December This Product Comparison covers the following device term and product code as listed in ECRI s Universal Medical Device

Transcription

1 December 2005 Product Comparison Anesthesia Units UMDN S information This Product Comparison covers the following device term and product code as listed in ECRI s Universal Medical Device Nomenclature System (UMDNS ): Anesthesia Units [10-134] Table of Contents Scope of this Product Comparison...3 Purpose...3 Principles of operation...3 Gas supply and control...4 Vaporizers...4 Ventilation...5 Breathing circuits...6 Scavenging system...7 Monitors and s...7 Automated anesthesia record keepers/anesthesia information management systems...8 Reported problems...9 Purchase considerations...11 ECRI recommendations...11 Other considerations...12 Cost containment...13 Stage of development...14 Bibliography...14 Standards and guidelines...15 Anesthesia breathing circuits...15 Anesthesia equipment...15 Anesthesia unit vaporizers...17 Anesthesia ventilators...17 Anesthetic reservoir bags...18 Medical gas piping...18 Scavenging systems...18 Citations from other ECRI publications...19 Supplier information...21 About the chart specifications

2 Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI, a nonprofit health services research agency established in HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. 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 s Problem Reporting System. While these data are reviewed by qualified health professionals, they have not been tested by ECRI s clinical and engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and ECRI 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 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 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 ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research agency. Its mission is to improve the safety, quality, and cost-effectiveness of healthcare. It is widely recognized as one of the world s leading independent organizations committed to advancing the quality of healthcare. ECRI s focus is healthcare technology, healthcare risk and quality management, and healthcare environmental management. It provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, voluntary sector organizations, associations, and accrediting agencies worldwide. Its more than 30 databases, publications, information services, and technical assistance services set the standard for the healthcare community. ECRI s services alert readers to technology-related hazards; disseminate the results of medical product evaluations and technology assessments; provide expert advice on technology acquisitions, staffing, and management; report on hazardous materials management policy and practices; and supply authoritative information on risk control in healthcare facilities and clinical practice guidelines and standards. 2

3 December 2005 Anesthesia Units Scope of this Product Comparison This Product Comparison covers anesthesia systems that can have the following components: mainframes, hanger yokes and gauges, flowmeters, vaporizers, flush valves, carbon dioxide (CO2) absorbers, ventilators, scavenging systems, monitors, and s. Not included 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 not included are separate stand-alone physiologic monitoring systems. For information on these devices, see the following Product Comparisons: Halogenated Anesthetics Analyzers Multiple Medical Gas Monitors, Respired/Anesthetic Oxygen Monitors Physiologic Monitoring Systems, Acute Care; Neonatal; ECG Monitors Pressure Monitors, Airway 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. Basically, anesthesia units 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, anesthesiarelated risks to the patient and clinical staff The patient is anesthetized by inspiring a mixture of O2, the vapor of a volatile liquid halogenated hydrocarbon anesthetic, and, if necessary, N2O 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 four basic subsystems: a gas supply and control circuit, a breathing and ventilation circuit, a scavenging system, and a set of system function and breathing circuit monitors (e.g., inspired O2 concentration, airway pressure). Also included in some anesthesia systems are a number of monitors and s that indicate levels and variations of several 3

4 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, s, 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. Gas supply and control Because O2 and N2O are used in large quantities, they are usually drawn from the hospital s central gas supplies. In some countries, 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 generally include indexing systems (e.g., specific patern 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 one-way 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. Most anesthesia machines have an O2-supply-failure device and an 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. 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 N2O 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 from the Y-piece of the patient s breathing circuit and displays O2 concentration in volume percent. O2 monitors should sound an 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 O2 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. In some units, the anesthetic gas flow momentarily shuts off. Vaporizers Because the inhaled anesthetic agents, with the exception of N2O, exist as liquids at room temperature and sea-level ambient pressure, they must be evaporated by a vaporizer. Vaporizers add a controlled amount of anesthetic vapor to the gas mixture. Some anesthesia units can accommodate up to three vaporizers. Most units have a lockout mechanism that prevents the use of more than one vaporizer at a time. There are several types of vaporizers, including variable bypass 4

5 Reserve Cylinders Gas Supply Gas/Vapor Blending System Gas Control and Flowmeters Vaporizer O Flush Valve 2 Fresh Gas Flow Breathing Circuit Selector Valve Patient APL Valve N O Shutoff/Low O Pressure Alarm 2 2 Gas Pipelines To Atmosphere Ventilator Scavenging System Reservoir Bag C866UN7A-01 Figure 1. Continuous-flow anesthesia system (conventional), heated blender, measured flow, and draw-over. Variable bypass vaporizers can be either mechanically or electronically controlled. 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. In this type of vaporizer, 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 not concentration calibrated; in this type of vaporizer, a measured flow of carrier gas is used to pick up anesthetic gas. This type of vaporizer has become almost obsolete in the United States since the adoption of an ASTM International standard that requires all vaporizers to be concentration calibrated; it may still be in use outside the United States. Draw-over vaporizers are sometimes used by the military in the field, but they are not typically used in the United States. They are usually employed in situations or countries in which pressurized gas sources are unavailable. Such units offer low resistance to gas flow and are relatively simple. 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. 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 5

6 forces the anesthesia gas mixture into the patient s breathing circuit and lungs and, in a circle breathing system (discussed below), 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. 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 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. Fresh Gas Flow C866UN7A-02 One-Way Valve CO Absorber 2 One-Way Valve To Mechanical Ventilation and the Scavenging System Fresh Gas Flow To Mechanical Ventilation and the Scavenging System Circle Breathing System Idealization of T-Piece System Figure 2. Examples of breathing circuits Breathing circuits Most anesthesia systems are continuous-flow systems (see Fig. 1), which 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 Fig. 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. 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 CO2 depends on fresh-gas flow and occurs in direct proportion to that flow. 6

7 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 include a lower circuit compliance, easier circuit sterilization, and a less complex design requiring fewer valves and no CO2 absorber (although one can be used with it). Because excess pressure imposed on the patient s lungs can cause serious lung damage, either an APL valve or a valve in the ventilator 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 H2O; 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 s 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 s), 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. Some units may have methods of integrating, analyzing, displaying, and recording the information generated by the monitors sensors and s. Microprocessors have been incorporated into the systems to implement these functions. Stand-alone microprocessor-controlled data collection and display units have been used to integrate modular anesthesia systems. These units can also be 7

8 used as part of an anesthesia information management system (AIMS). Integration of the information and s from each of the monitors into a single display 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 s can sometimes cause confusion among anesthetists and operating room teams by sounding numerous s simultaneously. In an integrated system of information and s, visual messages appear on a central display; furthermore, audible and visual s are prioritized so that the more urgent sounds and visual signals are associated with the more vital monitored variables. 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 s, plus explanatory messages. 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] or 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 stated it may be useful for at-risk patients to be monitored for intraoperative awareness. For additional information, visit ASA s Website at 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 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 8

9 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 can be critical. Pre-use checklists, regular inspections, and preventive maintenance are critical to minimizing anesthesia unit hazards. One of the greatest dangers of general anesthesia is a lack of O2 delivered to the patient (hypoxia), which can result in brain damage or death. Conversely, the administration of O2 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% O2 is particularly acute in neonatal anesthesia, during which retrolental fibroplasia and bronchopulmonary dysplasia can be caused by inhalation of 100% O2 even for a very short duration. Inadequate O2 delivery can be caused by any number of conditions, including disconnection of the patient from the breathing circuit; accidental movement of the O2, 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 (in an anesthesia unit with an ascending bellows or piston) in the anesthesia system. An O2 monitor warns of inadequate O2 concentration in the inspiratory limb. A CO2 monitor or a spirometer (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 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 CO2 absorbents can produce CO if the CO2 absorbent is excessively dry. Drying out 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 CO2 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 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, please 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 cross-contamination. There has been some controversy 9

10 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. Also, 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 and some filters can be sterilized and reused. The piping connections for O2 and N2O within the hospital walls can be accidentally interchanged during installation or repair of medical gas systems, potentially for 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. In the United States, 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. Countries outside the United States have similar requirements to ensure the proper connection of all medical gas hoses to the anesthesia machine. ECRI has seen instances of improper connections in which damaged pins allowed users to force the wrong cylinder into place. ECRI 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. The increased interest in low-flow anesthesia to reduce costs has increased the potential danger associated with leaks in the anesthesia unit. Because low-flow anesthesia requires very little fresh gas flow, a leak in the equipment can result in inadequate delivery of O2 and anesthetic gases. Regular testing of the anesthesia equipment using standard leak tests should minimize the risk of leaks during the administration of anesthesia. 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 s can cause confusion by sounding numerous s simultaneously. While integrated monitors and s are becoming more widespread, both modular and integrated systems are subject to the confusion caused by false s. A false, caused by accidental patient movement or other nonphysiological reasons, can confuse operating room staff and possibly draw attention away from other s that may truly indicate a change in the patient s physiologic condition. Ensuring that the limits are properly set and positioning sensors and electrodes in such a way as to minimize artifacts can reduce the incidence of false s. Also, ECRI recommends that users do not set physiologic limits below normal values in order to reduce nuisance s. 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. Also, anesthesia machines are designed to be 10

11 compatible with MRI units when used in accordance with the instructions and precautions contained in the operation manual and on the unit itself. If the instructions are not followed, the anesthesia units could be attracted to MRI units, potentially causing user or patient injury. Many MRIcompatible 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 can become airborne and crash into the magnet. Also, 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 or the MRI unit itself). A few suppliers offer MRI-compatible anesthesia machines, and a line of MRI-compatible monitors is available. Users should be careful not to hang any extraneous materials (e.g., polyethylene garbage bags) or equipment from anesthesia units. If accidentally bumped, the hanging objects may compromise the anesthesia unit s stability and be sucked into the receiving end of the anesthesia unit. This could cause the full negative pressure to be transmitted to the patient breathing system, collapsing the reservoir bag. Purchase considerations ECRI recommendations Included in the accompanying comparison chart are ECRI s recommendations for minimum performance requirements for anesthesia units. The recommendations are listed in two categories: basic and high performance. ECRI 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 in case central supplies fail, and an internal battery (for units with automatic ventilators) capable of powering the unit for at least 30 minutes. An anesthesia unit should consist of a gas supply and control circuit, a breathing and ventilation circuit, and a scavenging system (not required on basic systems). 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 O2 supply, an undefeatable audible 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 for longer than two minutes. Line-powered units should have a power-loss and battery-powered units should have an automatic low-battery. All line-powered 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. The battery 11

12 should also operate the anesthesia unit and integral monitors for at least 30 minutes. A low-battery should visually and audibly indicate when the battery voltage falls to a level below which the unit may fail to perform satisfactorily. If the battery is rechargeable, it should not require more than 16 hours to recharge 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. High-perfomance 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., O2 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 illsuited 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. 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 s. Modular systems can be less expensive than preconfigured systems, especially if the facility already owns the monitors. 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 s and/or multiple displays. Anesthesia units and patient monitoring systems should be carefully chosen to ensure that all the 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 anesthesia-delivery 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. 12

13 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 the ones 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-pricerelated benefits offered by the supplier. An LCC analysis should be conducted to determine the cost-effectiveness of all the units that meet the users needs. 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: 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 When selecting a vaporizer, consider the type of anesthetic agent required for the hospital s patient mix in conjunction with the types of procedures being performed. Users should ask the supplier if the anesthetic gas monitor will be able to identify and measure all anesthetic agents used (i.e., some models may not recognize sevoflurane). 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 inhouse should inquire about the availability and cost of service training and the availability and cost of replacement parts. ECRI 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 multiple-year 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 onsite 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 s SELECT Group. 13

14 Stage of development Efforts to improve the design of anesthesia units center on gas supply and proportioning systems, breathing circuits, gas scavenging and humidification devices, 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 s during anesthesia monitoring with an integrated monitoring system. Int J Clin Monit Comput 1996 May;13(2):81-4. 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. 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): Davey A, Moyle JT, Ward CS. Ward s anaesthetic equipment. 4th ed. London: WB Saunders; Dorsch JA, Dorsch SE. Understanding anesthesia equipment. 4th ed. Baltimore: Lippincott, Williams & Wilkins; Ehrenwerth J, Eisenkraft JB, eds. Anesthesia equipment: principles and applications. St. Louis: Mosby-Year Book; Eisenkraft JB, Leibowitz AB. Ventilators in the operating room. Int Anesthesiol Clin 1997 Winter;35(1): Elliot B, Chestnut J. Dangers of s [letter]. Anaesthesia 1996 Aug;51(8): 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 and isoflurane anaesthesia. Acta Anaesthesiol Scand 1998 Aug;42(7): Hogarth I. Anaesthetic machine and breathing system contamination and the efficacy of bacterial/viral filters. Anaesth Intensive Care 1996 Apr;24(2): 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): Jack T. A leak of concern [letter]. Br J Anaesth 1998 Jun;80(6): Komesaroff D. Disposable and autoclavable anaesthetic circuits: the future is now. Anaesth Intensive Care 1996 Apr;24(2): McMahon DJ. A synopsis of current anesthesia machine design. Biomed Instrum Technol 1991 May- Jun;25(3):

15 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): Snowdon SL. Hygiene standards for breathing systems? [editorial]. Br J Anaesth 1994 Feb;72(2): Somprakit P, Soontranan P. Low pressure leakage in anaesthetic machines: evaluation by positive and negative pressure tests. Anaesthesia 1996 May;51(5): Standards and guidelines Note: Although every effort is made to ensure that the following list is comprehensive, please note that other applicable standards may exist. Also, there are many state rules and regulations in the United States regarding anesthesia machines; consult ECRI s Healthcare Standards Directory or your state department of health for more information. Anesthesia breathing circuits ASTM International. Specification for particular requirements for anesthesia workstations and their components [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (revised 2000). Specification for anesthetic breathing tubes [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1999) (reapproved 1999). Specification for minimum performance and safety requirements for components and systems of anesthetic gas monitors [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1992) Australian and New Zealand College of Anaesthetists. Protocol for checking the anaesthetic machine. PS (revised 1997). European Committee for Standardization/Danish Standards Association. Breathing tubes intended for use with anaesthetic apparatus and ventilators [standard]. DS/EN 12342: Hong Kong College of Anaesthesiologists. Protocol for checking an anesthetic machine before use [policy statement] International Organization for Standardization. Breathing tubes intended for use with anaesthetic apparatus and ventilators [standard]. 4th ed. ISO 5367: Inhalational anaesthesia systems part 2: anaesthetic circle breathing systems [standard]. 2nd ed. ISO : (revised 1999). Anesthesia equipment American Association of Nurse Anesthetists. Infection control guide [guideline] (revised 1997). American National Standards Institute. Minimum performance and safety requirements for components and systems of continuous-flow anesthesia machines for human use [standard]. ANSI Z American Society of Anesthesiologists. Recommendations for infection control for the practice of anesthesiology. 2nd ed

16 Standards for basic anesthetic monitoring (reaffirmed 15 Oct 2003). Association of Perioperative Registered Nurses. Recommended practices for cleaning and processing anesthesia equipment [recommended practice] (revised 2004). ASTM International. Specification for particular requirements for anesthesia workstations and their components [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (revised 2000). Specification for signals in medical equipment used in anesthesia and respiratory care [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1999) (revised 1999). Specification for anesthetic equipment oropharyngeal and nasopharyngeal airways [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (2000) (revised 2000). Australian and New Zealand College of Anaesthetists. Recommendations on checking anaesthesia delivery systems (revised 2003). British Standards Institution. Anaesthetic and analgesic machines. Specification for continuous flow anaesthetic machines [standard]. BS : Anaesthetic and analgesic machines. Specification for intermittent (demand) flow analgesic machines for use with 50/50% (V/V) nitrous oxide and oxygen [standard]. BS : (revised 1996). Canadian Anesthesiologists Society. Guidelines to the practice of anaesthesia (revised 2003). Canadian Standards Association. Anaesthetic machines for medical use [standard]. CSA Z (R2001) (reaffirmed 2001). Danish Standards Association/European Committee for Standardization. Anaesthetic workstations and their modules particular requirements [standard]. DS/EN740: European Committee for Standardization. Anaesthetic and respiratory equipment conical connectors part 1: cones and sockets [standard]. EN : (revised 1997). International Electrotechnical Commission. Medical electrical equipment part 1: general requirements for safety [standard]. IEC ( ) Medical electrical equipment part 1: general requirements for safety. Amendment 1 [standard]. IEC am1 ( ) Medical electrical equipment part 1: general requirements for safety. Amendment 2 [standard]. IEC am2 ( ) Medical electrical equipment part 1-1: general requirements for safety. Collateral standard: safety requirements for medical electrical systems. 2nd ed. IEC ( ) (revised 2000). Medical electrical equipment part 1-2: general requirements for safety. Collateral standard: electromagnetic compatibility requirements and tests. IEC ( ) (revised 2001). Medical electrical equipment part 1-4: general requirements for safety. Collateral standard: programmable electrical medical systems. IEC ( ) (revised 2000). 16

17 Medical electrical equipment part 2-13: particular requirements for the safety of anesthetic workstations [standard]. IEC ( ) International Organization for Standardization. Anaesthesia and respiratory care signals part 1: visual signals [standard]. 1st ed. ISO 9703:Part 1: Anaesthesia and respiratory care signals part 2: auditory signals [standard]. 1st ed. ISO : Anaesthesia and respiratory care signals part 3: guidance on application of s [standard]. 1st ed. ISO : Anaesthetic and respiratory equipment conical connectors part 1: cones and sockets [standard]. 2nd ed. ISO 5356: (revised 1996). Anaesthetic and respiratory equipment conical connectors part 2: screw-threaded weightbearing connectors [standard]. 1st ed. ISO : Anaesthetic and respiratory equipment heat and moisture exchangers (HMEs) for humidifying respired gases in humans part 1: HMEs for use with minimum tidal volumes of 250 ml [standards]. 1st ed. ISO : Anaesthetic and respiratory equipment heat and moisture exchangers (HMEs) for humidifying respired gases in humans part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml [standard]. 1st ed. ISO : Anaesthetic gas monitors [standard]. 1st ed. ISO 11196: Inhalational anaesthesia systems part 4: anaesthetic vapor delivery devices [standard]. ISO : Jun. Standards Australia/Standards New Zealand. Anaesthetic machines non-electrical for use with humans [standard]. AS/NZS Underwriters Laboratories, Inc. Electrically conductive equipment and materials for use in flammable anesthetizing locations [standard]. 3rd ed (revised 1997). U.S. Department of Health and Human Services. Food and Drug Administration. Anesthesiology devices. 21 CFR Part U.S. Department of Labor. Occupational Safety and Health Administration. Anesthetic gases: guidelines for workplace exposures Jul 20 (revised 2000 May 18). Anesthesia unit vaporizers European Committee for Standardization. Agent specific filling systems for anaesthetic vaporizers part 1: rectangular keyed filling systems [standard]. EN : Internation Organization for Standardization. Anaesthetic vaporizers agent-specific filling systems [standard]. 1st ed. ISO 5360: Anesthesia ventilators ASTM International. Specification for minimum performance and safety requirements for anesthesia breathing systems [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1994) (reapproved 1994). 17

18 Specification for particular requirements for anesthesia workstations and their components [standard]. ASTM Committee F29 Anesthetic and Respiratory Equipment. F (revised 2000). Specification for ventilators intended for use during anesthesia [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1996) (revised 1996). Canadian Standards Association. Anaesthesia ventilators [standard]. CAN/CSA-Z (R2001) (reaffirmed 2001). Center for Devices and Radiological Health. Anesthesia apparatus checkout recommendations International Organization for Standardization. Breathing tubes intended for use with anaesthetic apparatus and ventilators [standard]. 4th ed. ISO 5367: Anesthetic reservoir bags American Society for Testing and Materials. Specification for anesthesia reservoir bags [standard]. ASTM Committee F29 on Anesthetic and Respiratory Equipment. F (1998) (reapproved 1998). Medical gas piping Canadian Standards Association. Low-pressure connecting assemblies for medical gas systems [standard]. CAN/CSA-Z305.2-M88(R2001) (reaffirmed 2001). Medical oxygen concentrator central supply system: for use with nonflammable medical gas piping systems [standard]. CAN/CSA-Z (R2001) (reaffirmed 2001). Danish Standards Association/European Committee for Standardization. Medical gas pipeline systems part 2: anaesthetic gas scavenging disposal systems basic requirements [standards]. DS/EN 737-2: European Committee for Standardization. Medical gas pipeline systems part 4: terminal units for anaesthetic gas scavenging systems [draft standard]. EN 737-4: International Organization for Standardization. Terminal units for medical gas pipeline systems part 2: terminal units for anaesthetic gas scavenging systems. 1st ed. ISO : National Fire Protection Association/American National Standards Institute. Fire protection in health care facilities [standard]. ANSI/NFPA In the United States, medical-gas pipeline systems must be constructed and maintained to meet the requirements of NFPA 99. Chapter 4 of this code specifically covers medical-gas and vacuum systems. A number of other countries, including Britain, France, and Japan, have requirements based on this code. Scavenging systems American National Standards Institute. Scavenging systems for excess anesthetic gases [standard]. ANSI Z European Committee for Standardization. Medical gas pipeline systems part 4: terminal units for anaesthetic gas scavenging systems [draft standard]. pren 737-4: International Organization for Standardization. Inhalational anaesthesia systems part 3: anaesthetic gas scavenging systems transfer and receiving systems [standard]. 1st ed. ISO : Medical gas pipeline systems part 2: anaesthetic gas scavenging disposal systems. 1st ed. ISO 18

19 7396-2: National Institute for Occupational Safety and Health. Development and evaluation of methods for elimination of waste anesthetic gases and vapors in hospitals. NTIS No. PB Waste anesthetic gases and vapors [recommendation]. NTIS No. PB Citations from other ECRI publications Health Devices Concentration calibrated vaporizers [hazard] Mar-Apr;16(3-4):112. Pre-use testing prevents helpful reconnection of anesthesia components [hazard] May;16(5): Who should service anesthesia equipment? [User Experience Network ] Feb;17(2):70-1. Barotrauma from anesthesia ventilators [hazard] Nov;17(11):354. Oxygen regulator fire caused by use of two yoke washers [hazard] Nov;19(11): Risk of barotrauma and/or lack of ventilation with ventilatorless anesthesia machines [hazard] Jan-Feb;23(1-2):54-5. False CO2 readings from disposable anesthesia breathing circuits with an internal gas-sampling line [hazard] Apr;24(4): Fires from oxygen use during head and neck surgery [hazard] Apr;24(4): Anesthesia systems [evaluation] May-Jun;25(5-6): Anesthesia ventilators with descending bellows: the need for appropriate monitoring [hazard] Oct;25(10): Leaching of the plasticizer from PVC tubing in heart-lung bypass unit tubing circuits [User Experience Network ] Oct;25(10): Anesthesia systems [update evaluation] Jan;27(1):4-27. Surgical fires: learning prevention [Talk to the specialist] Sep;28(9): Carbon monoxide exposures during inhalation anesthesia: the interaction between halogenated anesthetic agents and carbon dioxide absorbents [hazard report] Nov;27(11): Anesthesia systems [update evaluation] Apr;31(4): Anesthesia carbon dioxide absorber fires [hazard report online preview] Nov [cited 2003 Nov 19]. Available from Internet: Nov- AnesthesiaCO2Fires.pdf. Ventilator failures on Draeger Medical Fabius GS and Fabius Tiro anesthesia units [problem report] 2005 Jul;(34(7):23-5. Health Devices Alerts This Product Comparison lists Health Devices Alerts (HDA) citations published since the last update of this report. Each HDA abstract is identified by an Accession Number. Recalls and hazard reports include descriptions of the problem involved; abstracts of other published articles are referenced by bibliographic information. HPCS subscribers can call the Hotline for additional information on any of these citations or to request more extensive searches of the HDA database. 19

20 A5794 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Medical Device Alert notifying healthcare workers that the Association of Anaesthetists of Great Britain and Ireland (AAGBI) has published an updated version of its guideline "Checking Anaesthetic Equipment." The document was developed to prevent inadequate pre-use checks of anesthetic equipment. Use of inadequately checked anesthetic equipment has been associated with serious patient consequences, such as hypoxic brain damage or death. AAGBI and MHRA recommend that all U.K. anesthesia practitioners follow the updated AAGBI checklist, which is available online at Laminated copies of the 2-page checklist are available from AAGBI and should be attached to every anesthesia unit. Inquiries to AAGBI should be addressed to the Association of Anaesthetists of Great Britain and Ireland by mail at 21 Portland Place, London W1B 1PY, England; by telephone at (0207) ; by fax at (0207) ; or by at [email protected]. Technical inquiries to MHRA should be addressed to Douglas McIvor or Nigel Richards, MHRA, by mail at Hannibal House, Elephant and Castle, London SE1 6TQ, England; by telephone at (0207) or 8277, respectively; by fax at (0207) ; or by at [email protected] or [email protected], respectively. Clinical inquiries to MHRA should be addressed to Dr. Susanne Ludgate, MHRA, by mail at the above address, by telephone at (0207) , by fax at (0207) , or by at [email protected]. All inquiries to MHRA should quote reference no Source: Great Britain. Medicines and Healthcare Products Regulatory Agency. Anaesthetic equipment and associated devices. London: Department of Health; 2004 Jan p. (Medical device alert; no. MDA/2004/003). A6015 FDA has designated this Class II Recall No. Z for certain Draeger Medical anesthesia units. In some cases, the rotary-knob-style APL valve of these anesthesia machines may separate from the unit. The APL valve is located on the breathing system, and the rotating knob is used to adjust airway pressure during manual ventilation. If the APL valve separates during use, manual ventilation will not be possible. Spontaneous and automatic ventilation will not be affected by APL valve separation. The manufacturer states that the failure rate is approximately 1% and that there have been no reported injuries resulting from this malfunction. The manufacturer initiated a recall by letter dated September 15, Verify that you have received the September 15, 2004, letter from Draeger. Identify any affected product in your inventory by removing the APL valve from the breathing system so that you can view the retaining nut, which will have the part number, revision level, and serial number stamped on the bottom. A DraegerService representative or authorized service organization will contact you to schedule replacement of affected APL valves. As standard practice and as referenced in the pre-use check in the operator s instruction manual, you should always have emergency ventilation equipment, such as a manual resuscitator, available for use with any anesthesia machine. For further information, contact Mike Kelhart, Draeger regulatory affairs, by telephone at (800) , ext. 2349, within the U.S. or at (215) outside the U.S. For further information regarding replacement of your APL valve, contact Draeger Service technical support by at [email protected] or by telephone at (800) (press #3 at the prompt) within the U.S. Source: FDA Enforcement Rep 2004 Nov 24; letter submitted by manufacturer. A6296 FDA has designated this action Class II Recall No. Z for certain Maquet anesthesia systems. A software update (version 7.0) has been released for these anesthesia systems. The manufacturer notified U.S. customers by letter dated January 11, The firm states that all systems have been updated or returned. No further action is required of customers. Source: FDA Enforcement Rep 2005 Apr 20; Manufacturer. D6528 FDA has designated this Class II Recall No. Z complete for certain Datascope anesthesia delivery units. The alternating current (AC) mains switch may fail, resulting in a loss of AC power. If AC power loss were to occur during device operation, the system would shift to battery operation to maintain pneumatic ventilation, sound an audible, and display intermittent 20

21 messages every 5 minutes to advise of the remaining battery time. The manufacturer initiated a field correction by a service representative visit in June The firm states that the field correction is complete. No further action is required of customers. Source: FDA Enforcement Rep 2004 Sep 22; Manufacturer Aldridge J. Leak on Datex Aestiva/5 anaesthetic machine [letter]. Anaesthesia 2005 Apr;60(4): Health Devices Inspection and Preventive Maintenance System Anesthesia unit vaporizers. Procedure no Anesthesia unit ventilators. Procedure no Anesthesia units. Procedure no Capnometers and multiple medical gas monitors. Procedure no Healthcare Risk Control Surgery and anesthesia. 1996;4:Surgery and anesthesia 3:1-14. NIOSH alert: controlling exposures to nitrous oxide during anesthetic administration. 1996;4:Surgery and anesthesia Overview of anesthesia liability. 1996;4:Surgery and anesthesia 2:1-6. Waste anesthetic gas. 1996;4:Surgery and anesthesia 15:1-10. Pre-use checklist for anesthesia units (machines and accessories). 1996;4:Surgery and anesthesia 12:1-2. Operating Room Risk Management Automated anesthesia record keeping Jul;1:Anesthesia:8. Patient monitoring in the OR: vigilance, monitoring, and the standard of care Jul;1:Anesthesia 1:1-11. Pre-use checklist for anesthesia units (machines and accessories) Jul;1:Anesthesia 3:1-3. Selecting and using multiple medical gas monitors Jul;1:Anesthesia 5:1-4. Selecting and using physiologic monitors Jul;1:Anesthesia 4:1-11. Anesthesia malpractice: an overview Jul;1:Anesthesia 2:1-7. Desflurane (Suprane) Oct;1:Anesthesia 11:1-9. NIOSH alert: controlling exposures to nitrous oxide during anesthetic administration Oct;1:Anesthesia 9:1-15. Supplier information Acoma Acoma Medical Industry Co Ltd [152410] Hongo Bunkyo-ku Tokyo Japan Phone: 81 (3) Fax: 81 (3) Internet: [email protected] 21

22 AMS AMS (Advanced Medical Systems) Ltd [356053] Kazim Karabekir Cad 95/ Iskitler TR Ankara Turkey Phone: 90 (312) Fax: 90 (312) Internet: Anmedic Anmedic AB [397996] Galgbacksvagen 6 S Vallentuna Sweden Phone: 46 (8) Fax: 46 (8) Internet: [email protected] Anmedic UK [398001] PO Box 114 Hayling Island Hampshire PO11 9QN England Phone: 44 (239) Fax: 44 (239) Internet: [email protected] Blease Blease Medical Equipment Ltd [150950] Beech House Chiltern Court Asheridge Road Chesham Buckinghamshire HP5 2PX England Phone: 44 (1494) Fax: 44 (1494) Internet: [email protected] Dameca Dameca A/S [156977] Islevdalvej 211 DK-2610 Rodovre Denmark Phone: Fax: Internet: [email protected] Datascope Datascope Corp, Patient Monitoring Div [101670] 800 MacArthur Blvd PO Box 619 Mahwah, NJ Phone: (201) (800) Fax: (201) Internet: [email protected] Datex-Ohmeda/GE Healthcare Datex-Ohmeda (Finland) [351977] Kuortaneenkatu 2 Posti Loaero 300 FIN Helsinki Finland Phone: 358 (10) Fax: 358 (10)

23 Internet: Datex-Ohmeda Inc, Div GE Healthcare [351254] 3030 Ohmeda Dr PO Box 7550 Madison, WI Phone: (608) (800) Fax: (608) Internet: Datex-Ohmeda Ltd (UK) [354403] Ohmeda House 71 Great North Road Hatfield Hertfordshire AL9 5EN England Phone: 44 (1707) Fax: 44 (1707) Internet: Datex-Ohmeda Pte Ltd (Singapore) [351978] 152 Beach Road #12-05/07 Gateway East Singapore Republic of Singapore Phone: Fax: Internet: Draeger Medical Draeger Ltd [157747] The Willows Mark Road Hemel Hempstead Hertfordshire HP2 7BW England Phone: 44 (1442) Fax: 44 (1442) Internet: Draeger Medical AG & Co KGaA [374044] Moislinger Allee Postfach 1339 D Luebeck Germany Phone: 49 (451) 8820 Fax: 49 (451) Internet: Draeger Medical Australia Pty Ltd [306071] 3 Ferntree Place Notting Hill VIC 3168 Australia Phone: 61 (1800) Fax: 61 (1800) Internet: [email protected] Draeger Medical Inc [371341] 3135 Quarry Rd Telford, PA Phone: (215) (800) Fax: (215) Internet: EKU Elektronik EKU Elektronik GmbH [306278] Am Sportplatz 23

24 D Leiningen Germany Phone: 49 (6746) 1018 Fax: 49 (6746) 8484 Internet: F Stephan F Stephan GmbH Medizintechnik [306280] Kirchstrasse 19 D Gackenbach Germany Phone: 49 (6439) Fax: 49 (6439) Internet: [email protected] F Stephan Middle East Office [428586] 81 Sulaiman Al Nabulsi Street Al Abdaly AlTayseer Building 2/Fl Amman Jordan Phone: 962 (6) Fax: 962 (6) Internet: [email protected] Stephan Polska Sp z o o [428587] ulica Sredzka 42 PL Swarzedz Poland Phone: 48 (61) Fax: 48 (61) Internet: Heinen + Loewenstein Heinen + Loewenstein GmbH [152521] Arzbacher Strasse 80 D Bad Ems Germany Phone: 49 (2603) Fax: 49 (2603) Internet: [email protected] Heyer Medical Heyer Anesthesia GmbH & Co KG [152523] Carl-Heyer-Strasse 1/3 Postfach 1345 D Bad Ems Germany Phone: 49 (2603) 7910 Fax: 49 (2603) Internet: Intermed Intermed Equipamento Medico Hospitalar Ltda [174394] Avenida Cupece 1786 Cidade Ademar Sao Paulo-SP Brazil Phone: 55 (11) Fax: 55 (11) Internet: [email protected] Kimura S Kimura Medical Instrument Co Ltd [152416] 17-5 Yushima 2-chome Bunkyo-ku Tokyo

25 Japan Phone: 81 (3) Fax: 81 (3) Internet: Medec Medec [291305] Lion d'orweg 19 B-9300 Aalst Belgium Phone: 32 (53) Fax: 32 (53) Internet: Normeca Normeca A/S [162653] Postboks 404 N-1471 Skaarer Norway Phone: 47 (67) Fax: 47 (67) Internet: Normeca Asia [321497] Kanda-Blanca Building Iwamoto Chiyoda Japan Phone: 81 (3) Penlon Penlon Ltd [139281] Abingdon Science Park Barton Lane Abingdon Oxfordshire OX14 3PH England Phone: 44 (1235) Fax: 44 (1235) Internet: Pneupac Pneupac Ltd [150970] Bramingham Business Park Enterprise Way Luton Bedfordshire LU2 4BU England Phone: 44 (1582) Fax: 44 (1582) Internet: Smiths Medical (Southeast Asia) Ltd [418055] Unit C & D 11/Fl Spectrum Tower 53 Hung To Road People's Republic of China Phone: Fax: Internet: [email protected] Royal Medical Royal Medical Co Ltd [157039] 2/Fl Sung Hwa Building Seokyo-dong Mapo-ku Seoul Republic of Korea 25

26 Phone: 82 (2) Fax: 82 (2) Internet: Samed Samed Elettromedicali srl [187040] strada Provinciale 181 N 1/B I Merlino LO Italy Phone: 39 (02) Fax: 39 (02) Internet: [email protected] Siare Siare Hospital Supplies srl [152520] via Giulio Pastore 18 I Crespellano BO Italy Phone: 39 (051) Fax: 39 (051) Internet: [email protected] Taema Taema, Sub L'Air Liquide SA [151544] 6 rue Georges Besse CE 80 F Antony Cedex France Phone: 33 (1) Fax: 33 (1) Internet: [email protected] Ulco Ulco Engineering Pty Ltd [157051] 25 Sloane Street Marrickville NSW 2204 Australia Phone: 61 (2) Fax: 61 (2) Internet: [email protected] Note: The following companies did not provide us with any product information in time for publication. Their addresses are listed as a service to our readers. Oxigel Materiais Hospitalares Industria Comercio Ltda [152447] Rua Engenheiro Jorge Oliva 155 Vila Mascote Sao Paulo-SP Brazil Phone: 55 (11) Fax: 55 (11) Internet: [email protected] K Takaoka Ind e Com Ltda [152442] Rua Bertioga 385 Saude Sao Paulo-SP Brazil Phone: 55 (11) Fax: 55 (11) Internet: [email protected] 26

27 About the chart specifications The following terms are used in the charts: Pipeline gas inlets: Many listed systems include diameter index safety system (DISS) pipeline connections and pin-indexed cylinders and yokes. Suction system: The ability to provide suction from the anesthesia machine. O fail-safe: 2 A safety device that protects the patient from inadequate O2 supply. If the O2 supply pressure drops below about 25 to 30 pounds per square inch (psi), the unit decreases or shuts off the flow of other gases and activates an. Hypoxic mixture fail-safe: A safety device that prevents an anesthesia machine from being set to dispense a hypoxic mixture. Bellows: Automatic ventilator bellows have an ascending or descending design. The bag-in-bottle principle is based on an equilibrium between the tank pressure and the bottle pressure during inspiration; during expiration, the patient exhales into the bag while the tank is refilled for the following inspiration. Ventilation modes: The modes of ventilation available with the anesthesia unit (e.g., manual ventilation, controlled mechanical ventilation, intermittent mandatory ventilation). Tidal volume, range, cc: A control adjusts the volume of individual breaths within this range. Minute volume, range, L/min: A control adjusts the total inspiratory volume per minute delivery from the bellows. Frequency, bpm: The respiratory frequency can be set within the listed range of breaths per minute. Inspiratory flow, L/min: The flow range of gas that the ventilator is capable of delivering to the patient. I:E ratio: The proportion of inspiration time to expiration time in a single respiratory cycle (expiration is usually longer than inspiration). System checks: Any check the unit can perform to ensure proper functioning of the anesthesia system. Hi-pressure : Senses high gas pressure in the patient breathing circuit. Subatmospheric pressure : Senses when pressure is below ambient level; this usually occurs during spontaneous inspiration when the patient is not receiving adequate gas or when gas is being withdrawn from the circuit (e.g., by a misadjusted scavenging system) and not replenished by an adequate fresh-gas flow. Continuing press : Senses sustained elevated airway pressure that does not periodically fall below a selectable threshold level. Installation: How the anesthesia unit is installed in the location of its intended use. Abbreviations: The following abbreviations are used in the chart: ADU Anesthesia delivery unit AGSS Anesthesia gas scavenging system ANSI American National Standards Institute 27 APL Adjustable pressure-limiting ARO After receipt of order ASTM American Society for Testing and Materials BIS Bispectral Index

28 BP Blood pressure bpm Breaths per minute BS British Standard BSI British Standards Institution CE Communaute Europeen CE mark Conformite Europeene mark CMV Controlled mechanical ventilation CPAP Continuous positive airway pressure CPU Central processing unit CRT Cathode ray tube CSA Canadian Standards Association DIN Deutsches Institut fuer Normung DIS Draft international standard ECG Electrocardiogram EEG Electroencephalogram EL Electroluminescent display EN European Norm EVC Expiratory volume control (ventilator function) FDA U.S. Food and Drug Administration ICE Integral contrast enhancement IEC International Electrotechnical Commission IMV Intermittent mandatory ventilation IPPV Intermittent positive-pressure ventilation IR Infrared ISO International Organization for Standardization IV Intravenous JIS Japanese Industrial Standard LCD Liquid crystal display LED Light-emitting diode MAC Monitored anesthesia care MDD Medical Devices Directive MRI Magnetic resonance imaging MV Minute volume Ni-Cd Nickel-cadmium OR Operating room PCV Pressure-controlled ventilation PEEP Positive end-expiratory pressure PVC Pressure/volume control SCMV Synchronized controlled mechanical ventilation SIMV Synchronized intermittent mandatory ventilation SMV Synchronized mechanical ventilation SPVC Synchronized pressure/volume control ST ECG wave segment tcco 2 Transcutaneous carbon dioxide tco 2 Transcutaneous oxygen TFT Thin-film transistor TGA Australia Therapeutic Goods Administration Ti Inspiratory time TUV Technischer Ueberwachungs Verein TV Tidal volume UL Underwriters Laboratories UPS Uninterruptible power supply VCV Modes volume control VGA Video Graphics Array Note: The data in the charts derive from suppliers specifications and have not been verified through independent testing by ECRI 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 is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information. 28

29 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. However, 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) , ext. 5265; +1 (610) (fax); or ( ). 29

30 MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED ACOMA ACOMA SPECIFICATIONS SPECIFICATIONS Basic Performance 1 High Performance 1 KMA-1300III PH-5FII WHERE MARKETED Not specified Not specified FDA CLEARANCE Not specified Not specified CE MARK (MDD) Not specified Not specified PIPELINE GAS INLETS All All 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES O2 O2, N2O, air 2 (O2, N2O) 2 (O2, N2O) VAPORIZERS, AGENTS Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Sevoflurane, isoflurane, halothane, enflurane Sevoflurane, isoflurane, halothane, enflurane Type Variable bypass Variable bypass Number Interlock Yes (if >1 vaporizer) Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Audible, visual, N2O Audible, visual, N2O Yes Yes shutoff shutoff Yes (methods vary) Yes (methods vary) 30% O2 30% O2 HYPOXIC MIXTURE FAIL-SAFE AUTOMATIC Yes Yes Yes Optional (AFR-900II : VENTILATOR ACE-3000) BELLOWS, SIZE Adult Adult : Adult/pediatric Type Motor driven Not specified Primary controls Ventilation modes Manual, spontaneous, VCV Manual, spontaneous, VCV, PCV, SIMV or pressure support Volume, manual, spontaneous Volume : CMV Tidal volume Yes Yes Range, cc 50-1, , , : 0-2, 660 Minute volume Yes Yes : Not specified Range, L/min >20 > : Not specified Frequency, bpm : Inspiratory flow, L/min : 3-40 IE ratio 1:1 to 1:3 1:0.5 to 1:5 : 1:0.1 to 1:9.9 Inspiratory pause Optional Optional 5, 10, 20, 30% Not specified Pressure limit, cm Adjustable, <70 preferred Adjustable, <70 preferred Not specified 40 : H2O PEEP, cm H2O Other controls None specified ACE-3000 has inspired time control System checks Pre-use vent, gas supply, ongoing system Pre-use leak, vent, compliance, gas supply, ongoing system None specified None specified SCAVENGING SYSTEM Active or passive Active or passive Optional Optional AUTO RECORD No Optional No No KEEPER ANESTHESIA DATA MANAGEMENT No Optional No No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 30

31 MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED ACOMA ACOMA SPECIFICATIONS SPECIFICATIONS Basic Performance 1 High Performance 1 KMA-1300III PH-5FII MONITORS Airway pressure Yes Yes Yes No : Yes Where measured Varies Varies Not specified NA : Not specified High-pressure Yes Yes Yes NA : Not specified Subatmospheric Yes Yes 5-60 cm H2O NA : Yes pressure Continuing pressure Yes Yes No NA : No Low pressure/apnea Yes Yes Not specified NA : Not specified Other pressure s Optional Optional None specified NA : None Expiratory volume/flow Yes Yes Yes No Type of sensor Varies Varies Not specified NA Where measured Varies Varies Not specified NA Rate NA NA Apnea Yes (method may vary) Yes (method may vary) No NA Reverse-flow No NA High/low minute No NA volume High/low flow No NA Other expiratory No NA s O2 concentration Yes Yes Yes Yes Type of sensor Galvanic cell Galvanic cell Response time, sec <30 <30 Not specified Not specified CO2 concentration Optional Optional No Yes Apnea Required (if CO2 Required (if CO2 NA Not specified monitoring is integral) monitoring is integral) N2O No Yes No Not specified Agent monitors No Yes Optional Optional Type of agents NA Isoflurane, halothane, enflurane,, Sevoflurane, isoflurane, halothane, enflurane Sevoflurane, isoflurane, halothane, enflurane sevoflurane Auto ID No Yes No No Agent concentration No Yes Not specified Not specified ECG No Optional No No Heart rate No Required (if ECG is NA NA integral) ST segment No Required (if ECG is NA NA integral) Noninvasive BP No Optional No No Invasive BP No Optional No No Temperature No Optional No No Pulse oximeter No Optional Not specified Not specified Other monitors None Optional None specified None specified Other features None specified None specified This is the second of three pages covering the above model(s). These specifications continue onto the next page. 31

32 MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED ACOMA ACOMA SPECIFICATIONS SPECIFICATIONS Basic Performance 1 High Performance 1 KMA-1300III PH-5FII DISPLAYS Yes Yes No No Number 1 2 NA NA Type NA NA Integrated Yes Yes NA NA Interface with others Yes Yes NA NA DATA INPUT No No PRIORITIZED ALARMS 3 (caution, advisory, 3 (caution, advisory, No No ) ) PHYSICAL FEATURES H x W x D, cm 142 x 71 x x 60 x 65 Weight, kg Shelves, cm 57 x 26 3 x 6.1 x 30, 13 x 42 x 21.5 Drawers, cm 6.5 x 25 x x 36.2 x 17.7 Writing shelf, cm 87 x 60 x x 49.5 x 25 Installation Not specified Not specified POWER REQUIRED, Not specified Not specified VAC Auxiliary outlets 4 Not specified BACKUP BATTERY Required Required No Not specified Type NA Not specified Use per charge, hr NA Not specified PURCHASE INFORMATION Price Not specified Y1,990,000 (US$16,607) for block type, Y2,010,000 (US$16,774); does not include vaporizer Warranty Not specified 1 year Service contract Not specified Not specified Delivery time, ARO Not specified Not specified OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes 1 These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on this data. Some units for use in MRI rooms may not be able to meet all "high" requirements. 1 These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on this data. None specified. Auxiliary shelves. 32

33 MODEL ACOMA ACOMA AMS AMS PRO-55 PRO-INJ WHERE MARKETED Not specified Not specified Worldwide, except North America Worldwide, except North America FDA CLEARANCE Not specified Not specified Submitted Submitted CE MARK (MDD) Not specified Not specified Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES 2 (O2, N2O) 2 (O2, N2O) Optional (O2, N2O, air) Optional VAPORIZERS, AGENTS Sevoflurane, isoflurane, halothane, enflurane Sevoflurane, isoflurane, halothane, enflurane Isoflurane, halothane, enflurane,, sevoflurane Type Variable bypass Variable bypass Temperature compensated Number 2 or Interlock Yes Yes NA Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Yes Yes Yes Yes Isoflurane, halothane, enflurane,, sevoflurane Temperature compensated HYPOXIC MIXTURE 30% O2 30% O2 Yes Yes FAIL-SAFE AUTOMATIC Optional (PRO-VmkII : Optional (PRO-55V) VENTILATOR PRO-55V) BELLOWS, SIZE Adult/pediatric Adult/pediatric Adult/pediatric Adult/pediatric Type Ascending Ascending Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes Volume : CMV, SIMV, CMV, SIMV, spontaneous CMV, PCV, SIMV, ASB CMV, PCV, SIMV, ASB spontaneous Tidal volume Yes Yes Yes Yes Range, cc 100-1,200 : 1-2, , , ,500 Minute volume Yes Yes Yes Yes Range, L/min : , , automatic , automatic Frequency, bpm 5-40 : Inspiratory flow, L/min : , automatic Adjustable in PCV Mode IE ratio 1:1 to 1:3 : 1:0.5 to 1:9.9 1:0.5 to 1:9.9 2:1 to 1:5 2:1 to 1:5 Inspiratory pause 20% or 30% 20% or 30% No User adjustable Pressure limit, cm H2O , adjustable 10-70, adjustable PEEP, cm H2O Off (0), 3-20 Off (0), 3-20 Other controls PRO-55V has inspired PRO-55V has inspired time control time control Adult/pediatric modes, MV/TV selection, integrated spirometry, fresh gas and compliance compensation Adult/pediatric modes, MV/TV selection, integrated spirometry, fresh-gas and compliance compensation System checks None specified None specified Self-verification Self-verification SCAVENGING SYSTEM Optional Optional Active or passive Active or passive AUTO RECORD No No Optional Optional KEEPER ANESTHESIA DATA MANAGEMENT Not specified Not specified Optional Optional This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 33

34 MODEL ACOMA ACOMA AMS AMS PRO-55 PRO-INJ MONITORS Airway pressure No : Yes Yes Yes Yes Where measured NA : Not specified Yes Y-piece Y-piece High-pressure NA : Yes Yes Yes Yes Subatmospheric NA : Yes Yes No No pressure Continuing pressure NA : Yes Yes Yes Yes Low pressure/apnea NA : Yes Yes Yes Yes Other pressure s NA : None None Peak Peak Expiratory volume/flow Yes Yes Yes Yes Type of sensor Not specified Not specified Spirolite Spirolite Where measured Not specified Not specified Y-piece Y-piece Rate No No Yes Yes Apnea No : Yes Yes Yes Yes Reverse-flow No No No No High/low minute volume No : Yes Yes Yes Yes High/low flow Yes : No No Yes Yes Other expiratory s Not specified Not specified Disconnection, leak, obstruction O2 concentration Yes Yes Yes Yes Type of sensor Galvanic cell Galvanic cell Galvanic cell Galvanic cell Response time, sec Not specified Not specified Not specified Not specified CO2 concentration No No Yes Yes Apnea NA NA Yes Yes N2O Not specified No Yes Yes Agent monitors Not specified No Yes Yes Type of agents Not specified Not specified Isoflurane, halothane, enflurane,, sevoflurane Auto ID No No Yes Yes Agent concentration Not specified Not specified Yes Yes ECG No No Yes Yes Heart rate NA NA Yes Yes ST segment NA NA Yes Yes Noninvasive BP No No Yes Yes Invasive BP No No Yes Yes Temperature No No Yes Yes Pulse oximeter No No Yes Yes Other monitors None specified None specified Arrhythmia, respiration rate, 5/12 ECG, BIS Other features None specified None specified Trends, printing, networking Disconnection, leak, obstruction Isoflurane, halothane, enflurane,, sevoflurane Arrhythmia, respiration rate, 5/12 ECG, BIS Trends, printing, networking This is the second of three pages covering the above model(s). These specifications continue onto the next page. 34

35 MODEL ACOMA ACOMA AMS AMS PRO-55 PRO-INJ DISPLAYS Yes Yes Yes Yes Number Not specified Not specified 1 1 Type LED LED Color TFT Color TFT Integrated No No Yes Yes Interface with others No No Yes Yes DATA INPUT No No Membrane switches, ComWheel, knobs Membrane switches, ComWheel, knobs PRIORITIZED ALARMS Yes Yes 3 (caution, advisory, warning) 3 (caution, advisory, warning) PHYSICAL FEATURES H x W x D, cm 148 x 70 x x 70 x x 58 x x 70 x 82 Weight, kg Shelves, cm 61 x x x x 34 (top shelf) Drawers, cm 30 x 28.5 x x 28.5 x x 37 x 37 (4 maximum) 10.5 x 37 x 37 (4 maximum) Writing shelf, cm 12.5 x 28.5 x x 28.5 x x x 37 Installation Not specified Not specified Mobile Mobile POWER REQUIRED, Not specified Not specified , optional /240, optional VAC Auxiliary outlets Not specified Not specified 2 2 BACKUP BATTERY Not specified Not specified Yes Yes Type Not specified Not specified Rechargeable Rechargeable Use per charge, hr Not specified Not specified Up to 2 1 PURCHASE INFORMATION Price Not specified Not specified 18,000 (US$20,745) without monitor 20,000 ($US23,051) without monitor Warranty 1 year 1 year 2 years 2 years Service contract Not specified Not specified Yes Yes Delivery time, ARO Not specified Not specified 2-3 weeks 2-3 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes None specified. None specified. Alternative gas supply per end-user requirements; illuminated flowmeter. Alternative gas supply per end-user requirements; illuminated flowmeter; air/n2o selection valve. 35

36 MODEL AMS ANMEDIC ANMEDIC ANMEDIC 300 Falcon Falcon SE Hawk WHERE MARKETED Worldwide, except North Worldwide, except USA Worldwide, except USA Worldwide, except USA America FDA CLEARANCE Submitted No No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES Optional Up to 4 (O2, N2O, air) Up to 4 (O2, N2O, air) Optional VAPORIZERS, AGENTS Type Isoflurane, halothane, enflurane,, sevoflurane Temperature Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Variable bypass Variable bypass Variable bypass compensated Number 3 1 or 2 1 or 2 1 Interlock Yes In vaporizer In vaporizer In vaporizer SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Yes Yes Yes Yes HYPOXIC MIXTURE Yes Ratio system Ratio system Ratio system FAIL-SAFE AUTOMATIC 8500 Optional Kestrel Yes Optional Anevent VENTILATOR BELLOWS, SIZE Adult/pediatric Adult Adult Adult Type Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes CMV, PCV, SIMV, ASB Manual, CMV, PCV, Manual, CMV, PCV, SIMV Manual, CMV optional SIMV Tidal volume Yes Yes Yes Yes Range, cc 20-1, , ,500 Up to 1,500 Minute volume Yes No No No Range, L/min , automatic NA NA NA Frequency, bpm Inspiratory flow, L/min Adjustable in PCV mode IE ratio 2:1 to 1:5 3:1 to 1:9.9 3:1 to 1:9.9 1:1, 1:2, 1:3 Inspiratory pause User adjustable Adjustable inspiratory flow Adjustable inspiratory flow No Pressure limit, cm H2O 10-70, adjustable PEEP, cm H2O Off (0), Optional 2-20 Other controls Adult/pediatric modes, MV/TV selection, integrated spirometry, fresh gas and compliance compensation Fresh gas and compliance compensation Fresh gas and compliance compensation None System checks Self-verification Automated-instructed ventilator and breathing system check Automated-instructed ventilator and breathing system check SCAVENGING SYSTEM Active or passive Exhaust or passive AGSS Exhaust or passive AGSS Exhaust or passive AGSS AUTO RECORD Optional No No No KEEPER ANESTHESIA DATA MANAGEMENT Optional Serial RS232 output Serial RS232 output No Manual This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 36

37 MODEL AMS ANMEDIC ANMEDIC ANMEDIC 300 Falcon Falcon SE Hawk MONITORS Airway pressure Yes Yes Yes Yes Where measured Y-piece Expiratory limb Expiratory limb Bellows High-pressure Yes Adjustable Adjustable Adjustable Subatmospheric No Yes Yes No pressure Continuing pressure Yes Yes Yes No Low pressure/apnea Yes Yes Yes No Other pressure s Peak System pressure System pressure None Expiratory volume/flow Yes No Yes No Type of sensor Spirolite NA Differential pressure NA Where measured Y-piece NA Bellows inlet NA Rate Yes NA No NA Apnea Yes NA No NA Reverse-flow No NA No NA High/low minute Yes NA Yes NA volume High/low flow Yes No No No Other expiratory Disconnection, leak, No No No s obstruction O2 concentration Yes No Optional No Type of sensor Galvanic cell NA Galvanic cell NA Response time, sec Not specified NA Not specified NA CO2 concentration Yes No No No Apnea Yes NA NA NA N2O Yes No No No Agent monitors Yes No No No Type of agents Isoflurane, halothane, NA NA NA enflurane,, sevoflurane Auto ID Yes NA NA NA Agent concentration Yes NA NA NA ECG Yes No No No Heart rate Yes NA NA NA ST segment Yes NA NA NA Noninvasive BP Yes No No No Invasive BP Yes No No No Temperature Yes No No No Pulse oximeter Yes No No No Other monitors Arrhythmia, respiration None None None rate, 5/12 ECG, BIS Other features Trends, printing, networking None Numeric ventilator trends None This is the second of three pages covering the above model(s). These specifications continue onto the next page. 37

38 MODEL AMS ANMEDIC ANMEDIC ANMEDIC 300 Falcon Falcon SE Hawk DISPLAYS Yes Yes Yes No Number NA Type Color TFT LED, bar graph Color TFT (16.3 cm [6.4"]) NA Integrated Yes Yes Yes NA Interface with others Yes NA No NA DATA INPUT Membrane switches, No No No ComWheel, knobs PRIORITIZED ALARMS 3 (caution, advisory, Yes Yes No warning) PHYSICAL FEATURES H x W x D, cm 150 x 80 x x 85 (69, frame) x x 86 (70, frame) x x 75 (63, frame) x 72 (with trolley) Weight, kg with ventilator with ventilator Shelves, cm 34 x 34 (top shelf) 38 x 35, optional 61 x x x 35 Drawers, cm 10.5 x 37 x 37 (4 50 x 30 x 10 (3 maximum) 47 x 33 x 11 (3 maximum) 42 x 30 x 10 (3 maximum) maximum) Writing shelf, cm 37 x x x 30 (tabletop) None Installation Mobile Mobile Mobile Mobile or wall POWER REQUIRED, 220/240, optional , , , VAC Auxiliary outlets BACKUP BATTERY Yes Yes Yes No Type Rechargeable Lead acid Lead acid NA Use per charge, hr NA PURCHASE INFORMATION Price 22,000 (US$25,359) Not specified Not specified Not specified without monitor Warranty 2 years 1 year 1 year 1 year Service contract Yes Not specified Not specified Not specified Delivery time, ARO 2-3 weeks Not specified Not specified Not specified OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Alternative gas supply per end-user requirements; illuminated flowmeter. Auxiliary gas outlets; lamp. Pull-out writing surface; lamp; auxiliary gas outlets. Auxiliary gas outlets. 38

39 MODEL ANMEDIC BLEASE BLEASE BLEASE Kite Frontline Genius/Genius MRI Frontline Plus 440 : Plus 560 : Plus 690 Frontline Sirius 1000 : 2000 WHERE MARKETED Worldwide, except USA Worldwide Worldwide Worldwide FDA CLEARANCE No Yes Yes (560 submitted) Not specified CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES 3 optional (O2, N2O, air) 2 maximum 3 maximum : 4 maximum : 5 maximum 2 VAPORIZERS, AGENTS Isoflurane, halothane, enflurane,, sevoflurane Sevoflurane, isoflurane, halothane, enflurane Sevoflurane, isoflurane, halothane, enflurane Sevoflurane, isoflurane, halothane, enflurane Type Variable bypass Plenum-type variable bypass, fully compensated Plenum-type variable bypass, fully compensated Plenum-type variable bypass, fully compensated Number 1 or 2 1 maximum 3 maximum 2 maximum Interlock In vaporizer Fully compatible Fully compatible Fully compatible SUCTION SYSTEM Optional Optional, direct/venturi Optional, direct/venturi Optional, direct/venturi O2 FAIL-SAFE Yes Alarm Multigas cutoff, full s Multigas cutoff, full s HYPOXIC MIXTURE FAIL-SAFE AUTOMATIC Optional Anevent 2200 Blease 8500 (not FDA Blease 6700 VENTILATOR approved) BELLOWS, SIZE Adult Adult/pediatric Adult/pediatric Adult/pediatric Type Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Ratio system Gear-driven ratio system 1 Gear-driven ratio system 1 Gear-driven ratio system 1 Primary controls Ventilation modes Manual, CMV Adult, pediatric, CMV Adult, pediatric, SIMV, CMV, PCV, PLV 2 Adult, pediatric, SIMV, CMV, PCV, PLV 2 Tidal volume Yes Yes Yes Yes Range, cc Up to 1, , , ,600 Minute volume No Yes Yes Yes Range, L/min NA Frequency, bpm Inspiratory flow, L/min , variable 0-100, variable IE ratio 1:1, 1:2, 1:3 Not specified 2:1 to 1:5 2:1 to 1:5 Inspiratory pause No NA 25% 25% Pressure limit, cm , adjustable 10-70, adjustable 10-70, adjustable H2O PEEP, cm H2O Optional variable 0-20 electronic variable PEEP 0-20 electronic variable PEEP Other controls None Adult and pediatric modes, standby, MV/TV selection Adult and pediatric modes, standby in both modes, spirometry MV/TV Adult and pediatric modes, standby in both modes, spirometry MV/TV selection 3 System checks Manual Self-verification test Self-verification and leak test, compliance, compensation selection 3 Self-verification and leak test, compliance, compensation SCAVENGING SYSTEM Exhaust or passive AGSS Active AGSS Active vacuum or exhaust AGSS Active vacuum or exhaust AGSS AUTO RECORD No Optional Optional Optional KEEPER ANESTHESIA DATA MANAGEMENT No Optional Optional Optional This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 39

40 MODEL ANMEDIC BLEASE BLEASE BLEASE Kite Frontline Genius/Genius MRI Frontline Plus 440 : Plus 560 : Plus 690 Frontline Sirius 1000 : 2000 MONITORS Airway pressure Yes Peak and mean Peak and mean Peak and mean Where measured Bellows Y-piece Y-piece Y-piece High-pressure Adjustable cm H2O 70 to -4 cm H2O 70 to -4 cm H2O Subatmospheric pressure No Not specified -10 cm H2O, fixed, internal -10 cm H2O, fixed, internal Continuing pressure No PEEP referenced PEEP referenced PEEP referenced Low pressure/apnea No 5-60 cm 70 to -4 cm H2O 70 to -4 cm H2O Other pressure s None Not specified Low-pressure 5-60 cm H2O, adjustable, apnea 4 Low-pressure 5-60 cm H2O, adjustable, apnea 4 Expiratory volume/flow No Not specified MV and TV MV and TV Type of sensor NA Not specified Spirolite expiratory volume Spirolite expiratory volume Where measured NA Not specified Circuit Circuit Rate NA Not specified Yes Yes Apnea NA Not specified Low expired volume Low expired volume Reverse-flow NA Not specified No No High/low minute NA Not specified Yes Yes volume High/low flow No Not specified Yes Yes Other expiratory s No Not specified High expired volume High expired volume O2 concentration No Adjustable Adjustable s Adjustable s Type of sensor NA Galvanic cell Galvanic cell Galvanic cell Response time, sec NA Not specified Not specified Not specified CO2 concentration No Not specified Optional Optional Apnea NA Not specified Optional Optional N2O No Not specified Optional Optional Agent monitors No Not specified Optional Optional Type of agents NA Not specified Not specified Not specified Auto ID NA Not specified Optional Optional Agent concentration NA Not specified Optional Optional ECG No Not specified Optional Optional Heart rate NA Not specified Optional Optional ST segment NA Not specified Optional Optional Noninvasive BP No Not specified Optional Optional Invasive BP No Not specified Optional Optional Temperature No Not specified Optional Optional Pulse oximeter No Not specified Optional Optional Other monitors None None specified None specified None specified Other features None None specified User-definable defaults, language option, waveform, bar graph User-definable defaults, language option, waveform, bar graph This is the second of three pages covering the above model(s). These specifications continue onto the next page. 40

41 MODEL ANMEDIC BLEASE BLEASE BLEASE Kite Frontline Genius/Genius MRI Frontline Plus 440 : Plus 560 : Plus 690 Frontline Sirius 1000 : 2000 DISPLAYS No Not specified Optional Optional Number NA Not specified Not specified Not specified Type NA Not specified Not specified Not specified Integrated NA Not specified No No Interface with others NA Not specified Yes Yes DATA INPUT No Not specified No No PRIORITIZED ALARMS No Not specified Optional Optional PHYSICAL FEATURES H x W x D, cm 148 x 75 (63, frame) x x 40 x x [50 : 62 : 79] x x 69 x 25 : 149 x 50 x 62 Weight, kg 90 with ventilator : 104 : 130, without patient monitors 30 : 68; without patient monitors Shelves, cm 63 x 35 1, not specified [50 : 62 : 75] x 44 (2), [45 : NA : 46 x : 74] x 50 (1) Drawers, cm 42 x 30 x 10 (3 maximum) Optional 1, not specified 35 x 10 x 35 (4 maximum) 35 x 10 x 35 (4 maximum) Writing shelf, cm 43 x 29 Not specified 26 x 35 pull-out writing NA : 46 x 23 table (1) Installation Mobile Mobile, wall, pendant Mobile, wall, ceiling Wall, pendant : Mobile POWER REQUIRED, , Battery powered 110/120/220/ VAC Auxiliary outlets BACKUP BATTERY No Yes Yes Yes Type NA AA Not specified Internal Use per charge, hr NA Not specified 2 2 PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Not specified Optional Optional Optional Delivery time, ARO Not specified Not specified Varies Varies OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Auxiliary gas outlets. MRI compatibility up to 1,000-gauss line. 1 Rotameter controls are knock resistant with a guard in front of them. 2 Includes cylinder box and pipelines; excludes trolley and wall mounting. Integral O2 monitor with backlight and dimming facility; pull-out writing table with pre-use checklist; storage space for range of circle absorbers; footrest; footbrake; rear handle; rear bumper; wipe-clean angled gauges. Meets the requirements of ANSI, ASTM, BS 5724, BSI, CSA, DIN, IEC 601, and ISO. 1 1 vaporizer connected to the ventilator and up to 3 vaporizers in parking. 2 Also spontaneous, sigh, pause, and pressure support. 3 Fresh gas compensated. 4 Also pressure cycling and low supply-gas pressure. Integral O2 monitor; flowmeter backlight; swing-out writing table with pre-use checklist; footbrake; siderails with integral handle; wipeclean angled gauges. Meets the requirements of ANSI, ASTM, BS 5724, BSI, CSA, DIN, IEC 601, and ISO. 1 1 vaporizer connected to the ventilator and up to 3 vaporizers in parking. 2 Also spontaneous, sigh, pause, and pressure support. 3 Fresh gas compensated. 4 Also pressure cycling and low supply-gas pressure. 41

42 MODEL BLEASE DAMECA DAMECA DAMECA Frontline Sirius 3000 DREAM Siesta Breasy Siesta Whispa WHERE MARKETED Worldwide Worldwide, except North America Worldwide, except North America Worldwide, except North America FDA CLEARANCE 510k No No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) Yes Yes Yes GAS CYLINDER YOKES 4 maximum 1 or 2 Optional Optional VAPORIZERS, AGENTS Sevoflurane, isoflurane, halothane, enflurane Temperature Temperature Type Plenum-type variable bypass, fully compensated compensated compensated Number 2 maximum 1 or 2 1, 2 or 3 1, 2 or 3 Interlock Fully compatible Yes Yes Yes SUCTION SYSTEM Direct/venturi Optional Optional Optional O2 FAIL-SAFE Multigas cutoff, full s Yes Yes Yes Temperature compensated HYPOXIC MIXTURE Gear-driven ratio system 1 Yes Yes Yes FAIL-SAFE AUTOMATIC Blease 8700 Yes Yes Yes VENTILATOR BELLOWS, SIZE Adult/pediatric Adult Adult/pediatric Adult Type Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes Adult, pediatric, SIMV, Manual, CMV, PLV, SIMV Manual, controlled, Manual, VCV, PCV, SIMV CMV, PCV, PLV 2 mechanical Tidal volume Yes Yes Yes Yes Range, cc 20-1, ,500, 50-1, , ,500 Minute volume Yes Yes Yes Yes Range, L/min Frequency, bpm Inspiratory flow, L/min 0-100, variable IE ratio 2:1 to 1:5 3:1, 1:9 3:1 to 1:9.9 3:1 to 1:9.9 Inspiratory pause 25% Plateau Not specified 0-70% Pressure limit, cm 10-70, adjustable H2O PEEP, cm H2O 0-20 electronic variable 3-20 Optional 1-3 PEEP Other controls Adult and pediatric modes, standby in both modes, spirometry MV/TV selection 3 Fresh gas and compliance compensated None specified Fresh-gas and compliance compensated System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Self-verification and leak test, compliance, compensation Active vacuum or exhaust AGSS Self-test including leak test None specified Self-test including leak test Active AGSS Active AGSS Active AGSS Optional No No No Optional No No No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 42

43 MODEL BLEASE DAMECA DAMECA DAMECA Frontline Sirius 3000 DREAM Siesta Breasy Siesta Whispa MONITORS Airway pressure Peak and mean No No No Where measured Y-piece NA NA NA High-pressure 70 to -4 cm H2O NA NA NA Subatmospheric -10 cm H2O, fixed, NA NA NA pressure internal Continuing pressure PEEP referenced NA NA NA Low pressure/apnea 70 to -4 cm H2O NA NA NA Other pressure s Low-pressure 5-60 cm NA NA NA H2O, adjustable, apnea 4 Expiratory volume/flow MV and TV No No No Type of sensor Spirolite expiratory volume NA NA NA Where measured Circuit NA NA NA Rate Yes NA NA NA Apnea Low expired volume NA NA NA Reverse-flow No NA NA NA High/low minute Yes NA NA NA volume High/low flow Yes NA NA NA Other expiratory High expired volume NA NA NA s O2 concentration Adjustable s No Yes, with ventilator No Type of sensor Galvanic cell NA NA NA Response time, sec Not specified NA NA NA CO2 concentration Optional No No No Apnea Optional NA NA NA N2O Optional No No No Agent monitors Optional No No No Type of agents Not specified NA NA NA Auto ID Optional NA NA NA Agent concentration Optional NA NA NA ECG Optional No No No Heart rate Optional NA NA NA ST segment Optional NA NA NA Noninvasive BP Optional No No No Invasive BP Optional No No No Temperature Optional No No No Pulse oximeter Optional Not specified Not specified Not specified Other monitors None specified None specified None specified None specified Other features User-definable defaults, language option, waveform, bar graph None specified None specified None specified This is the second of three pages covering the above model(s). These specifications continue onto the next page. 43

44 MODEL BLEASE DAMECA DAMECA DAMECA Frontline Sirius 3000 DREAM Siesta Breasy Siesta Whispa DISPLAYS Optional Yes Yes Yes Number Not specified 1 + patient monitor Not specified 1 + patient monitor Type Not specified 10" color VGA LCD (12.7 cm) [5"]) LCD (17.8 cm) [7"]) Integrated No Yes Yes Yes Interface with others Yes Yes No Yes DATA INPUT No Keyboard Keyboard Keyboard PRIORITIZED ALARMS Optional Yes Yes Yes PHYSICAL FEATURES H x W x D, cm 148 x 75 x x 80 x x 64 x x 64 x 68 Weight, kg 110; without patient monitors Shelves, cm 46 x x x x 40 Drawers, cm 35 x 10 x 35 (4 maximum) 55 x x x 40 Writing shelf, cm 35 x 34 swing-out writing 20 x x x 30 table Installation Mobile, pendant Mobile Mobile Mobile POWER REQUIRED, / / /230 VAC Auxiliary outlets BACKUP BATTERY Yes Yes Yes Yes Type internal Rechargeable Rechargeable Rechargeable Use per charge, hr PURCHASE INFORMATION Price Not specified $30,000 Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Optional Not specified Not specified Not specified Delivery time, ARO Varies Not specified Not specified Not specified OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Integral O2 monitor; flowmeter backlight; swing-out writing table with pre-use checklist; footbrake; siderails with integral handle; wipeclean angled gauges. Meets the requirements of ANSI, ASTM, BS 5724, BSI, CSA, DIN, IEC 601, and ISO. 1 1 vaporizer connected to the ventilator and up to 3 vaporizers in parking. 2 Also spontaneous, sigh, pause, and pressure support. 3 Fresh gas compensated. 4 Also pressure cycling and low supply-gas pressure. Ergonomic design; heightadjustable table; plate/patient systems; patient monitor. Meets requirements of IEC and ISO Meets requirements of IEC and ISO Meets requirements of IEC and ISO

45 MODEL DAMECA DATASCOPE DATASCOPE DATEX-OHMEDA/ GE HEALTHCARE SNOOZE ANESTAR Plus ANESTAR S Aestiva MRI WHERE MARKETED Worldwide, except North Australia, South America, Australia, South America, Worldwide America USA USA FDA CLEARANCE No Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS Yes 3 (O2, N2O, air) 2 (O2, N2O), optional air 4 optional (O2, N2O, air) GAS CYLINDER YOKES No 3 (O2, N2O, air or O2 with 2 additional) 2 (O2, N2O) 4 optional (O2, N2O, air, CO2, heliox) VAPORIZERS, AGENTS Type Temperature compensated halothane, isoflurane Variable bypass Variable bypass Tec 7 temperature, flow, pressure compensated, EZ Fill Number Interlock Yes Yes Yes Yes SUCTION SYSTEM No Optional Optional Optional O2 FAIL-SAFE Yes Yes Yes Pneumatic HYPOXIC MIXTURE Yes Ratio system, minimum Ratio system, minimum Mechanical link FAIL-SAFE volume of 25% O2 volume of 25% O2 AUTOMATIC No Yes Yes 7900 VENTILATOR BELLOWS, SIZE None 1,400 ml 1,400 ml 1,500 ml Type NA Bag in bottle Bag in bottle Ascending, standing, multibreath Primary controls Ventilation modes NA Manual and spontaneous, CMV, CMV with sigh, PCV, pressure support for pediatrics and adults Manual and spontaneous, CMV, CMV with sigh, pressure support for pediatrics and adults Tidal volume NA Yes Yes 1,500 ml Range, cc NA 40-1, , ,500 Minute volume NA Yes Yes Yes Range, L/min NA 20 maximum 20 maximum Frequency, bpm NA Inspiratory flow, L/min NA VCV, PCV, SIMV-VC, SIMV-PC, PSVPro, CPAP IE ratio NA 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 2:1 to 1:8 1:4, 1:5, 4:1, 3:1, 2:1 1:4, 1:5, 4:1, 3:1, 2:1 Inspiratory pause NA Off, 0-20% or 0-30% Off, 0-20% or 0-30% 0-60% Ti Pressure limit, cm NA H2O PEEP, cm H2O NA 3-20 CMV, 3-10 PCV 3-20 CMV, 3-10 PCV 4-30 electronic Other controls NA Pressure support trigger (-1, -2, -3, -4, -5, -6 cm H2O) Pressure support trigger (-1, -2, -3, -4, -5, -6 cm H2O) Float-type flowmeters, breath-to-breath tidal volume compensation System checks NA Auto at start-up Auto at start-up Manual pre-use test, ventilator self-test SCAVENGING SYSTEM None Optional passive Optional passive Active, passive, or open reservoir AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT No Optional data output Data output available Optional using Centricity No Optional data output Data output available Optional using Centricity This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 45

46 MODEL DAMECA DATASCOPE DATASCOPE DATEX-OHMEDA/ GE HEALTHCARE SNOOZE ANESTAR Plus ANESTAR S Aestiva MRI MONITORS Airway pressure No Yes Yes Yes Where measured NA Inspiratory port Inspiratory port Inspiratory limb High-pressure NA Yes Yes Adjustable Subatmospheric NA Yes Yes Yes pressure Continuing pressure NA Yes Yes Yes Low pressure/apnea NA Yes Yes Yes Other pressure s NA Disconnect, high Disconnect, high Not specified PEEP PEEP Expiratory volume/flow No Yes Yes Yes Type of sensor NA Hot-wire anemometer Hot-wire anemometer Differential press Where measured NA Expiratory port Expiratory port Expiratory port Rate NA No No No Apnea NA Yes Yes Yes Reverse-flow NA No No Yes High/low minute NA Yes Yes Yes volume High/low flow NA No No Yes Other expiratory NA Low tidal volume Low tidal volume Circuit leak s O2 concentration No Yes Yes Yes 1 Type of sensor NA Galvanic cell Galvanic cell Fuel cell Response time, sec NA <15 15 <35 CO2 concentration No Yes, with optional monitor Yes, with optional monitor Optional Maglife CPlus 2 Apnea NA Yes, with optional monitor Yes, with optional monitor Yes N2O No Yes, with optional monitor Yes, with optional monitor Yes, with above Agent monitors No Yes, with optional monitor Yes, with optional monitor Yes, with above Type of agents NA Auto ID NA Yes, with optional gas Yes, with optional gas No module module Agent concentration NA Yes, with optional gas Yes, with optional gas Yes module module ECG No Yes, with optional monitor Yes, with optional monitor 3-lead Heart rate NA Yes, with optional monitor Yes, with optional monitor bpm ST segment NA Yes, with optional monitor Yes, with optional monitor No Noninvasive BP No Yes, with optional monitor Yes, with optional monitor Yes Invasive BP No Yes, with optional monitor Yes, with optional monitor Yes Temperature No Yes, with optional monitor Yes, with optional monitor Yes Pulse oximeter No Yes, with optional monitor Yes, with optional monitor Yes Other monitors None None None None Other features None specified None None ECG gating, wireless compatible, up to 3 Tesla All 5 This is the second of three pages covering the above model(s). These specifications continue onto the next page. 46

47 MODEL DAMECA DATASCOPE DATASCOPE DATEX-OHMEDA/ GE HEALTHCARE SNOOZE ANESTAR Plus ANESTAR S Aestiva MRI DISPLAYS No Yes Yes 7900 Number NA Type NA EL EL ICE Integrated NA Yes Yes Yes Interface with others NA No No RS232 and DIS DATA INPUT No Touchscreen Touchscreen No PRIORITIZED ALARMS No Not specified Not specified 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 40 x 27 x x 71 x x 56 x x 73.6 x 76 Weight, kg Shelves, cm None 47 x 26.7 (top) 47 x 26.7 top shelf 10.8 x 38.5 x 26 Drawers, cm None 3 total: 18.7 x 21.9 x x 19 x x 26 (top 2); 10.9 x 46.4 x 44 (bottom) Writing shelf, cm None 91.4 x 42.5 x x 47 x 48, optional 26.5 x 31.5 extension Installation Portable Trolley Trolley Mobile with locking casters (footrest) POWER REQUIRED, Not specified 120, , /120; optional 220/240 VAC Auxiliary outlets Not specified 4 4 None BACKUP BATTERY Not specified Yes Yes In ventilator Type Not specified Sealed lead-acid Sealed lead-acid Lead acid Use per charge, hr Not specified with ventilator 0.5 maximum load PURCHASE INFORMATION Price Not specified Not specified Not specified $55,000-65,000 Warranty 1 year 1 year 1 year 1 year; 3 years, vaporizer Service contract Not specified 1-6 years 1-6 years Available Delivery time, ARO Not specified ~30 days ~30 days 2-6 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes None specified. EZ-FLOW heated breathing system 35 C; adult and pediatric ventilation modes: auto compliance compensation, fresh gas decoupling, electronic PEEP. 2 1:4 and 1:5 for CMV only. EZ-FLOW heated breathing system 35 C; adult and pediatric ventilation modes: auto compliance compensation, fresh gas decoupling, and electronic PEEP. Gauss ; vaporizer storage brackets; breathing system/bag s; number of cylinder yokes and gases; auxiliary common gas outlet; Bain module; oxygen flowmeter; IV poles; additional shelf; CastrGard; integrated suction. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 The Datex-Ohmeda Link 25 hypoxic guard precludes setting hypoxic O2 flow ratios. 2 Datex- Ohmeda is the U.S. distributor for the Schilmer Maglife CPlus MRIcompatible monitor. 3 Plus up to 3 optional screens on the S/5 AM. 47

48 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE ADU Carestation Aespire Aespire 7900 Aestiva 7100 WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE Yes Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, air, optional N2O) 3 (O2, N2O, air) 3 (O2, N2O, air); up to 4 GAS CYLINDER YOKES 3 (O2, N2O, air) 2 (O2; optional N2O and air) 2 (O2 plus air or N2O) 5 (O2, N2O, air, CO2, heliox) VAPORIZERS, AGENTS Type Aladin cassette Tec 7 temperature, flow, pressure compensated, EZ Fill Tec 7 temperature, flow, pressure compensated, EZ Fill Number or 3 Interlock Yes Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Electronic Pneumatic Pneumatic Pneumatic Tec 7 temperature, flow, pressure compensated, EZ Fill HYPOXIC MIXTURE Electronic, includes Mechanical link Mechanical link Mechanical link FAIL-SAFE agents AUTOMATIC S/5 ADU VENTILATOR BELLOWS, SIZE 1,400 ml 1,500 ml 1,500 ml 1,500 ml Type Ascending, standing, multibreath Ascending, standing, multibreath Ascending, standing, multibreath Ascending, standing, multibreath Primary controls Ventilation modes VCV, PCV, SIMV, PSV VCV, optional PCV VCV, PCV, SIMV-PC, VCV, optional PCV PSVPro, CPAP Tidal volume Yes 1,500 ml 1,500 ml 1,500 ml Range, cc 20-1, , , ,500 Minute volume No Yes Yes Yes Range, L/min NA Frequency, bpm Inspiratory flow, L/min IE ratio 2:1 to 1:4.5 2:1 to 1:6 2:1 to 1:8 2:1 to 1:6 Inspiratory pause 0-60% Ti 0-60% Ti 0-60% Ti 0-60% Ti Pressure limit, cm H2O PEEP, cm H2O Off or 4-20 integrated 4-30 electronic 4-30 electronic 4-30 electronic Other controls Float-type flowmeters, breath-to-breath tidal volume compensation Float-type flowmeters, breath-to-breath tidal volume compensation Float-type flowmeter, breath-to-breath tidal volume compensation Float-type flowmeters, breath-to-breath tidal volume compensation System checks Electronic, semi-automatic Manual pre-use test, ventilator self-test Manual pre-use test, ventilator self-test Manual pre-use test, ventilator self-test SCAVENGING SYSTEM Active or passive Active, passive, or open reservoir Active, passive, or open reservoir Active, passive, or open reservoir AUTO RECORD Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity KEEPER ANESTHESIA DATA MANAGEMENT Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 48

49 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE ADU Carestation Aespire Aespire 7900 Aestiva 7100 MONITORS Airway pressure Yes Yes Yes Yes Where measured Airway, bellows base Inspiratory limb Inspiratory limb Inspiratory limb High-pressure Adjustable Adjustable Adjustable Adjustable Subatmospheric Yes Yes Yes Yes pressure Continuing pressure Yes Yes Yes Yes Low pressure/apnea Yes Yes Yes Yes Other pressure s Pressure release, others Not specified PEEP high PEEP high Expiratory volume/flow Yes Yes Yes Yes Type of sensor Pilot tube Differential press Differential press Differential press Where measured Airway Expiratory port Expiratory port Expiratory port Rate 4-35 adult, 4-50 pediatric No No No Apnea Yes Yes Yes Yes Reverse-flow Yes Yes Yes Yes High/low minute Yes Yes Yes Yes volume High/low flow Yes Yes Yes Yes Other expiratory Compliance, resistance Circuit leak Circuit leak Circuit leak s O2 concentration Yes Yes 1 Yes 1 Optional 1 Type of sensor Paramagnetic Fuel cell Fuel cell Fuel cell Response time, sec 10-90% in 5 sec <35 <35 <35 CO2 concentration Optional Optional Optional Optional Ultima or S/5 AM Apnea Yes Yes Yes Yes N2O Yes Yes, with above Yes, with above Yes, with above Agent monitors Yes Yes, with above Yes, with above Yes, with above Type of agents All 5, plus mixtures All 5, plus mixture All 5, plus mixture All 5, plus mixture Auto ID Yes Yes Yes Yes Agent concentration Separate by agent Yes Yes Yes ECG 3-, 5-, or 12-lead 3-, 5-, or 12-lead 3-, 5-, or 12-lead 3-, 5-, or 12-lead Heart rate bpm bpm bpm bpm ST segment -6 to +6-6 to +6-6 to +6-6 to +6 Noninvasive BP 15 to 260 mm Hg 15 to 260 mm Hg 15 to 260 mm Hg 15 to 260 mm Hg Invasive BP -40 to 320 mm Hg -40 to 320 mm Hg -40 to 320 mm Hg -40 to 320 mm Hg Temperature C or F up to 4 C or F up to 4 C or F, up to 4 C or F, up to 4 Pulse oximeter Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Other monitors Respiration, NMT 1 Respiration, NMT 2 Respiration, NMT 2 Respiration, NMT 2 Other features Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring This is the second of three pages covering the above model(s). These specifications continue onto the next page. 49

50 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE ADU Carestation Aespire Aespire 7900 Aestiva 7100 DISPLAYS Yes Number 1-4 each 1 (12 x 9.2 cm [4.7 x (120 x 92 mm) in]) Type Color LCD LCD monochrome ICE LCD monochrome 3 Integrated Two 31.8 cm (12.5") Yes Yes Yes Interface with others RS232 RS232 RS232 and DIS RS232 DATA INPUT No No No No PRIORITIZED ALARMS 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 154 x not specified x not 137 x 72.5 x x 75 x x 75 x 83 specified Weight, kg , 154 Shelves, cm 38.1 x x 40 [47.5 : 67.5 : 87.5] x 41 [47.5 : 67.5 : 87.5] x 41 Drawers, cm 14.5 x 48 x 40.5, up to 4 2, each 17.5 x 33 x x 38.5 x 26; optional 10.5 x 38.5 x x 38.5 x 26 Writing shelf, cm 51 x 35.3 Not specified 31.5 x x 26.5 Installation Mobile with locking casters (footrest) Mobile with locking casters Mobile with locking casters Mobile with locking casters (footrest) 4 POWER REQUIRED, 110/120; optional 220/ /120; optional 220/ /120, optional 220/ /120; optional 220/240 VAC Auxiliary outlets Not specified 4 with individual circuit breakers 4 with individual circuit breakers 4 with individual circuit breakers BACKUP BATTERY In ventilator and UPS In ventilator In ventilator In ventilator Type Sealed lead-acid Lead acid Sealed lead-acid Lead acid Use per charge, hr maximum load maximum load PURCHASE INFORMATION Price $78,000-98,000 $32,000-35,000 $40,000-55,000 $35,000-45,000 Warranty 1 year 1 year 1 year; 3 years, vaporizer 1 year Service contract Available Available Available Available Delivery time, ARO 3-6 weeks 2-6 weeks 2-6 weeks 2-6 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes 2.5 liter volume in vent mode; Aladin cassette holder; bag hose arm; aux oxygen; integrated and external lights; IV poles; CastrGards; mounting; optional suction. Meets requirements of ASTM, CSA, EN 740, and UL. 1 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 2.7 liter volume in vent mode; vaporizer storage brackets; breathing system/bag s; number of cylinder yokes; auxiliary common gas, oxygen flowmeter, and lights; IV poles; CastrGard; integrated suction; mountings; 2 vaporizer configurations. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 The Datex-Ohmeda Link 25 hypoxic guard precludes setting hypoxic O2 flow ratios. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 2.7 liter volume in vent mode; vaporizer storage brackets; breathing system/bag s; number of cylinder yokes and gases; auxiliary common gas outlet; oxygen flowmeter; IV poles; CastrGard; integrated suction. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 Available with Datex- Ohmeda S/5 AM anesthesia monitoring system. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 5.5 liter volume in vent mode; vaporizer storage bracket; 2- or 3-vaporizer configurations; breathing system/bag s; auxiliary common gas outlet; number of cylinder yokes; integrated suction and auxiliary oxygen flowmeter; Bain module; auxiliary light; IV poles, posts, CastrGards, and mountings. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 The Datex-Ohmeda Link 25 hypoxic guard precludes setting hypoxic O2 flow ratios. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 3 Plus color LCD or CRT on the optional S/5 AM. 4 Wall mounted, pendant. 50

51 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE Aestiva 7900 Aestiva Compact Aisys Carestation Avance WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE Yes Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 4 optional (O2, N2O, air) 3 (O2, air, optional N2O) 3 (O2, air, optional N2O) GAS CYLINDER YOKES Up to 5 (O2, N2O, air, CO2, heliox) 4 optional (O2, N2O, air) 2 (O2; optional N2O, air) 2 (O2; optional N2O, air) VAPORIZERS, AGENTS Type Tec 7 temperature, flow, pressure compensated, Tec 7 temperature, flow, pressure compensated, Aladin cassette EZ Fill EZ Fill Number 2 or Interlock Yes Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Pneumatic Pneumatic Electronic Electronic HYPOXIC MIXTURE Mechanical link Mechanical link Electronic Electronic FAIL-SAFE AUTOMATIC VENTILATOR BELLOWS, SIZE 1,500 ml 1,500 ml 1,500 ml 1,500 ml Type Ascending, standing, multibreath Ascending, standing, multibreath Ascending, standing, multibreath Primary controls Ventilation modes Tec 7 temperature, flow, pressure compensated, EZ Fill Ascending, standing, multibreath VCV, PCV, SIMV-PC, PSVPro, CPAP VCV, optional PCV VCV, PCV, SIMV-VC, SIMV-PC, PSVPro, CPAP Tidal volume 1,500 ml 1,500 ml 1,500 ml 1,500 ml Range, cc 20-1, , , ,500 Minute volume Yes Yes Yes Yes Range, L/min Frequency, bpm Inspiratory flow, L/min IE ratio 2:1 to 1:8 2:1 to 1:6 2:1 to 1:8 2:1 to 1:8 Inspiratory pause 0-60% Ti 0-60% Ti 0-60% Ti 0-60% Ti VCV, PCV, SIMV-VC, SIMV-PC, PSVPro, CPAP Pressure limit, cm H2O PEEP, cm H2O 4-30 electronic 4-30 electronic 4-30 electronic 4-30 electronic Other controls Float-type flowmeters, breath-to-breath tidal volume compensation Float-type flowmeters, breath-to-breath tidal volume compensation Electronic mixer breath-tobreath tidal volume compensation compensation System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Electronic mixer breath-tobreath tidal volume Manual pre-use test, ventilator self-test Manual pre-use test, ventilator self-test Electronic, semi-automatic Electronic, semi-automatic Active, passive, or open Active, passive, or open Active, passive, or open Active, passive, or open reservoir reservoir reservoir reservoir Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity Optional using Centricity This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 51

52 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE Aestiva 7900 Aestiva Compact Aisys Carestation Avance MONITORS Airway pressure Yes Yes Yes Yes Where measured Inspiratory limb Inspiratory limb Inspiratory limb Inspiratory limb High-pressure Adjustable Adjustable Adjustable Adjustable Subatmospheric Yes Yes Yes Yes pressure Continuing pressure Yes Yes Yes Yes Low pressure/apnea Yes Yes Yes Yes Other pressure s PEEP high Not specified Not specified Not specified Expiratory volume/flow Yes Yes Yes Yes Type of sensor Differential press Differential press Differential press Differential press Where measured Expiratory port Expiratory port Expiratory port Expiratory port Rate No No No No Apnea Yes Yes Yes Yes Reverse-flow Yes Yes Yes Yes High/low minute Yes Yes Yes Yes volume High/low flow Yes Yes Yes Yes Other expiratory Circuit leak Circuit leak Circuit leak Circuit leak s O2 concentration Yes 1 Yes 1 Yes 1 Yes 1 Type of sensor Fuel cell Fuel cell Fuel cell, optional paramagnetic Fuel cell, optional paramagnetic Response time, sec <35 <35 <35/breath-to-breath <35/breath to breath CO2 concentration Optional Optional Optional Optional Apnea Yes Yes Yes Yes N2O Yes, with above Yes, with above Yes, with above Yes, with above Agent monitors Yes, with above Yes, with above Yes, with above Yes, with abobe Type of agents All 5, plus mixture All 5, plus mixture All 5, plus mixture All 5, plus mixture Auto ID Yes Yes Yes Yes Agent concentration Yes Yes Yes Yes ECG 3-, 5-, or 12-lead 3-, 5-, or 12-lead 3-, 5-, or 12-lead 3-, 5-, or 12-lead Heart rate bpm bpm bpm bpm ST segment -6 to +6-6 to +6-6 to +6-6 to +6 Noninvasive BP 15 to 260 mm Hg 15 to 260 mm Hg 15 to 260 mm Hg 15 to 260 mm Hg Invasive BP -40 to 320 mm Hg -40 to 320 mm Hg -40 to 320 mm Hg -40 to 320 mm Hg Temperature C or F, up to 4 C or F, up to 4 C or F up to 4 C or F up to 4 Pulse oximeter Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Nellcor/Datex-Ohmeda Other monitors Respiration, NMT 2 Respiration, NMT 2 Respiration, NMT 2 Respiration, NMT 2 Other features Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring Trend, printing, networking available with S/5 AM monitoring This is the second of three pages covering the above model(s). These specifications continue onto the next page. 52

53 MODEL DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE DATEX-OHMEDA/GE HEALTHCARE Aestiva 7900 Aestiva Compact Aisys Carestation Avance DISPLAYS Not specified Not specified Number One 30.5 cm (12"); optional 30.5 cm (12"), 38.1 cm (15"), 43.2 (17") One 30.5 cm (12"); optional 30.5 cm (12"), 38.1 cm (15"), 43.2 (17") Type ICE LCD monochrome 4 Full color Full color Integrated Yes Yes Yes Yes Interface with others RS232 and DIS RS232 and DIS RS232 RS232 DATA INPUT No No Not specified Not specified PRIORITIZED ALARMS 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm x 75 x x 75 x x 73.5 x x 72 x 73 Weight, kg Shelves, cm [47.5 : 67.5 : 87.5] x x x x 40 Drawers, cm 10.5 x 38.5 x 26; opt 14.5 Not specified 10.5 x 37.8 x 37.6 (2), x 33 x 26.5 (2) x 38.5 x 26 x 37.8 x 37.6 (1) Writing shelf, cm 31.5 x x x 36.3 NA Installation Mobile with locking casters Mobile with locking casters Mobile with locking casters Mobile with locking casters POWER REQUIRED, 100/120; optional 220/ /120, optional 220/ /120, optional 220/ /120, optional 220/240 VAC Auxiliary outlets 4 with individual circuit breakers 4 with individual circuit breakers 4 with individual circuit breakers 4 with individual circuit breakers BACKUP BATTERY In ventilator In ventilator Yes Yes Type Sealed lead-acid Lead acid Lead acid Lead acid Use per charge, hr 0.5 maximum load 0.5 maximum load 0.5 maximum load 0.5 maximum load PURCHASE INFORMATION Price $40,000-57,000 $32,000-35,000 $60,000-85,000 $60,000-75,000 Warranty 1 year 1 year 1 year 1 year; 3 years, vaporizer Service contract Available Available Available Available Delivery time, ARO 2-6 weeks 2-6 weeks 2-6 weeks 2-6 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes 5.5 liter volume in vent mode; vaporizer storage bracket; 2 or 3 in-line vaporizers; breathing system/bag s; auxiliary common gas outlet; number of cylinder yokes; integrated suction and auxiliary oxygen flowmeter; Bain module; auxiliary light; IV poles, posts, CastrGards, and mountings. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 The Datex-Ohmeda Link 25 hypoxic guard precludes setting hypoxic O2 flow ratios. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 3 Plus up to 3 optional screens on the S/5 AM. 5.5 liter volume in vent mode; vaporizer storage bracket; breathing system/bag s; auxiliary common gas outlet; number of cylinder yokes; Bain module; auxiliary light; IV poles, posts, CastrGards, mountings. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 The Datex-Ohmeda Link 25 hypoxic guard precludes setting hypoxic O2 flow ratios. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 3 Plus up to 3 optional screens on the S/5 AM. 4 Plus color LCD or CRT on the optional S/5 AM. 2.7 liter volume in vent mode; vaporizer storage brackets; breathing system/bag s; number of cylinder yokes and gases; auxiliary common gas outlet; oxygen flowmeter; IV poles; CastrGard; integrated suction. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 Available with Datex- Ohmeda S/5 AM anesthesia monitoring system. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 2.7 liter volume in vent mode; vaporizer storage brackets; breathing system/bag s; number of cylinder yokes and gases; auxiliary common gas outlet; oxygen flowmeter; IV poles; CastrGard; integrated suction. Meets requirements of ASTM F180, CSA, EN 740, JIS, and UL. 1 Available with Datex- Ohmeda S/5 AM anesthesia monitoring system. 2 Cardiac output, SvO2, spirometry, DIS interface to other monitors, EEG. 53

54 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Apollo Fabius CE 3-Gas Version Fabius GS Fabius Tiro WHERE MARKETED USA Worldwide, except North Worldwide Worldwide America FDA CLEARANCE Yes No Yes Yes CE MARK (MDD) No Yes Yes Yes PIPELINE GAS INLETS 3 (O2, air, N2O) 2 or 3 (O2, air, optional N2O) 3 (O2, air, N2O), 2 optional (O2, air) 3 (O2, air, N2O), 2 optional (O2, air) GAS CYLINDER YOKES 3 (O2; optional N2O, air) 2 or 4 optional (O2, N2O) 3 (2 O2; air or N2O) 2 (O2, N2O) VAPORIZERS, AGENTS Type Variable bypass, removable mount 2 or 3 removable Variable bypass, heated () Variable bypass, removable mount Number 1 or 2 2 or 3 (autoexclusion (autoexclusion system) system) Interlock Yes Yes Yes NA SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Yes Acoustic, N2O lock Yes Yes Variable bypass, removable mount 1 (removable) HYPOXIC MIXTURE Pneumatic O2 ratio O2 ratio controller O2 ratio controller O2 ratio controller FAIL-SAFE controller AUTOMATIC Yes Electronically Yes Yes VENTILATOR driven/controlled BELLOWS, SIZE Not specified Adult/pediatric Adult/pediatric Adult/pediatric Type Piston, 1,400 ml Piston unit Piston, 1,400 ml Piston, 1,400 ml Primary controls Ventilation modes Manual/spontaneous, volume, pressure; optional synchronization on volume and pressure, pressure support on volume and pressure, and pressure support mode IPPV, manual, spontaneous, pressure limited Manual/spontaneous, volume; optional pressure, pressure support, SIMV Tidal volume Yes Yes Yes Yes Range, cc 10-1, , , ,400 Minute volume Yes Yes Yes Yes Range, L/min Up to Up to 25 Up to 25 Frequency, bpm Inspiratory flow, L/min maximum IE ratio 5:1 to 1:5 1:3 to 2:1 4:1 to 1:4 4:1 to 1:4 Inspiratory pause 0-60% Ti 5-50% Ti 0-50% Ti 0-50% Ti Pressure limit, cm mbar, adjustable H2O PEEP, cm H2O variable electronic Other controls Pmax (pressure limit), slope time Tslope (pressure control), inspiratory pause (Tip:Ti), pressure support level (delta Pps) None specified Pmax (pressure limit), inspiratory flow (pressure control), inspiratory pause (Tip:Ti) System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Manual checklist, fully automated self test Pre-use system check Semi-automatic leak and compliance check, self diagnosis of processor Manual/spontaneous, volume; optional pressure, pressure support, SIMV Pmax (pressure limit), inspiratory flow (pressure control), inspiratory pause (Tip:Ti) Semi-automatic leak and compliance check, self diagnosis of processor Optional active or passive Active AGSS Optional active or passive Optional active or passive interface interface interface Optional Optional Optional Optional Optional Optional Optional Optional This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 54

55 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Apollo Fabius CE 3-Gas Version Fabius GS Fabius Tiro MONITORS Airway pressure Yes Piezoresistive Yes Yes Where measured Expiratory limb Absorber Inspiratory limb Inspiratory limb High-pressure 5-99 cm H2O 5-78 mbar 5-78 mbar 5-78 mbar Subatmospheric 7 cm H2O Yes -8 cm H2O -8 cm H2O pressure Continuing pressure Above pressure threshold for >15 seconds Yes Above pressure threshold for >15 seconds Above pressure threshold for >15 seconds Low pressure/apnea Below pressure threshold Apnea Below pressure threshold Below pressure threshold Other pressure s for >15 seconds High PEEP, apnea ventilation (in pressure support), Paw not attained Pressure limitation for >15 seconds High PEEP, apnea, low threshold for >15 seconds High PEEP, apnea, low threshold Expiratory volume/flow Yes, inspiratory data also Yes Yes Yes available Type of sensor Hot-wire flow sensor Differential press Hot-wire flow sensor Hot-wire flow sensor Where measured Expiratory and inspiratory Expiratory port Expiratory limb Expiratory port limb Rate No No No No Apnea Yes; pressure, flow, and CO2 apnea s available Yes Yes Yes Reverse-flow No (covered by integrated Yes Yes Yes patient gas monitoring) High/low minute Yes Yes Low Low volume High/low flow No No No No Other expiratory s Sensor disconnect/fail (inspiratory and Sensor inop Sensor disconnect Sensor disconnect expiratory) O2 concentration Yes Inspiratory Yes Yes Type of sensor Paramagnetic Galvanic cell Dual galvanic cell Dual galvanic cell Response time, sec <500 msec <25 <25 <25 CO2 concentration Yes Optional No No Apnea Yes Optional No No N2O Yes Optional No No Agent monitors Yes Optional No No Type of agents Not specified No No Auto ID Yes Not specified No No Agent concentration Yes Not specified No No ECG No Optional No No Heart rate No Optional No No ST segment No Optional No No Noninvasive BP No Optional No No Invasive BP No Optional No No Temperature No Optional No No Pulse oximeter Yes Optional No No Other monitors None specified None specified None specified None specified Other features Auxiliary O2 flowmeter, auxiliary Paw gauge, realtime curves for gas concentrations 1 None specified Ventilation waveform, auxiliary O2 flowmeter Ventilation waveform, auxiliary O2 flowmeter This is the second of three pages covering the above model(s). These specifications continue onto the next page. 55

56 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Apollo Fabius CE 3-Gas Version Fabius GS Fabius Tiro DISPLAYS Yes Yes Yes Yes Number Type TFT color flat panel LCD EL flat panel EL flat panel Integrated Yes Yes Yes Yes Interface with others Yes Yes Yes Yes DATA INPUT Membrane keys, rotary knob Rotary knob, softkeys, hardkeys Membrane keys, rotary knob Membrane keys, rotary knob PRIORITIZED ALARMS 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 150 x 85 x x 96 x x 89 x x 57.9 x 62.7 Weight, kg Shelves, cm 63 x x x 43; optional pull-out 30 x 36; optional side tray writing tray Drawers, cm ~44 x 28 x 14 (2) Not specified (2 or 3) 28 x 43 (3) 30 x 36 (3) Writing shelf, cm 46 x x x x 32 Installation Trolley Mobile, pendant, wall Trolley Trolley, wall POWER REQUIRED, , 50/60 Hz VAC Auxiliary outlets 2 with automatic circuit breakers at 4 A each, 1 outlet for Draeger vaporizer at 2 A, outlet for optional Draeger halogen lamp No Optional Optional BACKUP BATTERY Yes Yes Yes Yes Type Sealed lead-acid Lead gel Sealed lead-acid Sealed lead-acid Use per charge, hr > PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Yes Yes Yes Yes Delivery time, ARO 30 days 30 days 30 days 30 days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Electrically driven ventilator; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of fresh gas data to an anesthesia information system; warmed breathing system; integrated gas analyzer. 1 Inspiratory and expiratory values for all measured gases; trends for all; measured gases; curve display for Paw; numerical display for MEAN, PEAK, PLAT, PEEP; curve display for flow (inspiratory/expiratory); numerical display for MV, Vt, rate, MVleak, Cpat; trends for MV and Cpat; bar graphs for Vt and Paw; low-flow wizard; optional curve display for SpO2 (plethysmogram); optional numerical display for SpO2 and heart rate; optional trend for SpO2 and pulse; optional p/vloop and flow/v-loop. Electrically driven ventilator; fresh gas decoupled; compact breathing system; modular; wall, ceiling, and trolley mounts; access to ventilator and breathing system for sterilization; military variant with shipping cases available. Electrically driven ventilator; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of fresh gas data to an anesthesia information system; warmed breathing system. Electrically driven ventilator; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of fresh gas data to an anesthesia information system; warmed breathing system. 56

57 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Narkomed 6400 Narkomed GS Narkomed MRI-2 Primus WHERE MARKETED North America North America Worldwide, except Europe Worldwide, except USA FDA CLEARANCE Yes Yes Yes No CE MARK (MDD) No Yes No Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 2 (O2, N2O), 3 optional 3 (O2, N2O, air) 3 (O2, N2O, air) (O2, air, N2O) GAS CYLINDER YOKES 3 ([O2, N2O, air] or [CO2, O2, air]) 2 (O2, N2O), 3 (O2, N2O, air), 5 maximum optional 3 (O2, N2O, air) 2 (O2, N2O) VAPORIZERS, AGENTS Type Variable bypass, removable mount Variable bypass, removable or fixed mount halothane, isoflurane Variable bypass, removable mount Variable bypass, fixed mount 2 fixed 2 removable Number 2 or 3 (removable) 2 fixed; optional 2 removable or 3 fixed Interlock Yes Yes Yes Yes SUCTION SYSTEM Optional, piping included Optional Not specified Optional O2 FAIL-SAFE Yes Yes Yes Acoustic, N2O lock HYPOXIC MIXTURE FAIL-SAFE O2 ratio controller O2 ratio controller O2 ratio controller Electronic O2 ratio controller AUTOMATIC Yes Yes Yes Yes VENTILATOR BELLOWS, SIZE Adult/pediatric Adult/pediatric Not specified Universal Type Piston Ascending Ascending Piston, 1,400 ml Primary controls Ventilation modes Manual/spontaneous, volume, pressure support, SIMV Manual/spontaneous, volume with pressure control Manual/spontaneous, volume with pressure control Manual/spontaneous, volume, pressure; optional synchronization on volume and pressure, pressure support on volume and pressure, and pressure support mode Tidal volume Yes Yes Yes Yes Range, cc 10-1, , , ,400 Minute volume Yes Yes Yes Yes Range, L/min Up to 25 Up to 50 Up to 50 Up to 50 Frequency, bpm Inspiratory flow, L/min IE ratio 1:5 to 5:1 1:4.5 to 4:1 1:4.5 to 4:1 >1:10 to 2:1; user sets inspiratory time Inspiratory pause 0-60% Ti Adjustable Adjustable 0-60% Ti Pressure limit, cm H2O PEEP, cm H2O 0-20 Off, 2-15 No 0-20 Other controls Pmax (pressure limit), inspiratory flow (pressure control), inspiratory pause (Tip:Ti), SIMV rate System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Semi-automatic leak and compliance check, self diagnosis of processor Inspiratory flow Inspiratory flow Volume/pressure control, manual, spontaneous, SIMV, trigger, ramp time, optional pressure support Manual checklist, electronic systems test Manual checklist, electronic systems test Manual checklist, fully automated self test Optional active or passive Optional active or passive Optional active or passive Active AGSS interface interface interface Yes Optional No Optional Optional Optional No Optional This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 57

58 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Narkomed 6400 Narkomed GS Narkomed MRI-2 Primus MONITORS Airway pressure Yes Yes Yes Yes Where measured Inspiratory limb Absorber, Y-piece Absorber, Y-piece Expiratory limb High-pressure 5-80 mbar cm H2O cm H2O 5-99 cm H2O Subatmospheric -10 cm H2O 10 cm H2O 10 cm H2O <-7 cm H2O pressure Continuing pressure Low pressure/apnea Other pressure s Above pressure threshold for >15 seconds Below pressure threshold for >15 seconds High PEEP, apnea, low threshold Above pressure threshold for >15 seconds Below pressure threshold for >15 seconds High PEEP, apnea, low threshold Above pressure threshold for >15 seconds Below pressure threshold for >15 seconds Apnea, low threshold High PEEP, apnea ventilation (in pressure support), Paw not attained High PEEP, apnea ventilation (in pressure support), Paw not attained High PEEP, apnea ventilation (in pressure support), Paw not attained Expiratory volume/flow Yes Yes Yes Yes, inspiratory data also available Type of sensor Ultrasonic flow sensor Ultrasonic flow sensor Ultrasonic flow sensor Hot-wire flow sensor Where measured Expiratory limb Expiratory limb Expiratory limb Expiratory and inspiratory limb Rate No Yes Yes No Apnea Yes Yes Yes Yes; pressure, flow, and CO2 apnea s available Reverse-flow Yes Yes Yes No (covered by integrated patient gas monitoring) High/low minute Low Low Low Yes volume High/low flow No No No No Other expiratory s Sensor disconnect Sensor disconnect Sensor disconnect Sensor disconnect/fail (inspiratory and expiratory) O2 concentration Yes Yes Yes Inspiration/expiration Type of sensor Dual galvanic cell Dual galvanic cell Dual galvanic cell Galvanic cell, optional paramagnetic Response time, sec <25 <25 <25 <0.5 CO2 concentration Yes No No Yes Apnea Yes No No Yes N2O Yes No No Yes Agent monitors Yes No No Yes Type of agents No No Auto ID Yes No No Yes Agent concentration Yes No No Yes ECG Optional No No No Heart rate Yes No No No ST segment Yes No No No Noninvasive BP Optional No No No Invasive BP Optional No No No Temperature Optional No No No Pulse oximeter Optional No No No Other monitors CO None None CO, optional 2 temperatures Other features Lung compliance trend, datalog, PA wedge calculation Ventilation waveform, auxiliary O2 flowmeter Ventilation waveform, auxiliary O2 flowmeter Auxiliary O2 flowmeter, auxiliary Paw gauge, realtime curves for gas concentrations 1 This is the second of three pages covering the above model(s). These specifications continue onto the next page. 58

59 MODEL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL DRAEGER MEDICAL Narkomed 6400 Narkomed GS Narkomed MRI-2 Primus DISPLAYS Yes Yes Yes Yes Number Type Flat panel color EL flat panel EL flat panel TFT color flat panel touchscreen (38.1 cm [15"]) Integrated Yes Yes Yes Yes Interface with others Yes Yes Yes Yes DATA INPUT Rotary knob, touchscreen, hardkeys Membrane keys Membrane keys Membrane keys, rotary knob PRIORITIZED ALARMS 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 86 x 145 x x 91 x x 80 x x 80 x 80 Weight, kg Shelves, cm 56 x x 35 NA Not specified Drawers, cm 56 x x 35.5 x 10 (3) NA Not specified (1) Writing shelf, cm 41 x x x 20.3 Not specified Installation Trolley Trolley Trolley Mobile, ceiling, wall POWER REQUIRED, VAC Auxiliary outlets BACKUP BATTERY Yes Yes Yes Yes Type Sealed lead-acid Sealed lead-acid Sealed lead-acid Lead gel Use per charge, hr >0.5 >0.5 >0.5 >0.5 PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Yes Yes Yes Yes Delivery time, ARO 30 days 30 days 30 days 30 days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Electrically driven ventilator; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of fresh gas data to an anesthesia information system; warmed breathing system; optional integrated patient monitoring system. None specified. No distance limitations from magnet; up to 3 Tesla. Electrically driven ventilator; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of fresh gas data to an anesthesia information system; warmed breathing system; integrated gas analyzer. 1 Inspiratory and expiratory values for all measured gases; trends for all; measured gases; curve display for Paw; numerical display for MEAN, PEAK, PLAT, PEEP; curve display for flow (inspiratory/expiratory); numerical 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/vloop and flow/v-loop. 59

60 MODEL DRAEGER MEDICAL EKU ELEKTRONIK EKU ELEKTRONIK EKU ELEKTRONIK Zeus ARCUS AREA-CT AREA-CT4 WHERE MARKETED Worldwide, except USA Worldwide, except North America Worldwide, except North America Worldwide, except North America FDA CLEARANCE No No No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) with electronic manometer 3, with electronic gas failure 100% 3, with electronic gas failure 100% GAS CYLINDER YOKES 2 (O2, N2O) 3 Optional Optional VAPORIZERS, AGENTS Sevoflurane, isoflurane, Type Direct injection system Variable bypass Variable bypass Variable bypass Number 2 removable 1 1 or 2 1 or 2 Interlock Electronic Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Yes Electronic O2 deficiency detection Electronic O2 deficiency detection Electronic O2 deficiency detection HYPOXIC MIXTURE Electronic O2 ratio Electronic ratio system, Electronic ratio system Electronic ratio system FAIL-SAFE controller O2 concentration >25% AUTOMATIC Yes Optional MAV3 Yes Yes VENTILATOR BELLOWS, SIZE Universal Not specified Adult/pediatric Adult/pediatric Type Bag reservoir, 3,000 ml Not specified Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes Manual/spontaneous, volume mode autoflow with or without synchronization, pressure mode with or without synchronization; CPAP/pressure support Manual Manual, volume/pressure controlled CMV, PCV, manual/spontaneous, SIMV, MMV, ASB Tidal volume Yes Not specified Yes Yes Range, cc 20-1,500 Not specified ,600 (5-350 neonatal mode) Minute volume Yes Not specified Yes Yes Range, L/min Up to 40 Not specified Frequency, bpm 3-80 Not specified ( neonatal mode) Inspiratory flow, L/min 180 maximum Not specified ,600 ml IE ratio 4:1 to 1:4 Not specified 1:0.5 to 1:4 2:1 to 1:4 Inspiratory pause 20-50% Ti Not specified 5-50% 0-60% Ti Pressure limit, cm 5-70 Not specified 10-80, adjustable (PEEP + 5) to 80 hpa H2O PEEP, cm H2O 3-35 Not specified 0-16 variable, electronic 0-20 hpa (integrated) Other controls Slope time, inspiratory time, trigger, pressure support level Not specified Electronic flow, EVC, adult/pediatric modes, auto dose of fresh gas flow Electronic flow, EVC, pediatric and adult modes, auto dose of fresh gas flow, special neonatal mode, gas monitoring integrated in ventilator System checks Fully automated self diagnostics with graphical help Not specified Self-test/control of components, circuit compliance/leakage Self-test/control of components, circuit compliance/leakage SCAVENGING SYSTEM Optional active AGSS Exhaust AGSS; optional active AGSS; optional active AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Optional No No No Optional No No No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 60

61 MODEL DRAEGER MEDICAL EKU ELEKTRONIK EKU ELEKTRONIK EKU ELEKTRONIK Zeus ARCUS AREA-CT AREA-CT4 MONITORS Airway pressure Yes Optional MM1 Peak, plateau Peak, plateau Where measured Expiratory and inspiratory Gas inlet Gas inlet Gas inlet limb High-pressure 5-80 cm H2O Optional MM cm H2O cm H2O Subatmospheric 10 cm H2O Not specified No No pressure Continuing pressure High PEEP Optional MM1 Yes Yes Low pressure/apnea Yes Not specified Yes Yes Other pressure s High PEEP Optional MM1 Peak, PEEP Peak, PEEP Expiratory volume/flow Yes Not specified Yes Yes Type of sensor Hot-wire flow sensor Hot wire Hot wire Hot wire Where measured Expiratory and inspiratory Circuit, gas outlet Circuit, gas outlet Circuit, gas outlet limb, Y-piece Rate No No No Yes Apnea Yes After 12 sec After 12 sec After 12 sec Reverse-flow Yes No No Yes High/low minute Yes Yes Yes Yes volume High/low flow No Yes Yes Yes Other expiratory Sensor disconnect/fail, air Disconnection, unit alerts Disconnection, unit alerts Disconnection, unit alerts s trapping, tube leak O2 concentration Inspiration/expiration Optional MM1 Yes Yes (integrated in ventilator) Type of sensor Paramagnetic Galvanic cell Galvanic cell Galvanic cell (optional paramagnetic) Response time, sec <0.5 ~12 ~12 ~12 CO2 concentration Yes Optional MM1 Yes Yes (integrated in ventilator) Apnea Yes Optional MM1 After 12 sec Yes N2O Yes Optional MM1 Yes Yes (integrated in ventilator) Agent monitors Yes Optional MM1 Yes Yes (integrated in ventilator) Type of agents Optional MM1 (sevoflurane, enflurane, ) Auto ID Yes Optional MM1 Optional Optional Agent concentration Yes Optional MM1 Yes Yes ECG Yes Optional MM1 Yes Optional Heart rate Yes Optional MM1 Yes Optional ST segment Yes No Yes Optional Noninvasive BP Yes Optional MM1 Yes Optional Invasive BP Yes No No No Temperature Yes No No No Pulse oximeter Yes Optional MM1 Yes Optional Other monitors EEG (BIS), NMT Available Respiration Volume, pressure, O2, CO2, anaesthetic agents, MAC value Other features PV loop, information with cause and remedy, minitrends, programmable soft keys, user-defined setups None specified None specified Monitoring is integrated in ventilator This is the second of three pages covering the above model(s). These specifications continue onto the next page. 61

62 MODEL DRAEGER MEDICAL EKU ELEKTRONIK EKU ELEKTRONIK EKU ELEKTRONIK Zeus ARCUS AREA-CT AREA-CT4 DISPLAYS Yes Yes Yes Yes Number Type 15" TFT color flat panel touchscreen LCD, illuminated LCD LCD, color TFT-LCD touchscreen (16.3 cm [6.4"]) for ventilator Integrated Yes Yes Yes Yes Interface with others Serial, 2 X network Yes Yes Yes DATA INPUT Hard keys, rotary knob, touchscreen ComWheel, membrane switches ComWheel, membrane switches ComWheel, membrane switches PRIORITIZED ALARMS 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 70 x 165 x x 55.9 x x 65 x x 48 x 55 Weight, kg Shelves, cm 60 x 60 NA 42 x x 43 Drawers, cm 53 x 30 NA 45 x 46 x 18 (optional) 45 x 46 x 18 (optional) Writing shelf, cm 35 x 30 x 10 NA 41 x 43 (optional) 41 x 43 (optional) Installation Mobile, ceiling Mobile (portable) Mobile (trolley) Mobile (trolley) POWER REQUIRED, / / /230 VAC Auxiliary outlets BACKUP BATTERY Yes Yes Yes Yes Type Lead-acid gel Rechargeable Rechargeable Rechargeable Use per charge, hr > PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 1 year 2 years 2 years 2 years Service contract Yes Optional Optional Optional Delivery time, ARO 30 days 3-4 weeks 3-4 weeks 3-4 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Electrically driven turbine ventilator with circle flow; fresh gas decoupled; compliance compensated; compact breathing system; electronic export of all gas delivering 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. 1 Inspiratory and expiratory values for all measured gases; trends for all; measured gases; curve display for Paw; numerical display for MEAN, PEAK, PLAT, PEEP; curve display for flow (inspiratory/expiratory); numerical 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 loops (p/v-loop and flow/vloop). Portable; built-in flight cases; optional standalone ventilator and monitoring (also available in flight cases). Electronic gas mixer; small circuit system for low anesthesia; leakage test; electronic supervision of pressure supply with display and function. Electronic gas mixer; small circuit system for low anesthesia; also leakage test; electronic supervision of pressure supply with display and function; electronic anesthesia record can be attached to this system; other manufacturer's monitors can be used with this system. 62

63 MODEL EKU ELEKTRONIK EKU ELEKTRONIK F STEPHAN F STEPHAN TANGENS 2C TANGENS M AKZENT ARTEC : PORTEC WHERE MARKETED Worldwide, except North Worldwide, except North Worldwide, except USA Worldwide, except USA America America FDA CLEARANCE No No Not specified Not specified CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3, with electronic gas 3, with electronic gas 5 (2 O2, 2 N2O, air) 3 (O2, N2O, air) failure 100% failure 100% GAS CYLINDER YOKES optional (O2, N2O) 2 optional (O2, N2O) : 2 (O2, N2O) VAPORIZERS, AGENTS isoflurane, halothane, isoflurane, halothane, 1 Type Variable bypass Variable bypass Variable bypass, temperature compensated Number : 1 Interlock Yes Yes Yes Yes SUCTION SYSTEM Optional Yes Yes Yes : Optional O2 FAIL-SAFE Variable bypass, temperature compensated Electronic O2 deficiency detection Electronic O2 deficiency detection Audible with N2O cutoff Audible with N2O cutoff Electronic ratio system Electronic ratio system, Ratio system, minimum Ratio system, minimum O2 concentration >25% 25% O2 25% O2 Yes Yes Yes Yes HYPOXIC MIXTURE FAIL-SAFE AUTOMATIC VENTILATOR BELLOWS, SIZE Adult/pediatric Adult/pediatric All Adult, optional pediatric Type Ascending, bag in bottle Ascending, bag in bottle Bellows in bottle Bellows in bottle Primary controls Ventilation modes CMV, PCV, manual/spontaneous, SIMV, MMV, ASB Manual, volume/pressure controlled VCV, PCV, SIMV CMV, SCMV, PVC, IMV, SPVC, IPPV, CPAP Tidal volume Yes Yes Yes 1 Yes Range, cc 20-1,600 (5-350 neonatal 40-1, ,500 (10-70 optional) 0-1,500; pediatric mode) Minute volume Yes Yes Yes Yes Range, L/min Frequency, bpm ( neonatal mode) Inspiratory flow, L/min 20-1,600 ml maximum IE ratio 2:1 to 1:4 1:0.5 to 1:4 1:0.2 to 1:5 in steps of 0.1 1:4 to 2:1 Inspiratory pause 0-60% Ti 5-50% No No Pressure limit, cm (PEEP + 5) to 80 hpa 10-80, adjustable 70 mbar, spontaneous 70 mbar, spontaneous H2O PEEP, cm H2O 0-20 hpa (integrated) 0-16 variable, electronic mbar variable Other controls Electronic flow, EVC, pediatric and adult modes, auto dose of fresh gas flow, special neonatal mode, complete monitoring integrated in one screen Electronic flow, EVC, adult/pediatric modes, self-test/control of components 1 Float-type flowmeter Float-type flowmeter System checks Self-test/control of components, circuit compliance/leakage Circuit compliance 2 Electronic self diagnosis including leak test SCAVENGING SYSTEM AGSS; optional active Vacuum/exhaust; optional Yes Yes active AUTO RECORD Yes No No No KEEPER ANESTHESIA DATA MANAGEMENT Yes No No No Electronic system check of ventilator This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 63

64 MODEL EKU ELEKTRONIK EKU ELEKTRONIK F STEPHAN F STEPHAN TANGENS 2C TANGENS M AKZENT ARTEC : PORTEC MONITORS Airway pressure Peak, plateau Peak, plateau Yes Yes Where measured Gas inlet Gas inlet Inspiratory/expiratory limb Expiratory limb, gas inlet High-pressure cm H2O cm H2O Yes Yes Subatmospheric No No No No pressure Continuing pressure Yes Yes Yes Yes Low pressure/apnea Yes Yes Yes Yes Other pressure s Peak, PEEP Peak, PEEP PEEP, Pmean None Expiratory volume/flow Yes Yes Yes Yes Type of sensor Hot wire Hot wire Pneumotachograph Heated wire anemometer Where measured Circuit, gas outlet Expiratory valve Inspiratory/expiratory limb Expiratory Rate Yes No No Yes Apnea After 12 sec After 12 sec Yes Yes Reverse-flow Yes No No No High/low minute Yes Yes Yes Yes volume High/low flow Yes Yes Yes Yes Other expiratory Disconnection, unit alerts Disconnection, unit alerts No No s O2 concentration Yes Yes Yes Yes Type of sensor Galvanic cell (optional Galvanic cell Paramagnetic or Electrochemical paramagnetic) electrochemical Response time, sec ~12 ~12 Not specified ~1 CO2 concentration Yes Yes Optional External optional Apnea Yes After 12 seconds Yes Yes N2O Yes Yes Optional External optional Agent monitors Yes Yes Optional External optional Type of agents halothane,, isoflurane halothane,, isoflurane Auto ID Optional Optional Optional No Agent concentration Yes Yes Yes Yes ECG Yes Yes External optional External optional Heart rate Yes Yes External optional External optional ST segment Yes Yes No No Noninvasive BP Yes Yes External optional External optional Invasive BP Yes No External optional External optional Temperature Yes No External optional External optional Pulse oximeter Yes Yes External optional External optional Other monitors MAC value Respiration None specified Respiratory function (external) Other features Electronic gas mixer, ventilator and monitoring all integrated in one screen None specified Leakage compensation in VCV, compliance compensated None specified This is the second of three pages covering the above model(s). These specifications continue onto the next page. 64

65 MODEL EKU ELEKTRONIK EKU ELEKTRONIK F STEPHAN F STEPHAN TANGENS 2C TANGENS M AKZENT ARTEC : PORTEC DISPLAYS Yes Yes Yes Yes Number Type Color TFT-display screen LCD with backlight, LED EL (15.2 cm [6"]) LED touchscreen (38.1 cm [15"]) Integrated Yes Yes Yes Yes Interface with others Yes To panel PC (38.1 cm RS232 No [15"]) DATA INPUT Touch-screen or ComWheel, membrane Turn/push button Knobs ComWheel, membrane switches PRIORITIZED ALARMS 8 8 Yes No PHYSICAL FEATURES H x W x D, cm 160 x 56 x x 65 x (140 with trolley) x 74 x x 60 x 75 : 121 x 50 x 55 Weight, kg : Not specified Shelves, cm 42 x x 43 Optional 52 x 30 (1) : 48 x 35 (1) Drawers, cm 45 x 46 x x 46 x 18 Optional 20 x 38 x x 50 (3) : 41 x 40 (3) Writing shelf, cm 41 x x 31 Optional 47 x x 32 (1) : No Installation Mobile (trolley, wall, Mobile (trolley, wall, Mobile on trolley, wall Mobile, wall mounted ceiling) ceiling) mounted 115/ / POWER REQUIRED, VAC Auxiliary outlets : No BACKUP BATTERY Yes Yes Yes Optional Type Rechargeable Rechargeable Sealed lead-acid Sealed lead-acid Use per charge, hr min PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 2 years 2 years 2 years 2 years Service contract Optional Optional Offer on request Offer on request Delivery time, ARO 3-4 weeks 3-4 weeks Not specified 30 days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes 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; system; only three levels in user interface (main screen, setting s, menu); electronic anesthesia record can be attached to this system; interface with other monitors available; TIVA syringe pumps can be connected; TIVA- Values can be displayed at the central screen. 1 Also electronic gas mixer for automatic dosage, fresh gas flow, O2 concentration, automatic altitude correction. 2 Also leakage test, electronic supervision of pressure supply with display and function. Optional display with 38.1 cm (15") monitor. 1 Also electronic gas mixer for automatic dosage, fresh gas flow, O2 concentration, automatic altitude correction. 2 Also leakage test, electronic supervision of pressure supply with display and function. None specified. 1 Fresh gas compensated. 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. 1 Desflurane is an optional agent for use with the PORTEC. 65

66 MODEL HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN Leon Plus Sinus Sinus TR Tizian M WHERE MARKETED Worldwide, except North America Worldwide, except North America Worldwide, except North America Worldwide, except North America FDA CLEARANCE No No No No CE MARK (MDD) Submitted Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 2 (O2, N2O), optional 3 3 (O2, N2O, air) (O2, N2O, air) GAS CYLINDER YOKES 2 (O2, N2O) No No 2 (O2, N2O); 4 optional VAPORIZERS, AGENTS Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Isoflurane, halothane, enflurane,, sevoflurane Type Variable bypass, fully compensated Variable bypass, fully compensated Variable bypass, fully compensated Number Interlock Yes NA NA Yes SUCTION SYSTEM Yes Optional Optional Optional O2 FAIL-SAFE Variable bypass, fully compensated Visual and audible with N2O shutoff Audible with N2O shutoff Audible with N2O shutoff Audible with N2O shutoff Electronic ratio system = Ratio system = 25% O2 in Ratio system, 25% O2 in Ratio system, 25% O2 in 25% O2 in fresh gas fresh gas fresh gas fresh gas Yes Yes No Yes HYPOXIC MIXTURE FAIL-SAFE AUTOMATIC VENTILATOR BELLOWS, SIZE Adult/pediatric Adult/pediatric None Adult/pediatric Type Descending, bag in bottle Ascending, bag in bottle NA Ascending, bag in bottle Primary controls Ventilation modes Manual/spontaneous, IMV, PCV, SIMV, S-PCV, PSV (assist) Manual/spontaneous, IMV, PCV NA Manual/spontaneous, IMV, PCV Tidal volume Yes Yes NA Yes Range, cc 20-1, ,600 NA 40-1,600 Minute volume No No NA Yes Range, L/min NA 1-25 Frequency, bpm NA 6-60 Inspiratory flow, L/min 120 maximum 80 maximum NA 80 maximum IE ratio 4:1 to 1:4 2:1 to 1:4 NA 2:1 to 1:4 Inspiratory pause 0-80% Ti 0-50% Ti NA 0-50% Ti Pressure limit, cm mbar mbar NA mbar H2O PEEP, cm H2O Off, 4-20 Off, optional 4-16 NA Off, optional 4-16 Other controls Adjustable pressure limitation NA Adjustable pressure limitation, EVC System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT Leak, self-verification tests, tightness, compliance Passive AGSS; optional active Adjustable pressure limitation, EVC (function for fresh gas compensation) Leak, self-verification tests NA Leak, self-verification tests Passive AGSS; optional Passive AGSS; optional Passive AGSS; optional active active active Logfile External optional External optional External optional External optional External optional External optional External optional This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 66

67 MODEL HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN Leon Plus Sinus Sinus TR Tizian M MONITORS Airway pressure Yes Yes Yes Yes Where measured Inspiratory patient port Inspiratory patient port Inspiratory patient port Inspiratory patient port High-pressure cm H2O cm H2O No cm H2O Subatmospheric Yes No No No pressure Continuing pressure Yes 1-60 cm H2O No 1-60 cm H2O Low pressure/apnea Yes Yes External optional Yes Other pressure s Not specified Not specified Not specified Not specified Expiratory volume/flow Flow, volume Volume Volume Volume Type of sensor Hot wire Hot wire, optional mechanical Mechanical, optional hot wire Hot wire, optional mechanical Where measured Inspiratory, expiratory flow Expiratory valve Expiratory valve Expiratory valve sensor Rate No External optional External optional External optional Apnea Yes Yes External optional Yes Reverse-flow No No No No High/low minute Yes No Not specified Yes volume High/low flow No Yes Not specified Yes Other expiratory Vte No No No s O2 concentration Yes External optional External optional Optional Type of sensor Fuel cell or paramagnetic Fuel cell or paramagnetic Fuel cell or paramagnetic Fuel cell Response time, sec CO2 concentration Yes External optional External optional External optional Apnea Yes External optional External optional External optional N2O Yes External optional External optional External optional Agent monitors Yes External optional External optional Optional Type of agents All 5 gases All 5 gases All 5 gases All 5 gases Auto ID Yes No No No Agent concentration Yes External optional External optional Optional ECG External optional External optional External optional External optional Heart rate External optional External optional External optional External optional ST segment External optional External optional External optional External optional Noninvasive BP External optional External optional External optional External optional Invasive BP External optional External optional External optional External optional Temperature External optional External optional External optional External optional Pulse oximeter External optional External optional External optional External optional Other monitors 4 real-time graphics None None None Other features Loops, MAC, compliance, resistance None None None This is the second of three pages covering the above model(s). These specifications continue onto the next page. 67

68 MODEL HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN HEINEN + LOEWENSTEIN Leon Plus Sinus Sinus TR Tizian M DISPLAYS Yes Yes No Yes Number 1 8 NA 11 (with options, 17) Type TFT touchscreen 38.1 cm LED NA LED (15") Integrated Yes Yes NA Yes Interface with others 2 RS232, 1 ETH External optional NA External optional DATA INPUT Touchscreen, encoder Push button, wheel, knobs NA Push button, wheel, knobs wheel, touchpanel PRIORITIZED ALARMS Yes Not specified No Yes PHYSICAL FEATURES H x W x D, cm 139 x 85 x x 62 x x 31 x x 57 x 61 Weight, kg Shelves, cm 60 x x 40 Optional 27 x 61 Drawers, cm 25 x 24 x 8 (3) 13 x 45 x 36 Optional 57 x 60 (3) Writing shelf, cm 25 x x 39 No 42 x 57 Installation Mobile, wall Mobile (standard), wall Wall (standard), mobile, Mobile pendant POWER REQUIRED, No VAC Auxiliary outlets 4 Optional No Optional BACKUP BATTERY Yes Yes No Yes Type Lead gel Lead gel NA Lead gel Use per charge, hr NA 0.25 PURCHASE INFORMATION Price Not specified Not specified $5,000-15,500 $8,000-25,000 Warranty 1 year 1 year 1 year 1 year Service contract Optional Optional Optional Optional Delivery time, ARO 30 days 30 days 30 days 30 days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Alternative gas supply per end-user requirements; air/n2o selection valve; low flow-ratio system; alternative integrated monitor configuration per end-user requirements. Alternative gas supply per end-user requirements; air/n2o selection valve; low flow-ratio system. Alternative gas supply per end-user requirements; air/n2o selection valve; low flow-ratio system. Alternative gas supply per end-user requirements; air/n2o selection valve; low flow-ratio system; alternative integrated monitor configuration per end-user requirements. 68

69 MODEL HEYER MEDICAL HEYER MEDICAL INTERMED INTERMED MODULAR + NARKOMAT + Inter Linea A Inter Linea C WHERE MARKETED Worldwide, except USA Worldwide, except USA Worldwide Worldwide FDA CLEARANCE No No No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES 2 optional (O2, N2O) 2 optional (O2, N2O) 2 (O2, N2O) 1 (O2) VAPORIZERS, AGENTS Isoflurane, halothane, enflurane, servoflurane Type Variable bypass Variable bypass Calibrated (temperature, flow, pressure) Number Interlock Yes Yes Yes NA SUCTION SYSTEM Optional Optional No No O2 FAIL-SAFE Acoustic with N2O shutoff Acoustic with N2O shutoff Yes Yes Isoflurane, halothane, enflurane, servoflurane Calibrated (temperature, flow, pressure) HYPOXIC MIXTURE Ratio system, >25% O2 Ratio system, >25% O2 Yes Yes FAIL-SAFE AUTOMATIC Yes Yes Yes Yes VENTILATOR BELLOWS, SIZE 1 for all patients 1 for all patients Adult/pediatric/neonate Adult/pediatric Type Descending, bag in bottle Descending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes Manual/spontaneous, CMV, PCV Manual, spontaneous, CMV, PCV, S-CMV VCV-SIMV, PCV-SIMV, spontaneous Tidal volume Yes Yes Yes Yes Range, cc 20-1, , , ,500 Minute volume Yes Yes Yes, indirect Yes, indirect Range, L/min NA NA Frequency, bpm Inspiratory flow, L/min VCV-SIMV, PCV-SIMV, spontaneous IE ratio 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:0.3 to 1:99 1:0.3 to 1:99 1:4, 1:5, 2:1, 3:1 1:4, 1:5, 2:1, 3:1 Inspiratory pause Yes Yes Yes Yes Pressure limit, cm 12-80, adjustable 12-80, adjustable 5-80, adjustable 5-80, adjustable H2O PEEP, cm H2O electronic 0-50 electronic Other controls Plateau (end inspiratory), 20% or 30% of inspiratory, volume- constant ventilation, O2 flush Plateau (end inspiration), 20% or 30% of inspiratory, expiratory pause 30 sec maximum, volumeconstant ventilation, O2 Pressure support, sigh, manual cycle, inspiratory hold, standby, 100% oxygen flush Pressure support, sigh, manual cycle, inspiratory hold, standby, 100% oxygen flush flush System checks Automatic at startup Automatic at startup None specified None specified SCAVENGING SYSTEM Optional Optional Active or passive Yes AUTO RECORD External optional External optional Up to 24 hours optional Up to 24 hours optional KEEPER ANESTHESIA DATA External optional External optional Not specified Not specified MANAGEMENT This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 69

70 MODEL HEYER MEDICAL HEYER MEDICAL INTERMED INTERMED MODULAR + NARKOMAT + Inter Linea A Inter Linea C MONITORS Airway pressure Yes Yes Yes Yes Where measured Inspiratory side Inspiratory side Inspiratory branch Inspiratory branch High-pressure Yes Yes Yes Yes Subatmospheric Yes (pressure-relief valve Yes (pressure-relief valve Not specified Not specified pressure included) included) Continuing pressure Yes Yes Yes Yes Low pressure/apnea Yes Yes Yes Yes Other pressure s Yes Yes High PEEP High PEEP Expiratory volume/flow Yes Yes Yes Yes Type of sensor Hot wire Hot wire Pneumotachograph Pneumotachograph Where measured Expiratory valve Expiratory valve Y-piece Y-piece Rate Yes Yes No No Apnea Yes Yes Yes Yes Reverse-flow No No No No High/low minute Low minute volume Low minute volume Low Low volume High/low flow No No No No Other expiratory Yes Yes Not specified Not specified s O2 concentration Yes Yes Yes Yes Type of sensor Galvanic cell Paramagnetic Galvanic cell Galvanic cell Response time, sec Not specified Not specified <25 <25 CO2 concentration External optional Yes Optional Optional Apnea Yes Yes Yes Yes N2O External optional Yes Optional Optional Agent monitors External optional Yes Optional Optional Type of agents Isoflurane, halothane, enflurane, servoflurane Auto ID No Yes Yes Optional Agent concentration External optional Yes Optional Optional ECG External optional External optional No No Heart rate External optional External optional No No ST segment External optional External optional No No Noninvasive BP External optional External optional No No Invasive BP External optional External optional No No Temperature External optional External optional No No Pulse oximeter External optional External optional No No Other monitors None specified None specified Airway resistance, respiratory system compliance Other features None None specified Trends, computer interface Isoflurane, halothane, enflurane, servoflurane Airway resistance, respiratory system compliance Trends, computer interface This is the second of three pages covering the above model(s). These specifications continue onto the next page. 70

71 MODEL HEYER MEDICAL HEYER MEDICAL INTERMED INTERMED MODULAR + NARKOMAT + Inter Linea A Inter Linea C DISPLAYS Yes Yes Optional Optional Number Type Color LCD, EL Color TFT Mono; color STN/TFT Mono; color STN/TFT Integrated Yes Yes Yes Yes Interface with others Not specified Not specified Not specified Not specified DATA INPUT Touchscreen Rotary knob, hotkeys Membrane switches, ComWheel Membrane switches, ComWheel PRIORITIZED ALARMS 3 (caution, advisory, warning) 3 (caution, advisory, warning) 3 (caution, advisory, warning) 3 (caution, advisory, warning) PHYSICAL FEATURES H x W x D, cm 153 x 69 x x 91.5 x x 70 x x 52.5 x 60 Weight, kg ~ Shelves, cm Not specified Not specified 50 x x 25 Drawers, cm Not specified (2) Not specified (2) 14 x 35 x 35 (2) 11 x 35 x 35 (2) Writing shelf, cm Yes Yes 35 x x 32 Installation Mobile, wall mount Mobile Mobile Mobile POWER REQUIRED, 120, 60 Hz; 230, 50 Hz 120/230, 50/60 Hz VAC Auxiliary outlets O2 Optional No No BACKUP BATTERY Yes Yes Yes Yes Type Lead gel Lead gel Rechargeable Rechargeable Use per charge, hr Up to 2 Up to 2 PURCHASE INFORMATION Price Not specified Not specified 17,000 (US$20,000) with monitor Warranty 2 years 2 years 2 years 2 years Service contract Not specified Not specified Yes Yes Delivery time, ARO 6 weeks 6 weeks 1 month 1 month OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Patient circuit: integrated compact bloc-heating device to avoid condensation; 65 pivoting; low- and minimal-flow ability; automatic compensation for patient system compliance; fresh-gas decoupling; automatic Vt constant. 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. Illuminated flowmeter. 14,000 (US$17,500) with monitor Illuminated flowmeter. 71

72 MODEL KIMURA MEDEC MEDEC NORMECA Siesta-21ps Neptune Saturn Evo MP-1 : MP-2 WHERE MARKETED Worldwide, except USA Worldwide, except USA Worldwide, except USA Worldwide, except North America FDA CLEARANCE No No No No CE MARK (MDD) No Yes Yes No PIPELINE GAS INLETS 2 (O2, N2O) 3 (O2, N2O, air) 3 (O2, N2O, air) Draw-over : 2 (O2, N2O) GAS CYLINDER YOKES 2 (O2, N2O) 2 optional (O2, N2O) 2 optional (O2, N2O) No VAPORIZERS, AGENTS Halothane, isoflurane, enflurane, sevoflurane Halothane, enflurane, trilene, isoflurane Type Cap screw or key filler Not specified Not specified Variable bypass Number Interlock No Yes Yes No SUCTION SYSTEM Not specified Yes Yes No O2 FAIL-SAFE Yes Electronic and pneumatic Electronic and pneumatic No system system HYPOXIC MIXTURE Minimum 30% O2 Yes Yes No FAIL-SAFE AUTOMATIC Yes; optional not built-in Yes Yes No VENTILATOR BELLOWS, SIZE Not specified One for neonate to adult One for neonate to adult NA Type Electrically driven Horizontal bag in bottle Horizontal bag in bottle NA Primary controls Ventilation modes CMV, assisted CMV CMV, manual, CMV, manual, NA spontaneous, PCV spontaneous, PCV Tidal volume Yes Yes Yes NA Range, cc ml 10-1,600 ml 10-1,600 ml NA Minute volume Not specified Yes Yes NA Range, L/min Not specified Not specified Not specified NA Frequency, bpm NA Inspiratory flow, L/min Not specified Automatic Automatic NA IE ratio 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:1, 1:1.5, 1:2, 1:3, 1:4, NA 1:5 1:5, 1:6, 2:1, 3:1, 4:1 1:5, 1:6, 2:1, 3:1, 4:1 Inspiratory pause 5% inspiratory time 0-50% 0-50% NA Pressure limit, cm 70, safety relief 7-99 mbar, adjustable 7-99 mbar, adjustable NA H2O PEEP, cm H2O NA 0-20 cm H2O adjustable, 0-20 cm H2O adjustable, NA electronic PEEP Other controls None specified Auto self-test, full test/maintenance programs System checks SCAVENGING SYSTEM AUTO RECORD KEEPER ANESTHESIA DATA MANAGEMENT electronic PEEP Auto self-test, full test/maintenance programs Overload, over range preset, CPU observation Leaks, resistance, compliance Leaks, resistance, compliance NA Optional vacuum or Vacuum or active Vacuum or active No exhaust No Optional Optional No Not specified Optional Optional No NA This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 72

73 MODEL KIMURA MEDEC MEDEC NORMECA Siesta-21ps Neptune Saturn Evo MP-1 : MP-2 MONITORS Airway pressure Yes Yes Yes No Where measured Circuit Patient circuit Patient circuit NA High-pressure Yes 7-99 cm H2O 7-99 cm H2O NA Subatmospheric No Not specified Not specified NA pressure Continuing pressure No Yes Yes NA Low pressure/apnea No Yes Yes NA Other pressure s Low pressure, electric Not specified Not specified NA failure Expiratory volume/flow No Yes Yes No Type of sensor NA Electronic Electronic NA Where measured NA Circuit Circuit NA Rate NA Yes Yes NA Apnea NA Yes Yes NA Reverse-flow NA Yes Yes NA High/low minute NA Yes Yes NA volume High/low flow NA Yes Yes NA Other expiratory NA Leakage Leakage NA s O2 concentration Yes Yes Yes No Type of sensor Galvanic cell Galvanic cell Galvanic cell NA Response time, sec 12 (90%) Optional Optional NA CO2 concentration 0-100% range Optional Optional No Apnea No Yes Yes NA N2O No Optional Optional No Agent monitors No Optional Optional No Type of agents NA Optional Optional NA Auto ID NA Optional Optional NA Agent concentration NA Optional Optional NA ECG No Optional Optional No Heart rate NA Optional Optional NA ST segment NA Optional Optional NA Noninvasive BP No Optional Optional No Invasive BP No Optional Optional No Temperature No Optional Optional No Pulse oximeter No Optional Optional No Other monitors None specified Optional Optional None Other features Optional infant circle absorber None specified None specified None specified This is the second of three pages covering the above model(s). These specifications continue onto the next page. 73

74 MODEL KIMURA MEDEC MEDEC NORMECA Siesta-21ps Neptune Saturn Evo MP-1 : MP-2 DISPLAYS Yes Yes Yes No Number Not specified 1 1 NA Type Proximal airway pressure QVGA Color touchscreen NA monitor (analog); O2 concentration, tidal volume, breath rate (digital) Integrated Not specified Yes Yes NA Interface with others Not specified No No NA DATA INPUT No Knobs, keyboard Knobs, keyboard, No touchscreen PRIORITIZED ALARMS No Yes Yes No PHYSICAL FEATURES H x W x D, cm 131 x 54 x x 60 x x 65 x x 35.5 x 24.5 Weight, kg : 10.8 Shelves, cm 47 x 37 tabletop, 53 x 30 Not specified (1) Not specified (1) None : 19 x 36 (1) monitor Drawers, cm 15 x 44 x 35 Not specified (3) Not specified (3) None Writing shelf, cm Tabletop Not specified (1) Not specified (1) None Installation Manual Mobile on wheels Mobile on wheels Not specified POWER REQUIRED, 110/ , Hz , Hz NA (pneumatic) VAC Auxiliary outlets Not specified Optional 4 NA BACKUP BATTERY NA Yes Yes NA (pneumatic) Type NA Lead acid Lead acid NA Use per charge, hr NA 2 4 NA PURCHASE INFORMATION Price Y1,100,000 (US $9,800); Y690,000 (US$6,100) optional ventilator Not specified Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Not specified Optional Optional At variable cost Delivery time, ARO ~50 days 4-6 weeks 4-6 weeks 4-8 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Clear hard acrylic cover (up-close/down-open sliding type) protects front control panel of ventilator; heavyduty steel finished chassis; 2-tone color; footrest; antistatic casters; stainless steel tabletop; monitor shelf. None specified. None specified. Specially designed for use in field hospitals and similar locations; MP-1 is a basic draw-over machine; MP-2 includes bypass valve and rotameter box. 74

75 MODEL NORMECA PENLON PENLON PENLON MP-3 SP101 SP101R Rail Model SP102 WHERE MARKETED Worldwide, except North Worldwide Worldwide Worldwide America FDA CLEARANCE No Submitted Submitted Submitted CE MARK (MDD) No Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 2, 3, or 4 (O2, N2O, air, CO2) 2, 3, or 4 (O2, N2O, air, CO2) 2, 3, or 4 (O2, N2O, air, CO2) GAS CYLINDER YOKES No 3 maximum 2 maximum, separate rack 4 maximum VAPORIZERS, AGENTS Halothane, enflurane, trilene, isoflurane Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, isoflurane, enflurane Type Variable bypass Plenum Plenum Plenum Number Interlock No Yes Yes Yes SUCTION SYSTEM Yes Optional Optional Optional O2 FAIL-SAFE No Yes Yes Yes HYPOXIC MIXTURE FAIL-SAFE No Integrated mechanical, paramagnetic, fuel cell Integrated mechanical, paramagnetic, fuel cell Integrated mechanical, paramagnetic, fuel cell AUTOMATIC VENTILATOR Yes Optional integrated AV-S 1 Integrated AV800/900 1 Optional integrated AV800/900 1 BELLOWS, SIZE Adult/pediatric Adult/pediatric Adult/pediatric Adult/pediatric Type Ascending, bag in bottle Ascending Ascending Ascending Primary controls Control knob and touchscreen Ventilation modes CMV Standby, Volume, Pressure, Spontaneous, SIMV, SMMV, Pressure Support Standby, volume, spontaneous pressure Standby, volume, spontaneous pressure Tidal volume Yes Yes Yes Yes Range, cc 50-1, ,600 (adult) ,600 (adult) ,600 (adult) 2 Minute volume No No No No Range, L/min NA NA NA NA Frequency, bpm Inspiratory flow, L/min 0-50 NA NA NA IE ratio 1:2 1:0.3 to 1:8 1:0.3 to 1:8 1:0.3 to 1:8 Inspiratory pause Not specified 25% Ti 25% Ti 25% Ti Pressure limit, cm 25-85, adjustable 10-80, adjustable 10-70, adjustable 10-70, adjustable H2O PEEP, cm H2O Optional Other controls Float-type flowmeter Print button, spirometry, oxygen monitor, freeze waveform Standby, spontaneous mode, print button, spirometry, oxygen Standby, print button, spirometry, oxygen monitor monitor System checks None Ventilator self-test Ventilator self-test Ventilator self-test SCAVENGING SYSTEM Optional Optional vacuum or Optional vacuum or Optional vacuum or exhaust exhaust exhaust AUTO RECORD No No No No KEEPER ANESTHESIA DATA No Optional Optional Optional MANAGEMENT This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 75

76 MODEL NORMECA PENLON PENLON PENLON MP-3 SP101 SP101R Rail Model SP102 MONITORS Airway pressure No Yes Yes Yes Where measured NA Inspiratory limb Inspiratory limb Inspiratory limb High-pressure NA Variable Variable Variable Subatmospheric NA Yes Yes Yes pressure Continuing pressure NA Yes Yes Yes Low pressure/apnea NA Yes Yes Yes Other pressure s NA See footnote 3 See footnote 3 See footnote 3 Expiratory volume/flow No Yes Yes Yes Type of sensor NA Differential press Differential press Differential press Where measured NA In circle In circle In circle Rate NA No No No Apnea NA Yes Yes Yes Reverse-flow NA Yes Yes Yes High/low minute NA Yes Yes Yes volume High/low flow NA Yes Yes Yes Other expiratory NA No No No s O2 concentration No Integrated Integrated Integrated Type of sensor NA Fuel cell Paramagnetic, fuel cell Paramagnetic, fuel cell Response time, sec NA 20 to 95% FSD CO2 concentration No No No No Apnea NA Yes NA NA N2O No No No No Agent monitors No No No No Type of agents NA NA NA NA Auto ID NA NA NA NA Agent concentration NA NA NA NA ECG No Not specified Not specified Not specified Heart rate NA Not specified Not specified Not specified ST segment NA Not specified Not specified Not specified Noninvasive BP No Not specified Not specified Not specified Invasive BP No Not specified Not specified Not specified Temperature No Not specified Not specified Not specified Pulse oximeter No Not specified Not specified Not specified Other monitors None None specified None specified None specified Other features None specified MRI compatible MRI compatible MRI compatible This is the second of three pages covering the above model(s). These specifications continue onto the next page. 76

77 MODEL NORMECA PENLON PENLON PENLON MP-3 SP101 SP101R Rail Model SP102 DISPLAYS No AV900 AV900 AV900 Number NA Type NA LED LED EL touchscreen Integrated NA Modular Modular Yes Interface with others NA Spacelabs, Agilent Spacelabs, Agilent Spacelabs, Agilent DATA INPUT No No No No PRIORITIZED ALARMS No Yes Yes Yes PHYSICAL FEATURES H x W x D, cm 57 x 78 x x 46 x x 46 x x 66 x 66 Weight, kg Shelves, cm 25 x 43 (1) 48 x 40, 45 x 37 None 61 x 40, 61 x 37 Drawers, cm None 15 x 38 x 43 (3 maximum) None 15 x 38 x 43 (3 maximum) Writing shelf, cm None 22 x 30 (1) None 22 x 30 (1) Installation Not specified Mobile Wall-mounted rail Mobile POWER REQUIRED, VAC /240, universal power supply Not specified Auxiliary outlets None 4 None 4 BACKUP BATTERY No Yes Yes Yes Type NA Sealed lead-acid Sealed lead-acid Sealed lead-acid Use per charge, hr NA PURCHASE INFORMATION Price Not specified 6,000-18,000 (US$9,537-28,611) 6,000-18,000 (US$9,537-28,611) Warranty 1 year 1 year 1 year 1 year Service contract At variable cost Yes Yes Yes Delivery time, ARO 4-8 weeks 4-8 weeks 4-8 weeks 4-8 weeks OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Specially designed for use in field hospitals and similar locations; includes bypass valve, rotameter box, ventilator, bag in bottle, and suction unit. Modular system with monitoring options; options include vaporizer, A100 absorber, coaxial circuits, IV pole, cable management system, suction regulator, and receivers. Meets requirements of BS, CSA, DIN, ISO, JIS, and TUV. 1 Latex-free and autoclavable. 2 Fresh gas compensated. 4 Pressure versus time display, volume versus time display, compliance loop. Modular system with monitoring options; options include vaporizer, A100 absorber, coaxial circuits, IV pole, cable management system, suction regulator, and receivers. Meets requirements of BS, CSA, DIN, ISO, JIS, and TUV. 1 Latex-free and autoclavable. 2 Fresh gas compensated. 3 Pressure versus time display, volume versus time display, compliance loop. 110/240, universal power supply 6,000-18,000 (US$9,537-28,611) Modular system with monitoring options; options include vaporizer, A100 absorber, coaxial circuits, IV pole, cable management system, suction regulator, and receivers. Meets requirements of BS, CSA, DIN, ISO, JIS, and TUV. 1 Latex-free and autoclavable. 2 Fresh gas compensated. 3 Pressure versus time display, volume versus time display, compliance loop. 77

78 MODEL PENLON PENLON PNEUPAC PNEUPAC SP102 Rail Model SP102P Pendant Model : 550 WHERE MARKETED Worldwide Worldwide Worldwide, except USA Worldwide, except USA FDA CLEARANCE Submitted Submitted No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 2, 3, or 4 (O2, N2O, air, 2, 3 (O2, N2O, air) 2 (O2, N2O) 3 (O2, N2O, air) CO2) GAS CYLINDER YOKES 2 maximum, separate rack 2 maximum No 4 (O2, N2O) : 4 (O2, N2O, air) VAPORIZERS, AGENTS Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, enflurane, isoflurane Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, isoflurane, enflurane Type Plenum Plenum Variable bypass Variable bypass Number maximum 1 maximum : 2 maximum Interlock Yes Yes NA NA : Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Yes Yes Audio and visual Audio and visual HYPOXIC MIXTURE Integrated mechanical, Integrated mechanical, Yes Yes FAIL-SAFE paramagnetic, fuel cell paramagnetic, fuel cell AUTOMATIC Integrated AV800/900 Optional integrated AV900 Optional Optional VENTILATOR BELLOWS, SIZE Adult/pediatric Adult/pediatric 350 or 1,500 ml 350 or 1,500 ml Type Ascending Ascending Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes Standby, volume, Standby, volume, CMV, manual CMV, manual spontaneous pressure spontaneous pressure Tidal volume Yes Yes Yes Yes Range, cc 20-1,600 (adult) ,600 (adult) 1 5-2, ,000 Minute volume No No No No Range, L/min NA NA NA NA Frequency, bpm , , 8-60 Inspiratory flow, L/min NA NA IE ratio 1:0.3 to 1:8 1:0.3 to 1:8 Infinitely adjustable Infinitely adjustable Inspiratory pause 25% Ti 25% Ti No No Pressure limit, cm 10-70, adjustable 10-70, adjustable H2O PEEP, cm H2O integrated Optional Optional Other controls Standby, spontaneous Standby, spontaneous None APL valve mode, print button, spirometry, oxygen monitor mode, print button, spirometry, oxygen monitor System checks Ventilator self-test Ventilator self-test None specified None specified SCAVENGING SYSTEM Optional vacuum or Optional vacuum or No Optional exhaust exhaust AUTO RECORD No No No No KEEPER ANESTHESIA DATA MANAGEMENT Optional Optional No No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 78

79 MODEL PENLON PENLON PNEUPAC PNEUPAC SP102 Rail Model SP102P Pendant Model : 550 MONITORS Airway pressure Yes Yes With ventilator With ventilator Where measured Inspiratory limb Inspiratory limb Ventilator output Ventilator output High-pressure Variable Variable Yes Yes Subatmospheric Yes Yes No No pressure Continuing pressure Yes Yes Optional Optional Low pressure/apnea Yes Yes Optional Optional Other pressure s See footnote 2 See footnote 2 None None Expiratory volume/flow Yes Yes No No Type of sensor Differential press Differential press NA NA Where measured In circle In circle NA NA Rate No No NA NA Apnea Yes Yes NA NA Reverse-flow Yes Yes NA NA High/low minute Yes Yes NA NA volume High/low flow Yes Yes NA NA Other expiratory NA No NA NA s O2 concentration Integrated Integrated No No Type of sensor Paramagnetic, fuel cell Paramagnetic, fuel cell NA NA Response time, sec NA NA CO2 concentration No No No No Apnea NA NA NA NA N2O No No No No Agent monitors No No No No Type of agents NA NA NA NA Auto ID NA NA NA NA Agent concentration NA NA NA NA ECG Not specified Not specified No No Heart rate Not specified Not specified NA NA ST segment Not specified Not specified NA NA Noninvasive BP Not specified Not specified No No Invasive BP Not specified Not specified No No Temperature Not specified Not specified No No Pulse oximeter Not specified Not specified No No Other monitors None specified None specified None None Other features MRI compatible MRI compatible None None specified This is the second of three pages covering the above model(s). These specifications continue onto the next page. 79

80 MODEL PENLON PENLON PNEUPAC PNEUPAC SP102 Rail Model SP102P Pendant Model : 550 DISPLAYS AV900 AV800 O2 monitor No No Number 2 2 NA NA Type LED LED NA NA Integrated Modular Modular NA NA Interface with others Spacelabs, Agilent Spacelabs, Agilent NA NA DATA INPUT No No No No PRIORITIZED ALARMS Yes Yes No No PHYSICAL FEATURES H x W x D, cm 54 x 66 x x 66 x x 40 x x 52 x 44 : 146 x 67 x 67 Weight, kg : 75 Shelves, cm None None None 52 x 42 : 58 x 31 Drawers, cm None None None 4.3 x 13 x 30 : 50 x 40 x 12.5 Writing shelf, cm None None 40 x x 31 : 53 x 31 Installation Wall-mounted rail Pendant NA (handheld, portable machine) Mobile : Transportable (both with wheels) POWER REQUIRED, Not specified 110/240, universal power None None VAC supply Auxiliary outlets None 4 None Optional (4-240 AC only) BACKUP BATTERY Yes Yes Not required Not required Type Sealed lead-acid Sealed lead-acid NA NA Use per charge, hr NA NA PURCHASE INFORMATION Price 6,000-18,000 (US$9,537-28,611) 6,000-18,000 (US$9,537-28,611) 1,236-5,044 (US$1,416-5,780) 3,086-10,872 (US$3,536-12,454) Warranty 1 year 1 year 1 year Available Service contract Yes Yes Available Not specified Delivery time, ARO 4-8 weeks 4-8 weeks 60 working days 60 working days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Modular system with monitoring options; options include vaporizer, A100 absorber, coaxial circuits, IV pole, cable management system, suction regulator, and receivers. Meets requirements of BS, CSA, DIN, ISO, JIS, and TUV. 1 Fresh gas compensated. 2 Pressure versus time display, volume versus time display, compliance loop. Modular system with monitoring options; options include vaporizer, A100 absorber, coaxial circuits, IV pole, cable management system, suction regulator, receivers. Meets requirements of BS, CSA, DIN, ISO, JIS, and TUV. 1 Fresh gas compensated. 2 Pressure versus time display, volume versus time display, compliance loop. Portable unit with handles; pipeline gauges. Meets requirements of BS 4272, EN 740, and ISO , 5358, and Mobile, modular unit; use in smaller ORs, casualty departments, field hospitals, and anesthetic rooms : Modular, transportable unit designed for applications within OR, induction rooms, and casualty departments. Both meet requirements of BS 4272, EN 740, and ISO , 5358, and

81 MODEL PNEUPAC PNEUPAC ROYAL MEDICAL ROYAL MEDICAL MRI Multiplus 1 Royal 77 1 WHERE MARKETED Worldwide, except USA Worldwide, except USA Worldwide Worldwide FDA CLEARANCE No No Submitted Submitted CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 2 (O2, N2O), 3 (O2, N2O, air) 2 (O2, N2O), 3 (O2, N2O, air) GAS CYLINDER YOKES No 3 (O2, N2O, air) 2 max 4 maximum optional VAPORIZERS, AGENTS Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, isoflurane, enflurane Halothane, sevoflurane, enflurane, isoflurane Halothane, sevoflurane, enflurane, isoflurane Type Variable bypass Variable bypass Variable bypass Variable bypass Number 2 maximum 1 max with optional 1 or 2 optional 2 or 3 parking Interlock Yes NA Optional Optional SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Audio and visual Audio and visual Audible Audible HYPOXIC MIXTURE Yes Yes Yes Yes FAIL-SAFE AUTOMATIC Optional Optional Yes Yes VENTILATOR BELLOWS, SIZE 350 or 1,500 ml 350 or 1,500 ml Adult/pediatric Adult/pediatric Type Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Ascending, bag in bottle Primary controls Ventilation modes CMV, manual CMV, manual CMV, manual CMV, manual Tidal volume No No Yes Yes Range, cc 5-2, , ,500; pediatric 100-1,500; pediatric Minute volume No No No No Range, L/min NA NA NA NA Frequency, bpm 5-50, , Inspiratory flow, L/min Not specified Not specified IE ratio Infinitely adjustable Infinitely adjustable 1:1 to 1:3 1:1 to 1:3 Inspiratory pause No No No Not specified Pressure limit, cm H2O PEEP, cm H2O Optional Optional Other controls APL valve APL valve Float-type flowmeter Float-type flowmeter System checks None specified None specified None None SCAVENGING SYSTEM Optional Optional Active or passive Active or passive AUTO RECORD No No No No KEEPER ANESTHESIA DATA MANAGEMENT No No No No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 81

82 MODEL PNEUPAC PNEUPAC ROYAL MEDICAL ROYAL MEDICAL MRI Multiplus 1 Royal 77 1 MONITORS Airway pressure With ventilator With ventilator Optional Optional Where measured Ventilator output Ventilator output Optional Optional High-pressure Yes Yes Optional Optional Subatmospheric No No Optional Optional pressure Continuing pressure Optional Optional Optional Optional Low pressure/apnea Optional Optional Optional Optional Other pressure s None None Optional Optional Expiratory volume/flow No No Optional Optional Type of sensor NA NA Optional Optional Where measured NA NA Optional Optional Rate NA NA Optional Optional Apnea NA NA Optional Optional Reverse-flow NA NA Optional Optional High/low minute NA NA Optional Optional volume High/low flow NA NA Optional Optional Other expiratory NA NA Optional Optional s O2 concentration No No No No Type of sensor NA NA NA NA Response time, sec NA NA NA NA CO2 concentration No No No No Apnea NA NA NA NA N2O No No No No Agent monitors No No No No Type of agents NA NA NA NA Auto ID NA NA NA NA Agent concentration NA NA NA NA ECG No No No No Heart rate NA NA NA NA ST segment NA NA NA NA Noninvasive BP No No No No Invasive BP No No No No Temperature No No No No Pulse oximeter No No No No Other monitors None None None None Other features None None specified None None This is the second of three pages covering the above model(s). These specifications continue onto the next page. 82

83 MODEL PNEUPAC PNEUPAC ROYAL MEDICAL ROYAL MEDICAL MRI Multiplus 1 Royal 77 1 DISPLAYS No No Yes Yes Number NA NA 1 1 Type NA NA LED LED Integrated NA NA Yes Yes Interface with others NA NA No No DATA INPUT No No Keys Keys PRIORITIZED ALARMS No No Not specified Not specified PHYSICAL FEATURES H x W x D, cm 50 x 60 x x 56 x x 45 x x 62 x 61 Weight, kg Shelves, cm 60 x x x 40 Not specified Drawers, cm None None 15 x 40 (2) Not specified Writing shelf, cm 60 x x 23 None Not specified Installation Wall-mounted MRI machine Mobile Mobile POWER REQUIRED, None None Not specified Not specified VAC Auxiliary outlets None None None 3 BACKUP BATTERY Not required Not required Yes Yes Type NA NA Not specified Not specified Use per charge, hr NA NA PURCHASE INFORMATION Price 1,914-6,747 (US$2,192-7,728) 4,158-11,323 (US$4,763-12,970) Not specified Warranty 1 year 1 year 1 year 1 year Service contract Available Available Yes Yes Delivery time, ARO 60 working days 60 working days 30 days 30 days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Wall-mounted unit; for use in anesthesia rooms, casualty departments, maternity suites, and plaster rooms. Meets requirements of BS 4272, EN 740, and ISO , 5358, and Designed for use in MRI suite; mobile. Meets requirements of BS 4272, EN 740, and ISO , 5358, and None specified. 1 Multi Plus M (2 gassed machine, vaporizer, single CO2 absorber); Multi Plus MI (2 gassed machine, vaporizer, single absorber, I type mobile stand); Multi Plus ME (2 gassed machine, vaporizer, single CO2 absorber, E-type mobile stand); Multi Plus MEV (2 gassed machine, vaporizer, single CO2 absorber, E-type mobile stand, ventilator); Multi Plus MEVD (2 gassed machine, vaporizer, dual CO2 absorber, E-type mobile stand, ventilator). Not specified None specified. 1 2 gassed machine, 2 vaporizers, Compact absorber system, ventilator with tidal and minute volume monitoring. 83

84 MODEL ROYAL MEDICAL SAMED SIARE SIARE Roytech 2 1 Anesthesia Unit "Inox" in AM 5000 MORPHEUS Stainless Steel WHERE MARKETED Worldwide Worldwide, except USA Worldwide, except USA Worldwide, except USA FDA CLEARANCE Submitted No Not specified Not specified CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 2 or 3 (O2, N2O, air) 2 (O2, N2O), 3 (O2, N2O, 3 (O2, N2O, air) air) GAS CYLINDER YOKES 4 maximum optional 2 (O2, N2O) 2 (O2, N2O) 2 (O2, N2O) VAPORIZERS, AGENTS Halothane, sevoflurane, enflurane, isoflurane Halothane, isoflurane Type Variable bypass Vaportec III Variable bypass Variable bypass Number 2 or 3 1 1, Interlock Optional Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Optional O2 FAIL-SAFE Audible Audible Audible Audible HYPOXIC MIXTURE FAIL-SAFE Yes Yes Visual Audible (visual with electronic flow meter) AUTOMATIC Yes Optional Optional Yes VENTILATOR BELLOWS, SIZE Adult/pediatric Adult/pediatric Adult/pediatric Adult/pediatric Type Ascending, bag in bottle ABV-U Vertical Vertical Primary controls Ventilation modes CMV, manual Electronic, see Other Specifications IPPV, manual Tidal volume Yes Yes Yes Yes Range, cc 0-1, (0-40 ped) 50-1, ,500 Minute volume No Yes Yes Yes Range, L/min NA Frequency, bpm Inspiratory flow, L/min Not specified IE ratio 1:1 to 1:3 1:4 to 2:1 1:1.5 1:4 to 3:1 Inspiratory pause 0-60% No No Yes Manual, IPPV, IMV, PCV, SIMV, assisted IPPV, PSV, apnea backup Pressure limit, cm , adjustable H2O PEEP, cm H2O Optional 0-20 variable Other controls Float-type flowmeter Float-type flowmeter and None Trigger, effort manometer System checks Tidal volume compliance, pre-use check for leaks Block N2O, audible, patient disconnect, None Yes stenosis SCAVENGING SYSTEM Active or passive Optional Optional active and Optional active and passive passive AUTO RECORD No No No No KEEPER ANESTHESIA DATA No No Optional Optional MANAGEMENT This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 84

85 MODEL ROYAL MEDICAL SAMED SIARE SIARE Roytech 2 1 Anesthesia Unit "Inox" in AM 5000 MORPHEUS Stainless Steel MONITORS Airway pressure Optional No Electronic Electronic Where measured Optional NA Y-piece Y-piece High-pressure Optional NA 50 cm H2O 0-80 cm H2O Subatmospheric Optional NA Yes Yes pressure Continuing pressure Optional NA Yes Yes Low pressure/apnea Optional NA Yes Yes Other pressure s Optional NA Yes Yes Expiratory volume/flow Optional No Optional Yes Type of sensor Optional NA Electronic Electronic Where measured Optional NA Expiratory line Expiratory line Rate Optional NA No Yes Apnea Optional NA Yes Yes Reverse-flow Optional NA Yes Yes High/low minute Optional NA Optional Yes volume High/low flow Optional NA No Yes Other expiratory Optional NA Optional Yes s O2 concentration Optional No Optional Yes Type of sensor Optional NA Galvanic cell Galvanic cell Response time, sec Optional NA Not specified Not specified CO2 concentration Optional No Optional Optional Apnea Optional NA Yes Yes N2O No No Optional Optional Agent monitors No No Optional Optional Type of agents NA NA Auto ID NA NA Yes Yes Agent concentration NA NA Yes Yes ECG No No Optional Optional Heart rate NA NA Yes Yes ST segment NA NA Yes Yes Noninvasive BP No No Optional Optional Invasive BP No No Optional Optional Temperature No No Optional Optional Pulse oximeter No No Optional Optional Other monitors None None None None Other features None None None Respiratory mechanics This is the second of three pages covering the above model(s). These specifications continue onto the next page. 85

86 MODEL ROYAL MEDICAL SAMED SIARE SIARE Roytech 2 1 Anesthesia Unit "Inox" in AM 5000 MORPHEUS Stainless Steel DISPLAYS Yes Not specified Optional Yes Number 1 Not specified 1 1 Type TFT LCD Not specified LCD LCD Integrated Yes Not specified Yes Yes Interface with others No Not specified No Yes DATA INPUT Encoded keys Not specified Knobs, keyboard Knobs, keyboard PRIORITIZED ALARMS Not specified Not specified Yes Yes PHYSICAL FEATURES H x W x D, cm Not specified x 56 x 50 : x 145 x 55 x x 80 x x 51 Weight, kg : 47 (both without ventilator) Shelves, cm Not specified 39 x 56 : 35 x x 30 (1) 60 x 35 Drawers, cm Not specified x 47 x 32 : 16.5 x 34 x 29 x 7 (2) 38 x 36 x x 30 Writing shelf, cm Not specified 54 x 31 : 34 x x 37 (1) 32 x 27 Installation Mobile On 4 antistatic wheels Mobile, pendant Mobile, pendant POWER REQUIRED, Not specified No 110/ /220 VAC Auxiliary outlets 3 No Optional Optional BACKUP BATTERY Yes No Yes Yes Type Not specified NA NA Lead acid Use per charge, hr 0.5 NA NA 4 PURCHASE INFORMATION Price Not specified ~ITL 16,000,000 Not specified Not specified (US$8,880); see Other Specs Warranty 1 year 1 year 1 year 1 year Service contract Yes Yes Yes Yes Delivery time, ARO 30 days 1 week, with ventilator 30 days days days OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes None specified. 1 3 gassed machine, 2 vaporizers, Compact absorber system, ventilator with tidal and minute volume monitoring. Ventilation modes: CMV, S-CMV, PCV, S-PCV, IPPV, IMV, SV-CPAP, and manual; price varies by customer request (with or without vaporizer, ventilator, or gas scavenging system); 3,200 (US$3,590) for simple anesthesia unit. Low-flow system. Meets requirements of IEC Low-flow system. Meets requirements of IEC

87 MODEL SIARE TAEMA TAEMA TAEMA PERSEO Alys 2000 Clarys 2000 Felix Visio Integra WHERE MARKETED Worldwide, except USA Worldwide, except North America Worldwide, except North America Worldwide, except North America FDA CLEARANCE Not specified No No No CE MARK (MDD) Yes Yes Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES 2 (O2, N2O) 2 optional (O2, air) 2 optional (O2, air) 2 optional (O2, air) VAPORIZERS, AGENTS isoflurane, halothane, isoflurane, halothane, Variable bypass, heated isoflurane, halothane, Type Variable bypass Variable bypass, heated Variable bypass, heated () () () Number 1, active, 2 storage 2 Interlock Yes Yes Yes Yes SUCTION SYSTEM Optional Optional Optional Yes O2 FAIL-SAFE Audible Acoustic, N2O block Acoustic, N2O block Acoustic and visual, N2O block HYPOXIC MIXTURE FAIL-SAFE Audible Mechanical limit, O2 Mechanical limit, O2 O2 ratio controller, O2 AUTOMATIC VENTILATOR Yes Electronic controls, pneumatically driven Electronic controls, pneumatically driven Electronic controls, pneumatically driven BELLOWS, SIZE Adult/pediatric 1 size 1 size 1 size Type Vertical Descending Descending Ascending Primary controls Ventilation modes Manual, IPPV, IMV, PCV, SIMV, assisted IPPV, PSV, apnea backup Manual, spontaneous, VC, PCV Manual, spontaneous, VC, PCV Manual, spontaneous, VC, PCV, PS Tidal volume Yes Yes Yes Yes Range, cc 20-1, , , ,500 Minute volume Yes Yes Yes Yes Range, L/min Frequency, bpm Inspiratory flow, L/min maximum IE ratio 1:4 to 3:1 1:3 to 1:1 1:3 to 1:1 1:5.5 to 4:1 Inspiratory pause Yes 0-20% Ti 0-20% Ti 0-20% Ti Pressure limit, cm 0-80, adjustable 10-90, adjustable 10-90, adjustable 10-80, adjustable H2O PEEP, cm H2O 0-20 variable 0-25 electronic 0-25 electronic 0-20 electronic Other controls Trigger, effort Plateau sigh, expiratory pause Plateau sigh, expiratory pause Plateau sigh, expiratory pause System checks Yes Autotest, leakage, compliance Autotest, leakage, compliance Autotest, system autotest, leakage compliance SCAVENGING SYSTEM Optional active and Vacuum/exhaust Vacuum/exhaust Vacuum/exhaust passive AUTO RECORD No Not specified Not specified Not specified KEEPER ANESTHESIA DATA MANAGEMENT Optional External optional, digital output, RS232 External optional, digital output, RS232 External optional, digital output, RS232 This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 87

88 MODEL SIARE TAEMA TAEMA TAEMA PERSEO Alys 2000 Clarys 2000 Felix Visio Integra MONITORS Airway pressure Electronic Piezoelectric Piezoelectric Piezoelectric Where measured Y-piece Inspiratory limb Inspiratory limb Inspiratory limb High-pressure 0-80 cm H2O mbar mbar mbar Subatmospheric Yes Yes Yes Yes pressure Continuing pressure Yes Yes Yes Yes Low pressure/apnea Yes Yes Yes Yes Other pressure s Yes None specified None specified High and low gas supply Expiratory volume/flow Yes Yes Yes Yes Type of sensor Electronic Hot wire Hot wire Hot wire Where measured Expiratory line Expiratory port Expiratory port Expiratory port Rate Yes Yes Yes Yes Apnea Yes Yes Yes Yes Reverse-flow Yes Yes Yes Yes High/low minute volume Yes Yes Yes Yes High/low flow Yes No No No Other expiratory s Yes Sensor disconnect, sensor fail Sensor disconnect, sensor fail O2 concentration Yes Yes Yes Yes Type of sensor Galvanic cell Galvanic cell Galvanic cell Paramagnetic Response time, sec Not specified 5 5 Not specified CO2 concentration Optional External optional External optional Sidestream IR Apnea Yes External optional External optional Automatic N2O Optional External optional External optional Sidestream IR Agent monitors Optional External optional External optional Yes Type of agents Sensor disconnect, sensor fail, leakage External optional External optional isoflurane, halothane, Auto ID Yes External optional External optional Yes Agent concentration Yes External optional External optional Yes ECG Optional External optional External optional External optional Heart rate Yes External optional External optional External optional ST segment Yes External optional External optional External optional Noninvasive BP Optional External optional External optional External optional Invasive BP Optional External optional External optional External optional Temperature Optional External optional External optional External optional Pulse oximeter Optional External optional External optional External optional Other monitors None None None None Other features Respiratory mechanics (optional) None specified None specified Stored trend, loops F37 This is the second of three pages covering the above model(s). These specifications continue onto the next page. 88

89 MODEL SIARE TAEMA TAEMA TAEMA PERSEO Alys 2000 Clarys 2000 Felix Visio Integra DISPLAYS Optional Yes Yes Yes Number Type LCD ED ED TFT LCD Integrated Yes Yes Not specified Yes Interface with others No Yes (through RS232) Yes (through RS232) Yes (through RS232) DATA INPUT Knobs, keyboard Rotary knob, softkeys, hardkeys Rotary knob, softkeys, hardkeys Rotary knob, softkeys, hardkeys PRIORITIZED ALARMS Yes Yes Yes 3 (caution, advisory, ) PHYSICAL FEATURES H x W x D, cm 144 x 80 x x 69 x x 74 x 75 or 75 x 60 x 160 x 60 x Weight, kg or Shelves, cm 42 x 30 (1) Not specified Not specified Not specified Drawers, cm 34 x 29 x 7 (2) Not specified Not specified Not specified Writing shelf, cm 31 x 31 Not specified Not specified Not specified Installation Mobile, pendant Mobile Mobile, wall, pendant Mobile POWER REQUIRED, 110/ / /240 90/264 VAC Auxiliary outlets Optional BACKUP BATTERY Yes Optional Optional Yes Type Lead acid Not specified Not specified Lead acid Use per charge, hr 4 Not specified Not specified 0.7 with gas monitoring PURCHASE INFORMATION Price Not specified Not specified Not specified Not specified Warranty 1 year 1 year 1 year 1 year Service contract Yes Yes Yes Yes Delivery time, ARO days Not specified Not specified Not specified OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes Low-flow system. Meets requirements of IEC Automatic compliance compensation; automatic sensor calibration. Automatic compliance compensation; automatic sensor calibration cm (15") color display; software for diagnostic and maintenance; left- and right-hand machine; airway tightness check function; optional MAC and CEC functions. 89

90 MODEL TAEMA ULCO Felix Visio O2C Integrus WHERE MARKETED Worldwide, except North Worldwide America FDA CLEARANCE No Submitted CE MARK (MDD) Yes Yes PIPELINE GAS INLETS 3 (O2, N2O, air) 3 (O2, N2O, air) GAS CYLINDER YOKES 2 optional (O2, air) 3 (O2, N2O, air) VAPORIZERS, AGENTS Any isoflurane, halothane, Type Variable bypass, heated Variable bypass () Number 2 2 Interlock Yes Yes SUCTION SYSTEM Yes Optional O2 FAIL-SAFE Acoustic and visual, N2O block Pneumatic with N2O cutoff HYPOXIC MIXTURE O2 ratio controller, O2 Ratio controlled, 25% O2 FAIL-SAFE AUTOMATIC VENTILATOR Electronic controls, pneumatically driven Pressure or volume controlled BELLOWS, SIZE 1 size Adult/infant Type Ascending Ascending, bag in bottle Primary controls Ventilation modes Manual, spontaneous, VC, PCV, PS Tidal volume Yes Yes Range, cc 20-1, ,300 Minute volume Yes Yes Range, L/min Not specified Frequency, bpm Inspiratory flow, L/min 120 maximum IE ratio 1:5.5 to 4:1 1:0.5 to 1:9 Inspiratory pause 0-20% Ti 0-30% CMV, SIMV, PEEP, CPAP, PSV Pressure limit, cm 10-80, adjustable 0-70 H2O PEEP, cm H2O 0-20 electronic 0-30 Other controls Plateau sigh, expiratory Low- and high-limit s pause System checks Autotest, system autotest, leakage, compliance Leakage, compliance; FG compensates for compliance SCAVENGING SYSTEM Vacuum/exhaust Active or passive AUTO RECORD Not specified No KEEPER ANESTHESIA DATA MANAGEMENT External optional, digital output, RS232 No This is the first of three pages covering the above model(s). These specifications continue onto the next two pages. 90

91 MODEL TAEMA ULCO Felix Visio O2C Integrus MONITORS Interface to Philips IntelliVue (not supplied by Ulco) Airway pressure Piezoelectric Yes Where measured Inspiratory limb Proximal airway High-pressure mbar Yes Subatmospheric Yes Yes pressure Continuing pressure Yes Yes (cycle) Low pressure/apnea Yes Yes Other pressure s High and low gas supply None Expiratory volume/flow Yes Yes Type of sensor Hot wire Generic/non-specific Where measured Expiratory port Proximal airway Rate Yes No Apnea Yes 6-60 adjustable Reverse-flow Yes No High/low minute Yes Yes volume High/low flow No No Other expiratory Sensor disconnect, sensor Yes s fail, leakage O2 concentration Yes Yes Type of sensor Galvanic cell Not specified Response time, sec Not specified 3 msec CO2 concentration External optional No Apnea External optional NA N2O External optional No Agent monitors External optional No Type of agents External optional NA Auto ID External optional NA Agent concentration External optional NA ECG External optional No Heart rate External optional NA ST segment External optional NA Noninvasive BP External optional No Invasive BP External optional No Temperature External optional No Pulse oximeter External optional No Other monitors None None Other features Stored trend, loops F37 None This is the second of three pages covering the above model(s). These specifications continue onto the next page. 91

92 MODEL TAEMA ULCO Felix Visio O2C Integrus DISPLAYS Yes Yes Number 1 1 Type TFT LCD Color LCD Integrated Yes Yes Interface with others Yes (through RS232) Yes DATA INPUT Rotary knob, softkeys, Trimknob hardkeys PRIORITIZED ALARMS 3 (caution, advisory, Yes ) PHYSICAL FEATURES H x W x D, cm 160 x 60 x x 65 x 140 Weight, kg Shelves, cm Not specified 56.2 x 40 (1) Drawers, cm Not specified 56.5 x 42 x 15 (2) Writing shelf, cm Not specified 56 x 32, working table (1) Installation Mobile Mobile POWER REQUIRED, 90/ /240 VAC Auxiliary outlets 4 4 BACKUP BATTERY Yes Optional Type Lead acid Not specified Use per charge, hr 0.7 with gas monitoring 1 PURCHASE INFORMATION Price Not specified A$42,000-48,000 (US$27,325-31,223) Warranty 1 year 1 year Service contract Yes Not specified Delivery time, ARO Not specified Not specified OTHER SPECIFICATIONS Supplier Footnotes Model Footnotes Data Footnotes 38.1 cm (15") color display; software for diagnostics and maintenance; left- and right-hand machine; airways tightness check function and CEC function options. Modular unit; monitoring of physiologic parameters depends on monitoring system chosen by customer. Meets requirements of IEC 601 and TGA. 92