult/pediatric Not specified

Adult/pediatric Ascending

Volume, CMV

CMV, IMV, assist, CPAP

Yes 200-900, 0-2,660 Yes 1-20 5-40, 0-180 5-65, 3-40 1:0.5 to 1:5, 1:0.5 to 1:9.9 Not specified 40, 15-65 0-20 Inspired time control None specified

Yes 100-1,200, 0-2,660 Yes 1.7-20, 1-13 5-40, 0-180 5-62.8, 3-40 1:1 to 1:3, 1:0.5 to 1:9.9 20% or 30% 4-70 0-20 Inspired time control None specified

Manual, spontaneous, VCV

Manual, spontaneous, VCV, PCV, SIMV or pressure support

50-1,200

20-1,500

>20 5-60

>20 5-60

Optional Adjustable, 0.5

DRAEGER MEDICAL Zeus Yes Lead-acid gel >0.5

EKU ELEKTRONIK ARCUS Yes Rechargeable 4

EKU ELEKTRONIK AREA-CT Yes Rechargeable 4

Not specified 1 year Yes 30 days Electrically driven ventilator; fresh-gas decoupled; compliance compensated; compact breathing system; electronic export of freshgas data to an anesthesia information system; warmed breathing system; integrated gas analyzer.

Not specified 2 years Optional 3-4 weeks Portable; built-in flight cases; optional stand-alone ventilator and monitoring (also available in flight cases).

Not specified 2 years Optional 3-4 weeks Electronic gas mixer; small circuit system for low anesthesia; leakage test; electronic supervision of pressure supply with display and alarm function.

10134 May 2008

Not specified 1 year Yes 30 days Electrically driven turbine ventilator with circle flow; fresh-gas decoupled; compliance compensated; compact breathing system; electronic export of all gasdelivering data; closed system; feedback control for FiO2 and anesthetic agent; direct injection of volatile agent; full remote control of IV pumps; 360° pivotable, height-adjustable and tiltable screens; central brake. 10134 May 2008

10134 May 2008

10134 May 2008

1Inspiratory

1Inspiratory

and expiratory values for all measured gases; trends for all; measured gases; curve display for Paw; numeric display for MEAN, PEAK, PLAT, PEEP; curve display for flow (inspiratory/ expiratory); numeric display for MV, Vt, rate, MVleak, Cpat; trends for MV and Cpat; bar graphs for Vt and Paw; low-flow wizard; econometer; optional curve display for SpO2 (plethysmogram); optional numerical display for SpO2 and heart rate; optional trend for SpO2 and pulse; optional p/V-loop and flow/V-loop.

and expiratory values for all measured gases; trends for all; measured gases; curve display for Paw; numeric display for MEAN, PEAK, PLAT, PEEP; curve display for flow (inspiratory/expiratory); numeric display for MV, Vt, rate, MVleak, Cpat; trends for MV and Cpat; bar graphs for Vt and Paw; low-flow wizard; econometer; optional curve display for SpO2 (plethysmogram); optional numeric display for SpO2 and heart rate; optional trend for SpO2 and pulse; optional loops (p/Vloop and flow/V-loop).

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Product Comparison Chart MODEL

EKU ELEKTRONIK AREA-CT4 Worldwide, except North America No Yes Mobile (trolley)

EKU ELEKTRONIK TANGENS 2C Worldwide, except North America No Yes Mobile (trolley, wall, ceiling)

PIPELINE GAS INLETS

3, with electronic gas failure 100% alarm

GAS CYLINDER YOKES VAPORIZERS, AGENTS

Optional Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass

3, plus additional inlet for Xenon with electronic gas failure 100% alarm 2 Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass

1 or 2 Yes Optional Electronic O2 deficiency detection Electronic ratio system, O2 concentration >25% Yes

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WHERE MARKETED FDA CLEARANCE CE MARK (MDD) CONFIGURATION

Type Number Interlock SUCTION SYSTEM O2 FAIL-SAFE HYPOXIC MIXTURE FAILSAFE AUTOMATIC VENTILATOR Bellows, size Type Primary controls Ventilation modes Tidal volume Range, cc Minute volume Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio Inspiratory pause Pressure limit, cm H2O PEEP, cm H2O Other controls

System checks

F STEPHAN AKZENT Worldwide, except USA

F STEPHAN AKZENT X Worldwide, except USA

Not specified Yes Mobile on trolley, wall mounted 5 (2 O2, 2 N2O, air)

Not specified Yes Mobile on trolley, wall mounted 5 (2 O2, 2 N2O, air, Xe)

2 Yes Optional Electronic O2 deficiency detection Electronic ratio system, O2 concentration >25% Yes

2 optional (O2, N2O) Sevoflurane, enflurane, isoflurane, halothane, desflurane Variable bypass, temperature compensated 2 Yes Yes Audible alarm with N2O cutoff Ratio system, minimum 25% O2 Yes

2 optional (O2, N2O) Sevoflurane, enflurane, isoflurane, halothane, desflurane Variable bypass, temperature compensated 2 Yes Yes Audible alarm with N2O cutoff and Xe cutoff Ratio system, minimum 25% O2 Yes

Adult/pediatric Ascending, bag in bottle

Adult/pediatric Ascending, bag in bottle

All Bellows in bottle

All Bellows in bottle

CMV, PCV, manual/spontaneous, SIMV, MMV, ASB Yes 20-1,500 adult; 5-350 neonatal mode Yes 0-99 4-60 adult, 15-150 neonatal mode 10-80 L 2:1 to 1:4 0-50% Ti (PEEP + 5) to 80 hPa 0-20 hPa (integrated) Electronic flow, EVC, pediatric and adult modes, auto dose of fresh-gas flow, special neonatal mode, gas monitoring integrated in ventilator Self-test/control of components, circuit compliance/leakage

CMV, PCV, manual/spontaneous, SIMV, MMV, ASB Yes 20-1,500 adult, 5-350 neonatal mode Yes 0-99 4-60 adult, 15-150 neonatal mode 10-80 2:1 to 1:4 0-50% Ti (PEEP + 5) to 80 hPa 0-20 hPa (integrated) Electronic flow, EVC, pediatric and adult modes, auto dose of fresh-gas flow, special neonatal mode, complete monitoring integrated in 1 screen Self-test/control of components, circuit compliance/leakage

VCV, PCV, SIMV

VCV, PCV, SIMV

Yes1 70-1,500; 5-150, pediatric mode Yes 0.2-45 5-100

Yes1 70-1,500; 5-150, pediatric mode Yes 0.2-45 5-100

140 maximum 1:0.2 to 1:5 in steps of 0.1 No 70 mbar, spontaneous 0-20 Float-type flowmeter

140 maximum 1:0.2 to 1:5 in steps of 0.1 No 70 mbar, spontaneous 0-20 Float-type flowmeter

Electronic self diagnosis including leak test

Electronic self diagnosis including leak test

This is the first of four pages covering the above model(s). These specifications continue onto the next three pages.

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MODEL SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT MONITORS Airway pressure Where measured High-pressure alarm Subatmospheric pressure alarm Continuing pressure alarm Low pressure/apnea Other pressure alarms Expiratory volume/flow Type of sensor Where measured Rate alarm Apnea alarm Reverse-flow alarm High/low minute volume High/low flow Other expiratory alarms O2 concentration Type of sensor Response time, sec CO2 concentration Apnea alarm N2O Agent monitors Type of agents Auto ID Agent concentration alarm

EKU ELEKTRONIK AREA-CT4 AGSS; optional active No No

EKU ELEKTRONIK TANGENS 2C AGSS; optional active Yes Yes

F STEPHAN AKZENT Yes No No

F STEPHAN AKZENT X Yes No No

Peak, plateau Gas inlet 15-78 cm H2O No

Peak, plateau Gas inlet 15-78 cm H2O No

Yes Inspiratory/expiratory limb Yes No

Yes Inspiratory/expiratory limb Yes No

Yes

Yes

Yes

Yes

Yes Peak, PEEP Yes Hot wire Circuit, gas outlet Yes After 12 sec Yes Yes

Yes Peak, PEEP Yes Hot wire Circuit, gas outlet Yes After 12 sec Yes Yes

Yes PEEP, Pmean Yes Pneumotachograph Inspiratory/expiratory limb No Yes No Yes

Yes PEEP, Pmean Yes Pneumotachograph Inspiratory/expiratory limb No Yes No Yes

Yes Disconnection, unit alerts Yes (integrated in ventilator) Galvanic cell (optional paramagnetic) ~12 Yes (integrated in ventilator) Yes Yes (integrated in ventilator) Yes (integrated in ventilator) Isoflurane, halothane, enflurane, desflurane, sevoflurane Optional Yes

Yes Disconnection, unit alerts Yes Galvanic cell (optional paramagnetic) ~12 Yes Yes Yes Yes Isoflurane, halothane, enflurane, desflurane, sevoflurane Optional Yes

Yes No Yes Paramagnetic or electrochemical Not specified Optional Yes Yes Optional Sevoflurane, enflurane, halothane, desflurane, isoflurane Optional Yes

Yes No Yes Electrochemical Not specified Optional Yes Yes Optional Sevoflurane, enflurane, halothane, desflurane, isoflurane No Yes

This is the second of four pages covering the above model(s). These specifications continue onto the next two pages.

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MODEL ECG Heart rate ST segment Noninvasive BP Invasive BP Temperature Pulse oximeter Other monitors Other features DISPLAYS Number Type Integrated Interface with others DATA INPUT PRIORITIZED ALARMS MRI COMPATIBILITY PHYSICAL FEATURES H x W x D, cm (in) Weight, kg (lb) Shelves, cm (in) Drawers, cm (in) Writing shelf, cm (in) POWER REQUIRED, VAC Auxiliary outlets

62

EKU ELEKTRONIK AREA-CT4 Optional Optional Optional Optional No No Optional Volume, pressure, O2, CO2, anaesthetic agents, MAC value Monitoring is integrated in ventilator

EKU ELEKTRONIK TANGENS 2C Yes Yes Yes Yes Yes Yes Yes MAC value, optional EEG

F STEPHAN AKZENT External optional External optional No External optional External optional External optional External optional None specified

F STEPHAN AKZENT X External optional External optional No External optional External optional External optional External optional None specified

Electronic gas mixer, ventilator and monitoring integrated in 1 screen Yes 1 Color TFT-display screen touchscreen (38.1 cm [15"])

Leakage compensation in VCV, compliance compensated Yes 1 EL (15.2 cm [6"])

Leakage compensation in VCV, compliance compensated Yes 1 EL (15.2 cm [6"])

Yes Yes Touchscreen or ComWheel, membrane switches 8 No

Yes RS232 Turn/push button

Yes RS232 Turn/push button

Yes No

Yes No

130 x 48 x 55 (51.2 x 18.9 x 21.7)

160 x 56 x 50 (63 x 22 x 19.7)

65 (143.3) 42 x 43 (16.5 x 16.9) Optional 45 x 46 x 18 (17.7 x 18.1 x 7.1) Optional 41 x 43 (16.1 x 16.9) 115/230 4

75 (165.4) 42 x 43 (16.5 x 16.9) 45 x 46 x 18 (17.7 x 18.1 x 7.1) 41 x 43 (16.1 x 16.9)

77 (140 with trolley) x 74 x 24 (30.3 [55.1 with trolley] x 29.1 x 9.4) 60 (132.3) Optional Optional 20 x 38 x 31 (7.9 x 15 x 12.2) Optional 47 x 37 (18.5 x 14.6) 90-260 4

77 (140 with trolley) x 74 x 24 (30.3 [55.1 with trolley] x 29.1 x 9.4) 60 (132.3) Optional Optional 20 x 38 x 31 (7.9 x 15 x 12.2) Optional 47 x 37 (18.5 x 14.6) 90-260 4

Yes 2 LCD, color TFT-LCD touchscreen (16.3 cm [6.4"]) for ventilator Yes Yes ComWheel, membrane switches 8 No

115/230 4

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MODEL BACKUP BATTERY Type Use per charge, hr PURCHASE INFORMATION Price Warranty Service contract Delivery time, ARO OTHER SPECIFICATIONS

UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes

EKU ELEKTRONIK AREA-CT4 Yes Rechargeable 4

EKU ELEKTRONIK TANGENS 2C Yes Rechargeable 4

F STEPHAN AKZENT Yes Sealed lead-acid 0.5

F STEPHAN AKZENT X Yes Sealed lead-acid 0.5

Not specified 2 years Optional 3-4 weeks Electronic gas mixer; small circuit system for low anesthesia; also leakage test; electronic supervision of pressure supply with display and alarm function; electronic anesthesia record can be attached to this system; other manufacturer's monitors can be used with this system.

Not specified 2 years Optional 3-4 weeks 30.5 cm (12") or 38.1 cm (15") color touchscreen with folding arm can be put in any required position; 1 screen for all operation tasks; neonatal ventilation mode available; alarm system; only 3 levels in user interface (main screen, setting alarms, menu); electronic anesthesia record can be attached to system; interface with other monitors available; TIVA syringe pumps can be connected; TIVA values can be displayed at the central screen; XENON option available (prepared for anesthesia with Xenon including cylinder holding, pressure reducer, tubes, special software); electronic gas mixer for auto dosage, fresh-gas flow, O2 concentration, automatic altitude correction; leakage test, electronic supervision of pressure supply with display and alarm function. 10134 May 2008

Not specified 2 years Offer on request Not specified None specified.

Not specified 2 years Offer on request Not specified Anesthesia with Xenon-gas; fresh gas decouled.

10134 September 2008

10134 September 2008

1Fresh

1Fresh

10134 May 2008

©2008 ECRI Institute. All Rights Reserved

gas compensated.

gas compensated.

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MODEL WHERE MARKETED

F STEPHAN ARTEC : PORTEC Worldwide, except USA

FDA CLEARANCE CE MARK (MDD) CONFIGURATION PIPELINE GAS INLETS

Not specified Yes Mobile, wall mounted 3 (O2, N2O, air)

GAS CYLINDER YOKES

2 optional (O2, N2O) : 2 (O2, N2O) Sevoflurane, enflurane, isoflurane, halothane, desflurane1 Variable bypass, temperature compensated 2:1 Yes Yes : Optional Audible alarm with N2O cutoff Ratio system, minimum 25% O2 Yes

VAPORIZERS, AGENTS Type Number Interlock SUCTION SYSTEM O2 FAIL-SAFE HYPOXIC MIXTURE FAILSAFE AUTOMATIC VENTILATOR Bellows, size Type Primary controls

64

Adult, optional pediatric Bellows in bottle

Ventilation modes

CMV, SCMV, PVC, IMV, SPVC, IPPV, CPAP

Tidal volume Range, cc

Yes 0-1,500; 0-400, pediatric mode Yes 0.5-45 6-60 4-100 1:4 to 2:1 No 70 mbar, spontaneous 0-12 mbar variable Float-type flowmeter

Minute volume Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio Inspiratory pause Pressure limit, cm H2O PEEP, cm H2O Other controls System checks

Electronic system check of ventilator

HEINEN + LOEWENSTEIN Leon Worldwide, except North America No Yes Mobile, wall, ceiling 3 (O2, N2O, AIR) + 2 (O2, N2O) optional 2 (O2, N2O)

HEINEN + LOEWENSTEIN Leon Plus Worldwide, except North America No Yes Mobile, wall, ceiling 3 (O2, N2O, AIR) + 2 (O2, N2O) optional 2 (O2, N2O)

HEINEN + LOEWENSTEIN Sinus Worldwide, except North America No Yes Mobile (standard), wall 3 (O2, N2O, air)

Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass, fully compensated 2 Yes Yes Visual and audible alarm with N2O shutoff Ratio system, 25% O2 in fresh gas Yes

Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass, fully compensated 2 Yes Yes Visual and audible alarm with N2O shutoff Electronic ratio system, 25% O2 in fresh gas Yes

Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass, fully compensated 1 NA Optional Audible alarm with N2O shutoff Ratio system, 25% O2 in fresh gas Yes

Universal Descending, bag in bottle Control knob and touchscreen Manual/spontaneous, IMV, PCV (S-IMV, PSV (assist) optional) Yes 20-1,600

Universal Descending, bag in bottle Control knob and touchscreen Manual/spontaneous, IMV, PCV, S-IMV, S-PCV, PSV (assist) , HLM Yes 20-1,600

Adult/pediatric Ascending, bag in bottle

No 0-25 4-80 120 minimum 4:1 to 1:4 0-90% Ti 10-80 mbar Off, 1-20 Adjustable pressure limitation

No 0-25 4-80 120 minimum 4:1 to 1:4 0-90% Ti 10-80 mbar Off, 1-20 Adjustable pressure limitation

Leak, self-verification tests, tightness, compliance

Leak, self-verification tests, tightness, compliance

No 1-25 6-60 80 maximum 2:1 to 1:4 0-50% Ti 10-80 mbar Off, optional 4-16 Adjustable pressure limitation, EVC (function for fresh-gas compensation) Leak, self-verification tests

No

Manual/spontaneous, IMV, PCV Yes 40-1,600

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SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT MONITORS Airway pressure Where measured High-pressure alarm Subatmospheric pressure alarm Continuing pressure alarm Low pressure/apnea Other pressure alarms Expiratory volume/flow Type of sensor

F STEPHAN ARTEC : PORTEC Yes No No

HEINEN + LOEWENSTEIN Leon Passive AGSS; optional active Log files External optional

HEINEN + LOEWENSTEIN Leon Plus Passive AGSS; optional active Log files External optional

HEINEN + LOEWENSTEIN Sinus Passive AGSS; optional active External optional External optional

Yes Expiratory limb, gas inlet Yes No

Yes Inspiratory patient port 10-85 cm H2O Yes

Yes Inspiratory patient port 10-85 cm H2O Yes

Yes Inspiratory patient port 15-85 cm H2O No

Yes

Yes

Yes

1-60 cm H2O

Yes None

Yes Paw not reached, PEEP not reached Yes Hot wire

Yes Paw not reached, PEEP not reached Yes Hot wire

Yes Not specified

Inspiratory, expiratory flow sensor No Yes No Yes

Inspiratory, expiratory flow sensor No Yes No Yes

No Vte min, inspiratory, expiratory flow sensor disconnect/fail Yes Fuel cell 0.25-0.35 Yes (optional) Yes Yes (optional) Yes (optional) Isoflurane, halothane, enflurane, desflurane, sevoflurane; optional No Yes (optional)

No Vte min, inspiratory, expiratory flow sensor disconnect/fail Yes Paramagnetic or fuel cell 0.25-0.35 Yes Yes Yes Yes Isoflurane, halothane, enflurane, desflurane, sevoflurane; plus mixtures Yes Yes

Yes Heated wire anemometer

Where measured

Expiratory

Rate alarm Apnea alarm Reverse-flow alarm High/low minute volume High/low flow Other expiratory alarms

Yes Yes No Yes

O2 concentration Type of sensor Response time, sec CO2 concentration Apnea alarm N2O Agent monitors Type of agents Auto ID Agent concentration alarm

Yes No Yes Electrochemical ~1 External optional Yes External optional External optional Sevoflurane, enflurane, halothane, desflurane, isoflurane No Yes

Volume Hot wire, optional mechanical Expiratory valve External optional Yes No No Yes No External optional Fuel cell or paramagnetic 12 External optional External optional External optional External optional Isoflurane, halothane, enflurane, desflurane, sevoflurane No External optional

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MODEL ECG Heart rate ST segment Noninvasive BP Invasive BP Temperature Pulse oximeter Other monitors Other features

F STEPHAN ARTEC : PORTEC External optional External optional No External optional External optional External optional External optional Respiratory function (external) None specified

DISPLAYS Number Type

Yes 3 LED

Integrated Interface with others DATA INPUT

Yes No Knobs

PRIORITIZED ALARMS MRI COMPATIBILITY PHYSICAL FEATURES H x W x D, cm (in)

No No

Weight, kg (lb) Shelves, cm (in) Drawers, cm (in) Writing shelf, cm (in) POWER REQUIRED, VAC Auxiliary outlets

66

140 x 60 x 75 (55.1 x 23.6 x 29.5) : 121 x 50 x 55 (47.6 x 19.7 x 21.7) 85 (187.4) : Not specified One 52 x 30 (20.5 x 11.8) : One 48 x 35 (18.9 x 13.8) Three 41 x 50 (16.1 x 19.7) : Three 41 x 40 (16.1 x 15.7) One 45 x 32 (17.7 x 12.6) : No 230 4 : No

HEINEN + LOEWENSTEIN Leon External optional External optional External optional External optional External optional External optional External optional External optional

HEINEN + LOEWENSTEIN Leon Plus External optional External optional External optional External optional External optional External optional External optional External optional

HEINEN + LOEWENSTEIN Sinus External optional External optional External optional External optional External optional External optional External optional None

Calculated values for MAC, user-defined setups (compliance, C20/C, resistance optional) Yes 1 30.7 cm (12.1“) TFT color touchscreen Yes 2 x RS232, 1 x ETH Touchscreen, encoder wheel, touchpanel Yes No

Calculated values for loops, MAC, compliance, C20/C, resistance, user-defined setups Yes 1 38.1 (15“) TFT color touchscreen Yes 2 x RS232, 1 x ETH Touchscreen, encoder wheel, touchpanel Yes No

None

139 x 85 x 69 (54.7 x 33.5 x 27.2)

139 x 85 x 69 (54.7 x 33.5 x 27.2)

145 x 62 x 61 (57.1 x 24.4 x 24)

98 (216) 60 x 30 (23.6 x 11.8)

98 (216) 60 x 30 (23.6 x 11.8)

70 (154.4) 50 x 40 (19.7 x 15.7)

Three 25 x 24 x 8 (9.8 x 9.4 x 3.1) 25 x 32 (9.8 x 12.6)

Three 25 x 24 x 8 (9.8 x 9.4 x 3.1) 25 x 32 (9.8 x 12.6)

13 x 45 x 36 (5.1 x 17.7 x 14.2) 29 x 39 (11.4 x 15.4)

100-240 4

100-240 4

115-230 Optional

Yes 8 LED Yes External optional Push button, wheel, knobs Not specified No

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MODEL BACKUP BATTERY Type Use per charge, hr PURCHASE INFORMATION Price Warranty Service contract Delivery time, ARO OTHER SPECIFICATIONS

UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes

F STEPHAN ARTEC : PORTEC Optional Sealed lead-acid 45 min

HEINEN + LOEWENSTEIN Leon Yes Lead gel 1

HEINEN + LOEWENSTEIN Leon Plus Yes Lead gel 1

HEINEN + LOEWENSTEIN Sinus Yes Lead gel 0.25

Not specified 2 years Offer on request 30 days ARTEC has optional integrated O2 and compressed-air generator with internal suction system, scavenging system, and automatic change to reserve cylinders; both have Ghost certificates.

Not specified 1 year Optional 30 days Alternative gas supply per end-user requirements; lowflow ratio system; alternative integrated monitor configuration per end-user requirements; heated breathing system, material aluminum; fresh-gas decoupled; compliance compensated; external fresh-gas outlet integrated; 3 real-time graphics; MV, Vte, Ppeak, Pmean, Pplateau, and PEEP frequently displayed numerically; inspiratory and expiratory values for all measured gases; trend log for all displayed values; event log, serial output of all displayed values; data output; CO2 bypass antileaks during the canister change; on both sides across the complete height of the device; suction optional working on vacuum; gas type check, no action needed during system test; inspiratory and expiratory values for all measured gases; curve display for Paw, flow, Vte, measured gases; numerical display for Ppeak, Pmean, Pplat, PEEP; MV, Vt, rate.

Not specified 1 year Optional 30 days Alternative gas supply per end-user requirements; air/N2O selection valve; low flow-ratio system.

10134 September 2008

10134 May 2008

Not specified 1 year Optional 30 days Electronic fresh-gas mixer; alternative gas supply per end-user requirements; air/N2O selection valve; low-flow ratio system; alternative integrated monitor configuration per end-user requirements; heated breathing system, material aluminum; freshgas decoupled; compliance compensated; auxiliary 02 flowmeter or external freshgas outlet integrated; 4 realtime graphics; MV, Vte, Ppeak, Pmean, Pplateau, and PEEP frequently displayed numerically; inspiratory and expiratory values for all measured gases; trend log for all displayed values; event log, serial output of all displayed values; data output; CO2 bypass antileaks during the canister change; rail system on both sides across the complete height of the device; suction optional working on vacuum; gas type check, no action needed during system test; inspiratory and expiratory values for all measured gases; curve display for Paw, flow, Vte, measured gases; numerical display for Ppeak, Pmean, Pplat, PEEP; MV, Vt, rate, C; bar graphs for fresh-gas; loops (p/V-loop, flow/V-loop, and p/flow loop). 10134 May 2008

10134 May 2008

1Desflurane

is an optional agent for use with the PORTEC.

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WHERE MARKETED FDA CLEARANCE CE MARK (MDD) CONFIGURATION PIPELINE GAS INLETS GAS CYLINDER YOKES VAPORIZERS, AGENTS Type Number Interlock SUCTION SYSTEM O2 FAIL-SAFE HYPOXIC MIXTURE FAILSAFE AUTOMATIC VENTILATOR Bellows, size Type Primary controls Ventilation modes

68

HEINEN + LOEWENSTEIN Sinus TR Worldwide, except North America No Yes Wall (standard), mobile, pendant 2 (O2, N2O); optional 3 (O2, N2O, air) No Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass, fully compensated 1 NA Optional Audible alarm with N2O shutoff Ratio system, 25% O2 in fresh gas None

HEINEN + LOEWENSTEIN Tizian M Worldwide, except North America No Yes Mobile

HEYER MEDICAL MODULAR Worldwide, except USA

HEYER MEDICAL NARKOMAT + Worldwide, except USA

No Yes Mobile, wall mount

3 (O2, N2O, air)

3 (O2, N2O, air)

No Yes Mobile, ceiling pendant mount 3 (O2, N2O, air)

2 (O2, N2O); 4 optional Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass, fully compensated 2 Yes Optional Audible alarm with N2O shutoff Ratio system, 25% O2 in fresh gas Yes

2 optional (O2, N2O) Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass

2 optional (O2, N2O) Isoflurane, halothane, enflurane, desflurane, sevoflurane Variable bypass

2 Yes Optional Acoustic with N2O shutoff

2 Yes Optional Acoustic with N2O shutoff

Ratio system, >25% O2

Ratio system, >25% O2

Yes

Yes

NA NA

Adult/pediatric Ascending, bag in bottle

1 for all patients Descending, bag in bottle

1 for all patients Descending, bag in bottle

NA

Manual/spontaneous, IMV, PCV Yes 40-1,600 Yes 1-25 6-60 80 maximum 2:1 to 1:4

Manual/spontaneous, CMV, PCV Yes 20-1,400 Yes 0-20 4-60 1-80 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:4, 1:5, 2:1, 3:1 Yes 12-80, adjustable 0-15 Plateau (end inspiratory), 20% or 30% of inspiratory, volume/constant ventilation, O2 flush

Manual, spontaneous, CMV, PCV, S-CMV Yes 20-1,400 Yes 0-20 4-60 1-80 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:4, 1:5, 2:1, 3:1 Yes 12-80, adjustable 0-15 Plateau (end inspiration), 20% or 30% of inspiratory, expiratory pause 30 sec maximum, volume-constant ventilation, O2 flush Automatic at startup

Tidal volume Range, cc Minute volume Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio

NA NA NA NA NA NA NA

Inspiratory pause Pressure limit, cm H2O PEEP, cm H2O Other controls

NA NA NA NA

0-50% Ti 10-80 mbar Off, optional 4-16 Adjustable pressure limitation, EVC

System checks

NA

Leak, self-verification tests

Automatic at startup

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SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT MONITORS Airway pressure Where measured High-pressure alarm Subatmospheric pressure alarm Continuing pressure alarm Low pressure/apnea Other pressure alarms Expiratory volume/flow Type of sensor Where measured Rate alarm Apnea alarm Reverse-flow alarm High/low minute volume High/low flow Other expiratory alarms O2 concentration Type of sensor Response time, sec CO2 concentration Apnea alarm N2O Agent monitors Type of agents Auto ID Agent concentration alarm

HEINEN + LOEWENSTEIN Sinus TR Passive AGSS; optional active External optional External optional

HEINEN + LOEWENSTEIN Tizian M Passive AGSS; optional active External optional External optional

HEYER MEDICAL MODULAR Optional

HEYER MEDICAL NARKOMAT + Optional

External optional External optional

External optional External optional

Yes Inspiratory patient port No No

Yes Inspiratory patient port 15-85 cm H2O No

No

1-60 cm H2O

Yes Inspiratory side Yes Yes (pressure-relief valve included) Yes

Yes Inspiratory side Yes Yes (pressure-relief valve included) Yes

External optional Not specified Volume Mechanical, optional hot wire Expiratory valve External optional External optional No Not specified

Yes Not specified Volume Hot wire, optional mechanical Expiratory valve External optional Yes No Yes

Yes Yes Yes Hot wire

Yes Yes Yes Hot wire

Expiratory valve Yes Yes No Low minute volume

Expiratory valve Yes Yes No Low minute volume

Not specified No External optional Fuel cell or paramagnetic 12 External optional External optional External optional External optional Isoflurane, halothane, enflurane, desflurane, sevoflurane No External optional

Yes No Optional Fuel cell 12 External optional External optional External optional Optional Isoflurane, halothane, enflurane, desflurane, sevoflurane No Optional

No Yes Yes Galvanic cell Not specified External optional Yes External optional External optional Isoflurane, halothane, enflurane, desflurane, sevoflurane No External optional

No Yes Yes Paramagnetic Not specified Yes Yes Yes Yes Isoflurane, halothane, enflurane, desflurane, sevoflurane Yes Yes

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MODEL ECG Heart rate ST segment Noninvasive BP Invasive BP Temperature Pulse oximeter Other monitors Other features DISPLAYS Number Type Integrated Interface with others DATA INPUT PRIORITIZED ALARMS MRI COMPATIBILITY PHYSICAL FEATURES H x W x D, cm (in) Weight, kg (lb) Shelves, cm (in) Drawers, cm (in) Writing shelf, cm (in) POWER REQUIRED, VAC Auxiliary outlets

70

HEINEN + LOEWENSTEIN Sinus TR External optional External optional External optional External optional External optional External optional External optional None None No NA NA NA NA NA No

HEINEN + LOEWENSTEIN Tizian M External optional External optional External optional External optional External optional External optional External optional None None Yes 11 (with options, 17) LED Yes External optional Push button, wheel, knobs Yes No

HEYER MEDICAL MODULAR External optional External optional External optional External optional External optional External optional External optional None specified None Yes 1 EL Yes Not specified Touchscreen 3 (caution, advisory, warning) Not specified

HEYER MEDICAL NARKOMAT + External optional External optional External optional External optional External optional External optional External optional None specified None specified Yes 1 Color TFT Yes Not specified Rotary knob, hotkeys 3 (caution, advisory, warning) Not specified

No 41 x 31 x 27 (16.1 x 12.2 x 10.6) 22 (48.5) Optional Optional No No No

139 x 57 x 61 (54.7 x 22.4 x 24) 110 (242.6) 27 x 61 (10.6 x 24) Three 57 x 60 (22.4 x 23.6) 42 x 57 (16.5 x 22.4) 115-230 Optional

153 x 69 x 74 (60.2 x 27.2 x 29.1) ~95 (209.5) Not specified 2, not specified Yes 120, 60 Hz; 230, 50 Hz O2

154 x 91.5 x 79.5 (60.6 x 36 x 31.3) 170 (374.9) Not specified 2, not specified Yes 120/230, 50/60 Hz Optional

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MODEL BACKUP BATTERY Type Use per charge, hr PURCHASE INFORMATION Price Warranty Service contract Delivery time, ARO OTHER SPECIFICATIONS

UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes

HEINEN + LOEWENSTEIN Sinus TR No NA NA

HEINEN + LOEWENSTEIN Tizian M Yes Lead gel 0.25

HEYER MEDICAL MODULAR Yes Lead gel 0.5

HEYER MEDICAL NARKOMAT + Yes Lead gel 0.5

$5,000-15,500 1 year Optional 30 days Alternative gas supply per end-user requirements; air/N2O selection valve; low flow-ratio system.

$8,000-25,000 1 year Optional 30 days Alternative gas supply per end-user requirements; air/N2O selection valve; low flow-ratio system; alternative integrated monitor configuration per end-user requirements.

Not specified 2 years Not specified 6 weeks Patient circuit: integrated compact bloc-heating device to avoid condensation; low- and minimal-flow ability; automatic compensation for patient system compliance; fresh-gas decoupling; automatic Vt constant.

10134 May 2008

10134 May 2008

Not specified 2 years Not specified 6 weeks Patient circuit: integrated compact bloc-heating device to avoid condensation; 65° pivoting; low- and minimal-flow ability; automatic compensation for patient system compliance; freshgas decoupling; automatic Vt constant. 10134 May 2007

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10134 May 2007

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INTERMED Inter Linea A Worldwide, except European Union No Yes Mobile 3 (O2, N2O, air) 2 (O2, N2O) Isoflurane, halothane, enflurane, sevoflurane

INTERMED Inter Linea C Worldwide, except European Union No Yes Mobile 3 (O2, N2O, air) 1 (O2) Isoflurane, halothane, enflurane, sevoflurane

KIMURA Siesta-21ps Worldwide, except USA

MEDEC Neptune Worldwide

No No Manual 2 (O2, N2O) 2 (O2, N2O) Isoflurane, halothane, enflurane, sevoflurane

Calibrated, variable bypass (temperature, flow, and pressure compensated) 2 Yes No Yes

Calibrated, variable bypass (temperature, flow, and pressure compensated) 1 NA No Yes

Cap screw or key filler

Submitted Yes Mobile on wheels 3 (O2, N2O, air) 2 (O2, N2O) Isoflurane, halothane, enflurane, desflurane, sevoflurane Not specified

Yes

Yes

Minimum 30% O2

2 Yes Yes Electronic and pneumatic alarm system Yes

Yes

Yes

Yes; optional not built-in

Yes

Universal (adult/pediatric/neonate) Ascending

Universal (adult/pediatric/neonate) Ascending

Not specified

1 for neonate to adult

Electrically driven

Horizontal bag in bottle

Manual, VCV-SIMV+PSV, PCV-SIMV+PSV, spontaneous/CPAP+PSV Yes 10-1,500 Yes, indirect NA 1-120 0-120 1:0.3 to 1:99

CMV, assisted CMV

CMV, manual, spontaneous, PCV

Tidal volume Range, cc Minute volume Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio

Manual, VCV-SIMV+PSV, PCV-SIMV+PSV, spontaneous/CPAP+PSV Yes 10-1,500 Yes, indirect NA 1-120 0-120 1:0.3 to 1:99

Yes 100-990 Not specified Not specified 6-40 Not specified 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5

Inspiratory pause Pressure limit, cm H2O PEEP, cm H2O

Yes 5-80, adjustable 0-50 electronic

Yes 5-80, adjustable 0-50 electronic

5% inspiratory time 70, safety relief NA

Pressure support, sigh, manual cycle, inspiratory hold, standby, 100% O2 flush synchronized with expiratory phase, sensitivity (flow trigger): 0.2-2 L/min (neonates), 0.5-5 L/min (pediatrics), and 2-15 L/min (adults) Manual checklist

Pressure support, sigh, manual cycle, inspiratory hold, standby, 100% O2 flush synchronized with expiratory phase, sensitivity (flow trigger): 0.2-2 L/min (neonates), 0.5-5 L/min (pediatrics), and 2-15 L/min (adults) Manual checklist

None specified

Yes 10-1,600 Yes Not specified 4-80 Automatic 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5, 1:6, 2:1, 3:1, 4:1 0-50% 7-99 mbar, adjustable 0-20 cm H2O adjustable, electronic PEEP Auto self-test, full test/maintenance programs

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WHERE MARKETED FDA CLEARANCE CE MARK (MDD) CONFIGURATION PIPELINE GAS INLETS GAS CYLINDER YOKES VAPORIZERS, AGENTS Type Number Interlock SUCTION SYSTEM O2 FAIL-SAFE HYPOXIC MIXTURE FAILSAFE AUTOMATIC VENTILATOR Bellows, size Type Primary controls Ventilation modes

Other controls

System checks

2 No Not specified Yes

Overload, over-range preset, CPU observation

Leaks, resistance, compliance

This is the first of four pages covering the above model(s). These specifications continue onto the next three pages.

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Comprehensive of Biomedical Engineering Site (www.dezmed.com) Anesthesia Units Product Comparison Chart

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MODEL SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT MONITORS Airway pressure Where measured High-pressure alarm Subatmospheric pressure alarm Continuing pressure alarm Low pressure/apnea Other pressure alarms Expiratory volume/flow Type of sensor Where measured Rate alarm Apnea alarm Reverse-flow alarm High/low minute volume High/low flow Other expiratory alarms O2 concentration Type of sensor Response time, sec CO2 concentration Apnea alarm N2O Agent monitors Type of agents Auto ID Agent concentration alarm

INTERMED Inter Linea A Active or passive Up to 24 hr optional Not specified

INTERMED Inter Linea C Active or passive Up to 24 hr optional Not specified

KIMURA Siesta-21ps Optional vacuum or exhaust No Not specified

MEDEC Neptune Vacuum or active Optional Optional

Yes Inspiratory branch Yes Not specified

Yes Inspiratory branch Yes Not specified

Yes Circuit Yes No

Yes Patient circuit 7-99 cm H2O Not specified

Yes

Yes

No

Yes

Yes High PEEP

Yes High PEEP

Yes Not specified

Yes Pneumotachograph Y-piece No Yes No Low minute volume

Yes Pneumotachograph Y-piece No Yes No Low minute volume

No Low pressure, electric failure alarm No NA NA NA NA NA NA

No Not specified Yes Galvanic cell